II 

Calendar No. 161 

111TH CONGRESS 

1ST SESSION S. 1679 

To make quality, affordable health care available to all Americans, reduce 

costs, improve health care quality, enhance disease prevention, and 

strengthen the health care workforce. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 17, 2009 

Mr. HARKIN, from the Committee on Health, Education, Labor, and Pensions 

reported the following original bill; which was read twice and placed on 

the calendar 

A BILL 

To make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance 

disease prevention, and strengthen the health care workforce. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Affordable Health Choices Act’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—QUALITY, AFFORDABLE HEALTH CARE FOR ALL 

AMERICANS 

Subtitle A—Effective Coverage for All Americans 

PART I—PROVISIONS APPLICABLE TO THE INDIVIDUAL AND GROUP

MARKETS

Sec. 101. Amendment to the Public Health Service Act. 

‘‘PART A—INDIVIDUAL AND GROUP MARKET REFORMS

‘‘SUBPART 1—GENERAL REFORM

‘‘Sec. 2705. Prohibition of preexisting condition exclusions or other discrimination based on health status. 

‘‘Sec. 2701. Fair insurance coverage. 

‘‘Sec. 2702. Guaranteed availability of coverage. 

‘‘Sec. 2703. Guaranteed renewability of coverage. 

‘‘Sec. 2704. Increasing the Transparency of Health Care Costs and Regulatory Fees. 

‘‘Sec. 2706. Prohibiting discrimination against individual participants and 

beneficiaries based on health status. 

‘‘Sec. 2707. Ensuring the quality of care. 

‘‘Sec. 2708. Coverage of preventive health services. 

‘‘Sec. 2709. Coverage of Preventive Women’s Health Services. 

‘‘Sec. 2710. Extension of dependent coverage. 

‘‘Sec. 2711. No lifetime or annual limits. 

‘‘Sec. 2712. Notification by plans not providing minimum qualifying coverage. 

‘‘Sec. 2713. Non-discrimination in health care. 

PART II—PROVISION APPLICABLE TO THE GROUP MARKET

Sec. 121. Amendment to the Public Health Service Act. 

‘‘Sec. 2720A. Prohibition of discrimination based on salary. 

PART III—OTHER PROVISIONS

Sec. 131. No changes to existing coverage. 

Sec. 132. Applicability. 

Sec. 133. Conforming amendments. 

Sec. 134. Savings. 

Sec. 135. Effective dates. 

Subtitle B—Available Coverage for All Americans 

Sec. 141. Building on the success of the Federal Employees Health Benefits 

Program and the health benefits program of most large employers so all Americans have affordable health benefit choices. 

Sec. 142. Affordable health choices for all Americans. 


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‘‘TITLE XXXI—AFFORDABLE HEALTH CHOICES FOR ALL 

AMERICANS 

‘‘Subtitle A—Affordable Choices 

‘‘Sec. 3101. Affordable choices of health benefit plans. 

‘‘Sec. 3102. Financial integrity. 

‘‘Sec. 3103. Program design. 

‘‘Sec. 3104. Allowing State flexibility. 

‘‘Sec. 3105. Navigators. 

‘‘Sec. 3106. Community health insurance option. 

‘‘Sec. 3107. Application of same laws to private plans and the community 

health insurance option. 

‘‘Sec. 3108. Participation of professionals on certain health-related commissions. 

‘‘Sec. 3109. Health insurance consumer assistance grants. 

Sec. 143. Freedom not to participate in Federal health insurance programs. 

Subtitle C—Affordable Coverage for All Americans 

Sec. 151. Support for affordable health coverage. 

‘‘Subtitle B—Making Coverage Affordable 

‘‘Sec. 3111. Support for affordable health coverage. 

‘‘Sec. 3112. Small business health options program credit. 

Sec. 152. Program integrity. 

Subtitle D—Shared Responsibility for Health Care 

Sec. 161. Individual responsibility. 

Sec. 162. Notification on the availability of affordable health choices. 

Sec. 163. Shared responsibility of employers. 

‘‘Sec. 3115. Shared responsibility of employers. 

‘‘Sec. 3116. Definitions. 

Subtitle E—Improving Access to Health Care Services 

Sec. 171. Spending for Federally Qualified Health Centers (FQHCs). 

Sec. 172. Other provisions. 

Sec. 173. Negotiated rulemaking for development of methodology and criteria 

for designating medically underserved populations and health 

professions shortage areas. 

Sec. 174. Equity for certain eligible survivors. 

Sec. 175. Reauthorization of the Wakefield Emergency Medical Services for 

Children Program. 

Sec. 176. Co-locating primary and specialty care in community-based mental 

health settings. 

Subtitle F—Making Health Care More Affordable for Retirees 

Sec. 181. Reinsurance for retirees. 

Subtitle G—Improving the Use of Health Information Technology for 

Enrollment; Miscellaneous Provisions 

Sec. 185. Health information technology enrollment standards and protocols. 

Sec. 186. Rule of construction regarding Hawaii’s Prepaid Health Care Act. 


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Sec. 187. Key National indicators. 

Sec. 188. Study and report on rates of preventable diseases in new Medicare 

enrollees. 

Sec. 189. Transparency in government. 

Sec. 189A. Preserving the solvency of Medicare and Social Security. 

Sec. 189B. Prohibition against discrimination on assisted suicide. 

Sec. 189C. Access to therapies. 

Sec. 189D. Freedom not to participate in Federal health insurance programs. 

Subtitle H—CLASS Act 

Sec. 190. Short title of subtitle. 

Sec. 191. Establishment of national voluntary insurance program for purchasing community living assistance services and support. 

‘‘TITLE XXXII—COMMUNITY LIVING ASSISTANCE SERVICES AND 

SUPPORTS 

‘‘Sec. 3201. Purpose. 

‘‘Sec. 3202. Definitions. 

‘‘Sec. 3203. CLASS Independence Benefit Plan. 

‘‘Sec. 3204. Enrollment and disenrollment requirements. 

‘‘Sec. 3205. Benefits. 

‘‘Sec. 3206. CLASS Independence Fund. 

‘‘Sec. 3207. CLASS Independence Advisory Council. 

‘‘Sec. 3208. Regulations; annual report. 

‘‘Sec. 3209. Inspector General’s report. 

‘‘Sec. 3210. Tax treatment of program. 

TITLE II—IMPROVING THE QUALITY AND EFFICIENCY OF 

HEALTH CARE 

Subtitle A—National Strategy to Improve Health Care Quality 

Sec. 201. National strategy. 

Sec. 202. Interagency Working Group on Health Care Quality. 

Sec. 203. Quality measure development. 

Sec. 204. Quality measure endorsement; public reporting; data collection. 

Sec. 205. Collection and analysis of data for quality and resource use measures. 

Subtitle B—Health Care Quality Improvements 

Sec. 211. Health care delivery system research; Quality improvement technical 

assistance. 

Sec. 212. Grants to establish community health teams to support the patientcentered medical home. 

Sec. 213. Grants to implement medication management services in treatment of 

chronic disease. 

Sec. 214. Design and implementation of regionalized systems for emergency 

care. 

Sec. 215. Trauma care centers and service availability. 

Sec. 216. Reducing and reporting hospital readmissions. 

Sec. 217. Program to facilitate shared decisionmaking. 

Sec. 218. Presentation of prescription drug benefit and risk information. 

Sec. 219. Center for health outcomes research and evaluation. 

Sec. 220. Demonstration program to integrate quality improvement and patient 

safety training into clinical education of health professionals. 


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Sec. 221. Office of women’s health. 

Sec. 222. Administrative simplification. 

Sec. 223. Patient navigator program. 

Sec. 224. Authorization of appropriations. 

Subtitle C—Civil and Criminal Penalties for Acts Involving Federal Health 

Care Programs; Exception to Limitation on Certain Physician Referrals 

Sec. 231. Safe harbors to antikickback civil penalties and criminal penalties for 

provision of health information technology and training services. 

Sec. 232. Exception to limitation on certain physician referrals (under Stark) 

for provision of health information technology and training 

services to health care professionals. 

Sec. 233. Rules of construction regarding use of consortia. 

TITLE III—IMPROVING THE HEALTH OF THE AMERICAN PEOPLE 

Subtitle A—Modernizing Disease Prevention and Public Health Systems 

Sec. 301. National Prevention, Health Promotion and Public Health Council. 

Sec. 302. Prevention and Public Health Fund. 

Sec. 303. Clinical and Community Preventive Services. 

Sec. 304. Education and outreach campaign regarding preventive benefits. 

Subtitle B—Increasing Access to Clinical Preventive Services 

Sec. 311. Right choices program. 

Sec. 312. School-based health clinics. 

Sec. 313. Oral healthcare prevention activities. 

Sec. 314. Oral health improvement. 

Subtitle C—Creating Healthier Communities 

Sec. 321. Community transformation grants. 

Sec. 322. Healthy aging, living well. 

Sec. 323. Wellness for individuals with disabilities. 

Sec. 324. Immunizations. 

Sec. 325. Nutrition labeling of standard menu items at chain restaurants and 

of articles of food sold from vending machines. 

Sec. 326. Encouraging employer-sponsored wellness programs. 

Sec. 327. Demonstration project concerning individualized wellness plan. 

Sec. 328. Reasonable break time for nursing mothers. 

Subtitle D—Support for Prevention and Public Health Innovation 

Sec. 331. Research on optimizing the delivery of public health services. 

Sec. 332. Understanding health disparities: data collection and analysis. 

Sec. 333. Health impact assessments. 

Sec. 334. CDC and employer-based wellness programs. 

Sec. 335. Epidemiology-Laboratory Capacity Grants. 

Sec. 336. Federal messaging on health promotion and disease prevention. 

Subtitle E—Advancing Research and Treatment for Pain Care Management 

Sec. 341. Institute of Medicine Conference on Pain. 

Sec. 342. Pain research at National Institutes of Health. 

Sec. 343. Pain care education and training. 


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Sec. 344. Public awareness campaign on pain management. 

Subtitle F—Coordinated Environmental Public Health Network 

Sec. 351. Amendment to the Public Health Service Act. 

Subtitle G—Miscellaneous Provisions 

Sec. 361. Sense of the Senate concerning CBO scoring. 

Sec. 362. Effectiveness of Federal health and wellness initiatives. 

TITLE IV—HEALTH CARE WORKFORCE 

Subtitle A—Purpose and Definitions 

Sec. 401. Purpose. 

Sec. 402. Definitions. 

Subtitle B—Innovations in the Health Care Workforce 

Sec. 411. National health care workforce commission. 

Sec. 412. State health care workforce development grants. 

Sec. 413. Health care workforce program assessment. 

Subtitle C—Increasing the Supply of the Health Care Workforce 

Sec. 421. Federally supported student loan funds. 

Sec. 422. Nursing student loan program. 

Sec. 423. Health care workforce loan repayment programs. 

Sec. 424. Public health workforce recruitment and retention programs. 

Sec. 425. Allied health workforce recruitment and retention programs. 

Sec. 426. Grants for State and local programs. 

Sec. 427. Funding for National Health Service Corps. 

Sec. 428. Nurse-managed health clinics. 

Sec. 429. Elimination of cap on commissioned corps. 

Sec. 430. Establishing a Ready Reserve Corps. 

Subtitle D—Enhancing Health Care Workforce Education and Training 

Sec. 431. Training in family medicine, general internal medicine, general pediatrics, and physician assistantship. 

Sec. 432. Training opportunities for direct care workers. 

Sec. 433. Training in general, pediatric, and public health dentistry. 

Sec. 434. Alternative dental health care providers demonstration project. 

Sec. 435. Geriatric education and training; career awards; comprehensive geriatric education. 

Sec. 436. Mental and behavioral health education and training grants. 

Sec. 437. Cultural competency, prevention and public health and individuals 

with disabilities training. 

Sec. 438. Advanced nursing education grants. 

Sec. 439. Nurse education, practice, and retention grants. 

Sec. 440. Loan repayment and scholarship program. 

Sec. 441. Nurse faculty loan program. 

Sec. 442. Authorization of appropriations for parts B through D of title VIII. 

Sec. 443. Grants to promote the community health workforce. 

Sec. 444. Youth public health program. 

Sec. 445. Fellowship training in public health. 

Sec. 446. United States Public Health Sciences Track. 


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Subtitle E—Supporting the Existing Health Care Workforce 

Sec. 451. Centers of excellence. 

Sec. 452. Health care professionals training for diversity. 

Sec. 453. Interdisciplinary, community-based linkages. 

Sec. 454. Workforce diversity grants. 

Sec. 455. Primary care extension program. 

Sec. 456. Definition of economic hardship. 

Subtitle F—General Provisions 

Sec. 461. Reports. 

TITLE V—PREVENTING FRAUD AND ABUSE 

Subtitle A—Establishment of New Health and Human Services and 

Department of Justice Health Care Fraud Positions 

Sec. 501. Health and Human Services Senior Advisor. 

Sec. 502. Department of Justice Position. 

Sec. 503. Reports to Congress. 

Sec. 504. Fraud, waste, and abuse commission. 

Subtitle B—Health Care Program Integrity Coordinating Council 

Sec. 511. Establishment. 

Subtitle C—False Statements and Representations 

Sec. 521. Prohibition on false statements and representations. 

Subtitle D—Federal Health Care Offense 

Sec. 531. Clarifying definition. 

Subtitle E—Uniformity in Fraud and Abuse Reporting 

Sec. 541. Development of model uniform report form. 

Subtitle F—Applicability of State Law to Combat Fraud and Abuse 

Sec. 551. Applicability of State law to combat fraud and abuse. 

Subtitle G—Enabling the Department of Labor to Issue Administrative Summary Cease and Desist Orders and Summary Seizures Orders Against 

Plans That Are in Financially Hazardous Condition 

Sec. 561. Enabling the Department of Labor to issue administrative summary 

cease and desist orders and summary seizures orders against 

plans that are in financially hazardous condition. 

Subtitle H—Requiring Multiple Employer Welfare Arrangement (MEWA) 

Plans to File a Registration Form With the Department of Labor Prior to 

Enrolling Anyone in the Plan 

Sec. 571. MEWA plan registration with Department of Labor. 

Subtitle I—Permitting Evidentiary Privilege and Confidential Communications 

Sec. 581. Permitting evidentiary privilege and confidential communications. 


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TITLE VI—IMPROVING ACCESS TO INNOVATIVE MEDICAL 

THERAPIES 

Subtitle A—Biologics Price Competition and Innovation 

Sec. 601. Short title. 

Sec. 602. Approval pathway for biosimilar biological products. 

Sec. 603. Savings. 

Subtitle B—More Affordable Medicines for Children and Underserved 

Communities 

Sec. 611. Expanded participation in 340B program. 

Sec. 612. Improvements to 340B program integrity. 

Sec. 613. GAO study to make recommendations on improving the 340B program. 

1 TITLE I—QUALITY, AFFORDABLE 

2 HEALTH CARE FOR ALL 

3 AMERICANS 

4 Subtitle A—Effective Coverage for 

5 All Americans 

6 PART I—PROVISIONS APPLICABLE TO THE 

7 INDIVIDUAL AND GROUP MARKETS 

8 SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

9 ACT. 

10 Part A of title XXVII of the Public Health Service 

11 Act (42 U.S.C. 300gg et seq.) is amended— 

12 (1) by striking the part heading and heading 

13 for subpart 1 and inserting the following: 

14 ‘‘PART A—INDIVIDUAL AND GROUP MARKET 

15 REFORMS 

16 ‘‘Subpart 1—General Reform’’; 

17 (2) in section 2701 (42 U.S.C. 300gg)— 


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1 (A) by striking the section heading and 

2 subsection (a) and inserting the following: 

3 ‘‘SEC. 2705. PROHIBITION OF PREEXISTING CONDITION EX4 CLUSIONS OR OTHER DISCRIMINATION 

5 BASED ON HEALTH STATUS. 

6 ‘‘(a) IN GENERAL.—A group health plan and a health 

7 insurance issuer offering group or individual health insur8 ance coverage may not impose any preexisting condition 

9 exclusion with respect to such plan or coverage.’’; and 

10 (B) by transferring the remainder of sec11 tion so as to appear after the section 2704 as 

12 added by paragraph (5); 

13 (3) in section 2702 (42 U.S.C. 300gg-1)— 

14 (A) by striking the section heading and all 

15 that follows through subsection (a)— 

16 (B) in subsection (b)— 

17 (i) by striking ‘‘health insurance 

18 issuer offering health insurance coverage in 

19 connection with a group health plan’’ each 

20 place that such appears and inserting 

21 ‘‘health insurance issuer offering group or 

22 individual health insurance coverage’’; and 

23 (ii) in paragraph (2)(A)— 

24 (I) by inserting ‘‘or individual’’ 

25 after ‘‘employer’’; and 


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1 (II) by inserting ‘‘or individual 

2 health coverage, as the case may be’’ 

3 before the semicolon; 

4 (C) by redesignating subsections (b) 

5 through (f) as subsections (e) through (i), re6 spectively; and 

7 (D) by transferring the remainder of such 

8 section to appear at the end of section 2706 (as 

9 added by paragraph (5)); 

10 (4) by redesignating existing sections 2704 

11 through 2707 and sections 2711 through 2713 as 

12 sections 2717 through 2720 and sections 2714 

13 through 2716, respectively; and 

14 (5) by inserting after the subpart heading (as 

15 added by paragraph (1)) the following: 

16 ‘‘SEC. 2701. FAIR INSURANCE COVERAGE. 

17 ‘‘(a) IN GENERAL.—With respect to the premium 

18 rate charged by a health insurance issuer for health insur19 ance coverage offered in the individual or small group 

20 market— 

21 ‘‘(1) such rate shall vary with respect to the 

22 particular plan or coverage involved only by— 

23 ‘‘(A) family structure; 

24 ‘‘(B) community rating area; 

25 ‘‘(C) the actuarial value of the benefit; 


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1 ‘‘(D) age, except that such rate shall not 

2 vary by more than 2 to 1; 

3 ‘‘(E) tobacco use, except that such rate 

4 shall not vary by more than 1.5 to 1; and 

5 ‘‘(F) adherence to or participation in a 

6 reasonably designed program of health pro7 motion and disease prevention, if such a pro8 gram is offered by the employer that is the 

9 sponsor of the coverage involved; and 

10 ‘‘(2) such rate shall not vary with respect to the 

11 particular plan or coverage involved by health sta12 tus-related factors, gender, class of business, claims 

13 experience, industry, or any other factor not de14 scribed in paragraph (1), except that group health 

15 plans and health insurance issuers offering group 

16 health insurance coverage may establish premium 

17 discounts or rebates for modifying otherwise applica18 ble copayments or deductibles in return for adher19 ence to or participation in reasonably designed pro20 grams of health promotion or disease prevention. 

21 ‘‘(b) COMMUNITY RATING AREA.—Taking into ac22 count the applicable recommendations of the National As23 sociation of Insurance Commissioners, the Secretary shall 

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1 tained in a Metropolitan Statistical Area, shall not be 

2 smaller than such area. 

3 ‘‘SEC. 2702. GUARANTEED AVAILABILITY OF COVERAGE. 

4 ‘‘(a) ISSUANCE OF COVERAGE IN THE INDIVIDUAL

5 AND GROUP MARKET.—Subject to subsections (b) 

6 through (e), each health insurance issuer that offers 

7 health insurance coverage in the individual or group mar8 ket in a State must accept every employer and individual 

9 in the State that applies for such coverage. 

10 ‘‘(b) ENROLLMENT.— 

11 ‘‘(1) RESTRICTION.—A health insurance issuer 

12 described in subsection (a) may restrict enrollment 

13 in coverage described in such subsection to open or 

14 special enrollment periods. 

15 ‘‘(2) ESTABLISHMENT.—A health insurance 

16 issuer described in subsection (a) shall, in accord17 ance with the regulations promulgated under para18 graph (3), establish special enrollment periods for 

19 qualifying events (under section 603 of the Em20 ployee Retirement Income Security Act of 1974). 

21 ‘‘(3) REGULATIONS.—Not later than 1 year 

22 after the date of enactment of this section, the Sec23 retary shall promulgate regulations with respect to 

24 enrollment periods under paragraphs (1) and (2). 


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1 ‘‘SEC. 2703. GUARANTEED RENEWABILITY OF COVERAGE. 

2 ‘‘(a) IN GENERAL.—Except as provided in this sec3 tion, if a health insurance issuer offers health insurance 

4 coverage in the individual or group market, the issuer 

5 must renew or continue in force such coverage at the op6 tion of the plan sponsor or the individual, as applicable. 

7 ‘‘(b) PROHIBITION ON RESCISSIONS.—A group 

8 health plan and a health insurance issuer offering group 

9 or individual health insurance coverage shall not rescind 

10 such coverage once the plan involved has been issued, ex11 cept that this subsection shall not apply to a covered indi12 vidual who has performed an act or practice that con13 stitutes fraud or makes an intentional misrepresentation 

14 of material fact as prohibited by the terms of the coverage. 

15 Coverage may not be cancelled except with prior notice 

16 to the enrollee, and only as permitted under section 

17 2702(c) or 2742(b). 

18 ‘‘SEC. 2704. INCREASING THE TRANSPARENCY OF HEALTH 

19 CARE COSTS AND REGULATORY FEES. 

20 ‘‘(a) CLEAR ACCOUNTING FOR COSTS.—A health in21 surance issuer offering group or individual health insur22 ance coverage shall publicly report (in a manner to be es23 tablished by the Secretary through regulation) the per24 centage of total premium revenue that such coverage ex25 pends— 


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1 ‘‘(1) on reimbursement for clinical services pro2 vided to enrollees under such plan or coverage; 

3 ‘‘(2) for activities that improve health care 

4 quality; 

5 ‘‘(3) on taxes, license, or regulatory fee costs, 

6 and the cost of any surcharge imposed by the Gate7 way under title XXXI; and 

8 ‘‘(4) on all other non-claims costs, including an 

9 explanation of the nature of such costs and an 

10 itemized list of costs associated with compliance with 

11 the Affordable Health Choices Act. 

12 ‘‘(b) DEFINITION.—In this section, the term ‘activi13 ties to improve health care quality’ means activities de14 scribed in section 2707. 

15 ‘‘(c) PROCESSES AND METHODS.—The Secretary 

16 shall develop a methodology for calculating the percent17 ages described in subsection (a). Such methodology may 

18 provide for a requirement that a report described in sub19 section (a) include an actuarial certification of the infor20 mation included in such report. 

21 ‘‘SEC. 2706. PROHIBITING DISCRIMINATION AGAINST INDI22 VIDUAL PARTICIPANTS AND BENEFICIARIES 

23 BASED ON HEALTH STATUS. 

24 ‘‘(a) IN GENERAL.—A group health plan and a health 

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1 ance coverage may not establish rules for eligibility (in2 cluding continued eligibility) of any individual to enroll 

3 under the terms of the plan or coverage based on any of 

4 the following health status-related factors in relation to 

5 the individual or a dependent of the individual: 

6 ‘‘(1) Health status. 

7 ‘‘(2) Medical condition (including both physical 

8 and mental illnesses). 

9 ‘‘(3) Claims experience. 

10 ‘‘(4) Receipt of health care. 

11 ‘‘(5) Medical history. 

12 ‘‘(6) Genetic information. 

13 ‘‘(7) Evidence of insurability (including condi14 tions arising out of acts of domestic violence). 

15 ‘‘(8) Disability. 

16 ‘‘(9) Any other health status-related factor de17 termined appropriate by the Secretary. 

18 ‘‘(b) PROGRAMS OF HEALTH PROMOTION OR DIS19 EASE PREVENTION.— 

20 ‘‘(1) GENERAL PROVISIONS.— 

21 ‘‘(A) GENERAL RULE.—For purposes of 

22 paragraph (2)(B), a program of health pro23 motion or disease prevention (referred to in this 

24 subsection as a ‘wellness program’) shall be a 

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1 signed to promote health or prevent disease 

2 that meets the applicable requirements of this 

3 subsection. 

4 ‘‘(B) NO CONDITIONS BASED ON HEALTH

5 STATUS FACTOR.—If none of the conditions for 

6 obtaining a premium discount or rebate or 

7 other reward for participation in a wellness pro8 gram is based on an individual satisfying a 

9 standard that is related to a health status fac10 tor, such wellness program shall not violate this 

11 section if participation in the program is made 

12 available to all similarly situated individuals 

13 and the requirements of paragraph (2) are com14 plied with. 

15 ‘‘(C) CONDITIONS BASED ON HEALTH STA16 TUS FACTOR.—If any of the conditions for ob17 taining a premium discount or rebate or other 

18 reward for participation in a wellness program 

19 is based on an individual satisfying a standard 

20 that is related to a health status factor, such 

21 wellness program shall not violate this section if 

22 the requirements of paragraph (3) are complied 

23 with. 

24 ‘‘(2) WELLNESS PROGRAMS NOT SUBJECT TO

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1 taining a premium discount or rebate or other re2 ward under a wellness program as described in para3 graph (1)(B) are based on an individual satisfying 

4 a standard that is related to a health status factor 

5 (or if such a wellness program does not provide such 

6 a reward), the wellness program shall not violate 

7 this section if participation in the program is made 

8 available to all similarly situated individuals. The 

9 following programs shall not have to comply with the 

10 requirements of paragraph (3) if participation in the 

11 program is made available to all similarly situated 

12 individuals: 

13 ‘‘(A) A program that reimburses all or 

14 part of the cost for memberships in a fitness 

15 center. 

16 ‘‘(B) A diagnostic testing program that 

17 provides a reward for participation and does 

18 not base any part of the reward on outcomes. 

19 ‘‘(C) A program that encourages preven20 tive care related to a health condition through 

21 the waiver of the copayment or deductible re22 quirement under an individual or group health 

23 plan for the costs of certain items or services 

24 related to a health condition (such as prenatal 

25 care or well-baby visits). 


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1 ‘‘(D) A program that reimburses individ2 uals for the costs of smoking cessation pro3 grams without regard to whether the individual 

4 quits smoking. 

5 ‘‘(E) A program that provides a reward to 

6 individuals for attending a periodic health edu7 cation seminar. 

8 ‘‘(3) WELLNESS PROGRAMS SUBJECT TO RE9 QUIREMENTS.—If any of the conditions for obtaining 

10 a premium discount, rebate, or reward under a 

11 wellness program as described in paragraph (1)(C) 

12 is based on an individual satisfying a standard that 

13 is related to a health status factor, the wellness pro14 gram shall not violate this section if the following re15 quirements are complied with: 

16 ‘‘(A) The reward for the wellness program, 

17 together with the reward for other wellness pro18 grams with respect to the plan that requires 

19 satisfaction of a standard related to a health 

20 status factor, shall not exceed 30 percent of the 

21 cost of employee-only coverage under the plan. 

22 If, in addition to employees or individuals, any 

23 class of dependents (such as spouses or spouses 

24 and dependent children) may participate fully 

25 in the wellness program, such reward shall not 


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1 exceed 30 percent of the cost of the coverage in 

2 which an employee or individual and any de3 pendents are enrolled. For purposes of this 

4 paragraph, the cost of coverage shall be deter5 mined based on the total amount of employer 

6 and employee contributions for the benefit 

7 package under which the employee is (or the 

8 employee and any dependents are) receiving 

9 coverage. A reward may be in the form of a dis10 count or rebate of a premium or contribution, 

11 a waiver of all or part of a cost-sharing mecha12 nism (such as deductibles, copayments, or coin13 surance), the absence of a surcharge, or the 

14 value of a benefit that would otherwise not be 

15 provided under the plan. The Secretaries of 

16 Labor, Health and Human Services, and the 

17 Treasury may increase the reward available 

18 under this subparagraph to up to 50 percent of 

19 the cost of coverage if the Secretaries determine 

20 that such an increase is appropriate. 

21 ‘‘(B) The wellness program shall be rea22 sonably designed to promote health or prevent 

23 disease. A program complies with the preceding 

24 sentence if the program has a reasonable 

25 chance of improving the health of, or preventing 


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1 disease in, participating individuals and it is 

2 not overly burdensome, is not a subterfuge for 

3 discriminating based on a health status factor, 

4 and is not highly suspect in the method chosen 

5 to promote health or prevent disease. The plan 

6 or issuer shall evaluate the program’s reason7 ableness at least once per year. 

8 ‘‘(C) The plan shall give individuals eligible 

9 for the program the opportunity to qualify for 

10 the reward under the program at least once 

11 each year. 

12 ‘‘(D) The full reward under the wellness 

13 program shall be made available to all similarly 

14 situated individuals. For such purpose, among 

15 other things: 

16 ‘‘(i) The reward is not available to all 

17 similarly situated individuals for a period 

18 unless the wellness program allows— 

19 ‘‘(I) for a reasonable alternative 

20 standard (or waiver of the otherwise 

21 applicable standard) for obtaining the 

22 reward for any individual for whom, 

23 for that period, it is unreasonably dif24 ficult due to a medical condition to 


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1 satisfy the otherwise applicable stand2 ard; and 

3 ‘‘(II) for a reasonable alternative 

4 standard (or waiver of the otherwise 

5 applicable standard) for obtaining the 

6 reward for any individual for whom, 

7 for that period, it is medically inadvis8 able to attempt to satisfy the other9 wise applicable standard. 

10 ‘‘(ii) If reasonable under the cir11 cumstances, the plan or issuer may seek 

12 verification, such as a statement from an 

13 individual’s physician, that a health status 

14 factor makes it unreasonably difficult or 

15 medically inadvisable for the individual to 

16 satisfy or attempt to satisfy the otherwise 

17 applicable standard. 

18 ‘‘(E) The plan or issuer involved shall dis19 close in all plan materials describing the terms 

20 of the wellness program the availability of a 

21 reasonable alternative standard (or the possi22 bility of waiver of the otherwise applicable 

23 standard) required under subparagraph (D). If 

24 plan materials disclose that such a program is 

25 available, without describing its terms, the disVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 closure under this subparagraph shall not be re2 quired. 

3 ‘‘(c) EXISTING PROGRAMS.—Nothing in this section 

4 shall prohibit a program of health promotion or disease 

5 prevention that was established prior to the date of enact6 ment of this section and applied with all applicable regula7 tions, and that is operating on such date, from continuing 

8 to be carried out for as long as such regulations remain 

9 in effect. 

10 ‘‘(d) REGULATIONS.—Nothing in this section shall be 

11 construed as prohibiting the Secretaries of Labor, Health 

12 and Human Services, or the Treasury from promulgating 

13 regulations in connection with this section. 

14 ‘‘SEC. 2707. ENSURING THE QUALITY OF CARE. 

15 ‘‘(a) IN GENERAL.—Except as provided in subsection 

16 (c), a group health plan and a health insurance issuer of17 fering group or individual health insurance coverage shall 

18 develop and implement a reimbursement structure for 

19 making payments to health care providers that provides 

20 incentives for— 

21 ‘‘(1) the provision of high quality health care 

22 under the plan or coverage in a manner that in23 cludes— 

24 ‘‘(A) the implementation of case manage25 ment, care coordination, chronic disease manVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 agement, and medication and care compliance 

2 activities that includes the use of the medical 

3 home model as defined in section 212 of the Af4 fordable Health Choices Act for treatment or 

5 services under the plan or coverage; 

6 ‘‘(B) the implementation of activities to 

7 prevent hospital readmissions through a com8 prehensive program for hospital discharge that 

9 includes patient-centered education and coun10 seling, comprehensive discharge planning, and 

11 post-discharge reinforcement by an appropriate 

12 health care professional; 

13 ‘‘(C) the implementation of activities to 

14 improve patient safety and reduce medical er15 rors through the appropriate use of best clinical 

16 practices, evidence based medicine, and health 

17 information technology under the plan or cov18 erage; 

19 ‘‘(D) the implementation of wellness and 

20 health promotion activities; 

21 ‘‘(E) child health measures under section 

22 1139A of the Social Security Act; and 

23 ‘‘(F) culturally and linguistically appro24 priate care, as defined by the Secretary; and 


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1 ‘‘(2) payment policies that substantially reflects 

2 the payment policy of the Medicare program under 

3 title XVIII of the Social Security Act and the Chil4 dren’s Health Insurance Program under title XXI of 

5 such Act with respect to any generally implemented 

6 incentive policy to promote high quality health care, 

7 except that in order that no plan or issuer be forced 

8 to deny patients medical care needed to prevent 

9 their deaths or preserve or restore their health, no 

10 plan or issuer shall be prohibited from providing 

11 payment for a treatment or diagnostic procedure it 

12 chooses to cover, unless such treatment or procedure 

13 has been determined to be unsafe or dangerous or 

14 capable of neither preventing the patient’s death nor 

15 preserving or restoring the patient’s health. 

16 ‘‘(b) WELLNESS AND PREVENTION PROGRAMS.—For 

17 purposes of subsection (a)(1)(D), wellness and health pro18 motion activities may include personalized wellness and 

19 prevention services, which are coordinated, maintained or 

20 delivered by a health care provider, a wellness and preven21 tion plan manager, or a health, wellness or prevention 

22 services organization that conducts health risk assess23 ments or offer ongoing face-to-face, telephonic or web24 based intervention efforts for each of the program’s parVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 ticipants, and which may include the following wellness 

2 and prevention efforts: 

3 ‘‘(1) Smoking cessation. 

4 ‘‘(2) Weight management. 

5 ‘‘(3) Stress management. 

6 ‘‘(4) Physical fitness. 

7 ‘‘(5) Nutrition. 

8 ‘‘(6) Heart disease prevention. 

9 ‘‘(7) Healthy lifestyle support. 

10 ‘‘(8) Diabetes prevention. 

11 ‘‘(c) EXCEPTIONS.—In promulgating regulations 

12 under subsection (d), the Secretary may provide for excep13 tions to the requirements of subsection (a) for insurers 

14 that substantially meet the goals of this section. 

15 ‘‘(d) REGULATIONS.—Not later than 180 days after 

16 the date of enactment of the Affordable Health Choices 

17 Act, the Secretary shall promulgate regulations— 

18 ‘‘(1) that define the term ‘generally imple19 mented’ for purposes of subsection (a)(2); 

20 ‘‘(2) that require the expiration of a minimum 

21 period of time between the date on which a policy 

22 is generally implemented for purposes of subsection 

23 (a)(2) and the date on which such policy shall apply 

24 with respect to health insurance coverage offered in 

25 the individual or group market; and 


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1 ‘‘(3) that provide criteria for determining 

2 whether a payment policy is described in subsection 

3 (a). 

4 ‘‘(e) STUDY AND REPORT.—Not later than 180 days 

5 after the date of enactment of the Affordable Health 

6 Choices Act, the Government Accountability Office shall 

7 conduct a study and submit to the Committee on Health, 

8 Education, Labor, and Pensions of the Senate and the 

9 Committee on Energy and Commerce of the House of 

10 Representatives a report regarding the impact the activi11 ties under this section have had on the quality and cost 

12 of health care. 

13 ‘‘SEC. 2708. COVERAGE OF PREVENTIVE HEALTH SERVICES. 

14 ‘‘(a) IN GENERAL.—A group health plan and a health 

15 insurance issuer offering group or individual health insur16 ance coverage shall provide coverage for and shall not im17 pose any cost sharing requirements (other than minimal 

18 cost sharing in accordance with guidelines developed by 

19 the Secretary) for— 

20 ‘‘(1) evidence-based items or services that have 

21 in effect a rating of ‘A’ or ‘B’ in the current rec22 ommendations of the United States Preventive Serv23 ices Task Force; 

24 ‘‘(2) immunizations that have in effect a rec25 ommendation from the Advisory Committee on ImVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 munization Practices of the Centers for Disease 

2 Control and Prevention with respect to the indi3 vidual involved; and 

4 ‘‘(3) with respect to infants, children, and ado5 lescents, evidence-informed preventive care and 

6 screenings provided for in the comprehensive guide7 lines supported by the Health Resources and Serv8 ices Administration. 

9 ‘‘(b) INTERVAL.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall estab11 lish a minimum interval between the date on which 

12 a recommendation described in subsection (a)(1) or 

13 (a)(2) or a guideline under subsection (a)(3) is 

14 issued and the plan year with respect to which the 

15 requirement described in subsection (a) is effective 

16 with respect to the service described in such rec17 ommendation or guideline. 

18 ‘‘(2) MINIMUM.—The interval described in 

19 paragraph (1) shall not be less than 1 year. 

20 ‘‘SEC. 2709. COVERAGE OF PREVENTIVE WOMEN’S HEALTH 

21 SERVICES. 

22 ‘‘A group health plan and a health insurance issuer 

23 offering group or individual health insurance coverage 

24 shall provide coverage for, and shall not impose any cost 

25 sharing requirements (other than minimal cost sharing in 


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1 accordance with guidelines developed by the Secretary) 

2 for, with respect to women (including pregnant women 

3 and individuals of child bearing age), such additional pre4 ventive care and screenings not covered under section 

5 2708 as provided for in guidelines supported by the 

6 Health Resources and Services Administration. 

7 ‘‘SEC. 2710. EXTENSION OF DEPENDENT COVERAGE. 

8 ‘‘(a) IN GENERAL.—A group health plan and a health 

9 insurance issuer offering group or individual health insur10 ance coverage that provides dependent coverage of chil11 dren shall continue to make such coverage available for 

12 an adult child until the child turns 26 years of age. Noth13 ing in this section shall require a health plan or a health 

14 insurance issuer described in the preceding sentence to 

15 make coverage available for a child of a child receiving 

16 dependent coverage. 

17 ‘‘(b) REGULATIONS.—The Secretary shall promul18 gate regulations to define the dependents to which cov19 erage shall be made available under subsection (a). 

20 ‘‘SEC. 2711. NO LIFETIME OR ANNUAL LIMITS. 

21 ‘‘(a) IN GENERAL.—A group health plan and a health 

22 insurance issuer offering group or individual health insur23 ance coverage may not establish lifetime or annual limits 

24 on the dollar value of benefits for any participant or bene25 ficiary. 


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1 ‘‘(b) PREVENTING FRAUD AND ABUSE.—This section 

2 shall not apply until the date on which the Secretary cer3 tifies that enacting this section will not result in undue 

4 proliferation of fraud and abuse, especially with regard to 

5 durable medical equipment. 

6 ‘‘SEC. 2712. NOTIFICATION BY PLANS NOT PROVIDING MIN7 IMUM QUALIFYING COVERAGE. 

8 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

9 date on which the Secretary establishes criteria with re10 spect to minimum qualifying coverage under section 3103, 

11 a group health plan and a health insurance issuer offering 

12 group or individual health insurance coverage that fails 

13 to provide such minimum qualifying coverage shall notify, 

14 in such manner as may be required by the Secretary, en15 rollees and prospective enrollees in such plan or coverage 

16 of such failure prior to enrollment or re-enrollment. 

17 ‘‘(b) MODIFICATIONS.—If the Secretary modifies the 

18 criteria with respect to minimum qualifying coverage 

19 under section 3103, a group health plan or health insur20 ance issuer that fails to provide such modified minimum 

21 qualifying coverage shall provide the notice required under 

22 subsection (a) within 60 days of the date of such modifica23 tion. 


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1 ‘‘SEC. 2713. NON-DISCRIMINATION IN HEALTH CARE. 

2 ‘‘A group health plan and a health insurance issuer 

3 offering group or individual health insurance coverage 

4 shall not discriminate with respect to participation under 

5 the plan or coverage against any health care provider who 

6 is acting within the scope of that provider’s license or cer7 tification under applicable State law. This section shall not 

8 require that a group health plan or health insurance issuer 

9 contract with any health care provider willing to abide by 

10 the terms and conditions for participation established by 

11 the plan or issuer. Nothing in this section shall be con12 strued as preventing a group health plan, a health insur13 ance issuer, or the Secretary from establishing varying re14 imbursement rates based on quality or performance meas15 ures.’’. 

16 PART II—PROVISION APPLICABLE TO THE 

17 GROUP MARKET 

18 SEC. 121. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

19 ACT. 

20 Subpart 2 of part A of title XXVII of the Public 

21 Health Service Act (42 U.S.C. 300gg-4 et seq.) is amend22 ed by adding at the end the following: 

23 ‘‘SEC. 2720A. PROHIBITION OF DISCRIMINATION BASED ON 

24 SALARY. 

25 ‘‘(a) IN GENERAL.—A group health plan and a health 

26 insurance issuer offering group health insurance coverage 


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1 may not establish rules relating to the health insurance 

2 coverage eligibility (including continued eligibility) of any 

3 full-time employee under the terms of the plan that are 

4 based on the total hourly or annual salary of the employee. 

5 ‘‘(b) LIMITATION.—Subsection (a) shall not be con6 strued to prohibit a group health plan or health insurance 

7 issuer from establishing contribution requirements for en8 rollment in the plan or coverage that provide for the pay9 ment by employees with lower hourly or annual compensa10 tion of a lower dollar or percentage contribution than the 

11 payment required of a similarly situated employees with 

12 a higher hourly or annual compensation.’’. 

13 PART III—OTHER PROVISIONS 

14 SEC. 131. NO CHANGES TO EXISTING COVERAGE. 

15 (a) OPTION TO RETAIN CURRENT INSURANCE COV16 ERAGE.— 

17 (1) IN GENERAL.—Nothing in this Act (or an 

18 amendment made by this Act) shall be construed to 

19 require that an individual terminate coverage under 

20 a group health plan or health insurance coverage in 

21 which such individual was enrolled prior to the date 

22 of enactment of this title. 

23 (2) CONTINUATION OF COVERAGE.—With re24 spect to a group health plan or health insurance cov25 erage in which an individual was enrolled prior to 


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1 the date of enactment of this title, this subtitle (and 

2 the amendments made by this subtitle) shall not 

3 apply to such plan or coverage, regardless of wheth4 er the individual renews such coverage after such 

5 date of enactment. 

6 (b) ALLOWANCE FOR FAMILY MEMBERS TO JOIN

7 CURRENT COVERAGE.—With respect to a group health 

8 plan or health insurance coverage in which an individual 

9 was enrolled prior to the date of enactment of this title 

10 and which is renewed after such date, family members of 

11 such individual shall be permitted to enroll in such plan 

12 or coverage if such enrollment is permitted under the 

13 terms of the plan in effect as of such date of enactment. 

14 (c) ALLOWANCE FOR NEW EMPLOYEES TO JOIN

15 CURRENT PLAN.—A group health plan that provides cov16 erage on the date of enactment of this Act may provide 

17 for the enrolling of new employees (and their families) in 

18 such plan, and this subtitle (and the amendments made 

19 by this subtitle) shall not apply with respect to such plan 

20 and such new employees (and their families). 

21 (d) NO ADDITIONAL BENEFIT.—Subsections (b) and 

22 (c) shall only apply to individuals described in such sub23 sections and the family members of such individuals (as 

24 provided for in such subsections). 


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1 (e) LIMITATION.—Subsections (a) through (d) shall 

2 not apply to any group health plan or health insurance 

3 coverage that has been modified to a significant extent 

4 with respect to covered benefits or cost sharing require5 ments after the date of enactment of this Act. The Sec6 retary shall by regulation establish criteria to determine 

7 whether a plan or health insurance coverage has been 

8 modified to a significant extent under the preceding sen9 tence, except that any coverage amendment made pursu10 ant to an agreement between an employer or an individual 

11 and a health insurance issuer relating to the coverage 

12 which amends the coverage solely to conform to any re13 quirement added by this Act (or amendments to this Act) 

14 shall not be treated as a significant modification. 

15 (f) EFFECT ON COLLECTIVE BARGAINING AGREE16 MENTS.—In the case of health insurance coverage main17 tained pursuant to one or more collective bargaining 

18 agreements between employee representatives and one or 

19 more employers that was ratified before the date of enact20 ment of this title, the provisions of this subtitle (and the 

21 amendments made by this subtitle) shall not apply until 

22 the date on which the last of the collective bargaining 

23 agreements relating to the coverage terminates. Any cov24 erage amendment made pursuant to a collective bar25 gaining agreement relating to the coverage which amends 


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1 the coverage solely to conform to any requirement added 

2 by this subtitle (or amendments) shall not be treated as 

3 a termination of such collective bargaining agreement. 

4 (g) RISK ADJUSTMENT.—The provisions of section 

5 3101(c)(6) of the Public Health Service Act (as added by 

6 section 142) shall not apply to a group health plan or 

7 health insurance coverage to which this section applies. 

8 SEC. 132. APPLICABILITY. 

9 Section 2721 of the Public Health Service Act (42 

10 U.S.C. 300gg-21) is amended— 

11 (1) by striking subsection (a); 

12 (2) in subsection (b)— 

13 (A) in paragraph (1), by striking ‘‘1 

14 through 3’’ and inserting ‘‘1 and 2’’; and 

15 (B) in paragraph (2)— 

16 (i) in subparagraph (A), by striking 

17 ‘‘subparagraph (D)’’ and inserting ‘‘sub18 paragraph (D) or (E)’’; 

19 (ii) by striking ‘‘1 through 3’’ and in20 serting ‘‘1 and 2’’; and 

21 (iii) by adding at the end the fol22 lowing: 

23 ‘‘(E) ELECTION NOT APPLICABLE.—The 

24 election described in subparagraph (A) shall not 


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1 be available with respect to the provisions of 

2 subpart 1.’’; 

3 (3) in subsection (c), by striking ‘‘1 through 3 

4 shall not apply to any group’’ and inserting ‘‘1 and 

5 2 shall not apply to any individual coverage or any 

6 group’’; and 

7 (4) in subsection (d)— 

8 (A) in paragraph (1), by striking ‘‘1 

9 through 3 shall not apply to any group’’ and in10 serting ‘‘1 and 2 shall not apply to any indi11 vidual coverage or any group’’; 

12 (B) in paragraph (2)— 

13 (i) in the matter preceding subpara14 graph (A), by striking ‘‘1 through 3 shall 

15 not apply to any group’’ and inserting ‘‘1 

16 and 2 shall not apply to any individual cov17 erage or any group’’; and 

18 (ii) in subparagraph (C), by inserting 

19 ‘‘or, with respect to individual coverage, 

20 under any health insurance coverage main21 tained by the same health insurance 

22 issuer’’; and 

23 (C) in paragraph (3), by striking ‘‘any 

24 group’’ and inserting ‘‘any individual coverage 

25 or any group’’. 


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1 SEC. 133. CONFORMING AMENDMENTS. 

2 (a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of 

3 the Public Health Service Act (42 U.S.C. 300gg et seq.) 

4 is amended— 

5 (1) in section 2705 (42 U.S.C. 300gg), as so 

6 redesignated by section 101(2)— 

7 (A) in subsection (c)— 

8 (i) in paragraph (2), by striking 

9 ‘‘group health plan’’ each place that such 

10 appears and inserting ‘‘group or individual 

11 health plan’’; and 

12 (ii) in paragraph (3)— 

13 (I) by striking ‘‘group health in14 surance’’ each place that such appears 

15 and inserting ‘‘group or individual 

16 health insurance’’; and 

17 (II) in subparagraph (D), by 

18 striking ‘‘small or large’’ and insert19 ing ‘‘individual or group’’; 

20 (B) in subsection (d), by striking ‘‘group 

21 health insurance’’ each place that such appears 

22 and inserting ‘‘group or individual health insur23 ance’’; and 

24 (C) in subsection (e)(1)(A), by striking 

25 ‘‘group health insurance’’ and inserting ‘‘group 

26 or individual health insurance’’; 


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1 (2) by striking the heading for subpart 2 of 

2 part A; 

3 (3) in section 2717 (42 U.S.C. 300gg-4), as so 

4 redesignated— 

5 (A) in subsection (a), by striking ‘‘health 

6 insurance issuer offering group health insur7 ance coverage’’ and inserting ‘‘health insurance 

8 issuer offering group or individual health insur9 ance coverage’’; 

10 (B) in subsection (b)— 

11 (i) by striking ‘‘health insurance 

12 issuer offering group health insurance cov13 erage in connection with a group health 

14 plan’’ in the matter preceding paragraph 

15 (1) and inserting ‘‘health insurance issuer 

16 offering group or individual health insur17 ance coverage’’; and 

18 (ii) in paragraph (1), by striking 

19 ‘‘plan’’ and inserting ‘‘plan or coverage’’; 

20 (C) in subsection (c)— 

21 (i) in paragraph (2), by striking 

22 ‘‘group health insurance coverage offered 

23 by a health insurance issuer’’ and inserting 

24 ‘‘health insurance issuer offering group or 

25 individual health insurance coverage’’; and 


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1 (ii) in paragraph (3), by striking 

2 ‘‘issuer’’ and inserting ‘‘health insurance 

3 issuer’’; and 

4 (D) in subsection (e), by striking ‘‘health 

5 insurance issuer offering group health insur6 ance coverage’’ and inserting ‘‘health insurance 

7 issuer offering group or individual health insur8 ance coverage’’; 

9 (4) in section 2718 (42 U.S.C. 300gg-5), as so 

10 redesignated— 

11 (A) in subsection (a), by striking ‘‘(or 

12 health insurance coverage offered in connection 

13 with such a plan)’’ each place that such appears 

14 and inserting ‘‘or a health insurance issuer of15 fering group or individual health insurance cov16 erage’’; 

17 (B) in subsection (b), by striking ‘‘(or 

18 health insurance coverage offered in connection 

19 with such a plan)’’ each place that such appears 

20 and inserting ‘‘or a health insurance issuer of21 fering group or individual health insurance cov22 erage’’; and 

23 (C) in subsection (c)— 

24 (i) in paragraph (1), by striking ‘‘(and 

25 group health insurance coverage offered in 


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1 connection with a group health plan)’’ and 

2 inserting ‘‘and a health insurance issuer 

3 offering group or individual health insur4 ance coverage’’; 

5 (ii) in paragraph (2), by striking ‘‘(or 

6 health insurance coverage offered in con7 nection with such a plan)’’ each place that 

8 such appears and inserting ‘‘or a health in9 surance issuer offering group or individual 

10 health insurance coverage’’; 

11 (5) in section 2719 (42 U.S.C. 300gg-6), as so 

12 redesignated, by striking ‘‘health insurance issuers 

13 providing health insurance coverage in connection 

14 with group health plans’’ and inserting ‘‘and health 

15 insurance issuers offering group or individual health 

16 insurance coverage’’; 

17 (6) in section 2720 (42 U.S.C. 300gg-7), as so 

18 redesignated— 

19 (A) in subsection (a), by striking ‘‘health 

20 insurance coverage offered in connection with 

21 such plan’’ and inserting ‘‘individual health in22 surance coverage’’; 

23 (B) in subsection (b)— 

24 (i) in paragraph (1), by striking ‘‘or a 

25 health insurance issuer that provides 


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1 health insurance coverage in connection 

2 with a group health plan’’ and inserting 

3 ‘‘or a health insurance issuer that offers 

4 group or individual health insurance cov5 erage’’; 

6 (ii) in paragraph (2), by striking 

7 ‘‘health insurance coverage offered in con8 nection with the plan’’ and inserting ‘‘indi9 vidual health insurance coverage’’; and 

10 (iii) in paragraph (3), by striking 

11 ‘‘health insurance coverage offered by an 

12 issuer in connection with such plan’’ and 

13 inserting ‘‘individual health insurance cov14 erage’’; 

15 (C) in subsection (c), by striking ‘‘health 

16 insurance issuer providing health insurance cov17 erage in connection with a group health plan’’ 

18 and inserting ‘‘health insurance issuer that of19 fers group or individual health insurance cov20 erage’’; and 

21 (D) in subsection (e)(1), by striking 

22 ‘‘health insurance coverage offered in connec23 tion with such a plan’’ and inserting ‘‘individual 

24 health insurance coverage’’; 

25 (7) by striking the heading for subpart 3; 


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1 (8) in section 2714 (42 U.S.C. 300gg-11), as so 

2 redesignated— 

3 (A) by striking the section heading and all 

4 that follows through subsection (b); 

5 (B) in subsection (c)— 

6 (i) in paragraph (1)— 

7 (I) in the matter preceding sub8 paragraph (A), by striking ‘‘small 

9 group’’ and inserting ‘‘group and indi10 vidual’’; and 

11 (II) in subparagraph (B)— 

12 (aa) in the matter preceding 

13 clause (i), by inserting ‘‘and indi14 viduals’’ after ‘‘employers’’; 

15 (bb) in clause (i), by insert16 ing ‘‘or any additional individ17 uals’’ after ‘‘additional groups’’; 

18 and 

19 (cc) in clause (ii), by strik20 ing ‘‘without regard to the claims 

21 experience of those employers 

22 and their employees (and their 

23 dependents) or any health status24 related factor relating to such’’ 

25 and inserting ‘‘and individuals 


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1 without regard to the claims ex2 perience of those individuals, em3 ployers and their employees (and 

4 their dependents) or any health 

5 status-related factor relating to 

6 such individuals’’; and 

7 (ii) in paragraph (2), by striking 

8 ‘‘small group’’ and inserting ‘‘group or in9 dividual’’; 

10 (C) in subsection (d)— 

11 (i) by striking ‘‘small group’’ each 

12 place that such appears and inserting 

13 ‘‘group or individual’’; and 

14 (ii) in paragraph (1)(B)— 

15 (I) by striking ‘‘all employers’’ 

16 and inserting ‘‘all employers and indi17 viduals’’; 

18 (II) by striking ‘‘those employ19 ers’’ and inserting ‘‘those individuals, 

20 employers’’; and 

21 (III) by striking ‘‘such employ22 ees’’ and inserting ‘‘such individuals, 

23 employees’’; 

24 (D) by striking subsection (e); 

25 (E) by striking subsection (f); and 


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1 (F) by transferring the remainder of such 

2 section to appear at the end of section 2702 (as 

3 added by section 101(5)); 

4 (9) in section 2715 (42 U.S.C. 300gg-12), as so 

5 redesignated— 

6 (A) by striking the section heading and all 

7 that follows through subsection (a); 

8 (B) in subsection (b)— 

9 (i) in the matter preceding paragraph 

10 (1), by striking ‘‘group health plan in the 

11 small or large group market’’ and inserting 

12 ‘‘health insurance coverage offered in the 

13 group or individual market’’; 

14 (ii) in paragraph (1), by inserting ‘‘, 

15 or individual, as applicable,’’ after ‘‘plan 

16 sponsor’’; 

17 (iii) in paragraph (2), by inserting ‘‘, 

18 or individual, as applicable,’’ after ‘‘plan 

19 sponsor’’; and 

20 (iv) by striking paragraph (3) and in21 serting the following: 

22 ‘‘(3) VIOLATION OF PARTICIPATION OR CON23 TRIBUTION RATES.—In the case of a group health 

24 plan, the plan sponsor has failed to comply with a 

25 material plan provision relating to employer conVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 tribution or group participation rules, pursuant to 

2 applicable State law.’’; 

3 (C) in subsection (c)— 

4 (i) in paragraph (1)— 

5 (I) in the matter preceding sub6 paragraph (A), by striking ‘‘group 

7 health insurance coverage offered in 

8 the small or large group market’’ and 

9 inserting ‘‘group or individual health 

10 insurance coverage’’; 

11 (II) in subparagraph (A), by in12 serting ‘‘or individual, as applicable,’’ 

13 after ‘‘plan sponsor’’; 

14 (III) in subparagraph (B)— 

15 (aa) by inserting ‘‘or indi16 vidual, as applicable,’’ after ‘‘plan 

17 sponsor’’; and 

18 (bb) by inserting ‘‘or indi19 vidual health insurance cov20 erage’’; and 

21 (IV) in subparagraph (C), by in22 serting ‘‘or individuals, as applicable,’’ 

23 after ‘‘those sponsors’’; and 

24 (ii) in paragraph (2)(A)— 


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1 (I) in the matter preceding clause 

2 (i), by striking ‘‘small group market 

3 or the large group market, or both 

4 markets,’’ and inserting ‘‘individual or 

5 group market, or all markets,’’; and 

6 (II) in clause (i), by inserting ‘‘or 

7 individual, as applicable,’’ after ‘‘plan 

8 sponsor’’; and 

9 (D) by transferring the remainder of such 

10 section to appear at the end of section 2703 (as 

11 added by section 101(5)); 

12 (10) in section 2716 (42 U.S.C. 300gg-13), as 

13 so redesignated— 

14 (A) in subsection (a)— 

15 (i) in the matter preceding paragraph 

16 (1), by striking ‘‘small employer’’ and in17 serting ‘‘small employer or an individual’’; 

18 (ii) in paragraph (1), by inserting ‘‘, 

19 or individual, as applicable,’’ after ‘‘em20 ployer’’ each place that such appears; and 

21 (iii) in paragraph (2), by striking 

22 ‘‘small employer’’ and inserting ‘‘employer, 

23 or individual, as applicable,’’; 

24 (B) in subsection (b)— 

25 (i) in paragraph (1)— 


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1 (I) in the matter preceding sub2 paragraph (A), by striking ‘‘small em3 ployer’’ and inserting ‘‘employer, or 

4 individual, as applicable,’’; 

5 (II) in subparagraph (A), by add6 ing ‘‘and’’ at the end; 

7 (III) by striking subparagraphs 

8 (B) and (C); and 

9 (IV) in subparagraph (D)— 

10 (aa) by inserting ‘‘, or indi11 vidual, as applicable,’’ after ‘‘em12 ployer’’; and 

13 (bb) by redesignating such 

14 subparagraph as subparagraph 

15 (B); 

16 (ii) in paragraph (2)— 

17 (I) by striking ‘‘small employers’’ 

18 each place that such appears and in19 serting ‘‘employers, or individuals, as 

20 applicable,’’; and 

21 (II) by striking ‘‘small employer’’ 

22 and inserting ‘‘employer, or indi23 vidual, as applicable,’’; and 

24 (C) by redesignating such section as sec25 tion 2712 and transferring such section to apVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 pear after section 2711 (as added by section 

2 101(5)); 

3 (11) by redesignating subpart 4 as subpart 2; 

4 (12) in section 2721 (42 U.S.C. 300gg-21)— 

5 (A) by striking subsection (a); 

6 (B) by striking ‘‘subparts 1 through 3’’ 

7 each place that such appears and inserting 

8 ‘‘subpart 1’’; and 

9 (C) by redesignating subsections (b) 

10 through (e) as subsections (a) through (d), re11 spectively; 

12 (13) in section 2722 (42 U.S.C. 300gg-22)— 

13 (A) in subsection (a)— 

14 (i) in paragraph (1), by striking 

15 ‘‘small or large group markets’’ and insert16 ing ‘‘individual or group market’’; and 

17 (ii) in paragraph (2), by inserting ‘‘or 

18 individual health insurance coverage’’ after 

19 ‘‘group health plans’’; and 

20 (B) in subsection (b)(1)(B), by inserting 

21 ‘‘individual health insurance coverage or’’ after 

22 ‘‘respect to’’; and 

23 (14) in section 2723(a)(1) (42 U.S.C. 300gg24 23), by inserting ‘‘individual or’’ before ‘‘group 

25 health insurance’’. 


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1 (b) APPLICABILITY.—Notwithstanding any other pro2 vision of the Affordable Health Choices Act, nothing in 

3 such Act (or an amendment made by such Act) shall be 

4 construed to— 

5 (1) authorize the Secretary of Health and 

6 Human Services to promulgate regulations that pro7 hibit a group health plan or health insurance issuer 

8 from carrying out utilization management techniques 

9 that are commonly used as of the date of enactment 

10 of this section; or 

11 (2) restrict the application of the amendments 

12 made by this subtitle. 

13 (c) TECHNICAL AMENDMENT TO THE EMPLOYEE RE14 TIREMENT INCOME SECURITY ACT OF 1974.—Subpart B 

15 of part 7 of subtitle A of title I of the Employee Retire16 ment Income Security Act of 1974 (29 U.S.C. 1181 et. 

17 seq.) is amended, by adding at the end the following: 

18 ‘‘SEC. 715. ADDITIONAL MARKET REFORMS. 

19 ‘‘(a) GENERAL RULE.—Except as provided in sub20 section (b)— 

21 ‘‘(1) the provisions of subpart 1 of part A of 

22 title XXVII of the Public Health Service Act (as 

23 amended by the Affordable Health Choices Act) 

24 shall apply to group health plans, and health insur25 ance issuers providing health insurance coverage in 


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1 connection with group health plans, as if included in 

2 this subpart; and 

3 ‘‘(2) to the extent that any provision of this 

4 part conflicts with a provision of such subpart 1 

5 with respect to group health plans, or health insur6 ance issuers providing health insurance coverage in 

7 connection with group health plans, the provisions of 

8 such subpart 1 shall apply. 

9 ‘‘(b) EXCEPTION.—Notwithstanding subsection (a), 

10 the provisions of sections 2701, 2702, and 2704 of title 

11 XXVII of the Public Health Service Act (as amended by 

12 the Affordable Health Choices Act) shall not apply with 

13 respect to self-insured group health plans, and the provi14 sions of this part shall continue to apply to such plans 

15 as if such sections of the Public Health Service Act (as 

16 so amended) had not been enacted.’’. 

17 (d) TECHNICAL AMENDMENT TO THE INTERNAL

18 REVENUE CODE OF 1986.—Subchapter B of chapter 100 

19 of the Internal Revenue Code of 1986 is amended by add20 ing at the end the following: 

21 ‘‘SEC. 9815. ADDITIONAL MARKET REFORMS. 

22 ‘‘(a) GENERAL RULE.—Except as provided in sub23 section (b)— 

24 ‘‘(1) the provisions of subpart 1 of part A of 

25 title XXVII of the Public Health Service Act (as 


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1 amended by the Affordable Health Choices Act) 

2 shall apply to group health plans, and health insur3 ance issuers providing health insurance coverage in 

4 connection with group health plans, as if included in 

5 this subchapter; and 

6 ‘‘(2) to the extent that any provision of this 

7 subchapter conflicts with a provision of such subpart 

8 1 with respect to group health plans, or health in9 surance issuers providing health insurance coverage 

10 in connection with group health plans, the provisions 

11 of such subpart 1 shall apply. 

12 ‘‘(b) EXCEPTION.—Notwithstanding subsection (a), 

13 the provisions of sections 2701, 2702, and 2704 of title 

14 XXVII of the Public Health Service Act (as amended by 

15 the Affordable Health Choices Act) shall not apply with 

16 respect to self-insured group health plans, and the provi17 sions of this subchapter shall continue to apply to such 

18 plans as if such sections of the Public Health Service Act 

19 (as so amended) had not been enacted.’’. 

20 SEC. 134. SAVINGS. 

21 (a) DETERMINATION.—The Secretary of the Treas22 ury, in consultation with the Secretary of Health and 

23 Human Services, shall for each fiscal year determine the 

24 amount of savings to the Federal Government as a result 

25 of the enactment of this subtitle. 


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1 (b) USE.—Notwithstanding any other provision of 

2 this subtitle (or an amendment made by this subtitle), the 

3 savings to the Federal Government generated as a result 

4 of the enactment of this subtitle shall be used for deficit 

5 reduction. 

6 SEC. 135. EFFECTIVE DATES. 

7 (a) APPLICABILITY.—Except as otherwise provided in 

8 subsection (b), this subtitle (and the amendments made 

9 by this subtitle) shall become effective for plan years be10 ginning on or after the date that is 1 year after the date 

11 of enactment of this Act. 

12 (b) DELAYED APPLICABILITY.—Sections 2701, 2702, 

13 2705, and 2706 of the Public Health Service Act (as 

14 added by section 101) shall become effective with respect 

15 to group health plans or health insurance coverage offered 

16 in a State on the date on which such State becomes a 

17 participating or establishing State under section 3104 of 

18 the Public Health Service Act (as added by section 142). 


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1 Subtitle B—Available Coverage for 

2 All Americans 

3 SEC. 141. BUILDING ON THE SUCCESS OF THE FEDERAL 

4 EMPLOYEES HEALTH BENEFITS PROGRAM 

5 AND THE HEALTH BENEFITS PROGRAM OF 

6 MOST LARGE EMPLOYERS SO ALL AMERI7 CANS HAVE AFFORDABLE HEALTH BENEFIT 

8 CHOICES. 

9 (a) FINDINGS.—The Senate finds that— 

10 (1) the Federal employees health benefits pro11 gram under chapter 89 of title 5, United States 

12 Code, allows Members of Congress, and section 514 

13 of the Employee Retirement Income Security Act of 

14 1974 allows large employers, to have affordable 

15 choices among competing health benefit plans; 

16 (2) the Federal employees health benefits pro17 gram ensures that the health benefit plans available 

18 to Members of Congress meet minimum standards of 

19 quality and effectiveness; 

20 (3) millions of Americans have no meaningful 

21 choice in health benefits, because health benefit 

22 plans are either unavailable or unaffordable; and 

23 (4) all Americans should have the same kinds 

24 of meaningful choices of health benefit plans that 

25 Members of Congress, as Federal employees, enjoy 


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1 through the Federal employees health benefits pro2 gram. 

3 (b) SENSE OF THE SENATE.—It is the sense of the 

4 Senate that Congress should establish a means for all 

5 Americans to enjoy affordable choices in health benefit 

6 plans, in the same manner that Members of Congress have 

7 such choices through the Federal employees health bene8 fits program. 

9 SEC. 142. AFFORDABLE HEALTH CHOICES FOR ALL AMERI10 CANS. 

11 (a) PURPOSE.—It is the purpose of this section to 

12 facilitate the establishment of Affordable Health Benefit 

13 Gateways in each State, with appropriate flexibility for 

14 States in establishing and administering the Gateways. 

15 (b) AMERICAN HEALTH BENEFIT GATEWAYS.—The 

16 Public Health Service Act ( 42 U.S.C. 201 et seq.) is 

17 amended by adding at the end the following: 

18 ‘‘TITLE XXXI—AFFORDABLE 

19 HEALTH CHOICES FOR ALL 

20 AMERICANS 

21 ‘‘Subtitle A—Affordable Choices 

22 ‘‘SEC. 3101. AFFORDABLE CHOICES OF HEALTH BENEFIT 

23 PLANS. 

24 ‘‘(a) ASSISTANCE TO STATES TO ESTABLISH AMER25 ICAN HEALTH BENEFIT GATEWAYS.— 


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1 ‘‘(1) PLANNING AND ESTABLISHMENT

2 GRANTS.—Not later than 60 days after the date of 

3 enactment of this section (or as soon as practicable 

4 thereafter), the Secretary shall make awards, from 

5 amounts appropriated under paragraph (5), to 

6 States in the amount specified in paragraph (2) for 

7 the uses described in paragraph (3). 

8 ‘‘(2) AMOUNT SPECIFIED.— 

9 ‘‘(A) TOTAL DETERMINED.—For each fis10 cal year, the Secretary shall determine the total 

11 amount that the Secretary will make available 

12 for grants under this subsection. 

13 ‘‘(B) STATE AMOUNT.—For each State 

14 that is awarded a grant under paragraph (1), 

15 the amount of such grants shall be based on a 

16 formula established by the Secretary under 

17 which each State shall receive an award in an 

18 amount that is based on the following two com19 ponents: 

20 ‘‘(i) A minimum amount for each 

21 State. 

22 ‘‘(ii) An additional amount based on 

23 population. 

24 The Secretary shall ensure that the aggregate 

25 amount awarded to all States under clause (i) 


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1 is not less than 60 percent of the aggregate 

2 amount awarded to all States under this sub3 paragraph. 

4 ‘‘(3) USE OF FUNDS.—A State shall use 

5 amounts awarded under this subsection for activities 

6 (including planning activities) related to establishing 

7 an American Health Benefit Gateway, as described 

8 in subsection (b). 

9 ‘‘(4) RENEWABILITY OF GRANT.— 

10 ‘‘(A) IN GENERAL.—The Secretary may 

11 renew a grant awarded under paragraph (1) if 

12 the State recipient of such grant— 

13 ‘‘(i) is making progress, as determined 

14 by the Secretary, toward— 

15 ‘‘(I) establishing a Gateway; and 

16 ‘‘(II) implementing the reforms 

17 described in subtitle A of title I of the 

18 Affordable Health Choices Act; and 

19 ‘‘(ii) is meeting such other bench20 marks as the Secretary may establish. 

21 ‘‘(B) LIMITATION.—If a State is an estab22 lishing State or a participating State (as de23 fined in section 3104), such State shall not be 

24 eligible for a grant renewal under subparagraph 

25 (A) as of the second fiscal year following the 


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1 date on which such State was deemed to be an 

2 establishing State or a participating State. 

3 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

4 There are authorized to be appropriated such sums 

5 as may be necessary to carry out this subsection in 

6 each of fiscal years 2009 through 2014. 

7 ‘‘(b) AMERICAN HEALTH BENEFIT GATEWAYS.—An 

8 American Health Benefit Gateway (referred to in this title 

9 as a ‘Gateway’) means a mechanism that— 

10 ‘‘(1) facilitates the purchase of health insurance 

11 coverage and related insurance products through the 

12 Gateway at an affordable price by qualified individ13 uals and qualified employers and reduces the cost of 

14 health care; and 

15 ‘‘(2) meets the requirements of subsection (c). 

16 ‘‘(c) REQUIREMENTS.— 

17 ‘‘(1) ESTABLISHMENT.—A Gateway shall be a 

18 governmental agency or nonprofit entity that is es19 tablished by— 

20 ‘‘(A) a State, in the case of an establishing 

21 State (as described in section 3104); or 

22 ‘‘(B) the Secretary, in the case of a par23 ticipating State (as described in section 3104). 

24 ‘‘(2) OFFERING OF COVERAGE.— 


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1 ‘‘(A) IN GENERAL.—A Gateway shall make 

2 available qualified health plans to qualified indi3 viduals and qualified employers. 

4 ‘‘(B) INCLUSION.—In making available 

5 coverage pursuant to subparagraph (A), a Gate6 way shall include a community health insurance 

7 option (as described in section 3106). 

8 ‘‘(C) LIMITATION.—A Gateway may not 

9 make available any health plan or other health 

10 insurance coverage that is not a qualified health 

11 plan. 

12 ‘‘(D) ALLOWANCE TO OFFER.—A Gateway 

13 may make available a qualified health plan not14 withstanding any provision of law that may re15 quire benefits other than the essential health 

16 benefits specified under section 3103(a). 

17 ‘‘(E) STATES MAY REQUIRE ADDITIONAL

18 BENEFITS.—Subject to the requirements of 

19 subparagraph (F), a State may require that a 

20 qualified health plan offered in such State offer 

21 benefits in addition to the essential health bene22 fits described in section 3103(a). 

23 ‘‘(F) ADDITIONAL BENEFITS.— 

24 ‘‘(i) NO ADDITIONAL FEDERAL

25 COST.—A requirement by a State under 


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1 subparagraph (E) that a qualified health 

2 plan cover benefits in addition to the es3 sential health benefits required shall not 

4 affect the amount of a credit provided 

5 under section 3111 with respect to such 

6 plan. 

7 ‘‘(ii) STATE MUST ASSUME COST.—A 

8 State shall make payments to or on behalf 

9 of an eligible individual to defray the cost 

10 of any additional benefits described in sub11 paragraph (E). 

12 ‘‘(3) FUNCTIONS.—A Gateway shall, at a min13 imum— 

14 ‘‘(A) establish procedures for the certifi15 cation, recertification, and decertification, con16 sistent with guidelines developed by the Sec17 retary under subsection (m), of health plans as 

18 qualified health plans; 

19 ‘‘(B) develop and make available tools to 

20 allow consumers to receive accurate and cul21 turally and linguistically appropriate informa22 tion on— 

23 ‘‘(i) expected premiums and out of 

24 pocket expenses (taking into account any 


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1 credits for which such individual is eligible 

2 under section 3111); 

3 ‘‘(ii) the availability of in-network and 

4 out-of-network providers; 

5 ‘‘(iii) the costs of any surcharge as6 sessed under paragraph (4); 

7 ‘‘(iv) data, by plan, that reflects the 

8 frequency with which preventive services 

9 rated ‘A’ or ‘B’ by the U.S. Preventive 

10 Services Task Force or recommended by 

11 the Advisory Committee on Immunization 

12 Practices are utilized by enrollees, a com13 parison of such data to the average fre14 quency with which such preventive services 

15 are utilized by enrollees across all qualified 

16 health plans, and whether such preventive 

17 services are utilized by enrollees as fre18 quently as recommended; 

19 ‘‘(v) medical loss ratios, as reported 

20 under section 2704(a); 

21 ‘‘(vi) any quality measures for health 

22 plan performance endorsed under section 

23 399JJ; and 

24 ‘‘(vii) such other matters relating to 

25 consumer costs and expected experience 


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1 under the plan as a Gateway may deter2 mine necessary; 

3 ‘‘(C) utilize the administrative simplifica4 tion measures and standards developed under 

5 section 222 of the Affordable Health Choices 

6 Act; 

7 ‘‘(D) enter into agreements, to the extent 

8 determined appropriate by the Gateway, with 

9 navigators, as described in section 3105; 

10 ‘‘(E) facilitate the purchase of coverage for 

11 long-term services and supports; 

12 ‘‘(F) collect, analyze, and respond to com13 plaints and concerns from enrollees regarding 

14 coverage provided through the Gateway; 

15 ‘‘(G) provide for the operation of a toll-free 

16 telephone hotline to respond to requests for as17 sistance; and 

18 ‘‘(H) maintain an Internet website through 

19 which enrollees and prospective enrollees of 

20 qualified health plans may obtain standardized 

21 comparative information on such plans. 

22 ‘‘(4) SURCHARGES.— 

23 ‘‘(A) IN GENERAL.—A Gateway may as24 sess a surcharge on all health insurance issuers 

25 offering qualified health plans through the 


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1 Gateway to pay for the administrative and oper2 ational expenses of the Gateway. 

3 ‘‘(B) LIMITATION.—A surcharge described 

4 in subparagraph (A) may not exceed 4 percent 

5 of the premiums collected by a qualified health 

6 plan. 

7 ‘‘(C) FURTHER LIMITATION.—No funds 

8 collected through a Gateway surcharge for ad9 ministrative and operational expenses may be 

10 used for staff retreats, promotional giveaways, 

11 excessive executive compensation, or promotion 

12 of Federal or State legislative and regulatory 

13 modifications. 

14 ‘‘(5) RISK ADJUSTMENT PAYMENT.— 

15 ‘‘(A) ESTABLISHING AND PARTICIPATING

16 STATES.— 

17 ‘‘(i) LOW ACTUARIAL RISK PLANS.— 

18 Using the criteria and methods developed 

19 under subparagraph (B), each establishing 

20 State or participating State (as defined in 

21 section 3104) shall assess a charge on 

22 health plans and health insurance issuers 

23 (with respect to health insurance coverage) 

24 described in subparagraph (C) if the actu25 arial risk of the enrollees of such plans or 


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1 coverage for a year is less than the average 

2 actuarial risk of all enrollees in all plans or 

3 coverage in such State for such year that 

4 are not self-insured group health plans 

5 (which are subject to the provisions of the 

6 Employee Retirement Income Security Act 

7 of 1974). 

8 ‘‘(ii) HIGH ACTUARIAL RISK PLANS.— 

9 Using the criteria and methods developed 

10 under subparagraph (B), each establishing 

11 State or participating State (as defined in 

12 section 3104) shall provide a payment to 

13 health plans and health insurance issuers 

14 (with respect to health insurance coverage) 

15 described in subparagraph (C) if the actu16 arial risk of the enrollees of such plans or 

17 coverage for a year is greater than the av18 erage actuarial risk of all enrollees in all 

19 plans and coverage in such State for such 

20 year that are not self-insured group health 

21 plans (which are subject to the provisions 

22 of the Employee Retirement Income Secu23 rity Act of 1974). 

24 ‘‘(B) CRITERIA AND METHODS.—The Sec25 retary, in consultation with States, shall estabVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 lish criteria and methods to be used in carrying 

2 out the risk adjustment activities under this 

3 paragraph. The Secretary may utilize criteria 

4 and methods similar to the criteria and meth5 ods utilized under part C or D of title XVIII 

6 of the Social Security Act. 

7 ‘‘(C) SCOPE.—A health plan or a health 

8 insurance issuer is described in this subpara9 graph if such health plan or health insurance 

10 issuer provides coverage for an individual or for 

11 an employer group the size of which does not 

12 exceed— 

13 ‘‘(i) in the case of an employer with 

14 its primary place of business located in an 

15 establishing State, the criteria relating to 

16 the size of employers established by such 

17 State as described in section 

18 3116(a)(2)(A)(ii)(I); or 

19 ‘‘(ii) in the case of an employer with 

20 its primary place of business located in a 

21 participating State, the criteria relating to 

22 the size of employers established by the 

23 Secretary as described in section 

24 3116(a)(2)(A)(ii)(II). 

25 ‘‘(6) FACILITATING ENROLLMENT.— 


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1 ‘‘(A) IN GENERAL.—A Gateway shall 

2 (through, to the extent practicable, the use of 

3 information technology) implement policies and 

4 procedures to— 

5 ‘‘(i) facilitate the identification of in6 dividuals who lack qualifying coverage; and 

7 ‘‘(ii) assist such individuals in enroll8 ing in— 

9 ‘‘(I) a qualified health plan that 

10 is affordable and available to such in11 dividual, if such individual is a quali12 fied individual; 

13 ‘‘(II) the medicaid program 

14 under title XIX of the Social Security 

15 Act, if such individual is eligible for 

16 such program; 

17 ‘‘(III) the CHIP program under 

18 title XXI of the Social Security Act, if 

19 such individual is eligible for such 

20 program; or 

21 ‘‘(IV) other Federal programs in 

22 which such individual is eligible to 

23 participate. 

24 ‘‘(B) CHOICE FOR INDIVIDUALS ELIGIBLE

25 FOR CHIP.—A qualified individual who is eligiVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 ble for the Children’s Health Insurance Pro2 gram under title XXI of the Social Security Act 

3 may elect to enroll in such program or in a 

4 qualified health plan. Where such individual is 

5 a minor child, such election shall be made by 

6 the parent or guardian of such child. 

7 ‘‘(C) OVERSIGHT.—The Secretary shall 

8 oversee the implementation of subparagraph 

9 (A)(ii) to ensure that individuals are assisted to 

10 enroll in the program most appropriate under 

11 such subparagraph for each such individual. 

12 ‘‘(D) ACCESSIBILITY OF MATERIALS.—Any 

13 materials used by a Gateway to carry out this 

14 paragraph shall be provided in a form and man15 ner calculated to be understood by individuals 

16 who may apply to be enrollees in a qualified 

17 health plan, taking into account potential lan18 guage barriers and disabilities of individuals. 

19 ‘‘(7) CONSULTATION.—A Gateway shall consult 

20 with stakeholders relevant to carrying out the activi21 ties under this subsection, including— 

22 ‘‘(A) educated health care consumers who 

23 are enrollees in qualified health plans; 


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1 ‘‘(B) individuals and entities with experi2 ence in facilitating enrollment in qualified 

3 health plans; 

4 ‘‘(C) representatives of small businesses 

5 and self-employed individuals; 

6 ‘‘(D) State Medicaid offices; and 

7 ‘‘(E) advocates for enrolling hard to reach 

8 populations. 

9 ‘‘(8) STANDARDS AND PROTOCOLS.— 

10 ‘‘(A) IN GENERAL.—The Secretary, in con11 sultation with the Office of the National Coor12 dinator for Health Information Technology, 

13 shall develop interoperable, secure, scalable, and 

14 reusable standards and protocols that facilitate 

15 enrollment of individuals in Federal and State 

16 health and human services programs. 

17 ‘‘(B) COORDINATION.—The Secretary shall 

18 facilitate enrollment of individuals in programs 

19 described in subparagraph (A) through methods 

20 which shall include— 

21 ‘‘(i) electronic matching against exist22 ing Federal and State data to serve as evi23 dence of eligibility and digital documenta24 tion in lieu of paper-based documentation; 


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1 ‘‘(ii) capability for individuals to 

2 apply, recertify, and manage eligibility in3 formation online, including conducting 

4 real-time queries against databases for ex5 isting eligibility prior to submitting appli6 cations; and 

7 ‘‘(iii) other functionalities necessary to 

8 provide eligible individuals with a stream9 lined enrollment process. 

10 ‘‘(C) ASSISTANCE.—The Secretary shall 

11 award grants to enhance community-based en12 rollment to— 

13 ‘‘(i) States to assist such States in— 

14 ‘‘(I) contracting with qualified 

15 technology vendors to develop or ac16 quire electronic enrollment software 

17 systems; 

18 ‘‘(II) contracting with community 

19 and consumer focused nonprofit orga20 nizations with experience working 

21 with consumers, including the unin22 sured and the underinsured, to estab23 lish Statewide helplines for enrollment 

24 assistance and referrals; and 


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1 ‘‘(III) establishing public edu2 cation campaigns through grants to 

3 qualifying organizations for the design 

4 and implementation of public edu5 cation campaigns targeting uninsured 

6 and traditionally underserved commu7 nities; and 

8 ‘‘(ii) community-based organizations 

9 for infrastructure and training to establish 

10 electronic assistance programs. 

11 ‘‘(9) NOTIFICATION.—With respect to the 

12 standards and protocols developed under paragraph 

13 (8), the Secretary— 

14 ‘‘(A) shall notify States of such standards 

15 and protocols; and 

16 ‘‘(B) may require, as a condition of receiv17 ing Federal funds, that States or other entities 

18 incorporate such standards and protocols into 

19 such investments. 

20 ‘‘(10) PUBLICATION OF COSTS.—A Gateway 

21 shall publish the average costs of income or other 

22 taxes, licensing or regulatory fees, and any sur23 charges imposed by the Gateway, and the adminis24 trative costs of such Gateway, on an Internet 

25 website to educate consumers on such costs. Such 


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1 information shall also include monies lost to waste, 

2 fraud, and abuse. 

3 ‘‘(d) CERTIFICATION.—A Gateway may certify a 

4 health plan as a qualified health plan if— 

5 ‘‘(1) such health plan meets the requirements of 

6 subsection (m); 

7 ‘‘(2) the Gateway determines that making avail8 able such health plan through such Gateway is in 

9 the interests of qualified individuals and qualified 

10 employers in the States or States in which such 

11 Gateway operates, except that the Gateway may not 

12 exclude a health plan— 

13 ‘‘(A) on the basis that such plan is a fee14 for-service plan; 

15 ‘‘(B) through the imposition of premium 

16 price controls; or 

17 ‘‘(C) on the basis that the plan provides 

18 treatments necessary to prevent patients’ 

19 deaths in circumstances the Gateway deter20 mines are inappropriate or to costly; and 

21 ‘‘(3) the Gateway determines that the plan has 

22 not established a pattern or practice under which 

23 benefits covered by the plan are denied to covered 

24 individuals on the basis of the individuals’ age or ex25 pected length of life or of the individuals’ present or 


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1 predicted disability, degree of medical dependency, 

2 or quality of life. 

3 ‘‘(e) GUIDANCE.—The Secretary shall develop guid4 ance that may be used by a Gateway to carry out the ac5 tivities described in this section. 

6 ‘‘(f) FLEXIBILITY.— 

7 ‘‘(1) REGIONAL OR OTHER INTERSTATE GATE8 WAYS.—A Gateway may operate in more than one 

9 State, provided that each State in which such Gate10 way operates permits such operation. 

11 ‘‘(2) SUBSIDIARY GATEWAYS.—A State may es12 tablish one or more subsidiary Gateway, provided 

13 that— 

14 ‘‘(A) each such Gateway serves a geo15 graphically distinct area; and 

16 ‘‘(B) the area served by each such Gate17 way is at least as large as a community rating 

18 area described in section 2701. 

19 ‘‘(g) NO LIMITATION ON CONTRACTING BASED ON

20 ABORTION.—No individual health care provider or health 

21 care facility may be excluded from contracting with a 

22 health insurance issuer participating in the Gateway on 

23 the basis that the provider or facility performs abortions 

24 or the provider or facility refuses to perform abortions, 

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1 trary to the religious or moral beliefs of the provider or 

2 facility. 

3 ‘‘(h) PORTALS TO STATE GATEWAY.—The Secretary 

4 shall establish a mechanism, including an Internet 

5 website, through which a resident of any State may iden6 tify any Gateway operating in such State. 

7 ‘‘(i) CHOICE.— 

8 ‘‘(1) QUALIFIED INDIVIDUALS.—A qualified in9 dividual may enroll in any qualified health plan 

10 available to such individual. 

11 ‘‘(2) QUALIFIED EMPLOYERS.— 

12 ‘‘(A) EMPLOYER MAY SPECIFY TIER.—A 

13 qualified employer may provide support for cov14 erage of employees under a qualified health 

15 plan by selecting any tier of cost sharing de16 scribed in section 3111(a)(1). 

17 ‘‘(B) EMPLOYEE MAY CHOOSE PLANS

18 WITHIN A TIER.—Each employee of a qualified 

19 employer may choose to enroll in a qualified 

20 health plan that offers coverage at the tier of 

21 cost sharing selected by an employer, as de22 scribed in subparagraph (A). 

23 ‘‘(3) SELF-EMPLOYED INDIVIDUALS.— 

24 ‘‘(A) DEEMING.—An individual who is self25 employed (as defined in section 401(c)(1) of the 


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1 Internal Revenue Code of 1986) shall be 

2 deemed to be a qualified employer unless such 

3 individual notifies the applicable Gateway that 

4 such individual elects to be considered a quali5 fied individual. 

6 ‘‘(B) ELIGIBILITY.—In the case of a self7 employed individual making the election de8 scribed in subparagraph (A)— 

9 ‘‘(i) the income of such individual for 

10 purposes of section 3111 shall be deemed 

11 to be the total business income of such in12 dividual; 

13 ‘‘(ii) premium payments made by such 

14 individual to a qualified health plan shall 

15 not be treated as employer-provided cov16 erage under section 106(a) of the Internal 

17 Revenue Code of 1986; and 

18 ‘‘(iii) the individual shall not be eligi19 ble for a credit under section 3112. 

20 ‘‘(j) PAYMENT OF PREMIUMS BY QUALIFIED INDI21 VIDUALS.—A qualified individual enrolled in any qualified 

22 health plan may pay any applicable premium owed by such 

23 individual to the health insurance issuer issuing such 

24 qualified health plan. 

25 ‘‘(k) SINGLE RISK POOL.— 


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1 ‘‘(1) INDIVIDUAL MARKET.—A health insurance 

2 issuer shall consider all enrollees in an individual 

3 plan, including individuals who do not purchase such 

4 a plan through the Gateway, to be members of a sin5 gle risk pool. 

6 ‘‘(2) GROUP HEALTH INSURANCE POLICIES.—A 

7 health insurance issuer shall consider all enrollees in 

8 a small group health plan, other than a self-insured 

9 group health plan, including individuals who do not 

10 purchase such a plan through the Gateway, to be 

11 members of a single risk pool. 

12 ‘‘(l) EMPOWERING CONSUMER CHOICE.— 

13 ‘‘(1) CONTINUED OPERATION OF MARKET OUT14 SIDE GATEWAYS.—Nothing in this title shall be con15 strued to prohibit a health insurance issuer from of16 fering a health insurance policy or providing cov17 erage under such policy to a qualified individual 

18 where such policy is not a qualified health plan. 

19 Nothing in this title shall be construed to prohibit 

20 a qualified individual from enrolling in a health in21 surance plan where such plan is not a qualified 

22 health plan. 

23 ‘‘(2) CONTINUED OPERATION OF STATE BEN24 EFIT REQUIREMENTS.—Nothing in this title shall be 

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1 ation of any requirement under State law with re2 spect to any policy or plan that is not a qualified 

3 health plan to offer benefits required under State 

4 law. 

5 ‘‘(3) VOLUNTARY NATURE OF A GATEWAY.— 

6 ‘‘(A) CHOICE TO ENROLL OR NOT TO EN7 ROLL.—Nothing in this title shall be construed 

8 to restrict the choice of a qualified individual to 

9 enroll or not to enroll in a qualified health plan 

10 or to participate in a Gateway. 

11 ‘‘(B) PROHIBITION AGAINST COMPELLED

12 ENROLLMENT.—Nothing in this title shall be 

13 construed to compel an individual to enroll in a 

14 qualified health plan or to participate in a 

15 Gateway. 

16 ‘‘(m) CRITERIA FOR CERTIFICATION.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall, by 

18 regulation, establish criteria for certification of 

19 health plans as qualified health plans. Such criteria 

20 shall require that, to be certified, a plan— 

21 ‘‘(A) not employ marketing practices that 

22 have the effect of discouraging the enrollment 

23 in such plan by individuals with significant 

24 health needs; 


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1 ‘‘(B) employ methods to ensure that insur2 ance products are simple, comparable, and 

3 structured for ease of consumer choice; 

4 ‘‘(C) ensure a wide choice of providers (in 

5 a manner consistent with applicable network 

6 adequacy provisions under section 2702(c)); 

7 ‘‘(D) include within health insurance plan 

8 networks those essential community providers, 

9 where available, that serve predominately low10 income, medically-underserved individuals, such 

11 as health care providers defined in section 

12 340B(a)(4) of the Public Health Service Act 

13 and providers described in section 

14 1927(c)(1)(D)(i)(IV) of the Social Security Act 

15 as set forth by section 221 of Public Law 111- 

16 8; 

17 ‘‘(E) make available to individuals enrolled 

18 in, or seeking to enroll in, such plan a detailed 

19 description of— 

20 ‘‘(i) benefits offered, including maxi21 mums, limitations (including differential 

22 cost-sharing for out of network services), 

23 exclusions and other benefit limitations; 

24 ‘‘(ii) the service area; 

25 ‘‘(iii) required premiums; 


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1 ‘‘(iv) cost-sharing requirements; 

2 ‘‘(v) the manner in which enrollees ac3 cess providers; and 

4 ‘‘(vi) the grievance and appeals proce5 dures; 

6 ‘‘(F) provide coverage for at least the es7 sential health care benefits established under 

8 section 3103(a); 

9 ‘‘(G)(i) is accredited by the National Com10 mittee for Quality Assurance or by any other 

11 entity recognized by the Secretary for the ac12 creditation of health insurance issuers or plans; 

13 or 

14 ‘‘(ii) receives such accreditation within a 

15 period established by a Gateway for such ac16 creditation that is applicable to all qualified 

17 health plans; 

18 ‘‘(H) implement a quality improvement 

19 strategy described in subsection (n)(1); 

20 ‘‘(I) have adequate procedures in place for 

21 appeals of coverage determinations; 

22 ‘‘(J) may not establish a benefit design 

23 that is likely to substantially discourage enroll24 ment by certain qualified individuals in such 

25 plan; and 


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1 ‘‘(K) report to the applicable Gateway data 

2 on any quality measures for health plan per3 formance endorsed under section 399JJ. 

4 ‘‘(2) REQUEST TO NATIONAL ASSOCIATION OF

5 INSURANCE COMMISSIONERS.—The Secretary shall 

6 request the National Association of Insurance Com7 missioners to develop and submit to the Secretary 

8 model criteria for the certification of qualified health 

9 plans, that address the elements described in sub10 paragraphs (A) through (K) of paragraph (1). In de11 veloping such criteria, the National Association of 

12 Insurance Commissioners shall consult with appro13 priate Federal agencies, consumer representatives, 

14 insurance carriers, and other stakeholders. 

15 ‘‘(3) REQUIRED CONSIDERATION.—If the model 

16 criteria described in paragraph (2) are submitted to 

17 the Secretary by the date that is 9 months after the 

18 date on which a request is made under such para19 graph, the Secretary shall consider such model cri20 teria in promulgating the regulations under para21 graph (1). 

22 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

23 paragraph (1)(D) shall be construed to require a 

24 qualified health plan to contract with a provider de25 scribed in such paragraph if such provider refuses to 


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1 accept the generally applicable payment rates of 

2 such plan. 

3 ‘‘(n) REWARDING QUALITY THROUGH MARKET4 BASED INCENTIVES.— 

5 ‘‘(1) STRATEGY DESCRIBED.—A strategy de6 scribed in this paragraph is a payment structure 

7 that provides increased reimbursement or other in8 centives for— 

9 ‘‘(A) improving health outcomes through 

10 the implementation of activities that shall in11 clude quality reporting, effective case manage12 ment, care coordination, chronic disease man13 agement, medication and care compliance initia14 tives, including through the use of the medical 

15 home model as defined in section 212 of the Af16 fordable Health Choices Act, for treatment or 

17 services under the plan or coverage; 

18 ‘‘(B) the implementation of activities to 

19 prevent hospital readmissions through a com20 prehensive program for hospital discharge that 

21 includes patient-centered education and coun22 seling, comprehensive discharge planning, and 

23 post discharge reinforcement by an appropriate 

24 health care professional; 


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1 ‘‘(C) the implementation of activities to 

2 improve patient safety and reduce medical er3 rors through the appropriate use of best clinical 

4 practices, evidence based medicine, and health 

5 information technology under the plan or cov6 erage; and 

7 ‘‘(D) the implementation of wellness and 

8 health promotion activities. 

9 ‘‘(2) GUIDELINES.—The Secretary, in consulta10 tion with experts in health care quality and stake11 holders, shall develop guidelines concerning the mat12 ters described in paragraph (1). 

13 ‘‘(3) REQUIREMENTS.—The guidelines devel14 oped under paragraph (2) shall require the periodic 

15 reporting to the applicable Gateway of the activities 

16 that a qualified health plan has conducted to imple17 ment a strategy described in paragraph (1). 

18 ‘‘(o) NO INTERFERENCE WITH STATE REGULATORY

19 AUTHORITY.—Nothing in this title shall be construed to 

20 preempt any State law that does not prevent the applica21 tion of the provisions of this title. 

22 ‘‘(p) QUALITY IMPROVEMENT.— 

23 ‘‘(1) ENHANCING PATIENT SAFETY.—Beginning 

24 on January 1, 2012 a qualified health plan may con25 tract with— 


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1 ‘‘(A) a hospital with greater than 50 beds 

2 only if such hospital— 

3 ‘‘(i) utilizes a patient safety evaluation 

4 system as described in part C of title IX; 

5 and 

6 ‘‘(ii) implements a mechanism to en7 sure that each patient receives a com8 prehensive program for hospital discharge 

9 that includes patient-centered education 

10 and counseling, comprehensive discharge 

11 planning, and post discharge reinforcement 

12 by an appropriate health care professional; 

13 or 

14 ‘‘(B) a health care provider if such pro15 vider implements such mechanisms to improve 

16 health care quality as the Secretary may by reg17 ulation require. 

18 ‘‘(2) EXCEPTIONS.—The Secretary may estab19 lish reasonable exceptions to the requirements de20 scribed in paragraph (1). 

21 ‘‘(3) ADJUSTMENT.—The Secretary may by 

22 regulation adjust the number of beds described in 

23 paragraph (1)(A). 

24 ‘‘(q) CONTINUED APPLICABILITY OF MENTAL

25 HEALTH PARITY.—Section 2716 shall apply to qualified 


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1 health plans in the same manner and to the same extent 

2 as such section applies to health insurance issuers and 

3 group health plans. 

4 ‘‘(r) PROMOTION OF INFORMED CHOICE OF HEALTH

5 INSURANCE COVERAGE.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall develop 

7 standards for use by health insurance issuers offer8 ing health insurance coverage through the Gateway 

9 in the individual or group market in compiling and 

10 providing to enrollees a summary of benefits expla11 nation that accurately represents the benefits and 

12 coverage provided by the issuer under each of its ap13 plicable health insurance products. In developing 

14 such standards, the Secretary shall consult with the 

15 National Association of Insurance Commissioners, a 

16 working group composed of representatives of health 

17 insurance-related consumer advocacy organizations, 

18 health insurance issuers, health care professionals, 

19 patient advocates including those representing indi20 viduals with limited English proficiency, and other 

21 qualified individuals. 

22 ‘‘(2) REQUIREMENTS.—The standards for the 

23 summary of benefits explanation developed under 

24 paragraph (1) shall provide for the following: 


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1 ‘‘(A) APPEARANCE.—The standards shall 

2 ensure that the summary is presented in a uni3 form format. 

4 ‘‘(B) LANGUAGE.—The standards shall en5 sure that the language used in the summary is 

6 presented in a manner determined to be under7 standable by the average health plan enrollee. 

8 ‘‘(C) CONTENTS.—The standards shall en9 sure that the summary includes the following: 

10 ‘‘(i) Information determined to be es11 sential to a consumer’s understanding of 

12 the applicable health insurance plan bene13 fits. 

14 ‘‘(ii) Uniform definitions of standard 

15 insurance terms including premium, de16 ductible, co-insurance, co-payment, out-of17 pocket limit, preferred provider, non-pre18 ferred provider, out-of-network co-pay19 ments, usual, customary and reasonable 

20 fees, excluded services, grievance and ap21 peals, prior authorization, precertification, 

22 and such other terms as determined by the 

23 Secretary so that consumers may compare 

24 health insurance coverage and understand 

25 the terms of coverage. 


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1 ‘‘(iii) Uniform definitions of medical 

2 terms including hospitalization, hospital 

3 outpatient care, emergency room care, phy4 sician services, prescription drug coverage, 

5 durable medical equipment, home health 

6 care, skilled nursing care, rehabilitation 

7 services, hospice services, emergency med8 ical transportation, and such other terms 

9 as determined by the Secretary so that 

10 consumers may compare the medical bene11 fits and understand the extent of those 

12 medical benefits (or exceptions to those 

13 benefits). 

14 ‘‘(iv) A statement of whether the plan 

15 meets minimum qualifying coverage (when 

16 effective under section 3103.) 

17 ‘‘(v) Examples to illustrate common 

18 benefits scenarios, including scenarios that 

19 illustrate the health care needs of preg20 nancy and of at least several serious or 

21 chronic medical conditions. 

22 ‘‘(vi) Illustrations that enhance con23 sumer understanding of the explanation. 

24 ‘‘(3) REQUIREMENT TO PROVIDE.—Not later 

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1 ards under paragraph (1), each health insurance 

2 issuer offering health insurance coverage through 

3 the Gateway shall, prior to any enrollment restric4 tion, provide annually to enrollees and potential en5 rollees a summary of benefits explanation pursuant 

6 to the standards developed by the Secretary under 

7 paragraph (1) 

8 ‘‘(4) PREEMPTION.—The standards developed 

9 under paragraph (1) shall preempt any related State 

10 standards that require summary of benefits health 

11 plan explanations that provide less information to 

12 consumers, as determined by the Secretary. 

13 ‘‘(5) FAILURE TO PROVIDE.—A health insur14 ance issuer that willfully fails to provide the infor15 mation required under this subsection shall be sub16 ject to a fine of not more than $1,000 for each such 

17 failure. Such failure with respect to each enrollee 

18 shall constitute a separate offense for purposes of 

19 this paragraph. 

20 ‘‘(6) APPLICATION.—The provisions of this sub21 section shall apply to health insurance coverage of22 fered through the Gateway. The Secretary shall 

23 evaluate the impact on consumers of expanding the 

24 application of the provisions of this subsection to ad25 ditional health insurance issuers. 


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1 ‘‘(s) DISCLOSURE OF INFORMATION.— 

2 ‘‘(1) IN GENERAL.—In connection with the of3 fering of any health insurance coverage in the indi4 vidual or group market through a Gateway, a health 

5 insurance issuer— 

6 ‘‘(A) shall disclose to such individual or 

7 employer as part of its solicitation and sales 

8 materials, the information described in para9 graph (2); 

10 ‘‘(B) shall disclose to such individual or 

11 employer enrolled in such plan any change and 

12 an explanation of such change with respect to 

13 the information described in paragraph (2) with 

14 reasonable and timely advance notice with re15 spect to such change; 

16 ‘‘(C) upon the request of such individual or 

17 employer, shall provide the information de18 scribed in paragraph (2); and 

19 ‘‘(D) shall disclose such information as the 

20 Secretary may require in order to ensure com21 pliance with consumer protection provisions 

22 under this title. 

23 ‘‘(2) INFORMATION DESCRIBED.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (C), with respect to a health insurance 


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1 issuer offering health insurance coverage in the 

2 individual or group market through a Gateway, 

3 information disclosed under this paragraph 

4 shall include— 

5 ‘‘(i) the provisions of such coverage 

6 concerning the issuer’s right to change pre7 mium rates, co-payments, in- and out-of8 provider networks, or any other informa9 tion as determined by the Secretary; and 

10 ‘‘(ii) the benefits and premiums avail11 able under all health insurance coverage 

12 for which an individual or employers is 

13 qualified. 

14 ‘‘(B) FORM OF INFORMATION.—Informa15 tion shall be provided under this paragraph in 

16 a manner determined to be understandable by 

17 the average employer or individual and shall be 

18 sufficient to reasonably inform such employer 

19 or individual of their rights and obligations 

20 under the health insurance coverage involved. 

21 ‘‘(C) EXCEPTION.—Information described 

22 under this paragraph shall not include informa23 tion that is proprietary or trade secret informa24 tion. 


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1 ‘‘SEC. 3102. FINANCIAL INTEGRITY. 

2 ‘‘(a) ACCOUNTING FOR EXPENDITURES.— 

3 ‘‘(1) IN GENERAL.—A Gateway shall keep an 

4 accurate accounting of all activities, receipts, and ex5 penditures and shall annually submit to the Sec6 retary a report concerning such accountings. 

7 ‘‘(2) INVESTIGATIONS.—The Secretary may in8 vestigate the affairs of a Gateway, may examine the 

9 properties and records of a Gateway, and may re10 quire periodical reports in relation to activities un11 dertaken by a Gateway. A Gateway shall fully co12 operate in any investigation conducted under this 

13 paragraph. 

14 ‘‘(3) AUDITS.—A Gateway shall be subject to 

15 annual audits by the Secretary. 

16 ‘‘(4) PATTERN OF ABUSE.—If the Secretary de17 termines that a Gateway or a State has engaged in 

18 serious misconduct with respect to compliance with 

19 the requirements of, or carrying out activities re20 quired under, this title, the Secretary may rescind 

21 from payments otherwise due to such State involved 

22 under this or any other Act administered by the Sec23 retary an amount not to exceed 1 percent of such 

24 payments per year until corrective actions are taken 

25 by the State that are determined to be adequate by 

26 the Secretary. 


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1 ‘‘(5) PROTECTIONS AGAINST FRAUD AND

2 ABUSE.—With respect to activities carried out under 

3 this title, the Secretary shall provide for the efficient 

4 and non-discriminatory administration of Gateway 

5 activities and implement any measure or procedure 

6 that— 

7 ‘‘(A) the Secretary determines is appro8 priate to reduce fraud and abuse in the admin9 istration of this title; and 

10 ‘‘(B) the Secretary has authority to imple11 ment under this title or any other Act; 

12 ‘‘(6) APPLICATION OF THE FALSE CLAIMS

13 ACT.— 

14 ‘‘(A) IN GENERAL.—Payments made by, 

15 through, or in connection with a Gateway are 

16 subject to the False Claims Act (31 U.S.C. 

17 3729 et seq.) if those payments include any 

18 Federal funds. Compliance with the require19 ments of this Act concerning eligibility for a 

20 health insurance issuer to participate in the 

21 Gateway shall be a material condition of an 

22 issuer’s entitlement to receive payments, includ23 ing subsidy payments, through the Gateway. 

24 ‘‘(B) DAMAGES.—Notwithstanding para25 graph (1) of section 3729(a) of title 31, United 


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1 States Code, and subject to paragraph (2) of 

2 such section, the civil penalty assessed under 

3 the False Claims Act on any person found liable 

4 under such Act as described in subparagraph 

5 (A) shall be increased by not less than 3 times 

6 and not more than 6 times the amount of dam7 ages which the Government sustains because of 

8 the act of that person. 

9 ‘‘(b) GAO OVERSIGHT.—Not later than 5 years after 

10 the date of enactment of this section, the Comptroller 

11 General shall conduct an ongoing study of Gateway activi12 ties and the enrollees in qualified health plans offered 

13 through Gateways. Such study shall review— 

14 ‘‘(1) the operations and administration of Gate15 ways, including surveys and reports of qualified 

16 health plans offered through Gateways and on the 

17 experience of such plans (including data on enrollees 

18 in Gateways and individuals purchasing health in19 surance coverage outside of Gateways), the expenses 

20 of Gateways, claims statistics relating to qualified 

21 health plans, complaints data relating to such plans, 

22 and the manner in which Gateways meets their 

23 goals; 

24 ‘‘(2) any significant observations regarding the 

25 utilization and adoption of Gateways; 


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1 ‘‘(3) where appropriate, recommendations for 

2 improvements in the operations or policies of Gate3 ways; and 

4 ‘‘(4) how many physicians, by area and spe5 cialty, are not taking or accepting new patients en6 rolled in Federal Government health care programs, 

7 and the adequacy of provider networks of Federal 

8 Government health care programs. 

9 ‘‘SEC. 3103. PROGRAM DESIGN. 

10 ‘‘(a) PROGRAM DESIGN.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall estab12 lish the following: 

13 ‘‘(A) Subject to paragraph (2), the essen14 tial health care benefits eligible for credits 

15 under section 3111, where such benefits shall 

16 include at least the following general categories: 

17 ‘‘(i) Ambulatory patient services. 

18 ‘‘(ii) Emergency services. 

19 ‘‘(iii) Hospitalization. 

20 ‘‘(iv) Maternity and newborn care. 

21 ‘‘(v) Mental health and substance 

22 abuse services. 

23 ‘‘(vi) Prescription drugs. 

24 ‘‘(vii) Rehabilitative and habilitative 

25 services and devices. 


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1 ‘‘(viii) Laboratory services. 

2 ‘‘(ix) Preventive and wellness services. 

3 ‘‘(x) Pediatric services, including oral 

4 and vision care. 

5 ‘‘(B) The criteria that coverage must meet 

6 to be considered minimum qualifying coverage. 

7 ‘‘(C) The conditions under which coverage 

8 shall be considered affordable and available cov9 erage for individuals and families at different 

10 income levels. 

11 ‘‘(D) The essential benefits provided for in 

12 subparagraph (A) shall include a requirement 

13 that there be non-discrimination in health care 

14 in a manner that, with respect to an individual 

15 who is eligible for medical or surgical care 

16 under a qualified health plan offered through a 

17 Gateway, prohibits the Administrator of the 

18 Gateway, or a qualified health plan offered 

19 through the Gateway, from denying such indi20 vidual benefits for religious or spiritual health 

21 care, except that such religious or spiritual 

22 health care shall be an expense eligible for de23 duction as a medical care expense as deter24 mined by Internal Revenue Service Rulings inVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00091 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 terpreting section 213(d) of the Internal Rev2 enue Code of 1986 as of January 1, 2009. 

3 ‘‘(2) LIMITATION.—The Secretary shall ensure 

4 that the scope of the essential health benefits under 

5 paragraph (1)(A) is equal to the scope of benefits 

6 provided under a typical employer plan, as deter7 mined by the Secretary. 

8 ‘‘(3) CERTIFICATION.—In establishing the es9 sential health benefits described in paragraph 

10 (1)(A), the Secretary shall submit a report to the 

11 appropriate committees of Congress containing a 

12 certification from the Chief Actuary of the Centers 

13 for Medicare & Medicaid Services that such essential 

14 health benefits meet the limitation described in para15 graph (2). 

16 ‘‘(b) NATIONAL INDEPENDENT COMMISSION ON ES17 SENTIAL HEALTH CARE BENEFITS.— 

18 ‘‘(1) ESTABLISHMENT.—There is established a 

19 temporary advisory commission to be known as the 

20 National Independent Commission on Essential 

21 Health Care Benefits (in this section referred to as 

22 the ‘Commission’). 

23 ‘‘(2) DUTIES.—The Commission shall: 

24 ‘‘(A) Review and analyze the benefits of25 fered under typical employer-sponsored health 


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1 plans, and State laws requiring coverage of 

2 specified items and services in the individual 

3 and group insurance markets. 

4 ‘‘(B) Hold public hearings, meetings, or 

5 other public listening sessions not less than 3 

6 times to take testimony and receive such evi7 dence as the Commission considers advisable to 

8 carry out activities under this section. 

9 ‘‘(C) Make recommendations to the Sec10 retary regarding the specific items and services 

11 that should be included in the essential heath 

12 care benefits package eligible for credits under 

13 section 3111. 

14 ‘‘(3) CONSIDERATIONS.—The Commission shall 

15 consider— 

16 ‘‘(A) the clinical appropriateness and effec17 tiveness of the benefits covered; 

18 ‘‘(B) the affordability of the benefits cov19 ered; 

20 ‘‘(C) the financial protection of enrollees 

21 against high healthcare expenses; 

22 ‘‘(D) access to necessary healthcare serv23 ices, including primary and preventive health 

24 services; 


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1 ‘‘(E) existing State laws that require cov2 erage of health care items or services in the in3 dividual and group markets; and 

4 ‘‘(F) the potential of additional or ex5 panded benefits to increase costs and the inter6 actions between the addition or expansion of 

7 benefits and reductions in existing benefits to 

8 meet the actuarial limitations described in sub9 section (a)(2). 

10 ‘‘(4) MEMBERSHIP.— 

11 ‘‘(A) NUMBER AND APPOINTMENT.—The 

12 Commission shall be composed of 17 members 

13 to be appointed by the Secretary. 

14 ‘‘(B) QUALIFICATIONS.— 

15 ‘‘(i) IN GENERAL.—The membership 

16 of the Commission shall include individuals 

17 with national recognition for their exper18 tise in clinical medicine, primary and pre19 ventive health care, integrative medicine, 

20 and actuarial science and health plan ben21 efit design. 

22 ‘‘(ii) INCLUSION.—The membership of 

23 the Commission shall include an expert in 

24 actuarial science and health plan benefit 

25 design, a health care provider, a patient or 


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1 consumer advocate, a representative of 

2 labor organizations representing workers, 

3 an employer, a third-party payer, a health 

4 services researcher, an individual skilled in 

5 the conduct and interpretation of the bio6 medical and health sciences, an individual 

7 with expertise in pediatric health care, and 

8 an individual with expertise in outcomes 

9 and effectiveness research and technology 

10 assessment. 

11 ‘‘(C) CHAIRMAN.—The Secretary shall des12 ignate a member of the Commission who is an 

13 expert in actuarial science and health plan ben14 efit design, at the time of appointment of such 

15 member, as Chairman. 

16 ‘‘(D) MEETINGS.—The Commission shall 

17 meet at the call of the Chairman. Advance no18 tice of such meetings shall be published in the 

19 Federal Register and the meetings shall be 

20 open to the public. 

21 ‘‘(E) ETHICAL DISCLOSURES.—The Sec22 retary shall establish a system for public disclo23 sure by members of the Commission of financial 

24 and other potential conflicts of interest relating 

25 to such members. 


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1 ‘‘(F) DEADLINE FOR APPOINTMENT.— 

2 Members of the Commission shall be appointed 

3 by not later than 45 days after the date of en4 actment of this title. 

5 ‘‘(G) TERMS OF APPOINTMENT.—The term 

6 of any appointment under subparagraph (A) to 

7 the Commission shall be for the life of the Com8 mission. 

9 ‘‘(H) COMPENSATION.—Members of the 

10 Commission shall receive no additional pay, al11 lowances, or benefits by reason of their service 

12 on the Commission. 

13 ‘‘(I) EXPENSES.—Each member of the 

14 Commission shall receive travel expenses and 

15 per diem in lieu of subsistence in accordance 

16 with sections 5702 and 5703 of title 5, United 

17 States Code. 

18 ‘‘(5) STAFF AND SUPPORT SERVICES.— 

19 ‘‘(A) EXECUTIVE DIRECTOR.— 

20 ‘‘(i) APPOINTMENT.—The Secretary 

21 shall appoint an executive director of the 

22 Commission. 

23 ‘‘(ii) COMPENSATION.—The executive 

24 director of the Commission shall be paid 


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1 the rate of basic pay for level V of the Ex2 ecutive Schedule. 

3 ‘‘(iii) STAFF.—With the approval of 

4 the Commission, the executive director may 

5 appoint such personnel as the executive di6 rector considers appropriate. 

7 ‘‘(iv) APPLICABILITY OF CIVIL SERV8 ICE LAWS.—The staff of the Commission 

9 shall be appointed without regard to the 

10 provisions of title 5, United States Code, 

11 governing appointments in the competitive 

12 service, and shall be paid without regard to 

13 the provisions of chapter 51 and sub14 chapter III of chapter 53 of such title (re15 lating to classification and General Sched16 ule pay rates). 

17 ‘‘(v) EXPERTS AND CONSULTANTS.— 

18 With the approval of the Commission, the 

19 executive director may procure temporary 

20 and intermittent services under section 

21 3109(b) of title 5, United States Code. 

22 ‘‘(6) POWERS.— 

23 ‘‘(A) COST ESTIMATES BY OFFICE OF MAN24 AGEMENT AND BUDGET AND OFFICE OF THE

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1 CARE & MEDICARE SERVICES.—The Director of 

2 the Office of Management and Budget or the 

3 Chief Actuary of the Centers for Medicare & 

4 Medicaid Services, or both, shall provide to the 

5 Commission, upon the request of the Commis6 sion, such cost estimates as the Commission de7 termines to be necessary to carry out its duties 

8 under this section. 

9 ‘‘(B) TECHNICAL ASSISTANCE.—Upon the 

10 request of the Commission, the head of a Fed11 eral agency or its representatives, including rep12 resentatives of the Office of Personnel Manage13 ment, shall provide such technical assistance to 

14 the Commission as the Commission determines 

15 to be necessary to carry out its duties under 

16 this section. 

17 ‘‘(C) OBTAINING INFORMATION.—The 

18 Commission may secure directly from any Fed19 eral agency information necessary to enable it 

20 to carry out its duties, if the information may 

21 be disclosed under section 552 of title 5, United 

22 States Code. 

23 ‘‘(D) PUBLIC INPUT.—The Commission 

24 shall adopt procedures allowing any interested 

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1 sion’s use in making reports and recommenda2 tions. 

3 ‘‘(7) REPORT.—Not later than 6 months after 

4 the date of enactment of this title, the Commission 

5 shall submit a report to the Secretary and Congress 

6 which shall contain a detailed statement of only 

7 those recommendations, findings, and conclusions of 

8 the Commission that receive the approval of at least 

9 12 members of the Commission. The Secretary shall 

10 provide for publication in the Federal Register and 

11 the posting on an appropriate Internet website of 

12 the report and recommendations of the Commission. 

13 ‘‘(8) TERMINATION.—The Commission shall 

14 terminate on the date that is 30 days after the date 

15 on which the report is submitted under subsection 

16 (7). 

17 ‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— 

18 There are authorized to be appropriated to carry out 

19 this subsection, $1,500,000. 

20 ‘‘(c) REQUIRED ELEMENTS FOR CONSIDERATION.— 

21 ‘‘(1) ESSENTIAL HEALTH CARE BENEFITS.—In 

22 establishing the essential health benefits under sub23 section (a)(1)(A), the Secretary shall— 


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1 ‘‘(A) consider the report and recommenda2 tions of the Commission established under sub3 section (b); 

4 ‘‘(B) ensure that such essential health ben5 efits reflect an appropriate balance among the 

6 categories described in such subsection, so that 

7 benefits are not unduly weighted toward any 

8 category; 

9 ‘‘(C) not make coverage decisions, deter10 mine reimbursement rates, establish incentive 

11 programs, or design benefits in ways that dis12 criminate against individuals because of their 

13 age, disability, or expected length of life; 

14 ‘‘(D) take into account the health care 

15 needs of diverse segments of the population, in16 cluding women, children, persons with disabil17 ities, and other groups; 

18 ‘‘(E) ensure that health benefits estab19 lished as essential not be subject to denial to in20 dividuals against their wishes on the basis of 

21 the individuals’ age or expected length of life or 

22 of the individuals’ present or predicted dis23 ability, degree of medical dependency, or quality 

24 of life; and 


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1 ‘‘(F) review the essential health benefits 

2 under subsection (a)(1)(A) not less than annu3 ally, and provide a report to Congress and the 

4 public that contains— 

5 ‘‘(i) an assessment of whether enroll6 ees are facing any difficulty accessing 

7 needed services for reasons of coverage or 

8 cost; 

9 ‘‘(ii) an assessment of whether the es10 sential benefits package needs to be modi11 fied or updated to account for changes in 

12 medical evidence or scientific advancement; 

13 ‘‘(iii) information on how the benefit 

14 package will be modified to address any 

15 such gaps in access or changes in the evi16 dence base; and 

17 ‘‘(iv) an assessment of the potential of 

18 additional or expanded benefits to increase 

19 costs and the interactions between the ad20 dition or expansion of benefits and reduc21 tions in existing benefits to meet actuarial 

22 limitations described in subsection (a)(2). 

23 ‘‘(2) MINIMUM QUALIFYING COVERAGE.—In es24 tablishing the criteria described in subsection 

25 (a)(1)(B), the Secretary— 


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1 ‘‘(A) shall— 

2 ‘‘(i) exclude from meeting such cri3 teria any coverage that— 

4 ‘‘(I) provides reimbursement for 

5 the treatment or mitigation of— 

6 ‘‘(aa) a single disease or 

7 condition; or 

8 ‘‘(bb) an unreasonably lim9 ited set of diseases or conditions; 

10 or 

11 ‘‘(II) has an out of pocket limit 

12 that exceeds the amount described in 

13 section 223(c)(2) of the Internal Rev14 enue Code of 1986 for the year in15 volved; and 

16 ‘‘(ii) establish such criteria (taking 

17 into account the requirements established 

18 under clause (i)) in a manner that results 

19 in the least practicable disruption of the 

20 health care marketplace, consistent with 

21 the goals and activities under this title; 

22 and 

23 ‘‘(B) may provide for the application of 

24 different criteria (except with respect to the 


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1 limitation described in subparagraph (A)(i)(II)) 

2 with respect to young adults. 

3 ‘‘(3) AFFORDABLE COVERAGE.—The Secretary 

4 shall establish a standard under which coverage is 

5 defined to be unaffordable only if the premium paid 

6 by the individual is greater than 12.5 percent of the 

7 adjusted gross income of the individual involved. Be8 ginning with calendar years after 2013, the Sec9 retary shall adjust the percentage described in this 

10 paragraph by an amount that is equal to the per11 centage increase or decrease in the medical care 

12 component of the Consumer Price Index for all 

13 urban consumers (U.S. city average) during the pre14 ceding calendar year. 

15 ‘‘SEC. 3104. ALLOWING STATE FLEXIBILITY. 

16 ‘‘(a) OPTIONAL STATE ESTABLISHMENT OF GATE17 WAY.—During the 4-year period following the date of en18 actment of this section, a State may— 

19 ‘‘(1)(A) establish a Gateway; 

20 ‘‘(B) adopt the insurance reform provisions as 

21 provided for in subtitle A of title I of the Affordable 

22 Health Choices Act (and the amendments made by 

23 such title); and 


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1 ‘‘(C) agree to make employers that are State or 

2 local governments subject to sections 162 and 163 of 

3 the Affordable Health Choices Act. 

4 ‘‘(2)(A) request that the Secretary operate (for 

5 a minimum period of 5 years) a Gateway in such 

6 State; 

7 ‘‘(B) adopt the insurance reform provisions as 

8 provided for in subtitle A of title I of the Affordable 

9 Health Choices Act (and the amendments made by 

10 such subtitle); and 

11 ‘‘(C) agree to make employers that are State or 

12 local governments subject to sections 162 and 163 of 

13 the Affordable Health Choices Act; or 

14 ‘‘(3) elect not to take the actions described in 

15 paragraph (1) or (2). 

16 ‘‘(b) ESTABLISHING STATES.— 

17 ‘‘(1) IN GENERAL.—If the Secretary determines 

18 that a State has taken the actions described in sub19 section (a)(1), any resident of that State who is an 

20 eligible individual shall be eligible for credits under 

21 section 3111 beginning on the date that is 60 days 

22 after the date of such determination. 

23 ‘‘(2) CONTINUED REVIEW.—The Secretary shall 

24 establish procedures to ensure continued review by 

25 the Secretary of the compliance of a State with the 


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1 requirements of subsection (a). If the Secretary de2 termines that a State has failed to maintain compli3 ance with such requirements, the Secretary may re4 voke the determination under paragraph (1). 

5 ‘‘(3) DEEMING.—A State that is the subject of 

6 a positive determination by the Secretary under 

7 paragraph (1) (unless such determination is revoked 

8 under paragraph (2)) shall be deemed to be an ‘es9 tablishing State’ beginning on the date that is 60 

10 days after the date of such determination. 

11 ‘‘(c) REQUEST FOR THE SECRETARY TO ESTABLISH

12 A GATEWAY.— 

13 ‘‘(1) IN GENERAL.—In the case of a State that 

14 makes the request described in subsection (a)(2), the 

15 Secretary shall determine whether the State has en16 acted and has in effect the insurance reforms pro17 vided for in subtitle A of title I of the Affordable 

18 Health Choices Act. 

19 ‘‘(2) OPERATION OF GATEWAY.— 

20 ‘‘(A) POSITIVE DETERMINATION.—If the 

21 Secretary determines that the State has enacted 

22 and has in effect the insurance reforms de23 scribed in paragraph (1), the Secretary shall es24 tablish a Gateway in such State as soon as 

25 practicable after making such determination. 


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1 ‘‘(B) NEGATIVE DETERMINATION.—If the 

2 Secretary determines that the State has not en3 acted or does not have in effect the insurance 

4 reforms described in paragraph (1), the Sec5 retary shall establish a Gateway in such State 

6 as soon as practicable after the Secretary deter7 mines that such State has enacted and has in 

8 effect such reforms. 

9 ‘‘(3) PARTICIPATING STATE.—The State shall 

10 be deemed to be a ‘participating State’ on the date 

11 on which the Gateway established by the Secretary 

12 is in effect in such State. 

13 ‘‘(4) ELIGIBILITY.—Any resident of a State de14 scribed in paragraph (3) who is an eligible individual 

15 shall be eligible for credits under section 3111 begin16 ning on the date that is 60 days after the date on 

17 which such Gateway is established in such State. 

18 ‘‘(d) FEDERAL FALLBACK IN THE CASE OF STATES

19 THAT REFUSE TO IMPROVE HEALTH CARE COVERAGE.— 

20 ‘‘(1) IN GENERAL.—Upon the expiration of the 

21 4-year period following the date of enactment of this 

22 section, in the case of a State that is not otherwise 

23 a participating State or an establishing State— 

24 ‘‘(A) the Secretary shall establish and op25 erate a Gateway in such State; 


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1 ‘‘(B) the insurance reform provisions pro2 vided for in subtitle A of title I of the Afford3 able Health Choices Act shall become effective 

4 in such State, notwithstanding any contrary 

5 provision of State law; 

6 ‘‘(C) the State shall be deemed to be a 

7 ‘participating State’; and 

8 ‘‘(D) the residents of that State who are 

9 eligible individuals shall be eligible for credits 

10 under section 3111 beginning on the date that 

11 is 60 days after the date on which such Gate12 way is established, if the State agrees to make 

13 employers that are State or local governments 

14 subject to sections 162 and 163 of the Afford15 able Health Choices Act. 

16 ‘‘(2) ELIGIBILITY OF INDIVIDUALS FOR CRED17 ITS.—With respect to a State that makes the elec18 tion described in subsection (a)(3), the residents of 

19 such State shall not be eligible for credits under sec20 tion 3111 until such State becomes a participating 

21 State under paragraph (1). 

22 ‘‘SEC. 3105. NAVIGATORS. 

23 ‘‘(a) IN GENERAL.—The Secretary shall award 

24 grants to establishing or participating States to enable 

25 such States (or the Gateways operating in such States) 


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1 to enter into agreements with private and public entities 

2 under which such entities will serve as navigators in ac3 cordance with this section. 

4 ‘‘(b) ELIGIBILITY.— 

5 ‘‘(1) IN GENERAL.—To be eligible to enter into 

6 an agreement under subsection (a), an entity shall 

7 demonstrate that the entity has existing relation8 ships with, or could readily establish relationships 

9 with, employers and employees, consumers (includ10 ing the uninsured and the underinsured), or self-em11 ployed individuals, likely to be qualified to enroll in 

12 a qualified health plan. 

13 ‘‘(2) TYPES.—Entities described in paragraph 

14 (1) may include trade, industry and professional as15 sociations, commercial fishing industry organiza16 tions, ranching and farming organizations, commu17 nity and consumer-focused nonprofit groups, cham18 bers of commerce, unions, small business develop19 ment centers, other licensed insurance agents and 

20 brokers, and other entities that the Secretary deter21 mines to be capable of carrying out the duties de22 scribed in subsection (c). 

23 ‘‘(c) DUTIES.—An entity that serves as a navigator 

24 under an agreement under subsection (a) shall— 


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1 ‘‘(1) conduct public education activities to raise 

2 awareness of the program under this title; 

3 ‘‘(2) distribute fair and impartial information 

4 concerning enrollment in qualified health plans, and 

5 the availability of credits under section 3111; 

6 ‘‘(3) facilitate enrollment in a qualified health 

7 plan; 

8 ‘‘(4) provide referrals to the appropriate State 

9 agency or agencies for any enrollee with a grievance, 

10 complaint, or question regarding their health plan, 

11 coverage, or a determination under such plan or cov12 erage; and 

13 ‘‘(5) provide information in a manner deter14 mined by the Secretary to be culturally and linguis15 tically appropriate to the needs of the population 

16 served by the Gateway. 

17 ‘‘(d) STANDARDS.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall estab19 lish standards for navigators under this section, in20 cluding provisions to ensure that any private or pub21 lic entity that is selected as a navigator is qualified, 

22 and licensed if appropriate, to engage in the navi23 gator activities described in this section and to avoid 

24 conflicts of interest. Under such standards, a navi25 gator shall not— 


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1 ‘‘(A) be a health insurance issuer; or 

2 ‘‘(B) receive any consideration directly or 

3 indirectly from any health insurance issuer in 

4 connection with the participation of any em5 ployer in the program under this title or the en6 rollment of any qualified individual or qualified 

7 employer in a qualified health plan. 

8 ‘‘(2) FAIR AND IMPARTIAL INFORMATION AND

9 SERVICES.—The Secretary, in collaboration with 

10 States, shall develop guidelines regarding the duties 

11 described in subsection (c). 

12 ‘‘SEC. 3106. COMMUNITY HEALTH INSURANCE OPTION. 

13 ‘‘(a) VOLUNTARY NATURE.— 

14 ‘‘(1) NO REQUIREMENT FOR HEALTH CARE

15 PROVIDERS TO PARTICIPATE.—Nothing in this sec16 tion shall be construed to require a health care pro17 vider to participate in a community health insurance 

18 option, or to impose any penalty for non-participa19 tion. 

20 ‘‘(2) NO REQUIREMENT FOR INDIVIDUALS TO

21 JOIN.—Nothing in this section shall be construed to 

22 require an individual to participate in a community 

23 health insurance option, or to impose any penalty for 

24 non-participation. 


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1 ‘‘(b) ESTABLISHMENT OF COMMUNITY HEALTH IN2 SURANCE OPTION.— 

3 ‘‘(1) ESTABLISHMENT.—The Secretary shall es4 tablish a community health insurance option to 

5 offer, through each Gateway established under this 

6 title, health care coverage that provides value, 

7 choice, competition, and stability of affordable, high 

8 quality coverage throughout the United States. 

9 ‘‘(2) COMMUNITY HEALTH INSURANCE OP10 TION.—In this section, the term ‘community health 

11 insurance option’ means health insurance coverage 

12 that— 

13 ‘‘(A) except as specifically provided for in 

14 this section, complies with the requirements for 

15 being a qualified health plan; 

16 ‘‘(B) provides high value for the premium 

17 charged; 

18 ‘‘(C) reduces administrative costs and pro19 motes administrative simplification for bene20 ficiaries; 

21 ‘‘(D) promotes high quality clinical care; 

22 ‘‘(E) provides high quality customer service 

23 to beneficiaries; 

24 ‘‘(F) offers a wide choice of providers; and 


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1 ‘‘(G) complies with State laws (if any), ex2 cept as otherwise provided for in this title, re3 lating to— 

4 ‘‘(i) guaranteed renewal; 

5 ‘‘(ii) rating; 

6 ‘‘(iii) preexisting conditions; 

7 ‘‘(iv) non-discrimination; 

8 ‘‘(v) quality improvement and report9 ing; 

10 ‘‘(vi) fraud and abuse; 

11 ‘‘(vii) solvency and financial require12 ments; 

13 ‘‘(viii) market conduct; 

14 ‘‘(ix) prompt payment; 

15 ‘‘(x) appeals and grievances; 

16 ‘‘(xi) privacy and confidentiality; 

17 ‘‘(xii) licensure; and 

18 ‘‘(xiii) benefit plan material or infor19 mation. 

20 ‘‘(3) ESSENTIAL HEALTH BENEFITS.— 

21 ‘‘(A) GENERAL RULE.—Except as provided 

22 in subparagraph (B), a community health in23 surance option offered under this section shall 

24 provide coverage only for the essential health 

25 benefits described in section 3103. 


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1 ‘‘(B) STATES MAY OFFER ADDITIONAL

2 BENEFITS.—A State may require that a com3 munity health insurance option offered in such 

4 State offer benefits in addition to the essential 

5 health benefits required under subparagraph 

6 (A). 

7 ‘‘(C) CREDITS.— 

8 ‘‘(i) IN GENERAL.—An individual en9 rolled in a community health insurance op10 tion under this section shall be eligible for 

11 credits under section 3111 in the same 

12 manner as an individual who is enrolled in 

13 a qualified health plan. 

14 ‘‘(ii) NO ADDITIONAL FEDERAL

15 COST.—A requirement by a State under 

16 subparagraph (B) that a community health 

17 insurance option cover benefits in addition 

18 to the essential health benefits required 

19 under subparagraph (A) shall not affect 

20 the amount of a credit provided under sec21 tion 3111 with respect to such plan. 

22 ‘‘(D) STATE MUST ASSUME COST.—A 

23 State shall make payments to or on behalf of 

24 an eligible individual to defray the cost of any 


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1 additional benefits described in subparagraph 

2 (B). 

3 ‘‘(E) ENSURING ACCESS TO ALL SERV4 ICES.—Nothing in this Act shall prohibit an in5 dividual enrolled in a community health insur6 ance option from paying out-of-pocket the full 

7 cost of any item or service not included as an 

8 essential health benefit or otherwise covered as 

9 a benefit by a health plan. Nothing in this Act 

10 shall prohibit any type of medical provider from 

11 accepting an out-of-pocket payment from an in12 dividual enrolled in a community health insur13 ance option for a service otherwise not included 

14 as an essential health benefit. 

15 ‘‘(F) PROTECTING ACCESS TO END OF

16 LIFE CARE.—A community health insurance op17 tion offered under this section shall be prohib18 ited from limiting access to end of life care. 

19 ‘‘(4) COST SHARING.—A community health in20 surance option shall offer coverage at each of the 

21 cost sharing tiers described in section 3111(a). 

22 ‘‘(5) PREMIUMS.— 

23 ‘‘(A) PREMIUMS SUFFICIENT TO COVER

24 COSTS.—The Secretary shall set premium rates 

25 in an amount sufficient to cover expected costs 


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1 (including claims and administrative costs) 

2 using methods in general use by qualified 

3 health plans. 

4 ‘‘(B) APPLICABLE RULES.—The provisions 

5 of title XXVII relating to premiums shall apply 

6 to community health insurance options under 

7 this section, including modified community rat8 ing provisions under section 2701. 

9 ‘‘(C) COLLECTION OF DATA.—The Sec10 retary shall collect data as necessary to set pre11 mium rates under subparagraph (A). 

12 ‘‘(D) CONTINGENCY MARGIN.—In estab13 lishing premium rates under subparagraph (A), 

14 the Secretary shall include an appropriate 

15 amount for a contingency margin. 

16 ‘‘(6) REIMBURSEMENT RATES.— 

17 ‘‘(A) NEGOTIATED RATES.—The Secretary 

18 shall negotiate rates for the reimbursement of 

19 health care providers for benefits covered under 

20 a community health insurance option. 

21 ‘‘(B) LIMITATION.—The rates described in 

22 subparagraph (A) shall not be higher, in aggre23 gate, than the average reimbursement rates 

24 paid by health insurance issuers offering quali25 fied health plans through the Gateway. 


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1 ‘‘(C) INNOVATION.—Subject to the limits 

2 contained in subparagraph (A), a State Advi3 sory Council established or designated under 

4 subsection (d) may develop or encourage the 

5 use of innovative payment policies that promote 

6 quality, efficiency and savings to consumers. 

7 ‘‘(D) PHYSICIAN NEGOTIATED RATES.— 

8 Nothing in this paragraph shall prohibit the ap9 plication of a State law that permits physicians 

10 to jointly negotiate with health plans. In such 

11 State, physicians may jointly negotiate with a 

12 community health insurance option concerning 

13 rates paid by the option. 

14 ‘‘(7) SOLVENCY AND CONSUMER PROTEC15 TION.— 

16 ‘‘(A) SOLVENCY.—The Secretary shall es17 tablish a Federal solvency standard to be ap18 plied with respect to a community health insur19 ance option. A community health insurance op20 tion shall also be subject to the solvency stand21 ard of each State in which such community 

22 health insurance option is offered. 

23 ‘‘(B) MINIMUM REQUIRED.—In estab24 lishing the standard described under subpara25 graph (A), the Secretary shall require a reserve 


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1 fund that shall be equal to at least the dollar 

2 value of the incurred but not reported claims of 

3 a community health insurance option. 

4 ‘‘(C) CONSUMER PROTECTIONS.—The con5 sumer protection laws of a State shall apply to 

6 a community health insurance option. 

7 ‘‘(8) REQUIREMENTS ESTABLISHED IN PART8 NERSHIP WITH INSURANCE COMMISSIONERS.— 

9 ‘‘(A) IN GENERAL.—The Secretary, in col10 laboration with the National Association of In11 surance Commissioners (in this paragraph re12 ferred to as the ‘NAIC’), may promulgate regu13 lations to establish additional requirements for 

14 a community health insurance option. 

15 ‘‘(B) APPLICABILITY.—Any requirement 

16 promulgated under subparagraph (A) shall be 

17 applicable to such option beginning 90 days 

18 after the date on which the regulation involved 

19 becomes final. 

20 ‘‘(9) OMBUDSMAN.—In establishing community 

21 health insurance options, the Secretary shall estab22 lish an ombudsman or similar mechanism to provide 

23 assistance to consumers with respect to disputes, 

24 grievances, or appeals. 

25 ‘‘(c) START-UP FUND.— 


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1 ‘‘(1) ESTABLISHMENT OF FUND.— 

2 ‘‘(A) IN GENERAL.—There is established in 

3 the Treasury of the United States a trust fund 

4 to be known as the ‘Health Benefit Plan Start5 Up Fund’ (referred to in this section as the 

6 ‘Start-Up Fund’), that shall consist of such 

7 amounts as may be appropriated or credited to 

8 the Start-Up Fund as provided for in this sub9 section to provide loans for the initial oper10 ations of a community health insurance option. 

11 Such amounts shall remain available until ex12 pended. 

13 ‘‘(B) FUNDING.—There is hereby appro14 priated to the Start-Up Fund, out of any mon15 eys in the Treasury not otherwise appropriated 

16 an amount requested by the Secretary of 

17 Health and Human Services as necessary to— 

18 ‘‘(i) pay the start-up costs associated 

19 with the initial operations of a community 

20 health insurance option; 

21 ‘‘(ii) pay the costs of making pay22 ments on claims submitted during the pe23 riod that is not more than 90 days from 

24 the date on which such option is offered; 

25 and 


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1 ‘‘(iii) make payments under para2 graph (3). 

3 ‘‘(2) USE OF START-UP FUND.—The Secretary 

4 shall use amounts contained in the Start-Up Fund 

5 to make payments (subject to the repayment re6 quirements in paragraph (5)) for the purposes de7 scribed in paragraph (1)(B). 

8 ‘‘(3) RISK CORRIDOR PAYMENTS.— 

9 ‘‘(A) IN GENERAL.—In any case in which 

10 the Secretary has entered into a contract with 

11 a contracting administrator, the Secretary shall 

12 use amounts contained in the Start-Up Fund to 

13 make risk corridor payments to such adminis14 trator during the 2-year period beginning on 

15 the date on which such administrator enters 

16 into a contract under subsection (e). Such pay17 ments shall be based on the risk corridors in ef18 fect during fiscal years 2006 and 2007 for 

19 making payments under section 1860D-15(e) of 

20 the Social Security Act. 

21 ‘‘(B) SUBSEQUENT YEAR.—In years after 

22 the expiration of the period referred to in sub23 paragraph (A), the Secretary may extend or in24 crease the risk corridors and payments provided 

25 for under subparagraph (A). 


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1 ‘‘(C) AMOUNT USED TO REDUCE COSTS.— 

2 The Secretary shall deposit any payments re3 ceived from a contracting administrator under 

4 subparagraph (A) into the Start-Up Fund. 

5 ‘‘(4) PASS THROUGH OF REBATES.—The Sec6 retary may establish procedures for reducing the 

7 amount of payments to a contracting administrator 

8 to take into account any rebates or price conces9 sions. 

10 ‘‘(5) REPAYMENT.— 

11 ‘‘(A) IN GENERAL.—A community health 

12 insurance option shall be required to repay the 

13 Secretary of the Treasury (on such terms as the 

14 Secretary may require) for any payments made 

15 under paragraph (1)(B) by the date that is not 

16 later than 10 years after the date on which the 

17 payment is made. The Secretary may require 

18 the payment of interest with respect to such re19 payments at rates that do not exceed the mar20 ket interest rate (as determined by the Sec21 retary). 

22 ‘‘(B) SANCTIONS IN CASE OF FOR-PROFIT

23 CONVERSION.—In any case in which the Sec24 retary enters into a contract with a qualified 

25 entity for the offering of a community health 


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1 insurance option and such entity is determined 

2 to be a for-profit entity by the Secretary, such 

3 entity shall be— 

4 ‘‘(i) immediately liable to the Sec5 retary for any payments received by such 

6 entity from the Start-Up Fund; and 

7 ‘‘(ii) permanently ineligible to offer a 

8 qualified health plan. 

9 ‘‘(d) STATE ADVISORY COUNCIL.— 

10 ‘‘(1) ESTABLISHMENT.—A State shall establish 

11 or designate a public or non-profit private entity to 

12 serve as the State Advisory Council to provide rec13 ommendations to the Secretary on the operations 

14 and policies of a community health insurance option 

15 in the State. Such Council shall provide rec16 ommendations on at least the following: 

17 ‘‘(A) policies and procedures to integrate 

18 quality improvement and cost containment 

19 mechanisms into the health care delivery sys20 tem; 

21 ‘‘(B) mechanisms to facilitate public 

22 awareness of the availability of a community 

23 health insurance option; and 

24 ‘‘(C) alternative payment structures under 

25 a community health insurance option for health 


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1 care providers that encourage quality improve2 ment and cost control. 

3 ‘‘(2) MEMBERS.—The members of the State 

4 Advisory Council shall be representatives of the pub5 lic and shall include educated health care consumers 

6 and providers. 

7 ‘‘(3) APPLICABILITY OF RECOMMENDATIONS.— 

8 The Secretary may apply the recommendations of a 

9 State Advisory Council to a community health insur10 ance option that State, in any other State, or in all 

11 States. 

12 ‘‘(e) AUTHORITY TO CONTRACT; TERMS OF CON13 TRACT.— 

14 ‘‘(1) AUTHORITY.— 

15 ‘‘(A) IN GENERAL.—The Secretary may 

16 enter into a contract or contracts with one or 

17 more qualified entities for the purpose of per18 forming administrative functions (including 

19 functions described in subsection (a)(4) of sec20 tion 1874A of the Social Security Act) with re21 spect to a community health insurance option in 

22 the same manner as the Secretary may enter 

23 into contracts under subsection (a)(1) of such 

24 section. The Secretary shall have the same au25 thority with respect to a community health inVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00122 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 surance option under this section as the Sec2 retary has under subsections (a)(1) and (b) of 

3 section 1874A of the Social Security Act with 

4 respect to title XVIII of such Act. 

5 ‘‘(B) REQUIREMENTS APPLY.—If the Sec6 retary enters into a contract with a qualified 

7 entity to offer a community health insurance 

8 option, under such contract such entity— 

9 ‘‘(i) shall meet the criteria established 

10 under paragraph (2); and 

11 ‘‘(ii) shall receive an administrative 

12 fee under paragraph (7). 

13 ‘‘(C) LIMITATION.—Contracts under this 

14 subsection shall not involve the transfer of in15 surance risk to the contracting administrator. 

16 ‘‘(D) REFERENCE.—An entity with which 

17 the Secretary has entered into a contract under 

18 this paragraph shall be referred to as a ‘con19 tracting administrator’. 

20 ‘‘(2) QUALIFIED ENTITY.—To be qualified to be 

21 selected by the Secretary to offer a community 

22 health insurance option, an entity shall— 

23 ‘‘(A) meet the criteria established under 

24 section 1874A(a)(2) of the Social Security Act; 


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1 ‘‘(B) be a nonprofit entity for purposes of 

2 offering such option; 

3 ‘‘(C) meet the solvency standards applica4 ble under subsection (b)(7); 

5 ‘‘(D) be eligible to offer health insurance 

6 or health benefits coverage; 

7 ‘‘(E) meet quality standards specified by 

8 the Secretary; 

9 ‘‘(F) have in place effective procedures to 

10 control fraud, abuse, and waste; and 

11 ‘‘(G) meet such other requirements as the 

12 Secretary may impose. 

13 ‘‘Procedures described under subparagraph (F) shall 

14 include the implementation of procedures to use ben15 eficiary identifiers to identify individuals entitled to 

16 benefits so that such an individual’s social security 

17 account number is not used, and shall also include 

18 procedures for the use of technology (including 

19 front-end, prepayment intelligent data-matching 

20 technology similar to that used by hedge funds, in21 vestment funds, and banks) to provide real-time 

22 data analysis of claims for payment under this title 

23 to identify and investigate unusual billing or order 

24 practices under this title that could indicate fraud or 

25 abuse. 


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1 ‘‘(3) TERM.—A contract provided for under 

2 paragraph (1) shall be for a term of at least 5 years 

3 but not more than 10 years, as determined by the 

4 Secretary. At the end of each such term, the Sec5 retary shall conduct a competitive bidding process 

6 for the purposes of renewing existing contracts or 

7 selecting new qualified entities with which to enter 

8 into contracts under such paragraph. 

9 ‘‘(4) LIMITATION.—A contract may not be re10 newed under this subsection unless the Secretary de11 termines that the contracting administrator has met 

12 performance requirements established by the Sec13 retary in the areas described in paragraph (7)(B). 

14 ‘‘(5) AUDITS.—The Inspector General shall 

15 conduct periodic audits with respect to contracting 

16 administrators under this subsection to ensure that 

17 the administrator involved is in compliance with this 

18 section. 

19 ‘‘(6) REVOCATION.—A contract awarded under 

20 this subsection shall be revoked by the Secretary or 

21 the Inspector General only after notice to the con22 tracting administrator involved and an opportunity 

23 for a hearing. The Secretary may revoke such con24 tract if the Secretary determines that such adminis25 trator has engaged in fraud, deception, waste, abuse 


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1 of power, negligence, mismanagement of taxpayer 

2 dollars, or gross mismanagement. An entity that has 

3 had a contract revoked under this paragraph shall 

4 not be qualified to enter into a subsequent contract 

5 under this subsection. 

6 ‘‘(7) FEE FOR ADMINISTRATION.— 

7 ‘‘(A) IN GENERAL.—The Secretary shall 

8 pay the contracting administrator a fee for the 

9 management, administration, and delivery of 

10 the benefits under this section. 

11 ‘‘(B) REQUIREMENT FOR HIGH QUALITY

12 ADMINISTRATION.—The Secretary may increase 

13 the fee described in subparagraph (A) by not 

14 more than 10 percent, or reduce the fee de15 scribed in subparagraph (A) by not more than 

16 50 percent, based on the extent to which the 

17 contracting administrator, in the determination 

18 of the Secretary, meets performance require19 ments established by the Secretary, in at least 

20 the following areas: 

21 ‘‘(i) Maintaining low premium costs 

22 and low cost sharing requirements, pro23 vided that such requirements are con24 sistent with section 3111(a). 


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1 ‘‘(ii) Reducing administrative costs 

2 and promoting administrative simplifica3 tion for beneficiaries. 

4 ‘‘(iii) Promoting high quality clinical 

5 care. 

6 ‘‘(iv) Providing high quality customer 

7 service to beneficiaries. 

8 ‘‘(C) NON-RENEWAL.—The Secretary may 

9 not renew a contract to offer a community 

10 health insurance option under this section with 

11 any contracting entity that has been assessed 

12 more than one reduction under subparagraph 

13 (B) during the contract period. 

14 ‘‘(8) LIMITATION.—Notwithstanding the terms 

15 of a contract under this subsection, the Secretary 

16 shall negotiate the reimbursement rates for purposes 

17 of subsection (b)(6). 

18 ‘‘(f) REPORT BY HHS AND INSOLVENCY WARN19 INGS.— 

20 ‘‘(1) IN GENERAL.—On an annual basis, the 

21 Secretary shall conduct a study on the solvency of 

22 a community health insurance option and submit to 

23 Congress a report describing the results of such 

24 study. 


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1 ‘‘(2) RESULT.—If, in any year, the result of the 

2 study under paragraph (1) is that a community 

3 health insurance option is insolvent, such result shall 

4 be treated as a community health insurance option 

5 solvency warning. 

6 ‘‘(3) SUBMISSION OF PLAN AND PROCEDURE.— 

7 ‘‘(A) IN GENERAL.—If there is a commu8 nity health insurance option solvency warning 

9 under paragraph (2) made in a year, the Presi10 dent shall submit to Congress, within the 15- 

11 day period beginning on the date of the budget 

12 submission to Congress under section 1105(a) 

13 of title 31, United States Code, for the suc14 ceeding year, proposed legislation to respond to 

15 such warning. 

16 ‘‘(B) PROCEDURE.—In the case of a legis17 lative proposal submitted by the President pur18 suant to subparagraph (A), such proposal shall 

19 be considered by Congress using the same pro20 cedures described under sections 803 and 804 

21 of the Medicare Prescription Drug, Improve22 ment, and Modernization Act of 2003 that shall 

23 be used for a medicare funding warning. 

24 ‘‘(g) MARKETING PARITY.—In a facility controlled by 

25 the Federal Government, or by a State, where marketing 


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1 or promotional materials related to a community health 

2 insurance option are made available to the public, making 

3 available marketing or promotional materials relating to 

4 private health insurance plans shall not be prohibited. 

5 Such materials include informational pamphlets, guide6 books, enrollment forms, or other materials determined 

7 reasonable for display. 

8 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

9 is authorized to be appropriated, such sums as may be 

10 necessary to carry out this section. 

11 ‘‘SEC. 3107. APPLICATION OF SAME LAWS TO PRIVATE 

12 PLANS AND THE COMMUNITY HEALTH INSUR13 ANCE OPTION. 

14 ‘‘(a) IN GENERAL.—Notwithstanding any other pro15 vision of law, any health insurance coverage offered by a 

16 private health insurance issuer shall not be subject to any 

17 Federal or State law described in subsection (b) if a com18 munity health insurance option under section 3106 is not 

19 subject to such law. 

20 ‘‘(b) LAWS DESCRIBED.—The Federal and State 

21 laws described in this subsection are those Federal and 

22 State laws relating to— 

23 ‘‘(1) guaranteed renewal; 

24 ‘‘(2) rating; 

25 ‘‘(3) preexisting conditions; 


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1 ‘‘(4) non-discrimination; 

2 ‘‘(5) quality improvement and reporting; 

3 ‘‘(6) fraud and abuse; 

4 ‘‘(7) solvency and financial requirements; 

5 ‘‘(8) market conduct; 

6 ‘‘(9) prompt payment; 

7 ‘‘(10) appeals and grievances; 

8 ‘‘(11) privacy and confidentiality; 

9 ‘‘(12) licensure; and 

10 ‘‘(13) benefit plan material or information. 

11 ‘‘SEC. 3108. PARTICIPATION OF PROFESSIONALS ON CER12 TAIN HEALTH-RELATED COMMISSIONS. 

13 ‘‘The membership of any council, committee, or other 

14 advisory body which the Secretary uses to inform official 

15 decision-making related to coverage of, or payment for, 

16 medical procedures, conditions, or care, shall have as its 

17 participants professionals who hold medical degrees from 

18 accredited American universities or colleges and have ac19 tive clinical practice. Such advisory entities shall be com20 posed of not less than one-third of such professionals. 

21 ‘‘SEC. 3109. HEALTH INSURANCE CONSUMER ASSISTANCE 

22 GRANTS. 

23 ‘‘(a) IN GENERAL.—The Secretary shall award 

24 grants to establishing or participating States to enable 

25 such States (or the Gateways operating in such States) 


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1 to establish, expand, or provide support for offices of 

2 health insurance consumer assistance. 

3 ‘‘(b) ELIGIBILITY.— 

4 ‘‘(1) IN GENERAL.—To be eligible to receive a 

5 grant, a State shall designate an office of health in6 surance consumer assistance that, directly or in co7 ordination with State health insurance regulators 

8 and consumer assistance organizations, receives and 

9 responds to inquiries and complaints concerning 

10 health insurance coverage with respect to Federal 

11 health insurance requirements and under State law. 

12 ‘‘(2) CRITERIA.—A State that receives a grant 

13 under this section shall comply with criteria estab14 lished by the Secretary for carrying out activities 

15 under such grant. 

16 ‘‘(c) DUTIES.—The State-designated office of health 

17 insurance consumer assistance shall— 

18 ‘‘(1) assist with the filing of complaints and ap19 peals, including filing appeals with a qualified health 

20 plan’s internal appeal or grievance process and pro21 viding information about the external appeal process; 

22 ‘‘(2) track consumer complaints, quantify such 

23 complaints, and regularly report such complaints to 

24 the State Gateway or the Secretary, as necessary; 


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1 ‘‘(3) educate consumers on their rights and re2 sponsibilities with respect to qualified health plans; 

3 and 

4 ‘‘(4) assist consumers with enrollment in a 

5 qualified health plan by providing information, refer6 ral, and assistance, in collaboration with navigators 

7 under section 3105. 

8 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

9 is authorized to be appropriated to carry out this section, 

10 $20,000,000 for fiscal year 2010, and such sums as may 

11 be necessary for each fiscal year thereafter.’’. 

12 SEC. 143. FREEDOM NOT TO PARTICIPATE IN FEDERAL 

13 HEALTH INSURANCE PROGRAMS. 

14 (a) REQUIREMENT.—Notwithstanding any other pro15 vision of law, on the date of enactment of this Act, all 

16 Members of Congress and congressional staff shall enroll 

17 in a Federal health insurance program— 

18 (1) created under this Act (or an amendment 

19 made by this Act); or 

20 (2) offered through a Gateway established 

21 under this Act (or an amendment made by this Act). 

22 (b) DEFINITIONS.—In this section: 

23 (1) MEMBER OF CONGRESS.—The term ‘‘Mem24 ber of Congress’’ means any member of the House 

25 of Representatives or the Senate. 


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1 (2) CONGRESSIONAL STAFF.—The term ‘‘con2 gressional staff’’ means all full-time and part-time 

3 employees employed by the official office of a Mem4 ber of Congress, whether in Washington, DC or out5 side of Washington, DC. 

6 Subtitle C—Affordable Coverage 

7 for All Americans 

8 SEC. 151. SUPPORT FOR AFFORDABLE HEALTH COVERAGE. 

9 (a) IN GENERAL.—Title XXXI of the Public Health 

10 Service Act, as added by section 142(a), is amended by 

11 inserting after subtitle A the following: 

12 ‘‘Subtitle B—Making Coverage 

13 Affordable 

14 ‘‘SEC. 3111. SUPPORT FOR AFFORDABLE HEALTH COV15 ERAGE. 

16 ‘‘(a) COST SHARING FOR A BASIC PLAN.— 

17 ‘‘(1) BASIC PLAN.—The Secretary shall estab18 lish at least the following tiers of cost sharing for el19 igible individuals: 

20 ‘‘(A) A tier for a basic plan in which— 

21 ‘‘(i) a qualified health plan shall, on 

22 average, provide reimbursement for 76 per23 cent of the total allowed costs of the ben24 efit provided; and 


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1 ‘‘(ii) the out of pocket limitation for 

2 the plan shall not be greater than the out 

3 of pocket limitation applicable under sec4 tion 223(c)(2) of the Internal Revenue 

5 Code of 1986. 

6 ‘‘(B) A tier in which— 

7 ‘‘(i) the average reimbursement per8 centage is equal to the reimbursement per9 centage of the basic plan increased by 8 

10 percentage points; and 

11 ‘‘(ii) the dollar value of the out of 

12 pocket limitation shall not be greater than 

13 50 percent of the dollar value of the out of 

14 pocket limitation of the basic plan. 

15 ‘‘(C) A tier in which— 

16 ‘‘(i) the average reimbursement per17 centage is equal to the reimbursement per18 centage of the basic plan increased by 17 

19 percentage points; and 

20 ‘‘(ii) the dollar value of the out of 

21 pocket limitation shall not be greater than 

22 20 percent of the dollar value of the out of 

23 pocket limitation of the basic plan. 

24 ‘‘(2) OUT OF POCKET.—For purposes of this 

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1 penditures for covered qualified medical expenses (as 

2 provided for with respect to high deductible health 

3 plans under section 223(d)(2) of the Internal Rev4 enue Code of 1986). 

5 ‘‘(b) PAYMENT OF CREDITS.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall, with 

7 respect to an eligible individual (as defined in section 

8 3116(a)(1)) and on behalf of such individual, pay a 

9 premium credit to the Gateway through which the 

10 individual is enrolled in the qualified health plan in11 volved. Such Gateway shall remit an amount equal 

12 to such credit to the qualified health plan in which 

13 such individual is enrolled. 

14 ‘‘(2) AMOUNT.— 

15 ‘‘(A) IN GENERAL.—Subject to the index16 ing provision described in paragraph (6), and 

17 the limitation described in paragraph (4), the 

18 amount of an annual credit with respect to an 

19 eligible individual under paragraph (1) shall be 

20 an amount determined by the Secretary so that 

21 the eligible individual involved is not required to 

22 pay in the case of an individual with an ad23 justed gross income equal to 400 percent of the 

24 poverty line for a family of the size involved, an 


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1 amount that exceeds 12.5 percent of such indi2 vidual’s income for the year involved. 

3 ‘‘(B) REDUCTIONS BASED ON INCOME.— 

4 The amount that an eligible individual is re5 quired to pay under subparagraph (A) shall be 

6 ratably reduced to 1 percent of income in the 

7 case of an eligible individual with an adjusted 

8 gross income equal to 150 percent of the pov9 erty line for a family of the size involved for the 

10 year. 

11 ‘‘(3) SIMPLIFIED SCHEDULE.—The Secretary 

12 may establish a schedule of premium credits under 

13 this subsection in dollar amounts to simplify the ad14 ministration of this section so long as any such 

15 schedule does not significantly change the value of 

16 the premium credits described in paragraph (2). 

17 ‘‘(4) LIMITATION OF CREDITS.— 

18 ‘‘(A) IN GENERAL.—A credit under para19 graph (1) may not exceed the lesser of the 

20 amount of the reference premium for the indi21 vidual involved or the premium of the qualified 

22 health plan in which such individual is enrolled. 

23 ‘‘(B) REFERENCE PREMIUM.—In this sec24 tion, the term ‘reference premium’ means— 


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1 ‘‘(i) with respect to an individual en2 rolling in coverage whose adjusted gross 

3 income does not exceed 200 percent of the 

4 poverty line for a family of the size in5 volved for the year, the weighted average 

6 annual premium of the 3 lowest cost quali7 fied health plans that— 

8 ‘‘(I) meet the criteria for cost 

9 sharing and out of pocket limits de10 scribed in subsection (a)(1)(C); and 

11 ‘‘(II) are offered in the commu12 nity rating area in which the indi13 vidual resides; 

14 ‘‘(ii) with respect to an individual en15 rolling in coverage whose adjusted gross 

16 income exceeds 200, but does not exceed 

17 300, percent of the poverty line for a fam18 ily of the size involved for the year, the 

19 weighted average annual premium of the 3 

20 lowest cost qualified health plans that— 

21 ‘‘(I) meet the criteria for cost 

22 sharing and out of pocket limits de23 scribed in subsection (a)(1)(B); and 


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1 ‘‘(II) are offered in the commu2 nity rating area in which the indi3 vidual resides; and 

4 ‘‘(iii) with respect to an individual en5 rolling in coverage whose adjusted gross 

6 income exceeds 300, but does not exceed 

7 400, percent of the poverty line for a fam8 ily of the size involved for the year, the 

9 weighted average annual premium of the 3 

10 lowest cost qualified health plans that— 

11 ‘‘(I) meet the criteria for cost 

12 sharing and out of pocket limits de13 scribed in subsection (a)(1)(A); and 

14 ‘‘(II) are offered in the commu15 nity rating area in which the indi16 vidual resides. 

17 ‘‘(C) INDIVIDUALS ALLOWED TO ENROLL

18 IN ANY PLAN.—Nothing in this section shall be 

19 construed to prohibit a qualified individual from 

20 enrolling in any qualified health plan. 

21 ‘‘(D) LIMITATION.—In determining the 3 

22 lowest cost health plans for purposes of this 

23 paragraph, the community health insurance op24 tion shall not be considered. 

25 ‘‘(5) METHOD OF CALCULATION.— 


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1 ‘‘(A) CALCULATION OF CREDIT BASED ON

2 ESSENTIAL HEALTH CARE BENEFITS.—In the 

3 case of a qualified health plan that provides re4 imbursement for benefits that are not included 

5 in the essential health benefits established by 

6 the Secretary under section 3103(a)(1)(A), the 

7 reference premium shall be determined for pur8 poses of paragraph (2) without regard to such 

9 reimbursement. 

10 ‘‘(B) RISK ADJUSTMENT.—The reference 

11 premium shall be adjusted to account for pre12 mium differences based on age, family size, and 

13 geographic variation. 

14 ‘‘(C) RULE IN CASE OF FEWER PLANS.— 

15 In any case in which there are less than 3 

16 qualified health plans offered in the community 

17 rating area in which the individual resides, the 

18 determinations made under paragraph (2) shall 

19 be based on the number of such qualified plans 

20 that are actually offered in the area. 

21 ‘‘(6) INDEXING.—Beginning with calendar 

22 years after 2013, the percentages described in para23 graph (2) that specify the portion of the reference 

24 premium that an individual or family is responsible 

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1 age that is equal to the percentage increase or de2 crease in the medical care component of the Con3 sumer Price Index for all urban consumers (U.S. 

4 city average) during the preceding calendar year. 

5 ‘‘(c) STATE FLEXIBILITY.—A State may make pay6 ments to or on behalf of an eligible individual that are 

7 greater than the amounts required under this section. 

8 ‘‘(d) ELIGIBILITY DETERMINATIONS.— 

9 ‘‘(1) RULE FOR ELIGIBILITY DETERMINA10 TIONS.—The Secretary shall, by regulation, establish 

11 rules and procedures for— 

12 ‘‘(A) the submission of applications during 

13 the fourth quarter of the calendar year involved 

14 for payments under this section, including the 

15 electronic submission of documents necessary 

16 for application and enrollment; 

17 ‘‘(B) making determinations with respect 

18 to the eligibility of individuals submitting appli19 cations under subparagraph (A) for payments 

20 under this section and informing individuals of 

21 such determinations, including verifying income 

22 through the use of data contained in the tax re23 turns of applicants for such credits; 

24 ‘‘(C) making determinations of adjusted 

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1 plicant was not required to file a tax return for 

2 the taxable year involved; 

3 ‘‘(D) resolving appeals of such determina4 tions; 

5 ‘‘(E) redetermining eligibility on a periodic 

6 basis; and 

7 ‘‘(F) making payments under this section. 

8 ‘‘(2) DETERMINATION OF ELIGIBILITY.—For 

9 purposes of paragraph (1), the Secretary shall estab10 lish rules that permit eligibility to be determined 

11 based on— 

12 ‘‘(A) the applicant’s adjusted gross income 

13 for the second preceding taxable year; or 

14 ‘‘(B) in the case of an individual who is 

15 seeking payment under this section based on 

16 claiming a significant decrease in adjusted 

17 gross income— 

18 ‘‘(i) the applicant’s adjusted gross in19 come for the most recent period otherwise 

20 practicable; or 

21 ‘‘(ii) the applicant’s declaration of es22 timated annual adjusted gross income for 

23 the year involved. 

24 ‘‘(3) DETERMINING ELIGIBILITY.— 

25 ‘‘(A) AUTHORITY OF THE SECRETARY.— 


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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall have the authority to make deter3 minations (including redeterminations) 

4 with respect to the eligibility of individuals 

5 submitting applications for credits under 

6 this section. The Secretary shall verify, 

7 through the Internal Revenue Service or 

8 using the income and eligibility verification 

9 system utilized for purposes of the Med10 icaid program under section 1137 of the 

11 Social Security Act, the income data re12 ceived from individuals submitting applica13 tions for credits under this section. 

14 ‘‘(ii) AUTHORITY TO USE TAX RE15 TURNS.—To be eligible to receive a credit 

16 under this section, an individual shall— 

17 ‘‘(I) authorize the disclosure of 

18 the tax return information of the indi19 vidual as provided for in section 

20 6103(l)(21) of the Internal Revenue 

21 Code; or 

22 ‘‘(II) with respect to individuals 

23 who do not file a tax return for the 

24 year involved— 


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1 ‘‘(aa) provide satisfactory 

2 documentation of adjusted gross 

3 income, as determined by the 

4 Secretary, which may include a 

5 prior year Federal income tax re6 turn; and 

7 ‘‘(bb) authorize the disclo8 sure to the Secretary of such in9 formation as may be required 

10 from the Internal Revenue Serv11 ice to verify that such individual 

12 has not filed a tax return for the 

13 year involved. 

14 ‘‘(iii) STRINGENCY.—The verification 

15 requirements with respect to individuals 

16 described in clause (ii)(II) shall be at least 

17 as stringent as those required under sec18 tion 1137 of the Social Security Act. 

19 ‘‘(B) DELEGATION OF AUTHORITY.—Ex20 cept under the conditions described in subpara21 graph (D), the Secretary shall delegate to a 

22 Gateway (and, upon request from such State or 

23 States, to the State or States in which such 

24 Gateway operates) the authority to carry out 

25 the activities described in subparagraph (A). 


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1 The Gateway may consult with the Internal 

2 Revenue Service to verify income data received 

3 from individuals submitting applications for 

4 credits under this section. 

5 ‘‘(C) REQUIREMENT FOR CONSISTENCY.— 

6 A Gateway (and, as applicable, the State or 

7 States in which such Gateway operates) shall 

8 carry out the activities described in subpara9 graph (B) in a manner that is consistent with 

10 the regulations promulgated under paragraph 

11 (1). 

12 ‘‘(D) REVOCATION OF AUTHORITY.—If the 

13 Secretary determines that a Gateway (or the 

14 State or States in which such Gateway oper15 ates) is carrying out the activities described in 

16 subparagraph (A) in a manner that is substan17 tially inconsistent with the regulations promul18 gated under paragraph (1), the Secretary may, 

19 after notice and opportunity for a hearing, re20 voke the delegation of authority under subpara21 graph (A). If the Secretary revokes the delega22 tion of authority, the references to a Gateway 

23 in subparagraph (E) and (F) shall be deemed 

24 to be references to the Secretary. 


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1 ‘‘(E) REQUIREMENT TO REPORT CHANGE

2 IN STATUS.— 

3 ‘‘(i) IN GENERAL.—An individual who 

4 has been determined to be eligible for cred5 its under this section shall notify the Gate6 way of any changes that may affect such 

7 eligibility in a manner specified by the Sec8 retary. 

9 ‘‘(ii) REDETERMINATION.—If the 

10 Gateway receives a notice from an indi11 vidual under clause (i), the Gateway shall 

12 promptly redetermine the individual’s eligi13 bility for payments. 

14 ‘‘(F) TERMINATION OF PAYMENTS.—The 

15 Gateway shall terminate payments on behalf of 

16 an individual (after providing notice to the indi17 vidual) if— 

18 ‘‘(i) the individual fails to provide in19 formation for purposes of subparagraph 

20 (E)(i) on a timely basis; or 

21 ‘‘(ii) the Gateway determines that the 

22 individual is no longer eligible for such 

23 payments. 

24 ‘‘(G) TERRITORIAL TAX AUTHORITIES.— 

25 With respect to determinations of eligibility for, 


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1 or payment of, credits under this section that 

2 require the use of information maintained by a 

3 tax authority of a United States territory, the 

4 Secretary shall make such determination in co5 ordination with such authority under rules and 

6 procedures that are similar to the rules and 

7 procedures applied to determinations made 

8 where such information is obtained from the In9 ternal Revenue Service. 

10 ‘‘(4) APPLICATION.— 

11 ‘‘(A) METHODS.—The process established 

12 under paragraph (1)(A) shall permit applica13 tions in person, by mail, telephone, or the Inter14 net. 

15 ‘‘(B) FORM AND CONTENTS.—An applica16 tion under paragraph (1)(A) shall be in such 

17 form and manner as specified by the Secretary, 

18 and may require documentation. 

19 ‘‘(C) SUBMISSION.—An application under 

20 paragraph (1)(A) may be submitted to the 

21 Gateway, or to a State agency for a determina22 tion under this section. 

23 ‘‘(D) ASSISTANCE.—A Gateway, or a State 

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1 uals in the filing of applications under para2 graph (1)(A). 

3 ‘‘(5) RECONCILIATION.— 

4 ‘‘(A) FILING OF STATEMENT.—In the case 

5 of an individual who has received payments 

6 under this section for a year and who is claim7 ing a significant decrease (as determined by the 

8 Secretary) in adjusted gross income from such 

9 year, such individual shall file with the Sec10 retary an income reconciliation statement, at 

11 such time, in such manner, and containing such 

12 information as the Secretary may require. 

13 ‘‘(B) RECONCILIATION.— 

14 ‘‘(i) IN GENERAL.—Based on and 

15 using the adjusted gross income reported 

16 in the statement filed by an individual 

17 under subparagraph (A), the Secretary 

18 shall compute the amount of payments 

19 that should have been provided on behalf 

20 of the individual for the year involved. 

21 ‘‘(ii) OVERPAYMENT OF PAYMENTS.— 

22 ‘‘(I) IN GENERAL.—Subject to 

23 the limitation in subclause (II), if the 

24 amount of payments provided on be25 half of an individual for a year under 


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1 this section was significantly greater 

2 (as determined by the Secretary) than 

3 the amount computed under clause 

4 (i), the individual shall be liable to the 

5 Secretary for such excess amount. 

6 The Secretary may establish methods 

7 under which such liability may be as8 sessed through a reduction in the 

9 amount of any credit otherwise appli10 cable under this section with respect 

11 to such individual. 

12 ‘‘(II) LIMITATION.—With respect 

13 to any individual described in sub14 clause (I) who had a verified adjusted 

15 gross income that did not exceed 400 

16 percent of the poverty line for a fam17 ily of the size involved for such year, 

18 the amount of any repayment under 

19 such subclause (I) shall not exceed— 

20 ‘‘(aa) $250 for an individual 

21 who filed an individual tax return 

22 for such year; or 

23 ‘‘(bb) $400 for an individual 

24 who filed a joint tax return for 

25 such year. 


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1 Any such individual with a adjusted 

2 gross income that exceeds 400 percent 

3 of the poverty line for a family of the 

4 size involved for such year shall repay 

5 the entire amount so received. 

6 ‘‘(iii) UNDERPAYMENT OF PAY7 MENTS.—If the amount of payments pro8 vided to an individual for a year under this 

9 section was less than the amount computed 

10 under clause (i), the Secretary shall pay to 

11 the individual the amount of such deficit. 

12 The Secretary may establish methods 

13 under which such payments may be pro14 vided through an increase in the amount of 

15 any credit otherwise applicable under this 

16 section with respect to such individual. 

17 ‘‘(iv) COORDINATION WITH IRS.—The 

18 Secretary shall coordinate with the Sec19 retary of the Treasury to develop proce20 dures to enable the Internal Revenue Serv21 ice to administer this subparagraph with 

22 respect to the collection of overpayments. 

23 ‘‘(C) FAILURE TO FILE.—In the case of an 

24 individual who fails to file a statement for a 

25 year as required under subparagraph (A), the 


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1 individual shall not be eligible for further pay2 ments until such statement is filed. The Sec3 retary shall waive the application of this sub4 paragraph if the individual establishes, to the 

5 satisfaction of the Secretary, good cause for the 

6 failure to file the statement on a timely basis. 

7 ‘‘(D) DETERMINATIONS.—The Secretary 

8 shall make determinations with respect to state9 ments submitted under this paragraph based on 

10 income data from the most recent tax return 

11 filed by the individual. 

12 ‘‘(6) DETERMINATIONS MADE WITH RESPECT

13 TO SAME TAXABLE YEARS.—In making determina14 tions under this section with respect to adjusted 

15 gross income as compared to the poverty line, the 

16 Secretary shall ensure that the poverty line data 

17 used relates to the same taxable year for which the 

18 adjusted gross income is determined. 

19 ‘‘(7) OUTREACH.—The Gateway shall conduct 

20 culturally and linguistically appropriate outreach ac21 tivities to provide information to individuals that 

22 may potentially be eligible for payments under this 

23 section. Such activities shall include information on 

24 the application process with respect to such pay25 ments. 


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1 ‘‘(e) EXCLUSION FROM INCOME.—Amounts received 

2 by an individual under this section shall not be considered 

3 as income, and shall not be taken into account in deter4 mining assets or resources for purposes of determining the 

5 eligibility of such individual, or any other individual, for 

6 benefits or assistance, or the amount or extent of benefits 

7 or assistance, under any Federal program or under any 

8 State or local program financed in whole or in part with 

9 Federal funds. 

10 ‘‘(f) CONFLICT.—A Gateway may not establish rules 

11 that conflict with or prevent the application of regulations 

12 promulgated by the Secretary under this title. 

13 ‘‘(g) NO FEDERAL FUNDING.—Nothing in this title 

14 shall allow Federal payments for individuals who are not 

15 lawfully present in the United States. 

16 ‘‘(h) APPROPRIATION.—Out of any funds in the 

17 Treasury of the United States not otherwise appropriated, 

18 there are appropriated such sums as may be necessary to 

19 carry out this section for each fiscal year. 

20 ‘‘SEC. 3112. SMALL BUSINESS HEALTH OPTIONS PROGRAM 

21 CREDIT. 

22 ‘‘(a) CALCULATION OF CREDIT.—For each calendar 

23 year beginning in calendar year 2010, in the case of an 

24 employer that is a qualified small employer, out of any 

25 funds in the Treasury of the United States not otherwise 


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1 appropriated, the Secretary shall make a payment to such 

2 qualified small employer in the amount described in sub3 section (b). 

4 ‘‘(b) GENERAL CREDIT AMOUNT.—For purposes of 

5 this section: 

6 ‘‘(1) IN GENERAL.—The credit amount de7 scribed in this subsection shall be the product of— 

8 ‘‘(A) the applicable amount specified in 

9 paragraph (2); 

10 ‘‘(B) the employer size factor specified in 

11 paragraph (3); and 

12 ‘‘(C) the percentage of year factor specified 

13 in paragraph (4). 

14 ‘‘(2) APPLICABLE AMOUNT.—For purposes of 

15 paragraph (1): 

16 ‘‘(A) IN GENERAL.—The applicable 

17 amount shall be equal to— 

18 ‘‘(i) $1,000 for each employee of the 

19 employer who receives self-only health in20 surance coverage through the employer; 

21 ‘‘(ii) $2,000 for each employee of the 

22 employer who receives family health insur23 ance coverage through the employer; and 

24 ‘‘(iii) $1,500 for each employee of the 

25 employer who receives health insurance 


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1 coverage for two adults or one adult and 

2 one or more children through the employer. 

3 ‘‘(B) BONUS FOR PAYMENT OF GREATER

4 PERCENTAGE OF PREMIUMS.—The applicable 

5 amount specified in subparagraph (A) shall be 

6 increased by $200 in the case of subparagraph 

7 (A)(i), $400 in the case of subparagraph 

8 (A)(ii), and $300 in the case of subparagraph 

9 (A)(iii), for each additional 10 percent of the 

10 qualified employee health insurance expenses 

11 exceeding 60 percent which are paid by the 

12 qualified small employer. 

13 ‘‘(3) EMPLOYER SIZE FACTOR.—For purposes 

14 of paragraph (1), the employer size factor shall be 

15 the percentage determined in accordance with the 

16 following: 

17 ‘‘(A) With respect to an employer with 10 

18 or fewer employees, the percentage shall be 100 

19 percent. 

20 ‘‘(B) With respect to an employer with 

21 more than 10, but not more than 20, full-time 

22 employees, the percentage shall be 80 percent. 

23 ‘‘(C) With respect to an employer with 

24 more than 20, but not more than 30, full-time 

25 employees, the percentage shall be 50 percent. 


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1 ‘‘(D) With respect to an employer with 

2 more than 30, but not more than 40, full-time 

3 employees, the percentage shall be 40 percent. 

4 ‘‘(E) With respect to an employer with 

5 more than 40, but not more than 50, full-time 

6 employees, the percentage shall be 20 percent. 

7 ‘‘(F) With respect to an employer with 

8 more than 50 full-time employees, the percent9 age shall be 0 percent. 

10 ‘‘(4) PERCENTAGE OF YEAR FACTOR.—For pur11 poses of paragraph (1), the percentage of year factor 

12 shall be equal to the ratio of— 

13 ‘‘(A) the number of months during the 

14 year for which the employer paid or incurred at 

15 least 60 percent of the qualified employee 

16 health insurance expenses of such employer; 

17 and 

18 ‘‘(B) 12. 

19 ‘‘(c) DEFINITIONS AND SPECIAL RULES.—For pur20 poses of this section: 

21 ‘‘(1) QUALIFIED SMALL EMPLOYER.— 

22 ‘‘(A) IN GENERAL.—The term ‘qualified 

23 small employer’ means an employer (as defined 

24 in section 3(d) of the Fair Labor Standards Act 


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1 of 1938 and including self-employed individ2 uals) that— 

3 ‘‘(i) pays or incurs at least 60 percent 

4 of the qualified employee health insurance 

5 expenses of such employer, or who is self6 employed; and 

7 ‘‘(ii) was— 

8 ‘‘(I) an employer that— 

9 ‘‘(aa) employed an average 

10 of 50 or fewer full-time employ11 ees during the preceding taxable 

12 year; and 

13 ‘‘(bb) had an average wage 

14 of less than $50,000 for full time 

15 employees in the preceding tax16 able year; or 

17 ‘‘(II) a self-employed individual 

18 that— 

19 ‘‘(aa) had not less than 

20 $5,000 in net earnings; 

21 ‘‘(bb) had not greater than 

22 $50,000 in net earnings; and 

23 ‘‘(cc) has elected not to re24 ceive a credit under section 3111. 


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1 ‘‘(B) LIMITATION.—An employer may not 

2 receive a credit under this section for more than 

3 1 period of not more than 3 consecutive years. 

4 ‘‘(2) QUALIFIED EMPLOYEE HEALTH INSUR5 ANCE EXPENSES.— 

6 ‘‘(A) IN GENERAL.—The term ‘qualified 

7 employee health insurance expenses’ means any 

8 amount paid by an employer or an employee of 

9 such employer for health insurance coverage to 

10 the extent such amount is for coverage— 

11 ‘‘(i) provided to any employee (as de12 fined in section 3(e) of the Fair Labor 

13 Standards Act of 1938), or 

14 ‘‘(ii) for a self-employed individual. 

15 ‘‘(B) EXCEPTION FOR AMOUNTS PAID

16 UNDER SALARY REDUCTION ARRANGEMENTS.— 

17 No amount paid or incurred for health insur18 ance coverage pursuant to a salary reduction 

19 arrangement shall be taken into account for 

20 purposes of subparagraph (A). 

21 ‘‘(3) FULL-TIME EMPLOYEE.—The term ‘full 

22 time employee’ means, with respect to any period, an 

23 employee (as defined in section 3(e) of the Fair 

24 Labor Standards Act of 1938) of an employer if the 

25 average number of hours worked by such employee 


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1 in the preceding taxable year for such employer was 

2 at least 40 hours per week. 

3 ‘‘(d) INFLATION ADJUSTMENT.— 

4 ‘‘(1) IN GENERAL.—For each calendar year 

5 after 2010, the dollar amounts specified in sub6 sections (b)(2)(A), (b)(2)(B), and (c)(1)(A)(ii) (after 

7 the application of this paragraph) shall be the 

8 amounts in effect in the preceding calendar year or, 

9 if greater, the product of— 

10 ‘‘(A) the corresponding dollar amount 

11 specified in such subsection; and 

12 ‘‘(B) the ratio of the index of wage infla13 tion (as determined by the Bureau of Labor 

14 Statistics) for August of the preceding calendar 

15 year to such index of wage inflation for August 

16 of 2008. 

17 ‘‘(2) ROUNDING.—If any amount determined 

18 under paragraph (1) is not a multiple of $100, such 

19 amount shall be rounded to the next lowest multiple 

20 of $100. 

21 ‘‘(e) APPLICATION OF CERTAIN RULES IN DETER22 MINATION OF EMPLOYER SIZE.—For purposes of this sec23 tion: 

24 ‘‘(1) APPLICATION OF AGGREGATION RULE FOR

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1 ployer under subsection (b), (c), (m), or (o) of sec2 tion 414 of the Internal Revenue Code of 1986 shall 

3 be treated as 1 employer. 

4 ‘‘(2) EMPLOYERS NOT IN EXISTENCE IN PRE5 CEDING YEAR.—In the case of an employer which 

6 was not in existence for the full preceding taxable 

7 year, the determination of whether such employer 

8 meets the requirements of this section shall be based 

9 on the average number of full-time employees that it 

10 is reasonably expected such employer will employ on 

11 business days in the employer’s first full taxable 

12 year. 

13 ‘‘(3) PREDECESSORS.—Any reference in this 

14 subsection to an employer shall include a reference 

15 to any predecessor of such employer.’’. 

16 SEC. 152. PROGRAM INTEGRITY. 

17 (a) IN GENERAL.—Subsection (l) of section 6103 of 

18 the Internal Revenue Code of 1986 is amended by adding 

19 at the end the following new paragraph: 

20 ‘‘(21) VOLUNTARY AUTHORIZATION FOR IN21 COME VERIFICATION.— 

22 ‘‘(A) VOLUNTARY AUTHORIZATION.—The 

23 Secretary shall provide a mechanism for each 

24 taxpayer to indicate whether such taxpayer au25 thorizes the Secretary to disclose to the SecVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00158 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 retary of Health and Human Services (or, pur2 suant to a delegation described in subsection 

3 (d)(4)(B), to a State or a Gateway (as defined 

4 in section 3101 of the Public Health Service 

5 Act) return information of a taxpayer who may 

6 be eligible for credits under section 3111 of the 

7 Public Health Service Act. 

8 ‘‘(B) PROVISION OF INFORMATION.—If a 

9 taxpayer authorizes the disclosure described in 

10 subparagraph (A), the Secretary shall disclose 

11 to the Secretary of Health and Human Services 

12 (or, pursuant to a delegation described in sub13 section (d)(4)(B), to a State or a Gateway) the 

14 minimum necessary amount of information nec15 essary to establish whether such individual is el16 igible for credits under section 3111 of the 

17 Public Health Service Act. 

18 ‘‘(C) RESTRICTION ON USE OF DISCLOSED

19 INFORMATION.—Return information disclosed 

20 under subparagraph (A) may be used by the 

21 Secretary (or, pursuant to a delegation de22 scribed in subsection (d)(4)(B), a State or a 

23 Gateway) only for the purposes of, and to the 

24 extent necessary in, establishing the appropriate 


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1 amount of any payments under section 3111 of 

2 the Public Health Service Act.’’. 

3 (b) COLLECTION OF AMOUNTS.—Section 6305(a) of 

4 the Internal Revenue Code of 1986 is amended by insert5 ing ‘‘or under section 3111 of the Public Health Service 

6 Act’’ after ‘‘Social Security Act’’. 

7 (c) CONFORMING AMENDMENTS.— 

8 (1) Paragraph (3) of section 6103(a) of such 

9 Code is amended by striking ‘‘or (20)’’ and inserting 

10 ‘‘(20), or (21)’’. 

11 (2) Paragraph (4) of section 6103(p) of such 

12 Code is amended by striking ‘‘(l)(10), (16), (18), 

13 (19), or (20)’’ each place it appears and inserting 

14 ‘‘(l)(10), (16), (18), (19), (20), or (21)’’. 

15 (3) Paragraph (2) of section 7213(a) of such 

16 Code is amended by striking ‘‘or (20)’’ and inserting 

17 ‘‘(20), or (21)’’. 

18 Subtitle D—Shared Responsibility 

19 for Health Care 

20 SEC. 161. INDIVIDUAL RESPONSIBILITY. 

21 (a) PAYMENTS.— 

22 (1) IN GENERAL.—Subchapter A of chapter 1 

23 of the Internal Revenue Code of 1986 (relating to 

24 determination of tax liability) is amended by adding 

25 at the end the following new part: 


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1 ‘‘PART VIII—SHARED RESPONSIBILITY 

2 PAYMENTS 

‘‘Sec. 59B. Shared responsibility payments. 

3 ‘‘SEC. 59B. SHARED RESPONSIBILITY PAYMENTS. 

4 ‘‘(a) REQUIREMENT.—Every individual shall ensure 

5 that such individual, and each dependent of such indi6 vidual, is covered under qualifying coverage at all times 

7 during the taxable year. 

8 ‘‘(b) PAYMENT.— 

9 ‘‘(1) IN GENERAL.— 

10 ‘‘(A) IN GENERAL.—In the case of any in11 dividual who did not have in effect qualifying 

12 coverage (as defined in section 3116 of the 

13 Public Health Service Act) for any month dur14 ing the taxable year, there is hereby imposed 

15 for the taxable year, in addition to any other 

16 amount imposed by this subtitle, an amount 

17 equal to the amount established under para18 graph (2). 

19 ‘‘(B) RULE FOR DEPENDENTS.—Any 

20 amount to be imposed under this subsection 

21 with respect to an individual described in sub22 paragraph (A) that is a dependent (as defined 

23 in section 152) of another taxpayer shall be im24 posed— 


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1 ‘‘(i) except in any case described in 

2 clause (ii), upon the taxpayer on whom 

3 such individual is a dependent; or 

4 ‘‘(ii) in any case in which the taxpayer 

5 with respect to whom such individual is a 

6 dependent files a joint return, jointly upon 

7 the taxpayer and the spouse of the tax8 payer. 

9 ‘‘(C) LIMITATION.—The maximum amount 

10 imposed under this paragraph with respect to 

11 any taxpayer shall not exceed 4 times the 

12 amount determined under paragraph (2)(D). 

13 ‘‘(2) AMOUNT ESTABLISHED.— 

14 ‘‘(A) REQUIREMENT TO ESTABLISH.—Not 

15 later than June 30 of each calendar year, the 

16 Secretary, in consultation with the Secretary of 

17 Health and Human Services and with the 

18 States, shall establish an amount for purposes 

19 of paragraph (1). 

20 ‘‘(B) EFFECTIVE DATE.—The amount es21 tablished under subparagraph (A) shall be ef22 fective with respect to the taxable year following 

23 the date on which the amount under subpara24 graph (A) is established. 


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1 ‘‘(C) REQUIRED CONSIDERATION.—Subject 

2 to the limitation described in subparagraph (D), 

3 in establishing the amount under subparagraph 

4 (A), the Secretary shall seek to establish the 

5 minimum practicable amount that can accom6 plish the goal of enhancing participation in 

7 qualifying coverage (as so defined). 

8 ‘‘(D) LIMITATION.— 

9 ‘‘(i) IN GENERAL.—Subject to an ad10 justment under clause (ii), the amount es11 tablished under this subparagraph is $750. 

12 ‘‘(ii) INFLATION ADJUSTMENT.—Be13 ginning with taxable years after 2011, the 

14 amount described in clause (i) shall be ad15 justed by the Secretary by notice, pub16 lished in the Federal Register, for each fis17 cal year to reflect the total percentage 

18 change that occurred in the medical care 

19 component of the Consumer Price Index 

20 for all urban consumers (all items; U.S. 

21 city average) during the preceding calendar 

22 year. 

23 ‘‘(c) EXEMPTIONS.—Subsection (b) shall not apply to 

24 any individual— 


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1 ‘‘(1) with respect to any month if such month 

2 occurs during any period in which such individual 

3 did not have qualifying coverage (as so defined) for 

4 a period of less than 90 days, 

5 ‘‘(2) who is a resident of a State that is not a 

6 participating State or an establishing State (as such 

7 terms are defined in section 3104 of the Public 

8 Health Service Act), 

9 ‘‘(3) who is an Indian as defined in section 4 

10 of the Indian Health Care Improvement Act, 

11 ‘‘(4) for whom affordable health care coverage 

12 is not available (as such terms are defined by the 

13 Secretary of Health and Human Services under sec14 tion 3103 of the Public Health Service Act), or 

15 ‘‘(5) described in section 3116(a)(4)(C) of the 

16 Public Health Service Act. 

17 ‘‘(d) COORDINATION WITH OTHER PROVISIONS.— 

18 ‘‘(1) NOT TREATED AS TAX FOR CERTAIN PUR19 POSES.—The amount imposed by this section shall 

20 not be treated as a tax imposed by this chapter for 

21 purposes of determining— 

22 ‘‘(A) the amount of any credit allowable 

23 under this chapter, or 

24 ‘‘(B) the amount of the minimum tax im25 posed by section 55. 


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1 ‘‘(2) TREATMENT UNDER SUBTITLE F.—For 

2 purposes of subtitle F, the amount imposed by this 

3 section shall be treated as if it were a tax imposed 

4 by section 1. 

5 ‘‘(3) SECTION 15 NOT TO APPLY.—Section 15 

6 shall not apply to the amount imposed by this sec7 tion. 

8 ‘‘(4) SECTION NOT TO AFFECT LIABILITY OF

9 POSSESSIONS, ETC.—This section shall not apply for 

10 purposes of determining liability to any possession of 

11 the United States. For purposes of section 932 and 

12 7654, the amount imposed under this section shall 

13 not be treated as a tax imposed by this chapter. 

14 ‘‘(e) USES.—Amounts collected under this section 

15 shall be dedicated to premium credits established under 

16 section 3111 of the Public Health Service Act. 

17 ‘‘(f) REGULATIONS.—The Secretary may prescribe 

18 such regulations as may be appropriate to carry out the 

19 purposes of this section.’’. 

20 (2) CLERICAL AMENDMENT.—The table of 

21 parts for subchapter A of chapter 1 of such Code is 

22 amended by adding at the end the following new 

23 item: 

‘‘PART VIII—SHARED RESPONSIBILITY PAYMENTS’’. 


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1 (3) EFFECTIVE DATE.—The amendments made 

2 by this section shall apply to taxable years beginning 

3 after December 31, 2011. 

4 (b) REPORTING OF HEALTH INSURANCE COV5 ERAGE.— 

6 (1) IN GENERAL.—Part III of subchapter A of 

7 chapter 61 of the Internal Revenue Code of 1986 is 

8 amended by inserting after subpart B the following 

9 new subpart: 

10 ‘‘Subpart D—Information Regarding Health 

11 Insurance Coverage 

‘‘Sec. 6055. Reporting of health insurance coverage. 

12 ‘‘SEC. 6055. REPORTING OF HEALTH INSURANCE COV13 ERAGE. 

14 ‘‘(a) IN GENERAL.—Every person who provides 

15 health insurance that is qualifying coverage shall make a 

16 return described in subsection (b). 

17 ‘‘(b) FORM AND MANNER OF RETURN.—A return is 

18 described in this subsection if such return— 

19 ‘‘(1) is in such form as the Secretary pre20 scribes, 

21 ‘‘(2) contains— 

22 ‘‘(A) the name, address, and taxpayer 

23 identification number of each individual who is 


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1 covered under health insurance that is quali2 fying coverage provided by such person, and 

3 ‘‘(B) the number of months during the cal4 endar year during which each such individual 

5 was covered under such health insurance, and 

6 ‘‘(3) such other information as the Secretary 

7 may prescribe. 

8 ‘‘(c) STATEMENTS TO BE FURNISHED TO INDIVID9 UALS WITH RESPECT TO WHOM INFORMATION IS RE10 PORTED.— 

11 ‘‘(1) IN GENERAL.—Every person required to 

12 make a return under subsection (a) shall furnish to 

13 each individual whose name is required to be set 

14 forth in such return a written statement showing— 

15 ‘‘(A) the name, address, and phone num16 ber of the information contact of the person re17 quired to make such return, and 

18 ‘‘(B) the number of months during the cal19 endar year during which such individual was 

20 covered under health insurance that is quali21 fying coverage provided by such person. 

22 ‘‘(2) TIME FOR FURNISHING STATEMENTS.— 

23 The written statement required under paragraph (1) 

24 shall be furnished on or before January 31 of the 


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1 year following the calendar year for which the return 

2 under subsection (a) was required to be made. 

3 ‘‘(d) QUALIFYING COVERAGE.—For purposes of this 

4 section, the term ‘qualifying coverage’ has the meaning 

5 given such term under section 3116 of the Public Health 

6 Service Act.’’. 

7 (2) CONFORMING AMENDMENTS.—The table of 

8 subparts for part III of subchapter A of chapter 61 

9 of such Code is amended by inserting after the item 

10 relating to subpart C the following new item: 

‘‘SUBPART D—HEALTH INSURANCE COVERAGE’’. 

11 (3) EFFECTIVE DATE.—The amendments made 

12 by this section shall apply to taxable years beginning 

13 after December 31, 2011. 

14 (c) NOTIFICATION OF NONENROLLMENT.—Not later 

15 than June 30 of each year, the Secretary of the Treasury, 

16 acting through the Internal Revenue Service and in con17 sultation with the Secretary of Health and Human Serv18 ices, shall send a notification each individual who files an 

19 individual income tax return and who is not enrolled in 

20 qualifying coverage (as defined in section 3116 of the Pub21 lic Health Service Act). Such notification shall contain in22 formation on the services available through the Gateway 

23 (if any) operating in the State in which such individual 

24 resides. 


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1 SEC. 162. NOTIFICATION ON THE AVAILABILITY OF AF2 FORDABLE HEALTH CHOICES. 

3 The Fair Labor Standards Act of 1938 is amended 

4 by inserting after section 18 (29 U.S.C. 218) the fol5 lowing: 

6 ‘‘SEC. 18A. NOTICE TO EMPLOYEES. 

7 ‘‘(a) IN GENERAL.—In accordance with regulations 

8 promulgated by the Secretary, an employer to which this 

9 Act applies, shall provide to each employee at the time 

10 of hiring (or with respect to current employees, within 90 

11 days of the date on which a State becomes an establishing 

12 or participating State under section 3104 of the Public 

13 Health Service Act), written notice informing the em14 ployee of the existence of the American Health Benefits 

15 Gateway, including a description of the services provided 

16 by such Gateway and the manner in which the employee 

17 may contact the Gateway to request assistance. 

18 ‘‘(b) EFFECTIVE DATE.—Subsection (a) shall take 

19 effect with respect to employers in a State beginning 90 

20 days after the date on which the State becomes an estab21 lishing or participating State under section 3104 of the 

22 Public Health Service. Act.’’. 

23 SEC. 163. SHARED RESPONSIBILITY OF EMPLOYERS. 

24 Subtitle B of title XXXI of the Public Health Service 

25 Act, as amended by section 151, is further amended by 

26 adding at the end the following: 


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1 ‘‘SEC. 3115. SHARED RESPONSIBILITY OF EMPLOYERS. 

2 ‘‘(a) EMPLOYEES NOT OFFERED COVERAGE.—An 

3 employer shall make a payment to the Secretary in the 

4 amount described in subsection (b) with respect to each 

5 employee— 

6 ‘‘(1) who is not offered qualifying coverage by 

7 such employer during each month where such em8 ployee is not offered qualifying coverage; or 

9 ‘‘(2) on behalf of whom such employer is not 

10 contributing at least 60 percent of the monthly pre11 miums for such coverage for each such month. 

12 ‘‘(b) AMOUNT.— 

13 ‘‘(1) IN GENERAL.—The annual amount de14 scribed in this subsection shall be equal to $750 for 

15 each full-time employee described in subsection (a). 

16 Such amount shall be pro-rated with respect to each 

17 month in which subsection (a) applies with respect 

18 to an employee. 

19 ‘‘(2) PRO RATA APPLICATION FOR PART-TIME

20 EMPLOYEES.—The provisions of paragraph (1) shall 

21 apply with respect to part-time employees employed 

22 by the employer, except that the annual payment 

23 amount described in such paragraph shall be re24 duced to $375 for each part-time employee. 

25 ‘‘(3) APPLICATION.—The provisions of this sub26 section shall only apply with respect to the number 


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1 of employees employed by the employer in excess of 

2 25 employees. 

3 ‘‘(c) PROCEDURES.—The Secretary shall develop pro4 cedures for making determinations with respect to quali5 fying coverage and for making the payments required 

6 under subsection (a). Such procedures shall provide for 

7 the making of payments on a quarterly basis. 

8 ‘‘(d) USE OF FUNDS.—Amounts shall be collected 

9 under subsection (a) and be available for obligation only 

10 to the extent and in the amount provided in advance in 

11 appropriations Acts. Such amounts are authorized to re12 main available until expended. 

13 ‘‘(e) INFLATION ADJUSTMENT.—Beginning with cal14 endar years after 2013, the amounts described in sub15 section (b) shall be adjusted by the Secretary by notice, 

16 published in the Federal Register, for each fiscal year to 

17 reflect the total percentage change that occurred in the 

18 medical care component of the Consumer Price Index for 

19 all urban consumers (all items; U.S. city average) during 

20 the preceding calendar year. 

21 ‘‘(f) EXEMPTION FOR SMALL EMPLOYERS.— 

22 ‘‘(1) IN GENERAL.—For purposes of this sec23 tion, the term ‘employer’ means an employer that 

24 employs more than 25 employees on business days 

25 during the preceding calendar year. An employer 


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1 shall not be considered to employ more than 25 em2 ployees if— 

3 ‘‘(A) the employer’s workforce exceeds 25 

4 employees for 120 days or fewer during the cal5 endar year; and 

6 ‘‘(B) the employees employed during such 

7 120-day period were seasonal workers. 

8 ‘‘(2) DEFINITION OF SEASONAL WORKERS.—In 

9 this subsection, the term ‘seasonal worker’ means an 

10 individual who performs labor or services on a sea11 sonal basis where, ordinarily, the employment per12 tains to or is of the kind exclusively performed at 

13 certain seasons or periods of the year and which, 

14 from its nature, may not be continuous or carried on 

15 throughout the year. 

16 ‘‘(3) APPLICATION OF AGGREGATION RULE FOR

17 EMPLOYERS.—All persons treated as a single em18 ployer under subsection (b), (c), (m), or (o) of sec19 tion 414 of the Internal Revenue Code of 1986 shall 

20 be treated as 1 employer. 

21 ‘‘(4) EMPLOYERS NOT IN EXISTENCE IN PRE22 CEDING YEAR.—In the case of an employer which 

23 was not in existence throughout the preceding cal24 endar year, the determination of whether such em25 ployer is a small or large employer shall be based on 


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1 the average number of employees that it is reason2 ably expected such employer will employ on business 

3 days in the current calendar year. 

4 ‘‘(5) PREDECESSORS.—Any reference in this 

5 subsection to an employer shall include a reference 

6 to any predecessor of such employer. 

7 ‘‘(g) AUTHORITY TO CERTIFY.—The Secretary, in 

8 collaboration with the Secretary of the Treasury and the 

9 Secretary of Labor, shall establish procedures for deter10 mining the number of employees of employers who are not 

11 offered qualifying coverage. 

12 ‘‘(h) INDEPENDENT CONTRACTORS.—For purposes 

13 of determining whether an employer is subject to this sec14 tion, any individual who qualifies as an independent con15 tractor under Federal law and who is retained by such 

16 employer shall not be counted when determining the num17 ber of employees employed by the employer. 

18 ‘‘(i) REGULATIONS.—The Secretary, in consultation 

19 with the Secretary of Labor, shall promulgate such regula20 tions as may be appropriate to carry out activities under 

21 this section. 

22 ‘‘(j) EFFECTIVE DATE.—This section shall apply 

23 with respect to an employer beginning in the calendar year 

24 in which the State in which the employer is located be25 comes an establishing State or a participating State. 


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1 ‘‘SEC. 3116. DEFINITIONS. 

2 ‘‘(a) IN GENERAL.—In this title: 

3 ‘‘(1) ELIGIBLE INDIVIDUAL.—The term ‘eligible 

4 individual’ means an individual who is— 

5 ‘‘(A) a citizen or national of the United 

6 States or an alien lawfully admitted to the 

7 United States for permanent residence or an 

8 alien lawfully present in the United States; 

9 ‘‘(B) a qualified individual; 

10 ‘‘(C) enrolled in a qualified health plan; 

11 and 

12 ‘‘(D) not receiving full benefits coverage 

13 under a State child health plan under title XXI 

14 of the Social Security Act (42 U.S.C. 1397aa et 

15 seq.) (or full benefits coverage under a dem16 onstration project funded through such title 

17 XXI). 

18 ‘‘(2) QUALIFIED EMPLOYER.— 

19 ‘‘(A) IN GENERAL.—The term ‘qualified 

20 employer’ means an employer that— 

21 ‘‘(i) elects to make all full-time em22 ployees of such employer eligible for a 

23 qualified health plan; and 

24 ‘‘(ii)(I) in the case of an employer 

25 that elects to make its employees eligible 


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1 for qualified health plans in an establishing 

2 State— 

3 ‘‘(aa) employs fewer than the 

4 number of employees specified in sub5 paragraph (B); and 

6 ‘‘(bb) meets criteria established 

7 by the State; or 

8 ‘‘(II) in the case of an employer that 

9 elects to make its employees eligible for 

10 qualified health plans in a participating 

11 State— 

12 ‘‘(aa) employs fewer than the 

13 number of employees specified in sub14 paragraph (B); and 

15 ‘‘(bb) meets criteria established 

16 by the Secretary. 

17 ‘‘(B) NUMBER OF EMPLOYEES.— 

18 ‘‘(i) ESTABLISHMENT.— 

19 ‘‘(I) BY STATE.—In the case of 

20 an establishing State, such State may 

21 by regulation establish the number of 

22 employees described in subparagraph 

23 (A)(ii)(I)(aa) but such number may 

24 not be less than 50. 


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1 ‘‘(II) BY THE SECRETARY.—In 

2 the case of a participating State, the 

3 Secretary may by regulation establish 

4 the number of employees described in 

5 subparagraph (A)(ii)(II)(aa) but such 

6 number may not be less than 50. 

7 ‘‘(ii) DEFAULT.—If a State or the 

8 Secretary does not establish the number 

9 described in subclause (I) or (II), respec10 tively, of clause (i), such number shall be 

11 50. 

12 ‘‘(C) CONTINUATION OF PARTICIPATION.— 

13 A qualified employer that is enrolled in a quali14 fied health plan and that experiences an in15 crease in the number of employees of such em16 ployer such that the number of employees of 

17 such employer exceeds the number specified in 

18 subparagraph (B)(i) or subparagraph (B)(ii), as 

19 applicable, shall, notwithstanding such increase, 

20 continue to be considered a qualified employer 

21 for purposes of this title, provided that such 

22 employer remains enrolled in a qualified health 

23 plan. 

24 ‘‘(3) QUALIFIED HEALTH PLAN.— 


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1 ‘‘(A) IN GENERAL.—The term ‘qualified 

2 health plan’ means health plan that— 

3 ‘‘(i) has in effect a certification (which 

4 may include a seal or other indication of 

5 approval) that such plan meets the criteria 

6 for certification described in section 

7 3101(m) issued or recognized by each 

8 Gateway through which such plan is of9 fered; and 

10 ‘‘(ii) is offered by a health insurance 

11 issuer that— 

12 ‘‘(I) is licensed and in good 

13 standing to offer health insurance cov14 erage in each State in which such 

15 issuer offers health insurance coverage 

16 under this title; 

17 ‘‘(II) agrees to offer at least one 

18 qualified health plan in the tier de19 scribed in section 3111(a)(1)(A) and 

20 at least one plan in the tier described 

21 in section 3111(a)(1)(B); 

22 ‘‘(III) complies with the regula23 tions developed by the Secretary 

24 under section 3101(m) and such other 


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1 requirements as an applicable Gate2 way may establish; and 

3 ‘‘(IV) agrees to pay any sur4 charge assessed under section 

5 3101(c)(4). 

6 ‘‘(B) INCLUSION OF COMMUNITY HEALTH

7 INSURANCE OPTION.—Any reference in this title 

8 to a qualified health plan shall be deemed to in9 clude a community health insurance option, un10 less specifically provided for otherwise. 

11 ‘‘(4) QUALIFIED INDIVIDUAL.— 

12 ‘‘(A) IN GENERAL.—The term ‘qualified 

13 individual’ means an individual who is— 

14 ‘‘(i) residing in a participating State 

15 or an establishing State (as defined in sec16 tion 3104); 

17 ‘‘(ii) not incarcerated, except an indi18 vidual in custody pending the disposition of 

19 charges; 

20 ‘‘(iii) not entitled to coverage under 

21 the Medicare program under part A of title 

22 XVIII of the Social Security Act; 

23 ‘‘(iv) not enrolled in coverage under 

24 the Medicare program under part B of title 


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1 XVIII of the Social Security Act or under 

2 part C of such title; and 

3 ‘‘(v) not eligible for coverage under— 

4 ‘‘(I) the Medicaid program under 

5 a State plan under title XIX of the 

6 Social Security Act (42 U.S.C. 1396 

7 et seq.), or under a waiver under sec8 tion 1115 of such Act; 

9 ‘‘(II) the TRICARE program 

10 under chapter 55 of title 10, United 

11 States Code (as defined in section 

12 1072(7) of such title); 

13 ‘‘(III) the Federal employees 

14 health benefits program under chapter 

15 89 of title 5, United States Code; or 

16 ‘‘(IV) employer-sponsored cov17 erage (except as provided under sub18 paragraph (B)). 

19 ‘‘(B) EMPLOYEES WITHOUT AFFORDABLE

20 COVERAGE.—An individual who is eligible for 

21 employer-sponsored coverage shall be deemed to 

22 be a qualified individual under subparagraph 

23 (A) only if such coverage— 


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1 ‘‘(i) does not meet the criteria estab2 lished under section 3103 for minimum 

3 qualifying coverage; or 

4 ‘‘(ii) is not affordable (as such term is 

5 defined by the Secretary under section 

6 3103) for such employee. 

7 ‘‘(C) INDIVIDUALS AT LESS THAN 150 PER8 CENT OF POVERTY.—An individual with an ad9 justed gross income that does not exceed 150 

10 percent of the poverty line for a family of the 

11 size involved shall not be considered a qualified 

12 individual for purposes of this title. 

13 ‘‘(5) QUALIFYING COVERAGE.—The term ‘quali14 fying coverage’ means— 

15 ‘‘(A) a group health plan or health insur16 ance coverage— 

17 ‘‘(i) that an individual is enrolled in 

18 on the date of enactment of this title; or 

19 ‘‘(ii) that is described in clause (i) and 

20 that is renewed by an enrollee as provided 

21 for in section 131 of the Affordable Health 

22 Choices Act; 

23 ‘‘(B) a group health plan or health insur24 ance coverage that— 


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1 ‘‘(i) is not described in subparagraph 

2 (A); and 

3 ‘‘(ii) meets or exceeds the criteria for 

4 minimum qualifying coverage (as defined 

5 in section 3103); 

6 ‘‘(C) Medicare coverage under parts A and 

7 B of title XVIII of the Social Security Act or 

8 under part C of such title; 

9 ‘‘(D) Medicaid coverage under a State plan 

10 under title XIX of the Social Security Act (or 

11 under a waiver under section 1115 of such 

12 Act), other than coverage consisting solely of 

13 benefits under section 1928 of such Act; 

14 ‘‘(E) coverage under title XXI of the So15 cial Security Act; 

16 ‘‘(F) coverage under the TRICARE pro17 gram under chapter 55 of title 10, United 

18 States Code; 

19 ‘‘(G) coverage under the veteran’s health 

20 care program under chapter 17 of title 38, 

21 United States Code, but only if the coverage for 

22 the individual involved is determined by the 

23 Secretary to be not less than the coverage pro24 vided under a qualified health plan, based on 


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1 the individual’s priority for services as provided 

2 under section 1705(a) of such title; 

3 ‘‘(H) coverage under the Federal employ4 ees health benefits program under chapter 89 of 

5 title 5, United States Code; 

6 ‘‘(I) a State health benefits high risk pool; 

7 ‘‘(J) a health benefit plan under section 

8 2504(e) of title 22, United States Code; or 

9 ‘‘(K) coverage under a qualified health 

10 plan. 

11 For purposes of this paragraph, an individual shall 

12 be deemed to have qualifying coverage if such indi13 vidual is an individual described in section 1402(e) 

14 or (g) of the Internal Revenue Code of 1986. 

15 ‘‘(6) ADJUSTED GROSS INCOME.—The term ‘ad16 justed gross income’ with respect to an individual 

17 has the meaning given such term for purposes of 

18 section 62(a) of the Internal Revenue Code of 1986. 

19 ‘‘(7) EDUCATED HEALTH CARE CONSUMER.— 

20 The term ‘educated health care consumer’ means an 

21 individual who is knowledgeable about the health 

22 care system, and has background or experience in 

23 making informed decisions regarding health, med24 ical, and scientific matters. 


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1 ‘‘(b) INCORPORATION OF ADDITIONAL DEFINI2 TIONS.—Unless specifically provided for otherwise, the 

3 definitions contained in section 2791 shall apply with re4 spect to this title.’’. 

5 Subtitle E—Improving Access to 

6 Health Care Services 

7 SEC. 171. SPENDING FOR FEDERALLY QUALIFIED HEALTH 

8 CENTERS (FQHCS). 

9 (a) IN GENERAL.—Section 330(r) of the Public 

10 Health Service Act (42 U.S.C. 254b(r)) is amended by 

11 striking paragraph (1) and inserting the following: 

12 ‘‘(1) GENERAL AMOUNTS FOR GRANTS.—For 

13 the purpose of carrying out this section, in addition 

14 to the amounts authorized to be appropriated under 

15 subsection (d), there is authorized to be appro16 priated the following: 

17 ‘‘(A) For fiscal year 2010, 

18 $2,988,821,592. 

19 ‘‘(B) For fiscal year 2011, 

20 $3,862,107,440. 

21 ‘‘(C) For fiscal year 2012, $4,990,553,440. 

22 ‘‘(D) For fiscal year 2013, 

23 $6,448,713,307. 

24 ‘‘(E) For fiscal year 2014, 

25 $7,332,924,155. 


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1 ‘‘(F) For fiscal year 2015, 

2 $8,332,924,155. 

3 ‘‘(G) For fiscal year 2016, and each subse4 quent fiscal year, the amount appropriated for 

5 the preceding fiscal year adjusted by the prod6 uct of— 

7 ‘‘(i) one plus the average percentage 

8 increase in costs incurred per patient 

9 served; and 

10 ‘‘(ii) one plus the average percentage 

11 increase in the total number of patients 

12 served.’’. 

13 (b) RULE OF CONSTRUCTION.—Section 330(r) of the 

14 Public Health Service Act (42 U.S.C. 254b(r)) is amended 

15 by adding at the end the following: 

16 ‘‘(4) RULE OF CONSTRUCTION WITH RESPECT

17 TO RURAL HEALTH CLINICS.— 

18 ‘‘(A) IN GENERAL.—Nothing in this sec19 tion shall be construed to prevent a community 

20 health center from contracting with a Federally 

21 certified rural health clinic (as defined in sec22 tion 1861(aa)(2) of the Social Security Act), a 

23 low-volume hospital (as defined for purposes of 

24 section 1886 of such Act), a critical access hos25 pital, a sole community hospital (as defined for 


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1 purposes of section 1886(d)(5)(D)(iii) of such 

2 Act), or a medicare-dependent share hospital 

3 (as defined for purposes of section 

4 1886(d)(5)(G)(iv) of such Act) for the delivery 

5 of primary health care services that are avail6 able at the clinic or hospital to individuals who 

7 would otherwise be eligible for free or reduced 

8 cost care if that individual were able to obtain 

9 that care at the community health center. Such 

10 services may be limited in scope to those pri11 mary health care services available in that clinic 

12 or hospitals. 

13 ‘‘(B) ASSURANCES.—In order for a clinic 

14 or hospital to receive funds under this section 

15 through a contract with a community health 

16 center under subparagraph (A), such clinic or 

17 hospital shall establish policies to ensure— 

18 ‘‘(i) nondiscrimination based on the 

19 ability of a patient to pay; and 

20 ‘‘(ii) the establishment of a sliding fee 

21 scale for low-income patients.’’. 

22 SEC. 172. OTHER PROVISIONS. 

23 (a) SETTINGS FOR SERVICE DELIVERY.—Section 

24 330(a)(1) of the Public Health Service Act (42 U.S.C. 

25 254b(a)(1)) is amended by adding at the end the folVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00185 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 lowing: ‘‘Required primary health services and additional 

2 health services may be provided either at facilities directly 

3 operated by the center or at any other inpatient or out4 patient settings determined appropriate by the center to 

5 meet the needs of its patents.’’. 

6 (b) LOCATION OF SERVICE DELIVERY SITES.—Sec7 tion 330(a) of the Public Health Service Act (42 U.S.C. 

8 254b(a)) is amended by adding at the end the following: 

9 ‘‘(3) CONSIDERATIONS.— 

10 ‘‘(A) LOCATION OF SITES.—Subject to 

11 subparagraph (B), a center shall not be re12 quired to locate its service facility or facilities 

13 within a designated medically underserved area 

14 in order to serve either the residents of its 

15 catchment area or a special medically under16 served population comprised of migratory and 

17 seasonal agricultural workers, the homeless, or 

18 residents of public housing, if that location is 

19 determined by the center to be reasonably ac20 cessible to and appropriate to meet the needs of 

21 the medically underserved residents of the cen22 ter’s catchment area or the special medically 

23 underserved population, in accordance with sub24 paragraphs (A) and (J) of subsection (k)(3). 


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1 ‘‘(B) LOCATION WITHIN ANOTHER CEN2 TER’S AREA.—The Secretary may permit appli3 cants for grants under this section to propose 

4 the location of a service delivery site within an5 other center’s catchment area if the applicant 

6 demonstrates sufficient unmet need in such 

7 area and can otherwise justify the need for ad8 ditional Federal resources in the catchment 

9 area. In determining whether to approve such a 

10 proposal, the Secretary shall take into consider11 ation whether collaboration between the two 

12 centers exists, or whether the applicant has 

13 made reasonable attempts to establish such col14 laboration, and shall consider any comments 

15 timely submitted by the affected center con16 cerning the potential impact of the proposal on 

17 the availability or accessibility of services the 

18 affected center currently provides or the finan19 cial viability of the affected center.’’. 

20 (c) AFFILIATION AGREEMENTS.—Section 

21 330(k)(3)(B) of the Public Health Service Act (42 U.S.C. 

22 254b(k)(3)(B)) is amended by inserting before the semi23 colon the following: ‘‘, including contractual arrangements 

24 as appropriate, while maintaining full compliance with the 

25 requirements of this section, including the requirements 


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1 of subparagraph (H) concerning the composition and au2 thorities of the center’s governing board, and, except as 

3 otherwise provided in clause (ii) of such subparagraph, en4 suring full autonomy of the center over policies, direction, 

5 and operations related to health care delivery, personnel, 

6 finances, and quality assurance’’. 

7 (d) GOVERNANCE REQUIREMENTS.—Section 

8 330(k)(3) of the Public Health Service Act (42 U.S.C. 

9 254b(k)(3)) is amended— 

10 (1) in subparagraph (H)— 

11 (A) in clause (ii), strike ‘‘; and’’ and in12 serting ‘‘, except that in the case of a public 

13 center (as defined in the second sentence of this 

14 paragraph), the public entity may retain au15 thority to establish financial and personnel poli16 cies for the center; and’’; 

17 (B) in clause (iii), by adding ‘‘and’’ at the 

18 end; and 

19 (C) by inserting after clause (iii) the fol20 lowing: 

21 ‘‘(iv) in the case of a co-applicant with 

22 a public entity, meets the requirements of 

23 clauses (i) and (ii);’’; and 

24 (2) in the second sentence, by inserting before 

25 the period the following: ‘‘that is governed by a 


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1 board that satisfies the requirements of subpara2 graph (H) or that jointly applies (or has applied) for 

3 funding with a co-applicant board that meets such 

4 requirements’’. 

5 (e) ADJUSTMENT IN CENTER’S OPERATING PLAN

6 AND BUDGET.—Section 330(k)(3)(I)(i) of the Public 

7 Health Service Act (42 U.S.C. 254b(k)(3)(I)(i)) is amend8 ed by adding before the semicolon the following: ‘‘, which 

9 may be modified by the center at any time during the fis10 cal year involved if such modifications do not require addi11 tional grant funds, do not compromise the availability or 

12 accessibility of services currently provided by the center, 

13 and otherwise meet the conditions of subsection (a)(3)(B), 

14 except that any such modifications that do not comply 

15 with this clause, as determined by the health center, shall 

16 be submitted to the Secretary for approval’’. 

17 (f) JOINT PURCHASING ARRANGEMENTS FOR RE18 DUCED COST.—Section 330(l) of the Public Health Serv19 ice Act (42 U.S.C. 254b(l)) is amended— 

20 (1) by striking ‘‘The Secretary’’ and inserting 

21 the following: 

22 ‘‘(1) IN GENERAL.—The Secretary’’; and 

23 (2) by adding at the end the following: 

24 ‘‘(2) ASSISTANCE WITH SUPPLIES AND SERV25 ICES COSTS.—The Secretary, directly or through 


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1 grants or contracts, may carry out projects to estab2 lish and administer arrangements under which the 

3 costs of providing the supplies and services needed 

4 for the operation of federally qualified health centers 

5 are reduced through collaborative efforts of the cen6 ters, through making purchases that apply to mul7 tiple centers, or through such other methods as the 

8 Secretary determines to be appropriate.’’. 

9 (g) OPPORTUNITY TO CORRECT MATERIAL FAILURE

10 REGARDING GRANT CONDITIONS.—Section 330(e) of the 

11 Public Health Service Act (42 U.S.C. 254b(e)) is amended 

12 by adding at the end the following: 

13 ‘‘(6) OPPORTUNITY TO CORRECT MATERIAL

14 FAILURE REGARDING GRANT CONDITIONS.—If the 

15 Secretary finds that a center materially fails to meet 

16 any requirement (except for any requirements 

17 waived by the Secretary) necessary to qualify for its 

18 grant under this subsection, the Secretary shall pro19 vide the center with an opportunity to achieve com20 pliance (over a period of up to 1 year from making 

21 such finding) before terminating the center’s grant. 

22 A center may appeal and obtain an impartial review 

23 of any Secretarial determination made with respect 

24 to a grant under this subsection, or may appeal and 

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1 tion involving termination of the center’s grant enti2 tlement, modification of the center’s service area, 

3 termination of a medically underserved population 

4 designation within the center’s service area, disallow5 ance of any grant expenditures, or a significant re6 duction in a center’s grant amount.’’. 

7 SEC. 173. NEGOTIATED RULEMAKING FOR DEVELOPMENT 

8 OF METHODOLOGY AND CRITERIA FOR DES9 IGNATING MEDICALLY UNDERSERVED POPU10 LATIONS AND HEALTH PROFESSIONS SHORT11 AGE AREAS. 

12 (a) ESTABLISHMENT.— 

13 (1) IN GENERAL.—The Secretary of Health and 

14 Human Services (in this section referred to as the 

15 ‘‘Secretary’’) shall establish, through a negotiated 

16 rulemaking process under subchapter 3 of chapter 5 

17 of title 5, United States Code, a comprehensive 

18 methodology and criteria for designation of— 

19 (A) medically underserved populations in 

20 accordance with section 330(b)(3) of the Public 

21 Health Service Act (42 U.S.C. 254b(b)(3)); 

22 (B) health professions shortage areas 

23 under section 332 of the Public Health Service 

24 Act (42 U.S.C. 254e). 


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1 (2) FACTORS TO CONSIDER.—In establishing 

2 the methodology and criteria under paragraph (1), 

3 the Secretary— 

4 (A) shall consult with relevant stakeholders 

5 who will be significantly affected by a rule 

6 (such as national, State and regional organiza7 tions representing affected entities), State 

8 health offices, community organizations, health 

9 centers and other affected entities, and other 

10 interested parties; and 

11 (B) shall take into account— 

12 (i) the timely availability and appro13 priateness of data used to determine a des14 ignation to potential applicants for such 

15 designations; 

16 (ii) the impact of the methodology and 

17 criteria on communities of various types 

18 and on health centers and other safety net 

19 providers; 

20 (iii) the degree of ease or difficulty 

21 that will face potential applicants for such 

22 designations in securing the necessary 

23 data; and 

24 (iv) the extent to which the method25 ology accurately measures various barriers 


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1 that confront individuals and population 

2 groups in seeking health care services. 

3 (b) PUBLICATION OF NOTICE.—In carrying out the 

4 rulemaking process under this subsection, the Secretary 

5 shall publish the notice provided for under section 564(a) 

6 of title 5, United States Code, by not later than 45 days 

7 after the date of the enactment of this Act. 

8 (c) TARGET DATE FOR PUBLICATION OF RULE.—As 

9 part of the notice under subsection (b), and for purposes 

10 of this subsection, the ‘‘target date for publication’’, as 

11 referred to in section 564(a)(5) of title 5, United Sates 

12 Code, shall be July 1, 2010. 

13 (d) APPOINTMENT OF NEGOTIATED RULEMAKING

14 COMMITTEE AND FACILITATOR.—The Secretary shall pro15 vide for— 

16 (1) the appointment of a negotiated rulemaking 

17 committee under section 565(a) of title 5, United 

18 States Code, by not later than 30 days after the end 

19 of the comment period provided for under section 

20 564(c) of such title; and 

21 (2) the nomination of a facilitator under section 

22 566(c) of such title 5 by not later than 10 days after 

23 the date of appointment of the committee. 

24 (e) PRELIMINARY COMMITTEE REPORT.—The nego25 tiated rulemaking committee appointed under subsection 


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1 (d) shall report to the Secretary, by not later than April 

2 1, 2010, regarding the committee’s progress on achieving 

3 a consensus with regard to the rulemaking proceeding and 

4 whether such consensus is likely to occur before one month 

5 before the target date for publication of the rule. If the 

6 committee reports that the committee has failed to make 

7 significant progress toward such consensus or is unlikely 

8 to reach such consensus by the target date, the Secretary 

9 may terminate such process and provide for the publica10 tion of a rule under this section through such other meth11 ods as the Secretary may provide. 

12 (f) FINAL COMMITTEE REPORT.—If the committee 

13 is not terminated under subsection (e), the rulemaking 

14 committee shall submit a report containing a proposed 

15 rule by not later than one month before the target publica16 tion date. 

17 (g) INTERIM FINAL EFFECT.—The Secretary shall 

18 publish a rule under this section in the Federal Register 

19 by not later than the target publication date. Such rule 

20 shall be effective and final immediately on an interim 

21 basis, but is subject to change and revision after public 

22 notice and opportunity for a period (of not less than 90 

23 days) for public comment. In connection with such rule, 

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1 view and approval of applications for such designations 

2 pursuant to such rules and consistent with this section. 

3 (h) PUBLICATION OF RULE AFTER PUBLIC COM4 MENT.—The Secretary shall provide for consideration of 

5 such comments and republication of such rule by not later 

6 than 1 year after the target publication date. 

7 SEC. 174. EQUITY FOR CERTAIN ELIGIBLE SURVIVORS. 

8 (a) REBUTTABLE PRESUMPTION.—Section 411(c)(4) 

9 of the Black Lung Benefits Act (30 U.S.C. 921(c)(4)) is 

10 amended by striking the last sentence. 

11 (b) CONTINUATION OF BENEFITS.—Section 422(l) of 

12 the Black Lung Benefits Act (30 U.S.C. 932(l)) is amend13 ed by striking ‘‘, except with respect to a claim filed under 

14 this part on or after the effective date of the Black Lung 

15 Benefits Amendments of 1981’’. 

16 (c) EFFECTIVE DATE.—The amendments made by 

17 this section shall apply with respect to claims filed under 

18 part B or part C of the Black Lung Benefits Act (30 

19 U.S.C. 921 et seq., 931 et seq.) after January 1, 2005, 

20 that are pending on or after the date of enactment of this 

21 Act. 


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1 SEC. 175. REAUTHORIZATION OF THE WAKEFIELD EMER2 GENCY MEDICAL SERVICES FOR CHILDREN 

3 PROGRAM. 

4 Section 1910 of the Public Health Service Act (42 

5 U.S.C. 300w–9) is amended— 

6 (1) in subsection (a), by striking ‘‘3-year period 

7 (with an optional 4th year’’ and inserting ‘‘4-year 

8 period (with an optional 5th year’’; and 

9 (2) in subsection (d)— 

10 (A) by striking ‘‘and such sums’’ and in11 serting ‘‘such sums’’; and 

12 (B) by inserting before the period the fol13 lowing: ‘‘, $25,000,000 for fiscal year 2010, 

14 $26,250,000 for fiscal year 2011, $27,562,500 

15 for fiscal year 2012, $28,940,625 for fiscal year 

16 2013, and $30,387,656 for fiscal year 2014’’. 

17 SEC. 176. CO-LOCATING PRIMARY AND SPECIALTY CARE IN 

18 COMMUNITY-BASED MENTAL HEALTH SET19 TINGS. 

20 Subpart 3 of part B of title V of the Public Health 

21 Service Act (42 U.S.C. 290bb-31 et seq.) is amended by 

22 adding at the end the following: 

23 ‘‘SEC. 520K. GRANTS FOR CO-LOCATING PRIMARY AND SPE24 CIALTY CARE IN COMMUNITY-BASED MENTAL 

25 HEALTH SETTINGS. 

26 ‘‘(a) DEFINITIONS.—In this section: 


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1 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en2 tity’ means a qualified community mental health 

3 program defined under section 1913(b)(1). 

4 ‘‘(2) SPECIAL POPULATIONS.—The term ‘spe5 cial populations’ refers to the following 3 groups: 

6 ‘‘(A) Children and adolescents with mental 

7 and emotional disturbances who have co-occur8 ring primary care conditions and chronic dis9 eases. 

10 ‘‘(B) Adults with mental illnesses who have 

11 co-occurring primary care conditions and chron12 ic diseases. 

13 ‘‘(C) Older adults with mental illnesses 

14 who have co-occurring primary care conditions 

15 and chronic diseases. 

16 ‘‘(b) PROGRAM AUTHORIZED.—The Secretary, acting 

17 through the Administrator of the Substance Abuse and 

18 Mental Health Services Administration and in coordina19 tion with the Director of the Health Resources and Serv20 ices Administration, shall award grants to eligible entities 

21 to establish demonstration projects for the provision of co22 ordinated and integrated services to special populations 

23 through the co-location of primary and specialty care serv24 ices in community-based mental and behavioral health set25 tings. 


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1 ‘‘(c) APPLICATION.—To be eligible to receive a grant 

2 under this section, an eligible entity shall submit an appli3 cation to the Administrator at such time, in such manner, 

4 and accompanied by such information as the Adminis5 trator may require. Each such application shall include— 

6 ‘‘(1) an assessment of the primary care needs 

7 of the patients served by the eligible entity and a de8 scription of how the eligible entity will address such 

9 needs; and 

10 ‘‘(2) a description of partnerships, cooperative 

11 agreements, or other arrangements with local pri12 mary care providers, including community health 

13 centers, to provide services to special populations. 

14 ‘‘(d) USE OF FUNDS.— 

15 ‘‘(1) IN GENERAL.—For the benefit of special 

16 populations, an eligible entity shall use funds award17 ed under this section for— 

18 ‘‘(A) the provision, by qualified primary 

19 care professionals on a reasonable cost basis, 

20 of— 

21 ‘‘(i) primary care services on site at 

22 the eligible entity; 

23 ‘‘(ii) diagnostic and laboratory serv24 ices; or 


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1 ‘‘(iii) adult and pediatric eye, ear, and 

2 dental screenings; 

3 ‘‘(B) reasonable costs associated with 

4 medically necessary referrals to qualified spe5 cialty care professionals as well as to other co6 ordinators of care or, if permitted by the terms 

7 of the grant, for the provision, by qualified spe8 cialty care professionals on a reasonable cost 

9 basis on site at the eligible entity; 

10 ‘‘(C) information technology required to 

11 accommodate the clinical needs of primary and 

12 specialty care professionals; or 

13 ‘‘(D) facility improvements or modifica14 tions needed to bring primary and specialty 

15 care professionals on site at the eligible entity. 

16 ‘‘(2) LIMITATION.—Not to exceed 15 percent of 

17 grant funds may be used for activities described in 

18 subparagraphs (C) and (D) of paragraph (1). 

19 ‘‘(e) GEOGRAPHIC DISTRIBUTION.—The Secretary 

20 shall ensure that grants awarded under this section are 

21 equitably distributed among the geographical regions of 

22 the United States and between urban and rural popu23 lations. 

24 ‘‘(f) EVALUATION.—Not later than 3 months after a 

25 grant or cooperative agreement awarded under this section 


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1 expires, an eligible entity shall submit to the Secretary the 

2 results of an evaluation to be conducted by the entity con3 cerning the effectiveness of the activities carried out under 

4 the grant or agreement. 

5 ‘‘(g) REPORT.—Not later than 5 years after the date 

6 of enactment of this section, the Secretary shall prepare 

7 and submit to the appropriate committees of Congress a 

8 report that shall evaluate the activities funded under this 

9 section. The report shall include an evaluation of the im10 pact of co-locating primary and specialty care in commu11 nity mental and behavioral health settings on overall pa12 tient health status and recommendations on whether or 

13 not the demonstration program under this section should 

14 be made permanent. 

15 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

16 are authorized to be appropriated to carry out this section, 

17 $50,000,0000 for fiscal year 2010 and such sums as may 

18 be necessary for each of fiscal years 2011 through 2014.’’. 

19 Subtitle F—Making Health Care 

20 More Affordable for Retirees 

21 SEC. 181. REINSURANCE FOR RETIREES. 

22 (a) ADMINISTRATION.— 

23 (1) IN GENERAL.—Not later than 90 days after 

24 the date of enactment of this section, the Secretary 

25 shall establish a temporary reinsurance program to 


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1 provide reimbursement to participating employment2 based plans for a portion of the cost of providing 

3 health benefits to retirees whose primary residence is 

4 located in any State that is not a participating State 

5 or an establishing State (as described in section 

6 3104) for a portion of the cost of providing health 

7 insurance coverage to retirees (and to the eligible 

8 spouses, surviving spouses, and dependents of such 

9 retirees) during the period beginning on the date on 

10 which such program is established and ending on the 

11 date on which such State becomes a participating 

12 State or an establishing State. 

13 (2) REFERENCE.—In this section: 

14 (A) HEALTH BENEFITS.—The term 

15 ‘‘health benefits’’ means medical, surgical, hos16 pital, prescription drug, and such other benefits 

17 as shall be determined by the Secretary, wheth18 er self-funded, or delivered through the pur19 chase of insurance or otherwise. 

20 (B) EMPLOYMENT-BASED PLAN.—The 

21 term ‘‘employment-based plan’’ means a group 

22 health benefits plan that— 

23 (i) is— 

24 (I) maintained by one or more 

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1 ing without limitation any State or 

2 local government or political subdivi3 sion thereof), employee organization, a 

4 voluntary employees’ beneficiary asso5 ciation, or a committee or board of in6 dividuals appointed to administer such 

7 plan; or 

8 (II) a multiemployer plan (as de9 fined in section 3(37) of the Employee 

10 Retirement Income Security Act of 

11 1974); and 

12 (ii) provides health benefits to retir13 ees. 

14 (C) RETIREES.—The term ‘‘retirees’’ 

15 means individuals who are age 55 and older but 

16 are not eligible for coverage under title XVIII 

17 of the Social Security Act, and who are not ac18 tive employees of an employer maintaining , or 

19 currently contributing to, the employment-based 

20 plan or of any employer that has made substan21 tial contributions to fund such plan. 

22 (b) PARTICIPATION.— 

23 (1) EMPLOYMENT-BASED PLAN ELIGIBILITY.— 

24 To be eligible to participate in the program estab25 lished under this section, an employment-based plan 


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1 (as defined in subsection (a)(2) and referred to in 

2 this section as a ‘‘participating employment-based 

3 plan’’ shall— 

4 (A) provide employment-based health plan 

5 benefits; and 

6 (B) submit to the Secretary an application 

7 for participation in the program, at such time, 

8 in such manner, and containing such informa9 tion as the Secretary shall require. 

10 (2) APPROPRIATE EMPLOYMENT-BASED

11 HEALTH BENEFITS.—Appropriate employment-based 

12 health benefits described in this paragraph shall— 

13 (A) meet the requirements established 

14 under section 3103(a)(1)(B); 

15 (B) implement programs and procedures to 

16 generate cost-savings with respect to partici17 pants with chronic and high-cost conditions; 

18 (C) provide documentation of the actual 

19 cost of medical claims involved; and 

20 (D) be certified as appropriate by the Sec21 retary. 

22 (c) PAYMENTS.— 

23 (1) SUBMISSION OF CLAIMS.— 

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1 bursement to the Secretary which shall contain 

2 documentation of the actual costs of the items 

3 and services for which each claim is being sub4 mitted. 

5 (B) BASIS FOR CLAIMS.—Claims submitted 

6 under paragraph (1) shall be based on the ac7 tual amount expended by the participating em8 ployment-based plan involved within the plan 

9 year for the appropriate employment-based 

10 health benefits provided to a retiree or the 

11 spouse, surviving spouse, or dependent of such 

12 retiree. In determining the amount of a claim 

13 for purposes of this subsection, the partici14 pating employment-based plan shall take into 

15 account any negotiated price concessions (such 

16 as discounts, direct or indirect subsidies, re17 bates, and direct or indirect remunerations) ob18 tained by such plan with respect to such health 

19 benefit. For purposes of determining the 

20 amount of any such claim, the costs paid by the 

21 retiree or the retiree’s spouse, surviving spouse, 

22 or dependent in the form of deductibles, co-pay23 ments, or co-insurance shall be included in the 

24 amounts paid by the participating employment25 based plan. 


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1 (2) PROGRAM PAYMENTS.—If the Secretary de2 termines that a participating employment-based plan 

3 has submitted a valid claim under paragraph (1), 

4 the Secretary shall reimburse such plan for 80 per5 cent of that portion of the costs attributable to such 

6 claim that exceed $15,000, subject to the limits con7 tained in paragraph (3). 

8 (3) LIMIT.—To be eligible for reimbursement 

9 under the program, a claim submitted by a partici10 pating employment-based plan shall not be less than 

11 $15,000 nor greater than $90,000. Such amounts 

12 shall be adjusted each fiscal year based on the per13 centage increase in the Medical Care Component of 

14 the Consumer Price Index for all urban consumers 

15 (rounded to the nearest multiple of $1,000) for the 

16 year involved. 

17 (4) USE OF PAYMENTS.—Amounts paid to a 

18 participating employment-based plan under this sub19 section shall be used to lower costs for the plan. 

20 Such payments may be used to reduce premium 

21 costs for an entity described in subsection 

22 (a)(2)(B)(i) or to reduce premium contributions, co23 payments, deductibles, co-insurance, or other out-of24 pocket costs for plan participants. Such payments 

25 shall not be used as general revenues for an entity 


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1 described in subsection (a)(2)(B)(i). The Secretary 

2 shall develop a mechanism to monitor the appro3 priate use of such payments by such entities. 

4 (5) PAYMENTS NOT TREATED AS INCOME.— 

5 Payments received under this subsection shall not be 

6 included in determining the gross income of an enti7 ty described in subsection (a)(2)(B)(i) that is main8 taining or currently contributing to a participating 

9 employment-based plan. 

10 (6) APPEALS.—The Secretary shall establish— 

11 (A) an appeals process to permit partici12 pating employment-based plans to appeal a de13 termination of the Secretary with respect to 

14 claims submitted under this section; and 

15 (B) procedures to protect against fraud, 

16 waste, and abuse under the program. 

17 (d) AUDITS.—The Secretary shall conduct annual au18 dits of claims data submitted by participating employ19 ment-based plans under this section to ensure that such 

20 plans are in compliance with the requirements of this sec21 tion. 

22 (e) RETIREE RESERVE TRUST FUND.— 

23 (1) ESTABLISHMENT OF TRUST FUND.— 

24 (A) IN GENERAL.—There is established in 

25 the Treasury of the United States a trust fund 


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1 to be known as the ‘‘Retiree Reserve Trust 

2 Fund’’ (referred to in this section as the ‘‘Trust 

3 Fund’’), that shall consist of such amounts as 

4 may be appropriated or credited to the Trust 

5 Fund as provided for in this subsection to en6 able the Secretary to carry out the program 

7 under this section. Such amounts shall remain 

8 available until expended. 

9 (B) FUNDING.—There are hereby appro10 priated to the Trust Fund, out of any moneys 

11 in the Treasury not otherwise appropriated an 

12 amount requested by the Secretary of Health 

13 and Human Services as necessary to carry out 

14 this section, except that the total of all such 

15 amounts requested shall not exceed 

16 $10,000,000,000. 

17 (C) APPROPRIATIONS FROM THE TRUST

18 FUND.—Amounts in the Trust Fund may be 

19 appropriated to provide funding to carry out 

20 this program under this section 

21 (2) USE OF TRUST FUND.—The Secretary shall 

22 use amounts contained in the Trust Fund to carry 

23 out the program under this section. 

24 (3) LIMITATIONS.—The Secretary has the au25 thority to stop taking applications for participation 


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1 in the program to comply with the funding limit pro2 vided for in paragraph (1)(B). 

3 Subtitle G—Improving the Use of 

4 Health Information Technology 

5 for Enrollment; Miscellaneous 

6 Provisions 

7 SEC. 185. HEALTH INFORMATION TECHNOLOGY ENROLL8 MENT STANDARDS AND PROTOCOLS. 

9 Title XXX of the Public Health Service Act (42 

10 U.S.C. 300jj et seq.) is amended by adding at the end 

11 the following: 

12 ‘‘Subtitle C—Other Provisions 

13 ‘‘SEC. 3021. HEALTH INFORMATION TECHNOLOGY ENROLL14 MENT STANDARDS AND PROTOCOLS. 

15 ‘‘(a) IN GENERAL.— 

16 ‘‘(1) STANDARDS AND PROTOCOLS.—Not later 

17 than 180 days after the date of enactment of this 

18 title, the Secretary, in consultation with the HIT 

19 Policy Committee and the HIT Standards Com20 mittee, shall develop interoperable and secure stand21 ards and protocols that facilitate enrollment of indi22 viduals in Federal and State health and human serv23 ices programs, as determined by the Secretary. 

24 ‘‘(2) METHODS.—The Secretary shall facilitate 

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1 mined appropriate by the Secretary, which shall in2 clude providing individuals and third parties author3 ized by such individuals and their designees notifica4 tion of eligibility and verification of eligibility re5 quired under such programs. 

6 ‘‘(b) CONTENT.—The standards and protocols for 

7 electronic enrollment in the Federal and State programs 

8 described in subsection (a) shall allow for the following: 

9 ‘‘(1) Electronic matching against existing Fed10 eral and State data, including vital records, employ11 ment history, enrollment systems, tax records, and 

12 other data determined appropriate by the Secretary 

13 to serve as evidence of eligibility and in lieu of 

14 paper-based documentation. 

15 ‘‘(2) Simplification and submission of electronic 

16 documentation, digitization of documents, and sys17 tems verification of eligibility. 

18 ‘‘(3) Reuse of stored eligibility information (in19 cluding documentation) to assist with retention of el20 igible individuals. 

21 ‘‘(4) Capability for individuals to apply, recer22 tify and manage their eligibility information online, 

23 including at home, at points of service, and other 

24 community-based locations. 


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1 ‘‘(5) Ability to expand the enrollment system to 

2 integrate new programs, rules, and functionalities, to 

3 operate at increased volume, and to apply stream4 lined verification and eligibility processes to other 

5 Federal and State programs, as appropriate. 

6 ‘‘(6) Notification of eligibility, recertification, 

7 and other needed communication regarding eligi8 bility, which may include communication via email 

9 and cellular phones. 

10 ‘‘(7) Other functionalities necessary to provide 

11 eligibles with streamlined enrollment process. 

12 ‘‘(c) APPROVAL AND NOTIFICATION.—With respect 

13 to any standard or protocol developed under subsection (a) 

14 that has been approved by the HIT Policy Committee and 

15 the HIT Standards Committee, the Secretary— 

16 ‘‘(1) shall notify States of such standards or 

17 protocols; and 

18 ‘‘(2) may require, as a condition of receiving 

19 Federal funds for the health information technology 

20 investments, that States or other entities incorporate 

21 such standards and protocols into such investments. 

22 ‘‘(d) GRANTS FOR IMPLEMENTATION OF APPRO23 PRIATE ENROLLMENT HIT.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall award 

25 grant to eligible entities to develop new, and adapt 


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1 existing, technology systems to implement the HIT 

2 enrollment standards and protocols developed under 

3 subsection (a) (referred to in this subsection as ‘ap4 propriate HIT technology’). 

5 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible for a 

6 grant under this subsection, an entity shall— 

7 ‘‘(A) be a State, political subdivision of a 

8 State, or a local governmental entity; and 

9 ‘‘(B) submit to the Secretary an applica10 tion at such time, in such manner, and con11 taining— 

12 ‘‘(i) a plan to adopt and implement 

13 appropriate enrollment technology that in14 cludes— 

15 ‘‘(I) proposed reduction in main16 tenance costs of technology systems; 

17 ‘‘(II) elimination or updating of 

18 legacy systems; and 

19 ‘‘(III) demonstrated collaboration 

20 with other entities that may receive a 

21 grant under this section that are lo22 cated in the same State, political sub23 division, or locality; 

24 ‘‘(ii) an assurance that the entity will 

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1 nology in accordance with paragraph (4); 

2 and 

3 ‘‘(iii) such other information as the 

4 Secretary may require. 

5 ‘‘(3) SHARING.— 

6 ‘‘(A) IN GENERAL.—The Secretary shall 

7 ensure that appropriate enrollment HIT adopt8 ed under grants under this subsection is made 

9 available to other qualified State, qualified po10 litical subdivisions of a State, or other appro11 priate qualified entities (as described in sub12 paragraph (B)) at no cost. 

13 ‘‘(B) QUALIFIED ENTITIES.—The Sec14 retary shall determine what entities are quali15 fied to receive enrollment HIT under subpara16 graph (A), taking into consideration the rec17 ommendations of the HIT Policy Committee 

18 and the HIT Standards Committee.’’. 

19 SEC. 186. RULE OF CONSTRUCTION REGARDING HAWAII’S 

20 PREPAID HEALTH CARE ACT. 

21 Nothing in this title (or an amendment made by this 

22 title) shall be construed to modify or limit the application 

23 of the exemption for Hawaii’s Prepaid Health Care Act 

24 (Haw. Rev. Stat. §§ 393-1 et seq.) as provided for under 


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1 section 514(b)(5) of the Employee Retirement Income Se2 curity Act of 1974 (29 U.S.C. 1144(b)(5)). 

3 SEC. 187. KEY NATIONAL INDICATORS. 

4 (a) DEFINITIONS.—In this section: 

5 (1) ACADEMY.—The term ‘‘Academy’’ means 

6 the National Academy of Sciences. 

7 (2) COMMISSION.—The term ‘‘Commission’’ 

8 means the Commission on Key National Indicators 

9 established under subsection (b). 

10 (3) INSTITUTE.—The term ‘‘Institute’’ means a 

11 Key National Indicators Institute as designated 

12 under subsection (c)(3). 

13 (b) COMMISSION ON KEY NATIONAL INDICATORS.— 

14 (1) ESTABLISHMENT.—There is established a 

15 ‘‘Commission on Key National Indicators’’. 

16 (2) MEMBERSHIP.— 

17 (A) NUMBER AND APPOINTMENT.—The 

18 Commission shall be composed of 8 members, to 

19 be appointed equally by the majority and mi20 nority leaders of the Senate and the Speaker 

21 and minority leader of the House of Represent22 atives. 

23 (B) PROHIBITED APPOINTMENTS.—Mem24 bers of the Commission shall not include MemVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00213 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 bers of Congress or other elected Federal, 

2 State, or local government officials. 

3 (C) QUALIFICATIONS.—In making appoint4 ments under subparagraph (A), the majority 

5 and minority leaders of the Senate and the 

6 Speaker and minority leader of the House of 

7 Representatives shall appoint individuals who 

8 have shown a dedication to improving civic dia9 logue and decision-making through the wide use 

10 of scientific evidence and factual information. 

11 (D) PERIOD OF APPOINTMENT.—Each 

12 member of the Commission shall be appointed 

13 for a 2-year term, except that 1 initial appoint14 ment shall be for 3 years. Any vacancies shall 

15 not affect the power and duties of the Commis16 sion but shall be filled in the same manner as 

17 the original appointment and shall last only for 

18 the remainder of that term. 

19 (E) DATE.—Members of the Commission 

20 shall be appointed by not later than 30 days 

21 after the date of enactment of this Act. 

22 (F) INITIAL ORGANIZING PERIOD.—–Not 

23 later than 60 days after the date of enactment 

24 of this Act, the Commission shall develop and 


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1 implement a schedule for completion of the re2 view and reports required under subsection (d). 

3 (G) CO-CHAIRPERSONS.—The Commission 

4 shall select 2 Co-Chairpersons from among its 

5 members. 

6 (c) DUTIES OF THE COMMISSION.— 

7 (1) IN GENERAL.—The Commission shall— 

8 (A) conduct comprehensive oversight of a 

9 newly established key national indicators system 

10 consistent with the purpose described in this 

11 subsection; 

12 (B) make recommendations on how to im13 prove the key national indicators system; 

14 (C) coordinate with Federal Government 

15 users and information providers to assure ac16 cess to relevant and quality data; and 

17 (D) enter into contracts with the Academy. 

18 (2) REPORTS.— 

19 (A) ANNUAL REPORT TO CONGRESS.—Not 

20 later than 1 year after the selection of the 2 

21 Co-Chairpersons of the Commission, and each 

22 subsequent year thereafter, the Commission 

23 shall prepare and submit to the appropriate 

24 Committees of Congress and the President a re25 port that contains a detailed statement of the 


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1 recommendations, findings, and conclusions of 

2 the Commission on the activities of the Acad3 emy and a designated Institute related to the 

4 establishment of a Key National Indicator Sys5 tem. 

6 (B) ANNUAL REPORT TO THE ACADEMY.— 

7 (i) IN GENERAL.—Not later than 6 

8 months after the selection of the 2 Co9 Chairpersons of the Commission, and each 

10 subsequent year thereafter, the Commis11 sion shall prepare and submit to the Acad12 emy and a designated Institute a report 

13 making recommendations concerning po14 tential issue areas and key indicators to be 

15 included in the Key National Indicators. 

16 (ii) LIMITATION.—The Commission 

17 shall not have the authority to direct the 

18 Academy or, if established, the Institute, 

19 to adopt, modify, or delete any key indica20 tors. 

21 (3) CONTRACT WITH THE NATIONAL ACADEMY

22 OF SCIENCES.—– 

23 (A) IN GENERAL.—–As soon as practicable 

24 after the selection of the 2 Co-Chairpersons of 

25 the Commission, the Co-Chairpersons shall 


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1 enter into an arrangement with the National 

2 Academy of Sciences under which the Academy 

3 shall— 

4 (i) review available public and private 

5 sector research on the selection of a set of 

6 key national indicators; 

7 (ii) determine how best to establish a 

8 key national indicator system for the 

9 United States, by either creating its own 

10 institutional capability or designating an 

11 independent private nonprofit organization 

12 as an Institute to implement a key national 

13 indicator system; 

14 (iii) if the Academy designates an 

15 independent Institute under clause (ii), 

16 provide scientific and technical advice to 

17 the Institute and create an appropriate 

18 governance mechanism that balances Acad19 emy involvement and the independence of 

20 the Institute; and 

21 (iv) provide an annual report to the 

22 Commission addressing scientific and tech23 nical issues related to the key national in24 dicator system and, if established, the InVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00217 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 stitute, and governance of the Institute’s 

2 budget and operations. 

3 (B) PARTICIPATION.—In executing the ar4 rangement under subparagraph (A), the Na5 tional Academy of Sciences shall convene a 

6 multi-sector, multi-disciplinary process to define 

7 major scientific and technical issues associated 

8 with developing, maintaining, and evolving a 

9 Key National Indicator System and, if an Insti10 tute is established, to provide it with scientific 

11 and technical advice. 

12 (C) ESTABLISHMENT OF A KEY NATIONAL

13 INDICATOR SYSTEM.— 

14 (i) IN GENERAL.—In executing the ar15 rangement under subparagraph (A), the 

16 National Academy of Sciences shall enable 

17 the establishment of a key national indi18 cator system by— 

19 (I) creating its own institutional 

20 capability; or 

21 (II) partnering with an inde22 pendent private nonprofit organization 

23 as an Institute to implement a key na24 tional indicator system. 


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1 (ii) INSTITUTE.—If the Academy des2 ignates an Institute under clause (i)(II), 

3 such Institute shall be a non-profit entity 

4 (as defined for purposes of section 

5 501(c)(3) of the Internal Revenue Code of 

6 1986) with an educational mission, a gov7 ernance structure that emphasizes inde8 pendence, and characteristics that make 

9 such entity appropriate for establishing a 

10 key national indicator system. 

11 (iii) RESPONSIBILITIES.—Either the 

12 Academy or the Institute designated under 

13 clause (i)(II) shall be responsible for the 

14 following: 

15 (I) Identifying and selecting issue 

16 areas to be represented by the key na17 tional indicators. 

18 (II) Identifying and selecting the 

19 measures used for key national indica20 tors within the issue areas under sub21 clause (I). 

22 (III) Identifying and selecting 

23 data to populate the key national indi24 cators described under subclause (II). 


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1 (IV) Designing, publishing, and 

2 maintaining a public website that con3 tains a freely accessible database al4 lowing public access to the key na5 tional indicators. 

6 (V) Developing a quality assur7 ance framework to ensure rigorous 

8 and independent processes and the se9 lection of quality data. 

10 (VI) Developing a budget for the 

11 construction and management of a 

12 sustainable, adaptable, and evolving 

13 key national indicator system that re14 flects all Commission funding of 

15 Academy and, if an Institute is estab16 lished, Institute activities. 

17 (VII) Reporting annually to the 

18 Commission regarding its selection of 

19 issue areas, key indicators, data, and 

20 progress toward establishing a web-ac21 cessible database. 

22 (VIII) Responding directly to the 

23 Commission in response to any Com24 mission recommendations and to the 


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1 Academy regarding any inquiries by 

2 the Academy. 

3 (iv) GOVERNANCE.—Upon the estab4 lishment of a key national indicator sys5 tem, the Academy shall create an appro6 priate governance mechanism that incor7 porates advisory and control functions. If 

8 an Institute is designated under clause 

9 (i)(II), the governance mechanism shall 

10 balance appropriate Academy involvement 

11 and the independence of the Institute. 

12 (v) MODIFICATION AND CHANGES.— 

13 The Academy shall retain the sole discre14 tion, at any time, to alter its approach to 

15 the establishment of a key national indi16 cator system or, if an Institute is des17 ignated under clause (i)(II), to alter any 

18 aspect of its relationship with the Institute 

19 or to designate a different non-profit entity 

20 to serve as the Institute. 

21 (vi) CONSTRUCTION.—Nothing in this 

22 section shall be construed to limit the abil23 ity of the Academy or the Institute des24 ignated under clause (i)(II) to receive pri25 vate funding for activities related to the esVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00221 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 tablishment of a key national indicator sys2 tem. 

3 (D) ANNUAL REPORT.—As part of the ar4 rangement under subparagraph (A), the Na5 tional Academy of Sciences shall, not later than 

6 270 days after the date of enactment of this 

7 Act, and annually thereafter, submit to the Co8 Chairpersons of the Commission a report that 

9 contains the findings and recommendations of 

10 the Academy. 

11 (d) GOVERNMENT ACCOUNTABILITY OFFICE STUDY

12 AND REPORT.— 

13 (1) GAO STUDY.—The Comptroller General of 

14 the United States shall conduct a study of previous 

15 work conducted by all public agencies, private orga16 nizations, or foreign countries with respect to best 

17 practices for a key national indicator system. The 

18 study shall be submitted to the appropriate author19 izing committees of Congress. 

20 (2) GAO FINANCIAL AUDIT.—If an Institute is 

21 established under this section, the Comptroller Gen22 eral shall conduct an annual audit of the financial 

23 statements of the Institute, in accordance with gen24 erally accepted government auditing standards and 

25 submit a report on such audit to the Commission 


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1 and the appropriate authorizing committees of Con2 gress. 

3 (3) GAO PROGRAMMATIC REVIEW.—The Comp4 troller General of the United States shall conduct 

5 programmatic assessments of the Institute estab6 lished under this section as determined necessary by 

7 the Comptroller General and report the findings to 

8 the Commission and to the appropriate authorizing 

9 committees of Congress. 

10 (e) AUTHORIZATION OF APPROPRIATIONS.— 

11 (1) IN GENERAL.—–There are authorized to be 

12 appropriated to carry out the purposes of this sec13 tion, $10,000,000 for fiscal year 2010, and 

14 $7,500,000 for each of fiscal year 2011 through 

15 2018. 

16 (2) AVAILABILITY.—–Amounts appropriated 

17 under paragraph (1) shall remain available until ex18 pended. 

19 SEC. 188. STUDY AND REPORT ON RATES OF PREVENTABLE 

20 DISEASES IN NEW MEDICARE ENROLLEES. 

21 (a) STUDY.— 

22 (1) IN GENERAL.—The Comptroller General of 

23 the United States (in this section referred to as the 

24 ‘‘Comptroller General’’) shall conduct a study on— 


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1 (A) whether applicable new Medicare en2 rollees exhibit higher than expected rates of 

3 preventable disease when compared to the en4 tire population of new Medicare enrollees or an5 other appropriate statistical baseline; and 

6 (B) if applicable new Medicare enrollees 

7 exhibit such a higher than expected rate of pre8 ventable disease, whether such rate is related to 

9 the failure of the enrollee’s previous private 

10 health insurance issuer to promote, cover, or 

11 adequately pay for preventive health benefits. 

12 (2) APPLICABLE NEW MEDICARE ENROLLEE.— 

13 In this section, the term ‘‘applicable new Medicare 

14 enrollee’’ means an individual— 

15 (A) who is entitled to, or enrolled for, ben16 efits under part A of title XVII of the Social 

17 Security Act (42 U.S.C. 1395 et seq.) or en18 rolled for benefits under part B of such title on 

19 or after the date of enactment of this Act; and 

20 (B) who was covered by private health in21 surance or Medicaid or other Federal Govern22 ment health programs (as of the day before the 

23 date of such entitlement or enrollment). 

24 (b) REPORT.—Not later than 3 years after the date 

25 on which at least 5 Gateways under title XXXI of the 


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1 Public Health Service Act, as added by section 142, are 

2 operating in the United States, the Comptroller General 

3 shall submit to Congress a report containing the results 

4 of the study conducted under subsection (a), together with 

5 recommendations for such legislation and administrative 

6 action as the Comptroller General determines appropriate. 

7 SEC. 189. TRANSPARENCY IN GOVERNMENT. 

8 Not later than 30 days after the date of enactment 

9 of this Act, the Secretary of Health and Human Services 

10 shall publish on the Internet website of the Department 

11 of Health and Human Services, a list of all of the authori12 ties provided to the Secretary under this Act (and the 

13 amendments made by this Act). 

14 SEC. 189A. PRESERVING THE SOLVENCY OF MEDICARE AND 

15 SOCIAL SECURITY. 

16 Nothing in this Act (or an amendment made by this 

17 Act) shall be carried out in a manner that threatens the 

18 solvency of Medicare or Social Security programs. 

19 SEC. 189B. PROHIBITION AGAINST DISCRIMINATION ON AS20 SISTED SUICIDE. 

21 (a) IN GENERAL.—The Federal Government, and 

22 any State or local government or health care provider that 

23 receives Federal financial assistance under this Act (or 

24 under an amendment made by this Act) or any health plan 

25 created under this Act (or under an amendment made by 


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1 this Act), may not subject an individual or institutional 

2 health care entity to discrimination on the basis that the 

3 entity does not provide any health care item or service fur4 nished for the purpose of causing, or for the purpose of 

5 assisting in causing, the death of any individual, such as 

6 by assisted suicide, euthanasia, or mercy killing. 

7 (b) DEFINITION.—In this section, the term ‘‘health 

8 care entity’’ includes an individual physician or other 

9 health care professional, a hospital, a provider-sponsored 

10 organization, a health maintenance organization, a health 

11 insurance plan, or any other kind of health care facility, 

12 organization, or plan. 

13 (c) CONSTRUCTION AND TREATMENT OF CERTAIN

14 SERVICES.—Nothing in subsection (a) shall be construed 

15 to apply to or to affect any limitation relating to— 

16 (1) the withholding or withdrawing of medical 

17 treatment or medical care; 

18 (2) the withholding or withdrawing of nutrition 

19 or hydration; 

20 (3) abortion; or 

21 (4) the use of an item, good, benefit, or service 

22 furnished for the purpose of alleviating pain or dis23 comfort, even if such use may increase the risk of 

24 death, so long as such item, good, benefit, or service 

25 is not also furnished for the purpose of causing, or 


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1 the purpose of assisting in causing, death, for any 

2 reason. 

3 (d) ADMINISTRATION.—The Office for Civil Rights of 

4 the Department of Health and Human Services is des5 ignated to receive complaints of discrimination based on 

6 this section. 

7 SEC. 189C. ACCESS TO THERAPIES. 

8 Notwithstanding any other provision of the Afford9 able Health Choices Act, the Secretary of Health and 

10 Human Services shall not promulgate any regulation 

11 that— 

12 (1) creates any unreasonable barriers to the 

13 ability of individuals to obtain appropriate medical 

14 care; 

15 (2) impedes timely access to health care serv16 ices; 

17 (3) interferes with communications regarding a 

18 full range of treatment options between the patient 

19 and the provider; 

20 (4) restricts the ability of health care providers 

21 to provide full disclosure of all relevant information 

22 to patients making health care decisions; 

23 (5) violates the principles of informed consent 

24 and the ethical standards of health care profes25 sionals; or 


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1 (6) limits the availability of health care treat2 ment for the full duration of a patient’s medical 

3 needs. 

4 SEC. 189D. FREEDOM NOT TO PARTICIPATE IN FEDERAL 

5 HEALTH INSURANCE PROGRAMS. 

6 No individual, company, business, nonprofit entity, or 

7 health insurer offering group or individual health insur8 ance shall be required to participate in any Federal health 

9 insurance program created under this Act (or any amend10 ments made by this Act), or in any Federal health insur11 ance program expanded by this Act (or any such amend12 ments), and there shall be no penalty or fine imposed upon 

13 any such insurer for choosing not to participate in such 

14 programs. 

15 Subtitle H—CLASS Act 

16 SEC. 190. SHORT TITLE OF SUBTITLE. 

17 This subtitle may be cited as the ‘‘Community Living 

18 Assistance Services and Supports Act’’ or the ‘‘CLASS 

19 Act’’. 

20 SEC. 191. ESTABLISHMENT OF NATIONAL VOLUNTARY IN21 SURANCE PROGRAM FOR PURCHASING COM22 MUNITY LIVING ASSISTANCE SERVICES AND 

23 SUPPORT. 

24 (a) ESTABLISHMENT OF CLASS PROGRAM.— 


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1 (1) IN GENERAL.—The Public Health Service 

2 Act (42 U.S.C. 201 et seq.), as amended by section 

3 143, is amended by adding at the end the following: 

4 ‘‘TITLE XXXII—COMMUNITY LIV5 ING ASSISTANCE SERVICES 

6 AND SUPPORTS 

7 ‘‘SEC. 3201. PURPOSE. 

8 ‘‘The purpose of this title is to establish a national 

9 voluntary insurance program for purchasing community 

10 living assistance services and supports in order to— 

11 ‘‘(1) provide individuals with functional limita12 tions with tools that will allow them to maintain 

13 their personal and financial independence and live in 

14 the community through a new financing strategy for 

15 community living assistance services and supports; 

16 ‘‘(2) establish an infrastructure that will help 

17 address the Nation’s community living assistance 

18 services and supports needs; 

19 ‘‘(3) alleviate burdens on family caregivers; and 

20 ‘‘(4) address institutional bias by providing a fi21 nancing mechanism that supports personal choice 

22 and independence to live in the community. 

23 ‘‘SEC. 3202. DEFINITIONS. 

24 ‘‘In this title: 


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1 ‘‘(1) ACTIVE ENROLLEE.—The term ‘active en2 rollee’ means an individual who is enrolled in the 

3 CLASS program in accordance with section 3204 

4 and who has paid any premiums due to maintain 

5 such enrollment. 

6 ‘‘(2) ACTIVELY EMPLOYED.—The term ‘actively 

7 employed’ means an individual who— 

8 ‘‘(A) is reporting for work at the individ9 ual’s usual place of employment or at another 

10 location to which the individual is required to 

11 travel because of the individual’s employment 

12 (or in the case of an individual who is a mem13 ber of the uniformed services, is on active duty 

14 and is physically able to perform the duties of 

15 the individual’s position); and 

16 ‘‘(B) is able to perform all the usual and 

17 customary duties of the individual’s employment 

18 on the individual’s regular work schedule. 

19 ‘‘(3) ACTIVITIES OF DAILY LIVING.—The term 

20 ‘activities of daily living’ means each of the following 

21 activities specified in section 7702B(c)(2)(B) of the 

22 Internal Revenue Code of 1986: 

23 ‘‘(A) Eating. 

24 ‘‘(B) Toileting. 

25 ‘‘(C) Transferring. 


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1 ‘‘(D) Bathing. 

2 ‘‘(E) Dressing. 

3 ‘‘(F) Continence. 

4 ‘‘(4) CLASS PROGRAM.—The term ‘CLASS 

5 program’ means the program established under this 

6 title. 

7 ‘‘(5) DISABILITY DETERMINATION SERVICE.— 

8 The term ‘Disability Determination Service’ means, 

9 with respect to each State, the entity that has an 

10 agreement with the Commissioner of Social Security 

11 to make disability determinations for purposes of 

12 title II or XVI of the Social Security Act (42 U.S.C. 

13 401 et seq., 1381 et seq.). 

14 ‘‘(6) ELIGIBLE BENEFICIARY.— 

15 ‘‘(A) IN GENERAL.—The term ‘eligible 

16 beneficiary’ means any individual who is an ac17 tive enrollee in the CLASS program and, as of 

18 the date described in subparagraph (B)— 

19 ‘‘(i) has paid premiums for enrollment 

20 in such program for at least 60 months; 

21 ‘‘(ii) has earned, for each calendar 

22 year that occurs during the first 60 

23 months for which the individual has paid 

24 premiums for enrollment in the program, 

25 at least an amount equal to the amount of 


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1 wages and self-employment income which 

2 an individual must have in order to be 

3 credited with a quarter of coverage under 

4 section 213(d) of the Social Security Act 

5 for that year; and 

6 ‘‘(iii) has paid premiums for enroll7 ment in such program for at least 24 con8 secutive months, if a lapse in premium 

9 payments of more than 3 months has oc10 curred during the period that begins on the 

11 date of the individual’s enrollment and 

12 ends on the date of such determination. 

13 ‘‘(B) DATE DESCRIBED.—For purposes of 

14 subparagraph (A), the date described in this 

15 subparagraph is the date on which the indi16 vidual is determined to have a functional limita17 tion described in section 3203(a)(1)(C) that is 

18 expected to last for a continuous period of more 

19 than 90 days. 

20 ‘‘(C) REGULATIONS.—The Secretary shall 

21 promulgate regulations specifying exceptions to 

22 the minimum earnings requirements under sub23 paragraph (A)(ii) for purposes of being consid24 ered an eligible beneficiary for certain popu25 lations. 


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1 ‘‘(7) HOSPITAL; NURSING FACILITY; INTER2 MEDIATE CARE FACILITY FOR THE MENTALLY RE3 TARDED; INSTITUTION FOR MENTAL DISEASES.— 

4 The terms ‘hospital’, ‘nursing facility’, ‘intermediate 

5 care facility for the mentally retarded’, and ‘institu6 tion for mental diseases’ have the meanings given 

7 such terms for purposes of Medicaid. 

8 ‘‘(8) CLASS INDEPENDENCE ADVISORY COUN9 CIL.—The term ‘CLASS Independence Advisory 

10 Council’ or ‘Council’ means the Advisory Council es11 tablished under section 3207 to advise the Secretary. 

12 ‘‘(9) CLASS INDEPENDENCE BENEFIT PLAN.— 

13 The term ‘CLASS Independence Benefit Plan’ 

14 means the benefit plan developed and designated by 

15 the Secretary in accordance with section 3203. 

16 ‘‘(10) CLASS INDEPENDENCE FUND.—The 

17 term ‘CLASS Independence Fund’ or ‘Fund’ means 

18 the fund established under section 3206. 

19 ‘‘(11) MEDICAID.—The term ‘Medicaid’ means 

20 the program established under title XIX of the So21 cial Security Act (42 U.S.C. 1396 et seq.). 

22 ‘‘(12) PROTECTION AND ADVOCACY SYSTEM.— 

23 The term ‘Protection and Advocacy System’ means 

24 the system for each State established under section 


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1 143 of the Developmental Disabilities Assistance 

2 and Bill of Rights Act of 2000 (42 U.S.C. 15043). 

3 ‘‘SEC. 3203. CLASS INDEPENDENCE BENEFIT PLAN. 

4 ‘‘(a) PROCESS FOR DEVELOPMENT.— 

5 ‘‘(1) IN GENERAL.—The Secretary, in consulta6 tion with appropriate actuaries and other experts, 

7 shall develop at least 3 actuarially sound benefit 

8 plans as alternatives for consideration for designa9 tion by the Secretary as the CLASS Independence 

10 Benefit Plan under which eligible beneficiaries shall 

11 receive benefits under this title. Each of the plan al12 ternatives developed shall be designed to provide eli13 gible beneficiaries with the benefits described in sec14 tion 3205 consistent with the following require15 ments: 

16 ‘‘(A) PREMIUMS.—Beginning with the first 

17 year of the CLASS program, and for each year 

18 thereafter, the Secretary shall establish all pre19 miums to be paid by enrollees for the year 

20 based on an actuarial analysis of the 75-year 

21 costs of the program that ensures solvency 

22 throughout such 75-year period. 

23 ‘‘(B) VESTING PERIOD.—A 5-year vesting 

24 period for eligibility for benefits. 


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1 ‘‘(C) BENEFIT TRIGGERS.—A benefit trig2 ger for provision of benefits that requires a de3 termination that an individual has a functional 

4 limitation, as certified by a licensed health care 

5 practitioner, described in any of the following 

6 clauses that is expected to last for a continuous 

7 period of more than 90 days: 

8 ‘‘(i) The individual is determined to 

9 be unable to perform at least the minimum 

10 number (which may be 2 or 3) of activities 

11 of daily living as are required under the 

12 plan for the provision of benefits without 

13 substantial assistance (as defined by the 

14 Secretary) from another individual. 

15 ‘‘(ii) The individual requires substan16 tial supervision to protect the individual 

17 from threats to health and safety due to 

18 substantial cognitive impairment. 

19 ‘‘(iii) The individual has a level of 

20 functional limitation similar (as determined 

21 under regulations prescribed by the Sec22 retary) to the level of functional limitation 

23 described in clause (i) or (ii). 

24 ‘‘(D) CASH BENEFIT.—Payment of a cash 

25 benefit that satisfies the following requirements: 


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1 ‘‘(i) MINIMUM REQUIRED AMOUNT.— 

2 The benefit amount provides an eligible 

3 beneficiary with not less than an average 

4 of $50 per day (as determined based on 

5 the reasonably expected distribution of 

6 beneficiaries receiving benefits at various 

7 benefit levels). 

8 ‘‘(ii) AMOUNT SCALED TO FUNC9 TIONAL ABILITY.—The benefit amount is 

10 varied based on a scale of functional abil11 ity, with not less than 2, and not more 

12 than 6, benefit level amounts. 

13 ‘‘(iii) DAILY OR WEEKLY.—The ben14 efit is paid on a daily or weekly basis. 

15 ‘‘(iv) NO LIFETIME OR AGGREGATE

16 LIMIT.—The benefit is not subject to any 

17 lifetime or aggregate limit. 

18 ‘‘(E) COORDINATION WITH SUPPLE19 MENTAL COVERAGE OBTAINED THROUGH THE

20 EXCHANGE.—The benefits allow for coordina21 tion with any supplemental coverage purchased 

22 through a Gateway established under section 

23 3101. 


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1 ‘‘(2) REVIEW AND RECOMMENDATION BY THE

2 CLASS INDEPENDENCE ADVISORY COUNCIL.—The 

3 CLASS Independence Advisory Council shall— 

4 ‘‘(A) evaluate the alternative benefit plans 

5 developed under paragraph (1); and 

6 ‘‘(B) recommend for designation as the 

7 CLASS Independence Benefit Plan for offering 

8 to the public the plan that the Council deter9 mines best balances price and benefits to meet 

10 enrollees’ needs in an actuarially sound manner, 

11 while optimizing the probability of the long12 term sustainability of the CLASS program. 

13 ‘‘(3) DESIGNATION BY THE SECRETARY.—Not 

14 later than October 1, 2012, the Secretary, taking 

15 into consideration the recommendation of the 

16 CLASS Independence Advisory Council under para17 graph (2)(B), shall designate a benefit plan as the 

18 CLASS Independence Benefit Plan. The Secretary 

19 shall publish such designation, along with details of 

20 the plan and the reasons for the selection by the 

21 Secretary, in a final rule that allows for a period of 

22 public comment. 

23 ‘‘(b) ADDITIONAL PREMIUM REQUIREMENTS.— 

24 ‘‘(1) ADJUSTMENT OF PREMIUMS.— 


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1 ‘‘(A) IN GENERAL.—Except as provided in 

2 subparagraphs (B), (C), (D), and (E), the 

3 amount of the monthly premium determined for 

4 an individual upon such individual’s enrollment 

5 in the CLASS program shall remain the same 

6 for as long as the individual is an active en7 rollee in the program. 

8 ‘‘(B) RECALCULATED PREMIUM IF RE9 QUIRED FOR PROGRAM SOLVENCY.— 

10 ‘‘(i) IN GENERAL.—Subject to clause 

11 (ii), if the Secretary determines, based on 

12 the most recent report of the Board of 

13 Trustees of the CLASS Independence 

14 Fund, the advice of the CLASS Independ15 ence Advisory Council, and the annual re16 port of the Inspector General of the De17 partment of Health and Human Services, 

18 and waste, fraud, and abuse, or such other 

19 information as the Secretary determines 

20 appropriate, that the monthly premiums 

21 and income to the CLASS Independence 

22 Fund for a year are projected to be insuffi23 cient with respect to the 20-year period 

24 that begins with that year, the Secretary 

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1 dividuals enrolled in the CLASS program 

2 as necessary. 

3 ‘‘(ii) EXEMPTION FROM INCREASE.— 

4 Any increase in a monthly premium im5 posed as result of a determination de6 scribed in clause (i) shall not apply with 

7 respect to the monthly premium of any ac8 tive enrollee who— 

9 ‘‘(I) has attained age 65; 

10 ‘‘(II) has paid premiums for en11 rollment in the program for at least 

12 20 years; and 

13 ‘‘(III) is not actively employed. 

14 ‘‘(C) RECALCULATED PREMIUM IF RE15 ENROLLMENT AFTER MORE THAN A 3-MONTH

16 LAPSE.— 

17 ‘‘(i) IN GENERAL.—The reenrollment 

18 of an individual after a 90-day period dur19 ing which the individual failed to pay the 

20 monthly premium required to maintain the 

21 individual’s enrollment in the CLASS pro22 gram shall be treated as an initial enroll23 ment for purposes of age-adjusting the 

24 premium for enrollment in the program. 


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1 ‘‘(ii) CREDIT FOR PRIOR MONTHS IF

2 REENROLLED WITHIN 5 YEARS.—An indi3 vidual who reenrolls in the CLASS pro4 gram after such a 90-day period and be5 fore the end of the 5-year period that be6 gins with the first month for which the in7 dividual failed to pay the monthly premium 

8 required to maintain the individual’s en9 rollment in the program shall be— 

10 ‘‘(I) credited with any months of 

11 paid premiums that accrued prior to 

12 the individual’s lapse in enrollment; 

13 and 

14 ‘‘(II) notwithstanding the total 

15 amount of any such credited months, 

16 required to satisfy section 

17 3202(6)(A)(ii) before being eligible to 

18 receive benefits. 

19 ‘‘(D) PENALTY FOR REENOLLMENT AFTER

20 5-YEAR LAPSE.—In the case of an individual 

21 who reenrolls in the CLASS program after the 

22 end of the 5-year period described in subpara23 graph (C)(ii), the monthly premium required 

24 for the individual shall be the age-adjusted pre25 mium that would be applicable to an initially 


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1 enrolling individual who is the same age as the 

2 reenrolling individual, increased by the greater 

3 of— 

4 ‘‘(i) an amount that the Secretary de5 termines is actuarially sound for each 

6 month that occurs during the period that 

7 begins with the first month for which the 

8 individual failed to pay the monthly pre9 mium required to maintain the individual’s 

10 enrollment in the CLASS program and 

11 ends with the month preceding the month 

12 in which the reenollment is effective; or 

13 ‘‘(ii) 1 percent of the applicable age14 adjusted premium for each such month oc15 curring in such period. 

16 ‘‘(2) ADMINISTRATIVE EXPENSES.—In deter17 mining the monthly premiums for the CLASS pro18 gram the Secretary, in coordination with the Com19 missioner of Social Security, may factor in costs for 

20 administering the program, not to exceed— 

21 ‘‘(A) in the case of the first 5 years in 

22 which the program is in effect under this title, 

23 an amount equal to 3 percent of all premiums 

24 paid during each such year; and 


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1 ‘‘(B) in the case of subsequent years, an 

2 amount equal to 5 percent of the total amount 

3 of all expenditures (including benefits paid) 

4 under this title with respect to that year. 

5 ‘‘(3) NO UNDERWRITING REQUIREMENTS.—No 

6 underwriting (other than on the basis of age in ac7 cordance with paragraph (2)) shall be used to— 

8 ‘‘(A) determine the monthly premium for 

9 enrollment in the CLASS program; or 

10 ‘‘(B) prevent an individual from enrolling 

11 in the program. 

12 ‘‘SEC. 3204. ENROLLMENT AND DISENROLLMENT REQUIRE13 MENTS. 

14 ‘‘(a) AUTOMATIC ENROLLMENT.— 

15 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

16 the Secretary, in coordination with the Secretary of 

17 the Treasury, shall establish procedures under which 

18 each individual described in subsection (c) shall be 

19 automatically enrolled in the CLASS program by an 

20 employer of such individual in the same manner as 

21 an employer may elect to automatically enroll em22 ployees in a plan under section 401(k), 403(b), or 

23 457 of the Internal Revenue Code of 1986. 

24 ‘‘(2) ALTERNATIVE ENROLLMENT PROCE25 DURES.—The procedures established under paraVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00242 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 graph (1) shall provide for an alternative enrollment 

2 process for an individual described in subsection (c) 

3 in the case of such an individual— 

4 ‘‘(A) who is self-employed; 

5 ‘‘(B) who has more than 1 employer; 

6 ‘‘(C) whose employer does not elect to par7 ticipate in the automatic enrollment process es8 tablished by the Secretary; or 

9 ‘‘(D) who is a spouse described in sub10 section (c)(2) of who is not subject to automatic 

11 enrollment. 

12 ‘‘(3) ADMINISTRATION.— 

13 ‘‘(A) IN GENERAL.—The Secretary and the 

14 Secretary of the Treasury shall, by regulation, 

15 establish procedures to— 

16 ‘‘(i) ensure that an individual is not 

17 automatically enrolled in the CLASS pro18 gram by more than 1 employer; and 

19 ‘‘(ii) allow for an individual’s em20 ployer to deduct a premium for a spouse 

21 described in subsection (c)(1)(B) who is 

22 not subject to automatic enrollment. 

23 ‘‘(B) FORM.—Enrollment in the CLASS 

24 program shall be made in such manner as the 


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1 Secretary may prescribe in order to ensure ease 

2 of administration. 

3 ‘‘(b) ELECTION TO OPT-OUT.—An individual de4 scribed in subsection (c) may elect to waive enrollment in 

5 the CLASS program at any time in such form and manner 

6 as the Secretary and the Secretary of the Treasury shall 

7 prescribe. 

8 ‘‘(c) INDIVIDUAL DESCRIBED.—For purposes of en9 rolling in the CLASS program, an individual described in 

10 this paragraph is— 

11 ‘‘(1) an individual— 

12 ‘‘(A) who has attained age 18; 

13 ‘‘(B) who— 

14 ‘‘(i) receives wages on which there is 

15 imposed a tax under section 3201(a) of the 

16 Internal Revenue Code of 1986; or 

17 ‘‘(ii) derives self-employment income 

18 on which there is imposed a tax under sec19 tion 1401(a) of the Internal Revenue Code 

20 of 1986; 

21 ‘‘(C) who is actively employed; and 

22 ‘‘(D) who is not— 

23 ‘‘(i) a patient in a hospital or nursing 

24 facility, an intermediate care facility for 

25 the mentally retarded, or an institution for 


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1 mental diseases and receiving medical as2 sistance under Medicaid; or 

3 ‘‘(ii) confined in a jail, prison, other 

4 penal institution or correctional facility, or 

5 by court order pursuant to conviction of a 

6 criminal offense or in connection with a 

7 verdict or finding described in section 

8 202(x)(1)(A)(ii) of the Social Security Act 

9 (42 U.S.C. 402(x)(1)(A)(ii)); or 

10 ‘‘(2) the spouse of an individual described in 

11 paragraph (1) and who would be an individual so de12 scribed but for subparagraph (B) or (C) of that 

13 paragraph. 

14 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this title 

15 shall be construed as requiring an active enrollee to con16 tinue to satisfy subparagraph (B) or (C) of subsection 

17 (c)(1) in order to maintain enrollment in the CLASS pro18 gram. 

19 ‘‘(e) PAYMENT.— 

20 ‘‘(1) PAYROLL DEDUCTION.—An amount equal 

21 to the monthly premium for the enrollment in the 

22 CLASS program of an individual shall be deducted 

23 from the wages or self-employment income of such 

24 individual in accordance with such procedures as the 

25 Secretary, in coordination with the Secretary of the 


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1 Treasury, shall establish for employers who elect to 

2 deduct and withhold such premiums on behalf of en3 rolled employees. 

4 ‘‘(2) ALTERNATIVE PAYMENT MECHANISM.— 

5 The Secretary, in coordination with the Secretary of 

6 the Treasury, shall establish alternative procedures 

7 for the payment of monthly premiums by an indi8 vidual enrolled in the CLASS program— 

9 ‘‘(A) who does not have an employer who 

10 elects to deduct and withhold premiums in ac11 cordance with subparagraph (A); or 

12 ‘‘(B) who does not earn wages or derive 

13 self-employment income. 

14 ‘‘(f) TRANSFER OF PREMIUMS COLLECTED.— 

15 ‘‘(1) IN GENERAL.—During each calendar year 

16 the Secretary of the Treasury shall deposit into the 

17 CLASS Independence Fund a total amount equal, in 

18 the aggregate, to 100 percent of the premiums col19 lected during that year. 

20 ‘‘(2) TRANSFERS BASED ON ESTIMATES.—The 

21 amount deposited pursuant to paragraph (1) shall be 

22 transferred in at least monthly payments to the 

23 CLASS Independence Fund on the basis of esti24 mates by the Secretary and certified to the Sec25 retary of the Treasury of the amounts collected in 


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1 accordance with subparagraphs (A) and (B) of para2 graph (5). Proper adjustments shall be made in 

3 amounts subsequently transferred to the Fund to 

4 the extent prior estimates were in excess of, or were 

5 less than, actual amounts collected. 

6 ‘‘(g) OTHER ENROLLMENT AND DISENROLLMENT

7 OPPORTUNITIES.—The Secretary, in coordination with 

8 the Secretary of the Treasury, shall establish procedures 

9 under which— 

10 ‘‘(1) an individual who, in the year of the indi11 vidual’s initial eligibility to enroll in the CLASS pro12 gram, has elected to waive enrollment in the pro13 gram, is eligible to elect to enroll in the program, in 

14 such form and manner as the Secretaries shall es15 tablish, only during an open enrollment period estab16 lished by the Secretaries that is specific to the indi17 vidual and that may not occur more frequently than 

18 biennially after the date on which the individual first 

19 elected to waive enrollment in the program; and 

20 ‘‘(2) an individual shall only be permitted to 

21 disenroll from the program during an annual 

22 disenrollment period established by the Secretaries 

23 and in such form and manner as the Secretaries 

24 shall establish. 


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1 ‘‘SEC. 3205. BENEFITS. 

2 ‘‘(a) DETERMINATION OF ELIGIBILITY.— 

3 ‘‘(1) APPLICATION FOR RECEIPT OF BENE4 FITS.—The Secretary, in coordination with the Com5 missioner of Social Security, shall establish proce6 dures under which an active enrollee shall apply for 

7 receipt of benefits under the CLASS Independence 

8 Benefit Plan. 

9 ‘‘(2) ELIGIBILITY ASSESSMENTS.— 

10 ‘‘(A) IN GENERAL.—Not later than Janu11 ary 1, 2012, the Secretary shall enter into 

12 agreements with— 

13 ‘‘(i) the Disability Determination 

14 Service for each State to provide for eligi15 bility assessments of active enrollees who 

16 apply for receipt of benefits; 

17 ‘‘(ii) the Protection and Advocacy 

18 System for each State to provide advocacy 

19 services in accordance with subsection (d); 

20 and 

21 ‘‘(iii) public and private entities to 

22 provide advice and assistance counseling in 

23 accordance with subsection (e). 

24 ‘‘(B) REGULATIONS.—The Secretary, in 

25 coordination with the Commissioner of Social 

26 Security, shall promulgate regulations to deVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00248 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 velop an expedited eligibility determination 

2 process, as certified by a licensed health care 

3 practitioner, an appeals process, and a redeter4 mination process, as certified by a licensed 

5 health care practitioner, including whether an 

6 applicant is eligible for a cash benefit under the 

7 program and if so, the amount of the cash ben8 efit (in accordance the sliding scale established 

9 under the plan). 

10 ‘‘(C) PRESUMPTIVE ELIGIBILITY FOR CER11 TAIN INSTITUTIONALIZED ENROLLEES PLAN12 NING TO DISCHARGE.—An active enrollee shall 

13 be deemed presumptively eligible if the en14 rollee— 

15 ‘‘(i) has applied for, and attests is eli16 gible for, the maximum cash benefit avail17 able under the sliding scale established 

18 under the CLASS Independence Benefit 

19 Plan; 

20 ‘‘(ii) is a patient in a hospital (but 

21 only if the hospitalization is for long-term 

22 care), nursing facility, intermediate care 

23 facility for the mentally retarded, or an in24 stitution for mental diseases; and 


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1 ‘‘(iii) is in the process of, or about to 

2 being the process of, planning to discharge 

3 from the hospital, facility, or institution, or 

4 within 60 days from the date of discharge 

5 from the hospital, facility, or institution. 

6 ‘‘(D) APPEALS.—The Secretary shall es7 tablish procedures under which an applicant for 

8 benefits under the CLASS Independence Ben9 efit Plan shall be guaranteed the right to ap10 peal an adverse determination. 

11 ‘‘(b) BENEFITS.—An eligible beneficiary shall receive 

12 the following benefits under the CLASS Independence 

13 Benefit Plan: 

14 ‘‘(1) CASH BENEFIT.—A cash benefit estab15 lished by the Secretary in accordance with the re16 quirements of section 3203(a)(1)(D) that— 

17 ‘‘(A) the first year in which beneficiaries 

18 receive the benefits under the plan, is not less 

19 than the average dollar amount specified in 

20 clause (i) of such section; and 

21 ‘‘(B) for any subsequent year, is not less 

22 than the average per day dollar limit applicable 

23 under this subparagraph for the preceding year, 

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1 sumer price index for all urban consumers 

2 (U.S. city average) over the previous year. 

3 ‘‘(2) ADVOCACY SERVICES.—Advocacy services 

4 in accordance with subsection (d). 

5 ‘‘(3) ADVICE AND ASSISTANCE COUNSELING.— 

6 Advice and assistance counseling in accordance with 

7 subsection (e). 

8 ‘‘(4) ADMINISTRATIVE EXPENSES.—Advocacy 

9 services and advise and assistance counseling serv10 ices under paragraphs (2) and (3) of this subsection 

11 shall be included as administrative expenses under 

12 section 3203(b)(3). 

13 ‘‘(c) PAYMENT OF BENEFITS.— 

14 ‘‘(1) LIFE INDEPENDENCE ACCOUNT.— 

15 ‘‘(A) IN GENERAL.—The Secretary shall 

16 establish procedures for administering the pro17 vision of benefits to eligible beneficiaries under 

18 the CLASS Independence Benefit Plan, includ19 ing the payment of the cash benefit for the ben20 eficiary into a Life Independence Account es21 tablished by the Secretary on behalf of each eli22 gible beneficiary. 

23 ‘‘(B) USE OF CASH BENEFITS.—Cash ben24 efits paid into a Life Independence Account of 

25 an eligible beneficiary shall be used to purchase 


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1 nonmedical services and supports that the bene2 ficiary needs to maintain his or her independ3 ence at home or in another residential setting 

4 of their choice in the community, including (but 

5 not limited to) home modifications, assistive 

6 technology, accessible transportation, home7 maker services, respite care, personal assistance 

8 services, home care aides, and nursing support. 

9 Nothing in the preceding sentence shall prevent 

10 an eligible beneficiary from using cash benefits 

11 paid into a Life Independence Account for ob12 taining assistance with decision making con13 cerning medical care, including the right to ac14 cept or refuse medical or surgical treatment 

15 and the right to formulate advance directives or 

16 other written instructions recognized under 

17 State law, such as a living will or durable power 

18 of attorney for health care, in the case that an 

19 injury or illness causes the individual to be un20 able to make health care decisions. 

21 ‘‘(C) ELECTRONIC MANAGEMENT OF

22 FUNDS.—The Secretary shall establish proce23 dures for— 


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1 ‘‘(i) crediting an account established 

2 on behalf of a beneficiary with the bene3 ficiary’s cash daily benefit; 

4 ‘‘(ii) allowing the beneficiary to access 

5 such account through debit cards; and 

6 ‘‘(iii) accounting for withdrawals by 

7 the beneficiary from such account. 

8 ‘‘(D) PRIMARY PAYOR RULES FOR BENE9 FICIARIES WHO ARE ENROLLED IN MEDICAID.— 

10 In the case of an eligible beneficiary who is en11 rolled in Medicaid, the following payment rules 

12 shall apply: 

13 ‘‘(i) INSTITUTIONALIZED BENE14 FICIARY.—If the beneficiary is a patient in 

15 a hospital, nursing facility, intermediate 

16 care facility for the mentally retarded, or 

17 an institution for mental diseases, the ben18 eficiary shall retain an amount equal to 5 

19 percent of the beneficiary’s daily or weekly 

20 cash benefit (as applicable) (which shall be 

21 in addition to the amount of the bene22 ficiary’s personal needs allowance provided 

23 under Medicaid), and the remainder of 

24 such benefit shall be applied toward the fa25 cility’s cost of providing the beneficiary’s 


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1 care, and Medicaid shall provide secondary 

2 coverage for such care. 

3 ‘‘(ii) BENEFICIARIES RECEIVING

4 HOME AND COMMUNITY-BASED SERV5 ICES.— 

6 ‘‘(I) 50 PERCENT OF BENEFIT

7 RETAINED BY BENEFICIARY.—Subject 

8 to subclause (II), if a beneficiary is 

9 receiving medical assistance under 

10 Medicaid for home and community 

11 based services, the beneficiary shall 

12 retain an amount equal to 50 percent 

13 of the beneficiary’s daily or weekly 

14 cash benefit (as applicable), and the 

15 remainder of the daily or weekly cash 

16 benefit shall be applied toward the 

17 cost to the State of providing such as18 sistance (and shall not be used to 

19 claim Federal matching funds under 

20 Medicaid), and Medicaid shall provide 

21 secondary coverage for the remainder 

22 of any costs incurred in providing 

23 such assistance. 

24 ‘‘(II) REQUIREMENT FOR STATE

25 OFFSET.—A State shall be paid the 


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1 remainder of a beneficiary’s daily or 

2 weekly cash benefit under subclause 

3 (I) only if the State home and com4 munity-based waiver under section 

5 1115 of the Social Security Act (42 

6 U.S.C. 1315) or subsection (c) or (d) 

7 of section 1915 of such Act (42 

8 U.S.C. 1396n), or the State plan 

9 amendment under subsection (i) of 

10 such section does not include a waiver 

11 of the requirements of section 

12 1902(a)(1) of the Social Security Act 

13 (relating to statewideness) or of sec14 tion 1902(a)(10)(B) of such Act (re15 lating to comparability) and the State 

16 offers at a minimum case manage17 ment services, personal care services, 

18 habilitation services, and respite care 

19 under such a waiver or State plan 

20 amendment. 

21 ‘‘(III) DEFINITION OF HOME AND

22 COMMUNITY-BASED SERVICES.—In 

23 this clause, the term ‘home and com24 munity-based services’ means any 

25 services which may be offered under a 


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1 home and community-based waiver 

2 authorized for a State under section 

3 1115 of the Social Security Act (42 

4 U.S.C. 1315) or subsection (c) or (d) 

5 of section 1915 of such Act (42 

6 U.S.C. 1396n) or under a State plan 

7 amendment under subsection (i) of 

8 such section. 

9 ‘‘(iii) BENEFICIARIES ENROLLED IN

10 PROGRAMS OF ALL-INCLUSIVE CARE FOR

11 THE ELDERLY (PACE).— 

12 ‘‘(I) IN GENERAL.—Subject to 

13 subclause (II), if a beneficiary is re14 ceiving medical assistance under Med15 icaid for PACE program services 

16 under section 1934 of the Social Secu17 rity Act (42 U.S.C. 1396u–4), the 

18 beneficiary shall retain an amount 

19 equal to 50 percent of the bene20 ficiary’s daily or weekly cash benefit 

21 (as applicable), and the remainder of 

22 the daily or weekly cash benefit shall 

23 be applied toward the cost to the 

24 State of providing such assistance 

25 (and shall not be used to claim FedVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00256 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 eral matching funds under Medicaid), 

2 and Medicaid shall provide secondary 

3 coverage for the remainder of any 

4 costs incurred in providing such as5 sistance. 

6 ‘‘(II) INSTITUTIONALIZED RE7 CIPIENTS OF PACE PROGRAM SERV8 ICES.—If a beneficiary receiving as9 sistance under Medicaid for PACE 

10 program services is a patient in a hos11 pital, nursing facility, intermediate 

12 care facility for the mentally retarded, 

13 or an institution for mental diseases, 

14 the beneficiary shall be treated as in 

15 institutionalized beneficiary under 

16 clause (i). 

17 ‘‘(2) AUTHORIZED REPRESENTATIVES.— 

18 ‘‘(A) IN GENERAL.—The Secretary shall 

19 establish procedures to allow access to a bene20 ficiary’s cash benefits by an authorized rep21 resentative of the eligible beneficiary on whose 

22 behalf such benefits are paid. 

23 ‘‘(B) QUALITY ASSURANCE AND PROTEC24 TION AGAINST FRAUD AND ABUSE.—The proce25 dures established under subparagraph (A) shall 


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1 ensure that authorized representatives of eligi2 ble beneficiaries comply with standards of con3 duct established by the Secretary, including 

4 standards requiring that such representatives 

5 provide quality services on behalf of such bene6 ficiaries, do not have conflicts of interest, and 

7 do not misuse benefits paid on behalf of such 

8 beneficiaries or otherwise engage in fraud or 

9 abuse. 

10 ‘‘(3) COMMENCEMENT OF BENEFITS.—Benefits 

11 shall be paid to, or on behalf of, an eligible bene12 ficiary beginning with the first month in which an 

13 application for such benefits is approved. 

14 ‘‘(4) ROLLOVER OPTION FOR LUMP-SUM PAY15 MENT.—An eligible beneficiary may elect to— 

16 ‘‘(A) defer payment of their daily or weekly 

17 benefit and to rollover any such deferred bene18 fits from month-to-month, but not from year-to19 year; and 

20 ‘‘(B) receive a lump-sum payment of such 

21 deferred benefits in an amount that may not 

22 exceed the lesser of— 

23 ‘‘(i) the total amount of the accrued 

24 deferred benefits; or 

25 ‘‘(ii) the applicable annual benefit. 


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1 ‘‘(5) PERIOD FOR DETERMINATION OF ANNUAL

2 BENEFITS.— 

3 ‘‘(A) IN GENERAL.—The applicable period 

4 for determining with respect to an eligible bene5 ficiary the applicable annual benefit and the 

6 amount of any accrued deferred benefits is the 

7 12-month period that commences with the first 

8 month in which the beneficiary began to receive 

9 such benefits, and each 12-month period there10 after. 

11 ‘‘(B) INCLUSION OF INCREASED BENE12 FITS.—The Secretary shall establish procedures 

13 under which cash benefits paid to an eligible 

14 beneficiary that increase or decrease as a result 

15 of a change in the functional status of the bene16 ficiary before the end of a 12-month benefit pe17 riod shall be included in the determination of 

18 the applicable annual benefit paid to the eligible 

19 beneficiary. 

20 ‘‘(C) RECOUPMENT OF UNPAID, ACCRUED

21 BENEFITS.— 

22 ‘‘(i) IN GENERAL.—The Secretary, in 

23 coordination with the Secretary of the 

24 Treasury, shall recoup any accrued bene25 fits in the event of— 


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1 ‘‘(I) the death of a beneficiary; or 

2 ‘‘(II) the failure of a beneficiary 

3 to elect under paragraph (4)(B) to re4 ceive such benefits as a lump-sum 

5 payment before the end of the 12- 

6 month period in which such benefits 

7 accrued. 

8 ‘‘(ii) PAYMENT INTO CLASS INDE9 PENDENCE FUND.—Any benefits recouped 

10 in accordance with clause (i) shall be paid 

11 into the CLASS Independence Fund and 

12 used in accordance with section 3206. 

13 ‘‘(6) REQUIREMENT TO RECERTIFY ELIGIBILITY

14 FOR RECEIPT OF BENEFITS.—An eligible beneficiary 

15 shall periodically, as determined by the Secretary, in 

16 coordination with the Commissioner of Social Secu17 rity— 

18 ‘‘(A) recertify by submission of medical 

19 evidence the beneficiary’s continued eligibility 

20 for receipt of benefits; and 

21 ‘‘(B) submit records of expenditures attrib22 utable to the aggregate cash benefit received by 

23 the beneficiary during the preceding year. 

24 ‘‘(7) SUPPLEMENT, NOT SUPPLANT OTHER

25 HEALTH CARE BENEFITS.—Subject to the Medicaid 


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1 payment rules under paragraph (1)(D), benefits re2 ceived by an eligible beneficiary shall supplement, 

3 but not supplant, other health care benefits for 

4 which the beneficiary is eligible under Medicaid or 

5 any other Federally funded program that provides 

6 health care benefits or assistance. 

7 ‘‘(d) ADVOCACY SERVICES.—An agreement entered 

8 into under subsection (a)(2)(A)(ii) shall require the Pro9 tection and Advocacy System for the State to— 

10 ‘‘(1) assign, as needed, an advocacy counselor 

11 to each eligible beneficiary that is covered by such 

12 agreement and who shall provide an eligible bene13 ficiary with— 

14 ‘‘(A) information regarding how to access 

15 the appeals process established for the program; 

16 ‘‘(B) assistance with respect to the annual 

17 recertification and notification required under 

18 subsection (c)(6); and 

19 ‘‘(C) such other assistance with obtaining 

20 services as the Secretary, by regulation, shall 

21 require; and 

22 ‘‘(2) ensure that the System and such coun23 selors comply with the requirements of subsection 

24 (h). 


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1 ‘‘(e) ADVICE AND ASSISTANCE COUNSELING.—An 

2 agreement entered into under subsection (a)(2)(A)(iii) 

3 shall require the entity to assign, as requested by an eligi4 ble beneficiary that is covered by such agreement, an ad5 vice and assistance counselor who shall provide an eligible 

6 beneficiary with information regarding— 

7 ‘‘(1) accessing and coordinating long-term serv8 ices and supports in the most integrated setting; 

9 ‘‘(2) possible eligibility for other benefits and 

10 services; 

11 ‘‘(3) development of a service and support plan; 

12 ‘‘(4) information about programs established 

13 under the Assistive Technology Act of 1998 and the 

14 services offered under such programs; 

15 ‘‘(5) available assistance with decision making 

16 concerning medical care, including the right to ac17 cept or refuse medical or surgical treatment and the 

18 right to formulate advance directives or other writ19 ten instructions recognized under State law, such as 

20 a living will or durable power of attorney for health 

21 care, in the case that an injury or illness causes the 

22 individual to be unable to make health care deci23 sions; and 

24 ‘‘(6) such other services as the Secretary, by 

25 regulation, may require. 


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1 ‘‘(f) NO EFFECT ON ELIGIBILITY FOR OTHER BENE2 FITS.—Benefits paid to an eligible beneficiary under the 

3 CLASS program shall be disregarded for purposes of de4 termining or continuing the beneficiary’s eligibility for re5 ceipt of benefits under any other Federal, State, or locally 

6 funded assistance program, including benefits paid under 

7 titles II, XVI, XVIII, XIX, or XXI of the Social Security 

8 Act (42 U.S.C. 401 et seq., 1381 et seq., 1395 et seq., 

9 1396 et seq., 1397aa et seq.), under the laws administered 

10 by the Secretary of Veterans Affairs, under low-income 

11 housing assistance programs, or under the supplemental 

12 nutrition assistance program established under the Food 

13 and Nutrition Act of 2008 (7 U.S.C. 2011 et seq.). 

14 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this title 

15 shall be construed as prohibiting benefits paid under the 

16 CLASS Independence Benefit Plan from being used to 

17 compensate a family caregiver for providing community 

18 living assistance services and supports to an eligible bene19 ficiary. 

20 ‘‘(h) PROTECTION AGAINST CONFLICT OF INTER21 ESTS.—The Secretary shall establish procedures to ensure 

22 that the Disability Determination Service and Protection 

23 and Advocacy System for a State, advocacy counselors for 

24 eligible beneficiaries, and any other entities that provide 


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1 services to active enrollees and eligible beneficiaries under 

2 the CLASS program comply with the following: 

3 ‘‘(1) If the entity provides counseling or plan4 ning services, such services are provided in a manner 

5 that fosters the best interests of the active enrollee 

6 or beneficiary. 

7 ‘‘(2) The entity has established operating proce8 dures that are designed to avoid or minimize con9 flicts of interest between the entity and an active en10 rollee or beneficiary. 

11 ‘‘(3) The entity provides information about all 

12 services and options available to the active enrollee 

13 or beneficiary, to the best of its knowledge, including 

14 services available through other entities or providers. 

15 ‘‘(4) The entity assists the active enrollee or 

16 beneficiary to access desired services, regardless of 

17 the provider. 

18 ‘‘(5) The entity reports the number of active 

19 enrollees and beneficiaries provided with assistance 

20 by age, disability, and whether such enrollees and 

21 beneficiaries received services from the entity or an22 other entity. 

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1 rollee or beneficiary is informed of any financial in2 terest that the entity has in a service provider. 

3 ‘‘(7) The entity provides an active enrollee or 

4 beneficiary with a list of available service providers 

5 that can meet the needs of the active enrollee or 

6 beneficiary. 

7 The Secretary shall establish the procedures under this 

8 subsection that apply to the Disability Determination 

9 Service in coordination with the Commissioner of Social 

10 Security. 

11 ‘‘SEC. 3206. CLASS INDEPENDENCE FUND. 

12 ‘‘(a) ESTABLISHMENT OF CLASS INDEPENDENCE

13 FUND.—There is established in the Treasury of the 

14 United States a trust fund to be known as the ‘CLASS 

15 Independence Fund’. The Secretary of the Treasury shall 

16 serve as Managing Trustee of such Fund. The Fund shall 

17 consist of all amounts derived from payments into the 

18 Fund under sections 3204(f) and 3205(c)(5)(C)(ii), and 

19 remaining after investment of such amounts under sub20 section (b), including additional amounts derived as in21 come from such investments. The amounts held in the 

22 Fund are appropriated and shall remain available without 

23 fiscal year limitation— 

24 ‘‘(1) to be held for investment on behalf of indi25 viduals enrolled in the CLASS program; 


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1 ‘‘(2) to pay the administrative expenses related 

2 to the Fund and to investment under subsection (b); 

3 and 

4 ‘‘(3) to pay cash benefits to eligible bene5 ficiaries under the CLASS Independence Benefit 

6 Plan. 

7 ‘‘(b) INVESTMENT OF FUND BALANCE.—The Sec8 retary of the Treasury shall invest and manage the 

9 CLASS Independence Fund in the same manner, and to 

10 the same extent, as the Federal Supplementary Medical 

11 Insurance Trust Fund may be invested and managed 

12 under subsections (c), (d), and (e) of section 1841(d) of 

13 the Social Security Act (42 U.S.C. 1395t). 

14 ‘‘(c) LOCK-BOX PROTECTION.— 

15 ‘‘(1) IN GENERAL.—Notwithstanding any other 

16 provision of law, it shall not be in order in the Sen17 ate or the House of Representatives to consider any 

18 measure that would authorize the payment or use of 

19 amounts in the Fund for any purpose other than a 

20 purpose authorized under this title. 

21 ‘‘(2) 60-VOTE WAIVER REQUIRED IN THE SEN22 ATE.— 

23 ‘‘(A) IN GENERAL.—Paragraph (1) may be 

24 waived or suspended in the Senate only by the 


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affirmative vote of 3 1 ⁄5 of the Members, duly 

2 chosen and sworn. 

3 ‘‘(B) APPEALS.— 

4 ‘‘(i) PROCEDURE.—Appeals in the 

5 Senate from the decisions of the Chair re6 lating to subparagraph (A) shall be limited 

7 to 1 hour, to be equally divided between, 

8 and controlled by, the mover and the man9 ager of the measure that would authorize 

10 the payment or use of amounts in the 

11 Fund for a purpose other than a purpose 

12 authorized under this title. 

13 ‘‘(ii) 60-VOTES REQUIRED.—An affirmative vote of 3 14 ⁄5 of the Members, duly 

15 chosen and sworn, shall be required in the 

16 Senate to sustain an appeal of the ruling 

17 of the Chair on a point of order raised in 

18 relation to subparagraph (A). 

19 ‘‘(3) RULES OF THE SENATE AND HOUSE OF

20 REPRESENTATIVES.—This subsection is enacted by 

21 Congress— 

22 ‘‘(A) as an exercise of the rulemaking 

23 power of the Senate and House of Representa24 tives, respectively, and is deemed to be part of 

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1 cable only with respect to the procedure to be 

2 followed in that House in the case of a measure 

3 described in paragraph (1), and it supersedes 

4 other rules only to the extent that it is incon5 sistent with such rules; and 

6 ‘‘(B) with full recognition of the constitu7 tional right of either House to change the rules 

8 (so far as they relate to the procedure of that 

9 House) at any time, in the same manner, and 

10 to the same extent as in the case of any other 

11 rule of that House. 

12 ‘‘(d) BOARD OF TRUSTEES.— 

13 ‘‘(1) IN GENERAL.—With respect to the CLASS 

14 Independence Fund, there is hereby created a body 

15 to be known as the Board of Trustees of the CLASS 

16 Independence Fund (hereinafter in this section re17 ferred to as the ‘Board of Trustees’) composed of 

18 the Commissioner of Social Security, the Secretary 

19 of the Treasury, the Secretary of Labor, and the 

20 Secretary of Health and Human Services, all ex offi21 cio, and of two members of the public (both of whom 

22 may not be from the same political party), who shall 

23 be nominated by the President for a term of 4 years 

24 and subject to confirmation by the Senate. A mem25 ber of the Board of Trustees serving as a member 


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1 of the public and nominated and confirmed to fill a 

2 vacancy occurring during a term shall be nominated 

3 and confirmed only for the remainder of such term. 

4 An individual nominated and confirmed as a member 

5 of the public may serve in such position after the ex6 piration of such member’s term until the earlier of 

7 the time at which the member’s successor takes of8 fice or the time at which a report of the Board is 

9 first issued under paragraph (2) after the expiration 

10 of the member’s term. The Secretary of the Treas11 ury shall be the Managing Trustee of the Board of 

12 Trustees. The Board of Trustees shall meet not less 

13 frequently than once each calendar year. A person 

14 serving on the Board of Trustees shall not be con15 sidered to be a fiduciary and shall not be personally 

16 liable for actions taken in such capacity with respect 

17 to the Trust Fund. 

18 ‘‘(2) DUTIES.— 

19 ‘‘(A) IN GENERAL.—It shall be the duty of 

20 the Board of Trustees to do the following: 

21 ‘‘(i) Hold the CLASS Independence 

22 Fund. 

23 ‘‘(ii) Report to the Congress not later 

24 than the first day of April of each year on 

25 the operation and status of the CLASS 


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1 Independence Fund during the preceding 

2 fiscal year and on its expected operation 

3 and status during the current fiscal year 

4 and the next 2 fiscal years. 

5 ‘‘(iii) Report immediately to the Con6 gress whenever the Board is of the opinion 

7 that the amount of the CLASS Independ8 ence Fund is not actuarially sound in re9 gards to the projections under section 

10 3203(b)(2)(B)(i). 

11 ‘‘(iv) Review the general policies fol12 lowed in managing the CLASS Independ13 ence Fund, and recommend changes in 

14 such policies, including necessary changes 

15 in the provisions of law which govern the 

16 way in which the CLASS Independence 

17 Fund is to be managed. 

18 ‘‘(B) REPORT.—The report provided for in 

19 subparagraph (A)(ii) shall— 

20 ‘‘(i) include— 

21 ‘‘(I) a statement of the assets of, 

22 and the disbursements made from, the 

23 CLASS Independence Fund during 

24 the preceding fiscal year; 


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1 ‘‘(II) an estimate of the expected 

2 income to, and disbursements to be 

3 made from, the CLASS Independence 

4 Fund during the current fiscal year 

5 and each of the next 2 fiscal years; 

6 ‘‘(III) a statement of the actu7 arial status of the CLASS Independ8 ence Fund for the current fiscal year, 

9 each of the next 2 fiscal years, and as 

10 projected over the 75-year period be11 ginning with the current fiscal year; 

12 ‘‘(IV) an actuarial opinion by the 

13 Chief Actuary of the Social Security 

14 Administration certifying that the 

15 techniques and methodologies used 

16 are generally accepted within the ac17 tuarial profession and that the as18 sumptions and cost estimates used are 

19 reasonable; and 

20 ‘‘(V) an opinion by the Commis21 sioner of Social Security that the Dis22 ability Determination Service per23 sonnel are not over burdened by the 

24 additional requirements of the CLASS 

25 program; and 


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1 ‘‘(ii) be printed as a House document 

2 of the session of the Congress to which the 

3 report is made. 

4 ‘‘(C) RECOMMENDATIONS.—If the Board 

5 of Trustees determines that enrollment trends 

6 and expected future benefit claims on the 

7 CLASS Independence Fund are not actuarially 

8 sound in regards to the projections under sec9 tion 3203(b)(2)(B)(i) and are unlikely to be re10 solved with reasonable premium increases or 

11 through other means, the Board of Trustees 

12 shall include in the report provided for in sub13 paragraph (A)(ii) recommendations for such 

14 legislative action as the Board of Trustees de15 termine to be appropriate, including whether to 

16 adjust monthly premiums or impose a tem17 porary moratorium on new enrollments. 

18 ‘‘SEC. 3207. CLASS INDEPENDENCE ADVISORY COUNCIL. 

19 ‘‘(a) ESTABLISHMENT.—There is hereby created an 

20 Advisory Committee to be known as the ‘CLASS Inde21 pendence Advisory Council’. 

22 ‘‘(b) MEMBERSHIP.— 

23 ‘‘(1) IN GENERAL.—The CLASS Independence 

24 Advisory Council shall be composed of not more 


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1 than 15 individuals, not otherwise in the employ of 

2 the United States— 

3 ‘‘(A) who shall be appointed by the Presi4 dent without regard to the civil service laws and 

5 regulations; and 

6 ‘‘(B) a majority of whom shall be rep7 resentatives of individuals who participate or 

8 are likely to participate in the CLASS program, 

9 and shall include representatives of older and 

10 younger workers, individuals with disabilities, 

11 family caregivers of individuals who require 

12 services and supports to maintain their inde13 pendence at home or in another residential set14 ting of their choice in the community, individ15 uals with expertise in long-term care or dis16 ability insurance, actuarial science, economics, 

17 and other relevant disciplines, as determined by 

18 the Secretary. 

19 ‘‘(2) TERMS.— 

20 ‘‘(A) IN GENERAL.—The members of the 

21 CLASS Independence Advisory Council shall 

22 serve overlapping terms of 3 years (unless ap23 pointed to fill a vacancy occurring prior to the 

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1 vidual shall serve for the remainder of the 

2 term). 

3 ‘‘(B) LIMITATION.—A member shall not be 

4 eligible to serve for more than 2 consecutive 

5 terms. 

6 ‘‘(3) CHAIR.—The President shall, from time to 

7 time, appoint one of the members of the CLASS 

8 Independence Advisory Council to serve as the 

9 Chair. 

10 ‘‘(c) DUTIES.—The CLASS Independence Advisory 

11 Council shall advise the Secretary on matters of general 

12 policy in the administration of the CLASS program estab13 lished under this title and in the formulation of regula14 tions under this title including with respect to— 

15 ‘‘(1) the development of the CLASS Independ16 ence Benefit Plan under section 3203; and 

17 ‘‘(2) the determination of monthly premiums 

18 under such plan. 

19 ‘‘(d) APPLICATION OF FACA.—The Federal Advisory 

20 Committee Act (5 U.S.C. App.), other than section 14 of 

21 that Act, shall apply to the CLASS Independence Advisory 

22 Council. 

23 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

24 ‘‘(1) IN GENERAL.—There are authorized to be 

25 appropriated to the CLASS Independence Advisory 


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1 Council to carry out its duties under this section, 

2 such sums as may be necessary for fiscal year 2011 

3 and for each fiscal year thereafter. 

4 ‘‘(2) AVAILABILITY.—Any sums appropriated 

5 under the authorization contained in this section 

6 shall remain available, without fiscal year limitation, 

7 until expended. 

8 ‘‘SEC. 3208. REGULATIONS; ANNUAL REPORT. 

9 ‘‘(a) REGULATIONS.—The Secretary shall promulgate 

10 such regulations as are necessary to carry out the CLASS 

11 program in accordance with this title. Such regulations 

12 shall include provisions to prevent fraud and abuse under 

13 the program. 

14 ‘‘(b) ANNUAL REPORT.—Beginning January 1, 2014, 

15 the Secretary shall submit an annual report to Congress 

16 on the CLASS program. Each report shall include the fol17 lowing: 

18 ‘‘(1) The total number of enrollees in the pro19 gram. 

20 ‘‘(2) The total number of eligible beneficiaries 

21 during the fiscal year. 

22 ‘‘(3) The total amount of cash benefits provided 

23 during the fiscal year. 

24 ‘‘(4) A description of instances of fraud or 

25 abuse identified during the fiscal year. 


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1 ‘‘(5) Recommendations for such administrative 

2 or legislative action as the Secretary determines is 

3 necessary to improve the program or to prevent the 

4 occurrence of fraud or abuse. 

5 ‘‘SEC. 3209. INSPECTOR GENERAL’S REPORT. 

6 ‘‘The Inspector General of the Department of Health 

7 and Human Services shall submit an annual report to the 

8 Secretary and Congress relating to the overall progress of 

9 the CLASS program and of the existence of waste, fraud, 

10 and abuse in the CLASS program. Each such report shall 

11 include findings in the following areas: 

12 ‘‘(1) The eligibility determination process. 

13 ‘‘(2) The provision of cash benefits. 

14 ‘‘(3) Quality assurance and protection against 

15 waste, fraud, and abuse. 

16 ‘‘(4) Recouping of unpaid and accrued benefits. 

17 ‘‘SEC. 3210. TAX TREATMENT OF PROGRAM. 

18 ‘‘The CLASS program shall be treated for purposes 

19 of the Internal Revenue Code of 1986 in the same manner 

20 as a qualified long-term care insurance contract for quali21 fied long-term care services.’’. 

22 (2) CONFORMING AMENDMENTS TO MED23 ICAID.—Section 1902(a) of the Social Security Act 

24 (42 U.S.C. 1396a(a)), as amended by section 


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1 5006(e)(2)(A) of division B of Public Law 111–5, is 

2 amended— 

3 (A) in paragraph (72), by striking ‘‘and’’ 

4 at the end; 

5 (B) in paragraph (73)(B), by striking the 

6 period and inserting ‘‘; and’’; and 

7 (C) by inserting after paragraph (73) the 

8 following: 

9 ‘‘(74) provide that the State will comply with 

10 such regulations regarding the application of pri11 mary and secondary payor rules with respect to indi12 viduals who are eligible for medical assistance under 

13 this title and are eligible beneficiaries under the 

14 CLASS program established under title XXXII of 

15 the Public Health Service Act as the Secretary shall 

16 establish.’’. 

17 (b) ASSURANCE OF ADEQUATE INFRASTRUCTURE

18 FOR THE PROVISION OF PERSONAL CARE ATTENDANT

19 WORKERS.—Section 1902(a) of the Social Security Act 

20 (42 U.S.C. 1396a(a)), as amended by subsection (a)(2), 

21 is amended— 

22 (1) in paragraph (73)(B), by striking ‘‘and’’ at 

23 the end; 

24 (2) in paragraph (74), by striking the period at 

25 the end and inserting ‘‘; and’’; and 


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1 (3) by inserting after paragraph (74), the fol2 lowing: 

3 ‘‘(75) provide that, not later than 2 years after 

4 the date of enactment of the Community Living As5 sistance Services and Supports Act, each State 

6 shall— 

7 ‘‘(A) assess the extent to which entities 

8 such as providers of home care, home health 

9 services, home and community service providers, 

10 public authorities created to provide personal 

11 care services to individuals eligible for medical 

12 assistance under the State plan, and nonprofit 

13 organizations, are serving or have the capacity 

14 to serve as fiscal agents for, employers of, and 

15 providers of employment-related benefits for, 

16 personal care attendant workers who provide 

17 personal care services to individuals receiving 

18 benefits under the CLASS program established 

19 under title XXXII of the Public Health Service 

20 Act, including in rural and underserved areas; 

21 ‘‘(B) designate or create such entities to 

22 serve as fiscal agents for, employers of, and 

23 providers of employment-related benefits for, 

24 such workers to ensure an adequate supply of 

25 the workers for individuals receiving benefits 


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1 under the CLASS program, including in rural 

2 and underserved areas; and 

3 ‘‘(C) ensure that the designation or cre4 ation of such entities will not negatively alter or 

5 impede existing programs, models, methods, or 

6 administration of service delivery that provide 

7 for consumer controlled or self-directed home 

8 and community services and further ensure that 

9 such entities will not impede the ability of indi10 viduals to direct and control their home and 

11 community services, including the ability to se12 lect, manage, dismiss, co-employ, or employ 

13 such workers or inhibit such individuals from 

14 relying on family members for the provision of 

15 personal care services.’’. 

16 (c) PERSONAL CARE ATTENDANTS WORKFORCE AD17 VISORY PANEL.— 

18 (1) ESTABLISHMENT.—Not later than 90 days 

19 after the date of enactment of this Act, the Sec20 retary of Health and Human Services shall establish 

21 a Personal Care Attendants Workforce Advisory 

22 Panel for the purpose of examining and advising the 

23 Secretary and Congress on workforce issues related 

24 to personal care attendant workers, including with 

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1 ers, the salaries, wages, and benefits of such work2 ers, and access to the services provided by such 

3 workers. 

4 (2) MEMBERSHIP.—In appointing members to 

5 the Personal Care Attendants Workforce Advisory 

6 Panel, the Secretary shall ensure that such members 

7 include the following: 

8 (A) Individuals with disabilities of all ages. 

9 (B) Senior individuals. 

10 (C) Representatives of individuals with dis11 abilities. 

12 (D) Representatives of senior individuals. 

13 (E) Representatives of workforce and labor 

14 organizations. 

15 (F) Representatives of home and commu16 nity-based service providers. 

17 (G) Representatives of assisted living pro18 viders. 

19 (d) INCLUSION OF INFORMATION ON SUPPLEMENTAL

20 COVERAGE IN THE NATIONAL CLEARINGHOUSE FOR

21 LONG-TERM CARE INFORMATION; EXTENSION OF FUND22 ING.—Section 6021(d) of the Deficit Reduction Act of 

23 2005 (42 U.S.C. 1396p note) is amended— 

24 (1) in paragraph (2)(A)— 


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1 (A) in clause (ii), by striking ‘‘and’’ at the 

2 end; 

3 (B) in clause (iii), by striking the period at 

4 the end and inserting ‘‘; and’’; and 

5 (C) by adding at the end the following: 

6 ‘‘(iv) include information regarding 

7 the CLASS program established under 

8 title XXXII of the Public Health Service 

9 Act and coverage available for purchase 

10 through a Gateway established under sec11 tion 3101 of such Act that is supplemental 

12 coverage to the benefits provided under a 

13 CLASS Independence Benefit Plan under 

14 that program.’’; and 

15 (2) in paragraph (3), by striking ‘‘2010’’ and 

16 inserting ‘‘2015’’. 

17 (e) EFFECTIVE DATE.—The amendments made by 

18 subsections (a), (b), and (d) take effect on January 1, 

19 2011. 


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1 TITLE II—IMPROVING THE 

2 QUALITY AND EFFICIENCY OF 

3 HEALTH CARE 

4 Subtitle A—National Strategy to 

5 Improve Health Care Quality 

6 SEC. 201. NATIONAL STRATEGY. 

7 (a) IN GENERAL.—Title III of the Public Health 

8 Service Act (42 U.S.C. 241 et seq.) is amended by adding 

9 at the end the following: 

10 ‘‘PART S—HEALTH CARE QUALITY PROGRAMS 

11 ‘‘Subpart I—National Strategy for Quality 

12 Improvement in Health Care 

13 ‘‘SEC. 399HH. NATIONAL STRATEGY FOR QUALITY IM14 PROVEMENT IN HEALTH CARE. 

15 ‘‘(a) ESTABLISHMENT OF NATIONAL STRATEGY AND

16 PRIORITIES.— 

17 ‘‘(1) NATIONAL STRATEGY.—The Secretary, 

18 through a transparent collaborative process, shall es19 tablish a national strategy to improve the delivery of 

20 health care services, patient health outcomes, and 

21 population health. 

22 ‘‘(2) IDENTIFICATION OF PRIORITIES.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall 

24 identify national priorities for improvement in 

25 developing the strategy under paragraph (1). 


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1 ‘‘(B) REQUIREMENTS.—The Secretary 

2 shall ensure that priorities identified under sub3 paragraph (A) will— 

4 ‘‘(i) address the health care provided 

5 to patients with high-cost chronic diseases; 

6 ‘‘(ii) improve the design, development, 

7 demonstration, dissemination, and adop8 tion of infrastructure and innovative meth9 odologies and strategies for quality im10 provement in the delivery of health care 

11 services that represent best practices to 

12 improve patient safety and reduce medical 

13 errors, preventable admissions and re14 admissions, and health care-associated in15 fections; 

16 ‘‘(iii) have the greatest potential for 

17 improving the health outcomes, efficiency, 

18 and patient-centeredness of health care; 

19 ‘‘(iv) reduce health disparities across 

20 health disparity populations (as defined by 

21 section 485E) and geographic areas; 

22 ‘‘(v) address gaps in quality and 

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1 tion techniques, including the use of data 

2 registries; 

3 ‘‘(vi) identify areas in the delivery of 

4 health care services that have the potential 

5 for rapid improvement in the quality of pa6 tient care; 

7 ‘‘(vii) improve Federal payment policy 

8 to emphasize quality; 

9 ‘‘(viii) enhance the use of health care 

10 data to improve quality, transparency, and 

11 outcomes; and 

12 ‘‘(ix) address other areas as deter13 mined appropriate by the Secretary. 

14 ‘‘(C) CONSIDERATIONS.—In identifying 

15 priorities under subparagraph (A), the Sec16 retary shall take into consideration— 

17 ‘‘(i) the recommendations submitted 

18 by qualified consensus-based entities as re19 quired under section 399JJ; and 

20 ‘‘(ii) the recommendations of the 

21 Interagency Working Group on Health 

22 Care Quality established under section 202 

23 of the Affordable Health Choices Act. 

24 ‘‘(b) STRATEGIC PLAN.— 


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1 ‘‘(1) IN GENERAL.—The national strategy shall 

2 include a comprehensive strategic plan to achieve the 

3 priorities described in subsection (a). 

4 ‘‘(2) REQUIREMENTS.—The strategic plan shall 

5 include provisions for addressing, at a minimum, the 

6 following: 

7 ‘‘(A) Coordination among agencies within 

8 the Department, which shall include steps to 

9 minimize duplication of efforts and utilization 

10 of common quality measures, where available. 

11 Such common quality measures shall be meas12 ures endorsed under section 399JJ. 

13 ‘‘(B) Agency-specific strategic plans to 

14 achieve national priorities. 

15 ‘‘(C) Establishment of annual benchmarks 

16 for each relevant agency to achieve national pri17 orities. 

18 ‘‘(D) A process for regular reporting by 

19 the agencies to the Secretary on the implemen20 tation of the strategic plan. 

21 ‘‘(E) Use of common incentives among 

22 public and private payers with regard to quality 

23 and patient safety efforts. 

24 ‘‘(F) Incorporating quality improvement 

25 and measurement in the strategic plan for 


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1 health information technology required by the 

2 American Recovery and Reinvestment Act of 

3 2009 (Public Law 111–5). 

4 ‘‘(c) PERIODIC UPDATE OF NATIONAL STRATEGY.— 

5 The Secretary shall update the national strategy not less 

6 than triennially. Any such update shall include a review 

7 of short- and long-term goals. 

8 ‘‘(d) SUBMISSION AND AVAILABILITY OF NATIONAL

9 STRATEGY.—The Secretary shall transmit to the relevant 

10 Committees of Congress the national strategy and updates 

11 to such strategy. 

12 ‘‘(e) PUBLIC REPORTING.— 

13 ‘‘(1) ANNUAL NATIONAL HEALTH CARE QUAL14 ITY REPORT CARD.—Not later than January 31, 

15 2011, and annually thereafter, the Secretary shall 

16 publish a national health care quality report card, 

17 which shall include— 

18 ‘‘(A) the considerations for national prior19 ities described in subsection (a)(2); 

20 ‘‘(B) an analysis of the progress of the 

21 strategic plans under subsection (b)(2)(B) in 

22 achieving the national priorities under sub23 section (a)(2), and any gaps in such strategic 

24 plans; 


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1 ‘‘(C) the extent to which private sector 

2 strategies have informed Federal quality im3 provement efforts; and 

4 ‘‘(D) a summary of consumer and provider 

5 feedback regarding quality improvement prac6 tices. 

7 ‘‘(2) WEBSITE.—Not later than July 1, 2010, 

8 the Director shall create an Internet website to 

9 make public information regarding— 

10 ‘‘(A) the national priorities for health care 

11 quality improvement established under sub12 section (a)(2); 

13 ‘‘(B) the agency-specific strategic plans for 

14 health care quality described in subsection 

15 (b)(2)(B); 

16 ‘‘(C) the annual national health care qual17 ity report card described in paragraph (1); and 

18 ‘‘(D) other information, as the Secretary 

19 determines to be appropriate.’’. 

20 (b) AGENCY QUALITY REVIEW.— 

21 (1) IN GENERAL.—Each relevant agency within 

22 the Department of Health and Human Services shall 

23 review the statutory authority, regulations, policies, 

24 and procedures of such agency, as in effect on the 

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1 mining whether there are any deficiencies or incon2 sistencies that prohibit full compliance with the in3 tent, purposes, and provisions of this title (and the 

4 amendments made by this title). 

5 (2) PROPOSALS.—Each agency described in 

6 paragraph (1) shall, not later than July 1, 2010, 

7 submit to the Secretary of Health and Human Serv8 ices a proposal of the measures as may be necessary 

9 to bring the authority, regulations, policies, and pro10 cedures of such agency into conformity with the in11 tent, purposes, and provisions of the this title (and 

12 the amendments made by this title). 

13 SEC. 202. INTERAGENCY WORKING GROUP ON HEALTH 

14 CARE QUALITY. 

15 (a) IN GENERAL.—The President shall convene a 

16 working group to be known as the Interagency Working 

17 Group on Health Care Quality (referred to in this section 

18 as the ‘‘Working Group’’). 

19 (b) GOALS.—The goals of the Working Group shall 

20 be to achieve the following: 

21 (1) Collaboration, cooperation, and consultation 

22 between Federal departments and agencies with re23 spect to developing and disseminating strategies, 

24 goals, models, and timetables that are consistent 

25 with the national priorities identified under section 


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1 399HH(a)(2) of the Public Health Service Act (as 

2 added by section 201). 

3 (2) Avoidance of inefficient duplication of qual4 ity improvement efforts and resources, where prac5 ticable, and a streamlined process for quality report6 ing and compliance requirements. 

7 (c) COMPOSITION.— 

8 (1) IN GENERAL.—The Working Group shall be 

9 composed of senior level representatives of— 

10 (A) the Department of Health and Human 

11 Services; 

12 (B) the Department of Labor; 

13 (C) the United States Office of Personnel 

14 Management; 

15 (D) the Department of Defense; 

16 (E) the Department of Education; 

17 (F) the Department of Veterans Affairs; 

18 and 

19 (G) any other Federal agencies and depart20 ments with activities relating to improving 

21 health care quality and safety, as determined by 

22 the President. 

23 (2) CHAIR AND VICE-CHAIR.— 


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1 (A) CHAIR.—The Working Group shall be 

2 chaired by the Secretary of Health and Human 

3 Services. 

4 (B) VICE-CHAIR.—Members of the Work5 ing Group, other than the Secretary of Health 

6 and Human Services, shall serve as Vice Chair 

7 of the Group on a rotating basis, as determined 

8 by the Group. 

9 (d) REPORT TO CONGRESS.—Not later than Decem10 ber 31, 2010, and annually thereafter, the Working Group 

11 shall submit to the relevant Committees of Congress, and 

12 make public on an Internet website, a report describing 

13 the progress and recommendations of the Working Group 

14 in meeting the goals described in subsection (b). 

15 SEC. 203. QUALITY MEASURE DEVELOPMENT. 

16 Title IX of the Public Health Service Act (42 U.S.C. 

17 299 et seq.) is amended— 

18 (1) by redesignating part D as part E; 

19 (2) by redesignating sections 931 through 938 

20 as sections 941 through 948, respectively; 

21 (3) in section 948(1), as so redesignated, by 

22 striking ‘‘931’’ and inserting ‘‘941’’; and 

23 (4) by inserting after section 926 the following: 


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1 ‘‘PART D—HEALTH CARE QUALITY 

2 IMPROVEMENT 

3 ‘‘Subpart I—Quality Measure Development 

4 ‘‘SEC. 931. QUALITY MEASURE DEVELOPMENT. 

5 ‘‘(a) QUALITY MEASURE.—In this subpart, the term 

6 ‘quality measure’ means a standard for measuring the per7 formance and improvement of population health or of 

8 health plans, providers of services, and other clinicians in 

9 the delivery of health care services. 

10 ‘‘(b) IDENTIFICATION OF QUALITY MEASURES.— 

11 ‘‘(1) IDENTIFICATION.—The Director shall 

12 identify, not less often than biennially, gaps where 

13 no quality measures exist, or where existing quality 

14 measures need improvement, updating, or expansion, 

15 consistent with the national strategy under section 

16 399HH, for use in programs authorized under this 

17 Act. In identifying such gaps, the Director shall take 

18 into consideration the gaps identified by a qualified 

19 consensus-based entity under section 399JJ. 

20 ‘‘(2) PUBLICATION.—The Director shall make 

21 available to the public on an Internet website a re22 port on any gaps identified under paragraph (1) and 

23 the process used to make such identification. 

24 ‘‘(c) GRANTS OR CONTRACTS FOR QUALITY MEAS25 URE DEVELOPMENT.— 


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1 ‘‘(1) IN GENERAL.—The Director shall award 

2 grants, contracts, or intergovernmental agreements 

3 to eligible entities for purposes of developing, im4 proving, updating, or expanding quality measures 

5 identified under subsection (b). 

6 ‘‘(2) PRIORITIZATION IN THE DEVELOPMENT

7 OF QUALITY MEASURES.—In awarding grants, con8 tracts, or agreements under this subsection, the Di9 rector shall give priority to the development of qual10 ity measures that allow the assessment of— 

11 ‘‘(A) health outcomes and functional status 

12 of patients; 

13 ‘‘(B) the continuity, management, and co14 ordination of health care and care transitions, 

15 including episodes of care, for patients across 

16 the continuum of providers, health care set17 tings, and health plans; 

18 ‘‘(C) patient, caregiver, and authorized 

19 representative experience, quality and relevance 

20 of information provided to patients, caregivers, 

21 and authorized representatives, and use of in22 formation by patients, caregivers, and author23 ized representatives to inform decisionmaking 

24 about treatment options and, where appro25 priate, palliative care; 


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1 ‘‘(D) the safety, effectiveness, and timeli2 ness of care; 

3 ‘‘(E) health disparities across health dis4 parity populations (as defined in section 485E) 

5 and geographic areas; 

6 ‘‘(F) the appropriate use of health care re7 sources and services; or 

8 ‘‘(G) use of innovative strategies and meth9 odologies identified under section 933. 

10 ‘‘(3) ELIGIBLE ENTITIES.—To be eligible for a 

11 grant or contract under this subsection, an entity 

12 shall— 

13 ‘‘(A) have demonstrated expertise and ca14 pacity in the development and evaluation of 

15 quality measures; 

16 ‘‘(B) have adopted procedures to include in 

17 the quality measure development process— 

18 ‘‘(i) the views of those providers or 

19 payers whose performance will be assessed 

20 by the measure; and 

21 ‘‘(ii) the views of other parties who 

22 also will use the quality measures (such as 

23 patients, consumers, and health care pur24 chasers); 


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1 ‘‘(C) collaborate with a qualified con2 sensus-based entity (as defined in section 

3 399JJ), as practicable, and the Secretary so 

4 that quality measures developed by the eligible 

5 entity will meet the requirements to be consid6 ered for endorsement by such qualified con7 sensus-based entity; 

8 ‘‘(D) have transparent policies regarding 

9 conflicts of interest; and 

10 ‘‘(E) submit an application to the Director 

11 at such time and in such manner, as the Direc12 tor may require. 

13 ‘‘(4) USE OF FUNDS.—An entity that receives 

14 a grant, contract, or agreement under this sub15 section shall use such award to develop quality 

16 measures that meet the following requirements: 

17 ‘‘(A) Such measures build upon measures 

18 developed under section 1139A of Social Secu19 rity Act, where applicable. 

20 ‘‘(B) To the extent practicable, data on 

21 such quality measures is able to be collected 

22 using health information technologies. 

23 ‘‘(C) Each quality measure is free of 

24 charge to users of such measure. 


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1 ‘‘(D) Each quality measure is publicly 

2 available on an Internet website. 

3 ‘‘(d) OTHER ACTIVITIES BY THE DIRECTOR.—The 

4 Director may use amounts available under this section to 

5 update and test, where applicable, quality measures en6 dorsed by a qualified consensus-based entity (as defined 

7 in section 399JJ) or adopted by the Secretary. 

8 ‘‘(e) FUNDING.—There are authorized to be appro9 priated to carry out this section, $75,000,000 for each of 

10 fiscal years 2010 through 2014.’’. 

11 SEC. 204. QUALITY MEASURE ENDORSEMENT; PUBLIC RE12 PORTING; DATA COLLECTION. 

13 Title III of the Public Health Service Act (42 U.S.C. 

14 241 et seq.), as amended by section 201, is further amend15 ed by adding at the end the following: 

16 ‘‘Subpart II—Health Care Quality Programs 

17 ‘‘SEC. 399JJ. QUALITY MEASURE ENDORSEMENT. 

18 ‘‘(a) DEFINITIONS.—In this subpart: 

19 ‘‘(1) QUALIFIED CONSENSUS-BASED ENTITY.— 

20 The term ‘qualified consensus-based entity’ means 

21 an entity with a contract with the Secretary under 

22 section 1890 of the Social Security Act. 

23 ‘‘(2) QUALITY MEASURE.—The term ‘quality 

24 measure’ means a standard for measuring the per25 formance and improvement of population health or 


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1 of health plans, providers of services, and other clini2 cians in the delivery of health care services. 

3 ‘‘(3) MULTI-STAKEHOLDER GROUP.—The term 

4 ‘multi-stakeholder group’ means, with respect to a 

5 quality measure, a voluntary collaborative of organi6 zations representing a broad group of stakeholders 

7 interested in or affected by the use of such quality 

8 measure. 

9 ‘‘(b) GRANTS AND CONTRACTS.—A qualified con10 sensus-based entity may receive a grant or contract under 

11 this subsection to— 

12 ‘‘(1) make recommendations to the Secretary 

13 for national priorities for performance improvement 

14 in population health and in the delivery of health 

15 care services; 

16 ‘‘(2) identify gaps in endorsed quality measures, 

17 which shall include measures that— 

18 ‘‘(A) are within priority areas identified by 

19 the Secretary under the national strategy estab20 lished under section 399HH; 

21 ‘‘(B) assess common care episodes, patient 

22 health outcomes, processes, efficiency, cost, and 

23 appropriate use of health care services and re24 sources and address health disparities across 


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1 health disparity populations (as defined in sec2 tion 485E) and geographic areas; or 

3 ‘‘(C) assess use of innovative methodolo4 gies and strategies for quality improvement 

5 practices in the delivery of health care services 

6 that represent best practices for such quality 

7 improvement identified in section 933; 

8 ‘‘(3) identify and endorse quality measures, in9 cluding measures that address gaps identified in 

10 paragraph (2); 

11 ‘‘(4) update endorsed quality measures at least 

12 every 3 years; 

13 ‘‘(5) make endorsed quality measures publicly 

14 available and have a plan for broad-based dissemina15 tion of endorsed measures; and 

16 ‘‘(6) transmit endorsed quality measures to the 

17 Secretary. 

18 ‘‘(c) ANNUAL REPORTS.— 

19 ‘‘(1) IN GENERAL.—A qualified consensus20 based entity that receives a grant or contract under 

21 this section shall provide a report to the Secretary 

22 not less than annually— 

23 ‘‘(A) of where gaps (as described in sub24 section (b)(2)) exist and where quality measures 


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1 are unavailable or inadequate to identify or ad2 dress such gaps; and 

3 ‘‘(B) regarding areas in which evidence is 

4 insufficient to support endorsement of quality 

5 measures in priority areas identified by the Sec6 retary under the national strategy established 

7 under section 399HH and where targeted re8 search may address such gaps. 

9 ‘‘(2) IMPACT OF QUALITY MEASURES.—A quali10 fied consensus-based entity that receives a grant or 

11 contract under this section shall provide a report to 

12 the Secretary not less than annually regarding the 

13 economic and quality impact of the use of endorsed 

14 measures. 

15 ‘‘(d) PRIORITIES FOR PERFORMANCE IMPROVE16 MENT.— 

17 ‘‘(1) RECOMMENDATION FOR NATIONAL PRIOR18 ITIES.—A qualified consensus-based entity that re19 ceives a grant or contract under this section shall 

20 evaluate evidence and convene multi-stakeholder 

21 groups to make recommendations to the Secretary 

22 for national priorities for performance improvement 

23 in population health and in the delivery of health 

24 care services for consideration under the national 

25 strategy established under section 399HH. The 


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1 qualified consensus-based entity shall make such rec2 ommendations not less frequently than triennially. 

3 ‘‘(2) REQUIREMENTS FOR TRANSPARENCY IN

4 PROCESS.— 

5 ‘‘(A) IN GENERAL.—In convening multi6 stakeholder groups under paragraph (1) with 

7 respect to recommendations for national prior8 ities, the qualified consensus-based entity shall 

9 provide for an open and transparent process for 

10 the activities conducted pursuant to such con11 vening. 

12 ‘‘(B) SELECTION OF ORGANIZATIONS PAR13 TICIPATING IN MULTI-STAKEHOLDER

14 GROUPS.—The process under subparagraph (A) 

15 shall ensure that the selection of representatives 

16 comprising such groups provides for public 

17 nominations for, and the opportunity for public 

18 comment on, such selection. 

19 ‘‘(3) CONSIDERATIONS IN RECOMMENDING PRI20 ORITIES.—In making recommendations under para21 graph (1), the qualified consensus-based entity shall 

22 ensure that priority is given to areas in the delivery 

23 of health care services for all populations including 

24 children, and other vulnerable populations that— 


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1 ‘‘(A) address the health care provided to 

2 patients with prevalent, high-cost chronic dis3 eases; 

4 ‘‘(B) improve the design, development, 

5 demonstration, and adoption of infrastructure 

6 and innovative methodologies and strategies for 

7 quality improvement practices in the delivery of 

8 health care services, including those that im9 prove patient safety and reduce medical errors, 

10 readmissions, and health care-associated infec11 tions; 

12 ‘‘(C) have the greatest potential for im13 proving the health outcomes, efficiency, and pa14 tient-centeredness of health care; 

15 ‘‘(D) reduce health disparities across popu16 lations (as defined in section 485E) and geo17 graphic areas; 

18 ‘‘(E) address gaps in quality and health 

19 outcomes measures, comparative effectiveness 

20 information, and data aggregation techniques, 

21 including the use of data registries; 

22 ‘‘(F) identify areas in the delivery of 

23 health care services that have the potential for 

24 rapid improvement in the quality of patient 

25 care; and 


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1 ‘‘(G) address the appropriate use of health 

2 care technology, resources and services. 

3 ‘‘(e) PROCESS FOR CONSULTATION OF STAKE4 HOLDER GROUPS.— 

5 ‘‘(1) CONSULTATION OF SELECTION OF EN6 DORSED QUALITY MEASURES.—A qualified con7 sensus-based entity that receives a grant or contract 

8 under this section shall convene multi-stakeholder 

9 groups to provide guidance on the selection of indi10 vidual or composite quality measures, for use in re11 porting performance information to the public or for 

12 use in Federal health programs, from among— 

13 ‘‘(A) such measures that have been en14 dorsed by the qualified consensus-based entity 

15 (under section 1890(b) of the Social Security 

16 Act or otherwise); and 

17 ‘‘(B) such measures that have not been 

18 considered for endorsement by the qualified 

19 consensus-based entity but are used or proposed 

20 to be used by the Secretary under subsection 

21 (f)(2) under laws under the jurisdiction of the 

22 Secretary that require the collection or report23 ing of quality measures. 

24 ‘‘(2) TRANSMISSION OF MULTI-STAKEHOLDER

25 GUIDANCE.—The qualified consensus-based entity 


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1 shall transmit to the Secretary the guidance of 

2 multi-stakeholder groups provided under paragraph 

3 (1). 

4 ‘‘(3) REQUIREMENT FOR TRANSPARENCY IN

5 PROCESS.— 

6 ‘‘(A) IN GENERAL.—In convening multi7 stakeholder groups under paragraph (1) with 

8 respect to the selection of quality measures, the 

9 qualified consensus-based entity shall provide 

10 for an open and transparent process for the ac11 tivities conducted pursuant to such convening. 

12 ‘‘(B) SELECTION OF ORGANIZATIONS PAR13 TICIPATING IN MULTI-STAKEHOLDER

14 GROUPS.—The process under subparagraph (A) 

15 shall ensure that the selection of representatives 

16 comprising such groups provides for public 

17 nominations for, and the opportunity for public 

18 comment on, such selection. 

19 ‘‘(f) COORDINATION OF USE OF QUALITY MEAS20 URES.— 

21 ‘‘(1) ENDORSED QUALITY MEASURES.—The 

22 Secretary may make a determination under regula23 tion or otherwise to use a quality measure described 

24 in subsection (e)(1)(A) only after taking into acVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00302 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 count the guidance of multi-stakeholder groups 

2 under subsection (e)(2). 

3 ‘‘(2) USE OF INTERIM MEASURES.— 

4 ‘‘(A) IN GENERAL.—The Secretary may 

5 make a determination, by regulation or other6 wise, to use a quality measure that has not 

7 been endorsed as described in subsection 

8 (e)(1)(A), provided that the Secretary— 

9 ‘‘(i) in a timely manner, transmits the 

10 measure to the qualified consensus-based 

11 entity for consideration for endorsement 

12 and for the multi-stakeholder consultation 

13 process under subsection (e)(1); 

14 ‘‘(ii) publishes in the Federal Register 

15 the rationale for the use of the measure; 

16 and 

17 ‘‘(iii) phases out use of the measure 

18 upon a decision of the qualified consensus19 based entity not to endorse the measure, 

20 contingent on availability of an adequate 

21 alternative endorsed measure (as deter22 mined by the Secretary), taking into ac23 count guidance from multi-stakeholder con24 sultation process under subsection (e)(1). 


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1 ‘‘(B) NO ADEQUATE ALTERNATIVE.—If an 

2 adequate alternative endorsed measure is not 

3 available, the Secretary shall support the devel4 opment of such an alternative endorsed meas5 ure, as described in section 931. 

6 ‘‘(3) REQUIREMENT OF COORDINATION WITH

7 ENTITY.— 

8 ‘‘(A) REQUIREMENT FOR NOTIFICATION OF

9 ENTITY OF DEADLINE FOR RECOMMENDATIONS

10 FOR QUALITY MEASURES IN PROPOSED REGU11 LATIONS.—For each notice of proposed rule12 making to implement the collection or reporting 

13 of data on quality measures as described in sec14 tion 399LL, the Secretary shall establish a 

15 process for the regular provision of advance no16 tice to the qualified consensus-based entity of 

17 the date certain by which recommendations of 

18 the entity with respect to quality measures 

19 must be submitted to the Secretary for consid20 eration in the development of such specified 

21 regulation. 

22 ‘‘(B) TIMELY NOTICE.—Under the process 

23 established under subparagraph (A), notice 

24 shall be given to the qualified consensus-based 


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1 entity not less than 120 days before the date 

2 certain referred to in subparagraph (A). 

3 ‘‘(C) PUBLICATION OF DESCRIPTION OF

4 ENTITY RECOMMENDATIONS AND RESPONSES.— 

5 In publishing a specified regulation, the Sec6 retary shall include a description of each rec7 ommendation of the qualified consensus-based 

8 entity with respect to quality measures and 

9 shall include responses of the Secretary to each 

10 such recommendation. 

11 ‘‘(D) DEFINITION.—In this paragraph, the 

12 term ‘specified regulation’ means a notice of 

13 proposed rulemaking to implement the collec14 tion or reporting of data on quality measures as 

15 described in section 399LL. 

16 ‘‘(4) EFFECTIVE DATE.—This subsection shall 

17 apply with respect to determinations or requirements 

18 by the Secretary for the use of quality measures 

19 made on or after the date of enactment of the Af20 fordable Health Choices Act. 

21 ‘‘(g) REVIEW OF QUALITY MEASURES USED BY THE

22 SECRETARY.— 

23 ‘‘(1) IN GENERAL.—Not less than once every 3 

24 years, the Secretary shall review quality measures 


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1 used by the Secretary and, with respect to each such 

2 measure, shall determine whether to— 

3 ‘‘(A) maintain the use of such measure; or 

4 ‘‘(B) phase out such measure. 

5 ‘‘(2) CONSIDERATIONS.—In conducting the re6 view under paragraph (1), the Secretary shall— 

7 ‘‘(A) seek to avoid duplication of measures 

8 used; and 

9 ‘‘(B) take into consideration current inno10 vative methodologies and strategies for quality 

11 improvement practices in the delivery of health 

12 care services that represent best practices for 

13 such quality improvement and measures en14 dorsed by a qualified consensus-based entity 

15 since the previous review by the Secretary. 

16 ‘‘(h) PROCESS FOR DISSEMINATION OF MEASURES

17 USED BY THE SECRETARY.—The Secretary shall establish 

18 a process for disseminating quality measures used by the 

19 Secretary. Such process shall include the incorporation of 

20 such measures, where applicable, in workforce programs, 

21 training curricula, payment programs, and any other 

22 means of dissemination determined by the Secretary. The 

23 Secretary shall establish a process to disseminate such 

24 quality measures through the Interagency Working Group 


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1 established under section 202 of the Affordable Health 

2 Choices Act. 

3 ‘‘(i) FUNDING.—To carry out this section there are 

4 authorized to be appropriated $50,000,000 for each of fis5 cal years for 2010 through 2014. 

6 ‘‘SEC. 399KK. PUBLIC REPORTING OF PERFORMANCE IN7 FORMATION. 

8 ‘‘(a) REPORTING OF QUALITY MEASURES.— 

9 ‘‘(1) IN GENERAL.— 

10 ‘‘(A) REPORTING SYSTEM.—Not later than 

11 5 years after the date of enactment of the Af12 fordable Health Choices Act, and after notice 

13 and opportunity for public comment, the Sec14 retary shall implement a system for the report15 ing on quality measures that protect patient 

16 privacy and, where appropriate— 

17 ‘‘(i) assess health outcomes and func18 tional status of patients; 

19 ‘‘(ii) assess the continuity and coordi20 nation of care and care transitions, includ21 ing episodes of care, for patients across the 

22 continuum of providers and health care 

23 settings; 

24 ‘‘(iii) assess patient experience and 

25 patient, caregiver, and family engagement; 


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1 ‘‘(iv) assess the safety, effectiveness, 

2 and timeliness of care; and 

3 ‘‘(v) assess health disparities (as de4 fined by section 485E) across populations 

5 and geographic areas. 

6 ‘‘(2) FORM AND MANNER.—The data submitted 

7 under the system implemented under paragraph (1) 

8 shall be in a form and manner specified by the Sec9 retary. 

10 ‘‘(3) MEASURES DESCRIBED.—The quality 

11 measures described in paragraph (1) shall— 

12 ‘‘(A) be risk adjusted, taking into account 

13 differences in patient health status, patient 

14 characteristics, and geographic location, as ap15 propriate; 

16 ‘‘(B) be valid, reliable, evidence-based, fea17 sible to collect, and actionable by providers, 

18 payers and consumers, as appropriate; 

19 ‘‘(C) minimize the burden of collection and 

20 reporting such measures; and 

21 ‘‘(D) be consistent with the national strat22 egy established by the Secretary under section 

23 399HH. 

24 ‘‘(b) DEVELOPMENT OF PERFORMANCE

25 WEBSITES.—The Secretary shall make available to the 


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1 public performance information summarizing data on 

2 quality measures collected in subsection (a) through a se3 ries of standardized Internet websites tailored to respond 

4 to the differing needs of hospitals and other institutional 

5 providers and services, physicians and other clinicians, pa6 tients, consumers, researchers, policymakers, States, and 

7 such other stakeholders as the Secretary may specify. 

8 ‘‘(c) DESIGN.—Each standardized Internet website 

9 made available under subsection (b) shall be designed to 

10 make the use and navigation of that website readily avail11 able to individuals accessing it. The Secretary shall de12 velop a flexible format to meet the differing needs of the 

13 various stakeholders and shall modify the website to per14 mit a user to easily customize queries. 

15 ‘‘(d) INFORMATION ON CONDITIONS.—Performance 

16 information made publicly available on a standardized 

17 Internet website under subsection (b) shall be presented 

18 by, but not limited to, clinical condition to the extent such 

19 information is available, and the information presented 

20 shall, where appropriate, be provider-specific and suffi21 ciently disaggregated and specific to meet the needs of pa22 tients with different clinical conditions. 

23 ‘‘(e) CONSULTATION.—The Secretary shall carry out 

24 this section in collaboration with a qualified consensus25 based entity under section 399JJ to determine the type 


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1 of information that is useful to stakeholders and the for2 mat that best facilitates use of the reports and of perform3 ance reporting Internet websites. The qualified consensus4 based entity shall convene multi-stakeholder groups as 

5 provided in section 399JJ to review the design and format 

6 of each Internet website made available under subsection 

7 (b) and shall transmit to the Secretary the views of such 

8 multi-stakeholder groups with respect to each such design 

9 and format. 

10 ‘‘SEC. 399LL. EVALUATION OF DATA COLLECTION PROCESS 

11 FOR QUALITY MEASUREMENT. 

12 ‘‘(a) GAO EVALUATIONS.—The Comptroller General 

13 of the United States shall conduct periodic evaluations of 

14 the implementation of the data collection processes for 

15 quality measures used by the Secretary. 

16 ‘‘(b) CONSIDERATIONS.—In carrying out the evalua17 tion under subsection (a), the Comptroller General shall 

18 determine— 

19 ‘‘(1) whether the system for the collection of 

20 data for quality measures provides for validation of 

21 data as relevant, fair, and scientifically credible; 

22 ‘‘(2) whether data collection efforts under the 

23 system use the most efficient and cost-effective 

24 means in a manner that minimizes administrative 

25 burden on persons required to collect data and that 


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1 adequately protects the privacy of patients’ personal 

2 health information and provides data security; 

3 ‘‘(3) whether standards under the system pro4 vide for an opportunity for physicians and other cli5 nicians and institutional providers of services to re6 view and correct findings; and 

7 ‘‘(4) the extent to which quality measures— 

8 ‘‘(A) assess health outcomes and functional 

9 status of patients; 

10 ‘‘(B) assess the continuity and coordina11 tion of care and care transitions, including epi12 sodes of care, for patients across the continuum 

13 of providers, age, and health care settings; 

14 ‘‘(C) assess patient experience and patient, 

15 caregiver, and family engagement; 

16 ‘‘(D) assess the safety, effectiveness, and 

17 timeliness of care; 

18 ‘‘(E) assess health disparities across health 

19 disparity populations (as defined by section 

20 485E) and geographic areas; 

21 ‘‘(F) address the appropriate use of health 

22 care resources and services; 

23 ‘‘(G) are designed to be collected as part of 

24 health information technologies supporting bet25 ter delivery of health care services; 


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1 ‘‘(H) result in direct or indirect costs to 

2 users of such measures; and 

3 ‘‘(I) provide utility to both the care of indi4 viduals and the management of population 

5 health. 

6 ‘‘(c) REPORT.—The Comptroller General shall sub7 mit reports to Congress and to the Secretary containing 

8 a description of the findings and conclusions of the results 

9 of each such evaluation.’’. 

10 SEC. 205. COLLECTION AND ANALYSIS OF DATA FOR QUAL11 ITY AND RESOURCE USE MEASURES. 

12 (a) IN GENERAL.—Part S of title III of the Public 

13 Health Service Act, as amended by section 204, is further 

14 amended by adding at the end the following: 

15 ‘‘SEC. 399MM. COLLECTION AND ANALYSIS OF DATA FOR 

16 QUALITY AND RESOURCE USE MEASURES. 

17 ‘‘(a) PURPOSE.—The purpose of this section is to 

18 provide for the development of reports based on Federal 

19 health care data and private data that is publicly available 

20 or is provided by the entity making the request for the 

21 report in order to— 

22 ‘‘(1) improve the quality and efficiency of 

23 health care and advance health care research; 

24 ‘‘(2) enhance the education and awareness of 

25 consumers for evaluating health care services; and 


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1 ‘‘(3) provide the public with reports on national, 

2 regional, and provider- and supplier-specific per3 formance, which may be in a provider- or supplier4 identifiable format. 

5 ‘‘(b) ESTABLISHMENT OF PROCESS.—The Secretary 

6 shall establish a process to collect, and validate, aggregate 

7 data on quality measures described in section 399JJ to 

8 facilitate public reporting described in section 399KK. 

9 Such process shall— 

10 ‘‘(1) be developed based on guidance of a 

11 broad-based, public-private collaboration; 

12 ‘‘(2) employ methods that are scientifically 

13 sound and feasible to implement nationwide through 

14 the use of consistent methods for the collection, 

15 analysis, and reporting of quality and resource use 

16 measures; 

17 ‘‘(3) over time, where feasible, build on expand18 ing availability of health information technology and 

19 other data systems that are directly used to improve 

20 and coordinate patient care; 

21 ‘‘(4) allow for the integration of data on quality 

22 of care and resource use from a range of data 

23 sources used by providers and patients to coordinate 

24 and improve care, including public sources, private 

25 sources, and public-private collaborations; 


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1 ‘‘(5) be implemented in accordance with an ag2 gressive timeline to be established by the Secretary 

3 based on the technical and practical feasibility of 

4 measures and related data systems; and 

5 ‘‘(6) utilize clinical and claims data to evaluate 

6 the quality and efficiency of health care. 

7 ‘‘(c) DATA COLLECTION, AGGREGATION, AND ANAL8 YSIS.—The Secretary shall ensure the collection and ag9 gregation of consistent data on quality and resource use 

10 measures from information systems used to support health 

11 care delivery to implement the public reporting of perform12 ance information as described in section 399KK. The Sec13 retary shall ensure that such collection, aggregation, and 

14 analysis systems span an increasingly broad range of pa15 tient populations, providers, and geographic areas over 

16 time. 

17 ‘‘(d) GRANTS AND CONTRACTS FOR DATA COLLEC18 TION.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall award 

20 grants or contracts to eligible entities to support the 

21 collection and aggregation of quality and resource 

22 use measures described under subsection (c). 

23 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible for a 

24 grant or contract under this subsection, an entity 

25 shall— 


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1 ‘‘(A)(i) be a multi-stakeholder entity that 

2 coordinates the development of methods and 

3 implementation plans for the consistent report4 ing of summary quality and cost information; 

5 ‘‘(ii) be an entity capable of submitting 

6 such summary data for a particular population 

7 and providers, such as a disease registry, re8 gional collaboration, health plan collaboration, 

9 or other population-wide source; or 

10 ‘‘(iii) be a Federal Indian Health Service 

11 program or a health program operated by an 

12 Indian Tribe (as defined in section 4 of the In13 dian Health Care Improvement Act); 

14 ‘‘(B) promote the use of the systems that 

15 provide data to improve and coordinate patient 

16 care; 

17 ‘‘(C) support the provision of timely, con18 sistent quality and resource use information to 

19 health care providers, and other groups and or20 ganizations as appropriate, with an opportunity 

21 for providers to correct inaccurate measures; 

22 and 

23 ‘‘(D) support the provision of consistent 

24 measures on quality and resource use to the 


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1 public in accordance with the process estab2 lished by the Secretary under subsection (b). 

3 ‘‘(3) CONSISTENT DATA AGGREGATION.—The 

4 Secretary shall award funding under this subsection 

5 only to entities enabling summary data that can be 

6 integrated and compared across multiple sources. 

7 The Secretary shall also provide standards for the 

8 protection of the security and privacy of patient 

9 data. 

10 ‘‘(e) PILOT PROGRAMS TO DEVELOP, VALIDATE, AND

11 IMPROVE METHODS USED TO SUPPORT THE NATION12 WIDE QUALITY MEASUREMENT AND REPORTING STRAT13 EGY.— 

14 ‘‘(1) IN GENERAL.— 

15 ‘‘(A) DEVELOPMENT, VALIDATION, AND

16 IMPROVEMENT METHODS.—The Secretary shall 

17 support the development, validation, implemen18 tation, and refinement of nationally consistent 

19 methods used to support quality measurement 

20 and reporting under section 399KK. 

21 ‘‘(B) GRANTS AND CONTRACTS.—The Sec22 retary may award grants or contracts to eligible 

23 quality data entities to carry out subparagraph 

24 (A). 


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1 ‘‘(2) ELIGIBLE QUALITY DATA ENTITIES.—To 

2 be eligible for a grant or contract under this sub3 section, a quality data entity shall— 

4 ‘‘(A) be a public or private organization 

5 with expertise and experience in large-scale 

6 health care data aggregation, integration, anal7 ysis, or reporting; and 

8 ‘‘(B) support the implementation of quality 

9 measurement and reporting under section 

10 399KK, including the production of data that 

11 can be combined and compared with equivalent 

12 information from other entities involved in sup13 porting the delivery of care. 

14 ‘‘(f) GRANTS AND CONTRACTS FOR DATA ANAL15 YSIS.— 

16 ‘‘(1) FEDERAL HEALTH CARE DATA.—In this 

17 subsection: 

18 ‘‘(A) IN GENERAL.—Subject to subpara19 graph (B), the term ‘Federal health care data’ 

20 means— 

21 ‘‘(i) deidentified enrollment data and 

22 deidentified claims data maintained by the 

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1 standing administered by the Secretary; 

2 and 

3 ‘‘(ii) where feasible, other deidentified 

4 enrollment data and deidentified claims 

5 data maintained by the Federal Govern6 ment or entities under contract with the 

7 Federal Government. 

8 ‘‘(B) EXCEPTION.—The term ‘Federal 

9 health care data’ includes data relating to pro10 grams administered by the Secretary under the 

11 Social Security Act only to the extent that the 

12 disclosure of such data is authorized or required 

13 under such Act. 

14 ‘‘(2) AWARDS.—The Secretary shall award con15 tracts to eligible entities to support the analysis of 

16 quality and resource use measures described under 

17 subsection (c). 

18 ‘‘(3) ELIGIBLE ENTITIES.— 

19 ‘‘(A) QUALIFICATIONS.—The Secretary 

20 shall enter into a contract with an entity under 

21 paragraph (2) only if the Secretary determines 

22 that the entity— 

23 ‘‘(i) has the research capability to 

24 conduct and complete reports under this 

25 subsection; 


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1 ‘‘(ii) has in place— 

2 ‘‘(I) an information technology 

3 infrastructure to support the database 

4 of Federal health care data that is to 

5 be disclosed to the entity; and 

6 ‘‘(II) operational standards to 

7 provide security for such database; 

8 ‘‘(iii) has experience with, and exper9 tise on, the development of reports on 

10 health care quality and efficiency; and 

11 ‘‘(iv) has a significant business pres12 ence in the United States. 

13 ‘‘(B) CONTRACT REQUIREMENTS.—Each 

14 contract with an entity under paragraph (2) 

15 shall contain the following requirements: 

16 ‘‘(i) ENSURING BENEFICIARY PRI17 VACY.— 

18 ‘‘(I) HIPAA.—The entity shall 

19 meet the requirements imposed on a 

20 covered entity for purposes of apply21 ing part C of title XI and all regu22 latory provisions promulgated there23 under, including regulations (relating 

24 to privacy) adopted pursuant to the 

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1 tion 264(c) of the Health Insurance 

2 Portability and Accountability Act of 

3 1996 (42 U.S.C. 1320d–2 note). 

4 ‘‘(II) OTHER STATUTORY PRO5 TECTIONS.—The entity shall be re6 quired to refrain from disclosing data 

7 that could be withheld by the Sec8 retary under section 552 of title 5, 

9 United States Code, or whose disclo10 sure by the Secretary would violate 

11 section 552a of such title. 

12 ‘‘(ii) PROPRIETARY INFORMATION.— 

13 The entity shall provide assurances that 

14 the entity will not disclose any negotiated 

15 price concessions, such as discounts, direct 

16 or indirect subsidies, rebates, and direct or 

17 indirect remunerations, obtained by health 

18 care providers or suppliers or health care 

19 plans, or any other proprietary cost infor20 mation. 

21 ‘‘(iii) DISCLOSURE.—The entity shall 

22 disclose— 

23 ‘‘(I) any financial, reporting, or 

24 contractual relationship between the 


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1 entity and any health care provider or 

2 supplier or health care plan; and 

3 ‘‘(II) if applicable, the fact that 

4 the entity is managed, controlled, or 

5 operated by any health care provider 

6 or supplier or health care plan. 

7 ‘‘(iv) COMPONENT OF ANOTHER OR8 GANIZATION.—If the entity is a component 

9 of another organization— 

10 ‘‘(I) the entity shall maintain 

11 Federal health care data and reports 

12 separately from the rest of the organi13 zation and establish appropriate secu14 rity measures to maintain the con15 fidentiality and privacy of the Federal 

16 health care data and reports; and 

17 ‘‘(II) the entity shall not make 

18 an unauthorized disclosure to the rest 

19 of the organization of Federal health 

20 care data or reports in breach of such 

21 confidentiality and privacy require22 ment. 

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1 section is terminated or not renewed, the 

2 following requirements shall apply: 

3 ‘‘(I) CONFIDENTIALITY AND PRI4 VACY PROTECTIONS.—The entity shall 

5 continue to comply with the confiden6 tiality and privacy requirements under 

7 this subsection with respect to all 

8 Federal health care data disclosed to 

9 the entity and each report developed 

10 by the entity. 

11 ‘‘(II) DISPOSITION OF DATA AND

12 REPORTS.—The entity shall— 

13 ‘‘(aa) return to the Sec14 retary all Federal health care 

15 data disclosed to the entity and 

16 each report developed by the enti17 ty; or 

18 ‘‘(bb) if returning the Fed19 eral health care data and reports 

20 is not practicable, destroy the re21 ports and Federal health care 

22 data. 

23 ‘‘(vi) RISK ADJUSTMENT.—The entity 

24 shall ensure that the methodology used to 

25 develop a report under paragraph (4) shall 


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1 include acceptable risk adjustment and 

2 case-mix adjustment developed in consulta3 tion with providers. 

4 ‘‘(C) COMPETITIVE PROCEDURES.—Com5 petitive procedures (as defined in section 4(5) 

6 of the Federal Procurement Policy Act) shall be 

7 used to enter into contracts under paragraph 

8 (2). 

9 ‘‘(D) REVIEW OF CONTRACT IN EVENT OF

10 A MERGER OR ACQUISITION.—The Secretary 

11 shall review the contract with an entity receiv12 ing a contract under this subsection in the 

13 event of a merger or acquisition of the entity in 

14 order to ensure that the requirements under 

15 this subsection will continue to be met. 

16 ‘‘(4) PROCEDURES FOR THE DEVELOPMENT OF

17 REPORTS.—Notwithstanding section 552(b)(6) or 

18 552a(b) of title 5, United States Code, subject to 

19 paragraph (1)(B), not later than 12 months after 

20 the date of enactment of this section, the Secretary, 

21 in accordance with the purpose described in sub22 section (a), shall establish and implement procedures 

23 under which an entity may submit a request to an 

24 entity with a contract under this subsection to de25 velop a report based on— 


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1 ‘‘(A) Federal health care data disclosed to 

2 the entity under paragraph (5); and 

3 ‘‘(B) private data that is publicly available 

4 or is provided to the entity by the entity mak5 ing the request for the report. 

6 ‘‘(5) ACCESS TO FEDERAL HEALTH CARE

7 DATA.— 

8 ‘‘(A) IN GENERAL.—The procedures estab9 lished under paragraph (4) shall provide for the 

10 secure disclosure of Federal health care data to 

11 each entity with a contract under paragraph 

12 (2). 

13 ‘‘(B) UPDATE INFORMATION.—Not less 

14 than every 6 months, the Secretary shall update 

15 the information disclosed under subparagraph 

16 (A) to each such entity. 

17 ‘‘(g) PUBLIC REPORTING OF QUALITY RESOURCE

18 USE MEASURES AT THE PROVIDER, GROUP, SYSTEM, RE19 GIONAL, AND OTHER LEVELS.—The Secretary shall make 

20 aggregated data, and reports developed under subsection 

21 (f), on quality and resource use measures collected under 

22 this section available to health care providers and the pub23 lic through the process described in 399KK. 

24 ‘‘(h) RESEARCH ACCESS TO HEALTH CARE DATA

25 AND REPORTING ON PERFORMANCE.—The Secretary 


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1 shall permit researchers that meet criteria used to evalu2 ate the appropriateness of the release data for research 

3 purposes (as established by the Secretary) to— 

4 ‘‘(1) have access to Federal health care data (as 

5 defined in subsection (f)); and 

6 ‘‘(2) report on the performance of health care 

7 providers and suppliers, including reporting in a 

8 provider- or supplier-identifiable format. 

9 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There 

10 are authorized to be appropriated to carry out this section 

11 $90,000,000 for each of fiscal years 2010 through 2014.’’. 

12 (b) HIT POLICY COMMITTEE.—Section 

13 3002(b)(2)(B) of the Public Health Service Act (42 

14 U.S.C. 300jj–12(b)(2)(B)) is amended by adding at the 

15 end the following: 

16 ‘‘(ix) The use of certified electronic 

17 health records to collect and report quality 

18 measures accepted by the Secretary.’’. 


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1 Subtitle B—Health Care Quality 

2 Improvements 

3 SEC. 211. HEALTH CARE DELIVERY SYSTEM RESEARCH; 

4 QUALITY IMPROVEMENT TECHNICAL ASSIST5 ANCE. 

6 Part D of title IX of the Public Health Service Act, 

7 as amended by section 203, is further amended by adding 

8 at the end the following: 

9 ‘‘Subpart II—Health Care Quality Improvement 

10 Programs 

11 ‘‘SEC. 933. HEALTH CARE DELIVERY SYSTEM RESEARCH. 

12 ‘‘(a) PURPOSE.—The purposes of this section are 

13 to— 

14 ‘‘(1) enable the Director to identify, develop, 

15 evaluate, disseminate, and provide training in inno16 vative methodologies and strategies for quality im17 provement practices in the delivery of health care 

18 services that represent best practices (referred to as 

19 ‘best practices’) in health care quality, safety, and 

20 value; and 

21 ‘‘(2) ensure that the Director is accountable for 

22 implementing a model to pursue such research in a 

23 collaborative manner with other related Federal 

24 agencies. 


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1 ‘‘(b) ESTABLISHMENT OF CENTER.—There is estab2 lished within the Agency the Patient Safety Research Cen3 ter (referred to in this section as the ‘Center’). 

4 ‘‘(c) GENERAL FUNCTIONS OF CENTER.—The Center 

5 shall— 

6 ‘‘(1) carry out its functions using research from 

7 a variety of disciplines, which may include epidemi8 ology, health services, sociology, psychology, human 

9 factors engineering, biostatistics, health economics, 

10 clinical research, and health informatics; 

11 ‘‘(2) conduct or support activities for activities 

12 identified in subsection (a), and for— 

13 ‘‘(A) best practices for quality improve14 ment practices in the delivery of health care 

15 services; and 

16 ‘‘(B) that include changes in processes of 

17 care and the redesign of systems used by pro18 viders that will reliably result in intended health 

19 outcomes, improve patient safety, and reduce 

20 medical errors (such as skill development for 

21 health care providers in team-based health care 

22 delivery and rapid cycle process improvement) 

23 and facilitate adoption of improved workflow; 


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1 ‘‘(3) identify health care providers, including 

2 health care systems, single institutions, and indi3 vidual providers, that— 

4 ‘‘(A) deliver consistently high-quality, effi5 cient health care services (as determined by the 

6 Secretary); and 

7 ‘‘(B) employ best practices that are adapt8 able and scalable to diverse health care settings 

9 or effective in improving care across diverse set10 tings; 

11 ‘‘(4) assess research, evidence, and knowledge 

12 about what strategies and methodologies are most 

13 effective in improving health care delivery; 

14 ‘‘(5) find ways to translate such information 

15 rapidly and effectively into practice, and document 

16 the sustainability of those improvements; 

17 ‘‘(6) create strategies for quality improvement 

18 through the development of tools, methodologies, 

19 and interventions that can successfully reduce vari20 ations in the delivery of health care; 

21 ‘‘(7) identify, measure, and improve organiza22 tional, human, or other causative factors, including 

23 those related to the culture and system design of a 

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1 cess and sustainability of specific quality improve2 ment and patient safety strategies; 

3 ‘‘(8) provide for the development of best prac4 tices in the delivery of health care services that— 

5 ‘‘(A) have a high likelihood of success, 

6 based on structured review of empirical evi7 dence; 

8 ‘‘(B) are specified with sufficient detail of 

9 the individual processes, steps, training, skills, 

10 and knowledge required for implementation and 

11 incorporation into workflow of health care prac12 titioners in a variety of settings; 

13 ‘‘(C) are designed to be readily adapted by 

14 health care providers in a variety of settings; 

15 and 

16 ‘‘(D) where applicable, assist health care 

17 providers in working with other health care pro18 viders across the continuum of care and in en19 gaging patients and their families in improving 

20 the care and patient health outcomes; 

21 ‘‘(9) provide for the funding of the activities of 

22 organizations with recognized expertise and excel23 lence in improving the delivery of health care serv24 ices, including children’s health care, by involving 

25 multiple disciplines, managers of health care entities, 


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1 broad development and training, patients, caregivers 

2 and families, and frontline health care workers, in3 cluding activities for the examination of strategies to 

4 share best quality improvement practices and to pro5 mote excellence in the delivery of health care serv6 ices; and 

7 ‘‘(10) build capacity at the State and commu8 nity level to lead quality and safety efforts through 

9 education, training, and mentoring programs to 

10 carry out the activities under paragraphs (1) 

11 through (9). 

12 ‘‘(d) RESEARCH FUNCTIONS OF CENTER.— 

13 ‘‘(1) IN GENERAL.—The Center shall support, 

14 such as through a contract or other mechanism, re15 search on health care delivery system improvement 

16 and the development of tools to facilitate adoption of 

17 best practices that improve the quality, safety, and 

18 efficiency of health care delivery services. Such sup19 port may include establishing a Quality Improve20 ment Network Research Program for the purpose of 

21 testing, scaling, and disseminating of interventions 

22 to improve quality and efficiency in health care. Re23 cipients of funding under the Program may include 

24 national, State, multi-State, or multi-site quality im25 provement networks. 


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1 ‘‘(2) RESEARCH REQUIREMENTS.—The re2 search conducted pursuant to paragraph (1) shall— 

3 ‘‘(A) address the priorities identified by 

4 the Secretary in the national strategic plan es5 tablished under section 399HH; 

6 ‘‘(B) identify areas in which evidence is in7 sufficient to identify strategies and methodolo8 gies, taking into consideration areas of insuffi9 cient evidence identified by a qualified con10 sensus-based entity in the report required under 

11 section 399JJ; 

12 ‘‘(C) address concerns identified by health 

13 care institutions and providers and commu14 nicated through the Center pursuant to sub15 section (e); 

16 ‘‘(D) reduce preventable morbidity, mor17 tality, and associated costs of morbidity and 

18 mortality by building capacity for patient safety 

19 research; 

20 ‘‘(E) support the discovery of processes for 

21 the reliable, safe, efficient, and responsive deliv22 ery of health care, taking into account discov23 eries from clinical research and comparative ef24 fectiveness research; 


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1 ‘‘(F) be designed to help improve health 

2 care quality and is tested in practice-based set3 tings; 

4 ‘‘(G) allow communication of research find5 ings and translate evidence into practice rec6 ommendations that are adaptable to a variety 

7 of settings, and which, as soon as practicable 

8 after the establishment of the Center, shall in9 clude— 

10 ‘‘(i) the implementation of a national 

11 application of Intensive Care Unit improve12 ment projects relating to the adult (includ13 ing geriatric), pediatric, and neonatal pa14 tient populations; 

15 ‘‘(ii) practical methods for addressing 

16 health care associated infections, including 

17 Methicillin–Resistant Staphylococcus 

18 Aureus and Vancomycin–Resistant 

19 Entercoccus infections and other emerging 

20 infections; and 

21 ‘‘(iii) practical methods for reducing 

22 preventable hospital admissions and re23 admissions; 

24 ‘‘(H) expand demonstration projects for 

25 improving the quality of children’s health care 


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1 and the use of health information technology, 

2 such as through Pediatric Quality Improvement 

3 Collaboratives and Learning Networks, con4 sistent with provisions of section 1139A of the 

5 Social Security Act for assessing and improving 

6 quality, where applicable; 

7 ‘‘(I) identify and mitigate hazards by— 

8 ‘‘(i) analyzing events reported to pa9 tient safety reporting systems and patient 

10 safety organizations; and 

11 ‘‘(ii) using the results of such analyses 

12 to develop scientific methods of response to 

13 such events; 

14 ‘‘(J) include the conduct of systematic re15 views of existing practices that improve the 

16 quality, safety, and efficiency of health care de17 livery, as well as new research on improving 

18 such practices; and 

19 ‘‘(K) include the examination of how to 

20 measure and evaluate the progress of quality 

21 and patient safety activities. 

22 ‘‘(e) DISSEMINATION OF RESEARCH FINDINGS.— 

23 ‘‘(1) PUBLIC AVAILABILITY.—The Director 

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1 priate formats to reflect the varying needs of health 

2 care providers and consumers and diverse levels of 

3 health literacy. 

4 ‘‘(2) LINKAGE TO HEALTH INFORMATION TECH5 NOLOGY.—The Secretary shall ensure that research 

6 findings and results generated by the Center are 

7 shared with the Office of the National Coordinator 

8 of Health Information Technology and used to in9 form the activities of the health information tech10 nology extension program under section 3012, as 

11 well as any relevant standards, certification criteria, 

12 or implementation specifications. 

13 ‘‘(f) PRIORITIZATION.—The Director shall identify 

14 and regularly update a list of processes or systems on 

15 which to focus research and dissemination activities of the 

16 Center, taking into account— 

17 ‘‘(1) cost to Federal health programs; 

18 ‘‘(2) consumer assessment of health care experi19 ence; 

20 ‘‘(3) provider assessment of such processes or 

21 systems and opportunities to minimize distress and 

22 injury to the health care workforce; 

23 ‘‘(4) potential impact of such processes or sys24 tems on health status and function of patients, in25 cluding vulnerable populations including children; 


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1 ‘‘(5) areas of insufficient evidence identified 

2 under subsection (d)(2)(B); and 

3 ‘‘(6) the evolution of meaningful use of health 

4 information technology, as defined in section 3000. 

5 ‘‘(g) FUNDING.—There is authorized to be appro6 priated to carry out this section $20,000,000 for fiscal 

7 years 2010 through 2014. 

8 ‘‘SEC. 934. QUALITY IMPROVEMENT TECHNICAL ASSIST9 ANCE AND IMPLEMENTATION. 

10 ‘‘(a) IN GENERAL.—The Director, through the Pa11 tient Safety Research Center established in section 933 

12 (referred to in this section as the ‘Center’), shall award— 

13 ‘‘(1) technical assistance grants or contracts to 

14 eligible entities to provide technical support to insti15 tutions that deliver health care and health care pro16 viders so that such institutions and providers under17 stand, adapt, and implement the models and prac18 tices identified in the research conducted by the 

19 Center, including the Quality Improvement Net20 works Research Program; and 

21 ‘‘(2) implementation grants or contracts to eli22 gible entities to implement the models and practices 

23 described under paragraph (1). 

24 ‘‘(b) ELIGIBLE ENTITIES.— 


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1 ‘‘(1) TECHNICAL ASSISTANCE AWARD.—To be 

2 eligible to receive a technical assistance grant or 

3 contract under subsection (a)(1), an entity— 

4 ‘‘(A) may be a health care provider, health 

5 care provider association, professional society, 

6 health care worker organization, Indian health 

7 organization, quality improvement organization, 

8 patient safety organization, local quality im9 provement collaborative, the Joint Commission, 

10 academic health center, university, physician11 based research network, primary care extension 

12 program established under section 399V, a Fed13 eral Indian Health Service program or a health 

14 program operated by an Indian Tribe (as de15 fined in section 4 of the Indian Health Care 

16 Improvement Act), or any other entity identi17 fied by the Secretary; and 

18 ‘‘(B) shall have demonstrated expertise in 

19 providing information and technical support 

20 and assistance to health care providers regard21 ing quality improvement. 

22 ‘‘(2) IMPLEMENTATION AWARD.—To be eligible 

23 to receive an implementation grant or contract 

24 under subsection (a)(2), an entity— 


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1 ‘‘(A) may be a hospital or other health 

2 care provider or consortium or providers, as de3 termined by the Secretary; and 

4 ‘‘(B) shall have demonstrated expertise in 

5 providing information and technical support 

6 and assistance to health care providers regard7 ing quality improvement. 

8 ‘‘(c) APPLICATION.— 

9 ‘‘(1) TECHNICAL ASSISTANCE AWARD.—To re10 ceive a technical assistance grant or contract under 

11 subsection (a)(1), an eligible entity shall submit an 

12 application to the Secretary at such time, in such 

13 manner, and containing— 

14 ‘‘(A) a plan for a sustainable business 

15 model that may include a system of— 

16 ‘‘(i) charging fees to institutions and 

17 providers that receive technical support 

18 from the entity; and 

19 ‘‘(ii) reducing or eliminating such fees 

20 for such institutions and providers that 

21 serve low-income populations; and 

22 ‘‘(B) such other information as the Direc23 tor may require. 

24 ‘‘(2) IMPLEMENTATION AWARD.—To receive a 

25 grant or contract under subsection (a)(2), an eligible 


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1 entity shall submit an application to the Secretary at 

2 such time, in such manner, and containing— 

3 ‘‘(A) a plan for implementation of a model 

4 or practice identified in the research conducted 

5 by the Center including— 

6 ‘‘(i) financial cost, staffing require7 ments, and timeline for implementation; 

8 and 

9 ‘‘(ii) pre- and projected post-imple10 mentation quality measure performance 

11 data in targeted improvement areas identi12 fied by the Secretary; and 

13 ‘‘(B) such other information as the Direc14 tor may require. 

15 ‘‘(d) MATCHING FUNDS.—The Director may not 

16 award a grant or contract under this section to an entity 

17 unless the entity agrees that it will make available (di18 rectly or through contributions from other public or pri19 vate entities) non-Federal contributions toward the activi20 ties to be carried out under the grant or contract in an 

21 amount equal to $1 for each $5 of Federal funds provided 

22 under the grant or contract. Such non-Federal matching 

23 funds may be provided directly or through donations from 

24 public or private entities and may be in cash or in-kind, 

25 fairly evaluated, including plant, equipment, or services. 


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1 ‘‘(e) EVALUATION.— 

2 ‘‘(1) IN GENERAL.—The Director shall evaluate 

3 the performance of each entity that receives a grant 

4 or contract under this section. The evaluation of an 

5 entity shall include a study of— 

6 ‘‘(A) the success of such entity in achiev7 ing the implementation, by the health care in8 stitutions and providers assisted by such entity, 

9 of the models and practices identified in the re10 search conducted by the Center under section 

11 933; 

12 ‘‘(B) the perception of the health care in13 stitutions and providers assisted by such entity 

14 regarding the value of the entity; and 

15 ‘‘(C) where practicable, better patient 

16 health outcomes and lower cost resulting from 

17 the assistance provided by such entity. 

18 ‘‘(2) EFFECT OF EVALUATION.—Based on the 

19 outcome of the evaluation of the entity under para20 graph (1), the Director shall determine whether to 

21 renew a grant or contract with such entity under 

22 this section. 

23 ‘‘(f) COORDINATION.—The entities that receive a 

24 grant or contract under this section shall coordinate with 

25 health information technology regional extension centers 


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1 under section 3012(c) and the primary care extension pro2 gram established under section 399V regarding the dis3 semination of quality improvement, system delivery re4 form, and best practices information.’’. 

5 SEC. 212. GRANTS TO ESTABLISH COMMUNITY HEALTH 

6 TEAMS TO SUPPORT THE PATIENT-CEN7 TERED MEDICAL HOME. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this section as the ‘‘Sec10 retary’’) shall establish a program to provide grants to eli11 gible entities to establish community-based interdiscipli12 nary, interprofessional teams (referred to in this section 

13 as ‘‘health teams’’) to support primary care practices, in14 cluding obstetrics and gynecology practices, within the 

15 hospital service areas served by the eligible entities. 

16 Grants shall be used to— 

17 (1) establish health teams to provide support 

18 services to primary care providers; and 

19 (2) provide capitated payments to primary care 

20 providers as determined by the Secretary. 

21 (b) ELIGIBLE ENTITIES.—To be eligible to receive a 

22 grant under subsection (a), an entity shall— 

23 (1)(A) be a State or State-designated entity; or 


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1 ø(B) be an Indian Tribe or tribal organization, 

2 as defined in section 4 of the Indian Health Care 

3 Improvement Act;¿ 

4 (2) submit a plan for achieving long-term finan5 cial sustainability within 3 years; 

6 (3) submit a plan for incorporating prevention 

7 initiatives and patient education and care manage8 ment resources into the delivery of health care that 

9 is integrated with community-based prevention and 

10 treatment resources, where available; 

11 (4) ensure that the health team established by 

12 the entity includes an interdisciplinary, interprofes13 sional team of health care providers, as determined 

14 by the Secretary; such team may include medical 

15 specialists, nurses, nutritionists, dieticians, social 

16 workers, behavioral and mental health providers (in17 cluding substance use disorder prevention and treat18 ment providers), doctors of chiropractic, licensed 

19 complementary and alternative medicine practi20 tioners, and physicians’ assistants; and 

21 (5) submit to the Secretary an application at 

22 such time, in such manner, and containing such in23 formation as the Secretary may require. 


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1 (c) REQUIREMENTS FOR HEALTH TEAMS.—A health 

2 team established pursuant to a grant under subsection (a) 

3 shall— 

4 (1) establish contractual agreements with pri5 mary care providers to provide support services; 

6 (2) support patient-centered medical homes, de7 fined as mode of care that includes— 

8 (A) personal physicians; 

9 (B) whole person orientation; 

10 (C) coordinated and integrated care; 

11 (D) safe and high quality care though evi12 dence-informed medicine, appropriate use of 

13 health information technology, and continuous 

14 quality improvements; 

15 (E) expanded access to care; and 

16 (F) payment that recognizes added value 

17 from additional components of patient-centered 

18 care; 

19 (3) collaborate with local primary care providers 

20 and existing State and community based resources 

21 to coordinate disease prevention, chronic disease 

22 management, transitioning between health care pro23 viders and settings and case management for pa24 tients, including children, with priority given to 


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1 those amenable to prevention and with chronic dis2 eases or conditions identified by the Secretary; 

3 (4) in collaboration with local health care pro4 viders, develop and implement interdisciplinary, 

5 interprofessional care plans that integrate clinical 

6 and community preventive and health promotion 

7 services for patients, including children, with a pri8 ority given to those amenable to prevention and with 

9 chronic diseases or conditions identified by the Sec10 retary; 

11 (5) incorporate health care providers, patients, 

12 caregivers, and authorized representatives in pro13 gram design and oversight; 

14 (6) provide support necessary for local primary 

15 care providers to— 

16 (A) coordinate and provide access to high17 quality health care services; 

18 (B) coordinate and provide access to pre19 ventive and health promotion services; 

20 (C) provide access to appropriate specialty 

21 care and inpatient services; 

22 (D) provide quality-driven, cost-effective, 

23 culturally appropriate, and patient- and family24 centered health care; 


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1 (E) provide access to pharmacist-delivered 

2 medication management services, including 

3 medication reconciliation; 

4 (F) provide coordination of the appropriate 

5 use of complementary and alternative (CAM) 

6 services to those who request such services; 

7 (G) promote effective strategies for treat8 ment planning, monitoring health outcomes and 

9 resource use, sharing information, treatment 

10 decision support, and organizing care to avoid 

11 duplication of service and other medical man12 agement approaches intended to improve qual13 ity and value of health care services; 

14 (H) provide local access to the continuum 

15 of health care services in the most appropriate 

16 setting, including access to individuals that im17 plement the care plans of patients and coordi18 nate care, such as integrative health care prac19 titioners; 

20 (I) collect and report data that permits 

21 evaluation of the success of the collaborative ef22 fort on patient outcomes, including collection of 

23 data on patient experience of care, and identi24 fication of areas for improvement; and 


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1 (J) establish a coordinated system of early 

2 identification and referral for children at risk 

3 for developmental or behavioral problems such 

4 as through the use of infolines, health informa5 tion technology, or other means as determined 

6 by the Secretary; 

7 (7) provide 24-hour care management and sup8 port during transitions in care settings including— 

9 (A) a transitional care program that pro10 vides onsite visits from the care coordinator, as11 sists with the development of discharge plans 

12 and medication reconciliation upon admission to 

13 and discharge from the hospitals, nursing home, 

14 or other institution setting; 

15 (B) discharge planning and counseling 

16 support to providers, patients, caregivers, and 

17 authorized representatives; 

18 (C) assuring that post-discharge care plans 

19 include medication management, as appro20 priate; 

21 (D) referrals for mental and behavioral 

22 health services, which may include the use of 

23 infolines; and 

24 (E) transitional health care needs from 

25 adolescence to adulthood; 


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1 (8) serve as a liaison to community prevention 

2 and treatment programs; 

3 (9) demonstrate a capacity to implement and 

4 maintain health information technology that meets 

5 the requirements of certified EHR technology (as 

6 defined in section 3000 of the Public Health Service 

7 Act (42 U.S.C. 300jj)) to facilitate coordination 

8 among members of the applicable care team and af9 filiated primary care practices; and 

10 (10) where applicable, report to the Secretary 

11 information on quality measures used under section 

12 399JJ of the Public Health Service Act. 

13 (d) REQUIREMENT FOR PRIMARY CARE PRO14 VIDERS.—A provider who contracts with a care team 

15 shall— 

16 (1) provide a care plan to the care team for 

17 each patient participant; 

18 (2) provide access to participant health records; 

19 and 

20 (3) meet regularly with the care team to ensure 

21 integration of care. 

22 (e) REPORTING TO SECRETARY.—An entity that re23 ceives a grant under subsection (a) shall submit to the 

24 Secretary a report that describes and evaluates, as reVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00346 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 quested by the Secretary, the activities carried out by the 

2 entity under subsection (c). 

3 (f) DEFINITION OF PRIMARY CARE.—In this section, 

4 the term ‘‘primary care’’ means the provision of inte5 grated, accessible health care services by clinicians who 

6 are accountable for addressing a large majority of personal 

7 health care needs, developing a sustained partnership with 

8 patients, and practicing in the context of family and com9 munity. 

10 SEC. 213. GRANTS TO IMPLEMENT MEDICATION MANAGE11 MENT SERVICES IN TREATMENT OF CHRONIC 

12 DISEASE. 

13 Title IX of the Public Health Service Act (42 U.S.C. 

14 299 et seq.), as amended by section 211, is further amend15 ed by inserting after section 934 the following: 

16 ‘‘SEC. 935. GRANTS TO IMPLEMENT MEDICATION MANAGE17 MENT SERVICES IN TREATMENT OF CHRONIC 

18 DISEASES. 

19 ‘‘(a) IN GENERAL.—The Secretary, acting through 

20 the Patient Safety Research Center established in section 

21 933 (referred to in this section as the ‘Center’), shall es22 tablish a program to provide grants to eligible entities to 

23 implement medication management (referred to in this 

24 section as ‘MTM’) services provided by licensed phar25 macists, as a collaborative, multidisciplinary, inter-profesVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00347 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 sional approach to the treatment of chronic diseases for 

2 targeted individuals, to improve the quality of care and 

3 reduce overall cost in the treatment of such diseases. The 

4 Secretary shall commence the grant program not later 

5 than May 1, 2010. 

6 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 

7 a grant under subsection (a), an entity shall— 

8 ‘‘(1) provide a setting appropriate for MTM 

9 services, as recommended by the experts described in 

10 subsection (e); 

11 ‘‘(2) submit to the Secretary a plan for achiev12 ing long-term financial sustainability; 

13 ‘‘(3) where applicable, submit a plan for coordi14 nating MTM services through local community 

15 health teams established in section 212 of the Af16 fordable Health Choices Act or in collaboration with 

17 primary care extension programs established in sec18 tion 399V; 

19 ‘‘(4) submit a plan for meeting the require20 ments under subsection (c); and 

21 ‘‘(5) submit to the Secretary such other infor22 mation as the Secretary may require. 

23 ‘‘(c) MTM SERVICES TO TARGETED INDIVIDUALS.— 

24 The MTM services provided with the assistance of a grant 

25 awarded under subsection (a) shall, as allowed by State 


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1 law including applicable collaborative pharmacy practice 

2 agreements, include— 

3 ‘‘(1) performing or obtaining necessary assess4 ments of the health and functional status of each 

5 patient receiving such MTM services; 

6 ‘‘(2) formulating a medication treatment plan 

7 according to therapeutic goals agreed upon by the 

8 prescriber and the patient or caregiver or authorized 

9 representative of the patient; 

10 ‘‘(3) selecting, initiating, modifying, recom11 mending changes to, or administering medication 

12 therapy; 

13 ‘‘(4) monitoring, which may include access to, 

14 ordering, or performing laboratory assessments, and 

15 evaluating the response of the patient to therapy, in16 cluding safety and effectiveness; 

17 ‘‘(5) performing an initial comprehensive medi18 cation review to identify, resolve, and prevent medi19 cation-related problems, including adverse drug 

20 events, quarterly targeted medication reviews for on21 going monitoring, and additional followup interven22 tions on a schedule developed collaboratively with 

23 the prescriber; 

24 ‘‘(6) documenting the care delivered and com25 municating essential information about such care, 


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1 including a summary of the medication review, and 

2 the recommendations of the pharmacist to other ap3 propriate health care providers of the patient in a 

4 timely fashion; 

5 ‘‘(7) providing education and training designed 

6 to enhance the understanding and appropriate use of 

7 the medications by the patient, caregiver, and other 

8 authorized representative; 

9 ‘‘(8) providing information, support services, 

10 and resources and strategies designed to enhance 

11 patient adherence with therapeutic regimens; 

12 ‘‘(9) coordinating and integrating MTM serv13 ices within the broader health care management 

14 services provided to the patient; and 

15 ‘‘(10) such other patient care services allowed 

16 under pharmacist scopes of practice in use in other 

17 Federal programs that have implemented MTM 

18 services. 

19 ‘‘(d) TARGETED INDIVIDUALS.—MTM services pro20 vided by licensed pharmacists under a grant awarded 

21 under subsection (a) shall be offered to targeted individ22 uals who— 

23 ‘‘(1) take 4 or more prescribed medications (in24 cluding over-the-counter medications and dietary 

25 supplements); 


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1 ‘‘(2) take any ‘high risk’ medications; 

2 ‘‘(3) have 2 or more chronic diseases, as identi3 fied by the Secretary; or 

4 ‘‘(4) have undergone a transition of care, or 

5 other factors, as determined by the Secretary, that 

6 are likely to create a high risk of medication-related 

7 problems. 

8 ‘‘(e) CONSULTATION WITH EXPERTS.—In designing 

9 and implementing MTM services provided under grants 

10 awarded under subsection (a), the Secretary shall consult 

11 with Federal, State, private, public-private, and academic 

12 entities, pharmacy and pharmacist organizations, health 

13 care organizations, consumer advocates, chronic disease 

14 groups, and other stakeholders involved with the research, 

15 dissemination, and implementation of pharmacist-deliv16 ered MTM services, as the Secretary determines appro17 priate. The Secretary, in collaboration with this group, 

18 shall determine whether it is possible to incorporate rapid 

19 cycle process improvement concepts in use in other Fed20 eral programs that have implemented MTM services. 

21 ‘‘(f) REPORTING TO THE SECRETARY.—An entity 

22 that receives a grant under subsection (a) shall submit to 

23 the Secretary a report that describes and evaluates, as re24 quested by the Secretary, the activities carried out under 


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1 subsection (c), including quality measures endorsed under 

2 399JJ, as determined by the Secretary. 

3 ‘‘(g) EVALUATION AND REPORT.—The Secretary 

4 shall submit to the relevant committees of Congress a re5 port which shall— 

6 ‘‘(1) assess the clinical effectiveness of phar7 macist-provided services under the MTM services 

8 program, as compared to usual care, including an 

9 evaluation of whether enrollees maintained better 

10 health with fewer hospitalizations and emergency 

11 room visits than similar patients not enrolled in the 

12 program; 

13 ‘‘(2) assess changes in overall health care re14 source use by targeted individuals; 

15 ‘‘(3) assess patient and prescriber satisfaction 

16 with MTM services; 

17 ‘‘(4) assess the impact of patient-cost sharing 

18 requirements on medication adherence and rec19 ommendations for modifications; 

20 ‘‘(5) identify and evaluate other factors that 

21 may impact clinical and economic outcomes, includ22 ing demographic characteristics, clinical characteris23 tics, and health services use of the patient, as well 

24 as characteristics of the regimen, pharmacy benefit, 

25 and MTM services provided; and 


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1 ‘‘(6) evaluate the extent to which participating 

2 pharmacists who maintain a dispensing role have a 

3 conflict of interest in the provision of MTM services, 

4 and if such conflict is found, provide recommenda5 tions on how such a conflict might be appropriately 

6 addressed. 

7 ‘‘(h) GRANT TO FUND DEVELOPMENT OF PERFORM8 ANCE MEASURES.—Secretary may, through the quality 

9 measure development program under section 931 of the 

10 Public Health Service Act, award grants or contracts to 

11 eligible entities for the purpose of funding the development 

12 of performance measures that assess the use and effective13 ness of medication therapy management services.’’. 

14 SEC. 214. DESIGN AND IMPLEMENTATION OF REGIONAL15 IZED SYSTEMS FOR EMERGENCY CARE. 

16 (a) IN GENERAL.—Title XII of the Public Health 

17 Service Act (42 U.S.C. 300d et seq.) is amended— 

18 (1) in section 1203— 

19 (A) in the section heading, by inserting 

20 ‘‘FOR TRAUMA SYSTEMS’’ after ‘‘GRANTS’’; 

21 and 

22 (B) in subsection (a), by striking ‘‘Admin23 istrator of the Health Resources and Services 

24 Administration’’ and inserting ‘‘Assistant Sec25 retary for Preparedness and Response’’; 


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1 (2) by inserting after section 1203 the fol2 lowing: 

3 ‘‘SEC. 1204. COMPETITIVE GRANTS FOR REGIONALIZED SYS4 TEMS FOR EMERGENCY CARE RESPONSE. 

5 ‘‘(a) IN GENERAL.—The Secretary, acting through 

6 the Assistant Secretary for Preparedness and Response, 

7 shall award not fewer than 4 multiyear contracts or com8 petitive grants to eligible entities to support pilot projects 

9 that design, implement, and evaluate innovative models of 

10 regionalized, comprehensive, and accountable emergency 

11 care and trauma systems. 

12 ‘‘(b) ELIGIBLE ENTITY; REGION.—In this section: 

13 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en14 tity’ means— 

15 ‘‘(A) a State or a partnership of 1 or more 

16 States and 1 or more local governments; or 

17 ‘‘(B) an Indian Tribe (as defined in section 

18 4 of the Indian Health Care Improvement Act) 

19 or a partnership of 1 or more Indian Tribes. 

20 ‘‘(2) REGION.—The term ‘region’ means an 

21 area within a State, an area that lies within multiple 

22 States, or a similar area (such as a multicounty 

23 area), as determined by the Secretary. 


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1 ‘‘(3) EMERGENCY SERVICES.—The term ‘emer2 gency services’ includes acute, prehospital, and trau3 ma care. 

4 ‘‘(c) PILOT PROJECTS.—The Secretary shall award 

5 a contract or grant under subsection (a) to an eligible enti6 ty that proposes a pilot project to design, implement, and 

7 evaluate an emergency medical and trauma system that— 

8 ‘‘(1) coordinates with public health and safety 

9 services, emergency medical services, medical facili10 ties, trauma centers, and other entities in a region 

11 to develop an approach to emergency medical and 

12 trauma system access throughout the region, includ13 ing 9–1–1 Public Safety Answering Points and 

14 emergency medical dispatch; 

15 ‘‘(2) includes a mechanism, such as a regional 

16 medical direction or transport communications sys17 tem, that operates throughout the region to ensure 

18 that the patient is taken to the medically appro19 priate facility (whether an initial facility or a higher20 level facility) in a timely fashion; 

21 ‘‘(3) allows for the tracking of prehospital and 

22 hospital resources, including inpatient bed capacity, 

23 emergency department capacity, trauma center ca24 pacity, on-call specialist coverage, ambulance diver25 sion status, and the coordination of such tracking 


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1 with regional communications and hospital destina2 tion decisions; and 

3 ‘‘(4) includes a consistent region-wide 

4 prehospital, hospital, and interfacility data manage5 ment system that— 

6 ‘‘(A) submits data to the National EMS 

7 Information System, the National Trauma Data 

8 Bank, and others; 

9 ‘‘(B) reports data to appropriate Federal 

10 and State databanks and registries; and 

11 ‘‘(C) contains information sufficient to 

12 evaluate key elements of prehospital care, hos13 pital destination decisions, including initial hos14 pital and interfacility decisions, and relevant 

15 health outcomes of hospital care. 

16 ‘‘(d) APPLICATION.— 

17 ‘‘(1) IN GENERAL.—An eligible entity that 

18 seeks a contract or grant described in subsection (a) 

19 shall submit to the Secretary an application at such 

20 time and in such manner as the Secretary may re21 quire. 

22 ‘‘(2) APPLICATION INFORMATION.—Each appli23 cation shall include— 

24 ‘‘(A) an assurance from the eligible entity 

25 that the proposed system— 


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1 ‘‘(i) has been coordinated with the ap2 plicable State Office of Emergency Medical 

3 Services (or equivalent State office); 

4 ‘‘(ii) includes consistent indirect and 

5 direct medical oversight of prehospital, 

6 hospital, and interfacility transport 

7 throughout the region; 

8 ‘‘(iii) coordinates prehospital treat9 ment and triage, hospital destination, and 

10 interfacility transport throughout the re11 gion; 

12 ‘‘(iv) includes a categorization or des13 ignation system for special medical facili14 ties throughout the region that is inte15 grated with transport and destination pro16 tocols; 

17 ‘‘(v) includes a regional medical direc18 tion, patient tracking, and resource alloca19 tion system that supports day-to-day emer20 gency care and surge capacity and is inte21 grated with other components of the na22 tional and State emergency preparedness 

23 system; and 

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1 ness, and coordination of emergency med2 ical services for infants, children and ado3 lescents; and 

4 ‘‘(B) such other information as the Sec5 retary may require. 

6 ‘‘(e) REQUIREMENT OF MATCHING FUNDS.— 

7 ‘‘(1) IN GENERAL.—The Secretary may not 

8 make a grant under this section unless the State (or 

9 consortia of States) involved agrees, with respect to 

10 the costs to be incurred by the State (or consortia) 

11 in carrying out the purpose for which such grant 

12 was made, to make available non-Federal contribu13 tions (in cash or in kind under paragraph (2)) to14 ward such costs in an amount equal to not less than 

15 $1 for each $3 of Federal funds provided in the 

16 grant. Such contributions may be made directly or 

17 through donations from public or private entities. 

18 ‘‘(2) NON-FEDERAL CONTRIBUTIONS.—Non19 Federal contributions required in paragraph (1) may 

20 be in cash or in kind, fairly evaluated, including 

21 equipment or services (and excluding indirect or 

22 overhead costs). Amounts provided by the Federal 

23 Government, or services assisted or subsidized to 

24 any significant extent by the Federal Government, 


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1 may not be included in determining the amount of 

2 such non-Federal contributions. 

3 ‘‘(f) PRIORITY.—The Secretary shall give priority for 

4 the award of the contracts or grants described in sub5 section (a) to any eligible entity that serves a population 

6 in a medically underserved area (as defined in section 

7 330(b)(3)). 

8 ‘‘(g) REPORT.—Not later than 90 days after the com9 pletion of a pilot project under subsection (a), the recipi10 ent of such contract or grant described in shall submit 

11 to the Secretary a report containing the results of an eval12 uation of the program, including an identification of— 

13 ‘‘(1) the impact of the regional, accountable 

14 emergency care and trauma system on patient health 

15 outcomes for various critical care categories, such as 

16 trauma, stroke, cardiac emergencies, neurological 

17 emergencies, and pediatric emergencies; 

18 ‘‘(2) the system characteristics that contribute 

19 to the effectiveness and efficiency of the program (or 

20 lack thereof); 

21 ‘‘(3) methods of assuring the long-term finan22 cial sustainability of the emergency care and trauma 

23 system; 

24 ‘‘(4) the State and local legislation necessary to 

25 implement and to maintain the system; 


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1 ‘‘(5) the barriers to developing regionalized, ac2 countable emergency care and trauma systems, as 

3 well as the methods to overcome such barriers; and 

4 ‘‘(6) recommendations on the utilization of 

5 available funding for future regionalization efforts. 

6 ‘‘(h) DISSEMINATION OF FINDINGS.—The Secretary 

7 shall, as appropriate, disseminate to the public and to the 

8 appropriate Committees of the Congress, the information 

9 contained in a report made under subsection (g).’’; and 

10 (3) in section 1232— 

11 (A) in subsection (a), by striking ‘‘appro12 priated’’ and all that follows through the period 

13 at the end and inserting ‘‘appropriated 

14 $24,000,000 for each of fiscal years 2010 

15 through 2014.’’; and 

16 (B) by inserting after subsection (c) the 

17 following: 

18 ‘‘(d) AUTHORITY.—For the purpose of carrying out 

19 parts A through C, beginning on the date of enactment 

20 of the Affordable Health Choices Act, the Secretary shall 

21 transfer authority in administering grants and related au22 thorities under such parts from the Administrator of the 

23 Health Resources and Services Administration to the As24 sistant Secretary for Preparedness and Response.’’. 


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1 (b) SUPPORT FOR EMERGENCY MEDICINE RE2 SEARCH.—Part H of title IV of the Public Health Service 

3 Act (42 U.S.C. 289 et seq.) is amended by inserting after 

4 the section 498C the following: 

5 ‘‘SEC. 498D. SUPPORT FOR EMERGENCY MEDICINE RE6 SEARCH. 

7 ‘‘(a) EMERGENCY MEDICAL RESEARCH.—The Sec8 retary shall support Federal programs administered by the 

9 National Institutes of Health, the Agency for Healthcare 

10 Research and Quality, the Health Resources and Services 

11 Administration, the Centers for Disease Control and Pre12 vention, and other agencies involved in improving the 

13 emergency care system to expand and accelerate research 

14 in emergency medical care systems and emergency medi15 cine, including— 

16 ‘‘(1) the basic science of emergency medicine; 

17 ‘‘(2) the model of service delivery and the com18 ponents of such models that contribute to enhanced 

19 patient health outcomes; 

20 ‘‘(3) the translation of basic scientific research 

21 into improved practice; and 

22 ‘‘(4) the development of timely and efficient de23 livery of health services. 

24 ‘‘(b) PEDIATRIC EMERGENCY MEDICAL RE25 SEARCH.—The Secretary shall support Federal programs 


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1 administered by the National Institutes of Health, the 

2 Agency for Healthcare Research and Quality, the Health 

3 Resources and Services Administration, the Centers for 

4 Disease Control and Prevention, and other agencies to co5 ordinate and expand research in pediatric emergency med6 ical care systems and pediatric emergency medicine, in7 cluding— 

8 ‘‘(1) an examination of the gaps and opportuni9 ties in pediatric emergency care research and a 

10 strategy for the optimal organization and funding of 

11 such research; 

12 ‘‘(2) the role of pediatric emergency services as 

13 an integrated component of the overall health sys14 tem; 

15 ‘‘(3) system-wide pediatric emergency care plan16 ning, preparedness, coordination, and funding; 

17 ‘‘(4) pediatric training in professional edu18 cation; and 

19 ‘‘(5) research in pediatric emergency care, spe20 cifically on the efficacy, safety, and health outcomes 

21 of medications used for infants, children, and adoles22 cents in emergency care settings in order to improve 

23 patient safety. 

24 ‘‘(c) IMPACT RESEARCH.—The Secretary shall sup25 port research to determine the estimated economic impact 


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1 of, and savings that result from, the implementation of 

2 coordinated emergency care systems. 

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section 

5 such sums as may be necessary for each of fiscal years 

6 2010 through 2014.’’. 

7 SEC. 215. TRAUMA CARE CENTERS AND SERVICE AVAIL8 ABILITY. 

9 (a) TRAUMA CARE CENTERS.— 

10 (1) GRANTS FOR TRAUMA CARE CENTERS.— 

11 Section 1241 of the Public Health Service Act (42 

12 U.S.C. 300d–41) is amended by striking subsections 

13 (a) and (b) and inserting the following: 

14 ‘‘(a) IN GENERAL.—The Secretary shall establish 3 

15 programs to award grants to qualified public, nonprofit, 

16 Indian Health Service, Indian tribal, and urban Indian 

17 trauma centers— 

18 ‘‘(1) to assist in defraying substantial uncom19 pensated care costs; 

20 ‘‘(2) to further the core missions of such trau21 ma centers, including by addressing costs associated 

22 with patient stabilization and transfer, trauma edu23 cation and outreach, coordination with local and re24 gional trauma systems, essential personnel and other 


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1 fixed costs, and expenses associated with employee 

2 and non-employee physician services; and 

3 ‘‘(3) to provide emergency relief to ensure the 

4 continued and future availability of trauma services. 

5 ‘‘(b) MINIMUM QUALIFICATIONS OF TRAUMA CEN6 TERS.— 

7 ‘‘(1) PARTICIPATION IN TRAUMA CARE SYSTEM

8 OPERATING UNDER CERTAIN PROFESSIONAL GUIDE9 LINES.—Except as provided in paragraph (2), the 

10 Secretary may not award a grant to a trauma center 

11 under subsection (a) unless the trauma center is a 

12 participant in a trauma system that substantially 

13 complies with section 1213. 

14 ‘‘(2) EXEMPTION.—Paragraph (1) shall not 

15 apply to trauma centers that are located in States 

16 with no existing trauma care system. 

17 ‘‘(3) QUALIFICATION FOR SUBSTANTIAL UN18 COMPENSATED CARE COSTS.—The Secretary shall 

19 award substantial uncompensated care grants under 

20 subsection (a)(1) only to trauma centers meeting at 

21 least 1 of the criteria in 1 of the following 3 cat22 egories: 

23 ‘‘(A) CATEGORY A.—The criteria for cat24 egory A are as follows: 


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1 ‘‘(i) At least 40 percent of the visits 

2 in the emergency department of the hos3 pital in which the trauma center is located 

4 were charity or self-pay patients. 

5 ‘‘(ii) At least 50 percent of the visits 

6 in such emergency department were Med7 icaid (under title XIX of the Social Secu8 rity Act (42 U.S.C. 1396 et seq.)) and 

9 charity and self-pay patients combined. 

10 ‘‘(B) CATEGORY B.—The criteria for cat11 egory B are as follows: 

12 ‘‘(i) At least 35 percent of the visits 

13 in the emergency department were charity 

14 or self-pay patients. 

15 ‘‘(ii) At least 50 percent of the visits 

16 in the emergency department were Med17 icaid and charity and self-pay patients 

18 combined. 

19 ‘‘(C) CATEGORY C.—The criteria for cat20 egory C are as follows: 

21 ‘‘(i) At least 20 percent of the visits 

22 in the emergency department were charity 

23 or self-pay patients. 

24 ‘‘(ii) At least 30 percent of the visits 

25 in the emergency department were MedVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00365 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 icaid and charity and self-pay patients 

2 combined. 

3 ‘‘(4) TRAUMA CENTERS IN 1115 WAIVER

4 STATES.—Notwithstanding paragraph (3), the Sec5 retary may award a substantial uncompensated care 

6 grant to a trauma center under subsection (a)(1) if 

7 the trauma center qualifies for funds under a Low 

8 Income Pool or Safety Net Care Pool established 

9 through a waiver approved under section 1115 of the 

10 Social Security Act (42 U.S.C. 1315). 

11 ‘‘(5) DESIGNATION.—The Secretary may not 

12 award a grant to a trauma center unless such trau13 ma center is verified by the American College of 

14 Surgeons or designated by an equivalent State or 

15 local agency. 

16 ‘‘(c) ADDITIONAL REQUIREMENTS.—The Secretary 

17 may not award a grant to a trauma center under sub18 section (a)(1) unless such trauma center— 

19 ‘‘(1) submits to the Secretary a plan satisfac20 tory to the Secretary that demonstrates a continued 

21 commitment to serving trauma patients regardless of 

22 their ability to pay; and 

23 ‘‘(2) has policies in place to assist patients who 

24 cannot pay for part or all of the care they receive, 


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1 including a sliding fee scale, and to ensure fair bill2 ing and collection practices.’’. 

3 (2) CONSIDERATIONS IN MAKING GRANTS.— 

4 Section 1242 of the Public Health Service Act (42 

5 U.S.C. 300d–42) is amended by striking subsections 

6 (a) and (b) and inserting the following: 

7 ‘‘(a) SUBSTANTIAL UNCOMPENSATED CARE

8 AWARDS.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall estab10 lish an award basis for each eligible trauma center 

11 for grants under section 1241(a)(1) according to the 

12 percentage described in paragraph (2), subject to the 

13 requirements of section 1241(b)(3). 

14 ‘‘(2) PERCENTAGES.—The applicable percent15 ages are as follows: 

16 ‘‘(A) With respect to a category A trauma 

17 center, 100 percent of the uncompensated care 

18 costs. 

19 ‘‘(B) With respect to a category B trauma 

20 center, not more than 75 percent of the uncom21 pensated care costs. 

22 ‘‘(C) With respect to a category C trauma 

23 center, not more than 50 percent of the uncom24 pensated care costs. 

25 ‘‘(b) CORE MISSION AWARDS.— 


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1 ‘‘(1) IN GENERAL.—In awarding grants under 

2 section 1241(a)(2), the Secretary shall— 

3 ‘‘(A) reserve 25 percent of the amount al4 located for core mission awards for Level III 

5 and Level IV trauma centers; and 

6 ‘‘(B) reserve 25 percent of the amount al7 located for core mission awards for large urban 

8 Level I and II trauma centers— 

9 ‘‘(i) that have at least 1 graduate 

10 medical education fellowship in trauma or 

11 trauma related specialties for which de12 mand is exceeding supply; 

13 ‘‘(ii) for which— 

14 ‘‘(I) annual uncompensated care 

15 costs exceed $10,000,000; or 

16 ‘‘(II) at least 20 percent of emer17 gency department visits are charity or 

18 self-pay or Medicaid patients; and 

19 ‘‘(iii) that are not eligible for substan20 tial uncompensated care awards under sec21 tion 1241(a)(1). 

22 ‘‘(c) EMERGENCY AWARDS.—In awarding grants 

23 under section 1241(a)(3), the Secretary shall— 

24 ‘‘(1) give preference to any application sub25 mitted by a trauma center that provides trauma care 


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1 in a geographic area in which the availability of 

2 trauma care has significantly decreased or will sig3 nificantly decrease if the center is forced to close or 

4 downgrade service or growth in demand for trauma 

5 services exceeds capacity; and 

6 ‘‘(2) reallocate any emergency awards funds not 

7 obligated due to insufficient, or a lack of qualified, 

8 applications to the significant uncompensated care 

9 award program.’’. 

10 (3) CERTAIN AGREEMENTS.—Section 1243 of 

11 the Public Health Service Act (42 U.S.C. 300d–43) 

12 is amended by striking subsections (a), (b), and (c) 

13 and inserting the following: 

14 ‘‘(a) MAINTENANCE OF FINANCIAL SUPPORT.—The 

15 Secretary may require a trauma center receiving a grant 

16 under section 1241(a) to maintain access to trauma serv17 ices at comparable levels to the prior year during the grant 

18 period . 

19 ‘‘(b) TRAUMA CARE REGISTRY.—The Secretary may 

20 require the trauma center receiving a grant under section 

21 1241(a) to provide data to a national and centralized reg22 istry of trauma cases, in accordance with guidelines devel23 oped by the American College of Surgeons, and as the Sec24 retary may otherwise require.’’. 


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1 (4) GENERAL PROVISIONS.—Section 1244 of 

2 the Public Health Service Act (42 U.S.C. 300d–44) 

3 is amended by striking subsections (a), (b), and (c) 

4 and inserting the following: 

5 ‘‘(a) APPLICATION.—The Secretary may not award 

6 a grant to a trauma center under section 1241(a) unless 

7 such center submits an application for the grant to the 

8 Secretary and the application is in such form, is made in 

9 such manner, and contains such agreements, assurances, 

10 and information as the Secretary determines to be nec11 essary to carry out this part. 

12 ‘‘(b) LIMITATION ON DURATION OF SUPPORT.—The 

13 period during which a trauma center receives payments 

14 under a grant under section 1241(a)(3) shall be for 3 fis15 cal years, except that the Secretary may waive such re16 quirement for a center and authorize such center to re17 ceive such payments for 1 additional fiscal year. 

18 ‘‘(c) LIMITATION ON AMOUNT OF GRANT.—Notwith19 standing section 1242(a), a grant under section 1241 may 

20 not be made in an amount exceeding $2,000,000 for each 

21 fiscal year. 

22 ‘‘(d) ELIGIBILITY.—Except as provided in section 

23 1242(b)(1)(B)(iii), acquisition of, or eligibility for, a grant 

24 under section 1241(a) shall not preclude a trauma center 


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1 from being eligible for other grants described in such sec2 tion. 

3 ‘‘(e) FUNDING DISTRIBUTION.—Of the total amount 

4 appropriated for a fiscal year under section 1245, 70 per5 cent shall be used for substantial uncompensated care 

6 awards under section 1241(a)(1), 20 percent shall be used 

7 for core mission awards under section 1241(a)(2), and 10 

8 percent shall be used for emergency awards under section 

9 1241(a)(3). 

10 ‘‘(f) MINIMUM ALLOWANCE.—Notwithstanding sub11 section (e), if the amount appropriated for a fiscal year 

12 under section 1245 is less than $25,000,000, all available 

13 funding for such fiscal year shall be used for substantial 

14 uncompensated care awards under section 1241(a)(1). 

15 ‘‘(g) SUBSTANTIAL UNCOMPENSATED CARE AWARD

16 DISTRIBUTION AND PROPORTIONAL SHARE.—Notwith17 standing section 1242(a), of the amount appropriated for 

18 substantial uncompensated care grants for a fiscal year, 

19 the Secretary shall— 

20 ‘‘(1) make available— 

21 ‘‘(A) 50 percent of such funds for category 

22 A trauma center grantees; 

23 ‘‘(B) 35 percent of such funds for category 

24 B trauma center grantees; and 


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1 ‘‘(C) 15 percent of such funds for category 

2 C trauma center grantees; and 

3 ‘‘(2) provide available funds within each cat4 egory in a manner proportional to the award basis 

5 specified in section 1242(a)(2) to each eligible trau6 ma center. 

7 ‘‘(h) REPORT.—Beginning 2 years after the date of 

8 enactment of the Affordable Health Choices Act, and 

9 every 2 years thereafter, the Secretary shall biennially re10 port to Congress regarding the status of the grants made 

11 under section 1241 and on the overall financial stability 

12 of trauma centers.’’. 

13 (5) AUTHORIZATION OF APPROPRIATIONS.— 

14 Section 1245 of the Public Health Service Act (42 

15 U.S.C. 300d–45) is amended to read as follows: 

16 ‘‘SEC. 1245. AUTHORIZATION OF APPROPRIATIONS. 

17 ‘‘For the purpose of carrying out this part, there are 

18 authorized to be appropriated $100,000,000 for fiscal year 

19 2009, and such sums as may be necessary for each of fis20 cal years 2010 through 2015. Such authorization of ap21 propriations is in addition to any other authorization of 

22 appropriations or amounts that are available for such pur23 pose.’’. 


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1 (6) DEFINITION.—Part D of title XII of the 

2 Public Health Service Act (42 U.S.C. 300d–41 et 

3 seq.) is amended by adding at the end the following: 

4 ‘‘SEC. 1246. DEFINITION. 

5 ‘‘In this part, the term ‘uncompensated care costs’ 

6 means unreimbursed costs from serving self-pay, charity, 

7 or Medicaid patients, without regard to payment under 

8 section 1923 of the Social Security Act, all of which are 

9 attributable to emergency care and trauma care, including 

10 costs related to subsequent inpatient admissions to the 

11 hospital.’’. 

12 (b) TRAUMA SERVICE AVAILABILITY.—Title XII of 

13 the Public Health Service Act (42 U.S.C. 300d et seq.) 

14 is amended by adding at the end the following: 

15 ‘‘PART H—TRAUMA SERVICE AVAILABILITY 

16 ‘‘SEC. 1281. GRANTS TO STATES. 

17 ‘‘(a) ESTABLISHMENT.—To promote universal access 

18 to trauma care services provided by trauma centers and 

19 trauma-related physician specialties, the Secretary shall 

20 provide funding to States to enable such States to award 

21 grants to eligible entities for the purposes described in this 

22 section. 

23 ‘‘(b) AWARDING OF GRANTS BY STATES.—Each 

24 State may award grants to eligible entities within the 

25 State for the purposes described in subparagraph (d). 


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1 ‘‘(c) ELIGIBILITY.— 

2 ‘‘(1) IN GENERAL.—To be eligible to receive a 

3 grant under subsection (b) an entity shall— 

4 ‘‘(A) be— 

5 ‘‘(i) a public or nonprofit trauma cen6 ter or consortium thereof that meets that 

7 requirements of paragraphs (1), (2), and 

8 (5) of section 1241(b); 

9 ‘‘(ii) a safety net public or nonprofit 

10 trauma center that meets the requirements 

11 of paragraphs (1) through (5) of section 

12 1241(b); or 

13 ‘‘(iii) a hospital in an underserved 

14 area (as defined by the State) that seeks 

15 to establish new trauma services; and 

16 ‘‘(B) submit to the State an application at 

17 such time, in such manner, and containing such 

18 information as the State may require. 

19 ‘‘(2) LIMITATION.—A State shall use at least 

20 40 percent of the amount available to the State 

21 under this part for a fiscal year to award grants to 

22 safety net trauma centers described in paragraph 

23 (1)(A)(ii). 


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1 ‘‘(d) USE OF FUNDS.—The recipient of a grant under 

2 subsection (b) shall carry out 1 or more of the following 

3 activities consistent with subsection (b): 

4 ‘‘(1) Providing trauma centers with funding to 

5 support physician compensation in trauma-related 

6 physician specialties where shortages exist in the re7 gion involved, with priority provided to safety net 

8 trauma centers described in subsection (c)(1)(A)(ii). 

9 ‘‘(2) Providing for individual safety net trauma 

10 center fiscal stability and costs related to having 

11 service that is available 24 hours a day, 7 days a 

12 week, with priority provided to safety net trauma 

13 centers described in subsection (c)(1)(A)(ii) located 

14 in urban, border, and rural areas. 

15 ‘‘(3) Reducing trauma center overcrowding at 

16 specific trauma centers related to throughput of 

17 trauma patients. 

18 ‘‘(4) Establishing new trauma services in un19 derserved areas as defined by the State. 

20 ‘‘(5) Enhancing collaboration between trauma 

21 centers and other hospitals and emergency medical 

22 services personnel related to trauma service avail23 ability. 


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1 ‘‘(6) Making capital improvements to enhance 

2 access and expedite trauma care, including providing 

3 helipads and associated safety infrastructure. 

4 ‘‘(7) Enhancing trauma surge capacity at spe5 cific trauma centers. 

6 ‘‘(8) Ensuring expedient receipt of trauma pa7 tients transported by ground or air to the appro8 priate trauma center. 

9 ‘‘(9) Enhancing interstate trauma center col10 laboration. 

11 ‘‘(e) LIMITATION.— 

12 ‘‘(1) IN GENERAL.—A State may use not more 

13 than 20 percent of the amount available to the State 

14 under this part for a fiscal year for administrative 

15 costs associated with awarding grants and related 

16 costs. 

17 ‘‘(2) MAINTENANCE OF EFFORT.—The Sec18 retary may not provide funding to a State under this 

19 part unless the State agrees that such funds will be 

20 used to supplement and not supplant State funding 

21 otherwise available for the activities and costs de22 scribed in this part. 

23 ‘‘(f) DISTRIBUTION OF FUNDS.—The following shall 

24 apply with respect to grants provided in this part: 


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1 ‘‘(1) LESS THAN $10,000,000.—If the amount of 

2 appropriations for this part in a fiscal year is less 

3 than $10,000,000, the Secretary shall divide such 

4 funding evenly among only those States that have 1 

5 or more trauma centers eligible for funding under 

6 section 1241(b)(3)(A). 

7 ‘‘(2) LESS THAN $20,000,000.—If the amount of 

8 appropriations in a fiscal year is less than 

9 $20,000,000, the Secretary shall divide such funding 

10 evenly among only those States that have 1 or more 

11 trauma centers eligible for funding under subpara12 graphs (A) and (B) of section 1241(b)(3). 

13 ‘‘(3) LESS THAN $30,000,000.—If the amount of 

14 appropriations for this part in a fiscal year is less 

15 than $30,000,000, the Secretary shall divide such 

16 funding evenly among only those States that have 1 

17 or more trauma centers eligible for funding under 

18 section 1241(b)(3). 

19 ‘‘(4) $30,000,000 OR MORE.—If the amount of 

20 appropriations for this part in a fiscal year is 

21 $30,000,000 or more, the Secretary shall divide such 

22 funding evenly among all States. 


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1 ‘‘SEC. 1282. AUTHORIZATION OF APPROPRIATIONS. 

2 ‘‘For the purpose of carrying out this part, there is 

3 authorized to be appropriated $100,000,000 for each of 

4 fiscal years 2010 through 2015.’’. 

5 SEC. 216. REDUCING AND REPORTING HOSPITAL READMIS6 SIONS. 

7 (a) IN GENERAL.—Part S of title III of the Public 

8 Health Service Act, as amended by section 205, is further 

9 amended by adding at the end the following: 

10 ‘‘SEC. 399NN. READMISSIONS. 

11 ‘‘(a) PURPOSE.—The purpose of this section is to im12 prove the quality and value of inpatient hospital services 

13 in order to— 

14 ‘‘(1) improve the coordination of care; and 

15 ‘‘(2) appropriately reduce inefficiency and 

16 waste, such as unnecessary hospital readmissions, in 

17 the care furnished. 

18 ‘‘(b) INFORMATION GATHERING AND ANALYSIS.— 

19 Beginning 2010, the Secretary shall analyze and calculate 

20 hospital-specific and national applicable readmissions 

21 rates based on subsection (e). In developing criteria and 

22 carrying out this section, the Secretary shall consider the 

23 unique characters of rural and low-volume hospitals (in24 cluding critical access hospitals). 

25 ‘‘(c) DISCLOSURE.— 


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1 ‘‘(1) IN GENERAL.—Beginning in 2011, the 

2 Secretary shall establish procedures to provide for 

3 the confidential disclosure to hospitals receiving 

4 funds under this Act of information on hospital-spe5 cific and national applicable readmission rates de6 scribed in subsection (b). 

7 ‘‘(2) PUBLIC DISCLOSURE OF INFORMATION.— 

8 Not later than 2 years after the date of enactment 

9 of this section, the Secretary shall make the infor10 mation on the rates of applicable readmission rates 

11 and other statistical information of hospital receiving 

12 funds under this Act disclosed under paragraph (1) 

13 publicly available in a form and manner determined 

14 appropriate by the Secretary. 

15 ‘‘(3) REPORT.—Not later than 180 days after 

16 the date of enactment of this section, the Secretary 

17 shall submit to Congress a report that contains— 

18 ‘‘(A) a summary of the implementation of 

19 the procedures under paragraph (1); 

20 ‘‘(B) a plan for the public disclosure of in21 formation under paragraph (2); and 

22 ‘‘(C) recommendations for such legislation 

23 or administrative action as the Secretary deter24 mines appropriate. 

25 ‘‘(d) APPLICABLE READMISSION DEFINED.— 


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1 ‘‘(1) IN GENERAL.—In this section, the term 

2 ‘applicable readmission’ means a readmission— 

3 ‘‘(A) selected by the Secretary under sub4 section (e)); 

5 ‘‘(B) that occurs within a time interval (as 

6 specified under subsection (f)) following a dis7 charge from a hospital; and 

8 ‘‘(C) which is for a condition or procedure 

9 selected under subsection (g). 

10 ‘‘(2) DETERMINATION OF APPLICABILITY TO

11 READMISSIONS TO CERTAIN HOSPITALS.—The Sec12 retary shall determine whether the term ‘applicable 

13 readmission’ includes readmissions to the same hos14 pital as the prior discharge or readmissions to any 

15 hospital. 

16 ‘‘(e) SELECTION OF READMISSIONS.—Not later 6 

17 months after the date of enactment of this section, the 

18 Secretary, in consultation with appropriate representatives 

19 of the Centers for Medicare & Medicaid Services and the 

20 Agency for Healthcare Research and Quality, shall, for 

21 each of the conditions or procedures selected under sub22 section (g), select readmissions that meet each of the fol23 lowing requirements: 

24 ‘‘(1) The readmission could reasonably have 

25 been prevented by the provision of care consistent 


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1 with evidence-based guidelines during the prior ad2 mission or the post discharge follow-up period. 

3 ‘‘(2) The readmission is for a condition or pro4 cedure related to the care provided during the prior 

5 admission or post discharge follow-up period, which 

6 includes a readmission for the following: 

7 ‘‘(A) The same condition or procedure as 

8 the prior discharge. 

9 ‘‘(B) An infection or other complication of 

10 care. 

11 ‘‘(C) A condition or procedure indicative of 

12 a failed surgical intervention. 

13 ‘‘(D) Other conditions or procedures as de14 termined appropriate by the Secretary. 

15 ‘‘(f) SPECIFICATION OF TIME INTERVAL.—The Sec16 retary shall specify a time interval, of not less than 7 days 

17 and not more than 30 days, between the prior discharge 

18 and applicable readmission for purposes of this section. 

19 ‘‘(g) SELECTION OF CONDITIONS OR PROCE20 DURES.— 

21 ‘‘(1) IN GENERAL.—Not later than 6 months 

22 after the date of enactment of this section, the Sec23 retary shall select at least 2 conditions or procedures 

24 which meet each of the following requirements: 


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1 ‘‘(A) Such conditions or procedures have a 

2 high volume. 

3 ‘‘(B) For the time interval specified under 

4 subsection (f), such conditions or procedures 

5 have a relatively high rate of occurrence of sub6 sequent readmissions described in subsection 

7 (f), as compared to all other conditions or pro8 cedures. 

9 ‘‘(2) EXPANSION OF CONDITIONS OR PROCE10 DURES SELECTED.—The Secretary shall expand the 

11 list of readmission conditions analyzed under this 

12 section to include at least 8 conditions with the 

13 highest volume and highest rate of readmissions. At 

14 least one of the conditions selected shall be a condi15 tion prevalent in geriatric patients. 

16 ‘‘(h) QUALITY IMPROVEMENT PROGRAM FOR HOS17 PITALS WITH A HIGH SEVERITY ADJUSTED READMISSION

18 RATE.— 

19 ‘‘(1) ESTABLISHMENT.— 

20 ‘‘(A) IN GENERAL.—Not later than 2 years 

21 after the date of enactment of this section, the 

22 Secretary shall establish a program for eligible 

23 hospitals to improve their readmission rates 

24 through the use of patient safety organizations 

25 (as defined in section 921(4)). 


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1 ‘‘(B) ELIGIBLE HOSPITAL DEFINED.—In 

2 this subsection, the term ‘eligible hospital’ 

3 means a hospital which the Secretary deter4 mines (based on the most recent available his5 torical data) has a severity adjusted readmis6 sion rate for the conditions described in sub7 section (g) among the highest 25 percent of all 

8 hospitals nationally. 

9 ‘‘(C) RISK ADJUSTMENT.—The Secretary 

10 shall utilize appropriate risk adjustment meas11 ures to determine eligible hospitals. 

12 ‘‘(2) REPORT TO THE SECRETARY.—Eligible 

13 hospitals and patient safety organizations working 

14 with those hospitals shall report to the Secretary on 

15 the processes employed by the hospital to improve 

16 readmission rates and the impact of such processes 

17 on readmission rates.’’. 

18 (b) GAO STUDY AND REPORT.— 

19 (1) STUDY.—The Comptroller General of the 

20 United States shall conduct a study on the impact 

21 of section 399NN of the Public Health Service Act, 

22 as added by subsection (a), on— 

23 (A) care furnished to consumers; 

24 (B) expenditures under Federal health pro25 grams; and 


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1 (C) the cost and quality of care furnished 

2 by hospitals. 

3 (2) REPORT.—Not later than January 1, 2013, 

4 the Comptroller General of the United States shall 

5 submit to Congress a report on the study conducted 

6 under paragraph (1), together with recommenda7 tions for such legislation and administrative action 

8 as the Comptroller General determines appropriate. 

9 (c) STUDY BY IOM.— 

10 (1) IN GENERAL.—The Secretary of Health and 

11 Human Services shall seek to enter into an agree12 ment with the Institute of Medicine to submit to 

13 Congress, not later than 1 year after the date of en14 actment of this Act, a report on recommendations on 

15 how to reduce unnecessary hospital readmissions. 

16 Such report shall also include recommendations on 

17 how to develop a coordinated care plan for patients 

18 being discharged from the hospital. 

19 (2) AUTHORIZATION.—For the purpose of car20 rying out this subsection, there is authorized to be 

21 appropriated such sums as may be necessary for fis22 cal year 2010. 


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1 SEC. 217. PROGRAM TO FACILITATE SHARED DECISION2 MAKING. 

3 Part D of title IX of the Public Health Service Act, 

4 as amended by section 213, is further amended by adding 

5 at the end the following: 

6 ‘‘SEC. 936. PROGRAM TO FACILITATE SHARED DECISION7 MAKING. 

8 ‘‘(a) PURPOSE.—The purpose of this section is to fa9 cilitate collaborative processes between patients, caregivers 

10 or authorized representatives, and clinicians that engages 

11 the patient, caregiver or authorized representative in deci12 sionmaking, provides patients, caregivers or authorized 

13 representatives with information about trade-offs among 

14 treatment options, and facilitates the incorporation of pa15 tient preferences and values into the medical plan. 

16 ‘‘(b) DEFINITIONS.—In this section: 

17 ‘‘(1) PATIENT DECISION AID.—The term ‘pa18 tient decision aid’ means an educational tool that 

19 helps patients, caregivers or authorized representa20 tives understand and communicate their beliefs and 

21 preferences related to their treatment options, and 

22 to decide with their health care provider what treat23 ments are best for them based on their treatment 

24 options, scientific evidence, circumstances, beliefs, 

25 and preferences. 


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1 ‘‘(2) PREFERENCE SENSITIVE CARE.—The term 

2 ‘preference sensitive care’ means medical care for 

3 which the clinical evidence does not clearly support 

4 one treatment option such that the appropriate 

5 course of treatment depends on the values of the pa6 tient or the preferences of the patient, caregivers or 

7 authorized representatives regarding the benefits, 

8 harms and scientific evidence for each treatment op9 tion, the use of such care should depend on the in10 formed patient choice among clinically appropriate 

11 treatment options. 

12 ‘‘(c) ESTABLISHMENT OF INDEPENDENT STANDARDS

13 FOR PATIENT DECISION AIDS FOR PREFERENCE SEN14 SITIVE CARE.— 

15 ‘‘(1) CONTRACT WITH ENTITY TO ESTABLISH

16 STANDARDS AND CERTIFY PATIENT DECISION

17 AIDS.— 

18 ‘‘(A) IN GENERAL.—For purposes of sup19 porting consensus-based standards for patient 

20 decision aids for preference sensitive care and a 

21 certification process for patient decision aids for 

22 use in the Federal health programs and by 

23 other interested parties, the Secretary shall 

24 have in effect a contract with the qualified con25 sensus-based entity identified in section 399JJ. 


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1 Such contract shall provide that the entity per2 form the duties described in paragraph (2). 

3 ‘‘(B) TIMING FOR FIRST CONTRACT.—As 

4 soon as practicable after the date of the enact5 ment of this section, the Secretary shall enter 

6 into the first contract under subparagraph (A). 

7 ‘‘(C) PERIOD OF CONTRACT.—A contract 

8 under subparagraph (A) shall be for a period of 

9 18 months (except such contract may be re10 newed after a subsequent bidding process). 

11 ‘‘(2) DUTIES.—The following duties are de12 scribed in this paragraph: 

13 ‘‘(A) DEVELOP AND IDENTIFY STANDARDS

14 FOR PATIENT DECISION AIDS.—The entity shall 

15 synthesize evidence and convene a broad range 

16 of experts and key stakeholders to develop and 

17 identify consensus-based standards to evaluate 

18 patient decision aids for preference sensitive 

19 care. 

20 ‘‘(B) ENDORSE PATIENT DECISION AIDS.— 

21 The entity shall review patient decision aids 

22 and develop a certification process whether pa23 tient decision aids meet the standards developed 

24 and identified under subparagraph (A). The en25 tity shall give priority to the review and certifiVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00387 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 cation of patient decision aids for preference 

2 sensitive care. 

3 ‘‘(d) PROGRAM TO DEVELOP, UPDATE AND PATIENT

4 DECISION AIDS TO ASSIST HEALTH CARE PROVIDERS

5 AND PATIENTS.— 

6 ‘‘(1) IN GENERAL.—The Secretary, acting 

7 through the Director, and in coordination with heads 

8 of other relevant agencies, such as the Director of 

9 the Centers for Disease Control and Prevention and 

10 the Director of the National Institutes of Health, 

11 shall establish a program to award grants or con12 tracts— 

13 ‘‘(A) to develop, update, and produce pa14 tient decision aids for preference sensitive care 

15 to assist health care providers in educating pa16 tients, caregivers, and authorized representa17 tives concerning the relative safety, relative ef18 fectiveness (including possible health outcomes 

19 and impact on functional status), and relative 

20 cost of treatment or, where appropriate, pallia21 tive care options; 

22 ‘‘(B) to test such materials to ensure such 

23 materials are balanced and evidence based in 

24 aiding health care providers and patients, care25 givers, and authorized representatives to make 


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1 informed decisions about patient care and can 

2 be easily incorporated into a broad array of 

3 practice settings; and 

4 ‘‘(C) to educate providers on the use of 

5 such materials, including through academic cur6 ricula. 

7 ‘‘(2) REQUIREMENTS FOR PATIENT DECISION

8 AIDS.—Patient decision aids developed and produced 

9 pursuant to a grant or contract under paragraph 

10 (1)— 

11 ‘‘(A) shall be designed to engage patients, 

12 caregivers, and authorized representatives in in13 formed decisionmaking with health care pro14 viders; 

15 ‘‘(B) shall present up-to-date clinical evi16 dence about the risks and benefits of treatment 

17 options in a form and manner that is age-ap18 propriate and can be adapted for patients, care19 givers, and authorized representatives from a 

20 variety of cultural and educational backgrounds 

21 to reflect the varying needs of consumers and 

22 diverse levels of health literacy; 

23 ‘‘(C) shall, where appropriate, explain why 

24 there is a lack of evidence to support one treat25 ment option over another; and 


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1 ‘‘(D) shall address health care decisions 

2 across the age span, including those affecting 

3 vulnerable populations including children. 

4 ‘‘(3) DISTRIBUTION.—The Director shall ensure 

5 that patient decision aids produced with grants or 

6 contracts under this section are available to the pub7 lic. 

8 ‘‘(4) NONDUPLICATION OF EFFORTS.—The Di9 rector shall ensure that the activities under this sec10 tion of the Agency and other agencies, including the 

11 Centers for Disease Control and Prevention and the 

12 National Institutes of Health, are free of unneces13 sary duplication of effort. 

14 ‘‘(e) GRANTS TO SUPPORT SHARED DECISION MAK15 ING IMPLEMENTATION.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall estab17 lish a program to provide for the phased-in develop18 ment, implementation, and evaluation of shared deci19 sionmaking using patient decision aids to meet the 

20 objective of improving the understanding of patients 

21 of their medical treatment options. 

22 ‘‘(2) SHARED DECISIONMAKING RESOURCE CEN23 TERS.— 

24 ‘‘(A) IN GENERAL.—The Secretary shall 

25 provide grants for the establishment and supVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00390 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 port of Shared Decision Making Resource Cen2 ters (referred to in this subsection as ‘Centers’) 

3 to provide technical assistance to providers and 

4 to develop and disseminate best practices and 

5 other information to support and accelerate 

6 adoption, implementation, and effective use of 

7 patient decision aids and shared decision mak8 ing by providers. 

9 ‘‘(B) OBJECTIVES.—The objective of a 

10 Center is to enhance and promote the adoption 

11 of patient decision aids and shared decision12 making through— 

13 ‘‘(i) providing assistance to eligible 

14 providers with the implementation and ef15 fective use of, and training on, patient de16 cision aids; and 

17 ‘‘(ii) the dissemination of best prac18 tices and research on the implementation 

19 and effective use of patient decision aids. 

20 ‘‘(3) SHARED DECISIONMAKING PARTICIPATION

21 GRANTS.— 

22 ‘‘(A) IN GENERAL.—The Secretary shall 

23 provide grants to health care providers for the 

24 development and implementation of shared deci25 sionmaking techniques. 


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1 ‘‘(B) PREFERENCE.—In order to facilitate 

2 the use of best practices, the Secretary shall 

3 provide a preference in making grants under 

4 this subsection to health care providers who 

5 participate in training by Shared Decision Mak6 ing Resource Centers or comparable training. 

7 ‘‘(C) LIMITATION.—Funds under this 

8 paragraph shall not be used to purchase or im9 plement use of patient decision aids other than 

10 those certified under the process identified in 

11 subsection (c). 

12 ‘‘(4) GUIDANCE.—The Secretary may issue 

13 guidance to eligible grantees under this subsection 

14 on the use of patient decision aids. 

15 ‘‘(5) QUALITY MEASURES.— 

16 ‘‘(A) IN GENERAL.—The Secretary shall 

17 measure the quality of shared decisionmaking. 

18 For purposes of making such measurements, 

19 the Secretary shall select quality measures as 

20 described in section 399JJ. 

21 ‘‘(B) REPORTING DATA ON MEASURES.—A 

22 provider receiving a grant under this subsection 

23 shall report to the Secretary data on quality 

24 measures selected under subparagraph (A) in 


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1 accordance with procedures established by the 

2 Secretary. 

3 ‘‘(C) FEEDBACK ON MEASURES.—The Sec4 retary shall provide confidential reports to eligi5 ble providers receiving a grant under this sec6 tion on the performance of the eligible provider 

7 on quality measures selected by the Secretary 

8 under subparagraph (A), the aggregate per9 formance of all eligible providers participating 

10 in the program, and any improvements in such 

11 performance. Such reports shall be made pub12 licly available not less than 3 years after the 

13 date of enactment of this section. 

14 ‘‘(D) GRANT TO FUND DEVELOPMENT OF

15 PERFORMANCE MEASURES.—The Director may, 

16 through the quality measure development pro17 gram under section 931, award grants or con18 tracts to eligible entities to fund development of 

19 performance measures which assess the use by 

20 health care providers of shared decisionmaking 

21 processes or patient decision aids. 

22 ‘‘(E) CONTENTS OF REPORT.—Each report 

23 submitted under this paragraph shall— 

24 ‘‘(i) include an assessment of— 


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1 ‘‘(I) quality measures selected 

2 under subparagraph (A); 

3 ‘‘(II) patient and health care pro4 vider satisfaction with regard to ac5 tivities carried out under this para6 graph; 

7 ‘‘(III) utilization of medical serv8 ices for patients of providers receiving 

9 a grant under this paragraph and 

10 other patients as determined appro11 priate by the Secretary; 

12 ‘‘(IV) appropriate utilization of 

13 shared decisionmaking by providers 

14 receiving a grant under this para15 graph; and 

16 ‘‘(V) the costs to providers par17 ticipating of selecting, purchasing, 

18 and incorporating approved patient 

19 decision aids and meeting reporting 

20 requirements under this paragraph; 

21 and 

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1 making under the applicable phase of the 

2 program. 

3 ‘‘(f) FUNDING.—For purposes of carrying out this 

4 section there are authorized to be appropriated such sums 

5 as may be necessary for fiscal year 2010 and each subse6 quent fiscal year.’’. 

7 SEC. 218. PRESENTATION OF PRESCRIPTION DRUG BEN8 EFIT AND RISK INFORMATION. 

9 (a) IN GENERAL.—The Secretary of Health and 

10 Human Services (referred to in this section as the ‘‘Sec11 retary’’), acting through the Commissioner of Food and 

12 Drugs, shall determine whether the addition of quan13 titative summaries of the benefits and risks of prescription 

14 drugs in a standardized format (such as a table or drug 

15 facts box) to the promotional labeling or print advertising 

16 of such drugs would improve health care decisionmaking 

17 by clinicians and patients and consumers. 

18 (b) REVIEW AND CONSULTATION.—In making the 

19 determination under subsection (a), the Secretary shall re20 view all available scientific evidence and research on deci21 sionmaking and social and cognitive psychology and con22 sult with drug manufacturers, clinicians, patients and con23 sumers, experts in health literacy, representatives of racial 

24 and ethnic minorities, and experts in women’s and pedi25 atric health. 


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1 (c) REPORT.—Not later than 1 year after the date 

2 of enactment of this Act, the Secretary shall submit to 

3 Congress a report that provides— 

4 (1) the determination by the Secretary under 

5 subsection (a); and 

6 (2) the reasoning and analysis underlying that 

7 determination. 

8 (d) AUTHORITY.—If the Secretary determines under 

9 subsection (a) that the addition of quantitative summaries 

10 of the benefits and risks of prescription drugs in a stand11 ardized format (such as a table or drug facts box) to the 

12 promotional labeling or print advertising of such drugs 

13 would improve health care decision-making by clinicians 

14 and patients and consumers, then the Secretary, not later 

15 than 3 years after the date of submission of the report 

16 under subsection (c), shall promulgate proposed regula17 tions as necessary to implement such format. 

18 (e) CLARIFICATION.—Nothing in this section shall be 

19 construed to restrict the existing authorities of the Sec20 retary with respect to benefit and risk information. 

21 SEC. 219. CENTER FOR HEALTH OUTCOMES RESEARCH AND 

22 EVALUATION. 

23 Part D of title IX of the Public Health Service Act, 

24 as amended by section 217, is further amended by adding 

25 at the end the following: 


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1 ‘‘SEC. 937. CENTER FOR HEALTH OUTCOMES RESEARCH 

2 AND EVALUATION. 

3 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab4 lish within the Agency the Center for Health Outcomes 

5 Research and Evaluation (referred to in this section as 

6 the ‘Center’) to collect, conduct, support, and synthesize 

7 research with respect to comparing health outcomes, effec8 tiveness, and appropriateness of health care services and 

9 procedures in order to identify the manner in which dis10 eases, disorders, and other health conditions can most ef11 fectively and appropriately be prevented, diagnosed, treat12 ed, and managed clinically. 

13 ‘‘(b) DUTIES.—The Center shall— 

14 ‘‘(1) coordinate, conduct, support, and syn15 thesize research relevant to the comparative health 

16 outcomes and effectiveness of the full spectrum of 

17 health care treatments, including pharmaceuticals, 

18 medical devices, medical and surgical procedures, 

19 screening and diagnostics, behavioral health care, 

20 oral health, and other health interventions; 

21 ‘‘(2) coordinate, conduct, and support system22 atic reviews of clinical research, including original 

23 research conducted subsequent to the date of the en24 actment of this section; 

25 ‘‘(3) coordinate, conduct, support, and syn26 thesize research that— 


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1 ‘‘(A) identifies which treatment is most ef2 fective and least toxic for each individual given 

3 each individual’s genetic makeup and coexisting 

4 conditions; and 

5 ‘‘(B) reduces treatment disparities, among 

6 ethnic and racial minorities, children, and vul7 nerable populations; 

8 ‘‘(4) use a broad range of methodologies, in9 cluding randomized controlled clinical trials, observa10 tional studies and other approaches; 

11 ‘‘(5) create informational tools that organize, 

12 synthesize, and disseminate research findings to pro13 viders, patients, and public and private payers; 

14 ‘‘(6) develop a publicly available resource data15 base that collects and contains high-quality, inde16 pendent evidence to inform healthcare decision17 making, which shall include reliable evidence from 

18 government and non-government sources; 

19 ‘‘(7) submit to the Secretary, and Congress ap20 propriate relevant reports described in subsection 

21 (h); 

22 ‘‘(8) encourage, as appropriate, the development 

23 and use of clinical registries and the development of 

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1 ical device surveillance efforts, and other forms of 

2 electronic health data; and 

3 ‘‘(9) not later than one year after the date of 

4 the enactment of this section, develop minimum 

5 methodological standards to be used when con6 ducting studies of comparative health outcomes and 

7 value (and procedures for use of such standards) in 

8 order to help ensure accurate and effective compari9 sons and assessments of treatment options, and up10 date such standards at least biennially. 

11 ‘‘(c) POWERS.— 

12 ‘‘(1) OBTAINING OFFICIAL DATA.—The Center 

13 may secure directly from any department or agency 

14 of the United States information necessary to enable 

15 the Center to carry out this section. Upon request 

16 of the Center, the head of that department or agen17 cy shall furnish that information to the Center on an 

18 agreed upon schedule. 

19 ‘‘(2) DATA COLLECTION.—In order to carry out 

20 its functions, the Center shall— 

21 ‘‘(A) utilize existing information, both pub22 lished and unpublished, where possible, collected 

23 and assessed either by the staff of the Center 

24 or under other arrangements made in accord25 ance with this section; 


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1 ‘‘(B) carry out, or award grants or con2 tracts for, original research and experimen3 tation, where existing information is inad4 equate; 

5 ‘‘(C) adopt procedures allowing any inter6 ested party to submit information for use by 

7 the Center or the Advisory Counsel under sub8 section (d) in making reports and recommenda9 tions; and 

10 ‘‘(D) comply with any existing data privacy 

11 standards applicable to the Center. 

12 ‘‘(3) PERIODIC AUDIT.—–The Center shall be 

13 subject to periodic audit by the Comptroller General. 

14 ‘‘(d) ADVISORY COUNCIL.— 

15 ‘‘(1) IN GENERAL.—To ensure transparency, 

16 the Secretary shall establish through the Agency’s 

17 National Advisory Council, an advisory council (re18 ferred to in this section as the ‘Council’) that in19 cludes representatives from the scientific research, 

20 patient, provider, and health industry communities. 

21 ‘‘(2) COMPOSITION OF COUNCIL.— 

22 ‘‘(A) IN GENERAL.—The members of the 

23 Council shall consist of— 

24 ‘‘(i) 2 ex officio members who shall 

25 be— 


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1 ‘‘(I) the Director; and 

2 ‘‘(II) the Chief Medical Officer of 

3 the Centers for Medicare & Medicaid 

4 Services; and 

5 ‘‘(ii) 19 additional members who shall 

6 represent broad constituencies of stake7 holders. 

8 ‘‘(B) QUALIFICATIONS.— 

9 ‘‘(i) DIVERSE REPRESENTATION OF

10 PERSPECTIVES.—The members of the 

11 Council shall represent a broad range of 

12 perspectives and shall collectively have ex13 perience in the following areas: 

14 ‘‘(I) Epidemiology. 

15 ‘‘(II) Health services research. 

16 ‘‘(III) Bioethics. 

17 ‘‘(IV) Communication and deci18 sion sciences. 

19 ‘‘(V) Health economics. 

20 ‘‘(VI) Safe use of medical prod21 ucts. 

22 ‘‘(VII) The practice of medicine. 

23 ‘‘(ii) DIVERSE REPRESENTATION OF

24 HEALTH CARE COMMUNITY.—At least one 


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1 member shall represent each of the fol2 lowing health care communities: 

3 ‘‘(I) Consumers. 

4 ‘‘(II) Practicing physicians, in5 cluding surgeons. 

6 ‘‘(III) Nurses. 

7 ‘‘(IV) State licensed practitioners 

8 and other health care professionals. 

9 ‘‘(V) Employers. 

10 ‘‘(VI) Public payers. 

11 ‘‘(VII) Insurance plans. 

12 ‘‘(VIII) Clinical researchers who 

13 conduct research on behalf of pharma14 ceutical or device manufacturers. 

15 ‘‘(IX) Clinical researchers who 

16 conduct research related to personal17 ized medicine. 

18 ‘‘(X) Clinical researchers who 

19 conduct research related to reducing 

20 health disparities. 

21 ‘‘(3) APPOINTMENT.—The Secretary or the 

22 Secretary’s designee shall appoint the members of 

23 the Council. 

24 ‘‘(4) TERMS.— 


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1 ‘‘(A) IN GENERAL.—–Except as provided 

2 in subparagraph (B), each member of the 

3 Council shall be appointed for a term of 4 

4 years. 

5 ‘‘(B) TERMS OF INITIAL APPOINTEES.—– 

6 Of the members first appointed— 

7 ‘‘(i) 10 shall be appointed for a term 

8 of 4 years; and 

9 ‘‘(ii) 9 shall be appointed for a term 

10 of 2 years. 

11 ‘‘(5) CONFLICTS OF INTEREST.—–In appointing 

12 the members of the Council, the Secretary shall take 

13 into consideration any financial conflicts of interest. 

14 ‘‘(e) RARE DISEASE RESEARCH.—In the case of a re15 search study of a rare disease, the Secretary shall appoint 

16 a clinical expert advisory panel for purposes of assisting 

17 in the design of such research study and determining the 

18 feasibility of recruiting for and conducting such research 

19 study. 

20 ‘‘(f) EXPERT ADVISORY PANELS.—The Center may 

21 appoint expert advisory panels to advise the Center and 

22 the agency, instrumentality, or entity conducting the re23 search regarding the research question involved and the 

24 research design or protocol, including important patient 

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1 pert advisory panels may include individuals with experi2 ence in the relevant topic, project, or category for which 

3 the panel is established, including practicing and research 

4 clinicians and relevant specialists and subspecialists. 

5 ‘‘(g) RESEARCH REQUIREMENTS.—Any research con6 ducted, supported, or synthesized under this section shall 

7 meet the following requirements: 

8 ‘‘(1) ENSURING TRANSPARENCY, CREDIBILITY, 

9 AND ACCESS.—The establishment of the agenda and 

10 conduct of the research shall be insulated from 

11 undue political or stakeholder influence, in accord12 ance with the following: 

13 ‘‘(A) Methods of conducting such research 

14 shall be scientifically based and take into ac15 count scientific advances in personalized medi16 cine and reduces treatment disparities that in17 clude ethnic and racial minorities and children. 

18 ‘‘(B) All aspects of the prioritization of re19 search, conduct of the research, and develop20 ment of conclusions based on the research shall 

21 be transparent to all stakeholders. 

22 ‘‘(C) The process and methods for con23 ducting such research shall be publicly docu24 mented and available to all stakeholders. 


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1 ‘‘(D) The Center shall establish a process 

2 for stakeholders involved to review and provide 

3 comment on the methods and findings of such 

4 research. 

5 ‘‘(2) STAKEHOLDER INPUT.—The priorities of 

6 the research, the research, and the dissemination of 

7 the research shall involve the consultation of pa8 tients, health care providers, experts in wellness and 

9 health promotion, and health care consumer rep10 resentatives through transparent mechanisms rec11 ommended by the Council. 

12 ‘‘(h) PUBLIC ACCESS TO HEALTH OUTCOMES INFOR13 MATION.— 

14 ‘‘(1) IN GENERAL.—To the extent practicable, 

15 not later than 180 days after receipt by the Center 

16 of a relevant report described in paragraph (2), ap17 propriate information contained in such report shall 

18 be posted on the official public Internet site of the 

19 Center, as applicable. 

20 ‘‘(2) RELEVANT REPORTS DESCRIBED.—For 

21 purposes of this section, a relevant report is each of 

22 the following submitted by a grantee or contractor 

23 of the Center: 

24 ‘‘(A) An interim progress report. 


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1 ‘‘(B) A draft final report that is available 

2 to stakeholders for review. 

3 ‘‘(C) Stakeholder comments and response 

4 to same. 

5 ‘‘(D) A final progress report on new re6 search submitted for publication by a peer re7 view journal. 

8 ‘‘(E) A final report. 

9 ‘‘(3) BENEFIT TO SUBPOPULATIONS.—All re10 ports described in paragraph (2) shall assess wheth11 er the research demonstrates a benefit of the ther12 apy with respect to a specific subpopulation of indi13 viduals, even if the outcome of the research dem14 onstrates that, on average, with respect to the gen15 eral population, the clinical benefits of the treatment 

16 do not exceed the harm. 

17 ‘‘(i) ACCESS BY CONGRESS AND THE COUNSEL TO

18 CENTER INFORMATION.—The Secretary shall establish a 

19 process for the Center to share with Congress reports and 

20 non-proprietary data of the Center. 

21 ‘‘(j) DISSEMINATION, INCORPORATION, AND FEED22 BACK OF INFORMATION.— 

23 ‘‘(1) DISSEMINATION.—The Center shall pro24 vide for the dissemination of findings produced by 

25 research supported, conducted, or synthesized under 


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1 this section to health care providers, patients, ven2 dors of health information technology focused on 

3 clinical decision support, appropriate professional as4 sociations, and Federal and private health plans. 

5 Center reports and recommendations shall not be 

6 construed as mandates for payment, coverage, or 

7 treatment. 

8 ‘‘(2) INCORPORATION.—The Center shall assist 

9 users of health information technology focused on 

10 clinical decision support to promote the timely incor11 poration of the findings described in paragraph (1) 

12 into clinical practices and to promote the ease of use 

13 of such incorporation. 

14 ‘‘(3) FEEDBACK.—The Center shall establish a 

15 process to receive feedback from providers, patients, 

16 vendors of health information technology focused on 

17 clinical decision support, appropriate professional as18 sociations, and Federal and private health plans 

19 about the value of the information disseminated 

20 under this section. 

21 ‘‘(k) REPORTS TO CONGRESS.— 

22 ‘‘(1) ANNUAL REPORTS.—Beginning not later 

23 than one year after the date of enactment of this 

24 section, the Director shall submit to Congress an an25 nual report on the activities of the Center and the 


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1 Council, and the research conducted, under this sec2 tion. 

3 ‘‘(2) ANALYSIS AND REVIEW.—Not later than 

4 December 31, 2011, the Secretary, shall submit to 

5 Congress a report on all activities conducted or sup6 ported under this section as of such date. Such re7 port shall— 

8 ‘‘(A) include an evaluation of the impact 

9 from such activities, the overall costs of such 

10 activities, and an analysis of the backlog of any 

11 research proposals approved but not funded; 

12 and 

13 ‘‘(B) address whether Congress should ex14 pand the responsibilities of the Center to in15 clude studies of the effectiveness of various as16 pects of the health care delivery system, includ17 ing health plans and delivery models, such as 

18 health plan features, benefit designs and per19 formance, and the ways in which health services 

20 are organized, managed, and delivered.’’. 


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1 SEC. 220. DEMONSTRATION PROGRAM TO INTEGRATE 

2 QUALITY IMPROVEMENT AND PATIENT SAFE3 TY TRAINING INTO CLINICAL EDUCATION OF 

4 HEALTH PROFESSIONALS. 

5 (a) IN GENERAL.—The Secretary may award grants 

6 to eligible entities or consortia under this section to carry 

7 out demonstration projects to develop and implement aca8 demic curricula that integrates quality improvement and 

9 patient safety in the clinical education of health profes10 sionals. Such awards shall be made on a competitive basis 

11 and pursuant to peer review. 

12 (b) ELIGIBILITY.—To be eligible to receive a grant 

13 under subsection (a), an entity or consortium shall— 

14 (1) submit to the Secretary an application at 

15 such time, in such manner, and containing such in16 formation as the Secretary may require; 

17 (2) be or include— 

18 (A) a health professions school; 

19 (B) a school of public health; 

20 (C) a school of social work; 

21 (D) a school of nursing; 

22 (E) a school of pharmacy; 

23 (F) an institution with a graduate medical 

24 education program; or 

25 (G) a school of health care administration; 


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1 (3) collaborate in the development of curricula 

2 described in subsection (a) with an organization that 

3 accredits such school or institution; 

4 (4) provide for the collection of data regarding 

5 the effectiveness of the demonstration project; and 

6 (5) provide matching funds in accordance with 

7 subsection (c). 

8 (c) MATCHING FUNDS.— 

9 (1) IN GENERAL.—The Secretary may award a 

10 grant to an entity or consortium under this section 

11 only if the entity or consortium agrees to make 

12 available non-Federal contributions toward the costs 

13 of the program to be funded under the grant in an 

14 amount that is not less than $1 for each $5 of Fed15 eral funds provided under the grant. 

16 (2) DETERMINATION OF AMOUNT CONTRIB17 UTED.—Non-Federal contributions under paragraph 

18 (1) may be in cash or in kind, fairly evaluated, in19 cluding equipment or services. Amounts provided by 

20 the Federal Government, or services assisted or sub21 sidized to any significant extent by the Federal Gov22 ernment, may not be included in determining the 

23 amount of such contributions. 

24 (d) EVALUATION.—The Secretary shall take such ac25 tion as may be necessary to evaluate the projects funded 


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1 under this section and publish, make publicly available, 

2 and disseminate the results of such evaluations on as wide 

3 a basis as is practicable. 

4 (e) REPORTS.—Not later than 2 years after the date 

5 of enactment of this section, and annually thereafter, the 

6 Secretary shall submit to the Committee on Health, Edu7 cation, Labor, and Pensions and the Committee on Fi8 nance of the Senate and the Committee on Energy and 

9 Commerce and the Committee on Ways and Means of the 

10 House of Representatives a report that— 

11 (1) describes the specific projects supported 

12 under this section; and 

13 (2) contains recommendations for Congress 

14 based on the evaluation conducted under subsection 

15 (d). 

16 SEC. 221. OFFICE OF WOMEN’S HEALTH. 

17 (a) HEALTH AND HUMAN SERVICES OFFICE ON

18 WOMEN’S HEALTH.— 

19 (1) ESTABLISHMENT.—Part A of title II of the 

20 Public Health Service Act (42 U.S.C. 202 et seq.) 

21 is amended by adding at the end the following: 

22 ‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON 

23 WOMEN’S HEALTH. 

24 ‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab25 lished within the Office of the Secretary, an Office on 


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1 Women’s Health (referred to in this section as the ‘Of2 fice’). The Office shall be headed by a Deputy Assistant 

3 Secretary for Women’s Health who may report to the Sec4 retary. 

5 ‘‘(b) DUTIES.—The Secretary, acting through the Of6 fice, with respect to the health concerns of women, shall— 

7 ‘‘(1) establish short-range and long-range goals 

8 and objectives within the Department of Health and 

9 Human Services and, as relevant and appropriate, 

10 coordinate with other appropriate offices on activi11 ties within the Department that relate to disease 

12 prevention, health promotion, service delivery, re13 search, and public and health care professional edu14 cation, for issues of particular concern to women 

15 throughout their lifespan; 

16 ‘‘(2) provide expert advice and consultation to 

17 the Secretary concerning scientific, legal, ethical, 

18 and policy issues relating to women’s health; 

19 ‘‘(3) monitor the Department of Health and 

20 Human Services’ offices, agencies, and regional ac21 tivities regarding women’s health and identify needs 

22 regarding the coordination of activities, including in23 tramural and extramural multidisciplinary activities; 

24 ‘‘(4) establish a Department of Health and 

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1 en’s Health, which shall be chaired by the Deputy 

2 Assistant Secretary for Women’s Health and com3 posed of senior level representatives from each of the 

4 agencies and offices of the Department of Health 

5 and Human Services; 

6 ‘‘(5) establish a National Women’s Health In7 formation Center to— 

8 ‘‘(A) facilitate the exchange of information 

9 regarding matters relating to health informa10 tion, health promotion, preventive health serv11 ices, research advances, and education in the 

12 appropriate use of health care; 

13 ‘‘(B) facilitate access to such information; 

14 ‘‘(C) assist in the analysis of issues and 

15 problems relating to the matters described in 

16 this paragraph; and 

17 ‘‘(D) provide technical assistance with re18 spect to the exchange of information (including 

19 facilitating the development of materials for 

20 such technical assistance); 

21 ‘‘(6) coordinate efforts to promote women’s 

22 health programs and policies with the private sector; 

23 and 

24 ‘‘(7) through publications and any other means 

25 appropriate, provide for the exchange of information 


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1 between the Office and recipients of grants, con2 tracts, and agreements under subsection (c), and be3 tween the Office and health professionals and the 

4 general public. 

5 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU6 TIES.— 

7 ‘‘(1) AUTHORITY.—In carrying out subsection 

8 (b), the Secretary may make grants to, and enter 

9 into cooperative agreements, contracts, and inter10 agency agreements with, public and private entities, 

11 agencies, and organizations. 

12 ‘‘(2) EVALUATION AND DISSEMINATION.—The 

13 Secretary shall directly or through contracts with 

14 public and private entities, agencies, and organiza15 tions, provide for evaluations of projects carried out 

16 with financial assistance provided under paragraph 

17 (1) and for the dissemination of information devel18 oped as a result of such projects. 

19 ‘‘(d) REPORTS.—Not later than 1 year after the date 

20 of enactment of this section, and every second year there21 after, the Secretary shall prepare and submit to the appro22 priate committees of Congress a report describing the ac23 tivities carried out under this section during the period 

24 for which the report is being prepared. 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

2 purpose of carrying out this section, there are authorized 

3 to be appropriated such sums as may be necessary for 

4 each of the fiscal years 2010 through 2014.’’. 

5 (2) TRANSFER OF FUNCTIONS.—There are 

6 transferred to the Office on Women’s Health (estab7 lished under section 229 of the Public Health Serv8 ice Act, as added by this section), all functions exer9 cised by the Office on Women’s Health of the Public 

10 Health Service prior to the date of enactment of this 

11 section, including all personnel and compensation 

12 authority, all delegation and assignment authority, 

13 and all remaining appropriations. All orders, deter14 minations, rules, regulations, permits, agreements, 

15 grants, contracts, certificates, licenses, registrations, 

16 privileges, and other administrative actions that— 

17 (A) have been issued, made, granted, or al18 lowed to become effective by the President, any 

19 Federal agency or official thereof, or by a court 

20 of competent jurisdiction, in the performance of 

21 functions transferred under this paragraph; and 

22 (B) are in effect at the time this section 

23 takes effect, or were final before the date of en24 actment of this section and are to become effec25 tive on or after such date, 


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1 shall continue in effect according to their terms until 

2 modified, terminated, superseded, set aside, or re3 voked in accordance with law by the President, the 

4 Secretary, or other authorized official, a court of 

5 competent jurisdiction, or by operation of law. 

6 (b) CENTERS FOR DISEASE CONTROL AND PREVEN7 TION OFFICE OF WOMEN’S HEALTH.—Part A of title III 

8 of the Public Health Service Act (42 U.S.C. 241 et seq.) 

9 is amended by adding at the end the following: 

10 ‘‘SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVEN11 TION OFFICE OF WOMEN’S HEALTH. 

12 ‘‘(a) ESTABLISHMENT.—There is established within 

13 the Office of the Director of the Centers for Disease Con14 trol and Prevention, an office to be known as the Office 

15 of Women’s Health (referred to in this section as the ‘Of16 fice’). The Office shall be headed by a director who shall 

17 be appointed by the Director of such Centers. 

18 ‘‘(b) PURPOSE.—The Director of the Office shall— 

19 ‘‘(1) report to the Director of the Centers for 

20 Disease Control and Prevention on the current level 

21 of the Centers’ activity regarding women’s health 

22 conditions across, where appropriate, age, biological, 

23 and sociocultural contexts, in all aspects of the Cen24 ters’ work, including prevention programs, public 

25 and professional education, services, and treatment; 


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1 ‘‘(2) establish short-range and long-range goals 

2 and objectives within the Centers for women’s health 

3 and, as relevant and appropriate, coordinate with 

4 other appropriate offices on activities within the 

5 Centers that relate to prevention, research, edu6 cation and training, service delivery, and policy de7 velopment, for issues of particular concern to 

8 women; 

9 ‘‘(3) identify projects in women’s health that 

10 should be conducted or supported by the Centers; 

11 ‘‘(4) consult with health professionals, non12 governmental organizations, consumer organizations, 

13 women’s health professionals, and other individuals 

14 and groups, as appropriate, on the policy of the Cen15 ters with regard to women; and 

16 ‘‘(5) serve as a member of the Department of 

17 Health and Human Services Coordinating Com18 mittee on Women’s Health (established under sec19 tion 229(b)(4)). 

20 ‘‘(c) DEFINITION.—As used in this section, the term 

21 ‘women’s health conditions’, with respect to women of all 

22 age, ethnic, and racial groups, means diseases, disorders, 

23 and conditions— 

24 ‘‘(1) unique to, significantly more serious for, 

25 or significantly more prevalent in women; and 


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1 ‘‘(2) for which the factors of medical risk or 

2 type of medical intervention are different for women, 

3 or for which there is reasonable evidence that indi4 cates that such factors or types may be different for 

5 women. 

6 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 

7 purpose of carrying out this section, there are authorized 

8 to be appropriated such sums as may be necessary for 

9 each of the fiscal years 2010 through 2014.’’. 

10 (c) OFFICE OF WOMEN’S HEALTH RESEARCH.—Sec11 tion 486(a) of the Public Health Service Act (42 U.S.C. 

12 287d(a)) is amended by inserting ‘‘and who shall report 

13 directly to the Director’’ before the period at the end 

14 thereof . 

15 (d) SUBSTANCE ABUSE AND MENTAL HEALTH

16 SERVICES ADMINISTRATION.—Section 501(f) of the Pub17 lic Health Service Act (42 U.S.C. 290aa(f)) is amended— 

18 (1) in paragraph (1), by inserting ‘‘who shall 

19 report directly to the Administrator’’ before the pe20 riod; 

21 (2) by redesignating paragraph (4) as para22 graph (5); and 

23 (3) by inserting after paragraph (3), the fol24 lowing: 


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1 ‘‘(4) OFFICE.—Nothing in this subsection shall 

2 be construed to preclude the Secretary from estab3 lishing within the Substance Abuse and Mental 

4 Health Administration an Office of Women’s 

5 Health.’’. 

6 (e) AGENCY FOR HEALTHCARE RESEARCH AND

7 QUALITY ACTIVITIES REGARDING WOMEN’S HEALTH..— 

8 Part C of title IX of the Public Health Service Act (42 

9 U.S.C. 299c et seq.) is amended— 

10 (1) by redesignating sections 925 and 926 as 

11 sections 926 and 927, respectively; and 

12 (2) by inserting after section 924 the following: 

13 ‘‘SEC. 925. ACTIVITIES REGARDING WOMEN’S HEALTH. 

14 ‘‘(a) ESTABLISHMENT.—There is established within 

15 the Office of the Director, an Office of Women’s Health 

16 and Gender-Based Research (referred to in this section 

17 as the ‘Office’). The Office shall be headed by a director 

18 who shall be appointed by the Director of Healthcare and 

19 Research Quality. 

20 ‘‘(b) PURPOSE.—The official designated under sub21 section (a) shall— 

22 ‘‘(1) report to the Director on the current 

23 Agency level of activity regarding women’s health, 

24 across, where appropriate, age, biological, and 

25 sociocultural contexts, in all aspects of Agency work, 


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1 including the development of evidence reports and 

2 clinical practice protocols and the conduct of re3 search into patient outcomes, delivery of health care 

4 services, quality of care, and access to health care; 

5 ‘‘(2) establish short-range and long-range goals 

6 and objectives within the Agency for research impor7 tant to women’s health and, as relevant and appro8 priate, coordinate with other appropriate offices on 

9 activities within the Agency that relate to health 

10 services and medical effectiveness research, for 

11 issues of particular concern to women; 

12 ‘‘(3) identify projects in women’s health that 

13 should be conducted or supported by the Agency; 

14 ‘‘(4) consult with health professionals, non15 governmental organizations, consumer organizations, 

16 women’s health professionals, and other individuals 

17 and groups, as appropriate, on Agency policy with 

18 regard to women; and 

19 ‘‘(5) serve as a member of the Department of 

20 Health and Human Services Coordinating Com21 mittee on Women’s Health (established under sec22 tion 229(b)(4)).’’. 

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

24 purpose of carrying out this section, there are authorized 


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1 to be appropriated such sums as may be necessary for 

2 each of the fiscal years 2010 through 2014.’’. 

3 (f) HEALTH RESOURCES AND SERVICES ADMINIS4 TRATION OFFICE OF WOMEN’S HEALTH.—Title VII of 

5 the Social Security Act (42 U.S.C. 901 et seq.) is amended 

6 by adding at the end the following: 

7 ‘‘SEC. 713. OFFICE OF WOMEN’S HEALTH. 

8 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab9 lish within the Office of the Administrator of the Health 

10 Resources and Services Administration, an office to be 

11 known as the Office of Women’s Health. The Office shall 

12 be headed by a director who shall be appointed by the Ad13 ministrator. 

14 ‘‘(b) PURPOSE.—The Director of the Office shall— 

15 ‘‘(1) report to the Administrator on the current 

16 Administration level of activity regarding women’s 

17 health across, where appropriate, age, biological, and 

18 sociocultural contexts; 

19 ‘‘(2) establish short-range and long-range goals 

20 and objectives within the Health Resources and 

21 Services Administration for women’s health and, as 

22 relevant and appropriate, coordinate with other ap23 propriate offices on activities within the Administra24 tion that relate to health care provider training, 


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1 health service delivery, research, and demonstration 

2 projects, for issues of particular concern to women; 

3 ‘‘(3) identify projects in women’s health that 

4 should be conducted or supported by the bureaus of 

5 the Administration; 

6 ‘‘(4) consult with health professionals, non7 governmental organizations, consumer organizations, 

8 women’s health professionals, and other individuals 

9 and groups, as appropriate, on Administration policy 

10 with regard to women; and 

11 ‘‘(5) serve as a member of the Department of 

12 Health and Human Services Coordinating Com13 mittee on Women’s Health (established under sec14 tion 229(b)(4) of the Public Health Service Act). 

15 ‘‘(c) CONTINUED ADMINISTRATION OF EXISTING

16 PROGRAMS.—The Director of the Office shall assume the 

17 authority for the development, implementation, adminis18 tration, and evaluation any projects carried out through 

19 the Health Resources and Services Administration relat20 ing to women’s health on the date of enactment of this 

21 section. 

22 ‘‘(d) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) ADMINISTRATION.—The term ‘Administra24 tion’ means the Health Resources and Services Ad25 ministration. 


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1 ‘‘(2) ADMINISTRATOR.—The term ‘Adminis2 trator’ means the Administrator of the Health Re3 sources and Services Administration. 

4 ‘‘(3) OFFICE.—The term ‘Office’ means the Of5 fice of Women’s Health established under this sec6 tion in the Administration. 

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

8 purpose of carrying out this section, there are authorized 

9 to be appropriated such sums as may be necessary for 

10 each of the fiscal years 2010 through 2014.’’. 

11 (g) FOOD AND DRUG ADMINISTRATION OFFICE OF

12 WOMEN’S HEALTH.—Chapter X of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend14 ed by adding at the end the following: 

15 ‘‘SEC. 1011. OFFICE OF WOMEN’S HEALTH. 

16 ‘‘(a) ESTABLISHMENT.—There is established within 

17 the Office of the Commissioner, an office to be known as 

18 the Office of Women’s Health (referred to in this section 

19 as the ‘Office’). The Office shall be headed by a director 

20 who shall be appointed by the Commissioner of Food and 

21 Drugs. 

22 ‘‘(b) PURPOSE.—The Director of the Office shall— 

23 ‘‘(1) report to the Commissioner of Food and 

24 Drugs on current Food and Drug Administration 

25 (referred to in this section as the ‘Administration’) 


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1 levels of activity regarding women’s participation in 

2 clinical trials and the analysis of data by sex in the 

3 testing of drugs, medical devices, and biological 

4 products across, where appropriate, age, biological, 

5 and sociocultural contexts; 

6 ‘‘(2) establish short-range and long-range goals 

7 and objectives within the Administration for issues 

8 of particular concern to women’s health within the 

9 jurisdiction of the Administration, including, where 

10 relevant and appropriate, adequate inclusion of 

11 women and analysis of data by sex in Administration 

12 protocols and policies; 

13 ‘‘(3) provide information to women and health 

14 care providers on those areas in which differences 

15 between men and women exist; 

16 ‘‘(4) consult with pharmaceutical, biologics, and 

17 device manufacturers, health professionals with ex18 pertise in women’s issues, consumer organizations, 

19 and women’s health professionals on Administration 

20 policy with regard to women; 

21 ‘‘(5) make annual estimates of funds needed to 

22 monitor clinical trials and analysis of data by sex in 

23 accordance with needs that are identified; and 

24 ‘‘(6) serve as a member of the Department of 

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1 mittee on Women’s Health (established under sec2 tion 229(b)(4) of the Public Health Service Act). 

3 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purpose of carrying out this section, there are authorized 

5 to be appropriated such sums as may be necessary for 

6 each of the fiscal years 2010 through 2014.’’. 

7 (h) NO NEW REGULATORY AUTHORITY.—Nothing in 

8 this section and the amendments made by this section may 

9 be construed as establishing regulatory authority or modi10 fying any existing regulatory authority. 

11 (i) LIMITATION ON TERMINATION.—Notwithstanding 

12 any other provision of law, a Federal office of women’s 

13 health (including the Office of Research on Women’s 

14 Health of the National Institutes of Health) or Federal 

15 appointive position with primary responsibility over wom16 en’s health issues (including the Associate Administrator 

17 for Women’s Services under the Substance Abuse and 

18 Mental Health Services Administration) that is in exist19 ence on the date of enactment of this section shall not 

20 be terminated, reorganized, or have any of it’s powers or 

21 duties transferred unless such termination, reorganization, 

22 or transfer is approved by Congress through the adoption 

23 of a concurrent resolution of approval. 

24 (j) RULE OF CONSTRUCTION.—Nothing in this sec25 tion (or the amendments made by this section) shall be 


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1 construed to limit the authority of the Secretary of Health 

2 and Human Services with respect to women’s health, or 

3 with respect to activities carried out through the Depart4 ment of Health and Human Services on the date of enact5 ment of this section. 

6 SEC. 222. ADMINISTRATIVE SIMPLIFICATION. 

7 (a) STANDARDS FOR FINANCIAL AND ADMINISTRA8 TIVE TRANSACTIONS.— 

9 (1) IN GENERAL.—The Secretary shall adopt 

10 and regularly update standards, implementation 

11 specifications, and operating rules for the electronic 

12 exchange and use of health information for purposes 

13 of financial and administrative transactions (as pro14 vided for in paragraph (2)). 

15 (2) ADDITIONAL REQUIREMENTS FOR FINAN16 CIAL AND ADMINISTRATIVE TRANSACTIONS.—The 

17 standards, implementation specifications, and oper18 ating rules provided for in paragraph (1) shall— 

19 (A) be unique with no conflicting or redun20 dant standards; 

21 (B) be authoritative, requiring no addi22 tional standards or companion guides; 

23 (C) be comprehensive and robust, requiring 

24 minimal augmentation by paper transactions or 

25 clarification by phone calls; 


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1 (D) enable the real time determination of 

2 a patient’s financial responsibility at the point 

3 of service and, to the extent possible, prior to 

4 service, including whether a patient is eligible 

5 for a specific service with a specific physician at 

6 a specific facility, which may include a machine7 readable health plan identification card; 

8 (E) provide for timely acknowledgment; 

9 and 

10 (F) require that all data elements within a 

11 standard or specification (such as reason and 

12 remark codes) be described in unambiguous 

13 terms (with no optional fields permitted and a 

14 requirement that data elements be either re15 quired or conditioned upon set values in other 

16 fields) with additional conditions being prohib17 ited. 

18 (3) TIME FOR ADOPTION.—Not later than 2 

19 years after the date of enactment of this section, the 

20 Secretary shall adopt standards, implementation 

21 specifications, and operating rules under this sec22 tion. 

23 (4) REQUIREMENTS FOR INITIAL STAND24 ARDS.—The initial set of standards, implementation 


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1 specifications, and operating rules under paragraph 

2 (1) shall include— 

3 (A) requirements to clarify, refine, and ex4 pand, as needed, standards required under sec5 tion 1173 of the Social Security Act; 

6 (B) requirements for acknowledgments, 

7 such as those for receipt of a claim; 

8 (C) requirements to permit electronic 

9 funds transfers (to allow automated reconcili10 ation with the related health care payment and 

11 remittance advice); 

12 (D) the requirements of timely and trans13 parent claim and denial management processes, 

14 including tracking, adjudication, and appeal 

15 processing (for all participants, including health 

16 insurance issuers, health care providers, and 

17 patients); and 

18 (E) other requirements relating to admin19 istrative simplification as identified by the Sec20 retary, in consultation with stakeholders. 

21 (5) BUILDING ON EXISTING STANDARDS.—In 

22 developing the standards, implementation specifica23 tions, and operating rules under paragraph (1), the 

24 Secretary shall build upon existing and planned 


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1 standards, implementation specifications, and oper2 ating rules. 

3 (6) EXPEDITED PROCEDURES FOR ADOPTION

4 OF ADDITIONS AND MODIFICATIONS TO STAND5 ARDS.—Notwithstanding any other provision of law, 

6 the Secretary may use the following expedited proce7 dures for purposes of paragraph (1): 

8 (A) EXPEDITED UPGRADE PROGRAM.—The 

9 Secretary shall provide for an expedited up10 grade program (in this paragraph referred to as 

11 the ‘‘upgrade program’’), in accordance with 

12 this paragraph, to develop and approve addi13 tions and modifications to the standards de14 scribed in paragraph (4) to improve the quality 

15 of such standards or to extend the functionality 

16 of such standards to meet evolving require17 ments in health care. 

18 (B) PUBLICATION OF NOTICES.—Under 

19 the upgrade program: 

20 (i) VOLUNTARY NOTICE OF INITI21 ATION OF PROCESS.—Not later than 30 

22 days after the date the Secretary receives 

23 a notice from a standard setting organiza24 tion that the organization is initiating a 

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1 tion to a standard described in paragraph 

2 (4), the Secretary shall publish a notice in 

3 the Federal Register that— 

4 (I) identifies the subject matter 

5 of the addition or modification; 

6 (II) provides a description of how 

7 persons may participate in the devel8 opment process; and 

9 (III) invites public participation 

10 in such process. 

11 (ii) VOLUNTARY NOTICE OF PRELIMI12 NARY DRAFT OF ADDITIONS OR MODIFICA13 TIONS TO STANDARDS.—Not later than 30 

14 days after the date the Secretary receives 

15 a notice from a standard setting organiza16 tion that the organization has prepared a 

17 preliminary draft of an addition or modi18 fication to a standard described in para19 graph (4), the Secretary shall publish a no20 tice in the Federal Register that— 

21 (I) identifies the subject matter 

22 of (and summarizes) the addition or 

23 modification; 

24 (II) specifies the procedure for 

25 obtaining the draft; 


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1 (III) provides a description of 

2 how persons may submit comments in 

3 writing and at any public hearing or 

4 meeting held by the organization on 

5 the addition or modification; and 

6 (IV) invites submission of such 

7 comments and participation in such 

8 hearing or meeting without requiring 

9 the public to pay a fee to participate. 

10 (iii) NOTICE OF PROPOSED ADDITION

11 OR MODIFICATION TO STANDARDS.—Not 

12 later than 30 days after the date the Sec13 retary receives a notice from a standard 

14 setting organization that the organization 

15 has a proposed addition or modification to 

16 a standard described in paragraph (4) that 

17 the organization intends to submit under 

18 subparagraph (D)(iii), the Secretary shall 

19 publish a notice in the Federal Register 

20 that contains, with respect to the proposed 

21 addition or modification, the information 

22 required in the notice under clause (ii) 

23 with respect to the addition or modifica24 tion. 


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1 (iv) CONSTRUCTION.—Nothing in this 

2 paragraph shall be construed as requiring 

3 a standard setting organization to request 

4 the notices described in clauses (i) and (ii) 

5 with respect to an addition or modification 

6 to a standard in order to qualify for an ex7 pedited determination under subparagraph 

8 (C) with respect to a proposal submitted to 

9 the Secretary for adoption of such addition 

10 or modification. 

11 (C) PROVISION OF EXPEDITED DETER12 MINATION.—Under the upgrade program and 

13 with respect to a proposal by a standard setting 

14 organization for an addition or modification to 

15 a standard described in paragraph (4), if the 

16 Secretary determines that the standard setting 

17 organization developed such addition or modi18 fication in accordance with the requirements of 

19 subparagraph (D) and the National Committee 

20 on Vital and Health Statistics recommends ap21 proval of such addition or modification under 

22 subparagraph (E), the Secretary shall provide 

23 for expedited treatment of such proposal in ac24 cordance with subparagraph (F). 


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1 (D) REQUIREMENTS.—The requirements 

2 under this subparagraph with respect to a pro3 posed addition or modification to a standard by 

4 a standard setting organization are the fol5 lowing: 

6 (i) REQUEST FOR PUBLICATION OF

7 NOTICE.—The standard setting organiza8 tion submits to the Secretary a request for 

9 publication in the Federal Register of a no10 tice described in subparagraph (B)(iii) for 

11 the proposed addition or modification. 

12 (ii) PROCESS FOR RECEIPT AND CON13 SIDERATION OF PUBLIC COMMENT.—The 

14 standard setting organization provides for 

15 a process through which, after the publica16 tion of the notice referred to under clause 

17 (i), the organization— 

18 (I) receives and responds to pub19 lic comments submitted on a timely 

20 basis on the proposed addition or 

21 modification before submitting such 

22 proposed addition or modification to 

23 the National Committee on Vital and 

24 Health Statistics under clause (iii); 


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1 (II) makes publicly available a 

2 written explanation for its response in 

3 the proposed addition or modification 

4 to comments submitted on a timely 

5 basis; and 

6 (III) makes public comments re7 ceived under clause (I) available, or 

8 provides access to such comments, to 

9 the Secretary. 

10 (iii) SUBMITTAL OF FINAL PROPOSED

11 ADDITION OR MODIFICATION TO NCVHS.— 

12 After completion of the process under 

13 clause (ii), the standard setting organiza14 tion submits the proposed addition or 

15 modification to the National Committee on 

16 Vital and Health Statistics for review and 

17 consideration under subparagraph (E). 

18 Such submission shall include information 

19 on the organization’s compliance with the 

20 notice and comment requirements (and re21 sponses to those comments) under clause 

22 (ii). 

23 (E) HEARINGS AND RECOMMENDATIONS

24 BY NATIONAL COMMITTEE ON VITAL AND

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1 gram, upon receipt of a proposal submitted by 

2 a standard setting organization under subpara3 graph (D)(iii) for the adoption of an addition or 

4 modification to a standard, the National Com5 mittee on Vital and Health Statistics shall pro6 vide notice to the public and a reasonable op7 portunity for public testimony at a hearing on 

8 such addition or modification. The Secretary 

9 may participate in such hearing in such capac10 ity (including presiding ex officio) as the Sec11 retary shall determine appropriate. Not later 

12 than 120 days after the date of receipt of the 

13 proposal, the Committee shall submit to the 

14 Secretary its recommendation to adopt (or not 

15 adopt) the proposed addition or modification. 

16 (F) DETERMINATION BY SECRETARY TO

17 ACCEPT OR REJECT NATIONAL COMMITTEE ON

18 VITAL AND HEALTH STATISTICS RECOMMENDA19 TION.— 

20 (i) TIMELY DETERMINATION.—Under 

21 the upgrade program, if the National Com22 mittee on Vital and Health Statistics sub23 mits to the Secretary a recommendation 

24 under subparagraph (E) to adopt a pro25 posed addition or modification, not later 


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1 than 90 days after the date of receipt of 

2 such recommendation the Secretary shall 

3 make a determination to accept or reject 

4 the recommendation and shall publish no5 tice of such determination in the Federal 

6 Register not later than 90 days after the 

7 date of the determination. 

8 (ii) CONTENTS OF NOTICE.—If the 

9 determination is to reject the recommenda10 tion, such notice shall include the reasons 

11 for the rejection. If the determination is to 

12 accept the recommendation, as part of 

13 such notice the Secretary shall promulgate 

14 the modified standard (including the ac15 cepted proposed addition or modification 

16 accepted) as a final rule under this sub17 section without any further notice or public 

18 comment period. 

19 (iii) LIMITATION ON CONSIDER20 ATION.—The Secretary shall not consider a 

21 proposal under this subparagraph unless 

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1 lic comment) have been met with respect to 

2 the proposal. 

3 (G) EXEMPTION FROM PAPERWORK RE4 DUCTION ACT.—Chapter 35 of title 44, United 

5 States Code, shall not apply to a final rule pro6 mulgated under subparagraph (F). 

7 (H) TREATMENT AS SATISFYING REQUIRE8 MENTS FOR NOTICE AND COMMENT.—Any re9 quirements under section 553 of title 5, United 

10 States Code, relating to notice and an oppor11 tunity for public comment with respect to a 

12 final rule promulgated under subparagraph (F) 

13 shall be treated as having been met by meeting 

14 the requirements of the notice and opportunity 

15 for public comment provided under provisions 

16 of subparagraphs (B)(iii), (D), and (E). 

17 (I) MODIFICATION DEFINED.—For pur18 poses of this section, the term ‘‘modification’’ 

19 includes a new version or a version upgrade. 

20 (7) IMPLEMENTATION AND ENFORCEMENT.— 

21 Not later than 2 years after the date of enactment 

22 of this section, the Secretary shall submit to the ap23 propriate committees of Congress a plan for the im24 plementation and enforcement, by not later than 5 

25 years after such date of enactment, of the standards, 


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1 implementation specifications, and operating rules 

2 provided for under paragraph (1). 

3 (b) HEALTH PLAN IDENTIFIER.—Not later than 1 

4 year after the date of enactment of this section, the Sec5 retary shall promulgate a final rule to establish a National 

6 Health Plan Identifier system. 

7 SEC. 223. PATIENT NAVIGATOR PROGRAM. 

8 Section 340A of the Public Health Service Act (42 

9 U.S.C. 256a) is amended— 

10 (1) in subsection (e), by adding at the end the 

11 following: 

12 ‘‘(3) MINIMUM CORE PROFICIENCIES.—The 

13 Secretary shall not award a grant to an entity under 

14 this section unless such entity provides assurances 

15 that patient navigators recruited, assigned, trained, 

16 or employed using grant funds meet minimum core 

17 proficiencies, as defined by the entity that submits 

18 the application, that are tailored for the main focus 

19 or intervention of the navigator involved.’’; and 

20 (2) in subsection (m)— 

21 (A) in paragraph (1), by striking ‘‘and 

22 $3,500,000 for fiscal year 2010.’’ and inserting 

23 ‘‘$3,500,000 for fiscal year 2010, and such 

24 sums as may be necessary for each of fiscal 

25 years 2011 through 2015.’’; and 


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1 (B) in paragraph (2), by striking ‘‘2010’’ 

2 and inserting ‘‘2015’’. 

3 SEC. 224. AUTHORIZATION OF APPROPRIATIONS. 

4 Except where otherwise provided in this subtitle (or 

5 an amendment made by this subtitle), there is authorized 

6 to be appropriated such sums as may be necessary to carry 

7 out this subtitle (and such amendments made by this sub8 title). 

9 Subtitle C—Civil and Criminal 

10 Penalties for Acts Involving 

11 Federal Health Care Programs; 

12 Exception to Limitation on Cer13 tain Physician Referrals 

14 SEC. 231. SAFE HARBORS TO ANTIKICKBACK CIVIL PEN15 ALTIES AND CRIMINAL PENALTIES FOR PRO16 VISION OF HEALTH INFORMATION TECH17 NOLOGY AND TRAINING SERVICES. 

18 (a) FOR CIVIL PENALTIES.—Section 1128A of the 

19 Social Security Act (42 U.S.C. 1320a–7a) is amended— 

20 (1) in subsection (b), by adding at the end the 

21 following new paragraph: 

22 ‘‘(4) For purposes of this subsection, inducements to 

23 reduce or limit services described in paragraph (1) shall 

24 not include the practical or other advantages resulting 


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1 from health information technology or related installation, 

2 maintenance, support, or training services.’’; and 

3 (2) in subsection (i), by adding at the end the 

4 following new paragraph: 

5 ‘‘(8) The term ‘health information technology’ 

6 means hardware, software, license, right, intellectual 

7 property, equipment, or other information tech8 nology (including new versions, upgrades, and 

9 connectivity) designed or provided primarily for the 

10 electronic creation, maintenance, or exchange of 

11 health information to better coordinate care or im12 prove health care quality, efficiency, or research.’’. 

13 (b) FOR CRIMINAL PENALTIES.—Section 1128B of 

14 such Act (42 U.S.C. 1320a–7b) is amended— 

15 (1) in subsection (b)(3)— 

16 (A) in subparagraph (G), by striking 

17 ‘‘and’’ at the end; 

18 (B) in the subparagraph (H) added by sec19 tion 237(d) of the Medicare Prescription Drug, 

20 Improvement, and Modernization Act of 2003 

21 (Public Law 108–173; 117 Stat. 2213)— 

22 (i) by moving such subparagraph 2 

23 ems to the left; and 

24 (ii) by striking the period at the end 

25 and inserting a semicolon; 


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1 (C) in the subparagraph (H) added by sec2 tion 431(a) of such Act (117 Stat. 2287)— 

3 (i) by redesignating such subpara4 graph as subparagraph (I); 

5 (ii) by moving such subparagraph 2 

6 ems to the left; and 

7 (iii) by striking the period at the end 

8 and inserting ‘‘; and’’; and 

9 (D) by adding at the end the following new 

10 subparagraph: 

11 ‘‘(J) any nonmonetary remuneration (in the 

12 form of health information technology, as defined in 

13 section 1128A(i)(8), or related installation, mainte14 nance, support or training services) made to a per15 son by a specified entity (as defined in subsection 

16 (g)) if— 

17 ‘‘(i) the provision of such remuneration is 

18 without an agreement between the parties or 

19 legal condition that— 

20 ‘‘(I) limits or restricts the use of the 

21 health information technology to services 

22 provided by the physician to individuals re23 ceiving services at the specified entity; 

24 ‘‘(II) limits or restricts the use of the 

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1 tion with other health information tech2 nology; or 

3 ‘‘(III) conditions the provision of such 

4 remuneration on the referral of patients or 

5 business to the specified entity; 

6 ‘‘(ii) such remuneration is arranged for in 

7 a written agreement that is signed by the par8 ties involved (or their representatives) and that 

9 specifies the remuneration solicited or received 

10 (or offered or paid) and states that the provi11 sion of such remuneration is made for the pri12 mary purpose of better coordination of care or 

13 improvement of health quality, efficiency, or re14 search; and 

15 ‘‘(iii) the specified entity providing the re16 muneration (or a representative of such entity) 

17 has not taken any action to disable any basic 

18 feature of any hardware or software component 

19 of such remuneration that would permit inter20 operability.’’; and 

21 (2) by adding at the end the following new sub22 section: 

23 ‘‘(g) SPECIFIED ENTITY DEFINED.—For purposes of 

24 subsection (b)(3)(J), the term ‘specified entity’ means an 

25 entity that is a hospital, group practice, prescription drug 


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1 plan sponsor, a Medicare Advantage organization, or any 

2 other such entity specified by the Secretary, considering 

3 the goals and objectives of this section, as well as the goals 

4 to better coordinate the delivery of health care and to pro5 mote the adoption and use of health information tech6 nology.’’. 

7 (c) EFFECTIVE DATE AND EFFECT ON STATE

8 LAWS.— 

9 (1) EFFECTIVE DATE.—The amendments made 

10 by subsections (a) and (b) shall take effect on the 

11 date that is 120 days after the date of the enact12 ment of this Act. 

13 (2) PREEMPTION OF STATE LAWS.—No State 

14 (as defined in section 1101(a) of the Social Security 

15 Act (42 U.S.C. 1301(a)) for purposes of title XI of 

16 such Act) shall have in effect a State law that im17 poses a criminal or civil penalty for a transaction de18 scribed in section 1128A(b)(4) or section 

19 1128B(b)(3)(J) of such Act, as added by subsections 

20 (a)(1) and (b), respectively, if the conditions de21 scribed in the respective provision, with respect to 

22 such transaction, are met. 

23 (d) STUDY AND REPORT TO ASSESS EFFECT OF

24 SAFE HARBORS ON HEALTH SYSTEM.— 


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1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services shall conduct a study to determine 

3 the impact of each of the safe harbors described in 

4 paragraph (3). In particular, the study shall examine 

5 the following: 

6 (A) The effectiveness of each safe harbor 

7 in increasing the adoption of health information 

8 technology. 

9 (B) The types of health information tech10 nology provided under each safe harbor. 

11 (C) The extent to which the financial or 

12 other business relationships between providers 

13 under each safe harbor have changed as a re14 sult of the safe harbor in a way that adversely 

15 affects or benefits the health care system or 

16 choices available to consumers. 

17 (D) The impact of the adoption of health 

18 information technology on health care quality, 

19 cost, and access under each safe harbor. 

20 (2) REPORT.—Not later than 3 years after the 

21 effective date described in subsection (c)(1), the Sec22 retary of Health and Human Services shall submit 

23 to Congress a report on the study under paragraph 

24 (1). 


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1 (3) SAFE HARBORS DESCRIBED.—For purposes 

2 of paragraphs (1) and (2), the safe harbors de3 scribed in this paragraph are— 

4 (A) the safe harbor under section 

5 1128A(b)(4) of such Act (42 U.S.C. 1320a– 

6 7a(b)(4)), as added by subsection (a)(1); and 

7 (B) the safe harbor under section 

8 1128B(b)(3)(J) of such Act (42 U.S.C. 1320a– 

9 7b(b)(3)(J)), as added by subsection (b). 

10 SEC. 232. EXCEPTION TO LIMITATION ON CERTAIN PHYSI11 CIAN REFERRALS (UNDER STARK) FOR PRO12 VISION OF HEALTH INFORMATION TECH13 NOLOGY AND TRAINING SERVICES TO 

14 HEALTH CARE PROFESSIONALS. 

15 (a) IN GENERAL.—Section 1877(b) of the Social Se16 curity Act (42 U.S.C. 1395nn(b)) is amended by adding 

17 at the end the following new paragraph: 

18 ‘‘(6) INFORMATION TECHNOLOGY AND TRAIN19 ING SERVICES.— 

20 ‘‘(A) IN GENERAL.—Any nonmonetary re21 muneration (in the form of health information 

22 technology or related installation, maintenance, 

23 support or training services) made by a speci24 fied entity to a physician if— 


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1 ‘‘(i) the provision of such remunera2 tion is without an agreement between the 

3 parties or legal condition that— 

4 ‘‘(I) limits or restricts the use of 

5 the health information technology to 

6 services provided by the physician to 

7 individuals receiving services at the 

8 specified entity; 

9 ‘‘(II) limits or restricts the use of 

10 the health information technology in 

11 conjunction with other health informa12 tion technology; or 

13 ‘‘(III) conditions the provision of 

14 such remuneration on the referral of 

15 patients or business to the specified 

16 entity; 

17 ‘‘(ii) such remuneration is arranged 

18 for in a written agreement that is signed 

19 by the parties involved (or their represent20 atives) and that specifies the remuneration 

21 made and states that the provision of such 

22 remuneration is made for the primary pur23 pose of better coordination of care or im24 provement of health quality, efficiency, or 

25 research; and 


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1 ‘‘(iii) the specified entity (or a rep2 resentative of such entity) has not taken 

3 any action to disable any basic feature of 

4 any hardware or software component of 

5 such remuneration that would permit 

6 interoperability. 

7 ‘‘(B) HEALTH INFORMATION TECHNOLOGY

8 DEFINED.—For purposes of this paragraph, the 

9 term ‘health information technology’ means 

10 hardware, software, license, right, intellectual 

11 property, equipment, or other information tech12 nology (including new versions, upgrades, and 

13 connectivity) designed or provided primarily for 

14 the electronic creation, maintenance, or ex15 change of health information to better coordi16 nate care or improve health care quality, effi17 ciency, or research. 

18 ‘‘(C) SPECIFIED ENTITY DEFINED.—For 

19 purposes of this paragraph, the term ‘specified 

20 entity’ means an entity that is a hospital, group 

21 practice, prescription drug plan sponsor, a 

22 Medicare Advantage organization, or any other 

23 such entity specified by the Secretary, consid24 ering the goals and objectives of this section, as 

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1 ery of health care and to promote the adoption 

2 and use of health information technology.’’. 

3 (b) EFFECTIVE DATE; EFFECT ON STATE LAWS.— 

4 (1) EFFECTIVE DATE.—The amendment made 

5 by subsection (a) shall take effect on the date that 

6 is 120 days after the date of the enactment of this 

7 Act. 

8 (2) PREEMPTION OF STATE LAWS.—No State 

9 (as defined in section 1101(a) of the Social Security 

10 Act (42 U.S.C. 1301(a)) for purposes of title XI of 

11 such Act) shall have in effect a State law that im12 poses a criminal or civil penalty for a transaction de13 scribed in section 1877(b)(6) of such Act, as added 

14 by subsection (a), if the conditions described in such 

15 section, with respect to such transaction, are met. 

16 (c) STUDY AND REPORT TO ASSESS EFFECT OF EX17 CEPTION ON HEALTH SYSTEM.— 

18 (1) IN GENERAL.—The Secretary of Health and 

19 Human Services shall conduct a study to determine 

20 the impact of the exception under section 1877(b)(6) 

21 of such Act (42 U.S.C. 1395nn(b)(6)), as added by 

22 subsection (a). In particular, the study shall examine 

23 the following: 


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1 (A) The effectiveness of the exception in 

2 increasing the adoption of health information 

3 technology. 

4 (B) The types of health information tech5 nology provided under the exception. 

6 (C) The extent to which the financial or 

7 other business relationships between providers 

8 under the exception have changed as a result of 

9 the exception in a way that adversely affects or 

10 benefits the health care system or choices avail11 able to consumers. 

12 (D) The impact of the adoption of health 

13 information technology on health care quality, 

14 cost, and access under the exception. 

15 (2) REPORT.—Not later than 3 years after the 

16 effective date described in subsection (b)(1), the Sec17 retary of Health and Human Services shall submit 

18 to Congress a report on the study under paragraph 

19 (1). 

20 SEC. 233. RULES OF CONSTRUCTION REGARDING USE OF 

21 CONSORTIA. 

22 (a) APPLICATION TO SAFE HARBOR FROM CRIMINAL

23 PENALTIES.—Section 1128B(b)(3) of the Social Security 

24 Act (42 U.S.C. 1320a–7b(b)(3)) is amended by adding 

25 after and below subparagraph (J), as added by section 


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1 231(b)(1), the following: ‘‘For purposes of subparagraph 

2 (J), nothing in such subparagraph shall be construed as 

3 preventing a specified entity, consistent with the specific 

4 requirements of such subparagraph, from forming a con5 sortium composed of health care providers, payers, em6 ployers, and other interested entities to collectively pur7 chase and donate health information technology, or from 

8 offering health care providers a choice of health informa9 tion technology products in order to take into account the 

10 varying needs of such providers receiving such products.’’. 

11 (b) APPLICATION TO STARK EXCEPTION.—Para12 graph (6) of section 1877(b) of the Social Security Act 

13 (42 U.S.C. 1395nn(b)), as added by section 232(a), is 

14 amended by adding at the end the following new subpara15 graph: 

16 ‘‘(D) RULE OF CONSTRUCTION.—For pur17 poses of subparagraph (A), nothing in such 

18 subparagraph shall be construed as preventing 

19 a specified entity, consistent with the specific 

20 requirements of such subparagraph, from— 

21 ‘‘(i) forming a consortium composed 

22 of health care providers, payers, employers, 

23 and other interested entities to collectively 

24 purchase and donate health information 

25 technology; or 


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1 ‘‘(ii) offering health care providers a 

2 choice of health information technology 

3 products in order to take into account the 

4 varying needs of such providers receiving 

5 such products.’’. 

6 TITLE III—IMPROVING THE 

7 HEALTH OF THE AMERICAN 

8 PEOPLE 

9 Subtitle A—Modernizing Disease 

10 Prevention and Public Health 

11 Systems 

12 SEC. 301. NATIONAL PREVENTION, HEALTH PROMOTION 

13 AND PUBLIC HEALTH COUNCIL. 

14 (a) ESTABLISHMENT.—The President shall establish 

15 a council to be known as the ‘‘National Prevention, Health 

16 Promotion and Public Health Council’’ (referred to in this 

17 section as the ‘‘Council’’). 

18 (b) CHAIRPERSON.—The President shall appoint an 

19 individual to serve as the chairperson of the Council. 

20 (c) COMPOSITION.—The Council shall be composed 

21 of— 

22 (1) the Secretary of Health and Human Serv23 ices; 

24 (2) the Secretary of Agriculture; 

25 (3) the Secretary of Education; 


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1 (4) the Chairman of the Federal Trade Com2 mission; 

3 (5) the Chairman of the Federal Communica4 tions Commission; 

5 (6) the Secretary of Transportation; 

6 (7) the Secretary of Defense; 

7 (8) the Secretary of Veterans Affairs; 

8 (9) the Secretary of the Interior; 

9 (10) the Secretary of Labor; 

10 (11) the Secretary of Homeland Security; 

11 (12) the Secretary of Housing and Urban De12 velopment; 

13 (13) the Director of the United States Patent 

14 and Trademark Office; 

15 (14) the Administrator of the Environmental 

16 Protection Agency; 

17 (15) the Director of the Domestic Policy Coun18 cil; 

19 (16) the Director of the Office of Personnel 

20 Management; 

21 (17) the Director of the Office of National 

22 Drug Control Policy; 

23 (18) the Chairman of the Corporation for Na24 tional and Community Service; and 


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1 (19) the head of any other Federal agency that 

2 the chairperson determines is appropriate. 

3 (d) PURPOSES AND DUTIES.—The Council shall— 

4 (1) provide coordination and leadership at the 

5 Federal level, and among all Federal departments 

6 and agencies, with respect to prevention, wellness 

7 and health promotion practices, the public health 

8 system, and integrative health care in the United 

9 States; 

10 (2) after obtaining input from relevant stake11 holders, develop a national prevention, health pro12 motion, public health, and integrative health care 

13 strategy that incorporates the most effective and 

14 achievable means of improving the health status of 

15 Americans and reducing the incidence of preventable 

16 illness and disability in the United States; 

17 (3) provide recommendations to the President 

18 and Congress concerning the most pressing health 

19 issues confronting the United States and changes in 

20 Federal policy to achieve national wellness, health 

21 promotion, and public health goals, including the re22 duction of tobacco use, sedentary behavior, and poor 

23 nutrition; 

24 (4) consider and propose evidence-based models, 

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1 motion of transformative models of prevention, inte2 grative health, and public health on individual and 

3 community levels across the United States; 

4 (5) establish processes for continual public 

5 input, including input from State, regional, and local 

6 leadership communities and other relevant stake7 holders, including Indian tribes and tribal organiza8 tions; 

9 (6) submit the reports required under sub10 section (g); and 

11 (7) carry out other activities determined appro12 priate by the President. 

13 (e) MEETINGS.—The Council shall meet at the call 

14 of the Chairperson. 

15 (f) NATIONAL PREVENTION AND HEALTH PRO16 MOTION STRATEGY.—Not later than 1 year after the date 

17 of enactment of this Act, the Chairperson, in consultation 

18 with the Council, shall develop and make public a national 

19 prevention, health promotion and public health strategy, 

20 and shall review and revise such strategy periodically. 

21 Such strategy shall— 

22 (1) set specific goals and objectives for improv23 ing the health of the United States through feder24 ally-supported prevention, health promotion, and 


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1 public health programs, consistent with ongoing goal 

2 setting efforts conducted by specific agencies; 

3 (2) establish specific and measurable actions 

4 and timelines to carry out the strategy, and deter5 mine accountability for meeting those timelines, 

6 within and across Federal departments and agencies; 

7 and 

8 (3) make recommendations to improve Federal 

9 efforts relating to prevention, health promotion, pub10 lic health, and integrative health care practices to 

11 ensure Federal efforts are consistent with available 

12 standards and evidence. 

13 (g) REPORT.—Not later than July 1, 2010, and an14 nually thereafter through January 1, 2015, the Council 

15 shall submit to the President and the relevant committees 

16 of Congress, a report that— 

17 (1) describes the activities and efforts on pre18 vention, health promotion, and public health and ac19 tivities to develop a national strategy conducted by 

20 the Council during the period for which the report 

21 is prepared; 

22 (2) describes the national progress in meeting 

23 specific prevention, health promotion, and public 

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1 cil and taken by relevant agencies and organizations 

2 to meet these goals; 

3 (3) contains a list of national priorities on 

4 health promotion and disease prevention to address 

5 lifestyle behavior modification (smoking cessation, 

6 proper nutrition, and appropriate exercise) and the 

7 prevention measures for the 5 leading disease killers 

8 in the United States; 

9 (4) contains specific science-based initiatives to 

10 achieve the measurable goals of Healthy People 

11 2010 regarding nutrition, exercise, and smoking ces12 sation, and targeting the 5 leading disease killers in 

13 the United States; 

14 (5) contains specific plans for consolidating 

15 Federal health programs and Centers that exist to 

16 promote healthy behavior and reduce disease risk 

17 (including eliminating programs and offices deter18 mined to be ineffective in meeting the priority goals 

19 of Healthy People 2010); 

20 (6) contains specific plans to ensure that all 

21 Federal health care programs are fully coordinated 

22 with science-based prevention recommendations by 

23 the Director of the Centers for Disease Control and 

24 Prevention; 


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1 (7) contains specific plans to ensure that all 

2 non-Department of Health and Human Services pre3 vention programs are based on the science-based 

4 guidelines developed by the Centers for Disease Con5 trol and Prevention under paragraph (4); and 

6 (8) contains a list of new non-Federal and non7 government partners identified by the council to 

8 build Federal capacity in health promotion and dis9 ease prevention efforts. 

10 (h) PERIODIC REVIEWS.—The Secretary and the 

11 Comptroller General of the United States shall jointly con12 duct periodic reviews, not less than every 5 years, and 

13 evaluations of every Federal disease prevention and health 

14 promotion initiative, program, and agency. Such reviews 

15 shall be evaluated based on effectiveness in meeting 

16 metrics-based goals with an analysis posted on such agen17 cies’ public Internet websites. 

18 (i) ANNUAL REQUEST TO GIVE TESTIMONY.—The 

19 Chairperson shall annually request an opportunity to tes20 tify before Congress concerning— 

21 (1) the progress made by the United States in 

22 meeting the prevention, health promotion, and public 

23 health goals defined in the strategy and the effec24 tiveness of Federal programs related to these goals; 

25 and 


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1 (2) the amount and sources of Federal funds 

2 that are targeted to prevention, health promotion, 

3 and public health initiatives and results of program 

4 evaluations. 

5 SEC. 302. PREVENTION AND PUBLIC HEALTH FUND. 

6 (a) PURPOSE.—It is the purpose of this section to 

7 establish a Prevention and Public Health Fund (referred 

8 to in this section as the ‘‘Fund’’), to be administered 

9 through the Department of Health and Human Services, 

10 Office of the Secretary, to provide for expanded and sus11 tained national investment in prevention and public health 

12 programs to improve health and help restrain the rate of 

13 growth in private and public sector health care costs. 

14 (b) FUNDING.—There are hereby authorized to be 

15 appropriated, and appropriated, to the Fund, out of any 

16 monies in the Treasury not otherwise appropriated— 

17 (1) for fiscal year 2010, $2,000,000,000; 

18 (2) for fiscal year 2011, $4,000,000,000; 

19 (3) for fiscal year 2012, $6,000,000,000; 

20 (4) for fiscal year 2013, $8,000,000,000; 

21 (5) for fiscal year 2014, $10,000,000,000; 

22 (6) for fiscal year 2015, $ 10,000,000,000; 

23 (7) for fiscal year 2016, $10,000,000,000; 

24 (8) for fiscal year 2017, $10,000,000,000; 

25 (9) for fiscal year 2018, $10,000,000,000; and 


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1 (10) for fiscal year 2019, and each fiscal year 

2 thereafter, $10,000,000,000. 

3 (c) USE OF FUND.—The Secretary shall transfer 

4 amounts in the Fund to accounts within the Department 

5 of Health and Human Services to increase funding, over 

6 the fiscal year 2008 level, for programs authorized by the 

7 Public Health Service Act, for prevention, wellness and 

8 public health activities including prevention research and 

9 health screenings. Such transfers shall be subject to the 

10 transfer authority provided for in the annual appropria11 tions Act for the fiscal year in which the funds become 

12 available. 

13 (d) TRANSFER AUTHORITY .—The Committee on Ap14 propriations of the Senate and the Committee on Appro15 priations of the House of Representatives may provide for 

16 the transfer of funds in the Fund to eligible activities 

17 under this section, subject to subsection (c). 

18 SEC. 303. CLINICAL AND COMMUNITY PREVENTIVE SERV19 ICES. 

20 (a) PREVENTIVE SERVICES TASK FORCE.—Section 

21 915 of the Public Health Service Act (42 U.S.C. 299b22 4) is amended by striking subsection (a) and inserting the 

23 following: 

24 ‘‘(a) PREVENTIVE SERVICES TASK FORCE.— 


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1 ‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di2 rector shall convene an independent Preventive Serv3 ices Task Force (referred to in this subsection as the 

4 ‘Task Force’) to be composed of individuals with ap5 propriate expertise. Such Task Force shall review 

6 the scientific evidence related to the effectiveness, 

7 appropriateness, and cost-effectiveness of clinical 

8 preventive services for the purpose of developing rec9 ommendations for the health care community, and 

10 updating previous clinical preventive recommenda11 tions, to be published in the Guide to Clinical Pre12 ventive Services (referred to in this section as the 

13 ‘Guide’), for individuals and organizations delivering 

14 clinical services, including primary care profes15 sionals, health care systems, professional societies, 

16 employers, community organizations, non-profit or17 ganizations, Congress and other policy-makers, gov18 ernmental public health agencies, health care quality 

19 organizations, and organizations developing national 

20 health objectives. Such recommendations shall con21 sider clinical preventive best practice recommenda22 tions from the Agency for Healthcare Research and 

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1 tute of Medicine, specialty medical associations, pa2 tient groups, and scientific societies. 

3 ‘‘(2) DUTIES.—The duties of the Task Force 

4 shall include— 

5 ‘‘(A) the development of additional topic 

6 areas for new recommendations and interven7 tions related to those topic areas, including 

8 those related to specific sub-populations and 

9 age groups; 

10 ‘‘(B) at least once during every 5-year pe11 riod, review interventions and update rec12 ommendations related to existing topic areas, 

13 including new or improved techniques to assess 

14 the health effects of interventions; 

15 ‘‘(C) improved integration with Federal 

16 Government health objectives and related target 

17 setting for health improvement; 

18 ‘‘(D) the enhanced dissemination of rec19 ommendations; 

20 ‘‘(E) the provision of technical assistance 

21 to those health care professionals, agencies and 

22 organizations that request help in implementing 

23 the Guide recommendations; and 

24 ‘‘(F) the submission of yearly reports to 

25 Congress and related agencies identifying gaps 


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1 in research, such as preventive services that re2 ceive an insufficient evidence statement, and 

3 recommending priority areas that deserve fur4 ther examination, including areas related to 

5 populations and age groups not adequately ad6 dressed by current recommendations. 

7 ‘‘(3) ROLE OF AGENCY.—The Agency shall pro8 vide ongoing administrative, research, and technical 

9 support for the operations of the Task Force, includ10 ing coordinating and supporting the dissemination of 

11 the recommendations of the Task Force, ensuring 

12 adequate staff resources, and assistance to those or13 ganizations requesting it for implementation of the 

14 Guide’s recommendations. 

15 ‘‘(4) COORDINATION WITH COMMUNITY PRE16 VENTIVE SERVICES TASK FORCE.—The Task Force 

17 shall take appropriate steps to coordinate its work 

18 with the Community Preventive Services Task Force 

19 and the Advisory Committee on Immunization Prac20 tices, including the examination of how each task 

21 force’s recommendations interact at the nexus of 

22 clinic and community. 

23 ‘‘(5) OPERATION.—Operation. In carrying out 

24 the duties under paragraph (2), the Task Force is 


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1 not subject to the provisions of Appendix 2 of title 

2 5, United States Code. 

3 ‘‘(6) INDEPENDENCE.—All members of the 

4 Task Force convened under this subsection, and any 

5 recommendations made by such members, shall be 

6 independent and, to the extent practicable, not sub7 ject to political pressure. 

8 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.— 

9 There are authorized to be appropriated such sums 

10 as may be necessary for each fiscal year to carry out 

11 the activities of the Task Force.’’. 

12 (b) COMMUNITY PREVENTIVE SERVICES TASK

13 FORCE.—Part P of title III of the Public Health Service 

14 Act is amended by adding at the end the following: 

15 ‘‘SEC. 399S. COMMUNITY PREVENTIVE SERVICES TASK 

16 FORCE. 

17 ‘‘(a) ESTABLISHMENT AND PURPOSE.—The Director 

18 of the Centers for Disease Control and Prevention shall 

19 convene an independent Community Preventive Services 

20 Task Force (referred to in this subsection as the ‘Task 

21 Force’) to be composed of individuals with appropriate ex22 pertise. Such Task Force shall review the scientific evi23 dence related to the effectiveness, appropriateness, and 

24 cost-effectiveness of community preventive interventions 

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1 lished in the Guide to Community Preventive Services (re2 ferred to in this section as the ‘Guide’), for individuals 

3 and organizations delivering population-based services, in4 cluding primary care professionals, health care systems, 

5 professional societies, employers, community organiza6 tions, non-profit organizations, schools, governmental pub7 lic health agencies, Indian tribes, tribal organizations and 

8 urban Indian organizations, medical groups, Congress and 

9 other policy-makers. Community preventive services in10 clude any policies, programs, processes or activities de11 signed to affect or otherwise affecting health at the popu12 lation level. 

13 ‘‘(b) DUTIES.—The duties of the Task Force shall 

14 include— 

15 ‘‘(1) the development of additional topic areas 

16 for new recommendations and interventions related 

17 to those topic areas, including those related to spe18 cific populations and age groups, as well as the so19 cial, economic and physical environments that can 

20 have broad effects on the health and disease of pop21 ulations and health disparities among sub-popu22 lations and age groups; 

23 ‘‘(2) at least once during every 5-year period, 

24 review interventions and update recommendations 

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1 proved techniques to assess the health effects of 

2 interventions, including health impact assessment 

3 and population health modeling; 

4 ‘‘(3) improved integration with Federal Govern5 ment health objectives and related target setting for 

6 health improvement; 

7 ‘‘(4) the enhanced dissemination of rec8 ommendations; 

9 ‘‘(5) the provision of technical assistance to 

10 those health care professionals, agencies, and organi11 zations that request help in implementing the Guide 

12 recommendations; and 

13 ‘‘(6) providing yearly reports to Congress and 

14 related agencies identifying gaps in research and 

15 recommending priority areas that deserve further ex16 amination, including areas related to populations 

17 and age groups not adequately addressed by current 

18 recommendations. 

19 ‘‘(c) ROLE OF AGENCY.—The Director shall provide 

20 ongoing administrative, research, and technical support 

21 for the operations of the Task Force, including coordi22 nating and supporting the dissemination of the rec23 ommendations of the Task Force, ensuring adequate staff 

24 resources, and assistance to those organizations request25 ing it for implementation of Guide recommendations. 


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1 ‘‘(d) COORDINATION WITH PREVENTIVE SERVICES

2 TASK FORCE.—The Task Force shall take appropriate 

3 steps to coordinate its work with the U.S. Preventive Serv4 ices Task Force and the Advisory Committee on Immuni5 zation Practices, including the examination of how each 

6 task force’s recommendations interact at the nexus of clin7 ic and community. 

8 ‘‘(e) OPERATION.—In carrying out the duties under 

9 subsection (b), the Task Force shall not be subject to the 

10 provisions of Appendix 2 of title 5, United States Code. 

11 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated such sums as may be 

13 necessary for each fiscal year to carry out the activities 

14 of the Task Force.’’. 

15 SEC. 304. EDUCATION AND OUTREACH CAMPAIGN REGARD16 ING PREVENTIVE BENEFITS. 

17 (a) IN GENERAL.—The Secretary of Health and 

18 Human Services (referred to in this section as the ‘‘Sec19 retary’’) shall provide for the planning and implementa20 tion of a national public–private partnership for a preven21 tion and health promotion outreach and education cam22 paign to raise public awareness of health improvement 

23 across the life span. Such campaign shall include the dis24 semination of information that— 


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1 (1) describes the importance of utilizing preven2 tive services to promote wellness, reduce health dis3 parities, and mitigate chronic disease; 

4 (2) promotes the use of preventive services rec5 ommended by the United States Preventive Services 

6 Task Force and the Community Preventive Services 

7 Task Force; 

8 (3) encourages healthy behaviors linked to the 

9 prevention of chronic diseases; 

10 (4) explains the preventive services covered 

11 under health plans offered through a Gateway; 

12 (5) describes additional preventive care sup13 ported by the Centers for Disease Control and Pre14 vention, the Health Resources and Services Adminis15 tration, the Substance Abuse and Mental Health 

16 Services Administration, the Advisory Committee on 

17 Immunization Practices, and other appropriate agen18 cies; and 

19 (6) includes general health promotion informa20 tion. 

21 (b) CONSULTATION.—In coordinating the campaign 

22 under subsection (a), the Secretary shall consult with the 

23 Institute of Medicine to provide ongoing advice on evi24 dence-based scientific information for policy, program de25 velopment, and evaluation. 


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1 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated such sums as may be 

3 necessary to carry out this section. 

4 Subtitle B—Increasing Access to 

5 Clinical Preventive Services 

6 SEC. 311. RIGHT CHOICES PROGRAM. 

7 (a) IN GENERAL.—Beginning on the date of enact8 ment of this Act, the Secretary shall award an annual 

9 grant to each State for the establishment of ‘‘Right 

10 Choices Programs’’. 

11 (b) ADMINISTRATION.—A State shall use amounts re12 ceived under a grant under subsection (a) to establish and 

13 implement a Right Choices Program. A State may admin14 ister the program through the State Medicaid program or 

15 through a comparable program. Under such program the 

16 State shall— 

17 (1) conduct outreach activities through State 

18 health and human services programs, through safety 

19 net facilities, or through other mechanisms deter20 mined appropriate by the State and the Secretary, 

21 to identify uninsured individuals; and 

22 (2) provide individuals identified under para23 graph (1), who are eligible individuals, with a Right 

24 Choices Card to be used to access the services de25 scribed in subsection (d). 


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1 (c) ELIGIBLE INDIVIDUALS.—To be eligible to par2 ticipate in a Right Choices program under this section, 

3 an individual shall— 

4 (1) be a citizen or national of the United States 

5 or an alien lawfully admitted to the United States 

6 for permanent residence or otherwise residing in the 

7 United States under color of law; 

8 (2) not be covered under any health insurance 

9 coverage during the 6-month period immediately 

10 preceding the date of the determination of eligibility; 

11 (3) have a family income that does not exceed 

12 350 percent of the Federal poverty level for a family 

13 of the size involved; and 

14 (4) not be eligible for health care benefits pro15 vided through Medicare, Medicaid, the State Chil16 dren’s Health Insurance Program, the armed serv17 ices, or the Department of Veterans Affairs. 

18 (d) SERVICES.—Services described in this subsection 

19 include the following: 

20 (1) RISK-STRATIFIED CARE PLAN.— 

21 (A) IN GENERAL.—An eligible individual 

22 participating in the Right Choices Program 

23 shall receive— 

24 (i) a one-time health risk appraisal; 

25 and 


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1 (ii) a risk-stratified care plan provided 

2 by a primary care professional who may be 

3 affiliated with the Medicare or Medicaid 

4 programs under title XVIII or XIX of the 

5 Social Security Act, or with a Federal or 

6 State safety net provider (such as a com7 munity care team, community health cen8 ter, or rural health clinic, as identified by 

9 the State). 

10 (B) REFERRALS.—A care plan under sub11 paragraph (A)— 

12 (i) shall include recommendations for 

13 behavioral changes, referrals to commu14 nity-based resources, and referrals for age 

15 and gender appropriate immunizations and 

16 screenings to prevent chronic diseases (as 

17 identified by the Secretary, in consultation 

18 with the Director of the Centers for Dis19 ease Control and Prevention, the Adminis20 trator of the Agency for Healthcare Re21 search and Quality, the Administrator of 

22 the Health Resources and Services Admin23 istration, the Administrator of the Sub24 stance Abuse and Mental Health Services 


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1 Administration, and other appropriate 

2 sources); and 

3 (ii) to the extent feasible, shall include 

4 referrals by the State of individuals to 

5 State and Federal programs for which they 

6 may be eligible. 

7 (2) TREATMENT.—An eligible individual partici8 pating in the Right Choices Program who has been 

9 diagnosed with an illnesses shall be referred for 

10 treatment to existing Federal or State safety net 

11 providers or facilities, as appropriate (such as public 

12 hospitals, community health centers, and rural 

13 health clinics). 

14 (e) PAYMENT OF PROVIDERS.— 

15 (1) IN GENERAL.—The State shall be required 

16 to reimburse health care providers that provide serv17 ices to individuals under the Right Choices Program. 

18 Such reimbursement shall be approved by the Sec19 retary and determined based on the amount paid by 

20 the State for similar services under the Medicaid 

21 program in the State. Such reimbursement shall not 

22 exceed the reimbursement provided for similar serv23 ices under the Medicare program. 

24 (2) COST SHARING.—A State shall require that 

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1 ceeds 200 percent of the Federal poverty level for a 

2 family of the size involved that is participating in 

3 the State’s Right Choices Program, contribute a 

4 portion of the cost of care under such Program on 

5 a sliding scale as determined by the Secretary. 

6 (f) AMOUNT OF GRANT.—The amount of a grant to 

7 a State under this section for a year shall be determined 

8 by the Secretary based on the rates of uninsured per cap9 ita of adults and children in the State (as compared to 

10 all States) and the prevalence of the most common costly 

11 chronic diseases in the State (as compared to all States). 

12 The Secretary shall determine what amount of the grant 

13 can be used for State administration of the program. The 

14 Secretary may also set aside not more than 20 percent 

15 of the funds appropriated to carry out this section to allo16 cate to programs that fund the treatment of individuals 

17 participating in a Right Choices Program. 

18 (g) PAYMENTS.—The Secretary shall determine the 

19 manner in which payments shall be made to States under 

20 this section on a prospective basis to enable the State to 

21 provide individuals with access to items and services until 

22 the Federal or State Gateways are available. 

23 (h) LIMITATION ON FUNDS.—The Secretary shall not 

24 obligate in excess of $5,000,000,000 for any fiscal year 

25 under this section. 


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1 (i) DEFINITION.—In this section, the term ‘‘State’’ 

2 means each of the several States, the District of Columbia, 

3 and each of the territories of the United States, and shall 

4 include Indian tribes and tribal organizations (as such 

5 terms are defined in section 4(b) and section 4(c) of the 

6 Indian Self-Determination and Education Assistance Act). 

7 (j) EVALUATION.—The Secretary shall conduct an 

8 annual evaluation of the effectiveness of the pilot program 

9 under this section. 

10 (k) LIMITATION.—Nothing in this title (or an amend11 ment made by this title) shall require that a State use 

12 State revenue to fund programs under this section. 

13 (l) SUNSET.—The program under this section shall 

14 terminate with respect to a State, on the date on which 

15 the Federal or State Gateways are available. 

16 SEC. 312. SCHOOL-BASED HEALTH CLINICS. 

17 Part Q of title III of the Public Health Service Act 

18 (42 U.S.C. 280h et seq.) is amended by adding at the end 

19 the following: 

20 ‘‘SEC. 399Z–1. SCHOOL-BASED HEALTH CLINICS. 

21 ‘‘(a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.— 

22 In this section: 

23 ‘‘(1) COMPREHENSIVE PRIMARY HEALTH SERV24 ICES.—The term ‘comprehensive primary health 

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1 based health clinics, which shall include the fol2 lowing: 

3 ‘‘(A) PHYSICAL.—Comprehensive health 

4 assessments, diagnosis, and treatment of minor, 

5 acute, and chronic medical conditions, and re6 ferrals to, and follow-up for, specialty care and 

7 oral health services. 

8 ‘‘(B) MENTAL HEALTH.—Mental health 

9 and substance use disorder assessments, crisis 

10 intervention, counseling, treatment, and referral 

11 to a continuum of services including emergency 

12 psychiatric care, community support programs, 

13 inpatient care, and outpatient programs. 

14 ‘‘(2) MEDICALLY UNDERSERVED CHILDREN

15 AND ADOLESCENTS.— 

16 ‘‘(A) IN GENERAL.—The term ‘medically 

17 underserved children and adolescents’ means a 

18 population of children and adolescents who are 

19 residents of an area designated as a medically 

20 underserved area or a health professional short21 age area by the Secretary. 

22 ‘‘(B) CRITERIA.—The Secretary shall pre23 scribe criteria for determining the specific 

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1 cally underserved children and adolescents 

2 under subparagraph (A) that shall— 

3 ‘‘(i) take into account any comments 

4 received by the Secretary from the chief 

5 executive officer of a State and local offi6 cials in a State; and 

7 ‘‘(ii) include factors indicative of the 

8 health status of such children and adoles9 cents of an area, including the ability of 

10 the residents of such area to pay for health 

11 services, the accessibility of such services, 

12 the availability of health professionals to 

13 such children and adolescents, and other 

14 factors as determined appropriate by the 

15 Secretary. 

16 ‘‘(3) SCHOOL-BASED HEALTH CLINIC.—The 

17 term ‘school-based health clinic’ means a health clin18 ic that— 

19 ‘‘(A) is located in or near a school facility 

20 of a school district or board; 

21 ‘‘(B) is organized through school, commu22 nity, and health provider relationships; 

23 ‘‘(C) is administered by a sponsoring facil24 ity; and 


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1 ‘‘(D) provides, at a minimum, comprehen2 sive primary health services during school hours 

3 to children and adolescents by health profes4 sionals in accordance with established stand5 ards, community practice, reporting laws, and 

6 other State laws, including parental consent 

7 and notification laws that are not inconsistent 

8 with Federal law. 

9 ‘‘(4) SPONSORING FACILITY.—The term ‘spon10 soring facility’ is a community-based organization, 

11 which may include— 

12 ‘‘(A) a hospital; 

13 ‘‘(B) a public health department; 

14 ‘‘(C) a community health center; 

15 ‘‘(D) a nonprofit health care agency; 

16 ‘‘(E) a local education agency; 

17 ‘‘(F) a faith-based organization; or 

18 ‘‘(G) any other entity determined appro19 priate by the Secretary. 

20 ‘‘(b) AUTHORITY TO AWARD GRANTS.—The Sec21 retary shall award grants for the costs of the operation 

22 of school-based health clinics (referred to in this section 

23 as ‘SBHCs’) that meet the requirements of this section. 

24 ‘‘(c) APPLICATIONS.—To be eligible to receive a grant 

25 under this section, an entity shall— 


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1 ‘‘(1) be an SBHC (as defined in subsection 

2 (a)(4)); and 

3 ‘‘(2) submit to the Secretary an application at 

4 such time, in such manner, and containing— 

5 ‘‘(A) evidence that the applicant meets all 

6 criteria necessary to be designated an SBHC; 

7 ‘‘(B) evidence of local need for the services 

8 to be provided by the SBHC; 

9 ‘‘(C) an assurance that— 

10 ‘‘(i) SBHC services will be provided to 

11 those children and adolescents for whom 

12 parental or guardian consent has been ob13 tained in cooperation with Federal, State, 

14 and local laws governing health care serv15 ice provision to children and adolescents; 

16 ‘‘(ii) the SBHC has made and will 

17 continue to make every reasonable effort to 

18 establish and maintain collaborative rela19 tionships with other health care providers 

20 in the catchment area of the SBHC; 

21 ‘‘(iii) the SBHC will provide on-site 

22 access during the academic day when 

23 school is in session and 24-hour coverage 

24 through an on-call system and through its 

25 backup health providers to ensure access to 


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1 services on a year-round basis when the 

2 school or the SBHC is closed; 

3 ‘‘(iv) the SBHC will be integrated into 

4 the school environment and will coordinate 

5 health services with school personnel, such 

6 as administrators, teachers, nurses, coun7 selors, and support personnel, as well as 

8 with other community providers co-located 

9 at the school; 

10 ‘‘(v) the SBHC sponsoring facility as11 sumes all responsibility for the SBHC ad12 ministration, operations, and oversight; 

13 and 

14 ‘‘(vi) the SBHC will comply with Fed15 eral, State, and local laws concerning pa16 tient privacy and student records, includ17 ing regulations promulgated under the 

18 Health Insurance Portability and Account19 ability Act of 1996 and section 444 of the 

20 General Education Provisions Act; and 

21 ‘‘(D) such other information as the Sec22 retary may require. 

23 ‘‘(d) PREFERENCES.—In reviewing applications, the 

24 Secretary may give preference to applicants who dem25 onstrate an ability to serve the following: 


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1 ‘‘(1) Communities that have evidenced barriers 

2 to primary health care and mental health and sub3 stance use disorder prevention services for children 

4 and adolescents. 

5 ‘‘(2) Communities with high per capita numbers 

6 of children and adolescents who are uninsured, 

7 underinsured, or enrolled in public health insurance 

8 programs. 

9 ‘‘(3) Populations of children and adolescents 

10 that have historically demonstrated difficulty in ac11 cessing health and mental health and substance use 

12 disorder prevention services. 

13 ‘‘(e) WAIVER OF REQUIREMENTS.—The Secretary 

14 may— 

15 ‘‘(1) under appropriate circumstances, waive 

16 the application of all or part of the requirements of 

17 this subsection with respect to an SBHC for not to 

18 exceed 2 years; and 

19 ‘‘(2) upon a showing of good cause, waive the 

20 requirement that the SBHC provide all required 

21 comprehensive primary health services for a des22 ignated period of time to be determined by the Sec23 retary. 

24 ‘‘(f) USE OF FUNDS.— 


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1 ‘‘(1) FUNDS.—Funds awarded under a grant 

2 under this section may be used for 

3 ‘‘(A) acquiring and leasing equipment (in4 cluding the costs of amortizing the principle of, 

5 and paying interest on, loans for such equip6 ment); 

7 ‘‘(B) providing training related to the pro8 vision of required comprehensive primary health 

9 services and additional health services; 

10 ‘‘(C) the management and operation of 

11 health center programs; and 

12 ‘‘(D) the payment of salaries for physi13 cians, nurses, and other personnel of the 

14 SBHC. 

15 ‘‘(2) CONSTRUCTION.—The Secretary may 

16 award grants which may be used to pay the costs as17 sociated with expanding and modernizing existing 

18 buildings for use as an SBHC, including the pur19 chase of trailers or manufactured buildings to install 

20 on the school property. 

21 ‘‘(3) AMOUNT.—The amount of any grant made 

22 in any fiscal year to an SBHC shall be determined 

23 by the Secretary, taking into account— 

24 ‘‘(A) the financial need of the SBHC; 


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1 ‘‘(B) State, local, or other operation fund2 ing provided to the SBHC; and 

3 ‘‘(C) other factors as determined appro4 priate by the Secretary. 

5 ‘‘(4) LIMITATION.—Any provider of services 

6 that is determined by a State to be in violation of 

7 a State law described in subsection (a)(4)(D) with 

8 respect to activities carried out at a SBHC shall not 

9 be eligible to receive additional funding under this 

10 section. 

11 ‘‘(g) MATCHING REQUIREMENT.— 

12 ‘‘(1) IN GENERAL.—Each eligible entity that re13 ceives a grant under this section shall provide, from 

14 non-Federal sources, an amount equal to 20 percent 

15 of the amount of the grant (which may be provided 

16 in cash or in-kind) to carry out the activities sup17 ported by the grant. 

18 ‘‘(2) WAIVER.—The Secretary may waive all or 

19 part of the matching requirement described in para20 graph (1) for any fiscal year for the SBHC if the 

21 Secretary determines that applying the matching re22 quirement to the SBHC would result in serious 

23 hardship or an inability to carry out the purposes of 

24 this section. 


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1 ‘‘(h) SUPPLEMENT, NOT SUPPLANT.—Grant funds 

2 provided under this section shall be used to supplement, 

3 not supplant, other Federal or State funds. 

4 ‘‘(i) TECHNICAL ASSISTANCE.—The Secretary shall 

5 establish a program through which the Secretary shall 

6 provide (either through the Department of Health and 

7 Human Services or by grant or contract) technical and 

8 other assistance to SBHCs to assist such SBHCs to meet 

9 the requirements of subsection (c)(2)(C). Services pro10 vided through the program may include necessary tech11 nical and nonfinancial assistance, including fiscal and pro12 gram management assistance, training in fiscal and pro13 gram management, operational and administrative sup14 port, and the provision of information to the entities of 

15 the variety of resources available under this title and how 

16 those resources can be best used to meet the health needs 

17 of the communities served by the entities. 

18 ‘‘(j) EVALUATION.—The Secretary shall develop and 

19 implement a plan for evaluating SBHCs and monitoring 

20 quality performance under the awards made under this 

21 section. 

22 ‘‘(k) AGE APPROPRIATE SERVICES.—An eligible enti23 ty receiving funds under this section shall only provide age 

24 appropriate services through a SBHC funded under this 

25 section to an individual. 


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1 ‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—For 

2 purposes of carrying out this section, there are authorized 

3 to be appropriated such sums as may be necessary for 

4 each of the fiscal years 2010 through 2014.’’. 

5 SEC. 313. ORAL HEALTHCARE PREVENTION ACTIVITIES. 

6 (a) IN GENERAL.—Title III of the Public Health 

7 Service Act (42 U.S.C. 241 et seq.) is amended by adding 

8 at the end the following: 

9 ‘‘PART S—ORAL HEALTHCARE PREVENTION 

10 ACTIVITIES 

11 ‘‘SEC. 399GG. ORAL HEALTHCARE PREVENTION EDUCATION 

12 CAMPAIGN. 

13 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

14 through the Director of the Centers for Disease Control 

15 and Prevention and in consultation with professional oral 

16 health organizations, shall, subject to the availability of 

17 appropriations, establish a 5-year national, public edu18 cation campaign (referred to in this section as the ‘cam19 paign’) that is focused on oral healthcare prevention and 

20 education, including prevention of oral disease such as 

21 early childhood and other caries, periodontal disease, and 

22 oral cancer. 

23 ‘‘(b) REQUIREMENTS.—In establishing the campaign, 

24 the Secretary shall— 


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1 ‘‘(1) ensure that activities are targeted towards 

2 specific populations such as children, pregnant 

3 women, parents, the elderly, individuals with disabil4 ities, and ethnic and racial minority populations, in5 cluding Indians, Alaska Natives and Native Hawai6 ians (as defined in section 4(c) of the Indian Health 

7 Care Improvement Act) in a culturally and linguis8 tically appropriate manner; and 

9 ‘‘(2) utilize science-based strategies to convey 

10 oral health prevention messages that include, but are 

11 not limited to, community water fluoridation and 

12 dental sealants. 

13 ‘‘(c) PLANNING AND IMPLEMENTATION.—Not later 

14 than 2 years after the date of enactment of this section, 

15 the Secretary shall begin implementing the 5-year cam16 paign. During the 2-year period referred to in the previous 

17 sentence, the Secretary shall conduct planning activities 

18 with respect to the campaign. 

19 ‘‘SEC. 399GG-1. RESEARCH-BASED DENTAL CARIES DISEASE 

20 MANAGEMENT. 

21 ‘‘(a) IN GENERAL.—The Secretary, acting through 

22 the Director of the Centers for Disease Control and Pre23 vention, shall award demonstration grants to eligible enti24 ties to demonstrate the effectiveness of research-based 

25 dental caries disease management activities. 


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1 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

2 this section, an entity shall— 

3 ‘‘(1) be a community-based provider of dental 

4 services (as defined by the Secretary), including a 

5 Federally-qualified health center, a clinic of a hos6 pital owned or operated by a State (or by an instru7 mentality or a unit of government within a State), 

8 a State or local department of health, a dental pro9 gram of the Indian Health Service, an Indian tribe 

10 or tribal organization, or an urban Indian organiza11 tion (as such terms are defined in section 4 of the 

12 Indian Health Care Improvement Act), a health sys13 tem provider, a private provider of dental services, 

14 medical, dental, public health, nursing, nutrition 

15 educational institutions, or national organizations in16 volved in improving children’s oral health; and 

17 ‘‘(2) submit to the Secretary an application at 

18 such time, in such manner, and containing such in19 formation as the Secretary may require. 

20 ‘‘(c) USE OF FUNDS.—A grantee shall use amounts 

21 received under a grant under this section to demonstrate 

22 the effectiveness of research-based dental caries disease 

23 management activities. 

24 ‘‘(d) USE OF INFORMATION.—The Secretary shall 

25 utilize information generated from grantees under this 


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1 section in planning and implementing the public education 

2 campaign under section 399GG. 

3 ‘‘SEC. 399GG-2. AUTHORIZATION OF APPROPRIATIONS. 

4 ‘‘There is authorized to be appropriated to carry out 

5 this part, such sums as may be necessary.’’. 

6 SEC. 314. ORAL HEALTH IMPROVEMENT. 

7 (a) SCHOOL-BASED SEALANT PROGRAMS.—Section 

8 317M(c)(1) of the Public Health Service Act (42 U.S.C. 

9 247b-14(c)(1)) is amended by striking ‘‘may award grants 

10 to States and Indian tribes’’ and inserting ‘‘shall award 

11 a grant to each of the 50 States and territories and to 

12 Indians, Indian tribes, tribal organizations and urban In13 dian organizations (as such terms are defined in section 

14 4 of the Indian Health Care Improvement Act)’’. 

15 (b) ORAL HEALTH INFRASTRUCTURE.—Section 

16 317M of the Public Health Service Act (42 U.S.C. 247b17 14) is amended— 

18 (1) by redesignating subsections (d) and (e) as 

19 subsections (e) and (f), respectively; and 

20 (2) by inserting after subsection (c), the fol21 lowing: 

22 ‘‘(d) ORAL HEALTH INFRASTRUCTURE.— 

23 ‘‘(1) COOPERATIVE AGREEMENTS.—The Sec24 retary, acting through the Director of the Centers 

25 for Disease Control and Prevention, shall enter into 


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1 cooperative agreements with State, territorial, and 

2 Indian tribes or tribal organizations (as those terms 

3 are defined in section 4 of the Indian Health Care 

4 Improvement Act) to establish oral health leadership 

5 and program guidance, oral health data collection 

6 and interpretation, (including determinants of poor 

7 oral health among vulnerable populations), a multi8 dimensional delivery system for oral health, and to 

9 implement science-based programs (including dental 

10 sealants and community water fluoridation) to im11 prove oral health. 

12 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

13 There is authorized to be appropriated such sums as 

14 necessary to carry out this subsection for fiscal years 

15 2010 through 2014.’’. 

16 (c) UPDATING NATIONAL ORAL HEALTHCARE SUR17 VEILLANCE ACTIVITIES.— 

18 (1) PRAMS.— 

19 (A) IN GENERAL.—The Secretary of 

20 Health and Human Services (referred to in this 

21 subsection as the ‘‘Secretary’’) shall carry out 

22 activities to update and improve the Pregnancy 

23 Risk Assessment Monitoring System (referred 

24 to in this section as ‘‘PRAMS’’) as it relates to 

25 oral healthcare. 


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1 (B) STATE REPORTS AND MANDATORY

2 MEASUREMENTS.— 

3 (i) IN GENERAL.—Not later than 5 

4 years after the date of enactment of this 

5 Act, and every 5 years thereafter, a State 

6 shall submit to the Secretary a report con7 cerning activities conducted within the 

8 State under PRAMS. 

9 (ii) MEASUREMENTS.—The oral 

10 healthcare measurements developed by the 

11 Secretary for use under PRAMS shall be 

12 mandatory with respect to States for pur13 poses of the State reports under clause (i). 

14 (C) FUNDING.—There is authorized to be 

15 appropriated to carry out this paragraph, such 

16 sums as may be necessary. 

17 (2) NATIONAL HEALTH AND NUTRITION EXAM18 INATION SURVEY.—The Secretary shall develop oral 

19 healthcare components that shall include tooth-level 

20 surveillance for inclusion in the National Health and 

21 Nutrition Examination Survey. Such components 

22 shall be updated by the Secretary at least every 6 

23 years. For purposes of this paragraph, the term 

24 ‘‘tooth-level surveillance’’ means a clinical examina25 tion where an examiner looks at each dental surface, 


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1 on each tooth in the mouth and as expanded by the 

2 Division of Oral Health of the Centers for Disease 

3 Control and Prevention. 

4 (3) MEDICAL EXPENDITURES PANEL SURVEY.— 

5 The Secretary shall ensure that the Medical Expend6 itures Panel Survey by the Agency for Healthcare 

7 Research and Quality includes the verification of 

8 dental utilization, expenditure, and coverage findings 

9 through conduct of a look-back analysis. 

10 (4) NATIONAL ORAL HEALTH SURVEILLANCE

11 SYSTEM.— 

12 (A) APPROPRIATIONS.—There is author13 ized to be appropriated, such sums as may be 

14 necessary for each of fiscal years 2010 through 

15 2014 to increase the participation of States in 

16 the National Oral Health Surveillance System 

17 from 16 States to all 50 States, territories, and 

18 District of Columbia. 

19 (B) REQUIREMENTS.—The Secretary shall 

20 ensure that the National Oral Health Surveil21 lance System include the measurement of early 

22 childhood caries. 


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1 Subtitle C—Creating Healthier 

2 Communities 

3 SEC. 321. COMMUNITY TRANSFORMATION GRANTS. 

4 (a) IN GENERAL.—The Secretary of Health and 

5 Human Services (referred to in this section as the ‘‘Sec6 retary’’), acting through the Director of the Centers for 

7 Disease Control and Prevention (referred to in this section 

8 as the ‘‘Director’’), shall award competitive grants to 

9 State and local governmental agencies and community10 based organizations for the implementation, evaluation, 

11 and dissemination of evidence-based community preventive 

12 health activities in order to reduce chronic disease rates, 

13 address health disparities, and develop a stronger evi14 dence-base of effective prevention programming. 

15 (b) ELIGIBILITY.—To be eligible to receive a grant 

16 under subsection (a), an entity shall— 

17 (1) be a— 

18 (A) State governmental agency; 

19 (B) local governmental agency; 

20 (C) national network of community-based 

21 organizations; or 

22 (D) Indian tribe; and 

23 (2) submit to the Director an application at 

24 such time, in such a manner, and containing such 

25 information as the Director may require, including a 


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1 description of the program to be carried out under 

2 the grant; and 

3 (3) demonstrate a history or capacity, if fund4 ed, to develop relationships necessary to engage key 

5 stakeholders from multiple sectors across a commu6 nity, such as healthy futures corps. 

7 (c) USE OF FUNDS.— 

8 (1) IN GENERAL.—An eligible entity shall use 

9 amounts received under a grant under this section to 

10 carry out programs described in this subsection. 

11 (2) COMMUNITY TRANSFORMATION PLAN.— 

12 (A) IN GENERAL.—An eligible entity that 

13 receives a grant under this section shall submit 

14 to the Director (for approval) a detailed plan 

15 that includes the policy, environmental, pro16 grammatic, and as appropriate infrastructure 

17 changes needed to promote healthy living and 

18 reduce disparities. 

19 (B) ACTIVITIES.—Activities within the 

20 plan may focus on (but not be limited to)— 

21 (i) creating healthier school environ22 ments, including increasing healthy food 

23 options, physical activity opportunities, 

24 promotion of healthy lifestyle and prevenVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00491 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 tion curricula, and activities to prevent 

2 chronic diseases; 

3 (ii) creating the infrastructure to sup4 port active living and access to nutritious 

5 foods in a safe environment; 

6 (iii) developing and promoting pro7 grams targeting a variety of age levels to 

8 increase access to nutrition, physical activ9 ity and smoking cessation, enhance safety 

10 in a community, or address any other 

11 chronic disease priority area identified by 

12 the grantee; 

13 (iv) assessing and implementing work14 site wellness programming and incentives; 

15 (v) working to highlight healthy op16 tions at restaurants and other food venues; 

17 (vi) prioritizing strategies to reduce 

18 racial and ethnic disparities, including so19 cial determinants of health; and 

20 (vii) addressing the needs of special 

21 populations, including all age groups and 

22 individuals with disabilities. 

23 (3) COMMUNITY-BASED PREVENTION HEALTH

24 ACTIVITIES.— 


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1 (A) IN GENERAL.—An eligible entity shall 

2 use amounts received under a grant under this 

3 section to implement a variety of programs, 

4 policies, and infrastructure improvements to 

5 promote healthier lifestyles. 

6 (B) ACTIVITIES.—An eligible entity shall 

7 implement activities detailed in the community 

8 transformation plan under paragraph (2). 

9 (C) IN-KIND SUPPORT.—An eligible entity 

10 shall provide in-kind resources such as staff, 

11 equipment, or office space in carrying out ac12 tivities under this section. 

13 (4) EVALUATION.— 

14 (A) IN GENERAL.—An eligible entity shall 

15 use amounts provided under a grant under this 

16 section to conduct activities to measure changes 

17 in the prevalence of chronic disease risk factors 

18 among community members participating in 

19 preventive health activities 

20 (B) TYPES OF MEASURES.—In carrying 

21 out subparagraph (A), the eligible entity shall, 

22 with respect to residents in the community, 

23 measure— 

24 (i) changes in weight; 

25 (ii) changes in proper nutrition; 


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1 (iii) changes in physical activity; 

2 (iv) changes in tobacco use prevalence; 

3 (v) other factors using community4 specific data from the Behavioral Risk 

5 Factor Surveillance Survey; and 

6 (vi) other factors as determined by the 

7 Secretary. 

8 (C) REPORTING.—An eligible entity shall 

9 annually submit to the Director a report con10 taining an evaluation of activities carried out 

11 under the grant. 

12 (5) DISSEMINATION.—A grantee under this sec13 tion shall— 

14 (A) meet at least annually in regional or 

15 national meetings to discuss challenges, best 

16 practices, and lessons learned with respect to 

17 activities carried out under the grant; and 

18 (B) develop models for the replication of 

19 successful programs and activities and the men20 toring of other eligible entities. 

21 (d) TRAINING.— 

22 (1) IN GENERAL.—The Director shall develop a 

23 program to provide training for eligible entities on 

24 effective strategies for the prevention and control of 

25 chronic disease 


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1 (2) COMMUNITY TRANSFORMATION PLAN.—The 

2 Director shall provide appropriate feedback and 

3 technical assistance to grantees to establish commu4 nity transformation plans 

5 (3) EVALUATION.—The Director shall provide a 

6 literature review and framework for the evaluation 

7 of programs conducted as part of the grant program 

8 under this section, in addition to working with aca9 demic institutions or other entities with expertise in 

10 outcome evaluation. 

11 (e) PROHIBITION.—A grantee shall not use funds 

12 provided under a grant under this section to create video 

13 games or to carry out any other activities that may lead 

14 to higher rates of obesity or inactivity. 

15 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

16 are authorized to be appropriated to carry out this section, 

17 such sums as may be necessary for each fiscal years 2010 

18 through 2014. 

19 SEC. 322. HEALTHY AGING, LIVING WELL. 

20 (a) IN GENERAL.—The Secretary of Health and 

21 Human Services (referred to in this section as the ‘‘Sec22 retary’’), acting through the Director of the Centers for 

23 Disease Control and Prevention, shall award grants to 

24 State or local health departments and Indian tribes to 

25 carry out 5-year pilot programs to provide public health 


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1 community interventions, screenings, and where nec2 essary, clinical referrals for individuals who are between 

3 55 and 64 years of age. 

4 (b) ELIGIBILITY.—To be eligible to receive a grant 

5 under subsection (a), an entity shall— 

6 (1) be— 

7 (A) a State health department; 

8 (B) a local health department; or 

9 (C) an Indian tribe; 

10 (2) submit to the Secretary an application at 

11 such time, in such manner, and containing such in12 formation as the Secretary may require including a 

13 description of the program to be carried out under 

14 the grant; 

15 (3) design a strategy for improving the health 

16 of the 55-to-64 year-old population through commu17 nity-based public health interventions; and 

18 (4) demonstrate the capacity, if funded, to de19 velop the relationships necessary with relevant health 

20 agencies, health care providers, community-based or21 ganizations, and insurers to carry out the activities 

22 described in subsection (c), such relationships to in23 clude the identification of a community-based clinical 

24 partner, such as a community health center or rural 

25 health clinic. 


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1 (c) USE OF FUNDS.— 

2 (1) IN GENERAL.—A State or local health de3 partment shall use amounts received under a grant 

4 under this section to carry out a program to provide 

5 the services described in this subsection to individ6 uals who are between 55 and 64 years of age. 

7 (2) PUBLIC HEALTH INTERVENTIONS.— 

8 (A) IN GENERAL.—In developing and im9 plementing such activities, a grantee shall col10 laborate with the Centers for Disease Control 

11 and Prevention and the Administration on 

12 Aging, and relevant local agencies and organi13 zations. 

14 (B) TYPES OF INTERVENTION ACTIVI15 TIES.—Intervention activities conducted under 

16 this paragraph may include efforts to improve 

17 nutrition, increase physical activity, reduce to18 bacco use and substance abuse, improve mental 

19 health, and promote healthy lifestyles among 

20 the target population. 

21 (3) COMMUNITY PREVENTIVE SCREENINGS.— 

22 (A) IN GENERAL.—In addition to commu23 nity-wide public health interventions, a State or 

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1 duct ongoing health screening to identify risk 

2 factors for cardiovascular disease, stroke, and 

3 diabetes among individuals who are between 55 

4 and 64 years of age. 

5 (B) TYPES OF SCREENING ACTIVITIES.— 

6 Screening activities conducted under this para7 graph may include— 

8 (i) mental health/behavioral health 

9 and substance use disorders; 

10 (ii) physical activity, smoking, and nu11 trition; and 

12 (iii) any other measures deemed ap13 propriate by the Secretary. 

14 (C) MONITORING.—Grantees under this 

15 section shall maintain records of screening re16 sults under this paragraph to establish the 

17 baseline data for monitoring the targeted popu18 lation 

19 (4) CLINICAL REFERRAL/TREATMENT FOR

20 CHRONIC DISEASES.— 

21 (A) IN GENERAL.—A State or local health 

22 department shall use amounts received under a 

23 grant under this section to ensure that individ24 uals between 55 and 64 years of age who are 

25 found to have chronic disease risk factors 


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1 through the screening activities described in 

2 paragraph (3)(B), receive clinical referral/treat3 ment for follow-up services to reduce such risk. 

4 (B) MECHANISM.— 

5 (i) IDENTIFICATION AND DETERMINA6 TION OF STATUS.—With respect to each 

7 individual with risk factors for or having 

8 heart disease, stroke, diabetes, or any 

9 other condition for which such individual 

10 was screened under paragraph (3), a 

11 grantee under this section shall determine 

12 whether or not such individual is covered 

13 under any public or private health insur14 ance program. 

15 (ii) INSURED INDIVIDUALS.—An indi16 vidual determined to be covered under a 

17 health insurance program under clause (i) 

18 shall be referred by the grantee to the ex19 isting providers under such program or, if 

20 such individual does not have a current 

21 provider, to a provider who is in-network 

22 with respect to the program involved. 

23 (iii) UNINSURED INDIVIDUALS.—With 

24 respect to an individual determined to be 

25 uninsured under clause (i), the grantee’s 


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1 community-based clinical partner described 

2 in subsection (b)(4) shall assist the indi3 vidual in determining eligibility for avail4 able public coverage options and identify 

5 other appropriate community health care 

6 resources and assistance programs. 

7 (C) PUBLIC HEALTH INTERVENTION PRO8 GRAM.—A State or local health department 

9 shall use amounts received under a grant under 

10 this section to enter into contracts with commu11 nity health centers or rural health clinics and 

12 mental health and substance use disorder serv13 ice providers to assist in the referral/treatment 

14 of at risk patients to community resources for 

15 clinical follow-up and help determine eligibility 

16 for other public programs. 

17 (5) GRANTEE EVALUATION.—An eligible entity 

18 shall use amounts provided under a grant under this 

19 section to conduct activities to measure changes in 

20 the prevalence of chronic disease risk factors among 

21 participants. 

22 (d) PILOT PROGRAM EVALUATION.—The Secretary 

23 shall conduct an annual evaluation of the effectiveness of 

24 the pilot program under this section. In determining such 

25 effectiveness, the Secretary shall consider changes in the 


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1 prevalence of uncontrolled chronic disease risk factors 

2 among new Medicare enrollees (or individuals nearing en3 rollment, including those who are 63 and 64 years of age) 

4 who reside in States or localities receiving grants under 

5 this section as compared with national and historical data 

6 for those States and localities for the same population. 

7 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated to carry out this section, 

9 such sums as may be necessary for each of fiscal years 

10 2010 through 2014. 

11 SEC. 323. WELLNESS FOR INDIVIDUALS WITH DISABILITIES. 

12 Title V of the Rehabilitation Act of 1973 (29 U.S.C. 

13 791 et seq.) is amended by adding at the end of the fol14 lowing: 

15 ‘‘SEC. 510. ESTABLISHMENT OF STANDARDS FOR ACCES16 SIBLE MEDICAL DIAGNOSTIC EQUIPMENT. 

17 ‘‘(a) STANDARDS.—Not later than 24 months after 

18 the date of enactment of the Affordable Health Choices 

19 Act, the Architectural and Transportation Barriers Com20 pliance Board shall, in consultation with the Commis21 sioner of the Food and Drug Administration, promulgate 

22 regulatory standards in accordance with the Administra23 tive Procedure Act (2 U.S.C. 551 et seq.) setting forth 

24 the minimum technical criteria for medical diagnostic 

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1 fices, clinics, emergency rooms, hospitals, and other med2 ical settings. The standards shall ensure that such equip3 ment is accessible to, and usable by, individuals with ac4 cessibility needs, and shall allow independent entry to, use 

5 of, and exit from the equipment by such individuals to the 

6 maximum extent possible. 

7 ‘‘(b) MEDICAL DIAGNOSTIC EQUIPMENT COV8 ERED.—The standards issued under subsection (a) for 

9 medical diagnostic equipment shall apply to equipment 

10 that includes examination tables, examination chairs (in11 cluding chairs used for eye examinations or procedures, 

12 and dental examinations or procedures), weight scales, 

13 mammography equipment, x-ray machines, and other radi14 ological equipment commonly used for diagnostic purposes 

15 by health professionals. 

16 ‘‘(c) REVIEW AND AMENDMENT.—The Architectural 

17 and Transportation Barriers Compliance Board, in con18 sultation with the Commissioner of the Food and Drug 

19 Administration, shall periodically review and, as appro20 priate, amend the standards in accordance with the Ad21 ministrative Procedure Act (2 U.S.C. 551 et seq.).’’. 

22 SEC. 324. IMMUNIZATIONS. 

23 (a) STATE AUTHORITY TO PURCHASE REC24 OMMENDED VACCINES FOR ADULTS.—Section 317 of the 


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1 Public Health Service Act (42 U.S.C. 247b) is amended 

2 by adding at the end the following: 

3 ‘‘(l) AUTHORITY TO PURCHASE RECOMMENDED VAC4 CINES FOR ADULTS.— 

5 ‘‘(1) IN GENERAL.—The Secretary may nego6 tiate and enter into contracts with manufacturers of 

7 vaccines for the purchase and delivery of vaccines 

8 for adults as provided for under subsection (e). 

9 ‘‘(2) STATE PURCHASE.—A State may obtain 

10 additional quantities of such adult vaccines (subject 

11 to amounts specified to the Secretary by the State 

12 in advance of negotiations) through the purchase of 

13 vaccines from manufacturers at the applicable price 

14 negotiated by the Secretary under this subsection.’’. 

15 (b) DEMONSTRATION PROGRAM TO IMPROVE IMMU16 NIZATION COVERAGE.—Section 317 of the Public Health 

17 Service Act (42 U.S.C. 247b), as amended by subsection 

18 (a), is further amended by adding at the end the following: 

19 ‘‘(m) DEMONSTRATION PROGRAM TO IMPROVE IM20 MUNIZATION COVERAGE.— 

21 ‘‘(1) IN GENERAL.—The Secretary, acting 

22 through the Director of the Centers for Disease 

23 Control and Prevention, shall establish a demonstra24 tion program to award grants to States to improve 

25 the provision of recommended immunizations for 


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1 children, adolescents, and adults through the use of 

2 evidence-based, population-based interventions for 

3 high-risk populations. 

4 ‘‘(2) STATE PLAN.—To be eligible for a grant 

5 under paragraph (1), a State shall submit to the 

6 Secretary an application at such time, in such man7 ner, and containing such information as the Sec8 retary may require, including a State plan that de9 scribes the interventions to be implemented under 

10 the grant and how such interventions match with 

11 local needs and capabilities, as determined through 

12 consultation with local authorities. 

13 ‘‘(3) USE OF FUNDS.—Funds received under a 

14 grant under this subsection shall be used to imple15 ment interventions that are recommended by the 

16 Task Force on Community Preventive Services (as 

17 established by the Secretary, acting through the Di18 rector of the Centers for Disease Control and Pre19 vention) or other evidence-based interventions, in20 cluding— 

21 ‘‘(A) providing immunization reminders or 

22 recalls for target populations of clients, pa23 tients, and consumers; 

24 ‘‘(B) educating targeted populations and 

25 health care providers concerning immunizations 


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1 in combination with one or more other interven2 tions; 

3 ‘‘(C) reducing out-of-pocket costs for fami4 lies for vaccines and their administration; 

5 ‘‘(D) carrying out immunization-promoting 

6 strategies for participants or clients of public 

7 programs, including assessments of immuniza8 tion status, referrals to health care providers, 

9 education, provision of on-site immunizations, 

10 or incentives for immunization; 

11 ‘‘(E) providing for home visits that pro12 mote immunization through education, assess13 ments of need, referrals, provision of immuniza14 tions, or other services; 

15 ‘‘(F) providing reminders or recalls for im16 munization providers; 

17 ‘‘(G) conducting assessments of, and pro18 viding feedback to, immunization providers; 

19 ‘‘(H) any combination of one or more 

20 interventions described in this paragraph; or 

21 ‘‘(I) immunization information systems to 

22 allow all States to have electronic databases for 

23 immunization records. 

24 ‘‘(4) CONSIDERATION.—In awarding grants 

25 under this subsection, the Secretary shall consider 


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1 any reviews or recommendations of the Task Force 

2 on Community Preventive Services. 

3 ‘‘(5) EVALUATION.—Not later than 3 years 

4 after the date on which a State receives a grant 

5 under this subsection, the State shall submit to the 

6 Secretary an evaluation of progress made toward im7 proving immunization coverage rates among high8 risk populations within the State. 

9 ‘‘(6) REPORT TO CONGRESS.—Not later than 4 

10 years after the date of enactment of the Affordable 

11 Health Choices Act, the Secretary shall submit to 

12 Congress a report concerning the effectiveness of the 

13 demonstration program established under this sub14 section together with recommendations on whether 

15 to continue and expand such program. 

16 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.— 

17 There is authorized to be appropriated to carry out 

18 this subsection, such sums as may be necessary for 

19 each of fiscal years 2010 through 2014.’’. 

20 (c) REAUTHORIZATION OF IMMUNIZATION PRO21 GRAM.—Section 317(j) of the Public Health Service Act 

22 (42 U.S.C. 247b(j)) is amended— 

23 (1) in paragraph (1), by striking ‘‘for each of 

24 the fiscal years 1998 through 2005’’; and 


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1 (2) in paragraph (2), by striking ‘‘after October 

2 1, 1997,’’. 

3 (d) RULE OF CONSTRUCTION REGARDING ACCESS TO

4 IMMUNIZATIONS.—Nothing in this section (including the 

5 amendments made by this section), or any other provision 

6 of this Act (including any amendments made by this Act) 

7 shall be construed to decrease children’s access to immuni8 zations. 

9 SEC. 325. NUTRITION LABELING OF STANDARD MENU 

10 ITEMS AT CHAIN RESTAURANTS AND OF AR11 TICLES OF FOOD SOLD FROM VENDING MA12 CHINES. 

13 (a) TECHNICAL AMENDMENTS.—Section 

14 403(q)(5)(A) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 343(q)(5)(A)) is amended— 

16 (1) in subitem (i), by inserting at the beginning 

17 ‘‘except as provided in clause (H)(ii)(III),’’; and 

18 (2) in subitem (ii), by inserting at the begin19 ning ‘‘except as provided in clause (H)(ii)(III),’’. 

20 (b) LABELING REQUIREMENTS.—Section 403(q)(5) 

21 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 343(q)(5)) is amended by adding at the end the following: 

23 ‘‘(H) RESTAURANTS, RETAIL FOOD ESTABLISH24 MENTS, AND VENDING MACHINES.— 


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1 ‘‘(i) GENERAL REQUIREMENTS FOR RES2 TAURANTS AND SIMILAR RETAIL FOOD ESTABLISH3 MENTS.—Except for food described in subclause 

4 (vii), in the case of food that is a standard menu 

5 item that is offered for sale in a restaurant or simi6 lar retail food establishment that is part of a chain 

7 with 20 or more locations doing business under the 

8 same name (regardless of the type of ownership of 

9 the locations) and offering for sale substantially the 

10 same menu items, the restaurant or similar retail 

11 food establishment shall disclose the information de12 scribed in subclauses (ii) and (iii). 

13 ‘‘(ii) INFORMATION REQUIRED TO BE DIS14 CLOSED BY RESTAURANTS AND RETAIL FOOD ES15 TABLISHMENTS.—Except as provided in subclause 

16 (vii), the restaurant or similar retail food establish17 ment shall disclose in a clear and conspicuous man18 ner— 

19 ‘‘(I)(aa) in a nutrient content disclosure 

20 statement adjacent to the name of the standard 

21 menu item, so as to be clearly associated with 

22 the standard menu item, on the menu listing 

23 the item for sale, the number of calories con24 tained in the standard menu item, as usually 

25 prepared and offered for sale; and 


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1 ‘‘(bb) a succinct statement concerning sug2 gested daily caloric intake, as specified by the 

3 Secretary by regulation and posted prominently 

4 on the menu and designed to enable the public 

5 to understand, in the context of a total daily 

6 diet, the significance of the caloric information 

7 that is provided on the menu; 

8 ‘‘(II)(aa) in a nutrient content disclosure 

9 statement adjacent to the name of the standard 

10 menu item, so as to be clearly associated with 

11 the standard menu item, on the menu board, 

12 including a drive-through menu board, the 

13 number of calories contained in the standard 

14 menu item, as usually prepared and offered for 

15 sale; and 

16 ‘‘(bb) a succinct statement concerning sug17 gested daily caloric intake, as specified by the 

18 Secretary by regulation and posted prominently 

19 on the menu board, designed to enable the pub20 lic to understand, in the context of a total daily 

21 diet, the significance of the nutrition informa22 tion that is provided on the menu board; 

23 ‘‘(III) in a written form, available on the prem24 ises of the restaurant or similar retail establishment 

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1 formation required under clauses (C) and (D) of 

2 subparagraph (1); and 

3 ‘‘(IV) on the menu or menu board, a promi4 nent, clear, and conspicuous statement regarding the 

5 availability of the information described in item 

6 (III). 

7 ‘‘(iii) SELF-SERVICE FOOD AND FOOD ON DIS8 PLAY.—Except as provided in subclause (vii), in the 

9 case of food sold at a salad bar, buffet line, cafeteria 

10 line, or similar self-service facility, and for self-serv11 ice beverages or food that is on display and that is 

12 visible to customers, a restaurant or similar retail 

13 food establishment shall place adjacent to each food 

14 offered a sign that lists calories per displayed food 

15 item or per serving. 

16 ‘‘(iv) REASONABLE BASIS.—For the purposes of 

17 this clause, a restaurant or similar retail food estab18 lishment shall have a reasonable basis for its nutri19 ent content disclosures, including nutrient databases, 

20 cookbooks, laboratory analyses, and other reasonable 

21 means, as described in section 101.10 of title 21, 

22 Code of Federal Regulations (or any successor regu23 lation) or in a related guidance of the Food and 

24 Drug Administration. 


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1 ‘‘(v) MENU VARIABILITY AND COMBINATION

2 MEALS.—The Secretary shall establish by regulation 

3 standards for determining and disclosing the nutri4 ent content for standard menu items that come in 

5 different flavors, varieties, or combinations, but 

6 which are listed as a single menu item, such as soft 

7 drinks, ice cream, pizza, doughnuts, or children’s 

8 combination meals, through means determined by 

9 the Secretary, including ranges, averages, or other 

10 methods. 

11 ‘‘(vi) ADDITIONAL INFORMATION.—If the Sec12 retary determines that a nutrient, other than a nu13 trient required under subclause (ii)(III), should be 

14 disclosed for the purpose of providing information to 

15 assist consumers in maintaining healthy dietary 

16 practices, the Secretary may require, by regulation, 

17 disclosure of such nutrient in the written form re18 quired under subclause (ii)(III). 

19 ‘‘(vii) NONAPPLICABILITY TO CERTAIN FOOD.— 

20 ‘‘(I) IN GENERAL.—Subclauses (i) through 

21 (vi) do not apply to— 

22 ‘‘(aa) items that are not listed on a 

23 menu or menu board (such as condiments 

24 and other items placed on the table or 

25 counter for general use); 


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1 ‘‘(bb) daily specials, temporary menu 

2 items appearing on the menu for less than 

3 60 days per calendar year, or custom or4 ders; or 

5 ‘‘(cc) such other food that is part of 

6 a customary market test appearing on the 

7 menu for less than 90 days, under terms 

8 and conditions established by the Sec9 retary. 

10 ‘‘(II) WRITTEN FORMS.—Subparagraph 

11 (5)(C) shall apply to any regulations promul12 gated under subclauses (ii)(III) and (vi). 

13 ‘‘(viii) VENDING MACHINES.— 

14 ‘‘(I) IN GENERAL.—In the case of an arti15 cle of food sold from a vending machine that— 

16 ‘‘(aa) does not permit a prospective 

17 purchaser to examine the Nutrition Facts 

18 Panel before purchasing the article or does 

19 not otherwise provide visible nutrition in20 formation at the point of purchase; and 

21 ‘‘(bb) is operated by a person who is 

22 engaged in the business of owning or oper23 ating 20 or more vending machines, 

24 the vending machine operator shall provide a 

25 sign in close proximity to each article of food or 


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1 the selection button that includes a clear and 

2 conspicuous statement disclosing the number of 

3 calories contained in the article. 

4 ‘‘(ix) VOLUNTARY PROVISION OF NUTRITION IN5 FORMATION.— 

6 ‘‘(I) IN GENERAL.—An authorized official 

7 of any restaurant or similar retail food estab8 lishment or vending machine operator not sub9 ject to the requirements of this clause may elect 

10 to be subject to the requirements of such 

11 clause, by registering biannually the name and 

12 address of such restaurant or similar retail food 

13 establishment or vending machine operator with 

14 the Secretary, as specified by the Secretary by 

15 regulation. 

16 ‘‘(II) REGISTRATION.—Within 120 days of 

17 enactment of this clause, the Secretary shall 

18 publish a notice in the Federal Register speci19 fying the terms and conditions for implementa20 tion of item (I), pending promulgation of regu21 lations. 

22 ‘‘(III) RULE OF CONSTRUCTION.—Nothing 

23 in this subclause shall be construed to authorize 

24 the Secretary to require an application, review, 


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1 or licensing process for any entity to register 

2 with the Secretary, as described in such item. 

3 ‘‘(x) REGULATIONS.— 

4 ‘‘(I) PROPOSED REGULATION.—Not later 

5 than 1 year after the date of enactment of this 

6 clause, the Secretary shall promulgate proposed 

7 regulations to carry out this clause. 

8 ‘‘(II) CONTENTS.—In promulgating regula9 tions, the Secretary shall— 

10 ‘‘(aa) consider standardization of rec11 ipes and methods of preparation, reason12 able variation in serving size and formula13 tion of menu items, space on menus and 

14 menu boards, inadvertent human error, 

15 training of food service workers, variations 

16 in ingredients, and other factors, as the 

17 Secretary determines; and 

18 ‘‘(bb) specify the format and manner 

19 of the nutrient content disclosure require20 ments under this subclause. 

21 ‘‘(III) REPORTING.—The Secretary shall 

22 submit to the Committee on Health, Education, 

23 Labor, and Pensions of the Senate and the 

24 Committee on Energy and Commerce of the 

25 House of Representatives a quarterly report 


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1 that describes the Secretary’s progress toward 

2 promulgating final regulations under this sub3 paragraph. 

4 ‘‘(xi) DEFINITION.—In this clause, the term 

5 ‘menu’ or ‘menu board’ means the primary writing 

6 of the restaurant or other similar retail food estab7 lishment from which a consumer makes an order se8 lection.’’ 

9 (c) NATIONAL UNIFORMITY.—Section 403A(a)(4) of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 343-1(a)(4)) is amended by striking ‘‘except a require12 ment for nutrition labeling of food which is exempt under 

13 subclause (i) or (ii) of section 403(q)(5)(A)’’ and inserting 

14 ‘‘except that this paragraph does not apply to food that 

15 is offered for sale in a restaurant or similar retail food 

16 establishment that is not part of a chain with 20 or more 

17 locations doing business under the same name (regardless 

18 of the type of ownership of the locations) and offering for 

19 sale substantially the same menu items unless such res20 taurant or similar retail food establishment complies with 

21 the voluntary provision of nutrition information require22 ments under section 403(q)(5)(H)(ix)’’. 

23 (d) RULE OF CONSTRUCTION.—Nothing in the 

24 amendments made by this section shall be construed— 


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1 (1) to preempt any provision of State or local 

2 law, unless such provision establishes or continues 

3 into effect nutrient content disclosures of the type 

4 required under section 403(q)(5)(H) of the Federal 

5 Food, Drug, and Cosmetic Act (as added by sub6 section (b)) and is expressly preempted under sub7 section (a)(4) of such section; 

8 (2) to apply to any State or local requirement 

9 respecting a statement in the labeling of food that 

10 provides for a warning concerning the safety of the 

11 food or component of the food; or 

12 (3) except as provided in section 

13 403(q)(5)(H)(ix) of the Federal Food, Drug, and 

14 Cosmetic Act (as added by subsection (b)), to apply 

15 to any restaurant or similar retail food establish16 ment other than a restaurant or similar retail food 

17 establishment described in section 403(q)(5)(H)(i) of 

18 such Act. 

19 SEC. 326. ENCOURAGING EMPLOYER-SPONSORED 

20 WELLNESS PROGRAMS. 

21 A group health plan and a health insurance issuer 

22 offering health insurance coverage in connection with a 

23 group health plan may offer incentives to an individual 

24 who voluntarily participates in a wellness program that is 

25 reasonably-designed to promote health or prevent disease. 


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1 Nothing in this Act (or an amendment made by this Act) 

2 shall be construed to limit the ability of a group health 

3 plan or health insurance issuer, under regulations in effect 

4 on the date of enactment of this Act, to offer participants 

5 variations in employee contributions towards the cost of 

6 coverage for participation in wellness programs. 

7 SEC. 327. DEMONSTRATION PROJECT CONCERNING INDI8 VIDUALIZED WELLNESS PLAN. 

9 Section 330 of the Public Health Service Act (42 

10 U.S.C. 245b) is amended by adding at the end the fol11 lowing: 

12 ‘‘(s) PILOT PROGRAM FOR INDIVIDUALIZED

13 WELLNESS PLANS.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall estab15 lish a pilot program to test the impact of providing 

16 at-risk populations who utilize community health 

17 centers funded under this section an individualized 

18 wellness plan that is designed to reduce risk factors 

19 for preventable conditions as identified by a com20 prehensive risk-factor assessment. 

21 ‘‘(2) AGREEMENTS.—The Secretary shall enter 

22 into agreements with not more than 10 community 

23 health centers funded under this section to conduct 

24 activities under the pilot program under paragraph 

25 (1). 


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1 ‘‘(3) WELLNESS PLANS.— 

2 ‘‘(A) IN GENERAL.—An individualized 

3 wellness plan prepared under the pilot program 

4 under this subsection may include one or more 

5 of the following as appropriate to the individ6 ual’s identified risk factors: 

7 ‘‘(i) Nutritional counseling. 

8 ‘‘(ii) A physical activity plan. 

9 ‘‘(iii) Alcohol and smoking cessation 

10 counseling and services. 

11 ‘‘(iv) Stress management. 

12 ‘‘(v) Dietary supplements that have 

13 health claims approved by the Secretary. 

14 ‘‘(vi) Compliance assistance provided 

15 by a community health center employee. 

16 ‘‘(B) RISK FACTORS.—Wellness plan risk 

17 factors shall include— 

18 ‘‘(i) weight; 

19 ‘‘(ii) tobacco and alcohol use; 

20 ‘‘(iii) exercise rates; 

21 ‘‘(iv) nutritional status; and 

22 ‘‘(v) blood pressure. 

23 ‘‘(C) COMPARISONS.—Individualized 

24 wellness plans shall make comparisons between 

25 the individual involved and a control group of 


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1 individuals with respect to the risk factors de2 scribed in subparagraph (B). 

3 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

4 There is authorized to be appropriated to carry out 

5 this subsection, such sums as may be necessary.’’. 

6 SEC. 328. REASONABLE BREAK TIME FOR NURSING MOTH7 ERS. 

8 Section 7 of the Fair Labor Standards Act of 1938 

9 (29 U.S.C. 207) is amended by adding at the end the fol10 lowing: 

11 ‘‘(r)(1) An employer shall provide— 

12 ‘‘(A) a reasonable break time for an employee 

13 to express breast milk for her nursing child for 1 

14 year after the child’s birth each time such employee 

15 has need to express the milk; and 

16 ‘‘(B) a place, other than a bathroom, that is 

17 shielded from view and free from intrusion from co18 workers and the public, which may be used by an 

19 employee to express breast milk. 

20 ‘‘(2) An employer shall not be required to compensate 

21 an employee receiving reasonable break time under para22 graph (1) for any work time spent for such purpose. 

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1 ship by causing the employer significant difficulty or ex2 pense when considered in relation to the size, financial re3 sources, nature, or structure of the employer’s business.’’. 

4 Subtitle D—Support for Prevention 

5 and Public Health Innovation 

6 SEC. 331. RESEARCH ON OPTIMIZING THE DELIVERY OF 

7 PUBLIC HEALTH SERVICES. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this section as the ‘‘Sec10 retary’’), acting through the Director of the Centers for 

11 Disease Control and Prevention, shall provide funding for 

12 research in the area of public health services and systems. 

13 (b) REQUIREMENTS OF RESEARCH.—Research sup14 ported under this section shall include— 

15 (1) examining evidence-based practices relating 

16 to prevention, with a particular focus on high pri17 ority areas as identified by the Secretary in the Na18 tional Prevention Strategy or Healthy People 2020, 

19 and including comparing community-based public 

20 health interventions in terms of effectiveness and 

21 cost; 

22 (2) analyzing the translation of interventions 

23 from academic settings to real world settings; and 

24 (3) identifying effective strategies for orga25 nizing, financing, or delivering public health services 


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1 in real world community settings, including com2 paring State and local health department structures 

3 and systems in terms of effectiveness and cost. 

4 (c) EXISTING PARTNERSHIPS.—Research supported 

5 under this section shall be coordinated with the Commu6 nity Preventive Services Task Force and carried out by 

7 building on existing partnerships within the Federal Gov8 ernment while also considering initiatives at the State and 

9 local levels and in the private sector. 

10 (d) ANNUAL REPORT.—The Secretary shall, on an 

11 annual basis, submit to Congress a report concerning the 

12 activities and findings with respect to research supported 

13 under this section. 

14 SEC. 332. UNDERSTANDING HEALTH DISPARITIES: DATA 

15 COLLECTION AND ANALYSIS. 

16 The Public Health Service Act (42 U.S.C. 201 et 

17 seq.) as amended by section 172, is further amended by 

18 adding at the end the following: 

19 ‘‘TITLE XXXIII—DATA COLLEC20 TION, ANALYSIS, AND QUAL21 ITY 

22 ‘‘SEC. 3301. DATA COLLECTION, ANALYSIS, AND QUALITY. 

23 ‘‘(a) DATA COLLECTION.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall ensure 

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1 actment of this title, any ongoing or federally con2 ducted or supported health care or public health pro3 gram, activity or survey collects and reports— 

4 ‘‘(A) data on race and ethnicity for appli5 cants, recipients, or beneficiaries; 

6 ‘‘(B) data on gender, geographic location, 

7 socioeconomic status (including education, em8 ployment or income), primary language, and, 

9 disability status data for applicants, recipients, 

10 or beneficiaries; 

11 ‘‘(C) data at the smallest geographic level 

12 such as State, local, or institutional levels if 

13 such data can be aggregated; 

14 ‘‘(D) if practicable, data by racial and eth15 nic subgroups for applicants, recipients or bene16 ficiaries using, if needed, statistical oversamples 

17 of these subpopulations; and 

18 ‘‘(E) any other demographic data as 

19 deemed appropriate by the Secretary regarding 

20 health disparities. 

21 ‘‘(2) COLLECTION STANDARDS.—In collecting 

22 data described in paragraph (1), the Secretary or 

23 designee shall— 


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1 ‘‘(A) use Office of Management and Budg2 et standards, at a minimum, for race and eth3 nicity measures; 

4 ‘‘(B) develop standards for the measure5 ment of gender, geographic location, socio6 economic status, primary language and dis7 ability measures; and 

8 ‘‘(C) develop standards for the collection of 

9 data described in paragraph (1) that, at a min10 imum— 

11 ‘‘(i) collects self-reported data by the 

12 applicant, recipient, or beneficiary; and 

13 ‘‘(ii) collects data from a parent or 

14 legal guardian if the applicant, recipient, 

15 or beneficiary is a minor or legally inca16 pacitated. 

17 ‘‘(3) DATA MANAGEMENT.—In collecting data 

18 described in paragraph (1), the Secretary, acting 

19 through the National Coordinator for Health Infor20 mation Technology shall— 

21 ‘‘(A) develop national standards for the 

22 management of data collected; and 

23 ‘‘(B) develop interoperability and security 

24 systems for data management. 

25 ‘‘(b) DATA ANALYSIS.— 


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1 ‘‘(1) IN GENERAL.—For each federally con2 ducted or supported health care or public health pro3 gram or activity, the Secretary shall analyze data 

4 collected under paragraph (a) to detect and monitor 

5 trends in health disparities (as defined in section 

6 485E) at the Federal and State levels. 

7 ‘‘(c) DATA REPORTING AND DISSEMINATION.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall make 

9 the analyses described in (b) available to— 

10 ‘‘(A) the Office of Minority Health; 

11 ‘‘(B) the National Center on Minority 

12 Health and Health Disparities; 

13 ‘‘(C) the Agency for Healthcare Research 

14 and Quality; 

15 ‘‘(D) the Centers for Disease Control and 

16 Prevention; 

17 ‘‘(E) the Centers for Medicare & Medicaid 

18 Services; 

19 ‘‘(F) the Indian Health Service and epide20 miology centers funded under the Indian Health 

21 Care Improvement Act; 

22 ‘‘(G) other agencies within the Department 

23 of Health and Human Services; and 

24 ‘‘(H) other entities as determined appro25 priate by the Secretary. 


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1 ‘‘(2) REPORTING OF DATA.—The Secretary 

2 shall report data and analyses described in (a) and 

3 (b) through— 

4 ‘‘(A) public postings on the Internet 

5 websites of the Department of Health and 

6 Human Services; and 

7 ‘‘(B) any other reporting or dissemination 

8 mechanisms determined appropriate by the Sec9 retary. 

10 ‘‘(3) AVAILABILITY OF DATA.—The Secretary 

11 may make data described in (a) and (b) available for 

12 additional research, analyses, and dissemination to 

13 other Federal agencies, non-governmental entities, 

14 and the public. 

15 ‘‘(d) LIMITATIONS ON USE OF DATA.—Nothing in 

16 this section shall be construed to permit the use of infor17 mation collected under this section in a manner that would 

18 adversely affect any individual. 

19 ‘‘(e) PROTECTION OF DATA.—The Secretary shall en20 sure (through the promulgation of regulations or other21 wise) that all data collected pursuant to subsection (a) is 

22 protected— 

23 ‘‘(1) under the same privacy protections that 

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1 mulgated under section 264(c) of the Health Insur2 ance Portability and Accountability Act of 1996 

3 (Public Law 104-191; 110 Stat. 2033); and 

4 ‘‘(2) from all inappropriate internal use by any 

5 entity that collects, stores, or receives the data, in6 cluding use of such data in determinations of eligi7 bility (or continued eligibility) in health plans, and 

8 from other inappropriate uses, as defined by the 

9 Secretary. 

10 ‘‘(f) DATA ON RURAL UNDERSERVED POPU11 LATIONS.—The Secretary shall ensure that any data col12 lected in accordance with this section regarding racial and 

13 ethnic minority groups is also collected regarding under14 served rural and frontier populations. 

15 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For the 

16 purpose of carrying out this section, there are authorized 

17 to be appropriated such sums as may be necessary for 

18 each of fiscal years 2010 through 2014. 

19 ‘‘(h) REQUIREMENT FOR IMPLEMENTATION.—Not20 withstanding any other provision of this section, data may 

21 not be collected under this section unless funds are di22 rectly appropriated for such purpose in an appropriations 

23 Act.’’. 


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1 SEC. 333. HEALTH IMPACT ASSESSMENTS. 

2 (a) PURPOSE.—It is the purpose of this section to 

3 determine if the built environment has an impact on 

4 health. 

5 (b) DEFINITION.—In this section: 

6 (1) ADMINISTRATOR.—The term ‘‘Adminis7 trator’’ means the Administrator of the Environ8 mental Protection Agency. 

9 (2) BUILT ENVIRONMENT.—The term ‘‘built 

10 environment’’ means an environment consisting of 

11 building, spaces, and products that are created or 

12 modified by individuals and entities, including 

13 homes, schools, workplaces, greenways, business 

14 areas, transportation systems, and parks and recre15 ation areas, electrical transmission lines, waste dis16 posal sites, and land-use planning and policies that 

17 impact urban, rural and suburban communities. 

18 (3) DIRECTOR.—The term ‘‘Director’’ means 

19 the Director of the Centers for Disease Control and 

20 Prevention. 

21 (4) ENVIRONMENTAL HEALTH.—The term ‘‘en22 vironmental health’’ means the health and wellbeing 

23 of a population as affected by the direct pathological 

24 effects of chemicals, radiation or biological agents, 

25 and the effects, including the indirect effects, of the 


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1 broad physical, psychological, social and aesthetic 

2 environment. 

3 (5) HEALTH IMPACT ASSESSMENT.—The term 

4 ‘‘health impact assessment’’ means a combination of 

5 procedures, methods, and tools by which a regula6 tion, program, or other project is assessed as to its 

7 potential effects on the health of a population, and 

8 the distribution of those effects within the popu9 lation. 

10 (6) SECRETARY.—The term ‘‘Secretary’’ means 

11 the Secretary of Health and Human Services. 

12 (c) FOSTERING HEALTH IMPACT ASSESSMENT.— 

13 (1) ESTABLISHMENT.—The Secretary, acting 

14 through the Director and in coordination with the 

15 Administrator, shall establish a program at the Na16 tional Center of Environmental Health at the Cen17 ters for Disease Control and Prevention to foster ad18 vances and provide technical support in the field of 

19 health impact assessments. 

20 (2) ACTIVITIES.—Through the program under 

21 paragraph (1), the Secretary shall— 

22 (A) collect and disseminate evidence-based 

23 practices relating to health impact assessments; 


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1 (B) manage capacity building grants, tech2 nical assistance, and training on the use of 

3 health impact assessments; and 

4 (C) provide guidance on health impact as5 sessments including similar international ef6 forts, known associations between the built en7 vironment and health outcomes, forecasting of 

8 potential health effects of the built environ9 ment, and best practices relating to the inclu10 sion of the public in planning processes. 

11 SEC. 334. CDC AND EMPLOYER-BASED WELLNESS PRO12 GRAMS. 

13 Title III of the Public Health Service Act (42 U.S.C. 

14 241 et seq.), as amended by section 314) is further 

15 amended by adding at the end the following: 

16 ‘‘PART T—EMPLOYER-BASED WELLNESS 

17 PROGRAM 

18 ‘‘SEC. 399HH. WORKPLACE WELLNESS MARKETING CAM19 PAIGN. 

20 ‘‘Subject to appropriations Acts, the Director of the 

21 Centers for Disease Control and Prevention (referred to 

22 in this section as the ‘Director’), in coordination with rel23 evant worksite health promotion organizations, State and 

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1 dian tribes and tribal organizations, and academic institu2 tions, shall conduct targeted educational campaigns to— 

3 ‘‘(1) make employers, employer groups, and 

4 other interested parties aware of the benefits of em5 ployer-based wellness programs; 

6 ‘‘(2) establish a culture of health by empha7 sizing health promotion and disease prevention; 

8 ‘‘(3) emphasize an integrated and coordinated 

9 approach to workplace wellness; and 

10 ‘‘(4) ensure informed decisions through high 

11 quality information to organizational leaders. 

12 ‘‘SEC. 399HH-1. TECHNICAL ASSISTANCE FOR EMPLOYER13 BASED WELLNESS PROGRAMS. 

14 ‘‘In order to expand the utilization of evidence-based 

15 prevention and health promotion approaches in the work16 place, the Director shall— 

17 ‘‘(1) provide employers (including small, me18 dium, and large employers, as determined by the Di19 rector) with technical assistance, consultation, tools, 

20 and other resources in evaluating such employers’ 

21 employer-based wellness programs, including— 

22 ‘‘(A) measuring the participation and 

23 methods to increase participation of employees 

24 in such programs; 


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1 ‘‘(B) developing standardized measures 

2 that assess policy, environmental and systems 

3 changes necessary to have a positive health im4 pact on employees’ health behaviors, health out5 comes, and health care expenditures; and 

6 ‘‘(C) evaluating such programs as they re7 late to changes in the health status of employ8 ees, the absenteeism of employees, the produc9 tivity of employees, the rate of workplace in10 jury, and the medical costs incurred by employ11 ees; and 

12 ‘‘(2) build evaluation capacity among workplace 

13 staff by training employers on how to evaluate em14 ployer-based wellness programs by ensuring evalua15 tion resources, technical assistance, and consultation 

16 are available to workplace staff as needed through 

17 such mechanisms as web portals, call centers, or 

18 other means. 

19 ‘‘SEC. 399HH-2. NATIONAL WORKSITE HEALTH POLICIES 

20 AND PROGRAMS STUDY. 

21 ‘‘(a) IN GENERAL.—In order to assess, analyze, and 

22 monitor over time data about workplace policies and pro23 grams, and to develop instruments to assess and evaluate 

24 comprehensive workplace chronic disease prevention and 

25 health promotion programs, policies and practices, not 


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1 later than 2 years after the date of enactment of this part, 

2 and at regular intervals (to be determined by the Director) 

3 thereafter, the Director shall conduct a national worksite 

4 health policies and programs survey to assess employer5 based health policies and programs. 

6 ‘‘(b) REPORT.—Upon the completion of each study 

7 under subsection (a), the Director shall submit to Con8 gress a report that includes the recommendations of the 

9 Director for the implementation of effective employer10 based health policies and programs. 

11 ‘‘SEC. 399HH-3. RESEARCH IN WORKPLACE WELLNESS. 

12 ‘‘(a) WORKPLACE DEMONSTRATION STUDIES.—To 

13 expand the science base for effective prevention and health 

14 promotion approaches in the workplace, the Director, in 

15 collaboration with academic institutions and employers, 

16 shall institute workplace demonstration projects across 

17 small, medium, and large employers. Such demonstration 

18 projects shall be designed to determine how best to trans19 form the work environment for health, safety, and 

20 wellness, how to create a strong, sustainable, coordinated, 

21 and integrated workplace health promotion and wellness 

22 program, and how to create innovative and sustainable 

23 policy and environmental strategies to improve employee 

24 health and wellness. 


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1 ‘‘(b) REPORT.—Upon the completion of the study 

2 under subsection (b), the Director shall submit to Con3 gress a report that includes the recommendations of the 

4 Director for the implementation of effective employer5 based health policies and programs. 

6 ‘‘SEC. 399HH–4. PRIORITIZATION OF EVALUATION BY SEC7 RETARY. 

8 ‘‘The Secretary shall evaluate, in accordance with this 

9 part, all programs funded through the Centers for Disease 

10 Control and Prevention before conducting such an evalua11 tion of privately funded programs unless an entity with 

12 a privately funded wellness program requests such an eval13 uation. 

14 ‘‘SEC. 399HH–5. PROHIBITION OF FEDERAL WORKPLACE 

15 WELLNESS REQUIREMENTS. 

16 ‘‘Notwithstanding any other provision of this part, 

17 any recommendations, data, or assessments carried out 

18 under this part shall not be used to mandate requirements 

19 for workplace wellness programs.’’. 

20 SEC. 335. EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS. 

21 Title XXVIII of the Public Health Service Act (42 

22 U.S.C. 300hh et seq.) is amended by adding at the end 

23 the following: 


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1 ‘‘Subtitle C—Strengthening Public 

2 Health Surveillance Systems 

3 ‘‘SEC. 2821. EPIDEMIOLOGY-LABORATORY CAPACITY 

4 GRANTS. 

5 ‘‘(a) IN GENERAL.—Subject to the availability of ap6 propriations, the Secretary, acting through the Director 

7 of the Centers for Disease Control and Prevention, shall 

8 establish an Epidemiology and Laboratory Capacity Grant 

9 Program to award grants to eligible entities to assist pub10 lic health agencies in improving surveillance for, and re11 sponse to, infectious diseases and other conditions of pub12 lic health importance by— 

13 ‘‘(1) strengthening epidemiologic capacity; 

14 ‘‘(2) enhancing laboratory practice; 

15 ‘‘(3) improving information systems; and 

16 ‘‘(4) developing and implementing prevention 

17 and control strategies. 

18 ‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 

19 ‘eligible entity’ means an entity that— 

20 ‘‘(1) is— 

21 ‘‘(A) a State health department; 

22 ‘‘(B) a local health department that meets 

23 such criteria as the Director of the Centers for 

24 Diseases Control and Prevention determines for 

25 purposes of this section; 


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1 ‘‘(C) a tribal jurisdiction that meets such 

2 criteria as the Director of the Centers for Dis3 ease Control and Prevention determines for 

4 purposes of this section; or 

5 ‘‘(D) a partnership established for pur6 poses of this section between one or more eligi7 ble entities described in subparagraph (A), (B), 

8 or (C) and an academic center; and 

9 ‘‘(2) submits to the Secretary an application at 

10 such time, in such manner, and containing such in11 formation as the Secretary may require. 

12 ‘‘(c) USE OF FUNDS.— 

13 ‘‘(1) IN GENERAL.—An eligible entity shall use 

14 amounts received under a grant under this section 

15 for core functions described in this subsection in16 cluding— 

17 ‘‘(A) building public health capacity to 

18 identify and monitor the occurrence of infec19 tious diseases and other conditions of public 

20 health importance; 

21 ‘‘(B) detecting new and emerging infec22 tious disease threats, including laboratory ca23 pacity to detect antimicrobial resistant infec24 tions; 


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1 ‘‘(C) identifying and responding to disease 

2 outbreaks; 

3 ‘‘(D) hiring necessary staff; 

4 ‘‘(E) conducting needed staff training and 

5 educational development; and 

6 ‘‘(F) other activities that improve surveil7 lance as determined by the Director of the Cen8 ters for Disease Control and Prevention. 

9 ‘‘(2) DEVELOPMENT AND MAINTENANCE OF IN10 FORMATION EXCHANGE.— 

11 ‘‘(A) NATIONAL STANDARDS.—Not later 

12 than 180 days after the date of the enactment 

13 of this subtitle, the Secretary, acting through 

14 the Director of the Centers for Disease Control 

15 and Prevention, and in consultation with the 

16 National Coordinator for Health Information 

17 Technology, shall issue guidelines for public 

18 health entities that— 

19 ‘‘(i) are designed to ensure that all 

20 State and local health departments and 

21 public health laboratories have access to 

22 information systems to receive, monitor, 

23 and report infectious diseases and other 

24 urgent conditions of public health impor25 tance; and 


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1 ‘‘(ii) are consistent with standards 

2 and recommendations for health informa3 tion technology by the National Coordi4 nator for Health Information Technology, 

5 and by the American Health Information 

6 Community (AHIC) and its successors. 

7 ‘‘(B) SECURE INFORMATION SYSTEMS.— 

8 An eligible entity shall use amounts received 

9 through a grant under this section to ensure 

10 that the entity has access to a web-based, se11 cure information system that complies with the 

12 guidelines developed under subparagraph (A). 

13 Such a system shall be designed— 

14 ‘‘(i) to receive automated case reports 

15 of State and national reportable conditions 

16 from clinical systems and health care of17 fices that use electronic health records and 

18 from clinical and public health labora19 tories, and to submit reports of nationally 

20 reportable conditions to the Director of the 

21 Centers for Disease Control and Preven22 tion; 

23 ‘‘(ii) to receive and analyze, within 24 

24 hours, de-identified electronic clinical data 

25 for situational awareness and to forward 


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1 such reports immediately to the Centers 

2 for Disease Control and Prevention at the 

3 time of receipt; 

4 ‘‘(iii) to manage, link, and process dif5 ferent types of data, including information 

6 on newly reported cases, exposed contacts, 

7 laboratory results, number of people vac8 cinated or given prophylactic medications, 

9 adverse events monitoring and follow-up, in 

10 an integrated outbreak management sys11 tem; 

12 ‘‘(iv) to geocode analyze, display, re13 port, and map, using Geographic Informa14 tion System technology, accumulated data 

15 and to share data with other local health 

16 departments, State health departments, 

17 and the Centers for Disease Control and 

18 Prevention; 

19 ‘‘(v) to receive, manage, and dissemi20 nate alerts, protocols, and other informa21 tion, including Health Alert Network and 

22 Epi-X information, as appropriate, for 

23 public health workers, health care pro24 viders, and public health partners in emer25 gency response within each health departVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00538 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 ment’s jurisdiction and to automate the ex2 change and cascading of such information 

3 with external partners using national 

4 standards; 

5 ‘‘(vi) to have information technology 

6 security and critical infrastructure protec7 tion as appropriate to protect public health 

8 information; 

9 ‘‘(vii) to have the technical infrastruc10 ture needed to ensure availability, backup, 

11 and disaster recovery of data, application 

12 services, and communications systems dur13 ing natural disasters such as floods, tor14 nados, hurricanes, and power outages; and 

15 ‘‘(viii) to provide for other capabilities 

16 as the Secretary determines appropriate. 

17 ‘‘(C) LABORATORY SYSTEMS.—An eligible 

18 entity shall use amounts received under a grant 

19 under this section to ensure that State or local 

20 public health laboratories are utilizing web21 based, secure systems that are in compliance 

22 with the guidelines developed by the Secretary 

23 under subparagraph (A) and that— 

24 ‘‘(i) are fully integrated laboratory in25 formation systems; 


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1 ‘‘(ii) provide for the reporting of elec2 tronic test results to the appropriate local 

3 and State health departments using cur4 rently existing national format and coding 

5 standards; 

6 ‘‘(iii) have information technology se7 curity and critical infrastructure protection 

8 to protect public health information (as de9 termined by the Secretary); 

10 ‘‘(iv) have the technical infrastructure 

11 needed to ensure availability, backup, and 

12 disaster recovery of data, application serv13 ices, and communications systems during 

14 natural disasters including floods, torna15 does, hurricanes, and power outages; and 

16 ‘‘(v) address other capabilities as the 

17 Secretary determines appropriate. 

18 ‘‘(D) OTHER USES.—In addition to the ac19 tivities described in subparagraphs (B) and (C), 

20 an eligible entity (including the entity’s public 

21 health laboratory) may use amounts received 

22 under a grant under this section for systems 

23 development and maintenance, hiring necessary 

24 staff, and staff technical training. Grantees 

25 under this section may elect to develop their 


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1 own systems or use federally developed systems 

2 in carrying out activities under this paragraph. 

3 ‘‘(d) PRIORITY.—In allocating funds under sub4 section (f)(2) for activities under subsection (c)(2)(B) (re5 lating to secure information systems), the Secretary shall 

6 give priority to eligible entities that demonstrate need. 

7 ‘‘(e) REPORTS.—Not later than September 30, 2011, 

8 and each September 30 thereafter, the Secretary shall 

9 submit to Congress an annual report on the activities car10 ried out under this section by recipients of assistance 

11 under this section. 

12 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 $190,000,000 for each of fiscal years 2010 through 2013, 

15 of which— 

16 ‘‘(1) not less than $95,000,000 shall be made 

17 available each such fiscal year for activities under 

18 subsection (c)(1); 

19 ‘‘(2) not less than $60,000,000 shall be made 

20 available each such fiscal year for activities under 

21 subsection (c)(2)(B); and 

22 ‘‘(3) not less than $32,000,000 shall be made 

23 available each such fiscal year for activities under 

24 subsection (c)(2)(C).’’. 


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1 SEC. 336. FEDERAL MESSAGING ON HEALTH PROMOTION 

2 AND DISEASE PREVENTION. 

3 (a) MEDIA CAMPAIGN.— 

4 (1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of this Act, the Secretary of 

6 Health and Human Services (referred to in this sec7 tion as the ‘‘Secretary’’), acting through the Direc8 tor of the Centers for Disease Control and Preven9 tion, shall establish and implement a national 

10 science-based media campaign on health promotion 

11 and disease prevention. 

12 (2) REQUIREMENTS OF CAMPAIGN.—The cam13 paign implemented under paragraph (1)— 

14 (A) shall be designed to address proper nu15 trition, regular exercise, smoking cessation, obe16 sity reduction, the 5 leading disease killers in 

17 the United States, and secondary prevention 

18 through disease screening promotion; 

19 (B) shall be carried out through competi20 tively bid contracts awarded to entities pro21 viding for the professional production and de22 sign of such campaign; 

23 (C) may include the use of television, 

24 radio, Internet, and other commercial mar25 keting venues and may be targeted to specific 


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1 age groups based on peer-reviewed social re2 search; 

3 (D) shall not be duplicative of any other 

4 Federal efforts relating to health promotion and 

5 disease prevention; and 

6 (E) may include the use of humor and na7 tionally recognized positive role models. 

8 (3) EVALUATION.—The Secretary shall ensure 

9 that the campaign implemented under paragraph (1) 

10 is subject to an independent evaluation every 2 years 

11 and shall report every 2 years to Congress on the ef12 fectiveness of such campaigns towards meeting 

13 science-based metrics. 

14 (b) WEBSITE.—The Secretary, in consultation with 

15 private-sector experts, shall maintain or enter into a con16 tract to maintain an Internet website to provide science17 based information on guidelines for nutrition, regular ex18 ercise, obesity reduction, smoking cessation, and specific 

19 chronic disease prevention. Such website shall be designed 

20 to provide information to health care providers and con21 sumers. 

22 (c) DISSEMINATION OF INFORMATION THROUGH

23 PROVIDERS.—The Secretary, acting through the Centers 

24 for Disease Control and Prevention, shall develop and im25 plement a plan for the dissemination of health promotion 


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1 and disease prevention information consistent with na2 tional priorities, to health care providers who participate 

3 in Federal programs, including programs administered by 

4 the Indian Health Service, the Department of Veterans 

5 Affairs, the Department of Defense, and the Health Re6 sources and Services Administration, and the Medicare 

7 and Medicaid Programs. 

8 (d) PERSONALIZED PREVENTION PLANS.— 

9 (1) CONTRACT.—The Secretary, acting through 

10 the Director of the Centers for Disease Control and 

11 Prevention, shall enter into a contract with a quali12 fied entity for the development and operation of a 

13 Federal Internet website personalized prevention 

14 plan tool. 

15 (2) USE.—The website developed under para16 graph (1) shall be designed to be used as a source 

17 of the most up-to-date scientific evidence relating to 

18 disease prevention for use by individuals. Such 

19 website shall contain a component that enables an 

20 individual to determine their disease risk (based on 

21 personal health and family history, BMI, and other 

22 relevant information) relating to the 5 leading dis23 eases in the United States, and obtain personalized 

24 suggestions for preventing such diseases. 


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1 (e) INTERNET PORTAL.—The Secretary shall estab2 lish an Internet portal for accessing risk-assessment tools 

3 developed and maintained by private and academic enti4 ties. 

5 (f) PRIORITY FUNDING.—Funding for the activities 

6 authorized under this section shall take priority over fund7 ing provided through the Centers for Disease Control and 

8 Prevention for grants to States and other entities for simi9 lar purposes and goals as provided for in this section. Not 

10 to exceed $500,000,000 shall be expended on the cam11 paigns and activities required under this section. 

12 Subtitle E—Advancing Research 

13 and Treatment for Pain Care 

14 Management 

15 SEC. 341. INSTITUTE OF MEDICINE CONFERENCE ON PAIN. 

16 (a) CONVENING.—Not later than June 30, 2010, the 

17 Secretary of Health and Human Services shall seek to 

18 enter into an agreement with the Institute of Medicine of 

19 the National Academies to convene a Conference on Pain 

20 (in this section referred to as ‘‘the Conference’’). 

21 (b) PURPOSES.—The purposes of the Conference 

22 shall be to— 

23 (1) increase the recognition of pain as a signifi24 cant public health problem in the United States; 


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1 (2) evaluate the adequacy of assessment, diag2 nosis, treatment, and management of acute and 

3 chronic pain in the general population, and in identi4 fied racial, ethnic, gender, age, and other demo5 graphic groups that may be disproportionately af6 fected by inadequacies in the assessment, diagnosis, 

7 treatment, and management of pain; 

8 (3) identify barriers to appropriate pain care, 

9 including— 

10 (A) lack of understanding and education 

11 among employers, patients, health care pro12 viders, regulators, and third-party payors; 

13 (B) barriers to access to care at the pri14 mary, specialty, and tertiary care levels, includ15 ing barriers— 

16 (i) specific to those populations that 

17 are disproportionately undertreated for 

18 pain; 

19 (ii) related to physician concerns over 

20 regulatory and law enforcement policies 

21 applicable to some pain therapies; and 

22 (iii) attributable to benefit, coverage, 

23 and payment policies in both the public 

24 and private sectors; and 


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1 (C) gaps in basic and clinical research on 

2 the symptoms and causes of pain, and potential 

3 assessment methods and new treatments to im4 prove pain care; and 

5 (4) establish an agenda for action in both the 

6 public and private sectors that will reduce such bar7 riers and significantly improve the state of pain care 

8 research, education, and clinical care in the United 

9 States. 

10 (c) OTHER APPROPRIATE ENTITY.—If the Institute 

11 of Medicine declines to enter into an agreement under sub12 section (a), the Secretary of Health and Human Services 

13 may enter into such agreement with another appropriate 

14 entity. 

15 (d) REPORT.—A report summarizing the Con16 ference’s findings and recommendations shall be sub17 mitted to the Congress not later than June 30, 2011. 

18 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

19 purpose of carrying out this section, there is authorized 

20 to be appropriated $500,000 for each of fiscal years 2010 

21 and 2011. 


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1 SEC. 342. PAIN RESEARCH AT NATIONAL INSTITUTES OF 

2 HEALTH. 

3 Part B of title IV of the Public Health Service Act 

4 (42 U.S.C. 284 et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 409J. PAIN RESEARCH. 

7 ‘‘(a) RESEARCH INITIATIVES.— 

8 ‘‘(1) IN GENERAL.—The Director of NIH is en9 couraged to continue and expand, through the Pain 

10 Consortium, an aggressive program of basic and 

11 clinical research on the causes of and potential treat12 ments for pain. 

13 ‘‘(2) ANNUAL RECOMMENDATIONS.—Not less 

14 than annually, the Pain Consortium, in consultation 

15 with the Division of Program Coordination, Plan16 ning, and Strategic Initiatives, shall develop and 

17 submit to the Director of NIH recommendations on 

18 appropriate pain research initiatives that could be 

19 undertaken with funds reserved under section 

20 402A(c)(1) for the Common Fund or otherwise 

21 available for such initiatives. 

22 ‘‘(3) DEFINITION.—In this subsection, the term 

23 ‘Pain Consortium’ means the Pain Consortium of 

24 the National Institutes of Health or a similar trans25 National Institutes of Health coordinating entity 


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1 designated by the Secretary for purposes of this sub2 section. 

3 ‘‘(b) INTERAGENCY PAIN RESEARCH COORDINATING

4 COMMITTEE.— 

5 ‘‘(1) ESTABLISHMENT.—The Secretary shall es6 tablish not later than 1 year after the date of the 

7 enactment of this section and as necessary maintain 

8 a committee, to be known as the Interagency Pain 

9 Research Coordinating Committee (in this section 

10 referred to as the ‘Committee’), to coordinate all ef11 forts within the Department of Health and Human 

12 Services and other Federal agencies that relate to 

13 pain research. 

14 ‘‘(2) MEMBERSHIP.— 

15 ‘‘(A) IN GENERAL.—The Committee shall 

16 be composed of the following voting members: 

17 ‘‘(i) Not more than 7 voting Federal 

18 representatives as follows: 

19 ‘‘(I) The Director of the Centers 

20 for Disease Control and Prevention. 

21 ‘‘(II) The Director of the Na22 tional Institutes of Health and the di23 rectors of such national research insti24 tutes and national centers as the Sec25 retary determines appropriate. 


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1 ‘‘(III) The heads of such other 

2 agencies of the Department of Health 

3 and Human Services as the Secretary 

4 determines appropriate. 

5 ‘‘(IV) Representatives of other 

6 Federal agencies that conduct or sup7 port pain care research and treat8 ment, including the Department of 

9 Defense and the Department of Vet10 erans Affairs. 

11 ‘‘(ii) 12 additional voting members ap12 pointed under subparagraph (B). 

13 ‘‘(B) ADDITIONAL MEMBERS.—The Com14 mittee shall include additional voting members 

15 appointed by the Secretary as follows: 

16 ‘‘(i) 6 members shall be appointed 

17 from among scientists, physicians, and 

18 other health professionals, who— 

19 ‘‘(I) are not officers or employees 

20 of the United States; 

21 ‘‘(II) represent multiple dis22 ciplines, including clinical, basic, and 

23 public health sciences; 


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1 ‘‘(III) represent different geo2 graphical regions of the United 

3 States; and 

4 ‘‘(IV) are from practice settings, 

5 academia, manufacturers or other re6 search settings; and 

7 ‘‘(ii) 6 members shall be appointed 

8 from members of the general public, who 

9 are representatives of leading research, ad10 vocacy, and service organizations for indi11 viduals with pain-related conditions. 

12 ‘‘(C) NONVOTING MEMBERS.—The Com13 mittee shall include such nonvoting members as 

14 the Secretary determines to be appropriate. 

15 ‘‘(3) CHAIRPERSON.—The voting members of 

16 the Committee shall select a chairperson from 

17 among such members. The selection of a chairperson 

18 shall be subject to the approval of the Director of 

19 NIH. 

20 ‘‘(4) MEETINGS.—The Committee shall meet at 

21 the call of the chairperson of the Committee or upon 

22 the request of the Director of NIH, but in no case 

23 less often than once each year. 

24 ‘‘(5) DUTIES.—The Committee shall— 


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1 ‘‘(A) develop a summary of advances in 

2 pain care research supported or conducted by 

3 the Federal agencies relevant to the diagnosis, 

4 prevention, and treatment of pain and diseases 

5 and disorders associated with pain; 

6 ‘‘(B) identify critical gaps in basic and 

7 clinical research on the symptoms and causes of 

8 pain; 

9 ‘‘(C) make recommendations to ensure that 

10 the activities of the National Institutes of 

11 Health and other Federal agencies, including 

12 the Department of Defense and the Department 

13 of Veteran Affairs, are free of unnecessary du14 plication of effort; 

15 ‘‘(D) make recommendations on how best 

16 to disseminate information on pain care; and 

17 ‘‘(E) make recommendations on how to ex18 pand partnerships between public entities, in19 cluding Federal agencies, and private entities to 

20 expand collaborative, cross-cutting research. 

21 ‘‘(6) REVIEW.—The Secretary shall review the 

22 necessity of the Committee at least once every 2 

23 years.’’. 


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1 SEC. 343. PAIN CARE EDUCATION AND TRAINING. 

2 Part D of title VII of the Public Health Service Act 

3 (42 U.S.C. 294 et seq.) is amended by adding at the end 

4 the following new section: 

5 ‘‘SEC. 759. PROGRAM FOR EDUCATION AND TRAINING IN 

6 PAIN CARE. 

7 ‘‘(a) IN GENERAL.—The Secretary may make awards 

8 of grants, cooperative agreements, and contracts to health 

9 professions schools, hospices, and other public and private 

10 entities for the development and implementation of pro11 grams to provide education and training to health care 

12 professionals in pain care. 

13 ‘‘(b) PRIORITIES.—In making awards under sub14 section (a), the Secretary shall give priority to awards for 

15 the implementation of programs under such subsection. 

16 ‘‘(c) CERTAIN TOPICS.—An award may be made 

17 under subsection (a) only if the applicant for the award 

18 agrees that the program carried out with the award will 

19 include information and education on— 

20 ‘‘(1) recognized means for assessing, diag21 nosing, treating, and managing pain and related 

22 signs and symptoms, including the medically appro23 priate use of controlled substances; 

24 ‘‘(2) applicable laws, regulations, rules, and 

25 policies on controlled substances, including the de26 gree to which misconceptions and concerns regarding 


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1 such laws, regulations, rules, and policies, or the en2 forcement thereof, may create barriers to patient ac3 cess to appropriate and effective pain care; 

4 ‘‘(3) interdisciplinary approaches to the delivery 

5 of pain care, including delivery through specialized 

6 centers providing comprehensive pain care treatment 

7 expertise; 

8 ‘‘(4) cultural, linguistic, literacy, geographic, 

9 and other barriers to care in underserved popu10 lations; and 

11 ‘‘(5) recent findings, developments, and im12 provements in the provision of pain care. 

13 ‘‘(d) PROGRAM SITES.—Education and training 

14 under subsection (a) may be provided at or through health 

15 professions schools, residency training programs, and 

16 other graduate programs in the health professions; entities 

17 that provide continuing education in medicine, pain man18 agement, dentistry, psychology, social work, nursing, and 

19 pharmacy; hospices; and such other programs or sites as 

20 the Secretary determines to be appropriate. 

21 ‘‘(e) EVALUATION OF PROGRAMS.—The Secretary 

22 shall (directly or through grants or contracts) provide for 

23 the evaluation of programs implemented under subsection 

24 (a) in order to determine the effect of such programs on 

25 knowledge and practice of pain care. 


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1 ‘‘(f) PEER REVIEW GROUPS.—In carrying out section 

2 799(f) with respect to this section, the Secretary shall en3 sure that the membership of each peer review group in4 volved includes individuals with expertise and experience 

5 in pain care. 

6 ‘‘(g) PAIN CARE DEFINED.—For purposes of this 

7 section the term ‘pain care’ means the assessment, diag8 nosis, treatment, or management of acute or chronic pain 

9 regardless of causation or body location. 

10 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

11 is authorized to be appropriated to carry out this section, 

12 $5,000,000 for each of the fiscal years 2010 through 

13 2012. Amounts appropriated under this subsection shall 

14 remain available until expended.’’. 

15 SEC. 344. PUBLIC AWARENESS CAMPAIGN ON PAIN MAN16 AGEMENT. 

17 Part B of title II of the Public Health Service Act 

18 (42 U.S.C. 238 et seq.) is amended by adding at the end 

19 the following: 

20 ‘‘SEC. 249. NATIONAL EDUCATION OUTREACH AND AWARE21 NESS CAMPAIGN ON PAIN MANAGEMENT. 

22 ‘‘(a) ESTABLISHMENT.—Not later than June 30, 

23 2010, the Secretary shall establish and implement a na24 tional pain care education outreach and awareness cam25 paign described in subsection (b). 


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1 ‘‘(b) REQUIREMENTS.—The Secretary shall design 

2 the public awareness campaign under this section to edu3 cate consumers, patients, their families, and other care4 givers with respect to— 

5 ‘‘(1) the incidence and importance of pain as a 

6 national public health problem; 

7 ‘‘(2) the adverse physical, psychological, emo8 tional, societal, and financial consequences that can 

9 result if pain is not appropriately assessed, diag10 nosed, treated, or managed; 

11 ‘‘(3) the availability, benefits, and risks of all 

12 pain treatment and management options; 

13 ‘‘(4) having pain promptly assessed, appro14 priately diagnosed, treated, and managed, and regu15 larly reassessed with treatment adjusted as needed; 

16 ‘‘(5) the role of credentialed pain management 

17 specialists and subspecialists, and of comprehensive 

18 interdisciplinary centers of treatment expertise; 

19 ‘‘(6) the availability in the public, nonprofit, 

20 and private sectors of pain management-related in21 formation, services, and resources for consumers, 

22 employers, third-party payors, patients, their fami23 lies, and caregivers, including information on— 


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1 ‘‘(A) appropriate assessment, diagnosis, 

2 treatment, and management options for all 

3 types of pain and pain-related symptoms; and 

4 ‘‘(B) conditions for which no treatment op5 tions are yet recognized; and 

6 ‘‘(7) other issues the Secretary deems appro7 priate. 

8 ‘‘(c) CONSULTATION.—In designing and imple9 menting the public awareness campaign required by this 

10 section, the Secretary shall consult with organizations rep11 resenting patients in pain and other consumers, employ12 ers, physicians including physicians specializing in pain 

13 care, other pain management professionals, medical device 

14 manufacturers, and pharmaceutical companies. 

15 ‘‘(d) COORDINATION.— 

16 ‘‘(1) LEAD OFFICIAL.—The Secretary shall des17 ignate one official in the Department of Health and 

18 Human Services to oversee the campaign established 

19 under this section. 

20 ‘‘(2) AGENCY COORDINATION.—The Secretary 

21 shall ensure the involvement in the public awareness 

22 campaign under this section of the Surgeon General 

23 of the Public Health Service, the Director of the 

24 Centers for Disease Control and Prevention, and 

25 such other representatives of offices and agencies of 


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1 the Department of Health and Human Services as 

2 the Secretary determines appropriate. 

3 ‘‘(e) UNDERSERVED AREAS AND POPULATIONS.—In 

4 designing the public awareness campaign under this sec5 tion, the Secretary shall— 

6 ‘‘(1) take into account the special needs of geo7 graphic areas and racial, ethnic, gender, age, and 

8 other demographic groups that are currently under9 served; and 

10 ‘‘(2) provide resources that will reduce dispari11 ties in access to appropriate diagnosis, assessment, 

12 and treatment. 

13 ‘‘(f) GRANTS AND CONTRACTS.—The Secretary may 

14 make awards of grants, cooperative agreements, and con15 tracts to public agencies and private nonprofit organiza16 tions to assist with the development and implementation 

17 of the public awareness campaign under this section. 

18 ‘‘(g) EVALUATION AND REPORT.—Not later than the 

19 end of fiscal year 2012, the Secretary shall prepare and 

20 submit to the Congress a report evaluating the effective21 ness of the public awareness campaign under this section 

22 in educating the general public with respect to the matters 

23 described in subsection (b). 

24 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For 

25 purposes of carrying out this section, there are authorized 


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1 to be appropriated $2,000,000 for fiscal year 2010 and 

2 $4,000,000 for each of fiscal years 2011 through 2012.’’. 

3 Subtitle F—Coordinated Environ4 mental Public Health Network 

5 SEC. 351. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

6 ACT. 

7 The Public Health Service Act (42 U.S.C. 201 et 

8 seq.), as amended by section 332, is further amended by 

9 adding at the end the following: 

10 ‘‘TITLE XXXIV—COORDINATED 

11 ENVIRONMENTAL PUBLIC 

12 HEALTH NETWORK 

13 ‘‘SEC. 3400. DEFINITIONS. 

14 ‘‘In this title: 

15 ‘‘(1) ADMINISTRATOR.—The term ‘Adminis16 trator’ means the Administrator of the Environ17 mental Protection Agency. 

18 ‘‘(2) COORDINATED NETWORK.—The term ‘Co19 ordinated Network’ means the Coordinated Environ20 mental Public Health Network established under 

21 section 3401(a). 

22 ‘‘(3) DIRECTOR.—The term ‘Director’ means 

23 the Director of the Centers for Disease Control and 

24 Prevention. 


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1 ‘‘(4) DIRECTOR OF CENTER.—The term ‘Direc2 tor of Center’ means the Director of the National 

3 Center for Environmental Health at the Centers for 

4 Disease Control and Prevention. 

5 ‘‘(5) MEDICAL PRIVACY REGULATIONS.—The 

6 term ‘medical privacy regulations’ means the regula7 tions promulgated under section 264(c) of the 

8 Health Insurance Portability and Accountability Act 

9 of 1996. 

10 ‘‘(6) PRIORITY CHRONIC CONDITIONS AND

11 HEALTH EFFECTS.—The term ‘priority chronic con12 ditions and health effects’ means the conditions, as 

13 specified by the Secretary, to be tracked in the Co14 ordinated Network and the State Networks. 

15 ‘‘(7) STATE NETWORK.—The term ‘State Net16 work’ means a State Environmental Public Health 

17 Network established under section 3401(b). 

18 ‘‘(8) STATE.—The term ‘State’ means a State, 

19 local government, territory, or Indian tribe that is 

20 eligible to receive a health tracking grant under sec21 tion 3401(b). 


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1 ‘‘SEC. 3401. ESTABLISHMENT OF COORDINATED AND STATE 

2 ENVIRONMENTAL PUBLIC HEALTH NET3 WORKS. 

4 ‘‘(a) COORDINATED ENVIRONMENTAL PUBLIC

5 HEALTH NETWORK.—Not later than 36 months after the 

6 date of the enactment of this title, the Secretary, acting 

7 through the Director, in consultation with the Adminis8 trator and the Director of Center, and with the involve9 ment of other Federal agencies, and State and local health 

10 departments, shall establish and operate a Coordinated 

11 Environmental Public Health Network. In establishing 

12 and operating the Coordinated Network, the Secretary 

13 shall, as practicable— 

14 ‘‘(1) identify, build upon, expand, and coordi15 nate among existing data and surveillance systems, 

16 surveys, registries, and other Federal public health 

17 and environmental infrastructure as practicable; 

18 ‘‘(2) provide for public access to an electronic 

19 national database that accepts data from the State 

20 Networks on the incidence and prevalence of priority 

21 chronic conditions and health effects and relevant 

22 environmental and other factors, in a manner which 

23 protects personal privacy consistent with the medical 

24 privacy regulations; 

25 ‘‘(3) prepare, publish, and submit to Con26 gress— 


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1 ‘‘(A) not later than 12 months after the 

2 date of enactment of this title, and annually 

3 thereafter, a Coordinated Network Status Re4 port, including a statement of the activities car5 ried out under this title, the identification of 

6 gaps in the data of the coordinated Network, 

7 including diseases of concern and environmental 

8 exposures not tracked, and identification of key 

9 milestones achieved in the preceding year, with 

10 such report to be made available to the public 

11 on the websites of the Centers for Disease Con12 trol and Prevention and the Environmental 

13 Protection Agency; and 

14 ‘‘(B) not later than 2 years after the date 

15 of enactment of this title, and biennially there16 after, a Coordinated Network Health and Envi17 ronment Report, including a statement of the 

18 activities carried out under this title, an anal19 ysis of the most currently available incidence, 

20 prevalence, and trends of priority chronic condi21 tions and health effects, and potentially relevant 

22 environmental and other factors, by State and, 

23 as practicable by local areas, and recommenda24 tions regarding high risk populations, public 

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1 gies, and additional tracking needs, in order to 

2 allow the public to access and understand infor3 mation about environmental health at the Fed4 eral, State, and, where practicable, local level; 

5 ‘‘(4) provide for the establishment of State Net6 works, and coordinate the State Networks as pro7 vided for under subsection (b); 

8 ‘‘(5) provide technical assistance to support the 

9 State Networks; 

10 ‘‘(6) not later than 12 months after the date of 

11 the enactment of this title, develop minimum stand12 ards and procedures for data collection and report13 ing for the State Networks, to be updated not less 

14 than annually thereafter; and 

15 ‘‘(7) in developing the minimum standards and 

16 procedures under subparagraph (F), include mecha17 nisms for allowing the States to set priorities, and 

18 allocate resources accordingly. 

19 ‘‘(b) STATE ENVIRONMENTAL PUBLIC HEALTH NET20 WORKS.— 

21 ‘‘(1) GRANTS.—Not later than 12 months after 

22 the date of the enactment of this title, the Secretary, 

23 acting through the Director, in consultation with the 

24 Administrator and the Director of Center shall 

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1 tenance, and operation of State Networks in accord2 ance with the minimum standards and procedures 

3 established by the Secretary under subsection (a)(3). 

4 ‘‘(2) SPECIALIZED ASSISTANCE.—The Coordi5 nated Network shall provide specialized assistance to 

6 grantees in the establishment, maintenance, and op7 eration of State Networks. 

8 ‘‘(3) REQUIREMENTS.—A State receiving a 

9 grant under this subsection shall use the grant— 

10 ‘‘(A) to establish an environmental public 

11 health network that will provide— 

12 ‘‘(i) for the tracking of the incidence, 

13 prevalence, and trends of priority chronic 

14 conditions and health effects, as well as 

15 any additional priority chronic conditions 

16 and health effects and potentially related 

17 environmental exposures of concern to that 

18 State; 

19 ‘‘(ii) for identification of priority 

20 chronic conditions and health effects and 

21 potentially relevant environmental and 

22 other factors that disproportionately im23 pact low income and minority communities; 

24 ‘‘(iii) for the protection of the con25 fidentiality of all personal data reported, in 


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1 accordance with the medical privacy regu2 lations; 

3 ‘‘(iv) a means by which confidential 

4 data may, in accordance with Federal and 

5 State law, be disclosed to researchers for 

6 the purposes of public health research; 

7 ‘‘(v) the fullest possible public access 

8 to data collected by the State Network or 

9 through the Coordinated Network, while 

10 ensuring that individual privacy is pro11 tected in accordance with subsection 

12 (a)(1)(B); and 

13 ‘‘(vi) for the collection of exposure 

14 data through biomonitoring and other 

15 methods, which may include the entering 

16 into of cooperative agreements as described 

17 in section 3404; 

18 ‘‘(B) to develop a publicly available plan 

19 for establishing the State Network in order to 

20 meet minimum standards and procedures as de21 veloped by the Secretary under subsection 

22 (a)(1)(F); 

23 ‘‘(C) to appoint a lead public health de24 partment or agency that will be responsible for 

25 the development, operation, and maintenance of 


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1 the State Network, and ensure the appropriate 

2 coordination among State and local agencies, 

3 including environmental agencies, regarding the 

4 development, operation, and maintenance of the 

5 State Network; and 

6 ‘‘(D) to recruit and train public health of7 ficials to continue to expand the State Network. 

8 ‘‘(4) LIMITATION.—A State that receives a 

9 grant under this section may not use more than 10 

10 percent of the funds made available through the 

11 grant for administrative costs. 

12 ‘‘(5) APPLICATION.—To seek a grant under this 

13 section, a State shall submit to the Secretary an ap14 plication at such time, in such form and manner, 

15 and accompanied by such information as the Sec16 retary may specify. 

17 ‘‘(c) PILOT PROJECTS.— 

18 ‘‘(1) IN GENERAL.—A State may apply for a 

19 grant under this subsection to implement a pilot 

20 project that is approved by the Secretary, acting 

21 through the Director and in consultation with the 

22 Administrator, and the Director of Center. 

23 ‘‘(2) ACTIVITIES.—A State shall use amounts 

24 received under a grant under this subsection to 

25 carry out a pilot project designed to develop State 


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1 Network enhancements and to develop programs to 

2 address specific local and regional concerns. 

3 ‘‘(3) RESULTS.—The Secretary may consider 

4 the results of the pilot projects under this subsection 

5 for inclusion into the Coordinated Network. 

6 ‘‘(d) PRIVACY.—In establishing and operating the 

7 Coordinated Network under subsection (a), and in making 

8 grants under subsections (b) and (c), the Secretary shall 

9 ensure the protection of privacy of individually identifiable 

10 health information, including ensuring protection con11 sistent with the regulations promulgated under section 

12 264(c) of the Health Insurance Portability and Account13 ability Act of 1996 (42 U.S.C. 1320d–2 note). 

14 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

15 is authorized to be appropriated to carry out this section 

16 such sums as may be necessary for each of fiscal years 

17 2010 through 2014. 

18 ‘‘SEC. 3402. INCREASING PUBLIC HEALTH PERSONNEL CA19 PACITY. 

20 ‘‘(a) IN GENERAL.—Beginning in fiscal year 2010, 

21 the Secretary, acting through the Director, shall enter into 

22 a cooperative agreement with the Council of State and 

23 Territorial Epidemiologists to train and place, in State 

24 and local health departments, applied epidemiology fellows 

25 to enhance State and local public health capacity in the 


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1 areas of environmental health, chronic and other noninfec2 tious diseases and conditions, and public health surveil3 lance. 

4 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

5 is authorized to be appropriated to carry out this section 

6 such sums as may be necessary for each of fiscal years 

7 2010 through 2014. 

8 ‘‘SEC. 3403. GENERAL PROVISION. 

9 ‘‘The Secretary shall integrate the enactment of this 

10 title with all environmental health tracking programs 

11 funded prior to the date of enactment of this title, includ12 ing by integrating the programs, in existence on the date 

13 of enactment of this title, to develop State Network en14 hancements and to develop programs to address specific 

15 local and regional concerns. 

16 ‘‘SEC. 3404. EXPANSION OF BIOMONITORING CAPABILITIES 

17 AND DATA COLLECTION. 

18 ‘‘(a) PURPOSE.—It is the purpose of this section to 

19 expand the scope and amount of biomonitoring data col20 lected and analyzed by the Centers for Disease Control 

21 and Prevention, State laboratories, and consortia of State 

22 laboratories, in order to obtain robust information, includ23 ing information by geographically defined areas and sub24 populations, about a range of environmental exposures. 


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1 ‘‘(b) IN GENERAL.—In meeting the purpose of this 

2 section, the Secretary shall ensure that biomonitoring data 

3 are collected intramurally through appropriate sources, in4 cluding the National Health and Nutrition Examination 

5 Survey, and extramurally shall enter into collaboration or 

6 partnerships with other entities to obtain additional infor7 mation regarding vulnerable subpopulations or other sub8 populations. 

9 ‘‘(c) COOPERATIVE AGREEMENTS.— 

10 ‘‘(1) IN GENERAL.—The Secretary, acting 

11 through the Director, shall enter into cooperative 

12 agreements with States or consortia of States to 

13 support the purposes of this title. 

14 ‘‘(2) APPLICATIONS.—Applications for such co15 operative agreements by consortia of States shall ad16 dress the manner in which such States will coordi17 nate activities with other States in the region, and 

18 shall designate a lead State for administrative pur19 poses. 

20 ‘‘(3) TRAINING AND QUALITY ASSURANCE.— 

21 The Secretary, acting through the Director, shall 

22 through the cooperative agreements with States or a 

23 consortia of States provide laboratory training and 

24 quality assurance. 


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1 ‘‘(d) PRIVACY.—In carrying out this section, the Sec2 retary shall ensure the protection of privacy of individually 

3 identifiable health information, including ensuring protec4 tion consistent with the regulations promulgated under 

5 section 264(c) of the Health Insurance Portability and Ac6 countability Act of 1996 (42 U.S.C. 1320d–2 note). 

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

8 is authorized to be appropriated to carry out this section 

9 such sums as may be necessary for each of fiscal years 

10 2010 through 2014.’’. 

11 Subtitle G—Miscellaneous 

12 Provisions 

13 SEC. 361. SENSE OF THE SENATE CONCERNING CBO SCOR14 ING. 

15 (a) FINDING.—The Senate finds that the costs of 

16 prevention programs are difficult to estimate due in part 

17 because prevention initiatives are hard to measure and re18 sults may occur outside the 5 and 10 year budget win19 dows. 

20 (b) SENSE OF CONGRESS.—It is the sense of the Sen21 ate that Congress should work with the Congressional 

22 Budget Office to develop better methodologies for scoring 

23 progress to be made in prevention and wellness programs. 


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1 SEC. 362. EFFECTIVENESS OF FEDERAL HEALTH AND 

2 WELLNESS INITIATIVES. 

3 To determine whether existing Federal health and 

4 wellness initiatives are effective in achieving their stated 

5 goals, the Secretary of Health and Human Services 

6 shall— 

7 (1) conduct an evaluation of such programs as 

8 they relate to changes in health status of the Amer9 ican public and specifically on the health status of 

10 the Federal workforce, including absenteeism of em11 ployees, the productivity of employees, the rate of 

12 workplace injury, and the medical costs incurred by 

13 employees, and health conditions, including work14 place fitness, healthy food and beverages, and incen15 tives in the Federal Employee Health Benefits Pro16 gram; and 

17 (2) submit to Congress a report concerning 

18 such evaluation, which shall include conclusions con19 cerning the reasons that such existing programs 

20 have proven successful or not successful and what 

21 factors contributed to such conclusions. 


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1 TITLE IV—HEALTH CARE 

2 WORKFORCE 

3 Subtitle A—Purpose and 

4 Definitions 

5 SEC. 401. PURPOSE. 

6 The purpose of this title is to improve access to and 

7 the delivery of health care services for all individuals, par8 ticularly low income, underserved, uninsured, minority, 

9 health disparity, and rural populations by— 

10 (1) gathering and assessing comprehensive data 

11 in order for the health care workforce to meet the 

12 health care needs of individuals, including research 

13 on the supply, demand, distribution, diversity, and 

14 skills needs of the health care workforce; 

15 (2) increasing the supply of a qualified health 

16 care workforce to improve access to and the delivery 

17 of health care services for all individuals; 

18 (3) enhancing health care workforce education 

19 and training to improve access to and the delivery 

20 of health care services for all individuals; and 

21 (4) providing support to the existing health care 

22 workforce to improve access to and the delivery of 

23 health care services for all individuals. 

24 SEC. 402. DEFINITIONS. 

25 (a) THIS TITLE.—In this title: 


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1 (1) HEALTH CARE CAREER PATHWAY.—The 

2 term ‘‘healthcare career pathway’’ means a rigorous, 

3 engaging, and high quality set of courses and serv4 ices that— 

5 (A) includes an articulated sequence of 

6 academic and career courses, including 21st 

7 century skills; 

8 (B) is aligned with the needs of healthcare 

9 industries in a region or State; 

10 (C) prepares students for entry into the 

11 full range of postsecondary education options, 

12 including registered apprenticeships, and ca13 reers; 

14 (D) provides academic and career coun15 seling in student-to-counselor ratios that allow 

16 students to make informed decisions about aca17 demic and career options; 

18 (E) meets State academic standards, State 

19 requirements for secondary school graduation 

20 and is aligned with requirements for entry into 

21 postsecondary education, and applicable indus22 try standards; and 

23 (F) leads to 2 or more credentials, includ24 ing— 

25 (i) a secondary school diploma; and 


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1 (ii) a postsecondary degree, an ap2 prenticeship or other occupational certifi3 cation, a certificate, or a license. 

4 (2) INSTITUTION OF HIGHER EDUCATION.—The 

5 term ‘‘institution of higher education’’ has the 

6 meaning given the term in sections 101 and 102 of 

7 the Higher Education Act of 1965 (20 U.S.C. 1001 

8 and 1002). 

9 (3) LOW INCOME INDIVIDUAL, STATE WORK10 FORCE INVESTMENT BOARD, AND LOCAL WORK11 FORCE INVESTMENT BOARD.—The terms ‘‘low-in12 come individual’’, ‘‘State workforce investment 

13 board’’, and ‘‘local workforce investment board’’, 

14 have the meanings given the terms in section 101 of 

15 the Workforce investment Act of 1998 (29 U.S.C. 

16 2801). 

17 (4) POSTSECONDARY EDUCATION.—The term 

18 ‘‘postsecondary education’’ means— 

19 (A) a 4-year program of instruction, or not 

20 less than a 1-year program of instruction that 

21 is acceptable for credit toward an associate or 

22 a baccalaureate degree, offered by an institution 

23 of higher education; or 

24 (B) a certificate or registered apprentice25 ship program at the postsecondary level offered 


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1 by an institution of higher education or a non2 profit educational institution. 

3 (5) REGISTERED APPRENTICESHIP PROGRAM.— 

4 The term ‘‘registered apprenticeship program’’ 

5 means an industry skills training program at the 

6 postsecondary level that combines technical and the7 oretical training through structure on the job learn8 ing with related instruction (in a classroom or 

9 through distance learning) while an individual is em10 ployed, working under the direction of qualified per11 sonnel or a mentor, and earning incremental wage 

12 increases aligned to enhance job proficiency, result13 ing in the acquisition of a nationally recognized and 

14 portable certificate, under a plan approved by the 

15 Office of Apprenticeship or a State agency recog16 nized by the Department of Labor. 

17 (b) TITLE VII OF THE PUBLIC HEALTH SERVICE

18 ACT.—Section 799B of the Public Health Service Act (42 

19 U.S.C. 295p) is amended— 

20 (1) by striking paragraph (3) and inserting the 

21 following: 

22 ‘‘(3) PHYSICIAN ASSISTANT EDUCATION PRO23 GRAM.—The term ‘physician assistant education 

24 program’ means an educational program in a public 

25 or private institution in a State that— 


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1 ‘‘(A) has as its objective the education of 

2 individuals who, upon completion of their stud3 ies in the program, be qualified to provide pri4 mary care medical services with the supervision 

5 of a physician; and 

6 ‘‘(B) is accredited by the Accreditation Re7 view Commission on Education for the Physi8 cian Assistant.’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(12) AREA HEALTH EDUCATION CENTER.— 

11 The term ‘area health education center’ means a 

12 public or nonprofit private organization that has a 

13 cooperative agreement or contract in effect with an 

14 entity that has received an award under subsection 

15 (b) or (c) of section 751, satisfies the requirements 

16 in section 751(d)(1), and has as one of its principal 

17 functions the operation of an area health education 

18 center. Appropriate organizations may include hos19 pitals, health organizations with accredited primary 

20 care training programs, accredited physician assist21 ant educational programs associated with a college 

22 or university, and universities or colleges not oper23 ating a school of medicine or osteopathic medicine. 

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1 gram’ means cooperative program consisting of an 

2 entity that has received an award under subsection 

3 (b) or (c) of section 751 for the purpose of planning, 

4 developing, operating, and evaluating an area health 

5 education center program and one or more area 

6 health education centers, which carries out the re7 quired activities described in subsection (b)(4) or 

8 (c)(4) of section 751, satisfies the program require9 ments in such section, has as one of its principal 

10 functions identifying and implementing strategies 

11 and activities that address health care workforce 

12 needs in its service area, in coordination with the 

13 local workforce investment boards. 

14 ‘‘(14) CLINICAL SOCIAL WORKER.—The term 

15 ‘clinical social worker’ has the meaning given the 

16 term in section 1861(hh)(1) of the Social Security 

17 Act (42 U.S.C. 1395x(hh)(1)). 

18 ‘‘(15) CULTURAL COMPETENCY.—The term 

19 ‘cultural competency’ shall be defined by the Sec20 retary in a manner consistent with section 

21 1707(d)(3). 

22 ‘‘(16) DIRECT CARE WORKER.—The term ‘di23 rect care worker’ has the meaning given that term 

24 in the 2010 Standard Occupational Classifications of 

25 the Department of Labor for Home Health Aides 


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1 [31–1011], Psychiatric Aides [31–1013], Nursing 

2 Assistants [31–1014], and Personal Care Aides [39– 

3 9021]. 

4 ‘‘(17) FEDERALLY QUALIFIED HEALTH CEN5 TER.—The term ‘Federally qualified health center’ 

6 has the meaning given that term in section 1861(aa) 

7 of the Social Security Act (42 U.S.C. 1395x(aa)). 

8 ‘‘(18) FRONTIER HEALTH PROFESSIONAL

9 SHORTAGE AREA.—The term ‘frontier health profes10 sional shortage area’ means an area— 

11 ‘‘(A) with a population density less than 6 

12 persons per square mile within the service area; 

13 and 

14 ‘‘(B) with respect to which the distance or 

15 time for the population to access care is exces16 sive. 

17 ‘‘(19) GRADUATE PSYCHOLOGY.—The term 

18 ‘graduate psychology’ means an accredited program 

19 in professional psychology. 

20 ‘‘(20) HEALTH DISPARITY POPULATION.—The 

21 term ‘health disparity population’ has the meaning 

22 given such term in section 903(d)(1). 

23 ‘‘(21) HEALTH LITERACY.—The term ‘health 

24 literacy’ means the degree to which an individual has 

25 the capacity to obtain, communicate, process, and 


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1 understand health information and services in order 

2 to make appropriate health decisions. 

3 ‘‘(22) MENTAL HEALTH SERVICE PROFES4 SIONAL.—The term ‘mental health service profes5 sional’ means an individual with a graduate or post6 graduate degree from an accredited institution of 

7 higher education in psychiatry, psychology, school 

8 psychology, behavioral pediatrics, psychiatric nurs9 ing, social work, school social work, substance abuse 

10 disorder prevention and treatment, marriage and 

11 family counseling, school counseling, or professional 

12 counseling. 

13 ‘‘(23) ONE-STOP DELIVERY SYSTEM CENTER.— 

14 The term ‘one-stop delivery system’ means a one15 stop delivery system described in section 134(c) of 

16 the Workforce Investment Act of 1998 (29 U.S.C. 

17 2864(c)). 

18 ‘‘(24) PARAPROFESSIONAL CHILD AND ADOLES19 CENT MENTAL HEALTH WORKER.—The term ‘para20 professional child and adolescent mental health 

21 worker’ means an individual who is not a mental or 

22 behavioral health service professional, but who works 

23 at the first stage of contact with children and fami24 lies who are seeking mental or behavioral health 


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1 services, including substance abuse prevention and 

2 treatment services. 

3 ‘‘(25) RACIAL AND ETHNIC MINORITY GROUP; 

4 RACIAL AND ETHNIC MINORITY POPULATION.—The 

5 terms ‘racial and ethnic minority group’ and ‘racial 

6 and ethnic minority population’ have the meaning 

7 given the term ‘racial and ethnic minority group’ in 

8 section 1707. 

9 ‘‘(26) RURAL HEALTH CLINIC.—The term 

10 ‘rural health clinic’ has the meaning given that term 

11 in section 1861(aa) of the Social Security Act (42 

12 U.S.C. 1395x(aa)).’’. 

13 (c) TITLE VIII OF THE PUBLIC HEALTH SERVICE

14 ACT.—Section 801 of the Public Health Service Act (42 

15 U.S.C. 296) is amended— 

16 (1) in paragraph (2)— 

17 (A) by striking ‘‘means a’’ and inserting 

18 ‘‘means an accredited (as defined in paragraph 

19 6)’’; and 

20 (B) by striking the period as inserting the 

21 following: ‘‘where graduates are— 

22 ‘‘(A) authorized to sit for the National 

23 Council Licensure EXamination-Registered 

24 Nurse (NCLEX-RN); or 


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1 ‘‘(B) licensed registered nurses who will re2 ceive a graduate or equivalent degree or train3 ing to become an advanced education nurse as 

4 defined by section 811(b).’’; and 

5 (2) by adding at the end the following: 

6 ‘‘(16) ACCELERATED NURSING DEGREE PRO7 GRAM.—The term ‘accelerated nursing degree pro8 gram’ means a program of education in professional 

9 nursing offered by an accredited school of nursing in 

10 which an individual holding a bachelors degree in 

11 another discipline receives a BSN or MSN degree in 

12 an accelerated time frame as determined by the ac13 credited school of nursing. 

14 ‘‘(17) BRIDGE OR DEGREE COMPLETION PRO15 GRAM.—The term ‘bridge or degree completion pro16 gram’ means a program of education in professional 

17 nursing offered by an accredited school of nursing, 

18 as defined in paragraph (2), that leads to a bacca19 laureate degree in nursing. Such programs may in20 clude, Registered Nurse (RN) to Bachelor’s of 

21 Science of Nursing (BSN) programs, RN to MSN 

22 (Master of Science of Nursing) programs, or BSN to 

23 Doctoral programs.’’. 


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1 Subtitle B—Innovations in the 

2 Health Care Workforce 

3 SEC. 411. NATIONAL HEALTH CARE WORKFORCE COMMIS4 SION. 

5 (a) PURPOSE.—It is the purpose of this section to 

6 establish a National Health Care Workforce Commission 

7 that— 

8 (1) serves as a national resource for Congress, 

9 the President, States, and localities by— 

10 (A) disseminating information on current 

11 and projected health care workforce supply and 

12 demand; 

13 (B) disseminating information on health 

14 care workforce education and training capacity 

15 and instruction or delivery models and best 

16 practices; 

17 (C) recognizing efforts of Federal, State, 

18 and local partnerships to develop and offer 

19 health care career pathways of proven effective20 ness; 

21 (D) disseminating information on prom22 ising retention practices for health care profes23 sionals; 

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1 cruitment, education and training, and reten2 tion of the health care workforce; and 

3 (F) disseminating recommendations on the 

4 development of a fiscally sustainable integrated 

5 workforce that supports a high-quality health 

6 care delivery system that meets the needs of pa7 tients and populations; 

8 (2) communicates and coordinates with the De9 partments of Health and Human Services, Labor, 

10 Veterans Affairs, Homeland Security, and Education 

11 on related activities administered by one or more of 

12 such Departments; 

13 (3) develops and commissions evaluations of 

14 education and training activities to determine wheth15 er the demand for health care workers is being met; 

16 (4) identifies barriers to improved coordination 

17 at the Federal, State, and local levels and rec18 ommend ways to address such barriers; and 

19 (5) encourages innovations to address popu20 lation needs, constant changes in technology, and 

21 other environmental factors. 

22 (b) ESTABLISHMENT.—There is hereby established 

23 the National Health Care Workforce Commission (in this 

24 section referred to as the ‘‘Commission’’). 

25 (c) MEMBERSHIP.— 


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1 (1) NUMBER AND APPOINTMENT.—The Com2 mission shall be composed of 15 members to be ap3 pointed by the Comptroller General, without regard 

4 to section 5 of the Federal Advisory Committee Act 

5 (5 U.S.C. App.). 

6 (2) QUALIFICATIONS.— 

7 (A) IN GENERAL.—The membership of the 

8 Commission shall include individuals— 

9 (i) with national recognition for their 

10 expertise in health care labor market anal11 ysis, including health care workforce anal12 ysis; health care finance and economics; 

13 health care facility management; health 

14 care plans and integrated delivery systems; 

15 health care workforce education and train16 ing; health care philanthropy; providers of 

17 health care services; and other related 

18 fields; and 

19 (ii) who will provide a combination of 

20 professional perspectives, broad geographic 

21 representation, and a balance between 

22 urban, suburban, rural, and frontier rep23 resentatives. 

24 (B) INCLUSION.— 


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1 (i) IN GENERAL.—The membership of 

2 the Commission shall include no less than 

3 one representative of— 

4 (I) the health care workforce and 

5 health professionals; 

6 (II) employers; 

7 (III) third-party payers; 

8 (IV) individuals skilled in the 

9 conduct and interpretation of health 

10 care services and health economics re11 search; 

12 (V) representatives of consumers; 

13 (VI) labor unions; 

14 (VII) State or local workforce in15 vestment boards; and 

16 (VIII) educational institutions 

17 (which may include elementary and 

18 secondary institutions, institutions of 

19 higher education, including 2 and 4 

20 year institutions, or registered ap21 prenticeship programs). 

22 (ii) ADDITIONAL MEMBERS.—The re23 maining membership may include addi24 tional representatives from clause (i) and 

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1 priate by the Comptroller General of the 

2 United States. 

3 (C) MAJORITY NON-PROVIDERS.—Individ4 uals who are directly involved in health profes5 sions education or practice shall not constitute 

6 a majority of the membership of the Commis7 sion. 

8 (D) ETHICAL DISCLOSURE.—The Comp9 troller General shall establish a system for pub10 lic disclosure by members of the Commission of 

11 financial and other potential conflicts of interest 

12 relating to such members. Members of the 

13 Commission shall be treated as employees of 

14 Congress for purposes of applying title I of the 

15 Ethics in Government Act of 1978. Members of 

16 the Commission shall not be treated as special 

17 government employees under title 18, United 

18 States Code. 

19 (3) TERMS.— 

20 (A) IN GENERAL.—The terms of members 

21 of the Commission shall be for 3 years except 

22 that the Comptroller General shall designate 

23 staggered terms for the members first ap24 pointed. 


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1 (B) VACANCIES.—Any member appointed 

2 to fill a vacancy occurring before the expiration 

3 of the term for which the member’s predecessor 

4 was appointed shall be appointed only for the 

5 remainder of that term. A member may serve 

6 after the expiration of that members term until 

7 a successor has taken office. A vacancy in the 

8 Commission shall be filled in the manner in 

9 which the original appointment was made. 

10 (C) INITIAL APPOINTMENTS.—The Comp11 troller General shall make initial appointments 

12 of members to the Commission not later than 

13 September 30, 2010. 

14 (4) COMPENSATION.—While serving on the 

15 business of the Commission (including travel time), 

16 a member of the Commission shall be entitled to 

17 compensation at the per diem equivalent of the rate 

18 provided for level IV of the Executive Schedule 

19 under section 5315 of tile 5, United States Code, 

20 and while so serving away from home and the mem21 ber’s regular place of business, a member may be al22 lowed travel expenses, as authorized by the Chair23 man of the Commission. Physicians serving as per24 sonnel of the Commission may be provided a physi25 cian comparability allowance by the Commission in 


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1 the same manner as Government physicians may be 

2 provided such an allowance by an agency under sec3 tion 5948 of title 5, United States Code, and for 

4 such purpose subsection (i) of such section shall 

5 apply to the Commission in the same manner as it 

6 applies to the Tennessee Valley Authority. For pur7 poses of pay (other than pay of members of the 

8 Commission) and employment benefits, rights, and 

9 privileges, all personnel of the Commission shall be 

10 treated as if they were employees of the United 

11 States Senate. Personnel of the Commission shall 

12 not be treated as employees of the Government Ac13 countability Office for any purpose. 

14 (5) CHAIRMAN, VICE CHAIRMAN.—The Comp15 troller General shall designate a member of the 

16 Commission, at the time of appointment of the mem17 ber, as Chairman and a member as Vice Chairman 

18 for that term of appointment, except that in the case 

19 of vacancy of the chairmanship or vice chairman20 ship, the Comptroller General may designate another 

21 member for the remainder of that member’s term. 

22 (6) MEETINGS.—The Commission shall meet at 

23 the call of the chairman, but no less frequently than 

24 on a quarterly basis. 

25 (d) DUTIES.— 


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1 (1) REVIEW OF HEALTH CARE WORKFORCE

2 AND ANNUAL REPORTS.—In order to develop a fis3 cally sustainable integrated workforce that supports 

4 a high-quality, readily accessible health care delivery 

5 system that meets the needs of patients and popu6 lations, the Commission, in consultation with rel7 evant Federal, State, and local agencies, shall— 

8 (A) review current and projected health 

9 care workforce supply and demand, including 

10 the topics described in paragraph (2); 

11 (B) make recommendations to Congress 

12 and the Administration concerning national 

13 health care workforce priorities, goals, and poli14 cies; 

15 (C) by not later than October 1 of each 

16 year (beginning with 2011), submit a report to 

17 Congress and the Administration containing the 

18 results of such reviews and recommendations 

19 concerning related policies; and 

20 (D) by not later than April 1 of each year 

21 (beginning with 2011), submit a report to Con22 gress and the Administration containing a re23 view of, and recommendations on, at a min24 imum one high priority area as described in 

25 paragraph (3). 


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1 (2) SPECIFIC TOPICS TO BE REVIEWED.—The 

2 topics described in this paragraph include— 

3 (A) current health care workforce supply 

4 and distribution, including demographics, skill 

5 sets, and demands, with projected demands 

6 during the subsequent 10 and 25 year periods; 

7 (B) health care workforce education and 

8 training capacity, including the number of stu9 dents who have completed education and train10 ing, including registered apprenticeships; the 

11 number of qualified faculty; the education and 

12 training infrastructure; and the education and 

13 training demands, with projected demands dur14 ing the subsequent 10 and 25 year periods, and 

15 including identified models of education and 

16 training delivery and best practices; 

17 (C) the education loan and grant programs 

18 in titles VII and VIII of the Public Health 

19 Service Act (42 U.S.C. 292 et seq. and 296 et 

20 seq.), with recommendations on whether such 

21 programs should become part of the Higher 

22 Education Act of 1965 (20 U.S.C. 1001 et 

23 seq); 

24 (D) the implications of new and existing 

25 Federal policies which affect the health care 


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1 workforce, including Medicare and Medicaid 

2 graduate medical education policies, titles VII 

3 and VIII of the Public Health Service Act (42 

4 U.S.C. 292 et seq. and 296 et seq.), the Na5 tional Health Service Corps (with recommenda6 tions for aligning such programs with national 

7 health workforce priorities and goals), and 

8 other health care workforce programs, including 

9 those supported through the Workforce Invest10 ment Act of 1998 (29 U.S.C. 2801 et seq.), the 

11 Carl D. Perkins Career and Technical Edu12 cation Act of 2006 (20 U.S.C. 2301 et seq.), 

13 the Higher Education Act of 1965 (20 U.S.C. 

14 1001 et seq.), and any other Federal health 

15 care workforce programs; 

16 (E) the health care workforce needs of spe17 cial populations, such as minorities, rural popu18 lations, medically underserved populations, gen19 der specific needs, individuals with disabilities, 

20 and geriatric and pediatric populations with 

21 recommendations for new and existing Federal 

22 policies to meet the needs of these special popu23 lations; and 

24 (F) recommendations creating or revising 

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1 ship programs to require low-income, minority 

2 medical students to serve in their home commu3 nities, if designated as medical underserved 

4 community. 

5 (3) HIGH PRIORITY AREAS.— 

6 (A) IN GENERAL.—The initial high priority 

7 topics described in this paragraph include— 

8 (i) integrated health care workforce 

9 planning that identifies health care profes10 sional skills needed and maximizes the skill 

11 sets of health care professionals across dis12 ciplines; 

13 (ii) an analysis of the nature, scopes 

14 of practice, and demands for health care 

15 workers in the enhanced information tech16 nology and management workplace; 

17 (iii) Medicare and Medicaid graduate 

18 medical education policies and rec19 ommendations, including increasing direct 

20 payments to community based training 

21 sites and medical training programs, for 

22 aligning with national workforce goals; 

23 (iv) nursing workforce capacity at all 

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1 pacity, projected demands, and integration 

2 within the health care delivery system; 

3 (v) oral health care workforce capac4 ity, including education and training ca5 pacity, projected demands, and integration 

6 within the health care delivery system; 

7 (vi) mental and behavioral health care 

8 workforce capacity, including education 

9 and training capacity, projected demands, 

10 and integration within the health care de11 livery system; 

12 (vii) allied health and public health 

13 care workforce capacity, including edu14 cation and training capacity, projected de15 mands, and integration within the health 

16 care delivery system; 

17 (viii) the geographic distribution of 

18 health care providers as compared to the 

19 identified health care workforce needs of 

20 States and regions; and 

21 (ix) emergency medical service work22 force capacity, including training and the 

23 retention and recruitment of the volunteer 

24 workforce. 


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1 (B) FUTURE DETERMINATIONS.—The 

2 Commission may require that additional topics 

3 be included under subparagraph (A). The ap4 propriate committees of Congress may rec5 ommend to the Commission the inclusion of 

6 other topics for health care workforce develop7 ment areas that require special attention. 

8 (4) GRANT PROGRAM.—The Commission shall 

9 review implementation progress reports on, and re10 port to Congress about, the State Health Care 

11 Workforce Development Grants program established 

12 in section 412. 

13 (5) STUDY.—The Commission shall study effec14 tive mechanisms for financing education and train15 ing for careers in health care, including public health 

16 and allied health. 

17 (6) RECOMMENDATIONS.—The Commission 

18 shall submit recommendations to Congress, the De19 partment of Labor, and the Department of Health 

20 and Human Services about improving safety, health, 

21 and worker protections in the workplace for the 

22 health care workforce. 

23 (7) ASSESSMENT.—The Commission shall as24 sess and receive reports from the National Center 


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1 for Health Care Workforce Analysis established 

2 under title VII of the Public Service Health Act. 

3 (e) CONSULTATION WITH FEDERAL, STATE, AND

4 LOCAL AGENCIES, CONGRESS, AND OTHER ORGANIZA5 TIONS.— 

6 (1) IN GENERAL.—The Commission shall con7 sult with Federal agencies (including the Depart8 ments of Health and Human Services, Labor, Edu9 cation, Commerce, Agriculture, Defense, and Vet10 erans Affairs and the Environmental Protection 

11 Agency), Congress, the Medicare Payment Advisory 

12 Commission, the Medicaid and CHIP Payment and 

13 Access Commission, and, to the extent practicable, 

14 with State and local agencies, Indian tribes, vol15 untary health care organizations, professional soci16 eties, and other relevant public-private health care 

17 partnerships. 

18 (2) OBTAINING OFFICIAL DATA.—The Commis19 sion, consistent with established privacy rules, may 

20 secure directly from any department or agency of 

21 the Executive Branch information necessary to en22 able the Commission to carry out this section. 

23 (3) DETAIL OF FEDERAL GOVERNMENT EM24 PLOYEES.—An employee of the Federal Government 

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1 bursement. The detail of such an employee shall be 

2 without interruption or loss of civil service status. 

3 (f) DIRECTOR AND STAFF; EXPERTS AND CONSULT4 ANTS.—Subject to such review as the Comptroller General 

5 of the United States determines to be necessary to ensure 

6 the efficient administration of the Commission, the Com7 mission may— 

8 (1) employ and fix the compensation of an exec9 utive director that shall not exceed the rate of basic 

10 pay payable for level V of the Executive Schedule 

11 and such other personnel as may be necessary to 

12 carry out its duties (without regard to the provisions 

13 of title 5, United States Code, governing appoint14 ments in the competitive service); 

15 (2) seek such assistance and support as may be 

16 required in the performance of its duties from ap17 propriate Federal departments and agencies; 

18 (3) enter into contracts or make other arrange19 ments, as may be necessary for the conduct of the 

20 work of the Commission (without regard to section 

21 3709 of the Revised Statutes (41 U.S.C. 5)); 

22 (4) make advance, progress, and other pay23 ments which relate to the work of the Commission; 

24 (5) provide transportation and subsistence for 

25 persons serving without compensation; and 


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1 (6) prescribe such rules and regulations as the 

2 Commission determines to be necessary with respect 

3 to the internal organization and operation of the 

4 Commission. 

5 (g) POWERS.— 

6 (1) DATA COLLECTION.—In order to carry out 

7 its functions under this section, the Commission 

8 shall— 

9 (A) utilize existing information, both pub10 lished and unpublished, where possible, collected 

11 and assessed either by its own staff or under 

12 other arrangements made in accordance with 

13 this section, including coordination with the Bu14 reau of Labor Statistics; 

15 (B) carry out, or award grants or con16 tracts for the carrying out of, original research 

17 and development, where existing information is 

18 inadequate, and 

19 (C) adopt procedures allowing interested 

20 parties to submit information for the Commis21 sion’s use in making reports and recommenda22 tions. 

23 (2) ACCESS OF THE GOVERNMENT ACCOUNT24 ABILITY OFFICE TO INFORMATION.—The Comp25 troller General of the United States shall have unreVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00597 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 stricted access to all deliberations, records, and data 

2 of the Commission, immediately upon request. 

3 (3) PERIODIC AUDIT.—The Commission shall 

4 be subject to periodic audit by an independent public 

5 accountant under contract to the Commission. 

6 (h) AUTHORIZATION OF APPROPRIATIONS.— 

7 (1) REQUEST FOR APPROPRIATIONS.—The 

8 Commission shall submit requests for appropriations 

9 in the same manner as the Comptroller General of 

10 the United States submits requests for appropria11 tions. Amounts so appropriated for the Commission 

12 shall be separate from amounts appropriated for the 

13 Comptroller General. 

14 (2) AUTHORIZATION.—There are authorized to 

15 be appropriated such sums as may be necessary to 

16 carry out this section. 

17 (3) GIFTS.—The Commission is authorized to 

18 accept and gifts for purposing of carrying out this 

19 section. 

20 (i) DEFINITIONS.—In this section: 

21 (1) HEALTH CARE WORKFORCE.—The term 

22 ‘‘health care workforce’’ includes all health care pro23 viders with direct patient care and support respon24 sibilities, such as physicians, nurses, nurse practi25 tioners, primary care providers, preventive medicine 


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1 physicians, optometrists, ophthalmologists, physician 

2 assistants, pharmacists, dentists, dental hygienists, 

3 and other oral healthcare professionals, allied health 

4 professionals, doctors of chiropractic, community 

5 health workers, health care paraprofessionals, direct 

6 care workers, psychologists and other behavioral and 

7 mental health professionals (including substance 

8 abuse prevention and treatment providers), social 

9 workers, physical and occupational therapists, cer10 tified nurse midwives, podiatrists, the EMS work11 force (including professional and volunteer ambu12 lance personnel and firefighters who perform emer13 gency medical services), licensed complementary and 

14 alternative medicine providers, integrative health 

15 practitioners, public health professionals, and any 

16 other health professional that the Comptroller Gen17 eral of the United States determines appropriate. 

18 (2) HEALTH PROFESSIONALS.—The term 

19 ‘‘health professionals’’ includes— 

20 (A) dentists, dental hygienists, primary 

21 care providers, specialty physicians, nurses, 

22 nurse practitioners, physician assistants, psy23 chologists and other behavioral and mental 

24 health professionals (including substance abuse 

25 prevention and treatment providers), social 


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1 workers, physical therapists, public health pro2 fessionals, clinical pharmacists, allied health 

3 professionals, doctors of chiropractic, commu4 nity health workers, school nurses, certified 

5 nurse midwives, podiatrists, licensed com6 plementary and alternative medicine providers, 

7 the EMS workforce (including professional and 

8 volunteer ambulance personnel and firefighters 

9 who perform emergency medical services), and 

10 integrative health practitioners; 

11 (B) national representatives of health pro12 fessionals; 

13 (C) representatives of schools of medicine, 

14 osteopathy, nursing, dentistry, optometry, phar15 macy, chiropractic, allied health, educational 

16 programs for public health professionals, behav17 ioral and mental health professionals (as so de18 fined), social workers, pharmacists, physical 

19 therapists, oral health care industry dentistry 

20 and dental hygiene, and physician assistants; 

21 (D) representatives of public and private 

22 teaching hospitals, and ambulatory health facili23 ties, including Federal medical facilities; and 


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1 (E) any other health professional the 

2 Comptroller General of the United States deter3 mines appropriate. 

4 (j) REIMBURSEMENT OF COSTS.—The Commission 

5 shall reimburse the Government Accountability Office for 

6 the full cost of carrying out its activities under this section 

7 as billed therefore by the Comptroller General of the 

8 United States. Such reimbursements shall be credited to 

9 the appropriation account ‘‘Salaries and Expenses, Gov10 ernment Accountability Office’’ current when the payment 

11 is received and remain available until expended. 

12 SEC. 412. STATE HEALTH CARE WORKFORCE DEVELOP13 MENT GRANTS. 

14 (a) ESTABLISHMENT.—There is established a com15 petitive health care workforce development grant program 

16 (referred to in this section as the ‘‘program’’) for the pur17 pose of enabling State partnerships to complete com18 prehensive planning and to carry out activities leading to 

19 coherent and comprehensive health care workforce devel20 opment strategies at the State and local levels. 

21 (b) ASSESSMENT AND REPORTING.— 

22 (1) DUTIES OF COMMISSION.—The National 

23 Health Care Workforce Commission established in 

24 section 411 (referred to in this section as the ‘‘Com25 mission’’) shall— 


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1 (A) in collaboration with the Department 

2 of Labor and in coordination with the Depart3 ment of Education and other relevant Federal 

4 agencies, make recommendations to the fiscal 

5 and administrative agent under paragraph (2) 

6 for grant recipients; 

7 (B) assess the implementation of the 

8 grants; and 

9 (C) collect performance and report infor10 mation, including identified models and best 

11 practices, on grants from the fiscal and admin12 istrative agent and distribute this information 

13 to Congress, relevant Federal agencies, and to 

14 the public. 

15 (2) FISCAL AND ADMINISTRATIVE AGENT.—The 

16 Health Resources and Services Administration of the 

17 Department of Health and Human Services (re18 ferred to in this section as the ‘‘Administration’’) 

19 shall be the fiscal and administrative agent for the 

20 grants awarded under this section. The Administra21 tion is authorized to carry out the program, in con22 sultation with the Commission, which shall review 

23 reports on the development, implementation, and 

24 evaluation activities of the grant program, includ25 ing— 


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1 (A) administering the grants; 

2 (B) providing technical assistance to grant3 ees; and 

4 (C) reporting performance information to 

5 the Commission. 

6 (c) PLANNING GRANTS.— 

7 (1) AMOUNT AND DURATION.—A planning 

8 grant shall be awarded under this subsection for a 

9 period of not more than one year and the maximum 

10 award may not be more than $150,000. 

11 (2) ELIGIBILITY.—To be eligible to receive a 

12 planning grant, an entity shall be an eligible part13 nership. An eligible partnership shall be a State 

14 workforce investment board, if it includes or modi15 fies the members to include at least one representa16 tive from each of the following: health care em17 ployer, labor organization, a public 2-year institution 

18 of higher education, a public 4-year institution of 

19 higher education, the recognized State federation of 

20 labor, the State public secondary education agency, 

21 the State P–16 or P–20 Council if such a council ex22 ists, and a philanthropic organization that is actively 

23 engaged in providing learning, mentoring, and work 

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1 uals for, and retain individuals in, careers in health 

2 care and related industries. 

3 (3) FISCAL AND ADMINISTRATIVE AGENT.—The 

4 Governor of the State receiving a planning grant has 

5 the authority to appoint a fiscal and an administra6 tive agency for the partnership. 

7 (4) APPLICATION.—Each State partnership de8 siring a planning grant shall submit an application 

9 to the Administrator of the Administration at such 

10 time and in such manner, and accompanied by such 

11 information as the Administrator may reasonable re12 quire. Each application submitted for a planning 

13 grant shall describe the members of the State part14 nership, the activities for which assistance is sought, 

15 the proposed performance benchmarks to be used to 

16 measure progress under the planning grant, a budg17 et for use of the funds to complete the required ac18 tivities described in paragraph (5), and such addi19 tional assurance and information as the Adminis20 trator determines to be essential to ensure compli21 ance with the grant program requirements. 

22 (5) REQUIRED ACTIVITIES.—A State partner23 ship receiving a planning grant shall carry out the 

24 following: 


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1 (A) Analyze State labor market informa2 tion in order to create health care career path3 ways for students and adults. 

4 (B) Identify current and projected high de5 mand State or regional health care sectors for 

6 purposes of planning career pathways. 

7 (C) Identify existing Federal, State, and 

8 private resources to recruit, educate or train, 

9 and retain a skilled health care workforce and 

10 strengthen partnerships. 

11 (D) Describe the academic and health care 

12 industry skill standards for high school gradua13 tion, for entry into postsecondary education, 

14 and for various credentials and licensure. 

15 (E) Describe State secondary and postsec16 ondary education and training policies, models, 

17 or practices for the health care sector, including 

18 career information and guidance counseling. 

19 (F) Identify Federal or State policies or 

20 rules to developing a coherent and comprehen21 sive health care workforce development strategy 

22 and barriers and a plan to resolve these bar23 riers. 

24 (G) Participate in the Administration’s 

25 evaluation and reporting activities. 


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1 (6) PERFORMANCE AND EVALUATION.—Before 

2 the State partnership receives a planning grant, 

3 such partnership and the Administrator of the Ad4 ministration shall jointly determine the performance 

5 benchmarks that will be established for the purposes 

6 of the planning grant. 

7 (7) MATCH.—Each State partnership receiving 

8 a planning grant shall provide an amount, in cash 

9 or in kind, that is not less that 15 percent of the 

10 amount of the grant, to carry out the activities sup11 ported by the grant. The matching requirement may 

12 be provided from funds available under other Fed13 eral, State, local or private sources to carry out the 

14 activities. 

15 (8) REPORT.— 

16 (A) REPORT TO ADMINISTRATION.—Not 

17 later than 1 year after a State partnership re18 ceives a planning grant, the partnership shall 

19 submit a report to the Administration on the 

20 State’s performance of the activities under the 

21 grant, including the use of funds, including 

22 matching funds, to carry out required activities, 

23 and a description of the progress of the State 

24 workforce investment board in meeting the per25 formance benchmarks. 


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1 (B) REPORT TO CONGRESS.—The Admin2 istration shall submit a report to Congress ana3 lyzing the planning activities, performance, and 

4 fund utilization of each State grant recipient, 

5 including an identification of promising prac6 tices and a profile of the activities of each State 

7 grant recipient. 

8 (d) IMPLEMENTATION GRANTS.— 

9 (1) IN GENERAL.—The Administration shall— 

10 (A) competitively award implementation 

11 grants to State partnerships to enable such 

12 partnerships to implement activities that will 

13 result in a coherent and comprehensive plan for 

14 health workforce development that will address 

15 current and projected workforce demands with16 in the State; and 

17 (B) inform the Commission and Congress 

18 about the awards made. 

19 (2) DURATION.—An implementation grant shall 

20 be awarded for a period of no more than 2 years, 

21 except in those cases where the Administration de22 termines that the grantee is high performing and the 

23 activities supported by the grant warrant up to 1 ad24 ditional year of funding. 


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1 (3) ELIGIBILITY.—To be eligible for an imple2 mentation grant, a State partnership shall have— 

3 (A) received a planning grant under sub4 section (c) and completed all requirements of 

5 such grant; or 

6 (B) completed a satisfactory application, 

7 including a plan to coordinate with required 

8 partners and complete the required activities 

9 during the 2 year period of the implementation 

10 grant. 

11 (4) FISCAL AND ADMINISTRATIVE AGENT.—A 

12 State partnership receiving an implementation grant 

13 shall appoint a fiscal and an administration agent 

14 for the implementation of such grant. 

15 (5) APPLICATION.—Each eligible State partner16 ship desiring an implementation grant shall submit 

17 an application to the Administration at such time, in 

18 such manner, and accompanied by such information 

19 as the Administration may reasonably require. Each 

20 application submitted shall include— 

21 (A) a description of the members of the 

22 State partnership; 

23 (B) a description of how the State partner24 ship completed the required activities under the 

25 planning grant, if applicable; 


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1 (C) a description of the activities for which 

2 implementation grant funds are sought, includ3 ing grants to regions by the State partnership 

4 to advance coherent and comprehensive regional 

5 health care workforce planning activities; 

6 (D) a description of how the State partner7 ship will coordinate with required partners and 

8 complete the required partnership activities 

9 during the duration of an implementation 

10 grant. 

11 (E) a budget proposal of the cost of the 

12 activities supported by the implementation 

13 grant and a timeline for the provision of match14 ing funds required; 

15 (F) proposed performance benchmarks to 

16 be used to assess and evaluate the progress of 

17 the partnership activities; 

18 (G) a description of how the State partner19 ship will collect data to report progress in grant 

20 activities; and 

21 (H) such additional assurances as the Ad22 ministration determines to be essential to en23 sure compliance with grant requirements. 

24 (6) REQUIRED ACTIVITIES.— 


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1 (A) IN GENERAL.—A State partnership 

2 that receives an implementation grant may re3 serve not less than 60 percent of the grant 

4 funds to make grants to be competitively 

5 awarded by the State partnership, consistent 

6 with State procurement rules, to encourage re7 gional partnerships to address health care 

8 workforce development needs and to promote 

9 innovative health care workforce career pathway 

10 activities, including career counseling, learning, 

11 and employment. 

12 (B) ELIGIBLE PARTNERSHIP DUTIES.—An 

13 eligible State partnership receiving an imple14 mentation grant shall— 

15 (i) identify and convene regional lead16 ership to discuss opportunities to engage in 

17 statewide health care workforce develop18 ment planning, including potential use of 

19 grants to be competitively awarded by the 

20 State partnership to encourage innovative 

21 approaches to improving the supply, diver22 sity, distribution, and development of re23 gional health care workforces, including 

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1 pansion of and access to quality and timely 

2 career information and guidance, and edu3 cation and training programs; 

4 (ii) in consultation with key stake5 holders and regional leaders, take appro6 priate steps to reduce Federal, State, or 

7 local barriers to a comprehensive and co8 herent strategy, including changes in State 

9 or local policies to foster coherent and 

10 comprehensive health care workforce devel11 opment activities, including health care ca12 reer pathways at the State and regional 

13 levels and career planning information, and 

14 as appropriate, requests for Federal pro15 gram or administrative waivers; 

16 (iii) develop and disseminate a pre17 liminary statewide strategy that addresses 

18 short- and long-term health care workforce 

19 development supply versus demand, includ20 ing the solicitation of comments or feed21 back from key stakeholders and the gen22 eral public, and refine accordingly; 

23 (iv) convene State partnership mem24 bers on a regular basis, and at least on a 

25 semiannual basis; 


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1 (v) assist leaders at the regional level 

2 to form partnerships, including the provi3 sion of technical assistance and capacity 

4 building activities such as the dissemina5 tion of best practices and tools within the 

6 State; 

7 (vi) collect and assess data on and re8 port on the performance benchmarks se9 lected by the State partnership and the 

10 Administration for implementation activi11 ties carried out by regional and State part12 nerships; and 

13 (vii) participate in the Administra14 tion’s evaluation and reporting activities. 

15 (7) PERFORMANCE AND EVALUATION.—Before 

16 the State partnership receives an implementation 

17 grant, it and the Administrator shall jointly deter18 mine the performance benchmarks that shall be es19 tablished for the purposes of the implementation 

20 grant. 

21 (8) MATCH.—Each State partnership receiving 

22 an implementation grant shall provide an amount, in 

23 cash or in kind that is not less than 25 percent of 

24 the amount of the grant, to carry out the activities 

25 supported by the grant. The matching funds may be 


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1 provided from funds available from other Federal, 

2 State, local, or private sources to carry out such ac3 tivities. 

4 (9) REPORTS.— 

5 (A) REPORT TO ADMINISTRATION.—For 

6 each year of the implementation grant, the 

7 State partnership receiving the implementation 

8 grant shall submit a report to the Administra9 tion on the performance of the State of the 

10 grant activities, including a description of the 

11 use of the funds, including matched funds, to 

12 complete activities, and a description of the per13 formance of the State partnership in meeting 

14 the performance benchmarks. 

15 (B) REPORT TO CONGRESS.—The Admin16 istration shall submit a report to Congress ana17 lyzing implementation activities, performance, 

18 and fund utilization of the State grantees, in19 cluding an identification of promising practices 

20 and a profile of the activities of each State 

21 grantee. 

22 (e) AUTHORIZATION FOR APPROPRIATIONS.— 

23 (1) PLANNING GRANTS.—There are authorized 

24 to be appropriated to award planning grants under 

25 subsection (c) $8,000,000 for fiscal year 2010, and 


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1 such sums as may be necessary for each subsequent 

2 fiscal year. 

3 (2) IMPLEMENTATION GRANTS.—There are au4 thorized to be appropriated to award implementation 

5 grants under subsection (d), $150,000,000 for fiscal 

6 year 2010, and such sums as may be necessary for 

7 each subsequent fiscal year. 

8 SEC. 413. HEALTH CARE WORKFORCE PROGRAM ASSESS9 MENT. 

10 (a) IN GENERAL.—Section 761 of the Public Health 

11 Service Act (42 U.S.C. 294m) is amended— 

12 (1) by redesignating subsection (c) as sub13 section (e); 

14 (2) by striking subsection (b) and inserting the 

15 following: 

16 ‘‘(b) NATIONAL CENTER FOR HEALTH CARE WORK17 FORCE ANALYSIS.— 

18 ‘‘(1) ESTABLISHMENT.—The Secretary shall es19 tablish the National Center for Health Workforce 

20 Analysis (referred to in this section as the ‘National 

21 Center’). 

22 ‘‘(2) PURPOSES.—The purposes of the National 

23 Center are to— 

24 ‘‘(A) provide for the development of infor25 mation describing the health care workforce and 


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1 the analysis of health care workforce related 

2 issues; 

3 ‘‘(B) carry out the activities under section 

4 792(a); and 

5 ‘‘(C) collect, analyze, and report data re6 lated to programs under this title in coordina7 tion with the State and Regional Centers for 

8 Health Workforce Analysis described in sub9 section (c) (referred to in this section as the 

10 ‘State and Regional Centers’) and with the 

11 State agency responsible for the statewide em12 ployment statistics system under section 15(e) 

13 of the Wagner-Peyser Act (29 U.S.C. 49l–2). 

14 ‘‘(3) FUNCTIONS.—The National Center shall, 

15 in coordination with the Commission established in 

16 section 411 of the Affordable Health Choices Act— 

17 ‘‘(A) annually evaluate the effectiveness of 

18 programs under this title; 

19 ‘‘(B) develop and publish benchmarks for 

20 performance for programs under this title; 

21 ‘‘(C) establish, maintain, and make pub22 licly available through the Internet a national 

23 health workforce database to collect data 

24 from— 


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1 ‘‘(i) longitudinal evaluations (as de2 scribed in subsection (d)(2) on perform3 ance measures (as developed under sec4 tions 749(d)(3), 757(d)(3), and 762(a)(3)); 

5 and 

6 ‘‘(ii) the State and Regional Centers 

7 described in subsection (c); and 

8 ‘‘(D) and establish and maintain a registry 

9 of each grant awarded under this title. 

10 ‘‘(4) COLLABORATION AND DATA SHARING.— 

11 ‘‘(A) IN GENERAL.—The National Center 

12 shall collaborate with Federal agencies, health 

13 professions education organizations, health pro14 fessions organizations, and professional medical 

15 societies for the purpose of linking data regard16 ing grants awarded under this title with 1 or 

17 more of the following: 

18 ‘‘(i) Data maintained by the Depart19 ment of Health and Human Services and 

20 its various agencies. 

21 ‘‘(ii) Data maintained by the Bureau 

22 of Labor Statistics. 

23 ‘‘(iii) Data maintained by the Census 

24 Bureau. 


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1 ‘‘(iv) Data maintained by the Depart2 ments of Defense and Veterans Affairs. 

3 ‘‘(v) Data sets maintained by health 

4 professions education organizations, health 

5 professions organizations, or professional 

6 medical societies. 

7 ‘‘(vi) Other data sets, as the Secretary 

8 determines appropriate. 

9 ‘‘(B) CONTRACTS FOR HEALTH WORK10 FORCE ANALYSIS.—For the purpose of carrying 

11 out the activities described in subparagraph 

12 (A), the National Center may enter into con13 tracts with health professions education organi14 zations, health professions organizations, or 

15 professional medical societies. 

16 ‘‘(c) STATE AND REGIONAL CENTERS FOR HEALTH

17 WORKFORCE ANALYSIS.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall award 

19 grants to, or enter into contracts with, eligible enti20 ties for purposes of— 

21 ‘‘(A) collecting, analyzing, and reporting to 

22 the National Center data regarding programs 

23 under this title; 


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1 ‘‘(B) conducting and broadly disseminating 

2 research and reports on State, regional, and na3 tional health workforce issues; 

4 ‘‘(C) evaluating the effectiveness of pro5 grams under this title; and 

6 ‘‘(D) providing technical assistance to local 

7 and regional entities on the collection, analysis, 

8 and reporting of data related to health work9 force issues. 

10 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible for a 

11 grant or contract under this subsection, an entity 

12 shall— 

13 ‘‘(A) be a State (including a State Office 

14 of Rural Health), a State workforce investment 

15 board, a public health or health professions 

16 school, an academic health center (including an 

17 area health education center program), or an 

18 appropriate public or private nonprofit entity or 

19 a partnership of such entities, such as a com20 munity college system; and 

21 ‘‘(B) submit to the Secretary an applica22 tion at such time, in such manner, and con23 taining such information as the Secretary may 

24 require. 


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1 ‘‘(d) INCREASE IN GRANTS FOR LONGITUDINAL

2 EVALUATIONS.— 

3 ‘‘(1) IN GENERAL.—The Secretary shall in4 crease the amount of a grant or contract awarded to 

5 an eligible entity under this title for the establish6 ment and maintenance of a longitudinal evaluation 

7 of students, residents, fellows, interns, or faculty 

8 who have received education, training, or financial 

9 assistance from programs under this title. 

10 ‘‘(2) CAPABILITY.—A longitudinal evaluation 

11 shall be capable of— 

12 ‘‘(A) studying participation in the National 

13 Health Service Corps, practice in federally 

14 qualified health centers, practice in health pro15 fessional shortage areas and medically under16 served areas, and practice in primary care; and 

17 ‘‘(B) collecting and reporting data on per18 formance measures developed under sections 

19 749(d)(3), 757(d)(3), and 762(a)(3). 

20 ‘‘(3) GUIDELINES.—A longitudinal evaluation 

21 shall comply with guidelines issued under sections 

22 749(d)(4), 757(d)(4), and 762(a)(4). 

23 ‘‘(4) ELIGIBLE ENTITIES.—To be eligible to ob24 tain an increase under this section, an entity shall 

25 be a recipient of a grant or contract under this title 


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1 and have not previously received an increase under 

2 this section.’’; and 

3 (3) in subsection (e), as so redesignated— 

4 (A) by striking paragraph (1) and insert5 ing the following: 

6 ‘‘(1) IN GENERAL.— 

7 ‘‘(A) NATIONAL CENTER FOR HEALTH

8 WORKFORCE ANALYSIS.—To carry out sub9 section (b), there are authorized to be appro10 priated $5,000,000 for each of fiscal years 

11 2010 and 2011, $10,000,000 for each of fiscal 

12 years 2012 through 2014, and such sums as 

13 may be necessary for each subsequent fiscal 

14 year. 

15 ‘‘(B) STATE AND REGIONAL CENTERS.— 

16 To carry out subsection (c), there are author17 ized to be appropriated $4,500,000 for each of 

18 fiscal years 2010 through 2014, and such sums 

19 as may be necessary for each subsequent fiscal 

20 year. 

21 ‘‘(C) GRANTS FOR LONGITUDINAL EVALUA22 TIONS.—To carry out subsection (d), there are 

23 authorized to be appropriated such sums as 

24 may be necessary for fiscal years 2010 through 

25 2014. 


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1 ‘‘(D) CARRYOVER FUNDS.—An entity that 

2 receives an award under this section may carry 

3 over funds from 1 fiscal year to another without 

4 obtaining approval from the Secretary. In no 

5 case may any funds be carried over pursuant to 

6 the preceding sentence for more than 3 years.’’; 

7 and 

8 (4) in paragraph (2), by striking ‘‘subsection 

9 (a)’’ and inserting ‘‘paragraph (1)’’. 

10 (b) TRANSFER OF FUNCTIONS.—Not later than 180 

11 days after the date of enactment of this Act, all of the 

12 functions, authorities, and resources of the National Cen13 ter for Health Workforce Analysis of the Health Resources 

14 and Services Administration, as in effect on the date be15 fore the date of enactment of this Act, shall be transferred 

16 to the National Center for Health Workforce Analysis es17 tablished under section 761 of the Public Health Service 

18 Act, as amended by subsection (a). 

19 (c) PRIORITY FOR USE OF LONGITUDINAL EVALUA20 TIONS.—Section 791(a)(1) of the Public Health Service 

21 Act (42 U.S.C. 295j(a)(1)) is amended— 

22 (1) in subparagraph (A), by striking ‘‘or’’ at 

23 the end; 

24 (2) in subparagraph (B), by striking the period 

25 and inserting ‘‘; or’’; and 


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1 (3) by adding at the end the following: 

2 ‘‘(C) utilizes a longitudinal evaluation (as 

3 described in section 761(d)(2)) and reports data 

4 from such system to the national workforce 

5 database (as established under section 

6 761(b)(3)(D)).’’. 

7 (d) PERFORMANCE MEASURES; GUIDELINES FOR

8 LONGITUDINAL EVALUATIONS.— 

9 (1) ADVISORY COMMITTEE ON TRAINING IN PRI10 MARY CARE MEDICINE AND DENTISTRY.—Section 

11 748(d) of the Public Health Service Act is amend12 ed— 

13 (A) in paragraph (1), by striking ‘‘and’’ at 

14 the end; 

15 (B) in paragraph (2), by striking the pe16 riod and inserting a semicolon; and 

17 (C) by adding at the end the following: 

18 ‘‘(3) not later than 3 years after the date of en19 actment of the Affordable Health Choices Act, de20 velop, publish, and implement performance meas21 ures, which shall be quantitative to the extent pos22 sible, for programs under this part; 

23 ‘‘(4) develop and publish guidelines for longitu24 dinal evaluations (as described in section 761(d)(2)) 

25 for programs under this part; and 


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1 ‘‘(5) recommend appropriation levels for pro2 grams under this part.’’. 

3 (2) ADVISORY COMMITTEE ON INTERDISCIPLI4 NARY, COMMUNITY-BASED LINKAGES.—Section 

5 756(d) of the Public Health Service Act is amend6 ed— 

7 (A) in paragraph (1), by striking ‘‘and’’ at 

8 the end; 

9 (B) in paragraph (2), by striking the pe10 riod and inserting a semicolon; and 

11 (C) by adding at the end the following: 

12 ‘‘(3) not later than 3 years after the date of en13 actment of the Affordable Health Choices Act, de14 velop, publish, and implement performance meas15 ures, which shall be quantitative to the extent pos16 sible, for programs under this part; 

17 ‘‘(4) develop and publish guidelines for longitu18 dinal evaluations (as described in section 761(d)(2)) 

19 for programs under this part; and 

20 ‘‘(5) recommend appropriation levels for pro21 grams under this part.’’. 

22 (3) ADVISORY COUNCIL ON GRADUATE MEDICAL

23 EDUCATION.—Section 762(a) of the Public Health 

24 Service Act (42 U.S.C. 294o(a)) is amended— 


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1 (A) in paragraph (1), by striking ‘‘and’’ at 

2 the end; 

3 (B) in paragraph (2), by striking the pe4 riod and inserting a semicolon; and 

5 (C) by adding at the end the following: 

6 ‘‘(3) not later than 3 years after the date of en7 actment of the Affordable Health Choices Act de8 velop, publish, and implement performance meas9 ures, which shall be quantitative to the extent pos10 sible, for programs under this title, except for pro11 grams under part C or D; 

12 ‘‘(4) develop and publish guidelines for longitu13 dinal evaluations (as described in section 761(d)(2)) 

14 for programs under this title, except for programs 

15 under part C or D; and 

16 ‘‘(5) recommend appropriation levels for pro17 grams under this title, except for programs under 

18 part C or D.’’. 

19 Subtitle C—Increasing the Supply 

20 of the Health Care Workforce 

21 SEC. 421. FEDERALLY SUPPORTED STUDENT LOAN FUNDS. 

22 (a) MEDICAL SCHOOLS AND PRIMARY HEALTH

23 CARE.—Section 723 of the Public Health Service Act (42 

24 U.S.C. 292s) is amended— 

25 (1) in subsection (a)— 


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1 (A) in paragraph (1), by striking subpara2 graph (B) and inserting the following: 

3 ‘‘(B) to practice in such care for 10 years 

4 (including residency training in primary health 

5 care) or through the date on which the loan is 

6 repaid in full, whichever occurs first.’’; and 

7 (B) by striking paragraph (3) and insert8 ing the following: 

9 ‘‘(3) NONCOMPLIANCE BY STUDENT.—Each 

10 agreement entered into with a student pursuant to 

11 paragraph (1) shall provide that, if the student fails 

12 to comply with such agreement, the loan involved 

13 will begin to accrue interest at a rate of 2 percent 

14 per year greater than the rate at which the student 

15 would pay if compliant in such year.’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(d) SENSE OF CONGRESS.—It is the sense of Con18 gress that funds repaid under the loan program under this 

19 section should not be transferred to the Treasury of the 

20 United States or otherwise used for any other purpose 

21 other than to carry out this section.’’. 

22 (b) STUDENT LOAN GUIDELINES.—The Secretary of 

23 Health and Human Services shall not require parental fi24 nancial information for an independent student to deter25 mine financial need under section 723 of the Public 


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1 Health Service Act (42 U.S.C. 292s) and the determina2 tion of need for such information shall be at the discretion 

3 of applicable school loan officer. The Secretary shall 

4 amend guidelines issued by the Health Resources and 

5 Services Administration in accordance with the preceding 

6 sentence. 

7 SEC. 422. NURSING STUDENT LOAN PROGRAM. 

8 (a) LOAN AGREEMENTS.—Section 836(a) of the Pub9 lic Health Service Act (42 U.S.C. 297b(a)) is amended— 

10 (1) by striking ‘‘$2,500’’ and inserting 

11 ‘‘$3,300’’; 

12 (2) by striking ‘‘$4,000’’ and inserting 

13 ‘‘$5,200’’; and 

14 (3) by striking ‘‘$13,000’’ and all that follows 

15 through the period and inserting ‘‘$17,000 in the 

16 case of any student during fiscal years 2010 and 

17 2011. After fiscal year 2011, such amounts shall be 

18 adjusted to provide for a cost-of-attendance increase 

19 for the yearly loan rate and the aggregate of the 

20 loans.’’. 

21 (b) LOAN PROVISIONS.—Section 836(b) of the Public 

22 Health Service Act (42 U.S.C. 297b(b)) is amended— 

23 (1) in paragraph (1)(C), by striking ‘‘1986’’ 

24 and inserting ‘‘2000’’; and 


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1 (2) in paragraph (3), by striking ‘‘the date of 

2 enactment of the Nurse Training Amendments of 

3 1979’’ and inserting ‘‘September 29, 1995’’. 

4 SEC. 423. HEALTH CARE WORKFORCE LOAN REPAYMENT 

5 PROGRAMS. 

6 Part E of title VII of the Public Health Service Act 

7 (42 U.S.C. 294n et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘Subpart 3—Recruitment and Retention Programs 

10 ‘‘SEC. 775. INVESTMENT IN TOMORROW’S PEDIATRIC 

11 HEALTH CARE WORKFORCE. 

12 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab13 lish and carry out a pediatric specialty loan repayment 

14 program under which the eligible individual agrees to be 

15 employed full-time for a specified period (which shall not 

16 be less than 2 years) in providing pediatric medical sub17 specialty, pediatric surgical specialty, or child and adoles18 cent mental and behavioral health care, including sub19 stance abuse prevention and treatment services. 

20 ‘‘(b) PROGRAM ADMINISTRATION.—Through the pro21 gram established under this section, the Secretary shall 

22 enter into contracts with qualified health professionals 

23 under which— 

24 ‘‘(1) such qualified health professionals will 

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1 atric surgical specialty, or child and adolescent men2 tal and behavioral health care in an area with a 

3 shortage of the specified pediatric subspecialty that 

4 has a sufficient pediatric population to support such 

5 pediatric subspecialty, as determined by the Sec6 retary; and 

7 ‘‘(2) the Secretary agrees to make payments on 

8 the principal and interest of undergraduate, grad9 uate, or graduate medical education loans of profes10 sionals described in paragraph (1) of not more than 

11 $35,000 a year for each year of agreed upon service 

12 under such paragraph for a period of not more than 

13 3 years during the qualified health professional’s— 

14 ‘‘(A) participation in an accredited pedi15 atric medical subspecialty, pediatric surgical 

16 specialty, or child and adolescent mental health 

17 subspecialty residency or fellowship; or 

18 ‘‘(B) employment as a pediatric medical 

19 subspecialist, pediatric surgical specialist, or 

20 child and adolescent mental health professional 

21 serving an area or population described in such 

22 paragraph. 

23 ‘‘(c) IN GENERAL.— 

24 ‘‘(1) ELIGIBLE INDIVIDUALS.— 


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1 ‘‘(A) PEDIATRIC MEDICAL SPECIALISTS

2 AND PEDIATRIC SURGICAL SPECIALISTS.—For 

3 purposes of contracts with respect to pediatric 

4 medical specialists and pediatric surgical spe5 cialists, the term ‘qualified health professional’ 

6 means a licensed physician who— 

7 ‘‘(i) is entering or receiving training 

8 in an accredited pediatric medical sub9 specialty or pediatric surgical specialty 

10 residency or fellowship; or 

11 ‘‘(ii) has completed (but not prior to 

12 the end of the calendar year in which this 

13 section is enacted) the training described 

14 in subparagraph (B). 

15 ‘‘(B) CHILD AND ADOLESCENT MENTAL

16 AND BEHAVIORAL HEALTH.—For purposes of 

17 contracts with respect to child and adolescent 

18 mental and behavioral health care, the term 

19 ‘qualified health professional’ means a health 

20 care professional who— 

21 ‘‘(i) has received specialized training 

22 or clinical experience in child and adoles23 cent mental health in psychiatry, psy24 chology, school psychology, behavioral pedi25 atrics, psychiatric nursing, social work, 


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1 school social work, substance abuse dis2 order prevention and treatment, marriage 

3 and family therapy, school counseling, or 

4 professional counseling; 

5 ‘‘(ii) has a license or certification in a 

6 State to practice allopathic medicine, os7 teopathic medicine, psychology, school psy8 chology, psychiatric nursing, social work, 

9 school social work, marriage and family 

10 therapy, school counseling, or professional 

11 counseling; or 

12 ‘‘(iii) is a mental health service pro13 fessional who completed (but not before 

14 the end of the calendar year in which this 

15 section is enacted) specialized training or 

16 clinical experience in child and adolescent 

17 mental health described in clause (i). 

18 ‘‘(2) ADDITIONAL ELIGIBILITY REQUIRE19 MENTS.—The Secretary may not enter into a con20 tract under this subsection with an eligible indi21 vidual unless— 

22 ‘‘(A) the individual agrees to work in, or 

23 for a provider serving, a health professional 

24 shortage area or medically underserved area, or 

25 to serve a medically underserved population; 


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1 ‘‘(B) the individual is a United States cit2 izen or a permanent legal United States resi3 dent; and 

4 ‘‘(C) if the individual is enrolled in a grad5 uate program, the program is accredited, and 

6 the individual has an acceptable level of aca7 demic standing (as determined by the Sec8 retary). 

9 ‘‘(d) PRIORITY.—In entering into contracts under 

10 this subsection, the Secretary shall give priority to appli11 cants who— 

12 ‘‘(1) are or will be working in a school or other 

13 pre-kindergarten, elementary, or secondary edu14 cation setting; 

15 ‘‘(2) have familiarity with evidence-based meth16 ods and cultural and linguistic competence health 

17 care services; and 

18 ‘‘(3) demonstrate financial need. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

20 is authorized to be appropriated $30,000,000 for each of 

21 fiscal years 2010 through 2014 to carry out subsection 

22 (c)(1)(A) and $20,000,000 for each of fiscal years 2010 

23 through 2013 to carry out subsection (c)(1)(B).’’. 


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1 SEC. 424. PUBLIC HEALTH WORKFORCE RECRUITMENT 

2 AND RETENTION PROGRAMS. 

3 Part E of title VII of the Public Health Service Act 

4 (42 U.S.C. 294n et seq.), as amended by section 423, is 

5 further amended by adding at the end the following: 

6 ‘‘SEC. 776. PUBLIC HEALTH WORKFORCE LOAN REPAYMENT 

7 PROGRAM. 

8 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab9 lish the Public Health Workforce Loan Repayment Pro10 gram (referred to in this section as the ‘Program’) to as11 sure an adequate supply of public health professionals to 

12 eliminate critical public health workforce shortages in 

13 Federal, State, local, and tribal public health agencies. 

14 ‘‘(b) ELIGIBILITY.—To be eligible to participate in 

15 the Program, an individual shall— 

16 ‘‘(1)(A) be accepted for enrollment, or be en17 rolled, as a student in an accredited academic edu18 cational institution in a State or territory in the 

19 final year of a course of study or program leading 

20 to a public health or health professions degree or 

21 certificate; and have accepted employment with a 

22 Federal, State, local, or tribal public health agency, 

23 or a related training fellowship, as recognized by the 

24 Secretary, to commence upon graduation; 

25 ‘‘(B)(i) have graduated, during the preceding 

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1 tution in a State or territory and received a public 

2 health or health professions degree or certificate; 

3 and 

4 ‘‘(ii) be employed by, or have accepted employ5 ment with, a Federal, State, local, or tribal public 

6 health agency or a related training fellowship, as 

7 recognized by the Secretary; 

8 ‘‘(2) be a United States citizen; and 

9 ‘‘(3)(A) submit an application to the Secretary 

10 to participate in the Program; 

11 ‘‘(B) execute a written contract as required in 

12 subsection (c); and 

13 ‘‘(4) not have received, for the same service, a 

14 reduction of loan obligations under section 455(m), 

15 428J, 428K, 428L, or 460 of the Higher Education 

16 Act of 1965. 

17 ‘‘(c) CONTRACT.—The written contract (referred to 

18 in this section as the ‘written contract’) between the Sec19 retary and an individual shall contain— 

20 ‘‘(1) an agreement on the part of the Secretary 

21 that the Secretary will repay on behalf of the indi22 vidual loans incurred by the individual in the pursuit 

23 of the relevant degree or certificate in accordance 

24 with the terms of the contract; 


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1 ‘‘(2) an agreement on the part of the individual 

2 that the individual will serve in the full-time employ3 ment of a Federal, State, local, or tribal public 

4 health agency or a related fellowship program in a 

5 position related to the course of study or program 

6 for which the contract was awarded for a period of 

7 time (referred to in this section as the ‘period of ob8 ligated service’) equal to the greater of— 

9 ‘‘(A) 3 years; or 

10 ‘‘(B) such longer period of time as deter11 mined appropriate by the Secretary and the in12 dividual; 

13 ‘‘(3) an agreement, as appropriate, on the part 

14 of the individual to relocate to a priority service area 

15 (as determined by the Secretary) in exchange for an 

16 additional loan repayment incentive amount to be 

17 determined by the Secretary; 

18 ‘‘(4) a provision that any financial obligation of 

19 the United States arising out of a contract entered 

20 into under this section and any obligation of the in21 dividual that is conditioned thereon, is contingent on 

22 funds being appropriated for loan repayments under 

23 this section; 


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1 ‘‘(5) a statement of the damages to which the 

2 United States is entitled, under this section for the 

3 individual’s breach of the contract; and 

4 ‘‘(6) such other statements of the rights and li5 abilities of the Secretary and of the individual, not 

6 inconsistent with this section. 

7 ‘‘(d) PAYMENTS.— 

8 ‘‘(1) IN GENERAL.—A loan repayment provided 

9 for an individual under a written contract under the 

10 Program shall consist of payment, in accordance 

11 with paragraph (2), on behalf of the individual of 

12 the principal, interest, and related expenses on gov13 ernment and commercial loans received by the indi14 vidual regarding the undergraduate or graduate edu15 cation of the individual (or both), which loans were 

16 made for tuition expenses incurred by the individual. 

17 ‘‘(2) PAYMENTS FOR YEARS SERVED.—For 

18 each year of obligated service that an individual con19 tracts to serve under subsection (c) the Secretary 

20 may pay up to $35,000 on behalf of the individual 

21 for loans described in paragraph (1). With respect to 

22 participants under the Program whose total eligible 

23 loans are less than $105,000, the Secretary shall 

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1 ble loan balance for each year of obligated service of 

2 the individual. 

3 ‘‘(3) TAX LIABILITY.—For the purpose of pro4 viding reimbursements for tax liability resulting 

5 from payments under paragraph (2) on behalf of an 

6 individual, the Secretary shall, in addition to such 

7 payments, make payments to the individual in an 

8 amount not to exceed 39 percent of the total amount 

9 of loan repayments made for the taxable year in10 volved. 

11 ‘‘(e) POSTPONING OBLIGATED SERVICE.—With re12 spect to an individual receiving a degree or certificate from 

13 a health professions or other related school, the date of 

14 the initiation of the period of obligated service may be 

15 postponed as approved by the Secretary. 

16 ‘‘(f) BREACH OF CONTRACT.—An individual who fails 

17 to comply with the contract entered into under subsection 

18 (c) shall be subject to the same financial penalties as pro19 vided for under section 338E for breaches of loan repay20 ment contracts under section 338B. 

21 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

22 is authorized to be appropriated to carry out this section 

23 $195,000,000 for fiscal year 2010, and such sums as may 

24 be necessary for each of fiscal years 2011 through 2015.’’. 


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1 SEC. 425. ALLIED HEALTH WORKFORCE RECRUITMENT 

2 AND RETENTION PROGRAMS. 

3 (a) PURPOSE.—The purpose of this section is to as4 sure an adequate supply of allied health professionals to 

5 eliminate critical allied health workforce shortages in Fed6 eral, State, local, and tribal public health agencies or in 

7 settings where patients might require health care services, 

8 including acute care facilities, ambulatory care facilities, 

9 personal residences and other settings, as recognized by 

10 the Secretary of Health and Human Services by author11 izing an Allied Health Loan Forgiveness Program. 

12 (b) ALLIED HEALTH WORKFORCE RECRUITMENT

13 AND RETENTION PROGRAM.—Section 428K of the Higher 

14 Education Act of 1965 (20 U.S.C. 1078–11) is amend15 ed— 

16 (1) in subsection (b), by adding at the end the 

17 following: 

18 ‘‘(18) ALLIED HEALTH PROFESSIONALS.—The 

19 individual is employed full-time as an allied health 

20 professional— 

21 ‘‘(A) in a Federal, State, local, or tribal 

22 public health agency; or 

23 ‘‘(B) in a setting where patients might re24 quire health care services, including acute care 

25 facilities, ambulatory care facilities, personal 

26 residences and other settings located in health 


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1 professional shortage areas, medically under2 served areas, or medically underserved popu3 lations, as recognized by the Secretary of 

4 Health and Human Services.’’; and 

5 (2) in subsection (g)— 

6 (A) by redesignating paragraphs (1) 

7 through (9) as paragraphs (2) through (10), re8 spectively; and 

9 (B) by inserting before paragraph (2) (as 

10 redesignated by subparagraph (A)) the fol11 lowing: 

12 ‘‘(1) ALLIED HEALTH PROFESSIONAL.—The 

13 term ‘allied health professional’ means an allied 

14 health professional as defined in section 799B(5) of 

15 the Public Heath Service Act (42 U.S.C. 295p(5)) 

16 who— 

17 ‘‘(A) has graduated and received an allied 

18 health professions degree or certificate from an 

19 institution of higher education; and 

20 ‘‘(B) is employed with a Federal, State, 

21 local or tribal public health agency, or in a set22 ting where patients might require health care 

23 services, including acute care facilities, ambula24 tory care facilities, personal residences and 

25 other settings located in health professional 


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1 shortage areas, medically underserved areas, or 

2 medically underserved populations, as recog3 nized by the Secretary of Health and Human 

4 Services.’’. 

5 SEC. 426. GRANTS FOR STATE AND LOCAL PROGRAMS. 

6 (a) IN GENERAL.—Section 765(d) of the Public 

7 Health Service Act (42 U.S.C. 295(d)) is amended— 

8 (1) in paragraph (7), by striking ‘‘; or’’ and in9 serting a semicolon; 

10 (2) by redesignating paragraph (8) as para11 graph (9); and 

12 (3) by inserting after paragraph (7) the fol13 lowing: 

14 ‘‘(8) public health workforce loan repayment 

15 programs; or’’. 

16 (b) TRAINING FOR MID-CAREER PUBLIC HEALTH

17 PROFESSIONALS.—Part E of title VII of the Public 

18 Health Service Act (42 U.S.C. 294n et seq.), as amended 

19 by section 424, is further amended by adding at the end 

20 the following: 

21 ‘‘SEC. 777. TRAINING FOR MID-CAREER PUBLIC AND ALLIED 

22 HEALTH PROFESSIONALS. 

23 ‘‘(a) IN GENERAL.—The Secretary may make grants 

24 to, or enter into contracts with, any eligible entity to 

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1 gree or professional training programs for the purpose of 

2 enabling mid-career professionals in the public health and 

3 allied health workforce to receive additional training in the 

4 field of public health and allied health. 

5 ‘‘(b) ELIGIBILITY.— 

6 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en7 tity’ indicates an accredited educational institution 

8 that offers a course of study, certificate program, or 

9 professional training program in public or allied 

10 health or a related discipline, as determined by the 

11 Secretary 

12 ‘‘(2) ELIGIBLE INDIVIDUALS.—The term ‘eligi13 ble individuals’ includes those individuals employed 

14 in public and allied health positions at the Federal, 

15 State, tribal, or local level who are interested in re16 taining or upgrading their education. 

17 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

18 is authorized to be appropriated to carry out this section, 

19 $60,000,000 for fiscal year 2010 and such sums as may 

20 be necessary for each of fiscal years 2011 through 2015. 

21 Fifty percent of appropriated funds shall be allotted to 

22 public health mid-career professionals and 50 percent shall 

23 be allotted to allied health mid-career professionals.’’. 


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1 SEC. 427. FUNDING FOR NATIONAL HEALTH SERVICE 

2 CORPS. 

3 Section 338H(a) of the Public Health Service Act (42 

4 U.S.C. 254q(a)) is amended to read as follows: 

5 ‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—For the 

6 purpose of carrying out this section, there is authorized 

7 to be appropriated, out of any funds in the Treasury not 

8 otherwise appropriated, the following: 

9 ‘‘(1) For fiscal year 2010, $320,461,632. 

10 ‘‘(2) For fiscal year 2011, $414,095,394. 

11 ‘‘(3) For fiscal year 2012, $535,087,442. 

12 ‘‘(4) For fiscal year 2013, $691,431,432. 

13 ‘‘(5) For fiscal year 2014, $893,456,433. 

14 ‘‘(6) For fiscal year 2015, $1,154,510,336. 

15 ‘‘(7) For fiscal year 2016, and each subsequent 

16 fiscal year, the amount appropriated for the pre17 ceding fiscal year adjusted by the product of— 

18 ‘‘(A) one plus the average percentage in19 crease in the costs of health professions edu20 cation during the prior fiscal year; and 

21 ‘‘(B) one plus the average percentage 

22 change in the number of individuals residing in 

23 health professions shortage areas designated 

24 under section 333 during the prior fiscal year, 

25 relative to the number of individuals residing in 

26 such areas during the previous fiscal year.’’. 


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1 øNOTE: this section is the same as section 173 

2 of title I.¿ 

3 SEC. 428. NURSE-MANAGED HEALTH CLINICS. 

4 (a) PURPOSE.—The purpose of this section is to fund 

5 the development and operation of nurse-managed health 

6 clinics in order to provide comprehensive primary health 

7 care and wellness services to vulnerable populations living 

8 in the Nation’s medically underserved communities, and 

9 to reduce the level of health disparities experienced by vul10 nerable populations. 

11 (b) GRANTS.—Subpart 1 of part D of title III of the 

12 Public Health Service Act (42 U.S.C. 254b et seq.) is 

13 amended by inserting after section 330A the following: 

14 ‘‘SEC. 330A–1. GRANTS TO NURSE–MANAGED HEALTH CLIN15 ICS. 

16 ‘‘(a) DEFINITIONS.— 

17 ‘‘(1) COMPREHENSIVE PRIMARY HEALTH CARE

18 SERVICES.—In this section, the term ‘comprehensive 

19 primary health care services’ means the primary 

20 health services described in section 330(b)(1). 

21 ‘‘(2) NURSE-MANAGED HEALTH CLINIC.—The 

22 term ‘nurse-managed health clinic’ means a nurse23 practice arrangement, managed by advanced practice 

24 nurses, that provides primary care or wellness serv25 ices to underserved or vulnerable populations and 


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1 that is associated with a school, college, university or 

2 department of nursing, federally qualified health 

3 center, or independent nonprofit health or social 

4 services agency. 

5 ‘‘(b) AUTHORITY TO AWARD GRANTS.—The Sec6 retary shall award grants for the cost of the operation of 

7 nurse-managed health clinics that meet the requirements 

8 of this section. 

9 ‘‘(c) APPLICATIONS.—To be eligible to receive a grant 

10 under this section, an entity shall— 

11 ‘‘(1) be an NMHC; and 

12 ‘‘(2) submit to the Secretary an application at 

13 such time, in such manner, and containing— 

14 ‘‘(A) assurances that nurses are the major 

15 providers of services at the NMHC and that at 

16 least 1 advanced practice nurse holds an execu17 tive management position within the organiza18 tional structure of the NMHC; 

19 ‘‘(B) an assurance that the NMHC will 

20 continue providing comprehensive primary 

21 health care services or wellness services without 

22 regard to income or insurance status of the pa23 tient for the duration of the grant period; and 

24 ‘‘(C) an assurance that, not later than 90 

25 days of receiving a grant under this section, the 


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1 NMHC will establish a community advisory 

2 committee, for which a majority of the members 

3 shall be individuals who are served by the 

4 NMHC. 

5 ‘‘(d) GRANT AMOUNT.—The amount of any grant 

6 made under this section for any fiscal year shall be deter7 mined by the Secretary, taking into account— 

8 ‘‘(1) the financial need of the NMHC, consid9 ering State, local, and other operational funding pro10 vided to the NMHC; and 

11 ‘‘(2) other factors, as the Secretary determines 

12 appropriate. 

13 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purposes of carrying out this section, there are authorized 

15 to be appropriated $50,000,000 for the fiscal year 2010 

16 and such sums as may be necessary for each of the fiscal 

17 years 2011 through 2014.’’. 

18 SEC. 429. ELIMINATION OF CAP ON COMMISSIONED CORPS. 

19 Section 202 of the Department of Health and Human 

20 Services Appropriations Act, 1993 (Public Law 102-394) 

21 is amended by striking ‘‘not to exceed 2,800’’. 

22 SEC. 430. ESTABLISHING A READY RESERVE CORPS. 

23 Section 203 of the Public Health Service Act (42 

24 U.S.C. 204) is amended to read as follows: 


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1 ‘‘SEC. 203. COMMISSIONED CORPS AND READY RESERVE 

2 CORPS. 

3 ‘‘(a) ESTABLISHMENT.— 

4 ‘‘(1) IN GENERAL.—There shall be in the Serv5 ice a commissioned Regular Corps and a Ready Re6 serve Corps for service in time of national emer7 gency. 

8 ‘‘(2) REQUIREMENT.—All commissioned officers 

9 shall be citizens of the United States and shall be 

10 appointed without regard to the civil-service laws 

11 and compensated without regard to the Classifica12 tion Act of 1923, as amended. 

13 ‘‘(3) APPOINTMENT.—Commissioned officers of 

14 the Ready Reserve Corps shall be appointed by the 

15 President and commissioned officers of the Regular 

16 Corps shall be appointed by the President with the 

17 advice and consent of the Senate. 

18 ‘‘(4) ACTIVE DUTY.—Commissioned officers of 

19 the Ready Reserve Corps shall at all times be sub20 ject to call to active duty by the Surgeon General, 

21 including active duty for the purpose of training. 

22 ‘‘(5) WARRANT OFFICERS.—Warrant officers 

23 may be appointed to the Service for the purpose of 

24 providing support to the health and delivery systems 

25 maintained by the Service and any warrant officer 

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1 poses of this Act and title 37, United States Code, 

2 to be a commissioned officer within the Commis3 sioned Corps of the Service. 

4 ‘‘(b) ASSIMILATING RESERVE CORP OFFICERS INTO

5 THE REGULAR CORPS.—Effective on the date of enact6 ment of the Affordable Health Choices Act, all individuals 

7 classified as officers in the Reserve Corps under this sec8 tion (as such section existed on the day before the date 

9 of enactment of such Act) and serving on active duty shall 

10 be deemed to be commissioned officers of the Regular 

11 Corps. 

12 ‘‘(c) PURPOSE AND USE OF READY RESEARCH.— 

13 ‘‘(1) PURPOSE.—The purpose of the Ready Re14 serve Corps is to fulfill the need to have additional 

15 Commissioned Corps personnel available on short 

16 notice (similar to the uniformed service’s reserve 

17 program) to assist regular Commissioned Corps per18 sonnel to meet both routine public health and emer19 gency response missions. 

20 ‘‘(2) USES.—The Ready Reserve Corps shall— 

21 ‘‘(A) participate in routine training to 

22 meet the general and specific needs of the Com23 missioned Corps; 

24 ‘‘(B) be available and ready for involuntary 

25 calls to active duty during national emergencies 


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1 and public health crises, similar to the uni2 formed service reserve personnel; 

3 ‘‘(C) be available for backfilling critical po4 sitions left vacant during deployment of active 

5 duty Commissioned Corps members, as well as 

6 for deployment to respond to public health 

7 emergencies, both foreign and domestic; and 

8 ‘‘(D) be available for service assignment in 

9 isolated, hardship, and medically underserved 

10 communities (as defined in section 799B) to 

11 improve access to health services. 

12 ‘‘(d) FUNDING.—For the purpose of carrying out the 

13 duties and responsibilities of the Commissioned Corps 

14 under this section, there are authorized to be appropriated 

15 $5,000,000 for each of fiscal years 2010 through 2014 

16 for recruitment and training and $12,500,000 for each of 

17 fiscal years 2010 through 2014 for the Ready Reserve 

18 Corps.’’. 

19 Subtitle D—Enhancing Health Care 

20 Workforce Education and Training 

21 SEC. 431. TRAINING IN FAMILY MEDICINE, GENERAL INTER22 NAL MEDICINE, GENERAL PEDIATRICS, AND 

23 PHYSICIAN ASSISTANTSHIP. 

24 Part C of title VII (42 U.S.C. 293k et seq.) is amend25 ed by striking section 747 and inserting the following: 


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1 ‘‘SEC. 747. PRIMARY CARE TRAINING AND ENHANCEMENT. 

2 ‘‘(a) SUPPORT AND DEVELOPMENT OF PRIMARY

3 CARE TRAINING PROGRAMS.— 

4 ‘‘(1) IN GENERAL.—The Secretary may make 

5 grants to, or enter into contracts with, an accredited 

6 public or nonprofit private hospital, school of medi7 cine or osteopathic medicine, academically affiliated 

8 physician assistant training program, or a public or 

9 private nonprofit entity which the Secretary has de10 termined is capable of carrying out such grant or 

11 contract— 

12 ‘‘(A) to plan, develop, operate, or partici13 pate in an accredited professional training pro14 gram, including an accredited residency or in15 ternship program in the field of family medi16 cine, general internal medicine, or general pedi17 atrics for medical students, interns, residents, 

18 or practicing physicians as defined by the Sec19 retary; 

20 ‘‘(B) to provide need-based financial assist21 ance in the form of traineeships and fellowships 

22 to medical students, interns, residents, prac23 ticing physicians, or other medical personnel, 

24 who are participants in any such program, and 

25 who plan to specialize or work in the practice 

26 of the fields defined in subparagraph (A); 


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1 ‘‘(C) to plan, develop, and operate a pro2 gram for the training of physicians who plan to 

3 teach in family medicine, general internal medi4 cine, or general pediatrics training programs; 

5 ‘‘(D) to plan, develop, and operate a pro6 gram for the training of physicians teaching in 

7 community-based settings; 

8 ‘‘(E) to provide financial assistance in the 

9 form of traineeships and fellowships to physi10 cians who are participants in any such pro11 grams and who plan to teach or conduct re12 search in a family medicine, general internal 

13 medicine, or general pediatrics training pro14 gram; 

15 ‘‘(F) to plan, develop, and operate a physi16 cian assistant education program, and for the 

17 training of individuals who will teach in pro18 grams to provide such training; 

19 ‘‘(G) to plan, develop, and operate a dem20 onstration program that provides training in 

21 new competencies, as recommended by the Ad22 visory Committee on Training in Primary Care 

23 Medicine and Dentistry and the National 

24 Health Care Workforce Commission established 


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1 in section 411 of the Affordable Health Choices 

2 Act, which may include— 

3 ‘‘(i) providing training to primary 

4 care physicians relevant to providing care 

5 through patient-centered medical homes 

6 (as defined by the Secretary for purposes 

7 of this section); 

8 ‘‘(ii) developing tools and curricula 

9 relevant to patient-centered medical homes; 

10 and 

11 ‘‘(iii) providing continuing education 

12 to primary care physicians relevant to pa13 tient-centered medical homes; and 

14 ‘‘(H) to plan, develop, and operate joint 

15 degree programs to provide interdisciplinary 

16 and interprofessional graduate training in pub17 lic health and other health professions to pro18 vide training in environmental health, infectious 

19 disease control, disease prevention and health 

20 promotion, epidemiological studies and injury 

21 control. 

22 ‘‘(2) DURATION OF AWARDS.—The period dur23 ing which payments are made to an entity from an 

24 award of a grant or contract under this subsection 

25 shall be 5 years. 


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1 ‘‘(b) CAPACITY BUILDING IN PRIMARY CARE.— 

2 ‘‘(1) IN GENERAL.—The Secretary may make 

3 grants to or enter into contracts with accredited 

4 schools of medicine or osteopathic medicine to estab5 lish, maintain, or improve— 

6 ‘‘(A) academic units (which may be depart7 ments, divisions, or other units) or programs 

8 that improve clinical teaching and research in 

9 fields defined in subsection (a)(1)(A); or 

10 ‘‘(B) programs that integrate academic ad11 ministrative units in fields defined in subsection 

12 (a)(1)(A) to enhance interdisciplinary recruit13 ment, training, and faculty development. 

14 ‘‘(2) PREFERENCE IN MAKING AWARDS UNDER

15 THIS SUBSECTION.—In making awards of grants 

16 and contracts under paragraph (1), the Secretary 

17 shall give preference to any qualified applicant for 

18 such an award that agrees to expend the award for 

19 the purpose of— 

20 ‘‘(A) establishing academic units or pro21 grams in fields defined in subsection (a)(1)(A); 

22 or 

23 ‘‘(B) substantially expanding such units or 

24 programs. 


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1 ‘‘(3) PRIORITIES IN MAKING AWARDS.—In 

2 awarding grants or contracts under paragraph (1), 

3 the Secretary shall give priority to qualified appli4 cants that— 

5 ‘‘(A) proposes a collaborative project be6 tween academic administrative units of primary 

7 care; 

8 ‘‘(B) proposes innovative approaches to 

9 clinical teaching using models of primary care, 

10 such as the patient centered medical home, 

11 team management of chronic disease, and inter12 professional integrated models of health care 

13 that incorporate transitions in health care set14 tings and integration physical and mental 

15 health provision; 

16 ‘‘(C) have a record of training the greatest 

17 percentage of providers, or that have dem18 onstrated significant improvements in the per19 centage of providers trained, who enter and re20 main in primary care practice; 

21 ‘‘(D) have a record of training individuals 

22 who are from underrepresented minority groups 

23 or from a rural or disadvantaged background; 

24 ‘‘(E) provide training in the care of vulner25 able populations such as children, older adults, 


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1 homeless individuals, victims of abuse or trau2 ma, individuals with mental health or sub3 stance-related disorders, individuals with HIV/ 

4 AIDS, and individuals with disabilities; 

5 ‘‘(F) establish formal relationships and 

6 submit joint applications with federally qualified 

7 health centers, rural health clinics, area health 

8 education centers, or clinics located in under9 served areas or that serve underserved popu10 lations; 

11 ‘‘(G) teach trainees the skills to provide 

12 interprofessional, integrated care through col13 laboration among health professionals; 

14 ‘‘(H) provide training in enhanced commu15 nication with patients, evidence-based practice, 

16 chronic disease management, preventive care, 

17 health information technology, or other com18 petencies as recommended by the Advisory 

19 Committee on Training in Primary Care Medi20 cine and Dentistry and the National Health 

21 Care Workforce Commission established in sec22 tion 411 of the Affordable Health Choices Act; 

23 or 

24 ‘‘(I) provide training in cultural com25 petency and health literacy. 


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1 ‘‘(4) DURATION OF AWARDS.—The period dur2 ing which payments are made to an entity from an 

3 award of a grant or contract under this subsection 

4 shall be 5 years. 

5 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.— 

6 ‘‘(1) IN GENERAL.—For purposes of carrying 

7 out this section (other than subsection (b)(1)(B)), 

8 there are authorized to be appropriated 

9 $125,000,000 for fiscal year 2010, and such sums 

10 as may be necessary for each of fiscal years 2011 

11 through 2014. 

12 ‘‘(2) TRAINING PROGRAMS.—Fifteen percent of 

13 the amount appropriated pursuant to paragraph (1) 

14 in each such fiscal year shall be allocated to the phy15 sician assistant training programs described in sub16 section (a)(1)(F), which prepare students for prac17 tice in primary care. 

18 ‘‘(3) INTEGRATING ACADEMIC ADMINISTRATIVE

19 UNITS.—For purposes of carrying out subsection 

20 (b)(1)(B), there are authorized to be appropriated 

21 $750,000 for each of fiscal years 2010 through 

22 2014.’’. 


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1 SEC. 432. TRAINING OPPORTUNITIES FOR DIRECT CARE 

2 WORKERS. 

3 Part C of title VII of the Public Health Service Act 

4 (42 U.S.C. 293k et seq.) is amended by inserting after 

5 section 747, as amended by section 431, the following: 

6 ‘‘SEC. 747A. TRAINING OPPORTUNITIES FOR DIRECT CARE 

7 WORKERS. 

8 ‘‘(a) IN GENERAL.—The Secretary shall award 

9 grants to eligible entities to enable such entities to provide 

10 new training opportunities for direct care workers who are 

11 employed in long-term care settings such as nursing 

12 homes (as defined in section 1908(e)(1) of the Social Se13 curity Act (42 U.S.C. 1396g(e)(1)), assisted living facili14 ties and skilled nursing facilities, intermediate care facili15 ties for individuals with mental retardation, home and 

16 community based settings, and any other setting the Sec17 retary determines to be appropriate. 

18 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

19 under this section, an entity shall— 

20 ‘‘(1) be an institution of higher education (as 

21 defined in section 102 of the Higher Education Act 

22 of 1965 (20 U.S.C. 1002)) that— 

23 ‘‘(A) is accredited by a nationally recog24 nized accrediting agency or association listed 

25 under section 101(c) of the Higher Education 

26 Act of 1965 (20 U.S.C. 1001(c)); and 


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1 ‘‘(B) has established a public-private edu2 cational partnership with a nursing home or 

3 skilled nursing facility, agency or entity pro4 viding home and community based services to 

5 individuals with disabilities, or other long-term 

6 care provider; and 

7 ‘‘(2) submit to the Secretary an application at 

8 such time, in such manner, and containing such in9 formation as the Secretary may require. 

10 ‘‘(c) USE OF FUNDS.—An eligible entity shall use 

11 amounts awarded under a grant under this section to pro12 vide assistance to eligible individuals to offset the cost of 

13 tuition and required fees for enrollment in academic pro14 grams provided by such entity. 

15 ‘‘(d) ELIGIBLE INDIVIDUAL.— 

16 ‘‘(1) ELIGIBILITY.—To be eligible for assistance 

17 under this section, an individual shall be enrolled in 

18 courses provided by a grantee under this subsection 

19 and maintain satisfactory academic progress in such 

20 courses. 

21 ‘‘(2) CONDITION OF ASSISTANCE.—As a condi22 tion of receiving assistance under this section, an in23 dividual shall agree that, following completion of the 

24 assistance period, the individual will work in the 

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1 ices and supports, or chronic care management for 

2 a minimum of 2 years under guidelines set by the 

3 Secretary. 

4 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

5 is authorized to be appropriated to carry out this section, 

6 $10,000,000 for the period of fiscal years 2011 through 

7 2013.’’. 

8 SEC. 433. TRAINING IN GENERAL, PEDIATRIC, AND PUBLIC 

9 HEALTH DENTISTRY. 

10 Part C of Title VII of the Public Health Service Act 

11 (42 U.S.C. 293k et seq.) is amended by— 

12 (1) redesignating section 748, as amended by 

13 section 413 of this Act, as section 749; and 

14 (2) inserting after section 747A, as added by 

15 section 432, the following: 

16 ‘‘SEC. 748. TRAINING IN GENERAL, PEDIATRIC, AND PUBLIC 

17 HEALTH DENTISTRY. 

18 ‘‘(a) SUPPORT AND DEVELOPMENT OF DENTAL

19 TRAINING PROGRAMS.— 

20 ‘‘(1) IN GENERAL.—The Secretary may make 

21 grants to, or enter into contracts with, a school of 

22 dentistry, public or nonprofit private hospital, or a 

23 public or private nonprofit entity which the Sec24 retary has determined is capable of carrying out 

25 such grant or contract— 


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1 ‘‘(A) to plan, develop, and operate, or par2 ticipate in, an approved professional training 

3 program in the field of general dentistry, pedi4 atric dentistry, or public health dentistry for 

5 dental students, residents, practicing dentists, 

6 dental hygienists, or other approved primary 

7 care dental trainees, that emphasizes training 

8 for general, pediatric, or public health dentistry; 

9 ‘‘(B) to provide financial assistance to den10 tal students, residents, practicing dentists, and 

11 dental hygiene students who are in need there12 of, who are participants in any such program, 

13 and who plan to work in the practice of general, 

14 pediatric, public heath dentistry, or dental hy15 giene; 

16 ‘‘(C) to plan, develop, and operate a pro17 gram for the training of oral health care pro18 viders who plan to teach in general, pediatric, 

19 public health dentistry, or dental hygiene; 

20 ‘‘(D) to provide financial assistance in the 

21 form of traineeships and fellowships to dentists 

22 who plan to teach or are teaching in general, 

23 pediatric, or public health dentistry; 

24 ‘‘(E) to meet the costs of projects to estab25 lish, maintain, or improve dental faculty develVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00658 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 opment programs in primary care (which may 

2 be departments, divisions or other units); 

3 ‘‘(F) to meet the costs of projects to estab4 lish, maintain, or improve predoctoral and 

5 postdoctoral training in primary care programs; 

6 ‘‘(G) to create a loan repayment program 

7 for faculty in dental programs; and 

8 ‘‘(H) to provide technical assistance to pe9 diatric training programs in developing and im10 plementing instruction regarding the oral health 

11 status, dental care needs, and risk-based clin12 ical disease management of all pediatric popu13 lations with an emphasis on underserved chil14 dren. 

15 ‘‘(2) FACULTY LOAN REPAYMENT.— 

16 ‘‘(A) IN GENERAL.—A grant or contract 

17 under subsection (a)(1)(G) may be awarded to 

18 a program of general, pediatric, or public health 

19 dentistry described in such subsection to plan, 

20 develop, and operate a loan repayment program 

21 under which— 

22 ‘‘(i) individuals agree to serve full23 time as faculty members; and 

24 ‘‘(ii) the program of general, pediatric 

25 or public health dentistry agrees to pay the 


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1 principal and interest on the outstanding 

2 student loans of the individuals. 

3 ‘‘(B) MANNER OF PAYMENTS.—With re4 spect to the payments described in subpara5 graph (A)(ii), upon completion by an individual 

6 of each of the first, second, third, fourth, and 

7 fifth years of service, the program shall pay an 

8 amount equal to 10, 15, 20, 25, and 30 per9 cent, respectively, of the individual’s student 

10 loan balance as calculated based on principal 

11 and interest owed at the initiation of the agree12 ment. 

13 ‘‘(b) ELIGIBLE ENTITY.—For purposes of this sub14 section, entities eligible for such grants or contracts in 

15 general, pediatric, or public health dentistry shall include 

16 entities that have programs in dental or dental hygiene 

17 schools, or approved residency or advanced education pro18 grams in the practice of general, pediatric, or public health 

19 dentistry. Eligible entities may partner with schools of 

20 public health to permit the education of dental students, 

21 residents, and dental hygiene students for a master’s year 

22 in public health at a school of public health. 

23 ‘‘(c) PRIORITIES IN MAKING AWARDS.—With respect 

24 to training provided for under this section, the Secretary 


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1 shall give priority in awarding grants or contracts to the 

2 following: 

3 ‘‘(1) Qualified applicants that propose collabo4 rative projects between departments of primary care 

5 medicine and departments of general, pediatric, or 

6 public health dentistry. 

7 ‘‘(2) Qualified applicants that have a record of 

8 training the greatest percentage of providers, or that 

9 have demonstrated significant improvements in the 

10 percentage of providers, who enter and remain in 

11 general, pediatric, or public health dentistry. 

12 ‘‘(3) Qualified applicants that have a record of 

13 training individuals who are from a rural or dis14 advantaged background, or from underrepresented 

15 minorities. 

16 ‘‘(4) Qualified applicants that establish formal 

17 relationships with Federally qualified health centers, 

18 rural health centers, or accredited teaching facilities 

19 and that conduct training of students, residents, fel20 lows, or faculty at the center or facility. 

21 ‘‘(5) Qualified applicants that conduct teaching 

22 programs targeting vulnerable populations such as 

23 older adults, homeless individuals, victims of abuse 

24 or trauma, individuals with mental health or subVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00661 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 stance-related disorders, individuals with disabilities, 

2 and individuals with HIV/AIDS. 

3 ‘‘(6) Qualified applicants that include edu4 cational activities in cultural competency and health 

5 literacy. 

6 ‘‘(7) Qualified applicants that provide instruc7 tion regarding the oral health status, dental care 

8 needs, and risk-based clinical disease management of 

9 all populations, with an emphasis on underserved 

10 children. 

11 ‘‘(8) Qualified applicants that intend to estab12 lish a special populations oral health care education 

13 center or training program for the didactic and clin14 ical education of dentists, dental health profes15 sionals, and dental hygienists who plan to teach oral 

16 health care for people with developmental disabil17 ities, cognitive impairment, complex medical prob18 lems, significant physical limitations, and vulnerable 

19 elderly. 

20 ‘‘(d) PREFERENCE IN MAKING AWARDS.—In making 

21 awards of grants or contracts under this section, the Sec22 retary shall give preference to any qualified applicant 

23 that— 

24 ‘‘(1) has a high rate for placing graduates in 

25 practice settings having the principal focus of servVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00662 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 ing in underserved areas or health disparity popu2 lations (including serving patients eligible for Med3 icaid or the Children’s Health Insurance Program, 

4 or those with special health care needs); or 

5 ‘‘(2) during the 2-year period before the fiscal 

6 year for which such an award is sought, has 

7 achieved a significant increase in the rate of placing 

8 graduates in such settings or graduating practi9 tioners who serve health disparity populations in 

10 their practices. 

11 ‘‘(e) APPLICATION.—An eligible entity desiring a 

12 grant under this section shall submit to the Secretary an 

13 application at such time, in such manner, and containing 

14 such information as the Secretary may require. 

15 ‘‘(f) DURATION OF AWARD.—The period during 

16 which payments are made to an entity from an award of 

17 a grant or contract under subsection (a) shall be 5 years. 

18 The provision of such payments shall be subject to annual 

19 approval by the Secretary and subject to the availability 

20 of appropriations for the fiscal year involved to make the 

21 payments. 

22 ‘‘(g) AUTHORIZATIONS OF APPROPRIATIONS.—For 

23 the purpose of carrying out subsections (a) and (b), there 

24 is authorized to be appropriated $30,000,000 for fiscal 


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1 year 2010 and such sums as may be necessary for each 

2 of fiscal years 2011 through 2015. 

3 ‘‘(h) CARRYOVER FUNDS.—An entity that receives an 

4 award under this section may carry over funds from 1 fis5 cal year to another without obtaining approval from the 

6 Secretary. In no case may any funds be carried over pur7 suant to the preceding sentence for more than 3 years.’’. 

8 SEC. 434. ALTERNATIVE DENTAL HEALTH CARE PRO9 VIDERS DEMONSTRATION PROJECT. 

10 Subpart X of part D of title III of the Public Health 

11 Service Act (42 U.S.C. 256f et seq.) is amended by adding 

12 at the end the following: 

13 ‘‘SEC. 340H. DEMONSTRATION PROGRAM. 

14 ‘‘(a) IN GENERAL.— 

15 ‘‘(1) AUTHORIZATION.—The Secretary is au16 thorized to award grants to 15 eligible entities to en17 able such entities to establish a demonstration pro18 gram to establish training programs to train, or to 

19 employ, alternative dental health care providers in 

20 order to increase access to dental health care serv21 ices in rural and other underserved communities. 

22 ‘‘(2) DEFINITION.—The term ‘alternative den23 tal health care providers’ includes community dental 

24 health coordinators, advance practice dental hygien25 ists, independent dental hygienists, supervised dental 


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1 hygienists, primary care physicians, dental thera2 pists, dental health aides, and any other health pro3 fessional that the Secretary determines appropriate. 

4 ‘‘(b) TIMEFRAME.—The demonstration projects fund5 ed under this section shall begin not later than 2 years 

6 after the date of enactment of this section, and shall con7 clude not later than 7 years after such date of enactment. 

8 ‘‘(c) ELIGIBLE ENTITIES.—To be eligible to receive 

9 a grant under subsection (a), an entity shall— 

10 ‘‘(1) be— 

11 ‘‘(A) an institution of higher education, in12 cluding a community college; 

13 ‘‘(B) a public-private partnership; 

14 ‘‘(C) a federally qualified health center; 

15 ‘‘(D) an Indian Health Service facility or a 

16 tribe or tribal organization (as such terms are 

17 defined in section 4 of the Indian Self-Deter18 mination and Education Assistance Act); 

19 ‘‘(E) a State or county public health clinic, 

20 a health facility operated by an Indian tribe or 

21 tribal organization, or urban Indian organiza22 tion providing dental services; or 

23 ‘‘(F) a public hospital or health system; 

24 ‘‘(2) be within a program accredited by the 

25 Commission on Dental Accreditation or within a 


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1 dental education program in an accredited institu2 tion; and 

3 ‘‘(3) shall submit an application to the Sec4 retary at such time, in such manner, and containing 

5 such information as the Secretary may require. 

6 ‘‘(d) ADMINISTRATIVE PROVISIONS.— 

7 ‘‘(1) AMOUNT OF GRANT.—Each grant under 

8 this section shall be in an amount that is not less 

9 than $4,000,000 for the 5-year period during which 

10 the demonstration project being conducted. 

11 ‘‘(2) DISBURSEMENT OF FUNDS.— 

12 ‘‘(A) PRELIMINARY DISBURSEMENTS.—Be13 ginning 1 year after the enactment of this sec14 tion, the Secretary may disperse to any entity 

15 receiving a grant under this section not more 

16 than 20 percent of the total funding awarded to 

17 such entity under such grant, for the purpose 

18 of enabling the entity to plan the demonstration 

19 project to be conducted under such grant. 

20 ‘‘(B) SUBSEQUENT DISBURSEMENTS.—The 

21 remaining amount of grant funds not dispersed 

22 under subparagraph (A) shall be dispersed such 

23 that not less than 15 percent of such remaining 

24 amount is dispersed each subsequent year. 


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1 ‘‘(e) COMPLIANCE WITH STATE REQUIREMENTS.— 

2 Each entity receiving a grant under this section shall cer3 tify that it is in compliance with all applicable State licens4 ing requirements. 

5 ‘‘(f) EVALUATION.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall con7 tract with the Director of the Institute of Medicine 

8 (referred to in this subsection as the ‘Director’) to 

9 conduct a study of the demonstration programs con10 ducted under this section that shall provide analysis, 

11 based upon quantitative and qualitative data, re12 garding access to dental health care in the United 

13 States. 

14 ‘‘(2) DATA COLLECTION.— 

15 ‘‘(A) BASELINE DATA.—The Director shall 

16 gather data from each demonstration project 

17 not later than 24 months after the commence18 ment of the project, which shall serve as base19 line data for the study. 

20 ‘‘(B) COMPARISON DATA.—The Director 

21 shall begin collecting data from each dem22 onstration project 1 year after such project con23 cludes, and shall conclude such data collection 

24 not later than 18 months after the conclusion 

25 of the project. 


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1 ‘‘(g) CLARIFICATION REGARDING DENTAL HEALTH

2 AIDE PROGRAM.—Nothing in this section shall prohibit a 

3 dental health aide training program approved by the In4 dian Health Service from being eligible for a grant under 

5 this section. 

6 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

7 is authorized to be appropriated such sums as may be nec8 essary to carry out this section.’’. 

9 SEC. 435. GERIATRIC EDUCATION AND TRAINING; CAREER 

10 AWARDS; COMPREHENSIVE GERIATRIC EDU11 CATION. 

12 (a) WORKFORCE DEVELOPMENT; CAREER

13 AWARDS.—Section 753 of the Public Health Service Act 

14 (42 U.S.C. 294c) is amended by adding at the end the 

15 following: 

16 ‘‘(d) GERIATRIC WORKFORCE DEVELOPMENT.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall award 

18 grants or contracts under this subsection to entities 

19 that operate a geriatric education center pursuant to 

20 subsection (a)(1). 

21 ‘‘(2) APPLICATION.—To be eligible for an 

22 award under paragraph (1), an entity described in 

23 such paragraph shall submit to the Secretary an ap24 plication at such time, in such manner, and conVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00668 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 taining such information as the Secretary may re2 quire. 

3 ‘‘(3) USE OF FUNDS.—Amounts awarded under 

4 a grant or contract under paragraph (1) shall be 

5 used to— 

6 ‘‘(A) carry out the fellowship program de7 scribed in paragraph (4); and 

8 ‘‘(B) carry out 1 of the 2 activities de9 scribed in paragraph (5). 

10 ‘‘(4) FELLOWSHIP PROGRAM.— 

11 ‘‘(A) IN GENERAL.—Pursuant to para12 graph (3), a geriatric education center that re13 ceives an award under this subsection shall use 

14 such funds to offer short-term intensive courses 

15 (referred to in this subsection as a ‘fellowship’) 

16 that focus on geriatrics, chronic care manage17 ment, and long-term care that provide supple18 mental training for faculty members in medical 

19 schools and other health professions schools 

20 with programs in psychology, pharmacy, nurs21 ing, social work, dentistry, public health, allied 

22 health, or other health disciplines, as approved 

23 by the Secretary. Such a fellowship shall be 

24 open to current faculty, and appropriately 

25 credentialed volunteer faculty and practitioners, 


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1 who do not have formal training in geriatrics, 

2 to upgrade their knowledge and clinical skills 

3 for the care of older adults and adults with 

4 functional limitations and to enhance their 

5 interdisciplinary teaching skills. 

6 ‘‘(B) LOCATION.—A fellowship shall be of7 fered either at the geriatric education center 

8 that is sponsoring the course, in collaboration 

9 with other geriatric education centers, or at 

10 medical schools, schools of dentistry, schools of 

11 nursing, schools of pharmacy, schools of social 

12 work, graduate programs in psychology, or al13 lied health and other health professions schools 

14 approved by the Secretary with which the geri15 atric education centers are affiliated. 

16 ‘‘(C) CME CREDIT.—Participation in a fel17 lowship under this paragraph shall be accepted 

18 with respect to complying with continuing 

19 health profession education requirements. As a 

20 condition of such acceptance, the recipient shall 

21 agree to subsequently provide a minimum of 18 

22 hours of voluntary instructional support 

23 through a geriatric education center that is pro24 viding clinical training to students or trainees 

25 in long-term care settings. 


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1 ‘‘(5) ADDITIONAL REQUIRED ACTIVITIES DE2 SCRIBED.—Pursuant to paragraph (3), a geriatric 

3 education center that receives an award under this 

4 subsection shall use such funds to carry out 1 of the 

5 following 2 activities. 

6 ‘‘(A) FAMILY CAREGIVER AND DIRECT

7 CARE PROVIDER TRAINING.—A geriatric edu8 cation center that receives an award under this 

9 subsection shall offer at least 2 courses each 

10 year, at no charge or nominal cost, to family 

11 caregivers and direct care providers that are de12 signed to provide practical training for sup13 porting frail elders and individuals with disabil14 ities. The Secretary shall require such Centers 

15 to work with appropriate community partners 

16 to develop training program content and to 

17 publicize the availability of training courses in 

18 their service areas. All family caregiver and di19 rect care provider training programs shall in20 clude instruction on the management of psycho21 logical and behavioral aspects of dementia, com22 munication techniques for working with individ23 uals who have dementia, and the appropriate, 

24 safe, and effective use of medications for older 

25 adults. 


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1 ‘‘(B) INCORPORATION OF BEST PRAC2 TICES.—A geriatric education center that re3 ceives an award under this subsection shall de4 velop and include material on depression and 

5 other mental disorders common among older 

6 adults, medication safety issues for older adults, 

7 and management of the psychological and be8 havioral aspects of dementia and communica9 tion techniques with individuals who have de10 mentia in all training courses, where appro11 priate. 

12 ‘‘(6) TARGETS.—A geriatric education center 

13 that receives an award under this subsection shall 

14 meet targets approved by the Secretary for providing 

15 geriatric training to a certain number of faculty or 

16 practitioners during the term of the award, as well 

17 as other parameters established by the Secretary, in18 cluding guidelines for the content of the fellowships. 

19 ‘‘(7) AMOUNT OF AWARD.—An award under 

20 this subsection shall be in an amount of $150,000. 

21 Not more than 24 geriatric education centers may 

22 receive an award under this subsection. 

23 ‘‘(8) MAINTENANCE OF EFFORT.—A geriatric 

24 education center that receives an award under this 

25 subsection shall provide assurances to the Secretary 


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1 that funds provided to the geriatric education center 

2 under this subsection will be used only to supple3 ment, not to supplant, the amount of Federal, State, 

4 and local funds otherwise expended by the geriatric 

5 education center. 

6 ‘‘(9) AUTHORIZATION OF APPROPRIATIONS.—In 

7 addition to any other funding available to carry out 

8 this section, there is authorized to be appropriated 

9 to carry out this subsection, $10,800,000 for the pe10 riod of fiscal year 2011 through 2014. 

11 ‘‘(e) GERIATRIC CAREER INCENTIVE AWARDS.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall award 

13 grants or contracts under this section to individuals 

14 described in paragraph (2) to foster greater interest 

15 among a variety of health professionals in entering 

16 the field of geriatrics, long-term care, and chronic 

17 care management. 

18 ‘‘(2) ELIGIBLE INDIVIDUALS.—To be eligible to 

19 received an award under paragraph (1), an indi20 vidual shall— 

21 ‘‘(A) be an advanced practice nurse, a clin22 ical social worker, a pharmacist, or student of 

23 psychology who is pursuing a doctorate or other 

24 advanced degree in geriatrics or related fields in 

25 an accredited health professions school; and 


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1 ‘‘(B) submit to the Secretary an applica2 tion at such time, in such manner, and con3 taining such information as the Secretary may 

4 require. 

5 ‘‘(3) CONDITION OF AWARD.—As a condition of 

6 receiving an award under this subsection, an indi7 vidual shall agree that, following completion of the 

8 award period, the individual will teach or practice in 

9 the field of geriatrics, long-term care, or chronic 

10 care management for a minimum of 5 years under 

11 guidelines set by the Secretary. 

12 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

13 There is authorized to be appropriated to carry out 

14 this subsection, $10,000,000 for the period of fiscal 

15 years 2011 through 2013.’’. 

16 (b) EXPANSION OF ELIGIBILITY FOR GERIATRIC

17 ACADEMIC CAREER AWARDS; PAYMENT TO INSTITU18 TION.—Section 753(c) of the Public Health Service Act 

19 294(c)) is amended— 

20 (1) by redesignating paragraphs (4) and (5) as 

21 paragraphs (5) and (6), respectively; 

22 (2) by striking paragraph (2) through para23 graph (3) and inserting the following: 


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1 ‘‘(2) ELIGIBLE INDIVIDUALS.—To be eligible to 

2 receive an Award under paragraph (1), an individual 

3 shall— 

4 ‘‘(A) be board certified or board eligible in 

5 internal medicine, family practice, psychiatry, 

6 or licensed dentistry, or have completed any re7 quired training in a discipline and employed in 

8 an accredited health professions school that is 

9 approved by the Secretary; 

10 ‘‘(B) have completed an approved fellow11 ship program in geriatrics; and 

12 ‘‘(C) have a junior (non-tenured) faculty 

13 appointment at an accredited (as determined by 

14 the Secretary) school of medicine, osteopathic 

15 medicine, nursing, social work, psychology, den16 tistry, pharmacy, or other allied health dis17 ciplines in an accredited health professions 

18 school that is approved by the Secretary. 

19 ‘‘(3) LIMITATIONS.—No Award under para20 graph (1) may be made to an eligible individual un21 less the individual— 

22 ‘‘(A) has submitted to the Secretary an ap23 plication, at such time, in such manner, and 

24 containing such information as the Secretary 


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1 may require, and the Secretary has approved 

2 such application; 

3 ‘‘(B) provides, in such form and manner as 

4 the Secretary may require, assurances that the 

5 individual will meet the service requirement de6 scribed in paragraph (6); and 

7 ‘‘(C) provides, in such form and manner as 

8 the Secretary may require, assurances that the 

9 individual has a full-time faculty appointment 

10 in a health professions institution and docu11 mented commitment from such institution to 

12 spend 75 percent of the total time of such indi13 vidual on teaching and developing skills in 

14 interdisciplinary education in geriatrics. 

15 ‘‘(4) MAINTENANCE OF EFFORT.—An eligible 

16 individual that receives an Award under paragraph 

17 (1) shall provide assurances to the Secretary that 

18 funds provided to the eligible individual under this 

19 subsection will be used only to supplement, not to 

20 supplant, the amount of Federal, State, and local 

21 funds otherwise expended by the eligible individual.’’; 

22 and 

23 (3) in paragraph (5), as so designated— 

24 (A) in subparagraph (A)— 


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1 (i) by inserting ‘‘for individuals who 

2 are physicians’’ after ‘‘this section’’; and 

3 (ii) by inserting after the period at 

4 the end the following: ‘‘The Secretary shall 

5 determine the amount of an Award under 

6 this section for individuals who are not 

7 physicians.’’; and 

8 (B) by adding at the end the following: 

9 ‘‘(C) PAYMENT TO INSTITUTION.—The 

10 Secretary shall transfer funds awarded to an in11 dividual under this section to the institution 

12 where such individual will carry out the award, 

13 in order to facilitate financial management of 

14 the reward pursuant to guidelines of the Health 

15 Resources and Services Administration.’’. 

16 (c) COMPREHENSIVE GERIATRIC EDUCATION.—Sec17 tion 855 of the Public Health Service Act (42 U.S.C. 298) 

18 is amended— 

19 (1) in subsection (b)— 

20 (A) in paragraph (3), by striking ‘‘or’’ at 

21 the end; 

22 (B) in paragraph (4), by striking the pe23 riod and inserting ‘‘; or’’; and 

24 (C) by adding at the end the following: 


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1 ‘‘(5) establish traineeships for individuals who 

2 are preparing for advanced education nursing de3 grees in geriatric nursing, long-term care, gero-psy4 chiatric nursing or other nursing areas that spe5 cialize in the care of the elderly population.’’; and 

6 (2) in subsection (e), by striking ‘‘2003 through 

7 2007’’ and inserting ‘‘2010 through 2014’’. 

8 SEC. 436. MENTAL AND BEHAVIORAL HEALTH EDUCATION 

9 AND TRAINING GRANTS. 

10 (a) IN GENERAL.—Part D of title VII (42 U.S.C. 

11 294 et seq.) is amended by— 

12 (1) striking section 757; 

13 (2) redesignating section 756 (as amended by 

14 section 413) as section 757; and 

15 (3) inserting after section 755 the following: 

16 ‘‘SEC. 756. MENTAL AND BEHAVIORAL HEALTH EDUCATION 

17 AND TRAINING GRANTS. 

18 ‘‘(a) GRANTS AUTHORIZED.—The Secretary may 

19 award grants to eligible institutions of higher education 

20 to support the recruitment of students for, and education 

21 and clinical experience of the students in— 

22 ‘‘(1) baccalaureate, master’s, and doctoral de23 gree programs of social work, as well as the develop24 ment of faculty in social work; 


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1 ‘‘(2) accredited master’s, doctoral, internship, 

2 and post-doctoral residency programs of psychology 

3 for the development and implementation of inter4 disciplinary training of psychology graduate students 

5 for providing behavioral and mental health services, 

6 including substance abuse prevention and treatment 

7 services; 

8 ‘‘(3) accredited institutions of higher education 

9 or accredited professional training programs that are 

10 establishing or expanding internships or other field 

11 placement programs in child and adolescent mental 

12 health in psychiatry, psychology, school psychology, 

13 behavioral pediatrics, psychiatric nursing, social 

14 work, school social work, substance abuse prevention 

15 and treatment, marriage and family therapy, school 

16 counseling, or professional counseling; and 

17 ‘‘(4) State-licensed mental health nonprofit and 

18 for-profit organizations to enable such organizations 

19 to pay for programs for preservice or in-service 

20 training of paraprofessional child and adolescent 

21 mental health workers. 

22 ‘‘(b) ELIGIBILITY REQUIREMENTS.—To be eligible 

23 for a grant under this section, an institution shall dem24 onstrate— 


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1 ‘‘(1) participation in the institutions’ programs 

2 of individuals and groups from different racial, eth3 nic, cultural, geographic, religious, linguistic, and 

4 class backgrounds, and different genders and sexual 

5 orientations; 

6 ‘‘(2) knowledge and understanding of the con7 cerns of the individuals and groups described in sub8 section (a); 

9 ‘‘(3) any internship or other field placement 

10 program assisted under the grant will prioritize cul11 tural and linguistic competency; 

12 ‘‘(4) the institution will provide to the Secretary 

13 such data, assurances, and information as the Sec14 retary may require; and 

15 ‘‘(5) with respect to any violation of the agree16 ment between the Secretary and the institution, the 

17 institution will pay such liquidated damages as pre18 scribed by the Secretary by regulation. 

19 ‘‘(c) INSTITUTIONAL REQUIREMENT.—For grants 

20 authorized under subsection (a)(1), at least 4 of the grant 

21 recipients shall be historically black colleges or universities 

22 or other minority-serving institutions. 

23 ‘‘(d) PRIORITY.— 


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1 ‘‘(1) In selecting the grant recipients in social 

2 work under subsection (a)(1), the Secretary shall 

3 give priority to applicants that— 

4 ‘‘(A) are accredited by the Council on So5 cial Work Education; 

6 ‘‘(B) have a graduation rate of not less 

7 than 80 percent for social work students; and 

8 ‘‘(C) exhibit an ability to recruit social 

9 workers from and place social workers in areas 

10 with a high need and high demand population. 

11 ‘‘(2) In selecting the grant recipients in grad12 uate psychology under subsection (a)(2), the Sec13 retary shall give priority to institutions in which 

14 training focuses on the needs of vulnerable groups 

15 such as older adults and children, individuals with 

16 mental health or substance-related disorders, victims 

17 of abuse or trauma and of combat stress disorders 

18 such as posttraumatic stress disorder and traumatic 

19 brain injuries, homeless individuals, chronically ill 

20 persons, and their families. 

21 ‘‘(3) In selecting the grant recipients in profes22 sional training programs in child and adolescent 

23 mental health under subsection (a)(3), the Secretary 

24 shall give priority to applicants that— 


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1 ‘‘(A) have demonstrated the ability to col2 lect data on the number of students trained in 

3 child and adolescent mental health and the pop4 ulations served by such students after gradua5 tion; 

6 ‘‘(B) have demonstrated familiarity with 

7 evidence-based methods in child and adolescent 

8 mental health services, including substance 

9 abuse prevention and treatment services; 

10 ‘‘(C) have programs designed to increase 

11 the number of paraprofessionals serving high12 priority populations and to applicants who come 

13 from high-priority communities and plan to 

14 serve in Health Professional Shortage Areas, 

15 Medically Underserved Areas, or Medically Un16 derserved Populations; and 

17 ‘‘(D) offer curriculum taught collabo18 ratively with a family on the consumer and 

19 family lived experience or the importance of 

20 family-professional partnership. 

21 ‘‘(4) In selecting the grant recipients to offer 

22 preservice or in-service training of paraprofessional 

23 child and adolescent mental health workers under 

24 subsection (a)(4), the Secretary shall give priority to 

25 applicants that— 


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1 ‘‘(A) have demonstrated the ability to col2 lect data on the number of paraprofessional 

3 child and adolescent mental health workers 

4 trained by the applicant and the populations 

5 served by these workers after the completion of 

6 the training; 

7 ‘‘(B) have demonstrated familiarity with 

8 evidence-based methods in child and adolescent 

9 mental health services; 

10 ‘‘(C) have programs designed to increase 

11 the number of professionals serving high-pri12 ority populations, or who come from high-pri13 ority communities and plan to serve medically 

14 underserved populations or in health profes15 sional shortage areas or medically underserved 

16 areas; 

17 ‘‘(D) offer curriculum taught collabo18 ratively with a family on the consumer and 

19 family lived experience or the importance of 

20 family-paraprofessional partnership; and 

21 ‘‘(E) provide services through a community 

22 mental health program described in section 

23 1913(b)(1). 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATION.—For the 

2 fiscal years 2010 through 2013, there is authorized to be 

3 appropriated to carry out this section— 

4 ‘‘(1) $8,000,000 for training in social work in 

5 subsection (a)(1); 

6 ‘‘(2) $12,000,000 for training in graduate psy7 chology in subsection (a)(2), of which not less than 

8 $10,000,000 shall be allocated for doctoral, 

9 postdoctoral, and internship level training; 

10 ‘‘(3) $10,000,000 for training in professional 

11 child and adolescent mental health in subsection 

12 (a)(3); and 

13 ‘‘(4) $5,000,000 for training in paraprofes14 sional child and adolescent work in subsection 

15 (a)(4).’’. 

16 (b) CONFORMING AMENDMENTS.—Section 757(b)(2) 

17 of the Public Health Service Act, as redesignated by sub18 section (a), is amended by striking ‘‘sections 751(a)(1)(A), 

19 751(a)(1)(B), 753(b), 754(3)(A), and 755(b)’’ and insert20 ing ‘‘sections 751(b), 753(b), and 755(b)’’. 


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1 SEC. 437. CULTURAL COMPETENCY, PREVENTION AND PUB2 LIC HEALTH AND INDIVIDUALS WITH DIS3 ABILITIES TRAINING. 

4 Part B of title VII of the Public Health Service Act 

5 (42 U.S.C. 293 et seq.) is amended by adding at the end 

6 the following: 

7 ‘‘SEC. 742. CULTURAL COMPETENCY, PREVENTION AND 

8 PUBLIC HEALTH AND INDIVIDUALS WITH DIS9 ABILITIES TRAINING. 

10 ‘‘(a) IN GENERAL.—The Secretary shall support the 

11 development, evaluation, and dissemination of model cur12 ricula for cultural competency, prevention, and public 

13 health proficiency and aptitude for working with individ14 uals with disabilities training for use in health professions 

15 schools and continuing education programs, and for other 

16 purposes determined appropriate by the Secretary. 

17 ‘‘(b) CURRICULA.— 

18 ‘‘(1) COLLABORATION.—In carrying out sub19 section (a), the Secretary shall collaborate with 

20 health professional societies, licensing and accredita21 tion entities, health professions schools, and experts 

22 in minority health and cultural competency, preven23 tion and public health and disability groups, commu24 nity-based organizations, and other organizations as 

25 determined appropriate by the Secretary. 


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1 ‘‘(2) FOCUS.—Curricula developed under this 

2 section shall include a focus on cultural competency 

3 measures, prevention and public health competency 

4 measures, and working with individuals with disabil5 ities competency measures. In addition, cultural 

6 competency, prevention and public health pro7 ficiency, and working with individuals with disabil8 ities aptitude self-assessment methodology for health 

9 providers, systems, and institutions. 

10 ‘‘(c) DISSEMINATION.— 

11 ‘‘(1) IN GENERAL.—Model curricula developed 

12 under this section shall be disseminated through the 

13 Internet Clearinghouse under section 270 and such 

14 other means as determined appropriate by the Sec15 retary. 

16 ‘‘(2) EVALUATION.—The Secretary shall evalu17 ate the adoption and the implementation of cultural 

18 competency, prevention and public health, and work19 ing with individuals with a disability training cur20 ricula, and the facilitate inclusion of these com21 petency measures in quality measurement systems as 

22 appropriate. 

23 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

24 is authorized to be appropriated to carry out this section 


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1 such sums as necessary for each of the fiscal years 2010 

2 through 2015.’’. 

3 SEC. 438. ADVANCED NURSING EDUCATION GRANTS. 

4 Section 811 of the Public Health Service Act (42 

5 U.S.C. 296j) is amended— 

6 (1) in subsection (c)— 

7 (A) in the subsection heading, by striking 

8 ‘‘AND NURSE MIDWIFERY PROGRAMS’’; and 

9 (B) by striking ‘‘and nurse midwifery’’; 

10 (2) in subsection (f)— 

11 (A) by striking paragraph (2); and 

12 (B) by redesignating paragraph (3) as 

13 paragraph (2); and 

14 (3) by redesignating subsections (d), (e), and 

15 (f) as subsections (e), (f), and (g), respectively; and 

16 (4) by inserting after subsection (c), the fol17 lowing: 

18 ‘‘(d) AUTHORIZED NURSE-MIDWIFERY PROGRAMS.— 

19 Midwifery programs that are eligible for support under 

20 this section are educational programs that— 

21 ‘‘(1) have as their objective the education of 

22 midwives, who will upon completion of their studies 

23 in such programs, be qualified to effectively provide 

24 primary health care services to women at locations 

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1 cluding acute care facilities, ambulatory care facili2 ties, birth centers, personal residences, and other 

3 settings as authorized by State or Federal law; and 

4 ‘‘(2) are accredited by the American College of 

5 Nurse-Midwives Accreditation Commission for Mid6 wifery Education.’’. 

7 SEC. 439. NURSE EDUCATION, PRACTICE, AND RETENTION 

8 GRANTS. 

9 (a) IN GENERAL.—Section 831 of the Public Health 

10 Service Act (42 U.S.C. 296p) is amended— 

11 (1) in the section heading, by striking ‘‘RETEN12 TION’’ and inserting ‘‘QUALITY’’; 

13 (2) in subsection (a)— 

14 (A) in paragraph (1), by adding ‘‘or’’ after 

15 the semicolon; 

16 (B) by striking paragraph (2); and 

17 (C) by redesignating paragraph (3) as 

18 paragraph (2); 

19 (3) in subsection (b)(3), by striking ‘‘managed 

20 care, quality improvement’’ and inserting ‘‘coordi21 nated care’’; 

22 (4) in subsection (g), by inserting ‘‘, as defined 

23 in section 801(2),’’ after ‘‘school of nursing’’; and 

24 (5) in subsection (h), by striking ‘‘2003 

25 through 2007’’ and inserting ‘‘2010 through 2014’’. 


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1 (b) NURSE RETENTION GRANTS.—Title VIII of the 

2 Public Health Service Act is amended by inserting after 

3 section 831 (42 U.S.C. 296b) the following: 

4 ‘‘SEC. 831A. NURSE RETENTION GRANTS. 

5 ‘‘(a) RETENTION PRIORITY AREAS.—The Secretary 

6 may award grants to, and enter into contracts with, eligi7 ble entities to enhance the nursing workforce by initiating 

8 and maintaining nurse retention programs pursuant to 

9 subsection (b) or (c). 

10 ‘‘(b) GRANTS FOR CAREER LADDER PROGRAM.—The 

11 Secretary may award grants to, and enter into contracts 

12 with, eligible entities for programs— 

13 ‘‘(1) to promote career advancement for individ14 uals including licensed practical nurses, licensed vo15 cational nurses, certified nurse assistants, home 

16 health aides, diploma degree or associate degree 

17 nurses, to become baccalaureate prepared registered 

18 nurses or advanced education nurses in order to 

19 meet the needs of the registered nurse workforce; 

20 ‘‘(2) developing and implementing internships 

21 and residency programs in collaboration with an ac22 credited school of nursing, as defined by section 

23 801(2), to encourage mentoring and the development 

24 of specialties; or 


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1 ‘‘(3) to assist individuals in obtaining education 

2 and training required to enter the nursing profession 

3 and advance within such profession, such as by pro4 viding career counseling and mentoring. 

5 ‘‘(c) ENHANCING PATIENT CARE DELIVERY SYS6 TEMS.— 

7 ‘‘(1) GRANTS.—The Secretary may award 

8 grants to eligible entities to improve the retention of 

9 nurses and enhance patient care that is directly re10 lated to nursing activities by enhancing collaboration 

11 and communication among nurses and other health 

12 care professionals, and by promoting nurse involve13 ment in the organizational and clinical decision-mak14 ing processes of a health care facility. 

15 ‘‘(2) PRIORITY.—In making awards of grants 

16 under this subsection, the Secretary shall give pref17 erence to applicants that have not previously re18 ceived an award under this subsection (or section 

19 831(c) as such section existed on the day before the 

20 date of enactment of this section). 

21 ‘‘(3) CONTINUATION OF AN AWARD.—The Sec22 retary shall make continuation of any award under 

23 this subsection beyond the second year of such 

24 award contingent on the recipient of such award 

25 having demonstrated to the Secretary measurable 


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1 and substantive improvement in nurse retention or 

2 patient care. 

3 ‘‘(d) OTHER PRIORITY AREAS.—The Secretary may 

4 award grants to, or enter into contracts with, eligible enti5 ties to address other areas that are of high priority to 

6 nurse retention, as determined by the Secretary. 

7 ‘‘(e) REPORT.—The Secretary shall submit to the 

8 Congress before the end of each fiscal year a report on 

9 the grants awarded and the contracts entered into under 

10 this section. Each such report shall identify the overall 

11 number of such grants and contracts and provide an ex12 planation of why each such grant or contract will meet 

13 the priority need of the nursing workforce. 

14 ‘‘(f) ELIGIBLE ENTITY.—For purposes of this sec15 tion, the term ‘eligible entity’ includes an accredited school 

16 of nursing, as defined by section 801(2), a health care fa17 cility, or a partnership of such a school and facility. 

18 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

19 are authorized to be appropriated to carry out this section 

20 such sums as may be necessary for each of fiscal years 

21 2010 through 2012.’’. 

22 SEC. 440. LOAN REPAYMENT AND SCHOLARSHIP PROGRAM. 

23 (a) LOAN REPAYMENTS AND SCHOLARSHIPS.—Sec24 tion 846(a)(3) of the Public Health Service Act (42 U.S.C. 

25 297n(a)(3)) is amended by inserting before the semicolon 


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1 the following: ‘‘, or in a accredited school of nursing, as 

2 defined by section 801(2), as nurse faculty’’. 

3 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

4 Title VIII (42 U.S.C. 296 et seq.) is amended— 

5 (1) by redesignating section 810 (relating to 

6 prohibition against discrimination by schools on the 

7 basis of sex) as section 809 and moving such section 

8 so that it follows section 808; 

9 (2) in sections 835, 836, 838, 840, and 842, by 

10 striking the term ‘‘this subpart’’ each place it ap11 pears and inserting ‘‘this part’’; 

12 (3) in section 836(h), by striking the last sen13 tence; 

14 (4) in section 836, by redesignating subsection 

15 (l) as subsection (k); 

16 (5) in section 839, by striking ‘‘839’’ and all 

17 that follows through ‘‘(a)’’ and inserting ‘‘839. (a)’’; 

18 (6) in section 835(b), by striking ‘‘841’’ each 

19 place it appears and inserting ‘‘871’’; 

20 (7) by redesignating section 841 as section 871, 

21 moving part F to the end of the title, and redesig22 nating such part as part I; 

23 (8) in part G— 

24 (A) by redesignating section 845 as section 

25 851; and 


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1 (B) by redesignating part G as part F; 

2 (9) in part H— 

3 (A) by redesignating sections 851 and 852 

4 as sections 861 and 862, respectively; and 

5 (B) by redesignating part H as part G; 

6 and 

7 (10) in part I— 

8 (A) by redesignating section 855, as 

9 amended by section 435, as section 865; and 

10 (B) by redesignating part I as part H. 

11 SEC. 441. NURSE FACULTY LOAN PROGRAM. 

12 (a) IN GENERAL.—Section 846A of the Public 

13 Health Service Act (42 U.S.C. 297n–1) is amended— 

14 (1) in subsection (a)— 

15 (A) in the subsection heading, by striking 

16 ‘‘ESTABLISHMENT’’ and inserting ‘‘SCHOOL OF

17 NURSING STUDENT LOAN FUND’’; and 

18 (B) by inserting ‘‘accredited’’ after ‘‘agree19 ment with any’’; 

20 (2) in subsection (c)— 

21 (A) in paragraph (2), by striking 

22 ‘‘$30,000’’ and all that follows through the 

23 semicolon and inserting ‘‘$35,500, during fiscal 

24 years 2010 and 2011 fiscal years (after fiscal 

25 year 2011, such amounts shall be adjusted to 


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1 provide for a cost-of-attendance increase for the 

2 yearly loan rate and the aggregate loan;’’; and 

3 (B) in paragraph (3)(A), by inserting ‘‘an 

4 accredited’’ after ‘‘faculty member in’’; 

5 (3) in subsection (e), by striking ‘‘a school’’ and 

6 inserting ‘‘an accredited school’’; and 

7 (4) in subsection (f), by striking ‘‘2003 through 

8 2007’’ and inserting ‘‘2010 through 2014’’. 

9 (b) ELIGIBLE INDIVIDUAL STUDENT LOAN REPAY10 MENT.—Title VIII of the Public Health Service Act is 

11 amended by inserting after section 846A (42 U.S.C. 

12 297n–1) the following: 

13 ‘‘SEC. 847. ELIGIBLE INDIVIDUAL STUDENT LOAN REPAY14 MENT. 

15 ‘‘(a) IN GENERAL.—The Secretary, acting through 

16 the Administrator of the Health Resources and Services 

17 Administration, may enter into an agreement with eligible 

18 individuals for the repayment of education loans, in ac19 cordance with this section, to increase the number of 

20 qualified nursing faculty. 

21 ‘‘(b) AGREEMENTS.—Each agreement entered into 

22 under this subsection shall require that the eligible indi23 vidual shall serve as a full-time member of the faculty of 

24 an accredited school of nursing, for a total period, in the 


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1 aggregate, of at least 4 years during the 6-year period be2 ginning on the later of— 

3 ‘‘(1) the date on which the individual receives 

4 a master’s or doctorate nursing degree from an ac5 credited school of nursing; or 

6 ‘‘(2) the date on which the individual enters 

7 into an agreement under this subsection. 

8 ‘‘(c) AGREEMENT PROVISIONS.—Agreements entered 

9 into pursuant to subsection (b) shall be entered into on 

10 such terms and conditions as the Secretary may deter11 mine, except that— 

12 ‘‘(1) not more than 10 months after the date on 

13 which the 6-year period described under subsection 

14 (b) begins, but in no case before the individual 

15 starts as a full-time member of the faculty of an ac16 credited school of nursing the Secretary shall begin 

17 making payments, for and on behalf of that indi18 vidual, on the outstanding principal of, and interest 

19 on, any loan of that individual obtained to pay for 

20 such degree; 

21 ‘‘(2) for an individual who has completed a 

22 master’s in nursing or equivalent degree in nurs23 ing— 

24 ‘‘(A) payments may not exceed $10,000 

25 per calendar year; and 


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1 ‘‘(B) total payments may not exceed 

2 $40,000 during the 2010 and 2011 fiscal years 

3 (after fiscal year 2011, such amounts shall be 

4 adjusted to provide for a cost-of-attendance in5 crease for the yearly loan rate and the aggre6 gate loan); and 

7 ‘‘(3) for an individual who has completed a doc8 torate or equivalent degree in nursing— 

9 ‘‘(A) payments may not exceed $20,000 

10 per calendar year; and 

11 ‘‘(B) total payments may not exceed 

12 $80,000 during the 2010 and 2011 fiscal years 

13 (adjusted for subsequent fiscal years as pro14 vided for in the same manner as in paragraph 

15 (2)(B)). 

16 ‘‘(d) BREACH OF AGREEMENT.— 

17 ‘‘(1) IN GENERAL.—In the case of any agree18 ment made under subsection (b), the individual is 

19 liable to the Federal Government for the total 

20 amount paid by the Secretary under such agree21 ment, and for interest on such amount at the max22 imum legal prevailing rate, if the individual fails to 

23 meet the agreement terms required under such sub24 section. 


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1 ‘‘(2) WAIVER OR SUSPENSION OF LIABILITY.— 

2 In the case of an individual making an agreement 

3 for purposes of paragraph (1), the Secretary shall 

4 provide for the waiver or suspension of liability 

5 under such paragraph if compliance by the indi6 vidual with the agreement involved is impossible or 

7 would involve extreme hardship to the individual or 

8 if enforcement of the agreement with respect to the 

9 individual would be unconscionable. 

10 ‘‘(3) DATE CERTAIN FOR RECOVERY.—Subject 

11 to paragraph (2), any amount that the Federal Gov12 ernment is entitled to recover under paragraph (1) 

13 shall be paid to the United States not later than the 

14 expiration of the 3-year period beginning on the date 

15 the United States becomes so entitled. 

16 ‘‘(4) AVAILABILITY.—Amounts recovered under 

17 paragraph (1) shall be available to the Secretary for 

18 making loan repayments under this section and shall 

19 remain available for such purpose until expended. 

20 ‘‘(e) ELIGIBLE INDIVIDUAL DEFINED.—For pur21 poses of this section, the term ‘eligible individual’ means 

22 an individual who— 

23 ‘‘(1) is a United States citizen, national, or law24 ful permanent resident; 


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1 ‘‘(2) holds an unencumbered license as a reg2 istered nurse; and 

3 ‘‘(3) has either already completed a master’s or 

4 doctorate nursing program at an accredited school of 

5 nursing or is currently enrolled on a full-time or 

6 part-time basis in such a program. 

7 ‘‘(f) PRIORITY.—For the purposes of this section and 

8 section 846A, funding priority will be awarded to School 

9 of Nursing Student Loans that support doctoral nursing 

10 students or Individual Student Loan Repayment that sup11 port doctoral nursing students. 

12 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 such sums as may be necessary for each of fiscal years 

15 2010 through 2014.’’. 

16 SEC. 442. AUTHORIZATION OF APPROPRIATIONS FOR 

17 PARTS B THROUGH D OF TITLE VIII. 

18 Section 871 of the Public Health Service Act, as re19 designated and moved by section 440, is amended to read 

20 as follows: 

21 ‘‘SEC. 871. AUTHORIZATION OF APPROPRIATIONS. 

22 ‘‘For the purpose of carrying out parts B, C, and D 

23 (subject to section 851(g)), there are authorized to be ap24 propriated $338,000,000 for fiscal year 2010, and such 


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1 sums as may be necessary for each of the fiscal years 2011 

2 through 2016.’’. 

3 SEC. 443. GRANTS TO PROMOTE THE COMMUNITY HEALTH 

4 WORKFORCE. 

5 (a) IN GENERAL.—Part P of title III of the Public 

6 Health Service Act (42 U.S.C. 280g et seq.), as amended 

7 by subsection (b), is amended by adding at the end the 

8 following: 

9 ‘‘SEC. 399U. GRANTS TO PROMOTE POSITIVE HEALTH BE10 HAVIORS AND OUTCOMES. 

11 ‘‘(a) GRANTS AUTHORIZED.—The Director of the 

12 Centers for Disease Control and Prevention, in collabora13 tion with the Secretary, shall award grants to eligible enti14 ties to promote positive health behaviors and outcomes for 

15 populations in medically underserved communities through 

16 the use of community health workers. 

17 ‘‘(b) USE OF FUNDS.—Grants awarded under sub18 section (a) shall be used to support community health 

19 workers— 

20 ‘‘(1) to educate, guide, and provide outreach in 

21 a community setting regarding health problems prev22 alent in medically underserved communities, particu23 larly racial and ethnic minority populations; 


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1 ‘‘(2) to educate, guide, and provide experiential 

2 learning opportunities that target behavioral risk 

3 factors; 

4 ‘‘(3) to educate and provide guidance regarding 

5 effective strategies to promote positive health behav6 iors within the family; 

7 ‘‘(4) to educate and provide outreach regarding 

8 enrollment in health insurance including the State 

9 Children’s Health Insurance Program under title 

10 XXI of the Social Security Act, Medicare under title 

11 XVIII of such Act and Medicaid under title XIX of 

12 such Act; 

13 ‘‘(5) to educate and refer underserved popu14 lations to appropriate healthcare agencies and com15 munity-based programs and organizations in order 

16 to increase access to quality healthcare services and 

17 to eliminate duplicative care; or 

18 ‘‘(6) to educate, guide, and provide home visita19 tion services regarding maternal health and prenatal 

20 care. 

21 ‘‘(c) APPLICATION.—Each eligible entity that desires 

22 to receive a grant under subsection (a) shall submit an 

23 application to the Secretary, at such time, in such manner, 

24 and accompanied by such information as the Secretary 

25 may require. 


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1 ‘‘(d) PRIORITY.—In awarding grants under sub2 section (a), the Secretary shall give priority to applicants 

3 that— 

4 ‘‘(1) propose to target geographic areas— 

5 ‘‘(A) with a high percentage of residents 

6 who are eligible for health insurance but are 

7 uninsured or underinsured; 

8 ‘‘(B) with a high percentage of residents 

9 who suffer from chronic diseases; or 

10 ‘‘(C) with a high infant mortality rate; 

11 ‘‘(2) have experience in providing health or 

12 health-related social services to individuals who are 

13 underserved with respect to such services; and 

14 ‘‘(3) have documented community activity and 

15 experience with community health workers. 

16 ‘‘(e) COLLABORATION WITH ACADEMIC INSTITU17 TIONS AND THE ONE-STOP DELIVERY SYSTEM.—The Sec18 retary shall encourage community health worker programs 

19 receiving funds under this section to collaborate with aca20 demic institutions and one-stop delivery systems under 

21 section 134(c) of the Workforce Investment Act of 1998. 

22 Nothing in this section shall be construed to require such 

23 collaboration. 

24 ‘‘(f) EVIDENCE-BASED INTERVENTIONS.—The Sec25 retary shall encourage community health worker programs 


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1 receiving funding under this section to implement a proc2 ess or an outcome-based payment system that rewards 

3 community health workers for connecting underserved 

4 populations with the most appropriate services at the most 

5 appropriate time. Nothing in this section shall be con6 strued to require such a payment. 

7 ‘‘(g) QUALITY ASSURANCE AND COST EFFECTIVE8 NESS.—The Secretary shall establish guidelines for assur9 ing the quality of the training and supervision of commu10 nity health workers under the programs funded under this 

11 section and for assuring the cost-effectiveness of such pro12 grams. 

13 ‘‘(h) MONITORING.—The Secretary shall monitor 

14 community health worker programs identified in approved 

15 applications under this section and shall determine wheth16 er such programs are in compliance with the guidelines 

17 established under subsection (g). 

18 ‘‘(i) TECHNICAL ASSISTANCE.—The Secretary may 

19 provide technical assistance to community health worker 

20 programs identified in approved applications under this 

21 section with respect to planning, developing, and operating 

22 programs under the grant. 

23 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated, such sums as may be 


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1 necessary to carry out this section for each of fiscal years 

2 2010 through 2014. 

3 ‘‘(k) DEFINITIONS.—In this section: 

4 ‘‘(1) COMMUNITY HEALTH WORKER.—The term 

5 ‘community health worker’, as defined by the De6 partment of Labor as Standard Occupational Classi7 fication [21–1094] means an individual who pro8 motes health or nutrition within the community in 

9 which the individual resides— 

10 ‘‘(A) by serving as a liaison between com11 munities and healthcare agencies; 

12 ‘‘(B) by providing guidance and social as13 sistance to community residents; 

14 ‘‘(C) by enhancing community residents’ 

15 ability to effectively communicate with 

16 healthcare providers; 

17 ‘‘(D) by providing culturally and linguis18 tically appropriate health or nutrition edu19 cation; 

20 ‘‘(E) by advocating for individual and com21 munity health; and 

22 ‘‘(F) by providing referral and follow-up 

23 services or otherwise coordinating care. 

24 ‘‘(2) COMMUNITY SETTING.—The term ‘commu25 nity setting’ means a home or a community organiVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00703 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 zation located in the neighborhood in which a partic2 ipant in the program under this section resides. 

3 ‘‘(3) ELIGIBLE ENTITY.—The term ‘eligible en4 tity’ means a public or nonprofit private entity (in5 cluding a State or public subdivision of a State, a 

6 public health department, a free health clinic, a hos7 pital, or a Federally-qualified health center (as de8 fined in section 1861(aa) of the Social Security 

9 Act)), or a consortium of any such entities. 

10 ‘‘(4) MEDICALLY UNDERSERVED COMMUNITY.— 

11 The term ‘medically underserved community’ means 

12 a community identified by a State— 

13 ‘‘(A) that has a substantial number of in14 dividuals who are members of a medically un15 derserved population, as defined by section 

16 330(b)(3); and 

17 ‘‘(B) a significant portion of which is a 

18 health professional shortage area as designated 

19 under section 332.’’. 

20 (b) TECHNICAL AMENDMENTS.— 

21 (1) Section 399R of the Public Health Service 

22 Act (as added by section 2 of the ALS Registry Act 

23 (Public Law 110-373; 122 Stat. 4047)) is redesig24 nated as section 399S. 


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1 (2) Section 399R of such Act (as added by sec2 tion 3 of the Prenatally and Postnatally Diagnosed 

3 Conditions Awareness Act (Public Law 110–374; 

4 122 Stat. 4051)) is redesignated as section 399T. 

5 SEC. 444. YOUTH PUBLIC HEALTH PROGRAM. 

6 Section 751(b)(4)(A) of the Public Health Service 

7 Act, as amended by section 453, is further amended by 

8 adding at the end the following: 

9 ‘‘(vii) Establish a youth public health 

10 program to expose and recruit high school 

11 students into health careers, with a focus 

12 on careers in public health.’’. 

13 SEC. 445. FELLOWSHIP TRAINING IN PUBLIC HEALTH. 

14 Part E of title VII of the Public Health Service Act 

15 (42 U.S.C. 294n et seq.), as amended by section 426, is 

16 further amended by adding at the end the following: 

17 ‘‘SEC. 778. FELLOWSHIP TRAINING IN APPLIED PUBLIC 

18 HEALTH EPIDEMIOLOGY, PUBLIC HEALTH 

19 LABORATORY SCIENCE, PUBLIC HEALTH 

20 INFORMATICS, AND EXPANSION OF THE EPI21 DEMIC INTELLIGENCE SERVICE. 

22 ‘‘(a) IN GENERAL.—The Secretary may carry out ac23 tivities to address documented workforce shortages in 

24 State and local health departments in the critical areas 

25 of applied public health epidemiology and public health 


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1 laboratory science and informatics and may expand the 

2 Epidemic Intelligence Service. 

3 ‘‘(b) SPECIFIC USES.—In carrying out subsection 

4 (a), the Secretary shall provide for the expansion of exist5 ing fellowship programs operated through the Centers for 

6 Disease Control and Prevention in a manner that is de7 signed to alleviate shortages of the type described in sub8 section (a). 

9 ‘‘(c) OTHER PROGRAMS.—The Secretary may provide 

10 for the expansion of other applied epidemiology training 

11 programs that meet objectives similar to the objectives of 

12 the programs described in subsection (b). 

13 ‘‘(d) WORK OBLIGATION.—Participation in fellow14 ship training programs under this section shall be deemed 

15 to be service for purposes of satisfying work obligations 

16 stipulated in contracts under section 338I(j). 

17 ‘‘(e) GENERAL SUPPORT.—Amounts may be used 

18 from grants awarded under this section to expand the 

19 Public Health Informatics Fellowship Program at the 

20 Centers for Disease Control and Prevention to better sup21 port all public health systems at all levels of government. 

22 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

23 are authorized to be appropriated to carry out this section 

24 $39,500,000 for each of fiscal years 2010 through 2013, 

25 of which— 


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1 ‘‘(1) $5,000,000 shall be made available in each 

2 such fiscal year for epidemiology fellowship training 

3 program activities under subsections (b) and (c); 

4 ‘‘(2) $5,000,000 shall be made available in each 

5 such fiscal year for laboratory fellowship training 

6 programs under subsection (b); 

7 ‘‘(3) $5,000,000 shall be made available in each 

8 such fiscal year for the Public Health Informatics 

9 Fellowship Program under subsection (e); and 

10 ‘‘(4) $24,500,000 shall be made available for 

11 expanding the Epidemic Intelligence Service under 

12 subsection (a).’’. 

13 SEC. 446. UNITED STATES PUBLIC HEALTH SCIENCES 

14 TRACK. 

15 Title II of the Public Health Service Act (42 U.S.C. 

16 202 et seq.) is amended by adding at the end the fol17 lowing: 

18 ‘‘PART D—UNITED STATES PUBLIC HEALTH 

19 SCIENCES TRACK 

20 ‘‘SEC. 271. ESTABLISHMENT. 

21 ‘‘(a) UNITED STATES PUBLIC HEALTH SERVICES

22 TRACK.— 

23 ‘‘(1) IN GENERAL.—There is hereby authorized 

24 to be established a United States Public Health 

25 Sciences Track (referred to in this part as the 


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1 ‘Track’), at sites to be selected by the Secretary, 

2 with authority to grant appropriate advanced de3 grees in a manner that uniquely emphasizes team4 based service, public health, epidemiology, and emer5 gency preparedness and response. It shall be so or6 ganized as to graduate not less than— 

7 ‘‘(A) 150 medical students annually, 10 of 

8 whom shall be awarded studentships to the Uni9 formed Services University of Health Sciences; 

10 ‘‘(B) 100 dental students annually; 

11 ‘‘(C) 250 nursing students annually; 

12 ‘‘(D) 100 public health students annually; 

13 ‘‘(E) 100 behavioral and mental health 

14 professional students annually; 

15 ‘‘(F) 100 physician assistant or nurse 

16 practitioner students annually; and 

17 ‘‘(G) 50 pharmacy students annually. 

18 ‘‘(2) LOCATIONS.—The Track shall be located 

19 at existing and accredited, affiliated health profes20 sions education training programs at academic 

21 health centers located in regions of the United 

22 States determined appropriate by the Surgeon Gen23 eral, in consultation with the National Health Care 

24 Workforce Commission. 


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1 ‘‘(b) NUMBER OF GRADUATES.—Except as provided 

2 in subsection (a), the number of persons to be graduated 

3 from the Track shall be prescribed by the Secretary. In 

4 so prescribing the number of persons to be graduated from 

5 the Track, the Secretary shall institute actions necessary 

6 to ensure the maximum number of first-year enrollments 

7 in the Track consistent with the academic capacity of the 

8 affiliated sites and the needs of the United States for med9 ical, dental, and nursing personnel. 

10 ‘‘(c) DEVELOPMENT.—The development of the Track 

11 may be by such phases as the Secretary may prescribe 

12 subject to the requirements of subsection (a). 

13 ‘‘(d) INTEGRATED LONGITUDINAL PLAN.—The Sur14 geon General shall develop an integrated longitudinal plan 

15 for health professions continuing education throughout the 

16 continuum of health-related education, training, and prac17 tice. Training under such plan shall emphasize patient18 centered, interdisciplinary, and care coordination skills. 

19 Experience with deployment of emergency response teams 

20 shall be included during the clinical experiences. 

21 ‘‘(e) FACULTY DEVELOPMENT.—The Surgeon Gen22 eral shall develop faculty development programs and cur23 ricula in decentralized venues of health care, to balance 

24 urban, tertiary, and inpatient venues. 


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1 ‘‘SEC. 272. ADMINISTRATION. 

2 ‘‘(a) IN GENERAL.—The business of the Track shall 

3 be conducted by the Surgeon General with funds appro4 priated for and provided by the Department of Health and 

5 Human Services. The National Health Workforce Com6 mission shall assist the Surgeon General in an advisory 

7 capacity. 

8 ‘‘(b) FACULTY.— 

9 ‘‘(1) IN GENERAL.—The Surgeon General, after 

10 considering the recommendations of the National 

11 Health Workforce Commission, shall obtain the serv12 ices of such professors, instructors, and administra13 tive and other employees as may be necessary to op14 erate the Track, but utilize when possible, existing 

15 affiliated health professions training institutions. 

16 Members of the faculty and staff shall be employed 

17 under salary schedules and granted retirement and 

18 other related benefits prescribed by the Secretary so 

19 as to place the employees of the Track faculty on a 

20 comparable basis with the employees of fully accred21 ited schools of the health professions within the 

22 United States. 

23 ‘‘(2) TITLES.—The Surgeon General may con24 fer academic titles, as appropriate, upon the mem25 bers of the faculty. 


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1 ‘‘(3) NONAPPLICATION OF PROVISIONS.—The 

2 limitations in section 5373 of title 5, United States 

3 Code, shall not apply to the authority of the Surgeon 

4 General under paragraph (1) to prescribe salary 

5 schedules and other related benefits. 

6 ‘‘(c) AGREEMENTS.—The Surgeon General may ne7 gotiate agreements with agencies of the Federal Govern8 ment to utilize on a reimbursable basis appropriate exist9 ing Federal medical resources located in the United States 

10 (or locations selected in accordance with section 

11 271(a)(2)). Under such agreements the facilities con12 cerned will retain their identities and basic missions. The 

13 Surgeon General may negotiate affiliation agreements 

14 with accredited universities and health professions train15 ing institutions in the United States. Such agreements 

16 may include provisions for payments for educational serv17 ices provided students participating in Department of 

18 Health and Human Services educational programs. 

19 ‘‘(d) PROGRAMS.—The Surgeon General may estab20 lish the following educational programs for Track stu21 dents: 

22 ‘‘(1) Postdoctoral, postgraduate, and techno23 logical programs. 


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1 ‘‘(2) A cooperative program for medical, dental, 

2 physician assistant, pharmacy, behavioral and men3 tal health, public health, and nursing students. 

4 ‘‘(3) Other programs that the Surgeon General 

5 determines necessary in order to operate the Track 

6 in a cost-effective manner. 

7 ‘‘(e) CONTINUING MEDICAL EDUCATION.—The Sur8 geon General shall establish programs in continuing med9 ical education for members of the health professions to 

10 the end that high standards of health care may be main11 tained within the United States. 

12 ‘‘(f) AUTHORITY OF THE SURGEON GENERAL.— 

13 ‘‘(1) IN GENERAL.—The Surgeon General is au14 thorized— 

15 ‘‘(A) to enter into contracts with, accept 

16 grants from, and make grants to any nonprofit 

17 entity for the purpose of carrying out coopera18 tive enterprises in medical, dental, physician as19 sistant, pharmacy, behavioral and mental 

20 health, public health, and nursing research, 

21 consultation, and education; 

22 ‘‘(B) to enter into contracts with entities 

23 under which the Surgeon General may furnish 

24 the services of such professional, technical, or 

25 clerical personnel as may be necessary to fulfill 


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1 cooperative enterprises undertaken by the 

2 Track; 

3 ‘‘(C) to accept, hold, administer, invest, 

4 and spend any gift, devise, or bequest of per5 sonal property made to the Track, including 

6 any gift, devise, or bequest for the support of 

7 an academic chair, teaching, research, or dem8 onstration project; 

9 ‘‘(D) to enter into agreements with entities 

10 that may be utilized by the Track for the pur11 pose of enhancing the activities of the Track in 

12 education, research, and technological applica13 tions of knowledge; and 

14 ‘‘(E) to accept the voluntary services of 

15 guest scholars and other persons. 

16 ‘‘(2) LIMITATION.—The Surgeon General may 

17 not enter into any contract with an entity if the con18 tract would obligate the Track to make outlays in 

19 advance of the enactment of budget authority for 

20 such outlays. 

21 ‘‘(3) SCIENTISTS.—Scientists or other medical, 

22 dental, or nursing personnel utilized by the Track 

23 under an agreement described in paragraph (1) may 

24 be appointed to any position within the Track and 


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1 may be permitted to perform such duties within the 

2 Track as the Surgeon General may approve. 

3 ‘‘(4) VOLUNTEER SERVICES.—A person who 

4 provides voluntary services under the authority of 

5 subparagraph (E) of paragraph (1) shall be consid6 ered to be an employee of the Federal Government 

7 for the purposes of chapter 81 of title 5, relating to 

8 compensation for work-related injuries, and to be an 

9 employee of the Federal Government for the pur10 poses of chapter 171 of title 28, relating to tort 

11 claims. Such a person who is not otherwise employed 

12 by the Federal Government shall not be considered 

13 to be a Federal employee for any other purpose by 

14 reason of the provision of such services. 

15 ‘‘SEC. 273. STUDENTS; SELECTION; OBLIGATION. 

16 ‘‘(a) STUDENT SELECTION.— 

17 ‘‘(1) IN GENERAL.—Medical, dental, physician 

18 assistant, pharmacy, behavioral and mental health, 

19 public health, and nursing students at the Track 

20 shall be selected under procedures prescribed by the 

21 Surgeon General. In so prescribing, the Surgeon 

22 General shall consider the recommendations of the 

23 National Health Workforce Commission. 

24 ‘‘(2) PRIORITY.—In developing admissions pro25 cedures under paragraph (1), the Surgeon General 


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1 shall ensure that such procedures give priority to ap2 plicant medical, dental, physician assistant, phar3 macy, behavioral and mental health, public health, 

4 and nursing students from rural communities and 

5 underrepresented minorities. 

6 ‘‘(b) CONTRACT AND SERVICE OBLIGATION.— 

7 ‘‘(1) CONTRACT.—Upon being admitted to the 

8 Track, a medical, dental, physician assistant, phar9 macy, behavioral and mental health, public health, 

10 or nursing student shall enter into a written con11 tract with the Surgeon General that shall contain— 

12 ‘‘(A) an agreement under which— 

13 ‘‘(i) subject to subparagraph (B), the 

14 Surgeon General agrees to provide the stu15 dent with tuition (or tuition remission) and 

16 a student stipend (described in paragraph 

17 (2)) in each school year for a period of 

18 years (not to exceed 4 school years) deter19 mined by the student, during which period 

20 the student is enrolled in the Track at an 

21 affiliated or other participating health pro22 fessions institution pursuant to an agree23 ment between the Track and such institu24 tion; and 


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1 ‘‘(ii) subject to subparagraph (B), the 

2 student agrees— 

3 ‘‘(I) to accept the provision of 

4 such tuition and student stipend to 

5 the student; 

6 ‘‘(II) to maintain enrollment at 

7 the Track until the student completes 

8 the course of study involved; 

9 ‘‘(III) while enrolled in such 

10 course of study, to maintain an ac11 ceptable level of academic standing 

12 (as determined by the Surgeon Gen13 eral); 

14 ‘‘(IV) if pursuing a degree from 

15 a school of medicine or osteopathic 

16 medicine, dental, public health, or 

17 nursing school or a physician assist18 ant, pharmacy, or behavioral and 

19 mental health professional program, 

20 to complete a residency or internship 

21 in a specialty that the Surgeon Gen22 eral determines is appropriate; and 

23 ‘‘(V) to serve for a period of time 

24 (referred to in this part as the ‘period 

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1 missioned Corps of the Public Health 

2 Service equal to 2 years for each 

3 school year during which such indi4 vidual was enrolled at the College, re5 duced as provided for in paragraph 

6 (3); 

7 ‘‘(B) a provision that any financial obliga8 tion of the United States arising out of a con9 tract entered into under this part and any obli10 gation of the student which is conditioned 

11 thereon, is contingent upon funds being appro12 priated to carry out this part; 

13 ‘‘(C) a statement of the damages to which 

14 the United States is entitled for the student’s 

15 breach of the contract; and 

16 ‘‘(D) such other statements of the rights 

17 and liabilities of the Secretary and of the indi18 vidual, not inconsistent with the provisions of 

19 this part. 

20 ‘‘(2) TUITION AND STUDENT STIPEND.— 

21 ‘‘(A) TUITION REMISSION RATES.—The 

22 Surgeon General, based on the recommenda23 tions of the National Health Workforce Com24 mission established under section 411 of the Af25 fordable Health Choices Act, shall establish 


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1 Federal tuition remission rates to be used by 

2 the Track to provide reimbursement to affili3 ated and other participating health professions 

4 institutions for the cost of educational services 

5 provided by such institutions to Track students. 

6 The agreement entered into by such partici7 pating institutions under paragraph (1)(A)(i) 

8 shall contain an agreement to accept as pay9 ment in full the established remission rate 

10 under this subparagraph. 

11 ‘‘(B) STIPEND.—The Surgeon General, 

12 based on the recommendations of the National 

13 Health Workforce Commission, shall establish 

14 and update Federal stipend rates for payment 

15 to students under this part. 

16 ‘‘(3) REDUCTIONS IN THE PERIOD OF OBLI17 GATED SERVICE.—The period of obligated service 

18 under paragraph (1)(A)(ii)(V) shall be reduced— 

19 ‘‘(A) in the case of a student who elects to 

20 participate in a high-needs speciality residency 

21 (as determined by the National Health Work22 force Commission), by 3 months for each year 

23 of such participation (not to exceed a total of 

24 12 months); and 


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1 ‘‘(B) in the case of a student who, upon 

2 completion of their residency, elects to practice 

3 in a Federal medical facility (as defined in sec4 tion 781(e)) that is located in a health profes5 sional shortage area (as defined in section 332), 

6 by 3 months for year of full-time practice in 

7 such a facility (not to exceed a total of 12 

8 months). 

9 ‘‘(c) SECOND 2 YEARS OF SERVICE.—During the 

10 third and fourth years in which a medical, dental, physi11 cian assistant, pharmacy, behavioral and mental health, 

12 public health, or nursing student is enrolled in the Track, 

13 training should be designed to prioritize clinical rotations 

14 in Federal medical facilities in health professional short15 age areas, and emphasize a balance of hospital and com16 munity-based experiences, and training within inter17 disciplinary teams. 

18 ‘‘(d) DENTIST, PHYSICIAN ASSISTANT, PHARMACIST, 

19 BEHAVIORAL AND MENTAL HEALTH PROFESSIONAL, 

20 PUBLIC HEALTH PROFESSIONAL, AND NURSE TRAIN21 ING.—The Surgeon General shall establish provisions ap22 plicable with respect to dental, physician assistant, phar23 macy, behavioral and mental health, public health, and 

24 nursing students that are comparable to those for medical 

25 students under this section, including service obligations, 


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1 tuition support, and stipend support. The Surgeon Gen2 eral shall give priority to health professions training insti3 tutions that train medical, dental, physician assistant, 

4 pharmacy, behavioral and mental health, public health, 

5 and nursing students for some significant period of time 

6 together, but at a minimum have a discrete and shared 

7 core curriculum. 

8 ‘‘(e) ELITE FEDERAL DISASTER TEAMS.—The Sur9 geon General, in consultation with the Secretary, the Di10 rector of the Centers for Disease Control and Prevention, 

11 and other appropriate military and Federal government 

12 agencies, shall develop criteria for the appointment of 

13 highly qualified Track faculty, medical, dental, physician 

14 assistant, pharmacy, behavioral and mental health, public 

15 health, and nursing students, and graduates to elite Fed16 eral disaster preparedness teams to train and to respond 

17 to public health emergencies, natural disasters, bioter18 rorism events, and other emergencies. 

19 ‘‘(f) STUDENT DROPPED FROM TRACK IN AFFILIATE

20 SCHOOL.—A medical, dental, physician assistant, phar21 macy, behavioral and mental health, public health, or 

22 nursing student who, under regulations prescribed by the 

23 Surgeon General, is dropped from the Track in an affili24 ated school for deficiency in conduct or studies, or for 


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1 other reasons, shall be liable to the United States for all 

2 tuition and stipend support provided to the student. 

3 ‘‘SEC. 274. FUNDING. 

4 ‘‘Beginning with fiscal year 2010, the Secretary shall 

5 transfer from the Public Health and Social Services Emer6 gency Fund such sums as may be necessary to carry out 

7 this part.’’. 

8 Subtitle E—Supporting the 

9 Existing Health Care Workforce 

10 SEC. 451. CENTERS OF EXCELLENCE. 

11 Section 736 of the Public Health Service Act (42 

12 U.S.C. 293) is amended by striking subsection (h) and in13 serting the following: 

14 ‘‘(h) FORMULA FOR ALLOCATIONS.— 

15 ‘‘(1) ALLOCATIONS.—Based on the amount ap16 propriated under subsection (i) for a fiscal year, the 

17 following subparagraphs shall apply as appropriate: 

18 ‘‘(A) IN GENERAL.—If the amounts appro19 priated under subsection (i) for a fiscal year are 

20 $24,000,000 or less— 

21 ‘‘(i) the Secretary shall make available 

22 $12,000,000 for grants under subsection 

23 (a) to health professions schools that meet 

24 the conditions described in subsection 

25 (c)(2)(A); and 


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1 ‘‘(ii) and available after grants are 

2 made with funds under clause (i), the Sec3 retary shall make available— 

4 ‘‘(I) 60 percent of such amount 

5 for grants under subsection (a) to 

6 health professions schools that meet 

7 the conditions described in paragraph 

8 (3) or (4) of subsection (c) (including 

9 meeting the conditions under sub10 section (e)); and 

11 ‘‘(II) 40 percent of such amount 

12 for grants under subsection (a) to 

13 health professions schools that meet 

14 the conditions described in subsection 

15 (c)(5). 

16 ‘‘(B) FUNDING IN EXCESS OF

17 $24,000,000.—If amounts appropriated under 

18 subsection (i) for a fiscal year exceed 

19 $24,000,000 but are less than $30,000,000— 

20 ‘‘(i) 80 percent of such excess 

21 amounts shall be made available for grants 

22 under subsection (a) to health professions 

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1 section (c) (including meeting conditions 

2 pursuant to subsection (e)); and 

3 ‘‘(ii) 20 percent of such excess 

4 amount shall be made available for grants 

5 under subsection (a) to health professions 

6 schools that meet the conditions described 

7 in subsection (c)(5). 

8 ‘‘(C) FUNDING IN EXCESS OF

9 $30,000,000.—If amounts appropriated under 

10 subsection (i) for a fiscal year exceed 

11 $30,000,000 but are less than $40,000,000, the 

12 Secretary shall make available— 

13 ‘‘(i) not less than $12,000,000 for 

14 grants under subsection (a) to health pro15 fessions schools that meet the conditions 

16 described in subsection (c)(2)(A); 

17 ‘‘(ii) not less than $12,000,000 for 

18 grants under subsection (a) to health pro19 fessions schools that meet the conditions 

20 described in paragraph (3) or (4) of sub21 section (c) (including meeting conditions 

22 pursuant to subsection (e)); 

23 ‘‘(iii) not less than $6,000,000 for 

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1 fessions schools that meet the conditions 

2 described in subsection (c)(5); and 

3 ‘‘(iv) after grants are made with 

4 funds under clauses (i) through (iii), any 

5 remaining excess amount for grants under 

6 subsection (a) to health professions schools 

7 that meet the conditions described in para8 graph (2)(A), (3), (4), or (5) of subsection 

9 (c). 

10 ‘‘(D) FUNDING IN EXCESS OF

11 $40,000,000.—If amounts appropriated under 

12 subsection (i) for a fiscal year are $40,000,000 

13 or more, the Secretary shall make available— 

14 ‘‘(i) not less than $16,000,000 for 

15 grants under subsection (a) to health pro16 fessions schools that meet the conditions 

17 described in subsection (c)(2)(A); 

18 ‘‘(ii) not less than $16,000,000 for 

19 grants under subsection (a) to health pro20 fessions schools that meet the conditions 

21 described in paragraph (3) or (4) of sub22 section (c) (including meeting conditions 

23 pursuant to subsection (e)); 

24 ‘‘(iii) not less than $8,000,000 for 

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1 fessions schools that meet the conditions 

2 described in subsection (c)(5); and 

3 ‘‘(iv) after grants are made with 

4 funds under clauses (i) through (iii), any 

5 remaining funds for grants under sub6 section (a) to health professions schools 

7 that meet the conditions described in para8 graph (2)(A), (3), (4), or (5) of subsection 

9 (c). 

10 ‘‘(2) NO LIMITATION.—Nothing in this sub11 section shall be construed as limiting the centers of 

12 excellence referred to in this section to the des13 ignated amount, or to preclude such entities from 

14 competing for grants under this section. 

15 ‘‘(3) MAINTENANCE OF EFFORT.— 

16 ‘‘(A) IN GENERAL.—With respect to activi17 ties for which a grant made under this part are 

18 authorized to be expended, the Secretary may 

19 not make such a grant to a center of excellence 

20 for any fiscal year unless the center agrees to 

21 maintain expenditures of non-Federal amounts 

22 for such activities at a level that is not less 

23 than the level of such expenditures maintained 

24 by the center for the fiscal year preceding the 


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1 fiscal year for which the school receives such a 

2 grant. 

3 ‘‘(B) USE OF FEDERAL FUNDS.—With re4 spect to any Federal amounts received by a cen5 ter of excellence and available for carrying out 

6 activities for which a grant under this part is 

7 authorized to be expended, the center shall, be8 fore expending the grant, expend the Federal 

9 amounts obtained from sources other than the 

10 grant, unless given prior approval from the Sec11 retary. 

12 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this sec14 tion— 

15 ‘‘(1) $50,000,000 for each of the fiscal years 

16 2010 through 2015; and 

17 ‘‘(2) and such sums as are necessary for each 

18 subsequent fiscal year.’’. 

19 SEC. 452. HEALTH CARE PROFESSIONALS TRAINING FOR 

20 DIVERSITY. 

21 (a) LOAN REPAYMENTS AND FELLOWSHIPS REGARD22 ING FACULTY POSITIONS.—Section 738(a)(1) of the Pub23 lic Health Service Act (42 U.S.C. 293b(a)(1)) is amended 

24 by striking ‘‘$20,000 of the principal and interest of the 

25 educational loans of such individuals.’’ and inserting 


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1 ‘‘$30,000 of the principal and interest of the educational 

2 loans of such individuals.’’. 

3 (b) SCHOLARSHIPS FOR DISADVANTAGED STU4 DENTS.—Section 740(a) of such Act (42 U.S.C. 293d(a)) 

5 is amended by striking ‘‘$37,000,000’’ and all that follows 

6 through ‘‘2002’’ and inserting ‘‘$51,000,000 for fiscal 

7 year 2010, and such sums as may be necessary for each 

8 of the fiscal years 2011 through 2014’’. 

9 (c) REAUTHORIZATION FOR LOAN REPAYMENTS AND

10 FELLOWSHIPS REGARDING FACULTY POSITIONS.—Sec11 tion 740(b) of such Act (42 U.S.C. 293d(b)) is amended 

12 by striking ‘‘appropriated’’ and all that follows through 

13 the period at the end and inserting ‘‘appropriated, 

14 $5,000,000 for each of the fiscal years 2010 through 

15 2014.’’. 

16 (d) REAUTHORIZATION FOR EDUCATIONAL ASSIST17 ANCE IN THE HEALTH PROFESSIONS REGARDING INDI18 VIDUALS FROM A DISADVANTAGED BACKGROUND.—Sec19 tion 740(c) of such Act (42 U.S.C. 293d(c)) is amended 

20 by striking the first sentence and inserting the following: 

21 ‘‘For the purpose of grants and contracts under section 

22 739(a)(1), there is authorized to be appropriated 

23 $60,000,000 for fiscal year 2010 and such sums as may 

24 be necessary for each of the fiscal years 2011 through 

25 2014.’’ 


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1 SEC. 453. INTERDISCIPLINARY, COMMUNITY-BASED LINK2 AGES. 

3 (a) AREA HEALTH EDUCATION CENTERS.—Section 

4 751 of the Public Health Service Act (42 U.S.C. 294a) 

5 is amended to read as follows: 

6 ‘‘SEC. 751. AREA HEALTH EDUCATION CENTERS. 

7 ‘‘(a) ESTABLISHMENT OF AWARDS.—The Secretary 

8 shall make awards in accordance with this section. 

9 ‘‘(b) INFRASTRUCTURE DEVELOPMENT AWARD.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall make 

11 awards to eligible entities to enable such entities to 

12 initiate health care workforce educational programs 

13 or to continue to carry out comparable programs 

14 that are operating at the time the award is made by 

15 planning, developing, operating, and evaluating of an 

16 area health education center program. 

17 ‘‘(2) ELIGIBLE ENTITY.—For purposes of this 

18 subsection, an ‘eligible entity’ means a school of 

19 medicine or osteopathic medicine, an incorporated 

20 consortium of such schools, or the parent institu21 tions of such a school. With respect to a State in 

22 which no area health education center program is in 

23 operation, the Secretary may award a grant or con24 tract under paragraph (1) to a school of nursing. 

25 ‘‘(3) APPLICATION.—An eligible entity desiring 

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1 mit to the Secretary an application at such time, in 

2 such manner, and containing such information as 

3 the Secretary may require. 

4 ‘‘(4) USE OF FUNDS.— 

5 ‘‘(A) REQUIRED ACTIVITIES.—An eligible 

6 entity shall use amounts awarded under a grant 

7 under paragraph (1) to carry out the following 

8 activities: 

9 ‘‘(i) Develop and implement strate10 gies, in coordination with the applicable 

11 one-stop delivery system under section 

12 134(c) of the Workforce Investment Act of 

13 1998, to recruit individuals from underrep14 resented minority populations or from dis15 advantaged or rural backgrounds into 

16 health professions, and support such indi17 viduals in attaining such careers. 

18 ‘‘(ii) Develop and implement strate19 gies to foster and provide community-based 

20 training and education to individuals seek21 ing careers in health professions within un22 derserved areas for the purpose of devel23 oping and maintaining a diverse health 

24 care workforce that is prepared to deliver 

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1 mary care, in underserved areas or for 

2 health disparity populations, in collabora3 tion with other Federal and State health 

4 care workforce development programs, the 

5 State workforce agency, and local work6 force investment boards, and in health care 

7 safety net sites. 

8 ‘‘(iii) Prepare individuals to more ef9 fectively provide health services to under10 served areas and health disparity popu11 lations through field placements or precep12 torships in conjunction with community13 based organizations, accredited primary 

14 care residency training programs, Feder15 ally qualified health centers, rural health 

16 clinics, public health departments, or other 

17 appropriate facilities. 

18 ‘‘(iv) Conduct and participate in inter19 disciplinary training that involves physi20 cians, physician assistants, nurse practi21 tioners, nurse midwives, dentists, psycholo22 gists, pharmacists, optometrists, commu23 nity health workers, public and allied 

24 health professionals, or other health pro25 fessionals, as practicable. 


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1 ‘‘(v) Deliver or facilitate continuing 

2 education and information dissemination 

3 programs for health care professionals, 

4 with an emphasis on individuals providing 

5 care in underserved areas and for health 

6 disparity populations. 

7 ‘‘(vi) Propose and implement effective 

8 program and outcomes measurement and 

9 evaluation strategies. 

10 ‘‘(B) INNOVATIVE OPPORTUNITIES.—An 

11 eligible entity may use amounts awarded under 

12 a grant under paragraph (1) to carry out any 

13 of the following activities: 

14 ‘‘(i) Develop and implement innovative 

15 curricula in collaboration with community16 based accredited primary care residency 

17 training programs, Federally qualified 

18 health centers, rural health clinics, behav19 ioral and mental health facilities, public 

20 health departments, or other appropriate 

21 facilities, with the goal of increasing the 

22 number of primary care physicians and 

23 other primary care providers prepared to 

24 serve in underserved areas and health dis25 parity populations. 


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1 ‘‘(ii) Coordinate community-based 

2 participatory research with academic 

3 health centers, and facilitate rapid flow 

4 and dissemination of evidence-based health 

5 care information, research results, and best 

6 practices to improve quality, efficiency, and 

7 effectiveness of health care and health care 

8 systems within community settings. 

9 ‘‘(iii) Develop and implement other 

10 strategies to address identified workforce 

11 needs and increase and enhance the health 

12 care workforce in the area served by the 

13 area health education center program. 

14 ‘‘(c) POINT OF SERVICE MAINTENANCE AND EN15 HANCEMENT AWARD.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall make 

17 awards to eligible entities to maintain and improve 

18 the effectiveness and capabilities of an existing area 

19 health education center program, and make other 

20 modifications to the program that are appropriate 

21 due to changes in demographics, needs of the popu22 lations served, or other similar issues affecting the 

23 program. 

24 ‘‘(2) ELIGIBLE ENTITY.—For purposes of this 

25 subsection, the term ‘eligible entity’ means an entity 


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1 that has received funds under this section (as this 

2 section was in effect on the day before the date of 

3 enactment of the Affordable Health Choices Act), is 

4 operating an area health education center program, 

5 including area health education centers, and has a 

6 center or centers that are no longer eligible to re7 ceive financial assistance under subsection (b). 

8 ‘‘(3) APPLICATION.—An eligible entity desiring 

9 to receive an award under this subsection shall sub10 mit to the Secretary an application at such time, in 

11 such manner, and containing such information as 

12 the Secretary may require. 

13 ‘‘(4) USE OF FUNDS.— 

14 ‘‘(A) REQUIRED ACTIVITIES.—An eligible 

15 entity shall use amounts awarded under a grant 

16 under paragraph (1) to carry out the following 

17 activities: 

18 ‘‘(i) Develop and implement strategies 

19 in coordination with the applicable one20 stop delivery system under section 134(c) 

21 of the Workforce Investment Act of 1998 

22 to recruit individuals from underrep23 resented minority groups, underserved 

24 areas, or with rural backgrounds into 


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1 health care careers, and support such indi2 viduals in attaining such careers. 

3 ‘‘(ii) Develop and implement strate4 gies to foster and provide community-based 

5 training and education to individuals seek6 ing careers in health professions within un7 derserved areas for the purpose of devel8 oping and maintaining a diverse health 

9 care workforce that is prepared to deliver 

10 high-quality care, with an emphasis on pri11 mary care, in underserved areas and to 

12 health disparity populations, in collabora13 tion with other Federal and State health 

14 care workforce development programs, and 

15 in health care safety net sites. 

16 ‘‘(iii) Prepare individuals to more ef17 fectively provide health services to under18 served areas or health disparity popu19 lations through field placements or precep20 torships in conjunction with community21 based organizations, accredited primary 

22 care residency training programs, Feder23 ally qualified health centers, rural health 

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1 ties, public health departments, or other 

2 appropriate facilities. 

3 ‘‘(iv) Conduct and participate in inter4 disciplinary training that involves physi5 cians, physician assistants, nurse practi6 tioners, nurse midwives, dentists, psycholo7 gists, pharmacists, optometrists, commu8 nity health workers, public and allied 

9 health professionals, or other health pro10 fessionals, as practicable. 

11 ‘‘(v) Deliver or facilitate continuing 

12 education and information dissemination 

13 programs for health care professionals, 

14 with an emphasis on individuals providing 

15 care in underserved areas and for health 

16 disparity populations. 

17 ‘‘(vi) Propose and implement effective 

18 program and outcomes measurement and 

19 evaluation strategies. 

20 ‘‘(B) INNOVATIVE OPPORTUNITIES.—An 

21 eligible entity shall use amounts awarded under 

22 a grant under paragraph (1) to carry out at 

23 least 1 of the following activities: 

24 ‘‘(i) Develop innovative curricula in 

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1 credited primary care residency training 

2 programs, Federally qualified health cen3 ters, rural health clinics, behavioral and 

4 mental health facilities, public health de5 partments, or other appropriate facilities, 

6 with the goal of increasing the number of 

7 primary care physicians and other primary 

8 care providers prepared to serve in under9 served areas and health disparity popu10 lations. 

11 ‘‘(ii) Coordinate community-based 

12 participatory research with academic 

13 health centers, and facilitate rapid flow 

14 and dissemination of evidence-based health 

15 care information, research results, and best 

16 practices to improve quality, efficiency, and 

17 effectiveness of health care and health care 

18 systems within community settings. 

19 ‘‘(iii) Develop and implement other 

20 strategies to address identified workforce 

21 needs and increase and enhance the health 

22 care workforce in the area served by the 

23 area health education center program. 

24 ‘‘(d) REQUIREMENTS.— 


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1 ‘‘(1) AREA HEALTH EDUCATION CENTER PRO2 GRAM.—In carrying out this section, the Secretary 

3 shall ensure the following: 

4 ‘‘(A) An entity that receives an award 

5 under this section shall conduct at least 10 per6 cent of clinical education required for medical 

7 students in community settings that are re8 moved from the primary teaching facility of the 

9 contracting institution for grantees that operate 

10 a school of medicine or osteopathic medicine. In 

11 States in which an entity that receives an 

12 award under this section is a nursing school or 

13 its parent institution, the Secretary shall alter14 natively ensure that— 

15 ‘‘(i) the nursing school places at least 

16 10 percent of its students in training sites 

17 affiliated with an area health education 

18 center that is remote from the primary 

19 teaching facility of the school; and 

20 ‘‘(ii) the entity receiving the award 

21 maintains a written agreement with a 

22 school of medicine or osteopathic medicine 

23 to place at least 10 percent of students 

24 from that school in training sites in the 

25 area health education center program area. 


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1 ‘‘(B) An entity receiving funds under sub2 section (c) does not distribute such funding to 

3 a center that is eligible to receive funding under 

4 subsection (b). 

5 ‘‘(2) AREA HEALTH EDUCATION CENTER.—The 

6 Secretary shall ensure that each area health edu7 cation center program includes at least 1 area health 

8 education center, and that each such center— 

9 ‘‘(A) is a public or private organization 

10 whose structure, governance, and operation is 

11 independent from the awardee and the parent 

12 institution of the awardee; 

13 ‘‘(B) is not a school of medicine or osteo14 pathic medicine, the parent institution of such 

15 a school, or a branch campus or other subunit 

16 of a school of medicine or osteopathic medicine 

17 or its parent institution, or a consortium of 

18 such entities; 

19 ‘‘(C) designates an underserved area or 

20 population to be served by the center which is 

21 in a location removed from the main location of 

22 the teaching facilities of the schools partici23 pating in the program with such center and 

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1 graphic area or population served by any other 

2 center; 

3 ‘‘(D) fosters networking and collaboration 

4 among communities and between academic 

5 health centers and community-based centers; 

6 ‘‘(E) serves communities with a dem7 onstrated need of health professionals in part8 nership with academic medical centers; 

9 ‘‘(F) addresses the health care workforce 

10 needs of the communities served in coordination 

11 with the public workforce investment system; 

12 and 

13 ‘‘(G) has a community-based governing or 

14 advisory board that reflects the diversity of the 

15 communities involved. 

16 ‘‘(e) MATCHING FUNDS.—With respect to the costs 

17 of operating a program through a grant under this section, 

18 to be eligible for financial assistance under this section, 

19 an entity shall make available (directly or through con20 tributions from State, county or municipal governments, 

21 or the private sector) recurring non-Federal contributions 

22 in cash or in kind, toward such costs in an amount that 

23 is equal to not less than 50 percent of such costs. At least 

24 25 percent of the total required non-Federal contributions 

25 shall be in cash. An entity may apply to the Secretary 


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1 for a waiver of not more than 75 percent of the matching 

2 fund amount required by the entity for each of the first 

3 3 years the entity is funded through a grant under sub4 section (b). 

5 ‘‘(f) LIMITATION.—Not less than 75 percent of the 

6 total amount provided to an area health education center 

7 program under subsection (b) or (c) shall be allocated to 

8 the area health education centers participating in the pro9 gram under this section. To provide needed flexibility to 

10 newly funded area health education center programs, the 

11 Secretary may waive the requirement in the sentence for 

12 the first 2 years of a new area health education center 

13 program funded under subsection (b). 

14 ‘‘(g) AWARD.—An award to an entity under this sec15 tion shall be not less than $250,000 annually per area 

16 health education center included in the program involved. 

17 If amounts appropriated to carry out this section are not 

18 sufficient to comply with the preceding sentence, the Sec19 retary may reduce the per center amount provided for in 

20 such sentence as necessary, provided the distribution es21 tablished in subsection (k)(2) is maintained. 

22 ‘‘(h) PROJECT TERMS.— 

23 ‘‘(1) IN GENERAL.—Except as provided in para24 graph (2), the period during which payments may be 


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1 made under an award under subsection (b) may not 

2 exceed— 

3 ‘‘(A) in the case of a program, 12 years; 

4 or 

5 ‘‘(B) in the case of a center within a pro6 gram, 6 years. 

7 ‘‘(2) EXCEPTION.—The periods described in 

8 paragraph (1) shall not apply to programs receiving 

9 point of service maintenance and enhancement 

10 awards under subsection (c) to maintain existing 

11 centers and activities. 

12 ‘‘(i) INAPPLICABILITY OF PROVISION.—Notwith13 standing any other provision of this title, section 791(a) 

14 shall not apply to an area health education center funded 

15 under this section. 

16 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.— 

17 ‘‘(1) IN GENERAL.—There is authorized to be 

18 appropriated to carry out this section $125,000,000 

19 for each of the fiscal years 2010 through 2014. 

20 ‘‘(2) REQUIREMENTS.—Of the amounts appro21 priated for a fiscal year under paragraph (1)— 

22 ‘‘(A) not more than 35 percent shall be 

23 used for awards under subsection (b); 

24 ‘‘(B) not less than 60 percent shall be used 

25 for awards under subsection (c); 


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1 ‘‘(C) not more than 1 percent shall be used 

2 for grants and contracts to implement outcomes 

3 evaluation for the area health education cen4 ters; and 

5 ‘‘(D) not more than 4 percent shall be 

6 used for grants and contracts to provide tech7 nical assistance to entities receiving awards 

8 under this section. 

9 ‘‘(3) CARRYOVER FUNDS.—An entity that re10 ceives an award under this section may carry over 

11 funds from 1 fiscal year to another without obtain12 ing approval from the Secretary. In no case may any 

13 funds be carried over pursuant to the preceding sen14 tence for more than 3 years. 

15 ‘‘(k) SENSE OF CONGRESS.—It is the sense of the 

16 Congress that every State have an area health education 

17 center program in effect under this section.’’. 

18 (b) CONTINUING EDUCATIONAL SUPPORT FOR

19 HEALTH PROFESSIONALS SERVING IN UNDERSERVED

20 COMMUNITIES.—Part D of title VII of the Public Health 

21 Service Act (42 U.S.C. 294 et seq.) is amended by striking 

22 section 752 and inserting the following: 


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1 ‘‘SEC. 752. CONTINUING EDUCATIONAL SUPPORT FOR 

2 HEALTH PROFESSIONALS SERVING IN UN3 DERSERVED COMMUNITIES. 

4 ‘‘(a) IN GENERAL.—The Secretary shall make grants 

5 to, and enter into contracts with, eligible entities to im6 prove health care, increase retention, increase representa7 tion of minority faculty members, enhance the practice en8 vironment, and provide information dissemination and 

9 educational support to reduce professional isolation 

10 through the timely dissemination of research findings 

11 using relevant resources. 

12 ‘‘(b) ELIGIBLE ENTITIES.—For purposes of this sec13 tion, the term ‘eligible entity’ means an entity described 

14 in section 799(b). 

15 ‘‘(c) APPLICATION.—An eligible entity desiring to re16 ceive an award under this section shall submit to the Sec17 retary an application at such time, in such manner, and 

18 containing such information as the Secretary may require. 

19 ‘‘(d) USE OF FUNDS.—An eligible entity shall use 

20 amounts awarded under a grant or contract under this 

21 section to provide innovative supportive activities to en22 hance education through distance learning, continuing 

23 educational activities, collaborative conferences, and elec24 tronic and telelearning activities, with priority for primary 

25 care. 


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1 ‘‘(e) AUTHORIZATION.—There is authorized to be ap2 propriated to carry out this section $5,000,000 for each 

3 of the fiscal years 2010 through 2014, and such sums as 

4 may be necessary for each subsequent fiscal year.’’. 

5 SEC. 454. WORKFORCE DIVERSITY GRANTS. 

6 Section 821 of the Public Health Service Act (42 

7 U.S.C. 296m) is amended— 

8 (1) in subsection (a)— 

9 (A) by striking ‘‘The Secretary may’’ and 

10 inserting the following: 

11 ‘‘(1) AUTHORITY.—The Secretary may’’; 

12 (B) by striking ‘‘pre-entry preparation, 

13 and retention activities’’ and inserting the fol14 lowing: ‘‘stipends for diploma or associate de15 gree nurses to enter a bridge or degree comple16 tion program, student scholarships or stipends 

17 for accelerated nursing degree programs, pre18 entry preparation, advanced education prepara19 tion, and retention activities’’; and 

20 (2) in subsection (b)— 

21 (A) by striking ‘‘First’’ and all that follows 

22 through ‘‘including the’’ and inserting ‘‘Na23 tional Advisory Council on Nurse Education 

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1 tions including the National Coalition of Ethnic 

2 Minority Nurse Associations,’’; and 

3 (B) by inserting before the period the fol4 lowing: ‘‘, and other organizations determined 

5 appropriate by the Secretary’’. 

6 SEC. 455. PRIMARY CARE EXTENSION PROGRAM. 

7 Part P of title III of the Public Health Service Act 

8 (42 U.S.C. 280g et seq.), as amended by section 443, is 

9 further amended by adding at the end the following: 

10 ‘‘SEC. 399V. PRIMARY CARE EXTENSION PROGRAM. 

11 ‘‘(a) ESTABLISHMENT, PURPOSE AND DEFINI12 TION.— 

13 ‘‘(1) IN GENERAL.—The Secretary, acting 

14 through the Director of the Agency for Healthcare 

15 Research and Quality, shall establish a Primary 

16 Care Extension Program. 

17 ‘‘(2) PURPOSE.—The Primary Care Extension 

18 Program shall provide support and assistance to pri19 mary care providers to educate providers about pre20 ventive medicine, health promotion, chronic disease 

21 management, mental and behavioral health services 

22 (including substance abuse prevention and treatment 

23 services), and evidence-based and evidence-informed 

24 therapies and techniques, in order to enable pro25 viders to incorporate such matters into their practice 


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1 and to improve community health by working with 

2 community-based health connectors (referred to in 

3 this section as ‘Health Extension Agents’). 

4 ‘‘(3) DEFINITIONS.—In this section: 

5 ‘‘(A) HEALTH EXTENSION AGENT.—The 

6 term ‘Health Extension Agent’ means any local, 

7 community-based health worker who facilitates 

8 and provides assistance to primary care prac9 tices by implementing quality improvement or 

10 system redesign, incorporating the principles of 

11 the patient-centered medical home to provide 

12 high-quality, effective, efficient, and safe pri13 mary care and to provide guidance to patients 

14 in culturally and linguistically appropriate ways, 

15 and linking practices to diverse health system 

16 resources. 

17 ‘‘(B) PRIMARY CARE PROVIDER.—The 

18 term ‘primary care provider’ means a clinician 

19 who provides integrated, accessible health care 

20 services and who is accountable for addressing 

21 a large majority of personal health care needs, 

22 including providing preventive and health pro23 motion services for men, women, and children 

24 of all ages, developing a sustained partnership 

25 with patients, and practicing in the context of 


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1 family and community, as recognized by a State 

2 licensing or regulatory authority, unless other3 wise specified in this section. 

4 ‘‘(b) GRANTS TO ESTABLISH STATE HUBS AND

5 LOCAL PRIMARY CARE EXTENSION AGENCIES.— 

6 ‘‘(1) GRANTS.—The Secretary shall award com7 petitive grants to States for the establishment of 

8 State- or multistate-level primary care Primary Care 

9 Extension Program State Hubs (referred to in this 

10 section as ‘Hubs’). 

11 ‘‘(2) COMPOSITION OF HUBS.—A Hub estab12 lished by a State pursuant to paragraph (1)— 

13 ‘‘(A) shall consist of, at a minimum, the 

14 State health department, the entity responsible 

15 for administering the State Medicaid program 

16 (if other than the State health department), the 

17 State-level entity administering the Medicare 

18 program, and the departments of 1 or more 

19 health professions schools in the State that 

20 train providers in primary care; and 

21 ‘‘(B) may include entities such as hospital 

22 associations, primary care practice-based re23 search networks, health professional societies, 

24 State primary care associations, State licensing 

25 boards, organizations with a contract with the 


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1 Secretary under section 1153 of the Social Se2 curity Act, consumer groups, and other appro3 priate entities. 

4 ‘‘(c) STATE AND LOCAL ACTIVITIES.— 

5 ‘‘(1) HUB ACTIVITIES.—Hubs established under 

6 a grant under subsection (b) shall— 

7 ‘‘(A) submit to the Secretary a plan to co8 ordinate functions with quality improvement or9 ganizations and area health education centers if 

10 such entities are members of the Hub not de11 scribed in subsection (b)(2)(A); 

12 ‘‘(B) contract with a county- or local-level 

13 entity that shall serve as the Primary Care Ex14 tension Agency to administer the services de15 scribed in paragraph (2); 

16 ‘‘(C) organize and administer grant funds 

17 to county- or local-level Primary Care Exten18 sion Agencies that serve a catchment area, as 

19 determined by the State; and 

20 ‘‘(D) organize State-wide or multistate net21 works of local-level Primary Care Extension 

22 Agencies to share and disseminate information 

23 and practices. 

24 ‘‘(2) LOCAL PRIMARY CARE EXTENSION AGENCY

25 ACTIVITIES.— 


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1 ‘‘(A) REQUIRED ACTIVITIES.—Primary 

2 Care Extension Agencies established by a Hub 

3 under paragraph (1) shall— 

4 ‘‘(i) assist primary care providers to 

5 implement a patient-centered medical home 

6 to improve the accessibility, quality, and 

7 efficiency of primary care services; 

8 ‘‘(ii) develop and support primary care 

9 learning communities to enhance the dis10 semination of research findings for evi11 dence-based practice, assess implementa12 tion of practice improvement, share best 

13 practices, and involve community clinicians 

14 in the generation of new knowledge and 

15 identification of important questions for 

16 research; 

17 ‘‘(iii) participate in a national network 

18 of Primary Care Extension Hubs and pro19 pose how the Primary Care Extension 

20 Agency will share and disseminate lessons 

21 learned and best practices; and 

22 ‘‘(iv) develop a plan for financial sus23 tainability involving State, local, and pri24 vate contributions, to provide for the re25 duction in Federal funds that is expected 


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1 after an initial 6-year period of program 

2 establishment, infrastructure development, 

3 and planning. 

4 ‘‘(B) DISCRETIONARY ACTIVITIES.—Pri5 mary Care Extension Agencies established by a 

6 Hub under paragraph (1) may— 

7 ‘‘(i) provide technical assistance, 

8 training, and organizational support for 

9 community health teams established under 

10 section 212 of the Affordable Health 

11 Choices Act; 

12 ‘‘(ii) collect data and provision of pri13 mary care provider feedback from stand14 ardized measurements of processes and 

15 outcomes to aid in continuous performance 

16 improvement; 

17 ‘‘(iii) collaborate with local health de18 partments, community health centers, 

19 tribes and tribal entities, and other com20 munity agencies to identify community 

21 health priorities and local health workforce 

22 needs, and participate in community-based 

23 efforts to address the social and primary 

24 determinants of health, strengthen the 


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1 local primary care workforce, and eliminate 

2 health disparities; 

3 ‘‘(iv) develop measures to monitor the 

4 impact of the proposed program on the 

5 health of practice enrollees and of the 

6 wider community served; and 

7 ‘‘(v) participate in other activities, as 

8 determined appropriate by the Secretary. 

9 ‘‘(d) FEDERAL PROGRAM ADMINISTRATION.— 

10 ‘‘(1) GRANTS; TYPES.—Grants awarded under 

11 subsection (b) shall be— 

12 ‘‘(A) program grants, that are awarded to 

13 State or multistate entities that submit fully-de14 veloped plans for the implementation of a Hub, 

15 for a period of 6 years; or 

16 ‘‘(B) planning grants, that are awarded to 

17 State or multistate entities with the goal of de18 veloping a plan for a Hub, for a period of 2 

19 years. 

20 ‘‘(2) APPLICATIONS.—To be eligible for a grant 

21 under subsection (b), a State or multistate entity 

22 shall submit to the Secretary an application, at such 

23 time, in such manner, and containing such informa24 tion as the Secretary may require. 


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1 ‘‘(3) EVALUATION.—A State that receives a 

2 grant under subsection (b) shall be evaluated at the 

3 end of the grant period by an evaluation panel ap4 pointed by the Secretary. 

5 ‘‘(4) CONTINUING SUPPORT.—After the sixth 

6 year in which assistance is provided to a State under 

7 a grant awarded under subsection (b), the State may 

8 receive additional support under this section if the 

9 State program has received satisfactory evaluations 

10 with respect to program performance and the merits 

11 of the State sustainability plan, as determined by 

12 the Secretary. 

13 ‘‘(5) LIMITATION.—A State shall not use in ex14 cess of 10 percent of the amount received under a 

15 grant to carry out administrative activities under 

16 this section. Funds awarded pursuant to this section 

17 shall not be used for funding direct patient care. 

18 ‘‘(e) REQUIREMENTS ON THE SECRETARY.—In car19 rying out this section, the Secretary shall consult with the 

20 heads of other Federal agencies with demonstrated experi21 ence and expertise in health care and preventive medicine, 

22 such as the Centers for Disease Control and Prevention, 

23 the Substance Abuse and Mental Health Administration, 

24 the Health Resources and Services Administration, the 

25 National Institutes of Health, the Office of the National 


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1 Coordinator for Health Information Technology, the In2 dian Health Service, the Agricultural Cooperative Exten3 sion Service of the Department of Agriculture, and other 

4 entities, as the Secretary determines appropriate. 

5 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

6 awards grants as provided in subsection (d), there are au7 thorized to be appropriated $120,000,000 for each of fis8 cal years 2011 and 2012, and such sums as may be nec9 essary to carry out this section for each of fiscal years 

10 2013 through 2014.’’. 

11 SEC. 456. DEFINITION OF ECONOMIC HARDSHIP. 

12 Section 435(o) of the Higher Education Act of 1965 

13 (20 U.S.C. 1085(o)) is amended— 

14 (1) in paragraph (1)— 

15 (A) in subparagraph (A)(ii), by striking 

16 ‘‘or’’ after the semicolon; 

17 (B) by redesignating subparagraph (B) as 

18 subparagraph (C); and 

19 (C) by inserting after subparagraph (A) 

20 the following: 

21 ‘‘(B) such borrower is working full-time 

22 and has a Federal educational debt burden that 

23 equals or exceeds 20 percent of such borrower’s 

24 adjusted gross income, and the difference be25 tween such borrower’s adjusted gross income 


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1 minus such burden is less than 220 percent of 

2 the greater of— 

3 ‘‘(i) the annual earnings of an indi4 vidual earning the minimum wage under 

5 section 6 of the Fair Labor Standards Act 

6 of 1938; or 

7 ‘‘(ii) 150 percent of the poverty line, 

8 as defined under section 673(2) of the 

9 Community Services Block Grant Act, ap10 plicable to such borrower’s family size; or’’; 

11 and 

12 (2) in paragraph (2), by striking ‘‘(1)(B)’’ and 

13 inserting ‘‘(1)(C)’’. 

14 Subtitle F—General Provisions 

15 SEC. 461. REPORTS. 

16 (a) REPORTS BY SECRETARY OF HEALTH AND

17 HUMAN SERVICES.—On an annual basis, the Secretary of 

18 Health and Human Services shall submit to the appro19 priate Committees of Congress a report on the activities 

20 carried out under the amendments made by this title, and 

21 the effectiveness of such activities. 

22 (b) REPORTS BY RECIPIENTS OF FUNDS.—The Sec23 retary of Health and Human Services may require, as a 

24 condition of receiving funds under the amendments made 

25 by this title, that the entity receiving such award submit 


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1 to such Secretary such reports as the such Secretary may 

2 require on activities carried out with such award, and the 

3 effectiveness of such activities. 

4 TITLE V—PREVENTING FRAUD 

5 AND ABUSE 

6 Subtitle A—Establishment of New 

7 Health and Human Services and 

8 Department of Justice Health 

9 Care Fraud Positions 

10 SEC. 501. HEALTH AND HUMAN SERVICES SENIOR ADVISOR. 

11 Part C of title XXVII of the Public Health Service 

12 Act (42 U.S.C. 300gg-91 et seq.) is amended— 

13 (1) by redesignating section 2792 as section 

14 2796; and 

15 (2) by inserting after section 2791, the fol16 lowing: 

17 ‘‘SEC. 2792. SENIOR ADVISOR FOR HEALTH CARE FRAUD. 

18 ‘‘(a) ESTABLISHMENT.—The Secretary shall appoint 

19 an individual to serve as the Senior Advisor for Health 

20 Care Fraud (referred to in this section as the ‘Senior Ad21 visor’) within the Office of the Deputy Secretary. The Sen22 ior Advisory shall be the principal advisor on policy and 

23 program development and oversight with respect to— 

24 ‘‘(1) the detection and prevention of health care 

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1 surance coverage and private health insurance cov2 erage; and 

3 ‘‘(2) the coordination of anti-fraud efforts with4 in the Department of Health and Human Services 

5 and with the Inspector General, the Department of 

6 Justice, other Federal agencies as appropriate, State 

7 and local law enforcement, State regulatory agen8 cies, and private health insurance coverage. 

9 ‘‘(b) REQUIREMENTS.—The Senior Advisor shall— 

10 ‘‘(1) be an officer or employee of the Depart11 ment of Health and Human Services designated by 

12 the Secretary for purposes of this section from 

13 among the career officers and employees of the De14 partment who have the experience and expertise nec15 essary to carry out the duties specified in subsection 

16 (a); or 

17 ‘‘(2) be an individual hired by the Secretary 

18 from the private sector from among individuals in 

19 the private sector who have the experience and ex20 pertise necessary to carry out the duties specified in 

21 subsection (a). 

22 ‘‘(c) DEFINITION.—In this section, the term ‘public 

23 health insurance coverage’ means coverage— 

24 ‘‘(1) provided under title XVIII, XIX, or XXI 

25 of the Social Security Act; 


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1 ‘‘(2) provided under the veteran’s health care 

2 program under chapter 17 of title 38, United States 

3 Code; 

4 ‘‘(3) provided through the Indian Health Serv5 ice; 

6 ‘‘(4) under the TRICARE program under chap7 ter 55 of title 10, United States Code; and 

8 ‘‘(5) under the Federal Employees Health Ben9 efits Program under chapter 89 of title 5, United 

10 States Code.’’. 

11 SEC. 502. DEPARTMENT OF JUSTICE POSITION. 

12 Chapter 41 of title 28, United States Code, is amend13 ed by adding at the end the following: 

14 ‘‘§ 614. Senior Counsel for Health Care Fraud En15 forcement 

16 ‘‘The Attorney General shall appoint an individual to 

17 serve as the Senior Counsel for Health Care Fraud En18 forcement (referred to in this section as the ‘Senior Coun19 sel’) within the Office of the Deputy Attorney General to 

20 serve as the principal advisor to the Attorney General on 

21 policy and program development and oversight with re22 spect to— 

23 ‘‘(1) the investigation and prosecution of health 

24 care fraud and abuse involving public and private 


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1 health insurance coverage (as defined in section 

2 2791 of the Public Health Service Act); and 

3 ‘‘(2) the coordination of such efforts within the 

4 Department of Justice and with the Inspector Gen5 eral, the Department of Health and Human Serv6 ices, other Federal agencies as appropriate, State 

7 and local law enforcement, State regulatory agen8 cies, and private health insurance coverage.’’. 

9 SEC. 503. REPORTS TO CONGRESS. 

10 (a) REPORTS.—The Senior Advisor for Health Care 

11 Fraud appointed under section 2792 of the Public Health 

12 Service Act and the Senior Counsel for Health Care Fraud 

13 Enforcement appointed under section 614 of title 28, 

14 United States Code, shall annually report to the Com15 mittee On Health, Education, Labor, and Pensions and 

16 the Committee on Finance of the Senate and the Com17 mittee on Ways and Means of the House of Representa18 tives regarding the detection and prevention of health care 

19 fraud, waste, and abuse involving public health insurance 

20 and private health insurance coverage. 

21 (b) DEFINITION.—In this section, the term ‘‘public 

22 health insurance coverage’’ means coverage— 

23 (1) provided under title XVIII, XIX, or XXI of 

24 the Social Security Act; 


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1 (2) provided under the veteran’s health care 

2 program under chapter 17 of title 38, United States 

3 Code; 

4 (3) provided through the Indian Health Service; 

5 (4) under the TRICARE program under chap6 ter 55 of title 10, United States Code; and 

7 (5) under the Federal Employees Health Bene8 fits Program under chapter 89 of title 5, United 

9 States Code. 

10 SEC. 504. FRAUD, WASTE, AND ABUSE COMMISSION. 

11 (a) ESTABLISHMENT.—Not later than 180 days after 

12 the date of enactment of this Act, the President shall es13 tablish a commission to be composed of representatives ap14 pointed by the President from insurers, employers, health 

15 care providers, anti-fraud organizations, consumers and 

16 patient groups, and Federal officials to review Federal 

17 health care programs and private health insurance with 

18 respect to policies and procedures to eliminate fraud, 

19 waste, and abuse under such programs and to more effec20 tively align public and private sector efforts to combat 

21 fraud, waste, and abuse. 

22 (b) PERIOD OF REVIEW.—The commission under 

23 subsection (a) shall review the programs involved for a pe24 riod of 2 years following the date on which such commis25 sion is established. 


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1 (c) REPORT.—Not later than 3 years after the date 

2 on which the commission under subsection (a) is estab3 lished, the commission shall submit to the Committee on 

4 Health, Education, Labor, and Pensions and the Com5 mittee on Finance of the Senate and the Committee on 

6 Ways and Means and the Committee on Energy and Com7 merce of the House of Representatives a report concerning 

8 the review conducted under such subsection. Such report 

9 shall include recommendations for modify such programs 

10 and other recommendations to better coordinate public 

11 and private efforts to combat fraud and abuse. 

12 (d) COOPERATION.—The President shall direct Fed13 eral officials to cooperate in the activities of the commis14 sion under this section. Commissioners shall have experi15 ence in fighting waste, fraud or abuse in the public and 

16 private sectors. 

17 (e) AUTHORIZATION OF APPROPRIATIONS.—There is 

18 authorized to be appropriated to carry out this section, 

19 $5,000,000. 

20 Subtitle B—Health Care Program 

21 Integrity Coordinating Council 

22 SEC. 511. ESTABLISHMENT. 

23 Part C of title XXVII of the Public Health Service 

24 Act (42 U.S.C. 300gg-91 et seq.), as amended by section 


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1 501, is further amended by inserting after section 2793, 

2 the following: 

3 ‘‘SEC. 2794. HEALTH CARE PROGRAM INTEGRITY COORDI4 NATING COUNCIL. 

5 ‘‘(a) ESTABLISHMENT.—There is established a coun6 cil to be known as the ‘Health Care Program Integrity 

7 Coordinating Council’ (referred to in this section as the 

8 ‘Council’). 

9 ‘‘(b) MEMBERSHIP.—The Council shall be composed 

10 of— 

11 ‘‘(1) the Secretary of Health and Human Serv12 ices; 

13 ‘‘(2) the Attorney General; 

14 ‘‘(3) the Inspector General for the Department 

15 of Health and Human Services; 

16 ‘‘(4) the Secretary of Labor; 

17 ‘‘(5) the Secretary of Defense; 

18 ‘‘(6) the Director of the Office of Personnel 

19 Management; 

20 ‘‘(7) the Under Secretary for Health for the 

21 Veterans Health Administration of the Department 

22 of Veterans Affairs; 

23 ‘‘(8) the Commissioner of the Social Security 

24 Administration; 


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1 ‘‘(9) the President of the National Association 

2 of Insurance Commissioners; 

3 ‘‘(10) the President of the National Association 

4 of Medicaid Fraud Control Units; 

5 ‘‘(11) the Comptroller General of the United 

6 States; 

7 ‘‘(12) the Inspector General of the Department 

8 of Labor; 

9 ‘‘(13) the Inspector General of the Department 

10 of Defense; 

11 ‘‘(14) the Inspector General of the Department 

12 of Veterans Affairs; 

13 ‘‘(15) the Inspector General of the Department 

14 of Justice; 

15 ‘‘(16) the chairperson and ranking member of 

16 relevant committees of jurisdiction of the Senate and 

17 the House of Representatives; and 

18 ‘‘(17) any other member, the appointment of 

19 whom a majority of the members of the Council de20 termines is necessary to carry out this title, except 

21 that an individual who is a representative of an enti22 ty subject to regulation under such Act shall not be 

23 appointed under this subparagraph. 

24 ‘‘(c) DUTIES.—The Council shall— 


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1 ‘‘(1) not later than 6 months after the date of 

2 enactment of this section, develop a strategic plan 

3 for improving the coordination and information shar4 ing among Federal agencies, State agencies, and pri5 vate health insurance coverage with respect to the 

6 prevention, detection, and control of fraud, waste, 

7 and abuse, including fraud and abuse of consumers 

8 of the health care program or private health insur9 ance issuers; 

10 ‘‘(2) annually submit to Congress a report on 

11 actions taken to implement the strategic plan re12 quired under paragraph (1); 

13 ‘‘(3) in carrying out the responsibilities identi14 fied under paragraph (1), evaluate ways to ensure 

15 that private health insurance coverage is included in 

16 investigative and data sharing programs, to the max17 imum extent feasible, with adequate protection pro18 vided for law enforcement-related data that is sen19 sitive because of concerns for the identities of crimi20 nal subjects or targets, and that recognizes that pri21 vate coverage may be responsible for fraud, waste, 

22 and abuse of public and policyholder funds; 

23 ‘‘(4) not later than 12 months after the date of 

24 enactment of this section, develop and issue guide25 lines for purposes of carrying out the strategic plan 


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1 under paragraph (1), recognizing that fraudulent ac2 tivity in the health care system can affect both pub3 lic and private sector health insurance coverage, and 

4 that the prevention, detection, investigation, and 

5 prosecution of fraud against private health insurance 

6 coverage is integral to the overall effort to combat 

7 health care fraud; 

8 ‘‘(5) at least once during every 5-year period, 

9 update the strategic plan issued pursuant to para10 graph (1) and the guidelines issued pursuant to 

11 paragraph (4); 

12 ‘‘(6) develop recommendations, in consultation 

13 with the Office of Management and Budget, for 

14 measures to estimate the amount of fraud, waste, 

15 and abuse in connection with public and private 

16 health insurance coverage, and the annual savings 

17 resulting from specific program integrity measures; 

18 ‘‘(7) identify improvements needed for purposes 

19 of information-sharing systems and activities used in 

20 implementing the strategic plan under paragraph 

21 (1); and 

22 ‘‘(8) establish a consultative panel composed of 

23 representatives of the private sector health insurance 

24 industry and consult with this panel in the formula25 tion of Council recommendations. 


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1 ‘‘(d) EXEMPTIONS.—The Council shall be exempt 

2 from— 

3 ‘‘(1) sections 553, 556, and 557 of title 5, 

4 United States Code, in the issuance of guidelines 

5 pursuant to subsection (c)(4); and 

6 ‘‘(2) the Federal Advisory Committee Act (5 

7 U.S.C. app.) in order to protect against the release 

8 of information which might undermine Federal, 

9 State, or local health care fraud control efforts. 

10 ‘‘(e) PUBLIC PARTICIPATION.—The Council shall 

11 provide for reasonable public participation in matters be12 fore the Council to the extent that such participation 

13 would not compromise the Council’s, or any other Federal, 

14 State, or local government entity’s, efforts to control 

15 health care fraud and abuse.’’. 

16 Subtitle C—False Statements and 

17 Representations 

18 SEC. 521. PROHIBITION ON FALSE STATEMENTS AND REP19 RESENTATIONS. 

20 (a) PROHIBITION.—Part 5 of subtitle B of title I of 

21 the Employee Retirement Income Security Act of 1974 

22 (29 U.S.C. 1131 et seq.) is amended by adding at the end 

23 the following: 


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1 ‘‘SEC. 519. PROHIBITION ON FALSE STATEMENTS AND REP2 RESENTATIONS. 

3 ‘‘No person, in connection with a plan or other ar4 rangement that is multiple employer welfare arrangement 

5 described in section 3(40), shall make a false statement 

6 or false representation of fact, knowing it to be false, in 

7 connection with the marketing or sale of such plan or ar8 rangement, to any employee, any member of an employee 

9 organization, any beneficiary, any employer, any employee 

10 organization, the Secretary, or any State, or the represent11 ative or agent of any such person, State, or the Secretary, 

12 concerning— 

13 ‘‘(1) the financial condition or solvency of such 

14 plan or arrangement; 

15 ‘‘(2) the benefits provided by such plan or ar16 rangement; 

17 ‘‘(3) the regulatory status of such plan or other 

18 arrangement under any Federal or State law gov19 erning collective bargaining, labor management rela20 tions, or intern union affairs; or 

21 ‘‘(4) the regulatory status of such plan or other 

22 arrangement regarding exemption from state regu23 latory authority under this Act. 

24 This section shall not apply to any plan or arrangement 

25 that does not fall within the meaning of the term ‘multiple 

26 employer welfare arrangement’ under section 3(40(A).’’. 


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1 (b) CRIMINAL PENALTIES.—Section 501 of the Em2 ployee Retirement Income Security Act of 1974 (29 

3 U.S.C. 1131) is amended— 

4 (1) by inserting ‘‘(a)’’ before ‘‘Any person’’; and 

5 (2) by adding at the end the following: 

6 ‘‘(b) Any person that violates section 519 shall upon 

7 conviction be imprisoned not more than 10 years or fined 

8 under title 18, United States Code, or both.’’. 

9 (c) CONFORMING AMENDMENT.—The table of sec10 tions for part 5 of subtitle B of title I of the Employee 

11 Retirement Income Security Act of 1974 is amended by 

12 adding at the end the following: 

‘‘Sec. 519. Prohibition on false statement and representations.’’. 

13 Subtitle D—Federal Health Care 

14 Offense 

15 SEC. 531. CLARIFYING DEFINITION. 

16 Section 24(a)(2) of title 18, United States Code, is 

17 amended by inserting ‘‘or section 411, 518, or 511 of the 

18 Employee Retirement Income Security Act of 1974,’’ after 

19 ‘‘1954 of this title’’. 

20 Subtitle E—Uniformity in Fraud 

21 and Abuse Reporting 

22 SEC. 541. DEVELOPMENT OF MODEL UNIFORM REPORT 

23 FORM. 

24 Part C of title XXVII of the Public Health Service 

25 Act (42 U.S.C. 300gg-91 et seq.), as amended by section 


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1 511, is further amended by inserting after section 2794, 

2 the following: 

3 ‘‘SEC. 2795. UNIFORM FRAUD AND ABUSE REFERRAL FOR4 MAT. 

5 ‘‘The Secretary shall request the National Associa6 tion of Insurance Commissioners to develop a model uni7 form report form for private health insurance issuer seek8 ing to refer suspected fraud and abuse to State insurance 

9 departments or other responsible State agencies for inves10 tigation. The Secretary shall request that the National As11 sociation of Insurance Commissioners develop rec12 ommendations for uniform reporting standards for such 

13 referrals.’’. 

14 Subtitle F—Applicability of State 

15 Law to Combat Fraud and Abuse 

16 SEC. 551. APPLICABILITY OF STATE LAW TO COMBAT 

17 FRAUD AND ABUSE. 

18 (a) IN GENERAL.—Part 5 of subtitle B of title I of 

19 the Employee Retirement Income Security Act of 1974 

20 (29 U.S.C. 1131 et seq.), as amended by section 521, is 

21 further amended by adding at the end the following: 

22 ‘‘SEC. 520. APPLICABILITY OF STATE LAW TO COMBAT 

23 FRAUD AND ABUSE. 

24 ‘‘The Secretary may, for the purpose of identifying, 

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1 latory standards establishing, or issue an order relating 

2 to a specific person establishing, that a person engaged 

3 in the business of providing insurance through a multiple 

4 employer welfare arrangement described in section 3(40) 

5 is subject to the laws of the States in which such person 

6 operates which regulate insurance in such State, notwith7 standing section 514(b)(6) of this Act or the Liability Risk 

8 Retention Act of 1986, and regardless of whether the law 

9 of the State is otherwise preempted under any of such pro10 visions. This section shall not apply to any plan or ar11 rangement that does not fall within the meaning of the 

12 term ‘multiple employer welfare arrangement’ under sec13 tion 3(40(A).’’. 

14 (b) CONFORMING AMENDMENT.—The table of sec15 tions for part 5 of subtitle B of title I of the Employee 

16 Retirement Income Security Act of 1974, as amended by 

17 section 521, is further amended by adding at the end the 

18 following: 

‘‘Sec. 520. Applicability of State law to combat fraud and abuse.’’. 


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1 Subtitle G—Enabling the Depart2 ment of Labor to Issue Adminis3 trative Summary Cease and De4 sist Orders and Summary Sei5 zures Orders Against Plans That 

6 Are in Financially Hazardous 

7 Condition 

8 SEC. 561. ENABLING THE DEPARTMENT OF LABOR TO 

9 ISSUE ADMINISTRATIVE SUMMARY CEASE 

10 AND DESIST ORDERS AND SUMMARY SEI11 ZURES ORDERS AGAINST PLANS THAT ARE IN 

12 FINANCIALLY HAZARDOUS CONDITION. 

13 (a) IN GENERAL.—Part 5 of subtitle B of title I of 

14 the Employee Retirement Income Security Act of 1974 

15 (29 U.S.C. 1131 et seq.), as amended by section 551, is 

16 further amended by adding at the end the following: 

17 ‘‘SEC. 521. ADMINISTRATIVE SUMMARY CEASE AND DESIST 

18 ORDERS AND SUMMARY SEIZURE ORDERS 

19 AGAINST MULTIPLE EMPLOYER WELFARE 

20 ARRANGEMENTS IN FINANCIALLY HAZ21 ARDOUS CONDITION. 

22 ‘‘(a) IN GENERAL.—The Secretary may issue a cease 

23 and desist (ex parte) order under this title if it appears 

24 to the Secretary that the alleged conduct of a multiple em25 ployer welfare arrangement described in section 3(40), 


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1 other than a plan or arrangement described in subsection 

2 (g), is fraudulent, or creates an immediate danger to the 

3 public safety or welfare, or is causing or can be reasonably 

4 expected to cause significant, imminent, and irreparable 

5 public injury. 

6 ‘‘(b) HEARING.—A person that is adversely affected 

7 by the issuance of a cease and desist order under sub8 section (a) may request a hearing by the Secretary regard9 ing such order. The Secretary may require that a pro10 ceeding under this section, including all related informa11 tion and evidence, be conducted in a confidential manner. 

12 ‘‘(c) BURDEN OF PROOF.—The burden of proof in 

13 any hearing conducted under subsection (b) shall be on 

14 the party requesting the hearing to show cause why the 

15 cease and desist order should be set aside. 

16 ‘‘(d) DETERMINATION.—Based upon the evidence 

17 presented at a hearing under subsection (b), the cease and 

18 desist order involved may be affirmed, modified, or set 

19 aside by the Secretary in whole or in part. 

20 ‘‘(e) SEIZURE.—The Secretary may issue a summary 

21 seizure order under this title if it appears that a multiple 

22 employer welfare arrangement is in a financially haz23 ardous condition. 


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1 ‘‘(f) REGULATIONS.—The Secretary may promulgate 

2 such regulations or other guidance as may be necessary 

3 or appropriate to carry out this section. 

4 ‘‘(g) EXCEPTION.—This section shall not apply to 

5 any plan or arrangement that does not fall within the 

6 meaning of the term ‘multiple employer welfare arrange7 ment’ under section 3(40(A).’’. 

8 (b) CONFORMING AMENDMENT.—The table of sec9 tions for part 5 of subtitle B of title I of the Employee 

10 Retirement Income Security Act of 1974, as amended by 

11 section 551, is further amended by adding at the end the 

12 following: 

‘‘Sec. 521. Administrative summary cease and desist orders and summary seizure orders against health plans in financially hazardous condition.’’. 

13 Subtitle H—Requiring Multiple 

14 Employer Welfare Arrangement 

15 (MEWA) Plans to File a Reg16 istration Form With the Depart17 ment of Labor Prior to Enroll18 ing Anyone in the Plan 

19 SEC. 571. MEWA PLAN REGISTRATION WITH DEPARTMENT 

20 OF LABOR. 

21 Section 101(g) of the Employee Retirement Income 

22 Security Act of 1974 (29 U.S.C. 1021(g)) is amended— 

23 (1) by striking ‘‘Secretary may’’ and inserting 

24 ‘‘Secretary shall’’; and 


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1 (2) by inserting ‘‘to register with the Secretary 

2 prior to operating in a State and may, by regulation, 

3 require such multiple employer welfare arrange4 ments’’ after ‘‘not group health plans’’. 

5 Subtitle I—Permitting Evidentiary 

6 Privilege and Confidential Com7 munications 

8 SEC. 581. PERMITTING EVIDENTIARY PRIVILEGE AND CON9 FIDENTIAL COMMUNICATIONS. 

10 Section 504 of the Employee Retirement Income Se11 curity Act of 1974 (29 U.S.C. 1134) is amended by adding 

12 at the end the following: 

13 ‘‘(d) The Secretary may promulgate a regulation that 

14 provides an evidentiary privilege for, and provides for the 

15 confidentiality of communications between or among, any 

16 of the following entities or their agents, consultants, or 

17 employees: 

18 ‘‘(1) A State insurance department. 

19 ‘‘(2) A State attorney general. 

20 ‘‘(3) The National Association of Insurance 

21 Commissioners. 

22 ‘‘(4) The Department of Labor. 

23 ‘‘(5) The Department of the Treasury. 

24 ‘‘(6) The Department of Justice. 


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1 ‘‘(7) The Department of Health and Human 

2 Services. 

3 ‘‘(8) Any other Federal or State authority that 

4 the Secretary determines is appropriate for the pur5 poses of enforcing the provisions of this title. 

6 ‘‘(e) The privilege established under subsection (d) 

7 shall apply to communications related to any investigation, 

8 audit, examination, or inquiry conducted or coordinated 

9 by any of the agencies. A communication that is privileged 

10 under subsection (d) shall not waive any privilege other11 wise available to the communicating agency or to any per12 son who provided the information that is communicated.’’. 

13 TITLE VI—IMPROVING ACCESS 

14 TO INNOVATIVE MEDICAL 

15 THERAPIES 

16 Subtitle A—Biologics Price 

17 Competition and Innovation 

18 SEC. 601. SHORT TITLE. 

19 (a) IN GENERAL.—This subtitle may be cited as the 

20 ‘‘Biologics Price Competition and Innovation Act of 

21 2009’’. 

22 (b) SENSE OF THE SENATE.—It is the sense of the 

23 Senate that a biosimilars pathway balancing innovation 

24 and consumer interests should be established. 


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1 SEC. 602. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI2 CAL PRODUCTS. 

3 (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO4 SIMILAR OR INTERCHANGEABLE.—Section 351 of the 

5 Public Health Service Act (42 U.S.C. 262) is amended— 

6 (1) in subsection (a)(1)(A), by inserting ‘‘under 

7 this subsection or subsection (k)’’ after ‘‘biologics li8 cense’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO11 SIMILAR OR INTERCHANGEABLE.— 

12 ‘‘(1) IN GENERAL.—Any person may submit an 

13 application for licensure of a biological product 

14 under this subsection. 

15 ‘‘(2) CONTENT.— 

16 ‘‘(A) IN GENERAL.— 

17 ‘‘(i) REQUIRED INFORMATION.—An 

18 application submitted under this subsection 

19 shall include information demonstrating 

20 that— 

21 ‘‘(I) the biological product is bio22 similar to a reference product based 

23 upon data derived from— 

24 ‘‘(aa) analytical studies that 

25 demonstrate that the biological 

26 product is highly similar to the 


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1 reference product notwith2 standing minor differences in 

3 clinically inactive components; 

4 ‘‘(bb) animal studies (includ5 ing the assessment of toxicity); 

6 and 

7 ‘‘(cc) a clinical study or 

8 studies (including the assessment 

9 of immunogenicity and phar10 macokinetics or 

11 pharmacodynamics) that are suf12 ficient to demonstrate safety, pu13 rity, and potency in 1 or more 

14 appropriate conditions of use for 

15 which the reference product is li16 censed and intended to be used 

17 and for which licensure is sought 

18 for the biological product; 

19 ‘‘(II) the biological product and 

20 reference product utilize the same 

21 mechanism or mechanisms of action 

22 for the condition or conditions of use 

23 prescribed, recommended, or sug24 gested in the proposed labeling, but 

25 only to the extent the mechanism or 


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1 mechanisms of action are known for 

2 the reference product; 

3 ‘‘(III) the condition or conditions 

4 of use prescribed, recommended, or 

5 suggested in the labeling proposed for 

6 the biological product have been pre7 viously approved for the reference 

8 product; 

9 ‘‘(IV) the route of administra10 tion, the dosage form, and the 

11 strength of the biological product are 

12 the same as those of the reference 

13 product; and 

14 ‘‘(V) the facility in which the bio15 logical product is manufactured, proc16 essed, packed, or held meets stand17 ards designed to assure that the bio18 logical product continues to be safe, 

19 pure, and potent. 

20 ‘‘(ii) DETERMINATION BY SEC21 RETARY.—The Secretary may determine, 

22 in the Secretary’s discretion, that an ele23 ment described in clause (i)(I) is unneces24 sary in an application submitted under this 

25 subsection. 


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1 ‘‘(iii) ADDITIONAL INFORMATION.— 

2 An application submitted under this sub3 section— 

4 ‘‘(I) shall include publicly-avail5 able information regarding the Sec6 retary’s previous determination that 

7 the reference product is safe, pure, 

8 and potent; and 

9 ‘‘(II) may include any additional 

10 information in support of the applica11 tion, including publicly-available infor12 mation with respect to the reference 

13 product or another biological product. 

14 ‘‘(B) INTERCHANGEABILITY.—An applica15 tion (or a supplement to an application) sub16 mitted under this subsection may include infor17 mation demonstrating that the biological prod18 uct meets the standards described in paragraph 

19 (4). 

20 ‘‘(3) EVALUATION BY SECRETARY.—Upon re21 view of an application (or a supplement to an appli22 cation) submitted under this subsection, the Sec23 retary shall license the biological product under this 

24 subsection if— 


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1 ‘‘(A) the Secretary determines that the in2 formation submitted in the application (or the 

3 supplement) is sufficient to show that the bio4 logical product— 

5 ‘‘(i) is biosimilar to the reference 

6 product; or 

7 ‘‘(ii) meets the standards described in 

8 paragraph (4), and therefore is inter9 changeable with the reference product; and 

10 ‘‘(B) the applicant (or other appropriate 

11 person) consents to the inspection of the facility 

12 that is the subject of the application, in accord13 ance with subsection (c). 

14 ‘‘(4) SAFETY STANDARDS FOR DETERMINING

15 INTERCHANGEABILITY.—Upon review of an applica16 tion submitted under this subsection or any supple17 ment to such application, the Secretary shall deter18 mine the biological product to be interchangeable 

19 with the reference product if the Secretary deter20 mines that the information submitted in the applica21 tion (or a supplement to such application) is suffi22 cient to show that— 

23 ‘‘(A) the biological product— 

24 ‘‘(i) is biosimilar to the reference 

25 product; and 


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1 ‘‘(ii) can be expected to produce the 

2 same clinical result as the reference prod3 uct in any given patient; and 

4 ‘‘(B) for a biological product that is ad5 ministered more than once to an individual, the 

6 risk in terms of safety or diminished efficacy of 

7 alternating or switching between use of the bio8 logical product and the reference product is not 

9 greater than the risk of using the reference 

10 product without such alternation or switch. 

11 ‘‘(5) GENERAL RULES.— 

12 ‘‘(A) ONE REFERENCE PRODUCT PER AP13 PLICATION.—A biological product, in an appli14 cation submitted under this subsection, may not 

15 be evaluated against more than 1 reference 

16 product. 

17 ‘‘(B) REVIEW.—An application submitted 

18 under this subsection shall be reviewed by the 

19 division within the Food and Drug Administra20 tion that is responsible for the review and ap21 proval of the application under which the ref22 erence product is licensed. 

23 ‘‘(C) RISK EVALUATION AND MITIGATION

24 STRATEGIES.—The authority of the Secretary 

25 with respect to risk evaluation and mitigation 


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1 strategies under the Federal Food, Drug, and 

2 Cosmetic Act shall apply to biological products 

3 licensed under this subsection in the same man4 ner as such authority applies to biological prod5 ucts licensed under subsection (a). 

6 ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE7 ABLE BIOLOGICAL PRODUCT.—Upon review of an 

8 application submitted under this subsection relying 

9 on the same reference product for which a prior bio10 logical product has received a determination of inter11 changeability for any condition of use, the Secretary 

12 shall not make a determination under paragraph (4) 

13 that the second or subsequent biological product is 

14 interchangeable for any condition of use until the 

15 earlier of— 

16 ‘‘(A) 1 year after the first commercial 

17 marketing of the first interchangeable bio18 similar biological product to be approved as 

19 interchangeable for that reference product; 

20 ‘‘(B) 18 months after— 

21 ‘‘(i) a final court decision on all pat22 ents in suit in an action instituted under 

23 subsection (l)(6) against the applicant that 

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1 proved interchangeable biosimilar biological 

2 product; or 

3 ‘‘(ii) the dismissal with or without 

4 prejudice of an action instituted under sub5 section (l)(6) against the applicant that 

6 submitted the application for the first ap7 proved interchangeable biosimilar biological 

8 product; or 

9 ‘‘(C)(i) 42 months after approval of the 

10 first interchangeable biosimilar biological prod11 uct if the applicant that submitted such appli12 cation has been sued under subsection (l)(6) 

13 and such litigation is still ongoing within such 

14 42-month period; or 

15 ‘‘(ii) 18 months after approval of the first 

16 interchangeable biosimilar biological product if 

17 the applicant that submitted such application 

18 has not been sued under subsection (l)(6). 

19 For purposes of this paragraph, the term ‘final court 

20 decision’ means a final decision of a court from 

21 which no appeal (other than a petition to the United 

22 States Supreme Court for a writ of certiorari) has 

23 been or can be taken. 

24 ‘‘(7) EXCLUSIVITY FOR REFERENCE PROD25 UCT.— 


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1 ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP2 PLICATION APPROVAL.—Approval of an applica3 tion under this subsection may not be made ef4 fective by the Secretary until the date that is 

5 12 years after the date on which the reference 

6 product was first licensed under subsection (a). 

7 ‘‘(B) FILING PERIOD.—An application 

8 under this subsection may not be submitted to 

9 the Secretary until the date that is 4 years 

10 after the date on which the reference product 

11 was first licensed under subsection (a). 

12 ‘‘(C) FIRST LICENSURE.—Subparagraphs 

13 (A) and (B) shall not apply to a license for or 

14 approval of— 

15 ‘‘(i) a supplement for the biological 

16 product that is the reference product; or 

17 ‘‘(ii) a subsequent application filed by 

18 the same sponsor or manufacturer of the 

19 biological product that is the reference 

20 product (or a licensor, predecessor in inter21 est, or other related entity) for— 

22 ‘‘(I) a change (not including a 

23 modification to the structure of the bi24 ological product) that results in a new 

25 indication, route of administration, 


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1 dosing schedule, dosage form, delivery 

2 system, delivery device, or strength; or 

3 ‘‘(II) a modification to the struc4 ture of the biological product that 

5 does not result in a change in safety, 

6 purity, or potency. 

7 ‘‘(8) GUIDANCE DOCUMENTS.— 

8 ‘‘(A) IN GENERAL.—The Secretary may, 

9 after opportunity for public comment, issue 

10 guidance in accordance, except as provided in 

11 subparagraph (B)(i), with section 701(h) of the 

12 Federal Food, Drug, and Cosmetic Act with re13 spect to the licensure of a biological product 

14 under this subsection. Any such guidance may 

15 be general or specific. 

16 ‘‘(B) PUBLIC COMMENT.— 

17 ‘‘(i) IN GENERAL.—The Secretary 

18 shall provide the public an opportunity to 

19 comment on any proposed guidance issued 

20 under subparagraph (A) before issuing 

21 final guidance. 

22 ‘‘(ii) INPUT REGARDING MOST VALU23 ABLE GUIDANCE.—The Secretary shall es24 tablish a process through which the public 


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1 may provide the Secretary with input re2 garding priorities for issuing guidance. 

3 ‘‘(C) NO REQUIREMENT FOR APPLICATION

4 CONSIDERATION.—The issuance (or non5 issuance) of guidance under subparagraph (A) 

6 shall not preclude the review of, or action on, 

7 an application submitted under this subsection. 

8 ‘‘(D) REQUIREMENT FOR PRODUCT CLASS9 SPECIFIC GUIDANCE.—If the Secretary issues 

10 product class-specific guidance under subpara11 graph (A), such guidance shall include a de12 scription of— 

13 ‘‘(i) the criteria that the Secretary will 

14 use to determine whether a biological prod15 uct is highly similar to a reference product 

16 in such product class; and 

17 ‘‘(ii) the criteria, if available, that the 

18 Secretary will use to determine whether a 

19 biological product meets the standards de20 scribed in paragraph (4). 

21 ‘‘(E) CERTAIN PRODUCT CLASSES.— 

22 ‘‘(i) GUIDANCE.—The Secretary may 

23 indicate in a guidance document that the 

24 science and experience, as of the date of 

25 such guidance, with respect to a product or 


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1 product class (not including any recom2 binant protein) does not allow approval of 

3 an application for a license as provided 

4 under this subsection for such product or 

5 product class. 

6 ‘‘(ii) MODIFICATION OR REVERSAL.— 

7 The Secretary may issue a subsequent 

8 guidance document under subparagraph 

9 (A) to modify or reverse a guidance docu10 ment under clause (i). 

11 ‘‘(iii) NO EFFECT ON ABILITY TO

12 DENY LICENSE.—Clause (i) shall not be 

13 construed to require the Secretary to ap14 prove a product with respect to which the 

15 Secretary has not indicated in a guidance 

16 document that the science and experience, 

17 as described in clause (i), does not allow 

18 approval of such an application. 

19 ‘‘(l) PATENTS.— 

20 ‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION

21 (k) APPLICATION.— 

22 ‘‘(A) APPLICATION OF PARAGRAPH.—Un23 less otherwise agreed to by a person that sub24 mits an application under subsection (k) (re25 ferred to in this subsection as the ‘subsection 


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1 (k) applicant’) and the sponsor of the applica2 tion for the reference product (referred to in 

3 this subsection as the ‘reference product spon4 sor’), the provisions of this paragraph shall 

5 apply to the exchange of information described 

6 in this subsection. 

7 ‘‘(B) IN GENERAL.— 

8 ‘‘(i) PROVISION OF CONFIDENTIAL IN9 FORMATION.—When a subsection (k) ap10 plicant submits an application under sub11 section (k), such applicant shall provide to 

12 the persons described in clause (ii), subject 

13 to the terms of this paragraph, confidential 

14 access to the information required to be 

15 produced pursuant to paragraph (2) and 

16 any other information that the subsection 

17 (k) applicant determines, in its sole discre18 tion, to be appropriate (referred to in this 

19 subsection as the ‘confidential informa20 tion’). 

21 ‘‘(ii) RECIPIENTS OF INFORMATION.— 

22 The persons described in this clause are 

23 the following: 

24 ‘‘(I) OUTSIDE COUNSEL.—One or 

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1 erence product sponsor who are em2 ployees of an entity other than the 

3 reference product sponsor (referred to 

4 in this paragraph as the ‘outside 

5 counsel’), provided that such attor6 neys do not engage, formally or infor7 mally, in patent prosecution relevant 

8 or related to the reference product. 

9 ‘‘(II) IN-HOUSE COUNSEL.—One 

10 attorney that represents the reference 

11 product sponsor who is an employee 

12 of the reference product sponsor, pro13 vided that such attorney does not en14 gage, formally or informally, in patent 

15 prosecution relevant or related to the 

16 reference product. 

17 ‘‘(iii) PATENT OWNER ACCESS.—A 

18 representative of the owner of a patent ex19 clusively licensed to a reference product 

20 sponsor with respect to the reference prod21 uct and who has retained a right to assert 

22 the patent or participate in litigation con23 cerning the patent may be provided the 

24 confidential information, provided that the 

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1 uct sponsor and the subsection (k) appli2 cant of his or her agreement to be subject 

3 to the confidentiality provisions set forth in 

4 this paragraph, including those under 

5 clause (ii). 

6 ‘‘(C) LIMITATION ON DISCLOSURE.—No 

7 person that receives confidential information 

8 pursuant to subparagraph (B) shall disclose 

9 any confidential information to any other per10 son or entity, including the reference product 

11 sponsor employees, outside scientific consult12 ants, or other outside counsel retained by the 

13 reference product sponsor, without the prior 

14 written consent of the subsection (k) applicant, 

15 which shall not be unreasonably withheld. 

16 ‘‘(D) USE OF CONFIDENTIAL INFORMA17 TION.—Confidential information shall be used 

18 for the sole and exclusive purpose of deter19 mining, with respect to each patent assigned to 

20 or exclusively licensed by the reference product 

21 sponsor, whether a claim of patent infringement 

22 could reasonably be asserted if the subsection 

23 (k) applicant engaged in the manufacture, use, 

24 offering for sale, sale, or importation into the 

25 United States of the biological product that is 


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1 the subject of the application under subsection 

2 (k). 

3 ‘‘(E) OWNERSHIP OF CONFIDENTIAL IN4 FORMATION.—The confidential information dis5 closed under this paragraph is, and shall re6 main, the property of the subsection (k) appli7 cant. By providing the confidential information 

8 pursuant to this paragraph, the subsection (k) 

9 applicant does not provide the reference product 

10 sponsor or the outside counsel any interest in or 

11 license to use the confidential information, for 

12 purposes other than those specified in subpara13 graph (D). 

14 ‘‘(F) EFFECT OF INFRINGEMENT AC15 TION.—In the event that the reference product 

16 sponsor files a patent infringement suit, the use 

17 of confidential information shall continue to be 

18 governed by the terms of this paragraph until 

19 such time as a court enters a protective order 

20 regarding the information. Upon entry of such 

21 order, the subsection (k) applicant may redesig22 nate confidential information in accordance 

23 with the terms of that order. No confidential in24 formation shall be included in any publicly25 available complaint or other pleading. In the 


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1 event that the reference product sponsor does 

2 not file an infringement action by the date spec3 ified in paragraph (6), the reference product 

4 sponsor shall return or destroy all confidential 

5 information received under this paragraph, pro6 vided that if the reference product sponsor opts 

7 to destroy such information, it will confirm de8 struction in writing to the subsection (k) appli9 cant. 

10 ‘‘(G) RULE OF CONSTRUCTION.—Nothing 

11 in this paragraph shall be construed— 

12 ‘‘(i) as an admission by the subsection 

13 (k) applicant regarding the validity, en14 forceability, or infringement of any patent; 

15 or 

16 ‘‘(ii) as an agreement or admission by 

17 the subsection (k) applicant with respect to 

18 the competency, relevance, or materiality 

19 of any confidential information. 

20 ‘‘(H) EFFECT OF VIOLATION.—The disclo21 sure of any confidential information in violation 

22 of this paragraph shall be deemed to cause the 

23 subsection (k) applicant to suffer irreparable 

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1 junctive relief to be an appropriate and nec2 essary remedy for any violation or threatened 

3 violation of this paragraph. 

4 ‘‘(2) SUBSECTION (k) APPLICATION INFORMA5 TION.—Not later than 20 days after the Secretary 

6 notifies the subsection (k) applicant that the applica7 tion has been accepted for review, the subsection (k) 

8 applicant— 

9 ‘‘(A) shall provide to the reference product 

10 sponsor a copy of the application submitted to 

11 the Secretary under subsection (k), and such 

12 other information that describes the process or 

13 processes used to manufacture the biological 

14 product that is the subject of such application; 

15 and 

16 ‘‘(B) may provide to the reference product 

17 sponsor additional information requested by or 

18 on behalf of the reference product sponsor. 

19 ‘‘(3) LIST AND DESCRIPTION OF PATENTS.— 

20 ‘‘(A) LIST BY REFERENCE PRODUCT SPON21 SOR.—Not later than 60 days after the receipt 

22 of the application and information under para23 graph (2), the reference product sponsor shall 

24 provide to the subsection (k) applicant— 


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1 ‘‘(i) a list of patents for which the ref2 erence product sponsor believes a claim of 

3 patent infringement could reasonably be 

4 asserted by the reference product sponsor, 

5 or by a patent owner that has granted an 

6 exclusive license to the reference product 

7 sponsor with respect to the reference prod8 uct, if a person not licensed by the ref9 erence product sponsor engaged in the 

10 making, using, offering to sell, selling, or 

11 importing into the United States of the bi12 ological product that is the subject of the 

13 subsection (k) application; and 

14 ‘‘(ii) an identification of the patents 

15 on such list that the reference product 

16 sponsor would be prepared to license to the 

17 subsection (k) applicant. 

18 ‘‘(B) LIST AND DESCRIPTION BY SUB19 SECTION (k) APPLICANT.—Not later than 60 

20 days after receipt of the list under subpara21 graph (A), the subsection (k) applicant— 

22 ‘‘(i) may provide to the reference 

23 product sponsor a list of patents to which 

24 the subsection (k) applicant believes a 

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1 ably be asserted by the reference product 

2 sponsor if a person not licensed by the ref3 erence product sponsor engaged in the 

4 making, using, offering to sell, selling, or 

5 importing into the United States of the bi6 ological product that is the subject of the 

7 subsection (k) application; 

8 ‘‘(ii) shall provide to the reference 

9 product sponsor, with respect to each pat10 ent listed by the reference product sponsor 

11 under subparagraph (A) or listed by the 

12 subsection (k) applicant under clause (i)— 

13 ‘‘(I) a detailed statement that de14 scribes, on a claim by claim basis, the 

15 factual and legal basis of the opinion 

16 of the subsection (k) applicant that 

17 such patent is invalid, unenforceable, 

18 or will not be infringed by the com19 mercial marketing of the biological 

20 product that is the subject of the sub21 section (k) application; or 

22 ‘‘(II) a statement that the sub23 section (k) applicant does not intend 

24 to begin commercial marketing of the 


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1 biological product before the date that 

2 such patent expires; and 

3 ‘‘(iii) shall provide to the reference 

4 product sponsor a response regarding each 

5 patent identified by the reference product 

6 sponsor under subparagraph (A)(ii). 

7 ‘‘(C) DESCRIPTION BY REFERENCE PROD8 UCT SPONSOR.—Not later than 60 days after 

9 receipt of the list and statement under subpara10 graph (B), the reference product sponsor shall 

11 provide to the subsection (k) applicant a de12 tailed statement that describes, with respect to 

13 each patent described in subparagraph 

14 (B)(ii)(I), on a claim by claim basis, the factual 

15 and legal basis of the opinion of the reference 

16 product sponsor that such patent will be in17 fringed by the commercial marketing of the bio18 logical product that is the subject of the sub19 section (k) application and a response to the 

20 statement concerning validity and enforceability 

21 provided under subparagraph (B)(ii)(I). 

22 ‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— 

23 ‘‘(A) IN GENERAL.—After receipt by the 

24 subsection (k) applicant of the statement under 

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1 sor and the subsection (k) applicant shall en2 gage in good faith negotiations to agree on 

3 which, if any, patents listed under paragraph 

4 (3) by the subsection (k) applicant or the ref5 erence product sponsor shall be the subject of 

6 an action for patent infringement under para7 graph (6). 

8 ‘‘(B) FAILURE TO REACH AGREEMENT.— 

9 If, within 15 days of beginning negotiations 

10 under subparagraph (A), the subsection (k) ap11 plicant and the reference product sponsor fail to 

12 agree on a final and complete list of which, if 

13 any, patents listed under paragraph (3) by the 

14 subsection (k) applicant or the reference prod15 uct sponsor shall be the subject of an action for 

16 patent infringement under paragraph (6), the 

17 provisions of paragraph (5) shall apply to the 

18 parties. 

19 ‘‘(5) PATENT RESOLUTION IF NO AGREE20 MENT.— 

21 ‘‘(A) NUMBER OF PATENTS.—The sub22 section (k) applicant shall notify the reference 

23 product sponsor of the number of patents that 

24 such applicant will provide to the reference 

25 product sponsor under subparagraph (B)(i)(I). 


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1 ‘‘(B) EXCHANGE OF PATENT LISTS.— 

2 ‘‘(i) IN GENERAL.—On a date agreed 

3 to by the subsection (k) applicant and the 

4 reference product sponsor, but in no case 

5 later than 5 days after the subsection (k) 

6 applicant notifies the reference product 

7 sponsor under subparagraph (A), the sub8 section (k) applicant and the reference 

9 product sponsor shall simultaneously ex10 change— 

11 ‘‘(I) the list of patents that the 

12 subsection (k) applicant believes 

13 should be the subject of an action for 

14 patent infringement under paragraph 

15 (6); and 

16 ‘‘(II) the list of patents, in ac17 cordance with clause (ii), that the ref18 erence product sponsor believes should 

19 be the subject of an action for patent 

20 infringement under paragraph (6). 

21 ‘‘(ii) NUMBER OF PATENTS LISTED BY

22 REFERENCE PRODUCT SPONSOR.— 

23 ‘‘(I) IN GENERAL.—Subject to 

24 subclause (II), the number of patents 

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1 sor under clause (i)(II) may not ex2 ceed the number of patents listed by 

3 the subsection (k) applicant under 

4 clause (i)(I). 

5 ‘‘(II) EXCEPTION.—If a sub6 section (k) applicant does not list any 

7 patent under clause (i)(I), the ref8 erence product sponsor may list 1 pat9 ent under clause (i)(II). 

10 ‘‘(6) IMMEDIATE PATENT INFRINGEMENT AC11 TION.— 

12 ‘‘(A) ACTION IF AGREEMENT ON PATENT

13 LIST.—If the subsection (k) applicant and the 

14 reference product sponsor agree on patents as 

15 described in paragraph (4), not later than 30 

16 days after such agreement, the reference prod17 uct sponsor shall bring an action for patent in18 fringement with respect to each such patent. 

19 ‘‘(B) ACTION IF NO AGREEMENT ON PAT20 ENT LIST.—If the provisions of paragraph (5) 

21 apply to the parties as described in paragraph 

22 (4)(B), not later than 30 days after the ex23 change of lists under paragraph (5)(B), the ref24 erence product sponsor shall bring an action for 


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1 patent infringement with respect to each patent 

2 that is included on such lists. 

3 ‘‘(C) NOTIFICATION AND PUBLICATION OF

4 COMPLAINT.— 

5 ‘‘(i) NOTIFICATION TO SECRETARY.— 

6 Not later than 30 days after a complaint 

7 is served to a subsection (k) applicant in 

8 an action for patent infringement described 

9 under this paragraph, the subsection (k) 

10 applicant shall provide the Secretary with 

11 notice and a copy of such complaint. 

12 ‘‘(ii) PUBLICATION BY SECRETARY.— 

13 The Secretary shall publish in the Federal 

14 Register notice of a complaint received 

15 under clause (i). 

16 ‘‘(7) NEWLY ISSUED OR LICENSED PATENTS.— 

17 In the case of a patent that— 

18 ‘‘(A) is issued to, or exclusively licensed by, 

19 the reference product sponsor after the date 

20 that the reference product sponsor provided the 

21 list to the subsection (k) applicant under para22 graph (3)(A); and 

23 ‘‘(B) the reference product sponsor reason24 ably believes that, due to the issuance of such 

25 patent, a claim of patent infringement could 


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1 reasonably be asserted by the reference product 

2 sponsor if a person not licensed by the ref3 erence product sponsor engaged in the making, 

4 using, offering to sell, selling, or importing into 

5 the United States of the biological product that 

6 is the subject of the subsection (k) application, 

7 not later than 30 days after such issuance or licens8 ing, the reference product sponsor shall provide to 

9 the subsection (k) applicant a supplement to the list 

10 provided by the reference product sponsor under 

11 paragraph (3)(A) that includes such patent, not 

12 later than 30 days after such supplement is pro13 vided, the subsection (k) applicant shall provide a 

14 statement to the reference product sponsor in ac15 cordance with paragraph (3)(B), and such patent 

16 shall be subject to paragraph (8). 

17 ‘‘(8) NOTICE OF COMMERCIAL MARKETING AND

18 PRELIMINARY INJUNCTION.— 

19 ‘‘(A) NOTICE OF COMMERCIAL MAR20 KETING.—The subsection (k) applicant shall 

21 provide notice to the reference product sponsor 

22 not later than 180 days before the date of the 

23 first commercial marketing of the biological 

24 product licensed under subsection (k). 


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1 ‘‘(B) PRELIMINARY INJUNCTION.—After 

2 receiving the notice under subparagraph (A) 

3 and before such date of the first commercial 

4 marketing of such biological product, the ref5 erence product sponsor may seek a preliminary 

6 injunction prohibiting the subsection (k) appli7 cant from engaging in the commercial manufac8 ture or sale of such biological product until the 

9 court decides the issue of patent validity, en10 forcement, and infringement with respect to any 

11 patent that is— 

12 ‘‘(i) included in the list provided by 

13 the reference product sponsor under para14 graph (3)(A) or in the list provided by the 

15 subsection (k) applicant under paragraph 

16 (3)(B); and 

17 ‘‘(ii) not included, as applicable, on— 

18 ‘‘(I) the list of patents described 

19 in paragraph (4); or 

20 ‘‘(II) the lists of patents de21 scribed in paragraph (5)(B). 

22 ‘‘(C) REASONABLE COOPERATION.—If the 

23 reference product sponsor has sought a prelimi24 nary injunction under subparagraph (B), the 

25 reference product sponsor and the subsection 


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1 (k) applicant shall reasonably cooperate to ex2 pedite such further discovery as is needed in 

3 connection with the preliminary injunction mo4 tion. 

5 ‘‘(9) LIMITATION ON DECLARATORY JUDGMENT

6 ACTION.— 

7 ‘‘(A) SUBSECTION (k) APPLICATION PRO8 VIDED.—If a subsection (k) applicant provides 

9 the application and information required under 

10 paragraph (2)(A), neither the reference product 

11 sponsor nor the subsection (k) applicant may, 

12 prior to the date notice is received under para13 graph (8)(A), bring any action under section 

14 2201 of title 28, United States Code, for a dec15 laration of infringement, validity, or enforce16 ability of any patent that is described in clauses 

17 (i) and (ii) of paragraph (8)(B). 

18 ‘‘(B) SUBSEQUENT FAILURE TO ACT BY

19 SUBSECTION (k) APPLICANT.—If a subsection 

20 (k) applicant fails to complete an action re21 quired of the subsection (k) applicant under 

22 paragraph (3)(B)(ii), paragraph (5), paragraph 

23 (6)(C)(i), paragraph (7), or paragraph (8)(A), 

24 the reference product sponsor, but not the sub25 section (k) applicant, may bring an action 


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1 under section 2201 of title 28, United States 

2 Code, for a declaration of infringement, validity, 

3 or enforceability of any patent included in the 

4 list described in paragraph (3)(A), including as 

5 provided under paragraph (7). 

6 ‘‘(C) SUBSECTION (k) APPLICATION NOT

7 PROVIDED.—If a subsection (k) applicant fails 

8 to provide the application and information re9 quired under paragraph (2)(A), the reference 

10 product sponsor, but not the subsection (k) ap11 plicant, may bring an action under section 2201 

12 of title 28, United States Code, for a declara13 tion of infringement, validity, or enforceability 

14 of any patent that claims the biological product 

15 or a use of the biological product.’’. 

16 (b) DEFINITIONS.—Section 351(i) of the Public 

17 Health Service Act (42 U.S.C. 262(i)) is amended— 

18 (1) by striking ‘‘In this section, the term ‘bio19 logical product’ means’’ and inserting the following: 

20 ‘‘In this section: 

21 ‘‘(1) The term ‘biological product’ means’’; 

22 (2) in paragraph (1), as so designated, by in23 serting ‘‘protein (except any chemically synthesized 

24 polypeptide),’’ after ‘‘allergenic product,’’; and 

25 (3) by adding at the end the following: 


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1 ‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 

2 reference to a biological product that is the subject 

3 of an application under subsection (k), means— 

4 ‘‘(A) that the biological product is highly 

5 similar to the reference product notwith6 standing minor differences in clinically inactive 

7 components; and 

8 ‘‘(B) there are no clinically meaningful dif9 ferences between the biological product and the 

10 reference product in terms of the safety, purity, 

11 and potency of the product. 

12 ‘‘(3) The term ‘interchangeable’ or ‘inter13 changeability’, in reference to a biological product 

14 that is shown to meet the standards described in 

15 subsection (k)(4), means that the biological product 

16 may be substituted for the reference product without 

17 the intervention of the health care provider who pre18 scribed the reference product. 

19 ‘‘(4) The term ‘reference product’ means the 

20 single biological product licensed under subsection 

21 (a) against which a biological product is evaluated in 

22 an application submitted under subsection (k).’’. 

23 (c) CONFORMING AMENDMENTS RELATING TO PAT24 ENTS.— 


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1 (1) PATENTS.—Section 271(e) of title 35, 

2 United States Code, is amended— 

3 (A) in paragraph (2)— 

4 (i) in subparagraph (A), by striking 

5 ‘‘or’’ at the end; 

6 (ii) in subparagraph (B), by adding 

7 ‘‘or’’ at the end; and 

8 (iii) by inserting after subparagraph 

9 (B) the following: 

10 ‘‘(C)(i) with respect to a patent that is identi11 fied in the list of patents described in section 

12 351(l)(3) of the Public Health Service Act (including 

13 as provided under section 351(l)(7) of such Act), an 

14 application seeking approval of a biological product, 

15 or 

16 ‘‘(ii) if the applicant for the application fails to 

17 provide the application and information required 

18 under section 351(l)(2)(A) of such Act, an applica19 tion seeking approval of a biological product for a 

20 patent that could be identified pursuant to section 

21 351(l)(3)(A)(i) of such Act,’’; and 

22 (iv) in the matter following subpara23 graph (C) (as added by clause (iii)), by 

24 striking ‘‘or veterinary biological product’’ 


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1 and inserting ‘‘, veterinary biological prod2 uct, or biological product’’; 

3 (B) in paragraph (4)— 

4 (i) in subparagraph (B), by— 

5 (I) striking ‘‘or veterinary bio6 logical product’’ and inserting ‘‘, vet7 erinary biological product, or biologi8 cal product’’; and 

9 (II) striking ‘‘and’’ at the end; 

10 (ii) in subparagraph (C), by— 

11 (I) striking ‘‘or veterinary bio12 logical product’’ and inserting ‘‘, vet13 erinary biological product, or biologi14 cal product’’; and 

15 (II) striking the period and in16 serting ‘‘, and’’; 

17 (iii) by inserting after subparagraph 

18 (C) the following: 

19 ‘‘(D) the court shall order a permanent injunc20 tion prohibiting any infringement of the patent by 

21 the biological product involved in the infringement 

22 until a date which is not earlier than the date of the 

23 expiration of the patent that has been infringed 

24 under paragraph (2)(C), provided the patent is the 

25 subject of a final court decision, as defined in secVerDate Nov 24 2008 22:22 Sep 17, 2009 Jkt 079200 PO 00000 Frm 00806 Fmt 6652 Sfmt 6201 E:\BILLS\S1679.PCS S1679

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1 tion 351(k)(6) of the Public Health Service Act, in 

2 an action for infringement of the patent under sec3 tion 351(l)(6) of such Act, and the biological prod4 uct has not yet been approved because of section 

5 351(k)(7) of such Act.’’; and 

6 (iv) in the matter following subpara7 graph (D) (as added by clause (iii)), by 

8 striking ‘‘and (C)’’ and inserting ‘‘(C), and 

9 (D)’’; and 

10 (C) by adding at the end the following: 

11 ‘‘(6)(A) Subparagraph (B) applies, in lieu of para12 graph (4), in the case of a patent— 

13 ‘‘(i) that is identified, as applicable, in the list 

14 of patents described in section 351(l)(4) of the Pub15 lic Health Service Act or the lists of patents de16 scribed in section 351(l)(5)(B) of such Act with re17 spect to a biological product; and 

18 ‘‘(ii) for which an action for infringement of the 

19 patent with respect to the biological product— 

20 ‘‘(I) was brought after the expiration of 

21 the 30-day period described in subparagraph 

22 (A) or (B), as applicable, of section 351(l)(6) of 

23 such Act; or 

24 ‘‘(II) was brought before the expiration of 

25 the 30-day period described in subclause (I), 


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1 but which was dismissed without prejudice or 

2 was not prosecuted to judgment in good faith. 

3 ‘‘(B) In an action for infringement of a patent de4 scribed in subparagraph (A), the sole and exclusive remedy 

5 that may be granted by a court, upon a finding that the 

6 making, using, offering to sell, selling, or importation into 

7 the United States of the biological product that is the sub8 ject of the action infringed the patent, shall be a reason9 able royalty. 

10 ‘‘(C) The owner of a patent that should have been 

11 included in the list described in section 351(l)(3)(A) of 

12 the Public Health Service Act, including as provided under 

13 section 351(l)(7) of such Act for a biological product, but 

14 was not timely included in such list, may not bring an 

15 action under this section for infringement of the patent 

16 with respect to the biological product.’’. 

17 (2) CONFORMING AMENDMENT UNDER TITLE

18 28.—Section 2201(b) of title 28, United States 

19 Code, is amended by inserting before the period the 

20 following: ‘‘, or section 351 of the Public Health 

21 Service Act’’. 

22 (d) CONFORMING AMENDMENTS UNDER THE FED23 ERAL FOOD, DRUG, AND COSMETIC ACT.— 

24 (1) CONTENT AND REVIEW OF APPLICA25 TIONS.—Section 505(b)(5)(B) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is 

2 amended by inserting before the period at the end 

3 of the first sentence the following: ‘‘or, with respect 

4 to an applicant for approval of a biological product 

5 under section 351(k) of the Public Health Service 

6 Act, any necessary clinical study or studies’’. 

7 (2) NEW ACTIVE INGREDIENT.—Section 505B 

8 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355c) is amended by adding at the end the 

10 following: 

11 ‘‘(n) NEW ACTIVE INGREDIENT.— 

12 ‘‘(1) NON-INTERCHANGEABLE BIOSIMILAR BIO13 LOGICAL PRODUCT.—A biological product that is 

14 biosimilar to a reference product under section 351 

15 of the Public Health Service Act, and that the Sec16 retary has not determined to meet the standards de17 scribed in subsection (k)(4) of such section for inter18 changeability with the reference product, shall be 

19 considered to have a new active ingredient under 

20 this section. 

21 ‘‘(2) INTERCHANGEABLE BIOSIMILAR BIOLOGI22 CAL PRODUCT.—A biological product that is inter23 changeable with a reference product under section 

24 351 of the Public Health Service Act shall not be 


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1 considered to have a new active ingredient under 

2 this section.’’. 

3 (e) PRODUCTS PREVIOUSLY APPROVED UNDER SEC4 TION 505.— 

5 (1) REQUIREMENT TO FOLLOW SECTION 351.— 

6 Except as provided in paragraph (2), an application 

7 for a biological product shall be submitted under 

8 section 351 of the Public Health Service Act (42 

9 U.S.C. 262) (as amended by this Act). 

10 (2) EXCEPTION.—An application for a biologi11 cal product may be submitted under section 505 of 

12 the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 355) if— 

14 (A) such biological product is in a product 

15 class for which a biological product in such 

16 product class is the subject of an application 

17 approved under such section 505 not later than 

18 the date of enactment of this Act; and 

19 (B) such application— 

20 (i) has been submitted to the Sec21 retary of Health and Human Services (re22 ferred to in this subtitle as the ‘‘Sec23 retary’’) before the date of enactment of 

24 this Act; or 


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1 (ii) is submitted to the Secretary not 

2 later than the date that is 10 years after 

3 the date of enactment of this Act. 

4 (3) LIMITATION.—Notwithstanding paragraph 

5 (2), an application for a biological product may not 

6 be submitted under section 505 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355) if there is 

8 another biological product approved under sub9 section (a) of section 351 of the Public Health Serv10 ice Act that could be a reference product with re11 spect to such application (within the meaning of 

12 such section 351) if such application were submitted 

13 under subsection (k) of such section 351. 

14 (4) DEEMED APPROVED UNDER SECTION

15 351.—An approved application for a biological prod16 uct under section 505 of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 355) shall be deemed 

18 to be a license for the biological product under such 

19 section 351 on the date that is 10 years after the 

20 date of enactment of this Act. 

21 (5) DEFINITIONS.—For purposes of this sub22 section, the term ‘‘biological product’’ has the mean23 ing given such term under section 351 of the Public 

24 Health Service Act (42 U.S.C. 262) (as amended by 

25 this Act). 


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1 (f) FOLLOW-ON BIOLOGICS USER FEES.— 

2 (1) DEVELOPMENT OF USER FEES FOR BIO3 SIMILAR BIOLOGICAL PRODUCTS.— 

4 (A) IN GENERAL.—Beginning not later 

5 than October 1, 2010, the Secretary shall de6 velop recommendations to present to Congress 

7 with respect to the goals, and plans for meeting 

8 the goals, for the process for the review of bio9 similar biological product applications sub10 mitted under section 351(k) of the Public 

11 Health Service Act (as added by this Act) for 

12 the first 5 fiscal years after fiscal year 2012. In 

13 developing such recommendations, the Sec14 retary shall consult with— 

15 (i) the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate; 

17 (ii) the Committee on Energy and 

18 Commerce of the House of Representa19 tives; 

20 (iii) scientific and academic experts; 

21 (iv) health care professionals; 

22 (v) representatives of patient and con23 sumer advocacy groups; and 

24 (vi) the regulated industry. 


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1 (B) PUBLIC REVIEW OF RECOMMENDA2 TIONS.—After negotiations with the regulated 

3 industry, the Secretary shall— 

4 (i) present the recommendations de5 veloped under subparagraph (A) to the 

6 Congressional committees specified in such 

7 subparagraph; 

8 (ii) publish such recommendations in 

9 the Federal Register; 

10 (iii) provide for a period of 30 days 

11 for the public to provide written comments 

12 on such recommendations; 

13 (iv) hold a meeting at which the pub14 lic may present its views on such rec15 ommendations; and 

16 (v) after consideration of such public 

17 views and comments, revise such rec18 ommendations as necessary. 

19 (C) TRANSMITTAL OF RECOMMENDA20 TIONS.—Not later than January 15, 2012, the 

21 Secretary shall transmit to Congress the revised 

22 recommendations under subparagraph (B), a 

23 summary of the views and comments received 

24 under such subparagraph, and any changes 


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1 made to the recommendations in response to 

2 such views and comments. 

3 (2) ESTABLISHMENT OF USER FEE PRO4 GRAM.—It is the sense of the Senate that, based on 

5 the recommendations transmitted to Congress by the 

6 Secretary pursuant to paragraph (1)(C), Congress 

7 should authorize a program, effective on October 1, 

8 2012, for the collection of user fees relating to the 

9 submission of biosimilar biological product applica10 tions under section 351(k) of the Public Health 

11 Service Act (as added by this Act). 

12 (3) TRANSITIONAL PROVISIONS FOR USER FEES

13 FOR BIOSIMILAR BIOLOGICAL PRODUCTS.— 

14 (A) APPLICATION OF THE PRESCRIPTION

15 DRUG USER FEE PROVISIONS.—Section 

16 735(1)(B) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 379g(1)(B)) is amended 

18 by striking ‘‘section 351’’ and inserting ‘‘sub19 section (a) or (k) of section 351’’. 

20 (B) EVALUATION OF COSTS OF REVIEWING

21 BIOSIMILAR BIOLOGICAL PRODUCT APPLICA22 TIONS.—During the period beginning on the 

23 date of enactment of this Act and ending on 

24 October 1, 2010, the Secretary shall collect and 

25 evaluate data regarding the costs of reviewing 


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1 applications for biological products submitted 

2 under section 351(k) of the Public Health Serv3 ice Act (as added by this Act) during such pe4 riod. 

5 (C) AUDIT.— 

6 (i) IN GENERAL.—On the date that is 

7 2 years after first receiving a user fee ap8 plicable to an application for a biological 

9 product under section 351(k) of the Public 

10 Health Service Act (as added by this Act), 

11 and on a biennial basis thereafter until Oc12 tober 1, 2013, the Secretary shall perform 

13 an audit of the costs of reviewing such ap14 plications under such section 351(k). Such 

15 an audit shall compare— 

16 (I) the costs of reviewing such 

17 applications under such section 

18 351(k) to the amount of the user fee 

19 applicable to such applications; and 

20 (II)(aa) such ratio determined 

21 under subclause (I); to 

22 (bb) the ratio of the costs of re23 viewing applications for biological 

24 products under section 351(a) of such 

25 Act (as amended by this Act) to the 


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1 amount of the user fee applicable to 

2 such applications under such section 

3 351(a). 

4 (ii) ALTERATION OF USER FEE.—If 

5 the audit performed under clause (i) indi6 cates that the ratios compared under sub7 clause (II) of such clause differ by more 

8 than 5 percent, then the Secretary shall 

9 alter the user fee applicable to applications 

10 submitted under such section 351(k) to 

11 more appropriately account for the costs of 

12 reviewing such applications. 

13 (iii) ACCOUNTING STANDARDS.—The 

14 Secretary shall perform an audit under 

15 clause (i) in conformance with the account16 ing principles, standards, and requirements 

17 prescribed by the Comptroller General of 

18 the United States under section 3511 of 

19 title 31, United State Code, to ensure the 

20 validity of any potential variability. 

21 (4) AUTHORIZATION OF APPROPRIATIONS.— 

22 There is authorized to be appropriated to carry out 

23 this subsection such sums as may be necessary for 

24 each of fiscal years 2010 through 2012. 


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1 (g) ALLOCATION OF SAVINGS; SPECIAL RESERVE

2 FUND.— 

3 (1) DETERMINATION OF SAVINGS.—The Sec4 retary of the Treasury, in consultation with the Sec5 retary, shall for each fiscal year determine the 

6 amount of the savings to the Federal Government as 

7 a result of the enactment of this subtitle and shall 

8 transfer such amount to the Fund established under 

9 paragraph (2) pursuant to a relevant appropriations 

10 Act. 

11 (2) SPECIAL RESERVE FUND.— 

12 (A) IN GENERAL.—There is established in 

13 the Treasury of the United States a fund to be 

14 designated as the ‘‘Biological Product Savings 

15 Fund’’ to be made available to the Secretary 

16 without fiscal year limitation. 

17 (B) USE OF FUND.—The amounts made 

18 available to the Secretary through the Fund 

19 under subparagraph (A) shall be expended on 

20 activities authorized under the Public Health 

21 Service Act. 

22 (3) AUTHORIZATION OF APPROPRIATIONS.— 

23 There is authorized to be appropriated for each fis24 cal year to the Fund established under paragraph 


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1 (2), the amount of the savings determined for such 

2 fiscal year under paragraph (1). 

3 (h) GOVERNMENT ACCOUNTABILITY OFFICE

4 STUDY.— 

5 (1) IN GENERAL.—Not later than 3 years after 

6 the date of enactment of this Act, the Comptroller 

7 General of the United States shall study and report 

8 to Congress regarding— 

9 (A) the extent to which pediatric studies of 

10 biological products are being required under the 

11 Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 301 et seq.); and 

13 (B) any pediatric needs not being met 

14 under existing authority. 

15 (2) CONTENT OF STUDY.—The study under 

16 paragraph (1) shall review and assess— 

17 (A) the extent to which pediatric studies of 

18 biological products are required under sub19 sections (a) and (b) of section 505B of the Fed20 eral Food, Drug and Cosmetic Act (21 U.S.C. 

21 355c); 

22 (B) the extent to which pediatric studies of 

23 biological products are required as part of risk 

24 evaluation and mitigation strategies under such 

25 Act; 


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1 (C) the number, importance, and 

2 prioritization of any biological products that are 

3 not being tested for pediatric use; and 

4 (D) recommendations for ensuring pedi5 atric testing of products identified in subpara6 graph (C), including the consideration of any 

7 incentives, such as those provided under the 

8 Best Pharmaceuticals for Children Act. 

9 (i) ORPHAN PRODUCTS.—If a reference product, as 

10 defined in section 351 of the Public Health Service Act 

11 (42 U.S.C. 262) (as amended by this Act) has been des12 ignated under section 526 of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 360bb) for a rare disease or con14 dition, a biological product seeking approval for such dis15 ease or condition under subsection (k) of such section 351 

16 as biosimilar to, or interchangeable with, such reference 

17 product may be licensed by the Secretary only after the 

18 expiration for such reference product of the later of— 

19 (1) the 7-year period described in section 

20 527(a) of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 360cc(a)); and 

22 (2) the 12-year period described in subsection 

23 (k)(7) of such section 351. 


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1 SEC. 603. SAVINGS. 

2 (a) DETERMINATION.—The Secretary of the Treas3 ury, in consultation with the Secretary of Health and 

4 Human Services, shall for each fiscal year determine the 

5 amount of savings to the Federal Government as a result 

6 of the enactment of this subtitle. 

7 (b) USE.—Notwithstanding any other provision of 

8 this subtitle (or an amendment made by this subtitle), the 

9 savings to the Federal Government generated as a result 

10 of the enactment of this subtitle shall be used for deficit 

11 reduction. 

12 Subtitle B—More Affordable Medi13 cines for Children and Under14 served Communities 

15 SEC. 611. EXPANDED PARTICIPATION IN 340B PROGRAM. 

16 (a) EXPANSION OF COVERED ENTITIES RECEIVING

17 DISCOUNTED PRICES.—Section 340B(a)(4) of the Public 

18 Health Service Act (42 U.S.C. 256b(a)(4)) is amended by 

19 adding at the end the following: 

20 ‘‘(M) A children’s hospital excluded from 

21 the Medicare prospective payment system pur22 suant to section 1886(d)(1)(B)(iii) of the Social 

23 Security Act, or a free-standing cancer hospital 

24 excluded from the Medicare prospective pay25 ment system pursuant to section 

26 1886(d)(1)(B)(v) of the Social Security Act, 


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1 that would meet the requirements of subpara2 graph (L), including the disproportionate share 

3 adjustment percentage requirement under 

4 clause (ii) of such subparagraph, if the hospital 

5 were a subsection (d) hospital as defined by sec6 tion 1886(d)(1)(B) of the Social Security Act. 

7 ‘‘(N) An entity that is a critical access hos8 pital (as determined under section 1820(c)(2) 

9 of the Social Security Act), and that meets the 

10 requirements of subparagraph (L)(i). 

11 ‘‘(O) An entity that is a rural referral cen12 ter, as defined by section 1886(d)(5)(C)(i) of 

13 the Social Security Act, or a sole community 

14 hospital, as defined by section 

15 1886(d)(5)(C)(iii) of such Act, and that both 

16 meets the requirements of subparagraph (L)(i) 

17 and has a disproportionate share adjustment 

18 percentage equal to or greater than 8 percent.’’. 

19 (b) EXTENSION OF DISCOUNT TO INPATIENT

20 DRUGS.—Section 340B of the Public Health Service Act 

21 (42 U.S.C. 256b) is amended— 

22 (1) in paragraphs (2), (5), (7), and (9) of sub23 section (a), by striking ‘‘outpatient’’ each place it 

24 appears; and 

25 (2) in subsection (b)— 


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1 (A) by striking ‘‘OTHER DEFINITION’’ and 

2 all that follows through ‘‘In this section’’ and 

3 inserting the following: ‘‘OTHER DEFINI4 TIONS.— 

5 ‘‘(1) IN GENERAL.—In this section’’; and 

6 (B) by adding at the end the following new 

7 paragraph: 

8 ‘‘(2) COVERED DRUG.—In this section, the term 

9 ‘covered drug’— 

10 ‘‘(A) means a covered outpatient drug (as 

11 defined in section 1927(k)(2) of the Social Se12 curity Act); and 

13 ‘‘(B) includes, notwithstanding paragraph 

14 (3)(A) of section 1927(k) of such Act, a drug 

15 used in connection with an inpatient or out16 patient service provided by a hospital described 

17 in subparagraph (L), (M), (N), or (O) of sub18 section (a)(4) that is enrolled to participate in 

19 the drug discount program under this section.’’. 

20 (c) PROHIBITION ON GROUP PURCHASING ARRANGE21 MENTS.—Section 340B(a) of the Public Health Service 

22 Act (42 U.S.C. 256b(a)) is amended— 

23 (1) in paragraph (4)(L)— 

24 (A) in clause (i), by adding ‘‘and’’ at the 

25 end; 


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1 (B) in clause (ii), by striking ‘‘; and’’ and 

2 inserting a period; and 

3 (C) by striking clause (iii); and 

4 (2) in paragraph (5), as amended by subsection 

5 (b)— 

6 (A) by redesignating subparagraphs (C) 

7 and (D) as subparagraphs (D) and (E); respec8 tively; and 

9 (B) by inserting after subparagraph (B), 

10 the following: 

11 ‘‘(C) PROHIBITION ON GROUP PURCHASING

12 ARRANGEMENTS.— 

13 ‘‘(i) IN GENERAL.—A hospital de14 scribed in subparagraph (L), (M), (N), or 

15 (O) of paragraph (4) shall not obtain cov16 ered outpatient drugs through a group 

17 purchasing organization or other group 

18 purchasing arrangement, except as per19 mitted or provided for pursuant to clauses 

20 (ii) or (iii). 

21 ‘‘(ii) INPATIENT DRUGS.—Clause (i) 

22 shall not apply to drugs purchased for in23 patient use. 


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1 ‘‘(iii) EXCEPTIONS.—The Secretary 

2 shall establish reasonable exceptions to 

3 clause (i)— 

4 ‘‘(I) with respect to a covered 

5 outpatient drug that is unavailable to 

6 be purchased through the program 

7 under this section due to a drug 

8 shortage problem, manufacturer non9 compliance, or any other circumstance 

10 beyond the hospital’s control; 

11 ‘‘(II) to facilitate generic substi12 tution when a generic covered out13 patient drug is available at a lower 

14 price; or 

15 ‘‘(III) to reduce in other ways 

16 the administrative burdens of man17 aging both inventories of drugs sub18 ject to this section and inventories of 

19 drugs that are not subject to this sec20 tion, so long as the exceptions do not 

21 create a duplicate discount problem in 

22 violation of subparagraph (A) or a di23 version problem in violation of sub24 paragraph (B). 


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1 ‘‘(iv) PURCHASING ARRANGEMENTS

2 FOR INPATIENT DRUGS.—The Secretary 

3 shall ensure that a hospital described in 

4 subparagraph (L), (M), (N), or (O) of sub5 section (a)(4) that is enrolled to partici6 pate in the drug discount program under 

7 this section shall have multiple options for 

8 purchasing covered drugs for inpatients, 

9 including by utilizing a group purchasing 

10 organization or other group purchasing ar11 rangement, establishing and utilizing its 

12 own group purchasing program, pur13 chasing directly from a manufacturer, and 

14 any other purchasing arrangements that 

15 the Secretary determines is appropriate to 

16 ensure access to drug discount pricing 

17 under this section for inpatient drugs tak18 ing into account the particular needs of 

19 small and rural hospitals.’’. 

20 (d) MEDICAID CREDITS ON INPATIENT DRUGS.— 

21 Section 340B of the Public Health Service Act (42 U.S.C. 

22 256b) is amended by striking subsection (c) and inserting 

23 the following: 

24 ‘‘(c) MEDICAID CREDIT.—Not later than 90 days 

25 after the date of filing of the hospital’s most recently filed 


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1 Medicare cost report, the hospital shall issue a credit as 

2 determined by the Secretary to the State Medicaid pro3 gram for inpatient covered drugs provided to Medicaid re4 cipients.’’. 

5 (e) EFFECTIVE DATES.— 

6 (1) IN GENERAL.—The amendments made by 

7 this section and section 612 shall take effect on Jan8 uary 1, 2010, and shall apply to drugs purchased on 

9 or after January 1, 2010. 

10 (2) EFFECTIVENESS.—The amendments made 

11 by this section and section 612 shall be effective and 

12 shall be taken into account in determining whether 

13 a manufacturer is deemed to meet the requirements 

14 of section 340B(a) of the Public Health Service Act 

15 (42 U.S.C. 256b(a)), notwithstanding any other pro16 vision of law. 

17 SEC. 612. IMPROVEMENTS TO 340B PROGRAM INTEGRITY. 

18 (a) INTEGRITY IMPROVEMENTS.—Subsection (d) of 

19 section 340B of the Public Health Service Act (42 U.S.C. 

20 256b) is amended to read as follows: 

21 ‘‘(d) IMPROVEMENTS IN PROGRAM INTEGRITY.— 

22 ‘‘(1) MANUFACTURER COMPLIANCE.— 

23 ‘‘(A) IN GENERAL.—From amounts appro24 priated under paragraph (4), the Secretary 

25 shall provide for improvements in compliance by 


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1 manufacturers with the requirements of this 

2 section in order to prevent overcharges and 

3 other violations of the discounted pricing re4 quirements specified in this section. 

5 ‘‘(B) IMPROVEMENTS.—The improvements 

6 described in subparagraph (A) shall include the 

7 following: 

8 ‘‘(i) The development of a system to 

9 enable the Secretary to verify the accuracy 

10 of ceiling prices calculated by manufactur11 ers under subsection (a)(1) and charged to 

12 covered entities, which shall include the 

13 following: 

14 ‘‘(I) Developing and publishing 

15 through an appropriate policy or regu16 latory issuance, precisely defined 

17 standards and methodology for the 

18 calculation of ceiling prices under 

19 such subsection. 

20 ‘‘(II) Comparing regularly the 

21 ceiling prices calculated by the Sec22 retary with the quarterly pricing data 

23 that is reported by manufacturers to 

24 the Secretary. 


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1 ‘‘(III) Performing spot checks of 

2 sales transactions by covered entities. 

3 ‘‘(IV) Inquiring into the cause of 

4 any pricing discrepancies that may be 

5 identified and either taking, or requir6 ing manufacturers to take, such cor7 rective action as is appropriate in re8 sponse to such price discrepancies. 

9 ‘‘(ii) The establishment of procedures 

10 for manufacturers to issue refunds to cov11 ered entities in the event that there is an 

12 overcharge by the manufacturers, including 

13 the following: 

14 ‘‘(I) Providing the Secretary with 

15 an explanation of why and how the 

16 overcharge occurred, how the refunds 

17 will be calculated, and to whom the 

18 refunds will be issued. 

19 ‘‘(II) Oversight by the Secretary 

20 to ensure that the refunds are issued 

21 accurately and within a reasonable pe22 riod of time, both in routine instances 

23 of retroactive adjustment to relevant 

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1 tentional overcharging for covered 

2 drugs. 

3 ‘‘(iii) The provision of access through 

4 the Internet website of the Department of 

5 Health and Human Services to the applica6 ble ceiling prices for covered drugs as cal7 culated and verified by the Secretary in ac8 cordance with this section, in a manner 

9 (such as through the use of password pro10 tection) that limits such access to covered 

11 entities and adequately assures security 

12 and protection of privileged pricing data 

13 from unauthorized re-disclosure. 

14 ‘‘(iv) The development of a mecha15 nism by which— 

16 ‘‘(I) rebates and other discounts 

17 provided by manufacturers to other 

18 purchasers subsequent to the sale of 

19 covered drugs to covered entities are 

20 reported to the Secretary; and 

21 ‘‘(II) appropriate credits and re22 funds are issued to covered entities if 

23 such discounts or rebates have the ef24 fect of lowering the applicable ceiling 


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1 price for the relevant quarter for the 

2 drugs involved. 

3 ‘‘(v) Selective auditing of manufactur4 ers and wholesalers to ensure the integrity 

5 of the drug discount program under this 

6 section. 

7 ‘‘(vi) The imposition of sanctions in 

8 the form of civil monetary penalties, 

9 which— 

10 ‘‘(I) shall be assessed according 

11 to standards established in regulations 

12 to be promulgated by the Secretary 

13 not later than 180 days after the date 

14 of enactment of Affordable Health 

15 Choices Act; 

16 ‘‘(II) shall not exceed $5,000 for 

17 each instance of overcharging a cov18 ered entity that may have occurred; 

19 and 

20 ‘‘(III) shall apply to any manu21 facturer with an agreement under this 

22 section that knowingly and inten23 tionally charges a covered entity a 

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1 ceeds the maximum applicable price 

2 under subsection (a)(1). 

3 ‘‘(2) COVERED ENTITY COMPLIANCE.— 

4 ‘‘(A) IN GENERAL.—From amounts appro5 priated under paragraph (4), the Secretary 

6 shall provide for improvements in compliance by 

7 covered entities with the requirements of this 

8 section in order to prevent diversion and viola9 tions of the duplicate discount provision and 

10 other requirements specified under subsection 

11 (a)(5). 

12 ‘‘(B) IMPROVEMENTS.—The improvements 

13 described in subparagraph (A) shall include the 

14 following: 

15 ‘‘(i) The development of procedures to 

16 enable and require covered entities to regu17 larly update (at least annually) the infor18 mation on the Internet website of the De19 partment of Health and Human Services 

20 relating to this section. 

21 ‘‘(ii) The development of a system for 

22 the Secretary to verify the accuracy of in23 formation regarding covered entities that is 

24 listed on the website described in clause 

25 (i). 


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1 ‘‘(iii) The development of more de2 tailed guidance describing methodologies 

3 and options available to covered entities for 

4 billing covered drugs to State Medicaid 

5 agencies in a manner that avoids duplicate 

6 discounts pursuant to subsection (a)(5)(A). 

7 ‘‘(iv) The establishment of a single, 

8 universal, and standardized identification 

9 system by which each covered entity site 

10 can be identified by manufacturers, dis11 tributors, covered entities, and the Sec12 retary for purposes of facilitating the or13 dering, purchasing, and delivery of covered 

14 drugs under this section, including the 

15 processing of chargebacks for such drugs. 

16 ‘‘(v) The imposition of sanctions, in 

17 appropriate cases as determined by the 

18 Secretary, additional to those to which cov19 ered entities are subject under subpara20 graph (a)(5)(E), through one or more of 

21 the following actions: 

22 ‘‘(I) Where a covered entity 

23 knowingly and intentionally violates 

24 subparagraph (a)(5)(B), the covered 

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1 etary penalty to a manufacturer or 

2 manufacturers in the form of interest 

3 on sums for which the covered entity 

4 is found liable under paragraph 

5 (a)(5)(E), such interest to be com6 pounded monthly and equal to the 

7 current short term interest rate as de8 termined by the Federal Reserve for 

9 the time period for which the covered 

10 entity is liable. 

11 ‘‘(II) Where the Secretary deter12 mines a violation of subparagraph 

13 (a)(5)(B) was systematic and egre14 gious as well as knowing and inten15 tional, removing the covered entity 

16 from the drug discount program 

17 under this section and disqualifying 

18 the entity from re-entry into such pro19 gram for a reasonable period of time 

20 to be determined by the Secretary. 

21 ‘‘(III) Referring matters to ap22 propriate Federal authorities within 

23 the Food and Drug Administration, 

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1 ices, or other Federal agencies for 

2 consideration of appropriate action 

3 under other Federal statutes, such as 

4 the Prescription Drug Marketing Act 

5 (21 U.S.C. 353). 

6 ‘‘(3) ADMINISTRATIVE DISPUTE RESOLUTION

7 PROCESS.— 

8 ‘‘(A) IN GENERAL.—Not later than 180 

9 days after the date of enactment of Affordable 

10 Health Choices Act, the Secretary shall promul11 gate regulations to establish and implement an 

12 administrative process for the resolution of 

13 claims by covered entities that they have been 

14 overcharged for drugs purchased under this sec15 tion, and claims by manufacturers, after the 

16 conduct of audits as authorized by subsection 

17 (a)(5)(D), of violations of subsections (a)(5)(A) 

18 or (a)(5)(B), including appropriate procedures 

19 for the provision of remedies and enforcement 

20 of determinations made pursuant to such proc21 ess through mechanisms and sanctions de22 scribed in paragraphs (1)(B) and (2)(B). 

23 ‘‘(B) DEADLINES AND PROCEDURES.— 

24 Regulations promulgated by the Secretary 

25 under subparagraph (A) shall— 


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1 ‘‘(i) designate or establish a decision2 making official or decision-making body 

3 within the Department of Health and 

4 Human Services to be responsible for re5 viewing and finally resolving claims by cov6 ered entities that they have been charged 

7 prices for covered drugs in excess of the 

8 ceiling price described in subsection (a)(1), 

9 and claims by manufacturers that viola10 tions of subsection (a)(5)(A) or (a)(5)(B) 

11 have occurred; 

12 ‘‘(ii) establish such deadlines and pro13 cedures as may be necessary to ensure that 

14 claims shall be resolved fairly, efficiently, 

15 and expeditiously; 

16 ‘‘(iii) establish procedures by which a 

17 covered entity may discover and obtain 

18 such information and documents from 

19 manufacturers and third parties as may be 

20 relevant to demonstrate the merits of a 

21 claim that charges for a manufacturer’s 

22 product have exceeded the applicable ceil23 ing price under this section, and may sub24 mit such documents and information to the 


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1 administrative official or body responsible 

2 for adjudicating such claim; 

3 ‘‘(iv) require that a manufacturer con4 duct an audit of a covered entity pursuant 

5 to subsection (a)(5)(D) as a prerequisite to 

6 initiating administrative dispute resolution 

7 proceedings against a covered entity; 

8 ‘‘(v) permit the official or body des9 ignated under clause (i), at the request of 

10 a manufacturer or manufacturers, to con11 solidate claims brought by more than one 

12 manufacturer against the same covered en13 tity where, in the judgment of such official 

14 or body, consolidation is appropriate and 

15 consistent with the goals of fairness and 

16 economy of resources; and 

17 ‘‘(vi) include provisions and proce18 dures to permit multiple covered entities to 

19 jointly assert claims of overcharges by the 

20 same manufacturer for the same drug or 

21 drugs in one administrative proceeding, 

22 and permit such claims to be asserted on 

23 behalf of covered entities by associations or 

24 organizations representing the interests of 


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1 such covered entities and of which the cov2 ered entities are members. 

3 ‘‘(C) FINALITY OF ADMINISTRATIVE RESO4 LUTION.—The administrative resolution of a 

5 claim or claims under the regulations promul6 gated under subparagraph (A) shall be a final 

7 agency decision and shall be binding upon the 

8 parties involved, unless invalidated by an order 

9 of a court of competent jurisdiction. 

10 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

11 There are authorized to be appropriated to carry out 

12 this subsection, such sums as may be necessary for 

13 fiscal year 2010 and each succeeding fiscal year.’’. 

14 (b) CONFORMING AMENDMENTS.—Section 340B(a) 

15 of the Public Health Service Act (42 U.S.C. 256b(a)) is 

16 amended— 

17 (1) in subsection (a)(1), by adding at the end 

18 the following: ‘‘Each such agreement shall require 

19 that the manufacturer furnish the Secretary with re20 ports, on a quarterly basis, of the price for each cov21 ered drug subject to the agreement that, according 

22 to the manufacturer, represents the maximum price 

23 that covered entities may permissibly be required to 

24 pay for the drug (referred to in this section as the 

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1 turer offer each covered entity covered drugs for 

2 purchase at or below the applicable ceiling price if 

3 such drug is made available to any other purchaser 

4 at any price.’’; and 

5 (2) in the first sentence of subsection (a)(5)(E), 

6 as redesignated by section 611(c), by inserting 

7 ‘‘after audit as described in subparagraph (D) and’’ 

8 after ‘‘finds,’’. 

9 SEC. 613. GAO STUDY TO MAKE RECOMMENDATIONS ON IM10 PROVING THE 340B PROGRAM. 

11 (a) REPORT.—Not later than 18 months after the 

12 date of enactment of this Act, the Comptroller General 

13 of the United States shall submit to Congress a report 

14 that examines whether those individuals served by the cov15 ered entities under the program under section 340B of 

16 the Public Health Service Act (42 U.S.C. 256b) (referred 

17 to in this section as the ‘‘340B program’’) are receiving 

18 optimal health care services. 

19 (b) RECOMMENDATIONS.—The report under sub20 section (a) shall include recommendations on the fol21 lowing: 

22 (1) Whether the 340B program should be ex23 panded since it is anticipated that the 47,000,000 

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1 actment of this Act will have health care coverage 

2 once this Act is implemented. 

3 (2) Whether mandatory sales of certain prod4 ucts by the 340B program could hinder patients ac5 cess to those therapies through any provider. 

6 (3) Whether income from the 340B program is 

7 being used by the covered entities under the pro8 gram to further the program objectives. 


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Calendar No. 161 

111TH CONGRESS 

1ST SESSION S. 1679 

A BILL 

To make quality, affordable health care available to 

strengthen the health care workforce. quality, enhance disease prevention, and all Americans, reduce costs, improve health care 

SEPTEMBER 17, 2009 

Read twice and placed on the calendar 


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