II 

116TH CONGRESS 

1ST SESSION S. 1895 

To lower health care costs. 

IN THE SENATE OF THE UNITED STATES 

JUNE 19, 2019 

Mr. ALEXANDER (for himself and Mrs. MURRAY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To lower health care costs. 

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 ‘‘Lower Health Care Costs Act’’. 

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—ENDING SURPRISE MEDICAL BILLS 

Sec. 101. Protecting patients against out-of-network deductibles in emergencies. 

Sec. 102. Protection against surprise bills. 

Sec. 103. Benchmark for payment. 

Sec. 104. Effective date. 

Sec. 105. Ending surprise air ambulance bills. 


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Sec. 106. Report. 

TITLE II—REDUCING THE PRICES OF PRESCRIPTION DRUGS 

Sec. 201. Biological product patent transparency. 

Sec. 202. Orange book modernization. 

Sec. 203. Ensuring timely access to generics. 

Sec. 204. Protecting access to biological products. 

Sec. 205. Preventing blocking of generic drugs. 

Sec. 206. Education on biological products. 

Sec. 207. Biological product innovation. 

Sec. 208. Clarifying the meaning of new chemical entity. 

Sec. 209. Streamlining the transition of biological products. 

Sec. 210. Orphan drug clarification. 

Sec. 211. Prompt approval of drugs related to safety information. 

Sec. 212. Conditions of use for biosimilar biological products. 

Sec. 213. Modernizing the labeling of certain generic drugs. 

TITLE III—IMPROVING TRANSPARENCY IN HEALTH CARE 

Sec. 301. Increasing transparency by removing gag clauses on price and quality 

information. 

Sec. 302. Banning anticompetitive terms in facility and insurance contracts 

that limit access to higher quality, lower cost care. 

Sec. 303. Designation of a nongovernmental, nonprofit transparency organization to lower Americans’ health care costs. 

Sec. 304. Protecting patients and improving the accuracy of provider directory 

information. 

Sec. 305. Timely bills for patients. 

Sec. 306. Health plan oversight of pharmacy benefit manager services. 

Sec. 307. Government Accountability Office study on profit- and revenue-sharing in health care. 

Sec. 308. Disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in 

plans on the individual market. 

Sec. 309. Ensuring enrollee access to cost-sharing information. 

Sec. 310. Strengthening parity in mental health and substance use disorder 

benefits. 

Sec. 311. Technical amendments. 

Sec. 312. Third-party administrators. 

TITLE IV—IMPROVING PUBLIC HEALTH 

Sec. 401. Improving awareness of disease prevention. 

Sec. 402. Grants to address vaccine-preventable diseases. 

Sec. 403. Guide on evidence-based strategies for public health department obesity prevention programs. 

Sec. 404. Expanding capacity for health outcomes. 

Sec. 405. Public health data system modernization. 

Sec. 406. Innovation for maternal health. 

Sec. 407. Training for health care providers. 

Sec. 408. Study on training to reduce and prevent discrimination. 

Sec. 409. Perinatal quality collaboratives. 

Sec. 410. Integrated services for pregnant and postpartum women. 


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Sec. 411. Extension for community health centers, the National Health Service 

Corps, and teaching health centers that operate GME programs. 

Sec. 412. Other programs. 

TITLE V—IMPROVING THE EXCHANGE OF HEALTH 

INFORMATION 

Sec. 501. Requirement to provide health claims, network, and cost information. 

Sec. 502. Recognition of security practices. 

Sec. 503. GAO study on the privacy and security risks of electronic transmission of individually identifiable health information to and 

from entities not covered by the Health Insurance Portability 

and Accountability Act. 

Sec. 504. Technical corrections. 

1 TITLE I—ENDING SURPRISE 

2 MEDICAL BILLS 

3 SEC. 101. PROTECTING PATIENTS AGAINST OUT-OF-NET4 WORK DEDUCTIBLES IN EMERGENCIES. 

5 Section 2719A(b) of the Public Health Service Act 

6 (42 U.S.C. 300gg–19a) is amended— 

7 (1) in paragraph (1)— 

8 (A) in the matter preceding subparagraph 

9 (A), by inserting ‘‘or a freestanding emergency 

10 room’’ after ‘‘hospital’’; and 

11 (B) in subparagraph (C)— 

12 (i) in clause (ii)(I), by inserting ‘‘or 

13 emergency room’’ after ‘‘emergency depart14 ment’’; and 

15 (ii) in subparagraph (C)(ii)(II), by 

16 adding, ‘‘a deductible,’’ after ‘‘(expressed 

17 as’’; and 

18 (2) in paragraph (2)(B)— 


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1 (A) in clause (i)— 

2 (i) by inserting ‘‘or freestanding emer3 gency room’’ after ‘‘hospital’’; and 

4 (ii) by inserting ‘‘or emergency room’’ 

5 after ‘‘emergency department’’; and 

6 (B) in clause (ii), by inserting ‘‘or emer7 gency room’’ after ‘‘hospital’’. 

8 SEC. 102. PROTECTION AGAINST SURPRISE BILLS. 

9 (a) PHSA.—Section 2719A of the Public Health 

10 Service Act (42 U.S.C. 300gg–19a) is amended by adding 

11 at the end the following: 

12 ‘‘(e) COVERAGE OF CERTAIN OUT-OF-NETWORK

13 SERVICES.— 

14 ‘‘(1) IN GENERAL.—Subject to subsection (h), 

15 in the case of an enrollee in a group health plan or 

16 group or individual health insurance coverage who 

17 receives out-of-network, ancillary, non-emergency 

18 services at an in-network facility, including any re19 ferrals for diagnostic services— 

20 ‘‘(A) the cost-sharing requirement (ex21 pressed as a copayment amount, coinsurance 

22 rate, or deductible) with respect to such services 

23 shall be the same requirement that would apply 

24 if such services were provided by an in-network 


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1 practitioner, and any coinsurance or deductible 

2 shall be based on in-network rates; and 

3 ‘‘(B) such cost-sharing amounts shall be 

4 counted towards the in-network deductible and 

5 in-network out-of-pocket maximum amount 

6 under the plan or coverage for the plan year. 

7 ‘‘(2) DEFINITION.—For purposes of this sub8 section, the term ‘facility’ has the meaning given the 

9 term ‘health care facility’ in section 2729A(c). 

10 ‘‘(f) COVERAGE OF OUT-OF-NETWORK SERVICES FOR

11 ENROLLEES ADMITTED AFTER EMERGENCY SERVICES.— 

12 ‘‘(1) NOTICE AND CONSENT.—Subject to sub13 section (h), in the case of an enrollee in a group 

14 health plan or group or individual health insurance 

15 coverage who receives emergency services, or mater16 nal care for a woman in labor, in the emergency de17 partment of an out-of-network facility and has been 

18 stabilized (within the meaning of subsection 

19 (b)(2)(C)), if the patient is subsequently admitted to 

20 the out-of-network facility for care, the cost-sharing 

21 requirement (expressed as a copayment amount, co22 insurance rate, or deductible) with respect to any 

23 out-of-network services is the same requirement that 

24 would apply if such services were provided by a par25 ticipating provider, unless the enrollee, once stable 


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1 and in a condition to receive such information, in2 cluding having sufficient mental capacity— 

3 ‘‘(A) has been provided by the facility, 

4 prior to the provision of any post-stabilization, 

5 out-of-network service at such facility, with— 

6 ‘‘(i) paper and electronic notification 

7 that the practitioner or facility is an out8 of-network health care provider and the 

9 out-of-network rate of the provider, as ap10 plicable, and the option to affirmatively 

11 consent to receiving services from such 

12 practitioner or facility; and 

13 ‘‘(ii) the estimated amount that such 

14 provider may charge the participant, bene15 ficiary, or enrollee for such items and serv16 ices involved; 

17 ‘‘(B) has been provided by the plan or cov18 erage, prior to the provision of any post-sta19 bilization, out-of-network service at such facil20 ity, with— 

21 ‘‘(i) paper and electronic notification 

22 that the practitioner or facility is an out23 of-network health care provider and the 

24 out-of-network rate of the provider, as ap25 plicable, and the option to affirmatively 


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1 consent to receiving services from such 

2 practitioner or facility; 

3 ‘‘(ii) a list of in-network practitioners 

4 or facilities that could provide the same 

5 services, and an option for a referral to 

6 such providers; and 

7 ‘‘(iii) information about whether prior 

8 authorization or other care management 

9 limitations may be required in advance of 

10 receiving in-network care at the facility; 

11 and 

12 ‘‘(C) has acknowledged that the out-of-net13 work treatment may not be covered or may be 

14 covered at an out-of-network cost-sharing 

15 amount, requiring higher cost-sharing obliga16 tions of the enrollee than if the service were 

17 provided at an in-network facility, and has as18 sumed, in writing, full responsibility of out-of19 pocket costs associated with services furnished 

20 after the enrollee has been stabilized, from the 

21 out-of-network practitioner or facility, as appli22 cable. 

23 ‘‘(2) REQUIREMENTS OF NOTICE.—The notice 

24 under paragraph (1) shall be in a format determined 

25 by the Secretary to give a reasonable layperson clear 


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1 comprehension of the terms of the agreement, in2 cluding all possible financial responsibilities, includ3 ing the requirements that the notice— 

4 ‘‘(A) does not exceed one page in length; 

5 ‘‘(B) is readily identifiable for its purpose 

6 and as a contract of consent; 

7 ‘‘(C) clearly states that consent is optional; 

8 ‘‘(D) includes an estimate of the amount 

9 that such provider will charge the participant, 

10 beneficiary, or enrollee for such items and serv11 ices involved; and 

12 ‘‘(E) be available in the 15 most common 

13 languages in the facility’s geographic area, with 

14 the facility making a good faith effort to pro15 vide oral notice in the enrollee’s primary lan16 guage if it is not one of such 15 languages. 

17 ‘‘(g) PROHIBITION ON BILLING MORE THAN AN IN18 NETWORK RATE UNDER CERTAIN CIRCUMSTANCES.— 

19 ‘‘(1) IN GENERAL.—A facility or practitioner 

20 furnishing— 

21 ‘‘(A) emergency services, as defined in sub22 section (b)(2), regardless of the State in which 

23 the patient resides; 

24 ‘‘(B) services at an in-network facility de25 scribed in subsection (e); or 


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1 ‘‘(C) out-of-network services furnished 

2 after the enrollee has been stabilized (within the 

3 meaning of subsection (b)(2)(C)), where the no4 tice and option for referral required under sub5 section (f)(1) have not been provided to the en6 rollee and the assumption of responsibility for 

7 out-of-pocket costs under subsection (f)(2) has 

8 not been obtained, 

9 may not bill an enrollee in a group health plan or 

10 group or individual health insurance coverage for 

11 amounts beyond the cost-sharing amount that would 

12 apply under subsection (b)(1)(C)(ii)(II), (e), or (f), 

13 as applicable. 

14 ‘‘(2) NOTICE.—A facility furnishing services de15 scribed in paragraph (1) shall provide enrollees in a 

16 group health plan or group or individual health in17 surance coverage with a one-page notice, in 16-point 

18 font, upon intake at the emergency room or being 

19 admitted at the facility of the prohibition on balance 

20 billing under paragraph (1) and who to contact for 

21 recourse if they are sent a balance bill in violation 

22 of such paragraph. The facility shall be responsible 

23 for obtaining the signature from the enrollee on such 

24 notice. The Secretary shall issue regulations within 

25 6 months of the date of enactment of the Lower 


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1 Health Care Costs Act on the requirements for the 

2 notice under this paragraph. 

3 ‘‘(3) ENFORCEMENT.— 

4 ‘‘(A) IN GENERAL.—Subject to subpara5 graph (B), a facility or practitioner that vio6 lates a requirement under paragraph (1) shall 

7 be subject to a civil monetary penalty of not 

8 more than $10,000 for each act constituting 

9 such violation. 

10 ‘‘(B) PROCEDURE.—The provisions of sec11 tion 1128A of the Social Security Act, other 

12 than subsections (a) and (b) and the first sen13 tence of subsection (c)(1) of such section, shall 

14 apply to civil money penalties under this sub15 section in the same manner as such provisions 

16 apply to a penalty or proceeding under section 

17 1128A of the Social Security Act. 

18 ‘‘(C) SAFE HARBOR.—The Secretary shall 

19 waive the penalties described under subpara20 graph (A) with respect to a facility or, practi21 tioner who unknowingly violates paragraph (1) 

22 with respect to an enrollee, if such facility or 

23 practitioner, within 30 days of the violation, 

24 withdraws the bill that was in violation of para25 graph (1), and, as applicable, reimburses the 


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1 group health plan, health insurance issuer, or 

2 enrollee, as applicable, in an amount equal to 

3 the amount billed in violation of paragraph (1), 

4 plus interest, at an interest rate determined by 

5 the Secretary. 

6 ‘‘(h) MAINTAINING STATE SURPRISE BILLING PRO7 TECTIONS.— 

8 ‘‘(1) IN GENERAL.—Notwithstanding section 

9 514 of the Employee Retirement Income Security 

10 Act of 1974, except with respect to self-insured 

11 group health plans, nothing in this section shall pre12 vent a State from establishing or continuing in effect 

13 an alternate method under State law for determining 

14 the appropriate compensation for services described 

15 in subsection (b), (e), or (f). 

16 ‘‘(2) ADDITIONAL APPLICATION.—In the case of 

17 group health plans or health insurance coverage in 

18 the individual or group market offered in a State 

19 that has not enacted an alternate method described 

20 in paragraph (1), such as arbitration or a bench21 mark, or for services described in subsection (b), (e), 

22 or (f) that are not covered by such State’s alternate 

23 method described in paragraph (1), the provisions of 

24 this section shall apply. 


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1 ‘‘(3) SELF-INSURED PLANS.—Subsections (b), 

2 (e), and (f) shall apply to a self-insured group health 

3 plan that is not subject to State insurance regula4 tion.’’. 

5 (b) COVERAGE UNDER FEDERAL EMPLOYEES

6 HEALTH BENEFITS PROGRAM.—Section 8904 of title 5, 

7 United States Code, is amended by adding at the end the 

8 following: 

9 ‘‘(c) Any health benefits plan offered under this chap10 ter shall be treated as a group health plan or group or 

11 individual health insurance coverage for purposes of sub12 sections (e) through (g) of section 2719A of the Public 

13 Health Service Act (42 U.S.C. 300gg–19a) (except for 

14 paragraph (3) of such subsection (g)).’’. 

15 SEC. 103. BENCHMARK FOR PAYMENT. 

16 (a) IN GENERAL.—Subpart II of part A of title 

17 XXVII of the Public Health Service Act (42 U.S.C. 

18 300gg–11 et seq.) is amended by adding at the end the 

19 following: 

20 ‘‘SEC. 2729A. BENCHMARK FOR PAYMENT. 

21 ‘‘(a) ESTABLISHMENT OF BENCHMARK.—A group 

22 health plan or health insurance issuer offering group or 

23 individual health insurance coverage shall pay facilities or 

24 practitioners furnishing services for which such facilities 

25 and practitioners are prohibited from billing enrollees 


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1 under section 2719A(g), the median in-network rate, 

2 using a methodology determined under subsection (b) for 

3 the same or similar services offered by the group health 

4 plan or health insurance issuer in that geographic region. 

5 ‘‘(b) MEDIAN IN-NETWORK RATE.— 

6 ‘‘(1) IN GENERAL.—For purposes of this sec7 tion, the term ‘median in-network rate’ means, with 

8 respect to health care services covered by a group 

9 health plan or group or individual health insurance 

10 coverage, the median negotiated rate under the ap11 plicable plan or coverage recognized under the plan 

12 or coverage as the total maximum payment for the 

13 service minus the in-network cost-sharing for such 

14 service under the plan or coverage, for the same or 

15 a similar service that is provided by a provider in 

16 the same or similar specialty and in the geographic 

17 region in which the service is furnished. 

18 ‘‘(2) RULEMAKING.—Not later than 1 year 

19 after the date of enactment of the Lower Health 

20 Care Costs Act, the Secretary shall, through rule21 making, determine the methodology a group health 

22 plan or health insurance issuer is required to use to 

23 determine the median in-network rate described in 

24 paragraph (1), differentiating by business line, the 

25 information the plan or issuer shall share with the 


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1 nonparticipating provider involved when making 

2 such a determination, and the geographic regions 

3 applied for purposes of this subparagraph. Such 

4 rulemaking shall take into account payments that 

5 are made by health insurance issuers that are not on 

6 a fee-for-service basis. 

7 ‘‘(3) CERTAIN INSURERS.—If a group health 

8 plan or health insurance issuer offering group or in9 dividual health insurance coverage does not have 

10 sufficient information to calculate a median in-net11 work rate for this service or provider type, or 

12 amount of, claims for services (as determined by the 

13 applicable State authority, in the case of health in14 surance coverage, or by the Secretary of Labor, in 

15 the case of a self-insured group health plan) covered 

16 under the list of out-of-network services set by the 

17 State authority or Secretary of Labor, as applicable, 

18 in a particular geographic area, such plan or issuer 

19 shall demonstrate that it will use a database free of 

20 conflicts of interest that has sufficient information 

21 reflecting allowed amounts paid to individual health 

22 care providers for relevant services provided in the 

23 applicable geographic region, and that such plan or 

24 issuer will use that database to determine a median 

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1 surance issuer shall cover the cost of accessing the 

2 database. 

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

4 this subsection shall prevent a group health plan or 

5 health insurance issuer from establishing separate 

6 calculations of a median in-network rate under para7 graph (1) for services delivered in nonhospital facili8 ties, including freestanding emergency rooms. 

9 ‘‘(c) FACILITY.—For purposes of this section, the 

10 term ‘health care facility’ includes hospitals, hospital out11 patient departments, critical access hospitals, ambulatory 

12 surgery centers, laboratories, radiology clinics, and any 

13 other facility that provides services that are covered under 

14 a group health plan or health insurance coverage, includ15 ing settings of care subject to section 2719A(b).’’. 

16 (b) NON-FEDERAL GOVERNMENTAL PLANS.—Sec17 tion 2722(a)(2)(E) of the Public Health Service Act (42 

18 U.S.C. 300gg–21(a)(2)(E)) is amended by inserting ‘‘, ex19 cept that such election shall be available with respect to 

20 section 2729A’’ before the period. 

21 SEC. 104. EFFECTIVE DATE. 

22 The amendments made by sections 101, 102, and 103 

23 shall take effect beginning in the second plan year that 

24 begins after the date of enactment of this Act. 


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1 SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS. 

2 (a) IN GENERAL.—Part A of title XXVII of the Pub3 lic Health Service Act is amended by inserting after sec4 tion 2719A (42 U.S.C. 300gg–19a) the following: 

5 ‘‘SEC. 2719B. ENDING SURPRISE AIR AMBULANCE BILLS. 

6 ‘‘(a) IN GENERAL.—In the case of an enrollee in a 

7 group health plan or group or individual health insurance 

8 coverage who receives air ambulance services from an out9 of-network provider— 

10 ‘‘(1) the cost-sharing requirement (expressed as 

11 a copayment amount, coinsurance rate, or deduct12 ible) with respect to such services shall be the same 

13 requirement that would apply if such services were 

14 provided by an in-network practitioner, and any co15 insurance or deductible shall be based on in-network 

16 rates; and 

17 ‘‘(2) such cost-sharing amounts shall be count18 ed towards the in-network deductible and in-network 

19 out-of-pocket maximum amount under the plan or 

20 coverage for the plan year. 

21 ‘‘(b) PAYMENT RATE.—A group health plan or health 

22 insurance issuer shall pay for air ambulance services for 

23 purposes of subsection (a) at the median in-network as 

24 defined in subsection (c). 

25 ‘‘(c) MEDIAN IN-NETWORK RATE.— 


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1 ‘‘(1) IN GENERAL.—For purposes of this sec2 tion, the term ‘median in-network rate’ means, with 

3 respect to air ambulance services covered by a group 

4 health plan or group or individual health insurance 

5 coverage, the median negotiated rate under the ap6 plicable plan or coverage recognized under the plan 

7 or coverage as the total maximum payment for the 

8 service, minus the in-network cost-sharing for such 

9 service under the plan or coverage, for the same or 

10 a similar service that is provided by a provider in 

11 the same or similar specialty, and in the geographic 

12 region in which the service is furnished. 

13 ‘‘(2) RULEMAKING.—Not later than 6 months 

14 after the date of enactment of the Lower Health 

15 Care Costs Act, the Secretary shall, through rule16 making, determine the methodology a group health 

17 plan or health insurance issuer is required to use to 

18 determine the median in-network rate described in 

19 paragraph (1), the information the plan or issuer 

20 shall share with the non-participating provider in21 volved when making such a determination, and the 

22 geographic regions applied for purposes of this sub23 section. Such rulemaking shall take into account 

24 payments that are made by issuers that are not on 

25 a fee-for-service basis. 


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1 ‘‘(3) CERTAIN INSURERS.—If a group health 

2 plan or health insurance issuer offering group or in3 dividual health insurance coverage does not have 

4 sufficient information to calculate a median in-net5 work rate for this service or provider type, or 

6 amount of, claims for services (as determined by the 

7 applicable State authority, in the case of health in8 surance coverage, or by the Secretary of Labor, in 

9 the case of a self-insured group health plan) covered 

10 under the list of out-of-network services set by the 

11 State authority or Secretary of Labor, as applicable, 

12 in a particular geographic area, such plan or issuer 

13 shall demonstrate that it will use a database free of 

14 conflicts of interest that has sufficient information 

15 reflecting allowed amounts paid to individual health 

16 care providers for relevant services provided in the 

17 applicable geographic region, and that such plan or 

18 issuer will use that database to determine a median 

19 in-network rate. The group health plan or health in20 surance issuer shall cover the cost of accessing the 

21 database. 

22 ‘‘(4) CLARIFICATION.—For purposes of this 

23 subsection, the Secretary may define geographic re24 gions that are different from the geographic regions 

25 identified for purposes of section 2729A(b) to ensure 


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1 that an adequate number of air ambulance services 

2 are in-network in each geographic region so that a 

3 median in-network rate for air ambulance services 

4 may be calculated for each such region. 

5 ‘‘(d) COST-SHARING LIMITATION.—An air ambulance 

6 service provider may not bill an enrollee in a group health 

7 plan or group or individual health insurance coverage for 

8 amounts beyond the cost-sharing amount that applies 

9 under subsection (a). 

10 ‘‘(e) ENFORCEMENT.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

12 an air ambulance service provider that violates sub13 section (d) shall be subject to a civil monetary pen14 alty of not more than $10,000 for each act consti15 tuting such violation. 

16 ‘‘(2) PROCEDURE.—The provisions of section 

17 1128A of the Social Security Act, other than sub18 sections (a) and (b) and the first sentence of sub19 section (c)(1) of such section, shall apply to civil 

20 money penalties under this subsection in the same 

21 manner as such provisions apply to a penalty or pro22 ceeding under section 1128A of the Social Security 

23 Act. 

24 ‘‘(3) SAFE HARBOR.—The Secretary shall waive 

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1 spect to an air ambulance service provider who un2 knowingly violates subsection (d) with respect to an 

3 enrollee, if such air ambulance service provider with4 in 30 days of the violation, withdraws the bill that 

5 was in violation of subsection (d), and, as applicable, 

6 reimburses the group health plan, health insurance 

7 issuer, or enrollee, as applicable, in an amount equal 

8 to the amount billed in violation of subsection (d), 

9 plus interest, at an interest rate determined by the 

10 Secretary.’’. 

11 (b) EFFECTIVE DATE.—Section 2719B of the Public 

12 Health Service Act, as added by subsection (a), shall take 

13 effect on the date that is 1 year after the date of enact14 ment of this Act. 

15 SEC. 106. REPORT. 

16 Not later than 1 year after the effective date de17 scribed in section 104, and annually for the following 4 

18 years, the Secretary of Health and Human Services, in 

19 consultation with the Federal Trade Commission and the 

20 Attorney General, shall— 

21 (1) conduct a study on— 

22 (A) the effects of the amendments made by 

23 sections 101, 102, and 103, including any pat24 terns of vertical or horizontal integration of 


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1 health care facilities, providers, group health 

2 plans, or health insurance issuers; 

3 (B) the effects of the amendments made 

4 by sections 101, 102, and 103 on overall health 

5 care costs; and 

6 (C) recommendations for effective enforce7 ment of 2729A as added by section 103, includ8 ing potential challenges to addressing anti-com9 petitive consolidation by health care facilities, 

10 providers, group health plans, or health insur11 ance issuers; and 

12 (2) submit a report on such study to the Com13 mittee on Health, Education, Labor, and Pensions, 

14 the Committee on Commerce, Science, and Trans15 portation, the Committee on Finance, and the Com16 mittee on the Judiciary of the Senate and the Com17 mittee on Education and Labor, the Committee on 

18 Energy and Commerce, the Committee on Ways and 

19 Means, and the Committee on the Judiciary of the 

20 House of Representatives. 


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1 TITLE II—REDUCING THE 

2 PRICES OF PRESCRIPTION 

3 DRUGS 

4 SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 

5 (a) IN GENERAL.—Section 351 of the Public Health 

6 Service Act (42 U.S.C. 262) is amended by adding at the 

7 end the following: 

8 ‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT

9 TO PATENTS.— 

10 ‘‘(1) APPROVED APPLICATION HOLDER LISTING

11 REQUIREMENTS.— 

12 ‘‘(A) IN GENERAL.—Beginning on the date 

13 of enactment of the Lower Health Care Costs 

14 Act, within 60 days of approval of an applica15 tion under subsection (a) or (k), the holder of 

16 such approved application shall submit to the 

17 Secretary a list of each patent required to be 

18 disclosed (as described in paragraph (3)). 

19 ‘‘(B) PREVIOUSLY APPROVED OR LI20 CENSED BIOLOGICAL PRODUCTS.— 

21 ‘‘(i) PRODUCTS LICENSED UNDER

22 SECTION 351 OF THE PHSA.—Not later 

23 than 30 days after the date of enactment 

24 of the Lower Health Care Costs Act, the 

25 holder of a biological product license that 


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1 was approved under subsection (a) or (k) 

2 before the date of enactment of such Act 

3 shall submit to the Secretary a list of each 

4 patent required to be disclosed (as de5 scribed in paragraph (3)). 

6 ‘‘(ii) PRODUCTS APPROVED UNDER

7 SECTION 505 OF THE FFDCA.—Not later 

8 than 30 days after March 23, 2020, the 

9 holder of an approved application for a bio10 logical product under section 505 of the 

11 Federal Food, Drug, and Cosmetic Act 

12 that is deemed to be a license for the bio13 logical product under this section on 

14 March 23, 2020, shall submit to the Sec15 retary a list of each patent required to be 

16 disclosed (as described in paragraph (3)). 

17 ‘‘(C) UPDATES.—The holder of a biological 

18 product license that is the subject of an applica19 tion under subsection (a) or (k) shall submit to 

20 the Secretary a list that includes— 

21 ‘‘(i) any patent not previously re22 quired to be disclosed (as described in 

23 paragraph (3)) under subparagraph (A) or 

24 (B), as applicable, within 30 days of the 

25 earlier of— 


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1 ‘‘(I) the date of issuance of such 

2 patent by the United States Patent 

3 and Trademark Office; or 

4 ‘‘(II) the date of approval of a 

5 supplemental application for the bio6 logical product; and 

7 ‘‘(ii) any patent, or any claim with re8 spect to a patent, included on the list pur9 suant to this paragraph, that the Patent 

10 Trial and Appeal Board of the United 

11 States Patent and Trademark Office deter12 mines in a decision to be invalid or unen13 forceable, within 30 days of such decision. 

14 ‘‘(2) PUBLICATION OF INFORMATION.— 

15 ‘‘(A) IN GENERAL.—Within 1 year of the 

16 date of enactment of the Lower Health Care 

17 Costs Act, the Secretary shall publish and make 

18 available to the public a single, easily search19 able, list that includes— 

20 ‘‘(i) the official and proprietary name 

21 of each biological product licensed under 

22 subsection (a) or (k), and of each biological 

23 product application approved under section 

24 505 of the Federal Food, Drug, and Cos25 metic Act and deemed to be a license for 


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1 the biological product under this section on 

2 March 23, 2020; 

3 ‘‘(ii) with respect to each biological 

4 product described in clause (i), each patent 

5 submitted in accordance with paragraph 

6 (1); 

7 ‘‘(iii) the date of approval and appli8 cation number for each such biological 

9 product; 

10 ‘‘(iv) the marketing status, dosage 

11 form, route of administration, strength, 

12 and, if applicable, reference product, for 

13 each such biological product; 

14 ‘‘(v) the licensure status for each such 

15 biological product, including whether the li16 cense at the time of listing is approved, 

17 withdrawn, or revoked; 

18 ‘‘(vi) with respect to each such bio19 logical product, any period of any exclu20 sivity under paragraph (6), (7)(A), or 

21 (7)(B) of subsection (k) of this section or 

22 section 527 of the Federal Food, Drug, 

23 and Cosmetic Act, and any extension of 

24 such period in accordance with subsection 

25 (m) of this section, for which the Secretary 


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1 has determined such biological product to 

2 be eligible, and the date on which such ex3 clusivity expires; 

4 ‘‘(vii) information regarding any de5 termination of biosimilarity or interchange6 ability for each such biological product; 

7 and 

8 ‘‘(viii) information regarding approved 

9 indications for each such biological prod10 uct, in such manner as the Secretary de11 termines appropriate. 

12 ‘‘(B) UPDATES.—Every 30 days after the 

13 publication of the first list under subparagraph 

14 (A), the Secretary shall revise the list to in15 clude— 

16 ‘‘(i)(I) each biological product licensed 

17 under subsection (a) or (k) during the 30- 

18 day period; and 

19 ‘‘(II) with respect to each biological 

20 product described in subclause (I), the in21 formation described in clauses (i) through 

22 (viii) of subparagraph (A); and 

23 ‘‘(ii) any updates to information pre24 viously published in accordance with sub25 paragraph (A). 


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1 ‘‘(C) NONCOMPLIANCE.—Beginning 18 

2 months after the date of enactment of the 

3 Lower Health Care Costs Act, the Secretary, in 

4 consultation with the Director of the United 

5 States Patent and Trademark Office, shall pub6 lish and make available to the public a list of 

7 any holders of biological product licenses, and 

8 the corresponding biological product or prod9 ucts, that failed to submit information as re10 quired under paragraph (1), including any up11 dates required under paragraph (1)(C), in such 

12 manner and format as the Secretary determines 

13 appropriate. If information required under 

14 paragraph (1) is submitted following publica15 tion of such list, the Secretary shall remove 

16 such holders of such biological product licenses 

17 from the public list in a reasonable period of 

18 time. 

19 ‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 

20 In this section, a ‘patent required to be disclosed’ is 

21 any patent for which the holder of a biological prod22 uct license approved under subsection (a) or (k), or 

23 a biological product application approved under sec24 tion 505 of the Federal Food, Drug, and Cosmetic 

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1 uct under this section on March 23, 2020, believes 

2 a claim of patent infringement could reasonably be 

3 asserted by the holder, or by a patent owner that 

4 has granted an exclusive license to the holder with 

5 respect to the biological product that is the subject 

6 of such license, if a person not licensed by the holder 

7 engaged in the making, using, offering to sell, sell8 ing, or importing into the United States of the bio9 logical product that is the subject of such license.’’. 

10 (b) DISCLOSURE OF PATENTS.—Section 

11 351(l)(3)(A)(i) of the Public Health Service Act (42 

12 U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 

13 in the list provided by the reference product sponsor under 

14 subsection (o)(1)’’ after ‘‘a list of patents’’. 

15 (c) REVIEW AND REPORT ON NONCOMPLIANCE.— 

16 Not later than 30 months after the date of enactment of 

17 this Act, the Secretary shall— 

18 (1) solicit public comments regarding appro19 priate remedies, in addition to the publication of the 

20 list under subsection (o)(2)(C) of section 351 of the 

21 Public Health Service Act (42 U.S.C. 262), as added 

22 by subsection (a), with respect to holders of biologi23 cal product licenses who fail to timely submit infor24 mation as required under subsection (o)(1) of such 


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1 section 351, including any updates required under 

2 subparagraph (C) of such subsection (o)(1); and 

3 (2) submit to Congress an evaluation of com4 ments received under paragraph (1) and the rec5 ommendations of the Secretary concerning appro6 priate remedies. 

7 (d) REGULATIONS.—The Secretary of Health and 

8 Human Services may promulgate regulations to carry out 

9 subsection (o) of section 351 of the Public Health Service 

10 Act (42 U.S.C. 262), as added by subsection (a). 

11 (e) RULE OF CONSTRUCTION.—Nothing in this Act, 

12 including an amendment made by this Act, shall be con13 strued to require or allow the Secretary of Health and 

14 Human Services to delay the licensing of a biological prod15 uct under section 351 of the Public Health Service Act 

16 (42 U.S.C. 262). 

17 SEC. 202. ORANGE BOOK MODERNIZATION. 

18 (a) SUBMISSION OF PATENT INFORMATION FOR

19 BRAND NAME DRUGS.— 

20 (1) IN GENERAL.—Paragraph (1) of section 

21 505(b) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 355(b)) is amended to read as follows: 

23 ‘‘(b)(1)(A) Any person may file with the Secretary 

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1 visions of subsection (a). Such persons shall submit to the 

2 Secretary as part of the application— 

3 ‘‘(i) full reports of investigations which have 

4 been made to show whether or not such drug is safe 

5 for use and whether such drug is effective in use; 

6 ‘‘(ii) a full list of the articles used as compo7 nents of such drug; 

8 ‘‘(iii) a full statement of the composition of 

9 such drug; 

10 ‘‘(iv) a full description of the methods used in, 

11 and the facilities and controls used for, the manufac12 ture, processing, and packing of such drug; 

13 ‘‘(v) such samples of such drug and of the arti14 cles used as components thereof as the Secretary 

15 may require; 

16 ‘‘(vi) specimens of the labeling proposed to be 

17 used for such drug; 

18 ‘‘(vii) any assessments required under section 

19 505B; and 

20 ‘‘(viii) the patent number and expiration date, 

21 of each patent for which a claim of patent infringe22 ment could reasonably be asserted if a person not li23 censed by the owner engaged in the manufacture, 

24 use, or sale of the drug, and that— 


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1 ‘‘(I) claims the drug for which the appli2 cant submitted the application and is a drug 

3 substance patent or a drug product patent; or 

4 ‘‘(II) claims the method of using the drug 

5 for which approval is sought or has been grant6 ed in the application. 

7 ‘‘(B) If an application is filed under this subsection 

8 for a drug, and a patent of the type described in subpara9 graph (A)(viii) that claims such drug or a method of using 

10 such drug is issued after the filing date but before ap11 proval of the application, the applicant shall amend the 

12 application to include such patent information. 

13 ‘‘(C) Upon approval of the application, the Secretary 

14 shall publish the information submitted under subpara15 graph (A)(viii).’’. 

16 (2) GUIDANCE.—The Secretary of Health and 

17 Human Services shall, in consultation with the Di18 rector of the National Institutes of Health and with 

19 representatives of the drug manufacturing industry, 

20 review and develop guidance, as appropriate, on the 

21 inclusion of women and minorities in clinical trials 

22 required under subsection (b)(1)(A)(i) of section 505 

23 of the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 355), as amended by paragraph (1). 


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1 (b) CONFORMING CHANGES TO REQUIREMENTS FOR

2 SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 

3 Section 505(c)(2) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 355(j)(7)) is amended— 

5 (1) by inserting before the first sentence the 

6 following: ‘‘Not later than 30 days after the date of 

7 approval of an application under subsection (b), the 

8 holder of the approved application shall file with the 

9 Secretary the patent number and the expiration date 

10 of any patent described in subclause (I) or (II) of 

11 subsection (b)(1)(A)(viii), except that a patent that 

12 claims a method of using such drug shall be filed 

13 only if approval for such use has been granted in the 

14 application. The holder of the approved application 

15 shall file with the Secretary the patent number and 

16 the expiration date of any patent described in sub17 clause (I) or (II) of subsection (b)(1)(A)(viii) that is 

18 issued after the date of approval of the application, 

19 not later than 30 days of the date of issuance of the 

20 patent, except that a patent that claims a method of 

21 using such drug shall be filed only if approval for 

22 such use has been granted in the application.’’; 

23 (2) by inserting after ‘‘the patent number and 

24 the expiration date of any patent which’’ the fol25 lowing: ‘‘fulfills the criteria in subsection (b) and’’; 


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1 (3) by inserting after the third sentence (as 

2 amended by paragraph (1)) the following: ‘‘Patent 

3 information that is not the type of patent informa4 tion required by subsection (b)(1)(A)(viii) shall not 

5 be submitted under this paragraph.’’; and 

6 (4) by inserting after ‘‘could not file patent in7 formation under subsection (b) because no patent’’ 

8 the following: ‘‘of the type required to be submitted 

9 in subsection (b)’’. 

10 (c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) 

11 of section 505(j)(7) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355(j)(7)) is amended by adding at 

13 the end the following: 

14 ‘‘(iv) For each drug included on the list, the Sec15 retary shall specify any exclusivity period that is applica16 ble, for which the Secretary has determined the expiration 

17 date, and for which such period has not yet expired 

18 under— 

19 ‘‘(I) clause (ii), (iii), or (iv) of subsection 

20 (c)(3)(E) of this section; 

21 ‘‘(II) clause (iv) or (v) of paragraph (5)(B) of 

22 this subsection; 

23 ‘‘(III) clause (ii), (iii), or (iv) of paragraph 

24 (5)(F) of this subsection; 

25 ‘‘(IV) section 505A; 


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1 ‘‘(V) section 505E; 

2 ‘‘(VI) section 527(a); or 

3 ‘‘(VII) section 505(u)’’. 

4 (d) ORANGE BOOK UPDATES WITH RESPECT TO IN5 VALIDATED PATENTS.— 

6 (1) IN GENERAL.— 

7 (A) AMENDMENTS.—Section 505(j)(7)(A) 

8 of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355(j)(7)(A)), as amended by sub10 section (c), is further amended by adding at the 

11 end the following: 

12 ‘‘(v) In the case of a listed drug for which the 

13 list under clause (i) includes a patent or patent 

14 claim for the drug, or a patent or a patent claim for 

15 the use of such drug, and where the Under Sec16 retary of Commerce for Intellectual Property and 

17 Director of the United States Patent and Trade18 mark Office has canceled any claim of the patent re19 lating to such drug or such use pursuant to a deci20 sion by the Patent Trial and Appeal Board in an 

21 inter partes review conducted under chapter 31 of 

22 title 35, United States Code, or a post-grant review 

23 conducted under chapter 32 of that title, and from 

24 which no appeal has been taken, or can be taken, 

25 the holder of the applicable approved application 


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1 shall notify the Secretary, in writing, within 14 days 

2 of such cancellation, and, if the patent has been 

3 deemed wholly inoperative or invalid, or if a patent 

4 claim has been canceled, the revisions required 

5 under clause (iii) shall include striking the patent or 

6 information regarding such patent claim from the 

7 list with respect to such drug.’’. 

8 (B) APPLICATION.—The amendment made 

9 by subparagraph (A) shall not apply with re10 spect to any determination with respect to a 

11 patent or patent claim that is made prior to the 

12 date of enactment of this Act. 

13 (2) NO EFFECT ON FIRST APPLICANT EXCLU14 SIVITY PERIOD.—Section 505(j)(5)(B)(iv)(I) is 

15 amended by adding at the end the following: ‘‘This 

16 subclause shall apply even if a patent is stricken 

17 from the list under paragraph (7)(A), pursuant to 

18 paragraph (7)(A)(v), provided that, at the time that 

19 the first applicant submitted an application under 

20 this subsection containing a certification described in 

21 paragraph (2)(A)(vii)(IV), the patent that was the 

22 subject of such certification was included in such list 

23 with respect to the listed drug.’’. 


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1 SEC. 203. ENSURING TIMELY ACCESS TO GENERICS. 

2 Section 505(q) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355(q)(1)) is amended— 

4 (1) in paragraph (1)— 

5 (A) in subparagraph (A)(i), by inserting ‘‘, 

6 10.31,’’ after ‘‘10.30’’; 

7 (B) in subparagraph (E)— 

8 (i) by striking ‘‘application and’’ and 

9 inserting ‘‘application or’’; 

10 (ii) by striking ‘‘If the Secretary’’ and 

11 inserting the following: 

12 ‘‘(i) IN GENERAL.—If the Secretary’’; 

13 and 

14 (iii) by striking the second sentence 

15 and inserting the following: 

16 ‘‘(ii) PRIMARY PURPOSE OF DELAY17 ING.— 

18 ‘‘(I) IN GENERAL.—For purposes 

19 of this subparagraph, a petition or 

20 supplement to a petition may be con21 sidered to be submitted with the pri22 mary purpose of delaying an applica23 tion under subsection (b)(2) or (j) of 

24 this section or section 351(k) of the 

25 Public Health Service Act, if the peti26 tioner has the purpose of setting 


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1 aside, delaying, rescinding, with2 drawing, or preventing submission, re3 view, or the approval of such an appli4 cation. 

5 ‘‘(II) FACTORS.—In determining 

6 whether a petition was submitted with 

7 the primary purpose of delaying an 

8 application, the Secretary may con9 sider the following factors: 

10 ‘‘(aa) Whether the petition 

11 was submitted in accordance with 

12 paragraph (2)(B), based on when 

13 the petitioner knew or reasonably 

14 should have known the relevant 

15 information relied upon to form 

16 the basis of such petition. 

17 ‘‘(bb) Whether the petitioner 

18 has submitted multiple or serial 

19 petitions raising issues that rea20 sonably could have been known 

21 to the petitioner at the time of 

22 submission of the earlier petition 

23 or petitions. 

24 ‘‘(cc) Whether the petition 

25 was submitted close in time to a 


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1 known, first date upon which an 

2 application under subsection 

3 (b)(2) or (j) of this section or 

4 section 351(k) of the Public 

5 Health Service Act could be ap6 proved. 

7 ‘‘(dd) Whether the petition 

8 was submitted without any rel9 evant data or information in sup10 port of the scientific positions 

11 forming the basis of such peti12 tion. 

13 ‘‘(ee) Whether the petition 

14 raises the same or substantially 

15 similar issues as a prior petition 

16 to which the Secretary has re17 sponded substantively already, in18 cluding if the subsequent submis19 sion follows such response from 

20 the Secretary closely in time. 

21 ‘‘(ff) Whether the petition 

22 requests changing the applicable 

23 standards that other applicants 

24 are required to meet, including 

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1 ing standards that are more on2 erous or rigorous than the stand3 ards applicable to the listed drug, 

4 reference product, or petitioner’s 

5 version of the same drug. 

6 ‘‘(gg) The petitioner’s record 

7 of submitting petitions to the 

8 Food and Drug Administration 

9 that have been determined by the 

10 Secretary to have been submitted 

11 with the primary purpose of 

12 delay. 

13 ‘‘(hh) Other relevant and 

14 appropriate factors, which the 

15 Secretary shall describe in guid16 ance. 

17 ‘‘(III) GUIDANCE.—The Sec18 retary may issue or update guidance, 

19 as appropriate, to describe factors the 

20 Secretary considers in accordance 

21 with subclause (II).’’; 

22 (C) by adding at the end the following: 

23 ‘‘(iii) REFERRAL TO THE FEDERAL

24 TRADE COMMISSION.—The Secretary shall 

25 establish procedures for referring to the 


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1 Federal Trade Commission any petition or 

2 supplement to a petition that the Secretary 

3 determines was submitted with the primary 

4 purpose of delaying approval of an applica5 tion. Such procedures shall include notifi6 cation to the petitioner and an opportunity 

7 for judicial review after the issuance of an 

8 order by the Federal Trade Commission.’’; 

9 (D) by striking subparagraph (F); 

10 (E) by redesignating subparagraphs (G) 

11 through (I) as subparagraphs (F) through (H), 

12 respectively; and 

13 (F) in subparagraph (H), as so redesig14 nated, by striking ‘‘submission of this petition’’ 

15 and inserting ‘‘submission of this document’’; 

16 (2) in paragraph (2)— 

17 (A) by redesignating subparagraphs (A) 

18 through (C) as subparagraphs (C) through (E), 

19 respectively; 

20 (B) by inserting before subparagraph (C), 

21 as so redesignated, the following: 

22 ‘‘(A) IN GENERAL.—A person shall submit 

23 a petition to the Secretary under paragraph (1) 

24 before filing a civil action in which the person 

25 seeks to set aside, delay, rescind, withdraw, or 


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1 prevent submission, review, or approval of an 

2 application submitted under subsection (b)(2) 

3 or (j) of this section or section 351(k) of the 

4 Public Health Service Act. Such petition and 

5 any supplement to such a petition shall describe 

6 all information and arguments that form the 

7 basis of the relief requested in any civil action 

8 described in the previous sentence. 

9 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PE10 TITION.—A petition and any supplement to a 

11 petition shall be submitted within 60 days after 

12 the person knew, or reasonably should have 

13 known, the information that forms the basis of 

14 the request made in the petition or supple15 ment.’’; 

16 (C) in subparagraph (C), as so redesig17 nated, by— 

18 (i) in the heading, striking ‘‘WITHIN

19 150 DAYS’’; 

20 (ii) in clause (i), striking ‘‘during the 

21 150-day period referred to in paragraph 

22 (1)(F),’’; and 

23 (iii) amending clause (ii) to read as 

24 follows: 


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1 ‘‘(ii) on or after the date that is 151 

2 days after the date of submission of the 

3 petition, the Secretary approves or has ap4 proved the application that is the subject 

5 of the petition without having made such a 

6 final decision.’’; 

7 (D) by amending subparagraph (D), as so 

8 redesignated, to read as follows: 

9 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC10 TIONS.— 

11 ‘‘(i) PETITION.—If a person files a 

12 civil action against the Secretary in which 

13 a person seeks to set aside, delay, rescind, 

14 withdraw, or prevent submission, review, or 

15 approval of an application submitted under 

16 subsection (b)(2) or (j) of this section or 

17 section 351(k) of the Public Health Service 

18 Act without complying with the require19 ments of subparagraph (A), the court shall 

20 dismiss without prejudice the action for 

21 failure to exhaust administrative remedies. 

22 ‘‘(ii) TIMELINESS.—If a person files a 

23 civil action against the Secretary in which 

24 a person seeks to set aside, delay, rescind, 

25 withdraw, or prevent submission, review, or 


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1 approval of an application submitted under 

2 subsection (b)(2) or (j) of this section or 

3 section 351(k) of the Public Health Service 

4 Act without complying with the require5 ments of subparagraph (B), the court shall 

6 dismiss with prejudice the action for fail7 ure to timely file a petition. 

8 ‘‘(iii) FINAL RESPONSE.—If a civil ac9 tion is filed against the Secretary with re10 spect to any issue raised in a petition time11 ly filed under paragraph (1) in which the 

12 petitioner requests that the Secretary take 

13 any form of action that could, if taken, set 

14 aside, delay, rescind, withdraw, or prevent 

15 submission, review, or approval of an appli16 cation submitted under subsection (b)(2) 

17 or (j) of this section or section 351(k) of 

18 the Public Health Service Act before the 

19 Secretary has issued a final response to 

20 any such petition submitted, the court 

21 shall dismiss without prejudice the action 

22 for failure to exhaust administrative rem23 edies.’’; and 

24 (E) in subparagraph (E), as so redesig25 nated— 


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1 (i) in clause (ii), by striking ‘‘, if 

2 issued’’; and 

3 (ii) in clause (iii), by striking ‘‘final 

4 agency action as defined under subpara5 graph (2)(A)’’ and inserting ‘‘the final re6 sponse to the petitioner’’; and 

7 (3) in paragraph (4)— 

8 (A) by striking ‘‘EXCEPTIONS’’ and all that 

9 follows through ‘‘This subsection does’’ and in10 serting ‘‘EXCEPTIONS—This subsection does’’; 

11 (B) by striking subparagraph (B); and 

12 (C) by redesignating clauses (i) and (ii) as 

13 subparagraphs (A) and (B), respectively, and 

14 adjusting the margins accordingly. 

15 SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS. 

16 Section 351(k)(7) of the Public Health Service Act 

17 (42 U.S.C. 262(k)(7)) is amended by adding at the end 

18 the following: 

19 ‘‘(D) DEEMED LICENSES.— 

20 ‘‘(i) NO ADDITIONAL EXCLUSIVITY

21 THROUGH DEEMING.—An approved appli22 cation that is deemed to be a license for a 

23 biological product under this section pursu24 ant to section 7002(e)(4) of the Biologics 

25 Price Competition and Innovation Act of 


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1 2009 shall not be treated as having been 

2 first licensed under subsection (a) for pur3 poses of subparagraphs (A) and (B). 

4 ‘‘(ii) LIMITATION ON EXCLUSIVITY.— 

5 Subparagraph (C) shall apply to any ref6 erence product, without regard to wheth7 er— 

8 ‘‘(I) such product was first li9 censed under subsection (a); or 

10 ‘‘(II) the approved application for 

11 such product was deemed to be a li12 cense for a biological product as de13 scribed in clause (i). 

14 ‘‘(iii) APPLICABILITY.—Any unexpired 

15 period of exclusivity under section 527 or 

16 section 505A(c)(1)(A)(ii) of the Federal 

17 Food, Drug, and Cosmetic Act with re18 spect to a biological product shall continue 

19 to apply to such biological product after an 

20 approved application for the biological 

21 product is deemed to be a license for the 

22 biological product as described in clause 

23 (i).’’. 


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1 SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS. 

2 Section 505(j)(5)(B)(iv)(I) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) 

4 is amended— 

5 (1) by striking ‘‘180 days after the date’’ and 

6 inserting ‘‘180 days after the earlier of the fol7 lowing: 

8 ‘‘(aa) The date’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(bb) The date on which all of the fol11 lowing conditions are first met: 

12 ‘‘(AA) An application for the 

13 drug submitted by an applicant other 

14 than a first applicant could receive 

15 approval, if no first applicant were eli16 gible for 180-day exclusivity under 

17 this clause. 

18 ‘‘(BB) Thirty-three months have 

19 passed since the date of submission of 

20 an application for the drug by one 

21 first applicant, if there is only one 

22 first applicant, or, in the case of more 

23 than one first applicant, 33 months 

24 have passed since the date of submis25 sion of all such applications. 


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1 ‘‘(CC) Approval of an application 

2 for the drug submitted by at least one 

3 first applicant would not be precluded 

4 under clause (iii). 

5 ‘‘(DD) No application for the 

6 drug submitted by any first applicant 

7 is approved at the time the conditions 

8 under subitems (AA), (BB), and (CC) 

9 are all met, regardless of whether 

10 such an application is subsequently 

11 approved.’’. 

12 SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS. 

13 Subpart 1 of part F of title III of the Public Health 

14 Service Act (42 U.S.C. 262 et seq.) is amended by adding 

15 at the end the following: 

16 ‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 

17 ‘‘(a) INTERNET WEBSITE.— 

18 ‘‘(1) IN GENERAL.—The Secretary may estab19 lish, maintain, and operate an internet website to 

20 provide educational materials for health care pro21 viders, patients, and caregivers, regarding the mean22 ing of the terms, and the standards for review and 

23 licensing of, biological products, including biosimilar 

24 biological products and interchangeable biosimilar 

25 biological products. 


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1 ‘‘(2) CONTENT.—Educational materials pro2 vided under paragraph (1) may include explanations 

3 of— 

4 ‘‘(A) key statutory and regulatory terms, 

5 including ‘biosimilar’ and ‘interchangeable’, and 

6 clarification regarding the appropriate use of 

7 interchangeable biosimilar biological products; 

8 ‘‘(B) information related to development 

9 programs for biological products, including bio10 similar biological products and interchangeable 

11 biosimilar biological products and relevant clin12 ical considerations for prescribers, which may 

13 include, as appropriate and applicable, informa14 tion related to the comparability of such biologi15 cal products; 

16 ‘‘(C) the process for reporting adverse 

17 events for biological products, including bio18 similar biological products and interchangeable 

19 biosimilar biological products; and 

20 ‘‘(D) the relationship between biosimilar 

21 biological products and interchangeable bio22 similar biological products licensed under sec23 tion 351(k) and reference products (as defined 

24 in section 351(i)), including the standards for 


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1 review and licensing of each such type of bio2 logical product. 

3 ‘‘(3) FORMAT.—The educational materials pro4 vided under paragraph (1) may be— 

5 ‘‘(A) in formats such as webinars, con6 tinuing medical education modules, videos, fact 

7 sheets, infographics, stakeholder toolkits, or 

8 other formats as appropriate and applicable; 

9 and 

10 ‘‘(B) tailored for the unique needs of 

11 health care providers, patients, caregivers, and 

12 other audiences, as the Secretary determines 

13 appropriate. 

14 ‘‘(4) OTHER INFORMATION.—In addition to the 

15 information described in paragraph (2), the internet 

16 website established under paragraph (1) shall in17 clude the following information, as a single, search18 able database: 

19 ‘‘(A) The action package of each biological 

20 product licensed under subsection (a) or (k), 

21 within 30 days of licensure, or, in the case of 

22 a biological product licensed before the date of 

23 enactment of the Lower Health Care Costs Act, 

24 not later than 1 year after such date of enact25 ment. 


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1 ‘‘(B) The summary review of each biologi2 cal product licensed under subsection (a) or (k), 

3 within 7 days of licensure, except where such 

4 materials require redaction by the Secretary, or, 

5 in the case of a biological product licensed be6 fore the date of enactment of the Lower Health 

7 Care Costs Act, not later than 1 year after such 

8 date of enactment. 

9 ‘‘(5) CONFIDENTIAL AND TRADE SECRET IN10 FORMATION.—This subsection does not authorize 

11 the disclosure of any trade secret, confidential com12 mercial or financial information, or other matter de13 scribed in section 552(b) of title 5. 

14 ‘‘(b) CONTINUING MEDICAL EDUCATION.—The Sec15 retary shall advance education and awareness among 

16 health care providers regarding biological products, includ17 ing biosimilar biological products and interchangeable bio18 similar biological products, as appropriate, including by 

19 developing or improving continuing medical education pro20 grams that advance the education of such providers on the 

21 prescribing of, and relevant clinical considerations with re22 spect to biological products, including biosimilar biological 

23 products and interchangeable biosimilar biological prod24 ucts.’’. 


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1 SEC. 207. BIOLOGICAL PRODUCT INNOVATION. 

2 Section 351(j) of the Public Health Service Act (42 

3 U.S.C. 262(j)) is amended— 

4 (1) by striking ‘‘except that a product’’ and in5 serting ‘‘except that— 

6 ‘‘(1) a product’’; 

7 (2) by striking ‘‘Act.’’ and inserting ‘‘Act; and’’; 

8 and 

9 (3) by adding at the end the following: 

10 ‘‘(2) no requirement under such Act regarding 

11 an official compendium (as defined in section 201(j) 

12 of such Act), or other reference in such Act to an 

13 official compendium (as so defined), shall apply with 

14 respect to a biological product subject to regulation 

15 under this section.’’. 

16 SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL 

17 ENTITY. 

18 Chapter V of the Federal Food, Drug, and Cosmetic 

19 Act is amended— 

20 (1) in section 505 (21 U.S.C. 355)— 

21 (A) in subsection (c)(3)(E)— 

22 (i) in clause (ii), by striking ‘‘active 

23 ingredient (including any ester or salt of 

24 the active ingredient)’’ and inserting ‘‘ac25 tive moiety (as defined by the Secretary in 

26 section 314.3 of title 21, Code of Federal 


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1 Regulations (or any successor regula2 tions))’’; and 

3 (ii) in clause (iii), by striking ‘‘active 

4 ingredient (including any ester or salt of 

5 the active ingredient)’’ and inserting ‘‘ac6 tive moiety (as defined by the Secretary in 

7 section 314.3 of title 21, Code of Federal 

8 Regulations (or any successor regula9 tions))’’; 

10 (B) in subsection (j)(5)(F)— 

11 (i) in clause (ii), by striking ‘‘active 

12 ingredient (including any ester or salt of 

13 the active ingredient)’’ and inserting ‘‘ac14 tive moiety (as defined by the Secretary in 

15 section 314.3 of title 21, Code of Federal 

16 Regulations (or any successor regula17 tions))’’; and 

18 (ii) in clause (iii), by striking ‘‘active 

19 ingredient (including any ester or salt of 

20 the active ingredient)’’ and inserting ‘‘ac21 tive moiety (as defined by the Secretary in 

22 section 314.3 of title 21, Code of Federal 

23 Regulations (or any successor regula24 tions))’’; 


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1 (C) in subsection (l)(2)(A)(i), by striking 

2 ‘‘active ingredient (including any ester or salt of 

3 the active ingredient)’’ and inserting ‘‘active 

4 moiety (as defined by the Secretary in section 

5 314.3 of title 21, Code of Federal Regulations 

6 (or any successor regulations))’’; 

7 (D) in subsection (s), in the matter pre8 ceding paragraph (1), by striking ‘‘active ingre9 dient (including any ester or salt of the active 

10 ingredient)’’ and inserting ‘‘active moiety (as 

11 defined by the Secretary in section 314.3 of 

12 title 21, Code of Federal Regulations (or any 

13 successor regulations))’’; and 

14 (E) in subsection (u)(1), in the matter pre15 ceding subparagraph (A)— 

16 (i) by striking ‘‘active ingredient (in17 cluding any ester or salt of the active in18 gredient)’’ and inserting ‘‘active moiety (as 

19 defined by the Secretary in section 314.3 

20 of title 21, Code of Federal Regulations (or 

21 any successor regulations))’’; and 

22 (ii) by striking ‘‘same active ingre23 dient’’ and inserting ‘‘same active moiety’’; 

24 (2) in section 512(c)(2)(F) (21 U.S.C. 

25 360b(c)(2)(F))— 


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1 (A) in clause (i), by striking ‘‘active ingre2 dient (including any ester or salt of the active 

3 ingredient)’’ and inserting ‘‘active moiety (as 

4 defined by the Secretary in section 314.3 of 

5 title 21, Code of Federal Regulations (or any 

6 successor regulations))’’; 

7 (B) in clause (ii), by striking ‘‘active ingre8 dient (including any ester or salt of the active 

9 ingredient)’’ and inserting ‘‘active moiety (as 

10 defined by the Secretary in section 314.3 of 

11 title 21, Code of Federal Regulations (or any 

12 successor regulations))’’; and 

13 (C) in clause (v), by striking ‘‘active ingre14 dient (including any ester or salt of the active 

15 ingredient)’’ and inserting ‘‘active moiety (as 

16 defined by the Secretary in section 314.3 of 

17 title 21, Code of Federal Regulations (or any 

18 successor regulations))’’; 

19 (3) in section 524(a)(4)(C) (21 U.S.C. 

20 360n(a)(4)(C)), by striking ‘‘active ingredient (in21 cluding any ester or salt of the active ingredient)’’ 

22 and inserting ‘‘active moiety (as defined by the Sec23 retary in section 314.3 of title 21, Code of Federal 

24 Regulations (or any successor regulations))’’; 


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1 (4) in section 529(a)(4)(A)(ii) (21 U.S.C. 

2 360ff(a)(4)(A)(ii)), by striking ‘‘active ingredient 

3 (including any ester or salt of the active ingredient)’’ 

4 and inserting ‘‘active moiety (as defined by the Sec5 retary in section 314.3 of title 21, Code of Federal 

6 Regulations (or any successor regulations))’’; and 

7 (5) in section 565A(a)(4)(D) (21 U.S.C. 

8 360bbb–4a(a)(4)(D)), by striking ‘‘active ingredient 

9 (including any ester or salt of the active ingredient)’’ 

10 and inserting ‘‘active moiety (as defined by the Sec11 retary in section 314.3 of title 21, Code of Federal 

12 Regulations (or any successor regulations))’’. 

13 SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL 

14 PRODUCTS. 

15 Section 7002(e)(4) of the Biologics Price Competition 

16 and Innovation Act of 2009 (Public Law 111–148) is 

17 amended by adding at the end the following: ‘‘With respect 

18 to an application for a biological product under section 

19 505 of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 355) with a filing date that is not later than Sep21 tember 23, 2019, the Secretary shall continue to review 

22 and approve such application under section 505 of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), 

24 even if such review and approval process continues after 

25 March 23, 2020. Effective on the later of March 23, 2020, 


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1 or the date of approval of such application under such sec2 tion 505, such approved application shall be deemed to 

3 be a license for the biological product under section 351 

4 of the Public Health Service Act.’’. 

5 SEC. 210. ORPHAN DRUG CLARIFICATION. 

6 Section 527(c) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360cc(c)) is amended by adding at 

8 the end the following: 

9 ‘‘(3) APPLICABILITY.—This subsection applies 

10 to any drug designated under section 526 that was 

11 approved under section 505 of this Act or licensed 

12 under section 351 of the Public Health Service Act 

13 after the date of enactment of the FDA Reauthor14 ization Act of 2017, regardless of the date of on 

15 which such drug was designated under section 

16 526.’’. 

17 SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO 

18 SAFETY INFORMATION. 

19 Section 505 of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 355) is amended by adding at the end the 

21 following: 

22 ‘‘(z) PROMPT APPROVAL OF DRUGS WHEN SAFETY

23 INFORMATION IS ADDED TO LABELING.— 

24 ‘‘(1) GENERAL RULE.—A drug for which an ap25 plication has been submitted or approved under subVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 section (b)(2) or (j) shall not be considered ineligible 

2 for approval under this section or misbranded under 

3 section 502 on the basis that the labeling of the 

4 drug omits safety information, including contra5 indications, warnings, precautions, dosing, adminis6 tration, or other information pertaining to safety, 

7 when the omitted safety information is protected by 

8 exclusivity under clause (iii) or (iv) of subsection 

9 (j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), 

10 or section 527(a), or by an extension of such exclu11 sivity under section 505A or 505E. 

12 ‘‘(2) LABELING.—Notwithstanding clauses (iii) 

13 and (iv) of subsection (j)(5)(F), clauses (iii) and (iv) 

14 of subsection (c)(3)(E), or section 527, the Sec15 retary shall require that the labeling of a drug ap16 proved pursuant to an application submitted under 

17 subsection (b)(2) or (j) that omits safety information 

18 described in paragraph (1) include a statement of 

19 any appropriate safety information that the Sec20 retary considers necessary to assure safe use. 

21 ‘‘(3) AVAILABILITY AND SCOPE OF EXCLU22 SIVITY.—This subsection does not affect— 

23 ‘‘(A) the availability or scope of exclusivity 

24 or an extension of exclusivity described in sub25 paragraph (A) or (B) of section 505A(o)(3); 


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1 ‘‘(B) the question of the eligibility for ap2 proval under this section of any application de3 scribed in subsection (b)(2) or (j) that omits 

4 any other aspect of labeling protected by exclu5 sivity under— 

6 ‘‘(i) clause (iii) or (iv) of subsection 

7 (j)(5)(F); 

8 ‘‘(ii) clause (iii) or (iv) of subsection 

9 (c)(3)(E); or 

10 ‘‘(iii) section 527(a); or 

11 ‘‘(C) except as expressly provided in para12 graphs (1) and (2), the operation of this section 

13 or section 527.’’. 

14 SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGI15 CAL PRODUCTS. 

16 Section 351(k)(2)(A)(iii) of the Public Health Service 

17 Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended— 

18 (1) in subclause (I), by striking ‘‘; and’’ and in19 serting a semicolon; 

20 (2) in subclause (II), by striking the period and 

21 inserting ‘‘; and’’; and 

22 (3) by adding at the end the following: 

23 ‘‘(III) may include information to 

24 show that the conditions of use pre25 scribed, recommended, or suggested in 


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1 the labeling proposed for the biological 

2 product have been previously approved 

3 for the reference product.’’. 

4 SEC. 213. MODERNIZING THE LABELING OF CERTAIN GE5 NERIC DRUGS. 

6 Chapter V of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

8 section 503C the following: 

9 ‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 

10 DRUGS. 

11 ‘‘(a) DEFINITIONS.—For purposes of this section: 

12 ‘‘(1) The term ‘covered drug’ means a drug ap13 proved under section 505(c)— 

14 ‘‘(A) for which there are no unexpired pat15 ents included in the list under section 505(j)(7) 

16 and no unexpired period of market exclusivity; 

17 ‘‘(B) for which the approval of the applica18 tion has been withdrawn for reasons other than 

19 safety or effectiveness; and 

20 ‘‘(C) for which, with respect to the label21 ing— 

22 ‘‘(i) new scientific evidence is available 

23 regarding the conditions of use of the 

24 drug; 


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1 ‘‘(ii) there is a relevant accepted use 

2 in clinical practice that is not reflected in 

3 the approved labeling; or 

4 ‘‘(iii) the labeling of such drug does 

5 not reflect current legal and regulatory re6 quirements. 

7 ‘‘(2) The term ‘period of market exclusivity’, 

8 with respect to a drug approved under section 

9 505(c), means any period of market exclusivity 

10 under clause (ii), (iii), or (iv) of section 

11 505(c)(3)(E), clause (ii), (iii), or (iv) of section 

12 505(j)(5)(F), or section 505A, 505E, or 527. 

13 ‘‘(3) The term ‘generic version’ means a drug 

14 approved under section 505(j) whose reference drug 

15 is a covered drug. 

16 ‘‘(4) The term ‘relevant accepted use’ means a 

17 use for a drug in clinical practice that is supported 

18 by scientific evidence that appears to the Secretary 

19 to meet the standards for approval under section 

20 505. 

21 ‘‘(5) The term ‘selected drug’ means a covered 

22 drug for which the Secretary has determined 

23 through the process under subsection (c) that the la24 beling should be changed. 


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1 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The 

2 Secretary may identify covered drugs for which labeling 

3 updates would provide a public health benefit. To assist 

4 in identifying covered drugs, the Secretary may do one or 

5 both of the following: 

6 ‘‘(1) Enter into cooperative agreements or con7 tracts with public or private entities to review the 

8 available scientific evidence concerning such drugs. 

9 ‘‘(2) Seek public input concerning such drugs, 

10 including input on whether there is a relevant ac11 cepted use in clinical practice that is not reflected in 

12 the approved labeling of such drugs or whether new 

13 scientific evidence is available regarding the condi14 tions of use for such drug, by— 

15 ‘‘(A) holding one or more public meetings; 

16 ‘‘(B) opening a public docket for the sub17 mission of public comments; or 

18 ‘‘(C) other means, as the Secretary deter19 mines appropriate. 

20 ‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 

21 Secretary determines, with respect to a covered drug, that 

22 the available scientific evidence meets the standards under 

23 section 505 for adding or modifying information to the 

24 labeling or providing supplemental information to the laVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 beling regarding the use of the covered drug, the Secretary 

2 may initiate the process under subsection (d). 

3 ‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 

4 If the Secretary determines that labeling changes are ap5 propriate for a selected drug pursuant to subsection (c), 

6 the Secretary shall provide notice to the holders of ap7 proved applications for a generic version of such drug 

8 that— 

9 ‘‘(1) summarizes the findings supporting the 

10 determination of the Secretary that the available sci11 entific evidence meets the standards under section 

12 505 for adding or modifying information or pro13 viding supplemental information to the labeling of 

14 the covered drug pursuant to subsection (c); 

15 ‘‘(2) provides a clear statement regarding the 

16 additional, modified, or supplemental information for 

17 such labeling, according to the determination by the 

18 Secretary (including, as applicable, modifications to 

19 add the relevant accepted use to the labeling of the 

20 drug as an additional indication for the drug); and 

21 ‘‘(3) states whether the statement under para22 graph (2) applies to the selected drug as a class of 

23 covered drugs or only as to a specific drug product. 

24 ‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 

25 of receipt of notification provided by the Secretary pursuVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ant to subsection (d), the holder of an approved applica2 tion for a generic version of the selected drug shall— 

3 ‘‘(1) agree to change the approved labeling to 

4 reflect the additional, modified, or supplemental in5 formation the Secretary has determined to be appro6 priate; or 

7 ‘‘(2) notify the Secretary that the holder of the 

8 approved application does not believe that the re9 quested labeling changes are warranted and submit 

10 a statement detailing the reasons why such changes 

11 are not warranted. 

12 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE13 SPONSE.— 

14 ‘‘(1) IN GENERAL.—Upon receipt of the appli15 cation holder’s response, the Secretary shall prompt16 ly review each statement received under subsection 

17 (e)(2) and determine which labeling changes pursu18 ant to the Secretary’s notice under subsection (d) 

19 are appropriate, if any. If the Secretary disagrees 

20 with the reasons why such labeling changes are not 

21 warranted, the Secretary shall provide opportunity 

22 for discussions with the application holders to reach 

23 agreement on whether the labeling for the covered 

24 drug should be updated to reflect current scientific 


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1 evidence, and if so, the content of such labeling 

2 changes. 

3 ‘‘(2) CHANGES TO LABELING.—After consid4 ering all responses from the holder of an approved 

5 application under paragraph (1) or (2) of subsection 

6 (e), and any discussion under paragraph (1), the 

7 Secretary may order such holder to make the label8 ing changes the Secretary determines are appro9 priate. Such holder of an approved application 

10 shall— 

11 ‘‘(A) update its paper labeling for the drug 

12 at the next printing of that labeling; 

13 ‘‘(B) update any electronic labeling for the 

14 drug within 30 days; and 

15 ‘‘(C) submit the revised labeling through 

16 the form, ‘Supplement—Changes Being Ef17 fected’. 

18 ‘‘(g) VIOLATION.—If the holder of an approved appli19 cation for the generic version of the selected drug does 

20 not comply with the requirements of subsection (f)(2), 

21 such generic version of the selected drug shall be deemed 

22 to be misbranded under section 502. 

23 ‘‘(h) LIMITATIONS; GENERIC DRUGS.— 

24 ‘‘(1) IN GENERAL.—With respect to any label25 ing change required under this section, the generic 


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1 version shall be deemed to have the same conditions 

2 of use and the same labeling as a reference drug for 

3 purposes of clauses (i) and (v) of section 

4 505(j)(2)(A). Any labeling change so required shall 

5 not have any legal effect for the applicant that is 

6 different than the legal effect that would have re7 sulted if a supplemental application had been sub8 mitted and approved to conform the labeling of the 

9 generic version to a change in the labeling of the ref10 erence drug. 

11 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 

12 to labeling made in accordance with this paragraph 

13 shall not be eligible for an exclusivity period under 

14 this Act. 

15 ‘‘(i) DRUG PRODUCT CLASSES.—In the case of a se16 lected drug for which the labeling changes ordered by the 

17 Secretary under subsection (d)(2) are required for a class 

18 of covered drugs, such labeling changes shall be made for 

19 generic versions of such drug in that class. 

20 ‘‘(j) RULES OF CONSTRUCTION.— 

21 ‘‘(1) APPROVAL STANDARDS.—This section 

22 shall not be construed as altering the applicability of 

23 the standards for approval of an application under 

24 section 505. No order shall be issued under this sub25 section unless the evidence supporting the changed 


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1 labeling meets the standards for approval applicable 

2 to any change to labeling under section 505. 

3 ‘‘(2) REMOVAL OF INFORMATION.—Nothing in 

4 this section shall be construed to give the Secretary 

5 additional authority to remove approved indications 

6 for drugs, other than the authority to remove certain 

7 indications from the labels of certain covered drugs, 

8 as described in this section. 

9 ‘‘(k) REPORTS.—Not later than 4 years after the 

10 date of the enactment of the Lower Health Care Costs 

11 Act and every 4 years thereafter, the Secretary shall pre12 pare and submit to the Committee on Health, Education, 

13 Labor, and Pensions of the Senate and the Committee on 

14 Energy and Commerce of the House of Representatives, 

15 a report that— 

16 ‘‘(1) describes the actions of the Secretary 

17 under this section, including— 

18 ‘‘(A) the number of covered drugs and de19 scription of the types of drugs the Secretary 

20 has selected for labeling changes and the ra21 tionale for such recommended changes; and 

22 ‘‘(B) the number of times the Secretary 

23 entered into discussions concerning a disagree24 ment with an application holder or holders and 


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1 a summary of the decision regarding a labeling 

2 change, if any; and 

3 ‘‘(2) includes any recommendations of the Sec4 retary for modifying the program under this sec5 tion.’’. 

6 TITLE III—IMPROVING TRANS7 PARENCY IN HEALTH CARE 

8 SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG 

9 CLAUSES ON PRICE AND QUALITY INFORMA10 TION. 

11 Subpart II of part A of title XXVII of the Public 

12 Health Service Act (42 U.S.C. 300gg–11 et seq.), as 

13 amended by section 103, is amended by adding at the end 

14 the following: 

15 ‘‘SEC. 2729B. INCREASING TRANSPARENCY BY REMOVING 

16 GAG CLAUSES ON PRICE AND QUALITY IN17 FORMATION. 

18 ‘‘(a) INCREASING PRICE AND QUALITY TRANS19 PARENCY FOR PLAN SPONSORS AND CONSUMERS.— 

20 ‘‘(1) GROUP HEALTH PLANS.—A group health 

21 plan or a health insurance issuer offering group 

22 health insurance coverage may not enter into an 

23 agreement with a health care provider, network or 

24 association of providers, third-party administrator, 

25 or other service provider offering access to a network 


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1 of providers that would directly or indirectly restrict 

2 a group health plan or health insurance issuer 

3 from— 

4 ‘‘(A) providing provider-specific cost or 

5 quality of care information, through a consumer 

6 engagement tool or any other means, to refer7 ring providers, the plan sponsor, enrollees, or 

8 eligible enrollees of the plan or coverage; 

9 ‘‘(B) electronically accessing de-identified 

10 claims and encounter data for each enrollee in 

11 the plan or coverage, upon request and con12 sistent with the privacy regulations promul13 gated pursuant to section 264(c) of the Health 

14 Insurance Portability and Accountability Act, 

15 the amendments to this Act made by the Ge16 netic Information Nondiscrimination Act of 

17 2008, and the Americans with Disabilities Act 

18 of 1990, with respect to the applicable health 

19 plan or health insurance coverage, including, on 

20 a per claim basis— 

21 ‘‘(i) financial information, such as the 

22 allowed amount, or any other claim-related 

23 financial obligations included in the pro24 vider contract; 


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1 ‘‘(ii) provider information, including 

2 name and clinical designation; 

3 ‘‘(iii) service codes; or 

4 ‘‘(iv) any other data element normally 

5 included in claim or encounter transactions 

6 when received by a plan or issuer; or 

7 ‘‘(C) sharing data described in subpara8 graph (A) or (B) with a business associate as 

9 defined in section 160.103 of title 45, Code of 

10 Federal Regulations (or successor regulations), 

11 consistent with the privacy regulations promul12 gated pursuant to section 264(c) of the Health 

13 Insurance Portability and Accountability Act, 

14 the amendments to this Act made by the Ge15 netic Information Nondiscrimination Act of 

16 2008, and the Americans with Disabilities Act 

17 of 1990. 

18 ‘‘(2) INDIVIDUAL HEALTH INSURANCE COV19 ERAGE.—A health insurance issuer offering indi20 vidual health insurance coverage may not enter into 

21 an agreement with a health care provider, network 

22 or association of providers, or other service provider 

23 offering access to a network of providers that would, 

24 directly or indirectly restrict the health insurance 

25 issuer from— 


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1 ‘‘(A) providing provider-specific price or 

2 quality of care information, through a consumer 

3 engagement tool or any other means, to refer4 ring providers or the plan sponsor, enrollees, or 

5 eligible enrollees of the plan or coverage; or 

6 ‘‘(B) sharing data described in subpara7 graph (A) with a business associate as defined 

8 in section 160.103 of title 45, Code of Federal 

9 Regulations (or successor regulations), con10 sistent with the privacy regulations promul11 gated pursuant to section 264(c) of the Health 

12 Insurance Portability and Accountability Act, 

13 the amendments to this Act made by the Ge14 netic Information Nondiscrimination Act of 

15 2008, and the Americans with Disabilities Act 

16 of 1990, for plan design, plan administration, 

17 and plan, financial, legal, and quality improve18 ment activities. 

19 ‘‘(3) CLARIFICATION REGARDING PUBLIC DIS20 CLOSURE OF INFORMATION.—Nothing in paragraph 

21 (1)(A) or (2)(A) prevents a health care provider, 

22 network or association of providers, or other service 

23 provider from placing reasonable restrictions on the 

24 public disclosure of the information described in 

25 such paragraphs (1) and (2). 


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1 ‘‘(4) ATTESTATION.—A group health plan or a 

2 health insurance issuer offering group or individual 

3 health insurance coverage shall annually submit to, 

4 as applicable, the applicable authority described in 

5 section 2723 or the Secretary of Labor, an attesta6 tion that such plan or issuer is in compliance with 

7 the requirements of this subsection. 

8 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in 

9 this section shall be construed to otherwise limit 

10 group health plan or plan sponsor access to data 

11 currently permitted under the privacy regulations 

12 promulgated pursuant to section 264(c) of the 

13 Health Insurance Portability and Accountability Act, 

14 the amendments to this Act made by the Genetic In15 formation Nondiscrimination Act of 2008, and the 

16 Americans with Disabilities Act of 1990.’’. 

17 SEC. 302. BANNING ANTICOMPETITIVE TERMS IN FACILITY 

18 AND INSURANCE CONTRACTS THAT LIMIT AC19 CESS TO HIGHER QUALITY, LOWER COST 

20 CARE. 

21 (a) IN GENERAL.—Section 2729B of the Public 

22 Health Service Act, as added by section 301, is amended 

23 by adding at the end the following: 

24 ‘‘(b) PROTECTING HEALTH PLANS NETWORK DE25 SIGN FLEXIBILITY.— 


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1 ‘‘(1) IN GENERAL.—A group health plan or a 

2 health insurance issuer offering group or individual 

3 health insurance coverage shall not enter into an 

4 agreement with a provider, network or association of 

5 providers, or other service provider offering access to 

6 a network of service providers if such agreement, di7 rectly or indirectly— 

8 ‘‘(A) restricts the group health plan or 

9 health insurance issuer from— 

10 ‘‘(i) directing or steering enrollees to 

11 other health care providers; or 

12 ‘‘(ii) offering incentives to encourage 

13 enrollees to utilize specific health care pro14 viders; 

15 ‘‘(B) requires the group health plan or 

16 health insurance issuer to enter into any addi17 tional contract with an affiliate of the provider 

18 as a condition of entering into a contract with 

19 such provider; 

20 ‘‘(C) requires the group health plan or 

21 health insurance issuer to agree to payment 

22 rates or other terms for any affiliate not party 

23 to the contract of the provider involved; or 

24 ‘‘(D) restricts other group health plans or 

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1 tract, from paying a lower rate for items or 

2 services than the contracting plan or issuer 

3 pays for such items or services. 

4 ‘‘(2) ADDITIONAL REQUIREMENT FOR SELF-IN5 SURED PLANS.—A self-insured group health plan 

6 shall not enter into an agreement with a provider, 

7 network or association of providers, third-party ad8 ministrator, or other service provider offering access 

9 to a network of providers if such agreement, directly 

10 or indirectly requires the group health plan to cer11 tify, attest, or otherwise confirm in writing that the 

12 group health plan is bound by the terms of the con13 tract between the service provider and a third-party 

14 administrator that the group health plan is not 

15 party to and is not allowed to review. 

16 ‘‘(3) EXCEPTION FOR CERTAIN GROUP MODEL

17 ISSUERS.—Paragraph (1)(A) shall not apply to a 

18 group health plan or a health insurance issuer offer19 ing group or individual health insurance coverage 

20 with respect to a health maintenance organization 

21 (as defined in section 2791(b)(3)) if such health 

22 maintenance organization operates primarily through 

23 exclusive contracts with multi-specialty physician 

24 groups, nor to any arrangement between such a 

25 health maintenance organization and its affiliates. 


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1 ‘‘(4) ATTESTATION.—A group health plan or a 

2 health insurance issuer offering group or individual 

3 health insurance coverage shall annually submit to, 

4 as applicable, the applicable authority described in 

5 section 2723 or the Secretary of Labor, an attesta6 tion that such plan or issuer is in compliance with 

7 the requirements of this subsection. 

8 ‘‘(c) MAINTENANCE OF EXISTING HIPAA, GINA, 

9 AND ADA PROTECTIONS.—Nothing in this section shall 

10 modify, reduce, or eliminate the existing privacy protec11 tions and standards provided by reason of State and Fed12 eral law, including the requirements of parts 160 and 164 

13 of title 45, Code of Federal Regulations (or any successor 

14 regulations). 

15 ‘‘(d) REGULATIONS.—The Secretary, in coordination 

16 with the Secretary of Labor and the Secretary of the 

17 Treasury, not later than 1 year after the date of enact18 ment of the Lower Health Care Costs Act, shall promul19 gate regulations to carry out this section. 

20 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed to limit network design or cost or 

22 quality initiatives by a group health plan or health insur23 ance issuer, including accountable care organizations, ex24 clusive provider organizations, networks that tier providers 


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1 by cost or quality or steer enrollees to centers of excel2 lence, or other pay-for-performance programs.’’. 

3 (b) EFFECTIVE DATE.—Section 2729B of the Public 

4 Health Service Act (as added by section 301 and amended 

5 by subsection (a)) shall apply with respect to any contract 

6 entered into after the date of enactment of this Act. With 

7 respect to an applicable contract that is in effect on the 

8 date of enactment of this Act, such section 2729B shall 

9 apply on the earlier of the date of renewal of such contract 

10 or 3 years after such date of enactment. 

11 SEC. 303. DESIGNATION OF A NONGOVERNMENTAL, NON12 PROFIT TRANSPARENCY ORGANIZATION TO 

13 LOWER AMERICANS’ HEALTH CARE COSTS. 

14 (a) IN GENERAL.—Subpart C of part 7 of subtitle 

15 B of title I of the Employee Retirement Income Security 

16 Act of 1974 (29 U.S.C. 1191 et seq.) is amended by add17 ing at the end the following: 

18 ‘‘SEC. 735. DESIGNATION OF A NONGOVERNMENTAL, NON19 PROFIT TRANSPARENCY ORGANIZATION TO 

20 LOWER AMERICANS’ HEALTH CARE COSTS. 

21 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

22 with the Secretary of Health and Human Services, not 

23 later than 6 months after the date of enactment of the 

24 Lower Health Care Costs Act, shall have in effect a con25 tract with a nonprofit entity to support the establishment 


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1 and maintenance of a database that receives and utilizes 

2 health care claims information and related information 

3 and issues reports that are available to the public and au4 thorized users, and are submitted to the Department of 

5 Labor. 

6 ‘‘(b) REQUIREMENTS.— 

7 ‘‘(1) IN GENERAL.—The database established 

8 under subsection (a) shall— 

9 ‘‘(A) improve transparency by using de10 identified health care data to— 

11 ‘‘(i) inform patients about the cost, 

12 quality, and value of their care; 

13 ‘‘(ii) assist providers and hospitals, as 

14 they work with patients, to make informed 

15 choices about care; 

16 ‘‘(iii) enable providers, hospitals, and 

17 communities to improve services and out18 comes for patients by benchmarking their 

19 performance against that of other pro20 viders, hospitals, and communities; 

21 ‘‘(iv) enable purchasers, including em22 ployers, employee organizations, and health 

23 plans, to develop value-based purchasing 

24 models, improve quality, and reduce the 


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1 cost of health care and insurance coverage 

2 for enrollees; 

3 ‘‘(v) enable employers and employee 

4 organizations to evaluate network design 

5 and construction, and the cost of care for 

6 enrollees; 

7 ‘‘(vi) facilitate State-led initiatives to 

8 lower health care costs and improve qual9 ity; and 

10 ‘‘(vii) promote competition based on 

11 quality and cost; 

12 ‘‘(B) collect medical claims, prescription 

13 drug claims, and remittance data consistent 

14 with the protections and requirements of sub15 section (d); 

16 ‘‘(C) be established in such a manner that 

17 allows the data collected pursuant to subpara18 graph (B) to be shared with any State all-payer 

19 claims database or regional database operated 

20 with authorization from States, at cost, using a 

21 standardized format, if such State or regional 

22 database also submits claims data to the data23 base established under this section; and 

24 ‘‘(D) be available to— 


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1 ‘‘(i) the Director of the Congressional 

2 Budget Office, the Comptroller General of 

3 the United States, the Executive Director 

4 of the Medicare Payment Advisory Com5 mission, and the Executive Director of the 

6 Medicaid and CHIP Payment Advisory 

7 Commission, upon request, subject to the 

8 privacy and security requirements of au9 thorized users under subsection (e)(2); and 

10 ‘‘(ii) authorized users, including em11 ployers, employee organizations, providers, 

12 researchers, and policymakers, subject to 

13 subsection (e). 

14 ‘‘(2) PRIVACY AND SECURITY.—The entity re15 ceiving a contract under subsection (a) shall— 

16 ‘‘(A) be subject to the breach notification 

17 rule under subpart D of part 164 of title 45, 

18 Code of Federal Regulations (or any successor 

19 regulations), the security rule under part 160 

20 and subparts A and C of part 164 of title 45, 

21 Code of Federal Regulations (or any successor 

22 regulations), and the privacy rule under part 

23 160 and subparts A and E of part 164 of title 

24 45, Code of Federal Regulations (or any suc25 cessor regulations); and 


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1 ‘‘(B) consistent with the requirements and 

2 prohibitions in the regulations promulgated 

3 under section 264(c) of the Health Insurance 

4 Portability and Accountability Act of 1996— 

5 ‘‘(i) ensure that the database under 

6 subsection (a) is capable of— 

7 ‘‘(I) receiving data under sub8 section (d); 

9 ‘‘(II) providing data access to au10 thorized users; and 

11 ‘‘(III) storing data on secure 

12 servers in a manner that is consistent 

13 with the privacy, security, and breach 

14 notification requirements under sec15 tion 13402 of the HITECH Act and 

16 under the regulations promulgated 

17 under section 264(c) of the Health In18 surance Portability and Accountability 

19 Act of 1996; 

20 ‘‘(ii) not disclose to the public any in21 dividually identifiable health information or 

22 proprietary financial information; 

23 ‘‘(iii) strictly limit staff access to the 

24 data to staff with appropriate training, 


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1 clearance, and background checks and re2 quire regular privacy and security training; 

3 ‘‘(iv) maintain effective security 

4 standards for transferring data or making 

5 data available to authorized users; 

6 ‘‘(v) develop a process for providing 

7 access to data to authorized users, in a se8 cure manner that maintains privacy and 

9 confidentiality of data; 

10 ‘‘(vi) adhere to current best security 

11 practices with respect to the management 

12 and use of such data for health services re13 search, in accordance with applicable Fed14 eral privacy law; and 

15 ‘‘(vii) report on the security methods 

16 of the entity to the Secretary, the Com17 mittee on Health, Education, Labor, and 

18 Pensions of the Senate, and the Committee 

19 on Education and Labor of the House of 

20 Representatives. 

21 ‘‘(3) CONSULTATION.— 

22 ‘‘(A) ADVISORY COMMITTEE.—Not later 

23 than 180 days after the date of enactment of 

24 the Lower Health Care Costs Act, the Secretary 

25 shall convene an Advisory Committee (referred 


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1 to in this section as the ‘Committee’), con2 sisting of 11 members, to advise the Secretary, 

3 the contracting entity, and Congress on the es4 tablishment, operations, and use of the data5 base established under this section. 

6 ‘‘(B) MEMBERSHIP.— 

7 ‘‘(i) APPOINTMENT.—In accordance 

8 with clause (ii), the Secretary, in consulta9 tion with the Secretary of Health and 

10 Human Services, and the Comptroller Gen11 eral of the United States shall, not later 

12 than 1 year after the date of enactment of 

13 the Lower Health Care Costs Act, appoint 

14 members to the Committee who have dis15 tinguished themselves in the fields of 

16 health services research, health economics, 

17 health informatics, or the governance of 

18 State all-payer claims databases, or who 

19 represent organizations likely to submit 

20 data to or use the database, including pa21 tients, employers, or employee organiza22 tions that sponsor group health plans, 

23 health care providers, health insurance 

24 issuers, and third-party administrators of 

25 group health plans. Such members shall 


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1 serve 3-year terms on a staggered basis. 

2 Vacancies on the Committee shall be filled 

3 by appointment consistent with this sub4 section not later than 3 months after the 

5 vacancy arises. 

6 ‘‘(ii) COMPOSITION.—In accordance 

7 with clause (i)— 

8 ‘‘(I) the Secretary, in consulta9 tion with the Secretary of Health and 

10 Human Services, shall appoint to the 

11 Committee— 

12 ‘‘(aa) 1 member selected by 

13 the Secretary, in coordination 

14 with the Secretary of Health and 

15 Human Services, to serve as the 

16 chair of the Committee; 

17 ‘‘(bb) the Assistant Sec18 retary for Planning and Evalua19 tion of the Department of Health 

20 and Human Services; 

21 ‘‘(cc) 1 representative of the 

22 Centers for Medicare & Medicaid 

23 Services; 


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1 ‘‘(dd) 1 representative of the 

2 Agency for Health Research and 

3 Quality; 

4 ‘‘(ee) 1 representative of the 

5 Office for Civil Rights of the De6 partment of Health and Human 

7 Services with expertise in data 

8 privacy and security; and 

9 ‘‘(ff) 1 representative of the 

10 National Center for Health Sta11 tistics; and 

12 ‘‘(II) the Comptroller General of 

13 the United States shall appoint to the 

14 Committee— 

15 ‘‘(aa) 1 representative of an 

16 employer that sponsors a group 

17 health plan; 

18 ‘‘(bb) 1 representative of an 

19 employee organization that spon20 sors a group health plan; 

21 ‘‘(cc) 1 academic researcher 

22 with expertise in health econom23 ics or health services research; 

24 ‘‘(dd) 1 patient advocate; 

25 and 


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1 ‘‘(ee) 2 additional members. 

2 ‘‘(C) DUTIES.—The Committee shall— 

3 ‘‘(i) assist and advise the Secretary on 

4 the management of the contract under sub5 section (a); 

6 ‘‘(ii) assist and advise the entity re7 ceiving the contract under subsection (a) in 

8 establishing— 

9 ‘‘(I) the scope and format of the 

10 data to be submitted under subsection 

11 (d); 

12 ‘‘(II) the appropriate uses of 

13 data by authorized users, including 

14 developing standards for the approval 

15 of requests by organizations to access 

16 and use the data; and 

17 ‘‘(III) the appropriate formats 

18 and methods for making reports and 

19 analyses based on the database to the 

20 public; 

21 ‘‘(iii) conduct an annual review of 

22 whether data was used according to the 

23 appropriate uses as described in clause 

24 (ii)(II), and advise the designated entity on 

25 using the data for authorized purposes; 


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1 ‘‘(iv) report, as appropriate, to the 

2 Secretary and Congress on the operation of 

3 the database and opportunities to better 

4 achieve the objectives of this section; 

5 ‘‘(v) establish additional restrictions 

6 on researchers who receive compensation 

7 from entities described in subsection 

8 (e)(2)(B)(ii), in order to protect propri9 etary financial information; and 

10 ‘‘(vi) establish objectives for research 

11 and public reporting. 

12 ‘‘(4) STATE REQUIREMENTS.—A State may re13 quire health insurance issuers and other payers to 

14 submit claims data to the database established 

15 under this section, provided that such data is sub16 mitted in a form and manner established by the Sec17 retary, and pursuant to subsection (d)(4)(B). 

18 ‘‘(5) SANCTIONS.—The Secretary shall take ap19 propriate action to sanction users who attempt to re20 identify data accessed pursuant to paragraph 

21 (1)(D). 

22 ‘‘(c) CONTRACT REQUIREMENTS.— 

23 ‘‘(1) COMPETITIVE PROCEDURES.—The Sec24 retary shall enter into the contract under subsection 


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1 (a) using full and open competition procedures pur2 suant to chapter 33 of title 41, United States Code. 

3 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to 

4 enter into a contract described in subsection (a), an 

5 entity shall— 

6 ‘‘(A) be a private nonprofit entity governed 

7 by a board that includes representatives of the 

8 academic research community and individuals 

9 with expertise in employer-sponsored insurance, 

10 research using health care claims data and ac11 tuarial analysis; 

12 ‘‘(B) conduct its business in an open and 

13 transparent manner that provides the oppor14 tunity for public comment on its activities; and 

15 ‘‘(C) agree to maintain an active certifi16 cation as a qualified entity under section 

17 1874(e) of the Social Security Act (or any suc18 cessor program) throughout the contract period. 

19 ‘‘(3) CONSIDERATIONS.—In awarding the con20 tract under subsection (a), the Secretary shall con21 sider an entity’s experience in— 

22 ‘‘(A) health care claims data collection, ag23 gregation, quality assurance, analysis, and secu24 rity; 


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1 ‘‘(B) supporting academic research on 

2 health costs, spending, and utilization for and 

3 by privately insured patients; 

4 ‘‘(C) working with large health insurance 

5 issuers and third-party administrators to as6 semble a national claims database; 

7 ‘‘(D) effectively collaborating with and en8 gaging stakeholders to develop reports; 

9 ‘‘(E) meeting budgets and timelines, in10 cluding in connection with report generation; 

11 and 

12 ‘‘(F) facilitating the creation of, or sup13 porting, State all-payer claims databases. 

14 ‘‘(4) CONTRACT TERM.—A contract awarded 

15 under this section shall be for a period of 5 years, 

16 and may be renewed after a subsequent competitive 

17 bidding process under this section. 

18 ‘‘(5) TRANSITION OF CONTRACT.—If the Sec19 retary, following a competitive process at the end of 

20 the contract period, selects a new entity to maintain 

21 the database, all data shall be transferred to the new 

22 entity according to a schedule and process to be de23 termined by the Secretary. Upon termination of a 

24 contract, no entity may keep data held by the data25 base or disclose such data to any entity other than 


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1 the entity so designated by the Secretary. The Sec2 retary shall include enforcement terms in any con3 tract with an organization chosen under this section, 

4 to ensure the timely transfer of all data to a new en5 tity in the event of contract termination. 

6 ‘‘(d) RECEIVING HEALTH INFORMATION.— 

7 ‘‘(1) REQUIREMENTS.— 

8 ‘‘(A) IN GENERAL.—An applicable self-in9 sured group health plan shall, through its 

10 health insurance issuer, third-party adminis11 trator, pharmacy benefit manager, or other en12 tity designated by the group health plan, elec13 tronically submit all claims data with respect to 

14 the plan, pursuant to subparagraph (B). 

15 ‘‘(B) SCOPE OF INFORMATION AND FOR16 MAT OF SUBMISSION.—The entity awarded the 

17 contract under subsection (a), in consultation 

18 with the Committee described in subsection 

19 (b)(3), and pursuant to the privacy and security 

20 requirements of subsection (b)(2), shall— 

21 ‘‘(i) specify the data elements required 

22 to be submitted under subparagraph (A), 

23 which shall include all data related to 

24 transactions described in subparagraphs 

25 (A) and (E) of section 1173(a)(2) of the 


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1 Social Security Act, including all data ele2 ments normally present in such trans3 actions when adjudicated, and enrollment 

4 information; 

5 ‘‘(ii) specify the form and manner for 

6 such submissions, and the historical period 

7 to be included in the initial submission; 

8 and 

9 ‘‘(iii) offer an automated submission 

10 option to minimize administrative burdens 

11 for entities required to submit data. 

12 ‘‘(C) DE-IDENTIFICATION OF DATA.—The 

13 entity awarded the contract under subsection 

14 (a) shall— 

15 ‘‘(i) establish a process under which 

16 data is de-identified in accordance with 

17 section 164.514(a) of title 45, Code of 

18 Federal Regulations (or any successor reg19 ulations), while retaining the ability to link 

20 data longitudinally for the purposes of re21 search on cost and quality, and the ability 

22 to complete risk adjustment and geo23 graphic analysis; 

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1 tion process described in clause (i) retain 

2 the minimum necessary information to per3 form such a process, and adhere to effec4 tive security and encryption practices in 

5 data storage and transmission; 

6 ‘‘(iii) store claims and other data col7 lected under this subsection only in de8 identified form, in accordance with section 

9 164.514(a) of title 45, Code of Federal 

10 Regulations (or any successor regulations); 

11 and 

12 ‘‘(iv) ensure that data is encrypted, in 

13 accordance with the regulations promul14 gated under section 264(c) of the Health 

15 Insurance Portability and Accountability 

16 Act of 1996. 

17 ‘‘(2) APPLICABLE SELF-INSURED GROUP

18 HEALTH PLAN.—For purposes of paragraph (1), a 

19 self-insured group health plan is an applicable self20 insured group health plan if such plan is self-admin21 istered, or is administered by a health insurance 

22 issuer or third-party administrator that meets one or 

23 both of the following criteria: 

24 ‘‘(A) Administers health benefits for more 

25 than 50,000 enrollees. 


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1 ‘‘(B) Is one of the 5 largest administrators 

2 or issuers of self-insured group health plans in 

3 a State in which such administrator operates, 

4 as measured by the number of enrollees. 

5 ‘‘(3) ISSUERS AND THIRD-PARTY ADMINISTRA6 TORS.—In the case of a health insurance issuer or 

7 third-party administrator that is required under this 

8 subsection to submit claims data with respect to an 

9 applicable self-insured group health plan, such issuer 

10 or administrator shall submit claims data with re11 spect to all self-insured group health plans that the 

12 issuer or administrator administers, including such 

13 plans that are not applicable self-insured group 

14 health plans, as described in paragraph (2). 

15 ‘‘(4) RECEIVING OTHER INFORMATION.— 

16 ‘‘(A) MEDICARE DATA.—The entity award17 ed the contract under subsection (a) shall main18 tain active certification as a qualified entity 

19 pursuant to section 1874(e) of the Social Secu20 rity Act for the term of the contract awarded 

21 under subsection (a). 

22 ‘‘(B) STATE DATA.—The entity awarded 

23 the contract under subsection (a) shall collect 

24 data from State all-payer claims databases that 


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1 seek access to the database established under 

2 this section. 

3 ‘‘(5) AVAILABILITY OF DATA.—An entity re4 quired to submit data under this subsection may not 

5 place any restrictions on the use of such data by au6 thorized users. 

7 ‘‘(e) USES OF INFORMATION.— 

8 ‘‘(1) IN GENERAL.—The entity awarded the 

9 contract under subsection (a) shall make the data10 base available to users who are authorized under 

11 this subsection, at cost, and reports and analyses 

12 based on the data available to the public with no 

13 charge. 

14 ‘‘(2) AUTHORIZATION OF USERS.— 

15 ‘‘(A) IN GENERAL.—An entity may request 

16 authorization by the entity awarded the con17 tract under subsection (a) for access to the 

18 database in accordance with this paragraph. 

19 ‘‘(B) APPLICATION.—An entity desiring 

20 authorization under this paragraph shall submit 

21 to the entity awarded the contract an applica22 tion for such access, which shall include— 

23 ‘‘(i) in the case of an entity requesting 

24 access for research purposes— 


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1 ‘‘(I) a description of the uses and 

2 methodologies for evaluating health 

3 system performance using such data; 

4 and 

5 ‘‘(II) documentation of approval 

6 of the research by an institutional re7 view board, if applicable for a par8 ticular plan of research; or 

9 ‘‘(ii) in the case of an entity such as 

10 an employer, health insurance issuer, 

11 third-party administrator, or health care 

12 provider, requesting access for the purpose 

13 of quality improvement or cost-contain14 ment, a description of the intended uses 

15 for such data. 

16 ‘‘(C) REQUIREMENTS.— 

17 ‘‘(i) RESEARCH.—Upon approval of 

18 an application for research purposes under 

19 subparagraph (B)(i), the authorized user 

20 shall enter into a data use and confiden21 tiality agreement with the entity awarded 

22 the contract under subsection (a), which 

23 shall include a prohibition on attempts to 

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1 formation and proprietary financial infor2 mation. 

3 ‘‘(ii) QUALITY IMPROVEMENT AND

4 COST-CONTAINMENT.—In consultation with 

5 the Committee described in subsection 

6 (b)(3), the Secretary shall, through rule7 making, establish the form and manner in 

8 which authorized users described in sub9 paragraph (B)(ii) may access data. Data 

10 provided to such authorized users shall be 

11 provided in a form and manner such that 

12 users may not obtain individually identifi13 able price information with respect to di14 rect competitors. Upon approval, such au15 thorized user shall enter into a data use 

16 and confidentiality agreement with the en17 tity. 

18 ‘‘(iii) CUSTOMIZED REPORTS.—Em19 ployers and employer organizations may 

20 request customized reports from the entity 

21 awarded the contract under subsection (a), 

22 at cost, subject to the requirements of this 

23 section with respect to privacy, security, 

24 and proprietary financial information. 


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1 ‘‘(iv) NON-CUSTOMIZED REPORTS.— 

2 The entity awarded the contract under 

3 subsection (a), in consultation with the 

4 Committee, shall make available to all au5 thorized users aggregate data sets, free of 

6 charge. 

7 ‘‘(f) FUNDING.— 

8 ‘‘(1) INITIAL FUNDING.—There are authorized 

9 to be appropriated, and there are appropriated, out 

10 of monies in the Treasury not otherwise appro11 priated, $20,000,000 for fiscal year 2020, for the 

12 implementation of the initial contract and establish13 ment of the database under this section. 

14 ‘‘(2) ONGOING FUNDING.—There are author15 ized to be appropriated $15,000,000 for each of fis16 cal years 2021 through 2025, for purposes of car17 rying out this section (other than the grant program 

18 under subsection (h)). 

19 ‘‘(g) ANNUAL REPORT.— 

20 ‘‘(1) SUBMISSION.—Not later than March 1, 

21 2021, and March 1 of each year thereafter, the enti22 ty receiving the contract under subsection (a) shall 

23 submit to Congress, the Secretary of Labor, and the 

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1 lish online for access by the general public, a report 

2 containing a description of— 

3 ‘‘(A) trends in the price, utilization, and 

4 total spending on health care services, including 

5 a geographic analysis of differences in such 

6 trends; 

7 ‘‘(B) limitations in the data set; 

8 ‘‘(C) progress towards the objectives of 

9 this section; and 

10 ‘‘(D) the performance by the entity of the 

11 duties required under such contract. 

12 ‘‘(2) PUBLIC REPORTS AND RESEARCH.—The 

13 entity receiving a contract under subsection (a) 

14 shall, in coordination with authorized users, make 

15 analyses and research available to the public on an 

16 ongoing basis to promote the objectives of this sec17 tion. 

18 ‘‘(h) GRANTS TO STATES.— 

19 ‘‘(1) IN GENERAL.—The Secretary, in consulta20 tion with the Secretary of Health and Human Serv21 ices, may award grants to States for the purpose of 

22 establishing and maintaining State all-payer claims 

23 databases that improve transparency of data in 

24 order to meet the goals of subsection (a)(1). 


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1 ‘‘(2) REQUIREMENT.—To be eligible to receive 

2 the funding under paragraph (1), a State shall sub3 mit data to the database as described in subsection 

4 (b)(1)(C), using the format described in subsection 

5 (d)(1). 

6 ‘‘(3) FUNDING.—There is authorized to be ap7 propriated $100,000,000 for the period of fiscal 

8 years 2020 through 2029 for the purpose of award9 ing grants to States under this subsection. 

10 ‘‘(i) EXEMPTION FROM PUBLIC DISCLOSURE.— 

11 ‘‘(1) IN GENERAL.—Claims data provided to 

12 the database, and the database itself shall not be 

13 considered public records and shall be exempt from 

14 public disclosure requirements. 

15 ‘‘(2) RESTRICTIONS ON USES FOR CERTAIN

16 PROCEEDINGS.—Data disclosed to authorized users 

17 shall not be subject to discovery or admission as 

18 public information, or evidence in judicial or admin19 istrative proceedings without consent of the affected 

20 parties. 

21 ‘‘(j) DEFINITIONS.— 

22 ‘‘(1) PROTECTED HEALTH INFORMATION.—The 

23 term ‘protected health information’ has the meaning 

24 given such term in section 160.103 of title 45, Code 


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1 of Federal Regulations (or any successor regula2 tions). 

3 ‘‘(2) PROPRIETARY FINANCIAL INFORMATION.— 

4 The term ‘proprietary financial information’ means 

5 data that would disclose the terms of a specific con6 tract between an individual health care provider or 

7 facility and a specific group health plan, Medicaid 

8 managed care organization or other managed care 

9 entity, or health insurance issuer offering group or 

10 individual coverage. 

11 ‘‘(k) RULE OF CONSTRUCTION.—Nothing in this sec12 tion shall be construed to affect or modify enforcement 

13 of the privacy, security, or breach notification rules pro14 mulgated under section 264(c) of the Health Insurance 

15 Portability and Accountability Act of 1996 (or successor 

16 regulations).’’. 

17 (b) GAO REPORT.— 

18 (1) IN GENERAL.—The Comptroller General of 

19 the United States shall conduct a study on— 

20 (A) the performance of the entity awarded 

21 a contract under section 735(a) of the Em22 ployee Retirement Income Security Act of 1974, 

23 as added by subsection (a), under such con24 tract; 


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1 (B) the privacy and security of the infor2 mation reported to the entity; and 

3 (C) the costs incurred by such entity in 

4 performing such duties. 

5 (2) REPORTS.—Not later than 2 years after the 

6 effective date of the first contract entered into under 

7 section 735(a) of the Employee Retirement Income 

8 Security Act of 1974, as added by subsection (a), 

9 and again not later than 4 years after such effective 

10 date, the Comptroller General of the United States 

11 shall submit to Congress a report containing the re12 sults of the study conducted under paragraph (1), 

13 together with recommendations for such legislation 

14 and administrative action as the Comptroller Gen15 eral determines appropriate. 

16 (c) CLERICAL AMENDMENT.—The table of contents 

17 in section 1 of the Employee Retirement Income Security 

18 Act of 1974 is amended by inserting after the item relat19 ing to section 734 the following new item: 

‘‘Sec. 735. Designation of a nongovernmental, nonprofit transparency organization to lower Americans’ health care costs.’’. 

20 SEC. 304. PROTECTING PATIENTS AND IMPROVING THE AC21 CURACY OF PROVIDER DIRECTORY INFOR22 MATION. 

23 Subpart II of part A of title XXVII of the Public 

24 Health Service Act (42 U.S.C. 300gg–11 et seq.), as 


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1 amended by sections 301 and 302, is further amended by 

2 adding at the end the following: 

3 ‘‘SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE 

4 ACCURACY OF PROVIDER DIRECTORY INFOR5 MATION. 

6 ‘‘(a) NETWORK STATUS OF PROVIDERS.— 

7 ‘‘(1) IN GENERAL.—Beginning on the date that 

8 is one year after the date of enactment of this sec9 tion, a group health plan or a health insurance 

10 issuer offering group or individual health insurance 

11 coverage shall— 

12 ‘‘(A) establish business processes to ensure 

13 that all enrollees in such plan or coverage re14 ceive proof of a health care provider’s network 

15 status— 

16 ‘‘(i) through a written electronic com17 munication from the plan or issuer to the 

18 enrollee, as soon as practicable and not 

19 later than 1 business day after a telephone 

20 inquiry is made by such enrollee for such 

21 information; and 

22 ‘‘(ii) in real-time through an online 

23 health care provider directory search tool 

24 maintained by the plan or issuer; and 


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1 ‘‘(B) include in any print directory a dis2 closure that the information included in the di3 rectory is accurate as of the date of the last 

4 data update and that enrollees or prospective 

5 enrollees should consult the group health plan 

6 or issuer’s electronic provider directory on its 

7 website or call a specified customer service tele8 phone number to obtain the most current pro9 vider directory information. 

10 ‘‘(2) GROUP HEALTH PLAN AND HEALTH IN11 SURANCE ISSUER BUSINESS PROCESSES.—Beginning 

12 on the date that is one year after the date of enact13 ment of the Lower Health Care Costs Act, a group 

14 health plan or a health insurance issuer offering 

15 group or individual health insurance coverage shall 

16 establish business processes to— 

17 ‘‘(A) verify and update, at least once every 

18 90 days, the provider directory information for 

19 all providers included in the online health care 

20 provider directory search tool described in para21 graph (1)(A)(ii); and 

22 ‘‘(B) remove any provider from such online 

23 directory search tool if such provider has not 

24 verified the directory information within the 

25 previous 6 months or the plan or issuer has 


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1 been unable to verify the provider’s network 

2 participation. 

3 ‘‘(b) COST-SHARING LIMITATIONS.— 

4 ‘‘(1) IN GENERAL.—A group health plan or a 

5 health insurance issuer offering group or individual 

6 health insurance coverage shall not apply, and shall 

7 ensure that no provider applies cost-sharing to an 

8 enrollee for treatment or services provided by a 

9 health care provider in excess of the normal cost10 sharing applied for in-network care (including any 

11 balance bill issued by the health care provider in12 volved), if such enrollee, or health care provider re13 ferring such enrollee, demonstrates (based on the 

14 electronic information described in subsection 

15 (a)(1)(A)(i) or a copy of the online provider direc16 tory described in subsection (a)(1)(A)(ii) on the date 

17 the enrollee attempted to obtain the provider’s net18 work status) that the enrollee relied on the informa19 tion described in subsection (a)(1), if the provider’s 

20 network status or directory information on such di21 rectory was incorrect at the time the treatment or 

22 services involved was provided. 

23 ‘‘(2) REFUNDS TO ENROLLEES.—If a health 

24 care provider submits a bill to an enrollee in viola25 tion of paragraph (1), and the enrollee pays such 


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1 bill, the provider shall reimburse the enrollee for the 

2 full amount paid by the enrollee in excess of the in3 network cost-sharing amount for the treatment or 

4 services involved, plus interest, at an interest rate 

5 determined by the Secretary. 

6 ‘‘(c) PROVIDER BUSINESS PROCESSES.—A health 

7 care provider shall have in place business processes to en8 sure the timely provision of provider directory information 

9 to a group health plan or a health insurance issuer offer10 ing group or individual health insurance coverage to sup11 port compliance by such plans or issuers with subsection 

12 (a)(1). Such providers shall submit provider directory in13 formation to a plan or issuers, at a minimum— 

14 ‘‘(1) when the provider begins a network agree15 ment with a plan or with an issuer with respect to 

16 certain coverage; 

17 ‘‘(2) when the provider terminates a network 

18 agreement with a plan or with an issuer with respect 

19 to certain coverage; 

20 ‘‘(3) when there are material changes to the 

21 content of provider directory information described 

22 in subsection (a)(1); and 

23 ‘‘(4) every 90 days throughout the duration of 

24 the network agreement with a plan or issuer. 

25 ‘‘(d) ENFORCEMENT.— 


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1 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

2 health care provider that violates a requirement 

3 under subsection (c) or takes actions that prevent a 

4 group health plan or health insurance issuer from 

5 complying with subsection (a)(1) or (b) shall be sub6 ject to a civil monetary penalty of not more than 

7 $10,000 for each act constituting such violation. 

8 ‘‘(2) SAFE HARBOR.—The Secretary may waive 

9 the penalty described under paragraph (1) with re10 spect to a health care provider that unknowingly vio11 lates subsection (b)(1) with respect to an enrollee if 

12 such provider rescinds the bill involved and, if appli13 cable, reimburses the enrollee within 30 days of the 

14 date on which the provider billed the enrollee in vio15 lation of such subsection. 

16 ‘‘(3) PROCEDURE.—The provisions of section 

17 1128A of the Social Security Act, other than sub18 sections (a) and (b) and the first sentence of sub19 section (c)(1) of such section, shall apply to civil 

20 money penalties under this subsection in the same 

21 manner as such provisions apply to a penalty or pro22 ceeding under section 1128A of the Social Security 

23 Act. 

24 ‘‘(e) SAVINGS CLAUSE.—Nothing in this section shall 

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1 tract, or contract termination, with a group health plan 

2 or health insurance issuer— 

3 ‘‘(1) that the plan or issuer remove, at the time 

4 of termination of such contract, the provider from a 

5 directory of the plan or issuer described in sub6 section (a)(1); or 

7 ‘‘(2) that the plan or issuer bear financial re8 sponsibility, including under subsection (b), for pro9 viding inaccurate network status information to an 

10 enrollee. 

11 ‘‘(f) DEFINITION.—For purposes of this section, the 

12 term ‘provider directory information’ includes the names, 

13 addresses, specialty, and telephone numbers of individual 

14 health care providers, and the names, addresses, and tele15 phone numbers of each medical group, clinic, or facility 

16 contracted to participate in any of the networks of the 

17 group health plan or health insurance coverage involved. 

18 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec19 tion shall be construed to preempt any provision of State 

20 law relating to health care provider directories or network 

21 adequacy.’’. 

22 SEC. 305. TIMELY BILLS FOR PATIENTS. 

23 (a) IN GENERAL.— 


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1 (1) AMENDMENT.—Part P of title III of the 

2 Public Health Service Act (42 U.S.C. 280g et seq.) 

3 is amended by adding at the end the following: 

4 ‘‘SEC. 399V–7. TIMELY BILLS FOR PATIENTS. 

5 ‘‘(a) IN GENERAL.—The Secretary shall require— 

6 ‘‘(1) health care facilities, or in the case of 

7 practitioners providing services outside of such a fa8 cility, practitioners, to provide to patients a list of 

9 services rendered during the visit to such facility or 

10 practitioner, and, in the case of a facility, the name 

11 of the provider for each such service, upon discharge 

12 or by postal or electronic communication as soon as 

13 practicable and not later than 5 calendar days after 

14 discharge; and 

15 ‘‘(2) health care facilities and practitioners to 

16 send all adjudicated bills to the patient as soon as 

17 practicable, but not later than 45 calendar days 

18 after discharge. 

19 ‘‘(b) PAYMENT AFTER BILLING.—No patient may be 

20 required to pay a bill for health care services any earlier 

21 than 30 calendar days after receipt of a bill for such serv22 ices. 

23 ‘‘(c) EFFECT OF VIOLATION.— 

24 ‘‘(1) NOTIFICATION AND REFUND REQUIRE25 MENTS.— 


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1 ‘‘(A) PROVIDER LISTS.—If a facility or 

2 practitioner fails to provide a patient a list as 

3 required under subsection (a)(1), such facility 

4 or practitioner shall report such failure to the 

5 Secretary. 

6 ‘‘(B) BILLING.—If a facility or practitioner 

7 bills a patient after the 45-calendar-day period 

8 described in subsection (a)(2), such facility or 

9 practitioner shall— 

10 ‘‘(i) report such bill to the Secretary; 

11 and 

12 ‘‘(ii) refund the patient for the full 

13 amount paid in response to such bill with 

14 interest, at a rate determined by the Sec15 retary. 

16 ‘‘(2) CIVIL MONETARY PENALTIES.— 

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

18 impose civil monetary penalties of up to 

19 $10,000 a day on any facility or practitioner 

20 that— 

21 ‘‘(i) fails to provide a list required 

22 under subsection (a)(1) more than 10 

23 times, beginning on the date of such tenth 

24 failure; 


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1 ‘‘(ii) submits more than 10 bills out2 side of the period described in subsection 

3 (a)(2), beginning on the date on which 

4 such facility or practitioner sends the tenth 

5 such bill; 

6 ‘‘(iii) fails to report to the Secretary 

7 any failure to provide lists as required 

8 under paragraph (1)(A), beginning on the 

9 date that is 45 calendar days after dis10 charge; or 

11 ‘‘(iv) fails to send any bill as required 

12 under subsection (a)(2), beginning on the 

13 date that is 45 calendar days after the 

14 date of discharge or visit, as applicable. 

15 ‘‘(B) PROCEDURE.—The provisions of sec16 tion 1128A of the Social Security Act, other 

17 than subsections (a) and (b) and the first sen18 tence of subsection (c)(1) of such section, shall 

19 apply to civil money penalties under this sub20 section in the same manner as such provisions 

21 apply to a penalty or proceeding under section 

22 1128A of the Social Security Act. 

23 ‘‘(3) SAFE HARBOR.—The Secretary may ex24 empt a practitioner or facility from the penalties 

25 under paragraph (2)(A) or extend the period of time 


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1 specified under subsection (a)(2) for compliance with 

2 such subsection if a practitioner or facility— 

3 ‘‘(A) makes a good faith attempt to send 

4 a bill within 30 days but is unable to do so be5 cause of an incorrect address; or 

6 ‘‘(B) experiences extenuating circumstan7 ces (as defined by the Secretary), such as a 

8 hurricane or cyberattack, that may reasonably 

9 delay delivery of a timely bill.’’. 

10 (2) RULEMAKING.—Not later than 1 year after 

11 the date of enactment of this Act, the Secretary 

12 shall promulgate final regulations to define the term 

13 ‘‘extenuating circumstance’’ for purposes of section 

14 399V–7(c)(3)(B) of the Public Health Service Act, 

15 as added by paragraph (1). 

16 (b) GROUP HEALTH PLAN AND HEALTH INSURANCE

17 ISSUER REQUIREMENTS.—Subpart II of part A of title 

18 XXVII of the Public Health Service Act (42 U.S.C. 

19 300gg–11), as amended by section 304, is further amend20 ed by adding to the end the following: 

21 ‘‘SEC. 2729D. TIMELY BILLS FOR PATIENTS. 

22 ‘‘(a) IN GENERAL.—A group health plan or health 

23 insurance issuer offering group or individual health insur24 ance coverage shall have in place business practices with 

25 respect to in-network facilities and practitioners to ensure 


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1 that claims are adjudicated in order to facilitate facility 

2 and practitioner compliance with the requirements under 

3 section 399V–7(a). 

4 ‘‘(b) CLARIFICATION.—Nothing in subsection (a) pro5 hibits a provider and a group health plan or health insur6 ance issuer from establishing in a contract the timeline 

7 for submission by either party to the other party of billing 

8 information, adjudication, sending of remittance informa9 tion, or any other coordination required between the pro10 vider and the plan or issuer necessary for meeting the 

11 deadline described in section 399V–7(a)(2).’’. 

12 (c) EFFECTIVE DATE.—The amendments made by 

13 subsections (a) and (b) shall take effect 6 months after 

14 the date of enactment of this Act. 

15 SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BEN16 EFIT MANAGER SERVICES. 

17 Subpart II of part A of title XXVII of the Public 

18 Health Service Act (42 U.S.C. 300gg–11 et seq.), as 

19 amended by section 305, is further amended by adding 

20 at the end the following: 

21 ‘‘SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY 

22 BENEFIT MANAGER SERVICES. 

23 ‘‘(a) IN GENERAL.—A group health plan or health 

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1 macy benefits management services shall not enter into 

2 a contract with a drug manufacturer, distributor, whole3 saler, subcontractor, rebate aggregator, or any associated 

4 third party that limits the disclosure of information to 

5 plan sponsors in such a manner that prevents the plan 

6 or coverage, or an entity or subsidiary providing pharmacy 

7 benefits management services on behalf of a plan or cov8 erage from making the reports described in subsection (b). 

9 ‘‘(b) REPORTS TO GROUP PLAN SPONSORS.— 

10 ‘‘(1) IN GENERAL.—Beginning with the first 

11 plan year that begins after the date of enactment of 

12 the Lower Health Care Costs Act, not less fre13 quently than once per plan quarter, a health insur14 ance issuer offering group health insurance coverage 

15 or an entity providing pharmacy benefits manage16 ment services on behalf of a group health plan shall 

17 submit to the plan sponsor (as defined in section 

18 3(16)(B) of the Employee Retirement Income Secu19 rity Act of 1974) of such group health plan or 

20 health insurance coverage a report in accordance 

21 with this subsection and make such report available 

22 to the plan sponsor in a machine-readable format. 

23 Each such report shall include, with respect to the 

24 applicable group health plan or health insurance cov25 erage— 


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1 ‘‘(A) information collected from drug man2 ufacturers by such issuer or entity on the total 

3 amount of copayment assistance dollars paid, or 

4 copayment cards applied, that were funded by 

5 the drug manufacturer with respect to the en6 rollees in such plan or coverage; 

7 ‘‘(B) a list of each covered drug dispensed 

8 during the reporting period, including, with re9 spect to each such drug during the reporting 

10 period— 

11 ‘‘(i) the brand name, chemical entity, 

12 and National Drug Code; 

13 ‘‘(ii) the number of enrollees for 

14 whom the drug was filled during the plan 

15 year, the total number of prescription fills 

16 for the drug (including original prescrip17 tions and refills), and the total number of 

18 dosage units of the drug dispensed across 

19 the plan year, including whether the dis20 pensing channel was by retail, mail order, 

21 or specialty pharmacy; 

22 ‘‘(iii) the wholesale acquisition cost, 

23 listed as cost per days supply and cost per 

24 pill, or in the case of a drug in another 

25 form, per dose; 


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1 ‘‘(iv) the total out-of-pocket spending 

2 by enrollees on such drug, including en3 rollee spending through copayments, coin4 surance, and deductibles; and 

5 ‘‘(v) for any drug for which gross 

6 spending of the group health plan or 

7 health insurance coverage exceeded 

8 $10,000 during the reporting period— 

9 ‘‘(I) a list of all other available 

10 drugs in the same therapeutic cat11 egory or class, including brand name 

12 drugs and biological products and ge13 neric drugs or biosimilar biological 

14 products that are in the same thera15 peutic category or class; and 

16 ‘‘(II) the rationale for preferred 

17 formulary placement of a particular 

18 drug or drugs in that therapeutic cat19 egory or class; 

20 ‘‘(C) a list of each therapeutic category or 

21 class of drugs that were dispensed under the 

22 health plan or health insurance coverage during 

23 the reporting period, and, with respect to each 

24 such therapeutic category or class of drugs, 

25 during the reporting period— 


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1 ‘‘(i) total gross spending by the plan, 

2 before manufacturer rebates, fees, or other 

3 manufacturer remuneration; 

4 ‘‘(ii) the number of enrollees who 

5 filled a prescription for a drug in that cat6 egory or class; 

7 ‘‘(iii) if applicable to that category or 

8 class, a description of the formulary tiers 

9 and utilization mechanisms (such as prior 

10 authorization or step therapy) employed 

11 for drugs in that category or class; 

12 ‘‘(iv) the total out-of-pocket spending 

13 by enrollees, including enrollee spending 

14 through copayments, coinsurance, and 

15 deductibles; and 

16 ‘‘(v) for each therapeutic category or 

17 class under which three or more drugs are 

18 marketed and available— 

19 ‘‘(I) the amount received, or ex20 pected to be received, from drug man21 ufacturers in rebates, fees, alternative 

22 discounts, or other remuneration— 

23 ‘‘(aa) to be paid by drug 

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1 curred during the reporting pe2 riod; or 

3 ‘‘(bb) that is related to utili4 zation of drugs, in such thera5 peutic category or class; 

6 ‘‘(II) the total net spending by 

7 the health plan or health insurance 

8 coverage on that category or class of 

9 drugs; and 

10 ‘‘(III) the net price per dosage 

11 unit or course of treatment incurred 

12 by the health plan or health insurance 

13 coverage and its enrollees, after man14 ufacturer rebates, fees, and other re15 muneration for drugs dispensed within 

16 such therapeutic category or class 

17 during the reporting period; 

18 ‘‘(D) total gross spending on prescription 

19 drugs by the plan or coverage during the re20 porting period, before rebates and other manu21 facturer fees or remuneration; 

22 ‘‘(E) total amount received, or expected to 

23 be received, by the health plan or health insur24 ance coverage in drug manufacturer rebates, 

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1 neration received from the manufacturer or any 

2 third party related to utilization of drug or 

3 drug spending under that health plan or health 

4 insurance coverage during the reporting period; 

5 ‘‘(F) the total net spending on prescription 

6 drugs by the health plan or health insurance 

7 coverage during the reporting period; and 

8 ‘‘(G) amounts paid directly or indirectly in 

9 rebates, fees, or any other type of remuneration 

10 to brokers, consultants, advisors, or any other 

11 individual or firm who referred the group health 

12 plan’s or health insurance issuer’s business to 

13 the pharmacy benefit manager. 

14 ‘‘(2) PRIVACY REQUIREMENTS.—Health insur15 ance issuers offering group health insurance cov16 erage and entities providing pharmacy benefits man17 agement services on behalf of a group health plan 

18 shall provide information under paragraph (1) in a 

19 manner consistent with the privacy, security, and 

20 breach notification regulations promulgated under 

21 section 264(c) of the Health Insurance Portability 

22 and Accountability Act of 1996 (or successor regula23 tions), and shall restrict the use and disclosure of 

24 such information according to such privacy regula25 tions. 


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1 ‘‘(3) DISCLOSURE AND REDISCLOSURE.— 

2 ‘‘(A) LIMITATION TO BUSINESS ASSOCI3 ATES.—A group health plan receiving a report 

4 under paragraph (1) may disclose such informa5 tion only to business associates of such plan as 

6 defined in section 160.103 of title 45, Code of 

7 Federal Regulations (or successor regulations). 

8 ‘‘(B) CLARIFICATION REGARDING PUBLIC

9 DISCLOSURE OF INFORMATION.—Nothing in 

10 this section prevents a health insurance issuer 

11 offering group health insurance coverage or an 

12 entity providing pharmacy benefits management 

13 services on behalf of a group health plan from 

14 placing reasonable restrictions on the public dis15 closure of the information contained in a report 

16 described in paragraph (1). 

17 ‘‘(c) LIMITATIONS ON SPREAD PRICING.— 

18 ‘‘(1) PRESCRIPTION DRUG TRANSACTIONS WITH

19 PHARMACIES INDEPENDENT OF THE ISSUER OR

20 PHARMACY BENEFITS MANAGER.—If the pharmacy 

21 that dispenses a prescription drug to an enrollee in 

22 a group health plan or group or individual health in23 surance coverage is not wholly or partially owned by 

24 such plan, such issuer, or an entity providing phar25 macy benefit management services under such plan 


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1 or coverage, such plan, issuer, or entity shall not 

2 charge the plan, issuer, or enrollee a price for such 

3 prescription drug that exceeds the price paid to the 

4 pharmacy, excluding penalties paid by pharmacies to 

5 such plan, issuer, or entity. 

6 ‘‘(2) INTRA-COMPANY PRESCRIPTION DRUG

7 TRANSACTIONS.—If the mail order, specialty, or re8 tail pharmacy that dispenses a prescription drug to 

9 an enrollee in a group health plan or health insur10 ance coverage is wholly or partially owned by such 

11 health insurance issuer or an entity providing phar12 macy benefit management services under a group 

13 health plan or group or individual health insurance 

14 coverage, the price charged for such drug by such 

15 pharmacy to such group health plan or health insur16 ance issuer offering group or individual health insur17 ance coverage may not exceed the lesser of— 

18 ‘‘(A) the wholesale acquisition cost of the 

19 drug paid by the pharmacy, plus clearly docu20 mented dispensing costs, including pharmacy 

21 profit; or 

22 ‘‘(B) the median price charged to the 

23 group health plan or health insurance issuer 

24 when the same drug is dispensed to enrollees in 

25 the plan or coverage by other similarly situated 


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1 pharmacies not wholly or partially owned by the 

2 health insurance issuer or entity providing 

3 pharmacy benefits management services, as de4 scribed in paragraph (1). 

5 ‘‘(3) SUPPLEMENTARY REPORTING FOR INTRA6 COMPANY PRESCRIPTION DRUG TRANSACTIONS.—A 

7 health insurance issuer of group health insurance 

8 coverage or an entity providing pharmacy benefits 

9 management services under a group health plan or 

10 group health insurance coverage that conducts 

11 transactions with a wholly or partially owned phar12 macy, as described in paragraph (2), shall submit, 

13 together with the report under subsection (b), a sup14 plementary quarterly report to the plan sponsor that 

15 includes— 

16 ‘‘(A) an explanation of any benefit design 

17 parameters that encourage enrollees in the plan 

18 or coverage to fill prescriptions at mail order, 

19 specialty, or retail pharmacies that are wholly 

20 or partially owned by that issuer or entity; 

21 ‘‘(B) the percentage of total prescriptions 

22 charged to the plan, coverage, or enrollees in 

23 the plan or coverage, that were dispensed by 

24 mail order, specialty, or retail pharmacies that 

25 are wholly or partially owned by the issuer or 


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1 entity providing pharmacy benefits management 

2 services; and 

3 ‘‘(C) a list of all drugs dispensed by such 

4 wholly or partially owned pharmacy and 

5 charged to the plan or coverage, or enrollees of 

6 the plan or coverage, during the applicable 

7 quarter, and, with respect to each drug— 

8 ‘‘(i) the amount charged per dosage 

9 unit or course of treatment with respect to 

10 enrollees in the plan or coverage, including 

11 amounts charged to the plan or coverage 

12 and amounts charged to the enrollee; 

13 ‘‘(ii) the median amount charged to 

14 the plan or coverage, per dosage unit or 

15 course of treatment, and including 

16 amounts paid by the enrollee, when the 

17 same drug is dispensed by other phar18 macies that are not wholly or partially 

19 owned by the issuer or entity and that are 

20 included in the pharmacy network of that 

21 plan or coverage; 

22 ‘‘(iii) the interquartile range of the 

23 costs, per dosage unit or course of treat24 ment, and including amounts paid by the 

25 enrollee, when the same drug is dispensed 


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1 by other pharmacies that are not wholly or 

2 partially owned by the issuer or entity and 

3 that are included in the pharmacy network 

4 of that plan or coverage; and 

5 ‘‘(iv) the lowest cost per dosage unit 

6 or course of treatment, for such drug, in7 cluding amounts charged to the plan or 

8 issuer and enrollee, that is available from 

9 any pharmacy included in the network of 

10 the plan or coverage. 

11 ‘‘(d) FULL REBATE PASS-THROUGH TO PLAN.— 

12 ‘‘(1) IN GENERAL.—A pharmacy benefits man13 ager, a third-party administrator of a group health 

14 plan, a health insurance issuer offering group health 

15 insurance coverage, or an entity providing pharmacy 

16 benefits management services under such health 

17 plan or health insurance coverage shall remit 100 

18 percent of rebates, fees, alternative discounts, and 

19 all other remuneration received from a pharma20 ceutical manufacturer, distributor or any other third 

21 party, that are related to utilization of drugs under 

22 such health plan or health insurance coverage, to the 

23 group health plan. 


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1 ‘‘(2) FORM AND MANNER OF REMITTANCE.— 

2 Such rebates, fees, alternative discounts, and other 

3 remuneration shall be— 

4 ‘‘(A) remitted to the group health plan in 

5 a timely fashion after the period for which such 

6 rebates, fees, or other remuneration is cal7 culated, and in no case later than 90 days after 

8 the end of such period; 

9 ‘‘(B) fully disclosed and enumerated to the 

10 group health plan sponsor, as described in 

11 (b)(1); and 

12 ‘‘(C) available for audit by the plan spon13 sor, or a third-party designated by a plan spon14 sor no less than once per plan year. 

15 ‘‘(e) ENFORCEMENT.— 

16 ‘‘(1) FAILURE TO PROVIDE TIMELY INFORMA17 TION.—A health insurance issuer or an entity pro18 viding pharmacy benefit management services that 

19 violates subsection (a), fails to provide information 

20 required under subsection (b), engages in spread 

21 pricing as defined in subsection (c), or fails to com22 ply with the requirements of subsection (d), or a 

23 drug manufacturer that fails to provide information 

24 under subsection (b)(1)(A), in a timely manner shall 

25 be subject to a civil monetary penalty in the amount 


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1 of $10,000 for each day during which such violation 

2 continues or such information is not disclosed or re3 ported. 

4 ‘‘(2) FALSE INFORMATION.—A health insurance 

5 issuer, entity providing pharmacy benefit manage6 ment services, or drug manufacturer that knowingly 

7 provides false information under this section shall be 

8 subject to a civil money penalty in an amount not 

9 to exceed $100,000 for each item of false informa10 tion. Such civil money penalty shall be in addition to 

11 other penalties as may be prescribed by law. 

12 ‘‘(3) PROCEDURE.—The provisions of section 

13 1128A of the Social Security Act, other than sub14 sections (a) and (b) and the first sentence of sub15 section (c)(1) of such section shall apply to civil 

16 monetary penalties under this subsection in the 

17 same manner as such provisions apply to a penalty 

18 or proceeding under section 1128A of the Social Se19 curity Act. 

20 ‘‘(f) DEFINITIONS.—In this section— 

21 ‘‘(1) the term ‘similarly situated pharmacy’ 

22 means, with respect to a particular pharmacy, an23 other pharmacy that is approximately the same size 

24 (as measured by the number of prescription drugs 

25 dispensed), and that serves patients in the same geoVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00123 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 graphical area, whether through physical locations or 

2 mail order; and 

3 ‘‘(2) the term ‘wholesale acquisition cost’ has 

4 the meaning given such term in section 

5 1847A(c)(6)(B) of the Social Security Act.’’. 

6 SEC. 307. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 

7 ON PROFIT- AND REVENUE-SHARING IN 

8 HEALTH CARE. 

9 (a) STUDY.—Not later than 1 year after the date of 

10 enactment of this Act, the Comptroller General of the 

11 United States shall conduct a study to— 

12 (1) describe what is known about profit- and 

13 revenue-sharing relationships in the commercial 

14 health care markets, including those relationships 

15 that— 

16 (A) involve one or more— 

17 (i) physician groups that practice 

18 within a hospital included in the profit- or 

19 revenue-sharing relationship, or refer pa20 tients to such hospital; 

21 (ii) laboratory, radiology, or pharmacy 

22 services that are delivered to privately in23 sured patients of such hospital; 

24 (iii) surgical services; 


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1 (iv) hospitals or group purchasing or2 ganizations; or 

3 (v) rehabilitation or physical therapy 

4 facilities or services; and 

5 (B) include revenue- or profit-sharing 

6 whether through a joint venture, management 

7 or professional services agreement, or other 

8 form of gain-sharing contract; 

9 (2) describe Federal oversight of such relation10 ships, including authorities of the Department of 

11 Health and Human Services and the Federal Trade 

12 Commission to review such relationships and their 

13 potential to increase costs for patients, and identify 

14 limitations in such oversight; and 

15 (3) as appropriate, make recommendations to 

16 improve Federal oversight of such relationships. 

17 (b) REPORT.—Not later than 1 year after the date 

18 of enactment of this Act, the Comptroller General of the 

19 United States shall prepare and submit a report on the 

20 study conducted under subsection (a) to the Committee 

21 on Health, Education, Labor, and Pensions of the Senate 

22 and the Committee on Education and Labor and the Com23 mittee on Energy and Commerce of the House of Rep24 resentatives. 


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1 SEC. 308. DISCLOSURE OF DIRECT AND INDIRECT COM2 PENSATION FOR BROKERS AND CONSULT3 ANTS TO EMPLOYER-SPONSORED HEALTH 

4 PLANS AND ENROLLEES IN PLANS ON THE IN5 DIVIDUAL MARKET. 

6 (a) GROUP HEALTH PLANS.—Section 408(b)(2) of 

7 the Employee Retirement Income Security Act of 1974 

8 (29 U.S.C. 1108(b)(2)) is amended— 

9 (1) by striking ‘‘(2) Contracting or making’’ 

10 and inserting ‘‘(2)(A) Contracting or making’’; and 

11 (2) by adding at the end the following: 

12 ‘‘(B)(i) No contract or arrangement for services 

13 between a covered plan and a covered service pro14 vider, and no extension or renewal of such a contract 

15 or arrangement, is reasonable within the meaning of 

16 this paragraph unless the requirements of this 

17 clause are met. 

18 ‘‘(ii)(I) For purposes of this subparagraph: 

19 ‘‘(aa) The term ‘covered plan’ means a 

20 group health plan as defined section 733(a). 

21 ‘‘(bb) The term ‘covered service provider’ 

22 means a service provider that enters into a con23 tract or arrangement with the covered plan and 

24 reasonably expects $1,000 (or such amount as 

25 the Secretary may establish in regulations to 

26 account for inflation since the date of enactVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ment of the Lower Health Care Costs Act, as 

2 appropriate) or more in compensation, direct or 

3 indirect, to be received in connection with pro4 viding one or more of the following services, 

5 pursuant to the contract or arrangement, re6 gardless of whether such services will be per7 formed, or such compensation received, by the 

8 covered service provider, an affiliate, or a sub9 contractor: 

10 ‘‘(AA) Brokerage services, for which 

11 the covered service provider, an affiliate, or 

12 a subcontractor reasonably expects to re13 ceive indirect compensation or direct com14 pensation described in item (dd), provided 

15 to a covered plan with respect to selection 

16 of insurance products (including vision and 

17 dental), recordkeeping services, medical 

18 management vendor, benefits administra19 tion (including vision and dental), stop-loss 

20 insurance, pharmacy benefit management 

21 services, wellness services, transparency 

22 tools and vendors, group purchasing orga23 nization preferred vendor panels, disease 

24 management vendors and products, compli25 ance services, employee assistance proVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00127 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 grams, or third-party administration serv2 ices. 

3 ‘‘(BB) Consulting, for which the cov4 ered service provider, an affiliate, or a sub5 contractor reasonably expects to receive in6 direct compensation or direct compensation 

7 described in item (dd), related to the devel8 opment or implementation of plan design, 

9 insurance or insurance product selection 

10 (including vision and dental), record11 keeping, medical management, benefits ad12 ministration selection (including vision and 

13 dental), stop-loss insurance, pharmacy ben14 efit management services, wellness design 

15 and management services, transparency 

16 tools, group purchasing organization agree17 ments and services, participation in and 

18 services from preferred vendor panels, dis19 ease management, compliance services, em20 ployee assistance programs, or third-party 

21 administration services. 

22 ‘‘(cc) The term ‘affiliate’, with respect to a 

23 covered service provider, means an entity that 

24 directly or indirectly (through one or more 

25 intermediaries) controls, is controlled by, or is 


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1 under common control with, such provider, or is 

2 an officer, director, or employee of, or partner 

3 in, such provider. 

4 ‘‘(dd)(AA) The term ‘compensation’ means 

5 anything of monetary value, but does not in6 clude non-monetary compensation valued at 

7 $250 (or such amount as the Secretary may es8 tablish in regulations to account for inflation 

9 since the date of enactment of the Lower 

10 Health Care Costs Act, as appropriate) or less, 

11 in the aggregate, during the term of the con12 tract or arrangement. 

13 ‘‘(BB) The term ‘direct compensation’ 

14 means compensation received directly from a 

15 covered plan. 

16 ‘‘(CC) The term ‘indirect compensation’ 

17 means compensation received from any source 

18 other than the covered plan, the plan sponsor, 

19 the covered service provider, or an affiliate. 

20 Compensation received from a subcontractor is 

21 indirect compensation, unless it is received in 

22 connection with services performed under a con23 tract or arrangement with a subcontractor. 

24 ‘‘(ee) The term ‘responsible plan fiduciary’ 

25 means a fiduciary with authority to cause the 


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1 covered plan to enter into, or extend or renew, 

2 the contract or arrangement. 

3 ‘‘(ff) The term ‘subcontractor’ means any 

4 person or entity (or an affiliate of such person 

5 or entity) that is not an affiliate of the covered 

6 service provider and that, pursuant to a con7 tract or arrangement with the covered service 

8 provider or an affiliate, reasonably expects to 

9 receive $1,000 (or such amount as the Sec10 retary may establish in regulations to account 

11 for inflation since the date of enactment of the 

12 Lower Health Care Costs Act, as appropriate) 

13 or more in compensation for performing one or 

14 more services described in item (bb) under a 

15 contract or arrangement with the covered plan. 

16 ‘‘(II) For purposes of this subparagraph, a de17 scription of compensation or cost may be expressed 

18 as a monetary amount, formula, or a per capita 

19 charge for each enrollee or, if the compensation or 

20 cost cannot reasonably be expressed in such terms, 

21 by any other reasonable method, including a disclo22 sure that additional compensation may be earned 

23 but may not be calculated at the time of contract if 

24 such a disclosure includes a description of the cir25 cumstances under which the additional compensation 


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1 may be earned and a reasonable and good faith esti2 mate if the covered service provider cannot otherwise 

3 readily describe compensation or cost and explains 

4 the methodology and assumptions used to prepare 

5 such estimate. Any such description shall contain 

6 sufficient information to permit evaluation of the 

7 reasonableness of the compensation or cost. 

8 ‘‘(III) No person or entity is a ‘covered service 

9 provider’ within the meaning of subclause (I)(bb) 

10 solely on the basis of providing services as an affil11 iate or a subcontractor that is performing one or 

12 more of the services described in subitem (AA) or 

13 (BB) of such subclause under the contract or ar14 rangement with the covered plan. 

15 ‘‘(iii) A covered service provider shall disclose to 

16 a responsible plan fiduciary, in writing, the fol17 lowing: 

18 ‘‘(I) A description of the services to be pro19 vided to the covered plan pursuant to the con20 tract or arrangement. 

21 ‘‘(II) If applicable, a statement that the 

22 covered service provider, an affiliate, or a sub23 contractor will provide, or reasonably expects to 

24 provide, services pursuant to the contract or arVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00131 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 rangement directly to the covered plan as a fi2 duciary (within the meaning of section 3(21)). 

3 ‘‘(III) A description of all direct compensa4 tion, either in the aggregate or by service, that 

5 the covered service provider, an affiliate, or a 

6 subcontractor reasonably expects to receive in 

7 connection with the services described in sub8 clause (I). 

9 ‘‘(IV)(aa) A description of all indirect com10 pensation that the covered service provider, an 

11 affiliate, or a subcontractor reasonably expects 

12 to receive in connection with the services de13 scribed in subclause (I)— 

14 ‘‘(AA) including compensation from a 

15 vendor to a brokerage firm based on a 

16 structure of incentives not solely related to 

17 the contract with the covered plan; and 

18 ‘‘(BB) not including compensation re19 ceived by an employee from an employer 

20 on account of work performed by the em21 ployee. 

22 ‘‘(bb) A description of the arrangement be23 tween the payer and the covered service pro24 vider, an affiliate, or a subcontractor, as appliVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 cable, pursuant to which such indirect com2 pensation is paid. 

3 ‘‘(cc) Identification of the services for 

4 which the indirect compensation will be re5 ceived, if applicable. 

6 ‘‘(dd) Identification of the payer of the in7 direct compensation. 

8 ‘‘(V) A description of any compensation 

9 that will be paid among the covered service pro10 vider, an affiliate, or a subcontractor, in con11 nection with the services described in subclause 

12 (I) if such compensation is set on a transaction 

13 basis (such as commissions, finder’s fees, or 

14 other similar incentive compensation based on 

15 business placed or retained), including identi16 fication of the services for which such com17 pensation will be paid and identification of the 

18 payers and recipients of such compensation (in19 cluding the status of a payer or recipient as an 

20 affiliate or a subcontractor), regardless of 

21 whether such compensation also is disclosed 

22 pursuant to subclause (III) or (IV). 

23 ‘‘(VI) A description of any compensation 

24 that the covered service provider, an affiliate, or 

25 a subcontractor reasonably expects to receive in 


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1 connection with termination of the contract or 

2 arrangement, and how any prepaid amounts 

3 will be calculated and refunded upon such ter4 mination. 

5 ‘‘(iv) A covered service provider shall disclose to 

6 a responsible plan fiduciary, in writing a description 

7 of the manner in which the compensation described 

8 in clause (iii), as applicable, will be received. 

9 ‘‘(v)(I) A covered service provider shall disclose 

10 the information required under clauses (iii) and (iv) 

11 to the responsible plan fiduciary not later than the 

12 date that is reasonably in advance of the date on 

13 which the contract or arrangement is entered into, 

14 and extended or renewed. 

15 ‘‘(II) A covered service provider shall disclose 

16 any change to the information required under 

17 clauses (iii) and (iv) as soon as practicable, but not 

18 later than 60 days from the date on which the cov19 ered service provider is informed of such change, un20 less such disclosure is precluded due to extraor21 dinary circumstances beyond the covered service pro22 vider’s control, in which case the information shall 

23 be disclosed as soon as practicable. 

24 ‘‘(vi)(I) Upon the written request of the respon25 sible plan fiduciary or covered plan administrator, a 


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1 covered service provider shall furnish any other in2 formation relating to the compensation received in 

3 connection with the contract or arrangement that is 

4 required for the covered plan to comply with the re5 porting and disclosure requirements under this Act. 

6 ‘‘(II) The covered service provider shall disclose 

7 the information required under clause (iii)(I) reason8 ably in advance of the date upon which such respon9 sible plan fiduciary or covered plan administrator 

10 states that it is required to comply with the applica11 ble reporting or disclosure requirement, unless such 

12 disclosure is precluded due to extraordinary cir13 cumstances beyond the covered service provider’s 

14 control, in which case the information shall be dis15 closed as soon as practicable. 

16 ‘‘(vii) No contract or arrangement will fail to be 

17 reasonable under this subparagraph solely because 

18 the covered service provider, acting in good faith and 

19 with reasonable diligence, makes an error or omis20 sion in disclosing the information required pursuant 

21 to clause (iii) (or a change to such information dis22 closed pursuant to clause (v)(II)) or clause (vi), pro23 vided that the covered service provider discloses the 

24 correct information to the responsible plan fiduciary 

25 as soon as practicable, but not later than 30 days 


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1 from the date on which the covered service provider 

2 knows of such error or omission. 

3 ‘‘(viii)(I) Pursuant to subsection (a), subpara4 graphs (C) and (D) of section 406(a)(1) shall not 

5 apply to a responsible plan fiduciary, notwithstand6 ing any failure by a covered service provider to dis7 close information required under clause (iii), if the 

8 following conditions are met: 

9 ‘‘(aa) The responsible plan fiduciary did 

10 not know that the covered service provider 

11 failed or would fail to make required disclosures 

12 and reasonably believed that the covered service 

13 provider disclosed the information required to 

14 be disclosed. 

15 ‘‘(bb) The responsible plan fiduciary, upon 

16 discovering that the covered service provider 

17 failed to disclose the required information, re18 quests in writing that the covered service pro19 vider furnish such information. 

20 ‘‘(cc) If the covered service provider fails 

21 to comply with a written request described in 

22 subclause (II) within 90 days of the request, 

23 the responsible plan fiduciary notifies the Sec24 retary of the covered service provider’s failure, 

25 in accordance with subclauses (II) and (III). 


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1 ‘‘(II) A notice described in subclause (I)(cc) 

2 shall contain— 

3 ‘‘(aa) the name of the covered plan; 

4 ‘‘(bb) the plan number used for the annual 

5 report on the covered plan; 

6 ‘‘(cc) the plan sponsor’s name, address, 

7 and employer identification number; 

8 ‘‘(dd) the name, address, and telephone 

9 number of the responsible plan fiduciary; 

10 ‘‘(ee) the name, address, phone number, 

11 and, if known, employer identification number 

12 of the covered service provider; 

13 ‘‘(ff) a description of the services provided 

14 to the covered plan; 

15 ‘‘(gg) a description of the information that 

16 the covered service provider failed to disclose; 

17 ‘‘(hh) the date on which such information 

18 was requested in writing from the covered serv19 ice provider; and 

20 ‘‘(ii) a statement as to whether the covered 

21 service provider continues to provide services to 

22 the plan. 

23 ‘‘(III) A notice described in subclause (I)(cc) 

24 shall be filed with the Department not later than 30 

25 days following the earlier of— 


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1 ‘‘(aa) the covered service provider’s refusal 

2 to furnish the information requested by the 

3 written request described in subclause (I)(bb); 

4 or 

5 ‘‘(bb) 90 days after the written request re6 ferred to in subclause (I)(cc) is made. 

7 ‘‘(IV) If the covered service provider fails to 

8 comply with the written request under subclause 

9 (I)(bb) within 90 days of such request, the respon10 sible plan fiduciary shall determine whether to ter11 minate or continue the contract or arrangement 

12 under section 404. If the requested information re13 lates to future services and is not disclosed promptly 

14 after the end of the 90-day period, the responsible 

15 plan fiduciary shall terminate the contract or ar16 rangement as expeditiously as possible, consistent 

17 with such duty of prudence. 

18 ‘‘(ix) Nothing in this subparagraph shall be 

19 construed to supersede any provision of State law 

20 that governs disclosures by parties that provide the 

21 services described in this section, except to the ex22 tent that such law prevents the application of a re23 quirement of this section.’’. 

24 (b) APPLICABILITY OF EXISTING REGULATIONS.— 

25 Nothing in the amendments made by subsection (a) shall 


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•S 1895 IS

1 be construed to affect the applicability of section 

2 2550.408b–2 of title 29, Code of Federal Regulations (or 

3 any successor regulations), with respect to any applicable 

4 entity other than a covered plan or a covered service pro5 vider (as defined in section 408(b)(2)(B)(ii) of the Em6 ployee Retirement Income Security Act of 1974, as 

7 amended by subsection (a)). 

8 (c) INDIVIDUAL MARKET COVERAGE.—Subpart 1 of 

9 part B of title XVII of the Public Health Service Act (42 

10 U.S.C. 300gg–41 et seq.) is amended by adding at the 

11 end the following: 

12 ‘‘SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL 

13 MARKET COVERAGE. 

14 ‘‘(a) IN GENERAL.—A health insurance issuer offer15 ing individual health insurance coverage shall make disclo16 sures to enrollees in such coverage, as described in sub17 section (b), and reports to the Secretary, as described in 

18 subsection (c), regarding direct or indirect compensation 

19 provided to an agent or broker associated with enrolling 

20 individuals in such coverage. 

21 ‘‘(b) DISCLOSURE.—A health insurance issuer de22 scribed in subsection (a) shall disclose to an enrollee the 

23 amount of direct or indirect compensation provided to an 

24 agent or broker for services provided by such agent or 


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•S 1895 IS

1 broker associated with plan selection and enrollment. Such 

2 disclosure shall be— 

3 ‘‘(1) made prior to the individual finalizing plan 

4 selection; and 

5 ‘‘(2) included on any documentation confirming 

6 the individual’s enrollment. 

7 ‘‘(c) REPORTING.—A health insurance issuer de8 scribed in subsection (a) shall report to the Secretary any 

9 direct or indirect compensation provided to an agent or 

10 broker associated with enrolling individuals in such cov11 erage. 

12 ‘‘(d) RULEMAKING.—Not later than 1 year after the 

13 date of enactment of the Lower Health Care Costs Act, 

14 the Secretary shall finalize, through notice-and-comment 

15 rulemaking, the form and manner in which issuers de16 scribed in subsection (a) are required to make the disclo17 sures described in subsection (b) and the reports described 

18 in subsection (c).’’. 

19 (d) TRANSITION RULE.—No contract executed prior 

20 to the effective date described in subsection (e) by a group 

21 health plan subject to the requirements of section 

22 408(b)(2)(B) of the Employee Retirement Income Secu23 rity Act of 1974 (as amended by subsection (a)) or by 

24 a health insurance issuer subject to the requirements of 

25 section 2746 of the Public Health Service Act (as added 


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•S 1895 IS

1 by subsection (c)) shall be subject to the requirements of 

2 such section 408(b)(2)(B) or such section 2746, as appli3 cable. 

4 (e) EFFECTIVE DATE.—The amendments made by 

5 subsections (a) and (c) shall take effect 2 years after the 

6 date of enactment of this Act. 

7 SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING 

8 INFORMATION. 

9 (a) IN GENERAL.—Subpart II of part A of title 

10 XXVII of the Public Health Service Act (42 U.S.C. 

11 300gg–11 et seq.), as amended by section 306, is further 

12 amended by adding at the end the following: 

13 ‘‘SEC. 2729F. PROVISION OF COST-SHARING INFORMATION. 

14 ‘‘(a) PROVIDER DISCLOSURES.—A provider that is 

15 in-network with respect to a group health plan or a health 

16 insurance issuer offering group or individual health insur17 ance coverage shall provide to an enrollee in the plan or 

18 coverage who submits a request for the information de19 scribed in paragraph (1) or (2), together with accurate 

20 and complete information about the enrollee’s coverage 

21 under the applicable plan or coverage— 

22 ‘‘(1) as soon as practicable and not later than 

23 2 business days after the enrollee requests such in24 formation, a good faith estimate of the expected en25 rollee cost-sharing for the provision of a particular 


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1 health care service (including any service that is rea2 sonably expected to be provided in conjunction with 

3 such specific service); and 

4 ‘‘(2) as soon as practicable and not later than 

5 2 business days after an enrollee requests such in6 formation, the contact information for any ancillary 

7 providers for a scheduled health care service. 

8 ‘‘(b) INSURER DISCLOSURES.—A group health plan 

9 or a health insurance issuer offering group or individual 

10 health insurance coverage shall provide an enrollee in the 

11 plan or coverage with a good faith estimate of the enroll12 ee’s cost-sharing (including deductibles, copayments, and 

13 coinsurance) for which the enrollee would be responsible 

14 for paying with respect to a specific health care service 

15 (including any service that is reasonably expected to be 

16 provided in conjunction with such specific service), as soon 

17 as practicable and not later than 2 business days after 

18 receiving a request for such information by an enrollee. 

19 ‘‘(c) ENFORCEMENT.— 

20 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

21 health care provider that violates a requirement 

22 under subsection (a) shall be subject to a civil mone23 tary penalty of not more than $10,000 for each act 

24 constituting such violation. 


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1 ‘‘(2) PROCEDURE.—The provisions of section 

2 1128A of the Social Security Act, other than sub3 sections (a) and (b) and the first sentence of sub4 section (c)(1) of such section, shall apply to civil 

5 money penalties under this subsection in the same 

6 manner as such provisions apply to a penalty or pro7 ceeding under section 1128A of the Social Security 

8 Act.’’. 

9 (b) EFFECTIVE DATE.—Section 2729G of the Public 

10 Health Service Act, as added by subsection (a), shall apply 

11 with respect to plan years beginning on or after January 

12 1, 2021. 

13 SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH 

14 AND SUBSTANCE USE DISORDER BENEFITS. 

15 Section 2726 of the Public Health Service Act (42 

16 U.S.C. 300gg–26) is amended— 

17 (1) in subsection (a), by adding at the end the 

18 following: 

19 ‘‘(8) COMPLIANCE REQUIREMENTS.— 

20 ‘‘(A) NONQUANTITATIVE TREATMENT LIM21 ITATION (NQTL) REQUIREMENTS.—In the case 

22 of a group health plan or a health insurance 

23 issuer offering group or individual health insur24 ance coverage that provides both medical and 

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1 stance use disorder benefits, the plan or cov2 erage shall perform comparative analyses about 

3 the design and application of nonquantitative 

4 treatment limitations (referred to in this para5 graph as the ‘NQTL’) in accordance with the 

6 following process, and make available to the 

7 Secretary upon request within 60 days begin8 ning January 1, 2020, and within 30 days be9 ginning January 1, 2021, the following infor10 mation: 

11 ‘‘(i) The specific plan or coverage lan12 guage regarding the NQTL, that applies to 

13 such plan or coverage, and a description of 

14 all mental health or substance use disorder 

15 and medical/surgical services to which it 

16 applies in each respective benefits classi17 fication. 

18 ‘‘(ii) The factors used to determine 

19 that an NQTL will apply to mental health 

20 or substance use disorder benefits and 

21 medical/surgical benefits. 

22 ‘‘(iii) The evidentiary standard (both 

23 identified and deidentified) for the factors 

24 identified in clause (ii) and any other evi25 dence relied upon to design and apply the 


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1 NQTL to mental health or substance use 

2 disorder benefits and medical/surgical ben3 efits. 

4 ‘‘(iv) The comparative analyses dem5 onstrating that the processes and strate6 gies used to design the NQTL, as written 

7 and in operation, and the as written proc8 esses and strategies used to apply the 

9 NQTL for mental health or substance use 

10 disorder benefits are comparable to, and 

11 are applied no more stringently than, the 

12 processes and strategies used to design the 

13 NQTL, as written and in operation, and 

14 the as written processes and strategies 

15 used to apply the NQTL to medical/sur16 gical benefits. 

17 ‘‘(v) A disclosure of the specific find18 ings and conclusions reached by the plan 

19 or coverage that the results of the analyses 

20 described in this subparagraph indicate 

21 that the plan or coverage is in compliance 

22 with this section. 

23 ‘‘(B) SECRETARY REQUEST PROCESS.— 

24 ‘‘(i) SUBMISSION UPON COMPLAINT.— 

25 The Secretary shall request that a group 


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1 health plan or a health insurance issuer of2 fering group or individual health insurance 

3 coverage submit the comparative analyses 

4 described in subparagraph (A) if the Sec5 retary has received any complaints from 

6 plan participants or participating providers 

7 about such a plan or coverage that involve 

8 mental health or substance use disorder 

9 benefits. 

10 ‘‘(ii) RANDOM SUBMISSIONS.—The 

11 Secretary shall request the comparative 

12 analyses described in subparagraph (A) 

13 from no fewer than 50 plans or coverages 

14 selected at random, annually, and such 

15 plans or coverages shall not— 

16 ‘‘(I) be the same plans or cov17 erages for which the comparative 

18 analyses are requested under clause 

19 (i); 

20 ‘‘(II) be the same plan or cov21 erage being investigated by the De22 partment regarding NQTLs or that 

23 has been investigated by the Depart24 ment regarding NQTLs within the 

25 last 5 years; and 


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1 ‘‘(III) be the same plan or cov2 erage that has been selected under 

3 clause (i) or (ii) within the last 5 

4 years. 

5 ‘‘(iii) ADDITIONAL INFORMATION.—In 

6 instances in which the Secretary has con7 cluded that the plan or coverage has not 

8 submitted sufficient information for the 

9 Secretary to review the comparative anal10 yses described in subparagraph (A), as re11 quested under clauses (i) and (ii), the Sec12 retary shall specify to the plan or coverage 

13 the information the plan or coverage must 

14 submit to be responsive to the request 

15 under clauses (i) and (ii) for the Secretary 

16 to review the comparative analyses de17 scribed in subparagraph (A) for compliance 

18 with this section. 

19 ‘‘(iv) REQUIRED ACTION.—In in20 stances in which the Secretary has re21 viewed the comparative analyses described 

22 in subparagraph (A), as requested under 

23 clauses (i) and (ii), and determined that 

24 the plan or coverage is not in compliance 

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1 fy to the plan or coverage the actions the 

2 plan or coverage must take to be in compli3 ance with this section. Documents or com4 munications produced in connection with 

5 the Secretary’s recommendations to the 

6 plan or coverage shall not be subject to 

7 disclosure pursuant to section 552 of title 

8 5, United States Code. 

9 ‘‘(v) REPORT.—Not later than 1 year 

10 after the date of enactment of this para11 graph, and annually thereafter, the Sec12 retary shall submit to the Committee on 

13 Education and Labor of the House of Rep14 resentatives and the Committee on Health, 

15 Education, Labor, and Pensions of the 

16 Senate a report that contains— 

17 ‘‘(I) each of the comparative 

18 analyses requested under clauses (i) 

19 and (ii), except that the identity of 

20 each plan or coverage and any con21 tracted entity of a plan or coverage 

22 shall be redacted; 

23 ‘‘(II) the Secretary’s conclusions 

24 as to whether each plan or coverage 

25 submitted sufficient information for 


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1 the Secretary to review the compara2 tive analyses requested under clauses 

3 (i) and (ii) for compliance with this 

4 section; 

5 ‘‘(III) for each plan or coverage 

6 that did submit sufficient information 

7 for the Secretary to review the com8 parative analyses requested under 

9 clause (i), the Secretary’s conclusions 

10 as to whether and why the plan or 

11 coverage is in compliance with this 

12 section; 

13 ‘‘(IV) the Secretary’s specifica14 tions described in clause (iii) for each 

15 plan or coverage that the Secretary 

16 determined did not submit sufficient 

17 information for the Secretary to re18 view the comparative analyses re19 quested under clauses (i) and (ii) for 

20 compliance with this section; and 

21 ‘‘(V) the Secretary’s specifica22 tions described in clause (iv) of the 

23 actions each plan or coverage that the 

24 Secretary determined is not in compli25 ance with this section must take to be 


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1 in compliance with this section, in2 cluding the reason why the Secretary 

3 determined the plan or coverage is not 

4 in compliance. 

5 ‘‘(C) COMPLIANCE PROGRAM GUIDANCE

6 DOCUMENT UPDATE PROCESS.— 

7 ‘‘(i) IN GENERAL.—The Secretary 

8 shall include select instances of noncompli9 ance that the Secretary discovers upon re10 viewing the comparative analyses requested 

11 under clauses (i) and (ii) of subparagraph 

12 (B) in the compliance program guidance 

13 document described in section 2726(a)(6), 

14 as it is updated every 2 years, except that 

15 all instances shall be deidentified and such 

16 instances shall not disclose any protected 

17 health information or individually identifi18 able information. 

19 ‘‘(ii) GUIDANCE AND REGULATIONS.— 

20 Not later than 18 months after the date of 

21 enactment of this paragraph, the Secretary 

22 shall finalize any draft or interim guidance 

23 and regulations relating to mental health 

24 parity under this section. 


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1 ‘‘(iii) STATE.—Any instances of non2 compliance the Secretary discovers upon 

3 reviewing the comparative analyses re4 quested under clauses (i) and (ii) of sub5 paragraph (B) shall be shared with a State 

6 for coverage offered by a health insurance 

7 issuer in the group market, in accordance 

8 with section 2726(a)(6)(B)(iii)(II).’’. 

9 SEC. 311. TECHNICAL AMENDMENTS. 

10 (a) ERISA.—Section 715 of the Employee Retire11 ment Income Security Act of 1974 (29 U.S.C. 1185d) is 

12 amended— 

13 (1) in subsection (a)(1), by striking ‘‘(as 

14 amended by the Patient Protection and Affordable 

15 Care Act)’’ and inserting ‘‘(including any subsequent 

16 amendments to such part)’’; and 

17 (2) in subsection (b)— 

18 (A) by striking ‘‘(as amended by the Pa19 tient Protection and Affordable Care Act)’’ and 

20 inserting ‘‘(including any subsequent amend21 ments to such part)’’; and 

22 (B) by striking ‘‘(as so amended)’’. 

23 (b) IRC.—Section 9815 of the Internal Revenue 

24 Code of 1986 is amended— 


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1 (1) in subsection (a)(1), by striking ‘‘(as 

2 amended by the Patient Protection and Affordable 

3 Care Act)’’ and inserting ‘‘(including any subsequent 

4 amendments to such part)’’; and 

5 (2) in subsection (b)— 

6 (A) by striking ‘‘(as amended by the Pa7 tient Protection and Affordable Care Act)’’ and 

8 inserting ‘‘(including any subsequent amend9 ments to such part)’’; and 

10 (B) by striking ‘‘(as so amended)’’. 

11 (c) APPLICABILITY.—The amendments made by sub12 sections (a) and (b) shall take effect as though included 

13 in the enactment of the Patient Protection and Affordable 

14 Care Act (Public Law 111–148). 

15 SEC. 312. THIRD-PARTY ADMINISTRATORS. 

16 Any obligation on a third-party administrator under 

17 this Act (including the amendments made by this Act) 

18 shall not affect any other direct or indirect requirement 

19 under any other provision of Federal law that applies to 

20 third-party administrators offering services to group 

21 health plans. 


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1 TITLE IV—IMPROVING PUBLIC 

2 HEALTH 

3 SEC. 401. IMPROVING AWARENESS OF DISEASE PREVEN4 TION. 

5 The Public Health Service Act is amended by striking 

6 section 313 of such Act (42 U.S.C. 245) and inserting 

7 the following: 

8 ‘‘SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPOR9 TANCE OF VACCINATIONS. 

10 ‘‘(a) IN GENERAL.—The Secretary, acting through 

11 the Director of the Centers for Disease Control and Pre12 vention and in coordination with other offices and agen13 cies, as appropriate, shall award competitive grants to one 

14 or more public or private entities to carry out a national, 

15 evidence-based campaign to increase awareness and 

16 knowledge of the safety and effectiveness of vaccines for 

17 the prevention and control of diseases, combat misin18 formation about vaccines, and disseminate scientific and 

19 evidence-based vaccine-related information, with the goal 

20 of increasing rates of vaccination across all ages, as appli21 cable, particularly in communities with low rates of vac22 cination, to reduce and eliminate vaccine-preventable dis23 eases. 

24 ‘‘(b) CONSULTATION.—In carrying out the campaign 

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1 priate public health and medical experts, including the Na2 tional Academy of Medicine and medical and public health 

3 associations and nonprofit organizations, in the develop4 ment, implementation, and evaluation of the evidence5 based public awareness campaign. 

6 ‘‘(c) REQUIREMENTS.—The campaign under this sec7 tion shall— 

8 ‘‘(1) be a national, evidence-based initiative; 

9 ‘‘(2) include the development of resources for 

10 communities with low rates of vaccination, including 

11 culturally and linguistically appropriate resources, as 

12 applicable; 

13 ‘‘(3) include the dissemination of vaccine infor14 mation and communication resources to public 

15 health departments, health care providers, and 

16 health care facilities, including such providers and 

17 facilities that provide prenatal and pediatric care; 

18 ‘‘(4) be complementary to, and coordinated 

19 with, any other Federal, State, or local efforts, as 

20 appropriate; and 

21 ‘‘(5) assess the effectiveness of communication 

22 strategies to increase rates of vaccination. 

23 ‘‘(d) ADDITIONAL ACTIVITIES.—The campaign under 

24 this section may— 


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1 ‘‘(1) include the use of television, radio, the 

2 internet, and other media and telecommunications 

3 technologies; 

4 ‘‘(2) be focused to address specific needs of 

5 communities and populations with low rates of vac6 cination; and 

7 ‘‘(3) include the dissemination of scientific and 

8 evidence-based vaccine-related information, such 

9 as— 

10 ‘‘(A) advancements in evidence-based re11 search related to diseases that may be pre12 vented by vaccines and vaccine development; 

13 ‘‘(B) information on vaccinations for indi14 viduals and communities, including individuals 

15 for whom vaccines are not recommended by the 

16 Advisory Committee for Immunization Prac17 tices, and the effects of low vaccination rates 

18 within a community on such individuals; 

19 ‘‘(C) information on diseases that may be 

20 prevented by vaccines; and 

21 ‘‘(D) information on vaccine safety and the 

22 systems in place to monitor vaccine safety. 

23 ‘‘(e) EVALUATION.—The Secretary shall— 


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1 ‘‘(1) establish benchmarks and metrics to quan2 titatively measure and evaluate the awareness cam3 paign under this section; 

4 ‘‘(2) conduct qualitative assessments regarding 

5 the awareness campaign under this section; and 

6 ‘‘(3) prepare and submit to the Committee on 

7 Health, Education, Labor, and Pensions of the Sen8 ate and the Committee on Energy and Commerce of 

9 the House of Representatives an evaluation of the 

10 awareness campaign under this section. 

11 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated to carry out this section 

13 and section 317(k) such sums as may be necessary for 

14 fiscal years 2020 through 2024.’’. 

15 SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE 

16 DISEASES. 

17 Section 317(k)(1) of the Public Health Service Act 

18 (42 U.S.C. 247b(k)(1)) is amended— 

19 (1) in subparagraph (C), by striking ‘‘; and’’ 

20 and inserting a semicolon; 

21 (2) in subparagraph (D), by striking the period 

22 and inserting a semicolon; and 

23 (3) by adding at the end the following: 


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1 ‘‘(E) planning, implementation, and evaluation 

2 of activities to address vaccine-preventable diseases, 

3 including activities to— 

4 ‘‘(i) identify communities at high risk of 

5 outbreaks related to vaccine-preventable dis6 eases, including through improved data collec7 tion and analysis; 

8 ‘‘(ii) pilot innovative approaches to improve 

9 vaccination rates in communities and among 

10 populations with low rates of vaccination; 

11 ‘‘(iii) reduce barriers to accessing vaccines 

12 and evidence-based information about the 

13 health effects of vaccines; 

14 ‘‘(iv) partner with community organiza15 tions and health care providers to develop and 

16 deliver evidence-based interventions, including 

17 culturally and linguistically appropriate inter18 ventions, to increase vaccination rates; 

19 ‘‘(v) improve delivery of evidence-based 

20 vaccine-related information to parents and oth21 ers; and 

22 ‘‘(vi) improve the ability of State, local, 

23 tribal, and territorial public health departments 

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1 breaks related to vaccine-preventable diseases; 

2 and 

3 ‘‘(F) research related to strategies for improv4 ing awareness of scientific and evidence-based vac5 cine-related information, including for communities 

6 with low rates of vaccination, in order to understand 

7 barriers to vaccination, improve vaccination rates, 

8 and assess the public health outcomes of such strate9 gies.’’. 

10 SEC. 403. GUIDE ON EVIDENCE-BASED STRATEGIES FOR 

11 PUBLIC HEALTH DEPARTMENT OBESITY PRE12 VENTION PROGRAMS. 

13 (a) DEVELOPMENT AND DISSEMINATION OF AN EVI14 DENCE-BASED STRATEGIES GUIDE.—The Secretary of 

15 Health and Human Services (referred to in this section 

16 as the ‘‘Secretary’’), acting through the Director of the 

17 Centers for Disease Control and Prevention, not later than 

18 2 years after the date of enactment of this Act, shall— 

19 (1) develop a guide on evidence-based strategies 

20 for State, territorial, and local health departments to 

21 use to build and maintain effective obesity preven22 tion and reduction programs, and, in consultation 

23 with stakeholders that have expertise in Tribal 

24 health, a guide on such evidence-based strategies 

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1 tions for such Indian Tribes and Tribal organiza2 tions to use for such purpose, both of which guides 

3 shall— 

4 (A) describe an integrated program struc5 ture for implementing interventions proven to 

6 be effective in preventing and reducing the inci7 dence of obesity; and 

8 (B) recommend— 

9 (i) optimal resources, including staff10 ing and infrastructure, for promoting nu11 trition and obesity prevention and reduc12 tion; and 

13 (ii) strategies for effective obesity pre14 vention programs for State and local 

15 health departments, Indian Tribes, and 

16 Tribal organizations, including strategies 

17 related to— 

18 (I) the application of evidence19 based and evidence-informed practices 

20 to prevent and reduce obesity rates; 

21 (II) the development, implemen22 tation, and evaluation of obesity pre23 vention and reduction strategies for 

24 specific communities and populations; 


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1 (III) demonstrated knowledge of 

2 obesity prevention practices that re3 duce associated preventable diseases, 

4 health conditions, death, and health 

5 care costs; 

6 (IV) best practices for the coordi7 nation of efforts to prevent and re8 duce obesity and related chronic dis9 eases; 

10 (V) addressing the underlying 

11 risk factors and social determinants of 

12 health that impact obesity rates; and 

13 (VI) interdisciplinary coordina14 tion between relevant public health of15 ficials specializing in fields such as 

16 nutrition, physical activity, epidemi17 ology, communications, and policy im18 plementation, and collaboration be19 tween public health officials and com20 munity-based organizations; and 

21 (2) disseminate the guides and current re22 search, evidence-based practices, tools, and edu23 cational materials related to obesity prevention, con24 sistent with the guide, to State and local health de25 partments, Indian Tribes, and Tribal organizations. 


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1 (b) TECHNICAL ASSISTANCE.—The Secretary, acting 

2 through the Director of the Centers for Disease Control 

3 and Prevention, shall provide technical assistance to State 

4 and local health departments, Indian Tribes, and Tribal 

5 organizations to support such health departments in im6 plementing the guide developed under subsection (a)(1). 

7 (c) INDIAN TRIBES; TRIBAL ORGANIZATIONS.—The 

8 terms ‘‘Indian Tribe’’ and ‘‘Tribal organization’’ have the 

9 meanings given the terms ‘‘Indian tribe’’ and ‘‘tribal orga10 nization’’, respectively, in section 4 of the Indian Self-De11 termination and Education Assistance Act (25 U.S.C. 

12 5304). 

13 SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES. 

14 Title III of the Public Health Service Act is amended 

15 by inserting after section 330M (42 U.S.C. 254c–19) the 

16 following: 

17 ‘‘SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUT18 COMES. 

19 ‘‘(a) DEFINITIONS.—In this section: 

20 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en21 tity’ means an entity providing health care services 

22 in rural areas, frontier areas, health professional 

23 shortage areas, or medically underserved areas, or to 

24 medically underserved populations or Native Ameri25 cans, including Indian tribes or tribal organizations. 


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1 ‘‘(2) HEALTH PROFESSIONAL SHORTAGE

2 AREA.—The term ‘health professional shortage area’ 

3 means a health professional shortage area des4 ignated under section 332. 

5 ‘‘(3) INDIAN TRIBE.—The terms ‘Indian tribe’ 

6 and ‘tribal organization’ have the meanings given 

7 such terms in section 4 of the Indian Self-Deter8 mination and Education Assistance Act. 

9 ‘‘(4) MEDICALLY UNDERSERVED POPU10 LATION.—The term ‘medically underserved popu11 lation’ has the meaning given the term in section 

12 330(b)(3). 

13 ‘‘(5) NATIVE AMERICANS.—The term ‘Native 

14 Americans’ has the meaning given such term in sec15 tion 736 and includes Indian tribes and tribal orga16 nizations. 

17 ‘‘(6) TECHNOLOGY-ENABLED COLLABORATIVE

18 LEARNING AND CAPACITY BUILDING MODEL.—The 

19 term ‘technology-enabled collaborative learning and 

20 capacity building model’ means a distance health 

21 education model that connects specialists with mul22 tiple other health care professionals through simulta23 neous interactive videoconferencing for the purpose 

24 of facilitating case-based learning, disseminating 

25 best practices, and evaluating outcomes. 


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1 ‘‘(b) PROGRAM ESTABLISHED.—The Secretary shall, 

2 as appropriate, award grants to evaluate, develop, and, as 

3 appropriate, expand the use of technology-enabled collabo4 rative learning and capacity building models, to increase 

5 access to health care services, such as those to address 

6 chronic diseases and conditions, mental health, substance 

7 use disorders, prenatal and maternal health, pediatric 

8 care, pain management, palliative care, and other specialty 

9 care in medically underserved areas and for medically un10 derserved populations. 

11 ‘‘(c) USE OF FUNDS.— 

12 ‘‘(1) IN GENERAL.—Grants awarded under sub13 section (b) shall be used for— 

14 ‘‘(A) the development and acquisition of 

15 instructional programming, and the training of 

16 health care providers and other professionals 

17 that provide or assist in the provision of serv18 ices through such models; 

19 ‘‘(B) information collection and evaluation 

20 activities to study the impact of such models on 

21 patient outcomes and health care providers, and 

22 to identify best practices for the expansion and 

23 use of such models; or 


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1 ‘‘(C) other activities consistent with achiev2 ing the objectives of the grants awarded under 

3 this section, as determined by the Secretary. 

4 ‘‘(2) OTHER USES.—In addition to any of the 

5 uses under paragraph (1), grants awarded under 

6 subsection (b) may be used for— 

7 ‘‘(A) equipment to support the use and ex8 pansion of technology-enabled collaborative 

9 learning and capacity building models, including 

10 for hardware and software that enables distance 

11 learning, health care provider support, and the 

12 secure exchange of electronic health informa13 tion; or 

14 ‘‘(B) support for health care providers and 

15 other professionals that provide or assist in the 

16 provision of services through such models. 

17 ‘‘(d) LENGTH OF GRANTS.—Grants awarded under 

18 subsection (b) shall be for a period of up to 5 years. 

19 ‘‘(e) APPLICATION.—An eligible entity that seeks to 

20 receive a grant under subsection (b) shall submit to the 

21 Secretary an application, at such time, in such manner, 

22 and containing such information as the Secretary may re23 quire. Such application criteria shall include an assess24 ment of the effect of technology-enabled collaborative 


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1 learning and capacity building models on patient outcomes 

2 and health care providers. 

3 ‘‘(f) TECHNICAL ASSISTANCE.—The Secretary shall 

4 provide (either directly through the Department of Health 

5 and Human Services or by contract) technical assistance 

6 to eligible entities, including recipients of grants under 

7 subsection (b), on the development, use, and evaluation 

8 of technology-enabled collaborative learning and capacity 

9 building models in order to expand access to health care 

10 services provided by such entities, including for medically 

11 underserved areas and to medically underserved popu12 lations. 

13 ‘‘(g) REPORT BY SECRETARY.—Not later than 4 

14 years after the date of enactment of this section, the Sec15 retary shall prepare and submit to the Committee on 

16 Health, Education, Labor, and Pensions of the Senate and 

17 the Committee on Energy and Commerce of the House 

18 of Representatives, and post on the internet website of the 

19 Department of Health and Human Services, a report in20 cluding, at minimum— 

21 ‘‘(1) a description of any new and continuing 

22 grants awarded to entities under subsection (b) and 

23 the specific purpose and amounts of such grants; 

24 ‘‘(2) an overview of— 


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1 ‘‘(A) the evaluations conducted under sub2 sections (b) or (f); and 

3 ‘‘(B) technical assistance provided under 

4 subsection (f); and 

5 ‘‘(3) a description of any significant findings or 

6 developments in patient outcomes and health care 

7 providers and best practices for eligible entities ex8 panding, using, or evaluating technology-enabled col9 laborative learning and capacity building models. 

10 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

11 is authorized to be appropriated to carry out this section, 

12 such sums as may be necessary for each of fiscal years 

13 2020 through 2024.’’. 

14 SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION. 

15 Subtitle C of title XXVIII of the Public Health Serv16 ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add17 ing at the end the following: 

18 ‘‘SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZA19 TION GRANTS. 

20 ‘‘(a) IN GENERAL.—The Secretary, acting through 

21 the Director of the Centers for Disease Control and Pre22 vention, shall— 

23 ‘‘(1) award grants to State, local, Tribal, and 

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1 sion and modernization of public health data sys2 tems, to assist public health departments in— 

3 ‘‘(A) assessing current data infrastructure 

4 capabilities and gaps to improve and increase 

5 consistency in data collection, storage, analysis, 

6 and, as appropriate, to improve dissemination 

7 of public health-related information; 

8 ‘‘(B) improving secure public health data 

9 collection, transmission, exchange, maintenance, 

10 and analysis; 

11 ‘‘(C) simplifying and supporting reporting 

12 by health care providers, as applicable, pursu13 ant to State law, including through the use of 

14 health information technology, to State, local, 

15 Tribal, and territorial public health depart16 ments, including public health officials in mul17 tiple jurisdictions within such State, as appro18 priate; 

19 ‘‘(D) enhancing interoperability of public 

20 health data systems (including systems created 

21 or accessed by public health departments) with 

22 health information technology, including cer23 tified health information technology; 

24 ‘‘(E) supporting earlier disease and health 

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1 time data monitoring, to support rapid public 

2 health responses; and 

3 ‘‘(F) supporting activities within the appli4 cable jurisdiction related to the expansion and 

5 modernization of electronic case reporting; 

6 ‘‘(2) as appropriate, conduct activities related 

7 to the interoperability and improvement of applicable 

8 public health data systems used by the Centers for 

9 Disease Control and Prevention, and, in coordination 

10 with the Office of the National Coordinator for 

11 Health Information Technology, the designation of 

12 data and technology standards for health informa13 tion systems of the public health infrastructure with 

14 deference given to standards published by standards 

15 development organizations and voluntary consensus16 based standards bodies; and 

17 ‘‘(3) develop and utilize public-private partner18 ships for technical assistance and related implemen19 tation support for State, local, Tribal, and territorial 

20 public health departments, and the Centers for Dis21 ease Control and Prevention, on the expansion and 

22 modernization of electronic case reporting and public 

23 health data systems, as applicable. 

24 ‘‘(b) REQUIREMENTS.— 


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1 ‘‘(1) IN GENERAL.—The Secretary may not 

2 award a grant under subsection (a)(1) unless the ap3 plicant supports standards endorsed by the National 

4 Coordinator for Health Information Technology pur5 suant to section 3001(c)(1) or adopted by the Sec6 retary under section 3004. 

7 ‘‘(2) WAIVER.—The Secretary may waive the 

8 requirement under paragraph (1) with respect to an 

9 applicant if the Secretary determines that the activi10 ties under subsection (a) cannot otherwise be carried 

11 out within the applicable jurisdiction. 

12 ‘‘(3) APPLICATION.—A State, local, Tribal, or 

13 territorial health department applying for a grant 

14 under this section shall submit an application to the 

15 Secretary at such time and in such manner as the 

16 Secretary may require. Such application shall in17 clude information describing— 

18 ‘‘(A) the activities that will be supported 

19 by the grant; and 

20 ‘‘(B) how the modernization of such public 

21 health data systems will support or impact the 

22 public health infrastructure of the health de23 partment, including a description of remaining 

24 gaps, if any, and the actions needed to address 

25 such gaps. 


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1 ‘‘(c) USE OF FUNDS.—An entity receiving a grant 

2 under this section may use amounts received under such 

3 grant for one or both of the following: 

4 ‘‘(1) Carrying out activities described in sub5 section (a)(1) to support public health data systems 

6 (including electronic case reporting), which may in7 clude support for, and training of, professionals with 

8 expertise in contributing to and using such systems 

9 (including public health data scientists). 

10 ‘‘(2) Developing and disseminating information 

11 related to the use and importance of public health 

12 data. 

13 ‘‘(d) STRATEGY AND IMPLEMENTATION PLAN.—Not 

14 later than 180 days after the date of enactment of the 

15 Lower Health Care Costs Act, the Secretary, acting 

16 through the Director of the Centers for Disease Control 

17 and Prevention, shall submit to the Committee on Health, 

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

19 Committee on Energy and Commerce of the House of 

20 Representatives, a coordinated strategy and an accom21 panying implementation plan that identifies and dem22 onstrates the steps the Secretary will carry out to— 

23 ‘‘(1) update and improve applicable public 

24 health data systems used by the Centers for Disease 

25 Control and Prevention; and 


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1 ‘‘(2) carry out the activities described in this 

2 section to support the improvement of State, local, 

3 Tribal, and territorial public health data systems. 

4 ‘‘(e) CONSULTATION.—The Secretary, acting through 

5 the Director of the Centers for Disease Control and Pre6 vention, shall consult with State, local, Tribal, and terri7 torial health departments, professional medical and public 

8 health associations, associations representing hospitals or 

9 other health care entities, health information technology 

10 experts, and other appropriate entities regarding the plan 

11 and grant program to modernize public health data sys12 tems pursuant to this section. Such activities may include 

13 the provision of technical assistance related to the ex14 change of information by such public health data systems 

15 used by relevant health care and public health entities at 

16 the local, State, Federal, Tribal, and territorial levels. 

17 ‘‘(f) REPORT TO CONGRESS.—Not later than 1 year 

18 after the date of enactment of this section, the Secretary 

19 shall submit a report to the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate and the Com21 mittee on Energy and Commerce of the House of Rep22 resentatives that includes— 

23 ‘‘(1) a description of any barriers to— 


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1 ‘‘(A) public health authorities imple2 menting electronic case reporting and interoper3 able public health data systems; or 

4 ‘‘(B) the exchange of information pursuant 

5 to electronic case reporting; 

6 ‘‘(2) an assessment of the potential public 

7 health impact of implementing electronic case re8 porting and interoperable public health data sys9 tems; and 

10 ‘‘(3) a description of the activities carried out 

11 pursuant to this section. 

12 ‘‘(g) ELECTRONIC CASE REPORTING.—In this sec13 tion, the term ‘electronic case reporting’ means the auto14 mated identification, generation, and bilateral exchange of 

15 reports of health events among electronic health record or 

16 health information technology systems and public health 

17 authorities. 

18 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 

19 purpose of carrying out this section, there are authorized 

20 to be appropriated such sums as may be necessary for fis21 cal years 2020 through 2024.’’. 

22 SEC. 406. INNOVATION FOR MATERNAL HEALTH. 

23 (a) IN GENERAL.—The Secretary of Health and 

24 Human Services (referred to in this section as the ‘‘Sec25 retary’’), in consultation with experts representing a variVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00172 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ety of clinical specialties, State, tribal, or local public 

2 health officials, researchers, epidemiologists, statisticians, 

3 and community organizations, shall establish a program 

4 to award competitive grants to eligible entities for the pur5 pose of— 

6 (1) identifying, developing, or disseminating 

7 best practices to improve maternal health care qual8 ity and outcomes, eliminate preventable maternal 

9 mortality and severe maternal morbidity, and im10 prove infant health outcomes, which may include— 

11 (A) information on evidence-based prac12 tices to improve the quality and safety of ma13 ternal health care in hospitals and other health 

14 care settings of a State or health care system, 

15 including by addressing topics commonly associ16 ated with health complications or risks related 

17 to prenatal care, labor care, birthing, and post18 partum care; 

19 (B) best practices for improving maternal 

20 health care based on data findings and reviews 

21 conducted by a State maternal mortality review 

22 committee that address topics of relevance to 

23 common complications or health risks related to 

24 prenatal care, labor care, birthing, and postpar25 tum care; and 


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1 (C) information on addressing deter2 minants of health that impact maternal health 

3 outcomes for women before, during, and after 

4 pregnancy; 

5 (2) collaborating with State maternal mortality 

6 review committees to identify issues for the develop7 ment and implementation of evidence-based practices 

8 to improve maternal health outcomes and reduce 

9 preventable maternal mortality and severe maternal 

10 morbidity; 

11 (3) providing technical assistance and sup12 porting the implementation of best practices identi13 fied in paragraph (1) to entities providing health 

14 care services to pregnant and postpartum women; 

15 and 

16 (4) identifying, developing, and evaluating new 

17 models of care that improve maternal and infant 

18 health outcomes, which may include the integration 

19 of community-based services and clinical care. 

20 (b) ELIGIBLE ENTITIES.—To be eligible for a grant 

21 under subsection (a), an entity shall— 

22 (1) submit to the Secretary an application at 

23 such time, in such manner, and containing such in24 formation as the Secretary may require; and 


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1 (2) demonstrate in such application that the en2 tity has a demonstrated expertise in data-driven ma3 ternal safety and quality improvement initiatives in 

4 the areas of obstetrics and gynecology or maternal 

5 health. 

6 (c) AUTHORIZATION OF APPROPRIATIONS.—To carry 

7 out this section, there is authorized to be appropriated 

8 such sums as may be necessary for each of fiscal years 

9 2020 through 2024. 

10 SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS. 

11 Title VII of the Public Health Service Act is amended 

12 by striking section 763 (42 U.S.C. 294p) and inserting 

13 the following: 

14 ‘‘SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS. 

15 ‘‘(a) GRANT PROGRAM.—The Secretary shall estab16 lish a program to award grants to accredited schools of 

17 allopathic medicine, osteopathic medicine, and nursing, 

18 and other health professional training programs for the 

19 training of health care professionals to reduce and prevent 

20 discrimination (including training related to implicit bi21 ases) in the provision of health care services related to 

22 prenatal care, labor care, birthing, and postpartum care. 

23 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

24 subsection (a), an entity described in such subsection shall 

25 submit to the Secretary an application at such time, in 


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1 such manner, and containing such information as the Sec2 retary may require. 

3 ‘‘(c) REPORTING REQUIREMENT.—Each entity 

4 awarded a grant under this section shall periodically sub5 mit to the Secretary a report on the status of activities 

6 conducted using the grant, including a description of the 

7 impact of such training on patient outcomes, as applicable. 

8 ‘‘(d) BEST PRACTICES.—The Secretary may identify 

9 and disseminate best practices for the training of health 

10 care professionals to reduce and prevent discrimination 

11 (including training related to implicit biases) in the provi12 sion of health care services related to prenatal care, labor 

13 care, birthing, and postpartum care. 

14 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

15 carry out this section, there is authorized to be appro16 priated such sums as may be necessary for each of fiscal 

17 years 2020 through 2024.’’. 

18 SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT 

19 DISCRIMINATION. 

20 Not later than 2 years after date of enactment of this 

21 Act, the Secretary of Health and Human Services (re22 ferred to in this section as the ‘‘Secretary’’) shall, through 

23 a contract with an independent research organization, 

24 study and make recommendations for accredited schools 

25 of allopathic medicine, osteopathic medicine, and nursing, 


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1 and other health professional training programs on best 

2 practices related to training to reduce and prevent dis3 crimination, including training related to implicit biases, 

4 in the provision of health care services related to prenatal 

5 care, labor care, birthing, and postpartum care. 

6 SEC. 409. PERINATAL QUALITY COLLABORATIVES. 

7 Section 317K(a)(2) of the Public Health Service Act 

8 (42 U.S.C. 247b–12(a)(2)) is amended by adding at the 

9 end the following: 

10 ‘‘(E)(i) The Secretary, acting through the 

11 Director of the Centers for Disease Control and 

12 Prevention and in coordination with other of13 fices and agencies, as appropriate, shall estab14 lish or continue a competitive grant program 

15 for the establishment or support of perinatal 

16 quality collaboratives to improve perinatal care 

17 and perinatal health outcomes for pregnant and 

18 postpartum women and their infants. A State 

19 or Indian Tribe may use funds received through 

20 such grant to— 

21 ‘‘(I) support the use of evidence-based 

22 or evidence-informed practices to improve 

23 outcomes for maternal and infant health; 

24 ‘‘(II) work with clinical teams; ex25 perts; State, local, and, as appropriate, 


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1 tribal public health officials; and stake2 holders, including patients and families, to 

3 identify, develop, or disseminate best prac4 tices to improve perinatal care and out5 comes; and 

6 ‘‘(III) employ strategies that provide 

7 opportunities for health care professionals 

8 and clinical teams to collaborate across 

9 health care settings and disciplines, includ10 ing primary care and mental health, as ap11 propriate, to improve maternal and infant 

12 health outcomes, which may include the 

13 use of data to provide timely feedback 

14 across hospital and clinical teams to in15 form responses, and to provide support 

16 and training to hospital and clinical teams 

17 for quality improvement, as appropriate. 

18 ‘‘(ii) To be eligible for a grant under 

19 clause (i), an entity shall submit to the Sec20 retary an application in such form and manner 

21 and containing such information as the Sec22 retary may require.’’. 


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1 SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND 

2 POSTPARTUM WOMEN. 

3 (a) GRANTS.—Title III of the Public Health Service 

4 Act is amended by inserting after section 330N of such 

5 Act, as added by section 404, the following: 

6 ‘‘SEC. 330O. INTEGRATED SERVICES FOR PREGNANT AND 

7 POSTPARTUM WOMEN. 

8 ‘‘(a) IN GENERAL.—The Secretary may award grants 

9 for the purpose of establishing or operating evidence-based 

10 or innovative, evidence-informed programs to deliver inte11 grated health care services to pregnant and postpartum 

12 women to optimize the health of women and their infants, 

13 including to reduce adverse maternal health outcomes, 

14 pregnancy-related deaths, and related health disparities 

15 (including such disparities associated with racial and eth16 nic minority populations), and as appropriate, by address17 ing issues researched under subsection (b)(2) of section 

18 317K. 

19 ‘‘(b) INTEGRATED SERVICES FOR PREGNANT AND

20 POSTPARTUM WOMEN.— 

21 ‘‘(1) ELIGIBILITY.—To be eligible to receive a 

22 grant under subsection (a), a State or Indian Tribe 

23 (as defined in section 4 of the Indian Self-Deter24 mination and Education Assistance Act) shall work 

25 with relevant stakeholders that coordinate care (in26 cluding coordinating resources and referrals for 


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1 health care and social services) to develop and carry 

2 out the program, including— 

3 ‘‘(A) State, tribal, and local agencies re4 sponsible for Medicaid, public health, social 

5 services, mental health, and substance use dis6 order treatment and services; 

7 ‘‘(B) health care providers who serve preg8 nant women; and 

9 ‘‘(C) community-based health organiza10 tions and health workers, including providers of 

11 home visiting services and individuals rep12 resenting communities with disproportionately 

13 high rates of maternal mortality and severe ma14 ternal morbidity, and including those rep15 resenting racial and ethnicity minority popu16 lations. 

17 ‘‘(2) TERMS.— 

18 ‘‘(A) LIMITATION.—The Secretary may 

19 award a grant under subsection (a) to up to 10 

20 States. 

21 ‘‘(B) PERIOD.—A grant awarded under 

22 subsection (a) shall be made for a period of 5 

23 years. 

24 ‘‘(C) PRIORITIZATION.—In awarding 

25 grants under subsection (a), the Secretary shall 


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1 prioritize applications from States or Indian 

2 Tribes with the highest rates of maternal mor3 tality and severe maternal morbidity, and shall 

4 consider health disparities related to maternal 

5 mortality and severe maternal morbidity, in6 cluding such disparities associated with racial 

7 and ethnic minority populations. 

8 ‘‘(D) EVALUATION.—The Secretary shall 

9 require grantees to evaluate the outcomes of the 

10 programs supported under the grant. 

11 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated to carry out this section 

13 such sums as may be necessary for each of fiscal years 

14 2020 through 2024.’’. 

15 (b) REPORT ON GRANT OUTCOMES AND DISSEMINA16 TION OF BEST PRACTICES.— 

17 (1) REPORT.—Not later than April 1, 2025, the 

18 Secretary of Health and Human Services shall sub19 mit to the Committee on Health, Education, Labor, 

20 and Pensions of the Senate and the Committee on 

21 Energy and Commerce of the House of Representa22 tives a report that describes— 

23 (A) the outcomes of the activities sup24 ported by the grants awarded under the amendVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00181 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ments made by this section on maternal and 

2 child health; 

3 (B) best practices and models of care used 

4 by recipients of grants under such amendments; 

5 and 

6 (C) obstacles identified by recipients of 

7 grants under such amendments, and strategies 

8 used by such recipients to deliver care, improve 

9 maternal and child health, and reduce health 

10 disparities. 

11 (2) DISSEMINATION OF BEST PRACTICES.—Not 

12 later than October 1, 2025, the Secretary of Health 

13 and Human Services shall disseminate information 

14 on best practices and models of care used by recipi15 ents of grants under the amendments made by this 

16 section (including best practices and models of care 

17 relating to the reduction of health disparities, includ18 ing such disparities associated with racial and ethnic 

19 minority populations, in rates of maternal mortality 

20 and severe maternal morbidity) to relevant stake21 holders, which may include health providers, medical 

22 schools, nursing schools, relevant State, tribal, and 

23 local agencies, and the general public. 


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1 SEC. 411. EXTENSION FOR COMMUNITY HEALTH CENTERS, 

2 THE NATIONAL HEALTH SERVICE CORPS, 

3 AND TEACHING HEALTH CENTERS THAT OP4 ERATE GME PROGRAMS. 

5 (a) COMMUNITY HEALTH CENTERS FUNDING.—Sec6 tion 10503(b)(1)(F) of the Patient Protection and Afford7 able Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended 

8 by striking ‘‘fiscal year 2019’’ and inserting ‘‘each of fiscal 

9 years 2019 through 2024’’. 

10 (b) NATIONAL HEALTH SERVICE CORPS.—Section 

11 10503(b)(2)(F) of the Patient Protection and Affordable 

12 Care Act (42 U.S.C. 254b–2(b)(2)(F)) is amended by 

13 striking ‘‘and 2019’’ and inserting ‘‘through 2024’’. 

14 (c) TEACHING HEALTH CENTERS THAT OPERATE

15 GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 

16 340H(g)(1) of the Public Health Service Act (42 U.S.C. 

17 256h(g)(1)) is amended by striking ‘‘and 2019’’ and in18 serting ‘‘through 2024’’. 

19 (d) APPLICATION OF PROVISIONS.—Amounts appro20 priated pursuant to this section for each of fiscal years 

21 2019 through 2024 shall be subject to the requirements 

22 contained in Public Law 115–245 for funds for programs 

23 authorized under sections 330 through 340 of the Public 

24 Health Service Act. 

25 (e) CONFORMING AMENDMENTS.—Paragraph (4) of 

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1 ed by section 50901 of Public Law 115–123, is amended 

2 by striking ‘‘and section 50901(e) of the Advancing 

3 Chronic Care, Extenders, and Social Services Act’’ and in4 serting ‘‘, section 50901(e) of the Advancing Chronic 

5 Care, Extenders, and Social Services Act, and section 

6 411(d) of the Lower Health Care Costs Act’’. 

7 SEC. 412. OTHER PROGRAMS. 

8 (a) TYPE I.—Section 330B(b)(2)(D) of the Public 

9 Health Service Act (42 U.S.C. 254c–2(b)(2)(D)) is 

10 amended by striking ‘‘and 2019’’ and inserting ‘‘through 

11 2024’’. 

12 (b) INDIANS.—Subparagraph (D) of section 

13 330C(c)(2) of the Public Health Service Act (42 U.S.C. 

14 254c–3(c)(2)(D)) is amended by striking ‘‘and 2019’’ and 

15 inserting ‘‘through 2024’’. 

16 TITLE V—IMPROVING THE EX17 CHANGE OF HEALTH INFOR18 MATION 

19 SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, 

20 NETWORK, AND COST INFORMATION. 

21 (a) IN GENERAL.—Part A of title XXVII of the Pub22 lic Health Service Act (42 U.S.C. 300gg et seq.) is amend23 ed by inserting after section 2715A the following: 


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1 ‘‘SEC. 2715B. REQUIREMENT TO PROVIDE HEALTH CLAIMS, 

2 NETWORK, AND COST INFORMATION. 

3 ‘‘(a) IN GENERAL.—A group health plan or a health 

4 insurance issuer offering group or individual health insur5 ance coverage shall make available for access, exchange, 

6 or use without special effort, through application program7 ming interfaces (or successor technology or standards), 

8 the information described in subsection (b), in the manner 

9 described in subsection (b) and otherwise consistent with 

10 this section. 

11 ‘‘(b) INFORMATION.—The following information is re12 quired to be made available, in such form and manner as 

13 the Secretary may specify, as described in subsection (a): 

14 ‘‘(1) Historical claims, provider encounter, and 

15 payment data for each enrollee, which shall— 

16 ‘‘(A) include adjudicated medical and pre17 scription drug claims and equivalent encoun18 ters, including all data elements contained in 

19 such transactions— 

20 ‘‘(i) that were adjudicated by the 

21 group health plan or health insurance 

22 issuer during the previous 5 years or the 

23 enrollee’s entire period of enrollment in the 

24 applicable plan or coverage if such period 

25 is less than 5 years; 


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1 ‘‘(ii) that involve benefits managed by 

2 any third party, such as a pharmacy bene3 fits manager or radiology benefits manager 

4 that manages benefits or adjudicates 

5 claims on behalf of the plan or coverage; 

6 and 

7 ‘‘(iii) from any other health plan or 

8 health insurance coverage issued or admin9 istered by the same insurance issuer, in 

10 which the same enrollee was enrolled dur11 ing the previous 5 years; and 

12 ‘‘(B) be available— 

13 ‘‘(i) in a single, longitudinal format 

14 that is easy to understand and secure, and 

15 that may update automatically, including 

16 by using the standards adopted for imple17 mentation of section 3001(c)(5)(D)(iv); 

18 ‘‘(ii) as soon as practicable, and in no 

19 case later than the period of time deter20 mined by the Secretary, after the claim is 

21 adjudicated or the data is received by the 

22 health plan or health insurance issuer; and 

23 ‘‘(iii) to the enrollee, and any pro24 viders or third-party applications or serv25 ices authorized by the enrollee, for 5 years 


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1 after the end date of the enrollee’s enroll2 ment in the plan or in any coverage offered 

3 by the health insurance issuer. 

4 ‘‘(2) Identifying directory information for all in5 network providers, including facilities and practi6 tioners, that participate in the plan or coverage, 

7 which shall— 

8 ‘‘(A) include— 

9 ‘‘(i) the national provider identifier 

10 for in-network facilities and practitioners; 

11 and 

12 ‘‘(ii) the name, address, phone num13 ber, and specialty for each such facility 

14 and practitioner, based on the most recent 

15 interaction between the plan or coverage 

16 and that facility or practitioner; 

17 ‘‘(B) be capable of returning a list of par18 ticipating in-network facilities and practitioners, 

19 in a given specialty or at a particular facility 

20 type, within a specified geographic radius; and 

21 ‘‘(C) be capable of returning the network 

22 status, when presented with identifiers for a 

23 given enrollee and facility or practitioner. 

24 ‘‘(3) Estimated patient out-of-pocket costs, in25 cluding costs expected to be incurred through a deVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00187 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ductible, copayment, coinsurance, or other form of 

2 cost-sharing, for— 

3 ‘‘(A) a designated set of common services 

4 or episodes of care, to be established by the 

5 Secretary through rulemaking, including, at a 

6 minimum— 

7 ‘‘(i) in the case of services provided by 

8 a hospital, the 100 most common diag9 nosis-related groups, as used in the Medi10 care Inpatient Prospective Patient System 

11 (or successor episode-based reimbursement 

12 methodology) at that hospital, based on 

13 claims data adjudicated by the group 

14 health plan or health insurance issuer; 

15 ‘‘(ii) in the case of services provided 

16 in an outpatient setting, including radi17 ology, lab tests, and outpatient surgical 

18 procedures, any service rendered by the fa19 cility or practitioner, and reimbursed by 

20 the health plan or health insurance issuer; 

21 and 

22 ‘‘(iii) in the case of post-acute care, 

23 including home health providers, skilled 

24 nursing facilities, inpatient rehabilitation 

25 facilities, and long-term care hospitals, the 


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1 patient out-of-pocket costs for an episode 

2 of care, as the Secretary may determine, 

3 which permits users to reasonably compare 

4 costs across different facility and service 

5 types; and 

6 ‘‘(B) all prescription drugs currently in7 cluded on any tier of the formulary of the plan 

8 or coverage. 

9 ‘‘(c) AVAILABILITY AND ACCESS.—The application 

10 programming interfaces, including all data required to be 

11 made available through such interfaces, shall— 

12 ‘‘(1) be made available by the applicable group 

13 health plan or health insurance issuer, at no charge, 

14 to— 

15 ‘‘(A) enrollees in the group health plan or 

16 health insurance coverage; 

17 ‘‘(B) third parties authorized by the en18 rollee; 

19 ‘‘(C) facilities and practitioners who are 

20 under contract with the plan or coverage; and 

21 ‘‘(D) business associates of such facilities 

22 and practitioners, as defined in section 160.103 

23 of title 45, Code of Federal Regulations (or any 

24 successor regulations); 


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1 ‘‘(2) be available to enrollees in the group 

2 health plan or health insurance coverage, and to 

3 third-party applications or services facilitating such 

4 access by enrollees, during the enrollment process 

5 and for a minimum of 5 years after the end date of 

6 the enrollee’s enrollment in the plan or in any cov7 erage offered by the health insurance issuer; 

8 ‘‘(3) permit persistent access by third-party ap9 plications or services authorized by the enrollee, for 

10 a reasonable period of time, consistent with current 

11 security practices; 

12 ‘‘(4) employ the applicable content, vocabulary, 

13 and technical standards, including, as appropriate, 

14 such standards adopted by the Secretary pursuant 

15 to title XXX; and 

16 ‘‘(5) employ security and authentication stand17 ards, as the Secretary determines appropriate. 

18 ‘‘(d) RULE OF CONSTRUCTION REGARDING PRI19 VACY.—Nothing in this section shall be construed to alter 

20 existing obligations under the privacy, security, and 

21 breach notification rules promulgated under section 264(c) 

22 of the Health Insurance Portability and Accountability 

23 Act (or successor regulations), under part 2 of title 42, 

24 Code of Federal Regulations (or successor regulations), 

25 under section 444 of the General Education Provisions 


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1 Act (20 U.S.C. 1232g) (commonly referred to as the 

2 ‘Family Educational Rights and Privacy Act of 1974’), 

3 under the amendments made by the Genetic Information 

4 Nondiscrimination Act, or under State privacy law.’’. 

5 (b) EFFECTIVE DATE.—Section 2715B of the Public 

6 Health Service Act, as added by subsection (a), shall take 

7 effect 1 year after the date of enactment of this Act. 

8 SEC. 502. RECOGNITION OF SECURITY PRACTICES. 

9 Part 1 of subtitle D of the Health Information Tech10 nology for Economic and Clinical Health Act (42 U.S.C. 

11 17931 et seq.) is amended by adding at the end the fol12 lowing: 

13 ‘‘SEC. 13412. RECOGNITION OF SECURITY PRACTICES. 

14 ‘‘(a) IN GENERAL.—Consistent with the authority of 

15 the Secretary under sections 1176 and 1177 of the Social 

16 Security Act, when making determinations relating to 

17 fines under section 13410, decreasing the length and ex18 tent of an audit under section 13411, or remedies other19 wise agreed to by the Secretary, the Secretary shall con20 sider whether the entity or business associate had, for not 

21 less than the previous 12 months, recognized security 

22 practices in place that may— 

23 ‘‘(1) mitigate fines under section 13410; 

24 ‘‘(2) result in the early, favorable termination 

25 of an audit under section 13411; and 


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1 ‘‘(3) limit the remedies that would otherwise be 

2 agreed to in any agreement between the entity or 

3 business associate and the Department of Health 

4 and Human Services. 

5 ‘‘(b) ADDITIONAL CONSIDERATION.—At the election 

6 of the entity or business associate, the Secretary may pro7 vide further consideration to an entity or business asso8 ciate that can adequately demonstrate that such recog9 nized security practices were in place, as determined by 

10 the Secretary. 

11 ‘‘(c) DEFINITION AND MISCELLANEOUS PROVI12 SIONS.— 

13 ‘‘(1) RECOGNIZED SECURITY PRACTICES.—The 

14 term ‘recognized security practices’ means the stand15 ards, guidelines, best practices, methodologies, pro16 cedures, and processes developed under section 

17 2(c)(15) of the National Institute of Standards and 

18 Technology Act, the approaches promulgated under 

19 section 405(d) of the Cybersecurity Information 

20 Sharing Act of 2015, and any other program or 

21 processes that are equivalent to such requirements 

22 as may be developed through regulations. Such prac23 tices shall be determined by the entity or business 

24 associate, except where additional consideration is 

25 requested under subsection (b). 


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1 ‘‘(2) LIMITATION.—Nothing in this section 

2 shall be construed as providing the Secretary author3 ity to— 

4 ‘‘(A) increase fines under section 13410, or 

5 the length, extent or quantity of audits under 

6 section 13411, due to a lack of compliance with 

7 the recognized security practices; or 

8 ‘‘(B) mandate, direct, or condition the 

9 award of any Federal grant, contract, or pur10 chase, on compliance with such recognized secu11 rity practices. 

12 ‘‘(3) NO LIABILITY FOR NONPARTICIPATION.— 

13 Nothing in this section shall be construed to subject 

14 an entity or business associate to liability for elect15 ing not to engage in the recognized security prac16 tices defined by this section. 

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

18 this section shall be construed to limit the Sec19 retary’s authority to enforce the HIPAA Security 

20 rule (part 160 of title 45, Code of Federal Regula21 tions, and subparts A and C of part 164 of such 

22 title), or to supersede or conflict with an entity or 

23 business associate’s obligations under the HIPAA 

24 Security rule.’’. 


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1 SEC. 503. GAO STUDY ON THE PRIVACY AND SECURITY 

2 RISKS OF ELECTRONIC TRANSMISSION OF IN3 DIVIDUALLY IDENTIFIABLE HEALTH INFOR4 MATION TO AND FROM ENTITIES NOT COV5 ERED BY THE HEALTH INSURANCE PORT6 ABILITY AND ACCOUNTABILITY ACT. 

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

8 date of enactment of this Act, the Comptroller General 

9 of the United States shall conduct a study to— 

10 (1) describe the roles of Federal agencies and 

11 the private sector with respect to protecting the pri12 vacy and security of individually identifiable health 

13 information transmitted electronically to and from 

14 entities not covered by the regulations promulgated 

15 under section 264(c) of the Health Insurance Port16 ability and Accountability Act of 1996 (42 U.S.C. 

17 1320d–2 note); 

18 (2) identify recent developments regarding the 

19 use of application programming interfaces to access 

20 individually identifiable health information, and im21 plications for the privacy and security of such infor22 mation; 

23 (3) identify practices in the private sector, such 

24 as terms and conditions for use, relating to the pri25 vacy, disclosure, and secondary uses of individually 

26 identifiable health information transmitted electroniVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00194 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 cally to or from entities, selected by an individual, 

2 that are not subject to the regulations promulgated 

3 under section 264(c) of the Health Insurance Port4 ability and Accountability Act of 1996; and 

5 (4) identify steps the public and private sectors 

6 can take to improve the private and secure access to 

7 and availability of individually identifiable health in8 formation. 

9 (b) REPORT.—Not later than 1 year after the date 

10 of enactment of this Act, the Comptroller General of the 

11 United States shall submit to Congress a report con12 cerning the findings of the study conducted under sub13 section (a). 

14 SEC. 504. TECHNICAL CORRECTIONS. 

15 (a) IN GENERAL.—Section 3022(b) of the Public 

16 Health Service Act (42 U.S.C. 300jj–52(b)) is amended 

17 by adding at the end the following new paragraph: 

18 ‘‘(4) APPLICATION OF AUTHORITIES UNDER IN19 SPECTOR GENERAL ACT OF 1978.—In carrying out 

20 this subsection, the Inspector General shall have the 

21 same authorities as provided under section 6 of the 

22 Inspector General Act of 1978 (5 U.S.C. App.).’’. 

23 (b) EFFECTIVE DATE.—The amendment made by 

24 subsection (a) shall take effect as if included in the enactVerDate Sep 11 2014 03:15 Jun 26, 2019 Jkt 089200 PO 00000 Frm 00195 Fmt 6652 Sfmt 6201 E:\BILLS\S1895.IS S1895

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1 ment of the 21st Century Cures Act (Public Law 114– 

2 255). 

Æ 


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