II 

Calendar No. 133 

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 

JULY 8, 2019 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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. 


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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. 

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. 


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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. 

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 


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1 (2) in paragraph (2)(B)— 

2 (A) in clause (i)— 

3 (i) by inserting ‘‘or freestanding emer4 gency room’’ after ‘‘hospital’’; and 

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

6 after ‘‘emergency department’’; and 

7 (B) in clause (ii), by inserting ‘‘or emer8 gency room’’ after ‘‘hospital’’. 

9 SEC. 102. PROTECTION AGAINST SURPRISE BILLS. 

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

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

12 at the end the following: 

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

14 SERVICES.— 

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

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

17 group or individual health insurance coverage who 

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

19 services at an in-network facility, including any re20 ferrals for diagnostic services— 

21 ‘‘(A) the cost-sharing requirement (ex22 pressed as a copayment amount, coinsurance 

23 rate, or deductible) with respect to such services 

24 shall be the same requirement that would apply 

25 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 

25 in-network rate. The group health plan or health inVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

25 the penalties described under paragraph (1) with reVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 an application with respect to any drug subject to the proVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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; 

24 ‘‘(ii) ensure that any third-party sub25 contractors who perform the de-identificaVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 Secretary of Health and Human Services, and pubVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

25 prohibit a provider from requiring in the terms of a conVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00104 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 insurance issuer offering group or individual health insur25 ance coverage or an entity or subsidiary providing pharVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 manufacturers for claims inVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00114 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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, 

25 fees, alternative discounts, and all other remuVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00115 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00123 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00127 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00131 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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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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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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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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 

25 surgical benefits and mental health or subVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00143 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

25 with this section, the Secretary shall speciVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00147 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

25 under this section, the Secretary shall consult with approVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00153 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 to engage communities at high risk for outVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00157 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

25 with respect to Indian Tribes and Tribal organizaVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00158 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 

24 territorial public health departments for the expanVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00166 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00172 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00181 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 

26 section 3014(h) of title 18, United States Code, as amendVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00183 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS S1895

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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 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00187 Fmt 6652 Sfmt 6401 E:\BILLS\S1895.RS 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 

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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 

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1 ment of the 21st Century Cures Act (Public Law 114– 

2 255). 

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. 

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. 

Sec. 214. Actions for delays of generic drugs and biosimilar biological products. 

Sec. 215. Reducing the price of prescription 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. 


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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. 

Sec. 313. Group health plan reporting requirements. 

Sec. 314. Study by Comptroller General of United States. 

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. 

Sec. 411. Extension for community health centers, the national health service 

corps, and teaching health centers that operate GME programs. 

Sec. 412. Other programs. 

Sec. 413. Native American suicide prevention. 

Sec. 414. Minimum age of sale of tobacco products. 

Sec. 415. Sale of tobacco products to individuals under the age of 21. 

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. 

Sec. 505. Public meeting. 

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 (42 

6 U.S.C. 300gg–19a) is amended— 


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1 (1) in paragraph (1)— 

2 (A) in the matter preceding subparagraph 

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

4 room’’ after ‘‘hospital’’; and 

5 (B) in subparagraph (C)— 

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

7 freestanding emergency room’’ after ‘‘emer8 gency department’’; and 

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

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

11 as’’; and 

12 (2) in paragraph (2)(B)— 

13 (A) in clause (i)— 

14 (i) by inserting ‘‘or freestanding emer15 gency room’’ after ‘‘hospital’’; and 

16 (ii) by inserting ‘‘or freestanding emer17 gency room’’ after ‘‘emergency department’’; 

18 and 

19 (B) in clause (ii), by inserting ‘‘or free20 standing emergency room’’ after ‘‘hospital’’. 

21 SEC. 102. PROTECTION AGAINST SURPRISE BILLS. 

22 (a) PHSA.—Section 2719A of the Public Health Serv23 ice Act (42 U.S.C. 300gg–19a) is amended by adding at 

24 the end the following: 

25 ‘‘(e) OUT-OF-NETWORK ANCILLARY SERVICES.— 


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1 ‘‘(1) COVERAGE OF SERVICES.—Subject to sub2 section (h), in the case of an enrollee in a group 

3 health plan or group or individual health insurance 

4 coverage who receives out-of-network ancillary services 

5 at an in-network facility, including any referrals for 

6 diagnostic services, and such services would be covered 

7 under such plan or coverage if provided in-network— 

8 ‘‘(A) the cost-sharing requirement (expressed 

9 as a copayment amount, coinsurance rate, or de10 ductible) with respect to such services shall be the 

11 same requirement that would apply if such serv12 ices were provided by an in-network practi13 tioner, and any coinsurance or deductible shall 

14 be based on in-network rates; and 

15 ‘‘(B) amounts paid toward such cost-shar16 ing shall be counted towards the in-network de17 ductible and in-network out-of-pocket maximum 

18 amount, as applicable, under the plan or cov19 erage for the plan year. 

20 ‘‘(2) NOTICE BEFORE PROVIDING NON-EMER21 GENCY SERVICES.—Subject to subsection (h), in the 

22 case of an enrollee in a group health plan or group 

23 or individual health insurance coverage who receives 

24 out-of-network, non-emergency services that are not 

25 ancillary services, from an out-of-network provider at 


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1 an in-network facility, and such services would be 

2 covered under such plan or coverage if provided in3 network, the cost-sharing requirement (expressed as a 

4 copayment amount, coinsurance rate, or deductible) 

5 with respect to such services shall be the same require6 ment that would apply if such services were provided 

7 by an in-network practitioner, and any coinsurance 

8 or deductible shall be based on in-network rates, un9 less, as soon as practicable, and in no case later than 

10 48 hours prior to providing non-emergency services 

11 that are not ancillary services— 

12 ‘‘(A) the in-network facility provides to the 

13 enrollee who is scheduled to receive such services 

14 notice that— 

15 ‘‘(i) is provided in paper or electronic 

16 form (and including electronic notification 

17 whenever practicable); 

18 ‘‘(ii) states that such service will be 

19 provided out-of-network; 

20 ‘‘(iii) includes the estimated amount 

21 that such practitioner or facility may 

22 charge the enrollee for such services; and 

23 ‘‘(iv) provides the option to affirma24 tively consent to receiving such services 

25 from such practitioner or facility; 


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1 ‘‘(B) such enrollee signs such notice con2 senting to receive such services from an out-of3 network provider at an in-network facility, and 

4 acknowledging that the out-of-network services 

5 may be covered at an out-of-network cost-sharing 

6 amount, requiring higher cost-sharing obliga7 tions of the enrollee than if the service were pro8 vided by an in-network practitioner or facility; 

9 and 

10 ‘‘(C) such facility maintains documentation 

11 of the enrollee’s signature or confirmation of re12 ceipt of such information under subparagraph 

13 (B) in the enrollee’s patient record for 2 years 

14 after the date of services. 

15 ‘‘(3) DEFINITION.—For purposes of this sub16 section, the term ‘facility’ has the meaning given the 

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

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

19 ENROLLEES ADMITTED AFTER EMERGENCY SERVICES.— 

20 ‘‘(1) PROTECTION FOR ENROLLEES ADMITTED TO

21 THE HOSPITAL FOR EMERGENCY SERVICES PRIOR TO

22 STABILIZATION.—In the case of an enrollee in a 

23 group health plan or group or individual health in24 surance coverage who receives emergency services, or 

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1 gency department of an out-of-network facility and 

2 has not been stabilized (within the meaning of sub3 section (b)(2)(C)), if the patient is subsequently ad4 mitted to the out-of-network facility for care, the cost5 sharing requirement (expressed as a copayment 

6 amount, coinsurance rate, or deductible) with respect 

7 to any out-of-network services provided to the enrollee 

8 prior to being stable and in a condition to receive in9 formation under (2), is the same requirement that 

10 would apply as under subsection (b)(2)(C)(ii)(II). 

11 ‘‘(2) NOTICE AND CONSENT.— 

12 ‘‘(A) IN GENERAL.—Subject to subsection 

13 (h), in the case of an enrollee in a group health 

14 plan or group or individual health insurance 

15 coverage who receives emergency services, or ma16 ternal care for a woman in labor, in the emer17 gency department of an out-of-network facility 

18 and has been stabilized (within the meaning of 

19 subsection (b)(2)(C)), if the patient is subse20 quently admitted to the out-of-network facility 

21 for care, the cost-sharing requirement (expressed 

22 as a copayment amount, coinsurance rate, or de23 ductible) with respect to any out-of-network serv24 ices is the same requirement that would apply if 

25 such services were provided by an in-network 


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1 provider, unless the enrollee, once stable and in 

2 a condition to receive such information, includ3 ing having sufficient mental capacity— 

4 ‘‘(i) has been provided by the facility, 

5 prior to the provision of any post-stabiliza6 tion, out-of-network service at such facility, 

7 with— 

8 ‘‘(I) paper or electronic notifica9 tion that the practitioner or facility is 

10 an out-of-network health care provider 

11 and the out-of-network rate of the pro12 vider, as applicable, and the option to 

13 affirmatively consent to receiving serv14 ices from such practitioner or facility; 

15 and 

16 ‘‘(II) the estimated amount that 

17 such provider may charge the partici18 pant, beneficiary, or enrollee for such 

19 services involved; 

20 ‘‘(ii) has been provided by the plan or 

21 coverage, prior to the provision of any post22 stabilization, out-of-network service at such 

23 facility, with— 

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1 tion whenever practicable) that the 

2 practitioner or facility is an out-of-net3 work health care provider, and the op4 tion to affirmatively consent to receiv5 ing services from such practitioner or 

6 facility; 

7 ‘‘(II) a list of in-network practi8 tioners or facilities in the relevant geo9 graphic area that could provide the 

10 same services, and an option for a re11 ferral to such providers; and 

12 ‘‘(III) information about whether 

13 prior authorization or other care man14 agement limitations may be required 

15 in advance of receiving in-network 

16 services at the facility; 

17 ‘‘(iii) has acknowledged, in writing, 

18 that the out-of-network services provided 

19 after the individual has been stabilized may 

20 not be covered or may be covered at an out21 of-network cost-sharing amount, requiring 

22 higher cost-sharing obligations of the en23 rollee than if the service were provided at 

24 an in-network facility. 


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1 ‘‘(B) REQUIREMENTS OF NOTICE.—The no2 tice under subparagraph (A) shall be in a format 

3 determined by the Secretary to give a reasonable 

4 layperson clear comprehension of the terms of the 

5 agreement, including all possible financial re6 sponsibilities, including the requirements that 

7 the notice— 

8 ‘‘(i) does not exceed one page in length; 

9 ‘‘(ii) is readily identifiable for its pur10 pose and as a contract of consent; 

11 ‘‘(iii) clearly states that consent to po12 tential out-of-network charges is optional 

13 and that the enrollee has the choice to trans14 fer to an in-network facility; 

15 ‘‘(iv) includes an estimate of the 

16 amount that such provider will charge the 

17 participant, beneficiary, or enrollee for such 

18 services involved; and 

19 ‘‘(v) be available in the 15 most com20 mon languages in the facility’s geographic 

21 area, with the facility making a good faith 

22 effort to provide oral notice in the enrollee’s 

23 primary language if it is not one of such 15 

24 languages. 


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1 ‘‘(C) MAINTENANCE OF RECORDS.—A facil2 ity shall maintain documentation of notice given 

3 to an enrollee pursuant to this subsection and 

4 the enrollee’s confirmation of receipt of such in5 formation in the enrollee’s patient record for 2 

6 years after the date of services. 

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

8 after the date of enactment of the Lower Health Care 

9 Costs Act, the Secretary shall issue regulations to 

10 carry out this subsection, which shall include clari11 fication on how to determine whether an individual 

12 is stabilized and the timing of the notice required 

13 under this paragraph. 

14 ‘‘(g) PROHIBITION ON BILLING MORE THAN AN IN15 NETWORK RATE UNDER CERTAIN CIRCUMSTANCES.— 

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

17 furnishing— 

18 ‘‘(A) emergency services, as defined in sub19 section (b)(2), regardless of the State in which 

20 the patient resides; 

21 ‘‘(B) out-of-network services at an in-net22 work facility described in subsection (e)(1); 

23 ‘‘(C) out-of-network services at an in-net24 work facility described in subsection (e)(2), 

25 where the notice and consent for receiving such 


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1 services out-of-network did not meet the require2 ment of such subsection; 

3 ‘‘(D) services furnished by an out-of-network 

4 provider after an enrollee has been admitted to 

5 the hospital for emergency services but prior to 

6 stabilization, as described in subsection (f)(1); or 

7 ‘‘(E) out-of-network services furnished after 

8 the enrollee has been stabilized (within the mean9 ing of subsection (b)(2)(C)), where the notice and 

10 option for receiving care at an alternate facility 

11 required under subsection (f)(2) have not been 

12 provided to the enrollee and the enrollee did not 

13 give consent under subsection (f)(3), 

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

15 group or individual health insurance coverage for 

16 amounts beyond the cost-sharing amount that would 

17 apply under subsection (b)(1)(C)(ii)(II), (e)(1), (e)(2), 

18 or (f), as applicable. 

19 ‘‘(2) NOTICE.—A facility furnishing services de20 scribed in paragraph (1) shall provide enrollees in a 

21 group health plan or group or individual health in22 surance coverage with a one-page notice, in 16-point 

23 font, upon intake at the emergency room or being ad24 mitted at the facility of the prohibition on balance 

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


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1 recourse if they are sent a balance bill in violation of 

2 such paragraph. The facility shall be responsible for 

3 obtaining the signature from the enrollee on such no4 tice. The Secretary shall issue regulations within 6 

5 months of the date of enactment of the Lower Health 

6 Care Costs Act on the requirements for the notice 

7 under this paragraph. 

8 ‘‘(h) MAINTAINING STATE SURPRISE BILLING PRO9 TECTIONS.— 

10 ‘‘(1) IN GENERAL.—Nothing in this section shall 

11 prevent a State from establishing or continuing in ef12 fect, with respect to health insurance issuers, facili13 ties, or practitioners, an alternate method under State 

14 law for determining the appropriate compensation for 

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

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

17 group health plans or group or individual health in18 surance coverage offered in a State that has not estab19 lished an alternate method described in paragraph 

20 (1), such as arbitration or a benchmark, or for serv21 ices described in subsection (b), (e), or (f) that are not 

22 covered by such State’s alternate method described in 

23 paragraph (1), the provisions of this section shall 

24 apply. 


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

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

3 plan that is not subject to State insurance regulation. 

4 ‘‘(i) DEFINITIONS.—In this section: 

5 ‘‘(1) IN-NETWORK.—The term ‘in-network’, with 

6 respect to a group health plan or health insurance 

7 coverage means a provider that has a contractual re8 lationship with the plan. 

9 ‘‘(2) ENROLLEE.—The term ‘enrollee’, with re10 spect to health insurance coverage or a group health 

11 plan, includes a participant, dependent, or bene12 ficiary. 

13 ‘‘(3) ANCILLARY SERVICES.—The term ‘ancillary 

14 services’ means non-emergency care that is— 

15 ‘‘(A) provided by anesthesiologists, patholo16 gists, emergency medicine providers, intensivists, 

17 radiologists, neonatologists, hospitalists, and as18 sistant surgeons, whether the care is provided by 

19 a physician or non-physician practitioner; 

20 ‘‘(B) a diagnostic service (including radi21 ology and lab services); or 

22 ‘‘(C) provided by such other specialty prac23 titioner not typically selected by the patients re24 ceiving the care, which the Secretary may add 


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1 periodically to such definition through rule2 making.’’. 

3 (b) ENFORCEMENT OF BALANCE BILLING PROHIBI4 TIONS.—Part C of title XXVII of the Public Health Service 

5 Act (42 U.S.C. 300gg–91 et seq.) is amended by adding at 

6 the end the following: 

7 ‘‘SEC. 2795. ENFORCEMENT OF BALANCE BILLING PROHIBI8 TIONS. 

9 ‘‘(a) IN GENERAL.—Subject to subsection (b), a facil10 ity or practitioner that violates a requirement under section 

11 2719A(g)(1) or fails to provide notice or obtain consent as 

12 required under subsection (e)(2) or (f)(2) shall be subject 

13 to a civil monetary penalty of not more than $10,000 for 

14 each act constituting such violation. 

15 ‘‘(b) PROCEDURE.—The provisions of section 1128A of 

16 the Social Security Act, other than subsections (a) and (b) 

17 and the first sentence of subsection (c)(1) of such section, 

18 shall apply to civil money penalties under this subsection 

19 in the same manner as such provisions apply to a penalty 

20 or proceeding under section 1128A of the Social Security 

21 Act. 

22 ‘‘(c) SAFE HARBOR.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall waive 

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1 ingly violate, and should not have reasonably known 

2 it violated, section 2719A(g)(1) with respect to an en3 rollee, if such facility or practitioner, within 30 days 

4 of the violation, withdraws the bill that was in viola5 tion of section 2719A(g)(1), and, as applicable, reim6 burses the group health plan, health insurance issuer, 

7 or enrollee, in an amount equal to the difference be8 tween the amount billed and the amount allowed to 

9 be billed under section 2719A(g)(1), plus interest, at 

10 an interest rate determined by the Secretary. 

11 ‘‘(2) HARDSHIP EXEMPTION.—The Secretary 

12 may establish a hardship exemption to the penalties 

13 under this section. 

14 ‘‘(3) STATE ENFORCEMENT.—The Secretary shall 

15 waive penalties under this section with respect to a 

16 facility or practitioner that has already been subject 

17 to enforcement action under State law for a violation 

18 described in subsection (a).’’. 

19 (c) APPLICATION TO GRANDFATHERED PLANS.—Sec20 tion 1251(a) of the Patient Protection and Affordable Care 

21 Act (42 U.S.C. 18011(a)) is amended by adding at the end 

22 the following: 

23 ‘‘(5) APPLICATION OF ADDITIONAL PROVI24 SIONS.—Subsections (b) through (h) of section 2719A 

25 of the Public Health Service Act (42 U.S.C. 300gg– 


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1 19a) shall apply to grandfathered health plans for 

2 plan years beginning with the second plan year that 

3 begins after the date of enactment of the Lower Health 

4 Care Costs Act.’’. 

5 (d) COVERAGE UNDER FEDERAL EMPLOYEES HEALTH

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

7 States Code, is amended by adding at the end the following: 

8 ‘‘(c) Any health benefits plan offered under this chapter 

9 shall be treated as a group health plan or group or indi10 vidual health insurance coverage for purposes of subsections 

11 (e) through (g) of section 2719A of the Public Health Service 

12 Act (42 U.S.C. 300gg–19a) (except for paragraph (3) of 

13 such subsection (g)).’’. 

14 SEC. 103. BENCHMARK FOR PAYMENT. 

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

16 of the Public Health Service Act (42 U.S.C. 300gg–11 et 

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

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

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

20 health plan or health insurance issuer offering group or in21 dividual health insurance coverage shall pay providers, in22 cluding facilities and practitioners, furnishing services for 

23 which such facilities and practitioners are prohibited under 

24 section 2719A(g) from billing enrollees for amounts beyond 

25 the cost-sharing amount that would apply under subsection 


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1 (b)(1)(C)(ii)(II), (e), or (f) of section 2719A,the median in2 network rate for such services provided to enrollees, using 

3 a methodology determined under subsection (b) for the same 

4 or similar services offered by the group health plan or health 

5 insurance issuer in that geographic region. Such payment 

6 shall be made in a timely fashion in order to ensure compli7 ance with sections 399V–7 and 2729D. 

8 ‘‘(b) MEDIAN IN-NETWORK RATE.— 

9 ‘‘(1) IN GENERAL.—For purposes of this section, 

10 the term ‘median in-network rate’ means, with respect 

11 to health care services covered by a group health plan 

12 or group or individual health insurance coverage, the 

13 median contracted rate under the applicable plan or 

14 coverage recognized under the plan or coverage as the 

15 total maximum payment for the service minus the in16 network cost-sharing for such service under the plan 

17 or coverage, for the same or a similar service that is 

18 provided by a provider in the same or similar spe19 cialty and in the geographic region in which the serv20 ice is furnished. 

21 ‘‘(2) RULEMAKING.— 

22 ‘‘(A) IN GENERAL.—Not later than 1 year 

23 after the date of enactment of the Lower Health 

24 Care Costs Act, the Secretary shall, through rule25 making, determine the methodology a group 


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1 health plan or health insurance issuer is re2 quired to use to determine the median in-net3 work rate described in paragraph (1), differen4 tiating by business line, the information the plan 

5 or issuer shall share with the out-of-network pro6 vider involved when making such a determina7 tion, and the geographic regions applied for pur8 poses of this subsection. Such rulemaking shall 

9 take into account payments that are made by 

10 health insurance issuers that are not on a fee-for11 service basis. 

12 ‘‘(B) GEOGRAPHIC REGIONS.—In estab13 lishing geographic regions under subparagraph 

14 (A), the Secretary shall consider adequate access 

15 to services in rural areas and health professional 

16 shortage areas, as defined in section 332. The 

17 Secretary shall consult with the National Asso18 ciation of Insurance Commissioners in estab19 lishing the geographic regions. The Secretary 

20 shall update the geographic regions periodically, 

21 as appropriate, taking into account the findings 

22 of the report under section 106 of the Lower 

23 Health Care Costs Act. 

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

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1 dividual health insurance coverage does not have suf2 ficient information to calculate a median in-network 

3 rate for this service or provider type, or amount of, 

4 claims for services (as determined by the applicable 

5 State authority, in the case of health insurance cov6 erage, or by the Secretary of Labor, in the case of a 

7 self-insured group health plan) covered under the list 

8 of out-of-network services set by the State authority or 

9 Secretary of Labor, as applicable, in a particular geo10 graphic area, such plan or issuer shall demonstrate 

11 that it will use a database free of conflicts of interest 

12 that has sufficient information reflecting allowed 

13 amounts paid to individual health care providers for 

14 relevant services provided in the applicable geo15 graphic region, and that such plan or issuer will use 

16 that database to determine a median in-network rate. 

17 The group health plan or health insurance issuer shall 

18 cover the cost of accessing the database. 

19 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

20 subsection shall prevent a group health plan or health 

21 insurance issuer from establishing separate calcula22 tions of a median in-network rate under paragraph 

23 (1) for services delivered in nonhospital facilities, in24 cluding freestanding emergency rooms. 


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

2 ‘health care facility’ or ‘facility’ includes hospitals, hospital 

3 outpatient departments, critical access hospitals, ambula4 tory surgery centers, laboratories, radiology clinics, free5 standing emergency rooms, and any other facility that pro6 vides services that are covered under a group health plan 

7 or health insurance coverage, including settings of care sub8 ject to section 2719A(b).’’. 

9 (b) NON-FEDERAL GOVERNMENTAL PLANS.—Section 

10 2722(a)(2)(E) of the Public Health Service Act (42 U.S.C. 

11 300gg–21(a)(2)(E)) is amended by inserting ‘‘, except that 

12 such election shall be available with respect to section 

13 2729A’’ before the period. 

14 SEC. 104. EFFECTIVE DATE. 

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

16 shall take effect beginning in the second plan year that be17 gins after the date of enactment of this Act. 

18 SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS. 

19 (a) IN GENERAL.—Part A of title XXVII of the Public 

20 Health Service Act is amended by inserting after section 

21 2719A (42 U.S.C. 300gg–19a) the following: 

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

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

24 group health plan or group or individual health insurance 

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1 of-network provider, if such services would be covered if pro2 vided by an in-network provider— 

3 ‘‘(1) the cost-sharing requirement (expressed as a 

4 copayment amount, coinsurance rate, or deductible) 

5 with respect to such services shall be the same require6 ment that would apply if such services were provided 

7 by an in-network practitioner, and any coinsurance 

8 or deductible shall be based on in-network rates; and 

9 ‘‘(2) such cost-sharing amounts shall be counted 

10 towards the in-network deductible and in-network 

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

12 coverage for the plan year. 

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

14 insurance issuer shall pay for air ambulance services for 

15 purposes of subsection (a) at the median in-network as de16 fined in subsection (c). 

17 ‘‘(c) MEDIAN IN-NETWORK RATE.— 

18 ‘‘(1) IN GENERAL.—For purposes of this section, 

19 the term ‘median in-network rate’ means, with respect 

20 to air ambulance services covered by a group health 

21 plan or group or individual health insurance cov22 erage, the median contracted rate under the applica23 ble plan or coverage recognized under the plan or cov24 erage as the total maximum payment for the service, 

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


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1 under the plan or coverage, for the same or a similar 

2 service that is provided by a provider in the same or 

3 similar specialty, and in the geographic region in 

4 which the service is furnished. 

5 ‘‘(2) RULEMAKING.— 

6 ‘‘(A) IN GENERAL.—Not later than 6 

7 months after the date of enactment of the Lower 

8 Health Care Costs Act, the Secretary shall, 

9 through rulemaking, determine the methodology 

10 a group health plan or health insurance issuer is 

11 required to use to determine the median in-net12 work rate described in paragraph (1), the infor13 mation the plan or issuer shall share with the 

14 out-of-network provider involved when making 

15 such a determination, and the geographic regions 

16 applied for purposes of this subsection. Such 

17 rulemaking shall take into account payments 

18 that are made by issuers that are not on a fee19 for-service basis. 

20 ‘‘(B) GEOGRAPHIC REGIONS.—In estab21 lishing geographic regions as described in sub22 paragraph (A), the Secretary shall consider ade23 quate access to services in rural areas. The Sec24 retary shall consult with the National Associa25 tion of Insurance Commissioners in establishing 


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1 the geographic regions. The Secretary shall up2 date the geographic regions periodically, as ap3 propriate, taking into account the findings of the 

4 report under section 106 of the Lower Health 

5 Care Costs Act. 

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

7 plan or health insurance issuer offering group or in8 dividual health insurance coverage does not have suf9 ficient information to calculate a median in-network 

10 rate for this service or provider type, or amount of, 

11 claims for services (as determined by the applicable 

12 State authority, in the case of health insurance cov13 erage, or by the Secretary of Labor, in the case of a 

14 self-insured group health plan) covered under the list 

15 of out-of-network services set by the State authority or 

16 Secretary of Labor, as applicable, in a particular geo17 graphic area, such plan or issuer shall demonstrate 

18 that it will use a database free of conflicts of interest 

19 that has sufficient information reflecting allowed 

20 amounts paid to individual health care providers for 

21 relevant services provided in the applicable geo22 graphic region, and that such plan or issuer will use 

23 that database to determine a median in-network rate. 

24 The group health plan or health insurance issuer shall 

25 cover the cost of accessing the database. 


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1 ‘‘(4) CLARIFICATION.—For purposes of this sub2 section, the Secretary may define geographic regions 

3 that are different from the geographic regions identi4 fied for purposes of section 2729A(b) to ensure that 

5 an adequate number of air ambulance services are in6 network in each geographic region so that a median 

7 in-network rate for air ambulance services may be 

8 calculated for each such region. 

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

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

11 plan or group or individual health insurance coverage for 

12 amounts beyond the cost-sharing amount that applies under 

13 subsection (a). 

14 ‘‘(e) ENFORCEMENT.— 

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

16 air ambulance service provider that violates sub17 section (d) shall be subject to a civil monetary penalty 

18 of not more than $10,000 for each act constituting 

19 such violation. 

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

21 1128A of the Social Security Act, other than sub22 sections (a) and (b) and the first sentence of sub23 section (c)(1) of such section, shall apply to civil 

24 money penalties under this subsection in the same 

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1 ceeding under section 1128A of the Social Security 

2 Act. 

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

4 the penalties described under paragraph (1) with re5 spect to a air ambulance service provider who un6 knowingly violates subsection (d) with respect to an 

7 enrollee, if such air ambulance service provider with8 in 30 days of the violation, withdraws the bill that 

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

10 reimburses the group health plan, health insurance 

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

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

13 plus interest, at an interest rate determined by the 

14 Secretary.’’. 

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

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

17 effect on the date that is 1 year after the date of enactment 

18 of this Act. 

19 SEC. 106. REPORT. 

20 Not later than 1 year after the effective date described 

21 in section 104, and annually for the following 4 years, the 

22 Secretary of Health and Human Services, in consultation 

23 with the Federal Trade Commission and the Attorney Gen24 eral, shall— 

25 (1) conduct a study on— 


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1 (A) the effects of the amendments made by 

2 sections 101, 102, 103, and 105, including any 

3 patterns of vertical or horizontal integration of 

4 health care facilities, providers, group health 

5 plans, or health insurance issuers; 

6 (B) the effects of the amendments made by 

7 sections 101, 102, 103, and 105 on overall health 

8 care costs; 

9 (C) the effects of the amendments made by 

10 sections 101, 102, 103, and 105 on access to serv11 ices, including specialty services, in rural areas 

12 and health professional shortage areas as defined 

13 in section 332; and 

14 (D) recommendations, made in consultation 

15 with the Secretary of Labor and the Secretary of 

16 the Treasury, for effective enforcement of 2729A 

17 of the Public Health Service Act, as added by 

18 section 103, including potential challenges to ad19 dressing anti-competitive consolidation by health 

20 care facilities, providers, group health plans, or 

21 health insurance issuers; and 

22 (2) submit a report on such study to the Com23 mittee on Health, Education, Labor, and Pensions, 

24 the Committee on Commerce, Science, and Transpor25 tation, the Committee on Finance, and the Committee 


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1 on the Judiciary of the Senate and the Committee on 

2 Education and Labor, the Committee on Energy and 

3 Commerce, the Committee on Ways and Means, and 

4 the Committee on the Judiciary of the House of Rep5 resentatives. 

6 TITLE II—REDUCING THE 

7 PRICES OF PRESCRIPTION 

8 DRUGS 

9 SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 

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

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

12 end the following: 

13 ‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT TO

14 PATENTS.— 

15 ‘‘(1) APPROVED APPLICATION HOLDER LISTING

16 REQUIREMENTS.— 

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

18 of enactment of the Lower Health Care Costs Act, 

19 within 60 days of approval of an application 

20 under subsection (a) or (k), the holder of such 

21 approved application shall submit to the Sec22 retary a list of each patent required to be dis23 closed (as described in paragraph (3)). 

24 ‘‘(B) PREVIOUSLY APPROVED OR LICENSED

25 BIOLOGICAL PRODUCTS.— 


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1 ‘‘(i) PRODUCTS LICENSED UNDER SEC2 TION 351 OF THE PHSA.—Not later than 30 

3 days after the date of enactment of the 

4 Lower Health Care Costs Act, the holder of 

5 a biological product license that was ap6 proved under subsection (a) or (k) before the 

7 date of enactment of such Act shall submit 

8 to the Secretary a list of each patent re9 quired to be disclosed (as described in para10 graph (3)). 

11 ‘‘(ii) PRODUCTS APPROVED UNDER

12 SECTION 505 OF THE FFDCA.—Not later 

13 than 30 days after March 23, 2020, the 

14 holder of an approved application for a bio15 logical product under section 505 of the 

16 Federal Food, Drug, and Cosmetic Act that 

17 is deemed to be a license for the biological 

18 product under this section on March 23, 

19 2020, shall submit to the Secretary a list of 

20 each patent required to be disclosed (as de21 scribed in paragraph (3)). 

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

23 product license that is the subject of an applica24 tion under subsection (a) or (k) shall submit to 

25 the Secretary a list that includes— 


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1 ‘‘(i) any patent not previously required 

2 to be disclosed (as described in paragraph 

3 (3)) under subparagraph (A) or (B), as ap4 plicable, within 30 days of the earlier of— 

5 ‘‘(I) the date of issuance of such 

6 patent by the United States Patent 

7 and Trademark Office; or 

8 ‘‘(II) the date of approval of a 

9 supplemental application for the bio10 logical product; and 

11 ‘‘(ii) any patent, or any claim with re12 spect to a patent, included on the list pur13 suant to this paragraph, that the Patent 

14 Trial and Appeal Board of the United 

15 States Patent and Trademark Office deter16 mines in a written decision to cancel as 

17 unpatentable, within 30 days of such deci18 sion. 

19 ‘‘(2) PUBLICATION OF INFORMATION.— 

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

21 date of enactment of the Lower Health Care 

22 Costs Act, the Secretary shall publish and make 

23 available to the public a single, easily searchable 

24 list that includes— 


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1 ‘‘(i) the official and proprietary name 

2 of each biological product licensed, or 

3 deemed to be licensed, under subsection (a) 

4 or (k); 

5 ‘‘(ii) with respect to each biological 

6 product described in clause (i), each patent 

7 submitted in accordance with paragraph 

8 (1); 

9 ‘‘(iii) the date of licensure and appli10 cation number for each such biological prod11 uct; 

12 ‘‘(iv) the marketing status, dosage 

13 form, route of administration, strength, 

14 and, if applicable, reference product, for 

15 each such biological product; 

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

17 biological product, including whether the li18 cense at the time of listing is approved, 

19 withdrawn, or revoked; 

20 ‘‘(vi) with respect to each such biologi21 cal product, any period of exclusivity under 

22 paragraph (6), (7)(A), or (7)(B) of sub23 section (k) of this section or section 527 of 

24 the Federal Food, Drug, and Cosmetic Act, 

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1 ance with subsection (m) of this section, for 

2 which the Secretary has determined such bi3 ological product to be eligible, and the date 

4 on which such exclusivity expires; 

5 ‘‘(vii) any determination of biosimi6 larity or interchangeability for each such 

7 biological product; and 

8 ‘‘(viii) information regarding approved 

9 indications for each such biological product, 

10 in such manner as the Secretary determines 

11 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 infor21 mation 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 Lower 

3 Health Care Costs Act, the Secretary, in con4 sultation with the Director of the United States 

5 Patent and Trademark Office, shall publish and 

6 make available to the public a list of any holders 

7 of biological product licenses, and the cor8 responding biological product or products, that 

9 failed to submit information as required under 

10 paragraph (1), including any updates required 

11 under paragraph (1)(C), in such manner and 

12 format as the Secretary determines appropriate. 

13 If information required under paragraph (1) is 

14 submitted following publication of such list, the 

15 Secretary shall remove such holders of such bio16 logical product licenses from the public list in a 

17 reasonable period of time. 

18 ‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.—In 

19 this section, a ‘patent required to be disclosed’ is any 

20 patent for which the holder of a biological product li21 cense approved under subsection (a) or (k), or a bio22 logical product application approved under section 

23 505 of the Federal Food, Drug, and Cosmetic Act and 

24 deemed to be a license for a biological product under 

25 this section on March 23, 2020, believes a claim of 


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1 patent infringement could reasonably be asserted by 

2 the holder, or by a patent owner that has granted an 

3 exclusive license to the holder with respect to the bio4 logical product that is the subject of such license, if 

5 a person not licensed by the owner engaged in the 

6 making, using, offering to sell, selling, or importing 

7 into the United States of the biological product that 

8 is the subject of such license.’’. 

9 (b) DISCLOSURE OF PATENTS.—Section 

10 351(l)(3)(A)(i) of the Public Health Service Act (42 U.S.C. 

11 262(l)(3)(A)(i)) is amended by inserting ‘‘included in the 

12 list provided by the reference product sponsor under sub13 section (o)(1)’’ after ‘‘a list of patents’’. 

14 (c) REVIEW AND REPORT ON NONCOMPLIANCE.—Not 

15 later than 30 months after the date of enactment of this 

16 Act, the Secretary shall— 

17 (1) solicit public comments regarding appro18 priate remedies, in addition to the publication of the 

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

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

21 by subsection (a), with respect to holders of biological 

22 product licenses who fail to timely submit informa23 tion as required under subsection (o)(1) of such sec24 tion 351, including any updates required under sub25 paragraph (C) of such subsection (o)(1); and 


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1 (2) submit to Congress an evaluation of com2 ments received under paragraph (1) and the rec3 ommendations of the Secretary concerning appro4 priate remedies. 

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

6 Human Services may promulgate regulations to carry out 

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

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

9 (e) RULE OF CONSTRUCTION.—Nothing in this Act, in10 cluding an amendment made by this Act, shall be construed 

11 to require or allow the Secretary of Health and Human 

12 Services to delay the licensing of a biological product under 

13 section 351 of the Public Health Service Act (42 U.S.C. 

14 262). 

15 SEC. 202. ORANGE BOOK MODERNIZATION. 

16 (a) SUBMISSION OF PATENT INFORMATION FOR BRAND

17 NAME DRUGS.— 

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

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

20 (21 U.S.C. 355(b)) is amended to read as follows: 

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

22 application with respect to any drug subject to the provi23 sions of subsection (a). Such persons shall submit to the 

24 Secretary as part of the application— 


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

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

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

4 ‘‘(ii) a full list of the articles used as components 

5 of such drug; 

6 ‘‘(iii) a full statement of the composition of such 

7 drug; 

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

9 and the facilities and controls used for, the manufac10 ture, processing, and packing of such drug; 

11 ‘‘(v) such samples of such drug and of the arti12 cles used as components thereof as the Secretary may 

13 require; 

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

15 used for such drug; 

16 ‘‘(vii) any assessments required under section 

17 505B; and 

18 ‘‘(viii) the patent number and expiration date, of 

19 each patent for which a claim of patent infringement 

20 could reasonably be asserted if a person not licensed 

21 by the owner engaged in the manufacture, use, or sale 

22 of the drug, and that— 

23 ‘‘(I) claims the drug for which the applicant 

24 submitted the application and is a drug sub25 stance patent or a drug product patent; or 


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

2 for which approval is sought or has been granted 

3 in the application. 

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

5 for a drug, and a patent of the type described in subpara6 graph (A)(viii) that claims such drug or a method of using 

7 such drug is issued after the filing date, the applicant shall 

8 amend the application to include such patent informa9 tion.’’. 

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

11 Human Services shall, in consultation with the Direc12 tor of the National Institutes of Health and with rep13 resentatives of the drug manufacturing industry, re14 view and develop guidance, as appropriate, on the in15 clusion of women and minorities in clinical trials re16 quired under subsection (b)(1)(A)(i) of section 505 of 

17 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 355), as amended by paragraph (1). 

19 (b) CONFORMING CHANGES TO REQUIREMENTS FOR

20 SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 

21 Section 505(c)(2) of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 355(c)(2)) is amended— 

23 (1) by inserting before the first sentence the fol24 lowing: ‘‘Not later than 30 days after the date of ap25 proval of an application under subsection (b), the 


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1 holder of the approved application shall file with the 

2 Secretary the patent number and the expiration date 

3 of any patent described in subclause (I) or (II) of sub4 section (b)(1)(A)(viii), except that a patent that is 

5 identified as claiming a method of using such drug 

6 shall be filed only if the patent claims a method of 

7 use approved in the application. The holder of the ap8 proved application shall file with the Secretary the 

9 patent number and the expiration date of any patent 

10 described in subclause (I) or (II) of subsection 

11 (b)(1)(A)(viii) that is issued after the date of ap12 proval of the application, not later than 30 days after 

13 the date of issuance of the patent, except that a patent 

14 that claims a method of using such drug shall be filed 

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

16 application.’’; 

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

18 the expiration date of any patent which’’ the fol19 lowing: ‘‘fulfills the criteria in subsection (b) and’’; 

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

21 amended by paragraph (1)) the following: ‘‘Patent in22 formation that is not the type of patent information 

23 required by subsection (b)(1)(A)(viii) shall not be sub24 mitted under this paragraph.’’; and 


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1 (4) by inserting after ‘‘could not file patent in2 formation under subsection (b) because no patent’’ the 

3 following: ‘‘of the type required to be submitted in 

4 subsection (b)(1)(A)(viii)’’. 

5 (c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) of 

6 section 505(j)(7) of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 355(j)(7)) is amended by adding at the end 

8 the following: 

9 ‘‘(iv) For each drug included on the list, the Secretary 

10 shall specify any exclusivity period that is applicable, for 

11 which the Secretary has determined the expiration date, 

12 and for which such period has not yet expired under— 

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

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

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

16 this subsection; 

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

18 (5)(F) of this subsection; 

19 ‘‘(IV) section 505A; 

20 ‘‘(V) section 505E; 

21 ‘‘(VI) section 527(a); or 

22 ‘‘(VII) subsection (u)’’. 

23 (d) ORANGE BOOK UPDATES WITH RESPECT TO IN24 VALIDATED PATENTS.— 

25 (1) IN GENERAL.— 


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

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 355(j)(7)(A)), as amended by subsection 

4 (c), is further amended by adding at the end the 

5 following: 

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

7 list under clause (i) includes a patent for such drug, 

8 and where the Under Secretary of Commerce for In9 tellectual Property and Director of the United States 

10 Patent and Trademark Office have cancelled any 

11 claim of the patent pursuant to a decision by the Pat12 ent Trial and Appeal Board in an inter partes review 

13 conducted under chapter 31 of title 35, United States 

14 Code, or a post-grant review conducted under chapter 

15 32 of that title, and from which no appeal has been 

16 taken, or can be taken, the holder of the applicable 

17 approved application shall notify the Secretary, in 

18 writing, within 14 days of such cancellation, and, if 

19 the patent has been deemed wholly inoperative or in20 valid, or if a patent claim has been cancelled, the re21 visions required under clause (iii) shall include strik22 ing the patent or information regarding such patent 

23 claim from the list with respect to such drug, as ap24 plicable, except that the Secretary shall not remove a 

25 patent from the list before the expiration of any 180- 


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1 day exclusivity period under paragraph (5)(B)(iv) 

2 that relies on a certification described in paragraph 

3 (2)(A)(vii)(IV) with respect to such patent.’’. 

4 (B) APPLICATION.—The amendment made 

5 by subparagraph (A) shall not apply with re6 spect to any determination with respect to a pat7 ent or patent claim that is made prior to the 

8 date of enactment of this Act. 

9 (2) NO EFFECT ON FIRST APPLICANT EXCLU10 SIVITY PERIOD.—Section 505(j)(5)(B)(iv)(I), as 

11 amended by section 205, is amended by adding at the 

12 end the following: ‘‘This subclause shall apply even if 

13 a patent is stricken from the list under paragraph 

14 (7)(A), pursuant to paragraph (7)(A)(v), provided 

15 that, at the time that the first applicant submitted an 

16 application under this subsection containing a certifi17 cation described in paragraph (2)(A)(vii)(IV), the 

18 patent that was the subject of such certification was 

19 included in such list with respect to the listed drug.’’. 

20 SEC. 203. ENSURING TIMELY ACCESS TO GENERICS. 

21 Section 505(q) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355(q)) is amended— 

23 (1) in paragraph (1)— 

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

25 10.31,’’ after ‘‘10.30’’; 


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1 (B) in subparagraph (E)— 

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

3 inserting ‘‘application or’’; 

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

5 inserting the following: 

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

7 and 

8 (iii) by striking the second sentence 

9 and inserting the following: 

10 ‘‘(ii) PRIMARY PURPOSE OF DELAY11 ING.— 

12 ‘‘(I) IN GENERAL.—In deter13 mining whether a petition was sub14 mitted with the primary purpose of de15 laying an application, the Secretary 

16 may consider the following factors: 

17 ‘‘(aa) Whether the petition 

18 was submitted in accordance with 

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

20 the petitioner knew or reasonably 

21 should have known the relevant 

22 information relied upon to form 

23 the basis of such petition. 

24 ‘‘(bb) Whether the petitioner 

25 has submitted multiple or serial 


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1 petitions or supplements to peti2 tions raising issues that reason3 ably could have been known to the 

4 petitioner at the time of submis5 sion of the earlier petition or peti6 tions. 

7 ‘‘(cc) Whether the petition 

8 was submitted close in time to a 

9 known, first date upon which an 

10 application under subsection 

11 (b)(2) or (j) of this section or sec12 tion 351(k) of the Public Health 

13 Service Act could be approved. 

14 ‘‘(dd) Whether the petition 

15 was submitted without relevant 

16 data or information in support of 

17 the scientific positions forming the 

18 basis of such petition. 

19 ‘‘(ee) Whether the petition 

20 raises the same or substantially 

21 similar issues as a prior petition 

22 to which the Secretary has re23 sponded substantively already, in24 cluding if the subsequent submisVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00238 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 sion follows such response from 

2 the Secretary closely in time. 

3 ‘‘(ff) Whether the petition re4 quests changing the applicable 

5 standards that other applicants 

6 are required to meet, including re7 questing testing, data, or labeling 

8 standards that are more onerous 

9 or rigorous than the standards the 

10 Secretary has determined to be 

11 applicable to the listed drug, ref12 erence product, or petitioner’s 

13 version of the same drug. 

14 ‘‘(gg) The petitioner’s record 

15 of submitting petitions to the 

16 Food and Drug Administration 

17 that have been determined by the 

18 Secretary to have been submitted 

19 with the primary purpose of 

20 delay. 

21 ‘‘(hh) Other relevant and ap22 propriate factors, which the Sec23 retary shall describe in guidance. 

24 ‘‘(II) GUIDANCE.—The Secretary 

25 may issue or update guidance, as apVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00239 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 propriate, to describe factors the Sec2 retary considers in accordance with 

3 subclause (II).’’; 

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

5 ‘‘(iii) REFERRAL TO THE FEDERAL

6 TRADE COMMISSION.—The Secretary shall 

7 establish procedures for referring to the Fed8 eral Trade Commission any petition or sup9 plement to a petition that the Secretary de10 termines was submitted with the primary 

11 purpose of delaying approval of an applica12 tion. Such procedures shall include notifica13 tion to the petitioner by the Secretary.’’; 

14 (D) by striking subparagraph (F); 

15 (E) by redesignating subparagraphs (G) 

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

17 respectively; and 

18 (F) in subparagraph (H), as so redesig19 nated, by striking ‘‘submission of this petition’’ 

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

21 (2) in paragraph (2)— 

22 (A) by redesignating subparagraphs (A) 

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

24 respectively; 


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

2 as so redesignated, the following: 

3 ‘‘(A) IN GENERAL.—A person shall submit a 

4 petition to the Secretary under paragraph (1) 

5 before filing a civil action in which the person 

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

7 prevent submission, review, or approval of an 

8 application submitted under subsection (b)(2) or 

9 (j) of this section or section 351(k) of the Public 

10 Health Service Act. Such petition and any sup11 plement to such a petition shall describe all in12 formation and arguments that form the basis of 

13 the relief requested in any civil action described 

14 in the previous sentence. 

15 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PETI16 TION.—A petition and any supplement to a peti17 tion shall be submitted within 60 days after the 

18 person knew, or reasonably should have known, 

19 the information that forms the basis of the re20 quest made in the petition or supplement.’’; 

21 (C) in subparagraph (C), as so redesig22 nated— 

23 (i) in the heading, by striking ‘‘WITHIN

24 150 DAYS’’; 


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

2 the 150-day period referred to in paragraph 

3 (1)(F),’’; and 

4 (iii) by amending clause (ii) to read as 

5 follows: 

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

7 days after the date of submission of the peti8 tion, the Secretary approves or has ap9 proved the application that is the subject of 

10 the petition without having made such a 

11 final decision.’’; 

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

13 redesignated, to read as follows: 

14 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC15 TIONS.— 

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

17 civil action against the Secretary in which 

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

19 withdraw, or prevent submission, review, or 

20 approval of an application submitted under 

21 subsection (b)(2) or (j) of this section or sec22 tion 351(k) of the Public Health Service Act 

23 without complying with the requirements of 

24 subparagraph (A), the court shall dismiss 


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1 without prejudice the action for failure to 

2 exhaust administrative remedies. 

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

4 civil action against the Secretary in which 

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

6 withdraw, or prevent submission, review, or 

7 approval of an application submitted under 

8 subsection (b)(2) or (j) of this section or sec9 tion 351(k) of the Public Health Service Act 

10 without complying with the requirements of 

11 subparagraph (B), the court shall dismiss 

12 with prejudice the action for failure to time13 ly file a petition. 

14 ‘‘(iii) FINAL RESPONSE.—If a civil ac15 tion is filed against the Secretary with re16 spect to any issue raised in a petition time17 ly filed under paragraph (1) in which the 

18 petitioner requests that the Secretary take 

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

20 aside, delay, rescind, withdraw, or prevent 

21 submission, review, or approval of an appli22 cation submitted under subsection (b)(2) or 

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

24 Public Health Service Act before the Sec25 retary has taken final agency action on the 


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1 petition within the meaning of subpara2 graph (C), the court shall dismiss without 

3 prejudice the action for failure to exhaust 

4 administrative remedies.’’; and 

5 (E) in clause (iii) of subparagraph (E), as 

6 so redesignated, by striking ‘‘as defined under 

7 subparagraph (2)(A)’’ and inserting ‘‘within the 

8 meaning of subparagraph (C)’’; and 

9 (3) in paragraph (4)— 

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

11 follows through ‘‘This subsection does’’ and in12 serting ‘‘EXCEPTIONS.—This subsection does’’; 

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

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

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

16 adjusting the margins accordingly. 

17 SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS. 

18 Section 351(k)(7) of the Public Health Service Act (42 

19 U.S.C. 262(k)(7)) is amended by adding at the end the fol20 lowing: 

21 ‘‘(D) DEEMED LICENSES.— 

22 ‘‘(i) NO ADDITIONAL EXCLUSIVITY

23 THROUGH DEEMING.—An approved appli24 cation that is deemed to be a license for a 

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1 ant to section 7002(e)(4) of the Biologics 

2 Price Competition and Innovation Act of 

3 2009 shall not be treated as having been 

4 first licensed under subsection (a) for pur5 poses of subparagraphs (A) and (B). 

6 ‘‘(ii) APPLICATION OF LIMITATIONS ON

7 EXCLUSIVITY.—Subparagraph (C) shall 

8 apply with respect to a reference product re9 ferred to in such subparagraph that was the 

10 subject of an approved application that was 

11 deemed to be a license pursuant to section 

12 7002(e)(4) of the Biologics Price Competi13 tion and Innovation Act of 2009. 

14 ‘‘(iii) APPLICABILITY.—The exclusivity 

15 periods described in section 527, section 

16 505A(b)(1)(A)(ii), and section 

17 505A(c)(1)(A)(ii) of the Federal Food, 

18 Drug, and Cosmetic Act shall continue to 

19 apply to a biological product after an ap20 proved application for the biological prod21 uct is deemed to be a license for the biologi22 cal product under subsection (a) pursuant 

23 to section 7002(e)(4) of the Biologics Price 

24 Competition and Innovation Act of 2009.’’. 


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1 SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS. 

2 (a) IN GENERAL.—Section 505(j)(5)(B)(iv)(I) of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 355(j)(5)(B)(iv)(I)) is amended— 

5 (1) by striking ‘‘180 days after the date’’ and in6 serting ‘‘180 days after the earlier of the following: 

7 ‘‘(aa) The date’’; and 

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

9 ‘‘(bb) The date on which all of the fol10 lowing conditions are first met, provided no 

11 application submitted by any first appli12 cant is approved on or before such date: 

13 ‘‘(AA) An application for the drug 

14 submitted by an applicant other than 

15 a first applicant has received tentative 

16 approval and could receive approval, if 

17 no first applicant were eligible for 180- 

18 day exclusivity under this clause, and 

19 such applicant has not entered into an 

20 agreement that would prevent commer21 cial marketing upon approval and has 

22 submitted a notification to the Sec23 retary documenting that it has not en24 tered into an agreement that would 

25 prevent commercial marketing. 


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1 ‘‘(BB) Thirty-three months have 

2 passed since the date of submission of 

3 an application for the drug by one 

4 first applicant, if there is only one 

5 first applicant, or, in the case of more 

6 than one first applicant, 33 months 

7 have passed since the date of submis8 sion of all such applications. 

9 ‘‘(CC) Approval of an application 

10 for the drug submitted by at least one 

11 first applicant would not be precluded 

12 under clause (iii).’’. 

13 (b) INFORMATION.—Not later than 60 days of the date 

14 of enactment of this Act, the Secretary of Health and 

15 Human Services (referred to in this subsection as the ‘‘Sec16 retary’’) shall publish, as appropriate and available, infor17 mation sufficient to allow applicants to assess whether the 

18 conditions described in subitems (AA) through (CC) of sec19 tion 505(j)(5)(B)(iv)(I)(bb) of the Federal Food, Drug, and 

20 Cosmetic Act (as amended by subsection (a)) have been or 

21 will be satisfied for all applications where the exclusivity 

22 period under (iv)(I) of section 505(j)(5)(B) of the Federal 

23 Food, Drug, and Cosmetic Act (as so amended) has not ex24 pired, and shall provide updates to reflect the most recent 

25 information available to the Secretary. 


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1 SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS. 

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

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

4 at the end the following: 

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

6 ‘‘(a) INTERNET WEBSITE.— 

7 ‘‘(1) IN GENERAL.—The Secretary may main8 tain and operate an internet website to provide edu9 cational materials for health care providers, patients, 

10 and caregivers, regarding the meaning of the terms, 

11 and the standards for review and licensing of, biologi12 cal products, including biosimilar biological products 

13 and interchangeable biosimilar biological products. 

14 ‘‘(2) CONTENT.—Educational materials provided 

15 under paragraph (1) may include— 

16 ‘‘(A) explanations of key statutory and reg17 ulatory terms, including ‘biosimilar’ and ‘inter18 changeable’, and clarification regarding the use 

19 of interchangeable biosimilar biological products; 

20 ‘‘(B) information related to development 

21 programs for biological products, including bio22 similar biological products and interchangeable 

23 biosimilar biological products and relevant clin24 ical considerations for prescribers, which may 

25 include, as appropriate and applicable, informaVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00248 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 tion related to the comparability of such biologi2 cal products; 

3 ‘‘(C) an explanation of the process for re4 porting adverse events for biological products, in5 cluding biosimilar biological products and inter6 changeable biosimilar biological products; and 

7 ‘‘(D) an explanation of the relationship be8 tween biosimilar biological products and inter9 changeable biosimilar biological products li10 censed under section 351(k) and reference prod11 ucts (as defined in section 351(i)), including the 

12 standards for review and licensing of each such 

13 type of biological product. 

14 ‘‘(3) FORMAT.—The educational materials pro15 vided under paragraph (1) may be— 

16 ‘‘(A) in formats such as webinars, con17 tinuing medical education modules, videos, fact 

18 sheets, infographics, stakeholder toolkits, or other 

19 formats as appropriate and applicable; and 

20 ‘‘(B) tailored for the unique needs of health 

21 care providers, patients, caregivers, and other 

22 audiences, as the Secretary determines appro23 priate. 


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

2 information described in paragraph (2), the Secretary 

3 shall continue to publish the following information: 

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

5 product licensed under subsection (a) or (k). 

6 ‘‘(B) The summary review of each biological 

7 product licensed under subsection (a) or (k). 

8 ‘‘(5) CONFIDENTIAL AND TRADE SECRET INFOR9 MATION.—This subsection does not authorize the dis10 closure of any trade secret, confidential commercial or 

11 financial information, or other matter described in 

12 section 552(b) of title 5. 

13 ‘‘(b) CONTINUING EDUCATION.—The Secretary shall 

14 advance education and awareness among health care pro15 viders regarding biological products, including biosimilar 

16 biological products and interchangeable biosimilar biologi17 cal products, as appropriate, including by developing or 

18 improving continuing medical education programs that ad19 vance the education of such providers on the prescribing of, 

20 and relevant clinical considerations with respect to, biologi21 cal products, including biosimilar biological products and 

22 interchangeable biosimilar biological products.’’. 

23 SEC. 207. BIOLOGICAL PRODUCT INNOVATION. 

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

25 U.S.C. 262(j)) is amended— 


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1 (1) by striking ‘‘except that a product’’ and in2 serting ‘‘except that— 

3 ‘‘(1) a product’’; 

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

5 and 

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

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

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

9 of such Act), or other reference in such Act to an offi10 cial compendium (as so defined), shall apply with re11 spect to a biological product subject to regulation 

12 under this section.’’. 

13 SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL 

14 ENTITY. 

15 (a) IN GENERAL.—Chapter V of the Federal Food, 

16 Drug, and Cosmetic Act is amended— 

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

18 (A) in subsection (c)(3)(E), by striking ‘‘ac19 tive ingredient (including any ester or salt of the 

20 active ingredient)’’ each place it appears and in21 serting ‘‘active moiety (as defined by the Sec22 retary in section 314.3 of title 21, Code of Fed23 eral Regulations (or any successor regula24 tions))’’; 


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1 (B) in subsection (j)(5)(F), by striking ‘‘ac2 tive ingredient (including any ester or salt of the 

3 active ingredient)’’ each place it appears and in4 serting ‘‘active moiety (as defined by the Sec5 retary in section 314.3 of title 21, Code of Fed6 eral Regulations (or any successor regula7 tions))’’; 

8 (C) in subsection (l)(2)(A)— 

9 (i) by amending clause (i) to read as 

10 follows: 

11 ‘‘(i) not later than 30 days after the date of 

12 approval of such applications— 

13 ‘‘(I) for a drug, no active moiety (as 

14 defined by the Secretary in section 314.3 of 

15 title 21, Code of Federal Regulations (or 

16 any successor regulations)) of which has 

17 been approved in any other application 

18 under this section; or 

19 ‘‘(II) for a biological product, no active 

20 ingredient of which has been approved in 

21 any other application under section 351 of 

22 the Public Health Service Act; and’’; and 

23 (ii) in clause (ii), by inserting ′′or bio24 logical product′′ before the period; 


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1 (D) by amending subsection (s) to read as 

2 follows: 

3 ‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—The Sec4 retary shall— 

5 ‘‘(1) refer a drug or biological product to a Food 

6 and Drug Administration advisory committee for re7 view at a meeting of such advisory committee prior 

8 to the approval of such drug or biological if it is— 

9 ‘‘(A) a drug, no active moiety (as defined 

10 by the Secretary in section 314.3 of title 21, 

11 Code of Federal Regulations (or any successor 

12 regulations)) of which has been approved in any 

13 other application under this section; or 

14 ‘‘(B) a biological product, no active ingre15 dient of which has been approved in any other 

16 application under section 351 of the Public 

17 Health Service Act; or 

18 ‘‘(2) if the Secretary does not refer a drug or bio19 logical product described in paragraph (1) to a Food 

20 and Drug Administration advisory committee prior 

21 to such approval, provide in the action letter on the 

22 application for the drug or biological product a sum23 mary of the reasons why the Secretary did not refer 

24 the drug or biological product to an advisory com25 mittee prior to approval.’’; and 


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1 (E) in subsection (u)(1), in the matter pre2 ceding subparagraph (A)— 

3 (i) by striking ‘‘active ingredient (in4 cluding any ester or salt of the active ingre5 dient)’’ and inserting ‘‘active moiety (as de6 fined by the Secretary in section 314.3 of 

7 title 21, Code of Federal Regulations (or 

8 any successor regulations))’’; and 

9 (ii) by striking ‘‘same active ingre10 dient’’ and inserting ‘‘same active moiety’’; 

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

12 360b(c)(2)(F)), by striking ‘‘active ingredient (includ13 ing any ester or salt of the active ingredient)’’ each 

14 place it appears and inserting ‘‘active moiety (as de15 fined by the Secretary in section 314.3 of title 21, 

16 Code of Federal Regulations (or any successor regula17 tions))’’; 

18 (3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), 

19 by amending subparagraph (C) to read as follows: 

20 ‘‘(C) is for— 

21 ‘‘(i) a human drug, no active moiety 

22 (as defined by the Secretary in section 

23 314.3 of title 21, Code of Federal Regula24 tions (or any successor regulations)) of 


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1 which has been approved in any other ap2 plication under section 505(b)(1); or 

3 ‘‘(ii) a biological product, no active in4 gredient of which has been approved in any 

5 other application under section 351 of the 

6 Public Health Service Act.’’; 

7 (4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 

8 360ff(a)(4)), by striking subparagraphs (A) and (B) 

9 and inserting the following: 

10 ‘‘(A) is for a drug or biological product that 

11 is for the prevention or treatment of a rare pedi12 atric disease; 

13 ‘‘(B)(i) is for such a drug— 

14 ‘‘(I) that contains no active moiety (as 

15 defined by the Secretary in section 314.3 of 

16 title 21, Code of Federal Regulations (or 

17 any successor regulations)) that has been 

18 previously approved in any other applica19 tion under subsection (b)(1), (b)(2), or (j) of 

20 section 505; and 

21 ‘‘(II) that is the subject of an applica22 tion submitted under section 505(b)(1); or 

23 ‘‘(ii) or is for such a biological product— 

24 ‘‘(I) that contains no active ingredient 

25 that has been previously approved in any 


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1 other application under section 351(a) or 

2 351(k) of the Public Health Service Act; 

3 and 

4 ‘‘(II) that is the subject of an applica5 tion submitted under section 351(a) of the 

6 Public Health Service Act;’’; and 

7 (5) in section 565A(a)(4) (21 U.S.C. 360bbb– 

8 4a(a)(4)), by amending subparagraph (D) to read as 

9 follows: 

10 ‘‘(D) is for— 

11 ‘‘(i) a human drug, no active moiety 

12 (as defined by the Secretary in section 

13 314.3 of title 21, Code of Federal Regula14 tions (or any successor regulations)) of 

15 which has been approved in any other ap16 plication under section 505(b)(1); or 

17 ‘‘(ii) a biological product, no active in18 gredient of which has been approved in any 

19 other application under section 351 of the 

20 Public Health Service Act.’’. 

21 (b) TECHNICAL CORRECTIONS.—Chapter V of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq) 

23 is amended— 

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


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1 (A) in subsection (c)(3)(E), by repealing 

2 clause (i); and 

3 (B) in subsection (j)(5)(F), by repealing 

4 clause (i); and 

5 (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 

6 355a(c)(1)(A)(i)), by striking ‘‘(c)(3)(D)’’ and insert7 ing ‘‘(c)(3)(E)’’. 

8 SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL 

9 PRODUCTS. 

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

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

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

13 to an application for a biological product submitted under 

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

15 (21 U.S.C. 355(b)) with a filing date that is not later than 

16 September 23, 2019, and that does not receive final ap17 proval on or before March 23, 2020, such application shall 

18 be deemed to be withdrawn and the Secretary shall refund 

19 the fee paid under section 736(a)(1)(B) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(B)). Not21 withstanding any such withdrawal of the drug application, 

22 the Secretary shall consider any previously conducted sci23 entific review and accelerate review of any such subsequent 

24 application with respect to such biological product under 

25 section 351 of the Public Health Service Act (42 U.S.C. 


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1 262). The Secretary shall provide additional assistance to 

2 the sponsor or manufacturer of such application.’’. 

3 SEC. 210. ORPHAN DRUG CLARIFICATION. 

4 Section 527(c) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 360cc(c)) is amended by adding at 

6 the end the following: 

7 ‘‘(3) APPLICABILITY.—This subsection applies to 

8 any drug designated under section 526 for which an 

9 application was approved under section 505 of this 

10 Act or licensed under section 351 of the Public Health 

11 Service Act after the date of enactment of the FDA 

12 Reauthorization Act of 2017, regardless of the date of 

13 on which such drug was designated under section 

14 526.’’. 

15 SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO SAFE16 TY INFORMATION. 

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

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

19 following: 

20 ‘‘(z) PROMPT APPROVAL OF DRUGS WHEN SAFETY IN21 FORMATION IS ADDED TO LABELING.— 

22 ‘‘(1) GENERAL RULE.—A drug for which an ap23 plication has been submitted or approved under sub24 section (b)(2) or (j) shall not be considered ineligible 

25 for approval under this section or misbranded under 


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1 section 502 on the basis that the labeling of the drug 

2 omits safety information, including contraindica3 tions, warnings, precautions, dosing, administration, 

4 or other information pertaining to safety, when the 

5 omitted safety information is protected by exclusivity 

6 under clause (iii) or (iv) of subsection (j)(5)(F), 

7 clause (iii) or (iv) of subsection (c)(3)(E), or section 

8 527(a), or by an extension of such exclusivity under 

9 section 505A or 505E. 

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

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

12 of subsection (c)(3)(E), or section 527, the Secretary 

13 shall require that the labeling of a drug approved 

14 pursuant to an application submitted under sub15 section (b)(2) or (j) that omits safety information de16 scribed in paragraph (1) include a statement of any 

17 appropriate safety information that the Secretary 

18 considers necessary to assure safe use. 

19 ‘‘(3) AVAILABILITY AND SCOPE OF EXCLU20 SIVITY.—This subsection does not affect— 

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

22 or an extension of exclusivity described in sub23 paragraph (A) or (B) of section 505A(o)(3); 

24 ‘‘(B) the question of the eligibility for ap25 proval under this section of any application deVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00259 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 scribed in subsection (b)(2) or (j) that omits any 

2 other aspect of labeling protected by exclusivity 

3 under— 

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

5 (j)(5)(F); 

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

7 (c)(3)(E); or 

8 ‘‘(iii) section 527(a); or 

9 ‘‘(C) except as expressly provided in para10 graphs (1) and (2), the operation of this section 

11 or section 527.’’. 

12 SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGI13 CAL PRODUCTS. 

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

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

16 (1) in subclause (I), by striking ‘‘; and’’ and in17 serting a semicolon; 

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

19 inserting ‘‘; and’’; and 

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

21 ‘‘(III) may include information to 

22 show that the conditions of use pre23 scribed, recommended, or suggested in 

24 the labeling proposed for the biological 


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1 product have been previously approved 

2 for the reference product.’’. 

3 SEC. 213. MODERNIZING THE LABELING OF CERTAIN GE4 NERIC DRUGS. 

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

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

7 section 503C the following: 

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

9 DRUGS. 

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

11 ‘‘(1) The term ‘covered drug’ means a drug ap12 proved under section 505(c)— 

13 ‘‘(A) for which there are no unexpired pat14 ents included in the list under section 505(j)(7) 

15 and no unexpired period of exclusivity; 

16 ‘‘(B) for which the approval of the applica17 tion has been withdrawn for reasons other than 

18 safety or effectiveness; and 

19 ‘‘(C) for which, with respect to the label20 ing— 

21 ‘‘(i) new scientific evidence is available 

22 regarding the conditions of use of the drug; 

23 ‘‘(ii) there is a relevant accepted use in 

24 clinical practice that is not reflected in the 

25 approved labeling; or 


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1 ‘‘(iii) the labeling of such drug does not 

2 reflect current legal and regulatory require3 ments. 

4 ‘‘(2) The term ‘period of exclusivity’, with respect 

5 to a drug approved under section 505(c), means any 

6 period of exclusivity under clause (ii), (iii), or (iv) of 

7 section 505(c)(3)(E), clause (ii), (iii), or (iv) of sec8 tion 505(j)(5)(F), or section 505A, 505E, or 527. 

9 ‘‘(3) The term ‘generic version’ means a drug ap10 proved under section 505(j) whose reference drug is a 

11 covered drug. 

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

13 use for a drug in clinical practice that is supported 

14 by scientific evidence that appears to the Secretary to 

15 meet the standards for approval under section 505. 

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

17 drug for which the Secretary has determined through 

18 the process under subsection (c) that the labeling 

19 should be changed. 

20 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The Sec21 retary may identify covered drugs for which labeling up22 dates would provide a public health benefit. To assist in 

23 identifying covered drugs, the Secretary may do one or both 

24 of the following: 


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1 ‘‘(1) Enter into cooperative agreements or con2 tracts with public or private entities to review the 

3 available scientific evidence concerning such drugs. 

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

5 including input on whether there is a relevant accept6 ed use in clinical practice that is not reflected in the 

7 approved labeling of such drugs or whether new sci8 entific evidence is available regarding the conditions 

9 of use for such drug, by— 

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

11 ‘‘(B) opening a public docket for the sub12 mission of public comments; or 

13 ‘‘(C) other means, as the Secretary deter14 mines appropriate. 

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

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

17 the available scientific evidence meets the standards under 

18 section 505 for adding or modifying information to the la19 beling or providing supplemental information to the label20 ing regarding the use of the covered drug, the Secretary may 

21 initiate the process under subsection (d). 

22 ‘‘(d) INITIATION OF THE PROCESS OF UPDATING.—If 

23 the Secretary determines that labeling changes are appro24 priate for a selected drug pursuant to subsection (c), the 


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1 Secretary shall provide notice to the holders of approved 

2 applications for a generic version of such drug that— 

3 ‘‘(1) summarizes the findings supporting the de4 termination of the Secretary that the available sci5 entific evidence meets the standards under section 505 

6 for adding or modifying information or providing 

7 supplemental information to the labeling of the cov8 ered drug pursuant to subsection (c); 

9 ‘‘(2) provides a clear statement regarding the ad10 ditional, modified, or supplemental information for 

11 such labeling, according to the determination by the 

12 Secretary (including, as applicable, modifications to 

13 add the relevant accepted use to the labeling of the 

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

15 ‘‘(3) states whether the statement under para16 graph (2) applies to the selected drug as a class of 

17 covered drugs or only to a specific drug product. 

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

19 receipt of notification provided by the Secretary pursuant 

20 to subsection (d), the holder of an approved application for 

21 a generic version of the selected drug shall— 

22 ‘‘(1) agree to change the approved labeling to re23 flect the additional, modified, or supplemental infor24 mation the Secretary has determined to be appro25 priate; or 


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

2 approved application does not believe that the re3 quested labeling changes are warranted and submit a 

4 statement detailing the reasons why such changes are 

5 not warranted. 

6 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE7 SPONSE.— 

8 ‘‘(1) IN GENERAL.—Upon receipt of the applica9 tion holder’s response, the Secretary shall promptly 

10 review each statement received under subsection (e)(2) 

11 and determine which labeling changes pursuant to the 

12 Secretary’s notice under subsection (d) are appro13 priate, if any. If the Secretary disagrees with the rea14 sons why such labeling changes are not warranted, the 

15 Secretary shall provide opportunity for discussions 

16 with the application holders to reach agreement on 

17 whether the labeling for the covered drug should be 

18 updated to reflect current scientific evidence, and if 

19 so, the content of such labeling changes. 

20 ‘‘(2) CHANGES TO LABELING.—After considering 

21 all responses from the holder of an approved applica22 tion under paragraph (1) or (2) of subsection (e), and 

23 any discussion under paragraph (1), the Secretary 

24 may order such holder to make the labeling changes 


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1 the Secretary determines are appropriate. Such holder 

2 of an approved application shall— 

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

4 at the next printing of that labeling; 

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

6 drug within 30 days; and 

7 ‘‘(C) submit the revised labeling through the 

8 form, ‘Supplement—Changes Being Effected’. 

9 ‘‘(g) VIOLATION.—If the holder of an approved appli10 cation for the generic version of the selected drug does not 

11 comply with the requirements of subsection (f)(2), such ge12 neric version of the selected drug shall be deemed to be mis13 branded under section 502. 

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

15 ‘‘(1) IN GENERAL.—With respect to any labeling 

16 change required under this section, the generic version 

17 shall be deemed to have the same conditions of use 

18 and the same labeling as a reference drug for pur19 poses of clauses (i) and (v) of section 505(j)(2)(A). 

20 Any labeling change so required shall not have any 

21 legal effect for the applicant that is different than the 

22 legal effect that would have resulted if a supplemental 

23 application had been submitted and approved to con24 form the labeling of the generic version to a change 

25 in the labeling of the reference drug. 


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1 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes to 

2 labeling made in accordance with this paragraph 

3 shall not be eligible for an exclusivity period under 

4 this Act. 

5 ‘‘(i) DRUG PRODUCT CLASSES.—In the case of a se6 lected drug for which the labeling changes ordered by the 

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

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

9 generic versions of such drug in that class. 

10 ‘‘(j) RULES OF CONSTRUCTION.— 

11 ‘‘(1) APPROVAL STANDARDS.—This section shall 

12 not be construed as altering the applicability of the 

13 standards for approval of an application under sec14 tion 505. No order shall be issued under this sub15 section unless the evidence supporting the changed la16 beling meets the standards for approval applicable to 

17 any change to labeling under section 505. 

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

19 this section shall be construed to give the Secretary 

20 additional authority to remove approved indications 

21 for drugs, other than the authority described in this 

22 section. 

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

24 of the enactment of the Lower Health Care Costs Act and 

25 every 4 years thereafter, the Secretary shall prepare and 


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1 submit to the Committee on Health, Education, Labor, and 

2 Pensions of the Senate and the Committee on Energy and 

3 Commerce of the House of Representatives, a report that— 

4 ‘‘(1) describes the actions of the Secretary under 

5 this section, including— 

6 ‘‘(A) the number of covered drugs and de7 scription of the types of drugs the Secretary has 

8 selected for labeling changes and the rationale for 

9 such recommended changes; and 

10 ‘‘(B) the number of times the Secretary en11 tered into discussions concerning a disagreement 

12 with an application holder or holders and a 

13 summary of the decision regarding a labeling 

14 change, if any; and 

15 ‘‘(2) includes any recommendations of the Sec16 retary for modifying the program under this sec17 tion.’’. 

18 SEC. 214. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 

19 BIOSIMILAR BIOLOGICAL PRODUCTS. 

20 (a) DEFINITIONS.—In this section— 

21 (1) the term ‘‘commercially reasonable, market22 based terms’’ means— 

23 (A) a nondiscriminatory price for the sale 

24 of the covered product at or below, but not great25 er than, the most recent wholesale acquisition 


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1 cost for the drug, as defined in section 

2 1847A(c)(6)(B) of the Social Security Act (42 

3 U.S.C. 1395w–3a(c)(6)(B)); 

4 (B) a schedule for delivery that results in 

5 the transfer of the covered product to the eligible 

6 product developer consistent with the timing 

7 under subsection (b)(2)(A)(iv); and 

8 (C) no additional conditions are imposed 

9 on the sale of the covered product; 

10 (2) the term ‘‘covered product’’— 

11 (A) means— 

12 (i) any drug approved under sub13 section (c) or (j) of section 505 of the Fed14 eral Food, Drug, and Cosmetic Act (21 

15 U.S.C. 355) or biological product licensed 

16 under subsection (a) or (k) of section 351 of 

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

18 262); 

19 (ii) any combination of a drug or bio20 logical product described in clause (i); or 

21 (iii) when reasonably necessary to sup22 port approval of an application under sec23 tion 505 of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 355), or section 

25 351 of the Public Health Service Act (42 


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1 U.S.C. 262), as applicable, or otherwise 

2 meet the requirements for approval under 

3 either such section, any product, including 

4 any device, that is marketed or intended for 

5 use with such a drug or biological product; 

6 and 

7 (B) does not include any drug or biological 

8 product that appears on the drug shortage list in 

9 effect under section 506E of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 356e), un11 less— 

12 (i) the drug or biological product has 

13 been on the drug shortage list in effect 

14 under such section 506E continuously for 

15 more than 6 months; or 

16 (ii) the Secretary determines that in17 clusion of the drug or biological product as 

18 a covered product is likely to contribute to 

19 alleviating or preventing a shortage. 

20 (3) the term ‘‘device’’ has the meaning given the 

21 term in section 201 of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 321); 

23 (4) the term ‘‘eligible product developer’’ means 

24 a person that seeks to develop a product for approval 

25 pursuant to an application for approval under subVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00270 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 section (b)(2) or (j) of section 505 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or for 

3 licensing pursuant to an application under section 

4 351(k) of the Public Health Service Act (42 U.S.C. 

5 262(k)); 

6 (5) the term ‘‘license holder’’ means the holder of 

7 an application approved under subsection (c) or (j) of 

8 section 505 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 355) or the holder of a license under 

10 subsection (a) or (k) of section 351 of the Public 

11 Health Service Act (42 U.S.C. 262) for a covered 

12 product; 

13 (6) the term ‘‘REMS’’ means a risk evaluation 

14 and mitigation strategy under section 505–1 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355–1); 

17 (7) the term ‘‘REMS with ETASU’’ means a 

18 REMS that contains elements to assure safe use under 

19 section 505–1(f) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355–1(f)); 

21 (8) the term ‘‘Secretary’’ means the Secretary of 

22 Health and Human Services; 

23 (9) the term ‘‘single, shared system of elements to 

24 assure safe use’’ means a single, shared system of ele25 ments to assure safe use under section 505–1(f) of the 


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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 355–1(f)); and 

3 (10) the term ‘‘sufficient quantities’’ means an 

4 amount of a covered product that the eligible product 

5 developer determines allows it to— 

6 (A) conduct testing to support an applica7 tion under— 

8 (i) subsection (b)(2) or (j) of section 

9 505 of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 355); or 

11 (ii) section 351(k) of the Public Health 

12 Service Act (42 U.S.C. 262(k)); and 

13 (B) fulfill any regulatory requirements re14 lating to approval of such an application. 

15 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI16 CIENT QUANTITIES OF A COVERED PRODUCT.— 

17 (1) IN GENERAL.—An eligible product developer 

18 may bring a civil action against the license holder for 

19 a covered product seeking relief under this subsection 

20 in an appropriate district court of the United States 

21 alleging that the license holder has declined to provide 

22 sufficient quantities of the covered product to the eli23 gible product developer on commercially reasonable, 

24 market-based terms. 

25 (2) ELEMENTS.— 


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1 (A) IN GENERAL.—To prevail in a civil ac2 tion brought under paragraph (1), an eligible 

3 product developer shall prove, by a preponder4 ance of the evidence— 

5 (i) that— 

6 (I) the covered product is not sub7 ject to a REMS with ETASU; or 

8 (II) if the covered product is sub9 ject to a REMS with ETASU— 

10 (aa) the eligible product de11 veloper has obtained a covered 

12 product authorization from the 

13 Secretary in accordance with sub14 paragraph (B); and 

15 (bb) the eligible product de16 veloper has provided a copy of the 

17 covered product authorization to 

18 the license holder; 

19 (ii) that, as of the date on which the 

20 civil action is filed, the product developer 

21 has not obtained sufficient quantities of the 

22 covered product on commercially reasonable, 

23 market-based terms; 

24 (iii) that the eligible product developer 

25 has submitted a written request to purchase 


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1 sufficient quantities of the covered product 

2 to the license holder, and such request— 

3 (I) was sent to a named corporate 

4 officer of the license holder; 

5 (II) was made by certified or reg6 istered mail with return receipt re7 quested; 

8 (III) specified an individual as 

9 the point of contact for the license 

10 holder to direct communications re11 lated to the sale of the covered product 

12 to the eligible product developer and a 

13 means for electronic and written com14 munications with that individual; and 

15 (IV) specified an address to which 

16 the covered product was to be shipped 

17 upon reaching an agreement to trans18 fer the covered product; and 

19 (iv) that the license holder has not de20 livered to the eligible product developer suf21 ficient quantities of the covered product on 

22 commercially reasonable, market-based 

23 terms— 

24 (I) for a covered product that is 

25 not subject to a REMS with ETASU, 


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1 by the date that is 31 days after the 

2 date on which the license holder re3 ceived the request for the covered prod4 uct; and 

5 (II) for a covered product that is 

6 subject to a REMS with ETASU, by 

7 31 days after the later of— 

8 (aa) the date on which the li9 cense holder received the request 

10 for the covered product; or 

11 (bb) the date on which the li12 cense holder received a copy of the 

13 covered product authorization 

14 issued by the Secretary in accord15 ance with subparagraph (B). 

16 (B) AUTHORIZATION FOR COVERED PROD17 UCT SUBJECT TO A REMS WITH ETASU.— 

18 (i) REQUEST.—An eligible product de19 veloper may submit to the Secretary a writ20 ten request for the eligible product developer 

21 to be authorized to obtain sufficient quan22 tities of an individual covered product sub23 ject to a REMS with ETASU. 

24 (ii) AUTHORIZATION.—Not later than 

25 120 days after the date on which a request 


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1 under clause (i) is received, the Secretary 

2 shall, by written notice, authorize the eligi3 ble product developer to obtain sufficient 

4 quantities of an individual covered product 

5 subject to a REMS with ETASU for pur6 poses of— 

7 (I) development and testing that 

8 does not involve human clinical trials, 

9 if the eligible product developer has 

10 agreed to comply with any conditions 

11 the Secretary determines necessary; or 

12 (II) development and testing that 

13 involves human clinical trials, if the 

14 eligible product developer has— 

15 (aa)(AA) submitted protocols, 

16 informed consent documents, and 

17 informational materials for test18 ing that include protections that 

19 provide safety protections com20 parable to those provided by the 

21 REMS for the covered product; or 

22 (BB) otherwise satisfied the 

23 Secretary that such protections 

24 will be provided; and 


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1 (bb) met any other require2 ments the Secretary may estab3 lish. 

4 (iii) NOTICE.—A covered product au5 thorization issued under this subparagraph 

6 shall state that the provision of the covered 

7 product by the license holder under the 

8 terms of the authorization will not be a vio9 lation of the REMS for the covered product. 

10 (3) AFFIRMATIVE DEFENSE.—In a civil action 

11 brought under paragraph (1), it shall be an affirma12 tive defense, on which the defendant has the burden 

13 of persuasion by a preponderance of the evidence— 

14 (A) that, on the date on which the eligible 

15 product developer requested to purchase sufficient 

16 quantities of the covered product from the license 

17 holder— 

18 (i) neither the license holder nor any of 

19 its agents, wholesalers, or distributors was 

20 engaged in the manufacturing or commer21 cial marketing of the covered product; and 

22 (ii) neither the license holder nor any 

23 of its agents, wholesalers, or distributors 

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1 uct developer on commercially reasonable, 

2 market-based terms; 

3 (B) that— 

4 (i) the license holder sells the covered 

5 product through agents, distributors, or 

6 wholesalers; 

7 (ii) the license holder has placed no re8 strictions, explicit or implicit, on its agents, 

9 distributors, or wholesalers to sell covered 

10 products to eligible product developers; and 

11 (iii) the covered product can be pur12 chased by the eligible product developer in 

13 sufficient quantities on commercially rea14 sonable, market-based terms from the 

15 agents, distributors, or wholesalers of the li16 cense holder; or 

17 (C) that the license holder made an offer to 

18 the individual specified pursuant to paragraph 

19 (2)(A)(iii)(III), by a means of communication 

20 (electronic, written, or both) specified pursuant 

21 to such paragraph, to sell sufficient quantities of 

22 the covered product to the eligible product devel23 oper at commercially reasonable market-based 

24 terms— 


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1 (i) for a covered product that is not 

2 subject to a REMS with ETASU, by the 

3 date that is 14 days after the date on which 

4 the license holder received the request for the 

5 covered product, and the eligible product de6 veloper did not accept such offer by the date 

7 that is 7 days after the date on which the 

8 eligible product developer received such offer 

9 from the license holder; or 

10 (ii) for a covered product that is sub11 ject to a REMS with ETASU, by the date 

12 that is 20 days after the date on which the 

13 license holder received the request for the 

14 covered product, and the eligible product de15 veloper did not accept such offer by the date 

16 that is 10 days after the date on which the 

17 eligible product developer received such offer 

18 from the license holder. 

19 (4) REMEDIES.— 

20 (A) IN GENERAL.—If an eligible product de21 veloper prevails in a civil action brought under 

22 paragraph (1), the court shall— 

23 (i) order the license holder to provide 

24 to the eligible product developer without 

25 delay sufficient quantities of the covered 


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1 product on commercially reasonable, mar2 ket-based terms; 

3 (ii) award to the eligible product devel4 oper reasonable attorney’s fees and costs of 

5 the civil action; and 

6 (iii) award to the eligible product de7 veloper a monetary amount sufficient to 

8 deter the license holder from failing to pro9 vide eligible product developers with suffi10 cient quantities of a covered product on 

11 commercially reasonable, market-based 

12 terms, if the court finds, by a preponder13 ance of the evidence— 

14 (I) that the license holder delayed 

15 providing sufficient quantities of the 

16 covered product to the eligible product 

17 developer without a legitimate business 

18 justification; or 

19 (II) that the license holder failed 

20 to comply with an order issued under 

21 clause (i). 

22 (B) MAXIMUM MONETARY AMOUNT.—A 

23 monetary amount awarded under subparagraph 

24 (A)(iii) shall not be greater than the revenue that 


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1 the license holder earned on the covered product 

2 during the period— 

3 (i) beginning on— 

4 (I) for a covered product that is 

5 not subject to a REMS with ETASU, 

6 the date that is 31 days after the date 

7 on which the license holder received the 

8 request; or 

9 (II) for a covered product that is 

10 subject to a REMS with ETASU, the 

11 date that is 31 days after the later of— 

12 (aa) the date on which the li13 cense holder received the request; 

14 or 

15 (bb) the date on which the li16 cense holder received a copy of the 

17 covered product authorization 

18 issued by the Secretary in accord19 ance with paragraph (2)(B); and 

20 (ii) ending on the date on which the el21 igible product developer received sufficient 

22 quantities of the covered product. 

23 (C) AVOIDANCE OF DELAY.—The court may 

24 issue an order under subparagraph (A)(i) before 

25 conducting further proceedings that may be necVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00281 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 essary to determine whether the eligible product 

2 developer is entitled to an award under clause 

3 (ii) or (iii) of subparagraph (A), or the amount 

4 of any such award. 

5 (c) LIMITATION OF LIABILITY.—A license holder for a 

6 covered product shall not be liable for any claim under Fed7 eral, State, or local law arising out of the failure of an 

8 eligible product developer to follow adequate safeguards to 

9 assure safe use of the covered product during development 

10 or testing activities described in this section, including 

11 transportation, handling, use, or disposal of the covered 

12 product by the eligible product developer. 

13 (d) NO VIOLATION OF REMS.—Section 505–1 of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) 

15 is amended by adding at the end the following new sub16 section: 

17 ‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF

18 STRATEGY.—The provision of samples of a covered product 

19 to an eligible product developer (as those terms are defined 

20 in section 214(a) of the Lower Health Care Costs Act) shall 

21 not be considered a violation of the requirements of any risk 

22 evaluation and mitigation strategy that may be in place 

23 under this section for such drug.’’. 

24 (e) RULE OF CONSTRUCTION.— 


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1 (1) DEFINITION.—In this subsection, the term 

2 ‘‘antitrust laws’’— 

3 (A) has the meaning given the term in sub4 section (a) of the first section of the Clayton Act 

5 (15 U.S.C. 12); and 

6 (B) includes section 5 of the Federal Trade 

7 Commission Act (15 U.S.C. 45) to the extent that 

8 such section applies to unfair methods of com9 petition. 

10 (2) ANTITRUST LAWS.—Nothing in this section 

11 shall be construed to limit the operation of any provi12 sion of the antitrust laws. 

13 (f) REMS APPROVAL PROCESS FOR SUBSEQUENT FIL14 ERS.—Section 505–1 of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355–1), as amended by subsection (d), 

16 is further amended— 

17 (1) in subsection (g)(4)(B)— 

18 (A) in clause (i) by striking ‘‘or’’ after the 

19 semicolon; 

20 (B) in clause (ii) by striking the period at 

21 the end and inserting ‘‘; or’’; and 

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

23 ‘‘(iii) accommodate different, com24 parable aspects of the elements to assure 

25 safe use for a drug that is the subject of an 


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1 application under section 505(j), and the 

2 applicable listed drug.’’; 

3 (2) in subsection (i)(1), by striking subpara4 graph (C) and inserting the following: 

5 ‘‘(C)(i) Elements to assure safe use, if re6 quired under subsection (f) for the listed drug, 

7 which, subject to clause (ii), for a drug that is 

8 the subject of an application under section 505(j) 

9 may use— 

10 ‘‘(I) a single, shared system with the 

11 listed drug under subsection (f); or 

12 ‘‘(II) a different, comparable aspect of 

13 the elements to assure safe use under sub14 section (f). 

15 ‘‘(ii) The Secretary may require a drug that 

16 is the subject of an application under section 

17 505(j) and the listed drug to use a single, shared 

18 system under subsection (f), if the Secretary de19 termines that no different, comparable aspect of 

20 the elements to assure safe use could satisfy the 

21 requirements of subsection (f).’’; 

22 (3) in subsection (i), by adding at the end the 

23 following: 

24 ‘‘(3) SHARED REMS.—If the Secretary approves, 

25 in accordance with paragraph (1)(C)(i)(II), a difVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00284 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 ferent, comparable aspect of the elements to assure 

2 safe use under subsection (f) for a drug that is the 

3 subject of an abbreviated new drug application under 

4 section 505(j), the Secretary may require that such 

5 different comparable aspect of the elements to assure 

6 safe use can be used with respect to any other drug 

7 that is the subject of an application under section 

8 505(j) or 505(b) that references the same listed drug.’’; 

9 and 

10 (4) by adding at the end the following: 

11 ‘‘(m) SEPARATE REMS.—When used in this section, 

12 the terms ‘different, comparable aspect of the elements to 

13 assure safe use’ or ‘different, comparable approved risk eval14 uation and mitigation strategies’ means a risk evaluation 

15 and mitigation strategy for a drug that is the subject of 

16 an application under section 505(j) that uses different 

17 methods or operational means than the strategy required 

18 under subsection (a) for the applicable listed drug, or other 

19 application under section 505(j) with the same such listed 

20 drug, but achieves the same level of safety as such strategy.’’. 

21 (g) RULE OF CONSTRUCTION.—Nothing in this section, 

22 the amendments made by this section, or in section 505– 

23 1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 355–1), shall be construed as— 


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1 (1) prohibiting a license holder from providing 

2 an eligible product developer access to a covered prod3 uct in the absence of an authorization under this sec4 tion; or 

5 (2) in any way negating the applicability of a 

6 REMS with ETASU, as otherwise required under 

7 such section 505–1, with respect to such covered prod8 uct. 

9 SEC. 215. REDUCING THE PRICE OF PRESCRIPTION DRUGS. 

10 Title III of the Public Health Service Act (42 U.S.C. 

11 241 et seq.) is amended by adding at the end the following: 

12 ‘‘PART W—DRUG PRICE REPORTING; DRUG VALUE 

13 FUND 

14 ‘‘SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG 

15 PRICE INCREASES. 

16 ‘‘(a) DEFINITIONS.—In this section: 

17 ‘‘(1) MANUFACTURER.—The term ‘manufacturer’ 

18 means the person— 

19 ‘‘(A) that holds the application for a drug 

20 approved under section 505 of the Federal Food, 

21 Drug, and Cosmetic Act or the license issued 

22 under section 351 of this Act; or 

23 ‘‘(B) who is responsible for setting the price 

24 for the drug. 


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1 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 

2 drug’ means any drug that is approved under sub3 section (c) or (j) of section 505 of the Federal Food, 

4 Drug, and Cosmetic Act or licensed under subsection 

5 (a) or (k) of section 351 of this Act— 

6 ‘‘(A) that has a wholesale acquisition cost of 

7 $100 or more per month supply, or per a course 

8 of treatment that lasts less than a month, and 

9 is— 

10 ‘‘(i)(I) subject to section 503(b)(1) of 

11 the Federal Food, Drug, and Cosmetic Act; 

12 or 

13 ‘‘(II) commonly administered by hos14 pitals (as determined by the Secretary); and 

15 ‘‘(ii) not designated by the Secretary 

16 as a vaccine; and 

17 ‘‘(B) for which, during the previous cal18 endar year, at least 1 dollar of the total amount 

19 of sales were for individuals enrolled under the 

20 Medicare program under title XVIII of the So21 cial Security Act (42 U.S.C. 1395 et seq.) or 

22 under a State Medicaid plan under title XIX of 

23 such Act (42 U.S.C. 1396 et seq.) or under a 

24 waiver of such plan. 


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1 ‘‘(3) WHOLESALE ACQUISITION COST.—The term 

2 ‘wholesale acquisition cost’ has the meaning given 

3 that term in section 1847A(c)(6)(B) of the Social Se4 curity Act (42 U.S.C. 1395w–3a(c)(6)(B)). 

5 ‘‘(b) REPORT.— 

6 ‘‘(1) REPORT REQUIRED.—The manufacturer of 

7 a qualifying drug shall submit a report to the Sec8 retary for each price increase of a qualifying drug 

9 that will result in an increase in the wholesale acqui10 sition cost of that drug that is equal to— 

11 ‘‘(A) 10 percent or more over a 12-month 

12 period; or 

13 ‘‘(B) 25 percent or more over a 36-month 

14 period. 

15 ‘‘(2) REPORT DEADLINE.—Each report described 

16 in paragraph (1) shall be submitted to the Secretary 

17 not later than 30 days prior to the planned effective 

18 date of such price increase. 

19 ‘‘(c) CONTENTS.—A report under subsection (b) shall, 

20 at a minimum, include— 

21 ‘‘(1) with respect to the qualifying drug— 

22 ‘‘(A) the percentage by which the manufac23 turer will raise the wholesale acquisition cost of 

24 the drug on the planned effective date of such 

25 price increase; 


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1 ‘‘(B) a justification for, and description of, 

2 each manufacturer’s price increase that will 

3 occur during the 12-month period described in 

4 subsection (b)(1)(A) or the 36-month period de5 scribed in subsection (b)(1)(B), as applicable; 

6 ‘‘(C) the identity of the initial developer of 

7 the drug; 

8 ‘‘(D) a description of the history of the 

9 manufacturer’s price increases for the drug since 

10 the approval of the application for the drug 

11 under section 505 of the Federal Food, Drug, 

12 and Cosmetic Act or the issuance of the license 

13 for the drug under section 351, or since the man14 ufacturer acquired such approved application or 

15 license; 

16 ‘‘(E) the current list price of the drug; 

17 ‘‘(F) the total expenditures of the manufac18 turer on— 

19 ‘‘(i) materials and manufacturing for 

20 such drug; and 

21 ‘‘(ii) acquiring patents and licensing 

22 for such drug; 

23 ‘‘(G) the percentage of total expenditures of 

24 the manufacturer on research and development 


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1 for such drug that was derived from Federal 

2 funds; 

3 ‘‘(H) the total expenditures of the manufac4 turer on research and development for such drug 

5 that is used for— 

6 ‘‘(i) basic and preclinical research; 

7 ‘‘(ii) clinical research; 

8 ‘‘(iii) new drug development; 

9 ‘‘(iv) pursuing new or expanded indi10 cations for such drug through supplemental 

11 applications under section 505 of the Fed12 eral Food, Drug, and Cosmetic Act or sec13 tion 351 of this Act; and 

14 ‘‘(v) carrying out postmarket require15 ments related to such drug, including those 

16 under section 505(o)(3) of the Federal Food, 

17 Drug, and Cosmetic Act; 

18 ‘‘(I) the total revenue and the net profit 

19 generated from the qualifying drug for each cal20 endar year since the approval of the application 

21 for the drug under section 505 of the Federal 

22 Food, Drug, and Cosmetic Act or the issuance of 

23 the license for the drug under section 351, or 

24 since the manufacturer acquired such approved 

25 application or license; and 


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1 ‘‘(J) the total costs associated with mar2 keting and advertising for the qualifying drug; 

3 ‘‘(2) with respect to the manufacturer— 

4 ‘‘(A) the total revenue and the net profit of 

5 the manufacturer— 

6 ‘‘(i) for the 12-month period preceding 

7 the date of the report, in the case of a report 

8 based on an increase described in subsection 

9 (b)(1)(A); or 

10 ‘‘(ii) for the 36-month period preceding 

11 the date of the report, in the case of a report 

12 based on an increase described in subsection 

13 (b)(1)(B); 

14 ‘‘(B) all stock-based performance metrics 

15 used by the manufacturer to determine executive 

16 compensation— 

17 ‘‘(i) for the12-month period preceding 

18 the date of the report, in the case of a report 

19 based on an increase described in subsection 

20 (b)(1)(A); or 

21 ‘‘(ii) for the 36-month period preceding 

22 the date of the report, in the case of a report 

23 based on an increase described in subsection 

24 (b)(1)(B); and 


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1 ‘‘(C) any additional information the manu2 facturer chooses to provide related to drug pric3 ing decisions, such as total expenditures on— 

4 ‘‘(i) drug research and development; or 

5 ‘‘(ii) clinical trials on drugs that failed 

6 to receive approval by the Food and Drug 

7 Administration; and 

8 ‘‘(3) such other related information as the Sec9 retary considers appropriate, as specified through no10 tice and comment rulemaking. 

11 ‘‘(d) CIVIL PENALTY.—Any manufacturer of a quali12 fying drug that fails to submit a report for the drug as 

13 required by this section shall be subject to a civil penalty 

14 of $100,000 for each day on which the violation continues. 

15 ‘‘(e) PUBLIC POSTING.— 

16 ‘‘(1) IN GENERAL.—Subject to paragraph (3), 

17 not later than 30 days after the submission of a re18 port under subsection (b), the Secretary shall post the 

19 report on the public website of the Department of 

20 Health and Human Services. 

21 ‘‘(2) FORMAT.—In developing the format of such 

22 report for public posting, the Secretary shall consult 

23 stakeholders, including beneficiary groups, and shall 

24 seek feedback on the content and format from con25 sumer advocates and readability experts to ensure 


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1 such public reports are user-friendly to the public and 

2 are written in plain language that consumers can 

3 readily understand. 

4 ‘‘(3) TRADE SECRETS AND CONFIDENTIAL INFOR5 MATION.—In carrying out this section the Secretary 

6 shall enforce current law concerning the protection of 

7 confidential commercial information and trade se8 crets.’’. 

9 ‘‘SEC. 399OO–1. USE OF CIVIL PENALTY AMOUNTS. 

10 ‘‘The Secretary shall, without further appropriation, 

11 collect civil penalties under section 399OO and use the 

12 funds derived from such civil penalties, in addition to any 

13 other amounts available to the Secretary, to carry out ac14 tivities described in this part and to improve consumer and 

15 provider information about drug value and drug price 

16 transparency. 

17 ‘‘SEC. 399OO–2. ANNUAL REPORT TO CONGRESS. 

18 ‘‘(a) IN GENERAL.—Subject to subsection (b), the Sec19 retary shall submit to Congress, and post on the public 

20 website of the Department of Health and Human Services 

21 in a way that is easy to find, use, and understand, an an22 nual report— 

23 ‘‘(1) summarizing the information reported pur24 suant to section 399OO; and 


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1 ‘‘(2) including copies of the reports and sup2 porting detailed economic analyses submitted pursu3 ant to such section. 

4 ‘‘(b) TRADE SECRETS AND CONFIDENTIAL INFORMA5 TION.—In carrying out this section the Secretary shall en6 force current law concerning the protection of confidential 

7 commercial information and trade secrets.’’. 

8 TITLE III—IMPROVING TRANS9 PARENCY IN HEALTH CARE 

10 SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG 

11 CLAUSES ON PRICE AND QUALITY INFORMA12 TION. 

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

14 Health Service Act (42 U.S.C. 300gg–11 et seq.), as amend15 ed by section 103, is amended by adding at the end the 

16 following: 

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

18 GAG CLAUSES ON PRICE AND QUALITY IN19 FORMATION. 

20 ‘‘(a) INCREASING PRICE AND QUALITY TRANSPARENCY

21 FOR PLAN SPONSORS AND GROUP AND INDIVIDUAL MAR22 KET AND CONSUMERS.— 

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

24 plan or health insurance issuer offering group health 

25 insurance coverage may not enter into an agreement 


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1 with a health care provider, network or association of 

2 providers, third-party administrator, or other service 

3 provider offering access to a network of providers that 

4 would directly or indirectly restrict a group health 

5 plan or health insurance issuer from— 

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

7 quality of care information, through a consumer 

8 engagement tool or any other means, to referring 

9 providers, the plan sponsor, enrollees, or eligible 

10 enrollees of the plan or coverage; 

11 ‘‘(B) electronically accessing de-identified 

12 claims and encounter data for each enrollee in 

13 the plan or coverage, upon request and consistent 

14 with the privacy regulations promulgated pursu15 ant to section 264(c) of the Health Insurance 

16 Portability and Accountability Act, the amend17 ments to this Act made by the Genetic Informa18 tion Nondiscrimination Act of 2008, and the 

19 Americans with Disabilities Act of 1990, with 

20 respect to the applicable health plan or health 

21 insurance coverage, including, on a per claim 

22 basis— 

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

24 allowed amount, or any other claim-related 


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1 financial obligations included in the pro2 vider contract; 

3 ‘‘(ii) provider information, including 

4 name and clinical designation; 

5 ‘‘(iii) service codes; or 

6 ‘‘(iv) any other data element normally 

7 included in claim or encounter transactions 

8 when received by a plan or issuer; or 

9 ‘‘(C) sharing data described in subpara10 graph (A) or (B) with a business associate as de11 fined in section 160.103 of title 45, Code of Fed12 eral Regulations (or successor regulations), con13 sistent with the privacy regulations promulgated 

14 pursuant to section 264(c) of the Health Insur15 ance Portability and Accountability Act, the 

16 amendments to this Act made by the Genetic In17 formation Nondiscrimination Act of 2008, and 

18 the Americans with Disabilities Act of 1990. 

19 ‘‘(2) INDIVIDUAL HEALTH INSURANCE COV20 ERAGE.—A health insurance issuer offering indi21 vidual health insurance coverage may not enter into 

22 an agreement with a health care provider, network or 

23 association of providers, or other service provider of24 fering access to a network of providers that would diVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00296 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 rectly or indirectly restrict the health insurance issuer 

2 from— 

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

4 quality of care information, through a consumer 

5 engagement tool or any other means, to referring 

6 providers, enrollees, or eligible enrollees of the 

7 plan or coverage; or 

8 ‘‘(B) sharing, for plan design, plan admin9 istration, and plan, financial, legal, and quality 

10 improvement activities, data described in sub11 paragraph (A) with a business associate as de12 fined in section 160.103 of title 45, Code of Fed13 eral Regulations (or successor regulations), con14 sistent with the privacy regulations promulgated 

15 pursuant to section 264(c) of the Health Insur16 ance Portability and Accountability Act, the 

17 amendments to this Act made by the Genetic In18 formation Nondiscrimination Act of 2008, and 

19 the Americans with Disabilities Act of 1990. 

20 ‘‘(3) CLARIFICATION REGARDING PUBLIC DISCLO21 SURE OF INFORMATION.—Nothing in paragraph 

22 (1)(A) or (2)(A) prevents a health care provider, net23 work or association of providers, or other service pro24 vider from placing reasonable restrictions on the pubVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00297 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 lic disclosure of the information described in such 

2 paragraphs (1) and (2). 

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

4 health insurance issuer offering group or individual 

5 health insurance coverage shall annually submit to, 

6 as applicable, the applicable authority described in 

7 section 2723 or the Secretary of Labor, an attestation 

8 that such plan or issuer is in compliance with the re9 quirements of this subsection. 

10 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in this 

11 section shall be construed to otherwise limit group 

12 health plan, plan sponsor, or health insurance issuer 

13 access to data currently permitted under the privacy 

14 regulations promulgated pursuant to section 264(c) of 

15 the Health Insurance Portability and Accountability 

16 Act, the amendments to this Act made by the Genetic 

17 Information Nondiscrimination Act of 2008, and the 

18 Americans with Disabilities Act of 1990.’’. 

19 SEC. 302. BANNING ANTICOMPETITIVE TERMS IN FACILITY 

20 AND INSURANCE CONTRACTS THAT LIMIT AC21 CESS TO HIGHER QUALITY, LOWER COST 

22 CARE. 

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

24 Service Act, as added by section 301, is amended by adding 

25 at the end the following: 


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1 ‘‘(b) PROTECTING HEALTH PLANS NETWORK DESIGN

2 FLEXIBILITY.— 

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

4 health insurance issuer offering group or individual 

5 health insurance coverage shall not enter into an 

6 agreement with a provider, network or association of 

7 providers, or other service provider offering access to 

8 a network of service providers if such agreement, di9 rectly or indirectly— 

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

11 health insurance issuer from— 

12 ‘‘(i) directing or steering enrollees to 

13 other health care providers; or 

14 ‘‘(ii) offering incentives to encourage 

15 enrollees to utilize specific health care pro16 viders; or 

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

18 health insurance issuer to enter into any addi19 tional contract with an affiliate of the provider, 

20 such as an affiliate of the provider, as a condi21 tion of entering into a contract with such pro22 vider; 

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

24 health insurance issuer to agree to payment rates 


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1 or other terms for any affiliate not party to the 

2 contract of the provider involved; or 

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

4 health insurance issuers not party to the contract 

5 from paying a lower rate for items or services 

6 than the contracting plan or issuer pays for such 

7 items or services. 

8 ‘‘(2) ADDITIONAL REQUIREMENT FOR SELF-IN9 SURED PLANS.—A self-insured group health plan 

10 shall not enter into an agreement with a provider, 

11 network or association of providers, third-party ad12 ministrator, or other service provider offering access 

13 to a network of providers if such agreement directly 

14 or indirectly requires the group health plan to certify, 

15 attest, or otherwise confirm in writing that the group 

16 health plan is bound by restrictive contracting terms 

17 between the service provider and a third-party ad18 ministrator that the group health plan is not party 

19 to, without a disclosure that such terms exist. 

20 ‘‘(3) EXCEPTION FOR CERTAIN GROUP MODEL

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

22 group health plan or health insurance issuer offering 

23 group or individual health insurance coverage with 

24 respect to— 


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1 ‘‘(A) a health maintenance organization (as 

2 defined in section 2791(b)(3)), if such health 

3 maintenance organization operates primarily 

4 through exclusive contracts with multi-specialty 

5 physician groups, nor to any arrangement be6 tween such a health maintenance organization 

7 and its affiliates; or 

8 ‘‘(B) a value-based network arrangement, 

9 such as an exclusive provider network, account10 able care organization, center of excellence, a 

11 provider sponsored health insurance issuer that 

12 operates primarily through aligned multi-spe13 cialty physician group practices or integrated 

14 health systems, or such other similar network ar15 rangements as determined by the Secretary 

16 through rulemaking. 

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

18 health insurance issuer offering group or individual 

19 health insurance coverage shall annually submit to, 

20 as applicable, the applicable authority described in 

21 section 2723 or the Secretary of Labor, an attestation 

22 that such plan or issuer is in compliance with the re23 quirements of this subsection. 

24 ‘‘(c) MAINTENANCE OF EXISTING HIPAA, GINA, AND

25 ADA PROTECTIONS.—Nothing in this section shall modify, 


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1 reduce, or eliminate the existing privacy protections and 

2 standards provided by reason of State and Federal law, in3 cluding the requirements of parts 160 and 164 of title 45, 

4 Code of Federal Regulations (or any successor regulations). 

5 ‘‘(d) REGULATIONS.—The Secretary, not later than 1 

6 year after the date of enactment of the Lower Health Care 

7 Costs Act, shall promulgate regulations to carry out this 

8 section. 

9 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec10 tion shall be construed to limit network design or cost or 

11 quality initiatives by a group health plan or health insur12 ance issuer, including accountable care organizations, ex13 clusive provider organizations, networks that tier providers 

14 by cost or quality or steer enrollees to centers of excellence, 

15 or other pay-for-performance programs. 

16 ‘‘(f) CLARIFICATION WITH RESPECT TO ANTITRUST

17 LAWS.—Compliance with this section does not constitute 

18 compliance with the antitrust laws, as defined in subsection 

19 (a) of the first section of the Clayton Act (15 U.S.C. 

20 12(a)).’’. 

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

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

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

24 entered into on or after the date that is 18 months after 

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1 cable contract that is in effect on the date of enactment of 

2 this Act, such section 2729B shall apply on the earlier of 

3 the date of renewal of such contract or 3 years after such 

4 date of enactment. 

5 SEC. 303. DESIGNATION OF A NONGOVERNMENTAL, NON6 PROFIT TRANSPARENCY ORGANIZATION TO 

7 LOWER AMERICANS’ HEALTH CARE COSTS. 

8 (a) IN GENERAL.—Subpart C of title XXVII of the 

9 Public Health Service Act (42 U.S.C. 300gg–91 et seq.), as 

10 amended by section 102, is further amended by adding at 

11 the end the following: 

12 ‘‘SEC. 2796. DESIGNATION OF A NONGOVERNMENTAL, NON13 PROFIT TRANSPARENCY ORGANIZATION TO 

14 LOWER AMERICANS’ HEALTH CARE COSTS. 

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

16 with the Secretary of Labor, not later than 1 year after 

17 the date of enactment of the Lower Health Care Costs Act, 

18 shall enter into a contract with a nonprofit entity to sup19 port the establishment and maintenance of a database that 

20 receives and utilizes health care claims information and re21 lated information and issues reports that are available to 

22 the public and authorized users, and are submitted to the 

23 Department of Health and Human Services. 

24 ‘‘(b) REQUIREMENTS.— 


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

2 under subsection (a) shall— 

3 ‘‘(A) improve transparency by using de4 identified health care data to— 

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

6 quality, and value of their care; 

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

8 they work with patients, to make informed 

9 choices about care; 

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

11 communities to improve services and out12 comes for patients by benchmarking their 

13 performance against that of other providers, 

14 hospitals, and communities; 

15 ‘‘(iv) enable purchasers, including em16 ployers, employee organizations, and health 

17 plans, to develop value-based purchasing 

18 models, improve quality, and reduce the cost 

19 of health care and insurance coverage for 

20 enrollees; 

21 ‘‘(v) enable employers and employee or22 ganizations to evaluate network design and 

23 construction, and the cost of care for enroll24 ees; 


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

2 lower health care costs and improve quality; 

3 and 

4 ‘‘(vii) promote competition based on 

5 quality and cost; 

6 ‘‘(B) collect medical claims, prescription 

7 drug claims, and remittance data consistent with 

8 the protections and requirements of subsection 

9 (d); 

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

11 allows the data collected pursuant to subpara12 graph (B) to be shared with any State all-payer 

13 claims database or regional database operated 

14 with authorization from States, at cost, using a 

15 standardized format, if such State or regional 

16 database also submits claims data to the data17 base established under this section; and 

18 ‘‘(D) be available to— 

19 ‘‘(i) the Director of the Congressional 

20 Budget Office, the Comptroller General of 

21 the United States, the Executive Director of 

22 the Medicare Payment Advisory Commis23 sion, and the Executive Director of the Med24 icaid and CHIP Payment Advisory Com25 mission, upon request, subject to the privacy 


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1 and security requirements of authorized 

2 users under subsection (e)(2); and 

3 ‘‘(ii) authorized users, including em4 ployers, employee organizations, providers, 

5 researchers, and policymakers, subject to 

6 subsection (e). 

7 ‘‘(2) PRIVACY AND SECURITY; BREACH NOTIFICA8 TIONS.— 

9 ‘‘(A) REGULATIONS.— 

10 ‘‘(i) IN GENERAL.—The Secretary shall 

11 issue regulations prescribing the extent to 

12 which, and the manner in which, the fol13 lowing rules (and any successors of such 

14 rules) shall apply to the activities under 

15 this section of an entity receiving a contract 

16 under subsection (a): 

17 ‘‘(I) The Privacy Rule under part 

18 160 and subparts A and E of part 164 

19 of title 45, Code of Federal Regulations 

20 (or any successor regulations). 

21 ‘‘(II) The Security Rule under 

22 part 160 and subparts A and C of part 

23 164 of such title 45 (or any successor 

24 regulations). 


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1 ‘‘(III) The Breach Notification 

2 Rule under part 160 and subparts A 

3 and D of part 164 of such title 45 (or 

4 any successor regulations). 

5 ‘‘(ii) SUPPLEMENTAL REGULATIONS.— 

6 In order to ensure data privacy and secu7 rity and the notification of breaches, the 

8 Secretary may issue such supplemental reg9 ulations on the subjects of the rules listed 

10 under clause (i) as the Secretary determines 

11 appropriate to address differences between 

12 the activities described by this section and 

13 the activities covered by such rules. 

14 ‘‘(B) ENFORCEMENT.—Section 1176 of So15 cial Security Act shall apply with respect to a 

16 violation of this paragraph in the same manner 

17 such section 1176 applies to a violation of part 

18 C of title XI of the Social Security Act, and the 

19 Secretary may include in the regulations pro20 mulgated under this section provisions to apply 

21 such section to this paragraph. 

22 ‘‘(C) PROCEDURE.— 

23 ‘‘(i) TIMING.—The Secretary shall 

24 issue the initial set of regulations under this 

25 paragraph not later than 1 year after the 


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1 date of enactment of the Lower Health Care 

2 Costs Act. 

3 ‘‘(ii) AUTHORITY TO USE INTERIM

4 FINAL PROCEDURES.—The Secretary may 

5 make such initial set of regulations effective 

6 and final immediately upon issuance, on an 

7 interim basis, and provide for a period of 

8 public comment on such initial set of regu9 lations after the date of publication. 

10 ‘‘(D) REQUIREMENTS OF ENTITY.—The en11 tity receiving the contract under this section 

12 shall— 

13 ‘‘(i) not disclose to the public any indi14 vidually identifiable health information or 

15 proprietary financial information; 

16 ‘‘(ii) strictly limit staff access to the 

17 data to staff with appropriate training, 

18 clearance, and background checks and re19 quire regular privacy and security training; 

20 ‘‘(iii) maintain effective security 

21 standards for transferring data or making 

22 data available to authorized users; 

23 ‘‘(iv) develop a process for providing 

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1 cure manner that maintains privacy and 

2 confidentiality of data; and 

3 ‘‘(v) adhere to current best security 

4 practices with respect to the management 

5 and use of such data for health services re6 search, in accordance with applicable Fed7 eral privacy law 

8 ‘‘(3) CONSULTATION.— 

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

10 than 180 days after the date of enactment of the 

11 Lower Health Care Costs Act, the Secretary shall 

12 convene an Advisory Committee (referred to in 

13 this section as the ‘Committee’), consisting of 13 

14 members, to advise the Secretary, the contracting 

15 entity, and Congress on the establishment, oper16 ations, and use of the database established under 

17 this section. 

18 ‘‘(B) MEMBERSHIP.— 

19 ‘‘(i) APPOINTMENT.—In accordance 

20 with clause (ii), the Secretary, in consulta21 tion with the Secretary of Labor and the 

22 Comptroller General of the United States 

23 shall, not later than 180 days after the date 

24 of enactment of the Lower Health Care 

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1 mittee who have distinguished themselves in 

2 the fields of health services research, health 

3 economics, health informatics, or the gov4 ernance of State all-payer claims databases, 

5 or who represent organizations likely to sub6 mit data to or use the database, including 

7 patients, employers, or employee organiza8 tions that sponsor group health plans, 

9 health care providers, health insurance 

10 issuers, or third-party administrators of 

11 group health plans. Such members shall 

12 serve 3-year terms on a staggered basis. Va13 cancies on the Committee shall be filled by 

14 appointment consistent with this subsection 

15 not later than 3 months after the vacancy 

16 arises. 

17 ‘‘(ii) COMPOSITION.—In accordance 

18 with clause (i)— 

19 ‘‘(I) the Secretary, in consultation 

20 with the Secretary of Labor, shall ap21 point to the Committee— 

22 ‘‘(aa) 1 member selected by 

23 the Secretary, in coordination 

24 with the Secretary of Labor, to 


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1 serve as the chair of the Com2 mittee; 

3 ‘‘(bb) the Assistant Secretary 

4 for Planning and Evaluation of 

5 the Department of Health and 

6 Human Services, or a designee of 

7 such Assistant Secretary; 

8 ‘‘(cc) 1 representative of the 

9 Centers for Medicare & Medicaid 

10 Services; 

11 ‘‘(dd) 1 representative of the 

12 Agency for Health Research and 

13 Quality; 

14 ‘‘(ee) 1 representative of the 

15 Office for Civil Rights of the De16 partment of Health and Human 

17 Services with expertise in data 

18 privacy and security; 

19 ‘‘(ff) 1 representative of the 

20 National Center for Health Statis21 tics; and 

22 ‘‘(gg) 1 representative of the 

23 Employee Benefits and Security 

24 Administration of the Department 

25 of Labor; and 


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1 ‘‘(II) the Comptroller General of 

2 the United States shall appoint to the 

3 Committee— 

4 ‘‘(aa) 1 representative of an 

5 employer that sponsors a group 

6 health plan; 

7 ‘‘(bb) 1 representative of an 

8 employee organization that spon9 sors a group health plan; 

10 ‘‘(cc) 1 academic researcher 

11 with expertise in health economics 

12 or health services research; 

13 ‘‘(dd) 1 consumer advocate; 

14 and 

15 ‘‘(ee) 2 additional members. 

16 ‘‘(C) DUTIES.—The Committee shall— 

17 ‘‘(i) advise the Secretary on the man18 agement of the contract under subsection 

19 (a); 

20 ‘‘(ii) assist and advise the entity re21 ceiving the contract under subsection (a) in 

22 establishing— 

23 ‘‘(I) the scope and format of the 

24 data to be submitted under subsection 

25 (d); 


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1 ‘‘(II) best practices with respect to 

2 de-identification of data, as appro3 priate; 

4 ‘‘(III) the appropriate uses of 

5 data by authorized users, including de6 veloping standards for the approval of 

7 requests by organizations to access and 

8 use the data; and 

9 ‘‘(IV) the appropriate formats and 

10 methods for making reports and anal11 yses based on the database to the pub12 lic; 

13 ‘‘(iii) conduct an annual review of 

14 whether data was used according to the ap15 propriate uses as described in clause 

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

17 using the data for authorized purposes; 

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

19 Secretary and Congress on the operation of 

20 the database and opportunities to better 

21 achieve the objectives of this section; 

22 ‘‘(v) establish additional restrictions on 

23 researchers who receive compensation from 

24 entities described in subsection (e)(2)(B)(ii), 


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1 in order to protect proprietary financial in2 formation; and 

3 ‘‘(vi) establish objectives for research 

4 and public reporting. 

5 ‘‘(4) STATE REQUIREMENTS.—A State may re6 quire health insurance issuers and other payers to 

7 submit claims data to the database established under 

8 this section, provided that such data is submitted to 

9 the entity awarded the contract under this section in 

10 a form and manner established by the Secretary, and 

11 pursuant to subsection (d)(4)(B). 

12 ‘‘(5) SANCTIONS.—The Secretary shall take ap13 propriate action to sanction users who attempt to re14 identify data accessed pursuant to paragraph (1)(D). 

15 ‘‘(c) CONTRACT REQUIREMENTS.— 

16 ‘‘(1) COMPETITIVE PROCEDURES.—The Secretary 

17 shall enter into the contract under subsection (a) 

18 using full and open competition procedures pursuant 

19 to chapter 33 of title 41, United States Code. 

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

21 into a contract described in subsection (a), an entity 

22 shall— 

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

24 by a board that includes representatives of the 

25 academic research community and individuals 


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1 with expertise in employer-sponsored insurance, 

2 research using health care claims data and actu3 arial analysis; 

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

5 transparent manner that provides the oppor6 tunity for public comment on its activities; and 

7 ‘‘(C) agree to comply with any requirements 

8 imposed under the rulemaking described in sub9 section (d)(4)(A). 

10 ‘‘(3) CONSIDERATIONS.—In awarding the con11 tract under subsection (a), the Secretary shall con12 sider an entity’s experience in— 

13 ‘‘(A) health care claims data collection, ag14 gregation, quality assurance, analysis, and secu15 rity; 

16 ‘‘(B) supporting academic research on 

17 health costs, spending, and utilization for and by 

18 privately insured patients; 

19 ‘‘(C) working with large health insurance 

20 issuers and third-party administrators to assem21 ble a national claims database; 

22 ‘‘(D) effectively collaborating with and en23 gaging stakeholders to develop reports; 

24 ‘‘(E) meeting budgets and timelines, includ25 ing in connection with report generation; and 


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1 ‘‘(F) facilitating the creation of, or sup2 porting, State all-payer claims databases. 

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

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

5 may be renewed after a subsequent competitive bid6 ding process under this section. 

7 ‘‘(5) TRANSITION OF CONTRACT.—If the Sec8 retary, following a competitive process at the end of 

9 the contract period, selects a new entity to maintain 

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

11 entity according to a schedule and process to be deter12 mined by the Secretary. Upon termination of a con13 tract, no entity may keep data held by the database 

14 or disclose such data to any entity other than the en15 tity so designated by the Secretary. The Secretary 

16 shall include enforcement terms in any contract with 

17 an organization chosen under this section, to ensure 

18 the timely transfer of all data, and any associated 

19 code or algorithms, to a new entity in the event of 

20 contract termination. 

21 ‘‘(d) RECEIVING HEALTH INFORMATION.— 

22 ‘‘(1) REQUIREMENTS.— 

23 ‘‘(A) IN GENERAL.—The Secretary of Labor 

24 shall ensure that the applicable self-insured 

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1 ministrator, pharmacy benefit manager, or other 

2 entity designated by the group health plan, as 

3 applicable, electronically submits all claims data 

4 with respect to the plan, pursuant to subpara5 graph (B). 

6 ‘‘(B) SCOPE OF INFORMATION AND FORMAT

7 OF SUBMISSION.—The entity awarded the con8 tract under subsection (a), in consultation with 

9 the Committee described in subsection (b)(3), and 

10 pursuant to the privacy and security require11 ments of subsection (b)(2), shall— 

12 ‘‘(i) specify the data elements required 

13 to be submitted under subparagraph (A), 

14 which shall include all data related to 

15 transactions described in subparagraphs (A) 

16 and (E) of section 1173(a)(2) of the Social 

17 Security Act, including all data elements 

18 normally present in such transactions when 

19 adjudicated, and enrollment information; 

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

21 such submissions, and the historical period 

22 to be included in the initial submission; 

23 and 


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1 ‘‘(iii) offer an automated submission 

2 option to minimize administrative burdens 

3 for entities required to submit data. 

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

5 entity awarded the contract under subsection (a) 

6 shall— 

7 ‘‘(i) establish a process under which 

8 data is de-identified consistent with the de9 identification requirements under section 

10 164.514 of title 45, Code of Federal Regula11 tions (or any successor regulations), while 

12 retaining the ability to link data longitu13 dinally for the purposes of research on cost 

14 and quality, and the ability to complete 

15 risk adjustment and geographic analysis; 

16 ‘‘(ii) ensure that any third-party sub17 contractors who perform the de-identifica18 tion process described in clause (i) retain 

19 only the minimum necessary information to 

20 perform such a process, and adhere to effec21 tive security and encryption practices in 

22 data storage and transmission; 

23 ‘‘(iii) store claims and other data col24 lected under this subsection only in de-iden25 tified form, in accordance with section 


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1 164.514 of title 45, Code of Federal Regula2 tions (or any successor regulations); and 

3 ‘‘(iv) ensure that individually identifi4 able data is encrypted, in accordance with 

5 guidance issued by the Secretary under sec6 tion 13402(h)(2) of the HITECH Act. 

7 ‘‘(2) APPLICABLE SELF-INSURED GROUP HEALTH

8 PLAN.—For purposes of paragraph (1), a self-insured 

9 group health plan is an applicable self-insured group 

10 health plan if such plan is self-administered, or is ad11 ministered by a third-party plan administrator that 

12 meets 1 or both of the following criteria: 

13 ‘‘(A) Administers health, medical, or phar14 macy benefits for more than 50,000 enrollees. 

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

16 or issuers of self-insured group health plans in a 

17 State in which such administrator operates, as 

18 measured by the aggregate number of enrollees in 

19 plans administered by such administrator in 

20 such State, as determined by the Secretary. 

21 ‘‘(3) THIRD-PARTY ADMINISTRATORS.—In the 

22 case of a third-party administrator that is required 

23 under this subsection to submit claims data with re24 spect to an applicable self-insured group health plan, 

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1 spect to all self-insured group health plans that the 

2 administrator administers, including such plans that 

3 are not applicable self-insured group health plans, as 

4 described in paragraph (2). 

5 ‘‘(4) RECEIVING OTHER INFORMATION.— 

6 ‘‘(A) MEDICARE DATA.—The Secretary, 

7 through rulemaking, shall ensure that the data 

8 made available to such entity is available to 

9 qualified entities under section 1874(e) of the So10 cial Security Act is made available to the entity 

11 awarded a contract under subsection (a). 

12 ‘‘(B) STATE DATA.—The entity awarded the 

13 contract under subsection (a) shall collect data 

14 from State all payer claims databases that seek 

15 access to the database established under this sec16 tion. 

17 ‘‘(5) AVAILABILITY OF DATA.—An entity re18 quired to submit data under this subsection may not 

19 place any restrictions on the use of such data by au20 thorized users. 

21 ‘‘(e) USES OF INFORMATION.— 

22 ‘‘(1) IN GENERAL.—The entity awarded the con23 tract under subsection (a) shall make the database 

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1 section, at cost, and reports and analyses based on the 

2 data available to the public with no charge. 

3 ‘‘(2) AUTHORIZATION OF USERS.— 

4 ‘‘(A) IN GENERAL.—An entity may request 

5 authorization by the entity awarded the contract 

6 under subsection (a) for access to the database in 

7 accordance with this paragraph. 

8 ‘‘(B) APPLICATION.—An entity desiring au9 thorization under this paragraph shall submit to 

10 the entity awarded the contract an application 

11 for such access, which shall include— 

12 ‘‘(i) in the case of an entity requesting 

13 access for research purposes— 

14 ‘‘(I) a description of the uses and 

15 methodologies for evaluating health 

16 system performance using such data; 

17 and 

18 ‘‘(II) documentation of approval 

19 of the research by an institutional re20 view board, if applicable for a par21 ticular plan of research; or 

22 ‘‘(ii) in the case of an entity such as 

23 an employer, health insurance issuer, third24 party administrator, or health care pro25 vider, requesting access for the purpose of 


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1 quality improvement or cost-containment, a 

2 description of the intended uses for such 

3 data. 

4 ‘‘(C) REQUIREMENTS.— 

5 ‘‘(i) RESEARCH.—Upon approval of an 

6 application for research purposes under 

7 subparagraph (B)(i), the authorized user 

8 shall enter into a data use and confiden9 tiality agreement with the entity awarded 

10 the contract under subsection (a), which 

11 shall include a prohibition on attempts to 

12 reidentify and disclose individually identifi13 able health information and proprietary fi14 nancial information. 

15 ‘‘(ii) QUALITY IMPROVEMENT AND

16 COST-CONTAINMENT.—In consultation with 

17 the Committee described in subsection 

18 (b)(3), the Secretary shall, through rule19 making, establish the form and manner in 

20 which authorized users described in sub21 paragraph (B)(ii) may access data. Data 

22 provided to such authorized users shall be 

23 provided in a form and manner such that 

24 users may not obtain individually identifi25 able price information with respect to direct 


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1 competitors. Upon approval, such author2 ized user shall enter into a data use and 

3 confidentiality agreement with the entity. 

4 ‘‘(iii) CUSTOMIZED REPORTS.—Em5 ployers and employer organizations may re6 quest customized reports from the entity 

7 awarded the contract under subsection (a), 

8 at cost, subject to the requirements of this 

9 section with respect to privacy, security, 

10 and proprietary financial information. 

11 ‘‘(iv) NON-CUSTOMIZED REPORTS.— 

12 The entity awarded the contract under sub13 section (a), in consultation with the Com14 mittee, shall make available to all author15 ized users aggregate data sets, free of charge. 

16 ‘‘(f) FUNDING.— 

17 ‘‘(1) INITIAL FUNDING.—There are authorized to 

18 be appropriated, and there are appropriated, out of 

19 monies in the Treasury not otherwise appropriated, 

20 $20,000,000 for fiscal year 2020, for the implementa21 tion of the initial contract and establishment of the 

22 database under this section. 

23 ‘‘(2) ONGOING FUNDING.—There are authorized 

24 to be appropriated $15,000,000 for each of fiscal 

25 years 2021 through 2025, for purposes of carrying out 


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1 this section (other than the grant program under sub2 section (h)). 

3 ‘‘(g) ANNUAL REPORT.— 

4 ‘‘(1) SUBMISSION.—On each of the dates de5 scribed in paragraph (2), the entity receiving the con6 tract under subsection (a) shall submit to Congress, 

7 the Secretary of Health and Human Services, and the 

8 Secretary of Labor and publish online for access by 

9 the general public, a report containing a description 

10 of— 

11 ‘‘(A) trends in the price, utilization, and 

12 total spending on health care services, including 

13 a geographic analysis of differences in such 

14 trends; 

15 ‘‘(B) limitations in the data set; 

16 ‘‘(C) progress towards the objectives of this 

17 section; and 

18 ‘‘(D) the performance by the entity of the 

19 duties required under such contract. 

20 ‘‘(2) DATES DESCRIBED.—The reports described 

21 in paragraph (1) shall be submitted— 

22 ‘‘(A) not later than 3 years after the date 

23 of enactment of the Lower Health Care Costs Act; 

24 ‘‘(B) the later of 1 year after the date that 

25 is 3 years after such date of enactment or March 


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1 1 of the year after the date that is 3 years after 

2 such date of enactment; and 

3 ‘‘(C) March 1 of each year thereafter. 

4 ‘‘(3) PUBLIC REPORTS AND RESEARCH.—The en5 tity receiving a contract under subsection (a) shall, in 

6 coordination with authorized users, make analyses 

7 and research available to the public on an ongoing 

8 basis to promote the objectives of this section. 

9 ‘‘(h) GRANTS TO STATES.— 

10 ‘‘(1) IN GENERAL.—The Secretary, in consulta11 tion with the Secretary of Labor, may award grants 

12 to States for the purpose of establishing and main13 taining State all-payer claims databases that improve 

14 transparency of data in order to meet the goals of 

15 subsection (a)(1). 

16 ‘‘(2) REQUIREMENT.—To be eligible to receive 

17 the funding under paragraph (1), a State shall sub18 mit data to the database as described in subsection 

19 (b)(1)(C), using the format described in subsection 

20 (d)(1). 

21 ‘‘(3) FUNDING.—There is authorized to be appro22 priated $100,000,000 for the period of fiscal years 

23 2020 through 2029 for the purpose of awarding 

24 grants to States under this subsection. 

25 ‘‘(i) EXEMPTION FROM PUBLIC DISCLOSURE.— 


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1 ‘‘(1) IN GENERAL.—Claims data provided to the 

2 database, and the database itself shall not be consid3 ered public records and shall be exempt from public 

4 disclosure requirements. 

5 ‘‘(2) RESTRICTIONS ON USES FOR CERTAIN PRO6 CEEDINGS.—Data disclosed to authorized users shall 

7 not be subject to discovery or admission as public in8 formation, or evidence in judicial or administrative 

9 proceedings without consent of the affected parties. 

10 ‘‘(j) DEFINITIONS.— 

11 ‘‘(1) INDIVIDUALLY IDENTIFIABLE HEALTH IN12 FORMATION.—The term ‘individually identifiable 

13 health information’ has the meaning given such term 

14 in section 1171(6) of the Social Security Act. 

15 ‘‘(2) PROPRIETARY FINANCIAL INFORMATION.— 

16 The term ‘proprietary financial information’ means 

17 data that would disclose the terms of a specific con18 tract between an individual health care provider or 

19 facility and a specific group health plan, Medicaid 

20 managed care organization or other managed care en21 tity, or health insurance issuer offering group or indi22 vidual coverage. 

23 ‘‘(k) RULE OF CONSTRUCTION.—Nothing in this sec24 tion shall be construed to affect or modify enforcement of 

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1 gated under section 264(c) of the Health Insurance Port2 ability and Accountability Act of 1996 (or successor regula3 tions).’’. 

4 (b) GAO REPORT.— 

5 (1) IN GENERAL.—The Comptroller General of 

6 the United States shall conduct a study on— 

7 (A) the performance of the entity awarded 

8 a contract under section 2795(a) of the Public 

9 Health Service Act, as added by subsection (a), 

10 under such contract; 

11 (B) the privacy and security of the informa12 tion reported to the entity; and 

13 (C) the costs incurred by such entity in per14 forming such duties. 

15 (2) REPORTS.—Not later than 2 years after the 

16 effective date of the first contract entered into under 

17 section 2795(a) of the Public Health Service Act, as 

18 added by subsection (a), and again not later than 4 

19 years after such effective date, the Comptroller Gen20 eral of the United States shall submit to Congress a 

21 report containing the results of the study conducted 

22 under paragraph (1), together with recommendations 

23 for such legislation and administrative action as the 

24 Comptroller General determines appropriate. 


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1 SEC. 304. PROTECTING PATIENTS AND IMPROVING THE AC2 CURACY OF PROVIDER DIRECTORY INFORMA3 TION. 

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

5 of the Public Health Service Act (42 U.S.C. 300gg–11 et 

6 seq.), as amended by sections 301 and 302, is further 

7 amended by adding at the end the following: 

8 ‘‘SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE 

9 ACCURACY OF PROVIDER DIRECTORY INFOR10 MATION. 

11 ‘‘(a) NETWORK STATUS OF PROVIDERS.— 

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

13 is one year after the date of enactment of this section, 

14 a group health plan or a health insurance issuer of15 fering group or individual health insurance coverage 

16 shall— 

17 ‘‘(A) establish business processes to ensure 

18 that all enrollees in such plan or coverage receive 

19 proof of a health care provider’s network status, 

20 based on what a plan or issuer knows or could 

21 reasonably know— 

22 ‘‘(i) through a written electronic com23 munication from the plan or issuer to the 

24 enrollee, as soon as practicable and not 

25 later than 1 business day after a telephone 


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1 inquiry is made by such enrollee for such 

2 information; 

3 ‘‘(ii) through an oral confirmation, 

4 documented by such issuer or coverage, and 

5 kept in the enrollee’s file for a minimum of 

6 2 years; and 

7 ‘‘(iii) in real-time through an online 

8 health care provider directory search tool 

9 maintained by the plan or issuer; and 

10 ‘‘(B) include in any print directory a dis11 closure that the information included in the di12 rectory is accurate as of the date of the last data 

13 update and that enrollees or prospective enrollees 

14 should consult the group health plan or issuer’s 

15 electronic provider directory on its website or 

16 call a specified customer service telephone num17 ber to obtain the most current provider directory 

18 information. 

19 ‘‘(2) GROUP HEALTH PLAN AND HEALTH INSUR20 ANCE ISSUER BUSINESS PROCESSES.—Beginning on 

21 the date that is one year after the date of enactment 

22 of the Lower Health Care Costs Act, a group health 

23 plan or a health insurance issuer offering group or 

24 individual health insurance coverage shall establish 

25 business processes to— 


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1 ‘‘(A) verify and update, at least once every 

2 90 days, the provider directory information for 

3 all providers included in the online health care 

4 provider directory search tool described in para5 graph (1)(A)(iii); and 

6 ‘‘(B) remove any provider from such online 

7 directory search tool if such provider has not 

8 verified the directory information within the pre9 vious 6 months or the plan or issuer has been 

10 unable to verify the provider’s network partici11 pation. 

12 ‘‘(b) COST-SHARING LIMITATIONS.— 

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

14 health insurance issuer offering group or individual 

15 health insurance coverage shall not apply, and shall 

16 ensure that no provider applies cost-sharing to an en17 rollee for treatment or services provided by a health 

18 care provider in excess of the normal cost-sharing ap19 plied for in-network care (including any balance bill 

20 issued by the health care provider involved), if such 

21 enrollee, or health care provider referring such en22 rollee, demonstrates (based on the electronic, written 

23 information described in subsection (a)(1)(A)(i), the 

24 oral confirmation described in subsection 

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1 tory described in subsection (a)(1)(A)(iii) on the date 

2 the enrollee attempted to obtain the provider’s net3 work status) that the enrollee relied on the informa4 tion described in subsection (a)(1), if the provider’s 

5 network status or directory information on such di6 rectory was incorrect at the time the treatment or 

7 services involved was provided. 

8 ‘‘(2) REFUNDS TO ENROLLEES.—If a health care 

9 provider submits a bill to an enrollee in violation of 

10 paragraph (1), and the enrollee pays such bill, the 

11 provider shall reimburse the enrollee for the full 

12 amount paid by the enrollee in excess of the in-net13 work cost-sharing amount for the treatment or serv14 ices involved, plus interest, at an interest rate deter15 mined by the Secretary. 

16 ‘‘(c) PROVIDER BUSINESS PROCESSES.—A health care 

17 provider shall have in place business processes to ensure the 

18 timely provision of provider directory information to a 

19 group health plan or a health insurance issuer offering 

20 group or individual health insurance coverage to support 

21 compliance by such plans or issuers with subsection (a)(1). 

22 Such providers shall submit provider directory information 

23 to a plan or issuers, at a minimum— 


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1 ‘‘(1) when the provider begins a network agree2 ment with a plan or with an issuer with respect to 

3 certain coverage; 

4 ‘‘(2) when the provider terminates a network 

5 agreement with a plan or with an issuer with respect 

6 to certain coverage; 

7 ‘‘(3) when there are material changes to the con8 tent of provider directory information described in 

9 subsection (a)(1); and 

10 ‘‘(4) every 90 days throughout the duration of 

11 the network agreement with a plan or issuer. 

12 ‘‘(d) ENFORCEMENT.— 

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

14 health care provider that violates a requirement under 

15 subsection (c) or takes actions that prevent a group 

16 health plan or health insurance issuer from com17 plying with subsection (a)(1) or (b) shall be subject to 

18 a civil monetary penalty of not more than $10,000 

19 for each act constituting such violation. 

20 ‘‘(2) SAFE HARBOR.—The Secretary may waive 

21 the penalty described under paragraph (1) with re22 spect to a health care provider that unknowingly vio23 lates subsection (b)(1) with respect to an enrollee if 

24 such provider rescinds the bill involved and, if appli25 cable, reimburses the enrollee within 30 days of the 


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1 date on which the provider billed the enrollee in viola2 tion of such subsection. 

3 ‘‘(3) PROCEDURE.—The provisions of section 

4 1128A of the Social Security Act, other than sub5 sections (a) and (b) and the first sentence of sub6 section (c)(1) of such section, shall apply to civil 

7 money penalties under this subsection in the same 

8 manner as such provisions apply to a penalty or pro9 ceeding under section 1128A of the Social Security 

10 Act. 

11 ‘‘(e) SAVINGS CLAUSE.—Nothing in this section shall 

12 prohibit a provider from requiring in the terms of a con13 tract, or contract termination, with a group health plan 

14 or health insurance issuer— 

15 ‘‘(1) that the plan or issuer remove, at the time 

16 of termination of such contract, the provider from a 

17 directory of the plan or issuer described in subsection 

18 (a)(1); or 

19 ‘‘(2) that the plan or issuer bear financial re20 sponsibility, including under subsection (b), for pro21 viding inaccurate network status information to an 

22 enrollee. 

23 ‘‘(f) DEFINITION.—For purposes of this section, the 

24 term ‘provider directory information’ includes the names, 

25 addresses, specialty, and telephone numbers of individual 


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1 health care providers, and the names, addresses, and tele2 phone numbers of each medical group, clinic, or facility 

3 contracted to participate in any of the networks of the 

4 group health plan or health insurance coverage involved. 

5 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec6 tion shall be construed to preempt any provision of State 

7 law relating to health care provider directories or network 

8 adequacy.’’. 

9 (b) EFFECTIVE DATE.—Section 2729C of the Public 

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

11 effect with respect to plan years beginning on or after the 

12 date that is 18 months after the date of enactment of this 

13 Act. 

14 SEC. 305. TIMELY BILLS FOR PATIENTS. 

15 (a) IN GENERAL.— 

16 (1) AMENDMENT.—Part P of title III of the Pub17 lic Health Service Act (42 U.S.C. 280g et seq.) is 

18 amended by adding at the end the following: 

19 ‘‘SEC. 399V–7. TIMELY BILLS FOR PATIENTS. 

20 ‘‘(a) IN GENERAL.—The Secretary shall require— 

21 ‘‘(1) health care facilities, or in the case of prac22 titioners providing services outside of such a facility, 

23 practitioners, to provide to patients a list of services 

24 rendered during the visit to such facility or practi25 tioner, and, in the case of a facility, the name of the 


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1 provider for each such service, upon discharge or end 

2 of the visit or by postal or electronic communication 

3 as soon as practicable and not later than 5 calendar 

4 days after discharge or date of visit; and 

5 ‘‘(2) health care facilities and practitioners to 

6 furnish all adjudicated bills to the patient as soon as 

7 practicable, but not later than 45 calendar days after 

8 discharge or date of visit. 

9 ‘‘(b) PAYMENT AFTER BILLING.—No patient may be 

10 required to pay a bill for health care services any earlier 

11 than 35 days after the postmark date of a bill for such serv12 ices. 

13 ‘‘(c) EFFECT OF VIOLATION.— 

14 ‘‘(1) NOTIFICATION AND REFUND REQUIRE15 MENTS.— 

16 ‘‘(A) PROVIDER LISTS.—If a facility or 

17 practitioner fails to provide a patient a list as 

18 required under subsection (a)(1), such facility or 

19 practitioner shall report such failure to the Sec20 retary. 

21 ‘‘(B) BILLING.—If a facility or practitioner 

22 bills a patient after the 45-calendar-day period 

23 described in subsection (a)(2), such facility or 

24 practitioner shall— 


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1 ‘‘(i) report such bill to the Secretary; 

2 and 

3 ‘‘(ii) refund the patient for the full 

4 amount paid in response to such bill with 

5 interest, at a rate determined by the Sec6 retary. 

7 ‘‘(2) CIVIL MONETARY PENALTIES.— 

8 ‘‘(A) IN GENERAL.—The Secretary may im9 pose civil monetary penalties of up to $10,000 a 

10 day on any facility or practitioner that— 

11 ‘‘(i) fails to provide a list required 

12 under subsection (a)(1) more than 10 times, 

13 beginning on the date of such tenth failure; 

14 ‘‘(ii) submits more than 10 bills out15 side of the period described in subsection 

16 (a)(2), beginning on the date on which such 

17 facility or practitioner sends the tenth such 

18 bill; 

19 ‘‘(iii) fails to report to the Secretary 

20 any failure to provide lists as required 

21 under paragraph (1)(A), beginning on the 

22 date that is 45 calendar days after dis23 charge or visit; or 

24 ‘‘(iv) fails to send any bill as required 

25 under subsection (a)(2), beginning on the 


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1 date that is 45 calendar days after the date 

2 of discharge or visit, as applicable. 

3 ‘‘(B) PROCEDURE.—The provisions of sec4 tion 1128A of the Social Security Act, other than 

5 subsections (a) and (b) and the first sentence of 

6 subsection (c)(1) of such section, shall apply to 

7 civil money penalties under this subsection in 

8 the same manner as such provisions apply to a 

9 penalty or proceeding under section 1128A of the 

10 Social Security Act. 

11 ‘‘(3) SAFE HARBOR.—The Secretary may exempt 

12 a practitioner or facility from the penalties under 

13 paragraph (2)(A) or extend the period of time speci14 fied under subsection (a)(2) for compliance with such 

15 subsection if a practitioner or facility— 

16 ‘‘(A) makes a good-faith attempt to send a 

17 bill within 30 days but is unable to do so be18 cause of an incorrect address; or 

19 ‘‘(B) experiences extenuating circumstances 

20 (as defined by the Secretary), such as a hurri21 cane or cyberattack, that may reasonably delay 

22 delivery of a timely bill.’’. 

23 (2) RULEMAKING.—Not later than 1 year after 

24 the date of enactment of this Act, the Secretary shall 

25 promulgate final regulations to define the term ‘‘exVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00337 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 tenuating circumstance’’ for purposes of section 

2 399V–7(c)(3)(B) of the Public Health Service Act, as 

3 added by paragraph (1). 

4 (b) GROUP HEALTH PLAN AND HEALTH INSURANCE

5 ISSUER REQUIREMENTS.—Subpart II of part A of title 

6 XXVII of the Public Health Service Act (42 U.S.C. 300gg– 

7 11), as amended by section 304, is further amended by add8 ing at the end the following: 

9 ‘‘SEC. 2729D. TIMELY BILLS FOR PATIENTS. 

10 ‘‘(a) IN GENERAL.—A group health plan or health in11 surance issuer offering group or individual health insur12 ance coverage shall have in place business practices with 

13 respect to in-network facilities and practitioners to ensure 

14 that claims are adjudicated in order to facilitate facility 

15 and practitioner compliance with the requirements under 

16 section 399V–7(a). 

17 ‘‘(b) CLARIFICATION.—Nothing in subsection (a) pro18 hibits a provider and a group health plan or health insur19 ance issuer from establishing in a contract the timeline for 

20 submission by either party to the other party of billing in21 formation, adjudication, sending of remittance information, 

22 or any other coordination required between the provider 

23 and the plan or issuer necessary for meeting the deadline 

24 described in section 399V–7(a)(2).’’. 


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1 (c) EFFECTIVE DATE.—The amendments made by sub2 sections (a) and (b) shall take effect 6 months after the date 

3 of enactment of this Act. 

4 SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BEN5 EFIT MANAGER SERVICES. 

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

7 Health Service Act (42 U.S.C. 300gg–11 et seq.), as amend8 ed by section 305(b), is further amended by adding at the 

9 end the following: 

10 ‘‘SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BEN11 EFIT MANAGER SERVICES. 

12 ‘‘(a) IN GENERAL.—A group health plan or health in13 surance issuer offering group health insurance coverage or 

14 an entity or subsidiary providing pharmacy benefits man15 agement services shall not enter into a contract with a drug 

16 manufacturer, distributor, wholesaler, subcontractor, rebate 

17 aggregator, or any associated third party that limits the 

18 disclosure of information to plan sponsors in such a manner 

19 that prevents the plan or coverage, or an entity or sub20 sidiary providing pharmacy benefits management services 

21 on behalf of a plan or coverage from making the reports 

22 described in subsection (b). 

23 ‘‘(b) REPORTS TO GROUP PLAN SPONSORS.— 

24 ‘‘(1) IN GENERAL.—Beginning with the first 

25 plan year that begins after the date of enactment of 


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1 the Lower Health Care Costs Act, not less frequently 

2 than once every 6 months, a health insurance issuer 

3 offering group health insurance coverage or an entity 

4 providing pharmacy benefits management services on 

5 behalf of a group health plan shall submit to the plan 

6 sponsor (as defined in section 3(16)(B) of the Em7 ployee Retirement Income Security Act of 1974) of 

8 such group health plan or health insurance coverage 

9 a report in accordance with this subsection and make 

10 such report available to the plan sponsor in a ma11 chine-readable format. Each such report shall include, 

12 with respect to the applicable group health plan or 

13 health insurance coverage— 

14 ‘‘(A) information collected from drug manu15 facturers by such issuer or entity on the total 

16 amount of copayment assistance dollars paid, or 

17 copayment cards applied, that were funded by 

18 the drug manufacturer with respect to the enroll19 ees in such plan or coverage; 

20 ‘‘(B) a list of each covered drug dispensed 

21 during the reporting period, including, with re22 spect to each such drug during the reporting pe23 riod— 

24 ‘‘(i) the brand name, chemical entity, 

25 and National Drug Code; 


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1 ‘‘(ii) the number of enrollees for whom 

2 the drug was filled during the plan year, 

3 the total number of prescription fills for the 

4 drug (including original prescriptions and 

5 refills), and the total number of dosage 

6 units of the drug dispensed across the plan 

7 year, including whether the dispensing 

8 channel was by retail, mail order, or spe9 cialty pharmacy; 

10 ‘‘(iii) the wholesale acquisition cost, 

11 listed as cost per days supply and cost per 

12 pill, or in the case of a drug in another 

13 form, per dose; 

14 ‘‘(iv) the total out-of-pocket spending 

15 by enrollees on such drug, including enrollee 

16 spending through copayments, coinsurance, 

17 and deductibles; 

18 ‘‘(v) for any drug for which gross 

19 spending of the group health plan or health 

20 insurance coverage exceeded $10,000 during 

21 the reporting period— 

22 ‘‘(I) a list of all other available 

23 drugs in the same therapeutic category 

24 or class, including brand name drugs 

25 and biological products and generic 


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1 drugs or biosimilar biological products 

2 that are in the same therapeutic cat3 egory or class; and 

4 ‘‘(II) the rationale for preferred 

5 formulary placement of a particular 

6 drug or drugs in that therapeutic cat7 egory or class; 

8 ‘‘(C) a list of each therapeutic category or 

9 class of drugs that were dispensed under the 

10 health plan or health insurance coverage during 

11 the reporting period, and, with respect to each 

12 such therapeutic category or class of drugs, dur13 ing the reporting period— 

14 ‘‘(i) total gross spending by the plan, 

15 before manufacturer rebates, fees, or other 

16 manufacturer remuneration; 

17 ‘‘(ii) the number of enrollees who filled 

18 a prescription for a drug in that category 

19 or class; 

20 ‘‘(iii) if applicable to that category or 

21 class, a description of the formulary tiers 

22 and utilization mechanisms (such as prior 

23 authorization or step therapy) employed for 

24 drugs in that category or class; 


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1 ‘‘(iv) the total out-of-pocket spending 

2 by enrollees, including enrollee spending 

3 through copayments, coinsurance, and 

4 deductibles; and 

5 ‘‘(v) for each therapeutic category or 

6 class under which 3 or more drugs are in7 cluded on the formulary of such plan or cov8 erage— 

9 ‘‘(I) the amount received, or ex10 pected to be received, from drug manu11 facturers in rebates, fees, alternative 

12 discounts, or other remuneration— 

13 ‘‘(aa) to be paid by drug 

14 manufacturers for claims incurred 

15 during the reporting period; or 

16 ‘‘(bb) that is related to utili17 zation of drugs, in such thera18 peutic category or class; 

19 ‘‘(II) the total net spending, after 

20 deducting rebates, price concessions, al21 ternative discounts or other remunera22 tion from drug manufacturers, by the 

23 health plan or health insurance cov24 erage on that category or class of 

25 drugs; and 


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1 ‘‘(III) the net price per course of 

2 treatment or 30-day supply incurred 

3 by the health plan or health insurance 

4 coverage and its enrollees, after manu5 facturer rebates, fees, and other remu6 neration for drugs dispensed within 

7 such therapeutic category or class dur8 ing the reporting period; 

9 ‘‘(D) total gross spending on prescription 

10 drugs by the plan or coverage during the report11 ing period, before rebates and other manufac12 turer fees or remuneration; 

13 ‘‘(E) total amount received, or expected to 

14 be received, by the health plan or health insur15 ance coverage in drug manufacturer rebates, fees, 

16 alternative discounts, and all other remuneration 

17 received from the manufacturer or any third 

18 party, other than the plan sponsor, related to 

19 utilization of drug or drug spending under that 

20 health plan or health insurance coverage during 

21 the reporting period; 

22 ‘‘(F) the total net spending on prescription 

23 drugs by the health plan or health insurance cov24 erage during the reporting period; and 


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1 ‘‘(G) amounts paid directly or indirectly in 

2 rebates, fees, or any other type of remuneration 

3 to brokers, consultants, advisors, or any other in4 dividual or firm who referred the group health 

5 plan’s or health insurance issuer’s business to the 

6 pharmacy benefit manager. 

7 ‘‘(2) PRIVACY REQUIREMENTS.—Health insur8 ance issuers offering group health insurance coverage 

9 and entities providing pharmacy benefits manage10 ment services on behalf of a group health plan shall 

11 provide information under paragraph (1) in a man12 ner consistent with the privacy, security, and breach 

13 notification regulations promulgated under section 

14 264(c) of the Health Insurance Portability and Ac15 countability Act of 1996 (or successor regulations), 

16 and shall restrict the use and disclosure of such infor17 mation according to such privacy regulations. 

18 ‘‘(3) DISCLOSURE AND REDISCLOSURE.— 

19 ‘‘(A) LIMITATION TO BUSINESS ASSOCI20 ATES.—A group health plan receiving a report 

21 under paragraph (1) may disclose such informa22 tion only to business associates of such plan as 

23 defined in section 160.103 of title 45, Code of 

24 Federal Regulations (or successor regulations). 


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1 ‘‘(B) CLARIFICATION REGARDING PUBLIC

2 DISCLOSURE OF INFORMATION.—Nothing in this 

3 section prevents a health insurance issuer offer4 ing group health insurance coverage or an entity 

5 providing pharmacy benefits management serv6 ices on behalf of a group health plan from plac7 ing reasonable restrictions on the public disclo8 sure of the information contained in a report de9 scribed in paragraph (1), except that such issuer 

10 or entity may not restrict disclosure of such re11 port to governmental agencies pursuant to an in12 vestigation or enforcement action. 

13 ‘‘(C) LIMITED FORM OF REPORT.—The Sec14 retary shall define through rulemaking a limited 

15 form of the report under paragraph (1) required 

16 of plan sponsors who are drug manufacturers, 

17 drug wholesalers, or other direct participants in 

18 the drug supply chain, in order to prevent anti19 competitive behavior. 

20 ‘‘(c) LIMITATIONS ON SPREAD PRICING.— 

21 ‘‘(1) PRESCRIPTION DRUG TRANSACTIONS WITH

22 PHARMACIES INDEPENDENT OF THE ISSUER OR

23 PHARMACY BENEFITS MANAGER.—If the pharmacy 

24 that dispenses a prescription drug to an enrollee in 

25 a group health plan or group or individual health inVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00346 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 surance coverage is not wholly or partially-owned by 

2 such plan, such issuer, or an entity providing phar3 macy benefit management services under such plan or 

4 coverage, such plan, issuer, or entity shall not charge 

5 the plan, issuer, or enrollee a price for such prescrip6 tion drug that exceeds the price paid to the phar7 macy, excluding penalties paid by pharmacies to such 

8 plan, issuer, or entity. 

9 ‘‘(2) INTRA-COMPANY PRESCRIPTION DRUG

10 TRANSACTIONS.—If the mail order, specialty, or retail 

11 pharmacy that dispenses a prescription drug to an 

12 enrollee in a group health plan or health insurance 

13 coverage is wholly or partially owned by, and submits 

14 claims to, such health insurance issuer or an entity 

15 providing pharmacy benefit management services 

16 under a group health plan or group or individual 

17 health insurance coverage, the price charged for such 

18 drug by such pharmacy to such group health plan or 

19 health insurance issuer offering group or individual 

20 health insurance coverage may not exceed the lesser 

21 of— 

22 ‘‘(A) the amount paid to the pharmacy for 

23 acquisition of the drug; or 

24 ‘‘(B) the median price charged to the group 

25 health plan or health insurance issuer when the 


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1 same drug is dispensed to enrollees in the plan 

2 or coverage by other similarly-situated phar3 macies not wholly or partially owned by the 

4 health insurance issuer or entity providing phar5 macy benefits management services, as described 

6 in paragraph (1). 

7 ‘‘(3) SUPPLEMENTARY REPORTING FOR INTRA8 COMPANY PRESCRIPTION DRUG TRANSACTIONS.—A 

9 health insurance issuer of group health insurance cov10 erage or an entity providing pharmacy benefits man11 agement services under a group health plan or group 

12 health insurance coverage that conducts transactions 

13 with a wholly or partially-owned pharmacy, as de14 scribed in paragraph (2), shall submit, together with 

15 the report under subsection (b), a supplementary re16 port every 6 months to the plan sponsor that in17 cludes— 

18 ‘‘(A) an explanation of any benefit design 

19 parameters that encourage enrollees in the plan 

20 or coverage to fill prescriptions at mail order, 

21 specialty, or retail pharmacies that are wholly or 

22 partially-owned by that issuer or entity; 

23 ‘‘(B) the percentage of total prescriptions 

24 charged to the plan, coverage, or enrollees in the 

25 plan or coverage, that were dispensed by mail 


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1 order, specialty, or retail pharmacies that are 

2 wholly or partially-owned by the issuer or entity 

3 providing pharmacy benefits management serv4 ices; and 

5 ‘‘(C) a list of all drugs dispensed by such 

6 wholly or partially-owned pharmacy and 

7 charged to the plan or coverage, or enrollees of 

8 the plan or coverage, during the applicable quar9 ter, and, with respect to each drug— 

10 ‘‘(i) the amount charged per course of 

11 treatment or 30-day supply with respect to 

12 enrollees in the plan or coverage, including 

13 amounts charged to the plan or coverage 

14 and amounts charged to the enrollee; 

15 ‘‘(ii) the median amount charged to the 

16 plan or coverage, per course of treatment or 

17 30-day supply, including amounts paid by 

18 the enrollee, when the same drug is dis19 pensed by other pharmacies that are not 

20 wholly or partially-owned by the issuer or 

21 entity and that are included in the phar22 macy network of that plan or coverage; 

23 ‘‘(iii) the interquartile range of the 

24 costs, per course of treatment or 30-day sup25 ply, including amounts paid by the enrollee, 


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1 when the same drug is dispensed by other 

2 pharmacies that are not wholly or par3 tially-owned by the issuer or entity and 

4 that are included in the pharmacy network 

5 of that plan or coverage; 

6 ‘‘(iv) the lowest cost per course of treat7 ment or 30-day supply, for such drug, in8 cluding amounts charged to the plan or 

9 issuer and enrollee, that is available from 

10 any pharmacy included in the network of 

11 the plan or coverage. 

12 ‘‘(d) FULL REBATE PASS-THROUGH TO PLAN.— 

13 ‘‘(1) IN GENERAL.—A pharmacy benefits man14 ager, a third-party administrator of a group health 

15 plan, a health insurance issuer offering group health 

16 insurance coverage, or an entity providing pharmacy 

17 benefits management services under such health plan 

18 or health insurance coverage shall remit 100 percent 

19 of rebates, fees, alternative discounts, and all other re20 muneration received from a pharmaceutical manufac21 turer, distributor or any other third party, that are 

22 related to utilization of drugs under such health plan 

23 or health insurance coverage, to the group health 

24 plan. 


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1 ‘‘(2) FORM AND MANNER OF REMITTANCE.—Such 

2 rebates, fees, alternative discounts, and other remu3 neration shall be— 

4 ‘‘(A) remitted to the group health plan in a 

5 timely fashion after the period for which such re6 bates, fees, or other remuneration is calculated, 

7 and in no case later than 90 days after the end 

8 of such period; 

9 ‘‘(B) fully disclosed and enumerated to the 

10 group health plan sponsor, as described in (b)(1); 

11 ‘‘(C) available for audit by the plan spon12 sor, or a third-party designated by a plan spon13 sor no less than once per plan year; and 

14 ‘‘(D) returned to the issuer or entity pro15 viding pharmaceutical benefit management serv16 ices by the group health plan if audits by such 

17 issuer or entity indicate that the amounts re18 ceived are incorrect after such amounts have been 

19 paid to the group health plan. 

20 ‘‘(3) AUDIT OF REBATE CONTRACTS.—A phar21 macy benefits manager, a third-party administrator 

22 of a group health plan, a health insurance issuer of23 fering group health insurance coverage, or an entity 

24 providing pharmacy benefits management services 

25 under such health plan or health insurance coverage 


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1 shall make rebate contracts with drug manufacturers 

2 available for audit by such plan sponsor or des3 ignated third-party, subject to confidentiality agree4 ments to prevent re-disclosure of such contracts. 

5 ‘‘(e) ENFORCEMENT.— 

6 ‘‘(1) IN GENERAL.—The Secretary, in consulta7 tion with the Secretary of Labor and the Secretary of 

8 the Treasury, shall enforce this section. 

9 ‘‘(2) FAILURE TO PROVIDE TIMELY INFORMA10 TION.—A health insurance issuer or an entity pro11 viding pharmacy benefit management services that 

12 violates subsection (a), fails to provide information 

13 required under subsection (b), engages in spread pric14 ing as defined in subsection (c), or fails to comply 

15 with the requirements of subsection (d), or a drug 

16 manufacturer that fails to provide information under 

17 subsection (b)(1)(A), in a timely manner shall be sub18 ject to a civil monetary penalty in the amount of 

19 $10,000 for each day during which such violation 

20 continues or such information is not disclosed or re21 ported. 

22 ‘‘(3) FALSE INFORMATION.—A health insurance 

23 issuer, entity providing pharmacy benefit manage24 ment services, or drug manufacturer that knowingly 

25 provides false information under this section shall be 


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1 subject to a civil money penalty in an amount not to 

2 exceed $100,000 for each item of false information. 

3 Such civil money penalty shall be in addition to other 

4 penalties as may be prescribed by law. 

5 ‘‘(4) PROCEDURE.—The provisions of section 

6 1128A of the Social Security Act, other than sub7 section (a) and (b) and the first sentence of subsection 

8 (c)(1) of such section shall apply to civil monetary 

9 penalties under this subsection in the same manner as 

10 such provisions apply to a penalty or proceeding 

11 under section 1128A of the Social Security Act. 

12 ‘‘(5) SAFE HARBOR.—The Secretary may waive 

13 penalties under paragraph (2), or extend the period 

14 of time for compliance with a requirement of this sec15 tion, for an entity in violation of this section that has 

16 made a good-faith effort to comply with this section. 

17 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec18 tion shall be construed to prohibit payments to entities of19 fering pharmacy benefits management services for bona fide 

20 services using a fee structure not contemplated by this sec21 tion, provided that such fees are transparent to group health 

22 plans and health insurance issuers. 

23 ‘‘(g) DEFINITIONS.—In this section— 

24 ‘‘(1) the term ‘similarly situated pharmacy’ 

25 means, with respect to a particular pharmacy, anVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00353 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 other pharmacy that is approximately the same size 

2 (as measured by the number of prescription drugs dis3 pensed), and that serves patients in the same geo4 graphical area, whether through physical locations or 

5 mail order; and 

6 ‘‘(2) the term ‘wholesale acquisition cost’ has the 

7 meaning given such term in sectionb1847A(c)(6)(B) 

8 of the Social Security Act.’’. 

9 SEC. 307. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 

10 ON PROFIT- AND REVENUE-SHARING IN 

11 HEALTH CARE. 

12 (a) STUDY.—Not later than 1 year after the date of 

13 enactment of this Act, the Comptroller General of the United 

14 States shall conduct a study to— 

15 (1) describe what is known about profit- and 

16 revenue-sharing relationships in the commercial 

17 health care markets, including those relationships 

18 that— 

19 (A) involve one or more— 

20 (i) physician groups that practice 

21 within a hospital included in the profit- or 

22 revenue-sharing relationship, or refer pa23 tients to such hospital; 


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1 (ii) laboratory, radiology, or pharmacy 

2 services that are delivered to privately in3 sured patients of such hospital; 

4 (iii) surgical services; 

5 (iv) hospitals or group purchasing or6 ganizations; or 

7 (v) rehabilitation or physical therapy 

8 facilities or services; and 

9 (B) include revenue- or profit-sharing 

10 whether through a joint venture, management or 

11 professional services agreement, or other form of 

12 gain-sharing contract; 

13 (2) describe Federal oversight of such relation14 ships, including authorities of the Department of 

15 Health and Human Services and the Federal Trade 

16 Commission to review such relationships and their 

17 potential to increase costs for patients, and identify 

18 limitations in such oversight; and 

19 (3) as appropriate, make recommendations to 

20 improve Federal oversight of such relationships. 

21 (b) REPORT.—Not later than 1 year after the date of 

22 enactment of this Act, the Comptroller General of the United 

23 States shall prepare and submit a report on the study con24 ducted under subsection (a) to the Committee on Health, 

25 Education, Labor, and Pensions of the Senate and the ComVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00355 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 mittee on Education and Labor and Committee on Energy 

2 and Commerce of the House of Representatives. 

3 SEC. 308. DISCLOSURE OF DIRECT AND INDIRECT COM4 PENSATION FOR BROKERS AND CONSULT5 ANTS TO EMPLOYER-SPONSORED HEALTH 

6 PLANS AND ENROLLEES IN PLANS ON THE IN7 DIVIDUAL MARKET. 

8 (a) GROUP HEALTH PLANS.—Section 408(b)(2) of the 

9 Employee Retirement Income Security Act of 1974 (29 

10 U.S.C. 1108(b)(2)) is amended— 

11 (1) by striking ‘‘(2) Contracting or making’’ and 

12 inserting ‘‘(2)(A) Contracting or making’’; and 

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

14 ‘‘(B)(i) No contract or arrangement for services 

15 between a covered plan and a covered service pro16 vider, and no extension or renewal of such a contract 

17 or arrangement, is reasonable within the meaning of 

18 this paragraph unless the requirements of this clause 

19 are met. 

20 ‘‘(ii)(I) For purposes of this subparagraph: 

21 ‘‘(aa) The term ‘covered plan’ means a 

22 group health plan as defined section 733(a). 

23 ‘‘(bb) The term ‘covered service provider’ 

24 means a service provider that enters into a con25 tract or arrangement with the covered plan and 


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1 reasonably expects $1,000 (or such amount as the 

2 Secretary may establish in regulations to ac3 count for inflation since the date of enactment of 

4 the Lower Health Care Costs Act, as appro5 priate) or more in compensation, direct or indi6 rect, to be received in connection with providing 

7 one or more of the following services, pursuant to 

8 the contract or arrangement, regardless of wheth9 er such services will be performed, or such com10 pensation received, by the covered service pro11 vider, an affiliate, or a subcontractor: 

12 ‘‘(AA) Brokerage services, for which the 

13 covered service provider, an affiliate, or a 

14 subcontractor reasonably expects to receive 

15 indirect compensation or direct compensa16 tion described in item (dd), provided to a 

17 covered plan with respect to selection of in18 surance products (including vision and den19 tal), recordkeeping services, medical man20 agement vendor, benefits administration 

21 (including vision and dental), stop-loss in22 surance, pharmacy benefit management 

23 services, wellness services, transparency 

24 tools and vendors, group purchasing organi25 zation preferred vendor panels, disease 


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1 management vendors and products, compli2 ance services, employee assistance programs, 

3 or third party administration services. 

4 ‘‘(BB) Consulting, for which the cov5 ered service provider, an affiliate, or a sub6 contractor reasonably expects to receive in7 direct compensation or direct compensation 

8 described in item (dd), related to the devel9 opment or implementation of plan design, 

10 insurance or insurance product selection 

11 (including vision and dental), record12 keeping, medical management, benefits ad13 ministration selection (including vision and 

14 dental), stop-loss insurance, pharmacy ben15 efit management services, wellness design 

16 and management services, transparency 

17 tools, group purchasing organization agree18 ments and services, participation in and 

19 services from preferred vendor panels, dis20 ease management, compliance services, em21 ployee assistance programs, or third party 

22 administration services. 

23 ‘‘(cc) The term ‘affiliate’, with respect to a 

24 covered service provider, means an entity that 

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1 mediaries) controls, is controlled by, or is under 

2 common control with, such provider, or is an of3 ficer, director, or employee of, or partner in, 

4 such provider. 

5 ‘‘(dd)(AA) The term ‘compensation’ means 

6 anything of monetary value, but does not include 

7 non-monetary compensation valued at $250 (or 

8 such amount as the Secretary may establish in 

9 regulations to account for inflation since the date 

10 of enactment of the Lower Health Care Costs Act, 

11 as appropriate) or less, in the aggregate, during 

12 the term of the contract 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, the 

19 covered service provider, or an affiliate. Com20 pensation received from a subcontractor is indi21 rect compensation, unless it is received in con22 nection with services performed under a contract 

23 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 contract 

7 or arrangement with the covered service provider 

8 or an affiliate, reasonably expects to receive 

9 $1,000 (or such amount as the Secretary may es10 tablish in regulations to account for inflation 

11 since the date of enactment of the Lower Health 

12 Care Costs Act, as appropriate) or more in com13 pensation for performing one or more services 

14 described in item (bb) under a contract or ar15 rangement with the covered plan. 

16 ‘‘(II) For purposes of this subparagraph, a de17 scription of compensation or cost may be expressed as 

18 a monetary amount, formula, or a per capita charge 

19 for each enrollee or, if the compensation or cost can20 not reasonably be expressed in such terms, by any 

21 other reasonable method, including a disclosure that 

22 additional compensation may be earned but may not 

23 be calculated at the time of contract if such a disclo24 sure includes a description of the circumstances under 

25 which the additional compensation may be earned 


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1 and a reasonable and good faith estimate if the cov2 ered service provider cannot otherwise readily describe 

3 compensation or cost and explains the methodology 

4 and assumptions used to prepare such estimate. Any 

5 such description shall contain sufficient information 

6 to permit evaluation of the reasonableness of the com7 pensation or cost. 

8 ‘‘(III) No person or entity is a ‘covered service 

9 provider’ within the meaning of subclause (I)(bb) sole10 ly on the basis of providing services as an affiliate or 

11 a subcontractor that is performing one or more of the 

12 services described in subitem (AA) or (BB) of such 

13 subclause under the contract or arrangement with the 

14 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 cov22 ered service provider, an affiliate, or a subcon23 tractor will provide, or reasonably expects to 

24 provide, services pursuant to the contract or arVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00361 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 rangement directly to the covered plan as a fidu2 ciary (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 to 

12 receive in connection with the services described 

13 in subclause (I)— 

14 ‘‘(AA) including compensation from a 

15 vendor to a brokerage firm based on a struc16 ture of incentives not solely related to the 

17 contract with the covered plan; and 

18 ‘‘(BB) not including compensation re19 ceived by an employee from an employer on 

20 account of work performed by the employee. 

21 ‘‘(bb) A description of the arrangement be22 tween the payer and the covered service provider, 

23 an affiliate, or a subcontractor, as applicable, 

24 pursuant to which such indirect compensation is 

25 paid. 


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1 ‘‘(cc) Identification of the services for which 

2 the indirect compensation will be received, if ap3 plicable. 

4 ‘‘(dd) Identification of the payer of the indi5 rect compensation. 

6 ‘‘(V) A description of any compensation 

7 that will be paid among the covered service pro8 vider, an affiliate, or a subcontractor, in connec9 tion with the services described in subclause (I) 

10 if such compensation is set on a transaction 

11 basis (such as commissions, finder’s fees, or other 

12 similar incentive compensation based on business 

13 placed or retained), including identification of 

14 the services for which such compensation will be 

15 paid and identification of the payers and recipi16 ents of such compensation (including the status 

17 of a payer or recipient as an affiliate or a sub18 contractor), regardless of whether such compensa19 tion also is disclosed pursuant to subclause (III) 

20 or (IV). 

21 ‘‘(VI) A description of any compensation 

22 that the covered service provider, an affiliate, or 

23 a subcontractor reasonably expects to receive in 

24 connection with termination of the contract or 

25 arrangement, and how any prepaid amounts 


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1 will be calculated and refunded upon such termi2 nation. 

3 ‘‘(iv) A covered service provider shall disclose to 

4 a responsible plan fiduciary, in writing a description 

5 of the manner in which the compensation described in 

6 clause (iii), as applicable, will be received. 

7 ‘‘(v)(I) A covered service provider shall disclose 

8 the information required under clauses (iii) and (iv) 

9 to the responsible plan fiduciary not later than the 

10 date that is reasonably in advance of the date on 

11 which the contract or arrangement is entered into, 

12 and extended or renewed. 

13 ‘‘(II) A covered service provider shall disclose 

14 any change to the information required under clause 

15 (iii) and (iv) as soon as practicable, but not later 

16 than 60 days from the date on which the covered serv17 ice provider is informed of such change, unless such 

18 disclosure is precluded due to extraordinary cir19 cumstances beyond the covered service provider’s con20 trol, in which case the information shall be disclosed 

21 as soon as practicable. 

22 ‘‘(vi)(I) Upon the written request of the respon23 sible plan fiduciary or covered plan administrator, a 

24 covered service provider shall furnish any other infor25 mation relating to the compensation received in conVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00364 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 nection with the contract or arrangement that is re2 quired for the covered plan to comply with the report3 ing and disclosure requirements under this Act. 

4 ‘‘(II) The covered service provider shall disclose 

5 the information required under clause (iii)(I) reason6 ably in advance of the date upon which such respon7 sible plan fiduciary or covered plan administrator 

8 states that it is required to comply with the applica9 ble reporting or disclosure requirement, unless such 

10 disclosure is precluded due to extraordinary cir11 cumstances beyond the covered service provider’s con12 trol, in which case the information shall be disclosed 

13 as soon as practicable. 

14 ‘‘(vii) No contract or arrangement will fail to be 

15 reasonable under this subparagraph solely because the 

16 covered service provider, acting in good faith and 

17 with reasonable diligence, makes an error or omission 

18 in disclosing the information required pursuant to 

19 clause (iii) (or a change to such information disclosed 

20 pursuant to clause (v)(II)) or clause (vi), provided 

21 that the covered service provider discloses the correct 

22 information to the responsible plan fiduciary as soon 

23 as practicable, but not later than 30 days from the 

24 date on which the covered service provider knows of 

25 such error or omission. 


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1 ‘‘(viii)(I) Pursuant to subsection (a), subpara2 graphs (C) and (D) of section 406(a)(1) shall not 

3 apply to a responsible plan fiduciary, notwith4 standing any failure by a covered service provider to 

5 disclose information required under clause (iii), if the 

6 following conditions are met: 

7 ‘‘(aa) The responsible plan fiduciary did 

8 not know that the covered service provider failed 

9 or would fail to make required disclosures and 

10 reasonably believed that the covered service pro11 vider disclosed the information required to be 

12 disclosed. 

13 ‘‘(bb) The responsible plan fiduciary, upon 

14 discovering that the covered service provider 

15 failed to disclose the required information, re16 quests in writing that the covered service pro17 vider furnish such information. 

18 ‘‘(cc) If the covered service provider fails to 

19 comply with a written request described in sub20 clause (II) within 90 days of the request, the re21 sponsible plan fiduciary notifies the Secretary of 

22 the covered service provider’s failure, in accord23 ance with subclauses (II) and (III). 

24 ‘‘(II) A notice described in subclause (I)(cc) shall 

25 contain— 


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1 ‘‘(aa) the name of the covered plan; 

2 ‘‘(bb) the plan number used for the annual 

3 report on the covered plan; 

4 ‘‘(cc) the plan sponsor’s name, address, and 

5 employer identification number; 

6 ‘‘(dd) the name, address, and telephone 

7 number of the responsible plan fiduciary; 

8 ‘‘(ee) the name, address, phone number, 

9 and, if known, employer identification number of 

10 the covered service provider; 

11 ‘‘(ff) a description of the services provided 

12 to the covered plan; 

13 ‘‘(gg) a description of the information that 

14 the covered service provider failed to disclose; 

15 ‘‘(hh) the date on which such information 

16 was requested in writing from the covered service 

17 provider; and 

18 ‘‘(ii) a statement as to whether the covered 

19 service provider continues to provide services to 

20 the plan. 

21 ‘‘(III) A notice described in subclause (I)(cc) 

22 shall be filed with the Department not later than 30 

23 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 writ3 ten request described in subclause (I)(bb); or 

4 ‘‘(bb) 90 days after the written request re5 ferred to in subclause (I)(cc) is made. 

6 ‘‘(IV) If the covered service provider fails to com7 ply with the written request under subclause (I)(bb) 

8 within 90 days of such request, the responsible plan 

9 fiduciary shall determine whether to terminate or 

10 continue the contract or arrangement under section 

11 404. If the requested information relates to future 

12 services and is not disclosed promptly after the end 

13 of the 90-day period, the responsible plan fiduciary 

14 shall terminate the contract or arrangement as expe15 ditiously as possible, consistent with such duty of 

16 prudence. 

17 ‘‘(ix) Nothing in this subparagraph shall be con18 strued to supersede any provision of State law that 

19 governs disclosures by parties that provide the services 

20 described in this section, except to the extent that such 

21 law prevents the application of a requirement of this 

22 section.’’. 

23 (b) APPLICABILITY OF EXISTING REGULATIONS.— 

24 Nothing in the amendments made by subsection (a) shall 

25 be construed to affect the applicability of section 2550.408b– 


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1 2 of title 29, Code of Federal Regulations (or any successor 

2 regulations), with respect to any applicable entity other 

3 than a covered plan or a covered service provider (as de4 fined in section 408(b)(2)(B)(ii) of the Employee Retire5 ment Income Security Act of 1974, as amended by sub6 section (a)). 

7 (c) INDIVIDUAL MARKET COVERAGE.—Subpart 1 of 

8 part B of title XXVII of the Public Health Service Act (42 

9 U.S.C. 300gg–41 et seq.) is amended by adding at the end 

10 the following: 

11 ‘‘SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL 

12 MARKET COVERAGE. 

13 ‘‘(a) IN GENERAL.—A health insurance issuer offering 

14 individual health insurance coverage shall make disclosures 

15 to enrollees in such coverage, as described in subsection (b), 

16 and reports to the Secretary, as described in subsection (c), 

17 regarding direct or indirect compensation provided to an 

18 agent or broker associated with enrolling individuals in 

19 such coverage. 

20 ‘‘(b) DISCLOSURE.—A health insurance issuer de21 scribed in subsection (a) shall disclose to an enrollee the 

22 amount of direct or indirect compensation provided to an 

23 agent or broker for services provided by such agent or broker 

24 associated with plan selection and enrollment. Such disclo25 sure shall be— 


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1 ‘‘(1) made prior to the individual finalizing 

2 plan selection; and 

3 ‘‘(2) included on any documentation confirming 

4 the individual’s enrollment. 

5 ‘‘(c) REPORTING.—A health insurance issuer described 

6 in subsection (a) shall annually report to the Secretary, 

7 prior to the beginning of open enrollment, any direct or 

8 indirect compensation provided to an agent or broker asso9 ciated with enrolling individuals in such coverage. 

10 ‘‘(d) RULEMAKING.—Not later than 1 year after the 

11 date of enactment of the Lower Health Care Costs Act, the 

12 Secretary shall finalize, through notice-and-comment rule13 making, the form and manner in which issuers described 

14 in subsection (a) are required to make the disclosures de15 scribed in subsection (b) and the reports described in sub16 section (c).’’. 

17 (d) TRANSITION RULE.—No contract executed prior to 

18 the effective date described in subsection (e) by a group 

19 health plan subject to the requirements of section 

20 408(b)(2)(B) of the Employee Retirement Income Security 

21 Act of 1974 (as amended by subsection (a)) or by a health 

22 insurance issuer subject to the requirements of section 2746 

23 of the Public Health Service Act (as added by subsection 

24 (c)) shall be subject to the requirements of such section 408( 

25 b)(2)(B) or such section 2746, as applicable. 


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1 (e) EFFECTIVE DATE.—The amendments made by sub2 sections (a) and (c) shall take effect 2 years after the date 

3 of enactment of this Act. 

4 SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING 

5 INFORMATION. 

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

7 of the Public Health Service Act (42 U.S.C. 300gg–11 et 

8 seq.), as amended by section 306, is further amended by 

9 adding at the end the following: 

10 ‘‘SEC. 2729F. PROVISION OF COST-SHARING INFORMATION. 

11 ‘‘(a) PROVIDER DISCLOSURES.—A provider that is in12 network with respect to a group health plan or a health 

13 insurance issuer offering group or individual health insur14 ance coverage shall provide to an enrollee in the plan or 

15 coverage who submits a request for the information de16 scribed in paragraph (1) or (2), together with accurate and 

17 complete information about the enrollee’s coverage under the 

18 applicable plan or coverage— 

19 ‘‘(1) as soon as practicable and not later than 2 

20 business days after the enrollee requests such informa21 tion, a good faith estimate of the expected enrollee 

22 cost-sharing for the provision of a particular health 

23 care service (including any service that is reasonably 

24 expected to be provided in conjunction with such spe25 cific service); and 


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1 ‘‘(2) as soon as practicable and not later than 2 

2 business days after an enrollee requests such informa3 tion, the contact information for any ancillary pro4 viders for a scheduled health care service. 

5 ‘‘(b) INSURER DISCLOSURES.—A group health plan or 

6 a health insurance issuer offering group or individual 

7 health insurance coverage shall provide an enrollee in the 

8 plan or coverage with a good faith estimate of the enrollee’s 

9 cost-sharing (including deductibles, copayments, and coin10 surance) for which the enrollee would be responsible for pay11 ing with respect to a specific health care service (including 

12 any service that is reasonably expected to be provided in 

13 conjunction with such specific service), as soon as prac14 ticable and not later than 2 business days after a request 

15 for such information by an enrollee. 

16 ‘‘(c) ENFORCEMENT.— 

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

18 health care provider that violates a requirement under 

19 subsection (a) shall be subject to a civil monetary 

20 penalty of not more than $10,000 for each act consti21 tuting such violation. 

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

23 1128A of the Social Security Act, other than sub24 sections (a) and (b) and the first sentence of sub25 section (c)(1) of such section, shall apply to civil 


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1 money penalties under this subsection in the same 

2 manner as such provisions apply to a penalty or pro3 ceeding under section 1128A of the Social Security 

4 Act.’’. 

5 (b) EFFECTIVE DATE.—Section 2729G of the Public 

6 Health Service Act, as added by subsection (a), shall apply 

7 with respect to plan years beginning on or after the date 

8 that is 18 months after the date of enactment of this Act. 

9 SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH 

10 AND SUBSTANCE USE DISORDER BENEFITS. 

11 Section 2726 of the Public Health Service Act (42 

12 U.S.C. 300gg–26) is amended— 

13 (1) in subsection (a), by adding at the end the 

14 following: 

15 ‘‘(8) COMPLIANCE REQUIREMENTS.— 

16 ‘‘(A) NONQUANTITATIVE TREATMENT LIMI17 TATION (NQTL) REQUIREMENTS.—In the case of a 

18 group health plan or a health insurance issuer 

19 offering group or individual health insurance 

20 coverage that provides both medical and surgical 

21 benefits and mental health or substance use dis22 order benefits and that imposes nonquantitative 

23 treatment limitations (referred to in this section 

24 as ‘NQTL’) on mental health or substance use 

25 disorder benefits, the plan or issuer offering 


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1 health insurance coverage in connection with 

2 such a plan, shall perform comparative analyses 

3 of the design and application of NQTLs in ac4 cordance with the following process, and make 

5 available to the applicable State authority (or, 

6 as applicable, to the Secretary of Labor with re7 spect to group health plans or the Secretary of 

8 Health and Human Services with respect to 

9 health insurance coverage), upon request within 

10 60 days beginning 6 months after the date of en11 actment of the Lower Health Care Costs Act, the 

12 following information: 

13 ‘‘(i) The specific plan or coverage 

14 terms regarding the NQTL, that applies to 

15 such plan or coverage, and a description of 

16 all mental health or substance use disorder 

17 and medical or surgical benefits to which it 

18 applies in each respective benefits classifica19 tion. 

20 ‘‘(ii) The factors used to determine that 

21 the NQTL will apply to mental health or 

22 substance use disorder benefits and medical 

23 or surgical benefits. 

24 ‘‘(iii) The evidentiary standards used 

25 for the factors identified in clause (ii), when 


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1 applicable, provided that every factor shall 

2 be defined and any other source or evidence 

3 relied upon to design and apply the NQTL 

4 to mental health or substance use disorder 

5 benefits and medical or surgical benefits. 

6 ‘‘(iv) The comparative analyses dem7 onstrating that the processes, strategies, evi8 dentiary standards, and other factors used 

9 to design the NQTL, as written, and the op10 eration processes and strategies as written 

11 and in operation that are used to apply the 

12 NQTL for mental health or substance use 

13 disorder benefits are comparable to, and are 

14 applied no more stringently than, the proc15 esses, strategies, evidentiary standards, and 

16 other factors used to design the NQTL, as 

17 written, and the operation processes and 

18 strategies as written and in operation that 

19 are used to apply the NQTL to medical or 

20 surgical benefits. 

21 ‘‘(v) A disclosure of the specific find22 ings and conclusions reached by the plan or 

23 coverage that the results of the analyses de24 scribed in this subparagraph indicate that 


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1 the plan or coverage is in compliance with 

2 this section. 

3 ‘‘(B) SECRETARY REQUEST PROCESS.— 

4 ‘‘(i) SUBMISSION UPON REQUEST.— 

5 With respect to group health plans or health 

6 insurance coverage for which the Secretary 

7 is enforcing this section in accordance with 

8 section 2723, the Secretary, in consultation 

9 with the Secretary of Labor and the Sec10 retary of Treasury, shall request that a 

11 group health plan or a health insurance 

12 issuer offering group or individual health 

13 insurance coverage submit the comparative 

14 analyses described in subparagraph (A) for 

15 plans that involve potential violations of 

16 this section concerning NQTLs and any 

17 other instances in which the Secretary de18 termines appropriate. The Secretary shall 

19 request not fewer than 20 such analyses per 

20 year. 

21 ‘‘(ii) ADDITIONAL INFORMATION.—In 

22 instances in which the Secretary has con23 cluded that the plan or coverage has not 

24 submitted sufficient information for the Sec25 retary to review the comparative analyses 


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1 described in subparagraph (A), as requested 

2 under clause (i), the Secretary shall specify 

3 to the plan or coverage the information the 

4 plan or coverage must submit to be respon5 sive to the request under clause (i) for the 

6 Secretary to review the comparative anal7 yses described in subparagraph(A) for com8 pliance with this section. Nothing in this 

9 paragraph shall require the Secretary to 

10 conclude that a plan is in compliance with 

11 this section solely based upon the inspection 

12 of the comparative analyses described in 

13 subparagraph (A), as requested under clause 

14 (i). 

15 ‘‘(iii) REQUIRED ACTION.—In in16 stances in which the Secretary has reviewed 

17 the comparative analyses described in sub18 paragraph (A), as requested under clause 

19 (i), and determined that the plan or cov20 erage is not in compliance with this section, 

21 the plan or coverage shall specify to the Sec22 retary the actions the plan or coverage will 

23 take to be in compliance with this section. 

24 Documents or communications produced in 

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1 ommendations to the plan or coverage shall 

2 not be subject to disclosure pursuant to sec3 tion 552 of title 5, United States Code. 

4 ‘‘(iv) REPORT.—Not later than 1 year 

5 after the date of enactment of this para6 graph, and annually thereafter, the Sec7 retary shall submit to the Committee on 

8 Education and Labor of the House of Rep9 resentatives and the Committee on Health, 

10 Education, Labor, and Pensions of the Sen11 ate a report that contains— 

12 ‘‘(I) a summary of the compara13 tive analyses requested under clause 

14 (i), except that the identity of each 

15 plan or coverage and any contracted 

16 entity of a plan or coverage shall be re17 dacted; 

18 ‘‘(II) the Secretary’s conclusions 

19 as to whether each plan or coverage 

20 submitted sufficient information for the 

21 Secretary to review the comparative 

22 analyses requested under clause (i) for 

23 compliance with this section; 

24 ‘‘(III) for each plan or coverage 

25 that did submit sufficient information 


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1 for the Secretary to review the com2 parative analyses requested under 

3 clause (i), the Secretary’s conclusions 

4 as to whether and why the plan or cov5 erage is in compliance with the disclo6 sure requirements under this section; 

7 ‘‘(IV) the Secretary’s specifica8 tions described in clause (ii) for each 

9 plan or coverage that the Secretary de10 termined did not submit sufficient in11 formation for the Secretary to review 

12 the comparative analyses requested 

13 under clause (i) for compliance with 

14 this section; and 

15 ‘‘(V) the Secretary’s specifications 

16 described in clause (iii) of the actions 

17 each plan or coverage that the Sec18 retary determined is not in compliance 

19 with this section must take to be in 

20 compliance with this section, including 

21 the reason why the Secretary deter22 mined the plan or coverage is not in 

23 compliance. 

24 ‘‘(C) COMPLIANCE PROGRAM GUIDANCE

25 DOCUMENT UPDATE PROCESS.— 


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1 ‘‘(i) IN GENERAL.—The Secretary shall 

2 include select instances of noncompliance 

3 that the Secretary discovers upon reviewing 

4 the comparative analyses requested under 

5 subparagraph (B)(i) in the compliance pro6 gram guidance document described in sec7 tion 2726(a)(6), as it is updated every 2 

8 years, except that all instances shall be 

9 deidentified and such instances shall not 

10 disclose any protected health information or 

11 individually identifiable information. 

12 ‘‘(ii) GUIDANCE AND REGULATIONS.— 

13 Not later than 18 months after the date of 

14 enactment of this paragraph, the Secretary 

15 shall finalize any draft or interim guidance 

16 and regulations relating to mental health 

17 parity under this section. 

18 ‘‘(iii) STATE.—The Secretary shall 

19 share information on findings of compliance 

20 and noncompliance discovered upon review21 ing the comparative analyses requested 

22 under subparagraph (B)(i) shall be shared 

23 with the State where the group health plan 

24 is located or the State where the health in25 surance issuer is licensed to do business for 


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1 coverage offered by a health insurance issuer 

2 in the group market, in accordance with 

3 section 2726(a)(6)(B)(iii)(II).’’. 

4 SEC. 311. TECHNICAL AMENDMENTS. 

5 (a) ERISA.—Section 715 of the Employee Retirement 

6 Income Security Act of 1974 (29 U.S.C. 1185d) is amend7 ed— 

8 (1) in subsection (a)(1), by striking ‘‘(as amend9 ed by the Patient Protection and Affordable Care 

10 Act)’’ and inserting ‘‘(including any subsequent 

11 amendments to such part)’’; and 

12 (2) in subsection (b)— 

13 (A) by striking ‘‘(as amended by the Patient 

14 Protection and Affordable Care Act)’’ and insert15 ing ‘‘(including any subsequent amendments to 

16 such part)’’; and 

17 (B) by striking ‘‘(as so amended)’’. 

18 (b) IRC.—Section 9815 of the Internal Revenue Code 

19 of 1986 is amended— 

20 (1) in subsection (a)(1), by striking ‘‘(as amend21 ed by the Patient Protection and Affordable Care 

22 Act)’’ and inserting ‘‘(including any subsequent 

23 amendments to such part)’’; and 

24 (2) in subsection (b)— 


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1 (A) by striking ‘‘(as amended by the Patient 

2 Protection and Affordable Care Act)’’ and insert3 ing ‘‘(including any subsequent amendments to 

4 such part)’’; and 

5 (B) by striking ‘‘(as so amended)’’. 

6 (c) APPLICABILITY.—The amendments made by sub7 sections (a) and (b) shall take effect as though included in 

8 the enactment of the Patient Protection and Affordable Care 

9 Act (Public Law 111–148). 

10 SEC. 312. THIRD-PARTY ADMINISTRATORS. 

11 Any obligation on a third-party administrator under 

12 this Act (including the amendments made by this Act) shall 

13 not affect any other direct or indirect requirement under 

14 any other provision Federal law that applies to third-party 

15 administrators offering services to group health plans. 

16 SEC. 313. GROUP HEALTH PLAN REPORTING REQUIRE17 MENTS. 

18 Part C of title XXVII of the Public Health Service Act 

19 (42 U.S.C. 300gg–91 et seq.), as amended by section 303, 

20 is further amended by adding at the end the following: 

21 ‘‘SEC. 2797. GROUP HEALTH PLAN REPORTING. 

22 ‘‘(a) IN GENERAL.—A group health plan or health in23 surance issuer offering group or individual health insur24 ance coverage shall submit to the Secretary, not later than 


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1 March 1 of each year, the following information with re2 spect to the health plan in the previous plan year: 

3 ‘‘(1) The beginning and end dates of the plan 

4 year. 

5 ‘‘(2) The number of enrollees. 

6 ‘‘(3) Each State in which the plan is offered. 

7 ‘‘(4) The 50 brand prescription drugs most fre8 quently dispensed by pharmacies for claims paid by 

9 the issuer, and the total number of paid claims for 

10 each such drug. 

11 ‘‘(5) The 50 most costly prescription drugs with 

12 respect to the plan by total annual spending, and the 

13 annual amount spent by the plan for each such drug. 

14 ‘‘(6) The 50 prescription drugs with the greatest 

15 increase in plan expenditures over the plan year pre16 ceding the plan year that is the subject of the report, 

17 and, for each such drug, the change in amounts ex18 pended by the plan in each such plan year. 

19 ‘‘(7) Total spending on health care services by 

20 such group health plan, broken down by— 

21 ‘‘(A) the type of costs, including— 

22 ‘‘(i) hospital costs; 

23 ‘‘(ii) health care provider and clinical 

24 service costs; 

25 ‘‘(iii) costs for prescription drugs; and 


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1 ‘‘(iv) other medical costs; and 

2 ‘‘(B) spending on prescription drugs by— 

3 ‘‘(i) the health plan; and 

4 ‘‘(ii) the enrollees. 

5 ‘‘(8) The average monthly premium— 

6 ‘‘(A) paid by employers on behalf of enroll7 ees; and 

8 ‘‘(B) paid by enrollees. 

9 ‘‘(9) Any impact on premiums by rebates, fees, 

10 and any other remuneration paid by drug manufac11 turers to the plan or its administrators or service pro12 viders, with respect to prescription drugs prescribed 

13 to enrollees in the plan, including— 

14 ‘‘(A) the amounts so paid for each thera15 peutic class of drugs; and 

16 ‘‘(B) the amounts so paid for each of the 25 

17 drugs that yielded the highest amount of rebates 

18 and other remuneration under the plan from 

19 drug manufacturers during the plan year. 

20 ‘‘(10) Any reduction in premiums and out-of21 pocket costs associated with rebates, fees, or other re22 muneration described in paragraph (9). 

23 ‘‘(b) REPORT.—Not later than 18 months after the date 

24 on which the first report is required under subsection (a) 

25 and biannually thereafter, the Secretary, acting through the 


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1 Assistant Secretary of Planning and Evaluation and in co2 ordination with the Inspector General of the Department 

3 of Health and Human Services, shall make available on the 

4 internet website of the Department of Health and Human 

5 Services a report on prescription drug reimbursements 

6 under group health plans, prescription drug pricing trends, 

7 and the role of prescription drug costs in contributing to 

8 premium increases or decreases under such plans, aggre9 gated in such a way as no drug or plan specific information 

10 will be made public. 

11 ‘‘(c) PRIVACY PROTECTIONS.—No confidential or trade 

12 secret information submitted to the Secretary under sub13 section (a) shall be included in the report under subsection 

14 (b).’’. 

15 SEC. 314. STUDY BY COMPTROLLER GENERAL OF UNITED 

16 STATES. 

17 (a) IN GENERAL.—The Comptroller General of the 

18 United States (referred to in this section as the ‘‘Comp19 troller General’’) shall, in consultation with appropriate 

20 stakeholders, conduct a study on the role of pharmacy ben21 efit managers. 

22 (b) PERMISSIBLE EXAMINATION.—In conducting the 

23 study required under subsection (a), the Comptroller Gen24 eral may examine various qualitative and quantitative asVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00385 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 pects of the role of pharmacy benefit managers, such as the 

2 following: 

3 (1) The role that pharmacy benefit managers 

4 play in the pharmaceutical supply chain. 

5 (2) The state of competition among pharmacy 

6 benefit managers, including the market share for the 

7 Nation’s largest pharmacy benefit managers. 

8 (3) The use of rebates and fees by pharmacy ben9 efit managers, including— 

10 (A) the extent to which rebates are passed 

11 on to health plans and whether such rebates are 

12 passed on to individuals enrolled in such plans; 

13 (B) the extent to which rebates are kept by 

14 such pharmacy benefit managers; and 

15 (C) the role of any fees charged by such 

16 pharmacy benefit managers. 

17 (4) Whether pharmacy benefit managers struc18 ture their formularies in favor of high-rebate prescrip19 tion drugs over lower-cost, lower-rebate alternatives. 

20 (5) The average prior authorization approval 

21 time for pharmacy benefit managers. 

22 (6) Factors affecting the use of step therapy by 

23 pharmacy benefit managers. 

24 (c) REPORT.—Not later than 3 years after the date of 

25 enactment of this Act, the Comptroller General shall submit 


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1 to the Secretary of Health and Human Services, the Com2 mittee on Health, Education, Labor, and Pensions of the 

3 Senate, and the Committee on Energy and Commerce of 

4 the House of Representatives a report containing the results 

5 of the study conducted under subsection (a), including pol6 icy recommendations. 

7 TITLE IV—IMPROVING PUBLIC 

8 HEALTH 

9 SEC. 401. IMPROVING AWARENESS OF DISEASE PREVEN10 TION. 

11 The Public Health Service Act is amended by striking 

12 section 313 of such Act (42 U.S.C. 245) and inserting the 

13 following: 

14 ‘‘SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPOR15 TANCE OF VACCINATIONS. 

16 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

17 Director of the Centers for Disease Control and Prevention 

18 and in coordination with other offices and agencies, as ap19 propriate, shall award competitive grants to one or more 

20 public or private entities to carry out a national, evidence21 based campaign to increase awareness and knowledge of the 

22 safety and effectiveness of vaccines for the prevention and 

23 control of diseases, combat misinformation about vaccines, 

24 and disseminate scientific and evidence-based vaccine-re25 lated information, with the goal of increasing rates of vacVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00387 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 cination across all ages, as applicable, particularly in com2 munities with low rates of vaccination, to reduce and elimi3 nate vaccine-preventable diseases. 

4 ‘‘(b) CONSULTATION.—In carrying out the campaign 

5 under this section, the Secretary shall consult with appro6 priate public health and medical experts, including the Na7 tional Academy of Medicine and medical and public health 

8 associations and nonprofit organizations, in the develop9 ment, implementation, and evaluation of the evidence-based 

10 public awareness campaign. 

11 ‘‘(c) REQUIREMENTS.—The campaign under this sec12 tion shall— 

13 ‘‘(1) be a national, evidence-based initiative; 

14 ‘‘(2) include the development of resources for 

15 communities with low rates of vaccination, including 

16 culturally- and linguistically-appropriate resources, 

17 as applicable; 

18 ‘‘(3) include the dissemination of vaccine infor19 mation and communication resources to public health 

20 departments, health care providers, and health care 

21 facilities, including such providers and facilities that 

22 provide prenatal and pediatric care; 

23 ‘‘(4) be complementary to, and coordinated with, 

24 any other Federal, State, local, or Tribal efforts, as 

25 appropriate; and 


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1 ‘‘(5) assess the effectiveness of communication 

2 strategies to increase rates of vaccination. 

3 ‘‘(d) ADDITIONAL ACTIVITIES.—The campaign under 

4 this section may— 

5 ‘‘(1) include the use of television, radio, the 

6 internet, and other media and telecommunications 

7 technologies; 

8 ‘‘(2) be focused to address specific needs of com9 munities and populations with low rates of vaccina10 tion; and 

11 ‘‘(3) include the dissemination of scientific and 

12 evidence-based vaccine-related information, such as— 

13 ‘‘(A) advancements in evidence-based re14 search related to diseases that may be prevented 

15 by vaccines and vaccine development; 

16 ‘‘(B) information on vaccinations for indi17 viduals and communities, including individuals 

18 for whom vaccines are not recommended by the 

19 Advisory Committee for Immunization Practices, 

20 and the effects of low vaccination rates within a 

21 community on such individuals; 

22 ‘‘(C) information on diseases that may be 

23 prevented by vaccines; and 

24 ‘‘(D) information on vaccine safety and the 

25 systems in place to monitor vaccine safety. 


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1 ‘‘(e) EVALUATION.—The Secretary shall— 

2 ‘‘(1) establish benchmarks and metrics to quan3 titatively measure and evaluate the awareness cam4 paign under this section; 

5 ‘‘(2) conduct qualitative assessments regarding 

6 the awareness campaign under this section; and 

7 ‘‘(3) prepare and submit to the Committee on 

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

9 and Committee on Energy and Commerce of the 

10 House of Representatives an evaluation of the aware11 ness campaign under this section. 

12 ‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro13 priated under this section shall be used to supplement and 

14 not supplant other Federal, State, and local public funds 

15 provided for activities described in this section. 

16 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated to carry out this section 

18 and section 317(k) such sums as may be necessary for fiscal 

19 years 2020 through 2024.’’. 

20 SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE 

21 DISEASES. 

22 (a) IN GENERAL.—Section 317(k)(1) of the Public 

23 Health Service Act (42 U.S.C. 247b(k)(1)) is amended— 

24 (1) in subparagraph (C), by striking ‘‘; and’’ 

25 and inserting a semicolon; 


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1 (2) in subparagraph (D), by striking the period 

2 and inserting a semicolon; and 

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

4 ‘‘(E) planning, implementation, and evaluation 

5 of activities to address vaccine-preventable diseases, 

6 including activities to— 

7 ‘‘(i) identify communities at high risk of 

8 outbreaks related to vaccine-preventable diseases, 

9 including through improved data collection and 

10 analysis; 

11 ‘‘(ii) pilot innovative approaches to improve 

12 vaccination rates in communities and among 

13 populations with low rates of vaccination; 

14 ‘‘(iii) reduce barriers to accessing vaccines 

15 and evidence-based information about the health 

16 effects of vaccines; 

17 ‘‘(iv) partner with community organiza18 tions and health care providers to develop and 

19 deliver evidence-based interventions, including 

20 culturally- and linguistically-appropriate inter21 ventions, to increase vaccination rates; 

22 ‘‘(v) improve delivery of evidence-based vac23 cine-related information to parents and others; 

24 and 


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1 ‘‘(vi) improve the ability of State, local, 

2 tribal, and territorial public health departments 

3 to engage communities at high risk for outbreaks 

4 related to vaccine-preventable diseases; and 

5 ‘‘(F) research related to strategies for improving 

6 awareness of scientific and evidence-based vaccine-re7 lated information, including for communities with 

8 low rates of vaccination, in order to understand bar9 riers to vaccination, improve vaccination rates, and 

10 assess the public health outcomes of such strategies.’’. 

11 (b) SUPPLEMENTAL GRANT FUNDS.—Section 

12 330(d)(1) of the Public Health Service Act (42 U.S.C. 254b) 

13 is amended— 

14 (1) in subparagraph (F), by striking ‘‘and’’ at 

15 the end; 

16 (2) in subparagraph (G), by striking the period 

17 and and inserting ‘‘; and’’; and 

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

19 ‘‘(H) improving access to recommended im20 munizations.’’. 

21 SEC. 403. GUIDE ON EVIDENCE-BASED STRATEGIES FOR 

22 PUBLIC HEALTH DEPARTMENT OBESITY PRE23 VENTION PROGRAMS. 

24 (a) DEVELOPMENT AND DISSEMINATION OF AN EVI25 DENCE-BASED STRATEGIES GUIDE.—The Secretary of 


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1 Health and Human Services (referred to in this section as 

2 the ‘‘Secretary’’), acting through the Director of the Centers 

3 for Disease Control and Prevention, not later than 2 years 

4 after the date of enactment of this Act, shall— 

5 (1) develop a guide on evidence-based strategies 

6 for State, territorial, and local health departments to 

7 use to build and maintain effective obesity prevention 

8 and reduction programs, and, in consultation with 

9 Indian Tribes and Tribal organizations, a guide on 

10 such evidence-based strategies with respect to Indian 

11 Tribes and Tribal organizations for such Indian 

12 Tribes and Tribal organizations to use for such pur13 pose, both of which guides shall— 

14 (A) describe an integrated program struc15 ture for implementing interventions proven to be 

16 effective in preventing and reducing the inci17 dence of obesity; and 

18 (B) recommend— 

19 (i) optimal resources, including staff20 ing and infrastructure, for promoting nutri21 tion and obesity prevention and reduction; 

22 and 

23 (ii) strategies for effective obesity pre24 vention programs for State, territorial, and 

25 local health departments, Indian Tribes, 


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1 and Tribal organizations, including strate2 gies related to— 

3 (I) the application of evidence4 based and evidence-informed practices 

5 to prevent and reduce obesity rates; 

6 (II) the development, implementa7 tion, and evaluation of obesity preven8 tion and reduction strategies for spe9 cific communities and populations; 

10 (III) demonstrated knowledge of 

11 obesity prevention practices that reduce 

12 associated preventable diseases, health 

13 conditions, death, and health care 

14 costs; 

15 (IV) best practices for the coordi16 nation of efforts to prevent and reduce 

17 obesity and related chronic diseases; 

18 (V) addressing the underlying risk 

19 factors and social determinants of 

20 health that impact obesity rates; and 

21 (VI) interdisciplinary coordina22 tion between relevant public health of23 ficials specializing in fields such as 

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1 plementation, and collaboration be2 tween public health officials, commu3 nity-based organizations, and others, 

4 as appropriate; and 

5 (2) disseminate the guides and current research, 

6 evidence-based practices, tools, and educational mate7 rials related to obesity prevention, consistent with the 

8 guide, to State, territorial, and local health depart9 ments, Indian Tribes, and Tribal organizations. 

10 (b) TECHNICAL ASSISTANCE.—The Secretary, acting 

11 through the Director of the Centers for Disease Control and 

12 Prevention, shall provide technical assistance to State, ter13 ritorial, and local health departments, Indian Tribes, and 

14 Tribal organizations to support such health departments in 

15 implementing the guide developed under subsection (a)(1). 

16 (c) INDIAN TRIBES; TRIBAL ORGANIZATIONS.—The 

17 terms ‘‘Indian Tribe’’ and ‘‘Tribal organization’’ have the 

18 meanings given the terms ‘‘Indian tribe’’ and ‘‘tribal orga19 nization’’, respectively, in section 4 of the Indian Self-De20 termination and Education Assistance Act (25 U.S.C. 

21 5304). 

22 SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES. 

23 Title III of the Public Health Service Act is amended 

24 by inserting after section 330M (42 U.S.C. 254c–19) the 

25 following: 


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1 ‘‘SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUT2 COMES. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible enti5 ty’ means an entity providing health care services in 

6 rural areas, frontier areas, health professional short7 age areas, or medically underserved areas, or to medi8 cally underserved populations or Native Americans, 

9 including Indian tribes or tribal organizations. 

10 ‘‘(2) HEALTH PROFESSIONAL SHORTAGE

11 AREA.—The term ‘health professional shortage area’ 

12 means a health professional shortage area designated 

13 under section 332. 

14 ‘‘(3) INDIAN TRIBE.—The terms ‘Indian tribe’ 

15 and ‘tribal organization’ have the meanings given 

16 such terms in section 4 of the Indian Self-Determina17 tion and Education Assistance Act. 

18 ‘‘(4) MEDICALLY UNDERSERVED POPULATION.— 

19 The term ‘medically underserved population’ has the 

20 meaning given the term in section 330(b)(3). 

21 ‘‘(5) NATIVE AMERICANS.—The term ‘Native 

22 Americans’ has the meaning given such term in sec23 tion 736 and includes Indian tribes and tribal orga24 nizations. 

25 ‘‘(6) TECHNOLOGY-ENABLED COLLABORATIVE

26 LEARNING AND CAPACITY BUILDING MODEL.—The 


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1 term ‘technology-enabled collaborative learning and 

2 capacity building model’ means a distance health 

3 education model that connects health care profes4 sionals, and particularly specialists, with multiple 

5 other health care professionals through simultaneous 

6 interactive videoconferencing for the purpose of facili7 tating case-based learning, disseminating best prac8 tices, and evaluating outcomes. 

9 ‘‘(b) PROGRAM ESTABLISHED.—The Secretary shall, 

10 as appropriate, award grants to evaluate, develop, and, as 

11 appropriate, expand the use of technology-enabled collabo12 rative learning and capacity building models, to increase 

13 access to health care services, such as those to address chron14 ic diseases and conditions, mental health, substance use dis15 orders, prenatal and maternal health, pediatric care, pain 

16 management, palliative care, and other specialty care in 

17 rural areas, frontier areas, health professional shortage 

18 areas, or medically underserved areas and for medically un19 derserved populations or Native Americans, including In20 dian Tribes and Tribal organizations. 

21 ‘‘(c) USE OF FUNDS.— 

22 ‘‘(1) IN GENERAL.—Grants awarded under sub23 section (b) shall be used for— 

24 ‘‘(A) the development and acquisition of in25 structional programming, and the training of 


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1 health care providers and other professionals that 

2 provide or assist in the provision of services 

3 through such models; 

4 ‘‘(B) information collection and evaluation 

5 activities to study the impact of such models on 

6 patient outcomes and health care providers, and 

7 to identify best practices for the expansion and 

8 use of such models; or 

9 ‘‘(C) other activities consistent with achiev10 ing the objectives of the grants awarded under 

11 this section, as determined by the Secretary. 

12 ‘‘(2) OTHER USES.—In addition to any of the 

13 uses under paragraph (1), grants awarded under sub14 section (b) may be used for— 

15 ‘‘(A) equipment to support the use and ex16 pansion of technology-enabled collaborative 

17 learning and capacity building models, includ18 ing for hardware and software that enables dis19 tance learning, health care provider support, and 

20 the secure exchange of electronic health informa21 tion; or 

22 ‘‘(B) support for health care providers and 

23 other professionals that provide or assist in the 

24 provision of services through such models. 


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1 ‘‘(d) LENGTH OF GRANTS.—Grants awarded under 

2 subsection (b) shall be for a period of up to 5 years. 

3 ‘‘(e) APPLICATION.—An eligible entity that seeks to re4 ceive a grant under subsection (b) shall submit to the Sec5 retary an application, at such time, in such manner, and 

6 containing such information as the Secretary may require. 

7 Such application criteria shall include an assessment of the 

8 effect of technology-enabled collaborative learning and ca9 pacity building models on patient outcomes and health care 

10 providers. 

11 ‘‘(f) ACCESS TO BROADBAND.—In administering 

12 grants under this section, the Secretary may coordinate 

13 with other agencies to ensure that funding opportunities are 

14 available to support access to reliable, high-speed internet 

15 for grantees. 

16 ‘‘(g) TECHNICAL ASSISTANCE.—The Secretary shall 

17 provide (either directly through the Department of Health 

18 and Human Services or by contract) technical assistance 

19 to eligible entities, including recipients of grants under sub20 section (b), on the development, use, and evaluation of tech21 nology-enabled collaborative learning and capacity building 

22 models in order to expand access to health care services pro23 vided by such entities, including for medically underserved 

24 areas and to medically underserved populations or Native 


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1 Americans, including Indian tribes and Tribal organiza2 tions. 

3 ‘‘(h) RESEARCH AND EVALUATION.—The Secretary, in 

4 consultation with stakeholders with appropriate expertise 

5 in such models, shall develop a strategic plan to research 

6 and evaluate the evidence for such models. The Secretary 

7 shall use such plan to inform the activities carried out 

8 under this section. 

9 ‘‘(i) REPORT BY SECRETARY.—Not later than 4 years 

10 after the date of enactment of this section, the Secretary 

11 shall prepare and submit to the Committee on Health, Edu12 cation, Labor, and Pensions of the Senate and the Com13 mittee on Energy and Commerce of the House of Represent14 atives, and post on the Internet website of the Department 

15 of Health and Human Services, a report including, at min16 imum— 

17 ‘‘(1) a description of any new and continuing 

18 grants awarded to entities under subsection (b) and 

19 the specific purpose and amounts of such grants; 

20 ‘‘(2) an overview of— 

21 ‘‘(A) the evaluations conducted under sub22 sections (b) or (f); and 

23 ‘‘(B) technical assistance provided under 

24 subsection (g); and 


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1 ‘‘(3) a description of any significant findings or 

2 developments in patient outcomes and health care 

3 providers and best practices for eligible entities ex4 panding, using, or evaluating technology-enabled col5 laborative learning and capacity building models, in6 cluding through the activities described in subsection 

7 (g). 

8 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There is 

9 authorized to be appropriated to carry out this section, such 

10 sums as may be necessary for each of fiscal years 2020 

11 through 2024.’’. 

12 SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION. 

13 Subtitle C of title XXVIII of the Public Health Service 

14 Act (42 U.S.C. 300hh–31 et seq.) is amended by adding at 

15 the end the following: 

16 ‘‘SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZA17 TION GRANTS. 

18 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

19 Director of the Centers for Disease Control and Prevention, 

20 shall— 

21 ‘‘(1) award grants to State, local, Tribal, and 

22 territorial public health departments for the expan23 sion and modernization of public health data systems, 

24 to assist public health departments in— 


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1 ‘‘(A) assessing current data infrastructure 

2 capabilities and gaps to improve and increase 

3 consistency in data collection, storage, analysis, 

4 and, as appropriate, to improve dissemination of 

5 public health-related information; 

6 ‘‘(B) improving secure public health data 

7 collection, transmission, exchange, maintenance, 

8 and analysis; 

9 ‘‘(C) simplifying and supporting reporting 

10 by health care providers, as applicable, pursuant 

11 to State law, including through the use of health 

12 information technology, to State, local, Tribal, 

13 and territorial public health departments, in14 cluding public health officials in multiple juris15 dictions within such State, as appropriate; 

16 ‘‘(D) enhancing interoperability of public 

17 health data systems (including systems created 

18 or accessed by public health departments) with 

19 health information technology, including health 

20 information technology certified under section 

21 3001(c)(5); 

22 ‘‘(E) supporting earlier disease and health 

23 condition detection, such as through near real24 time data monitoring, to support rapid public 

25 health responses; and 


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1 ‘‘(F) supporting activities within the appli2 cable jurisdiction related to the expansion and 

3 modernization of electronic case reporting; 

4 ‘‘(2) as appropriate, conduct activities related to 

5 the interoperability and improvement of applicable 

6 public health data systems used by the Centers for 

7 Disease Control and Prevention, and, in coordination 

8 with the Office of the National Coordinator for Health 

9 Information Technology, the designation of data and 

10 technology standards for health information systems 

11 of the public health infrastructure with deference 

12 given to standards published by standards develop13 ment organizations and voluntary consensus-based 

14 standards bodies; and 

15 ‘‘(3) develop and utilize public-private partner16 ships for technical assistance and related implementa17 tion support for State, local, Tribal, and territorial 

18 public health departments, and the Centers for Dis19 ease Control and Prevention, on the expansion and 

20 modernization of electronic case reporting and public 

21 health data systems, as applicable. 

22 ‘‘(b) REQUIREMENTS.— 

23 ‘‘(1) IN GENERAL.—The Secretary may not 

24 award a grant under subsection (a)(1) unless the ap25 plicant uses or agrees to use standards recognized by 


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1 the National Coordinator for Health Information 

2 Technology pursuant to section 3001(c)(1) or adopted 

3 by the Secretary under section 3004. 

4 ‘‘(2) WAIVER.—The Secretary may waive the re5 quirement under paragraph (1) with respect to an 

6 applicant if the Secretary determines that the activi7 ties under subsection (a) cannot otherwise be carried 

8 out within the applicable jurisdiction. 

9 ‘‘(3) APPLICATION.—A State, local, Tribal, or 

10 territorial health department applying for a grant 

11 under this section shall submit an application to the 

12 Secretary at such time and in such manner as the 

13 Secretary may require. Such application shall include 

14 information describing— 

15 ‘‘(A) the activities that will be supported by 

16 the grant; and 

17 ‘‘(B) how the modernization of such public 

18 health data systems will support or impact the 

19 public health infrastructure of the health depart20 ment, including a description of remaining gaps, 

21 if any, and the actions needed to address such 

22 gaps. 

23 ‘‘(c) USE OF FUNDS.—An entity receiving a grant 

24 under this section may use amounts received under such 

25 grant for one or both of the following: 


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1 ‘‘(1) Carrying out activities described in sub2 section (a)(1) to support public health data systems 

3 (including electronic case reporting), which may in4 clude support for, and training of, professionals with 

5 expertise in contributing to and using such systems 

6 (including public health data scientists). 

7 ‘‘(2) Developing and disseminating information 

8 related to the use and importance of public health 

9 data. 

10 ‘‘(d) STRATEGY AND IMPLEMENTATION PLAN.—Not 

11 later than 180 days after the date of enactment of the Lower 

12 Health Care Costs Act, the Secretary, acting through the 

13 Director of the Centers for Disease Control and Prevention, 

14 shall submit to the Committee on Health, Education, Labor, 

15 and Pensions of the Senate and the Committee on Energy 

16 and Commerce of the House of Representatives, a coordi17 nated strategy and an accompanying implementation plan 

18 that identifies and demonstrates the steps the Secretary will 

19 carry out to— 

20 ‘‘(1) update and improve applicable public 

21 health data systems used by the Centers for Disease 

22 Control and Prevention; and 

23 ‘‘(2) carry out the activities described in this sec24 tion to support the improvement of State, local, Trib25 al, and territorial public health data systems. 


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1 ‘‘(e) CONSULTATION.—The Secretary, acting through 

2 the Director of the Centers for Disease Control and Preven3 tion, shall consult with State, local, Tribal, and territorial 

4 health departments, professional medical and public health 

5 associations, associations representing hospitals or other 

6 health care entities, health information technology experts, 

7 and other appropriate entities regarding the plan and 

8 grant program to modernize public health data systems 

9 pursuant to this section. Such activities may include the 

10 provision of technical assistance related to the exchange of 

11 information by such public health data systems used by rel12 evant health care and public health entities at the local, 

13 State, Federal, Tribal, and territorial levels. 

14 ‘‘(f) REPORT TO CONGRESS.—Not later than 1 year 

15 after the date of enactment of this section, the Secretary 

16 shall submit a report to the Committee on Health, Edu17 cation, Labor, and Pensions of the Senate and the Com18 mittee on Energy and Commerce of the House of Represent19 atives that includes— 

20 ‘‘(1) a description of any barriers to— 

21 ‘‘(A) public health authorities implementing 

22 interoperable public health data systems and 

23 electronic case reporting; 

24 ‘‘(B) the exchange of information pursuant 

25 to electronic case reporting; or 


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1 ‘‘(C) reporting by health care providers 

2 using such public health data systems, as appro3 priate, and pursuant to State law; 

4 ‘‘(2) an assessment of the potential public health 

5 impact of implementing electronic case reporting and 

6 interoperable public health data systems; and 

7 ‘‘(3) a description of the activities carried out 

8 pursuant to this section. 

9 ‘‘(g) ELECTRONIC CASE REPORTING.—In this section, 

10 the term ‘electronic case reporting’ means the automated 

11 identification, generation, and bilateral exchange of reports 

12 of health events among electronic health record or health 

13 information technology systems and public health authori14 ties. 

15 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 

16 purpose of carrying out this section, there are authorized 

17 to be appropriated such sums as may be necessary for fiscal 

18 years 2020 through 2024.’’. 

19 SEC. 406. INNOVATION FOR MATERNAL HEALTH. 

20 Title III of the Public Health Service Act is amended 

21 by inserting after section 330N of such Act, as added by 

22 section 404, the following: 

23 ‘‘SEC. 330O. INNOVATION FOR MATERNAL HEALTH. 

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

25 with experts representing a variety of clinical specialties, 


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1 State, tribal, or local public health officials, researchers, 

2 epidemiologists, statisticians, and community organiza3 tions, shall establish or continue a program to award com4 petitive grants to eligible entities for the purpose of— 

5 ‘‘(1) identifying, developing, or disseminating 

6 best practices to improve maternal health care quality 

7 and outcomes, eliminate preventable maternal mor8 tality and severe maternal morbidity, and improve 

9 infant health outcomes, which may include— 

10 ‘‘(A) information on evidence-based prac11 tices to improve the quality and safety of mater12 nal health care in hospitals and other health care 

13 settings of a State or health care system, includ14 ing by addressing topics commonly associated 

15 with health complications or risks related to pre16 natal care, labor care, birthing, and postpartum 

17 care; 

18 ‘‘(B) best practices for improving maternal 

19 health care based on data findings and reviews 

20 conducted by a State maternal mortality review 

21 committee that address topics of relevance to 

22 common complications or health risks related to 

23 prenatal care, labor care, birthing, and 

24 postpartum 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 pre9 ventable 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; and 

15 ‘‘(4) identifying, developing, and evaluating new 

16 models of care that improve maternal and infant 

17 health outcomes, which may include the integration of 

18 community-based services and clinical care. 

19 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible for a grant 

20 under subsection (a), an entity shall— 

21 ‘‘(1) submit to the Secretary an application at 

22 such time, in such manner, and containing such in23 formation as the Secretary may require; and 

24 ‘‘(2) demonstrate in such application that the 

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1 nal safety and quality improvement initiatives in the 

2 areas of obstetrics and gynecology or maternal health. 

3 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 

4 out this section, there is authorized to be appropriated such 

5 sums as may be necessary for each of fiscal years 2020 

6 through 2024.’’. 

7 SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS. 

8 Title VII of the Public Health Service Act is amended 

9 by striking section 763 (42 U.S.C. 294p) and inserting the 

10 following: 

11 ‘‘SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS. 

12 ‘‘(a) GRANT PROGRAM.—The Secretary shall establish 

13 a program to award grants to accredited schools of 

14 allopathic medicine, osteopathic medicine, and nursing, 

15 and other health professional training programs for the 

16 training of health care professionals to reduce and prevent 

17 discrimination (including training related to implicit bi18 ases) in the provision of health care services related to pre19 natal care, labor care, birthing, and postpartum care. 

20 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

21 subsection (a), an entity described in such subsection shall 

22 submit to the Secretary an application at such time, in 

23 such manner, and containing such information as the Sec24 retary may require. 


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1 ‘‘(c) REPORTING REQUIREMENT.—Each entity award2 ed a grant under this section shall periodically submit to 

3 the Secretary a report on the status of activities conducted 

4 using the grant, including a description of the impact of 

5 such training on patient outcomes, as applicable. 

6 ‘‘(d) BEST PRACTICES.—The Secretary may identify 

7 and disseminate best practices for the training of health 

8 care professionals to reduce and prevent discrimination (in9 cluding training related to implicit biases) in the provision 

10 of health care services related to prenatal care, labor care, 

11 birthing, and postpartum care. 

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

13 out this section, there is authorized to be appropriated such 

14 sums as may be necessary for each of fiscal years 2020 

15 through 2024.’’. 

16 SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT 

17 DISCRIMINATION. 

18 Not later than 2 years after date of enactment of this 

19 Act, the Secretary of Health and Human Services (referred 

20 to in this section as the ‘‘Secretary’’) shall, through a con21 tract with an independent research organization, conduct 

22 a study and make recommendations for accredited schools 

23 of allopathic medicine, osteopathic medicine, and nursing, 

24 and other health professional training programs on best 

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1 crimination, including training related to implicit biases, 

2 in the provision of health care services related to prenatal 

3 care, labor care, birthing, and postpartum care. 

4 SEC. 409. PERINATAL QUALITY COLLABORATIVES. 

5 Section 317K(a)(2) of the Public Health Service Act 

6 (42 U.S.C. 247b–12(a)(2)) is amended by adding at the end 

7 the following: 

8 ‘‘(E)(i) The Secretary, acting through the 

9 Director of the Centers for Disease Control and 

10 Prevention and in coordination with other offices 

11 and agencies, as appropriate, shall establish or 

12 continue a competitive grant program for the es13 tablishment or support of perinatal quality 

14 collaboratives to improve perinatal care and 

15 perinatal health outcomes for pregnant and 

16 postpartum women and their infants. A State, 

17 Indian Tribe, or Tribal organization may use 

18 funds received through such grant to— 

19 ‘‘(I) support the use of evidence-based 

20 or evidence-informed practices to improve 

21 outcomes for maternal and infant health; 

22 ‘‘(II) work with clinical teams; experts; 

23 State, local, and, as appropriate, tribal 

24 public health officials; and stakeholders, in25 cluding patients and families, to identify, 


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1 develop, or disseminate best practices to im2 prove perinatal care and outcomes; and 

3 ‘‘(III) employ strategies that provide 

4 opportunities for health care professionals 

5 and clinical teams to collaborate across 

6 health care settings and disciplines, includ7 ing primary care and mental health, as ap8 propriate, to improve maternal and infant 

9 health outcomes, which may include the use 

10 of data to provide timely feedback across 

11 hospital and clinical teams to inform re12 sponses, and to provide support and train13 ing to hospital and clinical teams for qual14 ity improvement, as appropriate. 

15 ‘‘(ii) To be eligible for a grant under clause 

16 (i), an entity shall submit to the Secretary an 

17 application in such form and manner and con18 taining such information as the Secretary may 

19 require.’’. 

20 SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND 

21 POSTPARTUM WOMEN. 

22 (a) GRANTS.—Title III of the Public Health Service 

23 Act is amended by inserting after section 330O of such Act, 

24 as added by section 406, the following: 


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1 ‘‘SEC. 330P. INTEGRATED SERVICES FOR PREGNANT AND 

2 POSTPARTUM WOMEN. 

3 ‘‘(a) IN GENERAL.—The Secretary may award grants 

4 for the purpose of establishing or operating evidence-based 

5 or innovative, evidence-informed programs to deliver inte6 grated health care services to pregnant and postpartum 

7 women to optimize the health of women and their infants, 

8 including to reduce adverse maternal health outcomes, preg9 nancy-related deaths, and related health disparities (includ10 ing such disparities associated with racial and ethnic mi11 nority populations), and, as appropriate, by addressing 

12 issues researched under subsection (b)(2) of section 317K. 

13 ‘‘(b) INTEGRATED SERVICES FOR PREGNANT AND

14 POSTPARTUM WOMEN.— 

15 ‘‘(1) ELIGIBILITY.—To be eligible to receive a 

16 grant under subsection (a), a State, Indian Tribe, or 

17 Tribal organization (as such terms are defined in sec18 tion 4 of the Indian Self-Determination and Edu19 cation Assistance Act) shall work with relevant stake20 holders that coordinate care (including coordinating 

21 resources and referrals for health care and social serv22 ices) to develop and carry out the program, includ23 ing— 

24 ‘‘(A) State, Tribal, and local agencies re25 sponsible for Medicaid, public health, social servVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00414 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 ices, mental health, and substance use disorder 

2 treatment and services; 

3 ‘‘(B) health care providers who serve preg4 nant and postpartum women; and 

5 ‘‘(C) community-based health organizations 

6 and health workers, including providers of home 

7 visiting services and individuals representing 

8 communities with disproportionately high rates 

9 of maternal mortality and severe maternal mor10 bidity, and including those representing racial 

11 and ethnicity minority populations. 

12 ‘‘(2) TERMS.— 

13 ‘‘(A) PERIOD.—A grant awarded under 

14 subsection (a) shall be made for a period of 5 

15 years. Any supplemental award made to a 

16 grantee under subsection (a) may be made for a 

17 period of less than 5 years. 

18 ‘‘(B) PREFERENCE.—In awarding grants 

19 under subsection (a), the Secretary shall— 

20 ‘‘(i) give preference to States, Indian 

21 Tribes, and Tribal organizations that have 

22 the highest rates of maternal mortality and 

23 severe maternal morbidity relative to other 

24 such States, Indian Tribes, or Tribal orga25 nizations, respectively; and 


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1 ‘‘(ii) shall consider health disparities 

2 related to maternal mortality and severe 

3 maternal morbidity, including such dispari4 ties associated with racial and ethnic mi5 nority populations. 

6 ‘‘(C) PRIORITY.—In awarding grants under 

7 subsection (a), the Secretary shall give priority 

8 to applications from up to 15 entities described 

9 in subparagraph (B)(i). 

10 ‘‘(D) EVALUATION.—The Secretary shall re11 quire grantees to evaluate the outcomes of the 

12 programs supported under the grant. 

13 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There are 

14 authorized to be appropriated to carry out this section such 

15 sums as may be necessary for each of fiscal years 2020 

16 through 2024.’’. 

17 (b) REPORT ON GRANT OUTCOMES AND DISSEMINA18 TION OF BEST PRACTICES.— 

19 (1) REPORT.—Not later than February 1, 2026, 

20 the Secretary of Health and Human Services shall 

21 submit to the Committee on Health, Education, 

22 Labor, and Pensions of the Senate and the Committee 

23 on Energy and Commerce of the House of Representa24 tives a report that describes— 


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1 (A) the outcomes of the activities supported 

2 by the grants awarded under the amendments 

3 made by this section on maternal and child 

4 health; 

5 (B) best practices and models of care used 

6 by recipients of grants under such amendments; 

7 and 

8 (C) obstacles identified by recipients of 

9 grants under such amendments, and strategies 

10 used by such recipients to deliver care, improve 

11 maternal and child health, and reduce health 

12 disparities. 

13 (2) DISSEMINATION OF BEST PRACTICES.—Not 

14 later than August 1, 2026, the Secretary of Health 

15 and Human Services shall disseminate information 

16 on best practices and models of care used by recipi17 ents of grants under the amendments made by this 

18 section (including best practices and models of care 

19 relating to the reduction of health disparities, includ20 ing such disparities associated with racial and ethnic 

21 minority populations, in rates of maternal mortality 

22 and severe maternal morbidity) to relevant stake23 holders, which may include health providers, medical 

24 schools, nursing schools, relevant State, tribal, and 

25 local agencies, and the general public. 


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1 SEC. 411. EXTENSION FOR COMMUNITY HEALTH CENTERS, 

2 THE NATIONAL HEALTH SERVICE CORPS, AND 

3 TEACHING HEALTH CENTERS THAT OPERATE 

4 GME PROGRAMS. 

5 (a) COMMUNITY HEALTH CENTERS.—Section 

6 10503(b)(1)(F) of the Patient Protection and Affordable 

7 Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended by strik8 ing ‘‘fiscal year 2019’’ and inserting ‘‘each of fiscal years 

9 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 strik13 ing ‘‘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 insert18 ing ‘‘through 2024’’. 

19 (d) APPLICATION OF PROVISIONS.—Amounts appro20 priated pursuant to this section for each of fiscal years 2019 

21 through 2024 shall be subject to the requirements contained 

22 in Public Law 115–245 for funds for programs authorized 

23 under sections 330 through 340 of the Public Health Service 

24 Act. 

25 (e) CONFORMING AMENDMENTS.—Paragraph (4) of 

26 section 3014(h) of title 18, United States Code, as amended 


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1 by section 50901 of Public Law 115–123, is amended by 

2 striking ‘‘and section 50901(e) of the Advancing Chronic 

3 Care, Extenders, and Social Services Act’’ and inserting ‘‘, 

4 section 50901(e) of the Advancing Chronic Care, Extenders, 

5 and Social Services Act, and section 411(d) of the Lower 

6 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 amended 

10 by striking ‘‘and 2019’’ and inserting ‘‘through 2024’’. 

11 (b) INDIANS.—Subparagraph (D) of section 330C(c)(2) 

12 of the Public Health Service Act (42 U.S.C. 254c– 

13 3(c)(2)(D)) is amended by striking ‘‘and 2019’’ and insert14 ing ‘‘through 2024’’. 

15 SEC. 413. NATIVE AMERICAN SUICIDE PREVENTION. 

16 Section 520E(b) of the Public Health Service Act (42 

17 U.S.C. 290bb–36(b) is amended by inserting after para18 graph (3) the following: 

19 ‘‘(4) CONSULTATION.—A State applying for a 

20 grant or cooperative agreement under this section 

21 shall, in the development and implementation of a 

22 statewide early intervention strategy, consult or con23 fer with entities described in paragraph (1)(C) in 

24 such State.’’. 


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1 SEC. 414. MINIMUM AGE OF SALE OF TOBACCO PRODUCTS. 

2 (a) IN GENERAL.—Section 906(d) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is amended— 

4 (1) in paragraph (3)(A)(ii), by striking ‘‘18 

5 years’’ and inserting ‘‘21 years’’; and 

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

7 ‘‘(5) MINIMUM AGE OF SALE.—It shall be unlaw8 ful for any retailer to sell a tobacco product to any 

9 person younger than 21 years of age.’’. 

10 (b) REGULATIONS.—Not later than 180 days after the 

11 date of enactment of this Act, the Secretary of Health and 

12 Human Services (referred to in this section as the ‘‘Sec13 retary’’) shall publish in the Federal Register a final rule 

14 to update the regulations issued under chapter IX of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et 

16 seq.) as appropriate, only to carry out the amendments 

17 made by subsection (a), including updating the relevant age 

18 verification requirements under part 1140 of title 21, Code 

19 of Federal Regulations to require age verification for indi20 viduals under the age of 30. Such final rule shall— 

21 (1) take full effect not later than 90 days after 

22 the date on which such final rule is published; and 

23 (2) be deemed to be in compliance with all appli24 cable provisions of chapter 5 of title 5, United States 

25 Code and all other provisions of law relating to rule26 making procedures. 


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1 (c) NOTIFICATION.—Not later than 90 days after the 

2 date of enactment of this Act, the Secretary shall provide 

3 written notification to the Committee on Health, Edu4 cation, Labor, and Pensions of the Senate and the Com5 mittee on Energy and Commerce of the House of Represent6 atives regarding the progress of the Department of Health 

7 and Human Services towards promulgating the final rule 

8 under subsection (b). If, 180 days after the date of enact9 ment of this Act, such rule has not been promulgated in 

10 accordance with subsection (b), the Secretary shall provide 

11 a written notification and a justification for the delay in 

12 rulemaking to such committees. 

13 (d) PENALTIES FOR VIOLATIONS.— 

14 (1) IN GENERAL.—Section 103(q)(2) of the Fam15 ily Smoking Prevention and Tobacco Control Act 

16 (Public Law 111–31) is amended— 

17 (A) in subparagraph (A), in the matter pre18 ceding clause (i), by inserting ‘‘section 906(d)(5) 

19 or of’’ after ‘‘violations of’’; and 

20 (B) in subparagraph (C), by inserting ‘‘sec21 tion 906(d)(5) or of’’ after ‘‘a retailer of’’. 

22 (2) REPEATED VIOLATIONS.—Section 303(f)(8) 

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

24 U.S.C. 333(f)(8)) is amended by inserting ‘‘section 

25 906(d)(5) or of’’ after ‘‘repeated violations of’’. 


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1 (3) MISBRANDED PRODUCTS.—Section 

2 903(a)(7)(B) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 387c) is amended by inserting ‘‘sec4 tion 906(d)(5) or of’’ after ‘‘violation of’’. 

5 SEC. 415. SALE OF TOBACCO PRODUCTS TO INDIVIDUALS 

6 UNDER THE AGE OF 21. 

7 (a) IN GENERAL.—Section 1926 of the Public Health 

8 Service Act (42 U.S.C. 300x–26) is amended— 

9 (1) in the heading— 

10 (A) by striking ‘‘STATE LAW REGARD11 ING’’; and 

12 (B) by striking ‘‘18’’ and inserting ‘‘21’’; 

13 (2) by striking subsections (a) and (d); 

14 (3) by redesignating subsections (b) and (c) as 

15 subsections (a) and (b), respectively; 

16 (4) by amending subsection (a), as so redesig17 nated, to read as follows: 

18 ‘‘(a) IN GENERAL.—A funding agreement for a grant 

19 under section 1921 is that the State involved will— 

20 ‘‘(1) annually conduct random, unannounced in21 spections to ensure that retailers do not sell tobacco 

22 products to individuals under the age of 21; and 

23 ‘‘(2) annually submit to the Secretary a report 

24 describing— 


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1 ‘‘(A) the activities carried out by the State 

2 to ensure that retailers do not sell tobacco prod3 ucts to individuals under the age of 21; 

4 ‘‘(B) the extent of success the State has 

5 achieved in ensuring that retailers do not sell to6 bacco products to individuals under the age of 

7 21; and 

8 ‘‘(C) the strategies to be utilized by the 

9 State to ensure that retailers do not sell tobacco 

10 products to individuals under the age of 21 dur11 ing the fiscal year for which the grant is 

12 sought.’’; 

13 (5) in subsection (b), as so redesignated— 

14 (A) by striking paragraphs (1), (2), (3), 

15 and (4); 

16 (B) by striking ‘‘Before making’’ and in17 serting the following: 

18 ‘‘(1) IN GENERAL.—Before making’’; 

19 (C) by striking ‘‘for the first applicable fis20 cal year or any subsequent fiscal year’’; 

21 (D) by striking ‘‘subsections (a) and (b)’’ 

22 and inserting ‘‘subsection (a)’’; 

23 (E) by striking ‘‘equal to—’’ and inserting 

24 ‘‘up to 10 percent of the amount determined 


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1 under section 1933 for the State for the applica2 ble fiscal year.’’; and 

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

4 ‘‘(2) LIMITATION.— 

5 ‘‘(A) IN GENERAL.—A State shall not have 

6 funds withheld pursuant to paragraph (1) if 

7 such State for which the Secretary has made a 

8 determination of noncompliance under such 

9 paragraph— 

10 ‘‘(i) certifies to the Secretary by May 

11 1 of the fiscal year for which the funds are 

12 appropriated, consistent with subparagraph 

13 (B), that the State will commit additional 

14 State funds, in accordance with paragraph 

15 (1), to ensure that retailers do not sell to16 bacco products to individuals under 21 

17 years of age; 

18 ‘‘(ii) agrees to comply with a nego19 tiated agreement for a corrective action 

20 plan that is approved by the Secretary and 

21 carried out in accordance with guidelines 

22 issued by the Secretary; or 

23 ‘‘(iii) is a territory that receives less 

24 than $1,000,000 for a fiscal year under sec25 tion 1921. 


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1 ‘‘(B) CERTIFICATION.— 

2 ‘‘(i) IN GENERAL.—The amount of 

3 funds to be committed by a State pursuant 

4 to subparagraph (A)(i) shall be equal to 1 

5 percent of such State’s substance abuse allo6 cation determined under section 1933 for 

7 each percentage point by which the State 

8 misses the retailer compliance rate goal es9 tablished by the Secretary. 

10 ‘‘(ii) STATE EXPENDITURES.—For a 

11 fiscal year in which a State commits funds 

12 as described in clause (i), such State shall 

13 maintain State expenditures for tobacco 

14 prevention programs and for compliance ac15 tivities at a level that is not less than the 

16 level of such expenditures maintained by the 

17 State for the preceding fiscal year, plus the 

18 additional funds for tobacco compliance ac19 tivities required under clause (i). The State 

20 shall submit a report to the Secretary on all 

21 State obligations of funds for such fiscal 

22 year and all State expenditures for the pre23 ceding fiscal year for tobacco prevention 

24 and compliance activities by program activ25 ity by July 31 of such fiscal year. 


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1 ‘‘(iii) DISCRETION.—The Secretary 

2 shall exercise discretion in enforcing the 

3 timing of the State obligation of the addi4 tional funds required by the certification 

5 described in subparagraph (A)(i) as late as 

6 July 31 of such fiscal year. 

7 ‘‘(C) FAILURE TO CERTIFY.—If a State de8 scribed in subparagraph (A) fails to certify to 

9 the Secretary pursuant to subparagraph (A)(i) 

10 or enter into, or comply with, a negotiated agree11 ment under subparagraph (A)(ii), the Secretary 

12 may take action pursuant to paragraph (1).’’; 

13 and 

14 (6) by adding at the end the following: 

15 ‘‘(c) IMPLEMENTATION OF REPORTING REQUIRE16 MENTS.— 

17 ‘‘(1) TRANSITION PERIOD.—The Secretary 

18 shall— 

19 ‘‘(A) not withhold amounts under subsection 

20 (b) for the 3-year period immediately following 

21 the date of enactment of the Lower Health Care 

22 Costs Act; and 

23 ‘‘(B) use discretion in exercising its author24 ity under subsection (b) during the 2-year period 

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1 scribed in subparagraph (A), to allow for a tran2 sition period for implementation of the reporting 

3 requirements under subsection (a)(2). 

4 ‘‘(2) REGULATIONS OR GUIDANCE.—Not later 

5 than 180 days after the date of enactment of the 

6 Lower Health Care Costs Act the Secretary shall up7 date regulations under part 96 of title 45, Code of 

8 Federal Regulations or guidance on the retailer com9 pliance rate goal under subsection (b), the use of 

10 funds provided under section 1921 for purposes of 

11 meeting the requirements of this section, and report12 ing requirements under subsection (a)(2). 

13 ‘‘(3) COORDINATION.—The Secretary shall ensure 

14 the Assistant Secretary for Mental Health and Sub15 stance Use coordinates, as appropriate, with the Com16 missioner of Food and Drugs in providing technical 

17 assistance under this section to States, related to en18 suring retailers do not sell tobacco products to indi19 viduals under the age of 21, that is consistent with 

20 applicable regulations issued by the Food and Drug 

21 Administration. 

22 ‘‘(d) TRANSITIONAL GRANTS.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall award 

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1 ceives funding under section 1921 to ensure compli2 ance of each such State with this section. 

3 ‘‘(2) USE OF FUNDS.—A State receiving a grant 

4 under this subsection— 

5 ‘‘(A) shall use amounts received under such 

6 grant for activities to plan for or ensure compli7 ance in the State with subsection (a); and 

8 ‘‘(B) in the case of a State for which the 

9 Secretary has made a determination under sub10 section (b) that the State is prepared to meet, or 

11 has met, the requirements of subsection (a), may 

12 use such funds for tobacco cessation activities, 

13 strategies to prevent the use of tobacco products 

14 by individuals under the age of 21, or allowable 

15 uses under section 1921. 

16 ‘‘(3) SUPPLEMENT NOT SUPPLANT.—Grants 

17 under this subsection shall be used to supplement and 

18 not supplant other Federal, State, and local public 

19 funds provided for activities under paragraph (2). 

20 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—To 

21 carry out this subsection, there are authorized to be 

22 appropriated $18,580,790 for each of fiscal years 

23 2020 through 2024. 

24 ‘‘(5) SUNSET.—This subsection shall have no 

25 force or effect after September 30, 2024. 


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1 ‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall 

2 provide technical assistance to States related to the activi3 ties required under this section.’’. 

4 (b) REPORT TO CONGRESS.—Not later than 3 years 

5 after the date of enactment of this Act, the Secretary shall 

6 submit to the Committee on Health, Education, Labor, and 

7 Pensions of the Senate and the Committee on Energy and 

8 Commerce of the House of Representatives a report on the 

9 status of implementing the requirements of section 1926 of 

10 the Public Health Service Act (42 U.S.C. 300x–26), as 

11 amended by subsection (a), and a description of any tech12 nical assistance provided under subsection (e) of such sec13 tion, including the number of meetings requested and held 

14 related to technical assistance. 

15 (c) CONFORMING AMENDMENT.—Section 212 of divi16 sion D of the Consolidated Appropriations Act, 2010 (Pub17 lic Law 111–117) is repealed. 

18 TITLE V—IMPROVING THE EX19 CHANGE OF HEALTH INFOR20 MATION 

21 SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, 

22 NETWORK, AND COST INFORMATION. 

23 (a) IN GENERAL.—Part A of title XXVII of the Public 

24 Health Service Act (42 U.S.C. 300gg et seq.) is amended 

25 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, and 

6 use without special effort, through application program7 ming interfaces (or successor technology or standards), the 

8 information described in subsection (b), in the manner de9 scribed in subsection (b) and otherwise consistent with this 

10 section. 

11 ‘‘(b) INFORMATION.—The following information is re12 quired to be made available, as the Secretary may specify: 

13 ‘‘(1) Historical claims, provider encounter, and 

14 payment data for each enrollee, which shall— 

15 ‘‘(A) include adjudicated medical and pre16 scription drug claims and equivalent encounters, 

17 including all data elements contained in such 

18 transactions— 

19 ‘‘(i) that were adjudicated by the group 

20 health plan or health insurance issuer dur21 ing the previous 5 years or the enrollee’s en22 tire period of enrollment in the applicable 

23 plan or coverage if such period is less than 

24 the previous 5 years; 

25 ‘‘(ii) that involve benefits managed by 

26 any third party, such as a pharmacy beneVerDate Sep 11 2014 23:21 Jul 08, 2019 Jkt 089200 PO 00000 Frm 00430 Fmt 6652 Sfmt 6203 E:\BILLS\S1895.RS S1895

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1 fits manager or radiology benefits manager 

2 that manages benefits or adjudicates claims 

3 on behalf of the plan or coverage; and 

4 ‘‘(iii) from any other health plan or 

5 health insurance coverage offered by the 

6 same insurance issuer, in which the same 

7 enrollee was enrolled during the previous 5 

8 years; and 

9 ‘‘(B) be available to an enrollee or former 

10 enrollee, the enrollee’s providers, and any third11 party applications or services authorized by the 

12 enrollee— 

13 ‘‘(i) through the application program14 ming interfaces (or successor technology or 

15 standards) as required by this paragraph, 

16 in a single, longitudinal format that is easy 

17 to understand, secure, and that may update 

18 automatically; 

19 ‘‘(ii) as soon as practicable, and in no 

20 case later than the period of time deter21 mined by the Secretary, after the claim is 

22 adjudicated or the data is received by the 

23 health plan or health insurance issuer; and 

24 ‘‘(iii) to the enrollee, former enrollee, 

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1 tions or services authorized by the enrollee, 

2 for 5 years after the end date of the enroll3 ee’s enrollment in the plan or in any cov4 erage offered by the health insurance issuer. 

5 ‘‘(2) Identifying directory information for all in6 network providers, including facilities and practi7 tioners, that participate in the plan or coverage, 

8 which shall— 

9 ‘‘(A) include— 

10 ‘‘(i) the national provider identifier for 

11 in-network facilities and practitioners; and 

12 ‘‘(ii) the name, address, phone number, 

13 and specialty for each such facility and 

14 practitioner, based on the most recent inter15 action between the plan or coverage and 

16 that facility or practitioner; 

17 ‘‘(B) be capable of returning the informa18 tion necessary to establish a list of participating 

19 in-network facilities and practitioners, in a 

20 given specialty or at a particular facility type, 

21 within a specified geographic radius; and 

22 ‘‘(C) be capable of returning the network 

23 status, when presented with identifiers for a 

24 given enrollee and facility or practitioner. 


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1 ‘‘(3) Estimated enrollee out-of-pocket costs, in2 cluding costs expected to be incurred through a de3 ductible, co-payment, coinsurance, or other form of 

4 cost-sharing, for— 

5 ‘‘(A) a designated set of common services or 

6 episodes of care, to be established by the Sec7 retary through rulemaking, including, at a min8 imum— 

9 ‘‘(i) in the case of services provided by 

10 a hospital, the 100 most common diagnosis11 related groups, as used in the Medicare In12 patient Prospective Patient System (or suc13 cessor episode-based reimbursement method14 ology) at that hospital, based on claims 

15 data adjudicated by the group health plan 

16 or health insurance issuer; 

17 ‘‘(ii) in the case of services provided in 

18 an out-patient setting, including radiology, 

19 lab tests, and out-patient surgical proce20 dures, any service rendered by the facility 

21 or practitioner, and reimbursed by the 

22 health plan or health insurance issuer; and 

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1 ties, and long-term care hospitals, the pa2 tient out-of-pocket costs for an episode of 

3 care, as the Secretary may determine, which 

4 permits users to reasonably compare costs 

5 across different facility and service types; 

6 and 

7 ‘‘(B) all prescription drugs currently in8 cluded on any tier of the formulary of the plan 

9 or coverage. 

10 ‘‘(4) A list of the categories of providers of ancil11 lary services, as defined in section 2719(A)(i)(3), for 

12 which the plan or coverage has no in-network pro13 viders. 

14 ‘‘(c) AVAILABILITY AND ACCESS.—Subject to all appli15 cable Federal and State privacy, security, and breach noti16 fication laws, the application programming interfaces, in17 cluding all data required to be made available through such 

18 interfaces, shall— 

19 ‘‘(1) be made available by the applicable group 

20 health plan or health insurance issuer, at no charge, 

21 to— 

22 ‘‘(A) enrollees and prospective enrollees in 

23 the group health plan or health insurance cov24 erage; 


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1 ‘‘(B) third parties authorized by the en2 rollee; 

3 ‘‘(C) facilities and practitioners who are 

4 under contract with the plan or coverage; and 

5 ‘‘(D) business associates of such facilities 

6 and practitioners, as defined in section 160.103 

7 of title 45, Code of Federal Regulations (or any 

8 successor regulations); 

9 ‘‘(2) be available to enrollees in the group health 

10 plan or health insurance coverage, and to third-party 

11 applications or services facilitating such access by en12 rollees, during the enrollment process and for a min13 imum of 5 years after the end date of the enrollee’s 

14 enrollment in the plan or in any coverage offered by 

15 the health insurance issuer; 

16 ‘‘(3) permit persistent access by third party ap17 plications or services authorized by the enrollee, for a 

18 reasonable period of time, consistent with the require19 ments of the HIPAA Security rule (part 160 of title 

20 45 Code of Federal Regulations and subparts A and 

21 C of part 164 of such title); 

22 ‘‘(4) employ the applicable content, vocabulary, 

23 and technical standards, as determined by the Sec24 retary pursuant to title XXX; and 


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1 ‘‘(5) employ security and authentication stand2 ards, as the Secretary determines appropriate. 

3 ‘‘(d) RULE OF CONSTRUCTION REGARDING PRIVACY.— 

4 Nothing in this section shall be construed to alter existing 

5 obligations of a covered entity or business associate under 

6 the privacy, security, and breach notification rules promul7 gated under section 264(c) of the Health Insurance Port8 ability and Accountability Act or section 13402 of the 

9 HITECH Act, or to alter the Secretary’s existing authority 

10 to modify such rules, under part 2 of title 42, Code of Fed11 eral Regulations (or successor regulations), under section 

12 444 of the General Education Provisions Act (20 U.S.C. 

13 1232g) (commonly referred to as the ‘Family Educational 

14 Rights and Privacy Act of 1974’), under the amendments 

15 made by the Genetic Information Nondiscrimination Act, 

16 or under State privacy law.’’. 

17 (b) EFFECTIVE DATE.—Section 2715B of the Public 

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

19 effect 18 months after the date of enactment of this Act. 

20 SEC. 502. RECOGNITION OF SECURITY PRACTICES. 

21 Part 1 of subtitle D of the Health Information Tech22 nology for Economic and Clinical Health Act (42 U.S.C. 

23 17931 et seq.) is amended by adding at the end the fol24 lowing: 


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1 ‘‘SEC. 13412. RECOGNITION OF SECURITY PRACTICES. 

2 ‘‘(a) IN GENERAL.—Consistent with the authority of 

3 the Secretary under sections 1176 and 1177 of the Social 

4 Security Act, when making determinations relating to fines 

5 under section 13410, decreasing the length and extent of an 

6 audit under section 13411, or remedies otherwise agreed to 

7 by the Secretary, the Secretary shall consider whether the 

8 covered entity or business associate has adequately dem9 onstrated that it had, for not less than the previous 12 

10 months, recognized security practices in place that may— 

11 ‘‘(1) mitigate fines under section 13410; 

12 ‘‘(2) result in the early, favorable termination of 

13 an audit under section 13411; and 

14 ‘‘(3) mitigate the remedies that would otherwise 

15 be agreed to in any agreement with respect to resolv16 ing potential violations of the HIPAA Security rule 

17 (part 160 of title 45 Code of Federal Regulations and 

18 subparts A and C of part 164 of such title) between 

19 the covered entity or business associate and the De20 partment of Health and Human Services. 

21 ‘‘(b) DEFINITION AND MISCELLANEOUS PROVISIONS.— 

22 ‘‘(1) RECOGNIZED SECURITY PRACTICES.—The 

23 term ‘recognized security practices’ means the stand24 ards, guidelines, best practices, methodologies, proce25 dures, and processes developed under section 2(c)(15) 

26 of the National Institute of Standards and Technology 


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1 Act, the approaches promulgated under section 405(d) 

2 of the Cybersecurity Act of 2015, and other programs 

3 and processes that address cybersecurity and that are 

4 developed, recognized, or promulgated through regula5 tions under other statutory authorities. Such practices 

6 shall be determined by the covered entity or business 

7 associate. 

8 ‘‘(2) LIMITATION.—Nothing in this section shall 

9 be construed as providing the Secretary authority to 

10 increase fines under section 13410, or the length, ex11 tent or quantity of audits under section 13411, due 

12 to a lack of compliance with the recognized security 

13 practices. 

14 ‘‘(3) NO LIABILITY FOR NONPARTICIPATION.— 

15 Subject to paragraph (4), nothing in this section shall 

16 be construed to subject a covered entity or business as17 sociate to liability for electing not to engage in the 

18 recognized security practices defined by this section. 

19 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

20 section shall be construed to limit the Secretary’s au21 thority to enforce the HIPAA Security rule (part 160 

22 of title 45 Code of Federal Regulations and subparts 

23 A and C of part 164 of such title), or to supersede 

24 or conflict with an entity or business associate’s obli25 gations under the HIPAA 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 date 

8 of enactment of this Act, the Comptroller General of the 

9 United States shall conduct a study to— 

10 (1) describe the roles of Federal agencies and the 

11 private sector with respect to protecting the privacy 

12 and security of individually identifiable health infor13 mation transmitted electronically to and from entities 

14 not covered by the regulations promulgated under sec15 tion 264(c) of the Health Insurance Portability and 

16 Accountability Act of 1996 (42 U.S.C. 1320d–2 note); 

17 (2) identify recent developments regarding the 

18 use of application programming interfaces to access 

19 individually identifiable health information, and im20 plications for the privacy and security of such infor21 mation; 

22 (3) identify practices in the private sector, such 

23 as terms and conditions for use, relating to the pri24 vacy, disclosure, and secondary uses of individually 

25 identifiable health information transmitted electroni26 cally to or from entities, selected by an individual, 


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1 that are not subject to the regulations promulgated 

2 under section 264(c) of the Health Insurance Port3 ability and Accountability Act of 1996; and 

4 (4) identify steps the public and private sectors 

5 can take to improve the private and secure access to 

6 and availability of individually identifiable health 

7 information. 

8 (b) REPORT.—Not later than 1 year after the date of 

9 enactment of this Act, the Comptroller General of the United 

10 States shall submit to Congress a report concerning the 

11 findings of the study conducted under subsection (a). 

12 SEC. 504. TECHNICAL CORRECTIONS. 

13 (a) IN GENERAL.—Section 3022(b) of the Public 

14 Health Service Act (42 U.S.C. 300jj–52(b)) is amended by 

15 adding at the end the following new paragraph: 

16 ‘‘(4) APPLICATION OF AUTHORITIES UNDER IN17 SPECTOR GENERAL ACT OF 1978.—In carrying out 

18 this subsection, the Inspector General shall have the 

19 same authorities as provided under section 6 of the 

20 Inspector General Act of 1978 (5 U.S.C. App.).’’. 

21 (b) EFFECTIVE DATE.—The amendment made by sub22 section (a) shall take effect as if included in the enactment 

23 of the 21st Century Cures Act (Public Law 114–255). 


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1 SEC. 505. PUBLIC MEETING. 

2 (a) IN GENERAL.—Not later than 180 days after the 

3 date of enactment of this Act, the Secretary of Health and 

4 Human Services shall convene a public meeting for pur5 poses of discussing and providing input on patient-match6 ing metrics for the purpose of enabling interoperability and 

7 the exchange of health information across health care orga8 nizations. 

9 (b) EXPERTS.—The public meeting under this section 

10 may include— 

11 (1) representatives of relevant Federal agencies 

12 (including representatives from the Office of the Na13 tional Coordinator for Health Information Tech14 nology); 

15 (2) State, local, Tribal, and territorial public 

16 health officials; 

17 (3) stakeholders with expertise in health informa18 tion exchange; 

19 (4) stakeholders with expertise in capabilities 

20 relevant to patient matching, such as experts in 

21 informatics and data analytics; 

22 (5) stakeholders affected by record-matching (in23 cluding patients, hospitals, health systems, payers, 

24 health information exchanges, and prescription drug 

25 monitoring programs); and 


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1 (6) other representatives, as the Secretary deter2 mines appropriate. 

3 (c) TOPICS.—Such public meeting shall include a dis4 cussion of— 

5 (1) standards and processes for assessing the ac6 curacy of patient-matching algorithms; 

7 (2) performance metrics for health care providers 

8 purchasing patient-matching technology and algo9 rithm developers; 

10 (3) the development of benchmarks for the accu11 racy of patient-matching algorithms; 

12 (4) considerations for State, local, Tribal, and 

13 territorial capabilities and infrastructure related to 

14 data exchange, interoperability, and matching patient 

15 records; 

16 (5) opportunities for the incorporation of inno17 vative technologies to improve patient matching; and 

18 (6) privacy and security protections. 


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Calendar No. 133 

116TH CONGRESS 

1ST SESSION S. 1895 

A BILL 

To lower health care costs. 

JULY 8, 2019 

Reported with an amendment 


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