I 

118TH CONGRESS 

1ST SESSION H. R. 5647 

To amend title XXVII of the Public Health Service Act to require outof-network coverage for qualified individuals diagnosed with a rare pediatric disease participating in approved clinical trials, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 21, 2023 

Mr. MCCAUL (for himself, Mr. BERA, and Mr. KELLY of Pennsylvania) introduced the following bill; which was referred to the Committee on Energy 

and Commerce, and in addition to the Committee on Ways and Means, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

A BILL 

To amend title XXVII of the Public Health Service Act 

to require out-of-network coverage for qualified individuals diagnosed with a rare pediatric disease participating 

in approved clinical trials, and for other purposes. 

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. 

4 This Act may be cited as the ‘‘Childhood Cancer Clin5 ical Trials Act’’. 


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1 SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDI2 VIDUAL AND GROUP MARKET AND UNDER 

3 MEDICARE PROGRAM FOR QUALIFIED INDI4 VIDUALS DIAGNOSED WITH A RARE PEDI5 ATRIC DISEASE PARTICIPATING IN AP6 PROVED CLINICAL TRIALS. 

7 (a) INDIVIDUAL AND GROUP MARKET.— 

8 (1) REQUIRING OUT-OF-NETWORK COVERAGE

9 OF ROUTINE PATIENT COSTS.—Section 2709 of the 

10 Public Health Service Act (42 U.S.C. 300gg–8) is 

11 amended— 

12 (A) in subsection (a)(2)— 

13 (i) in subparagraph (A), by inserting 

14 ‘‘and subsection (c)(2)’’ after ‘‘(1)(B)’’; 

15 and 

16 (ii) in subparagraph (B), by inserting 

17 ‘‘and subsection (c)(2)’’ after ‘‘(1)(B)’’; 

18 (B) by amending subsection (c) to read as 

19 follows: 

20 ‘‘(c) TREATMENT OF NON-PARTICIPATING PRO21 VIDERS.— 

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

23 this section shall not be construed to require a group 

24 health plan, or a health insurance issuer offering 

25 group or individual health insurance coverage, to 

26 provide benefits for routine patient care services proVerDate Sep 11 2014 03:27 Sep 26, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5647.IH H5647

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1 vided outside of the plan’s (or coverage’s) health 

2 care provider network unless out-of-network benefits 

3 are otherwise provided under the plan (or coverage). 

4 ‘‘(2) QUALIFIED INDIVIDUALS DIAGNOSED

5 WITH A RARE PEDIATRIC DISEASE.—In the case of 

6 a qualified individual diagnosed with a rare pediatric 

7 disease, with respect to routine patient costs for 

8 items and services furnished to such individual in 

9 connection with participation in an approved clinical 

10 trial by a nonparticipating provider, a group health 

11 plan or health insurance issuer offering group or in12 dividual health insurance coverage that provides cov13 erage to such individual— 

14 ‘‘(A) shall impose the same cost-sharing 

15 requirement (expressed as a copayment amount 

16 or coinsurance rate) that would apply if such 

17 item or service was furnished by a participating 

18 provider; and 

19 ‘‘(B) shall pay to such nonparticipating 

20 provider the amount by which the recognized 

21 amount for such item or service exceeds the 

22 cost-sharing amount for such item or service 

23 (as determined in accordance with subpara24 graph (A)).’’; and 


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1 (C) by adding at the end the following new 

2 subsection: 

3 ‘‘(i) OTHER DEFINITIONS.— 

4 ‘‘(1) NONPARTICIPATING PROVIDER; PARTICI5 PATING PROVIDER; RECOGNIZED AMOUNT.—For 

6 purposes of this section, the terms ‘nonparticipating 

7 provider’, ‘participating provider’, and ‘recognized 

8 amount’ have the meaning given such terms in sec9 tion 2799A–1(a)(3). 

10 ‘‘(2) RARE PEDIATRIC DISEASE.—The term 

11 ‘rare pediatric disease’ has the meaning given such 

12 term in section 529(a)(3) of the Federal Food, 

13 Drug, and Cosmetic Act.’’. 

14 (2) AMENDMENT RELATING TO DEFINITION OF

15 ROUTINE PATIENT COSTS.—Section 2709(a)(2)(A) 

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

17 8(a)(2)(A)) is amended— 

18 (A) by striking ‘‘include all items and serv19 ices’’ and inserting ‘‘include— 

20 ‘‘(i) all items and services’’; and 

21 (B) by striking the period at the end and 

22 inserting ‘‘; and 

23 ‘‘(ii) consultation and referral services 

24 relating to approved clinical trials fur25 nished to qualified individuals.’’. 


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1 (3) AMENDMENT RELATING TO DEFINITION OF

2 APPROVED CLINICAL TRIAL.—Section 2709(d)(1)(A) 

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

4 8(d)(1)(A)) is amended by adding at the end the fol5 lowing new clause: 

6 ‘‘(viii) The Patient-Centered Out7 comes Research Institute.’’. 

8 (4) TECHNICAL AND CONFORMING AMEND9 MENTS.—Section 2709 of the Public Health Service 

10 Act (42 U.S.C. 300gg–8), as amended by the pre11 ceding paragraphs, is further amended— 

12 (A) in subsection (a)— 

13 (i) in paragraph (1)(A), by inserting 

14 before ‘‘clinical trial referred to in sub15 section (b)(2)’’ the following: ‘‘approved’’; 

16 (ii) in paragraph (2)(A), by striking 

17 ‘‘a clinical trial’’ and inserting ‘‘an ap18 proved clinical trial’’; 

19 (iii) in paragraph (3)— 

20 (I) by striking ‘‘IN-NETWORK

21 PROVIDERS’’ and inserting ‘‘PARTICI22 PATING PROVIDERS’’; and 

23 (II) by striking ‘‘a clinical trial’’ 

24 and inserting ‘‘an approved clinical 

25 trial’’; and 


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1 (iv) in paragraph (4), by striking 

2 ‘‘OUT-OF-NETWORK’’ and inserting ‘‘NON3 PARTICIPATING PROVIDERS’’; 

4 (B) in subsection (b)(2)(A), by striking 

5 ‘‘participating health care provider’’ and insert6 ing ‘‘participating provider’’; and 

7 (C) in subsection (d)(1)(A)(v), by striking 

8 ‘‘cooperative group’’ and inserting ‘‘A coopera9 tive group’’. 

10 (5) EFFECTIVE DATE.—The amendments made 

11 by this subsection shall apply with respect to plan 

12 years beginning on or after January 1, 2024. 

13 (b) MEDICARE.— 

14 (1) AMENDMENT RELATING TO DEFINITION OF

15 ROUTINE COSTS OF CARE.—Section 1862(m) of the 

16 Social Security Act (42 U.S.C. 1395y(m)) is amend17 ed— 

18 (A) in paragraph (1), by inserting before 

19 ‘‘as defined by the Secretary’’ the following: 

20 ‘‘subject to paragraph (3),’’; and 

21 (B) by adding at the end the following new 

22 paragraph: 

23 ‘‘(3) ROUTINE COSTS OF CARE.—In defining 

24 ‘routine costs of care’ for purposes of paragraph (1), 

25 the Secretary shall define such term in a manner 


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1 that provides for coverage of consultation and refer2 ral services furnished to an individual in the course 

3 of participation in a category A clinical trial.’’. 

4 (2) AMENDMENT RELATING TO DEFINITION OF

5 CATEGORY A CLINICAL TRIAL.—Section 1862(m)(2) 

6 of the Social Security Act (42 U.S.C. 1395y(m)(2)) 

7 is amended by inserting after ‘‘means a trial’’ the 

8 following: ‘‘(including a trial funded by the Patient9 Centered Outcomes Research Institute)’’. 

10 (3) EFFECTIVE DATE.—The amendments made 

11 by this subsection shall apply with respect to items 

12 and services furnished on or after January 1, 2024. 

13 SEC. 3. VOLUNTARY NETWORK OF PARTICIPATING PRO14 VIDERS. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services may issue a request for information from 

17 group health plans, and health insurance issuers offering 

18 group or individual health coverage to identify an interest 

19 in establishing a voluntary network of participating pro20 viders administered by a third-party administrator (as 

21 designated by the Secretary) for purposes of complying 

22 with coverage requirements for clinical trials under section 

23 2709 of the Public Health Service Act (42 U.S.C. 300gg– 

24 8). 

25 (b) DEFINITIONS.—In this section: 


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1 (1) GROUP HEALTH PLAN.—The term ‘‘group 

2 health plan’’ has the meaning given such term in 

3 section 607(1) of the Employee Retirement Income 

4 Security Act of 1974 (29 U.S.C. 1167(1)). 

5 (2) HEALTH INSURANCE ISSUER.—The term 

6 ‘‘health insurance issuer’’ has the meaning given 

7 such term in section 2791(b)(1) of the Public Health 

8 Service Act (42 U.S.C. 300gg–91(b)(1)). 

9 (3) PARTICIPATING PROVIDER.—The term 

10 ‘‘participating provider’’ has the meaning given such 

11 term in section 2799A–1(a)(3)(G)(ii) of the Public 

12 Health Service Act (42 U.S.C. 300gg– 

13 111(a)(3)(G)(ii)). 

Æ 


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