I 

118TH CONGRESS 

2D SESSION H. R. 9184 

To amend title XI of the Social Security Act to exclude from antikickback 

and other sanctions certain travel and lodging arrangements between 

manufacturers of drugs and individuals being administered such drugs, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 30, 2024 

Mr. GUTHRIE (for himself and Ms. BARRAGA ́N) 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 XI of the Social Security Act to exclude 

from antikickback and other sanctions certain travel and 

lodging arrangements between manufacturers of drugs 

and individuals being administered such drugs, 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 ‘‘Patient Access Act 

5 of 2024’’. 


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1 SEC. 2. EXCLUDING FROM ANTIKICKBACK AND OTHER 

2 SANCTIONS CERTAIN TRAVEL AND LODGING 

3 ARRANGEMENTS BETWEEN MANUFACTUR4 ERS OF DRUGS AND INDIVIDUALS BEING AD5 MINISTERED SUCH DRUGS. 

6 (a) IN GENERAL.—Section 1128B of the Social Secu7 rity Act (42 U.S.C. 1320a–7b) is amended— 

8 (1) in subsection (b)(3)— 

9 (A) in subparagraph (K), by striking at 

10 the end ‘‘and’’; 

11 (B) in subparagraph (L)(iii), by striking at 

12 the end the period and inserting ‘‘; and’’; and 

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

14 subparagraph: 

15 ‘‘(M) an arrangement described in subsection 

16 (i) between a manufacturer of a drug and an indi17 vidual who is prescribed such drug.’’; and 

18 (2) by adding at the end the following new sub19 section: 

20 ‘‘(i) For purposes of subsection (b)(3)(M), an ar21 rangement described in this subsection between a manu22 facturer of a drug and an individual who is prescribed 

23 such drug is an arrangement entered into on or after Jan24 uary 1, 2025, that satisfies each of the following: 

25 ‘‘(1) The arrangement provides for payment or 

26 reimbursement by the manufacturer for transporVerDate Sep 11 2014 01:31 Aug 27, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H9184.IH H9184

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1 tation, lodging, meals, or other incidental expenses 

2 specified by the Secretary connected with the admin3 istration of such drug and relating to travel to and 

4 from the facility at which such drug is to be admin5 istered, for the individual and up to two caregivers 

6 of the individual (as determined appropriate by the 

7 manufacturer, taking into account the individual’s 

8 age and medical needs) during any portion of the pe9 riod during which such individual is being adminis10 tered such drug (including initial visits to such facil11 ity before such administration, and followup visits to 

12 such facility after such administration, relating to 

13 the administration of such drug). 

14 ‘‘(2) The arrangement does not provide for pay15 ment or reimbursement by the manufacturer for 

16 transportation, lodging, meals, or other incidental 

17 expenses described in paragraph (1) if the manufac18 turer knows that the individual is eligible to receive 

19 at no cost, such transportation, lodging, meals, or 

20 other out-of-pocket expenses, as applicable, from the 

21 facility at which the drug is administered to the in22 dividual. 

23 ‘‘(3) The manufacturer does not advertise the 

24 arrangement and makes good-faith efforts to ensure 

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1 closed to such individual until after such drug is pre2 scribed to such individual, provided that such manu3 facturer does not interfere with a health care pro4 vider’s ability to furnish such individual with any in5 formation determined appropriate by the provider. 

6 ‘‘(4) If the arrangement provides for payment 

7 or reimbursement by the manufacturer for transpor8 tation described in paragraph (1), such payment or 

9 reimbursement is only for— 

10 ‘‘(A) travel that is practical and conven11 ient, taking into account the individual’s mobil12 ity or medical needs, which may include ground 

13 transportation, air transportation, or transpor14 tation by train; 

15 ‘‘(B) the costs directly associated with the 

16 travel for the individual and caregivers as de17 scribed in paragraph (1), such as airfare, taxes, 

18 tolls, gas, or other fees; and 

19 ‘‘(C) travel between the individual’s resi20 dence and the closest facility that is available to 

21 administer such drug in a manner that is medi22 cally appropriate (as determined by the individ23 ual’s health care provider) for the individual (or 

24 between any lodging where such individual is 


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1 staying in relation to such administration and 

2 such facility). 

3 ‘‘(5) If the arrangement provides for payment 

4 or reimbursement by the manufacturer for lodging 

5 described in paragraph (1), such lodging is— 

6 ‘‘(A) reasonable based on the individual’s 

7 age and medical needs; 

8 ‘‘(B) near the facility at which such indi9 vidual is to be administered such drug; and 

10 ‘‘(C) only provided during the period de11 scribed in paragraph (1). 

12 ‘‘(6) If the arrangement provides for payment 

13 or reimbursement by the manufacturer for meals or 

14 other incidental expenses described in paragraph (1), 

15 the amount of such payment or reimbursement does 

16 not exceed the per diem rate in effect for meals and 

17 incidental expenses in the geographic area in which 

18 such facility is located (as established by the General 

19 Services Administration) for the individual and for 

20 each caregiver allowed under the arrangement pur21 suant to paragraph (1). 

22 ‘‘(7) The individual— 

23 ‘‘(A) is determined to have income that 

24 does not exceed the median income applicable to 

25 a family of the size involved in the geographic 


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1 region (as specified by the Secretary) in which 

2 such individual resides; and 

3 ‘‘(B) lives more than 1 hour of driving dis4 tance (or 50 miles) from the nearest facility 

5 that administers such drug and is accepting pa6 tients. 

7 ‘‘(8) Such an arrangement is offered by the 

8 manufacturer to individuals regardless of the facility 

9 involved in the administration of the drug and re10 gardless of the insurance status of the individual. 

11 ‘‘(9) The arrangement requires the individual to 

12 agree to not request reimbursement from any Fed13 eral health care program for any costs for which 

14 payment or reimbursement is made by the manufac15 turer under the arrangement. 

16 ‘‘(10) The manufacturer certifies that the man17 ufacturer does not bill or shift the costs of the ar18 rangement to any of the Federal health care pro19 grams.’’. 

20 (b) GAO STUDY AND REPORT.—Not later than 3 

21 years after the date of the enactment of this section, the 

22 Comptroller General of the United States shall submit to 

23 Congress a report on arrangements between a manufac24 turer of a drug and an individual who is prescribed such 

25 drug described in subsection (i) of section 1128B of the 


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1 Social Security Act (42 U.S.C. 1320a–7b), as added by 

2 subsection (a). Such report shall include— 

3 (1) an analysis of the impact of such arrange4 ments on— 

5 (A) access to transformative therapies, in6 cluding rare disease gene therapies; 

7 (B) access to drugs that are the subject of 

8 such arrangements, including socioeconomic dis9 parities with respect to such access; and 

10 (C) the utilization by such individuals of— 

11 (i) biosimilar biological products that 

12 are the subject to such arrangements, as 

13 compared to the utilization of the biological 

14 products that are the reference products 

15 for such biosimilar biological products; and 

16 (ii) generic drugs that are the subject 

17 to such arrangements, as compared to the 

18 utilization of the drugs that are the ref19 erence drugs for such generic drugs; 

20 (2) a description of any tax benefits obtained in 

21 connection with such arrangements by manufactur22 ers offering such arrangements; 

23 (3) a list of the drugs for which a manufacturer 

24 of such drug offers such an arrangement; 


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1 (4) with respect to each drug that is the subject 

2 of such an agreement— 

3 (A) the average cost directly associated 

4 with the travel to and from the facility at which 

5 such drug is to be administered, for the indi6 vidual administered such drug under such an 

7 arrangement and caregivers of the individual, 

8 as described in subsection (i)(1) of section 

9 1128B of the Social Security Act (42 U.S.C. 

10 1320a–7b), as added by subsection (a); 

11 (B) the average distance so traveled by 

12 such individuals and caregivers; 

13 (C) the average family annual income of 

14 such individuals; 

15 (D) the average length of stay at the facil16 ity at which the drug is administered for such 

17 individuals; 

18 (E) the total number of such individuals 

19 with whom such an arrangement has been 

20 made; and 

21 (F) the percentage of prescriptions for 

22 such drug that are filled when such an arrange23 ment is available to the individual being admin24 istered such drug compared to the percentage 

25 of prescriptions for such drug that are filled 


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1 when such an arrangement is not so available; 

2 and 

3 (5) an analysis of the efficacy of any oversight 

4 conducted to ensure that such arrangements adhere 

5 to any applicable guidance from the Office of the In6 spector General of the Department of Health and 

7 Human Services on avoiding waste, fraud, and 

8 abuse. 

Æ 


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