I 118th CONGRESS 2d Session H. R. 9184 IN THE HOUSE OF REPRESENTATIVES July 30, 2024 Mr. Guthrie (for himself and Ms. Barragán ) 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. Short title This Act may be cited as the Patient Access Act of 2024 . 2. Excluding from antikickback and other sanctions certain travel and lodging arrangements between manufacturers of drugs and individuals being administered such drugs (a) In general Section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ) is amended— (1) in subsection (b)(3)— (A) in subparagraph (K), by striking at the end and ; (B) in subparagraph (L)(iii), by striking at the end the period and inserting ; and ; and (C) by adding at the end the following new subparagraph: (M) an arrangement described in subsection (i) between a manufacturer of a drug and an individual who is prescribed such drug. ; and (2) by adding at the end the following new subsection: (i) For purposes of subsection (b)(3)(M), an arrangement described in this subsection between a manufacturer of a drug and an individual who is prescribed such drug is an arrangement entered into on or after January 1, 2025, that satisfies each of the following: (1) The arrangement provides for payment or reimbursement by the manufacturer for transportation, lodging, meals, or other incidental expenses specified by the Secretary connected with the administration of such drug and relating to travel to and from the facility at which such drug is to be administered, for the individual and up to two caregivers of the individual (as determined appropriate by the manufacturer, taking into account the individual’s age and medical needs) during any portion of the period during which such individual is being administered such drug (including initial visits to such facility before such administration, and followup visits to such facility after such administration, relating to the administration of such drug). (2) The arrangement does not provide for payment or reimbursement by the manufacturer for transportation, lodging, meals, or other incidental expenses described in paragraph (1) if the manufacturer knows that the individual is eligible to receive at no cost, such transportation, lodging, meals, or other out-of-pocket expenses, as applicable, from the facility at which the drug is administered to the individual. (3) The manufacturer does not advertise the arrangement and makes good-faith efforts to ensure that the availability of such arrangement is not disclosed to such individual until after such drug is prescribed to such individual, provided that such manufacturer does not interfere with a health care provider’s ability to furnish such individual with any information determined appropriate by the provider. (4) If the arrangement provides for payment or reimbursement by the manufacturer for transportation described in paragraph (1), such payment or reimbursement is only for— (A) travel that is practical and convenient, taking into account the individual’s mobility or medical needs, which may include ground transportation, air transportation, or transportation by train; (B) the costs directly associated with the travel for the individual and caregivers as described in paragraph (1), such as airfare, taxes, tolls, gas, or other fees; and (C) travel between the individual’s residence and the closest facility that is available to administer such drug in a manner that is medically appropriate (as determined by the individual’s health care provider) for the individual (or between any lodging where such individual is staying in relation to such administration and such facility). (5) If the arrangement provides for payment or reimbursement by the manufacturer for lodging described in paragraph (1), such lodging is— (A) reasonable based on the individual’s age and medical needs; (B) near the facility at which such individual is to be administered such drug; and (C) only provided during the period described in paragraph (1). (6) If the arrangement provides for payment or reimbursement by the manufacturer for meals or other incidental expenses described in paragraph (1), the amount of such payment or reimbursement does not exceed the per diem rate in effect for meals and incidental expenses in the geographic area in which such facility is located (as established by the General Services Administration) for the individual and for each caregiver allowed under the arrangement pursuant to paragraph (1). (7) The individual— (A) is determined to have income that does not exceed the median income applicable to a family of the size involved in the geographic region (as specified by the Secretary) in which such individual resides; and (B) lives more than 1 hour of driving distance (or 50 miles) from the nearest facility that administers such drug and is accepting patients. (8) Such an arrangement is offered by the manufacturer to individuals regardless of the facility involved in the administration of the drug and regardless of the insurance status of the individual. (9) The arrangement requires the individual to agree to not request reimbursement from any Federal health care program for any costs for which payment or reimbursement is made by the manufacturer under the arrangement. (10) The manufacturer certifies that the manufacturer does not bill or shift the costs of the arrangement to any of the Federal health care programs. . (b) GAO study and report Not later than 3 years after the date of the enactment of this section, the Comptroller General of the United States shall submit to Congress a report on arrangements between a manufacturer of a drug and an individual who is prescribed such drug described in subsection (i) of section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ), as added by subsection (a) . Such report shall include— (1) an analysis of the impact of such arrangements on— (A) access to transformative therapies, including rare disease gene therapies; (B) access to drugs that are the subject of such arrangements, including socioeconomic disparities with respect to such access; and (C) the utilization by such individuals of— (i) biosimilar biological products that are the subject to such arrangements, as compared to the utilization of the biological products that are the reference products for such biosimilar biological products; and (ii) generic drugs that are the subject to such arrangements, as compared to the utilization of the drugs that are the reference drugs for such generic drugs; (2) a description of any tax benefits obtained in connection with such arrangements by manufacturers offering such arrangements; (3) a list of the drugs for which a manufacturer of such drug offers such an arrangement; (4) with respect to each drug that is the subject of such an agreement— (A) the average cost directly associated with the travel to and from the facility at which such drug is to be administered, for the individual administered such drug under such an arrangement and caregivers of the individual, as described in subsection (i)(1) of section 1128B of the Social Security Act ( 42 U.S.C. 1320a–7b ), as added by subsection (a) ; (B) the average distance so traveled by such individuals and caregivers; (C) the average family annual income of such individuals; (D) the average length of stay at the facility at which the drug is administered for such individuals; (E) the total number of such individuals with whom such an arrangement has been made; and (F) the percentage of prescriptions for such drug that are filled when such an arrangement is available to the individual being administered such drug compared to the percentage of prescriptions for such drug that are filled when such an arrangement is not so available; and (5) an analysis of the efficacy of any oversight conducted to ensure that such arrangements adhere to any applicable guidance from the Office of the Inspector General of the Department of Health and Human Services on avoiding waste, fraud, and abuse.