[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9184 Introduced in House (IH)]

<DOC>






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. Barragan) 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Access Act of 2024''.

SEC. 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.
                                 <all>