Seniors’ Access to Critical Medications Act of 2024

Bill: 118-hr-5526
Sponsor: full_name: Rep. Harshbarger, Diana [R-TN-1]
Introduced: 2023-09-18
Policy area: Health
Subjects: Government information and archives

Internet, web applications, social media

Medicare

Prescription drugs
Latest action: action_date: 2024-09-24
text: Received in the Senate and Read twice and referred to the Committee on Finance.

Summaries:
action_date: 2023-09-18
action_desc: Introduced in House
text: <p><strong>Seniors’ Access to Critical Medications Act of 2023</strong></p><p>This bill allows physicians to dispense outpatient prescription drugs and related supplies to patients outside of their office buildings without violating certain prohibitions under the Stark law (i.e., the Physician Self-Referral Law) for Medicare and Medicaid.</p><p>Current law requires physicians to dispense outpatient prescription drugs and related supplies to patients in their office buildings in order to qualify for an exception (the in-office ancillary services exception) under the Stark law. The bill specifies that, beginning on May 11, 2023, physicians may dispense outpatient prescription drugs and related supplies in locations other than their office buildings.</p><p>The bill also requires the Centers for Medicare &amp; Medicaid Services to withdraw specified guidance that contradicts the bill’s changes.</p>

action_date: 2024-09-23
action_desc: Passed House
text: <p><strong>Seniors’ Access to Critical Medications Act of 2024</strong></p><p>This bill temporarily allows physicians to dispense outpatient prescription drugs and related supplies under the Medicare prescription drug benefit to patients via mail or to their caregivers without violating certain prohibitions under the Stark law (i.e., the Physician Self-Referral Law), if certain conditions are met. It also allows for coverage of certain external infusion pumps and associated home infusion drugs under Medicare.</p><p>Current law requires physicians to dispense outpatient prescription drugs and related supplies to patients in their office buildings in order to qualify for an exception (the in-office ancillary services exception) under the Stark law. The bill specifies that, from January 1, 2025 to December 31, 2029, physicians may dispense outpatient prescription drugs and related supplies to their patients via mail, and individuals or their family members or caregivers may pick up such items at the physician's office building, if the individual (1) had a face-to-face visit with the prescriber in the prior year, not including telehealth visits; (2) the prescriber furnished other items or services to the individual in the prior year; and (3) the prescriber has an ongoing professional relationship with the individual.&nbsp;</p><p>In addition, the bill specifies that external infusion pumps and associated home infusion drugs may be covered under Medicare even if they don't meet certain regulatory requirements, if these items are provided in accordance with the bill's specified criteria, including that the drug is administered under the supervision of a qualified home infusion therapy supplier.</p>

tv_txt: IIB 118th CONGRESS 2d Session H. R. 5526 IN THE SENATE OF THE UNITED STATES September 24, 2024 Received; read twice and referred to the Committee on Finance AN ACT To amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program, and to provide coverage of external infusion pumps and non-self-administrable home infusion drugs under such program.

1. Short title This Act may be cited as the Seniors’ Access to Critical Medications Act of 2024 . 2. Clarifying the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program (a) In general Section 1877(b)(2) of the Social Security Act ( 42 U.S.C. 1395nn(b)(2) ) is amended by adding at the end the following new sentence: With respect to services described in subsection (h)(6)(J) consisting of covered part D drugs (as defined in section 1860D–2(e)) furnished to an individual during the period beginning on January 1, 2025, and ending on December 31, 2029, such drugs shall be treated as having been furnished in accordance with subparagraph (A)(ii) if such drugs are picked up in a building described in subclause (I) or (II) of such subparagraph by such individual, or a family member or caregiver on behalf of such individual, or delivered to such individual by a mail, delivery, or courier service, but only if, during the 1-year period ending on the date such drugs were so furnished, such individual had a face-to-face encounter with the prescriber of such drugs (not including any such encounter conducted via telehealth), and only if such prescriber (or another physician or practitioner (as described in section 1842(b)(18)(C)) in the same practice as such prescriber (as determined by tax identification number)) furnished to such individual, during such 1-year period, another item or service for which payment was made under this title, and only if such individual has an ongoing relationship with such prescriber. . (b) Report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains— (1) the number of individuals who were furnished drugs in a manner that would constitute a violation of section 1877 of the Social Security Act ( 42 U.S.C. 1395nn ) but for the amendment made by subsection (a); (2) an analysis of the change in expenditures under title XVIII of such Act ( 42 U.S.C. 1395 et seq. ) attributable to such amendment; (3) a description of which drugs were furnished in a manner described in paragraph (1); and (4) such amendment’s impact on prices for such drugs. 3. Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs Section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) ) is amended by adding at the end the following new sentence: Beginning with the first calendar quarter beginning on or after the date that is one year after the date of the enactment of the Seniors’ Access to Critical Medications Act of 2024 , an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied: (1) The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional. (2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)). (3) The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year— (A) intravenously or subcutaneously; or (B) at infusion rates that the Secretary determines would require the use of an external infusion pump. . 4. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act ( 42 U.S.C. 1395iii(b)(1) ) is amended by striking $0 and inserting $114,000,000 .

Passed the House of Representatives September 23, 2024. Kevin F. McCumber, Clerk.

tv_txt: I 118th CONGRESS 2d Session H. R. 5526 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program, and to provide coverage of external infusion pumps and non-self-administrable home infusion drugs under such program.

1. Short title This Act may be cited as the Seniors’ Access to Critical Medications Act of 2024 . 2. Clarifying the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program (a) In general Section 1877(b)(2) of the Social Security Act ( 42 U.S.C. 1395nn(b)(2) ) is amended by adding at the end the following new sentence: With respect to services described in subsection (h)(6)(J) consisting of covered part D drugs (as defined in section 1860D–2(e)) furnished to an individual during the period beginning on January 1, 2025, and ending on December 31, 2029, such drugs shall be treated as having been furnished in accordance with subparagraph (A)(ii) if such drugs are picked up in a building described in subclause (I) or (II) of such subparagraph by such individual, or a family member or caregiver on behalf of such individual, or delivered to such individual by a mail, delivery, or courier service, but only if, during the 1-year period ending on the date such drugs were so furnished, such individual had a face-to-face encounter with the prescriber of such drugs (not including any such encounter conducted via telehealth), and only if such prescriber (or another physician or practitioner (as described in section 1842(b)(18)(C)) in the same practice as such prescriber (as determined by tax identification number)) furnished to such individual, during such 1-year period, another item or service for which payment was made under this title, and only if such individual has an ongoing relationship with such prescriber. . (b) Report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains— (1) the number of individuals who were furnished drugs in a manner that would constitute a violation of section 1877 of the Social Security Act ( 42 U.S.C. 1395nn ) but for the amendment made by subsection (a); (2) an analysis of the change in expenditures under title XVIII of such Act ( 42 U.S.C. 1395 et seq. ) attributable to such amendment; (3) a description of which drugs were furnished in a manner described in paragraph (1); and (4) such amendment’s impact on prices for such drugs. 3. Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs Section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) ) is amended by adding at the end the following new sentence: Beginning with the first calendar quarter beginning on or after the date that is one year after the date of the enactment of the Seniors’ Access to Critical Medications Act of 2024 , an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied: (1) The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional. (2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)). (3) The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year— (A) intravenously or subcutaneously; or (B) at infusion rates that the Secretary determines would require the use of an external infusion pump. . 4. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act ( 42 U.S.C. 1395iii(b)(1) ) is amended by striking $0 and inserting $114,000,000 .

Passed the House of Representatives September 23, 2024. Kevin F. McCumber, Clerk.

tv_txt: IB Union Calendar No. 585 118th CONGRESS 2d Session H. R. 5526 [Report No. 118–691, Part I] IN THE HOUSE OF REPRESENTATIVES September 18, 2023 Mrs. Harshbarger (for herself, Ms. Wasserman Schultz , Mr. Fleischmann , Mr. Davis of North Carolina , Mrs. Miller-Meeks , and Mr. Balderson ) 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 September 19, 2024 Additional sponsors: Mr. Johnson of Ohio , Mr. Hudson , Ms. Blunt Rochester , Mr. LaLota , Mr. Ruiz , Mr. Carter of Georgia , Mr. Soto , Ms. Sewell , Mr. Cohen , Ms. Tokuda , Mr. Crenshaw , Mr. Bilirakis , Mr. Joyce of Pennsylvania , Ms. Pingree , Ms. Perez , Mr. Van Drew , Mr. Pfluger , Mr. Pappas , Mr. Ferguson , Mr. LaHood , Ms. Kuster , Mr. Dunn of Florida , Mr. Crow , Mr. Bucshon , Mr. Burgess , Mr. Latta , Mr. Golden of Maine , Mrs. Miller of West Virginia , Mr. Krishnamoorthi , Mr. Rutherford , Mr. Obernolte , Mr. Mann , Mr. DesJarlais , Mr. Bacon , Mr. Nehls , Ms. Budzinski , Mr. Kustoff , Ms. Spanberger , Mr. Gottheimer , Ms. Caraveo , Mr. Griffith , Mr. Schneider , Mr. Jackson of North Carolina , Mr. Cartwright , Mr. Langworthy , Mr. Murphy , Mr. Tonko , Mr. Duncan , Mr. D'Esposito , Mr. Williams of New York , Mr. Rouzer , Mr. Green of Tennessee , Ms. Malliotakis , Mr. Weber of Texas , Mr. Tiffany , Ms. Titus , Mrs. Fletcher , Ms. Ross , Mr. Allred , Mr. Carter of Texas , Ms. Strickland , Mr. Moran , Mr. Estes , and Mr. Phillips September 19, 2024 Reported from the Committee on Energy and Commerce with amendments Strike out all after the enacting clause and insert the part printed in italic September 19, 2024 Committee on Ways and Means discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed For text of introduced bill, see copy of bill as introduced on September 18, 2023 A BILL To amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.

1. Short title This Act may be cited as the Seniors’ Access to Critical Medications Act of 2024 . 2. Clarifying the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program (a) In general Section 1877(b)(2) of the Social Security Act ( 42 U.S.C. 1395nn(b)(2) ) is amended by adding at the end the following new sentence: With respect to services described in subsection (h)(6)(J) consisting of covered part D drugs (as defined in section 1860D–2(e)) furnished to an individual during the period beginning on January 1, 2025, and ending on December 31, 2029, such drugs shall be treated as having been furnished in accordance with subparagraph (A)(ii) if such drugs are picked up in a building described in subclause (I) or (II) of such subparagraph by such individual, or a family member or caregiver on behalf of such individual, or delivered to such individual by a mail, delivery, or courier service, but only if, during the 1-year period ending on the date such drugs were so furnished, such individual had a face-to-face encounter with the prescriber of such drugs (not including any such encounter conducted via telehealth), and only if such individual has an ongoing on preexisting relationship with such prescriber. . (b) Report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains— (1) the number of individuals who were furnished drugs in a manner that would constitute a violation of section 1877 of the Social Security Act ( 42 U.S.C. 1395nn ) but for the amendment made by subsection (a); (2) an analysis of the change in expenditures under title XVIII of such Act ( 42 U.S.C. 1395 et seq. ) attributable to such amendment; (3) a description of which drugs were furnished in a manner described in paragraph (1); and (4) such amendment’s impact on prices for such drugs. 3. Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs Section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) ) is amended by adding at the end the following new sentence: Beginning with the first calendar quarter beginning on or after the date that is one year after the date of the enactment of the Seniors’ Access to Critical Medications Act of 2024 , an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied: (1) The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional. (2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)). (3) The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year— (A) intravenously or subcutaneously; or (B) at infusion rates that the Secretary determines would require the use of an external infusion pump. . 4. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act ( 42 U.S.C. 1395iii(b)(1) ) is amended by striking $0 and inserting $114,000,000 .

Amend the title so as to read: A bill to amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program, and to provide coverage of external infusion pumps and non-self-administrable home infusion drugs under such program. .

September 19, 2024 Reported from the Committee on Energy and Commerce with amendments September 19, 2024 Committee on Ways and Means discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: I 118th CONGRESS 1st Session H. R. 5526 IN THE HOUSE OF REPRESENTATIVES September 18, 2023 Mrs. Harshbarger (for herself, Ms. Wasserman Schultz , Mr. Fleischmann , Mr. Davis of North Carolina , Mrs. Miller-Meeks , and Mr. Balderson ) 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 XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.

1. Short title This Act may be cited as the Seniors’ Access to Critical Medications Act of 2023 . 2. Clarifying the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program (a) In general Section 1877(b)(2) of the Social Security Act ( 42 U.S.C. 1395nn(b)(2) ) is amended by adding at the end the following new sentence: With respect to services consisting of drugs, and any supplies necessary to administer such drugs, furnished on or after May 11, 2023, the requirement that such drugs and supplies be furnished in accordance with subparagraph (A)(ii) in order to qualify as a case described in this paragraph shall not apply. . (b) Withdrawal of FAQs The Secretary of Health and Human Services shall remove the frequently asked questions and answers published on the website of the Centers for Medicare & Medicaid Services on September 20, 2021, and May 19, 2023, which prohibit or seek to prohibit the arrangement described in the amendment made by subsection (a) and those frequently asked questions and answers shall be deemed to have never been published.