Federal

Facilitating Innovative Nuclear Diagnostics Act of 2023

Source: Congress.gov · 923 words in original text

What This Bill Does

This bill changes how Medicare pays for diagnostic radiopharmaceuticals (radioactive drugs used to find diseases) that hospitals give to patients. Instead of bundling the cost of expensive diagnostic radiopharmaceuticals into a hospital's overall payment, Medicare will make a separate payment for these drugs when they cost a certain amount or more.

Who It Affects

Medicare beneficiaries (people enrolled in Medicare), hospitals providing outpatient services, and the Centers for Medicare and Medicaid Services.

Key Provisions

- Starting January 1, 2024, Medicare stops combining the cost of expensive diagnostic radiopharmaceuticals with other hospital outpatient costs and instead pays for them separately (Sec. 2(a)). - The separate payment equals the average sales price of the drug, or if that is not available, the wholesale acquisition cost (the price a distributor pays), or if that is not available, cost data from hospital claims (Sec. 2(a)). - A diagnostic radiopharmaceutical qualifies for separate payment only if its estimated daily product cost equals or exceeds a threshold amount, which is $500 in 2024 and increases each year after that (Sec. 2(a)). - The Secretary of Health and Human Services must adjust other payments to ensure Medicare's total spending stays the same with this change (Sec. 2(a)). - Patient copayment responsibility remains unchanged by this separate payment method (Sec. 2(b)).

What Changes

Medicare's payment method changes for high-cost diagnostic radiopharmaceuticals used in hospital outpatient settings. These drugs will receive separate payment instead of being bundled into the hospital's prospective payment system (a method that pays hospitals a set amount based on diagnosis rather than services provided).

Important Definitions

Diagnostic radiopharmaceutical: A drug or biological substance used to diagnose disease that is approved by the Food and Drug Administration on or after January 1, 2008, and meets federal regulations about radioactive diagnostic drugs (Sec. 2(a)).

Effective Date

January 1, 2024 (Sec. 2(a)).

I 118TH CONGRESS 1ST SESSION H. R. 1199 To amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharma- ceuticals under the Medicare hospital outpatient prospective payment system. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 27, 2023 Mr. DUNN of Florida (for himself, Mr. MURPHY, Mr. PETERS, Ms. SEWELL, Mrs. TRAHAN, Ms. BLUNT ROCHESTER, Mrs. MILLER-MEEKS, Mr. AUCHINCLOSS, Mr. TONKO, Mr. JOYCE of Pennsylvania, Mrs. WATSON COLEMAN, Ms. KUSTER, Mr. PAPPAS, Mr. RESCHENTHALER, Mr. MCGOVERN, and Mr. BUCSHON) 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 de- termined 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 ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1199.IH H1199 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 1199 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Facilitating Innovative 2 Nuclear Diagnostics Act of 2023’’. 3 SEC. 2. SEPARATE PAYMENT FOR CERTAIN DIAGNOSTIC 4 RADIOPHARMACEUTICALS. 5 (a) IN GENERAL.—Section 1833(t)(16) of the Social 6 Security Act (42 U.S.C. 1395(t)(16)) is amended by add- 7 ing at the end the following new subparagraph: 8 ‘‘(H) SEPARATE PAYMENT FOR CERTAIN 9 DIAGNOSTIC RADIOPHARMACEUTICALS.— 10 ‘‘(i) IN GENERAL.—Notwithstanding 11 any other provision of this subsection, with 12 respect to services furnished on or after 13 January 1, 2024, the Secretary shall not 14 package, and shall make a separate pay- 15 ment as specified in clause (ii) for a diag- 16 nostic radiopharmaceutical (as defined in 17 clause (v)) with an estimated mean per day 18 product cost equal to or exceeding the 19 threshold specified in clause (iii). 20 ‘‘(ii) SEPARATE PAYMENT.—For pur- 21 poses of clause (i), the separate payment 22 specified in this subclause for a diagnostic 23 radiopharmaceutical described in clause (i) 24 shall be equal to— 25 VerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1199.IH H1199 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 1199 IH ‘‘(I) the average sales price for 1 the drug established under section 2 1847A, to the extent the average sales 3 price is available, as calculated and 4 adjusted by the Secretary to the ex- 5 tent such adjustment is adopted for 6 other specified covered outpatient 7 drugs under paragraph (14)(A); or 8 ‘‘(II) if the data necessary to cal- 9 culate the average sales price for the 10 drug in the year under the section 11 and paragraph specified in subclause 12 (I) is not available, the wholesale ac- 13 quisition cost (as defined in subsection 14 1847A(c)(6)(B)), as calculated and 15 adjusted by the Secretary to the ex- 16 tent such adjustment is adopted for 17 other specified covered outpatient 18 drugs under paragraph (14)(A), or, if 19 the wholesale acquisition cost is not 20 available, the mean unit cost data de- 21 rived from hospital claims data. 22 Nothing in this subparagraph shall be con- 23 strued as affecting eligibility of diagnostic 24 VerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1199.IH H1199 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 1199 IH radiopharmaceuticals for pass-through pay- 1 ments under paragraph (6). 2 ‘‘(iii) THRESHOLD.—For purposes of 3 this subparagraph, the threshold specified 4 in this clause— 5 ‘‘(I) for 2024, is $500; and 6 ‘‘(II) for a subsequent year, is 7 the amount specified in this clause for 8 the preceding year increased by the 9 OPD fee schedule increase factor 10 under paragraph (3)(C)(iv) for the 11 year. 12 ‘‘(iv) BUDGET NEUTRALITY.—The 13 Secretary shall make such adjustments as 14 are necessary under paragraph (9)(B) to 15 ensure that the amount of expenditures 16 under this subsection for a year with appli- 17 cation of this subparagraph is equal to the 18 amount of expenditures that would be 19 made under this subsection for such year 20 without application of this subparagraph. 21 ‘‘(v) DEFINITION OF DIAGNOSTIC 22 RADIOPHARMACEUTICAL.—For purposes of 23 this subparagraph, the term ‘diagnostic 24 radiopharmaceutical’ means a drug or bio- 25 VerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1199.IH H1199 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 1199 IH logical that is described in section 315.2(a) 1 of title 21, Code of Federal Regulations, or 2 any successor regulation, and is approved 3 by the Food and Drug Administration on 4 or after January 1, 2008.’’. 5 (b) NO IMPACT ON COPAYMENT.—Section 6 1833(t)(8)(E) of the Social Security Act (42 U.S.C. 7 1395l(t)(8)(E)) is amended— 8 (1) in the heading, by inserting ‘‘AND SEPA- 9 RATE PAYMENTS FOR CERTAIN DIAGNOSTIC RADIO- 10 PHARMACEUTICALS’’ after ‘‘PASS-THROUGH ADJUST- 11 MENTS’’; and 12 (2) by inserting ‘‘and paragraph (16)(H)’’ after 13 ‘‘such adjustments)’’. 14 Æ VerDate Sep 11 2014 07:12 Mar 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H1199.IH H1199 kjohnson on DSK79L0C42PROD with BILLS

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