Global Benchmark for Efficient Drug Pricing (GLOBE) Model

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Part 513</CFR> <DEPDOC>[CMS-5545-P]</DEPDOC> <RIN>RIN 0938-AV66</RIN> <SUBJECT>Global Benchmark for Efficient Drug Pricing (GLOBE) Model</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule proposes to implement the Global Benchmark for Efficient Drug Pricing Model (“GLOBE Model”), a new Medicare payment model under section 1115A of the Social Security Act (the Act). The GLOBE Model would test whether a payment model that uses an alternative method for calculating Part B inflation rebate amounts for certain separately payable Part B drugs and biologicals products reduces costs for Medicare fee-for-service (FFS) beneficiaries and the Medicare program while preserving quality of care. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below, by February 23, 2026. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-5545-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5545-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5545-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Vinod Mitta, (667) 290-8712 or <E T="03">GLOBEmodel@cms.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: <E T="03">http://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. CMS will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. We encourage commenters to include supporting facts, research, and evidence in their comments. When doing so, commenters are encouraged to provide citations to the published materials referenced, including active hyperlinks. Likewise, commenters who reference materials which have not been published are encouraged to upload relevant data collection instruments, data sets, and detailed findings as a part of their comment. Providing such citations and documentation will assist us in analyzing the comments. <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this rule may be found at <E T="03">https://www.regulations.gov/.</E> <HD SOURCE="HD1">I. Executive Summary and Background</HD> <HD SOURCE="HD2">A. Executive Summary</HD> <HD SOURCE="HD3">1. Purpose </HD> The purpose of this proposed rule is to propose the implementation and testing of a new mandatory model under the authority of the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) (Innovation Center). Section 1115A of the Social Security Act (the Act) authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and Children's Health Insurance Program (CHIP) expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of such programs. <HD SOURCE="HD3">2. Summary of Major Provisions</HD> <HD SOURCE="HD3">a. Proposed GLOBE Model Drugs</HD> The proposed Global Benchmark for Efficient Drug Pricing Model (“GLOBE Model”) would focus on a set of Part B rebatable drugs that are single source drugs and sole source biological products that are furnished to a cohort of beneficiaries in the traditional Medicare program. The set of included drugs, as proposed in section II.B. of this proposed rule, would include certain Part B rebatable drugs as identified in 42 CFR 427.101 for the purpose of the Medicare Part B Drug Inflation Rebate Program and that meet the proposed definition of GLOBE Model drugs in proposed 42 CFR 513.130. Drug selection (and removal, if applicable) for the model test would be determined by CMS based on the eligibility criteria and would not be subject to appeal. <HD SOURCE="HD3">b. Proposed Defined Population and Intervention</HD> The proposed cohort of beneficiaries is described in section II.C. of this proposed rule. This cohort would be identified from approximately 25 percent of beneficiaries who are enrolled in traditional Medicare Part B and meet certain criteria (as determined by CMS as set forth in proposed 42 CFR 513.120). These beneficiaries must have traditional Medicare Part B as their primary payer, as defined by a beneficiary being enrolled in Medicare Part B fee-for-service (FFS), and must not be enrolled in a Medicare Advantage plan, section 1876 cost plan, <SU>1</SU> <FTREF/> or section 1833 healthcare prepayment plan. <SU>2</SU> <FTREF/> Beneficiaries must not have other group health coverage that is a primary payer (such as employer-sponsored health insurance). Finally, beneficiaries must be identified by CMS for inclusion in the model (based on the beneficiary's address of record at a certain point in time being within the GLOBE Model geographic areas) and must not be identified by CMS for inclusion in the comparison group or otherwise not eligible for inclusion. Medicare beneficiaries who are in the selected cohort, or “GLOBE Model beneficiaries,” would not be model participants  <SU>3</SU> <FTREF/> but would benefit from reduced coinsurance, as applicable, when they receive a GLOBE Model drug as described in section II.G.7. of this proposed rule. When a GLOBE Model beneficiary receives a GLOBE Model drug on a date of service where they are identified as a GLOBE Model beneficiary, separately payable claim lines for that service would be included in the calculation of GLOBE Model billing units as described in section II.G.4. of this proposed rule. Beneficiary selection for the model cohort and comparison group (and removal, if applicable) would be solely determined by CMS and would not be subject to appeal. Providers and suppliers who furnish GLOBE Model drugs to Medicare FFS beneficiaries who are in the model cohort would not be model participants and would continue to buy and bill for GLOBE Model drugs as usual and receive separate payment under Medicare Part B (if applicable). These providers and suppliers include, but may not be limited to, hospital outpatient departments, physician practices, ambulatory surgical centers, pharmacies enrolled as durable medical equipment (DME) suppliers. When the GLOBE Model reduced beneficiary coinsurance applies to units of GLOBE Model drugs furnished to Medicare Part B FFS beneficiaries who are included in the GLOBE Model beneficiary cohort, the provider or supplier would reduce the amount of coinsurance charged to the beneficiary and the portion of the Medicare Part B allowed amount that would be payable by Medicare Part B would be adjusted upwards. For example, if the Medicare Part B allowed amount under the GLOBE Model is $100 and the GLOBE Model beneficiary coinsurance percentage is reduced to 10 percent (instead of the usual 20 percent), the Medicare Part B program payment to the provider or supplier would be adjusted upward and would be $90 (instead of the usual $80) and the beneficiary coinsurance financial responsibility would be $10. <FTNT> <SU>1</SU>  As established in section 1876 of the Act (42 U.S.C. 1395mm). </FTNT> <FTNT> <SU>2</SU>  As established in section 1833 of the Act (42 U.S.C. 1395l). </FTNT> <FTNT> <SU>3</SU>  As proposed in section II.E. of this proposed rule, manufacturers of GLOBE Model drugs would be model participants. </FTNT> <HD SOURCE="HD3">c. Proposed Manufacturer Participation</HD> The proposed GLOBE Model would require mandatory participation for all manufacturers (as defined in 42 CFR 427.20) of Part B rebatable drugs that are also GLOBE Model drugs <E T="03">(</E> as identified in proposed 42 CFR 513.130 and discussed in section II.B. of this proposed rule). When Part B rebatable drugs subject to the GLOBE Model are furnished to Medicare FFS beneficiaries who are in the model cohort, manufacturers that are GLOBE Model participants would pay GLOBE Model rebates to the Medicare Part B account in the Federal Supplementary Medical Insur ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 617k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━