0938-AT91 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS International Pricing Index Model For Medicare Part B Drugs (CMS-5528-P)

This proposed rule considers testing changes to payment for certain separately payable Part B drugs and biologicals.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Regulatory 42 CFR 513 Social Security Act, sec. 1115A Yes

The underlying issue addressed by the proposed rule is that the current Medicare Part B payment system has several features that may be incentivizing avoidable costs, causing greater utilization of higher priced drugs, encouraging prescription drug manufacturers to set higher list prices, and creating inequities between U.S. payment and payment in other countries.  By testing ways to address these payment issues, the model seeks to improve quality of care, address features of the current payment system that may be incentivizing unnecessary Medicare Part B drug spending and utilization of high cost drugs, and ensure that the Medicare program and its beneficiaries pay generally comparable prices for Part B drugs relative to certain other countries.

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This rule is necessary to test a new payment and service delivery model under the authority of section 1115A of the Act, which allows the Innovation Center to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and CHIP beneficiaries.

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This proposed rule contains a range of policies. Alternatives that we considered and rationales for our proposals are included in the rule.

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We believe the rule would substantially lower Medicare spending and beneficiary cost sharing for the Medicare Part B drugs with the highest annual spending over the course of the model.  As we move toward publication, estimates of costs and benefits will be included in the proposed rule.

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Risks of the proposals in this rule are still under development and will be included in the published rule for comment.

]]> ANPRM 10/30/2018 83 FR 54546 ANPRM Comment Period End 12/31/2018 NPRM 11/00/2019 Undetermined Federal State No No Yes Hillary Cavanagh Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-6574 hillary.cavanagh@cms.hhs.gov Center for Medicare and Medicaid Innovation, 7500 Security Boulevard, Baltimore MD 21244