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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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Do You Know Where Your Tax-Exempt Bond Records Are?


Time to Read: 1 minutes Practices: Health Care

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On August 21, the IRS issued its long-awaited tax-exempt bond financings “compliance check questionnaire,” which has reportedly been mailed to hundreds of tax-exempt borrowers across the country, including universities, hospitals, and cultural organizations.

As anticipated, the questionnaire seeks detailed information about a borrower’s record-keeping and compliance assurance practices. For a copy of our previous Client Alert about this matter, which encouraged the adoption of an appropriate record-keeping policy, click here. If you have not yet adopted such a policy, you may wish to consider doing so at this time.

Why does this matter? Tax-exempt bonds are subject to post-closing operational requirements until the bonds are redeemed, such as limitations on “private use” of bond-financed property. The IRS has the authority to revoke retroactively the tax-exempt status of bonds issued on behalf of any borrower that fails to comply with these requirements. Any threatened or actual revocation of the tax-exempt status of a non-profit organization’s bonds may have a material, adverse effect on that organization’s access to and cost of capital, in addition to the expense of defending against such action and potential penalties.

How to find out more: On September 7, 2007, Ropes & Gray will review the questionnaire and suggest compliance strategies in an educational teleconference.

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For further information, please contact your usual Ropes & Gray lawyer.

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