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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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CMS Finalizes Permanent Changes for Certain Telehealth Services Modified During COVID-19 Public Health Emergency

Time to Read: 1 minutes Practices: Health Care

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On December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the annual Physician Fee Schedule Final Rule (“Final Rule”). Among other things, the Final Rule:

  • Makes permanent certain changes that CMS had put in place since the declaration of the public health emergency for the COVID-19 global pandemic (“PHE”) that modified coverage of telehealth services in the Medicare program;
  • Adds certain services permanently to the list of telehealth services covered by Medicare (“Medicare Telehealth Services List”);
  • Reduces, on a permanent basis, frequency limitations on nursing facility services delivered through telehealth;
  • Removes an outdated and, due to the existence of smartphones, confusing reference to “telephones” in the definition of interactive telecommunications system;
  • Makes permanent certain flexibilities that CMS had granted during the PHE related to remote monitoring care management services and virtual Communication Technology-Based Services (“CTBS”) based on CMS’ determination that these are not considered telehealth services; and
  • Clarifies several payment policies related to remote physiologic monitoring (“RPM”) services.

The Final Rule’s regulations became effective on January 1, 2021, though select policies will be applicable retroactive to January 1, 2020, or from the start of the PHE on January 27, 2020. For a discussion of the proposed rule and prior modifications to telehealth services during the PHE, please see Ropes & Gray’s prior Alert.

This Alert summarizes key telehealth changes made by the Final Rule, and includes a table for quick reference.

Click here to read the full Alert.

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