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CMS Issues Proposed Rule to Revise Medicare Parts C and D Regulations

Client Alert | 1 min read | 10.07.11

On October 3, 2011, the Centers for Medicare & Medicaid Services (CMS) released on the Federal Register's Electronic Public Inspection Desk a new proposed rule designed to implement revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) regulations. The revisions address a number of goals, namely: "to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." In addition, CMS is considering revisions to the long term care facility conditions of participation requirements for pharmacy services. Comments on the proposed rule will be due 60 days after publication in the Federal Register, which has been slated for Tuesday, Oct. 11. Among the revisions considered, highlights include:

  • Implementation of Affordable Care Act with regard to the consolidation of prior guidance on the Coverage Gap Discount Program and implementation of Pharmacy Benefit Manager reporting requirements under Part D;
  • Implementation of MIPPA provision related to benzodiazepines and barbiturates as Part D drugs;
  • Provisions for beneficiary reinstatement into cost plans when good cause for failure to pay premiums can be established;
  • Provision of uniform ID cards for MA plan enrollees and guidance related to the determination of creditable coverage for the retiree drug subsidy;
  • A process for Independent Review Entity (IRE) reconsideration of Part D coverage determinations;
  • Procedures and standards for the exclusion of poor performers in the Parts C and D programs;
  • Measures to reduce costs, including the elimination of the requirement to purchase print advertising announcing non-renewal of cost contractors, implementation of hospital-acquired conditions and present-on-admission indicator policy for MA plans, changes to rules regarding agent/broker compensation, and cost-sharing associated with trial fills of prescription drugs;
  • And further codification and clarification of prior guidance under Parts C and D.

Insights

Client Alert | 2 min read | 06.12.25

IPR May Be Discretionarily Denied Because of “Settled Expectations” Where Petitioner Has Long Known of Challenged Patent

Acting USPTO Director Coke Morgan Stewart issued a Director Discretionary decision on June 6, 2025, in iRhythm Technologies Inc. v. Welch Allyn Inc., IPR2025-00363, -00374, -00376, -00377, and -00378 Paper 10 (PTAB June 6, 2025). This decision granted Patent Owner’s request for discretionary denials of institution in five related IPR challenges.  It follows several recent Director decisions that have all discretionarily denied petitions for reasons other than the substantive merits of the challenges. However, this decision is the first one that relies upon “[s]ettled expectations of the parties, such as the length of time the claims have been in force,” a new consideration that was first articulated in the USPTO’s “Interim Process for PTAB Workload Management” memorandum (“Interim Memo”) dated March 26, 2025....

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