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On April 4, 2024, CMS released the unpublished PDF version of the Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F). The Final Rule contains numerous new requirements that were not included in the proposed rule from November 2023, expanding the rule to 1,327 pages. CMS dusted off a lot of earlier proposals and finalized them for 2025. Here is the initial unpublished PDF. It is scheduled to be published in the Federal Register on April 23, 2025.

Elizabeth Lippincott (co-presenter) at AHLA Institute on Medicare and Medicaid Payment Issues on March 21, 2024.

Elizabeth Lippincott and Sandra Durkin (Co-presenters) at the 2024 HCCA Managed Care Compliance Conference on January 29, 2024.

The CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) includes a series of changes meant to streamline prior authorization and advance interoperability. Impacted payors include Medicare Advantage (MA) organizations, state Medicaid and CHIP Fee-For-Service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally Facilitated Exchanges. Most of the Final Rule’s changes become effective in 2026, with the new API standards generally going into effect in 2027.

Elizabeth Lippincott will be speaking at the AHLA Institute on Medicare and Medicaid Payment Issues on March 21, 2024 I Baltimore, Maryland.

In recent years, sustained oversight and enforcement by the federal government has made risk adjustment (RA) a top compliance priority for Medicare Advantage (MA) organizations. Complete and accurate coding of member conditions is critical for MA plan success. A plan that undercodes (fails to capture member conditions that impact treatment) will not have sufficient resources to manage the care of its members, while a plan that overcodes (submits unsupported diagnoses to the government) faces potentially devastating legal risk.

FDA released guidance adjusting its approach to promotion of off-label uses for approved products. Though manufacturers have long been prohibited from distributing products for unapproved uses or engaging in off-label promotion, the new guidance, released on October 24, allows manufacturers to share with health care providers (HCPs) certain truthful and non-misleading scientific information on unapproved uses (SIUU) of approved medical products that may be useful for providers. Though off-label promotion and distribution remain verboten, the new draft guidance expands manufacturers’ ability to engage in scientific communications with HCPs.

Elizabeth Lippincott (co-presenter) at ACI’s 2nd Annual Legal, Regulatory, and Compliance Summit for Medicare Advantage on November 2, 2023.

The Inflation Reduction Act's (IRA) novel and controversial drug pricing negotiation program is being challenged in at least seven lawsuits, including some from manufacturers of drugs selected to undergo the negotiation process. The challenged program requires manufacturers to negotiate prices with the government for select drugs covered by Medicare Parts B and D. Among other things, challengers argue that the program violates the First and Fifth Amendments.

Elizabeth Lippincott and Sandra Durkin presented at the 2023 Blue Cross Blue Shield Lawyers Conference.