2025 MA and Part D Final Rule Released
On April 4, 2024, CMS released the unpublished PDF version of the Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F).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 Here is the initial unpublished PDF.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.
CMS Interoperability and Prior Authorization Final Rule Impacts for MA
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 Presenting at the AHLA Institute on Medicare and Medicaid Payment Issues
Elizabeth Lippincott will be speaking at the AHLA Institute on Medicare and Medicaid Payment Issues on March 21, 2024 I Baltimore, Maryland.
Recent Cigna Settlements Increase Compliance Stakes for MA Organizations’ Risk Adjustment Programs
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FDA Releases New Draft Guidance on Off-Label Communications
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.
Life Sciences Industry Challenges Drug Price Negotiation Program
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 will be Co-Chair of ACI’s 2nd Annual Legal, Regulatory and Compliance Summit on Medicare Advantage
Elizabeth Lippincott will co-chair and speak at ACI’s 2nd annual Legal, Regulatory and Compliance Summit on Medicare Advantage from November 2-3, 2023 in Nashville, Tennessee. Elizabeth’s co-chairs are Karen Lam of Kaiser Permanente and Annie Shieh of Bright Health Group.
Implementing New CMS Translation Requirements for CY 2024 – UPDATED*
On April 12, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule revising translation and accessibility requirements for Medicare Advantage and Part D materials. The final rule includes expanded availability of translated and accessible materials.
Summary of CY 2024 Proposed Rule for Medicare Advantage Organizations and Part D Sponsors
CMS released the CY 2024 Proposed Rule for MA and Part D sponsors on December 14, 2022, making significant changes to Medicare Advantage and Part D regulations.
Part B Drug Cost Sharing Adjustments Required for Medicare Advantage Plans in 2023
The Inflation Reduction Act provisions mandating adjustments to cost sharing for Part B drugs subject to inflationary rebates were silent on the question of whether Medicare Advantage (MA) plans would need to adjust coinsurance for drugs subject to inflationary rebates for the previous quarter. On November 7, 2022, however, CMS released a memorandum titled, “Inflation Reduction Act Changes to Cost Sharing for Part B Drugs for Contract Year 2023 Medicare Advantage and Section 1876 Cost Plans.”
