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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 Though off-label promotion and distribution remain verboten, the new draft guidance expands manufacturers’ ability to engage in scientific communications with HCPs.

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 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. 

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.

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.

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.”

Last Friday, CMS took a three-month extension to finalize the 2018 proposed rule that would have revised Risk Adjustment Data Validation (RADV) regulations to make it easier for the government to recoup overpayments to Medicare Advantage (MA) organizations, including use of extrapolation based on the error rates in audit samples.

On October 19, 2023, CMS released FAQs on the updated marketing requirements that are in place this annual open enrollment season. CMS clarified its expectations under the regulations for third party marketing organizations (TPMOs).