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.”
CMS Buys More Time to Finalize MA Risk Adjustment Rule
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.
CMS Issues Medicare Advantage Marketing FAQs
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).
Elizabeth Lippincott will Co-Chair and speak at American Conference Institute’s (ACI) Legal, Regulatory and Compliance Summit on Medicare Advantage
October 12- 13, 2022 Nashville, Tennessee Elizabeth Lippincott will co-chair and speak at ACI’s Legal, Regulatory and Compliance Summit on Medicare Advantage from October 12-13, 2022, in Nashville, Tennessee. Elizabeth’s co-chair is Karen Lam of Kaiser Permanente. Elizabeth will be presenting alongside Teresa A. Mason of Epstein Becker Green and Julie Nielsen of Berkeley Research Group discussing "Risk Adjustment: Forecasting the Future of Enforcement and the Implications for the Compliance and Legal Landscape."
Top of Mind Tuesday: Congress Passes Bill with Major Implications for Medicare Plans
The Senate and House of Representatives voted to pass the Inflation Reduction Act (IRA), a major budget bill impacting environmental, tax, and health policy, which is expected to be signed into law shortly. The bill contains numerous changes relevant to Medicare and the ACA, but most notably for Medicare prescription drug plans, the IRA will allow Medicare to negotiate prescription drug prices for a limited number of medications.
Top of Mind Tuesday: New Third-Party Marketing Requirements for Medicare Advantage
CMS published new marketing and communications requirements, which went into effect June 28, 2022, impacting Medicare Advantage (MA) organizations. The new requirements are intended to address beneficiary complaints associated with third-party marketing organizations (TPMOs), as well as feedback from beneficiary advocates and stakeholders concerned about the marketing practices of TPMOs that sell multiple MA and Part D products.
