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Latest News2021-05-19T18:39:49+00:00
2111, 2023

Recent Cigna Settlements Increase Compliance Stakes for MA Organizations’ Risk Adjustment Programs

November, 2023|

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.

1411, 2023

FDA Releases New Draft Guidance on Off-Label Communications

November, 2023|

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 Though off-label promotion and distribution remain verboten, the new draft guidance expands manufacturers’ ability to engage in scientific communications with HCPs.

1909, 2023

Life Sciences Industry Challenges Drug Price Negotiation Program

September, 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.

1007, 2023

Elizabeth Lippincott will be Co-Chair of ACI’s 2nd Annual Legal, Regulatory and Compliance Summit on Medicare Advantage

July, 2023|

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. 

1711, 2022

Part B Drug Cost Sharing Adjustments Required for Medicare Advantage Plans in 2023

November, 2022|

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.”

1209, 2022

Elizabeth Lippincott will Co-Chair and speak at American Conference Institute’s (ACI) Legal, Regulatory and Compliance Summit on Medicare Advantage

September, 2022|

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." 

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