New DOJ Whistleblower Program for Commercial Fraud Reports
On August 1, 2024, the U.S. Department of Justice (DOJ) introduced its Corporate Whistleblower Awards Pilot Program, a three-year program designed to fill gaps in federal agency whistleblower programs. A key function of this new program is to bolster enforcement of misconduct that is not prosecutable under the False Claims Act (FCA). The FCA only imposes liability for fraud against the federal government, which creates a gap in enforcement for fraud against other organizations or individuals. The Whistleblower Pilot Program targets misconduct against non-federal government organizations or individuals, such as private payors or patients.
CMS Updates ODAG/CDAG Guidance for MA and Part D Plans
On July 18, 2024, the Centers for Medicare & Medicaid Services (CMS) published an update to the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance (Updated Guidance). CMS had not updated guidance for organization determinations, appeals, and grievances (ODAG) in the Part C program and coverage determinations, appeals and grievances (CDAG) in the Part D program since 2019. The Updated Guidance reflects recent changes to the regulations governing ODAGs, clarifications on the role of representatives in the ODAG/CDAG process, and terminology changes to align with updated regulations.
The Regulatory Pendulum Is in Full Swing for Medicare Plans: Five Things You Can Count on in a Dynamic Regulatory Environment
The pendulum of the Medicare plan regulatory environment—which grew increasingly stringent under the Biden administration—probably reached its amplitude in the last few weeks and began to swing in the opposite direction. Having seen several oscillations of this political pendulum, I wanted to share some insights about what these changes mean for Medicare plans, as well as what lawyers and business teams can count on to stay constant.
BREAKING NEWS
A Texas District Court has stayed the implementation of the Medicare Advantage and Part D agent compensation provisions of the CY 2025 Final Rule for all affected parties.
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On April 4, 2024, CMS released the unpublished PDF version of the Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F).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.
