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Christine Clements is a partner in the Governmental Practice and a Co-Managing Partner of the firm’s Washington, D.C. office. She is also a Deputy Team Leader of the firm’s Healthcare Team.

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other changes, this Final Rule will allow CMS to audit a sample of an MA organization’s (“MAO”) diagnoses reported for risk adjustment purposes (from 2018 and later) and then use the audit findings to calculate an extrapolated improper payment amount for the MAO’s contract. This extrapolation technique is controversial for a number of reasons, including whether CMS has the authority to use it in the manner proposed in the Final Rule, and whether it is an actuarially sound method of auditing. As we predicted in February, this Final Rule is now being challenged in court.Continue Reading Medicare Advantage RADV Audit Final Rule Challenged in Court

The status of the independent dispute resolution (IDR) process under the No Surprises Act (NSA) is ever-evolving. Providers are waiting on the sidelines as cases weave their way through the court system. While the IDR process is currently on hold, it is incumbent on providers, payors, and individuals to remain vigilant and stay abreast of the forthcoming changes.Continue Reading Sheppard Mullin Webinar – No Surprises Act: Litigation Update and Recent Guidance

The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the guidance documents issued by the Centers for Medicare and Medicaid Services (“CMS”) detailing the proposed implementation of the Medicare Part B and Medicare Part D Prescription Drug Inflation Rebate Programs.Continue Reading CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”) and Medicare Part D (“Part D”) Prescription Drug Inflation Rebate Programs (each, a “Rebate Program” and, collectively, the “Rebate Programs”). The Rebate Programs are administered as part of the prescription drug affordability provisions of the Inflation Reduction Act (the “IRA”), which is aimed at “lower[ing] out-of-pocket drug costs for people with Medicare and improv[ing] the sustainability of the Medicare program for current and future generations.”[1] The IRA represents the most sweeping healthcare legislation passed by Congress since the Affordable Care Act.[2] Please refer to our previous blog post on the IRA.Continue Reading CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”). CMS promotes the Final Rule as improving program integrity and payment accuracy as well as transparency and certainty. One thing that is certain, CMS can expect further challenges to its RADV audit methodology.Continue Reading CMS Issues Long-Awaited Medicare Advantage RADV Final Rule

Social determinants of health (“SDOH”) consider the non-clinical factors that can profoundly impact an individual’s well-being. They are extensive and often overlap, including housing instability, food insecurity, the inability to afford and obtain medications and more. Research has indicated that healthcare systems that connect patients to basic resources have observed improvements in population health metrics, fostered trust with their patient base, and experienced reduced hospitalization costs.Continue Reading CMS Augments “In Lieu Of Services” Medicaid Guidance to Support State Medicaid Managed Care Efforts to Address Social Determinants of Health

Introduction

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic

Continue Reading Key Healthcare Provisions of the Consolidated Appropriations Act, 2023

Just in time for the holidays, the Centers for Medicare and Medicaid Services (“CMS”) issued the Contract Year 2024 Proposed Rule for Medicare Advantage organizations (“MAOs”) and Part D sponsors (the “Proposed Rule”). The Proposed Rule includes changes on an array of topics including: Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, behavioral health services, identification of overpayments, requirements for valid contract applications, and formulary changes. Continue Reading CMS Issues CY2024 Proposed Rule for Medicare Advantage Organizations and Part D Sponsors