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Christine Clements is a partner in the Governmental Practice in the firm's Washington, D.C. office and a member of the firm's Healthcare Team.

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

The Centers for Medicare and Medicaid Services (“CMS”) has issued a proposed rule which would amend the existing regulations for reporting and returning identified overpayments (the “Proposed Rule”). Specifically, with respect to the meaning of “identification” of overpayment, CMS proposes to eliminate the “reasonable diligence” (or traditional negligence) standard and replace it with the False Claims Act’s (“FCA’s”) standard of “knowing” and “knowingly” (i.e., reckless disregard or deliberate ignorance of a potential overpayment).

Continue Reading CMS Proposes to Amend Overpayment Rule, Remove Potential Overpayment and False Claims Act Liability for Mere Negligence

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Advancing Interoperability and Improving Prior Authorization Processes” (the “Proposed Rule”), that is intended to improve patient and provider access to health information and streamline processes related to prior authorization for medical items and services. The Proposed Rule would withdraw CMS’s December 18, 2020 Interoperability and Prior Authorization proposed rule, build on the policies finalized in the agency’s May 1, 2020 Interoperability and Patient Access final rule, and incorporate feedback CMS received from commenters on the December 2020 proposed rule.

Continue Reading CMS Includes MAOs in Data Exchange and Prior Authorization Requirements

On Monday, we discussed that the Centers for Medicare and Medicaid Services (“CMS”) has heightened oversight of Medicare Advantage (“MA”) organizations’ and Part D sponsors’ marketing practices. We also noted that the United States Senate Committee on Finance (the “Committee”) sent letters to 15 state insurance commissioners and state health insurance assistance programs, requesting data and information on MA marketing complaints in August 2022. Yesterday, the Committee, chaired by Ron Wyden, released a report entitled Deceptive Marketing Practices Flourish in Medicare Advantage (“the Report”).

Continue Reading Senate Committee Issues Report On Deceptive Marketing Practices in Medicare Programs

CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs).

Continue Reading CMS Pushes Publication of Final FFS Adjuster for RADV Audits Rule to February 1, 2023

In May, we discussed the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”) issued by the Centers for Medicare and Medicaid Services (“CMS”). In the Final Rule, CMS established certain marketing and communication requirements for Medicare Advantage (“MA”) organizations and Part D prescription drug sponsors (PDPs), intending to address complaints of inappropriate marketing that indicated it CMS received from beneficiaries and their caregivers.

Continue Reading CMS Heightens Oversight of TPMO Marketing Programs, Restricts TV Advertisements