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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.

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

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. Overall, the healthcare provisions of the IRA reflect the Administration’s goal of expanding the accessibility of healthcare to individuals by reducing costs to beneficiaries and capping charges by drug manufacturers. Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation.Continue Reading Healthcare Reforms Under the IRA: Expanding Access to Care

Assembly Bill 2080[1] (“AB 2080”), known as the “Health Care Consolidation and Contracting Fairness Act of 2022,” was approved by the California Assembly on May 26, 2022, and if passed by the Senate and signed into law before the August 31st recess, will significantly affect healthcare M&A activity in California for a broad spectrum of healthcare providers, payors and other stakeholders.[2] Continue Reading Putting the Brakes on Healthcare M&A and Provider/Payor Contracting: AB 2080 Poised to Dramatically Impact Healthcare Transactions in California

On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”).  CMS promotes the Final Rule as advancing “CMS’ strategic vision of expanding access to affordable health care and improving health equity in Medicare Advantage (MA) and Part D through lower out-of-pocket prescription drug costs and improved consumer protections.”  With a few exceptions, the Final Rule is a wholesale codification of the proposed rule. Except as noted below, the requirements of the Final Rule are effective January 1, 2024.
Continue Reading CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors

Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage

On March 2, 2022, the Department of Health and Human Services (“HHS”) Office of the Inspector General (the “OIG”) issued a new advisory opinion (“AO 22-04”) related to a program through which the Requestor would provide certain individuals access to digital contingency management (“CM”) and related tools to treat substance use disorders (“Program”).  The OIG advised that it would not impose administrative sanctions under the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty Law (“CMPL”).
Continue Reading HHS OIG Signs Off on Substance Use Recovery Incentive Program