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

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

On February 24, 2022, the Centers for Medicare & Medicaid Services (CMS) announced its redesign of the Global and Professional Direct Contracting Model (GPDC), which now will be called the Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model.
Continue Reading “REACHing” For Health Equity: CMS Revamps The Global And Professional Direct Contracting Model

On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Per CMS, the Proposed Rule will reduce out-of-pocket prescription drug costs, improve price transparency and market competition under the Part D program, strengthen consumer protections to ensure Medicare Advantage (“MA”) and Part D beneficiaries have accurate and accessible information about their health plan choices and benefits, strengthen CMS oversight of MA and Part D plans, and improve the integration of Medicare and Medicaid programs for individuals enrolled in dual eligible special needs plans (“D-SNPs”). CMS failed to mention that the Proposed Rule will also result in additional administrative burdens and increased costs for MA organizations (“MAOs”) and Part D sponsors.

Continue Reading CMS’s Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

On August 13, 2021, the D.C. Circuit Court of Appeals reversed a district court opinion vacating CMS’ Overpayment Rule, 42 C.F.R. 422.326, for Medicare Advantage organizations (“MAOs”).  UnitedHealthcare Insurance Co. et al. v. Becerra et al., case number 18-5326.  As a result of this decision, CMS can once again rely on the Overpayment Rule to impose voluntary refund obligations for MAOs.  MAOs – already subject to significant government enforcement related to their risk adjustment coding practices – should carefully consider the implications of this decision for their coding and auditing practices.

Continue Reading D.C. Circuit Gives New Life to CMS Overpayment Rule

The Biden Administration used the annual rulemaking that governs health plans sold on the Affordable Care Act’s exchanges to lower health care costs for consumers and improve access to health care. Part 2 of the Notice of Benefit and Payment Parameters for 2022 Final Rule (the Payment Notice), issued April 30, 2021, is the second in a series of rulemakings addressing exchange plans.[1]  The Department of Health and Human Services (HHS) anticipates additional rulemakings on the 2022 Payment Notice later this year.[2] The rulemaking announced changes to out-of-pocket costs, special enrollment periods, risk adjustment, and HHS’s audit and oversight of exchanges, among other things.

Continue Reading Biden Administration Finalizes Lower Out-of-Pocket Costs for Exchange Plans, Targets Health Equity and Access

On March 4th, the U.S. District Court for the District of Maryland struck down four provisions of the Trump Administration’s Notice of Benefit and Payment Parameters for 2019, 83 Fed. Reg. 16930 (April 17, 2018) (the “Rule”), which governs many aspects of Affordable Care Act (“ACA”) insurance markets beginning in the 2019 plan year.  The decision in City of Columbus, et al. v. Norris Cochran comes two and a half years after the cities of Columbus, Baltimore, Cincinnati, Chicago, and Philadelphia, as well as two individuals who rely on health insurance offered on ACA exchanges, filed suit alleging that the actions of the U.S. Department of Health and Human Services (“HHS”) drove up premiums, made enrollment more difficult, and caused more people to go without affordable, high-quality health insurance.
Continue Reading Federal Court Decides ACA “Sabotage” Case

On February 26, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued Frequently Asked Questions (FAQs) on the implementation of the Families First Coronavirus Response Act (“FFCRA”), the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), and other health coverage issuesrelated to COVID-19.

Continue Reading New Guidance on Health Plans’ COVID-19 Coverage Obligations

On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the “Final Rules”), which require non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets to disclose certain information including negotiated rates with providers and estimated out-of-pocket expenses to enable consumers to make informed health care purchasing decisions.
Continue Reading Trump Administration Finalizes The Transparency in Coverage Rule

On September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued the Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part I, CMS-HCC Risk Adjustment Model (the “Advance Notice”).  CMS is issuing the Advance Notice in two parts: Part I includes key information about the Medicare Advantage CMS-Hierarchical Condition Categories (“HCC”) risk adjustment model and the use of encounter data for CY2022.  Part II, which will include other changes to the CY2022 payment methodologies, will be issued later this Fall.   CMS will announce the CY2022 MA capitation rates and final payment policies no later than Monday, April 5, 2021.
Continue Reading CMS Issues the 2022 Medicare Advantage Advance Notice Part I – Risk Adjustment