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Xavier Baker is a partner in the Corporate Practice Group in the Washington, D.C. office and member of the firm's Healthcare team.

On January 5, 2022, we discussed the Notice of Benefit and Payment Parameters for 2023 proposed rule released by the Centers for Medicare & Medicaid Services (CMS). On April 28, 2022, CMS issued the NBPP 2023 Final Rule. CMS published a Fact Sheet and other resources on April 28, 2022. The rule will take effect on January 1, 2023, but the optional early bird application deadline is May 18, 2022 and the final deadline for issuers to submit changes to their QHP Application is August 17, 2022.
Continue Reading 2023 Payment Rule’s Nondiscrimination Provisions and Anticipation of New Section 1557 Rules

More than 13 million people were enrolled in Medi-Cal in California in September 2021, making it the largest Medicaid program in the nation. In December 2021, the Centers for Medicare & Medicaid Services (CMS) approved the California Department of Health Care Services’ (DHCS’) request for a five-year extension of its Medicaid section 1115 demonstration and a five-year extension of its Medicaid managed care section 1915(b) waiver. These Medicaid waivers are part of the “California Advancing and Innovating Medi-Cal” (CalAIM) initiative which was launched in January 2022 to provide aid to California’s most vulnerable residents and to provide more equitable programs and access statewide.
Continue Reading Medicaid and Health Equity: CalAIM’s Bold Experiment

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

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s intent to advance health care equity and racial justice in the United States by minimizing the influence of the social determinants of health. The Executive Order mobilized 90 federal agencies and 50 independent agencies to evaluate and implement action plans to reduce systemic barriers to access.[1] On April 14, 2022, the U.S. Department of Health and Human Services (HHS), published the HHS Equity Action Plan (Action Plan).
Continue Reading The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

Last month, a three-judge panel in the Ninth Circuit reversed the Northern District of California’s ruling in Wit v. United Behavioral Health. In Wit, the district court ruled that United Behavioral Health (“UBH”) breached its fiduciary duties under ERISA to insureds by denying their mental health and substance use disorder claims as a result of allegedly pervasively flawed medical necessity criteria that the court concluded are not consistent with generally accepted standards of care (“GASC”). The district court ordered UBH to reprocess over 60,000 claims.
Continue Reading Less is More: Brevity is the Soul of Wit

On January 25, the U.S. Department of Labor (DOL), Department of Health and Human Services (HHS), and the Treasury (collectively the Tri-Agencies) published the first annual report on group health plans’ and health insurance issuers’ compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA) as amended by the Consolidated Appropriations Act, 2021 (CAA). The Report noted that none of the comparative analyses reviewed “contained sufficient information upon initial receipt.” The Tri-Agencies made preliminary determinations of non-compliance for many plans and issuers, but the Report stressed that no final determinations had been made yet. Instead, plans and issuers may still take corrective action and, in so doing, avoid the triple-whammy of being named in next year’s report, having notice of noncompliance sent to plan participants and enrollees (essentially rolling out a red carpet for class action litigation), and the Tri-Agencies notifying the state regulator. Plans and issuers should not count on the Tri-Agencies exercising such restraint in the future.
Continue Reading Tri-Agencies Report MHPAEA Compliance Lacking, But Don’t Name and Shame Plans and Issuers . . . Yet

On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. As first announced by President Biden on December 2, 2021, the Biden Administration explained that health plans and health insurance issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. The Administration directed the Tri-Agencies to issue guidance by January 15, 2022 detailing how to effectuate this expanded coverage of COVID-19 diagnostic testing. Yesterday, the Tri-Agencies published FAQ 51 which requires health plans and health insurance issuers to cover no less than 8 tests per 30-day period per individual beneficiary beginning January 15, 2022.
Continue Reading Tri-Agencies Release Guidance on Coverage of OTC COVID-19 Tests

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

Today HHS published the Notice of Benefit and Payment Parameters for 2023 proposed rule in the Federal Register. The annual rulemaking details changes to qualified health plans (“QHPs”), QHP issuers, and the ACA’s exchanges including:

Continue Reading Back to the Future: 2023 Payment Rule Would Revert Nondiscrimination and Guaranteed Availability Provisions to Pre-Trump Forms, Returns Standardized Plan Options

Six months ago, we cautioned health plans and plan sponsors that states, the federal government, and private litigants were laser focused on Mental Health Parity and Addiction Equity Act (“MHPAEA”) compliance. The United States Department of Labor (“DOL”) investigated and closed 127 health plan investigations related to MHPAEA in FY 2020. Given the changes announced in the Consolidated Appropriations Act, 2021 (“CAA”), and subsequent guidance, we expect heightened scrutiny of MHPAEA compliance from states, the federal government, and private parties.
Continue Reading State, Federal, and Private Enforcement of Mental Health Parity Compliance

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021 (CAA) received a welcome reprieve via guidance published August 20. The Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments) announced that they would exercise enforcement discretion and defer enforcement of requirements that plans and issuers publish machine-readable files for in-network rates and out-of-network allowed amounts and billed charges until July 1, 2022 instead of January 1, 2022. The Departments also explained that they would reconsider whether the TiC Final Rule’s requirement to publish negotiated rates and historical net prices for covered prescription drugs in a machine-readable file remains appropriate given the subsequent enactment of the provisions in the Division BB, Title II—Transparency of the Consolidated Appropriations Act, 2021, which requires plans and issuers to report similar prescription drug pricing information to the Departments by December 27, 2021.
Continue Reading Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings