Healthcare Law Blog

Shaping the World of Healthcare Law

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
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
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

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

Executive Summary

The California Department of Managed Health Care (“DMHC”) issued a recent guidance interpreting the application of the No Surprises Act (“NSA”)—a new federal law prohibiting out-of-network healthcare providers from balance-billing patients for certain emergency and non-emergency services—in California.  Significantly, when determining which payment and dispute resolution processes will apply in a dispute regarding the value of non-contracted emergency and non-emergency services, the NSA expressly defers to existing state law which already protects patients from receiving “surprise” medical bills, as long as such state laws conform to certain requirements set forth in the NSA.  The NSA refers to such
Continue Reading DMHC Guidance Confirms that California Law, Not the Federal No Surprises Act, Governs Payment and Dispute Resolution Processes for Certain Out-of-Network Services Provided in California

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022. The updates are part of a concerted effort by the medical device industry to respond to recent regulatory guidance and health industry trends. Below are 7 things that you need to know about these latest modifications.
Continue Reading 7 Things to Know About the New AdvaMed Code Updates

As of April 11, 2022, the Health Resources & Services Administration (“HRSA”) is now offering providers who missed the original Provider Relief Fund (“PRF”) reporting deadlines the opportunity to request the ability to report in compliance with the PRF Terms and Conditions. Request submissions for Reporting Period 1 are due by Friday, April 22, 2022.
Continue Reading Alert to Providers: Another Shot to Comply with Provider Relief Fund Reporting Requirements

On April 1, 2022, the Centers for Medicare & Medicaid Services (“CMS”) announced states may seek to extend Medicaid postpartum coverage from 60 days to one year through a new state plan option offered by the American Rescue Plan Act (“ARPA”). The new state plan option allows state Medicaid and Children’s Health Insurance Program (“CHIP”) agencies to provide 12 months of continuous postpartum coverage, regardless of any changes in circumstances, through a state plan amendment (“SPA”). This option is available for five years and ends on March 31, 2027.
Continue Reading CMS Begins Option to Extend Medicaid Postpartum Coverage

Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger insurers. Last week the Fifth Circuit issued an opinion in one of those cases, affirming the lower court’s rulings in favor of the United States Department of Health and Human Services (HHS) and its administration of the risk-adjustment program. See Vista Health Plan, Inc. v. United States Dep’t of Health & Hum. Servs., No. 20-50963, 2022 WL 807554, at *1 (5th Cir. Mar. 17, 2022).
Continue Reading Fifth Circuit Upholds ACA Risk Adjustment Program

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 Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). This is the third AO in a recent series of AOs (see AO 21-17 on November 19, 2021 and AO 21-13 on October 4, 2021) focused on Medicare cost subsidies in a clinical trial setting for serious conditions that affect large portions of the population in the US. Like these other
Continue Reading OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

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

Texas HB 1445, which went into effect on January 1, 2022, exempts medical billing services performed before the submission of the relevant insurance claim from state sales tax. The new legislation legally exempts medical billing services from the statutory definition of taxable “insurance services.” Practically speaking, this relieves management services companies, and ultimately physicians and patients, from bearing the burden of tax payments of up to 8.25% for the provision of certain medical billing services. The legislation is hailed by many as a meaningful step in lowering needlessly high healthcare costs, which are felt by patients and providers alike.
Continue Reading Tax Break for Certain Medical Billing Services in Texas

In our November 9, 2021, blog post on the No Surprises Act (“NSA”), we discussed new consumer protections against surprise out-of-network bills. In addition to protecting insured consumers from balance billing, the NSA protects uninsured (or self-pay) individuals from many unexpectedly high medical bills. Specifically, effective January 1, 2022, a provider must furnish a self-pay patient with notice and a good faith estimate (“GFE”) of the cost of care prior to all scheduled services. This includes, among other things, a GFE of the cost of office visits, therapies, diagnostic tests, infusions, surgeries and any services reasonably expected to be provided
Continue Reading Q&A: The No Surprises Act’s Protections for Uninsured (or Self-Pay) Individuals