Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of the services of a clinical laboratory. The law, however, leaves key terms undefined, including “referral”, “patronage”, and “use of services.” This ambiguity leaves unclear exactly which forms of conduct are prohibited by EKRA. Further, EKRA contains exceptions that overlap imperfectly with safe harbors under the Anti-Kickback…
Continue Reading California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to Physicians

In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws more generally. In Xiulu Ruan v. U.S., No. 20-1410 (Jun. 27, 2022), the Court considered the convictions of two physicians for violating the Controlled Substances Act, 21 U.S.C. § 841 because, DOJ contended, and the respective juries found, that their prescriptions were “not authorized.” (The relevant statute makes it a federal crime to “[e]xcept as authorized[,]….knowingly or intentionally…dispense…a controlled substance.” Id.). One…
Continue Reading Supreme Court Rules for Physicians in Blow to DOJ

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving physician-ownership of a medical device company. The opinion identified six characteristics of the arrangement which greatly reduced the risk of fraud and abuse.
Continue Reading OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of the Health Insurance Portability and Accountability Act (“HIPAA”) in connection with the provision of telehealth services. In effect, a covered health care provider seeking to use audio or video communication technology to provide telehealth services during the public health emergency could do so with greater…
Continue Reading Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services

On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program (“340B Program”).
Continue Reading Supreme Court Saves Hospitals from $1.6B Cut to 340B Program

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by individuals via the Internet. Individuals generally enter the metaverse through the following four technologies: virtual reality, augmented reality, mixed reality and extended reality.  …
Continue Reading Digital Health in the Metaverse: Three Legal Considerations

Last month, in Cummings v. Premier Rehab Keller, P.L.L.C., the Supreme Court denied a petitioner’s right to emotional distress damages in a private action brought under federal anti-discrimination laws. The Petitioner, a woman who is both deaf and legally blind, alleged that when she requested an American Sign Language interpreter at Premier Rehab Keller (“Premier”), the clinic denied her request, resulting in her inability to receive treatment. She filed suit under Section 504 of the Rehabilitation Act (“Rehab Act”) and Section 1557 of the Affordable Care Act (“ACA”), two federal statutes that prohibit recipients of federal funding from discriminating in…
Continue Reading Supreme Court Discrimination Case Narrows Scope of Restitution for Individuals

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