Health Care Counsel Blog

On June 21, 2022, the Supreme Court concluded, in Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641, 2022 WL 2203328 (U.S. June 21, 2022), that the terms of a benefit plan limiting reimbursement for dialysis treatment did not violate the MSP Act.

CMS recently imposed Civil Monetary Penalties against two Georgia hospitals for failing to comply with the 2021 Price Transparency Rule, which requires hospitals to publish the standard costs of their items or services on a public website. 

The concept of “administrative deference” is a key component to the modern regulatory state. An important aspect of administrative deference is the “Chevron doctrine,” i.e. the concept that the courts should defer to relevant agencies’ interpretations of ambiguous statutes.

The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022.

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an Alert addressing many of the inquiries we have received.

The metaverse is widely regarded as the next frontier in digital commerce, with businesses across all industries spending millions of dollars to acquire a digital presence for positioning as market leaders.

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions.

The metaverse is widely regarded as the next frontier in digital commerce, with businesses across industries spending millions of dollars to position themselves as market leaders. While it offers clear opportunities for businesses, the metaverse also presents unique legal challenges.

The HHS Office for Civil Rights is requesting comments about HIPAA covered entities’ and business associates’ implementation of “recognized security practices” and payments to “harmed individuals” from funds the agency collects from its enforcement actions. Stakeholders have until June 6, 2022.

Comments sought regarding the permissibility of messages relating to Medicaid and other health coverage programs.

The FCC is seeking comment on a request for clarification submitted by the Department of Health and Human Services related to TCPA compliance for certain healthcare messages.

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the Requestor’s provision of free genetic testing and counseling.

In Scheer v. Regents of the University of California, the Second District Court of Appeal held that the McDonnell-Douglas burden-shifting framework applies to claims asserted pursuant to Health & Safety Code Section 1278.5.

Constituents, regulators, and observers of corporate governance are increasingly focused on the “effectiveness” of board performance: the extent to which its existing governance practices and orientation are consistent with (or exceed) industry standards and recognized principles.

Amidst the ongoing labor market shortages and disruptions from the COVID-19 pandemic, the well-being of physicians and other front-line healthcare providers has become a topic of much attention.

Some commentators have misinterpreted the Bichai decision to mean that a medical staff and its affiliated hospital are entirely independent of each other. In reality, the two entities are practically and legally interdependent. 

- CMS estimates its proposal will result in a decrease of $320 million in Medicare Part A payments to skilled nursing facilities.
- CMS is seeking stakeholder input on the effects of direct-care staffing requirements for long-term care facilities.

The Ninth Circuit Court of Appeals recently reversed the Northern District of California’s landmark decision against UnitedHealth Group Inc.’s behavioral health unit, United Behavioral Health (“UBH”), under which UBH had been ordered to reprocess tens of thousands of behavioral health claims.

On February 22, 2022, the California Department of Public Health (CDPH) announced that vaccinated health care workers with documented recent infection will be allowed to defer booster shot by up to 90 days from infection.

As the COVID-19 pandemic continues, hospitals and other health care providers are facing a separate challenge: “Ivermania”—the wave of lawsuits filed against hospitals by guardians of COVID-19 patients seeking court orders compelling the administration of Ivermectin.

On February 23, 2022, in what is being heralded as a significant victory for health care providers, a federal court in Texas vacated portions of the Biden Administration’s rules governing the arbitration procedures to resolve surprise billing disputes under the federal No Surprises Act (the Act).

On March 3, starting at 10:00 am EST, the FCC’s Connect2Health Task Force (Task Force) will host a virtual event titled: “The FCC Digital Health Symposium: Advancing Broadband Connectivity as a Social Determinant of Health.”

The FCC is requesting public comment on proposed reforms to the Rural Health Care Program to “promote program efficiency and ensure that rural healthcare providers receive appropriate levels of funding.”

Back in 2017, the state of Nevada passed a sweeping bill into law that addressed not only drug pricing transparency, but also reporting obligations applicable to pharmacy benefit managers and non-profit organizations and also imposed certain requirements on manufacturer sales forces.

The “core mission” of the Centers for Medicare and Medicaid Services (CMS) to ensure that the health care providers who care for Medicare and Medicaid patients protect their patients’ health and safety gives the agency broad authority to regulate the conduct and operations of participating providers

The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on January 12, 2022, in the Federal Register.