Health Law Advisor

On July 1, 2024 the Center for Medicare and Medicaid Innovation (“CMMI”) will be inaugurating a new value-based payment model designed specifically to address the devastating impacts that a diagnosis of dementia^[1] or Alzheimer’s Disease[2] can have on a patient, their family, friends, and other caregivers who make up the patient’s circle of support. The Centers for Medicare and Medicaid Services (“CMS”) designed the Guiding an Improved Dementia Experience (“GUIDE”) model (the “Model”) for health care providers enrolled in Medicare Part B and that treat ...

In this episode of the Diagnosing Health Care Podcast:  From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed significant changes that, if adopted, will have profound effects on merger review and enforcement for the foreseeable future.

What might these changes mean for hospitals, health systems, and other stakeholders in the health care industry?

On this episode, Epstein Becker Green attorneys Trish ...

Interest in and acceptance of telehealth services continues to grow. In 2023, a key focus by the states has been addressing questions about how to modify existing regulatory infrastructures sustaining the provision of telehealth services to support the continued use of these services in a post-public health emergency world.

However, modifications to telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on ...

Our latest focus is trying to bring data to bear on common questions we get asked by clients.  Last month the topic was: how well does my device need to perform to get premarket clearance from FDA?  This month it is: how big does my sample size need to be for any necessary clinical trial for premarket clearance? 

To date, our typical answer has been, it depends.[1]  We then explain that it’s not really a regulatory question, but a question for a statistician that is driven by the design of the clinical trial.  And the design of the clinical trial is driven by the question the clinical trial is trying ...

Last month, the U.S. Supreme Court declined to review a case challenging the sufficiency of due process protections in the Health Care Quality Improvement Act (HCQIA) and National Practitioner Data Bank (NPDB), effectively confirming that the current safeguards are constitutionally sufficient.

In Doe v. Rodgers, a surgeon brought an action against the Secretary of the U.S. Department of Health and Human Services (HHS), the NPDB, and several individual officials who administer the NPDB, alleging that the NPDB wrongfully accepted, kept, and distributed a “false and ...

In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.

In light of these recent actions, what challenges are dietary supplement manufacturers now facing?

On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) quietly added “Outreach Site/ Street” as an allowable place of service (POS) code for Medicare and Medicaid providers to use in claims submission for “street medicine” services provided. The “Outreach Site/ Street” POS code allows physicians to seek Medicare reimbursement of such medically necessary professional services when they are delivered in a “non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide ...

In an indictment announced on October 26, 2023 in Miami, the U.S. Department of Justice, Criminal Division’s Fraud Section, working with the FBI and HHS-OIG, brought what may be only the second federal criminal charges directly related to the Medicare Advantage (Medicare Part C) risk adjustment payment methodology.  DOJ enforcement in the Medicare Advantage risk adjustment space overwhelmingly has proceeded civilly under the False Claims Act. Although the allegations suggest conduct far more troubling than prior civil cases under risk adjustment, these criminal charges ...

On October 31, 2023, FDA hosted a webinar to address some of the frequently asked questions the agency has received since the September 29, 2023 release of its proposed rule on laboratory developed tests (“LDTs”). The materials from the webinar are available on FDA’s CDRH Learn webpage. Importantly, FDA announced during the webinar that the agency does not currently plan to extend the comment period for the proposed rule beyond the standard 60-day timeframe, and therefore, comments are still due on Monday December 4, 2023. In both the preamble to the proposed rule and stated ...

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also available.

This EO is a significant milestone as companies and other organizations globally grapple with the trustworthy use and creation of AI.  Previous Biden-Harris Administration action on AI have been guidance of principles (e.g., the AI Bill of Rights) or have been targeted guidance on a particular aspect of AI such as the Executive Order Addressing Racial ...