Health Law Advisor

New York Governor, Kathy Hochul, recently announced proposed cybersecurity rules for New York hospitals, which are due to be imminently published in the State Register on December 6, 2023, subject to approval by the Public Health and Health Planning Council.  The Governor’s press release indicates the proposed regulations, if enacted, will require New York hospitals to meet at least the following requirements: 

• Establish a cybersecurity program and take proven steps to assess internal and external cybersecurity risks;
• Develop a response plan for potential cybersecurity ...

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint ...

On November 7, 2023, the citizens of the state of Ohio voted to codify reproductive rights, including the right to abortion, in the state constitution.

In 2019, Ohio banned nearly all abortions once fetal cardiac activity was detected (typically around six weeks’ gestation) through its “Heartbeat Law.” Challenges to Ohio’s Heartbeat Law  under Roe v. Wade and Planned Parenthood v. Casey prevented it from taking effect until the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization repealed those cases. After Dobbs, Ohio’s “Heartbeat ...

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 ...