Health Law Advisor

In this episode of the Diagnosing Health Care Podcast: Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities.

In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to advance health equity?

On this episode, Epstein Becker Green attorneys Jackie Selby, Kevin Malone, and Marjorie Scher discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable.

In this episode of the Diagnosing Health Care Podcast: What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders?

At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies, yet no two states are exactly alike in their approach to defining and regulating telehealth.

On this episode ...

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than others. This month, continuing the analysis I started in my October post regarding device-related citizens petitions, I used topic modeling on the citizens petitions to see which topics are most frequent, and whether there are significant differences in the amount of time it takes for FDA to make a decision based on the topic.

Discerning the Topics

As you probably ...

An increasing number of states are requiring advance notice of health care transactions.  These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1, 2023, New York[1] enacted legislation that requires health care entities involved in material transaction(s) to provide written notice to the New York Department of Health at least 30 days prior to the closing of the transaction. In enacting the legislation, New York joined Connecticut[2], Massachusetts[3], Nevada[4], Oregon[5], Rhode Island[6], and ...

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 ...