Health Law Advisor

Background

On December 10, 2024, the Supreme Court of Ohio issued its decision in Stull v. Summa, a medical negligence case in which the defendants argued that Ohio’s statutory peer-review privilege protected from discovery the file the hospital maintained on a resident physician, which included, among other things, quality reviews and assessments of the resident’s clinical competency and professional conduct. The Supreme Court of Ohio decided one issue: Does the peer-review privilege in R.C. 2305.252 apply to a health care entity’s files about resident physicians?

This case arose from the medical treatment of head injuries that the patient sustained during a car crash. The patient and his guardians filed a medical negligence lawsuit against the hospital and its employed health care professionals, including a resident physician who participated in the patient’s care. The plaintiffs alleged that the resident improperly intubated the patient, causing the patient to sustain a brain injury.

You may be familiar with the data that FDA publicly shares on devices designated as having breakthrough status, and devices ultimately approved after receiving that status. As of September 30, 2024, 1041 devices had received breakthrough designations, and 128 of those devices had received ultimate clearance or approval. Inquiring minds want to know, though: what about the difference, the 913 devices granted breakthrough designation but at least not yet approved or cleared? 

I wanted to learn as much as I could about those devices, so I submitted a FOIA request.  The numbers are not going to match up with the public data, in part because my FOIA request only extended through June 1, 2024.  But the data FDA shared in response to my FOIA are quite revealing, both about where industry has placed its development priorities in terms of potential breakthrough devices and where FDA seems inclined to grant breakthrough designation. We also learned how quickly FDA responds to requests for breakthrough designation.

Results

Let’s start with how quickly FDA responds. As a preliminary note, these data only reflect where the designation has been granted, not whether designation has been rejected. I have no data on rejections. But at least for those where FDA responds favorably, here’s what the responses look like in terms of timing by therapeutic area.

In our ongoing series of blog posts, we have examined key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions designed to protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous blog posts, we considered the importance of negotiating initial terms and renewal terms, operating expense provisions, assignment and subletting terms, maintenance and repair obligations, holdover provisions and surrender terms, tenant improvement allowances, exclusivity, expansion and relocation provisions, and default provisions. This final blog post in our series focuses on negotiating the letter of intent.  

While a letter of intent (“LOI”) is usually non-binding, it is an extremely important part of the lease process and a valuable tool to make expectations clear and prevent time consuming and costly back and forth during lease negotiations. The topics covered in our earlier blog posts in this series should be addressed in the LOI, which should serve as a road map for the parties and counsel in drafting and negotiating the lease. By agreeing on these basic terms up front, the parties will significantly reduce the amount of back and forth needed to arrive at a lease both parties find acceptable.

In our ongoing series of blog posts, we have examined key negotiating points for tenants in triple net health care leases.

We have also offered suggestions for certain lease provisions designed to protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous blog posts, we considered the importance of negotiating initial ...

New from the Diagnosing Health Care Podcast: The recent 2024 elections resulted in a new Trump administration and a Republican-controlled House and Senate.

From policymakers to stakeholders across the industry, everyone is wondering what health policy will look like in 2025 and beyond.

On this episode, Epstein Becker Green attorneys Ted Kennedy Jr., Leslie Norwalk, Philo Hall, and Alexis Boaz discuss the results of the 2024 elections and their impact on the health policy space. What will a second Trump administration look like? How might the election results affect the health care policies addressed during Congress’s 2024 lame-duck session?

As the dietary supplement industry continues to draw attention from Congress, state attorneys general, and class action lawyers, now comes another state law prohibiting the sale of over-the-counter (“OTC”) dietary supplements that target weight loss and muscle building to minors – this time, in New Jersey.

On October 28, 2024, by a majority vote of 56 to 17, with four abstentions, the New Jersey General Assembly passed Assembly Bill No. 1848, which, if it goes into effect, will prohibit the sale or delivery of OTC diet pills, weight loss, and muscle building supplements to minors, unless the minor is accompanied by a parent or guardian. Bill No 1848 is an exemplar of efforts intended to combat the misuse and abuse of these products and the potential causal relationship between these dietary supplements and eating disorders. Violators, including employees of retail establishments, may face a civil penalty of not more than $750.

On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Third Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Third Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2025. The Third Temporary Extension is scheduled for publication in the Federal Register on November 19, 2024.

This means the DEA will continue to allow DEA registered practitioners (“Practitioners”) to prescribe controlled substances via telemedicine without having previously conducted an in-person patient examination. Likewise, and of particular interest to telemedicine providers that practice in multiple states, Practitioners may continue prescribing via telemedicine to patients physically located in any state in which the Practitioners are licensed to practice medicine, without needing to have a separate DEA registration in each such state, subject to compliance with state prescribing requirements.

The Centers for Medicare and Medicaid Services (CMS) is issuing, what will amount to be, very significant Risk Adjustment Data Validation (RADV) Audit notices for PY2018 to Medicare Advantage Organizations (MAOs).

These notices follow the issuance of CMS’s final rule (88 Fed. Reg. 6643 (Feb. 1, 2023), amending 42 C.F.R. 422.310(e). Pursuant to the rule, CMS has the authority to extrapolate audit findings for PY2018 and beyond. CMS has noted that the extrapolation methodology it adopts for RADV audits will be focused on MAO contracts that, through statistical modeling ...

As the dust from the public health emergency (PHE) continues to settle and the PHE-era flexibilities expire, telehealth providers are bracing themselves for the changes soon to come.

These providers will inevitably face certain legal and regulatory complexities as federal and state lawmakers and regulators consider adopting further temporary or permanent policy changes impacting telehealth. Federal-level changes—particularly the Drug Enforcement Administration’s (DEA’s) remote prescribing rulemaking—may further compound these complexities and trigger a wave of changes in laws, regulations, and policies at the state and board levels.

Telehealth providers should continue to monitor these developments, capitalize on current and upcoming telehealth opportunities, and make investments in compliance infrastructures to operate in accordance with applicable federal and state laws, regulations, and policies.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. 

We are pleased to once again release our latest update to our Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.

In response to several high-profile cybersecurity incidents affecting hospitals and other health care providers, including the Change Healthcare breach, new federal legislation was recently introduced by Senators Ron Wyden (D-OR) and Mark Warner (R-VA). The health care industry has received intense criticism for perceived weaknesses in cybersecurity protections.   As stated in a summary of HISAA prepared by the Senate Finance Committee: 

According to the FBI, the health care sector is now the #1 target of ransomware. These hacks are entirely preventable and are the direct result of lax cybersecurity practices by health care providers and their business partners. Cybersecurity failures have delayed and disrupted patient care, and have harmed patient health and privacy, as well as national security. Despite these high stakes, health care has some of the weakest cybersecurity rules of any federally regulated industry.

The new legislation, the Health Infrastructure Security and Accountability Act (HISAA), would create significant new security requirements applicable to HIPAA Covered Entities and Business Associates designed to address cybersecurity risks, require ongoing risk assessments and audits related cybersecurity practices, establish new penalties for noncompliance with these requirements and remove HIPAA statutory caps on such penalties, and create funding incentives and Medicare payment reduction disincentives for entities subject to these requirements.