The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry. On the other hand, getting too specific in the data and focusing on one particular product category can prevent a company from seeing the forest for the trees.
Our colleagues Erik Weibust, Carter DeLorme, and Philip Antablin co-authored an article in AHLA’s Health Law Connections, titled “Securing Key Employees in Health Care M&A Transactions with Restrictive Covenants.” (Read the full version – subscription required.)
Podcast: Post-Dobbs: Access to Reproductive Health Care and Abortion-Inducing Drugs – Diagnosing Health Care
In this episode of the Diagnosing Health Care Podcast: In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.
How can health care providers and pharmacies navigate these new restrictions?
New Jersey Health Care Workers: New Job Protections Following Changes in Control of Their Health Care Entity Employer
Effective November 16, 2022, non-governmental health care entities must offer eligible employees continued employment for at least four months following a change in control without any reduction in their wages and benefits – including paid time off, health care, retirement, and education benefits in accordance with Senate Bill No. 315 (the Law). Change in control includes sales, transfers, assignments, mergers, and reorganizations and is deemed to “occur on the date of execution of the document effectuating the change.”
In this episode of the Diagnosing Health Care Podcast: The past three years have been tumultuous in the health care construction economy, and the patterns in recent construction claims might surprise some. Which types of claims are popping up, in what regions are they appearing, and what types of facilities are involved?
On this episode of our Owner’s Outlook series, hear from special guest Brett Lamb, co-founder and CEO of Construction Discovery Experts.
Interest in and acceptance of telehealth services continues to grow. Recent events, like the COVID-19 pandemic and the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, have put more pressure than ever on federal and state legislators to promote access to telehealth services.
However, the greater use of 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 telehealth opportunities while staying compliant with applicable laws.
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 release our latest compilation of state telehealth laws, regulations, and policies within the mental/behavioral health practice disciplines.
Podcast: Post-Dobbs – Navigating the Fast-Changing and Uncertain Legal Landscape – Diagnosing Health Care
In this episode of the Diagnosing Health Care Podcast: Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, some states have banned abortion in all or most circumstances and many more have enacted new restrictions or enforced old ones.
Rural Emergency Hospitals – CY 2023 OPPS Final Rule Includes Additional Information on New Medicare Provider Type
Announced in the Consolidated Appropriations Act of 2021, Rural Emergency Hospitals (REHs) will be a new type of Medicare provider starting January 1, 2023. REHs are meant to help address the stressed health care system of rural providers by providing an option to closure for distressed critical access hospitals (CAHs) and small rural hospitals.
Existing CAHs and rural hospitals with fewer than 50 beds will be eligible to convert to an REH. CMS is streamlining this process so that this conversion to be an REH can be accomplished through a change of information on an existing Medicare 855A enrollment rather than through a new provider application, which carries potentially significant delays and potential gaps in payment. REHs are designed to provide primarily emergency department, observation, and outpatient services. Because REHs will not provide inpatient care, an area that often creates a significant financial and operational burden on CAHs and small rural hospitals, REHs will allow locally-delivered healthcare to continue to be furnished by existing providers.
It is no secret that the Department of Justice (DOJ) has been largely unsuccessful in the criminal no poach cases it has brought to trial to date. Its most public loss came with the acquittals earlier this year of DaVita, a dialysis company, and certain of its executives in the District of Colorado. DOJ also lost at trial in another high-profile case in the Eastern District of Texas involving a physical therapy staffing company (although it secured a conviction against a company executive for obstruction of justice). But DOJ has pressed on, claiming victories at the motion to dismiss stage. Indeed, following its recent trial losses, Assistant Attorney General Jonathan Kanter, who leads the DOJ’s antitrust division, had this to say:
The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. Instead, I have downloaded all of the data from that database and created my own search engine, but there are still inherent limitations in what the data contain and how they are structured. For one, if you want to submit a premarket notification for an over-the-counter product, it really isn’t easy to find predicates that are specifically cleared for over-the-counter without a lot of manual work.