Blogs
Clock 5 minute read

As health care entities around the country face staffing shortages, hospitals have started to turn to apps to fill nursing shifts. New apps allow hospitals to engage nurses as independent contractors to fill open shifts, allowing nurses to bid on shifts and select hours that match their schedule. Apps allow nurses to work as independent contractors and engage directly with the hospital as opposed to employees of the hospital or a nursing staffing agency that then engages on their behalf to staff the hospital. The Wall Street Journal recently reported on these apps, crediting their rise to nurses retiring or leaving the field after burn out from the COVID-19 pandemic, from which hospitals are still struggling to recover. But, these apps have existed for several years, and employment issues such as correct calculation of wages and tracking work time are something Epstein Becker Green has previously spotted.

Blogs
Clock 2 minute read

In this episode of the Diagnosing Health Care Podcast The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.

What key compliance issues must industry stakeholders consider as these provisions are put into effect?

On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of ...

Blogs
Clock 4 minute read

The Centers for Medicare & Medicaid Services (“CMS”) is using its annual rulemaking process to update the CMS payment system rules for fiscal year (“FY”) 2024 as a mechanism to advance health equity systematically across various CMS payment programs. Specifically, CMS is incorporating proposals to advance health equity in its proposed payment rules for inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient psychiatric facilities, and hospices, and in the final rate announcement for the Medicare Part C and Part D programs for FY 2024. Significantly, in several instances, CMS is requesting comments, which opens the door for providers to share their input about relevant considerations. This CMS initiative is consistent with key components that were detailed in CMS’s “Framework for Health Equity,” the agency’s 10-year plan to “remedy systemic barriers to equity so that every one [CMS] serve[s] has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.”[1] This post outlines the changes being proposed by CMS, as well as highlights opportunities where providers should consider preparing and submitting comments.

Blogs
Clock 7 minute read

In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests.  I looked at response times and then started to dive into the topics that requesters were asking about.  This is the third and final post on this data set, and it builds on the last post by taking the topics identified there to explore success rates by topic.  From there, I look at who is asking about those topics and how successful those individual companies are in their requests.

Blogs
Clock 9 minute read

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.

Blogs
Clock 2 minute read

In this episode of the Diagnosing Health Care Podcast A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

Blogs
Clock 2 minute read

In this episode of the Diagnosing Health Care Podcast Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon?

Blogs
Clock 9 minute read

On March 22, 2023, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) updated its Frequently Asked Questions (“FAQs”), drafting 13  FAQs aimed at easing the transition from COVID-era flexibilities to the end of the Public Health Emergency (“PHE”) on May 11, 2023. These FAQs arrive on the tail of OIG’s March 10, 2023 COVID-19 Public Health Emergency policy statement, which announced that the expiration of the PHE in May also marks the end of flexibilities extended during the crisis.  The updated FAQs offer a glimpse into how OIG investigations and enforcement might play out after the end of the PHE.  These FAQs address subjects including “General Questions Regarding Certain Fraud and Abuse Authorities,” the “Application of Certain Fraud and Abuse Authorities to Certain Types of Arrangements,” and “Compliance Considerations.”  

The vast majority of the principles articulated in the updated FAQs will undoubtedly be familiar to many.  Generally speaking, the updated FAQs restate or clarify longstanding OIG policy.  The updated FAQs are more than reiteration, however; they offer condensed policy and explanation in a single location, and demonstrate that for the most part, investigations and enforcement may return to the pre-PHE status quo. 

Blogs
Clock 2 minute read

On April 11, 2023, U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced its plan for termination of the existing notifications of enforcement discretion related to the expiration of the COVID-19 public health emergency (PHE) on May 11, 2023. 

Blogs
Clock 10 minute read

The Department of Health and Human Services Office of Inspector General (OIG) recently published a new frequently asked question (FAQ) and advisory opinion addressing how to analyze arrangements that may involve providing cash, cash equivalents, and/or gift cards to Medicare and/or Medicaid beneficiaries under the beneficiary inducements prohibition provision in the Civil Monetary Penalty Law (Beneficiary Inducements CMP) and Anti-Kickback Statute (AKS).

Search This Blog

Blog Editors

Recent Updates

Related Services

Topics

Archives

Jump to Page

Subscribe

Sign up to receive an email notification when new Health Law Advisor posts are published:

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.