Health Law Scan

In the complex world of Medicare reimbursement, there are a multitude of payment formulae, mathematical adjustments, and reimbursement calculations that translate congressional policy into operational payments for hospital providers. But sometimes the Centers for Medicare and Medicaid Services (CMS) doesn’t get the math right. Recently, the US District Court for the District of Columbia found that academic medical centers have been subject to one such calculation error that implicates the amount such teaching hospitals receive as payment in support of direct graduate medical education (GME). Milton S. Hershey Med. Ctr. v. Xavier Becerra, Civ. Action No. 19-2680 (May 17, 2021). Based on the court’s reasoning, teaching hospitals operating above their full-time equivalent (FTE) resident cap may have been systematically underpaid as a result of the regulatory payment formula for determining the weighted FTE amount of residents used to calculate the GME payment. Other hospitals have recently followed Hershey Medical into the DC District Court seeking similar decisions.

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.

We invite Health Law Scan readers to join Morgan Lewis for an upcoming webinar series, Privatization of the Vaccine Rollout, which will explore the legal and regulatory issues for businesses that have become increasingly central to rolling out vaccines in the United States and around the globe.

Members of our healthcare team recently published a LawFlash highlighting the American Rescue Plan Act of 2021 (ARPA). ARPA provides $1.9 trillion in relief funding to address the COVID-19 pandemic, support the US economy, and provide relief for impacted Americans, and includes provisions specifically affecting healthcare providers remaining on the frontlines.

Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.

As coronavirus (COVID-19) cases begin to surge in Texas, Governor Greg Abbott issued Executive Order No. GA-27 on June 25 to preserve hospital bed availability for COVID-19 patients.

As we continue to look forward to a new post-pandemic reality, our NOW. NORMAL. NEXT. resource page has a number of recent publications that our friends of Health Law Scan may be interested in.

Morgan Lewis has recently launched a new resource for our clients and friends, Now. Normal. Next., to help navigate the world as we reemerge into a new post-pandemic reality. Health Law Scan will continue to monitor developments around the coronavirus (COVID-19) pandemic, and will begin to highlight our resources to help our healthcare clients navigate the myriad of challenges brought by this new reality.

As we all settle into our new sense of normalcy, Health Law Scan continues to monitor developments surrounding the coronavirus (COVID-19) pandemic. We have lawyers across the firm providing updates on a wide variety of topics to keep our clients apprised of all the developments.

Our telecommunications, media, and technology group prepared a LawFlash discussing two programs that the Federal Communications Commission established on March 31 to help eligible healthcare providers purchase and deploy telehealth technology. The programs provide immediate relief for telehealth and healthcare providers during the coronavirus (COVID-19) pandemic and aim to improve telehealth outcomes over the longer term.