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Legal Insights and Perspectives for the Healthcare Industry
Substantial change is imminent for key labor law issues commonly affecting healthcare entities. Healthcare employers utilize handbooks and rules, implement property access controls, and engage in human resources investigations, for instance. All these areas, and more, are poised for change with the new Biden-Harris administration National Labor Relations Board (NLRB) general counsel memorandum, highlighting a swath of legal issues where the general counsel will litigate test cases to change the law.

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.

Members of our labor, employment, and benefits team recently published a LawFlash discussing the Occupational Safety and Health Administration’s (OSHA’s) updated nonbinding COVID-19 guidance applicable to all industries not otherwise covered by the OSHA Emergency Temporary Standard.
In the most recent edition of our Global Healthcare Transactions Series, we focus on the Asia-Pacific region, which saw a wave of healthcare activity in 2020 including record high deals and a new peak for disclosed value. These gains can be attributed to macroeconomic trends such as aging populations and increasingly affordable healthcare, and favorable government policies encouraging local manufacturing and development of healthcare products.

A notable headline from the August 12 MLN Connects Newsletter for healthcare providers states “CMS Resumes Targeted Probe & Educate Program.” Designed to help providers reduce claim denials and appeals, CMS suspended prepayment reviews under the Targeted Probe and Educate (TPE) program in response to the COVID-19 public health emergency (PHE) in March 2020. But unlike post-payment audits which have been active since CMS authorized its contractors to begin new audits in August 2020, TPE prepay reviews remained on hold.

Members of our labor and employment and healthcare teams recently published a LawFlash covering the US Department of Justice’s (DOJ’s) definitive guidance which specifically concluded that “federal law does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to emergency use authorizations from the U.S. Food and Drug Administration.”

Our labor and employment team recently published a LawFlash analyzing the US Departments of Treasury, Labor, and Health and Human Services and Office of Personnel Management’s Requirements Related to Surprise Billing; Part 1.

We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring Katie McDermott and Howard Young analyzing this protracted suit filed under the qui tam provisions of the False Claims Act (FCA) against the owners of two specialty clinical laboratories and a contracted sales and marketing company.

Members of our emerging business and technology team recently hosted a webinar on seed financing structures for digital health companies. The program, led by partner Benjamin David Novak and associate Jessica Lee, discussed the market trends in digital health company financings as well as the various deal structures frequently used in seed financings.
The Centers for Medicare and Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning telehealth, remote physiologic monitoring (RPM), and new remote therapeutic monitoring codes. Coming on the heels of the significant telehealth waivers put in place during the COVID-19 public health emergency (PHE), CMS proposes to continue the steady expansion of virtual care options with this rule.