Health Law Advisor

Throughout the course of the pandemic, the Health Resources and Services Administration (HRSA) distributed $178 billion in Provider Relief Funds (PRF) to hospitals and health care providers.  The Public Health Emergency has ended, and HRSA is now turning an eye to how the money was spent, and whether it was spent properly. 

PRF funds were distributed with nearly no-strings-attached; hospitals and providers had to simply agree to a few terms and conditions.  Yet a number of facilities and providers have received one of two types of letters from HRSA: (1) a Final Repayment Notice stating the money must be returned, or (2) a letter stating that HRSA will be conducting an audit.  

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the rulemaking process. Both bills passed the House on party-line votes, and are under consideration by the Senate.

The first bill, H.R. 5, would overhaul multiple phases of the federal rulemaking process. These proposed changes would make the ...

Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent's device, the Relieva Stratus Microflow Spacer ("Stratus"), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant's request to expand the indicated use of the device to include delivery ...

On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient ...

[caption id="attachment_1475" align="alignright" width="113"] Robert E. Wanerman[/caption]

A group of conservative members of Congress have introduced a pair of bills (S. 2724 and H.R. 4768) that would sweep away one of the basic principles of administrative law if they became law. The proposed amendments would make it easier to challenge many determinations involving the Department of Health and Human Services in federal courts by legislatively overruling the deference commonly applied to agency interpretations of the law.

Even before the Administrative Procedure Act was ...

[caption id="attachment_1475" align="alignright" width="113"] Robert E. Wanerman[/caption]

Even after the Secretary of HHS admitted that the current backlog of Medicare Part B appeals would take ten years to adjudicate at current staffing and funding levels, that was not enough for a hospital to obtain any relief from a court. Cumberland County Hospital System, Inc. v. Burwell, No. 15-1393 (4th Cir., Mar. 7, 2016).  In that case, a North Carolina hospital had initially been paid for over 900 claims, but those claims were subsequently determined to be ineligible after a ...