Recent Blog Posts
- Congress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts? 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... More
- Parallel Review – Forcing Manufacturers to Go All In On October 24, 2016 the Food and Drug Administration (“FDA”) in conjunction with the Centers for Medicare & Medicaid Services (“CMS”) announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally. Sounds good. So, why have so few manufacturers taken advantage of the program to date?
Despite its admirable goals, the current... More
- “Good Faith” Off-Label Promotions Saved Ex-Acclarent Execs from Felony Misbranding Indictments 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... More
- Disruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos 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... More
- Has Chevron Deference Run Out of Gas? Robert E. Wanerman
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 enacted in 1946,... More
- Pursuing Medicare Appeals Is Not for the Impatient Robert E. Wanerman
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... More
- The Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.
First, although Centers for Medicare & Medicaid Services (CMS) was required... More