Latest 2 Cases This Week: Big Time Vapes, Inc. v. FDA (5th Cir.), General Medicine, P.C. v. Azar (6th Cir.)

The “When” of Chevron: The Missed Opportunity of County of Maui

SAMUEL ESTREICHER, DANIEL FOLSOM

NYU law professor Samuel Estreicher and rising 3L Daniel Folsom comment on the U.S. Supreme Court’s recent decision in County of Maui v. Hawaii Wildlife Fund, in which the Court interpreted a provision of the Clean Water. Estreicher and Folsom argue that the case presented an opportunity to clarify the murky question of when the Chevron doctrine applies, yet the Court avoided answering that question.

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The Unnecessary Protection of Qualified Immunity

JOANNA C. SCHWARTZ, SETH STOUGHTON

UCLA law professor Joanna C. Schwartz and South Carolina law professor Seth W. Stoughton address some of the arguments commonly asserted to support qualified immunity, the doctrine that shields police officers from civil liability for constitutional violations. Schwartz and Stoughton argue that eliminating qualified immunity should not affect police decision-making and that existing Supreme Court doctrine gives police officers plenty of leeway to make mistakes without violating the Constitution. Because qualified immunity applies only to unreasonable actions by police officers, eliminating or substantially restricting it should not a chilling effect on police officers’ ability or willingness to respond to critical incidents.

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Big Time Vapes, Inc. v. FDA

Court: US Court of Appeals for the Fifth Circuit

Docket: 19-60921

Opinion Date: June 25, 2020

Judge: Jerry E. Smith

Areas of Law: Government & Administrative Law, Health Law

In section 901 of the Family Smoking Prevention and Tobacco Control Act (TCA), Congress authorized the Secretary of Health and Human Services to determine which other products should be governed by the TCA's regulatory scheme. Plaintiffs filed suit against the FDA, its Commissioner, and the Secretary, asserting that Congress's delegation to the Secretary was unconstitutional. The Fifth Circuit affirmed the district court's dismissal of the complaint, holding that section 901's delegation to the Secretary does not violate the nondelegation doctrine. The court held that Congress undeniably delineated its general policy in the TCA; Congress plainly limited the authority that it delegated; and the relevant caselaw supports these conclusions.

General Medicine, P.C. v. Azar

Court: US Court of Appeals for the Sixth Circuit

Docket: 19-1365

Opinion Date: June 24, 2020

Judge: Siler

Areas of Law: Government & Administrative Law, Health Law, Public Benefits

General’s clinicians perform services in long-term care facilities. General bills Medicare under 42 U.S.C. 1395. A Centers for Medicare and Medicaid Services (CMS) contractor, AdvanceMed, initiated audits in 2002 after the CMS fraud unit received complaints about General’s billing practices. In 2004 AdvanceMed initiated an audit of General’s physicians without providing any notice to General. AdvanceMed sent records requests to physicians at 12 General facilities, covering 382 claims involving 278 patients in 2002-2004. General was not notified of these requests. AdvanceMed did not request any records from General. AdvanceMed determined that 35 of the 382 claims were allowed as billed; 33 claims were allowed at different levels than billed. The remaining 314 claims were denied: 3 did not meet policy guidelines, 73 had no documentation to support the services, and 238 were medically unnecessary. General learned of this audit when it received a letter in 2007, indicating that General had been overpaid by $16,778.80; the overpayment was extrapolated to a universe of 41,818 claims. The total amount of overpayment demanded was $1,836,646.56. The Appeals Council determined and the Sixth Circuit affirmed that no remedy should be granted because the lack of notice was inconsequential and did not prevent General from ably and thoroughly arguing the principal issues resulting from the audit, the validity of the sampling methodology, and the coverage of the reviewed claims. The addition of more medical records would not have materially impacted its findings.