Justia U.S. 11th Circuit Court of Appeals Opinion Summaries

The Secretary determined that Bayou Shores was not in substantial compliance with the Medicare program participation requirements, and that conditions in its facility constituted an immediate jeopardy to residents’ health and safety. The bankruptcy court assumed authority over Medicare and Medicaid provider agreements as part of the debtor’s estate, enjoined the Secretary from terminating the provider agreements, determined for itself that Bayou Shores was qualified to participate in the provider agreements, required the Secretary to maintain the stream of monetary benefit under the agreements, reorganized the debtor’s estate, and finally issued its Confirmation Order. The district court upheld the Secretary’s jurisdictional challenge and reversed the Confirmation Order with respect to the assumption of the debtor’s Medicare and Medicaid provider agreements. The court concluded that the statutory revision in this case does not demonstrate Congress's clear intention to vest the bankruptcy courts with jurisdiction over Medicare claims. Therefore, the court agreed with the district court that the bankruptcy court erred as a matter of law when it exercised subject matter jurisdiction over the provider agreements in this case. The bankruptcy court was without 28 U.S.C. 1334 jurisdiction under the 42 U.S.C. 405(h) bar to issue orders enjoining the termination of the provider agreements and to further order the assumption of the provider agreements. Accordingly, the court affirmed the judgment. View "Florida Agency for Health Care Admin. v. Bayou Shores" on Justia Law

Allstate filed suit against multiple defendants, alleging claims of fraud, negligent misrepresentation, and unjust enrichment. Defendants are medical clinics that appointed Dr. Sara Vizcay as their medical director. Allstate’s central allegation is that Dr. Vizcay failed to systematically review billings as required by Florida’s Health Care Clinic Act, Fla. Stat. 400.990 et seq., which caused the clinics to submit unlawful or fraudulent insurance claims to Allstate. A jury found the clinics liable and awarded damages to Allstate. The clinics challenge the jury’s verdict, and the district court’s denial of their dispositive motions, on numerous grounds. The court held that, under Florida law, there is judicial remedy for a licensed clinic’s violation of the Clinic Act; a licensed clinic can be held responsible for its medical director’s failure to comply with the duties enumerated in the Clinic Act; the evidence is sufficient to support the jury’s finding that Dr. Vizcay failed to substantially comply with those duties; Allstate's fraud claims are not barred by Florida's statute of limitations; and the district court did not err in denying defendants' motions to bifurcate the trial. Accordingly, the court affirmed the judgment. View "Allstate Ins. Co. v. Vizcay" on Justia Law

VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law

In these consolidated appeals, plaintiff challenged the regulations implementing the contraceptive mandate of the Affordable Care Act, 42 U.S.C. 300gg-13(a), arguing that the regulations’ accommodation for nonprofit organizations with a religious objection to providing contraceptive coverage violates the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb, et seq. The court concluded that the regulations do not substantially burden plaintiffs' religious exercise and, alternatively, because (1) the government has compelling interests to justify the accommodation, and (2) the accommodation is the least restrictive means of furthering those interests. The court rejected EWTN’s challenges under the Establishment and Free Exercise Clauses because the accommodation is a neutral, generally applicable law that does not discriminate based on religious denomination. The court also rejected EWTN’s challenge under the Free Speech Clause because any speech restrictions that may flow from the accommodation are justified by a compelling governmental interest and are thus constitutional. View "Eternal Word Television Network v. Secretary" on Justia Law

LabMD appealed the district court's dismissal of its challenges to the FTC's ability to regulate and conduct enforcement proceedings in the area of healthcare data privacy, arguing that the FTC's enforcement action violates the Administrative Procedure Act (APA), 5 U.S.C. 704; is ultra vires; and is unconstitutional. The court held that the FTC's order denying LabMD's motion to dismiss was not a "final agency action," as required of claims made under the APA and, therefore, those claims were properly dismissed. The court also concluded that LabMD's other claims are intertwined with its APA claim for relief and may only be heard at the end of the administrative hearing. Therefore, the court affirmed the district court's order dismissing the case for lack of subject-matter jurisdiction. View "LabMD, Inc. v. Federal Trade Commission" on Justia Law

Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-3733, alleging that healthcare clinics provided, and the Humana defendants either knew of or promoted, a variety of free services for patients and health plan members. Relator alleged that the clinics offered such services without regard for medical purpose or financial need and that the value of the services is more than nominal. The court affirmed the district court's dismissal of the amended complaint with prejudice where, under the prior or amended version of section 3730 of the FCA, relator cannot overcome the public disclosure bar. View "Osheroff v. Humana Inc." on Justia Law

Kawa filed suit challenging the Treasury's decision to postpone the enforcement of the employer mandate provisions of the Patient Protection and Affordable Care Act (ACA), 26 U.S.C. 4980H, and sought a declaratory judgment and injunction setting aside the Treasury's transition relief. Kawa had expended time and money to determine how to comply with the employer mandate between early 2013 and the end of June 2013. After Kawa incurred these expenses, the Treasury announced it would not enforce the mandate for a transition period of one year - until the end of 2014. The Treasury then extended the transition relief for certain employers, including Kawa, for a second year. The court affirmed the district court's dismissal of the complaint because Kawa lacked Article III standing where Kawa failed to allege an injury in fact, a causal connection, and a likelihood of success. View "Kawa Orthodontics, LLP v. Secretary, U.S. Dept. of the Treasury, et al." on Justia Law

Plaintiff, a Florida resident, wanted to file suit against his doctor for medical negligence. Before filing suit, plaintiff had to comply with Florida's presuit requirements. At issue was whether the presuit authorizations in Fla. Stat. 766.1065, requiring that plaintiff execute a written authorization form for release from protected health information, is preempted by the Health Insurance Portability and Accountability Act (HIPAA), 45 C.F.R. 164.508, 164.5. The court concluded that the written authorization form required in section 766.1065 fully complied with HIPAA and, therefore, there was no federal preemption of section 766.1065. The court reversed the judgment of the district court holding otherwise. View "Murphy v. Dulay, et al." on Justia Law

Astellas holds patents on a cardiac test and sells its unpatented pharmaceutical product, Adenoscan, for using during that test. The Medical Center, which conducts cardiac tests, filed suit under Section 1 of the Sherman Act, 15 U.S.C. 1, alleging that Astellas is able to overcharge the Medical Center for the Adenoscan product by unlawfully tying the patented right to perform the patented cardiac test to the purchase of the unpatented Adenoscan. The court concluded that the district court did not abuse its discretion in refusing the Medical Center's request to certify a class seeking damages against Astellas for unlawful tying because the direct purchaser rule precludes the Medical Center's own treble damages claim. The district court also did not abuse its discretion in refusing to certify the class for purposes of seeking injunctive and declaratory relief. Accordingly, the court affirmed the judgment of the district court.View "Lakeland Regional Medical Center v. Astellas US, LLC, et al." on Justia Law

The Hospital filed suit against various federal agencies and officials, seeking a declaratory judgment that 18 U.S.C. 4006(b)(1), where Congress has elected to impose the Medicare rate as full compensation for medical services rendered to federal detainees, is unconstitutional as applied. The court concluded that the Hospital voluntarily opted into the Medicare program and is, as a result, required to provide emergency services to federal detainees. Consequently, the Hospital was foreclosed from challenging this compensation scheme as an unconstitutional taking under the Fifth Amendment. The court noted that the Hospital's most effective remedy may lie with Congress rather than the courts. Accordingly, the court affirmed the district court's dismissal of the action.View "Baker County Medical Services v. U.S. Attorney General, et al." on Justia Law