Justia Health Law Opinion Summaries

Plaintiffs sued the Government, seeking to disclaim their legal entitlement to Medicare Part A benefits for hospitalization costs. Plaintiffs wanted to disclaim their legal entitlement to such benefits because their private insurers limited coverage for patients who were entitled to Medicare Part A benefits. Plaintiffs preferred to receive coverage from their private insurers rather than from the Government. The district court granted summary judgment for the Government because there was no statutory authority for those who were over 65 or older and receiving Social Security benefits to disclaim their legal entitlement to Medicare Part A benefits. The court understood plaintiffs' frustration with their insurance coverage. But based on the law, the court affirmed the judgment of the district court.

Appellants, manufacturers, distributors, and users of ear candles, along with organizations that advocate the use of holistic health remedies like ear candles, challenged warning letters the FDA issued to several manufacturers, advising that the agency considered their candles to be adulterated and misbranded medical devices. The district court dismissed appellants' complaint on the ground, among others, that the warning letters did not constitute final agency action. The court affirmed the district court's order to dismiss for failure to state a claim because the warning letters, even as supplemented by the FDA's website and appellants' conversations with FDA officials, did not constitute final agency action and therefore, appellants' complaint was not cognizable under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq.

An association of doctor-owned equipment providers challenged regulations issued by the Secretary that effectively prevented its members from obtaining Medicare reimbursement for their services. The district court dismissed the complaint for lack of subject matter jurisdiction. The court concluded that under the particular circumstances of this case, the Shalala v. Illinois Council on Long Term Care, Inc. exception applied and the association could invoke the district court's federal question jurisdiction without first seeking administrative review under the Medicare Act, 42 U.S.C. 405(h).

This case arose when the Board found petitioner had acted unlawfully by unilaterally reducing the hours of its full-time respiratory department employees. The Board ordered petitioner to rescind the hours reduction, bargain with the labor union representing the affected employees, and make whole any employee for any loss of earnings and other benefits suffered (2004 Order). An ALJ subsequently determined that petitioner owed 13 current and former employees roughly $105,000 in backpay to compensate them for the unlawful hour reduction and the Board adopted the ALJ's findings without elaboration, ordering petitioner to pay (2011 Order). Petitioner appealed the 2011 Order and the Board cross-applied for enforcement. The court granted in part the Board's cross-application for enforcement with respect to all issues except the matter relating to interim earnings. The Board did not err in applying a backpay remedy to those employees hired into the bargaining unit after petitioner unlawfully reduced the employees' hours; and the Board correctly held the Union's failure to communicate with petitioner did not toll the employer's liability, because petitioner had not rescinded the unlawful unilateral reduction in hours when it sought to negotiate with the Union. However, the Board did not adequately explain its failure to consider interim earnings when calculating the backpay award. Therefore, the court vacated the Board's backpay computation and remanded so the Board could amplify its position on interim earnings.

Appellant, which sought review under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq., claimed that the Secretary's delegee failed to disapprove appellant's reimbursement request within 60 working days, as required by the Medicare Act, 42 U.S.C. 1395rr(b)(7), because the delegee did not notify appellant of its asserted disapproval within the 60-day time period. Appellant appealed the district court's grant of summary judgment to the Secretary. The court concluded that the notification of appellant within 60 days was not necessary for the disapproval to be effective and therefore affirmed the judgment of the district court.

This suit involved a challenge to the "minimum essential coverage provision," which required all "applicable individual[s]" to purchase and maintain "minimum essential coverage" for each month beginning in January 2014 under the Patient Protection and Affordable Care Act (Act), Pub. L. No. 111-148, 124 Stat. 119. Appellants, four United States citizens and federal taxpayers, sought declaratory and injunctive relief to prevent various U.S. Government officials and agencies from enforcing the minimum essential coverage provisions. They argued that the mandate exceeded Congress's authority under the Commerce Clause and substantially burdened appellants' religious exercise, in violation of the Religious Freedom Restoration Act, 42 U.S.C. 2000bb et seq. The district court rejected appellants' challenge to the Act and they appealed. Despite questions raised as to the court's subject matter jurisdiction, the court concluded that it had jurisdiction and affirmed the district court's conclusion that the Act was constitutional.

Petitioner sought review of a decision of the Federal Mine Safety and Health Review Commission, an agency within the United States Department of Labor. The issue on appeal was whether a Mine Safety and Health Administration (MSHA) inspector was authorized to designate the violation of a safeguard notice issued pursuant to section 314(b) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 801 et seq., as "significant and substantial" under section 104(d)(1) of the Mine Act, which limited the "significant and substantial" designation to a violation of a "mandatory health or safety standard." The court agreed with the Commission majority that the violation of a safeguard notice issued pursuant to section 314(b) amounted to a violation of section 314(b) and was therefore a violation of a mandatory safety standard which could be designated "significant and substantial." Accordingly, the court denied the petition.

In a 2008 administrative appeal, the Secretary of Health and Human Services ruled that a Medicare beneficiary enrolled in Medicare Part C still qualified as a person "entitled to benefits" under Medicare Part A. As a result, Beverly Hospital received a smaller reimbursement from the Secretary for services it provided to low-income Medicare beneficiaries during fiscal years 1999-2002. The district court granted summary judgment for Beverly Hospital on the ground that the Secretary's interpretation violated the plain language of the Medicare statute. The court held that the statute did not unambiguously foreclose the Secretary's intepretation. The court, nonetheless, affirmed the district court on the alternative ground that the Secretary must be held to the interpretation that guided her approach to reimbursement calculations during fiscal years 1999-2002, an interpretation that differed from the view she now advanced. Under her previous approach, the hospital would have prevailed on its claim for a larger reimbursement.

Defendant pled guilty to one count of identity theft as part of a plea agreement where defendant had treated hundreds of patients while falsely representing that he was a licensed physician. In determining defendant's sentence, the district court increased his sentence under U.S.S.G. 3A1.1(b)(1) because some of his patients were children with serious mental health conditions. On appeal, defendant disputed the increase in his offense level, contending that section 3A1.1(b)(1)'s 2-level adjustment for vulnerable victims applied only to victims of defendant's offense of conviction, who in this case would include only those victims who suffered financial loss. The court disagreed and held that the adjustment applied not only to victims of the offense of conviction, but also to victims of defendant's relevant conduct. Accordingly, the court affirmed the judgment of the district court.

Petitioners petitioned for review of a regulation promulgated by the EPA setting performance standards for new and existing hospital/medical/infection waste incinerators ("HMIWI"). Petitioners argued that the data set EPA used to establish these standards was flawed, that the agency's pollutant-by-pollutant approach to setting target emissions levels was impermissible, and that the agency acted arbitrarily when it removed a provision exempting HMIWI from complying with the standards during periods of startup, shutdown, and malfunction. The court held that the EPA's decision to use emissions data from the HMIWI units remaining in operation after the implementation of the 1997 standards, once it determined that the data set upon which it had relied in 1997 was flawed, was reasonable. The court held, however, that it did not have jurisdiction to review the challenges to the EPA's long-standing practice of setting emissions floors based on emissions levels achieved by the best performing unit or units for each individual pollutant, and to the agency's removal of an exemption from compliance with emissions limitations during periods of startup, shutdown, and malfunction. Accordingly, the petitioned was dismissed in part and denied in part.