Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Wright v. Secretary of Health and Human Services
B.W., a two-year-old in good health, experienced immune thrombocytopenic purpura after receiving his measles, mumps, and rubella vaccine. Later blood tests showed his condition had resolved. More than six months after he was first diagnosed, B.W. presented with bruising, a possible symptom of immune thrombocytopenic purpura, but blood tests showed the condition had not recurred. In a suit under the National Childhood Vaccine Injury Act of 1986, the Claims Court ruled in favor of B.W., holding that those blood tests, occurring more than six months after his initial diagnosis, were “residual effects” of B.W.’s vaccine injury that satisfied the severity requirement of 42 U.S.C. 300aa-11(c)(1)(D).The Federal Circuit reversed. A residual effect must be a change within the patient that is caused by the vaccine injury. B.W.’s later bruising was not caused by his vaccine injury, and his tests did not reveal, constitute, or cause any somatic change. Tests revealed B.W. had no lingering symptoms or recurrence of thrombocytopenic purpura. There was no argument that the testing itself was detrimental to B.W.’s health such that it might qualify under section 300aa-11(c)(1)(D)(i) as a “residual effect” or a “complication” of thrombocytopenic purpura. View "Wright v. Secretary of Health and Human Services" on Justia Law
D&G Holdings, LLC v. Becerra
D&G, a Medicare service provider for nursing homes and homebound individuals, filed suit against the H.H.S. Secretary in federal court seeking repayment of recouped funds, which then amounted to $4,136,258.19 in principal and $593,294.54 in accrued interest. The district court dismissed D&G's case for lack of subject matter jurisdiction, holding that there was no federal court jurisdiction pursuant to 42 U.S.C. 405(g), as applied to Medicare appeals by 42 U.S.C. 1395ff(b)(1)(A).The Fifth Circuit held that "effectuations" of final agency decisions when sought to liquidate the amount of repayment owed, are reviewable under 42 U.S.C. 405(g) as continuous aspects of the initial, properly exhausted, administrative decision. The court concluded that the district court had jurisdiction under section 405(g) to resolve this dispute because "effectuations" are inextricably intertwined with the initial exhausted agency action. Therefore, the district court committed reversible error when it granted the Secretary' motion to dismiss. Furthermore, the Secretary's attempted reopening of the "effectuation" was untimely and the purported reopening was void ab initio. The court reversed and remanded for further proceedings. View "D&G Holdings, LLC v. Becerra" on Justia Law
In the Matter of the Necessity for the Hospitalization of: Mark V.
A man with severe mental illness stabbed his parents during a psychotic episode and was subsequently committed to a psychiatric hospital. He appealed that commitment order. Before the commitment hearing, he stopped taking prescribed medications, leading hospital staff to petition for permission to administer medication involuntarily. The court granted the medication petition as well as a revised petition requesting a higher dose. He also appealed the order authorizing involuntary administration of medication. Finding the superior court did not err in its finding there was no less restrictive alternative to confinement, or that the court did not err petitioner lacked capacity to give or withhold consent to psychotropic medication, the Alaska Supreme Court affirmed both orders. View "In the Matter of the Necessity for the Hospitalization of: Mark V." on Justia Law
Yates v. Pinellas Hematology & Oncology, P.A.
In this qui tam action, after the jury found that Pinellas violated the False Claims Act and that the United States sustained damages, the district court trebled the damages and imposed statutory minimum penalties of $1,177,000 ($5,500 for each of the 214 violations).The Eleventh Circuit affirmed in part and reversed in part. The court upheld the district court's admission of Exhibit 24 where Pinellas failed to argue that the admission of the evidence constituted plain error. The court concluded that there was sufficient evidence for the jury to have found that, had Medicare known of Pinellas's misrepresentations, it would not have paid the refiled reimbursement claims. Furthermore, viewed in the light most favorable to the verdict, the evidence on scienter is not overwhelmingly in favor of Pinellas. Therefore, the jury's decision stands. The court also upheld the jury's findings on damages where the court concluded that the proper measure of damages in this case is the difference between what the United States paid and what it would have paid had Pinellas' claims been truthful. The court rejected the remaining challenges to the jury's verdict. The court further concluded that the monetary award imposed does not violate the Excessive Fines Clause. Finally, the court dismissed Pinellas' appeal as to the allocation of the monetary award between Ms. Yates and the United States. View "Yates v. Pinellas Hematology & Oncology, P.A." on Justia Law
Corman, J., et al. v. Beam
The Pennsylvania Supreme Court granted expedited review of this direct appeal to decide whether the Commonwealth Court erred in concluding that Acting Secretary of Health Alison Beam (“the Secretary”) lacked the power under existing law and Department of Health regulations to require individuals to wear facial coverings while inside Pennsylvania’s schools as a means of controlling the spread of COVID-19. Having determined that the Secretary exceeded her authority in issuing that directive, by per curiam order on December 10, 2021, the Court affirmed the lower court’s decision nullifying the mandate, and published this opinion expounding on its reasoning. View "Corman, J., et al. v. Beam" on Justia Law
Keystone Rx v. Bureau. of Workers’ Compensation
The Bureau of Workers’ Compensation Fee Review Hearing Office (“Hearing Office”) concluded that, in the fee review setting, a non-treating healthcare provider, like a pharmacy, could not challenge a utilization review (“UR”) determination that medications prescribed by a treating healthcare provider, such as a physician, but dispensed by the non-treating entity, were unreasonable and unnecessary for the treatment of a claimant’s work-related injury. The Commonwealth Court affirmed the Hearing Office’s order. However, after reaching this result, the intermediate court held that for UR procedures occurring in the future, when an employer, insurer or an employee requests UR, non-treating providers, such as pharmacies, had to be afforded notice and an opportunity to establish their right to intervene in the UR proceedings. While the Pennsylvania Supreme Court affirmed the Commonwealth Court’s result, it rejected its prospective holding that non-treating healthcare providers had to be given notice and an opportunity to intervene in UR proceedings. View "Keystone Rx v. Bureau. of Workers' Compensation" on Justia Law
In re: MCP No. 165, Occupational Safety and Health Admin., Interim Final Rule: COVID19 Vaccination and Testing, 86 Fed. Reg. 61402
In November 2021, 5he Occupational Safety and Health Administration (OSHA), the federal agency tasked with assuring a safe and healthful workplace, issued an Emergency Rule on COVID-19 Vaccination and Testing, 86 Fed. Reg. 61402. The rule does not require anyone to be vaccinated but allows covered employers—employers with 100 or more employees—to determine for themselves how best to minimize the risk of contracting COVID-19 in their workplaces. Employers may require unvaccinated workers to wear a mask on the job and test for COVID-19 weekly; they can require workers to do their jobs exclusively from home. Workers who work exclusively outdoors are exempt.
The next day, the Fifth Circuit stayed the rule pending judicial review; it renewed that decision in an opinion issued on November 12. Under 28 U.S.C. 2112(a)(3), petitions challenging the rule, filed in Circuits across the nation, were consolidated into the Sixth Circuit, which dissolved the stay issued by the Fifth Circuit. The language of its enabling act plainly authorizes OSHA to act on its charge “to assure safe and healthful working conditions for the nation’s workforce and to preserve the nation’s human resources.” OSHA’s issuance of the rule is not a transformative expansion of its regulatory power, The factors regarding irreparable injury weigh in favor of the government and the public interest. View "In re: MCP No. 165, Occupational Safety and Health Admin., Interim Final Rule: COVID19 Vaccination and Testing, 86 Fed. Reg. 61402" on Justia Law
Mercer v. Thomas B. Finan Center
The Court of Appeals held that an administrative law judge (ALJ) with the Maryland Office of Administrative Hearings erred in declining Petitioner's request to be represented by counsel at an administrative hearing regarding the approval to give Petitioner forced medication, holding that the ALJ erred.Petitioner, a patient at a psychiatric institution, refused to take prescribed psychotropic medication. After a panel approved forced medication, Petitioner requested a hearing. On the day of the hearing, Petitioner asked for counsel. The ALJ treated the request for counsel as a request for a postponement, concluding that there was not good cause to postpone the hearing, and convened the hearing with Petitioner unrepresented. The Court of Appeals reversed, holding (1) under the plain language of HG 10-708 an individual possesses a right to counsel upon request; (2) an on-the-record waiver colloquy of the kind required in a criminal case is unnecessary, but there must be verification that the individual has knowingly and voluntarily waived the right to counsel and elected to proceed without representation; and (3) the ALJ erred in declining Petitioner's request to be presented by counsel at the administrative hearing. View "Mercer v. Thomas B. Finan Center" on Justia Law
Clawson v. Board of Registered Nursing
Nina’s was a residential care facility for the elderly (RCFE) licensed by the Community Care Licensing Division (CCL) of the State Department of Social Services. Plaintiff, an RN-certified legal nurse consultant, was hired to assist with the closure of Nina’s and agreed to assess each of the residents and recommend a new facility, as required by RCFE closing procedures, Health and Safety Code 1569.682(a)(1)(A).Caregivers from the new RCFE, Frye’s, came to transfer J.N. They immediately noticed that J.N. was in significant pain; multiple bandages “stuck to [J.N.’s] skin and her wounds,” which “all smelled really bad.” J.N.’s toes were black. Frye’s caregivers called 911. J.N. died weeks later. A CCL investigator contacted plaintiff, who confirmed that he had performed J.N.’s assessment. Plaintiff later denied performing J.N.’s physical assessment, stating that Mia “was the one in charge.” He denied guiding or instructing Mia during the assessment, stating he only acted as a “scribe.” The ALJ found clear and convincing evidence that plaintiff committed gross negligence in connection with J.N.'s appraisal, unprofessional conduct in carrying out nursing functions in connection with the appraisal, and unprofessional conduct by not being truthful with the Board investigator regarding J.N.'s care provided.The court of appeal upheld the revocation of plaintiff’s nursing license. Substantial evidence supports the finding that plaintiff engaged in a “usual nursing function” when he performed J.N.’s resident appraisal. Plaintiff’s dishonesty during the investigation constitutes unprofessional conduct. View "Clawson v. Board of Registered Nursing" on Justia Law
Louisiana v. Becerra
The Secretary of DHS and other federal government defendants moved to stay the district court's nationwide, preliminary injunction barring enforcement of one of the federal COVID-19 vaccination mandates related to the staff of many Medicare- and Medicaid-certified providers such as hospitals, long-term care facilities, home-health agencies, and hospices.The Fifth Circuit denied the motion insofar as the order applies to the 14 Plaintiff States, concluding that the Secretary has not made a strong showing of likely success on the merits in light of BST Holdings, L.L.C. v. OSHA, 17 F.4th 604 (5th Cir. 2021). In BST, the Fifth Circuit relied in part on the "major questions doctrine" in staying the COVID-19 vaccination mandate OSHA issued for employers of a certain size. In this case, the Secretary identifies meaningful distinctions between its rule for Medicare and Medicaid-funded facilities and the broader OSHA rule — the statutory authority for the rule is different; Medicare and Medicaid were enacted under the Spending Clause rather than the Commerce Clause; and the targeted health care facilities, especially nursing homes, are where COVID-19 has posed the greatest risk. Nonetheless, the court concluded that the first stay factor requires more than showing a close call. Therefore, the court could not say that the Secretary has made a strong showing of likely success on the merits. Furthermore, the other three factors for a stay — injury to the movant, injury to the opponent, and the public interest — are important but, regardless of the outcome of analyzing them, they will not overcome the court's holding that the merits of the injunction will not likely be disturbed on appeal.Applying principles of judicial restraint, the court granted the stay as to the order's application to any other jurisdiction, concluding that the district court gave little justification for issuing an injunction outside the 14 States that brought this suit. View "Louisiana v. Becerra" on Justia Law