Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Big Time Vapes, Inc. v. FDA
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. View "Big Time Vapes, Inc. v. FDA" on Justia Law
General Medicine, P.C. v. Azar
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. View "General Medicine, P.C. v. Azar" on Justia Law
Conservatorship of Jose B.
Objector, a conservatee subject to conservatorship under the Lanterman-Petris-Short Act, contested the petition to reappoint a public guardian as his conservator. On appeal, objector contends the trial court violated Welfare and Institutions Code section 5350, subdivision (d)(2), and denied him due process by failing to commence the jury trial within 10 days of his demand for trial.The Court of Appeal was deeply troubled by the significant delay of over four months in holding a trial on objector's petition, especially given the lack of any justification by the court for most of the delay. The court emphasized the statutory obligation of trial courts to hold a jury trial within 10 days, with only a limited exception for a 15-day continuance if requested by the proposed conservatee. However, the court held that the trial court's failure to commence trial within 10 days of the jury trial demand did not support dismissal of the petition. Rather, the time limit in section 5350, subdivision (d)(2), is directory, not mandatory, because the Legislature has not expressly provided for dismissal of the conservatorship petition if a trial is not held within 10 days. Furthermore, objector was not prejudiced and denied due process. Accordingly, the court affirmed the judgment. View "Conservatorship of Jose B." on Justia Law
Gass et al. v. 52nd Judicial District
At issue before the Pennsylvania Supreme Court was a challenge to a local judicial district’s policy prohibiting the use of medical marijuana by individuals under court supervision, such as probationers. Relevant here, the applicable statutory authority, the Pennsylvania Medical Marijuana Act, contained an immunity provision protecting patients from government sanctions. In September 2019, the 52nd Judicial District -- comprised of the Lebanon County Court of Common Pleas (the “District”) -- announced a “Medical Marijuana Policy” under the issuing authority of the president judge. The Policy prohibited “the active use of medical marijuana, regardless of whether the defendant has a medical marijuana card, while the defendant is under supervision by the Lebanon County Probation Services Department.” Petitioners were individuals under the supervision of the Lebanon County probation agency who filed suit in the Commonwealth Court's original jurisdiction to challenge the validity of the Policy in light of the MMA's immunity provision. Separately, Petitioners filed an application for special relief in the nature of a preliminary injunction. Soon thereafter, the Commonwealth Court proceeded, sua sponte, to transfer the case to this Court, concluding that it lacked jurisdiction to grant the requested relief. The District then filed its response in this Court opposing preliminary injunctive relief. It claimed, among other things, that Petitioners were unlikely to prevail on the merits, arguing, inter alia, that the General Assembly didn’t intend the MMA to override the courts’ ability to supervise probationers and parolees. After review, the Pennsylvania Supreme Court granted Petitioners' request for declaratory and injunctive relief. The Policy was deemed to be contrary to the immunity accorded by the MMA, and as such, should not be enforced. "[N]othing impedes a revocation hearing or other lawful form of redress, where there is reasonable cause to believe that a probationer or other person under court supervision has possessed or used marijuana in a manner that has not been made lawful by the enactment." View "Gass et al. v. 52nd Judicial District" on Justia Law
Merck & Co., Inc. v. United States Department of Human and Health Services
Drug manufacturers challenged the Department's rule that broadly requires drug manufacturers to disclose in their television advertisements the wholesale acquisition cost of many prescription drugs and biological products for which payment is available under Medicare or Medicaid.The DC Circuit affirmed the district court's judgment in favor of the drug manufacturers, holding that the Department acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs. The court explained that, in the overwhelming majority of cases, the price that the rule compels manufacturers to disclose bears little resemblance to the price beneficiaries actually pay under the Medicare and Medicaid programs. Therefore, the court held that there is no reasoned statutory basis for the Department's far-flung reach and misaligned obligations, and thus the rule is invalid and is hereby set aside. View "Merck & Co., Inc. v. United States Department of Human and Health Services" on Justia Law
Methodist Specialty Care Center v. Mississippi Division of Medicaid
Methodist Specialty Care Center was the only nursing facility for the severely disabled (NFSD) in Mississippi. NFSDs generally incur higher costs than other nursing facilities, and because of this, Methodist received a percentage adjustment to its new-bed-value (NBV) calculation when the Mississippi Division of Medicaid (DOM) determined how much it should reimburse Methodist for its property costs through the DOM’s fair-rental system. A NBV was intended to reflect what it would cost to put a new bed into service in a nursing facility today. Methodist had received a NBV adjustment of 328.178 percent added to the standard NBV every year since it opened in 2004 until State Plan Amendment (SPA) 15-004 was enacted. During the 2014 Regular Session, the Mississippi Legislature passed House Bill 1275, which authorized the DOM to update and revise several provisions within the State Plan; one such amendment changed Methodist's adjustment rate, and made the facility experience a substantial decrease in its NBV, while all other nursing facilities in the state received increases. Methodist appealed the DOM’s changes to its NBV that were enacted in SPA 15-004. After a hearing, an Administrative Hearing Officer (AHO) upheld the decreased percentage adjustment to Methodist’s NBV, but also determined the DOM had miscalculated Methodist’s NBV adjustment. The DOM had planned to calculate Methodist’s adjustment as 175 percent of the base NBV, but the AHO found that Methodist’s adjusted NBV should be calculated in the same manner as it was calculated preamendment - by taking 175 percent of the standard NBV and adding that value to the standard NBV. Methodist still felt aggrieved because its NBV adjustment rate had not been restored to the preamendment rate. Methodist appealed the DOM’s final decision to the Chancery Court. When the chancellor affirmed the DOM’s final decision, Methodist appealed to the Mississippi Supreme Court. After review, the Supreme Court found the DOM’s final decision was supported by substantial evidence, was not arbitrary or capricious, did not violate Methodist’s constitutional or statutory rights and that the DOM was acting within its power in reaching and adopting its final decision. View "Methodist Specialty Care Center v. Mississippi Division of Medicaid" on Justia Law
Shands Jacksonville Medical Center, Inc. v. Azar
The district court remanded the Fiscal Year 2014 Rule to the Secretary of Health and Human Services without vacating the Rule. The district court's decision was made in response to the challenge by a group of hospitals to a 0.2% reduction in Medicare reimbursement rates for inpatient hospital services. The Secretary subsequently increased the Medicare inpatient rates by 0.6% for Fiscal Year 2017 to offset the past effects of the abandoned rate reduction.The DC Circuit affirmed the district court's grant of summary judgment for the Secretary. The court held that the district court was not required to vacate the Rule or order make whole relief as the hospitals sought, and the remedy on remand reasonably addressed the problem. The court also held that the district court did not err in partially granting and denying statutory interest to certain hospitals in accord with this court's precedent. Finally, the court affirmed the partial award and denial of statutory interest. View "Shands Jacksonville Medical Center, Inc. v. Azar" on Justia Law
Mississippi Division of Medicaid v. Windsor Place Nursing Center, Inc. et al.
The Mississippi Division of Medicaid (DOM) appealed a chancery court judgment ordering the DOM to reverse the adjustments for “Legend Drug” costs reported by Windsor Place Nursing Center, Inc., d/b/a Windsor Place Nursing & Rehab Center (Windsor) and Billdora Senior Care, Lexington Manor Senior Care, and Magnolia Senior Care (collectively Senior Care). The chancery court found that legend drug expenses incurred by these providers were properly reported on each of their Long Term Care (LTC) cost reports as an allowable cost and should have been taken into account the by DOM in determining the per diem rates for each provider. The DOM contends that its decision to disallow the legend drug expenses claimed by the providers in their required cost report for reporting years 2005, 2007, and 2008 was supported by substantial evidence, was not arbitrary or capricious, and was within its authority to decide. Therefore, the chancery court’s order must be reversed and the DOM’s decision must be reinstated. The Mississippi Supreme Court agreed with the DOM. "No where in the controlling statutes, the state plan, or Medicaid’s policy do we see language that lends itself to a construction taken by the providers that all prescription drug costs “not covered” by the Medicaid drug program means drug costs 'not paid for' by Medicaid. ... While the DOM may have failed to catch this in the past, legend drugs covered by Medicaid’s Drug Program are subject to direct reimbursement from Medicaid to the dispensing pharmacist, and constitute a non-allowable cost for the provider’s pier diem reimbursement report. And any action taken to the contrary by Medicaid is a violation of its rules and regulations." View "Mississippi Division of Medicaid v. Windsor Place Nursing Center, Inc. et al." on Justia Law
Wisconsin Legislature v. Palm
The Supreme Court held that Andrea Palm's order confining all people to their homes, forbidding travel, and closing businesses in response to the COVID-19 coronavirus (Emergency Order 28) was unenforceable because the order was a rule, and Palm did not follow statutory emergency rule making procedures established by the Legislature.On March 12, 2020, Governor Tony Evers issued Executive Order 72 proclaiming that a public health emergency existed in Wisconsin and directed DHS to take "all necessary and appropriate measures" to prevent incidents of COVID-19 in the State. On March 24, Palm, as secretary-designee of the Department of Health Services, issued Emergency Order 12 ordering Wisconsin citizens to stay at home. On April 16, Palm issued Emergency Order 28 ordering individuals to stay at home or risk punishment. The Wisconsin Legislature brought an emergency petition for original action asserting that Palm failed to follow emergency rulemaking procedures required under Wis. Stat. 227.24. The Supreme Court held (1) Emergency Order 28 is a "rule" under Wis. Stat. 227.01(13); (2) because Palm did not follow rulemaking procedures during Order 28's promulgation, there could be no criminal penalties for violations of her order; and (3) Palm's order further exceeded the statutory authority of Wis. Stat. 252.02. View "Wisconsin Legislature v. Palm" on Justia Law
Wingfield v. Department of Public Health & Human Services
The Supreme Court affirmed the order of the district court granting the Montana Department of Public Health and Human Services' (DPHHS) motion for judgment on the pleadings, holding that the district court did not err in concluding that guardians had the authority to decide whether their wards would return to the At Home Assisted Living and At Home Also (collectively, At Home) facility.In 2017, the DPHHS suspended At Home's license for noncompliance with certain DPHHS rules and regulations and required the At Home residents to be relocated. After DPHHS reinstated At Home's license, some relocated residents who were wards with guardians appointed by DPHHS Adult Protection Services indicated their desire to return to the facility. The APS guardians refused to allow their wards to return. At Home and its owners sued DPHHS alleging intentional interference. The district court granted judgment on the pleadings for DPHHS. The Supreme Court affirmed, holding that the district court did not err in determining that the guardians had the authority to determine where the wards would reside and in thus granting judgment on the pleadings. View "Wingfield v. Department of Public Health & Human Services" on Justia Law