Justia Health Law Opinion Summaries

A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law

The case involves Planned Parenthood and two physicians challenging the Idaho Attorney General's interpretation of Idaho Code § 18-622(1), which criminalizes performing or attempting to perform an abortion and imposes professional licensing penalties on healthcare providers who assist in performing or attempting to perform an abortion. The Attorney General issued an opinion letter stating that the statute prohibits medical providers from referring patients to out-of-state abortion providers. Plaintiffs argued that this interpretation violates their First Amendment rights by preventing them from providing information about abortion services in other states.The United States District Court for the District of Idaho granted a preliminary injunction, preventing the Attorney General from enforcing his interpretation of the statute. The court found that the plaintiffs had standing, the case was ripe and not moot, and the Attorney General was a proper defendant under Ex parte Young. The court held that the plaintiffs were likely to succeed on the merits of their First Amendment claim and would suffer irreparable harm without an injunction.The United States Court of Appeals for the Ninth Circuit affirmed the district court's decision. The Ninth Circuit held that the plaintiffs had established Article III standing, as they demonstrated a credible threat of prosecution under the Attorney General's interpretation. The case was deemed ripe and not moot despite the Attorney General's withdrawal of the opinion letter, as the withdrawal did not disavow the interpretation. The court also held that the Attorney General was a proper defendant under Ex parte Young due to his authority to assist in the enforcement of the statute. The Ninth Circuit agreed with the district court that the plaintiffs were likely to succeed on the merits of their First Amendment claim and affirmed the preliminary injunction. The request for reassignment to a different district judge was denied. View "PLANNED PARENTHOOD GREAT NORTHWEST, HAWAII, ALASKA V. LABRADOR" on Justia Law

Dr. Fares Jeries Rabadi, a licensed physician in California, had his certificate of registration to dispense controlled substances revoked by the Drug Enforcement Administration (DEA). The DEA initiated an investigation into Rabadi in April 2018 due to his high-risk prescribing practices. In March 2020, the DEA issued an Order to Show Cause and Immediate Suspension of Registration, alleging that Rabadi issued numerous prescriptions for controlled substances outside the usual course of professional practice and not for a legitimate medical purpose to seven individuals. Rabadi requested a hearing before an administrative law judge (ALJ), which took place in September 2020. The ALJ found Rabadi's testimony not credible and recommended revoking his registration. The DEA Administrator adopted the ALJ's recommendations with minor modifications and revoked Rabadi's registration.Rabadi petitioned for review, arguing that the DEA's revocation was invalid because DEA ALJs are unconstitutionally insulated from removal by two layers of "for-cause" protections. The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that Rabadi's argument failed under Decker Coal Co. v. Pehringer, which found similar ALJ removal protections constitutional. The court noted that DEA ALJs perform purely adjudicatory functions, Congress does not mandate the use of ALJs for DEA hearings, and DEA ALJ decisions are reviewed de novo by the DEA Administrator, who is removable at will by the President.Rabadi also argued that the DEA Administrator's order was arbitrary and capricious. The court rejected this argument, finding that the Administrator properly ignored Rabadi's unsupported defense regarding high dosages of prescribed drugs and appropriately analyzed the public interest factors, including Rabadi's lack of a conviction record. The Ninth Circuit denied Rabadi's petition for review, upholding the DEA Administrator's order. View "RABADI V. USDEA" on Justia Law

The case involves the Hawai‘i Disability Rights Center (HDRC), which represents individuals with developmental disabilities, including children with autism. HDRC alleges that the Hawai‘i Departments of Education (DOE) and Human Services (DHS) unlawfully deny students with autism access to Applied Behavioral Analysis (ABA) therapy during school hours, even when medically necessary. DOE provides ABA services only if deemed educationally relevant, and DHS does not provide ABA services during school hours, even if medically necessary and covered by Medicaid or private insurance.The United States District Court for the District of Hawaii granted summary judgment in favor of DOE and DHS, holding that HDRC's failure to exhaust administrative procedures under the Individuals with Disabilities Education Act (IDEA) was fatal to all its claims, including those under the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, and the Medicaid Act. The court concluded that HDRC, as a protection and advocacy organization, must ensure that parents of its constituents exhaust the IDEA’s administrative process.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that HDRC, as Hawai‘i’s designated protection and advocacy system, can pursue administrative remedies under the IDEA and is therefore bound by the IDEA’s administrative exhaustion requirement for its own claim. However, HDRC need not ensure that parents of individual children with autism exhaust their individual IDEA claims. The court found that HDRC did not exhaust its administrative remedies, and no exceptions to IDEA exhaustion applied.The Ninth Circuit also held that HDRC was not required to exhaust the IDEA’s administrative procedures before bringing its claims under the ADA, Section 504, and the Medicaid Act. The court concluded that HDRC’s non-IDEA claims do not allege the denial of a free appropriate public education (FAPE) and therefore do not require exhaustion under the IDEA. The court affirmed in part, reversed in part, and remanded the case. View "HAWAI'I DISABILITY RIGHTS CRT. V. KISHIMOTO" on Justia Law

The case involves a challenge to Montana House Bill 702 (HB 702), which prohibits discrimination based on vaccination status. Plaintiffs, including health care providers and individuals with compromised immune systems, argued that HB 702 is preempted by the Americans with Disabilities Act (ADA) and the Occupational Health and Safety Act (OSH Act) and violates the Equal Protection Clause of the Fourteenth Amendment. They sought to invalidate HB 702 in all health care settings, claiming it prevents employers from knowing employees' vaccination status, thus hindering ADA-required accommodations and OSH Act compliance.The United States District Court for the District of Montana ruled in favor of the plaintiffs, holding that HB 702 is preempted by the ADA and the OSH Act and violates the Equal Protection Clause. The court issued a permanent injunction against the enforcement of HB 702 in health care settings, reasoning that the law conflicts with federal requirements for reasonable accommodations and workplace safety.The United States Court of Appeals for the Ninth Circuit reversed the district court's decision and vacated the injunction. The Ninth Circuit held that neither the ADA nor the OSH Act facially preempts HB 702 in health care settings. The court found that the plaintiffs did not demonstrate a genuine conflict between HB 702 and the ADA or OSH Act in any specific case, much less in all health care settings. The court also held that HB 702 does not violate the Equal Protection Clause, as the classification and differential treatment of facilities could rationally reflect Montana's interest in balancing personal privacy and public health.The Ninth Circuit reserved judgment on whether the ADA and the OSH Act could preempt HB 702 on a narrower, as-applied basis in future cases. The court deemed moot the portion of the district court's order related to interim CMS regulations, as those regulations have been rescinded. The court concluded that HB 702 is not facially invalid under the ADA, OSH Act, or Equal Protection Clause and vacated the district court's injunction in full. View "MONTANA MEDICAL ASSOCIATION V. KNUDSEN" on Justia Law

The case involves Sam Sarkis Solakyan, who owned multiple medical-imaging companies. Solakyan conspired with physicians and medical schedulers to route unsuspecting patients to his companies for unnecessary MRI scans and other medical services, generating $263 million in claims. The scheme involved bribery and kickbacks to physicians who referred patients to Solakyan’s companies, violating California’s anti-kickback statutes.The United States District Court for the Southern District of California presided over the initial trial. Solakyan was charged with conspiracy to commit honest-services mail fraud and health-care fraud, as well as substantive counts of honest-services mail fraud and aiding and abetting. After a seven-day trial, the jury found Solakyan guilty on all counts. The district court sentenced him to 60 months in prison and ordered him to pay $27,937,175 in restitution to the affected insurers.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed Solakyan’s conviction, holding that honest-services mail fraud under 18 U.S.C. §§ 1341 and 1346 includes bribery and kickback schemes that deprive patients of their right to honest services from their physicians. The court also held that actual or intended tangible harm is not an element of honest-services fraud. The indictment was found sufficient in alleging willful misconduct for health-care fraud. The court did not find any abuse of discretion in the jury instructions regarding the mens rea for the conspiracy charges or the use of mails in the fraud scheme. However, the court vacated the restitution order, remanding the case for further proceedings to determine if the restitution amount should be reduced by the cost of medically necessary MRIs that insurers would have paid for absent the fraud. View "USA V. SOLAKYAN" on Justia Law

The case involves doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF) by removing fat tissue from patients, processing it to concentrate stem cells, and then re-administering it to the same patients. The FDA inspected the clinics and found that the doctors were manufacturing and administering unapproved drug products, leading to a lawsuit alleging violations of the Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Central District of California held a bench trial and ruled in favor of the defendants. The court concluded that the SVF was not a "drug" under the FDCA and that the same-day SVF treatment fell under the "same surgical procedure" (SSP) exception, which exempts certain procedures from FDA regulation. The district court found that the cells in the same-day SVF were not altered chemically or biologically and that the procedure did not introduce any foreign material into the body.The United States Court of Appeals for the Ninth Circuit reviewed the case and reversed the district court's judgment. The appellate court held that the SVF constitutes a "drug" under the FDCA based on the plain text of the statute, which defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. The court also rejected the defendants' argument that their same-day SVF treatment was exempt from FDA regulation under the SSP exception. The court concluded that the SSP exception applies only if the removed and implanted human cells, tissues, and cellular and tissue-based products (HCT/Ps) are the same, and in this case, the removed fat tissue and the implanted SVF are not the same.The Ninth Circuit reversed the district court's judgment and remanded the case for further proceedings. View "USA V. CALIFORNIA STEM CELL TREATMENT CENTER, INC." on Justia Law

The case involves an encounter between the Hawai'i Police Department (HPD) and Steven Hyer, which resulted in Hyer's death. On June 22, 2018, HPD officers responded to calls about Hyer's erratic behavior. Hyer, who had a history of mental illness, barricaded himself in his apartment. After several hours of failed negotiations and attempts to subdue him, including the use of a Taser and chemical munitions, HPD officers deployed a police dog. When Hyer allegedly threatened the officers with a compound bow, Corporal Torres shot and killed him.The United States District Court for the District of Hawaii granted summary judgment in favor of the defendants, the City and County of Honolulu, and several HPD officers. The court excluded the plaintiffs' expert reports, finding them speculative, unreliable, and containing legal conclusions. The court ruled that the use of force was objectively reasonable and that the officers were entitled to qualified immunity. The court also dismissed the plaintiffs' claims under the Americans with Disabilities Act (ADA) and various state law claims.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that the district court erred in excluding the entirety of the plaintiffs' expert reports, as the reports were based on sufficient facts and data. The Ninth Circuit found that the exclusion of these reports was prejudicial because they created genuine disputes of material fact regarding the reasonableness of the use of deadly force and chemical munitions, as well as potential ADA violations. The court reversed the district court's summary judgment on these claims but affirmed the grant of qualified immunity regarding the use of the police dog, as the law was not clearly established. The case was remanded for further proceedings. View "HYER V. CITY AND COUNTY OF HONOLULU" on Justia Law

Artak Ovsepian participated in a healthcare fraud scheme at Manor Medical Imaging, Inc., a sham clinic in Glendale, California. The clinic generated prescriptions for unnecessary medications, which were billed to Medicare and Medi-Cal. Manor employees used the identifying information of Medicare and Medi-Cal beneficiaries, often without their knowledge, to fill these prescriptions. Ovsepian joined the conspiracy in 2010, managing drivers who transported beneficiaries to pharmacies to fill fraudulent prescriptions.The government charged Ovsepian with conspiracy to commit healthcare fraud and aggravated identity theft under 18 U.S.C. § 1028A(a)(1). At trial, the government narrowed the aggravated identity theft charge to the possession of one victim’s identifying information. The jury found Ovsepian guilty on all counts, and he was sentenced to 180 months, including a mandatory 24-month sentence for aggravated identity theft. Ovsepian’s direct appeals were unsuccessful, and the Supreme Court denied his petition for a writ of certiorari.Ovsepian filed a 28 U.S.C. § 2255 motion to vacate his aggravated identity theft conviction, arguing actual innocence. The district court denied the motion, and the Ninth Circuit initially denied a certificate of appealability. However, the Supreme Court remanded the case for reconsideration in light of Dubin v. United States, which clarified the interpretation of the aggravated identity theft statute.The Ninth Circuit reversed the district court’s denial of Ovsepian’s § 2255 motion. The court held that a petitioner convicted under a divisible statute must demonstrate actual innocence only for the prong under which they were convicted. The court found that the jury instructions were erroneous because they did not convey that possession of another’s identifying information must be central to the healthcare fraud to sustain a conviction. Consequently, the Ninth Circuit vacated Ovsepian’s conviction and sentence for aggravated identity theft. View "USA V. OVSEPIAN" on Justia Law

The case involves a coalition of states led by Washington suing the FDA over its 2023 REMS, which eliminated in-person dispensing requirements for the abortion drug mifepristone. Washington argues that the FDA should have further reduced restrictions on the drug, claiming that the remaining requirements impose unnecessary hurdles. Idaho, leading another coalition of states, sought to intervene, arguing that the elimination of the in-person dispensing requirement would harm its interests by making the drug easier to obtain and harder to police, potentially increasing Medicaid costs and endangering maternal health and fetal life.The United States District Court for the Eastern District of Washington denied Idaho's motion to intervene. The court found that Idaho did not have a significantly protectable interest that would be impaired by the litigation, as its complaint concerned different aspects of the 2023 REMS. The court also denied permissive intervention, concluding that Idaho's claims did not share common questions of law or fact with Washington's claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed the district court's denial of Idaho's motion to intervene as of right. The Ninth Circuit held that Idaho must independently satisfy the requirements of Article III standing because it sought different relief from Washington. The court concluded that Idaho's complaint did not establish a cognizable injury-in-fact that was fairly traceable to the FDA's revised safe-use restrictions. Idaho's alleged economic injuries, law enforcement burdens, and quasi-sovereign interests were deemed too speculative or indirect to confer standing. The court dismissed for lack of jurisdiction the portion of the appeal concerning the denial of permissive intervention. View "STATE OF WASHINGTON V. FDA" on Justia Law