Healthcare
Healthcare
The Sixth Circuit reasoned that the alleged harm was not the “predictable effect” of the government agencies’ alleged overstatement of COVID-19 case and death data; therefore, enjoining the government agencies would not have provided any redress. The...
Finding injunctive relief was neither ripe for review nor warranted under the circumstances, the court denied the pharmacy’s application for preliminary injunction. In an unpublished opinion, a New Jersey district court denied a veterinary compoundin...
Pharmaceutical company was not entitled to recover attorneys' fees in a patent infringement action which was voluntarily dismissed by pharmaceutical company that had alleged patent infringement. A federal district court has granted the motion to dism...
The surviving spouse will have additional time to conduct discovery and amend his petition involving claims arising from the death of his wife, allegedly caused by a malfunctioning insulin pump. The Western District of Louisiana granted Tandem Diabet...
The final guidance focuses on safety aspects of the container label and carton labeling design for human prescription drug and biologic products. As of 2006, thirty-three percent of medication errors and thirty percent of fatalities from medication e...
The medical gas industry will have new or modified regulations specifically focused on their industry under the FDA’s proposal. The FDA is proposing to amend regulations impacting the requirements for current good manufacturing practice (CGMP) and po...
An ALJ upheld a CSM determination to revoke billing privileges of an ambulance service when it failed to terminate the fire chief due to an unreported felony conviction. An administrative law judge (ALJ) sustained a determination of a Medicare contra...
New Surgeon General Advisory lays out recommendations to address health care worker burnout and resignation that has been exacerbated by the COVID-19 pandemic. A recent advisory issued by the U.S. Surgeon General Dr. Vivek Murthy highlights the urgen...
This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates. New proposed rules. No new proposed rules have been issued since May 16, 2022. See the Regulation Tracker for details. New final ...
Healthcare
The wholesale pharmaceutical distributors plausibly alleged that a private entity violated their due process right under New Jersey common law. The U.S. Court of Appeals for the Third Circuit affirmed the district court’s dismissal of §1983 claims an...
Because there was conflicting evidence as to when the patient’s injuries were reasonably ascertainable, the question of when her claim accrued was best left to a jury, the court held. Product liability claims arising from injuries sustained by the im...
Friction might have caused metal debris to accumulate within the joint and bloodstream of the patient, but the court concluded the manufacturer did not know enough at the time to have caused the consumer to make a bad choice. The district court in Ba...
Because podiatrists are not, by statute, qualified to refer patients to the Medical Marijuana Program, disabled podiatrist’s discrimination suit was dismissed. In a non-binding opinion, the Third Circuit upheld a district court’s dismissal of a New J...
DAB dismissed an unacceptable amended complaint seeking review of an NCD excluding transvenous (catheter) pulmonary embolectomy from Medicare coverage because the complaint was not submitted by an “aggrieved party” and was not accompanied by a physic...
The Social Security Administration produced insufficient evidence of an alleged debt with its aged computer record keeping system for payroll. Concluding that the Social Security Administration (SSA) failed to provide sufficient documentary evidence,...
Unwinding the COVID-19 public health emergency continuous coverage requirement too quickly could cause inappropriate terminations in violation of federal law. Information issued by CMS attempts to refresh the states’ awareness that they are still obl...
Several states are strengthening long-standing protections for abortion rights, seeking to assure affordable access, and protecting clinicians and patients seeking care within their borders. In light of the May 2, 2022, draft leak of the Supreme Cour...
Healthcare
About one quarter of Medicare patients discharged from hospitals in October 2018 experienced harm events and required treatment that led to additional Medicare costs; forty-three percent of the events were preventable. The HHS Office of Inspector Gen...
Consumer’s false and deceptive advertising claims largely survive retailer’s motion to dismiss. ALDI, Inc.’s motion to dismiss a consumer’s proposed class action lawsuit that alleged the “Simple. Sustainable. Seafood.” mark on its Atlantic salmon pro...
The association, whose members are anonymous, challenged the federal entities’ implementation and interpretation of Title VII and Section 1557 of the ACA. A federal court in North Dakota granted a religious employer alliance’s motion for a preliminar...
A consumer narrowly escaping defeat was given one more chance to amend its complaint to adequately plead a violation of California’s consumer protection laws. A federal court in California dismissed a consumer’s complaint which argued a manufacturer ...
Under the Medicare Secondary Payer Act, an assignee has standing to sue if its ultimate assignor suffered an injury in fact, and the assignor's claim arising from that injury was validly assigned. A federal district court in Florida has denied in par...
The accumulator adjustment rule as revised in 2020, which was set to take effect on January 1, 2023, required that manufacturers “ensure[] the full value of the assistance or benefit is passed on to the consumer or patient” for any financial assistan...
The week’s most insightful, intriguing, or entertaining blog posts from the health law community: FDA Law Blog: FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act , by Kurt R. Karst The Commonwealth Fund: Expanding Access to Eq...
While several factors influence vaccination rates, researchers suggest that the federal vaccine mandate may have caused an overall increase in staff vaccinations without leading to a drop in staffing. The Kaiser Family Foundation (KFF) has issued a r...
Healthcare
The CBO report, prepared in conjunction with the Joint Committee on Taxation, presented a dizzying array of likely rearrangements of the health insurance choices that people between ages 60 and 65 would make if they became eligible for Medicare. The ...
Without establishing an injury-in-fact from the data breach, patients lacked standing to bring suit to collect damages from provider. A provider who failed to safeguard electronic protected health information (e-PHI) of 300,000 patients escaped respo...
Where long-term care facilities faced with fair housing claims disregarded multiple discovery requests, they waived their right to object to discovery and were liable for the expenses of bringing the motion to compel. A federal district court in Loui...
Only the Office of Personnel Management (OPM) has authority to hear appeals of agency classification decisions. While an administrative law judge (ALJ) expressed concerns that HHS did not afford a mental health officer proper appeal rights, the ALJ c...
According to an HHS Office of Inspector General (OIG) audit, the Washington State Health Care Authority incorrectly used fee-for-service reimbursement rates instead of the managed-care capitation payments attributable to managed health home services,...
The FDA plans to consider, on a case-by-case basis, the temporary exercise of enforcement discretion from certain statutory and regulatory requirements to allow importation of infant formula. The FDA has released guidance to help increase the supply ...
Healthcare
While the guidance does not have the force of law, CMS believes it will help states provide clarity to the public regarding federal COVID-19 vaccine services. CMS has released guidance to states to help both administrators and the public better under...
Despite mootness of other trial issues, the court remanded the case back to the trial court to determine which portions of the record were properly to remain sealed. The Oregon Court of Appeals has dismissed as moot the appeal filed by the Oregon Med...
The court resolved that the state was trying to improperly reduce skilled nursing hours based on whether each child’s home caregiver was able to provide those services rather than based on medical necessity. In this civil rights class action against ...
The Board found that the Medicare contractor properly offset the supplemental pool payments that providers received from the Maine Medicaid program during FY 2012. The Provider Reimbursement Review Board (Board) found that the Medicare contractor pro...
Disagreeing with a Medicare contractor’s finding that an MDH was not eligible for a volume decrease adjustment payment, the PRRB remanded for VDA calculation. A Medicare Dependent Hospital (MDH) successfully challenged a Medicare contractor’s decisio...
The physician continued to bill Medicare while her license was suspended and failed to report her license suspension. An Administrative Law Judge (ALJ) has affirmed a three-year enrollment bar for a physician in Illinois who continued to bill Medicar...
The HHS Office of Inspector General’s (OIG) Work Plan—the list of agency audits, evaluations, and inspections that are planned or underway—is adjusted throughout the year to meet changing agency priorities. The OIG has issued Work Plan updates for Ma...