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Healthcare

TOP STORY—6th Cir.: Citizens’ alleged constitutional, reputational injuries affirmed not “fairly traceable” to faulty COVID-19 government data

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...

TOP STORY—6th Cir.: Citizens’ alleged constitutional, reputational injuries affirmed not “fairly traceable” to faulty COVID-19 government data
FOOD & DRUG INSPECTIONS—D.N.J.: Veterinary pharmacy denied injunction to prevent FDA from issuing notice of inspection results
May 23, 2022
Chelsea N. Simms, Esq.

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 In an unpublished opinion, a New Jersey district court denied a veterinary compoundin...

GENERIC DRUGS—D.N.J.: Pharmaceutical company not entitled to attorneys' fees in dismissed patent infringement action
May 23, 2022
Sara Cracau, J.D.

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...

PRODUCTS LIABILITY (DEVICES)—W.D. La.: Court grants time for additional discovery in case involving reconditioned insulin pump
May 23, 2022
Victoria Moran, J.D., M.H.A.

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...

LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—FDA GUIDANCE NOTICES: FDA issues guidance on proper labeling of prescription drug products to avoid medication errors
May 23, 2022
Martin A. Steinberg, J.D.

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...

DRUGS AND BIOLOGICS—PROPOSED RULES: FDA proposes regulations for medical gas industry under pressure of safety concerns
May 23, 2022
Cathleen Calhoun, J.D.

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...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Demotion to employee doesn’t constitute termination of business relationship for purposes of revocation reversal
May 23, 2022
Robert Patterson, M.J., J.D., LL.M

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...

GENERAL HEALTH CARE NEWS—HHS indicates failure to act on health worker burnout will place nation’s health at risk
May 23, 2022
Sherri M. Schroeder, J.D.

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...

REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments
May 23, 2022
WK Editorial Staff

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

TOP STORY—3rd Cir.: Wholesale pharmaceutical distributors’ New Jersey common law due process claim proceeds

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...

TOP STORY—3rd Cir.: Wholesale pharmaceutical distributors’ New Jersey common law due process claim proceeds
MEDICAL DEVICES—D. Kan.: Pelvic mesh claims not barred by statute of limitations, but failure-to-warn theory fails to survive summary judgment
May 20, 2022
Nicholas Kaster, J.D.

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...

MEDICAL DEVICES—D. Md.: Risk and detrimental effect of metal ions unknown until years after consumer chose implant
May 20, 2022
Justin Marcus Smith, J.D.

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...

PRESCRIPTION DRUGS—3rd Cir.: Disabled podiatrist disqualified from referring patients to Medical Marijuana Program cannot claim discrimination*
May 20, 2022
Chelsea N. Simms

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...

COVERAGE—DAB DECISIONS: A Medicare beneficiary may not challenge an NCD based on speculative future need
May 20, 2022
Sherri M. Schroeder, J.D.

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...

HEALTH CARE EMPLOYMENT ISSUES—DAB DECISIONS: SSA failed to show that employee owes debt for salary overpayment
May 20, 2022
Brian Craig, J.D.

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,...

COVID-19—OTHER AGENCY DOCUMENTS: CMS cautions states to take care with renewals when COVID-19 public health emergency ends
May 20, 2022
Justin Marcus Smith, J.D.

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...

STATE LEGISLATION NEWS—KFF brief highlights state actions to protect and expand abortion access
May 20, 2022
Kristofer Ray, PhD

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

TOP STORY—OIG REPORTS: OIG releases findings of study into adverse events experienced by hospitalized patients

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...

TOP STORY—OIG REPORTS: OIG releases findings of study into adverse events experienced by hospitalized patients
FOOD—N.D. Ill.: ALDI’s “sustainable” label for salmon faces class action
May 19, 2022
Leah S. Poniatowski, J.D.

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...

HEALTH CARE EMPLOYMENT ISSUES—D. N.D.: EEOC, HHS enjoined from enforcing gender transition care requirements on Christian employers alliance members
May 19, 2022
Brandi O. Brown, J.D.

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...

LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Cali.: Though skeptical valid claims exist, court allows consumer to amend dismissed complaint
May 19, 2022
Chelsea N. Simms, Esq.

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 ...

MEDICARE PART C/MEDICARE ADVANTAGE—S.D. Fla.: Conditional payment collection service had standing to assert injury suffered by its assignor
May 19, 2022
Jeffrey H. Brochin, J.D.

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...

PRESCRIPTION DRUGS—D.D.C.: Court sets aside HHS rule concerning calculating Medicaid prescription drug rebates
May 19, 2022
David Yucht, J.D.

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...

BLOG TRACKER—Noteworthy blog posts and other commentary
May 19, 2022
WK Editorial Staff

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...

HEALTH CARE COMPLIANCE NEWS: Kaiser Family Foundation analyzes COVID-19-era rates of nursing facility staff vaccinations, boosters, shortages
May 19, 2022
Kristofer Ray, PhD

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

TOP STORY—CBO REPORTS: Lowering Medicare eligibility to 60 would increase federal budget deficit by $155 billion

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 ...

TOP STORY—CBO REPORTS: Lowering Medicare eligibility to 60 would increase federal budget deficit by $155 billion
ELECTRONIC HEALTH RECORDS—S.D. N.Y.: Patients’ inability to establish standing leads to dismissal of class action lawsuit following data breach
May 18, 2022
Chelsea N. Simms, Esq

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...

LONG-TERM CARE FACILITIES—M.D. La.: COVID-19 pandemic not “good cause” for ignoring discovery requests for eight months
May 18, 2022
Jeffrey H. Brochin, J.D.

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...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Mental health counselor was overpaid based on retroactive reclassification
May 18, 2022
Brian Craig, J.D.

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...

AUDITS AND MONITORING—OIG REPORTS: Washington failed to comply with federal and state Medicaid managed-care health home service expenditures requirements
May 18, 2022
Martin A. Steinberg, J.D.

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,...

AGENCY NEWS—FDA exercises enforcement discretion from certain requirements to increase supply of infant formula
May 18, 2022
Elena Eyber, J.D.

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

TOP STORY—CMS Letters: CMS issues guidance for Medicaid and CHIP coverage of “stand-alone vaccine counseling”

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...

TOP STORY—CMS Letters: CMS issues guidance for Medicaid and CHIP coverage of “stand-alone vaccine counseling”
ENFORCEMENT ACTIONS—Or. App.: Court’s rational for closing proceedings did not extend to sealing of all records prospectively
May 17, 2022
Jeffrey H. Brochin, J.D.

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...

MEDICAID—N.D. Ga.: State Medicaid program permanently enjoined from reducing skilled home nursing hours of specific children
May 17, 2022
Justin Marcus Smith, J.D.

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 ...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—PRRB Decisions: Medicare contractor properly offset supplemental pool payments provider received from Medicaid
May 17, 2022
Sara Cracau, J.D.

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...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—PRRB DECISIONS: Rural Medicare dependent hospital entitled to calculation of volume decrease adjustment
May 17, 2022
Chelsea N. Simms

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...

MEDICARE PARTICIPATION—DAB DECISIONS: Physician’s three-year enrollment bar affirmed for abuse of Medicare billing privileges
May 17, 2022
Brian Craig, J.D.

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...

HEALTH CARE COMPLIANCE NEWS—OIG Work Plan updates for May 2022
May 17, 2022
WK Editorial Staff

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...