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TOP STORY—D.C. Cir.: No judicial review of agency determination in the absence of filed reimbursement claim

“Channeling” requirement that Provider receive denial of concrete claim for reimbursement before filing for judicial review applied even to PHE Telehealth services. A federal appeals court in the District of Columbia has affirmed the decision of the ...

TOP STORY—D.C. Cir.: No judicial review of agency determination in the absence of filed reimbursement claim
HEALTH CARE REFORM—6th Cir.: Hospital fails to dismiss ACA discrimination claim as time-barred
January 20, 2022
Susan L. Smith, JD, MA

A deaf patient’s discrimination claim brought under the Patient Protection and Affordable Care Act for failure to provide an interpreter will proceed. The district court properly determined that a deaf man’s claim of discrimination for failure to pro...

MEDICAID—5th Cir.: State met Medicaid obligations in decree, correction action order
January 20, 2022
Sara Cracau, J.D.

District court did not abuse its discretion in finding that the state had met its outreach and information obligations in the decree and corrective action order in connection with action alleging violations in Medicaid program. The U.S. Court of Appe...

MEDICAL DEVICES—S.D. Ala.: Faulty mesh implant suit against Ethicon dismissed as time-barred
January 20, 2022
Robert B. Barnett Jr., J.D.

Suit was filed more than two years after the tort claim arose and more than four years after the warranty claims arose. Products liability and warranty claims arising from a failed mesh implant were dismissed as time-barred, an Alabama federal distri...

SKILLED NURSING FACILITIES—DAB DECISIONS: Fine upheld against skilled nursing facility for intentionally locking out a resident
January 20, 2022
Sherri M. Schroeder, J.D.

The $10,205 fine against Redwood Healthcare Center was imposed for violating a Medicare participation requirement that prohibits the use of abuse or involuntary seclusion against residents of a skilled nursing facility. The undisputed facts of this c...

ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: Discount program enrollment allowed to add Medicaid enrollment as basis
January 20, 2022
Joe Cox, J.D.

A large pharmacy, which is enrolled with Medicaid programs in approximately 23 states, was allowed to add Medicaid enrollment as a basis for membership in their discount programs, even though their proposal would violate the anti-kickback statute and...

Healthcare

TOP STORY—Alaska Sup. Ct.: Vicarious Liability instruction to jury erroneous in HIPPA breach of contract case

Jury instruction to determine whether employee acted within course and scope of employment when she disclosed the patient’s private health information, was erroneous where patient brought a breach of contract claim against the hospital. The Supreme C...

TOP STORY—Alaska Sup. Ct.: Vicarious Liability instruction to jury erroneous in HIPPA breach of contract case
EMTALA—N.D. Cal.: Court denies EMTALA plaintiff’s motion to strike hospital’s answer
January 19, 2022
Robert Margolis, J.D.

Common law and state statutory affirmative defenses could apply to EMTALA claims, despite it being a strict liability statute. A federal district court in California has denied a patient’s motion to strike the general denials and all affirmative defe...

PREEMPTION OF STATE LAW—N.D. Ill.: State law claims by lab against insurer in payment dispute dismissed
January 19, 2022
Kenneth H. Ryesky, M.B.A., J.D.

Medicare Act broadly preempts state law provisions. A federal district court in Illinois dismissed a specialized urine testing laboratory's state law claims against an insurance carrier who had withheld payments to the lab for claims the insurer deni...

PRODUCTS LIABILITY (DEVICES)—D. Md.: Recipient of artificial hip implant denied new trial
January 19, 2022
Kenneth H. Ryesky, M.B.A., J.D.

A new trial was denied to a hip implant recipient where the evidence and testimony were proper. A district court in Maryland denied a new trial to a woman who claimed injury from a surgically-implanted artificial hip device. At trial, the jury found ...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—OIG REPORTS: OIG found states deficient in nursing home surveys
January 19, 2022
Gregory Kane, J.D., M.B.A.

A report by the OIG found that CMS should act to address states that fail to survey nursing home performance. The HHS Office of the Inspector General (OIG) published a report on their review of CMS oversight of state survey agencies conducting survey...

PRESCRIPTION DRUGS—OTHER AGENCY DOCUMENTS: ASPE report contemplates struggles of Medicare beneficiaries to afford prescriptions
January 19, 2022
Joe Cox, J.D.

The report indicates that more than 5 million beneficiaries struggle to afford medications, particularly in minority populations, and recommends Medicare Part D changes to lighten this burden. The Office of Health Policy’s Assistant Secretary for Pla...

Healthcare

TOP STORY: CMS updates deadlines for compliance with vaccine mandate

The only state not currently subject to the mandate is Texas. Health care workers in the 24 states where the U.S. Supreme Court reinstated CMS’ vaccine mandate must have their first shot by February 14 and be fully vaccinated by March 15, according t...

TOP STORY: CMS updates deadlines for compliance with vaccine mandate
ANTITRUST—S.D.N.Y.: Shkreli liable for disgorgement of Vyera's excess profits in Daraprim suit.
January 18, 2022
Kenneth H. Ryesky, M.B.A., J.D.

The incarcerated mastermind of the Daraprim price gouging scheme is also banned for life from the pharma industry. The federal district court in New York City has banned Martin Shkreli, the former CEO of Vyera Pharmaceuticals, LLC (Vyera) who is now ...

FALSE CLAIMS ACT—W.D. Tex.: Magistrate judge finds relator’s claims found sufficient to move forward
January 18, 2022
Joe Cox, J.D.

The magistrate judge recommended denying a health care provider’s motion to dismiss a qui tam suit which alleged improper Medicaid billing, finding that the relator had sufficiently pled her claims to allow the case to move ahead. This suit arises fr...

PRODUCTS LIABILITY (DEVICES)—D.N.J.: Motion to remand action by class of patients against breast implant manufacturer denied
January 18, 2022
Sara Cracau, J.D.

Court finds that clarification of citizenship at the time of filing of action and at the time the request for removal was filed is an acceptable reason to amend notice of removal past 30-day period. A federal district court in New Jersey denied a mot...

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: DAB affirms later effective date for billing purposes because of incomplete Medicare enrollment applications
January 18, 2022
Donielle Tigay Stutland, J.D.

The CMS contractor properly established the effective date for billing privileges of a practitioner, even though the practitioner had begun offering services earlier, as his earlier enrollment applications had been rejected. A CMS contractor correctl...

HEALTH CARE REFORM NEWS: Trends in the small-group insurance market show 'relative stability'
January 18, 2022
George Basharis, J.D.

The small-group insurance market continues to be an important source of health insurance since the implantation of the ACA. The Urban Institute has published the results of a study on current trends in the small-group insurance market for the years 2...

PHARMACEUTICAL NEWS: FDA approves first monoclonal antibody drug treatment for any animal species
January 18, 2022
Gregory Kane, J.D., M.B.A.

The FDA announced first of its kind approval of monoclonal antibody drug treatment for osteoarthritis pain in cats. The Food and Drug Administration (FDA) announced the approval of Solensia, the first treatment for the control of pain associated with...

Healthcare

TOP STORY—6th Cir.: Government shutdown order not a ‘physical loss’ to trigger insurance coverage of business losses

Kentucky Supreme Court was predicted to agree that an average person would not deem a COVID-19 mandate to be a tangible deprivation of property. A dentist whose practice lost income during a six-week shutdown for routine visits as mandated by the sta...

TOP STORY—6th Cir.: Government shutdown order not a ‘physical loss’ to trigger insurance coverage of business losses
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January 14, 2022

Health Law Daily will not publish Monday, January 17, due to the Martin Luther King, Jr. holiday. We will resume publication on Tuesday, January 18, with the extensive case and news coverage you’ve come to expect. Info

ANTI-KICKBACK PROHIBITION—9th Cir.: Safe harbor provision of anti-kickback statute does not violate the non-delegation doctrine
January 14, 2022
Wendy Biddle, J.D.

Congress gave instructions that were specific for HHS to consider, going beyond Supreme Court requirements. The Ninth Circuit Court of Appeals affirmed the convictions of three individuals who conspired to violate the Anti-Kickback Statute, finding t...

FALSE CLAIMS ACT—S.D.N.Y.: ‘Location of operative facts’ not determinative for transfer where alleged conduct was nationwide
January 14, 2022
Jeffrey H. Brochin, J.D.

Although Omnicare’s headquarters were in Ohio, there was no location deemed the “center of gravity of the litigation” where the false claims complained of were carried out from 147 pharmacies nationwide. A federal district court in New York has denie...

MEDICAID—D. Idaho: Federal court dismisses suit regarding adult caregiver exemption in Idaho for lack of jurisdiction
January 14, 2022
Donielle Tigay Stutland, J.D.

A suit brought in federal court to challenge an Idaho determination that the adult child caregiver exception to prohibited transfers under Idaho’s Medicaid Asset Transfer Penalty did not apply was dismissed for lack of federal jurisdiction, as a dete...

OTHER AGENCY DOCUMENTS: HRSA publishes guidelines to improve healthcare for women and children
January 14, 2022
Donielle Tigay Stutland, J.D.

HRSA updated the Women’s Preventive Services Guidelines in late 2021 to expand preventive coverage for women under the ACA, including adding a provision regarding obesity screening. The Health Resources and Services Administration (HRSA) of the HHS a...

HEALTH CARE REFORM—OTHER AGENCY DOCUMENTS: While private insurance deductibles are trending higher, Marketplace enrollees are seeing decreases
January 14, 2022
Sherri M. Schroeder, J.D.

A recent ASPE Brief assesses trends in deductibles among 2017–2021 HealthCare.gov enrollees and discusses the effects of the American Rescue Plan on coverage. An Issue Brief by the Office of Health Policy within HHS’s Assistant Secretary for Planning...

HEALTH CARE REFORM NEWS: Commonwealth Fund report indicates that working families shoulder an increasing health insurance cost burden
January 14, 2022
Kristofer Ray, PhD

Report finds that workers in thirty-seven states have premiums and deductibles that take up ten percent or more of their income. The Commonwealth Fund has released a state-by-state analysis of healthcare costs in the United States. Although employer ...

Healthcare

TOP STORY: Supreme Court stays injunctions that barred enforcement of CMS vaccine mandate

According to the Court, ensuring that providers take steps to avoid transmitting a “dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm.” The U.S. Supreme Court, ruling 5-4, has ...

TOP STORY: Supreme Court stays injunctions that barred enforcement of CMS vaccine mandate
FALSE CLAIMS ACT—E.D. Pa.: Nurse's FCA complaint against residential treatment facility dismissed
January 13, 2022
Kenneth H. Ryesky, M.B.A., J.D.

FCA claims for worthless services billing were not supported. A federal district court in Pennsylvania dismissed a nurse's False Claims Act (FCA) complaint that alleged Medicare and Medicaid billings for services not provided by the healthcare facili...

HEALTH CARE EMPLOYMENT ISSUES—D.R.I.: Rhode Island healthcare workers’ bid to enjoin enforcement of state’s COVID-19 mandate nixed
January 13, 2022
Kathleen Kapusta, J.D.

“Courts in this country have held for over a century that mandatory vaccination laws are a valid exercise of a state’s police powers, and such laws have withstood constitutional challenges.” Refusing to enjoin enforcement of an emergency regulation i...

HEALTH CARE EMPLOYMENT ISSUES—U.S.: OSHA large employer COVID vaccine mandate stayed
January 13, 2022
Kathleen Kapusta, J.D.

Ordering 84 million Americans to either obtain a COVID-19 vaccine or undergo weekly medical testing at their own expense, is a “significant encroachment into the lives—and health—of a vast number of employees.” Finding that the states, businesses, an...

MEDICAL DEVICES—S.D. Ohio.: Prior multidistrict litigation decisions on expert testimony remain on remand
January 13, 2022
Gregory Kane, J.D., M.B.A.

Motions to exclude expert testimony in pelvic mesh product liability suit find same results as during multidistrict litigation under law of the case doctrine. Five motions to exclude trial testimony of certain experts in a product liability lawsuit f...

FOOD STANDARDS—FINAL RULES: Oh la la: ‘French dressing’ gets a new look from the FDA
January 13, 2022
Sherri M. Schroeder, J.D.

In a final rule effective February 14, 2022, the FDA is revoking the standard of identity for French dressing. In response to a citizen petition, the FDA revokes the FDA’s standard of identity for French dressing. Concluding that the standard no long...

FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: DOJ settles with home healthcare agency on improper nursing services’ Medicaid claims
January 13, 2022
Sara Cracau, J.D.

The Department of Justice entered into a settlement agreement with an Ohio home health care agency to settle claims for group setting nursing services improperly submitted to Medicaid as individual services, resulting in greater reimbursement than du...

COVID-19—OTHER AGENCY DOCUMENTS: Labor, HHS, and Treasury respond to recent COVID-19-related statutory questions
January 13, 2022
Kristofer Ray, PhD

Guidance clarifies that individuals who purchase over the counter COVID-19 tests (OTC tests) can seek reimbursement from their insurance provider. The Departments of Labor, HHS, and the Treasury (the departments) have addressed frequently asked quest...