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Court Enjoins CMS From Enforcing Dissatisfaction Requirement When a Provider’s Appeal Stems from the MAC’s Failure to Issue a...

On August 6, 2014, the United States District Court for the District of Columbia enjoined CMS, its Medicare Administrative Contractors (MACs), and the Provider Reimbursement Review Board (PRRB) from applying the...more

First Circuit Rules in Favor of Dialysis Operator in Tax Dispute

On August 13, 2014, the United States Court of Appeals for the First Circuit affirmed a district court’s judgment in a tax dispute proceeding that Fresenius Medical Care Holdings, Inc. (Fresenius) was entitled to more than...more

Maine Workers' Compensation Alert: CMS Guidelines Amended to Accept WCB Settlement Determination of MSA Amount After Hearing on...

The Center for Medicare and Medicaid Services (CMS) update to its Workers' Compensation Medicare Set-Aside (WCMSA) Arrangement Reference Guide provides authority by which CMS will now recognize and defer to a Workers'...more

HHS Enjoined from Enforcing Self-Disallowance Regulation

On August 6th, the U.S. District Court for the District of Columbia enjoined HHS (along with the PRRB and CMS’s Medicare contractors) from applying HHS’s “self-disallowance” regulation to any appeals filed on the basis of an...more

No Harm, No Foul – Appellate Court Finds No CMIA Claim Without Actual Injury

California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”), provides that an individual may recover $1,000 nominal damages (plus actual damages if any) based on the negligent release of...more

Finally, Some Good News for Halifax–And All Other–Hospitals

It’s been a long time since Orlando’s Halifax Hospital got any good news from the federal court hearing the whistleblower case brought by employee Elin Baklid-Kunz. Earlier this year the hospital had to agree to an $85...more

Even in Privacy Cases, Risk of Injury Does not Always Equal Injury

It’s an ancient conundrum; if a tree falls in the forest, and no one is there to hear it, does it make a sound? Privacy litigation may well offer the closest jurisprudential equivalent; if data is stolen, but no one does...more

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more

District Court Applies FCA's First-to-File Rule to Determine Relator's Entitlement to Settlement Proceeds

On June 23, 2014, a U.S. District Court in Pennsylvania held that the first relator to file a qui tam complaint under the FCA is the only relator eligible to recover a portion of the settlement, notwithstanding the existence...more

District Court Grants in Part, Denies in Part Halifax Hospital's Motion for Summary Judgment on Relator's Non-Intervened FCA...

On July 1, 2014, a United States District Court in the Middle District of Florida granted in part, denied in part summary judgment in favor of Halifax Hospital Medical Center in connection with the non-intervened claims...more

California Court Limits Liability for Loss of Certain Patient Information under CMIA

California appellate courts are clarifying potential liability under California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”) of health care providers, health plans, pharmaceutical...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Halifax Health Gets In More Hot Water

You probably didn’t think Florida’s Halifax Health could make its situation any worse. After all, only two months ago Halifax agreed to pay $85 million to settle just the first half of a Medicare fraud case. That still...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

First Circuit Affirms Dismissal of FCA Complaint Based on First-to-File Bar

The First Circuit recently affirmed the dismissal of United States ex rel. Wilson v. Bristol-Myers Squibb, Inc. under the False Claims Act’s (“FCA”) “first-to-file” provision, which prohibits any person “other than the...more

Settlement Agreement Silent On "Costs" Leads To Prevailing Party Award

In deSaulles v. Community Hospital of the Monterey Peninsula, 2014 DJDAR 5571 (2014), the California Court of Appeal for the Sixth Appellate District decided that a prevailing party was entitled to costs, despite the fact...more

AHA Challenges to the Two-Midnight Rule - Preserve Your Hospital's Right to Challenge

The American Hospital Association (AHA), along with several state and regional hospital associations and several hospitals, recently filed two lawsuits challenging CMS’s two-midnight rule and related policies....more

Florida Supreme Court Strikes Down Wrongful Death Non-Economic Damages Cap for Med Mal Cases

On March 13, 2014, the Florida Supreme Court, in a 5-2 ruling, issued its long-awaited opinion following review of the Eleventh Circuit Court of Appeal’s decision in Estate of McCall v. United States, 642 F.3d 944 (11th Cir....more

HIPAA Complaint Seeks Class Action Status

A complaint filed in the Superior Court of California on March 14, 2014, requested certification as a class action and sought a wide variety of damages arising from a breach of personal information. Doe vs. Sutherland Health...more

Religious Freedom, Contraceptive Services, and The ACA: The Dilemma of the Self-Certification Provision

On February 21, 2014, the Seventh Circuit Court of Appeals, in a 2-to-1 decision, denied a preliminary injunction enjoining the federal government from enforcing the self-certification provisions of the Affordable Care Act...more

Rational Basis Review Is Not Empirical Basis Review: Fifth Circuit Criticizes the Seventh Circuit's Decision in Van Hollen

Late last year the Seventh Circuit issued its decision in Planned Parenthood of Wisconsin, Inc. v. Van Hollen, No. 13-2726 (7th Cir. Dec. 20, 2013), a constitutional challenge to a new Wisconsin law (known as Act 37) that...more

No Harm, Still Foul? Florida Court Approves Data-Breach Class Action Settlement

Data-breach class action suits may have just gained significant traction. On Feb. 28, 2014, the U.S. District Court for the Southern District of Florida approved a first of its kind class action data breach settlement that...more

Florida Hospital to Settle Stark Law Case for $85 Million: Tentative settlement between Halifax Hospital Medical Center and United...

The Department of Justice and Florida’s Halifax Hospital Medical Center have reached a tentative $85 million settlement in a case alleging violations of the federal physician self-referral law (commonly known as the “Stark...more

Shaking Down the Thunder from the Sky: Notre Dame’s Challenge to the Contraception Mandate

The Supreme Court will inevitably decide to what extent the Religious Freedom Restoration Act protects religiously affiliated employers from providing insurance coverage for contraceptive services, as is generally required...more

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