Administrative Agency Civil Procedure Health

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News & Analysis as of

Responding to Subpoenas and Other Requests for Personal Health Information: Take Them at Face Value

Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more

Change to FLSA Companionship Exemption Extends Minimum Wage and Overtime Protections to Home Health Care Aides

After almost fourteen months of legal challenges, the U.S. Department of Labor has emerged victorious in its attempt to modify the FLSA’s companionship exemption. On August 21, the U.S. Court of Appeals for the D.C. Circuit...more

CMS's "At a Collection Agency" Bad Debt Policy - Confusion Continues

As we reported in previous Payment Matters articles, the United States District Court for the District of Columbia has issued inconsistent opinions regarding Medicare's policy not to allow bad debt when that bad debt is still...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

Be Careful What You Say: Allegations Of Worker Misconduct Might Be Defamation

Healthcare institutions have a moral and legal obligation to promote patient safety as an essential component of patient care. Supervisors and managers must be supportive of their staffs while remaining vigilant about the...more

When Is An Overpayment “Identified?” The Answer Is In

In a highly anticipated ruling in Kane ex rel United States, et al. v. Health First, Inc., et al., a New York federal judge has issued the first judicial interpretation of the sixty-day overpayment return provision in the...more

Third Circuit Invalidates HHS’ Medicare Wage Index Reclassification Rule

On July 23, 2015, the Third Circuit invalidated, as being contrary to the Medicare statute, the U.S. Department of Health and Human Services’ (HHS) Medicare wage index “reclassification rule,” 42 C.F.R. § 412.230(a)(5)(iii)....more

Stark Litigation: The Tuomey Saga Draws to a Close

In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more

Health Law Wire: Court Invalidates DOH Retroactive Clinic Rate Changes (6/15)

The Appellate Division Fourth Department recently invalidated DOH’s attempts to retroactively revise Diagnostic & Treatment Center (D&TC) rates and upheld statutory requirements for 30 day advance notice of capital rate...more

Written Reasons in Administrative Decisions

Fashoranti v. College of Physicians and Surgeons of Nova Scotia, 2015 NSCA 25, dismissing an appeal from the disciplinary committee’s finding that a physician committed unprofessional conduct. A physician was charged...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

D.C. District Court Formalizes Remand of Allina Case Regarding the Appropriate Treatment of Medicare Part C Patient Days for...

On May 18, 2015, the United States District Court for the District of Columbia ordered HHS to adjudicate the appropriate treatment of Medicare Part C patient days in determining disproportionate share hospital (DSH) payments....more

Partial Victory for Hospitals in Medicare Outlier Challenge

In a decision issued May 19, 2015, the United States Court of Appeals for District of Columbia Circuit handed hospitals a partial victory in their challenge to their Medicare outlier payments for 2004. District Hospital...more

D.C. Circuit Rules that Secretary Must More Adequately Explain Outlier Rulemaking

The D.C. Circuit Court of Appeals recently issued a partially favorable ruling for hospitals seeking additional outlier payments under the Medicare program. In District Hospital Partners v. Burwell, a three-judge panel held...more

Developments in Long-Term Care – Q1 2015

The following summary highlights key federal court cases and administrative decisions involving skilled nursing facility survey issues during the first quarter of 2015. Federal Court Cases - Fifth Circuit Upholds...more

Recent Court and Agency Actions Suggest Increased Antitrust Risk Over Disgorgement, Particularly in the Pharmaceutical Industry

Recent court and agency rulings highlight important takeaways involving disgorgement in antitrust proceedings. Companies, especially those in the pharmaceutical industry, increasingly should ensure they properly calibrate...more

Challenge to DSH Adjustment Estimates Barred by Statute

In a decision issued on March 31, the United States District Court for the District of Columbia dismissed a challenge by Florida Health Sciences Center, Inc., also known as Tampa General Hospital, to the calculation of its...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Developments in Judicial Deference of Administrative Agency Actions

In my post of April 2, Divided Supreme Court Restricts Provider Challenges to State Medicaid Rates, I wrote about the March 31st Supreme Court decision that providers may not sue in federal court over the adequacy of state...more

The Supreme Court Holds That Medicaid Providers Cannot Sue To Enforce Federal Reimbursement Rate Standards

On March 31, 2015, the U.S. Supreme Court issued its decision in Armstrong v. Exceptional Child Center, Inc., holding that Medicaid providers cannot sue to enforce reimbursement standards set forth in federal Medicaid law....more

Telemedicine Providers Need to Keep Up with State Laws

Tech-savvy health care providers and tech-savvy patients in California can be grateful for California’s policies regarding telehealth practices. Consider the turmoil in Texas: telehealth practitioners who want to treat...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

Open Season on Provider-controlled Licensing Boards

In a closely followed decision with significant consequences for state licensing boards and their members, the Supreme Court in North Carolina State Board of Dental Examiners v. Federal Trade Commission, 135 S. Ct. 1101...more

Supreme Court Blocks Provider Challenges to Medicaid Program

On March 31, 2015, the Supreme Court issued the first of several expected decisions that will impact the healthcare industry this year, ruling that Medicaid providers have no constitutional or statutory right to challenge a...more

The Pitfalls of Settling Qui Tam Lawsuits

In a recent federal court case, the federal government and the State of California successfully enforced an oral settlement agreement of a qui tam lawsuit against a health care provider. United States v. North East Medical...more

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