Administrative Agency Civil Procedure Health

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

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

Also In The News - Health Headlines - March 2015 #2

Committee on Energy and Commerce Subcommittee on Health Hearing Regarding 340B Drug Pricing Program – On Thursday, March 5, 2015, the Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), is holding a hearing titled...more

CMS Publishes Final Rule Establishing Appeal Process for Applicable Plans in Medicare Secondary Payer Cases

On February 27, 2015, CMS published a final rule, effective April 28, 2015, to establish a formal, multilevel administrative appeals process for applicable plans against which Medicare Secondary Payer (MSP) recovery demands...more

Narrowing Of FCA Public Disclosure Bar Continues

On Feb. 25, 2015, the Sixth Circuit became the latest federal court of appeals to weigh in on the scope of the False Claims Act’s public disclosure bar in its decision in United States ex rel. Whipple v. Chattanooga-Hamilton...more

High Court Sides with DOL, Holding that Agencies May Flip-Flop on Regulatory Interpretations Without Engaging in...

In June, we wrote that the U.S. Supreme Court agreed to address whether a federal agency (in this case, the Department of Labor) must engage in formal notice-and-comment rulemaking in order to significantly alter its...more

The FCA and the Ever-Narrowing Public Disclosure Bar

On February 25, 2015, the Sixth Circuit became the latest federal court of appeals to weigh in on the scope of the False Claims Act’s (FCA) public disclosure bar in its decision in United States ex rel. Whipple v....more

Supreme Court Ruling's Implications for Healthcare Professions

The U.S. Supreme Court ruled that a state professional board controlled by active market participants must be supervised by a state to enjoy protection from federal antitrust laws....more

Supreme Court Denies Antitrust Shield for NC Dental Board

On Wednesday, February 25, 2015, the Supreme Court released a 6-3 decision in North Carolina Board of Dental Examiners v. Federal Trade Commission, a case with potentially broad implications for regulation by dental and...more

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