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Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...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

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 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...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

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

"2014-15 Supreme Court Highlights"

Approaching the midpoint of its 2014-15 term, the Supreme Court has added to its docket several cases with potentially wide-reaching implications for a range of important policy and business issues. The Court accepted for...more

Williams Mullen and Local Counsel, Bryan Davis, Win Declaratory Action Against HSD in New Mexico!!

For those of you who follow my blog, you know that the single state agency in New Mexico, Human Services Department (HSD), accused 15 behavioral health care providers, which made up 87% of the mental health care in NM, of...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Texas Appeals Court Invalidates Certain Medicaid Payment Hold Rules

Last week, a Texas appeals court invalidated three rules that permitted the Texas Health and Human Services Commission (HHSC) and the Texas OIG to impose a pre-notice payment hold against a Medicaid provider in certain...more

New Jersey Court Supports Peer Review Immunity for Hospital

On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and...more

Illinois Supreme Court Rejects Constitutional Challenge to Medical Licensing Amendments

Last month, a unanimous Illinois Supreme Court rejected assorted constitutional challenges to 2011 amendments to the Department of Professional Regulation Law governing medical licensing. In an opinion by Justice Burke, the...more

A (Second) Lawsuit Seeks to Compel Statutory Timeframe for Administrative Law Judge Review of Medicare Claims Appeals

On August 26th, the Center for Medicare Advocacy filed a nationwide class action lawsuit against the Secretary of Health and Human Services. The complaint alleges that, as implemented, the Medicare administrative review...more

North Carolina Dental Board Urges Reversal of FTC’s “Radical” Stance on State Action Immunity

North Carolina’s State Board of Dental Examiners has urged the U.S. Supreme Court to reject the Federal Trade Commission’s (FTC’s) “radical departure” from decades of established precedent that offers state actors immunity...more

Medicare Beneficiaries Sue HHS Over 489-Day Backlog in ALJ Appeals

The Center for Medicare Advocacy (CMA) filed a complaint last week on behalf of five Medicare beneficiaries in federal district Court in Connecticut requesting a court order requiring the Secretary of HHS to clear a massive...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

What Has Fahlen Wrought?

The California Supreme Court's decision in Fahlen v. Sutter Central Valley Hospitals has confirmed (not created) a sea change in the relations between hospitals and their medical staffs on the one hand, and physicians on such...more

Court Dismisses POD Lawsuit Against OIG

On February 5, 2014, a federal court dismissed a challenge to the U.S. Department of Health and Human Services’ Office of Inspector General’s (“OIG”) March 26, 2013 Special Fraud Alert (“2013 SFA”) on physician-owned...more

California Court Clarifies Controversial Questions About Medical Staff Peer Review Decisions and the Power of Hospital Boards

Two recent California Court of Appeal opinions decide issues of first impression in the medical staff peer review arena, helping to resolve questions that have long been uncertain and controversial. In the first of the two...more

Caso Lídia Teixeira x União (Senado)

Justiça derruba limite de gastos do Senado com assistência à saúde de viúva de ex-Senador

"No caso dos autos, como referido linhas retro, a Requerente é pessoa idosa, necessitada de constante acompanhamento médico-hospitalar e ambulatorial, em clínicas de tratamentos multidisciplinares e que, em vista de constar...more

The Best of Both Worlds: Applying Federal Commerce and State Police Powers To Reduce Prescription Drug Abuse

"The Best of Both Worlds: Applying Federal Commerce and State Police Powers To Reduce Prescription Drug Abuse," was published in the University of Maryland Law's Journal of Health Care Law & Policy Vol. 16. The article...more

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