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The Courts

Friday, 28 April 2017

A federal appeals court upheld the D.C. District Court's decision to block the merger between Anthem and Cigna -- a move praised by the American Medical Association and the New York Attorney General.

Wednesday, 26 April 2017

During Wednesday (April 26)'s oral arguments in a highly watched U.S. Supreme Court case, a key government attorney shot down an idea from Supreme Court Associate Justice Stephen Breyer that FDA should weigh in through notice-and-comment rulemaking on how to interpret the biosimilar pathway before the court interprets the statute, given the complexity of the topic.

Tuesday, 25 April 2017

The U.S. Supreme Court will hear oral arguments Wednesday (April 26) in Amgen v. Sandoz -- the high court's first case dealing with the biosimilar pathway established by the Affordable Care Act and which stakeholders view as key to determining the rules of the road for innovator and biosimilar sponsors.

Tuesday, 18 April 2017

Health insurance officials who met with CMS Administrator Seema Verma Tuesday say they pushed the agency to address the industry's most immediate concern: the status of the ACA's cost-sharing reduction payments.

Thursday, 13 April 2017

FDA failed to follow its own rules when the agency notified the public of an Antimicrobial Drugs Advisory Committee meeting just six days before the meeting was to be held, and five days before the docket closed to public comment, consumer group Public Citizen alleges.

Tuesday, 04 April 2017

A group of Senate Democrats on Tuesday (April 4) urged Attorney General Jeff Sessions to continue the prior administration's appeal of a lower court's decision in the House GOP's lawsuit over the ACA's cost-sharing reductions, which the House does not intend to drop, and as the case proceeds fund the payments so that Americans can have predictability.

Monday, 03 April 2017

An administration official on Monday (April 3) told Inside Health Policy that the Trump administration will follow precedent and will fund the ACA's cost-sharing reductions subsidies as long the House suit over the payments is in litigation, providing one of the first indications of where the White House stands on the issue.

Friday, 31 March 2017

Democratic senators expressed concern during a four-day Judiciary Committee hearing that Supreme Court nominee Neil Gorsuch's opposition to courts deferring to the statutory interpretations of agencies under the so-called Chevron doctrine could be used to dismantle regulations, including those at FDA.

Thursday, 30 March 2017

House Speaker Paul Ryan (R-WI) said Thursday that the House has no plans to drop its lawsuit against the administration over the ACA's cost-sharing reduction payments, suggesting Republicans want to hang on to the lower court's ruling that the chamber has standing to sue the executive branch.

Wednesday, 29 March 2017

Republicans have been all over the map this week regarding whether they intend to fund the ACA's cost-sharing reduction payments, but two key lawmakers from the House and Senate said Wednesday (March 29) that they do intend to take action in order to prevent potential chaos.

Monday, 27 March 2017

Insurers owed money under the Affordable Care Act's risk corridor program in 2014 or 2015 have until May 12 to join a class action suit against the federal government certified by the U.S. Court of Claims, according to a notice from the court-appointed law firm.

Tuesday, 21 February 2017

The House and the Trump administration on Tuesday (Feb. 21) asked a federal court to further delay a high-profile case over the ACA’s cost-sharing reduction payments to allow time for the parties to reach a resolution, potentially through legislation.

Thursday, 09 February 2017

U.S. Court of Claims Judge Thomas Wheeler ruled Thursday (Feb. 9) that the government failed to abide by a promise made to issuers when it didn't provide ACA risk corridor payments and must pay Oregon-based Moda Health $214 million the company was owned for 2015 and 2015.

Wednesday, 08 February 2017

Environmentalists, labor unions and other pro-regulation advocates are suing over President Donald Trump's executive order (EO) that requires agencies to balance each new rule they issue by identifying two existing rules for repeal, saying the mandate violates Clean Air Act requirements for the Environmental Protection Act to issue air and climate regulations.

Monday, 06 February 2017

A federal district court laid out a plan for CMS to fix its Medicare improvement standard outreach following a four-year old settlement agreement under which the agency said it would halt a widespread, unofficial policy of cutting off coverage for certain services when beneficiaries stop improving.

Tuesday, 31 January 2017

President Donald Trump hopes to fill the Supreme Court vacancy with appellate court judge Neil Gorsuch, a law originalist who has been a fierce opponent of courts deferring to statutory interpretations of agencies under the so-called Chevron doctrine.

Friday, 27 January 2017

Over 30 disease advocacy groups wrote to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schemer (D-NY) Tuesday (Jan. 24) urging Congress to work with FDA to craft a regulatory framework for laboratory developed tests (LDTs).

Thursday, 26 January 2017

The U.S. Supreme Court has announced the scheduling for Amgen v. Sandoz and Amgen's related cross petition to determine the requirements of the Biologics Price Competition and Innovation Act 's so-called patent dance process.

Wednesday, 25 January 2017

A federal court in Texas Wednesday (Jan. 25) issued a preliminary injunction blocking HHS from implementing an interim final rule that would require dialysis facilities to get issuer approval prior to helping end-stage renal disease patients get charitable assistance to cover their premiums.

Monday, 23 January 2017

Federal D.C. district court judge John Bates ruled Monday (Jan. 23) to block a merger between Aetna and Humana, saying the Department of Justice had proved its case that the merger would unlawfully threaten competition and directly harm Medicare Advantage enrollees.