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The Courts

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.

Thursday, 19 January 2017

A controversial FDA memo released Wednesday (Jan. 18) defending the agency's oversight of off-label communication and raising concerns over the public health impact of such communication could be used as a tactic to stall potential future litigation against the agency, according to one key attorney.

Thursday, 19 January 2017

Industry got a long-sought nod that it can disseminate health care economic information (HCEI) on labeled and off-label uses to payers and health care professionals in certain cases if the data is based on competent and reliable scientific evidence thanks to draft FDA guidance released Wednesday (Jan. 18).

Thursday, 19 January 2017

Academy of Managed Care Pharmacy (AMCP) is drafting legislative language to share with the incoming administration that would allow for dissemination of biopharmaceutical clinical and economic information with formularies and other population health decision makers about 12 to 18 months before FDA approval.

Friday, 13 January 2017

A federal judge in Texas on Thursday (Jan. 12) granted dialysis stakeholders a temporary restraining order blocking HHS from implementing an interim final rule that called for dialysis facilities to get issuer approval before helping patients with premiums.

Friday, 13 January 2017

The U.S. Supreme Court will hear a closely watched biosimilars court case that will determine whether the 180-day marketing notification in the biosimilar pathway is only effective after FDA licensure, and whether an applicant is required to provide the reference product sponsor its application and related manufacturing information.

Wednesday, 11 January 2017

Davita CEO Ken Thiry told Inside Health Policy that the company has asked Congress to overturn CMS' interim final rule requiring dialysis facilities' get issuer approval before helping a patient with premium assistance, but said the rule is unlikely to make the short list of measures the GOP will try to ax though the Congressional Review Act.

Monday, 09 January 2017

Major dialysis providers and a group representing 30,000 patients is asking a federal district court in Texas to block CMS from implementing an interim final rule set to go into effect Friday (Jan. 13) that requires insurers to sign off before a third party can help patients pay premiums.

Wednesday, 21 December 2016

HHS is asking a federal court to reconsider its order that the department reduce the Medicare appeals backlog at the Administrative Law Judge level every year and eliminate it by 2021, saying the mandate would compromise the Medicare trust fund by forcing CMS to pay claims that may have been appropriately denied just to empty the appeals queue.

Tuesday, 20 December 2016

Two recipients of the ACA's cost-sharing reduction payments have filed a motion to intervene in House GOP's case against HHS out of concern the incoming president might not defend the Obama administration’s position in support of the payments, which could leave close to 6 million Americans unable to afford coverage.

Monday, 12 December 2016

The U.S. Supreme Court declined Monday (Dec. 12) to hear Amgen v. Apotex, a case that if taken up would have determined whether a lower court erred in requiring a biosimilar maker to give 180 days notice post FDA approval before launching a product, even when the company engages in the patent-exchange process of the Biologics Price Competition and Innovation Act, commonly known as the patent-dance process.

Monday, 12 December 2016

The Justice Department's recent $2.2 million settlement with dietary supplement retail giant GNC Holdings Inc. should send a “wake-up call” to the industry not to engage in illegal activity, DOJ told Inside Health Policy.

Wednesday, 07 December 2016

The acting U.S. solicitor general urged the U.S. Supreme Court Wednesday (Dec. 7) to take up the Sandoz v. Amgen case, and Amgen's cross-petition, that could drive key policies in the biosimilars law's patent dispute process.

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