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The Courts

February 17, 2016 | Daily News

The Congressional Budget Office says a bipartisan Senate Finance Committee plan to revamp the Medicare appeals process would increase spending by about $1.7 billion over 10 years, coming as a federal appeals court says the bill's progress could help gauge whether Congress and HHS are serious about resolving the backlog at the third level of Medicare appeals and in turn whether the judicial branch needs to step in.

February 16, 2016 | Daily News

U.S. Supreme Court Justice Antonin Scalia's death is not expected to derail the high court's progress next month on a consolidation of seven cases brought by religious nonprofits challenging the Affordable Care Act's contraceptive mandate, legal experts said Tuesday.

February 10, 2016 | Daily News

A federal appeals court revived the American Hospital Association's lawsuit over the backlog at the third level of the Medicare appeals process after a lower court dismissed it and said that HHS and Congress, and not the courts, needed to address the issue.

February 01, 2016 | Daily News

UnitedHealthcare and its plans sued CMS over a Medicare Advantage rule that requires plans to report and return risk adjustment overpayments for diagnoses that aren't backed up by a beneficiary's medical record.

January 22, 2016 | Daily News

Internal disagreement within FDA, as well as between the agency and HHS, regarding what policy path to take on off-label promotion of drugs has stalled several long-promised draft guidances, as well as stifled the agency’s enforcement against violators, several sources speaking on the condition of anonymity tell Inside Health Policy.

January 22, 2016 | Daily News

The FDA drug center's 2016 guidance agenda, unveiled Friday (Jan. 22), includes several long-promised documents related to the off-label promotion of approved drugs.

January 08, 2016 | Daily News

A lawyer for the firm that represented Pacira Pharmaceuticals in its recently settled case against FDA's policies on promotion and advertising said the settlement along with other recent court decisions is part of a trend showing companies can challenge the agency's policies in this area and win and leaving FDA gun-shy about litigating such cases.

January 04, 2016 | Daily News

The U.S. Supreme Court has given Sandoz until Feb. 16 to file a petition appealing a decision from the Federal Circuit appeals court that ruled the patent exchange provisions in the biosimilar pathway are optional but the 180-day commercial marketing notification is mandatory and only effective after approval.

January 04, 2016 | Daily News

As plaintiff bars across the country capitalize on uncertainty in the law and one state prepares to implement a landmark piece of legislation on the issue, FDA is extending the deadline for comments on the use of the term “natural” on food labels to May 10, 2016.

December 31, 2015 | Daily News

The cost of liability continues to increase in the long-term care sector, and tort reform has led to mixed results in terms of loss rates, according to a recent report from the American Health Care Association (AHCA) and Aon Global Risk Consulting.

December 30, 2015 | Daily News

The Union of Concerned Scientists praised FDA's recently issued social media policy for drawing what the group views as an "important distinction" between agency employees' official and personal use of social media, and for letting FDA scientists include their agency titles in their personal use of such accounts.

December 16, 2015 | Daily News

Amarin Pharma Inc. and FDA asked a federal judge Wednesday (Dec. 16) to give them more time to reach a settlement in the off-label promotion case filed by the drug maker against the agency.

December 15, 2015 | Daily News

FDA announced Monday (Dec. 14) it has formally rescinded a warning letter to Pacira Pharmaceuticals, Inc. and made changes to the company's post-surgical analgesic Exparel label confirming its broad indication as part of a formal settlement with the drug maker of a highly watched lawsuit prompted by the agency's allegations that Pacira was marketing its product for off-label uses.

December 14, 2015 | Daily News

The brand-name drug lobby comes out strong in defense of Pacira Pharmaceuticals in a closely watched lawsuit challenging FDA's off-label policies, contending in an amicus brief that the agency is attempting to narrow the indication of an approved drug without going through the required regulatory process.

December 14, 2015 | Daily News

The federal district court in southern Florida ordered Apotex to provide Amgen with a 180-day notice of the first commercial marketing of its pegfilgrastim biosimilar if the product is approved, saying the notice is mandatory for all applicants regardless of whether they participated in the patent exchange provisions of the biosimilar pathway.

December 04, 2015 | Daily News

A coalition of drug and medical device makers has weighed in on the side of Pacira Pharmaceuticals in a high-profile lawsuit challenging FDA's off-label policies, arguing in an amicus brief that the agency's vague regulatory and enforcement policies on off-label communication chills constitutionally protected speech.

November 18, 2015 | Daily News

The White House Office of Management and Budget recently began reviewing a CMS notice on inpatient hospital cuts that the agency says is a response to the American Hospital Association's lawsuit over reimbursement cuts associated with the two-midnight hospital admissions policy.

November 11, 2015 | Daily News

Facing pressure from Congress and a series of competing citizen petitions, FDA is seeking public input on whether it should define the term “natural” for use on food product labels, and, if so, how to do so.

November 06, 2015 | Daily News

The Supreme Court on Friday (Nov. 6) agreed to review a consolidated version of seven similar cases from across the country, including Little Sisters of the Poor V. Burwell, that claim the administration’s accommodation allowing certain institutions an exemption from the Affordable Care Act requirements to provide contraceptives at no cost to the enrollees is overly burdensome and violates religious freedom.

November 06, 2015 | Daily News

Industry attorneys expect either Amgen or Sandoz to appeal the fractured Federal Circuit's decision concerning the biosimilar pathway's patent and marketing requirements to the Supreme Court, with one attorney saying there is "simply too much at stake here for the budding biosimilar industry."

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