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The Courts

March 23, 2016 | Daily News

U.S. Supreme Court justices on Wednesday (March 23) mulled whether allowing contraceptive-only plans onto the exchanges is a viable way to preserve women's access to birth control, if religious nonprofits are able to avoid the Affordable Care Act's so-called “contraception mandate” as a result of Zubik v. Burwell.

March 16, 2016 | Daily News

Health care advocates on Wednesday pointed to the Supreme Court's narrow rulings in recent high-profile health care cases, as well as the one coming next week, in urging Republican senators to back away from their earlier statements and quickly consider President Barack Obama's nominee Merrick Garland as the next U.S. Supreme Court justice.

March 14, 2016 | Daily News

The Center for Medicare Advocacy and HHS have agreed on a proposed settlement of a class action lawsuit over the backlog at the third level of Medicare appeals where HHS would take steps to make sure beneficiary claims are identified and handled before others, and the agency would publish more information on beneficiary wait times for Administrative Law Judges' decisions, among other steps.

March 08, 2016 | Daily News

Amarin Pharma Inc. and FDA have settled what is viewed by drug industry lawyers as one of the biggest First Amendment cases relating to off-label marketing speech, agreeing the drug maker can promote its drug Vascepa off-label to health care professionals as long as the statements are truthful and not misleading.

February 26, 2016 | Daily News

Oregon's failed co-op Health Republic Insurance on Wednesday (Feb. 24) became the first to definitively answer the question many have had on their minds since last summer: Will anyone sue the Obama administration over the unexpectedly low risk corridor payments paid to insurers?

February 18, 2016 | Daily News

Sandoz has asked the Supreme Court to take up its high-profile case against Amgen over the biosimilar approval pathway's commercial marketing notification requirements.

February 18, 2016 | Daily News

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

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.