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The Courts

January 23, 2015 | Daily News

The Supreme Court handed Teva Pharmaceuticals a major win this week by ordering a federal appeals court to revisit its decision to shoot down a subset of Teva's patents for a complex multiple sclerosis drug, demanding the U.S. Court of Appeals for the Federal Circuit consider information generated by the district court unless it is found to be in "clear error."

January 22, 2015 | Daily News

The Supreme Court's decision this week not to take up a lower court's ruling that a generic drug company should have immediately updated its product label to include new safety data puts the spotlight back on FDA, which is already facing intense pressure from generic drug makers not to finalize a proposed rule that would impose similar labeling requirements.

January 21, 2015 | Daily News

Chief Justice John Roberts expressed concern during U.S. Supreme Court arguments Tuesday (Jan. 20) that if providers could sue for better Medicaid reimbursement, federal courts could end up overly involved in states' budgets, which he said would be “a prescription for budget-busting across the board.”

January 06, 2015 | Daily News

A federal district court on Tuesday (Jan. 6) cleared the way for the National Association for Home Care and Hospice to move forward with its lawsuit over the Affordable Care Act's face-to-face requirements, ruling against CMS' motion to dismiss the case.

December 29, 2014 | Daily News

FDA is standing firm on its policy that designated drugs sharing the same indications as previously approved drugs must show they are clinically superior in order to get orphan drug exclusivity, despite a federal DC district court ruling that forced the agency to provide exclusivity to a drug it had previously deemed not superior to an identical drug on the market.

December 23, 2014 | Daily News

With oral arguments in the King v. Burwell lawsuit now set for early March, some policymakers and advisers are still fiercely debating whether the U.S. Supreme Court could rule that the federally facilitated marketplace's premium tax credits are retroactively illegal and require subsidy recipients to reimburse the cost of those credits

December 23, 2014 | Daily News

The Center for Medicare Advocacy, along with Vermont Legal Aid, sued HHS Friday (Dec. 19) over alleged Medicare denials of home health services for beneficiaries who appeals judges have previously recognized as homebound, but Medicare contractors say are not.

December 19, 2014 | Daily News

The federal DC District Court dismissed the American Hospital Association's lawsuit to compel HHS to turn around Medicare appeals decisions on time -- within 90 days at the third level of appeals -- and ruled that Congress and HHS should solve the problem, not the courts.

December 18, 2014 | Daily News

Senate GOP leaders are asking HHS and IRS to inform all federal exchange enrollees and visitors to healthcare.gov that their ACA subsidies could be taken away if the Supreme Court rules against the administration in King v. Burwell.

December 18, 2014 | Daily News

Dialysis patients are challenging CMS’ dialysis star ratings program, using a law called the Data Quality Act, on the grounds the ratings program confuses patients, disadvantages facilities in states with sicker residents and was created without public input.

December 16, 2014 | Daily News

Outgoing House Energy and Commerce Ranking Democrat Henry Waxman (CA) on Tuesday (Dec. 16) released a report finding breaking down the state-by-state impact if the administration ends up losing the high-profile Supreme Court case King v. Burwell that will determine whether the IRS overstepped in saying ACA subsidies are available for health insurance bought through the federal exchange.

October 23, 2014 | Daily News

Monetary restrictions on settlements that result from government legal action against corporations could curb the rise in million-and billion-dollar settlements, according to a report from the U.S. Chamber of Commerce's Institute for Legal Reform, which poses several other possible reforms.

July 22, 2014 | Daily News

ACA supporters hope the U.S. Court of Appeals for the DC Circuit will quickly grant the Obama administration's upcoming request for an “en banc” review of Tuesday's Halbig v. Burwell decision that, if ultimately upheld, would deal a significant blow to the health law's promise of providing affordable health insurance, though attorneys note en banc petitions are rarely accepted.

July 02, 2014 | Daily News

Reps. Diana DeGette (D-CO) and Jerrold Nadler (D-NY) said Wednesday (July 2) they are working on a legislative response to the Supreme Court's Hobby Lobby ruling that will ensure employers cannot use the Religious Freedom Restoration Act to avoid covering employees' contraceptives.

June 30, 2014 | Daily News

HHS in the immediate aftermath of the Supreme Court's contraceptive coverage decision should extend the “accommodation” it granted for religious non-profit organizations to for-profit companies because it's the only realistic short-term solution to mitigate the ruling's consequences, the head of consumer group National Health Law Program tells Inside Health Policy.

June 30, 2014 | Daily News

The Supreme Court, in its decision Monday (June 30) scaling back the ACA's controversial contraception coverage mandate, suggests that HHS' existing “accommodation” letting some religiously affiliated non-profit institutions avoid directly providing contraception coverage may have actually hurt the government's case that Hobby Lobby still needed to comply with the ACA provision and did not deserve a similar exemption.

June 09, 2014 | Daily News

A Supreme Court ruling last week, when taken in concert with a string of recent high court patent decisions, has put personalized medicine between "a rock and a hard place," one patent attorney said.

June 05, 2014 | Daily News

The Center for Medicare Advocacy has filed a class action lawsuit against HHS over the first two levels of the Medicare appeals system, which the center alleges “rubber stamp” coverage denials at both the Redetermination and Reconsideration levels of appeals.

April 28, 2014 | Daily News

The Solicitor General's position in the case POM Wonderful LLC v. The Coca-Cola Company received some pushback from Supreme Court justices during oral arguments last week, with justices asking why the two statutes involved, the Food, Drug and Cosmetic Act (FDCA) and Lanham Act, could not be complementary.

April 18, 2014 | Daily News

The Solicitor General recently told the Supreme Court, in a case slated to be heard next week, that companies cannot bring false advertising cases when FDA explicitly regulates a product, although FDA laws do not broadly prevent them from doing so.

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