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The Courts

March 03, 2015 | Daily News

A Republican House aide tells Inside Health Policy that House Republicans' fix to a potential Supreme Court ruling to end premium subsidies for those insured by the federal exchange would not cap employer-sponsored subsidies to offset the costs of the GOP plan to offer advance-able, refundable tax credits, but instead would pay for the credits with “savings from the eliminated subsidies.”

March 03, 2015 | Daily News

Congressional Democrats pitched a last-minute defense of the Affordable Care Act Tuesday (March 3) as President Obama's signature law again heads to the U.S. Supreme Court, this time for oral arguments in King v. Burwell, while at the same time key members of the GOP raced to put forth viable solutions should the court rule that subsidies cannot flow through the federal exchanges -- a result that the GOP is hoping for, but which could cause significant political fallout.

March 03, 2015 | Daily News

Hospitals and the National Rural Health Association backed the Health Resources and Services Administration's interpretation of orphan drug discounts in the 340B program in court, telling the federal district court judge in recently submitted briefs that striking down HRSA's latest 340B orphan drug rule could be devastating for rural hospitals.

February 27, 2015 | Daily News

Jay Angoff, who was the administration’s first chief of the ACA implementation office, tells Inside Health Policy that while during his tenure many HHS officials clearly wanted states to establish their own exchanges, there was never an indication that subsidies would not be available through the federal exchange.

February 26, 2015 | Daily News

HHS Secretary Sylvia Burwell denied knowledge of an alleged document outlining post-King contingency plans, after a key GOP lawmaker told her Thursday morning that a department official informed him of a hundred-or-so page report circulating among top HHS officials that details actions the Obama administration could take if the U.S. Supreme Court rules against it in King v. Burwell.

February 25, 2015 | Daily News

Senate Finance Chair Orrin Hatch (R-UT) on Wednesday asked CMS Administrator Marilyn Tavenner to explain why the agency put a clause in its contracts with Healthcare.gov issuers last fall giving them an option to pull out if federal subsidies come to an end, suggesting the move contradicts HHS' assertion that it has no back-up plan should the U.S. Supreme Court rule that subsidies can't flow through federally facilitated exchanges.

February 24, 2015 | Daily News

HHS should take proactive steps to prepare for the potential fallout of a King loss by allowing qualified health plan (QHP) issuers to either submit two rate filings during the initial submission window -- one with assumptions based on subsidies and one without -- or to revise their rates after the May 15 deadline, the American Academy of Actuaries says in a letter sent to HHS Tuesday (Feb. 24).

February 18, 2015 | Daily News

Senate Finance Republicans are the latest to press a mum administration on how it would deal with the fallout if the Supreme Court rules that subsidies cannot flow through exchanges established by the federal government, coming as GOP lawmakers and stakeholders increasingly focus on potential legislative and administrative fixes should such a ruling surface.

January 29, 2015 | Daily News

A federal judge, in a D.C. Circuit Court memorandum opinion unsealed last week, ruled that the Hatch-Waxman Act gives drug makers the right to choose which listed drugs they reference in 505(b)(2) applications but that FDA can look at data on similar drugs without requiring the applicants to reference relevant patents for those drugs.

January 28, 2015 | Daily News

House Energy and Commerce Republicans on Wednesday (Jan. 28) asked HHS to hand over any communications and documents related to potential contingency plans should the Supreme Court rule against the administration in King v. Burwell, a decision that would eliminate subsidies for those who enrolled via Healthcare.gov.

January 28, 2015 | Daily News

Two current and former congressmen said Wednesday (Jan. 28) that a U.S. Supreme Court ruling to make subsidies unavailable through the federal health insurance exchange in King v. Burwell would go against the way they wrote the law and their intent to provide health insurance to all Americans.

January 27, 2015 | Daily News

Since the Affordable Care Act's passage, opponents have turned to the court system to challenge the legality of its mandates, clauses, subsidies and effects on congressional authority, with many lawsuits pending in addition to the high-profile Supreme Court suit on whether subsidies are available in federally facilitated exchanges.

January 26, 2015 | Daily News

The GOP-led Congress would likely act on a short-term legislative fix to the health care law that would allow federal subsidies to continue flowing through the federal exchanges up to a set date, albeit in exchange for certain concessions from Democrats in the event that the Supreme Court rules against the administration in King v. Burwell, several sources are suggesting.

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.