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The Courts

November 25, 2013 | Daily News

Top FDA officials attribute advances in personalized medicine, including the agency's first authorization of gene sequencers, to regulatory science and a key Supreme Court ruling earlier this year.

November 21, 2013 | Daily News

A federal district court last week made it clear that a company developing a biosimilar can't shoot down an innovator's patent without first filing a formal biosimilar application with FDA and engaging in the subsequent “patent dance” spelled out in the health reform law's biosimilar provision.

November 15, 2013 | Daily News

Recent oral arguments in a high-profile medical device patent case signal the Supreme Court may reverse a federal circuit decision that shifted the burden of proof in declaratory judgments of non-infringement to the licensee of a patent, several attorneys following the case said.

September 16, 2013 |

The Treasury Department on Friday (Sept. 13) told Sen. Orrin Hatch (R-UT) that the ACA's premium tax credits are not available to workers enrolled in multi-employer plans because the workers are already covered by employer-sponsored insurance that receives a tax exclusion, a final decision handed down following a controversial, months-long effort by unions for multi-employer plan enrollees to be eligible for those subsidies.

September 13, 2013 | Inside CMS

The Senate Finance and House Ways & Means committees are expected to release around the end of the month similar draft bills to replace the Sustainable Growth Rate formula that do not include offsets for the cost of the bills, provider lobbyists say. But lobbyists don't expect Congress to agree on an SGR bill by the latter half of October when the country is expected to hit its debt limit so they hope that a large legislative vehicle will emerge in December to which Medicare physician payment reform could be attached.

September 12, 2013 | Inside CMS

As lawmakers seek ways to pay for fixing the Medicare physician-pay formula, CMS actuaries estimate that a two-year-old legislative proposal by Sen. Tom Coburn (R-OK) and former Sen. Joe Lieberman (D-CT) would reduce Medicare spending by $536 billion over a decade. The legislative proposal includes a new benefit structure with a uniform deductible and a cap on out-of-pocket spending, a higher eligibility age, limits on Medigap coverage, higher premiums, home health pay cuts and reductions to hospital bad debt payments.

September 12, 2013 | Health Reform Insider

(CNN) -- By nearly all accounts, 12-year-old Kali Hardig should not be alive. During a swim at a water park in July, she contracted parasitic meningitis, a rare infection caused by brain-eating amoebas that has a survival rate less than 1%.

September 11, 2013 | Health Reform Insider

The top Republicans on the House Ways & Means and Senate Finance Committees on Tuesday (Sept. 10) questioned the legality of what they describe as a potential "carve-out" for union members that would allow multi-employer plan enrollees to receive ACA exchange subsidies. In a letter to Treasury Secretary Jack Lew, the lawmakers criticized several groups' efforts, including many prominent unions, to get the administration to designate multi-employer plans as qualified health plans (QHPs), which would allow enrollees to be eligible for the subsidies.

December 03, 2012 | Daily News

The Supreme Court will hear two key cases related to the biotechnology and generic drug industries, with the high court deciding Friday (Nov. 30) to review Association for Molecular Pathology v. Myriad Genetics, a case on gene patenting, and Mutual Pharmaceutical Co. v. Bartlett, a generic drug preemption case.

July 27, 2012 | Daily News

Wisconsin's top health official says he expects there to be litigation if HHS doesn't budge on the controversial Medicaid maintenance of effort requirements, telling Inside Health Policy that attorneys in his state disagree with a recent finding by the Congressional Research Service and signals from HHS that the MOE requirements remain intact despite the high court's ruling that states can opt out of the health law's Medicaid expansion.

July 26, 2012 | Daily News

HHS Secretary Kathleen Sebelius met privately with key hospital groups earlier this week and urged them to convince states to move ahead with the reform law's Medicaid expansion as not doing so would be detrimental to hospitals, but the administration didn't reveal whether the law's hospital payment cuts would still kick in for states that do not expand Medicaid, a hospital lobbyist tells Inside Health Policy.

July 24, 2012 | Daily News

The Congressional Budget Office in its updated cost projections for the health reform law's coverage expansion appears to assume that HHS will let states expand Medicaid below 138 percent of the federal poverty level and still qualify for the law's higher match rate, Washington insiders tell Inside Health Policy, broaching a question that state Medicaid directors and many governors have posed to the administration but one which HHS has not officially answered.

July 23, 2012 | Daily News

Heads of several hospital groups met with HHS Secretary Kathleen Sebelius on Monday (July 23) to discuss Medicaid expansion issues that have emerged as a result of the Supreme Court's ruling, including “the connection between coverage and payment reductions,” according to the American Hospital Association.

July 19, 2012 | Daily News

Key GOP lawmakers have asked HHS Secretary Kathleen Sebelius to provide by the end of the month legislative and policy details on the Medicaid “blended rate” proposal included in the president's fiscal 2013 budget.

July 16, 2012 | Daily News

Republican Governors Association Chair Bob McDonnell (VA) told Inside Health Policy that he and his colleagues were not pleased with CMS' two-page response to the group's detailed list of 30 questions about how the Supreme Court's health law ruling affects health insurance exchanges and Medicaid expansion, adding that the GOP governors will be sending another letter soon, likely this week.

July 13, 2012 | Daily News

The National Association of Public Hospitals and Health Systems (NAPH) worries that up to 30 states could potentially opt-out of the Medicaid expansion, leaving millions uninsured and creating a untenable situation for public hospitals that would still be subject to lower Disproportionate Share Hospital payments.

July 13, 2012 | Daily News

CMS Acting Administrator Marilyn Tavenner says there is no deadline for a state to tell CMS if it plans to expand Medicaid, according to a July 13 letter to Republican Governors Association Chairman Bob McDonnell (VA) that was sent in response to a slew of questions GOP governors sent CMS earlier this week.

July 13, 2012 | Daily News

Washington insiders say the Supreme Court's Medicaid decision could be a neutral or even a plus for the pharmaceutical industry, although the full effect will not be known until it becomes clear how many states will opt out of the health law's Medicaid expansion.

July 13, 2012 | Daily News

Sen. John Rockefeller (D-WV) appealed to the nation's largest seniors group on Thursday to start educating its members about the benefits of Medicaid as states struggle with how to respond to the Supreme Court's decision to essentially make Medicaid expansion voluntary.

July 11, 2012 | Daily News

Despite the focus on governors' positions on the reform law's now voluntary Medicaid expansion, state legislatures may have the chance to approve or deny the expansions and some believe that state Republican governors seeking attention on the national stage may run up against state lawmakers who are focused locally on the needs of those in their districts.

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