Login

Forgot password?
Sign up today and your first download is free.
REGISTER

The Courts

January 23, 2014 | Daily News

A bicameral group of lawmakers -- including top Republicans on key committees and one of the architects of the generic drug law -- say FDA's proposal that generic drug makers unilaterally update their labels with new safety information conflicts with statutory requirements that Congress has declined to change in recent decades.

January 16, 2014 | Daily News

The top priority for the generic drug industry in 2014 will be combating a new regulation aimed at requiring generic drugmakers to make labeling changes to reflect new safety information -- a shift from the current FDA regulatory paradigm that would be "draconian," according to the generic drug lobby's top official, who pledged broad outreach on the matter extending to the White House.

January 07, 2014 | Daily News

Triclosan in toothpaste could be just as harmful if not more so than in hand washes, the Natural Resources Defense Council argues in filing a recent lawsuit that comes on the heels of FDA action on antibacterial hand washes.

December 26, 2013 | Daily News

A recent government filing countering application of the First Amendment in a false claims case involving off-label promotion shows that the government is trying to limit a high-profile off-label ruling to cases brought under the Food, Drug and Cosmetic Act, industry attorneys said.

December 18, 2013 | Daily News

The Supreme Court Monday (Dec. 16) denied cert in U.S. v. W. Scott Harkonen, a case in which a lower court upheld a CEO's fraud conviction based on a press release touting clinical trial results.

November 27, 2013 | Daily News

As the Supreme Court agreed Tuesday (Nov. 26) to take on the highly controversial issue of the ACA's contraceptive coverage requirements, the Obama administration joined by women's groups and some health care providers urged the high court to resist letting employers dictate whether their female employees should be able to access such coverage.

November 26, 2013 | Daily News

Home health providers are planning a “March on the Capitol” to protest CMS' cuts to home health pay in the 2014 final pay rule and say that, if necessary, they will work with seniors' advocates to take the agency to court.

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.

Pages