OBAMACARE CREDITS COULD TRIGGER SURPRISE TAX BILLS

OBAMACARE CREDITS COULD TRIGGER SURPRISE TAX BILLS-associatedpress: President Barack Obama's new health care law will offer subsidies to help people buy private health insurance on state-based exchanges, if they don't already get coverage through their employers. The subsidies are based on income. The lower your income, the bigger the subsidy.

Gain In Procedures From Newly Insured Under Health Reform Will Offset Device Tax, Analyst Says

Gain In Procedures From Newly Insured Under Health Reform Will Offset Device Tax, Analyst Says-graysheet: A Wells Fargo analysis on the expected increase in device utilization rates based on expanded insurance coverage due to provisions of the Affordable Care Act will offset the financial impacts of the 2.3 percent device excise tax.

A fiscal deal or fiscal crisis?

A fiscal deal or fiscal crisis?-politico: Now that Congress and the president have agreed to fund the government for the rest of this fiscal year — removing the threat of a government shutdown — Washington should use this opportunity to get past the crisis-driven fiscal policy of recent years and put the focus squarely where it belongs: on the long term.

CAN MASS MARKETING HEAL THE SPLITS ON 'OBAMACARE'?

CAN MASS MARKETING HEAL THE SPLITS ON 'OBAMACARE'?-associatedpress: With the nation still split over President Barack Obama's health care law, the administration has turned to the science of mass marketing for help in understanding the lives of uninsured people, hoping to craft winning pitches for a surprisingly varied group in society.

EU Parliament Considers More Stringent Medical Device Regulations

EU Parliament Considers More Stringent Medical Device Regulations-graysheet: Continuing the argument from the committee’s Feb. 26 meeting, Dagmar Roth-Behrendt of Germany, the rapporteur of the committee, advocated that a more extensive pre-market approval process should be created for Europe. “I want to have a centralized pre-market authorization for the highest class [of medical devices],” she said in her opening remarks. (See "Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms" — "The Gray Sheet," Mar. 11, 2013.) “Doctors insist on pre-market authorization,” she said later.

FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says

FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says-graysheet: The two agencies formally launched a pilot program for parallel review in 2011, opening up a collaborative effort that allows CMS to begin considering a national Medicare coverage policy for select new technologies as FDA is reviewing the safety and efficacy of a device for regulatory approval. (See "Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot" — "The Gray Sheet," Oct. 17, 2011.) The goal is to speed up the time it takes a manufacturer to move from product development to securing Medicare reimbursement, a high priority for any device firm looking to gain a marketing edge.

Lawsuit over health care tax could kill ‘Obamacare’

Lawsuit over health care tax could kill ‘Obamacare’-washingtontimes: “Obamacare” looks increasingly inevitable, but one lawsuit making its way through the court system could pull the plug on the sweeping federal health care law. A challenge filed by the Pacific Legal Foundation contends that the Affordable Care Act is unconstitutional because the bill originated in the Senate, not the House. Under the Origination Clause of the Constitution, all bills raising revenue must begin in the House.