Super Committee Pick Could Open Door to Grand Bargain, Sources Say - InsideHealthPolicy.com

Super Committee Pick Could Open Door to Grand Bargain, Sources Say - InsideHealthPolicy.com: The super committee's decision to tap Mark Prater, the deputy staff director and chief tax counsel for Senate Finance Republicans, as its staff director received rave reviews, although health sources differ on what the appointment says about the panel's priorities or chances of success. Some sources suggest the decision clearly means that the committee will make a serious attempt at tax and entitlement reform, and this could indicate a stronger likelihood of a “grand bargain.” Others warn not to read too much into the appointment, but stress that Prater is a well-respected longtime staffer with strong institutional knowledge of health care and tax policies.

Medtronic's CoreValve "a 2014 product" for U.S., looks good in clinical trials | European Society of Cardiology Congress 2011 | MassDevice - Medical Device Industry News

Medtronic's CoreValve "a 2014 product" for U.S., looks good in clinical trials European Society of Cardiology Congress 2011 MassDevice - Medical Device Industry News: Medtronic Inc. (NYSE:MDT) touted the latest results from studies of its CoreValve transcatheter aortic valve implantation system, which is two years behind competitor Edwards Lifesciences Corp. (NYSE:EW) in the U.S. market, at the European Society of Cardiology Congress 2011 conference in Paris today.

AMA To Warn PCORI Against Factoring Cost Analysis In Its Research - InsideHealthPolicy.com

AMA To Warn PCORI Against Factoring Cost Analysis In Its Research - InsideHealthPolicy.com: In a comment letter to the Patient-Centered Outcomes Research Institute (PCORI), the American Medical Association plans to probe the board of government-sponsored medical research on whether it intends to consider cost analysis -- something it's forbidden by law from doing, as health care providers fear it may end up restricting their decision-making.

CMS Takes First Step Toward Predicting Long-Term Health Effects Of Provider Cuts - InsideHealthPolicy.com

CMS Takes First Step Toward Predicting Long-Term Health Effects Of Provider Cuts - InsideHealthPolicy.com: CMS’ actuary is taking initial steps toward understanding the long-term health-care effects of cutting provider pay, and insuring young adults, by requesting two research proposals. One of those requests for proposals would measure the long-term effect of Medicare cuts on the quality of health care and the other seeks to estimate the savings, or cost, of making young adults buy health insurance, which is one of the most controversial pieces of the Affordable Care Act (ACA).

FDA Eyes Regulatory Science Centers In D.C. Area, Possible Expansion - InsideHealthPolicy.com

FDA Eyes Regulatory Science Centers In D.C. Area, Possible Expansion - InsideHealthPolicy.com: FDA is reviewing applications to establish regulatory science centers in the Washington, D.C. area, executing a strategy outlined in a 2007 report and building on a joint initiative with Arkansas to create a virtual regulatory science hub, with the regional pilot project possibly expanding nationwide, a top FDA official said late last week.

NIH finalizes financial conflict of interest rules-washingtonpost.com

NIH finalizes financial conflict of interest rules-washingtonpost.com: The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies.

Corporations pushing for job-creation tax breaks shield U.S.-vs.-abroad hiring data - The Washington Post

Corporations pushing for job-creation tax breaks shield U.S.-vs.-abroad hiring data - The Washington Post: Some of the country’s best-known multi­national corporations closely guard a number they don’t want anyone to know: the breakdown between their jobs here and abroad. So secretive are these companies that they hand the figure over to government statisticians on the condition that officials will release only an aggregate number. The latest data show that multinationals cut 2.9 million jobs in the United States and added 2.4 million overseas between 2000 and 2009.

Clinical Study Guide Could Erode FDA's Least Burdensome Trial Policy - InsideHealthPolicy.com

Clinical Study Guide Could Erode FDA's Least Burdensome Trial Policy - InsideHealthPolicy.com: Proposed FDA guidance for designing high-quality clinical studies in support of medical device premarket approval applications could conflict with previous agency policy for sponsors to conduct the most appropriate trials that might not include a random, double-blind investigation, according to industry sources.

What if the mandate goes? - POLITICO.com

What if the mandate goes? - POLITICO.com: If the Supreme Court strikes down the individual mandate at the heart of President Barack Obama’s health care law, Congress may have to “fix” the rest of the law to prevent a disaster.

FDA releases new guidance on postmarket surveillance | MassDevice - Medical Device Industry News

FDA releases new guidance on postmarket surveillance - MassDevice: The FDA is on a roll, releasing yet another draft guidance on medical device regulations this week, this time providing an overview of the postmarket surveillance program and procedural information on how companies should comply.

Hospitals Gripe About IPPS Rule Change Targeting Hospital-Owned Practices

Hospitals Gripe About IPPS Rule Change Targeting Hospital-Owned Practices -InsideHealthPolicy.com: "Some hospital advocates are upset with the Aug. 1 Inpatient Prospective Payment System (IPPS) final rule that subjects hospital-owned practices to payment rules currently applicable to practices not owned by hospitals, in an effort to recoup overpayments. The rule requires hospitals to bundle, in inpatient claims, outpatient services performed for Medicare beneficiaries three days before admission -- including outpatient services provided by physician practices that are “wholly owned or wholly operated” by the hospital. Under the regulation, hospital-provided outpatient nondiagnostic services given on or up to three days prior to admission must be billed as Medicare inpatient claims."

‘Comparative effectiveness research’ tackles medicine’s unanswered questions - The Washington Post

‘Comparative effectiveness research’ tackles medicine’s unanswered questions - The Washington Post: "Nobody familiar with American medical care in the 21st century should be surprised that a 73-year-old woman can be minutes away from getting a painful collapsed vertebra filled with liquid plastic and it’s impossible to say whether the procedure works, or how."

Health-Law Mandate Ruled Unconstitutional by Appeals Court - WSJ.com

Health-Law Mandate Ruled Unconstitutional by Appeals Court - WSJ.com: "A U.S. appeals court in Atlanta handed the Obama administration its biggest defeat to date in the battle over the health-care overhaul passed last year, ruling the law's mandate on Americans to carry health insurance was unconstitutional."

How to encourage American innovation - The Washington Post

How to encourage American innovation - The Washington Post: "With the debt-ceiling crisis over for now, President Obama has tried to turn the conversation to “new jobs, higher wages and faster economic growth.” Among the developments that could spur such improvements, the White House says, are tax cuts for the middle class, congressional approval of stalled trade deals and — yes — patent reform."

Medicare cost-cutting board is under fire - The Washington Post

Medicare cost-cutting board is under fire - The Washington Post: "Even as congressional leaders launch the “supercommittee” charged with making major inroads with the nation’s debt, Republicans and health industry lobbyists are waging a sustained campaign against a panel with notably similar goals and powers that is a centerpiece of the new health-care law."

GOP Super Committee Picks Spark Mixed Reactions From Health Care Lobbyists

GOP Super Committee Picks Spark Mixed Reactions From Health Care Lobbyists - InsideHealthPolicy.com: "House Republicans' selections Wednesday (Aug. 10) for the debt limit law's super committee are generating mixed reactions among stakeholders, with two of the members -- Ways and Means Chair Dave Camp (MI) and Energy and Commerce Chair Fred Upton (MI) -- viewed as “pretty reasonable” to health care providers up to now, according to one lobbyist, but House Republican Chair Jed Hensarling's (TX) appointment generating unease among some who fear he may be willing to entertain Medicaid and children's health program cuts."

Choice Of Baucus, Kerry, Murray For Super Committee Has Lobbyists Buzzing On Implications For Providers

Choice Of Baucus, Kerry, Murray For Super Committee Has Lobbyists Buzzing On Implications For Providers - InsideHealthPolicy.com: "Senate leadership's decision to tap Senate Finance Chair Max Baucus (D-MT) and Democrats John Kerry (MA) and Patty Murray (WA) to the debt limit law's “super committee” charged with finding at least $1.5 trillion in cuts has health care lobbyists buzzing over the potential implications, with Baucus' unexpected appointment viewed as good news for Medicare and Medicaid advocates, Kerry bringing with him years of support for teaching hospitals, home health and medical devices, and Murray entering as a strong reproductive rights and drug reimportation supporter."

Health Reform Insider - August 8, 2011

Health Reform Insider - August 8, 2011 - InsideHealthPolicy.com: "There has been stronger interest among stakeholders in the Pioneer ACOs than in the health reform law's ACOs for Medicare that were outlined in CMS' proposed rule in March. Pioneer ACOs are viewed as more flexible in such areas as payment methodology, payor participation and assignment of beneficiaries into the ACOs. However, several aspects of the Pioneer demonstration are dependent on the final ACO rule, such as the number of quality measures Pioneers will have to meet."

The Unknown Frontier of Identifying Quality Health Care - Meghan McCarthy - NationalJournal.com

The Unknown Frontier of Identifying Quality Health Care - NationalJournal.com: "The Obama administration’s signature health law ushered in a new era of tracking how well doctors and hospitals perform, but the new science of quantifying the quality of health care is complex and leaves a lot to be determined."

IOM's 510(k) Reform Proposals To Have Limited Impact On MDUFA Talks

IOM's 510(k) Reform Proposals To Have Limited Impact On MDUFA Talk - InsideHealthPolicy.com: "The Institute of Medicine's controversial recommendation to scrap the 510(k) device clearance process is unlikely to affect stalled medical device user fee negotiations, sources said, noting that even though FDA indicated it will not use the expert group's proposal, there are still unknown regulatory factors facing industry that are not addressed by the report and could fuel hesitation by product manufacturers to enter a five-year deal. FDA meanwhile pushed forward in the talks, telling device industry stakeholders in a recent meeting that it wants a user fee agreement by the end of the month to meet statutory deadlines, according to meeting minutes."

Who will sit on the Supercommittee?-washingtonpost.com

Who will sit on the Supercommittee?-washingtonpost.com: Can a special committee succeed where Congress has failed in coming up with a deficit reduction deal? It might depend on who’s chosen to be on it.

Debt Deal May Hit Medicare-wsj.com

Debt Deal May Hit Medicare-wsj.com: Medicare beneficiaries escaped direct cuts in Washington's debt deal, but the agreement could eventually hit seniors and disabled Americans who rely on the program for medical coverage.