Panel Seeks Overhaul in Medical Device Regulation-wsj.com

Panel Seeks Overhaul in Medical Device Regulation-wsj.com: An influential outside panel called Friday for an overhaul in medical-device regulation, saying the Food and Drug Administration should give more intense scrutiny to a broad class of devices that currently receive only an abbreviated review before going on the market.

Burr threatens to hold up major FDA bill - The Hill's Healthwatch

Burr threatens to hold up major FDA bill - The Hill's Healthwatch: "Sen. Richard Burr (R-N.C.) said Thursday that he will delay the passage of a major Food and Drug Administration reauthorization unless the agency speeds up its approval of medical devices. The agency agrees to review products in a certain timeframe in exchange for the industry fees that pay for reviews. Burr doesn't want the FDA to be able to stop the clock on its performance goals while it waits for more information from manufacturers."

Faster approval will allow new devices to reach patients more easily.

Key Senators Eye Supply Chain, Device Add-Ons To Upcoming FDA User Fee Bill

New medical device policy provisions can be expected by the end of September 2012:

Key Senators Eye Supply Chain, Device Add-Ons To Upcoming FDA User Fee Bill - Inside Health Policy: "The top Democrat and Republican on the Senate health panel signaled Wednesday (July 27) that they intend to add various new policy provisions to a likely omnibus drug and medical device user fee bill set for passage by the end of September next year, floating possible changes to the supply chain and device reviews as add-on options. Sens. Tom Harkin (D-IA) and Mike Enzi (R-WY) -- chair and ranking member of the health committee, respectively -- said they would work on a bipartisan basis to reauthorize FDA drug and medical device user fees, along with establishing new user fees for generic pharmaceuticals and products in the health reform-created biosimilars pathway."

FDA's 510(k) Guide Could Mandate Off-Label Use Listing, Impact Practice Of Medicine

This guidance is part of FDA's overall review of the 510(k) process, which is expected to culminate later this week with recommendations from IOM:

FDA's 510(k) Guide Could Mandate Off-Label Use Listing, Impact Practice Of Medicin - Inside Health Policy: "FDA's new policy outlining when 510(k) clearance applications are necessary for modified medical devices reverses the agency's stance of not requiring submissions when adding home use indications to labels and delves into the practice of medicine by requiring manufacturers to factor potential off-label uses into their design changes, an industry attorney said. The policy -- outlined in a guidance document released Tuesday (July 26) -- is part of the agency's plan to revamp the 510(k) process, with a highly anticipated Institute of Medicine report due out Friday (July 29) that is expected steer how the agency reforms the device clearance pathway."

Health care providers embracing cost-saving groups - USATODAY.com

Between 60 and 80 health care organizations use private accountable care models now, and that number will rise by at least 100 next year as the Medicare pilot program begins.

Health care providers embracing cost-saving groups - USATODAY.com: "WASHINGTON — Health care providers are embracing accountable care organizations, a key part of last year's health care law, as they try to control rising Medicare and health care costs."

New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays | MassDevice - Blog entry

Internal FDA study reveals deficiencies in 510(k) process and highlights areas for potential improvement.

New FDA study: Insufficient 510(k) submissions causing bulk of 510(k) review delays - MassDevice: "A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays."

FDA announces public workshops for medical device tracking system - MassDevice

In an effort to increase the amount of post-market surveillance of Class II and Class III medical devices, the FDA is going ahead with their plan to examine the creation of Unique Device Identifiers.

FDA announces public workshops for medical device tracking system - MassDevice: "The FDA announced open registration for a series of workshops on the 'adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems.'"

Gang of Six plan looks to health for savings - POLITICO.com

Gang of Six plan looks to health for savings - POLITICO.com: "The bipartisan proposal to end the debt-limit crisis that was seemingly gaining traction on Capitol Hill and at the White House Tuesday would look to cuts and reforms in health care spending to save more than $200 billion."

Health lobby likes McConnell plan - POLITICO.com

Health lobby likes McConnell plan - POLITICO.com: "The complex Senate plan to boost the nation’s debt limit in short order, paired with a promise to slash federal spending on the back end, could give the health care sector a potentially fairer shake even though its lobbyists still expect Medicare and Medicaid to be in play."

Medicare doesn’t cover many health-care expenses for low-income seniors - The Washington Post

Medicare doesn’t cover many health-care expenses for low-income seniors - The Washington Post: "Nearly half of Medicare recipients have incomes at or below 200 percent of poverty - $21,780 for an individual, $29,420 for a couple."

Can a federal health exchange work? - POLITICO.com

Can a federal health exchange work? - POLITICO.com: "Will there really be a strong federal health insurance exchange to take over for states that don’t build their own? Or is it a paper tiger? That question is nagging at some policy experts following last week’s release of the proposed federal rules on the new state health insurance marketplaces, which are supposed to be set up in every state by 2014 under President Barack Obama’s health reform law."

Congress tees up crucial votes on debt limit - The Washington Post

Congress tees up crucial votes on debt limit - The Washington Post: "A bipartisan effort in the Senate to allow President Obama to raise the federal debt ceiling in exchange for about $1.5 trillion in spending cuts over 10 years gained momentum Sunday, as leaders agreed they would have to act in the next two weeks to avert a potential default by the U.S. government."

GOP dilemma: How to oppose IPAB - POLITICO.com

GOP dilemma: How to oppose IPAB - POLITICO.com: "Republicans can’t seem to decide whether they want to lambaste the health reform law’s Independent Payment Advisory Board or present a more moderate tone. In theory, Republicans say they’re convinced that repealing the IPAB will be easier if they don’t make it political — or as nonpolitical as anyone can make health care reform. But it might be too tempting for some lawmakers to let it go quietly."

Cuts Would Only Shift Health-Care Costs-wsj.com:

Cuts Would Only Shift Health-Care Costs-wsj.com: The $350 billion or so in potential cuts to Medicare and Medicaid over 10 years that were identified in budget negotiations would shift the cost of medicine to public hospitals, the states and individuals, but wouldn't do much to tackle rising health-care costs themselves.

Harry Reid: Entitlement cuts need big deal - POLITICO.com

Harry Reid: Entitlement cuts need big deal - POLITICO.com: "Senate Majority Leader Harry Reid said Tuesday that for entitlement cuts, it’s go big on a deal or forget it. “I will not touch Medicare and Medicaid for some simple little deal,” he told reporters. Reid said he’d only consider changes to the programs if the deal were large and included tax increases"

Private exchanges offer alternative - POLITICO.com

Private exchanges offer alternative - POLITICO.com: "A small, Midwestern experiment in health insurance could provide a glimpse into the future.
Next month, two insurance companies, Minneapolis-based Medica and Blue Cross Blue Shield of Michigan, will give some subscribers the opportunity to go into an online marketplace and choose from more than a dozen insurance plans — with their employers footing a certain chunk of the bill."

W.H. to agencies: Streamline your rules - POLITICO.com

W.H. to agencies: Streamline your rules - POLITICO.com: "Just days after House Republicans accused several independent agencies of skirting President Barack Obama's regulatory reforms, the White House issued a new executive order to press the issue Monday."

States given flexibility on new health insurance exchanges - latimes.com

States given flexibility on new health insurance exchanges - latimes.com: "The Obama administration moved Monday to ease some requirements on states to help them set up new insurance exchanges in 2014, a key feature of the healthcare law the president signed last year."

Democrats split on Independent Payment Advisory Board - POLITICO.com

Democrats split on Independent Payment Advisory Board - POLITICO.com: "For the past year, Democrats have been mostly united on health care issues, especially in the face of Republican efforts to repeal President Barack Obama’s landmark law. But this week, House Republicans plan to fire their opening salvos against the Independent Payment Advisory Board — an issue on which Democrats are far from united."

Fix: Of grand bargains, Medicare and silver bullets - The Washington Post

Fix: Of grand bargains, Medicare and silver bullets - The Washington Post: "The news that President Obama is privately urging congressional Democrats to consider major changes to Social Security and Medicare as part of a so-called “grand bargain” on the federal debt has considerable political implications."

GOP's IPAB rhetoric backlash - POLITICO.com

GOP's IPAB rhetoric backlash - POLITICO.com: "As Republicans prepare to turn up the heat next week on health care reform’s controversial independent Medicare advisory board, some provider groups are worried that the GOP’s harsh rhetoric could ruin the chances that Democrats will help the repeal effort."

Medicare and Medicaid Chief in race against time - The Washington Post

Medicare and Medicaid Chief in race against time - The Washington Post: "Don Berwick, the administrator in charge of Medicare and Medicaid, was having dinner in Dupont Circle not long ago with five of his predecessors when the conversation veered to how long he could keep his job.

Heart Treatments Overused, Study Says - WSJ.com

Heart Treatments Overused, Study Says - WSJ.com: "Outside of heart attacks, doctors are often too quick to use a common $20,000 procedure to treat patients suffering from coronary artery disease, a new study suggests."

Health care reform 'repeal and replace' plans grind to a halt - POLITICO.com

Health care reform 'repeal and replace' plans grind to a halt - POLITICO.com: "When they took control of the House, Republicans could barely stop talking about their plans to “repeal and replace” the health care reform law. Six months later, they hardly talk publicly about those plans at all. And they’re nowhere close to 'replacing” the law."

Guide to health industries at risk in debt deal - POLITICO.com

Guide to health industries at risk in debt deal - POLITICO.com: "Last year, health care industry groups gave President Barack Obama’s reform plan the support it needed to become law. Now, those same groups are sweating over what might happen in the debt ceiling talks — because their fortunes might be about to change."

Appeals court upholds health-care law’s individual mandate - The Washington Post

Appeals court upholds health-care law’s individual mandate - The Washington Post: "A federal appeals court on Wednesday upheld the most contentious provision of the health-care overhaul law, ruling that Congress can require Americans to carry insurance coverage."

Medicare Will Continue to Cover Expensive Cancer Drugs - NYTimes.com

Medicare Will Continue to Cover Expensive Cancer Drugs - NYTimes.com: "Medicare confirmed on Thursday that it would continue to pay for two expensive cancer drugs that had been at the center of debate — Avastin from Genentech for breast cancer and Provenge from Dendreon for prostate cancer."

Poll finds more trust in IPAB than Congress - The Hill's Healthwatch

Poll finds more trust in IPAB than Congress - The Hill's Healthwatch: "More Americans trust an independent panel to govern Medicare spending than trust Congress with the program, according to a new poll."

Medtronic spent $1.3M on lobbying in first quarter - Forbes.com

Medtronic spent $1.3M on lobbying in first quarter - Forbes.com: "WASHINGTON -- Medtronic Inc., the world's largest medical device maker, spent nearly $1.3 million lobbying Congress on issues affecting its products in the second quarter, according to a recent disclosure form."