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Medical Devices

February 16, 2012 | Daily News

FDA's top medical device official signaled that resources will be key in getting the agency behind legislative reforms pending in Congress, saying that proposals like de novo reform do not require more money, but other pending recommendations such as requiring detailed summaries of agency approval decisions were taken off the table during user fee negotiations because they would divert resources away from meeting user fee goals.

February 14, 2012 | Daily News

A White House budget proposal to save $140 million over 10 years through prepayment review or prior authorization for power wheelchairs came as a surprise to industry as CMS has already scrapped the prepay phase of a recently revived demonstration. The White House power wheelchair proposal, which an industry source tells Inside Health Policy is outdated, is one of 16 HHS policies estimated to save $3.6 billion over 10 years by reducing fraud, waste and abuse in Medicare and Medicaid.

February 10, 2012 | Daily News

Consumer safety advocates are unveiling a broad medical device reform agenda as they increase lobbying efforts on Capitol Hill, with groups focusing on more rigorous approval for implantable devices, restrictions on using recalled predicates, increased requirements for post-market studies, implementation of the delayed unique identifier system and a national device registry, and greater scrutiny of direct-to-consumer medical device advertising. A safety advocate said there is momentum in the Senate to include some reforms in the user fee act legislation.

February 10, 2012 | Daily News

Senate Finance Committee chair Max Baucus (D-MT) has signaled he may push to mandate that hospitals report medical device prices to CMS in response to congressional investigators' discovery of major pricing disparities with implantable devices -- a reporting idea hospital officials tell Inside CMS should instead be directed at the medical device industry and the medical device industry rejects as unnecessary.

February 08, 2012 | Daily News

A bipartisan duo of House lawmakers Wednesday (Feb. 8) introduced a bill that would require FDA finalize a pediatric medical device rule mandating device manufacturers include in applications potential pediatric populations that could benefit from the device, a requirement that the agency withdrew in 2010 after objections from industry. The legislation -- backed by Reps. Ed Markey (D-MA) and Mike Rogers (R-MI) -- would reauthorize a 2007 law that outlines a grant program and profit incentives for pediatric humanitarian use devices.

February 08, 2012 | Daily News

The Advanced Medical Technology Association is repositioning its push for a repeal of the health reform law's device tax as a jobs and economic growth issue in an effort to win over Democrats on Capitol Hill, officials from the group said Tuesday (Feb. 7) as they outlined a broader tax reform plan that includes the device tax repeal.

February 06, 2012 | Daily News

CMS plans to move forward with its delayed power wheelchair demonstration this summer, but revealed on Friday that it will abandon the demo's prepay phase and significantly alter its prior authorization aspect in response to complaints from home medical equipment suppliers. The agency had delayed the prepayment demo after a bipartisan group of 22 House lawmakers in late December urged CMS to halt it, nd now is expected to start demo in June.

February 04, 2012 | Daily News

The Internal Revenue Service took steps Friday (Feb. 3) to address industry concerns about potential double taxation for combination products containing a drug and device under health reform-mandated fees by saying that rarely would a product face both the device excise tax and branded prescription drug fee, but also sought more clarity from stakeholders on the issue. The tax bureau Friday (Feb. 3) posted regulations outlining the reform law's contentious $20 billion device excise tax, prompting further calls from industry and lawmakers for the tax to be repealed.

February 04, 2012 | Daily News

Two key lawmakers on the Senate health committee are pushing legislation to reform the de novo pathway for medical devices that incorporates elements of other proposals that would remove a requirement to enter and be rejected from the 510(k) pathway before being allowed to file a de novo submission, while also addressing concerns about the time FDA has to review these devices. The latest legislative package is expected to become a “baseline” for Senate reform in this area, according to sources.

February 02, 2012 | Daily News

Sen. Chuck Grassley (R-IA) is asking FDA for details on the extent of and policies surrounding the agency's monitoring of whistleblower activities -- including an alleged interception of emails to the senator's investigator -- sending a letter to the agency in the wake of a lawsuit recently filed by six current and former FDA employees. The employees' complaint has sparked charges from Grassley and whistleblower advocates that the agency has wasted resources to monitor employees' legal activities (see related story).

February 02, 2012 | Daily News

FDA informed a bipartisan group of Minnesota lawmakers pushing device reforms that some of their proposals are wrapped into the tentative device user fee deal announced Wednesday, and said the agency would take steps internally to address some of their other concerns, according to sources and a letter FDA sent the lawmakers prior to a Feb. 1 meeting between the lawmakers and agency Commissioner Margaret Hamburg.

February 02, 2012 | Daily News

A group of House Democrats this week introduced legislation to improve the safety of devices cleared through the 510(k) pathway by preventing recalled devices from being used as predicates, a move that follows recent calls by key lawmakers and safety advocates for increased safety measures for implantable devices as part of legislation reauthorizing user fees.

February 02, 2012 | Daily News

FDA Commissioner Margaret Hamburg signaled to House lawmakers Wednesday (Feb. 1) that the agency does not need a legislative fix to address conflict-of-interest policies that may be contributing to problems with filling vacant positions on advisory committees, saying the agency is engaging stakeholders on the issue and regulatory science collaborations could also provide FDA with needed expertise.

February 01, 2012 | Daily News

With a tentative device user fee agreement now in hand, FDA is urging industry negotiators to “remain committed” to the deal as the device industry trade group signaled Wednesday (Feb. 1) it may support additional reforms as the proposal moves through Capitol Hill.

January 31, 2012 | Daily News

FDA is pushing ahead with its innovation pathway for novel medical devices with a pilot project for end-stage renal disease that one stakeholder said could provide inroads to comparative effectiveness research and despite calls from the medical device industry for the agency to focus on bringing greater efficiency and consistency to the overall review process.

January 28, 2012 | Daily News

Free speech advocates are using a district court case as an opportunity to challenge FDA guidance released last year outlining the difference between drugs and devices, with the advocates saying the agency's policy conflicts with the statutory definition of medical devices.

January 25, 2012 | Daily News

The medical device industry and FDA are in the final stages of an agreement on medical device user fees, closing in on a package that includes around $600 million in fees over five years and abandons recent proposals to hike fees in the middle of the program, several sources said. When finalized, the agreement would conclude months of contentious negotiations between the agency and industry over the amount of the fees to be paid by companies, with the talks prompting involvement from FDA's top official and debate on Capitol Hill.

January 21, 2012 | Daily News

Democratic leaders of the House Energy and Commerce Committee on Friday renewed their call for hearings to examine the safety of implantable medical devices ahead of reauthorization of medical device user fees, an area where safety advocates are pushing for a more rigorous premarket approval process. Such oversight could also have implications for CMS coverage and reimbursement policy.

January 17, 2012 | Daily News

Key Senate lawmakers on Friday (Jan. 13) called for FDA and the medical device industry to resolve issues surrounding user fee negotiations as drug agreements – including industry fees for the health reform-created biosimilars pathway – were submitted to Congress ahead of a Jan. 15 statutory deadline. Device talks, however, have been stalled over fee level disagreements, with the agency pushing industry to contribute higher levels of user fees for device reviews.

January 10, 2012 | Daily News

Medical device stakeholders said changes to the de novo approval process and conflict of interest rules are legislative reforms that will likely ride along with user fee legislation, while other device reforms could also be included in the agreement being negotiated by FDA and industry. The agency's use of its post-market authority for medical devices is also likely to be a major and possibly contentious issue as the user fee bill is debated on Capitol Hill, while safety advocates said they plan to push for the more rigorous premarket approval process for all implantable devices.

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