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Medical Devices

March 17, 2012 | Daily News

A draft Senate medical device reform bill being circulated for comment addresses some issues raised by stakeholders and included in previously introduced legislation -- including reform of the de novo pathway, humanitarian use device profits and conflict-of-interest rules -- while also introducing other concepts, including reform of the supervisory review process, a recall evaluation program and the ability of FDA to put a clinical hold on investigational devices.

March 17, 2012 | Daily News

Stakeholders have forged an agreement on humanitarian device reform that embraces a proposal by Sen. Al Franken (D-MN) to allow profits for humanitarian use devices in limited situations -- a deal that comes after pediatricians expressed concern that other proposals would eliminate incentives for pediatric devices with the designation.

March 15, 2012 | Daily News

A bipartisan group of senators on Thursday (March 15) introduced a medical device safety bill aimed at improving post-market surveillance, with the measure adding devices to FDA's Sentinel system and requiring the agency to issue its long-awaited Unique Device Identification rule by the end of the year.

March 13, 2012 | Daily News

The House Energy and Commerce Committee will push accelerated approval changes, antibiotics incentives, drug shortage solutions, a slew of device reforms, changes to the agency's mission statement, mandates for public participation in guidance development and a complete repeal of FDA's conflict-of-interest policies, according to a discussion draft of the committee's user fee package, obtained by FDA Week.The document offers an initial glimpse into the committee's FDA reform priorities and sets up likely debates to occur in the coming months as Democrats prepare to push competing re

March 13, 2012 | Daily News

The American Academy of Family Physicians decided Tuesday (March 13) to stay in a key American Medical Association panel that helps drive CMS physician payment rates after AMA recently conceded to take some steps to increase primary care physicians' role, but AAFP remains concerned the so-called RUC panel is weighted towards specialty physicians.

March 12, 2012 | Daily News

A measure that would create a temporary code for some diagnostics could be dropped from pending legislation if the Obama administration and the American Medical Association address the issue administratively, according to a patient advocate pushing the bill, who says that AMA and CMS have looked into whether the current coding system unnecessarily delays reimbursement and access to diagnostics. Stakeholders have highlighted the coding system for diagnostic tests as an area for reform, saying coding changes could spur access to personalized medicine therapies.

March 02, 2012 | Daily News

Industry and FDA have agreed to a draft commitment letter and legislative language for medical device user fees following the inclusion of a waiver system to exclude laboratory developed tests from the fees, and the agreement is being vetted internally before being released for public comment and sent to Capitol Hill, sources say. The waivers satisfy concerns the American Clinical Laboratory Association had about laboratory developed tests being subject to the fees, but the group will continue to lobby for expanded CMS oversight of these tests in lieu of expected FDA regulation.

March 01, 2012 | Daily News

Industry lobbying groups are bringing state device and bioscience associations to Capitol Hill over the coming months to bolster their push for lawmakers to repeal the medical device tax, ease product approval hurdles and reauthorize FDA user fees, while watchdog groups that oppose the tax repeal and seek tighter approval standards highlight the stepped-up lobbying by medical device companies and their financial contributions to lawmakers.

February 28, 2012 | Daily News

Industry lawyers are bristling at a top FDA official's recent call for companies to back up health economic claims with substantial evidence, with one lawyer saying a requirement for adequate and well-controlled clinical studies may go beyond the statute's less stringent "competent and reliable evidence" benchmark. Industry speakers at a recent marketing conference said the FDA official's statement confirms what they have seen in agency enforcement actions.

February 24, 2012 | Daily News

Congress should consider requiring cost-sharing when Medicare beneficiaries use a preventive service the U.S. Preventive Services Task Force has recommended against due to concern the service has no overall benefit or could cause more harm than good, a new Government Accountability Office report recommends.

February 24, 2012 | Daily News

CMS late Thursday evening (Feb. 23) issued a 455-page proposed rule on the second stage of an electronic-health records program that includes new criteria that hospitals and doctors must meet in return for bonus payments. The second stage uses the same approach as the first stage: most criteria are required and providers are given a list of additional criteria from which they must choose a few.

February 22, 2012 | Daily News

Former CMS Administrator Mark McClellan has floated ways CMS could improve its coverage with evidence development policy, including calling for the agency to work more closely with FDA, Patient-Centered Outcomes Research Institute (PCORI), Agency for Healthcare Research and Quality (AHRQ) and others in and out of government in setting priorities and collecting data.

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.