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Medical Devices

March 26, 2012 | Daily News

A vote on legislation to repeal the health reform law's medical device tax could possibly come this spring or summer, according to the Advanced Medical Technology Association, which on Monday (March 26) continued its push for repeal of the tax with the release of a report showing that the decline in revenue associated with the tax would result in the loss of nearly 39,000 jobs and more than $8 billion in economic output, figures that are part of the group's strategy to frame the tax as a job killer in an effort to garner bipartisan support for repeal.

March 23, 2012 | Daily News

A federal appeals court decision to block FDA's requirement that tobacco ads appear only in black and white, part of a larger ruling this week that otherwise upheld the agency's graphic warning labels for cigarettes, is hailed by a free speech advocate as putting a check on blanket bans on speech, such as off-label marketing restrictions, and a move that could require FDA to more narrowly tailor such restrictions.

March 23, 2012 | Daily News

A measure expanding CMS oversight of laboratory developed tests was excluded from a draft House user fee bill, signaling the proposal, which is opposed by a key device industry trade group, might not make it into the final user fee legislation, although lobbying efforts are heating up and some sources predicted the proposal could still move through user fees or other legislation.

March 23, 2012 | Daily News

Rep. Ed Markey (D-MA) is pushing to build bipartisan support and user fee inclusion of a bill that would give FDA the authority to reject 510(k) medical device clearances based on recalled predicates, with the lawmaker releasing a report Thursday (March 22) outlining what he is calling a loophole in the FDA clearance process.

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.

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