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Medical Devices

June 21, 2013 | Daily News

Reps. Glenn 'GT' Thompson (R-PA) and Bruce Braley (D-IA) called on the HHS Office of Inspector General to immediately investigate the durable medical equipment competitive bidding program Friday (June 21), asking the agency's investigative arm to probe licensure issues within the program and see if CMS intentionally awarded contracts to unlicensed companies in order to set a predetermined price point for DME.

June 20, 2013 | Daily News

The American Association For Homecare and a medical device supply company sued HHS Wednesday (June 19) to delay the implementation of durable medical equipment competitive bidding, alleging HHS violated its own rules by using bids from DME suppliers without licenses.

June 19, 2013 | Daily News

CMS voided 30 durable medical equipment competitive bidding contracts in Tennessee after finding the suppliers were not properly licensed in the state as they did not have a physical location in Tennessee -- a move that comes as the agency faces growing pressure from lawmakers and medical suppliers to delay the Round 2 bidding effort due to licensing and other concerns that CMS had downplayed.

June 18, 2013 | Daily News

A key Senate appropriator is working to protect FDA user fees from sequestration and has included language in a report accompanying the agency funding bill that highlights the issue.

June 17, 2013 | Daily News

Five healthcare systems, which are building on the work of an FDA demonstration project on the use of Unique Device Identifiers within hospitals, are urging Office of the National Coordinator for Health Information Technology advisers to recommend the inclusion of UDIs in electronic health records.

June 17, 2013 | Daily News

Consumer safety advocates are urging FDA to make the Unique Device Identifier more useful for patients and consumers by creating a portal on the agency's website that would allow users to search for up-to-date safety information about a device.

June 14, 2013 | Daily News

Industry and consumer groups disagree about how much autonomy manufacturers should be given to decide whether a modification to an existing medical device significantly affects its safety, as FDA readies a report to Congress on when such changes warrant submission of a 510(k) premarket notification.

June 11, 2013 | Daily News

CMS is circulating a fact sheet that rejects as “myths” concerns by stakeholders and a growing chorus of lawmakers that the Medicare durable medical equipment competitive bidding program will lead to less competition in the market, lacks transparency and includes unlicensed suppliers.

June 06, 2013 | Daily News

Nearly 150 lawmakers are expected to sign a letter asking CMS to delay until the end of the year round two of the durable medical equipment bidding program because several of the winning bidders are not licensed so they will not be able to supply equipment to seniors, but CMS officials say they are confident suppliers will be licensed by the start of the program.

June 05, 2013 | Daily News

The top Democrat on the House FDA funding panel was unsuccessful in finding a way to allow the agency to access $85 million in sequestered user fees but is working on a measure that would exempt future FDA user fees from the across-the-board cuts.

June 05, 2013 | Daily News

Clinical laboratories Tuesday (June 4) laid out legal evidence and legislative history in a citizen petition arguing that FDA should not regulate laboratory developed tests as medical devices, while also noting that regulating them as such could have ramifications beyond FDA such as subjecting LDTs to the health reform law's device tax.

June 03, 2013 | Daily News

Unique Device Identifiers have garnered increased attention among government advisers discussing meaningful use objectives, according to a device safety advocate hoping to influence critical decisions that could facilitate the inclusion of UDIs in electronic health records.

May 29, 2013 | Daily News

A highly watched medical device pre-emption case pending before the Supreme Court is ripe for high court review as it examines the scope of implied federal pre-emption established by earlier court decisions, attorneys said.

May 28, 2013 | Daily News

FDA should do more research before implementing standard labeling for medical devices, according to the device industry, which is also advocating for flexibility in the agency's approach.

May 23, 2013 | Daily News

CMS will hold its annual meeting in July to hear concerns over pay rates for tests added to the clinical laboratory fee schedule in 2014, which includes molecular diagnostics, the agency announced the day after a bipartisan group of lawmakers introduced a bill aimed increasing pay by overhaul the rate-setting process.

May 23, 2013 | Daily News

CMS plans to create a national Recovery Audit Contractor program focusing specifically on durable medical equipment and home health, according to contractors and an undated statement of work obtained by Inside Health Policy.

May 16, 2013 | Daily News

Medical device manufacturer Medtronic is asking the Supreme Court to decide whether a person can sue a medical device manufacturer under state law for failing to report adverse event information to FDA.

May 16, 2013 | Daily News

Two cases pending before the Supreme Court examining whether actions brought by state attorneys general on behalf of residents should be heard in federal or state court could have implications for drug and device companies, according to attorneys.

May 16, 2013 | Daily News

Diabetic test supply makers will present research to FDA Tuesday (May 21) showing that the quality of supplies varies significantly, and makers of diabetic supplies could use that research to press CMS to shift diabetic test supplies from the Medicare competitive bidding program, where it is difficult for higher-quality products to compete at set rates, to Part D, where drug plans negotiate prices with product makers, sources say.

May 15, 2013 | Daily News

A bipartisan group of key senators has asked CMS why it is not making effective use of durable medical equipment surety bonds to collect on outstanding overpayments to DME suppliers and if surety bond levels should be increased as authorized by the health reform law.