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Medical Devices

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.

May 08, 2013 | Daily News

FDA efforts to create an international consortium of transcatheter valve device registries could stall if the agency does not use the registry to reduce postapproval study requirements that have become increasingly burdensome on manufacturers, industry stakeholders recently told FDA officials.

April 29, 2013 | Daily News

Consumers Union is urging senators to oppose legislation repealing the healthcare reform-created medical device tax, saying the “very profitable” medical device industry is capable of absorbing the tax and repealing it would set a precedent for other stakeholders to likewise seek repeal of other provisions funding the Affordable Care Act.

April 26, 2013 | Daily News

CMS officials say durable medical equipment competitive bidding, which is set to send prices plunging come July, will mitigate fraud in the DME sector as the falling prices remove the incentive for bad actors, but senators at a hearing this week did not seem convinced that CMS had a handle on the problem program integrity chief Peter Budetti admitted was plaguing the sector.

April 24, 2013 | Daily News

Acting Administrator Marilyn Tavenner told Senate Finance Committee members the Medicare durable medical equipment competitive bidding program has undergone numerous improvements since it started, including increased scrutiny to avoid low-ball bids, and she assured them there will be more than enough suppliers to provide quality DME products to Medicare beneficiaries when the program expands in July.

April 23, 2013 | Daily News

FDA will develop a multi-stakeholder planning board, finalize the Unique Device Identification rule, promote the development of device registries, modernize adverse event reporting and develop ways to share data as it works to implement its national medical device postmarket surveillance system this year, the agency revealed in an updated postmarket surveillance plan unveiled Tuesday (April 23).

April 18, 2013 | Daily News

The ranking Republican on the Senate appropriations subcommittee with jurisdiction over FDA raised the possibility of exempting agency user fees from sequester cuts during a hearing on Thursday (April 18), with FDA Commissioner Margaret Hamburg also expressing concern that sequestration of user fees could harm future negotiations with industry.

April 10, 2013 | Daily News

Clinical labs, pharmaceuticals and Medicare Advantage stakeholders would be hit with billions in new cuts under the White House budget released Wednesday, which also includes reductions to post-acute care entities and hospitals and structural changes to Medicare that have been proposed in prior budgets.

April 09, 2013 | Daily News

CMS selected 799 durable medical equipment and 18 mail-order diabetic test strip suppliers to participate in round two of the DME competitive bidding and national mail order diabetic testing supply initiatives respectively, as prices for supplies within the program come July 1 will fall on average by 45 percent from fee schedule prices for DME products and will plunge an average of 72 percent for diabetic strips.

April 05, 2013 | Daily News

Industry groups are looking to free up medical product user fees that have been withheld from FDA due to sequestration and to exempt user fees from future budget cuts, changes sources said could happen in next year's spending bill but may not be likely this fiscal year.

March 26, 2013 | Daily News

The medical device industry, buoyed by the Senate's vote in favor of repeal of the healthcare reform-created medical device tax, is now turning its attention to getting the repeal measure included in tax reform or debt ceiling legislation that could be debated this summer.

March 26, 2013 | Daily News

If biopharmaceutical and medical device makers wish to avoid Medicare spending cuts, they should push for ACO performance measures that pay for results, rather than relying on contracts that pay accountable care organizations (ACO) rebates for using more of their products, former CMS Administrator Mark McClellan said. McClellan, who was also FDA commissioner under President George W. Bush, also said ACOs could be the future of personalizing medicine.

March 23, 2013 | Daily News

FDA plans to complete reclassification of all remaining preamendment devices by the end of 2014, an agency device official said Friday (March 22) as FDA issued a proposed order requiring automated external defibrillators to go through the premarket approval process.

March 21, 2013 | Daily News

Sen. Tom Coburn (R-OK) has filed a Senate budget amendment reversing the controversial ACA Medicare wage index provision that results in a financial windfall to hospitals in Massachusetts and several other states, in a move that is viewed as a test vote to gauge support for getting rid of the policy.

March 21, 2013 | Daily News

FDA's device evaluation chief Thursday (March 21) tried to dispel House Republicans' concerns that FDA's emerging policies on regulation of mobile medical apps, smartphones and tablets could subject the devices to the health reform law's excise tax.

March 21, 2013 | Daily News

Republicans on the House Energy and Commerce Committee's health panel will seek ways to give providers and drug manufacturers more clarity regarding off-label uses of drugs as part of an FDA policy agenda that also includes clarifying mobile medical application regulation, incentivizing antibiotic development and creating an FDA board of directors akin to CMS' Medicare Payment Advisory Commission.

March 21, 2013 | Daily News

Medtronic's renal denervation system recently became one of the first devices to join the highly watched FDA-CMS parallel review program, for which little information has been available since the pilot was launched in 2011.

March 08, 2013 | Daily News

A proposed FDA rule updating standards for clinical studies conducted for medical devices outside the United States is consistent with informal policies the agency has used over the years to ensure sponsors collect quality data and protect human subjects, but it codifies and clarifies those policies, an industry attorney said.

March 07, 2013 | Daily News

Diabetes Caucus co-chairs Dianna DeGette (D-CO) and Ed Whitfield (R-KY) are asking the Government Accountability Office to study whether pay cuts for retail diabetic test strips have made those supplies more difficult to find.

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