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Medical Devices

February 20, 2013 | Daily News

A newly proposed FDA rule removes a previously floated requirement for device applications to consider “potential” pediatric uses, responding to industry concerns that the initial proposal would have forced companies to speculate about device uses.

February 05, 2013 | Daily News

A major medical device industry trade group is working to enact state measures to counterbalance controversial federal tax and reimbursement policies, including seeking state tax credits to offset costs facing industry from the health reform-created medical device tax and FDA medical device user fees.

February 01, 2013 | Daily News

Following months of pressure to release the health reform law's long-delayed physician-payment disclosure final rule, the Obama administration on Friday (Feb. 1) unveiled a final regulation that gives companies until August to start collecting data, allows physicians additional time to make corrections to information and limits reporting requirements for accredited continuing medical education.

January 31, 2013 | Daily News

CMS, in announcing rates for round two of the controversial Durable Medical Equipment competitive bidding program, said that come July 1 prices within the program will fall on average by 45 percent from fee schedule prices for DME products -- with diabetic strip prices plunging the furthest at an average of 72 percent.

January 30, 2013 | Daily News

FDA's proposed guidance on post-approval modifications for combination products approved under a single application, while narrow in scope, could spur an influx of supplemental submissions as changes to low-risk devices could require supplemental drug applications and fees, according to an attorney representing combination product manufacturers.

January 28, 2013 | Daily News

The Personalized Medicine Coalition is raising concerns that CMS’ plan to apply coverage with evidence development to older products and services indicates the agency wants use the policy in new ways that could restrict beneficiary access to medical products.

January 28, 2013 | Daily News

The National Legislative Association on Prescription Drug Prices Monday (Jan. 28) pressed the Obama administration to move forward on the Patient Protection and Affordable Care Act's sunshine provisions, saying the delayed federal rules have impeded progress on the state level because state lawmakers halted similar efforts to avoid being preempted.

January 28, 2013 | Daily News

A statutory limit on the number of custom devices that qualify for a regulatory exemption outlined in the FDA Safety and Innovation Act has become a point of contention, with a key device industry group saying the five unit limit will not address unmet patient needs while patient safety advocates are calling for strict regulatory controls.

January 23, 2013 | Daily News

With the president's second term in full swing, key health care players in Congress are re-introducing bills that in many instances target the health reform law by repealing certain pieces or adding policies that failed to get in during the 2009 debate. The bills range from establishing a public option in the ACA to repealing health reform provisions dealing with employer penalties and health savings accounts.

January 22, 2013 | Daily News

In about six months combination product manufacturers will have to start complying with good manufacturing practices that were finalized Friday after several years of rulemaking procedures and include a few key changes from FDA's earlier proposal.

January 17, 2013 | Daily News

Drug and device makers, physicians and other advocacy groups have written a slew of letters in recent days asking the White House Office of Management and Budget to release the final rule implementing the Physician Payments Sunshine Act.

January 02, 2013 | Daily News

Congress extended a long list of Medicare payment provisions in the fiscal cliff deal, including a few that had expired, which comes as a relief to lobbyists who had worried that some of the payment “extenders” would not be included in the fiscal cliff package.

December 28, 2012 | Daily News

Medical gas manufacturers will have until July to comply with a new certification process mandated by the recently enacted FDA Safety and Innovation Act and can resubmit rejected certification requests within one month without penalty, according to a draft guidance document outlining the new medical gas certification process.

December 24, 2012 | Daily News

Medical device trade groups are highlighting surveys showing the cost of implementing the health reform law's device tax as they continue lobbying for congressional action to delay and ultimately repeal the $30 billion tax.

December 24, 2012 | Daily News

The company that developed 3D mammography -- or tomosynthesis -- is laying plans to seek Medicare reimbursement for the product next year either through the American Medical Association's CPT code process or by appealing directly to CMS, a source with Hologic tells Inside Health Policy.

December 17, 2012 | Daily News

The IRS' decision to subject combination products that have both device and drug components to possible double taxation under the health reform law yet waive the device tax for custom procedure kits assembled by hospitals has left some in the combination product industry perplexed.

December 12, 2012 | Daily News

CMS' latest list of potential national coverage determination topics was generated almost entirely by the public, and as a result many drug topics included on the earlier 2008 list have been dropped and put “on the back burner,” at least for now, a CMS coverage official said.

December 10, 2012 | Daily News

Senate Majority Whip Dick Durbin (IL), along with 15 other members of the Democratic caucus and two key incoming senators, is urging Majority Leader Sen. Harry Reid (NV) to consider delaying implementation of the health reform law's medical device tax as lawmakers continue fiscal negotiations.

December 08, 2012 | Daily News

The Supreme Court, after declining for years to hear cases examining the legality of drug patent settlements, on Friday (Dec. 7) said it would weigh in on the hotly debated issue, agreeing to hear a so-called “pay for delay” case involving the testosterone gel Androgel.

December 05, 2012 | Daily News

A group representing medical imaging and radiation therapy manufacturers promptly urged Congress to delay implementation of the health reform law's medical device tax following IRS' release Wednesday (Dec. 5) of the final rule on the $30 billion device excise tax.

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