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Medical Devices

August 15, 2012 | Daily News

CMS announced on Monday (August 13) that it is immediately discontinuing a hospital quality reporting measure used in determining whether hospitals properly care for heart-attack patients after FDA recalled devices that many hospitals were using to monitor compliance with the measure.

August 02, 2012 | Daily News

CMS plans to launch a controversial power wheelchair prior authorization demonstration on Sept. 1 in seven states, the agency announced Wednesday (Aug. 1), and some industry stakeholders say that the revamped program, which is less expansive than an earlier version which was originally delayed due to provider and lawmakers' concerns, may still jeopardize beneficiary access to power wheelchairs.

August 01, 2012 | Daily News

A group of 23 high-profile health policy experts on Wednesday (Aug. 1) floated far-reaching proposals to cut back health care spending that include moving to a system that would allow states to promote payment rates within a global spending target, requiring exchanges to be active purchasers and to offer at least one “tiered” product, using competitive bidding for all commodities in the federal health system and the insurance exchange, expanding the ban of self-referrals to cover private insurers, requiring full price transparency and encouraging less restrictive state scope of practice laws.

August 01, 2012 | Daily News

CMS Deputy Administrator for Program Integrity Peter Budetti says the agency's new anti-fraud Command Center will pay for itself many times over, despite Senate Finance Committee Republicans' concerns that the agency's new predictive analytics hub, which pulls together all aspects of the agency's program integrity efforts, may not be necessary.

July 31, 2012 | Daily News

Emergency care groups applauded the National Institutes of Health for creating a new office for emergency care research and said the office, unveiled Tuesday (July 31) following years of discussions with stakeholders, was a significant advance for emergency medicine investigators and emergency patients.

July 24, 2012 | Daily News

Community pharmacists warned CMS on Monday that they might stop selling retail diabetic testing supplies if the agency follows through on a plan to bring Medicare reimbursement for such supplies in line with lower mail-order prices using a controversial and rarely used “inherent reasonableness” tool, but agency officials said the cuts would occur soon regardless of whether that tool is used or retail supplies are instead put into the competitive bidding program.

July 20, 2012 | Daily News

Stakeholders said proposed FDA x-ray labeling, which cautions against the device's use in children if there is not data to back up the pediatric use, could force hospitals to use the devices off-label and proposed alternatives, including labeling with the intended use of the device.

July 19, 2012 | Daily News

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.

July 17, 2012 | Daily News

HHS last month asked its Office of Inspector General to investigate the premarket review process for some medical device applications that have been caught up in FDA's controverisal employee monitoring activities, FDA said in a recent letter to Sen. Chuck Grassley (R-IA), responding to the senator's months-long probe into the employee surveillance policies.

July 13, 2012 | Daily News

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.

July 05, 2012 | Daily News

Once pending user fee legislation is signed into law FDA will need to speed up by one year its proposed timeline for applying the Unique Device Identifier system to some implantable devices to follow the new law's requirements, agency device center officials said Tuesday (July 3) as they rolled out a long-awaited UDI proposed rule.

June 27, 2012 | Daily News

BOSTON -- FDA and drug company officials said they are optimistic the agency will meet drug performance goals this time around despite the user fee bill's significant changes to the review process and the slew of reforms attached.

June 27, 2012 | Daily News

The FDA Safety and Innovation Act cleared Congress with a 92 to 4 Senate vote Tuesday (June 26) after Sen. Richard Burr (R-NC) spoke for hours on the Senate floor pointing out shortfalls of the bill, which he said was unnecessarily rushed through Congress ahead of the Supreme Court ruling on health reform and, given extra time, could have resolved several issues, including the creation of a federal track and trace system.

June 26, 2012 | Daily News

The authors of a new study that reveals metal-on-metal hip implant manufacturers initiated FDA-mandated post-market studies for only 24 of 104 products last year are hopeful that device reforms moving through Congress will avert such lags in the future, but also urge FDA to go a step further and pursue a comprehensive national device postmarket safety registry.

June 22, 2012 | Daily News

Companies developing mobile medical applications are pleased lawmakers left out of the final FDA user fee legislation a contentious Senate provision that would have slowed up FDA's issuance of a final mobile app guidance by requiring an outside working group first report to Congress on a proposed regulatory framework.

June 20, 2012 | Daily News

Lawmakers, brushing aside concerns from a major medical device trade group, included in the final FDA user fee bill a provision requiring FDA to notify Congress 60 days before issuing guidance regulating laboratory developed tests.

June 20, 2012 | Daily News

The device provisions in the final FDA user fee bill are getting mixed reactions from industry and consumer safety advocates with both applauding the timeline for issuance of a Unique Device Identifier rule and addition of devices to FDA's Sentinel initiative, but raising competing concerns about FDA's new flexibility to reclassify devices.

June 11, 2012 | Daily News

CMS Deputy Administrator for Program Integrity Peter Budetti said CMS is “looking at the restructuring of our entire [Medicaid] audit program so that we can use those resources in a much more effective way,” as House members slammed CMS over the handling of its contractor-run audit programs in hearings by two committees Thursday (June 7) and Friday (June 8).

June 07, 2012 | Daily News

Industry and lawmakers are turning their attention to the Senate following House passage Thursday (June 7) of a bill repealing the health reform-created medical device tax. Despite opposition to the bill from Senate leadership and a veto threat from the president, the medical device industry said it will continue its push for repeal in the upper chamber.

June 07, 2012 | Daily News

Rep. Ed Markey (D-MA) is calling on HHS Secretary Kathleen Sebelius to provide a detailed account of how the impending budget sequester will be applied to department programs and how the funding cuts will affect medical research and development, access to new medical treatments and other HHS programs.