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Medical Devices

April 24, 2012 | Daily News

Senators will seek to include a drug tracking system, civil monetary penalties for failing to notify FDA of drug shortages and limits on drug patent settlements, among other proposals included in 27 user fee amendments, obtained by Inside Health Policy, filed by lawmakers in preparation for Wednesday's health committee markup.

April 20, 2012 | Daily News

Rep. Michael Burgess (R-TX) signaled support for ensuring FDA can reject medical device 510(k) clearances based on a recalled predicate, with the lawmaker being the first Republican to publicly express interest in the idea for which Democrats in Congress and safety advocates have working to build support. The lawmaker, however, questioned at a House hearing Wednesday whether FDA could implement the approach using its current authorities and requested specific examples of when unsafe medical devices have cleared the agency.

April 20, 2012 | Daily News

It could be difficult to translate a narrowly written device predicate nullification proposal into legislative language with undefined legal terms like "design flaws" that could create subjective legal areas for FDA, an industry source said, adding that this could pose hurdles for those seeking the proposal's inclusion in user fee legislation. Safety advocates counter that the bill should not be so narrowly written to prevent FDA from having authority to take action, as they continued lobby efforts with letters to congressional committees citing the predicate issue as a top priority.

April 20, 2012 | Daily News

Public Citizen this week sharply criticized House Energy and Commerce draft user fee legislation on the grounds that it would weaken oversight of medical products and fails to include proposals aimed at improving patient safety, such as a predicate nullification measure pushed by safety advocates. The group outlined its concerns in a letter to the health subcommittee, which released a new user fee discussion draft on Tuesday (April 17).

April 19, 2012 | Daily News

Durable medical equipment suppliers say CMS' plan to group several types of products in bidding categories as part of its newly announced plan to recompete the supplier contracts from the first round of the competitive bidding program will hurt small businesses, which will lead to higher prices, and the American Association for Homecare is putting together recommendations for CMS on how to recategorize products.

April 18, 2012 | Daily News

In it's first year, Medicare's medical equipment competitive bidding program reduced costs by 42 percent in the nine metropolitan areas in which it was implemented, and CMS officials say the program did not hurt beneficiaries' health or their access to supplies and services. The newly released savings estimates, which are higher than previous estimates of 32 percent and represent an actual savings of $202 million, come as CMS moves to expand the program nationwide due to a health reform law mandate.

April 18, 2012 | Daily News

In an unexpected move, CMS on Tuesday announced plans to recompete the supplier contracts from the Round 1 rebid Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program, which the agency is required to do at least once every three years. The recompete includes a new product category of external infusion pumps and supplies, and also includes new product category groupings.

April 13, 2012 | Daily News

HHS Office of the Inspector General data suggest that Medicaid Fraud Control Units may be more effective than Medicaid Integrity Contractors, with MFCUs returning more than $8.00 for every dollar spent while MIC programs cost almost twice as much to run as they take in. But sources caution that while both programs are tasked to look for suspected fraud, the different methods used and the scope of their efforts could help explain the different returns from the programs.

April 13, 2012 | Daily News

FDA should have the authority to share information with international regulatory agencies and adopt a medical product track and trace system that centers on interactions with trading partners, known as a one-up-one-back system, according to a recent Institute of Medicine report on the safety of imported food and drugs. The report emerges as lawmakers debate supply chain security measures that could be attached to FDA user fee legislation, with information sharing and drug tracking two of the more contentious components.

April 12, 2012 | Daily News

Congressional committees working on the reauthorization of FDA user fees, including a fee for the health reform-created biosimilars review pathway, could begin marking up bills the last week in April, sources said, with the Senate health committee planning to convene a markup the week of April 23. A bipartisan draft is expected from the House Energy and Commerce Committee in the coming weeks, a source said, noting that both chambers still have to address gaps in their legislative measures.

April 04, 2012 | Daily News

Safety advocates continue to push for stronger conflict-of-interest requirements as part of legislation reauthorizing user fees as draft bills in the House and Senate remove caps on the number of waivers FDA can grant and they are also working to pass a law reforming federal advisory committees that could also apply to FDA panels if repeal efforts succeed. However, a congressional aide said any changes to the conflict-of-interest measure in the draft Senate bill are unlikely and sources expressed apprehension over the Federal Advisory Committee Reform Act becoming law soon.

April 04, 2012 | Daily News

House Energy and Commerce Republicans are pushing FDA to justify several policy changes they say the agency is proposing in a draft guidance on in vitro diagnostics for research and investigational use, largely echoing concerns raised by industry over the agency's definition of intended use, regulation of clinical laboratories and a requirement that manufacturers must ensure end users are compliant with regulations.

April 04, 2012 | Daily News

As part of a sizeable stakeholder effort to improve health care quality and reduce patient harm and waste, nine physician specialty societies -- including the American Academy of Family Physicians, the American College of Radiology and the American Society of Clinical Oncology -- have identified 45 commonly-used tests that they say are often unnecessary and whose use physicians and patients should question.

April 02, 2012 | Daily News

FDA's top device official on Thursday (March 29) signaled support for a measure to narrowly prohibit devices recalled for safety design flaws from being used as predicates -- similar to a measure being pushed by a Democratic lawmaker. At least one Democratic Senator expressed support for including this predicate nullification measure in legislation reauthorizing FDA user fees during a Senate health committee hearing on the issue.

March 28, 2012 | Daily News

FDA's top device official said he will raise issues with guidance, tracking and third-party review legislative proposals among others, and hone in on reforms included in a House draft of FDA user fee reauthorization, previewing for FDA Week what he may tell lawmakers as the legislative process continues. FDA will soon transmit the medical device user fee agreement to Congress and device center chief Jeffrey Shuren said the agency has concerns that other pending reforms could conflict with what FDA negotiated with industry in the agreement.

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.

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