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Medical Devices

May 08, 2012 | Daily News

The Government Accountability Office will release a report and testify on the first round of CMS' competitive bidding program for durable medical equipment (DME) at a Ways and Means health subcommittee hearing Wednesday (May 9), Rep. Aaron Schock (R-IL) told Inside Health Policy. Committee Chair Dave Camp (R-MI) said he disagrees with CMS' decision to make bids nonbinding and that committee Republicans likely will ask CMS officials about that aspect of the program.

May 08, 2012 | Daily News

House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning, with stakeholders also continuing to push for changes to drug shortage and medical device measures.

May 07, 2012 | Daily News

The House Energy and Commerce Committee unveiled a markedly different user fee draft with several additions over past versions, while keeping several controversial medical device provisions such as clarification of the least burdensome standard for product approvals and investigational device exemptions, although scaled back.

May 07, 2012 | Daily News

CMS, facing criticism from key senators for delaying Sunshine Act data collection, has set up an internal work group and will also solicit stakeholders' help as it grapples with how to meet it latest plan to issue a final rule by the end of the year and require manufacturers to start collecting data on financial relationships between doctors and drug and device companies on Jan. 1, 2013.

May 04, 2012 | Daily News

Stakeholders who recently met with FDA and White House Office of Management and Budget officials said they fielded questions on how the upcoming Unique Device Identifier rule would affect recalls and patient safety, with one attendee saying administration officials appear to have moved beyond questions of whether the rule is needed and are now more focused on how it would work. The stakeholders said that they did not get a clear sense of when the delayed rule would be released from OMB.

May 03, 2012 | Daily News

The House Ways and Means health subcommittee plans to hold a hearing May 9 to review CMS' controversial competitive bidding program for durable medical equipment used in the home. The move is good news for medical equipment suppliers who believe the current bidding program is poorly designed and are pushing an alternative concept similar to auctions used in the private sector.

May 02, 2012 | Daily News

FDA is urging industry to develop device interoperability standards to help the agency decide if and how it should regulate such interactions, which have surged with the emergence of mobile health technology, an agency official said. Stakeholders already involved in the development of interoperability standards said FDA's involvement has increased the momentum of industry's efforts in the area.

May 02, 2012 | Daily News

A bipartisan group of senior Senate Finance Committee members is throwing out a broad solicitation for help from the entire health care community to come up with ideas to “better prevent and combat” waste, fraud and abuse in the Medicare and Medicaid programs.

May 01, 2012 | Daily News

FDA has not taken any steps internally to address industry concerns over difficulty in leveraging outside experts to serve on advisory committees, according to a Government Accountability Office report, despite assertions by FDA Commissioner Margaret Hamburg earlier this year that a legislative fix is not needed to address conflict-of-interest policies that may be contributing to problems with filling vacant positions on advisory committees.

April 26, 2012 | Daily News

Safety advocates' press to limit the use of recalled devices as predicates for new device clearances hit a snag after a proposed amendment was shot down by Senate health committee Chairman Tom Harkin (D-IA) at a user fee markup Wednesday (April 25), but the advocates still hope to get the measure attached to the user fee package when it hits the Senate floor.

April 26, 2012 | Daily News

The House Energy and Commerce Committee, after abruptly canceling a planned Thursday (April 26) markup of FDA user fee legislation, will resume its consideration of the bill in a little over a week, setting aside the week of May 7 for subcommittee and full committee markup, according to an updated schedule circulating among lobbyists. Committee Chairman Fred Upton (R-MI) then plans to take the bill to the floor "as soon as possible" under suspension of the rules, according to the schedule.

The following is the committee's updated schedule, according to the document:

April 26, 2012 | Daily News

Senators said they will continue to work on the development of a drug tracking system, a measure limiting drug patent settlements, penalties related to drug shortages and due process concerns related new FDA authorities for destroying unsafe drugs before the health committee-passed user fee bill moves to the full Senate. The committee's top Democrat also appeared to close the door on inclusion of a device predicate nullification as Chair Tom Harkin (D-IA) said he favors the idea but there is not bipartisan support for it and new reclassification authorities could help address the issue.

April 25, 2012 | Daily News

The House Ways and Means oversight subcommittee is the latest congressional panel to launch an investigation into the success of CMS' myriad anti-fraud contractor programs, asking CMS on Wednesday (April 25) to provide details about its fraud-fighting efforts and how the agency gauges its contractors' success.

April 25, 2012 | Daily News

Device safety advocates on Tuesday (April 24) voiced support for a proposed amendment to the Senate user fee bill that would limit the use of recalled devices as predicates, with the amendment tweaking a House Democrat's proposal by clarifying that the measure would only apply to predicates that have been recalled based on a design flaw. The narrowed scope could also draw FDA backing as an agency official recently called for a less-expansive predicate nullification approach than that proposed in the House.

April 25, 2012 | Daily News

The Senate Appropriations Committee will mark up the FDA funding bill Thursday (April 26), the committee announced Tuesday, with funding advocates also anticipating a markup of the House appropriations bill within the next few weeks.

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.

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