Medical Devices Today

House Bill Targets Imaging Payments To Help Fund Children's Insurance

From the July 30, 2007, issue of "The Gray Sheet"

A rapidly moving Medicare bill puts imaging payments back in the crosshairs as the House looks for cost-saving measures to fund coverage of uninsured children and prevent massive cuts to physician payments.

H.R. 3162, The Children's Health and Medicare Protection Act, passed the House Ways and Means Committee early July 27. The Energy and Commerce Committee was unable to complete its separate markup of the bill later that day due to Republican stalling tactics and will likely send it to the House floor this week without a committee vote.

The activity is driven by a need to reauthorize the State Children's Health Insurance Program, or SCHIP, before it expires on Sept. 30. But the House legislation, first introduced by Energy and Commerce Chairman John Dingell, D-Mich., on July 24, goes much further.

Siemens' Model For The Future Unites Imaging And In Vitro Diagnostics

From the July 23, 2007, issue of "The Gray Sheet"

The business opportunity in linking in vitro diagnostics to in vivo imaging studies is generating significant buzz, and Siemens believes it is currently the only firm positioned to drive this health care model.

The imaging systems powerhouse created an in vitro diagnostics subsidiary, Siemens Medical Solutions Diagnostics, in January with the $5.3 billion acquisition of Bayer's diagnostics division. The subsidiary also integrates in vitro firm Diagnostics Product Corp., which Siemens bought in June 2006.

According to Siemens Medical Solutions Diagnostics CEO Tony Bihl, Siemens' imaging and in vitro diagnostic capabilities, coupled with the purchase of information technology company SMS in 2000, sets the firm apart in the diagnostics arena.

Scrutinizing 510(k)s: Critical Voices Get Heard In Congress

From the July 16, 2007, issue of "The Gray Sheet"

Consumer advocacy groups have recently stepped up efforts to publicly scrutinize FDA's 510(k) premarket notification process for devices and push for a higher burden of proof for getting the products to market.

FDA and industry stand firmly behind 510(k)s, which provide a regulatory pathway for many products to enter the market by showing "substantial equivalence" to an already marketed product, typically without the need for clinical trials. But groups including Public Citizen and the National Research Center for Women and Families are raising concerns and have clearly gotten the ear of some members of Congress.

Most prominently, a provision was inserted into a broad-based FDA bill passed by the House July 11 that charges the Government Accountability Office to study "the appropriate use" of the 510(k) process.

FDA Device Center Working Out "Nuts And Bolts" Of Interactive Review

From the July 9, 2007, issue of "The Gray Sheet"

If all goes as planned, beginning Oct. 1 FDA device reviewers will be taking a new, more interactive approach to product applications, though agency officials are still unsure exactly how the method will work.

Interactive review, a central part of the plan for a new user fee program now moving through Congress, is supposed to improve communications between device reviewers and industry and create more predictable timelines for premarket decisions.

Although Office of Device Evaluation Director Donna Bea Tillman likes the idea of engaging more informally with industry, she says there are several practical questions.

FDA Urges Device Manufacturers To Double-Check Their CAPA Systems

From the June 2007 issue of "The Silver Sheet"

Corrective and preventive action (CAPA) violations were cited in 87% of device warning letters last year, leading FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities.

According to statistics compiled by FDA, 69 out of 79 quality system warning letters sent to firms in calendar year 2006 included at least one CAPA observation.

"I can tell you that from reviewing inspection reports and writing up warning letters, pretty much everything that comes across my desk [includes] some sort of CAPA observation, " Melissa Torres, a biomedical engineer in CDRH's Office of Compliance, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) seminar in Arlington, Va.

A Day In The Life Of CDRH Compliance Officer Cap Uldriks

From the June 2007 issue of "The Silver Sheet"

If Cap Uldriks could tell device firms two things about FDA, this would probably be first: Despite the bum rap it sometimes receives, the agency isn't a secretive organization that plots to make manufacturers' lives miserable by conducting unnecessary enforcement actions and issuing confusing documents.

"A lot of people think the agency is a monolithic, kind of dark thing that you can't penetrate, and we have all this thinking that goes on in soundproof rooms, and we're strategizing like they do at the Pentagon. No," says Uldriks, a consumer safety officer in CDRH's Office of Compliance.

"Once you figure out how we think and how we work, we're really very transparent," he said during a May 16 interview in his office in Rockville, Md.

Radiology Benefits Managers Offer Medicare Cost-Saving Option For Imaging

From the July 2, 2007, issue of "The Gray Sheet"

An insurance company strategy to rein in perceived overuse of imaging services has gained traction in Congress for its potential as a Medicare cost-saver.

The approach: private payers contract with third parties to act as "gatekeepers" for imaging coverage. Radiology benefits managers (RBMs), as they are called, review physicians' imaging study orders, excluding inpatient services, for prior authorization before allowing coverage.

RBMs argue that inappropriate use of high-cost imaging services like computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) happens too frequently and reducing it can increase quality of care and save significant money.