Medical Device Daily Washington Editor

WASHINGTON – Slowly, surely, the “war on cancer“ is being fought and won. And the lead role of diagnostic imaging in this battle was highlighted in a joint briefing session held yesterday by US Oncology (Houston, Texas) and the National Electric Manufacturers Association (Arlington, Virginia).

Congressman Mike Rogers (R-Michigan) opened the session by remarking that cancer “ought to be an important topic to everybody.“ It obviously is to him since he explained how he had survived cancer while in the Army and that the service wanted to give him a medical discharge upon discovering the diagnosis.

The “C word“ prompted much more fear in the past than it does now. “I had to go through an appeals process to stay in the Army,“ he said.

Roy Beveridge, MD, co-director of the bone marrow transplant program at Inova Fairfax Hospital (Fairfax, Virginia) remarked that “oncology is one of the fastest-changing specialties in medicine,“ largely due to the influence of radiographic technology as well as advances in pharmaceutical science.

Citing figures offered by the American Cancer Society (Atlanta), Beveridge said that almost 4,000 Americans are diagnosed each day with cancer and that, at present, 10 million living Americans have survived cancer. The figure 30 years ago was roughly 3 million.

Among the cancer statistics provided were that almost 1.4 million American men and women are likely to be diagnosed with cancer during 2006, and that more than 560,000 will lose their lives to cancer this year.

Breast cancer alone will account for almost 213,00 of those diagnoses and more than 40,000 fatalities.

Also at the meeting was Joe Hogan, president and CEO of GE Healthcare (Waukesha, Wisconsin), who described his company's efforts in bringing to market digital tomosynthesis, a technology designed to improve detection of breast tumors.

Digital tomosynthesis employs conventional X-rays beamed from an overhead arc to derive a more complete set of images and requires less pressure on the breast to obtain a complete set of scans. Thus it targets three issues related to conventional breast imaging: discomfort due to compression, tumors secreted in overlapping tissue, and a limited number of views. The information is recorded digitally, allowing the use of the latest algorithms to analyze any images of suspect tissues. The machines are expected to displace roughly the same area as the firm's full-field digital mammography systems.

The FDA has not yet cleared the device, but Hogan said he expected the technology to be commercially available “within the next two to three years.“ The device's regulatory status prevented him from discussing the probable price tag for the machines.

Overall, medical imaging is thought not only to improve diagnosis, but also enhance medical and surgical management of cancers by early detection and by improving differential diagnoses.

Beveridge said he was not concerned about the risk of overly aggressive treatment of breast cancer caused by improved diagnostic tools, because “we have very good algorithms“ to establish the origin and likely course of breast cancers.

New ICD registry online

The National Cardiovascular Data Registry, operated by the American College of Cardiology (ACC; Bethesda, Maryland), now includes the National ICD Registry that replaces QNet, a registry operated by the Centers for Medicare & Medicaid Services (CMS; Baltimore).

ACC designed the National ICD Registry in partnership with the Heart Rhythm Society (Washington) to improve on what the two sponsors described as the “bare-bones“ nature of QNet, which collected but did not analyze incoming data on the implantation, use and outcomes of implantable cardioverter defibrillators, or ICDs. QNet will expire April 30.

“The new registry for Medicare patients receiving [ICDs] is helping us meet our goals of increasing patient safety and ensuring the best care possible for heart patients,“ said Stephen Hammill, MD, who chairs CMS's ICD Registry National Working Group.

More than 1,300 hospitals have been contacted to enroll in the registry, which will collect no registration fees in 2006. Fees in 2007 for the registry, which attained official status on April 3, may be as much as $3,000.

The incentive behind the registry for CMS has largely to do with increased coverage for ICDs, for which nearly half a million Medicare enrollees may now be eligible. CMS requires hospitals that collect fees from CMS for such procedures to forward the relevant data to the registry, information from which will be available to the public as well as to physicians and hospitals.

CMS chief Mark McClellan stated that the registry is “part of CMS' Coverage with Evidence Development initiative, which helps ensure that patients receive access to important treatments while facilitating the collection of evidence“ that will aid in the effort to make best use of American healthcare dollars. “Better evidence means better decisions by doctors and patients,“ McClellan added.

CMS ramps up 'Medicaid Integrity Program'

Dennis Smith, director of the Center for Medicaid and State Operations at CMS, reported to the Senate on March 28 on the status of CMS's Medicaid Integrity Program. Smith noted that CMS was still “planning the implementation“ of the program, which Congress mandated with the Deficit Reduction Act of 2005.

Smith's numbers indicated that the agency had appropriated “an additional $5 million“ for fiscal year 2006, and would allocate $50 million in FYs 2007 and 2008. Thereafter, the budget for the program would increase to $75 million annually.

“From these amounts, the Secretary must add an additional 100 full-time equivalent employees whose duties consist solely of protecting the integrity of the Medicaid program,“ Smith observed.

The Deficit Reduction Act also requires that each state maintain a claims processing and data storage system known as a Medicaid Management Information System, which must include a surveillance and utilization review subsystem that enables analysis of provider utilization patterns to detect “fraudulent, abusive, unnecessary and/or inappropriate utilization.“ Smith added that these state systems must undergo federal certification before CMS will fund them, and are expected to consume $1.6 billion federal tax dollars in FY 2006 and roughly one quarter that amount from state coffers.

CMS and the state of California agreed in 2001 to conduct an audit program that combines both state and federal data on the Medicare and Medicaid programs in an effort to root out fraud and inappropriate billing practices. Known as Medi-Medi, this program is expanding into 10 other states, including Florida, New York and Texas, with plans to “be expanded nationally“ via a “stable funding stream which peaks at $60 million annually by FY 2010,“ according to Smith.

A similar analytical effort for payments to providers in the state of Pennsylvania “identified overpayments to more than 48 pharmacies on a small number of pharmaceutical codes,“ which Smith said cost the state and the federal government “about $20 million, a conservative estimate given the large number of codes yet to be analyzed.“ Smith did not specify which fiscal year this analysis covers, but he expressed optimism that the audits for other states may disclose that “similar overpayments exist.“

Other requirements of the act include a mandate that state Medicaid programs seek reimbursement from “third parties that may be responsible for those costs“ and, as of July 1, “documentary evidence of citizenship or national status“ from Medicaid applicants.