Sean Tunis, MD, chief medical officer for the Centers for Medicare & Medicaid Services (CMS; Baltimore), said there was no conscious decision to "hit the ground running" in 2005, but he acknowledged that the agency, early on, has been pretty busy. "We put out three or four major coverage decisions and three regs within two days [in early February], and nobody I know of would have thought it was a good idea to plan it that way," Tunis told The BBI Newsletter. "That's just the way the timing worked out."

CMS so far has released key coverage decisions on implantable cardioverter defibrillators (ICDs), positron emission tomography (PET) scans, additional "off- label" uses in selected clinical studies for new cancer drugs, and proposed a rule that would modernize the end-stage renal disease conditions for coverage by promoting higher quality care in dialysis facilities that want to participate in Medicare. Add to that the rollout of a new program to pay physician groups based on performance to test financial incentives to reduce cost and improve quality of care, a proposed rule that would increase the Medicare payment rates for long-term-care hospitals, and proposed regulations that will support electronic prescriptions for Medicare when the prescription drug benefit takes effect in January 2006, and you've got a full plate.

Tunis joked that the rather hyperactive lead of CMS Administrator Mark McClellan was really responsible for driving the wheels of productivity with- in the agency. "Seriously, I must say that Mark is a very focused and energetic individual, and he has remarkable capacity to energize folks," Tunis said. "Mark clearly had a hand in pushing the physician group practice demo along to fruition, and the fact the e-prescribing reg got done nine months before it was scheduled to had a lot to with him, too."

Tunis said that the national coverage decisions (NCDs) such as the expanded ICD decision were just part of meeting targets set out in the Medicare Modernization Act of 2003 (MMA). "The national coverage decisions are on an MMA-regimented timeframe, and we have been endeavoring to meet every milestone," he explained. "Since the MMA went into effect in January 2004, we have hit every NCD milestone or beat it in some cases."

He also said that the ICD coverage decision was one of the most important actions CMS has taken recently, both in terms of benefit to patients and in the establishment of multiple registries to follow patients prior to treatment and post-implant. "The registry requirement is not exactly brand-new, but I think it is an important extension of an approach we are hoping to expand significantly in the future," Tunis said. "We are trying to strike a balance between making technology available and making decisions quickly, but at the same time making sure that we have mechanisms in place to learn more as we go along."

Tunis and McClellan recently authored an editorial in the New England Journal of Medicine that outlined the change in methodology in terms of the ICD decision and how CMS will apply the same process to other decision-making. "It will hopefully be a platform to now go forward and figure how we are going to apply that approach more systematically," he said.

Positive molecular breast imaging results

Mayo Clinic (Rochester, Minnesota) researchers reported recently that they have had success in finding smaller tumors in breasts than are typically found with mammograms using a specially designed gamma camera for molecular breast imaging. The rese-archers reported the findings on the gamma camera, which would provide an alternative to mammograms, particularly in women with dense breast tissue, in a report in the January issue of Mayo Clinic Proceedings.

"By optimizing the camera to detect smaller breast lesions, this technique should aid in the detection of early stage breast cancer, something that was not possible with conventional gamma cameras," said Michael O'Connor, PhD, Mayo Clinic radiologist.

The camera, provided to Mayo about two years ago by GE Healthcare (Waukesha, Wisconsin), is a CZT (cadmium zinc teluride), or crystal, detector that was provided for the center to evaluate for breast imaging, said Douglas Collins, MD, also a Mayo Clinic radiologist. The CZT detector was put on a gantry and on a modified mammography unit.

The researchers' study began at that time and "slowly accrued" 40 patients, Collins said. Ninety-six patients are now involved in the study, he said, noting that it has "really taken off." In the study, 40 women with suspicious findings on mammogram underwent molecular breast imaging. Twenty-six women had 36 malignant lesions confirmed at surgery. Molecular breast imaging detected 33 of the 36 lesions. In addition, the researchers said, four cancers were detected that were not seen on mammograms.

Stephen Phillips, MD, another Mayo Clinic radiologists involved in the study, said the technique yielded the "highest sensitivity yet reported for a gamma camera" in the detection of small breast tumors of less than 1 cm, reporting an 86% rate of detection, or 19 of 22 cancers.

Report: GPO claims 'unsubstantiated'

The Medical Device Manufacturers Association (MDMA; Washington) is continuing its criticism of the group purchasing organization (GPO) sector, recently issuing a new challenge to GPOs' oft-repeated claim that they enable hospitals to reap significant savings, thus benefiting the entire healthcare system. MDMA in February issued a statement citing a new report arguing there is no "clear-cut definition" of the purported savings via GPOs. Without such a definition, the organization said, "hospitals will remain vulnerable to unsubstantiated claims of savings while their costs of doing business rise unabated." Titled "Defining and Measuring Product-Based Cost Savings in the Health Care Supply Chain," the report was prepared by Lynn Everard, an independent consultant and "hospital industry supply chain strategist," according to MDMA.

The "safe harbor" exemption from federal anti-kickback rules granted to GPOs by Congress is one target of the report. The exemption enables GPOs to collect legal fees from suppliers to whom they award contracts for hospital supplies, but the report says this exemption is highly questionable as supply prices continue to rise. Everard states in the report: "In almost any other industry, the practice protected by the safe harbor would be considered illegal or at least unethical. While the fees may be legal, their full im-pact on the GPOs' business dealings with manufacturers may never be known . . . ." The report urges the hospital supply industry to commission a pricing study to "trend the pricing of not less than 1,000 medical technologies and commodity line items over a period of not less than 10 years" to establish the im-pact of GPOs on actual hospital pricing.

Everard said he surveyed hospital purchasing officers in order to determine cost savings achieved for the hospitals by GPO contracts. The report states: "An overwhelming 94% of respondents believe that their GPO saves them money. Yet only 29% said they actually knew how much money their GPO had saved them and 80% of those said they knew how much because their GPO told them." Everard proposes that, as a key first step, the hospital supply industry should adopt a definition for "product cost savings," which would include pricing, length of time a price is in effect, purchasing contract terms, the role of list prices in determining cost savings, and a statement of "value."

Mark Leahey, executive director of MDMA, told The BBI Newsletter that the Evarard report isn't focused on taking sides on the issue but simply emphasizes the need for accounting clarity. He added that it also "demonstrates that transparent business behavior is more likely to allow fair pricing and enhance competition in the hospital supply industry. Only by continuing to open up the market, and the practices of certain large GPOs, to public scrutiny will healthcare professionals and the patients they serve gain access to innovative medical technologies that can save lives, at a cost that hospitals can afford."

CMS to revise mobility equipment standards

Navigating between an industry clamor for broader reimbursement of mobility equipment power wheelchairs and scooters and the requirement to cap costs, the Centers for Medicare & Medicaid Services has released new draft criteria and codes that it hopes will skirt both extremes while providing "proper payment." The proposed new criteria would put greater emphasis on "clinical guidance" for evaluating the needs of those seeking the powered devices, it said, as well as "exactly what type of device is needed." This approach would replace the previous standard that defined the appropriate reimbursed patient as "non-ambulatory or bed- or chair-confined," it said.

This broader analysis would begin, the agency said, with whether the beneficiary "has a mobility limitation that prevents him or her from performing one or more mobility-related activities of daily living in the home." This evaluation would also consist of "whether or not an assistive device whether a simple cane or a sophisticated power wheelchair or anything in between would improve the beneficiary's ability to function within the home." The revised criteria also will consider other impairments, such as visual or mental, that impact the patient's ability to use the mobility equipment, according to CMS.

The proposed revisions appear to be a large win for the makers of power wheelchairs and scooters, following roll-out of "Operation Wheeler Dealer," launched by CMS in late 2003. Wheeler Dealer specifically targeted ballooning increases in reimbursements for the devices, with Tom Scully, then-administrator of CMS, reporting a 450% increase in reimbursements during the previous four years. Agency officials said that payments for the power devices had soared from $10 million in 1994 to $1.2 billion in 2003. The much more specific target of the program in-volved soaring reimbursements generated out of the state of Texas, in which the equipment was never provided or the claims were alleged as fraudulent, CMS said.

Restore Access to Mobility Partnership (RAMP; Washington), a coalition representing a group of manufacturers in the sector, charged that a strict interpretation of traditional CMS guidelines had re-sulted in blocking patient access to the mobility equipment by the many thousands of patients who legitimately needed them. And the organization subsequently developed what it termed a "task force" of occupational and physical therapists to push for guidelines using clinically based criteria as well as input from clinicians in the field.