Diagnostics & Imaging Week Washington Editor

The Centers for Medicare & Medicaid Services (CMS) reported recently that it will undertake an analysis of whether it should remove language in one of its national coverage determination statements that bars reimbursement for MRI for angiography studies (MRA). According to the Jan. 20 posting at the CMS web site, the move was prompted at least in part by a Dec. 24, 2008, letter from several physician specialty societies after consultation between the doctor groups and CMS in July 2008.

According to the Jan. 20 CMS posting, CMS proposes to patch over the problem "by specifically removing the phrase 'blood flow measurement' from the nationally non-covered indications" for MRI. The inclusion of the phrase "blood flow measurements" is said to have created confusion when doctors sought to use the procedure as part of a suite of services in a bundled code.

According to the Dec. 24 letter from three specialty societies, "non-coverage of blood flow measurement has been included in the NCD for MRI since 1985," but is in conflict with a separate NCD for MRA. The letter states that the authors of the letter "believe that the reference to blood flow measurement in the NCD for MRI was inadvertently retained when the NCD for MRA was released."

The Dec. 24 letter, which was signed by leaders at the American College of Radiology (ACR; Washington), the American College of Cardiology (ACC; Washington), and the Society for Cardiovascular Magnetic Resonance (Mt. Royal, New Jersey), state further that "Medicare's own contractors also have been confused by the conflicting statements regarding blood flow in the NCDs," leading to problems with reimbursement. "Based on discussions with ... CMS staff on July 23, 2008, we now understand that the solution to this problem requires a reconsideration of the NCD for MRI."

Doctor payment legislation clause 'narrow'

Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wisconsin) have reintroduced the Physician Payment Sunshine Act for the 111th Congress, which would require drug and device makers to report payments and gifts to physicians that exceed $100 per year to the Department of Health and Human Services. The law as currently written is billed as including a federal pre-emption of state reporting requirements, but a staffer with the Senate Special Committee on Aging told Diagnostics & Imaging Week that the bill would pre-empt reporting requirements only for states that have the same or lower level of requirements, not for states that impose a higher standard.

The new iteration of the bill would also trim the frequency of reports required of drug and device makers from the level required in last year's version, from quarterly to annually. The penalties for failure to file those reports, however, could hit $1 million.

According to a statement posted at the web site for the Senate Special Committee on Aging, committee chairman Herb Kohl (D-Wisconsin) said there is "a groundswell of support from every corner" for the bill, and Kohl stated that he is "confident this legislation will pass during the 111th Congress." The statement also quoted the committee's ranking GOP member, Chuck Grassley (R-Iowa), as saying that transparency "fosters accountability, and the public has a right to know about financial relationships."

Kohl's optimism regarding the bill's prospects is shared by Aging committee staff. Ashley Glacel, the committee's press secretary, said in an article by Congressional Quarterly that the bill "has been out there for a year and half, and ... it has been fine-tuned." She described it as "a really smart and strong piece of legislation."

Glacel was unable to tell D&IW which provisions of the bill might spark the most debate in the committee, let alone on the Senate floor. "The version of this from the last Congress was vetted in three hearings," she said, adding that feedback from the states drove the language of the pre-emption provision. She also said that representatives of several states indicated concern "that their stronger laws would be made moot, so we've inserted a very narrow pre-emption clause" that allows states to promulgate tougher laws.

Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement that the association commends the senators "for their continued leadership on this important issue," but he acknowledged that AdvaMed is still looking the bill over. Ubl reiterated the association's belief that "any federal disclosure legislation [should] create a uniform national standard to prevent a patchwork approach by all 50 states." AdvaMed did not respond to a request for further comment.

Mark Leahy, president of the Medical Device Manufacturers Association (Washington), also did not respond.

Interim chief of CDC named

The Obama administration has appointed an infectious disease and disaster preparedness expert to the position of acting director of the Centers for Disease Control and Prevention. Richard Besser, MD, was named in an e-mail message to CDC employees, but it is not clear whether he will take the permanent position. The previous head of CDC, Julie Gerberding, MD, had the job for six years before resigning the job with the change in administration.

A previous announcement had named William Gimson III, the agency's chief operating officer, to the job, but Gimson was seen as an inappropriate choice because he is not a medical doctor.

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