Medical Device Daily Washington Editor
As is widely known, FDA has unveiled an initiative to reduce excess exposure to radiation, but at least some physicians are of the view that the general concern about overexposure is overblown. Still, the agency's new emphasis on safety may hold a silver lining for makers of imaging equipment that do not rely on ionizing radiation to produce diagnostic images, assuming there is a backlash against such modalities.
FDA announced the new emphasis earlier this week, which was fueled by reports of burns during CT brain perfusion scans conducted at Cedars Sinai Medical Center (Los Angeles), a situation that may have resulted in patients getting up to eight times the recommended dosage (Medical Device Daily, Dec. 9, 2009). According to the agency's Feb. 9 statement, the initiative is focused on CT scans, X-ray fluoroscopy, and procedures that depend on the use of radioactive dyes.
The agency states that these procedures "are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures," a list that includes standard medical and dental X-rays and routine mammography procedures. According to FDA, a CT scan of the abdomen incurs "the dose from approximately 400 chest X-rays."
The physician community is clearly not united behind the idea that ionizing radiation is exerting a profound or a large-scale effect on the health of Americans. For example, several physicians who spoke at last year's edition of Transcatheter Cardiovascular Therapeutics are of the view that whatever the risk of such imaging, the benefits are far greater and that there is little in the way of data to suggest a systemic problem (Medical Device Daily, Sept. 25, 2009).
Jeffrey Shuren, MD, director of the Center for Devices and Radiological Health, remarked in the agency's statement, "the amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years" and said the agency's objective "is to support the benefits associated with medical imaging while minimizing the risks." The statement acknowledges "some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging," but nonetheless makes the argument that there is "broad agreement that steps can and should be taken to reduce unnecessary radiation exposure."
The FDA document notes that managing the risks of imaging procedures "depends on two principles of radiation protection," described as "appropriate justification for ordering and performing each procedure, and careful optimization of the radiation dose used during each procedure."
FDA wants manufacturers "to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners." Examples of this approach might include dose alerts and data systems that record and transmit total dosage to the patient's electronic health record and to a national registry. The agency also announced a two-day public meeting on March 30-31, "to solicit input on what requirements to establish."
The agency states that it and the Centers for Medicare and Medicaid Services "are collaborating to incorporate key quality assurance practices" into the imaging accreditation requirements for imaging facilities and hospitals, intended to "improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities."
In an e-mailed statement, Michael Graham, MD, President of the Society for Nuclear Medicine (Reston, Virginia), said the association's members are "concerned about overdosing with radiation," which he said is "one of the reasons why we insist on quality across all diagnostic imaging procedures." He also said that SNM, along with several other organizations, seeks to "create national standards for certification and licensure of all nuclear medicine professionals, including physicians and technologists."
Graham also said the issue "emphasizes the urgency for Congress to pass the CARE (Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy) bill, which would ensure that patients receive the same level of care at all accredited facilities nationally."
Outpatient surgery boomerangs on CMS
The law of unintended consequences is well known even to the inhabitants of Capitol Hill, but the Center for Medicare & Medicaid Services may be getting a dose of that same medication if a recent study published in the journal Cancer has any merit.
The article, which appears in the Feb. 8 edition of Cancer, covers an analysis of outpatient bladder cancer procedures performed between 2002 and 2007, comparing the expenditures performed before CMS started reimbursing for outpatient bladder cancer surgery in 2005. According to the authors, "the overall estimated expenditure increased by 50%" after the outpatient code was added.
The abstract (the full article was not available) said that after 2005, the odds of such a procedure ending up in an outpatient setting were roughly 2:1, but that "the likelihood of repeat surgery on the same lesion increased after 2005" by a factor of about 2.86.
SGR patch in the works on the Hill
The fat lady may never sing on the topic of Medicare Part B payments to doctors as long as Congress leaves the sustainable growth rate mechanism (SGR) in place, but doctors nonetheless have little to worry about a 21% cut that is scheduled to land in March if history is any indicator.
According to wire service reports, Senate majority leader Harry Reid said Tuesday that he is looking to bring an $80 billion jobs bill to a vote by week's end, an optimistic worldview given the record-setting snow now blanketing the metro DC area. That bill will include a patch to temporarily bridge the SGR abyss, but the House of Representatives has already declared a "snowmageddon" cessation of work, leaving the issue open until at least Feb. 22. At that point, Congress will have a one-week game of chicken to play with SGR if members of Congress want to avoid further inflaming voters.
Mark McCarty, 703-268-5690