Hold Sought on Imaging Pay Cuts
With Medicare due to slash payments for imaging services by 35%–55% in January 2007, provider organizations are rallying to delay or repeal the cuts, which call for payments for the technical component—equipment, supplies, and overhead for imaging services—to be reimbursed at the hospital outpatient payment rate if it is lower than the physician fee schedule. At a hearing of the House Energy and Commerce Health Subcommittee, Democrats and Republicans said they were concerned the reductions were enacted without public input and without any assessment of the impact on beneficiaries. The cuts were inserted into the Deficit Reduction Act during a House-Senate conference; the act was signed in February 2006. “We don't know exactly what we've done, or how well or how poorly we've done it,” said Rep. John Dingell (D-Mich.) at the hearing. H.R. 5704, sponsored by Rep. Joseph Pitts (R-Penn.), would institute a 2-year moratorium. Many medical organizations voiced objections to the cuts, including the American College of Cardiology, the Society for Vascular Surgery, and the Society for Cardiovascular Angiography and Interventions. The ACC “cautiously supports” the Pitts bill, said Dr. Kim A. Williams, director of nuclear cardiology at the University of Chicago and cochair of the ACC's Cardiovascular Imaging Collaborative, at a briefing with reporters. It's not clear how the cuts could be eliminated without causing reductions in other areas, he said. Rep. Carolyn McCarthy (D-N.Y.) has introduced a bill that would repeal the cuts (H.R. 5238).
Call to Action on Risk Factors
The American Heart Association and the American Diabetes Association have issued a call to action to assess patients for their global risk of cardiovascular disease and diabetes. The groups cowrote a document published in both Circulation and Diabetes Care in part to dispel the notion that there is disagreement between them about the need to assess patients for risk factors such as prediabetes, hypertension, dyslipidemia, obesity, and smoking. The debate between the groups has been specifically about the clinical utility of the term “metabolic syndrome,” not about the overall need to screen patients' risk for cardiovascular disease (CVD), they said. “We are concerned that the presumed dispute will lead to a reduction in the favorable trend of many aspects of CVD risk factor reduction,” said AHA president Dr. Robert H. Eckel and ADA president Dr. Robert Rizza, along with science advisers Richard Kahn, Ph.D., of the ADA and Dr. Rose Marie Robertson of the AHA. Risk assessment and adherence to national guidelines remains “woefully suboptimal,” they said.
Postmarketing Study Failure
The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. Among the findings: that the FDA can't easily identify if the studies are progressing or what stage they are in, and that monitoring postmarketing studies “is not a top priority at FDA.” The OIG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drug makers are required to submit annual status reports. The OIG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The OIG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drug makers. In response, the FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.
Supplement Side Effects
Dietary supplement makers and producers of over-the-counter drugs would be required to report serious adverse events to the FDA within 15 business days, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3456), currently pending in the U.S. Senate. The bill was introduced by strange bedfellows: Sen. Orrin Hatch (R-Utah), who crafted the 1994 Dietary Supplement Health and Education Act (DSHEA), which is widely seen as a loophole for the products, along with two frequent critics of DSHEA: Sen. Tom Harkin (D-Iowa) and Sen. Richard Durbin (D-Ill.). The proposal also has the backing of consumer advocates such as Consumer Reports and the Center for Science in the Public Interest, and of several industry groups. The bill has been reported out of the Senate Health, Education, Labor, and Pension Committee and next will go before the full Senate.