New Certification for Diabetes Care
The American Diabetes Association and the Joint Commission on Certification of Healthcare Organizations are developing what they say is the first nationwide certification for inpatient diabetes care. To attain the certification, organizations will need to participate in an on-site review to assess compliance with national standards and adherence to guidelines for diabetes management. The review also will look at the organization's performance measurement and improvement programs, quality of physicians and other clinicians, patient self-management programs, leadership support, and the information technology that are being used to monitor patient care. “The collaboration between the ADA and the Joint Commission will help standardize the care provided for all diabetic patients in all inpatient departments in a hospital,” Jean Range, executive director for disease-specific care certification at the commission, said in a statement. “Through systematic monitoring of all diabetic patients, outcomes can be improved. This will lead to a better quality of life for diabetic patients and position certified organizations for success in pay-for-performance programs.” The commission plans to convene an expert panel that will develop performance measures for inpatient diabetes care.
Iacocca Funds Diabetes Cure Search
The Iacocca Foundation, a project of former Chrysler CEO Lee Iacocca, is giving $12 million to research projects aimed at finding a cure for diabetes. Two projects to be funded by the grants are clinical trials by Dr. David Nathan and his colleagues at Massachusetts General Hospital, Boston, and by Dr. Jerry Nadler at the University of Virginia, Charlottesville; both trials attempt to stop the autoimmune reaction that takes place in type 1 diabetes. Another project included in the funding, this one at the Harvard School of Public Health in Boston, looks at the link between childhood obesity and the development of type 2 diabetes. “These projects hold tremendous promise in the quest to find a cure for this terrible disease,” Mr. Iacocca said in a statement. “Medical research is costly, and providing the funding necessary to keep these and other diabetes research projects moving forward is and always will be our mission.” The foundation was established in 1984 in honor of Mr. Iacocca's late wife, Mary, who died of complications of type 1 diabetes. It has given more than $23 million to diabetes research.
Regulating Nanotechnology
The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.
The agency will kick off its efforts with a public meeting scheduled for October 10 and will report its initial findings to the acting FDA commissioner within 9 months.
Fix SGR, Delay Imaging Cuts
Several members of Congress attempted to head off the CMS's proposals just before the August congressional recess. A bill (H.R. 5866) by Rep. Michael Burgess (R-Tex.) would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be 5.1% (see p. 6). Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” Mike Hogan, the Washington representative for the Society of Thoracic Surgeons, said he believes there is a congressional consensus for a permanent physician payment fix, but added, “at the end of the day with the elections looming, I think there's a lot of possibility for things to go wrong.” Rep. Burgess' bill also would delay by 1 year proposed imaging payment cuts, and require the Institute of Medicine to study whether imaging saves money.
The American Medical Association called the Medicare Physician Payment Reform Bill and Quality Improvement Act of 2006 an “important step toward replacing the flawed Medicare physician payment formula.” Rep. Burgess' bill is the third in the House to seek to delay or repeal the imaging fee cuts. Rep. Joseph Pitts (R-Pa.) has called for a 2-year delay in H.R. 5704. A similar bill was recently introduced in the Senate by Gordon Smith (R-Ore.) and Jay Rockefeller (D-W.Va.).
Unique IDs for Medical Devices?
The FDA is seeking comments on how to create unique identifiers for medical devices and whether such a system might reduce errors or help improve adverse event reporting and make withdrawals easier. The agency has held several meetings with interested parties, but still has not proposed any requirements—even though in a final rule in 2004 it said it will require all pharmaceuticals to include identifying bar codes. According to an FDA statement, any input the agency receives during the 90-day comment period, which ends in early November, will help “determine what next steps the agency should take” on devices. An identifier might include the manufacturer, make and model, size and length, software version, lot number, and expiration date.