Originally Published IVD Technology June 2001
Industry News
Congress tackles Medicare access to diagnostic tests
Legislation
recently introduced in Congress is aimed at ensuring that 39 million elderly
and disabled patients on Medicare have access to the latest laboratory tests
to detect and monitor disease. Proponents say that the Medicare Patient Access
to Preventive and Diagnostic Tests Act of 2001 would take considerable steps
toward improving the current Medicare payment policy for outpatient clinical
laboratory tests.
The bill calls for establishing an open, transparent, and rational public process for the adoption of new tests; developing sound methodologies for setting fair and appropriate payment levels for new tests; implementing a single, national fee schedule for new and current tests that provides for regular updates; and providing a mechanism for stakeholders to challenge fee-schedule decisions.
"This bill gives seniors much-needed access to critical laboratory tests that could identify diseases and disorders earlier," says Representative Jennifer Dunn (R–WA), who introduced the bill. "Right now, many seniors are not receiving the care they need because of a complex and antiquated process for assigning billing codes and setting reimbursement rates."
The new legislation was crafted based on findings from a study conducted by the National Institute of Medicine (Washington, DC) to assess current Medicare payment policy. The study, entitled "Medicare Laboratory Payment Policy Now and In the Future," found that existing mechanisms for keeping payments up to date are inadequate, especially the process for integrating new technologies into the payment system. The report, issued in January 2001, said that such problems "are likely to become increasingly important with the anticipated changes in laboratory technology and medical practice."
The bill has received strong support from a coalition of patient advocacy groups and clinical laboratory professional and trade associations, including AdvaMed (Washington, DC) and the American Clinical Laboratory Association (also Washington, DC). "Breakthroughs such as the sequencing of the human genome are spurring a revolution in diagnostic testing," says Charles M. Fleischman, president of Digene Corp. (Gaithersburg, MD). "We must address problems in Medicare that create barriers to the adoption of new tests.
"These innovative diagnostic tests are vital to the health of Medicare patients and the program itself because they help save lives and reduce healthcare costs by detecting diseases earlier when they are more treatable," says Fleischman. "However, coding and payment delays, as well as inconsistent and inadequate reimbursement for these tests, discourages their use in laboratories and hinders research and development into future tests."
The bill has been
forwarded to the House Ways and Means Committee and the House Energy and Commerce
Committee. Industry sources are hopeful that it will be included in a package
of targeted Medicare reforms expected to come up for a vote this fall.—Susan
Wallace
|
Notable
Roche Diagnostics (Mannheim, Germany) has issued a Class II recall of its Accu-Chek Advantage blood glucose meters and its Accu-Chek Voicemate glucose monitoring systems for the visually impaired because of software problems. The defect in the Accu-Chek Advantage meter causes the device's memory to store erroneous values under specific circumstances. If the user performs a test when the meter's internal clock registers from 12:00 a.m. to 12:10 a.m. on the day that the meter believes is the first of a seven-day cycle, the test result can be incorrect. The same software problem also causes the Accu-Chek Voicemate system to orally report erroneous values taken from the meter's memory. According
to FDA, a Class II recall "is a situation in which use of or exposure
to a violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote." The recalls of Roche's Accu-Chek Advantage and
Accu-Chek Voicemate were reported in FDA's Recalls & Court Actions
report dated April 4, 2001. Roche has recalled a total of 2 million units
distributed worldwide. ChromaVision
Medical Systems Inc. (San Juan Capistrano, CA) has signed an agreement
with Antibodies Inc. (Davis, CA), a contract manufacturer of diagnostic
kits, to market customized reagents and antibody kits together with ChromaVision's
automated cellular imaging system (ACIS). The two companies will collaborate
to develop products that complement current and future ACIS applications
in order to offer a complete slide-based testing system to healthcare
providers. The agreement calls for Antibodies Inc. to manufacture reagents
and kits that ChromaVision will market with its ACIS under its own label.
Beckman Coulter (Fullerton, CA), recently announced the formation of three divisions aligned along the "biomedical testing continuum," a term that the company uses to describe the range of laboratory testing that ultimately has an impact on patient care. The company also named presidents for each division. The new divisions and their respective presidents are life sciences research, led by George E. Bers, former vice president of bioresearch at Beckman Coulter; specialty testing, led by Edgar E. Vivanco, former senior vice president of diagnostic development, corporate manufacturing and quality; and clinical diagnostics, led by Albert R. Ziegler, former senior vice president of diagnostics commercial operations. |
Photo By David W. Hamilton/Image Bank
Copyright ©2001 IVD Technology
