Medicare Compliance & Reimbursement
Agencies Combine Forces To Combat Cancer
A first-time collaboration between different Department of Health and Human Services agencies may soon send cancer therapy development into warp speed.
The Centers for Medicare & Medicaid Services joined the Food and Drug Administration, the National Cancer Institute and the National Institutes of Health to form the new Oncology Biomarker Qualification Initiative, the FDA announced Feb. 14. The agencies hope the initiative will improve cancer therapy innovations and patient outcomes through further development, evaluation and validation of biomarkers--biologic indicators of disease or therapeutic effects that providers can measure through dynamic image testing, as well as blood, tissue and biologic sample testing.
"We are excited about this effort to speed the development and delivery of new cancer treatments for patients," says HHS Secretary Mike Leavitt. "By bringing together the scientific, regulatory and delivery expertise of [these] agencies, we can bring targeted, more personalized cancer diagnostics, treatments and preventions to patients more rapidly."
Biomarkers 'Set The Bar' For Research Trials
Specifically, the OBQI's mission is to validate promising biomarkers so that researchers can use them as standard, reliable evaluation benchmarks. With these biomarkers to work from, researchers will be able to streamline and improve clinical trials and drug development, the FDA notes. Drug coverage and safety for cancer patients would also see notable improvement, the FDA adds.
"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," points out NCI Deputy Director Anna D. Barker. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."
The OBQI's first evidence-based biomarker study will attempt to validate and standardize the use of Fluorodeoxyglucose--Positron Emission Tomography scanning, announces the FDA. The OBQI will determine whether FDG-PET can reliably predict tumor response by working with researchers who are using FDG-PET imaging technology in patient treatment trials for non-Hodgkin's lymphoma. The results will help the FDA and CMS work with drug developers through a common understanding of these types of assessments, the FDA maintains.
"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," notes CMS Administrator Mark McClellan. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."
CMS To Collect PET Scan Data From National Repository
The OBQI announcement comes on the heels of an agreement between CMS and the National Oncologic PET Registry--an Internet-based, audited data repository that collects and reports on PET data from benes and providers.
CMS will work with the NOPR to collect nationwide PET scan data that will enhance cancer treatment innovations and improve treatment availability for cancer patients, CMS announced Feb. 10.
"The NOPR affords oncologists and nuclear medicine physicians a unique opportunity to make PET available to Medicare beneficiaries and to improve our understanding of the role of PET in oncology practice," says NOPR Working Group co-chair Barry Siegel. In January 2005, CMS expanded Medicare coverage of PET scans for brain, cervical, ovarian, pancreatic, small cell lung, testicular and other cancers.
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