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www.imos-illinois.com Spring 2007 |
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Marci Cali Gaining knowledge through clinical trial research is at the core of innovations in patient care, bringing new diagnostic tests and treatments that improve health and prolong lives. Today, clinical trial involvement is growing on the community level both as a way to be at the forefront of advances in patient care and as a means of providing access to state-of-the-art treatment to patients that remain under a practice's care. On many occasions I have been asked about resources for clinical trials in the physician practice. Most times, the conversation is tied to the lack of reimbursement and costs for treatment that can no longer be absorbed by the practice and/or expenses that far exceed what the patient can pay for out-of-pocket. On the other side of the coin, I am approached by pharmaceutical associates in clinical development who need more patients than ever before to participate in the trials that evaluate new treatments. Although patients rely heavily on the advice of their oncologist, it is a colossal decision for patients to choose to enter a clinical trial. Clearly, resources are needed to help meet the needs of both parties. Over the past 15 years, the amount of research and number of trials have increased dramatically as drug and medical device companies develop and bring more treatments to the public. Organizations such as the American Society of Clinical Oncology (ASCO) are making a commitment to educate and facilitate the participation by community oncologists in clinical trials. This commitment includes offering programs and meetings on ways to become involved in clinical trials and recognizes the doctors in the community who participate in them. Through those recognized physicians participating in clinical trials, ASCO hopes to reach a much broader constituency and spread the word about the importance of clinical trial participation. Oncology practices that are interested in participating in clinical trials have an array of resources to help them and their patients find active clinical trial centers throughout the states. The following is a resource list to help you: |
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The Centers for Medicare and Medicaid Services (CMS) announced April 3, 2007, detailed specifications for the 74 measures included in the 2007 Physician Quality Reporting Initiative (PQRI). Click here to see the measure specifications document and other programmatic information. The following specific cancer-related quality measures are included:
The PQRI will begin July 1, 2007. This initiative, which was created through the Tax Relief and Health Care Act of 2006 (TRHCA), is a voluntary program that will provide a financial incentive to physicians and other eligible professionals who successfully report quality information related to services provided under the Medicare Physician Fee Schedule between July 1 and December 31, 2007. Key aspects of the program include:
Medicare’s latest quarterly update of Part B average sales prices (ASPs) (second quarter 2007) is available. Effective April 2007 here are the latest ASPs for selected Part B oncology drugs:
“Drug counterfeiters use a wide array of techniques, including diluting or re-labeling drugs, manufacturing fake drugs, or selling ‘compromised drugs,’ ” according to presenter Rolando DeCardenas, vice president of pharmaceutical distribution for US Oncology, who spoke at ACCC's Annual National Meeting in March. Unfortunately, many of these drugs are hard to detect, because the more sophisticated counterfeiters use equipment that makes pills and bottles appear remarkably authentic. These drugs are then sold at steep discounts to secondary wholesalers. What can an oncology practice do to safeguard providers and patients? According to DeCardenas, the answer is two-fold: 1) partner with a distributor that has implemented a drug pedigree system that can trace and authenticate each step of a drug’s journey through the supply chain and/or 2) purchase drugs from a Verified-Accredited Wholesale Distributor. The National Association of Boards of Pharmacy’s Verified-Accredited Wholesale Distributor certification ensures that a wholesaler has appropriate licensure, internal procedures, and employee background checks in place.
Although more than 40,000 patients worldwide have been treated with proton therapy, much of the experience has been in research facilities suitable for treating only a few rare tumors. Limited capacity for proton therapy in clinically dedicated facilities has prevented large-scale trials of proton therapy, but available data suggest that improved radiation dose distribution will translate into clinical advantages over other forms of radiation therapy in most cancers, where outcomes with conventional radiation therapy leave room for improvement. The more radiation dose distributions are restricted to the actual targets, the more demanding the quality assurance measures. The treatment process with proton therapy requires onsite high-resolution imaging to define the three-dimensional target volume, highly sophisticated computerized treatment planning software, specialized patient immobilization devices, strategies to decrease movement of organs within the body during treatment, and submillimeter precision in patient positioning and beam guidance. The added precision requires additional physics and engineering personnel for technical support. The cost of proton therapy is somewhat more than the cost of conventional radiation therapy, related to more expensive equipment and technical personnel required for treatment and equipment maintenance. With respect to capital cost, the price for a proton therapy facility that could treat 150 patients a day could be up to 10 times the cost of a conventional therapy facility with similar capacity. Proton therapy facilities are built to last a minimum of 30 years, however, while conventional linear accelerators require replacement after 7 to 10 years. Proton facilities also carry somewhat higher operational costs related to the level of expertise required for treatment planning, quality assurance, machine operation and maintenance. Despite the higher initial costs of proton therapy, if proton therapy fulfills the promise of decreasing recurrence rates and toxicity rates, then its long-term cost may actually prove less than conventional radiation therapy. Medicare and most national health insurance companies provide coverage for their policyholders.
Biomarkers, such as proteins or chemicals that flag the presence of disease or measure the effects of drug treatments, have been held up as promising tools in cancer care. But a new report from the Institute of Medicine (IOM) says significant challenges, including a patchwork of standards for clinical use of cancer biomarkers, have slowed progress. The report, "Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment," recommends that federal authorities and other stakeholders take a coordinated approach to research and development (R&D) in this area. Research sponsors should focus support on projects to develop indicators of cell communication pathways that are involved in many kinds of cancer and other diseases, so that the resulting biomarkers would have the broadest possible application, the report says. The number of false results generated by widely used biomarker-based tests for breast cancer underscores the need for uniform standards to validate tests and for greater regulatory oversight of tests once they reach the market. No federal agency now takes responsibility for ensuring the clinical validity or usefulness of biomarkers. Copies of "Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment" are available from the National Academies Press; tel. 202.334.3313 or 1.800.624.6242 or at http://www.nap.edu. The cost of the report is $42 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy.
The Association of Community Cancer Centers (ACCC) will present its 24th National Oncology Economics Conference on October 3-6, 2007, in Dallas, Tex. Every paying Society/ACCC-member registrant may bring a colleague at half price! The offer does not apply to industry representatives and cannot be used in conjunction with any other promotional coupons or discounts. ACCC's National Oncology Economics Conference is the perfect opportunity for you and other members of your practice to learn about reimbursement trends and their effect on your bottom line, strategies for a more efficient work environment, implementing and paying for new technologies and treatments, and staffing issues. Your entire cancer care team (physicians, nurses, administrator, and billers/coders) will strengthen their skills and network with their colleagues. CME, CNE, and ACPE credits are available through the University of Kentucky Colleges of Medicine, Nursing, and Pharmacy.
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© Copyright 2007 Association of Community Cancer Centers. All Rights Reserved |
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