Pharmacy & Therapeutics - June 2008 - (Page 353)

Evaluating and Standardizing Medical Devices continued from page 350 uct use and equivalencies, cost comparisons, and the evaluation of patient outcomes.4 An evidence-based approach enables health care to be informed and tailored by scientific methodology.8 Safety and efficacy are enhanced when clinical practice is guided by well-designed, randomized, controlled, multicenter clinical trials.8 Decisions based upon scientific evidence also increase transparency and potentially reduce bias and conflict of interest.8 However, most facilities do not have the ability to conduct their own analyses, because conventional computer systems lack the ability to track products by specific identification numbers, costs, and outcomes.4 Although some dedicated information systems are designed specifically for medical devices in areas such as cardiology, the enterprise software systems that hospitals generally use do not integrate cost and clinical data needed to determine equivalencies.4 Many facilities maintain a clinical effectiveness database that includes length of stay and morbidity, but the data are not tied to specific products.4 Some manufacturers also obscure data needed for cost comparisons and even include a price disclosure confidentiality clause in their contracts with hospitals.4 An additional problem is that the evidence-based technology assessments that are available are poorly disseminated.8 Several independent medical technology assessment groups in the U.S., as well as abroad, maintain critical analyses of the efficacy and safety of new medical devices. Recently, an initiative was proposed in the U.S. for the formation of a national database of comparative data for prices and quality outcomes for devices in the same category.2,8 The entire medical community—clinicians, patients, administrators, and manufacturers—would also benefit from better access to evidence-based technology assessments like those provided by independent groups such as the Technology Evaluation Center of the Blue Cross–Blue Shield Association (TEC) and the California Technology Assessment Forum–Blue Shield of California Foundation (CTAF).8 In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) evaluates devices according to the same protocol that it applies to drugs.8 A European Cardiac Surgery database also provides clinical outcomes and benchmarking capabilities for medical devices.9 These evidence-based assessments instill confidence in the efficacy of new products and procedures, provide points of differentiation, and influence practice.8,9 Hospital committees are increasingly demanding proof that newer, costlier drugs or medical devices are more effective and efficient than existing products, cause fewer adverse effects, and reduce health care expenses; consequently, postmarketing studies will likely assume greater importance in the future.3 Dr. Nash remarked: The same rigorous evidence-based analysis is now being applied to devices as has been historically done with new drugs. Device manufacturers are going to be increasingly put upon to provide information beyond efficacy, such as cost-effectiveness and cost–benefit information, and clinical data from randomized trials. Previously, devices had to satisfy an analysis only for safety, but now they will be evaluated on the basis of efficacy, efficiency, and effectiveness. The expense of these products has now mandated a more thorough evaluation. Sheri Dodd agreed, noting: Our customers are starting to ask what the value is, even for products at the 510k level. We are starting to generate premarketing and postmarketing clinical evidence that otherwise wouldn’t be required for FDA approval but is for what we are calling ‘market access approval,’ an approval by our purchasing customers. We have evidence-generation strategies for all our products, so we are providing input early rather than having a negative P&T committee review due to insufficient data.” The relatively new field of pharmacoeconomics has also emphasized cost-effectiveness analyses that consider both direct and indirect costs of newer drugs and therapeutic modalities.3 Previously, devices had to satisfy an analysis only for safety, but now they will be evaluated on the basis of efficacy, efficiency, and effectiveness. The expense of these products has now mandated a more thorough evaluation. Current Procedural Terminology (CPT®) Codes And Reimbursement for Medical Devices Reimbursement policies are important because they shape medical practice.1 Because few patients are able to pay for health care directly, third-party payers play an influential role in determining how new medical technology is used.1 Medical device manufacturers depend on insurance reimbursement to create favorable conditions for selling their products.1 Christine Maroulis explained: “With the introduction of a new device, we are often creating entirely new medical procedures that require the establishment of new codes, new coverage policies, and new payment methodologies.” Health care providers and institutions depend on reimbursement to offset the costs of adopting new products and procedures into medical practice.1 Reimbursement policies consequently serve as an influential gatekeeper for new medical technologies and procedures.13 They also have become an area of conflict between the adoption of these new products and procedures and the control of health care and insurance costs.13 The current reimbursement climate presents daunting challenges for health care practitioners and institutions.1 The influence of Medicare’s reimbursement policies is widespread, because they extend to private payers who use these payment rates as a benchmark for setting their own rates.14 Medicare is the largest purchaser of health care services in the U.S., providing health insurance coverage for more than 41 million people and accounting for 20% of all health care spending.14 In the Medicare system, prices are set prospectively by the Centers for Medicare and Medicaid Ser vices (CMS).13,14 Private payers typically pay a certain percentage above the Medicare price, and public programs, such as Medicaid, pay some percentage below it.14 However, the determination of reimbursement policies by Medicare is often delayed. A study by the Lewin Group found that it took the CMS from 15 months to five or more years to add new medical technologies to the Medicare program.1 This Vol. 33 No. 6 • June 2008 • P&T® 353

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.