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Biomedical subjects

J S Bailes

Publications and source records attributed to J S Bailes.

At least 19 recordsLinked to original sources

Clinical trials: are they a good buy?

PURPOSE: Concern that clinical trials may be too costly has been used to justify traditionally restrictive insurer policies regarding clinical trials. Additionally, fear of insurer reimbursement denial can be a significant barrier to clinical trial participation. In this study, we reviewed the empirical data on costs of clinical trials versus standard care and summarized the current status of policy initiatives related to clinical trial insurance reimbursement. METHODS: Electronic and print data sources were searched for studies on the costs of oncology clinical trials. Information on policy initiatives for clinical trial reimbursement was obtained from the American Society of Clinical Oncology, the American Society of Hematology, and the Coalition of National Cancer Cooperative Groups and from searches of World Wide Web sites. RESULTS: Five pilot studies provided information for 377 patients on phase II/III clinical trials matched with controls on standard care. Cost estimates ranged from 10% lower to 23% higher costs/charges for clinical trials in comparison to standard medical care. Medicare, 14 states, and several private insurers now cover the costs of patient care in "qualifying" clinical trials. CONCLUSION: Findings from small pilot studies suggest that phase II and III clinical trials result in at most modest increases in cost over standard treatment costs. Also, an increasing number of policy makers have decided to support clinical trial reimbursement initiatives. It is hoped that economic data from large observational studies will facilitate widespread and permanent decisions that support reimbursement for phase I, II, and III clinical trial participation.

Clinical Trials as Topic↗

Health-Care Financing Administration's proposed regulations to implement Stark II.

The Health Care Financing Administration published its proposed regulations to implement the 1993 amendments to the Stark law in the Federal Register on January 9, 1998. Several provisions are of interest to oncologists: The rental of infusion pumps to patients; how "physically present in the office" is defined; discounts on drugs; and compensation in a group practice. The details are discussed in this article.

Centers for Medicare and Medicaid Services, U.S.↗

Health care economics of cancer in the elderly.

Changing economic circumstances have brought increased pressure to bear on the traditional revenue sources of oncologists. Practice standards and settings are being challenged to generate cost savings both for third-party payers and for oncology practices. Add to this the growing number of patients older than 65 years, and particularly older than 85 years, and the profession is facing a forced reconsideration of its approach to patient treatment. The current and future training of oncologists needs to incorporate both a multidisciplinary approach of cancer subspecialties and an enhanced ability to evaluate the use and cost-effectiveness of new therapies, second-line and third-line therapies, and palliative treatments.

Aged↗

Medicare changes in the budget bill.

The 1997 federal budget bill contains several significant changes for the Medicare program. Of these changes, revamping of the Medicare capitation program probably has the potential for the greatest impact. This article explains how capitation payments will change under the new system. It also details key changes in Medicare payments to physicians and payments to hospital outpatient departments, rehabilitation hospitals, home healthcare providers, and nursing homes. Finally, several new benefits included in the budget bill are described.

Direct Service Costs↗

The economics of cancer care.

Considerable attention has been paid to the high cost of cancer care. These medical services are expensive, accounting for 10% of total health care expenditures. Factors contributing to high costs include (1) the likelihood that anticancer treatments will lead to costly medical complications: (2) intensive research and development necessary to ensure rapid introduction of a broad array of treatment options; and (3) specialized facilities required for delivery of care. Such efforts as rationing of care and utilizing practice guidelines have been ineffective in controlling costs. To realize savings, we must develop new therapies with sufficient specificity so that anticancer interventions do not impair the patient's general health.

Health Care Costs↗

Cost aspects of palliative cancer care.

Increasing concern is evident about the cost of palliative cancer care, a concern stemming from both government interest in cost containment and the growing nongovernment use of payment rates that are fixed in advance. In general, data on the cost-effectiveness of palliative cancer care are mixed; some types of palliative care appear to increase costs, while other forms may reduce overall costs of treatment. Pain management, however, is an area that seems to present significant opportunity for cost savings in palliative care if oral medications are used instead of high-technology modalities.

Antineoplastic Agents↗

Current issues in oncology reimbursement.

The reimbursement policies of Medicare, Medicaid, and private insurers can have a major impact on the ability of oncologists to deliver care to their patients. This article explores current issues of particular interest to oncologists, including coverage of off-label drug uses, reimbursement for drugs used in clinical trials and for costs of care for patients in trials, the effect of DRGs on the introduction of new technologies, attempts by Medicare to develop a fixed-price payment system for hospital outpatient department services, new methodologies for determining fee schedules for physician services, bundling versus separate payments for chemotherapy administration, and whether payments for drugs administered by physicians should be based on the average whole-sale price (AWP) or some other methodology.

Fee-for-Service Plans↗

Use and coverage of novel cancer agents in managed care.

Cancer is unique because its management depends on novel therapies to a greater extent than most other diseases. State-of-the-art care requires access to physicians and facilities that specialize in cancer treatment; however, such access may be blocked by the gatekeeper in the managed care setting. One possible solution to this problem lies in the use of specialists to determine access to tertiary care facilities. Managed care facilities also may limit access to the comprehensive drug therapy required by cancer patients, often by restricting off-label drug uses. To solve this problem, criteria should be developed for the use of novel cancer therapies, such as whether off-label uses are supported by major medical compendia or peer-reviewed medical literature. Finally, managed care organizations may deny coverage of state-of-the-art care associated with clinical trials, which may limit the patient's ability to participate in clinical trials. Managed care organizations should cover such costs if they meet certain criteria, such as absence of clearly superior treatment. To provide comprehensive, state-of-the-art care for cancer patients, managed care organizations and oncologists must collaborate and find solutions to their mutual problems.

Adult↗

Reimbursement: current status and future outlook.

Third-party payer reimbursement policies have undergone significant changes in recent years and will probably continue to do so as the nation's health care system is reformed. These changes will have important implications for oncologists, similar to those that have arisen as a result of Medicare's payment system changing from one of "reasonable charges" to a fixed-fee schedule. The likely growth of managed competition as part of health care reform may prove to be disadvantageous to the oncologist without laws or rules guaranteeing cancer patients the right to treatment by a specialist and to tertiary care. Other areas of importance that will probably be affected include reimbursement of patient care costs associated with clinical trials and of drug costs when the drug is used for off-label indications.

Antineoplastic Agents↗

Payment and coverage issues affecting medical oncology.

Medical oncologists continue to face significant issues in obtaining full payment for and coverage of their services by third-party payers. A number of issues raised by the Medicare fee schedule have, however, been at least partially resolved in a favorable manner. There continue to be problems in coverage of off-label drug uses and services associated with clinical trials. The impending reform of the health care system may improve the situation or it may give rise to further difficulties.

Ambulatory Care↗

Reimbursement for oral anticancer drugs.

Current policies regarding reimbursement for oral anticancer drugs are discussed. Several legislative options that might expand such coverage are reviewed.

Administration, Oral↗