The available evidence suggests that Medicare already pays for a large proportion of routine patient care in such trials, including both costs for which no reimbursement is sought, and claims that are submitted and rejected.
The committee recognizes that implementation of this recommendation will necessarily take some time. With a clear statement of reimbursement policy, such claims should pose difficulties no different from those arising in the administration of coverage and reimbursement rules for claims for care outside of trials.
It could also fund other costs as well, under the exceptions procedure described in the preceding paragraph. First, HCFA should reimburse for care in selected trials that would not otherwise qualify, or reimburse at a higher rate than would otherwise be allowed for investigational interventions that are more expensive than the standard treatment.
Finally, although not a requirement of implementing a new policy, the committee recommends prompt completion of a national clinical trials registry. Short abstract A Clinton administration Executive Memorandum authorized Medicare payment for routine costs associated with clinical trials and recognized the role of clinical trials in patient care.
Clinton issues order providing expanded coverage for elderly, disabled taking part in testing for new drugs or medical treatments. Until a registry is in operation, reimbursement claims for interventions associated with a clinical trial should be denoted on the form, in a manner HCFA specifies. J Clin Oncol The committee recommends limiting reimbursement to trials that have been reviewed and accepted by all relevant institutional review boards IRBs.
In contrast, the introduction of new procedures is not governed by any regulatory authority. If it were concluded that converting this limited registry into an inclusive national registry would be needlessly cumbersome, the creation of a separate comprehensive registry, serving objectives beyond those of NIH, or even of HCFA, should be explored.
The White House did not say what the cost to Medicare would be. On the contrary, HCFA should encourage such trials and even extend reimbursement in a limited number of specifically approved exceptional cases.
Centers for Medicare and Medicaid Services: Medicare should continue its current practice of reimbursing costs of treating conditions that result as unintended consequences complications of clinical trials. Medicare reimbursement should not hinge on a judgment by HCFA about the quality of the trial.
In all cases, HCFA should provide clear guidance on how the recommended reimbursement policies should be implemented by providers and the entities that process Medicare claims.
Under the current interpretation of Medicare reimbursement rules, the committee believes that surgeons and others performing surgical or other procedures in trials might not be eligible to be reimbursed for those services.Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria.
This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development. Jun 08, · Medicare to Cover Care in Clinical Trials.
Health: Clinton issues order providing expanded coverage for elderly, disabled taking part in testing for new drugs or medical treatments. June 08, | From Associated Press. are Medicare beneficiaries. Among cancer patients, the White House said that 63% are age 65 or older--the.
Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer with a potentially actionable genomic variant.
Pursuant to a congressional request, GAO determined the potential effect of the proposed Medical Cancer Clinical Trial Coverage Act by estimating the current rate at which Medicare carriers deny reimbursements for routine patient care costs when beneficiaries are enrolled in cancer clinical mint-body.com noted that: (1) its survey method did not allow it to give a precise national estimate of the.
3 Recommendations for Medicare Clinical Trial Reimbursement. ). Clearly, the proportion of Medicare beneficiaries in clinical trials is quite small.
The available evidence suggests that Medicare already pays for a large proportion of routine patient care in such trials, including both costs for which no reimbursement is sought, and.Download