Trials produce information of value to future patients, and frequently benefit the people enrolled in them.
The undersigned cancer patient, provider and research organizations are pleased to have the opportunity to comment on the reconsideration of the Medicare clinical trials policy. Most of us have a longstanding involvement in clinical trials, ranging from advocacy for adequate reimbursement for clinical trials to engagement in trials design initiatives to ongoing education and outreach to increase patient participation in cancer clinical trials.
We write to urge that the reconsideration of the clinical trials policy be viewed as an opportunity for refinement of the policy and its implementation and not a chance to impose limits on the current scope of coverage.
Benefits of National Coverage Decision Clinical trials are an important option for cancer patients, particularly those with limited treatment choices. The National Coverage Decision has made clinical trials more accessible to patients. For example, one of the large cancer cooperative groups has undertaken an analysis of participation by patients age 65 or older in the group's trials and has observed an increase in participation by seniors since the National Coverage Decision.
This improvement, while important, is clearly insufficient, and cancer organizations are engaged in efforts to address obstacles, other than reimbursement issues, that hinder seniors' participation in clinical trials.
However, any retrenchment in the Medicare coverage policy would likely threaten the progress in boosting senior participation in trials that has been made to date.
Definition of "Routine" Costs We understand that one of the challenges in implementing the clinical trials policy has been the lack of a reliable and consistent definition of "routine costs" in clinical trials.
Uncertainty about what will be considered a routine cost contributes to a compliance burden for trial sponsors and participating physicians and can cause concerns among Medicare beneficiaries about reimbursement for the care they receive in a trial. Prior to the National Coverage Policy, seniors reported that uncertainty about reimbursement contributed to their reluctance to participate in trials.
A lack of clarity about routine care costs — and resulting confusion among trial sponsors — may have a similar effect on participation. Beneficiaries in Medicare Managed Care Plans One population of seniors that has not benefited from the clinical trials coverage policy is Medicare beneficiaries enrolled in Medicare managed care plans.
Managed care enrollees have reported since implementation of the coverage policy that they cannot participate in trials because they are subject to coinsurance requirements for expenses of the trial.
This population of beneficiaries do not ordinarily purchase supplemental coverage policies. Because these beneficiaries do not have supplemental coverage and cannot afford to pay out-of-pocket for coinsurance amounts, they forego clinical trials participation.
The cancer cooperative group study identified seniors without supplemental insurance policies — most likely managed care enrollees — as a group that participates in trials at a less robust rate than seniors overall. We urge CMS to adjust payments to managed care plans to reflect the costs that have been associated with the National Coverage Decision on routine patient care costs in clinical trials.
If efforts to boost enrollment in managed care plans are successful, this will become an even more serious problem.
Therefore, we urge immediate action to address it. We appreciate the opportunity to comment on the reconsideration of the Medicare clinical trials policy. We strongly urge that this process be utilized to improve the implementation of the policy and not to limit or restrict the current policy.the proposed decision memo on NGS for Medicare beneficiaries with advanced cancer or related limited to participants in National Cancer Institute (NCI) clinical trials.
We understand that these tests have a written analysis plan; and address the same questions in the criteria for FDA-cleared or -approved tests designed to compare.
to participate in trials for fear they would lose their Medicare coverage Assuring Medicare beneficiaries that their routine costs will be covered is expected to increase their participation in clinical trials.
Cancer care cost analyses are usually performed in 3 phases to reflect clinical and cost- related dynamics, including an initial phase (time following diagnosis, usually up to 1 year), a. The Center for Medicare and Medicaid Services (CMS) requires a clinical trial identifier (NCT#) be reported on all billing claims for items/ services related to a qualifying clinical trial.
If your study will bill routine costs to Medicare or any other insurer, the study must be registered on ashio-midori.com to obtain the NCT#.
In this study, we used Medicare claims data to examine changes in the management of prostate cancer in a nationally representative 5% sample of Medicare beneficiaries and to extend this analysis to patients diagnosed through Cancer Research and Clinical Trials The Crozer-Keystone Cancer Centers have an active Cancer Research Program, which has grown steadily over time.
Clinical trials are state-of-the-art research studies using medicines, radiation therapy, surgery and/or other treatments.
CLININCAL RESEARCH BILLING WITH PATIENT FINANCIAL SERVICES Clinical Trials - Types of Clinical Trials complications arising from participation in all clinical trials. All other Medicare rules apply.” Source: Clinical Trial Policy. 11 provided to Medicare beneficiaries and to individuals enrolled in private insurance. Examples. The Medicare Coverage Analysis (MCA) is a federally mandated process required for all clinical research studies anticipating enrolling Medicare beneficiaries. This analysis determines and documents a study’s eligibility for Medicare coverage and reviews the clinical events specified in the protocol to determine what may be appropriate. The University of Pittsburgh Cancer Institute study concluded that because of the significant personal expense necessitated by the CMS requirement to return to FFS Medicare, the disparity between eligibility of Medicare beneficiaries for clinical trials and clinical trial representation is likely related. 3 “Under-representation affects our.