Extending Medicare Reimbursement in Clinical Trials (2000) / Chapter Skim
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30 2 Paying for Patient Care in Clinical Trials The lion's share of funding to carry out clinical trials comes from two main sources: the federal government and private industry. In general, trial budgets cover the costs of setting up and managing the trial, recruiting participants, and collecting and analyzing data.
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 31 Clearly, official policy and common practice and understanding do not always match in reimbursement for patient care costs in clinical trials. In this chapter, we have pieced together as complete a picture as possible of how, and the extent to which, the costs of treating people in clinical trials are actually covered.
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32 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS tion was instrumental in initiating a trial of high-dose chemotherapy with bone marrow transplant rescue for women with advanced breast cancer)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 33 By the time of the hearing, HCFA had already changed its policy to allow reimbursement for patients in certain trials involving investigational devices (see below) , but not for trials of other types of interventions.
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34 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS porting the routine patient care costs associated with these trials. The result was an attempt to determine whether it was feasible to extend Medicare coverage to at least some investigational devices while maintaining safe medical care.
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 35 TABLE 2-1. Criteria for Categorization of Investigational Devicesa Under HCFA/FDA Interagency Agreement Category A: Experimental Subcategory 1 Class III devicesb of a type for which no marketing application has been approved for any indication or use 2 Class III devices that would otherwise be in category B but have undergone significant modification for a new indication or use Category B: Nonexperimental/Investigational Subcategory 1 Devices, regardless of classification, under investigation to establish substantial equivalence to a predicate device (one that is or could be legally marketed)
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36 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Coverage with Conditions In certain cases, HCFA has concluded that investigational treatments do meet the test of being "reasonable and necessary" when provided according to certain specifications. An early example of this, starting in 1986, is coverage of the costs of heart transplants only in specific "centers of excellence" according to an approved protocol, and only for patients meeting specified criteria (Evans, 1992)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 37 created the independent Prospective Payment Assessment Commission (ProPAC) to advise HCFA about hospital payment under Medicare, but also to "identify medically appropriate patterns of health resources use" (42US Code, Sec.
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38 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS costs for claims that are denied (or never filed) are eventually paid.
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 39 sought reimbursement for enrolled patients. (They did not request or receive billing or accounts data for specific trials.)
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40 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS tional, whether or not formally labeled as clinical research. Thus, in advanced melanoma trials, because no standard exists, oncologists generally classify some patient care costs as "routine" and seek reimbursement from insurers.
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 41 General Clinical Research Centers GCRCs are NIH-funded hospital beds set aside specifically for research, which can be used by investigators supported by the NIH, as well as those funded by other public and private agencies. Most GCRC studies are early (phase 1)
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42 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS payment is $750 per patient versus $2,500 per patient for industry-sponsored trials. Pharmaceutical sponsors usually cover costs for all procedures, both routine and investigational, required by the protocol.
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 43 unusual diagnosis. These cases might be investigated and the fact of a clinical trial uncovered.
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44 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS The Medical Directors believe they are generally more aware of patients treated under IDEs than in other types of clinical trials because of the specific payment rules for device trials. In practice, some virtually never deny a reimbursement claim for a category B device (except in the case of explicit HCFA guidance against reimbursement)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 45 DoD/NCI Agreement In January 1996, the Department of Defense (DoD) began a 3-year demonstration project to pay medical costs for cancer patients who enrolled in phase 2 or 3 NCI-sponsored cancer treatment trials (DoD/NCI, 1996)
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46 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS trials at its own facilities (exceptions could still be made, e.g., in the case of a rare tumor for which no trials are ongoing at VA facilities)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 47 State Laws Several states have enacted laws that require private insurers (i.e., not HCFA) to reimburse the costs of routine patient care in certain types of clinical trials.
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48 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS the covered costs to be limited to those covered by Medicare under standard treatment conditions (i.e., outside of clinical trials)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 49 laboratory tests, X-rays, psychiatric hospital, inpatient rehabilitation, long-term care hospitalization, and other services and supplies are covered. Part A does not cover physician services, which are covered under Part B
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50 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Beneficiaries pay an annual deductible, monthly premiums, and coinsurance for services (usually 20 percent of the Medicare allowed charges)
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PAYING FOR PATIENT CARE IN CLINICAL TRIALS 51 tract enrollees, most managed care plans offer benefits not covered under fee-forservice Medicare (e.g., coverage of most Medicare cost-sharing, expanded preventive care, prescription drugs, eyeglasses, dental care, or hearing aids)
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52 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Medicare Administration HCFA, within DHHS, has primary responsibility for Medicare, including formulation of reimbursement and coverage policy and guidelines, but other entities have specific roles to play. The Social Security Administration determines an individual's initial Medicare entitlement and maintains the Medicare master benficiary record.
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