Mammography and Beyond Developing Technologies for the Early Detection of Breast Cancer (2001) / Chapter Skim
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5 Evaluation and Cost Coverage of New Technologies
5 Evaluation and Cost Coverage of New Technologies
Pages 167-198
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From page 167... ...
Most health economists believe that technology is the single largest driving force behind the long-term rise in health care spending in the United States (Fuchs, 1999; Rettig, 1997~. Because the resources for health care are not infinite, there has been increasing pressure to make evidence-based decisions about the use of medical technology, and as a result, the need for technology assessment has risen.
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From page 168... ...
Coverage decisions determine whether a particular service or product is eligible for reimbursement, whereas the actual rates of reimbursement (the methods and amounts of payment) for covered services and products may vary greatly depending on the specific case, location, insurance carrier, and so on.
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From page 169... ...
with coverage decisions. However, despite its involvement in health technology assessment, the federal government has never really carried out the central technology assessment repository function that was originally envisioned (U.S.
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From page 170... ...
This changed somewhat in 1995 through an interagency agreement between HCFA and FDA, which established coverage and reimbursement for certain devices and related services in clinical trials carried out under FDA-approved investigational device exemptions (IDEs)
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From page 171... ...
Class III is the most stringent regulatory category and includes devices for which safety and effectiveness cannot be ensured solely through general or special controls. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.
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From page 172... ...
HCFA has recently proposed two new criteria for making national coverage decisions within the agency and has recommended that contractors use the same criteria to make local decisions (Federal Register, 2000~. First, the item or service must demonstrate medical benefit, and second, it must demonstrate added value to the Medicare population.
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From page 173... ...
have recently examined the HCFA process for making coverage and reimbursement determinations and the effect of that process on the medical device industry. The group concluded that although the recently redesigned national coverage process is an improvement over the previous process, it can still be unpredictable and time-consuming, especially for novel or breakthrough tech4The Lewin Group was commissioned by the Advanced Medical Technology Association tAdvaMed' to conduct a study on the current situation of the u.s.
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From page 174... ...
is an independent 5Authorized by the Healthcare Research and Quality Act of 1999 (see http:// www.AHRQ.gov/~. 6The 12 EPCs are Blue cross/slue Shield Association Technology Evaluation center, Chicago, Illinois; Duke university, Durham, North Carolina; ECRI, Plymouth Meeting, Pennsylvania; Johns Hopkins university, Baltimore, Maryland; McMaster university, Hamilton, Ontario, Canada; MetaWorks, Inc., Boston, Massachusetts; New England Medical center, Boston, Massachusetts; Oregon Health sciences university, Portland, Oregon; Southern California Evidence-sased Practice Center-RAND, Santa Monica, California; Research Triangle Institute and university of North Carolina at Chapel Hill, Chapel Hill, North Carolina; university of California, san Francisco, Stanford university, Stanford, California; and university of Texas Health sciences center, san Antonio, Texas.
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From page 175... ...
State Mandates State legislatures often require public and private insurers to cover or at least offer coverage for specific medical interventions or procedures. Breast cancer screening is by far the most frequently mandated coverage among screening tests for cancer.
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From page 176... ...
Private Insurers and Managed Care The evaluative science of technology assessment has been expanding in the private sector since the 1980s, and commercial health plans increasingly use these assessments, when they are available, to determine evidence-based coverage decisions (Aubry, 1998~. In the past, health care insurers, purchasers, and providers relied on ad hoc opinion by experts in making coverage decisions, but virtually all now have formal technology assessment programs or more structured decision-making processes for determination of coverage (Perry and Thamer, 1999~.
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From page 177... ...
Independent Technology Assessment Organizations The increased interest in evidence-based medicine and technology assessment has also provided incentives to launch private firms that specialize in medical technology assessment. One of the oldest and largest private firms is ECRI, whose Health Technology Assessment Information Service has been designated an EPC by AHQR.
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From page 178... ...
In the case of coverage decisions, the major focus is on efficacy and effectiveness. Efficacy is a measure of whether a device or procedure has utility among a group of patients in an ideal setting (e.g., a clinical trial)
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From page 179... ...
In a randomized clinical trial, study participants are randomly assigned to either (1) a group that receives the test or treatment in question or (2)
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From page 180... ...
A recent report in the New England Journal of Medicine even suggests that when they are well designed, the results of observation studies and experimental studies may be statistically indistinguishable (Concato et al., 2000~. If a screening test is already in common use, it can be very difficult to randomly assign test subjects to screened or unscreened test groups.
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From page 181... ...
Several investigators have suggested criteria for the evaluation of new diagnostic tests (Lijmer et al., 1999; U.S. Preventive Services Task 10The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial will study 148,000 volunteers.
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From page 182... ...
. The criteria for an appropriate evaluation of a screening test include all the criteria for evaluation of a diagnostic test, but because of differences between screening and diagnosis, several features are unique.
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From page 183... ...
Because of these two features, evaluation of a new screening test is more difficult than evaluation of a new diagnostic test. However, if a test is to be used for screening, it is critical to evaluate it for that purpose because many good diagnostic tests are poor screening tests.
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From page 184... ...
Because multiple randomized controlled trials have demonstrated the effectiveness of mammography in combination with follow-up therapy, it may not be necessary to require that each new technology developed for breast cancer screening be evaluated in a new randomized clinical trial. Instead, the technology could be evaluated as outlined above, with the reference standard being a combination of mammography, pathological verification of cancer, and follow-up observation.
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From page 185... ...
In addition, because all health care is not benign, that is, many diagnostic tests and treatments can initiate a series of untoward health outcomes, QALYs provide additional value in being able to capture the negative effects of health-related quality of life. For example, in the case where an antibiotic therapy were to "cure" an infectious disease but, as a side effect, induced permanent hearing loss, QALYs would record the increased life expectancy positively but could also capture the decrement in health-related quality of life associated with deafness.
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From page 186... ...
For screening tests, this linkage can be elusive. For example, although it may be possible to demonstrate that a particular screening test detects a disease earlier in the disease process than another test does, that information alone does not provide adequate information about the effectiveness of the test in either prolonging life or improving its quality.
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From page 187... ...
Data linking the newer breast cancer detection technologies to reduced breast cancer mortality rates for women are lacking. To conduct a cost-effectiveness analysis of any of the technologies examined in this report, investigators would need to estimate the level of effectiveness of a technology in extending the length of life or would need to estimate the improvements in health-related quality of life that would accompany use of the technology.
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From page 188... ...
Although physicians and patients are to some degree aligned in wanting "the best" no matter what the cost, manufacturers are more influenced by their need to sell their products in the marketplace. FDA and HCFA are not authorized to review the costeffectiveness of medical devices, and at present, neither HCFA nor private insurers are explicitly using cost-effectiveness analyses in their coverage decisions.
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From page 189... ...
Because of this conundrum, the concept of "conditional coverage" has been explored as a potential way to allow new medical technologies to enter the market before a final and definitive yes-or-no decision about coverage is made. Conditional coverage in either the public or private sector refers to limited, temporary coverage under specified conditions to allow collection of data that can be used to determine the value of a technology and to set a definitive coverage policy.
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From page 190... ...
NCI BREAST CANCER SURVEILLANCE PROGRAM TO MEASURE EFFECTIVENESS Technology assessments are perhaps most useful when they reflect everyday medical practice rather than just the experience of the technology developers in controlled environments. The benefit of medical technologies as predicted from controlled clinical trials may not be realized in general clinical practice because there are more variations in both the
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From page 191... ...
to create such systems, NCI established BCSC in 1994 to evaluate population-based screening mammography in the United States.l3 The three major objectives of the Surveillance Consortium are to: · Enhance the understanding of breast cancer screening practices in the United States through an assessment of the accuracy, cost, and quality of screening programs and the relation of these practices to changes in breast cancer mortality or other shorter-term outcomes, such as stage at diagnosis or survival. · Foster collaborative research among consortium participants to examine issues such as regional and health care system differences in the provision of screening services and subsequent diagnostic evaluations.
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From page 192... ...
The mammography registry may also serve as a resource for intervention trials to study ways to improve compliance with recommendations for screening mammography. REIMBURSEMENT Reimbursement rates can vary greatly, depending on the location, health insurance carrier, and other factors, even if coverage decisions are lathe age distributions of women currently receiving mammography within the database are 8%, 31%, 26%, 19%, and 16% for women ages less than 40, 40 to 49, 50 to 59, 60 to 69, and 70 and older, respectively.
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From page 193... ...
Screening mammography is unique in that it is not reimbursed using RVUs, but rather by a special statutory rule (Farria and Feig, 2000~. The payment rate, which is updated annually, is split between a technical fee (68 percent)
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From page 194... ...
A relevant model for this phenomenon is the ThinPrep Pap Testl6 for cervical cancer screening. After several years of testing, the ThinPrep Pap Test was shown to have a small positive effect on patient
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From page 195... ...
Screening mammographya NAa 21.5 NAa 45.8 Bilateral diagnostic mammography 0.90 31.30 1.40 48.60 Unilateral diagnostic mammography 0.74 25.70 1.14 39.60 Breast sonography 0.71 24.70 1.13 39.20 MRI, unilateral breast 2.15 74.70 19.10 663.80 Stereotactic core breast biopsy 2.13 74.00 6.20 270.20 Wire needle localization 0.73 25.40 1.40 48.60 Aortogram 0.71 24.70 13.67 474.80 Chest radiograph 0.29 10.10 0.67 23.30 Foot radiograph 0.21 7.30 0.53 18.40 MRI of brain 1.96 68.10 12.15 422.00 CT of abdomen with contrast 1.68 58.30 7.42 257.70 CT of brain without contrast 1.13 39.20 5.13 178.20 Three-phase bone scan 1.35 49.60 5.18 Barium enema 0.92 32.00 1.86 Transv a gin al ultrasound 0.92 32.00 179.90 64.60 1.66 57.70 aScreening mammography services for Medicare beneficiaries are not reimbursed by using RVUs but are reimbursed under a special statutory rule (Farria and Feig, 2000~.
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From page 196... ...
Uncertainty about the scientific outcome of research is inevitable, but uncertainty about the market profitability also results from the unpredictability of coverage decisions by public and private health insurers. HCFA coverage policy has been changing and evolving in recent years, adding to the high-risk atmosphere for device developers who face uncertainties about the specific coverage criteria that will be applied to devices.
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From page 197... ...
, FDA, NCI, HCFA, and private insurers should coordinate the oversight and support of clinical trials to assess patient outcomes through approval of an investigational device exemption from FDA and conditional coverage from the insurers. HCFA and private insurers would provide conditional coverage for use of the technologies in approved clinical trials, whereas the technology sponsors and NCI could cover additional costs attributable to the study design.
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From page 198... ...
98 MAMMOGRAPHY AND BEYOND When FSM was introduced, FDA approval was not required, and it represented a "void-filling" technology. As a result, new technologies face a much different level of assessment that will likely include comparison with mammography.
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