A total of patients studied over the past twelve years, with only 79 of the patients receiving the proposed treatment, is not a large enough sample to support a change in the coverage policy. More studies with larger control and experimental groups must be evaluated using regimens designed to isolate variables and correlate them to positive results. Ideally, these studies would consist of improvements in both objective and subjective measurement tools.
However, substantial and statistically significant improvements in subjective pain scores could be persuasive if HCFA could attribute the patient benefit to the prolotherapy regimen. Abraham submitted a number of additional materials to support his request. The materials included some articles describing the technique and increased awareness of prolotherapy, as well as some listings of conferences and member organizations in which prolotherapy is taught and practiced.
While this information supports Dr. Some of the materials Dr. Abraham provided noted that further studies on the benefits of prolotherapy are now being conducted. Should these additional studies be developed with larger sample sizes and should the results be based on objective measures that can clearly attribute the claimed benefits to the therapy under investigation, HCFA would be happy to reconsider the issue.
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Barrett Stay Away from Lorraine Day. Notice an error on this page? Report an Issue. Changes also have been made both to the filing instructions and to the electronic format instructions. Effective dates vary because of the differing implementation dates established by the BBRA. Non-implantable pelvic floor electrical stimulators. HCFA has moved the reference for this equipment from Sec. Artificial hearts. Partial hospitalization services.
Type of service codes. H codes for state and federal agencies are added along with the corresponding type-of-service TOS codes. Durable medical equipment. Because such devices now are considered durable medical equipment, Sec. ESRD network organizations. Blood clotting factor. Form locator 46 should be used to report IUs of any of the clotting factors as one unit. Home use of durable medical equipment. HCFA also has added Sec. Additionally, HCFA has expanded the definition of what medical information is required to bill for oxygen.
Revisions to Program Integrity Manual. Because much of the material in chapters 1 9 has been relocated or reorganized, HCFA has reissued the bulk of the manual without redlining. Osteogenic stimulation. Additionally, a beneficiary must have failed at least one surgical intervention for treatment of the fracture to qualify for coverage. Claims processing system delay. This delay will give intermediaries more time to test the release. AB Dec. AB should not be implemented until further notice. A Dec.
Correct coding edits. B Dec. Pelvic electric stimulators. Coverage appeals. Physicians have ethical and legal obligations to provide appropriate care but such obligations imperfectly safeguard the quality of care received by patients. Patients might understandably interpret HCFA's reimbursement for treatment with such devices as signifying endorsement of that treatment.
Third, restriction of reimbursement for investigational devices reinforces incentives for device manufacturers to comply with and complete the FDA approval process. Since these manufacturers must obtain FDA approval in order to market their devices and recoup the frequently enormous investments they have made in research and development, they are motivated to comply with FDA requirements.
Although the FDA device approval system has been subject to criticism, [35] it does promote a knowledge-based approach to use of medical devices because it encourages manufacturers to sponsor scientifically and ethically sound studies of their devices. The potential for abuse of the the investigational device process is demonstrated by the case of C. Bard Inc. Fourth, denial of reimbursement for investigational devices may help slow the rise in Medicare reimbursement costs.
New technology is a frequently cited cause for increases in health care costs. Since dollars available to spend on Medicare reimbursement is limited, excluding payment for investigational devices may provide a mechanism for rationing those dollars. Finally, a broad rule excluding all unapproved devices is easier and less cosdy to administer than rules providing more particularized guidance for judging the reasonableness and necessity of medical care.
Ironically, administrative costs incurred limiting coverage for the purpose of cost-control can result in overall increases in health expenditures. Although the rationales for denial of coverage for investigational devices have some force, the consequences of such denial may not be as favorable as those rationales suggest.
First, an absolute requirement of FDA approval may not properly provide for the reasonable clinical needs of many patients. While the requirement for FDA approval appropriately excludes coverage for devices which FDA has rejected as well as for untested devices, it also excludes payment for unapproved devices which are reasonable and necessary for health care.
The FDA itself has accepted departures from the approval process thus acknowledging that unapproved medical devices may be required for emergency use [39] and that unapproved uses of approved drugs may be medically appropriate.
Limitations in FDA resources produce substantial backlogs, the number of overdue k submissions increasing from in to 1, in The increased FDA backlog since then has increased the impact of the FDA approval requirement since it is now more likely that reasonable and necessary devices will remain unapproved for significant periods of time. Second, although denying payment for service considered "experimental" or investigational" is a standard method of avoiding diversion of funds for clinical care to fund research, such terms may obscure the complexity of distinguishing research from clinical purposes and distinguishing unproven from proven therapy.
Ethical clinical research depends on the presumption that study of a device to further define its clinical benefit can be made consistent with the appropriate treatment of patients participating in. Although "investigational" is commonly understood as being synonymous with "experimental" or "unproven", "investigational" is a also a term of art in the FDA device approval process.
Medical devices which are awaiting FDA approval for marketing receive "investigational device exemptions" for clinical testing and limited clinical use. A device may be "investigational" in the sense of not having received marketing approval although its effectiveness and safety has been scientifically proven. While the FDAs role as protector of the safety of the medical devices requires it to forestall approval of such devices until it has the time to evaluate their risks, sick patients also face the risks of their own illnesses which require treatment in a timely fashion.
A delay in device approval in the name of safety may actually produce a net loss in lives and increase in morbidity. The technology coverage rule itself contains provisions which attempt to accommodate urgent needs for medical care which cannot wait for slow, albeit sound, administrative approval processes.
First, the rule provides for coverage of certain investigational cancer drugs for terminally ill cancer patients. The provision permitting less stringent proof of safety and effectiveness for breakthrough medical or surgical procedures conflicts with denial of payment for investigational devices since many of these breakthrough medical or surgical procedures require investigational devices for their implementation. Third, denial of Medicare reimbursement for all investigational devices is not a prerequisite for assuring that device manufacturers comply with the FDA approval process.
If reimbursement for investigational devices were subject to limitations such as facility or patient selection criteria as well as subsequent revision, manufacturers would remain motivated to obtain FDA approval. Current FDA regulation prohibits investigators from charging subjects a price larger than that necessary to recover costs of manufacture, research, development and handling. While allowing manufacturers to charge for investigational devices may encourage the development of medical devices such payments should not be permitted to allow manufacturers to earn profits and thus escape the requirement of the FDA.
If the payment manufacturers receive for investigational devices is limited, the chief effct of permitting coverage for investigational devices may be to reimburse hospitals for providing services related to the medical device use. Fourth, although denial of payment for all investigational devices may decrease the cost of Medicare reimbursement such cost-cutting is justifiable only if it is consistent with appropriate medical care. Potential gains in cost-containment from such denial must be balanced against potential health benefits lost.
Such balancing is not possible when an across-the-board rule is in effect. An across-the-board exclusion of unapproved devices is inconsistent with the detailed criteria and procedures for HCFA decisions for health care technology set up in the technology coverage rule. Furthermore, denial of reimbursement for medically necessary investigational devices will not necessarily save Medicare costs.
If use of an investigational device offers care that is safer or more effective or more appropriate than available alternatives, Medicare expenditures may actually increase if coverage for the investigational device is not made available.
Finally, low administrative cost does not justify adherence to a rule which produces unfair results. Although no administrative process can perfectly identify reasonable and necessary services, denying coverage for all investigational devices may approach the decision by too rough a cut.
If some investigational devices are necessary for appropriate medical care, the denial of reimbursement for such devices might trigger a variety of consequences contrary to law and public policy. If many provides and patients dispute denial of coverage for investigational devices the initial administrative cost savings may be lost. Even if a device is inexpensive or free, Medicare denial of payment for all services "related to" an excluded service may result in substantial uncovered costs.
Consider the following potential consequences of denial of coverage for necessary investigational devices:. Hospitals and physicians continue to provide the investigational device to some or all patients for whom the device is appropriate. Patients with sufficient funds or other insurance coverage to pay for the investigational device pay health care providers for the device and related services.
However, patients told that Medicare has determined that such care is not "reasonable and necessary" may refuse treatment on the basis of that judgment even though the device is actually reasonable and necessary for their care.
Patients lacking funds or insurance to pay for the investigational device receive the device and related services free of charge. Costs of the device and related services may be shifted to other insurers and patients. Hospitals that continue to provide the device may suffer considerable Ions and may be put at a competitive disadvantage because they have fewer funds available to provide services or amenities compared to hospitals who do not suffer the expense of providing such charity. Patients who are unable to pay for the device are selectively denied the device.
They may then receive care that is less appropriate or beneficial than treatment involving the investigational device. However, Medicare regulations provide for termination of providers who discriminatorily deny care to Medicare patients.
Physicians and hospitals are dissuaded from offering medically appropriate investigational devices to all patients. Although Medicare's technology rule directly applies only to Medicare patients, health care providers may deny the technology to all patients for two reasons.
First, the scope of coverage by other insurers often mirrors that of Medicare so patients who have insurance other than Medicare may also lack coverage for the devices. Tort law demands that health care providers provide appropriate care. Although use of an investigational device is not generally thought of as "standard" for malpractice purpose, courts have noted that physicians with special knowledge or expertise are required to employ such faculties in treating their patients.
Thus, across the board denial of reimbursement for investigational medical devices may conflict with HCFAs goals of protecting the quality of care received by Medicare patients and of assuring that Federal funds are expended only for medical services that are appropriate to meet an individual's medical needs.
HCFA has signaled interest in enforcing the exclusion of coverage for investigational devices.
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