Taking the mystery out of Medicare’s coverage policy
By J. Mark Waxman, JD
General Counsel
CareGroup Healthcare System
Boston
|
Last month, the roles and responsibilities of sponsors vs. investigators were outlined. While there are a variety of rules and guidance from various organizations, there is one important rule that should be examined more closely: the Medicare coverage policy for clinical trials. In June 2000, the Health Care Financing Administration (now known as the Centers for Medicaid & Medicare Services — CMS) was directed to explicitly authorize Medicare payment for routine patient care costs and costs due to medical complications associated with participation in clinical trials. This directive led to the publication of a national coverage policy (NCP) binding Medicare carriers and intermediaries when reviewing claims for payment associated with Medicare beneficiaries who are participating in clinical trials.
Coverage rules
The NCP established a general rule for Medicare coverage of:
• routine costs of qualifying clinical trials;
• reasonable and necessary items and services used to diagnose and treat complications arising from participation in ALL clinical trials — qualifying or not.
In interpreting this general rule, there are two important definitions: routine costs and qualifying clinical trials.
Routine costs. Routine costs are those items or services that are generally available to Medicare beneficiaries as a covered item or service. This would typically encompass reasonable and necessary medical care. Such reimbursable costs include the items or services whether provided to the experimental or control group. Allowable costs also would include items or services required for the clinically appropriate monitoring of the effects of the items or services, or to prevent complications.
Routine costs, however, would not include the investigational item or service itself, or items or services provided by the research sponsors free of charge, solely to determine trial eligibility or solely to satisfy data collection and analysis needs that are not used in direct clinical patient management. Billing for such nonallowed routine costs, and in particular for items provided at no cost, will be investigated as a potentially fraudulent billing submission.
Qualifying clinical costs. A qualifying trial must meet a number of criteria — it must evaluate a covered Medicare Benefit, has a therapeutic intent and enrolls diagnosed beneficiaries. It also must have what are specified as "desirable characteristics." To have therapeutic intent, for example, means that a trial designed exclusively to test toxicity would not meet the coverage criteria. Studies with "desirable characteristics" must meet seven standards, including that they do not unjustifiably duplicate existing studies and are sponsored by "credible organizations or individuals capable of executing the proposed trial successfully."
A trial also can be automatically qualified if it is funded by the National Institutes of Health, the Centers for Disease Control and Prevention, CMS, the Department of Defense, or the Veterans Affairs administration, or supported by centers that are funded by these agencies.
Investigational new drug (IND) trials reviewed by the U.S. Food and Drug Administration (FDA) or drug trials exempt from having an IND [see 21 CFR 312.2(b) c] may also be automatically qualified.
It is the job and responsibility of the lead principal investigator (PI) to certify the trial meets the qualifying criteria. If CMS determines that the certification was a misrepresentation, although the enrolled beneficiaries will have no liability, the billing provider will be held liable for the costs and fraud investigations of the billing providers. The PI also may be individually pursued.
In reviewing whether the specific costs incurred during a trial are covered, by regulation certain services are excluded from coverage (see 42 CFR 411.15). Such services exclude routine physical checkups, immunizations except a number of specified exceptions such as flu shots, most cosmetic surgeries and related services, and personal comfort services. It’s also important to remember that applicable deductibles and coinsurance rules must be applied to clinical trial items and services.
There are specific clinical trials coding rules to identify those claims that meet the NCP criteria for payment. The applicable diagnosis code (V70.5) is not a principal diagnosis code, but a subsequent diagnosis code. Submission of a bill with the appropriate QV (the modifier used to identify clinical trial services) procedure code modifier and diagnosis code serves as the attestation that the services provided meet the Medicare coverage criteria. Where a device is involved, the government will use the FDA categorization as a factor in making the coverage decision. In general, devices with an approved investigational device exemption categorized as nonexperimental/investigational (category B) may be considered for payment.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content