Billing Plans for Routine Care Essential When Patients Enroll in Clinical Trials

February 1, 2007

As government pressure to reduce healthcare spending increases, gaps in Medicare coverage for participation in clinical trials is a potential barrier that could compromise the ability to conduct valuable medical research.

As government pressure to reduce healthcare spending increases, gaps in Medicare coverage for participation in clinical trials is a potential barrier that could compromise the ability to conduct valuable medical research. Cancer Care — Economics (CC&E) recently spoke with Lisa R. Pitler, JD, MS, RN, Senior Director of the Research and Clinical Trials Administration Office at Rush University Medical Center, Chicago. Ms. Pitler discussed the necessity of effective and compliant billing plans for clinical trials.

CC&E: In a nutshell, how does Medicare cover reimbursement for participation in cancer clinical trials?

MS. PITLER: As of Sept. 19, 2000, the Medicare National Coverage Determination (NCD) on Clinical Trials ensures Medicare beneficiaries access to qualifying clinical trials and coverage for reasonable and necessary items and services to treat complications, providing the clinical trial has therapeutic intent and enrolls patients with a diagnosed disease, and the item or service falls within a Medicare benefit category and is not statutorily excluded from coverage. To qualify for Medicare coverage, a trial must meet the criteria stated and be FDA approved.

CC&E: What is the distinction of routine care in Medicare's coverage policy?

MS. PITLER: Medicare currently defines routine care as items or services that would normally be provided absent a clinical trial, services required solely for the provision of an investigational item or service, and care needed to diagnose and treat trial-related complications. However, routine care hasn't been defined precisely enough to satisfy the divergent opinions among clinical investigators, compliance personnel, and attorneys.

Simply put, if you have seven lung cancer patients on clinical trial and you have seven lung cancer patients who, for various reasons, wouldn't qualify for the trial, would you provide them with the same kind of care? That's the kind of routine care question we've been looking at.

It's important that clinicians understand that even though Medicare might not cover certain treatments, it's not a judgment of the quality of their care, but simply an analysis of what can be billed for and reimbursed.

CC&E: How do local medical review policies affect coverage decisions?

MS. PITLER: They're now called local coverage determinations (LCDs). LCDs are written by local Medicare carriers or fiscal intermediaries to determine local Medicare coverage under Section 1862 (a)(1)(A) of the Social Security Act. Basically, an LCD determines if a treatment is reasonable and necessary on a local level, whereas NCDs determine what Medicare will cover on a national level. Clinicians can access information on LCDs and NCDs on the CMS website at www.cms.hhs.gov/.

CC&E: How can busy community oncologists be sure they're billing correctly for routine care of patients on clinical trials?

MS. PITLER: It certainly can be challenging. First, clinicians need to note if an item or service would be provided outside a clinical trial, if there are specific guidelines for the conduct of such care, and if there are supportive peer-reviewed journal articles or support in any of the three drug compendia. Reviewing the study objectives from the FDA may give more insight into requirements of a particular study.

CC&E: Does CMS financial scrutiny hinder accrual in clinical trials?

MS. PITLER: No. CMS actually helps trial accrual, as Medicare participation in clinical trials is an expansion of Medicare coverage. Prior to the NCD, there was no coverage for clinical trials. The "scrutiny" is to ensure Medicare covers the specific costs that the law allows.

Moreover, CMS has looked at the current NCD issues that have arisen since its implementation, one of which is clarification of the definitions of routine clinical care costs and investigational costs. In this way, CMS gives clinicians an opportunity to really look at who is paying for what on a clinical trial so they can have a full understanding of their potential financial liability.

CC&E: What should an oncologist be especially aware of when deciding to enroll his or her patient on trial?

MS. PITLER: Well, as I've said, they need to really look at what specific services and therapies are covered. Even if it's a National Cancer Institute (NCI) or a federally funded cooperative group clinical trial that meets the qualifying criteria, clinicians still have to be certain about their billing procedures.

Billing errors can trigger allegations under the False Claims Act, which can lead to charges of insurance fraud. It's better to be extra prudent and contact the local Medicare contractor with any questions pertaining to coverage or noncoverage of an item or service.

CC&E: What's the best way to access the information needed to develop an effective billing plan for clinical trials?

MS. PITLER: Unfortunately, there is no handbook that lays out a billing strategy for clinical trials. Therefore, it's important for physicians to create a relationship with the Medicare contractor. Active communication among peers and self-education initiatives are also important steps in creating a coverage analysis or billing plan. Finally, before entering a study, it is very important to review the negotiated study budget, contract, and informed consent to ensure concordance regarding who is financially responsible for items and services required to conduct the trial.

Although many of these issues seem overly complicated, addressing them in a methodical manner leads to better trial accrual, which benefits both patients and clinicians by enhancing the opportunities of medical research.