Clinical Trial Reimbursement Integration and Management  

Charles E. Schneider

In recent years, the issue of medical technology reimbursement has moved from passive discussion to the centerpiece of strategic planning. Corporate leaders, investors and inventors now evaluate the reimbursement landscape at the beginning of the product development process and try to anticipate payor trends likely to impact product commercialization in the future. Many understand the need to integrate “reimbursement” into their planning process, but few companies seize opportunities during the clinical trial itself. Equally as important, the need to address management of the study and economic reporting requirements also has become a paramount concern to study administrators.
   
This column briefly describes reimbursement opportunities available during a clinical trial, as well as a few trial management issues and how a keen eye toward reimbursement might well serve the study and commercialization objectives. By the end of the article, you should have a better understanding of insurance coverage opportunities during the clinical trial, as well as some of the mechanisms critical to the successful management of the study from a reimbursement perspective.

Study Coverage

Both public and private payors may elect to provide coverage of healthcare services during the clinical trial. In the United States, the Centers for Medicare and Medicaid Services (CMS) has issued national coverage decisions and rules regarding coverage of clinical trials. The CMS, for example, allows Medicare fiscal intermediaries and carriers the discretion to provide coverage of clinical costs where safety is not a material concern and the study is intended to prove the efficacy of the technology—ie, where the FDA has designated a technology as Category B. In this case, the study site may provide the Part A fiscal intermediary or Part B carrier information about the study, expected enrollment, the FDA designation letter and a request for pre-determination of coverage for clinical and technology services provided during the study. While not generally obligated to do so, some commercial insurance carriers also have elected to provide coverage of clinical service costs during the trial on a case-by-case basis.
   
Advantages for seeking insurance coverage during the trial include introducing the technology to the payor community so each may collect claims data on beneficiaries, without the need to provide full coverage for unknown technologies. Payors also may use these opportunities to validate coding solutions for use following FDA approval and may elect to provide coverage due to their interest in supporting interventions likely to influence clinical outcomes and total cost of care. While partially offsetting costs associated with the study, other benefits include gathering market intelligence about coverage and costs associated with this procedure. Both may be used when establishing your strategic reimbursement plan and developing payor messaging, used as the basis for new code and payment development.

Clinical Trial Reimbursement Solutions

In terms of integrating reimbursement within the clinical study design and management phase of the product lifecycle, there are various options that may be useful, depending on the needs of the sponsor, inventors and investors. Areas of emphasis might include the inclusion of reimbursement considerations within the trial protocol, development of clinical trial agreements that contemplate insurance coverage during the trial, collection of claims and payment data and how best to use these pre-approval opportunities within a strategic reimbursement plan. 
   
While healthcare utilization is important, your reimbursement experts should provide significant counsel regarding clinical trial design, whether payors may object to a particular control population, a cogent statistical plan has been developed a priori, validated measurements are used and will provide information meaningful to the payor community, or patient sub-populations are represented adequately. Questions of bias, analysis that clearly shows outcomes attributed to the technology versus concomitant treatments and evidence demonstrating improvement in net health outcomes all are areas of review by reimbursement experts when evaluating trial protocols, managing financial aspects of the study agreement and evaluating data for use with the insurance community.
   
Next, you should consider the nature of your study and whether sites selected include academic and community centers representing urban and rural markets. The extent to which the study includes geographic, socioeconomic and sub-populations will further strengthen arguments to select payors who may evaluate coverage and payment for the technology. Additionally, investigators and staff must be capable of conducting the study. While many physicians may wish to participate in clinical trials, lack of experience working with sponsors, working within the study budget, satisfying enrollment commitments, long-term follow-up and reporting requirements may frustrate some individuals who have not had previous experience working within a well-designed and managed trial. Such concerns may have an unanticipated impact on the cost of the study and may create unforeseen reimbursement problems if not properly managed.
   
When drafting contracts for clinical trials, the sponsor must decide whether insurance coverage may be available. Well-crafted agreement terms will address provider obligations, define payment values, consider rules governing Medicare coverage and provide a good framework for pre-determination and pre-authorization requirements. In instances where insurance coverage is anticipated, clinical trial agreements should anticipate various payment scenarios, including situations when a sponsor may provide repayment for clinical services provided to the control population, expectations regarding patient co-payments, coinsurance and deductibles, sponsor payments when the carrier has paid less than the contracted value with the sponsor and other examples where the flow of funds must be carefully considered. Claim submission and payment to the physician and facility must be well defined, as must the processes and required documentation necessary for the sponsor to issue repayment.
   
Claims, coverage and payment information may be very useful when collected during the clinical trial. Data may be used for strategic reimbursement planning, supporting future applications for supplemental payments from Medicare as well as developing new codes and value constructs for procedures relating to the technology. When collecting protected health information, however, all parties must remain sensitive to federal and state privacy laws. The trial agreements should enable the submission of de-identified claims, coverage and payment information, with significant safety measures in place to protect the data from unwanted use.
   
With an eye toward the future, a sponsor, inventor or investor should use every effort to anticipate future reimbursement trends. Pay-for-performance models being developed by some payors offer an excellent illustration of a future trend. Studies should consider necessary training required of the clinician and staff to ensure optimal outcomes. This will have a direct impact on future coverage and payment decisions by the payor community. Clinical and economic outcomes will be used by stakeholders influential in the commercialization of your product. Reimbursement experts should evaluate these training programs and provide comment on how best to document the certification process, evaluate the effectiveness of this training and communicate training programs to payors as may be required.

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Whether positioning novel technology for entry into a new market space, anticipating coverage and coding needs, or considering future opportunities to compete within the continuum of care, integration of reimbursement now has become essential to the success of your study and commercial objectives of your product. Reimburse- ment planning and management from the conception of the trial will be a worthwhile endeavor supporting the significant investment required during today’s study of new medical technology. 

SIDEBAR:

Reimbursement Considerations During the Clinical Trial

• Clinical study protocol review
• Study site development
• Clinical trial agreement
• Fair market value for administrative and clinical services
• Pre-determination and pre-authorization requirements
• Insurance payment terms
• Sponsor payment and repayment terms
• IRB and disclosure considerations
• Physician training and certification
• Site education: reimbursement
• Payor coverage during the trial
• Mapping correct coding solutions for use during the trial
• Maintaining HIPAA compliance
• De-identified claims and EOB data collection and reporting
• Using the data during the trial
• Developing a publication strategy useful with payors
• Strategic reimbursement planning
• Product launch and production reimbursement tools
• Post-approval coverage, coding and payment considerations
• Value positioning

Charles E. Schneider directs MCRA’s reimbursement department for its clientele and is responsible for assisting companies in the preparation of coding applications, creating reimbursement pathways (Phase I through Phase IV), preparing submissions for use by commercial carriers (TriCare, Medicare and fiscal intermediaries) and supporting national coverage determinations by the CMS. Working with MCRA’s clinical and regulatory teams, the reimbursement division further supports client needs through coordination of health economic and utilization review outcomes and comparative effectiveness studies, whether they are within an FDA-mandated or marketing study. Please send inquiries to Charles at [email protected].