Billing in clinical trials, which can include the device itself and any routine care associated with the procedure/product use, can be advantageous for two primary reasons:

1. It is an opportunity to establish billing and claims history early on for the product, which can help to expedite coding, coverage, and payment upon commercialization; and
2. It can significantly reduce the overall cost of the trial by having the sites bill Medicare (and other payers, although commercial payers are less likely to pay for patients in clinical trials).

Some companies choose not to have the sites bill because they are leery of potential delays to enrollment due to prolonged negotiations and to the CMS review time. Our experience is that these risks can be mitigated, however.

Billing in clinical trials has changed recently, so we thought it was important to summarize where it has been and where it is heading.

In 1995, the Centers for Medicare and Medicaid Services (CMS) published a rule permitting Medicare Administrative Contractors (MACs) to cover medical devices being studied as part of an FDA-approved IDE clinical trial (this does not apply to 510(k) studies). The rule was intended to encourage participation in clinical trials by Medicare beneficiaries. Under this rule, the FDA developed a device categorization to differentiate between novel devices (Category A) and new generations of FDA approved/cleared devices (Category B). Medicare permits, but does not mandate, coverage of Category B devices, assuming they meet all other necessary Medicare requirements.

In 2013, CMS issued a revised Clinical Trial Policy to be implemented January 1, 2015. These new rules centralize the policy, taking decision-making power away from the MACs and providing it to CMS at the national level. The ten requirements of the study for coverage are defined in the policy as follows:

• The principal purpose of the study is to test whether the device improves health outcomes of appropriately selected patients.
• The rationale for the study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
• The study results are not anticipated to unjustifiably duplicate existing knowledge.
• The study design is methodologically appropriate and the anticipated number of enrolled subjects is adequate to confidently answer the research question(s) being asked in the study.
• The study is sponsored by an organization or individual capable of successfully completing the study.
• The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR part 46.
• Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Studies of all medical technologies measuring therapeutic outcomes as one of the objectives may be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment options.
• The study is registered with the National Institutes of Health (NIH) National Library of Medicine’s (NLM) ClinicalTrials.gov.
• The study protocol describes the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes and that the release should be hastened if the study is terminated early.
• The study protocol must describe how Medicare beneficiaries may be affected by the device under investigation, and how the study results are or are not expected to be generalizable to the Medicare beneficiary population. Generalizability to populations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described.

CMS has also made it clear how this applies to study sponsors:

• Prior to January 1, 2015: IDE studies approved by the MACs prior to 1/1/2015 will continue to be administered by each respective MAC. Study sponsors do not have to submit the protocol to CMS if the participating study investigator sites have already received approval from their MAC.
• On/After January 1, 2015: Parties with FDA approval letters dated January 1, 2015 or later must submit request packets to CMS. CMS has provided all of this information at the following link: http://www.cms.gov/Medicare/Coverage/IDE/index.html, which includes information on: • Materials that need to be included in an IDE request packet to CMS;
• Methods to submit the IDE request packet; and
• Background on the review process, which includes a 30-day turnaround time.

It is important to be aware of these rules as you plan your clinical trials, with your strategy for successful reimbursement in mind throughout product development.