The new Medicaid clinical research coverage regulation was effective January 1, 2022. While state legislatures are working to amend their State Plans to address what clinical research services will be covered, clinical research sites should take steps now to understand the regulation, take proactive steps to address coverage issues, and await coverage decisions from their states.
Overview of the Medicaid Clinical Research Coverage Regulation
Since 2000 when Medicare issued National Coverage Determination (NCD) 310.1, “Routine Costs in Clinical Trials,” Medicare has been paying for “routine costs” in “qualifying clinical trials.” While many state Medicaid programs have been paying for some costs in clinical trials, the programs have not been required to pay. This new legislation, H.R. 133 - The Consolidated Appropriations Act (SEC. 210. PROMOTING ACCESS TO LIFE-SAVING THERAPIES FOR MEDICAID ENROLLEES BY ENSURING COVERAGE OF ROUTINE PATIENT COSTS FOR ITEMS AND SERVICES FURNISHED IN CONNECTION WITH PARTICIPATION IN QUALIFYING CLINICAL TRIALS.), requires state Medicaid programs to cover certain costs in certain clinical trials. While this regulation would have ideally increased access to and participation in clinical trials, the regulation, as written, may do the opposite. If state legislatures adopt only what is required, this could actually decrease coverage, potentially affecting participation and access.
Clinical research billing operations typically follow Medicare rules for determining what items and services may be billable to payers in clinical trials because Medicare is the driver of reimbursement in the U.S. Many payers follow Medicare rules, so billing operations tend to be geared toward Medicare rules as well. Medicare clinical research coverage rules, or NCD 310.1, are the most sophisticated of all payers, and Medicare billing carries the most risk. Since site coverage analysis is typically oriented around Medicare, this article will contrast Medicare coverage with what the new Medicaid clinical research law requires to be covered. The new Medicaid research regulation requires coverage of a subset of what Medicare pays for. Medicare and Medicaid use similar terms such as “routine” costs and “qualifying clinical trial,” but the terms are defined differently, resulting in differing coverage.
A subset of studies that qualify under Medicare will qualify under Medicaid. While Medicare requires that enrolled patients have a “diagnosed disease,” Medicaid requires that patients have a “serious or life-threatening disease or condition.” Some terms in the new regulation are defined; “serious or life-threatening” is not a defined term. So there will be some studies that qualify for Medicare coverage but do not qualify under Medicaid coverage. Coverage may vary state by state if some states elect to cover more than what is required.
Similarly, a subset of costs that are covered in qualifying trials under Medicare will be covered in qualifying trials under Medicaid. While Medicare covers items and services that are conventional care, items and services that are required for administration of the investigational item, and items and services that are needed to prevent, detect, or manage side effects or complications, Medicaid covers only items and services that are required for administration of the investigational item, and items and services to prevent, diagnose, monitor, or treat complications. The Medicaid law does not require coverage of conventional care. While this may be an element that state legislatures choose to add, states will not be required to pay for conventional care if the state does not adopt a wider approach to coverage.
While this legislation has been applauded, it seems to fall short in its coverage. Unless specific states decide to cover more than what the regulation requires, many clinical research studies will not qualify for coverage. For the studies that do qualify for coverage under this legislation, conventional care may not be covered.
So, what should study sites be doing in response to this legislation?
- Contact your state legislature. Discuss the implications of the regulation, including that, as written, the rule could decrease patient access and put more financial burden on health systems. Ask them to consider expanding coverage beyond what is required by the rule to increase access to patients and not further burden providers.
- Await your state’s State Plan Amendment which will add further clarity to what is covered. State legislatures will be updating Medicaid coverage at a future legislative session. The State Plan Amendment will outline what is covered and what is not covered in your state.
- Know that the new rule requires a prior authorization process, just like many private payers do. The process will include an attestation by the trial site about the appropriateness of the trial (i.e., that the study is peer reviewed, approved through a system of peer review that the Secretary approves, etc.). The prior authorization process is currently being developed, and will include the option to reference clinicaltrials.gov.
- Keep doing a coverage analysis based on Medicare guidelines. As you get further information from your state on coverage, you can add necessary steps as part of the coverage analysis or subsequent to the coverage analysis to segregate charges based on Medicaid coverage rules.
- Insist on indigency clauses in sponsor contracts. Sponsors may contend that indigency clauses are no longer necessary because of the new rule. However, as discussed above, not all studies will qualify for coverage and not all services within qualifying studies will be covered. There will still be many Medicaid patients that will not be able to pay for services, so the sponsor indigency clauses, based on documented financial need, will be essential to maintain enrollment and prevent significant financial loss (i.e., write offs) by the provider site. Additionally, even some private pay patients may qualify for indigency care based on their income, assets, and volume of medical expenses.
Implementation, industry standards, and best practices will continue unfolding and evolving as states determine their coverage and amend their State Plans. Until then, continue doing coverage analysis based on Medicare rules and insist on indigency clauses from sponsors.
- The new Medicaid clinical research coverage rule, found in H.R. 133- The Consolidated Appropriations Act, is effective January 1, 2022, but is not yet implemented in most states since many state legislatures have not yet met to amend their State Plans.
- As written, Medicaid will cover a subset of what Medicare covers. State legislatures can elect to cover more than what is required by the regulation.
- Continue clinical research billing, including the coverage analysis, according to Medicare rules. Once your state has amended its State Plan, a workstream subsequent to coverage analysis may be developed to segregate charges related to Medicaid coverage issues.
- Unlike Medicare, but like private payers, the Medicaid regulation requires a prior authorization. The process for the prior authorization is still being developed.
- Insist that sponsors include indigency clauses in contracts, as the Medicaid regulation will likely not provide the access and coverage that providers were hoping for.
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