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Apple Health (Medicaid) Provider Alert

Frequently Asked Questions for Clinical Trials Policy

Routine Costs

1. What is a “qualifying clinical trial?”
   A trial related to “the prevention, detection, or treatment of any serious or life-threatening disease or condition.” This includes a trial funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), or other federal-approved entities. (Refer to SSA § 1905(gg)(2)(A).)
   
   
2. What are “routine” costs when a client is enrolled in a clinical trial?
   Any item or service provided to “prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial, to the extent that the provision of such items or services to the beneficiary would otherwise be covered outside the course of participation in the qualifying clinical trial under the state plan or waiver, including a demonstration project under section 1115 of the Act.” In other words, a state must cover any items or services that are provided during, or are necessary because of, a beneficiary’s participation in a clinical trial, assuming these services are already covered by the state plan or demonstration project.
   
   
3. What costs are NOT covered?
   The investigational item or service that is the subject of the clinical trial and is not otherwise covered under the state plan, waiver, or demonstration project is not a “routine patient cost” that must be covered under Section 1905(a)(30). For example, the study drug or device is not covered. Services not covered under the state plan but required by the clinical trial are also not covered.
   Routine patient cost does not include any item or service provided to the client solely to satisfy data collection and analysis for the qualifying clinical trial that is not used in the direct clinical management of the client and is not otherwise covered under the state plan, waiver, or demonstration project. See SSA § 1905(gg)(1)(B).
   The example given by CMS concerns medical imaging. If a client has a condition that requires a routine yearly scan, but the clinical trial requires monthly scans for the purpose of clinical trial data collection, these would not be considered as routine costs because they are not for the direct clinical management of the client or standard of care, and are not covered under the state plan, waiver, or demonstration project.
   
   
4. How does this policy differ from current practice for Apple Health?
   There will be no change in payment for routine costs related to clinical trials for fee-for-service (FFS) clients, as these costs have already been covered under the state plan, waiver, or demonstration project before the January 1, 2022, rule took effect.
   Managed care organizations (MCOs) may have differed in their coverage of routine costs related to clinical trials, depending on the MCO; however, they will now be required to follow the coverage policy for routine costs associated with clinical trials as mandated in the new rule.

The Attestation Form

1. Where can the attestation form be found?
   The attestation form is located on CMS’s website and will be on HCA’s Forms & Publications webpage by October 1, 2022. If searching for the attestation form on HCA’s website, use the search term “clinical trials attestation.” Either the researcher or the client’s provider must manage the procurement of the forms. Apple Health is not responsible for providing forms.
   
   
2. The new rule went into effect on January 1, 2022. Do we need to complete forms for all our clients on a clinical trial, even those that enrolled before that date?
   The CMS form was released on July 1, 2022, and therefore was not available for clients enrolled before that date. Apple Health is requiring forms to be completed and returned to either the client’s MCO, or to HCA (for FFS clients) for any client enrolled on July 1, 2022, or after.
   You must submit the form before services are provided to clients enrolled in trials after October 1, 2022.
   All routine costs for clients enrolled in trials before July 1, 2022, will continue to be covered as they have in the past. An attestation form will not be required for those clients unless they are enrolled in a new trial.
   
   
3. Who needs to sign the form?
   The form must be signed by the principal investigator (PI) or their delegated authority (if they have a documented process for the delegation of authority) and the client’s health care provider that is providing the care during the trial. In some cases, the PI, or delegated authority, and the health care providers may be the same individual.
   
   
4. Where does the provider send the form once it is completed?
   For Apple Health FFS clients, submit the attestation form via the ProviderOne portal or via fax at 1-866-668-1214. Include the client’s ProviderOne number. Once HCA receives the form, it will be placed in the client’s electronic file.
   Each HCA MCO may have a different process; however, they must collect the forms before the start of the trial.
   
   
5. Will clinical trials require prior authorization (PA)?
   Participation in a clinical trial itself does not require PA. However, services associated with routine medical costs while in a clinical trial may have PA requirements that still apply. Submit completed PA requests, when required, electronically via the ProviderOne portal or via fax at 1-866-668-1214. For clients in an HCA MCO, providers must follow the process required by the MCO.
   
   
6. What is the geographic location or network affiliation requirement?
   Coverage of routine patient costs cannot be denied based on where the clinical trial is conducted, including out-of-state, or based on whether the principal investigator or provider treating the client in connection with the clinical trial is outside of the network of the client’s HCA MCO. Usual requirements regarding rates, billing processes, and PA for out-of-state care, diagnostics, and interventions apply.