HMSA Akamai Advantage® Plans Clinical Research Studies (Clinical Trials) Coverage

Description

A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

Original Medicare

Original Medicare offers the option to join some clinical trials for the diagnosis and treatment of illnesses. If a member joins a covered clinical trial, Original Medicare will pay for routine costs of qualifying clinical trial services as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries that are provided in either the experimental or the control arms of a clinical trial.

Original Medicare may pay for items and services in clinical research studies under three policies:

1. Clinical Trial Policy (CTP)

   • The Clinical Trial Policy (CTP) is a National Coverage Determination (NCD) that covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.
   • Refer to the NCD for Routine Costs in Clinical Trials (310.1) webpage for additional information

2. Investigational Device Exemption (IDE) Policy

   • Medicare may cover certain items/services in Food and Drug Administration (FDA)-approved Investigational Device Exemption (IDE) trials

     • Category A (Experimental) device refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. This device shall not be reported on practitioner claims since these devices are not eligible for payment under Medicare.
     • Category B (Non-experimental/investigational) device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type. This device can be reported on a practitioner’s claim.
   • Refer to the Approved IDE Studies webpage on cms.gov for the IDE approved studies that have met CMS’ standards for coverage

3. Coverage with Evidence Development (CED)

   • Medicare may make a National Coverage Determination (NCD) that requires participation in certain clinical trials, longitudinal studies (a research design that involves repeated observations of the same variables), or registries for coverage of an investigational item/service and routine and related items/services
   • CMS, as part of the National Coverage Determination (NCD) may determine coverage of an item of service only in the context of a clinical study
   • Refer to the Coverage with Evidence Development webpage on cms.gov for a listing of approved clinical studies for that specific NCD

HMSA Akamai Advantage

Original Medicare pays for the costs of AA members participating in CMS-approved clinical trials to include routine costs, as specified in NCD 310.1, and any coverage for the diagnosis or treatment of complications related to clinical trial.

MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollee’s participation in a non-plan-sponsored clinical trial.

AA pays for the following:

• AA plans pay the member the difference between original Medicare cost-sharing incurred for qualified clinical trial items and services and the MA plan’s in-network cost-sharing for the same category of items and services. This cost-sharing reduction requirement applies to all qualifying clinical trials as defined in the NCD manual, Pub. 100-03, Part 4, section 310.1. e.g., a lab test that costs $100 as part of the research study. Member’s share of the costs for this test is $20 under Original Medicare, but the test would be $10 under AA plan’s benefits.

In this case, Original Medicare would pay $80 for the test and AA plan pays $10 and member is responsible to the $10 copay.

• AA plans pay for CMS-approved Investigational Device Exemption (IDE) Category A and Category B. May apply utilization management, including prior authorization.
• Clinical Trials Approved Under Coverage with Evidence Development (CED)
  • Claims are submitted to HMSA (unless CMS determines that the significant cost threshold is exceeded for that item or service).
  • Note: If the significant cost threshold is exceeded for an item or service, HMSA will NOT have to cover the item/service until the payment for the item/service can be accounted for in our payment rate from CMS. This payment adjustment usually occurs in the contract year for which payments are appropriately adjusted to take into account the cost of the National Coverage Determination (NCD) service or legislative change in benefits. Refer to section 422.101(b)(1) of title 42 of the Code of Federal Regulations (CFR) for additional information on the significant cost requirement.

References

1. Section 10.7 [PDF], Medicare Managed Care Manual Chapter 4 – Benefits and Beneficiary Protections
2. Noridian Clinical Trials

Revision History