CMS Pub. 100-16, ch. 4, § 10.7.1

For clinical trials covered under the Clinical Trials National Coverage Determination

310.1 (NCD) (NCD manual, Pub. 100-03, Part 4, section 310), original Medicare covers

the routine costs of qualifying clinical trials for all Medicare enrollees, including those

enrolled in MA plans, as well as reasonable and necessary items and services used to

diagnose and treat complications arising from participating in qualifying clinical trials.

All other original Medicare rules apply.

Refer to the Medicare Clinical Trial Policy at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA and

for more information on the definition of routine costs and the clinical trial Medicare

qualification process. This policy does not withdraw Medicare coverage for items and

services that may be covered according to Local Coverage Determinations (LCDs) or the

regulations on category B investigational device exemptions (IDE) found in 42 CFR 405,

Subpart B, 411.15, and 411.406. MAOs may contact the Medicare Administrative

Contractor (MAC) for information about qualification and payment for clinical trial items

and services.

MAOs pay the enrollee 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. MAOs may not choose the clinical trial or clinical trial items and services

to which this policy applies. The MAO owes the difference even if the enrollee has not

yet paid the clinical trial provider. Additionally, the enrollee's in-network cost-sharing

portion also must be included in the plan’s out-of-pocket maximum calculation.

To be eligible for reimbursement, an enrollee (or providers acting on the enrollee’s

behalf) must notify their plan that the enrollee received a qualified clinical trial service

and provide documentation of the cost-sharing incurred, such as a provider bill. MAOs

also are permitted to seek the MA enrollee’s original Medicare cost-sharing information

directly from clinical trial providers.

MA enrollees are free to participate in any qualifying clinical trial that is open to

beneficiaries in original Medicare. If an MAO conducts its own clinical trial, the MAO

can explain to its enrollees the benefits of participating in its clinical trial; however, the

MAO 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, even if the MAO believes it is

sponsoring a clinical trial of a similar nature. Examples of impediments to an enrollee’s

participation include, but are not limited to, requiring enrollees to pay the original

Medicare cost-sharing amount for routine care services before being compensated by the

MAO for the difference or unduly delaying any required cost-sharing refund. Enrollees

retain the right to choose the clinical trial(s) in which they wish to participate. However,

an MAO may request, but not require, enrollees to notify the plan in advance when they

choose to participate in Medicare-qualified clinical trials.