This policy was adapted from Centers for Medicare & Medicaid Services (CMS) policy on coverage of routine care costs in clinical trials.

Scope of Policy

This Clinical Policy Bulletin addresses clinical trials, coverage of routine patient care costs.

Policy Limitations and Exclusions

Consistent with Centers for Medicare & Medicaid Services (CMS) policy and Patient Protection and Affordable Care Act (PPACA) requirements, Aetna covers medically necessary routine patient care costs in clinical trials (in the same way that it reimburses routine care for members not in clinical trials) according to the limitations outlined below. All of the following limitations apply to such coverage:

All applicable plan limitations for coverage of out-of-network care will apply to routine patient care costs in clinical trials;

and

All utilization management rules and coverage policies that apply to routine care for members not in clinical trials will also apply to routine patient care for members in clinical trials;

and

Members must meet all applicable plan requirements for precertification, registration, and referrals;

and

To qualify, a clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled. Providers will not routinely be required to submit documentation about the trial to Aetna, but Aetna can, at any time, request such documentation to confirm that the clinical trial meets current standards for scientific merit and has the relevant IRB approval(s).

Aetna covers costs of medically necessary treatments for conditions that result as unexpected consequences (complications) of clinical trials.

Aetna does not cover the following clinical trial costs:

Costs of data collection and record keeping that would not be required but for the clinical trial;

and

Items and services provided by the trial sponsor without charge;

and

The experimental intervention itself (except medically necessary Category B investigational devices and promising experimental and investigational interventions for terminal illnesses in certain clinical trials according to Aetna's terminal illness policy (see benefit plan descriptions for details));

and

Travel, lodging and meals;

and

Other services to clinical trial participants necessary solely to satisfy data collection needs of the clinical trial (i.e., "protocol-induced costs").