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Clinical Policy Bulletin:
Clinical Trials, Coverage of Routine Patient Care Costs
Number: 0466


Policy

Notes:

  1. 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:

    1. All applicable plan limitations for coverage of out-of-network care will apply to routine patient care costs in clinical trials; and
    2. 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
    3. Members must meet all applicable plan requirements for precertification, registration, and referrals; and
    4. 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).
       

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

  3. Aetna does not cover the following clinical trial costs:

    1. Costs of data collection and record keeping that would not be required but for the clinical trial; and
    2. Items and services provided by the trial sponsor without charge; and
    3. 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
    4. Other services to clinical trial participants necessary solely to satisfy data collection needs of the clinical trial (i.e., "protocol-induced costs").


Background

This policy was adapted from Centers for Medicare & Medicaid Services policy on coverage of routine care costs in clinical trials.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other HCPCS codes related to the CPB::
G0293 Noncovered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in a Medicare qualifying clinical trial, per day
G0294 Noncovered surgical procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day
S9988 Services provided as a part of a phase I clinical trial
S9990 Services provided as a part of a phase II clinical trial
S9991 Services provided as a part of a phase III clinical trial
S9994 Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion
S9996 Meals for clinical trial participant and one caregiver/companion
Modifier Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Modifier Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study
Other ICD-9 codes related to the CPB:
V70.7 Examination of participant in Clinical Trial


The above policy is based on the following references:
  1. The White House, Office of the Press Secretary. President Clinton takes new action to encourage participation in clinical trials. Medicare will reimburse for all routine patient care costs for those in clinical trials. White House Press Release. Washington, DC: Office of the Press Secretary, The White House; June 7, 2000.
  2. National Academy of Sciences, Institute of Medicine. Extending Medicare Reimbursement in Clinical Trials. Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries. Aaron HJ, Gelband H, eds. Washington, DC: National Academy Press; 2000.
  3. U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Medicare coverage of clinical trials. Proposed National Coverage Decision. Baltimore, MD: HCFA; 2000. Available at: http://www.hcfa.gov/quality/8d1.htm. Accessed August 15, 2000.
  4. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS). Decision Memorandum for the Clinical Trials Policy (CAG-00071R). Baltimore, MD: CMS; July 9, 2007. Available at: https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=186. Accessed July 16, 2007.
  5. Palackdharry CS, Evans DL, McDonough RS, et al. Payer coverage for patients enrolled onto clinical trials: Making the process easy and transparent for everyone. Am J Manag Care. 2012;18(2 Spec No.):SP91-SP97.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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