Coverage of Experimental and Investigational Procedures

1 Coverage of Experimental and Investigational Procedures Policy 5. The member must: e. Findings, studies or research aetna covers Experimental or conducted by or under the auspices Not be treated off protocol.. Investigational technologies ( , drugs, of federal government agencies and Procedures and devices) when ALL of the Actually be enrolled in the trial. nationally recognized federal research following criteria are met. Note: Some Investigational studies are not institutes including the: 1. The member has a current diagnosis that conducted under FDA scrutiny, but meet all Federal Agency for Healthcare will most likely cause death within one the other criteria. For example, new uses of Research and Quality. year or less despite therapy with currently old technologies, new uses of drugs already approved by the FDA (as these would not National Institutes of Health.)

2 Accepted treatment; and have an IND number). National Cancer Institute. 2. Standard therapies have not been effective in significantly improving the Medical and scientific evidence means National Academy of Sciences. condition of the member or would not the following sources: Centers for Medicare and be medically appropriate; and a. Peer-reviewed scientific studies published Medicaid Services (CMS). 3. The proposed treatment is likely to be in or accepted for publication by medical Any national board recognized by beneficial to the member based on at journals that meet nationally recognized the National Institutes of Health for least two documents of medical and requirements for scientific manuscripts and that submit most of their published the purpose of evaluating the scientific evidence (as defined below); and articles for review by experts who are not medical value of health services.

3 4. The member is to be treated as part of a part of the editorial staff. f. Peer-reviewed abstracts accepted for clinical trial satisfying ALL of the following presentation at major medical criteria: b. Peer-reviewed literature, biomedical association meetings. compendia and other medical literature The Investigational drug, device, therapy that meet the criteria of the National If the criteria listed above are not or procedure is under current review by Institutes of Health's National Library of satisfied, and the member desires the FDA and has an Investigational New Medicine for indexing in index Medicus, reconsideration, the member may Drug (IND) number; and Excerpta Medicus (EMBASE), Medline, or submit an appeal in accordance with MEDLARS database Health Services the relevant appeal process. Any such The clinical trial has passed independent Technology Assessment Research (STAR).

4 Appeal may be expedited when required scientific scrutiny and has also been by the member's medical condition. approved by an Institutional Review c. Medical journals recognized by the Board (IRB) that will oversee the Secretary of Health and Human Services, Note: For Coverage of Category B. investigation; and under Section 1861(t)(2) of the Social Investigational devices, please see Security Act (42 1395x). CPB #164 Coverage of Category B. The clinical trial is sponsored by the Investigational Devices. See also National Cancer Institute (NCI) or similar d. The following standard reference CPB #466 Clinical Trials, Coverage national cooperative body ( , compendia: of Routine Patient Care Costs. Department of Defense, VA Affairs) The American Hospital Formulary and conforms to the rigorous Service-Drug Information, independent oversight criteria as The American Medical Association defined by the NCI for the Drug Evaluations, performance of clinical trials; and The American Dental Association The clinical trial is not a single Accepted Dental Therapeutics, and institution or investigator study (NCI-designated Comprehensive Cancer The United States Pharmacopoeia Center trials are exempt from this Drug Information.)

5 Requirement); and (11/04). Application to products 4. Grant KL. Investigational drug tracking: 13. Laskey WK. Investigational Unless indicated otherwise above, this policy Phases I-III and NDA submissions Part II. intervention: Revisit the paradigm or applies to all fully insured aetna HMO, POS Hosp Pharm. 1994;29(10):900, 902-904, make a new one? Cathet Cardiovasc and PPO plans and to all other plans, unless 906-911 passim. Diagn. 1997;41(4):469-470. a specific limitation or exception exists. For 5. Pritchard WF Jr, Abel DB, Karanian JW. 14. Eddy DM. Investigational self-funded plans, consult individual plan The US Food and Drug Administration treatments. How strict should we sponsor benefit descriptions. If there is a Investigational device exemptions and be? JAMA. 1997 6;278(3):179-185. discrepancy between this policy and a self- clinical investigation of cardiovascular funded customer's plan of benefits, the 15.

6 Investigational new drug devices: Information for the investigator. provisions of the benefits plan will govern. application; exception from J Vasc Interv Radiol. 1999;10(2 Pt 1): With respect to fully insured plans and self- informed consent; technical 115-122. funded non-ERISA ( , government, school amendment FDA. Final rule. boards, church) plans, applicable state 6. Goodman C. Roundtable discussion. Fed Regist. 1997;62(115):32479. mandates will take precedence over either. Investigational exclusion, clinical trials, 16. Beebe DB, Rosenfeld AB, Collins N. Texas specific Coverage issues can be found and cancer. Oncology (Huntingt). An approach to decisions about on the following aetna website: 1998;12(11A):37-49. Coverage of Investigational 7. Paterniti JR Jr. Investigational new drug treatments. HMO Pract. Unless otherwise specifically excluded, applications: The role of the preclinical 1997;11(2):65-67.

7 Federal mandates will apply to all plans. dossier. Am J Cardiol. 1998;81(8A): With respect to individuals covered under a 2002 aetna Inc. Coverage Policy 10F-12F. Medicare+Choice and state Medicaid benefit Bulletins are developed to assist in plan issued, serviced or administered by 8. Priester R, Vawter DE, Gervais KG. administering plan benefits and aetna , this policy will apply unless Medicare Investigational treatments: Process, constitute neither offers of Coverage nor and Medicaid policies extend Coverage payment, and priorities. JAMA. medical advice. This Coverage Policy beyond this Coverage Policy Bulletin. 1997;278(17):1403-1404. Bulletin contains only a partial, general CMS's Coverage Issues Manual can be description of plan or program benefits 9. Meador KJ. Investigational treatments: found on the following website: and does not constitute a contract.

8 Process, payment, and priorities. JAMA. aetna does not provide health care 1997;278(17):1403; discussion 1404. services and, therefore, cannot The above policy is based on the 10. Goldschmidt PG, Monaco GP. guarantee any results or outcomes. following references: Investigational treatments: Process, Participating providers are independent 1. Medical devices; Investigational device payment, and priorities. JAMA. contractors in private practice and are exemptions FDA. Final rule. Fed Regist. 1997;278(17):1402-1403; neither employees nor agents of aetna 1998;63(225):64617-64626. discussion 1404. or its affiliates. Treating providers are solely responsible for medical advice and 2. Fratantoni JC. The IND: What is it and 11. Burt RA. Investigational treatments: treatment of members. This Coverage who needs it? Investigational New Drug.

9 Process, payment, and priorities. JAMA. Policy Bulletin may be updated and Transfusion. 1999;39(4):341-342. 1997;278(17):1402; discussion 1404. therefore is subject to change. 3. Grant KL. Investigational drug tracking: 12. Shulman SR, Manocchia M. The US. June 21, 2002. Phases I-III and NDA submissions Part I. orphan drug programme 1983-1995. Hosp Pharm. 1994;29(9):830-836, Pharmacoeconomics. 1997;12(3): 839-844, 847-852 passim. 312-326. aetna is the brand name used for products and services provided by one or more of the aetna group of subsidiary companies. (11/04) 2004 aetna Inc.