The Commonwealth of Massachusetts

Executive Office of Health and Human Services
Department of Public Health
Office of Patient Protection
250 Washington Street
Boston, MA 02108-4619

Phone:  1-800-436-7757
Fax:  617-624-5046

DEVAL L. PATRICK
GOVERNOR
TIMOTHY P. MURRAY
LIEUTENANT GOVERNOR
JUDYANN BIGBY, MD
SECRETARY
JOHN AUERBACH
COMMISSIONER	
REVIEW OF SERVICES CONSIDERED TO BE EXPERIMENTAL OR INVESTIGATIONAL

For decisions that involve services denied by the health plan as experimental or investigational, the reviewer must cite reliable evidence to support the decision. 

Reliable evidence is defined as one or more of the following regarding the effectiveness and efficacy of the proposed treatment: 
•	Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not a part of the editorial staff;
•	Peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institute of Health’s National Library of Medicine for indexing in Index Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS database Health Services Technology Assessment Research (HSTAR);
•	Medical journals recognized by the Secretary of Health and Human Services, under Section 1861(t)(2) of the Social Security Act;
•	The following standard reference compendia: The American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluation, the American Dental Association Accepted Dental Therapeutics, and the United States Pharmacopoeia-Drug Information;
•	Findings, studies and research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes including the Federal Agency for Health Care Policy and Research, National Institutes of Health, National Cancer Institute, National Academy of Sciences, Health Care Financing Administration, Congressional Office of Technology Assessment, and any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health services; and
•	Any other medical or scientific evidence that is comparable to those listed above.

Medical or scientific evidence shall not include published peer-reviewed literature sponsored to a significant extent by a pharmaceutical manufacturing company or medical device manufacturer.

In cases where an appellant is seeking a retrospective review of already-provided services, reviewers must pay close attention to the date on which the services were rendered.  Reviewers should not rely on evidence that was not published or otherwise available on the date the service was rendered.

OPP recognizes that in certain instances involving extremely rare conditions, there may not be any reliable evidence as defined above regarding proposed treatments.  In those instances, the reviewer must cite scientific evidence to support his or her decision.