DoL GINA comment

PHARMACEUTICAL CARE MANAGEMENT ASSOCIATIONDecember 9, 2008Office of Health Plan Standards and Compliance AssistanceEmployee Benefits Security AdministrationRoom N-5653U.S. Department of Labor200 Constitution Ave, NWWashington, DC 20210Attention: GINA CommentsTo Whom It May Concern:The Pharmaceutical Care Management Association (PCMA) is grateful for the opportunity topresent comments regarding issues under sections 101 through 104 of the Genetic InformationNondiscrimination Act of 2008 (GINA), and respond to the specific questions posted in theFederal Register.PCMA is the national association representing America’s pharmacy benefit managers (PBMs),which administer prescription drug plans for more than 210 million Americans with healthcoverage, provided through Fortune 500 employers, health insurance plans, labor unions,government programs, and Medicare Part D.Our specific concerns are as follows:B. Comments Regarding Regulatory Guidance3. Under what circumstances do plans or issuers currently request or require anindividual to take a genetic test?9. What terms or provisions would require additional clarification to facilitatecompliance? What specific clarifications would be helpful?The prohibition in GINA on group health plans and health insurance issuers from“requesting or requiring” an individual or family member of an individual to undergo agenetic test has raised concerns by plan sponsors about their ability to “offer” a genetictest prior ...