GINA & DTC

Question 1

What are challenges of personalized medicine?

Answer 1

• Legislative logistics
• Intellectual property
• Regulatory oversight: FDA
• Reimbursement
• Privacy, confidentiality and patients’ rights
• IT infrastructure

Question 2

What is GINA?

Answer 2

Genetic Information Nondiscrimination Act

• Makes it illegal for health insurers or employers to discriminate against individuals based on their genetic information.
• Prevents insurers from denying coverage, adjusting premiums on the basis of genetic information or requesting that an individual undergo a genetic test.
• Prohibits employers from using genetic information to make hiring, firing, or promotion decisions.
• Limits an employer’s right to request, require or purchase an employee’s genetic information.

Question 3

What does GINA legislation NOT address?

Answer 3

Will help the advancement of genomic medicine overall, but does not address:

• Life insurance
• Disability insurance
• Long term care insurance

Question 4

What is DTC?

Answer 4

• Direct-to-consumer (DTC) genetic testing refers to genetic tests that are marketed directly to consumers via television, print advertisements, or the Internet
• Also known as at-home genetic testing
• Provides access to a person’s genetic information without necessarily involving a doctor or insurance company in the process

Question 5

Why do people choose DTC testing? Problems?

Answer 5

1. Identity-seeking: identifying ancestry, paternity and ethnicity

2. Disease risk-testing for health care

3. For curiosity – searching for a better lifesty

“My biggest concern is that members of the public are getting tests that they don’t understand, and their physicians may not understand, and they may be making big decisions that are ill-informed.”

Question 6

What insurance is not protected by GINA?

Answer 6

• Life insurance
• Disability insurance

Question 7

A company found that one of his employees who was up for promotion had a BRCA mutation and denied the raise stating that they anticipate health problems and hence do not want her in the higher post. Is this ok?

Answer 7

Not okay

Question 8

Name two problems with DTC

Answer 8

1. Validity of data
2. Utility of risk SNPs in predicting disease