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Kentucky

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Mandate coverage of off-label drug use goes to State Commissioner of Insurance

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Guardians, Spouses, adult children, parents, adult siblings, & POA

         

Age of Consent: 18-minors who are married, are parents, or who are emancipated. 16+ can consent for mental health

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: KY requires that physicians provide or arrange a counseling referral for patients receiving HIV testing. Test results cannot be disclosed through the mail, phone, or any other type of electronic communication

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only"

         

Genetic Testing: None Specified

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified

         

Phases Covered: None Specified

         

Organization Approved to Conduct: None Specified

         

Specific Conditions of CT Coverage: None Specified

 

Mandates for Coverage of Off-Label Rx: Individual & Group insurers AND managed care insurers are required to provide coverage. Coverage is NOT contingent on the insurer providing coverage for prescription drugs in general.

 

Medically Necessary Services: Medically Necessary Services Covered

 

Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered

         

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

         

State Codes & Links:

All codes can be found at

http://www.lrc.ky.gov/Statrev/frontpg.htm

 

 

Last Updated ( Wednesday, 16 September 2015 14:43 )