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Louisiana

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Mandate coverage of Clinical Trials goes to State Commissioner of Insurance

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Judicial appointees, parents, spouses, adult children, siblings, ascendant/descendant, guardians

         

Age of Consent: 18-minors 16+ may be judicially emancipated are able to consent for research

         

Informed Consent Requirements: See La. R.S. §§ 40:1299.40 & .58

         

IRB Requirements: See La. R.S. §40:1299.40

         

Special Rules for Cancer Research: Insurance requirements only, see insurance section

         

HIV/AIDS Testing: See La. R. S. §§40:1300.13 The Subject MUST stay anonymous unless Written ICF states otherwise. Test results cannot be disclosed through the mail, phone, or any other type of electronic communication. Counseling must be available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

Genetic Testing: Genetic information is considered personal property. ICF (written) is required before info can be disclosed.  There are penalties for non-compliance.

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage

         

Phases Covered: Phases II, III, & IV ONLY

         

Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is  NOT covered

         

Specific Conditions of CT Coverage: Personnel providing treatment are doing so w/in their scope of practice, experience, and training AND no clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that treatment will be at least as efficacious as a non-investigational treatment. IRB Approval is required

 

Mandates for Coverage of Off-Label Rx: Individual & Group insurers AND managed care insurers are required to provide coverage, IF they provide coverage for prescription drugs in general

 

Medically Necessary Services: Medically Necessary Services Covered

 

Experimental or Contraindicated Rx NOT Covered: Contraindicated drug not covered       

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for Clinical Trials use may apply

         

State Codes & Links:

All codes can be found at

http://legis.state.la.us/

 

 

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