physician; referrals;
reimbursement
DP |
Committee on Health |
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DP |
Committee on Judiciary |
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DP |
Caucus and COW |
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DP |
Third Read |
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X |
As Transmitted to the Governor |
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Allows physicians to accept payments from a medical researcher in connection with identifying and monitoring patients for a clinical trial.
The United States Food and Drug Administration is currently conducting 3,799 clinical trials in the United States, 402 of which are in Arizona. These trials are heavily regulated by Code of Federal Regulations Parts 50, 54, 56, and 132, which all pertain to the rules and regulations for researching investigational drugs.
Currently in Arizona, a person who knowingly offers, delivers, receives or accepts any rebate, refund, commission, preference or other consideration as compensation for referring a patient to any individual, pharmacy, laboratory, clinic or health care institution providing medical or health-related services is guilty of:
A class 3 felony, if the consideration had a value of $1,000 or more.
A class 4 felony, if the consideration had a value of $100-$1,000 or more.
A class 6 felony, if the consideration had a value of $0-$100 or more.
It is estimated that it costs approximately $300-$500 per year per enrolled patient for a physician to refer and monitor study patients. It is not illegal to reimburse a physician for the time and expense incurred in determining whether a patient qualifies to participate in a research study. However, Arizona Revised Statutes, 13-3713, 32-1401 and 32-1845 currently prohibit payment of referral fees. There is no Federal law that prohibits reimbursements to physicians for referrals to clinical trials.
· Authorizes payments from a medical researcher to a physician in connection with identifying and monitoring patients for a clinical trial regulated by the United States Food and Drug Administration.
· Clarifies that accepting payments from a medical researcher in connection with identifying and monitoring patients for a clinical trial is not an act of “unprofessional conduct” as defined in the physician statutes.
· Makes technical and conforming changes.
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46th Legislature
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Second Regular Session 2 March
30, 2004
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