Thursday, March 5, 2015

Arizona HB2645 Direct Access testing.

Note:  Some FDA IVD test approvals require the test to be ordered by a physician, which would ?likely supersede state law.  For a news article, see here.

Accessed 03/05/2015.

http://www.azleg.gov/legtext/52leg/1r/bills/hb2645p.htm

HB 2645

Introduced by
Representative Carter


AN ACT

AMENDING SECTION 36‑466, ARIZONA REVISED STATUTES; AMENDING TITLE 36, CHAPTER 4.1, ARTICLE 2, ARIZONA REVISED STATUTES, BY ADDING SECTION 36‑468; RELATING TO CLINICAL LABORATORIES.

(TEXT OF BILL BEGINS ON NEXT PAGE)



Be it enacted by the Legislature of the State of Arizona:
Section 1.  Section 36-466, Arizona Revised Statutes, is amended to read:
36-466.  Advisory committee on clinical laboratories; membership; duties
A.  The advisory committee on clinical laboratories is established consisting of the following members:
1.  Four physicians who are licensed pursuant to title 32, chapter 13 or 17 and who are actively engaged in the practice of medicine.  The director shall appoint these members.
2.  Two physicians who are licensed pursuant to title 32, chapter 13 or 17 and who are employed by a clinical laboratory as pathologists.  The director shall appoint these members.
3.  The director or the director's designee.
B.  The committee shall:
1.  Annually select a chairperson and vice‑chairperson from among its members.
2.  Advise the department in developing a list of direct access tests. The department shall make the list of direct access tests available to the public.
3.  2.  Advise the department on the use and renewal of standing orders.
4.  3.  Conduct regular meetings at the call of the chairperson or a majority of the committee members.
C.  The department's designation of a test as a direct access test does not require that the test be covered by a health insurance plan or product pursuant to title 20 or by any program administered by the Arizona health care cost containment system administration pursuant to chapter 29 of this title.
D.  C.  The department shall adopt rules based on the recommendations of the advisory committee.
E.  D.  Committee members are not eligible to receive compensation or reimbursement of expenses.
F.  E.  The department shall provide necessary staff services to the committee.
G.  F.  The appointed committee members serve three‑year terms.
H.  For the purposes of this section, "direct access tests" means tests that may be obtained without a physician referral including tests that have been granted waived status under the federal clinical laboratory improvement amendments of 1988 (P.L. 100‑518).  Direct access tests do not include tests that are required to be reported to this state for public health and safety reasons.
Sec. 2.  Title 36, chapter 4.1, article 2, Arizona Revised Statutes, is amended by adding section 36-468, to read:

36-468.  Laboratory testing without physician order; results; report; immunity; definition

A.  A PERSON MAY OBTAIN ANY LABORATORY TEST WITHOUT A PHYSICIAN'S REQUEST OR WRITTEN AUTHORIZATION.

B.  IF A LABORATORY TEST OF A PERSON IS CONDUCTED BY OR UNDER THE SUPERVISION OF A PERSON OTHER THAN A PHYSICIAN AND NOT AT THE REQUEST OR WITH THE WRITTEN AUTHORIZATION OF A PHYSICIAN, ANY REPORT OF THE TEST RESULTS SHALL BE PROVIDED BY THE PERSON CONDUCTING THE TEST TO THE PERSON WHO WAS THE SUBJECT OF THE TEST.  THE REPORT SHALL STATE IN BOLD TYPE THAT IT IS THE RESPONSIBILITY OF THE PERSON WHO WAS TESTED TO ARRANGE WITH THE PERSON'S PHYSICIAN FOR CONSULTATION AND INTERPRETATION OF THE TEST RESULTS.

C.  A PHYSICIAN IS NOT LIABLE FOR THE FAILURE TO REVIEW OR ACT ON THE LABORATORY TEST RESULTS OF ANY PATIENT IF THE PHYSICIAN NEITHER REQUESTED NOR AUTHORIZED THE LABORATORY TEST.

D.   THIS SECTION DOES NOT REQUIRE THAT A LABORATORY TEST BE COVERED BY A HEALTH INSURANCE PLAN OR PRODUCT PURSUANT TO TITLE 20 OR BY ANY PROGRAM ADMINISTERED BY THE ARIZONA HEALTH CARE COST CONTAINMENT SYSTEM ADMINISTRATION PURSUANT TO CHAPTER 29 OF THIS TITLE.

E.  FOR THE PURPOSES OF THIS SECTION, "PHYSICIAN" MEANS A PERSON WHO IS LICENSED PURSUANT TO TITLE 32, CHAPTER 13 OR 17.


Sec. 3.  Rulemaking; exemption
The department of health services shall amend or adopt rules to address the changes in direct access laboratory testing as enacted by this act.  For this purpose, the department is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, for one year after the effective date of this act.

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