HB 2144 — health insurance coverage; biomarker testing

HouseSenate Engrossed House Bill health insurance coverage;

biomarker testing State of Arizona House of Representatives Fifty-fifth Legislature Second Regular Session CHAPTER 219 HOUSE BILL 2144 AN ACT AMENDING TITLE 20, CHAPTER 4, ARTICLE 3, ARIZONA REVISED STATUTES, BY ADDING SECTION 20-841.13;

A SUBSCRIPTION CONTRACT SHALL COVER BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF A SUBSCRIBER'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST ISPROVIDES SUPPORTEDCLINICAL UTILITY AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING:

"CLINICAL UTILITY" MEANS THE TEST RESULT PROVIDES INFORMATION THAT IS USED IN THE FORMULATION OF A TREATMENT OR MONITORING STRATEGY THAT INFORMS A PATIENT’S OUTCOME AND IMPACTS THE CLINICAL DECISION.

THE MOST APPROPRIATE TEST MAY INCLUDE BOTH INFORMATION THAT IS ACTIONABLE AND SOME INFORMATION THAT CANNOT BE IMMEDIATELY USED IN THE FORMULATION OF A CLINICAL DECISION.

4.

4.5.

AN EVIDENCE OF COVERAGE SHALL COVER BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF AN ENROLLEE'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST ISPROVIDES SUPPORTEDCLINICAL UTILITY AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING:

D.- 2 - H.B.

2144 D.

THE PROCESS SHALL BE READILY ACCESSIBLE ON THE HEALTH CARE SERVICES ORGANIZATION'S WEBSITE.

-E. 2 - H.B.

2144 E.

"CLINICAL UTILITY" MEANS THE TEST RESULT PROVIDES INFORMATION THAT IS USED IN THE FORMULATION OF A TREATMENT OR MONITORING STRATEGY THAT INFORMS A PATIENT’S OUTCOME AND IMPACTS THE CLINICAL DECISION.

THE MOST APPROPRIATE TEST MAY INCLUDE BOTH INFORMATION THAT IS ACTIONABLE AND SOME INFORMATION THAT CANNOT BE IMMEDIATELY USED IN THE FORMULATION OF A CLINICAL DECISION.

4.

4.5.

Sec.- 3 - H.B.

2144 Sec.

A POLICY SHALL COVER BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF AN INSURED'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST ISPROVIDES SUPPORTEDCLINICAL UTILITY AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING:

-3. 3 - H.B.

2144 3.

"CLINICAL UTILITY" MEANS THE TEST RESULT PROVIDES INFORMATION THAT IS USED IN THE FORMULATION OF A TREATMENT OR MONITORING STRATEGY THAT INFORMS A PATIENT’S OUTCOME AND IMPACTS THE CLINICAL DECISION.

THE MOST APPROPRIATE TEST MAY INCLUDE BOTH INFORMATION THAT IS ACTIONABLE AND SOME - 4 - H.B.

2144 INFORMATION THAT CANNOT BE IMMEDIATELY USED IN THE FORMULATION OF A CLINICAL DECISION.

4.

4.5.

-B. 4 - H.B.

2144A B.POLICY SHALL COVER BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF AN INSURED'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST PROVIDES CLINICAL UTILITY AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING:

A POLICY SHALL COVER BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF A SUBSCRIBER'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST IS SUPPORTED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING:

THE SUBSCRIBERINSURED AND PRESCRIBING PRACTITIONER MUST HAVE ACCESS TO A CLEAR, READILY ACCESSIBLE AND CONVENIENT PROCESS TO REQUEST AN EXCEPTION TO A COVERAGE POLICY OF A GROUP OR BLANKET DISABILITY INSURER.

THIS SUBSECTION DOES NOT REQUIRE A SEPARATE PROCESS IF THE- GROUP5 OR- BLANKETH.B. DISABILITY INSURER'S EXISTING PROCESS COMPLIES WITH THIS SUBSECTION.

2144 THE GROUP OR BLANKET DISABILITY INSURER'S EXISTING PROCESS COMPLIES WITH THIS SUBSECTION.

"CLINICAL UTILITY" MEANS THE TEST RESULT PROVIDES INFORMATION THAT IS USED IN THE FORMULATION OF A TREATMENT OR MONITORING STRATEGY THAT INFORMS A PATIENT’S OUTCOME AND IMPACTS THE CLINICAL DECISION.

THE MOST APPROPRIATE TEST MAY INCLUDE BOTH INFORMATION THAT IS ACTIONABLE AND SOME INFORMATION THAT CANNOT BE IMMEDIATELY USED IN THE FORMULATION OF A CLINICAL DECISION.

4.

4.5.

-(a) 5ARE -DEVELOPED H.B.BY INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES USING A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND A CONFLICT OF INTEREST POLICY.

2144 (a) ARE DEVELOPED BY INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES USING A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND A CONFLICT OF INTEREST POLICY.

THE ADMINISTRATION AND ITS CONTRACTORS SHALL PROVIDE BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT OR ONGOING MONITORING OF A MEMBER'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS WHEN THE TEST ISPROVIDES SUPPORTEDCLINICAL UTILITY AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING ANY OF THE FOLLOWING: