ARIZONA HOUSE OF REPRESENTATIVES

Fifty-seventh Legislature

First Regular Session

House: HHS DP 9-3-0-0

HB 2693: genetic sequencing; insurance; prohibition

Sponsor: Representative Biasiucci, LD 30

Caucus & COW

Overview

Establishes insurance coverage and Arizona Health Care Cost Containment System (AHCCCS) limitations on genetic sequencing. Outlines prohibitions and requirements for health care institutions and research facilities relating to genetic sequencers and software used for genetic sequencing.

History

Health care insurers include disability insurers, group disability insurers, blanket disability insurers, health care services organizations, hospital service corporations and medical service corporations (insurers) (A.R.S. § 20-1379). AHCCCS contracts with health professionals to provide medically necessary health and medical services to eligible members, including inpatient and outpatient health services and early and periodic health screening and diagnostic services (A.R.S. § 36-2907). The Department of Insurance and Financial Institutions regulates policies, certificates, evidence of coverage and contracts of insurance (insurance policies) that are issued or delivered by health care insurers.

A health care institution is every place, institution, building or agency, whether organized for profit or not, that provides facilities with medical services, nursing services, behavioral health services, health screening services, other health-related services, supervisory care services, personal care services or directed care services and includes home health agencies, outdoor behavioral health care programs and hospice service agencies (A.R.S. § 36-401).

Provisions

1.   ☐ Prop 105 (45 votes) ☐ Prop 108 (40 votes) ☐ Emergency (40 votes) ☐ Fiscal NoteAllows an insurance policy and AHCCCS, subject to approval of the U.S. Centers for Medicare and Medicaid Services, to limit coverage to a subscriber, enrollee, insured or member for genetic sequencing if the genetic sequencing is performed on a device that is either:

a)   produced by a company that is domiciled in a foreign adversary; or

b)   produced by a company owned or substantially controlled by a company that is domiciled in a foreign adversary. (Sec. 1-4 and 6)

2.   Clarifies that the coverage limitations for genetic sequencing do not:

a)   require coverage for genetic sequencing; or

b) limit an insurer or AHCCCS from denying coverage for any valid reason.                        (Sec. 1-4 and 6)

3.   Prohibits a health care institution or research facility from using genetic sequencers or any operational or research software used for genetic sequencing for the purposes of conducting genetic sequencing if the genetic sequencers or research software is produced in or by any of the following:

a)   a foreign adversary or its affiliate subsidiary or company;

b)   a company, subsidiary or enterprise that is deemed a Chinese military company or an affiliate pursuant to the federal annual publication requirements;

c) a company, subsidiary or enterprise domiciled within a foreign adversary or its affiliate; or

d)   a company owned or controlled subsidiary of a company that is domiciled in a foreign adversary or its affiliates. (Sec. 5)

4.   Requires all prohibited genetic sequencers and operational or research software that are not permanently disabled to be removed and replaced with non-prohibited genetic sequencers and software. (Sec. 5)

5.   Requires by December 31, 2026, and annually thereafter, an attorney for the health care institution or research facility to certify in writing that the health care institution or research facility is in compliance with the genetic sequencing prohibitions. (Sec. 5)

6.   Asserts that a health care institution or research facility that spends state monies in violation of these requirements is subject to a civil penalty of $20,000 per violation.       (Sec. 5)      

7.   Permits any individual to notify the Attorney General of a violation or suspected violation and the following apply:

a)   if the notifying individual is an employee of the health care institution or research facility, the employee has whistleblower protection; and

b)   if the notifying individual is a patient or research subject and the provider of the human genome used in violation, that individual is entitled to recover statutory damages of at least $1,000 for each instance in which the individual's human genome was processed using prohibited technology. (Sec. 5)

8.   Requires all genetic sequencing data to be stored in the United States. (Sec. 5)

9.   Prohibits any remote access of data storage, other than open data, unless approved in writing by the Director of the Arizona Department of Health Services. (Sec. 5)

10.  Requires health care institutions and research facilities that store genetic sequencing, including through contracts with third-party data storage companies to ensure that the data is secured through reasonable encryption methods, restriction on access and other cybersecurity methods. (Sec. 5)

11.  Defines the following terms:

a)   company;

b)   domiciled;

c) foreign adversary;

d)   genetic sequencing; and

e)   violations. (Sec. 1-6)

 

 

 

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                  HB 2693

Initials AG/AB    Page 0 Caucus & COW

 

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