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ARIZONA STATE SENATE
Fifty-Sixth Legislature, Second Regular Session
AMENDED
forced organ harvesting; insurance; prohibition
Purpose
Allows an insurer and the Arizona Health Care Cost Containment System (AHCCCS) to limit coverage for genetic sequencing, human organ transplants or post-transplant care if the company, operation or organ is associated with a foreign adversary. Establishes prohibitions and requirements for health care institutions and research facilities relating to genetic sequencers and software used for genetic sequencing.
Background
The Department of Insurance and Financial Institutions regulates policies, certificates, evidences of coverage and contracts of insurance (insurance policies) that are issued or delivered by health care insurers. 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 National Organ Transplant Act deems it unlawful for any person to knowingly acquire, receive or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce. A human organ is the human or fetal kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any organ subpart and any other human or fetal organ or subpart specified by the U.S. Secretary of Health and Human Services (42 USC § 274e).
The AG serves as the chief legal officer of Arizona and receives complaints and investigates alleged violations relating to civil rights, consumer fraud and other statutes as authorized (A.R.S. Title 41, Chapter 1, Article 5).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Allows an insurance policy, and AHCCCS subject to approval of the U.S. Centers for Medicare and Medicaid Services, to limit coverage to a member for genetic sequencing if the genetic sequencing is performed on a device that is either:
a) produced by a company domiciled in a foreign adversary; or
b) produced by a company owned or substantially controlled by a company domiciled in a foreign adversary.
2. Allows
an insurance policy, and AHCCCS subject to approval of the U.S. Centers for
Medicare and Medicaid Services, to limit coverage to a member for a human organ
transplant or
post-transplant care if either:
a) the transplant operation is performed in the People's Republic of China or the Hong Kong Special Administrative Region; or
b) the human organ to be transplanted was procured by a sale of donation originating in the People's Republic of China or the Hong Kong Special Administrative Region.
3. Defines foreign adversary as the People's Republic of China, Russia, Iran, North Korea, Cuba, Venezuela or Syria or the Hong Kong Special Administrative Region and includes:
a) a country designated as a foreign adversary by the federal government;
b) any agent or entity under significant control of a foreign adversary; and
c) any country or company that procures organs through forced organ harvesting.
4. Defines forced organ harvesting as either the removal of one or more organs from a living person by means of coercion, abduction, deception, fraud or abuse of power or a position of vulnerability or the removal of organs from a person who was killed for the purpose of removing one or more organs.
5. Prohibits a health care institution or research facility from using genetic sequencers or any operational or research software used for genetic sequencing (sequencers or software) for the purposes of conducting genetic sequencing if the sequencers or software is produced in or by:
a) a foreign adversary or its affiliate;
b) a company, subsidiary or enterprise deemed a Chinese military company or an affiliate pursuant to federal annual publication requirements;
c) a company, subsidiary or enterprise domiciled in a foreign adversary of its affiliate; or
d) a company owned or controlled subsidiary of a company that is domiciled in a foreign adversary of its affiliate.
6. Requires all prohibited sequencers and software that are not permanently disabled to be removed and replaced with non-prohibited sequencers and software.
7. Requires, by December 31, 2025, and annually thereafter, an attorney for the health care institution or research facility to certify in writing that the institution or facility complies with the prohibition on specific certain sequencers.
8. Subjects a health care institution or research facility that spends state monies in violation of the prohibition on specific certain sequencers to a civil penalty of $20,000 for each violation.
9. Specifies that a violation is each instance of an individual's genome having undergone genetic sequencing using prohibited sequencers and software used for genetic sequencers or genetic sequencing.
10. Allows 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 that individual's human genome was processed using prohibited technology.
11. Requires all genetic sequencing data to be stored in the United States and prohibits any remote access of data storage, other than open data, unless approved in writing by the Director of the Department of Health Services.
12. Requires health care institutions and research facilities that store genetic sequencing data, including contracts with third-party data storage companies, to ensure that the data is secured through reasonable encryption method, restriction on access and other cybersecurity measures.
13. Specifies that a document of an anatomical gift is valid if the gift was received lawfully, unless the gift was received from a foreign adversary.
14. Specifies that the authorization to limit coverage for genetic sequencing and organ transplants do not:
a) require coverage for genetic sequencing or human organ transplants; or
b) limit an insurer from denying coverage for any valid reason.
15. Designates this legislation as the Arizona End Organ Harvesting Act.
16. Defines terms.
17. Becomes effective on the general effective date.
Amendments Adopted by Committee
· Makes technical changes.
House Action Senate Action
HHS 2/5/24 DP 7-3-0-0 FICO 3/18/24 DPA 4-3-0
3rd Read 2/29/24 31-28-0-0-1
Prepared by Senate Research
March 19, 2024
MG/cs