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A BILL TO BE ENTITLED
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AN ACT
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relating to the use of clinical decision support software and |
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laboratory benefits management programs in connection with the |
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provision of clinical laboratory services to certain managed care |
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plan enrollees. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 1451, Insurance Code, is amended by |
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adding Subchapter L to read as follows: |
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SUBCHAPTER L. CLINICAL LABORATORY SERVICES |
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Sec. 1451.551. DEFINITIONS. In this subchapter: |
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(1) "Clinical decision support software" means |
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computer software that compares patient characteristics to a |
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database of clinical knowledge to produce patient-specific |
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assessments or recommendations to assist a physician or health care |
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provider in making clinical decisions. |
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(2) "Clinical laboratory service" means the |
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examination of a specimen taken from a human body ordered by a |
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physician or health care provider for use in the diagnosis, |
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prevention, or treatment of a disease or the identification or |
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assessment of a medical or physical condition. |
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(3) "Enrollee" means an individual enrolled in a |
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managed care plan. |
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(4) "Esoteric molecular and genomic testing" means any |
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test of a patient specimen analyzing multiple biomarkers of |
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deoxyribonucleic acid, ribonucleic acid, or proteins using a unique |
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algorithm to yield a patient-specific prognosis or diagnosis. |
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(5) "Laboratory benefits management program" means a |
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managed care plan issuer protocol or program administered by the |
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managed care plan issuer or an entity under contract with the |
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managed care plan issuer that directs or limits decision making of a |
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physician or health care provider authorized to order clinical |
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laboratory services. The term includes a requirement for a |
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physician or health care provider to provide advance notice of an |
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order for clinical laboratory services. |
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(6) "Managed care plan" means a health benefit plan |
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under which health care services are provided to enrollees through |
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contracts with physicians or health care providers and that |
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requires enrollees to use participating providers or that provides |
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a different level of coverage for enrollees who use participating |
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providers. The term includes a health benefit plan issued by: |
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(A) a health maintenance organization; |
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(B) a preferred or exclusive provider benefit |
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plan issuer; or |
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(C) any other entity that issues a health benefit |
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plan described by this subdivision, including an insurance company. |
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(7) "National medical consensus guidelines" means |
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applicable generally accepted practice guidelines that are: |
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(A) supported by peer-reviewed medical |
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literature; and |
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(B) promulgated by the federal government or by a |
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national professional medical society, board, or association. |
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(8) "Participating provider" means a physician or |
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health care provider who has contracted with a managed care plan |
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issuer to provide services to enrollees. |
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(9) "Physician" means a person licensed to practice |
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medicine in this state. |
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Sec. 1451.552. CERTAIN REQUIREMENTS FOR CLINICAL |
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LABORATORY SERVICES PROHIBITED; EXCEPTION. (a) Except as provided |
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by Subsection (d), a managed care plan issuer may not require the |
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use of clinical decision support software or a laboratory benefits |
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management program by an enrollee's physician or health care |
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provider before, at the time, or after the physician or health care |
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provider orders a clinical laboratory service for the enrollee. |
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(b) A managed care plan issuer may not direct or limit the |
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decision making of an enrollee's physician or health care provider |
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relating to the referral of a patient specimen to a laboratory in |
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the managed care plan network or a network otherwise designated by |
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the managed care plan issuer. |
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(c) A managed care plan issuer may not limit, reduce, or |
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deny payment for a clinical laboratory service based on whether the |
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ordering physician or health care provider uses clinical decision |
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support software or a laboratory benefits management program. |
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(d) Subsection (a) does not apply to an order for a clinical |
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laboratory service if the specimen is not obtained in a hospital or |
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ambulatory surgical center and: |
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(1) the order is for esoteric molecular and genomic |
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testing; or |
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(2) there are national medical consensus guidelines |
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available for the clinical laboratory service ordered. |
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Sec. 1451.553. CERTAIN REQUIREMENTS FOR SECOND OPINION |
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PROHIBITED. A managed care plan issuer may not routinely require a |
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second opinion of a pathologist's finding from another pathologist |
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unless the second opinion is medically warranted based on the |
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specific clinical presentation of the enrollee or other clinical |
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factors relevant to the enrollee. |
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Sec. 1451.554. CLINICAL DECISION SUPPORT SOFTWARE AND |
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LABORATORY BENEFITS MANAGEMENT PROGRAM REQUIREMENTS. (a) A |
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managed care plan issuer may only use clinical decision support |
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software or a laboratory benefits management program that: |
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(1) is transparently based on published, |
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peer-reviewed medical literature; |
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(2) is subject to timely and routine updates based on |
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national medical consensus guidelines and the most current medical |
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knowledge; and |
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(3) may be immediately overridden by a physician based |
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on the physician's medical judgment. |
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(b) A managed care plan issuer may not use a laboratory |
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benefits management program that is administered, created, or owned |
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by an individual or entity with an interest in a clinical laboratory |
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in the managed care plan network. |
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Sec. 1451.555. SUPERVISION BY COMPARABLE PROFESSIONAL |
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REQUIRED. A managed care plan issuer may only use clinical decision |
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support software, a laboratory benefits management program, or a |
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prior authorization protocol for clinical laboratory services that |
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is supervised by a physician of the same or a similar specialty as |
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the ordering physician or health care provider. |
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Sec. 1451.556. APPLICABILITY OF SUBCHAPTER TO ENTITIES |
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CONTRACTING WITH MANAGED CARE PLAN ISSUER. This subchapter applies |
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to a person with whom a managed care plan issuer contracts to: |
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(1) manage or administer benefits for clinical |
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laboratory services; |
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(2) process or pay claims; |
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(3) obtain the services of physicians or other health |
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care providers to provide health care services to enrollees; or |
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(4) issue verifications or prior authorizations. |
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Sec. 1451.557. CONSTRUCTION OF SUBCHAPTER. This subchapter |
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may not be construed to regulate the implementation or |
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administration of clinical decision support software, a laboratory |
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benefits management program, or a prior authorization protocol by |
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an entity, including a health care entity, that is not acting on |
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behalf of or at the direction of a managed care plan issuer in |
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adopting the software, program, or protocol. |
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SECTION 2. Subchapter L, Chapter 1451, Insurance Code, as |
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added by this Act, applies only to a contract between a managed care |
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plan issuer and a physician or health care provider that is entered |
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into or renewed on or after the effective date of this Act. A |
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contract entered into or renewed before the effective date of this |
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Act is governed by the law as it existed immediately before the |
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effective date of this Act, and that law is continued in effect for |
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that purpose. |
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SECTION 3. This Act takes effect September 1, 2021. |