86R17487 SMT-F
By: Raymond H.B. No. 317
Substitute the following for H.B. No. 317:
By: Lucio III C.S.H.B. No. 317
A BILL TO BE ENTITLED
AN ACT
relating to the use of clinical decision support software and
laboratory benefits management programs in connection with the
provision of clinical laboratory services to certain managed care
plan enrollees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 1451, Insurance Code, is amended by
adding Subchapter L to read as follows:
SUBCHAPTER L. CLINICAL LABORATORY SERVICES
Sec. 1451.551. DEFINITIONS. In this subchapter:
(1) "Clinical decision support software" means
computer software that compares patient characteristics to a
database of clinical knowledge to produce patient-specific
assessments or recommendations to assist a physician or health care
provider in making clinical decisions.
(2) "Clinical laboratory service" means the
examination of a specimen taken from a human body ordered by a
physician or health care provider for use in the diagnosis,
prevention, or treatment of a disease or the identification or
assessment of a medical or physical condition.
(3) "Enrollee" means an individual enrolled in a
managed care plan.
(4) "Esoteric molecular and genomic testing" means any
test of a patient specimen analyzing multiple biomarkers of
deoxyribonucleic acid, ribonucleic acid, or proteins using a unique
algorithm to yield a patient-specific prognosis or diagnosis.
(5) "Laboratory benefits management program" means a
managed care plan issuer protocol or program administered by the
managed care plan issuer or another entity under contract with the
managed care plan issuer that directs or limits decision making of a
physician or health care provider authorized to order clinical
laboratory services. The term includes a requirement for a
physician or health care provider to provide advance notice of an
order for clinical laboratory services.
(6) "Managed care plan" means a health benefit plan
under which health care services are provided to enrollees through
contracts with physicians or health care providers and that
requires enrollees to use participating providers or that provides
a different level of coverage for enrollees who use participating
providers. The term includes a health benefit plan issued by:
(A) a health maintenance organization;
(B) a preferred or exclusive provider benefit
plan issuer; or
(C) any other entity that issues a health benefit
plan described by this subdivision, including an insurance company.
(7) "National medical consensus guidelines" means
applicable generally accepted practice guidelines that are:
(A) supported by peer-reviewed medical
literature; and
(B) promulgated by the federal government or by a
national professional medical society, board, or association.
(8) "Participating provider" means a physician or
health care provider who has contracted with a managed care plan
issuer to provide services to enrollees.
(9) "Physician" means a person licensed to practice
medicine in this state.
Sec. 1451.552. CERTAIN REQUIREMENTS FOR CLINICAL
LABORATORY SERVICES PROHIBITED; EXCEPTION. (a) Except as provided
by Subsection (d), a managed care plan issuer may not require the
use of clinical decision support software or a laboratory benefits
management program by an enrollee's physician or health care
provider before, at the time, or after the physician or health care
provider orders a clinical laboratory service for the enrollee.
(b) A managed care plan issuer may not direct or limit the
decision making of an enrollee's physician or health care provider
relating to the referral of a patient specimen to a laboratory in
the managed care plan network or a network otherwise designated by
the managed care plan issuer.
(c) A managed care plan issuer may not limit, reduce, or
deny payment for a clinical laboratory service based on whether the
ordering physician or health care provider uses clinical decision
support software or a laboratory benefits management program.
(d) Subsection (a) does not apply to an order for a clinical
laboratory service if the specimen is not obtained in a hospital or
ambulatory surgical center and:
(1) the order is for esoteric molecular and genomic
testing; or
(2) there are national medical consensus guidelines
available for the clinical laboratory service ordered.
Sec. 1451.553. CERTAIN REQUIREMENTS FOR SECOND OPINION
PROHIBITED. A managed care plan issuer may not routinely require a
second opinion of a pathologist's finding from another pathologist
unless the second opinion is medically warranted based on the
specific clinical presentation of the enrollee or other clinical
factors relevant to the enrollee.
Sec. 1451.554. CLINICAL DECISION SUPPORT SOFTWARE AND
LABORATORY BENEFITS MANAGEMENT PROGRAM REQUIREMENTS. (a) A
managed care plan issuer may only use clinical decision support
software or a laboratory benefits management program that:
(1) is transparently based on published,
peer-reviewed medical literature;
(2) is subject to timely and routine updates based on
national medical consensus guidelines and the most current medical
knowledge; and
(3) may be immediately overridden by a physician based
on the physician's medical judgment.
(b) A managed care plan issuer may not use a laboratory
benefits management program that is administered, created, or owned
by an individual or entity with an interest in a clinical laboratory
in the managed care plan network.
Sec. 1451.555. SUPERVISION BY COMPARABLE PROFESSIONAL
REQUIRED. A managed care plan issuer may only use clinical decision
support software, a laboratory benefits management program, or a
prior authorization protocol for clinical laboratory services that
is supervised by a physician of the same or a similar specialty as
the ordering physician or health care provider.
Sec. 1451.556. APPLICABILITY OF SUBCHAPTER TO ENTITIES
CONTRACTING WITH MANAGED CARE PLAN ISSUER. This subchapter applies
to a person with whom a managed care plan issuer contracts to:
(1) manage or administer benefits for clinical
laboratory services;
(2) process or pay claims;
(3) obtain the services of physicians or other health
care providers to provide health care services to enrollees; or
(4) issue verifications or prior authorizations.
Sec. 1451.557. CONSTRUCTION OF SUBCHAPTER. This subchapter
may not be construed to regulate the implementation or
administration of clinical decision support software, a laboratory
benefits management program, or a prior authorization protocol by
an entity, including a health care entity, that is not acting on
behalf of or at the direction of a managed care plan issuer in
adopting the software, program, or protocol.
SECTION 2. Subchapter L, Chapter 1451, Insurance Code, as
added by this Act, applies only to a contract between a managed care
plan issuer and a physician or health care provider that is entered
into or renewed on or after the effective date of this Act. A
contract entered into or renewed before the effective date of this
Act is governed by the law as it existed immediately before the
effective date of this Act, and that law is continued in effect for
that purpose.
SECTION 3. This Act takes effect September 1, 2019.