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.