|(a) Review of utilization review plan. The utilization
review plan must be reviewed and approved by a physician licensed
to practice medicine in Texas and conducted under standards developed
and periodically updated with input from both primary and specialty
physicians, doctors, and other health care providers, as appropriate.
(b) Special circumstances.
(1) A utilization review determination must be made
in a manner that takes into account special circumstances of the case
that may require deviation from the norm stated in the screening criteria
or relevant guidelines. Special circumstances include, but are not
limited to, an individual who has a disability, acute condition, or
(2) If coverage is available for stage-four advanced,
metastatic cancer and associated conditions, as defined by Insurance
Code §1369.211, the URA cannot require, before coverage of a
prescription drug, that the enrollee:
(A) fail to successfully respond to a different drug;
(B) prove a history of failure of a different drug.
(3) Paragraph (2) of this subsection only applies to
a drug the use of which is:
(A) consistent with best practices for the treatment
of stage-four advanced, metastatic cancer or an associated condition,
as defined by Insurance Code §1369.211;
(B) supported by peer-reviewed, evidence-based literature;
(C) approved by the United States Food and Drug Administration.
(c) Screening criteria. Each URA must utilize written
screening criteria that are evidence based, scientifically valid,
outcome focused, and that comply with the requirements in Insurance
Code §4201.153. The screening criteria must also recognize that
if evidence-based medicine is not available for a particular health
care service provided, the URA must utilize generally accepted standards
of medical practice recognized in the medical community.
(d) Referral and determination of adverse determinations.
Adverse determinations must be referred to and may only be determined
by an appropriate physician, doctor, or other health care provider
with appropriate credentials under §19.1706 of this title (relating
to Requirements and Prohibitions Relating to Personnel) to determine
the medical necessity, the appropriateness, or the experimental or
investigational nature of health care services.
(e) Delegation of review. A URA, including a specialty
URA, may delegate the utilization review to qualified personnel in
a hospital or other health care facility in which the health care
services to be reviewed were, or are, to be provided. The delegation
does not relieve the URA of full responsibility for compliance with
this subchapter and Insurance Code Chapter 4201, including the conduct
of those to whom utilization review has been delegated.
(f) Complaint system. The URA must develop and implement
procedures for the resolution of oral or written complaints initiated
by enrollees, individuals acting on behalf of the enrollee, or health
care providers concerning the utilization review. The URA must maintain
records of complaints for three years from the date the complaints
are filed. The complaints procedure must include a requirement for
a written response to the complainant by the agent within 30 calendar
days. The written response must include TDI's address, toll-free telephone
number, and a statement explaining that a complainant is entitled
to file a complaint with TDI.