Current through Reg. 50, No. 13; March 28, 2025
The IRO application form requires information that is
necessary for the commissioner to determine whether an applicant is qualified
for a certificate of registration as an IRO under Insurance Code §
4202.004,
including:
(1) a summary of the
independent review plan that meets the requirements of §
12.201 of this chapter, which must
include:
(A) a summary description of review
criteria and review procedures to be used to determine medical necessity or
appropriateness of health care;
(B)
a summary description of review criteria and review procedures to be used to
determine the experimental or investigational nature of health care;
(C) a certification signed by the IRO's
medical director that the review criteria and review procedures to be applied
in review determinations are established with input from appropriate health
care providers and approved by physicians under §
12.201(3) of
this chapter;
(D) procedures
ensuring that the information regarding the reviewing physicians and providers
is updated under §
12.111(a) of
this chapter to ensure the independence of each health care provider or
physician making review determinations; and
(E) a summary description of criteria and
review procedures to be used by the medical director to conduct quality
assurance audits under §
12.202(c)(2) of
this chapter.
(2) copies
of policies and procedures that ensure that all applicable state and federal
laws to protect the confidentiality of medical records and personal information
are followed. These procedures must comply with §
12.208 of this chapter;
(3) a certification, signed by an officer,
director, or owner of the IRO, that the IRO and any party that performs an IRO
function through contracts and subcontracts will comply with Insurance Code
Chapter 4202 and this chapter. The certification must include a statement that
the IRO is responsible for ensuring that all contracted and subcontracted
functions are performed according to Insurance Code Chapter 4202 and this
chapter, subject to the IRO's oversight and monitoring, and that the IRO
retains ultimate responsibility for compliance;
(4) a description of personnel and their
credentials and a completed profile for each physician and provider, as
described in §
12.202 of this chapter that must
include:
(A) the credentialing and
recredentialing procedures used by the IRO applicant to verify physician and
provider credentials and the computer processes, electronic databases, and
records, if any, used to make the verification; and
(B) the credentialing software used by the
applicant for managing the processes, databases, and records described in
subparagraph (A) of this paragraph;
(5) a description of hours of operation and
how the IRO may be contacted after hours and during weekends and holidays, as
set out in §
12.207 of this chapter;
(6) a description of the applicant's use of
communications, records, and computer processes to manage the independent
review process;
(7) a description
and evidence of accreditation from a nationally recognized accrediting
organization, if any, that imposes requirements for accreditation that are the
same as, substantially similar to, or more stringent than the department's
requirements for a certificate of registration. Evidence of accreditation will
be maintained in the department's file for the IRO applicant, and the applicant
may request expedited approval of the certificate of registration with evidence
of accreditation from a nationally recognized accrediting
organization;
(8) the
organizational information, documents, and all amendments that must include:
(A) written evidence that the applicant is
incorporated in this state, which may include a copy of the Certificate of
Formation from the Texas Secretary of State;
(B) for an applicant that is publicly held,
the name, address, and Federal Employer Identification Number (EIN) of each
stockholder or owner of more than 5 percent of any stock or options;
(C) a chart showing the internal
organizational structure of the applicant's management and administrative
staff;
(D) a chart showing
contractual arrangements of the applicant, including all contracts between the
applicant and any person and all subcontracts with other persons to perform any
business or daily functions of an IRO; and
(E) copies of the contract and subcontract
with any person who will perform IRO functions on behalf of the applicant. All
contracts and subcontracts must include at a minimum:
(i) a provision that the contracted or
subcontracted party will comply with §
12.208 of this chapter;
(ii) a provision that the applicant is
responsible for ensuring that all contracted and subcontracted functions are
performed under Insurance Code Chapter 4202 and this chapter, subject to the
applicant's oversight and monitoring;
(iii) a provision that the applicant retains
ultimate responsibility for compliance; and
(iv) a provision that, on request, the
contracted party will provide the applicant with data necessary for the
applicant to comply with department requests for information about IRO
functions;
(9) the name of any holder of bonds or notes
of the applicant that exceed $100,000;
(10) the name, address, EIN, and type of
business of each corporation or other organization that the applicant controls
or is affiliated with and the nature and extent of the affiliation or control,
and a chart or list clearly identifying the relationships between the applicant
and any affiliates;
(11)
biographical information about officers, directors, and executives, including
information requested in the biographical affidavit as required in §
12.102(b) of
this chapter:
(A) the applicant must submit a
complete set of fingerprints for each director, officer, and executive of the
applicant and for each owner or shareholder of the applicant, or if the
applicant is publicly held, each owner or shareholder of more than 5 percent of
any of the applicant's stock or options as described by Insurance Code §
4202.004(a)(1),
in compliance with §
1.503 and §
1.504 of this title;
(B) the applicant must submit the name and
biographical information for each director, officer, and executive of the
applicant and of any entity listed under paragraph (10) of this section and a
description of any relationship the named individual has that represents
revenue equal to or greater than 5 percent of that individual's total annual
revenue or which represents a holding or investment worth $100,000 or more in
any of the following entities:
(i) a health
benefit plan;
(ii) a health
maintenance organization;
(iv) a utilization review
agent;
(v) a nonprofit health
corporation;
(vii) a health care
provider;
(ix) a group representing any of
the entities described by clauses (i) - (viii) of this subparagraph.
(C) the applicant must identify
any relationship between the applicant and any affiliate or other organization
in which an officer, director, or employee of the applicant holds a 5 percent
or more interest;
(D) the applicant
must submit a list of any currently outstanding loans or contracts to provide
services between the applicant, affiliates, or any other person relating to any
functions performed by or on behalf of the applicant;
(12) documentation from the comptroller
demonstrating the applicant's good standing and right to transact business in
this state;
(13) for an application
for a certificate of registration or renewal of a certificate of registration
as an IRO in this state made on or after July 7, 2015, a sworn statement from
an officer of the organization that:
(A) the
applicant's primary office included on the IRO application form is located and
maintained at a physical address in this state. As a condition of holding a
certificate of registration to conduct the business of independent review in
this state, an IRO must locate and maintain its primary office at a physical
address in this state;
(B) the
primary office is equipped with a computer system capable of:
(i) processing requests for independent
review; and
(ii) accessing all
electronic records related to the review and the independent review
process;
(C) all records
are maintained electronically and will be made available to the department on
request;
(D) in the case of an
office located in a residence, the working office must be located in a room set
aside for independent review business purposes and in a manner to ensure
confidentiality; and
(E) medical
records are maintained according to §
12.208 of this chapter;
(14) the percentage of the
applicant's revenues that are anticipated to be derived from independent
reviews conducted; and
(15) a
disclosure of any enforcement actions related to the provision of medical care
or conducting of medical reviews taken against a person subject to the
fingerprint requirements under §
1.503 and §
1.504 of this title.