Current through Register Vol. XLI, No. 38, September 20, 2024
11.1.
To be approved under section 10 to conduct external reviews, an IRO shall have and
maintain written policies and procedures that govern all aspects of both the
standard external review process and the expedited external review process set forth
in this rule that include, at a minimum:
11.1.a. A
quality assurance mechanism in place that:
11.1.a.1. Ensures that external reviews are
conducted within the specified time frames and required notices are provided in a
timely manner;
11.1.a.2. Ensures the
selection of qualified and impartial clinical reviewers to conduct external reviews
on behalf of the IRO and suitable matching of reviewers to specific cases that the
IRO employs or contracts with an adequate number of clinical reviewers to meet this
objective;
11.1.a.3. Ensures the
confidentiality of medical and treatment records and clinical review criteria;
and
11.1.a.4. Ensures that any person
employed by or under contract with the IRO adheres to the requirements of this
rule;
11.1.b. A toll-free
telephone service to receive information on a 24-hour-day, 7-day-a-week basis
related to external reviews that is capable of accepting, recording or providing
appropriate instruction to incoming telephone callers during other than normal
business hours; and
11.1.c. Agree to
maintain and provide to the Commissioner the information set out in section
13.
11.2. All clinical
reviewers assigned by an IRO to conduct external reviews shall be physicians or
other appropriate health care providers who meet the following minimum
qualifications:
11.2.a. Be an expert in the
treatment of the covered person's medical condition that is the subject of the
external review;
11.2.b. Be
knowledgeable about the recommended health care service or treatment through recent
or current actual clinical experience treating patients with the same or similar
medical condition of the covered person;
11.2.c. Hold a non-restricted license in a State
of the United States and, for physicians, a current certification by a recognized
American medical specialty board in the area or areas appropriate to the subject of
the external review; and
11.2.d. Have no
history of disciplinary actions or sanctions, including loss of staff privileges or
participation restrictions, that have been taken or are pending by any hospital,
governmental agency or unit, or regulatory body that raise a substantial question as
to the clinical reviewer's physical, mental or professional competence or moral
character.
11.3. In addition
to the requirements set forth in subsection 11.1, an IRO may not own or control, be
a subsidiary of or in anyway be owned or controlled by, or exercise control with a
health benefit plan, a national, state or local trade association of health benefit
plans, or a national State or local trade association of health care
providers.
11.4.
Conflicts.
11.4.a. In addition to the requirements set forth
in subsections 11.1, 11.2 and 11.3, to be approved pursuant to section 10 to conduct
an external review of a specified case, neither the IRO selected to conduct the
external review nor any clinical reviewer assigned by the independent organization
to conduct the external review may have a material professional, familial or
financial conflict with any of the following:
11.4.a.1. The issuer that is the subject of the
external review;
11.4.a.2. The covered
person whose treatment is the subject of the external review, any known close
relative of the covered person or the covered person's representative;
11.4.a.3. Any officer, director or management
employee of the issuer that is the subject of the external review;
11.4.a.4. Any administrator, fiduciary, employee
or sponsor of an employee welfare benefit plan as defined in
29 U.S.C.
1002(1), if any, under which the
covered person's request for external review arises;
11.4.a.5. A trade association of group health
plans or issuers, or a trade association of health care providers;
11.4.a.6. The health care provider, the health
care provider's medical group or independent practice association recommending the
health care service or treatment that is the subject of the external
review;
11.4.a.7. The facility at which
the recommended health care service or treatment would be provided; or
11.4.a.8. The developer or manufacturer of the
principal drug, device, procedure or other therapy being recommended for the covered
person whose treatment is the subject of the external review.
11.4.b. In determining whether an IRO or a
clinical reviewer of the IRO has a material professional, familial or financial
conflict of interest for purposes of subdivision 11.4.a, the Commissioner may
disregard the mere appearance of a conflict of interest.
11.5. An IRO that is accredited by a nationally
recognized private accrediting entity that has independent review accreditation
standards that the Commissioner has determined are equivalent to or exceed the
minimum qualifications of this section shall be presumed in compliance with this
section to be eligible for approval under section 10.
11.5.a. The Commissioner shall initially review
and periodically review the IRO accreditation standards of a nationally recognized
private accrediting entity to determine whether the entity's standards are, and
continue to be, equivalent to or exceed the minimum qualifications established under
this section. The Commissioner may accept a review conducted by the NAIC for the
purpose of the determination under this paragraph.
11.5.b. Upon request, a nationally recognized
private accrediting entity shall make its current IRO accreditation standards
available to the Commissioner or the NAIC in order for the Commissioner to determine
if the entity's standards are equivalent to or exceed the minimum qualifications
established under this section. The Commissioner may exclude any private accrediting
entity that is not reviewed by the NAIC.
11.6. An IRO shall be unbiased. An IRO shall
establish and maintain written procedures to ensure that it is unbiased in addition
to any other procedures required under this section.
