Current through Register Vol. 63, No. 9, September 1, 2024
(1) An independent review organization is
subject to the following decision-making standards and procedures:
(a) The independent review process is
intended to be neutral and independent of influence by any affected party or by
state government. The Director of the Department of Consumer and Business
Services may conduct investigations as authorized by law but has no involvement
in the disposition of specific cases.
(b) Independent review is a document review
process. An enrollee, a health plan or an attending provider may not
participate in or attend an independent review in person or obtain
reconsideration of a decision by an independent review organization.
(c) An independent review organization shall
present cases to medical reviewers in a way that maximizes the likelihood of a
clear, unambiguous decision. This may involve stating or restating the
questions for review in a clear and precise manner that encourages yes or no
answers.
(d) An independent review
organization may uphold an adverse determination if the patient or any provider
refuses or fails to provide in a timely manner relevant medical records that
are available and have been requested pursuant to ORS
743B.256. Pursuant to ORS
743B.252, an independent review
organization may overturn an adverse determination if the insurer refuses or
fails to provide in a timely manner relevant medical records that are available
and have been requested.
(e) An
independent review organization must maintain written policies and procedures
covering all aspects of review.
(2) Once the director refers a dispute, the
independent review organization must proceed to a final decision in accordance
with the procedural requirements of ORS
743B.252 and
743B.256 and OAR
836-053-1300 to
836-053-1365 unless requested
otherwise by both the insurer and the enrollee.
(3) An independent review organization must
decide whether or not the dispute pertains to an adverse benefit determination
as described in ORS 743B.252(1). If
the dispute is covered, it is eligible for external review. An independent
review organization must also decide whether the dispute concerns a covered
benefit in the health benefit plan. If the dispute concerns a non-covered
benefit, the dispute does not qualify for external review.
(4) An independent review organization is
subject to the following standards with respect to information to be considered
for reviews:
(a) An independent review
organization must request as necessary and must accept and consider the
following information as relevant to a case referred:
(A) Medical records and other materials that
the insurer is required to submit to the independent review organization under
ORS 743B.252(3),
including information identified in that section that is initially missing or
incomplete as submitted by the insurer.
(B) For cases in which the insurer's decision
addressed whether a course or plan of treatment was medically necessary:
(i) A copy of the definition of medical
necessity from the relevant health insurance policy;
(ii) An explanation of how the insurer's
decision conformed to the definition of medical necessity; and
(iii) An explanation of how the insurer's
decision conformed to the requirement that the definition of medical necessity
be uniformly applied.
(C)
For cases in which the insurer's decision addressed whether a course or plan of
treatment was experimental or investigational:
(i) A copy of the definition of experimental
or investigational from the relevant health insurance policy;
(ii) An explanation of how the insurer's
decision conformed to that definition of experimental or investigational;
and
(iii) An explanation of how the
insurer's decision conformed to the requirement that the definition of
experimental or investigational be uniformly applied.
(D) Other medical, scientific and
cost-effectiveness evidence, as described in section (5) of this rule, that is
relevant to the case.
(b)
After referral of a case, an independent review organization must accept
additional information from the enrollee, the insurer or a provider acting on
behalf of the enrollee at the enrollee's request if the information is
submitted within five business days of the independent review organization
after the enrollee's receipt of notification of the appointment of the
independent review organization or, in the case of an expedited referral,
within 24 hours. The additional information must be related to the case and
relevant to statutory criteria contained in ORS
743B.252.
(c) An independent review organization must
ensure the confidentiality of medical records and other personal health
information received for use in reviews, in accordance with applicable federal
and state laws.
(5) If a
course or plan of treatment is determined to be subject to independent review,
a determination of whether the adverse decision of an insurer should be upheld
or not must be based upon expert clinical judgment, after consideration of
relevant medical, scientific and cost-effectiveness evidence and medical
standards of practice in the United States. As used in this section:
(a) "Medical, scientific, and
cost-effectiveness evidence" means published evidence on results of clinical
practice of any health profession that complies with one or more of the
following requirements:
(A) Peer-reviewed
scientific studies published in or accepted for publication by medical journals
that meet nationally recognized requirements for scientific manuscripts and
that submit most of their published articles for review by experts who are not
part of the editorial staff;
(B)
Peer-reviewed literature, biomedical compendia, and other medical literature
that meet the criteria of the National Institute of Health's National Library
of Medicine for indexing in Index Medicus, Excerpta Medica, Embase, Medline,
Medical Literature Analysis and Retrieval System or Health Services Technology
Assessment Texts;
(C) Medical
journals recognized by the Secretary of Health and Human Services, under
Section 1861(t)(2) of the Social Security Act;
(D) The American Hospital Formulary
Service-Drug Information, the American Medical Association Drug Evaluation, the
American Dental Association Accepted Dental Therapeutics, and the United States
Pharmacopoeia-Drug Information;
(E)
Findings, studies or research conducted by or under the auspices of a federal
government agency or a nationally recognized federal research institute,
including the Federal Agency for Healthcare Research and Quality, National
Institutes of Health, National Cancer Institute, National Academy of Sciences,
Center for Medicaid and Medicare Services, Congressional Office of Technology
Assessment, and any national board recognized by the National Institutes of
Health for the purpose of evaluating the medical value of health
services;
(F) Clinical practice
guidelines that meet Institute of Medicine criteria; or
(G) In conjunction with other evidence,
peer-reviewed abstracts accepted for presentation at major scientific or
clinical meetings.
(b)
Medical standards of practice include the standards appropriately applied to
physicians or other providers or health care professionals, as pertinent to the
case.
(6) The following
standards govern the assignment by an independent review organization of
appropriate medical reviewers to a case:
(a) A
medical reviewer assigned to a case must comply with the conflict of interest
provisions in OAR 836-053-1320.
(b) An independent review organization shall
assign one or more medical reviewers to each case as necessary to meet the
requirements of this subsection. The medical reviewer assigned to a case, or
the medical reviewers assigned to a case together, must meet each of the
following requirements:
(A) Have expertise to
address each of the issues that are the source of the dispute.
(B) Be a clinical peer. For purposes of this
paragraph, a clinical peer is a physician or other medical reviewer who is in
the same or similar specialty that typically manages the medical condition,
procedures or treatment under review. Generally, as a peer in a similar
specialty, the individual must be in the same profession and the same licensure
category as the attending provider. In a profession that has organized,
board-certified specialties, a clinical peer generally will be in the same
formal specialty.
(C) Have the
ability to evaluate alternatives to the proposed treatment.
(c) Each independent review
organization must have a policy specifying the methodology for determining the
number and qualifications of medical reviewers to be assigned to each case. The
number of reviewers shall be governed by the following requirements:
(A) The number of reviewers must reflect the
complexity of the case and the goal of avoiding unnecessary cost.
(B) The independent review organization may
consider, but shall not be bound by, recommendations regarding complexity from
the insurer or attending provider.
(C) The independent review organization shall
consider situations such as review of experimental and investigational
treatments that may benefit from an expanded panel.
(7) An independent review
organization shall notify the enrollee and the insurer of its decision on the
enrollee's case and provide documentation and reasons for the, decision
including the clinical basis for the decision unless the decision is wholly
based on application of coverage provisions.
(a) Documentation of the basis for the
decision shall include references to supporting evidence, and if applicable,
the reasons for any interpretation regarding the application of health benefit
plan coverage provisions, but shall not recommend a course of treatment or
otherwise engage in the practice of medicine.
(b) If the decision overrides the health
benefit plan's standards governing the coverage issues that are subject to
independent review, the reasons shall document why the health benefit plan's
standards are unreasonable or inconsistent with sound, evidence-based medical
practice.
(c) The written report
shall include the qualifications of each medical reviewer but shall not
disclose the identity of the reviewer.
(d) Notification of the decision shall be
provided initially by phone, e-mail or fax, followed by a written report by
mail. In the case of expedited reviews, the initial notification shall be
immediate and by phone, followed by a written report.
(8) An independent review organization's
decision shall be final unless, within seven business days of an enrollee's
receipt of the written report of the independent review organization's
decision, the enrollee submits information to the director that the independent
review organization failed to materially comply with the procedural
requirements of ORS 743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365. If the enrollee is
satisfied with the independent review organization's decision, the enrollee may
notify the independent review organization and insurer by electronic mail, fax
or telephone, followed by a written notice, stating that the enrollee waives
the seven business days before the independent review organization decision is
final.
(9) The director shall
review the information submitted by the enrollee and, within seven business
days, make a written determination whether:
(a) The director is reasonably satisfied that
the independent review organization failed to materially comply with the
procedural requirements of ORS
743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365; and
(b) The independent review organization's
failure to materially comply with the procedural requirements of ORS
743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365 materially affected
the independent review organization's decision.
(10) The director shall send a written
notification of the determination to the enrollee and the independent review
organization. The independent review organization's decision will be final if
the director is reasonably satisfied that the independent review organization
complied with the procedural requirements in ORS
743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365.
(11) If an independent review organization
failed to materially comply with the procedural requirements in ORS
743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365, the independent
review organization shall correct the failure to materially comply by
conducting a new external review, at the independent review organization's
cost, and issuing a new decision within ten business days.
(a) Within 24 hours of receipt of the written
notification from the director described in section (10) of this rule, the
independent review organization shall:
(A)
Notify the enrollee and the insurer via electronic mail, fax or telephone that
the independent review organization will be conducting a new external review,
and
(B) Request from the enrollee
or the insurer via electronic mail or fax any information not already provided
to the independent review organization that is necessary to correct the
material failure to comply with the procedural requirements of ORS
743B.253, or
743B.256 or OAR
836-053-1330 to
836-053-1365.
(12) The enrollee or insurer must provide to
the independent review organization any requested information in section (11)
of this rule within 48 hours after receipt of the request.
(13) Notification of the independent review
organization's new decision shall be provided to the enrollee and insurer
initially via electronic mail, fax or telephone, followed by a written report
by mail.
(14) For the purposes of
sections (8) to (13) of this rule, "procedural requirements" does not include
requirements related to the exercising of medical judgment or decision making
by the independent review organization.
(15) The independent review organization's
decision based on the new external review shall be final as of the date of the
decision.
(16) Except as provided
in this section, an independent review organization shall not disclose the
identity of a medical reviewer unless otherwise required by state or federal
law. The director shall not require reviewers' identities as part of the
contracting process but may examine identified information about reviewers as
part of enforcement activities. The identity of the medical director of an
independent review organization shall be disclosed upon request of any
person.
(17) An independent review
organization shall promptly report to the director any attempt by any party,
including a state agency, to interfere with the carrying out of the independent
review organization's duties under ORS
743B.253 or
743B.256 or OAR
836-053-1300 to
836-053-1365.
(18) An independent review organization must
maintain business hours, methods of contact (including telephone contact),
procedures for after-hours requests and other relevant procedures to ensure
timely availability to conduct expedited as well as regular reviews.
Publications: Publications referenced are available from the
agency.
Statutory/Other Authority: ORS
731.244 & ORS
743B.253
Statutes/Other Implemented: ORS
743B.253, ORS
743B.252 & ORS
743B.256
