Current through Register Vol. XLI, No. 38, September 20, 2024
8.1. Within four months
after the date of receipt of a notice of an adverse determination or final adverse
determination that involves a denial of coverage based on a determination that the
health care service or treatment recommended or requested is experimental or
investigational, a covered person may file a request for external review with the
Commissioner.
8.2. A covered person may
make an oral request for an expedited external review of the adverse determination
or final adverse determination pursuant to subsection 8.1 if the covered person's
treating physician certifies, in writing, that the recommended or requested health
care service or treatment that is the subject of the request would be significantly
less effective if not promptly initiated. Such a request shall be handled in
accordance with the procedure set forth in subsections 7.2 through and including
7.8.
8.3. Except for a request for
expedited external review made pursuant to subsection 8.2, the Commissioner shall
notify the issuer of any request made pursuant subsection 8.1 within one business
day after the date of receipt of such request.
8.4. Within six business days following receipt of
a copy of a covered person's external review request from the Commissioner pursuant
to subsection 8.3, the issuer shall send the Commissioner and the covered person its
determination whether the request is complete and if it is eligible for external
review; such determination shall be based on consideration on the following:
8.4.a. The individual is or was a covered person
in the health benefit plan at the time the health care service or treatment was
recommended or requested or, in the case of a retrospective review, was a covered
person in the health benefit plan at the time the health care service or treatment
was provided;
8.4.b. The recommended or
requested health care service or treatment that is the subject of the adverse
determination or final adverse determination:
8.4.b.1. Is a covered benefit under the covered
person's health benefit plan except for the issuer's determination that the service
or treatment is experimental or investigational for a particular medical condition;
and
8.4.b.2. Is not explicitly listed as
an excluded benefit under the covered person's health benefit plan with the
issuer;
8.4.c. The covered
person's treating physician has certified that one of the following situations is
applicable:
8.4.c.1. Standard health care services
or treatments have not been effective in improving the condition of the covered
person;
8.4.c.2. Standard health care
services or treatments are not medically appropriate for the covered person;
or
8.4.c.3. There is no available
standard health care service or treatment covered by the issuer that is more
beneficial than the recommended or requested health care service or treatment
described in subdivision 8.4.d;
8.4.d. The covered person's treating physician:
8.4.d.1. Has recommended a health care service or
treatment that the physician certifies, in writing, is likely to be more beneficial
to the covered person, in the physician's opinion, than any available standard
health care services or treatments; or
8.4.d.2. Who is licensed, board certified or board
eligible physician qualified to practice in the area of medicine appropriate to
treat the covered person's condition, has certified in writing that scientifically
valid studies using accepted protocols demonstrate that the health care service or
treatment requested by the covered person that is the subject of the adverse
determination or final adverse determination is likely to be more beneficial to the
covered person than any available standard health care services or
treatments;
8.4.e. The
covered person is deemed to have exhausted the issuer's internal grievance process
as set forth in W.Va. Code of St. R. §114-95; and
8.4.f. The covered person has provided all the
information and forms required by the Commissioner that are necessary to process an
external review.
8.5. After
the issuer has completed its review pursuant to subsection 8.4, the request for
external review shall thereafter proceed according to the provisions of subsections
6.3 through and including 6.9.
8.5.a. Within one
business day after the receipt of the notice of assignment to conduct the external
review pursuant to subsection 8.5, the assigned IRO shall:
8.5.a.1. Select one or more clinical reviewers, as
it determines is appropriate, pursuant to subdivision 8.5.b to conduct the external
review; and
8.5.a.2. Based on the
opinion of the clinical review, or opinions if more than one clinical reviewer has
been selected to conduct the external review, make decision to uphold or reverse the
adverse determination or final adverse determination.
8.5.b. In selecting clinical reviewers pursuant to
subdivision 8.5.a, the assigned IRO shall select physicians or other health care
professionals who meet the minimum qualifications described in section 11 and,
through clinical experience in the past three years, are experts in the treatment of
the covered person's condition and knowledgeable about the recommended or requested
health care service or treatment. Neither the covered person, the covered person's
authorized representative, if applicable, nor the issuer shall choose or control the
choice of the physicians or other health care professionals to be selected to
conduct the external review.
8.5.c. In
accordance with subsection 8.9, each clinical reviewer shall provide a written
opinion to the assigned IRO on whether the recommended or requested health care
service or treatment should be covered.
8.5.d. In reaching an opinion, clinical reviewers
are not bound by any decisions or conclusions reached during the issuer's
utilization review process as set forth in W.Va. Code of St. R. §114-95 or the
issuer's internal grievance process as set forth W.Va. Code of St. R.
§114-96.
8.6. Within
five business days after the date of receipt of the notice provided pursuant to
subdivision 8.5.a., the issuer or its designee utilization review organization shall
provide to the assigned IRO the documents and any information considered in making
the adverse determination or the final adverse determination.
8.6.a. Except as provided in subdivision 8.6.b,
failure by the issuer or its designee utilization review organization to provide the
documents and information within the time specified in subsection 8.6 may not delay
the conduct of the external review.
8.6.b. If the issuer or its designee utilization
review organization has failed to provide the documents and information within the
time specified in subsection 8.6, the assigned IRO may terminate the external review
and make a decision to reverse the adverse determination or final adverse
determination. Immediately upon making the decision, the IRO shall notify the
covered person, the issuer and the Commissioner.
8.7. Each clinical reviewer selected pursuant to
subsection 8.5 shall review all of the information and documents received pursuant
to subsection 8.6 and any other information submitted in writing by the covered
person. Upon receipt of any information submitted by the covered person pursuant to
subdivision 6.5.a and subsection 8.5, within one business day after the receipt of
the information, the assigned IRO shall forward the information to the
issuer.
8.8. Upon receipt of the
information required to be forwarded pursuant to subsection 8.6, the issuer may
reconsider its adverse determination or final adverse determination that is the
subject of the external review. Reconsideration by the issuer of its adverse
determination or final adverse determination of this subsection may not delay or
terminate the external review.
8.8.a. The external
review may be terminated only if the issuer decides, upon completion of its
reconsideration, to reverse its adverse determination or final adverse determination
and provide coverage or payment for the recommended or requested health care service
or treatment that is the subject of the adverse determination or final adverse
determination.
8.8.b. Immediately upon
making the decision to reverse its adverse determination or final adverse
determination, as provided in subdivision 8.8.a, the issuer shall notify the covered
person, the assigned IRO, and the Commissioner in writing of its decision. The
assigned IRO shall terminate the external review upon receipt of the notice from the
issuer.
8.9. Except as
provided in subdivision 8.9.b, within twenty days after being selected in accordance
with subsection 8.5 to conduct the external review, each clinical reviewer shall
provide an opinion to the assigned IRO pursuant to subsection 8.10 on whether the
recommended or requested health care service or treatment should be covered.
8.9.a. Except for an opinion provided pursuant to
subdivision 8.9.b, each clinical reviewer's opinion shall be in writing and include
the following information:
8.9.a.1. A description
of the covered person's medical condition;
8.9.a.2. A description of the indicators relevant
to determining whether there is sufficient evidence to demonstrate that the
recommended or requested health care service or treatment is more likely than not to
be beneficial to the covered person than any available standard health care service
or treatments and the adverse risks of the recommended or requested health care
services or treatments would not be substantially increased over those of available
standard health care services or treatments;
8.9.a.3. A description and analysis of any medical
or scientific evidence, as that term is defined in subsection 2.24.
8.9.a.4. A description and analysis of any
evidence-based standard, as that term is defined in subsection 2.14.
8.9.a.5. Information on whether the reviewer's
rational for the opinion is based on paragraphs 8.10.e.1 or 8.10.e.2.
8.9.b. For an expedited external
review, each clinical reviewer shall provide an opinion orally or in writing to the
assigned IRO as expeditiously as the covered person's medical condition or
circumstances requires, but in no event more than five calendar days after being
selected in accordance with subsection 8.5. If the opinion provided was not in
writing, within forty-eight hours following the date the opinion was provided, the
clinical reviewer shall provide written confirmation of the opinion to the assigned
IRO and include the information required under subdivision 8.9.a.
8.10. In addition to the documents and
information provided pursuant to subsection 8.2 or subsection 8.6, each clinical
reviewer selected pursuant to subsection 8.5, to the extent the information or
documents are available and the reviewer considers appropriate, shall consider the
following in reaching an opinion pursuant to subsection 8.9:
8.10.a. The covered person's pertinent medical
records;
8.10.b. The attending physician
or health care professional's recommendation;
8.10.c. Consulting reports from appropriate health
care professionals and other documents submitted by the issuer, covered person, the
covered person's authorized representative, or the covered person's treating
physician or health care professional;
8.10.d. The terms of coverage under the covered
person's health benefit plan with the issuer to ensure that, but for the issuer's
determination that the recommended or requested health care service or treatment
that is subject of the opinion is experimental or investigational, the reviewer's
opinion is not contrary to the terms of coverage under the covered person's health
benefit plan with the issuer; and
8.10.e. Whether:
8.10.e.1. The recommended or requested health care
service or treatment has been approved by the federal Food and Drug Administration,
if applicable, for the condition; or
8.10.e.2. Medical or scientific evidence or
evidence-based standards demonstrate that the expected benefits of the recommended
or requested health care service or treatment is more likely than not to be
beneficial to the covered person that any available standard health care service or
treatment and the adverse risks of the recommended or requested health care service
or treatment would not be substantially increased over those of available standard
health care services or treatments.
8.11.
Decisions.
8.11.a. Except as provided in 8.11.b, within
twenty days after the date it receives the opinion of each clinical reviewer
pursuant to subsection 8.9, the assigned IRO, in accordance with subdivision 8.11.d,
shall make a decision and provide written notice of the decision to:
8.11.a.1. The covered person;
8.11.a.2. If applicable, the covered person's
authorized representative;
8.11.a.3. The
issuer; and
8.11.a.4. The
Commissioner.
8.11.b. For an
expedited external review, within forty-eight hours after the date it receives the
opinion of each clinical reviewer pursuant to subsection 8.9, the assigned IRO, in
accordance with subdivision 8.11 .d, shall make a decision and provide notice of the
decision orally or in writing to the persons listed in subdivision 8.11.a.
8.11.c. If the notice provided under subdivision
8.11.b was not in writing, within forty-eight hours after the date of providing that
notice, the assigned IRO shall provide written confirmation of the decision to the
persons listed in subdivision 8.11.a and include the information set forth in
subdivision 8.11.e.
8.11.d. If a
majority of the clinical reviewers recommend that the recommended or requested
health care service or treatment should be covered, the IRO shall make a decision to
reverse the issuer's adverse determination or final adverse determination. If a
majority of the clinical reviewers recommend that the recommended or requested
health care service should not be covered , the IRO shall make a decision to uphold
the issuer's adverse determination or final adverse determination.
8.11.d.1. If the clinical reviewers are evenly
split as to whether the recommended or requested healthcare service or treatment
should be covered, the IRO shall obtain the opinion of an additional clinical
reviewer in order for the IRO to make a decision based on the opinions of a majority
of the clinical reviewers pursuant to this subdivision.
8.11.d.2. The additional clinical reviewer
selected under paragraph 8.11.d.1 shall use the same information to reach an opinion
as the clinical reviewers who have already submitted their opinions pursuant to
subsection 8.9.
8.11.d.3. The selection
of the additional clinical reviewer under this paragraph shall not extend the time
within which the assigned IRO is required to make a decision based on the opinions
of the clinical reviewers selected under subsection 8.5.
8.11.e. The IRO shall include in the notice
provided pursuant to subdivision 8.11.a:
8.11.e.1.
A general description of the reason for the request for external review;
8.11.e.2. The written opinion of each clinical
reviewer, including the recommendation of each clinical reviewer as to whether the
recommended or requested health care service or treatment should be covered and the
rationale for the reviewer's recommendation;
8.11.e.3. The date the IRO was assigned by the
Commissioner to conduct the external review;
8.11.e.4. The date the external review was
conducted;
8.11.e.5. The date of its
decision;
8.11.e.6. The principal reason
or reasons for its decision; and
8.11.e.7. The rationale for its
decision.
8.11.f Upon receipt
of a notice of a decision pursuant to subdivision 8.11.a reversing the adverse
determination or final adverse determination, the issuer immediately shall approve
coverage of the recommended or requested health care service or treatment that was
the subject of the adverse determination or final adverse
determination.
8.12. The
assignment by the Commissioner of an approved IRO to conduct an external review in
accordance with this section shall be done on a random basis among those approved
IROs qualified to conduct the particular external review based on the nature of the
health care service that is the subject of the adverse determination or final
adverse determination and other circumstances, including conflict of interest
concerns pursuant to subsection 11.4.
