19 Miss. Code. R. 3-15.09 - External Review of Experimental or Investigational Treatment Adverse Determinations
A.
1. Within four (4) months after the date of
receipt of a notice of an adverse determination or final adverse determination
pursuant to Rule 15.04 of this Regulation 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 or the
covered person's authorized representative may file a request for external
review with the Commissioner.
2.
a. A covered person or the covered person's
authorized representative may make an oral request for an expedited external
review of the adverse determination or final adverse determination pursuant to
paragraph (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.
b. Upon receipt of a
request for an expedited external review, the Commissioner immediately shall
notify the health carrier.
c.
i. Upon notice of the request for expedited
external review, the health carrier immediately shall determine whether the
request meets the reviewability requirements of subsection B. The health
carrier shall immediately notify the Commissioner and the covered person and,
if applicable, the covered person's authorized representative of its
eligibility determination.
ii. The
Commissioner may specify the form for the health carrier's notice of initial
determination under item (i) and any supporting information to be included in
the notice.
iii. The notice of
initial determination under item (i) shall include a statement informing the
covered person and, if applicable, the covered person's authorized
representative that a health carrier's initial determination that the external
review request is ineligible for review may be appealed to the
Commissioner.
d.
i. The Commissioner may determine that a
request is eligible for external review under subsection B(2) notwithstanding a
health carrier's initial determination the request is ineligible and require
that it be referred for external review.
ii. In making a determination under item (i),
the Commissioner's decision shall be made in accordance with the terms of the
covered person's health benefit plan and shall be subject to all applicable
provisions of this Regulation.
e. Upon receipt of the notice that the
expedited external review request meets the reviewability requirements of
subsection B(2), the Commissioner immediately shall assign an independent
review organization to review the expedited request from the list of approved
independent review organizations compiled and maintained by the Commissioner
pursuant to Rule 15.11 of this Regulation and notify the health carrier of the
name of the assigned independent review organization.
f. At the time the health carrier receives
the notice of the assigned independent review organization pursuant to
subparagraph (e) of this paragraph, the health carrier or its designee
utilization review organization shall provide or transmit all necessary
documents and information considered in making the adverse determination or
final adverse determination to the assigned independent review organization
electronically or by telephone or facsimile or any other available expeditious
method.
B.
1. Except for a request for an expedited
external review made pursuant to subsection A(2), within one (1) business day
after the date of receipt of the request, the Commissioner receives a request
for an external review, the Commissioner shall notify the health
carrier.
2. Within five (5)
business days following the date of receipt of the notice sent pursuant to
paragraph (1), the health carrier shall conduct and complete a preliminary
review of the request to determine whether:
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;
b. The
recommended or requested health care service or treatment that is the subject
of the adverse determination or final adverse determination:
i. Is a covered benefit under the covered
person's health benefit plan except for the health carrier's determination that
the service or treatment is experimental or investigational for a particular
medical condition; and
ii. Is not
explicitly listed as an excluded benefit under the covered person's health
benefit plan with the health carrier;
c. The covered person's treating physician
has certified that one of the following situations is applicable:
i. Standard health care services or
treatments have not been effective in improving the condition of the covered
person;
ii. Standard health care
services or treatments are not medically appropriate for the covered person; or
iii. There is no available
standard health care service or treatment covered by the health carrier that is
more beneficial than the recommended or requested health care service or
treatment described in subparagraph (d) of this paragraph;
d. The covered person's treating physician:
i. 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
ii. Who is a 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;
e. The covered person has exhausted the
health carrier's internal grievance process unless the covered person is not
required to exhaust the health carrier's internal grievance process pursuant to
Rule 15.06 of this Regulation; and
f. The covered person has provided all the
information and forms required by the Commissioner that are necessary to
process an external review, including the release form provided under Rule
15.04(B) of this Regulation.
C.
1.
Within one (1) business day after completion of the preliminary review, the
health carrier shall notify the Commissioner and the covered person and, if
applicable, the covered person's authorized representative in writing whether:
a. The request is complete; and
b. The request is eligible for external
review.
2. If the
request:
a. Is not complete, the health
carrier shall inform in writing the Commissioner and the covered person and, if
applicable, the covered person's authorized representative and include in the
notice what information or materials are needed to make the request complete;
or
b. Is not eligible for external
review, the health carrier shall inform the covered person, the covered
person's authorized representative, if applicable, and the Commissioner in
writing and include in the notice the reasons for its
ineligibility.
3.
a. The Commissioner may specify the form for
the health carrier's notice of initial determination under paragraph (2) and
any supporting information to be included in the notice.
b. The notice of initial determination
provided under paragraph (2) shall include a statement informing the covered
person and, if applicable, the covered person's authorized representative that
a health carrier's initial determination that the external review request is
ineligible for review may be appealed to the Commissioner.
4.
a. The
Commissioner may determine that a request is eligible for external review under
subsection B(2) notwithstanding a health carrier's initial determination that
the request is ineligible and require that it be referred for external review.
b. In making a determination under
subparagraph (a) of this paragraph, the Commissioner's decision shall be made
in accordance with the terms of the covered person's health benefit plan and
shall be subject to all applicable provisions of this Regulation.
5. Whenever a request for external
review is determined eligible for external review, the health carrier shall
notify the Commissioner and the covered person and, if applicable, the covered
person's authorized representative.
D.
1.
Within one (1) business day after the receipt of the notice from the health
carrier that the external review request is eligible for external review
pursuant to subsection A(2)(d) or subsection C(5), the Commissioner shall:
a. Assign an independent review organization
to conduct the external review from the list of approved independent review
organizations compiled and maintained by the Commissioner pursuant to Rule
15.11 of this Regulation and notify the health carrier of the name of the
assigned independent review organization; and
b. Notify in writing the covered person and,
if applicable, the covered person's authorized representative of the request's
eligibility and acceptance for external review.
2. The Commissioner shall include in the
notice provided to the covered person and, if applicable, the covered person's
authorized representative a statement that the covered person or the covered
person's authorized representative may submit in writing to the assigned
independent review organization within five (5) business days following the
date of receipt of the notice provided pursuant to paragraph (1) additional
information that the independent review organization shall consider when
conducting the external review. The independent review organization is not
required to, but may, accept and consider additional information submitted
after five (5) business days.
3.
Within one (1) business day after the receipt of the notice of assignment to
conduct the external review pursuant to paragraph (1), the assigned independent
review organization shall:
a. Select one or
more clinical reviewers, as it determines is appropriate, pursuant to paragraph
(4) to conduct the external review; and
b. Based on the opinion of the clinical
reviewer, or opinions if more than one clinical reviewer has been selected to
conduct the external review, make a decision to uphold or reverse the adverse
determination or final adverse determination.
4.
a. In
selecting clinical reviewers pursuant to paragraph (3)(a), the assigned
independent review organization shall select physicians or other health care
professionals who meet the minimum qualifications described in Rule 15.12 of
this Regulation and, through clinical experience in the past three (3) years,
are experts in the treatment of the covered person's condition and
knowledgeable about the recommended or requested health care service or
treatment.
b. Neither the covered
person, the covered person's authorized representative, if applicable, nor the
health carrier shall choose or control the choice of the physicians or other
health care professionals to be selected to conduct the external
review.
5. In accordance
with subsection H, each clinical reviewer shall provide a written opinion to
the assigned independent review organization on whether the recommended or
requested health care service or treatment should be covered.
6. In reaching an opinion, clinical reviewers
are not bound by any decisions or conclusions reached during the health
carrier's utilization review process or the health carrier's internal grievance
process.
E.
1. Within five (5) business days after the
date of receipt of the notice provided pursuant to subsection D(1), the health
carrier or its designee utilization review organization shall provide to the
assigned independent review organization, the documents and any information
considered in making the adverse determination or the final adverse
determination.
2. Except as
provided in paragraph (3), failure by the health carrier or its designee
utilization review organization to provide the documents and information within
the time specified in paragraph (1) shall not delay the conduct of the external
review.
3.
a. If the health carrier or its designee
utilization review organization has failed to provide the documents and
information within the time specified in paragraph (1), the assigned
independent review organization may terminate the external review and make a
decision to reverse the adverse determination or final adverse
determination.
b. Immediately upon
making the decision under subparagraph (a) of this paragraph, the independent
review organization shall notify the covered person, the covered person's
authorized representative, if applicable, the health carrier, and the
Commissioner.
F.
1. Each
clinical reviewer selected pursuant to subsection D shall review all of the
information and documents received pursuant to subsection E and any other
information submitted in writing by the covered person or the covered person's
authorized representative pursuant to subsection D(2).
2. Upon receipt of any information submitted
by the covered person or the covered person's authorized representative
pursuant to subsection D(2), within one (1) business day after the receipt of
the information, the assigned independent review organization shall forward the
information to the health carrier.
G.
1. Upon
receipt of the information required to be forwarded pursuant to subsection
F(2), the health carrier may reconsider its adverse determination or final
adverse determination that is the subject of the external review.
2. Reconsideration by the health carrier of
its adverse determination or final adverse determination pursuant to paragraph
(1) shall not delay or terminate the external review.
3. The external review may terminated only if
the health carrier 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.
4.
a. Immediately upon making the decision to
reverse its adverse determination or final adverse determination, as provided
in paragraph (3), the health carrier shall notify the covered person, the
covered person's authorized representative if applicable, the assigned
independent review organization, and the Commissioner in writing of its
decision.
b. The assigned
independent review organization shall terminate the external review upon
receipt of the notice from the health carrier sent pursuant to subparagraph (a)
of this paragraph.
H.
1.
Except as provided in paragraph (3), within twenty (20) days after being
selected in accordance with subsection D to conduct the external review, each
clinical reviewer shall provide an opinion to the assigned independent review
organization pursuant to subsection I on whether the recommended or requested
health care service or treatment should be covered.
2. Except for an opinion provided pursuant to
paragraph (3), each clinical reviewer's opinion shall be in writing and include
the following information:
a. A description
of the covered person's medical condition;
b. 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 services or treatments 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;
c. A description and analysis of any medical
or scientific evidence, as that term is defined in Rule 15.02(DD) of this
Regulation, considered in reaching the opinion;
d. A description and analysis of any
evidence-based standard, as that term is defined in Rule 15.02(S) of this
Regulation; and
e. Information on
whether the reviewer's rationale for the opinion is based on subsection I(5)(a)
or (b).
3.
a. For an expedited external review, each
clinical reviewer shall provide an opinion orally or in writing to the assigned
independent review organization as expeditiously as the covered person's
medical condition or circumstances requires, but in no event more than five (5)
calendar days after being selected in accordance with subsection D.
b. If the opinion provided pursuant to
subparagraph (a) of this paragraph was not in writing, within forty-eight (48)
hours following the date the opinion was provided, the clinical reviewer shall
provide written confirmation of the opinion to the assigned independent review
organization and include the information required under paragraph
(2).
I. In
addition to the documents and information provided pursuant to subsection A(2)
or subsection E, each clinical reviewer selected pursuant to subsection D, 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 H:
1. The covered
person's pertinent medical records;
2. The attending physician or health care
professional's recommendation;
3.
Consulting reports from appropriate health care professionals and other
documents submitted by the health carrier, covered person, the covered person's
authorized representative, or the covered person's treating physician or health
care professional;
4. The terms of
coverage under the covered person's health benefit plan with the health carrier
to ensure that, but for the health carrier's determination that the recommended
or requested health care service or treatment that is the 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 health carrier; and
5. Whether:
a. 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
b. 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 than 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.
J.
1.
a.
Except as provided in subparagraph (b) of this paragraph, within twenty (20)
days after the date it receives the opinion of each clinical reviewer pursuant
to subsection I, the assigned independent review organization, in accordance
with paragraph (2), shall make a decision and provide written notice of the
decision to:
i. The covered person;
ii. If applicable, the covered person's
authorized representative;
iii. The
health carrier; and
iv. The
Commissioner.
b.
i. For an expedited external review, within
forty-eight (48) hours after the date it receives the opinion of each clinical
reviewer pursuant to subsection I, the assigned independent review
organization, in accordance with paragraph (2), shall make a decision and
provide notice of the decision orally or in writing to the persons listed in
subparagraph (a) of this paragraph.
ii. If the notice provided under item (i) was
not in writing, within forty-eight (48) hours after the date of providing that
notice, the assigned independent review organization shall provide written
confirmation of the decision to the persons listed in subparagraph (a) of this
paragraph and include the information set forth in paragraph (3).
2.
a. If a majority of the clinical reviewers
recommend that the recommended or requested health care service or treatment
should be covered, the independent review organization shall make a decision to
reverse the health carrier's adverse determination or final adverse
determination.
b. If a majority of
the clinical reviewers recommend that the recommended or requested health care
service or treatment should not be covered, the independent review organization
shall make a decision to uphold the health carrier's adverse determination or
final adverse determination.
c.
i. If the clinical reviewers are evenly split
as to whether the recommended or requested health care service or treatment
should be covered, the independent review organization shall obtain the opinion
of an additional clinical reviewer in order for the independent review
organization to make a decision based on the opinions of a majority of the
clinical reviewers pursuant to subparagraph (a) or (b) of this
paragraph.
ii. The additional
clinical reviewer selected under item (i) shall use the same information to
reach an opinion as the clinical reviewers who have already submitted their
opinions pursuant to subsection I.
iii. The selection of the additional clinical
reviewer under this subparagraph shall not extend the time within which the
assigned independent review organization is required to make a decision based
on the opinions of the clinical reviewers selected under subsection D pursuant
to paragraph (1).
3. The independent review organization shall
include in the notice provided pursuant to paragraph (1):
a. A general description of the reason for
the request for external review;
b.
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;
c. The date the
independent review organization was assigned by the Commissioner to conduct the
external review;
d. The date the
external review was conducted;
e.
The date of its decision;
f. The
principal reason or reasons for its decision; and
g. The rationale for its
decision.
4. Upon receipt
of a notice of a decision pursuant to paragraph (1) reversing the adverse
determination or final adverse determination, the health carrier 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.
K. The
assignment by the Commissioner of an approved independent review organization
to conduct an external review in accordance with this section shall be done on
a random basis among those approved independent review organizations 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 Rule 15.12(D) of this Regulation.
Notes
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