                                 CODE OF VIRGINIA

EXTERNAL REVIEW OF EXPERIMENTAL OR INVESTIGATIONAL TREATMENT ADVERSE
DETERMINATIONS (§ 38.2-3563)

A. Within 120 days after the date of receipt of a notice of the right to an
external review 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 or his authorized representative may file a
request for external review with the Commission.

B. A covered person or his authorized representative may make an oral request
for an expedited external review of the adverse determination or final adverse
determination if the covered person&#8217;s treating physician certifies, in
writing, that the recommended or requested health care service or treatment
would be significantly less effective if not promptly initiated. The following
shall apply with regard to such requests for an expedited external review:

   1. Upon receipt of a request for an expedited external review, the Commission
   shall promptly notify the health carrier;

   2. Upon notice of the request for expedited external review, the health
   carrier shall promptly determine whether the request meets the eligibility
   requirements in subsection D. The health carrier shall promptly notify the
   Commission and the covered person and his authorized representative, if any,
   of its eligibility determination. Such notice shall include a statement
   informing the covered person and his authorized representative, if any, that a
   health carrier&#8217;s ineligibility determination may be appealed to the
   Commission;

   3. If the health carrier makes an ineligibility determination, the Commission
   may determine that a request is eligible for external review and require that
   it be referred for external review. The Commission shall make such
   determination in accordance with the terms of the covered person&#8217;s
   health benefit plan and the requirements of subsection D;

   4. Upon receipt of the notice that the expedited external review request meets
   the eligibility requirements, the Commission shall promptly assign an
   independent review organization to review the expedited request and notify the
   health carrier of the name of the assigned independent review organization;

   5. Promptly upon receipt of the notice of the assigned independent review
   organization, the health carrier or its designee utilization review entity
   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, by telephone,
   facsimile, or any other available expeditious method;

   6. Upon receipt of the notice from the Commission, the assigned independent
   review organization shall promptly assign one or more clinical reviewers in
   accordance with the provisions of subdivision F 3 to conduct the external
   review;

   7. In reaching an opinion, each clinical reviewer shall also consider the
   documents listed in subsection J. Each clinical reviewer shall provide an
   opinion orally or in writing to the assigned independent review organization
   as expeditiously as the covered person&#8217;s medical condition or
   circumstances require, but in no event more than five calendar days after
   being selected. If the opinion provided was not in writing, within 48 hours
   following the date of the opinion the clinical reviewer shall provide a
   written opinion to the assigned independent review organization. The written
   opinion shall include the information described in subsection K.
   Recommendations from more than one clinical reviewer shall meet the provisions
   of subsection L; and

   8. Within 48 hours after the date it receives an opinion from all clinical
   reviewers, the assigned independent review organization shall make a decision
   and provide notice of the decision orally or in writing to the covered person,
   his authorized representative, if any, the health carrier, and the Commission.
   If the notice was not in writing, within 48 hours after the date of the
   notice, the assigned independent review organization shall provide written
   confirmation of the decision to the covered person, his authorized
   representative, if any, the health carrier, and the Commission. The decision
   shall include the information described in subsection M.

C. Within one business day after the date of receipt of the request for a
standard external review, the Commission shall notify the health carrier.

D. Within five business days following the date of receipt of such notice, the
health carrier shall conduct and complete a preliminary review of the request to
determine whether:

   1. 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;

   2. The recommended or requested health care service or treatment is a covered
   service except for the health carrier&#8217;s determination that the service
   or treatment is experimental or investigational for the particular medical
   condition and is not explicitly listed as an excluded benefit under the
   covered person&#8217;s health benefit plan;

   3. The covered person&#8217;s treating physician has certified that one of the
   following situations is applicable:
   				a. Standard health care services or treatments have not been effective in
   improving the condition of the covered person;
   				b. Standard health care services or treatments are not medically
   appropriate for the covered person; or
   				c. There is no available standard health care service or treatment covered
   that is more beneficial than the recommended or requested health care service
   or treatment;

   4. The covered person&#8217;s treating physician:
   				a. 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&#8217;s opinion, than any available standard health care
   services or treatments; or
   				b. Who is a licensed, board certified, or board eligible physician
   qualified to practice in the area of medicine appropriate to treat the covered
   person&#8217;s condition, has certified in writing that scientifically valid
   studies using accepted protocols demonstrate that the health care service or
   treatment requested is likely to be more beneficial to the covered person than
   any available standard health care services or treatments;

   5. The covered person has exhausted or is deemed to have exhausted the health
   carrier&#8217;s internal appeal process; and

   6. The covered person has provided all the required information and forms that
   are necessary to process an external review.

E. Within one business day after completion of the preliminary review, the
health carrier shall notify in writing the Commission and the covered person and
his authorized representative, if any, whether the request is complete and
eligible for external review. The following shall apply with regard to such
requests:

   1. If the request is not complete, the health carrier shall inform in writing
   the Commission, the covered person, and his authorized representative, if any,
   and include in the notice what information or materials are needed to make the
   request complete. If the request is not eligible for external review, the
   health carrier shall inform the covered person, his authorized representative,
   if any, and the Commission in writing and include in the notice the reasons
   for its ineligibility. Such notice shall include a statement informing the
   covered person and his authorized representative, if any, that the health
   carrier&#8217;s determination of ineligibility may be appealed to the
   Commission; and

   2. If the health carrier makes an ineligibility determination, the Commission
   may determine that a request is eligible for external review and require that
   it be referred for external review. In making this determination, the
   Commission&#8217;s decision shall be made in accordance with the terms of the
   covered person&#8217;s health benefit plan and the requirements of subsection
   D.

F. Within one business day after the receipt of the notice from the health
carrier, the Commission shall assign an independent review organization to
conduct the external review and notify in writing the health carrier, the
covered person, and his authorized representative, if any, of the
request&#8217;s eligibility and acceptance for external review, and the name of
the assigned independent review organization. The following shall apply with
regard to such an external review:

   1. The Commission shall include in such notice a statement that the covered
   person or his authorized representative, if any, may submit in writing to the
   assigned independent review organization, within five business days following
   the date of receipt, additional information that the independent review
   organization shall consider when conducting the external review;

   2. Within one business day after the receipt of such notice, the assigned
   independent review organization shall select one or more clinical reviewers,
   as it determines is appropriate, to conduct the external review; and

   3. In selecting clinical reviewers, the assigned independent review
   organization shall select physicians or other health care professionals who
   meet the minimum qualifications of &#xA7; 38.2-3565 and, through clinical
   experience in the past three years, are experts in the treatment of the
   covered person&#8217;s condition and knowledgeable about the recommended or
   requested health care service or treatment. Neither the covered person, his
   authorized representative, if any, 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.

G. Within five business days after the date of receipt of the notice from the
Commission, the health carrier or its designee utilization review entity shall
provide to the assigned independent review organization the documents and any
information considered in making the adverse determination or the final adverse
determination. Failure by the health carrier or its designee utilization review
entity to provide the documents and information within the required time
specified shall not delay the conduct of the external review. If the health
carrier or its designee utilization review entity has failed to provide the
documents and information within the required time specified, the assigned
independent review entity may terminate the external review and make a decision
to reverse the adverse determination or final adverse determination. Promptly
upon making such decision, the independent review organization shall notify the
covered person, his authorized representative, if any, the health carrier, and
the Commission.

H. Each clinical reviewer selected shall review all of the information and
documents timely received from the health carrier and any other information
submitted in writing by the covered person or his authorized representative. The
assigned independent review organization is not required to, but may, accept and
consider information submitted late from the covered person or his authorized
representative, if any. Upon receipt of any information submitted by the covered
person or his authorized representative, within one business day after the
receipt of the information, the assigned independent review organization shall
forward the information to the health carrier.

I. Upon receipt of the information from the assigned independent review
organization, the health carrier may reconsider its adverse determination or
final adverse determination. Reconsideration by the health carrier of its
adverse determination or final adverse determination shall not delay or
terminate the external review. The external review may be terminated only if the
health carrier decides to reverse its adverse determination or final adverse
determination and provide coverage or payment for the recommended or requested
health care service or treatment. Promptly upon making the decision to reverse
its adverse determination or final adverse determination, the health carrier
shall notify the covered person, his authorized representative, if any, the
assigned independent review organization, and the Commission in writing of its
decision. Upon receipt of notice of the health carrier&#8217;s decision to
reverse its adverse determination or final adverse determination, the assigned
independent review organization shall terminate the external review.

J. To the extent the information or documents are available and the reviewer
considers appropriate, each clinical reviewer shall also consider the following
in reaching an opinion:

   1. The covered person&#8217;s pertinent medical records;

   2. The attending physician&#8217;s or health care professional&#8217;s
   recommendation;

   3. Consulting reports from appropriate health care professionals and other
   documents submitted by the health carrier, covered person, his authorized
   representative, or the covered person&#8217;s treating physician or health
   care professional;

   4. Whether the recommended or requested health care service or treatment is a
   covered service except for the health carrier&#8217;s determination that the
   service or treatment is experimental or investigational; and

   5. Whether 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 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.

K. Within 20 days after being selected to conduct a standard external review,
each clinical reviewer shall provide an opinion to the assigned independent
review organization on whether the recommended or requested health care service
or treatment should be covered. Each clinical reviewer&#8217;s opinion shall be
in writing and include the following information: a description of the covered
person&#8217;s medical condition; 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 more 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; a
description and analysis of any medical or scientific evidence considered in
reaching the opinion; a description and analysis of any evidence-based standard;
and information on the extent, if any, to which the reviewer&#8217;s rationale
for the opinion regarding the recommended or requested health care service or
treatment is based on (i) whether the health care service or treatment has been
approved by the federal Food and Drug Administration for the condition or (ii)
medical or scientific evidence or evidence-based standards that demonstrate the
recommended or requested health care service or treatment is more likely than
not to be more 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.

L. Within 20 days after the date it receives an opinion from all clinical
reviewers, the assigned independent review organization shall make a decision
and provide written notice to the covered person, his authorized representative,
if any, the health carrier, and the Commission. If:

   1. 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&#8217;s adverse determination or final adverse determination;

   2. 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&#8217;s adverse determination or final adverse determination; or

   3. 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. The additional clinical reviewer selected shall use the same
   information as the original clinical reviewers. The selection of the
   additional clinical reviewer shall not extend the time within which the
   assigned independent review organization is required to make a decision.

M. The independent review organization shall include in the notice required
pursuant to subsection L a general description of the reason for the request for
external review; 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&#8217;s recommendation; the date the independent review
organization was assigned by the Commission to conduct the external review; the
date the external review was conducted; the date of its decision; the principal
reason or reasons for its decision; and the rationale for its decision.

N. Upon receipt of a notice of a decision reversing the adverse determination or
final adverse determination, the health carrier shall promptly approve coverage
of the recommended or requested health care service or treatment.

HISTORY: 2011, c. 788.