1370.4
. (a) Every health care service plan shall provide an
external, independent review process to examine the plan's coverage
decisions regarding experimental or investigational therapies for
individual enrollees who meet all of the following criteria:
(1) (A) The enrollee has a life-threatening or seriously
debilitating condition.
(B) For purposes of this section, "life-threatening" means either
or both of the following:
(i) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(ii) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(C) For purposes of this section, "seriously debilitating" means
diseases or conditions that cause major irreversible morbidity.
(2) The enrollee's physician certifies that the enrollee has a
condition, as defined in paragraph (1), for which standard therapies
have not been effective in improving the condition of the enrollee,
for which standard therapies would not be medically appropriate for
the enrollee, or for which there is no more beneficial standard
therapy covered by the plan than the therapy proposed pursuant to
paragraph (3).
(3) Either (A) the enrollee's physician, who is under contract
with or employed by the plan, has recommended a drug, device,
procedure, or other therapy that the physician certifies in writing
is likely to be more beneficial to the enrollee than any available
standard therapies, or (B) the enrollee, or the enrollee's physician
who is a licensed, board-certified or board-eligible physician
qualified to practice in the area of practice appropriate to treat
the enrollee's condition, has requested a therapy that, based on two
documents from the medical and scientific evidence, as defined in
subdivision (d), is likely to be more beneficial for the enrollee
than any available standard therapy. The physician certification
pursuant to this subdivision shall include a statement of the
evidence relied upon by the physician in certifying his or her
recommendation. Nothing in this subdivision shall be construed to
require the plan to pay for the services of a nonparticipating
physician provided pursuant to this subdivision, that are not
otherwise covered pursuant to the plan contact.
(4) The enrollee has been denied coverage by the plan for a drug,
device, procedure, or other therapy recommended or requested pursuant
to paragraph (3).
(5) The specific drug, device, procedure, or other therapy
recommended pursuant to paragraph (3) would be a covered service,
except for the plan's determination that the therapy is experimental
or investigational.
(b) The plan's decision to delay, deny, or modify experimental or
investigational therapies shall be subject to the independent medical
review process under Article 5.55 (commencing with Section 1374.30)
except that, in lieu of the information specified in subdivision (b)
of Section 1374.33, an independent medical reviewer shall base his or
her determination on relevant medical and scientific evidence,
including, but not limited to, the medical and scientific evidence
defined in subdivision (d).
(c) The independent medical review process shall also meet the
following criteria:
(1) The plan shall notify eligible enrollees in writing of the
opportunity to request the external independent review within five
business days of the decision to deny coverage.
(2) If the enrollee's physician determines that the proposed
therapy would be significantly less effective if not promptly
initiated, the analyses and recommendations of the experts on the
panel shall be rendered within seven days of the request for
expedited review. At the request of the expert, the deadline shall be
extended by up to three days for a delay in providing the documents
required. The timeframes specified in this paragraph shall be in
addition to any otherwise applicable timeframes contained in
subdivision (c) of Section 1374.33.
(3) Each expert's analysis and recommendation shall be in written
form and state the reasons the requested therapy is or is not likely
to be more beneficial for the enrollee than any available standard
therapy, and the reasons that the expert recommends that the therapy
should or should not be provided by the plan, citing the enrollee's
specific medical condition, the relevant documents provided, and the
relevant medical and scientific evidence, including, but not limited
to, the medical and scientific evidence as defined in subdivision
(d), to support the expert's recommendation.
(4) Coverage for the services required under this section shall be
provided subject to the terms and conditions generally applicable to
other benefits under the plan contract.
(d) For the purposes of subdivision (b), "medical and scientific
evidence" means the following sources:
(1) 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.
(2) Peer-reviewed literature, biomedical compendia, and other
medical literature that meet the criteria of the National Institutes
of Health's National Library of Medicine for indexing in Index
Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS database of
Health Services Technology Assessment Research (HSTAR).
(3) Medical journals recognized by the Secretary of Health and
Human Services, under Section 1861(t)(2) of the Social Security Act.
(4) Either of the following reference compendia:
(A) The American Hospital Formulary Service's Drug Information.
(B) The American Dental Association Accepted Dental Therapeutics.
(5) Any of the following reference compendia, if recognized by the
federal Centers for Medicare and Medicaid Services as part of an
anticancer chemotherapeutic regimen:
(A) The Elsevier Gold Standard's Clinical Pharmacology.
(B) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(C) The Thomson Micromedex DrugDex.
(6) Findings, studies, or research conducted by or under the
auspices of federal government agencies and nationally recognized
federal research institutes, including the Federal Agency for Health
Care Policy and Research, National Institutes of Health, National
Cancer Institute, National Academy of Sciences, Health Care Financing
Administration, 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.
(7) Peer-reviewed abstracts accepted for presentation at major
medical association meetings.
(e) The independent review process established by this section
shall be required on and after January 1, 2001.