Authority and purpose.
(a) Some insurers deny payment for drugs that
have been approved by the Federal Food and Drug Administration (FDA) when the
drugs are used for indications other than those stated in the labelling
approved by the FDA (off-label use) while other insurers with similar coverage
terms pay for off-label use. Denial of payment for off-label use can interrupt
or effectively deny access to necessary and appropriate treatment for a person
being treated for a life-threatening illness.
(b) Equity among insured residents of this
state and fair claims settlement practices and fair competition among companies
providing coverage to residents of this state require comparable reimbursement
for prescribed drugs among insurers, health care service contractors, and
health maintenance organizations.
(c) Use of off-label indications often
provides efficacious drugs at a lower cost.
(d) To prevent unfair methods of claims
settlements, unfair competition, and unfair or deceptive acts or practices of
insurers and prohibited acts or practices of health care service contractors or
health maintenance organizations, this rule is adopted.
This regulation affects all insurance and health benefit
policies and contracts providing coverage for drugs to a resident of this state
which are issued, amended, delivered or renewed on or after January 1,
following definitions are used in this section:
(a) "Drug" or "drugs" means any substance
prescribed by a physician taken by mouth, injected into a muscle, the skin, a
blood vessel, or a cavity of the body, or applied to the skin to treat or
prevent a disease, and specifically includes drugs or biologicals used in an
anticancer chemotherapeutic regimen for a medically accepted indication or for
the treatment of people with HIV or AIDS.
(b) "Off-label" means the prescribed use of a
drug which is other than that stated in its FDA approved labelling.
(c) "Peer-reviewed medical literature" means
scientific studies printed in journals or other publications in which original
manuscripts are published only after having been critically reviewed for
scientific accuracy, validity, and reliability by unbiased independent experts.
Peer-reviewed medical literature does not include in-house publications of
pharmaceutical manufacturing companies.
(d) "Physician" means a medical doctor or
other health care provider acting within the scope of his or her professional
(e) "Policy" or "contract"
means any individual, group or blanket policy of insurance or health benefit
contract issued by a disability insurer, health care service contractor, or
health maintenance organization which is issued, amended, delivered or renewed
on or after January 1, 1995, and which provides coverage for drugs to a
resident of this state.
"Standard reference compendia" means:
American Hospital Formulary Service-Drug Information;
(ii) The American Medical Association Drug
(iii) The United States
Pharmacopoeia-Drug Information; or
(iv) Other authoritative compendia as
identified from time to time by the Federal Secretary of Health and Human
Services or the insurance commissioner.
Standards of coverage.
No insurance policy
or contract which
provides coverage for prescription drugs to a resident of this state shall
exclude coverage of any such drug for a particular indication on the grounds
that the drug has not been approved by the Federal Food and Drug Administration
for that indication, if such drug is recognized as effective for treatment of
(i) In one of the standard
(ii) In the
majority of relevant peer-reviewed medical literature if not recognized in one
of the standard reference compendia; or
(iii) By the Federal Secretary of Health and
Coverage of a prescription drug required by this section shall also include
medically necessary services associated with the administration of the
(c) This regulation shall not
be construed to require coverage for any drug when the Federal Food and Drug
Administration has determined its use to be contra-indicated.
(d) This regulation shall not be construed to
require coverage for experimental drugs not otherwise approved for any
indication by the Federal Food and Drug Administration.