fering managed care group health insurance) shall
provide—
‘‘(A) continuity of care and appropriate re-
ferral to specialists within the plan or coverage,
when specialty care is warranted,
‘‘(B) enrollees with access to medical spe-
cialists on a timely basis, and
‘‘(C) enrollees with a choice of specialists
when a referral is made.
‘‘(5) REQUIREMENT FOR POINT OF SERVICE OP-
TION.—A managed care group health plan (and a
health insurance issuer offering managed care group
health insurance) shall offer each enrollee with an
enrollment option under which the enrollee may re-
ceive benefits for services provided by nonparticipat-
ing health care professional or provider. The plan or
issuer may require that the enrollee pay a reasonable
premium to reflect the cost of such option.
‘‘(6) CONSULTATION FOR SECOND OPINIONS.—
A managed care group health plan (and a health in-
surance issuer offering managed care group health
insurance) shall provide enrollees with access to a
consultation for a second option.
‘‘(c) PROHIBITION OF GAG RULES.—A managed care
group health plan (and a health insurance issuer offering
managed care group health insurance)—
‘‘(1) shall not have any contract provision with
a health care professional that limits the health care
professional’s disclosure to an enrollee or on behalf
of an enrollee of any information relating to the en-
rollee’s medical condition or treatment options; and
‘‘(2) shall not penalize (through contract termi-
nation or otherwise) a health care professional—
‘‘(A) because the professional offers refer-
rals, or discusses any or all medically necessary
or appropriate care or treatment options (in-
cluding disclosing any information, determined
by the health care professional to be in the best
interest of the enrollee) with, or on behalf of,
an enrollee; or
‘‘(B) for discussing financial incentives and
financial arrangements between the health care
professional and the plan or issuer.
‘‘(d) COVERAGE OF DRUGS AND DEVICES.—
‘‘(1) IN
GENERAL.—A managed care group
health plan (and a health insurance issuer offering
managed care group health insurance) that provides
benefits with respect to drugs and medical devices
shall provide coverage for all drugs and medical de-
vices approved by the Food and Drug Administra-
tion, whether or not that drug or device has been
approved for the specific treatment or condition, so
long as the primary care practitioner or other medi-
cal specialist treating the enrollee determines the
drug or device is medically necessary and appro-
priate for the enrollee’s condition.
‘‘(2) OPERATION
OF
DRUG
UTILIZATION
RE-
VIEW PROGRAM.—A managed care group health plan
(and a health insurance issuer offering managed
care group health insurance) that provides benefits
with respect to prescription drugs shall establish and
operate a drug utilization review program that in-
cludes the following:
‘‘(A) Retrospective review of prescription
drugs furnished to enrollees.
‘‘(B) Education of physicians, enrollees,
and pharmacists regarding the appropriate use
of prescription drugs.
‘‘(C) An ongoing periodic examination of
data on outpatient prescription drugs to ensure
quality therapeutic outcomes for enrollees.
‘‘(D) A primary emphasis on enhancing
quality of care for enrollees by assuring appro-
priate drug therapy.
‘‘(E) Clinically relevant criteria and stand-
ards for drug therapy.
‘‘(F) Application of nonproprietary criteria
and standards, developed and revised through
an open, professional consensus process.
‘‘(G) Interventions which focus on improv-
ing therapeutic outcomes.
‘‘(H) An educational outreach program
that—
‘‘(i) is directed to enrollees, phar-
macists, and other health care profes-
sionals, and
‘‘(ii) emphasizes the appropriate use
of prescription drugs.
‘‘(I) Denial of services under prospective
review of drug therapy only in cases of enrollee
ineligibility, coverage limitations, or fraud.
‘‘(J) Determination of the appropriate
drug therapy for the enrollee by the prescribing
health care professional and prohibitions of sub-
stitutions without the direct approval of such
professional.
‘‘(e) COVERAGE OF EXPERIMENTAL TREATMENTS.—
‘‘(1) IN
GENERAL.—A managed care group
health plan (and a health insurance issuer offering
managed care group health insurance) that limits
coverage for services shall define the limitation and
disclose the limits in any agreement or certificate of
coverage. Such disclosure shall include—
‘‘(A) who is authorized to make such a de-
termination, and
‘‘(B) the criteria the plan or issuer uses to
determine whether a service is experimental.
‘‘(2) DENIALS.—A managed care group health
plan (and a health insurance issuer offering man-
aged care group health insurance) that denies cov-
erage for an experimental treatment, procedure,
drug, or device, for an enrollee who has a terminal
condition or illness shall provide the enrollee with a
denial letter within 20 working days of the submit-
ted request. The letter shall include—
‘‘(A) the name and title of the individual
making the decision;
‘‘(B) a statement setting forth the specific
medical and scientific reasons for denying cov-
erage;
‘‘(C) a description of alternative treatment,
services, or supplies covered by the plan or
under the coverage, if any; and
‘‘(D) a copy of the plan’s or issuer’s griev-
ance and appeal procedure.
‘‘(3) EXPERIMENTAL TREATMENT DEFINED.—
In this subsection, the term ‘experimental treatment’
means treatment that, while not commonly used for
a particular condition or illness, nevertheless is rec-
ognized for treatment of the particular condition or
illness, and there is no clearly superior, nonexperi-
mental treatment alternative available to the en-
rollee.
‘‘(f) QUALITY ASSURANCE PROGRAM.—
‘‘(1) IN
GENERAL.—A managed care group
health plan (and a health insurance issuer offering
managed care group health insurance) shall develop
comprehensive quality assurance standards, ade-
quate to identify, evaluate, and remedy problems re-
lating to access, continuity, and quality of care. The
standards shall include—
‘‘(A) an ongoing, written, internal quality
assurance program;