‘‘(B) an advanced directive (as defined in
section 1866(f)(3)) or other end-of-life pref-
erence is involved.’’.
(c) STATE HEALTH INSURANCE OMBUDSMEN.—Part
C of title XVIII of the Public Health Service Act, as pre-
viously inserted and amended, is further amended by add-
ing at the end the following:
‘‘SEC. 2773. STATE HEALTH INSURANCE OMBUDSMEN.
‘‘(a) IN GENERAL.—Each State that obtains a grant
under subsection (c) shall establish and maintain a Health
Insurance Ombudsman. Such Ombudsman may be part of
a independent, nonprofit entity, and shall be responsible
for at least the following:
‘‘(1) To assist consumers in the State in choos-
ing among health insurance coverage.
‘‘(2) To provide counseling and assistance to
enrollees dissatisfied with their treatment by health
insurance issuers in regard to such coverage and in
the filing of complaints and appeals regarding deter-
minations under such coverage.
‘‘(3) To investigate instances of poor quality or
improper treatment of enrollees by health insurance
issuers in regard to such coverage and to bring such
instances to the attention of the applicable State au-
thority.
‘‘(b) FEDERAL ROLE.—In the case of any State that
does not establish and maintain such an Ombudsman
under subsection (a), the Secretary shall provide for the
establishment and maintenance of such an official as will
carry out with respect to that State the functions other-
wise provided under subsection (a) by a Health Insurance
Ombudsman.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to the Secretary such
amounts as may be necessary to provide for grants to
States to establish and operate Health Insurance Ombuds-
men under subsection (a) or for the operation of Ombuds-
men under subsection (b).’’.
SEC. 104. PATIENT CONFIDENTIALITY.
Part C of title XVIII of the Public Health Service
Act, as previously inserted and amended, is further
amended by adding at the end the following:
‘‘SEC. 2774. PROTECTION OF PATIENT CONFIDENTIALITY.
‘‘(a) IN GENERAL.—A health insurance issuer that
offers health insurance coverage shall establish appro-
priate written policies and procedures to ensure that all
applicable State and Federal laws to protect the confiden-
tiality of individually identifiable medical information are
followed.
‘‘(b) DETAILS.—Such policies and procedures shall
provide that individually identifiable medical information
should not be disclosed except under the following cir-
cumstances:
‘‘(1) For purposes necessary to perform re-
quired quality assurance functions, to meet require-
ments of purchasers and providers (in order to de-
termine entitlement to coverage and to administer
payments), and to conduct approved, bona fide clini-
cal or health services research. The disclosure of in-
formation in such circumstances should not contain
patient identifiers which could lead to violation of in-
dividual privacy and harm patients.
‘‘(2) Upon the express consent of the covered
person.
‘‘(3) Pursuant to law or court order for the pro-
duction of evidence or the discovery thereof or other
legally mandated disclosure.
‘‘(4) In the event of claim or litigation between
the covered person and the issuer.’’.
SEC. 105. COVERAGE UNDER APPROVED CLINICAL TRIALS.
Such part is further amended by adding at the end
the following new section:
‘‘SEC. 2775. COVERAGE FOR INDIVIDUALS PARTICIPATING
IN APPROVED CLINICAL TRIALS.
‘‘(a) IN GENERAL.—If a health insurance issuer of-
fers health insurance coverage to a qualified enrollee (as
defined in subsection (b)), the issuer—
‘‘(1) may not deny the enrollee participation in
the clinical trial referred to in subsection (b)(2);
‘‘(2) subject to subsection (c), may not deny (or
limit or impose additional conditions on) the cov-
erage of routine patient costs for items and services
furnished in connection with participation in the
trial; and
‘‘(3) may not discriminate against the enrollee
on the basis of the enrollee’s participation in such
trial.
‘‘(b) QUALIFIED ENROLLEE DEFINED.—For pur-
poses of subsection (a), the term ‘qualified enrollee’ means
an enrollee under health insurance coverage who meets the
following conditions:
‘‘(1) The enrollee has a life-threatening or seri-
ous illness for which no standard treatment is effec-
tive.
‘‘(2) The enrollee is eligible to participate in an
approved clinical trial with respect to treatment of
such illness.
‘‘(3) The enrollee and the referring physician
conclude that the enrollee’s participation in such
trial would be appropriate.
‘‘(4) The enrollee’s participation in the trial of-
fers potential for significant clinical benefit for the
enrollee.
‘‘(c) PAYMENT.—
‘‘(1) IN GENERAL.—Under this section an is-
suer shall provide for payment for routine patient
costs described in subsection (a)(2) but is not re-
quired to pay for costs of items and services that are
reasonably expected (as determined by the Sec-
retary) to be paid for by the sponsors of an ap-
proved clinical trial.
‘‘(2) PAYMENT RATE.—In the case of covered
items and services provided by—
‘‘(A) a participating provider, the payment
rate shall be at the agreed upon rate, or
‘‘(B) a nonparticipating provider, the pay-
ment rate shall be at the rate the issuer would
normally pay for comparable services under
subparagraph (A).
‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—In this
section, the term ‘approved clinical trial’ means a clinical
research study or clinical investigation approved and fund-
ed by one or more of the following:
‘‘(1) The National Institutes of Health.
‘‘(2) A cooperative group or center of the Na-
tional Institutes of Health.
‘‘(3) The Department of Veterans Affairs.
‘‘(4) The Department of Defense.’’.
SEC. 106. ACCESS TO NEEDED PRESCRIPTION DRUGS;
DRUG UTILIZATION PROGRAM.
Such part is further amended by adding at the end
the following new section:
‘‘SEC. 2776. ACCESS TO NEEDED PRESCRIPTION DRUGS;
DRUG UTILIZATION PROGRAM.
‘‘(a) ACCESS.—If a health insurance issuer offers
health insurance coverage (whether directly or through
any agent) that provides benefits with respect to prescrip-
tion drugs but the coverage limits such benefits to drugs
included in a formulary, the issuer shall—
‘‘(1) ensure participation of participating physi-
cians in the development of the formulary;
‘‘(2) disclose the nature of the formulary re-
strictions; and
‘‘(3) provide for exceptions from the formulary
limitation when medical necessity, as determined by
the enrollee’s physician subject to reasonable review