102 
section 505 of the Federal Food, Drug, 
and Cosmetic Act, without regard to any 
postmarketing 
requirements 
that 
may 
apply under such Act; or 
(ii) is included in the labeling author-
ized by the application in effect for the 
drug under section 351 of the Public 
Health Service Act, without regard to any 
postmarketing 
requirements 
that 
may 
apply pursuant to such section; or 
(B) in the case of a medical device, is in-
cluded in the labeling authorized by a regula-
tion under subsection (d) or (e) of section 513 
of the Federal Food, Drug, and Cosmetic Act, 
an order under subsection (f) of such section, or 
an application approved under section 515 of 
such Act, without regard to any postmarketing 
requirements that may apply under such Act. 
(2) CONSTRUCTION.—Nothing in this sub-
section shall be construed as requiring a group 
health plan (or health insurance coverage offered in 
connection with such a plan) to provide any coverage 
of prescription drugs or medical devices.
103 
SEC. 119. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
APPROVED CLINICAL TRIALS. 
(a) COVERAGE.— 
(1) IN GENERAL.—If a group health plan, or 
health insurance issuer that is providing health in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or 
issuer— 
(A) may not deny the individual participa-
tion in the clinical trial referred to in subsection 
(b)(2); 
(B) subject to subsection (c), may not deny 
(or limit or impose additional conditions on) the 
coverage of routine patient costs for items and 
services furnished in connection with participa-
tion in the trial; and 
(C) may not discriminate against the indi-
vidual on the basis of the enrollee’s participa-
tion in such trial. 
(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses of paragraph (1)(B), routine patient costs do 
not include the cost of the tests or measurements 
conducted primarily for the purpose of the clinical 
trial involved. 
(3) USE OF IN-NETWORK PROVIDERS.—If one 
or more participating providers is participating in a
104 
clinical trial, nothing in paragraph (1) shall be con-
strued as preventing a plan or issuer from requiring 
that a qualified individual participate in the trial 
through such a participating provider if the provider 
will accept the individual as a participant in the 
trial. 
(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses of subsection (a), the term ‘‘qualified individual’’ 
means an individual who is a participant or beneficiary 
in a group health plan, or who is an enrollee under health 
insurance coverage, and who meets the following condi-
tions: 
(1)(A) The individual has a life-threatening or 
serious illness for which no standard treatment is ef-
fective. 
(B) The individual is eligible to participate in 
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness. 
(C) The individual’s participation in the trial 
offers meaningful potential for significant clinical 
benefit for the individual. 
(2) Either— 
(A) the referring physician is a partici-
pating health care professional and has con-
cluded that the individual’s participation in
105 
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1); or 
(B) the participant, beneficiary, or enrollee 
provides medical and scientific information es-
tablishing that the individual’s participation in 
such trial would be appropriate based upon the 
individual meeting the conditions described in 
paragraph (1). 
(c) PAYMENT.— 
(1) IN GENERAL.—Under this section a group 
health plan and a health insurance issuer shall pro-
vide for payment for routine patient costs described 
in subsection (a)(2) but is not required to pay for 
costs of items and services that are reasonably ex-
pected (as determined by the appropriate Secretary) 
to be paid for by the sponsors of an approved clin-
ical 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 plan or issuer
106 
would normally pay for comparable services 
under subparagraph (A). 
(d) APPROVED CLINICAL TRIAL DEFINED.— 
(1) IN
GENERAL.—In this section, the term 
‘‘approved clinical trial’’ means a clinical research 
study or clinical investigation— 
(A) approved and funded (which may in-
clude funding through in-kind contributions) by 
one or more of the following: 
(i) the National Institutes of Health; 
(ii) a cooperative group or center of 
the National Institutes of Health, includ-
ing a qualified nongovernmental research 
entity to which the National Cancer Insti-
tute has awarded a center support grant; 
(iii) either of the following if the con-
ditions described in paragraph (2) are 
met— 
(I) the Department of Veterans 
Affairs; 
(II) the Department of Defense; 
or 
(B) approved by the Food and Drug Ad-
ministration.
107 
(2) CONDITIONS
FOR
DEPARTMENTS.—The 
conditions described in this paragraph, for a study 
or investigation conducted by a Department, are 
that the study or investigation has been reviewed 
and approved through a system of peer review that 
the appropriate Secretary determines— 
(A) to be comparable to the system of peer 
review of studies and investigations used by the 
National Institutes of Health; and 
(B) assures unbiased review of the highest 
ethical standards by qualified individuals who 
have no interest in the outcome of the review. 
(e) CONSTRUCTION.—Nothing in this section shall be 
construed to limit a plan’s or issuer’s coverage with re-
spect to clinical trials. 
SEC. 120. REQUIRED COVERAGE FOR MINIMUM HOSPITAL 
STAY FOR MASTECTOMIES AND LYMPH NODE 
DISSECTIONS 
FOR 
THE 
TREATMENT 
OF 
BREAST CANCER AND COVERAGE FOR SEC-
ONDARY CONSULTATIONS. 
(a) INPATIENT CARE.— 
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer providing health insurance 
coverage, that provides medical and surgical benefits 
shall ensure that inpatient coverage with respect to
108 
the treatment of breast cancer is provided for a pe-
riod of time as is determined by the attending physi-
cian, in consultation with the patient, to be medi-
cally necessary and appropriate following— 
(A) a mastectomy; 
(B) a lumpectomy; or 
(C) a lymph node dissection for the treat-
ment of breast cancer. 
(2) EXCEPTION.—Nothing in this section shall 
be construed as requiring the provision of inpatient 
coverage if the attending physician and patient de-
termine that a shorter period of hospital stay is 
medically appropriate. 
(b) PROHIBITION ON CERTAIN MODIFICATIONS.—In 
implementing the requirements of this section, a group 
health plan, and a health insurance issuer providing health 
insurance coverage, may not modify the terms and condi-
tions of coverage based on the determination by a partici-
pant, beneficiary, or enrollee to request less than the min-
imum coverage required under subsection (a). 
(c) SECONDARY CONSULTATIONS.— 
(1) IN GENERAL.—A group health plan, and a 
health insurance issuer providing health insurance 
coverage, that provides coverage with respect to 
medical and surgical services provided in relation to
109 
the diagnosis and treatment of cancer shall ensure 
that full coverage is provided for secondary consulta-
tions by specialists in the appropriate medical fields 
(including pathology, radiology, and oncology) to 
confirm or refute such diagnosis. Such plan or issuer 
shall ensure that full coverage is provided for such 
secondary consultation whether such consultation is 
based on a positive or negative initial diagnosis. In 
any case in which the attending physician certifies in 
writing that services necessary for such a secondary 
consultation are not sufficiently available from spe-
cialists operating under the plan or coverage with re-
spect to whose services coverage is otherwise pro-
vided under such plan or by such issuer, such plan 
or issuer shall ensure that coverage is provided with 
respect to the services necessary for the secondary 
consultation with any other specialist selected by the 
attending physician for such purpose at no addi-
tional cost to the individual beyond that which the 
individual would have paid if the specialist was par-
ticipating in the network of the plan or issuer. 
(2) EXCEPTION.—Nothing in paragraph (1) 
shall be construed as requiring the provision of sec-
ondary consultations where the patient determines 
not to seek such a consultation.
110 
(d) PROHIBITION ON PENALTIES OR INCENTIVES.— 
A group health plan, and a health insurance issuer pro-
viding health insurance coverage, may not— 
(1) penalize or otherwise reduce or limit the re-
imbursement of a provider or specialist because the 
provider or specialist provided care to a participant, 
beneficiary, or enrollee in accordance with this sec-
tion; 
(2) provide financial or other incentives to a 
physician or specialist to induce the physician or 
specialist to keep the length of inpatient stays of pa-
tients following a mastectomy, lumpectomy, or a 
lymph node dissection for the treatment of breast 
cancer below certain limits or to limit referrals for 
secondary consultations; or 
(3) provide financial or other incentives to a 
physician or specialist to induce the physician or 
specialist to refrain from referring a participant, 
beneficiary, or enrollee for a secondary consultation 
that would otherwise be covered by the plan or cov-
erage involved under subsection (c). 
Subtitle C—Access to Information 
SEC. 121. PATIENT ACCESS TO INFORMATION. 
(a) REQUIREMENT.— 
(1) DISCLOSURE.—
111 
(A) IN GENERAL.—A group health plan, 
and a health insurance issuer that provides cov-
erage in connection with health insurance cov-
erage, shall provide for the disclosure to partici-
pants, beneficiaries, and enrollees— 
(i) of the information described in 
subsection (b) at the time of the initial en-
rollment of the participant, beneficiary, or 
enrollee under the plan or coverage; 
(ii) of such information on an annual 
basis— 
(I) in conjunction with the elec-
tion period of the plan or coverage if 
the plan or coverage has such an elec-
tion period; or 
(II) in the case of a plan or cov-
erage that does not have an election 
period, in conjunction with the begin-
ning of the plan or coverage year; and 
(iii) of information relating to any 
material reduction to the benefits or infor-
mation described in such subsection or 
subsection (c), in the form of a notice pro-
vided not later than 30 days before the 
date on which the reduction takes effect.
112 
(B) PARTICIPANTS, BENEFICIARIES, AND 
ENROLLEES.—The disclosure required under 
subparagraph (A) shall be provided— 
(i) jointly to each participant, bene-
ficiary, and enrollee who reside at the same 
address; or 
(ii) in the case of a beneficiary or en-
rollee who does not reside at the same ad-
dress as the participant or another en-
rollee, separately to the participant or 
other enrollees and such beneficiary or en-
rollee. 
(2) PROVISION OF INFORMATION.—Information 
shall be provided to participants, beneficiaries, and 
enrollees under this section at the last known ad-
dress maintained by the plan or issuer with respect 
to such participants, beneficiaries, or enrollees, to 
the extent that such information is provided to par-
ticipants, beneficiaries, or enrollees via the United 
States Postal Service or other private delivery serv-
ice. 
(b) REQUIRED INFORMATION.—The informational 
materials to be distributed under this section shall include 
for each option available under the group health plan or 
health insurance coverage the following: