116 
tations on choice of health care professionals re-
ferred to in section 112(b)(2) and the right to timely 
access to specialists care under section 114 if such 
section applies. 
(10) CLINICAL TRIALS.—A description of the 
circumstances and conditions under which participa-
tion in clinical trials is covered under the terms and 
conditions of the plan or coverage, and the right to 
obtain coverage for approved clinical trials under 
section 119 if such section applies. 
(11) PRESCRIPTION DRUGS.—To the extent the 
plan or issuer provides coverage for prescription 
drugs, a statement of whether such coverage is lim-
ited to drugs included in a formulary, a description 
of any provisions and cost-sharing required for ob-
taining on- and off-formulary medications, and a de-
scription of the rights of participants, beneficiaries, 
and enrollees in obtaining access to access to pre-
scription drugs under section 118 if such section ap-
plies. 
(12) EMERGENCY
SERVICES.—A summary of 
the rules and procedures for accessing emergency 
services, including the right of a participant, bene-
ficiary, or enrollee to obtain emergency services 
under the prudent layperson standard under section
117 
113, if such section applies, and any educational in-
formation that the plan or issuer may provide re-
garding the appropriate use of emergency services. 
(13) CLAIMS AND APPEALS.—A description of 
the plan or issuer’s rules and procedures pertaining 
to claims and appeals, a description of the rights 
(including deadlines for exercising rights) of partici-
pants, beneficiaries, and enrollees under subtitle A 
in obtaining covered benefits, filing a claim for bene-
fits, and appealing coverage decisions internally and 
externally (including telephone numbers and mailing 
addresses of the appropriate authority), and a de-
scription of any additional legal rights and remedies 
available under section 502 of the Employee Retire-
ment Income Security Act of 1974 and applicable 
State law. 
(14) ADVANCE DIRECTIVES AND ORGAN DONA-
TION.—A description of procedures for advance di-
rectives and organ donation decisions if the plan or 
issuer maintains such procedures. 
(15) INFORMATION ON PLANS AND ISSUERS.— 
The name, mailing address, and telephone number 
or numbers of the plan administrator and the issuer 
to be used by participants, beneficiaries, and enroll-
ees seeking information about plan or coverage bene-
118 
fits and services, payment of a claim, or authoriza-
tion for services and treatment. Notice of whether 
the benefits under the plan or coverage are provided 
under a contract or policy of insurance issued by an 
issuer, or whether benefits are provided directly by 
the plan sponsor who bears the insurance risk. 
(16) TRANSLATION SERVICES.—A summary de-
scription of any translation or interpretation services 
(including the availability of printed information in 
languages other than English, audio tapes, or infor-
mation in Braille) that are available for non-English 
speakers and participants, beneficiaries, and enroll-
ees with communication disabilities and a description 
of how to access these items or services. 
(17) ACCREDITATION INFORMATION.—Any in-
formation that is made public by accrediting organi-
zations in the process of accreditation if the plan or 
issuer is accredited, or any additional quality indica-
tors (such as the results of enrollee satisfaction sur-
veys) that the plan or issuer makes public or makes 
available to participants, beneficiaries, and enrollees. 
(18) NOTICE OF REQUIREMENTS.—A descrip-
tion of any rights of participants, beneficiaries, and 
enrollees that are established by the Patients’ Bill of 
Rights Act of 2005 (excluding those described in