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sure of information or documentary material to 
either body of the Congress or to any duly au-
thorized committee or subcommittee of the Con-
gress. 
‘‘(E) ENFORCEMENT.— 
‘‘(i) CIVIL
PENALTY.—Any person 
that violates a provision of this paragraph 
shall be liable for a civil penalty of not 
more than $11,000 for each day on which 
the violation occurs. Such penalty may be 
recovered in a civil action— 
‘‘(I) brought by the United 
States; or 
‘‘(II) brought by the Federal 
Trade Commission in accordance with 
the procedures established in section 
16(a)(1) of the Federal Trade Com-
mission Act. 
‘‘(ii) COMPLIANCE
AND
EQUITABLE 
RELIEF.—If any person violates any provi-
sion of this paragraph, the United States 
district court may order compliance, and 
may grant such other equitable relief as 
the court in its discretion determines nec-
essary or appropriate, upon application of 
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the Assistant Attorney General or the Fed-
eral Trade Commission. 
‘‘(F) RULEMAKING.—The Federal Trade 
Commission, with the concurrence of the Assist-
ant Attorney General and by rule in accordance 
with section 553 of title 5, United States Code, 
consistent with the purposes of this para-
graph— 
‘‘(i) may define the terms used in this 
paragraph; 
‘‘(ii) may exempt classes of persons or 
agreements from the requirements of this 
paragraph; and 
‘‘(iii) may prescribe such other rules 
as may be necessary and appropriate to 
carry out the purposes of this paragraph. 
‘‘(G) SAVINGS CLAUSE.—Any action taken 
by the Assistant Attorney General or the Fed-
eral Trade Commission, or any failure of the 
Assistant Attorney General or the Commission 
to take action, under this paragraph shall not 
at any time bar any proceeding or any action 
with respect to any agreement between a bio-
similar product applicant under subsection (k) 
and the reference product sponsor, or any 
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agreement between biosimilar product appli-
cants under subsection (k), under any other 
provision of law, nor shall any filing under this 
paragraph constitute or create a presumption of 
any violation of any competition laws.’’. 
(b) DEFINITIONS.—Section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)) is amended— 
(1) by striking ‘‘In this section, the term ‘bio-
logical product’ means’’ and inserting the following: 
‘‘In this section: 
‘‘(1) The term ‘biological product’ means’’; 
(2) in paragraph (1), as so designated, by in-
serting ‘‘protein (except any chemically synthesized 
polypeptide),’’ after ‘‘allergenic product,’’; and 
(3) by adding at the end the following: 
‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 
reference to a biological product that is the subject 
of an application under subsection (k), means— 
‘‘(A) that the biological product is highly 
similar to the reference product notwith-
standing minor differences in clinically inactive 
components; and 
‘‘(B) there are no clinically meaningful dif-
ferences between the biological product and the 
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reference product in terms of the safety, purity, 
and potency of the product. 
‘‘(3) The term ‘interchangeable’ or ‘inter-
changeability’, in reference to a biological product 
that is shown to meet the standards described in 
subsection (k)(4), means that the biological product 
may be substituted for the reference product without 
the intervention of the health care provider who pre-
scribed the reference product. 
‘‘(4) The term ‘reference product’ means the 
single biological product licensed under subsection 
(a) against which a biological product is evaluated in 
an application submitted under subsection (k).’’. 
(c) PRODUCTS PREVIOUSLY APPROVED UNDER SEC-
TION 505.— 
(1) REQUIREMENT TO FOLLOW SECTION 351.— 
Except as provided in paragraph (2), an application 
for a biological product shall be submitted under 
section 351 of the Public Health Service Act (42 
U.S.C. 262) (as amended by this Act). 
(2) EXCEPTION.—An application for a biologi-
cal product may be submitted under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) if— 
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(A) such biological product is in a product 
class for which a biological product in such 
product class is the subject of an application 
approved under such section 505 not later than 
the date of enactment of this Act; and 
(B) such application— 
(i) has been submitted to the Sec-
retary of Health and Human Services (re-
ferred to in this Act as the ‘‘Secretary’’) 
before the date of enactment of this Act; 
or 
(ii) is submitted to the Secretary not 
later than the date that is 10 years after 
the date of enactment of this Act. 
(3) LIMITATION.—Notwithstanding paragraph 
(2), an application for a biological product may not 
be submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) if there is 
another biological product approved under sub-
section (a) of section 351 of the Public Health Serv-
ice Act that could be a reference product with re-
spect to such application (within the meaning of 
such section 351) if such application were submitted 
under subsection (k) of such section 351. 
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(4) DEEMED APPROVED UNDER SECTION 351.— 
An approved application for a biological product 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) shall be deemed to be 
a license for the biological product under such sec-
tion 351 on the date that is 10 years after the date 
of enactment of this Act. 
(5) DEFINITIONS.—For purposes of this sub-
section, the term ‘‘biological product’’ has the mean-
ing given such term under section 351 of the Public 
Health Service Act (42 U.S.C. 262) (as amended by 
this Act). 
SEC. 2576. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subparagraph (B) of section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is 
amended by inserting ‘‘, including licensure of a biological 
product under section 351(k) of such Act’’ before the pe-
riod at the end. 
SEC. 2577. AMENDMENTS TO CERTAIN PATENT PROVI-
SIONS. 
(a) Section 271(e)(2) of title 35, United States Code, 
is amended— 
(1) in subparagraph (A), by striking ‘‘or’’ after 
‘‘patent,’’; 
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(2) in subparagraph (B), by adding ‘‘or’’ after 
the comma at the end; 
(3) by inserting the following after subpara-
graph (B): 
‘‘(C) 
a 
statement 
under 
section 
351(l)(4)(D)(ii) of the Public Health Service 
Act,’’; and 
(4) in the matter following subparagraph (C) 
(as added by paragraph (3)), by inserting before the 
period the following: ‘‘, or if the statement described 
in subparagraph (C) is provided in connection with 
an application to obtain a license to engage in the 
commercial manufacture, use, or sale of a biological 
product claimed in a patent or the use of which is 
claimed in a patent before the expiration of such 
patent’’. 
(b) Section 271(e)(4) of title 35, United States Code, 
is amended by striking ‘‘in paragraph (2)’’ in both places 
it appears and inserting ‘‘in paragraph (2)(A) or (2)(B)’’. 
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Subtitle D—Community Living 
Assistance Services and Supports 
SEC. 2581. ESTABLISHMENT OF NATIONAL VOLUNTARY IN-
SURANCE PROGRAM FOR PURCHASING COM-
MUNITY LIVING ASSISTANCE SERVICES AND 
SUPPORT (CLASS PROGRAM). 
(a) ESTABLISHMENT
OF CLASS PROGRAM.—The 
Public Health Service Act (42 U.S.C. 201 et seq.), as 
amended by section 2301, is amended by adding at the 
end the following: 
‘‘TITLE XXXII—COMMUNITY LIV-
ING 
ASSISTANCE 
SERVICES 
AND SUPPORTS 
‘‘SEC. 3201. PURPOSE. 
‘‘The purpose of this title is to establish a national 
voluntary insurance program for purchasing community 
living assistance services and supports in order to— 
‘‘(1) provide individuals with functional limita-
tions with tools that will allow them to maintain 
their personal and financial independence and live in 
the community through a new financing strategy for 
community living assistance services and supports; 
‘‘(2) establish an infrastructure that will help 
address the Nation’s community living assistance 
services and supports needs; 
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‘‘(3) alleviate burdens on family caregivers; and 
‘‘(4) address institutional bias by providing a fi-
nancing mechanism that supports personal choice 
and independence to live in the community. 
‘‘SEC. 3202. DEFINITIONS. 
‘‘In this title: 
‘‘(1) ACTIVE ENROLLEE.—The term ‘active en-
rollee’ means an individual who is enrolled in the 
CLASS program in accordance with section 3204 
and who has paid any premiums due to maintain 
such enrollment. 
‘‘(2) ACTIVELY EMPLOYED.—The term ‘actively 
employed’ means an individual who— 
‘‘(A) is reporting for work at the individ-
ual’s usual place of employment or at another 
location to which the individual is required to 
travel because of the individual’s employment 
(or in the case of an individual who is a mem-
ber of the uniformed services, is on active duty 
and is physically able to perform the duties of 
the individual’s position); and 
‘‘(B) is able to perform all the usual and 
customary duties of the individual’s employment 
on the individual’s regular work schedule. 
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‘‘(3) ACTIVITIES OF DAILY LIVING.—The term 
‘activities of daily living’ has the meaning given the 
term in section 7702B(c)(2)(B) of the Internal Rev-
enue Code of 1986. 
‘‘(4) CLASS PROGRAM.—The term ‘CLASS 
program’ means the program established under this 
title. 
‘‘(5) ELIGIBILITY ASSESSMENT SYSTEM.—The 
term ‘Eligibility Assessment System’ means the enti-
ty designated by the Secretary under section 
3205(a)(2)(A)(i). 
‘‘(6) ELIGIBLE BENEFICIARY.— 
‘‘(A) IN
GENERAL.—The term ‘eligible 
beneficiary’ means any individual who is an ac-
tive enrollee in the CLASS program and, as of 
the date described in subparagraph (B)— 
‘‘(i) has paid premiums for enrollment 
in such program for at least 60 months; 
‘‘(ii) has earned, for each calendar 
year that occurs during the first 60 
months for which the individual has paid 
premiums for enrollment in the program, 
at least an amount equal to the amount of 
wages and self-employment income which 
an individual must have in order to be 
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credited with a quarter of coverage under 
section 213(d) of the Social Security Act 
for that year; and 
‘‘(iii) has paid premiums for enroll-
ment in such program for at least 24 con-
secutive months, if a lapse in premium 
payments of more than 3 months has oc-
curred during the period that begins on the 
date of the individual’s enrollment and 
ends on the date of such determination. 
‘‘(B) DATE DESCRIBED.—For purposes of 
subparagraph (A), the date described in this 
subparagraph is the date on which the indi-
vidual is determined to have a functional limita-
tion described in section 3203(a)(1)(C) that is 
expected to last for a continuous period of more 
than 90 days. 
‘‘(C) REGULATIONS.—The Secretary shall 
promulgate regulations specifying exceptions to 
the minimum earnings requirements under sub-
paragraph (A)(ii) for purposes of being consid-
ered an eligible beneficiary for certain popu-
lations. 
‘‘(7) HOSPITAL; NURSING
FACILITY; INTER-
MEDIATE CARE FACILITY FOR THE MENTALLY RE-
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TARDED; INSTITUTION
FOR
MENTAL
DISEASES.— 
The terms ‘hospital’, ‘nursing facility’, ‘intermediate 
care facility for the mentally retarded’, and ‘institu-
tion for mental diseases’ have the meanings given 
such terms for purposes of Medicaid. 
‘‘(8) CLASS INDEPENDENCE ADVISORY COUN-
CIL.—The term ‘CLASS Independence Advisory 
Council’ or ‘Council’ means the Advisory Council es-
tablished under section 3207 to advise the Secretary. 
‘‘(9) CLASS INDEPENDENCE BENEFIT PLAN.— 
The term ‘CLASS Independence Benefit Plan’ 
means the benefit plan developed and designated by 
the Secretary in accordance with section 3203. 
‘‘(10) CLASS 
INDEPENDENCE
FUND.—The 
term ‘CLASS Independence Fund’ or ‘Fund’ means 
the fund established under section 3206. 
‘‘(11) MEDICAID.—The term ‘Medicaid’ means 
the program established under title XIX of the So-
cial Security Act. 
‘‘(12) PROTECTION AND ADVOCACY SYSTEM.— 
The term ‘Protection and Advocacy System’ means 
the system for each State established under section 
143 of the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000. 
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‘‘SEC. 3203. CLASS INDEPENDENCE BENEFIT PLAN. 
‘‘(a) PROCESS FOR DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with appropriate actuaries and other experts, 
shall develop at least 3 actuarially sound benefit 
plans as alternatives for consideration for designa-
tion by the Secretary as the CLASS Independence 
Benefit Plan under which eligible beneficiaries shall 
receive benefits under this title. Each of the plan al-
ternatives developed shall be designed to provide eli-
gible beneficiaries with the benefits described in sec-
tion 3205 consistent with the following require-
ments: 
‘‘(A) PREMIUMS.—Beginning with the first 
year of the CLASS program, and for each year 
thereafter, the Secretary shall establish all pre-
miums to be paid by enrollees for the year 
based on an actuarial analysis of the 75-year 
costs of the program that ensures solvency 
throughout such 75-year period. 
‘‘(B) VESTING PERIOD.—A 5-year vesting 
period for eligibility for benefits. 
‘‘(C) BENEFIT TRIGGERS.—A benefit trig-
ger for provision of benefits that requires a de-
termination that an individual has a functional 
limitation, as certified by a licensed health care 
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practitioner, described in any of the following 
clauses that is expected to last for a continuous 
period of more than 90 days: 
‘‘(i) The individual is determined to 
be unable to perform at least the minimum 
number (which may be 2 or 3) of activities 
of daily living as are required under the 
plan for the provision of benefits without 
substantial assistance (as defined by the 
Secretary) from another individual. 
‘‘(ii) The individual requires substan-
tial supervision to protect the individual 
from threats to health and safety due to 
substantial cognitive impairment. 
‘‘(iii) The individual has a level of 
functional limitation similar (as determined 
under regulations prescribed by the Sec-
retary) to the level of functional limitation 
described in clause (i) or (ii). 
‘‘(D) CASH BENEFIT.—Payment of a cash 
benefit that satisfies the following requirements: 
‘‘(i) MINIMUM REQUIRED AMOUNT.— 
The benefit amount provides an eligible 
beneficiary with not less than an average 
of $50 per day (as determined based on 
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the reasonably expected distribution of 
beneficiaries receiving benefits at various 
benefit levels). 
‘‘(ii) AMOUNT
SCALED
TO
FUNC-
TIONAL ABILITY.—The benefit amount is 
varied based on a scale of functional abil-
ity, with not less than 2, and not more 
than 6, benefit level amounts. 
‘‘(iii) DAILY OR WEEKLY.—The ben-
efit is paid on a daily or weekly basis. 
‘‘(iv) NO
LIFETIME
OR
AGGREGATE 
LIMIT.—The benefit is not subject to any 
lifetime or aggregate limit. 
‘‘(2) REVIEW AND RECOMMENDATION BY THE 
CLASS
INDEPENDENCE
ADVISORY
COUNCIL.—The 
CLASS Independence Advisory Council shall— 
‘‘(A) evaluate the alternative benefit plans 
developed under paragraph (1); and 
‘‘(B) recommend for designation as the 
CLASS Independence Benefit Plan for offering 
to the public the plan that the Council deter-
mines best balances price and benefits to meet 
enrollees’ needs in an actuarially sound manner, 
while optimizing the probability of the long- 
term sustainability of the CLASS program. 
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‘‘(3) DESIGNATION BY THE SECRETARY.—Not 
later than October 1, 2012, the Secretary, taking 
into consideration the recommendation of the 
CLASS Independence Advisory Council under para-
graph (2)(B), shall designate a benefit plan as the 
CLASS Independence Benefit Plan. The Secretary 
shall publish such designation, along with details of 
the plan and the reasons for the selection by the 
Secretary, in a final rule that allows for a period of 
public comment. 
‘‘(b) ADDITIONAL PREMIUM REQUIREMENTS.— 
‘‘(1) ADJUSTMENT OF PREMIUMS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B), (C), (D), and (E), the 
amount of the monthly premium determined for 
an individual upon such individual’s enrollment 
in the CLASS program shall remain the same 
for as long as the individual is an active en-
rollee in the program. 
‘‘(B) RECALCULATED
PREMIUM
IF
RE-
QUIRED FOR PROGRAM SOLVENCY.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), if the Secretary determines, based on 
the most recent report of the Board of 
Trustees of the CLASS Independence 
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Fund, the advice of the CLASS Independ-
ence Advisory Council, and the annual re-
port of the Inspector General of the De-
partment of Health and Human Services, 
and waste, fraud, and abuse, or such other 
information as the Secretary determines 
appropriate, that the monthly premiums 
and income to the CLASS Independence 
Fund for a year are projected to be insuffi-
cient with respect to the 20-year period 
that begins with that year, the Secretary 
shall adjust the monthly premiums for in-
dividuals enrolled in the CLASS program 
as necessary. 
‘‘(ii) EXEMPTION FROM INCREASE.— 
Any increase in a monthly premium im-
posed as result of a determination de-
scribed in clause (i) shall not apply with 
respect to the monthly premium of any ac-
tive enrollee who— 
‘‘(I) has attained age 65; 
‘‘(II) has paid premiums for en-
rollment in the program for at least 
20 years; and 
‘‘(III) is not actively employed. 
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‘‘(C) RECALCULATED
PREMIUM
IF
RE-
ENROLLMENT AFTER MORE THAN A 3-MONTH 
LAPSE.— 
‘‘(i) IN GENERAL.—The reenrollment 
of an individual after a 90-day period dur-
ing which the individual failed to pay the 
monthly premium required to maintain the 
individual’s enrollment in the CLASS pro-
gram shall be treated as an initial enroll-
ment for purposes of age-adjusting the 
premium for enrollment in the program. 
‘‘(ii) CREDIT FOR PRIOR MONTHS IF 
REENROLLED WITHIN 5 YEARS.—An indi-
vidual who reenrolls in the CLASS pro-
gram after such a 90-day period and be-
fore the end of the 5-year period that be-
gins with the first month for which the in-
dividual failed to pay the monthly premium 
required to maintain the individual’s en-
rollment in the program shall be— 
‘‘(I) credited with any months of 
paid premiums that accrued prior to 
the individual’s lapse in enrollment; 
and 
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‘‘(II) notwithstanding the total 
amount of any such credited months, 
required 
to 
satisfy 
section 
3202(6)(A)(ii) before being eligible to 
receive benefits. 
‘‘(D) 
PENALTY
FOR
REENROLLMENT 
AFTER 5-YEAR LAPSE.—In the case of an indi-
vidual who reenrolls in the CLASS program 
after the end of the 5-year period described in 
subparagraph (C)(ii), the monthly premium re-
quired for the individual shall be the age-ad-
justed premium that would be applicable to an 
initially enrolling individual who is the same age 
as the reenrolling individual, increased by the 
greater of— 
‘‘(i) an amount that the Secretary de-
termines is actuarially sound for each 
month that occurs during the period that 
begins with the first month for which the 
individual failed to pay the monthly pre-
mium required to maintain the individual’s 
enrollment in the CLASS program and 
ends with the month preceding the month 
in which the reenrollment is effective; or 
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‘‘(ii) 1 percent of the applicable age- 
adjusted premium for each such month oc-
curring in such period. 
‘‘(2) ADMINISTRATIVE
EXPENSES.—In deter-
mining the monthly premiums for the CLASS pro-
gram, the Secretary may factor in costs for admin-
istering the program, not to exceed— 
‘‘(A) in the case of the first 5 years in 
which the program is in effect under this title, 
an amount equal to 3 percent of all premiums 
paid during each such year; and 
‘‘(B) in the case of subsequent years, an 
amount equal to 5 percent of the total amount 
of all expenditures (including benefits paid) 
under this title with respect to that year. 
‘‘(3) NO UNDERWRITING REQUIREMENTS.—No 
underwriting (other than on the basis of age in ac-
cordance with paragraph (2)) shall be used to— 
‘‘(A) determine the monthly premium for 
enrollment in the CLASS program; or 
‘‘(B) prevent an individual from enrolling 
in the program. 
‘‘SEC. 3204. ENROLLMENT AND DISENROLLMENT REQUIRE-
MENTS. 
‘‘(a) AUTOMATIC ENROLLMENT.— 
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‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall establish procedures under which 
each individual described in subsection (c) shall be 
automatically enrolled in the CLASS program by an 
employer of such individual under rules similar to 
the rules of sections 401(k)(13) and 414(w) of the 
Internal Revenue Code of 1986. 
‘‘(2) 
ALTERNATIVE
ENROLLMENT
PROCE-
DURES.—The procedures established under para-
graph (1) shall provide for an alternative enrollment 
process for an individual described in subsection (c) 
in the case of such an individual— 
‘‘(A) who is self-employed; 
‘‘(B) who has more than 1 employer; 
‘‘(C) whose employer does not elect to par-
ticipate in the automatic enrollment process es-
tablished by the Secretary; or 
‘‘(D) who is a spouse described in sub-
section (c)(2) of who is not subject to automatic 
enrollment. 
‘‘(3) ADMINISTRATION.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
by regulation, establish procedures to— 
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‘‘(i) ensure that an individual is not 
automatically enrolled in the CLASS pro-
gram by more than 1 employer; and 
‘‘(ii) allow for an individual’s em-
ployer to deduct a premium for a spouse 
described in subsection (c)(1)(B) who is 
not subject to automatic enrollment. 
‘‘(B) FORM.—Enrollment in the CLASS 
program shall be made in such manner as the 
Secretary may prescribe in order to ensure ease 
of administration. 
‘‘(b) ELECTION TO OPT-OUT.—An individual de-
scribed in subsection (c) may elect to waive enrollment in 
the CLASS program at any time in such form and manner 
as the Secretary shall prescribe. 
‘‘(c) INDIVIDUAL DESCRIBED.—For purposes of en-
rolling in the CLASS program, an individual described in 
this paragraph is— 
‘‘(1) an individual— 
‘‘(A) who has attained age 18; 
‘‘(B) who receives wages on which there is 
imposed a tax under section 3101(a) or 3201(a) 
of the Internal Revenue Code of 1986; 
‘‘(C) who is actively employed; and 
‘‘(D) who is not— 
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‘‘(i) a patient in a hospital or nursing 
facility, an intermediate care facility for 
the mentally retarded, or an institution for 
mental diseases and receiving medical as-
sistance under Medicaid; or 
‘‘(ii) confined in a jail, prison, other 
penal institution or correctional facility, or 
by court order pursuant to conviction of a 
criminal offense or in connection with a 
verdict or finding described in section 
202(x)(1)(A)(ii) of the Social Security Act; 
or 
‘‘(2) the spouse of an individual described in 
paragraph (1) and who would be an individual so de-
scribed but for subparagraph (B) or (C) of that 
paragraph. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this title 
shall be construed as requiring an active enrollee to con-
tinue to satisfy subparagraph (B) or (C) of subsection 
(c)(1) in order to maintain enrollment in the CLASS pro-
gram. 
‘‘(e) PAYMENT.— 
‘‘(1) PAYROLL DEDUCTION.—An amount equal 
to the monthly premium for the enrollment in the 
CLASS program of an individual shall be deducted 
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from the wages of such individual in accordance with 
such procedures as the Secretary shall establish for 
employers who elect to deduct and withhold such 
premiums on behalf of enrolled employees. 
‘‘(2) ALTERNATIVE
PAYMENT
MECHANISM.— 
The Secretary shall establish alternative procedures 
for the payment of monthly premiums by an indi-
vidual enrolled in the CLASS program who does not 
have an employer who elects to deduct and withhold 
premiums in accordance with subparagraph (A). 
‘‘(f) TRANSFER OF PREMIUMS COLLECTED.— 
‘‘(1) IN GENERAL.—During each calendar year 
the Secretary of the Treasury shall deposit into the 
CLASS Independence Fund a total amount equal, in 
the aggregate, to 100 percent of the premiums col-
lected during that year. 
‘‘(2) TRANSFERS BASED ON ESTIMATES.—The 
amount deposited pursuant to paragraph (1) shall be 
transferred in at least monthly payments to the 
CLASS Independence Fund on the basis of esti-
mates by the Secretary and certified to the Sec-
retary of the Treasury of the amounts collected in 
accordance with this section. Proper adjustments 
shall be made in amounts subsequently transferred 
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to the Fund to the extent prior estimates were in ex-
cess of, or were less than, actual amounts collected. 
‘‘(g) OTHER ENROLLMENT
AND DISENROLLMENT 
OPPORTUNITIES.—The Secretary shall establish proce-
dures under which— 
‘‘(1) an individual who, in the year of the indi-
vidual’s initial eligibility to enroll in the CLASS pro-
gram, has elected to waive enrollment in the pro-
gram, is eligible to elect to enroll in the program, in 
such form and manner as the Secretary shall estab-
lish, only during an open enrollment period estab-
lished by the Secretary that is specific to the indi-
vidual and that may not occur more frequently than 
biennially after the date on which the individual first 
elected to waive enrollment in the program; and 
‘‘(2) an individual shall only be permitted to 
disenroll from the program during an annual 
disenrollment period established by the Secretary 
and in such form and manner as the Secretary shall 
establish. 
‘‘SEC. 3205. BENEFITS. 
‘‘(a) DETERMINATION OF ELIGIBILITY.— 
‘‘(1) APPLICATION
FOR
RECEIPT
OF
BENE-
FITS.—The Secretary shall establish procedures 
under which an active enrollee shall apply for receipt 
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of benefits under the CLASS Independence Benefit 
Plan. 
‘‘(2) ELIGIBILITY ASSESSMENTS.— 
‘‘(A) IN GENERAL.—Not later than Janu-
ary 1, 2012, the Secretary shall— 
‘‘(i) designate an entity (other than a 
service with which the Commissioner of So-
cial Security has entered into an agree-
ment, with respect to any State, to make 
disability determinations for purposes of 
title II or XVI of the Social Security Act) 
to serve as an Eligibility Assessment Sys-
tem by providing for eligibility assessments 
of active enrollees who apply for receipt of 
benefits; 
‘‘(ii) enter into an agreement with the 
Protection and Advocacy System for each 
State to provide advocacy services in ac-
cordance with subsection (d); and 
‘‘(iii) enter into an agreement with 
public and private entities to provide ad-
vice and assistance counseling in accord-
ance with subsection (e). 
‘‘(B) REGULATIONS.—The Secretary shall 
promulgate regulations to develop an expedited 
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nationally equitable eligibility determination 
process, as certified by a licensed health care 
practitioner, an appeals process, and a redeter-
mination process, as certified by a licensed 
health care practitioner, including whether an 
applicant is eligible for a cash benefit under the 
program and if so, the amount of the cash ben-
efit (in accordance the sliding scale established 
under the plan). 
‘‘(C) PRESUMPTIVE ELIGIBILITY FOR CER-
TAIN
INSTITUTIONALIZED
ENROLLEES
PLAN-
NING TO DISCHARGE.—An active enrollee shall 
be deemed presumptively eligible if the en-
rollee— 
‘‘(i) has applied for, and attests is eli-
gible for, the maximum cash benefit avail-
able under the sliding scale established 
under the CLASS Independence Benefit 
Plan; 
‘‘(ii) is a patient in a hospital (but 
only if the hospitalization is for long-term 
care), nursing facility, intermediate care 
facility for the mentally retarded, or an in-
stitution for mental diseases; and 
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‘‘(iii) is in the process of, or about to 
being the process of, planning to discharge 
from the hospital, facility, or institution, or 
within 60 days from the date of discharge 
from the hospital, facility, or institution. 
‘‘(D) APPEALS.—The Secretary shall es-
tablish procedures under which an applicant for 
benefits under the CLASS Independence Ben-
efit Plan shall be guaranteed the right to ap-
peal an adverse determination. 
‘‘(b) BENEFITS.—An eligible beneficiary shall receive 
the following benefits under the CLASS Independence 
Benefit Plan: 
‘‘(1) CASH
BENEFIT.—A cash benefit estab-
lished by the Secretary in accordance with the re-
quirements of section 3203(a)(1)(D) that— 
‘‘(A) the first year in which beneficiaries 
receive the benefits under the plan, is not less 
than the average dollar amount specified in 
clause (i) of such section; and 
‘‘(B) for any subsequent year, is not less 
than the average per day dollar limit applicable 
under this subparagraph for the preceding year, 
increased by the percentage increase in the con-
sumer price index for all urban consumers 
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(United States city average) over the previous 
year. 
‘‘(2) ADVOCACY SERVICES.—Advocacy services 
in accordance with subsection (d). 
‘‘(3) ADVICE AND ASSISTANCE COUNSELING.— 
Advice and assistance counseling in accordance with 
subsection (e). 
‘‘(4) ADMINISTRATIVE
EXPENSES.—Advocacy 
services and advise and assistance counseling serv-
ices under paragraphs (2) and (3) of this subsection 
shall be included as administrative expenses under 
section 3203(b)(2). 
‘‘(c) PAYMENT OF BENEFITS.— 
‘‘(1) LIFE INDEPENDENCE ACCOUNT.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish procedures for administering the pro-
vision of benefits to eligible beneficiaries under 
the CLASS Independence Benefit Plan, includ-
ing the payment of the cash benefit for the ben-
eficiary into a Life Independence Account es-
tablished by the Secretary on behalf of each eli-
gible beneficiary. 
‘‘(B) USE OF CASH BENEFITS.—Cash ben-
efits paid into a Life Independence Account of 
an eligible beneficiary shall be used to purchase 
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nonmedical services and supports that the bene-
ficiary needs to maintain his or her independ-
ence at home or in another residential setting 
of their choice in the community, including (but 
not limited to) home modifications, assistive 
technology, accessible transportation, home-
maker services, respite care, personal assistance 
services, home care aides, and nursing support. 
Nothing in the preceding sentence shall prevent 
an eligible beneficiary from using cash benefits 
paid into a Life Independence Account for ob-
taining assistance with decisionmaking con-
cerning medical care, including the right to ac-
cept or refuse medical or surgical treatment 
and the right to formulate advance directives or 
other written instructions recognized under 
State law, such as a living will or durable power 
of attorney for health care, in the case that an 
injury or illness causes the individual to be un-
able to make health care decisions. 
‘‘(C) 
ELECTRONIC
MANAGEMENT
OF 
FUNDS.—The Secretary shall establish proce-
dures for— 
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‘‘(i) crediting an account established 
on behalf of a beneficiary with the bene-
ficiary’s cash daily benefit; 
‘‘(ii) allowing the beneficiary to access 
such account through debit cards; and 
‘‘(iii) accounting for withdrawals by 
the beneficiary from such account. 
‘‘(D) PRIMARY PAYOR RULES FOR BENE-
FICIARIES WHO ARE ENROLLED IN MEDICAID.— 
In the case of an eligible beneficiary who is en-
rolled in Medicaid, the following payment rules 
shall apply: 
‘‘(i) 
INSTITUTIONALIZED
BENE-
FICIARY.—If the beneficiary is a patient in 
a hospital, nursing facility, intermediate 
care facility for the mentally retarded, or 
an institution for mental diseases, the ben-
eficiary shall retain an amount equal to 5 
percent of the beneficiary’s daily or weekly 
cash benefit (as applicable) (which shall be 
in addition to the amount of the bene-
ficiary’s personal needs allowance provided 
under Medicaid), and the remainder of 
such benefit shall be applied toward the fa-
cility’s cost of providing the beneficiary’s 
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care, and Medicaid shall provide secondary 
coverage for such care. 
‘‘(ii) 
BENEFICIARIES
RECEIVING 
HOME
AND
COMMUNITY-BASED
SERV-
ICES.— 
‘‘(I) 50 PERCENT
OF
BENEFIT 
RETAINED BY BENEFICIARY.—Subject 
to subclause (II), if a beneficiary is 
receiving medical assistance under 
Medicaid for home and community- 
based services, the beneficiary shall 
retain an amount equal to 50 percent 
of the beneficiary’s daily or weekly 
cash benefit (as applicable), and the 
remainder of the daily or weekly cash 
benefit shall be applied toward the 
cost to the State of providing such as-
sistance (and shall not be used to 
claim Federal matching funds under 
Medicaid), and Medicaid shall provide 
secondary coverage for the remainder 
of any costs incurred in providing 
such assistance. 
‘‘(II) REQUIREMENT FOR STATE 
OFFSET.—A State shall be paid the 
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remainder of a beneficiary’s daily or 
weekly cash benefit under subclause 
(I) only if the State home and com-
munity-based waiver under section 
1115 of the Social Security Act or 
subsection (c) or (d) of section 1915 
of such Act, or the State plan amend-
ment under subsection (i) of such sec-
tion does not include a waiver of the 
requirements of section 1902(a)(1) of 
the Social Security Act (relating to 
statewideness) 
or 
of 
section 
1902(a)(10)(B) of such Act (relating 
to comparability) and the State offers 
at a minimum case management serv-
ices, personal care services, habili-
tation services, and respite care under 
such a waiver or State plan amend-
ment. 
‘‘(III) DEFINITION OF HOME AND 
COMMUNITY-BASED
SERVICES.—In 
this clause, the term ‘home and com-
munity-based services’ means any 
services which may be offered under a 
home and community-based waiver 
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authorized for a State under section 
1115 of the Social Security Act or 
subsection (c) or (d) of section 1915 
of such Act or under a State plan 
amendment under subsection (i) of 
such section. 
‘‘(iii) BENEFICIARIES
ENROLLED
IN 
PROGRAMS OF ALL-INCLUSIVE CARE FOR 
THE ELDERLY (PACE).— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), if a beneficiary is re-
ceiving medical assistance under Med-
icaid for PACE program services 
under section 1934 of the Social Secu-
rity Act, the beneficiary shall retain 
an amount equal to 50 percent of the 
beneficiary’s daily or weekly cash ben-
efit (as applicable), and the remainder 
of the daily or weekly cash benefit 
shall be applied toward the cost to the 
State of providing such assistance 
(and shall not be used to claim Fed-
eral matching funds under Medicaid), 
and Medicaid shall provide secondary 
coverage for the remainder of any 
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costs incurred in providing such as-
sistance. 
‘‘(II) 
INSTITUTIONALIZED
RE-
CIPIENTS
OF
PACE
PROGRAM
SERV-
ICES.—If a beneficiary receiving as-
sistance under Medicaid for PACE 
program services is a patient in a hos-
pital, nursing facility, intermediate 
care facility for the mentally retarded, 
or an institution for mental diseases, 
the beneficiary shall be treated as in 
institutionalized 
beneficiary 
under 
clause (i). 
‘‘(2) AUTHORIZED REPRESENTATIVES.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish procedures to allow access to a bene-
ficiary’s cash benefits by an authorized rep-
resentative of the eligible beneficiary on whose 
behalf such benefits are paid. 
‘‘(B) QUALITY ASSURANCE AND PROTEC-
TION AGAINST FRAUD AND ABUSE.—The proce-
dures established under subparagraph (A) shall 
ensure that authorized representatives of eligi-
ble beneficiaries comply with standards of con-
duct established by the Secretary, including 
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standards requiring that such representatives 
provide quality services on behalf of such bene-
ficiaries, do not have conflicts of interest, and 
do not misuse benefits paid on behalf of such 
beneficiaries or otherwise engage in fraud or 
abuse. 
‘‘(3) COMMENCEMENT OF BENEFITS.—Benefits 
shall be paid to, or on behalf of, an eligible bene-
ficiary beginning with the first month in which an 
application for such benefits is approved. 
‘‘(4) ROLLOVER OPTION FOR LUMP-SUM PAY-
MENT.—An eligible beneficiary may elect to— 
‘‘(A) defer payment of their daily or weekly 
benefit and to rollover any such deferred bene-
fits from month-to-month, but not from year-to- 
year; and 
‘‘(B) receive a lump-sum payment of such 
deferred benefits in an amount that may not 
exceed the lesser of— 
‘‘(i) the total amount of the accrued 
deferred benefits; or 
‘‘(ii) the applicable annual benefit. 
‘‘(5) PERIOD FOR DETERMINATION OF ANNUAL 
BENEFITS.— 
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‘‘(A) IN GENERAL.—The applicable period 
for determining with respect to an eligible bene-
ficiary the applicable annual benefit and the 
amount of any accrued deferred benefits is the 
12-month period that commences with the first 
month in which the beneficiary began to receive 
such benefits, and each 12-month period there-
after. 
‘‘(B) INCLUSION
OF
INCREASED
BENE-
FITS.—The Secretary shall establish procedures 
under which cash benefits paid to an eligible 
beneficiary that increase or decrease as a result 
of a change in the functional status of the bene-
ficiary before the end of a 12-month benefit pe-
riod shall be included in the determination of 
the applicable annual benefit paid to the eligible 
beneficiary. 
‘‘(C) RECOUPMENT OF UNPAID, ACCRUED 
BENEFITS.— 
‘‘(i) IN GENERAL.—The Secretary, in 
coordination with the Secretary of the 
Treasury, shall recoup any accrued bene-
fits in the event of— 
‘‘(I) the death of a beneficiary; or 
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