H. R. 3590—707 
‘‘(vi) The imposition of sanctions in the form of 
civil monetary penalties, which— 
‘‘(I) shall be assessed according to standards 
established in regulations to be promulgated by 
the Secretary not later than 180 days after the 
date of enactment of the Patient Protection and 
Affordable Care Act; 
‘‘(II) shall not exceed $5,000 for each instance 
of overcharging a covered entity that may have 
occurred; and 
‘‘(III) shall apply to any manufacturer with 
an agreement under this section that knowingly 
and intentionally charges a covered entity a price 
for purchase of a drug that exceeds the maximum 
applicable price under subsection (a)(1). 
‘‘(2) COVERED ENTITY COMPLIANCE.— 
‘‘(A) IN GENERAL.—From amounts appropriated under 
paragraph (4), the Secretary shall provide for improve-
ments in compliance by covered entities with the require-
ments of this section in order to prevent diversion and 
violations of the duplicate discount provision and other 
requirements specified under subsection (a)(5). 
‘‘(B) IMPROVEMENTS.—The improvements described in 
subparagraph (A) shall include the following: 
‘‘(i) The development of procedures to enable and 
require covered entities to regularly update (at least 
annually) the information on the Internet website of 
the Department of Health and Human Services 
relating to this section. 
‘‘(ii) The development of a system for the Secretary 
to verify the accuracy of information regarding covered 
entities that is listed on the website described in clause 
(i). 
‘‘(iii) The development of more detailed guidance 
describing methodologies and options available to cov-
ered entities for billing covered drugs to State Medicaid 
agencies in a manner that avoids duplicate discounts 
pursuant to subsection (a)(5)(A). 
‘‘(iv) The establishment of a single, universal, and 
standardized identification system by which each cov-
ered entity site can be identified by manufacturers, 
distributors, covered entities, and the Secretary for 
purposes of facilitating the ordering, purchasing, and 
delivery of covered drugs under this section, including 
the processing of chargebacks for such drugs. 
‘‘(v) The imposition of sanctions, in appropriate 
cases as determined by the Secretary, additional to 
those to which covered entities are subject under sub-
section (a)(5)(E), through one or more of the following 
actions: 
‘‘(I) Where a covered entity knowingly and 
intentionally violates subsection (a)(5)(B), the cov-
ered entity shall be required to pay a monetary 
penalty to a manufacturer or manufacturers in 
the form of interest on sums for which the covered 
entity is found liable under subsection (a)(5)(E), 
such interest to be compounded monthly and equal
H. R. 3590—708 
to the current short term interest rate as deter-
mined by the Federal Reserve for the time period 
for which the covered entity is liable. 
‘‘(II) Where the Secretary determines a viola-
tion of subsection (a)(5)(B) was systematic and 
egregious as well as knowing and intentional, 
removing the covered entity from the drug discount 
program under this section and disqualifying the 
entity from re-entry into such program for a 
reasonable period of time to be determined by the 
Secretary. 
‘‘(III) Referring matters to appropriate Federal 
authorities within the Food and Drug Administra-
tion, the Office of Inspector General of Department 
of Health and Human Services, or other Federal 
agencies for consideration of appropriate action 
under other Federal statutes, such as the Prescrip-
tion Drug Marketing Act (21 U.S.C. 353). 
‘‘(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.— 
‘‘(A) IN GENERAL.—Not later than 180 days after the 
date of enactment of the Patient Protection and Affordable 
Care Act, the Secretary shall promulgate regulations to 
establish and implement an administrative process for the 
resolution of claims by covered entities that they have 
been overcharged for drugs purchased under this section, 
and claims by manufacturers, after the conduct of audits 
as authorized by subsection (a)(5)(D), of violations of sub-
sections (a)(5)(A) or (a)(5)(B), including appropriate proce-
dures for the provision of remedies and enforcement of 
determinations made pursuant to such process through 
mechanisms and sanctions described in paragraphs (1)(B) 
and (2)(B). 
‘‘(B) 
DEADLINES
AND
PROCEDURES.—Regulations 
promulgated by the Secretary under subparagraph (A) 
shall— 
‘‘(i) designate or establish a decision-making offi-
cial or decision-making body within the Department 
of Health and Human Services to be responsible for 
reviewing and finally resolving claims by covered enti-
ties that they have been charged prices for covered 
drugs in excess of the ceiling price described in sub-
section (a)(1), and claims by manufacturers that viola-
tions of subsection (a)(5)(A) or (a)(5)(B) have occurred; 
‘‘(ii) establish such deadlines and procedures as 
may be necessary to ensure that claims shall be 
resolved fairly, efficiently, and expeditiously; 
‘‘(iii) establish procedures by which a covered 
entity may discover and obtain such information and 
documents from manufacturers and third parties as 
may be relevant to demonstrate the merits of a claim 
that charges for a manufacturer’s product have 
exceeded the applicable ceiling price under this section, 
and may submit such documents and information to 
the administrative official or body responsible for adju-
dicating such claim; 
‘‘(iv) require that a manufacturer conduct an audit 
of a covered entity pursuant to subsection (a)(5)(D)
H. R. 3590—709 
as a prerequisite to initiating administrative dispute 
resolution proceedings against a covered entity; 
‘‘(v) permit the official or body designated under 
clause (i), at the request of a manufacturer or manufac-
turers, to consolidate claims brought by more than 
one manufacturer against the same covered entity 
where, in the judgment of such official or body, consoli-
dation is appropriate and consistent with the goals 
of fairness and economy of resources; and 
‘‘(vi) include provisions and procedures to permit 
multiple covered entities to jointly assert claims of 
overcharges by the same manufacturer for the same 
drug or drugs in one administrative proceeding, and 
permit such claims to be asserted on behalf of covered 
entities by associations or organizations representing 
the interests of such covered entities and of which 
the covered entities are members. 
‘‘(C) FINALITY
OF
ADMINISTRATIVE
RESOLUTION.—The 
administrative resolution of a claim or claims under the 
regulations promulgated under subparagraph (A) shall be 
a final agency decision and shall be binding upon the 
parties involved, unless invalidated by an order of a court 
of competent jurisdiction. 
‘‘(4) 
AUTHORIZATION
OF
APPROPRIATIONS.—There 
are 
authorized to be appropriated to carry out this subsection, 
such sums as may be necessary for fiscal year 2010 and each 
succeeding fiscal year.’’. 
(b) CONFORMING AMENDMENTS.—Section 340B(a) of the Public 
Health Service Act (42 U.S.C. 256b(a)) is amended— 
(1) in subsection (a)(1), by adding at the end the following: 
‘‘Each such agreement shall require that the manufacturer 
furnish the Secretary with reports, on a quarterly basis, of 
the price for each covered drug subject to the agreement that, 
according to the manufacturer, represents the maximum price 
that covered entities may permissibly be required to pay for 
the drug (referred to in this section as the ‘ceiling price’), 
and shall require that the manufacturer offer each covered 
entity covered drugs for purchase at or below the applicable 
ceiling price if such drug is made available to any other pur-
chaser at any price.’’; and 
(2) in the first sentence of subsection (a)(5)(E), as redesig-
nated by section 7101(c), by inserting ‘‘after audit as described 
in subparagraph (D) and’’ after ‘‘finds,’’. 
SEC. 7103. GAO STUDY TO MAKE RECOMMENDATIONS ON IMPROVING 
THE 340B PROGRAM. 
(a) REPORT.—Not later than 18 months after the date of enact-
ment of this Act, the Comptroller General of the United States 
shall submit to Congress a report that examines whether those 
individuals served by the covered entities under the program under 
section 340B of the Public Health Service Act (42 U.S.C. 256b) 
(referred to in this section as the ‘‘340B program’’) are receiving 
optimal health care services. 
(b) RECOMMENDATIONS.—The report under subsection (a) shall 
include recommendations on the following:
H. R. 3590—710 
(1) Whether the 340B program should be expanded since 
it is anticipated that the 47,000,000 individuals who are unin-
sured as of the date of enactment of this Act will have health 
care coverage once this Act is implemented. 
(2) Whether mandatory sales of certain products by the 
340B program could hinder patients access to those therapies 
through any provider. 
(3) Whether income from the 340B program is being used 
by the covered entities under the program to further the pro-
gram objectives. 
TITLE VIII—CLASS ACT 
SEC. 8001. SHORT TITLE OF TITLE. 
This title may be cited as the ‘‘Community Living Assistance 
Services and Supports Act’’ or the ‘‘CLASS Act’’. 
SEC. 8002. ESTABLISHMENT OF NATIONAL VOLUNTARY INSURANCE 
PROGRAM 
FOR 
PURCHASING 
COMMUNITY 
LIVING 
ASSISTANCE SERVICES AND SUPPORT. 
(a) ESTABLISHMENT OF CLASS PROGRAM.— 
(1) IN GENERAL.—The Public Health Service Act (42 U.S.C. 
201 et seq.), as amended by section 4302(a), is amended by 
adding at the end the following: 
‘‘TITLE XXXII—COMMUNITY LIVING 
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 serv-
ices and supports in order to— 
‘‘(1) provide individuals with functional limitations with 
tools that will allow them to maintain their personal and finan-
cial 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; 
‘‘(3) alleviate burdens on family caregivers; and 
‘‘(4) address institutional bias by providing a financing 
mechanism that supports personal choice and independence 
to live in the community. 
‘‘SEC. 3202. DEFINITIONS. 
‘‘In this title: 
‘‘(1) ACTIVE ENROLLEE.—The term ‘active enrollee’ means 
an individual who is enrolled in the CLASS program in accord-
ance 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 individual’s usual 
place of employment or at another location to which the