936 
group health plan, means the amount spent by a 
group health plan on prescription drug benefits, cal-
culated after the application of rebates, fees, alter-
native discounts, or other remuneration. 
‘‘(6) PLAN SPONSOR.—The term ‘plan sponsor’ 
has the meaning given such term in section 3(16)(B) 
of the Employee Retirement Income Security Act of 
1974 (29 U.S.C. 1002(16)(B)). 
‘‘(7) REMUNERATION.—The term ‘remunera-
tion’ has the meaning given such term by the Sec-
retary, through rulemaking, which shall be reevalu-
ated by the Secretary every 5 years. 
‘‘(8) SPECIFIED LARGE EMPLOYER.—The term 
‘specified large employer’ means, in connection with 
a group health plan established or maintained by a 
single employer, with respect to a calendar year or 
a plan year, as applicable, an employer who em-
ployed an average of at least 100 employees on busi-
ness days during the preceding calendar year or plan 
year and who employs at least 1 employee on the 
first day of the calendar year or plan year. 
‘‘(9) SPECIFIED LARGE PLAN.—The term ‘spec-
ified large plan’ means a group health plan estab-
lished or maintained by a plan sponsor described in 
clause (ii) or (iii) of section 3(16)(B) of the Em-
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937 
ployee Retirement Income Security Act of 1974 (29 
U.S.C. 1002(16)(B)) that had an average of at least 
100 participants on business days during the pre-
ceding calendar year or plan year, as applicable. 
‘‘(10) WHOLESALE
ACQUISITION
COST.—The 
term ‘wholesale acquisition cost’ has the meaning 
given such term in section 1847A(c)(6)(B) of the 
Social 
Security 
Act 
(42 
U.S.C. 
1395w– 
3a(c)(6)(B)).’’; 
(2) EXCEPTION FOR CERTAIN GROUP HEALTH 
PLANS.—Section 9831(a)(2) of the Internal Revenue 
Code of 1986 is amended by inserting ‘‘other than 
with respect to section 9826,’’ before ‘‘any group 
health plan’’. 
(3) ENFORCEMENT.—Section 4980D of the In-
ternal Revenue Code of 1986 is amended by adding 
at the end the following new subsection: 
‘‘(g) APPLICATION TO REQUIREMENTS IMPOSED ON 
CERTAIN
ENTITIES
PROVIDING
PHARMACY
BENEFIT 
MANAGEMENT SERVICES.—In the case of any requirement 
under section 9826 that applies with respect to an entity 
providing pharmacy benefit management services on be-
half of a group health plan, any reference in this section 
to such group health plan (and the reference in subsection 
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938 
(e)(1) to the employer) shall be treated as including a ref-
erence to such entity.’’. 
(4) CLERICAL AMENDMENT.—The table of sec-
tions for subchapter B of chapter 100 of the Inter-
nal Revenue Code of 1986 is amended by adding at 
the end the following new item: 
‘‘Sec. 9826. Oversight of entities that provide pharmacy benefit management 
services.’’. 
SEC. 6702. FULL REBATE PASS THROUGH TO PLAN; EXCEP-
TION FOR INNOCENT PLAN FIDUCIARIES. 
(a) IN GENERAL.—Section 408(b)(2) of the Em-
ployee Retirement Income Security Act of 1974 (29 
U.S.C. 1108(b)(2)) is amended— 
(1) in subparagraph (B)(viii)— 
(A) 
by 
redesignating 
subclauses 
(II) 
through (IV) as subclauses (III) through (V), 
respectively; 
(B) in subclause (I)— 
(i) by striking ‘‘subclause (II)’’ and 
inserting ‘‘subclause (III)’’; and 
(ii) by striking ‘‘subclauses (II) and 
(III)’’ and inserting ‘‘subclauses (III) and 
(IV)’’; and 
(C) by inserting after subclause (I) the fol-
lowing: 
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939 
‘‘(II) Pursuant to subsection (a), subpara-
graphs (C) and (D) of section 406(a)(1) shall not 
apply to a responsible plan fiduciary, notwith-
standing any failure to remit required amounts 
under subparagraph (C)(i), if the following condi-
tions are met: 
‘‘(aa) The responsible plan fiduciary did 
not know that the covered service provider 
failed or would fail to make required remit-
tances and reasonably believed that the covered 
service 
provider 
remitted 
such 
required 
amounts. 
‘‘(bb) The responsible plan fiduciary, upon 
discovering that the covered service provider 
failed to remit the required amounts, requests 
in writing that the covered service provider 
remit such amounts. 
‘‘(cc) If the covered service provider fails 
to comply with a written request described in 
subclause (III) within 90 days of the request, 
the responsible plan fiduciary notifies the Sec-
retary of the covered service provider’s failure, 
in accordance with subclauses (III) and (IV).’’; 
and 
(2) by adding at the end the following: 
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940 
‘‘(C)(i)(I) For plan years beginning on or after 
the date that is 30 months after the date of enact-
ment of this subparagraph (referred to in this clause 
as the ‘effective date’), no contract or arrangement 
or renewal or extension of a contract or arrange-
ment, entered into on or after the effective date, for 
services between a covered plan and a covered serv-
ice provider (or between a sponsor of a covered plan 
and a covered service provider), through a health in-
surance issuer offering group health insurance cov-
erage, a third-party administrator, an entity pro-
viding pharmacy benefit management services, or 
other entity, for pharmacy benefit management serv-
ices, is reasonable within the meaning of this para-
graph unless such entity providing pharmacy benefit 
management services— 
‘‘(aa) remits 100 percent of rebates, fees, 
alternative discounts, and other remuneration 
received from any applicable entity that are re-
lated to utilization of drugs or drug spending 
under such health plan or health insurance cov-
erage, to the group health plan or, in the case 
of a health insurance issuer offering group 
health insurance coverage in connection with a 
group health plan, to the health insurance 
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941 
issuer offering group health insurance coverage 
on behalf of the plan; and 
‘‘(bb) does not enter into any contract for 
pharmacy benefit management services on be-
half of such a plan or coverage, with an applica-
ble entity unless 100 percent of rebates, fees, 
alternative discounts, and other remuneration 
received under such contract that are related to 
the utilization of drugs or drug spending under 
such group health plan or health insurance cov-
erage are remitted to the group health plan or, 
in the case of a health insurance issuer offering 
group health insurance coverage in connection 
with a group health plan, to the health insur-
ance issuer on behalf of the plan by the entity 
providing pharmacy benefit management serv-
ices. 
‘‘(II) Nothing in subclause (I) shall be con-
strued to affect the term of a contract or arrange-
ment, as in effect on the effective date (as described 
in such subclause), except that such subclause shall 
apply to any renewal or extension of such a contract 
or arrangement entered into on or after such effec-
tive date, as so described. 
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942 
‘‘(ii) With respect to such rebates, fees, alternative 
discounts, and other remuneration— 
‘‘(I) the rebates, fees, alternative discounts, and 
other remuneration under clause (i)(I) shall be— 
‘‘(aa) remitted— 
‘‘(AA) on a quarterly basis, to the 
group health plan or, in the case of a 
health insurance issuer offering group 
health insurance coverage in connection 
with a group health plan, to the group 
health insurance issuer on behalf of the 
plan, not later than 90 days after the end 
of each quarter; or 
‘‘(BB) in the case of an under-
payment in a remittance for a prior quar-
ter, as soon as practicable, but not later 
than 90 days after notice of the under-
payment is first given; 
‘‘(bb) fully disclosed and enumerated to 
the group health plan or health insurance 
issuer; and 
‘‘(cc) returned to the covered service pro-
vider for pharmacy benefit management services 
on behalf of the group health plan if any audit 
by a plan sponsor, issuer or a third party des-
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943 
ignated by a plan sponsor, indicates that the 
amounts received are in excess of correct 
amounts after such amounts have been paid to 
the group health plan, in the amount of such 
excess; 
‘‘(II) the Secretary may issue regulations gov-
erning— 
‘‘(aa) procedures for the remittance of re-
bates, fees, alternative discounts, and other re-
muneration under subclause (I)(aa); 
‘‘(bb) any audit pursuant to this subpara-
graph; and 
‘‘(cc) the timing, manner, and content of 
the disclosure of rebates, fees, alternative dis-
counts, and other remuneration under subclause 
(I)(bb) as well as any other information the 
Secretary determines necessary for the respon-
sible plan fiduciary to consider the reasonable-
ness of the contract or arrangement (provided 
that such information does not include person-
ally identifiable health information or protected 
health information subject to established indi-
vidual privacy and nondiscrimination require-
ments under law); and 
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944 
‘‘(III) the records of such rebates, fees, alter-
native discounts, other remuneration, and disclo-
sures, shall be available for audit by the plan (or the 
plan sponsor, issuer, or a third party designated by 
a plan sponsor on behalf of the plan), not less than 
once per plan year. 
‘‘(iii) To ensure that an entity providing pharmacy 
benefit management services is able to meet the require-
ments of clause (ii)(I), a rebate aggregator (or other pur-
chasing entity designed to aggregate rebates) and an ap-
plicable group purchasing organization shall remit such re-
bates to the entity providing pharmacy benefit manage-
ment services not later than 45 days after the end of each 
quarter. 
‘‘(iv) A third-party administrator of a group health 
plan, a health insurance issuer offering group health in-
surance coverage, or a covered service provider for phar-
macy benefit management services under such health plan 
or health insurance coverage shall make rebate contracts 
with rebate aggregators or drug manufacturers available 
for audit by such plan, subject to reasonable restrictions 
(as determined by the Secretary) on confidentiality to pre-
vent re-disclosure of such contracts or use of such infor-
mation in audits for purposes unrelated to this section. 
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945 
‘‘(v) Audits carried out under clauses (ii)(III) and 
(iv) shall be performed by an auditor selected by the re-
sponsible plan fiduciary. Payment for such auditors shall 
not be made, whether directly or indirectly, by the entity 
providing pharmacy benefit management services. 
‘‘(vi) Nothing in this subparagraph shall be construed 
to— 
‘‘(I) prohibit reasonable payments to entities of-
fering pharmacy benefit management services for 
bona fide services using a fee structure not described 
in this subparagraph, provided that such fees are 
transparent and quantifiable to group health plans 
and health insurance issuers; 
‘‘(II) require a third-party administrator of a 
group health plan or covered service provider for 
pharmacy benefit management services under such 
health plan or health insurance coverage to remit 
bona fide service fees to the group health plan; 
‘‘(III) limit the ability of a group health plan or 
health insurance issuer to pass through rebates, 
fees, alternative discounts, and other remuneration 
to the participant or beneficiary; 
‘‘(IV) modify the requirements for the creation, 
receipt, maintenance, or transmission of protected 
health information under the privacy regulations 
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946 
promulgated under the Health Insurance Portability 
and Accountability Act of 1996 in part 160 and sub-
parts A and E of part 164 of title 45, Code of Fed-
eral Regulations (or successor regulations); or 
‘‘(V) limit any requirement under subparagraph 
(A) or (B). 
‘‘(vii) For purposes of this subparagraph— 
‘‘(I) the terms ‘applicable entity’ and ‘applicable 
group purchasing organization’ have the meanings 
given such terms in section 726(e); 
‘‘(II) the terms ‘covered plan’, ‘covered service 
provider’, and ‘responsible plan fiduciary’ have the 
meanings given such terms in subparagraph (B); 
and 
‘‘(III) the terms ‘group health insurance cov-
erage’, ‘health insurance coverage’, and ‘health in-
surance issuer’ have the meanings given such terms 
in section 733.’’. 
(b) RULE OF CONSTRUCTION.—Subclause (II)(aa) of 
section 408(b)(2)(B)(viii) of the Employee Retirement In-
come 
Security 
Act 
of 
1974 
(29 
U.S.C. 
1108(b)(2)(B)(viii)), as amended by subsection (a), shall 
not be construed to relieve or limit a responsible plan fidu-
ciary from the duty to monitor the practices of any covered 
service provider that contracts with the applicable covered 
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947 
plan, including for the purposes of ensuring the reason-
ableness of compensation. For purposes of this subsection, 
the terms ‘‘covered plan’’, ‘‘covered service provider’’, and 
‘‘responsible plan fiduciary’’ have the meanings given such 
terms in section 408(b)(2)(B)(ii) of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C. 
1108(b)(2)(B)(ii)). 
(c) CLARIFICATION
OF COVERED SERVICE PRO-
VIDER.— 
(1) SERVICES.—Section 408(b)(2)(B)(ii)(I)(bb) 
of the Employee Retirement Income Security Act of 
1974 (29 U.S.C. 1108(b)(2)(B)(ii)(I)(bb)) is amend-
ed— 
(A) in subitem (AA) by striking ‘‘Broker-
age services,’’ and inserting ‘‘Services (includ-
ing brokerage services),’’; and 
(B) in subitem (BB)— 
(i) by striking ‘‘Consulting,’’ and in-
serting ‘‘Other services,’’; and 
(ii) by striking ‘‘related to the devel-
opment or implementation of plan design’’ 
and all that follows through the period at 
the end and inserting ‘‘including any of the 
following: plan design, insurance or insur-
ance product selection (including vision 
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948 
and dental), recordkeeping, medical man-
agement, benefits administration selection 
(including vision and dental), stop-loss in-
surance, pharmacy benefit management 
services, wellness design and management 
services, transparency tools, group pur-
chasing organization agreements and serv-
ices, participation in and services from pre-
ferred vendor panels, disease management, 
compliance services, employee assistance 
programs, or third-party administration 
services, or consulting services related to 
any such services.’’. 
(2) CERTAIN ARRANGEMENTS FOR PHARMACY 
BENEFIT MANAGEMENT SERVICES CONSIDERED AS 
INDIRECT.— 
(A) IN GENERAL.—Section 408(b)(2)(B)(i) 
of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1108(b)(2)(B)(i)) is 
amended— 
(i) by striking ‘‘requirements of this 
clause’’ and inserting ‘‘requirements of this 
subparagraph’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘For purposes of applying section 
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949 
406(a)(1)(C) with respect to a transaction 
described under this subparagraph or sub-
paragraph (C), a contract or arrangement 
for services between a covered plan and an 
entity providing services to the plan, in-
cluding a health insurance issuer providing 
health insurance coverage in connection 
with the covered plan, in which such entity 
contracts, in connection with such plan, 
with a service provider for pharmacy ben-
efit management services, shall be consid-
ered an indirect furnishing of goods, serv-
ices, or facilities between the covered plan 
and the service provider for pharmacy ben-
efit management services acting as the 
party in interest.’’. 
(B) EXEMPTION.—Section 408(b)(2)(B) 
(29 U.S.C. 1108(b)(2)(B)) of such Act is 
amended by adding at the end the following: 
‘‘(x) A service provider for pharmacy benefit 
management services that is considered to indirectly 
furnish goods, services, or facilities to a covered 
plan, as described in clause (i)(I), is entitled to relief 
with respect to a violation of this section provided 
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950 
the conditions for receiving such relief are satis-
fied.’’. 
(C) HEALTH
INSURANCE
ISSUER
AND 
HEALTH
INSURANCE
COVERAGE
DEFINED.— 
Section 408(b)(2)(B)(ii)(I)(aa) of such Act (29 
U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is amended by 
inserting before the period at the end ‘‘and the 
terms ‘health insurance coverage’ and ‘health 
insurance issuer’ have the meanings given such 
terms in section 733(b)’’. 
(D) 
TECHNICAL
AMENDMENT.—Section 
408(b)(2)(B)(ii)(I)(aa) of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C. 
1108(b)(2)(B)(ii)(I)(aa)) is amended by insert-
ing ‘‘in’’ after ‘‘defined’’. 
(E) REGULATORY
AUTHORITY.—Section 
408(b)(2)(B)(iii) of such Act (29 U.S.C. 
1108(b)(2)(B)(iii)) is amended, in the matter 
preceding subclause (I), by inserting ‘‘(in ac-
cordance with regulations issued by the Sec-
retary addressing time, manner, and content of 
such disclosures)’’, after ‘‘following’’. 
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951 
SEC. 6703. INCREASING TRANSPARENCY IN GENERIC DRUG 
APPLICATIONS. 
(a) IN GENERAL.—Section 505(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 
amended by adding at the end the following: 
‘‘(H)(i) Upon request (in controlled correspondence 
or an analogous process) by a person that has submitted 
or intends to submit an abbreviated application under this 
subsection for a drug that is required by regulation to con-
tain one or more of the same inactive ingredients in the 
same concentrations as the listed drug referred to, or for 
which the Secretary determines there is a scientific jus-
tification for an approach that is in vitro, in whole or in 
part, to be used to demonstrate bioequivalence for a drug 
if such a drug contains one or more of the same inactive 
ingredients in the same concentrations as the listed drug 
referred to, the Secretary shall inform the person whether 
such drug is qualitatively and quantitatively the same as 
the listed drug. The Secretary may also provide such infor-
mation to such a person on the Secretary’s own initiative 
during the review of an abbreviated application under this 
subsection for such drug. 
‘‘(ii) Notwithstanding section 301(j), if the Secretary 
determines that such drug is not qualitatively or quan-
titatively the same as the listed drug, the Secretary shall 
identify and disclose to the person— 
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952 
‘‘(I) the ingredient or ingredients that cause such 
drug not to be qualitatively or quantitatively the same as 
the listed drug; and 
‘‘(II) for any ingredient for which there is an identi-
fied quantitative deviation, the amount of such deviation. 
‘‘(iii) If the Secretary determines that such drug is 
qualitatively and quantitatively the same as the listed 
drug, the Secretary shall not change or rescind such deter-
mination after the submission of an abbreviated applica-
tion for such drug under this subsection unless— 
‘‘(I) the formulation of the listed drug has been 
changed and the Secretary has determined that the prior 
listed drug formulation was withdrawn for reasons of safe-
ty or effectiveness; or 
‘‘(II) the Secretary makes a written determination 
that the prior determination must be changed because an 
error has been identified. 
‘‘(iv) If the Secretary makes a written determination 
described in clause (iii)(II), the Secretary shall provide no-
tice and a copy of the written determination to the person 
making the request under clause (i). 
‘‘(v) The disclosures authorized under clauses (i) and 
(ii) are disclosures authorized by law, including for pur-
poses of section 1905 of title 18, United States Code. This 
subparagraph shall not otherwise be construed to author-
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953 
ize the disclosure of nonpublic qualitative or quantitative 
information about the ingredients in a listed drug, or to 
affect the status, if any, of such information as trade se-
cret or confidential commercial information for purposes 
of section 301(j) of this Act, section 552 of title 5, United 
States Code, or section 1905 of title 18, United States 
Code.’’. 
(b) GUIDANCE.— 
(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall issue 
draft guidance, or update guidance, describing how 
the Secretary will determine whether a drug is quali-
tatively and quantitatively the same as the listed 
drug 
(as 
such 
terms 
are 
used 
in 
section 
505(j)(3)(H) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a)), including 
with respect to assessing pH adjusters. 
(2) PROCESS.—In issuing guidance under this 
subsection, the Secretary of Health and Human 
Services shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
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954 
(C) after considering any comments re-
ceived and not later than one year after the 
close of the comment period on the draft guid-
ance, publish final guidance. 
(c) APPLICABILITY.—Section 505(j)(3)(H) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), applies beginning on the date of enactment 
of this Act, irrespective of the date on which the guidance 
required by subsection (b) is finalized. 
Æ 
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