H. R. 7148—518 
(1) in paragraph (1)(A), by inserting ‘‘(including obstetri-
cians and gynecologists)’’ after ‘‘clinical specialties’’; and 
(2) in paragraph (3)(A)(i)— 
(A) in subclause (I), by striking ‘‘as applicable’’ and 
inserting ‘‘if available’’; and 
(B) in subclause (III), by striking ‘‘, as appropriate’’ 
and inserting ‘‘and coordinating with individuals respon-
sible for certifying deaths to improve the collection and 
quality of death record reports, including by amending 
errors and missing or incomplete information to cause- 
of-death information on a death certificate, as appropriate’’. 
(b) MATERNAL MORTALITY.—Section 317K of the Public Health 
Service Act (42 U.S.C. 247b–12) is amended— 
(1) by redesignating subsections (e) and (f) as subsections 
(f) and (g), respectively; and 
(2) by inserting after subsection (d) the following: 
‘‘(e) BEST
PRACTICES
RELATING
TO
THE
PREVENTION
OF 
MATERNAL MORTALITY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall, in consultation with the Administrator of the Health 
Resources and Services Administration, identify and dissemi-
nate to health care providers, relevant professional societies, 
and perinatal quality collaboratives, best practices related to 
preventing maternal morbidity and mortality, taking into 
consideration any relevant findings from other Federal 
maternal health programs. 
‘‘(2) FREQUENCY.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall disseminate the best practices referred to in paragraph 
(1) not less than once per fiscal year.’’. 
(c) AUTHORIZATION OF APPROPRIATIONS.—Subsection (g) of sec-
tion 317K of the Public Health Service Act (42 U.S.C. 247b–12), 
as redesignated by subsection (b)(1), is amended by striking 
‘‘$58,000,000 for each of fiscal years 2019 through 2023’’ and 
inserting ‘‘$100,000,000 for each of fiscal years 2026 through 2030’’. 
SEC. 6502. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK. 
Section 372 of the Public Health Service Act (42 U.S.C. 274) 
is amended— 
(1) in subsection (b)(2)— 
(A) by moving the margins of subparagraphs (M) 
through (O) 2 ems to the left; 
(B) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘, and’’ and inserting 
‘‘; and’’; and 
(ii) in clause (ii), by striking the comma at the 
end and inserting a semicolon; 
(C) in subparagraph (C), by striking ‘‘twenty-four-hour 
telephone service’’ and inserting ‘‘24-hour telephone or 
information technology service’’; 
(D) in each of subparagraphs (B) through (M), by 
striking the comma at the end and inserting a semicolon; 
(E) in subparagraph (N), by striking ‘‘transportation, 
and’’ and inserting ‘‘transportation;’’; 
(F) in subparagraph (O), by striking the period and 
inserting a semicolon; and
H. R. 7148—519 
(G) by adding at the end the following: 
‘‘(P) encourage the integration of electronic health records 
systems through application programming interfaces (or suc-
cessor technologies) among hospitals, organ procurement 
organizations, and transplant centers, including the use of auto-
mated electronic hospital referrals and the grant of remote, 
electronic access to hospital electronic health records of poten-
tial donors by organ procurement organizations, in a manner 
that complies with the privacy regulations promulgated under 
the Health Insurance Portability and Accountability Act of 
1996, at part 160 of title 45, Code of Federal Regulations, 
and subparts A, C, and E of part 164 of such title (or any 
successor regulations); and 
‘‘(Q) consider establishing a dashboard to display the 
number of transplants performed, the types of transplants per-
formed, the number and types of organs that entered the Organ 
Procurement and Transplantation Network system and failed 
to be transplanted, and other appropriate statistics, which 
should be updated more frequently than annually.’’; and 
(2) by adding at the end the following: 
‘‘(d) REGISTRATION FEES.— 
‘‘(1) IN GENERAL.—The Secretary may collect registration 
fees from any member of the Organ Procurement and 
Transplantation Network for each transplant candidate such 
member places on the list described in subsection (b)(2)(A)(i). 
Such registration fees shall be collected and distributed only 
to support the operation of the Organ Procurement and 
Transplantation Network. Such registration fees are authorized 
to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect the registra-
tion fees under paragraph (1) directly or through awards made 
under subsection (b)(1)(A). 
‘‘(3) DISTRIBUTION.—Any amounts collected under this sub-
section shall— 
‘‘(A) be credited to the currently applicable appropria-
tion, account, or fund of the Department of Health and 
Human Services as discretionary offsetting collections; and 
‘‘(B) be available, only to the extent and in the amounts 
provided in advance in appropriations Acts, to distribute 
such fees among awardees described in subsection (b)(1)(A). 
‘‘(4) TRANSPARENCY.—The Secretary shall— 
‘‘(A) promptly post on the website of the Organ Procure-
ment and Transplantation Network— 
‘‘(i) the amount of registration fees collected under 
this subsection from each member of the Organ 
Procurement and Transplantation Network; and 
‘‘(ii) a list of activities such fees are used to sup-
port; and 
‘‘(B) update the information posted pursuant to 
subparagraph (A), as applicable for each calendar quarter 
for which fees are collected under paragraph (1). 
‘‘(5) GAO REVIEW.—Not later than 2 years after the date 
of enactment of this subsection, the Comptroller General of 
the United States shall, to the extent data are available— 
‘‘(A) conduct a review concerning the activities under 
this subsection; and
H. R. 7148—520 
‘‘(B) submit to the Committee on Health, Education, 
Labor, and Pensions and the Committee on Finance of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives, a report on such review, 
including related recommendations, as applicable. 
‘‘(6) SUNSET.—The authority to collect registration fees 
under paragraph (1) shall expire on the date that is 3 years 
after the date of enactment of the Consolidated Appropriations 
Act, 2026.’’. 
SEC. 6503. HONOR OUR LIVING DONORS. 
(a) NO CONSIDERATION
OF INCOME
OF ORGAN RECIPIENT.— 
Section 377 of the Public Health Service Act (42 U.S.C. 274f) 
is amended— 
(1) by redesignating subsections (c) through (f) as sub-
sections (d) through (g), respectively; 
(2) by inserting after subsection (b) the following: 
‘‘(c) NO CONSIDERATION OF INCOME OF ORGAN RECIPIENT.— 
The recipient of a grant under this section, in providing reimburse-
ment to a donating individual through such grant, shall not give 
any consideration to the income of the organ recipient.’’; and 
(3) in subsection (f), as so redesignated— 
(A) in paragraph (1), by striking ‘‘subsection (c)(1)’’ 
and inserting ‘‘subsection (d)(1)’’; and 
(B) in paragraph (2), by striking ‘‘subsection (c)(2)’’ 
and inserting ‘‘subsection (d)(2)’’. 
(b) REMOVAL OF EXPECTATION OF PAYMENTS BY ORGAN RECIPI-
ENTS.—Section 377(e) of the Public Health Service Act (42 U.S.C. 
274f(e)), as redesignated by subsection (a)(1), is amended— 
(1) in paragraph (1), by adding ‘‘or’’ at the end; 
(2) in paragraph (2), by striking ‘‘; or’’ and inserting a 
period; and 
(3) by striking paragraph (3). 
(c) ANNUAL REPORT.—Section 377 of the Public Health Service 
Act (42 U.S.C. 274f), as amended by subsections (a) and (b), is 
amended by adding at the end the following: 
‘‘(h) ANNUAL REPORT.—Not later than December 31 of each 
year, beginning in fiscal year 2027, the Secretary shall— 
‘‘(1) prepare, submit to the Congress, and make public 
a report on whether grants under this section provided ade-
quate funding during the preceding fiscal year to reimburse 
all donating individuals participating in the grant program 
under this section for all qualifying expenses; and 
‘‘(2) include in each such report— 
‘‘(A) the estimated number of all donating individuals 
participating in the grant program under this section who 
did not receive reimbursement for all qualifying expenses 
during the preceding fiscal year; and 
‘‘(B) the total amount of funding that is estimated 
to be necessary to fully reimburse all donating individuals 
participating in the grant program under this section for 
all qualifying expenses.’’. 
SEC. 6504. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 
284m(d)(1)) is amended by striking ‘‘section,’’ and all that follows 
through the period at the end and inserting ‘‘section, $25,000,000 
for each of fiscal years 2026 through 2028.’’.
H. R. 7148—521 
SEC. 6505. SICKLE CELL DISEASE PREVENTION AND TREATMENT. 
(a) IN GENERAL.—Section 1106(b) of the Public Health Service 
Act (42 U.S.C. 300b–5(b)) is amended— 
(1) in paragraph (1)(A)(iii), by striking ‘‘prevention and 
treatment of sickle cell disease’’ and inserting ‘‘treatment of 
sickle cell disease and the prevention and treatment of com-
plications of sickle cell disease’’; 
(2) in paragraph (2)(D), by striking ‘‘prevention and treat-
ment of sickle cell disease’’ and inserting ‘‘treatment of sickle 
cell disease and the prevention and treatment of complications 
of sickle cell disease’’; 
(3) in paragraph (3)— 
(A) in subparagraph (A), by striking ‘‘enter into a con-
tract with’’ and inserting ‘‘make a grant to, or enter into 
a contract or cooperative agreement with,’’; and 
(B) in subparagraph (B), in each of clauses (ii) and 
(iii), by striking ‘‘prevention and treatment of sickle cell 
disease’’ and inserting ‘‘treatment of sickle cell disease 
and the prevention and treatment of complications of sickle 
cell disease’’; and 
(4) in paragraph (6), by striking ‘‘$4,455,000 for each of 
fiscal years 2019 through 2023’’ and inserting ‘‘$8,205,000 for 
each of fiscal years 2026 through 2030’’. 
(b) SENSE
OF CONGRESS.—It is the sense of Congress that 
further research should be undertaken to expand the understanding 
of the causes of, and to find cures for, heritable blood disorders, 
including sickle cell disease. 
SEC. 6506. LIFESPAN RESPITE CARE. 
(a) DEFINITION OF FAMILY CAREGIVER.—Section 2901(5) of the 
Public Health Service Act (42 U.S.C. 300ii(5)) is amended by 
striking ‘‘unpaid adult’’ and inserting ‘‘unpaid individual’’. 
(b) FUNDING.—Section 2905 of the Public Health Service Act 
(42 U.S.C. 300ii–4) is amended by striking ‘‘fiscal years 2020 
through fiscal year 2024’’ and inserting ‘‘fiscal years 2026 through 
2030’’. 
SEC. 6507. PREEMIE. 
(a) RESEARCH RELATING
TO PRETERM LABOR
AND DELIVERY 
AND THE CARE, TREATMENT, AND OUTCOMES OF PRETERM AND LOW 
BIRTHWEIGHT INFANTS.— 
(1) IN GENERAL.—Section 3(e) of the Prematurity Research 
Expansion and Education for Mothers who deliver Infants Early 
Act (42 U.S.C. 247b–4f(e)) is amended by striking ‘‘fiscal years 
2019 through 2023’’ and inserting ‘‘fiscal years 2026 through 
2030’’. 
(2) TECHNICAL
CORRECTION.—Effective as if included in 
the enactment of the PREEMIE Reauthorization Act of 2018 
(Public Law 115–328), section 2 of such Act is amended, in 
the matter preceding paragraph (1), by striking ‘‘Section 2’’ 
and inserting ‘‘Section 3’’. 
(b) INTERAGENCY
WORKING
GROUP.—Section 5(a) of the 
PREEMIE Reauthorization Act of 2018 (Public Law 115–328) is 
amended by striking ‘‘The Secretary of Health and Human Services, 
in collaboration with other departments, as appropriate, may estab-
lish’’ and inserting ‘‘Not later than 18 months after the date of 
the enactment of the Consolidated Appropriations Act, 2026, the
H. R. 7148—522 
Secretary of Health and Human Services, in collaboration with 
other departments, as appropriate, shall establish’’. 
(c) STUDY ON PRETERM BIRTHS.— 
(1) IN
GENERAL.—The Secretary of Health and Human 
Services shall enter into appropriate arrangements with the 
National Academies of Sciences, Engineering, and Medicine 
under which the National Academies shall— 
(A) not later than 30 days after the date of enactment 
of this Act, convene a committee of experts in maternal 
health to study premature births in the United States; 
and 
(B) upon completion of the study under subparagraph 
(A)— 
(i) approve by consensus a report on the results 
of such study; 
(ii) include in such report— 
(I) an assessment of each of the topics listed 
in paragraph (2); 
(II) the analysis required by paragraph (3); 
and 
(III) the raw data used to develop such report; 
and 
(iii) not later than 24 months after the date of 
enactment of this Act, transmit such report to— 
(I) the Secretary of Health and Human Serv-
ices; 
(II) the Committee on Energy and Commerce 
of the House of Representatives; and 
(III) the Committee on Finance and the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate. 
(2) ASSESSMENT
TOPICS.—The topics listed in this sub-
section are each of the following: 
(A) The financial costs of premature birth to society, 
including— 
(i) an analysis of stays in neonatal intensive care 
units and the cost of such stays; 
(ii) long-term costs of stays in such units to society 
and the family involved post-discharge; and 
(iii) health care costs for families post-discharge 
from such units (such as medications, therapeutic serv-
ices, co-payments for visits, and specialty equipment). 
(B) The factors that impact preterm birth rates. 
(C) Opportunities for earlier detection of premature 
birth risk factors, including— 
(i) opportunities to improve maternal and infant 
health; and 
(ii) opportunities for public health programs to 
provide support and resources for parents in-hospital, 
in non-hospital settings, and post-discharge. 
(3) ANALYSIS.—The analysis required by this subsection 
is an analysis of— 
(A) targeted research strategies to develop effective 
drugs, treatments, or interventions to bring at-risk preg-
nancies to term; 
(B) State and other programs’ best practices with 
respect to reducing premature birth rates; and
H. R. 7148—523 
(C) 
precision 
medicine 
and 
preventative 
care 
approaches starting early in the life course (including 
during pregnancy) with a focus on behavioral and biological 
influences on premature birth, child health, and the trajec-
tory of such approaches into adulthood. 
SEC. 6508. DR. LORNA BREEN HEALTH CARE PROVIDER PROTECTION. 
(a) DISSEMINATION OF BEST PRACTICES.—Section 2 of the Dr. 
Lorna Breen Health Care Provider Protection Act (Public Law 117– 
105) is amended by striking ‘‘2 years’’ and inserting ‘‘5 years’’. 
(b) EDUCATION AND AWARENESS INITIATIVE ENCOURAGING USE 
OF MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES BY 
HEALTH CARE PROFESSIONALS.—Section 3 of the Dr. Lorna Breen 
Health Care Provider Protection Act (Public Law 117–105) is 
amended— 
(1) in subsection (b), by inserting ‘‘and annually thereafter,’’ 
after ‘‘of this Act,’’; and 
(2) in subsection (c), by striking ‘‘2022 through 2024’’ and 
inserting ‘‘2026 through 2030’’. 
(c) PROGRAMS
TO PROMOTE MENTAL HEALTH AMONG
THE 
HEALTH PROFESSIONAL WORKFORCE.—The second section 764 of 
the Public Health Service Act (42 U.S.C. 294t), as added by section 
4 of the Dr. Lorna Breen Health Care Provider Protection Act 
(Public Law 117–105), is amended— 
(1) by redesignating such section 764 as section 764A; 
(2) in subsection (a)(3)— 
(A) by striking ‘‘to eligible entities in’’ and inserting 
‘‘to eligible entities that— 
‘‘(A) are in’’; 
(B) by striking the period and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(B) have a focus on the reduction of administrative 
burden on health care workers.’’; 
(3) in subsection (c), by inserting ‘‘not less than’’ after 
‘‘period of’’; and 
(4) in subsection (f), by striking ‘‘2022 through 2024’’ and 
inserting ‘‘2026 through 2030’’. 
TITLE VI—FOOD AND DRUG 
ADMINISTRATION 
Subtitle A—Mikaela Naylon Give Kids a 
Chance Act 
SEC. 6601. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL 
AUTHORITIES OF FOOD AND DRUG ADMINISTRATION 
REGARDING MOLECULARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR APPLICATION DRUG; 
LIMITATION
REGARDING
NOVEL-COMBINATION
APPLICATION 
DRUG.—Section 505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended— 
(A) by redesignating subparagraphs (B) and (C) as 
subparagraphs (C) and (D), respectively; and
H. R. 7148—524 
(B) by striking subparagraph (A) and inserting the 
following: 
‘‘(A) IN GENERAL.—For purposes of paragraph (1)(B), 
the investigation described in this paragraph is a molecu-
larly targeted pediatric cancer investigation of— 
‘‘(i) the drug or biological product for which the 
application referred to in such paragraph is submitted; 
or 
‘‘(ii) such drug or biological product used in com-
bination with— 
‘‘(I) an active ingredient of a drug or biological 
product— 
‘‘(aa) for which an approved application 
under section 505(j) under this Act or under 
section 351(k) of the Public Health Service 
Act is in effect; and 
‘‘(bb) that is determined by the Secretary, 
after consultation with the applicant, to be 
part of the standard of care for treating a 
pediatric cancer; or 
‘‘(II) an active ingredient of a drug or biological 
product— 
‘‘(aa) for which an approved application 
under section 505(b) of this Act or section 
351(a) of the Public Health Service Act to treat 
an adult cancer is in effect and is held by 
the same person submitting the application 
under paragraph (1)(B); and 
‘‘(bb) that is directed at a molecular target 
that the Secretary determines to be substan-
tially relevant to the growth or progression 
of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN OF INVESTIGATION.—A molecularly tar-
geted pediatric cancer investigation referred to in 
subparagraph (A) shall be designed to yield clinically 
meaningful pediatric study data that is gathered using 
appropriate formulations for each age group for which 
the study is required, regarding dosing, safety, and 
preliminary efficacy to inform potential pediatric 
labeling. 
‘‘(ii) LIMITATION.—An investigation described in 
subparagraph (A)(ii) may be required only if the drug 
or biological product for which the application referred 
to in paragraph (1)(B) contains either— 
‘‘(I) a single new active ingredient; or 
‘‘(II) more than one active ingredient, if an 
application for the combination of active ingredi-
ents has not previously been approved but each 
active ingredient is in a drug product that has 
been previously approved to treat an adult cancer. 
‘‘(iii) RESULTS OF ALREADY-COMPLETED PRECLINICAL 
STUDIES OF APPLICATION DRUG.—With respect to an 
investigation required pursuant to paragraph (1)(B), 
the Secretary may require the results of any completed 
preclinical studies relevant to the initial pediatric 
study plan be submitted to the Secretary at the same
H. R. 7148—525 
time that the initial pediatric study plan required 
under subsection (e)(1) is submitted. 
‘‘(iv) RULE OF CONSTRUCTION REGARDING INACTIVE 
INGREDIENTS.—With respect to a combination of active 
ingredients referred to in subparagraph (A)(ii), such 
subparagraph shall not be construed as addressing 
the use of inactive ingredients with such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIREMENTS.—Sec-
tion 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(e)(1)) is amended by adding at the end the 
following: ‘‘The Secretary shall determine whether subpara-
graph (A) or (B) of subsection (a)(1) applies with respect to 
an application before the date on which the applicant is 
required to submit the initial pediatric study plan under para-
graph (2)(A).’’. 
(3) CLARIFYING APPLICABILITY.—Section 505B(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) 
is amended by adding at the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No application that is 
subject to the requirements of subparagraph (B) shall be 
subject to the requirements of subparagraph (A), and no 
application (or supplement to an application) that is subject 
to the requirements of subparagraph (A) shall be subject 
to the requirements of subparagraph (B).’’. 
(4) CONFORMING
AMENDMENTS.—Section 505B(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is 
amended— 
(A) in paragraph (3)(C), as redesignated by paragraph 
(1)(A) of this subsection, by striking ‘‘investigations 
described in this paragraph’’ and inserting ‘‘investigations 
referred to in subparagraph (A)’’; and 
(B) in paragraph (3)(D), as redesignated by paragraph 
(1)(A) of this subsection, by striking ‘‘the assessments under 
paragraph (2)(B)’’ and inserting ‘‘the assessments required 
under paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall— 
(1) not later than 12 months after the date of enactment 
of this Act, issue draft guidance on the implementation of 
the amendments made by subsection (a); and 
(2) not later than 12 months after closing the comment 
period on such draft guidance, finalize such guidance. 
(c) APPLICABILITY.—The amendments made by this section 
apply with respect to any application under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any 
application under section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)), that is submitted on or after the date that 
is 3 years after the date of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERVICES.—Not later 
than 6 years after the date of enactment of this Act, the 
Secretary of Health and Human Services shall submit to the 
Committee on Energy and Commerce of the House of Represent-
atives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the Secretary’s efforts, 
in coordination with industry, to ensure implementation of 
the amendments made by subsection (a).
H. R. 7148—526 
(2) GAO STUDY AND REPORT.— 
(A) STUDY.—Not later than 8 years after the date 
of enactment of this Act, the Comptroller General of the 
United States shall conduct a study of the effectiveness 
of requiring assessments and investigations described in 
section 505B of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C.355c), as amended by subsection (a), in the 
development of drugs and biological products for pediatric 
cancer indications, including consideration of any benefits 
to, or burdens on, pediatric cancer drug development. 
(B) FINDINGS.—Not later than 10 years after the date 
of enactment of this Act, the Comptroller General shall 
submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a 
report containing the findings of the study conducted under 
subparagraph (A). 
SEC. 6602. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIRE-
MENTS. 
(a) EQUAL ACCOUNTABILITY
FOR PEDIATRIC STUDY REQUIRE-
MENTS.—Section 505B(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(d)) is amended— 
(1) in paragraph (1), by striking ‘‘Beginning 270’’ and 
inserting ‘‘NONCOMPLIANCE LETTER.—Beginning 270’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘The drug or’’ and inserting ‘‘EFFECT 
OF NONCOMPLIANCE.—The drug or’’; and 
(B) by striking ‘‘(except that the drug or biological 
product shall not be subject to action under section 303)’’ 
and inserting ‘‘(except that the drug or biological product 
shall be subject to action under section 303 only if such 
person demonstrated a lack of due diligence in satisfying 
the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not issue enforce-
ment actions under section 303 for failures under this sub-
section in the case of a drug or biological product that is 
no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection 
(a), is further amended by adding at the end the following: 
‘‘(4) DUE DILIGENCE.—Before the Secretary may conclude 
that a person failed to submit or otherwise meet a requirement 
as described in the matter preceding paragraph (1), the Sec-
retary shall— 
‘‘(A) issue a noncompliance letter pursuant to para-
graph (1); 
‘‘(B) provide such person with a 45-day period begin-
ning on the date of receipt of such noncompliance letter 
to respond in writing as set forth in such paragraph; and 
‘‘(C) after reviewing such written response, determine 
whether the person demonstrated a lack of due diligence 
in satisfying such requirement.’’. 
(c) CONFORMING AMENDMENTS.—Section 303(f)(4)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is 
amended by striking ‘‘or 505–1’’ and inserting ‘‘505–1, or 505B’’.
H. R. 7148—527 
(d) TRANSITION RULE.—The Secretary of Health and Human 
Services may take enforcement action under section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) only for 
failures described in section 505B(d) of such Act (21 U.S.C. 355c(d)) 
that occur on or after the date that is 180 days after the date 
of enactment of this Act. 
SEC. 6603. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration Safety 
and Innovation Act (21 U.S.C. 355c–1(b)) is amended— 
(1) in paragraph (11), by striking the semicolon at the 
end and inserting ‘‘, including an evaluation of compliance 
with deadlines provided for in deferrals and deferral exten-
sions;’’; 
(2) in paragraph (15), by striking ‘‘and’’ at the end; 
(3) in paragraph (16), by striking the period at the end 
and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or payments under 
section 303 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353) for failure to comply with requirements under 
such section 505B, including, for each penalty, settlement, or 
payment, the name of the drug, the sponsor thereof, and the 
amount of the penalty, settlement, or payment imposed.’’. 
SEC. 6604. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW 
VOUCHERS TO ENCOURAGE TREATMENTS FOR RARE 
PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended 
by striking ‘‘December 20, 2024, unless’’ and all that follows through 
the period at the end and inserting ‘‘September 30, 2029.’’. 
(b) USER FEE PAYMENT.—Section 529(c)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by 
striking subparagraph (A) and inserting the following: 
‘‘(A) IN
GENERAL.—The priority review user fee 
required by this subsection shall be due upon the submis-
sion of a human drug application under section 505(b)(1) 
or section 351(a) of the Public Health Service Act for which 
the priority review voucher is used. All other user fees 
associated with the human drug application shall be due 
as required by the Secretary or under applicable law.’’. 
(c) GAO REPORT ON EFFECTIVENESS OF RARE PEDIATRIC DIS-
EASE PRIORITY VOUCHER AWARDS IN INCENTIVIZING RARE PEDIATRIC 
DISEASE DRUG DEVELOPMENT.— 
(1) GAO STUDY.— 
(A) STUDY.—The Comptroller General of the United 
States shall conduct a study of the effectiveness of awarding 
rare pediatric disease priority vouchers under section 529 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the development 
of human drug products that treat or prevent rare pediatric 
diseases (as defined in such section 529). 
(B) CONTENTS
OF
STUDY.—In conducting the study 
under subparagraph (A), the Comptroller General shall 
examine the following: 
(i) The indications for each drug or biological 
product that—
H. R. 7148—530 
‘‘(1) in consultation with the governments of Abraham 
Accords countries, as well as appropriate United States Govern-
ment diplomatic and security personnel— 
‘‘(A) select the location of the Abraham Accords Office 
in an Abraham Accords country; and 
‘‘(B) establish such office; and 
‘‘(2) assign to such office such personnel of the Food and 
Drug Administration as the Secretary determines necessary 
to carry out the functions of such office. 
‘‘(c) DUTIES.—The Secretary, acting through the Director of 
the Abraham Accords Office, shall— 
‘‘(1) after the Abraham Accords Office is established— 
‘‘(A) as part of the Food and Drug Administration’s 
work to strengthen the international oversight of regulated 
commodities, provide technical assistance to regulatory 
partners in Abraham Accords countries on strengthening 
regulatory oversight and converging regulatory require-
ments for the oversight of regulated products, including 
good manufacturing practices and other issues relevant 
to manufacturing medical products that are regulated by 
the Food and Drug Administration; and 
‘‘(B) facilitate interactions between the Food and Drug 
Administration and interested parties in Abraham Accords 
countries, including by sharing relevant information 
regarding United States regulatory pathways with such 
parties, and facilitate feedback on the research, develop-
ment, and manufacturing of products regulated in accord-
ance with this Act; and 
‘‘(2) carry out other functions and activities as the Secretary 
determines to be necessary to carry out this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In this section, 
the term ‘Abraham Accords country’ means a country identified 
by the Department of State as having signed the Abraham Accords 
Declaration. 
‘‘(e) NATIONAL SECURITY.—Nothing in this section shall be con-
strued to require any action inconsistent with a national security 
recommendation provided by the Federal Government.’’. 
(b) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall submit to the Congress a report on the Abraham 
Accords Office, including— 
(A) an evaluation of how the Office has advanced 
progress toward conformance with Food and Drug Adminis-
tration regulatory requirements by manufacturers in the 
Abraham Accords countries; 
(B) a numerical count of parties that the Office has 
helped facilitate interactions or feedback pursuant to sec-
tion 1015(c)(1)(B) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)); 
(C) a summary of technical assistance provided to regu-
latory partners in Abraham Accords countries pursuant 
to subparagraph (A) of such section 1015(c)(1); and 
(D) recommendations for increasing and improving 
coordination between the Food and Drug Administration 
and entities in Abraham Accords countries.
H. R. 7148—531 
(2) ABRAHAM
ACCORDS
COUNTRY
DEFINED.—In this sub-
section, the term ‘‘Abraham Accords country’’ has the meaning 
given such term in section 1015(d) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)). 
TITLE VII—LOWERING PRESCRIPTION 
DRUG COSTS 
SEC. 6701. OVERSIGHT OF PHARMACY BENEFIT MANAGEMENT SERV-
ICES. 
(a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of the Public 
Health Service Act (42 U.S.C. 300gg et seq.) is amended— 
(1) in part D (42 U.S.C. 300gg–111 et seq.), by adding 
at the end the following new section: 
‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY 
BENEFIT MANAGEMENT SERVICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or after the 
date that is 30 months after the date of enactment of this section 
(referred to in this subsection and subsection (b) as the ‘effective 
date’), a group health plan or a health insurance issuer offering 
group health insurance coverage, or an entity providing pharmacy 
benefit management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or renewal 
of a contract, entered into on or after the effective date, with 
an applicable entity unless such applicable entity agrees to— 
‘‘(1) not limit or delay the disclosure of information to 
the group health plan (including such a plan offered through 
a health insurance issuer) in such a manner that prevents 
an entity providing pharmacy benefit management services on 
behalf of a group health plan or health insurance issuer offering 
group health insurance coverage from making the reports 
described in subsection (b); and 
‘‘(2) provide the entity providing pharmacy benefit manage-
ment services on behalf of a group health plan or health insur-
ance issuer relevant information necessary to make the reports 
described in subsection (b). 
‘‘(b) REPORTS.— 
‘‘(1) IN GENERAL.—For plan years beginning on or after 
the effective date, in the case of any contract between a group 
health plan or a health insurance issuer offering group health 
insurance coverage offered in connection with such a plan and 
an entity providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension or renewal 
of such a contract, entered into on or after the effective date, 
the entity providing pharmacy benefit management services 
on behalf of such a group health plan or health insurance 
issuer, not less frequently than every 6 months (or, at the 
request of a group health plan, not less frequently than quar-
terly, and under the same conditions, terms, and cost of the 
semiannual report under this subsection), shall submit to the 
group health plan a report in accordance with this section. 
Each such report shall be made available to such group health 
plan in plain language, in a machine-readable format, and 
as the Secretary may determine, other formats. Each such
H. R. 7148—532 
report shall include the information described in paragraph 
(2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes of paragraph 
(1), the information described in this paragraph is, with respect 
to drugs covered by a group health plan or group health insur-
ance coverage offered by a health insurance issuer in connection 
with a group health plan during each reporting period— 
‘‘(A) in the case of a group health plan that is offered 
by a specified large employer or that is a specified large 
plan, and is not offered as health insurance coverage, or 
in the case of health insurance coverage for which the 
election under paragraph (3) is made for the applicable 
reporting period— 
‘‘(i) a list of drugs for which a claim was filed 
and, with respect to each such drug on such list— 
‘‘(I) the contracted compensation paid by the 
group health plan or health insurance issuer for 
each covered drug (identified by the National Drug 
Code) to the entity providing pharmacy benefit 
management services or other applicable entity 
on behalf of the group health plan or health insur-
ance issuer; 
‘‘(II) the contracted compensation paid to the 
pharmacy, by any entity providing pharmacy ben-
efit management services or other applicable entity 
on behalf of the group health plan or health insur-
ance issuer, for each covered drug (identified by 
the National Drug Code); 
‘‘(III) for each such claim, the difference 
between the amount paid under subclause (I) and 
the amount paid under subclause (II); 
‘‘(IV) the proprietary name, established name 
or proper name, and the National Drug Code; 
‘‘(V) for each claim for the drug (including 
original prescriptions and refills) and for each dos-
age unit of the drug for which a claim was filed, 
the type of dispensing channel used to furnish 
the drug, including retail, mail order, or specialty 
pharmacy; 
‘‘(VI) with respect to each drug dispensed, for 
each type of dispensing channel (including retail, 
mail order, or specialty pharmacy)— 
‘‘(aa) whether such drug is a brand name 
drug or a generic drug, and— 
‘‘(AA) in the case of a brand name 
drug, the wholesale acquisition cost, listed 
as cost per days supply and cost per dos-
age unit, on the date such drug was dis-
pensed; and 
‘‘(BB) in the case of a generic drug, 
the average wholesale price, listed as cost 
per days supply and cost per dosage unit, 
on the date such drug was dispensed; and 
‘‘(bb) the total number of— 
‘‘(AA) prescription claims (including 
original prescriptions and refills);
H. R. 7148—533 
‘‘(BB) participants and beneficiaries 
for whom a claim for such drug was filed 
through 
the 
applicable 
dispensing 
channel; 
‘‘(CC) dosage units and dosage units 
per fill of such drug; and 
‘‘(DD) days supply of such drug per 
fill; 
‘‘(VII) the net price per course of treatment 
or single fill, such as a 30-day supply or 90-day 
supply to the plan or coverage after rebates, fees, 
alternative discounts, or other remuneration 
received from applicable entities; 
‘‘(VIII) the total amount of out-of-pocket 
spending by participants and beneficiaries on such 
drug, including spending through copayments, 
coinsurance, and deductibles, but not including any 
amounts spent by participants and beneficiaries 
on drugs not covered under the plan or coverage, 
or for which no claim is submitted under the plan 
or coverage; 
‘‘(IX) the total net spending on the drug; 
‘‘(X) the total amount received, or expected 
to be received, by the plan or issuer from any 
applicable entity in rebates, fees, alternative dis-
counts, or other remuneration; 
‘‘(XI) the total amount received, or expected 
to be received, by the entity providing pharmacy 
benefit management services, from applicable enti-
ties, in rebates, fees, alternative discounts, or other 
remuneration from such entities— 
‘‘(aa) for claims incurred during the 
reporting period; and 
‘‘(bb) that is related to utilization of such 
drug or spending on such drug; and 
‘‘(XII) to the extent feasible, information on 
the total amount of remuneration for such drug, 
including copayment assistance dollars paid, 
copayment cards applied, or other discounts pro-
vided by each drug manufacturer (or entity admin-
istering copayment assistance on behalf of such 
drug manufacturer), to the participants and bene-
ficiaries enrolled in such plan or coverage; 
‘‘(ii) a list of each therapeutic class (as defined 
by the Secretary) for which a claim was filed under 
the group health plan or health insurance coverage 
during the reporting period, and, with respect to each 
such therapeutic class— 
‘‘(I) the total gross spending on drugs in such 
class before rebates, price concessions, alternative 
discounts, or other remuneration from applicable 
entities; 
‘‘(II) the net spending in such class after such 
rebates, price concessions, alternative discounts, 
or other remuneration from applicable entities; 
‘‘(III) the total amount received, or expected 
to be received, by the entity providing pharmacy
H. R. 7148—534 
benefit management services, from applicable enti-
ties, in rebates, fees, alternative discounts, or other 
remuneration from such entities— 
‘‘(aa) for claims incurred during the 
reporting period; and 
‘‘(bb) that is related to utilization of drugs 
or drug spending; 
‘‘(IV) the average net spending per 30-day 
supply and per 90-day supply by the plan or by 
the issuer with respect to such coverage and its 
participants and beneficiaries, among all drugs 
within the therapeutic class for which a claim 
was filed during the reporting period; 
‘‘(V) the number of participants and bene-
ficiaries who filled a prescription for a drug in 
such class, including the National Drug Code for 
each such drug; 
‘‘(VI) if applicable, a description of the for-
mulary tiers and utilization mechanisms (such as 
prior authorization or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket spending under 
the plan or coverage by participants and bene-
ficiaries, including spending through copayments, 
coinsurance, and deductibles, but not including any 
amounts spent by participants and beneficiaries 
on drugs not covered under the plan or coverage 
or for which no claim is submitted under the plan 
or coverage; 
‘‘(iii) with respect to any drug for which gross 
spending under the group health plan or health insur-
ance coverage exceeded $10,000 during the reporting 
period or, in the case that gross spending under the 
group health plan or coverage exceeded $10,000 during 
the reporting period with respect to fewer than 50 
drugs, with respect to the 50 prescription drugs with 
the highest spending during the reporting period— 
‘‘(I) a list of all other drugs in the same thera-
peutic class as such drug; 
‘‘(II) if applicable, the rationale for the for-
mulary placement of such drug in that therapeutic 
category or class, selected from a list of standard 
rationales established by the Secretary, in con-
sultation with stakeholders; and 
‘‘(III) any change in formulary placement com-
pared to the prior plan year; and 
‘‘(iv) in the case that such plan or issuer (or an 
entity providing pharmacy benefit management serv-
ices on behalf of such plan or issuer) has an affiliated 
pharmacy or pharmacy under common ownership, 
including mandatory mail and specialty home delivery 
programs, retail and mail auto-refill programs, and 
cost sharing assistance incentives funded by an entity 
providing pharmacy benefit services— 
‘‘(I) an explanation of any benefit design 
parameters that encourage or require participants 
and beneficiaries in the plan or coverage to fill
H. R. 7148—536 
‘‘(I) contains such information described in 
clauses (iii), (iv), (v), and (vi), as applicable, as 
specified by the Secretary through guidance, pro-
gram instruction, or otherwise (with no require-
ment of notice and comment rulemaking) that the 
Secretary determines useful to participants or 
beneficiaries in better understanding the plan or 
coverage or benefits under such plan or coverage; 
‘‘(II) contains only aggregate information; and 
‘‘(III) states that participants and beneficiaries 
may request specific, claims-level information 
required to be furnished under subsection (c) from 
the group health plan or health insurance issuer; 
and 
‘‘(iii) with respect to drugs covered by such plan 
or coverage during such reporting period— 
‘‘(I) the total net spending by the plan or cov-
erage for all such drugs; 
‘‘(II) the total amount received, or expected 
to be received, by the plan or issuer from any 
applicable entity in rebates, fees, alternative dis-
counts, or other remuneration; and 
‘‘(III) to the extent feasible, information on 
the total amount of remuneration for such drugs, 
including copayment assistance dollars paid, 
copayment cards applied, or other discounts pro-
vided by each drug manufacturer (or entity admin-
istering copayment assistance on behalf of such 
drug manufacturer) to participants and bene-
ficiaries; 
‘‘(iv) amounts paid directly or indirectly in rebates, 
fees, or any other type of compensation (as defined 
in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee 
Retirement Income Security Act) to brokerage firms, 
brokers, consultants, advisors, or any other individual 
or firm, for— 
‘‘(I) the referral of the group health plan’s 
or health insurance issuer’s business to an entity 
providing pharmacy benefit management services, 
including the identity of the recipient of such 
amounts; 
‘‘(II) consideration of the entity providing phar-
macy benefit management services by the group 
health plan or health insurance issuer; or 
‘‘(III) the retention of the entity by the group 
health plan or health insurance issuer; 
‘‘(v) an explanation of any benefit design param-
eters that encourage or require participants and bene-
ficiaries in such plan or coverage to fill prescriptions 
at mail order, specialty, or retail pharmacies that are 
affiliated with or under common ownership with the 
entity providing pharmacy benefit management serv-
ices under such plan or coverage, including mandatory 
mail and specialty home delivery programs, retail and 
mail auto-refill programs, and cost-sharing assistance 
incentives directly or indirectly funded by such entity; 
and
H. R. 7148—537 
‘‘(vi) total gross spending on all drugs under the 
plan or coverage during the reporting period. 
‘‘(3) OPT-IN
FOR
GROUP
HEALTH
INSURANCE
COVERAGE 
OFFERED BY A SPECIFIED LARGE EMPLOYER OR THAT IS A SPECI-
FIED LARGE PLAN.—In the case of group health insurance cov-
erage offered in connection with a group health plan that 
is offered by a specified large employer or is a specified large 
plan, such group health plan may, on an annual basis, for 
plan years beginning on or after the date that is 30 months 
after the date of enactment of this section, elect to require 
an entity providing pharmacy benefit management services on 
behalf of the health insurance issuer to submit to such group 
health plan a report that includes all of the information 
described in paragraph (2)(A), in addition to the information 
described in paragraph (2)(B). 
‘‘(4) PRIVACY REQUIREMENTS.— 
‘‘(A) IN GENERAL.—An entity providing pharmacy ben-
efit management services on behalf of a group health plan 
or a health insurance issuer offering group health insurance 
coverage shall report information under paragraph (1) in 
a manner consistent with the privacy regulations promul-
gated under section 13402(a) of the Health Information 
Technology for Economic and Clinical Health Act and con-
sistent with the privacy regulations promulgated under 
the Health Insurance Portability and Accountability Act 
of 1996 in part 160 and subparts A and E of part 164 
of title 45, Code of Federal Regulations (or successor regula-
tions) (referred to in this paragraph as the ‘HIPAA privacy 
regulations’) and shall restrict the use and disclosure of 
such information according to such privacy regulations and 
such HIPAA privacy regulations. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) IN GENERAL.—An entity providing pharmacy 
benefit management services on behalf of a group 
health plan or health insurance issuer offering group 
health insurance coverage that submits a report under 
paragraph (1) shall ensure that such report contains 
only summary health information, as defined in section 
164.504(a) of title 45, Code of Federal Regulations (or 
successor regulations). 
‘‘(ii) RESTRICTIONS.—In carrying out this sub-
section, a group health plan shall comply with section 
164.504(f) of title 45, Code of Federal Regulations (or 
a successor regulation), and a plan sponsor shall act 
in accordance with the terms of the agreement 
described in such section. 
‘‘(C) RULE OF CONSTRUCTION.— 
‘‘(i) Nothing in this section shall be construed to 
modify the requirements for the creation, receipt, 
maintenance, or transmission of protected health 
information under the HIPAA privacy regulations. 
‘‘(ii) Nothing in this section shall be construed 
to affect the application of any Federal or State privacy 
or civil rights law, including the HIPAA privacy regula-
tions, the Genetic Information Nondiscrimination Act
H. R. 7148—538 
of 2008 (Public Law 110–233) (including the amend-
ments made by such Act), the Americans with Disabil-
ities Act of 1990 (42 U.S.C. 12101 et seq.), section 
504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), 
section 1557 of the Patient Protection and Affordable 
Care Act (42 U.S.C. 18116), title VI of the Civil Rights 
Act of 1964 (42 U.S.C. 2000d), and title VII of the 
Civil Rights Act of 1964 (42 U.S.C. 2000e). 
‘‘(D) WRITTEN NOTICE.—Each plan year, group health 
plans, including with respect to group health insurance 
coverage offered in connection with a group health plan, 
shall provide to each participant or beneficiary written 
notice informing the participant or beneficiary of the 
requirement for entities providing pharmacy benefit 
management services on behalf of the group health plan 
or health insurance issuer offering group health insurance 
coverage to submit reports to group health plans under 
paragraph (1), as applicable, which may include incor-
porating such notification in plan documents provided to 
the participant or beneficiary, or providing individual 
notification. 
‘‘(E) LIMITATION
TO
BUSINESS
ASSOCIATES.—A group 
health plan receiving a report under paragraph (1) may 
disclose such information only to the entity from which 
the report was received or to that entity’s business associ-
ates as defined in section 160.103 of title 45, Code of 
Federal Regulations (or successor regulations) or as per-
mitted by the HIPAA privacy regulations. 
‘‘(F) CLARIFICATION REGARDING PUBLIC DISCLOSURE OF 
INFORMATION.—Nothing in this section shall prevent an 
entity providing pharmacy benefit management services 
on behalf of a group health plan or health insurance issuer 
offering group health insurance coverage, from placing 
reasonable restrictions on the public disclosure of the 
information contained in a report described in paragraph 
(1), except that such plan, issuer, or entity may not— 
‘‘(i) restrict disclosure of such report to the Depart-
ment of Health and Human Services, the Department 
of Labor, or the Department of the Treasury; or 
‘‘(ii) prevent disclosure for the purposes of sub-
section (c), or any other public disclosure requirement 
under this section. 
‘‘(G) LIMITED FORM OF REPORT.—The Secretary shall 
define through rulemaking a limited form of the report 
under paragraph (1) required with respect to any group 
health plan established by a plan sponsor that is, or is 
affiliated with, a drug manufacturer, drug wholesaler, or 
other direct participant in the drug supply chain, in order 
to prevent anti-competitive behavior. 
‘‘(5) STANDARD FORMAT AND REGULATIONS.— 
‘‘(A) IN GENERAL.—Not later than 18 months after the 
date of enactment of this section, the Secretary shall specify 
through rulemaking a standard format for entities pro-
viding pharmacy benefit management services on behalf 
of group health plans and health insurance issuers offering 
group health insurance coverage, to submit reports required 
under paragraph (1).
H. R. 7148—539 
‘‘(B) ADDITIONAL
REGULATIONS.—Not later than 18 
months after the date of enactment of this section, the 
Secretary shall, through rulemaking, promulgate any other 
final regulations necessary to implement the requirements 
of this section. In promulgating such regulations, the Sec-
retary shall, to the extent practicable, align the reporting 
requirements under this section with the reporting require-
ments under section 2799A–10. 
‘‘(c) REQUIREMENT TO PROVIDE INFORMATION TO PARTICIPANTS 
OR BENEFICIARIES.—A group health plan, including with respect 
to group health insurance coverage offered in connection with a 
group health plan, upon request of a participant or beneficiary, 
shall provide to such participant or beneficiary— 
‘‘(1) the summary document described in subsection 
(b)(2)(B)(ii); and 
‘‘(2) the information described in subsection (b)(2)(A)(i)(III) 
with respect to a claim made by or on behalf of such participant 
or beneficiary. 
‘‘(d) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall enforce this section. 
The enforcement authority under this subsection shall apply 
only with respect to group health plans (including group health 
insurance coverage offered in connection with such a plan) 
to which the requirements of subparts I and II of part A 
and part D apply in accordance with section 2722, and with 
respect to entities providing pharmacy benefit management 
services on behalf of such plans and applicable entities pro-
viding services on behalf of such plans. 
‘‘(2) FAILURE TO PROVIDE INFORMATION.—A group health 
plan, a health insurance issuer offering group health insurance 
coverage, an entity providing pharmacy benefit management 
services on behalf of such a plan or issuer, or an applicable 
entity providing services on behalf of such a plan or issuer 
that violates subsection (a); an entity providing pharmacy ben-
efit management services on behalf of such a plan or issuer 
that fails to provide the information required under subsection 
(b); or a group health plan that fails to provide the information 
required under subsection (c), shall be subject to a civil mone-
tary penalty in the amount of $10,000 for each day during 
which such violation continues or such information is not dis-
closed or reported. 
‘‘(3) FALSE INFORMATION.—A health insurance issuer, an 
entity providing pharmacy benefit management services, or 
a third party administrator providing services on behalf of 
such issuer offered by a health insurance issuer that knowingly 
provides false information under this section shall be subject 
to a civil monetary penalty in an amount not to exceed $100,000 
for each item of false information. Such civil monetary penalty 
shall be in addition to other penalties as may be prescribed 
by law. 
‘‘(4) PROCEDURE.—The provisions of section 1128A of the 
Social Security Act, other than subsections (a) and (b) and 
the first sentence of subsection (c)(1) of such section shall 
apply to civil monetary penalties under this subsection in the 
same manner as such provisions apply to a penalty or pro-
ceeding under such section.
H. R. 7148—540 
‘‘(5) WAIVERS.—The Secretary may waive penalties under 
paragraph (2), or extend the period of time for compliance 
with a requirement of this section, for an entity in violation 
of this section that has made a good-faith effort to comply 
with the requirements in this section. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to permit a health insurance issuer, group health 
plan, entity providing pharmacy benefit management services on 
behalf of a group health plan or health insurance issuer, or other 
entity to restrict disclosure to, or otherwise limit the access of, 
the Secretary to a report described in subsection (b)(1) or informa-
tion related to compliance with subsections (a), (b), (c), or (d) by 
such issuer, plan, or entity. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
ENTITY.—The term ‘applicable entity’ 
means— 
‘‘(A) an applicable group purchasing organization, drug 
manufacturer, distributor, wholesaler, rebate aggregator (or 
other purchasing entity designed to aggregate rebates), 
or associated third party; 
‘‘(B) any subsidiary, parent, affiliate, or subcontractor 
of a group health plan, health insurance issuer, entity 
that provides pharmacy benefit management services on 
behalf of such a plan or issuer, or any entity described 
in subparagraph (A); or 
‘‘(C) such other entity as the Secretary may specify 
through rulemaking. 
‘‘(2) APPLICABLE GROUP PURCHASING ORGANIZATION.—The 
term ‘applicable group purchasing organization’ means a group 
purchasing organization that is affiliated with or under common 
ownership with an entity providing pharmacy benefit manage-
ment services. 
‘‘(3) CONTRACTED
COMPENSATION.—The term ‘contracted 
compensation’ means the sum of any ingredient cost and dis-
pensing fee for a drug (inclusive of the out-of-pocket costs 
to the participant or beneficiary), or another analogous com-
pensation structure that the Secretary may specify through 
regulations. 
‘‘(4) GROSS
SPENDING.—The term ‘gross spending’, with 
respect to prescription drug benefits under a group health 
plan or health insurance coverage, means the amount spent 
by a group health plan or health insurance issuer on prescrip-
tion drug benefits, calculated before the application of rebates, 
fees, alternative discounts, or other remuneration. 
‘‘(5) NET SPENDING.—The term ‘net spending’, with respect 
to prescription drug benefits under a group health plan or 
health insurance coverage, means the amount spent by a group 
health plan or health insurance issuer on prescription drug 
benefits, calculated 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. 
‘‘(7) REMUNERATION.—The term ‘remuneration’ has the 
meaning given such term by the Secretary through rulemaking, 
which shall be reevaluated by the Secretary every 5 years.
H. R. 7148—541 
‘‘(8) SPECIFIED LARGE EMPLOYER.—The term ‘specified large 
employer’ means, in connection with a group health plan 
(including group health insurance coverage offered in connec-
tion with such a plan) established or maintained by a single 
employer, with respect to a calendar year or a plan year, 
as applicable, an employer who employed an average of at 
least 100 employees on business 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 ‘specified large plan’ 
means a group health plan (including group health insurance 
coverage offered in connection with such a plan) established 
or maintained by a plan sponsor described in clause (ii) or 
(iii) of section 3(16)(B) of the Employee Retirement Income 
Security Act of 1974 that had an average of at least 100 
participants on business days during the preceding 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.’’; and 
(2) in section 2723 (42 U.S.C. 300gg–22)— 
(A) in subsection (a)— 
(i) in paragraph (1), by inserting ‘‘(other than sec-
tion 2799A–11)’’ after ‘‘part D’’; and 
(ii) in paragraph (2), by inserting ‘‘(other than 
section 2799A–11)’’ after ‘‘part D’’; and 
(B) in subsection (b)— 
(i) in paragraph (1), by inserting ‘‘(other than sec-
tion 2799A–11)’’ after ‘‘part D’’; 
(ii) in paragraph (2)(A), by inserting ‘‘(other than 
section 2799A–11)’’ after ‘‘part D’’; and 
(iii) in paragraph (2)(C)(ii), by inserting ‘‘(other 
than section 2799A–11)’’ after ‘‘part D’’. 
(b) EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.— 
(1) IN
GENERAL.—Subtitle B of title I of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1021 et 
seq.) is amended— 
(A) in subpart B of part 7 (29 U.S.C. 1185 et seq.), 
by adding at the end the following: 
‘‘SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BEN-
EFIT MANAGEMENT SERVICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or after the 
date that is 30 months after the date of enactment of this section 
(referred to in this subsection and subsection (b) as the ‘effective 
date’), a group health plan or a health insurance issuer offering 
group health insurance coverage, or an entity providing pharmacy 
benefit management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or renewal 
of a contract, entered into on or after the effective date, with 
an applicable entity unless such applicable entity agrees to— 
‘‘(1) not limit or delay the disclosure of information to 
the group health plan (including such a plan offered through 
a health insurance issuer) in such a manner that prevents 
an entity providing pharmacy benefit management services on 
behalf of a group health plan or health insurance issuer offering
H. R. 7148—542 
group health insurance coverage from making the reports 
described in subsection (b); and 
‘‘(2) provide the entity providing pharmacy benefit manage-
ment services on behalf of a group health plan or health insur-
ance issuer relevant information necessary to make the reports 
described in subsection (b). 
‘‘(b) REPORTS.— 
‘‘(1) IN GENERAL.—For plan years beginning on or after 
the effective date, in the case of any contract between a group 
health plan or a health insurance issuer offering group health 
insurance coverage offered in connection with such a plan and 
an entity providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension or renewal 
of such a contract, entered into on or after the effective date, 
the entity providing pharmacy benefit management services 
on behalf of such a group health plan or health insurance 
issuer, not less frequently than every 6 months (or, at the 
request of a group health plan, not less frequently than quar-
terly, and under the same conditions, terms, and cost of the 
semiannual report under this subsection), shall submit to the 
group health plan a report in accordance with this section. 
Each such report shall be made available to such group health 
plan in plain language, in a machine-readable format, and 
as the Secretary may determine, other formats. Each such 
report shall include the information described in paragraph 
(2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes of paragraph 
(1), the information described in this paragraph is, with respect 
to drugs covered by a group health plan or group health insur-
ance coverage offered by a health insurance issuer in connection 
with a group health plan during each reporting period— 
‘‘(A) in the case of a group health plan that is offered 
by a specified large employer or that is a specified large 
plan, and is not offered as health insurance coverage, or 
in the case of health insurance coverage for which the 
election under paragraph (3) is made for the applicable 
reporting period— 
‘‘(i) a list of drugs for which a claim was filed 
and, with respect to each such drug on such list— 
‘‘(I) the contracted compensation paid by the 
group health plan or health insurance issuer for 
each covered drug (identified by the National Drug 
Code) to the entity providing pharmacy benefit 
management services or other applicable entity 
on behalf of the group health plan or health insur-
ance issuer; 
‘‘(II) the contracted compensation paid to the 
pharmacy, by any entity providing pharmacy ben-
efit management services or other applicable entity 
on behalf of the group health plan or health insur-
ance issuer, for each covered drug (identified by 
the National Drug Code); 
‘‘(III) for each such claim, the difference 
between the amount paid under subclause (I) and 
the amount paid under subclause (II); 
‘‘(IV) the proprietary name, established name 
or proper name, and the National Drug Code;
H. R. 7148—543 
‘‘(V) for each claim for the drug (including 
original prescriptions and refills) and for each dos-
age unit of the drug for which a claim was filed, 
the type of dispensing channel used to furnish 
the drug, including retail, mail order, or specialty 
pharmacy; 
‘‘(VI) with respect to each drug dispensed, for 
each type of dispensing channel (including retail, 
mail order, or specialty pharmacy)— 
‘‘(aa) whether such drug is a brand name 
drug or a generic drug, and— 
‘‘(AA) in the case of a brand name 
drug, the wholesale acquisition cost, listed 
as cost per days supply and cost per dos-
age unit, on the date such drug was dis-
pensed; and 
‘‘(BB) in the case of a generic drug, 
the average wholesale price, listed as cost 
per days supply and cost per dosage unit, 
on the date such drug was dispensed; and 
‘‘(bb) the total number of— 
‘‘(AA) prescription claims (including 
original prescriptions and refills); 
‘‘(BB) participants and beneficiaries 
for whom a claim for such drug was filed 
through 
the 
applicable 
dispensing 
channel; 
‘‘(CC) dosage units and dosage units 
per fill of such drug; and 
‘‘(DD) days supply of such drug per 
fill; 
‘‘(VII) the net price per course of treatment 
or single fill, such as a 30-day supply or 90-day 
supply to the plan or coverage after rebates, fees, 
alternative discounts, or other remuneration 
received from applicable entities; 
‘‘(VIII) the total amount of out-of-pocket 
spending by participants and beneficiaries on such 
drug, including spending through copayments, 
coinsurance, and deductibles, but not including any 
amounts spent by participants and beneficiaries 
on drugs not covered under the plan or coverage, 
or for which no claim is submitted under the plan 
or coverage; 
‘‘(IX) the total net spending on the drug; 
‘‘(X) the total amount received, or expected 
to be received, by the plan or issuer from any 
applicable entity in rebates, fees, alternative dis-
counts, or other remuneration; 
‘‘(XI) the total amount received, or expected 
to be received, by the entity providing pharmacy 
benefit management services, from applicable enti-
ties, in rebates, fees, alternative discounts, or other 
remuneration from such entities— 
‘‘(aa) for claims incurred during the 
reporting period; and
H. R. 7148—544 
‘‘(bb) that is related to utilization of such 
drug or spending on such drug; and 
‘‘(XII) to the extent feasible, information on 
the total amount of remuneration for such drug, 
including copayment assistance dollars paid, 
copayment cards applied, or other discounts pro-
vided by each drug manufacturer (or entity admin-
istering copayment assistance on behalf of such 
drug manufacturer), to the participants and bene-
ficiaries enrolled in such plan or coverage; 
‘‘(ii) a list of each therapeutic class (as defined 
by the Secretary) for which a claim was filed under 
the group health plan or health insurance coverage 
during the reporting period, and, with respect to each 
such therapeutic class— 
‘‘(I) the total gross spending on drugs in such 
class before rebates, price concessions, alternative 
discounts, or other remuneration from applicable 
entities; 
‘‘(II) the net spending in such class after such 
rebates, price concessions, alternative discounts, 
or other remuneration from applicable entities; 
‘‘(III) the total amount received, or expected 
to be received, by the entity providing pharmacy 
benefit management services, from applicable enti-
ties, in rebates, fees, alternative discounts, or other 
remuneration from such entities— 
‘‘(aa) for claims incurred during the 
reporting period; and 
‘‘(bb) that is related to utilization of drugs 
or drug spending; 
‘‘(IV) the average net spending per 30-day 
supply and per 90-day supply by the plan or by 
the issuer with respect to such coverage and its 
participants and beneficiaries, among all drugs 
within the therapeutic class for which a claim 
was filed during the reporting period; 
‘‘(V) the number of participants and bene-
ficiaries who filled a prescription for a drug in 
such class, including the National Drug Code for 
each such drug; 
‘‘(VI) if applicable, a description of the for-
mulary tiers and utilization mechanisms (such as 
prior authorization or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket spending under 
the plan or coverage by participants and bene-
ficiaries, including spending through copayments, 
coinsurance, and deductibles, but not including any 
amounts spent by participants and beneficiaries 
on drugs not covered under the plan or coverage 
or for which no claim is submitted under the plan 
or coverage; 
‘‘(iii) with respect to any drug for which gross 
spending under the group health plan or health insur-
ance coverage exceeded $10,000 during the reporting 
period or, in the case that gross spending under the
H. R. 7148—545 
group health plan or coverage exceeded $10,000 during 
the reporting period with respect to fewer than 50 
drugs, with respect to the 50 prescription drugs with 
the highest spending during the reporting period— 
‘‘(I) a list of all other drugs in the same thera-
peutic class as such drug; 
‘‘(II) if applicable, the rationale for the for-
mulary placement of such drug in that therapeutic 
category or class, selected from a list of standard 
rationales established by the Secretary, in con-
sultation with stakeholders; and 
‘‘(III) any change in formulary placement com-
pared to the prior plan year; and 
‘‘(iv) in the case that such plan or issuer (or an 
entity providing pharmacy benefit management serv-
ices on behalf of such plan or issuer) has an affiliated 
pharmacy or pharmacy under common ownership, 
including mandatory mail and specialty home delivery 
programs, retail and mail auto-refill programs, and 
cost sharing assistance incentives funded by an entity 
providing pharmacy benefit services— 
‘‘(I) an explanation of any benefit design 
parameters that encourage or require participants 
and beneficiaries in the plan or coverage to fill 
prescriptions at mail order, specialty, or retail 
pharmacies; 
‘‘(II) the percentage of total prescriptions dis-
pensed by such pharmacies to participants or bene-
ficiaries in such plan or coverage; and 
‘‘(III) a list of all drugs dispensed by such 
pharmacies to participants or beneficiaries enrolled 
in such plan or coverage, and, with respect to 
each drug dispensed— 
‘‘(aa) the amount charged, per dosage unit, 
per 30-day supply, or per 90-day supply (as 
applicable) to the plan or issuer, and to partici-
pants and beneficiaries; 
‘‘(bb) the median amount charged to such 
plan or issuer, and the interquartile range 
of the costs, per dosage unit, per 30-day 
supply, and per 90-day supply, including 
amounts paid by the participants and bene-
ficiaries, when the same drug is dispensed 
by other pharmacies that are not affiliated 
with or under common ownership with the 
entity and that are included in the pharmacy 
network of such plan or coverage; 
‘‘(cc) the lowest cost per dosage unit, per 
30-day supply and per 90-day supply, for each 
such drug, including amounts charged to the 
plan or coverage and to participants and bene-
ficiaries, that is available from any pharmacy 
included in the network of such plan or cov-
erage; and 
‘‘(dd) the net acquisition cost per dosage 
unit, per 30-day supply, and per 90-day
H. R. 7148—547 
in section 408(b)(2)(B)(ii)(dd)(AA)) to brokerage firms, 
brokers, consultants, advisors, or any other individual 
or firm, for— 
‘‘(I) the referral of the group health plan’s 
or health insurance issuer’s business to an entity 
providing pharmacy benefit management services, 
including the identity of the recipient of such 
amounts; 
‘‘(II) consideration of the entity providing phar-
macy benefit management services by the group 
health plan or health insurance issuer; or 
‘‘(III) the retention of the entity by the group 
health plan or health insurance issuer; 
‘‘(v) an explanation of any benefit design param-
eters that encourage or require participants and bene-
ficiaries in such plan or coverage to fill prescriptions 
at mail order, specialty, or retail pharmacies that are 
affiliated with or under common ownership with the 
entity providing pharmacy benefit management serv-
ices under such plan or coverage, including mandatory 
mail and specialty home delivery programs, retail and 
mail auto-refill programs, and cost-sharing assistance 
incentives directly or indirectly funded by such entity; 
and 
‘‘(vi) total gross spending on all drugs under the 
plan or coverage during the reporting period. 
‘‘(3) OPT-IN
FOR
GROUP
HEALTH
INSURANCE
COVERAGE 
OFFERED BY A SPECIFIED LARGE EMPLOYER OR THAT IS A SPECI-
FIED LARGE PLAN.—In the case of group health insurance cov-
erage offered in connection with a group health plan that 
is offered by a specified large employer or is a specified large 
plan, such group health plan may, on an annual basis, for 
plan years beginning on or after the date that is 30 months 
after the date of enactment of this section, elect to require 
an entity providing pharmacy benefit management services on 
behalf of the health insurance issuer to submit to such group 
health plan a report that includes all of the information 
described in paragraph (2)(A), in addition to the information 
described in paragraph (2)(B). 
‘‘(4) PRIVACY REQUIREMENTS.— 
‘‘(A) IN GENERAL.—An entity providing pharmacy ben-
efit management services on behalf of a group health plan 
or a health insurance issuer offering group health insurance 
coverage shall report information under paragraph (1) in 
a manner consistent with the privacy regulations promul-
gated under section 13402(a) of the Health Information 
Technology for Economic and Clinical Health Act (42 U.S.C. 
17932(a)) and consistent with the privacy regulations 
promulgated under the Health Insurance Portability and 
Accountability Act of 1996 in part 160 and subparts A 
and E of part 164 of title 45, Code of Federal Regulations 
(or successor regulations) (referred to in this paragraph 
as the ‘HIPAA privacy regulations’) and shall restrict the 
use and disclosure of such information according to such 
privacy regulations and such HIPAA privacy regulations. 
‘‘(B) ADDITIONAL REQUIREMENTS.—
H. R. 7148—548 
‘‘(i) IN GENERAL.—An entity providing pharmacy 
benefit management services on behalf of a group 
health plan or health insurance issuer offering group 
health insurance coverage that submits a report under 
paragraph (1) shall ensure that such report contains 
only summary health information, as defined in section 
164.504(a) of title 45, Code of Federal Regulations (or 
successor regulations). 
‘‘(ii) RESTRICTIONS.—In carrying out this sub-
section, a group health plan shall comply with section 
164.504(f) of title 45, Code of Federal Regulations (or 
a successor regulation), and a plan sponsor shall act 
in accordance with the terms of the agreement 
described in such section. 
‘‘(C) RULE OF CONSTRUCTION.— 
‘‘(i) Nothing in this section shall be construed to 
modify the requirements for the creation, receipt, 
maintenance, or transmission of protected health 
information under the HIPAA privacy regulations. 
‘‘(ii) Nothing in this section shall be construed 
to affect the application of any Federal or State privacy 
or civil rights law, including the HIPAA privacy regula-
tions, the Genetic Information Nondiscrimination Act 
of 2008 (Public Law 110–233) (including the amend-
ments made by such Act), the Americans with Disabil-
ities Act of 1990 (42 U.S.C. 12101 et seq.), section 
504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), 
section 1557 of the Patient Protection and Affordable 
Care Act (42 U.S.C. 18116), title VI of the Civil Rights 
Act of 1964 (42 U.S.C. 2000d), and title VII of the 
Civil Rights Act of 1964 (42 U.S.C. 2000e). 
‘‘(D) WRITTEN NOTICE.—Each plan year, group health 
plans, including with respect to group health insurance 
coverage offered in connection with a group health plan, 
shall provide to each participant or beneficiary written 
notice informing the participant or beneficiary of the 
requirement for entities providing pharmacy benefit 
management services on behalf of the group health plan 
or health insurance issuer offering group health insurance 
coverage to submit reports to group health plans under 
paragraph (1), as applicable, which may include incor-
porating such notification in plan documents provided to 
the participant or beneficiary, or providing individual 
notification. 
‘‘(E) LIMITATION
TO
BUSINESS
ASSOCIATES.—A group 
health plan receiving a report under paragraph (1) may 
disclose such information only to the entity from which 
the report was received or to that entity’s business associ-
ates as defined in section 160.103 of title 45, Code of 
Federal Regulations (or successor regulations) or as per-
mitted by the HIPAA privacy regulations. 
‘‘(F) CLARIFICATION REGARDING PUBLIC DISCLOSURE OF 
INFORMATION.—Nothing in this section shall prevent an 
entity providing pharmacy benefit management services 
on behalf of a group health plan or health insurance issuer 
offering group health insurance coverage, from placing 
reasonable restrictions on the public disclosure of the
H. R. 7148—549 
information contained in a report described in paragraph 
(1), except that such plan, issuer, or entity may not— 
‘‘(i) restrict disclosure of such report to the Depart-
ment of Health and Human Services, the Department 
of Labor, or the Department of the Treasury; or 
‘‘(ii) prevent disclosure for the purposes of sub-
section (c), or any other public disclosure requirement 
under this section. 
‘‘(G) LIMITED FORM OF REPORT.—The Secretary shall 
define through rulemaking a limited form of the report 
under paragraph (1) required with respect to any group 
health plan established by a plan sponsor that is, or is 
affiliated with, a drug manufacturer, drug wholesaler, or 
other direct participant in the drug supply chain, in order 
to prevent anti-competitive behavior. 
‘‘(5) STANDARD FORMAT AND REGULATIONS.— 
‘‘(A) IN GENERAL.—Not later than 18 months after the 
date of enactment of this section, the Secretary shall specify 
through rulemaking a standard format for entities pro-
viding pharmacy benefit management services on behalf 
of group health plans and health insurance issuers offering 
group health insurance coverage, to submit reports required 
under paragraph (1). 
‘‘(B) ADDITIONAL
REGULATIONS.—Not later than 18 
months after the date of enactment of this section, the 
Secretary shall, through rulemaking, promulgate any other 
final regulations necessary to implement the requirements 
of this section. In promulgating such regulations, the Sec-
retary shall, to the extent practicable, align the reporting 
requirements under this section with the reporting require-
ments under section 725. 
‘‘(c) REQUIREMENT TO PROVIDE INFORMATION TO PARTICIPANTS 
OR BENEFICIARIES.—A group health plan, including with respect 
to group health insurance coverage offered in connection with a 
group health plan, upon request of a participant or beneficiary, 
shall provide to such participant or beneficiary— 
‘‘(1) the summary document described in subsection 
(b)(2)(B)(ii); and 
‘‘(2) the information described in subsection (b)(2)(A)(i)(III) 
with respect to a claim made by or on behalf of such participant 
or beneficiary. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to permit a health insurance issuer, group health 
plan, entity providing pharmacy benefit management services on 
behalf of a group health plan or health insurance issuer, or other 
entity to restrict disclosure to, or otherwise limit the access of, 
the Secretary to a report described in subsection (b)(1) or informa-
tion related to compliance with subsections (a), (b), or (c) of this 
section or section 502(c)(13) by such issuer, plan, or entity. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
ENTITY.—The term ‘applicable entity’ 
means— 
‘‘(A) an applicable group purchasing organization, drug 
manufacturer, distributor, wholesaler, rebate aggregator (or 
other purchasing entity designed to aggregate rebates), 
or associated third party;
H. R. 7148—550 
‘‘(B) any subsidiary, parent, affiliate, or subcontractor 
of a group health plan, health insurance issuer, entity 
that provides pharmacy benefit management services on 
behalf of such a plan or issuer, or any entity described 
in subparagraph (A); or 
‘‘(C) such other entity as the Secretary may specify 
through rulemaking. 
‘‘(2) APPLICABLE GROUP PURCHASING ORGANIZATION.—The 
term ‘applicable group purchasing organization’ means a group 
purchasing organization that is affiliated with or under common 
ownership with an entity providing pharmacy benefit manage-
ment services. 
‘‘(3) CONTRACTED
COMPENSATION.—The term ‘contracted 
compensation’ means the sum of any ingredient cost and dis-
pensing fee for a drug (inclusive of the out-of-pocket costs 
to the participant or beneficiary), or another analogous com-
pensation structure that the Secretary may specify through 
regulations. 
‘‘(4) GROSS
SPENDING.—The term ‘gross spending’, with 
respect to prescription drug benefits under a group health 
plan or health insurance coverage, means the amount spent 
by a group health plan or health insurance issuer on prescrip-
tion drug benefits, calculated before the application of rebates, 
fees, alternative discounts, or other remuneration. 
‘‘(5) NET SPENDING.—The term ‘net spending’, with respect 
to prescription drug benefits under a group health plan or 
health insurance coverage, means the amount spent by a group 
health plan or health insurance issuer on prescription drug 
benefits, calculated 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). 
‘‘(7) REMUNERATION.—The term ‘remuneration’ has the 
meaning given such term by the Secretary through rulemaking, 
which shall be reevaluated by the Secretary every 5 years. 
‘‘(8) SPECIFIED LARGE EMPLOYER.—The term ‘specified large 
employer’ means, in connection with a group health plan 
(including group health insurance coverage offered in connec-
tion with such a plan) established or maintained by a single 
employer, with respect to a calendar year or a plan year, 
as applicable, an employer who employed an average of at 
least 100 employees on business 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 ‘specified large plan’ 
means a group health plan (including group health insurance 
coverage offered in connection with such a plan) established 
or maintained by a plan sponsor described in clause (ii) or 
(iii) of section 3(16)(B) that had an average of at least 100 
participants on business days during the preceding 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)).’’; 
(B) in section 502 (29 U.S.C. 1132)—