Pharmacy Benefits Manager Accountability Act
This bill establishes reporting requirements for pharmacy benefit managers (PBMs) with respect to services provided to health insurance plans.
First, PBMs must report annually to the plan sponsor certain information about the PBM's services, including the amount of prescription drug copayment assistance funded by drug manufacturers, a list of covered drugs billed under the plan during the reporting period, and the total gross and net spending by the health plan on prescription drugs during the reporting period. PBMs also must submit specified elements of the report (e.g., the total gross spending on prescription drugs) to the Government Accountability Office (GAO). The report must comply with the privacy requirements under the Health Insurance Portability and Accountability Act of 1996.
The bill establishes civil penalties for violations of these requirements and provides for enforcement by the appropriate agencies.
GAO must report on the pharmacy networks of plans or PBMs, including whether such networks under common ownership with the plans or PBMs are designed to encourage plan enrollees to use network pharmacies over other pharmacies.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2679 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 2679
To amend the Public Health Service Act, the Employee Retirement Income
Security Act, and the Internal Revenue Code of 1984 to increase
oversight of pharmacy benefits manager services, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 18, 2023
Ms. Kuster (for herself, Mr. Carter of Georgia, Ms. Eshoo, and Mr.
Guthrie) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Education and the Workforce, and Ways and Means, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To amend the Public Health Service Act, the Employee Retirement Income
Security Act, and the Internal Revenue Code of 1984 to increase
oversight of pharmacy benefits manager services, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pharmacy Benefits Manager
Accountability Act''.
SEC. 2. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
(a) PHSA.--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 PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan or health insurance issuer offering group
health insurance coverage or an entity or subsidiary providing pharmacy
benefits management services on behalf of such a plan or issuer shall
not enter into a contract with a drug manufacturer, distributor,
wholesaler, subcontractor, rebate aggregator, or any associated third
party that limits the disclosure of information to plan sponsors in
such a manner that prevents the plan or issuer, or an entity or
subsidiary providing pharmacy benefits management services on behalf of
a plan or issuer, from making the reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, a health
insurance issuer offering group health insurance coverage or an
entity providing pharmacy benefits management services on
behalf of a group health plan or an issuer providing group
health insurance coverage shall submit to the plan sponsor (as
defined in section 3(16)(B) of the Employee Retirement Income
Security Act of 1974) of such group health plan or health
insurance coverage a report in accordance with this subsection
and make such report available to the plan sponsor in a
machine-readable format. Each such report shall include, with
respect to the applicable group health plan or health insurance
coverage--
``(A) as applicable, information collected from
drug manufacturers by such issuer or entity on the
total amount of copayment assistance dollars paid, or
copayment cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan or coverage;
``(B) a list of each drug covered by such plan,
issuer, or entity providing pharmacy benefits
management services that was dispensed during the
reporting period, including, with respect to each such
drug during the reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan or health insurance
coverage exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan or
health insurance coverage during the reporting period,
and, with respect to each such therapeutic category or
class of drugs, during the reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan or coverage--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan or
health insurance coverage on that
category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan or health insurance
coverage and its participants and
beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan or coverage during the reporting period,
before rebates and other manufacturer fees or
remuneration;
``(E) total amount received, or expected to be
received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party,
other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health
insurance coverage during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan or health insurance coverage during
the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefits
manager.
``(2) Privacy requirements.--Health insurance issuers
offering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in a
manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of
1996, and shall restrict the use and disclosure of such
information according to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents a health
insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan
from placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such issuer or
entity may not restrict disclosure of such report to
the Department of Health and Human Services, the
Department of Labor, the Department of the Treasury,
the Comptroller General of the United States, or
applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--A health insurance issuer offering
group health insurance coverage or an entity providing pharmacy
benefits management services on behalf of a group health plan
shall submit to the Comptroller General of the United States
each of the first 4 reports submitted to a plan sponsor under
paragraph (1) with respect to such coverage or plan, and other
such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and
redisclosure standards under paragraph (3), the standards
specified pursuant to paragraph (5), and such other information
that the Comptroller General determines necessary to carry out
the study under section 2(d) of the Pharmacy Benefits Manager
Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for health
insurance issuers and entities required to submit reports under
paragraph (4) to submit such reports in a standard format.
``(c) Enforcement.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor and the Secretary of the Treasury, shall
enforce this section.
``(2) Failure to provide timely information.--A health
insurance issuer or an entity providing pharmacy benefits
management services that violates subsection (a) or fails to
provide information required under subsection (b) shall be
subject to a civil monetary penalty in the amount of $10,000
for each day during which such violation continues or such
information is not disclosed or reported.
``(3) False information.--A health insurance issuer or
entity providing pharmacy benefits management services that
knowingly provides false information under this section shall
be subject to a civil money penalty in an amount not to exceed
$100,000 for each item of false information. Such civil money
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 subsection (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 proceeding
under section 1128A of the Social Security Act.
``(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
this section.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan, or
other entity to restrict disclosure to, or otherwise limit the access
of, the Department of Health and Human Services to a report described
in subsection (b)(1) or information related to compliance with
subsection (a) by such issuer, plan, or entity.
``(e) Definition.--In this section, 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 subsections (a) and (b) of section 2799A-
11)'' after ``part D''; and
(ii) in paragraph (2), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''; and
(B) in subsection (b)--
(i) in paragraph (1), by inserting ``(other
than subsections (a) and (b) of section 2799A-
11)'' after ``part D'';
(ii) in paragraph (2)(A), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''; and
(iii) in paragraph (2)(C)(ii), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''.
(b) ERISA.--
(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 PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan (or health insurance issuer offering group
health insurance coverage in connection with such a plan) or an entity
or subsidiary providing pharmacy benefits management services on behalf
of such a plan or issuer shall not enter into a contract with a drug
manufacturer, distributor, wholesaler, subcontractor, rebate
aggregator, or any associated third party that limits the disclosure of
information to plan sponsors in such a manner that prevents the plan or
issuer, or an entity or subsidiary providing pharmacy benefits
management services on behalf of a plan or issuer, from making the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, a health
insurance issuer offering group health insurance coverage or an
entity providing pharmacy benefits management services on
behalf of a group health plan or an issuer providing group
health insurance coverage shall submit to the plan sponsor (as
defined in section 3(16)(B)) of such group health plan or group
health insurance coverage a report in accordance with this
subsection and make such report available to the plan sponsor
in a machine-readable format. Each such report shall include,
with respect to the applicable group health plan or health
insurance coverage--
``(A) as applicable, information collected from
drug manufacturers by such issuer or entity on the
total amount of copayment assistance dollars paid, or
copayment cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan or coverage;
``(B) a list of each drug covered by such plan,
issuer, or entity providing pharmacy benefits
management services that was dispensed during the
reporting period, including, with respect to each such
drug during the reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan or health insurance
coverage exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan or
health insurance coverage during the reporting period,
and, with respect to each such therapeutic category or
class of drugs, during the reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan or coverage--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan or
health insurance coverage on that
category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan or health insurance
coverage and its participants and
beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan or coverage during the reporting period,
before rebates and other manufacturer fees or
remuneration;
``(E) total amount received, or expected to be
received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party,
other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health
insurance coverage during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan or health insurance coverage during
the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefits
manager.
``(2) Privacy requirements.--Health insurance issuers
offering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in a
manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of
1996, and shall restrict the use and disclosure of such
information according to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents a health
insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan
from placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such issuer or
entity may not restrict disclosure of such report to
the Department of Health and Human Services, the
Department of Labor, the Department of the Treasury,
the Comptroller General of the United States, or
applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--A health insurance issuer offering
group health insurance coverage or an entity providing pharmacy
benefits management services on behalf of a group health plan
shall submit to the Comptroller General of the United States
each of the first 4 reports submitted to a plan sponsor under
paragraph (1) with respect to such coverage or plan, and other
such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and
redisclosure standards under paragraph (3), the standards
specified pursuant to paragraph (5), and such other information
that the Comptroller General determines necessary to carry out
the study under section 2(d) of the Pharmacy Benefits Manager
Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for health
insurance issuers and entities required to submit reports under
paragraph (4) to submit such reports in a standard format.
``(c) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan, or
other entity to restrict disclosure to, or otherwise limit the access
of, the Department of Labor to a report described in subsection (b)(1)
or information related to compliance with subsection (a) by such
issuer, plan, or entity.
``(d) Definition.--In this section, the term `wholesale acquisition
cost' has the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''; and
(B) in section 502 (29 U.S.C. 1132)--
(i) in subsection (a)--
(I) in paragraph (6), by striking
``or (9)'' and inserting ``(9), or
(13)'';
(II) in paragraph (10), by striking
at the end ``or'';
(III) in paragraph (11), at the end
by striking the period and inserting
``; or''; and
(IV) by adding at the end the
following new paragraph:
``(12) by the Secretary, in consultation with the Secretary
of Health and Human Services, and the Secretary of the
Treasury, to enforce section 726.'';
(ii) in subsection (b)(3), by inserting
``and subsections (a)(12) and (c)(13)'' before
``, the Secretary is not''; and
(iii) in subsection (c), by adding at the
end the following new paragraph:
``(13) Secretarial enforcement authority relating to
oversight of pharmacy benefits manager services.--
``(A) Failure to provide timely information.--The
Secretary, in consultation with the Secretary of Health
and Human Services and the Secretary of the Treasury,
may impose a penalty against any health insurance
issuer or entity providing pharmacy benefits management
services that violates section 726(a) or fails to
provide information required under section 726(b) in
the amount of $10,000 for each day during which such
violation continues or such information is not
disclosed or reported.
``(B) False information.--The Secretary, in
consultation with the Secretary of Health and Human
Services and the Secretary of the Treasury, may impose
a penalty against a health insurance issuer or entity
providing pharmacy benefits management services that
knowingly provides false information under section 726
in an amount not to exceed $100,000 for each item of
false information. Such penalty shall be in addition to
other penalties as may be prescribed by law.
``(C) Waivers.--The Secretary may waive penalties
under subparagraph (A), or extend the period of time
for compliance with a requirement of section 726, for
an entity in violation of such section that has made a
good-faith effort to comply with such section.''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
relating to section 725 the following new item:
``Sec. 726. Oversight of pharmacy benefits manager services.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following:
``SEC. 9826. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan or an entity or subsidiary providing pharmacy
benefits management services on behalf of such a plan shall not enter
into a contract with a drug manufacturer, distributor, wholesaler,
subcontractor, rebate aggregator, or any associated third party that
limits the disclosure of information to plan sponsors in such a manner
that prevents the plan, or an entity or subsidiary providing pharmacy
benefits management services on behalf of a plan, from making the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, an entity
providing pharmacy benefits management services on behalf of a
group health plan shall submit to the plan sponsor (as defined
in section 3(16)(B) of the Employee Retirement Income Security
Act of 1974) of such group health plan a report in accordance
with this subsection and make such report available to the plan
sponsor in a machine-readable format. Each such report shall
include, with respect to the applicable group health plan--
``(A) as applicable, information collected from
drug manufacturers by such entity on the total amount
of copayment assistance dollars paid, or copayment
cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan;
``(B) a list of each drug covered by such plan or
entity providing pharmacy benefits management services
that was dispensed during the reporting period,
including, with respect to each such drug during the
reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan exceeded $10,000
during the reporting period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan
during the reporting period, and, with respect to each
such therapeutic category or class of drugs, during the
reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan on
that category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan and its participants
and beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan during the reporting period, before rebates
and other manufacturer fees or remuneration;
``(E) total amount received, or expected to be
received, by the health plan in drug manufacturer
rebates, fees, alternative discounts, and all other
remuneration received from the manufacturer or any
third party, other than the plan sponsor, related to
utilization of drug or drug spending under that health
plan during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan during the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's business
to the pharmacy benefits manager.
``(2) Privacy requirements.--Entities providing pharmacy
benefits management services on behalf of a group health plan
shall provide information under paragraph (1) in a manner
consistent with the privacy, security, and breach notification
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996, and shall
restrict the use and disclosure of such information according
to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents an
entity providing pharmacy benefits management services
on behalf of a group health plan from placing
reasonable restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such entity may not restrict
disclosure of such report to the Department of Health
and Human Services, the Department of Labor, the
Department of the Treasury, the Comptroller General of
the United States, or applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--An entity providing pharmacy benefits
management services on behalf of a group health plan shall
submit to the Comptroller General of the United States each of
the first 4 reports submitted to a plan sponsor under paragraph
(1) with respect to such plan, and other such reports as
requested, in accordance with the privacy requirements under
paragraph (2), the disclosure and redisclosure standards under
paragraph (3), the standards specified pursuant to paragraph
(5), and such other information that the Comptroller General
determines necessary to carry out the study under section 2(d)
of the Pharmacy Benefits Manager Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for
entities required to submit reports under paragraph (4) to
submit such reports in a standard format.
``(c) Enforcement.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor and the Secretary of Health and Human
Services, shall enforce this section.
``(2) Failure to provide timely information.--An entity
providing pharmacy benefits management services that violates
subsection (a) or fails to provide information required under
subsection (b) shall be subject to a civil monetary penalty in
the amount of $10,000 for each day during which such violation
continues or such information is not disclosed or reported.
``(3) False information.--An entity providing pharmacy
benefits management services that knowingly provides false
information under this section shall be subject to a civil
money penalty in an amount not to exceed $100,000 for each item
of false information. Such civil money 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 subsection (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 proceeding
under section 1128A of the Social Security Act.
``(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
this section.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a group health plan or other entity to restrict
disclosure to, or otherwise limit the access of, the Department of the
Treasury to a report described in subsection (b)(1) or information
related to compliance with subsection (a) by such plan or entity.
``(e) Definition.--In this section, the term `wholesale acquisition
cost' has the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986 is amended by adding at the end the following new item:
``Sec. 9826. Oversight of pharmacy benefits manager services.''.
(d) GAO Study.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report on--
(A) pharmacy networks of group health plans, health
insurance issuers, and entities providing pharmacy
benefits management services under such group health
plan or group or individual health insurance coverage,
including networks that have pharmacies that are under
common ownership (in whole or part) with group health
plans, health insurance issuers, or entities providing
pharmacy benefits management services or pharmacy
benefits administrative services under group health
plan or group or individual health insurance coverage;
(B) as it relates to pharmacy networks that include
pharmacies under common ownership described in
subparagraph (A)--
(i) whether such networks are designed to
encourage enrollees of a plan or coverage to
use such pharmacies over other network
pharmacies for specific services or drugs, and
if so, the reasons the networks give for
encouraging use of such pharmacies; and
(ii) whether such pharmacies are used by
enrollees disproportionately more in the
aggregate or for specific services or drugs
compared to other network pharmacies;
(C) whether group health plans and health insurance
issuers offering group or individual health insurance
coverage have options to elect different network
pricing arrangements in the marketplace with entities
that provide pharmacy benefits management services, the
prevalence of electing such different network pricing
arrangements;
(D) pharmacy network design parameters that
encourage enrollees in the plan or coverage to fill
prescriptions at mail order, specialty, or retail
pharmacies that are wholly or partially-owned by that
issuer or entity; and
(E) the degree to which mail order, specialty, or
retail pharmacies that dispense prescription drugs to
an enrollee in a group health plan or health insurance
coverage that are under common ownership (in whole or
part) with group health plans, health insurance
issuers, or entities providing pharmacy benefits
management services or pharmacy benefits administrative
services under group health plan or group or individual
health insurance coverage receive reimbursement that is
greater than the median price charged to the group
health plan or health insurance issuer when the same
drug is dispensed to enrollees in the plan or coverage
by other pharmacies included in the pharmacy network of
that plan, issuer, or entity that are not wholly or
partially owned by the health insurance issuer or
entity providing pharmacy benefits management services.
(2) Requirement.--The Comptroller General of the United
States shall ensure that the report under paragraph (1) does
not contain information that would allow a reader to identify a
specific plan or entity providing pharmacy benefits management
services or otherwise contain commercial or financial
information that is privileged or confidential.
(3) Definitions.--In this subsection, the terms ``group
health plan'', ``health insurance coverage'', and ``health
insurance issuer'' have the meanings given such terms in
section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
91).
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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