[House Report 115-684]
[From the U.S. Government Publishing Office]
115th Congress } { REPORT
HOUSE OF REPRESENTATIVES
2d Session } { 115-684
======================================================================
VETERANS OPIOID ABUSE PREVENTION ACT
_______
May 18, 2018.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Roe of Tennessee, from the Committee on Veterans' Affairs,
submitted the following
R E P O R T
[To accompany H.R. 3832]
[Including cost estimate of the Congressional Budget Office]
The Committee on Veterans' Affairs, to whom was referred
the bill (H.R. 3832) to direct the Secretary of Veterans
Affairs to enter into a memorandum of understanding with the
executive director of a national network of State-based
prescription monitoring programs under which Department of
Veterans Affairs health care providers shall query such
network, and for other purposes, having considered the same,
reports favorably thereon with amendments and recommends that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 4
Hearings......................................................... 5
Subcommittee Consideration....................................... 5
Committee Consideration.......................................... 5
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
Statement of General Performance Goals and Objectives............ 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Earmarks and Tax and Tariff Benefits............................. 6
Committee Cost Estimate.......................................... 6
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 8
Advisory Committee Statement..................................... 8
Constitutional Authority Statement............................... 8
Applicability to Legislative Branch.............................. 8
Statement on Duplication of Federal Programs..................... 8
Disclosure of Directed Rulemaking................................ 8
Section-by-Section Analysis of the Legislation................... 8
Changes in Existing Law Made by the Bill as Reported............. 9
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Veterans Opioid Abuse Prevention
Act''.
SEC. 2. DEPARTMENT OF VETERANS AFFAIRS PARTICIPATION IN NATIONAL
NETWORK OF STATE-BASED PRESCRIPTION DRUG MONITORING
PROGRAMS.
(a) In General.--Chapter 17 of title 38, United States Code, is
amended by inserting after section 1730A the following new section:
``Sec. 1730B. Access to State prescription drug monitoring programs
``(a) Access to Programs.--(1) Any licensed health care provider or
delegate of such a provider shall be considered an authorized recipient
or user for the purpose of querying and receiving data from the
national network of State-based prescription drug monitoring programs
to support the safe and effective prescribing of controlled substances
to covered patients.
``(2) Under the authority granted by paragraph (1)--
``(A) licensed health care providers or delegates of such
providers shall query such network in accordance with
applicable regulations and policies of the Veterans Health
Administration; and
``(B) notwithstanding any general or specific provision of
law, rule, or regulation of a State, no State may restrict the
access of licensed health care providers or delegates of such
providers from accessing that State's prescription drug
monitoring programs.
``(3) No State shall deny or revoke the license, registration, or
certification of a licensed health care provider or delegate who
otherwise meets that State's qualifications for holding the license,
registration, or certification on the basis that the licensed health
care provider or delegate has queried or received data, or attempt to
query or receive data, from the national network of State-based
prescription drug monitoring programs under this section.
``(b) Covered Patients.--For purposes of this section, a covered
patient is a patient who--
``(1) receives a prescription for a controlled substance; and
``(2) is not receiving palliative care or enrolled in hospice
care.
``(c) Definitions.--In this section:
``(1) The term `controlled substance' has the meaning given
such term in section 102(6) of the Controlled Substances Act
(21 U.S.C. 802(6)).
``(2) The term `delegate' means a person or automated system
accessing the national network of State-based prescription
monitoring programs at the direction or under the supervision
of a licensed health care provider.
``(3) The term `licensed health care provider' means a health
care provider employed by the Department who is licensed,
certified, or registered within any State to fill or prescribe
medications within the scope of his or her practice as a
Department employee.
``(4) The term `national network of State-based prescription
monitoring programs' means an interconnected nation-wide system
that facilitates the transfer to State prescription drug
monitoring program data across State lines.
``(5) The term `State' means a State, as defined in section
101(20) of this title, or a political subdivision of a
State.''.
(b) Clerical Amendment.--The table of sections at the beginning of
chapter 17 of such title is amended by inserting after the item
relating to section 1730A the following new item:
``1730B. Access to State prescription drug monitoring programs.''.
Amend the title so as to read:
A bill to amend title 38, United States Code, to provide
for access by Department of Veterans Affairs health care
providers to State prescription drug monitoring programs.
Amendment in the Nature of a Substitute to H.R. 3832 Offered by Mr.
Dunn of Florida
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Veterans Opioid Abuse
Prevention Act''.
SEC. 2. DEPARTMENT OF VETERANS AFFAIRS PARTICIPATION IN NATIONAL
NETWORK OF STATE-BASED PRESCRIPTION DRUG MONITORING
PROGRAMS.
(a) In General.--Chapter 17 of title 38, United States Code,
is amended by inserting after section 1730A the following new
section:
``Sec. 1730B. Access to State prescription drug monitoring programs
``(a) Access to Programs.--(1) Any licensed health care
provider or delegate of such a provider shall be considered an
authorized recipient or user for the purpose of querying and
receiving data from the national network of State-based
prescription drug monitoring programs to support the safe and
effective prescribing of controlled substances to covered
patients.
``(2) Under the authority granted by paragraph (1)--
``(A) licensed health care providers or delegates of
such providers shall query such network in accordance
with applicable regulations and policies of the
Veterans Health Administration; and
``(B) notwithstanding any general or specific
provision of law, rule, or regulation of a State, no
State may restrict the access of licensed health care
providers or delegates of such providers from accessing
that State's prescription drug monitoring programs.
``(3) No State shall deny or revoke the license,
registration, or certification of a licensed health care
provider or delegate who otherwise meets that State's
qualifications for holding the license, registration, or
certification on the basis that the licensed health care
provider or delegate has queried or received data, or attempt
to query or receive data, from the national network of State-
based prescription drug monitoring programs under this section.
``(b) Covered Patients.--For purposes of this section, a
covered patient is a patient who--
``(1) receives a prescription for a controlled
substance; and
``(2) is not receiving palliative care or enrolled in
hospice care.
``(c) Definitions.--In this section:
``(1) The term `controlled substance' has the meaning
given such term in section 102(6) of the Controlled
Substances Act (21 U.S.C. 802(6)).
``(2) The term `delegate' means a person or automated
system accessing the national network of State-based
prescription monitoring programs at the direction or
under the supervision of a licensed health care
provider.
``(3) The term `licensed health care provider' means
a health care provider employed by the Department who
is licensed, certified, or registered within any State
to fill or prescribe medications within the scope of
his or her practice as a Department employee.
``(4) The term `national network of State-based
prescription monitoring programs' means an
interconnected nation-wide system that facilitates the
transfer to State prescription drug monitoring program
data across State lines.
``(5) The term `State' means a State, as defined in
section 101(20) of this title, or a political
subdivision of a State.''.
(b) Clerical Amendment.--The table of sections at the
beginning of chapter 17 of such title is amended by inserting
after the item relating to section 1730A the following new
item:
``1730B. Access to State prescription drug monitoring programs.''.
Amend the title so as to read: ``A bill to amend title 38,
United States Code, to provide for access by Department of
Veterans Affairs health care providers to State prescription
drug monitoring programs.''.
Purpose and Summary
H.R. 3832, as amended, the ``Veterans Opioid Abuse
Prevention Act'' would allow for the greater sharing of
information between the Department of Veterans Affairs (VA) and
state-based prescription drug monitoring programs (PDMPs).
Representative Neal Dunn of Florida introduced H.R. 3832 on
September 26, 2017.
Background and Need for Legislation
The Centers for Disease Control and Prevention (CDC)
defines a PDMP as an electronic database that tracks controlled
substance prescriptions in a state and provides information
about prescribing and patient patterns and behaviors.\1\ PDMPs
have been shown to improve prescribing, inform clinical
practice, protect at-risk patients, and decrease substance
abuse treatment admissions.\2\
---------------------------------------------------------------------------
\1\What States Need to Know about PDMPs. Centers for Disease
Control and Prevention. https://www.cdc.gov/drugoverdose/pdmp/
states.html. Accessed April 30, 2018.
\2\Ibid.
---------------------------------------------------------------------------
In 2011, the National Association of Boards of Pharmacy
(NABP) developed and launched the Prescription Monitoring
Program (PMP) InterConnect to facilitate the secure exchange of
information across state lines by PDMPs.\3\ According to NABP,
PDMPs are, ``. . . are enhanced by PMP InterConnect because
[it] provides the means for physicians and pharmacists to more
easily identify patients with prescription drug abuse and
misuse problems, especially if those patients are crossing
state lines to obtain drugs.''\4\ Currently 44 states and
Washington, D.C. participate in PMP InterConnect with several
additional states intending to begin sharing data using PMP
InterConnect.\5\\6\
---------------------------------------------------------------------------
\3\NABP PMP InterConnect: The Only National Network of State-Based
PMPs. National Association of Boards of Pharmacy. https://
nabp.pharmacy/initiatives/pmp-interconnect/. Accessed April 30, 2018.
\4\Ibid.
\5\United States Cong. House Committee on Veterans' Affairs.
Legislative Hearing. April 17, 2018. 115th Cong. 2nd sess. Washington:
GPO, 2018 (statement from the Honorable Neal Dunn, U.S. House of
Representatives, 2nd District, Florida).
\6\NABP PMP InterConnect: The Only National Network of State-Based
PMPs. National Association of Boards of Pharmacy. https://
nabp.pharmacy/initiatives/pmp-interconnect/. Accessed April 30, 2018.
---------------------------------------------------------------------------
Section 5701(l) of title 38 United States Code (U.S.C.)
requires VA to disclose information to PDMPs for either a
veteran or the dependent of a veteran who is prescribed a
controlled substance through VA ``to the extent necessary to
prevent misuse or diversion of prescription medications.''
Veterans Health Administration (VHA) Directive 1306 provides VA
national policy for querying PDMPs.\7\ It requires PDMPs to be
queried prior to initiating therapy with a controlled
substance, annually at a minimum, and more often when
clinically indicated unless the patient is enrolled in hospice
care or receives a controlled substance prescription for five
days or less without refills.\8\ The results of such query are
required to be documented in the patient's medical record and
are subject to limitations imposed by state law, in which case
providers and prescribers are required to conform to the
policies and recommendations of their state licensure.\9\
According to VA, this policy allows providers to identify
patients receiving controlled substances from multiple
providers which may assist in preventing accidental or
intentional misuse or diversion and in the detection,
prevention, and early treatment of substance use disorders.\10\
However, the policy does not allow VA to track controlled
substance prescriptions across multiple states since VA lacks
the authority to use a system like PMP InterConnect.
---------------------------------------------------------------------------
\7\VHA Directive 1306. Query State Prescription Drug Monitoring
Programs. October 19, 2016.
\8\Ibid.
\9\Ibid.
\10\Ibid.
---------------------------------------------------------------------------
Section 2 of the bill would require VA to enter into an
agreement with a national network of PDMPs to allow for the
monitoring of controlled substance prescriptions written in
participating states. It would also require VA health care
providers practicing in states that do not have a PDMP to join
the network of the closest state that does have a PDMP.
Hearings
On April 17, 2018, the Subcommittee on Health conducted a
legislative hearing on a number of bills including H.R. 3832.
The following witnesses testified:
The Honorable Beto O'Rourke, U.S. House of
Representatives, 16th District, Texas; The Honorable
Tim Walberg, U.S. House of Representatives, 7th
District, Michigan; The Honorable Neal Dunn, U.S. House
of Representatives, 2nd District, Florida; The
Honorable Luis Correa, U.S. House of Representatives,
46th District, California; The Honorable Mike Coffman,
U.S. House of Representatives, 6th District, Colorado;
Louis J. Celli, Director, National Veterans Affairs and
Rehabilitation Division, The American Legion; Adrian M.
Atizado, Deputy National Legislative Director, Disabled
American Veterans; Sarah S. Dean, Associate Legislative
Director, Paralyzed Veterans of America; and Kayda
Keleher, Associate Director, National Legislative
Service, Veterans of Foreign Wars of the United States.
Statements for the record were submitted by:
The Elizabeth Dole Foundation; the Independence Fund;
Veteran Cannabis Project; Wounded Warrior Project; and
Iraq and Afghanistan Veterans of America.
Subcommittee Consideration
There was no Subcommittee consideration of H.R. 3832.
Committee Consideration
On May 8, 2018, the full Committee met in open markup
session, a quorum being present, and ordered H.R. 3832, as
amended, to be reported favorably to the House of
Representatives by voice vote. During consideration of the
bill, the following amendment was considered and agreed to by
voice vote:
An amendment in the nature of a substitute offered by
Representative Neal Dunn of Florida.
Committee Votes
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, there were no recorded votes
taken on amendments or in connection with ordering H.R. 3832,
as amended, reported to the House. A motion by Representative
Tim Walz of Minnesota, Ranking Member of the Committee on
Veterans' Affairs, to report H.R. 3832, as amended, favorably
to the House of Representatives was agreed to by voice vote.
Committee Oversight Findings
In compliance with clause 3(c)(1) of rule XIII and clause
(2)(b)(1) of rule X of the Rules of the House of
Representatives, the Committee's oversight findings and
recommendations are reflected in the descriptive portions of
this report.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the Committee's performance
goals and objectives are to improve communication between VA
and state-based prescription drug monitoring programs in order
to ensure the safe, effective, and appropriate prescribing of
controlled substances to veteran patients.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee adopts as its
own the estimate of new budget authority, entitlement
authority, or tax expenditures or revenues contained in the
cost estimate prepared by the Director of the Congressional
Budget Office pursuant to section 402 of the Congressional
Budget Act of 1974.
Earmarks and Tax and Tariff Benefits
H.R. 3832, as amended, does not contain any Congressional
earmarks, limited tax benefits, or limited tariff benefits as
defined in clause 9 of rule XXI of the Rules of the House of
Representatives.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
3832, as amended, prepared by the Director of the Congressional
Budget Office pursuant to section 402 of the Congressional
Budget Act of 1974.
Congressional Budget Office Cost Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
for H.R. 3832, as amended, provided by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, May 11, 2018.
Hon. Phil Roe, M.D.,
Chairman, Committee on Veterans' Affairs,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 3832, the Veterans
Opioid Abuse Prevention Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Ann E.
Futrell.
Sincerely,
Keith Hall,
Director.
Enclosure.
H.R. 3832--Veterans Opioid Abuse Prevention Act
H.R. 3832 would require medical providers at the Department
of Veterans Affairs (VA) who prescribe controlled substances to
veterans to seek information regarding those veterans from
state programs that monitor prescription drug use. Under
current policy, VA medical providers are required to query
those state programs when prescribing such drugs. This bill
would, therefore, codify VA's existing practice. As a result,
CBO estimates that implementing the bill would cost less than
$500,000 over the 2019-2023 period, primarily to prepare the
necessary regulations. That spending would be subject to the
availability of appropriated funds.
Enacting H.R. 3832 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
CBO estimates that enacting H.R. 3832 would not increase
net direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2029.
H.R. 3832 would impose intergovernmental mandates as
defined in the Unfunded Mandates Reform Act (UMRA). The bill
would require state-operated prescription drug monitoring
programs (PDMPs) to allow VA personnel to access the databases
and would preempt state laws by limiting states' authority to
revoke or deny medical licenses of VA personnel who access PDMP
data. CBO estimates that the incremental cost to provide access
to PDMP databases by VA personnel would be minimal because
PDMPs are already operational in nearly every state and
servicing new users would not require significant changes to
the programs. Although the preemption would limit the
application of state laws, it would impose no duty on states
that would result in additional spending or loss of a revenues.
Therefore, the costs of the mandates would not exceed the
threshold established in UMRA ($80 million in 2018, adjusted
annually for inflation).
The bill contains no private-sector mandates as defined in
UMRA.
The CBO staff contact for this estimate is Ann E. Futrell
(for federal costs) and Andrew Laughlin (for mandates). The
estimate was reviewed by Leo Lex, Deputy Assistant Director for
Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates regarding H.R. 3832, as amended, prepared by the
Director of the Congressional Budget Office pursuant to section
423 of the Unfunded Mandates Reform Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
3832, as amended.
Statement of Constitutional Authority
Pursuant to Article I, section 8 of the United States
Constitution, H.R. 3832, as amended, is authorized by Congress'
power to ``provide for the common Defense and general Welfare
of the United States.''
Applicability to Legislative Branch
The Committee finds that H.R. 3832, as amended, does not
relate to the terms and conditions of employment or access to
public services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Statement on Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII of the Rules of the
House of Representatives, the Committee finds that no provision
of H.R. 3832, as amended, establishes or reauthorizes a program
of the Federal Government known to be duplicative of another
Federal program, a program that was included in any report from
the Government Accountability Office to Congress pursuant to
section 21 of Public Law 111-139, or a program related to a
program identified in the most recent Catalog of Federal
Domestic Assistance.
Disclosure of Directed Rulemaking
Pursuant to section 3(i) of H. Res. 5, 115th Cong. (2017),
the Committee estimates that H.R. 3832, as amended, contains no
directed rulemaking that would require the Secretary to
prescribe regulations.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 of the bill would establish a short title for
3832, as amended, of the ``Veterans Opioid Abuse Prevention
Act.''
Section 2. Department of Veterans Affairs participation in national
network of State-based prescription drug monitoring programs
Section 2(a) of the bill would amend Chapter 17 of title 38
U.S.C. by inserting after section 1730A a new section ``1730B.
Access to State prescription drug monitoring programs.''
The new section 1730B(a) would require that any licensed
health care provider or delegate of such provider is required
to be considered an authorized recipient or user for the
purpose of querying and receiving data from the national
network of State-based prescription drug monitoring programs to
support the safe and effective prescribing of controlled
substances to covered patients. It would also require licensed
health care providers or delegates of such providers to query
such network in accordance with applicable VHA regulations and
policies and, notwithstanding any general or specific provision
of law, rule, or regulation of a State, no State is authorized
to restrict the access of licensed health care providers or
delegates of such providers from accessing that State's
prescription drug monitoring programs. It would further require
that no State deny or revoke the license, registration, or
certification of a licensed health care provider or delegate
who otherwise meets that State's qualifications for holding the
license, registration, or certification on the basis that the
licensed health care provider or delegate has queried or
received data, or attempt to query or receive data, from the
national network of State-based prescription drug monitoring
programs under this section.
The new section 1730B(b) would stipulate that, for the
purpose of this section, a covered patient is a patient who
receives a prescription for a controlled substance and is not
receiving palliative care or enrolled in hospice care.
The new section 1730B(c) would define the term:
``controlled substance'' as having the meaning given such term
in section 102(6) of the Controlled Substances Act (21 U.S.C.
802(6)); ``delegate'' as meaning a person or automated system
accessing the national network of State-based prescription
monitoring programs at the direction or under the supervision
of a licensed health care provider; ``licensed health care
provider'' as meaning a health care provider employed by VA who
is licensed, certified, or registered within any State to fill
or prescribe medications within the scope of his or her
practice as a VA employee; ``national network of State-based
prescription monitoring programs'' as meaning an interconnected
nation-wide system that facilitates the transfer to State
prescription drug monitoring program data across State lines;
``State'' as meaning a State as defined in section 101(20) of
title 38 U.S.C. or a political subdivision of a State.
Section 2(b) of the bill would amend the table of sections
at the beginning of chapter 17 of title 38 U.S.C. by inserting
after the item relating to section 1730A the following new
item: ``1730B. Access to State prescription drug monitoring
programs.''.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
TITLE 38, UNITED STATES CODE
* * * * * * *
PART II--GENERAL BENEFITS
* * * * * * *
CHAPTER 17--HOSPITAL, NURSING HOME, DOMICILIARY, AND MEDICAL CARE
SUBCHAPTER I--GENERAL
Sec.
1701. Definitions.
* * * * * * *
SUBCHAPTER III--MISCELLANEOUS PROVISIONS RELATING TO HOSPITAL AND
NURSING HOME CARE AND MEDICAL TREATMENT OF VETERANS
* * * * * * *
1730B. Access to State prescription drug monitoring programs.
* * * * * * *
SUBCHAPTER III--MISCELLANEOUS PROVISIONS RELATING TO HOSPITAL AND
NURSING HOME CARE AND MEDICAL TREATMENT OF VETERANS
* * * * * * *
Sec. 1730B. Access to State prescription drug monitoring programs
(a) Access to Programs.--(1) Any licensed health care
provider or delegate of such a provider shall be considered an
authorized recipient or user for the purpose of querying and
receiving data from the national network of State-based
prescription drug monitoring programs to support the safe and
effective prescribing of controlled substances to covered
patients.
(2) Under the authority granted by paragraph (1)--
(A) licensed health care providers or delegates of
such providers shall query such network in accordance
with applicable regulations and policies of the
Veterans Health Administration; and
(B) notwithstanding any general or specific provision
of law, rule, or regulation of a State, no State may
restrict the access of licensed health care providers
or delegates of such providers from accessing that
State's prescription drug monitoring programs.
(3) No State shall deny or revoke the license, registration,
or certification of a licensed health care provider or delegate
who otherwise meets that State's qualifications for holding the
license, registration, or certification on the basis that the
licensed health care provider or delegate has queried or
received data, or attempt to query or receive data, from the
national network of State-based prescription drug monitoring
programs under this section.
(b) Covered Patients.--For purposes of this section, a
covered patient is a patient who--
(1) receives a prescription for a controlled
substance; and
(2) is not receiving palliative care or enrolled in
hospice care.
(c) Definitions.--In this section:
(1) The term ``controlled substance'' has the meaning
given such term in section 102(6) of the Controlled
Substances Act (21 U.S.C. 802(6)).
(2) The term ``delegate'' means a person or automated
system accessing the national network of State-based
prescription monitoring programs at the direction or
under the supervision of a licensed health care
provider.
(3) The term ``licensed health care provider'' means
a health care provider employed by the Department who
is licensed, certified, or registered within any State
to fill or prescribe medications within the scope of
his or her practice as a Department employee.
(4) The term ``national network of State-based
prescription monitoring programs'' means an
interconnected nation-wide system that facilitates the
transfer to State prescription drug monitoring program
data across State lines.
(5) The term ``State'' means a State, as defined in
section 101(20) of this title, or a political
subdivision of a State.
* * * * * * *
[all]