Proposed Rule2026-10084
Expanding Access to State Prescription Drug Monitoring Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 20, 2026
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) proposes to amend its regulation that governs disclosure of information to and querying of State prescription drug monitoring programs (PDMPs). The rule would clarify certain statutory definitions, including the definition of delegate and licensed health care provider. In doing so, VA would eliminate confusion as to who VA would allow to query the PDMP and would better protect these individuals from any possible adverse action by a State, as long as they are acting within the scope of their VA employment or, if applicable, scope of their contract. The rule would also mandate that VA disclose the specified information to State PDMPs to the extent necessary to prevent misuse and diversion of prescription medicines. This proposed rule would promote safe and effective prescribing of controlled substances to covered individuals and patients who receive VA health care.
Full Text
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<title>Federal Register, Volume 91 Issue 97 (Wednesday, May 20, 2026)</title>
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[Federal Register Volume 91, Number 97 (Wednesday, May 20, 2026)]
[Proposed Rules]
[Pages 29407-29413]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10084]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AS73
Expanding Access to State Prescription Drug Monitoring Programs
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
regulation that governs disclosure of information to and querying of
State prescription drug monitoring programs (PDMPs). The rule would
clarify certain statutory definitions, including the definition of
delegate and licensed health care provider. In doing so, VA would
eliminate confusion as to who VA would allow to query the PDMP and
would better protect these individuals from any possible adverse action
by a State, as long as they are acting within the scope of their VA
employment or, if applicable, scope of their contract. The rule would
also mandate that VA disclose the specified information to State PDMPs
to the extent necessary to prevent misuse and diversion of prescription
medicines. This proposed rule would promote safe and effective
prescribing of controlled substances to covered individuals and
patients who receive VA health care.
DATES: Comments must be received on or before July 20, 2026.
ADDRESSES: You may submit comments through <a href="http://www.regulations.gov">www.regulations.gov</a> under
RIN 2900-AS73. That website includes a plain-language summary of this
rulemaking. Instructions for accessing agency documents, submitting
comments, and viewing the rulemaking docket, are available on
<a href="http://www.regulations.gov">www.regulations.gov</a> under ``FAQ.''
FOR FURTHER INFORMATION CONTACT: Friedhelm Sandbrink, MD, National
Program Director for Pain Management, Opioid Safety and Prescription
Drug Monitoring Programs, Veterans Health Administration, (202) 745-
8145.
SUPPLEMENTARY INFORMATION:
Background/Statutory Authority
Broadly speaking, this rulemaking would codify in a single
regulation and amend 38 Code of Federal Regulation (CFR) 1.515 to
include: (1) the general rules and definitions applicable to all
activities described in this section; (2) the rules on mandated
disclosures of information to PDMPs required by 38 United States Code
(U.S.C.) 5701(l) to the extent necessary to prevent misuse and
diversion of prescription medicines; and (3) the rules governing
querying of State PDMPs under 38 U.S.C. 1730B for covered patients to
support the safe and effective prescribing of controlled substances.
These amendments to section 1.515 are driven by relatively recent
laws. First, VA proposes to amend section 1.515 to accord with the
amendment made to Subsection 5701(l) by section 914 of Title IX, of
Public Law 114-198, July 22, 2016, the Comprehensive Addiction and
Recovery Act of 2016. Section 901 of Title IX establishes the short
title for this Act to be the Jason Simcakoski Memorial and Promise Act
[[Page 29408]]
and this short title will be used herein. Specifically, section 914 of
the Jason Simcakoski Memorial and Promise Act changed the permissive
authority in 5701(l), added in December 2011, to require, under
regulations to be prescribed, VA to disclose information about a
covered individual to a State PDMP, including a program approved by the
Secretary of Health and Human Services under section 399O of the Public
Health Service Act (42 U.S.C. 280g-3) to the extent necessary to
prevent misuse and diversion of prescription medicines. VA would amend
current section 1.515 to reflect that disclosures are required, not
just permissive, if they meet the terms of Subsection 5701(l). Mandated
disclosures, like ones done under VA's prior discretionary authority,
include information needed for PDMPs to document the prescriptions of
controlled substances and include demographic information of the
individual who was prescribed the controlled substance, information
about the prescribed controlled substance, and prescriber information.
It is also worth noting that records of the identity, diagnosis,
prognosis, or treatment of any patient or subject that are maintained
in connection with the performance of any program or activity
(including education, training, treatment, rehabilitation, or research)
relating to drug abuse, alcoholism or alcohol abuse, infection with
human immunodeficiency virus, or sickle cell anemia, which is carried
out by or for VA, are protected as confidential by 38 U.S.C. 7332,
except as provided in subsections (e) and (f) of that section, and
(section 5701 to the contrary notwithstanding) such records may be
disclosed only for the purposes and under the circumstances expressly
authorized under subsection (b) of section 7332. Section 7332(b)(2)(G)
authorizes VA to disclose such records, without the consent of the
respective patient or subject, to a State PDMP to the extent necessary
to prevent misuse and diversion of prescription medicines. While
disclosure of information authorized pursuant to subsection 7332(b) is
usually permissive, the mandatory nature of subsection 5701(l) requires
the disclosure of information that falls within the purview of both
subsections.
Section 2 of Public Law 115-86, enacted on November 21, 2017, also
amended subsection 5701(l) by replacing the reference to a veteran or
the dependent of a veteran with the term covered individual. It further
added a definition of covered individual to mean an individual who is
dispensed medication prescribed by an employee of the Department or by
a non-Department provider authorized to prescribe such medication by
the Department. This rulemaking would make these conforming amendments.
In addition to these two laws, section 134 of public law 115-182,
June 6, 2018, the John S. McCain III, Daniel K. Akaka, and Samuel R.
Johnson VA Maintaining Internal Systems and Strengthening Integrated
Outside Networks Act of 2018 (VA MISSION Act of 2018) added new section
1730B to title 38, United States Code. It deems, by operation of law,
VA licensed health care providers and delegates to be authorized
recipients or users (herein referred to as authorized users) for
purposes of querying and receiving data from State-based PDMPs, or any
individual State or regional prescription drug monitoring program, to
support the safe and effective prescribing of controlled substances to
covered patients.
Under section 1730B, the grant of authorized user status is
irrespective of any State law, rule, or regulation that would otherwise
restrict such access, thereby reducing current impediments to VA
access. Without this status, States could deny VA licensed health care
providers and their delegates access to their PDMPs based upon
individual state-imposed requirements, which may include the need for
licensure in the State, even though VA health care providers are not
restricted to practice only in the State of their licensure. Section
1730B surmounts this operational hurdle by deeming VA licensed health
care providers and their delegates to be authorized users with a right
of access, notwithstanding State imposed requirements that would
otherwise apply. States are, in turn, obligated to grant access to VA
licensed health care providers and their delegates.
Section 1730B also provides that no State may 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 provider or delegate queried or received data or attempted to
query or receive data for a covered patient from the national network
of State-based PDMPs, or any individual State or regional PDMP, under
this section.
Further, although VA licensed health care providers and delegates
deemed to be authorized users for covered patients are not subject to
an individual State's PDMP requirements insofar as the State
requirements conflict with section 1730B, Federal standards still apply
to VA's use of State's PDMPs. VA licensed health care providers and
delegates would be required by subsection 1730B(a)(2)(A) to query
PDMPs, including an individual State or regional prescription drug
monitoring program, in accordance with applicable VA regulations and
policies. This is in line with VA's previously implemented regulation,
38 CFR 17.419(b)(ii), which states that if a State law or license,
registration, certification, or other requirement prevents or unduly
interferes with a health care professional's practice within the scope
of their VA employment, the health care professional is required to
abide by their Federal duties even when a State law, registration,
certification, or other requirement conflicts or unduly interferes with
such standard.
Subsection 1730B(a)(2)(A) also serves as a check on potential
misuse or abuse by providers or delegates of State PDMPs, as VA is only
authorized, by 38 CFR 17.38(b), to provide care that is in accord with
generally accepted standards of medical practice and needed to promote,
preserve, or restore health, and VHA regulations and policies align
with these requirements. Therefore, licensed health care practitioners
and their delegates could only rely on their authorized user status
under section 1730B to check PDMPs when consistent with the standards
of section 17.38(b).
Lastly, although section 1730B(b)(2) excludes individuals receiving
palliative care or enrolled in hospice care from the definition of
covered patients, this authority does not prevent VA licensed health
care providers and delegates from accessing State PDMPs for such
patients, so long as States allow VA licensed health care providers and
delegates access. VA licensed health care providers or delegates would
continue to perform this clinical activity for this population, when
reasonably possible, as they have previous to the enactment of 1730B on
VA's general treatment authority to provide necessary medical care to
veterans enrolled in VA's health care system (38 U.S.C. 1710, 1705).
Section 1.515
Short Title
To reflect the inclusion of additional authorities and consequent
expanded scope, the short title of 38 CFR 1.515 would be amended to
read: Disclosure of Information to and Querying of State Prescription
Drug Monitoring Programs.
[[Page 29409]]
Section 1.515(a) Definitions
The proposed rulemaking would renumber current paragraph (b) as new
paragraph (a) and provide the definitions applicable to proposed
section 1.515.
VA would define the term controlled substance to retain the same
definition as found in current section 1.515(b), with no edits.
VA proposes to use the term covered individual to apply to
disclosures of information to PDMPs. Covered individual would be
assigned the same definition as in 38 U.S.C. 5701(l)(2), upon which the
term's usage in this proposed rulemaking is based, as discussed above
in the Background/Statutory Authority section.
Covered patient would be clarified with respect to both prongs of
its definition in section 1730B. Subsection 1730(b)(1) partially
defines a covered patient as one who receives a prescription for a
controlled substance. VA proposes to broadly interpret the phrase
receives a prescription because, in clinical practice, the prescribing
of a medication may refer to the ordering of a medication or to a
recommendation for the use of a medication. Before a licensed health
care provider orders or recommends the use of any medication, the
provider is required by applicable clinical standards of care to
determine, based on the exercise of clinical judgment, that the subject
medication would not be unsafe or contraindicated for the patient or
duplicative of other medications that have been prescribed for the
patient outside the VA health care system. Data needed to inform these
decisions is particularly important when clinically evaluating the need
or dosage of any controlled substance. VA, therefore, proposes to
define covered patient to mean a patient who is prescribed, is
dispensed, or receives a prescription for a controlled substance, or is
being considered for a prescription of a controlled substance when
their care satisfies the additional restrictions in 38 U.S.C.
1730B(b)(2). VA does not believe that Congress intended an
interpretation in which a patient would not be covered until after a
licensed health care provider had already decided to initiate a
prescription and such prescription had already been dispensed to the
patient, as that would defeat the statute's purpose of facilitating
safe and effective prescribing of controlled substances. See, for
example, 164 Cong. Rec. H4014-01 (May 16, 2018) (Rep. Dunn stating that
``my legislative initiative increases transparency in opioid
prescribing at the VA by allowing doctors to identify high users of
controlled drugs who are therefore at risk for addiction. My language
in the VA MISSION Act instructs the VA to do what most private doctors
already do: connect to the prescription drug monitoring databases
nationwide so that no one slips through the cracks.'')
Section 1730B(c)(2) defines the term delegate to mean a person or
automated system accessing the national network of State-based
prescription monitoring programs, or any individual State or regional
prescription drug monitoring program, at the direction or under the
supervision of a licensed health care provider. VA sometimes relies on
licensed independent prescribers to deliver care to our patients
pursuant to contractual and other arrangements. Because these
individuals are not VA employees, they do not meet the definition of
licensed health care providers under section 1730B(c)(3). However, they
act at the direction of licensed health care providers, such as the VA
medical facility chief of staff. Veterans should benefit from receiving
the same high standard of care regardless if delivered by a VA employee
or these contracted providers, who practice health care throughout our
system. This requires their access to all vital data and systems,
including PDMPs. VA provides specific care through contract that VA
does not include in the definition of contract providers because such
care is neither at the direction nor under the supervision of a VA
licensed health care provider in the same manner as the individuals
discussed above. Examples include, but are not limited to, 38 U.S.C.
1703 (Veterans Community Care Program), 1720J, and Public Law 118-42
Div. A, Sec. 234 (In vitro fertilization and other fertility counseling
and treatment for covered veterans and their spouse).
VA proposes to clarify the statutory definition of the term
delegate to mean any of the following, when acting at the direction or
under the supervision of a licensed VA health care provider: a VA
clinical associate; a VA administrative associate who is involved in
technical troubleshooting, quality control, or quality improvement
activities; scientific investigators who are investigating issues to
support the safe and effective prescribing of controlled substances,
and to support the assessment for safe and effective care delivery to
covered patients; an individual who conducts research with respect to
administering, using in teaching, or chemical analysis a controlled
substance in the course of their research as a VA employee; an
individual who is contracted by VA to provide health care, and is
practicing or researching under their contractual agreement with VA
(other than individuals operating pursuant to VA's authority in 38
U.S.C. 1703); or a VA automated system accessing the national network
of State-based prescription monitoring programs, or any individual
State or regional prescription drug monitoring program. This approach
would allow contractors who are licensed independent health care
providers to access PDMPs at the direction of a VA licensed health care
provider, such as the VA medical facility chief of staff, and to
conduct queries in the same manner as their equivalent VA employee
counterparts.
VA would further clarify that the term clinical associate includes,
but is not limited to, registered nurses, licensed practical nurses,
health care technicians, licensed social workers, researchers, and
psychologists. VA would also clarify that the term administrative
associate includes, but is not limited to, administrative officers,
program analysts, and technical support specialists. Lastly, VA would
clarify that an automated system accessing a PDMP includes, but is not
limited to, automatic queries triggered by the system (such as
scheduled appointments, check-ins to emergency rooms) and queries to
generate a report on a cohort of covered patients who receive
controlled substances (including, but not limited to, patients who are
enrolled into a specific primary care panel or other clinical care
teams or clinics). VA believes that these clarifications would
eliminate confusion as to who VA considers a delegate and thus allows
for better protection of the associate from any possible adverse action
by a State, provided the delegate is acting within the scope of their
VA employment or, if applicable, the scope of their contract.
Section 1730B(c)(3) defines the term licensed health care provider
to mean 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.
VA would clarify in proposed paragraph (a) that a licensed health care
provider means (a) a physician, dentist, nurse practitioner, physician
assistant, or pharmacist employed by VA; or (b) another person
licensed, registered, certified, or otherwise permitted by the United
States or the jurisdiction in which the individual practices to
prescribe or fill a controlled substance in the course of their
practice as a VA employee.
[[Page 29410]]
Prescription Drug Monitoring Program in proposed paragraph (a)
would mean a State or regional prescription drug monitoring program,
including a program approved by the Secretary of Health and Human
Services under section 399O of the Public Health Service Act (42 U.S.C.
280g-3), or an interconnected nation-wide system that facilitates the
transfer of State prescription drug monitoring program data across
State lines. This definition is consistent with the inclusive authority
in section 1730B(a) that extends the protection and requirements of
that subsection to licensed health care providers and delegates
accessing State or regional PDMPs. This definition is also inclusive of
the current definition of the term PDMP in section 1.515(b), which is
based upon the statutory authority set forth in 38 U.S.C. 5701(l)(1)
and 7332(b)(2)(G) to disclose information to such PDMPs. While section
5701(l)(1), section 7332(b)(2)(G), and the current definition of PDMP
in section 1.515(b) explicitly mention State controlled substance
monitoring programs, their references to section 399O of the Public
Health Service Act (42 U.S.C. 280g-3), which specifically provides for
support of States and localities in establishing, implementing,
maintaining, and improving PDMPs, reasonably implies that local
(regional) PDMPs are also intended to be included in the statutory
authority to disclose information to State PDMPs. This interpretation
is also supported by the definition of the term State in section
1730B(c)(5), which specifically includes a political subdivision of a
State. It would not make sense from either a policy or practical
standpoint that Congress intended for VA to request and receive
information from regional PDMPs, but not to share such information with
those same PDMPs. Similarly, whereas statutory authority exists to
request and receive information from, and to disclose information to,
State and regional authorities individually, it logically follows that
such authority would also exist to disclose information to a national
network made up of those programs.
Section 1.515(b) Disclosure to PDMPs
The proposed rulemaking would combine current paragraphs (a) and
(c) and renumber them as new proposed paragraph (b). It would also
replace in the new proposed subsection (b) the permissive nature of
disclosures to State PDMPs with a requirement (replacing may with will)
that VA disclose the specified information to the extent necessary to
prevent misuse and diversion of prescription medicines, reflecting the
statutory amendments to subsection 5701(l)(1) described in the
Background/Statutory Authority section above.
Section 1.515(c) Access to PDMPs
Proposed paragraph (c) would incorporate the authority granted by
and the requirements contained in section 1730B. Proposed paragraph
(c)(1) would restate 38 U.S.C. 1730B(a)(1) in declaring that any
licensed health care provider or delegate is considered an authorized
recipient or user for the purpose of querying and receiving data from
PDMPs to support the safe and effective prescribing of controlled
substances to covered patients.
Proposed paragraph (c)(2) would clarify what VA means by querying
and receiving data. VA would state that querying and receiving data
includes, but is not limited to, viewing, accessing, processing, and
storing the data according to VA's need in a format that is most
appropriate to providing the highest quality clinical care. Different
States have implemented different PDMP protocols for their usual
transactions with non-Federal entities, and VA wants to be inclusive of
all accessing methods. It is worth noting that VA does not manipulate
or change the data in the PDMP database. VA would access the PDMP
databases to obtain the information on the covered patient. Currently,
VA receives a report with the PDMP query results and then documents the
relevant data into its own records per applicable Federal law and
regulations.
Proposed paragraph (c)(3) would state how a licensed health care
provider or delegate would access PDMPs and how the data contained
within PDMPs would be used by VA. VA wants to ensure that VA is as
inclusive as possible with respect to accessing PDMPs for clinical
care. Some methods of accessing PDMPs are more automated and
technologically driven, as opposed to a clinician manually performing a
query. As a result, VA wants to ensure that these options are within
the scope of VA's regulations. VA would state that a licensed health
care provider or delegate can access PDMPs through manual access to the
individual PDMPs or through integrated automated data processing
systems, which include, but are not limited to, health information
exchanges, electronic health records systems, and e-prescribing. Health
information exchanges allow health care providers a secure and sharable
access to a patient's health care information electronically.
Electronic health records are a real-time digital version of a
patient's paper chart that make information available instantly and
securely to authorized users. E-prescribing allows a health care
provider the ability to electronically generate and send a prescription
order directly to a pharmacy. VA would also state that VA information
technology systems may have interoperability with other data systems
and integrated automated queries. These data systems can be
incorporated into clinical workflow to improve the use of such data and
analytics by licensed health care providers and delegates. VA would
clarify that interoperability means: (a) the integration of PDMP data
within electronic health records and health information technology
infrastructure; or (b) linking of a PDMP to other data systems within
the State, including, but not limited to, the State's Medicare and
Medicaid program, workers' compensation programs, medical examiners or
coroners, and any other relevant State, national, or regional database.
VA would also clarify that clinical workflow includes the physical and
mental tasks that are performed in the clinical setting to deliver care
to patients. Improvements to workflow can be achieved through the
integration of automated queries for PDMPs' data and analytics into
health information technologies such as electronic health record
systems, health information exchanges, or pharmacy dispensing software
systems.
VA understands that certain States generally do not allow delegates
to access PDMPs in the same manner as licensed health care providers
when such access is across State lines; however, section 1730B(a)(2)(B)
expressly authorizes VA delegates to access PDMPs in the same manner as
licensed health care providers. For this reason, VA would state in
proposed paragraph (c)(4) that delegates would receive the same access
to shared data to the same extent as licensed health care providers,
including when PDMP data sharing is across State lines. This paragraph
would ensure the protection granted to a delegate by section 1730B from
any adverse action by a State when such delegate is accessing the PDMP
while acting within the scope of the delegate's VA employment or
contractual agreement with VA, if applicable.
Section 1.515(d) Preemption of State law
Proposed paragraph (d) would expressly state the intended
preemptive effect of section 1.515, to ensure that conflicting State
and local laws, rules, regulations, and requirements related to VA
licensed health care providers or
[[Page 29411]]
delegates who query or receive data from PDMPs would have no force or
effect on such providers or delegates. In circumstances where there is
a conflict between Federal and State law, Federal law would prevail in
accordance with Article VI, clause 2 of the U.S. Constitution
(Supremacy Clause). This language has been similarly used in other VA
regulations asserting Federal supremacy where there is a conflict
between State and Federal law. See sections 17.417 and 17.419. VA would
state that notwithstanding any general or specific provision of law,
rule, or regulation of a State, no State may restrict the querying
process or limit the data contained within the query for VA health care
providers or delegates acting in accordance with this section. VA would
also state that no State will 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 queried or received data, or attempted to
query or receive data, from the national network of State-based
prescription drug monitoring programs, or from any individual State or
regional prescription drug monitoring program, under this section. The
Supremacy Clause of the U.S. Constitution bars States and State
officials from penalizing government personnel for performing their
Federal functions, whether through State criminal prosecution, license
revocation proceedings, or civil litigation unless authorized by
Federal law. All suspected improper usage of PDMPs should be reported
to VA for investigation and appropriate action. This paragraph is in
alignment with the preemptive intent of section 1730B.
Executive Order 13132, Federalism
Executive Order 13132 provides the requirements for preemption of
State law when it is expressly stated in rulemaking. While 38 U.S.C.
1730B expressly preempts State law, VA's regulations based on section
1730B must be restricted to the minimum level necessary to achieve the
objectives of the statute pursuant to the regulations that are
promulgated. In this rulemaking, VA licensed health care providers and
their delegates may access State PDMPs irrespective of any State law,
rule, or regulation that would otherwise restrict such access only to
the extent such State laws interfere with the ability of VA health care
providers and delegates to access the State PDMPs. Therefore, VA
believes that the rulemaking is restricted to the minimum level
necessary to achieve the objectives of the Federal statute.
The Executive Order also requires an agency that is publishing a
regulation that preempts State law to follow certain procedures. These
procedures include: that the agency consult with, to the extent
practicable, the appropriate State and local officials in an effort to
avoid conflicts between State law and federally protected interests;
and that the agency provide all affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.
Because this proposed rule would preempt certain State laws, VA
consulted with State officials in compliance with sections 4(d) and
(e), as well as section 6(c) of Executive Order 13132. VA sent a letter
to State PDMP administrators on September 14, 2020. The letter
generally advised the States of VA's proposed approach to implementing
38 U.S.C. 1730B, drawing special attention to: allowing for an
exception to the restriction on the definition of covered patients
concerning patients receiving palliative care or enrolled in hospice
care when clinically appropriate and necessary to ensure the safety of
the patient or to prevent unlawful diversion (an approach that VA has
now reconsidered in favor of pursuing a legislative fix); including a
broad interpretation of receives a prescription within the definition
of covered patients; and including local, municipal, and regional PDMPs
within the definition of State PDMPs. VA received two comments in
response to this letter.
The Commonwealth of Virginia Department of Health Professions
responded to VA's letter on September 29, 2020. The commenter responded
to the four key elements in VA's letter. First, the commenter stated
that Virginia's PDMP does not restrict the use of PDMP by health care
providers treating or dispensing to patients in palliative care or
enrolled in hospice. The commenter added that they believe that access
to PDMP information for all patient types is essential so health care
providers can make the most informed clinical treatment/dispensing
decision possible for their patients. Virginia's PDMP supports allowing
for an exception to the restriction on the definition of covered
patients.
Second, the commenter stated that Virginia's PDMP does not restrict
the use of the PDMP by health care providers who are not prescribing a
controlled substance. The commenter cited the State laws pertaining to
the requirements of the prescriber and the requirements for the
dispenser and supported the allowing for a broad interpretation of
receives a prescription within the definition of covered patient.
Third, the commenter indicated that Virginia's PDMP is aware that
Missouri does not have a statewide PDMP, but a cooperative collection
of cities and counties has created a Prescription Monitoring Program
(PMP), which covers around 80 percent of patients. VA notes that
Missouri transitioned to a Statewide PDMP in December 2023. The
commenter added that Virginia's PDMP supports including local/
municipal/regional PDMPs within the definition of state PDMPs.
Lastly, the commenter stated that Virginia's PDMP has the ability
to cover costs associated with VHA facilities connecting to Virginia's
PDMP and granting access to authorized health care providers. Also,
Virginia's PMP vendor, Appriss Health, (now Bamboo Health) reports
there is no additional cost to the State for this implementation.
VA also received a letter from the State of Hawaii Department of
Public Safety on October 13, 2020. The commenter was in support of
increasing access and usage of Hawaii[revaps]s PDMP information because
it is an effective tool towards addressing the nationwide opioid
epidemic. However, the commenter had two concerns. The commenter's
first concern was that although they appreciate the importance of
protecting the privacy of the prescription information contained in the
Hawaii PDMP, any effort to mandate that Hawaii's PDMP information be
shared with VA should include safeguards to protect confidential
medical information and allow for data to be shared only for VA's
official purposes. The commenter stressed that Hawaii[revaps]s
confidential PDMP information must not be shared by VA with other
entities.
VA agrees with the commenter in that the confidential medical
information contained in the PDMP needs to be safeguarded. Federal law
and regulations require confidentiality and security of any such
records. The Privacy Act (PA) (5 U.S.C. 552a), 38 U.S.C. 5701, and the
Health Insurance Portability and Accountability Act (HIPAA) Privacy and
Security Rules (45 CFR part 160 and subparts A, C, and E of Part 164),
are applicable. Additionally, 38 U.S.C. 5705 and 7332 would protect
information that falls within their purview. VA will continue to abide
by these Federal laws and regulations to continue to protect the
privacy of veterans' medical information. VA will only share such
information as authorized by those laws and regulations.
[[Page 29412]]
The commenter's second concern was regarding the potential costs
that the State Narcotics Enforcement Division (NED) may incur to make
the required connections between the Hawaii PDMP and VA, especially
given the drastic budget crisis facing Hawaii's Department of Public
Safety. The commenter added that VA's letter does not describe what the
potential costs might be and that VA's independent efforts may create
an unfunded mandate that the State NED may incur as a one-time, or
worse yet, an ongoing, recurring cost that cannot be absorbed by their
agency.
VA agrees that States could incur IT development and connection
costs associated with connecting to VA if they were not previously
using PMP InterConnect. However, according to Appriss Health, Hawaii is
currently connected to the system known as PMP InterConnect, and there
are no costs to the State so long as it maintains connectivity to PMP
InterConnect. PMP InterConnect is provided by the National Association
of Boards of Pharmacy/Appriss Health at no cost to the State.
Therefore, it is anticipated that Hawaii will incur no additional cost,
as it is already a member of the required network.
In addition, VA met with 82 of the State PDMP administrators and
the Technical Training and Assistance Center to address both outgoing
PDMP data from VA to the States and the VA new query access. Many of
the questions presented at the meeting were regarding VA delegate
access to the PDMP. Because VA received so many questions regarding
delegates and the related definitions, VA has provided a comprehensive
definition in this rulemaking that would clearly state who VA would
consider a delegate for purposes of querying the PDMP.
Another question posed was whether the VA provider had to register
with the PDMP of the State where they are practicing. VA notes that VHA
Directive 1306 requires VA users to register with the PDMP of the State
in which their VA medical facility (or more specifically where their
assigned Veterans Health Information Systems and Technology
Architecture (VistA) division) is located and to remain active within
that State.
Executive Orders 12866, 13563, and 14192
VA examined the impact of this rulemaking as required by Executive
Orders 12866 (Sept. 30, 1993) and 13563 (Jan. 18, 2011), which direct
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits. The Office of Information and
Regulatory Affairs has determined that this rulemaking is not a
significant regulatory action under Executive Order 12866, as
supplemented by Executive Order 13563. This proposed rule is expected
to be an Executive Order 14192 deregulatory action.
Economic Impact: The proposed amendments clarify statutory
definitions and ensure VA health care providers and delegates can query
PDMPs nationwide regardless of State restrictions. The proposed
amendments also require disclosure of specified information to PDMPs to
prevent misuse and diversion of controlled substances. The rule imposes
no new costs or transfers. Qualitative benefits resulting from this
rule include reductions in administrative burden through automating
PDMP queries and enhancements in clinical decision-making for veteran
care.
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. The provisions associated with this rulemaking are not
processed by any other entities outside of VA. Therefore, pursuant to 5
U.S.C. 605(b), this rulemaking would be exempt from the initial and
final regulatory flexibility analysis requirements of 5 U.S.C. 603 and
604.
Unfunded Mandates
This proposed rule would not result in the expenditure by State,
local, and Tribal governments, in the aggregate, or by the private
sector, of $100 million or more (adjusted annually for inflation) in
any one year.
Paperwork Reduction Act
This proposed rule contains no provisions constituting a collection
of information under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
List of Subjects in 38 CFR Part 1
Administrative practice and procedure, Archives and records,
Cemeteries, Claims, Courts, Crime, Flags, Freedom of information,
Government contracts, Government employees, Government property,
Infants and children, Inventions and patents, Parking penalties,
Privacy reporting and recordkeeping requirements, Seals and insignia,
Security measures, Wages.
Signing Authority
Douglas A. Collins, Secretary of Veterans Affairs, approved this
document on April 21, 2026, and authorized the undersigned to sign and
submit the document to the Office of the Federal Register for
publication electronically as an official document of the Department of
Veterans Affairs.
Gabriela DeCuir,
Alternate Federal Register Liaison Officer, Department of Veterans
Affairs.
For the reasons set forth in the preamble, the Department of
Veterans Affairs proposes to amend 38 CFR part 1 as set forth below:
PART 1--GENERAL PROVISIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
Section 1.515 is also issued under 38 U.S.C. 1730B, 5701, and
7332.
* * * * *
Sec. 1.515 [Amended]
0
2. Revise and republish section 1.515.
Section 1.515 Disclosure of Information to and Querying of State
Prescription Drug Monitoring Programs
(a) Definitions. The following definitions apply to this section.
Controlled substance means any substance identified in 21 CFR part
1308 as a schedule II, III, IV, or V controlled substance.
Covered individual has the same meaning as defined in 38 U.S.C.
5701(l)(2).
Covered patient includes a patient who is prescribed, is dispensed,
or receives a prescription for a controlled substance, or is being
considered for a prescription of a controlled substance by a licensed
health care provider, when their care satisfies the additional
restrictions in 38 U.S.C. 1730B(b)(2).
Delegate means any of the following, when acting at the direction
or under the supervision of a licensed VA health care provider:
(a) A VA clinical associate (including, but not limited to,
registered nurses, licensed practical nurses, health care technicians,
licensed social workers, and psychologists);
(b) A VA administrative associate (including, but not limited to,
administrative officers, program analysts, and technical support
specialists);
(c) Scientific investigators who are investigating issues to
support the safe and effective prescribing of controlled
[[Page 29413]]
substances, and to support the assessment for safe and effective care
delivery to covered patients (unless the investigator is a licensed
health care provider, as defined in this regulation);
(d) An individual who conducts research with respect to
administering, using in teaching, or chemical analysis a controlled
substance in the course of their research as a VA employee (unless the
researcher is a licensed health care provider, as defined in this
regulation);
(e) An individual who is contracted by VA to provide health care
and is practicing or researching under their contractual agreement with
VA. This provision does not include individuals with whom VA contracts
directly or indirectly pursuant to 38 U.S.C. 1703; or
(f) A VA automated system accessing a PDMP, including, but not
limited to, automatic queries triggered by the system (e.g., scheduled
appointments, check-ins to emergency rooms) and queries to generate a
report on a cohort of covered patients who receive controlled
substances (including, but not limited to, patients who are enrolled in
a specific primary care panel or other clinical care teams or clinics).
Licensed health care provider means:
(a) A physician, dentist, nurse practitioner, physician assistant,
or pharmacist employed by VA; or
(b) Another person licensed, registered, certified, or otherwise
permitted by the United States or the jurisdiction in which the
individual practices to prescribe or fill a controlled substance in the
course of their practice as a VA employee.
Prescription drug monitoring program (PDMP) means a State or
regional prescription drug monitoring program, including a program
approved by the Secretary of Health and Human Services under section
399O of the Public Health Service Act (42 U.S.C. 280g-3), or an
interconnected nation-wide system that facilitates the transfer of
State prescription drug monitoring program data across State lines.
State means a State, as defined in 38 U.S.C. 101(20), or a
political subdivision of a State.
(b) Disclosure to PDMPs. Information covered by section 1.500
through 1.527 of this part will be disclosed to PDMPs, to the extent
necessary to prevent misuse and diversion of prescription medicines,
subject to the limitations set forth in this paragraph (b). Such
information is limited to the following concerning the prescription of
controlled substances:
(1) Demographic information of a covered individual. Examples
include name, address, and telephone number.
(2) Information about the dispensed controlled substances. Examples
include the identification of the substance by a national drug code
number, quantity dispensed, number of refills ordered, whether the
substances were dispensed as a refill of a prescription or as a first-
time request, and date of origin of the prescription.
(3) Prescriber information. Examples include the prescriber's
United States Drug Enforcement Administration-issued identification
number authorizing the individual to prescribe controlled substances
and United States Department of Health and Human Services-issued
National Provider Identifier number.
(c) Access to PDMPs. (1) Any licensed health care provider or
delegate is considered an authorized recipient or user for the purpose
of querying and receiving data from PDMPs to support the safe and
effective prescribing of controlled substances to covered patients.
(2) Querying and receiving data includes, but is not limited to,
viewing, accessing, processing, and storing the data according to VA's
need in a format that is most appropriate to providing the highest
quality clinical care.
(3) A licensed health care provider or delegate can access PDMPs
through manual access to the individual PDMPs or through integrated,
potentially automated, information technology solutions. These include,
but are not limited to, health information exchanges, electronic health
records systems, and e-prescribing. VA information technology systems
may have interoperability with other data systems and integrated
automated queries. These data systems can be incorporated into clinical
workflow to improve the use of such data and analytics by licensed
health care providers and delegates.
(i) Interoperability means:
(A) The integration of PDMP data within electronic health records
and health information technology infrastructure; or
(B) Linking of a PDMP to other data systems within the State,
including, but not limited to, the State's Medicare and Medicaid
program, workers' compensation programs, medical examiners or coroners,
and any other relevant State, national, or regional database.
(ii) Clinical workflow includes the physical and mental tasks that
are performed in the clinical setting to deliver care to patients.
Improvements to workflow can be achieved through the integration of
automated queries for PDMPs' data and analytics into health information
technologies such as electronic health record systems, health
information exchanges, or pharmacy dispensing software systems.
(4) Delegates will receive the same access to shared data as
licensed health care providers, including when PDMP data sharing is
across State lines.
(d) Preemption of State law. To achieve important Federal
interests, including, but not limited to, the ability to query or
receive data from PDMPs, this section, as provided in 38 U.S.C. 1730B,
preempts conflicting State laws relating to health care providers or
delegates when they are querying or receiving data from PDMPs.
Notwithstanding any general or specific provision of law, rule, or
regulation of a State, no State may restrict the querying process or
limit the data contained within the query for VA health care providers
or delegates acting in accordance with this section. Any State law,
rule, regulation or requirement pursuant to such law, is without any
force or effect on, and State governments have no legal authority to
enforce them in relation to, this section or decisions made by VA under
this section. No State will 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 queried or received data, or attempted to
query or receive data, from the national network of State-based
prescription drug monitoring programs, or any individual State or
regional prescription drug monitoring program, under this section.
[FR Doc. 2026-10084 Filed 5-19-26; 8:45 am]
BILLING CODE 8320-01-P
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</html>Indexed from Federal Register on May 20, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.