Rule2025-10435
Reporting to the National Practitioner Data Bank
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
June 11, 2025
Effective
July 11, 2025
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) adopts as final, without changes, a proposed rule to remove its regulations governing the National Practitioner Data Bank (NPDB). Instead, VA will rely on Department of Health and Human Services (HHS) regulations that govern the NPDB, a Memorandum of Understanding (MOU) between VA and HHS, and VA policy and procedures.
Full Text
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<title>Federal Register, Volume 90 Issue 111 (Wednesday, June 11, 2025)</title>
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[Federal Register Volume 90, Number 111 (Wednesday, June 11, 2025)]
[Rules and Regulations]
[Pages 24511-24514]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10435]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 46
RIN 2900-AR83
Reporting to the National Practitioner Data Bank
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) adopts as final,
without changes, a proposed rule to remove its regulations governing
the National Practitioner Data Bank (NPDB). Instead, VA will rely on
Department of Health and Human Services (HHS) regulations that govern
the NPDB, a Memorandum of Understanding (MOU) between VA and HHS, and
VA policy and procedures.
DATES: This rule is effective July 11, 2025.
FOR FURTHER INFORMATION CONTACT: Rhonda Gero, Deputy Director, Adverse
Privileging Actions and SLB/NPDB Reporting, VHA Credentialing and
Privileging Office (17QM6), Office of Quality Management, Department of
Veterans Affairs, 810 Vermont Avenue NW, Washington DC 20420, (413)
557-0854. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION:
I. Background
In a proposed rule published in the Federal Register (FR) on April
3, 2023, VA proposed to remove its NPDB regulations at part 46, title
38 Code of Federal Regulations (CFR) and instead rely on HHS
regulations at 45 CFR part 60 for NPDB reporting, supplemented with an
MOU with HHS and VA policy to address NPDB compliance on issues
involving the delivery of health care by a Federal agency. 88 FR 19581.
VA determined that maintaining its own separate NPDB regulations is
problematic because VA's regulations are not wholly consistent with HHS
regulations. Id. at 19582. VA concluded that removing its regulations
would reduce confusion and increase compliance with NPDB reporting
requirements. Id. at 19583. VA provided a 60-day comment period, which
ended on June 2, 2023. VA received one comment during the comment
period.
II. Public Comment
VA received one comment expressing concerns that the proposed rule
would: (1) create confusion and not increase compliance; (2) reduce due
process protections for VA health care practitioners; and (3)
negatively impact staffing and retention of VA health care
practitioners. While VA is not making any changes to the rule based on
this comment, these concerns are addressed in more detail below.
A. Confusion and Compliance With NPDB
The commenter asserted that the removal of VA's NPDB reporting
regulations would neither decrease confusion nor increase compliance
with NPDB reporting requirements. Specifically, the commenter asserts
that even if VA removes its regulations, VA would still need to have an
MOU with HHS and VA policy in place, to fully implement the applicable
HHS NPDB regulations. Therefore, the commenter argued that removing
VA's NPDB regulations does not reduce the sources of NPDB authority,
and it does not eliminate the need for, or improve the efficiency of,
both an MOU with HHS and VA-specific policy on NPDB reporting. Thus,
the commenter believes that VA would need a compelling reason to remove
its NPDB reporting regulations. VA makes no changes based on this
comment.
As discussed in the proposed rule, certain provisions of the HHS
NPDB regulations conflict with VA's role and responsibility as a
Federal agency. Therefore, an MOU with HHS, as well as, VA internal
policies and procedures, would be necessary to address and avoid such
conflicts. See 48 U.S.C. 11152(b); 88 FR 19582-83. While VA
acknowledges that it will continue to rely on the MOU with HHS and VA
policies and procedures, removing the NPDB regulations help to reduce
the total number of NPDB authorities. VA believes that it is easier to
have one set of regulations (HHS) as opposed to two (HHS and VA) and
that VA can support the HHS regulatory framework through updated VA
policies and an MOU with HHS. The process to update VA's policies and
the MOU is much quicker than the process for updating VA's regulations.
This reduces the potential for confusion or conflict between different
sets of regulations, simplifies the regulatory framework, and allows VA
to implement VA-specific procedures as necessary more efficiently in VA
policies and an MOU. Furthermore, no other Federal agency has its own
set of regulations governing its compliance with the NPDB and simply
use the HHS statutory authority, HHS regulatory authority, MOUs, and
their own policies.
The commenter argued that if HHS amends its regulations to include
requirements applicable to VA, VA could simply update its MOU and
policies. However, this overlooks a crucial point: if VA maintained its
own regulations, it would need to update those regulations first before
updating its policies and MOU to ensure they are consistent with
existing regulations. The process to update regulations is time-
consuming, as it requires VA to develop a proposed rule, publish it for
public comment, and then develop a final rule considering those public
comments, before implementing any changes. As a result, when VA's NPDB
reporting regulations have not been updated to reflect changes in HHS
regulations, VA health care practitioners may be confused about which
NPDB reporting requirements to follow. By removing VA's NPDB
regulations, VA streamlines this process. When HHS updates its
[[Page 24512]]
regulations, VA will only need to update its policies and the MOU,
which can be done more quickly and efficiently than amending
regulations. This approach simplifies the process and reduces the
potential for confusion among VA health care practitioners.
The commenter alleges that since VA will still need to maintain and
update the MOU with HHS and VA policy, it needs a compelling reason to
eliminate its NPDB regulations. However, under the Administrative
Procedures Act (APA), if subjected to judicial review, the Secretary's
decision, will only be reversed if a court finds: (a) it arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with
law; (b) contrary to constitutional right, power, privilege, or
immunity; it was obtained without procedures required by law, rule, or
regulation having been followed; (c) in excess of statutory
jurisdiction, authority, or limitations, or short of statutory right;
or (d) without observance of procedure required by law. 5 U.S.C.
706(1)-(2)(A)-(D).
However, the APA does not require the VA to provide a ``compelling
reason'' for creating, amending, or removing regulations. Instead,
under the APA the VA's decision to remove the regulation must not be
``arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law'' (5 U.S.C. 706(2)(A)). VA believes it has met this
standard by providing a rational basis for removing its NPDB
regulations that is supported by statutory and regulatory authority in
the proposed rule. See 88 FR 19582-83. VA explained that removing these
regulations will reduce confusion, eliminate inconsistencies with HHS
regulations, and allow for more efficient updates to VA's NPDB
reporting practices through policy changes rather than the lengthy
regulatory process.
These reasons establish a rational connection between the facts
(current regulatory inconsistencies and improve inefficiencies) and the
chosen action (removing VA's separate NPDB regulations). Therefore, VA
maintains that it has provided sufficient justification for this change
under the applicable legal standard. VA also reiterates that other
agencies, such a Department of Defense, similarly have chosen to have a
MOU with HHS and internal policy; it does not maintain its own section
of regulations for the NPDB. 88 FR 19583. The governing statutory
authority for the NPDB does not require that Federal agencies create
and maintain a separate set of regulations, but only that they enter
into a MOU with HHS.
The commenter further claimed that VA did not provide evidence of
confusion or conflicting language between HHS and VA NPDB reporting
regulations, and the commenter claimed that removal of VA's NPDB
reporting regulations would thus be arbitrary and capricious.
Contrary to the commenter's assertion that we did not provide
evidence of confusing or conflicting language between HHS and VA NPDB
reporting regulations, we stated in the proposed rule that VA's NPDB
regulations are not comprehensive and do not encompass all of VA's
required and permissive reporting requirements; thus, it is not always
clear to VA's health care professionals which requirements are
applicable. 88 FR 19582. We explained that VA's NPDB regulations at 38
CFR part 46 do not explicitly address the reporting requirements of
exclusions from participation in Federal or State health care programs
and other adjudicated actions or decisions as required in 45 CFR 60.15
and 60.16 (Id).
Additionally, the definitions found at 38 CFR 46.1 are not wholly
consistent with those found in 45 CFR 60.3. See 88 FR 19582-19583.
Further, VA regulations only permit reporting of adverse actions
against physicians and dentists (38 CFR 46.12), while HHS additionally
authorizes voluntary reporting of other licensed health care
practitioners (45 CFR 60.12(a)(2)). Id. It is unclear as to whether VA
could voluntarily report these other licensed health care
practitioners. because, while authorized by HHS, it is not in VA's
governing regulations, which may indicate VA did not exercise its
authority to report and therefore cannot report them and would need to
update the regulations if it wanted to report them. Thus, VA determined
removing VA's NDPB reporting regulations and exclusively following HHS
NPDB reporting regulations will directly reduce confusion and resolve
inconsistencies between VA and HHS requirements moving forward.
The commenter claimed it would be arbitrary and capricious for VA
to eliminate the NPDB regulations on the conclusory assertion that
there is confusion. VA disagrees. Pursuant to 5 U.S.C. 706, VA is
required to provide a rational basis. As explained above and further in
the proposed rule, VA provided a rational basis for proposing to remove
its NPDB regulations, which it incorporates in this final rule. See 88
FR 19582-83. VA also conducted extensive consultations with HHS and
concluded that consolidation into one regulatory authority would reduce
confusion and inconsistencies. See 88 FR 19582. VA reiterates that
removing its NPDB reporting regulations brings VA in line with other
Federal health agencies, eliminates direct conflicts or consistencies
with HHS rules, and simplifies NPDB authority for VA staff. See 88 FR
19583.
The commenter further opined that instead of removing its NPDB
reporting regulations, VA should address noncompliance of NPDB
reporting requirements by updating VA's policies to ensure NPDB
reporting requirements are clear and fill any gaps of applicable NPDB
reporting requirements, based on a 2022 VA Office of Inspector General
(OIG) report. See VA OIG Noncompliant and Deficient Processes and
Oversight of State Licensing Board and National Practitioner Databank
Reporting Policies by VA Medical Facilities, Report #20-00827-126,
April 7, 2022.
VA acknowledges that OIG did not conclude that VA's NPDB reporting
regulations were a source of confusion and/or cause of the noncompliant
and deficient reporting processes. However, VA examined its overall
NPDB reporting practices and determined, in consultation with HHS, that
its NPDB regulations should be removed and that VA should instead rely
on HHS NPDB reporting regulations, supplemented by an MOU with HHS and
VA policy and procedures, to address the reporting deficiencies. See 88
FR 19582. It must be noted that removing its NPDB regulation is only
part of a larger plan to meet OIG's recommendations. VA is updating VHA
Directive 1100.17, National Practitioner Data Bank Reports (December
28, 2009), updating the MOU with HHS, and is enhancing its oversight
and training. Thus, removal of VA's reporting regulations will
complement the other NPDB compliance efforts VA is undertaking.
B. Due Process Protections for VA Health Care Practitioners
The commenter alleged that removing VA's NPDB reporting regulations
will reduce due process protections for VA health care practitioners,
listing three examples. First, the commenter stated that VA's current
regulations require that when reviewing malpractice claims, at least
one member of the medical malpractice review panel must be from the
same profession as the practitioner under review, whereas HHS
regulations do not have such a requirement. Second, the commenter
stated that under VA regulations the medical center director is
responsible for submitting reports to the NPDB, whereas the HHS
regulations permit health care practitioners to voluntarily report
their peers to the NPDB. Third, the
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commenter stated that the HHS regulations require all payments for
medical malpractice be reported to the NPDB, whereas VA's review panels
only report after the majority of the VA review panel determine that
the payment was related to substandard care, professional incompetence,
or professional misconduct.
Regarding the first concern, VA clarified in the proposed rule that
removing its NPDB regulations will not alter its processes for
reviewing and reporting malpractice payments. See 88 FR 19583.
Specifically, VHA Directive 1100.17, National Practitioner Data Bank
Reports, which explains that ``all panels must include a member of the
same profession and specialty, as appropriate, of the individual being
reviewed'' would remain status quo. (VHA Directive 1100.17; Para
8.(g)(1)) This approach preserves the integrity of the review process
while streamlining regulatory requirements.
With respect to the second concern related to voluntary reporting,
VA clarifies that 45 CFR 60.12(a)(2) permits health care entities to
voluntarily report adverse privileging actions against ``other licensed
health care practitioners'' but requires health care entities to report
adverse privileging actions taken against physicians and dentists. 45
CFR 60.12(a)(1) and (2). There is nothing in the regulation that
requires or permits a ``peer'' to report a provider subjected to an
adverse privileging action.
The commenter expressed concern that following HHS regulations
would require the VA to depart from its past practice of reporting
payments after a majority of the review panel determines that payment
was related to substandard care, professional incompetence, or
professional misconduct, and now report ``frivolous complaints'' or
``nuisance settlement payments''. However, VA disagrees with the
commenter's position. As stated previously, VHA Handbook 1100.17, which
explains that a malpractice payment is only reported after a majority
of the review panel determines that the payment was ``related to
substandard care, professional incompetence, or professional
misconduct'' on the part of the provider, would continue to apply to
situations involving medical malpractice payments. (VHA Handbook; Para;
8 (i.)(1)) Note: If any changes to VA's policy regarding NPDB reporting
policy were proposed in the future that would impact the terms and
conditions of hybrid title 38 bargaining unit employees, such proposed
changes would be subject to the applicable collective bargaining rules
and regulations. Specifically, the VA is required to provide notice to
the applicable Union(s) and/or bargain over their impact and
implementation.
C. Staffing and Retention
The commenter raised concerns about the potential impact of
removing VA's NPDB reporting regulations on staffing, retention, and
patient satisfaction. The commenter stated that by eliminating VA's
NPDB reporting regulations, VA is ``eviscerating'' due process rights
and safeguards, which will result in voluntary separations and
difficulties in hiring. The commenter provided specific information
about VA staffing shortages and argued that these shortages could lead
to more patient complaints and settlements even when practitioners are
not at fault, which could result in increased reporting to the NPDB.
The commenter also raised concerns that VA's current NPDB reporting
requirements and the due process protections attract health care
practitioners to work at VA. The commenter opined that the downstream
result is the exacerbation of a chronic recruitment and retention
problem for VA, both because fewer practitioners will want to work for
VA and because more practitioners will have been reported to NPDB with
fewer due process protections. We make no changes based on this
comment.
VA does not believe removing VA regulations will impact staffing
and retention because the procedures and safeguards around NPDB
reporting for VA that the commenter discussed will continue to be
followed pursuant to VHA Directive 1100.17 and the MOU with HHS. As
mentioned above, although the VA regulations will be removed, the VA
requirements for reporting under HHS NPDB regulations will be retained
in VA policy and the MOU with HHS. See 88 FR 19582. Note: If any
changes to VA's policy regarding NPDB reporting policy were proposed in
the future that would impact the terms and conditions of hybrid title
38 bargaining unit employees, such proposed changes would be subject to
the applicable collective bargaining rules and regulations.
Specifically, the VA is required to provide notice to the applicable
Union(s) and/or bargain over their impact and implementation.
Therefore, as there will be no changes regarding the prohibition of
peer to peer reporting, the composition of the review panel, or how
many people in the review panel need to agree to report the
practitioner to the NPDB, VA does not believe there will be an increase
in frivolous reporting to the NPDB and also believes that prospective
employees would still be attracted to VA for its due process
protections at the same level as they were before the removal of the
regulations.
The commenter also claimed that the proposed changes undermine the
purpose of 38 U.S.C. and that VA is ceding its authority to HHS. VA
clarifies that it is not ceding its authority to HHS but is required by
42 U.S.C. 11101 et seq. to comply with applicable HHS regulations while
retaining the flexibility to set reporting processes through internal
policy and the MOU with HHS. VA's proposal is consistent with how other
Federal agencies comply with their statutory and regulatory obligations
to comply with the HHS NPDB statutes and regulations. See 88 FR 19583.
Based on the rationale set forth in the proposed rule and in this
final rule, VA is adopting the proposed rule without changes.
Executive Orders 12866, 13563, and 14192
Executive Order 12866 (Regulatory Planning and Review) directs
agencies to assess the costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, and other advantages;
distributive impacts; and equity). Executive Order 13563 (Improving
Regulation and Regulatory Review) emphasizes the importance of
quantifying both costs and benefits, reducing costs, harmonizing rules,
and promoting flexibility. Executive Order 14192 (Unleashing Prosperity
Through Deregulation) promotes prudent financial management and
alleviates unnecessary regulatory burdens. The Office of Information
and Regulatory Affairs has determined that this rulemaking is not a
significant regulatory action under Executive Order 12866. This rule is
not an Executive Order 14192 regulatory action because this rule is not
significant under Executive Order 12866. The Regulatory Impact Analysis
associated with this rulemaking can be found as a supporting document
at <a href="http://www.regulations.gov">www.regulations.gov</a>.
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule will 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). This final rule will
[[Page 24514]]
only affect individuals who are VA employees or independent contractors
acting on behalf of VA and will not directly affect small entities.
Therefore, pursuant to 5 U.S.C. 605(b), the initial and final
regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do
not apply.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires that agencies
prepare an assessment of anticipated costs and benefits before issuing
any rule that may 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. 2
U.S.C. 1532. This final rule will have no such effect on State, local,
and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
Congressional Review Act
Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C.
801 et seq.), the Office of Information and Regulatory Affairs
designated this rule as not satisfying the criteria under 5 U.S.C.
804(2).
List of Subjects in 38 CFR Part 46
Health professions, Reporting and recordkeeping requirement.
Signing Authority
Douglas A. Collins, Secretary of Veterans Affairs, approved and
signed this document on June 3, 2025, 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.
Taylor N. Mattson,
Alternate Federal Register Liaison Officer, Department of Veterans
Affairs.
PART 46--[REMOVED AND RESERVED]
0
For the reasons stated in the preamble, and under the authority of 38
U.S.C. 501, the Department of Veterans Affairs removes and reserves 38
CFR part 46.
[FR Doc. 2025-10435 Filed 6-10-25; 8:45 am]
BILLING CODE 8320-01-P
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