90 FR 111 pgs. 24511-24514 - Reporting to the National Practitioner Data Bank
Type: RULEVolume: 90Number: 111Pages: 24511 - 24514
Pages: 24511, 24512, 24513, 24514FR document: [FR Doc. 2025-10435 Filed 6-10-25; 8:45 am]
Agency: Veterans Affairs Department
Official PDF Version: PDF Version
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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.
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.
[top] 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
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
[top] 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
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 www.regulations.gov.
Regulatory Flexibility Act
[top] 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
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]
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]
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