[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Proposed Rules]
[Pages 19581-19583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06811]


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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: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes 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. This change will allow VA to more 
easily and effectively comply with HHS rules governing the NPDB.

DATES: Comments must be received on or before June 2, 2023.

ADDRESSES: Comments may be submitted through www.Regulations.gov. 
Except as provided below, comments received before the close of the 
comment period will be available at www.regulations.gov for public 
viewing, inspection, or copying, including any personally identifiable 
or confidential business information that is included in a comment. We 
post the comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. VA will not post on 
Regulations.gov public comments that make threats to individuals or 
institutions or suggest that the commenter will take actions to harm 
the individual. VA encourages individuals not to submit duplicative 
comments. We will post acceptable comments from multiple unique 
commenters even if the content is identical or nearly identical to 
other comments. Any public comment received after the comment period's 
closing date is considered late and will not be considered in the final 
rulemaking.

FOR FURTHER INFORMATION CONTACT: Marianne Chick, MHA, Director, VHA 
Medical Staff Affairs (10E1F), Office of Quality Management, Department 
of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, Phone 
(919) 474-3937. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: 

I. Background on the National Practitioner Data Bank

Health Care Quality Improvement Act of 1986 and Implementing 
Regulations

    The National Practitioner Data Bank (NPDB) was established by the 
Health Care Quality Improvement Act of 1986 (HCQIA), as amended (42 
United States Code (U.S.C.) 11101 et seq.). The NPDB was developed by 
the U.S. Department of Health and Human Services (HHS), Health 
Resources and Services Administration (HRSA), and Bureau of Health 
Professions (BHPr). The NPDB is a web-based repository of reports 
containing information on medical malpractice payments and certain 
adverse actions taken against health care practitioners, providers, and 
suppliers. It is a workforce tool that assists in promoting quality 
health care and deterring fraud and abuse within health care delivery 
systems. It prevents health care practitioners, providers, and 
suppliers from moving from one State to another without disclosure or 
discovery of previous damaging actions or incompetent performance.
    The HCQIA authorizes the NPDB to collect reports of adverse 
licensure actions against physicians, dentists, and other licensed 
independent practitioners (including revocations, suspensions, 
reprimands, censures, probations, and surrenders); adverse clinical 
privileges actions; adverse professional society membership actions 
against physicians and dentists; Drug Enforcement Administration (DEA) 
certification actions; Medicare/Medicaid exclusions; and medical 
malpractice payments (including settlement of medical malpractice 
claims) made for the benefit of any health care practitioner. 
Information under the HCQIA is reported by medical malpractice payers, 
State medical and dental boards, professional societies with formal 
peer review, and hospitals and other health care entities (such as 
health maintenance organizations). The NPDB reports are confidential 
and therefore, not accessible by the public. Rather, health care 
entities that have formal peer review processes and provide health care 
services, State medical or dental boards, and other health care 
practitioner State boards have access to this data system.

[[Page 19582]]

Additionally, individual practitioners may conduct a self-query.
    On October 17, 1989, HHS finalized and published the NPDB 
regulations at 45 CFR part 60. See 54 FR 42722. Those regulations set 
forth the criteria and procedures for information to be collected in 
and released from the NPDB, in accordance with the requirements of 
HCQIA. The NPDB began collecting reports on September 1,1990. See 55 FR 
31239 (August 1, 1990).

VA-HHS Memorandum of Understanding (MOU) and VA Regulations

    VA and HHS entered into a MOU as required by 42 U.S.C. 11152(b). 
This MOU was necessary because HCQIA Title IV did not include federal 
agencies in its reporting and querying requirements. Moreover, as a 
Federal agency, VA is unable to comply with certain provisions of the 
HHS regulations regarding reporting procedures and requirements for 
reporting medical malpractice payments and clinical privileges because 
certain provisions are governed by the MOU as well as by VA specific 
policies and procedures.
    For instance, consistent with the Federal Tort Claims Act (28 
U.S.C. 1346(b), 2671-2680), Federal District Courts have exclusive 
jurisdiction over civil actions on claims against the United States, 
for money damages, due to personal injury or death caused by the 
negligent or wrongful act or omission of any employee of the Government 
while acting within the scope of their office or employment, under 
circumstances where the United States, if a private person, would be 
liable to the claimant in accordance with the law of the place where 
the act or omission occurred. This includes medical malpractice claims 
filed against a VA medical facility or a VA health care provider. The 
beneficiary cannot sue the facility or the provider directly but must 
file the claim against the United States Government. The Federal 
government assumes responsibility for costs related to a claim 
resulting from the performance of a medical, surgical, dental, or 
related function.
    Therefore, the MOU addresses reporting payments made by VA for 
medical malpractice claims, including settlements, made on behalf of a 
VA health care provider. The MOU includes an agreement that VA will 
identify the licensed practitioner for whose benefit the payment was 
made. The MOU also addresses VA's obligation to report: (1) certain 
actions to State licensing boards; (2) adverse clinical privileging 
actions against all privileged providers; and (3) actions under Section 
1128E of the Social Security Act, which is described in more detail 
below.
    On October 28, 1991, VA published regulations at 38 CFR part 46 to 
formalize and interpret the provisions of the MOU. 56 FR 55462. On May 
23, 2002, VA subsequently amended this regulation. 67 FR 19678. This 
amendment reflected changes in VA's internal processes.

Section 1921 of the Social Security Act and Implementing Regulations

    Section 1921 of the Social Security Act (42 U.S.C. 1396r-2), as 
amended by section 5(b) of the Medicare and Medicaid Patient and 
Program Protection Act of 1987, and the Omnibus Budget Reconciliation 
Act of 1990, Public Law 101-508, expanded the State requirements under 
the NPDB. Each State is required to adopt a system of reporting to the 
Secretary of HHS for the following actions: (1) adverse licensure or 
certification actions taken against health care practitioners, health 
care entities, providers, and suppliers; and (2) certain final adverse 
actions taken by State law and fraud enforcement agencies against 
health care practitioners, providers, and suppliers. On January 28, 
2010, HHS updated its NPDB regulations to comply with Section 1921 of 
the Social Security Act. See 75 FR 4656. The NPDB began collecting and 
disclosing section 1921 information on March 1, 2010. 75 FR 4656 
(January 28, 2010).
    In 1996, the Health Insurance Portability and Accountability Act of 
1996, (42 U.S.C. 1320a-7e) added section 1128E to the Social Security 
Act, which directed HHS to establish and maintain a national health 
care fraud and abuse data collection program for the reporting and 
disclosing of certain final adverse actions taken by Federal agencies 
and health plans against health care practitioners, providers, or 
suppliers. This data was previously collected by the Healthcare 
Integrity and Protection Data Bank (HIPDB). The HIPDB began collecting 
reports in November 1999, but as of May 6, 2013, this collection is now 
included in the NPDB.\1\
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    \1\ Section 6403 of the Patient Protection and Affordable Care 
Act of 2010, Public Law 111-148, amended sections 1921 and 1128E to: 
eliminate duplication between the HIPDB and the NPDB; require the 
Secretary of HHS to establish a transition period of transferring 
data collected in the HIPDB to the NPDB; and cease HIPDB operations. 
Final regulations implementing section 6403 were issued on April 5, 
2013 (78 FR 20473) and May 6, 2013 (78 FR 25858).
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Revisions to 45 CFR 60.30 in 2015

    On April 5, 2015, HHS amended 45 CFR 60.3 to include VA as a 
Federal government agency in NPDB reporting requirements. See 78 FR 
20473, 20485. We note that the recognition of VA as a Federal 
government agency does not preclude the need for an MOU between VA and 
HHS to address circumstances that are not required by the HHS 
regulations as mentioned above.

II. Proposed Removal of 38 CFR Part 46

    VA has determined, in consultation with HHS, that its NPDB 
regulations at 38 CFR part 46 should be removed, and that VA should 
instead rely on HHS regulations at 45 CFR part 60 for NPDB reporting, 
supplemented with a MOU with HHS and VA policy to address NPDB 
compliance on issues involving the delivery of health care by a federal 
agency. VA has determined that maintaining separate NPDB rulemaking is 
problematic. VA's regulations are not comprehensive and therefore, it 
is not always clear to VA health care professionals, which requirements 
are applicable.
    Since 38 CFR part 46 was drafted to formalize the MOU with HHS, it 
did not encompass all of VA's required and permissive reporting 
requirements. For example, additional amendments have been made to the 
HHS NPDB regulations to include additional reporting requirements that 
are applicable to VA such as 45 CFR 60.15 and 60.16 78. FR 20473 (April 
5, 2013). These amendments require the reporting of exclusions from 
participation in Federal or State health care programs and other 
adjudicated actions or decisions. Although required, VA's regulations 
at 38 CFR part 46 do not explicitly address this requirement. Also, 
part 46 definitions at 38 CFR 46.1 are not wholly consistent with those 
found in 45 CFR 60.3. Further, HHS NPDB reporting requirements allow 
for voluntarily reporting of adverse actions taken against clinical 
privileges by other health care practitioners. 45 CFR 60.12(a)(2). 
However, VA did not include this voluntary reporting requirement in its 
regulation which has precluded it from reporting actions by other 
health care practitioners. These inconsistencies create confusion and 
place self-imposed limitations on VA.
    In addition, when HHS amends 45 CFR part 60, VA is not able to 
amend 38 CFR part 46 until after HHS publishes a final rule. VA's NPDB 
regulation could be inconsistent with HHS's for a significant interim 
period. This problem is avoided if VA relies on 45 CFR part 60 as 
guidance on NPDB

[[Page 19583]]

reporting requirements. In addition, 38 CFR part 46 address internal 
agency processes related to VA medical malpractice review panels that 
may be subject to change. Therefore, we believe that it should be 
memorialized in VA policy rather than regulation.
    We note that VA is the only Federal agency providing health care to 
eligible beneficiaries that published regulations on NPDB compliance. 
The Department of Defense has not published regulations on NPDB, but 
instead cites to 45 CFR part 60 as authority and issued agency policy 
to implement the NPDB reporting requirements for the component armed 
services. Likewise, the U.S. Public Health Service and Indian Health 
Service also issued policies implementing the NPDB reporting 
requirements.
    The proposed removal of 38 CFR part 46 will not obviate VA's 
reporting requirements nor will it alter how malpractice is handled for 
VA practitioners. Rather we believe relying on 45 CFR part 60, 
supplemented by an MOU with HHS and VA policy, will reduce confusion 
and allow VA to adhere to all mandatory and permissive reporting 
requirements by eliminating any inconsistency between HHS and VA 
regulations.
    Based on the foregoing rationale, VA proposes removing part 46 and 
marking it as reserved for future use and relying on HHS regulations at 
45 CFR part 60 for NPDB reporting requirements, supplemented by an MOU 
between HHS and VA policy.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 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. 
The Office of Information and Regulatory Affairs has determined that 
this rule is not a significant regulatory action under Executive Oder 
12866. The Regulatory Impact Analysis associated with this rulemaking 
can be found as a supporting document at www.regulations.gov.

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). This proposed rule would 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 proposed rule would have no such effect on State, 
local, and tribal governments, or on the private sector.

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).

Assistance Listing

    The Assistance listing numbers and titles for the programs affected 
by this document are: 64.007, Blind Rehabilitation Centers; 64.008, 
Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 
64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 
64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic 
Appliances; 64.018, Sharing Specialized Medical Resources; 64.019, 
Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans 
Home Based Primary Care; 64.039 CHAMPVA; 64.040 VHA Inpatient Medicine; 
64.041 VHA Outpatient Specialty Care; 64.042 VHA Inpatient Surgery; 
64.043 VHA Mental Health Residential; 64.044 VHA Home Care; 64.045 VHA 
Outpatient Ancillary Services; 64.046 VHA Inpatient Psychiatry; 64.047 
VHA Primary Care; 64.048 VHA Mental Health Clinics; 64.049 VHA 
Community Living Center; and 64.050 VHA Diagnostic Care.

List of Subjects in 38 CFR Part 46

    Health professions, Reporting and recordkeeping requirements.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on March 27, 2023, 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.

Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of General Counsel, Department of Veterans Affairs.

    For the reasons set forth in the preamble, we propose to amend 38 
CFR part 46 as follows:

PART 46--[Removed and Reserved]

0
1. Remove and reserve part 46, consisting of Sec. Sec.  46.1 through 
46.8.

[FR Doc. 2023-06811 Filed 3-31-23; 8:45 am]
BILLING CODE 8320-01-P