Federal Register Extracts

Agency: "Department of Veterans Affairs."

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. 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/

FOOTNOTE 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). END FOOTNOTE

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.

--This is a summary of a Federal Register article originally published on the page number listed below--

Proposed rule.

CFR Part: "38 CFR Part 46"

RIN Number: "RIN 2900-AR83"

Citation: "88 FR 19581"

Federal Register Page Number: "19581"

"Proposed Rules"