Disputes Process Overview - Final.pdf

Dispute Resolution Review Process Overview

The subject of a National Practitioner Data Bank (NPDB) report may dispute the accuracy of the report content and whether the report was submitted in accordance with reporting requirements.

The Secretary of the U.S. Department of Health and Human Services delegates Dispute Resolution Review to the Division of Practitioner Data Bank of the Health Resources and Services Administration.

During the Dispute Resolution Process, the NPDB reviews (1) whether the action is reportable under applicable statutes and regulations and (2) whether the report accurately reflects the reporting entity’s action and reasons for action as stated in the written record. The NPDB cannot make any determinations regarding the underlying merits of the issues raised during the Dispute Resolution Process or substitute its judgment for that of the reporting entity. The Dispute Resolution Process is a fair and transparent process that results in one of the following outcomes:

• If the report is accurate as submitted, it will remain in the NPDB as originally submitted by the reporting entity.

• If the report is inaccurate based on the written record, the NPDB will request that the reporting entity correct the report to accurately reflect the record. When a report is corrected, the original report is removed from the system and replaced with the corrected report.

• If the report is voided, it is retracted in its entirety and it is no longer disclosed to entities querying the practitioner. A report may only be voided when:

o The report was submitted in error;

o The action was not reportable because it did not meet the NPDB reporting requirements; or o The action was overturned on appeal.

More information about the Dispute Resolution Process is available via the NPDB website and Chapter F of the NPDB Guidebook.

Dispute Resolution Review Process Steps *Dispute Resolution Review Process Workflow attached as Appendix I

1. The dispute case is uploaded to the case management system (Tracker) by the NPDB

Operations Support Team. [See Appendix II for sample dispute case documentation.]

2. Tracker notifies the Branch Chief, who assigns the case to a Dispute Resolution Manager

(DRM).

3. Tracker notifies the DRM of the assignment, and the DRM starts the case review.

4. The DRM completes the Request for Information (RFI). Process:

4.1. The DRM reviews the case documents to gather the dispute points and issues raised to https://www.npdb.hrsa.gov/pract/howToDisputeAReport.jsp https://www.npdb.hrsa.gov/guidebook/FOverview.jsp

Dispute Resolution Review Process Workflow help write the RFI. RFIs should be customized to the issues raised in each dispute case.

Some examples of documentation that the NPDB requests in an RFI include but are not limited to a timeline of events, investigation reports, meeting minutes, correspondence, business records, licensing board final orders, medical malpractice claim or complaint, signed settlement agreement and other court filings.

Some dispute cases, such as State Licensure or Certification Action cases, may not require an RFI if sufficient supporting documentation can be accessed through the Board’s publicly available information, or in reconsideration or re-elevation cases where sufficient supporting documentation is already available. In these cases, a note should be added on Tracker noting that an RFI was not needed and why. The case status should then be updated to reflect the actual status of the dispute case (e.g., drafting decision).

4.2. The DRM identifies reporting entity contact & registration status from the disputed report and/or entity profile; the DRM adds notes in Tracker with the contact information, if necessary.

4.3. The DRM adjusts the draft RFI template(s) to fit requirements for the case and obtains review and approval from the Branch Chief, if necessary.

4.4. The DRM sends the RFI, requesting a response within 30 and changes the case status to “RFI” – see sample RFI in Appendix II.

4.5. In Tracker, the DRM uses the “Send SM [Secure Message] to Entity” function to send the RFI to the reporting entity point of contact (POC) which are listed in a drop-down menu. The DRM selects the individuals to send the RFI. The RFI is electronically submitted via secure message to the entity’s inbox connected to the NPDB.

4.6. Tracker displays whether the entity POC has viewed the RFI.

4.7. If a response to the RFI is not received within 30 days, the DRM follows up with the entity POC and others from the reporting entity. If delays persist, or the DRM is unable to reach the POC, the DRM confers with the Branch Chief to determine whether to follow up with a second, or in some cases, a third RFI. The second and third RFIs will document the attempts made by the DRM to reach the POC and to obtain the RFI response information. These attempts will be over the phone or through secure message.

The additional requests will reiterate why a response from the entity is important and essential to receiving a complete record to make a decision in the dispute resolution case.

A 15–30-day extension may be granted on a case-by-case basis.

4.8. When the entity responds to the RFI, Tracker is updated with a case status of “drafting response”.

5. Case analysis and drafting the decision letter:

5.1. The DRM reviews submitted documentation for completeness and updates Tracker noting receipt of the supporting documentation for further review and changes the case status to “drafting decision” - see sample supporting documentation in Appendix II.

5.2. The DRM gathers and reviews the submitted information and conducts the analysis to determine the decision – denial, correction, or void based on the NPDB reporting guidelines.

5.3. The DRM requests additional information from the subject or the entity if necessary.

5.4. The DRM drafts the decision letter based on analysis of the supporting documentation and NPDB regulations.

6. Initial Decision Letter Review:

6.1. The DRM sends the draft decision letter for peer review and changes the case status to “peer review”.

6.2. The peer reviewer reviews the draft decision letter and case documentation, uploads their feedback as applicable.

6.3. The DRM incorporates the peer reviewer’s feedback as applicable and changes the case status back to “drafting decision”. The DRM retains all the versions until the case closes.

6.4. The DRM sends the revised draft letter to the Branch Chief for review and changes the case status to “manager review”.

6.5. The Branch Chief reviews the draft decision letter, uploads their feedback as applicable, and Tracker automatically changes the case status to “drafting decision.”

6.6. The DRM incorporates the Branch Chief or other leadership reviewer’s feedback, as applicable and resends the revised version for review and signature (initial cases).

At any given time, the DRM may need to consult with the Office of the General Counsel (OGC) on complex issues. A few examples of complex issues include, but are not limited to when the report in question does not reflect the record and a void may be appropriate, the action taken by the entity may not have been reportable under NPDB regulations, cases where the entity is missing documentation or a case where there are complex factual components involved. When the request is sent to OGC, the DRM changes the case status to “OGC review”.

7 Reconsideration Decision Letter Review:

Subjects of reports may request reconsideration of dispute resolution decisions. Subjects of reports should be specific about any new information that was unavailable to them at the time of the review, as well as the issue(s) they believe were inappropriately considered during the review. Either the previous decision will be affirmed, or a revised final decision will be issued.

The procedures of a reconsideration case are as follows:

7.1 The subject’s written reconsideration request and supporting documentation is uploaded to Tracker by the NPDB Operations Support Team.

7.2 After review of the subject’s reconsideration documentation, the DRM will determine whether another RFI is appropriate for the case.

7.3 If another RFI needs to be sent to the reporting entity, the DRM will follow the same steps as listed above.

7.4 Once the DRM receives additional documentation from the entity or determines that no additional documentation is needed in order to write the reconsideration decision, the DRM proceeds with drafting the reconsideration decision, and sends it for peer and Branch Chief review as listed above.

7.5 After incorporating the feedback from the peer reviewer and Branch Chief, as applicable, the draft decision letter is sent to the Deputy Director (or the Director depending on who signed the initial decision letter) for review.

7.6 The DRM incorporates the Deputy Director’s feedback, as applicable and resends the revised version for review and signature (reconsideration cases).

8. Decision letter is complete:

When the decision letter review is completed, the approved letter is e-signed and uploaded to Tracker by the Branch Chief, Deputy Director, or Director depending on whether it is an initial case or a reconsideration case and who was the last signatory– see sample Decision Letter in Appendix II.

8.1 Denial Decision: In the case of a denial decision, the DRM attaches the signed letter and changes the case status from “Manager Review” to “Case Decision – Denial” which triggers a notification to the NPDB Operations Support Team that the case is ready to be closed.

8.2 Correction Decision: In the case where the DRM determines that a report does not accurately reflect the record, the DRM drafts a correction letter and sends it to the reporting entity via the NPDB secure messaging system. The reporting entity is given 30-days to make the correction or submit supporting documentation of why the report is accurate as submitted. The DRM may make this decision on their own for simple corrections, however, it is a best practice to seek peer and manager review of the correction letter, especially if it involves complex or substantive changes.

The subject of the report is also copied on the letter. A correction report corrects an error or omission in a previously submitted report by replacing it. The reporting entity must submit a correction report as soon as possible after the discovery of an error or omission in a report. The reporting entity may submit a correction report as often as necessary.

When the NPDB processes a correction report, the NPDB provides the reporting entity with a copy of the correction report. In addition, the NPDB sends a notification to the subject of the report and a copy to all queriers who received the previous version of the report within the past 3 years. The reporting entity and the subject of the report should review the report information to ensure that it is accurate, and past queriers should note the changed report.

When the report is corrected, the system will change the case status to “Case Decision – Correction.” If the reporting entity refuses to correct the report, the DRM will send a final follow up letter to the entity advising that the entity has 30 days to correct the report or to provide previously unsubmitted justification of why it should not be corrected. The letter will advise that the report will be corrected by HHS after this timeframe, if no response or an inadequate response is received within the 30 days.

If appropriate, and the subject wishes to continue the dispute resolution review, the corrected report will be re-elevated by the NPDB Operations Support Team to Tracker and re-assigned to the DRM who was handling the case. This procedure can be repeated as many times as the report is corrected in cases where the subject wants to continue the https://www.npdb.hrsa.gov/guidebook/ESubmittingReports.jsp#Correction review. The aforementioned procedural steps apply once the case is re-elevated after a correction.

8.3 Void Decision: The DRM may determine that a report does not meet the NPDB reporting requirements, in this case, a void may be appropriate. In order to move forward with a void decision, the DRM must consult OGC and the Branch Chief, peer review is also recommended.

The DRM drafts a void letter after consultation with the peers, Branch Chief, and OGC.

The Void letter is e-signed by the Branch Chief and sent to the reporting entity via the NPDB secure messaging system with a 30-day deadline to either void the report or provide a written rationale with supporting documentation of why the report should not be voided.

The subject of the report is also copied on the letter. A void report, also referred to as a void, is the withdrawal of a report in its entirety. When the reporting entity voids a report, the report is removed from the disclosable record of the subject of the report. A reporting entity may void a report at any time. The three reasons for voiding a report are:

• The report was submitted in error;

• The action was not reportable because it did not meet NPDB reporting requirements; or

• The action was overturned on appeal.

When the NPDB processes a Void, the NPDB provides the reporting entity with a Report Void Confirmation. The NPDB also sends a notification to the subject and to all queriers who received the previous version of the report within the past 3 years. All queriers who received the previous version of the report within the past 3 years are directed to destroy the prior report and any copies of it. The reporting entity and the subject of the report should review the information to ensure that the intended report was voided, and past queriers should note that the report was voided.

In some cases, a report will be voided in order to correct an error and a new, related report will be submitted by the reporting entity. If the subject wishes to continue the dispute resolution review, the new report will be re-elevated by the NPDB Operations Support Team to Tracker and re-assigned to the DRM who was handling the previous case. The aforementioned procedural steps apply once the case is re-elevated after a void of this type.

If the reporting entity refuses to void the report, the DRM will send a final follow up letter to the entity advising that the entity has 30 days to void the report or to provide previously unsubmitted justification of why it should not be voided. The letter will advise that the report will be voided by HHS after this timeframe, if no response or an inadequate response is received within the 30 days.

9 The NPDB Operations Support Team conducts the following steps to close the case:

https://www.npdb.hrsa.gov/guidebook/ESubmittingReports.jsp#Correction

9.1 The Operations Support Team reviews the decision letter, checking for potential errors or other items that require follow up with the DRM.

9.2 The Operations Support Team adds Secretary Statement to the report based upon what is written in the decision letter. The Secretary Statement is a concise summary of the outcome of the dispute resolution decision and is added to the report itself by the Operations Support Team. There are specific statements that need to be added based on the type of report (clinical privileges, state licensure or certification, medical malpractice payment report, etc.…). The statement also reflects what type of dispute arguments the subject put forth (whether they contested the accuracy of the report or whether they were beyond the scope of NPDB review).

9.3 The system generates the final Consolidated PDF with the complete case record. The record includes the report itself, and all correspondence and documents submitted to the NPDB by the subject of the report and their legal counsel (if any). It also includes correspondence and documents submitted by the reporting entity and the entity’s legal counsel, if any – see attached Appendix II.

9.4 The Operations Team changes the case status to “Case closed” in Tracker and updates the case resolution based on the decision letter (Closed HHS Dispute Denial, Closed HHS Void, or Closed HHS Correction).

9.5 The Operations Team then sends the final decision letter to the subject of the report and the reporting entity electronically, or via regular mail by special request from the subject or reporting entity.

* Note, the subject of the report is responsible for forwarding the final decision letter to their attorney, as applicable.

Appendices

1. Disputes Workflow

2. Sample Redacted Case File(s)