NPDB Reporting When to Report & When not to Report Cynthia Grubbs R.N., J.D. U.S. Department of Health and Human Services Health Resources and Services Administration Bureau of Health Professions Division of Practitioner Data Banks Timothy B. Adelman Adelman, Sheff & Smith, LLC 1 Presentation Overview The Data Bank Background New Initiatives Compliance Update Reporting Scenarios 2 1
The Data Bank A confidential clearinghouse used to: Protect the public, Promote quality health care, Prevent patient harm and Combat health care fraud and abuse in the United States. The Data Bank is made up of two data banks: The National Practitioner Data Bank (NPDB) The Healthcare Integrity and Protection Data Bank (HIPDB). 3 Background The Data Bank is a result of 3 separate laws created at 3 separate times. Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986 established the NPDB. Section 1921 of the Social Security Act. Section 1128E of the Social Security Act added by Section 221 (a) of the Health Insurance Portability and Accountability Act of 1996. The 2010 Affordable Care Act requires the merger of the HIPDB into the NPDB. Execution of the data merge is slated for 2012. 2
New Initiatives The Guidebook Will incorporate Section 1921 statutory reporting and querying requirements effective March 1, 2010 A major draft was completed in 2011 and is currently being reviewed by Data Bank leadership HIPDB Merger with NPDB Section 6403 of the Patient Protection and Affordable Care Act Notice of Proposed Rule Making Secretarial Review Process Information Sharing Electronically without compromising Personal Identifiable Information Compliance Update Report Forwarding Hospital Compliance State Compliance Results 3
Compliance Activities Results Results for Never Reported Professions by Status Compliant Non-Compliant Working Toward Compliance Under Review See Comparison Project July 2010 October 2010 April 2011 July 2011 October 2011 263 (40%) 416 (68%) 496 (83%) 493 (85%) 494 (86%) 80 (12%) 96 (16%) 48 (8%) 34 (6%) 19 (3%) 154 (23%) 83 (13%) 52 (9%) 52 (9%) 43 (7%) 160 (24%) 16 (3%) 0 (0%) 0 (0)% - - - - - 22 (4%) *Table displays rounded percentage values 7 Scenario 1 Agreement Not to Exercise Privileges During an Investigation Physician used aggressive therapies for cancer patients. There were a high number of patient complaints resulting from his therapies. The Medical Executive Committee initiated a formal investigation by having an outside reviewer look at a sample of his cases. The Medical Executive Committee requested that physician refrain from exercising clinical privileges during the investigation into his practice and the physician agreed. 8 4
Scenario 1 Agreement Not to Exercise Privileges During an Investigation REPORTABLE - An agreement not to exercise privileges during an investigation is a suspension of clinical privileges and is a reportable event. What if it was the Department Chair that asked the practitioner not to practice pending the review? What if the MEC tells the practitioner that if he post any cases, he will be/may be suspended but does not take action until (if) a case is posted? 9 Scenario 2 Required Second Opinion but Not Permission A surgeon at the Hospital began having an increased rate of complications following rhinoplasties. The Surgical Advisory Committee at the Hospital decided that a second opinion would be required prior to the surgeon s performing a rhinoplasty. While the surgeon was required to obtain a second opinion, she could perform the surgery regardless of what the second opinion said. 10 5
Scenario 2 Required Second Opinion but Not Permission NOT REPORTABLE There is no restriction on Dr. Rodger s privileges since she can perform the procedure regardless of what the second opinion says. If the practitioner was required to obtain concurrence with a second opinion before performing the procedure, than it would be a restriction on the practitioner s privileges and reportable. Mandatory post surgical reviews are not a restriction on privileges and are not reportable. 11 Scenario 3 Requirement to Perform Operation with a Qualified Surgeon as a First Assistant Surgeon requested additional privileges to perform palatoplasty, a surgical procedure used to construct or repair cleft palates. As part of the Hospital s standard procedures, a physician must be proctored for 12 cases in 3 months before privileges are granted. The 12 cases could not be completed within 90 days due to scheduling conflicts with qualified proctors. Because he did not complete the proctoring, surgeon was not allowed to perform the procedures unless a qualified surgeon acted as first assistant. 12 6
Scenario 3 Requirement to Perform Operation with a Qualified Surgeon as a First Assistant NOT REPORTABLE - This is not reportable to the Data Bank because it is not an adverse action based on competence or conduct. If a first assistant was required due to a professional review action, it would be reportable. 13 Scenario 4 Settlement of a Claim by a Hospital Based on Vicarious Liability for Non-Defendant Physicians Emergency physician treated a patient for a leg injury following a motorcycle accident. Ultimately the patient s leg was amputated and the patient sued the Hospital for alleged negligence of the physician. Physician was not named as a defendant in the case. However, his care and treatment was the focus of the Plaintiff s case. Due to the agency relationship, the Hospital would be deemed vicariously liable for his actions. The Hospital settled the claim and did not include the physician in the release. 14 7
Scenario 4 Settlement of a Claim by a Hospital Based on Vicarious Liability for Non-Defendant Physicians NOT REPORTABLE If physician not named as a defendant and is not identified in the release, then this is not reportable. If physician was named in the release, then it would be reportable as it was a payment to settle a claim on his behalf. 15 Scenario 5 Removal from On-Call Roster Orthopedic surgeon works at the local Hospital. He never had problems showing up on time for scheduled procedures but was always late in responding in person to call. Due to complaints by nurses and other physicians, the Medical Executive Committee initiated an investigation into surgeon s delay in responding to call. As result of the investigation, surgeon was removed from the on-call list. No action was taken against his privileges. 16 8
Scenario 5 Removal from On-Call Roster NOT REPORTABLE Because there was no restriction on surgeon s privileges, removal from on-call roster is not an reportable event. If surgeon s privileges were suspended for more than 30 days due to his delay in responding to call, that would be a reportable event. 17 Scenario 6 Contract Termination Radiologist employed by a hospital had an employment contract which provided that if the employment contract was terminated for any reason, her medical staff privileges at the Hospital would automatically terminate. Radiologist developed a history of being disruptive by yelling at nurses and a radiology technicians. After several months of employee complaints, Human Resources terminated her employment contract, citing the 90 day termination without cause provision. Because her employment contract was terminated the radiologist s medical staff privileges automatically terminated and she was not offered a hearing through the medical staff bylaws. 18 9
Scenario 6 Contract Termination NOT REPORTABLE Radiologist s privileges were automatically terminated without having been the subject of a professional review action. Her contract was terminated without cause; and, therefore, her automatic termination of privileges is not reportable. If the Hospital or Medical Staff initiated an investigation to look into her professional misconduct and her contract was terminated due to her professional misconduct, then her termination would have been a professional review action that is reportable. 19 Scenario 7 Action Based Solely on an Action Taken at another Hospital Physician has medical staff privileges at St. John s Hospital and City Hospital. Physician has always had an excellent reputation at St. John s Hospital but had a history of behavior complaints at City Hospital. Based on those complaints, physician s privileges were terminated at City Hospital. St. John s Hospital Medical Staff Bylaws provide that if a practitioner s privileges are terminated, restricted or suspended at another other Hospital, their privileges at St. John s Hospital shall be automatically suspended pending further investigation. When St. John s Hospital learned of the City Hospital action, it suspended Dr. Smith for more than 30 days. 20 10
Scenario 7 Action Based Solely on an Action Taken at another Hospital NOT REPORTABLE By St. John s Hospital - Physician s suspension was not based on a professional review action at St. John s Hospital. Therefore, his suspension is not reportable. If the MEC s investigation reveals behavioral issues that cause St. John s Hospital to continue the suspension beyond the initial period necessary to explore the reason for his privileges being terminated at City Hospital, then the suspension would be reportable. 21 Scenario 8 Agreement to Withdraw a Request for Privileges during Reappointment During the reappointment process, the credentials committee identified a number of physician s cases wherein she gave out prescriptions to individuals without properly evaluating them. Physician decided to withdraw her application for reappointment. 22 11
Scenario 8 Agreement to Withdraw a Request for Privileges during Reappointment REPORTABLE - The reappointment process is a professional review action. Physician resigned while undergoing the professional review action. Therefore, the resignation is reportable. What happens if there are no issues identified during the reappointment process but the physician decides to take a job in a new location? 23 Scenario 9 Resignation while Quality is being Reviewed by the Department Chair. Radiologist had several cases with inconsistent initial reads versus final reads that were being reviewed by the Chair of Radiology as part of the Department of Radiology s quality program. While the cases were still being reviewed by the Chair of Radiology, the radiologist resigned from the medical staff and took a position with another Hospital. The Chair of Radiology completed his review after the radiologist resigned and determined there were no issues with the standard of care. 24 12
Scenario 9 Resignation while Quality is being Reviewed by the Department Chair. NOT REPORTABLE Whether this event is reportable depends on whether the review of the radiologist s cases was part of the routine peer review process or a professional review action. We assume the Chair s review was part of a routine peer review process and not a professional review action; therefore, his resignation was not during an investigation. 25 Scenario 9 Resignation while Quality is being Reviewed by the Department Chair. If the review of radiologist s cases was initiated by the credentials committee or MEC, it is a professional review action since that does not occur in the ordinary course of peer review. Therefore, such a review would be an investigation and require reporting if radiologist resigned during the investigation. The fact that the review subsequently came back positive does not relieve the obligation to report a resignation during an investigation. 26 13
Scenario 10 Resignation during a Focused Professional Peer Evaluation (FPPE) Surgeon newly appointed to the medical staff at City Hospital is required to undergo an FPPE for the first year of his appointment. The FPPE includes a random review of his surgical cases by the peer review committee. After 8 months, surgeon receives an offer from another hospital and leaves City Hospital. He resigns his medical staff privileges before the FPPE is completed. To his knowledge, there were no issues raised by the peer review committee during the FPPE. 27 Scenario 10 Resignation during a Focused Professional Peer Evaluation (FPPE) NOT REPORTABLE FPPE initiated that is part of a routine peer review process as a result of initial medical staff privileges is not reportable because it is not a professional review action. 28 14
Scenario 10 Resignation during a Focused Professional Peer Evaluation (FPPE) If an FPPE is initiated because of concerns about a providers professional conduct or clinical skills, then it is considered an investigation and a resignation during the FPPE is a reportable event. The key is to determine when FPPE is a routine peer review process and when it is used in response to a specific concern about a provider. If the practitioner refuses to cooperate with an FPPE process, i.e. produce office records, and is terminated for failing to comply with the FPPE process, the termination is reportable. 29 Scenario 11 Resignation during a preliminary inquiry not considered a Formal Investigation Surgeon has been the subject of numerous complaints at the Hospital by nursing staff. As a side note, surgeon was previously dating one of the OR nurses and the relationship ended poorly. The medical staff bylaws provide that the MEC can request the department chair or other designee to conduct a preliminary inquiry into complaints. The Chair of Surgeon initiates a preliminary inquiry by discussing the complaints with surgeon and speaking with various OR nurses. While this preliminary inquiry is ongoing, surgeon resigns from the medical staff. 30 15
Scenario 11 Resignation during a preliminary inquiry not considered a Formal Investigation NOT REPORTABLE A preliminary inquiry is not an investigation if it is clearly distinguished from an investigation by the bylaws. Simply because a complaint is alleged and the Hospital does some fact checking into the complaint does not mean that a formal investigation has been initiated. Because a formal investigation has not been initiated, the resignation is not reportable. 31 Scenario 12 Voluntary Surrender of Select Privileges in Response to Pattern of Adverse Outcomes An OB/GYN has had a series of adverse outcomes following high risk deliveries. The peer review committee recommended a FPPE of the physician s OB cases over the next six months. After five months of the FPPE, the physician decides to resign her OB privileges but continue her GYN privileges. 32 16
Scenario 12 Voluntary Surrender of Select Privileges in Response to Pattern of Adverse Outcomes REPORTABLE The resignation of her OB privileges during an FPPE based on concerns about clinical competence is a reportable event. The practitioner does not need to resign all of their privileges but only some portion of privileges for it to be a reportable event. 33 Scenario 12 Voluntary Surrender of Select Privileges in Response to Pattern of Adverse Outcomes Assume the FPPE process has completed and the recommendation of the peer review committee is for the physician to undergo additional training, but there are no restrictions on the physicians privileges while she obtains the training. After the physician receives the recommendation she resigns. This is not a reportable event since she is not resigning while under investigation. 34 17
Scenario 13 Suspension/Termination for Criminal Conduct Outside of the Hospital A physician with an excellent record at the hospital was reported in the news as having been arrested for a DUI. The MEC received notice of this and suspended the physician s medical staff privileges, pending completion of a substance abuse evaluation. The physician scheduled the evaluation 20 days after the suspension but the report was not reviewed by the MEC until more than 30 days after his initial suspension. The MEC determined that the physician did not have an alcohol problem that would adversely affect patient safety and reinstituted his full privileges 50 days after the suspension. 35 Scenario 13 Suspension/Termination for Criminal Conduct Outside of the Hospital REPORTABLE The MEC s purpose in suspending the physician was based on patient safety. Therefore, this is a professional review action that would be a reportable event. 36 18
Scenario 13 Suspension/Termination for Criminal Conduct Outside of the Hospital If the MEC had suspended the physician because of the potential negative image of having a doctor with a DUI on staff, but not because of concerns about patient safety, then it would not be reportable since it was not a suspension as a result of a professional review action. If the physician was charged with domestic violence and the Medical Staff Bylaws provided for summary suspension if a practitioner is charged with a felony, the suspension would not be reportable unless the Hospital determined that the felony charge related to professional conduct at the Hospital. 37 Scenario 13 Suspension/Termination for Criminal Conduct Outside of the Hospital When is suspension/termination based on being charged with/convicted of a crime reportable? Tax evasion Theft Assault Possession of child pornography Perjury Possession of illegal firearms Possession of illegal drugs 38 19
Scenario 13 Suspension/Termination for Criminal Conduct Outside of the Hospital When is suspension/termination based on being charged with/convicted of a crime reportable? To what extent does the decision depend on whether taking action would be protected by immunity provisions of HCQIA regarding action taken in the reasonable belief that it is in the furtherance of quality health care? 39 Reference Information Web Site - www.npdb-hipdb.hrsa.gov NPDB and HIPDB Guidebooks Interactive Training FAQs, Brochures, and Fact Sheets Statistics Annual Reports Instructions for Reporting and Querying Customer Service Center 1-800-767-6732 40 20
Contact Information Cynthia Grubbs, RN, JD Director, Division of Practitioner Data Banks Telephone: 301-443-2300 Email: CGrubbs@hrsa.gov Timothy B. Adelman Adelman, Sheff & Smith, LLC Telephone: 410-224-3000 Email: tadelman@hospitallaw.com 41 21