1. North Carolina Association Medical Staff Services May 12, 2016 Margarita Morales, MD Division of Practitioner Data Bank - Liaison Bureau of Health Workforce (BHW) Health Resources and Services Administration (HRSA)

2. Overview National Practitioner Data Bank (NPDB) general provisions Reporting and Querying Updates Updated NPDB Guidebook System enhancements Education opportunities New compliance efforts Resources Contact information 2

3. Created under three statutes to meet several needs: Flagging system for effective credential reviews Protection against unfit practitioners Deter fraud and abuse in the health care system 3 Purpose

4. General Provisions Medical malpractice judgments, settlements Adverse licensing and certification actions Clinical privileges actions Health plan contract terminations Professional society membership actions Negative actions/findings from private accreditation organizations and peer review organizations Government administrative actions, e.g., exclusions from programs Civil and criminal health care-related judgments Types of Information Collected 4

5. General Provisions Reporting (no charge) Querying (by hospitals and health care organizations) $3 for a one-year continuous query subscription $3 for a one-time query Fees are currently being re-evaluated Self-Query (by an individual or organization) $5 Fees are currently being re-evaluated Types of Transactions 5

6. General Provisions Recovering Costs By law, the NPDB must recover the full cost of operations. It does so by collecting fees for each query. Confidentiality Information reported to the NPDB is confidential, not available to the general public, and may not be disclosed except as provided by law. Penalty up to $11,000 per confidentiality violation. 6 General Provisions

7. Immunity provisions in Title IV, Section 1921 and Section 1128E protect individuals, entities, and their authorized agents from being held liable in civil actions for reports made to the NPDB unless they have actual knowledge that the information in the report is false Health care entity professional review bodies, their members, and their agents are immune from civil liability in most cases Civil Liability Protection 7

8. Querying and Reporting Details & Sanctions 8

9. Querying and Reporting Overview ENTITY TYPEREPORTQUERY Hospitals Health plans Other health care entities with formal peer review State agencies that license and certify health care practitioners and entities, including boards of medical and dental examiners State agencies administering or supervising state health care programs State law enforcement or fraud enforcement agencies (including state Medicaid fraud control units and state prosecutors) Federal licensing and certification agencies Agencies administering federal health care programs, including private entities administering such programs under contract Federal law enforcement officials and agencies (including Drug Enforcement Agency, HHS Office of Inspector General, and federal prosecutors) Medical malpractice payers Professional societies with formal peer review Peer review organizations (excluding quality improvement organizations) Private accreditation organizations Quality improvement organizations Individual practitioners, providers, and suppliers (self-query only) 9 Required Not Authorized Optional

10. Hospital Querying May query on: Health care practitioners with whom the hospital has entered (or maybe entering) employment or affiliation relationships Must query on: Health care practitioners when practitioners apply for staff appointments (courtesy or otherwise) or clinical privileges (including temporary privileges); every two years for practitioners on staff or with clinical privileges 10 Hospital Querying

11. Centralized Credentialing Querying Through an Authorized Agent Delegated Credentialing (Hospitals May Not Delegate Responsibility) Continuous Query 11 Hospital Querying

12. Hospital Reporting Overview Must report on: Physicians and dentists Adverse clinical privileges actions >30 days related to professional competence or conduct May report on: Other practitioners Adverse clinical privileges actions >30 days related to professional competence or conduct 12 Hospital Reporting

13. Denials, reductions, and restrictions of privileges Withdrawals and Non- renewals Investigations Summary suspensions “While under investigation or in return for not conducting such an investigation” Report forwarding to State Licensing Boards 13 Hospital Reporting

14. Report Subjects Approximate Number of New NPDB Reports Submitted On Individual Subjects From 2010 – 2014 by Profession

15. Potential Hospital Sanctions Failure to Report Loss of immunity protections provided for professional review activities that occur during the 3-year period and organization name published in the Federal Register 15 Failure to Query Plaintiff is allowed access to NPDB information on that practitioner for use in litigation against the hospital. Potential Hospital Sanctions

16. Continuous Query 16

17. Continuous Query Purpose A subscription service that notifies subscribers of new information on any of their enrolled practitioners within one business day of the NPDB’s receipt of the information Designed and developed to help meet new accreditation standards that require ongoing monitoring of practitioners Since 2007, health care providers have enrolled more than 1.85 million practitioners 17 Continuous Query

18. With One-Time Query An average of 320 days pass between receipt of a report and disclosure of the report in response to a query. Re-credentialing means re- querying practitioners and reviewing all results to identify new information – a tremendous amount of effort for large organizations. 18 With Continuous Query Service notifies subscribers of a report on their enrolled practitioners within one business day of receipt by the NPDB By handling new reports as they are disclosed, subscriber organizations are always up to date. Subscribers can deal only with events that need attention, immediately resolving issues Continuous Query

19. Using Continuous Query Requires the same practitioner information Subscribers continue using their subject databases Fee: $3.00 per enrollee per year No separate query fee Upon enrollment, receive the same report information as a one-time query response Continuously queries the NPDB and notifies subscribers of any new reports No need to re-query for reappointments or temporary privileges extensions 19 Continuous Query

20. Using Continuous Query, continued Notification sent via email; subscriber must log in to retrieve information Subscription period for each enrollee is 12 months Subscription expires on the last day of the same month of the following year: All subscriptions begun in December 2014 will expire on December 31, 2015. 20 Continuous Query

21. Enrollment Based on a subscriber’s current registration For each practitioner, subscriber receives an initial query and continuous monitoring for one year 21 Continuous Query

22. Enrollment Confirmation Returned for every enrolled subject Confirms that practitioner is enrolled in Continuous Query May be used to demonstrate compliance with accreditation standards Includes subject information, enrollment dates and status, and any report made on the practitioner 22 Continuous Query

23. Endorsements The Joint Commission National Committee for Quality Assurance (NCQA) Commission on Accreditation of Rehabilitation Facilities (CARF) Utilization Review Accreditation Commission (URAC) Centers for Medicare & Medicaid Services (CMS) Using Continuous Query helps meet obligations imposed by the Health Care Quality Improvement Act of 1986 (HCQIA). 23 Continuous Query

24. Renewing Practitioners Manually renew practitioners: Monthly email notifications sent 60 days before renewal Sign in to renew practitioners One-month grace period after enrollment ends Renew practitioners automatically: Sign in to turn on auto-renewals Effortless, continuous coverage 24 Continuous Query

25. Canceling Practitioners Must cancel enrollment when practitioner leaves organization Can schedule cancellations for future date – for example, with locum tenens practitioners Practitioner information can be returned to subscriber’s subject database Canceled practitioners’ enrollment confirmations available for 4 years 25 Continuous Query

26. Monthly Email Messages Subscribers receive monthly email message summarizing Continuous Query activities for the month: Upcoming renewals Number of disclosures Number of Continuous Queries submitted Renewals processed Scheduled cancellations Total enrollments 26 Continuous Query

27. Continuous Query System Demo 27

28. What do you get from a Continuous Query? Query Response Review 28

29. Guidebook 29

30. Guidebook Overview Announced publication of draft NPDB Guidebook in Federal Register on December 27, 2013 Comment period ended January 10, 2014 Received 360 comments Final version released April, 2015 Revision Process 30 Link http://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp

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33. Guidebook Key Changes Blends Healthcare Integrity and Protection Data Bank and NPDB to reflect new combined regulations Adds Section 1921 Provides policy clarification What the new Guidebook does 33 What the new Guidebook does NOT do Make revisions that require legislative or regulatory changes Accept or address every recommendation made by commenters

34. Key Changes Definition of “Other Health Care Entity” Registration requirements (use of DBIDs, User IDs) 34 Eligible Entities Subjects of Reports Definitions of health care practitioners, providers, and suppliers

35. Key Changes Centralized credentialing Delegated Credentialing Clinical vs. non-clinical privileges 35 Queries Reports Submitting reports Corrections vs. revisions Appeals

36. Key Changes Oral vs. written claims Identifying practitioners 36 Reporting Medical Malpractice Payments Reporting Adverse Clinical Privileges Actions Summary Suspensions Proctors

37. Key Changes Definition of term is not controlled by entity’s bylaws Routine review of a practitioner is not an investigation Focus must be on a particular practitioner Precursor to professional review action Ongoing until decision-making authority takes final action Investigations 37

38. Key Changes Expert witness testimony 38 Reporting Adverse Professional Society Membership Actions Reporting Other Adjudicated Actions Taken in conjunction with clinical privileges actions

39. Key Changes Administrative fines Summary/emergency suspensions Stayed actions Denials Withdrawals and failure to renew while under investigation Voluntary surrenders Reporting Licensure and Certification Actions 39

40. System Enhancements

41. Enhancements New website phased in beginning June 1, 2015 Continual process of updating and improving Eager for suggestions for topics or layout Website 41 Landing Pages Organizing content by type of user One-stop shopping for applicable content Resources and Help content more visible

42. Enhancements Can purchase an unlimited number of credits with a single transaction by the Data Bank Administrator Credits can be applied to continuous query enrollments and renewals or to one-time queries All authorized users can use the credits and check the balance Non-refundable, but never expire Automatic low-balance notifications for the Data Bank Administrator Prepayment for Queries 42

43. Enhancements Combined 3 pages into 1 Added a review step Allows users to confirm information before submitting 43 Query Form Online Account Self-Service Options to retrieve your password, user ID, or entity DBID without calling Customer Service Email sent with a link to the requested information – links are only valid for 1 hour

44. Enhancements View notifications for all entities on the options page Download all unviewed responses and disclosures at one time Create multiple additional enrollments for an existing enrollment Complete a query on behalf of multiple entities with one submission Agents and CVOs 44

45. Education

46. Education Forum Reporting: Current issues Query Response: Getting the most out of the NPDB through queries Research Applications: Using the NPDB research tools Guidebook: Overview Technology: See re-designed query screens and other new features Open Forum 46 Agenda

47. Webinars Increasing use of webinars for educational opportunities Larger webinars may be recorded and shared online Informational webinar on the Guidebook with NAMSS (June, 2015) available on YouTube: https://www.youtube.com /watch?v=KzEXN3_MS0Q https://www.youtube.com /watch?v=KzEXN3_MS0Q 47 NAMSS

48. NPDB Compliance

49. Compliance Activities 49 Current Activities Focused primarily on licensing boards Licensing boards process updated in 2015

50. Compliance Activities 50 On the Menu Shifting attention to other areas Community health centers Hospitals Health plans Focus on improving NPDB registration data and overall data integrity

51. Compliance Activities 51 Steps to Expand Compliance Identify universe of entities Are entities registered? Reporting? Querying? Contact entities Explain NPDB obligations Work on issues that arise Set up proactive targeted outreach and education

52. Resources Website: www.npdb.hrsa.gov FAQs, brochures, and fact sheets NPDB Guidebook Recorded webinars Regulations Statistical data Research tools Instructions for reporting and querying NPDB Insights Help When You Need It 52 NPDB Customer Service Center 800.767.6732 help@npdb.hrsa.gov

53. Questions 53

54. Contact Information Margarita Morales, MS Liaison – Division of Practitioner Data Bank Bureau of Health Workforce (BHW) Health Resources and Services Administration (HRSA) Email: mmorales@hrsa.gov Phone: 301-443-2300 Web: npdb.hrsa.gov Twitter: twitter.com/HRSAgov Facebook: facebook.com/HHS.HRSA

55. Additional Information 55

56. Reporting Compliance 56

57. 57

63. Reporting Sample Scenarios 63

64. Reporting Scenarios Scenario 1: Robert Violet, a Nurse Practitioner, took a voluntary leave of absence from Autumn Hospital’s medical staff to enter a rehabilitation program for his substance abuse problem. Mr. Violet did not surrender his clinical privileges and the hospital has taken no action against him. Is this reportable? 64

65. Reporting Scenarios Answer 1: No The voluntary entrance of an impaired practitioner into a rehabilitation program is not reportable if no action was taken and the practitioner did not relinquish his or her clinical privileges. If an impaired practitioner is required by a professional review action to involuntarily enter a rehabilitation program, the professional review action is reportable if the action meets standard reporting requirements (competence/conduct; more than 30 days). 65

66. Reporting Scenarios Scenario 2: A Medical Executive Committee (MEC) conducted a formal investigation on cases handled by Dr. Shane Catskill, who specialized in pain management. The review was to determine if care that he provided met the standard of care set by the hospital. Specifically, the doctor chose to use aggressive therapies for cancer patients, resulting in patient complaints. On many occasions, Catskill used aggressive treatment that required insertion of neurostimulators to stimulate the spinal cord with an electric current that interrupted the transmission of pain signals. 66

67. Reporting Scenarios The device was supposed to stabilize nerve signals by acting like a pacemaker for the spine. However, many of Catskill’s patients said they had an increase in pain sensations, experienced temporary paralysis, and began to have spasms. The MEC requested Catskill to refrain from exercising clinical privileges during the investigation, and the doctor agreed. The investigation took 60 days. Reportable or not? 67

68. Reporting Scenarios Answer 2: Reportable An agreement that a practitioner not use privileges during an investigation is a suspension of clinical privileges and is reportable if the suspension lasts for more than 30 days. 68

69. Reporting Scenarios Scenario 3: A young physician, Dr. Jackson McGraw, requested additional privileges to perform palatoplasty, a surgical procedure used to construct or repair cleft palates. As part of the Children’s Hospital’s standard procedures, a physician must be guided for 12 cases in three months before privileges are granted. The 12 cases could not be completed within three months because of scheduling conflicts with skilled physicians. As a result, Dr. McGraw was not allowed to perform the procedures unless a qualified surgeon, acting as first assistant, was present. Is this reportable? 69

70. Reporting Scenarios Answer 3: Not reportable This requirement regarding Dr. McGraw’s privileges is not reportable to the NPDB because it was not an adverse action based on competence or conduct. It was part of normal, routine hospital procedures to assure that a practitioner is competent to perform expanded privileges. If a proctoring requirement were imposed as the result of a professional review action, that would be reportable. 70

71. Reporting Scenarios Scenario 4: The Renew Surgical Center, a part of the University of Santa Barbara, was famous for its remarkable surgeons specializing in cosmetic and reconstructive surgery. One of the first physicians at the center, Dr. Julius Rodgers, started to have an increase in complication rates during rhinoplasties. Specifically, many of his high-risk patients suffered perforated septa. The Surgical Advisory Committee at the university decided that a second opinion would be required before Dr. Rodger’s rhinoplasty procedures. 71

72. Reporting Scenarios His seniority as a surgeon gave the committee confidence to require only a second opinion and not require permission to perform the surgery. However, he could not perform the surgery until a second opinion was obtained. Is this reportable? 72

73. Reporting Scenarios Answer 4: Reportable The doctor was correctly reported to the NPDB as having had his privileges restricted. The timing of when a second opinion is required is critical in determining whether a reportable event occurred. When the second opinion is required before the practitioner can perform a procedure, this constitutes a restriction of privileges. When the second opinion is required only after the procedure, a restriction of privileges has not been imposed. 73

74. Reporting Scenarios Scenario 5: Dr. Erica Smith, an anesthesiologist employed by Memorial Hospital, had an employment contract that provided that if the employment contract was terminated for any reason, her medical staff privileges at the hospital would automatically terminate. After several months of complaints of abusive behavior, Human Resources terminated her employment contract, citing the 90-day termination without cause provision. As a result, her privileges were automatically terminated and she was not offered a hearing through the medical staff bylaws. Is this reportable? 74

75. Reporting Scenarios Answer 5: Not Reportable Dr. Smith’s privileges were automatically terminated without having been the subject of a professional review action. Her contract was terminated without cause; 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. 75

76. Reporting Scenarios Scenario 6: Dr. Theodore White, a 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 her review after the radiologist resigned, and she determined there were no issues with the standard of care. Is this reportable? 76

77. Reporting Scenarios Answer 6: Probably Not The reportability depends on whether the review of Dr. White’s cases was part of the routine peer review process or a professional review activity. It is likely that the Chair’s review was part of a routine peer review process, which is not an investigation, and therefore is not reportable. Alternatively, if the review had been initiated by the credentials committee or MEC, it would be a professional review activity 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. 77