1. Florida Association of Nurse Practitioners August 7, 2015 Margarita Morales, MS U.S. Department of Health and Human Services Health Resources and Services Administration Bureau of Health Workforce Division of Practitioner Data Bank

2. National Practitioner Data Bank (NPDB) General Provisions Reporting and Querying Details o Reporting and Querying Overview o Hospital Querying o Hospital Reporting o Report Subjects o Potential Hospital Sanctions o Continuous Query NPDB Compliance NPDB Guidebook Resources Contact Information Presentation Overview 2

3. General Provisions Purpose 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

4. Merger Goal: Eliminate duplication between the NPDB and HIPDB General Provisions The 3 statutes-- Title IV of Public Law 99-660, Section 1921 of the Social Security Act, and Section 1128E of the Social Security Act -- remain in effect ONE data bank ONE set of regulations governing the NPDB’s operations 4

5. General Provisions Types of Information Collected Medical malpractice judgments, settlements Adverse licensing, 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 & criminal health care-related judgments 5

6. General Provisions Types of Transactions Reporting (no charge) Querying (by hospitals and health care organizations) o $3 for a one-year continuous query subscription o $3 for a one-time query o Fees lowered October 1, 2014 Self-Query (by an individual or organization) o $5 o Fee lowered October 1, 2014 6

7. 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. 7

8. General Provisions Civil Liability Protection 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. 8

9. Reporting and Querying Details 9

10. Reporting and Querying Overview 10 Required Not Authorized Optional

11. 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 11

12. Hospital Querying Centralized Credentialing Querying Through an Authorized Agent Delegated Credentialing Continuous Query 12

13. Hospital Reporting Overview Must report on: Physicians and dentists o Adverse clinical privileges actions >30 days related to professional competence or conduct May report on: Other practitioners o Adverse clinical privileges actions >30 days related to professional competence or conduct 13

14. Hospital Reporting Denials, reductions, and restrictions of privileges Withdrawals and Non- renewals Summary suspensions Report forwarding to State Licensing Boards Investigations o “While under investigation or in return for not conducting such an investigation” 14

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.

16. Report Subjects Approximate Number of New NPDB Reports Submitted On Individual Subjects From 2010 – 2014 by Profession 16

17. Reports by Profession

18. Continuous Query 18

19. 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 19

20. Continuous Query 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. 20 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

21. Continuous Query 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 21

22. Continuous Query 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). 22

23. NPDB Compliance 23

24. To date, NPDB compliance activities have focused primarily on licensing boards Licensing board process updated in January 2015 Currently shifting attention to other areas, in addition to ongoing licensing board efforts: o Medical malpractice o Health plans o Judgments/Convictions o Hospitals Increased focus on improving NPDB registration data and overall data integrity 24 NPDB Compliance

25. State Board Adverse Action Comparison Impact (As of Dec. 2014) -New Reports are those submitted with effective dates during the time period being reviewed (2010-2012) and concurrent with the compliance effort -New Reports Disclosed represents the number of New Reports that have been disclosed as of December 2014 to queriers -Total Disclosures from New Reports represents the number of times the New Reports have been disclosed as of December 2014 to queriers NPDB Compliance 25

26. 2013-2014 State Board Attestation Results (as of Dec. 2014) 2010-2012 State Board Adverse Action Comparison Results (as of Dec. 2014) -Attestation occurs for each board every two years at registration renewal -Profession refers to state/profession combinations -Could Not Attest indicates a statement by the board that it could not attest that all reports have accurately been submitted -Failed to Attest indicates the board failed to provide a response for the profession -Review completed for the 12 most queried professions (i.e., nurses, pharmacists, physician assistants, podiatrists, psychologists, social workers, physicians, dentists, chiropractors, optometrists, physical therapists, and behavioral health professionals) in each state. Allied health professions (e.g., pharmacy technicians, nursing assistants, dental hygienists) were also included. NPDB Compliance 26

27. NPDB Reports Florida APRN vs. Physician NPDB Research Statistics : http://www.npdb.hrsa.gov/resources/npdbstats/npdbStatistics.jsp 27

28. Adverse Action by Report Type - Florida APRN 28 Stahl, Anne L. National Practitioner Data Bank. Location by Payment Year. Generated using the Data Analysis Tool at http://www.npdb.hrsa.gov/analysistool. Jun 05, 2015. Data source: National Practitioner Data Bank (2013): Adverse Action and Medical Malpractice Reports (1990-2013)." http://www.npdb.hrsa.gov/analysistool

29. Adverse Action & Malpractice Payment- Florida APRN 29 Stahl, Anne L. National Practitioner Data Bank. Location by Payment Year. Generated using the Data Analysis Tool at http://www.npdb.hrsa.gov/analysistool. Jun 05, 2015. Data source: National Practitioner Data Bank (2013): Adverse Action and Medical Malpractice Reports (1990-2013)." http://www.npdb.hrsa.gov/analysistool

30. Malpractice Payment Totals Florida APRN Stahl, Anne L. National Practitioner Data Bank. Location by Payment Year. Generated using the Data Analysis Tool at http://www.npdb.hrsa.gov/analysistool. Jun 05, 2015. Data source: National Practitioner Data Bank (2013): Adverse Action and Medical Malpractice Reports (1990-2013)." http://www.npdb.hrsa.gov/analysistool

31. Attestation Required at NPDB registration renewal for all boards licensing or certifying health care professions. Attestation has three parts: Review and update agency’s profile to reflect changes over the last two year period. Profession Verification: agencies review, verify, and update the list of professions they currently regulate. Certification: all agencies attest to their compliance with NPDB reporting requirements for each of their regulated professions. 31 NPDB Compliance

32. Audit of Board Actions One-to-one audit of all professions representing 80% of query volume o Physicians (MD and DO) o Dentists o Physician Assistants o Advanced Practice Nurses o Registered Nurses o Social Workers Random selection of all other professions Sample drawn every two years Any other profession or board may be audited at the discretion of HRSA 32 NPDB Compliance

33. NPDB Guidebook 33

34. 34

35. 35

36. What the new Guidebook does: 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 NOT do: Make revisions that require legislative or regulatory changes Accept or address every recommendation made by commenters. Key Changes 36

37. Eligible entities o Definition of “Other Health Care Entity” o Registration requirements (use of DBIDs, User IDs) Subjects of Reports o Definitions of health care practitioners, providers, and suppliers 37 Key Changes

38. Queries o Centralized credentialing o Delegated credentialing o Clinical vs. non-clinical privileges Reports o Submitting reports -Corrections vs. revisions -Appeals 38 Key Changes

39. Reporting Medical Malpractice Payments o Oral vs. written claims o Identifying practitioners Reporting Adverse Clinical Privileges Actions o Summary Suspensions o Proctors 39 Key Changes

40. o Investigations Definition of term is not controlled by entity’s bylaws. Routine review of a practitioner is not an investigation. Focus on a particular practitioner. Precursor to professional review action. Ongoing until decision-making authority takes final action. 40 Key Changes

41. Reporting Adverse Professional Society Membership Actions o Expert witness testimony Other adjudicated actions o Taken in conjunction with clinical privileges actions 41 Key Changes

42. Reporting Licensure and Certification Actions o Administrative fines o Summary/Emergency suspensions o Stayed actions o Denials o Withdrawals, and failure to renew while under investigation o Voluntary surrenders 42 Key Changes

43. Help When You Need It www.npdb.hrsa.govwww.npdb.hrsa.gov Resources FAQs, Brochures, and Fact Sheets NPDB Guidebook Recorded Webinars Instructions for Reporting and Querying Regulations Statistical Data Research Tools NPDB newsletter NPDB Customer Service Center 800-767-6732 Email help@npdb.hrsa.govhelp@npdb.hrsa.gov NPDB Compliance Tip Line 301-945-9601 43

44. Questions 44

45. Contact Information Margarita Morales, MS Division of Practitioner Data Bank Bureau of Health Workforce Health Resources and Services Administration U.S. Department of Health and Human Services Telephone: 301-443-2300 Email: mmorales@hrsa.govmmorales@hrsa.gov 45

46. Q & A Game 46

47. Question 1: If a State board that regulates NPs issues a cease and desist order against a person who is not a NP but who is practicing as one, is the issuance of the cease and desist order reportable to the NPDB? Subjects of Reports 47

48. Answer 1: Yes. In this example, the State regulates the practice of NPs and prohibits individuals from practicing as NPs – even if they do not refer to themselves as NPs – without being licensed by the board. NPDB regulations require the reporting not only of individuals who are licensed, but also those who hold themselves out to be so licensed. Therefore, the cease and desist order issued by the board would be reportable. Subjects of Reports 48

49. Question 2: Mercury Hospital’s peer review panel restricts a nurse practitioner’s clinical privileges for 30 days due to concerns about his ability to perform certain procedures safely. Is this reportable? Subjects of Reports 49

50. Answer 2: It depends. Clinical privilege actions/panel membership actions taken against a practitioner other than a physician or dentist may be reported. However, to be reportable, the action must adversely affect the practitioner’s clinical privileges for more than 30 days. Subjects of Reports 50

51. Hospital’s Querying Requirement Question 3: Under what conditions are hospitals required to query every 2 years on courtesy staff who are afforded only non-clinical professional privileges? Queries 51

52. Hospital’s Querying Requirement Answer 3: Hospitals are required to query on courtesy staff considered part of the medical staff, even if afforded only non-clinical professional courtesies such as use of the medical library and continuing education facilities. If a hospital extends non- clinical practice courtesies without first appointing practitioners to a medical staff category, querying is not required on those practitioners. Queries 52

53. Hospital’s Querying Requirement Question 4: An advanced practice nurse (APRN) is applying for a position at a hospital. Does the hospital have to query the NPDB on the nurse? Queries 53

54. Hospital’s Querying Requirement Answer 4: It depends. If the hospital considers the position the APRN is applying for to be on the hospital’s medical staff, or if the APRN will hold clinical privileges at the hospital, the hospital must query on the APRN when the APRN applies and biennially thereafter while the APRN is on staff or holds privileges. If the hospital does not consider the position to be on the medical staff or if the APRN will not hold clinical privileges, the hospital is not required to query on the APRN. It may do so if it desires, however. Queries 54

55. Submitting Reports: Correction vs. Revision Question 5: If an entity changes the penalty it imposes or reconsiders the grounds upon which it took an action, should a correction or revision be filed? Reports 55

56. Submitting Reports: Correction vs. Revision Answer 5: If an entity subsequently changed the penalty it imposed, or if it reconsidered the grounds on which it took an action, but the original report correctly described the penalty or grounds at the time the original report was filed, then a Revision- to-Action Report, not a Correction Report, should be filed. Reports 56

57. Medical Malpractice Payments Question 6: Following an unsuccessful course of treatment, a patient and a practitioner enter into a State- sponsored voluntary series of discussions in an attempt to settle their disagreement before resorting to litigation. The discussions lead to the practitioner’s insurance company making a money payment to the patient to settle the dispute. Should this money payment be reported to the NPDB? Reports 57

58. Medical Malpractice Payments Answer 6: It depends. If, during the course of discussions, the patient made a written complaint or written claim demanding a monetary payment for damages, the payment must be reported. If the complaint or claim for damages was never put in writing, the payment is not reportable. Reports 58

59. Medical Malpractice Payments Question 7: If an individual practitioner is not named, identified, or described in a medical malpractice claim or complaint, but the facility or practitioner group is named, should the payment be reported? Reports 59

60. Medical Malpractice Payments Answer 7: No, with one exception. If the named defendant is a sole practitioner identified as a “professional corporation,” a payment made for the professional corporation must be reported for the practitioner. Reports 60

61. Clinical Privileges Actions Question 8: Based on assessment of professional competence, a proctor is assigned to watch a NPs procedures for a period of more than 30 days, and the proctor needs to be present or grant approval before medical care is provided by the practitioner. Is this reportable to the NPDB? Reports 61

62. Clinical Privileges Actions Answer 8: It depends. Clinical privilege actions/panel membership actions taken against a practitioner other than a physician or dentist may be reported. However, to be reportable, the action must adversely affect the practitioner’s clinical privileges for more than 30 days Reports 62

63. Clinical Privileges Actions Question 9: A NP who applied for clinical privileges does not meet a health plan’s threshold criteria for the privileges and withdraws the application. Is this reportable to the NPDB? Reports 63

64. Clinical Privileges Actions Answer 9: No. A health plan should not report the withdrawal of a NPs application for clinical privileges when the NP fails to meet the health plan’s threshold requirements. Reports 64

65. Clinical Privileges Actions Question 10: A NP applied for a medical staff appointment at a hospital but then withdrew the application before a final decision was made by the hospital’s governing body. The NP was not being specifically investigated by the hospital. Should the withdrawal of the application be reported to the NPDB? Reports 65

66. Clinical Privileges Actions Answer 10: No. Absent a particular investigation, the voluntary withdrawal of an application for medical staff appointment or clinical privileges should not be reported to the NPDB. Reports 66

67. Clinical Privileges Actions Question 11: A physician applied to a hospital for clinical privileges to perform cardiac procedures. The hospital requires that such applications be granted only if the applying physician has performed 50 cardiac procedures in the previous year. The applying physician has performed only 40 such procedures. The hospital denies the application based solely on the physician not having met its 50-procedure requirement. Should this denial be reported to the NPDB? Reports 67

68. Clinical Privileges Actions Answer 11: No. A denial of clinical privileges that occurs solely because a practitioner does not meet a health care institution’s established threshold criteria for that particular privilege should not be reported to the NPDB. Such denials are not considered to be the result of a professional review action relating to the practitioner’s professional competence or professional conduct but, rather, are considered to be decisions based on eligibility that are not reportable. Reports 68

69. Clinical Privileges Actions Question 12: When a NP surrenders medical staff privileges due to personal reasons, infirmity, or retirement, and such a surrender did not occur in order to avoid an investigation or during an investigation, should it be reported to the NPDB? Reports 69

70. Clinical Privileges Actions Answer 12: No. The surrender not should not be reported to the NPDB because the NP did not surrender her clinical privileges while under investigation by a health care entity relating to possible professional incompetence or improper professional conduct, or in return for not conducting such an investigation. However, if an investigation was under way when the NP surrendered her privileges, even if the NP was not aware of the investigation, the surrender would have to be reported even if the NP claimed she surrendered the privileges for unrelated personal reasons. Reports 70

71. Clinical Privileges Actions Question 13: A health plan terminated a NPs contract for causes relating to poor patient care, which in turn resulted in the loss of the practitioner’s network participation. Should this be reported to the NPDB using one or two reports? Reports 71

72. Clinical Privileges Actions Answer 13: Depending on the circumstances, the health care entity may be required to submit two different reports. The loss of the practitioner’s network participation that resulted from the termination of the contract for reasons relating to professional competence or professional conduct must be reported as a clinical privileges action only if it is considered to be a professional review action by the health care entity. Reports 72

73. Clinical Privileges Actions Question 14: A preferred provider organization (PPO) investigated a member NP after receiving quality of care complaints from several plan participants. The NP was unaware of the investigation, but, during the investigation, he relinquished his panel membership for personal reasons. Is this reportable? Reports 73

74. Clinical Privileges Actions Answer 14: Yes. A health care entity must report a NPs surrender of panel membership (a form of clinical privileges) while under investigation. The reporting entity should be able to produce evidence that an investigation was initiated prior to the surrender, and the NPs awareness of the investigation is immaterial. In addition, in this situation, any termination of the NPs contract with the PPO must be reported to the NPDB separately if the action meets the definition of an “other adjudicated action or decision.” Reports 74