1. Overview of Data Bank Reporting Requirements Elizabeth Rezaizadeh, MPH U.S. Department of Health and Human Services Health Resources and Services Administration Bureau of Health Professions Division of Practitioner Data Banks Utah Association of Medical Staff Services (UAMSS) One Day Seminar August 12, 2011 1

2. Presentation Overview Bureau of Health Professions (BHPr) Mission National Practitioner Data Bank Laws, Regulations, Reporting and Querying Healthcare Integrity and Protection Data Bank Laws, Regulations, Reporting and Querying Discussion Scenarios Entity Registration 2

3. HRSA’s Bureau of Health Professions 3

4. Bureau of Health Professions 2010 Reorganization Division of Public Health and Interdisciplinary Education Division of Medicine and Dentistry Division of Nursing Division of Practitioner Data Banks Division of Student Loans and Scholarships Division of Workforce and Performance Management National Center for Workforce Analysis Area Health Education Center Branch Diversity Branch Geriatrics and Allied Health Branch Oral Health Training Branch Primary Care Medical Education Branch Community-Based Training Branch Advanced Nursing Education Branch Community-Based Nursing Branch Nursing Diversity and Development Branch Compliance and Disputes Branch Operations and Administration Branch Loan Repayment Programs Branch HEAL Branch Campus-Based Branch State Workforce Development Branch Performance Management and Program Evaluation Branch Office of Administrative Management Services Office of Shortage Designation Office of Policy Coordination Office of the Associate Administrator Office of Special Initiatives Policy and Research Branch Public Health Branch Children’s Hospital Training Branch 4

5. BHPr Mission Increase the population’s access to health care by providing national leadership in the development, distribution and retention of a diverse, culturally competent health workforce that can adapt to the population’s changing health care needs and provide the highest quality of care for all. 5

6. Division of Practitioner Data Banks The Division of Practitioner Data Banks (DPDB), part of the Bureau of Health Professions, is committed to the development and operation of cost-effective and efficient systems that offer accurate, reliable, and timely information on practitioners, providers, and suppliers to credentialing, privileging and government authorities. 6

7. The National Practitioner Data Bank 7

8. National Practitioner Data Bank (NPDB) Laws and Regulations 8

9. Established through Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986 (HCQIA), as amended Part A – Promotion of Professional Review Activities –Established immunity provisions –Developed through case law, not Federal regulations Part B – Reporting of Information –Established the NPDB 9 NPDB

10. 10 The law’s intent is to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure of previous medical malpractice payment and adverse action history. NPDB

11. Section 1921 Public Law 100-93, Section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987 (Section 1921 of the Social Security Act) Section 1921 amended by the Omnibus Budget Reconciliation Act of 1990, Public Law 101-508 Final regulations codified at 45 CFR Part 60 Final Rule for Section 1921 published in the Federal Register January 28, 2010 Implementation of Section 1921 effective March 1, 2010 11

12. 12 Its intent is to protect beneficiaries participating in the Social Security Act’s health care programs from unfit health care practitioners and improve the anti-fraud provisions of these programs. Section 1921

13. NPDB Expansion: Section 1921 Section 1921 of the Social Security Act –Expands the information collected and disclosed by the NPDB –Authorizes new types of organizations to query and receive Section 1921 information –Requires new organizations to submit reports concerning practitioners and providers to the NPDB, such as state licensure boards for practitioners other than dentists or physicians, as well as for health care organizations 13

14. NPDB Reporting 14

15. Overview of NPDB The NPDB does not collect full records of reported incidents or actions and is not designed to be the sole source of information about a practitioner. If an NPDB report indicates that a settlement was made by or on behalf of a practitioner, it should not be assumed that negligence was involved. Credentialing and privileging should be an objective and circumspect process using all available resources to make an informed decision about a practitioner. 15

16. NPDB: Who Must Report? Malpractice insurers and self-insured organizations State licensing boards for all health care practitioners and entities Hospitals, managed care organizations, other health care entities with formal professional review process  Health care entity provides health care services and follows a formal professional review process to further quality health care. 16

17. NPDB: Who Must Report? (Continued) Professional societies and memberships with formal professional review process Peer review organizations –Excludes Quality Improvement Organizations Private accreditation organizations –e.g., Joint Commission, URAC (formerly known as the Utilization Review Accreditation Commission), & National Council for Quality Assurance (NCQA) Drug Enforcement Administration and HHS Office of Inspector General  Based on Memorandum of Understanding with HHS 17

18. NPDB: Overview of What is Reported 1.Medical malpractice payments 2.Adverse clinical privilege actions taken in the course of professional review activity 3.State licensure actions taken against all health care practitioners and entities 4.Negative actions or findings by peer review organizations and private accreditation organizations 5.Medicare/Medicaid exclusions 6.Adverse registration actions to prescribe controlled medicine taken against health care practitioners 18

19. 1.Medical Malpractice Payments Each person, entity, or insurer that makes a payment under an insurance policy, self-insurance, or otherwise, for the benefit of a physician, dentist, or other health care practitioner in settlement or judgment against a practitioner for medical malpractice must report this payment to the NPDB. Payments made by federal agencies are also reportable. Employers who insure their employees must report medical malpractice payments. 19 NPDB: What is Reported?

20. What Is Reportable? Reportable medical malpractice payments are: –The result of a written complaint or claim demanding payment –Based on provision or failure to provide health care services –Based on tort law 20 What Is Non-Reportable? Payments made in situations where there was no written claim or complaint Payments made to satisfy claims against health care entities that do not identify individual practitioners (Corporate Shield) Individuals who make a malpractice payment from their own personal funds NPDB: What is Reported? 1.Medical Malpractice Payments

21. What is Reportable? All professional review actions taken which: –Concern physicians or dentists  –Are based on professional competence or conduct that adversely affects, or could adversely affect, the health or welfare of a patient –Adversely affect clinical privileges or professional society membership for a period longer than 30 days –Voluntary surrender or restriction of clinical privileges or professional society membership while under, or to avoid, investigation –Summary or emergency suspensions resulting from a professional review action 21  Other practitioners MAY be reported NPDB: What is Reported? 2.Adverse Actions Overview

22. NPDB: What is Reported? What is Non-Reportable? Adverse Actions taken without a formal professional review Actions that do not last longer than 30 days Actions that do not affect or could adversely affect the health or welfare of a patient 2.Adverse Actions Overview 22

23. Section 1921 expands the current NPDB adverse licensure action reporting requirements in two ways: State licensing authorities must report adverse actions taken against all health care practitioners, not just physicians and dentists, as well as those actions taken against health care entities. State licensing authorities must report all adverse licensure actions (not just those based on professional competence and conduct). 23 3.State Licensure Actions NPDB: What is Reported?

24. What is Reportable? License revocations, restrictions, suspensions, surrenders, censures, reprimands, and probations Any dismissal or closure of formal proceedings by reason of the practitioner or entity surrendering the license or leaving the State or jurisdiction Voluntary surrenders or withdrawal of an application for license renewal or a denial of an application for license renewal, and licensure non-renewals (excluding those due to nonpayment of licensure renewal fees, retirement, or change to inactive status) Summary or emergency suspensions 24 NPDB: What is Reported? 3.State Licensure Actions

25. 25 What is Reportable? (Continued) Any negative action or finding that under the State’s law is publicly available information and is rendered by a licensing or certification authority, including, but not limited to, limitations on the scope of practice, liquidations, injunctions and forfeitures (This definition excludes administrative fines or citations, and corrective action plans, unless they are: connected to the delivery of health care services, or taken in conjunction with other licensure or certification actions such as revocation, suspension, censure, reprimand, probation, or surrender.) Revisions to previously reported adverse licensure actions, such as reinstatement of a license NPDB: What is Reported? 3.State Licensure Actions

26. What is Non-Reportable? Monitoring, continuing education, completion of other obligations (unless it constitutes a restriction, a reprimand, etc.) Stayed actions Voluntary relinquishment of license for personal reasons (e.g., retirement or change to inactive status) 26 NPDB: What is Reported? 3.State Licensure Actions

27. What is Reportable? A negative action or finding to sanction a health care practitioner  Any final determination of denial or termination of an accreditation status that indicates a risk to the safety of a patient(s) or quality of health care services. These are taken against health care entities only.  27 4.Peer Review & Private Accreditation Organizations NPDB: What is Reported? What is Non-Reportable? Any action that is not a result of a formal proceeding *Must be the result of formal proceedings with due process

28. What is Reportable? The NPDB contains reports concerning Medicare/Medicaid exclusions against health care practitioners. 28 5.Medicare/Medicaid Exclusions What is Non-Reportable? OIG and HHS reports which do not concern actions taken against health care practitioners who participate in Medicare/Medicaid programs. NPDB: What is Reported?

29. What is Reportable? The Drug Enforcement Administration (DEA) reports adverse registration actions on all health care practitioners who dispense controlled substances. 29 6.Adverse Registration Actions What is Non-Reportable? Registration Reports on practitioners who do not have a Federally assigned DEA identification number to dispense medication. NPDB: What is Reported?

30. NPDB Reports from September 1, 1990 through December 31, 2010 Total Number of Reports in NPDB 30

31. Top 5 NPDB AARs by Type NPDB Reports from September 1, 1990 through December 31, 2010 31

32. NPDB Reports By Practitioner * Reporting entity did not identify Occ/Field of State Licensure Code Data from September 1, 1990 through December 31, 2010 32

33. NPDB Reports By Practitioner (Continued) Data from September 1, 1990 through December 31, 2010 33

34. NPDB Reports from September 1, 1990 through December 31, 2010 Top 10 Practitioner NPDB Reports by Type 34

35. Querying the NPDB 35

36. Querying the NPDB Hospitals Must Query by Law: –When physicians, dentists, and other health care practitioners apply for staff appointments (courtesy or otherwise) or for clinical privileges; and –Every 2 years on all physicians, dentists, and other health care practitioners who hold clinical privileges at the hospital. 36

37. Querying the NPDB (Continued) Hospitals May Query: –At any other time with respect to professional review activities. 37

38. Querying the NPDB (Continued) The Following May Query the NPDB: 1.State licensing boards 2.Other health care entities with a formal peer review process 3.Professional societies with a formal peer review process 4.Health Care Providers (self-query only) 5.Researchers (non-identifying data only) 38

39. The Following May Query the NPDB under Section 1921: 1.Agencies administering Federal Health Care Programs and their contractors 2.State agencies administering State Health care programs 3.State Agencies that license health care entities 4.Quality Improvement Organizations (QIOs) 39 Querying the NPDB (Continued)

40. The Following May Query the NPDB under Section 1921: 5.Medicaid Fraud Control Units 6.U.S. Attorney General and other law enforcement 7.U.S. Comptroller General 40 Querying the NPDB (Continued)

41. Access to Section 1921 Data ONLY –Entities that are currently allowed to query the NPDB have access to all Section 1921 reports e.g., hospitals, health care entities, State boards –Entities given access to the NPDB through Section 1921 are allowed to query ONLY Section 1921 information  –Practitioners and entities can self-query only –Researchers can use non-identifying data only  These entities also have access to Medicare/Medicaid exclusions 41 Querying the NPDB (Continued)

42. NPDB Queries 42 NPDB Queries from September 1, 1990 through December 31, 2010

43. NPDB: Summary of Other Provisions Timeframe for reporting is within 30 days of the date of the adverse action or the date a medical malpractice payment was made. Medical malpractice payers and health care entities must send a copy of the NPDB report to the appropriate State licensing board. 43

44. NPDB: Summary of Other Provisions (Continued) Health care entities can be sanctioned for failure to report or query (mandatory hospital queries only). NPDB information is confidential ($11,000 civil monetary penalty per violation). By law, the NPDB must recover full cost of operations. The current fee is $4.75 per query. 44

45. Healthcare Integrity and Protection Data Bank (HIPDB) ‏ 45

46. HIPDB Law and Regulations 46

47. HIPDB: Law and Regulations Established under Section 1128E of the Social Security Act as added by Section 221(a) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Final regulations governing the HIPDB are codified at 45 CFR Part 61. 47

48. Purpose: To deter fraud and abuse in the health care system and to promote quality health care by collecting and disseminating final adverse actions taken against health care practitioners, providers, and suppliers. 48 HIPDB: Law and Regulations (Continued)

49. HIPDB Reporting 49

50. HIPDB: Who Must Report? 1.Federal and State Agencies Licensing and certification agencies Department of Justice, law enforcement agencies, Medicaid Fraud Control Units (MFCUs) Department of Health and Human Services (e.g., Centers for Medicare & Medicaid Services (CMS), U.S. Food and Drug Administration (FDA), Office of Inspector General) Agencies that administer or pay for the delivery of health care services (e.g., Dept. of Veterans Affairs) 50

51. HIPDB: Who Must Report? (Continued) 2.Health Plans Any plan, program, or organization that provides health care benefits, whether directly or through insurance, reimbursement, or otherwise that take a reportable panel membership action. 51

52. HIPDB: Overview of what is Reported 1.Health care-related criminal convictions 2.Health care-related civil judgments 3.Exclusions from Federal or State health care programs 4.Federal and State licensure and certification actions 5.Other adjudicated actions or decisions 52

53. 53 1.Health care-related criminal convictions include: Events related to the delivery of health care items or services; When a judgment or conviction is entered against the individual or entity in a Federal, State, or local court; When a plea of guilty or nolo contendere by the individual or entity is accepted by a court; and When there is a finding of guilt against the individual or entity in court. HIPDB: What is Reported?

54. 54 2.Health care-related civil judgments include: Court-ordered actions rendered in a Federal or State court proceeding (not a criminal proceeding); Events related to the delivery of a health care item or service, regardless of whether the judgment is the subject of a pending appeal; and Government Agencies that are party to a multi- claimant civil judgment  Must assume the responsibility for reporting the entire action  Exception for consent agreements in which there is no finding or admission of liability HIPDB: What is Reported? (Continued)

55. 55 HIPDB: What is Reported? (Continued) 3.Exclusions from Federal or State health care programs include: Temporary or permanent debarments of an individual or entity from participation in a Federal or State health-related program (includes the furnishing of items or services)

56. 56 HIPDB: What is Reported? (Continued) 4.Federal and State licensure and certification actions include: Final adverse licensure actions taken against health care practitioners, providers, or suppliers; Formal or official actions Revocation or suspension of a license or certification agreement or contract and the length of any such suspension, reprimand, censure, or probation Any loss of license, certification agreement, contract, or the right to apply for or renew a license or certification agreement or contract, whether by operation of law, voluntary surrender, non-renewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status)

57. 57 HIPDB: What is Reported? (Continued) 4.Federal and State licensure and certification actions include: Any negative action or finding by Federal or State agency that is publicly available information and is rendered by a licensing or certification authority; and Need not be specifically related to professional competence or conduct.

58. HIPDB: What is Reported? (Continued) 5. Other Adjudicated Actions or Decisions that include due process which*: Are formal or official final actions taken against a provider, supplier, or practitioner by a Federal or State Government agency or a health plan; and Are based on acts or omissions that affect, or could affect, the payment, provision or delivery of a health care item or service e.g. contract terminations. *Specifically excludes clinical privileges or panel membership actions 58

59. HIPDB Reports from August 21, 1996 through December 31, 2010 Total Number of Organization Reports in HIPDB 59

60. HIPDB Reports from August 21, 1996 through December 31, 2010 Total Number of Practitioner Reports in HIPDB 60

61. HIPDB Reports By Practitioner Data from August 21, 1996 through December 31, 2010 61

62. HIPDB Reports By Practitioner (Continued) * Reporting entity did not identify Occ/Field of State Licensure Code Data from August 21, 1996 through December 31, 2010 62

63. HIPDB: Who May Query? Federal and State Agencies Health Plans Practitioners, Providers, Suppliers (self-query only) Researchers using non-identifying data only 63

64. HIPDB: Other Provisions Overview Timeframe for reporting is generally within 30 days. Civil liability protection is available for all reporters. The HIPDB must recover the full cost of operations. (Current fee is $4.75 per query). 64

65. HIPDB Queries 65 HIPDB Queries from August 21, 1996 through December 31, 2010

66. Discussion Scenarios 66

67. Discussion Scenario:1 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 to the NPDB, HIPDB, neither, or both? 67

68. Discussion Scenario:1 Answer ANSWER: Neither NPDB: Clinical privilege actions/panel membership actions taken against a practitioner other than a physician or dentist may be reported to the NPDB. However, to be reportable, the action must affect the practitioner’s clinical privileges for more than 30 days. HIPDB: Clinical privilege actions/panel membership actions are not reportable to the HIPDB. 68

69. Discussion Scenario: 2 Greenville Hospital suspends Dr. Zeus’ clinical privileges for 31 days for repeatedly failing to complete medical records. During its investigation, the hospital determined that these failures put patient care at risk. Is this reportable to the NPDB, HIPDB, neither, or both? 69

70. Discussion Scenario: 2 Answer ANSWER: Reportable to NPDB NPDB: The suspension of clinical privileges is in effect for more than 30 days, and the hospital based the action on reasons related to professional competence or conduct that adversely affects or could adversely affect, the health or welfare of a patient. HIPDB: Clinical privilege actions/panel membership actions are not reportable to the HIPDB. 70

71. Discussion Scenario: 3 Meadow Behavioral Health Plan’s standard operating procedures require that practitioners be afforded due process when contract actions are taken for cause and that a committee of peers makes all panel membership determinations. After receiving and substantiating complaints about Dr. Aphrodite’s surgical skills, Meadow Behavioral Health Plan removed Dr. Aphrodite from its panel. The Health Plan also took a formal action to terminate Dr. Aphrodite’s contract for cause. Is this reportable to the NPDB, HIPDB, neither, or both? 71

72. Discussion Scenario: 3 Answer ANSWER: Both the NPDB and the HIPDB NPDB: Meadow Behavioral Health Plan’s panel membership action meets the NPDB’s reporting requirements. It was a professional review action based on the practitioner’s professional competence or conduct and adversely affected the practitioner’s panel membership for more than 30 days. (The contract termination is not reportable to the NPDB.) HIPDB: T he contract termination is reportable, as it was a formal action that afforded due process and was based on acts or omissions that affect or could affect the payment, provision or delivery of a health care item or service. (Clinical privilege actions/panel membership actions are not reportable to the HIPDB.) 72

73. Discussion Scenario: 4 Dr. Mars took a voluntary leave of absence from General Hospital’s medical staff to enter a rehabilitation program for her substance abuse problem. Dr. Mars did not surrender her clinical privileges and the hospital took no action against her. Is this reportable to the NPDB, HIPDB, neither, or both? 73

74. Discussion Scenario: 4 Answer ANSWER: Neither NPDB: The voluntary entrance of an impaired practitioner into a rehabilitation program is not reportable to the NPDB 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 the reporting requirements (based on competence/conduct and affects privileges for more than 30 days). HIPDB: Dr. Mars’ voluntary leave of absence does not meet the reporting requirements of an adjudicated action or decision. 74

75. Discussion Scenario: 5 The chairman of City Hospital’s cardiology department summarily suspends Dr. Pluto’s clinical privileges for failing to respond to an emergency department call. The summary suspension, which is subsequently reviewed and confirmed by the medical executive committee, is in effect for 60 days. The hospital’s bylaws state that summary suspension decisions by the medical executive committee are considered to be professional review actions. Is this reportable to the NPDB, HIPDB, neither, or both? 75

76. Discussion Scenario: 5 Answer ANSWER: NPDB NPDB: Summary suspensions that are the result of a professional review action, are in effect for more than 30 days, and are based on professional competence or conduct are considered reportable to the NPDB. Summary suspensions are considered to be final when they become professional review actions through action of the authorized hospital committee or body, according to the hospital bylaws. HIPDB: Clinical privilege actions/panel membership actions are not reportable to the HIPDB. 76

77. Discussion Scenario: 6 The Felton Health Plan wins a civil judgment in the amount of $170,000 against a clinical laboratory for submitting claims for services not rendered. Is this reportable to the NPDB, HIPDB, neither, or both? 77

78. Discussion Scenario: 6 Answer ANSWER: HIPDB NPDB: Civil judgments are not reportable to the NPDB. However, a payment made for the benefit of a health care practitioner in satisfaction of a medical malpractice claim or judgment is reportable to the NPDB. HIPDB: Federal and State attorneys and health plans must report civil judgments against health care practitioners, providers, or suppliers related to the delivery of a health care item or service, regardless of whether the civil judgment is the subject of a pending appeal. 78

79. Entity Registration 79

80. Entity Registration Security Goal is to ensure users accessing the Data Bank are: Are who they say they are Are affiliated with the organization on whose behalf they are assessing the Data Bank Enhancing security in compliance with Federal requirements E-Authentication Guidance for Federal Agencies (OMB M-04-04) Electronic Authentication Guidelines (National Institutes of Standards and Technology (NIST) Draft Special Publication 800-63-1) 80

81. Reference Information Web Site - www.npdb-hipdb.hrsa.govwww.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 81

82. Thank you for this opportunity to speak with you today! 82

83. Contact Information 83 Elizabeth Rezaizadeh, MPH Public Health Analyst, Division of Practitioner Data Banks Telephone: 301- 443-2300 Email: ERezai@hrsa.gov ERezai@hrsa.gov