1. 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 Council on Licensure, Enforcement, and Regulation 2011 Annual Conference September 8, 2011 1 Forewarned is Forearmed: Understanding Data Bank Requirements

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 Compliance Initiatives Continuous Query 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. 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 10

11. NPDB operation commenced September 1, 1990. Reporters are mandated to report:  Medical Malpractice Payments  Licensure Actions  Clinical Privilege Actions  Professional Society Membership Actions  Medicare/Medicaid Exclusions Section 1921 of the Social Security Act expanded the information collected and disseminated through the NPDB to also include:  Negative actions or findings (taken by State licensing boards, peer review organizations, and accreditation organizations) Expansion of NPDB 11

12. NPDB Reporting 12

13. 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. 13

14. 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 14

15. NPDB: Overview of What is Reported Medical malpractice payments Adverse clinical privilege actions taken in the course of professional review activity State licensure actions taken against all health care practitioners and entities Negative actions or findings by peer review organizations and private accreditation organizations Medicare/Medicaid exclusions Adverse registration actions to prescribe controlled medicine taken against health care practitioners 15

16. 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 law of tort 16 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

17. 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 17  Other practitioners MAY be reported NPDB: What is Reported? 2.Adverse Actions

18. 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 18

19. Section 1921 expands the current NPDB adverse licensure action reporting requirements in two ways: 1.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. 2.State licensing authorities must report all adverse licensure actions (not just those based on professional competence and conduct). 19 3.State Licensure Actions NPDB: What is Reported?

20. What is Reportable? 1.License revocations, restrictions, suspensions, surrenders, censures, reprimands, and probations 2.Any dismissal or closure of formal proceedings by reason of the practitioner or entity surrendering the license or leaving the State or jurisdiction 3.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) 4.Summary or emergency suspensions 20 NPDB: What is Reported? 3.State Licensure Actions

21. 21 What is Reportable? (Continued) 4.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.) 5.Revisions to previously reported adverse licensure actions, such as reinstatement of a license NPDB: What is Reported? 3.State Licensure Actions

22. 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) 22 NPDB: What is Reported? 3.State Licensure Actions

23. 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.  23 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

24. What is Reportable? The NPDB contains reports concerning Medicare/Medicaid exclusions against health care practitioners. 24 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?

25. What is Reportable? The Drug Enforcement Administration (DEA) reports adverse registration actions on all health care practitioners who dispense controlled substances. 25 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?

26. NPDB Reports from September 1, 1990 through July 31, 2011 Total Number of Reports in NPDB 26

27. NPDB Reports By Practitioner Data from September 1, 1990 through July 31, 2011 27

28. NPDB Reports By Practitioner (Continued) Data from September 1, 1990 through July 31, 2011 28 * Reporting entity did not identify Occ/Field of State Licensure Code

29. Querying the NPDB 29

30. 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. 30

31. Querying the NPDB (Continued) The Following May Query the NPDB: 31 State licensing boards Other health care entities with a formal peer review process Professional societies with a formal peer review process Health Care Providers (self-query only) Researchers (non-identifying data only)

32. The Following May Query the NPDB under Section 1921: Agencies administering Federal Health Care Programs and their contractors State agencies administering State Health Care Programs State agencies that license health care entities Quality Improvement Organizations (QIOs) Medicaid Fraud Control Units U.S. Attorney General and other law enforcement U.S. Comptroller General 32 Querying the NPDB (Continued)

33. 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 33 Querying the NPDB (Continued)

34. NPDB Queries 34 NPDB Queries from September 1, 1990 through July 31, 2011

35. NPDB: State Licensing Board Queries *Total Queries from January 1, 2000 through February 28, 2010 35

36. 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. 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. 36

37. Healthcare Integrity and Protection Data Bank (HIPDB) ‏ 37

38. HIPDB Law and Regulations 38

39. 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. 39

40. HIPDB Reporting 40

41. 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) 41

42. 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. 42

43. HIPDB: Overview of what is Reported Health care-related criminal convictions Health care-related civil judgments Exclusions from Federal or State health care programs Federal and State licensure and certification actions Other adjudicated actions or decisions 43

44. 44 HIPDB: What is Reported? (Continued) 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)

45. 45 HIPDB: What is Reported? (Continued) 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.

46. HIPDB: What is Reported? (Continued) 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 46

47. HIPDB Reports from August 21, 1996 through July 31, 2011 Total Number of Organization Reports in HIPDB 47

48. HIPDB Reports from August 21, 1996 through July 31, 2011 Total Number of Practitioner Reports in HIPDB 48

49. HIPDB Reports By Practitioner Data from August 21, 1996 through July 31, 2011 49

50. HIPDB Reports By Practitioner (Continued) * Reporting entity did not identify Occ/Field of State Licensure Code Data from August 21, 1996 through July 31, 2011 50

51. HIPDB: Who May Query? Federal and State Agencies Health Plans Practitioners, Providers, Suppliers (self-query only) Researchers using non-identifying data only 51

52. 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). Sanctions: –In accordance with Section 1128E, Government agencies that fail to report will have their name publicly published. –Health plans that fail to report are subject to a civil money penalty of $25,000 for each action not reported. 52

53. HIPDB Queries 53 HIPDB Queries from August 21, 1996 through July 31, 2011

54. HIPDB: State Licensing Board Queries *Total Queries from January 1, 2000 through February 28, 2010 54

55. The HIPDB Merger with NPDB Affordable Care Act: 1.Signed into law on March 23, 2010; 2.Section 6403 calls for the elimination of duplication between the HIPDB and the NPDB; targeted for 2012; in process of developing proposed rules; 3.Requires the Secretary to implement a transition period to cease operating the HIPDB and to transfer HIPDB data to the NPDB; and 4.Will transition HIPDB operations to the NPDB while maintaining reporting and querying requirements. 55

56. Compliance Initiatives 56

57. Compliance Focus: To ensure that the reporting and querying requirements are met by all mandated entities; To educate and provide technical assistance to reporting and querying entities; and Conduct regular data comparisons and provide results back to the State agencies for verification and the opportunity to report missing data Compliance Overview 57

58. Compliance Activities: Explore opportunities to make reporting easier Monitor eligibility of Data Bank Registrants Monitor violations of Confidentiality Rules Post compliance audit results 58 Compliance Overview (Continued)

59. 2010 Compliance Initiatives First Initiative: Identified State agencies responsible for licensing or certifying health care providers Compared list to data in the HIPDB States received letters for “never reported” professions in HIPDB Second Initiative: Compared six frequently queried providers with HIPDB data (Nurses, Podiatrists, Pharmacists, Social Workers, Psychologists, and Physician Assistants) Gap Data sent to the boards for comparison and reconciliation Third Initiative: Compared physician and dentist boards disciplinary actions with HIPDB data Gaps in data sent to boards for comparison and reconciliation 59

60. Compliance Results Posted 60

61. Compliance Results Posted (Continued) Results for Never Reported Professions by Status Total Number of Professions Reviewed as of July 1, 2011 61

62. Results for Adverse Licensure Action Comparison Project: Six Frequently Queried Professions Compliance Results Posted (Continued) 62 Total Number of Actions Reviewed as of July 1, 2011

63. Results for Adverse Licensure Action Comparison Project: Physicians and Dentists Compliance Results Posted (Continued) 63

64. Future Compliance Initiatives Continued efforts on State Licensing Boards Conduct new compliance review on additional frequently Queried Professions Chiropractors Optometrists Physical Therapists Focus on Hospitals, Other Health Care Entities, & Health Plans Clinical Privilege Reporting 64

65. Continuous Query 65

66. Continuous Query 1.Is a subscription service that notifies the subscriber of new information on any of their enrolled practitioners within 24 hours of the Data Bank receipt of the information; 2.Is designed and developed to meet accreditation standards that require ongoing monitoring of practitioners; 3.Replaces the traditional one-time query; Continuous Query requires the same practitioner information. Allows you to continue using your subject database. 66

67. Continuous Query (Continued) 4.Has an annual subscription fee of $3.25 per enrollee, per Data Bank, per year, different from the traditional query fee of $4.75; 5.Enrollment provides you with the same report information as a query response. 6.Continuously queries on your behalf and notifies you of any new reports. No need to re-query for reappointments or temporary privilege extensions 67

68. 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 68

69. Contact Information 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 Telephone: (301) 443-2300 Email: CGrubbs@hrsa.govCGrubbs@hrsa.gov 69

70. Presenters: Promoting Regulatory Excellence Richard P. Morales Colorado Division of Registrations Forewarned is Forearmed: Understanding Data Bank Requirements

71. Forewarned…. What does the letter say? But the national association reported it… So which actions need to be reported? –“Interns” –Interim Actions –Cease and Desist for Unlicensed Practice –Modification, Not New Actions Taking a good hard look 71

72. Colorado Colorado Status as of 7/1/2010 Status as of 10/1/2010 Status as of 4/1/2011 Status as of 7/1/2011 Before July 2010 July 2010 - Aug 2011 DentistNot Reviewed Compliant 866102 Nursing Related Professions (Other than Certified Nurse Aide) Not ReviewedCompliant 25351008 PharmacistNot Reviewed Working Toward Compliance Compliant 55888 Physician - Allopathic and Osteopathic Not Reviewed Compliant 1210135 Physician AssistantNot ReviewedCompliant 7411 PodiatristUnder ReviewCompliant 282 PsychologistUnder Review Working Toward Compliance Compliant 10814 Social WorkerNot ReviewedCompliant 11417 72

73. Colorado 73 Colorado Status as of 7/1/2010 Status as of 10/1/2010 Status as of 4/1/2011 Status as of 7/1/2011 Before July 2010 July 2010 - Aug 2011 Accountant Under ReviewNon-CompliantCompliant 00 Certified Nurse Aide Working Toward Compliance Compliant 01660 Psychiatric Technician Working Toward Compliance Compliant 0136

74. 74 We Have Work To Do! Communicating with HRSA Developing a Compliance Plan –Different for each Board –Some more time consuming than others Executing the Plan Reviewing Progress

75. What We Learned It’s our responsibility Working with National Associations Training Staff Differing Perspectives We’re all on the same team 75

76. 76 Speaker Contact Information Richard P. Morales, Section Director Colorado Division of Registrations (303) 894-7714 richard.morales@dora.state.co.us