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2011 CLEAR Annual Educational ConferenceForewarned is Forearmed: Understanding DataBank Requirements

September 8-10

Pittsburgh, Pennsylvania 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 Regulation2011 Annual Conference

September 8, 2011

1

Forewarned is Forearmed:Understanding Data Bank Requirements

Presentation Overview

• Bureau of Health Professions (BHPr) Mission

• National Practitioner Data Bank Laws,Regulations, Reporting and Querying

• Healthcare Integrity and Protection DataBank Laws, Regulations, Reporting andQuerying

• Compliance Initiatives

• Continuous Query

2

HRSA’s Bureau of HealthProfessions

3


September 8-10



2010 Reorganization

Division of PublicHealth and

InterdisciplinaryEducation

Divisionof Medicine

and Dentistry

Division ofNursing

Division ofPractitioner Data

Banks

Division of StudentLoans and

Scholarships

Division ofWorkforce andPerformanceManagement

National Centerfor

WorkforceAnalysis

Area Health EducationCenter Branch

Diversity Branch

Geriatrics andAllied Health Branch

Oral Health TrainingBranch

Primary CareMedical Education

Branch

Community-BasedTraining Branch

Advanced NursingEducation Branch

Community-BasedNursing Branch

Nursing Diversityand

Development BranchCompliance andDisputes Branch

Operations andAdministration Branch

Loan RepaymentPrograms Branch

HEAL Branch

Campus-BasedBranch

State WorkforceDevelopment Branch

Performance Managementand Program Evaluation

Branch

Office of AdministrativeManagement Services

Office of ShortageDesignation

Office of PolicyCoordination

Office of the Associate Administrator

Office of SpecialInitiatives

Policy andResearch Branch

Public HealthBranch

Children’s HospitalTraining Branch 4

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

Division of PractitionerData 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


September 8-10


The National PractitionerData Bank

7

National Practitioner Data Bank(NPDB)

Laws and Regulations

8

• Established through Title IV of Public

Law 99-660, the Health Care QualityImprovement Act of 1986 (HCQIA), as amended

• Part A – Promotion of Professional ReviewActivities– Established immunity provisions

– Developed through case law, not Federal regulations

• Part B – Reporting of Information– Established the NPDB

9

NPDB


September 8-10


Section 1921

• Public Law 100-93, Section 5 of the Medicare andMedicaid Patient and Program Protection Act of 1987(Section 1921 of the Social Security Act)

• Section 1921 amended by the Omnibus BudgetReconciliation Act of 1990, Public Law 101-508

• Final regulations codified at 45 CFR Part 60

• Final Rule for Section 1921 published in the FederalRegister January 28, 2010

• Implementation of Section 1921 effective March 1, 2010

10

• 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 expandedthe information collected and disseminated throughthe NPDB to also include:

Negative actions or findings (taken by State licensing boards, peerreview organizations, and accreditation organizations)

Expansion of NPDB

11

NPDB Reporting

12


September 8-10


NPDB: Who Must Report?

• Malpractice insurers and self-insuredorganizations

• State licensing boards for all health carepractitioners and entities

• Hospitals, managed care organizations, otherhealth care entities with formal professionalreview process Health care entity provides health care services and follows aformal professional review process to further quality health care.

13

NPDB: Who Must Report?(Continued)

• Professional societies and memberships with formalprofessional review process

• Peer review organizations

– Excludes Quality Improvement Organizations

• Private accreditation organizations

– e.g., Joint Commission, URAC (formerly known asthe Utilization Review Accreditation Commission),National Council for Quality Assurance (NCQA)

• Drug Enforcement Administration and HHS Office ofInspector General Based on Memorandum of Understanding with HHS

14

NPDB: Overview of What isReported

• Medical malpractice payments

• Adverse clinical privilege actions taken in thecourse of professional review activity

• State licensure actions taken against all healthcare practitioners and entities

• Negative actions or findings by peer revieworganizations and private accreditationorganizations

• Medicare/Medicaid exclusions

• Adverse registration actions to prescribe controlledmedicine taken against health care practitioners

15


September 8-10


What Is Reportable?

• Reportable medicalmalpractice payments are:– The result of a written

complaint or claimdemanding payment

– Based on provision orfailure to providehealth care services

– Based on law of tort

16

What Is Non-Reportable?

• Payments made in situations wherethere was no written claim orcomplaint

• Payments made to satisfy claimsagainst health care entities that donot identify individual practitioners(Corporate Shield)

• Individuals who make a malpracticepayment from their own personalfunds

NPDB: What is Reported?

1.Medical Malpractice Payments

What is Reportable?

• All professional review actions taken which:

– Concern physicians or dentists

– Are based on professional competence or conduct that adverselyaffects, or could adversely affect, the health or welfare of a patient

– Adversely affect clinical privileges or professional societymembership for a period longer than 30 days

– Voluntary surrender or restriction of clinical privileges orprofessional society membership while under, or to avoid,investigation

– Summary or emergency suspensions resulting from a professionalreview action

17 Other practitioners MAY be reported


2. Adverse Actions


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 thehealth or welfare of a patient

2. Adverse Actions

18


September 8-10


Section 1921 expands the current NPDB adverselicensure action reporting requirements in two ways:

1. State licensing authorities must report adverseactions taken against all health care practitioners,not just physicians and dentists, as well as thoseactions taken against health care entities.

2. State licensing authorities must report all adverselicensure actions (not just those based onprofessional competence and conduct).

19

3. State Licensure Actions


What is Reportable?

1. License revocations, restrictions, suspensions, surrenders,censures, reprimands, and probations

2. Any dismissal or closure of formal proceedings by reason of thepractitioner or entity surrendering the license or leaving the State orjurisdiction

3. Voluntary surrenders or withdrawal of an application for licenserenewal or a denial of an application for license renewal, andlicensure non-renewals (excluding those due to nonpayment oflicensure renewal fees, retirement, or change to inactive status)

4. Summary or emergency suspensions

20



21

What is Reportable? (Continued)

4. Any negative action or finding that under the State’s law is publiclyavailable information and is rendered by a licensing or certificationauthority, including, but not limited to, limitations on the scope ofpractice, liquidations, injunctions and forfeitures (This definitionexcludes administrative fines or citations, and corrective action plans,unless they are: connected to the delivery of health care services, ortaken in conjunction with other licensure or certification actions suchas revocation, suspension, censure, reprimand, probation, orsurrender.)

5. Revisions to previously reported adverse licensure actions, such asreinstatement of a license




September 8-10



• Monitoring, continuing education,completion of other obligations(unless it constitutes a restriction,a reprimand, etc.)

• Stayed actions

• Voluntary relinquishment oflicense for personal reasons (e.g.,retirement or change to inactivestatus)

22



What is Reportable?

• A negative action or finding tosanction a health carepractitioner

• Any final determination ofdenial or termination of anaccreditation status thatindicates a risk to the safety ofa patient(s) or quality of healthcare services. These aretaken against health careentities only.

23

4. Peer Review & Private Accreditation Organizations



• Any action that is not a result ofa formal proceeding

*Must be the result of formal proceedings with due process

What is Reportable?

The NPDB contains reports

concerning Medicare/Medicaid

exclusions against health care

practitioners.

24

5. Medicare/Medicaid Exclusions


OIG and HHS reports which do

not concern actions taken against

health care practitioners who

participate in Medicare/Medicaid

programs.



September 8-10


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


Registration Reports on

practitioners who do not have

a Federally assigned DEA

identification number to

dispense medication.


NPDB Reports from September 1, 1990 through July 31, 2011

Total Number of Reports in NPDB

26

NPDB Reports By Practitioner

Physician 385,682Paral-Professional Nurses 134,052Professional Nurses 125,663Dentist 68,825Pharmacists and Assistants 31,210Chiropractors 16,196Podiatrists/Assistants 10,209Counselers/Marriage/Family Therapist 7,830Physical Therapists and Assistants 5,664Social Workers 5,276Psychologists/Assistants/Associates 4,916Emergency Medical Technicians (EMT) 4,625Physician Assistants 4,585Respiratory Therapists/Technologists 4,199Other Rehab/Restorative Service Practitioners 2,850

Data from September 1, 1990 through July 31, 2011 27


September 8-10


NPDB Reports By Practitioner(Continued)

Dental Assistants/Hygienists 2,713Other Health Care Practitioners 2,639Optometrists 2,465

Other Technologists/Techs 2,448

Occupational Therapists/Assistants 1,459

Speech/Language Pathologists/Audiologists 1,094

Organization 1,081

Complimentary Medicine Practitioners 811

Unspecified or Unknown Individual* 800

Assistive Devices Service Practitioners 724

Other Health Care Occupation 709

Dieticians/Nutritionists 167

Medical Assistants 68

Non-Health Care Occupation 1

Total 828,961

Data from September 1, 1990 through July 31, 2011 28

*Reporting entity did not identify Occ/Field of State Licensure Code

Querying the NPDB

29

Querying the NPDB

Hospitals Must Query by Law:

• When physicians, dentists, and other healthcare practitioners apply for staff appointments(courtesy or otherwise) or for clinicalprivileges; and

• Every 2 years on all physicians, dentists, andother health care practitioners who holdclinical privileges at the hospital.

30


September 8-10


Querying the NPDB(Continued)

The Following May Query the NPDB:

31

• State licensing boards

• Other health care entities with a formal peer reviewprocess

• Professional societies with a formal peer review process

• Health Care Providers (self-query only)

• Researchers (non-identifying data only)

The Following May Query the NPDB

under Section 1921:

• Agencies administering Federal Health CarePrograms and their contractors

• State agencies administering State Health CarePrograms

• 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


Access to Section 1921 Data ONLY

• Entities that are currently allowed to query theNPDB have access to all Section 1921 reportse.g., hospitals, health care entities, State boards

• Entities given access to the NPDB throughSection 1921 are allowed to query ONLYSection 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



September 8-10


NPDB Queries

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

NPDB: State Licensing Board Queries

*Total Queries from January 1, 2000 through February 28, 2010 35

NPDB: Summary of OtherProvisions

• Timeframe for reporting is within 30 days of thedate of the adverse action or the date a medicalmalpractice payment was made.

• Medical malpractice payers and health careentities must send a copy of the NPDB report tothe appropriate State licensing board.

• NPDB information is confidential ($11,000 civilmonetary penalty per violation).

• By law, the NPDB must recover full cost ofoperations. The current fee is $4.75 per query.

36


September 8-10


Healthcare Integrity andProtection Data Bank

(HIPDB)

37

HIPDB Law and Regulations

38

HIPDB: Law and Regulations

• Established under Section 1128E of theSocial Security Act as added by Section221(a) of the Health Insurance Portabilityand Accountability Act of 1996 (HIPAA).

• Final regulations governing the HIPDB arecodified at 45 CFR Part 61.

39


September 8-10


HIPDB Reporting

40

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 InspectorGeneral)

• Agencies that administer or pay for the delivery of healthcare services (e.g., Dept. of Veterans Affairs)

41

HIPDB: Who Must Report?(Continued)

2. Health Plans

• Any plan, program, or organization thatprovides health care benefits, whetherdirectly or through insurance,reimbursement, or otherwise that take areportable panel membership action.

42


September 8-10


HIPDB: Overview of what isReported

• Health care-related criminal convictions

• Health care-related civil judgments

• Exclusions from Federal or State healthcare programs

• Federal and State licensure andcertification actions

• Other adjudicated actions or decisions

43

44

HIPDB: What is Reported?(Continued)

Federal and State licensure and certification

actions include:

• Final adverse licensure actions taken againsthealth 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 suchsuspension, reprimand, censure, or probation

• Any loss of license, certification agreement, contract, orthe right to apply for or renew a license or certificationagreement or contract, whether by operation of law,voluntary surrender, non-renewal (excluding non-renewalsdue to nonpayment of fees, retirement, or change to

inactive status)

45


Federal and State licensure and certification

actions include:

• Any negative action or finding by Federal or Stateagency that is publicly available information and isrendered by a licensing or certification authority;and

• Need not be specifically related to professionalcompetence or conduct.


September 8-10



Other Adjudicated Actions or Decisions that

include due process which*:

• Are formal or official final actions taken against aprovider, supplier, or practitioner by a Federal orState Government agency or a health plan; and

• Are based on acts or omissions that affect, orcould affect, the payment, provision or delivery of ahealth care item or service e.g. contractterminations .

*Specifically excludes clinical privileges or panel membership actions

46

HIPDB Reports from August 21, 1996 through July 31, 2011

Total Number of OrganizationReports in HIPDB

47

HIPDB Reports from August 21, 1996 through July 31, 2011

Total Number of PractitionerReports in HIPDB

48


September 8-10


HIPDB Reports By Practitioner

Paral-Professional Nurses 144,400

Professional Nurses 123,658

Physician (MDs/DOs) 69,704

Pharmacists and Assistants 29,998

Non-Health Care Occupation 22,182

Dentist 19,692

Organization 15,856

Chiropractors 11,629

Counselers/Marriage/Family Therapist 7,717

Social Workers 5,271

Emergency Medical Technicians (EMT) 4,898

Physical Therapists and Assistants 4,618

Respiratory Therapists/Technologists 4,158

Psychologists/Assistants/Associates 3,930

Other Rehab/Restorative Service Practitioners 2,884

Physician Assistants 2,850

Data from August 21, 1996 through July 31, 2011 49

HIPDB Reports By Practitioner(Continued)

Podiatrists/Assistants 2,821

Other Health Care Practitioners 2,717

Dental Assistants/Hygienists 2,662

Health Care Facility Administrators 2,660

Other Technologists/Techs 2,226

Optometrists 1,900

Occupational Therapists/Assistants 1,403

Speech/Language Pathologists/Audiologists 1,104

Assistive Devices Service Practitioners 797

Complimentary Medicine Practitioners 767

Other Health Care Occupation 684

Researcher, Clinical 319

Unspecified or Unknown Individual* 231

Dieticians/Nutritionists 162

Medical Assistants 77

Total 493975

*Reporting entity did not identify Occ/Field of State Licensure Code

Data from August 21, 1996 through July 31, 2011 50

HIPDB: Who May Query?

• Federal and State Agencies

• Health Plans

• Practitioners, Providers, Suppliers(self-query only)

• Researchers using non-identifying dataonly

51


September 8-10


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 moneypenalty of $25,000 for each action not reported.

52

HIPDB Queries

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

HIPDB: State Licensing Board Queries

*Total Queries from January 1, 2000 through February 28, 2010 54


September 8-10


The HIPDB Merger with NPDB

Affordable Care Act:

1. Signed into law on March 23, 2010;

2. Section 6403 calls for the elimination of duplicationbetween the HIPDB and the NPDB; targeted for2012; in process of developing proposed rules;

3. Requires the Secretary to implement a transitionperiod to cease operating the HIPDB and to transferHIPDB data to the NPDB; and

4. Will transition HIPDB operations to the NPDB whilemaintaining reporting and querying requirements.

55

Compliance Initiatives

56

Compliance Focus:

• To ensure that the reporting and queryingrequirements are met by all mandated entities;

• To educate and provide technical assistance toreporting and querying entities; and

• Conduct regular data comparisons and provide resultsback to the State agencies for verification and theopportunity to report missing data

Compliance Overview

57


September 8-10


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)

2010 Compliance Initiatives

First Initiative:

• Identified State agencies responsible for licensing or certifying healthcare 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 PhysicianAssistants)

• 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

Compliance Results Posted

60


September 8-10


Compliance Results Posted(Continued)

Results for Never Reported Professions by Status

Total Number of Professions Reviewed as of July 1, 2011 61

Results for Adverse Licensure Action Comparison Project:

Six Frequently Queried Professions


62Total Number of Actions Reviewed as of July 1, 2011

Total Number of Actions Reviewed as of July 1, 2011

Results for Adverse Licensure Action Comparison Project:Physicians and Dentists


63


September 8-10


Future Compliance Initiatives

Continued efforts on State Licensing Boards

• Conduct new compliance review on additional frequentlyQueried Professions

• Chiropractors

• Optometrists

• Physical Therapists

Focus on Hospitals, Other Health Care Entities, & Health Plans

• Clinical Privilege Reporting

64

Continuous Query

65

Continuous Query

1. Is a subscription service that notifies the subscriberof new information on any of their enrolledpractitioners within 24 hours of the Data Bankreceipt of the information;

2. Is designed and developed to meet accreditationstandards that require ongoing monitoring ofpractitioners;

3. Replaces the traditional one-time query;

• Continuous Query requires the same practitionerinformation.

• Allows you to continue using your subjectdatabase.

66


September 8-10


Continuous Query(Continued)

4. Has an annual subscription fee of $3.25 per enrollee,per Data Bank, per year, different from the traditionalquery fee of $4.75;

5. Enrollment provides you with the same reportinformation as a query response.

6. Continuously queries on your behalf and notifies you ofany new reports.• No need to re-query for reappointments or

temporary privilege extensions

67

Reference Information

Web Site - www.npdb-hipdb.hrsa.gov

– NPDB and HIPDB Guidebooks

– Interactive Training

– FAQs, Brochures, and Fact Sheets

– Statistics

– Annual Reports

– Instructions for Reporting and Querying

Customer Service Center

– 1-800-767-6732

68

Contact Information

Cynthia Grubbs, R.N., J.D.

U.S. Department of Health and Human Services

Health Resources and Services Administration


Division of Practitioner Data Banks

Telephone: (301) 443-2300

Email: [email protected]

69


September 8-10


Presenters:

Promoting Regulatory Excellence

Richard P. MoralesColorado Division of Registrations

Forewarned isForearmed:

Understanding DataBank Requirements

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

Colorado

ColoradoStatus as of7/1/2010

Status as of10/1/2010



Before July2010

July 2010 -Aug 2011

Dentist Not Reviewed Not Reviewed Compliant Compliant 866 102

Nursing Related Professions(Other than Certified Nurse

Aide)Not Reviewed Compliant Compliant Compliant 2535 1008

Pharmacist Not ReviewedWorkingToward

ComplianceCompliant Compliant 558 88

Physician - Allopathic andOsteopathic

Not Reviewed Not Reviewed Compliant Compliant 1210 135

Physician Assistant Not Reviewed Compliant Compliant Compliant 74 11

Podiatrist Under Review Compliant Compliant Compliant 28 2

Psychologist Under ReviewWorkingToward


Social Worker Not Reviewed Compliant Compliant Compliant 114 17

72


September 8-10


Colorado

73

ColoradoStatus as of7/1/2010




Before July2010

July 2010 -Aug 2011

Accountant Under Review Non-Compliant Compliant Compliant 0 0

Certified Nurse AideWorkingToward

Compliance

WorkingToward


Psychiatric TechnicianWorkingToward

Compliance

WorkingToward


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

What We Learned

• It’s our responsibility

• Working with National Associations

• Training Staff

• Differing Perspectives

• We’re all on the same team

75


September 8-10


76

Speaker Contact Information

• Richard P. Morales, Section Director

Colorado Division of Registrations

(303) 894-7714

[email protected]

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