1. Catherine Ballard, Esq., Executive Director1
Massachusetts Association of Medical Staff Services Conference May 20, 2016
Understanding the Health Care Quality Improvement Act and the National Practitioner Data Bank
Catherine Ballard, Esq., Executive Director
The Quality Management Consulting Group, Ltd. v2
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2. History
The Health Care Quality Improvement Act (HCQIA) was enacted in November 1986
To extend immunity to damages to physicians who participated in the peer review process in return for reporting “incompetent” physicians to the National Practitioner Data Bank (NPDB)
The NPDB Guidebook was first issued in September 2001
The second edition of the NPDB Guidebook was issued in Spring 2015. 1
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3. HCQIA Statutory Definitions
Adverse or Adversely affecting: Reducing, restricting, suspending, revoking, denying, or failing to renew clinical privileges or membership in a health care entity.
Clinical privileges: Privileges, membership on the medical staff, and the other circumstances pertaining to the furnishing of medical care at a health care facility
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4. HCQIA Statutory Definitions
Professional review action: An action/recommendation of a professional review body, including its professional review activities relating to a professional review action [or a formal decision of a professional review body not to take an action or recommendation] which is taken or made in the conduct of professional review activity, which is based on the competence/professional conduct of a physician and which conduct
Affects or could affect adversely the health/welfare of a patient; and which
Affects or may affect adversely the clinical privileges of the physician
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5. HCQIA Statutory Definitions
Professional review activity: An activity of a health care entity with respect to an individual physician
To determine whether the physician may have clinical privileges with, or membership in, the entity
To determine the scope or conditions of such privileges or membership
To change or modify such privileges or membership
Professional review body: A health care entity and the governing body or any committee of a health care entity that conducts professional review activity
Includes any committee of the medical staff of such an entity when assisting the governing body in a professional review activity
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6. HCQIA Statutory Immunity
A Professional Review Action will be presumed to be reasonable if it was taken:
In the reasonable belief that the action was in the furtherance of quality health care
After a reasonable effort to obtain the facts of the matter
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7. HCQIA Statutory Immunity
After adequate notice and hearing procedures … or such other procedures as are fair to the physician under the circumstances
Not required where there is no adverse professional review action taken
Not required in the case of a suspension/restriction of clinical privileges for a period not exceeding 14 days during which an investigation is being conducted to determine the need for a professional review action
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8. HCQIA Statutory Immunity
Not required when there is a need to impose an immediate suspension/restriction of clinical privileges (subject to subsequent provision of bullet 3) were the failure to take such an action may result in an imminent danger to the health of any individual
In the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain the facts and after meeting the requirements of the third bullet
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9. HCQIA Statutory Immunity
If this presumption is not rebutted by the physician, then the following are not liable in damages under any federal or state law:
Professional review body
Any person acting as a member or staff to the professional review body
Any person under contract or other formal agreement with the professional review body
Any person who participates with or assists the professional review body
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10. HCQIA Statutory Immunity
Exceptions to immunity provision
A civil rights claim
A federal or state initiated antitrust action
Reporting Immunity: No person or entity may be held liable in any civil action with respect to any report made unless the person submitted the report with knowledge of the falsity of the information contained in the report
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11. HCQIA Reporting Obligations: Insurers
If you are self-insured, you have a duty to report medical malpractice payments
Payment in settlement (or partial settlement) of, or in satisfaction of a judgment in, a medical malpractice action/claim
Includes court proceedings, arbitration, alternative dispute resolution, etc.
A failure to report may result in a civil money penalty of not more than $10,000 for each such payment
Reporting a payment may not be construed as creating a presumption that medical malpractice has occurred
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12. HCQIA Reporting Obligations: Insurers
Examples
Not reportable:
Payment made as the result of an oral demand
Payment made by an individual out of personal funds
Payments made solely for the benefit of a corporation
A payment made on behalf of a medical student.
Reportable:
Payment made on behalf of a resident.
Payment made on behalf of each health care provider named in a release (with apportioned amount as to each).
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13. HCQIA Reporting Obligations: Health Care Entities
A health care entity must report
A professional review action that adversely affects the clinical privileges of a physician for a period of more than 30 days
The acceptance of the surrender of clinical privileges of a physician
While the physician is under an investigation relating to possible incompetence or improper professional conduct OR
In return for not conducting such an investigation or proceeding
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14. HCQIA Reporting Obligations: Health Care Entities
A failure to substantially meet the requirements will result in the health care entity losing the immunity protections for a period of 3 years after publication of the failure by the Secretary.
Must first be given notice of noncompliance and opportunity to correct noncompliance
Entitled to a hearing before final determination
To date, has not occurred
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15. Hospitals Hospitals Must Query: At appointment At reappointment
Whenever a request is made for additional privileges
Applies to all (i.e., with or without clinical privileges and with or without an appointment)
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16. So Who Cares About the Statute
The NPDB Guidebook
Cannot exceed the requirements of HCQIA
Does not have the force of law
It is the agency’s opinion as to how it believes the law should be interpreted
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17. SO LET’S EAT THE ELEPHANT ONE BITE AT A TIME
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18. Heads Up
NPDB has refined its compliance efforts to audit health professions that comprise 80% of the queries to the NPDB and a random sample of all other professionals.
audit includes physicians, registered and advance practice nurses, dentists, physician assistants, and social workers.
Compliance officers will continue comparing board actions taken against these professions with reports in the NPDB and working with boards to reconcile any discrepancies.
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19. The Problem The term “investigation” is not defined by statute.
The Guidebook says that it interprets the word “expansively.”
It commences when the entity begins an inquiry and ends when the decision making authority takes final action; but
A routine formal peer review process whereby the entity evaluates the privilege-specific competence of all practitioners against clearly defined measures is not an investigation.
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20. The Problem
A routine review of a particular practitioner is not an investigation.
A formal targeted process used when issues related to a specific practitioner’s professional competence or conduct are identified is an investigation
The activity generally should be the precursor to a professional review action.
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21. For example, Proctoring
Based on assessment of professional competence, a proctor is assigned to watch a physician’s or dentist’s 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 Dr. Kumquat. Is this reportable to the NPDB?
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22. Proctoring
Per NPDB: If, as a result of a professional review activity related to professional competence or conduct, a proctor is assigned for a period of more than 30 days, it is reportable.
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23. Proctoring
Our position: Yes, if this was imposed by the Medical Executive Committee as the result of a professional review action. No, if this is part of the hospital’s routine peer review program, and the practitioner has voluntarily agreed to the process.
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24. For Example, Applications for Appointment and Reappointment
Dr. Kiwi applies for clinical privileges. The MEC recommends denial based upon clinical care issues. Dr. Kiwi goes through the hearing process. Prior to the Board rendering a final decision, Dr. Kiwi withdraws his application. Is this reportable to the NPDB? Answer: No. Same as above except Dr. Tadpole is going through the reappointment process. Answer: Yes.
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25. For Example, Investigation
Dr. Lychee is on a Hospital’s medical staff. The MEC initiates a formal corrective action investigation. Dr. Lychee resigns from the medical staff totally unaware that the investigation has been initiated. Is this reportable to the NPDB? NPDB: Yes. Our position: Yes, but it really seems unfair. So, be very clear in your governing documents as to when an investigation begins and act promptly in notifying the physician.
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26. Automatic Suspension/Termination
Dr. Banana’s clinical privileges at Holistic Hospital are suspended for quality of care concerns. This results in an automatic suspension of her privileges at Non-Holistic Hospital. Is this reportable to the NPDB? Answer: Yes, regarding Holistic Hospital if suspension is for more than 30 days. No, regarding Non-Holistic Hospital because it was automatically triggered (i.e., it was not based upon quality of care).
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27. Voluntary Agreement Not to Exercise Clinical Privileges: Informal
Dr. Dragonfruit is being reviewed by the Multidisciplinary Peer Review Committee (MPRC). The MPRC asks Dr. D if she will agree not to exercise her privileges while the MPRC conducts an external review of several her cases. The external review has been triggered because: [the committee has concerns; the committee lacks the expertise; the committee does not have an unbiased reviewer; etc.]. NPDB: Yes, because Dr. D is under investigation and has surrendered or restricted her clinical privileges during an investigation.
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28. Voluntary Agreement Not to Exercise Clinical Privileges: Informal
Our position: No. Reporting is related to professional review actions. Only the MEC or the Board has the right to conduct an investigation i.e., an investigation conducted as part of a formal corrective action investigation. Dr. D has not surrendered her privileges; she has agreed not to exercise. Further, HCQIA does not use the term “restricted” in relation to a reporting obligation under these circumstances.
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29. Voluntary Agreement Not to Exercise Clinical Privileges: Formal
The MEC has initiated the formal corrective action process. The MEC has determined that it has grounds to impose a summary suspension. Dr. Mango is advised that he may either voluntarily agree not to exercise his privileges while the investigation is being conducted or he may take the summary suspension (thereby giving him the ability to contest it in a fair hearing process). Dr. Mango voluntarily agrees not to exercise his privileges. Is this reportable to the NPDB? NPDB: Yes, because this constitutes an agreement to restrict clinical privileges while under investigation.
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30. Voluntary Agreement Not to Exercise Clinical Privileges: Formal
Our position: No, because the statute does not authorize reporting based upon a restriction in this situation. It must be a “surrender of clinical privileges.” Further, the intent of HCQIA is to preclude incompetent practitioners from moving from place to place. In this situation, the physician is not resigning; if he does, he will be reported.
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31. Temporary Clinical Privileges
Dr. Lemon has an application pending. He has been granted clinical privileges for 30 days, subject to renewal for additional 30 day periods up to 120 days. At day 26, his temporary privileges are terminated, but his application continues to be processed. Is this reportable to the NPDB? NPDB: Yes, because the clinical privileges were subject to renewal. Our position: Grant temporary privileges for maximum period of time. That way, if they are terminated, you will not have a reportable event.
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32. Catherine Ballard, Esq., Executive Director
Questions?
Catherine Ballard, Esq., Executive Director
The Quality Management Consulting Group, Ltd.
© QMCG 2016