Effective March 1, 2010, a Final Rule published by the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), expands the scope of information required to be reported to the National Practitioner Data Bank (NPDB), and even expands who can query certain parts of the NPDB.

This advisory summarizes important information that physicians, hospitals, other health facilities, health plans and health care providers need to know now about these significant changes. In a nutshell, as a result of this Final Rule, health care entities will now be reported to the NPDB—not just individual practitioners. That is, state licensing authorities, Private Accreditation Entities and Peer Review Organizations will report to the NPDB certain recommendations, findings and sanctions against health care practitioners and health care entities. Also, law enforcement and numerous other state and federal agencies can now check portions of the NPDB.

  1. Does this Final Rule change the current NPDB reporting requirements for hospitals or medical malpractice payers?

No. The Final Rule does not change current NPDB reporting requirements for hospitals, other health care entities, professional societies, DEA, HHS OIG or medical malpractice payers.1

In other words, medical malpractice payments and adverse actions involving clinical privileges are still reportable to the NPDB after March 1, just as they were reportable before March 1. The Final Rule does, however, increase the penalty for a failure to report from $10,000 to $11,000. 2

  1. What are the Final Rule’s main changes to the NPDB?

NPDB Reports by State Licensing Authorities. As a result of the Final Rule, state licensing authorities will report the following to the NPDB, if taken as the result of a formal proceeding: adverse licensure and other negative actions and findings taken by state licensing authorities against a hospital, other health care entity, physician, dentist or health care practitioner.3

Reports by Peer Review Organizations and Private Accreditation Entities. As a result of the Final Rule, certain Peer Review Organizations and Private Accreditation Entities (if they have due process mechanisms) will report the following to the NPDB, if taken as the result of a formal proceeding: certain “negative actions or findings” taken against a health care practitioner, physician, dentist, hospital or other health care entity.4

Greater Access to NPDB. As a result of the Final Rule, certain information in the NPDB will now be available to many government agencies, including those administering federal and state health care programs, state licensing authorities, federal and state law enforcement officials and agencies and state Medicaid Fraud Control Units.5 Also, hospitals and other health care entities will now be able to query the NPDB for physicians or other licensed health care practitioners who have entered (or may enter) into employment or affiliation relationships with them. Hospitals and other health care entities will now be able to self-query the NPDB, too.

  1. What is a “negative action or finding” by a Peer Review Organization or Private Accreditation Entity?

The Final Rule defines a negative action or finding to include:6

  • A final determination of denial or termination of an accreditation status from a Private Accreditation Entity that indicates a risk to patients’ safety or quality of health care services;  
  • A recommendation by a Peer Review Organization to sanction a health care practitioner, physician or dentist; or  
  • A negative action or finding that under the state’s law is publicly available information and rendered by a licensing or certification authority, including, but not limited to, limitations on the scope of practice as well as “liquidations, injunctions, and forfeitures.”7  
    • Administrative fines or citations, as well as corrective action plans, do not need to be reported unless 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.  
  1. So, under the Final Rule, is it possible that just a “negative finding” on a state licensing survey of a hospital or health care entity would be reportable to the NPDB? Does the answer change if that hospital or health care entity has submitted a corrective action plan?

The negative finding may be reportable to the NPDB, but keep in mind such negative finding must first be the result of a “formal proceeding” held before the state licensing authority. The answer also depends on whether the state licensing survey would be publicly available under state law. Also, under the Final Rule, an administrative fine or a corrective action plan is not reportable to the NPDB, unless it was connected to the delivery of health care services or taken in conjunction with another action such as a revocation, suspension, censure, reprimand, probation or surrender.8 So, if a negative finding is the result of a formal proceeding (e.g., the hospital appealed its survey findings and a hearing was held), it may be reportable to the NPDB—depending on state law and whether the reporting entity (here, the state licensing authority) considers a “formal proceeding” has taken place.

Keep in mind the Final Rule does not just require the reporting of a “final” finding—if the finding is reportable, the report will be made and a revision or correction to the NPDB report can be made later.9  

  1. Who is responsible for submitting a report to the NPDB about a hospital or health care entity? Does a hospital or health care entity have to self-report to the NPDB?

Only the entity that takes a reportable action (such as a state licensing authority or a Private Accreditation Entity) must report it to the NPDB; the hospital or other health care entity that is the subject of the reportable action does not report it.10 Hospitals and other health care facilities are not required to report their own accreditation recommendations.11

  1. How will a hospital or health care entity know it has been reported to the NPDB and is it possible to dispute such a report?

When a report is made, the NPDB will automatically send a copy of the report to the subject (including a hospital or other health care entity). The report will be free of charge. A hospital or other health care entity can dispute the report but certain time deadlines and procedures apply.

  1. If a hospital or other health care entity is reported to the NPDB, what information is reported?

Whether it is a licensure action taken by a state licensing authority or a negative action/finding taken by a Private Accreditation Entity, detailed information must be reported to the NPDB, including the hospital or other health care entity’s Federal Employer Identification Number, the National Provider Identifier issued by CMS, a narrative description of the acts or omissions and injuries, a reporting code and the date the action was taken, its effective date and duration.

Keep in mind the following information may be reported about a hospital or other health care entity as part of the NPDB report: Medicare/Medicaid provider numbers, CLIA numbers, FDA numbers, DEA registration numbers, the names and titles of the entity’s principal officers and owners, the names and addresses of any health care entity with which the subject of the NPDB report is associated or affiliated, and the nature of the subject’s relationship with each associated or affiliated health care entity.

  1. Could a state licensing board’s private reprimand to a physician be reportable to the NPDB?

Possibly, if a private reprimand was publicly available and was the result of a “formal proceeding.” Unfortunately, the Final Rule’s definition of what is a “formal proceeding” is broadly written and somewhat vague. In some jurisdictions, a licensing board’s private reprimand would not constitute “disciplinary action” and would not be publicly available. (However, in commentary, HRSA stated a voluntary surrender of license could be reportable even if the surrender was based on information that was not publicly available.) Also, it remains to be seen how the Final Rule will interact with state laws that specifically protect certain information, including licensing board proceedings, as privileged.12  

HRSA stated in commentary that whether a “formal proceeding” had occurred would vary from state to state, and could be an issue for secretarial review during the NPDB’s dispute process.13  

  1. What new information will now be available from the NPDB beginning March 1?

Under the Final Rule,14 NPDB queriers will now have access to:  

  1. State licensure actions taken as a result of formal proceedings, which means:  
  1. Any adverse action taken by a state licensing authority against a health care practitioner, hospital or other health care entity as a result of formal proceedings, including revocation or suspension of a license, reprimand, censure or probation;  
  2. Any dismissal or closure of the formal proceeding by reason of a health care practitioner, hospital or other health care entity surrendering the license, or the practitioner leaving the state or jurisdiction;  
  3. Any other loss of the license by a health care practitioner, hospital or other health care entity, whether by operation of law, voluntary surrender or otherwise;15 or  
  4. Any negative action or finding regarding a health care practitioner, hospital or other health care entity.  
  1. Peer Review Organizations and Private Accreditation Entities’ negative actions or findings taken as a result of formal proceedings against health care practitioners, physicians, dentists, hospitals and other health care entities, which means:  
  1. A Private Accreditation Entity’s final determination of denial or termination of an accreditation status that indicates a risk to patient safety or quality of health care services; and  
  2. Any recommendation by a Peer Review Organization to sanction a health care practitioner, physician or dentist.  

The NPDB will now have information about adverse licensure actions taken against health care practitioners and entities that were reported to the Healthcare Integrity and Protection Data Bank (HIPDB) as of February 28, 2010. (By cooperation of state agencies, that information has been placed in the NPDB and will be available March 1, 2010.)16  

Under the Final Rule, the information now reportable to the NPDB by state licensing authorities, Peer Review Organizations and Private Accreditation Entities will include information for actions taken as far back as January 1, 1992.17  

  1. If Peer Review Organizations have to report negative actions/findings to the NPDB, does this reporting requirement apply to hospital peer review committees?

No. The new NPDB reporting requirement for “Peer Review Organizations” only includes “stand-alone” peer review organizations and does not apply to “internal peer review committees of hospitals, professional societies, or other health care entities.”18 Also, a Patient Safety Organization (PSO) is not considered a Peer Review Organization under the Final Rule since the PSO will be enhancing a culture of patient safety rather than taking NPDB-reportable actions.19  

  1. Is it true that law enforcement will be able to check the NPDB, including checking for information about a hospital or other health care entity?

Yes, but they will only have access to certain information regarding individual health care practitioners, physicians, dentists, hospitals and other health care entities, as follows: 1) adverse actions taken by state licensing authorities; and 2) negative actions and findings taken by state licensing authorities, Peer Review Organizations or Private Accreditation Entities.

The law enforcement officials and agencies now authorized to query the NPDB for this information include the U.S. Attorney General, U.S. Chief Postal Inspector, U.S. Inspectors General, U.S. Attorneys, U.S. Comptroller General, U.S. DEA, U.S. Nuclear Regulatory Commission, FBI and state law enforcement agencies.20 However, these law enforcement officials and agencies will not have access to adverse action or medical malpractice reports in the NPDB.21 Just like the other federal and state agencies that now can query the NPDB as of March 1, law enforcement may query the NPDB for the following purposes: “determining the fitness of individuals to provide health care services, protecting the health and safety of individuals receiving health care through programs administered by the requesting agency, and protecting the fiscal integrity of these programs.”22

  1. Do you have any good news for me about this Final Rule?

Yes. There are at least three pieces of good news.

First, because the NPDB will now contain information about health care practitioners as reported by state licensing authorities, Private Accreditation Entities and Peer Review Organizations, the NPDB will be a more valuable resource of information for a hospital to query regarding any health care practitioner who applies for privileges or staff membership at the hospital, or who seeks employment or affiliation with the hospital.

As before March 1, hospitals must query the NPDB when a physician, dentist or other health care practitioner applies for a position on the medical staff (courtesy or otherwise), or applies for clinical privileges at the hospital. Hospitals must also query the NPDB every two years concerning any physician, dentist or other health care practitioner who is on the medical staff (courtesy or otherwise) or has clinical privileges at the hospital.23

Second, under the Final Rule, entities that must report information to both the NPDB and the HIPDB will now have to file only one report per action, instead of two, to the Department’s web-based system.24 Third, while the NPDB regulations still permit an attorney or a patient representing himself to request information from the NPDB as part of a medical malpractice suit, the Final Rule did not change the broad restriction that such attorney or patient can only receive NPDB information upon evidence showing the hospital did not query the NPDB.25

Conclusion

Alston & Bird LLP stands ready to assist hospitals, health care entities and others in grappling with the consequences of this Final Rule. The importance of good preparation for licensure and accreditation surveys; coordination with state licensing authorities, Private Accreditation Entities and Peer Review Organizations; deciding whether to pursue formal proceedings with those organizations to challenge their actions and findings; and working with the NPDB to correct or dispute reports cannot be underestimated. If we can assist you with any of these activities or with questions regarding the Final Rule, please let us know.