On October 28, 2016, the Department of Health and Mental Hygiene ("DHMH") published its final regulations regarding hospitals' and certain other health care facilities' obligations to report certain actions involving physicians, allied health providers and naturopathic doctors. The final regulations are codified at COMAR 10.32.22 and became effective November 7, 2016.
As you may recall, these regulations are in response to historically low reporting by hospitals of certain actions taken against physicians. Prior to these regulations, the Board of Physicians was advocating that all changes to a physician's privileges, regardless of the nature of those changes, should be reported to the Board of Physicians to determine whether the Board should take further action. The new regulations are intended to provide better guidance as to when an action should be reported to the Board.
As an overview, the regulations require reports when there is a "change" with respect to a health care provider licensed by the Board (other than athletic trainers) who is employed, contracted or granted privileges. The "change" definition includes terminating or not renewing staff privileges, employment or contracts; taking disciplinary action including suspension, placement on probation or restriction/limitation of privileges; accepting an involuntary resignation, certain leaves of absence or alternations in practice; terminating a "health care staff company" (a company that provides health care services); and denying an application for privileges. The regulations further define 15 areas that result in a reportable change and provide clarification as to what is not reportable.
The list of 15 areas includes some matters that are different from what has been traditionally reportable pursuant to the underlying Maryland statute relating to mandatory reporting, although item number 15 includes all those matters currently reportable. The new matters include changes due to:
- Providing patient care of questionable quality. Previously reporting was required for conduct that "failed to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care."
- Disrupting the workplace. Current statutory reporting requirements cover "unprofessional" and "immoral" conduct; however, "disruptive workplace conduct" is probably somewhat broader.
- Committing "unethical" conduct. There are several actions that currently require reporting that would undoubtedly come under the general description of "unethical" conduct such as promoting sale of drugs or devices to patients for financial gain, paying for referrals, over utilizing health care services, treating by "secret" methods and several others. However, the regulations now seem to lump all of those under "unethical."
- Committing billing or coding fraud. Current reporting requirements include filing a false report or record in the practice of medicine, fraudulently using a license and being convicted of insurance fraud; however, generic "billing or coding" fraud is somewhat broader.
- Suffering from a physical, a mental or an emotional condition or impairment that affects the health care provider's ability to perform the individual's medical or surgical duties. Current reporting requirements include being physically or mentally "incompetent" and providing services while under the influence of drugs or alcohol. However, the regulation is somewhat broader and notably requires reporting of a physical, emotional or mental condition even if the practitioner did not engage in the practice of medicine while suffering from the condition.
- Not complying with the requirements of an alcohol or a drug treatment program. This is an entirely new requirement not contained in the statute.
- Repeatedly failing to complete medical records. This is somewhat broader than current law, which requires reporting failing to file or record a medical report "as required by law." Also, this requirement raises the question of what is meant by "repeatedly."
- Repeatedly violating hospital bylaws, rules, policies or procedures after warning. This is an entirely new requirement not currently in the reporting statute.
Remember, a report is only required if there is a "change" due to one of these 15 items, not simply because one of the 15 items occurred.
Areas not required to be reported include voluntary leaves of absence if the practitioner is in good standing, meaning the practitioner is not on probation or subject to any pending disciplinary proceeding. The regulations give examples of non-reportable leaves of absence, including but not limited to maternity leave, family problems of a medical or personal nature, sabbaticals and extended vacations. Of particular concern regarding "leave of absence" is that the definition includes a "hiatus" that was "self-initiated." Therefore, if you approach a practitioner in an informal manner to discuss recent complications in the operating room and the practitioner agrees to not exercise those privileges while the external peer review is pending, such a voluntary agreement would constitute a "hiatus," which would be reportable. Moreover, even if the practitioner elects on his/her own to not exercise privileges while any matter is being reviewed, that unilateral decision would be reportable.
Many medical staff bylaws contain leave of absence definitions and the related implications of taking a leave of absence. Under these new regulations, a leave of absence is defined more broadly and simply agreeing not to perform surgeries for a period of time could be considered a leave of absence.
Similar to a voluntary leave of absence, a report is not required if the provider voluntary resigns while in good standing, for reasons such as a job or career change or the desire to relocate from Maryland or retire. Finally, a report is not required for a voluntary alternation if the practitioner is in good standing, and the change relates to situations such as a switch from active to consult medical staff category, reducing workload or altering a specialty or scope of practice.
An involuntary alteration in practice is not reportable if it: is the result of an FPPE or focused review; does not last more than 90 days in a calendar year itself or combined with another involuntary alteration; or requires additional training or monitoring or completion of certain skills/activities/procedures within a defined period of time. Therefore, if you require a doctor to complete six procedures with a proctor presence within 90 days, that would not be reportable to the Maryland Board of Physicians. However, if you require a proctor to be present to perform the six procedures, the National Practitioner Data Bank ("NPDB") would consider that a restriction on privileges that if it last longer than 30 days would be reportable to the NPDB.
Another exception from the reporting requirements relates to administrative suspensions. The Board does not require a report for certain administrative suspension if they do not cumulatively exceed 30 days in any one calendar year. Therefore, if you administratively suspend a practitioner for not getting a flu vaccine, not completing medical records or not completing EHR training and such suspension lasts more than 30 days, it would be reportable. This type of required report is different than what the NPDB requires. The NPDB would not require a report of an administrative suspension regardless of how long it lasts.
The new regulations also provide for specific reporting requirements relating to naturopathic doctors and allied health providers. With regards to naturopathic doctors, a report is required by a hospital, health care facility or other licensed health care practitioner if they believe a naturopathic doctor is medically or legally incompetent, engaging in the unauthorized practice of naturopathic medicine, guilty of unprofessional conduct or mentally or physically unable to engage safely in the practice of naturopathic medicine.
With regard to allied health providers, a report is required by an entity that employs an allied health practitioner, not just hospitals or licensed health care facilities.
Moreover, a report is required within 5 days of terminating a physician assistant if the termination is due to quality of care issues and within 10 days if the delegation agreement is terminated.
What does all this mean?
The reporting requirements for hospitals have remained largely unchanged although there are now certain nuances that need to be recognized. For example:
- Being under investigation or subject to an inquiry or the subject of a complaint does not require a report, but a report is required if there is a "change" in physician's privileges or practice after being notified that a complaint has been filed with the Hospital or that an "inquiry" or "investigation" has been initiated.
- A report will be required if a physician voluntarily, whether in response to a request or on their own initiative, elects to not exercise their privileges while and inquiry or investigation is being conducted.
- Termination of a contractual relationship with a practitioner may require a report to the Board if related to conduct that may be covered by one of the 15 reportable events.
- Being placed on an FPPE, in itself, does not require a report but a resignation or surrender of privileges while on an FPPE does.
- By including a change in "duties" under the general definition of "changes" raises the question as to whether certain actions, such removing someone from an on-call roster, is now a change in privileges that is reportable.
The above list is hardly exclusive but addresses some common situations you may encounter. Given the nuance of these changes, you will need to analyze every change in practice or privileges to determine whether a report is required.
In summary, the new regulations impose broader and in some cases inconsistent reporting obligations that those required by the NPDB. We would recommend that hospitals review their medical staff bylaws, rules, regulations and policies to ensure that they are consistent with the new reporting regulations. In addition, medical staff and administrative leaders should be made aware that even casual, informal discussions with medical staff members relating to practice issues or complaints now can unintentionally cause a report to be filed if such discussions are followed by a "change" in the practitioner's practice or privileges. To the extent facilities have a peer review or FPPE policy, we would recommend reviewing the language to ensure that the policy does not indicate a report will not be made when it would now be required under the new regulations.