Massachusetts Medical Society: BORIM Revisions of 243 CMR 2.00

BORIM Revisions of 243 CMR 2.00

“Licensing and the Practice of Medicine” regulations (243 CMR 2.00) govern the requirements and procedures for applying for licensure and for practicing medicine in Massachusetts. 

The Board of Registration in Medicine (BORIM) recently approved revisions to these regulations that may substantially affect many physicians’ practices.  BORIM initially proposed revised regulations in May 2017.  What was ultimately adopted in July 2019 is an amended version those proposed regulations, which were revised in part based on comprehensive feedback submitted by the Medical Society and other engaged stakeholders. 

Some of the more concerning proposals were either revised or stricken from the regulations altogether.  For example, a proposed section that required disclosure of specific information for patients who accept treatment for known or suspected cancer, including disclosure of alternative methods of therapy, was deleted.  MMS opposed this provision because current laws and regulations promote and ensure fully informed consent without the need to carve out specific regulatory provisions denoting the exceptionalism of certain types of medical care.

The revised regulations took effect on August 9, 2019, so please read on below to see how the changes may affect your practice.

Informed Consent

The new regulations appear to significantly expand requirements for informed consent.  MMS is currently seeking additional guidance to understand the scope of the written informed consent requirements, as it is not clear how broadly these new requirements could apply at this time.  We have conveyed concern that a broad interpretation could slow down routine clinical care and increase administrative burden.  The regulations specifically require attending physicians to obtain and record written informed consent before diagnostic, therapeutic, or invasive procedures and medical interventions or treatments when disclosure of significant medical information would assist a patient in making an informed decision whether to undergo the proposed procedure, intervention, or treatment.  Other healthcare facility personnel may assist with the completion of the informed consent documentation. 

Furthermore, the regulations require physicians to have written policies and procedures to address the written informed consent process.  At a minimum, these policies must discuss the types of procedures, interventions, or treatments for which informed consent is required, along with the content of the information provided; who is responsible for obtaining informed consent from the patient; how the informed consent will be documented; and the circumstances surrounding the times when someone other than the patient can give informed consent.  MMS will work to develop additional guidance on how physician practices can create such policies.

The regulations also require the attending physician to inform the patient of everyone who will participate in a procedure, intervention, or treatment.  The names of all physician extenders must be noted on the patient’s written informed consent form.

Furthermore, the patient’s medical record must reflect any absence of the attending physician, including the times of the attending’s absence(s) and who was the attending physician during the absence(s).

Delegation of Medical Services

BORIM’s revised regulation expressly prohibit delegation of medical services to individuals who are not licensed in Massachusetts to perform the services that were delegated to them.  The departure from the previous regulation, which allowed physicians to delegate to skilled professionals and nonprofessional assistants services that were consistent with accepted medical standards and appropriate to their skill, complicates the clinical care of healthcare assistants who are not licensed in Massachusetts.  Moving forward, it may be important to determine which members of the healthcare team are licensed for what procedures so that clinical procedures may most seamlessly proceed in a manner compliant with these regulations.  MMS is seeking further guidance from the Board on this matter and will share clarifications as we receive them.

Licensure Application/Renewal

BORIM made numerous changes that added requirements to the overall process of licensure application and renewal.  The regulations now require as a condition for initial licensure, licensure renewal, licensure revival, or reinstatement of licensure one-time training requirements for Domestic and Sexual Violence (per M.G.L. c. 112, § 264) and Child Abuse and Neglect (per M.G.L. c. 119 § 51A(k)), in addition to requiring that applicants apply for, or participate in, MassHealth (per M.G.L. c. 112 §§ 2 and 9).  The regulations also now require each applicant for licensure to report all malpractice claims and criminal proceedings in which they were named as a defendant, irrespective of the ultimate disposition of the case relative to the applicant, including cases that were dismissed or in which no guilt or liability was found against the applicant.  Furthermore, the regulations include “good moral character” as requirement for licensure.  This requirement is left undefined, however, and does not state who will make this moral judgment or the process by which it will be determined.

Reporting of Drug or Alcohol Misuse

BORIM also expanded the conditions required to qualify for an exemption from reporting drug or alcohol misuse.  The existing conditions for exemption required having a reasonable basis to believe impairment, having no allegation of patient harm, and confirming compliance with a treatment program.  Now, in order to be exempt from reporting drug or alcohol misuse, the physician whose conduct is in question also must not have violated any law or regulation and must not have been impaired at the workplace or while on call.  Requiring that the physician has not violated any statute or regulation seems antithetical to the goal of the exemption, since any illicit use of a controlled substance would violate the law and therefore require a report.  This requirement would undermine the purpose of the exemption, which is to encourage treatment of physicians while ensuring that any impairment does not pose a danger to patients.  MMS is working with the Board to further amend these changes with the common understanding of the spirit of this exemption.

Miscellaneous

The regulations now mandate specific infection prevention and control measures, including the implementation and maintenance of infection control policies and procedures tailored to the specific healthcare setting and patient population served by the physician.  At a minimum, these policies must address hand hygiene, use of PPE, safe injection practices, safe handling of potentially contaminated equipment or surfaces, and respiratory hygiene/cough etiquette.

The new regulations also mandate that the medical records of a deceased physician be retained—for a minimum of seven years after the date of the last patient encounter—by the executor or administrator of their estate.  These records must be made available for access by patients.

Licensed physicians are required to report to the Board any ownership interest in a for-profit acute care hospital or for-profit health maintenance organization.  Additionally, physicians must report to the Board any ownership interest in physical therapy services.  The regulations lay out the specific details of what information needs to be provided.

The regulations added another adverse event occurring in a licensee’s office that triggers a mandatory report.  In addition to mandating reports for unplanned patient transfers to a hospital and for unexpected patient death not related to the underlying condition or natural causes, licensees must now report to the Board any event of “serious injury” that is precipitated by a treatment or a procedure performed in the licensee’s office setting.  The term ‘serious injury’ is not defined by the regulations.  MMS will continue to seek guidance and clarification on this and all other revised regulations.

Additional Resources

BORIM Executive Summary

243 CMR 2.00

MMS Written Testimony (May 2017)

 
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