“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)
