COMMENTS
REGARDING PROPOSED REGULATORY CHANGES OF “DISCIPLINARY PROCEEDINGS FOR
PHYSICIANS” (243 CMR 1.00) AND “PATIENT CARE ASSESSMENT PROGRAMS” (243 CMR
3.00)
BEFORE THE BOARD OF REGISTRATION IN MEDICINE
The Massachusetts Medical Society appreciates
the opportunity to provide comment to the proposed regulatory changes of
“Disciplinary Proceedings for Physicians” (243 CMR 1.00) and “Patient Care
Assessment Programs” (243 CMR 3.00) by the Board of Registration in Medicine.
The Medical Society strongly supports the value of a fair adjudicatory process
and of a robust patient care assessment program as key drivers of quality of
care and patient safety in Massachusetts.
The ongoing regulatory review by
the Board of Registration in Medicine is pursuant to Governor Baker’s Executive
Order 592, “To Reduce Unnecessary Regulatory Burden” which mandates a review of
regulations to ensure that they are not unduly burdensome, and that there are
not less restrictive alternatives. The Executive Order instructs that a review
take place to determine if the regulations should be retained or modified to
promote administrative simplification. The Medical Society urges additional
consideration of these proposed changes with a refocus on this underlying
charge, as many of the proposed changes discussed herein actually increase the
administrative burden by expanding definitions of reporting, by grossly
expanding periods of review for physician credentialing, and by consistently
lowering thresholds for what warrants BORIM action- all of which are
antithetical to the underlying Executive Order.
The Medical Society offers the following comment on 243 CMR 1.00, “Disciplinary
Proceedings for Physicians.”
The Medical Society opposes the expansion of the definition of “Disciplinary
Action” as detrimental to the medical education and training of the medical
students, residents, and fellows of the Commonwealth.
The expansion of the definition of
Disciplinary Action under Section 101(2)(c) would sweep into the purview of reportable
events for any given licensee the broad, undefined terms of “remediation” and
“probation, including academic probation.” Combined with Paragraph (b) of this
same section, even “informal, oral” remediation would be considered a
disciplinary action. This overreach and expansion of definition is not just a
proposed regulatory change that is inconsistent with the Governor’s Executive
Order, and which could inconvenience many physicians and overwhelm BORIM staff.
This provision has the opportunity to substantially disrupt the medical
education and training capabilities throughout the Commonwealth, and could
ultimately have detrimental impacts on the training of the next generation of
physicians in Massachusetts.
The practice of medicine is one of
the most complex professions to learn; the stakes of the education to promote
competent care could not be higher. The Board of Registration in Medicine needs
to strike the balance of ensuring that it is privy to material information
about serious “disciplinary actions” while ensuring that medical educators have
authority to engage with students and trainees to facilitate improvement
without fear of undue Board involvement.
Should a residency director who takes time
to help a fellow improve bedside manner or talk about how better to have
end-of-life care discussions be worried that doing so could be considered a
disciplinary action?
Should a surgeon who is working with new
technology and seeks the mentorship of a senior colleague be nervous that this
arrangement could warrant reporting to the Board?
While these example are likely not
consistent with the intent of the Board, they are examples of not-unreasonable
interpretations of the proposed changes given the lack of definitions or
further guidance.
In addition, the Medical Society
strongly supports Physician Health Services (PHS), an organization dedicated to
improving the health of the physicians of the Commonwealth. The valuable
services provided by PHS are often by nature facilitating remediation. A core value
of PHS is that it can be a venue for physicians to proactively seek help with
health concerns before they manifest in actions that traditionally warrant
reporting to the Board.
Should a trauma surgeon seeking help from
PHS for workplace stress and burnout be considered
having been subject to a disciplinary action?
Should a physician with mild depression
seeking consultation with PHS before it affects clinical care be considered to
having been subject to a disciplinary action?
The Medical Society has similar
concerns to the inclusion of “probation” into the list of disciplinary actions.
Medical schools, residencies, and fellowships have robust systems and policies
to promote the best education and training of students and physicians while
also ensuring the highest quality for the patients they serve. They are backed
by strong federal laws, regulations, and accreditation requirements. The
Medical Society strongly urges continued trust and dialogue with these
institutions to develop more thoughtful policies, if needed that do not fall to
simply considering every probation, including informal and/or oral, to be a
disciplinary action. This again contravenes the very tenets of medical
education and training which seek to intervene early and often to create
improvement plans. In addition, a short period on academic probation again
should not be considered a disciplinary action. Often these periods may come
after periods of illness, personal crisis, and/or leaves of absence. A
probation does not necessarily imply poor or failing performance; rather, it
signifies increased attention, support and monitoring for any number of
reasons. The Board should be fostering dialogue and trust with the medical
schools and residency programs within the Commonwealth rather than considering
any action they take to foster improvement and accountability to be a
disciplinary action.
In light of these many examples
that show unintended consequences of the proposed changes, the Medical Society
urges striking these new categories. And while the Medical Society appreciates
that the Board has the discretion whether to act on reported disciplinary
actions, it is important to underscore that all actions by the Board set up a
cascade of other events within the health care system, even if the Board
declines to proceed upon report. The Medical Society appreciates the high
volume of licensing applications and complaints that the Board staff regularly
processes, and urges prioritization to ensure that only categories with
potential to identify truly troublesome events be retained. For these reasons,
we urge striking 1.01(2)(c)15 and 16 from the final regulations that introduce
“remediation” and “probation” to the list of disciplinary actions.
The Medical Society Opposes the Expansion of Grounds for Complaint
The Medical Society is strongly
concerned with the inclusion of “good and accepted medical practice” in the
definition of complaint in 1.01(2), and the striking of “gross” from reference
to negligence in the list of grounds for complaint in 103(5)(a)(3). Each of
these changes reflects a substantial expansion of Board action by including
single instances of negligence or deviations from the standard of care as
grounds for Board complaint. These changes which propose altering the standard
of care for Board involvement are inconsistent with the overarching designs of
the medico-legal system.
Single instances of negligence have
long been dealt with in the civil malpractice arena, with requirements beyond
negligence that include a duty, causation and damages—all in addition to simple
breach of a standard of care. The purpose of the Board of Registration in
Medicine is not to replicate the civil courts and to be the arbiter of a single
mistake over the course of a long medical career. Instead, the Board’s role is
as the protector of the public, as the gatekeeper of those who deserve to be
licensed to practice medicine in Massachusetts pursuant to applicable laws and
regulations. Retention of the current language, which includes as grounds for a
complaint, “gross negligence on a particular occurrence or negligence on
repeated occasions”, reflects the appropriate role for the Board.
The Medical Society also opposes
the addition to the list of grounds for complaint in 103(5)(a)(8) of “conduct
in violation of the ethical standards of the profession.” The Medical Society
strongly supports the highest ethical standards of the medical profession, and
has a Committee on Ethics, Grievances and Professional Standards solely
dedicated to this issue. This committee has developed complex processes and
resources to outline how to respond to concerns that a physician has violated
ethical standards and to promote our code of ethics to physicians, patients,
and the public. A key component of this process is the development and
endorsement of complex Codes of Ethics (the most recent of which put forward by
the AMA surpassed 500 pages) to provide physicians with expectations of ethical
standards to which they may be held. Adjudication of whether a given practice
is consistent with ethical standards without a single word in regulation of
underlying principles or sources of authority is concerning and strongly
opposed by the Medical Society. The complexity and continuing evolution of
the ethical standards of the medical profession necessitate a correspondingly
nuanced definition for and mechanism through which to address violations of
those standards. In the absence of such a definition, the Medical Society fears
that the adjudication of complaints regarding physicians’ alleged violation of
ethical standards will be arbitrary and subjective.
Physician conduct that this
regulation seeks to address will almost certainly meet one or more existing
grounds for complaint outlined elsewhere in this list, the broadest of which being
“misconduct in the practice of medicine” (103(5)(a)(15)). The Medical Society
therefore believes that the addition of “conduct in violation of the ethical
standards of the profession” is superfluous at best, and at worst might cause
harm, for the reasons outlined above.
The Medical Society Opposes the Diminution of Due Process Rights for
Physicians and Trainees
The Medical Society opposes
omission of a timeframe required of the Board for a decision to be issued on a
hearing on the necessity of a summary suspension, as in 1.01(11). These
hearings take place on truncated timelines with limited due process
rights. The results of a suspension of
the license to practice their livelihood warrants, both under a pursuit of
justice and compliance with the Constitution of the United States, a prompt
disposition of the issues. The Medical Society urges a requirement be added for
maximum length for the Board to issue a decision.
In addition, the Board has missed
an opportunity to follow through in its pledges of transparency by still not
acknowledging the physician’s right to a copy of the complaint, an issue that
courts have continually pledged is a right of the physician. The Medical
Society urges reconsideration, and suggests modification of paragraphs outlining
the “Conference” and the “Order for Answering and Answer” in 1.03 to reflect
this right to a copy of the complaint.
The modification of the definition of “Complaint” (in 1.01(2)) which strikes
the prior requirement that a complaint must be “filed with the Board” seems to
remove requirements that the Complaints actually come through the public
complaint process. The Board has a process to file complaints, electronically
or by mail. This process should be respected, and all complaints should have a
modicum of formal process and requirements that come with being filed with the
Board.
Lastly, modification to paragraph
1.03(10) seems to further reflect a move towards a considerable increase in
deference to the Board with no justification or understanding of the practical
implications. The Medical Society urges that such changes to due process
requirements be explained with written justification.
The Medical Society offers the following comment on 243 CMR 3.00, “Patient
Care Assessment Programs.”
The Medical Society strongly opposes the elimination of important peer
review protections for licensed clinics and other non-hospital entities.
The proposed regulations strike
“licensed clinics” and “entities maintaining more than one primary or episodic
walk in center” from the definition of health care facilities eligible for
participation in the Patient Care Assessment Program. While participation in
this program comes with many reporting requirements, detailed below, it also
affords participating entities with important peer review protections. The
Scope and Purpose of these regulations, as outlined in 3.01, is to “ensure
patients receive optimal care” and to “assist physician and health care
institutions in their efforts to identify problems in practice before they
occur and to put in place preventative measures designed to minimize or
eliminate substandard practice.” The goals and purposes as laid out in this
section should not be dependent on the type of licensed facility at which a
physician practices or at which a patient receives care. Licensed facilities
with the infrastructure to participate in this program should have the
protections afforded to them under the current regulations, regardless of
whether they’re a hospital, a clinic or an entity maintaining more than one
primary or episodic walk in center.
The Medical Society opposes the expanded reporting requirements for
participants of the Patient Care Assessment program.
The proposed expansion of serious
reportable events that must be included in quarterly “Safety and Quality
Review” reports is excessive and directly contravenes the Governor’s Executive
Order to reduce administrative burden. The expansion of the “Serious Injury”
category to include non-fatal physical impairments with no reference to “unexpected”
events or regard to other important factors such as comorbidities is an
unreasonable reporting requirement. It does not provide proper deference to
complex presentations of disease and could discourage the acceptance of
patients with high acuity. Reporting of every unanticipated serious illness
will result in an enormous increase in reporting that will be administratively
burdensome for the reporters and for the Board’s Quality and Patient Safety
Committee and staff. If the Board believes that the current requirement of
including all licensed clinics is ultimately too broad, the Medical Society
urges the a compromise that includes the retention of the clinics most likely
to comply with reporting requirements and to utilize the important peer review
protections.
The Medical Society opposes the expanded requirements for credentialing
added to the Patient Care Assessment regulations.
The proposed changes to the
credentialing requirements in 3.05 would substantially slow down the already
burdensome credentialing process while providing little increase in valuable
information to improve the end result. All physicians going through the
credentialing process in Massachusetts are already licensed by the Board; the
credentialing process should not be a duplication of the lengthy and detailed
history that is evaluated by the Board staff. Rather, it should be a
verification of primary credentials and a general evaluation that the physician
is well qualified to provide good clinical care at a given institution. The
change proposed in these regulations that malpractice claims and lawsuits are
not just disclosed to every credentialing committee over the past ten years
year, but instead over an entire career drastically increases the burden of
applicants while only providing outdated, low-value information that
credentialing committees will have a hard time evaluating. The proposed
elimination of the current exemption to report low-level crimes again does not
seem to provide any true improvement in the quality of credentialing but
substantially raises the burdens for every credentialing application. And
again, many of these matters are best left to the Board in their decisions to
provide a medical license.
Finally, the elimination of the
current ten-year limit to the requirement that that credentialing facilities
inquire with every health care facility where a licensee has ever had
employment, practice, or association for his or her entire medical career is
unreasonable. It will add significant time to the already lengthy credentialing
process. This will further contribute to the growing frustrations that many
employers have had trying to recruit physicians from out-of-state. Any benefit
from information gained by such a change is grossly outweighed by the burden it
will place on every credentialing staff in the Commonwealth, and this provision
directly conflicts with the Governor’s Executive Order.
The Medical Society strongly opposes the amendments and additions of
the informed consent provisions.
The Medical Society strongly values
the concept of informed consent as a vital component of respect for patient
autonomy. The Medical Society believes that patients deserve to know material
information about surgery- they should know who is leading the surgical care, and
they should be informed about what components of a given surgery at which the
attending physician will and will not be present.
Massachusetts courts have set forth
standards and tests to ensure that all patients have the right to adequate
informed consent. Informed consent has long been a careful balancing test of
ensuring that the proper level of material information has been conveyed to
patients for any given procedure, and that it is provided in the proper manner
to ensure patients understand the risks, benefits, and alternatives to a given
intervention. Undue burden in policy can also be problematic if it impedes the
delivery of high-quality health care and does not prioritize the disclosure of
the most material information. The Medical Society is concerned that the
present regulations as drafted will have significantly deleterious impacts on
the practice of medicine while providing little additional information of value
to patients.
The scope of application of the
informed consent provisions is overbroad and internally inconsistent. The
detailed written informed consent provisions, which were put forward in
response to issues with the most advanced surgical procedures, have been
written to be broadly applicable to any and all “diagnostic, therapeutic or
invasive procedures, medical interventions or treatments.” The redlined
regulations seem to imply that modifying this list with “major” was
contemplated, but ultimately ignored. In other words, these provisions could
have been limited to “major surgeries and procedures,” but the regulations
proceeded with the broadest possible application. Again, written informed
consent makes good sense in a number of clinical scenarios, primarily those
dealing with major surgery or treatment. But at present, as drafted, all of the
written informed consent provisions contained in these proposed regulations
would apply to every diagnostic or therapeutic action.
In the course of standard primary care
visits, would separate, written informed consent need to be obtained for a
strep test, for a blood draw, for an impacted fingernail, for an antibiotic
treatment, and for a sling?
The scope of application of the
informed consent provisions is also inconsistent within the regulations.
Whereas 3.10(1) provides limits to the informed consent requirement, paragraph
(c) of the same section modifies the extent to which the informed consent
provisions apply to only those where the information would assist a patient in
making a decision whether to undergo the proposed procedure.
The details of what is considered
adequate informed consent are problematic and do not comport with the health
care delivery model in place in Massachusetts for many surgeries and procedures
swept into these regulations. First, requiring the attending physician to
obtain every written informed consent is not tenable and does not necessarily
promote the best care for the patient. Many surgical teams elect to obtain
written informed consent at the pre-operative appointment, as patients are
often in a better position to comprehend the information and to ask questions,
without being overwhelmed with the anxieties of an impending procedure. Often,
this pre-operative appointment may be led by a physician or other provider that
is not the attending physician. This may be because the attending physician is
called into an emergency, or it may be because another team member is the most
skilled communicator or has a pre-existing relationship with the patient. In
teaching and training settings, it is important to allow fellows to participate
in every aspect of the surgical process from providing informed consent to
providing discharge instructions and handling follow-up care. While it is
important that the attending physician be available for questions, requiring
the attending physician to obtain the written informed consent for every
procedure is not feasible nor does it promote the best interests of the
patient.
The requirement that the attending
physician inform the patient at the point of written informed consent the names
of all “physician extenders” is infeasible and again does not provide the most
material information to the patient. First, the nature of surgical programs,
especially those in academic medical centers, is that surgical care teams can
be fluid and shift at a moment’s notice. A roster of participants of surgeries
for a given operating room prepared at the beginning of a day can be
substantially altered based upon unexpected emergency surgeries, illness of
surgical team participants, and the educational priorities of residents and
fellows. Complications during surgery are by nature unpredictable- surgeons
should not be constrained in calling in colleagues for consultation or
collaboration. Lastly, complex surgery can be a grueling physician exercise for
the surgical team. They should be encouraged to take breaks and to call in
support when necessary. The detailed requirements in the informed consent
provisions do not take into account many of these important details.
The Medical Society greatly
appreciates the opportunity to provide detailed comment regarding these
regulations. We urge reconsideration based upon the comment provided herein.
