The Massachusetts Medical Society appreciates the
opportunity to provide comment on proposed changes to the “Licensing and the
Practice of Medicine” (243 CMR 2.00) regulations of the Board of Registration
in Medicine. The Medical Society has strong concerns about several changes
proposed herein, and suggests modification as detailed below, to ensure the
regulations promote the best interests of the patients of Massachusetts.
The Medical Society reminds the Board that this ongoing
regulatory review 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 license application requirements, by
increasing administrative burdens of physician offices through expanded record
retention requirements, and by consistently expanding the scope of authority of
the Board in its licensing determinations- all of which are antithetical to the
underlying Executive Order.
Expansion of the Purpose of the Board
The Medical Society opposes changes to Section 2.01(1),
which expand the purpose of the Board beyond its current long-standing charge,
to ensure that only qualified physicians are licensed to practice medicine in
the Commonwealth, to include guaranteeing subjective characteristics, competency
and good moral character, for the physicians it licenses. The purpose of the
Board has traditionally been to ensure that applicants meet the extensive,
detailed, impartial qualifications set out in these regulations and in its
detailed, specialized licensure applications. This charge, to certify qualified
physicians, provides vital protections for the public, for physicians, and for
the Board, as the standards for fulfilling this charge are ratified by extensive
regulations and guidances, developed by unbiased experts with oversight from the
Department of Public Health and other relevant state officials. Adding determinations
of “competency” grossly expands the scope of the Board, and, without a clear definition
or explanation of the standard for this charge, fails to establish a structured
and predictable set of expectations. It is unfair to presume and mandate that
Board members can and should be responsible for determining the competency and
good moral character of every physician from the information contained in the licensure
application. Instead, we should continue to rely on the many years of thoughtful
guidance, training, and observation from qualified faculty medical experts who prepare
residents and physicians for high-quality, individual care of patients “within clinical
learning environments for development of the skills, knowledge, and attitudes
necessary to take personal responsibility for the individual care of patients.”[1] It
is through these many years of carefully designed educational and training
programs with expert physicians that thorough and accurate evaluations of
competency and moral character are developed.
The Medical Society shares the Board’s mission, we also want
all licensed physicians in Massachusetts to be competent clinicians. However,
this noble end is currently imbedded in the current licensure qualifications of
the Board regulations, carefully designed and updated by expert clinicians,
experts, and officials, to evaluate competence. Many of the objective
requirements for licensure contained in these regulations are designed to
ensure competency and good moral character from documented observations during medical
education, professional examinations, and post-graduate medical training, which
of course has strict, standardized curriculum that ensure competency as a
condition of passage. The Medical Society urges striking the addition of
“competency” from Section 2.01(1), and instead, suggests the Board continue to
imbed qualifications within the regulations and licensure applications that
promote assurances of competency.
Inclusion of “Good Moral Character”
The Medical Society opposes the addition of a dozen new
references to “good moral character” in these regulations, including an
addition in 2.02(1)(b) that implies a shift in the burden of proof to the
applicant to provide evidence of their good moral character. The Medical
Society has long accepted that a qualification for physician applicants is good
moral character. We believe that the current, longstanding references to this
as part of the licensure qualifications is more than sufficient. The Medical
Society oppose adding this determination of “good moral character” to the
general purpose to of the Board in Section 2.01(1), and opposes the addition of
this reference in a dozen other portions of these regulations.
Good moral character is not defined in the regulations, and
this is likely do to the difficulty of creating such a definition. But this
difficulty in defining the term is also the source of the concern by the Medical
Society. One person’s definition of good moral character can easily differ from
that of another. The Medical Society believes that the better approach to
promoting this end is to ensure adherence to the rigorous licensure
qualifications put forward by this board, and laws and regulations pertaining
to the practice of medicine, which imbed in them so many ethical best
practices.
With all of these concerns regarding the determination of good
moral character, the Medical Society strongly opposes the apparent shift in the
burden of proof of good in Section 2.02(1)(b) by requiring every applicant to
“provide satisfactory evidence” of good moral character. The Medical Society
believes that this shift to now require affirmative proof of the good moral
character is unnecessary, and again difficult to interpret given the lack of
definition.
Prohibition of the Delegation of Medical Services to non-licensed Individuals
The Medical Society strongly opposes the proposed
prohibition of delegation of medical services by physicians to non-licensed
individuals in Massachusetts. Medical assistants, for example, are not licensed
in Massachusetts. They assist in medical care exclusively under the delegation
authority of these regulations. The regulations, as currently in effect,
provide strong safety and quality protections by requiring, 1) that all
services be within the skill set of the person to whom the service is
delegated, and 2) that the responsibility and liability of the delegate
ultimately lies with the delegating physician. The broad definition of
“practice of medicine” means that many common procedures such as the taking of
blood pressure are considered to be the practice of medicine. Prohibiting
physicians’ ability to delegate such a service to a medical assistant—who does
not have the ability to become licensed in Massachusetts—would substantially
disrupt health care delivery in the state, and would drive up costs
unnecessarily by requiring work to be performed by overqualified individuals.
The Medical Society urges retention of the original regulatory language, and
suggests that if specific instances of delegation are of concern, that the
Board utilize the current regulatory protections, or that it consider adding
select “non-delegable services” to the regulations
Medical Record Retention, Password Requirements
The Medical Society opposes the extension of the medical
record retention requirement in 2.07(13) from seven to ten years. A recent
survey of state laws across the country, with an emphasis in this geographic
region, shows 5-7 years is still the predominant requirement. The Medical
Society urges retention of the seven year requirement for physician offices,
and believes that an arbitrary extension is inconsistent with the underlying
Executive Order, and that it unnecessarily burdens physician offices,
especially in light of security concerns which have driven up the cost of
secure record storage.
The Medical Society also strongly opposes section (f) of
2.07(13) which would require physicians to provide to their executors or
administrators passwords for all medical records. Assuming that many executors
are not “Business Associates,” there is significant concern that this could
lead to the regulations requiring actions that breach HIPAA. The Medical
Society urges removal of this section until a better solution is crafted.
Elimination of
Physician Health Services Exemption for Substance Use Disorder
The Medical Society was dismayed to see, and strongly
opposes, the removal of the longstanding substance use disorder exemption in
2.07(23), which has long been a critical avenue for physicians to proactively
seek help through a qualified program, such as Physician Health Services. It
has allowed physicians with alcohol use disorder or substance use disorder—so
long as there has not been a breach of BORIM regulations or any allegation of
patient harm—to seek treatment without report to the Board, so long as the
physician is compliant with the treatment program. The addition of “violation
of Ch. 94C,” the state’s drug laws, to the list of conditions that exclude
participation via this pathway, will effectively gut this provision, as
physicians will have violated these laws by nature of their misuse of drugs. This
proposed change will not allow for those with substance use disorder to
proactively seek treatment without report to the Board.
The Medical Society has engaged with the entire Baker
administration over the past two of years to engage in a campaign to reduce
stigma and to encourage treatment of all persons with opioid use disorder. We
all know that physicians are not immune to this disease. We thus strongly urge
the Board to retain the full “PHS exemption” by striking the reference to
violations of Ch. 94C to ensure that physicians are encouraged to get help,
especially in instances where other Board regulations have not been violated,
and where there have not been instances of patient harm. Eliminating the
exemption for those with substance use issues, and not for those with alcohol
use disorders, has the potential to perpetuate stigma and fails to promote the
notion of opioid addiction as a disease.
Addition of Cancer Treatment Disclosure Requirement
The Medical Society opposes the addition of section (14) to
2.07, which adds new requirements for the disclosure of a host of information
for every patient who accepts treatment for a known or suspected cancer. The Medical
Society of course supports fully informed decisions by patients, but believes
that laws and regulations are already in place to promote and ensure fully
informed consent. Massachusetts law requires that “a physician owes his [or
her] patient the duty to disclose all significant medical information that the
physician possesses, or reasonably should possess, which is material to an
intelligent decision by the patient whether to undergo a proposed procedure.” Harnish v. Children's Hosp. Med. Ctr.,
387 Mass. 152, 155 (1982). In light of the robust informed consent protection,
the Medical Society opposes the addition of this section which pertains solely
to cancer treatments. We further oppose the explicit lists of what must be
required in these cancer-related disclosures of “alternative methods”, as well
as the language regarding physician obligations for information regarding consultations.
The Medical Society opposes the approach of “diagnosis
specific” regulatory provisions, and fears that this indicates exceptionalism
of cancer diagnoses and treatments from those of many other disease types.
Further, the specificity of the requirements in this section are inconsistent
with the legal and regulatory oversight of the rest of the practice of
medicine. Again, broad informed consent and standard of care requirements have
long provided sufficient tools to make ensure proper disclosure of medical
information to patients, and the Medical Society urges the Board to strike this
new provision and rely upon existing informed consent laws.
Addition of
Informed Consent Language
The Medical Society again opposes the addition of the
informed consent language to 2.01(26). The Medical Society opposed this
language in the Patient Care Assessment portion of the Board regulations, and
again opposes the language for the same reasons, in part as excerpted below
from our previous testimony:
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.
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.
Removal of
Liability Protections for Sponsoring Physicians
The Board has long had a rarely used licensure category to
allow physicians to seek temporary Emergency Restricted Licenses in
Massachusetts if they have been displaced from their medical practice or
medical training by a federally-declared disaster. We support this licensure
category as a compassionate service to other physicians in times of great
difficulty. Part of the regulatory requirements for these physician applicants
is that they have a Massachusetts licensed physician sponsor. This sponsorship
may be important to ensure that the displaced physician has a relationship with
a Massachusetts physician so to ensure a basic network in Massachusetts
medicine. Being these are licensed physicians in other states, there are no
requirements of supervision or oversight by the sponsoring physician. For these
reasons, there has also been a longstanding provision in the regulations
explicitly indicating that sponsorship does not imply liability for the actions
of the physician for whom they are sponsoring. The striking of this liability-limiting
language will increase impediments for displaced physicians, and is an
otherwise unjustifiable attempt to expand liability exposure for physicians who
are simply trying to help out a colleague in need during difficult times. The
Medical Society strongly opposes the removal of this language.
Retention of the
Seven-year Rule
The Medical Society opposes the retention of the seven-year
rule. In fact, the Medical Society now has policy encouraging the elimination
of the United States Medical Licensing Exam Step 2 Clinical Skills Exam for
licensure requirement for graduates of U.S. osteopathic and allopathic medical
schools who have passed a medical school-administrated clinical skills
examination. The Medical Society urges the amendment to the licensing
regulations to reflect this policy that was passed amidst growing concerns that
the exam is costly, redundant, and not associated with evidence that it proves
clinical competency.
Addition of
Several Factors for Waivers of Substantial Equivalency
The Medical Society opposes the additional factors added to
2.03(1)(e) which outlines situations in which international medical school
graduate physicians can apply for waivers to the substantial equivalency of
medical school education. The new factors laid out in section (e) are overly
restrictive and will prohibit many well qualified physicians from practicing or
training in Massachusetts. Specifically, requirement “2” and “3” in paragraph
(1)(e) are very concerning in that they would require any applicant who cannot
show substantial equivalency to first have practiced with an unlimited,
unrestricted medical license in another state for two years. This implies that
Massachusetts is not willing to make the difficult but important determinations
of which physicians, who have completed an accredited residency program, are
able to become licensed in Massachusetts. This could meant that a graduate of a
international medical school that cannot show substantial equivalency, but who
completed a US residency, and practiced in Canada for several years, cannot be
considered for licensure in Massachusetts. The Medical Society firmly opposes
the concept that graduates of international medical schools who cannot show
substantial equivalency but who completed accredited residencies are per se
barred from application in Massachusetts until they have practiced in another
state for two years.
The Medical Society also opposes the requirements put
forward in 2.03(2)(e) which place similar requirements on applications of
waivers for substantial equivalency for limited license applications. Here, the
permissive requirement that applicants have held an unlimited license for 2
years in another is completely illogical and untenable as the applicant is
simply applying for a limited license to participate in a residency program. By
nature of their application for a limited license, they could not and would not
have practiced with an unlimited license in another state.
Inclusion of
Malpractice and Criminal History into Application Requirements
Lastly, the Medical Society strongly opposes paragraphs 9
and 10 of Section 2.04 which add malpractice and criminal history requirements.
They both are overly burdensome, unfounded expansions of the minimum
requirements for licensure applications. The requirement in (9) of
documentation of “any malpractice claim in which he or she was involved” is
overbroad and burdensome to applicant. The Medical Society was recently in
touch with a mid-career applicant from out-of-state who was a party to two
malpractice suits as a resident. In each instance, he was quickly dropped from
the case with no payment, settlement, or decision on the merits of the case.
The plaintiff’s attorneys realized in each instance that there were no merits
to the inclusion of this physician on the case. But he was forced to spend countless
hours to find the documentation required by the board, all on two cases from
which he was dropped by the plaintiff very early in the process several decades
prior. This section should be amended to only include cases for which a
settlement was payed or for which a judgment was made indicating malpractice.
The Medical Society also firmly opposes the inclusion of
criminal history into the regulatory requirements of the license application.
The term “all criminal proceeds to which he or she was a defendant” is a
drastically overbroad standard that would capture countless instances where
criminal charges were dropped or where applicants were found not guilty. The
justice system in Massachusetts and the country is founded upon the ability to
fully respect the criminal process and the concept of innocence. Should an
applicant who was falsely arrested for a crime and fully exonerated need to
provide such information to the Board? Should an applicant who has had his
juvenile record sealed by the courts be required to provide such information to
the Board?
This overly broad requirement for information implies that
such information could be relevant to the decision of whether to grant an
application. The Medical Society believes this terminology is antithetical to
the justice system in our country, and does not respect due process afforded to
all of its citizens. The Medical Society urges striking of this section.
The Medical Society appreciates due consideration of these
comments, and urges re-evaluation of the regulations in light of these
comments, and those of many other interested stakeholders.
[1] http://www.acgme.org/What-We-Do/Accreditation/Common-Program-Requirements
