Before the Board of Registration in
Medicine
The Massachusetts Medical Society (MMS) supports the Board and
its staff for the comprehensive approach they are taking to their
regulatory changes. The new proposals are much better organized
than the existing regulations and should be easier to comprehend
and for future Boards to consistently apply. The MMS offers the
following comments in an effort to support the monumental task at
hand in this rewrite and to craft a clear, fair and progressive
template for the Board's work for years to come. Now for the
specifics.
Change of Status
The MMS supports language in change of license status
which makes it clear that changes to administrative licenses are
voluntary and initiated by the licensee. The MMS opposes
involuntary changes of classification of full licensees outside the
scope of the disciplinary process.
Facility Definition
The MMS objects to the definition of a health care
facility to include "any location where medicine is practiced".
There is a long standing legal definition of health care facility
to mean a facility licensed by the Massachusetts Department of
Public Health. Physician offices have always been exempt from
restrictions on the practice of medicine outside of licensed
facilities. This definition change blurs an important distinction
and has implications throughout the proposal. Provisions applying
this definition only to this section of the regulations contribute
to the confusion. The line between offices and facilities is, and
has been, difficult to recognize in some cases. However, most
physicians practice in small groups and offices that in no way have
the resources or create the risks associated with licensed
facilities. This definition should be eliminated and requirements
applying wherever medicine is practiced should be specified
directly.
License Definitions
The definition of a license includes four categories while
elsewhere the regulations list twenty categories.
Licensing Committee
The Licensing Committee definition contains no specifics
regarding membership or responsibilities. Its language is entirely
permissive in what the committee may do in response to a license
application but nothing regarding what it must do. No criteria are
set for determining what grounds would trigger various reviews or
restrictions at the committee's discretion. The MMS supports the
work of the Board in licensing only qualified physicians but
suggests that some guidance and criteria be established for
composition of the committee and for guiding its decision
making.
Majority Vote
The definition of a majority vote of the Board is flawed
in that it makes no reference to a quorum.
e-Health
The draft includes a definition of the Massachusetts
e-Health Institute. However, the institute never appears in the
regulations' substantive provisions.
Personal Information and Data
Personal Data and Personal Information are defined in ways
that do not clarify exactly what information is anticipated to be
public and what is not. Also the distinction between the two is not
clear. While it would be difficult to exhaustively lay out in
regulations exactly what information the Board considers to be
confidential and from whom, some clarification would prevent future
individual actions seeking to obtain or protect such
information.
Physician Reentry
Physician reentry is defined as a nondisciplinary action
in returning to active clinical practice after two or more years of
clinical inactivity. How is the Board to determine when "clinical
inactivity" commenced? This wording lacks clarity and should be
amended to apply only to individuals with an inactive license
status. Evidence is needed to show that two years is a period with
clinical significance.
The Practice of Medicine
The definition of the practice of medicine is improved
over the existing definition by the inclusion of modern issues such
as telemedicine. However, it does not address the issue of whether
utilization review is or is not the practice of medicine. The Board
does find medical examinations to be the practice of medicine even
though these often do not involve treatment recommendations and the
physician is not the patient's advocate but an employers. Why then
not include an insurance reviewer where the physician is
recommending a course of treatment and is in fact paid by premiums
of the patient or paid on behalf of the patient?
The Board retains the existing prohibition on use of the initials
M.D. and D.O. but also includes the assumption of responsibility
for the patient. This language is archaic and difficult to prove.
The Board should prohibit the use of the term physician as well as
the initials above. MA law clearly limits such use. The Board
should make efforts in its regulations to empower it to initiate
legal action against all who impersonate physicians or practice
medicine in any form without specific legal authority.
Reinstatement
The Board equates reactivation of a license with
reinstatement. Reinstatement implies that the license was revoked
or suspended where reactivation does not. The Board may wish to
clarify this distinction. The Board also allows discretion to
itself on restrictions on reinstatements. As in other areas of the
regulations, some guidance may be appropriate regarding the
triggers for such actions. Chapter 112 contains the following
requirements. The certification of registration of any physician
who does not file a completed renewal application together with the
fee shall be automatically revoked, but shall be revived upon
completion of the renewal process.
Risk Management Program and Risk Management Study
The definition of a risk management program is defined
solely in terms of the Board's patient care assessment (PCA)
program. There is a legal reason for this as risk management
requirements are the main statutory basis for the PCA regulations.
Clearly most programs in risk management, whether for CME's or as
part of establishing clinical standards, are not PCA programs. The
two definitions should be merged and clarified. Pain management
should be listed as a risk management program as well.
Telemedicine
The Board is to be commended for its definition of
telemedicine as applying to the diagnosis and treatment of patients
within the state whether by local or distant physicians. Does this
definition mean that the Board considers itself lacking
jurisdiction on a physician practicing telemedicine from a
Massachusetts site on a patient with no Massachusetts contacts?
Section 2.02 Licensing
This section is well organized to quickly identify
licensing requirements. Unfortunately over the years, the
legislature has mixed the statutory requirements in the general
laws (MGL Chap. 112) for issuing a license (Section 2) and the
disciplinary action requirements (Section 5). The Board has done
well to try to keep these roles separate but some ambiguity still
exists.
Good Moral Character
As noted in previous testimony over the years, good moral
character is difficult to define and document. This is one of the
few elements included beyond education and training in MGL Chapter
112 Section 2 so the Board is correct to include it in the
application requirements.
Malpractice Coverage
Chapter 112 Section 2 mandates liability coverage as
follows: "The board is authorized to promulgate regulations
requiring physicians to obtain professional malpractice liability
insurance or a suitable bond or other indemnity against liability
for professional malpractice in such amounts as may be determined
by the board." The proposed regulations omit the bond option which
the statute requires.
Pain Management and Electronic Health Records
The MMS recognizes that the Board has little discretion in
these requirements which are imposed by the legislature. We
appreciate the efforts the Board has made to allow compliance where
possible. If it is within the discretion of the Board, some
allowance might be made for new licensees, particularly those
converting from limited license status, to meet these requirements
within a defined period of being issued a license. Failure to allow
a grace period may impede efforts to recruit and place needed
physicians. We would also urge the Board to develop a deemed status
for those showing meaningful use or other demonstration of
competence with EHR's. Clearly basic CME programs for many
physicians who are immersed in systems and have been for some time
serve no legitimate purpose.
Participation in a Risk Management Program
This is one of the areas where the legislature amended the
disciplinary section rather than the requirements for licensure.
1 The full text of the provisions of section 5,
which date from 1986, are included in the footnote below. To say
that the statutory language is unclear is an understatement. Not
all physicians are hospital based and have the opportunity to
participate in a patient care assessment program. It is unclear
what other programs qualify and regulations in Section 3 covering
this have not yet been drafted. While we appreciate the Board's
efforts to comply with this statutory requirement from 25 years
ago, it provides no guidance as to what is required as a condition
of licensure. The MMS suggests this section be clarified or struck
until section 3 is drafted.
Post Graduate Medical Training
The MMS supports the increased training requirements as
reflective of current standards. The addition of one year of
training for domestic and foreign graduates is consistent with
current standards. However, it is not consistent with the current
law which makes specific reference to one year of training for
foreign graduates in Chapter 112 Section 2. The Board should make
efforts to correct this rather than exercising its discretionary
regulatory authority in a manner inconsistent with the plain
language of the statute.
Seven Year Rule
The MMS recognizes the Board's statutory authority to give
examinations and set the standards for passing such rules. The new
standard is more restrictive in the number of times an applicant
may take Step 3. The exclusion of applicants unable to pass in four
attempts and the addition of one year of graduate study for those
who fail three times as a precondition for the fourth attempt is
within the Board's discretion. The provision of waivers for the
Board on the seven year rule allows for circumstances not
reflective of an applicant's ability.
Emergency Licenses
The MMS supports the provision for displaced physicians to
be licensed in MA but we also have concerns about supporting
physicians without full MA licenses in their efforts in a local
emergency. MMS recognizes that protecting patients and the
community's health during emergencies may require the contributions
of a number of different types of volunteer health professionals to
create sufficient surge capacity to meet the needs of the
Commonwealth. In order to help ensure that volunteer health
professionals are able to safely join the response, MMS has
contracted with the Massachusetts Department of Public Health (DPH)
to assist with the development and support of MA Responds. MA
Responds is a management system implemented and coordinated
administratively by DPH that recruits, registers and verifies the
credentials of medical volunteers before a disaster strikes to
allow volunteer medical professionals, if called, to supplement the
existing hospitals and other response agencies in a major disaster
event. The MMS Committee on Preparedness has served a vital
role in guiding contract staff in its effort to meet the
deliverables of its DPH contracts.
In the aftermath of the 2008 ice storm, and again in the H1N1
pandemic, physicians from the MMS Resident and Fellow Section
communicated to the MMS Committee on Preparedness that they
believed that many physicians -in -training (residents) would like
to be able to be a part of the emergency response system in
Massachusetts, and provide urgent and emergency care within the
scope of their training during a large-scale public health
emergency or disaster. Resident and fellow volunteers have medical
licenses and have sufficient medical education and training that
will enable them to provide a range of medical services, including
first aid, vaccination, screening of patients, educating the public
on the medical consequences of the disaster or performing other
basic clinical duties.
Currently, if resident physicians provide such services,
regardless of the necessity for such services, they are exposing
themselves to the risk of civil and criminal liability for
practicing outside the scope of their limited license without
supervision by their residency or fellowship program. In
order to recruit and register physicians-in-training to be part of
the state's volunteer response capacity, we need to ensure that
they can participate at an appropriate level of support, without
putting their limited licenses at risk for practicing outside their
legal scope.
As with all other physician volunteer responders, MMS recognizes
that those who want to assist need to be identified, registered and
pre-credentialed before an event occurs.
MMS respectfully requests that the Board consider amending the
current regulations to allow physicians-in-training registered with
MA Responds to volunteer in an appropriate capacity, independently
without direct supervision by a fully licensed physician, when
requested by DPH for state and local response.
Revising the proposed regulations in this manner would allow the
Commonwealth of Massachusetts to utilize a significant resource in
providing emergency medical care to the public
Restricted Licenses
The MMS recognizes that the Board has authority to
restrict licensees in their practice. However, there should be some
grounds for triggering reviews of practice and establishment of
practice restrictions. This is a critical element of due process to
preserve the inherent rights of license holders and to ensure that
actions are not arbitrary and capricious. The current right to
restrict licenses in the proposed regulations has no limit.
Prerequisites for Limited Licenses
The MMS supports the Board in its reasonable approach to
exempt limited licensees from training requirements specified for
full licensees. We urge the Board to consider a grace period for MA
limited license holders seeking to convert to full licensees.
Duration of Limited Licenses
The MMS strongly supports the extension of limited
licenses to the duration of the program.
Revocation of Limited Licenses
The Board asserts its statutory authority to revoke a
limited license. Past practice of the Board has restricted its
disciplinary actions for limited licensees to revocation. The Board
should use the regulations to give itself greater flexibility in
choosing sanctions for discipline, to include reprimands, probation
and other options short of revocation.
Volunteer License
The MMS strongly supports volunteer physicians in their
service to their communities. We have long supported a volunteer
license category. However, the specific language that the Board may
require a clinical skills assessment from an applicant is
prejudicial towards these physicians. As in other categories of
license, the Board must establish grounds before setting such
preconditions on obtaining a license. The only potential advantage
to a volunteer as opposed to a full license is a possibility of a
reduced licensing fee. Clinical skills assessment programs are
considerably more expensive than full licensing fees. Volunteer
licenses should be an honored and respected category not burdened
with an expectation of incompetence among all applicants.
Administrative License
As noted above, the MMS strongly supports the concept that
license categories are voluntary. We therefore support a reading of
the change of license status provisions to cover only changes
initiated by the licensee. The provisions of changing from
administrative back to full license status are so daunting that
this category appears to be one that few physicians will find
attractive. Additionally the limitations on the role of an
administrative licensee raise questions about whether such
limitations have an impact on specialty certification renewals or
on licenses in other states which may consider a transfer of status
a reportable event.
Licensing Requirements
The Board specifies that applicants must update any change
in licensing application information "as soon as he or she becomes
aware of the change in information, but in no event later than 72
hours." This wording implies that an applicant must notify the
Board of a change in registration information, even when the
applicant is unaware of the change. Certain information is critical
to the application process, but other information is not. The Board
should reword this section to reflect the importance of different
information. A change of temporary residence by a graduating
student is of less importance than a felony conviction for
example.
Exception for specific health information
The MMS supports specific reference to exceptions for
participants in qualified programs.
Denials of Licensure
The MMS believes that the Board should offer greater
grounds and specificity for why it denies a license. This is
particularly true in cases of denials of renewal where
constitutional interests are well established. The MMS strongly
objects to the wording of the determination of a right to a
hearing. The Board reserves the right to deny an applicant and to
do so without a hearing unless it finds that grounds exist for it
to overturn its own ruling. Elsewhere in this testimony the MMS has
commented on concerns relative to the composition of committees of
the Board and majority votes of the Board. While the regulatory
language implies otherwise, denials of licensure will be voted on
by the full Board as part of licensing recommendations with no in
depth consideration of applications or any personal appearances
before the full Board.
Renewal During Suspension
The Board is putting into regulations one of its practices
for the last several years. That practice is the denial of renewals
for all licensees under suspension. Licensees who do not complete
the license process are revoked by law. Thus a physician suspended
from practice for 90 days whose renewal falls within that period
will be revoked. The practice on reinstatement of revoked licenses
has been difficult, expensive and time consuming for many
individuals. If the Board is seeking revocation rather than
suspension it should revoke the license in the first place.
Suspended licensees should have the right to renew their licenses
while under suspension.
Electronic Health Records
The MMS strongly suggests that the Board determine methods
other than CME's for establishing competence in electronic records.
The legislative intent was clearly to ensure that physicians not
using EMR's are aware of their use and implications for their
patients. They clearly wanted to move physicians towards meaningful
use. There was no intention to subject active users of electronic
records to basic CME courses.
Return from Inactive Status
The proposed regulations allow a physician with an
inactive license status to request a return to active status. Such
physicians must satisfy requirements for education and liability
coverage. However, meeting these requirements seems to be necessary
to request a return to active status, but nothing is said regarding
the Board's process for responding to such a request.
Return from Retired Status
The MMS strongly supports a presumptive right of return to
active status for retired physicians who have no pending
complaints. This right of return should apply to all
administrative, inactive license and volunteer license categories.
We do question the evidence base for determining that two years out
of active practice is the limit for all types of physician
practice. We also question exactly how "current clinical
competency" will be demonstrated. The Board may be limiting the
public from access to services of competent physicians who have no
programs available to prove competence by its use of the word shall
in this provision. Clearly there may be cases where return to
practice raises no issues in spite of a physician's having been
inactive or retired for two years. However, this draft language
would give the Board no discretion and demand a clinical competence
demonstration.
Request for Extension
The MMS supports the Board in its efforts to provide
relief from the onerous interpretation of existing law regarding
lapsed licenses. The law provides that incomplete applications
result in revocations but they also require reinstatement of
license status once applications are completed. The Board should
expand these provisions to allow broad leeway in renewing licenses
for individuals with no clinical or legal issues but simply
technical problems or minor clerical issues.
Continuing Professional Development
We also recognize and support that Continuing Medical
Education (CME) as we once knew it is morphing into what has now
become continuing performance improvement, self-assessment, team
learning, leadership development and high-quality, evidence-based
clinical practice that supports transparent, cost-effective and
accessible patient care. With rapidly changing technologies
and ongoing clinical research, physicians are challenged every day
by new developments in diagnosis, treatment and ongoing management
of their patients, not just their disease or illness.
The Federation of State Medical Boards along with the American
Board of Medical Specialties, the American Medical Association, the
American Hospital Association and many, many related health
organizations have come together to discuss strategies to improve
health outcomes and identify gaps in practice that contribute to an
unsustainable US health care system. The answer to this
conundrum will not be realized through mandated CME. A
definitive answer may never be realized due to the diversities
within the health care environment. However, by working
together, by working in unison, toward a common goal of patient
safety and high-quality, cost-effective patient care, we will
provide the necessary educational activities appropriate learning
activities catalyst for improved health care practice and outcomes
in the Commonwealth.
On behalf of the MMS, as an advocate for physicians throughout
Massachusetts, we seek an amendment to the Board's mandated CME and
instead support its facilitation of continuing ongoing professional
development performance improvement through certified (or
deemed) continuing medical education that is based on identified
evidence-based measures; ongoing assessment; intervention and
continuous performance improvement. This system-wide
approach will yield greater results than mandating single-targeted
areas. through a system-wide approach.
The MMS recognizes that the Board is working towards new methods
for assisting physicians to stay current in their skills. CME
credits now are awarded based on a long established national
system. The Board should include deemed status for all current and
future CME credit programs which meet national standards to be
recognized as continuing professional development credits as well.
The Board should also set strong regulatory standards regarding how
it will recognize CPD programs which do not have CME accreditation.
A formal process for review, with participation from existing CME
providers is essential for establishment of this bold new process
to succeed.
In addition the Board should review its drafting on the proposed
regulations. One regulatory citation is incorrect regarding
mandated CPD credits, the Post Graduate Medical Institute no longer
exists, and the AMA does not approve CPD's. Renewing licensees will
be confused when trying to determine whether they have met
requirements which reference imprecise standards.
We have consulted with Dr. Murray Kopelow, CEO of the
Accreditation Council for Continuing Medical Education about the
proposed language He has recommended the following as it
accurately defines the roles of accrediting bodies, where the
current proposed language of the BORM is misleading.
Category 1. Not less than 40 CPD credits
(example: AMA PRA Category 1 CreditTM; AAFP Prescribed credit
or AOA Category 1-A) from an organization accredited by the
Accreditation Council for Continuing Medical Education (ACCME), the
American Osteopathic Association (AOA), the American Academy of
Family Physicians (AAFP) or a state medical society recognized by
the ACCME. The entire 100-credit requirement may be completed
by earning Category 1, Prescribed or 1-A credits.
End-of-Life Care studies:
Every renewing licensee must have at least 2 credit hours in
End-of-life Care education or training, in either Category 1 or
Category 2. The Board states that it has developed this CPD
requirement in response to the work of the Commission on End of
Life Care and the EOHHS Expert Panel on End-of-Life Care,
established in St. 2008, c. 305, §§ 41-43. While the MMS supports
the importance of this issue and has worked for years to make
proxies available and increase awareness on end of life issues,
there is no legislative mandate or authorization for this
requirement. Therefore we oppose the mandatory inclusion of this
condition for licensure based solely on the Board's perception of
this as an issue of significance. Should the Board take this road,
it will be besieged by interest groups seeking special status for
their particular issue or disease, just as the legislature is
today.
Clinical Assessment:
The Board may require a licensee to participate in clinical skills
or competency assessment, if any such programs exist or require
applicants for renewal or revival to appear for a personal
interview. The Board should establish some criteria for triggering
this level of scrutiny, particularly for those renewing a license
who have no complaints or issues. Is this scrutiny to be age based,
specialty based, training based or based on some criteria which may
raise issues of discrimination or personal bias among the Board
staff and members. The MMS appreciates the Board's responsibility
in not licensing or relicensing incompetent physicians, but we
respectfully suggest that some specific criteria be included in
these broad powers.
Calculating Credits
The language of this section is unclear and will be
difficult for physicians to follow. This section should be
clarified to alert newly licensed physicians as to their
requirements for an initial license. We urge the Board to give the
greatest discretion possible to applicants for a new full license
in Massachusetts to meet the unique Massachusetts CME requirements
upon renewal of their initial license or at some point after
licensing in Massachusetts. This provision will allow recruitment
in shortage areas without delays to meet Massachusetts's unique
requirements.
Reinstating a Lapsed License
The MMS urges the Board to rewrite this section to deal
with physicians with technical lapses rather than suspensions with
a denied renewal leading to lapses as commented on previously. This
language is problematic in the cases of disciplined physicians not
allowed to renew: "If the Board has reason to believe the lapsed
licensee has committed a violation of law or regulation, or has
deviated from good and acceptable standards of medical practice,
the matter will be forwarded to the Enforcement Division."
Clearly already disciplined physicians fall into the category above
but should not be subject to a further review and delay by the
enforcement division when their suspension period is over. Any
physician practicing during suspension or a lapse can be the
subject of a separate complaint.
The Practice of Medicine
Certain Reporting Requirements for Physicians
The MMS is aware that the Board is responding to
legislative mandates in establishing a reporting requirement of
ownership interests in for profit acute care hospitals or HMO's.
This is particularly difficult when ownership interest includes
stock holdings, "membership" and profit sharing agreements. The MMS
supports the exemption to this rule for participating providers in
HMO's and PPO's. The Board is urged to not to aggressively engage
in disciplinary action if a physician inadvertently fails to report
a stock transaction, perhaps even a mutual fund investment, in an
entity which has ownership interests in health care hospitals or
HMO's.
Delegation of Medical Services
We support regulatory requirements that delegated services
be consistent with standards of care. We are concerned about new
language making physicians absolutely responsible for the acts of
those to whom services are delegated. This language would apply to
a wide range of professionals, including for example nurse
practitioners who deviate from their practice guidelines in spite
of every effort on the part of the supervising physician to
maintain standards. We are concerned that this one sentence could
create absolute liability for physicians in cases in which they
have fully met the standards of care and are not responsible for
the result a patient experiences. Clearly the Board may discipline
physicians for delegation of medical services which don't meet the
standard of care. Language creating absolute liability is not
helpful to the Board in its responsibilities.
Advertizing and Professional Notices by a Full
Licensee
The proposed regulations add a provision that physicians
may professionally use social media and participate in social
networking, provided that they maintain patient privacy,
confidentiality, and "appropriate ethical standards". Licensees
must maintain a "complete, accurate and reproducible version of the
information the licensee disseminated to the public for three years
from the date of posting." It is important that limitations on the
use of social networking apply to licensees in their professional
activities only and not in their personal lives. The Board should
clarify that it has no interest in the social uses of media by its
licensees. This would not preclude the use of such activities in
investigations of behavior that involves disciplinary offenses.
However, the Board has no interest in requiring record keeping by
licensees of their social interactions, nor does it have any
interest or authority in limiting social networking to professional
activities.
Requirement to Respond to the Board
This section maintains existing requirements to respond to
a communication from the board or its designees within 30 days with
"any relevant and authorized records". This reiteration of current
regulations takes no consideration of new laws and court decisions
on the rights of patients to privacy in their records. Response to
subpoenas from the Board's enforcement division are an ongoing
legal issue for physicians and patients. The Board should reflect
recent decisions in the Hallmark case, federal law and
regulations. Additionally reports from defense attorneys
indicate that physicians have been subject to disciplinary actions
for asserting legitimate patient privacy rights in refusing to
provide patient records without consent. There are clear limits to
access to psychiatric records and peer review materials at a
minimum. The Board should amend the regulations to require a
response to the Board within specified time frames, but allow for
good faith refusal to provide patient records without a court order
where a specific and valid legal objection is raised.
The proposed regulations add new language which requires a
response to the Board and its committees within ten days. It is
unclear when 30 days apply and when 10 days apply. It appears that
Board Committees which often contain only one board member who may
or may not participate in authorizing orders to licensees, are
granted specific 10 day authority while the Board itself and its
designees get 30 day authority.
The ten day provision should be for an action approved by the vote
of the Board and should apply only to lawful orders which don't
raise issues such as patient privacy.
Providing Patients with Treatment Information
This section takes existing regulations mandating
provision of treatment information to breast cancer patients and
essentially edits it to remove references to the specific disease
and to apply this to all treatment information. Different medically
viable treatments must be described , questions must be answered
regarding treatment options. An opt out provision is included if
the patient declines to hear alternatives. The original
regulations reflect specific inclusion of breast cancer in the
general laws on patients rights in hospitals. The Board is
expanding this requirement with no basis in law. While standards of
care dictate full disclosure of options for patients, it is
unnecessary to create a regulatory right to such information in all
treatments at all times. The Commonwealth has seen an increase in
loss of chance professional liability suits. Creation of a
regulatory right to information on all viable treatment options in
all cases increases the presumption that the lack of such
information caused patient harm. Exposing physicians to
disciplinary action for failure to provide information which was
not relevant at the time but which subsequently is proven to be
relevant is a harsh and unnecessary regulatory standard. Patients
may sue for failure to provide informed consent and they may
complain to the Board as well for such failure to meet standards of
care. However, a strict regulation in this area is overreaching and
unsupported by legislative mandate.
Mandatory Medical Malpractice Coverage
The proposed regulations delete the following language in
the current regulations: "In lieu of obtaining such
professional malpractice liability insurance, the licensee may
petition the Board for permission to obtain a suitable bond or
other indemnity against liability for professional malpractice, in
the amounts specified above."
This language is in the general laws Chapter 112 Section 2 and
is not within the Board's discretionary authority to delete. It may
be little utilized but it is legislatively mandated.
Business Organizations and the Practice of Medicine
The MMS supports the corporate practice of medicine doctrine in
that physicians must have control of all decisions relating to
their practice of medicine. It is not clear in the Board's proposal
that the Board is not requiring a physician to control business
decisions of entities over which he or she has no control. For
example, does the Board require that a participating physician have
control over formulary decisions of a health plan? What does the
regulation require of physicians? This needs clarification.
The Board's existing regulations prohibit limiting of liability
through incorporation. However, those regulations were promulgated
prior to the existence of limited liability corporations in
Massachusetts. The Board's proposed language is unclear,
particularly by including professional corporations in the
prohibited section (b) list. What is the impact of the proposed
language on existing corporate structures in Massachusetts? Has the
Board done a business impact study to determine whether the
proposed changes will require new corporate structures for
Massachusetts physician practices?
Exception for Reports to the Board under M.G.L. c. 112, §
5F: The phrase "chemical dependence" is replaced with
"unauthorized substance use." However, this phrase only applies to
exemptions from reporting for individuals in approved treatment
programs. Therefore, the change is appropriate. The Board appears
to have removed requirements that no patient harm has taken place
as one of the grounds for exemption from reporting and placed them
under an incorrect heading regarding guidelines.
Supervision of Physician Assistants
The MMS has no concern with the Board's expansion to four
supervisees as it is mandated by statute. We support the role of
the Board in active oversight of the relationship between
physicians and those they supervise. We strongly support the Board
in its specific regulations governing the roles and duties of
supervising physicians for Physician Assistants and Nurse
Practitioners.
Fluoroscopy
The MMS supports the use of a prescribing guidelines model
in the supervision of fluoroscopy.
Supervision of Advance Practice Registered Nurses
The MMS supports the Board in its reiteration of existing
regulatory requirements on supervising physicians. However, we note
that the requirements are deleted or lessened in the following
existing provisions which specify elements of guidelines
including:
4. identify the types of medication(s) to be prescribed,
specify any limitations on medications to be prescribed, and
describe the circumstances in which physician consultation or
referral is required;
5. describe the use of established procedures for the treatment of
common medical conditions which the nurse may encounter;
6. include provisions for managing emergencies;
7. include a defined mechanism to monitor prescribing practices,
including documentation of review by the supervising physician at
least every three months;
8. include protocols for the initiation of intravenous therapies
and Schedule II drugs
The MMS is not sure what evidence exists to reduce these
requirements and supports their retention.
Collaborative Drug Therapy Management
The MMS supported the legislation establishing
collaborative drug therapy management and we are supportive of the
Board's draft regulations as they are consistent with the
statute.
The Data Repository
The MMS supports the Board in its assertions that mandated
reports are presumed confidential. However, there are ongoing
issues with access to mandated reports by physicians named in the
reports. The MMS strongly believes that physicians should have
access to complaints as is clearly required in MGL Chapter 112
Section 5 "nor shall the requirement that investigative records of
information be kept confidential at any time apply to requests from
persons under investigation". The statute states that regulation
should enforce this right to the complaint. Common sense and
efficiency requires that physicians called in to answer a complaint
should have access to the complaint to ensure that an accurate,
complete and honest answer to the complaint may be presented.
Physician Profiles
The MMS created the physician profiles program through
legislation several years ago under the leadership of Michael Kelly
Esq. its Director of Government Relations. The MMS is concerned
about the sentences: "The DRC and its staff may review certain
legal aspects of the Physician Profile Program and its online
website. Mandated reports shall be reviewed according to policies
and procedures set by the DRC or the Board." At Board meetings in
the past, Board staff have asserted the discretion to include
information on profiles not included in the enabling statute for
the program. The phrase was used that the statutory list of profile
elements was a floor not a ceiling. The MMS objects in the
strongest possible terms to the vague language offered in this
regulation that may attempt to allow Board staff to defy the law on
profiles. Clearly the Board should not be delegating broad and
vague authority to its staff on matters governed by statute with
specificity. The language in section 2.15 appears to reflect the
statute on the contents of profiles and we suggest the phrases
above should be deleted in deference to this section.
Regarding the right of physicians to review profiles, this is
statutory and the profile must be provided to the physician prior
to its publication. The Board's statement that the subject of the
profile may see it on the website along with the general public
does not meet the statutory requirements of prior review. The
intent of the MMS in drafting this statutory wording was clearly to
prevent errors from ever being published. The Board should provide
profiles by email to a subject ten days prior to publication in
order to give time to review and correct errors.
Similarly the Board should provide guidance on profiles disputes
regarding the rights of subjects. The language in section 2.15
provides no procedural guarantees to physicians about the
correction of even egregious errors. Stating what the DRC may do
regarding a dispute does not state what it will do. Clearly the MMS
has no interest in setting up procedural roadblocks to the
production of accurate profiles, even those which contain accurate
but damaging reports on liability cases, criminal convictions or
hospital discipline. The Board should specify rights of
appeal that give physicians the statutorily guaranteed rights to "a
reasonable time to correct factual inaccuracies that appear in such
a profile." 2
Similarly the MMS is concerned about an ongoing issue about
statutory reports from nursing homes being included on profiles.
While these are mandated reports, they are not included in the
statutory basis for profiles and it is not within the authority of
the DRC or even the full board to declare otherwise. The support
summary from the Board staff lists reports from health care
facilities as an element of profiles. This is not correct. Hospital
disciplinary systems have far better due process than nursing
homes, pharmacies or clinics. This is the reason that hospital
reports are deemed correct and placed on profiles while reports
from other facilities are not. The statute is clear on only
hospital reports related to "competence or character in that
hospital" are to be included.
Mandated Reports
The proposed regulations require reports of all
restrictions on privileges in a hospital or facility. The
existing regulations require: "A denial/restriction of
privileges or resignation shall be reported only when the
resignation or denial/restriction of privileges is related in any
way to:
1. the applicant's competence to practice medicine, or
2. a complaint or allegation regarding any violation of law or
regulation (including but not limited to the regulations of this
Board), or hospital, health care facility or professional medical
association by-laws, whether or not the complaint or allegation
specifically cites violation of a specific law, regulation, or
by-law. Hospital Privileges. A licensee shall notify the
Board of any restriction or termination of his hospital
privileges, other than restriction or termination for minor
administrative reasons, within 30 days of its occurrence."
The Board has expanded its definition of a facility to include
anywhere medicine is practiced so now physicians are mandated to
report any resignation from a group practice. Further the Board
eliminates actions not related to competence or character.
Failure to file a mandated report is a disciplinary offense. The
Board should seriously reconsider whether it wants reports every
time a physician changes jobs or group affiliations. Does the Board
want to discipline a licensee for failing to notify it of
termination of hospital privileges after leaving a position?
Language in the regulations also considers information requested
by licensing to be a mandated report. Falsification of licensing
materials is a serious offense. What is the purpose in making such
materials a mandated report?
The MMS supports the reporting of events in office settings
"precipitated by a treatment administered or a procedure performed"
in the office. This is similar to hospital reports to the
Department of Public Health.
Conclusion
The MMS appreciates the work of the Board in proposing these
regulations and in its careful considerations of the thoughtful
comments of those who devote considerable time and resources to
review of those regulations in an effort to create fair and
balanced regulations which will provide guidance to Board members
and staffs for years to come.
1 There shall also be established within the board of
registration in medicine a risk management unit. Said risk
management unit shall provide technical assistance and quality
assurance programs designed to reduce or stabilize the frequency,
amount and costs of claims against physicians and hospitals
licensed or registered in the commonwealth. The board shall
promulgate regulations requiring physicians to participate in risk
management programs as a condition of licensure; provided that such
regulations shall provide for an exemption from such requirements
for physicians who are participating in pre-existing risk
management programs that have been approved by the board.
2 MGL Chapter 112 Section 5
