The Massachusetts Medical Society appreciates the opportunity
to provide comment on proposed changes to the “Standards for Prescription
Format and Security in Massachusetts” (105 CMR 721.000) regulations of the
Department of Public Health. The Medical
Society has continuing concerns regarding the implementation and scope of these
proposed regulations, which execute provisions of chapter 208 of the Acts of
2018—the CARE Act. Accordingly, the Medical Society urges further consideration
and adjustment to ensure that physicians throughout the Commonwealth can continue
providing quality health care to their patients without jeopardizing patients’
access to care.
While the electronic prescribing provision of the CARE Act aspires
to bring the promise of greater prescription security, the Medical Society remains
troubled by the breadth and inflexibility of this mandate, which requires
electronic prescribing of every prescription generated within the
Commonwealth of Massachusetts. Although
the Medical Society applauds the intention to improve security for, and convenience
in, the prescribing of controlled substances, we remain concerned that the
proposed regulations fail to achieve a practicable balance between those aims
and the burdens imposed by clinical implementation of this requirement.
Many other states have recognized the benefits of electronic
prescribing and passed legislation mandating its use, but Massachusetts is the
only one to extend this requirement to non-controlled substances, requiring
that all prescriptions be issued through a federally compliant
electronic prescribing system. Removing
the option of a paper prescription for innocuous and commonly prescribed
drugs—even Schedule VI drugs, such as blood pressure and cholesterol
medications, which are not even subject to the Massachusetts Prescription Monitoring
Program—establishes regulatory requirements with little flexibility to account
for the unpredictability of daily medical practice. Accordingly, the success of this law depends
on constructing regulations that provide flexibility for physicians to treat
patients in diverse and distinctive situations given the variability posed in
their practices. Broader and more
accommodating language in these regulations will ensure uninterrupted access to
care for patients throughout the Commonwealth, while at the same time
progressing the security and seamlessness of prescriptions generated therein.
The inflexibility of these implementing regulations will
cause inefficiencies in care, which inconvenience patients and potentially put them
at risk of delayed treatment. The
technical limitations and uncompromising nature of the electronic prescribing
system has led New York state to revisit their electronic prescribing mandate
to provide both legislative and regulatory flexibility through post-hoc mechanisms
such as blanket waivers and guidance letters.
In addition to procedural burdens, the implementation of federally
compliant electronic prescribing systems will necessitate large, and at times cost-prohibitive,
expenditures to provide continuous medical care. Electronic prescribing systems require both
upfront investment and annual fees on a per prescriber basis. These expenses, though necessary for
compliance with these regulations, may cause significant disruption in
physicians’ practices, ultimately to the detriment of patients.
For those reasons, and the reasons stated more fully below,
the Medical Society urges further consideration of these regulations
implementing the requirement for electronic prescribing.
105 CMR 721.075 Time Limited Waivers of ePrescribing
Requirements
The Medical Society strongly supports the provision of waivers
for electronic prescribing requirements as provided by 105 CMR 721.075;
however, in order to ensure necessary continued access to care for patients
throughout Massachusetts, it is imperative that the circumstances worthy of
such waivers are broadened to include situations not currently contemplated
within the proposed regulations. While
electronic prescribing may provide modestly improved security in the prescribing
of certain high-risk drugs, the reality is that the mode of prescribing has no
effect on the quality of medical care provided. Jeopardizing patients’ access to high-quality
medical care through a technological mandate, which may at times be wholly
unrelated to the prescriptions of certain physicians, would be tremendously
concerning. A flexible and comprehensive
waiver provision is the only means to avoid disparities and disruptions in access
to care in these most difficult scenarios.
As currently constructed in 105 CMR 721.075(A)(1), waivers are
available only in instances of economic hardship or technical limitation. Accordingly, the Medical Society believes
that 105 CMR 721.075 requires amendment to accommodate unforeseen situations
that may make compliance with the electronic prescribing requirements
impracticable, infeasible, or impossible.
Each waiver application is ultimately reviewed and decided upon by the
Commissioner; thus, establishing broader and more inclusive waiver requirements
will provide much needed latitude for practitioners, who face unique and
challenging hurdles to implementation, without significant detriment to
achieving the underlying safety goals of these regulations. We believe these
amendments can be offered in manners consistent with the underlying statutory
language.
Furthermore, the nature of some physicians’ practices and
patient populations requires greater leniency regarding electronic prescribing requirements,
as the demands of these practices may be incompatible with the requirement. For example, physicians nearing the end of
their career may require a waiver to provide for their existing patients until
continued care can be arranged. To
require such a change to federally compliant electronic prescribing systems in
their day-to-day prescribing practices may jeopardize the viability of their
practice without specifically calling into question financial hardship or technical
limitation. Nonetheless, the winding
down of their practices may take multiple years, so a renewable waiver process
should be available for those who have extenuating circumstances that demand the
Commissioner’s revisiting of the nature of the physicians’ need for exemption
from the electronic prescribing requirement.
Some prescriptions, such as radiology contrast media are
often prescribed in settings that are incompatible with electronic prescribing
systems as mandated by these regulations.
In these situations, the provision of compliant systems is not yet
established. Practitioners in those settings
would need the radiology information technology marketplace to evolve in order
to comply with the regulations as proposed.
This sort of situation is the type where the Medical Society would hope
a time limited waiver could be provided.
However, if the marketplace does not develop quickly enough, a renewable
waiver may be appropriate.
If flexible revision is not offered, many physician
practices—and the patients they serve—may face difficulty achieving seamless
prescription procedures. Small practices,
and those who have typically relied upon paper medical records, would
specifically be disadvantaged by their economies of scale. Such small practices would experience a
disproportionate financial burden in their attempts to develop and implement an
optimal, integrated electronic prescribing system. The population of patients, whose choice in
medical care may already be limited, would also be encumbered by this increased
cost of care or by their physicians’ inability to prescribe any medication without
a waiver. Without much needed
flexibility, each patient—and all of their relevant health information—would
have to be digitized to get even a mild Schedule VI medication.
Thus, to ensure minimization of disparate impact implicated
by the electronic prescribing requirement, the language pertaining to waivers
must be constructed more broadly, with greater flexibility, to guarantee
continued access to care for all patients in Massachusetts.
105 CMR 721.070 ePrescribing Exceptions
DPH exceptions to the electronic prescribing requirement are
provided through Chapter 208 of the Acts of 2018. These exceptions, provided in 105 CMR 721.070,
should contemplate the types of challenges practitioners might face with
electronic prescribing in their daily practice; however, the Medical Society
believes that the stated exceptions are not sufficiently comprehensive to
ensure continuous access to care for all patients in the Commonwealth. For this reason, the Medical Society advocates
for broader language of exceptions alongside a continued appreciation for the
evolving prescription landscape that may come to include prescription
medications and devices that are not currently anticipated by these
regulations.
Specifically, the Medical Society suggests a broad exception
as follows: any prescription issued or dispensed under circumstances where electronic
prescribing is unavailable or impracticable due to unforeseen circumstances
outside a practitioner’s or health care facility’s control. Such situations should never put patients who
need medication in danger of being unable to have their prescriptions dispensed
to them in a timely manner.
One example where proper health care delivery is
incompatible with electronic prescribing is when a patient presents to an Emergency
Department late at night and is unfamiliar with the area or the pharmacies
nearby. Under these regulations, in
order to get the medication prescribed, the patient would have to pick out a
specific pharmacy for the prescription to be sent. Current electronic prescribing systems do not
always allow pharmacies to transfer prescriptions to other pharmacies. If the
pharmacy that the patient initially chose happens to be closed at the time, or
out of stock of the medication, the patient’s physician would have to be
notified of the error and will have to send the prescription all over again to
another pharmacy, where the patient may finally be able to access the
medication originally prescribed. Here
the electronic prescribing mandate burdens both the patient and the physician. This situation could be avoided if the
regulations granted greater leeway for prescribing in otherwise valid, secure
manners.
The strictures of current electronic prescribing systems
make electronic prescribing unwieldy at times.
If a prescription comes with a lengthy or complex set of instructions,
prescribers are limited to providing only the instructions that fit within the
text field provided by the electronic prescribing system. This limitation undermines doctors’ ability to
provide the highest quality of medical care and could negatively affect patients
who may struggle to understand the forcedly abbreviated instructions. For example, prescriptions for infusions have
a wide range of dosing and concentrations, coupled with frequent changes in
dosing, which make electronic prescribing cumbersome and inefficient. Infusion drugs are just one type of
prescription that should be granted exception from the electronic prescribing
requirement. This exception would be
very similar to the exception for compounded drugs found at 105 CMR 721.070(A)(8).
New York has created an exception for such infusions by
excluding from the requirement for electronic prescribing “controlled or
non-controlled substance[s] to be compounded for the direct administration to a
patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal
infusion.” The Medical Society supports
this language and strongly urges DPH to consider adding language to similar
effect in these regulations.
Another situation necessitating more flexible language of
exception includes prescriptions for international patients, who, without a
United States address, cannot be prescribed medication in electronic
prescribing systems that lack the capability of receiving international home addresses.
Additionally, similar to the exception for expedited partner
therapy, provided by 105 CMR 721.070(A)(7), prescriptions for close contact
prophylaxis would need either an explicit exception or broader, more inclusive
language so that local outbreaks of communicable diseases, such as pertussis or
meningitis, may be quelled at the outset before they become widespread
emergency situations.
The Medical Society appreciates the exceptions provided, such
as the durable medical equipment exception, but urges similar continued
attention be paid to the evolving need for medical orders that fall under the
purview of these regulations, but which necessitate exception to ensure quality
health care can be provided in a safe, secure, and seamless manner. As health care is an ever-evolving field, these
regulations must provide flexibility for prescriptions that do not fit neatly
into the electronic prescribing requirement as presently proposed. These regulations must provide flexibility for
prescriptions that do not fit neatly into the mandated electronic prescribing
systems as presently required; therefore, it is imperative that the exceptions
provided in 105 CMR 721.070 grant leeway to prescribers for situations where
electronic prescribing could cause administrative burden, prescription delay,
or patient harm.
105
CMR 721.065 Special Procedures for Emergency Prescribing
The
Medical Society applauds the Department’s definition of ‘emergency situations’ in
105 CMR 721.060, as it provides dynamic flexibility for physicians to provide quality
medical care under these circumstances that demand independence to determine
the best course of action.
The Medical Society also generally supports the emergency
prescribing exception for Schedule II Controlled Substances; however, the follow-up
requirement in 105 CMR 721.065(A)(4) that obliges practitioners to follow an
oral prescription with an electronic prescription within two business days is
inconsistent with reasonable medical practice.
As understood by the follow-up requirement in105 CMR 721.070(B), a
follow up time period of seven days is a reasonable expectation, as it lessens
administrative stresses but still verifies oral orders. A seven-day deadline is more appropriate than
a two-day deadline especially when considering pharmacists’ obligation to notify
the DPH Commissioner of a physician’s failure to comply with this strict
requirement. The Medical Society also opposes
mandating that pharmacists notify the DEA or USDOJ, as Massachusetts’ DPH
serves as a more appropriate gatekeeper of such reports and can elevate them to
federal authorities if so needed. The
above notwithstanding, the Medical Society flatly opposes these regulations mandating
pharmacists to notify government officials of a delay in prescription follow up.
Pharmacists’ Obligations
Because a seamless prescribing system is imperative to
providing quality medical care, any instance of resistance in the process of
filling a prescription would negatively impact patients in Massachusetts. If pharmacists are required to verify whether
prescriptions they receive fall under exceptions or waivers, administrative
delay and complication will result. For
those reasons, the Medical Society supports additional language as proposed by
the Massachusetts Chain Drug Store Council as follows:
“A pharmacist who receives a written, oral or faxed
prescription is not required to verify that the prescription falls under one of
the exceptions from the requirement to electronically prescribe. Pharmacists may continue to dispense
medications from otherwise valid written, oral or fax prescriptions that are
consistent with current laws and regulations.”
The Medical Society believes this language—or language to
similar effect—is vital to ensuring the delivery of quality medical care. This language allows pharmacists to focus on
the substance of the medications that have been prescribed and less on the administrative
procedure by which they were sent the prescription. It also allows patients to receive
medications that are prescribed to them as intended. Lastly, it allows practitioners to utilize
the exceptions in an efficient and safe manner.
The Medical Society appreciates this opportunity to be heard
regarding concerns about the proposed regulations of 105 CMR 721.000 and urges
continued consideration of the regulations with regard to these comments and those
of many other interested stakeholders.
