Massachusetts Medical Society: Comments Regarding Proposed Regulatory Changes to “Standards for Prescription Format and Security in Massachusetts” (105 Cmr 721.000) Regulations

Comments Regarding Proposed Regulatory Changes to “Standards for Prescription Format and Security in Massachusetts” (105 Cmr 721.000) Regulations

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.

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