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October 15, 2020

Upcoming Medicare Requirement Around Electronic Prescribing of Controlled Substances

The SUPPORT Act—the major law passed in 2018 that addressed the opioid crisis—requires there to be electronic prescribing for controlled substances (EPCS) in the Medicare Part D Prescription Drug Program beginning in 2021. As discussed in last week’s Regs & Eggs, in its proposed 2021 physician fee schedule, the Centers for Medicare & Medicaid Services (CMS) proposes delaying this EPCS requirement to 2022 due the ongoing response to the COVID-19 public health emergency. ACEP supports this delay.

However, CMS also released a separate request for information (RFI) on how it should implement the requirement going forward. In this RFI, CMS seeks comments on three issues: 1) compliance with the requirement; 2) enforcement and penalties; and 3) potential exceptions to the requirement.

Last week, ACEP submitted a detailed response to the RFI—particularly focusing on the burden associated with EPCS and whether an exception should be granted to emergency physicians in certain cases.

First, we specifically pointed out the hurdles you as emergency physicians have experienced getting registered and implementing EPCS into your workflows. In most cases, in order to electronically prescribe controlled substances, you must use an institution-approved application that is installed on your smartphone for “two-factor authentication.” Two-factor authentication—which is generally required for EPCS—means you have to go through two security layers in order to e-prescribe. The process for getting the app put on to your cell phone is burdensome and time-consuming, adding to the endless list of non-clinical tasks you must complete as a physician. When you purchase a new smartphone, you are required to visit the credentialing office and obtain a new helpdesk ticket and a new credentialing of the app. Then, that credential must be tied to the electronic health record (EHR) for two-factor authentication. Further, if you lose a smartphone, you have to re-enroll—and since that process takes time and an in-person office visit, often you cannot e-prescribe for days to weeks afterwards.

ACEP also believes that having to undergo a two-factor authentication process before being able to e-prescribe controlled substances may be unnecessary and perhaps superfluous in settings that already have strict security protocols in place. Overly burdensome security procedures in general pose a barrier to the adoption of EHRs and other health IT platforms and may create a disincentive to prescribe the most medically appropriate drug for a patient.

Beyond the burden associated with EPCS, there are also factors that are specific to care provided in the emergency department (ED) that we believe CMS must take into consideration when implementing the Medicare requirement. Luckily, the SUPPORT Act does specify some circumstances under which CMS may waive the EPCS requirement—including cases where the prescriber reasonably determines it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner and the if delay would adversely impact the individual’s medical condition.

In our response, ACEP argues that this specific exclusion applies regularly to patients who seek treatment in EDs. As you are well aware, the majority of ED visits fall outside of “business hours,” and some of your patients may have a regular pharmacy. Thus, many e-prescriptions are prone to “failure;” meaning, the pharmacy hours are not convenient for the patient or the prescribed drug may not be in stock. This usually requires the patient to return to the ED or call you as the prescriber to cancel the original prescription and re-issue it to a new pharmacy. If your ED shift has ended, a new prescriber must be recruited, which either prompts a new and avoidable ED visit or pulls a clinician away from current emergency patients. Emergency physicians especially may have trouble electronically prescribing controlled substances in rural areas. In some areas of the country, there are no 24-hour pharmacies. Pharmacy hours can change frequently and getting even non-controlled prescriptions to an open pharmacy that the patient can use is problematic after business hours.

Further, we believe that in some cases, patients have a better chance of filling a prescription if they have a paper prescription in hand. Sometimes, patients who are electronically prescribed a controlled substance show up at the wrong pharmacy and it can be burdensome for you to get the prescription transferred.

All in all, we ask that CMS create an exception for emergency physicians in cases where you feel, using your clinical judgment, that issuing an electronic prescription for a controlled substance would be logistically challenging and/or decrease the likelihood that their patient will actually get their prescription filled.

Finally, we recommend that CMS coordinate policies with the Drug Enforcement Administration (DEA). The DEA is responsible for establishing requirements for prescribing and dispensing controlled substances. Interestingly, the agency recently decided to reopen a previous EPCS regulation for comments. ACEP appreciated the opportunity to comment on that reg since as a lot has changed since it was first released ten years ago. We submitted responses to specific technical questions posed by the DEA. Going forward, we hope that the DEA and CMS work together to ensure the final implementation timeline adopted by CMS for Medicare prescriptions takes into account the DEA’s timeframe for implementing new regulations. Physicians and health care institutions will need sufficient time between when the DEA issues any revised regulations and when CMS decides to implement the Medicare requirement to update their systems or acquire new technology if needed to comply with the DEA requirements.

While CMS may wind up delaying the EPCS requirement to 2022 (or perhaps even later), we hope that in the meantime CMS takes our recommendations into consideration. We will continue to keep you posted on this requirement and what exceptions are granted for you as emergency physicians.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs!

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