Federal officials are seeking comments about challenges clinicians may face in meeting a January 1, 2021, deadline for electronic submission of prescriptions for opioids covered by Medicare’s Part D pharmacy benefit.
The Centers for Medicare & Medicaid Services (CMS) on Thursday posted a request for information soliciting feedback from clinicians, insurance officials, and the public.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) of 2018 mandates a drive toward electronic prescriptions to deter fraud and to allow better tracking through prescription drug monitoring programs.
However, the law also allows CMS some flexibility in its enforcement of rules regarding electronic prescribing of controlled substances (EPCS). To that end, CMS is asking for comments addressing specific questions, including:
What level of compliance with EPCS would be appropriate to require before levying any penalties for noncompliance and why? Should CMS, for example, consider adopting a percentage-of-prescribers threshold that a practice must meet to be considered compliant with EPCS requirements? Should the agency instead consider specifying a number or percentage of a practice’s patients?
What time period (or periods) should CMS use to evaluate compliance (for example, quarterly, semi-annually, annually) and how should the agency communicate information on performance to the prescriber to drive improvement?
There may be a significant number of clinicians still unprepared for this transition to electronic prescribing of controlled substances, despite significant recent gains in this approach, according to CMS’ request for information.
A published report of 2019 data on prescribing activities across the country showed that 97% of US pharmacies “were capable of processing electronic prescriptions for controlled substances” but only 49% of prescribers could electronically prescribe these substances, CMS wrote.
The request for information is scheduled to appear in the Federal Register on August 4. That publication will open a 60-day period for comments on this request.
In the request for information, CMS noted that there already has been a significant shift toward electronic prescriptions, a trend that accelerated during the COVID-19 pandemic.
State regulations also have played a role in this. Electronic transmission of “controlled substance prescription drug events” rose from 26.6% in 2018 to 37.3% in 2019, CMS reported. In data gathered so far for 2020, that figure has risen to 51.5%.
“With the use of electronic prescribing, a patient and provider can conduct a visit via telehealth and then have the prescription electronically transmitted to the pharmacy without having to see each other in-person and risk transmitting COVID-19,” CMS notes in the request for information.
Insurers, including Part D plans, may be permitting medication refills, including for controlled substances, earlier than usual or for a more extended period of time than was previously allowed, the agency said.
Need for DEA Involvement
Much of the enforcement of the SUPPORT Act rests with the US Drug Enforcement Administration (DEA).
In a June 22 letter to the DEA, James L. Madara, MD, chief executive officer of the American Medical Association (AMA), asked the agency to “examine methods to reduce regulatory complexity that detracts from health IT innovation” needed to help address the opioid crisis.
“Modernization of the EPCS rules has taken on heightened urgency this year as the country faces not one but two nationwide public health emergencies,” Madara wrote, referring to the pandemic as well as the persisting opioid crisis.
“The need for patients and physicians to replace paper with electronic prescriptions has never been greater as physicians and pharmacies work to adopt stringent infection control practices, including avoiding physical contact and maintaining social distancing,” he added.
Last year, the AMA pressed one of the largest US retailers, Walmart, to drop a plan to require only electronic submission of controlled substance prescriptions by January 1, 2020.
Walmart was seeking to cut off use of paper prescriptions a year ahead of the CMS schedule for Part D. However, in December 2019, Walmart dropped its plan.