[Submitted electronically to www.regulations.gov]
Seema Verma, Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Re: CMS–3394–NC: Medicare Program: Electronic Prescribing of Controlled Substances; Request for Information (RFI)
Dear Administrator Verma:
ASHP (American Society of Health-System Pharmacists) is pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Request for Information on electronic prescribing (e-prescribing) of controlled substances (EPCS). ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings, including hospitals, health systems, and clinics. The organization’s nearly 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
ASHP thanks CMS for the opportunity to comment on the Request for Information. We hope that our feedback will assist CMS in implementing the e-prescribing requirements.
As noted in our comments on the CY 2021 Physician Fee Schedule, we are generally supportive of EPCS. However, we encourage CMS to provide flexibility on the implementation timeline. Given the unprecedented challenges that the ongoing public health emergency (PHE) has created for providers, we remain concerned that even the January 1, 2022 date might be out of reach for some under-resourced providers. Thus we urge the agency to consider a period of enforcement discretion, including a suspension of non-compliance penalties, extending into 2022. CMS should also be ready to extend the deadline for all providers should there be another major surge in COVID-19 late this year or in 2021.
While considering implementation of the EPCS, we urge CMS to take into account the following issues:
- Vendor capacity: Providers will rely heavily on their electronic health records (EHR) vendors to provide the necessary functionality updates to allow for EPCS. Because so many hospitals and health systems use the same small pool of vendors, we are concerned that vendors may not be able to provide all upgrades and functionality in a timely fashion. In addition, for small and rural hospitals as well as for some physician practices, the additional expenses for these add-on functionalities might be insurmountable, particularly considering the costs many of them have borne during the PHE. We encourage the agency to work with these smaller, less resourced providers to extend the deadline through enforcement discretion or other means.
- Staff Training and Workflow Integration: Although pharmacies are generally ready for EPCS, many prescribers are less prepared. For practices that are just adopting the new EHR functionalities and add-ons, staff will need to be properly trained on processes. This is not a small undertaking – the Drug Enforcement Agency requirements for EPCS are extensive and will be a considerable shift from established workflows. Further, providers may need to train staff on multiple systems, given that the EHRs may vary from site to site (even in the same health system) and may not be interoperable. Finally, state level requirements that differ from the federal EPCS rules may require additional education and training. Because the PHE has upended provider priorities for most of this calendar year, providers may have been forced to postpone this training.
- Penalty Waivers: As noted above, we encourage CMS to consider a period where all noncompliance penalties are waived for those providers who are unable to meet the 2022 deadline. As a general rule, penalties should be waived for provider who makes a good faith effort to comply with EPCS requirements. Further, providers should have access to an appeals process before any noncompliance penalties are levied.
ASHP appreciates the opportunity to offer our input and suggestions on the RFI. Please do not hesitate to contact me at 301-664-8698 or email@example.com if ASHP can provide any further information or assist CMS in any way.
Jillanne Schulte Wall, J.D.
Senior Director, Health & Regulatory Policy