Response to Comment

Attachment A
CMS Response to Public Comments Received for CMS-10834
The Centers for Medicare and Medicaid Services (CMS) received two comments.
Responses are below.
Comment #1:
Comment:
The commenter, a pediatric nurse practitioner (PNP) student, interprets the estimate of 52
burden hours to mean that each prescriber would need to spend more than 52 hours
completing a waiver application. The commenter also expresses concern that the 306
estimated waivers represent an excessive burden for individual practitioners, particularly
those in small, independent, or rural practices. The commenter additionally raises
questions about applicability to pediatric settings, and notes concerns regarding waiver
duration and the renewal process.
Response:
We appreciate the commenter’s feedback and the perspective shared as a pediatric nurse
practitioner (PNP) student. The figure 306 represents the estimated number of individuals
nationwide who are expected to submit a waiver application each year. It does not reflect
the burden on any single practitioner or practice.
Similarly, the 52 total burden hours shown in the Supporting Statement represent the
combined annual burden across all respondents. Each waiver application is estimated to
require approximately 0.17 hours (about 10 minutes). When multiplied by the projected
306 respondents, this results in an aggregated annual burden of 52 hours.
We also note the commenter’s concerns regarding smaller or resource-limited practices.
CMS finalized a small prescriber exemption, which reduces burden for practices with low
volumes of Medicare Part D prescriptions. In addition, the EPCS requirements apply only
to Medicare Part D controlled substance claims. Because very few pediatric patients are
enrolled in Medicare Part D, pediatric-specific prescribing workflows generally fall
outside the scope of this requirement.
The commenter also raised questions regarding waiver duration and the renewal process.
Information on waiver timeframes, renewals, and related processes is available on the
CMS EPCS Program webpage, which serves as the central resource for guidance and
program updates.

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Comment #2:
Comment:
The commenter supports CMS’s proposal to require electronic prescribing of controlled
substances under Medicare Part D, citing benefits for fraud reduction and improved
accuracy. The commenter also notes that smaller or resource-limited practices may face
challenges adopting the required technology and recommends that CMS provide support
or consider a phased transition.
Response:
We appreciate the commenter’s support for implementing electronic prescribing of
controlled substances. CMS agrees that electronic prescribing enhances program integrity
and patient safety by reducing fraud, minimizing errors, and ensuring secure transmission
of prescriptions.
CMS also acknowledges the commenter’s concerns regarding smaller or resource-limited
practices. CMS considered these challenges in prior rulemaking and established a small
prescriber exemption, which reduces burden for providers who write a low volume of
Medicare Part D controlled substance prescriptions. This exemption is intended to
address the unique operational constraints that small practices may face.
In addition, CMS implemented a phased compliance approach to provide additional time
for system upgrades and workflow adjustments. This approach helps ensure that
providers have adequate time to prepare for the transition while the program continues
advancing the benefits of electronic prescribing.
CMS appreciates the commenter’s recommendations and will continue implementing the
EPCS requirements in a manner that supports provider readiness and promotes safe,
modern prescribing practices.

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