[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Proposed Rules]
[Pages 47151-47157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 423

[CMS-3394-NC]
RIN 0938-AU25


Medicare Program: Electronic Prescribing of Controlled 
Substances; Request for Information (RFI)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Request for information.

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SUMMARY: Section 2003 of the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment for Patients and Communities Act 
(SUPPORT Act) requires generally that prescriptions for controlled 
substances covered under a Medicare Part D prescription drug plan or 
Medicare Advantage Prescription Drug Plan (MA/PD) be transmitted by a 
health care practitioner electronically in accordance with an 
electronic prescription drug program, beginning January 1, 2021. 
Further, section 2003 of the SUPPORT Act provides CMS with the 
authority to, through rulemaking, enforce and specify appropriate 
penalties for noncompliance with the requirement for electronic 
prescribing of controlled substances (EPCS). The SUPPORT Act requires 
CMS to specify, through rulemaking, circumstances and processes by 
which it may waive the EPCS requirement. This Request for Information 
(RFI) seeks input from

[[Page 47152]]

stakeholders about whether CMS should include exceptions to the EPCS 
and under what circumstances, and whether CMS should impose penalties 
for noncompliance with this mandate in its rulemaking, and what those 
penalties should be.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided in the ADDRESSES section, no later than 5 p.m. 
on October 5, 2020.

ADDRESSES: In commenting, refer to file code CMS-3394-NC.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the `` ``Submit a 
comment'' '' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3394-NC, P.O. Box 8013, Baltimore, MD 
21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3394-NC, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Ashley Hain, (410) 786-7603, for 
general inquiries related to the RFI. Joella Roland, (410) 786-7638, 
for Part D electronic-prescribing issues.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

I. Background

    In 2018, President Trump signed the Substance Use-Disorder 
Prevention that Promotes Opioid Recovery and Treatment for Patients and 
Communities Act, or the SUPPORT for Patients and Communities Act, into 
law, which mobilized Federal efforts to address the nation's ongoing 
opioid crisis. Section 2003 of the SUPPORT Act mandates that the 
prescribing of a Schedule II, III, IV, or V controlled substance under 
Medicare Part D should be done electronically in accordance with an 
electronic prescription drug program, beginning 2021, subject to any 
exceptions, which the Department of Health and Human Services (HHS) may 
specify. The circumstances that are listed in the statute under which 
the Secretary may waive the EPCS requirement are at section 1860D-
4(e)(7) of the Act, as added by section 2003 of the SUPPORT Act, and 
include--
     A prescription issued when the practitioner and dispensing 
pharmacy are the same entity;
     A prescription issued that cannot be transmitted 
electronically under the most recently implemented version of the 
National Council for Prescription Drug Programs SCRIPT Standard;
     A prescription issued by a practitioner who received a 
waiver or a renewal thereof for a period of time as determined by the 
Secretary, not to exceed one year, from the requirement to use 
electronic prescribing due to demonstrated economic hardship, 
technological limitations that are not reasonably within the control of 
the practitioner, or other exceptional circumstance demonstrated by the 
practitioner;
     A prescription issued by a practitioner under 
circumstances in which, notwithstanding the practitioner's ability to 
submit a prescription electronically as required by this subsection, 
such practitioner reasonably determines that it would be impractical 
for the individual involved to obtain substances prescribed by 
electronic prescription in a timely manner, and such delay would 
adversely impact the individual's medical condition involved;
     A prescription issued by a practitioner prescribing a drug 
under a research protocol;
     A prescription issued by a practitioner for a drug for 
which the Food and Drug Administration requires a prescription to 
contain elements that are not able to be included in electronic 
prescribing, such as a drug with risk evaluation and mitigation 
strategies that include elements to assure safe use;
     A prescription issued by a practitioner--
    ++ For an individual who receives hospice care under title XVIII; 
and
    ++ That is not covered under the hospice benefit under title XVIII; 
and
     A prescription issued by a practitioner for an individual 
who is--
    ++ A resident of a nursing facility (as defined in section 1919(a) 
of the Act); and
    ++ Dually eligible for benefits under titles and XVIII and XIX.
    Since Part D was signed into law in 2003, electronic prescribing 
(e-prescribing or e-Rx) has been optional for physicians with respect 
to prescriptions made for covered Part D drugs. However, Part D 
sponsors offering drug plans have been required to have the electronic 
capabilities to support electronic prescribing. CMS adopted the first 
set of standards for e-prescribing for Part D in 2005.\1\ Those 
standards included the National Council for Prescription Drug Programs 
(NCPDP) SCRIPT Standard Version 5, Release 0. Since then, CMS has 
continued to adopt updated e-prescribing standards \2\ with the most 
recent standard described in a final rule published April 16, 2018, 
where CMS finalized its update of its Part D standards to NCPDP SCRIPT 
standard version 2017071 for e-Rx and medication history, effective 
January 1, 2020 (83 FR 16440).
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    \1\ See 70 FR 67568.
    \2\ CMS regulations adopting updated versions of the NCPDP 
SCRIPT standard: 73 FR 18918 (NCPDP SCRIPT version 8.1) and 77 FR 
688892 (NCPDP SCRIPT version 10.6).
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    We maintain a prescription drug events (PDEs) system to capture 
Part D prescriptions processed (see OMB Control Number 0938-0982). The 
PDE format includes a field in which the plan must indicate whether the 
prescription was written via paper, electronic or telephonic means. CMS 
has collected data on controlled substances and non-controlled 
substances since the Drug Enforcement Agency (DEA) permitted the 
electronic prescribing of controlled substances in 2010.\3\
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    \3\ See 75 FR 16284, including revisions adopted to 21 CFR 
1304.04.
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    However, as HHS and other Federal departments and agencies work to 
implement various provisions of the SUPPORT Act, including the 
electronic prescribing requirements for controlled substances under 
Part D, the health care system faces new challenges. The United States 
is currently responding to an outbreak of respiratory disease caused by 
a novel (new) coronavirus now detected in 50 States and the District of 
Columbia. This virus has been named ``severe acute respiratory syndrome 
coronavirus 2'' (``SARS-CoV-2''), and the disease it causes has been 
named ``coronavirus disease 2019''

[[Page 47153]]

(``COVID-19''). In January 2020, HHS Secretary Alex M. Azar II 
determined that a Public Health Emergency (PHE) exists for the United 
States to aid the nation's health care community in responding to 
COVID-19 (hereafter referred to as the PHE for the COVID-19 pandemic), 
and on April 21, 2020, Secretary Azar renewed, effective April 26, 
2020, the determination that a PHE exists. In March 2020, President 
Trump declared the COVID-19 pandemic a national emergency. Certain 
individuals, including older adults and persons with chronic 
conditions, who comprise a predominance of the Medicare beneficiary 
population, are at elevated risk of more severe illness and potential 
death from COVID-19. The Centers for Disease Control's guidance on the 
COVID-19 pandemic notes that ``people in their 50s are at higher risk 
for severe illness than people in their 40s. Similarly, people in their 
60s or 70s are, in general, at higher risk for severe illness than 
people in their 50s. The greatest risk for severe illness from COVID-19 
is among those aged 85 or older.'' \4\ As a result of the PHE, and as 
the nation reopens, some individuals, such as those who are at high 
risk, may continue to practice self-isolation and social distancing.\5\
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    \4\ See https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html.
    \5\ See https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/social-distancing.html.
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    We have taken many regulatory and policy actions to swiftly aid the 
nation's health care system to address effectively the COVID-19 
pandemic. These actions include new flexibilities for telehealth and 
other electronic technologies \6\ to ease the burden on providers and 
help assure appropriate and safe care in a range of settings for 
beneficiaries. Also, DEA has adopted certain new temporary 
flexibilities to allow DEA-registered practitioners to prescribe 
controlled substances without having to interact in person with some 
patients, effective for the duration of the PHE.\7\ DEA's COVID-19 
information page may be found at: https://www.deadiversion.usdoj.gov/coronavirus.html. DEA has acknowledged the prevalence of paper 
prescribing of controlled substances and attempted to address some of 
the hardships it poses for prescribers and patients during the PHE. We 
believe that social distancing is, in part, responsible for the 
increase in EPCS during this PHE. In 2020, electronic prescribing 
increased to 50 percent of all PDEs being prescribed as compared to 38 
percent in 2019.\8\ 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. Some 
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. Pharmacies that 
were not previously doing so may deliver medications, or deliver at no 
charge, and communities and individuals have worked together to design 
ways for vulnerable persons to continue to receive access to prescribed 
medications in tandem with these new government and private sector 
flexibilities.
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    \6\ See https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.
    \7\ See https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
023)(DEA075)Decision_Tree_(Final)_33120_2007.pdf.
    \8\ Based on Prescription Drug Event data processed through 
April 30, 2020.
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    DEA has the primary responsibility for establishing requirements 
for prescribing and dispensing of controlled substances. In 2010, DEA 
issued an Interim Final Rule with Request for Comment, ``Electronic 
Prescriptions for Controlled Substances,'' that provided practitioners 
with the option of writing prescriptions for controlled substances 
electronically (75 FR 16236). The rule also permitted pharmacies to 
receive, dispense, and archive these electronic prescriptions. Any 
electronic controlled substance prescription issued by a practitioner 
must meet the requirements in DEA's EPCS interim final rule. On April 
21, 2020, DEA reopened the 2010 interim final rule to solicit comments 
from the public on specific EPCS-related issues.\9\
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    \9\ See https://www.federalregister.gov/documents/2020/04/21/2020-07085/electronic-prescriptions-for-controlled-substances.
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    Since the issuance of DEA's EPCS interim final rule in 2010, CMS 
has seen a steady increase in the volume of controlled substance 
prescriptions submitted electronically. For example, in 2018, 26.57 
percent of controlled substance prescription drug events (PDEs) were 
transmitted electronically. In 2019, e-prescribing for controlled 
substances PDEs increased to 37.31 percent. However, in our 2020 data, 
51.15 percent of those PDEs have been transmitted electronically. 
States have instituted electronic prescribing requirements; some 
include penalties for not using e-prescribing for controlled 
substances. As of 2020, all states in the U.S. and the District of 
Columbia allow electronic prescribing of controlled substances for 
schedules II through V.\10\
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    \10\ Schedule I drugs are not included in EPCS discussions 
because they have no currently accepted medical use. See https://www.deadiversion.usdoj.gov/schedules/#define for additional detail 
on definitions of controlled substances.
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    EPCS provides multiple advantages over the traditional processing 
of prescriptions.\11\ In addition to improving workflow efficiencies, 
electronic prescribing of controlled substances can deter and help 
detect prescription fraud and irregularities by requiring an extra 
layer of identity proofing, two-factor authentication and digital 
signature processes. It can also provide more timely and accurate data 
than paper prescriptions. By allowing for the direct transmission of 
electronic prescriptions for controlled substances between providers 
and pharmacies or facilities, EPCS may also reduce the burden on 
prescribers who need to coordinate and manage paper prescriptions 
between staff, patients, facilities, other care sites, and pharmacies. 
In addition, EPCS data is transmitted to Prescription Drug Monitoring 
Programs (PDMPs), which can help inform providers of patients' 
medication history at the time of prescribing. It is also important to 
continue the assurance of privacy and

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security in the prescribing process, such as by controlling prescriber 
access through improved identity controls and authentication protocols. 
EPCS can assure prescribers' identity more easily and may permit a 
single workflow for prescribing both controlled and non-controlled 
drugs, improving the overall prescribing process.\12\
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    \11\ Phillips et. al. ``Market Guide for Identity Proofing and 
Corroboration.'' April 24, 2018. Gartner, Inc. Retrieved from 
https://www.fedscoop.com/gartner-guide-identity-proofing-corroboration-2018/ on April 30, 2020. Ryan, D. ``FinCEN: Know Your 
Customer Requirements.'' February 7, 2016. Harvard Law School Forum 
on Corporate Governance. Retrieved from https://corpgov.law.harvard.edu/2016/02/07/fincen-know-your-customer-requirements/#2b on April 30, 2020. Nix, M. ``Five Questions: Ken 
Whittemore Talks Past, Present & Future of E-Prescribing Controlled 
Substances.'' March 31, 2020. SureScripts. Retrieved from https://surescripts.com/news-center/intelligence-in-action/opioids/five-questions-ken-whittemore-talks-past-present-future-of-e-prescribing-controlled-substances?utm_campaign=IIA percent2FBlog 
percent20Subscription&utm_source=hs_email&utm_medium=email&utm_conten
t=85955401&_hsenc=p2ANqtz-8xs36u7xTFZ-
ieOxJk3309SApbE7to_fnk1SZvz2jqwz0pA3k7TtW9byiOq2zBlheLInMOeajCMCKeQUT
zcEDP79HEaeXI52QiadhAYAWU3Px2eZc&_hsmi=85955401 on April 30, 2020. 
Zhang et. al. ``T2FA: Transparent Two-Factor Authentication.'' June 
15, 2018. IEEE Access. Retrieved from https://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=8386653 on April 30, 2020. Konoth R.K., 
van der Veen V., Bos H. (2017) How Anywhere Computing Just Killed 
Your Phone-Based Two-Factor Authentication. In: Grossklags J., 
Preneel B. (eds) Financial Cryptography and Data Security. FC 2016. 
Lecture Notes in Computer Science, vol 9603. Springer, Berlin, 
Heidelberg. Retrieved from https://link.springer.com/chapter/10.1007 
percent2F978-3-662-54970-4_24 on April 30, 2020. Cal and Zhu. 
``Fraud detections for online businesses: a perspective from 
blockchain technology.'' Financial Innovation (2016) 2:20. Retrieved 
from https://link.springer.com/content/pdf/10.1186/s40854-016-0039-4.pdf on April 30, 2020.
    \12\ HHS Office of the National Coordinator, The ONC Doctors' 
Perspective: Electronic Prescribing of Controlled Substances (EPCS) 
Is on the Rise, and We Must Work Together to Address Barriers to 
Use: https://www.healthit.gov/buzz-blog/health-it/the-onc-doctors-perspective-electronic-prescribing-of-controlled-substances-epcs-is-on-the-rise-and-we-must-work-together-to-address-barriers-to-use
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    From the patient standpoint, EPCS may reduce the logistical burden 
on patients who may otherwise be required to make multiple trips 
between providers and pharmacies to transport paper prescriptions when 
filling time-sensitive prescriptions while in pain or otherwise in need 
of treatment with controlled substances, as Schedule II, III, IV, or V 
drugs that may be used to treat a number of conditions. EPCS can lessen 
the time needed to obtain prescriptions by minimizing trips to the 
physician to pick up paper prescriptions for refills, minimize 
transportation costs to and from the provider's office, and even help 
lessen stigma, well-known to be associated with chronic pain when 
opioid therapy is used as a treatment modality.\13\ EPCS' security 
advantages also assure prescribers, patients, and pharmacies that 
prescriptions are processed as intended. In addition to helping with 
the reduction in fraud previously described, EPCS minimizes the 
likelihood that prescriptions have been tampered with, since electronic 
prescriptions are securely transmitted directly to the pharmacy from 
health information technology, which minimizes the likelihood of 
exposure to patients or other third parties with potentially malicious 
intent.
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    \13\ Department of Health and Human Services Pain Management 
Best Practices Inter-Agency Task Force Report, May 2019: https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
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II. Solicitation of Public Comments

    We are issuing this RFI and requesting comment from stakeholders 
regarding how the SUPPORT Act's EPCS requirements can be implemented 
with minimal burden to those prescribers participating in the Part D 
program during and after the PHE. We are committed to helping health 
care providers streamline operations, and want to strongly encourage 
prescriber EPCS adoption across the health care continuum as another 
mechanism to further ease burden, ensure prescribing safety, and 
improve beneficiary health and satisfaction.
    We seek responses to this RFI from beneficiary and advocacy groups; 
beneficiaries and caregivers; primary care and specialty providers; 
health plans and supplemental insurers; state, local, and territorial 
governments; research and policy experts; industry and professional 
associations; long-term care facilities, hospice providers, 
pharmacists, and pharmacy associations; and other interested members of 
the public.
    In the following sections of this RFI, we discuss compliance 
assessments, enforcement (including penalties), and waivers. We seek 
comments in response to questions related to each of these topics in 
each subsection.
    Commenters are requested to provide responses to the following 
questions that are most relevant to their interest and experience. A 
response to every question is not required. Additionally, commenters 
may identify and comment on other issues that they believe are 
significant for CMS to consider in implementing the SUPPORT Act's EPCS 
requirements. Respondents are requested to draw their responses from 
objective, empirical, and actionable evidence and to cite this evidence 
within their responses whenever possible.

A EPCS Compliance Assessments

    Based on a published report of 2019 data reflecting the majority of 
prescribing activities across the country,\14\ 97 percent of U.S. 
pharmacies were capable of processing electronic prescriptions for 
controlled substances, yet only 49 percent of prescribers were capable 
of electronically prescribing controlled substances. The same report 
showed that 38 percent of controlled substance prescriptions were 
electronically prescribed, while 85 percent of non-controlled 
substances were electronically prescribed. Pain management specialists 
appear to be using electronic prescribing for controlled substances 
more often than other prescribers, and family practitioners are using 
electronic prescribing less often. Electronic prescribing also varies 
across practice size and ownership and among physicians who practice in 
groups owned by a health plan, health maintenance organizations, 
hospital, or other healthcare entity. Use of the technology does not 
vary significantly between rural and urban areas, but it does vary 
between states, likely associated with differences in regulations, 
penalties, waivers, populations, and culture.\15\
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    \14\ Surescripts. ``National Progress Report 2019.'' March 2020. 
Retrieved from https://surescripts.com/docs/default-source/national-progress-reports/7398_ab-v2_2019-npr-brochure.pdf on April 20, 2020.
    \15\ HHS Office of the National Coordinator, The ONC Doctors' 
Perspective: Electronic Prescribing of Controlled Substances (EPCS) 
Is on the Rise, and We Must Work Together to Address Barriers to 
Use: https://www.healthit.gov/buzz-blog/health-it/the-onc-doctors-perspective-electronic-prescribing-of-controlled-substances-epcs-is-on-the-rise-and-we-must-work-together-to-address-barriers-to-use.
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    The reasons for this disparity between capability and practice are 
likely to be multifaceted. For instance, we hypothesize that there may 
be challenges associated with some prescribers' ability to 
electronically prescribe controlled substances within their normal 
workflow, and reluctance to alter workflow habits use new technology, 
although the recent COVID-19-related need to shift to remote forms of 
patient care may have already rapidly and substantially altered many 
such preferences. Other prescribers may be dependent on health care 
groups, clinics, or hospital systems to implement the necessary 
technology. There are also costs associated with the adoption of 
technology, which may disproportionately impact small or rural 
practices or pharmacies. Though EPCS uptake continues to grow,\16\ 
based on pre-COVID-19 data, there is clearly more opportunity for 
greater adoption of electronic prescribing of controlled substances.
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    \16\ Burger, M. ``Accelerating ePrescribing for Controlled 
Substances.'' HIT Perspectives: Controlled Substances, February 
2014. Retrieved from https://www.pocp.com/hitperspectives-controlled-substances/ on April 30, 2020. Imambaccus N, Glace S, 
Heath R. Increasing the uptake of electronic prescribing in primary 
care. BMJ Quality Improvement Reports 2017;6:u212185. w4870. 
doi:10.1136/bmjquality.u212185.w4870. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457970/pdf/bmjqir.u212185.w4870.pdf on April 30, 2020. Monegain, B. ``E-
prescribing takes off like a rocket.'' Healthcare IT News, June 18, 
2015. Retrieved from https://www.healthcareitnews.com/news/e-prescribing-takes-rocket on April 30, 2020.
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    Substantial adoption of EPCS has occurred in the thirteen states 
that require it.\17\ Some states have chosen to use penalties to 
increase prescribers' compliance with EPCS requirements. For example, 
New York mandated EPCS with a penalty for non-compliance and 
subsequently experienced an EPCS adoption rate for controlled 
substances of nearly 99 percent for pharmacies and

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82 percent for prescribers in 2019.\18\ CMS does not currently impose 
penalties for providers prescribing controlled substances under the 
Part D program who do not use e-prescribing. Rather, Part D plans may 
reject improper transactions or transactions that do not adhere to the 
CMS transaction standards.
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    \17\ Arizona, Connecticut, Florida, Indiana, Iowa, Maine, 
Minnesota, New York, North Carolina, Oklahoma, Pennsylvania, Rhode 
Island, and Virginia have adopted mandates that will be in effect in 
2020. DrFirst. Mandates Driving EPCS and PDMP Utilization. Accessed 
April 29, 2020. https://drfirst.com/resources/regulatory-mandates/.
    \18\ Surescripts, 2019 National Progress Report. Accessed April 
29, 2020. https://naspa.us/wp-content/uploads/2020/04/7398_2019-NPR-Brochure-Web-Final.pdf.
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    Given that the SUPPORT Act generally mandates electronic 
prescribing of a Schedule II, III, IV, or V controlled substance under 
Medicare Part D, we seek comment on the following specific questions 
with respect to assessing compliance with EPCS requirements:
     What types of challenges might discourage prescribers from 
incorporating electronic prescribing into their normal workflows? How 
could CMS structure its EPCS policy to remove roadblocks to effective 
adoption of electronic prescribing for controlled substances?
     What level of compliance with EPCS would be appropriate to 
require before levying any penalties on a non-compliant prescriber, and 
why? For example, should we consider adopting a percentage of 
prescribers threshold that a practice must meet to be considered 
compliant with EPCS requirements? Should we 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 we communicate information on performance to the prescriber to 
drive improvement?

B. EPCS Enforcement

    Section 2003 of the SUPPORT Act provides authority to the Secretary 
to enforce and specify appropriate penalties for non-compliance with 
the EPCS requirements. To ensure compliance with EPCS mandates, some 
States have imposed penalties for prescribers who fail to use EPCS. For 
example, Pennsylvania enforces prescriber penalties of $100 per 
violation for the first through tenth violations and $250 per violation 
for the eleventh and subsequent violations, up to $5,000 per year.\19\ 
Based on stakeholder experience with the States and their varying 
penalties, we seek comment on what, if any, penalties stakeholders 
believe would be appropriate for non-compliance with a Federal EPCS 
mandate.
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    \19\ Pennsylvania Department of Health Q&A on Act 96 of 2018 and 
applicable Federal requirements, revised 10/31/2019. Retrieved from 
https://www.health.pa.gov/topics/Documents/Programs/PA_EPCS_FAQ.pdf 
on May 1, 2020.
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    We note that the SUPPORT Act places limits on the Secretary's 
authority to require Part D plans, MA organizations offering MA-PD 
plans, or pharmacists to verify that a practitioner has a waiver or is 
otherwise exempt from EPCS requirements,\20\ in addition to language in 
section 1860D-4(e)(7)(C)(ii) of the Act, which ensures that plans may 
cover and pharmacists may dispense covered Part D drugs from otherwise 
valid written, oral, or fax prescriptions, and in section 1860D-
4(e)(7)(C)(iii) of the Act, which ensures that Medicare beneficiaries 
can designate a particular pharmacy to dispense their covered Part D 
drugs. We view those limitations as important protections for Medicare 
beneficiaries that will ensure continued access to needed medications. 
We are interested in feedback from the public about the most 
appropriate ways to encourage EPCS compliance in the face of practical 
limits on real-time compliance enforcement options.
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    \20\ See section 1860D-4(e)(7)(C)(i) of the Social Security Act, 
as added by section 2003 of the SUPPORT Act.
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    Additionally, we seek feedback on how we should implement the EPCS 
requirement for prescribers of Part D drugs who are not enrolled in 
Medicare or Medicaid. We request feedback on what policies would be 
most appropriate within the SUPPORT Act's statutory limits to encourage 
EPCS adoption among prescribers of Part D drugs who are not enrolled in 
Medicare or Medicaid.
    We seek comment on the following specific questions with respect to 
enforcement:
     What penalties, if any, would be appropriate for non-
compliance with a Federal EPCS mandate?
     How may Federal penalties affect EPCS adherence?
     What mechanism(s) should CMS use to enforce penalties 
among non-participating Medicare or Medicaid prescribers?
     Are there other mechanisms CMS can use to encourage non-
participating Medicare or Medicaid prescribers to use EPCS?
     Are there any circumstances under which penalties should 
automatically be waived?
     How should CMS approach design and use of an appeals 
process for enforcement?
     If CMS were to impose civil money penalties, what penalty 
structure (including amounts) should be adopted?
     Should any details about penalties for violations of 
section 2003 of the Support Act be posted publicly? What types of 
details should be included in information available to the public?
     Should CMS assess penalties after some interval following 
implementation of this requirement? If yes, what interval(s)?
     Should CMS assess penalties' severity incrementally based 
on repeat analyses demonstrating lack of improved compliance? If yes, 
please describe what type of analyses would be most effective.
     Should penalties be significant enough that a prescriber 
not eligible for a waiver or exemption would be either forced to comply 
with the electronic prescribing requirement for controlled substances, 
or stop providing such pharmacologic care across all covered classes of 
controlled substances? What are the implications for patients in either 
scenario?

C. EPCS Waivers

    Section 2003 of the SUPPORT Act requires that the Secretary use 
rulemaking to specify circumstances and processes by which the 
Secretary may waive the EPCS requirement.
    We are interested in receiving input on circumstances for which the 
Secretary should waive the EPCS requirement, including those 
circumstances specified by section 2003 of the SUPPORT Act. For 
instance, an ONC Data Brief published in September 2019 \21\ indicated 
that larger physician practices and practices owned by hospitals had 
the highest rates of physician EPCS, suggesting that smaller practices 
may struggle to adopt the technology and practice. As we discuss in the 
following paragraph, we are interested in stakeholder input on any 
waivers and accompanying limits to the waivers that would be 
appropriate, the specific reasons that such waivers and limits may be 
necessary, and any operational or policy considerations that we should 
take into account when considering the need for and adopting waivers in 
connection with the EPCS requirement.
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    \21\ Parasrampuria et. al. ``Electronic Prescribing of 
Controlled Substances among Office-Based Physicians, 2017.'' Office 
of the National Coordinator for Health Information Technology Data 
Brief. Retrieved from https://www.healthit.gov/sites/default/files/page/2019-09/officebasedphysicianelectronicprescribingofcontrolledsubstance2017.pdf on May 20, 2020.
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    The SUPPORT Act specifies some circumstances under which the 
Secretary may waive the electronic prescribing requirement with respect 
to

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controlled substances that are covered Part D drugs and also permits 
HHS to develop other appropriate exceptions. Given the numerous 
benefits of electronic prescribing for prescribers and patients, and in 
accordance with section 2003 of the SUPPORT Act, CMS seeks to define 
any exceptions narrowly. We also want to clarify that all prescribers 
may prescribe electronically (provided it is done in accordance with 
DEA regulations with respect to controlled substances), even if a 
waiver may apply, and we continue to encourage clinicians who prescribe 
to use electronic prescribing. The circumstances that are listed in the 
statute under which the Secretary may waive the EPCS requirement are as 
follows:
     A prescription issued when the practitioner and dispensing 
pharmacy are the same entity. We seek comments on whether this 
exception is necessary, and how these claims may be identified.
     A prescription issued that cannot be transmitted 
electronically under the most recently adopted version of the National 
Council for Prescription Drug Programs (NCPDP) SCRIPT standard. We 
believe that the current adopted standard NCPDP SCRIPT version 2017071 
allows for most electronic prescribing transmissions. We seek comment 
on this assumption and on any specific circumstances in which a 
prescription for a controlled substance could not be transmitted 
electronically under this standard.
     A prescription issued by a practitioner who received a 
waiver for a period of time (not to exceed 1 year) from the SUPPORT 
Act's section 2003 requirement to use electronic prescribing due to 
demonstrated economic hardship, technological limitations that are not 
reasonably within the control of the practitioner, or other exceptional 
circumstance demonstrated by the practitioner. We seek comment on the 
types of economic hardships and technological limitations that would be 
demonstrated to CMS, and what other types of exceptional circumstances 
would qualify.
     A prescription issued by a practitioner under 
circumstances in which, notwithstanding the practitioner's ability to 
submit a prescription electronically, the practitioner reasonably 
determines it would be impractical for the individual involved to 
obtain substances prescribed by electronic prescription in a timely 
manner, and the delay would adversely impact the individual's medical 
condition. We seek comment on the following:
    ++ The types of circumstances that would qualify.
    ++ Whether this must be explicitly conveyed to CMS to ensure 
compliance.
    ++ If CMS should infer that certain circumstances would qualify for 
an exception.
     A prescription issued by a practitioner prescribing a drug 
under a research protocol. We seek comment on the circumstances in 
which this exception is necessary and how CMS would identify these 
prescriptions.
     A prescription issued by a practitioner for a drug for 
which the Food and Drug Administration requires a prescription to 
contain elements that are not able to be included in electronic 
prescribing, such as a drug with risk evaluation and mitigation 
strategies that include elements to assure safe use. We seek comment on 
whether there are any drugs currently under risk evaluation and 
mitigation strategies for which prescriptions are not conveyed 
electronically or cannot be modified for electronic transmittal.
     A prescription issued by a practitioner--
    ++ For an individual who receives Medicare hospice care; and
    ++ That is not covered under the Medicare hospice benefit.
    We seek comment on the circumstances in which this exception is 
necessary, and how this information would be conveyed to CMS.
     A prescription issued by a practitioner for an individual 
who is--
    ++ A resident of a nursing facility; and
    ++ Dually eligible for Medicare and Medicaid.
    We recognize that electronic prescribing for residents in nursing 
facilities can be challenging due to necessary three-way communication 
involving the prescriber, the facility and the pharmacy. Waiting for 
the prescriber to transmit controlled substance prescriptions 
electronically for new admissions could create delays in initiating 
urgent medication therapy because a prescriber could be required to log 
in to the electronic health record or other health IT system to enter a 
complete and compliant prescription and may not have immediate access 
to the system if not on site at the nursing facility. We also recognize 
that early versions of the NCPDP SCRIPT standard, such as NCPDP SCRIPT 
standard version 5.0 and 8.1, did not support the workflows in the 
long-term care setting that require prescribers to issue a prescription 
for a patient to a non-prescriber (such as a nursing facility) that in 
turn forwards the prescription to a dispenser (LTC pharmacy). 
Nonetheless, many key Part D initiatives such as electronic prior 
authorization are anchored within the NCPDP SCRIPT standard version 
2017071. CMS recognizes and is encouraged by the NCPDP's efforts to 
ensure that e-prescribing standards accommodate the unique needs of 
nursing facility residents. As these efforts progress, we believe that 
electronic prescribing will become more widely adopted in these 
settings. Additionally, as nursing residents are at high risk for 
infection, serious illness, and death from COVID-19, we are especially 
interested in how to assure streamlined and timely prescribing. We seek 
comments on our understanding of the persistence of such challenges for 
EPCS in the nursing facility setting and on any other specific 
circumstances which would support this exception.
    Individuals who are dually eligible for Medicare and Medicaid often 
receive care in the home, through home and community-based services 
(HCBS) or home health services, instead of in a facility like a nursing 
facility. We seek comment on whether there are any additional issues, 
gaps, situations or barriers CMS needs to consider in implementing 
section 2003 for dually-eligible beneficiaries receiving HCBS or home 
health services.
    We are also interested in receiving input on any other possible 
exceptions, such as in cases where a practitioner reasonably determines 
it would be impractical for the individual involved to obtain 
controlled substances prescribed using EPCS in a timely manner and the 
delay would adversely impact the individual's medical condition, or 
where EPCS would present an economic hardship. If commenters believe 
such exceptions should apply, please provide details on the 
circumstances that would require the exception, and the reasoning on 
whether the exception should be for a certain timeframe or 
indefinitely, and to whom the exception should apply.

III. Collection of Information Requirements

    Please note, this is a request for information (RFI) only. In 
accordance with the implementing regulations of the Paperwork Reduction 
Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general 
solicitation is exempt from the PRA. Facts or opinions submitted in 
response to general solicitations of comments from the public, 
published in the Federal Register or other publications, regardless of 
the form or format thereof, provided that no person is required to 
supply specific information pertaining to the

[[Page 47157]]

commenter, other than that necessary for self-identification, as a 
condition of the agency's full consideration, are not generally 
considered information collections and therefore not subject to the 
PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This RFI does not commit the U.S. 
Government to contract for any supplies or services or make a grant 
award. Further, we are not seeking proposals through this RFI and will 
not accept unsolicited proposals. Responders are advised that the U.S. 
Government will not pay for any information or administrative costs 
incurred in response to this RFI; all costs associated with responding 
to this RFI will be solely at the interested party's expense. We note 
that not responding to this RFI does not preclude participation in any 
future procurement, if conducted. It is the responsibility of the 
potential responders to monitor this RFI announcement for additional 
information pertaining to this request. In addition, we note that CMS 
will not respond to questions about potential policy issues raised in 
this RFI.
    We will actively consider all input as we develop future regulatory 
proposals or future subregulatory policy guidance. We may or may not 
choose to contact individual responders. Such communications would be 
for the sole purpose of clarifying statements in the responders' 
written responses. Contractor support personnel may be used to review 
responses to this RFI. Responses to this notice are not offers and 
cannot be accepted by the Government to form a binding contract or 
issue a grant. Information obtained as a result of this RFI may be used 
by the Government for program planning on a non-attribution basis. 
Respondents should not include any information that might be considered 
proprietary or confidential. This RFI should not be construed as a 
commitment or authorization to incur cost for which reimbursement would 
be required or sought. All submissions become U.S. Government property 
and will not be returned. In addition, we may publicly post the public 
comments received or a summary of those public comments.

    Dated: July 20, 2020.
Demetrios Kouzoukas,
Principal Deputy Administrator for Medicare, Centers for Medicare & 
Medicaid Services.
    Dated: July 29, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-16897 Filed 7-30-20; 4:15 pm]
BILLING CODE 4120-01-P