DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 423
Office of the Secretary
45 CFR Part 170
[CMS-4205-F2]
RIN 0938-AV24
Medicare Program; Medicare Prescription Drug Benefit Program; Health Information
Technology Standards and Implementation Specifications
AGENCY: Centers for Medicare & Medicaid Services (CMS), Office of the National
Coordinator for Health Information Technology (ONC), Department of Health and Human
Services (HHS).
ACTION: Final rule.
SUMMARY: This final rule will revise the Medicare Prescription Drug Benefit (Part D) and
ONC regulations to implement changes related to required standards for electronic prescribing
and adoption of health information technology (IT) standards for HHS use.
DATES: These regulations are effective [INSERT DATE 30 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER]. The incorporation by reference of certain
publications listed in the rule is approved by the Director of the Federal Register as of [INSERT
DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. The
incorporation by reference of certain other publications listed in the rule was approved by the
Director as of January 1, 2014, June 15, 2018, and June 30, 2020.
FOR FURTHER INFORMATION CONTACT:
Maureen Connors, (410) 786-4132 – Part D Standards for Electronic Prescribing.
Alexander Baker, (202) 260-2048 – Health IT Standards.
SUPPLEMENTARY INFORMATION:

I. Background
In this final rule, CMS and ONC address remaining proposals from the proposed rule
titled “Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program,
and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards
and Implementation Specifications” (88 FR 78476), which appeared in the November 15, 2023
Federal Register (hereinafter referred to as the “November 2023 proposed rule”) that were not
finalized.
We are finalizing changes to Part D requirements for electronic prescribing standards so
that the standards required by CMS meet the needs of the health care industry. To promote
alignment across HHS, in this final rule, we will require Part D sponsors, prescribers, and
dispensers of covered Part D drugs for Part D eligible individuals to comply with standards CMS
has either adopted directly or is requiring by cross-referencing standards ONC adopts for
electronically transmitting prescriptions and prescription-related information.
Under current requirements, Part D sponsors, prescribers, and dispensers of covered Part
D drugs for Part D eligible individuals are required to comply with the National Council for
Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 for electronically
transmitting prescriptions and prescription-related information, medication history information,
and electronic prior authorization (ePA); and the NCPDP Formulary and Benefit (F&B) standard
version 3.0 for electronically transmitting formulary and benefit information. Part D sponsors
also are required to implement one or more electronic real-time benefit tools (RTBTs) capable of
integrating with at least one prescriber’s electronic prescribing system or electronic health record
(EHR), but CMS does not currently require compliance with a standard for RTBTs.
ONC is adopting NCPDP SCRIPT standard version 2023011, NCPDP F&B standard
version 60, and NCPDP Real-Time Prescription Benefit (RTPB) standard version 13 for HHS

use. ONC is also revising its regulation so that NCPDP SCRIPT standard version 2017071 will
expire for the purposes of HHS use on January 1, 2028.
As finalized, Part D standards for electronic prescribing regulations will indicate that
prescriptions, medication history, and ePA must comply with a standard adopted by ONC, which
will include the NCPDP SCRIPT standard version 2017071 and NCPDP SCRIPT standard
version 2023011 standards. Taken in conjunction with the January 1, 2028 expiration date for
NCPDP SCRIPT standard version 2017071 that ONC finalizes in this final rule, entities will be
permitted to use either version of the NCPDP SCRIPT standard until NCPDP SCRIPT standard
version 2017071 expires. Therefore, as of January 1, 2028, entities will be required to
exclusively use NCPDP SCRIPT standard version 2023011.
With respect to electronic transmission of formulary and benefits information, we are
finalizing the requirement that Part D sponsors, prescribers, and dispensers of covered Part D
drugs for Part D eligible individuals can use NCPDP F&B standard version 3.0 or comply with a
standard adopted by ONC, which finalizes its adoption of NCPDP F&B standard version 60 in
this final rule. However, we are finalizing the requirement that, beginning January 1, 2027, these
entities must comply with a standard adopted by ONC only. Therefore, as of January 1, 2027,
Part D sponsors, prescribers, and dispensers of covered Part D drugs for Part D eligible
individuals will be required to exclusively use NCPDP F&B standard version 60 for the
electronic transmission of formulary and benefits information.
Additionally, we are finalizing a requirement that by January 1, 2027, Part D sponsor
RTBTs must comply with a standard adopted by ONC, which finalizes its adoption of NCPDP
RTPB standard version 13 in this final rule.
This final rule also finalizes a provision that, while not changing requirements, will crossreference Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations in
45 CFR part 162 for eligibility transactions so that Part D requirements will automatically align

with any potential future updates to the required standards for eligibility transactions. This final
rule also reorganizes requirements and makes technical changes throughout § 423.160.
II. Enhancements to the Medicare Prescription Drug Benefit Program
A. Standards for Electronic Prescribing (§ 423.160)
1. Legislative Background
Section 1860D–4(e) of the Social Security Act (the Act) requires the adoption of Part D
electronic prescribing (or e-prescribing) standards. Part D sponsors are required to establish
electronic prescription drug programs that comply with the e-prescribing standards that are
adopted under this authority. For a further discussion of the statutory requirements at section
1860D–4(e) of the Act, refer to the proposed rule titled “Medicare Program; E-Prescribing and
the Prescription Drug Program,” which appeared in the February 4, 2005 Federal Register (70
FR 6255). Section 6062 of the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (Pub. L. 115–271), hereinafter
referred to as the SUPPORT Act, amended section 1860D–4(e)(2) of the Act to require the
electronic transmission of ePA requests and responses for the Part D e-prescribing program to
ensure secure ePA request and response transactions between prescribers and Part D sponsors for
covered Part D drugs prescribed to Part D eligible individuals. Such electronic transmissions
must comply with technical standards adopted by the Secretary. Section 119(a) of Subtitle B of
Title I, Division CC of the Consolidated Appropriations Act, 2021, (CAA, 2021) added section
1860D-4(o) of the Act to require, after the Secretary has adopted a standard under section
1860D-4(o)(3) of the Act and at a time determined appropriate by the Secretary, Part D sponsors
to implement one or more electronic RTBTs meeting the requirements described in section
1860D-4(o)(2) of the Act. There is generally no requirement that Part D prescribers or dispensers
implement e-prescribing, with the exception of required electronic prescribing of Schedule II, III,
IV, and V controlled substances that are Part D drugs, consistent with section 1860D-4(e)(7) of
the Act as added by section 2003 of the SUPPORT Act and as specified at § 423.160(a)(5).

However, prescribers and dispensers who electronically transmit and receive prescription and
certain other information regarding covered Part D drugs prescribed for Medicare Part D eligible
beneficiaries, directly or through an intermediary, are required to comply with any applicable
standards that are in effect.
2. Regulatory History
As specified at § 423.160(a)(1), Part D sponsors are required to support the Part D eprescribing program transaction standards as part of their electronic prescription drug programs,
as described under § 423.159(c). Likewise, as specified at § 423.160(a)(2), prescribers and
dispensers that conduct electronic transactions for covered Part D drugs for Part D eligible
individuals for which a program standard has been adopted must do so using the adopted
standard. Transaction standards are periodically updated to take new knowledge, technology, and
other considerations into account. As CMS adopted specific versions of the standards when it
initially adopted the foundation and final e-prescribing standards, there was a need to establish a
process by which the standards could be updated or replaced over time to ensure that the
standards did not hold back progress in the health care industry. CMS discussed these processes
in the final rule titled “Medicare Program; E-Prescribing and the Prescription Drug Program,”
(hereinafter referred to as “the November 2005 final rule”) which appeared in the November 7,
2005 Federal Register (70 FR 67579). An account of successive adoption of new and retirement
of previous versions of various e-prescribing standards is described in the final rule titled
“Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical
Laboratory Fee Schedule & Other Revisions to Part B for CY 2014,” which appeared in the
December 10, 2013 Federal Register (78 FR 74229); the proposed rule titled “Medicare
Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage,
Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit
Programs, and the PACE Program,” which appeared in the November 28, 2017 Federal
Register (82 FR 56336); and the corresponding final rule (83 FR 16440), which appeared in the

April 16, 2018 Federal Register. The final rule titled “Medicare Program; Secure Electronic
Prior Authorization For Medicare Part D,” which appeared in the December 31, 2020 Federal
Register (85 FR 86824), codified the requirement that Part D sponsors support the use of
NCPDP SCRIPT standard version 2017071 for certain ePA transactions (85 FR 86832).
The final rule titled “Modernizing Part D and Medicare Advantage To Lower Drug Prices
and Reduce Out-of-Pocket Expenses,” (herein after referred to as “the May 2019 final rule”)
which appeared in the May 23, 2019 Federal Register (84 FR 23832), codified at
§ 423.160(b)(7) the requirement that Part D sponsors adopt an electronic RTBT capable of
integrating with at least one prescriber’s electronic prescribing or electronic health record (EHR)
system, but did not name a standard since no standard had been identified as the industry
standard at the time (84 FR 23851). The electronic standards for eligibility transactions were
codified in the final rule titled “Medicare and Medicaid Program; Regulatory Provisions to
Promote Program Efficiency, Transparency, and Burden Reduction,” which appeared in the May
16, 2012 Federal Register (77 FR 29001), to align with the applicable HIPAA transaction
standards.
The Part D program has historically adopted electronic prescribing standards
independently of other HHS components that may adopt electronic prescribing standards under
separate authorities; however, past experience has demonstrated that duplicative adoption of
health IT standards by other agencies within HHS under separate authorities can create
significant burden on the health care industry as well as HHS when those standards impact the
same technology systems. Notably, independent adoption of the NCPDP SCRIPT standard
version 2017071 by CMS in various subsections of § 423.160 (83 FR 16638) in 2018, which
required use of the standard beginning in 2020, led to a period where ONC had to exercise
special enforcement discretion in its Health Information Technology (IT) Certification Program
until the same version was incorporated into regulation at 45 CFR 170.205(b)(1) through the
final rule titled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC

Health IT Certification Program,” (hereinafter referred to as the “ONC Cures Act final rule”),
which appeared in the May 1, 2020 Federal Register (85 FR 25679). This resulted in significant
impact on both ONC and CMS program resources. Similarly, the final rule titled “Medicare and
Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and
Burden Reduction,” which appeared in the May 16, 2012 Federal Register (77 FR 29002),
noted that, in instances in which an e-prescribing standard has also been adopted as a HIPAA
transaction standard in 45 CFR part 162, the process for updating the e-prescribing standard will
have to be coordinated with the maintenance and modification of the applicable HIPAA
transaction standard (77 FR 29018).
3. Withdrawal of Previous Proposals and Summary of New Proposals
In the proposed rule titled, “Medicare Program; Contract Year 2024 Policy and
Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit
Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions
of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health
Information Technology Standards and Implementation Specifications” (hereinafter referred to
as “the December 2022 proposed rule”), which appeared in the Federal Register on December
27, 2022 (87 FR 79452), we proposed updates to the electronic prescribing standards to be used
by Part D sponsors, prescribers, and dispensers when electronically transmitting prescriptions
and prescription-related information for covered Part D drugs for Part D eligible individuals .
The proposals in the December 2022 proposed rule included a novel approach to updating
electronic prescribing standards by proposing to cross-reference Part D requirements with
standards adopted by the Office of the National Coordinator for Health Information Technology
(ONC) and the standards adopted by HHS for electronic transactions under HIPAA,1 rather than
the historical approach of adopting electronic prescribing standards in the Part D regulations

HIPAA mandated the adoption of standards for electronically conducting certain health care administrative
transactions between certain entities. HIPAA administrative requirements are codified at 45 CFR part 162. See also:
https://www.cms.gov/about-cms/what-we-do/administrative-simplification.
independently or making conforming amendments to the Part D regulations in response to
updated HIPAA standards for eligibility transactions. We proposed this approach in concert with
ONC in order to mitigate potential compliance challenges for the health care industry and
enforcement challenges for HHS that could result from independent adoption of such standards.2
As discussed in the November 2023 proposed rule, we withdrew all proposals contained
in section III.S. Standards for Electronic Prescribing (87 FR 79548) of the December 2022
proposed rule (88 FR 78488). This approach allowed us to incorporate the feedback we received
on prior proposals, seek comment on concerns raised in response to prior proposals, add new
proposals, reorganize and propose technical changes to the electronic prescribing regulations at
§ 423.160, and allow the public to comment on all Medicare Part D electronic prescribing-related
proposals simultaneously.
In sections II.A.4. through II.A.11. of this rule, we discuss the proposals related to
standards for electronic prescribing that we put forth in the November 2023 proposed rule, which
encompassed all of the following:
● Requiring use of NCPDP SCRIPT standard version 2023011, proposed for adoption for
HHS use at 45 CFR 170.205(b)(2), and retiring use of NCPDP SCRIPT standard version
2017071 for communication of a prescription or prescription-related information supported by
Part D sponsors beginning January 1, 2027. This proposal included a transition period beginning
on the effective date of the final rule during which either version of the NCPDP SCRIPT
standard could be used. Under this proposal, the transition period would end on January 1, 2027,
which is the date that ONC proposed at 45 CFR 170.205(b)(1) that NCPDP SCRIPT standard
version 2017071 would expire for the purposes of HHS use, as described in section II.B.8.a. of
this rule.

Due to discrepancies between prior regulatory timelines, adoption of the NCPDP SCRIPT standard version
2017071 in different rules led to a period where ONC had to exercise special enforcement discretion in the ONC
Health IT Certification Program. For additional discussion, see section II.B.5. of this final rule.
● Requiring use of NCPDP RTPB standard version 13, proposed for adoption for HHS
use at 45 CFR 170.205(c)(1), for prescriber RTBTs implemented by Part D sponsors beginning
January 1, 2027.
● Requiring use of NCPDP Formulary and Benefit (F&B) standard version 60, proposed
for adoption at 45 CFR 170.205(u)(1), and retiring use of NCPDP F&B standard version 3.0 for
transmitting formulary and benefit information between prescribers and Part D sponsors
beginning January 1, 2027. This proposal included a transition period beginning on the effective
date of the final rule and ending January 1, 2027, during which entities would be permitted to use
either NCPDP F&B standard version 3.0 (currently adopted in regulation at § 423.160(b)(5)(iii)
and proposed to be moved to § 423.160(b)(3) consistent with the proposed technical changes
discussed in section II.A.10 of this rule) or NCPDP F&B standard version 60, proposed for
adoption for HHS use at 45 CFR 170.205(u)(1).
● Cross-referencing standards adopted for eligibility transactions in HIPAA regulations
at 45 CFR 162.1202 for requirements related to eligibility inquiries.
● Making multiple technical changes to the regulation text throughout § 423.160 by
removing requirements and incorporations by reference that are no longer applicable, reorganizing existing requirements, and correcting a technical error.
We proposed a novel approach to updating e-prescribing standards by cross-referencing
Part D e-prescribing requirements with standards, including any expiration dates, adopted by
ONC, as discussed in section II.B.5. of this rule, and the standards adopted by HHS for
electronic transactions under HIPAA. This approach differed from our historical approach of
adopting e-prescribing standards in the Part D regulations independently or undertaking
rulemaking to make conforming amendments to the Part D regulations in response to updated
HIPAA standards for eligibility transactions.3 As ONC notes in section II.B.5. of this rule,

HIPAA eligibility transaction standards were updated in final rule titled “Health Insurance Reform; Modifications
to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards,” which
independent adoption of the NCPDP SCRIPT standard version 2017071 in different rules4 led to
a period where ONC had to exercise special enforcement discretion in the ONC Health IT
Certification Program. We believe the proposed approach mitigates potential compliance
challenges for the health care industry and enforcement challenges for HHS that could result
from independent adoption of such standards or asynchronous rulemaking cycles across
programs. CMS invited comment on all aspects of these proposals. We also proposed to crossreference ONC regulations adopting NCPDP SCRIPT standard version 2023011, NCPDP RTPB
standard version 13, and NCPDP F&B standard version 60. We solicited comment on the effect
of the proposals that, taken together, would require use of these standards by January 1, 2027 as
a result of ONC’s proposals to adopt these standards and retire previous versions, as well as our
proposal to require use of NCPDP F&B standard version 60 by that date.
The NCPDP SCRIPT standards are used to exchange information among prescribers,
dispensers, intermediaries, and Medicare prescription drug plans (PDPs). NCPDP requested that
CMS adopt NCPDP SCRIPT standard version 2023011 because this version provides a number
of enhancements to support electronic prescribing and transmission of prescription-related
information.5 Accordingly, we proposed to update § 423.160 to specify where transactions for
electronic prescribing, medication history, and ePA are required to utilize the NCPDP SCRIPT
standard. As described in section II.A.7. of this final rule, we solicited comment on the date by
which use of the updated version of this and other standards in this rule would be required.

appeared in the January 16, 2009 Federal Register (74 FR 3296). Conforming amendments to the Part D regulation
were made in the final rule titled “Medicare and Medicaid Program; Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction,” which appeared in the May 16, 2012 Federal Register (77 FR
29002).
4 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
final rule, which appeared in the May 1, 2020 Federal Register (85 FR 25642), and the Medicare Program;
Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Feefor-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program final rule, which appeared in
the April 16, 2018 Federal Register (83 FR 16440).
5 National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version
2023011. NCPDP SCRIPT standard implementation guides are available to NCPDP members for free and to nonmembers for a fee at https://standards.ncpdp.org/Access-to-Standards.aspx. The NCPDP SCRIPT standard version
2023011 implementation guide proposed for incorporation by reference in sections II.A.11 and II.B.10. of this rule
can be viewed by interested parties for free by following the instructions provided in those sections.

The NCPDP RTPB standard enables the real-time exchange of patient-specific eligibility,
product coverage (including any restrictions and alternatives), and estimated cost sharing so
prescribers have access to this information through a RTBT application at the point-ofprescribing.6,7 As discussed in section II.A.5. of this rule, as currently codified at
§ 423.160(b)(7), CMS requires that Part D sponsors implement one or more electronic RTBTs
that are capable of integrating with at least one prescriber’s electronic prescribing system or
electronic health record, as of January 1, 2021; however, at the time CMS established this
requirement, no single industry standard for real-time prescription benefit applications was
available. NCPDP has since developed the NCPDP RTPB standard. We proposed to require the
most current version, NCPDP RTPB standard version 13, as the standard for prescriber RTBTs
at § 423.160(b)(5) starting January 1, 2027.
The NCPDP F&B standard is a batch standard that provides formulary and benefit
information at the plan level rather than at the patient level. The NCPDP F&B standard
complements other standards utilized for electronic prescribing, electronic prior authorization,
and real-time prescription benefit applications.8,9 We proposed to require use of NCPDP F&B
standard version 60, and retire NCPDP F&B standard version 3.0, beginning January 1, 2027,
after a transition period during which either version may be used.
Eligibility inquiries utilize the NCPDP Telecommunication standard or Accredited
Standards Committee X12N 270/271 inquiry and response transaction for pharmacy or other

National Council for Prescription Drug Programs (NCPDP) Real-Time Prescription Benefit Standard,
Implementation Guide, Version 13. NCPDP RTPB standard implementation guides are available to NCPDP
members for free and to non-members for a fee at https://standards.ncpdp.org/Access-to-Standards.aspx The
NCPDP RTPB standard version 13 implementation guide incorporated by reference in sections II.A.11. and II.B.10.
of this rule can be viewed by interested parties for free by following the instructions provided in those sections.
7 Bhardwaj S, Miller SD, Bertram A, Smith K, Merrey J, Davison A. Implementation and cost validation of a realtime benefit tool. Am J Manag Care. 2022 Oct 1;28(10):e363-e369. doi: 10.37765/ajmc.2022.89254.
8 National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit Standard, Implementation
Guide, Version 60. NCPDP F&B standard implementation guides are available to NCPDP members for free and to
non-members for a fee at https://standards.ncpdp.org/Access-to-Standards.aspx. The NCPDP F&B standard version
60 implementation guide incorporated by reference in sections II.A.11 and II.B.10. of this rule can be viewed by
interested parties for free by following the instructions provided in those sections.
9 Babbrah P, Solomon MR, Stember L, Hill JW, Weiker M. Formulary & Benefit and Real-Time Pharmacy Benefit:
Electronic standards delivering value to prescribers and pharmacists. J Am Pharm Assoc. 2023 May-June;63(3):725730. https://doi.org/10.1016/j.japh.2023.01.016.
health benefits, respectively. The Part D program has adopted standards based on the HIPAA
electronic transaction standards, which have not been updated for more than a decade. HHS has
proposed updates to the HIPAA electronic transaction standards for retail pharmacies (87 FR
67638) in the proposed rule titled “Administrative Simplification: Modifications of Health
Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription
Drug Programs (NCPDP) Retail Pharmacy Standards; and Adoption of Pharmacy Subrogation
Standard” (hereinafter referred to as the “November 2022 Administrative Simplification
proposed rule”), which appeared in the November 9, 2022 Federal Register (87 FR 67634).
In the November 2023 proposed rule, we proposed to update the Part D regulation at
§ 423.160(b)(3) to require that eligibility transactions utilize the applicable standard named as
the HIPAA standard for electronic eligibility transactions at 45 CFR 162.1202. Since
45 CFR 162.1202 currently identifies the same standards that are named at § 423.160(b)(3)(i)
and (ii), we anticipated there would be no immediate impact from this proposed change in
regulatory language. We proposed this change to ensure that Part D electronic prescribing
requirements for eligibility transactions align with the HIPAA standard for electronic eligibility
transactions, should a newer version of the NCPDP Telecommunication (or other) standards be
adopted as the HIPAA standard for these types of electronic transactions, if HHS’ proposals in
the November 2022 Administrative Simplification proposed rule are finalized or as a result of
any future HHS rules.
4. Requiring NCPDP SCRIPT Standard Version 2023011 as the Part D Electronic Prescribing
Standard, Retirement of NCPDP SCRIPT Standard Version 2017071, and Related Conforming
Changes in § 423.160
The NCPDP SCRIPT standard has been the adopted electronic prescribing standard for
transmitting prescriptions and prescription-related information using electronic media for
covered Part D drugs for Part D eligible individuals since foundation standards were named in
the final rule titled “Medicare Program; E-Prescribing and the Prescription Drug Program,”

which appeared in the November 7, 2005 Federal Register (70 FR 67568), at the start of the
Part D program. The NCPDP SCRIPT standard is used to exchange information among
prescribers, dispensers, intermediaries, and Medicare prescription drug plans. In addition to
electronic prescribing, the NCPDP SCRIPT standard is used in electronic prior authorization
(ePA) and medication history transactions.
Although electronic prescribing is optional for physicians, except as to Schedule II, III,
IV, and V controlled substances that are Part D drugs prescribed under Part D, and pharmacies,
the Medicare Part D statute and regulations require drug plans participating in the prescription
benefit to support electronic prescribing, and physicians and pharmacies who elect to transmit
prescriptions and related communications electronically must utilize the adopted standards
except in limited circumstances, as codified at § 423.160(a)(3).
NCPDP’s standards development process involves a consensus-based approach to solve
emerging needs of the pharmacy industry or to adapt NCPDP standards to changes made by
other standards development organizations.10 Emerging needs of the pharmacy industry may be
the result of legislative or regulatory changes, health IT innovations, patient safety issues, claims
processing issues, or electronic prescribing-related process automation.11 Changes to standards
are consensus-based and driven by the NCPDP membership, which includes broad representation
from pharmacies, insurers, pharmacy benefit managers, Federal and State government agencies,
and vendors serving all the stakeholders.12,13
In a letter to CMS dated January 14, 2022, NCPDP requested that CMS adopt NCPDP
SCRIPT standard version 2022011, given the number of updates and enhancements that had
been added to the standard since NCPDP SCRIPT standard version 2017071 was adopted.14

https://standards.ncpdp.org/Our-Process.aspx
NCPDP University. How Industry Needs Drive Changes in Standards. Accessed August 15, 2023, from
https://member.ncpdp.org (member-only content).
12 NCPDP University. Voting: The Life Cycle of Standards Approval. Accessed August 15, 2023, from
https://member.ncpdp.org (member-only content).
13 https://www.ncpdp.org/Membership-diversity.aspx
14 https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDPSCRIPTNextVersionLetter.pdf
10
NCPDP summarized the major enhancements in NCPDP SCRIPT standard version 2022011
relative to the currently required NCPDP SCRIPT standard version 2017071. Those summarized
enhancements include-● General extensibility;15
● Redesign of the Product/Drug groupings requiring National Drug Code (NDC) for
DrugCoded element, but not for NonDrugCoded element;
● Addition of Observation elements to Risk Evaluation and Mitigation Strategies
(REMS) transactions;
● Addition of ProhibitRenewalRequest to RxChangeResponse and RxRenewalResponse;
● Modification of Structured and Codified Sig Structure format; and
● Additional support related to dental procedure codes, RxBarCode, PatientConditions,
patient gender and pronouns, TherapeuticSubstitutionIndicator, multi-party communications, and
withdrawal/retracting of a previously sent message using the MessageIndicatorFlag.
Subsequently, in the December 2022 proposed rule, CMS proposed to require NCPDP
SCRIPT standard version 2022011 and retire NCPDP SCRIPT standard version 2017071, after a
transition period, by cross-referencing the standards as proposed for adoption by ONC. In
response to this proposal, NCPDP and many other commenters recommended that CMS instead
adopt the more current NCPDP SCRIPT standard version 2023011. NCPDP SCRIPT standard
version 2023011, like NCPDP SCRIPT standard version 2022011, includes the functionality that
supports a 3-way transaction (for example, multi-party communication) among prescriber,
facility, and pharmacy, which will enable EPCS in the long-term care (LTC) setting.16 In its

Extensibility is a term in software engineering that is defined as the quality of being designed to allow the addition
of new capabilities or functionality. See: Ashaolu B. What is Extensibility? Converged. February 17, 2021.
Available from: https://converged.propelsoftware.com/blogs/what-is-extensibility.
16 National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version
2023011. NCPDP SCRIPT standard implementation guides are available to NCPDP members for free and to nonmembers for a fee at https://standards.ncpdp.org/Access-to-Standards.aspx. The NCPDP SCRIPT standard version
2023011 implementation guide incorporated by reference in sections II.A.11 and II.B.10. of this rule can be viewed
by interested parties for free by following the instructions provided in those sections.
comments on the December 2022 proposed rule,17 NCPDP highlighted specific enhancements
within NCPDP SCRIPT standard version 2023011 that are not present in NCPDP SCRIPT
standard version 2022011, which include—
● Addition of an optional element in the header for OtherReferenceNumber for multiparty communication transactions, such as those in LTC;
● Addition of a response type of Pending for RxChangeResponse and
RxRenewalResponse for communicating when to expect an approval or denial of the request or
delays in approval or denial of requests;
● Addition of a new RequestExpirationDate element to NewRxRequest,
RxChangeRequest, and RxRenewalRequest to notify the prescriber to not send a response after
this date;
● Addition of a new element NoneChoiceID to PASelectType so that a “none of the
above” answer can be selected by the provider and allow branching to the next question in a
series;
● Addition of a new element for REMSReproductivePotential replacing
REMSPatientRiskCategory in the prescribed medication element group in the NewRx and
RxChangeRequest message and in the replace medication element group for the
RxRenewalResponse;
● Addition of a new element group of ReviewingProvider to the Resupply and
Recertification messages to allow for the reporting of the provider who reviewed the chart and
certified continued need of a specific medication; and
● Revised guidance in the SCRIPT Implementation Guide.

17https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPR

M.pdf

NCPDP has also published frequently asked questions18 related to the use of NCPDP
SCRIPT standards for electronic transfer of controlled substance prescriptions between
pharmacies, as permitted by the Drug Enforcement Administration (DEA) final rule “Transfer of
Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for
Initial Filling,” (hereinafter referred to as “the July 2023 DEA final rule”) which appeared in the
Federal Register on July 27, 2023 (88 FR 48365). The July 2023 DEA final rule permits the
transfer of electronic prescriptions for schedule II-V controlled substances between retail
pharmacies for initial filling, upon request of the patient, on a one-time basis, in accordance with
requirements codified at 21 CFR 1306.08(e) through (i) and subject to State or other applicable
law. NCPDP SCRIPT standard version 2017071 does not support the transfer of electronic
controlled substance prescriptions; however, NCPDP SCRIPT standard version 2022011 and
later, including NCPDP SCRIPT standard version 2023011, allow for the transfer of electronic
controlled substance prescriptions since these later versions contain data elements required to
document the transfer between pharmacies. NCPDP SCRIPT standard versions 2022011 and
later also contain additional RxTransfer transaction features that facilitate the transfer of
electronic prescriptions for controlled substances by pharmacies by allowing pharmacies to
initiate transfers of prescriptions to other pharmacies (that is, “push” transactions) in addition to
the functionality that currently exists in the NCPDP SCRIPT standard version 2017071 that
allows pharmacies to request transfers from other pharmacies (that is, “pull” transactions).
NCPDP SCRIPT standard version 2023011 is fully backwards compatible with NCPDP
SCRIPT standard version 2017071. This allows for a less burdensome implementation process
and flexible adoption timeline for pharmacies, payers, prescribers, health IT vendors, and
intermediaries involved in electronic prescribing, since backwards compatibility permits a

Frequently Asked Questions 5.1.11 and 5.1.12. SCRIPT Implementation Recommendations. March 2024.
Available from https://ncpdp.org/NCPDP/media/pdf/SCRIPT-Implementation-Recommendations.pdf.
transition period where both versions of the NCPDP SCRIPT standards may be used
simultaneously without the need for entities involved to utilize a translator program.
Even though we withdrew the proposals contained in section III.S. (Standards for
Electronic Prescribing) in the December 2022 proposed rule (87 FR 79548), we considered
comments we received on the December 2022 proposed rule when crafting the proposals
discussed in this rule. For instance, several commenters requested that CMS clearly indicate that
the proposed version of the NCPDP SCRIPT standard would apply to medication history
functions. Several commenters noted that the regulation text at § 423.160(b)(4)(ii) does not list
the NCPDP SCRIPT standard-specific medication history transactions. Commenters requested
that CMS list the corresponding medication history transactions (RxHistoryRequest and
RxHistoryResponse) in the regulation text in order to minimize ambiguity. After considering
these comments, in the November 2023 proposed rule, we proposed to list the RxHistoryRequest
and RxHistoryResponse transactions at § 423.160(b)(1)(i)(U) subsequent to our technical
reorganization of the section discussed in section II.A.10. of this rule, rather than list the
transactions under § 423.160(b)(4).
With respect to ePA transactions in the NCPDP SCRIPT standard currently listed at
§ 423.160(b)(8)(i)(A) through (D) (PAInitiationRequest, PAInitiationResponse, PARequest,
PAResponse, PAAppealRequest, PAAppealResponse, PACancelRequest, PACancelResponse)
and a new ePA transaction (PANotification) available in NCPDP SCRIPT standard version
2023011, we proposed to list all transactions at § 423.160(b)(1)(i)(V)-(Z). We proposed new
language at § 423.160(b)(1) to indicate that the transactions listed must comply with a standard
in proposed 45 CFR 170.205(b) “as applicable to the version of the standard in use,” since an
older version of a standard may not support the same transactions as the newer version of the
standard. For example, during the proposed transition period where either NCPDP SCRIPT
standard version 2017071 or NCPDP SCRIPT standard version 2023011 may be used, entities
that are still using NCPDP SCRIPT standard version 2017071 would not be expected to use the

PANotification transaction because the PANotification transaction is only supported in the
NCPDP SCRIPT standard version 2023011.
Since the NCPDP SCRIPT standard version 2023011 is fully backwards compatible with
NCPDP SCRIPT standard version 2017071, the pharmacies, payers, prescribers, health IT
vendors, and intermediaries involved in electronic prescribing can accommodate a transition
period when either version may be used. That is, during a transition period, transactions taking
place between entities using different versions of the same standard maintain interoperability
without the need for entities to utilize (that is, purchase) a translator software program. The
cross-reference to proposed 45 CFR 170.205(b) permits a transition period starting as of the
effective date of a final rule during which either NCPDP SCRIPT standard version 2017071 or
NCPDP SCRIPT standard version 2023011 may be used.
Instead of proposing to independently adopt NCPDP SCRIPT standard version 2023011,
we proposed at § 423.160(b)(1) to cross-reference a standard in 45 CFR 170.205(b). ONC
proposed to adopt NCPDP SCRIPT standard version 2023011 in 45 CFR 170.205(b)(2) as
described in section III.C.8.a. of the November 2023 proposed rule. This approach enables CMS
and ONC to avoid misalignment from independent adoption of NCPDP SCRIPT standard
version 2023011 for their respective programs. Updates to the standard would impact
requirements for both programs at the same time, ensure consistency, and promote alignment for
providers, payers, and health IT developers participating in and supporting the same prescription
transactions. See section II.B.5. of this rule for additional discussion of this coordination effort.
In its letter to CMS requesting CMS adopt NCPDP SCRIPT standard version 2022011,
NCPDP requested that CMS identify certain transactions for prescriptions for which use of the
standard is mandatory.19 As previously mentioned in this preamble, in response to the December
2022 proposed rule, NCPDP and other commenters requested additional transactions be named

https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDPSCRIPTNextVersionLetter.pdf

in regulation. As part of our proposed reorganization of § 423.160, we proposed to list all
transactions associated with the NCPDP SCRIPT standard requirements in one place in the
regulation. We proposed the transactions for prescriptions, ePA, and medication history for
which use of the standard is mandatory at § 423.160(b)(1)(i)(A) through (Z), as described in
Table 1.
TABLE 1: PROPOSED TRANSACTIONS FOR COMMUNICATION OF
PRESCRIPTION AND PRESCRIPTION RELATED INFORMATION USING THE
NCPDP SCRIPT STANDARD
Transaction
GetMessage

Status
Error
RxChangeRequest and
RxChangeResponse

RxRenewalRequest and
RxRenewalResponse
Resupply
Verify
CancelRx and CancelRxResponse
RxFill

Function Supported by Transaction20
Requests from a mailbox, a renewal prescription request,
prescription change request, new prescription request,
prescription fill status notification, verification, transfer
request, transfer response, transfer confirmation or an error or
other transactions that have been sent by a pharmacy or
prescriber system.
Relays acceptance of a transaction back to the sender.
Indicates an error has occurred indicating the request was
terminated.
Request from a pharmacy to a prescriber asking for a change in a
new or “fillable” prescription; additional usage includes
verification of prescriber credentials and request on a prior
authorization from the payer. Response is sent from a prescriber
to the requesting pharmacy to either approve, approve with
change, validate, or deny the request.
Request from the pharmacy to the prescriber requesting
additional refills. Response is sent from the prescriber to the
requesting pharmacy to allow pharmacist to provide a patient
with additional refills, a new prescription, or decline to do either.
Request from a Long Term or Post-Acute Care (LTPAC)
organization to a pharmacy to send an additional supply of
medication for an existing order.
Response to a pharmacy or prescriber indicating that a
transaction requesting a return receipt has been received.
Request from the prescriber to the pharmacy to inactivate a
previously sent prescription. Response is sent from the pharmacy
to the prescriber to acknowledge a cancel request.
Indicates the dispensing or activity status. It is the notification
from one entity to another conveying the status of dispensing
activities or other clinical activities.

Section 4. Business Functions, and Section 5. Transactions. National Council for Prescription Drug Programs
(NCPDP) SCRIPT Standard, Implementation Guide, Version 2023011. NCPDP SCRIPT standard implementation
guides are available to NCPDP members for free and to non-members for a fee at
https://standards.ncpdp.org/Access-to-Standards.aspx. The NCPDP SCRIPT standard version 2023011
implementation guide incorporated by reference in sections II.A.11 and II.B.10. of this rule can be viewed by
interested parties for free by following the instructions provided in those sections.
Transaction
DrugAdministration

NewRxRequest
NewRx
NewRxResponseDenied
RxTransferInitiationRequest
(previously named
RxTransferRequest in NCPDP
SCRIPT standard version 2017071)
RxTransfer (previously named
RxTransferResponse NCPDP
SCRIPT standard version 2017071)

RxTransferConfirm
RxFillIndicatorChange

Recertification
REMSInitiationRequest and
REMSInitiationResponse

REMSRequest and REMSResponse

RxHistoryRequest and
RxHistoryResponse

PAInitiationRequest and
PAInitiationResponse

Function Supported by Transaction20
Communicates drug administration events from a prescriber/care
facility to the pharmacy or other entity. It is a notification from a
prescriber/care facility to a pharmacy or other entity that a drug
administration event has occurred.
Request from a pharmacy to a prescriber for a new prescription
for a patient. If approved, a NewRx transaction will be sent.
New prescription is sent from the prescriber to the pharmacy
electronically so it can be dispensed to a patient.
Denied response to a previously sent NewRxRequest.
Used when the destination pharmacy is asking for a transfer of
one or more prescriptions for a specific patient from the source
pharmacy.
In the solicited model, it is the response to the
RxTransferInitiationRequest which includes the prescription(s)
being transferred from the source pharmacy to the destination
pharmacy or a rejection of the transfer request. In the unsolicited
model, it is a push of the prescription(s) being transferred from
the source pharmacy to the destination pharmacy.
Used by the destination pharmacy to confirm the transfer
prescription has been received and the transfer is complete.
Sent to the receiver to indicate the sender is changing the types
of RxFill responses that were previously requested. The sender
may modify the fill status notification of transactions previously
selected or cancel future RxFill transactions.
Notification on behalf of a reviewing provider to a pharmacy
recertifying the continued administration of a medication order.
Used in LTPAC only.
Request to the REMS Administrator for the information required
to submit a REMS request (REMSRequest) for a specified
patient and drug. Response is from the REMS Administrator
with the information required to submit a REMS request
(REMSRequest) for a specified patient and drug.
Request to the REMS Administrator with information (answers
to question set; clinical documents) to make a REMS
determination (approved, denied, pended, etc.). Response is the
determination from the REMS administrator whether dispensing
authorization can be granted.
Request from one entity to another for a list of medications that
have been prescribed, dispensed, claimed or indicated by the
patient. Response includes the medications that were dispensed
or obtained within a certain timeframe, optionally including the
prescriber that prescribed them.
Request from the submitter to a payer for the information
required to submit a prior authorization request (PARequest) for
a specified patient and product. Response is from a payer to the
submitter with the information required to submit a prior
authorization request (PARequest) for a specified patient and
product.

Transaction
PARequest and
PAResponse

PAAppealRequest and
PAAppealResponse;
PACancelRequest and
PACancelResponse
PANotification

Function Supported by Transaction20
Request from the submitter to the payer with information
(answers to question set; clinical documents) for the payer to
make a PA determination (approved, denied, pended, etc.).
Response from the payer to the submitter indicates the status of a
PARequest. Response could be a PA determination, notice that
the request is in process, or specify that more information is
required.
Request from the submitter to the payer to appeal a PA
determination. Response from the payer to the submitter
indicates what information is needed for an appeal or the status
or outcome of a PAAppealRequest.
Request from the submitter to the payer to notify the payer that
the PA request is no longer needed. Response from the payer to
the submitter indicates if the PA request was cancelled or not.
Alerts the pharmacist or prescriber when a PA has been
requested, or when a PA determination has been received.

The transactions specific to electronic prescribing remain the same as those required for
NCPDP SCRIPT standard version 2017071 (currently codified at § 423.160(b)(2)(iv)(A) through
(Z)), except where renamed as noted in Table 1. The transactions specific to ePA are also the
same as those required with NCPDP SCRIPT standard version 2017071 (with one additional
transaction—PA Notification), which was incorporated into the standard after NCPDP SCRIPT
standard version 2017071. As discussed in section II.B.8.a. of this rule, NCPDP SCRIPT
standard version 2023011 was proposed for adoption at 45 CFR 170.205(b)(2), and NCPDP
SCRIPT standard version 2017071 was proposed to expire January 1, 2027 at
45 CFR 170.205(b)(1).
As stated previously, in response to the December 2022 proposed rule, several
commenters pointed out that if mandatory use of an updated version of the NCPDP SCRIPT
standard is delayed, then the EPCS requirement in LTC facilities should also be delayed
accordingly, since NCPDP SCRIPT standard version 2017071 lacks appropriate guidance for
LTC facilities. CMS was aware of this limitation in the NCPDP SCRIPT standard version
2017071, and acknowledged the challenges to EPCS faced by LTC facilities in the proposed rule
“Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other

Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider
Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical
Review Requirements” (hereinafter referred to as “the July 2022 proposed rule”), which
appeared in the Federal Register on July 23, 2021 (86 FR 39104). However, in the July 2022
proposed rule, CMS also stated that we understood that NCPDP was in the process of creating
specific guidance for LTC facilities within the NCPDP SCRIPT standard version 2017071,
which would allow willing partners to enable 3-way communication between the prescriber,
LTC facility, and pharmacy to bridge any outstanding gaps that impede adoption of the NCPDP
SCRIPT standard version 2017071 in the LTC setting (86 FR 39329).
Similarly, in the “Medicare Program; CY 2022 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program
Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment
and Post-Payment Medical Review Requirements” final rule (hereinafter referred to as “the
November 2021 final rule”), which appeared in the Federal Register on November 19, 2021 (86
FR 64996), CMS acknowledged that although 3-way communication is not as seamless in
NCPDP SCRIPT standard version 2017071 as it was expected to be in later versions, EPCS was
still possible with some modifications (86 FR 65364). CMS delayed EPCS compliance for
prescribers’ prescriptions written for beneficiaries in a LTC facility from January 1, 2022 to no
earlier than January 1, 2025, in order to give prescribers additional time to make the necessary
changes to conduct electronic prescribing of covered Part D controlled substance prescriptions
for Part D beneficiaries in LTC facilities using NCPDP SCRIPT standard version 2017071 (86
FR 65365). We did not propose a change in the EPCS compliance date for covered Part D
controlled substance prescriptions for Part D beneficiaries in LTC on the basis of the proposed
adoption of NCPDP SCRIPT standard version 2023011; however, we invited comment on the
status of EPCS in LTC and the degree to which LTC facilities have been able to implement
guidance from NCPDP to meet the EPCS requirement.

As proposed, § 423.160(b)(1) would require use of a version of the NCPDP SCRIPT
standard adopted in 45 CFR 170.205(b) to carry out the transactions listed in
§ 423.160(b)(1)(i)(A) through (Z). However, it would not require that all transactions be utilized
if they are not needed or are not relevant to the entity. We refer readers to ONC’s Interoperability
Standards Advisory (ISA) website for descriptions and adoption level of transactions in the
NCPDP SCRIPT standard.21 For example, we have been informed that the “GetMessage”
transaction described in Table 1 is not widely used among prescribers. For this reason, we are
reiterating guidance22 that the NCPDP SCRIPT standard transactions named are not themselves
mandatory, but rather they are to be used as applicable to the entities specified at
§§ 423.160(a)(1) and (2) when they are completing or supporting the transmission of information
related to electronic prescriptions, electronic prior authorization, or medication history. We
believe the pharmacies, payers, prescribers, health IT vendors, and intermediaries involved in
electronic prescribing have been utilizing the standards in this manner, based on discussions with
NCPDP. We would also like to use this opportunity to note that where entities are permitted to
use more than one version of the NCPDP SCRIPT standard because more than one version of the
NCPDP SCRIPT standard is adopted in 45 CFR 170.205(b), to the extent practicable, entities
can utilize transactions available in different versions of the standard simultaneously. For
example, as of the effective date of this final rule, entities would be permitted to use the NCPDP
SCRIPT standard version 2023011 for RxTransferInitiationRequest, RxTransfer, and
RxTransferConfirm transactions, but could continue to use NCPDP SCRIPT standard version
2017071 for other transactions until NCPDP SCRIPT standard version 2017071 expires for HHS
use on January 1, 2028. This would enable entities to expedite implementing the functionality
necessary for the transfer of electronic controlled substance prescriptions consistent with DEA

https://www.healthit.gov/isa/section/pharmacyinteroperability
Supporting Electronic Prescribing Under Medicare Part D. September 19, 2008.
https://www.hhs.gov/guidance/document/supporting-electronic-prescribing-under-medicare-part-d.
21
requirements, as previously described, while implementing other updates associated with
NCPDP SCRIPT standard version 2023011 at a later time.
In summary, with respect to changes related to requiring, via cross-reference to ONC
regulations (as discussed in section II.B.8.a. of this final rule), NCPDP SCRIPT standard version
2023011 and retiring NCPDP SCRIPT standard version 2017071, we proposed a revised
paragraph § 423.160(b)(1) that would—
● Consolidate all transactions for electronic prescribing, ePA, and medication history for
which use of the NCPDP SCRIPT standard is mandatory at § 423.160(b)(1)(i)(A)-(Z); and
● Indicate that communication of prescriptions and prescription-related transactions
listed must comply with a standard in 45 CFR 170.205(b). In conjunction with ONC proposals
(discussed in section II.B.8.a. of this rule), this cross-reference would permit a transition period
when either NCPDP SCRIPT standard versions 2017071 or 2023011 may be used beginning as
of the effective date of a final rule and ending January 1, 2027, because, as ONC proposed at
45 CFR 170.205(b)(1), the NCPDP SCRIPT standard version 2017071 would expire
January 1, 2027, after which only NCPDP SCRIPT standard version 2023011 would be available
for HHS use.
We solicited comment on these proposals. A discussion of the comments received, along
with our responses, follows.
Comment: All commenters supported the proposal to update NCPDP SCRIPT standard
version 2017071 to NCPDP SCRIPT standard version 202311 for the electronic transmission of
prescriptions and prescription-related information, including medication history and ePA.
Response: We thank commenters for their support.
Comment: Several commenters expressed concern over the proposed date of January 1,
2027 when use of NCPDP SCRIPT standard version 2023011 would be required.
Response: See section II.A.7. of this rule for discussion of this concern.

Comment: One commenter requested that the exemption from the use of the NCPDP
SCRIPT standard (and when use of HL7 messages are permitted) for the transmission of
prescriptions and prescription-related information internally when the sender and recipient are
part of the same legal entity be extended to the prescription transfer transactions when the sender
and the recipient are not part of the same legal entity. For example, transferring a prescription
between a pharmacy that is part of a health maintenance organization (HMO) and pharmacy that
is not part of the HMO could be done using HL7 messaging rather than the NCPDP SCRIPT
standard version 2023011 RxTransferInitiationRequest, RxTransfer, and RxTransferConfirm
transactions (or NCPDP SCRIPT standard version 2017071 RxTransferRequest,
RxTransferResponse, and RxTransferConfirm transactions).
Response: The commenter did not provide an explanation for why the commenter
requested that we create an exemption from use of the NCPDP SCRIPT standard for prescription
transfer transactions between pharmacies, so CMS attempted to investigate the issue raised by
the commenter. We found evidence that prescription transfer transactions are at a low level of
adoption23 for NCPDP SCRIPT standard version 2017071 despite the fact that CMS has required
the use of NCPDP SCRIPT standard transactions for the transfer of prescriptions for Part D
drugs for Part D eligible individuals between pharmacies since January 1, 2020, when NCPDP
SCRIPT standard version 2017071 was adopted (83 FR 16635-16638). We did not receive any
comments identifying issues with prescription transfer transactions when we proposed the update
to NCPDP SCRIPT standard version 2022011 in the December 2022 proposed rule. NCPDP
SCRIPT standard version 2022011 contained enhancements to prescription transfer transactions
that were not available in NCPDP SCRIPT standard version 2017071,24 and these enhancements
are maintained in NCPDP SCRIPT standard version 2023011. Since we are unable to determine
an underlying reason for the low adoption rate of NCPDP SCRIPT standard version 2017071

https://www.healthit.gov/isa/allows-a-pharmacy-request-respond-or-confirm-a-prescription-transfer
https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDPSCRIPTNextVersionLetter.pdf
23
transactions for prescription transfers between pharmacies, and since we only received one
comment requesting an exemption from use of the NCPDP SCRIPT standard version 2023011
for prescription transfers between pharmacies, we decline to create a new exemption and will
finalize as proposed the requirement to use RxTransferInitiationRequest (previously named
RxTransferRequest), RxTransfer (previously named RxTransferResponse), and
RxTransferConfirm transactions for prescription transfers between pharmacies, when such
transactions take place electronically.
Comment: We received many comments on EPCS in LTC. Many commenters requested
that CMS move the EPCS compliance date for LTC to January 1, 2027 to align with the
proposed date by which NCPDP SCRIPT standard version 2023011 would be required. Some
commenters stated that NCPDP was unable to create guidance to implement EPCS in LTC using
the NCPDP SCRIPT standard version 2017071 because the coding infrastructure did not exist to
support the necessary three-way communication between the prescriber, LTC facility, and
pharmacy. A commenter indicated that they had successfully implemented EPCS in LTC using
NCPDP SCRIPT standard version 2017071 but acknowledged that the enhancements in NCPDP
SCRIPT standard version 2023011 would improve the experience for LTC providers.
Response: We thank commenters for their feedback. As we stated in the November 2023
proposed rule, we did not propose a change to the EPCS compliance date for LTC and therefore
cannot finalize a change in this final rule. Changes to the CMS EPCS program requirements have
been taking place through the annual Medicare Physician Fee Schedule rulemaking process,25
therefore CMS will consider making any changes through that process. In light of the fact that
we are further delaying the required use of NCPDP SCRIPT standard version 2023011 to
January 1, 2028, as discussed in section II.A.7. of this final rule, we will consider the feedback
received for future rulemaking.

See 85 FR 84472, 86 FR 64996, 87 FR 69404, 88 FR 78818

Comment: A commenter suggested embedding the ePA process within the electronic
medical record (EMR).
Response: We thank the commenter for being eager to integrate ePA into their practice;
however, how the NCPDP SCRIPT and other standards are incorporated into EMR/electronic
health record (EHR) design and workflow is outside the scope of this proposal. We refer the
commenter to a Request for Information titled “Electronic Prior Authorization Standards,
Implementation Specifications, and Certification Criteria” (87 FR 3475), which appeared in the
Federal Register on January 24, 2022, and which describes ONC’s approach to considering
updates to the ONC Health IT Certification Program that could support the availability of ePA in
certified health IT for use by health care providers.
After consideration of the public comments we received, we are finalizing our proposal to
require, at § 423.160(b)(1), that communication of a prescription and prescription-related
information must comply with a standard in 45 CFR 170.205(b) for the transactions listed at
§ 423.160(b)(1)(i)(A) through (Z), as applicable to the version of the standard in use. We are also
finalizing our proposals to consolidate required transactions for prescriptions
(§ 423.160(b)(1)(i)(A) through (T)), medication history (§ 423.160(b)(1)(i)(U), and electronic
prior authorization (§ 423.160(b)(1)(i)(V) through (Z)) together since all transactions are specific
to the NCPDP SCRIPT standard versions ONC has previously adopted or is adopting at 45 CFR
170.205(b) as described in section II.B.8.a. of this final rule.
Taken in conjunction with the standards and expiration date adopted by ONC, as
described in section II.B.8.a. of this final rule, § 423.160(b)(1) will require use of NCPDP
SCRIPT standard version 2023011, which ONC is adopting at 45 CFR 170.205(b)(2), beginning
January 1, 2028, and retire use of NCPDP SCRIPT standard version 2017071, which ONC
previously adopted at 45 CFR 170.205(b)(1) and to which it is applying an expiration date of
January 1, 2028. As both NCPDP SCRIPT standard version 2017071 and NCPDP SCRIPT
standard version 2023011 will be adopted at 45 CFR 170.205(b) and unexpired as of the

effective date of this final rule, entities subject to the requirement at § 423.160(b)(1) may use
either version of the NCPDP SCRIPT standard during the transition period beginning the
effective date of this final rule, and ending December 31, 2027, which is the last day before
NCPDP SCRIPT standard version 2017071 will expire for the purposes of HHS use.
5. Requiring NCPDP Real-Time Prescription Benefit (RTPB) Standard Version 13
In the May 2019 final rule, which implemented the statutory provision at section 1860D–
4(e)(2)(D) of the Act, CMS required at § 423.160(b)(7) that Part D plan sponsors implement, by
January 1, 2021, one or more electronic RTBT capable of integrating with at least one
prescriber’s e-prescribing system or EHR to provide prescribers with complete, accurate, timely,
clinically appropriate, patient-specific formulary and benefit information. CMS indicated that the
formulary and benefit information provided by the tool should include cost, clinically
appropriate formulary alternatives, and utilization management requirements because, at that
time, an industry standard for RTBTs had not been identified (84 FR 23833). NCPDP has since
developed and tested the NCPDP RTPB standard for use with RTBT applications. The NCPDP
RTPB standard enables the real-time exchange of information about patient eligibility and
patient-specific formulary and benefit information. For a submitted drug product, the NCPDP
RTPB standard will indicate coverage status, coverage restrictions, and estimated patient
financial responsibility. “Estimated” financial responsibility accounts for the fact that the RTPB
transaction transmits the patient’s cost sharing at that particular moment in time, which could
later change if the claim is processed at a later date or in a different sequence relative to other
claims (for example, an RTPB transaction could show a cost sharing that reflects a deductible or
particular stage in the Part D benefit which could be different from when the prescription claim
is actually processed by the pharmacy if other claims were processed in the interim). The
NCPDP RTPB standard also supports providing information on alternative pharmacies and
products. In an August 20, 2021 letter to CMS, NCPDP described these features and

recommended adoption of NCPDP RTPB standard version 12.26 Subsequently, in the December
2022 proposed rule, CMS proposed that Part D sponsors’ RTBTs comply with NCPDP RTPB
standard version 12. In response to that proposal, NCPDP and many other interested parties
provided comments to CMS recommending that CMS instead require NCPDP RTPB standard
version 13. In their comments on the December 2022 proposed rule, 27 NCPDP listed
enhancements in NCPDP RTPB standard version 13 that improve the information communicated
between the payer and the prescriber. These enhancements include-● Addition of a Coverage Status Message to enable the payer to communicate at the
product level coverage information that is not codified (that is, values that are not discrete data
elements or specific code values);
● Addition of values to the Coverage Restriction Code and data elements to codify
information communicated and reduce the number of free text messages on the response;
● Addition of a next available fill date to communicate when the patient is eligible to
receive a prescription refill in a discrete field instead of via a free text message;
● Addition of fields to communicate formulary status and preference level of both
submitted and alternative products in order to clarify pricing; and
● Addition of data elements on the request transaction to convey the patient’s address,
state/province, zip/postal code and country to aid in coverage determinations.
Though we withdrew the proposals contained in section III.S. Standards for Electronic
Prescribing in the December 2022 proposed rule (87 FR 79548), we considered comments we
received on the December 2022 proposed rule when crafting the proposals related to RTBTs
discussed in this final rule. A commenter on the December 2022 proposed rule requested that
CMS specify that adoption of the NCPDP RTPB standard should not impede what the

26https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStan

dardsAdoptionRequest.pdf
27https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPR
M.pdf

commenter refers to as the industry standard of sending 4 drugs or 4 pharmacies for pricing in a
single transaction. We understand that each transaction between a prescriber EHR and the payer
or processor is associated with a degree of latency (that is, the amount of time it takes for the
RTBT request to travel from the electronic prescribing system to the payer or processor and
return a response with the patient’s cost sharing and formulary status information for the
submitted drug). In order to populate information on alternative formulary drugs or alternative
pharmacies, if one alternative is submitted per transaction, then the latency associated with each
transaction becomes additive. If the total latency is too long, then either the RTBT request may
“time out” and a response may never be presented to the prescriber, or the prescriber may simply
not wait long enough for the RTBT response before moving on through the electronic
prescribing process. To illustrate the concept at the center of this issue, if each RTBT transaction
is associated with 1 second of latency, then 1 transaction containing the submitted drug, plus 3
alternatives should return the patient-specific cost and formulary status information for all 4
drugs within 1 second. However, if the submitted drug and each alternative are sent as separate
transactions, then the total time to return the RTBT response becomes 4 seconds (1 second x 4
transactions). This longer response time increases the likelihood that the prescriber will not wait
for the information to populate or that the EHR system will cause the transaction to time out,
meaning the patient-specific cost and formulary status information are not presented to the
prescriber. CMS takes interest in how adoption of the proposed NCPDP RTPB standard version
13 could alter functionality of RTBTs already in use. CMS created requirements for RTBTs in
the absence of an industry-wide standard because of their potential to increase drug price
transparency and lower out-of-pocket costs for Medicare Part D enrollees. The impact of RTBTs
is contingent on prescribers actually receiving the patient-specific information in the response
from the payer. CMS appreciates that this is relatively new technology and that there are multiple

factors that contribute to the overall impact of RTBTs in real-world settings.28,29,30 Nevertheless,
we sought comment in the November 2023 proposed rule on the issue raised by the commenter
in the December 2022 proposed rule.
We solicited interested parties for their perspective on whether requiring the NCPDP
RTPB standard version 13 would limit the ability to send more than one drug or pharmacy per
RTBT transaction, and if so, whether the benefit of adopting a standard for prescriber RTBTs in
order to enable widespread integration across EHRs and payers outweighs such limitation.
The NCPDP RTPB standard version 13 standard is designed for prescriber, not
beneficiary (that is, consumer), RTBTs. CMS emphasizes that we did not propose a required
standard for beneficiary RTBTs. Beneficiary RTBTs are made available directly to Part D plan
enrollees by the Part D sponsor; therefore, beneficiary RTBT applications do not necessarily
interface with an electronic prescribing system or EHR, as prescriber RTBTs must.
Consequently, CMS believes that Part D sponsors can retain the flexibility to use beneficiary
RTBTs that are based on an available standard or a custom application, as long as the
information presented to enrollees meets CMS’s requirements codified at § 423.128(d)(4). The
requirements for the beneficiary RTBT are discussed in the final rule titled “Medicare and
Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare
Cost Plan Program, and Programs of All-Inclusive Care for the Elderly,” which appeared in the
January 19, 2021 Federal Register (86 FR 5864). We declined to propose a standard for
beneficiary RTBTs, however we welcomed comments on this topic to consider for future
rulemaking.

Everson J, Dusetzina SB. Real-time Prescription Benefit Tools—The Promise and Peril. JAMA Intern Med.
2022;182(11):1137–1138. doi:10.1001/jamainternmed.2022.3962.
29 Real-Time Benefit Check: Key Insights and Challenges. May 2021. Accessed January 1, 2023. Available at:
https://www.hmpgloballearningnetwork.com/site/frmc/cover-story/real-time-benefit-check-key-insights-andchallenges.
30 American Medical Association. Council on Medical Service. Access to Health Plan Information regarding LowerCost Prescription Options (Resolution 213-NOV-20). Available from https://councilreports.amaassn.org/councilreports/downloadreport?uri=/councilreports/n21_cms_report_2.pdf

As discussed in section II.B.8.b. of this rule, ONC proposed to adopt the NCPDP RTPB
standard version 13 at 45 CFR 170.205(c)(1). We therefore proposed at § 423.160(b)(5) to
require that beginning January 1, 2027, Part D sponsors’ prescriber RTBT must comply with a
standard in 45 CFR 170.205(c).
We solicited comment on these proposals and the related issues raised. A discussion of
the comments received, along with our responses, follows.
Comment: All commenters supported the proposal to require NCPDP RTPB standard
version 13 for prescriber RTBTs implemented by Part D sponsors. Several commenters shared
their support for CMS’s efforts to require a standard to improve transparency and efficiency in
the electronic prescribing process for both prescribers and patients. Many commenters expressed
support for the standard as a means to move away from limited proprietary RTBTs and move
towards widespread access to accurate, detailed, patient-specific cost and coverage information
for prescribers at the point of prescribing.
Response: We thank commenters for their support and for their enthusiasm towards
utilizing RTBTs generally.
Comment: Several commenters expressed concern over the proposed date of January 1,
2027 when use of NCPDP RTPB standard version 13 would be required.
Response: See section II.A.7. of this rule for discussion of this concern.
Comment: Several commenters shared their thoughts regarding the issue of whether the
number of medications that can be sent in a single request transaction in NCPDP RTPB standard
version 13 would present a barrier to existing RTBT functionality. One commenter did not
believe the standard would pose a barrier and that implementers could still send more than one
transaction simultaneously. Another commenter confirmed that there are occasionally latency
issues, but that overall enhancements offered by NCPDP RTPB standard version 13 would
outweigh any potential latency issues. Commenters noted that even though the initial request

only supports 1 drug per transaction, the response provides multiple alternatives, which meets
the health care industry’s needs.
Response: We thank commenters for their feedback on this topic. We are reassured that
requiring NCPDP RTPB standard version 13 for prescriber RTBTs implemented by Part D
sponsors will meet the health care industry’s needs and will enhance rather than impede existing
RTBT functionality.
Comment: Several commenters opined on the specific information communicated in the
RTBT response. A commenter requested that CMS address the number and order of pharmacy
results based on patient preferences and the frequency and timeliness of Part D plan and RTBT
vendor updates to pharmacy network files. The commenter indicated that pharmacies need a
dispute process when RTBT responses provide inaccurate pharmacy network status.
Other commenters raised the topic of negotiated prices being displayed in RTBT results,
as required for qualifying RTBTs as described in section 119(a) of Subtitle B of Title I, Division
CC of CAA, 2021.31 One commenter supported the use of RTBTs to display a full negotiated
price to improve drug cost transparency. Another commenter expressed concern about disclosing
negotiated prices, stating that disclosure of such information would have anticompetitive effects
and unless CMS and ONC implemented protections to ensure this data is used only to support
patient and consumer decision making, there is potential risk of disclosure of negotiated prices to
third parties through abuse of RTBT transactions.
Response: With respect to the number and ordering of pharmacy results in a transaction
response, the request to address pharmacy ordering in the NCPDP RTPB standard version 13
response transaction results is outside the scope of our proposal. The issue of pharmacy network
status not being updated in a timely manner is also outside the scope of the current proposal
since it relates to Part D plans’ and their vendors’ internal operations. The value of the RTBT is
to provide patient-specific drug coverage information that accurately reflects what an enrollee

Pub. L. 116-260 (December 27, 2020). https://www.congress.gov/bill/116th-congress/house-bill/133

would pay if presenting to a particular pharmacy at that moment in time; therefore, an RTBT
response that does not return accurate information undermines the utility of and confidence in
these tools. Part D sponsors should be ensuring that pharmacy network files are updated in a
timely manner so that when an enrollee indicates their preferred pharmacy to their prescriber, the
RTBT can return accurate coverage information. Pharmacies can also submit complaints to
Medicare for review by CMS if they believe that their network participation status is not being
accurately reflected by a Part D sponsor.32
With respect to display of negotiated prices in the RTBT, the NCPDP RTPB standard
version 13 does not include fields to support the exchange of negotiated prices. We refer
commenters and interested parties to discussion in the May 2019 final rule, in which we
addressed comments received in response to encouraging Part D sponsors to include negotiated
prices in RTBT (84 FR 23850). When we finalized the requirement at § 423.160(b)(7) in the
May 2019 final rule (which we are renumbering to § 423.160(b)(5) in this final rule) for Part D
sponsors to implement, no later than January 1, 2021, one or more RTBTs capable of integrating
with at least one prescriber’s e-prescribing system or electronic health record, we encouraged,
but did not require, Part D sponsors’ RTBTs to include negotiated prices.
CAA, 2021 was then enacted after the May 2019 final rule appeared in the Federal
Register. Section 119(a) of Subtitle B of Title I of Division CC of the CAA, 2021 added section
1860D–4(o) of the Act to require Part D sponsors to implement one or more RTBTs that meet
specified requirements after the Secretary has adopted a standard for RTBTs and at a time
determined appropriate by the Secretary. The law specified that RTBTs must be capable of, with
respect to a covered Part D drug for a specific Part D enrollee, transmitting cost sharing
information and the negotiated price of a drug and its formulary alternatives, among other
requirements. Similarly, section 119(b) of Subtitle B of Title I of Division CC of the CAA, 2021
amended the definition of a “qualified electronic health record” in section 3000(13) of the Public

https://www.medicare.gov/my/medicare-complaint/

Health Service Act to require than a qualified electronic health record include an RTBT capable
of transmitting cost sharing information and the negotiated price of a drug and its formulary
alternatives, among other requirements.
In a proposed rule titled “Health Data, Technology, and Interoperability: Certification
Program Updates, Algorithm Transparency, and Information Sharing” (88 FR 23746), which
appeared in the April 18, 2023 Federal Register, ONC discussed limitations of NCPDP RTPB
standard version 12, specifically that it does not include fields that support the exchange of
negotiated prices. Furthermore, ONC requested comment on pharmacy interoperability
functionality within the ONC Health IT Certification Program, including real-time prescription
benefit capabilities, in which ONC noted that these fields were not included in the NCPDP
RTPB standard due to concerns regarding confidentiality and challenges in determining a
negotiated price in real time (88 FR 23850). Section 119 of Subtitle B of Title I of Division CC
of the CAA, 2021 grants the Secretary of Health and Human Services the authority to determine
the appropriate time, after adopting a standard, to require Part D sponsors to implement and
qualified electronic health records to include, respectively, RTBTs meeting the statutory
requirements. CMS and ONC will continue to work with other interested parties to determine
how and at what time negotiated price information may be made available in RTBTs. At this
time, NCPDP RTPB standard version 13 also lacks fields that support the exchange of negotiated
prices, but it is the best available standard and otherwise meets the statutory requirements for
RTBTs.
Comment: Several commenters provided feedback about beneficiary RTBTs. A
commenter recommended that CMS should adopt the same standard for beneficiary RTBTs that
is used for prescriber RTBTs since the NCPDP RTPB standard, for example, could be adapted to
a consumer-friendly user interface and information that would not be relevant in a beneficiaryfacing context could be suppressed. Other commenters noted that the NCPDP RTPB standard
was not designed to support a beneficiary RTBT and therefore would not be an appropriate

standard for that purpose. A commenter agreed that there is no immediate need to require a
standard for beneficiary RTBTs. A commenter emphasized that it is essential for pricing and
coverage information displayed in beneficiary RTBTs to match the information provided in
prescriber RTBTs, therefore any required standard for beneficiary RTBTs must guarantee that
information shared is consistent.
Response: We thank commenters for their input and may consider it to inform future
rulemaking.
Comment: A commenter suggested that RTBTs should be embedded within the
EMR/EHR workflow.
Response: We thank the commenter for being eager to integrate RTBTs into their
practice; however, the manner in which the NCPDP RTPB standard and other standards are
incorporated into EMR/EHR design and workflow is outside the scope of this proposal. We refer
the commenter to section III.G.2. of the final rule titled “Health Data, Technology, and
Interoperability: Certification Program Updates, Algorithm Transparency, and Information
Sharing” (89 FR 1192), which appeared in the January 9, 2024 Federal Register, and which
describes ONC’s approach to considering updates to the ONC Health IT Certification Program
that could support the availability of RTBTs in certified health IT for use by health care
providers.
Comment: CMS received several comments regarding use of RTBTs. A commenter
requested that pharmacists have access to RTBTs. Another commenter requested an exception to
the use of RTBTs in LTC or institutional levels of care. A commenter encouraged CMS and
ONC to monitor physician utilization of RTBTs to consider the impact in Part D and address
barriers to access in future regulation.
Response: With respect to pharmacists accessing RTBTs, nothing in § 423.160, standards
for electronic prescribing, limits RTBT access to particular health care providers where
consistent with applicable law. Our understanding is that a decision to expand access to RTBTs

to non-prescribing providers, such as pharmacists or other members of a clinical care team,
would be made by each health system.
With respect to the request for an exemption from the use of RTBTs in LTC or
institutional levels of care, we point out that Part D regulations have never imposed a
requirement with respect to the utilization of RTBTs by prescribers. Since January 1, 2021, CMS
has required that Part D sponsors implement at least one RTBT capable of integrating with at
least one prescriber’s e-prescribing system or EHR. Our proposal to require that by January 1,
2027, the Part D sponsor RTBT must comply with NCPDP RTPB standard version 13, which
ONC is adopting at 45 CFR 170.205(c)(1), does not impose any new requirement on prescribers
to integrate RTBTs into their e-prescribing systems or EHRs or to utilize RTBTs.
With respect to monitoring real-world use of RTBTs, we intend to monitor the published
literature and will explore other vehicles for monitoring progress in this area as resources permit.
After consideration of the public comments we received, we are finalizing the
requirement as proposed at § 423.160(b)(5) that beginning January 1, 2027, Part D sponsors’
prescriber RTBT must comply with a standard in 45 CFR 170.205(c), where ONC is adopting
the NCPDP RTPB standard version 13 at 45 CFR 170.205(c)(1) as described in section II.B.8.b.
of this rule.
6. Requiring NCPDP Formulary and Benefit Standard Version 60 and Retirement of NCPDP
Formulary and Benefit Standard Version 3.0
The NCPDP Formulary and Benefit (F&B) standard provides a uniform means for
prescription drug plan sponsors to communicate plan-level formulary and benefit information to
prescribers through electronic prescribing/EHR systems. The NCPDP F&B standard transmits,
on a batch basis, data on the formulary status of drugs, preferred alternatives, coverage
restrictions (that is, utilization management requirements), and cost sharing consistent with the
benefit design (for example, cost sharing for drugs on a particular tier). The NCPDP F&B
standard serves as a foundation for other electronic prescribing functions including ePA,

real-time benefit check, and specialty medication eligibility when used in conjunction with other
standards.33 NCPDP F&B standard version 3.0 is required for transmitting formulary and
benefits information between prescribers and Medicare Part D sponsors, consistent with the text
of §§ 423.160(b)(1)(v) and 423.160(b)(5)(iii). In an April 4, 2023 letter to CMS, NCPDP
requested that CMS adopt NCPDP F&B standard version 60 to replace NCPDP F&B standard
version 3.0.34 A detailed change log was attached to the letter and is available at the link in the
footnote. As described in the letter, compared with NCPDP F&B standard version 3.0, NCPDP
F&B standard version 60 includes all of the following major enhancements:
● Normalization of all files (lists), which allows for smaller files and reusability.
● All files have expiration dates.
● Redesigned alternative and step medication files to reduce file sizes and to include
support for reason for use (that is, diagnosis).
● Step medication files support a more complex step medication program.
● Updated coverage files to include support for electronic prior authorization and
specialty drugs.
● Updated copay files to allow a minimum and maximum copay range without a percent
copay and to support deductibles and pharmacy networks.
In its letter to CMS, NCPDP requested mandatory use of NCPDP F&B version 60
24 months after the effective date of a final rule adopting the standard. NCPDP F&B standard
version 60 is backwards compatible with NCPDP F&B standard version 3.0, permitting a
transition period where both versions of the NCPDP F&B standard may be used simultaneously
without the need for entities involved to utilize a translator program.

Babbrah P, Solomon MR, Stember LA, Hill JW, Weiker M. Formulary & benefit and real-time pharmacy Benefit:
Electronic standards delivering value to prescribers and pharmacists. J Am Pharm Assoc (2003). 2023 MayJun;63(3):725-730. doi: 10.1016/j.japh.2023.01.016.
34 https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230404-to-CMS-Formulary-andBenefit-V60-Request.pdf
Following an approach similar to those discussed in sections II.A.4. and II.A.5. of this
rule, CMS proposed at § 423.160(b)(3) that electronic transmission of formulary and benefit
information between prescribers and Medicare Part D sponsors must either utilize NCPDP F&B
standard version 3.0 or comply with a standard in 45 CFR 170.205(u), where ONC proposed to
adopt, at 45 CFR 170.205(u)(1), NCPDP F&B standard version 60 as described in section
II.B.8.c. of this rule. CMS proposed that beginning January 1, 2027, entities transmitting
formulary and benefit information would be required to comply with a standard in 45 CFR
170.205(u) exclusively. As a result of these proposals, there would be a transition period where
either NCPDP F&B standard version 3.0 or NCPDP F&B standard version 60 could be used
until January 1, 2027. Since ONC did not previously adopt NCPDP F&B standard version 3.0,
we would be maintaining adoption of the standard at § 423.160(b)(3) (previously adopted at
§ 423.160(b)(5)(iii)) and the incorporation by reference of that version in the Part D regulation at
§ 423.160(c)(1).
We solicited comment on these proposals. A discussion of the comments received, along
with our responses, follows.
Comment: All commenters supported the proposal to update NCPDP F&B standard
version 3.0 to NCPDP F&B standard version 60. Several commenters acknowledged the
complementary role of the NCPDP F&B standard with NCPDP SCRIPT and NCPDP RTPB
standards.
Response: We thank commenters for their support.
Comment: Several commenters expressed concern over the proposed date of January 1,
2027 when use of the NCPDP F&B standard version 60 would be required.
Response: For a discussion of the responses to these comments, see section II.A.7. of
this rule.
After consideration of the public comments received, we are finalizing the requirement,
beginning January 1, 2027 and as proposed at § 423.160(b)(3), for transmission of formulary and

benefit information between Medicare Part D sponsors and prescribers to comply with a standard
in 45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60. We are
finalizing our proposal to retire use of NCPDP F&B standard version 3.0 for transmitting
formulary and benefit information between prescribers and Part D sponsors effective January 1,
2027. A transition period where entities will be permitted to use either NCPDP F&B standard
version 3.0 (named at § 423.160(b)(3) consistent with the technical changes in this rule) will
begin on the effective date of the final rule and continue through December 31, 2026. Beginning
January 1, 2027, only a version of the standard adopted for HHS use at 45 CFR 170.205(u) will
be permitted for use, which will be NCPDP F&B standard version 60 as described in section
II.B.8.c. of this rule.
7. Date for Required Use of NCPDP SCRIPT Standard Version 2023011, NCPDP RTPB
Standard Version 13, and NCPDP F&B Standard Version 60 and Transition Period for NCPDP
SCRIPT and F&B standards
As discussed in the November 2023 proposed rule, we have received feedback on a
number of practical considerations for determining a realistic timeframe to implement new or
update existing electronic prescribing standards. We have been informed that organizations
generally do not budget for new requirements until a final rule has been published establishing a
particular new requirement and, therefore, the timing of when a final rule is finalized relative to
budget approval cycles can determine if a requirement can be accounted for in the organization’s
next annual budget. The health IT industry has indicated to CMS that it requires at least 2 years
to design, develop, test, and certify software with trading partners; perform DEA audits for
EPCS compliance; and roll out updated software to provider organizations and partners who then
must train end users before a transition to a new or updated version of a standard is complete.
This account is consistent with NCPDP’s requests for up to 24-month implementation

timeframes for new standards.35,36 A commenter on the December 2022 proposed rule requested
that CMS either permit 3 years from a final rule before requiring use of a new or updated version
of a standard, or use enforcement discretion if requiring use of a new or updated version of a
standard less than 3 years from a final rule. CMS will generally aim to provide entities with at
least 2 years from when a final rule is finalized. However, we qualify that in some cases less time
may be provided if determined to be necessary.
We routinely receive feedback requesting that we do not require the use of new or
updated electronic prescribing standards starting on January 1 due to end-of-year “code freezes,”
which prohibit updates to internal systems and plan enrollment changes that contribute to a
general high workload at the start of a new plan year. We remind entities impacted by the
proposed regulatory changes that, consistent with § 423.516, we are prohibited from imposing
new, significant regulatory requirements on Part D sponsors midyear. Consistent with the
approach discussed in this rule to align CMS’ requirements for certain Part D electronic
prescribing standards by cross-referencing standards adopted in ONC regulations, CMS and
ONC will coordinate to establish appropriate timeframes for updating adopted standards and
expiration dates for prior versions of adopted standards. CMS, working with ONC, will consider
transition periods longer than 24 months following publication of a final rule to permit a
sufficient transition period prior to January 1. Since a new, significant requirement must be
effective January 1, a new or updated version of a standard could be required January 1 of the
year following 24 months after a final rule is effective. Part D sponsors would need to plan
accordingly to completely transition to the updated version of the standard ahead of the January
1 date to meet their internal production calendars.

35https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStan

dardsAdoptionRequest.pdf
36 https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDPSCRIPTNextVersionLetter.pdf

ONC proposed January 1, 2027, as the date NCPDP SCRIPT standard version 2023011
would be the required version of this standard, as a product of the proposed expiration for
NCPDP SCRIPT standard version 2017071 and our proposed cross-reference in § 423.160(b)(1)
to a standard in 45 CFR 170.205(b). We proposed the required use of NCPDP F&B standard
version 60 and NCPDP RTPB standard version 13 by January 1, 2027, in the text of
§§ 423.160(b)(3) and (5) via cross-reference to a standard in 45 CFR 170.205(u) and 170.205(c),
respectively. As discussed in sections II.A.4 and II.A.6 of this rule, since NCPDP SCRIPT
standard version 2023011 and NCPDP F&B standard version 60 are backwards compatible with
NCPDP SCRIPT standard version 2017071 and NCPDP F&B standard version 3.0, respectively,
we proposed to permit a transition period when either version could be used. The transition
period would begin upon the effective date of the final rule and end on January 1, 2027, which is
the expiration date for NCPDP SCRIPT standard version 2017071 proposed by ONC and the
date after which CMS proposed to no longer permit use of NCPDP F&B standard version 3.0.
We are also aware that Part D sponsors and the health IT industry are awaiting HHS’
final rule on the proposals to update the NCPDP Telecommunication standard from version D.0
to version F6 (87 FR 67638), update the equivalent NCPDP Batch Standard version 15 (87 FR
67639), and implement the NCPDP Batch Standard Pharmacy Subrogation version 10 (87 FR
67640) proposed in the November 2022 Administrative Simplification proposed rule.
Taking all of these proposals into consideration, we asked interested parties to comment
on the proposed January 1, 2027 date for the required use of NCPDP SCRIPT standard version
2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60. We noted
that the compliance date for the proposals in HHS’ November 2022 Administrative
Simplification proposed rule was expressly outside the scope of our proposals, and we did not
seek comment on it; however, we solicited comments on the feasibility of updating multiple
standards simultaneously. A discussion of the comments received, along with our responses,
follows.

Comment: Most commenters supported January 1, 2027 as the date for required use of
NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP
F&B standard version 60.
Response: We thank commenters for their support.
Comment: Several commenters requested that the date for required use of NCPDP
SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B
standard version 60 be delayed to January 1, 2028. Commenters expressed concern with
implementing multiple standards simultaneously at a time when Part D plan and pharmacy
benefit manager resources are also focused on system changes related to sections of the Inflation
Reduction Act of 202237 that impact Part D sponsors and take effect in 2025 and 2026. A
commenter indicated that updating standards in the LTC setting are uniquely challenging such
that necessary changes could not be implemented before June 30, 2027.
Response: We acknowledge these concerns and seek to strike a balance between
advancing standards and providing a reasonable timeline for the health care industry to
implement standards successfully. When considering this request, we considered when each
standard was last updated and competing needs of the health care industry that each standard
addresses. For example, the last time we adopted a newer version of the NCPDP F&B standard
was in 2015 (78 FR 74789), whereas we adopted a newer version of the NCPDP SCRIPT
standard in 2020 (83 FR 16637). As discussed in section II.A.5. of this rule, we have not
previously required a standard for prescriber RTBTs implemented by Part D sponsors, and many
commenters supported adoption of a standard in order to enable widespread prescriber access to
real-time pharmacy benefit information for their patients at the time of prescribing.
We are concerned that delaying the full and required implementation of all standards
until January 1, 2028 would create a scenario where, by the time impacted parties have
implemented NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13,

Pub. L. 117-169. https://www.congress.gov/bill/117th-congress/house-bill/5376/text

and NCPDP F&B standard version 60, NCPDP will have already created newer versions that
merit adoption. We are aware of the challenges that are created when cycles of updating
standards and adoption in regulation do not occur in tandem. CMS and ONC are open to working
with standards development organizations and health care industry representatives to improve
the process through which updated standards are incorporated into regulation in the future such
that updates can be made in a timely manner.
CMS and ONC have taken the aforementioned factors and comments received into
account and are delaying the required use of NCPDP SCRIPT standard version 2023011 to
January 1, 2028. We are finalizing this change by finalizing the proposed § 423.160(b)(1),
which requires compliance with a standard in 45 CFR 170.205(b), in conjunction with ONC
finalizing January 1, 2028 as the expiration date for NCPDP SCRIPT standard version 2017071
in 45 CFR 170.205(b)(1) (as discussed in section II.B.8.a. of this final rule). We are finalizing
without modification the requirement to use NCPDP F&B standard version 60 by January 1,
2027 by requiring at § 423.160(b)(3), beginning January 1, 2027, compliance with a standard in
45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60 (as discussed in
section II.B.8.c. of this final rule). We are finalizing the requirement to use NCPDP RTPB
standard version 13 by January 1, 2027 by requiring at § 423.160(b)(5), beginning January 1,
2027, compliance with a standard in 45 CFR 170.205(c), where ONC is adopting NCPDP RTPB
standard version 13 (as discussed in section II.B.8.b. of this final rule). The NCPDP F&B
standard has not been updated as recently as the NCPDP SCRIPT standard has been updated
from the perspective of Part D requirements. Further, we believe that maintaining the proposed
timeline to require use of NCPDP RTPB standard version 13 and exclusive use of NCPDP F&B
standard version 60 by January 1, 2027 is warranted in order to support prescribers’ access to
accurate cost and coverage information at the point of prescribing through use of these
complimentary standards.

Comment: A few commenters provided feedback on the transition periods permitted by
CMS’ proposals. A commenter offered general support for permitting transition periods when
backwards compatible versions of standards are available since such periods offer flexibility to
the health IT industry and all entities subject to Part D electronic prescribing requirements.
Another commenter indicated that if CMS is not specifying the exact dates of transition periods
in regulation, there may be confusion among health IT vendors with respect to when system
updates can begin. The commenter requested that CMS provide additional communication to the
health IT vendor community.
Response: As discussed in section II.A.8. of this rule, we believe, and most commenters
agree, that the aligned approach between CMS and ONC will help alleviate compliance
challenges for the health IT vendor community, but we acknowledge that our proposed approach
to cross-reference ONC regulations in Part D regulations in § 423.160 is a significant change
from the previous approach of naming standards and specific transition periods in the Part D
regulations. Part D sponsors will need to engage with their health IT vendors following the
effective date of this, and future, final rules to plan for the transition to new required standards.
We do not generally intend to specify dates for transition periods in regulation in the future, but
we will consider additional means of communicating the updated requirements to Part D
sponsors, including specifying the dates of transition periods, to minimize any confusion.
After consideration of the public comments received, we are finalizing the requirement
for exclusive use of NCPDP SCRIPT standard version 2023011 by January 1, 2028 as a result of
ONC modifying the proposed expiration date for NCPDP SCRIPT standard version 2017071 at
45 CFR 170.205(b)(1) as discussed in section II.B.8.a. of this rule. The transition period during
which either NCPDP SCRIPT standard version 2017071 or NCPDP SCRIPT standard version
2023011 may be used will begin on July 7, 2024, the effective date of this final rule, and end on
December 31, 2027. We are finalizing the requirement for exclusive use of NCPDP F&B
standard version 60 by January 1, 2027 as proposed by requiring at § 423.160(b)(3), beginning

January 1, 2027, compliance with a standard in 45 CFR 170.205(u), where ONC is adopting
NCPDP F&B standard version 60 (as discussed in section II.B.8.c. of this final rule). The
transition period during which either NCPDP F&B standard version 3.0 or NCPDP F&B
standard version 60 can be used, will begin on July 7, 2024, the effective date of this final rule,
and end on December 31, 2026. We are finalizing the required use of NCPDP RTPB standard
version 13 for prescriber RTBTs supported by Part D sponsors by January 1, 2027 as proposed
by requiring at § 423.160(b)(5), beginning January 1, 2027, compliance with a standard in 45
CFR 170.205(c), where ONC is adopting NCPDP RTPB standard version 13 (as discussed in
section II.B.8.b. of this final rule).
8. CMS-ONC Aligned Approach to Adoption of Electronic Prescribing Standards
We proposed a novel approach to updating e-prescribing standards by cross-referencing
Part D e-prescribing requirements with standards, including any expiration dates, adopted by
ONC, as discussed in section II.B.5. of this rule. The proposed approach would enable CMS and
ONC to avoid misalignment from independent adoption of standards for their respective
programs. Updates to the adopted standards would impact requirements for both programs at the
same time, ensure consistency, and promote alignment for providers, payers, and health IT
developers participating in and supporting the same prescription transactions. A discussion of the
comments received on our proposal, along with our responses, follows.
Comment: The majority of commenters supported the proposed aligned approach and
agreed that it would alleviate compliance challenges for developers and generally help promote
consistency and coordination among all parties implementing new standards.
Response: We thank commenters for their support.
Comment: A few commenters did not support or expressed concerns about the aligned
approach. A commenter raised the point that Part D sponsors are not required to use certified
health IT; therefore, the approach to cross-reference standards adopted by ONC in Part D
regulation could create confusion about the scope of ONC requirements. A few commenters

emphasized that CMS and ONC need to assure process alignment across agencies when ONC
adopts new standards so that CMS representatives continue to be involved in determining the
new requirements and timing. A commenter noted that there should be a notification process,
such as a Federal Register announcement or Health Plan Management System (HPMS)
memorandum to inform Part D sponsors if ONC plans to update the adopted standards in the
future.
Response: We thank commenters for sharing their concerns and recommendations. We
agree that the success of the proposed aligned approach with cross-references is contingent on
collaboration and communication among CMS, ONC, and the entities that are subject to CMS
and ONC requirements. CMS and ONC will continue to work together on future rulemaking to
ensure that future standards that are adopted meet the needs of the respective programs. We will
consider the means to ensure that the relevant entities are notified of proposed rules as they are
published in the Federal Register for public comment and are notified of final rules that finalize
relevant proposals. As described in section II.A.11. of this rule, in order for CMS to require use
of standards in § 423.160 by cross citation to 45 CFR 170.205(b), (c), and (u), those standards
must be published in full in the Federal Register or CFR. Therefore, CMS will be required to
incorporate by reference in § 423.160 the standards that ONC updates at 45 CFR 170.205(b), (c),
and (u). We believe the incorporation by reference in § 423.160 will help to mitigate confusion
regarding the standards that are applicable to Part D requirements. We acknowledge that since
the expiration dates of standards will be located in ONC regulations, CMS will consider a
targeted announcement to Part D sponsors via HPMS memorandum or email. CMS will continue
to participate in NCPDP task groups to ensure that Part D sponsors, pharmacies, and prescribers
can continue to coordinate with CMS on issues and challenges related to electronic prescribing
standards in Part D. In turn, CMS will work closely with ONC to ensure that any concerns
related to electronic prescribing standards in Part D are considered in future rulemaking.

Comment: A commenter recommended that CMS should maintain its own standards
version advancement process (SVAP) that is focused on the needs of health plans, since the ONC
Health IT Certification Program is focused on providers and health IT vendors.
Response: We thank the commenter for their recommendation. ONC’s SVAP permits
health IT developers to voluntarily update health IT products certified under the ONC Health IT
Certification Program (Certification Program) to newer versions of adopted standards as part of
the “Real World Testing” Condition and Maintenance of Certification requirement at 45 CFR
170.405.38 Although the ONC SVAP permits the use of newer versions of adopted standards in
its ONC Health IT Certification Program, this flexibility does not extend to the Part D program
requirements for electronic prescribing. Entities to which the requirements at § 423.160 apply
must only use the standard version or versions specified in regulation. We did not propose an
equivalent process to ONC’s SVAP process for Part D sponsors’ electronic prescription drug
programs but will take the idea into consideration for future rulemaking.
Comment: A commenter recommended that CMS and ONC consider aligning federal
requirements for electronic prescribing standards with state requirements or to encourage states
to follow standards and timelines adopted at the federal level.
Response: The recommendation is outside the scope of our proposals. State regulators
may refer to federal regulations to inform requirements related to electronic prescribing
standards at the state level.
After consideration of the public comments we received, we are finalizing our proposals
to update e-prescribing standards by cross-referencing Part D e-prescribing requirements with
standards, including any expiration dates, adopted by ONC, as discussed in section II.B.5. of this
rule.

https://www.healthit.gov/topic/standards-version-advancement-process-svap

9. Standards for Eligibility Transactions
We proposed to revise the Part D requirements to indicate that eligibility transactions
must comply with 45 CFR 162.1202. The requirements for eligibility transactions currently
codified at § 423.160(b)(3)(i) and (ii) name the Accredited Standards Committee X12N 270/271Health Care Eligibility Benefit Inquiry and Response, Version 5010, April 2008, ASC
X12N/005010x279 and the NCPDP Telecommunication Standard Specification, Version D,
Release 0 (Version D.0), August 2007, and equivalent NCPDP Batch Standard Batch
Implementation Guide, Version 1, Release 2 (Version 1.2), January 2006 supporting
Telecommunications Standard Implementation Guide, Version D, Release 0 (Version D.0),
August 2007. We adopted these standards to align with those adopted at 45 CFR 162.1202,
pursuant to the final rule titled “Health Insurance Reform; Modifications to the Health Insurance
Portability and Accountability Act (HIPAA) Electronic Transaction Standards,” which appeared
in the January 16, 2009 Federal Register (74 FR 3326).
The November 2022 Administrative Simplification proposed rule proposes to update the
HIPAA standards used for eligibility transactions (87 FR 67634). We therefore proposed to
update the Part D regulation by proposing, at § 423.160(b)(2), that eligibility inquiries and
responses between the Part D sponsor and prescribers and between the Part D sponsor and
dispensers would have to comply with the applicable HIPAA regulation in 45 CFR 162.1202, as
opposed to naming standards independently, which would ensure, should the HIPAA standards
for eligibility transactions be updated as a result of HHS rulemaking or in the future, that the Part
D regulation would be synchronized with the required HIPAA standards. We foresee no
immediate impact of this proposed change since the HIPAA regulation at 45 CFR 162.1202
currently identifies the same standards as those named in the Part D regulation at
§ 423.160(b)(3)(i) and (ii), but we believe establishing a cross-reference would help avoid
potential future conflicts and mitigate potential compliance challenges for the health care
industry and enforcement challenges for HHS.

Thus, we proposed to delete existing paragraphs §§ 423.160(b)(3)(i) and (ii) and modify
paragraph § 423.160(b)(2) (as renumbered per the technical revisions discussed in section
II.A.10. of this rule) to require that eligibility transactions must comply with 45 CFR 162.1202.
We solicited comment on these proposals. A discussion of the comments received, along
with our responses, follows.
Comment: All comments received on this proposal were supportive. Several commenters
agreed that the cross-reference to HIPAA regulation will alleviate compliance challenges for
those required to comply with Part D and HIPAA regulations.
Response: We thank commenters for their support.
Comment: A commenter requested that CMS institute a notification process to ensure that
entities subject to Part D requirements are made aware of updates when HHS updates the
required standards for eligibility transactions.
Response: Consistent with 45 CFR 162.100, the regulations at 45 CFR 162.1202 apply to
covered entities as defined at 45 CFR 160.103. Entities subject to Part D regulations are among
those covered entities.39 We believe that HHS has the means to reach covered entities when it
undertakes rulemaking and when new requirements are finalized. Therefore, we do not believe
CMS would need to issue separate notice.
After consideration of the public comments we received, we are finalizing, in §
423.160(b)(2), the cross-reference to 45 CFR 162.1202 for eligibility transactions as proposed.
10. Technical Changes throughout § 423.160
In the spirit of alignment with ONC’s approach to adopting standards, we reviewed
§ 423.160 in its entirety and identified areas where we could reorganize text throughout this
section. We do not believe we should continue to list historical requirements that are no longer
relevant and have resulted in repetitive content being added to the regulations. We proposed

https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/coveredentities
removing reference to old effective dates (for example, “After January 1, 2009…” at
§ 423.160(a)(3)(ii)). Additionally, certain exemptions have long since expired. For example, at
§ 423.160(a)(3)(iv), entities transmitting prescriptions or prescription-related information where
the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider
(such as a nursing facility) that in turn forwards the prescription to a dispenser have not been
exempt from using the SCRIPT standard since November 1, 2014.
We proposed a correction at § 423.160(a)(3)(iii), where regulation text refers to
prescriptions and prescription-related information transmitted “internally when the sender and
the beneficiary are part of the same legal entity.” The exemption currently at § 423.160(a)(3)(iii)
was previously codified at § 423.160(a)(3)(ii) as “Entities may use either HL7 messages or the
NCPDP SCRIPT Standard to transmit prescriptions or prescription-related information internally
when the sender and the recipient are part of the same legal entity…” as finalized in the
November 2005 final rule, which codified the foundation standards for Medicare Part D
electronic prescription drug programs (70 FR 67594). Paragraph § 423.160(a)(ii) was
redesignated as paragraph § 423.160(a)(iii) subsequent to changes made in the final rule titled
“Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and
Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance
Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the EPrescribing Exemption for Computer Generated Facsimile Transmissions,” (hereinafter referred
to as “the November 2007 final rule”) which appeared in the November 27, 2007 Federal
Register (72 FR 66222). There is no indication of intent in the November 2007 final rule to
change the wording in § 423.160(a)(iii) when it was redesignated, nor can we find evidence of
when this paragraph may have been altered in subsequent rules. Therefore, we believe the word
“recipient” was inadvertently changed to “beneficiary” in the distant past, and we proposed to
change this back to “recipient.”

Paragraphs § 423.160(a)(1)-(2) already indicate that the entities listed must comply with
the applicable standards in § 423.160(b); therefore, the language currently at § 423.160(b)(1),
“Entities described in paragraph (a) of this section must comply with the following adopted
standards for transactions under this section,” is redundant. We proposed to remove it from the
text of § 423.160(b)(1). Moreover, §§ 423.160(b)(1)(i) through (iv) and 423.160(b)(2)(i) through
(iii) contain long-outdated requirements going back to the start of the electronic prescribing
program in Medicare Part D. We proposed to delete references to outdated requirements so that
the regulation text would include only relevant and applicable requirements. Transition periods
would no longer be specifically spelled out as starting at a particular date (historically, 6 months
after the effective date of a final rule). Rather, the transition period would begin as of the
effective date of a final rule effectuating a change from one version of a standard to a new
version and would last until the prior version of the standard is expired, as proposed to be
codified in ONC regulation, or until the date specified in Part D regulation. For versions of
standards adopted by ONC, CMS will consider the necessary transition period when working
with ONC to establish the appropriate expiration date for prior versions of standards in
rulemaking. This would align the Part D approach with the approach that ONC has used in its
own regulations.
As currently organized, separate sections for “Prescription” at § 423.160(b)(2),
“Medication History” at § 423.160(b)(4), and “Electronic Prior Authorization” at
§ 423.160(b)(8) have resulted in multiple versions of the NCPDP SCRIPT standard, and relevant
transactions, being repeated in these sections. Because §§ 423.160(a)(1) and (2) state that the
entities listed must comply “with the applicable standards in paragraph (b),” we believe that we
could group the functions in paragraph (b) according to the standard used for those functions to
avoid repetition. Therefore, we proposed to combine “Prescriptions, electronic prior
authorization, and medication history” at § 423.160(b)(1), which would require the use of the
NCPDP SCRIPT standard version or versions as proposed via cross-reference to ONC

regulations. We proposed to delete §§ 423.160(b)(4) and (8). We proposed to relocate the ePA
transactions previously listed at § 423.160(b)(8)(i)(A) through (D) to § 423.160(b)(1)(i)(V)
through (Y). We proposed to delete reference to versions of the NCPDP F&B standard, currently
codified at §§ 423.160(b)(5), 423.160(b)(5)(i), and 423.160(b)(5)(ii), that are no longer
applicable. The remaining paragraphs in § 423.160(b) would be renumbered such that §
423.160(b)(2) would refer to eligibility, § 423.160(b)(3) would refer to formulary and benefits, §
423.160(b)(4) would refer to provider identifier, and § 423.160(b)(5) would refer to real-time
benefit tools.
We proposed to delete standards incorporated by reference at § 423.160(c) that are: no
longer applicable (that is, are associated with outdated requirements that we proposed to delete);
or are already incorporated by reference by HHS at 45 CFR 162.920. The standards incorporated
by reference at §§ 423.160(c)(1)(i), (ii), (iv), and (v) would no longer be applicable, and we
proposed to delete them. The standards for eligibility transactions currently incorporated by
reference at §§ 423.160(c)(1)(iii) and 423.160(c)(2) have already been incorporated by reference
by HHS at 45 CFR 162.920. We proposed to delete these incorporations by reference in light of
our proposal in section II.A.9. of this rule to indicate that entities would be required to comply
with 45 CFR 162.1202. That citation indicates where the applicable standards have been
incorporated by reference in HHS regulations.
We believe these changes would improve the overall readability of the section. With the
exception of changes described in sections II.A.4., II.A.5., II.A.6., and II.A.9., we do not intend
for technical changes to alter current requirements.
We solicited comment on these proposals. We received no comments on our proposed
technical changes and the correction and therefore are finalizing them as proposed.
11. Incorporation by Reference and Availability of Incorporation by Reference Materials
The Office of the Federal Register (OFR) has regulations concerning incorporation by
reference (IBR) at 1 CFR part 51. If the regulations reference a standard, either in general or by

name, in another section, IBR approval is required. In order for CMS to require use of standards
in § 423.160 by cross citation to 45 CFR 170.205(b), (c), and (u), those standards must be
published in full in the Federal Register or CFR. Therefore, CMS must incorporate by reference
the materials referenced in the proposals in sections II.A.4., II.A.5., and II.A.6. of this rule which
cross cite standards in ONC regulations.
For a final rule, agencies must discuss in the preamble to the final rule ways that the
materials the agency proposes to incorporate by reference are reasonably available to interested
parties or how the agency worked to make the materials reasonably available. Additionally, the
preamble to the final rule must summarize the materials. See section II.B.10. of this final rule for
summaries of the standards CMS and ONC are incorporating by reference.
Consistent with those requirements, CMS has established procedures to ensure that
interested parties can review and inspect relevant materials. The proposals related to the Part D
electronic prescribing standards have relied on the following materials, which we proposed to
incorporate by reference where specified-● NCPDP SCRIPT Standard, Implementation Guide Version 2017071, (Approval Date
for American National Standards Institute [ANSI]: July 28, 2017), which is currently
incorporated by reference at § 423.160(c)(1)(vii). We proposed to renumber this incorporation by
reference as § 423.160(c)(2);
● NCPDP SCRIPT Standard, Implementation Guide Version 2023011, (Approval Date
for ANSI: January 17, 2023). We proposed to incorporate by reference at § 423.160(c)(3);
● NCPDP Real-Time Prescription Benefit Standard, Implementation Guide Version 13,
(Approval Date for ANSI: May 19, 2022). We proposed to incorporate by reference at
§ 423.160(c)(4);
● NCPDP Formulary and Benefits Standard, Implementation Guide, Version 3, Release 0
(Version 3.0), (Approval Date for ANSI: January 28, 2011), which is currently incorporated by

reference at § 423.160(c)(1)(vi). We proposed to renumber this incorporation by reference as
§ 423.160(c)(1); and
● NCPDP Formulary and Benefit Standard, Implementation Guide Version 60,
(Approval Date for ANSI: April 12, 2023). We proposed to incorporate by reference at
§ 423.160(c)(5).
NCPDP members may access these materials through the member portal at
https://standards.ncpdp.org/Access-to-Standards.aspx. Non-NCPDP members may obtain these

materials for information purposes by contacting CMS at 7500 Security Boulevard, Baltimore,
Maryland 21244; by calling (410) 786–4132 or (877) 267–2323 (toll free); or emailing
PartDPolicy@cms.hhs.gov.
We received no comments on these proposals and therefore are finalizing the
incorporation by reference provisions with typographical and technical changes to § 423.160(c).
The following standards are already approved for the sections in which they appear in the
amendatory text of this rule: NCPDP SCRIPT Standard, Implementation Guide Version 2017071
and NCPDP Formulary and Benefit Standard, Implementation Guide, Version 3, Release 0
(Version 3.0).
12. Summary of Standards for Electronic Prescribing Proposals
We received a few general comments that were not specific to any of the particular
proposals. A discussion of the comments received, along with our responses, follows.
Comment: A few commenters suggested that HHS should require payers outside Part D
to use the same standards required in Part D.
Response: We thank commenters for their suggestions acknowledging the role of CMS in
advancing the adoption of updated standards through our requirements for Part D. We appreciate
the fact that commenters believe that the standards required for electronic prescribing in Part D
would provide value to electronic prescribing processes in other areas.

Comment: A commenter indicated that CMS should monitor the implementation progress
of the required standards to assure there are no disruptions in care during the transition to, or as a
result of, the implementation of the new versions of the standards.
Response: CMS monitors complaints received and will investigate complaints that
suggest that required standards are not implemented appropriately.
In consideration of the public comments received and the discussion in sections II.A.4.
though II.A.11. of this rule, we are finalizing all of the following:
● Requiring in § 423.160(b)(1) that Part D sponsors, prescribers, and dispensers of Part D
drugs for Part D eligible individuals comply with a standard in 45 CFR 170.205(b) for
communication of a prescription or prescription-related information. Under paragraph 45 CFR
170.205(b), ONC is adopting NCPDP SCRIPT standard version 2023011 in 45 CFR
170.205(b)(2) and finalizing an expiration date of January 1, 2028 for NCPDP SCRIPT standard
version 2017071 in 45 CFR 170.205(b)(1). A transition period will begin on the effective date of
the final rule, when either version of the NCPDP SCRIPT standard may be used. The transition
period will end on December 31, 2027 because as of January 1, 2028, NCPDP SCRIPT standard
version 2017071 will expire for the purposes of HHS use, as described in section II.B.8.a. of this
rule. Starting January 1, 2028, NCPDP SCRIPT standard version 2023011 will be the only
version of the NCPDP SCRIPT standard available for HHS use and for purposes of the Medicare
Part D electronic prescribing program.
● Requiring in § 423.160(b)(5), beginning January 1, 2027, prescriber RTBTs
implemented by Part D sponsors to comply with a standard in 45 CFR 170.205(c), where ONC is
adopting NCPDP RTPB standard version 13, as described in section II.B.8.b. of this rule.
● Requiring in § 423.160(b)(3), beginning January 1, 2027, transmission of formulary
and benefit information between prescribers and Medicare Part D sponsors to comply with a
standard in 45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60, and
retiring use of NCPDP F&B standard version 3.0 for transmitting formulary and benefit

information between prescribers and Part D sponsors. This requirement includes a transition
period beginning on the effective date of the final rule, and ending December 31, 2026, where
entities will be permitted to use either NCPDP F&B standard version 3.0 (named at
§ 423.160(b)(3) consistent with the technical changes in this rule) or NCPDP F&B standard
version 60, adopted at 45 CFR 170.205(u). Starting January 1, 2027, only a version of the
NCPDP F&B standard adopted for HHS use at 45 CFR 170.205(u) will be permitted for use in
Part D electronic prescription drug program, which will be NCPDP F&B standard version 60 as
discussed in section II.B.8.c. of this rule.
● Cross-referencing in § 423.160(b)(2) standards adopted for eligibility transactions in
HIPAA regulations at 45 CFR 162.1202 for requirements related to eligibility inquiries and
responses.
● Making multiple technical changes to the regulation text throughout § 423.160 for
clarity by removing requirements and incorporations by reference that are no longer applicable
or redundant, reorganizing existing requirements, and correcting a technical error.
● Incorporating by reference NCPDP SCRIPT Standard, Implementation Guide Version
2023011 at § 423.160(c)(3); NCPDP Real-Time Prescription Benefit Standard, Implementation
Guide Version 13 at § 423.160(c)(4); and NCPDP Formulary and Benefit Standard,
Implementation Guide Version 60, at § 423.160(c)(5).
B. Adoption of Health IT Standards and Incorporation by Reference (45 CFR 170.205 and
170.299)
1. Overview
In this section, ONC proposed to adopt standards for electronic prescribing and related
activities on behalf of HHS under the authority in section 3004 of the Public Health Service Act
(42 U.S.C. 300jj-14). ONC proposed these standards for adoption by HHS as part of a
nationwide health information technology infrastructure that supports reducing burden and health
care costs and improving patient care. ONC proposed to adopt these standards on behalf of HHS

in one location within the Code of Federal Regulations for HHS use, including by the Part D
Program as proposed in section II.A. of this final rule. These proposals reflected a unified
approach across the Department to adopt standards for electronic prescribing (e-prescribing)
activities that have previously been adopted separately by CMS and ONC under independent
authorities. This approach is intended to increase alignment across HHS and reduce regulatory
burden for interested parties subject to program requirements that incorporate these standards.
In the Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program,
Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and
Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and
Implementation Specifications” (hereinafter referred to as the “December 2022 proposed rule”),
which appeared in the Federal Register on December 27, 2022 (87 FR 79552 through 79557),
we proposed to adopt NCPDP SCRIPT standard version 2022011 and NCPDP Real-Time
Prescription Benefit (RTPB) standard version 12, as well as related proposals. As discussed in
the November 2023 proposed rule, we withdrew the proposals in sections III.T. and III.U. of the
December 2022 proposed rule (87 FR 79552 through 79557). We issued a series of new
proposals in the November 2023 proposed rule that took into consideration the feedback we
received from commenters on the December 2022 proposed rule and further built on these
proposals (88 FR 78499 through 78503). Additionally, summaries of the standards we proposed
to adopt and subsequently incorporate by reference in the Code of Federal Regulations can be
found below in section II.B.10. of this rule.
2. Statutory Authority
The Health Information Technology for Economic and Clinical Health Act (HITECH
Act), Title XIII of Division A and Title IV of Division B of the American Recovery and
Reinvestment Act of 2009 (Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act
amended the Public Health Service Act (PHSA) and created “Title XXX—Health Information

Technology and Quality” (Title XXX) to improve health care quality, safety, and efficiency
through the promotion of health IT and exchange of electronic health information (EHI).
Subsequently, Title IV of the 21st Century Cures Act (Pub. L. 114-255) (hereinafter referred to
as the “Cures Act”) amended portions of the HITECH Act by modifying or adding certain
provisions to the PHSA relating to health IT.
3. Adoption of Standards and Implementation Specifications
Section 3001 of the PHSA directs the National Coordinator for Health Information
Technology (National Coordinator) to perform duties in a manner consistent with the
development of a nationwide health information technology infrastructure that allows for the
electronic use and exchange of information. Section 3001(b) of the PHSA establishes a series of
core goals for development of a nationwide health information technology infrastructure that-● Ensures that each patient's health information is secure and protected, in accordance
with applicable law;
● Improves health care quality, reduces medical errors, reduces health disparities, and
advances the delivery of patient-centered medical care;
● Reduces health care costs resulting from inefficiency, medical errors, inappropriate
care, duplicative care, and incomplete information;
● Provides appropriate information to help guide medical decisions at the time and place
of care;
● Ensures the inclusion of meaningful public input in such development of such
infrastructure;
● Improves the coordination of care and information among hospitals, laboratories,
physician offices, and other entities through an effective infrastructure for the secure and
authorized exchange of health care information;

● Improves public health activities and facilitates the early identification and rapid
response to public health threats and emergencies, including bioterror events and infectious
disease outbreaks;
● Facilitates health and clinical research and health care quality;
● Promotes early detection, prevention, and management of chronic diseases;
● Promotes a more effective marketplace, greater competition, greater systems analysis,
increased consumer choice, and improved outcomes in health care services; and
● Improves efforts to reduce health disparities.
Section 3004 of the PHSA identifies a process for the adoption of health IT standards,
implementation specifications, and certification criteria, and authorizes the Secretary to adopt
such standards, implementation specifications, and certification criteria. As specified in section
3004(a)(1) of the PHSA, the Secretary is required, in consultation with representatives of other
relevant Federal agencies, to jointly review standards, implementation specifications, and
certification criteria endorsed by the National Coordinator under section 3001(c) of the PHSA
and subsequently determine whether to propose the adoption of any grouping of such standards,
implementation specifications, or certification criteria. The Secretary is required to publish all
determinations in the Federal Register.
Section 3004(b)(3) of the PHSA, which is titled “Subsequent Standards Activity,”
provides that the Secretary shall adopt additional standards, implementation specifications, and
certification criteria as necessary and consistent with the schedule published by the Health IT
Advisory Committee (hereinafter referred to as the “HITAC”). As noted in the final rule, “2015
Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base
Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program
Modifications,” which appeared in the October 16, 2015 Federal Register, we consider this
provision in the broader context of the HITECH Act and the Cures Act to grant the Secretary the
authority and discretion to adopt standards, implementation specifications, and certification

criteria that have been recommended by the HITAC and endorsed by the National Coordinator,
as well as other appropriate and necessary health IT standards, implementation specifications,
and certification criteria (80 FR 62606).
Under the authority outlined in section 3004(b)(3) of the PHSA, the Secretary may adopt
standards, implementation specifications, and certification criteria as necessary even if those
standards have not been recommended and endorsed through the process established for the
HITAC under section 3002(b)(2) and (3) of the PHSA. Moreover, while HHS has traditionally
adopted standards and implementation specifications at the same time as adopting certification
criteria that reference those standards, the Secretary's authority under section 3004(b)(3) of the
PHSA is not limited to adopting standards or implementation specifications at the same time
certification criteria are adopted.
Finally, the Cures Act amended the PHSA by adding section 3004(c), which specifies
that in adopting and implementing standards under section 3004, the Secretary shall give
deference to standards published by standards development organizations and voluntary
consensus-based standards bodies.
4. Alignment with Federal Advisory Committee Activities
The HITECH Act established two Federal advisory committees, the HIT Policy
Committee (hereinafter referred to as the “HITPC”) and the HIT Standards Committee
(hereinafter referred to as the “HITSC”). Each was responsible for advising the National
Coordinator on different aspects of health IT policy, standards, implementation specifications,
and certification criteria.
Section 4003(e) of the Cures Act amended section 3002 of the PHSA and replaced the
HITPC and HITSC with one committee, the HITAC. After that change, section 3002(a) of the
PHSA establishes that the HITAC advises and recommends to the National Coordinator
standards, implementation specifications, and certification criteria relating to the implementation
of a health IT infrastructure, nationally and locally, that advances the electronic access,

exchange, and use of health information. The Cures Act specifically directed the HITAC to
advise on two areas: (1) a policy framework to advance an interoperable health information
technology infrastructure (section 3002(b)(1) of the PHSA); and (2) priority target areas for
standards, implementation specifications, and certification criteria (section 3002(b)(2) of the
PHSA).
For the policy framework, as described in section 3002(b)(1)(A) of the PHSA, the Cures
Act tasked the HITAC with providing recommendations to the National Coordinator on a policy
framework for adoption by the Secretary consistent with the Federal Health IT Strategic Plan
under section 3001(c)(3) of the PHSA. In February of 2018, the HITAC made recommendations
to the National Coordinator for the initial policy framework40 and subsequently published a
schedule in the Federal Register and an annual report on the work of the HITAC and ONC to
implement and evolve that framework.41 For the priority target areas for standards,
implementation specifications, and certification criteria, section 3002(b)(2)(A) of the PHSA
identified that in general, the HITAC would recommend to the National Coordinator, for
purposes of adoption under section 3004 of the PHSA, standards, implementation specifications,
and certification criteria and an order of priority for the development, harmonization, and
recognition of such standards, specifications, and certification criteria. In October of 2019, the
HITAC finalized recommendations on priority target areas for standards, implementation
specifications, and certification criteria.42
5. Aligned Approach to Standards Adoption
Historically, the ONC Health IT Certification Program and the Part D Program have
maintained complementary policies of aligning health IT certification criteria and associated

HITAC Policy Framework Recommendations, February 21, 2018:
https://www.healthit.gov/sites/default/files/page/2019-07/2018-02-21_HITAC_Policy-Framework_FINAL_508signed.pdf.
41 Health Information Technology Advisory Committee (HITAC) Annual Report for Fiscal Year 2019 published
March 2, 2020: https://www.healthit.gov/sites/default/files/page/202003/HITAC%20Annual%20Report%20for%20FY19_508.pdf.
42 HITAC recommendations on priority target areas, October 16, 2019:
https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf.
standards related to electronic prescribing, medication history, and electronic prior authorization
for prescriptions. While CMS and ONC have worked closely together to ensure consistent
adoption of standards through regulatory actions, we recognize that the practice of different HHS
components conducting parallel adoption of the same standards may result in additional
regulatory burden and confusion for interested parties. For instance, due to discrepancies
between regulatory timelines, adoption of the NCPDP SCRIPT standard version 2017071 in
different rules (respectively, the ONC Cures Act final rule (85 FR 25642); and the Medicare
Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage,
Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit
Programs, and the PACE Program final rule, which appeared in the April 16, 2018 Federal
Register (83 FR 16440)) led to a period where ONC had to exercise special enforcement
discretion in the ONC Health IT Certification Program.43 Given these concerns, ONC and CMS
proposals in the December 2022 proposed rule (87 FR 79552 through 79557) reflected a new
approach to alignment of standards under which ONC proposed to adopt, on behalf of HHS, the
NCPDP SCRIPT standard version 2022011 and the NCPDP RTPB standard version 12 in a
single Code of Federal Regulations location at 45 CFR 170.205, where CMS proposed to crossreference these standards for requirements in the Part D program.
Additional discussion of this approach can be found in the December 2022 proposed rule
(87 FR 79552 through 79557) and CMS’s discussion in sections II.A.3. through II.A.7. of this
final rule. We note that this rule also reflects an aligned approach with CMS to adoption of
health IT standards for e-prescribing and related purposes. We believe our adoption of these
standards in a single CFR location for HHS use will help to address concerns around alignment
across HHS programs.

See the archived version of the Certification Companion Guide for the ‘‘electronic prescribing’’ certification
criterion in 45 CFR 170.315(b)(3): https://www.healthit.gov/sites/default/files/page/2020-12/b3_ccg.pdf.
Comment: Commenters supported the approach reflected in our proposed adoption of
standards and alignment within a single CFR location, which they stated would reduce burden
and cost, improve care, and improve coordination.
Response: We thank commenters for their support.
6. Regulatory History
For a summary of past standards adoption activities under section 3004 of the PHSA
intended to ensure alignment for electronic prescribing and related activities across the ONC
Health IT Certification Program and the Part D Program, we refer readers to the December 2022
proposed rule (87 FR 79553). For a summary of previous notice-and-comment rulemaking
related to formulary and benefit management capabilities in the ONC Health IT Certification
Program, we refer readers to the “Health Data, Technology, and Interoperability: Certification
Program Updates, Algorithm Transparency, and Information Sharing” proposed rule (hereinafter
referred to as the “HTI-1 Proposed Rule”) (88 FR 23853 through 23854).
7. Interoperability Standards Advisory
ONC's Interoperability Standards Advisory (ISA) supports the identification, assessment,
and public awareness of interoperability standards and implementation specifications that can be
used by the health care industry to address specific interoperability needs.44 The ISA is updated
on an annual basis based on recommendations received from public comments and subject
matter expert feedback. This public comment process reflects ongoing dialogue, debate, and
consensus among industry interested parties when more than one standard or implementation
specification could be used to address a specific interoperability need.
ONC currently identifies the standards adopted in this section within the ISA as available
standards for a variety of potential use cases. The NCPDP SCRIPT standard version 2023011,
the NCPDP RTPB standard version 13, and the NCPDP Formulary and Benefit (F&B) standard
version 60 are currently identified in sections of the ISA including the “Pharmacy

See https://www.healthit.gov/isa.

Interoperability”45 and “Administrative Transactions—Non-Claims.”46 We encourage interested
parties to review the ISA to better understand key applications for the implementation
specifications proposed for adoption in this rule.
8. Proposal to Adopt Standards for Use by HHS
Consistent with section 3004(b)(3) of the PHSA and the efforts, as previously described,
to evaluate and identify standards for adoption, we proposed to adopt the following standards in
45 CFR 170.205(b)(2), (c)(1), and (u)(1), on behalf of the Secretary, to support the continued
development of a nationwide health information technology infrastructure as described under
section 3001(b) of the PHSA, and to support Federal alignment of standards for interoperability
and health information exchange. Specifically, we proposed to adopt the following standards:
● NCPDP SCRIPT Standard, Implementation Guide, Version 2023011.
● NCPDP Real-Time Prescription Benefit (RTPB) Standard, Implementation Guide,
Version 13.
● NCPDP Formulary and Benefit (F&B) Standard, Implementation Guide, Version 60.
In addition to comments on the individual proposals below, we also invited comments on
whether there are alternative versions, including any newer versions, of these or other standards
that we should consider for adoption for HHS use. In particular, we stated we were interested in,
and would consider for adoption in a final rule, any newer version of the proposed standard(s)
that may correct any unidentified errors or clarify ambiguities that would support successful
implementation of the standard(s) and the interoperability of health IT.
a. NCPDP SCRIPT Standard Version 2023011 (45 CFR 170.205(b)(2))
ONC has previously adopted three versions of the NCPDP SCRIPT standard in 45 CFR
170.205. Most recently, we adopted NCPDP SCRIPT standard version 2017071 in the ONC

45
See https://www.healthit.gov/isa/section/pharmacyinteroperability.
See https://www.healthit.gov/isa/section/administrative-transactions-non-claims.

Cures Act final rule to facilitate the transfer of prescription data among pharmacies, prescribers,
and payers (85 FR 25678).
The updated NCPDP SCRIPT standard version 2023011 includes important
enhancements relative to NCPDP SCRIPT standard version 2017071. Enhancements have been
added to support electronic prior authorization functions as well as electronic transfer of
prescriptions between pharmacies. NCPDP SCRIPT standard version 2023011 also includes
functionality that supports a 3-way transaction among prescriber, facility, and pharmacy, which
will enable electronic prescribing of controlled substances in the long-term care (LTC) setting.47
We proposed to adopt NCPDP SCRIPT standard version 2023011 in 45 CFR
170.205(b)(2), replacing NCPDP SCRIPT standard version 10.6 which is currently in
170.205(b)(2). We proposed to incorporate NCPDP SCRIPT standard version 2023011 by
reference in 45 CFR 170.299. Regarding NCPDP SCRIPT standard version 2017071, we
proposed to revise the regulatory text in 45 CFR 170.205(b)(1) to specify that adoption of this
standard will expire on January 1, 2027. We stated that if these proposals were finalized, this
would mean that both the 2017071 and 2023011 versions of the NCPDP SCRIPT standard would
be available for HHS use from the effective date of a final rule until January 1, 2027. On and
after January 1, 2027, we stated that only the 2023011 version of the NCPDP SCRIPT standard
would be available for HHS use, for instance, where use of a standard in 45 CFR 170.205(b) is
required. We refer readers to section II.A.4. of this final rule, where CMS discusses its proposal
at § 423.160(b)(1) to require use of a standard in 45 CFR 170.205(b) for communication of a
prescription or prescription-related information to fulfill requirements for prescriptions,
electronic prior authorization, and medication history.
We requested comment on these proposals and received several comments. A discussion
of these comments, along with our responses follows.

See
https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.
pdf.
Comment: Commenters supported the proposed adoption of the NCPDP SCRIPT
standard version 2023011, stating that it would improve patient safety, avoid mistakes and errors,
and improve information-sharing. Commenters noted that the NCPDP SCRIPT standard version
2023011 includes important enhancements to support the electronic transfer of prescriptions
between pharmacies.
Response: We thank commenters for their support.
Comment: Some commenters agreed with January 1, 2027 as the proposed date by which
NCPDP SCRIPT standard version 2023011 would be the only available version of the NCPDP
SCRIPT standard for use, due to the proposed expiration of NCPDP SCRIPT standard version
2017071 on that date, while other commenters suggested that we delay the date to January 1,
2028. A few commenters noted that January 1 (the start of the year) can also be difficult with end
of year work and suggested a middle of the year date instead.
Response: We recognize that, as a result of CMS finalizing their proposals in section
II.A.4. of this final rule, which cross-reference our standards adoption proposals in this section,
Part D sponsors will need to make a series of changes to different systems in order to ensure
compliance with the required standards. Taking into consideration comments on Part D
requirements related to the other standards we have proposed for adoption, we agree with CMS
that a staggered approach to these updates will allow Part D sponsors to ensure successful
adoption and implementation.
Thus, we are modifying our proposal in 45 CFR 170.205(b)(1) for the expiration of
NCPDP SCRIPT standard version 2017071 from January 1, 2027, to instead be January 1, 2028.
As a result of this modified final policy, the requirements for Part D sponsors finalized in section
II.A.4. of this final rule, which cross-reference the standards in 45 CFR 170.205(b), will allow
for an additional transitional year before Part D sponsors must only use NCPDP SCRIPT
standard version 2023011.

We disagree with commenters that a middle of the year date should be used as a
compliance date, as January 1 follows many other CMS and ONC program compliance dates,
and we believe it is important to maintain consistency in our alignment with these programs. As
discussed in the November 2023 proposed rule (88 FR 78498), our proposed expiration date for
the NCPDP SCRIPT standard version 2017071 would allow for a period when a requirement to
use a standard in 45 CFR 170.205(b) would allow for the use of either version of the NCPDP
SCRIPT standard adopted at that location. Thus, implementers including Part D sponsors that
must use a standard in 45 CFR 170.205(b) have flexibility to determine the most appropriate
time to update their systems, until January 1, 2028.
After consideration of the public comments we received, we are finalizing our proposal to
adopt NCPDP SCRIPT standard version 2023011 in 45 CFR 170.205(b)(2) and incorporate it by
reference in 45 CFR 170.299. We are modifying our proposal to revise the regulatory text in 45
CFR 170.205(b)(1) with respect to the proposed expiration date for NCPDP SCRIPT standard
version 2017071 and finalizing that this standard will expire on January 1, 2028. After this date,
only NCPDP SCRIPT standard version 2023011 will be available for HHS use. We refer readers
to section II.A. of this final rule for additional information where CMS discusses its final policies
at § 423.160(b)(1) to require use of a standard in 45 CFR 170.205(b) for communication of a
prescription or prescription-related information to fulfill the requirements for prescriptions,
electronic prior authorization, and medication history.
b. NCPDP Real-Time Prescription Benefit (RTPB) Standard Version 13 (45 CFR 170.205(c)(1))
The NCPDP RTPB standard version 13 enables the exchange of coverage status and
estimated patient financial responsibility for a submitted product and pharmacy and identifies
coverage restrictions and alternatives when they exist. See section II.A.5. of this final rule for a
description of NCPDP RTPB standard functionality and enhancements of NCPDP RTPB
standard version 13 relative to NCPDP RTPB standard version 12.

In the November 2023 proposed rule, we noted that our proposal to adopt this standard
supports the requirements of Division CC, Title I, Subtitle B, section 119 of the Consolidated
Appropriations Act, 2021 (CAA), Pub. L. 116-260, which required sponsors of Medicare
prescription drug plans to implement a real-time benefit tool (RTBT) that meets technical
standards named by the Secretary, in consultation with ONC. In addition, section 119(b) of the
CAA amended the definition of a “qualified electronic health record” in section 3000(13) of the
PHSA to specify that a “qualified electronic health record” must include or be capable of
including a RTBT. We stated that ONC intends to address this provision in future rulemaking for
the ONC Health IT Certification Program and would ensure alignment with the proposed
NCPDP RTPB standard version 13, if finalized, and related proposals in the Part D program
where appropriate.
We also noted that the HITAC had previously addressed real-time prescription benefit
standards, consistent with its statutory role to recommend standards. In 2019, the HITAC
accepted the recommendations included in the 2018 report of the Interoperability Priorities Task
Force, including recommendations to continue to monitor standards then being developed for
real-time prescription benefit transactions, and, when the standards are sufficiently validated, to
require EHR vendors to provide functionality that integrates real time patient-specific
prescription benefit checking into the prescribing workflow.48 In early 2020, the National
Committee on Vital and Health Statistics (NCVHS) and HITAC convened another task force, the
Intersection of Clinical and Administrative Data (ICAD) Task Force, which was charged with
convening industry experts and producing recommendations related to electronic prior
authorizations. The task force report was presented to HITAC in November 202049 and discussed
the NCPDP RTPB standard as an important tool for addressing administrative transactions
around prescribing.

See https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf.
See https://www.healthit.gov/sites/default/files/page/2020-11/2020-11-17_ICAD_TF_FINAL_Report_
HITAC.pdf.
48
We proposed in 45 CFR 170.205(c) to add a new section heading for “Real-time
prescription benefit.” We also proposed to adopt the NCPDP RTPB standard version 1350 in 45
CFR 170.205(c)(1) and to incorporate this standard by reference in 45 CFR 170.299. We referred
readers to section III.B.5. of the November 2023 proposed rule, where CMS proposed at 42
CFR 423.160(b)(5) to require Part D sponsors’ RTBTs to comply with a standard in 45 CFR
170.205(c) by January 1, 2027, to fulfill the requirements for real-time benefit tools. As
previously noted, we stated that ONC would consider proposals to require use of this standard to
support RTBT functionality in the ONC Health IT Certification Program, consistent with section
119 of the CAA, in future rulemaking.
We requested comment on these proposals and received several comments. A discussion
of these comments, along with our responses follows.
Comment: Commenters supported our proposal to adopt the NCPDP RTPB standard
version 13, noting that use of this standard is necessary to provide clinicians and patients with
transparency about coverage requirements and cost information for informed decision making.
Response: We thank commenters for their support.
After consideration of the public comments received, we are finalizing our proposal to
add a new section heading at 45 CFR 170.205(c), “Real-time prescription benefit.” We are also
finalizing our proposal to adopt the NCPDP RTPB standard version 1351 in 45 CFR
170.205(c)(1) and incorporate it by reference in 45 CFR 170.299. We refer readers to section
II.A. of this rule for additional information on CMS’s finalized policy at § 423.160(b)(5) to
require Part D sponsors’ RTBTs to comply with a standard in 45 CFR 170.205(c) by January 1,
2027, to fulfill the requirements for real-time benefit tools.

50
See https://standards.ncpdp.org/Access-to-Standards.aspx.
See https://standards.ncpdp.org/Access-to-Standards.aspx.

c. NCPDP Formulary and Benefit (F&B) Standard Version 60 (45 CFR 170.205(u))
The NCPDP F&B standard version 6052 provides a uniform means for prescription drug
plan sponsors to communicate plan-level formulary and benefit information to prescribers
through electronic prescribing/EHR systems. The NCPDP F&B standard transmits, on a batch
basis, data on the formulary status of drugs, preferred alternatives, coverage restrictions (that is,
utilization management requirements), and cost sharing consistent with the benefit design (for
example, cost sharing for drugs on a particular tier). The NCPDP F&B standard serves as a
foundation for other electronic prescribing transactions including ePA, real-time benefit check,
and specialty medication eligibility when used in conjunction with other standards.
We proposed to add a new paragraph heading at 45 CFR 170.205(u), “Formulary and
benefit.” We proposed to adopt the NCPDP F&B standard version 60 at 45 CFR 170.205(u)(1)
and to incorporate this standard by reference in 45 CFR 170.299. We referred readers to section
III.B.6. of the November 2023 proposed rule, where CMS proposed at § 423.160(b)(3) to require,
by January 1, 2027, use of a standard in 45 CFR 170.205(u) by Part D sponsors to fulfill the
requirements for exchange of formulary and benefit information with prescribers.
We requested comment on these proposals and received several comments. A discussion
of these comments, along with our responses, follows.
Comment: Commenters supported the adoption of the NCPDP F&B standard version 60,
noting that this standard provides numerous enhancements and a uniformed means for
prescription drug plan sponsors to communicate plan-level formulary and benefit information to
prescribers through prescribing/EHR systems on a batch basis.
Response: We thank commenters for their support.
After consideration of the public comments we received, we are finalizing our proposal to
add a new paragraph heading at 45 CFR 170.205(u), “Formulary and benefit.” We are also
finalizing our proposal to adopt the NCPDP F&B standard version 60 at 45 CFR 170.205(u)(1)

See https://standards.ncpdp.org/Access-to-Standards.aspx.

and to incorporate this standard by reference in 45 CFR 170.299. We refer readers to section
II.A. of this rule for additional information on policies CMS is finalizing at 42
CFR 423.160(b)(3) to require, by January 1, 2027, use of a standard in 45 CFR 170.205(u) for
transmitting formulary and benefit information between prescribers and Medicare Part D
sponsors.
9. ONC Health IT Certification Program
In the November 2023 proposed rule, we did not propose new or revised certification
criteria based on the proposed adoption of standards in the proposed rule. We noted that section
119 of the CAA does not require ONC to adopt certification criteria for real-time prescription
benefit capabilities at the same time as a standard is adopted by HHS. We therefore proposed to
adopt the NCPDP Real-Time Prescription Benefit standard for HHS use and as previously
discussed, stated that ONC would address new or revised certification criteria referencing the
standard, if finalized, in separate rulemaking. We noted that ONC published a Request for
Information in the HTI-1 Proposed Rule seeking information related to potential establishment of
a “real-time prescription benefit” criterion (88 FR 23853 through 23854). We also noted that
ONC would continue to collaborate with CMS to ensure that any future proposals in the ONC
Health IT Certification Program continue to advance alignment with program requirements
under the Part D Program.
We believe the approach reflected in the standards we have adopted in this final rule will
support Federal alignment and coordination of Federal activities with adopted standards and
implementation specifications for a wide range of systems, use cases, and data types within the
broad scope of health information exchange. Historically, State, Federal, and local partners have
leveraged the standards adopted by ONC on behalf of HHS to inform program requirements,
technical requirements for grants and funding opportunities, and systems implementation for
health information exchange. We believe the adoption of these standards will support HHS

partners in setting technical requirements and advancing the use of innovative health IT solutions
for electronic prescribing and related activities.
10. Incorporation by Reference (45 CFR 170.299)
The Office of the Federal Register has established requirements for materials (for
example, standards and implementation specifications) that agencies incorporate by reference in
the Code of Federal Regulations (79 FR 66267; 1 CFR 51.5(a)). Specifically, 1 CFR 51.5(a)
requires agencies to discuss, in the preamble of a final rule, the ways that the materials they
incorporate by reference are reasonably available to interested parties or how they worked to
make those materials reasonably available to interested parties; and summarize, in the preamble
of the final rule, the material they incorporate by reference.
To make the materials reasonably available, we provide a uniform resource locator
(URL) for the standards and implementation specifications. In many cases, these standards and
implementation specifications are directly accessible through the URLs provided. In instances
where they are not directly available, we note the steps and requirements necessary to gain
access to the standard or implementation specification. In most of these instances, access to the
standard or implementation specification can be gained through no-cost (monetary) participation,
subscription, or membership with the applicable standards developing organization (SDO) or
custodial organization. In certain instances, where noted, access requires a fee or paid
membership. As an alternative, a copy of the standards may be viewed for free at the U.S.
Department of Health and Human Services, Office of the National Coordinator for Health
Information Technology, 330 C Street SW, Washington, DC 20201. Please call (202) 690-7171
in advance to arrange inspection.
The National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C.
3701 et seq.) and the Office of Management and Budget (OMB) Circular A-119 require the use
of, wherever practical, technical standards that are developed or adopted by voluntary consensus
standards bodies to carry out policy objectives or activities, with certain exceptions. The NTTAA

and OMB Circular A-119 provide exceptions to selecting only standards developed or adopted
by voluntary consensus standards bodies, namely when doing so would be inconsistent with
applicable law or otherwise impractical. We have followed the NTTAA and OMB Circular A119 in adopting standards and implementation specifications and note that the technical
standards adopted in 45 CFR 170.205 in this final rule were developed by NCPDP, which is an
ANSI-accredited, not-for-profit membership organization using a consensus-based process for
standards development.
As required by 1 CFR 51.5(a), we provide summaries of the standards we have adopted
and incorporate by reference in the Code of Federal Regulations. We also provide relevant
information about these standards and implementation specifications in the preamble where these
standards are adopted. We are finalizing revisions to § 170.299(k) with the following standards
as well as typographical and technical revisions:
● NCPDP SCRIPT Standard, Implementation Guide, Version 2023011, (Approval Date
for ANSI: January 17, 2023)
URL: https://standards.ncpdp.org/Access-to-Standards.aspx.
Access requires registration, a membership fee, a user account, and a license agreement to obtain
a copy of the standard.
Summary: SCRIPT is a standard created to facilitate the transfer of prescription data
between pharmacies, prescribers, and payers. The current standard supports transactions
regarding new prescriptions, prescription changes, renewal requests, prescription fill status
notification, and prescription cancellation. Enhancements have been added for drug utilization
review/use (DUR/DUE) alerts and formulary information as well as transactions to relay
medication history and for a facility to notify a pharmacy of resident information. Enhancements
have been added to support electronic prior authorization functions as well as electronic transfer
of prescriptions between pharmacies.

● NCPDP Real-Time Prescription Benefit Standard, Implementation Guide, Version 13,
(Approval Date for ANSI: May 19, 2022)
URL: https://standards.ncpdp.org/Access-to-Standards.aspx.
Access requires registration, a membership fee, a user account, and a license agreement
to obtain a copy of the standard.
Summary: The NCPDP Real-Time Prescription Benefit Standard Implementation Guide
is intended to meet the industry need within the pharmacy services sector to facilitate the ability
for pharmacy benefit payers/processors to communicate to providers and to ensure a consistent
implementation of the standard throughout the industry. The NCPDP Real-Time Prescription
Benefit standard enables the exchange of patient eligibility, product coverage, and benefit
financials for a chosen product and pharmacy, and identifies coverage restrictions, and
alternatives when they exist.
● NCPDP Formulary and Benefit Standard, Implementation Guide, Version 60,
(Approval Date for ANSI: April 12, 2023)
URL: https://standards.ncpdp.org/Access-to-Standards.aspx
Access requires registration, a membership fee, a user account, and a license agreement
to obtain a copy of the standard.
Summary: This NCPDP Formulary and Benefit Standard Implementation Guide is
intended to provide a standard means for pharmacy benefit payers (including health plans and
pharmacy benefit managers) to communicate formulary and benefit information to prescribers
via technology vendor systems.
The following standard is already approved for the section in which it appears in the
amendatory text of this rule: NCPDP SCRIPT Standard, Implementation Guide Version
2017071.
III. Collection of Information Requirements
A. Background

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are
required to provide 60-day notice in the Federal Register and solicit public comment before a
“collection of information,” as defined under 5 CFR 1320.3(c) of the PRA’s implementing
regulations, is submitted to the Office of Management and Budget (OMB) for review and
approval. To fairly evaluate whether an information collection requirement (ICR) should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the
following issues:
● The need for the information collection and its usefulness in carrying out the proper
functions of our agency.
● The accuracy of our estimate of the information collection burden.
● The quality, utility, and clarity of the information to be collected.
● Recommendations to minimize the information collection burden on the affected
public, including automated collection techniques.
In our December 2022 (CMS-4201-P; RIN 0938-AU96; 87 FR 79452) and November
2023 (CMS-4205-P; RIN 0938-AV24; 88 FR 78476) proposed rules, we solicited public
comment on each of the aforementioned issues for the following information collection
requirements.
B. ICRs Regarding Standards for Electronic Prescribing (42 CFR 423.160 and 45 CFR 170.205
and 170.299)
In sections II.A. and II.B. of this final rule, we discuss proposals, which we are finalizing
in this rule, to update the standards to be used for electronic transmission of prescriptions and
prescription-related information for Part D covered drugs for Part D eligible individuals. This
includes: (1) adopting the National Council for Prescription Drug Plans (NCPDP) SCRIPT
standard version 2023011 at 45 CFR 170.205(b)(2), and, after a transition period, retiring use of
NCPDP SCRIPT standard version 2017071 for communication of a prescription or prescriptionrelated information supported by Part D sponsors; (2) requiring use of NCPDP RTPB standard

version 13 for prescriber RTBTs implemented by Part D sponsors; and (3) requiring use of
NCPDP Formulary and Benefit (F&B) standard version 60, at 45 CFR 170.205(u), and retiring
use of NCPDP F&B standard version 3.0 for transmitting formulary and benefit information
between prescribers and Part D sponsors. These proposals update existing standards that are
exempt from the PRA, as explained in this section.
The initial electronic prescribing standards for the Medicare Part D program were
adopted in the final rule “Medicare Program; Standards for E-Prescribing Under Medicare Part D
and Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and
the Medicare Prescription Drug Program (Version 8.1)” (hereinafter referred to as the “Initial
Standards final rule”), which appeared in the April 4, 2008 Federal Register (73 FR 18918).
The Initial Standards final rule implemented the first update to the electronic prescribing
foundation standards in the Part D program that had been adopted in the final rule “Medicare
Program; E-Prescribing and the Prescription Drug Program” (hereinafter referred to as the
“Foundation Standards final rule”), which appeared in the November 7, 2005 Federal Register
(70 FR 67568). The Initial Standards final rule adopted the updated the NCPDP SCRIPT
standard version 8.1 and retired the previous NCPDP SCRIPT standard version 5.0. With respect
to ICRs in the Initial Standards final rule, CMS explained that the burden associated with the
requirement that Part D sponsors must support and comply with the adopted electronic
prescribing standards when prescriptions and prescription-related information is transmitted
electronically for covered Part D drugs, prescribed for Part D eligible individuals is exempt from
the PRA as stipulated under 5 CFR 1320.3(b)(2) because use of standards for electronic
prescribing constitutes a usual and customary business practice (73 FR 18931).
Subsequent rules that have updated electronic prescribing standards in the Medicare Part
D program also considered such practice as exempt from the PRA. Specifically—
● The “Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of

Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY
2013” final rule, which appeared in the November 16, 2012, Federal Register (77 FR 68892).
This final rule updated the electronic prescribing standards in Medicare Part D from NCPDP
SCRIPT standard version 8.1 to version 10.6;
● The “Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014” final
rule, which appeared in the Federal Register on December 10, 2013 (78 FR 74230). This final
rule updated the electronic prescribing standards in Medicare Part D from NCPDP F&B standard
version 1.0 to version 3.0; and
● The “Medicare Program; Contract Year 2019 Policy and Technical Changes to the
Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription
Drug Benefit Programs, and the PACE Program” final rule, which appeared in the Federal
Register on April 16, 2018 (83 FR 16640). This final rule updated the electronic prescribing
standards in Medicare Part D from NCPDP SCRIPT standard version 10.6 to version 2017071.
Once electronic prescribing has been enabled through electronic prescribing systems or
EHRs it is a usual and customary business practice that health IT and EHR vendors will update
the systems regularly in order to meet the business needs of their customers utilizing electronic
prescribing. Updating systems with new versions of electronic prescribing standards is one such
update, and NCPDP SCRIPT is the industry standard for electronic prescribing of drugs covered
under a pharmacy benefit. CMS does not require that pharmacies accept electronic prescriptions,
but pharmacies that do would likewise have their systems updated by their health IT software
providers as a usual and customary business practice to meet their business needs. We believe
the burden associated with using the NCPDP SCRIPT standard version 2023011 will be the same
as using NCPDP SCRIPT standard version 2017071 for transmission of prescription and
prescription-related information. We do not anticipate that updating NCPDP SCRIPT standard
version 2017071 to NCPDP SCRIPT standard version 2023011 will result in costs that are

beyond those associated with usual and customary business practices. CMS does not require
prescribers to utilize formulary and benefit information in the process of electronic prescribing,
but for prescribers who do, we believe the burden associated with using NCPDP F&B standard
version 60 will be the same as using NCPDP F&B standard version 3.0. We do not anticipate
that updating NCPDP F&B standard version 3.0 to NCPDP F&B standard version 60 will result
in costs that are beyond those that are usual and customary business practices. We believe this to
be true for health IT and EHR vendors serving the business needs of their customers and Part D
sponsors who likewise have a business interest in facilitating prescribers’ ability to select
preferred formulary products at the time of prescribing.
Part D sponsors have been required to support RTBTs since January 1, 2021, as finalized
in the “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-ofPocket Expenses” final rule, which appeared in the Federal Register on May 23, 2019 (84 FR
23832). Because Part D sponsors have invested in the hardware, software, and connectivity
necessary to utilize RTBTs, we believe that adopting the NCPDP RTPB standard version 13 will
impose de minimis cost on the industry and that costs will be largely offset by the advantages
and efficiencies associated with interoperability that a standard brings. CMS does not require
prescribers to utilize RTBTs, but for prescribers who do utilize RTBTs, we believe that the
burden associated with using an RTBT that does not use a standard will be the same as using an
RTBT that uses NCPDP RTPB standard version 13.
The operations associated with updates to standards finalized in this rule are analogous to
the operations associated with updates to standards in the prior rules described. Therefore, the
provisions in sections II.A. and II.B. of this rule are exempt from the requirements of the PRA.
We received no comments on the proposed ICR narrative in the December 2022 or
November 2023 proposed rules. Therefore, we are finalizing the ICR narrative as is.
IV. Regulatory Impact Statement

We have examined the impact of this rule as required by Executive Order 12866 on
Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving
Regulation and Regulatory Review (January 18, 2011), Executive Order 14094 entitled
“Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of
available regulatory alternatives and, if regulation is necessary, to select regulatory approaches
that maximize net benefits (including potential economic, environmental, public health and
safety effects, distributive impacts, and equity). Executive Order 14094 entitled “Modernizing
Regulatory Review” (hereinafter, the Modernizing E.O.) amends section 3(f) of Executive Order
12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866
defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having
an annual effect on the economy of $200 million or more in any 1 year, or adversely affect in a
material way the economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, territorial, or tribal governments or
communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or
planned by another agency; (3) materially altering the budgetary impacts of entitlement grants,
user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal
or policy issues for which centralized review would meaningfully further the President’s
priorities or the principles set forth in the Executive Order.
A Regulatory Impact Analysis (RIA) must be prepared for regulatory actions that are
significant under section 3(f)(1). Based on our estimates, OMB’s Office of Information and
Regulatory Affairs (OIRA) has determined this rulemaking is not significant per section 3(f)(1)
as measured by the $200 million or more in any one year threshold, since we calculated no

burden associated with the provisions in this rule. Pursuant to Subtitle E of the Small Business
Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act),
OIRA has also determined that this rule does not meet the criteria set forth in 5 U.S.C. 804(2).
The RFA requires agencies to consider the effect of any provision on small entities and
present alternatives, if necessary, for regulatory relief to those small entities. For purposes of the
RFA, small entities include small businesses, nonprofit organizations, and small governmental
jurisdictions. The entities affected by this final rule include Part D sponsors, prescribers, and
dispensers (that is, pharmacies) that electronically transmit prescriptions or prescription-related
information for Part D drugs for Part D-eligible individuals, directly or through an intermediary.
As indicated in section III.B. of this rule, the information collection requirements for the
provisions in this rule are exempt from the PRA because the requirement to utilize a standard for
electronic prescribing is classified as a usual and customary business practice. Consequently, we
have not calculated burden estimates for entities affected by this final rule, regardless of size. We
are not preparing an analysis for the RFA because we have determined, and the Secretary
certifies, that this final rule will not have a significant economic impact on a substantial number
of small entities.
In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a
significant impact on the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds.
We are not preparing an analysis for section 1102(b) of the Act because we have determined, and
the Secretary certifies, that this final rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies
assess anticipated costs and benefits before issuing any rule whose mandates require spending in

any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that
threshold is approximately $183 million. This rule will have no consequential effect on state,
local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it
promulgates a proposed rule (and subsequent final rule) that imposes substantial direct
requirement costs on state and local governments, preempts state law, or otherwise has
Federalism implications. Since this regulation does not impose any costs on state or local
governments, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this final rule was reviewed
by the Office of Management and Budget.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid
Services, approved this document on May 6, 2024.

List of Subjects
42 CFR Part 423
Administrative practice and procedure, Health facilities, Health maintenance
organizations (HMO), Incorporation by reference, Medicare, Penalties, Privacy, Reporting and
recordkeeping requirements.
45 CFR Part 170
Computer technology, Electronic health record, Electronic information system,
Electronic transactions, Health, Healthcare, Health information technology, Health insurance,
Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid, Medicare,
Privacy, Reporting and record keeping requirements, Public health, Security.

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services
amends 42 CFR part 423 and the Department of Health and Human Services amends 45 CFR
part 170 as set forth below:
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
1. The authority citation for part 423 continues to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
2. Section 423.160 is revised to read as follows:
§ 423.160 Standards for electronic prescribing.
(a) General rules. (1) Part D sponsors must establish and maintain an electronic
prescription drug program that complies with the applicable standards in paragraph (b) of this
section when transmitting, directly or through an intermediary, prescriptions and prescriptionrelated information using electronic media for covered Part D drugs for Part D eligible
individuals.
(2) Except as provided in paragraph (a)(3) of this section, prescribers and dispensers that
transmit, directly or through an intermediary, prescriptions and prescription-related information
using electronic media (including entities transmitting prescriptions or prescription-related
information where the prescriber is required by law to issue a prescription for a patient to a nonprescribing provider, such as a nursing facility, that in turn forwards the prescription to a
dispenser), must comply with the applicable standards in paragraph (b) of this section when eprescribing for covered Part D drugs for Part D eligible individuals.
(3)(i) Entities transmitting prescriptions or prescription-related information must utilize
the NCPDP SCRIPT standard, consistent with paragraph (b)(1) of this section, in all instances
other than temporary/transient network transmission failures.
(ii) Electronic transmission of prescriptions or prescription-related information by means
of computer-generated facsimile is only permitted in instances of temporary/transient

transmission failure and communication problems that would preclude the use of the NCPDP
SCRIPT standard adopted by this section.
(iii) Entities may use either HL7 messages or the NCPDP SCRIPT standard to transmit
prescriptions or prescription-related information internally when the sender and the recipient are
part of the same legal entity. If an entity sends prescriptions outside the entity (for example, from
an HMO to a non-HMO pharmacy), it must use the adopted NCPDP SCRIPT standard or other
applicable adopted standards. Any pharmacy within an entity must be able to receive electronic
prescription transmittals for Medicare beneficiaries from outside the entity using the adopted
NCPDP SCRIPT standard. This exemption does not supersede any HIPAA requirement that may
require the use of a HIPAA transaction standard within an organization.
(4) In accordance with section 1860D-4(e)(5) of the Act, the standards under this
paragraph (b) of this section supersede any State law or regulation that—
(i) Is contrary to the standards or restricts the ability to carry out Part D of Title XVIII of
the Act; and
(ii) Pertains to the electronic transmission of medication history and of information on
eligibility, benefits, and prescriptions with respect to covered Part D drugs under Part D of Title
XVIII of the Act.
(5) Beginning on January 1, 2021, prescribers must, except in the circumstances
described in paragraphs (a)(5)(i) through (iii) of this section, conduct prescribing for at least 70
percent of their Schedule II, III, IV, and V controlled substances that are Part D drugs
electronically using the applicable standards in paragraph (b) of this section, subject to the
exemption in paragraph (a)(3)(iii) of this section. Prescriptions written for a beneficiary in a
long-term care facility will not be included in determining compliance until January 1, 2025.
Compliance actions against prescribers who do not meet the compliance threshold based on
prescriptions written for a beneficiary in a long-term care facility will commence on or after
January 1, 2025. Compliance actions against prescribers who do not meet the compliance

threshold based on other prescriptions will commence on or after January 1, 2023. Prescribers
will be exempt from this requirement in the following situations:
(i) Prescriber issues 100 or fewer controlled substance prescriptions for Part D drugs per
calendar year as determined using CMS claims data with dates of service as of December 31st of
the current year.
(ii) Prescriber has an address in PECOS in the geographic area of an emergency or
disaster declared by a Federal, State, or local government entity. If a prescriber does not have an
address in PECOS, prescriber has an address in NPPES in the geographic area of an emergency
or disaster declared by a Federal, State, or local government entity. Starting in the 2024
measurement year, CMS will identify which emergencies or disasters qualify for this exception.
(iii) Prescriber has received a CMS-approved waiver because the prescriber is unable to
conduct electronic prescribing of controlled substances (EPCS) due to circumstances beyond the
prescriber's control.
(b) Standards—(1) Prescriptions, electronic prior authorization, and medication history.
The communication of a prescription or prescription-related information must comply with a
standard in 45 CFR 170.205(b) (incorporated by reference, see paragraph (c) of this section) for
the following transactions, as applicable to the version of the standard in use:
(i)(A) GetMessage.
(B) Status.
(C) Error.
(D) RxChangeRequest and RxChangeResponse.
(E) RxRenewalRequest and RxRenewalResponse.
(F) Resupply.
(G) Verify.
(H) CancelRx and CancelRxResponse.
(I) RxFill.

(J) DrugAdministration.
(K) NewRxRequest.
(L) NewRx.
(M) NewRxResponseDenied.
(N) RxTransferInitiationRequest.
(O) RxTransfer.
(P) RxTransferConfirm.
(Q) RxFillIndicatorChange.
(R) Recertification.
(S) REMSInitiationRequest and REMSInitiationResponse.
(T) REMSRequest and REMSResponse.
(U) RxHistoryRequest and RxHistoryResponse.
(V) PAInitiationRequest and PAInitiationResponse.
(W) PARequest and PAResponse.
(X) PAAppealRequest and PAAppealResponse.
(Y) PACancelRequest and PACancelResponse.
(Z) PANotification.
(ii) [Reserved]
(2) Eligibility. Eligibility inquiries and responses between the Part D sponsor and
prescribers and between the Part D sponsor and dispensers must comply with 45 CFR 162.1202.
(3) Formulary and benefits. The National Council for Prescription Drug Programs
Formulary and Benefits Standard, Implementation Guide, Version 3, Release 0 (Version 3.0),
(incorporated by reference, see paragraph (c)) of this section) or comply with a standard in 45
CFR 170.205(u) (incorporated by reference, see paragraph (c) of this section) for transmitting
formulary and benefits information between prescribers and Part D sponsors. Beginning January
1, 2027, transmission of formulary and benefit information between prescribers and Part D

sponsors must comply with a standard in 45 CFR 170.205(u) (incorporated by reference, see
paragraph (c) of this section).
(4) Provider identifier. The National Provider Identifier (NPI), as defined at 45 CFR
162.406, to identify an individual health care provider to Medicare Part D sponsors, prescribers
and dispensers, in electronically transmitted prescriptions or prescription-related materials for
Medicare Part D covered drugs for Medicare Part D eligible individuals.
(5) Real-time benefit tools. Part D sponsors must implement one or more electronic realtime benefit tools (RTBT) that are capable of integrating with at least one prescriber's ePrescribing (eRx) system or electronic health record (EHR) to provide complete, accurate,
timely, clinically appropriate, patient-specific formulary and benefit information to the prescriber
in real time for assessing coverage under the Part D plan. Such information must include enrollee
cost-sharing information, clinically appropriate formulary alternatives, when available, and the
formulary status of each drug presented including any utilization management requirements
applicable to each alternative drug. Beginning January 1, 2027, Part D sponsors’ RTBT must
comply with a standard in 45 CFR 170.205(c) (incorporated by reference, see paragraph (c) of
this section).
(c) Incorporation by reference. The material listed in this paragraph (c) is incorporated by
reference into this section with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is
available for inspection at the Centers for Medicare & Medicaid Services (CMS) and at the
National Archives and Records Administration (NARA). Contact CMS at: CMS 7500 Security
Boulevard, Baltimore, Maryland 21244; phone: (410) 786-4132 or (877) 267-2323; email:
PartDPolicy@cms.hhs.gov. For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. The
material may be obtained from National Council for Prescription Drug Programs (NCPDP),

Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260–7518; phone: (480) 477–1000;
email: info@ncpdp.org; website: www.ncpdp.org.
(1) NCPDP Formulary and Benefit Standard, Implementation Guide, Version 3, Release
0 (Version 3.0), ANSI-approved January 28, 2011.
(2) NCPDP SCRIPT Standard, Implementation Guide Version 2017071, ANSI-approved
July 28, 2017.
(3) NCPDP SCRIPT Standard, Implementation Guide Version 2023011, ANSI-approved
January 17, 2023.
(4) NCPDP Real-Time Prescription Benefit Standard, Implementation Guide Version 13,
ANSI-approved May 19, 2022.
(5) NCPDP Formulary and Benefit Standard, Implementation Guide Version 60, ANSIapproved April 12, 2023.
Title 45—Public Welfare
PART 170-- HEALTH INFORMATION TECHNOLOGY STANDARDS,
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND
CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY
3. The authority citation for part 170 continues to read as follows:
Authority: 42 U.S.C. 300jj-11; 42 U.S.C 300jj-14; 5 U.S.C. 552.
4. Section 170.205 is amended by—
a. Revising paragraphs (b)(1) and (2).
b. Adding paragraph (c); and
c. Adding paragraph (u).
The revision and additions read as follows:
§ 170.205 Content exchange standards and implementation specifications for exchanging
electronic health information.
*

*

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*

*

(b)

*

*

*

(1) Standard. National Council for Prescription Drug Programs (NCPDP): SCRIPT
Standard Implementation Guide; Version 2017071 (incorporated by reference in § 170.299). The
Secretary's adoption of this standard expires on January 1, 2028.
(2) Standard. NCPDP SCRIPT Standard, Implementation Guide, Version 2023011
(incorporated by reference in § 170.299).
(c) Real-time prescription benefit—(1) Standard. NCPDP Real-Time Prescription
Benefit Standard, Implementation Guide, Version 13 (incorporated by reference in § 170.299).
(2) [Reserved]
*

*

*

*

*

(u) Formulary and benefit—(1) Standard. NCPDP Formulary and Benefit Standard
Version 60 (incorporated by reference in § 170.299).
(2) [Reserved]
*

*

*

*

*

4. Section 170.299 is amended by revising paragraph (k) to read as follows:
§ 170.299 Incorporation by reference.
*

*

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*

(k) National Council for Prescription Drug Programs (NCPDP), Incorporated, 9240 E.
Raintree Drive, Scottsdale, AZ 85260-7518; phone (480) 477-1000; fax: (480) 767-1042:
website: www.ncpdp.org.
(1) NCPDP SCRIPT Standard, Implementation Guide, Version 2017071, ANSI-approved
July 28, 2017; IBR approved for § 170.205(b).
(2) NCPDP SCRIPT Standard, Implementation Guide, Version 2023011, ANSI-approved
January 17, 2023; IBR approved for § 170.205(b).
(3) NCPDP Real-Time Prescription Benefit Standard, Implementation Guide, Version 13,
ANSI-approved May 19, 2022; IBR approved for § 170.205(c).

(4) NCPDP Formulary and Benefit Standard, Implementation Guide, Version 60, ANSIapproved April 12, 2023; IBR approved for § 170.205(u).
*

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Xavier Becerra
Secretary,
Department of Health and Human Services.
[FR Doc. 2024-12842 Filed: 6/13/2024 4:15 pm; Publication Date: 6/17/2024]