[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Rules and Regulations]
[Pages 51238-51265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12842]


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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.

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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 July 17, 2024. The incorporation 
by reference of certain publications listed in the rule is approved by 
the Director of the Federal Register as of July 17, 2024. 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

[[Page 51239]]

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 cross-reference 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 Sec.  423.160.

II. Enhancements to the Medicare Prescription Drug Benefit Program

A. Standards for Electronic Prescribing (Sec.  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 Sec.  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 Sec.  423.160(a)(1), Part D sponsors are required 
to support the Part D e-prescribing program transaction standards as 
part of their electronic prescription drug programs, as described under 
Sec.  423.159(c). Likewise, as specified at Sec.  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 Sec.  
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

[[Page 51240]]

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 Sec.  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 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\
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    \1\ 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.
    \2\ 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.
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    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 Sec.  
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.
     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 
Sec.  423.160(b)(5)(iii) and proposed to be moved to Sec.  
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 Sec.  423.160 by removing requirements and incorporations by 
reference that are no longer applicable, re-organizing 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

[[Page 51241]]

transactions.\3\ As ONC notes in section II.B.5. of this rule, 
independent adoption of the NCPDP SCRIPT standard version 2017071 in 
different rules \4\ 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 cross-reference 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.
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    \3\ 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 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 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).
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    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 Sec.  
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.
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    \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 non-members 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.
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    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-of-
prescribing.6 7 As discussed in section II.A.5. of this 
rule, as currently codified at Sec.  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 Sec.  423.160(b)(5) starting January 1, 2027.
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    \6\ 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 real-time benefit tool. 
Am J Manag Care. 2022 Oct 1;28(10):e363-e369. doi: 10.37765/
ajmc.2022.89254.
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    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.
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    \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):725-730. https://doi.org/10.1016/j.japh.2023.01.016.
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    Eligibility inquiries utilize the NCPDP Telecommunication standard 
or Accredited Standards Committee X12N 270/271 inquiry and response 
transaction for pharmacy or other 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 Sec.  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 Sec.  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.

[[Page 51242]]

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 Sec.  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 Sec.  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
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    \10\ https://standards.ncpdp.org/Our-Process.aspx.
    \11\ 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.
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    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\ 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--
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    \14\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf.
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     General extensibility; \15\
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    \15\ 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.
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     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 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--
---------------------------------------------------------------------------

    \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 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.
    \17\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf.
---------------------------------------------------------------------------

     Addition of an optional element in the header for 
OtherReferenceNumber for multi-party 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.
    NCPDP has also published frequently asked questions \18\ related to 
the use of

[[Page 51243]]

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).
---------------------------------------------------------------------------

    \18\ 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.
---------------------------------------------------------------------------

    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 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 Sec.  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 Sec.  
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 Sec.  423.160(b)(4).
    With respect to ePA transactions in the NCPDP SCRIPT standard 
currently listed at Sec.  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 Sec.  
423.160(b)(1)(i)(V)-(Z). We proposed new language at Sec.  
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 Sec.  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.
---------------------------------------------------------------------------

    \19\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf.
---------------------------------------------------------------------------

    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 in regulation. As part of our proposed 
reorganization of Sec.  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 
Sec.  423.160(b)(1)(i)(A) through (Z), as described in Table 1.

[[Page 51244]]



  Table 1--Proposed Transactions for Communication of Prescription and
    Prescription Related Information Using the NCPDP Script Standard
------------------------------------------------------------------------
                                              Function supported by
              Transaction                        transaction \20\
------------------------------------------------------------------------
GetMessage.............................  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.
Status.................................  Relays acceptance of a
                                          transaction back to the
                                          sender.
Error..................................  Indicates an error has occurred
                                          indicating the request was
                                          terminated.
RxChangeRequest and RxChangeResponse...  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.
RxRenewalRequest and RxRenewalResponse.  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.
Resupply...............................  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.
Verify.................................  Response to a pharmacy or
                                          prescriber indicating that a
                                          transaction requesting a
                                          return receipt has been
                                          received.
CancelRx and CancelRxResponse..........  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.
RxFill.................................  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.
DrugAdministration.....................  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.
NewRxRequest...........................  Request from a pharmacy to a
                                          prescriber for a new
                                          prescription for a patient. If
                                          approved, a NewRx transaction
                                          will be sent.
NewRx..................................  New prescription is sent from
                                          the prescriber to the pharmacy
                                          electronically so it can be
                                          dispensed to a patient.
NewRxResponseDenied....................  Denied response to a previously
                                          sent NewRxRequest.
RxTransferInitiationRequest (previously  Used when the destination
 named RxTransferRequest in NCPDP         pharmacy is asking for a
 SCRIPT standard version 2017071).        transfer of one or more
                                          prescriptions for a specific
                                          patient from the source
                                          pharmacy.
RxTransfer (previously named             In the solicited model, it is
 RxTransferResponse NCPDP SCRIPT          the response to the
 standard version 2017071).               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.
RxTransferConfirm......................  Used by the destination
                                          pharmacy to confirm the
                                          transfer prescription has been
                                          received and the transfer is
                                          complete.
RxFillIndicatorChange..................  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.
Recertification........................  Notification on behalf of a
                                          reviewing provider to a
                                          pharmacy recertifying the
                                          continued administration of a
                                          medication order. Used in
                                          LTPAC only.
REMSInitiationRequest and                Request to the REMS
 REMSInitiationResponse.                  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.
REMSRequest and REMSResponse...........  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.
RxHistoryRequest and RxHistoryResponse.  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.

[[Page 51245]]

 
PAInitiationRequest and                  Request from the submitter to a
 PAInitiationResponse.                    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.
PARequest and PAResponse...............  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.
PAAppealRequest and PAAppealResponse...  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.
PACancelRequest and PACancelResponse...  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.
PANotification.........................  Alerts the pharmacist or
                                          prescriber when a PA has been
                                          requested, or when a PA
                                          determination has been
                                          received.
------------------------------------------------------------------------

     
---------------------------------------------------------------------------

    \20\ 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.
---------------------------------------------------------------------------

    The transactions specific to electronic prescribing remain the same 
as those required for NCPDP SCRIPT standard version 2017071 (currently 
codified at Sec.  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, Sec.  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 Sec.  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

[[Page 51246]]

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 guidance \22\ 
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 Sec. Sec.  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 requirements, as previously 
described, while implementing other updates associated with NCPDP 
SCRIPT standard version 2023011 at a later time.
---------------------------------------------------------------------------

    \21\ https://www.healthit.gov/isa/section/pharmacyinteroperability.
    \22\ Supporting Electronic Prescribing Under Medicare Part D. 
September 19, 2008. https://www.hhs.gov/guidance/document/supporting-electronic-prescribing-under-medicare-part-d.
---------------------------------------------------------------------------

    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 
Sec.  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 Sec.  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 adoption \23\ 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 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.
---------------------------------------------------------------------------

    \23\ https://www.healthit.gov/isa/allows-a-pharmacy-request-respond-or-confirm-a-prescription-transfer.
    \24\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf.
---------------------------------------------------------------------------

    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

[[Page 51247]]

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.
---------------------------------------------------------------------------

    \25\ 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 Sec.  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 Sec.  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 (Sec.  
423.160(b)(1)(i)(A) through (T)), medication history (Sec.  
423.160(b)(1)(i)(U), and electronic prior authorization (Sec.  
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, Sec.  
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 Sec.  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 Sec.  
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--
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    \26\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf.
    \27\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf.
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     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

[[Page 51248]]

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 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.
---------------------------------------------------------------------------

    \28\ 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-and-challenges.
    \30\ American Medical Association. Council on Medical Service. 
Access to Health Plan Information regarding Lower-Cost Prescription 
Options (Resolution 213-NOV-20). Available from https://councilreports.ama-assn.org/councilreports/downloadreport?uri=/councilreports/n21_cms_report_2.pdf.
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    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 
Sec.  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.
    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 Sec.  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.

[[Page 51249]]

    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.
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    \31\ Public Law 116-260 (December 27, 2020). https://www.congress.gov/bill/116th-congress/house-bill/133.
---------------------------------------------------------------------------

    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 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\
---------------------------------------------------------------------------

    \32\ https://www.medicare.gov/my/medicare-complaint/.
---------------------------------------------------------------------------

    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 Sec.  423.160(b)(7) in the May 2019 final rule (which we 
are renumbering to Sec.  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 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 
beneficiary-facing 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:

[[Page 51250]]

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 
Sec.  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 Sec.  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 Sec. Sec.  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:
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    \33\ 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 May-Jun;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-and-Benefit-V60-Request.pdf.
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     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.
    Following an approach similar to those discussed in sections 
II.A.4. and II.A.5. of this rule, CMS proposed at Sec.  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 Sec.  423.160(b)(3) (previously adopted at Sec.  423.160(b)(5)(iii)) 
and the incorporation by reference of that version in the Part D 
regulation at Sec.  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 Sec.  423.160(b)(3),

[[Page 51251]]

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 Sec.  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.
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    \35\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf.
    \36\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf.
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    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 Sec.  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.
    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 Sec.  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 Sec. Sec.  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 2022 \37\ that

[[Page 51252]]

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.
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    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, 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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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

[[Page 51253]]

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 Sec.  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 Sec.  423.160 the standards that ONC updates at 45 CFR 
170.205(b), (c), and (u). We believe the incorporation by reference in 
Sec.  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 Sec.  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.
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    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.
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 Sec.  
423.160(b)(3)(i) and (ii) name the Accredited Standards Committee X12N 
270/271-Health 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 Sec.  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 Sec.  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 Sec. Sec.  
423.160(b)(3)(i) and (ii)

[[Page 51254]]

and modify paragraph Sec.  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.
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    After consideration of the public comments we received, we are 
finalizing, in Sec.  423.160(b)(2), the cross-reference to 45 CFR 
162.1202 for eligibility transactions as proposed.
10. Technical Changes Throughout Sec.  423.160
    In the spirit of alignment with ONC's approach to adopting 
standards, we reviewed Sec.  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 removing reference to old effective dates 
(for example, ``After January 1, 2009 . . .'' at Sec.  
423.160(a)(3)(ii)). Additionally, certain exemptions have long since 
expired. For example, at Sec.  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 Sec.  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 Sec.  423.160(a)(3)(iii) was previously codified at Sec.  
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 Sec.  
423.160(a)(ii) was redesignated as paragraph Sec.  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 E-Prescribing 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 Sec.  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 Sec.  423.160(a)(1)-(2) already indicate that the 
entities listed must comply with the applicable standards in Sec.  
423.160(b); therefore, the language currently at Sec.  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 Sec.  
423.160(b)(1). Moreover, Sec. Sec.  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 
Sec.  423.160(b)(2), ``Medication History'' at Sec.  423.160(b)(4), and 
``Electronic Prior Authorization'' at Sec.  423.160(b)(8) have resulted 
in multiple versions of the NCPDP SCRIPT standard, and relevant 
transactions, being repeated in these sections. Because Sec. Sec.  
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 Sec.  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 Sec. Sec.  
423.160(b)(4) and (8). We proposed to relocate the ePA transactions 
previously listed at Sec.  423.160(b)(8)(i)(A) through (D) to Sec.  
423.160(b)(1)(i)(V) through (Y). We proposed to delete reference to 
versions of the NCPDP F&B standard, currently codified at Sec. Sec.  
423.160(b)(5), 423.160(b)(5)(i), and 423.160(b)(5)(ii), that are no 
longer applicable. The remaining paragraphs in Sec.  423.160(b) would 
be renumbered such that Sec.  423.160(b)(2) would refer to eligibility, 
Sec.  423.160(b)(3) would refer to formulary and benefits, Sec.  
423.160(b)(4) would refer to provider identifier, and Sec.  
423.160(b)(5) would refer to real-time benefit tools.
    We proposed to delete standards incorporated by reference at Sec.  
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.

[[Page 51255]]

The standards incorporated by reference at Sec. Sec.  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 Sec. Sec.  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 Sec.  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 
Sec.  423.160(c)(1)(vii). We proposed to renumber this incorporation by 
reference as Sec.  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 Sec.  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 Sec.  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 
Sec.  423.160(c)(1)(vi). We proposed to renumber this incorporation by 
reference as Sec.  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 Sec.  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 
[email protected].
    We received no comments on these proposals and therefore are 
finalizing the incorporation by reference provisions with typographical 
and technical changes to Sec.  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 Sec.  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 Sec.  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 Sec.  423.160(b)(3), beginning January 1, 
2027, transmission of formulary and benefit information

[[Page 51256]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  423.160(c)(3); NCPDP 
Real-Time Prescription Benefit Standard, Implementation Guide Version 
13 at Sec.  423.160(c)(4); and NCPDP Formulary and Benefit Standard, 
Implementation Guide Version 60, at Sec.  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

[[Page 51257]]

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 
framework \40\ 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\
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    \40\ HITAC Policy Framework Recommendations, February 21, 2018: 
https://www.healthit.gov/sites/default/files/page/2019-07/2018-02-21_HITAC_Policy-Framework_FINAL_508-signed.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/2020-03/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.
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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 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

[[Page 51258]]

single Code of Federal Regulations location at 45 CFR 170.205, where 
CMS proposed to cross-reference these standards for requirements in the 
Part D program.
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    \43\ 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.
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    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.
    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.
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    \44\ See https://www.healthit.gov/isa.
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    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 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.
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    \45\ See https://www.healthit.gov/isa/section/pharmacyinteroperability.
    \46\ See https://www.healthit.gov/isa/section/administrative-transactions-non-claims.
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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 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\
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    \47\ See https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf.
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    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 Sec.  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.
    Comment: Commenters supported the proposed adoption of the NCPDP

[[Page 51259]]

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 Sec.  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), Public Law 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 2020 \49\ and discussed the NCPDP RTPB standard as 
an important tool for addressing administrative transactions around 
prescribing.
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    \48\ See https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf.
    \49\ See https://www.healthit.gov/sites/default/files/page/2020-11/2020-11-17_ICAD_TF_FINAL_Report_HITAC.pdf.
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    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 13 \50\ 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.
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    \50\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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    We requested comment on these proposals and received several 
comments. A discussion of these

[[Page 51260]]

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 13 \51\ 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 Sec.  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.
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    \51\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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c. NCPDP Formulary and Benefit (F&B) Standard Version 60 (45 CFR 
170.205(u))
    The NCPDP F&B standard version 60 \52\ 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.
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    \52\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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    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 Sec.  
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) 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

[[Page 51261]]

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 A-119 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 Sec.  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 prescription-related 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''),

[[Page 51262]]

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-of-Pocket 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

[[Page 51263]]

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

0
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.


0
2. Section 423.160 is revised to read as follows:


Sec.  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 
prescription-related 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 non-prescribing 
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 e-prescribing 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

[[Page 51264]]

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 real-time benefit tools (RTBT) that are capable of 
integrating with at least one prescriber's e-Prescribing (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: [email protected]. For information on the availability of 
this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. 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: [email protected]; website: www.ncpdp.org.
    (1) NCPDP Formulary and Benefit Standard, Implementation Guide,

[[Page 51265]]

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, ANSI-approved 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

0
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.

0
4. Section 170.205 is amended by--
0
a. Revising paragraphs (b)(1) and (2).
0
b. Adding paragraph (c); and
0
c. Adding paragraph (u).
    The revision and additions read as follows:


Sec.  170.205   Content exchange standards and implementation 
specifications for exchanging electronic health information.

* * * * *
    (b) * * *
    (1) Standard. National Council for Prescription Drug Programs 
(NCPDP): SCRIPT Standard Implementation Guide; Version 2017071 
(incorporated by reference in Sec.  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 Sec.  170.299).
    (c) Real-time prescription benefit--(1) Standard. NCPDP Real-Time 
Prescription Benefit Standard, Implementation Guide, Version 13 
(incorporated by reference in Sec.  170.299).
    (2) [Reserved]
* * * * *
    (u) Formulary and benefit--(1) Standard. NCPDP Formulary and 
Benefit Standard Version 60 (incorporated by reference in Sec.  
170.299).
    (2) [Reserved]
* * * * *

0
4. Section 170.299 is amended by revising paragraph (k) to read as 
follows:


Sec.  170.299   Incorporation by reference.

* * * * *
    (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 Sec.  170.205(b).
    (2) NCPDP SCRIPT Standard, Implementation Guide, Version 2023011, 
ANSI-approved January 17, 2023; IBR approved for Sec.  170.205(b).
    (3) NCPDP Real-Time Prescription Benefit Standard, Implementation 
Guide, Version 13, ANSI-approved May 19, 2022; IBR approved for Sec.  
170.205(c).
    (4) NCPDP Formulary and Benefit Standard, Implementation Guide, 
Version 60, ANSI-approved April 12, 2023; IBR approved for Sec.  
170.205(u).
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-12842 Filed 6-13-24; 4:15 pm]
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