Federal Register, Volume 89 Issue 117 (Monday, June 17, 2024)

[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]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 423

Office of the Secretary

45 CFR Part 170

[CMS-4205-F2]
RIN 0938-AV24

Medicare Program; Medicare Prescription Drug Benefit Program;
Health Information Technology Standards and Implementation
Specifications

AGENCY: Centers for Medicare & Medicaid Services (CMS), Office of the
National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services (HHS).

ACTION: Final rule.

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

SUMMARY: This final rule will revise the Medicare Prescription Drug
Benefit (Part D) and ONC regulations to implement changes related to
required standards for electronic prescribing and adoption of health
information technology (IT) standards for HHS use.

DATES: These regulations are effective 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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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

\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).
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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}
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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

\14\ https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf.
---------------------------------------------------------------------------

General extensibility; \15\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

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

\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:
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

\37\ Public Law 117-169. https://www.congress.gov/bill/117th-congress/house-bill/5376/text.
---------------------------------------------------------------------------

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

\38\ https://www.healthit.gov/topic/standards-version-advancement-process-svap.
---------------------------------------------------------------------------

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

\39\ https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/covered-entities.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

\44\ See https://www.healthit.gov/isa.
---------------------------------------------------------------------------

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

\45\ See https://www.healthit.gov/isa/section/pharmacyinteroperability.
\46\ See https://www.healthit.gov/isa/section/administrative-transactions-non-claims.
---------------------------------------------------------------------------

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

\47\ See https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf.
---------------------------------------------------------------------------

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

\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.
---------------------------------------------------------------------------

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

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

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

\51\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
---------------------------------------------------------------------------

c. NCPDP Formulary and Benefit (F&B) Standard Version 60 (45 CFR
170.205(u))
The NCPDP F&B standard version 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.
---------------------------------------------------------------------------

\52\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
---------------------------------------------------------------------------

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]
BILLING CODE P