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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-12842

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** June 17, 2024
- **Citation:** 89 FR 51238

## Text

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

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 § 423.160.

II. Enhancements to the Medicare Prescription Drug Benefit Program

A. Standards for Electronic Prescribing (§ 423.160)

1. Legislative Background

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

2. Regulatory History

As specified at § 423.160(a)(1), Part D sponsors are required to support the Part D e-prescribing program transaction standards as part of their electronic prescription drug programs, as described under § 423.159(c). Likewise, as specified at § 423.160(a)(2), prescribers and dispensers that conduct electronic transactions for covered Part D drugs for Part D eligible individuals for which a program standard has been adopted must do so using the adopted standard. Transaction standards are periodically updated to take new knowledge, technology, and other considerations into account. As CMS adopted specific versions of the standards when it initially adopted the foundation and final e-prescribing standards, there was a need to establish a process by which the standards could be updated or replaced over time to ensure that the standards did not hold back progress in the health care industry. CMS discussed these processes in the final rule titled “Medicare Program; E-Prescribing and the Prescription Drug Program,” (hereinafter referred to as “the November 2005 final rule”) which appeared in the November 7, 2005
Federal Register
(70 FR 67579). An account of successive adoption of new and retirement of previous versions of various e-prescribing standards is described in the final rule titled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014,” which appeared in the December 10, 2013
Federal Register
(78 FR 74229); the proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program,” which appeared in the November 28, 2017
Federal Register
(82 FR 56336); and the corresponding final rule (83 FR 16440), which appeared in the April 16, 2018
Federal Register
. The final rule titled “Medicare Program; Secure Electronic Prior Authorization For Medicare Part D,” which appeared in the December 31, 2020
Federal Register
(85 FR 86824), codified the requirement that Part D sponsors support the use of NCPDP SCRIPT standard version 2017071 for certain ePA transactions (85 FR 86832).

The final rule titled “Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses,” (herein after referred to as “the May 2019 final rule”) which appeared in the May 23, 2019
Federal Register
(84 FR 23832), codified at § 423.160(b)(7) the requirement that Part D sponsors adopt an electronic RTBT capable of integrating with at least one prescriber's electronic prescribing or electronic health record (EHR) system, but did not name a standard since no standard had been identified as the industry standard at the time (84 FR 23851). The electronic standards for eligibility transactions were codified in the final rule titled “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction,” which appeared in the May 16, 2012
Federal Register
(77 FR 29001), to align with the applicable HIPAA transaction standards.

The Part D program has historically adopted electronic prescribing

standards independently of other HHS components that may adopt electronic prescribing standards under separate authorities; however, past experience has demonstrated that duplicative adoption of health IT standards by other agencies within HHS under separate authorities can create significant burden on the health care industry as well as HHS when those standards impact the same technology systems. Notably, independent adoption of the NCPDP SCRIPT standard version 2017071 by CMS in various subsections of § 423.160 (83 FR 16638) in 2018, which required use of the standard beginning in 2020, led to a period where ONC had to exercise special enforcement discretion in its Health Information Technology (IT) Certification Program until the same version was incorporated into regulation at 45 CFR 170.205(b)(1) through the final rule titled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program,” (hereinafter referred to as the “ONC Cures Act final rule”), which appeared in the May 1, 2020
Federal Register
(85 FR 25679). This resulted in significant impact on both ONC and CMS program resources. Similarly, the final rule titled “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction,” which appeared in the May 16, 2012
Federal Register
(77 FR 29002), noted that, in instances in which an e-prescribing standard has also been adopted as a HIPAA transaction standard in 45 CFR part 162, the process for updating the e-prescribing standard will have to be coordinated with the maintenance and modification of the applicable HIPAA transaction standard (77 FR 29018).

3. Withdrawal of Previous Proposals and Summary of New Proposals

In the proposed rule titled, “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications” (hereinafter referred to as “the December 2022 proposed rule”), which appeared in the
Federal Register
on December 27, 2022 (87 FR 79452), we proposed updates to the electronic prescribing standards to be used by Part D sponsors, prescribers, and dispensers when electronically transmitting prescriptions and prescription-related information for covered Part D drugs for Part D eligible individuals . The proposals in the December 2022 proposed rule included a novel approach to updating electronic prescribing standards by proposing to cross-reference Part D requirements with standards adopted by the Office of the National Coordinator for Health Information Technology (ONC) and the standards adopted by HHS for electronic transactions under HIPAA,
1

rather than the historical approach of adopting electronic prescribing standards in the Part D regulations 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 § 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 § 423.160(b)(5)(iii) and proposed to be moved to § 423.160(b)(3) consistent with the proposed technical changes discussed in section II.A.10 of this rule) or NCPDP F&B standard version 60, proposed for adoption for HHS use at 45 CFR 170.205(u)(1).

• Cross-referencing standards adopted for eligibility transactions in HIPAA regulations at 45 CFR 162.1202 for requirements related to eligibility inquiries.

• Making multiple technical changes to the regulation text throughout § 423.160 by removing requirements and incorporations by reference that are no longer applicable, 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

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 § 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 § 423.160(b)(7), CMS requires that Part D sponsors implement one or more electronic RTBTs that are capable of integrating with at least one prescriber's electronic prescribing system or electronic health record, as of January 1, 2021; however, at the time CMS established this requirement, no single industry standard for real-time prescription benefit applications was available. NCPDP has since developed the NCPDP RTPB standard. We proposed to require the most current version, NCPDP RTPB standard version 13, as the standard for prescriber RTBTs at § 423.160(b)(5) starting January 1, 2027.

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 § 423.160(b)(3) to require that eligibility transactions utilize the applicable standard named as the HIPAA standard for electronic eligibility transactions at 45 CFR 162.1202. Since 45 CFR 162.1202 currently identifies the same standards that are named at § 423.160(b)(3)(i) and (ii), we anticipated there would be no immediate impact from this proposed change in regulatory language. We proposed this change to ensure that Part D electronic prescribing requirements for eligibility transactions align with the HIPAA standard for electronic eligibility transactions, should a newer version of the NCPDP Telecommunication (or other) standards be adopted as the HIPAA standard for these types of electronic transactions, if HHS' proposals in the November 2022 Administrative Simplification proposed rule are finalized or as a result of any future HHS rules.

4. Requiring NCPDP SCRIPT Standard Version 2023011 as the Part D Electronic Prescribing Standard, Retirement of NCPDP SCRIPT Standard Version 2017071, and Related Conforming Changes in § 423.160

The NCPDP SCRIPT standard has been the adopted electronic prescribing standard for transmitting prescriptions and prescription-related information using electronic media for covered Part D drugs for Part D eligible individuals since foundation standards were named in the final rule titled “Medicare Program; E-Prescribing and the Prescription Drug Program,” which appeared in the November 7, 2005
Federal Register
(70 FR 67568), at the start of the Part D program. The NCPDP SCRIPT standard is used to exchange information among prescribers, dispensers, intermediaries, and Medicare prescription drug plans. In addition to electronic prescribing, the NCPDP SCRIPT standard is used in electronic prior authorization (ePA) and medication history transactions.

Although electronic prescribing is optional for physicians, except as to Schedule II, III, IV, and V controlled substances that are Part D drugs prescribed under Part D, and pharmacies, the Medicare Part D statute and regulations require drug plans participating in the prescription benefit to support electronic prescribing, and physicians and pharmacies who elect to transmit prescriptions and related communications electronically must utilize the adopted standards except in limited circumstances, as codified at § 423.160(a)(3).

NCPDP's standards development process involves a consensus-based approach to solve emerging needs of the pharmacy industry or to adapt NCPDP standards to changes made by other standards development organizations.
10

Emerging needs of the pharmacy industry may be the result of legislative or regulatory changes, health IT innovations, patient safety issues, claims processing issues, or electronic prescribing-related process automation.
11

Changes to standards are consensus-based and driven by the NCPDP membership, which includes broad representation from pharmacies, insurers, pharmacy benefit managers, Federal and State government agencies, and vendors serving all the stakeholders.
12 13

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

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 § 423.160(b)(4)(ii) does not list the NCPDP SCRIPT standard-specific medication history transactions. Commenters requested that CMS list the corresponding medication history transactions (RxHistoryRequest and RxHistoryResponse) in the regulation text in order to minimize ambiguity. After considering these comments, in the November 2023 proposed rule, we proposed to list the RxHistoryRequest and RxHistoryResponse transactions at § 423.160(b)(1)(i)(U) subsequent to our technical reorganization of the section discussed in section II.A.10. of this rule, rather than list the transactions under § 423.160(b)(4).

With respect to ePA transactions in the NCPDP SCRIPT standard currently listed at § 423.160(b)(8)(i)(A) through (D) (PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse, PAAppealRequest, PAAppealResponse, PACancelRequest, PACancelResponse) and a new ePA transaction (PANotification) available in NCPDP SCRIPT standard version 2023011, we proposed to list all transactions at § 423.160(b)(1)(i)(V)-(Z). We proposed new language at § 423.160(b)(1) to indicate that the transactions listed must comply with a standard in proposed 45 CFR 170.205(b) “as applicable to the version of the standard in use,” since an older version of a standard may not support the same transactions as the newer version of the standard. For example, during the proposed transition period where either NCPDP SCRIPT standard version 2017071 or NCPDP SCRIPT standard version 2023011 may be used, entities that are still using NCPDP SCRIPT standard version 2017071 would not be expected to use the PANotification transaction because the PANotification transaction is only supported in the NCPDP SCRIPT standard version 2023011.

Since the NCPDP SCRIPT standard version 2023011 is fully backwards compatible with NCPDP SCRIPT standard version 2017071, the pharmacies, payers, prescribers, health IT vendors, and intermediaries involved in electronic prescribing can accommodate a transition period when either version may be used. That is, during a transition period, transactions taking place between entities using different versions of the same standard maintain interoperability without the need for entities to utilize (that is, purchase) a translator software program. The cross-reference to proposed 45 CFR 170.205(b) permits a transition period starting as of the effective date of a final rule during which either NCPDP SCRIPT standard version 2017071 or NCPDP SCRIPT standard version 2023011 may be used.

Instead of proposing to independently adopt NCPDP SCRIPT standard version 2023011, we proposed at § 423.160(b)(1) to cross-reference a standard in 45 CFR 170.205(b). ONC proposed to adopt NCPDP SCRIPT standard version 2023011 in 45 CFR 170.205(b)(2) as described in section III.C.8.a. of the November 2023 proposed rule. This approach enables CMS and ONC to avoid misalignment from independent adoption of NCPDP SCRIPT standard version 2023011 for their respective programs. Updates to the standard would impact requirements for both programs at the same time, ensure consistency, and promote alignment for providers, payers, and health IT developers participating in and supporting the same prescription transactions. See section II.B.5. of this rule for additional discussion of this coordination effort.

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 § 423.160, we proposed to list all transactions associated with the NCPDP SCRIPT standard requirements in one place in the regulation. We proposed the transactions for prescriptions, ePA, and medication history for which use of the standard is mandatory at § 423.160(b)(1)(i)(A) through (Z), as described in Table 1.

Table 1—Proposed Transactions for Communication of Prescription and Prescription Related Information Using the NCPDP Script Standard

Transaction

Function supported by 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 named RxTransferRequest in NCPDP SCRIPT standard version 2017071)
Used when the destination pharmacy is asking for a transfer of one or more prescriptions for a specific patient from the source pharmacy.

RxTransfer (previously named RxTransferResponse NCPDP SCRIPT standard version 2017071)
In the solicited model, it is the response to the RxTransferInitiationRequest which includes the prescription(s) being transferred from the source pharmacy to the destination pharmacy or a rejection of the transfer request. In the unsolicited model, it is a push of the prescription(s) being transferred from the source pharmacy to the destination pharmacy.

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 REMSInitiationResponse
Request to the REMS Administrator for the information required to submit a REMS request (REMSRequest) for a specified patient and drug. Response is from the REMS Administrator with the information required to submit a REMS request (REMSRequest) for a specified patient and drug.

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.

PAInitiationRequest and PAInitiationResponse
Request from the submitter to a payer for the information required to submit a prior authorization request (PARequest) for a specified patient and product. Response is from a payer to the submitter with the information required to submit a prior authorization request (PARequest) for a specified patient and product.

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 § 423.160(b)(2)(iv)(A) through (Z)), except where renamed as noted in Table 1. The transactions specific to ePA are also the same as those required with NCPDP SCRIPT standard version 2017071 (with one additional transaction—PA Notification), which was incorporated into the standard after NCPDP SCRIPT standard version 2017071. As discussed in section II.B.8.a. of this rule, NCPDP SCRIPT standard version 2023011 was proposed for adoption at 45 CFR 170.205(b)(2), and NCPDP SCRIPT standard version 2017071 was proposed to expire January 1, 2027 at 45 CFR 170.205(b)(1).

As stated previously, in response to the December 2022 proposed rule, several commenters pointed out that if mandatory use of an updated version of the NCPDP SCRIPT standard is delayed, then the EPCS requirement in LTC facilities should also be delayed accordingly, since NCPDP SCRIPT standard version 2017071 lacks appropriate guidance for LTC facilities. CMS was aware of this limitation in the NCPDP SCRIPT standard version 2017071, and acknowledged the challenges to EPCS faced by LTC facilities in the proposed rule “Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements” (hereinafter referred to as “the July 2022 proposed rule”), which appeared in the
Federal Register
on July 23, 2021 (86 FR 39104). However, in the July 2022 proposed rule, CMS also stated that we understood that NCPDP was in the process of creating specific guidance for LTC facilities within the NCPDP SCRIPT standard version 2017071, which would allow willing partners to enable 3-way communication between the prescriber, LTC facility, and pharmacy to bridge any outstanding gaps that impede adoption of the NCPDP SCRIPT standard version 2017071 in the LTC setting (86 FR 39329).

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

As proposed, § 423.160(b)(1) would require use of a version of the NCPDP SCRIPT standard adopted in 45 CFR 170.205(b) to carry out the transactions listed in § 423.160(b)(1)(i)(A) through (Z). However, it would not require that all transactions be utilized if they are not needed or are not relevant to the entity. We refer readers to ONC's Interoperability Standards Advisory (ISA) website for descriptions and adoption level of transactions in the

NCPDP SCRIPT standard.
21

For example, we have been informed that the “GetMessage” transaction described in Table 1 is not widely used among prescribers. For this reason, we are reiterating 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 §§ 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 § 423.160(b)(1) that would—

• Consolidate all transactions for electronic prescribing, ePA, and medication history for which use of the NCPDP SCRIPT standard is mandatory at § 423.160(b)(1)(i)(A)-(Z); and

• Indicate that communication of prescriptions and prescription-related transactions listed must comply with a standard in 45 CFR 170.205(b). In conjunction with ONC proposals (discussed in section II.B.8.a. of this rule), this cross-reference would permit a transition period when either NCPDP SCRIPT standard versions 2017071 or 2023011 may be used beginning as of the effective date of a final rule and ending January 1, 2027, because, as ONC proposed at 45 CFR 170.205(b)(1), the NCPDP SCRIPT standard version 2017071 would expire January 1, 2027, after which only NCPDP SCRIPT standard version 2023011 would be available for HHS use.

We solicited comment on these proposals. A discussion of the comments received, along with our responses, follows.

Comment:
All commenters supported the proposal to update NCPDP SCRIPT standard version 2017071 to NCPDP SCRIPT standard version 202311 for the electronic transmission of prescriptions and prescription-related information, including medication history and ePA.

Response:
We thank commenters for their support.

Comment:
Several commenters expressed concern over the proposed date of January 1, 2027 when use of NCPDP SCRIPT standard version 2023011 would be required.

Response:
See section II.A.7. of this rule for discussion of this concern.

Comment:
One commenter requested that the exemption from the use of the NCPDP SCRIPT standard (and when use of HL7 messages are permitted) for the transmission of prescriptions and prescription-related information internally when the sender and recipient are part of the same legal entity be extended to the prescription transfer transactions when the sender and the recipient are not part of the same legal entity. For example, transferring a prescription between a pharmacy that is part of a health maintenance organization (HMO) and pharmacy that is not part of the HMO could be done using HL7 messaging rather than the NCPDP SCRIPT standard version 2023011 RxTransferInitiationRequest, RxTransfer, and RxTransferConfirm transactions (or NCPDP SCRIPT standard version 2017071 RxTransferRequest, RxTransferResponse, and RxTransferConfirm transactions).

Response:
The commenter did not provide an explanation for why the commenter requested that we create an exemption from use of the NCPDP SCRIPT standard for prescription transfer transactions between pharmacies, so CMS attempted to investigate the issue raised by the commenter. We found evidence that prescription transfer transactions are at a low level of 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

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 § 423.160(b)(1), that communication of a prescription and prescription-related information must comply with a standard in 45 CFR 170.205(b) for the transactions listed at § 423.160(b)(1)(i)(A) through (Z), as applicable to the version of the standard in use. We are also finalizing our proposals to consolidate required transactions for prescriptions (§ 423.160(b)(1)(i)(A) through (T)), medication history (§ 423.160(b)(1)(i)(U), and electronic prior authorization (§ 423.160(b)(1)(i)(V) through (Z)) together since all transactions are specific to the NCPDP SCRIPT standard versions ONC has previously adopted or is adopting at 45 CFR 170.205(b) as described in section II.B.8.a. of this final rule.

Taken in conjunction with the standards and expiration date adopted by ONC, as described in section II.B.8.a. of this final rule, § 423.160(b)(1) will require use of NCPDP SCRIPT standard version 2023011, which ONC is adopting at 45 CFR 170.205(b)(2), beginning January 1, 2028, and retire use of NCPDP SCRIPT standard version 2017071, which ONC previously adopted at 45 CFR 170.205(b)(1) and to which it is applying an expiration date of January 1, 2028. As both NCPDP SCRIPT standard version 2017071 and NCPDP SCRIPT standard version 2023011 will be adopted at 45 CFR 170.205(b) and unexpired as of the effective date of this final rule, entities subject to the requirement at § 423.160(b)(1) may use either version of the NCPDP SCRIPT standard during the transition period beginning the effective date of this final rule, and ending December 31, 2027, which is the last day before NCPDP SCRIPT standard version 2017071 will expire for the purposes of HHS use.

5. Requiring NCPDP Real-Time Prescription Benefit (RTPB) Standard Version 13

In the May 2019 final rule, which implemented the statutory provision at section 1860D-4(e)(2)(D) of the Act, CMS required at § 423.160(b)(7) that Part D plan sponsors implement, by January 1, 2021, one or more electronic RTBT capable of integrating with at least one prescriber's e-prescribing system or EHR to provide prescribers with complete, accurate, timely, clinically appropriate, patient-specific formulary and benefit information. CMS indicated that the formulary and benefit information provided by the tool should include cost, clinically appropriate formulary alternatives, and utilization management requirements because, at that time, an industry standard for RTBTs had not been identified (84 FR 23833). NCPDP has since developed and tested the NCPDP RTPB standard for use with RTBT applications. The NCPDP RTPB standard enables the real-time exchange of information about patient eligibility and patient-specific formulary and benefit information. For a submitted drug product, the NCPDP RTPB standard will indicate coverage status, coverage restrictions, and estimated patient financial responsibility. “Estimated” financial responsibility accounts for the fact that the RTPB transaction transmits the patient's cost sharing at that particular moment in time, which could later change if the claim is processed at a later date or in a different sequence relative to other claims (for example, an RTPB transaction could show a cost sharing that reflects a deductible or particular stage in the Part D benefit which could be different from when the prescription claim is actually processed by the pharmacy if other claims were processed in the interim). The NCPDP RTPB standard also supports providing information on alternative pharmacies and products. In an August 20, 2021 letter to CMS, NCPDP described these features and recommended adoption of NCPDP RTPB standard version 12.
26

Subsequently, in the December 2022 proposed rule, CMS proposed that Part D sponsors' RTBTs comply with NCPDP RTPB standard version 12. In response to that proposal, NCPDP and many other interested parties provided comments to CMS recommending that CMS instead require NCPDP RTPB standard version 13. In their comments on the December 2022 proposed rule,
27

NCPDP listed enhancements in NCPDP RTPB standard version 13 that improve the information communicated between the payer and the prescriber. These enhancements include—

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

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 × 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 § 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 § 423.160(b)(5) to require that beginning January 1, 2027, Part D sponsors' prescriber RTBT must comply with a standard in 45 CFR 170.205(c).

We solicited comment on these proposals and the related issues raised. A discussion of the comments received, along with our responses, follows.

Comment:
All commenters supported the proposal to require NCPDP RTPB standard version 13 for prescriber RTBTs implemented by Part D sponsors. Several commenters shared their support for CMS's efforts to require a standard to improve transparency and efficiency in the electronic prescribing process for both prescribers and patients. Many commenters expressed support for the standard as a means to move away from limited proprietary RTBTs and move towards widespread access to accurate, detailed, patient-specific cost and coverage information for prescribers at the point of prescribing.

Response:
We thank commenters for their support and for their enthusiasm towards utilizing RTBTs generally.

Comment:
Several commenters expressed concern over the proposed date of January 1, 2027 when use of NCPDP RTPB standard version 13 would be required.

Response:
See section II.A.7. of this rule for discussion of this concern.

Comment:
Several commenters shared their thoughts regarding the issue of whether the number of medications that can be sent in a single request transaction in NCPDP RTPB standard version 13 would present a barrier to existing RTBT functionality. One commenter did not believe the standard would pose a barrier and that implementers could still send more than one transaction simultaneously. Another commenter confirmed that there are occasionally latency issues, but that overall enhancements offered by NCPDP RTPB standard version 13 would outweigh any potential latency issues. Commenters noted that even though the initial request only supports 1 drug per transaction, the response provides multiple alternatives, which meets the health care industry's needs.

Response:
We thank commenters for their feedback on this topic. We are reassured that requiring NCPDP RTPB standard version 13 for prescriber RTBTs implemented by Part D sponsors will meet the health care industry's needs and will enhance rather than impede existing RTBT functionality.

Comment:
Several commenters opined on the specific information communicated in the RTBT response. A commenter requested that CMS address the number and order of pharmacy results based on patient preferences and the frequency and timeliness of Part D plan and RTBT vendor updates to pharmacy network files. The commenter indicated that pharmacies need a dispute process when RTBT responses provide inaccurate pharmacy network status.

Other commenters raised the topic of negotiated prices being displayed in RTBT results, as required for qualifying RTBTs as described in section 119(a) of Subtitle B of Title I, Division CC of CAA, 2021.
31

One commenter supported the use of RTBTs to display a full negotiated price to improve drug cost transparency. Another commenter expressed concern about disclosing negotiated prices, stating that disclosure of such information would have anticompetitive effects and unless CMS and ONC implemented protections to ensure this data is used only to support patient and consumer decision making, there is potential risk of disclosure of negotiated prices to third parties through abuse of RTBT transactions.

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 § 423.160(b)(7) in the May 2019 final rule (which we are renumbering to § 423.160(b)(5) in this final rule) for Part D sponsors to implement, no later than January 1, 2021, one or more RTBTs capable of integrating with at least one prescriber's e-prescribing system or electronic health record, we encouraged, but did not require, Part D sponsors' RTBTs to include negotiated prices.

CAA, 2021 was then enacted after the May 2019 final rule appeared in the
Federal Register
. Section 119(a) of Subtitle B of Title I of Division CC of the CAA, 2021 added section 1860D-4(o) of the Act to require Part D sponsors to implement one or more RTBTs that meet specified requirements after the Secretary has adopted a standard for RTBTs and at a time determined appropriate by the Secretary. The law specified that RTBTs must be capable of, with respect to a covered Part D drug for a specific Part D enrollee, transmitting cost sharing information and the negotiated price of a drug and its formulary alternatives, among other requirements. Similarly, section 119(b) of Subtitle B of Title I of Division CC of the CAA, 2021 amended the definition of a “qualified electronic health record” in section 3000(13) of the Public 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:

Certification Program Updates, Algorithm Transparency, and Information Sharing” (89 FR 1192), which appeared in the January 9, 2024
Federal Register
, and which describes ONC's approach to considering updates to the ONC Health IT Certification Program that could support the availability of RTBTs in certified health IT for use by health care providers.

Comment:
CMS received several comments regarding use of RTBTs. A commenter requested that pharmacists have access to RTBTs. Another commenter requested an exception to the use of RTBTs in LTC or institutional levels of care. A commenter encouraged CMS and ONC to monitor physician utilization of RTBTs to consider the impact in Part D and address barriers to access in future regulation.

Response:
With respect to pharmacists accessing RTBTs, nothing in § 423.160, standards for electronic prescribing, limits RTBT access to particular health care providers where consistent with applicable law. Our understanding is that a decision to expand access to RTBTs to non-prescribing providers, such as pharmacists or other members of a clinical care team, would be made by each health system.

With respect to the request for an exemption from the use of RTBTs in LTC or institutional levels of care, we point out that Part D regulations have never imposed a requirement with respect to the utilization of RTBTs by prescribers. Since January 1, 2021, CMS has required that Part D sponsors implement at least one RTBT capable of integrating with at least one prescriber's e-prescribing system or EHR. Our proposal to require that by January 1, 2027, the Part D sponsor RTBT must comply with NCPDP RTPB standard version 13, which ONC is adopting at 45 CFR 170.205(c)(1), does not impose any new requirement on prescribers to integrate RTBTs into their e-prescribing systems or EHRs or to utilize RTBTs.

With respect to monitoring real-world use of RTBTs, we intend to monitor the published literature and will explore other vehicles for monitoring progress in this area as resources permit.

After consideration of the public comments we received, we are finalizing the requirement as proposed at § 423.160(b)(5) that beginning January 1, 2027, Part D sponsors' prescriber RTBT must comply with a standard in 45 CFR 170.205(c), where ONC is adopting the NCPDP RTPB standard version 13 at 45 CFR 170.205(c)(1) as described in section II.B.8.b. of this rule.

6. Requiring NCPDP Formulary and Benefit Standard Version 60 and Retirement of NCPDP Formulary and Benefit Standard Version 3.0

The NCPDP Formulary and Benefit (F&B) standard provides a uniform means for prescription drug plan sponsors to communicate plan-level formulary and benefit information to prescribers through electronic prescribing/EHR systems. The NCPDP F&B standard transmits, on a batch basis, data on the formulary status of drugs, preferred alternatives, coverage restrictions (that is, utilization management requirements), and cost sharing consistent with the benefit design (for example, cost sharing for drugs on a particular tier). The NCPDP F&B standard serves as a foundation for other electronic prescribing functions including ePA, real-time benefit check, and specialty medication eligibility when used in conjunction with other standards.
33

NCPDP F&B standard version 3.0 is required for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors, consistent with the text of §§ 423.160(b)(1)(v) and 423.160(b)(5)(iii). In an April 4, 2023 letter to CMS, NCPDP requested that CMS adopt NCPDP F&B standard version 60 to replace NCPDP F&B standard version 3.0.
34

A detailed change log was attached to the letter and is available at the link in the footnote. As described in the letter, compared with NCPDP F&B standard version 3.0, NCPDP F&B standard version 60 includes all of the following major enhancements:

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 § 423.160(b)(3) that electronic transmission of formulary and benefit information between prescribers and Medicare Part D sponsors must either utilize NCPDP F&B standard version 3.0 or comply with a standard in 45 CFR 170.205(u), where ONC proposed to adopt, at 45 CFR 170.205(u)(1), NCPDP F&B standard version 60 as described in section II.B.8.c. of this rule. CMS proposed that beginning January 1, 2027, entities transmitting formulary and benefit information would be required to comply with a standard in 45 CFR 170.205(u) exclusively. As a result of these proposals, there would be a transition period where either NCPDP F&B standard version 3.0 or NCPDP F&B standard version 60 could be used until January 1, 2027. Since ONC did not previously adopt NCPDP F&B standard version 3.0, we would be maintaining adoption of the standard at § 423.160(b)(3) (previously adopted at § 423.160(b)(5)(iii)) and the incorporation by reference of that version in the Part D regulation at § 423.160(c)(1).

We solicited comment on these proposals. A discussion of the comments received, along with our responses, follows.

Comment:
All commenters supported the proposal to update NCPDP F&B standard version 3.0 to NCPDP F&B standard version 60. Several commenters acknowledged the complementary role of the NCPDP F&B standard with NCPDP SCRIPT and NCPDP RTPB standards.

Response:
We thank commenters for their support.

Comment:
Several commenters expressed concern over the proposed date of January 1, 2027 when use of the NCPDP F&B standard version 60 would be required.

Response:
For a discussion of the responses to these comments, see section II.A.7. of this rule.

After consideration of the public comments received, we are finalizing the requirement, beginning January 1, 2027 and as proposed at § 423.160(b)(3),

for transmission of formulary and benefit information between Medicare Part D sponsors and prescribers to comply with a standard in 45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60. We are finalizing our proposal to retire use of NCPDP F&B standard version 3.0 for transmitting formulary and benefit information between prescribers and Part D sponsors effective January 1, 2027. A transition period where entities will be permitted to use either NCPDP F&B standard version 3.0 (named at § 423.160(b)(3) consistent with the technical changes in this rule) will begin on the effective date of the final rule and continue through December 31, 2026. Beginning January 1, 2027, only a version of the standard adopted for HHS use at 45 CFR 170.205(u) will be permitted for use, which will be NCPDP F&B standard version 60 as described in section II.B.8.c. of this rule.

7. Date for Required Use of NCPDP SCRIPT Standard Version 2023011, NCPDP RTPB Standard Version 13, and NCPDP F&B Standard Version 60 and Transition Period for NCPDP SCRIPT and F&B Standards

As discussed in the November 2023 proposed rule, we have received feedback on a number of practical considerations for determining a realistic timeframe to implement new or update existing electronic prescribing standards. We have been informed that organizations generally do not budget for new requirements until a final rule has been published establishing a particular new requirement and, therefore, the timing of when a final rule is finalized relative to budget approval cycles can determine if a requirement can be accounted for in the organization's next annual budget. The health IT industry has indicated to CMS that it requires at least 2 years to design, develop, test, and certify software with trading partners; perform DEA audits for EPCS compliance; and roll out updated software to provider organizations and partners who then must train end users before a transition to a new or updated version of a standard is complete. This account is consistent with NCPDP's requests for up to 24-month implementation timeframes for new standards.
35 36

A commenter on the December 2022 proposed rule requested that CMS either permit 3 years from a final rule before requiring use of a new or updated version of a standard, or use enforcement discretion if requiring use of a new or updated version of a standard less than 3 years from a final rule. CMS will generally aim to provide entities with at least 2 years from when a final rule is finalized. However, we qualify that in some cases less time may be provided if determined to be necessary.

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 § 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 § 423.160(b)(1) to a standard in 45 CFR 170.205(b). We proposed the required use of NCPDP F&B standard version 60 and NCPDP RTPB standard version 13 by January 1, 2027, in the text of §§ 423.160(b)(3) and (5) via cross-reference to a standard in 45 CFR 170.205(u) and 170.205(c), respectively. As discussed in sections II.A.4 and II.A.6 of this rule, since NCPDP SCRIPT standard version 2023011 and NCPDP F&B standard version 60 are backwards compatible with NCPDP SCRIPT standard version 2017071 and NCPDP F&B standard version 3.0, respectively, we proposed to permit a transition period when either version could be used. The transition period would begin upon the effective date of the final rule and end on January 1, 2027, which is the expiration date for NCPDP SCRIPT standard version 2017071 proposed by ONC and the date after which CMS proposed to no longer permit use of NCPDP F&B standard version 3.0.

We are also aware that Part D sponsors and the health IT industry are awaiting HHS' final rule on the proposals to update the NCPDP Telecommunication standard from version D.0 to version F6 (87 FR 67638), update the equivalent NCPDP Batch Standard version 15 (87 FR 67639), and implement the NCPDP Batch Standard Pharmacy Subrogation version 10 (87 FR 67640) proposed in the November 2022 Administrative Simplification proposed rule.

Taking all of these proposals into consideration, we asked interested parties to comment on the proposed January 1, 2027 date for the required use of NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60. We noted that the compliance date for the proposals in HHS' November 2022 Administrative Simplification proposed rule was expressly outside the scope of our proposals, and we did not seek comment on it; however, we solicited comments on the feasibility of updating multiple standards simultaneously. A discussion of the comments received, along with our responses, follows.

Comment:
Most commenters supported January 1, 2027 as the date for required use of NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60.

Response:
We thank commenters for their support.

Comment:
Several commenters requested that the date for required use of NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60 be delayed to January 1, 2028. Commenters expressed concern with implementing multiple standards simultaneously at a time when Part D plan and pharmacy benefit manager resources are also focused on system changes related to sections of the Inflation Reduction Act of 2022
37

that

impact Part D sponsors and take effect in 2025 and 2026. A commenter indicated that updating standards in the LTC setting are uniquely challenging such that necessary changes could not be implemented before June 30, 2027.

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 § 423.160(b)(1), which requires compliance with a standard in 45 CFR 170.205(b), in conjunction with ONC finalizing January 1, 2028 as the expiration date for NCPDP SCRIPT standard version 2017071 in 45 CFR 170.205(b)(1) (as discussed in section II.B.8.a. of this final rule). We are finalizing without modification the requirement to use NCPDP F&B standard version 60 by January 1, 2027 by requiring at § 423.160(b)(3), beginning January 1, 2027, compliance with a standard in 45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60 (as discussed in section II.B.8.c. of this final rule). We are finalizing the requirement to use NCPDP RTPB standard version 13 by January 1, 2027 by requiring at § 423.160(b)(5), beginning January 1, 2027, compliance with a standard in 45 CFR 170.205(c), where ONC is adopting NCPDP RTPB standard version 13 (as discussed in section II.B.8.b. of this final rule). The NCPDP F&B standard has not been updated as recently as the NCPDP SCRIPT standard has been updated from the perspective of Part D requirements. Further, we believe that maintaining the proposed timeline to require use of NCPDP RTPB standard version 13 and exclusive use of NCPDP F&B standard version 60 by January 1, 2027 is warranted in order to support prescribers' access to accurate cost and coverage information at the point of prescribing through use of these complimentary standards.

Comment:
A few commenters provided feedback on the transition periods permitted by CMS' proposals. A commenter offered general support for permitting transition periods when backwards compatible versions of standards are available since such periods offer flexibility to the health IT industry and all entities subject to Part D electronic prescribing requirements. Another commenter indicated that if CMS is not specifying the exact dates of transition periods in regulation, there may be confusion among health IT vendors with respect to when system updates can begin. The commenter requested that CMS provide additional communication to the health IT vendor community.

Response:
As discussed in section II.A.8. of this rule, we believe, and most commenters agree, that the aligned approach between CMS and ONC will help alleviate compliance challenges for the health IT vendor community, but we acknowledge that our proposed approach to cross-reference ONC regulations in Part D regulations in § 423.160 is a significant change from the previous approach of naming standards and specific transition periods in the Part D regulations. Part D sponsors will need to engage with their health IT vendors following the effective date of this, and future, final rules to plan for the transition to new required standards. We do not generally intend to specify dates for transition periods in regulation in the future, but we will consider additional means of communicating the updated requirements to Part D sponsors, including specifying the dates of transition periods, to minimize any confusion.

After consideration of the public comments received, we are finalizing the requirement for exclusive use of NCPDP SCRIPT standard version 2023011 by January 1, 2028 as a result of ONC modifying the proposed expiration date for NCPDP SCRIPT standard version 2017071 at 45 CFR 170.205(b)(1) as discussed in section II.B.8.a. of this rule. The transition period during which either NCPDP SCRIPT standard version 2017071 or NCPDP SCRIPT standard version 2023011 may be used will begin on July 7, 2024, the effective date of this final rule, and end on December 31, 2027. We are finalizing the requirement for exclusive use of NCPDP F&B standard version 60 by January 1, 2027 as proposed by requiring at § 423.160(b)(3), beginning January 1, 2027, compliance with a standard in 45 CFR 170.205(u), where ONC is adopting NCPDP F&B standard version 60 (as discussed in section II.B.8.c. of this final rule). The transition period during which either NCPDP F&B standard version 3.0 or NCPDP F&B standard version 60 can be used, will begin on July 7, 2024, the effective date of this final rule, and end on December 31, 2026. We are finalizing the required use of NCPDP RTPB standard version 13 for prescriber RTBTs supported by Part D sponsors by January 1, 2027 as proposed by requiring at § 423.160(b)(5), beginning January 1, 2027, compliance with a standard in 45 CFR 170.205(c), where ONC is adopting NCPDP RTPB standard version 13 (as discussed in section II.B.8.b. of this final rule).

8. CMS-ONC Aligned Approach To Adoption of Electronic Prescribing Standards

We proposed a novel approach to updating e-prescribing standards by cross-referencing Part D e-prescribing requirements with standards, including any expiration dates, adopted by ONC, as discussed in section II.B.5. of this rule. The proposed approach would enable CMS and ONC to avoid misalignment from independent adoption of standards for their respective programs. Updates to the adopted standards would impact requirements for both programs at the same time, ensure consistency, and promote alignment for providers, payers, and health IT developers participating in and supporting the same prescription transactions. A discussion of the comments received on

our proposal, along with our responses, follows.

Comment:
The majority of commenters supported the proposed aligned approach and agreed that it would alleviate compliance challenges for developers and generally help promote consistency and coordination among all parties implementing new standards.

Response:
We thank commenters for their support.

Comment:
A few commenters did not support or expressed concerns about the aligned approach. A commenter raised the point that Part D sponsors are not required to use certified health IT; therefore, the approach to cross-reference standards adopted by ONC in Part D regulation could create confusion about the scope of ONC requirements. A few commenters emphasized that CMS and ONC need to assure process alignment across agencies when ONC adopts new standards so that CMS representatives continue to be involved in determining the new requirements and timing. A commenter noted that there should be a notification process, such as a
Federal Register
announcement or Health Plan Management System (HPMS) memorandum to inform Part D sponsors if ONC plans to update the adopted standards in the future.

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

Comment:
A commenter recommended that CMS should maintain its own standards version advancement process (SVAP) that is focused on the needs of health plans, since the ONC Health IT Certification Program is focused on providers and health IT vendors.

Response:
We thank the commenter for their recommendation. ONC's SVAP permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement at 45 CFR 170.405.
38

Although the ONC SVAP permits the use of newer versions of adopted standards in its ONC Health IT Certification Program, this flexibility does not extend to the Part D program requirements for electronic prescribing. Entities to which the requirements at § 423.160 apply must only use the standard version or versions specified in regulation. We did not propose an equivalent process to ONC's SVAP process for Part D sponsors' electronic prescription drug programs but will take the idea into consideration for future rulemaking.

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 § 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 § 423.160(b)(2), that eligibility inquiries and responses between the Part D sponsor and prescribers and between the Part D sponsor and dispensers would have to comply with the applicable HIPAA regulation in 45 CFR 162.1202, as opposed to naming standards independently, which would ensure, should the HIPAA standards for eligibility transactions be updated as a result of HHS rulemaking or in the future, that the Part D regulation would be synchronized with the required HIPAA standards. We foresee no immediate impact of this proposed change since the HIPAA regulation at 45 CFR 162.1202 currently identifies the same standards as those named in the Part D regulation at § 423.160(b)(3)(i) and (ii), but we believe establishing a cross-reference would help avoid potential future conflicts and mitigate potential compliance challenges for the health care industry and enforcement challenges for HHS.

Thus, we proposed to delete existing paragraphs §§ 423.160(b)(3)(i) and (ii)

and modify paragraph § 423.160(b)(2) (as renumbered per the technical revisions discussed in section II.A.10. of this rule) to require that eligibility transactions must comply with 45 CFR 162.1202.

We solicited comment on these proposals. A discussion of the comments received, along with our responses, follows.

Comment:
All comments received on this proposal were supportive. Several commenters agreed that the cross-reference to HIPAA regulation will alleviate compliance challenges for those required to comply with Part D and HIPAA regulations.

Response:
We thank commenters for their support.

Comment:
A commenter requested that CMS institute a notification process to ensure that entities subject to Part D requirements are made aware of updates when HHS updates the required standards for eligibility transactions.

Response:
Consistent with 45 CFR 162.100, the regulations at 45 CFR 162.1202 apply to covered entities as defined at 45 CFR 160.103. Entities subject to Part D regulations are among those covered entities.
39

We believe that HHS has the means to reach covered entities when it undertakes rulemaking and when new requirements are finalized. Therefore, we do not believe CMS would need to issue separate notice.

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 § 423.160(b)(2), the cross-reference to 45 CFR 162.1202 for eligibility transactions as proposed.

10. Technical Changes Throughout § 423.160

In the spirit of alignment with ONC's approach to adopting standards, we reviewed § 423.160 in its entirety and identified areas where we could reorganize text throughout this section. We do not believe we should continue to list historical requirements that are no longer relevant and have resulted in repetitive content being added to the regulations. We proposed removing reference to old effective dates (for example, “After January 1, 2009 . . .” at § 423.160(a)(3)(ii)). Additionally, certain exemptions have long since expired. For example, at § 423.160(a)(3)(iv), entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser have not been exempt from using the SCRIPT standard since November 1, 2014.

We proposed a correction at § 423.160(a)(3)(iii), where regulation text refers to prescriptions and prescription-related information transmitted “internally when the sender and the beneficiary are part of the same legal entity.” The exemption currently at § 423.160(a)(3)(iii) was previously codified at § 423.160(a)(3)(ii) as “Entities may use either HL7 messages or the NCPDP SCRIPT Standard to transmit prescriptions or prescription-related information internally when the sender and the recipient are part of the same legal entity . . .” as finalized in the November 2005 final rule, which codified the foundation standards for Medicare Part D electronic prescription drug programs (70 FR 67594). Paragraph § 423.160(a)(ii) was redesignated as paragraph § 423.160(a)(iii) subsequent to changes made in the final rule titled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the 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 § 423.160(a)(iii) when it was redesignated, nor can we find evidence of when this paragraph may have been altered in subsequent rules. Therefore, we believe the word “recipient” was inadvertently changed to “beneficiary” in the distant past, and we proposed to change this back to “recipient.”

Paragraphs § 423.160(a)(1)-(2) already indicate that the entities listed must comply with the applicable standards in § 423.160(b); therefore, the language currently at § 423.160(b)(1), “Entities described in paragraph (a) of this section must comply with the following adopted standards for transactions under this section,” is redundant. We proposed to remove it from the text of § 423.160(b)(1). Moreover, §§ 423.160(b)(1)(i) through (iv) and 423.160(b)(2)(i) through (iii) contain long-outdated requirements going back to the start of the electronic prescribing program in Medicare Part D. We proposed to delete references to outdated requirements so that the regulation text would include only relevant and applicable requirements. Transition periods would no longer be specifically spelled out as starting at a particular date (historically, 6 months after the effective date of a final rule). Rather, the transition period would begin as of the effective date of a final rule effectuating a change from one version of a standard to a new version and would last until the prior version of the standard is expired, as proposed to be codified in ONC regulation, or until the date specified in Part D regulation. For versions of standards adopted by ONC, CMS will consider the necessary transition period when working with ONC to establish the appropriate expiration date for prior versions of standards in rulemaking. This would align the Part D approach with the approach that ONC has used in its own regulations.

As currently organized, separate sections for “Prescription” at § 423.160(b)(2), “Medication History” at § 423.160(b)(4), and “Electronic Prior Authorization” at § 423.160(b)(8) have resulted in multiple versions of the NCPDP SCRIPT standard, and relevant transactions, being repeated in these sections. Because §§ 423.160(a)(1) and (2) state that the entities listed must comply “with the applicable standards in paragraph (b),” we believe that we could group the functions in paragraph (b) according to the standard used for those functions to avoid repetition. Therefore, we proposed to combine “Prescriptions, electronic prior authorization, and medication history” at § 423.160(b)(1), which would require the use of the NCPDP SCRIPT standard version or versions as proposed via cross-reference to ONC regulations. We proposed to delete §§ 423.160(b)(4) and (8). We proposed to relocate the ePA transactions previously listed at § 423.160(b)(8)(i)(A) through (D) to § 423.160(b)(1)(i)(V) through (Y). We proposed to delete reference to versions of the NCPDP F&B standard, currently codified at §§ 423.160(b)(5), 423.160(b)(5)(i), and 423.160(b)(5)(ii), that are no longer applicable. The remaining paragraphs in § 423.160(b) would be renumbered such that § 423.160(b)(2) would refer to eligibility, § 423.160(b)(3) would refer to formulary and benefits, § 423.160(b)(4) would refer to provider identifier, and § 423.160(b)(5) would refer to real-time benefit tools.

We proposed to delete standards incorporated by reference at § 423.160(c) that are: no longer applicable (that is, are associated with outdated requirements that we proposed to delete); or are already incorporated by reference by HHS at 45 CFR 162.920.

The standards incorporated by reference at §§ 423.160(c)(1)(i), (ii), (iv), and (v) would no longer be applicable, and we proposed to delete them. The standards for eligibility transactions currently incorporated by reference at §§ 423.160(c)(1)(iii) and 423.160(c)(2) have already been incorporated by reference by HHS at 45 CFR 162.920. We proposed to delete these incorporations by reference in light of our proposal in section II.A.9. of this rule to indicate that entities would be required to comply with 45 CFR 162.1202. That citation indicates where the applicable standards have been incorporated by reference in HHS regulations.

We believe these changes would improve the overall readability of the section. With the exception of changes described in sections II.A.4., II.A.5., II.A.6., and II.A.9., we do not intend for technical changes to alter current requirements.

We solicited comment on these proposals. We received no comments on our proposed technical changes and the correction and therefore are finalizing them as proposed.

11. Incorporation by Reference and Availability of Incorporation by Reference Materials

The Office of the Federal Register (OFR) has regulations concerning incorporation by reference (IBR) at 1 CFR part 51. If the regulations reference a standard, either in general or by name, in another section, IBR approval is required. In order for CMS to require use of standards in § 423.160 by cross citation to 45 CFR 170.205(b), (c), and (u), those standards must be published in full in the
Federal Register
or CFR. Therefore, CMS must incorporate by reference the materials referenced in the proposals in sections II.A.4., II.A.5., and II.A.6. of this rule which cross cite standards in ONC regulations.

For a final rule, agencies must discuss in the preamble to the final rule ways that the materials the agency proposes to incorporate by reference are reasonably available to interested parties or how the agency worked to make the materials reasonably available. Additionally, the preamble to the final rule must summarize the materials. See section II.B.10. of this final rule for summaries of the standards CMS and ONC are incorporating b

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2024-12842. Public record. Not legal advice.