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

Federal RegisterNov 15, 2023

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 401, 405, 417, 422, 423, 455, and 460

Office of the Secretary

45 CFR Part 170

[CMS-4205-P]

RIN 0938-AV24

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

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:

Proposed rule.

SUMMARY:

This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This proposed rule also includes proposals to codify existing sub-regulatory guidance in the Part C and Part D programs.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 5, 2024.

ADDRESSES:

In commenting, please refer to file code CMS-4205-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

Electronically.

You may submit electronic comments on this regulation to

https://www.regulations.gov.

Follow the “Submit a comment” instructions.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4205-P, P.O. Box 8013, Baltimore, MD 21244.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4205-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Carly Medosch, (410) 786-8633—General Questions.

Naseem Tarmohamed, (410) 786-0814—Part C and Cost Plan Issues.

Lucia Patrone, (410) 786-8621—Part D Issues.

Kristy Nishimoto, (206) 615-2367—Beneficiary Enrollment and Appeal Issues.

Kelley Ordonio, (410) 786-3453—Parts C and D Payment Issues.

Hunter Coohill, (720) 853-2804—Enforcement Issues.

Lauren Brandow, (410) 786-9765—PACE Issues.

Sara Klotz, (410) 786-1984—D-SNP Issues.

Joe Strazzire, (410) 786-2775—RADV Audit Appeals Issues.

Alexander Baker, (202) 260-2048—Health IT Standards.

PartCandDStarRatings@cms.hhs.gov

—Parts C and D Star Ratings Issues.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

https://www.regulations.gov.

Follow the search instructions on that website to view public comments. CMS will not post on

Regulations.gov

public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Plain Language Summary:

In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this proposed rule may be found at

https://www.regulations.gov/.

I. Executive Summary

A. Purpose

The primary purpose of this proposed rule is to amend the regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicare cost plan program, and Programs of All-Inclusive Care for the Elderly (PACE). This proposed rule includes a number of new policies that would improve these programs beginning with contract year 2025 and proposes to codify existing Part C and Part D sub-regulatory guidance. Please note that the new marketing and communications policies in this rule are proposed to be applicable for all contract year 2025 marketing and communications, beginning September 30, 2024. This proposed rule also includes revisions to existing regulations in the Risk Adjustment Data Validation (RADV) audit appeals process and the appeals process for quality bonus payment determination that would take effect and apply 60 days after publication of a final rule. Revisions to existing regulations for the use and release of risk adjustment data would also take effect and apply 60 days after publication of a final rule. A limited number of the provisions in this rule are proposed to be applicable beginning with coverage on and after January 1, 2026.

Additionally, this proposed rule would implement certain sections of the following Federal laws related to the Parts C and D programs:

• The Bipartisan Budget Act (BBA) of 2018.

• The Consolidated Appropriations Act (CAA), 2023.

B. Summary of the Major Provisions

1. Improving Access to Behavioral Health Care Providers

We propose regulatory changes that would improve access to behavioral health care by adding certain behavioral health provider specialties to our MA network adequacy standards. Specifically, we propose to add a new facility-specialty type to the existing list of facility-specialty types evaluated as part of our network adequacy reviews. The new facility-specialty type, “Outpatient Behavioral Health,” would be included in network adequacy

evaluations and can include: Marriage and Family Therapists (MFTs), Mental Health Counselors (MHCs), Opioid Treatment Program (OTP) providers, Community Mental Health Centers or other behavioral health and addiction medicine specialists and facilities. MFTs and MHCs will be eligible to enroll in Medicare and start billing for services beginning January 1, 2024, due to the new statutory benefit category established by the Consolidated Appropriations Act (CAA) 2023. We aim to strengthen network adequacy requirements and improve beneficiary access to behavioral health services and providers by expanding our network adequacy requirements for MA organizations.

2. Special Supplemental Benefits for the Chronically Ill (SSBCI)

We are proposing regulatory changes that would help ensure that SSBCI items and services offered are appropriate and improve or maintain the health or overall function of chronically ill enrollees. First, we are proposing to require that an MA organization must be able to demonstrate through relevant acceptable evidence that an item or service offered as SSBCI has a reasonable expectation of improving or maintain the health or overall function of a chronically ill enrollee, and must, by the date on which it submits its bid to CMS, establish a bibliography of this evidence. Second, we are proposing to clarify that an MA plan must follow its written policies based on objective criteria for determining an enrollee's eligibility for an SSBCI when making such eligibility determinations. Third, we are proposing to require that the MA plan document its denials of SSBCI eligibility rather than its approvals. Additionally, we are proposing to codify CMS's authority to review and deny approval of an MA organization's bid if the MA organization has not demonstrated, through relevant acceptable evidence, that its proposed SSBCI has a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee. Finally, we propose to codify CMS's authority to review SSBCI offerings annually for compliance, considering the evidence available at the time. These proposals, if implemented, would better ensure that the benefits offered as SSBCI are reasonably expected to improve health or overall function of the chronically ill enrollee while also guarding against the use of MA rebate dollars for SSBCI that are not supported by evidence.

In addition, we are proposing new policies to protect beneficiaries and improve transparency regarding SSBCI so that beneficiaries are aware that SSBCI are only available to enrollees who meet specific eligibility criteria. We propose to modify and strengthen the current requirements for the SSBCI disclaimer that MA organizations offering SSBCI must use whenever SSBCI are mentioned. Specifically, we propose that the SSBCI disclaimer list the relevant chronic condition(s) the enrollee must have to be eligible for the SSBCI offered by the MA organization. We propose that the MA organization must convey in its SSBCI disclaimer that even if the enrollee has a listed chronic condition, the enrollee may not receive the benefit because other coverage criteria also apply. We also propose to establish specific font and reading pace parameters for the SSBCI disclaimer in print, television, online, social media, radio, other voice-based ads, and outdoor advertising (including billboards). Finally, we propose to clarify that MA organizations must include the SSBCI disclaimer in all marketing and communications materials that mention SSBCI. We believe that imposing these new SSBCI disclaimer requirements will help to ensure that the marketing of and communication about these benefits is not misleading or potentially confusing to enrollees who rely on these materials to make enrollment decisions.

3. Mid-Year Enrollee Notification of Available Supplemental Benefits

In addition, over the past several years, the number of MA plans offering supplemental benefits has increased. The benefits offered are broader in scope and variety and we are seeing an increasing amount of MA rebate dollars directed towards these benefits. At the same time, plans have reported that enrollee utilization of many of these benefits is low. It is not clear whether MA plans are actively encouraging utilization of these benefits by their enrollees. We propose requiring MA plans to notify enrollees mid-year of the unused supplemental benefits available to them. The notice would list any supplemental benefits not utilized by the beneficiary during the first 6 months of the year (1/1 to 6/30). Currently, MA plans are not required to send any communication specific to an enrollee's usage of supplemental benefits which could be an important part of a plan's overall care coordination efforts. This policy aims to educate enrollees on their access to supplemental benefits to encourage greater utilization of these benefits and ensure MA plans are better stewards of the rebate dollars directed towards these benefits.

4. Enhance Guardrails for Agent and Broker Compensation

Section 1851(j) of the Act requires that CMS develop guidelines to ensure that compensation to agents and brokers creates incentives to enroll individuals in MA plans that are intended to best meet their health care needs. To that end, for many years CMS has set upper limits on the amount of compensation agents and brokers can receive for enrolling Medicare beneficiaries into MA and PDP plans. We have learned, however, that many MA and PDP plans, as well as third-party entities with which they contract (such as Field Marketing Organizations (FMOs)) have structured payments to agents and brokers that have the effect of circumventing compensation caps. We also note that that these additional payments appear to be increasing. In this rule, we are proposing to generally prohibit contract terms between MA organizations and agents, brokers or other third party marketing organizations (TPMOs) that may interfere with the agent's or broker's ability to objectively assess and recommend the plan that best fits a beneficiary's health care needs; set a single compensation rate for all plans; revise the scope of items and services included within agent and broker compensation; and eliminate the regulatory framework which currently allows for separate payment to agents and brokers for administrative services. We are also proposing to make conforming edits to the Part D agent broker compensation rules at § 423.2274. Collectively, we believe the impact of these proposed changes will better align with statutory requirements and intent: to ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the plan that best fits a beneficiary's health care needs. Further, such changes align with the Biden-Harris Administration's commitment to promoting fair, open, and competitive markets and ensuring beneficiaries can make fully informed choices among a robust set of health insurance options.

5. Annual Health Equity Analysis of Utilization Management Policies and Procedures

We are proposing regulatory changes to the composition and responsibilities of the Utilization Management (UM) committee. We propose to require that a member of the UM committee have expertise in health equity. We also propose that the UM committee conduct an annual health equity analysis of the use of prior authorization. The proposed

analysis would examine the impact of prior authorization on enrollees with one or more of the following social risk factors (SRFs): (i) receipt of the low-income subsidy or being dually eligible for Medicare and Medicaid (LIS/DE); or (ii) having a disability. To enable a more comprehensive understanding of the impact of prior authorization practices on enrollees with the specified SRFs, the proposed analysis must compare metrics related to the use of prior authorization for enrollees with the specified SRFs to enrollees without the specified SRFs. Finally, we propose to require MA organizations to make the results of the analysis publicly available on their website in a manner that is easily accessible and without barriers.

6. Amendments to Part C and Part D Reporting Requirements

We are proposing to affirm our authority to collect detailed information from MA organizations and Part D plan sponsors under current regulations, in keeping with the Biden-Harris administration's focus on improving transparency and data in Medicare Advantage and Part D. This proposal would lay the groundwork for new data collection to be established through the Paperwork Reduction Act (PRA) process, which would provide advance notice to interested parties and be subject to public comment. An example of increased data collection could be service level data for all initial coverage decisions and plan level appeals, such as decision rationales for items, services, or diagnosis codes to have better line of sight on utilization management and prior authorization practices, among many other issues.

7. Enhance Enrollees' Right To Appeal an MA Plan's Decision To Terminate Coverage for Non-Hospital Provider Services

Beneficiaries enrolled in Traditional Medicare and MA plans have the right to a fast-track appeal by an Independent Review Entity (IRE) when their covered skilled nursing facility (SNF), home health, or comprehensive outpatient rehabilitation facility (CORF) services are being terminated. Currently, Quality Improvement Organizations (QIO) act as the IRE and conduct these reviews. Under current regulations, MA enrollees do not have the same access to QIO review of a fast-track appeal as Traditional Medicare beneficiaries. We are proposing to (1) require the QIO, instead of the MA plan, to review untimely fast-track appeals of an MA plan's decision to terminate services in an HHA, CORF, or SNF; and (2) fully eliminate provision requiring the forfeiture of an enrollee's right to appeal a termination of services decision when they leave the facility. These proposals would bring MA regulations in line with the parallel reviews available to beneficiaries in Traditional Medicare and expand the rights of MA beneficiaries to access the fast-track appeals process.

8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products

Under current policy, Part D sponsors must obtain explicit approval from CMS prior to making a midyear formulary change that removes a reference product and replaces it with a biosimilar biological product other than an interchangeable biological product. If such a change is approved, the Part D sponsor may apply the change only to enrollees who begin therapy after the effective date of the change. In other words, enrollees currently taking the reference product can remain on the reference product until the end of the plan year without having to obtain an exception. To increase access to biosimilar biological products, including interchangeable biological products, in the Part D program, consistent with the Biden-Harris Administration's commitment to competition as outlined in Executive Order (E.O.) 14036: “Promoting Competition in the American Economy,” we previously proposed to permit Part D sponsors either to immediately substitute interchangeable biological products for their reference products and/or to treat such substitutions as changes applicable to all enrollees following 30 days' notice.

As we continue to consider comments received on that proposal, we are now also proposing to add substitutions of biosimilar biological products other than interchangeable biological products to the type of formulary changes that apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day notice. This proposed policy regarding formulary substitution of biosimilar biological products would parallel our current notice policy for formulary changes that cannot take place immediately. Under current § 423.120(b)(5)(i), Part D sponsors must give 30 days' advance notice to affected enrollees before removing or changing the tiered cost-sharing status of a Part D drug, unless, for instance, the formulary change qualifies for an immediate substitution. This proposal would not permit immediate formulary substitution of biosimilar biological products other than interchangeable biological products.

See section III.Q., Changes to an Approved Formulary, of 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,” which appeared in the December 27, 2022

Federal Register

(87 FR 79452) (hereinafter referred to as the December 2022 proposed rule).

9. Increasing the Percentage of Dually Eligible Managed Care Enrollees Who Receive Medicare and Medicaid Services From the Same Organization

We are proposing interconnected proposals to (a) replace the current quarterly special enrollment period (SEP) with a one-time-per month SEP for dually eligible individuals and others enrolled in the Part D low-income subsidy program to elect a standalone PDP, (b) create a new integrated care SEP to allow dually eligible individuals to elect an integrated D-SNP on a monthly basis, (c) limit enrollment in certain D-SNPs to those individuals who are also enrolled in an affiliated Medicaid managed care organization (MCO), and (d) limit the number of D-SNP plan benefit packages an MA organization, its parent organization, or entity that shares a parent organization with the MA organization, can offer in the same service area as an affiliated Medicaid MCO. This proposed rule would increase the percentage of dually eligible MA enrollees who are in plans that are also contracted to cover Medicaid benefits, thereby expanding access to integrated materials, unified appeal processes across Medicare and Medicaid, and continued Medicare services during an appeal. It would also reduce the number of plans overall that can enroll dually eligible individuals outside the annual coordinated election period, thereby reducing the number of plans deploying aggressive marketing tactics toward dually eligible individuals throughout the year.

10. For D-SNP PPOs, Limit Out-of-Network Cost Sharing

We are proposing to limit out-of-network cost sharing for D-SNP preferred provider organizations (PPOs) for specific services. The proposed rule would reduce cost shifting to Medicaid, increase payments to safety net providers, expand dually eligible enrollees' access to providers, and protect dually eligible enrollees from unaffordable costs.

11. Contracting Standards for Dual Eligible Special Needs Plan Look-Alikes

Under existing regulations, CMS does not contract with and will not renew the contract of a D-SNP look-alike—that is, an MA plan that is not a SNP but in which dually eligible enrollees account for 80 percent or more of total enrollment. We are proposing to lower the D-SNP look-alike threshold from 80 percent to 70 percent for plan year 2025 and 60 percent for plan year 2026. This proposal would help address the continued proliferation of MA plans that are serving high percentages of dually eligible individuals without meeting the requirements to be a D-SNP.

12. Standardize the Medicare Advantage (MA) Risk Adjustment Data Validation Appeals Process

We propose regulatory language to address gaps and operational constraints included in existing RADV appeal regulations. Currently, if MA organizations appeal both medical record review determinations and payment error calculations resulting from RADV audits, both issues must be appealed and move through the appeals process concurrently, which we foresee could result in inconsistent appeal adjudications at different levels of appeal that impact recalculations of the payment error. This has the potential to cause burden, confuse MA organizations, and negatively impact the operations and efficiency of CMS's appeals processes. This proposal would standardize and simplify the RADV appeals process for CMS and MA organizations, as well as address operational concerns at all three levels of appeal. We are proposing that MA organizations must exhaust all three levels of appeal for medical record review determinations before beginning the payment error calculation appeals process. This will ensure adjudication of medical record review determinations are final before a recalculation of the payment error is completed and subject to appeal. We also propose several other revisions to our regulatory appeals process to conform with these proposed changes to our procedures.

C. Summary of Costs and Benefits

BILLING CODE 4120-01-P

EP15NO23.006

EP15NO23.007

EP15NO23.008

BILLING CODE 4120-01-C

II. Strengthening Current Medicare Advantage and Medicare Prescription Drug Benefit Program Policies: Past Performance

We established

at §§ 422.502(b) and 423.503(b) that we may deny an application submitted by MA organizations and Part D sponsors that failed to comply with the requirements of a previous MA or Part D contract, which we refer to as “past performance.” We are proposing several technical changes to the regulation text related to past performance. These changes are intended to clarify the basis for application denials due to past performance and to ensure that the factors adequately account for financial difficulties that should prevent an organization from receiving a new or expanded MA or Part D contract.

We previously proposed that would provide Part D sponsors (choosing not to or unable to qualify to make immediate substitutions as proposed) the option to treat substitutions of interchangeable biological products for their reference products as changes applicable to all enrollees requiring 30 days' notice for those currently taking a related reference product. See section III.Q. of the December 2022 proposed rule. These and other proposals discussed in section III.Q. of the December 2022 proposed rule have not been finalized and remain under consideration.

One factor we consider regarding the past performance of MA organizations and Part D sponsors is their record of imposition of intermediate sanctions, because intermediate sanctions represent significant non-compliance with MA or Part D contract requirements. To clarify the basis for application denials due to intermediate sanctions, at §§ 422.502(b)(1)(i)(A) and 423.503(b)(1)(i)(A) we propose to

change “Was subject to the imposition of an intermediate sanction” to “Was under an intermediate sanction.” We are proposing this revision because MA organizations and Part D sponsors may have a sanction imposed in one 12-month past performance review period and effective for all or part of the subsequent 12-month review period. For instance, CMS could impose a sanction in December 2022 that remains in effect until September 2023. The sanction would be in effect for the past performance review period that runs from March 2022 through February 2023 (for Contract Year 2024 MA and Part D applications filed in February 2023) and for the past performance review period that runs from March 2023 through February 2024 (for Contract Year MA and Part D applications filled in February 2024). Our proposal reflects our stated intent to deny applications from MA organizations and Part D sponsors when an active sanction existed during the relevant 12-month review period when we previously codified that intermediate sanctions are a basis for denial of an application from an MA organization or Part D sponsor in “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,” final rule which appeared in the

Federal Register

on January 19, 2021 (86 FR 5864) hereinafter referred to as the “January 2021 final rule.” When we codified this requirement, a commenter requested that sanctions lifted during the 12 months prior to the application denial be excluded from past performance. We responded that “The applying organization will receive credit for resolving the non-compliance that warranted the sanction during the next past performance review period, when, presumably, the organization will not have an active sanction in place at any time during the applicable 12-month review period” (86 FR 6000 through 6001). Since an intermediate sanction may be active during multiple consecutive review periods, our proposed language clarifies that an organization's application may be denied as long as the organization is under sanction, not just during the 12-month review period when the sanction was imposed.

An additional factor we consider regarding the past performance of MA organizations and Part D sponsors is involvement in bankruptcy proceedings. At §§ 422.502(b)(1)(i)(C) and 423.503(b)(1)(i)(C) we propose to incorporate Federal bankruptcy as a basis for application denials due to past performance and to conform the two paragraphs by changing the text to “Filed for or is currently in Federal or State bankruptcy proceedings” from “Filed for or is currently in State bankruptcy proceedings,” at § 422.502(b)(1)(i)(C) and “Filed for or is currently under State bankruptcy proceedings” at § 423.503(b)(1)(i)(C). We codified State bankruptcy as a basis for an application denial for the past performance of an MA or Part D Sponsor in “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” which appeared in the

Federal Register

on May 9, 2022 (87 FR 27704). We codified that requirement because bankruptcy may result in the closure of an organization's operations and entering into a new or expanded contract with such an organization is not in the best interest of the MA or Prescription Drug program or the beneficiaries they serve. This concern is equally applicable to both Federal and State bankruptcy, so we propose to revise the regulation so that applications from MA organizations or Part D sponsors that have filed for or are in State or Federal bankruptcy proceedings may be denied on the basis of past performance.

In addition, we are also proposing to correct two technical issues identified since the final rule was published in May 2022. At § 422.502(b)(1)(i)(B), we propose to change the reference to the requirement to maintain fiscally sound operations from § 422.504(b)(14) to the correct reference at § 422.504(a)(14). We also propose to remove the duplication of § 422.502(b)(1)(i)(A) and (B).

III. Enhancements to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

A. Expanding Network Adequacy Requirements for Behavioral Health

Section 1852(d)(1) of the Act allows an MA organization to select the providers from which an enrollee may receive covered benefits, provided that the MA organization, in addition to meeting other requirements, makes such benefits available and accessible in the service area with promptness and assures continuity in the provision of benefits. Further, our regulation at § 422.112(a), requires that a coordinated care plan maintain a network of appropriate providers that is sufficient to provide adequate access to covered services to meet the needs of the population served. To establish standards for these requirements, CMS codified network adequacy criteria and access standards in the “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program” final rule, which appeared in the

Federal Register

on June 2, 2020 (85 FR 33796), hereinafter referred to as the “June 2020 final rule.” In that final rule, we codified, at § 422.116(b), the list of 27 provider specialty types and 13 facility specialty types subject to CMS network adequacy standards. Further, as part of the “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” published in the

Federal Register

January 12, 2022 (87 FR 1842) proposed rule, hereinafter referred to as the “January 2022 proposed rule,” we solicited comments through a Request for Information (RFI), regarding challenges in building MA behavioral health networks and opportunities for improving access to services. In response to the RFI, stakeholders commented on the importance of ensuring adequate access to behavioral health services for enrollees and suggested expanding network adequacy requirements to include additional behavioral health specialty types. As a result, in the “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” final rule, which appeared in the

Federal Register

on April 12, 2023 (88 FR 22120) hereinafter referred to as the “April 2023 final rule,” CMS finalized the addition of two new specialty types to the provider-specialty types list at § 422.116(b)(1), Clinical Psychology and Clinical Social Work, to be subject to the specific time and distance and minimum provider number requirements used in CMS's network adequacy evaluation.

While our regulation at § 422.116(b)(3) authorizes the removal of a specialty or facility type from the network evaluation criteria for a specific year without rulemaking, CMS did not implement a process in § 422.116 to add

new provider types without rulemaking. In a continued effort to address access to behavioral health services within MA networks, we are proposing to add to the list of provider specialties at § 422.116(b) and add corresponding time and distance standards at § 422.116(d)(2).

In addition to meeting the network adequacy evaluation requirements, MA organizations are required at § 422.112(a) to maintain and consistently monitor their provider networks to ensure they are sufficient to provide adequate access to covered services that meet the needs of enrollees. This also helps MA organizations maintain a complete and accurate health plan provider directory as required under §§ 422.111(b)(3) and 422.120(b). The Health Plan Management System (HPMS) provides MA organizations with access to the “Evaluate my Network” functionality, which allows MA organizations the opportunity to test their provider networks against the evaluation standards in § 422.116 outside of a formal network review. The “Evaluate my Network” functionality provides MA organizations the ability to test their networks using the standards in § 422.116(a)(2) in different scenarios, including at the Plan Benefit Package (PBP) level, to consistently monitor whether their provider networks are meeting the current network adequacy standards. We encourage MA organizations to utilize the HPMS “Evaluate my Network” tool to monitor their PBP-level active provider networks and keep abreast of any network issues that could hinder access to care for enrollees. We also remind MA organizations to report any compliance issues or significant changes in their provider network to their CMS Account Manager.

With the revisions applicable beginning January 1, 2024, MA organizations are required to demonstrate that they meet network adequacy for four behavioral health specialty types: psychiatry, clinical psychology, clinical social work, and inpatient psychiatric facility services. The Consolidated Appropriations Act (CAA), 2023 (Pub. L. 117-328) amended the Act to authorize payment under Medicare Part B for services furnished by a Marriage and Family Therapist (MFT) and by a Mental Health Counselor (MHC), effective January 1, 2024. Specifically, section 4121 of the CAA amends section 1861(s)(2) of the Act by adding a new subparagraph (II) that establishes a new benefit category under Part B for MFT services (as defined in section 1861(lll) of the Act) and MHC services (as defined in section 1861(lll) of the Act). MA organizations are required to cover virtually all Part B covered services. As such, these new services must be covered as defined and furnished, respectively, by MFTs, as defined in section 1861(lll)(2) of the Act, and MHCs, as defined in section 1861(lll)(4) of the Act. As a practical matter, MA organizations need to ensure access to these new Medicare-covered services that can only be provided by these types of individual providers and therefore must contract with these types of providers in order to furnish basic benefits as required by section 1852 of the Act (when furnished by different providers, the services would be supplemental benefits covered by the MA plan.)

In addition, we discussed in the April 2023 final rule, that the responses CMS received to the January 2022 proposed rule RFI emphasized the importance of expanding network adequacy standards to include other outpatient behavioral health physicians and health professionals that treat substance use disorders (SUDs) to better meet behavioral health care needs of enrollees. Medicare fee-for-service claims data for 2020 shows that Opioid Treatment Program (OTP) providers had the largest number of claims for SUD services during that timeframe. At the time of publishing our April 2023 final rule, we indicated that while we were not able to finalize adding a combined specialty type called “Prescribers of Medication for Opioid Use Disorder,” which included OTPs and Medication for Opioid Use Disorder (MOUD) waivered providers to the facility-specialty type list in § 422.116(b)(2) as proposed, we would consider the appropriateness of setting network adequacy standards for OTPs in future rulemaking.

Considering the statutory changes to section 1861 of the Act as mentioned, and our interest in establishing network adequacy standards for SUD providers, CMS is proposing to amend the MA network adequacy requirements to address the new provider types and SUD provider types through a combined behavioral health specialty type to include MFTs, MHCs, OTPs, Community Mental Health Centers and other behavioral health and addiction medicine specialty providers that will help us enhance behavioral health access for enrollees. This is consistent with the explanation in our April 2023 final rule that setting a meaningful access standard for the OTP specialty type would be possible under a combined behavioral health specialty type.

CMS is committed to improving access to behavioral health care services for enrollees in the MA program. The CMS Behavioral Health Strategy,

aims to improve access and quality of mental health care and services, including, access to substance use disorder prevention and treatment services. We propose to extend network adequacy requirements to additional behavioral health and substance use disorder providers and facilities by adding time and distance and minimum provider number requirements for a combined provider category. Specifically, we are proposing to add Outpatient Behavioral Health as a new type of facility-specialty in § 422.116(b)(2) and to add Outpatient Behavioral Health to the time and distance requirements in § 422.116(d)(2). For purposes of network adequacy evaluations under § 422.116, Outpatient Behavioral Health can include, MFTs (as defined in section 1861(lll) of the Act), MHCs (as defined in section 1861(lll) of the Act), OTPs (as defined in section 1861(jjj) of the Act), Community Mental Health Centers (as defined in section 1861(ff)(3)(B) of the Act), or those of the following who regularly furnish or will regularly furnish behavioral health counseling or therapy services, including, but not limited to, psychotherapy or prescription of medication for substance use disorders: physician assistants, nurse practitioners, and clinical nurse specialists (as defined in section 1861(aa)(5) of the Act); addiction medicine physicians; or outpatient mental health and substance use treatment facilities. Per § 422.2, the term “provider” means (1) any individual who is engaged in the delivery of health care services in a State and is licensed or certified by the State to engage in that activity in the State; and (2) any entity that is engaged in the delivery of health care services in a State and is licensed or certified to deliver those services if such licensing or certification is required by State law or regulation. Although we are not using the term “provider” specifically here in listing the type of healthcare professionals that we expect to be available to furnish services in order to count for purposes of the proposed new network evaluation standard, all applicable laws about the practice of medicine and delivery of health care services must be met and specific healthcare professionals must be appropriately licensed or certified to furnish the applicable services.

https://www.cms.gov/cms-behavioral-health-strategy.

We are proposing to add this combined facility-specialty type instead

of adding individual provider-specialty types for a few reasons. First, data from the U.S. Department of Labor, Bureau of Labor Statistics show that currently MFTs and MHCs are generally providing services in outpatient behavioral health settings, such as community mental health centers, substance abuse treatment centers, hospitals, and some private practices.

4 5

These types of clinical settings offer a fuller range of services and usually provide access to additional providers, such as advanced practice nurses and physician assistants who provide counseling and other therapeutic services to individuals with behavioral health conditions; our review of the Place of Service codes recorded on professional claims for behavioral health services in the Medicare FFS program illustrates this. In addition, currently, there are a limited number (if any) claims in the Medicare FFS program from MFTs and MHCs; combining the MFT and MHC provider types into the “Outpatient Behavioral Health” facility type provides time for CMS to develop additional data as FFS claims are submitted by MFTs and MHCs to show patterns of access to these provider types across the country. CMS needs such claims and utilization data to support the development of time and distance standards for these particular provider-specialty types. Finally, categorizing these provider specialties as a facility type is consistent with our practice, under § 422.116, wherein physical therapy (PT), occupational therapy (OT), and speech therapy (ST) providers have traditionally been categorized as facility types, even though care is typically furnished by individual health care providers. These provider types (that is, PT, OT, ST) are reported for network adequacy purposes under facility specialty types on Health Service Delivery (HSD) tables.

Bureau of Labor Statistics, U.S. Department of Labor,

Occupational Outlook Handbook,

Marriage and Family Therapists, at

https://www.bls.gov/ooh/community-and-social-service/marriage-and-family-therapists.htm

(visited

July 03, 2023

Bureau of Labor Statistics, U.S. Department of Labor,

Occupational Outlook Handbook,

Substance Abuse, Behavioral Disorder, and Mental Health Counselors, at

https://www.bls.gov/ooh/community-and-social-service/substance-abuse-behavioral-disorder-and-mental-health-counselors.htm

(visited

July 06, 2023

As mentioned previously, the statutory change under the CAA will allow MFTs and MHCs to bill Medicare directly for services provided beginning January 1, 2024. We acknowledge that these provider types may not always be located in facilities and provide facility-based services. As such, we will continue to monitor the appropriateness of maintaining this proposed new behavioral health specialty type as a facility-specialty type (that is, under § 422.116(b)(2)) for network adequacy review purposes. Similarly, as the list

of OTPs enrolled in Medicare continues to expand, we will continue to monitor whether network adequacy for OTPs is best measured under a combined facility type for the purpose of network adequacy reviews. Thus, we may engage in future rulemaking to revise this requirement if the landscape of providers changes such that access would be best evaluated separately for MFTs, MHCs, or OTPs instead of under the one facility-specialty type we are proposing in this rule. Any related changes would be proposed in future rulemaking. At this time, we are proposing that MA organizations are allowed to include on their facility HSD tables the following: contracted individual practitioners, group practices, or facilities that are applicable under this specialty type. Under this proposal, MA organizations may not submit a single provider, for purposes of meeting more than one of our provider network requirements, for example, they cannot submit a single provider as a psychiatry, clinical social work, or clinical psychologist provider specialty and also as an Outpatient Behavioral Health facility.

https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/opioid-treatment-program-providers.

Our current regulations, at § 422.116(a)(2), specify that an MA plan must meet maximum time and distance standards and contract with a specified minimum number of each provider and facility-specialty type. Therefore, as part of the proposed changes to our list of facility specialty types under § 422.116(b)(2), we are proposing base time and distance standards in each county type for the new specialty type as follows:

EP15NO23.009

In the proposed rule titled “Medicare and Medicaid Programs; Contract Year 2021 and 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

Federal Register

on February 18, 2020 (85 FR 9002) (hereinafter referred to as the “February 2020 proposed rule”), we explained how CMS developed the base time and distance standards and the minimum provider requirements used in § 422.116 (85 FR 9094 through 9103). Further, we explained in the February 2020 proposed rule how CMS determines the minimum number requirement for all provider and facility specialty types, which is now codified in § 422.116(e). We codified at § 422.116(e)(2)(iii) that all facilities, except for acute inpatient hospitals facilities, have a minimum number requirement of one. Because we had previously established paragraph (e)(2)(iii) to refer to all facility types listed in paragraphs (b)(2)(ii) through (xiv) and are proposing to add Outpatient Behavioral Health as a facility type at paragraph (b)(2)(xiv), we are not proposing any revisions to paragraph (e)(2)(iii). We followed the analysis and methodology described in the February 2020 proposed rule to

develop the time and distance standards that we propose to apply to the new behavioral health facility-specialty type described here. However, we utilized updated data, including outpatient facility and professional Part B claims data from August 1, 2021, through July 31, 2022, to inform our proposed standard.

Finally, as we indicated in the April 2023 final rule, Medicare FFS claims data shows that telehealth was the second most common place of service for claims with a primary behavioral health diagnosis in 2020 (88 FR 22170). Per § 422.116(d)(5), MA plans may receive a 10-percentage point credit towards the percentage of beneficiaries that reside within published time and distance standards for certain providers when the plan includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in § 422.135, in its contracted network. Currently, § 422.116(d)(5) specifies 14 specialty types for which the 10-percentage point credit is available. Because we understand from stakeholders who commented on our April 2023 final rule that they were supportive of usage of the 10-percentage point credit for behavioral health specialty types, we also propose to add the new Outpatient Behavioral Health facility-specialty type to the list at § 422.116(d)(5) of the specialty types that that will receive the credit if the MA organization's contracted network of providers includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in § 422.135, for covered services.

We welcome comment on this proposal.

B. Standards for Electronic Prescribing (§ 423.160)

1. Legislative Background

Section 1860D-4(e) of the Act requires the adoption of Part D 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. 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 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. 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 healthcare 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,” 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 Health Insurance Portability and Accountability Act of 1996 (HIPAA) 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 healthcare 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,” which appeared in the May 1, 2020

Federal Register

(85 FR 25679). This resulted in significant impact on both ONC and CMS program resources. See section III.C. of this proposed rule for additional discussion of ONC's proposal and authority. 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 would 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

CMS published a proposed rule, “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

December 27, 2022 (87 FR 79452), in which we proposed updates to the standards to be used by Medicare Part D prescription drug plans for electronic prescribing (e-prescribing). The proposals in the December 2022 proposed rule included a novel approach to updating e-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

rather than the historical approach of adopting e-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 healthcare industry and enforcement challenges for HHS that could result from independent adoption of such standards.

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.

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. See section III.C.5. for additional discussion.

In summary, the proposals in the December 2022 proposed rule included the following:

• Requiring the National Council for Prescription Drug Plans (NCPDP) SCRIPT standard version 2022011, proposed for adoption at 45 CFR 170.205(b), and retiring the current NCPDP SCRIPT standard version 2017071, as the e-prescribing standard for transmitting prescriptions and prescription-related information, medication history, and electronic prior authorization (ePA) transactions using electronic media for covered Part D drugs for Part D eligible individuals. This proposal included a transition period from July 1, 2023 up to January 1, 2025, when either version of the NCPDP SCRIPT standard could be used. The cross citation to 45 CFR 170.205(b) included an expiration date of January 1, 2025 for NCPDP SCRIPT standard version 2017071 meaning that this version would expire for the purposes of HHS use and entities named at § 423.160(a)(1) and (2) could use only NCPDP SCRIPT standard version 2022011 as of that date;

• Requiring the NCPDP Real-Time Prescription Benefit (RTPB) standard version 12, proposed for adoption at 45 CFR 170.205(c), as the standard for prescriber real-time benefit tools (RTBTs) supported by Part D sponsors beginning January 1, 2025; and

• Revising regulatory text referring to standards for eligibility transactions (87 FR 79548) to cross reference standards adopted for electronic eligibility transactions in the HIPAA regulations at 45 CFR 162.1202.

We received 24 comments related to these proposals by the close of the comment period on February 13, 2023. Commenters largely supported the proposals; however, several commenters, including NCPDP, recommended that CMS require use of NCPDP SCRIPT standard version 2023011, rather than NCPDP SCRIPT standard version 2022011. Similarly, NCPDP and other commenters recommended that CMS require NCPDP RTPB standard version 13, rather than NCPDP RTPB standard version 12.

Several commenters expressed concerns about being able to successfully transition to NCPDP SCRIPT standard version 2022011 by January 1, 2025, and requested at least 2 years from publication of a final rule to sunset NCPDP SCRIPT standard version 2017071. Several commenters noted that if the implementation of NCPDP SCRIPT standard version 2022011 (or NCPDP SCRIPT standard version 2023011, as recommended by some commenters) is delayed, the January 1, 2025 compliance deadline for electronic prescribing of controlled substances (EPCS) in long-term care (LTC) facilities, as codified at § 423.160(a)(5), should also be delayed accordingly, since the new versions of the NCPDP SCRIPT standard permit 3-way communication between the prescriber, LTC pharmacy, and LTC facility, enabling EPCS to occur reliably in the LTC setting.

A commenter expressed concern that requiring use of the NCPDP SCRIPT standard imposes a financial barrier for independent pharmacies since NCPDP membership is required to access standards. CMS's requirements at § 423.160(a)(2) do not require that all pharmacies transmit, directly or through an intermediary, prescriptions and prescription-related information using electronic media for Part D drugs for Part D-eligible individuals, but (subject to exemptions in § 423.160(a)(3)) § 423.160(a)(2) does require that when pharmacies do so, they must comply with the Part D electronic prescribing standards. CMS's understanding is that a pharmacy management system vendor or software developer is the entity that incurs the direct costs associated with accessing the code and implementation guide associated with updating standards, not the pharmacy itself. We acknowledge that these costs may be passed on through license fees that the vendor charges to the pharmacy as normal costs of doing business. We are not aware of any open-source standards that could replace the NCPDP standards in the Part D program, but we invite comments on this topic. We also note in section III.C.10. of this proposed rule that interested parties may view materials proposed for incorporation by reference for free by following the instructions provided.

CMS has considered these comments, reviewed NCPDP SCRIPT standard

version 2023011 and NCPDP RTPB standard version 13, and identified areas where we can reorganize the regulatory text in § 423.160. Consequently, CMS is withdrawing all proposals contained in section III.S. Standards for Electronic Prescribing (87 FR 79548) of the December 2022 proposed rule. This approach will allow CMS to incorporate the feedback we received on prior proposals, seek comment on concerns raised in response to prior proposals, add new proposals, reorganize and make 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 III.B.4. through III.B.9. of this proposed rule, the new proposals related to standards for electronic prescribing that we are putting forth encompass the following:

• Requiring use of NCPDP SCRIPT standard version 2023011, proposed for adoption 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. This proposal includes a transition period beginning on the effective date of the final rule during which either version of the NCPDP SCRIPT standard may be used. The transition period would end on January 1, 2027, which is the date that ONC has proposed that NCPDP SCRIPT standard version 2017071 would expire for the purposes of HHS use, as described in section III.C.8.a. of this proposed rule. If finalized as proposed, starting January 1, 2027, NCPDP SCRIPT standard version 2023011 would be the only version of the NCPDP SCRIPT standard available for HHS use and for purposes of the Medicare Part D electronic prescribing program;

• Requiring use of NCPDP RTPB standard version 13 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), and retiring use of NCPDP F&B version 3.0 for transmitting formulary and benefit information between prescribers and Part D sponsors. This proposal includes 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 version 3.0 (currently named in regulation at § 423.160(b)(5)(iii) and proposed to be named at § 423.160(b)(3) consistent with the proposed technical changes in this rule) or NCPDP F&B standard version 60, proposed for adoption at 45 CFR 170.205(u). If finalized as proposed, starting January 1, 2027, only a version of the standard adopted for HHS use at 45 CFR 170.205(u) would be permitted for use in Part D electronic prescription drug program, which would be NCPDP F&B standard version 60 if the proposal in section III.C.8.c. of this rule is finalized as proposed;

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

• 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.

In these proposals, we propose 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 III.C.5. of this proposed rule, and the standards adopted by HHS for electronic transactions under HIPAA. This approach differs 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.

As ONC notes in section III.C.5., independent 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. We believe the proposed approach would mitigate potential compliance challenges for the healthcare industry and enforcement challenges for HHS that could result from independent adoption of such standards or asynchronous rulemaking cycles across programs. CMS invites comment on all aspects of these proposals. We also solicit comment on our proposals to cross-reference ONC regulations adopting NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60. We solicit 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 NCPDP F&B standard version 60 by that date.

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).

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 has 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.

Accordingly, we propose to update § 423.160 to specify where transactions for electronic prescribing, medication history, and ePA are required to utilize the NCPDP SCRIPT standard. The proposal, in conjunction with ONC's proposal as described in section III.C.8.a. of this proposed rule, will allow for a transition period where either NCPDP SCRIPT standard version 2017071 or 2023011 can be used, with exclusive use of NCPDP SCRIPT standard version 2023011 required by January 1, 2027. As described in section III.B.7., we solicit comment on the date by which use of the updated version of this and other standards proposed in this proposed rule would be required, if finalized as proposed.

National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 2023011, April 2023. NCPDP SCRIPT standard implementation guides are available to NCPDP members for free and to non-members for a fee at ncpdp.org. The NCPDP SCRIPT standard version 2023011 implementation guide proposed for incorporation by reference in section III.C.10. of this proposed rule can be viewed by interested parties for free by following the instructions provided in that section.

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.

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As discussed in section III.B.5. of this proposed 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 RTPB standard was available. NCPDP has since developed an RTPB standard. We propose 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.

National Council for Prescription Drug Programs (NCPDP) Real-Time Prescription Benefit Standard, Implementation Guide, Version 13, July 2023. NCPDP RTPB standard implementation guides are available to NCPDP members for free and to non-members for a fee at

ncpdp.org.

The NCPDP RTPB standard version 13 implementation guide proposed for incorporation by reference in section III.C.10. of this proposed rule can be viewed by interested parties for free by following the instructions provided in that section.

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.

14 15

We propose to require use of NCPDP F&B standard version 60, and retire NCPDP F&B standard version 3.0, beginning January 1, 2027, and after a transition period during which either version may be used.

National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit Standard, Implementation Guide, Version 60, April 2023. NCPDP F&B standard implementation guides are available to NCPDP members for free and to non-members for a fee at

ncpdp.org.

The NCPDP F&B standard version 60 implementation guide proposed for incorporation by reference in section III.C.10. of this proposed rule can be viewed by interested parties for free by following the instructions provided in that section.

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

Federal Register

November 9, 2022 (87 FR 67634). We propose 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 anticipate no immediate impact from this proposed change in regulatory language. Our proposal, however, would 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.

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.

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.

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https://standards.ncpdp.org/Our-Process.aspx.

NCPDP University. How Industry Needs Drive Changes in Standards. Accessed August 15, 2023, from

https://member.ncpdp.org

(member-only content).

NCPDP University. Voting: The Life Cycle of Standards Approval. Accessed August 15, 2023, from

https://member.ncpdp.org

(member-only content).

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.

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—

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

• General extensibility;

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 previous 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 (that is, multi-party communication) among prescriber, facility, and pharmacy, which will enable EPCS in the LTC setting.

In its comments on the December 2022 proposed rule,

NCPDP highlighted specific enhancements within NCPDP SCRIPT standard version 2023011 that are not present in NCPDP SCRIPT standard version 2022011, which include:

ncpdp.org.

The NCPDP SCRIPT standard version 2023011 implementation guide proposed for incorporation by reference in section III.C.10. of this proposed rule can be viewed by interested parties for free by following the instructions provided in that section.

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 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 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.

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 propose to list all transactions at § 423.160(b)(1)(i)(V) through (Z). We are proposing 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 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. If finalized as proposed, the transition period will end and exclusive use of NCPDP SCRIPT standard version 2023011 will be required starting January 1, 2027, when NCPDP SCRIPT standard version 2017071 will expire for the purposes of HHS use.

Instead of independently naming the NCPDP SCRIPT standard version 2023011 and incorporating the corresponding implementation guide by

reference at § 423.160(c), we propose at § 423.160(b)(1) to cross reference a standard in 45 CFR 170.205(b). ONC proposes to adopt NCPDP SCRIPT standard version 2023011 in 45 CFR 170.205(b)(2) as described in section III.C.8.a. of this proposed rule. The proposed approach would enable 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 III.C.5. of this proposed rule for additional discussion of this coordination effort.

In its letter to CMS requesting CMS to adopt NCPDP SCRIPT standard version 2022011, NCPDP requested that CMS identify certain transactions for prescriptions for which use of the standard is mandatory.

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 propose to list all transactions associated with the NCPDP SCRIPT standard requirements in one place in the regulation. We propose 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 C-C1.

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

BILLING CODE 4120-01-P

EP15NO23.010

EP15NO23.011

EP15NO23.012

BILLING CODE 4120-01-C

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 C-C1. 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 III.C.8.a. of this proposed rule, NCPDP SCRIPT standard version 2023011 is proposed for adoption at 45 CFR 170.205(b)(2), and NCPDP SCRIPT standard version 2017071 is proposed to expire January 1, 2027, at 45 CFR 170.205(b)(1). Consequently, should we finalize our proposal, use of NCPDP SCRIPT standard version 2023011 for the transactions related to electronic prescribing, medication history, and ePA (proposed at § 423.160(b)(1)(i)(A) through (Z)) will be mandatory starting January 1, 2027, if ONC's proposed adoption of NCPDP SCRIPT version 2023011 and proposed expiration date for NCPDP SCRIPT version 2017071 are adopted as proposed.

Section 4. Business Functions, and Section 5. Transactions. National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 2023011, April 2023. NCPDP SCRIPT standard implementation guides are available to NCPDP members for free and to non-members for a fee at

ncpdp.org

. The NCPDP SCRIPT standard version 2023011 implementation guide proposed for incorporation by reference in section III.C.10. of this proposed rule can be viewed by interested parties for free by following the instructions provided in that section.

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

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

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 are not proposing 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 invite 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 the version or versions 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.

For example, we have been informed that the “GetMessage” transaction described in Table C-C1 is not widely used among prescribers. For this reason, we are reiterating guidance

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.

https://www.healthit.gov/isa/section/pharmacyinteroperability.

Supporting Electronic Prescribing Under Medicare Part D. September 19, 2008.

https://www.hhs.gov/guidance/document/supporting-electronic-prescribing-under-medicare-part-d.

In summary, with respect to changes related to adopting, via cross-reference to ONC proposals in section III.C.8.a., NCPDP SCRIPT standard version 2023011 and retiring NCPDP SCRIPT standard version 2017071, we propose a revised paragraph § 423.160(b)(1) to:

• 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) through (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 in section III.C.8.a., 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 has 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 solicit comment on these proposals.

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

In the May 2019 final rule (84 FR 23832), 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 real-time benefit tools (RTBT) capable of integrating with at least one prescriber's e-prescribing system or electronic health record (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 an 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 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 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 RTPB standard version 12.

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,

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

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

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 additional clarifying coverage information which is not codified;

• Addition of values to the Coverage Restriction Code and data elements to codify information communicated in the Message to 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.

Even though we are withdrawing the proposals contained in section III.S. Standards for Electronic Prescribing in the December 2022 proposed rule (87 FR 79548), we have considered comments we received on the December 2022 proposed rule when crafting our proposals related to RTBTs for this proposed 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 alterative 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 that 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.

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Nevertheless, we seek comment on the issue raised by the commenter. We ask 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.

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.

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.

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.

The NCPDP RTPB standard version 13 standard is designed for prescriber, not beneficiary (that is, consumer), RTBTs. CMS emphasizes that we are not proposing 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 decline to propose a standard for beneficiary RTBTs at this time, however we welcome comments on this topic which we may consider for future rulemaking.

As discussed in section III.C.8.b. of this proposed rule, ONC proposes to adopt the NCPDP RTPB standard version 13 at 45 CFR 170.205(c)(1). We therefore propose 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 solicit comment on these proposals and the related issues raised.

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.

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 existing text of § 423.160(b)(1)(v) and (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.

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:

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.

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 proposed in sections III.B.4. and III.B.5. of this proposed rule, CMS proposes at § 423.160(b)(3) that transmitting 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 proposes to adopt, at 45 CFR 170.205(u)(1), NCPDP F&B standard version 60 as described in section III.C.8.c. of this proposed rule. After January 1, 2027, entities transmitting formulary and benefit information would be required to comply with a standard in 45 CFR 170.205(u) exclusively, if finalized as proposed. Since ONC did not previously adopt NCPDP F&B standard version 3.0, we are maintaining the incorporation by reference of that version in the Part D regulation at § 423.160(c)(1)(i) to permit a transition period where either NCPDP F&B standard version 3.0 or NCPDP F&B version 60 could be used until January 1, 2027.

We solicit comment on these proposals.

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

CMS has 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.

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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.

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

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

CMS routinely receives 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. CMS reminds entities impacted by the proposed regulatory changes that, consistent with § 423.516, CMS is prohibited from imposing new, significant regulatory requirements on Part D sponsors midyear. If the approach proposed in this proposed rule to align CMS's requirements for certain Part D electronic prescribing standards by cross-referencing standards adopted in ONC regulations is finalized, 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. For example, if a final rule containing a provision to update an electronic prescribing standard to a new version were effective May 30, 2024, then CMS would anticipate requiring the new version of the standard by January 1, 2027. This would allow for a 31-month transition period during which either version of a required standard could be used. 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. Using the prior example, we would assume that to avoid implementing the updated version of a standard on January 1, 2027, Part D sponsors would transition to the updated version of the standard by approximately May 30, 2026.

ONC is proposing 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 are proposing 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), respectively, as previously discussed. 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 ask 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. It is expressly outside the scope of this proposed rule, and we do not seek comment on, the compliance date for the proposals in HHS' November 2022 Administrative Simplification proposed rule; however, we ask for comments on the feasibility of updating multiple standards simultaneously.

8. Standards for Eligibility Transactions

We propose 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 67638). We therefore propose 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 must 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 healthcare industry and enforcement challenges for HHS.

Thus, we propose to delete existing § 423.160(b)(3)(i) and (ii) and modify § 423.160(b)(2) (as renumbered per the technical proposals in section III.B.9. of this proposed rule) to require that eligibility transactions must comply with 45 CFR 162.1202.

We solicit comment on these proposals.

9. 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 can 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 regulation. We propose 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 are proposing 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). Section 423.160(a)(3)(ii) was redesignated as § 423.160(a)(3)(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)(3)(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 are proposing to change this back to “recipient.”

Section 423.160(a)(1) and (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 propose to remove it from the text of § 423.160(b)(1). Moreover, § 423.160(b)(1)(i) through (iv) and (b)(2)(i) through (iii) contain long-outdated requirements going back to the start of the electronic prescribing program in Medicare Part D. We propose to delete references to outdated requirements so that the regulation text will 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 would 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) has 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 can group the functions in paragraph (b) according to the standard used for those functions to avoid repetition. Therefore, we propose to combine “Prescriptions, electronic prior authorization, and medication history” at § 423.160(b)(1), which will require the use of the NCPDP SCRIPT standard version or versions as proposed via cross-reference to ONC regulations. We propose to delete § 423.160(b)(4) and (8). The ePA transactions previously listed at § 423.160(b)(8)(i)(A) through (D) are proposed at § 423.160(b)(1)(i)(V) through (Y). We are proposing to delete reference to versions of the NCPDP F&B standard, currently codified at § 423.160(b)(5) introductory text and (b)(5)(i) and (ii), that are no longer applicable. The remaining paragraphs in § 423.160(b) are renumbered such that § 423.160(b)(2) refers to eligibility, § 423.160(b)(3) refers to formulary and benefits, § 423.160(b)(4) refers to provider identifier, and § 423.160(b)(5) refers to real-time benefit tools.

We are proposing to delete standards incorporated by reference at § 423.160(c) that are: no longer applicable (that is, were associated with outdated requirements that we have proposed to delete); are being proposed for incorporation by reference by ONC at 45 CFR 170.299; 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), and (v) are no longer applicable, and we propose to delete them. The standards for eligibility transactions currently incorporated by reference at § 423.160(c)(1)(iii) and (c)(2)(i) and (ii) have already been incorporated by reference by HHS at 45 CFR 162.920. We propose to delete these specified § 423.160(c)(1) and (2) incorporations by reference in light of our proposals in section III.B.8. of this proposed rule to indicate that entities must comply with 45 CFR 162.1202 for eligibility transactions. In section III.B.11. of this proposed rule, we discuss how we propose to renumber the applicable standards currently incorporated by reference and where we propose to incorporate by reference the proposed new versions of standards as discussed in sections III.B.4., III.B.5., and III.B.6. of this proposed rule.

We believe these changes improve the overall readability of the section. With the exception of proposed changes described in sections III.B.4., III.B.5., III.B.6., and III.B.8., we do not intend for technical changes to alter current requirements.

We solicit comment on these proposals.

10. Summary of Standards for Electronic Prescribing Proposals

Sections III.B.4. though III.B.9. of this proposed rule include the following proposals:

• Requiring, via cross-reference to a standard in 45 CFR 170.205(b), use of NCPDP SCRIPT standard version 2023011, which ONC proposes for adoption at 45 CFR 170.205(b)(2), and retiring use of NCPDP SCRIPT standard version 2017071, via the same proposed cross-reference, for communication of a prescription or prescription-related information supported by Part D sponsors. This proposal includes a transition period beginning on the effective date of the final rule when either version of the NCPDP SCRIPT standard may be used. The transition period would end on January 1, 2027, which is the date that ONC has proposed that NCPDP SCRIPT standard version 2017071 would expire for the purposes of HHS use, as described in section III.C.8.a. of this proposed rule. If finalized as proposed, starting January 1, 2027, NCPDP SCRIPT standard version 2023011 would be the only version of the NCPDP SCRIPT standard available for HHS use and for purposes of the Medicare Part D electronic prescribing program;

• Requiring, beginning January 1, 2027, prescriber RTBTs implemented by Part D sponsors to comply with a standard in 45 CFR 170.205(c), where ONC proposes to adopt NCPDP RTPB standard version 13;

• Requiring transmission of formulary and benefit information between prescribers and Medicare Part D sponsors to comply with a standard in 45 CFR 170.205(u), where ONC proposes to adopt NCPDP F&B standard version 60, and retiring use of NCPDP F&B version 3.0 for transmitting formulary and benefit information between prescribers and Part D sponsors. This proposal includes a transition period beginning on the effective date of the final rule and ending January 1, 2027, where entities would be permitted to use either NCPDP F&B version 3.0 (currently named in regulation at § 423.160(b)(5)(iii) and proposed to be named at § 423.160(b)(3) consistent with the proposed technical changes in this rule) or NCPDP F&B standard version 60, proposed for adoption at 45 CFR 170.205(u). If finalized as proposed, starting January 1, 2027, only a version of the standard adopted for HHS use at 45 CFR 170.205(u) would be permitted for use in Part D electronic prescription drug program, which would be NCPDP F&B standard version 60 if the proposal in section III.C.8.c. of this rule is finalized as proposed;

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

• Making multiple technical changes to the regulation text throughout § 423.160 for clarity by removing requirements and incorporations by reference that are no longer applicable or redundant, re-organizing existing requirements, and correcting a technical error. CMS invites comment on all aspects of these proposals, including the proposed date of January 1, 2027, for required use of NCPDP SCRIPT standard version 2023011, NCPDP RTPB standard version 13, and NCPDP F&B standard version 60.

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), 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 III.B.4., III.B.5., and III.B.6. of this proposed rule which cross cite standards in ONC regulations.

For a proposed rule, agencies must discuss in the preamble to the proposed 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 proposed rule must summarize the materials. See also section III.C.10. of this proposed rule for summaries of the standards proposed for incorporation by reference by ONC.

Consistent with those requirements CMS has established procedures to ensure that interested parties can review and inspect relevant materials. The proposals related to the Part D electronic prescribing standards have relied on the following materials which we propose to incorporate by reference where specified:

• NCPDP SCRIPT Standard, Implementation Guide Version 2017071, approved July 28, 2017, which is currently incorporated by reference at § 423.160(c)(1)(vii). We propose to renumber this incorporation by reference as § 423.160(c)(2);

• NCPDP SCRIPT Standard, Implementation Guide Version 2023011, published April 2023, (Approval Date for American National Standards Institute [ANSI]: January 17, 2023). We propose to incorporate by reference at § 423.160(c)(3);

• NCPDP Real-Time Prescription Benefit Standard, Implementation Guide Version 13, published July 2023 (Approval Date for ANSI: May 19, 2022). We propose to incorporate by reference at § 423.160(c);

• NCPDP Formulary and Benefits Standard, Implementation Guide, Version 3, Release 0 (Version 3.0), published April 2012, which is currently incorporated by reference at § 423.160(c)(1)(vi). We propose to renumber this incorporation by reference at § 423.160(c)(1); and

• NCPDP Formulary and Benefit Standard, Implementation Guide Version 60, published April 2023 (Approval Date for ANSI: April 12, 2023). We propose to incorporate by reference at § 423.160(c)(5).

NCPDP members may access these materials through the member portal at

www.ncpdp.org.

Non-NCPDP members may obtain these materials for information purposes by contacting the CMS at 7500 Security Boulevard, Baltimore, Maryland 21244 by calling (410) 786-4132 or (877) 267-2323 (toll free), or emailing

PartDPolicy@cms.hhs.gov.

C. Adoption of Health IT Standards and Incorporation by Reference (45 CFR 170.205 and 170.299)

1. Overview

In this section, ONC proposes to adopt standards for electronic prescribing and related activities on behalf of HHS under the authority in section 3004 of the Public Health Service Act (42 U.S.C. 300jj-14). ONC is proposing these standards for adoption by HHS as part of a nationwide health information technology infrastructure that supports reducing burden and health care costs and improving patient care. ONC proposes to adopt these standards on behalf of HHS in one location within the Code of Federal Regulations for HHS use, including by the Part D Program as proposed in section III.B. of this proposed rule. These proposals reflect a unified approach across the Department to adopt standards for electronic prescribing (e-prescribing) activities that have previously been adopted separately by CMS and ONC under independent authorities. This approach is intended to increase alignment across HHS and reduce regulatory burden for interested parties subject to program requirements that incorporate these standards.

In the Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications” (December 2022 proposed rule), which appeared in the

Federal Register

December 27, 2022 (87 FR 79552 through 79557), we proposed the adoption of NCPDP SCRIPT standard version 2022011 and NCPDP Real-Time Prescription Benefit standard version 13, as well as related proposals. We considered whether to issue a final rule based on that proposed rule, but considering the concerns raised by the commenters regarding which version of the standards to use, we have opted not to do so. Specifically, some commenters recommended adoption of NCPDP SCRIPT standard version 2023011, rather than the proposed NCPDP SCRIPT standard version 2022011. Other commenters recommended adoption of NCPDP RTPB standard version 13, rather than the proposed NCPDP RTPB standard version 12. See additional discussion in section III.B.5. of this rule. Therefore, we are withdrawing the proposals in sections III.T. and III.U. of the December 2022 proposed rule (87 FR 79552 through 79557). We are issuing a series of new proposals in this proposed rule that take into consideration the feedback we received from commenters on the December 2022 proposed rule and further build on these proposals. Additionally, summaries of the standards we propose to adopt and subsequently incorporate by reference in the Code of Federal Regulations can be found below in section III.C.10. of this rule.

2. Statutory Authority

The Health Information Technology for Economic and Clinical Health Act (HITECH Act), Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and created “Title XXX—Health Information Technology and Quality” (Title XXX) to improve health care quality, safety, and efficiency through the promotion of health IT and exchange of electronic health information (EHI). Subsequently, Title IV of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) amended portions of the HITECH Act by modifying or adding certain provisions to the PHSA relating to health IT.

3. Adoption of Standards and Implementation Specifications

Section 3001 of the PHSA directs the National Coordinator for Health Information Technology (National Coordinator) to perform duties in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information. Section 3001(b) of the PHSA establishes a series of core goals for development of a nationwide health information technology infrastructure that—

• Ensures that each patient's health information is secure and protected, in accordance with applicable law;

• Improves health care quality, reduces medical errors, reduces health disparities, and advances the delivery of patient-centered medical care;

• Reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information;

• Provides appropriate information to help guide medical decisions at the time and place of care;

• Ensures the inclusion of meaningful public input in such development of such infrastructure;

• Improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;

• Improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bioterror events and infectious disease outbreaks;

• Facilitates health and clinical research and health care quality;

• Promotes early detection, prevention, and management of chronic diseases;

• Promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in health care services; and

• Improves efforts to reduce health disparities.

Section 3004 of the PHSA identifies a process for the adoption of health IT standards, implementation specifications, and certification criteria, and authorizes the Secretary to adopt such standards, implementation specifications, and certification criteria. As specified in section 3004(a)(1) of the PHSA, the Secretary is required, in consultation with representatives of other relevant Federal agencies, to jointly review standards, implementation specifications, and certification criteria endorsed by the National Coordinator under section 3001(c) of the PHSA and subsequently determine whether to propose the adoption of any grouping of such standards, implementation specifications, or certification criteria. The Secretary is required to publish all determinations in the

Federal Register

Section 3004(b)(3) of the PHSA, which is titled “Subsequent Standards Activity,” provides that the Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent with the schedule published by the Health IT Advisory Committee (HITAC). As noted in the final rule, “2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications,” which appeared in the October 16, 2015

Federal Register

, we consider this provision in the broader context of the HITECH Act and the Cures Act to grant the Secretary the authority and discretion to adopt standards, implementation specifications, and certification criteria that have been recommended by the HITAC and endorsed by the National Coordinator, as well as other appropriate and necessary health IT standards, implementation specifications, and certification criteria (80 FR 62606).

Under the authority outlined in section 3004(b)(3) of the PHSA, the Secretary may adopt standards, implementation specifications, and certification criteria as necessary even if those standards have not been recommended and endorsed through the process established for the HITAC under section 3002(b)(2) and (3) of the PHSA. Moreover, while HHS has traditionally adopted standards and implementation specifications at the same time as adopting certification criteria that reference those standards, the Secretary's authority under section 3004(b)(3) of the PHSA is not limited to adopting standards or implementation specifications at the same time certification criteria are adopted.

Finally, the Cures Act amended the PHSA by adding section 3004(c), which specifies that in adopting and implementing standards under section 3004, the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards bodies.

4. Alignment With Federal Advisory Committee Activities

The HITECH Act established two Federal advisory committees, the HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC). Each was responsible for advising the National Coordinator on different aspects of health IT policy, standards, implementation specifications, and certification criteria.

Section 4003(e) of the Cures Act amended section 3002 of the PHSA and replaced the HITPC and HITSC with one committee, the HITAC. After that change, section 3002(a) of the PHSA establishes that the HITAC advises and recommends to the National Coordinator standards, implementation specifications, and certification criteria relating to the implementation of a health IT infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information. The Cures Act specifically directed the HITAC to advise on two areas: (1) A policy framework to advance an interoperable health information technology infrastructure (section 3002(b)(1) of the PHSA); and (2) priority target areas for standards, implementation specifications, and certification criteria (section 3002(b)(2) of the PHSA).

For the policy framework, as described in section 3002(b)(1)(A) of the PHSA, the Cures Act tasked the HITAC with providing recommendations to the National Coordinator on a policy framework for adoption by the Secretary consistent with the Federal Health IT Strategic Plan under section 3001(c)(3) of the PHSA. In February of 2018, the HITAC made recommendations to the National Coordinator for the initial policy framework

and subsequently published a schedule in the

Federal Register

and an annual report on the work of the HITAC and ONC to implement and evolve that framework.

For the priority target areas for standards, implementation specifications, and certification criteria, section 3002(b)(2)(A) of the PHSA identified that in general, the HITAC would recommend to the National Coordinator, for purposes of adoption under section 3004 of the PHSA, standards, implementation specifications, and certification criteria and an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria. In October of 2019, the HITAC finalized recommendations on priority target areas for standards, implementation specifications, and certification criteria.

HITAC Policy Framework Recommendations, February 21, 2018:

https://www.healthit.gov/sites/default/files/page/2019-07/2018-02-21_HITAC_Policy-Framework_FINAL_508-signed.pdf.

Health Information Technology Advisory Committee (HITAC) Annual Report for Fiscal Year 2019 published March 2, 2020:

https://www.healthit.gov/sites/default/files/page/2020-03/HITAC%20Annual%20Report%20for%20FY19_508.pdf.

HITAC recommendations on priority target areas, October 16, 2019:

https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf.

5. Aligned Approach to Standards Adoption

Historically, the ONC Health IT Certification Program and the Part D Program have maintained complementary policies of aligning health IT certification criteria and associated standards related to electronic prescribing, medication history, and electronic prior authorization for prescriptions. While CMS and ONC have worked closely together to ensure consistent adoption of standards through regulatory actions, we recognize that the practice of different HHS components conducting parallel adoption of the same standards may result in additional regulatory burden and confusion for interested parties. For instance, due to discrepancies between regulatory timelines, adoption of the NCPDP SCRIPT standard version 2017071 in different rules (respectively, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC

Health IT Certification Program final rule (85 FR 25642) and the Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program final rule which appeared in the April 16, 2018

Federal Register

(83 FR 16440)) led to a period where ONC had to exercise special enforcement discretion in the ONC Health IT Certification Program.

Given these concerns, ONC and CMS proposals in the December 2022 proposed rule (87 FR 79552 through 79557) reflected a new approach to alignment of standards under which ONC proposed to adopt and incorporate by reference, on behalf of HHS, the NCPDP SCRIPT standard version 2022011 and the NCPDP RTPB standard version 12 in a single Code of Federal Regulations location at 45 CFR 170.205, where CMS proposed to cross-reference these standards for requirements in the Part D program.

See the archived version of the Certification Companion Guide for the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3):

https://www.healthit.gov/sites/default/files/page/2020-12/b3_ccg.pdf.

For additional discussion of this approach see the December 2022 proposed rule (87 FR 79552 through 79557) and CMS's discussion in sections III.B.3 through III.B.7. of this proposed rule. We note that the proposals in this rule continue to reflect an aligned approach with CMS to adoption of health IT standards for e-prescribing and related purposes. We believe our proposed adoption of these standards in a single CFR location for HHS use will help to address concerns around alignment across HHS programs.

6. Regulatory History

For a summary of past standards adoption activities under section 3004 of the PHSA intended to ensure alignment for electronic prescribing and related activities across the ONC Health IT Certification Program and the Part D Program, we refer readers to the December 2022 proposed rule (87 FR 79553). In this proposed rule, we also propose to adopt the NCPDP Formulary and Benefit (F&B) standard version 60, which was not previously discussed in the December 2022 proposed rule (87 FR 79553). For a summary of previous notice-and-comment rulemaking related to formulary and benefit management capabilities in the ONC Health IT Certification Program, we refer readers to the “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” proposed rule (HTI-1 Proposed Rule) (88 FR 23853 through 23854).

7. Interoperability Standards Advisory

ONC's Interoperability Standards Advisory (ISA) supports the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the health care industry to address specific interoperability needs.

The ISA is updated on an annual basis based on recommendations received from public comments and subject matter expert feedback. This public comment process reflects ongoing dialogue, debate, and consensus among industry interested parties when more than one standard or implementation specification could be used to address a specific interoperability need.

See

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

ONC currently identifies the standards proposed for adoption in this section within the ISA as available standards for a variety of potential use cases. The NCPDP SCRIPT standard version 2023011, the NCPDP Real-Time Prescription Benefit standard version 13, and the NCPDP Formulary and Benefits standard version 60 are currently identified in sections of the ISA including the “Pharmacy Interoperability”

and “Administrative Transactions—Non-Claims.”

We encourage interested parties to review the ISA to better understand key applications for the implementation specifications proposed for adoption in this proposed rule.

See

https://www.healthit.gov/isa/section/pharmacyinteroperability.

See

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

8. Proposal To Adopt Standards for Use by HHS

Consistent with section 3004(b)(3) of the PHSA and the efforts, as previously described, to evaluate and identify standards for adoption, we propose to adopt the following implementation specifications in 45 CFR 170.205(b)(2), (c)(1), and (u)(1), on behalf of the Secretary, to support the continued development of a nationwide health information technology infrastructure as described under section 3001(b) of the PHSA, and to support Federal alignment of standards for interoperability and health information exchange. Specifically, we propose to adopt the following standards:

• NCPDP SCRIPT Standard, Implementation Guide, Version 2023011.

• NCPDP Real-Time Prescription Benefit (RTPB) Standard, Implementation Guide, Version 13.

• NCPDP Formulary and Benefits (F&B) Standard, Implementation Guide, Version 60.

In addition to comments on the individual proposals below, we invite comments on whether there are alternative versions, including any newer versions, of these or other standards that we should consider for adoption for HHS use. In particular, we would be interested in, and would consider for adoption in a final rule, any newer version of the proposed standard(s) that may correct any unidentified errors or clarify ambiguities that would support successful implementation of the standard(s) and the interoperability of health IT.

a. NCPDP SCRIPT Standard Version 2023011 (45 CFR 170.205(b))

ONC has previously adopted three versions of the NCPDP SCRIPT standard in 45 CFR 170.205. Most recently, we adopted NCPDP SCRIPT standard version 2017071 in the ONC 21st Century Cures Act final rule to facilitate the transfer of prescription data among pharmacies, prescribers, and payers (85 FR 25678).

The updated NCPDP SCRIPT standard version 2023011 includes important enhancements relative to NCPDP SCRIPT standard version 2017071. Enhancements have been added to support electronic prior authorization functions as well as electronic transfer of prescriptions between pharmacies. NCPDP SCRIPT standard version 2023011 also includes functionality that supports a 3-way transaction among prescriber, facility, and pharmacy, which will enable electronic prescribing of controlled substances in the long-term care (LTC) setting.

See

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

We propose to adopt NCPDP SCRIPT standard version 2023011 in 45 CFR 170.205(b)(2), replacing NCPDP SCRIPT standard version 10.6 which is currently in 170.205(b)(2). We propose to incorporate NCPDP SCRIPT standard version 2023011 by reference in 45 CFR 170.299. Regarding NCPDP SCRIPT standard version 2017071, we propose to revise the regulatory text in 45 CFR 170.205(b)(1) to specify that adoption of this standard will expire on January 1, 2027. If these proposals are finalized, this would mean that both the 2017071 and 2023011 versions of the NCPDP SCRIPT standard would be available for

HHS use from the effective date of a final rule until January 1, 2027. On and after January 1, 2027, only the 2023011 version of the NCPDP SCRIPT standard would be available for HHS use, for instance, where use of a standard in 45 CFR 170.205(b) is required. We refer readers to section III.B.4. of this proposed rule, where CMS discusses its proposal at § 423.160(b)(1) to require use of a standard in 45 CFR 170.205(b) for communication of a prescription or prescription-related information to fulfill the requirements for prescriptions, electronic prior authorization, and medication history.

We request comment on these proposals.

b. NCPDP Real-Time Prescription Benefit (RTPB) Standard Version 13 (45 CFR 170.205(c))

The NCPDP Real-Time Prescription Benefit standard version 13 enables the exchange of coverage status and estimated patient financial responsibility for a submitted product and pharmacy, and identifies coverage restrictions and alternatives when they exist. See section III.B.5. of this proposed rule for a description of Real-Time Prescription Benefit standard functionality and enhancements of NCPDP Real-Time Prescription Benefit standard version 13 relative to NCPDP Real-Time Prescription Benefit standard version 12.

Our proposal to adopt this standard supports the requirements of Division CC, Title I, Subtitle B, section 119 of the Consolidated Appropriations Act, 2021 (CAA), Public Law 116-260, which required sponsors of Medicare prescription drug plans to implement a real-time benefit tool that meets technical standards named by the Secretary, in consultation with ONC. In addition, section 119(b) of the CAA amended the definition of a “qualified electronic health record” in section 3000(13) of the PHSA to specify that a “qualified electronic health record” must include or be capable of including a real-time benefit tool. ONC intends to address this provision in future rulemaking for the ONC Health IT Certification Program and will ensure alignment with the proposed NCPDP Real-Time Prescription Benefit standard version 13, if finalized, and related proposals in the Part D program where appropriate.

We also note that the HITAC has previously addressed real-time prescription benefit standards, consistent with its statutory role to recommend standards. In 2019, the HITAC accepted the recommendations included in the 2018 report of the Interoperability Priorities Task Force, including recommendations to continue to monitor standards then being developed for real-time prescription benefit transactions, and, when the standards are sufficiently validated, to require EHR vendors to provide functionality that integrates real time patient-specific prescription benefit checking into the prescribing workflow.

In early 2020, the National Committee on Vital and Health Statistics (NCVHS) and HITAC convened another task force, the Intersection of Clinical and Administrative Data (ICAD) Task Force, which was charged with convening industry experts and producing recommendations related to electronic prior authorizations. The task force report was presented to HITAC in November 2020

and discussed the NCPDP Real-Time Prescription Benefit standard as an important tool for addressing administrative transactions around prescribing.

We are proposing in 45 CFR 170.205(c) to add a new section heading “Real-Time Prescription Benefit.” We are also proposing to adopt the NCPDP Real-Time Prescription Benefit standard version 13

in 45 CFR 170.205(c)(1) and to incorporate this standard by reference in 45 CFR 170.299. We refer readers to section III.B.5. of this rule, where CMS proposes at § 423.160(b)(5) to require Part D sponsors' RTBTs to comply with a standard in 45 CFR 170.205(c) by January 1, 2027, to fulfill the requirements for real-time benefit tools. As previously noted, ONC will consider proposals to require use of this standard to support real-time benefit tool functionality in the ONC Health IT Certification Program, consistent with section 119 of the CAA, in future rulemaking.

See

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

We request comment on these proposals.

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

The NCPDP Formulary and Benefit (F&B) standard version 60

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

See

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

We propose to add a new paragraph heading at 45 CFR 170.205(u), “Formulary and benefit.” We propose to adopt the NCPDP Formulary and Benefit standard version 60 at 45 CFR 170.205(u)(1) and to incorporate this standard by reference in 45 CFR 170.299. We refer readers to section III.B.6. of this proposed rule, where CMS proposes at § 423.160(b)(3) to require, by January 1, 2027, use of a standard in 45 CFR 170.205(u) by Part D plan sponsors to fulfill the requirements for exchange of formulary and benefit information with prescribers.

9. ONC Health IT Certification Program

We are not proposing new or revised certification criteria based on the proposed adoption of standards within this rulemaking. We note that section 119 of the CAA does not require ONC to adopt certification criteria for real-time prescription benefit capabilities at the same time as a standard is adopted by HHS. We are therefore proposing to adopt the standard for HHS use and, as previously discussed, ONC would address new or revised certification criteria referencing the standard, if finalized, in separate rulemaking. ONC recently published a Request for Information in the HTI-1 Proposed Rule seeking information related to a real-time prescription benefit criterion (88 FR 23853 through 23854). ONC will continue to collaborate with CMS to ensure that any future proposals in the ONC Health IT Certification Program continue to advance alignment with program requirements under the Part D Program.

We believe the approach reflected in the standards proposals in this proposed rule will support Federal alignment and coordination of Federal activities with adopted standards and implementation specifications for a wide range of systems, use cases, and data types within the broad scope of health information exchange. Historically, State, Federal, and local partners have leveraged the standards adopted by ONC on behalf of HHS to inform program requirements, technical requirements for grants and funding opportunities, and systems implementation for health information

exchange. We believe the adoption of these standards will support HHS partners in setting technical requirements and advancing the use of innovative health IT solutions for electronic prescribing and related activities.

10. Incorporation by Reference (45 CFR 170.299)

The Office of the Federal Register has established requirements for materials (for example, standards and implementation specifications) that agencies propose to incorporate by reference in the Code of Federal Regulations (79 FR 66267; 1 CFR 51.5(a)). Specifically, 1 CFR 51.5(a) requires agencies to discuss, in the preamble of a proposed rule, the ways that the materials it proposes to incorporate by reference are reasonably available to interested parties or how it worked to make those materials reasonably available to interested parties; and summarize, in the preamble of the proposed rule, the material it proposes to incorporate by reference.

To make the materials we intend to incorporate by reference reasonably available, we provide a uniform resource locator (URL) for the standards and implementation specifications. In many cases, these standards and implementation specifications are directly accessible through the URLs provided. In instances where they are not directly available, we note the steps and requirements necessary to gain access to the standard or implementation specification. In most of these instances, access to the standard or implementation specification can be gained through no-cost (monetary) participation, subscription, or membership with the applicable standards developing organization (SDO) or custodial organization. In certain instances, where noted, access requires a fee or paid membership. As an alternative, a copy of the standards may be viewed for free at the U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, 330 C Street SW, Washington, DC 20201. Please call (202) 690-7171 in advance to arrange inspection.

The National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. 3701

et seq.

) and the Office of Management and Budget (OMB) Circular A-119 require the use of, wherever practical, technical standards that are developed or adopted by voluntary consensus standards bodies to carry out policy objectives or activities, with certain exceptions. The NTTAA and OMB Circular A-119 provide exceptions to selecting only standards developed or adopted by voluntary consensus standards bodies, namely when doing so would be inconsistent with applicable law or otherwise impractical. We have followed the NTTAA and OMB Circular A-119 in proposing standards and implementation specifications for adoption, and note that the technical standards proposed for adoption in 45 CFR 170.205 in this proposed rule were developed by NCPDP, which is an ANSI-accredited, not-for-profit membership organization using a consensus-based process for standards development.

As required by 1 CFR 51.5(a), we provide summaries of the standards we propose to adopt and subsequently incorporate by reference in the Code of Federal Regulations. We also provide relevant information about these standards and implementation specifications in the preamble where these standards are proposed for adoption. We propose to revise § 170.299(k) with the following updated standards:

• National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 2023011, April 2023 (Approval Date for ANSI: January 17, 2023)

URL:

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

Access requires registration, a membership fee, a user account, and a license agreement to obtain a copy of the standard.

Summary:

SCRIPT is a standard created to facilitate the transfer of prescription data between pharmacies, prescribers, and payers. The current standard supports transactions regarding new prescriptions, prescription changes, renewal requests, prescription fill status notification, and prescription cancellation. Enhancements have been added for drug utilization review/use (DUR/DUE) alerts and formulary information as well as transactions to relay medication history and for a facility to notify a pharmacy of resident information. Enhancements have been added to support electronic prior authorization functions as well as electronic transfer of prescriptions between pharmacies.

• National Council for Prescription Drug Programs (NCPDP) Real-Time Prescription Benefit Standard, Implementation Guide, Version 13, July 2023 (Approval Date for ANSI: May 19, 2022)

URL:

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

Access requires registration, a membership fee, a user account, and a license agreement to obtain a copy of the standard.

Summary:

The NCPDP Real-Time Prescription Benefit Standard Implementation Guide is intended to meet the industry need within the pharmacy services sector to facilitate the ability for pharmacy benefit payers/processors to communicate to providers and to ensure a consistent implementation of the standard throughout the industry. The Real-Time Prescription Benefit (RTPB) Standard enables the exchange of patient eligibility, product coverage, and benefit financials for a chosen product and pharmacy, and identifies coverage restrictions, and alternatives when they exist.

• National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit Standard, Implementation Guide, Version 60, April 2023 (Approval Date for ANSI: April 12, 2023)

URL:

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

Access requires registration, a membership fee, a user account, and a license agreement to obtain a copy of the standard.

Summary:

The NCPDP Formulary and Benefit Standard Implementation Guide is intended to provide a s

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