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Proposed Rule2023-24118

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

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Published

November 15, 2023

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

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.

Full Text

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<title>Federal Register, Volume 88 Issue 219 (Wednesday, November 15, 2023)</title>
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[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Proposed Rules]
[Pages 78476-78630]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24118]

[[Page 78475]]

Vol. 88

Wednesday,

No. 219

November 15, 2023

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 401, et al.

45 CFR Part 170

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; Proposed Rule

Federal Register / Vol. 88 , No. 219 / Wednesday, November 15, 2023 /
Proposed Rules

[[Page 78476]]

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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.

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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):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. 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.
3. 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.
<a href="/cdn-cgi/l/email-protection#0858697a7c4b69666c4c5b7c697a5a697c61666f7b486b657b2660607b266f677e">[email&#160;protected]</a>--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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> 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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.

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:
<bullet> The Bipartisan Budget Act (BBA) of 2018.
<bullet> 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

[[Page 78477]]

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 Sec. 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

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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.\1\ 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 Sec. 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.
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\1\ 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).
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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.

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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

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BILLING CODE 4120-01-C

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

We established at Sec. Sec. 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.
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\2\ 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.
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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 Sec. Sec. 422.502(b)(1)(i)(A) and 423.503(b)(1)(i)(A) we
propose to

[[Page 78483]]

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 Sec. Sec. 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 Sec. 422.502(b)(1)(i)(C) and ``Filed for
or is currently under State bankruptcy proceedings'' at Sec.
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 Sec.
422.502(b)(1)(i)(B), we propose to change the reference to the
requirement to maintain fiscally sound operations from Sec.
422.504(b)(14) to the correct reference at Sec. 422.504(a)(14). We
also propose to remove the duplication of Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 422.116 to add

[[Page 78484]]

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 Sec.
422.116(b) and add corresponding time and distance standards at Sec.
422.116(d)(2).
In addition to meeting the network adequacy evaluation
requirements, MA organizations are required at Sec. 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 Sec. Sec. 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 Sec. 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 Sec.
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 Sec. 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,\3\ 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 Sec. 422.116(b)(2) and to add
Outpatient Behavioral Health to the time and distance requirements in
Sec. 422.116(d)(2). For purposes of network adequacy evaluations under
Sec. 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 Sec. 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.
---------------------------------------------------------------------------

\3\ <a href="https://www.cms.gov/cms-behavioral-health-strategy">https://www.cms.gov/cms-behavioral-health-strategy</a>.
---------------------------------------------------------------------------

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

[[Page 78485]]

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 Sec. 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.
---------------------------------------------------------------------------

\4\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Marriage and Family Therapists, at
<a href="https://www.bls.gov/ooh/community-and-social-service/marriage-and-family-therapists.htm">https://www.bls.gov/ooh/community-and-social-service/marriage-and-family-therapists.htm</a> (visited July 03, 2023).
\5\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Substance Abuse, Behavioral Disorder,
and Mental Health Counselors, at <a href="https://www.bls.gov/ooh/community-and-social-service/substance-abuse-behavioral-disorder-and-mental-health-counselors.htm">https://www.bls.gov/ooh/community-and-social-service/substance-abuse-behavioral-disorder-and-mental-health-counselors.htm</a> (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 Sec. 422.116(b)(2)) for
network adequacy review purposes. Similarly, as the list \6\ 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.
---------------------------------------------------------------------------

\6\ <a href="https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/opioid-treatment-program-providers">https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/opioid-treatment-program-providers</a>.
---------------------------------------------------------------------------

Our current regulations, at Sec. 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 Sec. 422.116(b)(2), we are proposing base time
and distance standards in each county type for the new specialty type
as follows:
[GRAPHIC] [TIFF OMITTED] TP15NO23.009

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 Sec. 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 Sec. 422.116(e). We codified at Sec.
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

[[Page 78486]]

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 Sec. 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 Sec. 422.135, in its contracted network. Currently, Sec.
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 Sec. 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 Sec. 422.135, for covered services.
We welcome comment on this proposal.

B. Standards for Electronic Prescribing (Sec. 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 Sec.
423.160(a)(5). However, prescribers and dispensers who electronically
transmit and receive prescription and certain other information
regarding covered Part D drugs prescribed for Medicare Part D eligible
beneficiaries, directly or through an intermediary, are required to
comply with any applicable standards that are in effect.
2. Regulatory History
As specified at Sec. 423.160(a)(1), Part D sponsors are required
to support the Part D e-prescribing program transaction standards as
part of their electronic prescription drug programs. Likewise, as
specified at Sec. 423.160(a)(2), prescribers and dispensers that
conduct electronic transactions for covered Part D drugs for Part D
eligible individuals for which a program standard has been adopted must
do so using the adopted standard. Transaction standards are
periodically updated to take new knowledge, technology, and other
considerations into account. As CMS adopted specific versions of the
standards when it initially adopted the foundation and final e-
prescribing standards, there was a need to establish a process by which
the standards could be updated or replaced over time to ensure that the
standards did not hold back progress in the 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 Sec. 423.160(b)(7) the requirement that Part D sponsors adopt an
electronic RTBT capable of integrating with at least one prescriber's
electronic prescribing or electronic health record (EHR) system, but
did not name a standard since no standard had been identified as the
industry standard at the time (84 FR 23851). The electronic standards
for eligibility transactions were codified in the final rule titled
``Medicare and Medicaid Program; Regulatory Provisions to Promote
Program Efficiency, Transparency, and Burden Reduction,'' which
appeared in the May 16, 2012 Federal Register (77 FR 29001), to align
with the applicable 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 Sec. 423.160 (83 FR 16638) in 2018,
which required use of the standard beginning in 2020, led to a period
where ONC had to exercise special enforcement discretion

[[Page 78487]]

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
\7\ 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.\8\
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\7\ 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: <a href="https://www.cms.gov/about-cms/what-we-do/administrative-simplification">https://www.cms.gov/about-cms/what-we-do/administrative-simplification</a>.
\8\ 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:
<bullet> 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 Sec. 423.160(a)(1) and (2) could use only NCPDP
SCRIPT standard version 2022011 as of that date;
<bullet> 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
<bullet> 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 Sec.
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 Sec. 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
Sec. 423.160(a)(3)) Sec. 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

[[Page 78488]]

version 2023011 and NCPDP RTPB standard version 13, and identified
areas where we can reorganize the regulatory text in Sec. 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 Sec. 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:
<bullet> 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;
<bullet> Requiring use of NCPDP RTPB standard version 13 for
prescriber RTBTs implemented by Part D sponsors beginning January 1,
2027;
<bullet> 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 Sec. 423.160(b)(5)(iii) and proposed to be named at
Sec. 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;
<bullet> Cross-referencing standards adopted for eligibility
transactions in HIPAA regulations at 45 CFR 162.1202 for requirements
related to eligibility inquiries; and
<bullet> Making multiple technical changes to the regulation text
throughout Sec. 423.160 by removing requirements and incorporations by
reference that are no longer applicable, re-organizing existing
requirements, and correcting a technical error.
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.\9\ As
ONC notes in section III.C.5., independent adoption of the NCPDP SCRIPT
standard version 2017071 in different rules \10\ 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.
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\9\ 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).
\10\ 21st Century Cures Act: Interoperability, Information
Blocking, and the ONC Health IT Certification Program final rule,
which appeared in the May 1, 2020 Federal Register (85 FR 25642),
and the Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, the Medicare Prescription Drug Benefit Programs, and
the PACE Program final rule, which appeared in the April 16, 2018
Federal Register (83 FR 16440).
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The NCPDP SCRIPT standards are used to exchange information among
prescribers, dispensers, intermediaries, and Medicare prescription drug
plans (PDPs). NCPDP 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.\11\ Accordingly, we propose to update Sec.
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.
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\11\ 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 <a href="http://ncpdp.org">ncpdp.org</a>. 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.
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The NCPDP RTPB standard enables the real-time exchange of patient-
specific eligibility, product coverage (including any restrictions and
alternatives), and estimated cost sharing so prescribers have access to
this information through a RTBT application

[[Page 78489]]

at the point-of-prescribing.12 13 As discussed in section
III.B.5. of this proposed rule, as currently codified at Sec.
423.160(b)(7), CMS requires that Part D sponsors implement one or more
electronic RTBTs that are capable of integrating with at least one
prescriber's electronic prescribing system or electronic health record,
as of January 1, 2021; however, at the time CMS established this
requirement, no single industry 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 Sec. 423.160(b)(5) starting January 1, 2027.
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\12\ 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
<a href="http://ncpdp.org">ncpdp.org</a>. 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.
\13\ Bhardwaj S, Miller SD, Bertram A, Smith K, Merrey J,
Davison A. Implementation and cost validation of a real-time benefit
tool. Am J Manag Care. 2022 Oct 1;28(10):e363-e369. doi: 10.37765/
ajmc.2022.89254.
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The NCPDP F&B standard is a batch standard that provides formulary
and benefit information at the plan level rather than at the patient
level. The NCPDP F&B standard complements other standards utilized for
electronic prescribing, electronic prior authorization, and real-time
prescription benefit applications.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.
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\14\ 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 <a href="http://ncpdp.org">ncpdp.org</a>.
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.
\15\ 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. <a href="https://doi.org/10.1016/j.japh.2023.01.016">https://doi.org/10.1016/j.japh.2023.01.016</a>.
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Eligibility inquiries utilize the NCPDP Telecommunication standard
or Accredited Standards Committee X12N 270/271 inquiry and response
transaction for pharmacy or other health benefits, respectively. The
Part D program has adopted standards based on the HIPAA electronic
transaction standards, which have not been updated for more than a
decade. HHS has proposed updates to the HIPAA electronic transaction
standards for retail pharmacies (87 FR 67638) in the proposed rule
titled ``Administrative Simplification: Modifications of Health
Insurance Portability and Accountability Act of 1996 (HIPAA) National
Council for Prescription Drug Programs (NCPDP) Retail Pharmacy
Standards; and Adoption of Pharmacy Subrogation Standard,''
(hereinafter referred to as ``the November 2022 Administrative
Simplification proposed rule''), which appeared in the Federal Register
November 9, 2022 (87 FR 67634). We propose to update the Part D
regulation at Sec. 423.160(b)(3) to require that eligibility
transactions utilize the applicable standard named as the HIPAA
standard for electronic eligibility transactions at 45 CFR 162.1202.
Since 45 CFR 162.1202 currently identifies the same standards that are
named at Sec. 423.160(b)(3)(i) and (ii), we 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 Sec. 423.160
The NCPDP SCRIPT standard has been the adopted electronic
prescribing standard for transmitting prescriptions and prescription-
related information using electronic media for covered Part D drugs for
Part D eligible individuals since foundation standards were named in
the final rule titled ``Medicare Program; E-Prescribing and the
Prescription Drug Program,'' which appeared in the November 7, 2005
Federal Register (70 FR 67568), at the start of the Part D program. The
NCPDP SCRIPT standard is used to exchange information among
prescribers, dispensers, intermediaries, and Medicare prescription drug
plans. In addition to electronic prescribing, the NCPDP SCRIPT standard
is used in electronic prior authorization (ePA) and medication history
transactions.
Although electronic prescribing is optional for physicians, except
as to Schedule II, III, IV, and V controlled substances that are Part D
drugs prescribed under Part D, and pharmacies, the Medicare Part D
statute and regulations require drug plans participating in the
prescription benefit to support electronic prescribing, and physicians
and pharmacies who elect to transmit prescriptions and related
communications electronically must utilize the adopted standards except
in limited circumstances, as codified at Sec. 423.160(a)(3).
NCPDP's standards development process involves a consensus-based
approach to solve emerging needs of the pharmacy industry or to adapt
NCPDP standards to changes made by other standards development
organizations.\16\ 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.\17\ 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.18 19
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\16\ <a href="https://standards.ncpdp.org/Our-Process.aspx">https://standards.ncpdp.org/Our-Process.aspx</a>.
\17\ NCPDP University. How Industry Needs Drive Changes in
Standards. Accessed August 15, 2023, from <a href="https://member.ncpdp.org">https://member.ncpdp.org</a>
(member-only content).
\18\ NCPDP University. Voting: The Life Cycle of Standards
Approval. Accessed August 15, 2023, from <a href="https://member.ncpdp.org">https://member.ncpdp.org</a>
(member-only content).
\19\ <a href="https://www.ncpdp.org/Membership-diversity.aspx">https://www.ncpdp.org/Membership-diversity.aspx</a>.
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In a letter to CMS dated January 14, 2022, NCPDP requested that CMS
adopt NCPDP SCRIPT standard version 2022011, given the number of
updates and enhancements that had been added to the standard since
NCPDP SCRIPT standard version 2017071 was adopted.\20\ NCPDP summarized
the major enhancements in NCPDP SCRIPT standard version 2022011
relative to the currently required NCPDP SCRIPT standard version
2017071. Those summarized enhancements include--
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\20\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf</a>.
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<bullet> General extensibility; \21\
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\21\ 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: <a href="https://converged.propelsoftware.com/blogs/what-is-extensibility">https://converged.propelsoftware.com/blogs/what-is-extensibility</a>.
---------------------------------------------------------------------------

<bullet> Redesign of the Product/Drug groupings requiring National
Drug Code

[[Page 78490]]

(NDC) for DrugCoded element, but not for NonDrugCoded element;
<bullet> Addition of Observation elements to Risk Evaluation and
Mitigation Strategies (REMS) transactions;
<bullet> Addition of ProhibitRenewalRequest to RxChangeResponse and
RxRenewalResponse;
<bullet> Modification of Structured and Codified Sig Structure
format; and
<bullet> 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.\22\
In its comments on the December 2022 proposed rule,\23\ NCPDP
highlighted specific enhancements within NCPDP SCRIPT standard version
2023011 that are not present in NCPDP SCRIPT standard version 2022011,
which include:
---------------------------------------------------------------------------

\22\ 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 <a href="http://ncpdp.org">ncpdp.org</a>. 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.
\23\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf</a>.
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<bullet> Addition of an optional element in the header for
OtherReferenceNumber for multi-party communication transactions, such
as those in LTC;
<bullet> 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;
<bullet> Addition of a new RequestExpirationDate element to
NewRxRequest, RxChangeRequest, and RxRenewalRequest to notify the
prescriber to not send a response after this date;
<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> 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.
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 for this
proposed rule. For instance, several commenters asked that CMS clearly
indicate that the proposed version of the NCPDP SCRIPT standard will
apply to medication history functions. Several commenters noted that
the regulation text at Sec. 423.160(b)(4)(ii) does not list the NCPDP
SCRIPT standard-specific medication history transactions. Commenters
asked that CMS list the corresponding medication history transactions
(RxHistoryRequest and RxHistoryResponse) in the regulation text so as
to minimize ambiguity. After considering these comments, we propose to
list the RxHistoryRequest and RxHistoryResponse transactions at Sec.
423.160(b)(1)(i)(U) subsequent to our technical reorganization of the
section proposed in section III.B.9. of this rule, rather than list the
transactions under Sec. 423.160(b)(4).
With respect to ePA transactions in the NCPDP SCRIPT standard
currently listed at Sec. 423.160(b)(8)(i)(A) through (D)
(PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse,
PAAppealRequest, PAAppealResponse, PACancelRequest, PACancelResponse)
and a new ePA transaction (PANotification) available in NCPDP SCRIPT
standard version 2023011, we propose to list all transactions at Sec.
423.160(b)(1)(i)(V) through (Z). We are proposing new language at Sec.
423.160(b)(1) to indicate that the transactions listed must comply with
a standard in proposed 45 CFR 170.205(b) ``as applicable to the version
of the standard in use'' since an older version of a standard may not
support the same transactions as the newer version of the standard. For
example, during the proposed transition period where either NCPDP
SCRIPT 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

[[Page 78491]]

reference at Sec. 423.160(c), we propose at Sec. 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.\24\ As
previously mentioned in this preamble, in response to the December 2022
proposed rule, NCPDP and other commenters requested additional
transactions be named in regulation. As part of our proposed
reorganization of Sec. 423.160, we 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 Sec.
423.160(b)(1)(i)(A) through (Z), as described in Table C-C1.
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\24\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf</a>.
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BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP15NO23.010

[[Page 78492]]

[GRAPHIC] [TIFF OMITTED] TP15NO23.011

[[Page 78493]]

[GRAPHIC] [TIFF OMITTED] TP15NO23.012

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 Sec. 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 Sec.
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.
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\25\ 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 <a href="http://ncpdp.org">ncpdp.org</a>. 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.
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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

[[Page 78494]]

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, Sec. 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 Sec. 423.160(b)(1)(i)(A)
through (Z). However, it would not require that all transactions be
utilized if they are not needed or are not relevant to the entity. We
refer readers to ONC's Interoperability Standards Advisory (ISA)
website for descriptions and adoption level of transactions in the
NCPDP SCRIPT standard.\26\ 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 \27\
that the NCPDP SCRIPT standard transactions named are not themselves
mandatory, but rather they are to be used as applicable to the entities
specified at Sec. 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.
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\26\ <a href="https://www.healthit.gov/isa/section/pharmacyinteroperability">https://www.healthit.gov/isa/section/pharmacyinteroperability</a>.
\27\ Supporting Electronic Prescribing Under Medicare Part D.
September 19, 2008. <a href="https://www.hhs.gov/guidance/document/supporting-electronic-prescribing-under-medicare-part-d">https://www.hhs.gov/guidance/document/supporting-electronic-prescribing-under-medicare-part-d</a>.
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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 Sec. 423.160(b)(1) to:
<bullet> Consolidate all transactions for electronic prescribing,
ePA, and medication history for which use of the NCPDP SCRIPT standard
is mandatory at Sec. 423.160(b)(1)(i)(A) through (Z); and
<bullet> 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 Sec. 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.\28\ Subsequently, in
the December 2022 proposed rule, CMS proposed that Part D sponsors'
RTBTs comply with NCPDP RTPB standard version 12. In response

[[Page 78495]]

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,\29\ NCPDP listed enhancements in NCPDP RTPB standard version 13
that improve the information communicated between the payer and the
prescriber. These enhancements include:
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\28\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf</a>.
\29\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf</a>.
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<bullet> Addition of a Coverage Status Message to enable the payer
to communicate at the product level additional clarifying coverage
information which is not codified;
<bullet> 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;
<bullet> 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;
<bullet> Addition of fields to communicate formulary status and
preference level of both submitted and alternative products in order to
clarify pricing; and
<bullet> 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 x 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.30 31 32
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.
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\30\ 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.
\31\ Real-Time Benefit Check: Key Insights and Challenges. May
2021. Accessed January 1, 2023. Available at: <a href="https://www.hmpgloballearningnetwork.com/site/frmc/cover-story/real-time-benefit-check-key-insights-and-challenges">https://www.hmpgloballearningnetwork.com/site/frmc/cover-story/real-time-benefit-check-key-insights-and-challenges</a>.
\32\ American Medical Association. Council on Medical Service.
Access to Health Plan Information regarding Lower-Cost Prescription
Options (Resolution 213-NOV-20). Available from <a href="https://councilreports.ama-assn.org/councilreports/downloadreport?uri=/councilreports/n21_cms_report_2.pdf">https://councilreports.ama-assn.org/councilreports/downloadreport?uri=/councilreports/n21_cms_report_2.pdf</a>.
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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
Sec. 423.128(d)(4). The requirements for the beneficiary RTBT are
discussed in the final rule titled ``Medicare and Medicaid Programs;
Contract Year 2022 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid
Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care
for the Elderly,'' which appeared in the January 19, 2021 Federal
Register (86 FR 5864). We 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 Sec. 423.160(b)(5) to require
that beginning January 1, 2027, Part D sponsors' prescriber RTBT must
comply with a standard in 45 CFR 170.205(c).
We 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

[[Page 78496]]

F&B standard serves as a foundation for other electronic prescribing
functions including ePA, real-time benefit check, and specialty
medication eligibility when used in conjunction with other
standards.\33\ NCPDP F&B standard version 3.0 is required for
transmitting formulary and benefits information between prescribers and
Medicare Part D sponsors, consistent with the existing text of Sec.
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.\34\ A detailed change log was attached
to the letter and is available at the link in the footnote. As
described in the letter, compared with NCPDP F&B standard version 3.0,
NCPDP F&B standard version 60 includes all of the following major
enhancements:
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\33\ Babbrah P, Solomon MR, Stember LA, Hill JW, Weiker M.
Formulary & benefit and real-time pharmacy Benefit: Electronic
standards delivering value to prescribers and pharmacists. J Am
Pharm Assoc (2003). 2023 May-Jun;63(3):725-730. doi: 10.1016/
j.japh.2023.01.016.
\34\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230404-to-CMS-Formulary-and-Benefit-V60-Request.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230404-to-CMS-Formulary-and-Benefit-V60-Request.pdf</a>.
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<bullet> Normalization of all files (lists), which allows for
smaller files and reusability.
<bullet> All files have expiration dates.
<bullet> Redesigned alternative and step medication files to reduce
file sizes and to include support for reason for use (that is,
diagnosis).
<bullet> Step medication files support a more complex step
medication program.
<bullet> Updated coverage files to include support for electronic
prior authorization and specialty drugs.
<bullet> 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 Sec.
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 Sec. 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.35 36 A
commenter on the December 2022 proposed rule requested that CMS either
permit 3 years from a final rule before requiring use of a new or
updated version of a standard, or use enforcement discretion if
requiring use of a new or updated version of a standard less than 3
years from a final rule. CMS will generally aim to provide entities
with at least 2 years from when a final rule is finalized; however, we
qualify that in some cases less time may be provided if determined to
be necessary.
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\35\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2021/20210820_To_CMS_RTPBandFandBStandardsAdoptionRequest.pdf</a>.
\36\ <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2022/202201NCPDP-SCRIPTNextVersionLetter.pdf</a>.
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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 Sec. 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 Sec. 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

[[Page 78497]]

text of Sec. 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 Sec.
423.160(b)(3)(i) and (ii) name the Accredited Standards Committee X12N
270/271-Health Care Eligibility Benefit Inquiry and Response, Version
5010, April 2008, ASC X12N/005010x279 and the NCPDP Telecommunication
Standard Specification, Version D, Release 0 (Version D.0), August
2007, and equivalent NCPDP Batch Standard Batch Implementation Guide,
Version 1, Release 2 (Version 1.2), January 2006 supporting
Telecommunications Standard Implementation Guide, Version D, Release 0
(Version D.0), August 2007. We adopted these standards to align with
those adopted at 45 CFR 162.1202, pursuant to the final rule titled
``Health Insurance Reform; Modifications to the Health Insurance
Portability and Accountability Act (HIPAA) Electronic Transaction
Standards,'' which appeared in the January 16, 2009, Federal Register
(74 FR 3326).
The November 2022 Administrative Simplification proposed rule
proposes to update the HIPAA standards used for eligibility
transactions (87 FR 67638). We therefore propose to update the Part D
regulation by proposing, at Sec. 423.160(b)(2), that eligibility
inquiries and responses between the Part D sponsor and prescribers and
between the Part D sponsor and dispensers 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 Sec. 423.160(b)(3)(i) and (ii), but we believe establishing a
cross-reference would help avoid potential future conflicts and
mitigate potential compliance challenges for the healthcare industry
and enforcement challenges for HHS.
Thus, we propose to delete existing Sec. 423.160(b)(3)(i) and (ii)
and modify Sec. 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 Sec. 423.160
In the spirit of alignment with ONC's approach to adopting
standards, we reviewed Sec. 423.160 in its entirety and identified
areas where we 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 Sec.
423.160(a)(3)(ii)). Additionally, certain exemptions have long since
expired. For example, at Sec. 423.160(a)(3)(iv), entities transmitting
prescriptions or prescription-related information where the prescriber
is required by law to issue a prescription for a patient to a non-
prescribing provider (such as a nursing facility) that in turn forwards
the prescription to a dispenser have not been exempt from using the
SCRIPT standard since November 1, 2014.
We are proposing a correction at Sec. 423.160(a)(3)(iii), where
regulation text refers to prescriptions and prescription-related
information transmitted ``internally when the sender and the
beneficiary are part of the same legal entity.'' The exemption
currently at Sec. 423.160(a)(3)(iii) was previously codified at Sec.
423.160(a)(3)(ii) as ``Entities may use either HL7 messages or the
NCPDP SCRIPT Standard to transmit prescriptions or prescription-related
information internally when the sender and the recipient are part of
the same legal entity . . .'' as finalized in the November 2005 final
rule, which codified the foundation standards for Medicare Part D
electronic prescription drug programs (70 FR 67594). Section
423.160(a)(3)(ii) was redesignated as Sec. 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 Sec.
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 Sec. 423.160(b);
therefore, the language currently at Sec. 423.160(b)(1), ``Entities
described in paragraph (a) of this section must comply with the
following adopted standards for transactions under this section,'' is
redundant. We propose to remove it from the text of Sec.
423.160(b)(1). Moreover, Sec. 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

[[Page 78498]]

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
Sec. 423.160(b)(2), ``Medication history'' at Sec. 423.160(b)(4), and
``Electronic prior authorization'' at Sec. 423.160(b)(8) has resulted
in multiple versions of the NCPDP SCRIPT standard, and relevant
transactions, being repeated in these sections. Because Sec.
423.160(a)(1) and (2) state that the entities listed must comply ``with
the applicable standards in paragraph (b),'' we believe that we 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 Sec. 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 Sec. 423.160(b)(4)
and (8). The ePA transactions previously listed at Sec.
423.160(b)(8)(i)(A) through (D) are proposed at Sec.
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 Sec.
423.160(b)(5) introductory text and (b)(5)(i) and (ii), that are no
longer applicable. The remaining paragraphs in Sec. 423.160(b) are
renumbered such that Sec. 423.160(b)(2) refers to eligibility, Sec.
423.160(b)(3) refers to formulary and benefits, Sec. 423.160(b)(4)
refers to provider identifier, and Sec. 423.160(b)(5) refers to real-
time benefit tools.
We are proposing to delete standards incorporated by reference at
Sec. 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 Sec.
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 Sec. 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 Sec.
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:
<bullet> 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;
<bullet> 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;
<bullet> 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 Sec. 423.160(b)(5)(iii) and proposed
to be named at Sec. 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;
<bullet> Cross-referencing standards adopted for eligibility
transactions in HIPAA regulations at 45 CFR 162.1202 for requirements
related to eligibility inquiries; and
<bullet> Making multiple technical changes to the regulation text
throughout Sec. 423.160 for clarity by removing requirements and
incorporations by reference that are no longer applicable or redundant,
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 Sec. 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.

[[Page 78499]]

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:
<bullet> NCPDP SCRIPT Standard, Implementation Guide Version
2017071, approved July 28, 2017, which is currently incorporated by
reference at Sec. 423.160(c)(1)(vii). We propose to renumber this
incorporation by reference as Sec. 423.160(c)(2);
<bullet> 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 Sec. 423.160(c)(3);
<bullet> 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 Sec.
423.160(c);
<bullet> NCPDP Formulary and Benefits Standard, Implementation
Guide, Version 3, Release 0 (Version 3.0), published April 2012, which
is currently incorporated by reference at Sec. 423.160(c)(1)(vi). We
propose to renumber this incorporation by reference at Sec.
423.160(c)(1); and
<bullet> 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 Sec. 423.160(c)(5).
NCPDP members may access these materials through the member portal
at <a href="http://www.ncpdp.org">www.ncpdp.org</a>. 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 <a href="/cdn-cgi/l/email-protection#b2e2d3c0c6f6e2dddedbd1cbf2d1dfc19cdadac19cd5ddc4">[email&#160;protected]</a>.

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--
<bullet> Ensures that each patient's health information is secure
and protected, in accordance with applicable law;
<bullet> Improves health care quality, reduces medical errors,
reduces health disparities, and advances the delivery of patient-
centered medical care;
<bullet> Reduces health care costs resulting from inefficiency,
medical errors, inappropriate care, duplicative care, and incomplete
information;
<bullet> Provides appropriate information to help guide medical
decisions at the time and place of care;
<bullet> Ensures the inclusion of meaningful public input in such
development of such infrastructure;
<bullet> 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;

[[Page 78500]]

<bullet> 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;
<bullet> Facilitates health and clinical research and health care
quality;
<bullet> Promotes early detection, prevention, and management of
chronic diseases;
<bullet> Promotes a more effective marketplace, greater
competition, greater systems analysis, increased consumer choice, and
improved outcomes in health care services; and
<bullet> 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 \37\ 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.\38\ 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.\39\
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\37\ HITAC Policy Framework Recommendations, February 21, 2018:
<a href="https://www.healthit.gov/sites/default/files/page/2019-07/2018-02-21_HITAC_Policy-Framework_FINAL_508-signed.pdf">https://www.healthit.gov/sites/default/files/page/2019-07/2018-02-21_HITAC_Policy-Framework_FINAL_508-signed.pdf</a>.
\38\ Health Information Technology Advisory Committee (HITAC)
Annual Report for Fiscal Year 2019 published March 2, 2020: <a href="https://www.healthit.gov/sites/default/files/page/2020-03/HITAC%20Annual%20Report%20for%20FY19_508.pdf">https://www.healthit.gov/sites/default/files/page/2020-03/HITAC%20Annual%20Report%20for%20FY19_508.pdf</a>.
\39\ HITAC recommendations on priority target areas, October 16,
2019: <a href="https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf">https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf</a>.
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5. Aligned Approach to Standards Adoption
Historically, the ONC Health IT Certification Program and the Part
D Program have maintained complementary policies of aligning health IT
certification criteria and associated standards related to electronic
prescribing, medication history, and electronic prior authorization for
prescriptions. While CMS and ONC have worked closely together to ensure
consistent adoption of standards through regulatory actions, we
recognize that the practice of different HHS components conducting
parallel adoption of the same standards may result in additional
regulatory burden and confusion for interested parties. For instance,
due to discrepancies between regulatory timelines, adoption of the
NCPDP SCRIPT standard version 2017071 in different rules (respectively,
21st Century Cures Act: Interoperability, Information Blocking, and the
ONC

[[Page 78501]]

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.\40\ 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.
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\40\ See the archived version of the Certification Companion
Guide for the ``electronic prescribing'' certification criterion in
45 CFR 170.315(b)(3): <a href="https://www.healthit.gov/sites/default/files/page/2020-12/b3_ccg.pdf">https://www.healthit.gov/sites/default/files/page/2020-12/b3_ccg.pdf</a>.
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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.\41\
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.
---------------------------------------------------------------------------

\41\ See <a href="https://www.healthit.gov/isa">https://www.healthit.gov/isa</a>.
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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'' \42\
and ``Administrative Transactions--Non-Claims.'' \43\ We encourage
interested parties to review the ISA to better understand key
applications for the implementation specifications proposed for
adoption in this proposed rule.
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\42\ See <a href="https://www.healthit.gov/isa/section/pharmacyinteroperability">https://www.healthit.gov/isa/section/pharmacyinteroperability</a>.
\43\ See <a href="https://www.healthit.gov/isa/section/administrative-transactions-non-claims">https://www.healthit.gov/isa/section/administrative-transactions-non-claims</a>.
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8. Proposal To Adopt Standards for Use by HHS
Consistent with section 3004(b)(3) of the PHSA and the efforts, as
previously described, to evaluate and identify standards for adoption,
we 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:
<bullet> NCPDP SCRIPT Standard, Implementation Guide, Version
2023011.
<bullet> NCPDP Real-Time Prescription Benefit (RTPB) Standard,
Implementation Guide, Version 13.
<bullet> 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.\44\
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\44\ See <a href="https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf">https://standards.ncpdp.org/Standards/media/pdf/Correspondence/2023/20230213_To_CMS_CMS_4201_P_NPRM.pdf</a>.
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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

[[Page 78502]]

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 Sec. 423.160(b)(1) to require use of a standard in 45 CFR
170.205(b) for communication of a prescription or prescription-related
information to fulfill the requirements for prescriptions, electronic
prior authorization, and medication history.
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.\9\ 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 \10\ 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 \45\ 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 Sec. 423.160(b)(5) to require Part D sponsors' RTBTs to
comply with a standard in 45 CFR 170.205(c) by January 1, 2027, to
fulfill the requirements for real-time benefit tools. 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.
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\45\ See <a href="https://standards.ncpdp.org/Access-to-Standards.aspx">https://standards.ncpdp.org/Access-to-Standards.aspx</a>.
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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 \46\
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.
---------------------------------------------------------------------------

\46\ See <a href="https://standards.ncpdp.org/Access-to-Standards.aspx">https://standards.ncpdp.org/Access-to-Standards.aspx</a>.
---------------------------------------------------------------------------

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 Sec.
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

[[Page 78503]]

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 Sec.
170.299(k) with the following updated standards:
<bullet> National Council for Prescription Drug Programs (NCPDP) SCRIPT
Standard, Implementation Guide, Version 2023011, April 2023 (Approval
Date for ANSI: January 17, 2023)
URL: <a href="https://standards.ncpdp.org/Access-to-Standards.aspx">https://standards.ncpdp.org/Access-to-Standards.aspx</a>.
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.
<bullet> 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: <a href="https://standards.ncpdp.org/Access-to-Standards.aspx">https://standards.ncpdp.org/Access-to-Standards.aspx</a>.
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.
<bullet> 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: <a href="https://standards.ncpdp.org/Access-to-Standards.aspx">https://standards.ncpdp.org/Access-to-Standards.aspx</a>.
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 standard means for pharmacy benefit
payers (including health plans and Pharmacy Benefit Managers) to
communicate formulary and benefit information to prescribers via
technology vendor systems.

D. Improvements to Drug Management Programs (Sec. Sec. 423.100 and
423.153)

Section 1860D-4(c)(5)(A) of the Social Security Act (the Act)
requires that Part D sponsors have a drug management program (DMP) for
beneficiaries at risk of abuse or misuse of frequently abused drugs
(FADs), currently defined by CMS as opioids and benzodiazepines. CMS
codified the framework for DMPs at Sec. 423.153(f) in the April 16,
2018 final rule ``Medicare Program; Contract Year 2019 Policy and
Technical Changes to the Medicare Advantage, Medicare Cost Plan,
Medicare Fee-for-Service, the Medicare Prescription Drug Programs, and
the PACE Program'' (83 FR 16440),

[[Page 78504]]

hereafter referred to as the April 2018 final rule.
Under current DMP policy, CMS identifies potential at-risk
beneficiaries (PARBs) who meet the clinical guidelines described at
Sec. 423.153(f)(16), which CMS refers to as the minimum
Overutilization Monitoring System (OMS) criteria. CMS, through the OMS,
reports such beneficiaries to their Part D plans for case management
under their DMP. There are also supplemental clinical guidelines, or
supplemental OMS criteria, which Part D sponsors can apply themselves
to identify additional PARBs. Under Sec. 423.153(f)(2), sponsors are
required to conduct case management for PARBs, which must include
informing the beneficiary's prescribers of their potential risk for
misuse or abuse of FADs and requesting information from the prescribers
relevant to evaluating the beneficiary's risk, including whether they
meet the regulatory definition of exempted beneficiary.
If the sponsor determines through case management that the enrollee
is an at-risk beneficiary (ARB), after notifying the beneficiary in
writing, the sponsor may limit their access to opioids and/or
benzodiazepines to a selected prescriber and/or network pharmacy(ies)
and/or through a beneficiary-specific point-of-sale claim edit, in
accordance with the requirements at Sec. 423.153(f)(3). CMS
regulations at Sec. 423.100 define exempted beneficiary, at-risk
beneficiary, potential at-risk beneficiary, and frequently abused drug.
1. Definition of Exempted Beneficiary Sec. 423.100
Section 1860D-4(c)(5)(C)(ii) of the Act defines an exempted
individual as one who receives hospice care, who is a resident of a
long-term care facility for which frequently abused drugs are dispensed
for residents through a contract with a single pharmacy, or who the
Secretary elects to treat as an exempted individual. At Sec. 423.100
CMS defines an exempted beneficiary as an enrollee being treated for
active cancer-related pain, or has sickle-cell disease, residing in a
long-term care facility, has elected to receive hospice care, or is
receiving palliative or end-of-life care.
The OMS criteria finalized in the April 2018 final rule were
developed to align with available information and guidelines, such as
the Centers for Disease Control and Prevention (CDC) Guideline for
Prescribing Opioids for Chronic Pain (2016 CDC Guideline) issued in
March 2016.\47\ The current policy to exempt beneficiaries with cancer
from DMPs was developed through feedback from interested parties and
alignment with the 2016 CDC Guideline's active cancer treatment
exclusion. Patients within the scope of the 2016 CDC Guideline included
cancer survivors with chronic pain who have completed cancer treatment,
were in clinical remission, and were under cancer surveillance only.
The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for
Pain (2022 CDC Guideline) \48\ expands and updates the 2016 CDC
Guideline to provide evidence-based recommendations for prescribing
opioid pain medication for acute, subacute, and chronic pain for
outpatients aged >=18 years, excluding pain management related to
sickle cell disease, cancer-related pain treatment, palliative care,
and end-of-life care.
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\47\ <a href="https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm">https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm</a>.
\48\ <a href="https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm">https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm</a>.
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In the interest of alignment with the 2022 CDC Guideline regarding
applicability in individuals with cancer, we are proposing to amend the
regulatory definition of ``exempted beneficiary'' at Sec. 423.100 by
replacing the reference to ``active cancer-related pain'' with
``cancer-related pain.'' With this proposal we expand the definition of
exempted beneficiary to more broadly refer to enrollees being treated
for cancer-related pain to include beneficiaries undergoing active
cancer treatment, as well as cancer survivors with chronic pain who
have completed cancer treatment, are in clinical remission, or are
under cancer surveillance only.
2. Drug Management Program Notices: Timing and Exceptions Sec.
423.153(f)(8)
As discussed above, sponsors must provide case management for any
PARB that meets the OMS criteria to determine whether the individual is
an ARB and whether to implement a limitation on their access to FADs.
Under section 1860D-4(c)(5)(B)(i)(I) of the Act, a sponsor must send an
initial and second notice to such beneficiary prior to imposing such
limitation. In the April 2018 final rule (83 FR 16440), CMS adopted
requirements for the initial and second notices at Sec. 423.153(f)(5)
and (6). The initial notice must inform the beneficiary that they have
been identified as a PARB and must include information outlined in
Sec. 423.153(f)(5)(ii). The second notice must inform the beneficiary
that they have been identified as an ARB and of the limitations on the
beneficiary's coverage of FADs, as specified in Sec.
423.153(f)(6)(ii). In the event that, after sending an initial notice,
a sponsor determines that a PARB is not an ARB, a second notice would
not be sent; instead, an alternate second notice would be sent. Though
not required by the Act, CMS codified a requirement at Sec.
423.153(f)(7) to provide an alternate second notice for the purpose of
informing the beneficiary that they are not an ARB and that no
limitation on their coverage of FADs will be implemented under the DMP.
Section 1860D-4(c)(5)(B)(iv) of the Act establishes that sponsors
must send a second notice on a date that is not less than 30 days after
the initial notice. The 30 days allow sufficient time for the
beneficiary to provide information relevant to the sponsor's
determination, including their preferred prescribers and pharmacies.
CMS codified at Sec. 423.153(f)(8) the timing for providing both the
second notice and alternate second notice. Currently, CMS requires
sponsors to send either the second or alternate second notice on a date
not less than 30 days from the date of the initial notice and not more
than the earlier of the date the sponsor makes the determination or 60
days after the date of the initial notice.
Based on program experience during the first several years of DMPs,
we propose to change the timeframe within which a sponsor must provide
an alternate second notice to a beneficiary who is determined to be
exempt from the DMP subsequent to receiving an initial notice.
Specifically, we propose to redesignate existing Sec.
423.153(f)(8)(ii) as Sec. 423.153(f)(8)(iii), and to revise the text
at Sec. 423.153(f)(8)(ii) to specify that, for such exempted
beneficiaries, the sponsor must provide the alternate second notice
within 3 days of determining the beneficiary is exempt, even if that
occurs less than 30 days from the date of the initial notice. In other
words, we propose to remove the requirement that sponsors wait at least
30 days from the date of the initial notice to send the alternate
second notice to exempted beneficiaries.
Through program oversight, including audits of Part D sponsors, CMS
has observed that initial notices are sometimes sent to Part D
enrollees who meet the definition of an exempted beneficiary at Sec.
423.100, often because the sponsor does not have the necessary
information--for example, that the enrollee has a cancer diagnosis or
is receiving palliative care or end-of-life care--at the time the
sponsor sends the initial notice. However, this information may be
provided later by the enrollee or their prescriber in response to the
initial notice. In some cases, sponsors identify exemptions very
quickly after issuing

[[Page 78505]]

the initial notice, prior to 30 days elapsing. Under current CMS
regulations, if a beneficiary meets the definition of an exempted
beneficiary, the beneficiary does not meet the definition of a PARB.
For this reason, exempted beneficiaries cannot be placed in a Part D
sponsor's DMP. Therefore, as stated in the preamble to the April 2018
final rule (83 FR 16455), a sponsor must remove an exempted beneficiary
from a DMP as soon as it reliably learns that the beneficiary is exempt
(whether that be via the beneficiary, their representative, the
facility, a pharmacy, a prescriber, or an internal or external data
source, including an internal claims system). CMS understands that
sponsors may have already been sending alternate second notices after
determining that a beneficiary is exempt, without waiting for 30 days
to elapse. This proposed change would specify that it is required to
send such notices to exempted beneficiaries sooner than 30 days after
the provision of the initial notice.
CMS reminds Part D sponsors that, during their review and during
case management, they are expected to use all available information to
identify whether a PARB is exempt in advance of sending an initial
notice to protect these vulnerable beneficiaries from unnecessary
burden, anxiety, and disruptions in medically necessary drug therapy.
Thorough review of plan records and robust outreach efforts to
prescribers during case management help to minimize the risk that an
exempted beneficiary would receive an initial notice.
On April 20, 2023, CMS released updated DMP guidance.\49\ Sections
8.1 and 8.2.2 of the guidance state that if a sponsor learns that a
beneficiary is exempt after sending an initial notice, the sponsor
should inform the beneficiary that the initial notice is rescinded. If
less than 30 days have passed since the initial notice, a sponsor
should send a Part D Drug Management Program Retraction Notice for
Exempted Beneficiaries. The model retraction notice addresses the
required 30-day timing issue in the current regulation. If this
proposal to require sponsors to provide an alternate second notice to a
beneficiary who is determined to be exempt from the DMP prior to the
required 30 days elapsing since the initial notice is finalized, the
Part D Drug Management Program Retraction Notice for Exempted
Beneficiaries would no longer be used because sponsors would instead
send the alternate second notice. We are not estimating any reduction
of burden for sponsors no longer using the Retraction Notice. The
Retraction Notice was implemented as a temporary solution for Part D
sponsors to use for exempted beneficiaries in place of the alternate
second notice, which had been accounted for in the latest version of
CMS-10141 (OMB control number 0938-0964).
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\49\ <a href="https://www.cms.gov/files/zip/cy-2023-part-d-dmp-guidance-april-20-2023.zip">https://www.cms.gov/files/zip/cy-2023-part-d-dmp-guidance-april-20-2023.zip</a>.
---------------------------------------------------------------------------

We note that sponsors may determine that a PARB is not an ARB prior
to 30 days elapsing for reasons other than the beneficiary being
exempted. However, we believe the current 30-day requirement before a
sponsor may send an alternate second notice in such situations is
important to maintain because it allows the beneficiary and other
prescribers enough time to provide the sponsor with information that
may influence the sponsor's determination.
We propose an additional technical change related to the timeframe
for providing second and alternate second notices. The current
regulation at Sec. 423.153(f)(8)(i) requires that a sponsor provide a
second or alternate second notice not more than the earlier of the date
the sponsor makes the relevant determination or 60 days after the date
of the initial notice. It is critical that beneficiaries receive timely
written notice about changes to their access to Part D drugs, as well
as information about appeal rights, and the second and alternate second
notices are tied to the date of the plan's determination. However, CMS
understands that sponsors may not always be able to issue printed
notices on the exact day they make a determination for a variety of
reasons, such as they made the determination on a day when there is no
USPS mail service, or later in the day after files have been sent to a
print vendor.
Specifically, we propose to add at Sec. 423.153(f)(8)(i)(A) a
window of up to 3 days to allow for printing and mailing the second
notice or alternate second notice. We note a 3-day window would align
with requirements for providing written notice of a standard or
expedited Part D coverage determination after initial oral notice, as
described at Sec. Sec. 423.568(d) and (f) and 423.572(b),
respectively, and is therefore familiar to sponsors. However, unlike
the circumstances covered by those regulatory provisions, sponsors
would not be providing an initial oral notice, as it would be
impracticable to verbally convey the details of a second notice or
alternate second notice to an enrollee. This proposed change would
provide sponsors sufficient time to print and mail the notices while
ensuring that beneficiaries receive timely information about DMP
limitations. Sponsors must continue to issue these notices as soon as
possible when a determination is made, and CMS does not expect that
sponsors will routinely take the maximum amount of time.
We are not proposing to change the requirement in Sec.
423.153(f)(8)(i)(B) that the second notice or alternate second notice
must be provided no later than 60 days from the date of the initial
notice. This is because sponsors have ample time to account in advance
for the days needed to print and mail these notices.
3. OMS Criteria Request for Feedback
CMS regulations at Sec. 423.153(f)(16) specify that PARBs and ARBs
are identified using clinical guidelines that are developed with
stakeholder consultation, derived from expert opinion backed by
analysis of Medicare data, and include a program size estimate. In
addition, the clinical guidelines (also referred to as the ``OMS
criteria'') are based on the acquisition of FADs from multiple
prescribers, multiple pharmacies, the level of FADs used, or any
combination of these factors, or a history of opioid-related overdose.
PARBs are the Part D beneficiaries whom CMS believes are
potentially at the highest risk of opioid-related adverse events or
overdose. The current minimum OMS criteria \50\ identifies PARBs who
(1) use opioids with an average daily morphine milligram equivalents
(MME) of greater or equal to 90 mg for any duration during the most
recent six months, who have received opioids from 3 or more opioid
prescribers and 3 or more opioid dispensing pharmacies, or from 5 or
more opioid prescribers regardless of the number of dispensing
pharmacies (also referred to as ``MIN1'' minimum OMS criteria), or (2)
have a history of opioid-related overdose, with a medical claim with a
primary diagnosis of opioid-related overdose within the most recent 12
months and a Part D opioid prescription (not including Medication for
Opioid Use Disorder \51\ (MOUD)) within the most recent 6 months (also
referred to as ``MIN2'' minimum OMS criteria). The current supplemental
OMS criteria are for sponsors to address plan members who are receiving
opioids from a large number of prescribers or

[[Page 78506]]

pharmacies, but who do not meet a particular MME threshold. These are
(1) use of opioids (regardless of average daily MME) during the most
recent 6 months; AND (2) 7 or more opioid prescribers OR 7 or more
opioid dispensing pharmacies.
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\50\ April 20, 2023 HPMS memorandum, CORRECTION--Contact Year
2023 Drug Management Program Guidance available at: <a href="https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/rxutilization">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/rxutilization</a>.
\51\ Referred to as medication-assisted treatment (MAT) in past
guidance.
---------------------------------------------------------------------------

In 2019, CMS assigned the Health Federally Funded Research and
Development Center (FFRDC) to develop evidence-based recommendations
for improving the OMS criteria for the future. The Health FFRDC
conducted a literature review, facilitated a Technical Expert Panel
(TEP), and performed data analyses. All three activities served as
inputs into the evidence-based recommendations. The Health FFRDC
recommended that the results of the literature review and data analysis
support the continued inclusion of average MME, number of opioid
dispensing pharmacies, and number of opioids prescribers as indicators
for PARBs. In addition, they recommended that further data analysis
would be necessary to determine which additional criteria would be
appropriate to potentially adopt. CMS conducted subsequent literature
reviews and analysis.
In recent years, there has been a marked decrease in Medicare Part
D prescription opioid overutilization, but opioid-related overdose
deaths continue to be a growing problem throughout the United
States.\52\ While the CDC found synthetic opioids (other than
methadone) to be the main driver of opioid overdose deaths, accounting
for 82 percent of all opioid-involved deaths in 2020,\53\ we must
remain vigilant regarding the risks of prescription opioids including
misuse, opioid use disorder (OUD), overdoses, and death. CMS tracks
prevalence rates for Medicare Part D beneficiaries with an OUD \54\
diagnosis and beneficiaries with an opioid poisoning (overdose). While
overall opioid-related overdose prevalence rates among Medicare Part D
enrollees have declined over the period from contract year 2017 through
2021 at about 6.5 percent per annum, overall opioid-related overdose
prevalence rates increased by 1.0 percent between 2020 and 2021.
Furthermore, about 1.6 percent of all Part D enrollees had a provider
diagnosed OUD in contract year 2021 and the OUD prevalence rate has
grown by 3.2 percent per annum since contract year 2017.
---------------------------------------------------------------------------

\52\ Spencer, Merianne R. et al. (2022). Drug Overdose Deaths in
the United States, 2001-2021. (457).
\53\ <a href="https://www.cdc.gov/drugoverdose/deaths/synthetic/index.html">https://www.cdc.gov/drugoverdose/deaths/synthetic/index.html</a>.
\54\ CMS used a modified version of the Chronic Condition
Warehouse (CCW) definition that excludes undiagnosed OUD
beneficiaries such as those with an opioid OD event and also limits
analysis to the particular measurement period instead of the prior
two years.
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A past overdose is the risk factor most predictive for another
overdose or suicide-related event.\55\ CMS finalized regulations to
implement section 2004 of the Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities
(SUPPORT) Act to include beneficiaries with a history of opioid-related
overdose as PARBs in DMPs. While the implementation of the SUPPORT ACT
enables identification of beneficiaries with a history of opioid-
related overdose and continues to identify PARBs who receive high
levels of opioids through multiple providers who may be more likely to
misuse prescription opioids,\56\ CMS is working on models that can
identify beneficiaries potentially at risk before their risk level is
diagnosed as an OUD or the person experiences an opioid-related
overdose.
---------------------------------------------------------------------------

\55\ Bohnert K.M., Ilgen M.A., Louzon S., McCarthy J.F., Katz
I.R., Substance use disorders and the risk of suicide mortality
among men and women in the U.S. Veterans Health Administration.
Addiction. 2017 Jul;112(7):1193-1201. doi: 10.1111/add.13774.
\56\ Over 30,000 Part D enrollees met the minimum OMS criteria
and were reported to sponsors through OMS reports in 2022 (18
percent met the level of opioid use though multiple provider
criteria, and 82 percent met the history of history of opioid-
related overdose criteria).
---------------------------------------------------------------------------

A recently published article that evaluated the use of machine
learning algorithms for predicting opioid overdose risk among Medicare
beneficiaries taking at least one opioid prescription concluded that
the machine learning algorithms appear to perform well for risk
prediction and stratification of opioid overdose especially in
identifying low-risk groups having minimal risk of overdose.\57\
Machine learning is a method of data analysis that automates analytical
model building, based on the idea that systems can learn from data,
identify patterns and make decisions with minimal human intervention.
---------------------------------------------------------------------------

\57\ Lo-Ciganic WH, Huang J.L., Zhang H.H., Weiss J.C., Wu Y.,
Kwoh C.K., Donohue J.M., Cochran G., Gordon A.J., Malone D.C., Kuza
C.C., Gellad W.F. Evaluation of Machine-Learning Algorithms for
Predicting Opioid Overdose Risk Among Medicare Beneficiaries With
Opioid Prescriptions. JAMA Netw Open. 2019 Mar 1;2(3):e190968. doi:
10.1001/jamanetworkopen.2019.0968. Erratum in: JAMA Netw Open. 2019
Jul 3;2(7):e197610. PMID: 30901048; PMCID: PMC6583312.
---------------------------------------------------------------------------

While we are not proposing changes to the clinical guidelines or
OMS criteria in this proposed rule, we provide information on our data
analysis to date and welcome feedback for future changes. Using
predictor variables identified through the literature reviews, CMS
performed a data analysis to determine the top risk factors for Part D
enrollees at high-risk for one of two outcomes: (1) having a new opioid
poisoning (overdose) or (2) developing newly diagnosed OUD. Since Part
D enrollees with a known opioid-related overdose are already identified
in OMS, CMS focused on individuals at high risk for a new opioid-
related overdose or OUD. We anticipate no burden since, as indicated,
we are not proposing regulatory changes and are soliciting feedback.
In this analysis, we utilize Medicare data and traditional logistic
regression as well as machine learning models like Random Forest, Least
Absolute Shrinkage and Selection Operator (LASSO), and Extreme Gradient
Boosting (XGBoost) \58\ Cross Validation (CV) to examine and evaluate
performance in predicting risk of opioid overdose and OUD. The models
were compared based on the following criteria: Area Under the Curve
(AUC), sensitivity, specificity, positive predictive value (PPV),
negative predictive value (NPV), and number needed to examine (NNE). An
XGBoost model with CV performed best according to the specified
criteria and was selected as the model of choice for predicting a
beneficiary with a new opioid overdose or OUD diagnosis.
---------------------------------------------------------------------------

\58\ Extreme Gradient Boosting (XGBoost) model--data mining
technique that is similar to Random Forest that combines multiple
decision trees into a single strong prediction model, but it differs
in doing so in an iterative manner by building one tree at a time
and optimizing a differentiable loss function.
---------------------------------------------------------------------------

The model population included 6,756,152 Medicare beneficiaries
contemporaneously enrolled in Part D and Parts A, B, or C during the
period from January to June 2019, who were prescribed at least one non-
MOUD prescription opioid during the measurement period and did not have
a DMP exemption (that is, cancer, sickle cell disease, hospice, LTC
facility resident, palliative care, or end-of-life care). We excluded
beneficiaries with a prior opioid-related overdose or an OUD diagnosis
in the year prior to the prediction period. The training dataset used
to build the model consisted of a random 75 percent sample of the study
population (5,067,114). The remaining 25 percent of the population
(1,689,038) was used for validating the prediction performance of the
model. The measurement period to obtain information for the predictor
variables (for example, opioid use patterns, demographics,
comorbidities, etc.) was from January 1 to June 30, 2019, and the
prediction period we used to identify beneficiaries with a new opioid

[[Page 78507]]

overdose event or new OUD diagnosis was from July 1 to December 31,
2019.
The following risk factors \59\ were incorporated into the XGBoost
model:
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\59\ Multicollinearity tests were undertaken in order to ensure
that there was no collinearity among the explanatory variables used
in the model.
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BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP15NO23.013

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\60\ The Generic Product Identifier (GPI) designates any or all
of a drug's group, class, sub-class, name, dosage form, and
strength.

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[GRAPHIC] [TIFF OMITTED

[…truncated; see source link]

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Indexed from Federal Register on November 15, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.