Rule2025-15958
Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA), National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Updates to Compliance and Other Related Dates
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2025
Effective
August 20, 2025
Issuing agencies
Health and Human Services Department
Abstract
This document updates compliance and other dates presented in the final rule that appeared in the December 13, 2024 Federal Register 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 Modification of the Medicaid Pharmacy Subrogation Standard" to conform with the subsequent final rule that appeared in the February 11, 2025 Federal Register.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40746-40749]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 162
[CMS-0056-IFR]
RIN 0938-AU19
Administrative Simplification: Modifications of Health Insurance
Portability and Accountability Act of 1996 (HIPAA), National Council
for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and
Modification of the Medicaid Pharmacy Subrogation Standard; Updates to
Compliance and Other Related Dates
AGENCY: Office of the Secretary, Department of Health and Human
Services (HHS).
ACTION: Interim final rule.
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SUMMARY: This document updates compliance and other dates presented in
the final rule that appeared in the December 13, 2024 Federal Register
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 Modification of the Medicaid Pharmacy Subrogation
Standard'' to conform with the subsequent final rule that appeared in
the February 11, 2025 Federal Register.
DATES: These regulations are effective August 20, 2025.
FOR FURTHER INFORMATION CONTACT: Michael Cimmino (410) 786-6408.
SUPPLEMENTARY INFORMATION:
I. Background
We published a final rule that appeared in the December 13, 2024,
Federal Register (89 FR 100763) 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 Modification of the Medicaid Pharmacy
Subrogation Standard,'' (hereinafter referred to as the December 2024
final rule). That final rule adopted updated versions of the retail
pharmacy standards for electronic transactions adopted under the
Administrative Simplification subtitle of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). These updated
versions are modifications to previously adopted standards for the
following retail pharmacy transactions: health care claims or
equivalent encounter information; eligibility for a health plan;
referral certification and authorization; and coordination of benefits.
This final rule also adopted a modification to the standard for the
Medicaid pharmacy subrogation transaction. Subsequently, we determined
this final rule contained a technical error regarding the 8-month
transition period before full compliance with retail pharmacy and
Medicaid pharmacy subrogation standards, so references to August 11,
2027, should have, instead, read June 11, 2027. We published a
subsequent final rule that appeared in the February 11, 2025, Federal
Register (90 FR 9289) 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 Modification of the Medicaid Pharmacy
Subrogation Standard; Delay of Effective Date, (hereinafter referred to
as the
[[Page 40747]]
February 2025 final rule). That final rule delayed by 60 days the
effective date of the December 2024 final rule, to April 14, 2025,
which delay was necessary to give agency officials the opportunity to
further review and consider the new regulation, consistent with the
January 20, 2025, Presidential memorandum titled ``Regulatory Freeze
Pending Review.'' This final rule also mentioned the technical date
error that appeared in the December 2024 final rule.
The February 2025 final rule (90 FR 9290) acknowledged the impact
of this delayed effective date on compliance and transition periods for
covered entities and state Medicaid agencies. The December 2024 final
rule initially specified a compliance date 36 months after its
effective date, with an 8-month transition starting 28 months after the
effective date and running to the compliance date. The February 2025
final rule altered the effective date to April 14, 2025, resulting in a
new compliance date of April 14, 2028, with the 8-month transition
period running from August 14, 2027, to April 14, 2028.
II. Provisions of the Interim Final Rule
This interim final rule (IFR) updates compliance and other dates in
the preamble and regulations text of the December 2024 final rule in
accordance with the delay of effective date changes finalized in the
February 2025 final rule. As a result of the changes published in the
February 2025 final rule, the following provisions of the December 2024
final rule are updated as follows:
<bullet> The Dates section of the December 2024 final rule:
++ Effective Date: April 14, 2025.
++ Compliance Date: April 14, 2028.
<bullet> Summary of effective and compliance dates (section I.C. of
the December 2024 final rule):
++ Beginning August 14, 2027, all covered entities, as agreed to by
trading partners, may use either Version D.0 and Version 1.2, or
Version F6 and Version 15, for 8 months as a transition period prior to
full compliance, which begins 36 months after the effective date of the
February 2025 final rule.
++ All covered entities must be in compliance with Version F6 and
Version 15 beginning April 14, 2028.
++ Beginning August 14, 2027, state Medicaid agencies, as agreed to
by trading partners, may use Version 3.0 or Version 10 for 8 months as
a transition period prior to full compliance, which begins 36 months
after the effective date of the February 2025 final rule.
++ State Medicaid agencies must be in compliance with Version 10
beginning April 14, 2028.
<bullet> Compliance Date for Version F6 and Version 15 (section
III.C.1. of the December 2024 final rule)--The final transition and
compliance dates for Version F6 and Version 15 at Sec. Sec. 162.1102,
162.1202, 162.1302 and 162.1802:
++ All covered entities may, as agreed to by trading partners, use
either Version D.0 and Version 1.2, or Version F6 and Version 15,
beginning August 14, 2027.
++ All covered entities must comply with only Version F6 and
Version 15 beginning April 14, 2028.
<bullet> Compliance Date for Version 10 (section III.C.2. of the
December 2024 final rule)--At Sec. 162.1902, we are finalizing the
compliance date for Version 10 as beginning April 14, 2028, which
aligns with the timeline we are adopting for Version F6 and Version 15.
In addition, at Sec. 162.1902, we are finalizing that, beginning
August 14, 2027, which is 8 months before the compliance date, state
Medicaid agencies may, as agreed to by trading partners, use either
Version 3.0 or Version 10 for Medicaid pharmacy subrogation
transactions.
<bullet> Regulations text of the December 2024 final rule. In the
regulations text of this interim final rule, Sec. Sec. 1162.1102,
162.1202, 162.1302, 162.1802, and 162.1902 are revised to reflect the
transition and compliance dates (August 14, 2027 and April 14, 2028,
respectively) noted previously.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) and (c) of the Administrative Procedure Act
(APA), the agency is required to publish a notice of the proposed
rulemaking in the Federal Register, provide interested parties an
opportunity to comment or otherwise participate in the rulemaking
process, and consider this input prior to finalization. Exceptions to
these requirements are available under section 553(b)(A) and (B) of the
APA when a rule is interpretative, a general statement of policy, or
concerns agency organization, procedure or practice; or when the agency
for good cause finds that notice and comment are impracticable,
unnecessary, or contrary to public interest. In addition, section
553(d) of the APA requires a 30-day delay in effective date after
issuance or publication of a rule, with exceptions available under
sections 553(d)(1) through (d)(3) of the APA that allow the agency to
proceed without the required 30-day delay in effective date where: a
rule grants an exemption or relieves a restriction; a rule is an
interpretative rule or statement of policy; or, otherwise provided by
the agency for good cause with a statement published with the rule.
This interim final rule does not constitute a rule that would be
subject to notice and comment. However, to the extent that 5 U.S.C. 553
applies to this action, it is exempt from its requirements because it
constitutes a general statement of policy under 5 U.S.C. 553(b)(A). As
described previously, the February 2025 final rule's delay in the
effective date was intended to give agency officials the opportunity to
further review and consider the December 2024 final rule. Here, we
simply state the new compliance and other related dates for the
requirements previously finalized in the December 2024 final rule that
arose pursuant to the February 2025 final rule's delay of the effective
date.\1\ This document does not change any of the requirements
previously finalized in the December 2024 final rule, which was the
product of notice and comment rulemaking. The compliance date and
transition period start date for the December 2024 final rule
requirements remain unchanged at, respectively, 36 months and 28 months
from the effective date of the rule; this document states those dates
taking into account the delay in the effective date published in the
February 2025 final rule.
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\1\ As we noted in the February 2025 final rule at 90 FR 5290,
the December 2024 final rule, in the regulations text, contained a
technical error pertaining to the 8-month transition period
(erroneously allowing just a 6-month period), so references to
August 11, 2027 should have read June 11, 2027.
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Moreover, even if this were a rule to which the notice and comment
procedures and delayed effective date requirements applied, we find
that there is good cause to waive such requirements. Undertaking
further notice and comment procedures just to incorporate the updated
dates in this document, or further delaying the effective date, would
be contrary to the public interest, as covered entities have requested
that the updated dates be published in a timely manner in order to
reduce confusion among the industry regarding the actual compliance and
transition period dates. Additional notice and comment procedures and
further delay in the effective date of this interim final rule are
unnecessary as we are not altering our policies, but, rather, simply
stating the updated compliance and other dates that had previously been
proposed and subjected to notice and comment, and then finalized in the
December 2024 final rule. We find that, should the notice, comment, and
effective date requirements have been
[[Page 40748]]
applicable, we have good cause to waive these requirements because they
are unnecessary and contrary to the public interest.
IV. Collection of Information Requirements
This document does not impose new information collection
requirements, that is, reporting, recordkeeping or third-party
disclosure requirements. Consequently, there is no need for review by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
The requirements and burdens associated with the information
collection requirements contained and were finalized in the December
2024 final rule. Therefore, the one-time burden was previously approved
and accounted for in the information collection request previously
approved under OMB control number 0938-0866 and titled ``CMS-R-218:
HIPAA Standards for Coding Electronic Transactions.''
OMB has determined that the establishment of standards for
electronic transactions under HIPAA (which mandate that the private
sector disclose information and do so in a particular format)
constitutes an agency-sponsored third-party disclosure as defined under
the Paperwork Reduction Act (PRA, 44 U.S.C. 3501 et seq.) (see 65 FR
50350 (August 17, 2000)). OMB's previous determination for electronic
transaction standards under HIPAA obviates the need for further OMB
review under the PRA. This document merely finalizes updates in the
compliance and other dates for requirements previously finalized in the
December 2024 final rule to conform with the delayed effective date
published in the February 11, 2025, final rule, and, therefore does not
implicate the PRA.
Should our assumptions be incorrect, this information collection
request will be revised and reinstated to incorporate any additional
transaction standards and modifications to transaction standards that
were previously covered in the PRA package associated with OMB approval
number 0938-0866.
V. Regulatory Impact Statement
A. Statement of Need
As discussed in more detail in section II. of this interim final
rule, consistent with the Presidential memorandum of January 20, 2025,
``Regulatory Freeze Pending Review,'' we delayed for 60 days the
effective date of the December 2024 final rule to provide the
Administration sufficient time to review any questions of fact, law,
and policy. This interim final rule updates compliance and other dates
in the preamble and regulations text of the December 2024 final rule in
accordance with the delay of effective date changes finalized in the
February 2025 final rule.\2\
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\2\ See footnote 1; this interim final rule specifies the
correct transition dates, accounting for the delayed effective date,
and corrects the technical error in their calculation in the
December 2024 final rule regulations text that erroneously provided
a 6-, not 8-, month transition period.
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B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866, ``Regulatory Planning and Review''; Executive Order 13563,
``Improving Regulation and Regulatory Review''; Executive Order 14192,
``Unleashing Prosperity Through Deregulation''; the Regulatory
Flexibility Act (Pub. L. 96 354); section 1102(b) of the Social
Security Act; section 202 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4); Executive Order 13132, ``Federalism''; and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and other advantages, and distributive impacts). Section 3(f)
of Executive Order 12866 defines a ``significant regulatory action'' as
an action that is likely to result in a rule that may: (1) have an
annual effect on the economy of $200 million or more in any one year,
or adversely affect in a material way the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues for arising out of legal mandates, or the President's
priorities.
This interim final rule is not a significant regulatory action
under section 3(f) of Executive Order 12866. The temporary delay in the
effective date until April 14, 2025, published in the February 2025
final rule (90 FR 9290), was necessary to give agency officials the
opportunity for further review and consideration of the new regulation,
consistent with the memorandum described previously. We estimate this
temporary delay in the effective date could result in annualized net
cost savings for the industry of approximately $992,500 and $1.04
million at the 7 percent and 3 percent discount rates, respectively.
Additional details regarding the economic impacts can be found in the
regulatory impact analysis in section VI. of the December 2024 final
rule (89 FR 100773 through 100787).
C. Regulatory Flexibility Act Analysis (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Individuals and states are not included in
the definition of a small entity.
As stated earlier, this interim final rule updates compliance and
other dates in the preamble and regulations text of the December 2024
final rule in accordance with the 60-day delay of effective date
changes finalized in the February 2025 final rule. The temporary delay
in the effective date until April 14, 2025, published in the February
2025 final rule (90 FR 9290), was necessary to give agency officials
the opportunity for further review and consideration of the new
regulation, consistent with the memorandum described previously. As a
result, the Secretary has certified that this interim final rule will
not have a significant impact on a substantial number of small
entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have significant impact on the
operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
the purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This interim final rule
will not significantly impact the operations of a substantial number of
small rural hospitals, as these entities are not involved in the
exchange of retail pharmacy transactions. Therefore, the Secretary has
certified that this interim final rule will not have a significant
impact on the operations of a substantial number of small rural
hospitals.
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D. Unfunded Mandates Reform Act of 1995
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates would require spending more in any 1
year than threshold amounts in 1995 dollars, updated annually for
inflation. In 2025, that threshold is approximately $187 million. This
interim final rule does not contain mandates that will impose spending
costs on State, local, or tribal governments in the aggregate, or by
the private sector, of more than $187 million in any 1 year.
E. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This interim final rule will not impose substantial
direct requirement costs on State and local governments, preempt State
law, or otherwise have Federalism implications.
F. Executive Order 14192
Executive Order 14192, titled ``Unleashing Prosperity Through
Deregulation,'' was issued on January 31, 2025, and requires that ``any
new incremental costs associated with new regulations shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This interim final
rule is expected to be an E.O. 14192 deregulatory action. We estimate
that this interim final rule would generate $992,500 in annualized cost
savings at a 7 percent discount rate, discounted relative to the year
2024, over a perpetual time horizon.
List of Subjects in 45 CFR Part 162
Administrative practice and procedures, Electronic transactions,
Health facilities, Health insurance, Hospitals, Incorporation by
reference, Medicaid, Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Department of Health
and Human Services amends 45 CFR part 162 as set forth below:
PART 162--ADMINISTRATIVE REQUIREMENTS
0
1. The authority citation for part 162 continues to read as follows:
Authority: 42 U.S.C. 1320d--1320d-9 and secs. 1104 and 10109 of
Pub. L. 111-148, 124 Stat. 146-154 and 915-917.
Sec. 162.1102 [Amended]
0
2. Section 162.1102 is amended by:
0
a. In paragraph (c), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
b. In paragraph (d), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
c. In paragraph (e) introductory text, removing the dates ``August 11,
2027 through February 11, 2028,'' and adding in its place the dates
``August 14, 2027 through April 14, 2028,''; and
0
d. In paragraph (f), removing the date ``February 11, 2028'' and adding
in its place the date ``April 14, 2028,''.
Sec. 162.1202 [Amended]
0
3. Section 162.1202 is amended by:
0
a. In paragraph (c), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
b. In paragraph (d) introductory text, removing the dates ``August 11,
2027 through February 11, 2028,'' and adding in its place the dates
``August 14, 2027 through April 14, 2028,''; and
0
c. In paragraph (e), removing the date ``February 11, 2028'' and adding
in its place the date ``April 14, 2028,''.
Sec. 162.1302 [Amended]
0
4. Section 162.1302 is amended by:
0
a. In paragraph (c), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
b. In paragraph (d), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
c. In paragraph (e) introductory text, removing the dates ``August 11,
2027 through February 11, 2028,'' and adding in its place the dates
``August 14, 2027 through April 14, 2028,''; and
0
d. In paragraph (f), removing the date ``February 11, 2028'' and adding
in its place the date ``April 14, 2028,''.
Sec. 162.1802 [Amended]
0
5. Amend Sec. 162.1802 by:
0
a. In paragraph (c), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
b. In paragraph (d), removing the date ``August 11, 2027,'' and adding
in its place the date ``August 14, 2027,'';
0
c. In paragraph (e) introductory text, removing the dates ``August 11,
2027 through February 11, 2028,'' and adding in its place the dates
``August 14, 2027 through April 14, 2028,'';
0
d. In paragraph (f), removing the date ``February 11, 2028'' and adding
in its place the date ``April 14, 2028,''.
Sec. 162.1902 [Amended]
0
6. Amend Sec. 162.1902 by:
0
a. In paragraph (a), removing the date ``August 11, 2027--'' and adding
in its place the date ``August 14, 2027--'';
0
b. In paragraph (b) introductory text, removing the dates ``August 11,
2027 through February 11, 2028--'' and adding in its place the dates
``August 14, 2027 through April 14, 2028--''; and
0
c. In paragraph (c), removing the date ``February 11, 2028'' and adding
in its place the date ``April 14, 2028''.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-15958 Filed 8-20-25; 8:45 am]
BILLING CODE 4120-01-P
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