REDLINE: 340B Repository Data Elements Reporting Instructions

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340B Repository Data Elements Reporting Instructions
In accordance with section 1860D-14B of the Social Security Act (“(the “Act”), for each 12month applicable period, starting with the applicable period beginning October 1, 2022, a
manufacturer of a Part D rebatable drug will owe a rebate, to be deposited into the Medicare
Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund, if the
annual manufacturer price exceeds the inflation-adjusted payment amount. As defined in section
1860D-14B(g)(1) of the Act, a “Part D rebatable drug” means, with respect to an applicable
period, a drug or biological described at section 1860D-14B(g)(1)(C)1 that is a covered Part D
drug as defined under section 1860D-2(e) of the Act. A drug approved under an abbreviated new
drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
is only subject to the Part D drug inflation rebate if it meets certain sole source criteria described
at sections 1860D-14B(g)(1)(C)(ii)(I)–(IV) of the Act. As described in section 1860D14B(g)(1)(B), the definition of a Part D rebatable drug does not include a drug or biological if, as
determined by the Secretary, the “average annual total cost” for such drug or biological under
Part D for a year per individual that uses such a drug or biological is less than the applicable
threshold.
Section 1860D-14B(b)(1)(B) of the Act requires that beginning with plan year 2026, the Centers
for Medicare & Medicaid Services (CMS) shall exclude from the total number of units for a Part
D rebatable drug, with respect to an applicable period, those units for which a manufacturer
provided a discount under the 340B Program. Because this requirement starts after the first
quarter of the applicable period that begins on October 1, 2025, the exclusion of 340B units will
only apply for the last three quarters of this applicable period. That is, CMS will exclude 340B
units starting on January 1, 2026.
As described in the Calendar Year (CY) 2026 Physician Fee Schedule (PFS) final rule, (90 FR
49748-49755), CMS adopted its proposal to establish a repositoryMedicare Part D Claims Data
340B Repository (hereinafter, “340B repository”) and allow 340B covered entities (hereinafter,
“covered entities”) to optionally submit to the 340B repository data elements from all of that
covered entity’sits Part D 340B claims with datesa date of service during the relevant period
which the covered entity determined utilized a drug for which the manufacturer provided a
discount under the 340B programProgram for covered Part D drugs billed to Medicare Part D
(hereinafter, “Part D 340B claims”). The 340B repository will allow In the CY 2027 PFS
proposed rule, CMS is proposing at § 428.203(c) to require all Medicare providers and suppliers
that are covered entities as defined at 42 CFR 10.3 (hereinafter collectively “340B providers”
unless otherwise noted) to submit this data directly to CMS (, beginning with claims with a date
of service on or aafter January 1, 2027, data elements associated with each claim for units of a
1

A drug or biological described in section 1860D-14B(g)(1)(C) is a drug or biological that, as of the first day of the
applicable period involved is: (1) a drug approved under a New Drug Application (NDA) under section 505(c) of the
FD&C Act; (2) a drug approved under an Abbreviated New Drug Application (ANDA) under section 505(j) of the
FD&C Act that meets certain criteria in section 1860D-14B(g)(1)(C)(ii) of the Act; or (3) a biological licensed under
section 351 of the Public Health Service (PHS) Act.

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covered Part D drug billed to Medicare Part D and dispensed by such covered entity or its
contractor), rather than through claims that dispensers submit to Part D plan sponsors.(s) (such as
contract pharmacies) for which a manufacturer provides a discount under the 340B Program to
such covered entity. Such reporting would fulfill a 340B provider’s obligation to provide access
to documentation relating to covered Part D drugs written or ordered by such 340B provider as a
condition of continued enrollment in Medicare, as we are proposing at § 424.516(f)(4) in
accordance with our authorities in sections 1842(h)(9) and 1866(a)(1)(X) of the Act. CMS
willwould consider all data elements received by the 340B repository to be associated with Part
D 340B claims; that is, CMS (or a contractor) would not further verify that submitted claims are
eligible for discounted pricing under the 340B Program or that 340B discounts were provided on
the units consistent with the 340B provider requirement to certify the accuracy of such
submissions. CMS intends to analyze the data submitted to the 340B repository to determine if
they could be used to fill such claims. Rather, thereliably in the future to remove 340B units from
Part D inflation rebate calculations in accordance with section 1860D-14B(b)(1)(B) of the Act.
We would match the stored data elements in the 340B repository to prescription drug event
(PDE) transactions for each Part D rebatable drug dispensed during the applicable period and
would evaluate 340B repository will serve solely to store these data. Under this process, CMS
will require a data for: (1) data integrity, and (2) submission frequency and completeness across
covered entity types and geographies. We also propose, as part of every submission, to require
340B providers (or an individual or contractor with the delegated authority as an authorized
representative of the 340B provider to perform the certification from covered entities that choose
to submit data to the 340B repository) to certify that the data elements from all claims submitted
to the 340B repository are from verified Part D 340B claims and, to the best of the covered
entity’s340B provider’s knowledge, their submission includesits submissions include all Part D
340B claims for the covered entity340B provider at the time of submission with dates of service
duringfor the relevant period. 340B providers or their authorized representative would be
required to certify the completeness and accuracy of the data submitted and to certify that the
submitter is authorized to submit on behalf of the 340B provider.
If CMS determines that the data reported to the 340B repository is usable and reliable and, in the
future, proposeproposes and adoptadopts a policy to use such data to exclude 340B units from
rebate calculations, then units associated with prescription drug event (PDE) transactions that
matchare matched to data elements stored in the 340B repository would be considered those for
which the manufacturer provided a discount under the 340B Program. During the testing period
beginning in 2026, CMS will assess the usability of the data submitted to the 340B repository to
remove 340B units from the total number of units used to calculate the total Part D inflation
rebate amount in the future.
General Instructions
Overview
The purpose of this collection of information request is for CMS to receive, via submission by
each covered entity that chooses to submit data to the 340B repository, by each 340B provider,

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certain data elements from all of that covered entity’s340B provider’s Part D 340B claims with
datesa date of service during the relevant an applicable period. CMS will assess the information
collection process and the suitability of the data collected to remove 340B units from the Part D
inflation rebate calculation in future program years. The 340B repository will allow covered
entities that choose to submit data to submit such data directly to CMS (or a contractor) using the
CMS-provided format. CMS established in the CY 2026 PFS final rule to require covered
entities that choose to submit data to the is proposing that 340B repository during the testing
period beginning in 2026providers would be required to submit fieldsdata elements specified by
CMS to the 340B repository by a date announced in the future, which would be no sooner than 3
months after the date on which the 340B repository is available to receive submissions from
covered entities. Covered entities that choose to submit data should submit data elementsat
proposed § 428.203(c) related to all Part D 340B claims with datesa date of service on or after
January 1, 2026. At a point in the future, CMS will provide a deadline that will allow sufficient
time for covered entities to gather, validate, and submit the specified data to the 340B repository.
CMS will provide the submission deadline(s) once the Medicare Prescription Drug Inflation
Rebate collection of information request is approved by the Office of Management and Budget.
During the rest of the testing period, CMS anticipates that covered entities will be expected
to2027.
CMS would require that each 340B provider report data on a quarterly basis (though they may
choose to submit more frequently) within 3 months of the end of a givenone calendar quarter.
For example, for following the close of the relevant calendar quarter. Each 340B provider would
submit 340B claims data with datesa date of service between October 1, 2026, through
December 31, 2026, covered entities that choose to submit data elements from Part D 340B
claims would submitduring the dataapplicable period directly to the 340B repository no later
than March 31, 2027using the CMS-specified format. The 340B units identified from these
quarterly submissions willwould be used to assessdetermine the suitabilityreliability of the
submitted data for future use to remove 340B units from the total number of units used to
calculate the total rebate amount specified in the Preliminary Rebate Report and Rebate Report
detailed at § 428.401(b) and (c), respectively. CMS also established
We expect that the 340B repository will be operational by Fall 2026 for voluntary submissions
from covered entities that choose , as we adopted in the CY 2026 PFS final rule. We strongly
encourage covered entities to submit begin submitting data to the 340B repository during the
testing period must provide information identifying the covered entity, specificallyvoluntarily in
2026 to test operational processes.
Beginning with claims with a date of service on or after January 1, 2027, as proposed in the
covered entity’s 340B ID and name as designated in the CY 2027 PFS proposed rule, all 340B
OPAIS database,2 when submitting claim information to the 340B repository. In addition to this
2

The 340B Office of Pharmacy Affairs Information System (340B OPAIS) database is accessed at
https://340bopais.hrsa.gov/home.

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identifying information, CMS established that covered entities that chooseproviders would be
required to submit data to theelements set forth in proposed § 428.203(c) from their Part D 340B
claims for all covered Part D drugs billed to Medicare Part D. Specifically, under the proposed §
428.203(c), 340B repository during the testing period beginning in 2026 must submitproviders
would be required to submit all of the following data elements from all Part D 340B claims
dispensed during the relevant time periodassociated with each claim for units of a covered Part D
drug billed to Medicare Part D and dispensed by the covered entity associated with such 340B
provider or its contractor(s) (such as contract pharmacies) for which a manufacturer provides a
discount under the 340B Program to such covered entity: (1) Date of Service (that is, the date the
prescription was filled by the pharmacy); (2) Prescription or Service Reference Number; (3) Fill
Number (that is, the code indicating whether the prescription is an original or a refill; if a refill,
the code indicates the refill number); (4) Dispensing Pharmacy NPI; and (5) NDC-11. CMS
willwould use these data elements to match claims to PDE transactions and perform further
analyses to assess the suitabilityreliability of the data for future use in removing 340B units from
Part D inflation rebate calculations. CMS may also use these data elements to conduct other
internal program analyses, such as those related to the Medicare Drug Price Negotiation
Program.
In addition, under proposed § 428.203(c), a 340B provider must submit its 340B ID and name as
designated in the 340B Office of Pharmacy Affairs Information System (OPAIS) database,3 when
submitting claim information.
Finally, under proposed § 428.203(c)(4), a 340B provider must resubmit data to the 340B
repository that is either incomplete or contains invalid data.
Submission Method
• In the CY 2026 PFS final rule, CMS established that covered entities may begin
submitting the fields specified by CMS 340B providers would be required to submit Part
D 340B claims data to the 340B repository beginning in 2026 for Part D 340B claims to
begin testing the usability of the 340B repository. This testing period will provide data for
CMS to conduct usability testing for the 340B repository and allow covered entities to
develop and test processes for submitting data elements to the 340B repository. CMS will
not use the data submitted during the testing period to remove units from the Part D
inflation rebate calculations. CMS will not use data submitted to the 340B repository to
remove units for the purpose of calculating Part D inflation rebates unless and until a
policy to do so is proposed and finalized. Many covered entities are providers and
suppliers regulated by CMS under Title XVIII of the Social Security Act, including
hospitals receiving Disproportionate Share Hospital (DSH) payments, Critical Access
Hospitals (CAHs) and Federally Qualified Health Centers (FQHCs). CMS will address
the possibility of mandatory reporting of Part D 340B claim data elements by covered
3

The 340B Office of Pharmacy Affairs Information System (340B OPAIS) database is accessed at
https://340bopais.hrsa.gov/home.

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entities to the 340B repository in future years in future rulemaking. CMS recommends
that covered entities take advantage of the testing period beginning in 2026 to prepare for
future policy development related to 340B repository reporting.
Covered entities that choose to submit data to the 340B repository during the testing
period will submit Part D 340B claims data to the 340B repository on a quarterly basis
using a format form and manner provided by CMS. CMS willwould receive and intake
the claims data provided from the covered entities340B providers as populated in the
format and manner specified by CMS. CMS willwould match submitted claims data from
covered entities340B providers to PDE transactions stored in the Drug Data Processing
System (DDPS).CMS claims data system. Units associated with PDE transactions that
matchare matched to data elements stored in the 340B repository would be considered
those for which the manufacturer provided a discount under the 340B Program and
therefore would be assessed for suitabilityreliability for future use in effectuating the
statutory directive at section 1860D-14B(b)(1)(B) of the Act to exclude 340B units from
the total number of units for a Part D rebatable drug, with respect to an applicable period,
those units for which a manufacturer provided a discount under the 340B Program.
In the CY 2026 PFS final rule, CMS established that covered entities that choose340B
providers would be required to submit the fields specifiedPart D 340B claims data to the
340B repository must do so within 3 months of the end of a givenone calendar quarter.
following the close of the relevant calendar quarter. For example, for claims with datesa
date of service between October 1, 20262027, through December 31, 2026, covered
entities 2027, 340B providers would be allowed to submit the data elements from Part D
340B claims to CMSthe 340B repository no later than March 31, 20272028.
For covered entities that choose to submit claims data to the 340B repository, CMS
willCMS would require the covered entities tothat 340B providers certify the accuracy
and completeness of the data submittedthey submit to the 340B repository, that the data
elements submitted to the 340B repository are from claims that have been verified as Part
D 340B claims, and, to the best of their knowledge, that the submission includesits data
submissions will include all Part D 340B claims for the covered entity340B provider with
a date of service during the relevant time period. 340B providers would attest to this
certification statement at the time of submission for the relevant period. of Part D 340B
claims. CMS willwould also require that the submitter iscertify that they are authorized to
submit on behalf of the covered entity. CMS intends to provide additional details related
to the precise process for submission of Part D 340B claims data during the voluntary
testing period as the 340B repository is developed. Interested parties provided feedback
to CMS requesting that any developed data submission method be created in a way that is
the least burdensome to covered entities.340B provider. CMS understands that covered
entities340B providers manage, store, and report their 340B claims data using different
systems and methods, and CMS intends to develop a submission method that allows
340B covered entitiesproviders to submit Part D 340B claims data using a standardized
format, based on file layout instructions provided by CMS, or via another submission
method not outlined here that is determined to provide a less burdensome method to

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covered entities that choose to submit Part D340B claims data during the testing
period.340B providers.
To ensure efficient matching between the Part D 340B claims data file and the PDE
transactions, CMS is considering applyingwill apply field -specific validation based on
PDE record standards to ensure that collected data elements align with the corresponding
data elements in the PDE transaction.
CMS will maintain data on transmitted Part D 340B claims data files to assist in records
management, downstream processing, and de-duplication of submissions, as needed.

Additional Instructions
• The instructions in this section apply to all data elements submitted by covered entities
from Part D 340B claims340B providers.
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Covered entities that choose to submit data to the 340B repositoryproviders are required
to submit data using the CMS-providedspecified format.

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Questions about the Medicare Prescription Drug Inflation Rebate programProgram
should be sent to [email protected]. Additional information
regarding the Medicare Prescription Drug Inflation Rebate Program can be found on
CMS’ website herehere.

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Each set of data elements is derived from a Part D 340B claim. A covered entity340B
provider may batch multiple sets of data elements, including from different 340B
pharmacies contracted with the associated covered entity, into a single file of data
elements to submit to the 340B repository.

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Example response formats are indicated within each data element description in the
example form.

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CMS understands that covered entities typically contract with vendors, such as 340B
third-party administrators (TPAs), to determine 340B eligibility of claims using data
provided by covered entities and their contract pharmacies. CMS willwould allow
covered entities that choose to submit data340B providers to arrange for their TPAs or
other vendors contracted vendors with their associated covered entity to submit certain
data elements to the 340B repository on their behalf. Covered entities340B providers are
ultimately responsible for the accuracy of the submission of data elements to the 340B
repository, even if a 340B provider’s associated covered entity has an arrangement with a
contracted entity to submit on its behalf. CMS may ask a TPA for additional information,
such as an up-to-date list of the 340B IDs for the covered entities associated with the
340B providers for which the TPA submits Part D 340B claims data.

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When reporting for a child site of the covered entity associated with the 340B provider, if
the child site’s 340B ID is not available in the OPAIS database, the 340B provider should
enter the parent site’s 340B ID in the 340B ID field of the 340B repository.

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In instances where the covered entity340B provider submits Part D 340B claims data to
the 340B repository, either directly or through a vendor, that is either (1) incomplete , (2)
is provided in an invalid format, and/or (23) contains invalid data, CMS may inform the
covered entity340B provider of such error and request that the covered entity340B
provider resolve and resubmit the Part D 340B claims data in order to process the
submission successfully.

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CMS willwould provide covered entities that choose to submit data to the 340B
repositoryproviders with additional time to submit data to reflect a revision to the 340B
determination of claims with datesa date of service throughout an applicable period. A
revision could come in one of two forms: (1)be either a resubmission of data for a claim
that the covered entity340B provider previously submitted to the 340B repository in error
or for a claim with errors in the requested data fields, or (2). Another example of a
revision could be a new submission of data for a claim for a drug that the covered
entity340B provider had previously determined was not purchased under the 340B
Program, but later identified was purchased under such program. after the end of the
reporting period. CMS willwould provide detailstechnical instruction on the process and
timing for covered entities340B providers to submit revised data to the 340B repository
after the end of the reporting period in the .

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CMS would provide further specifications in future technical instruction that would
include, but is not limited to, the specific formatting descriptions of data elements
submitted by 340B providers from Part D 340B claims to the 340B repository.

•

When a 340B provider submits a Part D 340B claim to the 340B repository, the 340B
provider would indicate through a Claim Record Indicator field if the submitted Part D
340B claim is a new Part D 340B claim to be added to the 340B repository or if it is a
previously submitted claim that should be removed. If a 340B provider determines that a
previously submitted claim is not 340B-eligible or otherwise needs to be changed, the
340B provider should use the Claim Record Indicator to flag the previously submitted
claim for removal from the 340B repository.

Definitions
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Date of Service: This data element is the date the prescription was filled by the pharmacy.
Prescription or Service Reference Number: This data element is the unique prescription
number that is assigned to the claim by the pharmacy.
Fill Number: This data element is the code indicating whether the prescription is an
original or a refill; if a refill, the code indicates the refill number.
Dispensing Pharmacy NPI: This data element is the NPI of the pharmacy that dispensed
the 340B Part D claim. The Dispensing Pharmacy NPI should be numeric only and not
include any dashes embedded within the number.

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NDC-11: This data element is the National Drug Code (NDC), provided in an eleven11digit format, for the dispensed product. The NDC-11 should not include dashes embedded
within the number.
Claim Record Indicator: The claim record indicator on the submission willwould indicate
the type of data submission relative to previous submissions. For example, “add” (A) for
a new submission, or “remove” (R) to indicate that previously submitted claim was sent
in error.
Covered Entity Name: The covered entity’s name of the covered entity associated with
the 340B provider as reported in the 340B OPAIS database. If thesuch covered entity
does not have a registered name as listed in the 340B OPAIS database, the covered
entity340B provider should provide theirthe legal business name when submitting
claims.of the associated covered entity.
Covered Entity 340B ID: The covered entity’s 340B ID of the covered entity associated
with the 340B provider as reported in the 340B OPAIS database. If the covered entity
does not have a 340B ID, then the covered entity shall leave this field blank.

Certification
The certification of the data elements submitted to the 340B repository shouldwill be executed
by (1) the chief executive officer (CEO) of the covered entity340B provider, (2) the chief
financial officer (CFO) of the covered entity340B provider, (3) an individual other than a CEO or
CFO, who has authority equivalent to a CEO or a CFO, or (4) an individual or contractor with
the delegated authority as an authorized representative of the covered entity340B provider to
perform the certification on behalf of one of the individuals mentioned in (1) through (3).

Certification Statement
I hereby certify, to the best of my knowledge, that the information included in the data elements
transmitted in this submission is complete and accurate and was prepared in good faith and after
reasonable efforts. I attest that the data elements submitted to the 340B repository are all from
claims that have been verified as Part D 340B claims and, to the best of my knowledge, the
submission includes all Part D 340B claims for the covered entity340B provider at the time of
submission for the relevant period. I understand that the information contained in this submission
is being provided to and will be relied upon by CMS for purposes of implementing the Medicare
Prescription Drug Inflation Rebate Program, in accordance with section 1860D-14B of the Social
Security Act. I agree to transmit revised data elements if I become aware that any information
submitted to the 340B repository has changed or is otherwise inaccurate. in this form has
changed or is otherwise inaccurate. I further certify that I am (1) the chief executive officer
(CEO) of the 340B provider, (2) the chief financial officer (CFO) of the 340B provider, (3) an
individual other than a CEO or CFO, who has authority equivalent to a CEO or a CFO, or (4) an
individual or contractor with the delegated authority as an authorized representative of the 340B
provider to perform the certification on behalf of one of the individuals mentioned in (1) through

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(3) and am authorized to submit the data elements in this submission on behalf of such 340B
provider.
Yes ☐