CMS-10725 - Appendix C PBM Transparency Submission Instructions

OMB Control Number: 0938-NEW
Expiration Date: XX/XX/2023

PBM Transparency in Coverage Reporting by
Qualified Health Plan Issuers
Appendix C – QHP issuer Data Collection
Introduction
Pharmacy Benefit Managers (PBMs) and issuers of Qualified Health Plans (QHPs) will use the
web form (Appendix A) and the template (Appendix B) to submit required information related to
prescription benefits via a HIOS module on an annual basis. PBMs will use the attestation
(Appendix D) to attest to the data’s accuracy, completeness, and truthfulness, based on their best
knowledge, information, and belief. PBMs must provide the completed template in an electronic
format. The following document provides instructions for completing the data submission
process and guidelines for complying with the data requirements.
HIOS Account Creation and Template Retrieval
Submitters must establish an account within the HIOS Pharmacy Benefits Managers Collection
Module and designate a single point of contact to grant other users within their company access
to perform PBM functions in HIOS. After creating an account and designating a point of
contact, the submitter may download a copy of the template from HIOS.
Template File Submission Format
Submitters must submit their completed templates as a tab delimited text (.txt) file for
submission in HIOS. Once the submitter has fully completed the required data elements on the
Excel template, it must be converted to the tab delimited text (.txt) file to be uploaded to HIOS
for submission. This can be done by first locating the “Save As” option in Excel. Submitters
must save the template with the convention “[Calendar Year] - [Issuer Name] - [HIOS ID] Template [X]. After naming the template, the submitter must select “Text (Tab delimited)” from
the drop-down menu under the “Save as Type” on the popup window and then select “Save.”
Figure 1 below indicates the process by which this can be done.

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Figure 1. How to convert Excel templates to .txt files for submission
Allocation methodology
PBMs or issuers that do not contract with a PBM are required to report PBM financial and
prescription data at the QHP issuer and 11-digit NDC level. We are aware, however, that some
submitters may receive and/or record data at the product or plan level instead. To satisfy the
reporting requirements, submitters must allocate data to the QHP issuer and 11-digit NDC level
using reasonable allocation methodologies. A description of all allocation methodologies used to
report data at the issuer and/or 11-digit NDC level must be submitted by the submitter in HIOS
as part of the PBM Transparency Reporting.
CMS has identified several reasonable allocation methodologies (see below) and requires that
submitters select the applicable option from a dropdown menu when reporting the allocation
methodology used. Submitters must make one selection from a dropdown menu specifying an
allocation methodology for reporting data at the issuer level and one selection from a dropdown
menu specifying an allocation methodology for reporting data at the 11-digit NDC level. If data
was already received from the manufacturers at the issuer and/or 11-digit NDC level, submitters
should make the “No allocation method needed” selection from the dropdown menu.
In the event that a submitter uses different allocation methodologies for different types of data,
the must select the “Other” option and describe in a comment the allocation methodologies used
and the data category for which each methodology was used. CMS may need to follow-up with
submitters to better understand allocation methodologies. Submitters should keep internal
documentation of all allocation methodologies used in anticipation of explaining them to CMS.

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The options included in each dropdown menu are the following:
Allocation Methodology to the QHP issuer level
1. No allocation method needed to the QHP issuer level. Data was received from the
manufacturer at the QHP issuer level.
2. Allocation to the QHP issuer level based on Actual Drug Utilization
3. Allocation to the QHP issuer level based on issuer’s Total Drug Spend
4. Allocation to the QHP issuer level based on issuer’s Brand Drug Spend
5. Allocation to the QHP issuer level based on Total Drug Spend for Drugs in Preferred Brand
Tier
6. Allocation to the QHP issuer level based on Billed Rebate Amounts
7. Other allocation to the QHP issuer level (comments are required)
Allocation Methodology to the 11-digit NDC level
1. No allocation method needed to the 11-digit NDC level. Data was received from the
manufacturer at the 11-digit NDC level.
2. Allocation to the 11-digit NDC level based on Actual Drug Utilization
3. Allocation to the 11-digit NDC level based on Plan’s Total Drug Spend
4. Allocation to the 11-digit NDC level based on Plan’s Brand Drug Spend
5. Allocation to the 11-digit NDC level based on Total Drug Spend for Drugs in Preferred Brand
Tier
6. Allocation to the 11-digit level based on Billed Rebate Amounts
7. Other allocation to the 11-digit NDC level (comments are required)
Table 2 provides examples of the allocation methodologies listed above and indicates whether
they are considered reasonable for allocating manufacturer rebate amounts to the QHP issuer and
11-digit NDC levels. Please note that our determination of the reasonableness of the various
allocation methodologies presented in Table 2 below is specific to the allocation of manufacturer
rebates, and that some of the methodologies determined to be unreasonable for rebate allocation
may in fact be reasonable for allocating other categories of data to a QHP issuer or 11-digit
NDC. For instance, allocation based on the number of claims, while unreasonable for use with
manufacturer rebates, could be appropriate for use with per-claim administrative fees charged to
pharmacies.

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Submitters, when able, should allocate rebates for a specific drug to the QHP issuer and 11-digit
NDC levels based on the actual utilization of that specific drug. Other allocation methodologies
may be subject to additional validation. When selecting among the options allowed, submitters
should consider the accuracy with which an allocation methodology applies rebate dollars to the
applicable QHP issuer or 11-digit NDC.
Submitters selecting “Other allocation to the QHP issuer level” or “Other allocation to the 11digit NDC level” must provide comments, which must identify the entity responsible for
applying the allocation methodology and include a clear explanation of the methodology, as well
as a specification of each category of data for which the methodology was used. The response
“Not Applicable,” or any of its variations, is not an acceptable explanation and will be rejected.
Table 1. Examples of Methodologies for Allocating Rebates to the QHP Issuer Level and
11-Digit NDC Levels
Allocation
Methodology

Description

Considered
Reasonable?

Explanation

Based on Actual
Drug Utilization

Rebate amounts received
for a specific drug are
allocated to a QHP issuer
and 11-digit NDC based
on the number of units of
the specific drug that
were purchased under the
QHP issuer as a percent
of the total number of
units purchased by the
PBM.
Rebate amounts received
for multiple drugs are
allocated to a QHP issuer
based on the total drug
spend under the QHP
issuer as a percent of the
total drug spend under all
of a PBM’s QHP issuers,
and further to an 11-digit
NDC based on the NDCspecific total drug spend
under the QHP issuer as a
percent of the total drug
spending under the QHP
issuer.

Yes

Appropriately accounts
for differences in a
specific drug’s utilization
across QHP issuers.

Yes

Approximates differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

Based on Plan’s
Total Drug Spend

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Allocation
Methodology

Description

Considered
Reasonable?

Explanation

Based on Plan’s Brand
Drug Spend

Rebate amounts received
for multiple
drugs are allocated to a
QHP issuer based on the
total drug spend for drugs
under the QHP issuer as a
percent of the total drug
spend for brand drugs
under all of the PBM’s
QHP issuers, and further
to an 11-digit NDC based
on the NDC-specific total
drug spend under the
QHP issuer as a percent
of the total drug spend for
brand drugs under the
QHP issuer.
Rebates received for
multiple drugs are
allocated to a QHP issuer
based on the total drug
spend for drugs in the
QHP issuer’s preferred
brand tier as a percent of
the total drug spend for
drugs in the preferred
brand tier of all of the
PBM’s QHP issuers, and
further to an 11-digit
NDC based on the NDCspecific total drug spend
under the QHP issuer as a
percent of the total drug
spend for drugs in the
preferred brand tier under
the QHP issuer.
Rebates received for a
specific drug are allocated
to a QHP issuer and 11digit NDC based on the
rebate amounts billed to
the pharmaceutical
manufacturer for the
specific QHP issuer and
drug as a percent of the
total rebate amount billed
to the pharmaceutical

Yes, but only if the
PBM receives
rebates only for
brand drugs.

Accounts for differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

Yes, but only if the
PBM receives
rebates only for
drugs in the
preferred brand
tier.

Accounts for differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

Yes

Appropriately accounts
for differences in a
specific drug’s utilization
across QHP issuers.

Based on Total Drug
Spend for Drugs in
Preferred Brand Tier

Based on Billed Rebate
Amounts

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Allocation
Methodology

Description

Considered
Reasonable?

Explanation

Rebates received for
multiple drugs are
allocated to a QHP issuer
or 11-digit NDC based on
the number of
beneficiaries enrolled in
the QHP issuer as a
percent of the total
number of beneficiaries
enrolled in all of the
PBM’s QHP issuers.
Rebates received for
multiple drugs are
allocated to a QHP issuer
or 11-digit NDC based on
the number of LIS
beneficiaries enrolled in
the QHP issuer as a
percent of the total
number of LIS
beneficiaries enrolled in
all of the PBM’s QHP
issuers.

No

Does not sufficiently
approximate differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

No

Does not sufficiently
approximate differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

Rebates received for
multiple drugs are
allocated to a QHP issuer
or 11-digit NDC based on
the number of claims
under the QHP issuer as a
percent of the total
number of claims
received under all of the
PBM’s QHP issuers.
Thus, allocation is based
on the total number of
claims for all of the drugs
rather than the number of
claims received for each
drug.

No

Does not sufficiently
approximate differences
in utilization and
spending on rebate
eligible drugs across
QHP issuers.

manufacturer for all of the
PBM’s QHP issuers.
Based on Enrollment

Based on Advanced
Premium Tax Credit
(APTC) Subsidy
Enrollment

Based on Number of
Claims

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CMS will evaluate the appropriateness of an allocation methodology we have not already
identified as appropriate, on a case-by-case basis, using the information submitters provide on
the methodology in the comment field.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless it displays a valid OMB control number. The valid OMB control number for this information
collection is 0938-NEW (Expires XX/XX/2023). The time required to complete this information collection is
estimated to average 203.64 hours per response, including the time to review instructions, search existing data
resources, and gather the data needed, and complete the template and review the information collection. If you
have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please
write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05,
Baltimore, Maryland 21244-1850. ****CMS Disclosure**** Please do not send applications, claims,
payments, medical records or any documents containing sensitive information to the PRA Reports
Clearance Office. Please note that any correspondence not pertaining to the information collection
burden approved under the associated OMB control number listed on this form will not be reviewed,
forwarded, or retained. If you have questions or concerns regarding where to submit your documents,
please contact Ken Buerger at [email protected], or LeAnn Brodhead at
[email protected].

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Appendix A, Summary PBM Transparency
Data Element Name

Data Element Description

Calendar Year

The calendar year for which the PBM is submitting data.

PBM Name

The name of the Pharmacy Benefit Manager (PBM).

Issuer Name
Issuer State

The name of the health insurance issuer offering Qualified Health Plans
(QHP issuer) for which the PBM is submitting data.
The state where the issuer’s plans are sold.

Issuer HIOS ID

The QHP issuer’s 5-digit Health Insurance Oversight System (HIOS) ID.

PBM Retained Rebates

Include all manufacturer rebates retained by the PBM and not passed
through to the QHP issuer.

PBM Retained Rebates
(additional comments)
Rebates Expected But Not
Yet Received

Exclusions:
Do not include any rebates expected but not yet received in this row,
which must be reported in the “Rebates Expected But Not Yet Received”
field. Do not include any rebate administration fees. Do not include any
other types of information, even if retained by the PBM.
Additional comments explaining why a negative amount was reported are
required when the “PBM Retained Rebates” field is negative.
This field is limited to 500 characters.
Include in this row good faith estimates of rebate amounts that are
expected by the PBM for the applicable year but have not yet been
received from a drug manufacturer, if applicable.
All rebate guarantee amounts expected but not yet received from PBMs
must also be reported in this row (see the “All Other Rebates” field for a
definition of PBM rebate guarantee amounts). Similarly, all rebate
amounts received by the PBM that are expected to be passed on to the
QHP issuer but have not yet, as of the compilation of this Report, been
passed to the QHP issuer must be reported in this row.
This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. This field must not be left blank.

PBM Incentive Payments

Exclusions: Do not include any manufacturer rebates reported in the
“PBM Retained Rebates” row. Do not include any other types of
remuneration.
Include in this row any incentive or bonus payments paid by the QHP
issuer to PBMs for performing administrative services for its QHPs, such
as negotiating rebates and drug prices as well as increasing generic
utilization.
This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. This field must not be left blank.

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Data Element Name
All Other Rebates

Data Element Description
Exclusions: Do not include any manufacturer rebates reported in the
“PBM Retained Rebates” or “Rebates Expected But Not Yet Received”
fields. Do not include rebate guarantee amounts that are expected but not
yet received; such amounts must be reported under the “Rebates Expected
But Not Yet Received” field. Do not include any other types of
remuneration from any other sources.
Include all manufacturer rebates actually received from a manufacturer by
the PBM and passed through to the QHP.
PBM Rebate Guarantee Amounts. Also include any rebate guarantee
amounts received from PBMs in connection with the QHP issuer. Rebate
guarantee amounts, generally, are payments received by QHP issuers from
PBMs to account for the difference between the rebate amount guaranteed
by a PBM, as likely delineated in the contract between the two parties, and
the actual rebate amount received from a drug manufacturer.
Estimated Rebates at Point-of-Sale (POS). The actual manufacturer rebate
amounts received for rebates that were estimated and applied to the
negotiated price at the POS are also reported in this row.

All Other Rebates
(Additional Comments)

Price Concessions for
Administrative Services
from Manufacturers

This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. The value reported in this field may be negative.
This field must not be blank.
Additional comments explaining why a negative amount was reported are
required when the “All Other Rebates” field is negative.
This field is limited to 500 characters.
Exclusions: Do not include any rebate administration fees collected by the
QHP issuer or the PBM. Do not include any pharmacy payments, fees, or
adjustments, which are to be reported in the fields “Amounts Received
From Pharmacies” and “Amounts Paid to Pharmacies” instead. Do not
include any other types of price concessions.
Include in this row all price concessions received by a PBM from drug
manufacturers for administrative services. Price concessions that are
reported here are received when the manufacturer provides administrative
services to the PBM at a cost below market value.
Also reported in this row are grants from pharmaceutical manufacturers
for services and programs such as utilization management and medical
education.
Applicable price concessions for administrative services that are not
associated with a specific drug must be reported in full in this row.
Additional Details: This field is numeric and may have up to 12 digits
before the decimal and 2 digits after the decimal. This field must not be
left blank.

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Data Element Name
All Other Price
Concessions from
Manufacturers

Data Element Description
Exclusions: Do not include any price concessions accounted for in the
following fields: “PBM Retained Rebates,” “Rebates Expected But Not
Yet Received,” “All Other Rebates.” Do not include price concessions
from pharmacies, which are reported in the following fields: “Amounts
Received from Pharmacies,” “Amounts Paid to Pharmacies.”
Additional Details: All price concessions received by a PBM from
pharmaceutical manufacturers for reasons not already captured by the
previous rows are reported here. Include any amounts received and
retained by PBMs. If all price concessions received from manufacturers
are captured in the prior rows, the value reported here will be zero.
This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. This field must not be left blank.

All Other Price
Concessions from
Manufacturers
(Additional Comments)

Additional comments are required when the field “All Other Price
Concessions from Manufacturers” is a non-zero value. Describe the nature
of all other price concessions reported in the “All Other Price Concessions
from Manufacturers” field.
This field is limited to 500 characters.

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Data Element Name
Amounts Received from
Pharmacies

Data Element Description
Exclude any pharmacy payment adjustments applied at the POS and all
post-POS incentive payments to pharmacies and positive adjustments to
pharmacy payments, which must be reported in the “Amounts Paid to
Pharmacy Field.” Do not include other types of remuneration.
Additional Details: Reported in this row is any sum received by a PBM
from a pharmacy after the POS that is not otherwise required to be
included in the negotiated price. Include any amounts received and
retained by PBMs (i.e., those not passed through to the QHP issuer).
Specifically, if a PBM pays a pharmacy a specified amount for a
prescription event but recoups some of the payment after the event, if, for
instance, the pharmacy has failed to meet performance standards set under
a performance-based payment arrangement, the amount recouped by the
PBM must be reported in this row if it is not otherwise included in the
negotiated price, as it reduces the drug costs of the PBM.
Examples of adjustments to be reported in this field include any
reconciliation amount that accounts for differences between the contracted
rate and the higher adjudicated rate received by the pharmacy at the POS
and contingent incentive fees related to, for instance, generic dispensing
rates, audit performance/error rates, refill rates, preferred dispensing rates,
and/or other performance metrics, including qualitative measures. Such
adjustments must only be reported in this row if they reduce the PBM’s
costs and are not otherwise included in the negotiated price.
This row must also include per-claim administrative fees collected, not
paid, by the PBM from pharmacies after the POS that are not included in
the negotiated price. Examples of such fees include, but are not limited to,
preferred pharmacy fees, fees related to extended supply rates, etc.

Amounts Received From
Pharmacies (Additional
Comments)

Amounts Paid to
Pharmacies

This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. This field must not be left blank.
This field is required when the field “Amounts Received From
Pharmacies” is a non-zero value. Describe the types of pharmacy price
concessions reported in the “Amounts Received From Pharmacies” field
and detail the metrics by which pharmacy performance was assessed, if
relevant to the price concession calculation.
This field is limited to 500 characters.
Exclusions: Do not include any payments to entities other than
pharmacies. Exclude any remuneration received from pharmacies (which
is reported in the “Amounts Received From Pharmacies” field). Do not
include other types of data.
Additional Details: Reported in this row is any sum paid by a PBM to a
pharmacy after the POS that is not otherwise required to be included in the
negotiated price.

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Data Element Name

Data Element Description
Specifically, if a PBM pays a pharmacy a bonus payment after the POS,
the amount paid by the PBM must be reported in this row as a negative
amount, if it is not otherwise included in the negotiated price, as it serves
to increase the drug costs of the PBM.
Examples of adjustments to be reported in this field include any
reconciliation amount that accounts for differences between the contracted
rate and the lower adjudicated rate achieved by the pharmacy at the POS
and contingent incentive payments related to, for instance, generic
dispensing rates, audit performance/error rates, refill rates, preferred
dispensing rates, and/or other performance metrics, including qualitative
measures. Such adjustments must only be reported in this row if they
increase the PBM’s costs and are not otherwise included in the negotiated
price.

Amounts Paid to
Pharmacies (Additional
Comments)

PBM Spread Amounts for
Retail Pharmacies

This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. The value reported in this field must be negative
or zero. This field must not be left blank.
Additional comments are required when the “Amounts Paid to
Pharmacies” field is a non-zero value. Describe the types of pharmacy
incentive payments reported in the “Amounts Paid to Pharmacies” field.
Please detail the metrics by which pharmacy performance was assessed, if
relevant to the incentive payment calculation.
This field is limited to 500 characters.
The aggregate amount of the difference between the amount paid by the
QHP issuer to the PBM and the amount the PBM pays retail pharmacies,
sometimes referred to as “PBM spread” or “risk premium,” must be
reported in this row.
We emphasize that PBM’s must report aggregate values for all PBM
spread amounts, not the PBM spread for each retail pharmacy. The value
reported here must be for all covered drugs.
If issuers use pass-through pricing to pay PBMs, this value must be zero.
Issuers that use lock-in pricing to pay PBMs must report in this row the
difference between the lock-in price and the price ultimately received by
the pharmacy.
PBM Spread Amounts for Retail Pharmacies are confidential and shall not
be disclosed by CMS, except in a form which does not disclose the
identity of a specific PBM, plan, or prices charged for drugs for the
purposes of carrying out Section 1150A of Social Security Act.
This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. For a negative value, enter a minus sign and the
value for the field. This field must not be left blank.

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Data Element Name

Data Element Description

PBM Spread Amounts for
Mail Order Pharmacies

The aggregate amount of the difference between the amount paid to the
PBM and the amount the PBM pays mail order pharmacies, sometimes
referred to as “PBM spread” or “risk premium,” must be reported in this
row. We emphasize that PBM’s must report aggregate values for all PBM
spread amounts, not the PBM spread for each mail order pharmacy.
The value reported here must be for all covered drug costs under EHB,
excluding spreads for drugs not covered under EHB.
If issuers use pass-through pricing to pay PBMs, this value must be zero.
Issuers that use lock-in pricing to pay PBMs must report in this row the
difference between the lock-in price and the price ultimately received by
the pharmacy.
PBM Spread Amounts for Mail Order Pharmacies are confidential and
shall not be disclosed by CMS, except in a form which does not disclose
the identity of a specific PBM, plan, or prices charged for drugs for
purposes of carrying out Section 1150A of Social Security Act.

Allocation Methodology
for Issuer Level Data

Allocation Methodology
for Issuer Level Data
Comments
Allocation Methodology
for 11-digit NDC Level
Data

Allocation Methodology
for 11-digit NDC Level
Data Comments

This field is numeric and may have up to 12 digits before the decimal and
2 digits after the decimal. For a negative value, enter a minus sign and the
value for the field. This field must not be left blank.
Dropdown menu with the following options:
1. No allocation method needed to the QHP issuer level. Data was
received from the manufacturer at the QHP issuer level.
2. Allocation to the QHP issuer level based on Actual Drug Utilization
3. Allocation to the QHP issuer level based on issuer’s Total Drug Spend
4. Allocation to the QHP issuer level based on issuer’s Brand Drug Spend
5. Allocation to the QHP issuer level based on Total Drug Spend for
Drugs in Preferred Brand Tier
6. Allocation to the QHP issuer level based on Billed Rebate Amounts
7. Other allocation to the QHP issuer level (comments are required)
Required field if “Other allocation to the QHP issuer level” is selected.
This field is limited to 500 characters.
Dropdown menu with the following options:
1. No allocation method needed to the 11-digit NDC level. Data was
received from the manufacturer at the 11-digit NDC level.
2. Allocation to the 11-digit NDC level based on Actual Drug Utilization
3. Allocation to the 11-digit NDC level based on Plan’s Total Drug Spend
4. Allocation to the 11-digit NDC level based on Plan’s Brand Drug
Spend
5. Allocation to the 11-digit NDC level based on Total Drug Spend for
Drugs in Preferred Brand Tier
6. Allocation to the 11-digit level based on Billed Rebate Amounts
7. Other allocation to the 11-digit NDC level (comments are required)
Required field if “Other allocation to the 11-digit NDC level” is selected.
This field is limited to 500 characters.

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Appendix B, Detailed PBM Transparency Template
Data Element Name
Issuer HIOS Plan ID
11-digit NDC

Total Number of
Prescriptions Dispensed
Total Number of
Prescription Drugs
Dispensed at Retail
Pharmacies
Total Number of
Prescription Drugs
Dispensed at Mail Order
Pharmacies
Total Rebate Amount

Data Element Description
The QHP issuer’s 14-digit HIOS Plan ID. This number must be entered as
exactly 14 digits and letters with no dashes (e.g., 11111MD0002222).
PBMs will enter the 11-digit National Drug Code (NDC) in this column.
This number must be entered as exactly 11 digits with no dashes (e.g.,
55555000102).
PBMs will provide the total number of prescriptions dispensed for the
associated of NDC.
PBMs will provide the total number of prescription drugs dispensed
through retail pharmacies.

PBMs will provide the total number of prescription drugs dispensed
through mail order pharmacies.

PBMs will provide the total rebate amount received.