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pdfOMB Control Number: 0938-1394
Expiration Date: XX/XX/20XX
Qualified Health Plan Pharmacy Benefit
Manager (PBM) Drug Data, Pricing, and
Rebate Review (QHP PBM DPR2)
Template Instructions
Centers for Medicare & Medicaid Services
Center for Consumer Information and Insurance Oversight
08/02/2023
CCIIO/MPMG/OG
Department of Health & Human Services
Centers for Medicare & Medicaid Services
Center for Consumer Information and Insurance Oversight
200 Independence Avenue SW
Washington, DC 20201
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 0938-1394. The information collection included in this package reflects
the time and effort for submitters to provide prescription drug benefit information to CMS using the Health Information Oversight System (HIOS)
module. The time required to complete this information collection is estimated to average 122 hours per response, including the time to review
instructions, search existing data resources, gather the data needed, and to review and complete the information collection. This information collection,
pursuant to 45 CFR 156.295(a) and 184.50(a), requires PBMs to report prescription drug benefit information related to QHP issuers. All information
collected will be kept private in accordance with regulations at 45 C.F.R. 155.260, Privacy and Security of Personally Identifiable Information. 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,
Mail Stop C4-26-05, Baltimore, Maryland 21244-1850, Attention: Information Collections Clearance Officer.
Table of Contents
1.
Introduction ................................................................................................................................................1
2.
Data Requirements ....................................................................................................................................1
3.
2.1
Web Form ...........................................................................................................................................1
2.2
Detailed QHP PBM DPR2 Template ..................................................................................................8
2.3
Attestation Form ...............................................................................................................................10
Submission Instructions ...........................................................................................................................10
3.1
HIOS Account Creation and Template Retrieval ..............................................................................10
3.2
HIOS Pre-submission .......................................................................................................................11
3.3
Preparing Data for Submission .........................................................................................................11
Appendix .........................................................................................................................................................13
Allocation Methodology for Detailed Data Template File.............................................................................14
1. Introduction
The Patient Protection and Affordable Care Act (P.L. 111–148) and the Health Care and Education Reconciliation Act of
2010 (P.L. 111–-152) (collectively, the Patient Protection and Affordable Care Act [ACA]) were signed into law in 2010.
The ACA established competitive private health insurance markets, called Marketplaces or Exchanges, giving millions of
Americans and small businesses access to qualified health plans (QHPs), including stand-alone dental plans (SADPs).
Additionally, the ACA added section 1150A of the Social Security Act, requiring, among other entities, QHPs and
pharmacy benefit managers (PBMs) that serve QHPs to report information on prescription drug benefits to the U.S.
Department of Health and Human Services (HHS). CMS finalized regulations for this reporting at 45 CFR 156.295 and
184.50. This reporting is called the Qualified Health Plan Pharmacy Benefit Manager Drug, Data, Pricing, and Rebate
Review (QHP PBM DPR2).
Each year, PBMs that serve QHPs and QHP issuers that do not contract with a PBM—hereafter referred to as
“submitters”—will use a web form and template to submit required information related to prescription benefits via the
Health Insurance Oversight System (HIOS) PBM Module. Submitters will use an attestation form to confirm the accuracy,
completeness, and truthfulness of the submitted data, based on their best knowledge, information, and belief.
Submitters must provide the completed web form, template, and attestation form in the prescribed electronic format.
This document provides guidance and instructions for PBMs that contract with QHP issuers and for QHP issuers that
administer their own prescription drug plans on how to submit prescription drug, rebate, and spread pricing data as well as
an attestation form to comply with the QHP PBM DPR2 requirements.
2. Data Requirements
2.1 Web Form
Submitters will use the web form (Figure 2.1) and template (Figure 2.2) to submit required prescription information for
each issuer. Table 2.1 provides the input requirements for each field on the web form. All fields are required unless
designated with an asterisk (*) in Figure 2.1.
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Figure 2.1. QHP PBM DPR2 Web Form
2
3
Table 2.1. Summary QHP PBM DPR2 Reporting Requirements
Field Name
PBM Retained
Rebates
Field Descriptions and Exclusions
Field Character Limits
Enter all manufacturer rebates retained by the PBM and not
Numeric dollar amount. This
passed through to the QHP issuer. For issuer submitters that do field may have up to 12 digits
not contract with a PBM, enter all manufacturer rebates received. before the decimal and two
Exclusions: Do not include any rebates that are expected but not digits after the decimal.
yet received in this row; those must be reported in the “Rebates
Expected but Not Yet Received” field.
PBM Retained
Rebates (Additional
Comments)
This field is required when the “PBM Retained Rebates” field is
negative. Enter additional comments explaining why a negative
amount was reported.
This field is limited to 500
alphanumeric characters.
Rebates Expected
But Not Yet
Received
Include in this row good faith estimates of the sum of all rebate
amounts that are expected by the submitter for the applicable
year but have not yet been received from a drug manufacturer, if
applicable.
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal.
For PBM submitters, all rebate guarantee amounts expected, but
not yet received from manufacturers, 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 as of the compilation of this report have not yet
been passed to the QHP issuer, must be reported in this row.
Exclusions:
• Do not include any manufacturer rebates reported in the “PBM
Retained Rebates” row.
• Do not include any other types of remuneration.
PBM Incentive
Payments
Include in this row any incentive or bonus payments paid by the
QHP issuer to the PBM for performing administrative services for
its QHPs, such as negotiating rebates and drug prices as well as
increasing generic utilization. For QHP issuer submitters that do
not contract with a PBM, zero is acceptable.
4
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal.
Field Name
All Other Rebates
Field Descriptions and Exclusions
Field Character Limits
Include in this row the sum of the following rebate information.
Issuers that do not contract with a PBM are only required to enter
a value in this row as described under “For all Issuers.” Zero is
acceptable if not applicable.
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal. The
value reported in this field may
be negative.
For PBM submitters only:
Include all manufacturer rebates actually received from a
manufacturer by the PBM and passed through to the QHP. In
addition, 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.
For all submitters:
Include in this row estimated rebates at the 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.
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.
All Other Rebates
(Additional
Comments)
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
alphanumeric characters.
Price Concessions
for Administrative
Services From
Manufacturers
Include in this row all price concessions received by a submitter
from drug manufacturers for administrative services. Price
concessions that are reported here are received when the
manufacturer provides administrative services to the submitter at
a cost below market value.
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal.
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.
Exclusions: Do not include any rebate administration fees
collected by the QHP issuer or the PBM, which are reported as
“Bona Fide Service Fees”; these fees are not covered by the
QHP PBM DPR2 collection and should not be reported anywhere
in the web form or the detailed data template. 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.
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Field Name
All Other Price
Concessions From
Manufacturers
Field Descriptions and Exclusions
All price concessions received by a submitter from
pharmaceutical manufacturers for reasons not already captured
by the previous rows are reported here. Include any amounts
received and retained by submitters. If all price concessions
received from manufacturers are captured in the prior rows, the
value reported here will be zero.
Field Character Limits
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal.
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.”
All Other Price
Concessions From
Manufacturers
(Additional
Comments)
Additional comments are required when the field “All Other Price This field is limited to
Concessions From Manufacturers” is a non-zero value. Describe 500 alphanumeric characters.
the nature of all other price concessions reported in the “All Other
Price Concessions From Manufacturers” field.
Amounts Received
From Pharmacies
Reported in this row is any sum received by a submitter 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 if applicable (i.e., those not passed
through to the QHP issuer).
Specifically, if a submitter 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 submitter must be
reported in this row if it is not otherwise included in the negotiated
price, as it reduces the drug costs of the submitter.
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 submitter’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 submitter 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.
Exclusions: 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.
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Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal.
Field Name
Field Descriptions and Exclusions
Field Character Limits
Amounts Received
From Pharmacies
(Additional
Comments)
This field is required when the field “Amounts Received From
This field is limited to
Pharmacies” is a non-zero value. Describe the types of pharmacy 500 alphanumeric characters.
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.
Amounts Paid to
Pharmacies
Report any sum paid by a submitter to a pharmacy after the POS Numeric dollar amount. This
that is not otherwise required to be included in the negotiated
field may have up to 12 digits
price in this row.
before the decimal and two
digits after the decimal. The
Specifically, if a submitter pays a pharmacy a bonus payment
value reported in this field
after the POS, the amount paid by the submitter must be
must be negative or zero.
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 submitter.
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.
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.
Amounts Paid to
Pharmacies
(Additional
Comments)
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 alphanumeric characters.
PBM Spread
Amounts for Retail
Pharmacies
PBMs 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. For issuers that do not
contract with a PBM, zero is acceptable.
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal. For a
negative value, enter a minus
sign and the value for the field.
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.
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
that the pharmacy ultimately paid.
7
Field Name
PBM Spread
Amounts for Mail
Order Pharmacies
Field Descriptions and Exclusions
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. PBMs must report
aggregate values for all PBM spread amounts, not the PBM
spread for each mail-order pharmacy. For issuers that do not
contract with a PBM, zero is acceptable.
Field Character Limits
Numeric dollar amount. This
field may have up to 12 digits
before the decimal and two
digits after the decimal. For a
negative value, enter a minus
sign and the value for the field.
The value reported here must be for all covered drug costs.
If issuers use pass-through pricing to pay PBMs, this value must
be zero. PBMs must report in this row the difference between the
lock-in price and the price ultimately received by the pharmacy
for issuers that use lock-in pricing to pay PBMs.
2.2 Detailed QHP PBM DPR2 Template
Submitters must submit data at the HIOS Plan ID level for all fields included in Table 2.2. This includes counts of
prescriptions dispensed at the 11-digit NDC level using the National Drug Code Directory. Data must be formatted as a
pipe delimited comma-separated value (CSV or .csv) file and submitted in the Pharmacy Benefit Manager HIOS Module.
A blank copy of the detailed data template is available in the HIOS Knowledge Center (see Section 3 for additional
information on the HIOS Knowledge Center) within the PBM Module item.
Figure 2.2 Detailed QHP PBM DPR2 Template
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Table 2.2. Detailed PBM DPR2 Tab Reporting Requirements
Field name
Field descriptions and exclusions
Field character limits
Issuer_HIOS_Plan The QHP issuer’s 14-digit HIOS Plan ID. This number must
ID
be entered as exactly 14 digits and letters with no dashes
(e.g., 11111MD0002222).
14-character numeric characters
NDC
11-digit NDC (without dashes)
numeric characters
Submitters will enter the 11-digit NDC in this column. This
number must be entered as exactly 11 digits with no dashes
(e.g., 55555000102).
NDC codes must align with the current code definitions found
at the National Drug Code Directory. Ten-digit NDCs must be
converted to the 11-digit format.
Please include both generic and brand-name NDCs in the
detailed data file. Please exclude from submission any NDCs
representing compounded drugs.
Note that when converting from an .xls or .xlsx file type
to a .csv file type, leading zeros may be removed. To
ensure successful data submission, review the detailed data
template following file conversion to ensure that any NDC
codes beginning with one or more zero(s) have retained those
digits and appear exactly as 11-digit values.
Total_Prescription Submitters will provide the total number of prescriptions
s_Dispensed_All
dispensed for the associated NDC. This field should equal
the sum of the following two fields: “Total Prescription
Drugs Dispensed Retail Pharmacies” and “Total Prescription
Drugs Dispensed Mail Order Pharmacies.”
Numeric
Total_Prescription Submitters will provide the total number of prescription drugs
s_Dispensed_Ret dispensed through retail pharmacies.
ail_Pharmacies
Numeric
Total_Prescription Submitters will provide the total number of prescription drugs
s_Dispensed_Mail dispensed through mail-order pharmacies.
_Order_Pharmaci
es
Numeric
Total_Rebate_Doll Submitters will provide the total rebate amount received. This Numeric dollar amount
ars
field should be inclusive of all rebates entered on the
summary webform—including PBM-retained rebates, rebates
expected but not yet received, PBM incentive payments, and
all other rebates—at the NDC level.
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2.3 Attestation Form
Submitters will use either the QHP Issuer attestation form (Figure 2.3) or the PBM attestation form (Figure 2.4) to
confirm the accuracy, completeness, and truthfulness of the submitted data, based on their best knowledge, information,
and belief. Blank copies of each attestation form can be located in the HIOS Knowledge Center (see Section 3 for
additional information on the HIOS Knowledge Center) within the PBM Module item.
Figure 2.3. QHP PBM DPR2
Attestation Form (QHP Issuers Who
Do Not Contract With a PBM)
Figure 2.4. QHP PBM DPR2
Attestation Form (PBMs Reporting
on Behalf of an QHP Issuer)
3. Submission Instructions
Submitters must provide the completed web form, template, and attestation form in an electronic format. The following
section provides instructions for completing the data submission process and guidelines for complying with the data
collection requirements.
In addition to these instructions CMS expects that submitters will refer to the materials contained within the HIOS
Knowledge Center as they prepare their submission. Once on the HIOS homepage the PBM Module Knowledge Center
items can be accessed by navigating to “Knowledge Center” >> “Browse by Module” >> “Pharmacy Benefit Manager”.
Available resources in the Knowledge Center include the following:
•
•
•
•
The HIOS PBM User Manual: This manual provides further technical guidance and troubleshooting support for
submitters.
The PBM Attestation Form: This document allows submitters that are PBMs to attest to their submitted data.
The QHP Issuer Attestation Form: This document allows submitters that are QHP Issuers to attest to their
submitted data.
The QHP PBM DPR2 data template: This Microsoft Excel file is a blank version of the template that submitters
will provide to CMS. Note that this file will need to be converted from an .xlsx to a .csv format, and from “commadelimited” to “tab-delimited” format before submitting. For further guidance on converting to a “tab-delimited”
format, please see page 13 of this document.
3.1 HIOS Account Creation and Template Retrieval
Submitters must establish an account within the HIOS Pharmacy Benefit Manager Module and designate a single point of
contact to grant other users within their company access to perform prescription drug benefit management functions in
HIOS.
A PBM submitter must first be a registered user in HIOS to access the Pharmacy Benefit Manager Module. Instructions
for registering are available via the HIOS Production User Quick Reference Guide.
10
3.2 HIOS Pre-submission
Before the submission window opens CMS hosts a mandatory pre-submission period, during which submitters (i.e., PBMs
or QHP issuers) must inform CMS of the issuers for whom they intend to submit data. The purpose of the pre-submission
window is to confirm which submitting entity (QHP issuer or PBM) intends to submit for each Issuer ID that CMS
anticipates receiving data for. Submitters will complete pre-submission through the pre-submission window found on the
PBM Module home page in HIOS. There must be a single pre-submission issuer list per submitter (i.e., per Federal
Employer Identification Number) that all authorized individuals submitting for that company can access and manage.
Instructions for adding issuers to the pre-submission list are available via the HIOS Production User Quick Reference
Guide. Pre-submission must be completed before the submission period begins and requires the information found in
Table 3.1 to complete.
Table 3.1 Data Required to Complete Pre-submission Requirements
Field Name
Field Descriptions and Exclusions
Field Character Limits
Plan Year
Enter the plan year for which the submitter is submitting data.
Submissions in Calendar Year 2023 will be for Plan Year 2022.
Four-character numeric
Organization Name
Enter the name of the PBM. “N/A” is acceptable for issuer
submitters that do not contract with a PBM to administer
prescription drug benefits.
Alphanumeric
Organization FEIN
Enter the organization’s federal EIN/TIN.
Nine-character numeric
Issuer Name
Enter the name of the health insurance issuer offering qualified
health plans (QHP issuer) for which the submitter is submitting
data.
Alphanumeric
Issuer State
Enter the state where the QHP issuer’s plans are sold.
Two-character alphanumeric
Issuer HIOS ID
Enter the QHP issuer’s five-digit Health Insurance Oversight
System (HIOS) ID.
Five-character numeric
3.3 Preparing Data for Submission
Submitters will compile a set of QHP PBM DPR2 data per plan year and per issuer if the submitter is a contracted PBM. A
“set” of data includes the content shown in Table 3.2.
Table 3.2. QHP PBM DPR2 Data Set Contents
Content
Submission Method
Issuer-Level Aggregate
Data
HIOS web form
Detailed Data (data
submitted is at the Plan ID
[SCID] and National Drug
Code [NDC] levels)
Attachment submitted via HIOS. Must be a ZIP file containing one or
more pipe-delimited CSV files.
Attestation Form
Attachment submitted via HIOS. Must be a PDF.
If you are submitting data for an issuer that had zero pharmacy claims during the reporting year (e.g., an issuer offered
one or more on-Exchange QHP(s) in the reporting year but did not enroll any consumers during the reporting year) you
11
will still need to submit a detailed data template. In this case, after listing the 14-digit plan ID, you may complete the
template data fields as depicted in Figure 3.1.
Figure 3.1. Detailed QHP PBM DPR2 Template Completed for Zero Claims to Report
Allocation Methodology
Submitters are required to report financial and prescription data at the QHP issuer and 11-digit NDC levels. However,
CMS is aware that some submitters may receive and/or record data at the product or plan level. To satisfy the reporting
requirements, submitters must allocate data to the QHP issuer and 11-digit NDC levels 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 DPR2 reporting. Please see the Appendix for more
information on allocation methodologies.
Detailed Data Template File Submission Format
Once the submitter has fully populated the required data elements within the detailed data template, the template must be
converted to one or more pipe-delimited .csv file(s) which must then be grouped into one ZIP file for submission. There is
no required file-naming convention for the .csv file(s) or the final ZIP file. Instructions for converting from a commadelimited .csv file to a pipe-delimited .csv file are as follows.
1. Browse to your .csv comma-delimited file.
2. Right-click the file, click Open with, then click Notepad.
3. Press Ctrl + H on your keyboard to open the Replace window in Notepad. You can also open this window by
clicking Edit at the top of the window, then clicking Replace.
4. Type a “,” into the Find what field, type a “|” into the Replace with field, then click the Replace All button. The “|”
key on your keyboard is above the “Enter” key.
5. Close the Replace window, then save the edited file. Be sure to append the .csv file extension to the end of the
file name when saving it, as Notepad may try to save the file as a .txt file.
The following steps can then be used to create a ZIP folder containing multiple .csv files in Windows:
1. Place all .csv files within a single folder. This folder should only include files intended for submission.
2. Right-click on the folder, select “Send to,” then select “Compressed (zipped) folder.”
3. A new zipped folder with the same name is created in the same location.
3.4 Submitting Prepared QHP PBM DPR2 Data in HIOS
Submitters can create a submission in the HIOS PBM Module for a given issuer once they have prepared the detailed
data file and signed the attestation form for the issuer. To begin, submitters must enter the issuer-level aggregate data in
a web form. Submitters must then attach the corresponding detailed data template and attestation form to the submission.
Upon submission of the web form and detailed data file, the HIOS system will automatically perform several initial data
verifications. This process may take up to a few minutes and will result in either a “successful data verification” or a “failed
data verification” result. If the former, no further action is needed; if the latter, the detailed data file will need to be
corrected and reuploaded. The HIOS system will generate an email providing further guidance about how to rectify any
verification issues; this e-mail should arrive by the end of the day on which submission was initially completed. The
following table outlines potential causes of failed data verification, which will be further detailed via email.
12
Table 3.3. QHP PBM DPR2 Failed Data Verification Causes
Warning/Issue Description
Sample First Warning/Issue
Instance
Explanation of Issue Feedback
Column header did not match the
required column layout. See the
ICD for the file layout
specifications.
HIOS will indicate the file(s)
containing an incorrect column
header and will note the specific
column heading(s) in need of
adjustment.
Expected data rows were not
found in the data file or data file
was blank.
HIOS will indicate which (if any)
specific data rows are missing.
N/A
Issuer_HIOS_Plan_ID format is
invalid.
HIOS will indicate which
reported Issuer ID(s) will need
correction.
Issuer_HIOS_Plan_ID:
80316MN0010002-01
The NDC must be exactly 11-digits
with no hyphens.
HIOS will indicate which
reported NDC(s) will need
correction.
NDC: 10000-0000-3
The Issuer_HIOS_Plan_ID's Issuer
ID and State do not match
compared to the summary data for
the submission.
HIOS will indicate which
reported Issuer ID(s) do not
match submitted summary data.
Issuer_HIOS_Plan_ID:
12345VA0010002
Multiple rows with the same
Issuer_HIOS_Plan_ID and NDC
combination are not allowed.
HIOS will indicate which Issuer
ID and NDC combination(s) are
reported more than once.
Issuer_HIOS_Plan_ID:
80316MN0010002 NDC: 10000000004
The value for the prescription
dispensed fields (All, Retail, Mail
Order) must be non-negative
integers (whole numbers greater
than or equal to zero).
HIOS will indicate the plan ID(s)
for which invalid prescriptiondispensed data were reported
and will indicate the invalid
prescription value.
Issuer_HIOS_Plan_ID:
80316MN0010002 NDC: 10000000004
Total_Prescriptions_Dispensed_All: 30000004
The Total_Rebate_Dollars value
must be a numeric value with up to
12 places before the decimal point
and up to three places after the
decimal point.
HIOS will indicate the plan ID(s)
for which invalid rebate data
were reported and will indicate
the invalid rebate value.
Issuer_HIOS_Plan_ID:
80316MN0010002 NDC: 10000000007
Total_Rebate_Dollars:
123456789012.1486
The Product ID portion of the
Issuer_HIOS_Plan_ID (the first 10
characters) does not exist in HIOS.
HIOS will indicate the plan ID(s)
for which corresponding product
ID(s) were not found.
Issuer_HIOS_Plan_ID:
80316MN0010002
File Name: File_1.csv
Expected Column Header: NDC
Received Column Header: NDC11
If a failed data verification explanation email has not arrived within 24 hours of initial submission, please submit a help
desk ticket to [email protected] with the subject “QHP PBM DPR2 Failed Data Verification” and request that
your issue be routed to the HIOS Technical group for assistance. For further technical guidance related to submission
specifications and troubleshooting, please reference the HIOS PBM User Manual, available in the HIOS Knowledge
Center (see Section 3 for additional information on the HIOS Knowledge Center).
Appendix
This appendix contains additional information on the allocation methodology for completing the PBM DPR2 detailed data
template.
13
Allocation Methodology for Detailed Data Template File
CMS has identified several reasonable allocation methodologies (see below) and requires submitters to select the
applicable option from a drop-down menu when reporting the allocation methodology used. Submitters must make one
selection from a drop-down menu specifying an allocation methodology for reporting data at the issuer level and one
selection from a drop-down menu specifying an allocation methodology for reporting data at the 11-digit NDC level. If data
already were received from the manufacturers at the issuer and/or 11-digit NDC level, submitters should make the “No
allocation method needed” selection from the drop-down menu.
In the event a submitter uses different allocation methodologies for different types of data, they 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. Submitters
are strongly encouraged to use one of the allocation methodologies provided.
The options included in each drop-down menu are as follows:
Allocation Methodology to the QHP Issuer Level
1.
2.
3.
4.
5.
6.
7.
No allocation method needed at the QHP issuer level. Manufacturer data received at the QHP issuer level.
Allocation to the QHP issuer level based on Actual Drug Utilization.
Allocation to the QHP issuer level based on issuer’s Total Drug Spend.
Allocation to the QHP issuer level based on issuer’s Brand Drug Spend.
Allocation to the QHP issuer level based on Total Drug Spend for Drugs in Preferred Brand Tier.
Allocation to the QHP issuer level based on Billed Rebate Amounts.
Other allocation to the QHP issuer level (comments are required).
Allocation Methodology to the 11-digit NDC Level
1.
2.
3.
4.
5.
6.
7.
No allocation method needed at the 11-digit NDC level. Manufacturer data received at the 11-digit NDC level.
Allocation to the 11-digit NDC level based on Actual Drug Utilization.
Allocation to the 11-digit NDC level based on Plan’s Total Drug Spend.
Allocation to the 11-digit NDC level based on Plan’s Brand Drug Spend.
Allocation to the 11-digit NDC level based on Total Drug Spend for Drugs in Preferred Brand Tier.
Allocation to the 11-digit level based on Billed Rebate Amounts.
Other allocation to the 11-digit NDC level (comments are required).
Table A-1 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 the
determination of the reasonableness of the various allocation methodologies presented in Table A-1 is specific to the
allocation of manufacturer rebates, and 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.
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 11-digit 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.
14
Table A-1. Examples of Methodologies for Allocating Rebates to the QHP Issuer Level and 11-Digit NDC Levels
Allocation
Methodology
Considered Reasonable for
the Allocation of
Manufacturer Rebates?
Description
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 percentage
of the total number of units purchased by the PBM.
Yes
Appropriately
accounts for
differences in a
specific drug’s
utilization across
QHP issuers.
Based on Plan’s
Total Drug
Spend
Rebate amounts received for multiple drugs are
allocated to a QHP issuer based on the total drug
spend under the QHP issuer as a percentage 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
percentage of the total drug spending under the
QHP issuer.
Yes
Approximates
differences in
utilization and
spending on
rebate-eligible
drugs across QHP
issuers.
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
percentage 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 percentage
of the total drug spend for brand drugs under the
QHP issuer.
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.
Based on Total
Drug Spend for
Drugs in
Preferred Brand
Tier
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
percentage 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 NDC-specific total drug spend under the QHP
issuer as a percentage of the total drug spend for
drugs in the preferred brand tier under the QHP
issuer.
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.
Based on Billed
Rebate Amounts
Rebates received for a specific drug are allocated
to a QHP issuer and 11-digit NDC based on the
rebate amounts billed to the pharmaceutical
manufacturer for the specific QHP issuer and drug
as a percentage of the total rebate amount billed to
the pharmaceutical manufacturer for all of the
PBM’s QHP issuers.
Yes
Appropriately
accounts for
differences in a
specific drug’s
utilization across
QHP issuers.
15
Allocation
Methodology
Considered Reasonable for
the Allocation of
Manufacturer Rebates?
Description
Explanation
Based on
Enrollment
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
percentage of the total number of 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.
Based on
Advanced
Premium Tax
Credit (APTC)
Subsidy
Enrollment
Rebates received for multiple drugs are allocated to
a QHP issuer or 11-digit NDC based on the number
of low-income subsidy (LIS) beneficiaries enrolled
in the QHP issuer as a percentage 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.
Based on
Number of
Claims
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 percentage 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.
CMS will evaluate the appropriateness of an allocation methodology that has not already been identified as appropriate on
a case-by-case basis using the information that submitters provide on the methodology in the comment field.
16
File Type | application/pdf |
File Title | Qualified Health Plan Pharmacy Benefit Manager (PBM) Drug Data, Pricing, and Rebate Review (QHP PBM DPR2) Template Instructions |
Subject | CMS, qualified health plan, QHP, pharmacy benefit manager, PBM, drug data, pricing, rebate review, DPR2, template, U.S. Departme |
Author | Centers for Medicare & Medicaid Services |
File Modified | 2024-04-18 |
File Created | 2023-08-02 |