Response to Public Comments

PRA 0938-0676: Response to Comment - 1k5-91fr-stnn
PRA Package 0938-0676, Reconciliation of State Invoice (ROSI) (CMS-304) and Prior Quarter
Adjustment Statement (PQAS) (CMS-304a) received two comments during the 60-day period.
One comment (1k5-91fr-stnn) is from a Collaborative Workgroup composed of individuals from
states, pharmaceutical manufacturers, and industry professionals, and one comment (1k5-91hychh8) is from a State (Nebraska).
Overview:
The Collaborative Workgroup is suggesting that CMS combine the Reconciliation of State
Invoice (ROSI) (CMS-304) and Prior Quarter Adjustment Statement (PQAS) (CMS-304a) into
one form, add additional fields to include payment details and a unique identifier field, and
mandate that it only be submitted electronically. The commenter further suggests that this
new/expanded combined ROSI/PQAS electronic format be implemented on or before July 2023.
CMS Response:
The purpose of this PRA package is to address specific updates needed to accommodate changes
made to the field lengths and file formats to accommodate the changes that will go into effect
when CMS transitions to the Medicaid Drug Programs (MDP) system in July 2021.While CMS
appreciates the suggestions made by the commenter, we are unable to commit to the suggested
July, 2023, timeframe. Furthermore, CMS is not prepared, at this time to determine if it would
mandate the use of the suggested new/expanded electronic ROSI/PQAS format.
Action(s) Taken:
CMS will take the commenter suggested edits to the Reconciliation of State Invoice (ROSI)
(CMS-304) and Prior Quarter Adjustment Statement (PQAS) (CMS-304a) under advisement,
however we are unable to confirm a specified timeframe in doing so, nor is it a guarantee that all
the suggested edits will be implemented. CMS would additionally like to note that a second
comment received from a state, mentions several reasons that their system is unable to
accept/accommodate electronic uploaded ROSI/PQAS. Therefore, prior to making any
enhancements to the functionality of the current ROSI or PQAS, CMS would reach out to all
stakeholders to solicit feedback on any potential issues/limitations that they might identify. All
responses/feedback would be taken into consideration prior to moving forward with making any
updates.
PRA 0938-0676: Response to Comment - 1k5-91hy-chh8
PRA Package 0938-0676, Reconciliation of State Invoice (ROSI) (CMS-304) and Prior Quarter
Adjustment Statement (PQAS) (CMS-304a) received two comments during the 60-day period.
One comment (1k5-91fr-stnn) is from a Collaborative Workgroup composed of individuals from
states, pharmaceutical manufacturers, and industry professionals, and one comment (1k5-91hychh8) is from a state (Nebraska).
Overview:
The state commenter mentions that their system is “home-grown” and is unable to accommodate
electronic submission of the Reconciliation of State Invoice (ROSI) (CMS-304) and Prior

Quarter Adjustment Statement (PQAS) (CMS-304a). They mention that it would be a long
process for all 51 states and the manufacturers (in which there are currently ~740 manufacturers
participating in the Medicaid Drug Rebate Program (MDRP)) to create/buy new systems.
Additionally, it could be a major cost to all. The commenter further mentions that they only
have two assigned MDRP accountants to handle all of the manufacturers. The commenter also
mentions that certain manufacturers only send the state invoice back as documentation, and
asked if these manufacturers would also need to adapt their system even though they are sending
back to the state exactly what was sent to them (the manufacturer). They additionally inquired if
there would be a way that these “electronic format ROSIs/PQAS” could be made to be printed so
that they could still be entered manually if a state is unable to upload them to their system.
CMS Response:
At this time, CMS is not mandating the use of the electronic Reconciliation of State Invoice
(ROSI) (CMS-304) or Prior Quarter Adjustment Statement (PQAS) (CMS-304a). States may
continue to utilize any manual processes currently in place. The purpose of this PRA package is
to address specific updates needed in order to accommodate changes being made to the field
lengths and file formats that will go into effect when CMS transitions to the Medicaid Drug
Programs (MDP) system in July 2021. States and manufacturers may still utilize the manual
process for sending invoices as well as ROSI and PQAS. CMS is unable to provide specific
responses to the commenter’s two inquires mentioned in the above overview, as we are not
mandating the use of the ROSI and PQAS at this time.
Action(s) Taken:
CMS will take the suggested edits to the Reconciliation of State Invoice (ROSI) (CMS-304) and
Prior Quarter Adjustment Statement (PQAS) (CMS-304a) under advisement. However, prior to
making any enhancements to the functionality of the current ROSI or PQAS, CMS would reach
out to all stakeholders to solicit feedback on any potential issues/limitations or additional burden
that might be identified. All responses/feedback would be taken into consideration prior to
moving forward with making any updates.