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INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be

disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the

full extent of the law. 1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard, Mailstop AR-21-55

Baltimore, Maryland 21244-1850

Investigations and Audits Group

Date: May 9, 2019

To: All Medicare Advantage Organizations (MAOs) and Prescription Drug Plan

Sponsors (PDPs)

From: Lori Bellan, Acting Director

Subject: Prosol

and Clinisol® The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Nat ional Benefit Integrity Medicare Drug Integrity Contractor (NBI MEDIC), has been made aware of potential billing error s associated with two amino acid preparations, Prosol (20% amino acid injection) and Clinisol (15% amino acid injection). The potential errors involve billing for the full quantity of the bulk package rather than the actual quantity dispensed and billing these products as non-compounds. The purpose of this notification is to alert plan sponsors to this information and to encourage plan sponsors to review billing patterns, and evaluate and cons ider taking measures to ensure the appropriate billing of these two products under the

Medicare Advantage

and Prescription Drug programs. The Medicare Part D Prescription Drug Event (PDE) data elements define the Quantity Dispensed as "how many dosage units of the medication were dispense d in the current drug event".1

Both Prosol

and Clinisol are provided in pharmacy bulk packages that may be used in the sterile preparation of multiple orders of parenteral nutrition. Accordingly, CMS generally would expect pharmacies preparing these admixtures to bill for the actual quantity dispensed for each admixture, and not for the full quanitity of the bulk package unless the full quanitity is dispensed . Inappropriate billing of the full bulk quanti ty rather than the actual quantity dispensed can lead to waste under the Medicare Program.

Prosol®

and Clinisol ® are both sterile amino acid preparations intended for use in compounding admixtures only and not for direct infusion. 2

Consequently, CMS expects these products to be

billed only as part of a compound provided to the patient. 1

Centers for Medicare & Medicaid Services, Medicare Part D Prescription Drug Event (PDE) Data Elements,

https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/downloads/pdedataelements.pdf Accessed March 11, 2019.

2 Prosol [package insert]. Deerfield, IL: Baxter Healthcare Corp; 2014 Clinisol [package insert]. Deerfield, IL: Baxter Healthcare Corp; 2018 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be

disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the

full extent of the law.

2 CMS and the NBI MEDIC conducted an analysis to identify billing patter ns for PDE records for

Prosol

and Clinisol from January 1, 2016, through September 30, 2018. Among the 630,766 PDE records and $128,526,643.57 in total paid amount for Prosol and Clinisol , 112,852 PDE records were billed both for the full bulk package quantity and as non-compounds, 142,742 PDE records were billed for the full bulk package quantity only, and 855 PDE records were billed as non compound s only. Please see the table below for a detailed breakdown.

Payment Category

PDE Record

Count

Total Paid

Amount

Bulk Package Quantity Only 142,742 $27,057,577.64

Non-Compound Only 855 $109,383.91

Both Bulk Package Quantity and

Non-Compound 112,852 $42,545,195.98

Total Potentially Inappropriate

PDE Records 256,449 $69,712,157.53

CMS welcomes feedback on any actions taken on the billing of Prosol or Clinisol by sending comments to

CPIMedicarePartD_Data@cms.hhs.gov

with "Prosol/Clinisol 2019" in the subject line.quotesdbs_dbs9.pdfusesText_15

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