Ordering and Reimbursement

To order Cytogam^® Cytomegalovirus Immune Globulin Intravenous (Human) contact your specialty
distributor.

Cytogam is available at the following distributors:

• ASD
• BioCARE
• Cardinal SPD
• FFF Enterprises
• McKesson Plasma & Biologics
• McKesson Specialty
• Morris & Dickson
• Prodigy Health

For Product Information please contact Customer Service at 1-877-CMV-2449

Reimbursement Codes

The CPT^® and ICD-9-CM codes provided are based on American Medical Association (AMA) or Centers for Medicare
and Medicaid Services (CMS) guidelines and are provided for informational purposes only. The billing party is solely
responsible for appropriate coding of products or services (eg, CPT^® coding). As the information provided is not intended
to provide specific guidance on billing, and because government and other third-party payor coding requirements
change periodically, all coding requirements should be verified directly with the payor being billed.

Diagnostic Codes (ICD-10-CM)

ICD-10-CM Codes

Used to identify patient medical conditions (for claims with date of service on or after October 1, 2015).
Available at: icd10data.com, accessed August 2019.

Code	Description
B25.9	Cytomegaloviral disease, unspecified
T86.10	Unspecified complication of kidney transplant or
T86.11	Kidney transplant rejection or
T86.12	Kidney transplant failure
T86.20	Unspecified complication of heart transplant or
T86.21	Heart transplant rejection or
T86.22	Heart transplant failure
T86.30	Unspecified complication of heart-lung transplant or
T86.31	Heart-lung transplant rejection or
T86.32	Heart-lung transplant failure
T86.40	Unspecified complication of liver transplant or
T86.41	Liver transplant rejection or
T86.42	Liver transplant failure
T86.810	Lung transplant rejection or
T86.811	Lung transplant failure or
T86.819	Unspecified complication of lung transplant
T86.890	Other transplanted tissue rejection or
T86.891	Other transplanted tissue failure or
T86.899	Unspecified complication of other transplanted tissue

Billing Codes (HCPCS, CPT)

HCPCS Codes
The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and
maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or to electronic
claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier “HC” entered to Segment SV101-1 unless
otherwise directed by the payor.
Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html, accessed August 2019.

Code	Description
J0850	INJECTION, CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN), PER VIAL

CPT Codes
If the billing provider performs administration services in conjunction with a patient’s infusion, the following administration
codes may be used to bill for this service if the service meets the requirements of the code description.
Available at: https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx, accessed August 2019.

Code	Description
96365	Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
96366	Each additional hour

CPT^® is a registered trademark of the American Medical Association. All other brand, product, service, and feature
names of trademarks are the property of their respective owners.

To report SUSPECTED ADVERSE REACTIONS, contact Saol Therapeutics at 1-833-644-4216 or FDA at1-800-FDA-1088 or
www.fda.gov/medwatch.

Selected Important Safety Information for Cytogam^® (Cytomegalovirus Immune Globulin Intravenous [Human])

Cytogam is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

Cytogam is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deﬁciency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including Cytogam.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insuﬃciency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable. Agents containing sucrose as a stabilizer (Cytogam contains sucrose) have been associated with reports of renal dysfunction given at daily doses of 350 mg/kg or greater.

During administration, the patient’s vital signs should be monitored continuously, and careful observation made for any symptoms throughout the infusion. Epinephrine and diphenhydramine should be available for the treatment of an acute anaphylactic reaction.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Immune Globulin Intravenous (Human) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis.

Cytogam is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as ﬂushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam.

To report SUSPECTED ADVERSE REACTIONS, contact Kamada Therapeutics at +972-8-9406472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.