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Reimbursement Alert On Line December Vol No New J by jmeltzer

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									                     Reimbursement Alert On-Line
                    (December 2006, Vol. 14, No. 2)

      New J-Code for Vivaglobin® Immune Globulin Subcutaneous

       Department of Health and Human Services, Centers for Medicare and Medicaid
Services, Announces New J-Code for Vivaglobin ® Immune Globulin Subcutaneous J-
1562

       On October 26, 2006, ZLB Behring, received notification from the Centers for
Medicare and Medicaid Services (CMS) granting our request to establish a new
Healthcare Common Procedure Coding System (HCPCS) code for Immune Globulin
Subcutaneous (Human) trade name: Vivaglobin®; J1562 “INJECTION IMMUNE
GLOBULIN, SUBCUTANEOUS, 100 MG.” The new code is effective January 1,
2007.
       It is for use by all payers, including Medicare, Medicaid and Private Insurers.

Billing for Vivaglobin:

        Since Vivaglobin® is a subcutaneous immune globulin product and is not
administered intravenously, it is not appropriate to bill for the product using J1566
(injection, immune globulin, intravenous, lyophilized (e.g. powder), 500 mg) or J1567
(injection, immune globulin, intravenous, non-lyophilized (e.g. liquid), 500 mg). J1562 is
the appropriate code when billing Subcutaneous Immune Globulin

Vivaglobin® is available in 3 convenient single use vials:

       •   3 ml vial = 480 mg Vivaglobin®
       •   10 ml vial = 1600 mg Vivaglobin®
       •   20 ml vial = 3200 mg Vivaglobin®

        The new code that CMS established for Vivaglobin® uses 100 mg as the unit
of measure for the code. As a result, if billing for 1600 mg, the claim should include 16
service units for J1562. For uneven multiples of 100 mg, health care providers billing
Medicare may bill consistently with the following provision at section 10 of Chapter 17
of the Medicare Claims Processing Manual (MCPM):

       “Drugs are billed in multiples of the dosage specified in the HCPCS/NDC. If the
       dosage given is not a multiple of the Health Insurance Common Procedure
       Coding System (HCPCS) code, the provider rounds to the next highest units in the
       HCPCS description for the code.”
       Under this policy, 5 service units would be billed for 480 mg of Vivaglobin®. In
addition, health care providers billing Medicare may bill consistently with CMS’ policy
on discarded drugs, which appears in section 40 of Chapter 17 of the MCPM:

        “The CMS encourages physicians to schedule patients in such a way that they can
        use drugs most efficiently. However, if a physician must discard the remainder of
        a vial or other package after administering it to a Medicare patient, the program
        covers the amount of drug discarded along with the amount administered.”

        Under this policy, if a patient were to receive a 1500 mg dose of Vivaglobin®
from a 1600 mg vial and the remaining 100 mg must be discarded, CMS policy would
permit the billing of 16 service units of Vivaglobin®.

        Health care providers should consult with other payers regarding their policies for
billing for uneven multiples of Vivaglobin® and billing for discarded drug.


    Vivaglobin® Reimbursement when Administered through an Infusion
     Pump qualify under Durable Medical Equipment (DME) provisions
        In June 2006, the Medicare Durable Medical Equipment Regional Carriers
(DMERCs) determined an infusion pump to be an integral part of Vivaglobin® therapy,
therefore, Vivaglobin® is covered under the DME provisions of Medicare Part B for
primary immune deficiency diagnoses.1 We have received many questions regarding the
reimbursement of Vivaglobin when using the infusion pump.

        Under the Medicare statute, section 1842(o)(1)(D) of the Social Security Act,
infusion drugs and biologicals furnished through an item of DME are not reimbursed by
Medicare through the Average Sales Price (ASP) reimbursement model. Instead, they are
paid at 95% of the average wholesale price (AWP) for the product in effect on October 1,
2003. CMS has said that for new DME infusion drugs, the payment rate would be set at
95% of the first available AWP. Only health care providers with DME supplier numbers
are to bill the DME MAC or DMERC. Coverage through DME MAC/DMERC includes
Vivaglobin® reimbursement as well as reimbursement for the pump, tubing and
ancillaries.




1
        As of July of 2006, CMS selected new contractors to process claims related to DME, replacing the
four DMERCs with four DME Medicare Administrative Contractors (DME MACs), although the
replacement of one of the DMERCs has been delayed because of a contract bid protest. The coverage of
Vivaglobin® remained the same after the switch to the DME MACs.
  Vivaglobin® SCIG Reimbursement through the Hospital Outpatient
               Prospective Payment System (HOPPS)
      Reimbursement for Vivaglobin through the Hospital Outpatient Perspective
Payment System will be set at ASP + 6%, updated quarterly.

        An ASP posting for Q1 2007 for J-Code 1562 for use in clinical, hospital
outpatient and physician office settings is expected to be included in the next set of ASP
rates that CMS likely will issue in the middle of December. [NOTE: This is the first
mention of the physician office setting. You may want to drop a footnote to address the
physician office setting since the two sections you have address the pharmacy supplier
and the hospital outpatient department.]

       All changes to the code set are effective January 1, 2007. The billable unit for
Vivaglobin®, Immune Globulin Subcutaneous under HCPCS Level II, J-1562 is equal to
100mg/one billable unit.

When converting patients from IVIG use the following dosing formula:

         •    Begin with IVIG Monthly Dose/Grams ÷Treatment interval = Weekly
              IVIG dose/gram
         •    E.g.: 40 grams monthly
         •    Monthly IVIg dose in grams ÷ 4 = weekly dose of Vivaglobin®
         •    Weekly dose ÷ .16 = mls per week. Mls per week x 1.37 = total weekly dose
              of Vivaglobin®.
         •    Total weekly dose x 4 = monthly Vivaglobin® dosing.

* treatment interval refers to how often patient receives IVIG (i.e.: if patient receives treatment every 3
weeks or every 4 weeks divide by that number.

When billing for Vivaglobin®, it is necessary to convert mls to mgs to obtain total
billable units.

         •    Billable unit = 100mg
         •    Total mls of Vivaglobin x 160 mg ÷ 100 mg = total number of billable units.
         •    E.g.: 40 grams ÷4 weeks = 10 grams/week
         •    10 grams ÷ .16 = 62.50 mls/week
         •    62.50 x 1.37 = 85.63ml
         •    Choose the most appropriate single use vial sizes for Vivaglobin (ie:4 of the
              20 mls and 2 of the 3 mls)
         •    86 x 160 = 13,760 mg
         •    13,760 ÷ 100 = 137.6 or 138 billable units/week
              or: 86 mls x 1.6 = 137.6 = 138 billable units

         •    Vivaglobin® monthly dosing (non IND study)
         •    E.g.: 40 grams/month
       •   Monthly IVIg dose in grams ¸ 4 = weekly dose of Vivaglobin®
       •   Weekly dose ¸ .16 = mls per week.
       •   Total weekly dose x 4= monthly Vivaglobin® dosing.
       •   Weekly dose x 160mg ¸100= total billable units/week

       •   Billable unit = 100 mg.
       •   Total mls of Vivaglobin® x 160mg ¸100mg = total number of billable units.
       •   E.g.: 40 grams ¸4 = 10 grams/week
       •   10 grams ¸ .16 = 62.5mls
       •   Choose the most appropriate single use vial sizes for Vivaglobin® (3 of the 20
           ml, + 1 of the 3 ml)
       •   63 mls x 160mg = 10080 mg
       •   10080 mg¸100 mg=100.8 or 101 billable units

       •   E.g.: 40 grams ¸4 = 10 grams/week
       •   10 grams¸ .16 = 62.5mls
       •   Choose the most appropriate single use vial sizes for Vivaglobin® (3 of the 20
           ml, + 1 of the 3 ml)
       •   63 mls x 160mg = 10080 mg
       •   10080 mg¸100 mg=100.8 or 101 billable units
       •   or: 63 mls x 1.6 = 100.8 = 101 billable units

Questions concerning appropriate coding for Medicare should be directed to the
Medicare third party payer or the Medicare Part B DME Contractor in whose
jurisdiction the claim would be filed. For private payers contact the insurance
contractor. For Medicaid systems, contact the Medicaid Agency in the state in which
the claim is being filed.

For reimbursement assistance regarding ZLB Behring therapies you may also contact
the ZLB Behring Reimbursement Answerline: 1-800-676-4266

References:
Department of Health and Human Services, Centers for Medicare and Medicaid
Services, 2007 HCPCS Annual Update, www.cms.hhs.gov/MedHCPCSGenInfo.
Region A, DMERC PSC Bulletin, June 2006

								
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