Oncology & Hematology Coding Alert

Adopt procedure code 30283B1; the hemophilia diagnosis does not support the use of Kcentra.

The Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra^® (Prothrombin Complex Concentrate [Human]). CMS invited public comments on the proposal to continue NTAP designation of Kcentra for fiscal year 2016 and received support for this decision. The continued NTAP designation for the third year in a row reinforces the benefits of the therapy in inpatient hospital settings.

What is NTAP policy? The CMS NTAP policy was implemented in 2001. The policy was intended to support timely access to innovative therapies for Medicare beneficiaries in the inpatient hospital setting. This applied to therapies that are not adequately paid for under the Medicare Severity Diagnosis-Related Groups (MS-DRGs).

To qualify for NTAP, the therapy or product needs to meet the following criteria:

• Must be a new therapy
• Must be inadequately paid for under existing MS-DRGs
• Must be proven to provide significant clinical improvement over existing therapies.

Is Kcentra a new therapy? To qualify for NTAP policy, Kcentra needs to meet the newness criteria. In this regard, CMS has considered the newness period to begin on April 29, 2013, when the FDA provided approval for this therapy. Thus, the 3-year anniversary date for the entry of Kcentra into the U.S. market happens to be on April 29, 2016 (FY 2016). Accordingly, CMS accepted to continue new technology add-on payments for this therapy for FY 2016.

Advancement: The conventional therapy used to restore depleted clotting proteins due to use of Warfarin is fresh frozen plasma (FFP). The administration of FFP needs matching for blood-type and thawing. Kcentra represents advancement in treatment as it can be administered more quickly and with less volume support than FFP, and needs no blood typing or thawing. Kcentra can be used in patients who are not eligible for FFP treatment, for example, patients deficient in IgA. Unlike FFP, Kcentra has no ABO antibodies, and carries a lesser risk of transfusion reactions.

Kcentra is likely to increase access to therapy for hospitals that do not have access to FFP due to lack of appropriate storage conditions. Kcentra is stable at room temperature for up to 36 months and needs no special storage conditions.

As of October 1, 2015, Turn to Code 30283B1

Since ICD–10-PCS is being implemented effective October 1, 2015, you should report the procedure code 30283B1 (Transfusion of nonautologous 4-factor prothrombin complex concentrate into vein, percutaneous approach) for administration of Kcentra for all dates of service on or after October 1, 2015.

Know Your Reimbursement: CMS will continue to reimburse hospitals an additional amount, up to $1,587.50 (MM8421, Revised on 11/25/13), for cases involving Kcentra that exceed the MS-DRG payment amount. This is calculated in accordance with an average dose of 2500 IU.

Vials of Kcentra contain 500 IU and are available at a cost of $635 per vial. The average dose of Kcentra is considered to be 2500 IU. Therefore, an average cost per case would be 5 times $635, i.e. $3,175.

Under section § 412.88(a)(2), CMS limits new technology add-on payments for a case to the lesser of:

• 50 percent of the average cost of the technology, or
• 50 percent of the costs in excess of the MS–DRG payment.

What does the extension mean for you? With the additional NTAP extension, hospitals will continue to have broad access to this biotherapy agent. This means that eligible Medicare beneficiaries who are treated in the inpatient setting with Kcentra will continue to receive payment through September 2016.

Beware of Hemophilia Diagnosis

You will not earn for Kcentra when the hospital received an add-on payment for a blood clotting factor administered to a patient who is a Medicare beneficiary diagnosed with hemophilia and treated as an inpatient.

This means that if you report ICD–10-CM diagnosis codes in the range of D66 (Hereditary factor VIII deficiency) - D68.4 (Acquired coagulation factor deficiency) in addition to ICD-10-PCS code 30283B1 for a patient who received Kcentra, you will not be reimbursed for new technology add-on payments.

For more information on the CMS NTAP approval for Kcentra, you may visit http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-19049.pdf.

For information on how the blood clotting factor add-on payment is made, you may refer to, the Medicare Claims Processing Manual (Pub 100-04), Chapter 3, Section 20.7.3. You may access this section at the CMS website. This is available at:  http://cms.gov/Regulationsand-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf.