Payment for Hemophilia Factors: Inpatient and Outpatient 5/17/21

Coverage
Inpatient

The Social Security Act (Section 1886(a)(4)) provides that hospitals receive extra payment for the costs of administering blood-clotting factor to Medicare hemophiliacs when they are hospital inpatients. Payment is based upon a price per unit of clotting factor multiplied by the units provided. Medicare provides coverage for these factor products through Part A (inpatient) and B coverage (‘incident to’) and self-administered products when the patients are competent to use the factors without medical supervision.

Medicare covers blood-clotting factors for the following conditions:

1. Factor VIII deficiency (classic hemophilia, hemophilia A).

2. Factor IX deficiency (hemophilia B, Christmas disease, plasma thromboplastin component).

3. Congenital factor XI deficiency (Hemophilia C).

4. Von Willebrand’s disease.

5. Acquired hemophilia (acquired Factor VIII autoantibodies most frequently) and other coagulation factor deficiencies, intrinsic circulating anticoagulants, antibodies or inhibitors.

6. Congenital deficiencies of other clotting factors (such as congenital afibrinogenemia and others).

It is important to note that under Part A (inpatient), these are the only diagnoses that are eligible for add-on-payment. The FDA label may list additional diagnoses for the products but they are not separately payable under Part A; payment will be included in the MS-DRG payment. 

Outpatient

For Part B (hospital outpatient, physician office), Medicare reimburses based upon HCPCS code and ASP pricing file and an annually updated ‘furnishing fee’. The ASP and Addendum B quarterly updates include the ‘furnishing fee’. MACs are instructed to add the furnishing fee to any blood clotting factors that are billed under a ‘not otherwise specified code’ requiring manual pricing by the MAC. In general under Part B, all FDA-labelled indications are covered, and those off-label uses that are supported by CMS-authorized compendia or significant published literature.

Charging

Most blood clotting factors are supplied as lot-specific products; each vial may have a different amount of active factor within a stated range. Providers are invoiced for the actual amount purchased, and therefore can only bill for that amount. For example, if a vial contains 484 units of Factor 8, it would not be appropriate to bill for 500 units even though it may be listed in a wholesaler catalog as a “rounded amount”. Billing in rounded increments often results in claims audits that result in payment refunds when the medical record substantiates a different amount was administered to the patient than the amount that was billed.

Billing

Both inpatient and outpatient claims require the blood clotting factor be listed by HCPCS code in revenue code 636 with the number of units administered to the patient. In general, inpatient claims remove the HCPCS detail and sum all charges per revenue code. When this occurs, the blood clotting factors may need to be added back to the inpatient claim so that appropriate payment can be calculated.

Novitas Solutions, Inc. has provided detailed instructions for billing Hemophilia Factor products including guidance on billing for products when the dose administered exceeds the Medically Unlikely Edit (MUE) established for that HCPCS code. Novitas instructs that a maximum of 9999 units should be listed for each line. If the billing exceeds 9999 units per date of service, or exceeds the MUE established for that HCPCS code, subsequent lines should reflect the remainder of the units with modifier -76 (repeat procedure). An example is provided in the Novitas Local Coverage Article #56433. 

Blood Clotting Factors which generate additional inpatient add-on payment are designated on the ASP Pricing File which is updated quarterly.  Column I, “Clotting Factor” contains a “1” for products which are eligible for reimbursement. A list of current designated clotting factors can be found in the Tools section of the website.

Self-Administered Blood Clotting Factors

First Coast provides billing guidance in Local Coverage Determination #33684 for self-administered blood clotting factors covered under Part A and Part B. Coverage of blood clotting factors for the following conditions is provided:

• Factor VIII deficiency (classic hemophilia, hemophilia A).

• Factor IX deficiency (hemophilia B, Christmas disease, plasma thromboplastin component).

• von Willebrand’s disease.

In addition, Anti-inhibitor coagulant complex (AICC) is a drug used to treat hemophilia in patients with Factor VIII inhibitor antibodies and is covered when furnished to patients with hemophilia A and inhibitor antibodies to Factor VIII who have major bleeding episodes and who fail to respond to other less expensive therapies. First Coast Local Coverage Article #A56482 provides detailed instructions and ICD-10-CM codes per HCPCS code.

Coding

As indicated above, for Part A, only certain diagnoses are eligible for separate payment and the corresponding ICD-10-CM diagnosis code must be listed on the claim. The Novitas LCA includes covered ICD-10-CM codes by HCPCS code. Diagnoses other than those listed in the LCA will in general not be covered. As with all claims, medical record documentation should support the diagnosis reported on the claim.

Shout-Outs!

1. Pharmacy should review drug profile set-ups to ensure that lot-specific blood clotting factors are set up to bill “per international unit” and reflect that the actual amount administered to the patient and not a “rounded amount”.

2. Pharmacy and Revenue Integrity should review each quarterly ASP Pricing File and MAC instructions to ensure that blood clotting factors eligible for inpatient add-on payments are reflected by HCPCS code on the final claim with the administered units by date of service and that appropriate ICD-10-CM codes are added to the claim based upon medical record documentation of the diagnosis/indication.

3. Pharmacy and Revenue Integrity should periodically review processes to ensure that the amount of blood clotting factor ordered by the physician matches the amount documented as administered by the caregiver, and that amount is correctly reflected as the billed units on the claim.