Medicare Part B covers administration of blood clotting factors and related items used for hemophilia patients able to use such factors without medical supervision. Hemophilia encompasses the following conditions:

• Factor VIII deficiency (classic hemophilia); hemophilia A-J7185, J7186, J7190, J7191, J7192);
• Factor IX deficiency (hemophilia B, plasma thromboplastin component (PTC) or Christmas factor deficiency (J7193, J7194, J7195, J7200-J7203); and
• Von Willebrand's disease (J7192)

Part B blood clotting factors are priced as a drug and biological under the drug pricing fee schedule. A furnishing fee will be paid for items and services associated with the clotting factor.

NOTE: The electronic claim examples below are for PC-ACE users. Providers not using PC-ACE should contact their software vendor for claim completion assistance.

Billing Instructions for MUEs Under 9,999 Units Per Line

CMS-1500 Claim Example

To calculate the correct units to bill per line, divide the number of units given by the Medically Unlikely Edit (MUE) Value. For example, HCPCS J7185 has a MUE Value of 4000 units line. This is the maximum number of units which can be billed per line (as per MAI). If more than one line needs to be billed, the repeat modifier (76) must be appended to the second and subsequent lines. Refer to the CMS Medicare Unlikely Edits for MUE Values.

• Patient received 12,000 IU of Factor VIII (J7185)
• Do not bill a date span on the claim. Indicate date span in narrative of the claim.
• Enter units given (not to exceed MUE per line) = up to 22,000
• Append modifier 76 to any second and subsequent lines

Electronic Claim Example

The NTE segment is located under the (1) Professional Claim form, (2) Billing Line Items Tab.  Currently, PC-ACE is limited to allow up to 9999 UOS per line.

Billing Instructions for MUEs Over 9,999 Units Per Line

Due to claims processing system limitations, if the total MUEs exceed 9,999 per claim line, divide claim lines up to the allowable MUEs per claim line (9,999). For example, J7182 has a per line MUE of 22,000. Due to the system limitations, each claim line is split up to the 9,999 MUE limitation. Do not span the dates on the claim line, but enter the date span in the narrative. Append modifier 76 to any second and subsequent lines.

CMS-1500 Claim Example

Electronic Claim Example

Billing Instructions for Not Otherwise Classified Codes

For Not Otherwise Classified HCPCS codes (NOC), enter the drug name, dosage and NDC in Loop 2400, SV101-7 segment (preferred) or Loop 2400, NTE02 for electronic claims. Loop 2400, segment SV104 (quantity billed) must be entered as "one" (1). Paper claim submitters must enter the number of units per line in Item 19 of the CMS-1500 claim form and the quantity billed as "one" (1).

CMS-1500 Claim Example

Electronic Claim Example

Dollar Amount Exceeds $99,999.99

If providing a month supply and the total billed amount exceeds $99,999.99, two claims must be submitted.

Additional Important Claim Information

• If required information is not submitted, claims will be denied as unprocessable. When codes are denied as unprocessable, provider must correct claim error and resubmit it
• If claim denies due to number of units exceeds acceptable maximum (for example N362), verify MUEs and number of allowable units. MUEs denied have appeal rights. Medical documentation must support services rendered

Date of Service

If the Factor VIII is administered within a facility or "incident to" a physician service, the actual date the drug was administered should be used as the DOS. If the Factor VIII is billed by a pharmacy, to replenish the patient's home supply, the date of delivery must be the DOS billed.

Documentation

The amount of clotting factors determined to be necessary to have on hand and thus covered under this provision will be based on the historical utilization pattern or profile developed by the carrier for each patient. Changes in a patient's medical needs over a period of time may require adjustments in the profile. It is expected that the treating source, e.g., a family physician or Comprehensive Hemophilia Diagnostic and Treatment Center, will have such information.
For hemophilia factors, we would expect:

• The diagnosis on a claim must be one of the hemophilia diagnosis codes
• Provider's prescription must include:
  • Name of drug
  • Concentration (if applicable)
  • Dosage to include initiation date, frequency of administration, duration of infusion (if applicable), signature, date and any other individual state requirements
• Record from the physician's office must include evidence of medical necessity
• Copy of this medical record must be provided on request

Resource

• CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 30
• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50-50.6
• CMS IOM Publication 100-03, National Coverage Determination (NCD) Manual, Chapter 1, Part 2, Section 110.3
• CMS IOM Publication, 100-04, Medicare Claims Processing Manual, Chapter 3, Section 20.7.3
• CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.4