Billing and Coding: Hemophilia Factor Products

Internet-Only Manuals (IOMs):

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  • Chapter 17, Section 80.4 Billing for Hemophilia Clotting Factors, Section 80.4.1 Clotting Factor Furnishing Fee

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period

This Billing and Coding Article provides billing and coding guidance for Hemophilia Factor Products. 

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.

The Centers for Medicare & Medicaid Services (CMS) provided CR4229 to clarify billing practices for providers to ensure that units of service for blood clotting factor are reported accurately. Some Medicare providers have been billing units of drugs and biologicals incorrectly on outpatient bills as well as on inpatient claims for hemophilia clotting factors. The erroneous reporting of units of service has resulted in Medicare overpayments (reference Medicare Learning Network [MLN] Matters Number: 4229).

General Billing Instructions

The provider determines the dosage of hemophilia factor furnished to the beneficiary and using the definition of the appropriate HCPCS code, translates the dosage into units of service(s). See example below on translating the dosage administered into ‘units of service’.

Note: Not all short version descriptions of HCPCS codes define units for the HCPCS code. Providers are reminded to refer to the long descriptors of the HCPCS codes in their HCPCS book.

When submitting claims for hemophilia clotting factors it is essential to submit the correct Quantity Billed (QB) to receive the correct reimbursement. Some of the codes are based on international unit (IU) and some may be per milligram (mg) or microgram (mcg) as specified in the code descriptor. Therefore, the units of service(s) reported should reflect the number of IU, mg, or mcg being administered.

JW and JZ Modifiers

When billing for Part B drugs and biologicals (except those provided under a competitive acquisition program [CAP]), the use of the JW modifier to identify unused drugs or biologicals from single-dose containers or single-use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.

Any amount wasted must be clearly documented in the medical record and should include the date and time, amount of medication wasted, and the reason for the wastage.

The use of the JZ modifier (attesting that there were no discarded amounts) is required on claims to report there are no discarded amounts of unused drugs or biologicals from single-dose containers or single-use packages.

Claims for drugs separately payable under Medicare Part B from single-dose containers are required to report either the JW or JZ modifier, to identify any discarded amounts or to attest that there are no discarded amounts, respectively.

• The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.
• The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator “N1” (ASC).

Example of Translating the Dosage Administered into Units of Service 

The provider would calculate the ‘units of service’ with this equation: 13,365 mcg divided by 1 mcg equals 13,365. Note that the process for calculations based on one IU or one mg is the same as the process for calculations based on one mcg.

After the dosage administered has been translated into the total number of units of service, then the provider determines if multiple claim lines should be billed. See “Role of Medically Unlikely Edits (MUE) in Proper Billing”.

Role of Medically Unlikely Edits (MUE) in Proper Billing

When billing for units of service on the same date of service for the same HCPCS code, MUEs play a role in proper billing and coding. The number of units of service reported on the same date of service for the same HCPCS code cannot have a claim line quantity that exceeds the MUE value for that HCPCS code or that exceeds 9,999 units per claim line.

Refer to the CMS.gov website to verify the MUE for each HCPCS code being billed. The units to bill per claim line can be determined by dividing the total number of ‘units of service’ by the MUE value. However, if this amount is greater than 9,999 then an additional limitation will apply. See examples below.

Billing Instructions when MUE is Less than 9,999 Units Per Line

In the below example, the HCPCS code J7193 has a MUE Value of 4,000 units per line. This is the maximum number of units which can be billed per claim line (as per MUE Adjudication Indicator [MAI]). HCPCS code J7193 appears on the CMS.gov MUE spreadsheet as follows: 

If more than one line needs to be billed on the claim, the repeat service modifier (-76) must be appended to the second and subsequent lines.

Example:

Using the HCPCS code J7193 from above, the MUE Value is 4,000 units per line. If 12,500 IUs were administered to a beneficiary on the same date of service, then the total number of ‘units of service’ would be translated to 12,500 (based on the long descriptor, HCPCS code J7193 is per IU). The minimum number of claim lines to report this amount would be calculated as 4 lines (12,500 ÷ 4,000 = 3.125, requiring 4 lines as shown below). 

Do not report a date range as the date of service. Indicate date span in the narrative of the claim. If the claim is for a monthly supply of clotting factor distributed to the beneficiary on the date of service, indicate ‘monthly supply’ and the date span in the narrative of the claim or the EDI equivalent. For additional information on reporting DOS, see section below titled “Date of Service (DOS)”.

Billing Instructions when MUE is Greater than 9,999 Units Per Line

Due to system limitations, a maximum of 9,999 units of service may be billed on any one claim line. This limitation is applicable in addition to the established MUE limit for the HCPCS code. If the total number of ‘units of service’ exceeds 9,999 divide the total number of units of service by the maximum number of units that can be billed on a claim line to determine the minimum number of claim lines to bill.

Example:

The MUE for HCPCS code J7192 is 22,000 units per line, which exceeds the system limit of 9,999 units per line. If 22,000 IUs were administered to a beneficiary on the same date of service, then the total number of ‘units of service’ would be translated to 22,000 (based on the long descriptor, HCPCS code J7192 is per IU). The minimum number of claim lines to report this amount would be calculated as 3 lines (22,000 ÷ 9,999 = 2.20, requiring 3 lines as shown below). 

If reporting more than one line, bill all subsequent lines with modifier -76, repeat procedure. Do not report a date range as the date of service. Indicate date span in the narrative of the claim. If the claim is for a monthly supply of clotting factor distributed to the beneficiary on the date of service, indicate ‘monthly supply’ and the date span in the narrative of the claim or the EDI equivalent.

Billing for Not Otherwise Classified (NOC) Codes

When billing NOC codes, enter the drug name, dosage and NDC in the claim narrative or the EDI equivalent. Report the number of units in the quantity billed field as “1”.

Dollar Amount Exceeds $99,999.99

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

When billing two claims, ensure that the total dollar amounts are different on each claim.

Example:

The MUE for HCPCS code J7201 is 9,000 units per line. The beneficiary received 47,865 IUs of Factor IX (J7201) ($2.28 per unit). The billed amount is $109,132.20 for the same date of service. The claims should be billed as shown below.

Claim one:

Total Billed Amount is $99,998.52; total units would be 43,859.

Claim two:

Total Billed Amount is $9,133.68; total units would be 4,006. 

Note: Report a narrative description indicating "monthly billing" as well as the total number of units of service and total charge in item 19 of the 1500 claim form or the EDI equivalent.

Date of Service (DOS)

If the factor product is administered within a facility or "incident to" a physician service, the actual date the drug was administered should be reported as the DOS. If the factor product is being billed by a pharmacy to replenish the beneficiary's home supply, the date of delivery should be used as the DOS on the claim.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
4. Medical record documentation maintained in the patient’s file must document the condition for which the blood clotting factor is being given.
5. The name of the factor and the dosage required and/or given must be included in the records.

This information is normally found in the office/progress notes, pharmacy forms, hospital records, and/or treatment notes.