Billing and Coding: Hemophilia Factor Products

  
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  
  
**

**HCPCS Code** | **Short Descriptor** | **Billing Unit** | **Dosage
Administered** | **Units of Service**  
---|---|---|---|---  
J7189 | Factor viia | Per mcg (1mcg) | 13,365 mcg | 13,365  
  






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
](https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/MUE.html)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:  
  

**HCPCS** | **MUE Value** | **MUE Adjudication Indicator (MAI)** | **MUE
Rationale**  
---|---|---|---  
J7193 | 4,000 | 1 Line Edit | Clinical: Data  
  




  
  
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).  
  

**Line** | **Date of Service (From - To)** | **Procedure Code/Modifier** |
**Unit of Service** | **Billed Amount**  
---|---|---|---|---  
1 | 05 02 2022 - 05 02 2022 |       J7193 | 4,000 | $4,520.00  
2 | 05 02 2022 - 05 02 2022 |       J7193-76 | 4,000 | $4,520.00  
3 | 05 02 2022 - 05 02 2022 |       J7193-76 | 4,000 | $4,520.00  
4 | 05 02 2022 - 05 02 2022 |       J7193-76 | 500 | $565.00  
  










  
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).  
  

**Line** | **Date of Service (From - To)** | **Procedure Code/Modifier** |
**Unit of Service** | **Billed Amount**  
---|---|---|---|---  
1 | 05 11 2022 - 05 11 2022 |       J7192 | 9,999 | $13,489.65  
2 | 05 11 2022 - 05 11 2022 |       J7192-76 | 9,999 | $13,489.65  
3 | 05 11 2022 - 05 11 2022 |       J7192-76 | 2,002 | $2,702.70  
  








  
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.  
  

**Line** | **Date of Service (From - To)** | **Procedure Code/Modifier** |
**Unit of Service** | **Billed Amount**  
---|---|---|---|---  
1 | 06 01 2022 - 06 01 2022 |       J7201 | 9,000 | $20,520.00  
2 | 06 01 2022 - 06 01 2022 |       J7201-76 | 9,000 | $20,520.00  
3 | 06 01 2022 - 06 01 2022 |       J7201-76 | 9,000 | $20,520.00  
4 | 06 01 2022 - 06 01 2022 |       J7201-76 | 9,000 | $20,520.00  
5 | 06 01 2022 - 06 01 2022 |       J7201-76 | 7,859 | $17,918.52  
  










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

**Line** | **Date of Service (From - To)** | **Procedure Code/Modifier** |
**Unit of Service** | **Billed Amount**  
---|---|---|---|---  
1 | 06 01 2022 - 06 01 2022 | J7201-76 | 4,006 | $9,133.68  
  
  
 **  
**



**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.