CMS Pub. 100-04, ch. 17, § 70

NOTE: CMS seeks to reduce burden and modernize processes to ensure a reduction in improper

payments and an increase in customer satisfaction. The Certificate of Medical Necessity (CMN) form

and DME Information Form (DIF) were originally required to help document the medical necessity and

other coverage criteria for selected Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

(DMEPOS) items. In the past, a supplier received a signed CMN from the treating physician or created

and signed a DIF to submit with the claim. Due to improvements in claims processing and medical

records management, the information found on CMNs or DIFs is available either on the claim or in the

medical record and is redundant. Therefore, to reduce burden and increase customer satisfaction,

providers and suppliers no longer need to submit these forms for services rendered after January 1,

2023.

• For claims with dates of service on or after January 1, 2023 – providers and suppliers no

longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims

received with these forms attached will be rejected and returned to the provider or supplier.

• For claims with dates of service prior to January 1, 2023 – processes will not change and if

the CMN or DIF is required, it will still need to be submitted with the claim, or be on file with a

previous claim.

This statement applies throughout the Program Integrity Manual wherever CMNs and DIFs are

mentioned.

A/B MACs (B) are billed with the ASC X12 837 professional claim format or, if approved, with the

paper form CMS-1500. A/B MACs (A) are billed with the ASC X12 837 institutional claim format or,

if approved, with the paper Form CMS-1450.

See Chapters 24, 25 and 26 for detailed claims processing requirements, including forms, data

elements, and formats. See Chapters 21 and 22 for MSN and remittance record requirements. See the

official Washington Publishing Company web site for information about ASC X12 formats and related

training material.

In addition to requirements applicable to all claims the following apply to drug claims.

• On claims to A/B MACs (A) the drug is identified by the appropriate HCPCS code for the drug

administered and billed under revenue code 0636 unless specific instruction states otherwise;

• On claims to A/B MACs (B) the drug is identified by HCPCS code;

• All drugs, including Prodrugs, are reported to DME MACs by National Drug Code (see

§80.1.2);

• Where HCPCS is required, units are entered in multiples of the units shown in the HCPCS

narrative description. For example, if the description for the code is 50 mg, and 200 mg are

provided, units are shown as 4; See examples below.

• Where the NDC is required units are entered in multiples of the units shown in the NDC label

description. For example, if the description for the code is 50 mg., and 200 mg are provided,

units are shown as 4;

• If the units provided exceed the size of the units field, or require more characters to report than

spaces available in the format, repeat the HCPCS or NDC code on multiple lines until all units

can be reported;

• Covered administration codes for injections may be billed to the A/B MAC (B) and A/B MAC

(A) in addition to billing for the drug. The drug maximum payment allowance is for the drug

alone. However, if payment is under a PPS, such as OPPS, the injection would be included in

the APC rate.

The examples below include the HCPCS code and indicate the dosage amount specified in the

descriptor of that code. Facilities use the units field as a multiplier to arrive at the total dosage amount.

EXAMPLE 1

HCPCS J7189

Drug Factor VIIa

Dosage 1 mcg

Actual dosage: 13,365 mcg

On the bill, the facility shows J7189 and 13,365 in the units field (13,365 mcg divided by 1 mcg =

13,365 units).

NOTE: The process for dealing with one international unit (IU) is the same as the process of dealing

with one microgram.

EXAMPLE 2

HCPCS J9355

Drug Trastuzumab

Dosage 10 mg

Actual dosage: 140 mg

On the bill, the facility shows J9355 and 14 in the units field (140 mg divided by 10mg = 14 units).

When the dosage amount is greater than the amount indicated for the HCPCS code, the facility rounds

up to determine units. When the dosage amount is less than the amount indicated for the HCPCS code,

use 1 as the unit of measure.

EXAMPLE 3

HCPCS J3100

Drug Tenecteplase

Dosage 50 mg

Actual Dosage: 40 mg

The provider would bill for 1 unit, even though less than 1 full unit was furnished.

See §10 for a description of drug payment rules.