Arkansas Administrative Code
Agency 016 - DEPARTMENT OF HUMAN SERVICES
Division 06 - Medical Services
Rule 016.06.15-020 - Ambulatory Surgical Center 2-15, ARKids 3-15, Certifified Nurse Midwife 1-15. Early Periodic Screening Diagnosis and Treatment 2-15, Hospital 3-15, Federally Qualified Health Center 2-15, Home Health 3-15, Hyperalimentation 2-15, Physician 4-15, Prosethetics 5-15, Rural Health Clinic 2-15, Nurse Practioner 2-15, Transportation 1-15

A. Multiple units may be billed when applicable. Take-home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CRT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Covered Labelers

Arkansas Medicaid, by statute, will only pay for a drug procedure billed with an NDC when the phamriaceutical labeler of that drug is a covered labeler with Centers for Medicare and Medicaid Services (CMS). A "covered labeler" is a pharmaceutical manufacturer that has entered into a federal rebate agreement with CMS to provide each State a rebate for products reimbursed by Medicaid Programs. A covered labeler is identified by the first 5 digits of the NDC. To assure a product is payable for administration to a Medicaid beneficiary, compare the labeler code (the first 5 digits of the NDC) to the list of covered labelers which is maintained on the website at https://arkansas.maqellanrx.com/provider/documents/.

A complete listing of "Covered Labelers" is located on the website. See Diagram 1 for an example of this screen. The effective date is when a manufacturer entered into a rebate agreement with CMS. The Labeler termination date indicates that the manufacturer no longer participates in the federal rebate program and therefore the products cannot be reimbursed by Arkansas Medicaid on or after the termination date.

Diagram 1

In order for a claim with drug HCPCS/CPT codes to be eligible for payment, the detail date of service must be prior to the NDC termination date. The NDC termination date represents the shelf-life expiration date of the last batch produced, as supplied on the Centers for Medicare and Medicaid Services (CMS) quarterly update. The date is supplied to CMS by the drug manufacturer/distributor.

Arkansas Medicaid will deny claim details with drug HCPCS/CPT codes with a detail date of service equal to or greater than the NDC termination date.

When completing a Medicaid claim for administering a drug, indicate the HIPAA standard 11-digitNDCwith no dashes or spaces. The 11-digit NDC is comprised of three segments or codes: a 5-digit labeler code, a 4-digit product code and a 2-digit package code. The 10-digit NDC assigned by the FDA printed on the drug package must be changed to the 11-digit fonnat by inserting a leading zero in one of the three segments. Below are examples of the FDA-assigned NDC on a package changed to the appropriate 11-digit HIPAA standard fonnat. Diagram 2 displays the labeler code as five digits with leading zeros; the product code as four digits with leading zeros; the package code as two digits without leading zeros, using the " 5-4-2 " format.

Diagram 2

NDCs submitted in any configuration other than the 11-digit fonnat will be rejected/denied. NDCs billed to Medicaid for payment must use the 11-digit format without dashes or spaces between the numbers.

See Diagram 3 for sample NDCs as they might appear on drug packaging and the corresponding format which should be used for billing Arkansas Medicaid:

Diagram 3

B. Drug Procedure Code (HCPCS/CPT) to NDC Relationship and Billing Principles

HCPCS/CPT codes and any modifiers will continue to be billed per the policy for each procedure code. However, the NDC and NDC quantity of the administered drug is now also required for correct billing of drug HCPCS/CPT codes. To maintain the integrity of the drug rebate program, it is important that the specific NDC from the package used at the time of the procedure be recorded for billing. HCPCS/CPT codes submitted using invalid NDCs or NDCs that were unavailable on the date of service will be rejected/denied. We encourage you to enlist the cooperation of all staff members involved in drug administration to assure collection or notation of the NDC from the actual package used. It is not recommended that billing of NDCs be based on a reference list, as NDCs vary from one labeler to another, from one package size to another and from one time period to another.

Exception: There is no requirement for an NDC when billing for vaccines, radiopharmaceuticals, and allergen immunotherapy.

C. Claims Filing

The HCPCS/CPT codes billing units and the NDC quantity do not always have a one-to-one relationship.

Example 1: The HCPCS/CPT code may specify up to 75 mg of the drug, whereas the NDC quantity is typically billed in units, milliliters or grams. If the patient is provided 2 oral tablets, one at 25 mg and one at 50 mg, the HCPCS/CPT code unit would be 1 (1 total of 75 mg) in the example whereas the NDC quantity would be 1 each (1 unit of the 25 mg tablet and 1 unit of the 50 mg tablet). See Diagram 4.

Diagram 4

Click here to view image

Example 2: If the drug in the example is an injection of 5 ml (or cc) of a product that was 50 mg per 10 ml of a 10 ml single-use vial, the HCPCS/CPT code unit would be 1 (1 unit of 25 mg) whereas the NDC quantity would be 5 (5 ml). In this example, 5 ml or 25 mg would be documented as wasted. See Diagram 5.

Diagram 5

Click here to view image

D. Electronic Claims Filing 8371 (Outpatient)

Procedure codes that do not require paper billing may be billed electronically. Any procedure codes that have required modifiers in the past will continue to require modifiers.

Arl[LESS THAN]ansas Medicaid will require providers using Provider Electronic Solutions (PES) to use the required NDC format when billing HCPCS/CPT codes for administered drugs.

E. Paper Claims Filing CMS-1450 (UB-04)

Arkansas Medicaid will require providers billing drug HCPCS/CPT codes, including covered unlisted drug procedure codes, to use the required NDC format.

For institutional outpatient claims on the CMS-1450 (UB-04), use the locator field 43 (Description) to list the qualifier of "N4", the 11-digit NDC, the unit of measure qualifier (F2 - International Unit; GR - Gram; ML - Milliliter; UN - Unit), and number of units of the actual NDC administered, spaced and arranged exactly as in Diagram 6. Each NDC, when billed under the same procedure code on the same date of service, is defined as a "sequence."

When billing a single HCPCS/CPT code with multiple NDCs as detail sequences, the first sequence should reflect the total charges in the detail locator field 47 and total HCPCS/CPT code units in locator field 46. Each subsequent sequence number should show zeros in locator fields 46 and 47. See Detail 1, sequence 2 in Diagram 6. The quanfity of the NDC will be the total number of units billed for each specific NDC. See Diagram 6, first detail, sequences 1 and 2. Detail 2 is a Procedure Code that does not require an NDC. Detail 3, sequence 1 gives an example where only one NDC is associated with the HCPCS/CPT code.

Diagram 6

Click here to view image

F. Procedure Code/NDC Detail Attachment Form-DMS-664

For drug HCPCS/CPT codes requiring paper billing (i.e., for manual review), complete every field of the DMS-664 "Procedure Code/NDC Detail Attachment Form." Attach this form and any other required documents to your claim when submitting it for processing. See Diagram 7 for an example of the completed form. View or print form DMS-664 and instructions for completion.

Diagram 7

Click here to view image

G. Adjustments

Paper adjustments for paid claims filed with NDC numbers will not be accepted. Any original claim will have to be voided and a replacement claim will need to be filed. Providers have the option of adjusting a paper or electronic claim electronically.

H. Remittance Advices

Only the first sequence in a detail will be displayed on the remittance advice reflecting either the total amount paid or the denial EOB(s) for the detail.

I. Record Retention

Each provider must retain all records for five (5) years from the date of service or until all audit quesfions, disputes or review issues, appeal hearings, investigations or administrafive/judicial litigation to which the records may relate are concluded, whichever period is longer.

At times, a manufacturer may question the invoiced amount, which results in a drug rebate dispute. If this occurs, you may be contacted requesting a copy of your office records to include documentation pertaining to the billed HCPCS/CPT code. Requested records may include NDC invoices showing the purchase of drugs and documentation showing what drug (name, strength and amount) was administered and on what date, to the beneficiary in question.

A. Multiple units may be billed when applicable. Take-home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CPT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Covered Labelers

Arkansas Medicaid, by statute, will only pay for a drug procedure billed with an NDC when the pharmaceutical labeler of that drug is a covered labeler with Centers for Medicare and Medicaid Services (CMS). A "covered labeler" is a pharmaceutical manufacturer that has entered into a federal rebate agreement with CMS to provide each State a rebate for products reimbursed by Medicaid Programs. A covered labeler is identified by the first 5 digits of the NDC. To assure a product is payable for administration to a Medicaid beneficiary, compare the labeler code (the first 5 digits of the NDC) to the list of covered labelers which is maintained on the website at https://arkansas.maqellanrx.com/provider/documents.

A complete listing of "Covered Labelers" is located on the website. See Diagram 1 for an example of this screen. The effective date is when a manufacturer entered into a rebate agreement with CMS. The Labeler tennination date indicates that the manufacturer no longer participates in the federal rebate program and therefore the products cannot be reimbursed by Arkansas Medicaid on or after the termination date.

Diagram 1

In order for a claim with drug HCPCS/CPT codes to be eligible for payment, the detail date of service must be prior to the NDC termination date. The NDC termination date represents the shelf-life expiration date of the last batch produced, as supplied on the Centers for Medicare and Medicaid Services (CMS) quarterly update. The date is supplied to CMS by the drug manufacturer/distributor.

Arkansas Medicaid will deny claim details with drug HCPCS/CPT codes with a detail date of service equal to or greater than the NDC termination date.

When completing a Medicaid claim for administenng a drug, indicate the HIPAA standard 11-digit NDC with no dashes or spaces. The 11-digit NDC is comprised of three segments or codes: a 5-digit labeler code, a 4-digit product code and a 2-digit package code. The 10-digit NDC assigned by the FDA printed on the drug package must be changed to the 11-digit format by inserting a leading zero in one of the three segments. Below are examples of the FDA assigned NDC on a package changed to the appropriate 11-digit HIPAA standard format. Diagram 2 displays the labeler code as five digits with leading zeros; the product code as four digits with leading zeros; the package code as two digits without leading zeros, using the " 5-4-2 " format.

Diagram 2

NDCs submitted in any configuration other than the 11-digit format will be rejected/denied. NDCs billed to Medicaid for payment must use the 11-digit fonnat without dashes or spaces between the numbers.

See Diagram 3 for sample NDCs as they might appear on drug packaging and the corresponding format which should be used for billing Arkansas Medicaid:

Diagram 3

B. Drug Procedure Code (HCPCS/CPT) to NDC Relationship and Billing Principles

HCPCS/CPT codes and any modifiers will continue to be billed per the policy for each procedure code. However, the NDC and NDC quantity of the administered drug is now also required for correct billing of drug HCPCS/CPT codes. To maintain the integrity of the drug rebate program, it is important that the specific NDC from the package used at the time of the procedure be recorded for billing. HCPCS/CPT codes submitted using invalid NDCs or NDCs that were unavailable on the date of service will be rejected/denied. We encourage you to enlist the cooperation of all staff members involved in drug administration to assure collection or notation of the NDC from the actual package used. It is not recommended that billing of NDCs be based on a reference list, as NDCs vary from one labeler to another, from one package size to another and from one time period to another.

Exception: There is no requirement for an NDC when billing for vaccines, radiopharmaceuticals and allergen immunotherapy.

A. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Multiple units may be billed when applicable. Take-home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CPT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Covered Labelers

Arkansas Medicaid, by statute, will only pay for a drug procedure billed with an NDC when the pharmaceutical labeler of that drug is a covered latjeler with Centers for Medicare and Medicaid Services (CMS). A "covered labeler" is a pharmaceutical manufacturer that has entered into a federal rebate agreement with CMS to provide each State a rebate for products reimbursed by Medicaid Programs. A covered labeler is identified by the first 5 digits of the NDC. To assure a product is payable for administration to a Medicaid beneficiary, compare the labeler code (the first 5 digits of the NDC) to the list of covered labelers which is maintained on the website at https://arkansas.maqeflanrx.com/provider/documents/.

A complete listing of "Covered Labelers" is located on the website. See Diagram 1 for an example of this screen. The effective date is when a manufacturer entered into a rebate agreement with CMS. The Labeler termination date indicates that the manufacturer no longer participates in the federal rebate program and therefore the products cannot be reimbursed by Arkansas Medicaid on or after the termination date.

Diagram 1

In order for a claim with dnjg HCPCS/CPT codes to be eligible for payment, the detail date of service must be prior to the NDC termination date. The NDC termination date represents the shelf-life expiration date of the last batch produced, as supplied on the Centers for Medicare and Medicaid Services (CMS) quarterly update. The date is supplied to CMS by the drug manufacturer/distributor.

Arkansas Medicaid will deny claim details with drug HCPCS/CPT codes with a detail date of service equal to or greater than the NDC termination date.

When completing a Medicaid claim for administering a drug, indicate tlie HIPAA standard 11-digit NDC with no dashes or spaces. The 11-digit NDC is comprised of three segments or codes: a 5-digit labeler code, a 4-digit product code and a 2-digit package code. The 10-digit NDC assigned by the FDA printed on the drug package must be changed to the 11-digit format by inserting a leading zero in one of the three segments. Below are examples of the FDA assigned NDC on a package changed to the appropriate 11-digit HIPAA standard fomiat. Diagram 2 displays the labeler code as five digits with leading zeros; the product code as four digits with leading zeros; the package code as two digits without leading zeros, using the " 5-4-2 " format.

Diagram 2

NDCs submitted in any configuration other than the 11-digit format will be rejected/denied. NDCs billed to Medicaid for payment must use the 11-digit format without dashes or spaces between the numbers.

See Diagram 3 for sample NDCs as they might appear on drug packaging and the corresponding format which should be used for billing Arkansas Medicaid:

Diagram 3

B. Drug Procedure Code (HCPCS/CPT) to NDC Relationship and Billing Principles

HCPCS/CPT codes and any modifiers will continue to be billed per the policy for each procedure code. However, the NDC and NDC quantity of the administered drug is now also required for correct billing of drug HCPCS/CPT codes. To maintain the integrity of the drug rebate program, it is important that the specific NDC from the package used at the time of the procedure be recorded for billing. HCPCS/CPT codes submitted using invalid NDCs or NDCs that were unavailable on the date of service will be rejected/denied. We encourage you to enlist the cooperation of all staff members involved in drug administration to assure collection or notation of the NDC from the actual package used. It is not recommended that billing of NDCs be based on a reference list, as NDCs vary from one labeler to another, from one package size to another and from one time period to another.

Exception: There is no requirement for an NDC when billing for vaccines, radiopharmaceuticals and allergen immunotherapy.

Procedure Code/NDC Detail Attachment Form - DMS-664

For drug HCPCS/CPT codes requiring paper billing (i.e., for manual review), complete every field of the DMS-664 "Procedure Code/NDC Detail Attachment Form." Attach this form and any other required documents to your claim when submitting it for processing. See Diagram 7 for an example of the completed form. Section V of the provider manual includes this form.

Diagram 7

Click here to view image

A. Multiple units may be billed when applicable. Take-home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CRT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Covered Labelers

Arkansas Medicaid, by statute, will only pay for a drug procedure billed with an NDC when the pharmaceutical labeler of that drug is a covered labeler with Centers for Medicare and Medicaid Services (CMS). A "covered labeler" is a pharmaceutical manufacturer that has entered into a federal rebate agreement with CMS to provide each State a rebate for products reimbursed by Medicaid Programs. A covered labeler is identified by the first 5 digits of the NDC. To assure a product is payable for administration to a Medicaid beneficiary, compare the labeler code (the first 5 digits of the NDC) to the list of covered labelers which is maintained on the website at https://arkansas.maqellanrx.com/provider/documents/.

A complete listing of "Covered Labelers" is located on the website. The effective date is when a manufacturer entered into a rebate agreement with CMS. The Labeler termination date indicates that the manufacturer no longer participates in the federal rebate program and therefore the products cannot be reimbursed by Arkansas Medicaid on or after the termination date. In order for a claim with drug HCPCS/CPT codes to be eligible for payment, the detail date of service must be prior to the NDC termination date. The NDC termination date represents the shelf-life expiration date of the last batch produced, as supplied on the Centers for Medicare and Medicaid Services (CMS) quarterly update. The date is supplied to CMS by the drug manufacturer/distributor.

Arkansas Medicaid will deny claim details with drug HCPCS/CPT codes with a detail date of service equal to or greater than the NDC termination date.

When completing a Medicaid claim for administering a drug, indicate the HIPAA standard 11 -digit NDC with no dashes or spaces. The 11 -digit NDC is comprised of three segments or codes: a 5-digit labeler code, a 4-digit product code and a 2-digit package code. The 10-digit NDC assigned by the FDA printed on the drug package must be changed to the 11-digit fonnat by inserting a leading zero in one of the three segments. Below are examples of the FDA-assigned NDC on a package changed to the appropriate 11-digit HIPAA standard format. Diagram 1 displays the labeler code as five digits with leading zeros; the product code as four digits with leading zeros; the package code as two digits without leading zeros, using the " 5-4-2 " format.

Diagram 1

NDCs submitted in any configuration otiier than tiie 11-digit format will be rejected/denied. NDCs billed to Medicaid for payment must use the 11-digit fonnat without dashes or spaces between the numbers.

See Diagram 2 for sample NDCs as they might appear on drug pacl[LESS THAN]aging and the corresponding format which should be used for billing Arkansas Medicaid:

Diagram 2

B. Drug Procedure Code (HCPCS/CPT) to NDC Relationship and Billing Principles

HCPCS/CPT codes and any modifiers will continue to be billed per the policy for each procedure code. However, the NDC and NDC quantity of the administered drug is now also required for correct billing of drug HCPCS/CPT codes. To maintain the integrity of the drug rebate program, it is important that the specific NDC from the package used at the time of the procedure be recorded for billing. HCPCS/CPT codes submitted using invalid NDCs or NDCs that were unavailable on the date of service will be rejected/denied. It is not recommended that billing of NDCs be based on a reference list, as NDCs vary from one labeler to another, from one package size to another and from one time period to another.

Exception: There is no requirement for an NDC when billing for vaccines, radiopharmaceuticals and allergen immunotherapy.

C. Claims Filing

The HCPCS/CPT codes billing units and the NDC quantity do not always have a one-to-one relationship.

Example 1: The HCPCS/CPT code may specify up to 75 mg of the drug, whereas the NDC quantity is typically billed in units, milliliters or grams. If the patient is provided 2 oral tablets, one at 25 mg and one at 50 mg, the HCPCS/CPT code unit would be 1 (1 total of 75 mg) in the example, whereas the NDC quantity would be 1 each (1 unit of the 25 mg tablet and 1 unit of the 50 mg tablet). See Diagram 3.

Diagram 3

D. Electronic Claims Filing 8371 (Outpatient)

Procedure codes that do not require paper billing may be billed electronically. Any procedure codes that have required modifiers in the past will continue to require modifiers.

Arl[LESS THAN]ansas Medicaid will require providers using Provider Electronic Solutions (PES) to use the required NDC forniat when billing HCPCS/CPT codes for administered drugs.

E. Paper Claims Filing CMS-1450 (UB-04)

Arkansas Medicaid will require providers billing drug HCPCS/CPT codes, including covered unlisted drug procedure codes, to use the required NDC fonnat.

For institutional outpatient claims on the CMS-1450 (UB-04), use the locator field 43 (Description) to list the qualifier of "N4," the 11-digit NDC, the unit of measure qualifier (F2 - International Unit; GR - Gram; ML - Milliliter; UN - Unit) and number of units of the actual NDC administered, spaced and arranged exactly as in Diagram 5. Each NDC when billed under the same procedure code on the same date of service is defined as a "sequence." When billing a single HCPCS/CPT code with multiple NDCs as detail sequences, the first sequence should reflect the total charges in detail locator field 47 and total HCPCS/CPT code units in locator field 46. Each subsequent sequence number should show zeros in locator fields 46 and 47. See Detail 1, sequence 2 in Diagram 5. The quantity of the NDC will be the total number of units billed for each specific NDC. See Diagram 5, first detail, sequences 1 and 2. Detail 2 is a Procedure Code that does not require an NDC. Detail 3, sequence 1 gives an example where only one NDC is associated with the HCPCS/CPT code.

Diagram 5

F. Procedure Code/NDC Detail Attachment Form-DMS-664

G. Adjustments

Paper adjustments for paid claims filed with NDC numbers will not be accepted. Any original claim will have to be voided and a replacement claim will need to be filed. Providers have the option of adjusting a paper or electronic claim electronically.

H. Remittance Advices

Only the first sequence in a detail will be displayed on the remittance advice reflecting either the total amount paid or the denial EOB(s) for the detail.

I. Record Retention

Each provider must retain all records for five (5) years from the date of service or until all audit questions, disputes or review issues, appeal hearings, investigations or administrative/judicial litigation to which the records may relate are concluded, whichever period is longer. At times, a manufacturer may question the invoiced amount, which results in a drug rebate dispute. If this occurs, you may be contacted requesting a copy of your office records to include documentation pertaining to the billed HCPCS/CPT code. Requested records may include NDC invoices showing the purchase of drugs and documentation showing what drug (name, strength and amount) was administered and on what date, to the beneficiary in question.

A. Multiple units may be billed when applicable. Take-home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CPT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

A. Covered Labelers

Arkansas Medicaid, by statute, will only pay for a drug procedure billed with an NDC when the phamiaceutical labeler of that drug is a covered labeler with Centers for Medicare and Medicaid Services (CMS). A "covered labeler" is a pharmaceutical manufacturer that has entered into a federal rebate agreement with CMS to provide each State a rebate for products reimbursed by Medicaid Programs. A covered labeler is identified by the first 5 digits of the NDC. To assure a product is payable for administration to a Medicaid beneficiary, compare the labeler code (the first 5 digits of the NDC) to the list of covered labelers which is maintained on the website at https://arkansas.maqellanrx.com/provider/documents/.

A complete listing of "Covered Labelers" is located on the website. The effective date is when a manufacturer entered into a rebate agreement with CMS. The Labeler termination date indicates that the manufacturer no longer participates in the federal rebate program and therefore the products cannot be reimbursed by Arkansas Medicaid on or after the termination date. In order for a claim with drug HCPCS/CPT codes to be eligible for payment, the detail date of service must be prior to the NDC termination date. The NDC termination date represents the shelf-life expiration date of the last batch produced, as supplied on the Centers for Medicare and Medicaid Services (CMS) quarterly update. The date is supplied to CMS by the drug manufacturer/distributor.

Arkansas Medicaid will deny claim details with drug HCPCS/CPT codes with a detail date of service equal to or greater than the NDC termination date.

When completing a Medicaid claim for administering a drug, indicate the HIPAA standard 11-digit NDC with no dashes or spaces. The 11-digit NDC is comprised of three segments or codes: a 5-digit labeler code, a 4-digit product code and a 2-digit package code. The 10-digit NDC assigned by the FDA printed on the drug package must be changed to the 11-digit format by inserting a leading zero in one of the three segments. Below are examples of the FDA-assigned NDC on a package changed to the appropriate 11-digit HIPAA standard format. Diagram 1 displays the labeler code as five digits with leading zeros; the product code as four digits with leading zeros; the package code as two digits without leading zeros, using the " 5-4-2 " fonnat.

Diagram 1

NDCs submitted in any configuration other than the 11-digit format will be rejected/denied. NDCs billed to Medicaid for payment must use the 11-digit fonnat without dashes or spaces between the numbers.

See Diagram 2 for sample NDCs as they might appear on drug packaging and the corresponding format which should be used for billing Arkansas Medicaid:

Diagram 2

B. Drug Procedure Code (HCPCS/CPT) to NDC Relationship and Billing Principles

HCPCS/CPT codes and any modifiers will continue to be billed per the policy for each procedure code. However, the NDC and NDC quantity of the administered drug is now also required for correct billing of drug HCPCS/CPT codes. To maintain the integrity of the drug rebate program, it is important that the specific NDC from the package used at the time of the procedure be recorded for billing. HCPCS/CPT codes submitted using Invalid NDCs or NDCs that were unavailable on the date of service will be rejected/denied. It is not recommended that billing of NDCs be based on a reference list, as NDCs vary from one labeler to another, from one package size to another and from one time period to another.

Exception: There is no requirement for an NDC when billing for vaccines.

C. Claims Filing

The HCPCS/CPT codes billing units and the NDC quantity do not always have a one-to-one relationship.

Example 1: The HCPCS/CPT code may specify up to 75 mg of the drug, whereas the NDC quantity is typically billed in units, milliliters or grams. If the patient is provided 2 oral tablets, one at 25 mg and one at 50 mg, the HCPCS/CPT code unit would be 1 (1 total of 75 mg) in the example, whereas the NDC quantity would be 1 each (1 unit of the 25 mg tablet and 1 unit of the 50 mg tablet). See Diagram 3.

Diagram 3

Click here to view image

Example 2: If the drug in the example is an injection of 5 ml (or cc) of a product that was 50 mg per 10 ml of a 10 ml single-use vial, the HCPCS/CPT code unit would be 1 (1 unit of 25 mg) whereas the NDC quantity would be 5 (5 ml). In this example, 5 ml or 25 mg would be documented as wasted.

Diagram 4

Click here to view image

D. Electronic Claims Filing 8371 (Outpatient)

Procedure codes that do not require paper billing may be billed electronically. Any procedure codes that have required modifiers in the past will continue to require modifiers.

Arkansas Medicaid will require providers using Provider Electronic Solutions (PES) to use the required NDC format when billing HCPCS/CPT codes for administered drugs.

E. Paper Claims Filing CMS-1450 (UB-04)

Arkansas Medicaid will require providers billing drug HCPCS/CPT codes, including covered unlisted drug procedure codes, to use the required NDC format.

For institutional outpatient claims on the CMS-1450 (UB-04), use the locator field 43 (Description) to list the qualifier of "N4," the 11-digit NDC, the unit of measure qualifier (F2 - International Unit; GR - Gram; ML - Milliliter; UN - Unit) and number of units of the actual NDC administered, spaced and arranged exactly as in Diagram 5. Each NDC when billed under the same procedure code on the same date of service is defined as a "sequence." When billing a single HCPCS/CPT code with multiple NDCs as detail sequences, the first sequence should reflect the total charges in detail locator field 47 and total HCPCS/CPT code units in locator field 46. Each subsequent sequence number should show zeros in locator fields 46 and 47. See Detail 1, sequence 2 in Diagram 5. The quantity of the NDC will be the total number of units billed for each specific NDC. See Diagram 5, first detail, sequences 1 and 2. Detail 2 is a Procedure Code that does not require an NDC. Detail 3, sequence 1 gives an example where only one NDC is associated with the HCPCS/CPT code.

Diagram 5

Click here to view image

F. Procedure Code/NDC Detail Attachment Form- DMS-664

For drug HCPCS/CPT codes requiring paper billing (i.e., for manual review), complete every field of the DMS-664 "Procedure Code/NDC Detail Attachment Form." Attach this form and any other required documents to your claim when submitting it for processing. See Diagram 6 for an example of the completed form. View or print form DMS-664 and instructions for completion.

Diagram 6

Click here to view image

G. Adjustments

Paper adjustments for paid claims filed with NDC numbers will not be accepted. Any original claim will have to be voided and a replacement claim will need to be filed. Providers have the option of adjusting a paper or electronic claim electronically.

H. Remittance Advices

Only the first sequence in a detail will be displayed on the remittance advice reflecting either the total amount paid or the denial EOB(s) for the detail.

I. Record Retention

Each provider must retain all records for five (5) years from the date of service or until all audit questions, disputes or review issues, appeal hearings, investigations or administrative/judicial litigation to which the records may relate are concluded, whichever period is longer. At times, a manufacturer may question the invoiced amount, which results in a drug rebate dispute. If this occurs, you may be contacted requesting a copy of your office records to include documentation pertaining to the billed HCPCS/CPT code. Requested records may include NDC invoices showing the purchase of drugs and documentation showing what drug (name, strength and amount) was administered and on what date, to the beneficiary in question.

See Section 272.510 for additional information regarding National Drug Code (NDC) billing.

A. Multiple units may be billed when applicable. Take home drugs are not covered. Drugs loaded into an infusion pump are not classified as "take-home drugs." Refer to payable CRT code ranges 96365 through 96379.

B. When submitting Arkansas Medicaid drug claims, drug units should be reported in multiples of the dosage included in the HCPCS procedure code description. If the dosage given is not a multiple of the number provided in the HCPCS code description, the provider shall round up to the nearest whole number in order to express the HCPCS description number as a multiple.

See Section 272.102 for additional information regarding National Drug Code (NDC) billing.

See Section 272.450 for special billing instructions and coverage of Radiopharmaceuticals.

For coverage information regarding any drug not listed, please contact the Medicaid Reimbursement Unit. View or print Medicaid Reimbursement Unit contact information.

The following is a list of injections with special instructions for coverage and billing:

Tables of Payable Procedure Codes

The tables of payable procedure codes are designed with eight columns of information.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: A9542 - A9545 require the Federal Drug Administration (FDA) approved diagnosis clearly stated. Treatment failures that the patient previously experiences and the patient's history and physical examination must be submitted.

NOTE: Prior Approval is required before services associated with the use of the procedure code must be provided. To obtain Prior Approval, a copy of the patient's history and physical exam must be submitted along with a report of the ultrasound or computerized axial tomography (CAT) that was not diaanostic.

NOTE: To obtain Prior Approval, a copy of the patient's history and physical exam must be submitted along with a report on what other profusion scans have been tried and are nondiagnostic and attach a copy of the manufacturer's invoice to the claim.

NOTE: Attach the manufacturer's invoice to the claim.

NOTE: Attach the manufacturer's invoice to the claim.

NOTE: Attach the manufacturer's invoice to the claim.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Attach the manufacturer's invoice to the claim.

NOTE: Attach the manufacturer's invoice to the claim.

NOTE: Attach the manufacturer's invoice to the claim.

NOTE: Kcentra is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKZ, e.g. warfarin) therapy in adult patients with major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding. Documentation of the major bleed should be included in a complete history and physical exam. All treatments needed for the major bleed prior to Kcentra should be documented. A hemoglobin and hematocrit should be documented in the record as well as the dose of warfarin.

NOTE: Coverage of procedure code C9257 is for ages 21 years and above with a diagnosis code of 362.02, 362.07, 362.16, 362.26, 362.29, 362.35, 362.52, 364.42 or 365.63. Documentation included with Prior Approval Letter request must include Fluorescein angiogram or OCT, patient screen for conditions that would contraindicate the use of Avastin, and documentation of patient consent.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042,140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia, in adult patients who have intolerance to oral iron, have had an unsatisfactory response to oral iron or who have non-dialysis dependent chronic l[LESS THAN]idney disease. Patients must have a history and physical exam documenting kidney disease or iron deficiency anemia with intolerance to oral iron. Patients must have lab values showing no increase in iron studies or hemoglobin after administration of oral iron.

NOTE: Patient must have had inadequate response to one or more disease-modifying antirheumatic drugs such as Methotrexate or Tumor Necrosis Factor antagonists (Humira, Remicade, etc.). Records submitted with claim must include history and physical exam showing severity of rheumatoid arthritis, treatment with disease-modifying anti-rheumatic drugs and treatment failure resulting in progression of joint destruction, swelling, tendonitis, etc.

NOTE: Maximum units allowed are 4 per day.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Eyiea should only be administered by a retinal specialist or other physician trained in retinal care. Contraindicated in ocular or periocular infections, active intraocular inflammation and hypersensitivity. Intravitreal injections have been associated with endophthalmitis and retinal detachments. Patients should be instructed to report any symptoms as soon as possible. Patients should be monitored for 60 minutes after injection due to acute increases in intraocular pressure seen with EyIea Injections. There is a potential risk of arterial thromboembolic events following use of this class of drugs. Patients should be screened for risk factors of stroke, myocardial infarction or vascular events. Submit screening history to the Medical Director for Clinical Affairs as well as OCT or fluorescein angiogram to evaluate lesion type, location and size and presence of subretinal fluid. The medical record must contain the actual dosage, site, lot number of the vial, date and time of administration and any unusual reactions. All of this must be submitted to the Medical Director for Clinical Affairs for a Prior Approval letter.

NOTE: Evaluation by a physician with a specialty in clinical genetics documenting progress required annually.

NOTE: Payable for beneficiaries who have the primary detail diagnosis of late onset, not infantile, Pompe disease. The history and physical by a geneticist showing a diagnosis of late onset, not infantile, Pompe disease must be submitted with the request for the prior approval letter. The beneficiary, physician and infusion center should be enrolled in the Lumizyme ACE Program. The history and physical should document compliance with this program including discussion of the risks of anaphylaxis, severe allergic reactions and immune-mediated reactions according to the Black Box Warning from the FDA. This drug should only be administered in a facility equipped to deal with anaphylaxis, including Advanced Life Support capability.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated In the age restriction column.

NOTE: This drug or other drugs in this class are only approved for the diagnosis of alpha 1-

proteinase (antitrypsin) deficiency with clinically evident emphysema. Levels of alpha 1-proteinase must be clearly documented in the chart. Alpha 1 antitrypsin concentrations should be less than 80 mg per deciliter (mg/dl). The medical record should contain a history and physical exam documenting this disease with clear clinical evidence of emphysema. Obstructive lung disease, emphysema, is defined by a forced expiratory volume in one second (FEV1) of 30-65% of predicted or a rapid decline in lung function as defined as a change in FEV1 of greater than 120 ml/year. The patient should be a nonsmoker. The dosage, frequency, site of administration and duration of the therapy should be reasonable, clinically appropriate and supported by evidence-based literature and adjusted based upon severity, alternative available treatments and previous response to alpha 1 proteinase Inhibitor (Human) therapy for the condition addressed. Coverage for deficiency-associated liver disease without emphysema, cystic fibrosis and diabetes mellitus is considered experimental and is not approved. Therapy should maintain alpha 1 antitrypsin levels above 80 mg/dl. Due to risk of anaphylaxis, this drug must be given in an infusion center with immediate access to a physician trained in the treatment of this reaction. The only other approved infusion would be by a specially trained nurse who has immediate access to treatment for anaphylaxis and is trained in this special situation.

NOTE: Procedure code J0348 is valid for any condition below, along with ICD-9-CM diagnosis code of 112.5 or 112.8 (and any valid 5th digits), or 112.9 (1) End-stage Renal Disease (ICD-9-CM codes 584 - 586) or (2) AIDS or cancer (List 003) or (3) Post transplant status (i.e., ICD-9-CM diagnosis code 986.80-996.89) or specify transplanted organ and transplant date.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: This drug is indicated for treatment of patients age 18 years and above witii active,

autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy, such as non-steroidal anti-inflammatory drugs, hydroxychloroquine, corticosteroids or immunosuppressive drugs. Use of this drug is not recommended for use in combination with other biologies or intravenous cyclophosphamide, or patients with severe active lupus nephritis, or severe active central nervous system lupus. This drug administration requires a prior approval letter which must include a history and physical exam documenting all prior treatment and documented failure of treatment. The patient should continue to receive the standard therapy. This drug should be administered by healthcare providers prepared to manage anaphylaxis and must be prescribed by a rheumatologist.

NOTE: Botox A is reviewed for medical necessity based on ICD-9-CM diagnosis code.

NOTE: This procedure code is reviewed for medical necessity based on an ICD-9-CM diagnosis code billed.

NOTE: An ICD-9-CM diagnosis code which supports medical necessity is required.

*Procedure cx)de requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: This code will be reviewed for medical necessity based on the clinical documentation submitted.

NOTE: Procedure code J0637 is covered when administered to patients with refractory aspergillosis who also have a diagnosis of malignant neoplasm or HIV disease. Complete history and physical exam, documentation of failure with other conventional therapy and dosage. After 30 days of use, an updated medical exam and history must be submitted.

NOTE: Approved Only:

NOTE: Simponi is a tumor necrosis factor (TNF) blocker indicated in the treatment of adults with:

Medical documentation of physician history and physical exam with records showing failed trial of Humira and Enbrel as indicated should also be submitted.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless othenMse indicated in the age restriction column.

NOTE: Arkansas Medicaid will reimburse providers for 17-Hydroxyprogesterone Caproate, 1 mg per day under J1725 at a maximum of 250 units per day. J1725 will be covered for females, ages 16 years and above, when a singleton pregnancy exists and a history of pre-term labor is present. This drug may be administered every 7 days, with treatment initiated between 16 weeks, 0 days and 20 weeks, 6 days and continued until week 37 for delivery. J1725 may be billed electronically or on a paper claim (CMS-1500 or CMS-1450), with a primary ICD-9-CM diagnosis code of V23.41, "Pregnancy with history of pre-term labor." J1725 requires NDC billing protocol. The administration fee for 17-Hydroxyprogesterone Caproate is included in the reimbursement fee allowed for this drug.

NOTE: An evaluation by a physician with a specialty in clinical genetics documenting progress and response to the medication is required annually.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless othen/i/ise indicated in the age restriction column.

NOTE: J1745 is payable without an approval letter for beneficiaries under age 18 years when the ICD-9-CM diagnosis is 555.0, 555.1 or 555.9. No other diagnosis is required. All other diagnoses for beneficiaries under age 18 year require a Prior Approval Letter.

For beneficiaries age 18 years and above, J1745 is payable when one of the following conditions exist:

ICD-9-CM diagnosis code 555.9 as the primary detail diagnosis AND a secondary diagnosis of 565.1 or 569.81

OR

ICD-9-CM diagnosis code range 556.0 - 556.9

OR

ICD-9-CM diagnosis code 696.0

OR

ICD-9-CM diagnosis code 714.0

ICD-9-CM diagnosis code 714.0 requires a Prior Approval Letter from the IVIedical Director for Clinical Affairs. The request for approval must include documentation showing failed trial of Enbrel or Humira.

Claims must be submitted with any applicable attachments and will be manually reviewed prior to payment.

OR

ICD-9-CM diagnosis code 724.9.

ICD-9-CM diagnosis code 724.9 requires a Prior Approval Letter from the Medical Director for Clinical Affairs. The request for approval must include documentation showing failed trial of Enbrel or Humira.

Claims must be submitted with any applicable attachments and will be manually reviewed prior to payment.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes Include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12, Diagnosis List 003 restrictions apply to ages 21 y and above unless othenMse indicated in the age restriction column.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. {See Section 272.102 for NDC

protocol),

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless otherwise indicated in the age restriction column.

NOTE: The history and physical showing a relapse of multiple sclerosis must be submitted with the request for the Prior Approval Letter.

NOTE: A Prior Approval Letter is required for a diagnosis other than a List 003 diagnosis.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Procedure code J2505 is payable for beneficiaries of all ages with a detail diagnosis from valid ICD-9-CM diagnosis code ranges 162.0-165.9 or 174.0-175.9 or 201.00-201.98 or 202.80-202.88, 288.00-288.04, 288.09 or 288.4 or 288.50-288.51 or 288.59, 289.53, V58.69, \/67.51, V58.11, V66.2 and E933.1 are covered along with a diagnosis of AIDS or cancer (List 003). Diagnosis codes must be shown on the claim form.

NOTE: The submitted medical documentation should include a history and physical exam that demonstrates that the beneficiary has failed all other treatments for gout due to progression of disease or intolerable side effects. This drug should only be administered in tiealth care settings and by physicians prepared to manage anaphylaxis and infusion reactions. Premedication should be administered and the patient should be watched for any reaction after infusion. It is not recommended for the treatment of asymptomatic gout.

NOTE: Procedure code J2562 is covered for ages 21 years and above and requires prior authorization by the Arl[LESS THAN]ansas Foundation for Medical Care (AFMC). Prior authorization will be provided by a telephone review. Approval is granted in conjunction with the use of granulocyte-colony stimulating factor to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with Non-Hodgkin's lymphoma and multiple myeloma. Applicants will only be considered for approval if a transplant has been approved by AFMC. There must be documentation of failure to mobilize cells with conventional therapy for consideration of this drug. The drug will only be approved for four doses; one daily, times four days. The total dosage for the four days must be indicated at the time of the request.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless otherwflse indicated in the age restriction column.

NOTE: Beneficiaries must have failed corticosteroids, immunoglobulins or have had a splenectomy. Beneficiaries must have thrombocytopenia and a clinical condition that causes increased risk of bleeding.

Romiplostim is not to be used to normalize platelet counts.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instnjctions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless othenMse Indicated in the age restriction column.

NOTE: For the purpose of declotting catheters, bill diagnosis 996.74 on the claim.

NOTE: For the purpose of declotting catheters, bill diagnosis 996.74 on the claim.

NOTE: This procedure code is indicated for a diagnosis of Type 1 Gaucher Disease. A complete history and physical exam with a complete evaluation by a geneticist is required each year. This exam must include the prognosis and all abnormalities associated with Gaucher Disease.

NOTE: Ages 0-20 years have no restrictions.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: The patient must have tried and failed therapy with documented progression of symptoms on Humira and Enbrel prior to the request for this drug. The physician medical record must document a history and physical examination that clearly shows failure of Humira and Enbrel with submission for a prior approval letter. Doses exceeding 800 mg per infusion will not be approved, as they are not recommended. The physician must follow all Food and Drug Administration (FDA) recommendations on monitoring of laboratory and serious infections.

NOTE: There must be clear documentation that the patient has failed Humira and Enbrel, with documentation of progression of the disease or documented inability to tolerate Humira and Enbrel. A physician history and physical must be submitted with a request for prior approval letter. Documentation of patient counseling of the adverse effects of the drug should also be included. This drug should only be administered to patients who will be closely monitored and have regular follow-up visits by a physician.

NOTE: Covered for pediatric and adult beneficiaries who are symptomatic and require enzyme replacement therapy. A history and physical exam by a geneticist is required yearly for approval. The history and physical exam should document the prognosis of the patient as well as current symptoms.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless othenwse indicated in the age restriction column.

NOTE: Procedure code J3465 is covered for non-pregnant beneficiaries.

NOTE: Requires a paper claim form with the name of the drug, dosage and the route of administration for consideration for eligible beneficiaries. Clinical documentation may be required. See Section 252.111 for additional billing infomiation.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless otherwise indicated in the age restriction column.

NOTE: Arkansas Medicaid will reimburse providers for "Compounded 17-Hydroxyprogesterone Caproate, 250 mg" per day under J3490-U9. It will be covered for females, ages 16 years and above, when a singleton pregnancy exists and a history of pre-term labor is present. "Compounded 17-Hydroxyprogesterone Caproate 250 mg" may be administered every 7 days, with treatment initiated between 16 weel[LESS THAN]s, 0 days, and 20 weeks, 6 days, and continued until week 37 for delivery. J3490-LI9 may be billed electronically or on a paper claim (CMS-1500 orCMS-1450), with a primary ICD-9-CM diagnosis code of V23.41, "Pregnancy with history of pre-term labor." J3490-U9 is exempt from NDC billing protocol. The administration fee for "Compounded 17-Hydroxyprogesterone Caproate, 250 mg" is included in the reimbursement fee allowed for this drug. The U9 modifier must always accompany this procedure code when referring to "Compounded 17-Hydroxyprogesterone Caproate 250 mg."

NOTE: For consideration, procedure code J7199 must be billed on a paper claim forni with the name of the drug, dosage and the route of administration. See Section 252.111 for billing instructions.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Covered for therapeutic use and treatment of heavy menstrual bleeding in women who have had a child or who have been pregnant.

NOTE: Procedure code J7312 is covered for the allowable valid ICD-9-CM diagnosis codes when the beneficiary has failed oral treatments and is untreatable by any other method. There should be documentation of vein occlusion and studies documenting macular edema. Visual acuity should be noted after the vein occlusion or after failed treatments for uveitis. The patients should be monitored after the injection for elevation in intraocular pressure and endophthalmitis. Counseling of side effects should be documented in the medical record. The history and physical exam including all tests should be sent with the request for prior approval letter.

NOTE: Jetrea is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion. Immediately following the injection the patient must be monitored for elevation in intraocular pressure. The dose, lot number and manufacturer must be documented. A complete history and physical with visual exam including visual acuity must be submitted with the request for a prior approval letter.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042,140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21 y and above unless otherwise indicated in the age restriction column.

NOTE: Prior authorization is required for coverage of the Hyaluronon injection for outpatient hospital providers. Providers must specify the brand name of Hyaluronon (sodium hyaluronate) or derivative when requesting prior authorization for this procedure code. A written request must be submitted to the Division of IVIedical Services Utilization Review Section. The request must include the patient's name, l\/1edicaid ID number, physician's name, physician's Arkansas Medicaid provider identification number, patient's date of birth and medical records that document the severity of osteoarthritis, previous treatments and site of injection. Hyaluronon is limited to one injection or series of injections per knee, per beneficiary, per lifetime.

A maximum of three injections per knee are allowed of Hylan polymers that are covered by Arkansas Medicaid. If additional injections are administered as part of the initial series, the cost of the additional injections is considered a component of the other approved unit(s) of these injection procedures. Refer to Section 245.031 for Prior Authorization.

NOTE: Procedure code J7330 requires prior authorization from AFMC for all providers. See Section 241.000 for more information on obtaining prior authorization from AFMC.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: For consideration, procedure code J7525 must be billed on a paper claim form with the name of the drug, dosage and the route of administration.

NOTE: For consideration, procedure code J7599 must be billed on a paper claim form with the name of the drug, dosage and the route of administration. See Section 252.111 for billing instructions.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Adcetris - After failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. It is also indicated for patients with systemic anaplastic large cell lymphoma, ICD-9-CM diagnosis 200.6 after failure of at least one prior multi-agent chemotherapy regimen. Documentation of above criteria must be submitted with current history and physical exam for Prior Approval letter from the Medicaid Director for Clinical Affairs. All previous chemotherapy regimens should be well documented in records submitted. Reasons why patient is not an ASCT candidate should be clearly documented. A treatment cycle maximum of 16 cycles will only be approved. Infusions should only be done in centers with knowledgeable physicians readily available to treat infusion reactions. Patients should be closely monitored for evidence of Progressive Multifocal Leukoencephalopathy (PML) and should be counseled on signs and symptoms. Discussion of risk of PML should be documented in medical records.

NOTE: This drug is indicated to be used in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with decetaxel-containing treatment regimen. This must be well documented in a history and physical exam submitted for prior approval letter. Failure of previous chemotherapy must be well documented. Physicians must be able to manage hypersensitivity reactions appropriately in the setting of the infusion.

'Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042,140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Kyprolis is indicated for the treatnnent of adult patients witli multiple myeloma, who have received at least two prior therapies including Velcade and an immunomodulary agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based upon response rate. A physical exam and history documenting the above requirements must be included. All monitoring and warnings and precautions from the Federal Drug Administration must be complied with for this drug to be approved. Females should avoid becoming pregnant. Consideration will be on a case-by-case basis.

NOTE: Covered for male beneficiaries only.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042,140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: This procedure code is only approved for treatment of metastatic breast cancer in patients wiio have previously received at least two chemotherapy regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. A complete history and physical exam is required documenting all prior treatments and the failure of therapy. This drug should only be given by physicians wfio are well versed in the use of chemotherapy and treatment of any side effects.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: For male beneficiaries of all ages. Benefit limit is one procedure every 12 months.

NOTE: Suppreiin LA: Prior to initiation of treatment, a clinical diagnosis of GPP, ICD-9-CM code 259.1, should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor) and adrenal steroids to exclude congenital adrenal hyperplasia. All tests and screenings must be documented by medical records and submitted with history and physical examination when requesting prior approval.

*Procedure code requires paper billing with applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include; 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column,

NOTE: Ipilimumab is indicated for the treatment of unresectable or metastatic melanoma. It should be given every 3 weeks for a total of four doses. Liver function tests, thyroid function tests and clinical chemistries must be monitored before each dose. The genetic test for BRAF V600E mutation should be done on all patients to determine whether they are candidates for Zelboraf. If positive for the mutation, the patient should first be given a trial of Zelboraf. If the patient fails the trial or does not have the mutation, then they should be considered for Ipilimumab. Ipilimumab should only be prescribed by physicians who are prepared to treat immune mediated complications. Participation in the risl[LESS THAN] evaluation and mitigation program is essential. Use of Ipilimumab requires a detailed history and physical exam including all previous treatments and clear documentation that the melanoma is not treatable by surgery or has metastasized. Patients considered for treatment with Ipilimumab should be at least 18 years old and have a life expectancy of at least 4 months and have previously been treated with either dacarbazine, temozolomide, carboplatin or interleukin-2. If not treated first with one of these drugs, a detailed letter of medical necessity documenting the reasons for not treating the patient with one of these drugs first is required.

NOTE: The disease must have not responded to, or either has relapsed, following treatment with at least 2 chemotherapy regimens.

NOTE: Synribo is indicated for treatment of adult patients with chronic or accelerated chronic myeloid leukemia with resistance and/or tolerance to two or more tyrosine inhibitors. A history and physical exam documenting previous treatment should be submitted with the request for a prior approval letter.

*Procedure code requires paper billing with applicable attacliments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042, 140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless otherwise indicated in the age restriction column.

NOTE: Requires iCD-9-CM diagnosis code for cancer or ICD-9-CM diagnosis code of 340.

NOTE: Perjeta is an agent for tiie treatment of adults, age 18-99 years old, tliat is a Her2/neu receptor antagonist indicated in combination with tratuzumab and docetaxol for the treatment of patients with Her2-positive metastatic breast cancer who have not received prior anti-Her2 therapy or chemotherapy for metastatic disease. A physician history and physical exam documenting all previous treatment should be included. All Federal Drug Administration warnings and precautions should be followed.

*Procedure code requires paper billing witfi applicable attachments and must follow NDC protocol. (See Section 272.102 for NDC

protocol).

See Section 241.000 for prior authorization procedures.

See Section 272.103 for instructions regarding obtaining a Prior Approval Letter.

List 003 diagnosis codes include: 042,140.0-209.36, 209.70-209.75, 209.79, 230.0-238.9, 511.81 or V58.11-V58.12. Diagnosis List 003 restrictions apply to ages 21y and above unless othenwise indicated in the age restriction column.

NOTE: Tine diagnosis must be for:

* Newly diagnosed glioblastoma multiform treated concomitantly with radiotlierapy OR

* As maintenance treatment for refractory anaplastic astrocytoma in patients who have disease progression on nitrosourea and procarbazine

NOTE: Kadcyla is a Her2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of adults with Her2-positive, metastatic breast cancer, who previously received traztuzumab and a taxane, separately or in combination. Patients should have either: