Physician-Administered Drugs (PAD) Billing Manual

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Physician-Administered Drug Requirements and Benefits

This Physician Administered Drug (PAD) billing manual explains many of the Colorado Department of Health Care Policy & Financing's (the Department) policies regarding billing, reimbursement, and program benefits.

PADs are medications that require administration in an office or clinic under medical supervision such as injectable, intravenous, and implantable medications and are billed as professional medical claims. Providers that render PADs must be enrolled as a provider with Health First Colorado. PAD claims are billed to and paid by the Department's fiscal agent. For additional information on billing PADs and requirements, please refer to the Health First Colorado General Provider Information Manual.

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1990 OBRA Rebate Program

Federal regulation requires that drug manufacturers sign a national rebate agreement with the Centers for Medicaid and Medicare Services (CMS) to participate in Health First Colorado. Drugs produced by companies that have signed a rebate agreement (participating companies) are generally a Health First Colorado benefit but may be subject to restrictions. Health First Colorado does not provide reimbursement for products by manufacturers that have not signed a rebate agreement.

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Timely Filing

Refer to the Health First Colorado General Provider Information Manual.

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Retention of Records

Source documents and source records used to create PAD claims shall be maintained in such a way that all electronic media claims can be readily associated and identified. These source documents, in addition to any work papers and records used to create electronic media claims, shall be retained by the provider for seven years and shall be made readily available and produced upon request of the Secretary of the Department of Health and Human Services, the Department, and the Medicaid Fraud Control Unit and their authorized agents.

HCPCS/NDC Crosswalk

An updated Healthcare Common Procedure Coding System (HCPCS)/ National Drug Code number (NDC) Crosswalk is provided twice per month to provide billing guidance on PADs and posted under Appendix X. Appendix X is generally updated on the first and 15th of each month excluding holidays and weekends, when it is updated on the subsequent workday. The Crosswalk is utilized to process PAD claims. The Crosswalk provides information as to valid HCPCS/NDC combinations and date spans for when each combination is valid. The drug must be listed accordingly on the Crosswalk to be a covered benefit.

Not all HCPCS/NDC combinations listed on the Crosswalk are a part of the PAD Benefit. Providers may reference the appropriate billing manual and fee schedule as noted by the information provided in the Benefit Descriptor column on the Crosswalk. Crosswalk combinations noted as PHARM may be covered by either the PAD or Pharmacy Benefit, depending on place of administration. The Pharmaceutical Benefit Help Guide may be referenced for appropriate benefit billing guidance.

Inquiries for HCPCS/NDC combinations to potentially be added to the Crosswalk, please send the following information for each record requested to HCPF_PAD@state.co.us:

HCPCS code

HCPCS description

NDC in 11-digit format

NDC description  

Records may take up to two fiscal quarters to be added to the Crosswalk and will only be effective for dates of service which fall within the listed date span(s).

Note that if a PAD claim is billed without a valid HCPCS/NDC combination listed on the Crosswalk or the HCPCS/NDC billed on a PAD claim is determined not to be a covered benefit, the claim line will be denied. 

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New Drugs

Coverage for new drugs will be determined by the Department. New drugs without an assigned HCPCS code require billing with the appropriate miscellaneous HCPCS code. Drugs that have been assigned a temporary C code must be billed with the assigned temporary code when administered in the outpatient hospital setting. The Crosswalk and the PAD Fee Schedule should be referenced prior to administration of a new drug to ensure that the PAD is a covered benefit. If a drug is administered to a member but is not listed on the Crosswalk and PAD Fee Schedule:

  1. The claim line may not be reimbursed until a coverage determination is made.
  2. The claim line will not be reimbursed if it is determined that the PAD is not a covered benefit.
  3. The claim line will deny if there is no listed rate on the PAD Fee Schedule. PAD rates are not usually retroactive, as they are set quarterly and in conjunction with ASP rates (See Payment Methodology).
  4. A new drug may be subject to prior authorization requirements. 
    • The claim line will be denied if there is not an approved prior authorization on file prior to the treatment being rendered (See ‘PAD Prior Authorization Requirements’). 

Once a permanent HCPCS has been assigned to the drug, the provider must submit claims with the permanent HCPCS code. Any claims submitted with a temporary C code or miscellaneous J code after a drug has been assigned a permanent HCPCS code will be denied.

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Acceptable Use

Providers must ensure a PAD is being used for a U.S. Food and Drug Administration (FDA) approved indication or an indication that is supported by certain compendia identified in section 1927(g)(1)(B)(i) of the Social Security Act.

Exclusions

The following are not benefits of the Health First Colorado program:

  • DESI drugs and any drug if by its generic makeup and route of administration, it is identical, related, or similar to a less than effective drug identified by the FDA
  • Drugs classified by the U.S.D.H.H.S. FDA as "investigational" or "experimental"
  • Drugs manufactured by pharmaceutical companies not participating in the Colorado Medicaid Drug Rebate Program
  • Fertility drugs
  • IV equipment (for example, Venopaks dispensed without the IV solutions)
  • Personal care items such as mouth wash, deodorants, talcum powder, bath powder, soap (of any kind), dentifrices, etc.
  • Spirituous liquors of any kind
  • Drugs used for erectile or sexual dysfunction

The following are not PAD benefits of the Health First Colorado program:

  • Durable Medical Equipment (DME), these are managed through the DME benefit, refer to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Billing Manual
  • PADs when administered in a member's home or in a long-term care (LTC) facility, or when self-administered must be billed to the Pharmacy Benefit.
  • Some PADs may be billed to the Pharmacy Benefit when administered in the pharmacy (See ‘Pharmacy Billing Requirements’ below and the Pharmacist Services Billing Manual)

Early and Periodic Screening, Diagnostic, and Treatment (EPSDT)

All information pertaining to EPSDT can be found in the Health First Colorado General Provider Information Manual.

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PAD Prior Authorization Information

Effective January 18, 2022, a select number of PADs are subject to prior authorization (PA) requirements. All PAD PA policies and procedures can be found on the PAD Resources webpage.
 
Providers must: 

  • Submit a PA request to the utilization management (UM) vendor for any member receiving any of the PADs listed in Appendix Y: Physician Administered Drug Medical Benefit Prior Authorization Procedures and Criteria, under Fee-for-Service Physician-Administered Drugs dropdown. 
  • Ensure that an approved PA is on file prior to PAD administration and that there is an approved PA on file for each of the PADs requiring a PA which the member receives. 
  • Follow all General Provider and PAD billing policies found in the respective billing manuals located on the Billing Manuals webpage.

Approval of a PA request (PAR) does not guarantee Health First Colorado payment. 

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Outpatient Hospital Specialty Drug Policy

PADs associated with the Outpatient Hospital Specialty Drug carve-out require prior authorization; coverage standards and requirements can be found on the PAD Resources web page (located under the ‘Outpatient Hospital Specialty Drugs- EAPG Carveout’ dropdown). Additional information is provided in the IP and OP Hospital Billing Manual. All outpatient hospital specialty drugs are listed on Appendix Z.

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Units Requested on the PA

When submitting a PAR, providers must request the total number of units appropriate and necessary for the course of the treatment to be covered by the PA and as indicated for the specified diagnosis. 

The requested units shall not include waste or discarded drug from single or multi-use vials nor should a PA be requested for any PAD not purchased directly by the provider.

For Health First Colorado-only members, the Department does not pay for wasted drug from single or multi-use vials; a provider must bill only for the amount of drug administered to the member. For members having both Health First Colorado and Medicare (dual-eligible), a provider may bill for wasted drug on a second line with the JW modifier on Medicare Part B Crossover claims only.   

Additional guidance on unit calculation and billing policies can be found in the Claim Submission Requirements in this PAD billing manual.

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Retroactive PARs

Retroactive authorizations are not allowed, with few exceptions due to extenuating circumstances.

Exceptions are granted only when the provider is able to document that appropriate action was taken to meet the submission requirements and that the provider was prevented from requesting the PA as the result of extenuating unforeseen and uncontrollable circumstances. Requests for retroactive authorization must contain a detailed description of the circumstance that was beyond the control of the provider. 

Office/clinic employee negligence, employer failure to provide sufficient, well-trained employees or failure to properly monitor the activities of employees and agents (e.g., billing services) are not considered extenuating circumstances beyond the provider's control. 

A detailed description and applicable documentation of the extenuating circumstances must be included in the request for retroactive authorization.

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PA Submission

When submitting a PAD PAR, the servicing provider is the billing provider. If entering the rendering/administering provider as the servicing provider, there may be instances where the rendering provider type is producing a PAR submission error or may result in a denied claim. Please ensure the billing provider (typically the clinic/office) is entered on the PAR as the servicing provider to successfully submit the PAR and to avoid subsequent PAD claims processing issues. 

For any approved PAR on file in which the billing provider was not entered as the servicing provider, please complete the following steps for the pertinent scenario to ensure the information on the PAR is accurate and to avoid PAD claims processing issues:

  1. There has been at least one claim billed on the PA
    1. Submit a new PA request
    2. Add a note to include:
      1. A description of the error
        1. Previous PA was approved with incorrect provider listed as the servicing provider
      2. Your request to end-date the previous PA and include the case ID
  2. There have been no claims billed on the PA
    1. File a revision request on the submitted PAR in Atrezzo
    2. Follow the instructions for How to Make Revisions to Submitted Request

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Coordination of Benefits (COB)- PA requirements for Health First Colorado members who have Medicare coverage (dually eligible) and members with other Third-Party Liability (TPL) health insurance coverage

Dually Eligible Members

When a PAD listed on Appendix Y meets criteria for a local coverage determination (LCD) and/or a national coverage determination (NCD) and is billed to Medicare as primary and Health First Colorado secondary, no PA is needed and PAR submission is not required. 

Other TPL 

Providers must submit a PAR to Kepro for any PAD listed on Appendix Y when a member has additional TPL health insurance coverage, other than Medicare. Kepro will process a PAR according to the criteria on Appendix Y and notify the provider of the determination per all PAD PA policy and procedure requirements.

  • The requesting provider must submit a PAR to Kepro, regardless of the TPL PA determination and must include:
    • Any and all determination letters and clinical documentation 
    • A note of the approval or denial made by TPL 

Any guidance regarding PA requirements related to COB issued prior to May 1, 2022 will not be considered and all members with TPL will require a prior authorization.

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Payment Methodology

Rates for PADs are updated on a quarterly basis and published on the PAD Fee Schedule. PADs listed as manually priced (MP) on the PAD Fee Schedule require the drug invoice to be attached to the claim, manually priced PADs are reviewed and priced by the fiscal agent.

Effective July 1, 2017, PADs with a published Medicare Average Sales Price (ASP) are paid at the lower of the published ASP minus 3.3 percent or submitted cost. Any PAD for which a published ASP does not exist is paid at either the lower of the submitted cost or the wholesale acquisition cost (WAC). As of November 26, 2019, reimbursement for injectable opioid antagonist was modified to pay at the lower of the published ASP plus 2.2 percent or the submitted cost. Any PAD dispensed by a pharmacy and billed to the Medical Benefit are subject to this methodology.

Other Methodologies

PADs dispensed by and billed to the Pharmacy Benefit are reimbursed according to the Pharmacy Rate List.

PAD claims for Inpatient Hospital (IP) services are reimbursed by Health First Colorado on a prospective basis using a Diagnosis Related Group (DRG) method. Claims with a discharge date on or after January 1, 2014 are reimbursed using the All-Patient Refined DRG (APR-DRG). PAD claims for Outpatient Hospital (OP) services are reimbursed by Health First Colorado using the Enhanced Ambulatory Patient Grouping (EAPG) methodology. For additional information, refer to the Inpatient/Outpatient (IP/OP) Billing Manual.

Certain PADs administered in the OP Hospital setting may be subject to reimbursement outside of the EAPG methodology and require prior authorization. For an updated list, refer to the Inpatient/Outpatient (IP/OP) Billing Manual and Appendix Z.

Professional Medicare Crossover claims billed with a miscellaneous J code are reimbursed with the following methodology: if (Medicare paid amount plus Co-pay) is less than or equal to (WAC multiplied by the number of NDC units), then claim pays at the Co-pay amount. If (Medicare paid amount plus Co-pay) is greater than (WAC multiplied by the number of NDC units), then the claim pays at [(WAC multiplied by the number of NDC units) minus Medicare paid amount]. Any negative calculation amounts pay at zero.

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Wasted Drug

For Health First Colorado-only members, the Department does not pay for wasted drug from single or multi-use vials, a provider must bill only for the amount of drug administered to the member. For members having both Medicare and Health First Colorado (dual-eligible), a provider may bill for wasted drug on a second line with the JW modifier on Medicare Part B Crossover claims for single use vials only.

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Pharmacy Billing Requirements

In some instances, a pharmacy may need to dispense PADs. For any PAD which will be administered by a health care professional in the home or at a long-term care facility, the pharmacy must bill the pharmacy benefit manager (PBM). This process may require the appropriate place of service billing code and/or a prior authorization. Refer to the Pharmacy Resources web page for all pharmacy billing policies and guidance.

Medicare Part B Crossover claims for PADs within specific drug classes not dispensed "incident to" a physician service may be billed by the pharmacy to the medical benefit. The dispensing pharmacy must be enrolled as a Health First Colorado provider under the Pharmacy (provider type 09) with Durable Medical Equipment (DME) (provider specialty 462) and bill the medical benefit Supply contract. Such drug classes include immunosuppressive drugs, oral anti-emetic drugs, oral anti-cancer drugs, and drugs self-administered through any piece of durable medical equipment. In such cases, the pharmacy must bill Medicare Part B as primary coverage and then Health First Colorado as secondary.

Any PAD dispensed "incident to" a physician service cannot be billed by a pharmacy. The drug must be purchased by the physician's office or clinic and billed through the standard buy and bill process. Guidelines for how PADs are to be billed have been established in 10 CCR 2505-10, Section 8.800.5.

Processes known as "white-bagging" and "brown-bagging" where PADs are billed to the Pharmacy Benefit and administered in the office or clinic are not usually allowed. "White-bagging" is defined as the distribution of patient-specific drug from a pharmacy to a medical provider's office, clinic or hospital for administration. "Brown-bagging" is when a pharmacy dispenses a medication directly to the member, who then transports the drug to the provider's office, clinic or hospital for administration.

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Exceptions

There may be some instances where a pharmacist can administer a PAD or specific immunizations to a Health First Colorado member in the pharmacy. 

Effective November 1, 2018, pharmacists may enroll as a provider with the Department and once enrolled can administer specific vaccinations in the pharmacy. Pharmacists must:

  • Follow the Board of Pharmacy Rules outlined in 3 CCR 719-1, 19.00.00.
  • Render vaccinations consistent with policy and the Pharmacist Vaccination list posted in the Immunization Billing Manual.
  • Bill the Medical Benefit for the vaccination procedure code and appropriate administration code.

Effective January 1, 2019, the Department implemented HB 18-1007, which stipulates that if a pharmacy has entered into a collaborative practice agreement with one or more physicians for the purposes of administering Vivitrol, that the pharmacy where the injection is administered shall receive reimbursement when an enrolled pharmacist administers the PAD in the pharmacy.

In accordance with House Bill 21-1275 and effective January 14, 2022, no place of service prior authorization is required for extended-release injectable medications (LAIs) used for the treatment of mental health or substance use disorders (SUD), when administered by a healthcare professional and billed under the Pharmacy Benefit. In addition, LAIs may be administered in any setting (pharmacy, clinic, medical office or member home) and billed to the Pharmacy or Medical Benefit as most appropriate and in accordance with all Health First Colorado billing policies.

Additional information can be found in the Pharmacist Services Billing Manual.

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Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)

Pharmacy providers dispensing any DMEPOS covered services must bill according to the DMEPOS Benefit policies and procedures outlined in the DMEPOS Billing Manual.

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Temporary Coronavirus Disease 2019 (COVID-19) Policy and Billing Information

The Department has developed the COVID-19 Information for Health First Colorado and CHP+ Providers and Case Managers web page. The Department knows providers will have many questions about COVID-19 and will post updates on policies, codes, and other important information on this site. 
Communication will continue to be sent out via bulletins and newsletters. Please sign up for updates on the Provider News web page.   

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COVID-19 Monoclonal Antibodies and Other COVID-19 Therapeutics

Beginning March 11, 2021, Health First Colorado covers COVID-19 monoclonal antibodies and other therapies without member cost sharing when used as authorized or approved by the FDA.

Health care providers may administer COVID-19 monoclonal antibodies and other therapies only in settings where they have both of the following:

Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis
The ability to activate the emergency medical system (EMS)

When doses of any COVID-19 therapy are provided without charge from the federal government, providers should bill Health First Colorado for the administration procedure codes and may bill for the monoclonal antibody or other therapy specific procedure codes on the claim. If codes are billed for the monoclonal antibodies or other therapies, the lines may pay at zero or be denied. This information is subject to change dependent on the COVID-19 public health emergency declaration. For COVID-19 monoclonal antibodies and other therapies purchased by the provider, the provider may bill the Health First Colorado Medical Benefit. Guidance will be issued in newsletters, bulletins, and emails regarding billing, coding, and reimbursement as it is made available.

Additional information regarding these therapies and EUAs can be found on the FDA Emergency Use Authorization and CMS COVID-19 Vaccines and Monoclonal Antibodies webpages.

As of January 26, 2023, there are no COVID-19 monoclonal antibody EUAs in the United States.

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Claim Submission Requirements

Claims for PADs should be submitted electronically and in accordance with timely filing requirements. All member and provider information must be included, along with a valid HCPCS/NDC combination. This policy applies to all Professional, Outpatient, Early Periodic Screening, Diagnosis and Treatment (EPSDT), and Medicare Crossover claims for PADs.

The NDC of the PAD which was administered to the member must be included with the claim. If no NDC is received or if the NDC received is invalid, the claim will be denied. Claims for all PADs must be billed with the following information.

  1. Procedure code (HCPCS)
    1. May include miscellaneous or unlisted J codes, temporary or permanent drug related Q, C, and J codes
  2. NDC of the drug administered
    1. NDC must be in an 11-digit format with no spaces, hyphens or other characters
      1. If the NDC on the PAD does not include an 11-digit NDC, provider must add zeros to maintain 5-4-2 formatting
        1. XXXX-XXXX-XX = 0XXXX-XXXX-XX = XXXXXXXXXXX
        2. XXXXX-XXX-XX = XXXXX-0XXX-XX = XXXXXXXXXXX
        3. XXXXX-XXXX-X = XXXXX-XXXX-0X = XXXXXXXXXXX
  3. HCPCS units
    1. For miscellaneous J codes, use HCPCS unit of 1
      1. J3535, J3490, J3590, J7599, J7699, J7799, J7999, J8498, J8499, J8999 or J9999
    2. For all other PADs, refer to Appendix X - HCPCS/NDC Crosswalk for appropriate HCPCS unit billing
  4. NDC units
    1. Calculate the number of units administered according to the NDC labeling
  5. NDC unit of measure qualifier
    1. Only the following are acceptable
      1. GR (gram): ointments, creams, inhalers or bulk powders
        1. This unit of measure will primarily be used in the retail pharmacy setting and not usually for physician-administered drug billing
      2. ML (milliliter): bill for liquid injectable products in vials/ampules/prefilled syringes, or for certain approved liquid non-injectable products
      3. EA (each): bill when a drug comes in a vial in powder form and must be reconstituted before administration or with certain, approved tablets, capsules or suppositories
  6. For all manually priced PADs, an invoice for the drug must be attached to the claim
    • Refer to the PAD Fee Schedule for additional information on which PADs are manually priced

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340B PAD Claim Requirements

Health First Colorado policies and procedures for Managed Care Organization and Fee-for-Service providers who participate in the 340B Drug Pricing Program are within the 340B Policy and Procedures Manual, under the Pharmacy dropdown. This guidance applies to prescription drugs dispensed in an outpatient setting (i.e., pharmacy) and drugs administered in a physician's office, clinic or hospital.

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Billing Units

Calculating NDC Units, HCPCS units, and converting HCPCS units to NDC units

  • For miscellaneous PAD codes
    • HCPCS units
      • Bill for an HCPCS unit of 1 when billing J3535, J3490, J3590, J7599, J7699, J7799, J7999, J8498, J8499, J8999 or J9999
    • NDC units
      • Example:
        Date of service 12/14/2018
        Drug and dose administered Cinvanti IV 130 MG
        Amount of drug to be billed 130 MG
        Procedure code (HCPCS) J3490
        HCPCS units 1
        NDC (11-digit format) 47426020101
        NDC description Cinvanti 130 MG/18 ML vial
        NDC units 18
        NDC unit of measure ML
        • For dates of service prior to 01/01/2019, Cinvanti is to be billed with the miscellaneous code J3490
        • HCPCS unit is billed as 1 due to the use of the miscellaneous J code for the date of service
        • The NDC unit of measure for a liquid, solution or suspension is ML, therefore, the amount billed must be in MLs
        • In this example, the quantity administered was the total amount in the vial, therefore, the quantity for NDC units is 18
          • If the dose administered is 100 mg, then the NDC units will be billed as 14 and the NDC unit of measure will remain ML
  • For permanent PAD codes
    • Example:
      Drug and dose administered Ciprofloxacin IV 1200 MG
      Amount of drug to be billed 1200 MG
      Procedure code (HCPCS) J0744
      HCPCS description Ciprofloxacin for intravenous infusion, 200 MG
      HCPCS units 6 (see explanation below)
      NDC (11-digit format) 00409476586
      NDC description Ciprofloxacin 200 MG/20 ML vial
      NDC units 120 (see explanation below)
      NDC unit of measure ML
  • Converting HCPCS units to NDC units
    • Example (from above): Drug and amount administered- Ciprofloxacin IV 1200 mg, HCPCS code- J0744, NDC description- Ciprofloxacin 200 mg/20 mL vl
      • The amount of the drug to be billed is 1200 MG, which is equal to 6 HCPCS units: (1200 MG √∑ 200 MG = 6)
      • The NDC unit of measure for a liquid, solution or suspension is ML, therefore, the amount billed must be converted from MG to ML
      • According to the NDC description for NDC 00409-4765-86, there are 200 MG of ciprofloxacin in 20 ML of solution (200 MG/20 ML)
      • Take the amount to be billed (1200 MG) divided by the number of MG in the NDC description (200 MG): 1200 √∑ 200 = 6
      • Multiply the result (6) by the number of ML in the NDC description (20 ML) to arrive at the correct number of NDC units to be billed on the claim (120): 6 x 20 ML = 120
  • Additional Examples
    Drug and dose administered Zaltrap 400 MG
    Amount of drug to be billed 400 MG
    Procedure code (HCPCS) J9400
    HCPCS description Injection, ziv-aflibercept, 1 MG
    HCPCS units 400
    NDC (11-digit format) 00024584101
    NDC description Zaltrap 200 MG/8 ML vial
    NDC units 16
    NDC unit of measure ML
    Drug and dose administered Cefepime 500 MG
    Amount of drug to be billed 500 MG
    Procedure code (HCPCS) J0692
    HCPCS description Injection, Cefepime hydrochloride, 500 MG
    HCPCS units 1
    NDC (11-digit format) 60505083404
    NDC description Cefepime HCL 1 GM vial
    NDC units 0.5
    NDC unit of measure EA
    Drug and dose administered Cefotetan 6 GM
    Amount of drug to be billed 6 GM
    Procedure code (HCPCS) J3490
    HCPCS description Unclassified Drugs
    HCPCS units 1
    NDC (11-digit format) 63323038620
    NDC description Cefotetan 2 GM vial
    NDC units 3
    NDC unit of measure EA

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Family Planning Expansion 

Effective July 1, 2022, the following changes occurred to family planning-related PADs for the Undocumented Individuals patient population (e.g. LARCs billed through the medical benefit): 

This patient population will not be subject to utilization management policies as outlined in Appendix X: HCPCS and NDC Crosswalk for Billing Physician-Administered Drugs or Appendix Y: Physician Administered Drug Medical Benefit Prior Authorization Procedures and Criteria.

Claim lines for family planning related PADs must contain the HCPCS and NDC of the PAD provided or administered to the member, in addition to all other PAD billing policies as required in this billing manual. 

For all other information as it relates to family planning benefits, please visit the Maternal, Child and Reproductive Health billing manual /web page  and the Pharmacy Billing Manual.  
 

PAD FAQs

  1. Does the drug administered by the physician and billed to Health First Colorado with an NDC have to be a "rebatable" drug?
    1. Yes. Manufacturers who wish their drug to be eligible for coverage by Health First Colorado must enter into a rebate agreement with the Centers for Medicare and Medicaid Services (CMS).
  2. How do I know if a drug is rebatable?
    1. Please refer to Appendix X - HCPCS/NDC Crosswalk.
  3. The NDC is not rebatable or I am not sure which NDC was used, can I pick another NDC under the J-Code and bill with it?
    1. No. The NDC submitted to Health First Colorado must be the actual NDC number on the package or container from which the medication was administered. It is considered a fraudulent billing practice to bill using an NDC other than the one administered.
  4. Which NDC do we use, the one from the package or the vial?
    1. The NDC is found on the drug container (i.e. vial, bottle, or tube). The NDC submitted to Health First Colorado must be the actual NDC number on the package or vial from which the medication was administered. If the vial is removed from a carton of similar vials, use the NDC on the individual bottle (inner package NDC) and not the NDC from the carton (outer package NDC). The only exception to this is if the vial is part of a kit that contains multiple products. In this case, use the NDC on the kit.
    2. The NDC submitted on the claim must be in 11-digit format. Information on converting to 11-digit formatting can be found in the PAD Billing Manual, under the CMS 1500 dropdown.
    3. If the vial is removed from a carton of similar vials, use the NDC on the individual bottle (inner package NDC) and not the NDC from the carton (outer package NDC). 
      1. The only exception is if the vial is part of a kit that contains multiple products needed for administration of the PAD. In this case, use the NDC on the kit.
         
  5. Can you confirm the NDC requirement is for outpatient claims only?
    1. Yes, this requirement applies to all drug products administered by a clinician in outpatient settings, including physician's office, clinic, hospital and any other outpatient setting. The only exceptions to the NDC requirement are institutional inpatient claims.
  6. Do radiopharmaceuticals, contrast media, devices or vaccines/immunizations require an NDC?
    1. Yes, some radiopharmaceuticals, contrast media, devices, and vaccines/immunizations may require a valid HCPCS/NDC combinations, even though they are not considered PADs. Please refer to the Appendix X - HCPCS/NDC Crosswalk for a list of these products.
  7. Who do I contact if I have questions about billing with an NDC?
    1. Refer to the Appendix X - HCPCS/NDC Crosswalk or call the Provider Services Call Center.
  8. I want to administer a PAD but cannot find the HCPCS and/or the NDC on the HCPCS/NDC Crosswalk provided by Health First Colorado. Who do I contact to request a review?
    1. Prior to administering the desired PAD, email the following information to HCPF_PAD@state.co.us
      1. HCPCS code
      2. HCPCS description
      3. NDC in 11-digit format
      4. NDC description  
    2. Should the HCPCS/NDC combination be added to the Crosswalk, it will be considered a covered benefit. 
    3. The Department may also respond to your request directly to advise of the coverage determination.  
  9. Are Medicare primary claims excluded from the NDC requirement?
    1. No. Medicare Part B Crossover claims require NDCs to be billed with the HCPCS codes.
  10. I am a 340B participating hospital. Do I need to submit NDC codes for drug claims?
    1. Yes. Although 340B purchased claims are not eligible for drug rebates, Health First Colorado requires the submission of this data.
    2. Additional billing information may be required i.e. the UD modifier. 
      1. Please refer to the 340B Billing Manual, under the Pharmacy dropdown.
  11. Can my office receive the medication from a specialty pharmacy or can the member bring the PAD to the office and I just administer the medication?
    1. No. These processes are referred to as "white-bagging" and "brown-bagging", respectively and are usually not allowed under the Health First Colorado PAD policy.
    2. Some PADs can be considered a pharmacy benefit in certain situations, but cannot be sent to the provider's office for administration.
      1. For additional information, please refer to the Pharmacy Resources web page and the most current version of Appendix P.
  12. I did not use the full quantity of drug within the vial. Can I get reimbursed for the amount of drug wasted? 
    1. No. The Department does not pay for wasted drug from single or multi-use vials, a provider must bill only for the amount of drug administered to the member.
      1. For members having both Health First Colorado and Medicare (dual-eligible), a provider may bill for wasted drug on a second line with the JW modifier on Medicare Part B Crossover claims
  13. Where can I access additional PAD specific information?
    1. The Department has made available the PAD resources page, which includes frequently asked questions, prior authorization information, and links to additional resources.
      1. Provider Services Call Center
  14. I have questions about prior authorizations or need help submitting a request, who should I contact?
    1. Contact the UM Customer Service Line for assistance with or questions regarding all PAD prior authorizations. 
      1. Kepro: 720-689-6340
  15. Where can I access additional PAD specific information?
    1. The Department has made available the PAD Resources webpage, which includes frequently asked questions, prior authorization information, and links to additional resources.
  16. How can I be kept up to date with guidance and communication from the Department?
    1. Communication is provided by the Department on a regular basis via the Provider News webpage, newsletters, emails, and monthly bulletins; therefore, providers are strongly encouraged to sign up for general and specific communication to ensure they stay up-to-date on all issued guidance and receive all communication from the Department. 

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PAD Revisions Log

Revision Date Additions/Changes Made by
5/4/2020 Manual created HCPF
5/8/2020 Converted to HTML HCPF
6/1/2020 PAD resource page link and FAQs # 13 added. HCPF
8/03/2020 Table of contents, New Drugs, and Wasted Drug updated, Retention of Records, Acceptable Use, and Exclusions added, Pharmacy Billing Requirement-Exceptions section updated, EAPG carve-out changed to Outpatient Hospital Specialty Drug carve-out, FAQ #4 updated. HCPF
8/12/2020 Inpatient/Outpatient Billing Manual added, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Billing Manual added, HCPF_Colorado.SMAC@state.co.us updated. HCPF
8/21/2020 Updated email address HCPF
9/16/2021 Updated email address to HCPF_PAD@state.co.us HCPF
01/18/2022 Updated the Table of Contents, HCPCS/NDC Crosswalk and Exclusions sections, Payment Methodology section, Pharmacy Billing Requirements and Exceptions sections, PAD Prior Authorization Requirements section, and added 340B section and Temporary COVID-19 Policy and Billing Information. Updated FAQs #2, 4, 8, 10, 11, and #13; added #12, 14, and 16. HCPF
06/21/2022 Updated the Table of Contents, HCPCS/NDC Crosswalk addition requests added to HCPCS/NDC Crosswalk section, and Family Planning Expansion added to Claim Submission Requirements section. HCPF
9/1/2022 Updated the Table of Contents, added PAD PA additional information (OP specialty drug policy, units requested on the PA, retroactive PARs, and PA submission), added Coordination of Benefits section, added section title Other Methodologies under Payment Methodologies section, added DMEPOS section under Pharmacy Billing Requirements.     HCPF
10/14/2022 Removed Phone Number References and changed Gainwell Technologies mentions to a hyperlink of Provider Services Call Center HCPF
2/23/2023 Added No COVID-19 monoclonal antibody EUAs in the United States and minor edits HCPF
4/11/2023 Updated URLs HCPF

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