Physician-Administered Drugs (PAD) Billing Manual

• Physician-Administered Drug Requirements and Benefit
• 1990 Omnibus Budget Reconciliation Act (OBRA) Rebate Program
• Timely Filing
• Record Keeping and Retention
• HCPCS/NDC Crosswalk
  • New Drugs
  • Acceptable Use
  • Exclusions
• Early and Periodic Screening, Diagnostic and Treatment (EPSDT)
• PAD Prior Authorization Information
  • Units Requested on the PA
  • Retroactive PARs
  • PA Submission 
  • 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
    • Other TPL
  • Hospital Specialty Drug Policy
• Payment Methodology
  • Other Methodologies
  • Wasted Drug
• Duplicate Reimbursement Payments
• Pharmacy Billing Requirements
  • Exceptions
  • Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) 
• Opioid Treatment Providers: Take-Home Buprenorphine
  • Medical Benefit Billing
  • Pharmacy Benefit Billing
• Temporary Coronavirus Disease 2019 (COVID-19) Policy and Billing Information
  • COVID-19 Monoclonal Antibodies and Other COVID-19 Therapeutics
• Claim Submission Requirements
  • 340B PAD Claim Requirements
  • Billing Units
  • Family Planning Expansion
• PAD FAQs
• PAD Revision Log

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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 (Colorado's Medicaid program). PAD claims are billed to and paid by the Department's fiscal agent. Refer to the Health First Colorado General Provider Information Manual for additional information on billing PADs and requirements.

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1990 Omnibus Budget Reconciliation Act (OBRA) Rebate Program

Federal regulation requires that drug manufacturers sign a national rebate agreement with the Centers for Medicare & Medicaid 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 located on the Billing Manuals web page under the General Provider Information drop-down menu.

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Record Keeping and Retention

Providers who administer and/or dispense Physician-Administered Drugs (PADs) are required by the Provider Participation Agreement with the Health First Colorado program and Colorado State Rule 8.130.2 (Program Rules and Regulations) to maintain records necessary to disclose the nature and extent of services provided to members.

Providers must maintain records that fully disclose the nature and extent of services provided. Upon request, providers must furnish information about payments claimed for Health First Colorado services. Records must substantiate submitted claim information. Such records include but are not limited to:

• Billing information
• Treatment plans
• Prior authorization requests
• Medical records and service reports, and orders prescribing treatment plans
• Records and original invoices for items, including drugs that are prescribed, ordered or furnished
• Claims, billings and records of Health First Colorado payments and amounts received from other payers

Records of providers shall include employment records, including but not limited to shift schedules, payroll records and time- cards of employees.

Providers who issue prescriptions shall keep in the patient's record, the date of each prescription and the name, strength and quantity of the item prescribed.

Each provider shall retain any other records created in the regular operation of business that relate to the type and extent of goods and/or services provided (for example, superbills). All records must be legible, verifiable and must comply with generally accepted accounting principles, auditing standards and all applicable state and federal laws, rules and regulations. 

Each medical record entry must be signed and dated by the person ordering and providing the service. Computerized signatures and dates may be applied if the electronic record-keeping system meets Health First Colorado security requirements.

These records must fully substantiate or verify claims submitted for payment and must be furnished on request to the authorizing agency. Records must be retained for at least seven (7) years or longer if required by regulation or a specific contract between the provider and the Health First Colorado program.

At the request of the US Department of Health and Human Services (HHS), the Department, the Colorado Department of Human Services, or the Medicaid Fraud Control Unit (MFCU), and at the request of any of their authorized designees, record verification may include, but will not be limited to, interviews with providers, employees of providers, billing services that bill on behalf of providers, and any member of a corporate structure that includes the provider as a member.

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HCPCS/NDC Crosswalk

An updated Healthcare Common Procedure Coding System (HCPCS)/ National Drug Code number (NDC) Crosswalk is published twice per month to provide billing guidance on PADs and posted under Appendix X: HCPCS / NDC Crosswalk for Billing Physician-Administered Drugs. Appendix X is generally updated on the first and 15th of each month excluding holidays and weekends, when it is updated on the subsequent business day. The Crosswalk is utilized to process PAD claims in the Department’s Medicaid Management Information System (MMIS). 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. Refer to the Pharmaceutical Benefit Help Guide located on the PAD web page for appropriate benefit billing guidance.

For inquiries of HCPCS/NDC combinations to potentially be added to the Crosswalk, 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 three 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: The claim line will be denied if a PAD claim is billed without a valid HCPCS/NDC combination listed on Appendix X or the HCPCS/NDC billed on a PAD claim is determined not to be a covered benefit. 

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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. Refer to the Payment Methodology section of this manual.
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 Information’). 

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.

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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 HHS 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. Refer to the Pharmacy Billing Requirements section below and the Pharmacist Services Billing Manual.

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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 located on the Billing Manuals web page under the General Provider Information drop-down menu.

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PAD Prior Authorization Information

Effective January 18, 2022, a select number of PADs are subject to prior authorization (PA) requirements. Visit the PAD web page for all PAD PA policies and procedures.
 
Providers must: 

• Submit a PA Request (PAR) 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, located on the PAD web page. 
• 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 web page.

Approval of a PAR does not guarantee Health First Colorado payment. 

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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.

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Retroactive PARs

Retroactive authorizations are not usually 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 and applicable documentation of the circumstance that was beyond the control of the provider in the request for retroactive authorization. 

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.

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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. 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, the following steps must be completed 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.

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Other TPL 

Providers must submit a PAR to Acentra for any PAD listed on Appendix Y when a member has additional TPL health insurance coverage, other than Medicare. Acentra 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 Acentra, 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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Hospital Specialty Drug Policy

PADs associated with the Hospital Specialty Drug policy require approval of a member-specific prior authorization prior to administration. Refer to Appendix Z: List of Outpatient Hospital Specialty Drugs or visit the PAD web page for coverage standards, policies and procedures. Refer to the Inpatient/Outpatient (IP/OP) Billing Manual for additional information.

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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. MP 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.

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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. Refer to the Inpatient/Outpatient (IP/OP) Billing Manual for additional information.

Certain PADs administered in the hospital setting may be subject to reimbursement outside of the methodologies outlined above and require prior authorization. Refer to the Inpatient/Outpatient (IP/OP) Billing Manual and Appendix Z for an updated list.

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

Health First Colorado-only members: The Department does not pay for wasted drug from single or multi-use vials. Providers must bill only for the amount of drug administered to the member.

Dually eligible members (members having both Medicare and Health First Colorado): 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. Effective January 1, 2023, CMS issued guidance for billing of the JZ modifier for zero drug wasted. At this time, the Department will accept billing of the JZ modifier as informational only on Crossover claims.

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Duplicate Reimbursement Payments

Effective January 14, 2022, the Department’s MMIS will compare fee-for-service pharmacy and professional/professional crossover claim types to prevent duplicate reimbursement payments for PADs. An office/clinic will not be reimbursed for a PAD when another pharmacy or professional/professional crossover claim line has been paid for the same PAD NDC range within seven days of the date of service.

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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. Visit 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 (PT) 09 with Durable Medical Equipment (DME) Provider Specialty (PS) 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 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 Immunizations 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.

Refer to the Pharmacist Services Billing Manual for additional information.

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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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Opioid Treatment Providers: Take-Home Buprenorphine

Effective May 1, 2023, opioid treatment providers (OTPs) may dispense up to a seven-day supply of take-home oral buprenorphine and buprenorphine combination products.

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Medical Benefit Billing

The take-home supply of up to seven (7) days may be billed as a PAD through the medical benefit via standard buy-and-bill processes when an OTP:

• Obtains the appropriate Drug Enforcement Administration (DEA) registration
• Has authority based on the rules and regulations set forth by the State of Colorado
• Follows all guidelines set forth by the Substance Abuse and Mental Health Services Administration (SAMHSA)

OTPs must be enrolled with Health First Colorado as PT 64: Substance Use Disorder – Clinic and bill for the HCPCS/NDC of the buprenorphine or buprenorphine combination product dispensed to the member.  

In-office: The OTP must bill for the office-administered oral buprenorphine or buprenorphine combination PADs, along with any additional procedure codes as applicable, for the date of service when the PAD was administered and observed in office. 

Example:

Take-home: a separate line must be used for the amount dispensed as a take-home supply. The From Date of Service (FDOS) and To Date of Service (TDOS) should start the day after the clinic visit and represent the total number of days appropriate for the amount dispensed. The date span shall be no more than seven days in total and place of service must be home (POS 12).    

Example:

If the HCPCS and NDC billed on both lines is the same and either line denies for duplicate, OTPs may bill modifier 76, in addition to any other applicable modifiers.

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Pharmacy Benefit Billing

Some oral buprenorphine products may be preferred or subject to prior authorization requirements when billed and dispensed through the pharmacy benefit. Refer to the Preferred Drug List (PDL) and Appendix P located on the Pharmacy Resources web page for all pharmacy benefit policies and procedures on continuation of care and allowing for transition from take-home supply to outpatient prescription.

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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. 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.

Healthcare 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 web page.

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 total amount of a PAD administered to a member should be billed on one claim line, unless the total amount was obtained from vials/kits containing different NDCs. If the total amount of a PAD administered was used from vials/kits with different NDCs, providers may bill the PAD on two lines, each with the respective HCPCS/NDC combination and units used from each. 

The NDC of the PAD which was administered to the member must be included with the claim. If no NDC is received, the NDC billed is invalid, or the HCPCS/NDC combination is not on the Crosswalk, the claim will be denied. Claims for all PADs must be billed with the following information.

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

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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, located on the Billing Manuals web page under the Pharmacy drop-down. 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 (refer to explanation below)
    NDC (11-digit format)	00409476586
    NDC description	Ciprofloxacin 200 MG/20 ML vial
    NDC units	120 (refer to 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 UM 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. 

Refer to the Obstetrical Care Billing Manual and the Pharmacy Billing Manual for all other information as it relates to family planning benefits.

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PAD FAQs

• Does the drug administered by the physician and billed to Health First Colorado with an NDC have to be a "rebatable" drug?
  • 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 & Medicaid Services (CMS).
• How do I know if a drug is rebatable?
  • Refer to Appendix X: HCPCS / NDC Crosswalk for Billing PAD.
• 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?
  • 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.
• Which NDC do we use - the one from the package or the vial?
  • 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.
  • The NDC submitted on the claim must be in 11-digit format. Information on converting to 11-digit formatting can be found in the Claim Submission Requirements section of this manual.
  • 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 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.
• Can you confirm the NDC requirement is for outpatient claims only?
  • 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.
• Do radiopharmaceuticals, contrast media, devices or vaccines/immunizations require an NDC?
  • Yes, some radiopharmaceuticals, contrast media, devices, and vaccines/immunizations may require a valid HCPCS/NDC combinations, even though they are not considered PADs. Refer to Appendix X: HCPCS / NDC Crosswalk for Billing PAD for a list of these products.
• Who do I contact if I have questions about billing with an NDC?
  • Refer to Appendix X: HCPCS / NDC Crosswalk for Billing PAD or contact the Provider Services Call Center.
• 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?
  • Prior to administering the desired PAD, email the following information to HCPF_PAD@state.co.us
    • HCPCS code
    • HCPCS description
    • NDC in 11-digit format
    • NDC description  
  • Should the HCPCS/NDC combination be added to the Crosswalk, it will be considered a covered benefit.
• Are Medicare primary claims excluded from the NDC requirement?
  • No. Medicare Part B Crossover claims require NDCs to be billed with the HCPCS codes.
• I am a 340B-covered entity. Do I need to submit NDC codes for drug claims?
  • Yes. Although 340B purchased claims are not eligible for drug rebates, Health First Colorado requires the submission of this data.
  • Additional billing information may be required (i.e., the UD modifier). 
    • Refer to the 340B Policy and Procedures Manual located on the Billing Manuals web page under the Pharmacy drop-down.
• 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?
  • 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.
  • Some PADs can be considered a pharmacy benefit in certain situations but cannot be sent to the provider's office for administration.
    • Refer to the Pharmacy Resources web page and the most current version of Appendix P for additional information.
• I did not use the full quantity of drug within the vial. Can I get reimbursed for the amount of drug wasted? 
  • No. The Department does not pay for wasted drug from single or multi-use vials. Providers must bill only for the amount of drug administered to the member.
    • For members having both Health First Colorado and Medicare (dual-eligible), providers may bill for wasted drug on a second line with the JW modifier on Medicare Part B Crossover claims.
• Where can I access additional PAD-specific information?
  • Visit the PAD web page, which includes frequently asked questions, prior authorization information, and links to additional resources.
  • Contact the Provider Services Call Center.
• I have questions about prior authorizations or need help submitting a request, who should I contact?
  • Contact the UM Customer Service Line for assistance with or questions regarding all PAD prior authorizations. 
    • Acentra: 720-689-6340
• How can I be kept up to date with guidance and communication from the Department?
  • Communication is provided by the Department on a regular basis via the Provider News web page, 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

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