Policies and Billing Guidance for Practitioner Administered Drugs
This page contains policies and billing guidance for practitioner administered drugs (PADs). Clinical criteria for certain drugs and drug classes can be found below.
Medicaid Fee-For-Service Policy for PADs
New York State Medicaid fee-for-service (FFS) program policies and billing guidance for practitioner administered drugs (PADs) are available at:
- Provider Manuals
- Medicine, Drugs and Drug Administration (See section: DRUGS ADMINISTERED OTHER THAN ORAL METHOD)
Additionally, coverage updates may be published in the Medicaid Update, which is published monthly. The Medicaid Update Main Page has topics arranged alphabetically and contains search functionality. Specific Medicaid Update articles about PADs are also in the resources section below. Periodically, communications are posted on the eMedNY website . Important information for each practitioner group can be found under Provider Manuals . Within many practitioner groups, the right-hand panel will have a "Featured Links" section that contains a link to that group's communications.
Clinical Criteria
The Medicaid Drug Utilization Review (DUR) program, inclusive of the DUR Board, helps to ensure that pharmaceutical therapy is appropriate, medically necessary, and not likely to result in adverse medical consequences. Clinical criteria have been developed to ensure appropriate utilization of PADs.
PAD Search Tool
The PAD Search Tool provides a list of practitioner administered drugs that can be billed to the medical benefit using a Healthcare Common Procedure Coding System (HCPCS) code and National Drug Code (NDC). If a drug is not included in this tool and is considered a Medicaid covered drug, the practitioner may submit a letter of medical necessity and supporting documentation (recent chart notes) by a secure email system to NYRx@health.ny.gov
Prior Authorization
Beginning November 19, 2026, Medicaid FFS will require prior authorizations for select drugs administered in office, clinic, or outpatient settings. Prescribers will be required to obtain prior authorization (PA) before Medicaid will cover the cost of the drug. The Practitioner Administered Drug Program is changing from the "by report" manual pended claims process to a streamlined PA framework. The program utilizes a sophisticated clinical editing system that leverages pharmacy and medical claim data (from both Medicaid FFS and Medicaid Managed Care) to automatically approve claims that meet PA criteria. If the corresponding diagnosis, drug, or procedure code is already present in the member's claim history, an approved PA can be generated without prescriber involvement.
- The prior authorization process will initially apply to select drugs and drug classes for dates of service on or after November 19, 2026. Check the PAD Quick Reference Guide for the list of drugs and drug classes.
- Providers must submit the total quantity of NDC units when requesting PA.
- The clinical criteria table (below) provides worksheets for PAD claims that still require manual review.
- Sign up for the eMedNY LISTSERV® and NYRx Education & Outreach Notification Service to receive the latest updates about FFS policy and guidance for PADs.
Verify if Prior Authorization is Required
Practitioners should check the clinical criteria (see table below) for drugs and drug classes that require prior authorization. Alternatively, a real-time claim can be submitted through ePACES to check if a PAD requires prior authorization. If a claim is rejected with edit ID 00186 "Procedure Requires PA," then the practitioner must obtain prior authorization. Providers must ensure an approved PA is obtained prior to drug administration
How to Obtain Prior Authorization
Practitioners can obtain a PA through any of the following options:
- Electronic (preferred method)
- PAXpress – Use the same username and password as your ePACES account.
- CoverMyMeds – Check their quick guide about how to create an account and request PA.
- Fax the prior authorization form to 1-800-268-2990.
- Call the NYRx Clinical Call Center at Prime Therapeutics at 1-877-309-9493, open 24 hours daily.
For support with obtaining a PA, contact the NYRx Education & Outreach (E&O) Team at 1-833-967-7310 or NYRxEO@primetherapeutics.com. Additional information and resources will be available on the Practitioner Administered Drug Program page .
Worksheets for PADs that Require Manual Review (Paper Claim)
Select practitioner administered drugs, such as cell and gene therapy, will still require manual review via paper claim submission. The following table includes Practitioner Administered Drug Clinical Criteria Worksheets for certain drugs and drug classes that must be submitted with the paper claim along with the invoice copy. More information about claim submission requirements are in the Billing Guidance section of this website. If a drug/drug class does not have a specific worksheet, then submit the Standard Clinical Criteria Worksheet with the claim.The Standard Clinical Criteria Worksheet can be submitted if:
- a specific worksheet is not available for the drug,
- the drug has been recently approved by the Food and Drug Administration, or
- the drug has not been assigned a specific Healthcare Common Procedure Coding System (HCPCS) code (i.e., "unclassified").
The clinical criteria table (PDF) is also available in portable document format.
| Drug / Drug Class | Clinical Criteria / Coverage Parameters | Clinical Criteria Worksheets for the Fee-for-Service (FFS) Program |
|---|---|---|
| Botulinum Toxin Agents onabotulinumtoxinA(Botox®) abobotulinumtoxinA(Dysport®) rimabotulinumtoxinB(Myobloc®) incobotulinumtoxinA(Xeomin®) DaxibotulinumtoxinA(Daxxify ®) |
Confirm diagnosis of Food and Drug Administration (FDA)-approved or compendia supported indication and Medicaid covered indication.Trial of glycopyrrolate for chronic sialorrhea (excludes patients with Parkinson's disease and other neurogenerative diseases).Trial of antimuscarinic agent or beta-3-adrenoceptor agonist for overactive bladder. | Effective November 19, 2026: No worksheet or manual review required for the claim. Prior authorization may be required. Worksheet(s) for service dates before November 19, 2026: |
| betibelogene autotemcel (Zynteglo®) ^* | Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. For members with a diagnosis of transfusion-dependent beta-thalassemia: the patient is a candidate for allogenic hematopoietic cell transplantation, but ineligible due to the absence of a donor; and the patient is less than or equal to (≤) fifty years of age. If the patient is less than (<) five years of age, the patient weight must be greater than or equal to (≥) six kilograms. Confirmation of FDA-approved or compendia supported indication and Medicaid covered indication. |
Zynteglo® (PDF) |
| Duchenne Muscular Dystrophy (DMD) casimersen (Amondys 45®) eteplirsen (Exondys 51®) viltolarsen (Viltepso®) golodirsen (Vyondys 53®) |
Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication: documentation of genetic testing must confirm the DMD gene mutation of the patient is amenable to exon 45, 51, or 53 skipping; documentation must confirm a stable dose of corticosteroids prior to starting therapy or a documented reason not to be on corticosteroids; documentation indicates kidney function testing prior to starting therapy (except for eteplirsen); and patient is not concurrently being treated with another exon skipping therapy for DMD. |
Effective November 19, 2026: No worksheet or manual review required for the claim. Prior authorization may be required. Worksheet(s) for service dates before November 19, 2026: Duchenne Muscular Dystrophy (PDF) |
| delandistrogene moxeparvovec-rokl (Elevidys®) | In accordance with FDA product safety labeling requirements.
|
Elevidys® (PDF) |
| elivaldogene autotemecel (Skysona®) | Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. The patient is a candidate for hematopoietic stem cell transplant (HSCT), but ineligible due to the absence of a donor. The patient does not have human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV). The patient is not utilizing anti-retroviral drugs at least one month prior to initiating medications for stem cell mobilization and until all cycles of apheresis are completed. |
Skysona® (PDF) |
| esketamine nasal spray (Spravato®) | Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. Before initiating Spravato® (esketamine) nasal spray, prescribers must attest that they have obtained a baseline score using a validated clinical assessment tool for depression [e.g., Hamilton Depression Rating Scale (HAMD-17), Quick Inventory of Depressive Symptomatology (QIDS-C16C), Montgomery-Asberg Depression Rating Scale (MADRS)]. Trial of at least two oral antidepressants prior to Spravato® (esketamine) nasal spray when used for Treatment Resistant Depression. After the initiation of Spravato® (esketamine) nasal spray therapy, every six months prescribers must attest that Spravato® (esketamine) nasal spray has resulted in an improvement of depressive symptoms (from baseline) using the same baseline clinical assessment tool for depression [e.g., Hamilton Depression Rating Scale (HAMD-17), Quick Inventory of Depressive Symptomatology (QIDS-C16C), Montgomery-Asberg Depression Rating Scale (MADRS)]. |
Effective November 19, 2026: No worksheet or manual review required for the claim. Prior authorization may be required. Worksheet(s) for service dates before November 19, 2026: Spravato® (PDF) |
| etranacogene dezaparvovec-drlb (Hemgenix®) | Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. The patient must have a confirmation of moderately severe to severe, congenital hemophilia B. The patient does not have a history of factor IX inhibitors. The patient does not have a positive factor IX inhibitor test. |
Hemgenix® (PDF) |
| Infliximab Agents Infliximab (Remicade®) infliximab-abda (Renflexis®) infliximab-axxq (Avsola®) infliximab-dyyb (Inflectra®) infliximab-dyyb (Zymfentra®) 120mg/ml pen/syringe |
Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. A trial of a conventional agent, disease-modifying anti-rheumatic drug (DMARD) or tumor necrosis factor inhibitor (TNFi)*, Food and Drug Administration (FDA)-approved for self-administration prior to initiation of infliximab, in accordance with FDA package labeling or compendia-supported use. *Step Therapy does not apply to Ulcerative Colitis and Chrohn's disease. |
Effective November 19, 2026: No worksheet or manual review required for the claim. Prior authorization may be required. Worksheet(s) for service dates before November 19, 2026: Infliximab (PDF) |
| nusinersen (Spinraza®) | Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication The patient must not have advanced disease (e.g., complete limb paralysis or permanent ventilator dependence) |
Effective November 19, 2026: No worksheet or manual review required for the claim. Prior authorization may be required. Worksheet(s) for service dates before November 19, 2026: Spinraza® (PDF) |
| onasemenogene aberparvovec-xioi (Zolgensma®) | In accordance with FDA indications, FFS will reimburse Zolgensma® for one treatment per person for their lifetime when the following criteria are met: The patient must have a confirmed diagnosis of SMA with bi-allelic mutations in the SMN1 gene; The patient must be less than two (2) years of age; For neonatal patients born prematurely, full-term corrected gestational age (40 weeks) must be reached The patient must have a baseline anti-AAV9 antibody titer of ≤ 1:50 prior to administration; and The patient must not have advanced disease (i.e., complete limb paralysis, permanent ventilation dependence). Note: Permanent ventilator dependence is defined as requiring invasive ventilation (tracheostomy) or respiratory assistance for 16 or more hours per day (including noninvasive ventilator support) continuously for 14 or more days in the absence of an acute reversible event, excluding perioperative ventilation. |
Zolgensma® (PDF) |
| Viscosupplementation | Have a diagnosis of either: Arthropathy - disorder of shoulder, or Subacromial impingement, syndrome of the shoulder |
Viscosupplementation (PDF) |
| Sickle Cell Disease exagamglogene autotemcel (Casgevy®)^* lovotibeglogene autotemcel (Lyfgenia®)^* |
Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. | N/A |
Billing Guidance
With the implementation of prior authorization for certain PADs, the billing process has been updated:
- Verify if prior authorization (PA) is required before servicing the member.
- After obtaining PA and servicing the member, submit an electronic claim (recommended method) or paper claim to eMedNY.
- If the claim is denied, check the PAD Top Edit Resource for information about how to resolve it.
Electronic Claim Submission
Providers may submit professional claims electronically via ePACES or other methods accepted by eMedNY. For help with claims and ePACES, check the ePACES Professional Real Time Claim Reference Guide and training videos , or contact the eMedNY Call Center at 1-800-343-9000.
Paper Claim Submission for Codes Listed "By Report"
There are certain drugs listed as "By Report (BR)" on the Physician Manual Fee Schedule and Ordered Ambulatory Fee Schedule, such as cell and gene therapies. Providers will continue to submit paper claims for these drugs, including the Clinical Criteria Worksheet where applicable, using the Medical Assistance Health Insurance Claim Form New York State eMedNY-150003 with the following:
- Healthcare Common Procedure Coding System (HCPCS) code for the drug
- The associated National Drug Code (NDC)
- A copy of the invoice dated within six months prior to the date of service and/or should include the expiration date of the drug
Check the New York State Medicaid General Professional Billing Guidelines for claim submission guidance, including the address for submitting a claim form. For billing questions, please contact the eMedNY Call Center at 1-800-343-9000.
- Claim processing may be delayed if the information submitted in the worksheet is illegible.
- If the worksheet is left blank or information is missing, the claim will be rejected for not enough documentation and reimbursement will be delayed.
- A claim should not be submitted until the drug has been administered to the patient.
- The manufacturer invoice showing the acquisition cost of the drug administered, including all discounts, rebates, and incentives must be submitted with the claim. The invoice must be dated within 6 months prior to the date of service and/or should include the expiration date of the drug, or it will be rejected for not enough documentation.
Maximum Reimbursement Amount
The NYS Medicaid program will reimburse for drugs furnished by practitioners to their patients using the benchmarks listed in Table 1 of the March 2026 Special Edition Medicaid Update. The Maximum Reimbursable Amount (MRA) for drugs billed via Professional claim types will be determined by the National Drug Code (NDC) reported on the claim instead of the Healthcare Common Procedure Coding System (HCPCS) code. Providers are required to report the NDC for all PADs billed by a private practitioner to NYS Medicaid and for all ordered ambulatory claims billed by clinics. For all drugs furnished in this fashion, it is expected that the practitioner will maintain auditable records of the actual itemized invoice cost of the drug, including the numbers of doses of the drug represented on the invoice. If the NDC is not referenced on a claim, NYS Medicaid will not provide reimbursement for the drug. Please note: Both the HCPCS units and NDC quantity must be reported separately and must reflect their respective dosage forms.
Medicaid Managed Care
Most members enrolled in New York State Medicaid are covered under Medicaid Managed Care (MMC). Their medical benefits, including practitioner administered drugs, are covered under their specific MMC plan. The MMC information page provides links to each plan's policy and billing guidance for PADs.For Cell and Gene Therapy drugs reimbursed by FFS, or carved out, Medicaid Managed Care plan representatives must submit this form to the Department of Health (NYRx@health.ny.gov) by a secure email system.
Resources and Support
Resources about PADs
- Practitioner Administered Drug (PAD) Program
- PAD Search Tool
- Reimbursement for Medicaid Fee-for-Service Professional Drug Claims (PDF)
- PAD Top Edit Resource for Professional Claims
- Edit/Error Knowledge Base (EEKB) Search Tool
Medicaid Updates about PADs
- Reimbursement Change for Medicaid Fee-for-Service Professional Drug Claims - March 2026
- 340B Claim Reminder for Covered Entities and Contract Pharmacies – June 2023
Important Contacts
| Support Team | Contact Information | Responsibilities |
|---|---|---|
| Office of Health Insurance Programs (OHIP) Division of Drug Policy and Rebate Management | Phone: (518) 486-3209 Email: NYRx@health.ny.gov Website: health.ny.gov/nyrx |
Medicaid policy for pharmacy and medical drugs |
| eMedNY Call Center | Phone: (800) 343-9000 Website: emedny.org |
FFS provider enrollment, billing, claims, and ePACES |
| NYRx Clinical Call Center | Phone: (877) 309-9493, Open 24 hours daily Fax: (800) 268-2990 Website: newyork.fhsc.com |
Prior authorizations for NYRx |
| NYRx Education & Outreach Team | Phone: (833) 967-7310 Email: NYRxEO@primetherapeutics.com Website: newyork.fhsc.com |
Liaison between stakeholders (such as prescribers, pharmacies, and managed care plans) and NYRx to support care coordination and provide informing materials, trainings, and timely communications regarding NYRx programs. |
Medicaid Managed Care reimbursement, billing, and/or documentation questions should be directed to the member's MMC plan.