Policies and Billing Guidance for Practitioner Administered Drugs

This page contains policies and billing guidance for practitioner administered drugs (PADs). Worksheets for certain drugs and drug classes can be found in the clinical criteria section.

New York State Medicaid fee-for-service (FFS) program policies and billing guidance for practitioner administered drugs (PADs) are available at:

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.

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.

The clinical criteria table below includes links to guidance for specific practitioner administered drugs or drug classes. Some drugs or drug classes have corresponding Practitioner Administered Drug Clinical Criteria Worksheets. The Archive has previous guidance and worksheets.

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").
Claim Submission

Providers will submit claims, 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 document 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.

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. The following table contains clinical criteria and coverage parameters for certain Practitioner Administered Drugs (PADs). For PADs not listed below, coverage is in accordance with FDA-approved or compendia supported, and Medicaid covered indications. The clinical criteria table is also available in portable document format (PDF).

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®)		 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 two oral agents FDA-approved or compendia-supported for prevention of migraine for treatment of headache prevention in patients with chronic migraine.

Trial of antimuscarinic agent or beta-3-adrenoceptor agonist for overactive bladder.		 Botox®

Dysport®

Myobloc®

Xeomin®
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®
Chimeric Antigen Receptor (CAR) T-cell Therapy Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. N/A
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.		 Duchenne Muscular Dystrophy
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®
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)].		 Spravato®
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®
goserlin implant
(Zoladex®)		 Coverage of Zoladex® will continue to be provided for Medicaid members who are unable to obtain the medication through the Patient Assistance Program (PAP) and when used under the following conditions:

for a FDA approved indication for which there are no alternative options and;

as a continuation of established therapy if another gonadotropin-releasing hormone (GnRH) product has been tried and failed or if transition to another GnRH is medically contraindicated.		 Zoladex®
Infliximab Agents infliximab (Remicade®), infliximab-abda (Renflexis®),

infliximab-axxq (Avsola®), and infliximab-dyyb (Inflectra®)

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.

vedolizumab (Entyvio®)

Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication.

A trial of a conventional agent, DMARD or TNFi, prior to initiation of vedolizumab in accordance with FDA package labeling or compendia-supported use.		 Infliximab

Entyvio®
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)		 Spinraza®
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 have three (3) copies or less of the SMN2 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®
Viscosupplementation Have a diagnosis of either:

Arthropathy - disorder of shoulder, or

Subacromial impingement, syndrome of the shoulder		 Viscosupplementation
Sickle Cell Disease

exagamglogene autotemcel
(Casgevy®)^*

lovotibeglogene autotemcel
(Lyfgenia ®)^*		 Confirm diagnosis of FDA-approved or compendia supported indication and Medicaid covered indication. N/A

^ The drug is carved out of the FFS inpatient rate.

* The drug is carved out of Managed Care. Approval for treatment related medical care will be determined by the Managed Care Plan with notification to the Department of such approval.

Medicaid Managed Care (MMC) plan policies and billing guidance for practitioner administered drugs can be found at the MMC information page. Select a plan and then the link to practitioner administered drug policy and billing guidance. 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.

  • FFS policy questions may be directed to the Office of Health Insurance Programs (OHIP) Division of Program Development and Management at 518) 486-3209.
  • FFS billing and claim questions should be directed to the eMedNY call center at (800) 343-9000.
  • MMC reimbursement, billing, and/or documentation questions should be directed to the enrollee's MMC plan.