Statewide Formulary for Opioid Dependence Agents and Opioid Antagonists

10/1/2021 New information highlighted below

• Guidance is also available in Portable Document Format (PDF)

Effective October 1, 2021, per the enacted New York State Executive Budget for State Fiscal Year 2020-2021 and in accordance to § 367-a (7) (e) of Social Services Law, the Department of Health (DOH) is implementing a single statewide formulary for Opioid Antagonists and Opioid Dependence Agents for Medicaid Managed Care Plans and Medicaid Fee for Service (FFS).

Under this statewide formulary (listed below), Medicaid FFS and Medicaid Managed Care (MC) will:

• follow a single formulary, where coverage parameters are consistent across the Medicaid Program, preferred products are available without prior authorization (PA) when prescribed consistent with FDA package labeling and non-preferred products require PA; and,
• use standard clinical criteria for approval of a non-preferred drug in accordance § 273 (3) (a) of Public Health Law.

Single Statewide Formulary - Effective 10/1/2021

Opioid Antagonists*

Preferred	Non-Preferred	Coverage Parameters
naloxone (syringe, vial) naltrexone Narcan (nasal spray)	None	N/A

Opioid Dependence Agents - Injectable*

Preferred	Non-Preferred	Coverage Parameters
Sublocade Vivitrol	None	N/A

Opioid Dependence Agents - Oral/Transmucosal*

Preferred	Non-Preferred	Coverage Parameters
buprenorphine Suboxone** buprenorphine/naloxone tablet	Bunavail buprenorphine/naloxone film Zubsolv	CLINICAL CRITERIA (CC): PA required for initiation of opioid therapy for patients on established opioid dependence therapy. QUANTITY LIMIT (QL): buprenorphine sublingual (SL): Six tablets dispensed as a 2-day supply; not to exceed 24 mg per day buprenorphine/ naloxone tablet and film (Bunavail™, Suboxone®, Zubsolv® up to 5.7 mg/1.4 mg strength): Three sublingual tablets or films per day; maximum of 90 tablets or films dispensed as a 30-day supply; not to exceed 24 mg-6 mg of Suboxone, or its equivalent per day buprenorphine/naloxone tablet (Zubsolv® 8.6 mg/2.1 mg strength): Maximum of 60 tablets dispensed as a 30-day supply buprenorphine/naloxone tablet (Zubsolv® 11.4 mg/2.9 mg strength): Maximum of 30 tablets dispensed as a 30-day supply

*All agents are subject to FDA approved quantity/frequency/duration limits.
** A new prescription is not required when a member is switching from the generic product to the brand product, consistent with the Medicaid FFS Brand Less Than Generic Program (BLTG). The prescription will have a generic copayment and does not require ‘Dispense as Written’ (DAW) or ‘Brand Medically Necessary’ on the prescription. This applies to Suboxone only.

Medicaid Managed Care Billing:

• MC members will continue to access these medications by presenting their plan card to the pharmacy.
• PA is required for all non-preferred agents. Providers should contact the MC plan to obtain authorization when necessary. Contact and billing information may be found here.
• Managed Care Plans will message pharmacy providers about utilizing the brand product Suboxone instead of the generic alternative, consistent with FFS
  • Managed Care Plans will provide guidance on DAW Code requirements
  • Managed Care Plans will reimburse claims consistent with brand drug reimbursement for Suboxone
  • If a pharmacy is out of stock of brand name Suboxone and the member needs the medication, the pharmacist should contact the MC plan for a one-time override to allow for the generic equivalent to be dispensed until the brand is restocked.

FFS Billing:

• FFS members will continue to access these medications by presenting their Medicaid benefit card to the pharmacy.
• PA is required for all non-preferred agents. Providers should contact Magellan plan to obtain authorization when necessary. Contact and billing information may be found here: https://newyork.fhsc.com/
• Pursuant to the Brand Less Than Generic (BLTG) program prescription claims submitted to the Medicaid program:
  • Message pharmacy providers about utilizing the brand product Suboxone instead of the generic alternative
  • Reimburses claims consistent with FFS approved drug reimbursement for brand name drugs

Pharmacies will receive the following National Council for Prescription Drug Programs Implementation (NCPDP) messages for the Product/Service ID, field 407-D7, when a generic NDC is submitted:

Code Type	Code	Message	Field	Resources
NCPDP Reject Code	78*	Cost Exceeds Maximum	FIELD 511-FB REJECT CODE	NCPDP Companion Guide
NCPDP Response Code/Message	421**	Dispense Brand Drug Instead of Generic Equivalent	FIELD 526-FQ ADDITIONAL MESSAGE INFORMATION: Insert MEVS Response Code	eMedNY ProDUR Manual

* NYS DOH is exploring the use of the updated NCPDP Reject Code 606: ‘Brand drug/specific labeler code required’. NYS DOH will provide updated billing guidance if/when use of that NCPDP Reject Code becomes available in FFS.
** Medicaid Eligibility Verification System (MEVS) Response Code, see eMedNY ProDUR Manual

Do not require the submission of Dispense as Written (DAW)/Product Selection Code of "1quot;, but does require submission DAW Code of ‘9’ in field 408-D8:

Code Type	Code	Code Description	Field
DAW Code	9	Substitution allowed by Prescriber – Plan Request Brand	408-D8

Pharmacies will receive the following NCPDP message when the appropriate DAW code is not submitted in field 408-D8:

Code Type	Code	Message	Field
NCPDP Reject Code	22	M/I Dispense as Written Code	408-D8

Questions and Additional Resources

• Single Statewide Medication Assisted Treatment (MAT) Formulary website can be found here.
• MC billing and/or PA requirement questions should be referred to the following website.
• FFS billing questions should be directed to General Dynamics Information Technology Company (GDIT) at (800) 343-9000.
• FFS PA requirement questions should be directed to Magellan at (877) 309-9493.
• FFS policy questions should be directed to the Medicaid Pharmacy Policy unit at ppno@health.ny.gov.
• FFS Brand Less Than Generic (BLTG) Program information can be found here.