New York State Medicaid Update - October 2025 Volume 41 - Number 10

In this issue …


Section 504 of the Rehabilitation Act of 1973 Final Rule

On July 8, 2024, the United States (U.S.) Department of Health and Human Services (HHS) published the final rule of Section 504 of the Rehabilitation Act of 1973. The rule prohibits disability-based discrimination in programs and activities that receive federal financial assistance as well as in programs and activities conducted by any federal agency. This impacts all Medicaid and Medicare providers.

Who is Protected Under Section 504?

Under Section 504, U.S. HHS defines an individual with a disability as a person who has a physical or mental impairment that substantially limits one or more life activities, has a record of such impairment, or is regarded as having such an impairment. The definition of disability is intended to be applied broadly to ensure coverage to the maximum extent permitted.

Accessible Medical Equipment

Section 504 includes new requirements to ensure that medical diagnostic equipment (MDE) is accessible to individuals with disabilities in all facilities that bill Medicaid and Medicare. These regulatory changes, located in Subpart J, include:

§84.92 Newly Purchased, Leased, or Otherwise Acquired Medical Diagnostic Equipment
All MDE acquired after September 8, 2024, must meet Standards for Accessible MDE subject to the following thresholds (scoping requirements):

  • In general, medical facilities (e.g. physician's offices, clinics, hospitals), at least 10 percent of each type of MDE in use, but not fewer than one unit, must be accessible.
  • In rehabilitation and other facilities that specialize in mobility-related care, at least 20 percent of each type of MDE in use, but not fewer than one unit, must be accessible.
  • In facilities with multiple departments, equipment must be evenly distributed across departments that use the MDE.

Minimum Requirements for Newly Acquired Medical Diagnostic Equipment (by July 8, 2026):

  • At least one accessible exam table and one accessible weight scale if such equipment is used.
  • Recipients may use alternative standards to those required by the Standards for Accessible MDE if the alternative standards result in equivalent or greater accessibility and usability.
  • The Standards for Accessible MDE provide additional details on medical diagnostic equipment features based on patient position (refer to table below).

Equipment Features Needed for Patient Support in Supine, Prone, or Side-Lying, Seated, Seated in Wheelchair or Standing Positions

Patient Positions Equipment Designed to Support Standards Examples of Types of Equipment that Apply to Patient Position
Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position
  • Transfer surface, including height, size, and transfer sides
  • Transfer supports, stirrups, and head and back support
  • Lift compatibility
  • Examination tables
  • Examination chairs designed to recline and be used as examination tables
Diagnostic Equipment Used by Patients in a Seated Position
  • Transfer surface, including height, size, and transfer sides
  • Transfer supports, armrests, and head and back support
  • Lift compatibility
  • Examination chairs
  • Imaging equipment designed for use with a seat
  • Weight scales designed for use with a seat
Seated in a wheelchair
  • Wheelchair space, including orientation, width, depth, knee and toe clearance, and surface slope
  • Changes in level at entry to wheelchair space, including ramps
  • Components capable of examining body parts of patients seated in a wheelchair, including height of breast platforms
  • Imaging equipment designed for wheelchair use.
  • Weight scales designed for wheelchair use
Standing position
  • Slip resistant standing surface
  • Standing supports
  • Imaging equipment designed for use in standing position
  • Weight scales designed for use in standing position

§84.93 Existing Medical Diagnostic Equipment:

  • Existing MDE does not need to be individually accessible, but programs must be accessible overall.
  • Recipients must use methods like service reassignment or alternate locations if necessary.
  • Exceptions are allowed for undue burden or fundamental alteration, with proper documentation.

§84.94 Qualified Staff:

  • Staff must be trained to operate accessible equipment, assist with patient transfers, and support compliance efforts.
  • A patient may choose to bring another person such as a friend, family member, or personal care aide to an appointment, but a staff member cannot require those individuals to help during an exam.
  • Staff may need to provide reasonable assistance to enable the patient to receive medical care, including helping a person who uses a wheelchair to transfer from their wheelchair to the exam table or diagnostic chair.

Questions and Additional Information:

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Attention New York State Medicaid Public Transit Automated Reimbursement Providers: MetroCard Phase-Out

The Metropolitan Transportation Authority (MTA) is phasing out the MetroCard and transitioning to Tap and Ride, a contactless fare payment system that allows customers to ride using smart devices, bank cards or One Metro New York (OMNY) cards.

This transition affects providers enrolled in the New York State (NYS) Medicaid Public Transit Automated Reimbursement (PTAR) program. MetroCards will no longer be available for public sale after December 31, 2025. MTA will ensure continuity of access to fare products for PTAR-enrolled agencies as they shift from MetroCard to OMNY card purchases.

NYS Medicaid PTAR providers should begin purchasing paper OMNY cards for distribution and reimbursement when providing MTA transportation to NYS Medicaid members attending NYS Medicaid-covered services. Additional fare products, including reloadable plastic OMNY cards, are also available through OMNY. The paper OMNY card cost of $0.18 per card will be included in NYS Medicaid PTAR reimbursement in addition to the cost of the fare.

Questions and Additional Information:

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The New York State (NYS) Department of Health (DOH) is reminding all NYS Medicaid-enrolled Health Home (HH) providers that they must accept the following NYS DOH HH consent forms, without requiring additional or alternate forms:

  • NYS DOH Health Home Patient Information Sharing Consent form (DOH 5055)
  • NYS DOH Health Home Enrollment and Information Sharing Consent For Use with Children Under 18 Years of Age form (DOH 5201)

Both the DOH 5055 and DOH 5201 forms are valid Health Insurance Portability and Accountability Act (HIPAA)-compliant consent instruments that authorize the release and sharing of Personal Health Information (PHI) among identified providers and partners. By completing and signing the consent form, the NYS Medicaid member agrees to enroll in the HH program and permits their PHI to be accessed and shared among those partners/providers approved by the NYS Medicaid member and identified within the consent form, including the Statewide Health Information Network for New York, the Psychiatric Services and Clinical Knowledge Enhancement System, the Tracking and Billing System, and the Uniform Assessment System NY. These consents allow HH care managers to effectively access, integrate and coordinate services for NYS Medicaid members.

Both the DOH 5055 and DOH 5201 forms are authorized and sufficient documents for obtaining patient consent to disclose and exchange Human Immunodeficiency Virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related information among HH care managers and participating providers, including but not limited to primary care providers, specialty care providers and managed care organizations.

By comparison, the NYS DOH Authorization for Release of Health Information and Confidential HIV-Related Information (DOH 2557), developed by the AIDS Institute, is generally used to authorize the release of confidential HIV/AIDS-related information between individual health care providers. The HH member execution of a DOH-5055 or DOH 5201 form authorizes the appropriate disclosure of HIV/AIDS-related information among entities identified on the DOH 5055 and DOH 5201 forms, making the additional completion of the DOH-2557 unnecessary.

Important Forms:

  • NYS DOH Health Home Patient Information Sharing Consent form (DOH-5055)
  • NYS DOH Health Home Consent Frequently Asked Questions (FAQ) For Use with Children Under 18 Years of Age document (FAQ for DOH-5201)
    • Please note: The FAQ for DOH 5201 must be reviewed before the DOH 5201 is completed and signed.
  • NYS DOH Health Home Enrollment and Information Sharing Consent For Use with Children Under 18 Years of Age form (DOH-5201)

NYS and Federal laws and regulations governing shared information are located at the following links:

Federal Medicaid confidentiality laws and regulations are located at the following links:

NYS Medicaid confidentiality laws and regulations are located at the following links:

Providers should refer to the Reminder: Health Home Consent Forms article published in the December 2022 issue of the Medicaid Update, for information relating to accepting HH consent forms as valid HIPAA-compliant forms.

Questions

Questions regarding this guidance should be directed to the NYS HH program at healthhomes@health.ny.gov, with the subject line, "Health Home Policy".

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Updated Implementation Date: Ambulatory Patient Group Weight Adjustment for Phosphate Binders

This communication provides an important update regarding the implementation of the recently announced Ambulatory Patient Group (APG) weight increase for services involving phosphate binders, per the New York State Medicaid Ambulatory Patient Group Weight Adjustment for Dialysis Clinics to Account for Phosphate Binder Costs article published in the August 2025 issue of the Medicaid Update.

The New York State (NYS) Medicaid payment policy, which bundled phosphate binders into the fee-for-service (FFS) dialysis clinic APG rate for NYS Medicaid-only patients (as published in the New York State Medicaid Ambulatory Patient Group Weight Adjustment for Dialysis Clinics to Account for Phosphate Binder Costs article published in the August 2025 issue of the Medicaid Update, has been delayed until January 1, 2026. Until that date, dialysis patients can continue to have prescriptions for phosphate binders filled at the pharmacy.

The NYS Medicaid FFS APG weight for APG 168 will revert to 1.3651 and will be applied retroactively to July 1, 2025. Claims processed after July 1, 2025, that were paid under the increased weight of 1.5302 will be systematically reprocessed to reimburse at the original, lower APG weight of 1.3651. This adjustment will be an automatic process, and providers will not need to resubmit claims.

Effective January 1, 2026, the APG weight will be adjusted to incorporate clinic costs associated with dispensing phosphate binders to NYS Medicaid FFS dialysis patients. Medicaid Managed Care (MMC) payments to dialysis clinics will also include phosphate binders, effective that date. This change is needed to allow for the implementation of additional eMedNY system claim processing edits necessary to ensure system integrity and program alignment. This also allows time for providers to acquire additional inventory of these drugs. Effective January 1, 2026, phosphate binder prescription drugs for dialysis patients will no longer be covered as a pharmacy benefit and must be provided by the dialysis clinic.

Questions and Additional Information:

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Drugs Administered by Practitioners: New York State Medicaid Fee-for-Service Clinical Criteria Worksheets

The New York State (NYS) Medicaid program has issued policies and billing guidance for select drugs/drug classes for practitioners including Clinical Criteria Worksheets as previously communicated in the Attention: New York State Medicaid Fee-For-Service Providers Administering Drugs article published in March 2022 issue of the Medicaid Update.

A standard worksheet can now be submitted for a practitioner administered drug that has been recently approved by the Food and Drug Administration or if the drug has not been assigned a specific Healthcare Common Procedure Coding System (HCPCS) code (i.e., "unclassified'). Unclassified codes include, but are not limited to, the following: "J3490" (unclassified drugs), "J3590" (unclassified biologicals), and "J9999" (not otherwise classified, anti-neoplastic drug). Practitioners should refer to the New York State Medicaid Practitioner Administered Drug Standard Clinical Criteria Worksheet.

Providers will submit claims, including the clinical criteria or standard worksheet where applicable, using the Medical Assistance Health Insurance Claim HCPCS code for the drug. Providers can review the eMedNY Paper Claim Form 150003- Instructions for Drugs Billed Separately. Additionally, providers should submit the associated National Drug Code, as well as 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.

Providers can review the New York State Medicaid General Professional Billing Guidelines, for claim submission guidance, including the address for submitting a claim form.

Questions and Additional Information:

  • NYS Medicaid fee-for-service (FFS) billing and claim questions should be directed to the eMedNY Call Center at (800) 343-9000.
  • NYS Medicaid FFS drug coverage and policy questions should be directed to the Office of Health Insurance Programs Division of Program Development and Management by telephone at (518) 486-3209 or by email at NYRx@health.ny.gov.

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Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene autotemcel): Centers for Medicare and Medicaid Services Cell and Gene Therapy Access Model

The New York State (NYS) Department of Health (DOH) has applied to participate in the federal Centers for Medicare and Medicaid Services (CMS) Cell and Gene Therapy (CGT) Access Model. The CMS CGT Access Model is voluntary for State Medicaid programs, as well as manufacturers, and will test whether a CMS-led approach to developing outcomes-based agreements (OBAs) for cell and gene therapies increases Medicaid members access to innovative treatment, improve health outcomes, and reduces health care costs to State Medicaid programs. The initial focus of the model is on gene therapies for individuals living with sickle cell disease, inclusive of Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene autotemcel).

With CMS-approval to participate in the CMS CGT Access Model, and an anticipated effective date of January 1, 2026, NYS Medicaid providers should be aware of the following coverage guidelines:

  • Casgevy™ and Lyfgenia® will be reimbursed by the NYS Medicaid fee-for-service (FFS) program for Medicaid Managed Care (MMC) enrollees and Medicaid FFS members.
  • For MMC enrollees, consideration of approval for treatment-related medical care will be determined by the individual managed care plan.
  • Gene therapy coverage will be in accordance with Food and Drug Administration-approved labeling.
  • The CMS CGT Access Model also includes a fertility preservation provision provided by the manufacturers of Casgevy™ and Lyfgenia®.

Additional information regarding the CMS CGT Access Model can be found on the CMS "CGT Access Model Frequently asked Questions" web page.

Drug Claim Submission:

  • Facilities and pharmacies enrolled with NYS Medicaid will be reimbursed for the cost of Casgevy™ and Lyfgenia®.
  • Pharmacy providers must have an "0442" category of service to submit the Medical Assistance Health Insurance Claim Form (eMedNY 150003), to NYS DOH. Pharmacy providers should refer to the following for enrollment information on the eMedNY "Provider Enrollment & Maintenance" web page.
  • Providers will submit claims using the medical professional claim format with the Paper Claim Form 150003 - Instructions for Drugs Billed Separately, that includes both of the following:
    • the assigned, Healthcare Common Procedure Coding System (HCPCS) code along with the National Drug Code (NDC) associated with the drug; and
    • a copy of the drug invoice showing the actual acquisition cost of the drug, dated within six months prior to the date of service and/or should include the expiration date of the drug.

Providers may not use 340B inventory for the CGT Access Model drugs. Additional information regarding billing can be found in the eMedNY New York State Medicaid General Billing Guidelines - Professional.

Drug Administration Claim Submission:

  • For NYS Medicaid FFS members, payment for drug administration will be made through the outpatient Ambulatory Patient Groups payment when administered in a clinic setting or, if administered on an inpatient basis, following the All Patient Refined-Diagnosis Related Groups.
  • For MMC enrollees, payment for drug administration will be made through the MMC Plan. Providers should check with the MMC Plan regarding specific medical coverage criteria, and reimbursement. MMC Plan contact and plan directory information is located on the NYS DOH "Medicaid Managed Care Plan Information" web page.

Questions and Additional Information:

  • NYS Medicaid FFS billing and claim questions should be directed to the eMedNY Call Center at (800) 343-9000.
  • NYS Medicaid FFS drug coverage and policy questions should be directed to the Office of Health Insurance Programs Division of Program Development and Management by telephone at (518) 486-3209 or by email at NYRx@health.ny.gov.

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Health Resources and Services Administration 340B Rebate Model Pilot Program and Its Effect on NYRx

Effective January 1, 2026, the federal 340B Rebate Model Pilot program will begin. This 340B Rebate Model Pilot program differs from the traditional 340B model. In the traditional 340B model, the 340B program operates as an upfront discount. In the federal 340B Rebate Model Pilot program, the Covered Entity will purchase the drug at a higher price upfront and then later receive a post-purchase rebate that reflects the difference between the higher initial price and the 340B price. Manufacturers and drugs subject to the 340B Rebate Model Pilot program are shown on the Health Resources and Services Administration (HRSA) "340B Rebate Model Pilot Program" web page.

What Does This Rebate Model Mean to Pharmacies Submitting 340B Rebate Model Pilot Program-Identified Drugs to NYRx, the New York State Medicaid Pharmacy Program?

There is no change to how these drugs must be submitted to NYRx. The pharmacy still must ensure the claim is appropriately identified with claim level identifiers and also must be submitted at the 340B ceiling price. As a reminder, pharmacy providers must comply with New York State (NYS) Medicaid policy for 340B drug claims, as outlined in the NYRx, Medicaid Pharmacy Program – Pharmacy Manual Policy Guidelines, articles published in the Medicaid Update. Additionally, 340B drug claims submitted to NYS Medicaid via the National Council for Prescription Drug Programs D.0 format are:

  • required to be properly identified as 340B for both fee-for-service (FFS) and Medicaid Managed Care (MMC) enrollees; and
  • must be submitted at the 340B acquisition cost by invoice to the provider for FFS members and MMC enrollees, net any manufacturer discounts and/or other price reductions or for the drugs identified for the 340B Rebate Model Pilot program, the ceiling price identified in the rebate model's Information Technology (IT) platform.

Pharmacies may review edits they encounter when billing, per the Reminder: Pharmacies Submitting Medicaid 340B Drug Claims article published in the February 2024 issue of the Medicaid Update.

Resources:

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The Medicaid Update is a monthly publication of the New York State Department of Health.

Kathy Hochul
Governor
State of New York

James McDonald, M.D., M.P.H.
Commissioner
New York State Department of Health

Amir Bassiri
Medicaid Director
Office of Health Insurance Programs