Department of Health and Social Services

Division of Medicaid and Medical Assistance

Statutory Authority: 31 Delaware Code, Section 512 (31 Del.C. §512)

FINAL

ORDER

Glucagon-Like Peptide-1 (GLP-1)

NATURE OF THE PROCEEDINGS:

Delaware Health and Social Services (“Department”) / Division of Medicaid and Medical Assistance initiated proceedings to amend Title XIX Medicaid State Plan regarding Glucagon-Like Peptide-1 (GLP-1), specifically, to broaden the language in the State Plan with guidance from CMS, to provide the state with increased flexibility to determine coverage of drugs for anorexia, weight loss, and weight gain without additional changes to the State Plan. The Department’s proceedings to amend its regulations were initiated pursuant to 29 Del.C. §10114 and its authority as prescribed by 31 Del.C. §512.

The Department published its notice of proposed regulation changes pursuant to 29 Del. C. §10115 in the July 2026 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by July 31, 2026, at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.

SUMMARY OF PROPOSAL

The purpose of this notice is to advise the public that Delaware Health and Social Services (DHSS)/Division of Medicaid and Medical Assistance (DMMA) is proposing to amend Title XIX Medicaid State Plan regarding GLP-1.

Background

This change is administrative in nature. It aligns the State Plan language with current coverage practice and is not intended to change which medications/agents/drugs are covered or the criteria for coverage. The category of drugs to treat weight conditions is undergoing rapid change. The state seeks to update the language in the State Plan to increase flexibility to determine coverage of these medications, including participation in federal and manufacturer models designed to improve access and improve pricing, without the need to make additional changes to the State Plan. The proposed change removes specific language about state coverage of weight loss drugs and replaces it with more general language that indicates that select agents for anorexia, weight loss, and weight gain will be covered as listed on the state's website. This change enables the state to determine and communicate coverage of drugs for these indications directly through the state's website.

Statutory Authority

• 42 CFR §440.120

Purpose

The purpose of this regulation is to provide the state with increased flexibility to determine coverage of drugs for anorexia, weight loss, and weight gain without additional changes to the State Plan.

Summary of Proposed Changes

Effective January 1, 2026, the DHSS/DMMA proposes to amend Title XIX Medicaid State Plan to clarify criteria for GLP-1.

Public Notice

In accordance with the federal public notice requirements established at Section 1902(a)(13)(A) of the Social Security Act and 42 CFR 440.386 and the state public notice requirements of Title 29, Chapter 101 of the Delaware Code, DHSS/DMMA gave public notice and provided an open comment period for 30 days to allow all stakeholders an opportunity to provide input on the proposed regulation. Comments were to have been received by 4:30 p.m. on July 31, 2026.

Centers for Medicare and Medicaid Services Review and Approval

The provisions of this state plan amendment (SPA) are subject to approval by the Centers for Medicare and Medicaid Services (CMS). The draft SPA page(s) may undergo further revisions before and after submittal to CMS based upon public comment and/or CMS feedback. The final version may be subject to significant change.

Provider Manuals and Communications Update

Also, there may be additional provider manuals that may require updates as a result of these changes. The applicable Delaware Medical Assistance Program (DMAP) Provider Policy Specific Manuals and/or Delaware Medical Assistance Portal will be updated. Manual updates, revised pages or additions to the provider manual are issued, as required, for new policy, policy clarification, and/or revisions to the DMAP program. Provider billing guidelines or instructions to incorporate any new requirement may also be issued. A newsletter system is utilized to distribute new or revised manual material and to provide any other pertinent information regarding DMAP updates. DMAP updates are available on the Delaware Medical Assistance Portal website: https://medicaid.dhss.delaware.gov/provider

Fiscal Impact Statement

There is no anticipated fiscal impact.

Summary of Comments Received with Agency Response and Explanation of Changes

Comment: A suggestion was received about ensuring safeguards are in place such as, accessible and easy-to-find coverage information, protection of medically necessary treatment, ability to expand coverage as evidence changes, and public record of coverage changes.

Agency Response: DMMA appreciates the commenters thorough review of the proposed regulation and thoughtful recommendations. We will take this into consideration.

DMMA thanks the following commenter for their engagement and consideration of this important issue:

State Council for Persons with Disabilities (SCPD)

IMPACT ON THE STATE'S GREENHOUSE GAS EMISSIONS REDUCTION TARGETS AND RESILIENCY TO CLIMATE CHANGE:

The DMMA Division Director has reviewed the proposed regulation as required by 29 Del. C. §10118(b)(3) and has determined that if promulgated, the regulation would have a de minimis impact on the State's resiliency to climate change because neither implementation nor compliance with the regulation would reasonably involve the increase in greenhouse gas emissions.

FINDINGS OF FACT:

The Department finds that the proposed changes as set forth in the July 2026 Register of Regulations should be adopted.

THEREFORE, IT IS ORDERED, that the proposed regulation to amend Title XIX Medicaid State Plan regarding GLP-1, specifically, to broaden the language in the State Plan with guidance from CMS and to provide the state with increased flexibility to determine coverage of drugs for anorexia, weight loss, and weight gain without additional changes to the State Plan is adopted and shall be final effective ten days after publication in the Register.

8/14/2026

Date of Signature Christen Linke Young, Secretary, DHSS