DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Medicaid and Medical Assistance

PROPOSED

PUBLIC NOTICE

Vaccines

In compliance with the State's Administrative Procedures Act (APA - Title 29, Chapter 101 of the Delaware Code) and under the authority of 31 Del.C. §512, Delaware Health and Social Services ("Department") / Division of Medicaid and Medical Assistance (DHSS/DMMA) is proposing to amend Title XIX Medicaid State Plan General Program Administration and Table of Contents page 66b, Attachment 3.1-A page 6 Addendum 1, Attachment 4.19-B Intro page 5, Attachment 4.19-B Intro page 6, and Attachment 4.19-B Intro page 7.3, specifically, to modify the reimbursement methodology for vaccines and vaccine administration.

Any person who wishes to make written suggestions, compilations of data, testimony, briefs, or other written materials concerning the proposed new regulations must submit same to, Planning and Policy Unit, Division of Medicaid and Medical Assistance, 1901 North DuPont Highway, P.O. Box 906, New Castle, Delaware 19720-0906, by email to DHSS_DMMA_Publiccomment@Delaware.gov, or by fax to 302-255-4413 by 4:30 p.m. on October 31, 2024. Please identify in the subject line: Vaccines

The action concerning the determination of whether to adopt the proposed regulation will be based upon the results of Department and Division staff analysis and the consideration of the comments and written materials filed by other interested persons.

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 Vaccines.

Statutory Authority

Background

On June 27, 2023, the Centers for Medicare & Medicaid Services (CMS) issued guidance on section 11405 of the IRA (Pub. L. 117-169). Statutory amendments made by section 11405 of the IRA require Medicaid coverage and payment for approved adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and their administration, without cost sharing.

Vaccines administered to recommended populations at recommended intervals can reduce morbidity, hospitalizations, and deaths, and save costs. Vaccines may reduce the overall burden of infections, which remain high in the United States. For example, the Centers for Disease Control and Prevention (CDC) estimates that influenza has resulted in between 140,000 to 710,000 hospitalizations and 12,000 to 52,000 deaths annually between 2010 and 2020. An estimated 150,000 individuals per year are hospitalized because of pneumococcal pneumonia. In 2020, there were 5 newly reported cases of hepatitis B per 100,000 persons. The human papillomavirus (HPV) causes more than 37,000 cases of cancer each year.

Vaccination rates are suboptimal for all adults, regardless of health coverage, but for adults enrolled in Medicaid, the vaccination rates for a range of vaccinations are lower than for adults with private health insurance coverage, including influenza, tetanus, herpes zoster, hepatitis A, hepatitis B, and HPV vaccinations. Additionally, the COVID-19 public health emergency (PHE) had a negative impact on the rate of children receiving routine childhood vaccinations. Although child vaccination rates have rebounded since the beginning of the COVID-19 PHE, there is still a gap in child vaccinations compared to prior years.

DMMA will pay for vaccines that are recommended by the Advisory Committee on Immunization Practices (ACIP) and will be covered for adults 18 and older with no cost share.

Summary of Proposal

Purpose

The purpose of this proposed regulation is to comply with the Inflation Reduction Act (IRA) requirement to attest to the coverage of all Advisory Committee on Immunization Practices (ACIP) recommended vaccines and their administration.

Summary of Proposed Changes

Effective October 1, 2024, the DHSS/DMMA proposes to amend Title XIX Medicaid State Plan to modify the reimbursement methodology for vaccines and vaccine administration.

Public Notice

In accordance with the federal public notice requirements established in 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 gives public notice and provides an open comment period for 30 days to allow all stakeholders an opportunity to provide input on the proposed regulation. Comments must be received by 4:30 p.m. on October 31, 2024.

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 provide 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

Attachment 3.1-A

Page 6 Addendum 1

STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT

STATE/TERRITORY: DELAWARE

LIMITATIONS ON AMOUNT, DURATION AND SCOPE OF MEDICAL AND REMEDIAL CARE AND SERVICES PROVIDED TO THE CATEGORICALLY NEEDY

13.c. Preventive Services

In accordance with section 4106 of the Affordable Care Act, Delaware Medicaid Covers and reimburses all preventative services assigned a grade of A or B by the United States Preventive Services Task Force (USPSTF), all approved vaccines and their administration, recommended by the Advisory Committee on Immunization Practices (ACIP), and behavioral interventions to treat Autism Spectrum Disorder (ASD) without cost-sharing. As changes are made to USPSTF recommendations, the State will update the coverage and billing codes to comply with these revisions.

The State covers all Federal Drug Administration (FDA) approved adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), and their administration, without cost-sharing. The state has methods to ensure that, as changes are made to ACIP recommendations, coverage and billing codes will be updated to comply with those revisions.

Preventative services are any medical or remedial services recommended by a physician or other licensed practitioner of the healing arts acting within the scope of their practice under State law and include all preventive services not otherwise covered under the State Plan pursuant to Section §1905(r)(5) of the Social Security Act, Early and Periodic Screening, Diagnostic, and Treatment Services, for other necessary health care, diagnostic services, treatment, and other measures described in section 1905(a) to correct or ameliorate defects and physical and mental illnesses and conditions discovered by the screening services, whether or not such services are covered under the State plan. Preventive Services are reimbursed according to the methodologies for services described in Attachment 4.19-B. Methods and Standards for Establishing Payment Rates - Other Types of Care, of the State Plan.

The State assures the availability of documentation to support the claiming of federal reimbursement for these preventative services.

The State assures that the benefit package will be updated as changes are made to the USPSTF and ACIP recommendation, and that the State will update the coverage and billing codes to comply with these revisions.

Attachment 4.19-B

Introduction - Page 6

OMB No. 0938-1148

STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT

STATE/TERRITORY: DELAWARE

METHODS AND STANDARDS FOR ESTABLISHING PAYMENT RATES -

OTHER TYPES OF CARE

Physician Services

Increased Primary Care Service Payment 42 CFR 447.405, 447.410, 447.415

Attachment 4.19-B: Physician Services 42 CFR 447.405 Amount of Minimum Payment Continued

Effective Date of Payment

E & M Services

This reimbursement methodology applies to services delivered on and after January 1, 2013, ending on

December 31, 2014 but not prior to December 31, 2014. All rates are published at

(http://www.dmap.state.de.us/home/index.html).

https://medicaidpublications.dhss.delaware.gov/docs/search?EntryId=1080

Vaccine Administration

This reimbursement methodology applies to services delivered on and after January 1, 2013, ending on

December 31, 2014 but not prior to December 31, 2014 October 1, 2024. All rates are published at

(http://www.dmap.state.de.us/home/index.html).

https://medicaidpublications.dhss.delaware.gov/docs/search?EntryId=1080

PRA Disclosure Statement

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1148. The time required to complete this information collection is estimated to average 20 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-0S, Baltimore, Maryland 21244-1850.

Attachment 4.19-B

Introduction - Page 7.3

OMB No. 0938-1148

STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT

STATE/TERRITORY: DELAWARE

METHODS AND STANDARDS FOR ESTABLISHING PAYMENT RATES -

OTHER TYPES OF CARE

Physician Services

Medicaid Payment for Primary Care Services CONTINUED

Effective Date of Payment

a. Evaluation & Management Services

This reimbursement methodology applies to services delivered on or after January 1, 2015. The fee schedule and any annual/periodic adjustments to the fee schedule are available on the Delaware Medical Assistance Program (DMAP) website at:

http://www.dmap.state.de.us/downloads/feeschedules.htmI

https://medicaidpublications.dhss.delaware.gov/docs/search?EntryId=1080

Except as otherwise noted in the plan, State developed fee schedule rates are the same for both government and private providers.

b. Vaccine Administration

This reimbursement methodology applies to services delivered on or after January 1, 2015. The fee schedule and any annual/periodic adjustments to the fee schedule are available on the Delaware Medical Assistance Program (DMAP) website at:

http://www.dmap.state.de.us/downloads/feeschedules.htmI

https://medicaidpublications.dhss.delaware.gov/docs/search?EntryId=1080

Except as otherwise noted in the plan, State-developed fee schedule rates are the same for both government and private providers.

*Please Note: Due to formatting of certain amendments to the regulation, they are not being published here. Copies of the documents are available at:

https://regulations.delaware.gov/register/october2024/proposed/66b Amended.pdf

https://regulations.delaware.gov/register/october2024/proposed/Attachment 4.19-B Intro Page 5 Amended.pdf