TX HHS Form 3204. End Stage Renal Disease Facility License Application

Form 3204 is the official application used to obtain, transfer, or relocate a license for an End Stage Renal Disease (ESRD) facility in Texas. This document is required for any organization that intends to operate a dialysis center, whether it provides in-center hemodialysis, home dialysis training, or pediatric services. Because dialysis facilities handle life-sustaining treatment for patients with kidney failure, the Texas Health and Human Services Commission (HHSC) requires detailed disclosure about ownership, personnel, facility readiness, and compliance history.

This guide explains every section of Form 3204 in practical, expert-level terms to help you complete it correctly, avoid delays, and understand your obligations under Texas law.

Purpose of Form 3204

The form serves three key purposes:

• Licensing — issuing a new ESRD facility license.
• Change of Ownership (CHOW) — notifying the state when facility ownership transfers to another entity.
• Relocation — approving a facility move to a new address.

Texas requires this level of scrutiny because ESRD facilities provide critical treatment regulated under federal CMS guidelines and state health-safety laws. Operating without a valid license can result in penalties, forced closure, or loss of Medicare/Medicaid certification.

Section-by-Section Explanation

Section 1 – Facility Information

This section identifies the facility's physical and mailing address, DBA name, and main contact numbers. The DBA must match signage and all public-facing materials. A mismatch is a frequent reason HHSC delays applications. For initial and relocation applications, you must provide the projected opening date and any associated architectural project number.

• Common mistake: Using a corporate name instead of the DBA that patients will see.
• Who completes this: The facility administrator or compliance officer familiar with the physical site.

Section 2 – Ownership Information

This section names the legal owner responsible for daily operations—whether a corporation, LLC, hospital system, or sole proprietor. Texas requires supporting documents, including the IRS EIN letter, Certificate of Filing from the Secretary of State, and an organizational chart showing ownership layers.

Ownership type matters because additional disclosures are required for partnerships, hospital districts, and multi-facility operators.

• Frequent errors: Missing EIN documentation or outdated organizational charts.
• Legal consequences: Incorrect ownership disclosure may delay approval or trigger compliance review.

Section 3 – Ownership and Control Interest Disclosure

This section requires a full two-year compliance and legal history of the owner or controlling entity. You must report:

• Evictions from healthcare properties
• Tax liens or unpaid judgments
• Criminal convictions (misdemeanor or felony)
• Medicare/Medicaid sanctions
• License revocations, denials, or enforcement actions anywhere in the U.S.

Any “Yes” answer requires a detailed explanation. HHSC uses this information to evaluate whether the operator meets state suitability requirements for healthcare providers.

• Note: Withholding information can result in denial or later enforcement.
• Practical tip: Prepare all documentation before submitting the form to prevent incomplete filing notices.

Section 4 – Personnel

Every ESRD facility must maintain qualified clinical personnel. The application requires:

• Board-certified Medical Director
• Supervising Nurse
• Social Worker
• Dietitian

For each, include name, license number, and expiration date. These roles are mandated by federal Conditions for Coverage (42 CFR § 494) and Texas ESRD licensing rules.

Typical mistake: Listing a licensed professional who has not formally agreed to serve in that role.

Section 5 – Dialysis Services

This section defines the types of services your facility will offer:

• Adult, pediatric, or combined services
• In-center hemodialysis
• Home hemodialysis
• Home peritoneal dialysis

You must also identify whether you have an isolation room or are claiming a CMS waiver. For CHOW applications, you may select options applicable to pre-2009 facilities.

Section 6 – Dialysis Stations

List the exact number of stations for each type of dialysis treatment. Texas requires prior approval before adding or removing stations, as capacity affects staffing, emergency planning, and community need.

Tip: Double-check station counts with your architectural submission to avoid discrepancies.

Section 7 – License Fee

Most applicants must pay a licensing fee unless the facility is state-operated. The fee amount varies by license action.

Practical Recommendations

• Gather all ownership documents before starting the application.
• Ensure all professional licenses are active and unexpired.
• Prepare explanations for any “Yes” answers in Section 3—concise but complete.
• Match the DBA across all documents, signage plans, and advertisements.
• Verify that architectural project numbers match those submitted to the state.

Examples of Real-Life Situations

• A hospital system opening a new outpatient dialysis unit must file Form 3204 for an initial license and attach an EIN letter and ownership structure.
• An independent dialysis center purchased by a national chain must complete a CHOW filing, disclose all ownership changes, and provide a transfer date.
• A pediatric dialysis program relocating to a larger building submits a relocation application with station counts and architectural approvals.
• A facility adding home hemodialysis training updates its service profile through this form.

Documents Commonly Required

• IRS EIN assignment letter
• Certificate of Filing from Texas SOS
• Organizational ownership chart
• Architectural project documentation
• Professional licenses for medical staff
• Explanatory statements for any disclosures

FAQ

• Who must file Form 3204? Any entity opening, relocating, or assuming ownership of an ESRD facility in Texas.
• How long does approval take? Processing varies, but complete applications typically move faster. Missing documents cause delays.
• Do I need an architectural project number? Yes, for initial and relocation applications involving new or modified space.
• What if my facility has prior Medicare sanctions? You must disclose them and provide documentation; nondisclosure may result in denial.
• Can licenses transfer automatically during CHOW? No. A CHOW application is mandatory.
• Are pediatric services treated differently? Yes; staffing and equipment must reflect pediatric standards.
• What happens after submission? HHSC reviews ownership, compliance history, staffing, and site readiness before issuing a license.

Micro-FAQ

• Purpose? Licensing ESRD facilities in Texas.
• Who files? Owners or operators of dialysis centers.
• Deadline? Before opening, relocating, or completing a CHOW.
• Attachments? EIN letter, SOS filing, org chart, licenses.
• Submitted to? Texas Health and Human Services Commission.
• Criminal history required? Yes, for owners and controlling entities.
• Architectural number? Required for new or relocated facilities.
• Station changes? Must be approved before implementation.
• Isolation room? Required unless a valid CMS waiver exists.
• Professional roles? Medical Director, Supervising Nurse, Social Worker, Dietitian.

Related Forms

• Texas ESRD Facility Change of Information Form
• Texas Health Facility License Renewal Form
• Medicare ESRD Certification Application (CMS-855A)
• Facility Relocation Architectural Review Package

Form Details

• Form Name: End Stage Renal Disease Facility License Application
• Form Number: 3204
• Region: State of Texas
• Revision Date: February 2023