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How to start an opioid treatment program (methadone clinic) in Texas

An opioid treatment program (OTP) is the only place methadone can be dispensed for opioid use disorder. Opening one in Texas takes four approvals from four bodies, in an order that loops back on itself. Here's each one, what SAMHSA's 2024 rewrite of 42 CFR Part 8 changed, the Texas rules, and how Medicare and Texas Medicaid pay. Written by the team that runs a licensed Texas outpatient SUD program.

Updated October 24, 2026. Not legal or medical advice: OTP rules are federal and state, and they change. Confirm the current requirements with SAMHSA, the DEA, HHSC and a health-care attorney.

The short answer: a Texas OTP needs SAMHSA certification under 42 CFR Part 8 (filed online on Form SMA-162), accreditation by a SAMHSA-approved accrediting body, a DEA narcotic treatment program registration (Form 363, renewed every year), and an HHSC narcotic treatment program license (Form 3203) under Health and Safety Code chapter 466 and 26 TAC chapter 563. SAMHSA grants a provisional certification once you've applied for accreditation, and its approval depends on the state and DEA approvals, so file all three together. Revenue waits for full certification: Medicare won't enroll an OTP on a provisional certification, and Texas Medicaid requires an OTP to be enrolled in Medicare first.

The four approvals

Approval	Who grants it	The authority	The filing
OTP certification	SAMHSA	42 CFR Part 8	Form SMA-162 online, provisional first
Accreditation	A SAMHSA-approved accrediting body (CARF and the Joint Commission are among them)	42 CFR Part 8 and the accreditor's OTP standards	The accreditor's application; proof of it goes with the provisional certification request
Narcotic treatment program registration	DEA Diversion Control	Controlled Substances Act; 21 CFR Part 1301	Form 363; renewal on Form 363a, every year
Narcotic treatment program license	Texas HHSC	Health and Safety Code chapter 466; 26 TAC chapter 563	Form 3203, with the fee

Before any of them: the city. Get written confirmation that an OTP is allowed at the address. The ADA protects people in treatment for opioid use disorder, including people taking methadone (DOJ guidance), but a zoning fight still costs months. Ask your attorney about it before you sign a lease.

The order to file in

The approvals depend on each other. HHSC's narcotic treatment program page says it needs SAMHSA certification and a DEA site registration before it will consider the state license, while SAMHSA's OTP FAQs say its approval is contingent on state and DEA approval, and that the DEA and state applications should be filed at the same time as SAMHSA's. In practice:

Apply for accreditation with a SAMHSA-approved body. You need proof of that application for the next step.
File SMA-162 for provisional certification with SAMHSA, with the accreditation application attached. SAMHSA asks for 45 days to decide on a provisional application.
File the DEA Form 363 and the HHSC Form 3203 at the same time, and get the site ready for the DEA's security review and HHSC's inspection.
Open under provisional certification once SAMHSA, the DEA and HHSC have all approved.
Pass the accreditation survey and convert to full SAMHSA certification. Then enroll with Medicare, then Texas Medicaid.

Ask each agency to confirm this sequence for your program before you file; the forms and instructions are updated more often than the rules.

SAMHSA certification

The form. New programs file the online Form SMA-162, "Application for Certification to Use Opioid Drugs in a Treatment Program," and check the provisional certification box (SAMHSA OTP FAQs).
Accreditation evidence. A provisional application must show a separate application for OTP accreditation with one of SAMHSA's approved accrediting bodies. A program whose certification expires is treated as new and starts over with provisional certification.
The standards you'll be held to are the federal opioid treatment standards in 42 CFR 8.12: administrative and organizational structure, patient admission criteria, the initial and periodic assessments, treatment planning, counseling, drug testing, recordkeeping, medication administration, dispensing and storage, and take-home doses. Write the policy manual against it section by section.

Accreditation is the long pole. Our guides on accreditation for new programs, Joint Commission vs. CARF and the mock survey apply to OTPs too, with the accreditor's OTP standards on top.

What the 2024 Part 8 rule changed

SAMHSA's final rule, "Medications for the Treatment of Opioid Use Disorder," was published February 2, 2024, took effect April 2, 2024, and required full compliance by October 2, 2024 (Federal Register; SAMHSA's summary of changes). What matters for a new program:

Topic	Before	Since 2024
Admission	At least a 1-year history of opioid addiction	The 1-year history requirement is gone
Take-home methadone	Earned over months and years of treatment	Possible from the first week, on the practitioner's judgment: up to 7 days in the first 14 days of treatment, up to 14 days from day 15, and up to 28 days from day 31, with diversion controls
Telehealth	In-person examination before starting	Buprenorphine can be started after an audio-only or audio-visual evaluation, and methadone after an audio-visual one, when the practitioner decides a remote evaluation is adequate
Counseling	Commonly treated as a condition of dosing	Counseling must be offered, but a patient declining it doesn't bar them from medication

The take-home tiers match SAMHSA's methadone take-home guidance and the rule's text in 42 CFR 8.12. States may set stricter take-home rules, so check 26 TAC chapter 563 and ask HHSC how Texas applies them before you write your take-home policy.

The DEA registration

The form. Narcotic treatment programs register on DEA Form 363 and renew on Form 363a. The Controlled Substances Act requires practitioners who dispense narcotic drugs for maintenance or detoxification to register every year (DEA notice on Forms 363 and 363a, 2025). Check the current fee on DEA Diversion Control when you apply.
Security. The physical security controls for stored controlled substances (safes or vaults, alarms, who has access) are in 21 CFR 1301.71 to 1301.76. Design the dispensing area and the medication room to them before construction, not after the DEA visit.
Records. Every dose is a controlled substance transaction: receipts, dispensing records, inventories and disposal. Your dispensing system and your EHR must agree to the milligram.
Texas has no separate state controlled-substance registration to add; it ended in 2016.

The Texas license and rules

The rules moved. Texas's narcotic treatment program rules are now 26 TAC chapter 563, Minimum Standards for Narcotic Treatment Programs. HHSC transferred them from 25 TAC chapter 229, subchapter J, on November 29, 2024 (HHSC). Older guides and policy manuals that cite 25 TAC 229 need updating.
The application. The initial application is HHSC Form 3203, sent with the license fee and supporting documents. HHSC's Health Facility Licensing Unit won't process it until HHSC Accounts Receivable has received and posted the fee.
Medication units. HHSC licenses narcotic treatment programs and their medication units (dosing sites that operate under a parent OTP). Plan any satellite with HHSC from the start.
The central registry. 26 TAC 563.150 covers the central registry programs use so a patient isn't enrolled at more than one OTP at once. Build the registry check into admission.
Hospitals. 26 TAC 563.151 covers hospitals approved for narcotic drug detoxification treatment, a separate path from a community OTP.
The rest of the chapter (sections 563.141 to 563.153) sets state operational requirements on top of the federal ones. Read it whole before you write policies; where Texas and 42 CFR Part 8 differ, follow the stricter rule and ask HHSC.

An OTP is a different license from the chemical dependency treatment facility license that IOPs and residential programs hold (the CDTF license guide). If you plan to offer an IOP alongside dosing, ask HHSC in writing which licenses the combined program needs, and see our guide to starting an IOP in Texas. For the other kinds of Texas programs, see starting a detox center, a residential treatment center and a mental health clinic.

Staff and services

Program sponsor and medical director. 42 CFR 8.12 makes the program sponsor responsible for the program and the medical director, a physician, responsible for its medical services. The director's experience in addiction medicine is what accreditors and HHSC will look at first; see hiring a medical director.
Practitioners and nurses. Admission examinations, dosing orders, take-home decisions and dispensing are clinical and nursing work every day the clinic doses, including weekends and holidays if you don't give take-homes for them.
Counselors for the counseling the program must offer, with treatment plans and periodic reviews.
Drug testing under 42 CFR 8.12, with a CLIA certificate for anything tested on site (CLIA waivers) and a written drug testing policy.
Naloxone for overdose response on site and in every patient's hand; see our naloxone policy guide.
Records privacy. An OTP is a federally assisted SUD program, so 42 CFR Part 2 governs its records and consents.

Programs that don't want to dispense methadone themselves can coordinate with an OTP instead: our guide to adding MAT to an IOP covers that partnership and buprenorphine prescribing, which doesn't need an OTP.

Medicare, Medicaid and other payers

Payer	How it works	What it needs from you
Medicare	Since January 1, 2020, Medicare pays OTPs weekly bundled payments for opioid use disorder treatment, for example G2067 (methadone) and G2068 (oral buprenorphine), covering the medication, counseling, therapy and toxicology testing (CMS OTP page)	Full SAMHSA certification and accreditation; CMS doesn't accept provisional certification. Enroll on the CMS-855B in PECOS and bill on the CMS-1500 (CMS OTP enrollment)
Texas Medicaid	TMHP opened Medicaid enrollment to OTPs on December 14, 2019, as a new provider type	An HHSC narcotic treatment program license, active Medicare enrollment, and a principal information form for a medical director licensed by the Texas Medical Board (TMHP enrollment notice). Then a contract with each Medicaid plan; see Texas Medicaid credentialing
Commercial plans	Coverage and codes vary by plan; many use HCPCS H0020 for methadone administration	A facility contract per plan; ask each plan what it pays and on which codes. Our credentialing service files and follows them

Because Medicare requires full certification and Texas Medicaid requires Medicare, an OTP's first months are often self-pay and commercial. Put that gap in the business plan and the startup budget.

Step by step

Test the market and the site: local need, the nearest OTPs, the payers, and the city's written answer on zoning.
Engage a health-care attorney: ownership, the medical director arrangement, zoning and the ADA.
Form the entity and get the EIN; keep the legal name identical across SAMHSA, DEA, HHSC and payer filings.
Sign the medical director and design the dispensing area and medication room to the DEA's security rules.
Write the policy manual against 42 CFR 8.12, 26 TAC 563 and the accreditor's OTP standards: admission, dosing, take-homes, diversion control, drug testing, counseling, the central registry and emergencies.
Apply for accreditation.
File SMA-162 (provisional), DEA Form 363 and HHSC Form 3203 together, with the HHSC fee.
Hire and train the team; prepare for the DEA review and HHSC inspection.
Open under provisional certification once all three approve.
Pass the accreditation survey, get full certification, then enroll with Medicare and Texas Medicaid and contract with the Medicaid plans.

Building an OTP?

We don't sell a flat-fee OTP package, because every OTP's federal, state and accreditation work is different. We scope it on a free call and price the pieces: the policy and procedure manual written against 42 CFR 8.12, 26 TAC 563 and the accreditor's standards ($7,500), accreditation readiness through the survey ($16,500), a full mock survey before the real one ($6,500), and facility contracts with each plan. Adding an IOP beside the dosing clinic? The IOP / PHP Program Launch is $39,500, and the HHSC application for its CDTF license is $7,500.

Book a free call

Service	Price
Program policy and procedure manual A full policy manual written for your program, organized by accreditation chapter, in Word. Includes: Every chapter: rights, care, records, medications, infection control, safety, emergency management, HR, leadership, performance improvement; Environment-of-care and emergency plans; State-rule crosswalk; Editable Word files.	$7,500
Accreditation readiness Get ready for a Joint Commission or CARF survey: a gap assessment, a fix plan and the evidence surveyors ask for. Includes: Gap assessment against the standards; Policy and chart fixes; Staff training and tracer practice; Application and survey scheduling; A full mock survey.	$16,500
Mock survey A one-day survey the way an accreditor or state surveyor would do it, with a written report and fix list. Includes: Leadership, environment and record tracers; Chart audit sample; Written findings and corrective-action plan.	$6,500
Facility or group contract: one plan A program or group contract with one insurance plan: the organization application, site visit and contract. Includes: Organization application; Site visit preparation if the plan does one; Contract and rate review checklist; Effective date and billing set-up confirmed.	$950 per plan

Questions

What do you need to open a methadone clinic in Texas?

Four approvals: SAMHSA certification as an opioid treatment program (42 CFR Part 8), accreditation by a SAMHSA-approved body, a DEA narcotic treatment program registration, and an HHSC narcotic treatment program license under Health and Safety Code chapter 466 and 26 TAC chapter 563. The city must also allow the use at your address.

How do you get SAMHSA OTP certification?

File the online Form SMA-162 and request provisional certification, with proof you've applied for OTP accreditation with a SAMHSA-approved accrediting body. SAMHSA asks for 45 days to decide, and its approval depends on the state and DEA approvals, so file those at the same time.

What are the Texas rules for narcotic treatment programs?

26 TAC chapter 563, Minimum Standards for Narcotic Treatment Programs, which HHSC moved from 25 TAC chapter 229, subchapter J, on November 29, 2024. The license application is HHSC Form 3203.

How many take-home doses can an OTP give now?

Under the 2024 federal rule, on the practitioner's judgment: up to 7 days of take-homes in the first 14 days of treatment, up to 14 days from day 15, and up to 28 days from day 31. State rules may be stricter, so check 26 TAC chapter 563.

Does Medicare pay for methadone treatment?

Yes. Since 2020 Medicare pays enrolled OTPs weekly bundled payments, such as G2067 for methadone. The OTP needs full SAMHSA certification and accreditation to enroll; provisional certification isn't accepted.

Does Texas Medicaid cover methadone?

Texas Medicaid enrolls opioid treatment programs that hold an HHSC narcotic treatment program license and are actively enrolled in Medicare. Members in managed care also need the OTP to be in their plan's network.

Can a doctor prescribe methadone for addiction in an office?

No. Methadone for opioid use disorder can only be dispensed by a certified OTP. Buprenorphine is different: any practitioner with a DEA registration that covers Schedule III can prescribe it for opioid use disorder, where state law allows.

Sources

Cima Consulting isn't a law firm and doesn't give legal or medical advice. SAMHSA, the DEA, HHSC, accreditors and payers make their own decisions; no one can promise an approval or a date.

Four approvals, one plan.

A free 30-minute call: your site, your sequence, and what each agency will ask for.