Controlled substance agreement

Key takeaways

A controlled substance agreement (CSA) is a formal document setting expectations between provider and patient when prescribing opioids, benzodiazepines, or stimulants long term.

CDC opioid prescribing guidelines recommend CSAs to document informed consent and set monitoring protocols, such as urine drug screens and a single-provider policy.

Every CSA needs patient responsibilities, provider obligations, drug testing consent, refill rules, consequences of non-compliance, and signature blocks. State law decides whether one is mandatory.

Practice management software like Pabau stores signed CSAs in the patient record, flags annual renewals, and keeps monitoring results alongside the agreement.

A controlled substance agreement (CSA) is a written document that sets the terms under which a provider prescribes controlled medications. It records what the patient agrees to in return, from drug screens to using a single prescriber.

This guide covers what belongs in each section of the form and the ICD-10 code practices use to record a signed copy. It also covers the telehealth rules that catch providers out, where state law makes an agreement mandatory, and how to keep one current.

What is a controlled substance agreement?

A controlled substance agreement is a written document covering the terms of prescribing and the patient’s obligations during treatment. You will also see it called a pain contract, a narcotic agreement, or a drug contract.

It applies to Schedule II-IV prescriptions. That covers opioids such as morphine and oxycodone, benzodiazepines such as alprazolam and lorazepam, and stimulants such as methylphenidate and amphetamine. Practices use the same form across chronic pain, mental health, and ADHD care.

The agreement does three jobs:

• Documents informed consent: The patient acknowledges the risks of dependence, side effects, and withdrawal.
• Sets the monitoring protocol: Urine drug screens, prescription drug monitoring program (PDMP) checks, and pill counts.
• Defines the single-provider rule: The patient gets all controlled substances from one prescriber and discloses every other prescription.

In psychiatry the agreement usually follows the first assessment, so it pairs naturally with a psychiatric evaluation template at intake.

Why providers ask patients to sign one

The Drug Enforcement Administration (DEA) does not universally mandate CSAs. But CDC opioid prescribing guidelines recommend them as a best practice, and providers use them for four reasons:

• Risk mitigation: Documents that the patient understood the addiction risk and agreed to the safeguards.
• Compliance support: Signals that controlled substance therapy comes with accountability, which supports adherence.
• Regulatory alignment: Captures the PDMP checks and consent wording state boards look for in an audit.
• Diversion prevention: Sets consequences for sharing medication, forging prescriptions, or collecting from several providers at once.

What to include in the form

A compliant agreement covers eight core sections:

• Patient and prescriber details, plus the medications the agreement covers.
• Patient responsibilities.
• Provider responsibilities.
• Consent to drug testing and monitoring.
• The single-provider and single-pharmacy policy.
• Refill rules, including how early requests are handled.
• Consequences of non-compliance.
• Signature and date blocks for the patient and the prescriber.

Patient responsibilities

This section lists what the patient commits to. Keep the wording specific, and follow the same clinical documentation standards you would apply to a treatment note.

• Take the medication only as prescribed by the authorized provider.
• Never share, sell, or give the medication to anyone else.
• Disclose in writing any controlled substance prescribed by another provider.
• Report lost, stolen, or damaged prescriptions right away. Early refills are not issued to replace them.
• Attend scheduled appointments and give a urine sample when asked.
• Store the medication securely and out of reach of others.
• Acknowledge the risks of dependence, tolerance, and withdrawal.

Provider responsibilities

Most templates carry a reciprocal section. It sets out what the practice commits to in return:

• Prescribe controlled medications only where it is clinically appropriate.
• Assess pain, function, and psychiatric symptoms at baseline and at every review.
• Check the PDMP before starting therapy and before each refill.
• Handle refill requests and any prior authorization process before the patient runs out.
• Offer or refer for addiction screening and treatment where misuse is suspected.
• Keep the record confidential and securely stored.
• Explain the risks, the benefits, and the alternatives to controlled therapy.

Drug testing and monitoring consent

The monitoring section is the provider’s authority to verify. Spell out what the patient is consenting to:

• Urine drug screens, random or scheduled, at the provider’s discretion.
• PDMP queries before each refill.
• Pill counts, where the patient brings the bottle in to be checked.
• Pharmacy contact to confirm fill dates and quantities.

Counseling time spent walking a patient through their medication plan may be billable under H0034.

Consequences of non-compliance

This is the enforcement clause. Name the violations that end the agreement and stop the prescription:

• A urine screen positive for a non-prescribed substance, or negative for the prescribed one.
• Collecting controlled substances from another provider without disclosure.
• Selling, sharing, or otherwise diverting the medication.
• Forging or altering a prescription.
• Missing scheduled appointments without reasonable notice.
• Refusing a urine screen or a pill count.
• Failing to keep the medication secure.

Termination is rarely the whole answer. Some states require a tapering plan rather than an abrupt stop, and the Americans with Disabilities Act may apply too. Sound patient compliance policy balances accountability with clinical judgment.

ICD-10 code for a signed agreement

The usual code for a signed agreement is ICD-10 code Z79.899, for long-term current use of other medication. The code tells coders and auditors that the patient sits inside a formal monitoring protocol.

Z79.899 is a convention rather than a requirement, so confirm it with your coding team and your payers. Record the signature date in the note as well as the code. That habit is basic medical billing compliance, and it is what makes the claim defensible in an audit.

Telehealth prescribing and the Ryan Haight Act

The Ryan Haight Act generally requires an in-person evaluation before a provider prescribes Schedule II substances by telehealth. A patient already established with the prescriber is one exception. Special DEA registration for certain programs is another.

The 24-month window that gets quoted belongs to a different exception. It applies to a covering practitioner, who prescribes at the request of a provider that examined the patient in person within the previous 24 months.

If you run virtual visits for controlled substance therapy, say so in the agreement. Confirm in writing that an in-person visit has happened or is scheduled, and name the exception you rely on. A mental health EMR can hold the agreement, the consent, and the visit note on one record.

Where state law makes one mandatory

Requirements vary by state, and the differences are sharper than they look. Michigan requires signed CSAs annually. Washington requires a written agreement for higher-risk chronic opioid patients. California recommends one but does not mandate it.

Check your state medical board site and your DEA state liaison’s guidance before you adopt a form. Some states also dictate the wording, such as mandatory PDMP checks or set consent language.

How to put the form into your workflow

Getting the form signed is the easy part. Keeping it current is where practices slip, so store it in your patient record management system and let automated workflows chase the renewal.

1. Create the template: Use your organization’s approved wording, or the free form above, and save it as a standard form in your EHR.
2. Get signatures: Both patient and provider sign and date at the first controlled substance prescription. Digital consent forms capture the e-signature in seconds.
3. Store it securely: Keep the signed copy in the patient’s record and note the signature date in the clinical note.
4. Set renewal reminders: Most agreements are renewed annually, or sooner if therapy changes. Automate the alert so an expiring agreement surfaces on its own.
5. Document monitoring: Log screen results, PDMP checks, and pill count dates against the record as they happen.
6. Review violations: Record the breach and your clinical response, whether that is counseling, a referral, or discontinuation.

Practices on psychiatry practice management software can automate tracking, renewals, and monitoring, which takes the admin off the front desk.

How Pabau keeps signed agreements current

Plenty of practices still run the agreement on paper. It gets printed, signed at the desk, scanned, and dropped into the patient’s file. The renewal date lives in a spreadsheet, or in the prescriber’s memory.

Practice management software like Pabau replaces that loop with a digital form. The patient signs on screen, and the agreement files itself against their record with the date attached. Drug screen results, PDMP notes, and pill counts sit on the same timeline.

Renewal reminders run automatically, so an agreement approaching 12 months old arrives as a task rather than a surprise. When a board or a payer asks for proof of monitoring, it is one record, not four folders. Every Pabau subscription includes these tools, so there is no tier to upgrade to first.

Simplify controlled substance agreement management

Store, track, and renew CSAs automatically. Manage patient signatures, monitoring data, and compliance alerts in one integrated system.

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Conclusion

A controlled substance agreement earns its place through the conversation it forces. The patient hears the risks, the monitoring plan, and the consequences before the first prescription, and you hold the record that they did.

Download the form, edit it against your state’s rules, and decide who owns the renewal before the first copy goes out. An agreement that quietly expires does very little for you in an audit.

Book a demo to see how Pabau tracks CSA signatures, renewals, and monitoring inside one patient record.

Continue your research

Screening a patient before starting opioid therapy? The opioid risk tool (ORT) gives providers a validated scoring method to assess misuse risk before the first controlled substance prescription.

Managing a patient’s broader chronic pain plan? A pain management treatment plan template helps document the therapy goals and modalities that a controlled substance agreement sits alongside.

Did a drug screen come back positive? A substance abuse treatment plan gives you a documented next step instead of an abrupt discharge.

Frequently asked questions