Evidence status: CURRENT STATUTORY AND REGULATORY TESTING FRAMEWORK. Pennsylvania Act 112 and 28 Pa. Code Chapter 26 add urine-drug-testing requirements to covered chronic-pain opioid treatment.
Baseline testing
A baseline urine drug test is required before the initial opioid prescription for chronic pain and must include confirmatory or quantitative testing of presumptive positive results.
Periodic and targeted testing
The statutory framework recognizes baseline, periodic, and targeted testing to assess adherence and detect nonprescribed drug use. The treatment agreement itself must include patient consent to targeted testing when the prescriber determines such testing is medically necessary.
Annual minimum for higher-risk patients
An individual receiving addiction treatment or considered moderate or high risk by the prescriber must be tested at least annually, or more often as necessary to ensure therapeutic adherence.
Testing exceptions
The urine-testing requirement does not apply when opioid treatment is associated with:
- A documented medical emergency.
- Pain associated with cancer.
- Palliative or hospice care.
- The prescriber’s professional judgment under the required substance-use assessment and counseling provisions.
The prescriber must document the applicable exception in the medical record.
Alternative specimen testing
If medical necessity prevents the patient from producing urine, the temporary regulation allows an alternative drug test that is at least equivalent in accuracy to an FDA-approved urine drug test. Alternative tests are not authorized merely for convenience.
Important distinction
Pennsylvania’s Department of Health guidance emphasizes that Act 112 does not require limiting a patient to one pharmacy and does not require a targeted blood test. Those are not statewide Act 112 minimums.
Primary sources
Reviewed: October 4, 2026.