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Opioid Treatment Agreements: PA Dept. of Health Publishes Temporary Regulations

On March 7, 2020, the Pennsylvania Department of Health (DOH) published new temporary regulations implementing SB 572 - Opioid Treatment Agreements.[1]  In accordance with SB 572, the new temporary regulations require all opioid prescribers to educate their patients on the use of opioids prior to issuing the first prescription in a single course of treatment for chronic pain and both parties must sign an opioid treatment agreement.  In addition to these general requirements, patients may also be required to undergo baseline, periodic, or targeted testing to monitor adherence to medication and detect the use of non-prescribed drugs.

The temporary regulations also require that all opioid treatment agreements:

  1. Identify the goals of treatment;
  2. Contain the patient’s consent to targeted drug testing in circumstances when the provider determines a targeted test is medically necessary;
  3. Set forth the prescribing policies of the prescriber including requirements:
    1. The patient take the prescription as prescribed, and
    2. The patient refrain from sharing the prescribed medication with other individuals.
  4. Require the patient to inform the prescriber about any other controlled substances they are taking;
  5. Explain any reason why opioid therapy may be changed or discontinued by the prescriber;
  6. Identify appropriate disposal methods of opioids no longer being used by the patient (as specified in a consultation with the prescriber);
  7. Identify the brand or generic name, quantity, and initial dosage of the opioid being prescribed;
  8. Contain a statement indicating a controlled substance is a drug or other substance the U.S. Drug Enforce Administration (DEA) has identified as having a potential for abuse;
  9. Contain a statement certifying the provider engaged in a discussion educating the patient about the risks of overdose, increased risks of addiction, the dangers of taking controlled substances; and other information deemed appropriate by the prescriber; and
  10. Be signed and dated by the patient. 

Penalties for failing to comply with the new regulation may subject the prescriber to sanctions under the prescriber’s professional practice act and licensing board. Similarly, where a provider is subjected to discipline by their respective licensing board, the provider may also be subject to civil fines and possible suspension, restriction, or revocation of their license.

If you or your organization may be impacted by the new temporary regulations governing opioid treatment agreements or wish to learn more about how you can comply with the temporary regulations, please contact your Dinsmore attorney. 

 


[1] See, 28 Pa. Code § 26.1, et seq.

© 2022 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume X, Number 72
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About this Author

Brian Murray, healthcare lawyer, Dinsmore
Associate

Bryan focuses his practice on health care law and provides legal counsel to health care industry clients on a range of issues, such as specialty and mail-order pharmacy operations, provider networks and reimbursement, regulatory compliance, contract review and preparation and 340B programming. He has experience analyzing pharmaceutical trade issues affected by state and federal regulatory frameworks, including pharmacy practice acts, the anti-Kickback Statute, the Drug Supply Chain Security Act, the Stark Law and the Health Insurance Probability and Accountability Act. ...

(412) 339-5603
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