RULES AND REGULATIONS
Title 28—HEALTH AND SAFETY
DEPARTMENT OF HEALTH
[ 28 PA. CODE CH. 26 ]
Opioid Treatment Agreements; Temporary Regulations
[50 Pa.B. 1352]
[Saturday, March 7, 2020]
The Department of Health (Department) is publishing temporary regulations regarding the Opioid Treatment Agreements. Authority to promulgate these temporary regulations is found in section 52B03 of the act of November 27, 2019 (P.L. 764, No. 112) (Act 112). The authority granted to the Department under section 52B03 provides for the Department to promulgate temporary regulations within 90 days of the effective date of Act 112. Section 52B03 further provides that the temporary regulations are not subject to sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201—1205), known as the Commonwealth Documents Law, the Regulatory Review Act (71 P.S. §§ 745.1—745.14) and sections 204(b) and 301(10) of the Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)).
The Department engaged various stakeholders in the drafting of these temporary regulations prior to their submission and received various helpful comments. One such comment questioned the use of urine testing (which is the only testing that is specifically mentioned under Act 112). The commenter raised the issue that some individuals cannot produce urine for drug testing and questioned whether other types of drug tests were permissible. As a result of this comment, the Department will allow for other drug testing only when a patient, out of medical necessity, cannot produce urine for drug testing. The Department believes that allowing the exception for other drug tests under this limited and rare circumstance is reasonable and within the parameters of Act 112. Therefore, in these temporary regulations, the Department has added a provision in subsection 26.4(h) addressing this issue.
The Department made a few other changes in the regulations as well. The Department clarified the definition of ''individual'' to mean a natural person who is at least 18 years of age. The Department added the definition for ''prescription'' or ''prescription order'' as defined in section 2 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. § 780-102). This addition was a result of comments received that requested clarification as to what exactly constituted a prescription, as differentiated from direct administration of a drug, since that term is used in the statute but was not defined. Section 26.4(a)(3) of the temporary regulations sets forth the items which must be included in an opioid treatment agreement. This regulatory section combines the requirements of section 52B02(a)(3) and (b) of the act so that all requirements are located in one place. The Department added a provision regarding the termination of Opioid Treatment Agreements based on comments received. Commenters requested detail regarding when they may terminate Opioid Treatment Agreements. Finally, the Department added a provision regarding its role in enforcement. Section 26.5(b) was added based on questions from commenters as to when and how the Department would enforce Act 112. Since the Department has no enforcement authority and all enforcement is delegated to the appropriate licensing boards, the Department will refer any known complaints to those boards.
In drafting these temporary regulations, the Department reached out to stakeholders affected by Act 112. Pennsylvania Osteopathic Medical Association, Pennsylvania Medical Society, Pennsylvania Coalition of Nurse Practitioners, the Pennsylvania Society of Physician Assistants, the Achieving Better Care by Monitoring All Prescriptions Advisory Committee, the Hospital and Healthsystem of Pennsylvania, and the Safe and Effective Opioid Prescribing Practices Task Force were engaged in the drafting of these temporary regulations and were provided an opportunity to comment. All comments were considered and, where appropriate, the temporary regulations were modified in response to comments received. Following implementation, if further guidance is necessary, the Department may address other comments by means of a ''Frequently Asked Questions'' page published on the Department's web site.
For additional information or persons with a disability who require an alternative format of this document (for example, large print, audiotape, Braille) contact Peter Blank, Executive Policy Specialist, Department of Health, Harrisburg, PA at (717) 547-3454, or for speech and/or hearing impaired persons, call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
RACHEL L. LEVINE, MD,
(Editor's Note: Title 28 of the Pennsylvania Code is amended by adding temporary regulations in §§ 26.1—26.5 as set forth in Annex A.)
Fiscal Note: 10-220. No fiscal impact; (8) recommends adoption.
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 26. OPIOID TREATMENT AGREEMENTS—TEMPORARY REGULATIONS
26.1. Purpose. 26.2. Legal basis. 26.3. Definitions. 26.4. Procedures. 26.5. Penalties.
§ 26.1. Purpose.
This chapter provides for the regulation of Opioid Treatment Agreements for those prescribers and individuals who are required to enter into these agreements when opioids are prescribed for the treatment of chronic pain.
§ 26.2. Legal basis.
(a) This chapter is promulgated by the Department under the powers granted and the duties mandated by section 52B03 of the act of November 27, 2019 (P.L. 764, No. 112) (Act 112).
(b) The Department has the power to promulgate temporary regulations within 90 days of the effective date of Act 112. The temporary regulations shall not be subject to:
(1) Sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240), known as the Commonwealth Documents Law.
(2) Sections 204(b) and 301(10) of the act of October 15, 1980 (P.L. 950, No. 164), known as the Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)).
(3) The act of June 25, 1982 (P.L. 633, No. 181) (71 P.S. §§ 745.1—745.14) known as the Regulatory Review Act.
§ 26.3. Definitions.
The following words and phrases when used in this chapter have the following meanings unless the context clearly indicates otherwise:
Acute pain—Pain that comes on quickly, may be severe, but lasts a relatively short time and is provoked by a specific condition or injury.
Baseline test—The initial assessment through a urine drug test to:
(1) identify the presence of an illegal substance prior to prescribing a controlled substance; or
(2) assess the presence or absence of a prescribed drug or drug class.
Chronic pain—Pain that persists or progresses over a period of time that may be related to another medical condition and is resistant to medical treatment. The term does not include acute pain.
Controlled substance—A drug, substance or immediate precursor included in Schedules II—V of section 4 of the act of April 14, 1972 (P.L. 233, No. 64) (35 P.S. §§ 780-101—780-144), known as The Controlled Substance, Drug, Device and Cosmetic Act.
Definitive drug test—A qualitative or quantitative urine drug test used to identify specific drugs, specific drug concentrations and associated metabolites.
Department—The Department of Health of the Commonwealth.
Individual—A natural person who is at least 18 years of age.
Medical emergency—A situation that, in the good faith professional judgment of the prescriber, creates a time sensitive threat of serious risk to the life or physical health of a person. The term includes treatment received in an emergency department or urgent care center under the act of November 2, 2016 (P.L. 976, No. 122), known as the Safe Emergency Prescribing Act (35 P.S. §§ 873.1—873.9).
Opioid—Any of the following:
(1) A preparation or derivative of opium.
(2) A synthetic narcotic that has opiate-like effects but is not derived from opium.
(3) A group of naturally occurring peptides that bind at or otherwise influence opiate receptors, including an opioid agonist.
Periodic test—A urine drug test that screens for a selection of drugs.
Prescriber—As defined in the act of October 27, 2014 (P.L. 2911, No. 191), known as the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act (35 P.S. §§ 872.1—872.40).
Prescription or prescription order—A written, oral or electronic order for a controlled substance, other drug or medication, or device for medication which is dispensed to or for an ultimate user but does not include an order for a controlled substance, other drug or medication, or device for medication which is dispensed for immediate administration to the ultimate user.
Presumptive positive drug test—A urine drug test that is used to identify suspected possible use or nonuse of drugs or a drug class that may be followed by a definitive test to specifically identify drugs or metabolites.
Targeted test—A urine drug test ordered at the discretion of a prescriber, based on observation of the prescriber and related circumstances that enhance clinical decision making.
Treatment agreement—A document signed by a prescriber and individual that contains a statement to ensure that the individual understands:
(1) Treatment responsibilities.
(2) The conditions of medication use.
(3) The conditions under which the treatment of the individual may be terminated.
(4) The responsibilities of the prescriber.
§ 26.4. Procedures.
(a) Prescriber requirements. Except as specified in subsection (c), before issuing an individual the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid, regardless of whether the dosage is modified during that course of treatment, a prescriber shall:
(1) Assess whether the individual has taken or is currently taking a prescription drug for treatment of a substance use disorder.
(2) Discuss with the individual:
(i) The risks of addiction and overdose associated with the controlled substance containing an opioid.
(ii) The increased risk of addiction to a controlled substance if the individual suffers from a mental disorder or substance use disorder.
(iii) The dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants.
(iv) Other information deemed appropriate by the prescriber under 21 CFR 201.57(c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1)).
(v) The nonopioid treatment options available for treating chronic noncancer pain, if applicable, that are consistent with the best practices per the Pennsylvania Opioid Prescribing Guidelines.
(3) Review and sign a treatment agreement form that includes:
(i) The goals of the treatment.
(ii) The consent of the individual to a targeted test in a circumstance where the physician or prescriber determines that a targeted test is medically necessary. The treatment of chronic pain shall be consistent with the Pennsylvania Opioid Prescribing Guidelines.
(iii) The prescription drug prescribing policies of the prescriber, which policies include:
(A) A requirement that the individual take the medication as prescribed.
(B) A prohibition on sharing the prescribed medication with other individuals.
(iv) A requirement that the individual inform the prescriber about any other controlled substances prescribed or taken by the individual.
(v) Any reason why the opioid therapy may be changed or discontinued by the prescriber.
(vi) Appropriate disposal methods for opioids that are no longer being used by the individual as specified in a consultation with the prescriber.
(vii) The brand name or generic name, quantity and initial dose of the controlled substance containing an opioid being prescribed.
(viii) A statement indicating that a controlled substance is a drug or other substance that the United States Drug Enforcement Administration has identified as having a potential for abuse.
(ix) A statement certifying that the prescriber engaged in the discussion under subsection (a)(2).
(x) The signature of the individual and the date of signing. The prescriber may utilize electronic methods to obtain the signature of the individual and the date of signing.
(4) Obtain written consent for the prescription from the individual. The prescriber may utilize electronic methods to obtain the written consent of the individual.
(5) Record the consent under subsection (a)(4) on the treatment agreement form in subsection (a)(3).
(b) The treatment agreement form under subsection (a)(3) shall be maintained by the prescriber in the medical record of the individual.
(c) Urine drug testing.
(1) A baseline test, periodic test or targeted test shall be used to establish a general assessment for an individual new to treatment for chronic pain and in monitoring adherence to an existing individual treatment plan, as well as to detect the use of a nonprescribed drug.
(2) A baseline test shall be required prior to the issuance of the initial prescription for chronic pain and shall include confirmatory or quantitative testing of presumptive positive drug test results.
(3) An individual who is treated for addiction or an individual who is considered moderate or high risk by the prescriber shall be tested at least once annually or as frequently as necessary to ensure therapeutic adherence.
(d) Exception. Subsection (c) shall not apply if the treatment of an individual with a controlled substance containing an opioid is associated with or incident to:
(1) A medical emergency documented in the medical record of the individual.
(2) The management of pain associated with cancer.
(3) The use in palliative or hospice care.
(4) The professional judgment of the prescriber under subsections (a)(1) and (2).
(e) Documentation of exception. If subsection (d) applies, the prescriber shall document in the individual's medical record the factor under subsection (d) that the prescriber believes applies to the individual.
(f) A prescriber may terminate the treatment agreement form under subsection (a)(3) if the prescriber has reasonable belief, based on standards of professional practice, that the treatment agreement is no longer necessary.
(g) If a prescriber terminates a treatment agreement under subsection (f), the prescriber shall:
(1) Document the reason for the termination of the treatment agreement in the individual's medical record.
(2) Inform the individual of the termination of the treatment agreement.
(3) If necessary, work with the individual, to the fullest extent possible, to ensure continuity of care as outlined under 49 Pa. Code § 16.61(a)(17) (relating to unprofessional and immoral conduct).
(h) Urine testing exception. If, because of a medical necessity, an individual is unable to produce urine for the urine drug testing required herein, a different type of drug test may be used that is at least equivalent in accuracy to a urine drug test approved by the Food and Drug Administration. Alternative drug tests may not be substituted for urine drug tests under any other circumstances.
§ 26.5. Penalties.
(a) A violation of this chapter by a prescriber shall be subject to sanctions under the prescriber's professional practice act and by the appropriate licensing board.
(b) The Department will refer a complaint of a violation of this chapter, if known to the Department, to the appropriate licensing board for sanctions under subsection (a).
[Pa.B. Doc. No. 20-320. Filed for public inspection March 6, 2020, 9:00 a.m.]
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