PRINTER'S NO. 147
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
191
Session of
2019
INTRODUCED BY BARTOLOTTA, BREWSTER, YAW, J. WARD, SCARNATI,
COLLETT, K. WARD AND BROOKS, FEBRUARY 1, 2019
REFERRED TO HEALTH AND HUMAN SERVICES, FEBRUARY 1, 2019
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, providing for office-based opioid and
non-narcotic opioid treatment provider certification; and
establishing the Opioid Treatment Certification Fund.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding a chapter to read:
CHAPTER 52B
OFFICE-BASED OPIOID AND NON-NARCOTIC OPIOID
TREATMENT PROVIDER CERTIFICATION
Sec.
52B01. Definitions.
52B02. Certification.
52B03. Enforcement.
52B04. Fees.
52B05. Opioid Treatment Certification Fund.
52B06. Regulations.
§ 52B01. Definitions.
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The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Department." The Department of Drug and Alcohol Programs of
the Commonwealth.
"FDA." The United States Food and Drug Administration.
"Non-narcotic opioid treatment." Treatment for opioid
dependence using an FDA-approved drug, including a full opioid
antagonist, offered in a primary care setting. The term does not
include office-based opioid treatment.
"Non-narcotic opioid treatment provider." A health care
practitioner as defined in section 103 of the act of July 19,
1979 (P.L.130, No.48), known as the Health Care Facilities Act,
who provides non-narcotic opioid treatment to at least 100
opioid-addicted patients over an aggregate period.
"Office-based opioid treatment." Treatment for opioid
dependence using a Schedule III, IV or V controlled substance
narcotic, including a partial opioid antagonist, offered in a
primary care setting.
"Office-based opioid treatment provider." A health care
practitioner as defined in section 103 of the Health Care
Facilities Act, who is permitted to provide office-based opioid
treatment under 21 U.S.C. § 823(g)(2)(A) (relating to
registration requirements) to at least 100 opioid-addicted
patients over an aggregate period.
"Opioid." As defined in section 5202 (relating to
definitions).
"Opioid treatment." Treatment provided at a health care
facility as defined in section 5202 that uses pharmacological
interventions, including full opiate antagonist medications to
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provide treatment, support and recovery to opioid-addicted
patients.
§ 52B02. Certification.
(a) Establishment.--The department shall establish a program
for the certification of office-based opioid treatment providers
and non-narcotic opioid treatment providers. Within one year of
the effective date of this chapter, each office-based opioid
treatment provider and non-narcotic opioid treatment provider
must be certified under this chapter.
(b) Renewal.--Office-based opioid treatment providers and
non-narcotic opioid treatment providers shall be required to
obtain the certifications required by this chapter every 36
months.
(c) Additional requirements.--In addition to department-
established requirements promulgated under section 52B06
(relating to regulations), each office-based opioid treatment
provider and non-narcotic opioid treatment provider shall do all
of the following:
(1) Follow department-established treatment protocols
consistent with section 303 of the Controlled Substances Act
(Public Law 91-513, 84 Stat. 1236).
(2) Follow standard medical practices in opioid
treatment that require all of the following:
(i) Appropriate use of overdose reversal, relapse
prevention, counseling and other services.
(ii) Require training and experience for qualifying
practitioners as that term is defined under 21 U.S.C. §
823(g)(2)(G)(iii) (relating to registration
requirements), who treat and manage opiate dependent
patients, including training on how to reduce drug abuse
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and diversion, and requiring a plan to handle drug abuse
and diversion through proper education.
(iii) Review the prescription drug monitoring
program, including the requirements for prescribers and
training under sections 8 and 9.1 of 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.
(iv) Obtain informed consent from a patient
concerning all available FDA-approved opioid treatment
drug options, including each option's risks and benefits
before being prescribed.
(3) Develop an individualized treatment plan for each
patient, which must be signed by the patient.
(4) Require each patient to actively participate in
appropriate behavioral counseling or treatment for the
patient's substance abuse and document each visit that the
patient is attending sufficient behavioral health treatment.
(5) Provide ongoing toxicological testing.
(6) Develop a drug abuse and diversion plan.
(7) Physically secure and maintain the confidentiality
of all patient records in accordance with 42 CFR 2.22
(relating to notice to patients of federal confidentiality
requirements) and 28 Pa. Code § 709.28 (relating to
confidentiality). Patient records, regardless of format,
shall be readily accessible for a minimum of four years
following the discharge of a patient.
§ 52B03. Enforcement.
(a) Powers of department.--If the department determines that
an office-based opioid treatment provider or non-narcotic opioid
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treatment provider or primary care facility has violated any
provision of this chapter or department regulation, the
department may:
(1) Direct the office-based opioid treatment provider or
non-narcotic opioid treatment provider to implement a
corrective action plan.
(2) Deny, suspend, revoke or refuse to renew the
certification of an office-based opioid treatment provider or
non-narcotic opioid treatment provider.
(3) Impose a monetary penalty up to $5,000 per
violation.
(4) Impose other conditions and penalties as deemed
appropriate.
(b) Licensing boards.--An office-based opioid treatment
provider or non-narcotic opioid treatment provider violating
provisions of this chapter shall also be subject to sanctions
under the provider's professional practice act and by the
appropriate licensing board.
§ 52B04. Fees.
The department shall, by regulation, set fees for
applications for certification and certification renewals.
§ 52B05. Opioid Treatment Certification Fund.
(a) Establishment.--The Opioid Treatment Certification Fund
is established in the State Treasury. Money in the fund shall be
used for the implementation and administration of this chapter.
(b) Deposit.--All penalties and fees collected under this
chapter shall be deposited into the Opioid Treatment
Certification Fund.
§ 52B06. Regulations.
(a) Authorization.--The department, in consultation with the
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Department of Health, is authorized to promulgate regulations to
implement and administer the certification and certification
renewals of office-based opioid treatment providers and non-
narcotic opioid treatment providers.
(b) Temporary regulations.--In order to facilitate the
prompt implementation of this chapter, the department may issue
temporary regulations. The following shall apply:
(1) The temporary regulations shall expire no later than
two years after publication of the temporary regulations.
(2) The temporary regulations issued by the department
shall not be subject to:
(i) Sections 201, 202, 203, 204 and 205 of the act
of July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(ii) Section 204(b) of the act of October 15, 1980
(P.L.950, No.164), known as the Commonwealth Attorneys
Act.
(iii) The act of June 25, 1982 (P.L.633, No.181),
known as the Regulatory Review Act.
Section 2. This act shall take effect in 180 days.
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