PRINTER'S NO. 472
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
428
Session of
2017
INTRODUCED BY BARTOLOTTA, SCARNATI, GREENLEAF, VULAKOVICH,
COSTA, RAFFERTY, WARD, BREWSTER AND BROOKS, MARCH 2, 2017
REFERRED TO HEALTH AND HUMAN SERVICES, MARCH 2, 2017
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, providing for patient-centered opioid
treatment certification.
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
PATIENT-CENTERED OPIOID TREATMENT CERTIFICATION
Sec.
52B01. Definitions.
52B02. Certification.
52B03. Penalties.
52B04. Temporary regulations.
§ 52B01. Definitions.
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:
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"Abstinence-based treatment." Treatment for opioid
dependence that includes 12-step programs, faith-based programs
or treatment in any of the following settings:
(1) Therapeutic community.
(2) Residential.
(3) Intensive outpatient.
(4) Partial hospitalization.
(5) Outpatient.
"Department." The Department of Human Services of the
Commonwealth.
"FDA." The United States Food and Drug Administration.
"Medicaid program." The medical assistance program
established under Title XIX of the Social Security Act (49 Stat.
620, 42 U.S.C. § 1396 et seq.).
"Office-based opioid treatment." Treatment for opioid
dependence using a Schedule III, IV or V controlled substance
narcotic, including a partial opioid agonist, offered in a
primary care setting.
"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 agonist treatment
medications to provide treatment, support and recovery to
opioid-addicted patients.
"Secretary." The Secretary of Human Services.
§ 52B02. Certification.
(a) Establishment.--The department shall establish a program
for the certification of office-based opioid treatment
providers, opioid treatment providers and abstinence-based
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treatment providers. Within six months of the effective date of
this chapter, each office-based opioid treatment provider,
opioid treatment provider and abstinence-based treatment
provider must be certified under this chapter.
(b) Opioid treatment providers and office-based opioid
treatment providers.--Each opioid treatment provider and office-
based opioid treatment provider shall do all of the following:
(1) Establish treatment protocols consistent with
section 303 of the Controlled Substances Act (Public Law 91-
513, 84 Stat. 1236).
(2) Establish standard medical practices in opioid
treatment that require all of the following:
(i) Periodic review of the patient's treatment plan
with the patient to consider changing the plan with the
goal of requiring a minimally clinically necessary
medication dose and the possibility of opioid abstinence.
(ii) Appropriate use of overdose reversal, relapse
prevention, counseling and other services.
(iii) Training and experience requirements for
providers who treat and manage opiate dependent patients,
including training on how to reduce drug abuse and
diversion, and requiring a plan to handle abuse and
diversion through proper education.
(iv) Periodic review of the prescription drug
monitoring program for the patient.
(v) 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
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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) Conduct random pill counts.
(7) Develop an abuse and diversi on plan.
(8) Be credentialed with the Medicaid program.
(9) Receive training on all FDA-approved drugs for the
treatment of opioid addiction, including opioid maintenance
therapy, detoxification, ambulatory outpatient
detoxification, overdose reversal, relapse prevention and
long-acting, non-narcotic, nonaddictive medication.
(10) Provide copies of the protocols under paragraphs
(1) and (2) to the department.
(c) Abstinence-based treatment providers.--Each abstinence-
based treatment provider shall do all of the following:
(1) Receive training on all FDA-approved drugs for the
treatment of opioid dependence.
(2) Require informed consent from a patient concerning
all available FDA-approved drugs for the treatment of opioid
dependence.
(3) Provide all FDA-approved drugs for the treatment of
opioid dependence either directly or by referral.
§ 52B03. Penalties.
(a) Administrative penalty.--A health care provider or
health care facility that fails to comply with rules or
regulations of the department promulgated under this chapter
shall be subject to an administrative fine of $10,000.
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(b) Licensing boards.--Notwithstanding any other provision
of law, a licensing board may limit, condition or suspend the
license of or assess a fine against a health care provider or
health care facility who recklessly or negligently fails to
comply with this chapter or any rules or regulations of the
department promulgated under this chapter.
§ 52B04. 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 their publication.
(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) Sections 204(b) and 301(10) 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 immediately.
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