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A01362
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1214
Session of
2019
INTRODUCED BY STRUZZI, TOEPEL, MOUL, SCHMITT, SCHLEGEL CULVER,
MILLARD, DeLUCA, ZABEL, IRVIN, MACKENZIE, ZIMMERMAN,
PASHINSKI AND CIRESI, APRIL 15, 2019
REFERRED TO COMMITTEE ON HEALTH, APRIL 15, 2019
AN ACT
Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An
act relating to health care; prescribing the powers and
duties of the Department of Health; establishing and
providing the powers and duties of the State Health
Coordinating Council, health systems agencies and Health Care
Policy Board in the Department of Health, and State Health
Facility Hearing Board in the Department of Justice;
providing for certification of need of health care providers
and prescribing penalties," providing for pain management
clinics; and imposing penalties.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The act of July 19, 1979 (P.L.130, No.48), known
as the Health Care Facilities Act, is amended by adding a
chapter to read:
CHAPTER 8-A
PAIN MANAGEMENT CLINICS
Section 801-A. 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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"Controlled substance." A drug, substance or immediate
precursor included in Schedules I through V of the act of April
14, 1972 (P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
"Pain management clinic." A facility that advertises in any
medium for a type of pain service and where, in any calendar
month, a majority of patients of the prescribers at the facility
are provided treatment for pain that includes the use of
controlled substances. The term does not include the following
facilities that are otherwise licensed under Chapter 8:
(1) A hospital, including a licensed facility or
facility owned by the hospital, including any outpatient
facility or clinic of the hospital included in the hospital
license.
(2) A hospice program or residential hospice facility.
(3) An ambulatory surgical center.
(4) A long-term care nursing facility.
(5) A home health care agency or home health care
facility.
(6) A birth center. The term does not include a facility
that is otherwise licensed as a health care facility under
Chapter 8.
"Physician." A person who possesses a current license to
practice medicine in this Commonwealth who has not been denied
the privilege of prescribing, dispensing, administering,
supplying or selling any controlled substance.
"Prescriber." A person who is licensed, registered or
otherwise lawfully authorized to distribute, dispense or
administer a controlled substance, other drug or device in the
course of professional practice or research in this
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Commonwealth.
"Prescription Drug Monitoring Program." The Achieving Better
Care by Monitoring All Prescriptions Program (ABC-MAP) as
established under 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.
Section 802-A. Registration.
( a) Duty to register.--
(1) Each pain management clinic shall register and
maintain a valid registration with the department.
(2) A facility shall register within 30 days following
the conclusion of the month in which the facility meets the
definition of pain management clinic under this chapter.
(3) Each pain management clinic location shall be
registered separately.
(4) Any change in ownership of a pain management clinic
shall require a new registration application.
(5) The registration and renewal fee shall be
established by the department and shall be paid upon change
of physical location or change of ownership.
(b) Required information.--Each pain management clinic shall
provide to the department, as part of its registration, the
following information in writing:
(1) The name, business address, profession, current
professional licensing status and nature and extent of
ownership or investment interest of each person who has or
maintains an ownership or investment interest in the pain
management clinic.
(2) The names and addresses of each pain management
clinic in which the person has an ownership or investment
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interest.
(3) The hours of operation of each pain management
clinic in which the person has an ownership or investment
interest.
(4) The names and professional status of each health
care practitioner at each practice location owned and
operated by that pain management clinic.
(5) The name, professional license number and practice
address of the owner or medical director who will be
physically present in the pain management clinic for at least
50% of the time patients are present in the clinic. The pain
management clinic shall also state its plan for ensuring that
the designated owner or medical director will be physically
present in the facility.
(c) Duration of registration.--Each registration shall be
valid for 365 days.
(d) Reasons to deny registration.--The department shall deny
registration to a pain management clinic owned by or with any
contractual or employment relationship with a physician:
(1) whose Drug Enforcement Administration number has
ever been revoked;
(2) whose application for a license to prescribe,
dispense or administer a controlled substance has been denied
by any jurisdiction; or
(3) who has been convicted of or pleaded guilty or nolo
contendere to an offense that constitutes a felony under the
act of April 14, 1972 (P.L.233, No.64), known as The
Controlled Substance, Drug, Device and Cosmetic Act, or an
equivalent offense under the laws of the United States or one
of its territories or possessions, another state, the
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District of Columbia, the Commonwealth of Puerto Rico or a
foreign nation.
(e) Revocation or nonrenewal of registration.--A pain
management clinic shall be subject to the revocation and
nonrenewal of license provisions under section 811. In addition,
the following shall apply:
(1) If the department finds that a pain management
clinic is owned or operated by a person meeting any criteria
listed in subsection (d), the department shall revoke the
clinic's certificate of registration.
(2) If the registration of a pain management clinic is
revoked or suspended, no individual shall operate the
facility as a pain management clinic as of the effective date
of the suspension or revocation.
Section 803-A. Ownership.
(a) General rule.--Only a physician having a valid and
active license to practice medicine or osteopathy in this
Commonwealth may have an ownership or investment interest in a
pain management clinic.
(b) Subspecialty certification required.--At least one of a
clinic's owners must hold a valid and active subspecialty
certification from a nationally recognized board in pain
management or pain medicine.
Section 804-A. Medical director.
(a) General rule.--A pain management clinic shall designate
a physician to be the clinic medical director who shall oversee
and ensure the pain management clinic's compliance with the
registration and operational requirements.
(b) When physical presence required.--At least one clinic
owner or medical director must be physically present at least
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50% of the time patients are present at the clinic and must hold
a valid and active subspecialty certification from a nationally
recognized board in pain management.
(c) Duties.--
(1) The medical director shall ensure compliance with
the quality assurance requirements promulgated by the
department.
(2) The medical director shall establish an ongoing
quality assurance program that objectively and systematically
monitors and evaluates the quality and appropriateness of
patient care.
Section 805-A. Prescribing.
(a) General rule.--Each prescriber who prescribes controlled
substances to patients, as part of employment at a pain
management clinic, shall hold an appropriate license,
registration or certification at the time of prescribing.
(b) Prohibition.--No physician, prescriber or other person
working at a pain management clinic is permitted to dispense
controlled substances at the clinic.
(c) Physical examinations.--A physician or health care
practitioner shall perform a physical examination of a patient
on the same day a prescriber prescribes a controlled substance
to the patient at a pain management clinic.
(d) Duty to access prescription drug monitoring program.--A
physician shall access the prescription drug monitoring program
prior to prescribing a controlled substance in order to
determine the patient's controlled substance history.
Section 806-A. Reporting and recordkeeping.
(a) General rule.--On a quarterly basis the medical director
of a pain management clinic shall submit to the department the
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number of new and repeat patients seen and treated at the pain
management clinic who are prescribed controlled substance
medications for the treatment of chronic, nonmalignant pain.
(b) Documentation required.--Each pain management clinic
shall document on a monthly basis that the designated owner or
medical director was physically present for at least 50% of the
time patients were present. This documentation shall include:
(1) The name, practice address and telephone number of
the physician owner or medical director who fulfilled this
oversight function for that specific week.
(2) The address of each practice location owned and
operated by the pain management clinic.
(3) The days and hours each practice location of the
pain management clinic was open to patients during that
specific week.
(4) The days and hours the physician owner or medical
director was present in each practice location for the pain
management clinic for that specific week.
(c) Retention period.--The records shall be maintained by
the pain management clinic for a minimum period of seven years.
Section 807-A. Physical environment.
A pain management clinic shall be located and operated at a
publicly accessible, fixed location and shall:
(1) Comply with building codes, ordinances and
administrative regulations that are enforced by State and
municipal jurisdictions.
(2) Display a sign that can be viewed by the public that
contains the clinic's name, hours of operation and street
address.
(3) Have a publicly listed telephone number and
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dedicated, operational telephone number.
(4) Have emergency lighting.
(5) Have a reception and waiting area.
(6) Provide a restroom.
(7) Have an administrative area, including room for
storage of medical records, supplies and equipment.
(8) Have private patient examination rooms.
(9) Have treatment rooms, if treatment is being provided
to patients.
(10) Display a printed sign located in a conspicuous
place in the waiting room viewable by the public with the
name and contact information of the clinic's medical director
and the names of all physicians and prescribers practicing in
the clinic.
(11) Have infection control policies.
Section 808-A. Regulations.
The department shall promulgate rules in accordance with the
provisions of this section for the registration of pain
management clinics to ensure adequate care, treatment, health,
safety, welfare and comfort of patients. The rules shall
include, at a minimum:
(1) The process to be followed by applicants seeking
registration.
(2) The qualifications and supervision of registered and
nonregistered personnel at pain management clinics and
training requirements for all clinic health care
practitioners.
(3) The provision and coordination of patient care,
including the development of a written plan of care.
(4) The management, operation, staffing and equipping of
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the pain management clinic.
(5) The clinical, medical, patient and business records
to be kept by the pain management clinic.
(6) The procedures for inspections and for the review of
utilization and quality of patient care.
(7) The standards and procedures for the general
operation of a pain management clinic, including facility
operations, physical operations, infection control
requirements, health and safety requirements and quality
assurance.
(8) Identification of drugs that may be used to treat
chronic pain that identify a facility as a pain management
clinic, including, at a minimum, tramadol and carisoprodol.
(9) Any other criteria that identify a facility as a
pain management clinic.
(10) The standards and procedures to be followed by an
owner in providing supervision, direction and control of
individuals employed by or associated with a pain management
clinic.
(11) Data collection and reporting requirements.
(12) Such other standards or requirements as the
Secretary of Health determines are appropriate.
Section 809-A. Inspections.
(a) Duty to conduct.--The department shall conduct at least
one announced and one unannounced inspection of the pain
management clinic no less than annually, including a review of
patient records to ensure that a pain management clinic complies
with the provisions of this chapter. A representative from the
department shall have access to a pain management clinic and its
records.
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(b) Inspection fee.--An inspection fee as set by the
department shall be paid annually for each location required to
be inspected.
Section 810-A. Violations.
(a) General rule.--When appropriate, the department shall
work with a pain management clinic to rectify a violation of
this section.
(b) Specific sanctions.--A pain management clinic that
violates this chapter may be subject to sanctions by the
department, which may include the following:
(1) Suspension of its registration.
(2) Revocation of its registration.
(3) Refusal to renew its registration.
(4) Issuance of a provisional license.
(5) Submission of a plan of correction.
(6) Prohibition of all physicians from practicing at
that, or any other, pain management clinic.
(7) Any other sanction deemed necessary by the
department.
(c) Civil penalty.--A person who violates this section may
be subject to a civil penalty, not to exceed $500 per day.
Section 811-A. Criminal penalty.
(a) Offense defined.--A person who knowingly operates, owns
or manages a nonregistered pain clinic that is required to be
registered with the department under this chapter commits an
offense.
(b) Grading.--An offense under subsection (a) constitutes a:
(1) Misdemeanor of the first degree, when the offense is
the first offense.
(2) Felony of the third degree, when the offense is a
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second or subsequent offense.
Section 2. This act shall take effect in 60 days.
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