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(1) whose Drug Enforcement Administration number has ever been revoked;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 20190HB1214PN1816 - 4 - 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 20190HB1214PN1816 - 5 - 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 20190HB1214PN1816 - 6 - 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 20190HB1214PN1816 - 7 - 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 20190HB1214PN1816 - 8 - 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.

20190HB1214PN1816 - 9 - (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 20190HB1214PN1816 - 10 - second or subsequent offense.

Section 2.

This act shall take effect in 60 days.

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