THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

INTRODUCED BY STACK, FONTANA, BREWSTER, RAFFERTY, TARTAGLIONE, BROWNE, KASUNIC, MENSCH AND SOLOBAY, JANUARY 3, 2012

REFERRED TO PUBLIC HEALTH AND WELFARE, JANUARY 3, 2012  

AN ACT

Amending Title 44 (Law and Justice) of the Pennsylvania

Consolidated Statutes, establishing the Pharmaceutical

Accountability Monitoring System; and imposing penalties.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Title 44 of the Pennsylvania Consolidated

Statutes is amended by adding a chapter to read:

CHAPTER 27

PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM

Sec.

2701.  Short title of chapter.

2702.  Purpose.

2703.  Scope of chapter.

2704.  Definitions.

2705.  Advisory committee.

2706.  Establishment of Pharmaceutical Accountability Monitoring

System.

2707.  Requirements for Pharmaceutical Accountability Monitoring

System.

2708.  Access to prescription information.

2709.  Unlawful acts and penalties.

2710.  Education and treatment.

2711.  Immunity.

2712.  Additional provisions.

2713.  Use of money collected.

2714.  Rules and regulations.

2715.  Evaluation, data analysis and reporting.

2716.  Concurrent jurisdiction.

§ 2701.  Short title of chapter.

This chapter shall be known and may be cited as the

Pharmaceutical Accountability Monitoring System Act.

§ 2702.  Purpose.

The purpose of this chapter is to reduce the abuse of

controlled substances and fraud by providing a tool that will

ensure that practitioners making prescribing decisions have

complete and reliable information about what, if any, other

prescription drugs have recently been prescribed to their

patients. It is the purpose of this act to provide reporting

mechanisms, with full confidentiality protections, in which

dispensers report prescription information to a central

repository, in order to identify patient and practitioner

behaviors that give rise to a reasonable suspicion that

prescription drugs are being inappropriately obtained or

prescribed, so that appropriate ameliorative and corrective

action, including treatment for individuals suffering from drug

and alcohol addiction, may be taken. This chapter is further

intended to help detect, refer to law enforcement and regulatory

agencies and deter prescription drug fraud and diversion.

§ 2703.  Scope of chapter.

This chapter is intended to improve the Commonwealth's

ability to enable informed and responsible prescribing and

dispensing of controlled substances and to reduce diversion and

misuse of such drugs in an efficient and cost-effective manner

that will not impede the appropriate medical utilization of

licit controlled substances.

§ 2704.  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:

"Alcohol and other drug addiction treatment program."  Any

facility or treatment program that is licensed by the

Commonwealth to provide alcohol and other drug addiction

treatment on a hospital, nonhospital residential or outpatient

basis.

"Bona fide investigation."  An investigation that is entered

into in good faith against a specific individual and based on

information secured outside of the PAMS except in circumstances

where a person with lawful access to the information contained

in the PAMS brings a report of that information to the attention

of law enforcement.

"Controlled substance."  A drug, substance or immediate

precursor included in Schedule II, III, IV or V of the act of

April 14, 1972 (P.L.233, No.64), known as The Controlled

Substance, Drug, Device and Cosmetic Act, or the Controlled

Substances Act (Public Law 91-513, 84 Stat. 1236).

"Database."  The Pharmaceutical Accountability Monitoring

System established in section 2706 (relating to establishment of

Pharmaceutical Accountability Monitoring System).

"Department."  The Department of Drug and Alcohol Programs.

"Dispense."  To deliver a controlled substance, other drug or

device to an ultimate user by or pursuant to the lawful order of

a practitioner.

"Dispenser."  A practitioner who dispenses in this

Commonwealth, including mail order and Internet sales of

pharmaceuticals. The term does not include any of the following:

(1)  A licensed health care facility or long-term care

pharmacy that distributes such substances for the purpose of

inpatient hospital or long-term care facility administration.

(2)  A practitioner or other authorized person who

administers such a substance.

(3)  A wholesale distributor of a controlled substance.

(4)  A hospice care provider.

(5)  A medical practitioner at a health care facility

licensed by this Commonwealth if the quantity of controlled

substances dispensed is limited to an amount adequate to

treat the patient for a maximum of 24 hours with not more

than two 24-hour cycles within any 15-day period.

"Internet pharmacy."  A person, entity or Internet site,

whether in the United States or abroad, that knowingly or

intentionally delivers, distributes or dispenses, or offers or

attempts to deliver, distribute or dispense, a controlled

substance by means of the Internet, including a pharmacy.

"Licensed health care facility."  A health care facility that

is licensed under Article X of the act of June 13, 1967 (P.L.

31, No.21), known as the Public Welfare Code, or the act of July

19, 1979 (P.L.130, No.48), known as the Health Care Facilities

Act.

"Mail-order pharmacy."  A pharmacy that dispenses controlled

substances using the United States Postal Service or any express

delivery service.

"PAMS."  The Pharmaceutical Accountability Monitoring System

established in section 2706 (relating to establishment of

Pharmaceutical Accountability Monitoring System).

"Practitioner."  The term shall mean:

(1)  a physician, dentist, veterinarian, pharmacist,

podiatrist, physician assistant, certified registered nurse

practitioner or other person licensed, registered or

otherwise permitted to distribute, dispense or to administer

a controlled substance, other drug or device in the course of

professional practice or research in this Commonwealth; or

(2)  a pharmacy, hospital, clinic or other institution

licensed, registered or otherwise permitted to distribute,

dispense, conduct research with respect to or to administer a

controlled substance, other drug or device in the course of

professional practice or research in this Commonwealth.

"Ultimate user."  A person who lawfully possesses a

controlled substance, other drug, device or cosmetic for his own

use or for the use of a member of his household or for

administering to an animal in his care.

§ 2705.  Advisory committee.

(a)  Establishment.--An advisory committee is established to

provide input and advice to the department regarding the

establishment and maintenance of PAMS, including, but not

limited to:

(1)  Use of PAMS to improve patient care, to identify and

address addiction and to facilitate the goal of reducing

misuse, abuse, overdose, addiction to and diversion of

controlled substances and drugs of concern.

(2)  Safeguards for the release of information to

authorized users.

(3)  The confidentiality of prescription monitoring

information and the integrity of the patient's relationship

with the patient's health care provider.

(4)  Development of criteria for referring prescription

monitoring information to a law enforcement or professional

licensing agency.

(5)  Development of criteria for referring a prescriber

or dispenser to a professional licensing agency or impaired

professionals association.

(6)  The design and implementation of training, education

or instruction.

(7)  The provision of assessment and referral to alcohol

and other drug addiction treatment as part of any other

requirements of this chapter.

(8)  Technical standards for electronic reporting of

prescription monitoring information.

(9)  Technological improvements to facilitate the

interoperability of PAMS with other State prescription drug

monitoring programs and electronic health information systems

and to facilitate prescribers' and dispensers' access to and

use of PAMS.

(10)  Proper analysis and interpretation of prescription

monitoring information.

(11)  Design and implementation of an evaluation

component.

(12)  Recommended appointments to the advisory committee.

(b)  Confidentiality.--For the purpose of providing input and

advice pursuant to subsection (a), no advisory committee member

shall receive prescription monitoring information which

identifies, or could reasonably be used to identify, the

patient, prescriber, dispenser or other person who is the

subject of the information.

(c)  Membership.--

(1)  The department shall establish an advisory committee

comprised of the following:

(i)  A representative recommended by the Department

of State representing the State Board of Medicine and the

State Board of Nursing.

(ii)  A representative recommended by the State Board

of Pharmacy.

(iii)  A representative recommended by the Attorney

General.

(iv)  Two physicians recommended by the Pennsylvania

Medical Society, one of whom holds membership in the

American Society of Addiction Medicine and the other who

is a physician with expertise in chronic pain management

and treatment.

(v)  A representative recommended by the Pennsylvania

District Attorneys Association.

(vi)  A representative recommended by the

Pennsylvania Coroners Association.

(vii)  A representative recommended by the Drug and

Alcohol Service Providers Organization of Pennsylvania.

(viii)  A representative of chronic pain patients

recommended by a physician with expertise in chronic pain

management.

(2)  The department may also appoint persons with

recognized expertise, knowledge and experience in the

establishment and maintenance of prescription monitoring

programs, skills and expertise in alcohol and other drug

addiction assessment and referral to addiction treatment or

issues involving the misuse, abuse or diversion of, or the

addiction to, controlled substances or drugs of concern.

(d)  Quorum.--Nine members of the advisory committee shall

constitute a quorum for the transaction of all business. The

members shall elect a chairman and such other officers as deemed

necessary whose duties shall be established by the advisory

committee. The department shall convene the advisory committee

at least quarterly using telecommunication whenever possible.

(e)  Staff assistance.--The department shall provide the

advisory committee with any staff services which may be

necessary for the advisory committee to carry out its duties

under this chapter.

§ 2706.  Establishment of Pharmaceutical Accountability

Monitoring System.

(a)  General rule.--The department shall establish and

administer the Pharmaceutical Accountability Monitoring System

(PAMS) for monitoring all controlled substances that are

dispensed within this Commonwealth by all practitioners or

dispensers, including, but not limited to, a practitioner or

dispenser that dispenses to a person or ships to an address

within this Commonwealth.

(b)  Data compliance.--Data required by this section shall be

submitted in compliance with this section to the department by

the pharmacy or other dispensing entity.

(c)  Registration.--Each dispenser and practitioner

dispensing or prescribing controlled substances shall register

with and establish a user name and personal identification

number that permits access to the secure website housing PAMS

established by this chapter.

(d)  Queries.--A practitioner may query data through the

department. A Federal or State law enforcement official whose

duties include enforcing laws relating to controlled substances

and prescription drugs shall be provided access to the

information from PAMS relating to the person who is the subject

of a bona fide investigation of a drug abuse offense, including,

but not limited to, violations of the act of April 14, 1972

(P.L.233, No.64), known as The Controlled Substance, Drug,

Device and Cosmetic Act, insurance fraud, Medicare fraud or

Medicaid fraud pursuant to a bona fide investigation.

§ 2707.  Requirements for Pharmaceutical Accountability

Monitoring System.

(a)  Submission.--The dispenser shall, regarding each

controlled substance dispensed, submit by electronic means to

the department the following information using methods of

transmission protocols and in a format established by the

department:

(1)  Full name of the prescribing practitioner.

(2)  Prescriber Drug Enforcement Agency (DEA)

registration number.

(3)  Date the prescription was written.

(4)  Date the prescription was dispensed.

(5)  Full name, date of birth, gender and address of the

person for whom the prescription was written and dispensed.

(6)  Name of the controlled substance.

(7)  Quantity of the controlled substance prescribed.

(8)  Strength of the controlled substance.

(9)  Quantity of the controlled substance dispensed.

(10)  Dosage quantity and frequency prescribed.

(11)  Name of the pharmacy or other entity dispensing the

controlled substance.

(12)  Dispensing entity's DEA registration number and

NPI.

(13)  Source of payment for the prescription.

(14)  Other relevant information as established by

department regulations.

(b)  Frequency.--Each dispenser shall submit the information

required by this chapter as frequently as specified by the

department, but not later than seven days after the dispensing

of a controlled substance monitored by PAMS. The department

shall implement a real-time reporting requirement as

expeditiously as possible.

(c)  Maintenance.--The department shall maintain PAMS in an

electronic file or by other means established by the department

to facilitate use of the database.

(d)  Recordkeeping.--The department shall maintain a record

of PAMS queries for reference, including:

(1)  Identification of each person who requests or

receives information from PAMS.

(2)  The information provided to each person.

(3)  The date and time the information is requested and

provided.

(e)  Expungement.--The department shall remove from PAMS all

identifying information more than six years old from the date of

collection. Such information shall then be destroyed unless a

law enforcement agency or a professional licensing or

certification agency or board for prescribers or dispensers has

submitted a written request to the department for retention of

specific information. All requests shall comply with procedures

adopted by the department.

§ 2708.  Access to prescription information.

(a)  General rule.--Except as set forth in subsection (c),

prescription information submitted to the department and records

of requests to query the data shall be confidential and not

subject to disclosure under the act of February 14, 2008 (P.L.6,

No.3), known as the Right-to-Know Law.

(b)  Privacy procedures.--The department shall maintain

procedures to ensure that the privacy and confidentiality of

patients and patient information collected, recorded,

transmitted and maintained is not disclosed to persons except

those enumerated in subsection (c).

(c)  Limited availability.--The department shall make

information in PAMS available only to the following persons and

in accordance with department regulations:

(1)  Personnel of the department specifically assigned to

conduct internal reviews related to controlled substances

laws under the jurisdiction of the department.

(2)  Authorized department personnel engaged in analysis

of controlled substance prescription information as a part of

the assigned duties and responsibilities of their employment.

(3)  Qualified personnel for the purpose of bona fide

research or education. Data elements that would reasonably

identify a specific recipient, prescriber or dispenser shall

be deleted or redacted from such information prior to

disclosure. Release of the information shall only be made

pursuant to a written agreement between such qualified

personnel and the department in order to ensure compliance

with this chapter.

(4)  A practitioner, or a representative employed by the

practitioner, designated by the practitioner pursuant to

criteria established by the department, having authority to

prescribe controlled substances, to the extent that the

information relates to a current patient of the practitioner

to whom the practitioner is prescribing or considering

prescribing any controlled substance.

(5)  A pharmacist, or a designee employed by the

pharmacist, designated by the pharmacist pursuant to criteria

established by the department, having authority to dispense

controlled substances to the extent the information relates

specifically to a current patient to whom that pharmacist is

dispensing or considering dispensing any controlled

substance.

(6)  A designated representative from the Commonwealth or

out-of-State agency or board responsible for licensing or

certifying prescribers or dispensers who is involved in a

bona fide investigation of a prescriber or dispenser whose

professional practice was or is regulated by that agency or

board.

(7)  A medical examiner or county coroner for the purpose

of investigating the death of an individual.

(8)  A designated prescription monitoring official of a

state with which this Commonwealth has an interoperability

agreement may access prescription monitoring information in

accordance with the provisions of this chapter and procedures

adopted by the department.

(9)  An individual who is the recipient of a controlled

substance prescription entered into PAMS upon providing

evidence satisfactory to the PAMS manager that the individual

requesting the information is in fact the person about whom

the data entry was made.

(10)  The Office of Attorney General of Pennsylvania or

the equivalent law enforcement officer of another state may

access information from the PAMS for a bona fide

investigation of a criminal violation of law governing

controlled substances.

(d)  Dispenser access.--No person shall knowingly hinder a

pharmacist or practitioner who dispenses who is eligible to

receive information from PAMS from requesting and receiving such

information in a timely fashion.

§ 2709.  Unlawful acts and penalties.

(a)  Knowing and intentional release or use.--A person may

not knowingly and intentionally use, release, publish or

otherwise make available any information obtained from PAMS for

any purpose other than those specified in section 2708(c)

(relating to access to prescription information). A person who

does knowingly and intentionally release or use information from

PAMS that is not authorized in section 2708(c) commits a felony

of the third degree and is subject to a civil penalty of not

less than $5,000, or shall be sentenced to imprisonment of not

more than 90 days, or both, for each offense.

(b)  Misrepresentation or fraud.--Any person who obtains or

attempts to obtain information from PAMS by misrepresentation or

fraud commits a felony of the third degree.

(c)  Unauthorized purpose.--Any person who obtains or

attempts to obtain information from PAMS for a purpose other

than a purpose authorized by this section or by department

regulations commits a felony of the third degree.

(d)  Civil violation.--The procedure for determining a civil

violation of this subsection shall be in accordance with

department regulations. Civil penalties assessed under this

subsection shall be deposited in the General Fund, appropriated

to the department and dedicated to the controlled substance PAMS

operations.

(e)  Failure to submit.--The failure of a dispenser to submit

information to PAMS as required under this section, after the

department has submitted a specific written request for the

information or when the department determines the individual has

a demonstrable pattern of knowing that failure to submit the

information as required, is grounds for the appropriate

licensing board to take the following action in accordance with

the appropriate licensing act.

(1)  Prohibit an Internet pharmacy from conducting

business in this Commonwealth.

(2)  Refuse to issue a license to the individual.

(3)  Refuse to renew the individual's license.

(4)  Revoke, suspend, restrict or place on probation the

license.

(5)  Issue a public or private reprimand to the

individual.

(6)  Issue a cease and desist order.

(7)  Impose a civil penalty of not more than $1,000 for

each failure to submit information required by this act.

§ 2710.  Education and treatment.

(a)  General rule.--With the input and advice of the advisory

committee, the department shall:

(1)  assist the appropriate agency, board or association

for each category of authorized user in this act to

incorporate the appropriate information regarding PAMS into

the training, education or instruction provided to each

category of authorized user;

(2)  assist the State or regional chapter of the American

Society of Addiction Medicine, the Pennsylvania Medical

Society, the Pennsylvania Academy of Family Physicians and

the Pennsylvania Coalition of Nurse Practitioners to develop

a continuing education course for health care professionals

on prescribing practices, pharmacology and identification,

referral and treatment of patients addicted to or abusing

controlled substances monitored by PAMS; and

(3)  implement, or assist other appropriate agencies to

implement, an educational program to inform the public about

the use, diversion and abuse of, addiction to and treatment

for the addiction to the controlled substances monitored by

PAMS, including the nature and scope of PAMS.

(b)  Referral.--With the input and advice of the advisory

committee, the department shall refer prescribers and dispensers

it has reason to believe may be impaired to the appropriate

professional licensing or certification agency, and to the

appropriate impaired professionals associations, to provide

intervention, assessment and referral to alcohol and other drug

addiction treatment programs, and ongoing monitoring and follow-

up.

(c)  Identification.--With the input and advice of the

advisory committee, the department shall work with the patient's

individual practitioner and the appropriate alcohol and other

drug addiction treatment professionals to provide that patients

identified through PAMS as potentially addicted to a controlled

substance are assessed and referred to alcohol and other drug

addiction treatment programs.

§ 2711.  Immunity.

An individual who has submitted to or received information

from PAMS in accordance with this section may not be held

civilly liable or disciplined in a licensing board action for

having submitted the information or for not seeking or obtaining

information from the prescription monitoring program prior to

prescribing or dispensing a controlled substance to a patient.

§ 2712.  Additional provisions.

(a)  Funding.--A practitioner or a pharmacist shall not be

required to pay a fee or tax specifically dedicated to

establishment, operation or maintenance of the system.

(b)  Costs.--All costs associated with recording and

submitting data as required in this section shall be assumed by

the submitting dispenser.

(c)  Use of data.--Except as provided in subsection (d), data

provided to, maintained in or accessed from PAMS that may be

identified to, or with, a particular person is not subject to

discovery, subpoena or similar compulsory process in any civil,

judicial, administrative or legislative proceeding, nor shall

any individual or organization with lawful access to the data be

compelled to testify with regard to the data.

(d)  Exceptions.--The restrictions in subsection (c) do not

apply to:

(1)  A criminal proceeding.

(2)  A civil, judicial or administrative action brought

to enforce the provisions of this section.

§ 2713.  Use of money collected.

(a)  General rule.--The department may use the moneys

deposited in the General Fund and appropriated to the department

for the following purposes:

(1)  Maintenance and replacement of PAMS equipment,

including hardware and software.

(2)  Training of staff.

(3)  Pursuit of grants and matching funds.

(b)  Collections.--The department may collect any penalty

imposed under section 2707 (relating to unlawful acts and

penalties) and which is not paid by bringing an action in the

court of common pleas of the county in which the person owing

the debt resides or in the county where the department is

located.

(c)  Legal assistance.--The department may seek legal

assistance from the Attorney General or the county or district

attorney of the county in which the action is brought to collect

the fine.

(d)  Attorney fees and costs.--The court shall award

reasonable attorney fees and costs to the department for

successful collection actions under section 2707.

§ 2714.  Rules and regulations.

The department shall promulgate rules and regulations setting

forth the procedures and methods for implementing this chapter.

At a minimum, the rules and regulations shall include the

following:

(1)  Effectively enforce the limitations on access to

PAMS prescribed in section 2708 (relating to access to

prescription information).

(2)  Establish standards and procedures to ensure

accurate identification of individuals requesting information

or receiving information from PAMS.

(3)  Allow adequate time following implementation of this

chapter for dispensers and practitioners to make the changes

to their operational systems necessary to comply with this

chapter.

(4)  Allow for dispensers to have ease of transition to

comply with the requirements of the Pharmaceutical

Accountability Monitoring System.

(5)  Not place an undue burden on law enforcement seeking

information related to an investigation.

(6)  Dispensers and practitioners licensed to practice in

this Commonwealth shall not be held liable for failure to

comply with PAMS requirements until all changes are fully

operational and dispensers and practitioners have had

adequate time to make necessary adjustments to operating

systems and to receive training to fully accommodate such

changes upon promulgation of the regulations, but not later

than one year after the effective date of this chapter.

(7)  Dispensers who can show good cause for not

submitting data electronically may be authorized to submit

data manually if they lack Internet access.

§ 2715.  Evaluation, data analysis and reporting.

(a)  General rule.--The department shall design and implement

an evaluation component to identify:

(1)  cost benefits of PAMS;

(2)  the impact on efforts to reduce misuse, abuse,

overdose and diversion of, or addiction to, controlled

substances;

(3)  the impact on prescribing practices for controlled

substances;

(4)  the number of patients identified through PAMS as

potentially addicted to a controlled substance that were

assessed for alcohol and other drug addictions;

(5)  the number of patients in paragraph (4) that

received alcohol and other drug addiction treatment and the

names of the licensed alcohol and other drug addiction

treatment facilities in which the patients were treated;

(6)  the progress made in implementing real-time

reporting; and

(7)  other information relevant to policy, research and

education involving controlled substances and drugs of

concern monitored by PAMS.

(b)  Annual report.--The department shall annually report the

information specified in subsection (a) to the Public Health and

Welfare Committee of the Senate, the Human Services Committee of

the House of Representatives, the United States Department of

Justice, the Substance Abuse and Mental Health Services

Administration of the Office of National Drug Control Policy and

members of Pennsylvania's United States Congressional

delegation. Additionally, the department shall make the annual

report available to the public on its publicly accessible

Internet website.

§ 2716.  Concurrent jurisdiction.

The Attorney General shall have concurrent prosecutorial

jurisdiction with the county district attorney for violations of

this chapter. No person charged with a violation of this chapter

by the Attorney General shall have standing to challenge the

authority of the Attorney General to prosecute the case and, if

any such challenge is made, the challenge shall be dismissed and

no relief shall be available in the courts of this Commonwealth

to the person making the challenge.

Section 2.  The provisions of this act are severable. If any

provision of this act or its application to any person or

circumstance is held invalid, the invalidity shall not affect

other provisions or applications of this act which can be given

effect without the invalid provision or application.

Section 3.  This act shall take effect in 60 days.