AN ACT

 

1Amending Title 44 (Law and Justice) of the Pennsylvania
2Consolidated Statutes, establishing the Prescription Drug
3Monitoring Program; providing for powers and duties of the
4Department of Drug and Alcohol Programs; and imposing
5penalties.

6The General Assembly of the Commonwealth of Pennsylvania
7hereby enacts as follows:

8Section 1. Title 44 of the Pennsylvania Consolidated
9Statutes is amended by adding a chapter to read:

10CHAPTER 27

11PRESCRIPTION DRUG MONITORING PROGRAM

12Sec.

132701. Scope of chapter.

142702. Definitions.

152703. Prescription Drug Monitoring Program.

162704. Requirements for monitoring system.

172705. Access to prescription information.

182706. Unlawful acts and penalties.

192707. Education and treatment.

12708. Immunity.

22709. Additional provisions.

32710. Use of money collected.

42711. Rules and regulations.

52712. Evaluation, data analysis and reporting.

62713. Concurrent jurisdiction.

7§ 2701. Scope of chapter.

8This chapter relates to prescription drug monitoring.

9§ 2702. Definitions.

10The following words and phrases when used in this chapter
11shall have the meanings given to them in this section unless the
12context clearly indicates otherwise:

13"Active investigation." An investigation that is being
14conducted with a reasonable good faith belief that it could lead
15to the filing of administrative, civil or criminal proceedings
16or that is ongoing and continuing and for which there is a
17reasonable good faith anticipation of securing an arrest or
18prosecution in the forseeable future.

19"Alcohol and other drug addiction treatment program." Any
20facility or treatment program that is licensed by the
21Commonwealth to provide alcohol and other drug addiction
22treatment on a hospital, nonhospital residential or outpatient
23basis.

24"Controlled substance." A drug, substance or immediate
25precursor included in Schedule II, III, IV or V of the act of
26April 14, 1972 (P.L.233, No.64), known as The Controlled
27Substance, Drug, Device and Cosmetic Act, or the Controlled
28Substances Act (Public Law 91-513, 84 Stat. 1236).

29"Department." The Department of Drug and Alcohol Programs of
30the Commonwealth.

1"Dispense." To deliver a controlled substance, other drug or
2device to an ultimate user by or pursuant to the lawful order of
3a practitioner.

4"Dispenser." A practitioner who dispenses in this
5Commonwealth, including mail order and Internet sales of
6pharmaceuticals. The term does not include any of the following:

7(1) A licensed health care facility or long-term care
8pharmacy that distributes the controlled substance, other
9drug or device for the purpose of inpatient hospital or long-
10term care facility administration.

11(2) A practitioner or other authorized person who
12administers a controlled substance, other drug or device.

13(3) A wholesale distributor of a controlled substance.

14(4) A hospice care provider.

15(5) A medical practitioner at a health care facility
16licensed by this Commonwealth if the quantity of controlled
17substances dispensed is limited to an amount adequate to
18treat the patient for a maximum of 24 hours with not more
19than two 24-hour cycles within any 15-day period.

20"Internet pharmacy." A person, entity or Internet website,
21whether in the United States or abroad, that knowingly or
22intentionally delivers, distributes or dispenses, or offers or
23attempts to deliver, distribute or dispense, a controlled
24substance by means of the Internet, including a pharmacy.

25"Licensed health care facility." A health care facility that
26is licensed under Article X of the act of June 13, 1967 (P.L.
2731, No.21), known as the Public Welfare Code, or the act of July
2819, 1979 (P.L.130, No.48), known as the Health Care Facilities
29Act.

30"Monitoring program." The Prescription Drug Monitoring

1Program established in section 2703 (relating to Prescription
2Drug Monitoring Program).

3"Monitoring system." The monitoring program database
4established and maintained under section 2704(c) (relating to
5requirements for monitoring system).

6"Practitioner." The term includes:

7(1) A physician, dentist, veterinarian, pharmacist,
8podiatrist, physician assistant, certified registered nurse
9practitioner or other person licensed, registered or
10otherwise permitted to distribute, dispense or to administer
11a controlled substance, other drug or device in the course of
12professional practice or research in this Commonwealth.

13(2) A pharmacy, hospital, clinic or other institution
14licensed, registered or otherwise permitted to distribute,
15dispense, conduct research with respect to or to administer a
16controlled substance, other drug or device in the course of
17professional practice or research in this Commonwealth.

18"Ultimate user." A person who lawfully possesses a
19controlled substance, other drug, device or cosmetic for the
20person's own use or for the use of a member of the person's
21household or for administering to an animal in the person's
22care.

23§ 2703. Prescription Drug Monitoring Program.

24(a) General rule.--The department shall establish and
25administer the Prescription Drug Monitoring Program for
26identifying controlled substances that are dispensed within this
27Commonwealth by a practitioner or dispenser, including, but not
28limited to, a practitioner or dispenser that dispenses to a
29person or ships to an address within this Commonwealth.

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

1submitted in compliance with this section to the department by a
2pharmacy or other dispensing entity.

3(c) Registration.--Each dispenser and practitioner
4dispensing or prescribing controlled substances shall register
5with and establish a user name and personal identification
6number that permits access to the secure Internet website
7housing the monitoring system.

8(d) Practitioner queries.--A practitioner may query data
9through the department.

10(e) Law enforcement queries.--A Federal or State law
11enforcement official whose duties include enforcing laws
12relating to controlled substances and prescription drugs shall
13be provided access to the information from the monitoring system
14relating to the person who is the subject of an active
15investigation of:

16(1) A drug abuse offense, including, but not limited to,
17violations of the act of April 14, 1972 (P.L.233, No.64),
18known as The Controlled Substance, Drug, Device and Cosmetic
19Act.

20(2) Insurance fraud.

21(3) Medicare fraud.

22(4) Medicaid fraud.

23§ 2704. Requirements for monitoring system.

24(a) Submission.--The dispenser shall, regarding each
25controlled substance dispensed, submit by electronic means to
26the department the following information using methods of
27transmission protocols and in a format established by the
28department:

29(1) Full name of the prescribing practitioner.

30(2) Prescriber Drug Enforcement Agency (DEA)

1registration number.

2(3) Date the prescription was written.

3(4) Date the prescription was dispensed.

4(5) Full name, date of birth, gender and address of the
5person for whom the prescription was written and dispensed.

6(6) Name of the controlled substance.

7(7) Quantity of the controlled substance prescribed.

8(8) Strength of the controlled substance.

9(9) Quantity of the controlled substance dispensed.

10(10) Dosage quantity and frequency prescribed.

11(11) Name of the pharmacy or other entity dispensing the
12controlled substance.

13(12) Dispensing entity's DEA registration number and
14National Provider Identifier (NPI).

15(13) Source of payment for the prescription.

16(14) Other relevant information as established by
17department regulations.

18(b) Frequency.--Each dispenser shall submit the information
19required by this chapter as frequently as specified by the
20department, but not later than seven days after the dispensing
21of a controlled substance identified by the monitoring program.
22The department shall implement a real-time reporting requirement
23as expeditiously as possible.

24(c) Database.--The department shall establish and maintain a
25monitoring system in an electronic file or by other means
26established by the department to facilitate use of the
27monitoring program database.

28(d) Recordkeeping.--The department shall maintain a record
29of the monitoring system queries for reference, including:

30(1) Identification of each person who requests or

1receives information from the monitoring system.

2(2) The information provided to each person.

3(3) The date and time the information is requested and
4provided.

5(e) Expungement.--The department shall remove from the
6monitoring system all identifying information more than six
7years old from the date of collection. The information shall
8then be destroyed unless a law enforcement agency or a
9professional licensing or certification agency or board for
10prescribers or dispensers has submitted a written request to the
11department for retention of specific information. All requests
12shall comply with procedures adopted by the department.

13§ 2705. Access to prescription information.

14(a) General rule.--Except as set forth in subsection (c),
15prescription information submitted to the department and records
16of requests to query the data shall be confidential and not
17subject to disclosure under the act of February 14, 2008 (P.L.6,
18No.3), known as the Right-to-Know Law.

19(b) Privacy procedures.--The department shall maintain
20procedures to ensure that the privacy and confidentiality of
21patients and patient information collected, recorded,
22transmitted and maintained is not disclosed to persons except
23those enumerated in subsection (c).

24(c) Limited availability.--The department shall make
25information in the monitoring system available only to the
26following persons and in accordance with department regulations:

27(1) Personnel of the department specifically assigned to
28conduct internal reviews related to controlled substance laws
29under the jurisdiction of the department.

30(2) Authorized department personnel engaged in analysis

1of controlled substance prescription information as a part of
2the assigned duties and responsibilities of their employment.

3(3) Qualified personnel for the purpose of bona fide
4research or education. Data elements that would reasonably
5identify a specific recipient, prescriber or dispenser shall
6be deleted or redacted from the information prior to
7disclosure. Release of the information shall only be made
8pursuant to a written agreement between the qualified
9personnel and the department in order to ensure compliance
10with this chapter.

11(4) A practitioner or a representative employed by the
12practitioner, designated by the practitioner pursuant to
13criteria established by the department, having authority to
14prescribe controlled substances to the extent that the
15information relates to a current patient of the practitioner
16to whom the practitioner is prescribing or considering
17prescribing any controlled substance.

18(5) A pharmacist or a designee employed by the
19pharmacist, designated by the pharmacist pursuant to criteria
20established by the department, having authority to dispense
21controlled substances to the extent the information relates
22specifically to a current patient to whom that pharmacist is
23dispensing or considering dispensing any controlled
24substance.

25(6) A designated representative from the Commonwealth or
26an out-of-State agency or board responsible for licensing or
27certifying prescribers or dispensers who is involved in an
28active investigation of a prescriber or dispenser whose
29professional practice was or is regulated by that agency or
30board.

1(7) A medical examiner or county coroner for the purpose
2of investigating the death of an individual.

3(8) A designated prescription monitoring official of a
4state with which this Commonwealth has an interoperability
5agreement who may access prescription drug monitoring
6information in accordance with the provisions of this chapter
7and procedures adopted by the department.

8(9) An individual who is the recipient of a controlled
9substance prescription entered into the monitoring system
10upon providing evidence satisfactory to the monitoring system
11manager that the individual requesting the information is in
12fact the person about whom the data entry was made.

13(10) The Office of Attorney General or the equivalent
14law enforcement officer of another state to the extent
15necessary for an active investigation of a criminal violation
16of law governing controlled substances.

17(d) Dispenser access.--No person may knowingly hinder a
18practitioner who dispenses who is eligible to receive
19information from the monitoring system from requesting and
20receiving the information in a timely fashion.

21§ 2706. Unlawful acts and penalties.

22(a) Prohibition.--A person may not knowingly and
23intentionally use, release, publish or otherwise make available
24any information obtained from the monitoring system for any
25purpose other than those specified in section 2705(c) (relating
26to access to prescription information).

27(b) Penalty.--A person who violates subsection (a):

28(1) Is subject to a civil penalty of not less than
29$5,000 for each violation.

30(2) Commits a felony of the third degree.

1(c) Misrepresentation or fraud.--Any person who obtains or
2attempts to obtain information from the monitoring system by
3misrepresentation or fraud commits a felony of the third degree.

4(d) Unauthorized purpose.--Any person who obtains or
5attempts to obtain information from the monitoring system for a
6purpose other than a purpose authorized by this chapter or by
7department regulations commits a felony of the third degree.

8(e) Civil violation.--The procedure for determining a civil
9violation of this section shall be in accordance with department
10regulations. Civil penalties assessed under this section shall
11be:

12(1) Deposited in the General Fund.

13(2) Appropriated to the department.

14(3) Dedicated to the monitoring program.

15(f) Failure to submit.--The failure of a dispenser to submit
16information to the monitoring system as required under this
17chapter, after the department has submitted a specific written
18request for the information or when the department determines
19the dispenser has a demonstrable pattern of failure to submit
20the information as required, is grounds for the appropriate
21licensing board to take the following action in accordance with
22the appropriate licensing act:

23(1) Prohibit an Internet pharmacy from conducting
24business in this Commonwealth.

25(2) Refuse to issue a license to the individual.

26(3) Refuse to renew the individual's license.

27(4) Revoke, suspend, restrict or place on probation the
28license.

29(5) Issue a public or private reprimand to the
30individual.

1(6) Issue a cease and desist order.

2(7) Impose a civil penalty of not more than $1,000 for
3each failure to submit information required by this chapter.

4§ 2707. Education and treatment.

5(a) General rule.--The department shall:

6(1) Assist the appropriate agency, board or association
7for each category of authorized user in this chapter to
8incorporate the appropriate information regarding the
9monitoring program into the training, education or
10instruction provided to each category of authorized user.

11(2) Assist the State or regional chapter of the American
12Society of Addiction Medicine, the Pennsylvania Medical
13Society, the Pennsylvania Academy of Family Physicians and
14the Pennsylvania Coalition of Nurse Practitioners to develop
15a continuing education course for health care professionals
16on prescribing practices, pharmacology and identification,
17referral and treatment of patients addicted to or abusing
18controlled substances identified by the monitoring program.

19(3) Implement or assist other appropriate agencies to
20implement an educational program to inform the public about
21the use, diversion and abuse of, addiction to and treatment
22for the addiction to the controlled substances identified by
23the monitoring program, including the nature and scope of the
24program.

25(b) Referral.--The department shall refer prescribers and
26dispensers it has reason to believe may be impaired to the
27appropriate professional licensing or certification agency and
28to the appropriate impaired professionals associations to
29provide intervention, assessment and referral to alcohol and
30other drug addiction treatment programs and ongoing monitoring

1and follow-up.

2(c) Identification.--The department shall work with the
3patient's individual practitioner and the appropriate alcohol
4and other drug addiction treatment professionals to provide that
5patients identified through the monitoring system as potentially
6addicted to a controlled substance are assessed and referred to
7alcohol and other drug addiction treatment programs.

8§ 2708. Immunity.

9An individual who has submitted to or received information
10from the monitoring system in accordance with this chapter may
11not be held civilly liable or disciplined in a licensing board
12action for having submitted the information or for not seeking
13or obtaining information from the monitoring program prior to
14prescribing or dispensing a controlled substance to a patient.

15§ 2709. Additional provisions.

16(a) Funding.--A practitioner shall not be required to pay a
17fee or tax specifically dedicated to establishment, operation or
18maintenance of the monitoring program.

19(b) Costs.--All costs associated with recording and
20submitting data as required in this chapter shall be assumed by
21the submitting dispenser.

22(c) Use of data.--Except as provided in subsection (d), data
23provided to, maintained in or accessed from the monitoring
24system that may be identified to or with a particular person is
25not subject to discovery, subpoena or similar compulsory process
26in any civil, judicial, administrative or legislative
27proceeding, nor shall any individual or organization with lawful
28access to the data be compelled to testify with regard to the
29data.

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

1apply to:

2(1) A criminal proceeding.

3(2) A civil, judicial or administrative action brought
4to enforce this chapter.

5§ 2710. Use of money collected.

6(a) General rule.--The department may use the moneys
7deposited in the General Fund and appropriated to the department
8for the following purposes:

9(1) Maintenance and replacement of monitoring system
10equipment, including hardware and software.

11(2) Training of staff.

12(3) Pursuit of grants and matching funds.

13(b) Collections.--The department may collect any penalty
14imposed under section 2706 (relating to unlawful acts and
15penalties) and which is not paid by bringing an action in the
16court of common pleas of the county in which the person owing
17the debt resides or in the county where the department is
18located.

19(c) Legal assistance.--The department may seek legal
20assistance from the Attorney General or the county or district
21attorney of the county in which the action is brought to collect
22the fine.

23(d) Attorney fees and costs.--The court shall award
24reasonable attorney fees and costs to the department for
25successful collection actions under section 2706.

26§ 2711. Rules and regulations.

27The department shall promulgate rules and regulations setting
28forth the procedures and methods for implementing this chapter.
29At a minimum, the rules and regulations shall include the
30following:

1(1) Effectively enforce the limitations on access to the
2monitoring system prescribed in section 2705 (relating to
3access to prescription information).

4(2) Establish standards and procedures to ensure
5accurate identification of individuals requesting information
6or receiving information from the monitoring system.

7(3) Allow adequate time following implementation of this
8chapter for dispensers and practitioners to make the changes
9to their operational systems necessary to comply with this
10chapter.

11(4) Allow for dispensers to have ease of transition to
12comply with the requirements of the monitoring system.

13(5) Not place an undue burden on law enforcement seeking
14information related to an investigation.

15(6) Provide that dispensers and practitioners licensed
16to practice in this Commonwealth shall not be held liable for
17failure to comply with monitoring system requirements until
18all changes are fully operational and dispensers and
19practitioners have had adequate time to make necessary
20adjustments to operating systems and to receive training to
21fully accommodate the changes upon promulgation of the
22regulations, but not later than one year after the effective
23date of this chapter.

24(7) Provide that dispensers who can show good cause for
25not submitting data electronically may be authorized to
26submit data manually if they lack Internet access.

27§ 2712. Evaluation, data analysis and reporting.

28(a) General rule.--The department shall design and implement
29an evaluation component to identify:

30(1) Cost benefits of the monitoring program.

1(2) The impact on efforts to reduce misuse, abuse,
2overdose and diversion of or addiction to controlled
3substances.

4(3) The impact on prescribing practices for controlled
5substances.

6(4) The number of patients identified through the
7monitoring system as potentially addicted to a controlled
8substance that were assessed for alcohol and other drug
9addictions.

10(5) The number of patients in paragraph (4) that
11received alcohol and other drug addiction treatment and the
12names of the licensed alcohol and other drug addiction
13treatment facilities in which the patients were treated.

14(6) The progress made in implementing real-time
15reporting.

16(7) Other information relevant to policy, research and
17education involving controlled substances and drugs of
18concern identified by the monitoring program.

19(b) Annual report.--The department shall annually report the
20information specified in subsection (a) to the Public Health and
21Welfare Committee of the Senate and the Human Services Committee
22of the House of Representatives. Additionally, the department
23shall make the annual report available to the public on its
24publicly accessible Internet website.

25§ 2713. Concurrent jurisdiction.

26The Attorney General shall have concurrent prosecutorial
27jurisdiction with the county district attorney for violations of
28this chapter. No person charged with a violation of this chapter
29by the Attorney General shall have standing to challenge the
30authority of the Attorney General to prosecute the case and, if

1a challenge is made, the challenge shall be dismissed, and no
2relief shall be available in the courts of this Commonwealth to
3the person making the challenge.

4Section 2. The provisions of this act are severable. If any
5provision of this act or its application to any person or
6circumstance is held invalid, the invalidity shall not affect
7other provisions or applications of this act which can be given
8effect without the invalid provision or application.

9Section 3. This act shall take effect in 60 days.