H1694B2353A03896 SFL:AMY 10/15/13 #90 A03896
AMENDMENTS TO HOUSE BILL NO. 1694
Sponsor: REPRESENTATIVE BAKER
Printer's No. 2353
5PHARMACEUTICAL ACCOUNTABILITY MONITORING SYSTEM
72701. Short title of chapter.
92703. Scope of chapter.
112705. Advisory committee.
162708. Access to PAMS information.
172709. Unlawful acts and penalties.
182710. Education and treatment.
202712. Additional provisions.
212713. Use of money collected.
222714. Rules and regulations.
232715. Evaluation, data analysis and reporting.
242716. Concurrent jurisdiction.
262718. Expiration of chapter and expungement.
27§ 2701. Short title of chapter.
30§ 2702. Purpose.
31The purpose of this chapter is to reduce the abuse of
32controlled substances and fraud by providing a tool that will
33ensure that practitioners making prescribing decisions have
34complete and reliable information about what, if any, other
35prescription drugs have recently been prescribed to their
36patients. It is the purpose of this act to provide reporting
37mechanisms, with full confidentiality protections, in which
1dispensers report prescription information to a central
2repository, in order to identify ultimate user and practitioner
3behaviors that give rise to a reasonable suspicion that
4prescription drugs are being inappropriately obtained or
5prescribed, so that appropriate ameliorative and corrective
6action, including treatment for individuals suffering from drug
7and alcohol addiction, may be taken. This chapter is further
8intended to help detect, refer to regulatory agencies and deter
9prescription drug fraud and diversion.
10§ 2703. Scope of chapter.
11This chapter is intended to improve the Commonwealth's
12ability to enable informed and responsible prescribing and
13dispensing of controlled substances and to reduce diversion and
14misuse of such drugs in an efficient and cost-effective manner
15that will not impede the appropriate medical utilization of
16licit controlled substances.
17§ 2704. Definitions.
21"Active investigation." An investigation that is being
22conducted with a reasonable suspicion that it could lead to the
23filing of administrative, civil or criminal proceedings, or that
24is ongoing and continuing and for which there is a reasonable
25suspicion of securing an arrest or prosecution in the
27"ASAP." The American Society for Automation in Pharmacy.
28"Controlled substance." A drug, substance or immediate
29precursor included in Schedule II, III, IV or V of the act of
30April 14, 1972 (P.L.233, No.64), known as The Controlled
31Substance, Drug, Device and Cosmetic Act, or the Controlled
32Substances Act (Public Law 91-513, 84 Stat. 1236).
33"Continuing care provider." A facility licensed by the
34Department of Insurance under the act of June 18, 1984 (P.L.391,
35No.82), known as the Continuing-Care Provider Registration and
40"Department." The Department of Drug and Alcohol Programs.
47(1) The use of such substances on the order of a
48practitioner for the purpose of treating patients who are
49inpatient at a licensed hospital, a licensed ambulatory care
50facility, a continuing care provider or a licensed long-term
51care nursing facility.
1(2) A licensed provider under the LIFE program.
7(5) A wholesale distributor of a controlled substance.
10(7) A medical practitioner at a health care facility
11licensed by this Commonwealth if the quantity of controlled
12substances dispensed is limited to an amount adequate to
13treat the patient for a maximum of 24 hours with not more
14than two 24-hour cycles within any 15-day period.
17"Internet pharmacy." A person, entity or Internet site,
18whether in the United States or abroad, that knowingly or
19intentionally delivers, distributes or dispenses, or offers or
20attempts to deliver, distribute or dispense a controlled
21substance by means of the Internet, including a pharmacy.
24"Licensed health care facility." A health care facility that
25is licensed under the act of July 19, 1979 (P.L.130, No.48),
26known as the Health Care Facilities Act, or a personal care home
27or assisted living residence that is licensed under Article X of
28the act of June 13, 1967 (P.L.31, No.21), known as the Public
35"NDC." The National Drug Code.
36"NPI." The National Provider Identifier.
41"Practitioner." The term shall mean:
42(1) a physician, dentist, pharmacist, podiatrist,
43physician assistant, certified registered nurse practitioner,
44optometrist, dispensing veterinarian or other person
45licensed, registered or otherwise permitted to distribute,
46dispense or to administer a controlled substance, other drug
47or device in the course of professional practice or research
48in this Commonwealth; or
3"Ultimate user." A person who lawfully possesses a
4controlled substance, other drug, device or cosmetic for his own
5use or for the use of a member of his household or for
6administering to an animal in his care.
7§ 2705. Advisory committee.
12(1) The use of PAMS to improve patient care, to identify
13and address addiction and to facilitate the goal of reducing
14misuse, abuse, overdose, addiction to and diversion of
15controlled substances and drugs of concern.
35(9) The maintenance of technological improvements to
36facilitate the interoperability of PAMS with other State
37prescription drug monitoring programs and electronic health
38information systems and to facilitate practitioners' access
39to and use of PAMS.
44(12) Recommended appointments to the advisory committee.
45(b) Confidentiality.--For the purpose of providing input and
46advice pursuant to subsection (a), no advisory committee member
47shall receive prescription monitoring information which
48identifies, or could reasonably be used to identify, the
49ultimate use or practitioner who is the subject of the
50information. Notwithstanding any other law to the contrary, any
51and all meetings of the PAMS advisory committee are to be
1considered confidential and closed to the public. Members and
2staff shall maintain strict standards of confidentiality in the
3handling of all matters before the advisory committee. In
4addition, all relevant Federal and State laws regarding patient
5privacy and confidentiality will be adhered to. All material and
6information, regardless of form, medium or method of
7communication provided to or acquired by an advisory committee
8member or staff in the course of the advisory committee's work,
9shall be regarded as confidential information, shall not be
10disclosed and are not public records. In addition, all material
11and information, regardless of form, medium or method of
12communication, made or generated by a member of department staff
13in the course of the advisory committee's work, shall be
14regarded as confidential information and shall not be disclosed
15and are deemed not to be a public record. All necessary steps
16shall be taken by members and staff to safeguard the
17confidentiality of such material or information in conformance
18with Federal and State law.
30(iv) Two physicians recommended by the Pennsylvania
31Medical Society, one of whom holds membership in the
32American Society of Addiction Medicine and the other who
33is a physician with expertise in chronic pain management
51(xii) A representative of pharmacies recommended by
1the Pennsylvania Pharmacists' Association.
4(2) The department may also seek input from persons with
5recognized expertise, knowledge and experience in the
6establishment and maintenance of prescription monitoring
7programs, skills and expertise in alcohol and other drug
8addiction assessment and referral to addiction treatment or
9issues involving the misuse, abuse or diversion of, or the
10addiction to, controlled substances.
11(d) Quorum.--Nine members of the advisory committee shall
12constitute a quorum for the transaction of all business. The
13members shall elect a chairman and such other officers as deemed
14necessary whose duties shall be established by the advisory
15committee. The department shall convene the advisory committee
16at least quarterly using telecommunication whenever possible.
23(a) General rule.--With the input and advice of the advisory
24committee, the department shall establish and administer the
25Pharmaceutical Accountability Monitoring System (PAMS) for
26monitoring all controlled substances that are dispensed by
27dispensers or dispensing veterinarians within this Commonwealth,
28including, but not limited to, those dispensed to a person or
29shipped to an address within this Commonwealth. The system shall
30comply with the Health Insurance Portability and Accountability
31Act of 1996 (Public Law 104-191, 110 Stat. 1936) as it pertains
32to protected health information(PHI) and electronic protected
33health information (EPHI), as well as all other relevant Federal
34and State privacy and security laws and regulations.
35(b) Disclosure.--Each practitioner shall disclose to all
36persons for whom a controlled substance is prescribed that the
37identifying prescription information will be entered into the
38PAMS when the controlled substance is dispensed and may be
39accessed only for limited purposes by specified individuals.
43(d) Registration.--Each dispenser, practitioner and person
44designated by each dispenser and practitioner in accordance with
45section 2707(d) (relating to requirements for Pharmaceutical
46Accountability Monitoring System) shall register with and
47establish a user name and personal identification number that
48permits access to the secure website housing PAMS established by
1(a) Submission.--The dispenser shall, regarding each
2controlled substance dispensed, submit by electronic means,
3using the most current version of the ASAP prescription
4monitoring program web service standard, to the department the
5following information using methods of transmission protocols
6and in a format established by the department:
7(1) Full name of the prescribing practitioner.
10(3) Date the prescription was written.
11(4) Date the prescription was dispensed.
14(6) The NDC.
15(7) Quantity and days' supply.
18(9) Dispensing entity's DEA registration number and NPI.
19(10) Source of payment for the prescription.
20At the start up of the program, the most current version of the
21ASAP prescription monitoring program standard shall be used and
22updates are only required when substantive changes are made to
28(1) Pet's name.
29(2) Owner's name.
30(3) Pet's or owner's address.
31(4) Practice's name.
32(5) Dispensing veterinarian's name.
33(6) DEA license number.
34(7) Date the prescription was written.
35(8) Date the prescription was dispensed.
36(9) Name of the controlled substance.
37(10) Quantity and strength of the medication.
38(11) Dosage and frequency of the medication.
40(1) Each dispenser shall submit the information required
41by this chapter not later than seventy-two hours after the
42dispensing of a controlled substance monitored by PAMS. The
43department shall implement a real-time reporting requirement
44as expeditiously as possible.
5(2) The information provided to each person.
8(4) In the event that a request was made by the Office
9of Attorney General on behalf of Federal or State law
10enforcement officials, the name shall be listed as "OAG" so
11the names of law enforcement officials remain confidential.
12(f) Expungement.--The department shall remove from PAMS all
13information identifying the ultimate user or practitioner more
14than six years old from the date of collection. Such information
15shall then be destroyed unless a law enforcement agency or a
16professional licensing or certification agency or board for
17prescribers or dispensers has submitted a written request to the
18department for retention of specific information. All requests
19shall comply with procedures adopted by the department.
20§ 2708. Access to PAMS information.
21(a) General rule.--All information entered into the database
22or otherwise submitted to the department and records of requests
23to query the data shall be confidential and not subject to
24disclosure under the act of February 14, 2008 (P.L.6, No.3),
25known as the Right-to-Know Law.
26(b) Privacy procedures.--
27(1) The department shall maintain procedures to ensure
28that the privacy and confidentiality of patients and patient
29information collected, recorded, entered, transmitted and
30maintained is not disclosed to persons except those
31enumerated in subsections (e) and (f).
37(d) Database queries.--In addition to the department:
40(i) A practitioner or one person employed,
41designated and supervised by a practitioner pursuant to
42criteria established by the department to the extent that
43the information relates to a current patient of the
44practitioner or dispensing veterinarian to whom the
45practitioner or dispensing veterinarian is prescribing or
46considering prescribing any controlled substance.
47(ii) A pharmacist or designated pharmacy associate
48under the supervision of the pharmacist, designated by
49the pharmacist pursuant to criteria established by the
50department, having authority to dispense controlled
51substances to the extent the information relates
7(e) Information.--Upon written request, in the manner and
8form required by the department, information contained in PAMS
9shall be made available by the department only to the following
10persons and in accordance with department regulations:
19(3) Researchers for the purpose of bona fide research or
20education. All information that would identify the ultimate
21user or practitioner shall be deleted or redacted from such
22information prior to disclosure. Release of the information
23shall only be made pursuant to a written agreement between
24such researcher and the department in order to ensure
25compliance with this chapter.
26(4) A designated representative from the Commonwealth or
27out-of-State agency or board responsible for licensing or
28certifying practitioners who is involved in a bona fide
29investigation of a prescriber, dispensing veterinarian or
30dispenser whose professional practice was or is regulated by
31that agency or board.
34(6) A designated prescription monitoring official of a
35state with which this Commonwealth has an interoperability
36agreement may access prescription monitoring information in
37accordance with the provisions of this chapter.
38(7) An individual about whom information has been
39entered into PAMS upon providing evidence satisfactory to the
40department that the individual requesting the information is
41in fact the person about whom the data entry was made.
42(8) Authorized personnel of the Department of Public
43Welfare engaged in the administration of the medical
44assistance program, authorized personnel of the Insurance
45Department engaged in the administration of the Children's
46Health Insurance Program (CHIP) and authorized personnel of
47the Department of Aging engaged in the administration of the
48Pharmaceutical Assistance Contract for the Elderly program.
2(g) Law enforcement access.--
3(1) The Office of Attorney General shall submit requests
4for information from PAMS to the department on behalf of all
5law enforcement agencies, including, but not limited to, the
6Office of Attorney General and Federal, State and local law
7enforcement agencies, as well as an Attorney General or
8similar official from another state. The department shall
9provide the Office of Attorney General access to information
11(i) Upon request of the Office of Attorney General,
12the department shall provide information from PAMS in
13relation to a controlled substance on Schedule II of the
14act of April 14, 1972 (P.L.233, No.64), known as The
15Controlled Substance, Drug, Device and Cosmetic Act.
16(ii) If the Attorney General determines that
17information in PAMS is relevant to an active
18investigation, upon request of the Office of Attorney
19General, the department shall provide the office access
20to information from PAMS in relation to a controlled
21substance on Schedules III, IV and V of The Controlled
22Substance, Drug, Device and Cosmetic Act only as it
23relates to persons who are the subject of the active
25(2) The department may provide access to information
26from PAMS to a grand jury empaneled to investigate a criminal
27violation of a law governing controlled substances,
28including, but not limited to, violations of The Controlled
29Substance, Drug, Device and Cosmetic Act, and to investigate
30insurance, Medicare or Medicaid fraud.
34§ 2709. Unlawful acts and penalties.
37(1) Knowingly, intentionally or negligently uses,
38releases, publishes or otherwise makes available any
39information obtained from PAMS for any purpose other than
40those specified in section 2708 (relating to access to PAMS
47(b) Grading.--A person who violates subsection (a)(1), (2)
48or (3) commits a felony of the third degree and shall, upon
49conviction, be sentenced to pay a fine of not less than $5,000
50or to imprisonment for not more than 90 days, or both.
51(c) Civil violation.--The procedure for determining a civil
1violation of this subsection shall be in accordance with
2department regulations. Civil penalties assessed under this
3subsection shall be deposited in the General Fund, appropriated
4to the department and dedicated to PAMS operations.
5(d) Failure to submit.--The failure of a dispenser or
6dispensing veterinarian to submit information to PAMS as
7required under this section, after the department has submitted
8a specific written request for the information or when the
9department determines the individual has a demonstrable pattern
10of failure to submit the information as required, is grounds for
11the appropriate licensing board to take the following action in
12accordance with the appropriate licensing act:
15(2) Refuse to issue a license to the individual.
16(3) Refuse to renew the individual's license.
17(4) Revoke or suspend the license.
18(5) Restrict or place on probation the licensee.
21(7) Issue a cease and desist order.
29§ 2710. Education and treatment.
32(1) assist the appropriate agency, board or association
33for each category of person authorized to contribute or
34access information from PAMS to incorporate the appropriate
35information regarding PAMS into the training, education or
36instruction provided to each category of authorized user;
37(2) assist the State or regional chapter of the American
38Society of Addiction Medicine, the Pennsylvania Medical
39Society, the Pennsylvania Psychiatric Society, the
40Pennsylvania Veterinary Medical Association, the Pennsylvania
41Academy of Family Physicians and the Pennsylvania Coalition
42of Nurse Practitioners to develop a continuing education
43course for health care professionals on prescribing
44practices, pharmacology and identification, referral and
45treatment of patients addicted to or abusing controlled
46substances monitored by PAMS; and
47(3) implement, or assist other appropriate agencies to
48implement, an educational program to inform the public about
49the use, diversion and abuse of, addiction to and treatment
50for the addiction to the controlled substances monitored by
51PAMS, including the nature and scope of PAMS.
4(1) Refer a practitioner it has reasonable suspicion to
5believe may be impaired to the appropriate impaired
6professionals associations to provide intervention,
7assessment and referral to alcohol and other drug addiction
8treatment programs, including ongoing monitoring and follow-
10(2) Notify the appropriate licensing agency or board.
11(c) Identification.--With the input and advice of the
12advisory committee, the department shall work with the patient's
13individual practitioner and the appropriate alcohol and other
14drug addiction treatment professionals to provide that patients
15identified through PAMS as potentially addicted to a controlled
16substance are assessed and referred to a licensed addiction
18§ 2711. Immunity.
19An individual who has submitted to or received information
20from PAMS in accordance with section 2706 (relating to
21establishment of Pharmaceutical Accountability Monitoring
22System) may not be held civilly liable or disciplined in a
23licensing board action for having submitted the information or
24for not seeking or obtaining information from the prescription
25monitoring program prior to prescribing or dispensing a
26controlled substance to an ultimate user except as otherwise
27determined by a licensing agency or board or as set forth in
29§ 2712. Additional provisions.
36(c) Use of data.--Except as provided in subsection (d), data
37provided to, maintained in or accessed from PAMS that may be
38identified to, or with, a particular person is not subject to
39discovery, subpoena or similar compulsory process in any civil,
40criminal, judicial, administrative or legislative proceeding,
41nor shall any individual or organization with lawful access to
42the data be compelled to testify with regard to the data.
46§ 2713. Use of money collected.
1(2) Training of staff.
2(3) Pursuit of grants and matching funds.
5(b) Collections.--The department may collect any penalty
6imposed under section 2709 (relating to unlawful acts and
7penalties) and which is not paid by bringing an action in the
8court of common pleas of the county in which the person owing
9the debt resides or in the county where the department is
14(d) Attorney fees and costs.--The court shall award
15reasonable attorney fees and costs to the department, the
16Attorney General or the district attorney of the county in which
17the action is brought to collect the fine for successful
18collection actions under section 2709 (relating to unlawful acts
20§ 2714. Rules and regulations.
21With input and advice from the advisory committee, the
22department shall promulgate rules and regulations setting forth
23the procedures and methods for implementing this chapter. At a
24minimum, the rules and regulations shall include the following:
31(3) Allow adequate time following implementation of this
32chapter for dispensers, dispensing veterinarians and
33practitioners to make the changes to their operational
34systems necessary to comply with this chapter.
40(6) Practitioners shall not be held liable for failure
41to comply with PAMS requirements until all changes are fully
42operational and practitioners have had adequate time to make
43necessary adjustments to operating systems and to receive
44training to fully accommodate such changes upon promulgation
45of the regulations, but not later than one year after the
46effective date of this chapter.
51§ 2715. Evaluation, data analysis and reporting.
4(1) cost benefits of PAMS;
13(5) the number of individuals in paragraph (4) that were
14referred for alcohol and other drug addiction treatment and
15the names of the licensed addiction treatment programs in
16which the individuals were treated;
22(b) Annual report.--The department shall annually report the
23information specified in subsection (a) to the Public Health and
24Welfare Committee of the Senate, the Human Services Committee of
25the House of Representatives, the United States Department of
26Justice, the Substance Abuse and Mental Health Services
27Administration of the Office of National Drug Control Policy and
28members of Pennsylvania's United States Congressional
29delegation. Additionally, the department shall make the annual
30report available to the public on its publicly accessible
32(c) Evaluation.--Within six years of the effective date of
33this act, the department shall submit to the chairman and
34minority chairman of the Public Health and Welfare Committee of
35the Senate and the chairman and minority chairman of the Human
36Services Committee of the House of Representatives, a written
37report containing information regarding the collection of data
38within PAMS. The report must include, but need not be limited
39to, the following information pertaining to the data collected
40within PAMS since its inception:
1(5) The rate by which practitioners are utilizing PAMS
2to query patients identified as being potentially addicted to
3a controlled substance through PAMS for referral to alcohol
4and other drug addiction treatment programs.
18§ 2716. Concurrent jurisdiction.
19The Attorney General shall have concurrent prosecutorial
20jurisdiction with the county district attorney for violations of
21this chapter. No person charged with a violation of this chapter
22by the Attorney General shall have standing to challenge the
23authority of the Attorney General to prosecute the case and, if
24any such challenge is made, the challenge shall be dismissed and
25no relief shall be available in the courts of this Commonwealth
26to the person making the challenge.
27§ 2717. Nonapplicability.
28The requirements of this chapter shall not apply to:
31(2) the administration or dispensing of a controlled
32substance that is otherwise exempted as determined by the
33United States Secretary of Health and Human Services under
34the National All Schedules Prescription Electronic Reporting
35Act of 2005 (Public Law 109-60, 119 Stat. 1979).
36§ 2718. Expiration of chapter and expungement.
47Section 4. The provisions of this act are severable. If any
48provision of this act or its application to any person or
49circumstance is held invalid, the invalidity shall not affect
50other provisions or applications of this act which can be given
51effect without the invalid provision or application.
1Section 5. This act shall take effect as follows:
4(2) This section shall take effect immediately.