AN ACT

 

1Providing for prescription drug monitoring; creating the
2Prescription Drug Monitoring Board; establishing the
3Achieving Better Care by Monitoring All Prescriptions
4Program; and providing for unlawful acts and penalties.

5TABLE OF CONTENTS

6Section 1. Short title.

7Section 2. Purpose.

8Section 3. Definitions.

9Section 4. Prescription Drug Monitoring Board.

10Section 5. Powers and duties of board

11Section 6. Establishment of program.

12Section 7. Requirements for dispensers.

13Section 8. Requirements for prescribers.

14Section 9. Access to prescription information.

15Section 10. Unlawful act and penalties.

16Section 11. Program funding.

17Section 12. Admissibility.

18Section 13. Annual report.

1Section 14. Regulations.

2Section 15. Concurrent jurisdiction.

3Section 16. Effective date.

4The General Assembly of the Commonwealth of Pennsylvania
5hereby enacts as follows:

6Section 1. Short title.

7This act shall be known and may be cited as the Achieving
8Better Care by Monitoring All Prescriptions Program (ABC-MAP)
9Act.

10Section 2.  Purpose.

11This act is intended to increase the quality of patient care
12by giving prescribers and dispensers access to a patient's
13prescriptive history through an electronic data system that will
14alert medical professionals to potential dangers for purposes of
15making treatment determinations. The act further intends that
16patients will have a thorough and easily obtainable record of
17prescriptions for purposes of making educated and thoughtful
18health care decisions. Additionally, the act seeks to aid
19regulatory and law enforcement agencies in the detection and
20prevention of fraud, drug abuse and the criminal diversion of
21controlled substances.

22Section 3.  Definitions.

23The following words and phrases when used in this act shall
24have the meanings given to them in this section unless the
25context clearly indicates otherwise:

26"Board."  The Prescription Drug Monitoring Board established
27in section 4.

28"Controlled substance."  A drug, substance or immediate
29precursor included in the act of April 14, 1972 (P.L.233,
30No.64), known as The Controlled Substance, Drug, Device and

1Cosmetic Act, or the Controlled Substances Act (Public Law 91-
2513, 84 Stat. 1236).

3"Department."  The Department of Health of the Commonwealth.

4"Dispense."  To deliver a controlled substance, other drug or
5device to a patient by or pursuant to the lawful order of a
6prescriber.

7"Dispenser."  A person lawfully authorized to dispense in
8this Commonwealth, including mail order and Internet sales of
9pharmaceuticals. The term does not include any of the following:

10(1)  A licensed health care facility or long-term care
11pharmacy that distributes the controlled substance, other
12drug or device for the purpose of inpatient hospital or long-
13term care facility administration.

14(2)  A correctional facility if the confined person
15cannot lawfully visit a prescriber outside the correctional
16facility without being escorted by a corrections officer.

17(3)  An authorized person who administers a controlled
18substance, other drug or device.

19(4)  A wholesale distributor of a controlled substance.

20(5)  A licensed provider in the LIFE program.

21(6)  A provider of hospice as defined in act of July 19,
221979 (P.L.130, No.48), known as the Health Care Facilities
23Act.

24(7)  A prescriber at a health care facility licensed by
25this Commonwealth if the quantity of controlled substances
26dispensed is limited to an amount adequate to treat the
27patient for a maximum of 24 hours with not more than two 24-
28hour cycles within any 15-day period.

29(8)  A veterinarian.

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

1is licensed under Article X of the act of June 13, 1967 (P.L.31,
2No.21), known as the Public Welfare Code, or the act of July 19,
31979 (P.L.130, No.48), known as the Health Care Facilities Act.

4"LIFE program."  The program of medical and supportive
5services known as Living Independently For Elders.

6"Prescriber."  A person who is licensed, registered or
7otherwise lawfully authorized to distribute, dispense or to
8administer a controlled substance, other drug or device in the
9course of professional practice or research in this
10Commonwealth. The term does not include a veterinarian.

11"Program."  The Achieving Better Care by Monitoring All
12Prescriptions Program (ABC-MAP) created in section 6.

13Section 4.  Prescription Drug Monitoring Board.

14(a)  Creation.--The Prescription Drug Monitoring Board is
15created in the Department of Health. The board shall administer
16the program. The department shall perform budgetary, accounting,
17procurement and other support services.

18(b)  Board composition.--The board shall consist of the
19following individuals or their designees:

20(1)  Secretary of Health, who shall serve as chairperson.

21(2)  Secretary of Public Welfare.

22(3)  Secretary of Drug and Alcohol Programs.

23(4)  Secretary of State.

24(5)  The Insurance Commissioner.

25(6)  Secretary of Aging.

26(7)  The Commissioner of Pennsylvania State Police.

27(8)  The Attorney General.

28(c)  Term limits.--Each member of the board shall serve for
29the duration of their elected or appointed position.

30(d)  Meetings.--The board shall meet at least once a year for

1the purpose of assessing the costs and benefits of the program
2and effectuating any necessary changes.

3Section 5.  Powers and duties of board.

4The board shall have the following powers and duties:

5(1)  Evaluate and secure a vendor of an electronic
6prescription monitoring system for the purpose of carrying
7out the provisions of this act.

8(2)  Appoint an advisory group comprised of dispensers,
9prescribers, law enforcement and individuals with expertise
10considered important to the operation of the program. All
11members shall have unique perspectives and will provide input
12and recommendations to the board regarding the establishment
13and maintenance of the program. The advisory group shall not
14exceed twelve members.

15(3)  Modify the list of required controlled substances to
16be reported based on the benefit to the citizens of this
17Commonwealth.

18(4)  Phase in an enforcement process so that dispensers
19and prescribers may transition and have adequate time to make
20the necessary changes to their operating systems.

21(5)  Develop protocols and policies to:

22(i)  Require more frequent reporting of data should
23technology permit and so long as there is little or no
24fiscal impact to the Commonwealth or those reporting.

25(ii)  Evaluate the information in the program.

26(iii)  Allow for authorized department personnel to
27conduct internal reviews, analyses and interpret program
28data.

29(iv)  Safeguard the release of information to
30authorized users and department personnel and ensure the

1privacy and confidentiality of patients and patient
2information.

3(v)  Aid prescribers in identifying at-risk
4individuals and referring them to drug addiction
5treatment professionals and programs.

6(vi)  Refer prescription monitoring information to
7law enforcement or the appropriate licensing board in the
8Department of State.

9(vii)  Train, educate and instruct prescribers and
10dispensers on the use of the system.

11(viii)  Permit individuals employed by prescribers
12and dispensers to query the program as designees.

13(ix)  Keep pace with technological advances that
14facilitate the interoperability of the program with other
15states' prescription drug monitoring programs and
16electronic health information systems.

17(x)  Evaluate the costs and benefits of the program.

18(xi)  Convene the advisory group at least annually.

19(xii)  Operate and maintain the program on a daily
20basis.

21(xiii)  Review the program for the purpose of
22compiling statistics, research and educational materials
23and outreach.

24Section 6.  Establishment of program.

25(a)  General rule.--The board shall establish and oversee and
26the department shall administer the Achieving Better Care by
27Monitoring All Prescriptions Program.

28(b)  Program components.--This program shall:

29(1)  Provide an electronic web-based data system of
30controlled substances prescribed and dispensed in this

1Commonwealth.

2(2)  Be easily accessible by prescribers, dispensers and
3patients.

4(3)  Provide training and support for those using the
5data system.

6(4)  Contain processes for prescribers to refer patients
7to substance abuse treatment.

8(5)  Contain processes for referral of prescribers,
9dispensers or patients to law enforcement or the appropriate
10licensing board if necessary.

11(c)  Program queries.--The program shall maintain a record of
12database queries that contains all of the following:

13(1)  Identification of each person who requests or
14receives information from the database.

15(2)  Information provided to each person.

16(3)  Date and time the information is requested and
17provided.

18(d)  Record retention.--The board shall remove from the
19program all identifying information more than seven years old
20from the date of collection. The information shall be destroyed
21unless a law enforcement agency or a professional licensing or
22certification agency or board for prescribers or dispensers has
23submitted a written request to the department for retention of
24specific information. All requests shall comply with procedures
25adopted by the board.

26(e)  Good cause exception.--The program shall contain a good
27cause exception for dispensers and prescribers who are unable to
28submit the required data electronically and shall allow for the
29manual submission of data if the dispenser or prescriber does
30not have Internet access.

1Section 7.  Requirements for dispensers.

2(a)  Submission.--A dispenser shall, according to the format
3determined by the board, electronically submit information to
4the program regarding each controlled substance dispensed.

5(b)  Data elements.--All of the following information shall
6be provided by a dispenser:

7(1)  Full name of the prescriber.

8(2)  Prescriber Drug Enforcement Agency (DEA)
9registration number.

10(3)  Date prescription was written.

11(4)  Date prescription was dispensed.

12(5)  Full name, date of birth, gender and address of the
13person for whom the prescription was written and dispensed.

14(6)  The National Drug Code.

15(7)  Drug name and strength.

16(8)  Dosage quantity and days' supply.

17(9)  Dispenser's name, employer, DEA registration number
18and National Provider Identifier.

19(10)  Method of payment for the prescription.

20(c)  Frequency.--A dispenser shall submit all information
21required under subsection (b) to the program no later than 72
22hours after dispensing a controlled substance.

23Section 8.  Requirements for prescribers.

24(a)  Program query.--A prescriber shall query the program:

25(1)  for each new patient for purposes of establishing a
26base line and a thorough medical record; and

27(2) if a prescriber believes or has reason to believe,
28using sound clinical judgment, that a patient may be abusing
29or diverting drugs.

30(b)  Medical record entries.--A prescriber shall indicate the

1information obtained from the program in the patient's medical
2record if:

3(1) the individual is a new patient; or

4(2) the prescriber determines a drug should not be
5prescribed or furnished to a patient based upon the
6information from the program.

7(c)  Prescriber designee.--Prescribers may designate
8employees for purposes of accessing the program according to
9standards established by the board.

10Section 9.  Access to prescription information.

11(a)  Confidentiality.--Except as set forth in subsection (b),
12prescription information submitted to the program and records of
13requests to query the data shall be confidential and not subject
14to disclosure under the act of February 14, 2008 (P.L.6, No.3),
15known as the Right-to-Know Law.

16(b)  Authorized users.--The following individuals may query
17the program according to procedures determined by the board and
18with the following limitations:

19(1) Prescribers may query the program for:

20(i)  an existing patient; and

21(ii)  prescriptions written using the prescriber's
22own Drug Enforcement Agency number.

23(2) Dispensers may query the program for a current
24patient to whom the dispenser is dispensing or considering
25dispensing any controlled substance

26(3) Federal and State law enforcement officials may
27query the program for:

28(i)  schedule II controlled substances as indicated
29in the act of April 14, 1972 (P.L.233, No.64), known as
30The Controlled Substance, Drug, Device and Cosmetic Act

1and in the manner determined by the Pennsylvania Attorney
2General pursuant to 28 Pa. Code § 25.131 (relating to
3every dispensing practitioner); and

4(ii) all other schedules as long as a search warrant
5is provided.

6(4)  A grand jury may query the program investigating a
7criminal violation of a law governing controlled substances.

8(5)  Approved department personnel may query the program
9for the purpose of:

10(i)  conducting internal reviews related to
11controlled substance laws; or

12(ii)  engaging in the analysis of controlled
13substance prescription information as part of the
14assigned duties and responsibilities of employment.

15(6) Designated representatives from the Commonwealth or
16out-of-State agency or board responsible for licensing or
17certifying prescribers or dispensers whose professional
18practice was or is regulated by that agency or board for the
19purpose of conducting administrative investigations or
20proceedings.

21(7) Personnel from the Department of Public Welfare
22engaged in the administration of the medical assistance
23program.

24(8)  Personnel from the Insurance Department engaged in
25the administration of the Children's Health Insurance Program
26(CHIP).

27(9)  Personnel from the Department of Aging engaged in
28the administration of the Pharmaceutical Assistance Contract
29for the Elderly (PACE) and the Pharmaceutical Assistance
30Contract for the Elderly Needs Enhancement Tier (PACENET)

1programs.

2(10)  A medical examiner or county coroner for the
3purpose of investigating the death of the individual being
4queried.

5(11)  A prescription drug monitoring official of a state
6with which this Commonwealth has an interoperability
7agreement.

8(12)  Upon providing evidence of identity and within six
9months from the date of the request, an individual who is the
10recipient of a controlled substance prescription entered into
11the program, the individual's parent or guardian if the
12individual is under 18 years of age or the individual's
13health care power of attorney.

14Section 10.  Unlawful acts and penalties.

15(a) Unlawful acts.--A person commits a misdemeanor of the
16third degree if the person:

17(1)  Knowingly or intentionally releases, publishes or
18otherwise makes available the information from the program
19for purposes other than those specified in section 8.

20(2)  Obtains or attempts to obtain information from the
21program for purposes other than those specified in section 8
22or by misrepresentation or fraud.

23(b)  Civil violations.--

24(1)  Knowing, intentional and negligent release or use of
25information from the program shall be subject to a civil
26penalty of not less than $2,500 for each offense.

27(2)  Other civil penalties shall be assessed in
28accordance with department regulations.

29(c)  Collection of penalties.--The department shall be
30entitled to reasonable attorney fees and costs for successful

1collection actions and may:

2(1)  Collect any penalty imposed under this section and
3which is not paid by bringing an action in the court of
4common pleas of the county in which the person owing the debt
5resides or in the county where the department is located.

6(2)  Seek legal assistance from the Attorney General,
7the county or the district attorney of the county in which
8the action is brought to collect the penalty.

9(d)  Additional sanctions.--A prescriber or dispenser
10violating provisions of this act shall also be subject to
11sanctions under the prescriber's or dispenser's professional
12practice acts and by the appropriate licensing boards.

13Section 11.  Program funding.

14(a)  General rule.--The department may use the money
15deposited in the General Fund and appropriated to the department
16to carry out the requirements of this act.

17(b)  Civil penalties.--All civil penalties assessed under
18this act shall be deposited in the General Fund and appropriated
19to the department to implement the program.

20(c)  Data fees.--All costs associated with recording and
21submitting data shall be assumed by the submitting dispenser.

22(d)  Other funding opportunities.--The board may direct the
23department to pursue Federal funding and grants, both public and
24private.

25(e)  Fees prohibited.--A dispenser or prescriber shall not be
26required to pay a fee or tax specifically dedicated to the
27establishment, operation or maintenance of the program.

28(f)  Transfer of funds.--Any funds currently appropriated
29shall be redirected and used for the operation of the program.
30Additional agencies utilizing the system, including licensing

1boards, may also transfer funds to the department for operation
2of the program.

3Section 12.  Admissibility.

4(a)  Use of data.--Except as provided in subsection (b), data
5provided to, maintained in or accessed from the program that may
6be identified to, or with a particular individual is not subject
7to discovery, subpoena or similar compulsory process in any
8civil, judicial, administrative or legislative proceeding, nor
9shall any individual or organization with lawful access to the
10data be compelled to testify with regard to the data.

11(b)  Exceptions.--The restrictions in subsection (a) do not
12apply to:

13(1)  a criminal proceeding; or

14(2) a civil, judicial or administrative action brought
15to enforce the provisions of this act.

16Section 13.  Annual report.

17Within two years of the effective date of this act and
18annually thereafter, the board shall submit a report to the
19General Assembly. The report shall also be made available on the
20department's publicly accessible Internet website and shall
21include all of the following:

22(1)  The number of times the program has been legally and
23illegally accessed.

24(2)  The rate by which prescribers are utilizing the
25program.

26(3)  Any impact on prescribing practices for controlled
27substances.

28(4)  The cost effectiveness of the frequency of data
29submission.

30(5)  The effectiveness of the interoperability with other

1states and electronic medical records.

2(6) Other information as determined by the board.

3Section 14.  Regulations.

4The department shall promulgate regulations to implement the
5provisions of this act.

6Section 15.  Concurrent jurisdiction.

7The Attorney General shall have concurrent prosecutorial
8jurisdiction with the county district attorney for violations of
9this act.

10Section 16.  Effective date.

11This act shall take effect as follows:

12(1) Section 4 of the act shall take effect in 90 days.

13(2) This section shall take effect immediately.

14(3) The remainder of this act shall take effect June 30,
152015.