AN ACT

 

1Providing for prescription drug monitoring; creating the
<-2Prescription Drug Monitoring ABC-MAP 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 ABC-MAP 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 ABC-MAP Board
27established in 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 <-that distributes the 
14controlled substance for the purpose of administration in the 
15licensed health care facility.

16(2)  A correctional facility <-or its contractors if the
17confined person cannot lawfully visit a prescriber outside
18the correctional facility without being escorted by a
19corrections officer.

20(3)  An authorized person who administers a controlled
21substance, other drug or device.

22(4)  A wholesale distributor of a controlled substance.

23(5)  A licensed provider in the LIFE program.

24(6)  A provider of hospice as defined in <-the act of July
2519, 1979 (P.L.130, No.48), known as the Health Care
26Facilities Act.

27(7)  A prescriber at a health care facility licensed by
28this Commonwealth if the quantity of controlled substances
29dispensed is limited to an amount adequate to treat the
30patient for a maximum of 24 hours with not more than two 24-


1hour cycles within any 15-day period.

2(8)  A veterinarian.

3"Licensed health care facility."  A health care facility that
4is licensed under Article X of the act of June 13, 1967 (P.L.31,
5No.21), known as the Public Welfare Code, or the act of July 19,
61979 (P.L.130, No.48), known as the Health Care Facilities Act.

7"LIFE program."  The program of medical and supportive
8services known as Living Independently For Elders.

9"Prescriber."  A person who is licensed, registered or
10otherwise lawfully authorized to distribute, dispense or to
11administer a controlled substance, other drug or device in the
12course of professional practice or research in this
13Commonwealth. The term does not include a veterinarian.

14"Program."  The Achieving Better Care by Monitoring All
15Prescriptions Program (ABC-MAP) created in section 6.

16Section 4.  <-Prescription Drug Monitoring ABC-MAP Board.

17(a)  Creation.--The <-Prescription Drug Monitoring ABC-MAP
18Board is created in the Department of Health. The board shall
19administer establish the program. The department shall <-perform 
<-20operate the program by performing budgetary, accounting,
21procurement and other support services <-as directed by the board.

22(b)  Board composition.--The board shall consist of the
23following individuals or their designees:

24(1)  Secretary of Health, who shall serve as chairperson.

25(2)  Secretary of Public Welfare.

26(3)  Secretary of Drug and Alcohol Programs.

27(4)  Secretary of State.

28(5)  The Insurance Commissioner.

29(6)  Secretary of Aging.

30(7)  The Commissioner of Pennsylvania State Police.

1(8)  The Attorney General.

<-2(9) The Physician General, if the Secretary of Health is
3not a physician.

4(c)  Term limits.--Each member of the board shall serve for
5the duration of their elected or appointed position.

6(d)  Meetings.--The board shall meet at least once a year for
7the purpose of assessing the costs and benefits of the program
8and effectuating any necessary changes. <-The board may meet more 
9frequently at the discretion of the chairperson.

10Section 5.  Powers and duties of board.

11The board shall have the following powers and duties:

12(1)  Evaluate and secure a vendor of an electronic
13prescription monitoring system for the purpose of carrying
14out the provisions of this act.

15(2)  Appoint an advisory group comprised of dispensers,
16prescribers, law enforcement<-, patient and privacy advocates
17and individuals with expertise considered important to the
18operation of the program. All members shall have unique
19perspectives and will provide input and recommendations to
20the board regarding the establishment and maintenance of the
21program. The advisory group shall not exceed twelve members.

<-22(3)  Modify the list of required controlled substances to
23be reported based on the benefit to the citizens of this
24Commonwealth.

<-25(3) Provide notice to patients that information
26regarding prescriptions for controlled substances is being
27collected by the ABC-MAP program. The manner of notice may be
28determined by the board with the advice of the advisory
29group.

30(4)  Phase in an enforcement process so that dispensers

1and prescribers may transition and have adequate time to make
2the necessary changes to their operating systems.

3(5)  Develop protocols and policies to:

4(i)  Require more frequent reporting of data should
5technology permit and so long as there is little or no
6fiscal impact to the Commonwealth or those reporting. <-Any 
7change in the frequency of reporting shall be made in 
8collaboration with the Board of Pharmacy and the Board of 
9Pharmacy's members to ensure that a pharmacy is able to 
10accommodate the change.

11(ii)  Evaluate the information in the program.

12(iii)  Allow for authorized department personnel to
13conduct internal reviews, analyses and interpret program
14data.

15(iv)  Safeguard the release of information to
16authorized users and department personnel and ensure the
17privacy and confidentiality of patients and patient
18information.

19(v)  Aid prescribers in identifying at-risk
20individuals and referring them to drug addiction
21treatment professionals and programs.

<-22(vi)  Refer prescription monitoring information to
23law enforcement or the appropriate licensing board in the
24Department of State.

<-25(vi) Establish professionally developed criteria,
26with the advice of the advisory group that generates
27referrals of prescription monitoring information to law
28enforcement or the appropriate licensing board in the
29Department of State only if there is a pattern of
30irregular data deviating from the clinical standard.

1(vii)  Train, educate and instruct prescribers and
2dispensers on the use of the system.

3(viii)  Permit individuals employed by prescribers
4and dispensers to query the program as designees <-and set 
5explicit standards to ensure the security of the system 
6when a designee is indicated.

7(ix)  Keep pace with technological advances that
8facilitate the interoperability of the program with other
9states' prescription drug monitoring programs and
10electronic health information systems.

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

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

13(xii)  <-Operate Direct the department to operate and
14maintain the program on a daily basis.

15(xiii)  Review the program for the purpose of
16compiling statistics, research and educational materials
17and outreach.

18Section 6.  Establishment of program.

19(a)  General rule.--The board shall establish and oversee and
20the department shall administer the Achieving Better Care by
21Monitoring All Prescriptions Program.

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

23(1)  Provide an electronic web-based data system of
24controlled substances prescribed and dispensed in this
25Commonwealth.

26(2)  Be easily accessible by prescribers, dispensers and
27patients.

28(3)  Provide training and support for those using the
29data system.

30(4)  Contain processes for prescribers to refer patients

1to substance abuse treatment.

<-2(5)  Contain processes for referral of prescribers,
3dispensers or patients to law enforcement or the appropriate
4licensing board if necessary.

5(c)  Program queries.--The program shall maintain a record of
6database queries that contains all of the following:

7(1)  Identification of each person who requests or
8receives information from the database.

9(2)  Information provided to each person.

10(3)  Date and time the information is requested and
11provided.

12(d)  Record retention.--The board shall remove from the
13program all identifying information more than <-seven four years
14old from the date of collection. The information shall be
15destroyed unless a law enforcement agency or a professional
16licensing or certification agency or board for prescribers or
17dispensers has submitted a written request to the department for
18retention of specific information. <-All The information may be 
19kept for a period of one year and all requests shall comply with
20procedures adopted by the board.

21(e)  Good cause exception.--The program shall contain a good
22cause exception for dispensers and prescribers who are unable to
23submit the required data electronically and shall allow for the
24manual submission of data if the dispenser or prescriber does
25not have Internet access.

<-26(f) Expiration.--Current pharmacy reporting requirements to
27the Attorney General shall expire and shall no longer be
28enforceable upon the full implementation of the program.

29Section 7.  Requirements for dispensers.

30(a)  Submission.--A dispenser shall, according to the format

1determined by the board, electronically submit information to
2the program regarding each controlled substance dispensed.

3(b)  Data elements.--All of the following information shall
4be provided by a dispenser:

5(1)  Full name of the prescriber.

6(2)  Prescriber Drug Enforcement Agency (DEA)
7registration number.

8(3)  Date prescription was written.

9(4)  Date prescription was dispensed.

10(5)  Full name, date of birth, gender and address of the
11person for whom the prescription was written and dispensed.

12(6)  The National Drug Code.

<-13(7)  Drug name and strength.

14(8) <-(7)  Dosage quantity and days' supply.

<-15(9)  Dispenser's name, employer, (8) DEA registration
16number and National Provider Identifier.

<-17(10) (9)  Method of payment for the prescription.

18(c)  Frequency.--A dispenser shall submit all information
19required under subsection (b) to the program no later than 72
20hours after dispensing a controlled substance.

21Section 8.  Requirements for prescribers.

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

23(1)  for each <-new patient patient the first time the 
24patient is prescribed a controlled substance by the 
25prescriber for purposes of establishing a base line and a
26thorough 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.

<-10(d) Nonviolation.--A prescriber or dispenser who, using a
11sound standard of care in the exercise of clinical judgment,
12does not believe that a patient is abusing or diverting
13controlled substances shall not be in violation of this act for
14not seeking or obtaining information from the program prior to
15prescribing or dispensing so long as the prescriber or dispenser
16is otherwise in compliance.

17Section 9.  Access to prescription information.

18(a)  Confidentiality.--Except as set forth in subsection (b),
19prescription information submitted to the program and records of
20requests to query the data shall be confidential and not subject
21to disclosure under the act of February 14, 2008 (P.L.6, No.3),
22known as the Right-to-Know Law.

23(b)  Authorized users.--The following individuals may query
24the program according to procedures determined by the board and
25with the following limitations:

26(1) Prescribers may query the program for:

27(i)  an existing patient; and

28(ii)  prescriptions written using the prescriber's
29own Drug Enforcement Agency number.

30(2) Dispensers may query the program for a current

1patient to whom the dispenser is dispensing or considering
2dispensing any controlled substance

<-3(3) Federal and State law enforcement officials may
4query the program for:

5(i)  schedule II controlled substances as indicated

<-6(3) (i) Federal and State law enforcement officials may
7query the program for:

8(A) Schedule II controlled substances as 
9indicated in the act of April 14, 1972 (P.L.233, 
10No.64), known as The Controlled Substance, Drug, 
11Device and Cosmetic Act and in the manner determined 
12by the Pennsylvania Attorney General pursuant to 28 
13Pa. Code § 25.131 (relating to every dispensing 
14practitioner); and

<-15(ii) all other schedules as long as a search warrant
16is provided.

<-17(B) all other schedules upon receipt of a court
18order. Upon receipt of a motion under this clause,
19the court may enter an ex parte order granting the
20motion if the law enforcement agency has demonstrated
21by a preponderance of the evidence that:

22(I) the motion pertains to a person who is
23the subject of an active criminal investigation
24with a reasonable likelihood of securing an
25arrest or prosecution in the foreseeable future;
26and

27(II) there is reasonable suspicion that a
28criminal act has occurred.

29(ii) Data obtained under this paragraph may only be 
30used by a law enforcement official to establish probable
 

1cause to obtain a search warrant or arrest warrant.

2(4)  A grand jury may query the program <-if investigating
3a criminal violation of a law governing controlled
4substances.

5(5)  Approved department personnel may query the program
6for the purpose of:

7(i)  conducting internal reviews related to
8controlled substance laws; or

9(ii)  engaging in the analysis of controlled
10substance prescription information as part of the
11assigned duties and responsibilities of employment.

12(6) Designated representatives from the Commonwealth or
13out-of-State agency or board responsible for licensing or
14certifying prescribers or dispensers whose professional
15practice was or is regulated by that agency or board for the
16purpose of conducting administrative investigations or
17proceedings.

18(7) Personnel from the Department of Public Welfare
19engaged in the administration of the medical assistance
20program.

21(8)  Personnel from the Insurance Department engaged in
22the administration of the Children's Health Insurance Program
23(CHIP).

24(9)  Personnel from the Department of Aging engaged in
25the administration of the Pharmaceutical Assistance Contract
26for the Elderly (PACE) and the Pharmaceutical Assistance
27Contract for the Elderly Needs Enhancement Tier (PACENET)
28programs.

29(10)  A medical examiner or county coroner for the
30purpose of investigating the death of the individual being

1queried.

2(11)  A prescription drug monitoring official<-, dispenser 
3or prescriber of a state with which this Commonwealth has an
4interoperability agreement.

5(12)  Upon providing evidence of identity and within six
6months from the date of the request, an individual who is the
7recipient of a controlled substance prescription entered into
8the program, the individual's parent or guardian if the
9individual is under 18 years of age or the individual's
10health care power of attorney.

11Section 10.  Unlawful acts and penalties.

12(a) Unlawful acts.--A person commits a misdemeanor of the
13third degree if the person:

14(1)  Knowingly or intentionally releases, publishes or
15otherwise makes available the information from the program
16for purposes other than those specified in section 8.

17(2)  Obtains or attempts to obtain information from the
18program for purposes other than those specified in section 8
19or by misrepresentation or fraud.

20(b)  Civil violations.--

21(1)  Knowing, intentional and negligent release or use of
22information from the program shall be subject to a civil
23penalty of not less than $2,500 for each offense.

24(2)  Other civil penalties shall be assessed in
25accordance with department regulations.

26(c)  Collection of penalties.--The department shall be
27entitled to reasonable attorney fees and costs for successful
28collection actions and may:

29(1)  Collect any penalty imposed under this section and
30which is not paid by bringing an action in the court of

1common pleas of the county in which the person owing the debt
2resides or in the county where the department is located.

3(2)  Seek legal assistance from the Attorney General,
4the county or the district attorney of the county in which
5the action is brought to collect the penalty.

6(d)  Additional sanctions.--A prescriber or dispenser
7violating provisions of this act shall also be subject to
8sanctions under the prescriber's or dispenser's professional
9practice acts and by the appropriate licensing boards.

10Section 11.  Program funding.

11(a)  General rule.--The department may use the money
12deposited in the General Fund and appropriated to the department
13to carry out the requirements of this act.

14(b)  Civil penalties.--All civil penalties assessed under
15this act shall be deposited in the General Fund and appropriated
16to the department to implement the program.

17(c)  Data fees.--All costs associated with recording and
18submitting data shall be assumed by the submitting dispenser.

19(d)  Other funding opportunities.--The board may direct the
20department to pursue Federal funding and grants, both public and
21private.

22(e)  Fees prohibited.--A dispenser or prescriber shall not be
23required to pay a fee or tax specifically dedicated to the
24establishment, operation or maintenance of the program.

25(f)  Transfer of funds.--Any funds currently appropriated
26shall be redirected and used for the operation of the program.
27Additional agencies utilizing the system, including licensing
28boards, may also transfer funds to the department for operation
29of the program.

30Section 12.  Admissibility.

1(a)  Use of data.--Except as provided in subsection (b), data
2provided to, maintained in or accessed from the program that may
3be identified to, or with a particular individual is not subject
4to discovery, subpoena or similar compulsory process in any
5civil, judicial, administrative or legislative proceeding, nor
6shall any individual or organization with lawful access to the
7data be compelled to testify with regard to the data.

8(b)  Exceptions.--The restrictions in subsection (a) do not
9apply to:

10(1)  a criminal proceeding; or

11(2) a civil, judicial or administrative action brought
12to enforce the provisions of this act.

13Section 13.  Annual report.

14Within two years of the effective date of this act and
15annually thereafter, the board shall submit a report to the
16General Assembly. The report shall also be made available on the
17department's publicly accessible Internet website and shall
18include all of the following:

19(1)  The number of times the program has been legally and
20illegally accessed.

21(2)  The rate by which prescribers are utilizing the
22program.

23(3)  Any impact on prescribing practices for controlled
24substances.

25(4)  The cost effectiveness of the frequency of data
26submission.

27(5)  The effectiveness of the interoperability with other
28states and electronic medical records.

29(6) Other information as determined by the board.

30Section 14.  Regulations.

1The department shall promulgate regulations to implement the
2provisions of this act.

3Section 15.  Concurrent jurisdiction.

4The Attorney General shall have concurrent prosecutorial
5jurisdiction with the county district attorney for violations of
6this act.

7Section 16.  Effective date.

8This act shall take effect as follows:

9(1) Section 4 of the act shall take effect in 90 days.

10(2) This section shall take effect immediately.

11(3) The remainder of this act shall take effect June 30,
122015.