AN ACT

 

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

5TABLE OF CONTENTS

6Section 1. Short title.

7Section 2. Purpose.

8Section 3. Definitions.

9Section 4. 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"Addiction specialist." A physician licensed by the State
27Board of Medicine and certified by the American Board of
28Addiction Medicine.

29"Board."  The ABC-MAP Board established in section 4.

30"Controlled substance."  A drug, substance or immediate

1precursor included in the act of April 14, 1972 (P.L.233,
2No.64), known as The Controlled Substance, Drug, Device and
3Cosmetic Act, or the Controlled Substances Act (Public Law 91-
4513, 84 Stat. 1236).

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

6"Dispense."  To deliver a controlled substance, other drug or
7device to a patient by or pursuant to the lawful order of a
8prescriber.

9"Dispenser."  A person lawfully authorized to dispense in
10this Commonwealth, including mail order and Internet sales of
11pharmaceuticals. The term does not include any of the following:

12(1)  A licensed health care facility that distributes the 
13controlled substance for the purpose of administration in the 
14licensed health care facility.

15(2)  A correctional facility or its contractors if the
16confined person cannot lawfully visit a prescriber outside
17the correctional facility without being escorted by a
18corrections officer.

19(3)  An authorized person who administers a controlled
20substance, other drug or device.

21(4)  A wholesale distributor of a controlled substance.

22(5)  A licensed provider in the LIFE program.

23(6)  A provider of hospice as defined in the act of July
2419, 1979 (P.L.130, No.48), known as the Health Care
25Facilities Act.

26(7)  A prescriber at a health care facility licensed by
27this Commonwealth if the quantity of controlled substances
28dispensed is limited to an amount adequate to treat the
29patient for a maximum of 24 hours with not more than two 24-
30hour cycles within any 15-day period.

1(8)  A veterinarian.

2"Licensed health care facility."  A health care facility that
3is licensed under Article X of the act of June 13, 1967 (P.L.31,
4No.21), known as the Public Welfare Code, or the act of July 19,
51979 (P.L.130, No.48), known as the Health Care Facilities Act.

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

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

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

15Section 4.  ABC-MAP Board.

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

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

23(1)  Secretary of Health, who shall serve as chairperson.

24(2)  Secretary of Public Welfare.

25(3)  Secretary of Drug and Alcohol Programs.

26(4)  Secretary of State.

27(5)  The Insurance Commissioner.

28(6)  Secretary of Aging.

29(7)  The Commissioner of Pennsylvania State Police.

30(8)  The Attorney General.

1(9) The Physician General, if the Secretary of Health is
2not a physician.

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

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

9Section 5.  Powers and duties of board.

10The board shall have the following powers and duties:

11(1)  Evaluate and secure a vendor of an electronic
12prescription monitoring system for the purpose of carrying
13out the provisions of this act.

14(2)  Appoint an advisory group comprised of dispensers,
15prescribers, law enforcement, addiction specialists, patient
16and privacy advocates and individuals with expertise
17considered important to the operation of the program. All
18members shall have unique perspectives and will provide input
19and recommendations to the board regarding the establishment
20and maintenance of the program. The advisory group shall not
21exceed twelve members.

22(3) Provide <-written notice to patients that information 
23regarding prescriptions for controlled substances is being 
24collected by the ABC-MAP program and that the patient has a 
25right to annually review and correct the information at no 
26charge to the patient. The manner of notice may be determined 
27by the board with the advice of the advisory group. <-The 
28notice must include all of the following:

29(i) The manner in which the patient may access the
30patient's personal information using a form or online

1access.

2(ii) An explanation of the program and the program's
3authorized users.

4(iii) Record retention policies.

5(iv) An explanation that prescription information is 
6confidential and is not subject to the act of February 
714, 2008 (P.L.6, No.3), known as the Right-to-Know Law.

8(4)  Phase in an enforcement process so that dispensers
9and prescribers may transition and have adequate time to make
10the necessary changes to their operating systems.

11(5)  Develop protocols and policies to:

12(i)  Require more frequent reporting of data should
13technology permit and so long as there is little or no
14fiscal impact to the Commonwealth or those reporting. Any
15change in the frequency of reporting shall be made in
16collaboration with the Board of Pharmacy and the Board of
17Pharmacy's members to ensure that a pharmacy is able to
18accommodate the change.

19(ii)  Evaluate the information in the program.

20(iii)  Allow for authorized department personnel to
21conduct internal reviews, analyses and interpret program
22data.

23(iv)  Safeguard the release of information to
24authorized users and department personnel and ensure the
25privacy and confidentiality of patients and patient
26information.

27(v)  Aid prescribers in identifying at-risk
28individuals and referring them to drug addiction
29treatment professionals and programs.

30(vi) Establish professionally developed criteria,
 

1with the advice of the advisory group that generates 
2referrals of prescription monitoring information to the 
3appropriate licensing board in the Department of State 
4only when the system produces an alert that there is a 
5pattern of irregular data deviating from the clinical 
6standard.

7(vii)  Train, educate and instruct prescribers and
8dispensers on the use of the system.

9(viii)  Permit individuals employed by prescribers
10and dispensers to query the program as designees and set
11explicit standards to <-qualify individuals authorized to 
12query the program and to ensure the security of the
13system when <-a designee is indicated used by a designee.

14(ix)  Keep pace with technological advances that
15facilitate the interoperability of the program with other
16states' prescription drug monitoring programs and
17electronic health information systems.

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

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

20(xii)  Direct the department to operate and maintain
21the program on a daily basis.

22(xiii)  Review the program for the purpose of
23compiling statistics, research and educational materials
24and outreach.

25Section 6.  Establishment of program.

26(a)  General rule.--The board shall establish and oversee and
27the department shall administer the Achieving Better Care by
28Monitoring All Prescriptions Program.

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

30(1)  Provide an electronic data system of controlled

1substances prescribed and dispensed in this Commonwealth.

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(c)  Program queries.--The program shall maintain a record of
9database queries that contains all of the following:

10(1)  Identification of each person who requests or
11receives information from the database.

12(2)  Information provided to each person.

13(3)  Date and time the information is requested and
14provided.

15(d)  Record retention.--The board shall remove from the
16program all identifying information more than three years old
17from the date of collection. The information shall be destroyed
18unless a law enforcement agency or a professional licensing or
19certification agency or board for prescribers or dispensers has
20submitted a written request to the department for retention of
21specific information for cause. The information may be kept for
22an additional period of one year and all requests shall comply
23with procedures adopted by the board. The department may not
24grant more than two extensions regarding the retention of the
25same identified specific information.

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.

1(f) Expiration.--Current pharmacy reporting requirements to
2the Attorney General shall expire and shall no longer be
3enforceable upon the full implementation of the program.

4Section 7.  Requirements for dispensers.

5(a)  Submission.--A dispenser shall, according to the format
6determined by the board, electronically submit information to
7the program regarding each controlled substance dispensed.

8(b)  Data elements.--All of the following information shall
9be provided by a dispenser:

10(1)  Full name of the prescriber.

11(2)  Prescriber Drug Enforcement Agency (DEA)
12registration number.

13(3)  Date prescription was written.

14(4)  Date prescription was dispensed.

15(5)  Full name, date of birth, gender and address of the
16person for whom the prescription was written and dispensed.

17(6)  The National Drug Code.

18(7)  Dosage quantity and days' supply.

19(8) DEA registration number and National Provider
20Identifier.

21(9)  Method of payment for the prescription.

22(c)  Frequency.--A dispenser shall submit all information
23required under subsection (b) to the program no later than 72
24hours after dispensing a controlled substance.

25Section 8.  Requirements for prescribers.

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

27(1)  for each patient the first time the patient is 
28prescribed a controlled substance by the prescriber for
29purposes of establishing a base line and a thorough medical
30record; and

1(2) if a prescriber believes or has reason to believe,
2using sound clinical judgment, that a patient may be abusing
3or diverting drugs.

4(b)  Medical record entries.--A prescriber shall indicate the
5information obtained from the program in the patient's medical
6record if:

7(1) the individual is a new patient; or

8(2) the prescriber determines a drug should not be
9prescribed or furnished to a patient based upon the
10information from the program.

11(c)  Prescriber designee.--Prescribers may designate
12employees for purposes of accessing the program according to
13standards established by the board. In assigning a designee, a
14prescriber shall give preference to a professional nurse
15licensed by the State Board of Nursing.

16(d) Nonviolation.--A prescriber or dispenser who, using a
17sound standard of care in the exercise of clinical judgment,
18does not believe that a patient is abusing or diverting
19controlled substances shall not be in violation of this act for
20not seeking or obtaining information from the program prior to
21prescribing or dispensing so long as the prescriber or dispenser
22is otherwise in compliance.

23Section 9.  Access to prescription information.

24(a)  Confidentiality.--Except as set forth in subsection (b),
25prescription information submitted to the program and records of
26requests to query the data shall be confidential and not subject
27to disclosure under the act of February 14, 2008 (P.L.6, No.3),
28known as the Right-to-Know Law.

29(b)  Authorized users.--The following individuals may query
30the program according to procedures determined by the board and

1with the following limitations:

2(1) Prescribers may query the program for:

3(i)  an existing patient; and

4(ii)  prescriptions written using the prescriber's
5own Drug Enforcement Agency number.

6(2) Dispensers may query the program for a current
7patient to whom the dispenser is dispensing or considering
8dispensing any controlled substance.

9(3) (i) Federal and State law enforcement officials may 
10query the program for:

11(A) Schedule II controlled substances as 
12indicated in the act of April 14, 1972 (P.L.233, 
13No.64), known as The Controlled Substance, Drug, 
14Device and Cosmetic Act and in the manner determined 
15by the Pennsylvania Attorney General pursuant to 28 
16Pa. Code § 25.131 (relating to every dispensing 
17practitioner); and

18(B) all other schedules upon receipt of a court
19order. Upon receipt of a motion under this clause,
20the court may enter an ex parte order granting the
21motion if the law enforcement agency has demonstrated
22by a preponderance of the evidence that:

23(I) the motion pertains to a person who is
24the subject of an active criminal investigation
25with a reasonable likelihood of securing an
26arrest or prosecution in the foreseeable future;
27and

28(II) there is reasonable suspicion that a
29criminal act has occurred.

30(ii) Data obtained under this paragraph may only be
 

1used by a law enforcement official to establish probable 
2cause to obtain a search warrant or arrest warrant.

3(4)  A grand jury may query the program if investigating
4a criminal violation of a law governing controlled
5substances.

6(5)  Approved department personnel may query the program
7for the purpose of:

8(i)  conducting internal reviews related to
9controlled substance laws; or

10(ii)  engaging in the analysis of controlled
11substance prescription information as part of the
12assigned duties and responsibilities of employment.

13(6) Designated representatives from the Commonwealth or
14out-of-State agency or board responsible for licensing or
15certifying prescribers or dispensers whose professional
16practice was or is regulated by that agency or board for the
17purpose of conducting administrative investigations or
18proceedings.

19(7) Personnel from the Department of Public Welfare
20engaged in the administration of the medical assistance
21program.

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

25(9)  Personnel from the Department of Aging engaged in
26the administration of the Pharmaceutical Assistance Contract
27for the Elderly (PACE) and the Pharmaceutical Assistance
28Contract for the Elderly Needs Enhancement Tier (PACENET)
29programs.

30(10)  A medical examiner or county coroner for the

1purpose of investigating the death of the individual being
2queried.

3(11)  A prescription drug monitoring official, dispenser
4or prescriber of a state with which this Commonwealth has an
5interoperability agreement.

6(12)  Upon providing evidence of identity and within <-six 
7months <-30 days from the date of the request, an individual
8who is the recipient of a controlled substance prescription
9entered into the program, the individual's parent or guardian
10if the individual is under 18 years of age or the
11individual's health care power of attorney.

12Section 10.  Unlawful acts and penalties.

13(a) Unlawful acts.--A person commits a misdemeanor of the
14second degree if the person:

15(1)  Knowingly or intentionally releases, publishes or
16otherwise makes available the information from the program
17for purposes other than those specified in <-section 8 sections 
188 and 9.

19(2)  Obtains or attempts to obtain information from the
20program for purposes other than those specified in <-section 8 
<-21sections 8 and 9 or by misrepresentation or fraud.

22(b) Criminal violations.--Each violation under subsection
23(a) shall constitute a separate offense.

24(c)  Civil violations.--

25(1)  Knowing, intentional and negligent release or use of
26information from the program shall be subject to a civil
27penalty of not less than $2,500 for each offense.

28(2)  Other civil penalties shall be assessed in
29accordance with department regulations.

30(d)  Collection of penalties.--The department shall be

1entitled to reasonable attorney fees and costs for successful
2collection actions and may:

3(1)  Collect any penalty imposed under this section and
4which is not paid by bringing an action in the court of
5common pleas of the county in which the person owing the debt
6resides or in the county where the department is located.

7(2)  Seek legal assistance from the Attorney General,
8the county or the district attorney of the county in which
9the action is brought to collect the penalty.

10(e)  Additional sanctions.--A prescriber or dispenser
11violating provisions of this act shall also be subject to
12sanctions under the prescriber's or dispenser's professional
13practice acts and by the appropriate licensing boards.

14Section 11.  Program funding.

15(a)  General rule.--The department may use the money
16deposited in the General Fund and appropriated to the department
17to carry out the requirements of this act.

18(b)  Civil penalties.--All civil penalties assessed under
19this act shall be deposited in the General Fund and appropriated
20to the department to implement the program.

21(c)  Data fees.--All costs associated with recording and
22submitting data shall be assumed by the submitting dispenser.

23(d)  Other funding opportunities.--The board may direct the
24department to pursue Federal funding and grants, both public and
25private.

26(e)  Fees prohibited.--A dispenser or prescriber shall not be
27required to pay a fee or tax specifically dedicated to the
28establishment, operation or maintenance of the program.

29(f)  Transfer of funds.--Any funds currently appropriated
30shall be redirected and used for the operation of the program.

1Additional agencies utilizing the system, including licensing
2boards, may also transfer funds to the department for operation
3of the program.

4Section 12.  Admissibility.

5(a)  Use of data.--Except as provided in subsection (b), data
6provided to, maintained in or accessed from the program that may
7be identified to, or with a particular individual is not subject
8to discovery, subpoena or similar compulsory process in any
9civil, judicial, administrative or legislative proceeding, nor
10shall any individual or organization with lawful access to the
11data be compelled to testify with regard to the data.

12(b)  Exceptions.--The restrictions in subsection (a) do not
13apply to:

14(1)  a criminal proceeding; or

15(2) a civil, judicial or administrative action brought
16to enforce the provisions of this act.

17Section 13.  Annual report.

18Within two years of the effective date of this act and
19annually thereafter, the board shall submit a report to the
20General Assembly. The report shall also be made available on the
21department's publicly accessible Internet website and shall
22include all of the following:

23(1)  The number of times the program has been legally and
24illegally accessed.

25(2)  The rate by which prescribers are utilizing the
26program.

27(3)  Any impact on prescribing practices for controlled
28substances.

29(4)  The cost effectiveness of the frequency of data
30submission.

1(5)  The effectiveness of the interoperability with other
2states and electronic medical records.

3(6) Other information as determined by the board.

4Section 14.  Regulations.

5The department shall promulgate regulations to implement the
6provisions of this act.

7Section 15.  Concurrent jurisdiction.

8The Attorney General shall have concurrent prosecutorial
9jurisdiction with the county district attorney for violations of
10this act.

11Section 16.  Effective date.

12This act shall take effect as follows:

13(1) Section 4 of the act shall take effect in 90 days.

14(2) This section shall take effect immediately.

15(3) The remainder of this act shall take effect June 30,
162015.