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.<-

1Section 13 <-12. Annual report.

2Section 14 <-13. Regulations.

3Section 15 <-14. Concurrent jurisdiction.

4secti<-on 39. EXPIRATION.

5Section 16 40<-. Effective date.

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

8Section 1. Short title.

9This act shall be known and may be cited as the Achieving
10Better Care by Monitoring All Prescriptions Program (ABC-MAP)
11Act.

12Section 2.  Purpose.

13This act is intended to increase the quality of patient care
14by giving prescribers and dispensers access to a patient's
<-15prescriptive prescription medication history through an
16electronic <-data system that will alert medical professionals to
17potential dangers for purposes of making treatment
18determinations. The act further intends that patients will have
19a thorough and easily obtainable record of <-their prescriptions
20for purposes of making educated and thoughtful health care
21decisions. Additionally, the act seeks to aid regulatory and law
22enforcement agencies in the detection and prevention of fraud,
23drug abuse and the criminal diversion of controlled substances.

24Section 3.  Definitions.

25The following words and phrases when used in this act shall
26have the meanings given to them in this section unless the
27context clearly indicates otherwise:

28"Addiction specialist." A physician licensed by the State
29Board of Medicine and certified by the American Board of
30Addiction Medicine.

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

2"Controlled substance."  A drug, substance or immediate
3precursor included in the act of April 14, 1972 (P.L.233,
4No.64), known as The Controlled Substance, Drug, Device and
5Cosmetic Act, or the Controlled Substances Act (Public Law 91-
6513, 84 Stat. 1236).

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

8"Dispense."  To deliver a controlled substance, other drug or
9device to a patient by or pursuant to the lawful order of a
10prescriber.

11"Dispenser."  A person lawfully authorized to dispense in
12this Commonwealth, including mail order and Internet sales of
13pharmaceuticals. The term does not include any of the following:

14(1)  A licensed health care facility that distributes the 
15controlled substance for the purpose of administration in the 
16licensed health care facility.

17(2)  A correctional facility or its contractors if the
18confined person cannot lawfully visit a prescriber outside
19the correctional facility without being escorted by a
20corrections officer.

21(3)  An authorized person who administers a controlled
22substance, other drug or device.

23(4)  A wholesale distributor of a controlled substance.

24(5)  A licensed provider in the LIFE program.

25(6)  A provider of hospice as defined in the act of July
2619, 1979 (P.L.130, No.48), known as the Health Care
27Facilities Act.

28(7)  A prescriber at a <-licensed health care facility
<-29licensed by this Commonwealth if the quantity of controlled
30substances dispensed is limited to an amount adequate to

1treat the patient for a maximum of <-24 hours with not more 
2than two 24-hour cycles within any 15-day period <-five days 
3and does not allow for a refill.

4(8)  A veterinarian.

5"Licensed health care facility."  A health care facility that
6is licensed under Article X of the act of June 13, 1967 (P.L.31,
7No.21), known as the Public Welfare Code, or the act of July 19,
81979 (P.L.130, No.48), known as the Health Care Facilities Act.

9"LIFE program."  The program of medical and supportive
10services known as Living Independently For Elders.

<-11"Pharmacy." As defined in the act of September 27, 1961 
12(P.L.1700, No.699), known as the Pharmacy Act.

13"Prescriber."  A person who is licensed, registered or
14otherwise lawfully authorized to distribute, dispense or to
15administer a controlled substance, other drug or device in the
16course of professional practice or research in this
17Commonwealth. The term does not include a veterinarian.

18"Program."  The Achieving Better Care by Monitoring All
19Prescriptions Program (ABC-MAP) <-created established in section
206.

<-21"System." The program's electronic prescription monitoring
22system with a database component.

23Section 4.  ABC-MAP Board.

24(a)  Creation.--The ABC-MAP Board is created in the
25Department of Health. <-The board shall establish the program. The 
26department shall operate the program by performing budgetary, 
27accounting, procurement and other support services as directed 
28by the board.

29(b)  Board composition.--The board shall consist of the
30following individuals or their designees:

1(1)  <-The Secretary of Health, who shall serve as
2chairperson.

3(2)  The Secretary of <-Public Welfare Human Services.

4(3)  <-The Secretary of Drug and Alcohol Programs.

5(4)  <-The Secretary of State.

6(5)  The Insurance Commissioner.

7(6)  <-The Secretary of Aging.

8(7)  The Commissioner of <-the Pennsylvania State Police.

9(8)  The Attorney General.

10(9) The Physician General, if the Secretary of Health is
11not a physician.

12(c)  Term limits.--Each member of the board shall serve for
13the duration of their elected or appointed position.

14(d)  Meetings.--The board shall meet at least once a year for
15the purpose of assessing the costs and benefits of the program
16and effectuating any necessary changes. The board may meet more
17frequently at the discretion of the chairperson.

18Section 5.  Powers and duties of board.

19The board shall have the following powers and duties:

20(1)  Evaluate and secure a vendor of an electronic
21prescription monitoring system for the purpose of carrying
22out the provisions of this act.

23(2)  Appoint an advisory group comprised of dispensers,
24prescribers, law enforcement <-officials, addiction
25specialists, patient and privacy advocates and individuals
26with expertise considered important to the operation of the
27program. All members shall have <-unique varying perspectives
28and will provide input and recommendations to the board
29regarding the establishment and maintenance of the program.
30The advisory group shall not exceed <-twelve 12 members.

1(3) Provide Create a written notice <-to be used by 
2prescribers and used or displayed by dispensers to provide 
3notice to patients that information regarding prescriptions 
4for controlled substances is being collected by the <-ABC-MAP 
5program and that the patient has a right to <-annually review 
6and correct the information <-at no charge to the patient. The 
7manner of notice may be determined by the board with the 
8advice of the advisory group <-with the program. The notice 
9must include all of the following:

10(i) The manner in which the patient may access the
11patient's personal information <-using a form or online 
12access. <-The notice shall state that one-time annual 
<-13quarterly patient access shall be at no cost.

14(ii) An explanation of the program and the program's
15authorized users.

16(iii) <-Record The program's record retention
17policies.

18(iv) An explanation that prescription information is 
19confidential and is not subject to the act of February 
2014, 2008 (P.L.6, No.3), known as the Right-to-Know Law.

<-21(v) Any cost associated with accessing the
22information more than once <-annually during each calendar
23quarter.

24(4)  Phase in an enforcement process so that dispensers
25and prescribers may transition and have adequate time to make
26the necessary changes to their operating systems.

27(5)  Develop protocols and policies <-and procedures to:

28(i)  Require more frequent reporting of <-data 
<-29prescription medication information under section 7
30should technology permit and so long as there is little

1or no fiscal impact to the Commonwealth or those
2reporting <-required to report. Any change in the frequency
3of reporting shall be made in collaboration with the
4Board of Pharmacy and the Board of Pharmacy's members to
5ensure that a pharmacy is able to accommodate the change.

6(ii)  Evaluate the information in the <-program system.

7(iii)  Allow for authorized department personnel to
8conduct internal reviews, analyses and interpret <-program 
9data <-the data contained in the system.

10(iv)  Safeguard the release of information to
11authorized users and department personnel and ensure the
12privacy and confidentiality of patients and patient
13information.

14(v)  Aid prescribers in identifying at-risk
15individuals and referring them to drug addiction
16treatment professionals and programs.

17(vi) Establish professionally developed criteria, 
18with the advice of the advisory group<-, that generates 
19referrals of prescription monitoring information to the 
20appropriate licensing board in the Department of State<-. 
<-21only A referral may only be generated when the system 
22produces an alert that there is a pattern of irregular 
23data <-deviating for a dispenser or prescriber which 
24appears to deviate from the clinical standard.

25(vii)  <-Train, educate and instruct Provide training 
26to prescribers and dispensers on the use of the system.

<-27(viii) Assist professional organizations whose
28members prescribe, monitor or treat patients or dispense
29controlled substances to patients to develop educational
30programs for those members relating to prescribing

1practices, pharmacology, controlled substance abuse and
<-2clinical standards, including identification of those at 
3risk for controlled substance abuse and referral and 
4treatment options for patients. <-clinical standards,
5including:

6(A) identification of those at risk for controlled
7substance abuse; and

8(B) referral and treatment options for patients.

<-9(viii) (ix)  Permit individuals employed by
10prescribers<-, pharmacies and dispensers to query the
11program system as designees <-so long as each individual 
12designee has a unique identifier when accessing the 
<-13database system and set explicit standards to qualify
14individuals authorized to query the <-program system and to
15ensure the security of the system when used by a 
16designee.

<-17(ix) (x)  Keep pace with technological advances that
18facilitate the interoperability of the <-program system
19with other states' prescription drug monitoring <-programs 
<-20systems and electronic health information systems.

<-21(x) (xi)  Evaluate the costs and benefits of the
22program.

<-23(xi) (xii)  Convene the advisory group at least
24annually.

<-25(xii) (xiii)  Direct the department to operate and
26maintain the program on a daily basis.

<-27(xiii) (xiv)  Review the program for the purpose of
28compiling statistics, research and educational materials
29and outreach.

<-30(xv) Identify a any controlled substance that has

1been shown to have limited or no potential for abuse and
2therefore should not be reported to the program.

3Section 6.  Establishment of program.

4(a)  General rule.--The board shall establish and oversee <-and 
5the department shall administer the Achieving Better Care by 
6Monitoring All Prescriptions Program. <-the program. The 
7department shall administer the program by performing budgetary, 
8accounting, procurement and other support services as directed 
9by the board.

10(b)  Program components.--<-This The program shall:

11(1)  Provide an electronic <-data system of controlled
12substances prescribed and dispensed in this Commonwealth.

13(2)  Be easily accessible by prescribers, dispensers and
14patients.

<-15(3) Provide an accessible website, including forms that 
16can be used by a patient to request a copy of or access to
<-17where a patient may electronically request or download a form
18to request a copy of the patient's program record.

<-19(3) (4)  Provide training and support for those using the
<-20data system.

<-21(4) (5)  Contain processes for prescribers to refer
22patients to substance abuse treatment.

23(c)  <-Program System queries.--The program shall maintain a
24record of <-database system queries that contains all of the
25following:

26(1)  <-Identification The identity of each person who
27requests or receives information from the <-database system.

28(2)  <-Information The information provided to each person 
<-29who requests or receives information from the database 
<-30system.

1(3)  <-Date The date and time the information is requested
2and provided.

3(d)  Record retention.--The board shall remove from the
4program system all identifying information more than <-three seven
5years old from the date of collection. The information shall be
6destroyed unless a law enforcement agency or a professional
7licensing or certification agency or board for prescribers or
8dispensers has submitted a written request to the department for
9retention of specific information for cause. The information may 
10be kept for an additional period of one year and all requests
11shall comply with procedures adopted by the board. The
12department may not grant more than two extensions regarding the
13retention of the same identified specific information <-unless 
14required to do so by court order.

15(e)  Good cause exception.--The program shall contain a good
16cause exception for dispensers and prescribers who are unable to
17submit the required data electronically and shall allow for the
18manual submission of data if the dispenser or prescriber does
19not have Internet access.

20(f) Expiration.--Current pharmacy reporting requirements to
21the Attorney General shall expire and shall no longer be
22enforceable upon the full implementation of the program. <-Any 
23data that has been reported to the Office of Attorney General 
24pursuant to 28 Pa. Code § 25.131 (relating to every dispensing 
25practitioner) that satisfies the retention requirements of 
26subsection (d) shall be transferred to the program.

27Section 7.  Requirements for dispensers <-and pharmacies.

28(a)  Submission.--A dispenser <-or pharmacy shall, according to
29the format determined by the board, electronically submit
30information to the <-program system regarding each controlled

1substance dispensed.

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

4(1)  <-Full The full name of the prescriber.

5(2)  <-Prescriber The prescriber's Drug Enforcement Agency
6(DEA) registration number.

7(3)  <-Date The date the prescription was written.

8(4)  <-Date The date the prescription was dispensed.

9(5)  <-Full The full name, date of birth, gender and
10address of the person for whom the prescription was written
11and dispensed.

12(6)  The National Drug Code.

13(7)  <-Dosage quantity and days' Quantity and Days' supply.

14(8) <-The DEA registration number and National Provider
15Identifier <-of the dispenser or pharmacy.

16(9)  <-Method The method of payment for the prescription.

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

<-20(d) Dispenser designee.--Dispensers may designate other
21pharmacy employees for purposes of accessing the <-program system
22according to standards established by the board.

23Section 8.  Requirements for prescribers.

24(a)  <-Program System query.--A prescriber shall query the
25program <-system:

26(1)  for each patient the first time the patient is 
27prescribed a controlled substance by the prescriber for
28purposes of establishing a base line and a thorough medical
29record; <-and or

30(2) if a prescriber believes or has reason to believe,

1using sound clinical judgment, that a patient may be abusing
2or diverting drugs.

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

6(1) the individual is a new patient; or

7(2) the prescriber determines a drug should not be
8prescribed or furnished to a patient based upon the
9information from the <-program system.

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

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

<-22(e) Immunity.--A prescriber or dispenser who has submitted
23or received information from the <-program system in accordance
24with this section and section 7, and has held the information in
25confidence as required by section 9, shall not be held civilly
26liable or disciplined in a licensing board action for submitting
27the information or not seeking or obtaining information from the
<-28program system prior to prescribing or dispensing a controlled
29substance.

30Section 9.  Access to prescription information.

1(a)  Confidentiality.--Except as set forth in subsection (b),
2prescription information submitted to the <-program system and
3records of requests to query the <-data system shall be
4confidential and not subject to disclosure under the act of
5February 14, 2008 (P.L.6, No.3), known as the Right-to-Know Law.

6(b)  Authorized users.--The following individuals may query
7the <-program system according to procedures determined by the
8board and with the following limitations:

9(1) Prescribers may query the <-program system for:

10(i)  an existing patient; and

11(ii)  prescriptions written using the prescriber's
12own Drug Enforcement Agency number.

13(2) Dispensers may query the <-program system for a
14current patient to whom the dispenser is dispensing or
15considering dispensing any controlled substance.

16(3) (i) <-Federal and State law enforcement officials may 
17query the program for: <-The Office of Attorney General 
18shall query the <-program system on behalf of all law 
19enforcement agencies, including, but not limited to, the 
20Office of the Attorney General and Federal, State and 
21local law enforcement agencies for:

22(A) Schedule II controlled substances as 
23indicated in the act of April 14, 1972 (P.L.233, 
24No.64), known as The Controlled Substance, Drug, 
25Device and Cosmetic Act and in the manner determined 
26by the Pennsylvania Attorney General pursuant to 28 
27Pa. Code § 25.131 (relating to every dispensing 
28practitioner); and

29(B) all other schedules upon receipt of a court
30order <-obtained by the requesting law enforcement
 

1agency. Upon receipt of a motion under this clause,
2the court may enter an ex parte order granting the
3motion if the law enforcement agency has demonstrated
4by a preponderance of the evidence that:

5(I) the motion pertains to a person who is
6the subject of an active criminal investigation
7with a reasonable likelihood of securing an
8arrest or prosecution in the foreseeable future;
9and

10(II) there is reasonable suspicion that a
11criminal act has occurred.

12(ii) Data obtained <-under this paragraph may by a law 
13enforcement agency under this paragraph shall only be 
14used <-by a law enforcement official to establish probable 
15cause to obtain a search warrant or arrest warrant.

<-16(iii) Requests made to the Office of Attorney
17General to query the <-program system under this paragraph
18shall be made in a form or manner prescribed by the
19Office of Attorney General and shall include the court
20order, when applicable. <-Each individual designee of the
21Office of Attorney General shall have a unique identifier
22when accessing the <-database system.

23(4)  <-A The Office of Attorney General shall query the 
24program system on behalf of a grand jury <-may query the 
25program if investigating a criminal violation of a law
26governing controlled substances.

27(5)  Approved department personnel may query the <-program 
<-28system for the purpose of:

29(i)  conducting internal reviews related to
30controlled substance laws; or

1(ii)  engaging in the analysis of controlled
2substance prescription information as part of the
3assigned duties and responsibilities of employment.

4(6) Designated representatives from the Commonwealth or
5out-of-State agency or board responsible for licensing or
6certifying prescribers or dispensers whose professional
7practice was or is regulated by that agency or board for the
8purpose of conducting administrative investigations or
9proceedings.

<-10(7) Personnel from the Department of Public Welfare
11engaged in the administration of the medical assistance
12program.

13(8)  Personnel from the Insurance Department engaged in
14the administration of the Children's Health Insurance Program
15(CHIP).

16(9)  Personnel from the Department of Aging engaged in
17the administration of the Pharmaceutical Assistance Contract
18for the Elderly (PACE) and the Pharmaceutical Assistance
19Contract for the Elderly Needs Enhancement Tier (PACENET)
20programs.

<-21(7) Designated Commonwealth personnel who are
22responsible for the development and evaluation of quality
23improvement strategies, program integrity initiatives or
24conducting internal compliance reviews and data reporting for
25the medical assistance program, Children's Health Insurance
26Program (CHIP), Pharmaceutical Assistance Contract for the
27Elderly (PACE) or Pharmaceutical Assistance Contract for the
28Elderly Needs Enhancement Tier (PACENET).

29(8) Personnel from the Department of Drug and Alcohol
30Programs engaged in the administration of the Methadone Death

1and Incident Review Team.

<-2(10) (9)  A medical examiner or county coroner for the
3purpose of investigating the death of the individual <-whose 
4record is being queried.

<-5(11) (10)  A prescription drug monitoring official,
6dispenser or prescriber of a state with which this
7Commonwealth has an interoperability agreement.

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

<-14(c) Access for active investigation.--In the case where a
15law enforcement agency has accessed the <-database system for an
16active investigation, the information about that query shall be
17withheld from the individual subject to the query for a period
18of six months after the conclusion of the investigation.

19Section 10.  Unlawful acts and penalties.

<-20(a) Unlawful acts.--A person commits a misdemeanor of the
21second degree if the person:

22(1)  Knowingly or intentionally releases, publishes or
23otherwise makes available the information from the program
24for purposes other than those specified in sections 8 and 9.

25(2)  Obtains or attempts to obtain information from the
26program for purposes other than those specified in sections 8
27and 9 or by misrepresentation or fraud.

<-28(a) Unlawful acts.--

29(1) A person commits a misdemeanor of the first degree
30if the person knowingly or intentionally obtains or attempts

1to obtain information from the <-program system for purposes
2other than those specified in section 8 or 9 or by
3misrepresentation or fraud.

4(2) A person commits a felony of the third degree if the
5person knowingly or intentionally releases, publishes, sells,
6transfers or otherwise makes available or attempts to
7release, publish, sell, transfer or otherwise make available
8the information from the <-program system for purposes other
9than those specified in sections 8 and 9.

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

12(c)  Civil violations.--

13(1)  Knowing, intentional and negligent release or use of
14information from the <-program system shall be subject to a
15civil penalty of not less than $2,500 for each offense.

16(2)  Other civil penalties shall be assessed in
17accordance with department regulations.

18(d)  Collection of penalties.--The department <-shall be 
19entitled to reasonable attorney fees and costs for successful 
20collection actions and may:

21(1)  Collect any penalty imposed under this section and
22which is not paid by bringing an action in the court of
23common pleas of the county in which the person owing the debt
24resides or in the county where the department is located.

25(2)  Seek legal assistance from the Attorney General,
26the county or the district attorney of the county in which
27the action is brought to collect the penalty.

28(e)  Additional sanctions.--A prescriber or dispenser
29violating provisions of this act shall also be subject to
30sanctions under the prescriber's or dispenser's professional

1practice acts and by the appropriate licensing boards.

2Section 11.  Program funding.

3(a)  General rule.--The department may use the money
4deposited in the General Fund and appropriated to the department
5to carry out the requirements of this act.

6(b)  Civil penalties.--All civil penalties assessed under
7this act shall be deposited in the General Fund and appropriated
8to the department to implement the program.

9(c)  Data fees.--All costs associated with recording and
10submitting data shall be assumed by the submitting dispenser.

11(d)  Other funding opportunities.--The board may direct the
12department to pursue Federal funding and grants, both public and
13private.

14(e)  Fees prohibited.--A dispenser or prescriber shall not be
15required to pay a fee or tax specifically dedicated to the
16establishment, operation or maintenance of the program. <-No fee 
17shall be assessed to the patient by the dispenser or prescriber 
18due to the need to submit information to the <-program system.

19(f)  Transfer of funds.--Any funds currently appropriated
20shall be redirected and used for the operation of the program.
21Additional agencies utilizing the system, including licensing
22boards, may also transfer funds to the department for operation
23of the program.

<-24Section 12.  Admissibility.

25(a)  Use of data.--Except as provided in subsection (b), data
26provided to, maintained in or accessed from the program that may
27be identified to, or with a particular individual is not subject
28to discovery, subpoena or similar compulsory process in any
29civil, judicial, administrative or legislative proceeding, nor
30shall any individual or organization with lawful access to the

1data be compelled to testify with regard to the data.

2(b)  Exceptions.--The restrictions in subsection (a) do not
3apply to:

4(1)  a criminal proceeding; or

5(2) a civil, judicial or administrative action brought
6to enforce the provisions of this act.

7Section <-13 12.  Annual report reports.

<-8(a) Board report.--Within two years of the effective date of
9this act and annually thereafter, the board shall submit a
10report to the General Assembly. The report shall also be made
11available on the department's publicly accessible Internet
12website and shall include all of the following:

13(1)  The number of times the <-program system has been
14legally and illegally accessed.

15(2)  The rate <-by at which prescribers are utilizing the
<-16program system.

17(3)  Any impact on prescribing practices for controlled
18substances.

19(4)  The cost effectiveness of the frequency of data
20submission.

21(5)  The effectiveness of the interoperability with other
22states and electronic medical records.

<-23(6) The number of law enforcement accesses via section
249(b)(3) and the number of search warrants issued as a result.

25(6) (7) Other information as determined by the bo<-ard.

26(b) Other report.--With<-in two years of the effective date of
27this act and annually thereafter, the Office of Attorney General
28in conjunction with law enforcement shall submit an annual
29report to the General Assembly.

30Section <-14 13.  Regulations.

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

3Section <-15 14.  Concurrent jurisdiction.

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

<-7Section 39. Expiration.

8This act shall expire June 30, 2022.

9Section <-16 15 40.  Effective date.

10This act shall take effect as follows:

11(1) Section 4 of <-the this act shall take effect in 90
12days.

13(2) This section shall take effect immediately.

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