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 
13patient 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 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.

30(3)  <-Date The date and time the information is requested

1and provided.

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

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

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

26Section 7.  Requirements for dispensers <-and pharmacies.

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

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

3(1)  <-Full The full name of the prescriber.

4(2)  <-Prescriber The prescriber's Drug Enforcement Agency
5(DEA) registration number.

6(3)  <-Date The date the prescription was written.

7(4)  <-Date The date the prescription was dispensed.

8(5)  <-Full The full name, date of birth, gender and
9address of the person for whom the prescription was written
10and dispensed.

11(6)  The National Drug Code.

12(7)  <-Dosage quantity and days' Days' supply.

13(8) <-The DEA registration number and National Provider
14Identifier <-of the dispenser or pharmacy.

15(9)  <-Method The method of payment for the prescription.

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

<-19(d) Dispenser designee.--Dispensers may designate other
20pharmacy employees for purposes of accessing the <-program system
21according to standards established by the board.

22Section 8.  Requirements for prescribers.

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

25(1)  for each patient the first time the patient is 
26prescribed a controlled substance by the prescriber for
27purposes of establishing a base line and a thorough medical
28record; <-and or

29(2) if a prescriber believes or has reason to believe,
30using sound clinical judgment, that a patient may be abusing

1or diverting drugs.

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

5(1) the individual is a new patient; or

6(2) the prescriber determines a drug should not be
7prescribed or furnished to a patient based upon the
8information from the <-program system.

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

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

<-21(e) Immunity.--A prescriber or dispenser who has submitted
22or received information from the <-program system in accordance
23with this section and section 7, and has held the information in
24confidence as required by section 9, shall not be held civilly
25liable or disciplined in a licensing board action for submitting
26the information or not seeking or obtaining information from the
<-27program system prior to prescribing or dispensing a controlled
28substance.

29Section 9.  Access to prescription information.

30(a)  Confidentiality.--Except as set forth in subsection (b),

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

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

8(1) Prescribers may query the <-program system for:

9(i)  an existing patient; and

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

12(2) Dispensers may query the <-program system for a
13current patient to whom the dispenser is dispensing or
14considering dispensing any controlled substance.

15(3) (i) <-Federal and State law enforcement officials may 
16query the program for: <-The Office of Attorney General 
17shall query the <-program system on behalf of all law 
18enforcement agencies, including, but not limited to, the 
19Office of the Attorney General and Federal, State and 
20local law enforcement agencies for:

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

28(B) all other schedules upon receipt of a court
29order <-obtained by the requesting law enforcement 
30agency. Upon receipt of a motion under this clause,

1the court may enter an ex parte order granting the
2motion if the law enforcement agency has demonstrated
3by a preponderance of the evidence that:

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

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

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

<-15(iii) Requests made to the Office of Attorney
16General to query the <-program system under this paragraph
17shall be made in a form or manner prescribed by the
18Office of Attorney General and shall include the court
19order, when applicable. <-Each individual designee of the
20Office of Attorney General shall have a unique identifier
21when accessing the database.

22(4)  <-A The Office of Attorney General shall query the 
23program system on behalf of a grand jury <-may query the 
24program if investigating a criminal violation of a law
25governing controlled substances.

26(5)  Approved department personnel may query the <-program 
<-27system for the purpose of:

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

30(ii)  engaging in the analysis of controlled

1substance prescription information as part of the
2assigned duties and responsibilities of employment.

3(6) Designated representatives from the Commonwealth or
4out-of-State agency or board responsible for licensing or
5certifying prescribers or dispensers whose professional
6practice was or is regulated by that agency or board for the
7purpose of conducting administrative investigations or
8proceedings.

<-9(7) Personnel from the Department of Public Welfare
10engaged in the administration of the medical assistance
11program.

12(8)  Personnel from the Insurance Department engaged in
13the administration of the Children's Health Insurance Program
14(CHIP).

15(9)  Personnel from the Department of Aging engaged in
16the administration of the Pharmaceutical Assistance Contract
17for the Elderly (PACE) and the Pharmaceutical Assistance
18Contract for the Elderly Needs Enhancement Tier (PACENET)
19programs.

<-20(7) Designated Commonwealth personnel who are
21responsible for the development and evaluation of quality
22improvement strategies, program integrity initiatives or
23conducting internal compliance reviews and data reporting for
24the medical assistance program, Children's Health Insurance
25Program (CHIP), Pharmaceutical Assistance Contract for the
26Elderly (PACE) or Pharmaceutical Assistance Contract for the
27Elderly Needs Enhancement Tier (PACENET).

28(8) Personnel from the Department of Drug and Alcohol
29Programs engaged in the administration of the Methadone Death
30and Incident Review Team.

<-1(10) (9)  A medical examiner or county coroner for the
2purpose of investigating the death of the individual <-whose 
3record is being queried.

<-4(11) (10)  A prescription drug monitoring official,
5dispenser or prescriber of a state with which this
6Commonwealth has an interoperability agreement.

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

<-13(c) Access for active investigation.--In the case where a
14law enforcement agency has accessed the database for an active
15investigation, the information about that query shall be
16withheld from the individual subject to the query for a period
17of six months after the conclusion of the investigation.

18Section 10.  Unlawful acts and penalties.

<-19(a) Unlawful acts.--A person commits a misdemeanor of the
20second degree if the person:

21(1)  Knowingly or intentionally releases, publishes or
22otherwise makes available the information from the program
23for purposes other than those specified in sections 8 and 9.

24(2)  Obtains or attempts to obtain information from the
25program for purposes other than those specified in sections 8
26and 9 or by misrepresentation or fraud.

<-27(a) Unlawful acts.--

28(1) A person commits a misdemeanor of the first degree
29if the person knowingly or intentionally obtains or attempts
30to obtain information from the <-program system for purposes

1other than those specified in section 8 or 9 or by
2misrepresentation or fraud.

3(2) A person commits a felony of the third degree if the
4person knowingly or intentionally releases, publishes, sells,
5transfers or otherwise makes available or attempts to
6release, publish, sell, transfer or otherwise make available
7the information from the <-program system for purposes other
8than those specified in sections 8 and 9.

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

11(c)  Civil violations.--

12(1)  Knowing, intentional and negligent release or use of
13information from the <-program system shall be subject to a
14civil penalty of not less than $2,500 for each offense.

15(2)  Other civil penalties shall be assessed in
16accordance with department regulations.

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

20(1)  Collect any penalty imposed under this section and
21which is not paid by bringing an action in the court of
22common pleas of the county in which the person owing the debt
23resides or in the county where the department is located.

24(2)  Seek legal assistance from the Attorney General,
25the county or the district attorney of the county in which
26the action is brought to collect the penalty.

27(e)  Additional sanctions.--A prescriber or dispenser
28violating provisions of this act shall also be subject to
29sanctions under the prescriber's or dispenser's professional
30practice acts and by the appropriate licensing boards.

1Section 11.  Program funding.

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

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

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

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

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

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

<-23Section 12.  Admissibility.

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

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

3(1)  a criminal proceeding; or

4(2) a civil, judicial or administrative action brought
5to enforce the provisions of this act.

6Section <-13 12.  Annual report reports.

<-7(a) Board report.--Within two years of the effective date of
8this act and annually thereafter, the board shall submit a
9report to the General Assembly. The report shall also be made
10available on the department's publicly accessible Internet
11website and shall include all of the following:

12(1)  The number of times the <-program system has been
13legally and illegally accessed.

14(2)  The rate <-by at which prescribers are utilizing the
<-15program system.

16(3)  Any impact on prescribing practices for controlled
17substances.

18(4)  The cost effectiveness of the frequency of data
19submission.

20(5)  The effectiveness of the interoperability with other
21states and electronic medical records.

<-22(6) The number of law enforcement accesses via section
239(b)(3) and the number of search warrants issued as a result.

24(6) (7) Other information as determined by the bo<-ard.

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

29Section <-14 13.  Regulations.

30The department shall promulgate regulations to implement the

1provisions of this act.

2Section <-15 14.  Concurrent jurisdiction.

3The Attorney General shall have concurrent prosecutorial
4jurisdiction with the county district attorney for violations of
5this act.

<-6Section 39. Expiration.

7This act shall expire June 30, 2022.

8Section <-16 15 40.  Effective date.

9This act shall take effect as follows:

10(1) Section 4 of <-the this act shall take effect in 90
11days.

12(2) This section shall take effect immediately.

13(3) The remainder of this act shall take effect June 30,
142015.