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. Annual report.

2Section 14. Regulations.

3Section 15. Concurrent jurisdiction.

4Section 16. Effective date.

5The General Assembly of the Commonwealth of Pennsylvania
6hereby enacts as follows:

7Section 1. Short title.

8This act shall be known and may be cited as the Achieving
9Better Care by Monitoring All Prescriptions Program (ABC-MAP)
10Act.

11Section 2.  Purpose.

12This act is intended to increase the quality of patient care
13by giving prescribers and dispensers access to a patient's
14prescriptive history through an electronic data system that will
15alert medical professionals to potential dangers for purposes of
16making treatment determinations. The act further intends that
17patients will have a thorough and easily obtainable record of
18prescriptions for purposes of making educated and thoughtful
19health care decisions. Additionally, the act seeks to aid
20regulatory and law enforcement agencies in the detection and
21prevention of fraud, drug abuse and the criminal diversion of
22controlled substances.

23Section 3.  Definitions.

24The following words and phrases when used in this act shall
25have the meanings given to them in this section unless the
26context clearly indicates otherwise:

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

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

1"Controlled substance."  A drug, substance or immediate
2precursor included in the act of April 14, 1972 (P.L.233,
3No.64), known as The Controlled Substance, Drug, Device and
4Cosmetic Act, or the Controlled Substances Act (Public Law 91-
5513, 84 Stat. 1236).

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

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

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

13(1)  A licensed health care facility 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 <-licensed health care facility
<-28licensed by this Commonwealth if the quantity of controlled
29substances dispensed is limited to an amount adequate to
30treat the patient for a maximum of <-24 hours with not more
 

1than two 24-hour cycles within any 15-day period <-five days 
2and does not allow for a refill.

3(8)  A veterinarian.

4"Licensed health care facility."  A health care facility that
5is licensed under Article X of the act of June 13, 1967 (P.L.31,
6No.21), known as the Public Welfare Code, or the act of July 19,
71979 (P.L.130, No.48), known as the Health Care Facilities Act.

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

10"Prescriber."  A person who is licensed, registered or
11otherwise lawfully authorized to distribute, dispense or to
12administer a controlled substance, other drug or device in the
13course of professional practice or research in this
14Commonwealth. The term does not include a veterinarian.

15"Program."  The Achieving Better Care by Monitoring All
16Prescriptions Program (ABC-MAP) <-created established in section
176.

18Section 4.  ABC-MAP Board.

19(a)  Creation.--The ABC-MAP Board is created in the
20Department of Health. <-The board shall establish the program. The 
21department shall operate the program by performing budgetary, 
22accounting, procurement and other support services as directed 
23by the board.

24(b)  Board composition.--The board shall consist of the
25following individuals or their designees:

26(1)  Secretary of Health, who shall serve as chairperson.

27(2)  Secretary of Public Welfare.

28(3)  Secretary of Drug and Alcohol Programs.

29(4)  Secretary of State.

30(5)  The Insurance Commissioner.

1(6)  Secretary of Aging.

2(7)  The Commissioner of Pennsylvania State Police.

3(8)  The Attorney General.

4(9) The Physician General, if the Secretary of Health is
5not a physician.

6(c)  Term limits.--Each member of the board shall serve for
7the duration of their elected or appointed position.

8(d)  Meetings.--The board shall meet at least once a year for
9the purpose of assessing the costs and benefits of the program
10and effectuating any necessary changes. The board may meet more
11frequently at the discretion of the chairperson.

12Section 5.  Powers and duties of board.

13The board shall have the following powers and duties:

14(1)  Evaluate and secure a vendor of an electronic
15prescription monitoring system for the purpose of carrying
16out the provisions of this act.

17(2)  Appoint an advisory group comprised of dispensers,
18prescribers, law enforcement, addiction specialists, patient
19and privacy advocates and individuals with expertise
20considered important to the operation of the program. All
21members shall have unique perspectives and will provide input
22and recommendations to the board regarding the establishment
23and maintenance of the program. The advisory group shall not
24exceed twelve members.

25(3) Provide Create a written notice <-to be used by 
26prescribers and used or displayed by dispensers to provide 
27notice to patients that information regarding prescriptions 
28for controlled substances is being collected by the ABC-MAP 
29program and that the patient has a right to <-annually review 
30and correct the information <-at no charge to the patient. The
 

1manner of notice may be determined by the board with the 
2advice of the advisory group <-with the program. The notice 
3must include all of the following:

4(i) The manner in which the patient may access the
5patient's personal information <-using a form or online 
6access.

7(ii) An explanation of the program and the program's
8authorized users.

9(iii) Record retention policies.

10(iv) An explanation that prescription information is 
11confidential and is not subject to the act of February 
1214, 2008 (P.L.6, No.3), known as the Right-to-Know Law.

<-13(v) Any cost associated with accessing the
14information more than once annually.

15(4)  Phase in an enforcement process so that dispensers
16and prescribers may transition and have adequate time to make
17the necessary changes to their operating systems.

18(5)  Develop protocols and policies to:

19(i)  Require more frequent reporting of data should
20technology permit and so long as there is little or no
21fiscal impact to the Commonwealth or those reporting. Any
22change in the frequency of reporting shall be made in
23collaboration with the Board of Pharmacy and the Board of
24Pharmacy's members to ensure that a pharmacy is able to
25accommodate the change.

26(ii)  Evaluate the information in the program.

27(iii)  Allow for authorized department personnel to
28conduct internal reviews, analyses and interpret program
29data.

30(iv)  Safeguard the release of information to

1authorized users and department personnel and ensure the
2privacy and confidentiality of patients and patient
3information.

4(v)  Aid prescribers in identifying at-risk
5individuals and referring them to drug addiction
6treatment professionals and programs.

7(vi) Establish professionally developed criteria, 
8with the advice of the advisory group<-, that generates 
9referrals of prescription monitoring information to the 
10appropriate licensing board in the Department of State 
11only when the system produces an alert that there is a 
12pattern of irregular data <-deviating for a dispenser or 
13prescriber which appears to deviate from the clinical 
14standard.

15(vii)  Train, educate and instruct prescribers and
16dispensers on the use of the system.

<-17(viii) Assist professional organizations whose
18members prescribe, monitor or treat patients or dispense
19controlled substances to patients to develop educational
20programs for those members relating to prescribing
21practices, pharmacology, controlled substance abuse and
22clinical standards, including identification of those at
23risk for controlled substance abuse and referral and
24treatment options for patients.

<-25(viii) (ix)  Permit individuals employed by
26prescribers and dispensers to query the program as
27designees and set explicit standards to qualify
28individuals authorized to query the program and to ensure
29the security of the system when used by a designee.

<-30(ix) (x)  Keep pace with technological advances that

1facilitate the interoperability of the program with other
2states' prescription drug monitoring programs and
3electronic health information systems.

<-4(x) (xi)  Evaluate the costs and benefits of the
5program.

<-6(xi) (xii)  Convene the advisory group at least
7annually.

<-8(xii) (xiii)  Direct the department to operate and
9maintain the program on a daily basis.

<-10(xiii) (xiv)  Review the program for the purpose of
11compiling statistics, research and educational materials
12and outreach.

<-13(xv) Identify a controlled substance that has been
14shown to have limited or no potential for abuse and
15therefore should not be reported to the program.

16Section 6.  Establishment of program.

17(a)  General rule.--The board shall establish and oversee <-and 
18the department shall administer the Achieving Better Care by 
19Monitoring All Prescriptions Program. <-the program. The 
20department shall administer the program by performing budgetary, 
21accounting, procurement and other support services as directed 
22by the board.

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

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

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

<-28(3) Provide an accessible website, including forms that
29can be used by a patient to request a copy of or access to
30the patient's program record.

<-1(3) (4)  Provide training and support for those using the
2data system.

<-3(4) (5)  Contain processes for prescribers to refer
4patients to substance abuse treatment.

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 <-three seven 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 for cause. The information may 
19be kept for an additional period of one year and all requests
20shall comply with procedures adopted by the board. The
21department may not grant more than two extensions regarding the
22retention of the same identified specific information <-unless 
23required to do so by court order.

24(e)  Good cause exception.--The program shall contain a good
25cause exception for dispensers and prescribers who are unable to
26submit the required data electronically and shall allow for the
27manual submission of data if the dispenser or prescriber does
28not have Internet access.

29(f) Expiration.--Current pharmacy reporting requirements to
30the Attorney General shall expire and shall no longer be

1enforceable upon the full implementation of the program. <-Any 
2data that has been reported to the Office of Attorney General 
3pursuant to 28 Pa. Code § 25.131 (relating to every dispensing 
4practitioner) that satisfies the retention requirements of 
5subsection (d) shall be transferred to the program.

6Section 7.  Requirements for dispensers.

7(a)  Submission.--A dispenser shall, according to the format
8determined by the board, electronically submit information to
9the program regarding each controlled substance dispensed.

10(b)  Data elements.--All of the following information shall
11be provided by a dispenser:

12(1)  Full name of the prescriber.

13(2)  Prescriber Drug Enforcement Agency (DEA)
14registration number.

15(3)  Date prescription was written.

16(4)  Date prescription was dispensed.

17(5)  Full name, date of birth, gender and address of the
18person for whom the prescription was written and dispensed.

19(6)  The National Drug Code.

20(7)  <-Dosage quantity and days' Days' supply.

21(8) DEA registration number and National Provider
22Identifier <-of the dispenser or pharmacy.

23(9)  Method of payment for the prescription.

24(c)  Frequency.--A dispenser shall submit all information
25required under subsection (b) to the program no later than 72
26hours after dispensing a controlled substance.

<-27(d) Dispenser designee.--Dispensers may designate employees
28for purposes of accessing the program according to standards
29established by the board.

30Section 8.  Requirements for prescribers.

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

2(1)  for each patient the first time the patient is 
3prescribed a controlled substance by the prescriber for
4purposes of establishing a base line and a thorough medical
5record; <-and or

6(2) if a prescriber believes or has reason to believe,
7using sound clinical judgment, that a patient may be abusing
8or diverting drugs.

9(b)  Medical record entries.--A prescriber shall indicate the
10information obtained from the program in the patient's medical
11record if:

12(1) the individual is a new patient; or

13(2) the prescriber determines a drug should not be
14prescribed or furnished to a patient based upon the
15information from the program.

16(c)  Prescriber designee.--Prescribers may designate
17employees for purposes of accessing the program according to
18standards established by the board. In assigning a designee, a
19prescriber shall give preference to a professional nurse
20licensed by the State Board of Nursing.

21(d) Nonviolation.--A prescriber or dispenser who, using a
22sound standard of care in the exercise of clinical judgment,
23does not believe that a patient is abusing or diverting
24controlled substances shall not be in violation of this act for
25not seeking or obtaining information from the program prior to
26prescribing or dispensing so long as the prescriber or dispenser
27is otherwise in compliance.

<-28(e) Immunity.--A prescriber or dispenser who has submitted
29or received information from the program in accordance with this
30section and section 7, and has held the information in

1confidence as required by section 9, shall not be held civilly
2liable or disciplined in a licensing board action for submitting
3the information or not seeking or obtaining information from the
4program prior to prescribing or dispensing a controlled
5substance.

6Section 9.  Access to prescription information.

7(a)  Confidentiality.--Except as set forth in subsection (b),
8prescription information submitted to the program and records of
9requests to query the data shall be confidential and not subject
10to disclosure under the act of February 14, 2008 (P.L.6, No.3),
11known as the Right-to-Know Law.

12(b)  Authorized users.--The following individuals may query
13the program according to procedures determined by the board and
14with the following limitations:

15(1) Prescribers may query the program for:

16(i)  an existing patient; and

17(ii)  prescriptions written using the prescriber's
18own Drug Enforcement Agency number.

19(2) Dispensers may query the program for a current
20patient to whom the dispenser is dispensing or considering
21dispensing any controlled substance.

22(3) (i) <-Federal and State law enforcement officials may 
23query the program for: <-The Office of Attorney General 
24shall query the program on behalf of all law enforcement 
25agencies, including, but not limited to, the Office of 
26the Attorney General and Federal, State and local law 
27enforcement agencies for:

28(A) Schedule II controlled substances as 
29indicated in the act of April 14, 1972 (P.L.233, 
30No.64), known as The Controlled Substance, Drug,
 

1Device and Cosmetic Act and in the manner determined 
2by the Pennsylvania Attorney General pursuant to 28 
3Pa. Code § 25.131 (relating to every dispensing 
4practitioner); and

5(B) all other schedules upon receipt of a court
6order <-obtained by the requesting law enforcement 
7agency. Upon receipt of a motion under this clause,
8the court may enter an ex parte order granting the
9motion if the law enforcement agency has demonstrated
10by a preponderance of the evidence that:

11(I) the motion pertains to a person who is
12the subject of an active criminal investigation
13with a reasonable likelihood of securing an
14arrest or prosecution in the foreseeable future;
15and

16(II) there is reasonable suspicion that a
17criminal act has occurred.

18(ii) Data obtained <-under this paragraph may by a law 
19enforcement agency under this paragraph shall only be 
20used <-by a law enforcement official to establish probable 
21cause to obtain a search warrant or arrest warrant.

<-22(iii) Requests made to the Office of Attorney
23General to query the program under this paragraph shall
24be made in a form or manner prescribed by the Office of
25Attorney General and shall include the court order, when
26applicable.

27(4)  <-A The Office of Attorney General shall query the 
28program on behalf of a grand jury <-may query the program if 
29investigating a criminal violation of a law governing
30controlled substances.

1(5)  Approved department personnel may query the program
2for the purpose of:

3(i)  conducting internal reviews related to
4controlled substance laws; or

5(ii)  engaging in the analysis of controlled
6substance prescription information as part of the
7assigned duties and responsibilities of employment.

8(6) Designated representatives from the Commonwealth or
9out-of-State agency or board responsible for licensing or
10certifying prescribers or dispensers whose professional
11practice was or is regulated by that agency or board for the
12purpose of conducting administrative investigations or
13proceedings.

<-14(7) Personnel from the Department of Public Welfare
15engaged in the administration of the medical assistance
16program.

17(8)  Personnel from the Insurance Department engaged in
18the administration of the Children's Health Insurance Program
19(CHIP).

20(9)  Personnel from the Department of Aging engaged in
21the administration of the Pharmaceutical Assistance Contract
22for the Elderly (PACE) and the Pharmaceutical Assistance
23Contract for the Elderly Needs Enhancement Tier (PACENET)
24programs.

<-25(7) Designated Commonwealth personnel who are
26responsible for the development and evaluation of quality
27improvement strategies, program integrity initiatives or
28conducting internal compliance reviews and data reporting for
29the medical assistance program, Children's Health Insurance
30Program (CHIP), Pharmaceutical Assistance Contract for the

1Elderly (PACE) or Pharmaceutical Assistance Contract for the
2Elderly Needs Enhancement Tier (PACENET).

3(8) Personnel from the Department of Drug and Alcohol
4Programs engaged in the administration of the Methadone Death
5and Incident Review Team.

<-6(10) (9)  A medical examiner or county coroner for the
7purpose of investigating the death of the individual being
8queried.

<-9(11) (10)  A prescription drug monitoring official,
10dispenser or prescriber of a state with which this
11Commonwealth has an interoperability agreement.

<-12(12) (11)  Upon providing evidence of identity and within
1330 days from the date of the request, an individual who is
14the recipient of a controlled substance prescription entered
15into the program, the individual's parent or guardian if the
16individual is under 18 years of age or the individual's
17health care power of attorney.

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 for purposes other

1than 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 for purposes other than
8those 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 shall be subject to a civil
14penalty 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.

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.

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

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

14(2)  The rate by which prescribers are utilizing the
15program.

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) Other information as determined by the board.

23Section <-14 13.  Regulations.

24The department shall promulgate regulations to implement the
25provisions of this act.

26Section <-15 14.  Concurrent jurisdiction.

27The Attorney General shall have concurrent prosecutorial
28jurisdiction with the county district attorney for violations of
29this act.

30Section <-16 15.  Effective date.

1This act shall take effect as follows:

2(1) Section 4 of <-the this act shall take effect in 90
3days.

4(2) This section shall take effect immediately.

5(3) The remainder of this act shall take effect June 30,
62015.