NOTICE OF INTENT

Department of Health and Hospitals

Board of Pharmacy

Prescription Monitoring Program (LAC 46:LIII.2901,2909, 2911, 2913, 2917, 2921, 2925 and 2931)

In accordance with the provisions of the Administrative Procedure Act (R.S. 49:950 et seq.) and the Pharmacy Practice Act (R.S. 37:1161 et seq.), the Louisiana Board of Pharmacy hereby gives notice of its intent to amend LAC 46:LIII, Chapter 29, Prescription Monitoring Program, for the purpose of implementing the provisions of Acts 144 and 488 of the 2010 Regular Session of the Louisiana Legislature and Act 352 of the 2012 Regular Session of the Louisiana Legislature.

Title 46

PROFESSIONAL AND OCCUPATIONAL STANDARDS

Part LIII. Pharmacists

Chapter 29. Prescription Monitoring Program

Subchapter A. General Operations

§2901. Definitions

A. As used in this Chapter, the following terms shall have the meaning ascribed to them unless the context clearly indicates otherwise.

* * *

Dispenser-a person authorized by this state to dispense or distribute to the ultimate user any controlled substance or drug monitored by the program, but shall not include any of the following:

a. - d. …

e. a veterinarian who dispenses negligible amounts of controlled substances or drugs of concern, as identified by rule.

* * *

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1345 (July 2007), amended LR 36:755 (April 2010), effective September 1, 2010, LR 38:

§2909. Advisory Council

A. The advisory council shall consist of the following members, each of whom may appoint a designee:

1. - 4. …

5. The president of the Louisiana State Board of Veterinary Medicine;

6. - 25. …

26. The president of the Louisiana Veterinary Medical Association.

B. - C.6. …

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1005.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), amended LR 38:

Subchapter B. Data Collection

§2911. Reporting of Prescription Monitoring Information

A. …

B. Each dispenser shall submit the required information by electronic means as soon as possible but in no event more than seven days after the date of dispensing.

C. …

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), amended LR 38:

§2913. Required Data Elements

A. The information submitted for each prescription shall include data relative to the identification of the following elements of the transaction, or alternative data as identified in the board's program user manual. To the extent possible, the data shall be transmitted in the format established by the American Society for Automation in Pharmacy (ASAP) Telecommunications Format for Prescription Monitoring Programs Standard Version 4.2 or a successor.

1. Prescriber information:

a. last and first name of prescriber;

b. United States Drug Enforcement Administration (DEA) registration number, and suffix if applicable, or in the alternative, the national provider identifier (NPI) number, as issued by the United States Centers for Medicare and Medicaid Services (CMS).

2. Patient information:

a. last and first name of human patient and middle initial or name if available, or in the event of a veterinary prescription, the client's name and patient's animal species;

b. complete address of patient;

c. - d. …

e. gender code;

f. species code.

3. Prescription information:

a. - c. …

d. number of refills authorized on original prescription and refill number;

e. …

4. Drug information:

a. …

b. quantity dispensed;

c. days supply;

5. Dispenser information:

a. DEA registration number, or in the alternative, the national provider identifier (NPI) number.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), amended LR 38:

Subchapter C. Access to Prescription Monitoring Information

§2917. Authorized Direct Access Users of Prescription Monitoring Information

A. The following persons may access prescription monitoring information in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar protected health information under federal and state law and regulation:

1. persons authorized to prescribe or dispense controlled substances or drugs of concern for the purpose of providing medical or pharmaceutical care for their patients, or for verifying their prescription records;

2. designated representatives from the professional licensing, certification, or regulatory agencies of this state or another state charged with administrative oversight of those professionals engaged in the prescribing or dispensing of controlled substances or other drugs of concern;

3. - 4. …

5. prescription monitoring programs located in other states, through a secure interstate data exchange system or health information exchange system approved by the board, but only in compliance with the provisions of R.S. 40:1007.G.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1347 (July 2007), amended LR 38:

§2921. Methods of Access to Prescription Monitoring Information

A. Prescribers and dispensers, once properly registered, may solicit prescription monitoring information from the program concerning their patients, or for verifying their prescription records. The program may require such users to certify the legitimacy of their inquiry prior to furnishing the requested information.

B. - D. …

E. Upon receipt of one of the following methods of application by local, state, out-of-state, or federal law enforcement or prosecutorial officials, the program may provide prescription monitoring information:

E.1. - G. …

H. Prescription monitoring programs located in other states may access prescription monitoring information from the program through a secure interstate data exchange system or health information exchange system approved by the board.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1347 (July 2007), amended LR 38:

Subchapter D. Reports

§2925. Release of Prescription Monitoring Information to Other Entities

A. The program shall provide prescription monitoring information to public or private entities, whether located in or outside the state, for public research, policy, or educational purposes, but only after removing information that identifies or could reasonably be used to identify prescribers, dispensers, and individual patients or persons who received prescriptions from prescribers.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1348 (July 2007), amended LR 38:

Subchapter E. Exemptions

§2931. Exemptions

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1348 (July 2007), repealed LR 38:

Family Impact Statement

In accordance with Section 953 of Title 49 of the Louisiana Revised Statutes, there is hereby submitted a Family Impact Statement on the Rule proposed for adoption, repeal, or amendment.

1. The effect on the stability of the family. We can discern no effect on the stability of the family.

2. The effect on the authority and rights of parents regarding the education and supervision of their children. We can discern no effect on the authority and rights of parents regarding the education and supervision of their children.

3. The effect on the functioning of the family. We can discern no effect on the functioning of the family.

4. The effect on family earnings and family budget. We can discern no effect on family earnings or family budget.

5. The effect on the behavior and personal responsibility of children. We can discern no effect on the behavior and personal responsibility of children.

6. The ability of the family or a local government to perform the function as contained in the proposed Rule. We can discern no effect on the ability of the family or a local government to perform the activity as contained in the proposed Rule.

Public Comments

Interested persons may submit written comments to Malcolm J. Broussard, Executive Director, Louisiana Board of Pharmacy, 3388 Brentwood Drive, Baton Rouge, LA 70809-1700. He is responsible for responding to inquiries regarding these proposed amendments.

Public Hearing

A public hearing on these proposed amendments is scheduled for Monday, August 27, 2012 at 9 a.m. in the board office. At that time, all interested persons will be afforded an opportunity to submit data, views, or arguments, either orally or in writing. The deadline for the receipt of all comments is 12 noon that same day.

Malcolm J. Broussard
Executive Director

FISCAL AND ECONOMIC IMPACT STATEMENT FOR ADMINISTRATIVE RULES

RULE TITLE: Prescription Monitoring Program

I. ESTIMATED IMPLEMENTATION COSTS (SAVINGS) TO STATE OR LOCAL GOVERNMENT UNITS (Summary)

It is estimated that implementation of the proposed rule will cost the agency $40,500 in FY 13. These costs consist of $500 for printing expenses and $40,000 for software modification to connect to the national prescription monitoring program (PMP) network in order to participate in the interstate exchange of prescription monitoring information as directed by Act 352 of 2012 and Act 488 of 2010. In addition, continuing network participation fees are estimated to cost approximately $15,000 annually in future fiscal years.

II. ESTIMATED EFFECT ON REVENUE COLLECTIONS OF STATE OR LOCAL GOVERNMENTAL UNITS (Summary)

With this rule change, the Board will repeal the exemption of veterinarians from the prescription monitoring program under section 2931. As such, the Board estimates increased revenue collections of a minimum of $22,500 per fiscal year from the assessment of the $25 annual fee from the approximately 900 veterinarians currently holding a controlled dangerous substance license.

III. ESTIMATED COSTS AND/OR ECONOMIC BENEFITS TO DIRECTLY AFFECTED PERSONS OR NONGOVERNMENTAL GROUPS (Summary)

Veterinarians will now be required to pay the annual $25 PMP fee. In addition, to the extent that Louisiana licensed pharmacies may need to upgrade their pharmacy dispensing information systems, some pharmacies may incur programming costs of an indeterminable amount to prepare their information systems to continue to report their eligible controlled substance dispensing transactions to the PMP database.

IV. ESTIMATED EFFECT ON COMPETITION AND EMPLOYMENT (Summary)

No effect on competition and employment is anticipated as a result of this rule change.