hb 1218

CHAPTER 281

HB 1218 - FINAL VERSION

AN ACT relative to the regulation of pharmacists and prescription drug orders, relative to the use of non-original containers to organize prescription and nonprescription drugs, and relative to the management of certain plan benefits under Medicaid by the department of health and human services.

SPONSORS: Rep. Millham, Belk 4

I. Allows the board of pharmacy to authorize and regulate the temporary absence of pharmacists from the pharmacy, the use of centralized prescription processing, the electronic transmission of prescriptions, and the filling of prescriptions by automated pharmacy systems.

II. Allows home health care or hospice agency nurses to organize a client's prescription and nonprescription drugs into non-original containers.

III. Authorizes the commissioner of health and human services to operate a program for managing plan benefits under Medicaid, provides that the department adopt interim rules concerning the program, and establishes a legislative oversight committee.

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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

Be it Enacted by the Senate and House of Representatives in General Court convened:

281:1 Pharmacy; Definitions; Prescription; Electronic Order Included. Amend RSA 318:1, XVI to read as follows:

XVI. "Prescription" means a verbal, or written, or facsimile or electronically transmitted order for drugs, medicines and devices by a licensed practitioner, to be compounded and dispensed by licensed pharmacists in a duly registered pharmacy, and to be kept on file for a period of 4 years. A written order shall include an electronic transmission prescription received and retained in a form complying with rules adopted pursuant to RSA 318:5-a, XV. Prescriptions may also apply to the finished products dispensed by the licensed pharmacist in the registered pharmacy, on order of a licensed practitioner as defined in this section.

281:2 Pharmacy; Definitions; Supervision. Amend RSA 318:1, XIX to read as follows:

XIX. "Supervision" means under the direct charge or direction and does not contemplate [~~any~~] absence of the person responsible for providing such supervision, except where permitted by rules of the board under RSA 318:5-a, XIV.

281:3 New Paragraphs; Definitions. Amend RSA 318:1 by inserting after paragraph XXI the following new paragraphs:

XXII. "Automated pharmacy system" means mechanical systems that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collects, controls, and maintains all transaction information.

XXIII. "Central prescription processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, drug utilization review, claims adjudication, refill authorizations, and therapeutic interventions.

XXIV. "Electronic transmission prescription" means both image transmissions of a prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber, and data transmissions of a prescription order, other than an electronic image transmission prescription, that is electronically transmitted by computer link, modem, or other computer communication device from a licensed prescriber to a pharmacy.

281:4 New Paragraphs; Board of Pharmacy; Rulemaking Authority. Amend RSA 318:5-a by inserting after paragraph XI the following new paragraphs:

XII. Procedures for the use, documentation, security, maintenance, and monitoring of automated pharmacy systems.

XIII. Standards for contracting, implementation, and operation of central prescription processing.

XIV. The adoption of protocols and procedures for the temporary absence of a pharmacist from a pharmacy while on duty.

XV. The requirements for the use of electronic transmission prescriptions, including the contents of such order and the verification of electronic signatures.

318:47-a Prescription Labels. Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he or she shall affix to the container in which such drug is dispensed a label showing at least the name and address of the pharmacy and the name or initials of the dispensing pharmacist or pharmacist-in-charge; the prescription identification number assigned by the pharmacy; the date dispensed; any directions as may be stated on the prescription; the name of the prescribing practitioner; the name of the patient; all pertinent auxiliary labels; and, unless otherwise indicated by the prescribing physician, dentist, veterinarian, or advanced registered nurse practitioner, the name, strength, and quantity of the drug dispensed. All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities. No person shall alter, deface, or remove any label so affixed.

281:6 Controlled Drug Act; Prescription Labels. Amend RSA 318-B:13, II to read as follows:

II. Whenever a pharmacist dispenses any controlled drug on prescription issued by a practitioner, he or she shall affix to the container in which such drug is dispensed a label showing the name, address, and registry number of the pharmacy and name or the initials of the pharmacist; the name of the prescribing practitioner; the prescription identification number; the name of the patient; the date dispensed; any directions as may be stated on the prescription; and the name and strength and quantity of the drug dispensed. All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities. No person shall alter, deface, or remove any label so affixed.

281:7 New Paragraph; Pharmacy; Dealing in or Possessing Prescription Drugs. Amend RSA 318:42 by inserting after paragraph XII the following new paragraph:

XIII. A nurse licensed under RSA 326-B, who is an employee of a home health care or hospice agency licensed pursuant to RSA 151:2 and is acting in the course of employment, from organizing the prescription and nonprescription drugs of clients into containers designed to aid clients in carrying out a prescriber's directions, provided that the organizing of drugs is documented in the client's nursing record and that the original prescription containers remain in the client's possession.

281:8 New Subparagraph; Controlled Drug Act; Non-Original Containers. Amend RSA 318-B:14, II by inserting after subparagraph (b) the following new subparagraph:

(c) A person may possess a controlled drug other than in the original container if the non-original container is a medication organizer designed to aid the person in carrying out the prescriber's directions and the non-original container was organized by a nurse licensed under RSA 326-B who is an employee of a home health care or hospice agency licensed pursuant to RSA 151:2, and who is acting in the course of employment, provided the original prescription containers remain in the person's possession.

281:9 Department of Health and Human Services; Medicaid Pharmacy Benefits Management Program.

I. The general court recognizes that there may be value to the Medicaid pharmacy benefits management program operated by the department of health and human services, but wants to provide both a full review of the program by the joint legislative committee on administrative rules and an opportunity for public comment on the specifics of the program.

II. The commissioner, in order to manage plan benefits under Medicaid, shall within 30 days of the effective date of this section adopt interim rules under RSA 541-A, and prior to their expiration, shall adopt rules under RSA 541-A, relative to a pharmacy benefits management program which may include provisions for:

(a) A medical pharmacy lock-in program to prevent recipients from obtaining excessive quantities of, or from inappropriately using, prescription drugs through multiple pharmacies; and

(b) A prior authorization process in which a prescriber seeks approval by the department, through its designated agent, to make payment for drugs which are considered to have a high potential for misuse or abuse, are high cost, or should be monitored for correct adherence to clinical protocols.

III.(a) The commissioner of health and human services shall establish a pharmacy and therapeutics committee to advise the department on the operation of the Medicaid pharmacy benefits management program, including the medications subject to prior authorization, the criteria for approving prior authorization including consideration of medical necessity, and the criteria for a pharmacy lock-in program designed to prevent recipients from obtaining excessive quantities of, or from inappropriately using, prescription drugs through multiple pharmacies.

(3) Four physicians nominated by the New Hampshire Medical Society, who shall be from the following specialties:

(4) Two pharmacists, one of whom shall be a Pharm.D, nominated by the New Hampshire Pharmacists Association.

(c) Persons nominated to the committee shall be subject to the approval of the commissioner. If the commissioner does not approve a nominee, the nominating entity shall submit additional nominees to the commissioner.

(d) In determining which medications shall be subject to prior authorization and in establishing the criteria for approving prior authorization or any changes thereto, the committee shall hold a public hearing to be scheduled at a time and place chosen to afford opportunity for the public to present its views. The committee shall give public notice of any hearing at least 30 days in advance of the hearing. Public notice shall include a public notice advertisement in a publication of daily statewide circulation.

IV.(a) The commissioner of health and human services shall report to the legislative oversight committee established in subparagraph (b) by November 1 of each year with respect to the Medicaid prescription drug benefits management program, including:

(1) The cost savings to the state realized during the current budget biennium from the institution of a prior authorization program;

(2) Any unintended costs in other Medicaid healthcare services programs, including long-term care admissions, hospital admissions, emergency room visits, and physician visits during the current budget biennium from the institution of a prior authorization program;

(3) A report on the volume of prior authorizations as a percentage of total claims, average call waiting time, and other issues that the state's pharmacy benefits administrator is required to comply with under the terms of the pharmacy benefits management contract;

(4) A report of the effectiveness of the department of health and human services' pharmacy lock-in program; and

(5) Recommendations for other opportunities to improve the management of pharmacy services or to expand pharmacy benefits to additional populations.

(b) For the purpose of legislative oversight of the Medicaid prescription drug benefits management program administered by the department, there is established a legislative oversight committee consisting of 3 members of the house of representatives appointed by the speaker and 3 senators appointed by the senate president. The committee shall meet as needed and shall elect a chairperson from among the members. The committee shall review the reports of the commissioner under subparagraph (a) and may request additional information as needed. The department shall provide to the oversight committee a report of actions taken by the pharmacy and therapeutics committee since the last meeting of the oversight committee, including a list of any medications made subject to prior authorization, the criteria for approving such prior authorization, and minutes of the pharmacy and therapeutics committee meetings. The oversight committee may request the assistance of the legislative budget assistant in auditing the program and in reviewing its performance and effectiveness. The committee may make recommendations for proposed legislation, and shall report any findings or recommendations, including the commissioner's report under subparagraph (a), to the speaker of the house, the president of the senate, the governor, and the chairperson of the joint legislative committee on administrative rules by January 1 of each year.

II. The remainder of this act shall take effect 60 days after its passage.

(Approved: Enacted in accordance with Article 44, Pt. II of N.H. Constitution, without signature of Governor, May 23, 2002)