HB 1636-FN – AS INTRODUCED
2010 SESSION
01/10
HOUSE BILL 1636-FN
AN ACT establishing the real-time electronic controlled drug prescription monitoring program.
SPONSORS: Rep. Rice, Merr 12; Rep. Tilton, Merr 6; Rep. Skinder, Sull 1
COMMITTEE: Health, Human Services and Elderly Affairs
This bill establishes the real-time electronic controlled drug prescription monitoring program. The bill grants the commissioner of the department of health and human services rulemaking authority for the purposes of the bill.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
10-2332
01/10
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Ten
AN ACT establishing the real-time electronic controlled drug prescription monitoring program.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Statement of Intent.
I. The general court recognizes that nationally there has been a significant increase in the number of deaths from the abuse of controlled substance prescription drugs, primarily opioids such as Oxycontin and Methadone. New Hampshire has seen a 200 percent increase in deaths in the last 10 years from these drugs, primarily Methadone, with prescription drug abuse being the fastest growing form of substance abuse. Numerous states have addressed the issue of controlled substance abuse and diversion into the illegal drug trade by adopting electronic programs to monitor the prescribing and dispensing of controlled substances. Therefore, the general court hereby establishes the real time electronic controlled drug prescription monitoring program.
II. This act is intended to reduce patient mortality and morbidity associated with prescription drug use by providing a secure program by which the provider and the dispenser can access information on the patient’s prescription history. The program established by this act is designed to create greater safety, security, and comfort in the provider-patient relationship when medications are prescribed. Finally, by allowing restricted access by authorized law enforcement, under well-defined circumstances, this act may help reduce criminal justice costs associated with prescription drug diversion.
2 New Subdivision; Real-Time Electronic Controlled Drug Prescription Monitoring Program. Amend RSA 318-B by inserting after section 30 the following new subdivision:
Real-Time Electronic Controlled Drug Prescription Monitoring Program
318-B:31 Definitions. In this subdivision:
I. “Committee” means the controlled prescription drug review committee established in RSA 318-B:35.
II. “Council” means the controlled prescription drug advisory council established in RSA 318-B:33.
III. “Dispenser” means a person who delivers a schedule II, III, IV, V controlled prescription drug or its analog to the ultimate user but does not include a wholesale distributor of a schedule II, III, IV, V controlled prescription drug or its analog.
IV. “Program” means the real time electronic controlled drug prescription monitoring program established in RSA 318-B:32.
V. “System” means captures data in real time, as a byproduct of electronic prescribing and includes:
(a) Providing drug history information, interaction information, and formulary information to prescribers as they prescribe, automatically;
(b) Capturing and delivering prescriptions to pharmacies electronically and tracks the actual “fill,” ensuring compliance through the entire administration of a given prescription drug.
318-B:32 Real-Time Electronic Controlled Drug Prescription Monitoring Program; Penalties.
I. The department shall establish a real-time electronic prescription drug system for monitoring schedules II, III, IV, and V controlled substances that are dispensed within the state by a practitioner or pharmacist or dispensed to an address within the state by a pharmacy licensed by the pharmacy board.
II.(a) Each dispenser shall use the real-time electronic prescription drug system to submit information regarding each dispensing of a controlled prescription drug. The information submitted for each dispensing shall include, but not be limited to:
(1) Dispenser’s Drug Enforcement Administration (DEA) registration number.
(2) Prescriber’s DEA registration number.
(3) Date of dispensing.
(4) Prescription number.
(5) Whether prescription is new or a refill.
(6) Number of refills granted.
(7) National Drug Code (NDC) of drug dispensed.
(8) Quantity dispensed.
(9) Number of days supply of drug.
(10) Patient’s name.
(11) Patient’s address.
(12) Date prescription was written by prescriber.
(b) This section shall not apply to controlled drugs:
(1) Administered by a health care practitioner directly to a patient.
(2) Dispensed by a health care practitioner authorized to dispense pursuant to RSA 318:42 and RSA 318-B:10.
(3) Either dispensed by a pharmacist or administered by a health care practitioner to an in-patient or resident receiving care from a hospital, nursing home, assisted living facility, home health care agency, hospice, or intermediate care facility for the developmentally disabled or mentally ill which is licensed in this state.
III. Any person who knowingly submits incorrect information shall be subject to a class B felony. Any person who subsequently resubmits incorrect information shall be considered to have done so knowingly and shall be guilty of a class B felony.
IV. Any person who fails to report the dispensing of a controlled drug listed in schedule II, III, IV, V, as required by this section, shall be guilty of a class A misdemeanor, except when such failure to report conceals a pattern of diversion of controlled substances into illegal use, then such person shall be considered to have done so knowingly and shall be guilty of a class B felony and subject to the penalties established under RSA 318-B:26 and Ph 710 of the pharmacy board’s administrative rules.
V. Any person whose failure to report conceals a pattern of diversion of controlled substances into illegal use shall be guilty of a class B felony and subject to the penalties established under RSA 318-B:26 and Ph 710 of the pharmacy board’s administrative rules. In addition, such person may be subject to class B felony criminal charges if the failure to report is determined to have been done knowingly to conceal criminal activity.
VI. Any person or organization who engages in dispensing of controlled prescription drugs without having registered with the pharmacy board shall be guilty of a class B felony, and shall have a civil penalty imposed. The civil penalties shall be established by rule adopted by the pharmacy board pursuant to RSA 541-A.
VII. Any person or organization which has not registered with the pharmacy board and who engages in dispensing of controlled prescription drugs that results in a death shall be guilty of a class A felony.
VIII. The department shall establish a system of registration for all prescribers and dispensers of controlled substances within the state. No person shall procure, dispense, administer, or prescribe a controlled drug without having first obtained a registration to do so from the department. An application together with any fee that may be required by the department shall be filed annually on or before October 1. All prescribers of opioids shall attend educational courses regarding the safe use and prescription of opioids. The system of registration, contents of the application, and educational courses shall be established by the commissioner by rule, pursuant to RSA 541-A.
IX. All costs incurred by the department for implementing the real time electronic prescription drug system shall be supported through grants or gifts, or both, dedicated specifically for such system. Thereafter, the program shall be self-funding by either the grants or gifts, or fees charged under this paragraph. The department may charge a fee to an individual who requests his or her own program information or to a person who requests statistical, aggregate, or non-personally identified information from the program. The department may charge a fee to an individual who requests information for public research, policy, or education purposes as long as all information revealing the identity of the patient, the prescriber, the dispensing pharmacist, or the dispensing pharmacy has been removed. A fee charged for an individual’s request shall not exceed the actual cost of providing the requested information.
318-B:33 Advisory Council Established.
I. There is hereby established an advisory council to assist the commissioner in carrying out his or her duties under this subdivision. The members of the council shall be as follows:
(a) A representative of the New Hampshire board of medicine, appointed by the board.
(b) A representative of the pharmacy board, appointed by the board.
(c) A representative of the board of dental examiners, appointed by the board.
(d) A representative of the board of nursing, appointed by the board.
(e) The attorney general, or designee.
(f) A representative of the department of health and human services, appointed by the commissioner.
(g) A representative of the New Hampshire Medical Society, appointed by the society.
(h) A representative of the New Hampshire Dental Society, appointed by the society.
(i) A representative of the New Hampshire Association of Chiefs of Police, appointed by the association.
(j) A representative of a retail pharmacy, appointed jointly by the New Hampshire Pharmacists Association, the New Hampshire Independent Pharmacy Association, and the New Hampshire Association of Chain Drug Stores.
(k) A representative of a New Hampshire based drug prevention organization, appointed by the governor.
II. The purpose of the council shall be to:
(a) Adopt and revise the criteria for reviewing the prescribing and dispensing of information collected.
(b) Adopt and revise the criteria for reporting matters to the applicable health care regulatory board for further investigation.
(c) Adopt and revise the criteria for reporting matters to and working cooperatively with, the appropriate law enforcement agency for further investigation.
(d) Adopt and revise the criteria for notifying health care providers of individuals that are engaged in obtaining controlled substances from multiple prescribers or pharmacies.
(e) Collect information on the outcomes and impact of the prescription monitoring program including: user satisfaction, impact on prescribing patterns, impact on referrals to regulatory boards and law enforcement entities, and other relevant measures.
III. The council shall meet on a quarterly basis and other times as determined by the council to discharge its responsibilities and to evaluate data. The first meeting shall be called by the representative of the department of health and human services within 45 days of the effective date of this subdivision. At the first meeting, a chairman shall be elected by the members.
318-B:34 Access to Prescription Information.
I. Prescription information submitted to the department shall be confidential and not be subject to RSA 91-A, except as provided under RSA 318-B:35, II and III. Information contained in the program and any information obtained from it, and information contained in the records of requests for information from the program, is privileged and strictly confidential, not a public record, and not subject to discovery, subpoena, or other means of legal compulsion for release except as provided in this section. Information from the program shall not be released, shared with an agency or institution, or made public except as provided in this chapter. Information collected for the program shall be retained by the program for 4 years. The information shall then be destroyed.
II. The department shall establish and maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted; and maintained, is not disclosed to persons except as provided in RSA 318-B:35, III.
318-B:35 Controlled Prescription Drug Review Committee.
I. There is established a controlled prescription drug review committee. The members of the committee shall be as follows:
(a) One member of the house of representatives, appointed by the speaker of the house of representatives.
(b) One member of the senate, appointed by the president of the senate.
(c) The commissioner of the department of health and human services, or designee.
II. The committee may review only the prescription information as outlined in RSA 318-B:33, II after removing information that could be used to identify prescribers, individual patients, and persons who received prescriptions from a dispenser. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the committee shall notify the appropriate law enforcement or professional licensing, certification, or regulatory agency or entity and provide prescription information required or necessary for an investigation.
III. The committee may provide data from the program to the following persons and entities:
(a) Persons authorized to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care for their patients.
(b) An individual who requests his or her own prescription information.
(c) The state boards listed in RSA 318-B:33, the board of registration in optometry, and the board of podiatry.
(d) Local, state, and federal law enforcement or prosecutorial officials and others as established by rule, pursuant to RSA 541-A, engaged in the investigation or enforcement of the laws governing illicit drugs.
(e) The department of health and human services.
(f) A court in a criminal matter or a grand jury which requests such information.
(g) Public or private entities for statistical, research, or educational purposes after removing information that could be used to identify prescribers, individual patients, and persons who received prescriptions from a dispenser.
IV. The committee may meet as often as necessary to effectuate its goals.
318-B:36 Authority to Contract. The department may contract with another agency of this state or with a private vendor, as necessary, to ensure the effective operation of the program.
318-B:37 Rulemaking. The commissioner shall adopt rules, pursuant to RSA 541-A, relative to:
I. A schedule of fines under RSA 318-B:32, VI.
II. Content and format of all forms required under this subdivision.
III. Procedures, meetings, and conduct of the advisory council established in RSA 318-B:33.
318-B:38 Limitation of Liability. Any agency or individual who provides or receives information in good faith from the real-time electronic controlled drug prescription monitoring program shall not be liable for civil damages, be prosecuted criminally, or be subjected to disciplinary action by an employer.
318-B:39 Unauthorized Access, Alteration, Destruction, or Disclosure of Information. A person is guilty of a class B felony if the person knowingly discloses or attempts to disclose, or uses or attempts to use, prescription monitoring information except as authorized in this subdivision or as otherwise authorized by law.
3 Applicability; Report Required.
I. If there is not adequate funding for the real-time controlled drug prescription monitoring program established in section 2 of this act, the commissioner of the department of health and human services may curtail, temporarily suspend, or cancel the program.
II. The commissioner of the department of health and human services shall make a report to the speaker of the house of representatives, the president of the senate, and the governor on or before November 1, 2013 evaluating the effectiveness of the program established in section 2 of this act.
4 New Paragraph; Notation Required. Amend RSA 318-B:9 by inserting after paragraph VI the following new paragraph:
VII. Each computer generated prescription prescribed by a practitioner in this state for a controlled substance listed in schedules II, III, IV, and V, shall include a numerical notation of the quantity on the face of the prescription and a notation of the date with the abbreviated month written on the face of the prescription. A pharmacist shall be permitted, upon verification by the prescriber, to document any information required by this paragraph.
5 New Sections; Positive Identification Required. Amend RSA 318-B by inserting after section 9 the following new sections:
318-B:9-a Positive Identification Required.
I.(a) A pharmacist shall not dispense a controlled substance listed in schedule II, III, IV, V to a patient or a patient’s agent without first determining, in the exercise of his or her professional judgment, that the prescription or prescriptions are valid. A pharmacist or pharmacist’s agent shall request the patient’s or patient’s agent’s biometric and personal identification prior to dispensing any controlled substance.
(1) Appropriate biometric scan identification shall be in the form of:
(A) Finger and or thumb print;
(B) 3-D facial;
(C) Retinal; or
(D) Vascular.
(2) Appropriate personal identification shall be in the form of:
(A) A valid driver’s license of the patient or patient’s agent, issued under New Hampshire law or the law of any other state;
(B) A valid military identification issued to either the patient or the patient’s agent; or
(C) Any other government issued photo identification document.
(b) If the patient or patient’s agent does not have the appropriate personal identification, the pharmacist may dispense the controlled substance only when the pharmacist determines, in the exercise of his or her professional judgment, that the order is valid and includes such information in the patient’s record. The commissioner may adopt by rule under RSA 541-A the required patient information for controlled drug dispensing and procedures for a pharmacist to verify the validity of a prescription for a controlled substance in which the pharmacist was not provided the required information.
II. Any pharmacist that dispenses by mail, a controlled prescription drug, listed in schedule II, III, IV, or V shall not be exempt from the requirement to obtain suitable identification for that prescription dispensed by mail.
III. Any controlled prescription drug listed in schedule II, III, IV, or V may be dispensed by a pharmacist upon an electronic prescription if, before filling the prescription, the pharmacist reduces it to writing, pursuant to the requirements of RSA 318-B:9, III or records it electronically, if permitted by federal law. Such prescriptions shall contain the date of the electronic authorization.
318-B:9-b Security and Process.
I. The system shall:
(a) Have the capability of using levels of up to 4096 bit encryption.
(b) Use multi-factor authentication, multiple keys between users and computer servers themselves to insure that only trusted access is provided.
(c) Use a variety of biometric interfaces that are available which include, finger print, 3-D facial, retinal and vascular devices.
(d) Operate on a closed network which creates a network of trusted and authenticated users providing point-to-point connectivity.
II. The security process shall begin from when the prescription is computer generated and then create a mechanism for tracking the prescription through the entire process until it is dispensed. Identification of the patient shall begin with his or her biometric authentication at the physician’s office and shall conclude with his or her acknowledgement of receipt by biometric authentication at the pharmacy
6 Effective Date. This act shall take effect January 1, 2011.
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12/16/09
HB 1636-FN - FISCAL NOTE
AN ACT establishing the real-time electronic controlled drug prescription monitoring program.
FISCAL IMPACT:
The Department of Health and Human Services states this bill will increase state expenditures by $2,287,519 in FY 2011, and by $3,575,038 in FY 2012 and each year thereafter, and increase state restricted revenue by an indeterminable amount in FY 2012 and each year thereafter. This bill will have no fiscal impact on county and local revenue or expenditures.
METHODOLOGY:
The Department of Health and Human Services (DHHS) states this bill establishes the real-time electronic controlled drug prescription monitoring program. The Department states the program would include an electronic system connecting approximately 10,000 prescribers to 400 dispensers. A contract will be procured to develop and operate a program from an outside vendor, and the program would exclude prescriptions dispensed directly from a facility to a patient (i.e. - hospitals, nursing homes, etc.). Program users would include prescribers, dispensers and law enforcement, and dispensers would include pharmacies and mail order but excludes wholesale distributors. Program data would be available to other authorized groups including patients and researchers. The Department states a dedicated network is required to ensure compliance with federal and state privacy and security requirements, including Health Insurance Portability and Accountability Act (HIPAA) requirements, and United States Department of Justice, Drug Enforcement Administration (DEA) requirements on transmission of electronic data for pharmaceutical controlled substances. The registration system for all prescribers and dispensers of controlled drugs would be the responsibility of DHHS, and would require education for prescribers and validation requirement with the DEA. Dispensers for patients will require positive identification through the use of personal identification and biometrics (fingerprint, retinal or vascular). The Department assumes the cost of biometric machines would be funded by the dispensers. The cost of a finger print machine is approximately $25,000 per unit. Biometric systems would require staff training, verification with an existing system such as the national fingerprint and criminal history system maintained by the Federal Bureau of Investigation (FBI). Although this bill does not establish positions or contain an appropriation, the Department assumes they would hire a senior
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management analyst (LG 26) with salary and benefit costs of approximately $75,038 annually. The Department states the cost to develop the program would be approximately $500,000 based on a US Department of Justice nationwide study of existing prescription drug monitoring program. The Department estimates the vendor costs based on a similar DHHS contract and scope of the proposed program would total $3,500,000 annually. The Department anticipates there may be additional costs for other state agencies such as the Department of Justice, Department of Safety and the Board of Pharmacy to implement and operate the program which are indeterminable at this time since roles and responsibilities have not yet been established. Assuming an effective date of January 1, 2011, the Department estimates the fiscal impact as follows –
FY 2012
FY 2011 & Thereafter
Development of Program $500,000 $0
DHHS Staff $37,519 $75,038
Operations – Vendor Costs $1,750,000 $3,500,000
Total $2,287,519 $3,575,038
The Department states this bill would require the program to be self- funded. At this time, DHHS does not know what, if any, grants or gifts would be awarded to fund the Program. The Department assumes that any revenue generated by fees, grants or gifts would not be available to offset the development and start up costs anticipated in SFY 2011.