HB 1714-FN – AS AMENDED BY THE HOUSE
07Mar2006… 1129h
07Mar2006… 1267h
2006 SESSION
01/09
HOUSE BILL 1714-FN
AN ACT relative to an electronic controlled drug prescription monitoring program.
SPONSORS: Rep. Pilliod, Belk 5; Rep. MacKay, Merr 11; Rep. Emerson, Ches 7
COMMITTEE: Health, Human Services and Elderly Affairs
This bill establishes the electronic controlled drug prescription monitoring program. The bill grants the commissioner 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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
07Mar2006… 1129h
07Mar2006… 1267h
06-2493
01/09
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Six
AN ACT relative to an electronic controlled drug prescription monitoring program.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Findings.
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 150 percent increase in deaths in the last 8 years from these drugs, primarily Methadone. 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 Controlled Drug Prescription Monitoring Program Act.
II. This act is intended to reduce the mortality, morbidity, and criminal activity associated with prescription drug diversion. This act is intended to reduce New Hampshire’s associated health and criminal justice costs, while supporting the availability of controlled substances needed for appropriate medical care. Finally, by allowing controlled practitioner access, this act is also designed to create a greater sense of comfort, safety, and security in the provider-patient relationship when these substances are appropriately prescribed.
2 New Subdivision; Controlled Drug Prescription Monitoring Program Act. Amend RSA 318-B by inserting after section 30 the following new subdivision:
Controlled Drug Prescription Monitoring Program Act
318-B:31 Definitions. In this subdivision:
I. “Committee” means the controlled prescription drug advisory committee established in RSA 318-B:33.
II. “Department” means the department of health and human services.
III. “Dispenser” means a person who delivers a schedule II–IV controlled prescription drug or its analog to the ultimate user but does not include:
(a) A licensed hospital pharmacy that distributes such drugs for the purpose of inpatient hospital care.
(b) A practitioner, or other authorized person who administers such a drug.
(c) A wholesale distributor of a schedule II-IV controlled prescription drug or its analog.
318-B:32 Controlled Drug Prescription Monitoring Program; Penalties.
I. The department shall design and establish an electronic system consistent with the American Society for Automation in Pharmacy (ASAP) standards to monitor the prescribing and dispensing of controlled prescription drugs listed in schedules II, III, and IV, and other additional prescription drugs demonstrating a potential for abuse, by practitioners within the state, and the dispensing of such controlled prescription drugs to an individual at a specific address within the state by a pharmacy permitted by or registered with the pharmacy board.
II.(a) Each dispenser shall submit to the department, within 15 days of the last day of each month by electronic means, 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 DEA registration number.
(2) Prescriber’s DEA registration number.
(3) Date of dispensing.
(4) Prescription number.
(5) Prescription is new or a refill.
(6) Number of refills granted.
(7) NDC Code of drug dispensed.
(8) Quantity dispensed.
(9) Number of days supply of drug.
(10) Patient’s name.
(11) Patient’s address.
(12) Patient’s date of birth.
(13) Patient’s telephone number.
(14) Date prescription was written by prescriber.
(b) This section does 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 fails to submit this information within the time period designated in paragraph II or knowingly submits incorrect information shall be guilty of a violation for which a civil fine shall be imposed. The fine schedule shall be established by rule, pursuant to RSA 541-A, and shall not exceed a maximum of $500 per violation.
IV. Any person who knowingly fails to report the dispensing of a controlled prescription drug listed in schedules II-IV, as required by this section, shall be guilty of a violation and subject to the penalties established under RSA 318-B:26 and Ph 710 of the pharmacy board’s administrative rules.
V. Any person who knowingly engages in prescribing or dispensing of controlled prescription drugs without having registered with the pharmacy board shall be guilty of a violation for which a civil penalty may be imposed. The civil penalties shall be established by rule adopted by the pharmacy board pursuant to RSA 541-A.
VI. The department shall develop a system of registration for all prescribers and dispensers of controlled substances within the state. The contents of the application and any fee for registration shall be established by the commissioner by rule, pursuant to RSA 541-A.
VII. All costs incurred by the department for implementing the prescription monitoring 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 aforementioned grants, gifts, or fees charged under this paragraph. The department may charge a fee to an individual who requests their 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.
VIII. 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.
318-B:33 Advisory Committee Established.
I. There is hereby established an advisory committee to assist the commissioner in carrying out his or her duties under this subdivision. The members of the committee 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 New Hampshire nursing board, appointed by the board.
(e) The attorney general, or designee.
(f) The commissioner of the department of health and human services, or designee.
(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.
II. In addition to the duties under RSA 318-B:34, the purpose of the committee shall be to:
(a) Adopt and revise the criteria for reviewing the prescribing and dispensing 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.
(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 committee shall meet on a quarterly basis and other times as determined by the committee to discharge its responsibilities and to evaluate data.
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 paragraphs III and IV. 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, is not a public record, and is 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 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 paragraphs III and IV.
III. The committee may review only the prescription information as outlined in RSA 318-B:33, III 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.
IV.(a) The committee may provide data from the prescription monitoring program to the following persons and entities:
(1) Persons authorized to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care for their patients.
(2) An individual who requests his or her own prescription monitoring information.
(3) The state boards listed in RSA 318-B:33, the board of registration in optometry, and the board of podiatry.
(4) 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 licit drugs.
(5) The department of health and human services.
(6) A court in a criminal matter or a grand jury which requests such information.
(b) The committee may provide data to 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.
318-B:35 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 controlled drug prescription monitoring program.
318-B:36 Rulemaking. The commissioner shall adopt rules pursuant to RSA 541-A, relative to:
I. A schedule of fines under RSA 318-B:32, III.
II. Content and format of all forms required under this subdivision.
III. Procedures, meetings, and conduct of the advisory committee established in RSA 318-B:33.
318-B:37 Limitation of Liability. Any agency or individual who provides or receives information in good faith from the 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:38 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. In the event that there is not adequate funding for the Controlled Drug Prescription Monitoring Program established in section 1 of this act, the commissioner of the department of health and human services may curtail, temporarily suspend, or cancel the program.
4 New Paragraph; Notation Required. Amend RSA 318-B:9 by inserting after paragraph VI the following new paragraph:
VII. Each written prescription prescribed by a practitioner in this state for a controlled substance listed in schedule II, III, IV, or V, shall include both a written and 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 Section; Positive Identification Required. Amend RSA 318-B by inserting after section 9 the following new section:
318-B:9-a Positive Identification Required.
I.(a) A pharmacist shall not dispense a controlled substance listed in schedule II, III, or IV to a patient or a patient’s agent without first determining, in the exercise of his or her professional judgment, that the order is valid. A pharmacist or pharmacist’s agent shall request the patient’s or patient’s agent’s identification information prior to dispensing any controlled substance. Appropriate identification shall be in the form of:
(1) A valid driver’s license of the patient or patient’s agent, issued under New Hampshire law or the law of any other state;
(2) A valid military identification issued to either the patient or the patient’s agent; or
(3) Any other government issued photo identification document.
(b) If the patient or patient’s agent does not have the appropriate 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, or IV shall 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, or IV may be dispensed by a pharmacist upon an oral or electronic prescription if, before filling the prescription, the pharmacist reduces it to writing, pursuant to the requirements of RSA 318-B:9, III, IV, and V or records it electronically, if permitted by federal law. Such prescriptions shall contain the date of the oral or electronic authorization.
6 Effective Date. This act shall take effect January 1, 2007.
LBAO
06-2493
Revised 1/10/06
HB 1714 FISCAL NOTE
AN ACT relative to an electronic controlled drug prescription monitoring program.
FISCAL IMPACT:
The Department of Health and Human Services states this bill will increase state restricted revenue and expenditures by $50,000 in FY 2007, $350,000 in FY 2008, and $200,000 in FY 2009 and each year thereafter. There will be no fiscal impact on county and local revenue or expenditures.
METHODOLOGY:
The Department of Health and Human Services (DHHS) states this bill would direct the Department to establish an electronic controlled substance prescription drug-monitoring program to be effective by January 1, 2007. The program shall be self-funded through grants, gifts, and fees. The Department states that according to information received by the New Hampshire Department of Justice from the United States Department of Justice, overall costs for developing and operating a controlled substance prescription drug-monitoring program are approximately $50,000 in the planning phase, up to $350,000 for program design, and approximately $200,000 annually thereafter. The Department states this bill will require a part-time Health Promotion Advisor (0.5 FTE) at Labor Grade 23, and estimates the breakdown of costs as follows:
FY 2007 FY 2008 FY 2009 FY 2010
Salary & Benefits $25,848 $ 53,998 $ 56,441 $ 59,240
Current Expenses 1,500 1,500 1,500 1,500
Equipment 3,500 0 0 0
In-State Travel 2,000 1,000 1,000 1,000
Out-of-State Travel 4,000 2,000 2,000 2,000
Program Operations 13,152 291,502 139,059 136,260
Total $50,000 $350,000 $200,000 $200,000
The Pharmacy Board states they are unable to determine a fiscal impact at this time.