HB630 (2008) Detail

Relative to an electronic controlled drug prescription monitoring program.


HB 630-FN – AS AMENDED BY THE HOUSE

23Jan2008… 2662h

2007 SESSION

07-0640

01/09

HOUSE BILL 630-FN

AN ACT relative to an electronic controlled drug prescription monitoring program.

SPONSORS: Rep. MacKay, Merr 11; Rep. Rosenwald, Hills 22; Rep. Schulze, Hills 26; Rep. Hess, Merr 9; Rep. Batula, Hills 19; Sen. Hassan, Dist 23

COMMITTEE: Health, Human Services and Elderly Affairs

ANALYSIS

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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

23Jan2008… 2662h

07-0640

01/09

STATE OF NEW HAMPSHIRE

In the Year of Our Lord Two Thousand Seven

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 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 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, and prescription drug abuse is 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 drugs. Therefore, the general court hereby establishes the controlled drug prescription monitoring program.

II. This program is intended to reduce patient mortality and morbidity associated with controlled drugs by providing a secure program through which the prescriber and the dispenser may access information on the patient’s controlled drug prescription history. The program established by this act is designed to create a greater sense of safety, security, and comfort in the provider-patient relationship when controlled drugs 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; Controlled Drug Prescription Monitoring Program. Amend RSA 318-B by inserting after section 30 the following new subdivision:

Controlled Drug Prescription Monitoring Program

318-B:31 Definitions. In this subdivision:

I. “Board” means the pharmacy board, established in RSA 318:2.

II. “Commissioner” means the commissioner of the department of health and human services.

III. “Council” means the advisory council established in RSA 318-B:33.

IV. “Department” means the department of health and human services.

V. “Dispenser” means a person who delivers a schedule II–III controlled drug or its analog to the ultimate user but does not include:

(a) A licensed hospital pharmacy when distributing 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-III controlled drug or its analog.

VI. “Program” means the controlled drug prescription monitoring program established in RSA 318-B:32.

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 drugs listed in schedules II and III, by practitioners within the state, and the dispensing of such controlled drugs by a pharmacy within the state or located within another state when dispensed 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 information regarding each dispensing of a controlled drug in schedules II or III. 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) Patient’s date of birth.

(13) Patient’s telephone number.

(14) Date prescription was written by prescriber.

(15) Type of payment for prescription, cash or other.

(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 fails to submit the information required in paragraph II or submits incorrect information shall be subject to a warning letter and provided with an opportunity to correct the failure. Any person who subsequently fails to correct or fails to resubmit the information shall be considered to have done so knowingly and 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 fails to report the dispensing of a controlled drug listed in schedules II and III, as required by this section, shall be subject to a warning letter and provided with an opportunity to correct the failure, unless the failure to report conceals a pattern of diversion of controlled drugs into illegal use. Any person who fails to correct or fails to report again after receiving a warning letter shall be considered to have done so knowingly and 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 whose failure to report conceals a pattern of diversion of controlled drugs into illegal use 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 as applicable. In addition, such person may be subject to appropriate criminal charges if the failure to report is determined to have been done knowingly to conceal criminal activity.

VI. Any person who engages in prescribing or dispensing of controlled drugs in schedule II or III without having registered with the program 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 commissioner pursuant to RSA 541-A.

VII. The department shall develop a system of registration for all prescribers and dispensers of controlled drugs in schedules II or III within the state. Only registered prescribers and dispensers are eligible for electronic access to data maintained by the program. The system of registration shall be established by rules adopted by the commissioner, pursuant to RSA 541-A.

VIII. All costs incurred by the department for implementing and operating the program shall be supported through grants or gifts. The department may charge a fee to individuals who request data relating to their own prescription history or to individuals or entities requesting statistical or aggregate information from the program for public research, policy or educational purposes. A fee charged for an individual’s request for his or her personal data shall not exceed the actual cost of providing that information.

IX. All prescribers of methadone shall attend educational courses regarding the safe use and prescription of methadone. The contents of the educational course shall be established by rules adopted by the commissioner pursuant to RSA 541-A.

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 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) 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.

(k) A representative of the New Hampshire Civil Liberties Union, appointed by such organization.

II. The purpose of the council 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 or dispensers.

(e) Collect information on the outcomes and impact of the program including: satisfaction of users of the program, impact on prescribing patterns, impact on referrals to regulatory boards and law enforcement entities, and other relevant measures.

(f) Assist the commissioner in adopting and revising the rules under RSA 541-A to implement the program.

III. The council may meet as often as necessary to effectuate its goals. 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:34, II, III, and IV. Information contained in the program, information obtained from it, and information contained in the records of requests for information from the program, is confidential, is not a public record or otherwise subject to disclosure under RSA 91-A, and is not subject to discovery, subpoena, or other means of legal compulsion for release and shall not be shared with an agency or institution, except as provided in this subdivision. Information collected for the program shall be retained by the program for 3 years and 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 except as follows:

(a) By electronic or written request, solicited or unsolicited, to prescribers and dispensers within the state who are registered with the program, for the purpose of providing medical or pharmaceutical care to patients; and

(b) By written request, to:

(1) An individual who requests his or her own prescription information.

(2) The state boards listed in RSA 318-B:33, the board of registration in optometry, and the board of podiatry.

(3) Local, state, and federal law enforcement officials investigating alleged criminal activity involving controlled drugs.

(4) The department of health and human services.

(5) A court in a criminal matter or a grand jury which requests such information.

(6) A controlled drug prescription monitoring program from another state, if an agreement is in place with the other state to ensure that the information is used and disseminated pursuant to the requirements of this state.

III. The department may review the prescription information as outlined in paragraph II only after removing information that could be used to identify prescribers and patients. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the department shall notify the appropriate law enforcement agency or professional licensing, certification, or regulatory agency or entity and provide prescription information required or necessary for an investigation.

IV. The department 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 to ensure the effective operation of the program.

318-B:36 Rulemaking. The commissioner, with input and consent from the advisory council, shall adopt rules, pursuant to RSA 541-A, necessary to implement the program including:

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 council established in RSA 318-B:33.

318-B:37 Limitation of Liability. Any agency or individual who provides or receives information in good faith to or from the program shall not be liable for civil damages, prosecuted criminally, or subject 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 accesses, alters, destroys, or discloses program information except as authorized in this subdivision or as otherwise authorized by law.

3 Applicability; Report Required.

I. In the event that there is not adequate funding for the 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 office of the legislative budget assistant shall conduct a performance audit of the program on or before December 31, 2012 for the use of the speaker of the house of representatives, the president of the senate, and the governor in 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 written prescription prescribed by a practitioner in this state for a controlled drug listed in schedule II or III, 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 drug listed in schedule II or III 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 identification from the patient or patient’s agent prior to dispensing any controlled drug. Appropriate identification shall be in the form of:

(1) A valid driver’s license 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 provide 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.

II. Any controlled drug listed in schedule II or III 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 or records it electronically, if permitted by federal law. Such prescriptions shall contain the date of the oral or electronic authorization.

6 Applicability. All prescribing and dispensing information maintained by the program established in section 2 of this act shall be destroyed upon the repeal of the program under section 7 of this act.

7 Repeal. RSA 318-B:31RSA 318-B:39 and sections 1 and 3 of this act, relative to the controlled drug prescription monitoring program, are repealed.

8 Effective Date.

I. Section 7 of this act shall take effect July 1, 2013.

II. The remainder of this act shall take effect upon its passage.

LBAO

07-0640

Revised 03/19/07

HB 630 FISCAL NOTE

AN ACT relative to an electronic controlled drug prescription monitoring program.

FISCAL IMPACT

    The Judicial Branch, Judicial Council, Department of Health and Human Services, Department of Corrections, and Department of Justice state this bill may increase state and county expenditures, and state restricted revenue by an indeterminable amount in FY 2008 and each year thereafter. This bill will have no fiscal impact on county and local revenue, or local expenditures.

METHODOLOGY

    The Judicial Branch states this bill would enact the Controlled Drug Prescription Monitoring Act by adding several sections to RSA 318-B (the Controlled Drug Act). The Branch states the judicial, clerical, jury, and bailiff cost of an average felony case is approximately $297 per charge. This does not consider the cost of any appeals that may be taken following trial. The Branch states the judicial and clerical cost of a class A misdemeanor is approximately $50 per charge. The cost of a routine civil case in the Superior Court is approximately $302. The Branch is unable to determine how many charges or actions may be brought pursuant to this bill, and as a result are unable to determine the exact fiscal impact at this time.

    The Judicial Council assumes that any cases arising from the enactment of this bill for which the Indigent Defense Fund may be liable will, in the first instance, be handled by the public defender or contract attorney who accepts these cases on a fixed fee basis of $756.25 per felony charged. If an assigned counsel attorney must be used, the hourly rate of $60 with a fee cap of $3,000 will apply. If a motion to exceed the fee cap is approved and/or “services other than counsel” are approved, these will also be chargeable to the Indigent Defense Fund. Any charge within the criminal justice system, committed by a juvenile, will be compensated within the flat fee contract system of $275 per case through disposition, plus $206.25 for each and every review hearing following disposition. Assigned counsel will be at the $60 per hour rate with a fee cap of $1,200. The fee cap may be waived upon motion filed with the court and approved in advance. Any case where a defendant has been found guilty may also result in appeals to either the Superior Court or to the Supreme Court which would have a cost implication for Indigent Defense expenditures made by the State. The Council is unable to predict the number of cases which may result from the passage of this bill, and are unable to determine the exact fiscal impact at this time.

    The Department of Health and Human Services states although this bill does not establish any new positions, they assume that a full-time Senior Management Analyst (LG 26) position would be required to ensure that a high quality data program be developed to oversee the coordination among agencies and stakeholders. The Department states a vendor would also be procured to develop, implement, and maintain program software and hardware, and these costs would most likely be supported by the US Department of Justice’s Harold Rogers Program. No additional state general funds are anticipated as a result of this bill. Assuming benefits equal to 48.3% of salary, and annual step increases, the Department estimates the cost as follows:

 

FY2008

FY2009

FY2010

FY2011

Salary and Benefits

$61,973

$64,777

$67,669

$70,707

Current Expenses

$2,000

$2,000

$2,000

$2,000

Equipment

$3,500

$0

$0

$0

Rent

$4,153

$4,463

$4,798

$5,158

Indirect Cost

$26,863

$37,424

$37,797

$38,137

Travel

$7,000

$3,000

$3,500

$3,500

System Contracts

$190,000

$300,000

$300,000

$300,000

Total

$295,489

$411,664

$415,764

$419,502

    The Department of Corrections states the number of individuals who would be found guilty of a felony as a result of this bill cannot be predicted. The Department states for FY 2006, the average annual cost of incarcerating an individual in the general prison population for FY 2006 was $31,140, and the cost to supervise an offender by the Department’s Division of Field Services was $1,174.

    The Department of Justice states the county attorneys would be responsible for prosecuting the new felony offense, and there would be no added responsibility placed on the Department. The Department would be responsible for representing the State on any appeal from a conviction of the new felony, but the Department states these costs could be absorbed by the Department.