HB332 (2011) Detail

Relative to an electronic controlled drug prescription monitoring program.


HB 332-FN – AS INTRODUCED

2011 SESSION

11-0016

01/09

HOUSE BILL 332-FN

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

SPONSORS: Rep. Rosenwald, Hills 22; Rep. Harding, Graf 11; Rep. MacKay, Merr 11; Rep. Gargasz, Hills 5; Rep. Millham, Belk 5; Rep. Suzanne Smith, Graf 7; Rep. Butynski, Ches 4; Sen. Larsen, Dist 15

COMMITTEE: Executive Departments and Administration

ANALYSIS

This bill establishes the electronic controlled drug prescription monitoring program. The bill grants the New Hampshire pharmacy board 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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

11-0016

01/09

STATE OF NEW HAMPSHIRE

In the Year of Our Lord Two Thousand Eleven

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 prescription drug abuse is a significant problem in New Hampshire, and that individuals with substance abuse disorder seek controlled drugs from health care providers. The general court believes that allowing providers to have access to information suggesting that their patients have been “doctor shopping” can help them provide better care for these patients. The general court also recognizes that there may be practitioners who are fraudulently prescribing controlled substances, leading to an increase in the impact of prescription drug abuse in New Hampshire. Numerous states have addressed the issue of controlled substance abuse 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.

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. “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.

III. “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 board shall design, establish, and contract with a third party for the operation of 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 board 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) Number of refills granted.

(6) National Drug Code (NDC) of drug dispensed.

(7) Quantity dispensed.

(8) Number of days supply of drug.

(9) Patient’s name.

(10) Patient’s address.

(11) Patient’s date of birth.

(12) Patient’s telephone number.

(13) 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 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 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 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. Any practitioner who prescribes for a patient receiving treatment in an emergency department of a hospital, or who specializes in pain management or oncology shall be encouraged to submit a request to the program for the medication history of a patient prior to prescribing a schedule II-III controlled drug for that patient. This paragraph shall only apply when the program shall be maintained in a web-based electronic form.

VIII. The board 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 access to data maintained by the program. The system of registration shall be established by rules adopted by the board, pursuant to RSA 541-A.

IX. All costs incurred by the board for implementing and operating the program shall be supported through grants or gifts. The board may charge a fee to individuals who request data relating to their own prescription history. A fee charged for an individual’s request for his or her personal data shall not exceed the actual cost of providing that information.

X. Prescription information collected relating to any individual that does not meet the level established to suggest possible drug abuse or diversion shall be deleted within 100 days after the initial prescription was dispensed. All other information shall be deleted after 3 years.

318-B:33 Access to Prescription Information.

I. 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 section.

II. The board 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 board of registration in optometry, the board of podiatry, the board of medicine, the board of dentistry and the board of nursing; provided, however, that the disclosures to each board relate only to its licensees and only with respect to patients whose prescription drug activities indicate possible drug abuse.

(3) Authorized law enforcement officials on a case-by-case basis for the purpose of investigation and prosecution of a criminal offense when presented with a court order based on probable cause. No law enforcement agency or official shall have direct access to the program.

(4) 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 program shall notify the appropriate health care regulatory board listed in subparagraph II(b)(2) and the treating health care provider at such regular intervals as may be established by the board if there is reasonable cause to believe a violation of law or breach of professional standards may have occurred. The program shall provide prescription information required or necessary for an investigation.

318-B:34 Rulemaking. By June 30, 2012, the board shall adopt rules, pursuant to RSA 541-A, necessary to implement the program including:

(a) The criteria for reviewing the prescribing and dispensing information collected.

(b) The criteria for reporting matters to the applicable health care regulatory board for further investigation.

(c) The criteria for notifying health care providers of individuals that are engaged in obtaining controlled substances from multiple prescribers or dispensers.

(d) A schedule of fines under RSA 318-B:32, III.

(e) Content and format of all forms required under this subdivision.

318-B:35 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:36 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.

3 Applicability; Reports 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 pharmacy board 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, 2015 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, including but not limited to changes in the number and type of drug-related deaths, the number of instances of drug abuse, and the number of instances of overprescribing.

III. The pharmacy board shall report annually to the oversight committee of health and human services relative to the effectiveness of the program established in section 2 of this act. The report shall include, but not be limited to, changes in the number and type of drug-related deaths, the number of instances of drug abuse, and the number of instances of overprescribing.

4 New Paragraphs; Notation Required. Amend RSA 318-B:9 by inserting after paragraph VI the following new paragraphs:

VII. Each written prescription prescribed by a practitioner in this state for a controlled drug listed in schedule II or III, as defined in RSA 318-B:31, 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.

VIII. 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 paragraph III or records it electronically, if permitted by federal law. Such prescriptions shall contain the date of the oral or electronic authorization.

5 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 6 of this act.

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

7 Effective Date.

I. Section 6 of this act shall take effect July 1, 2016.

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

LBAO

11-0016

Revised 02/09/11

HB 332 FISCAL NOTE

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

FISCAL IMPACT:

      The Judicial Branch, Judicial Council, the Departments of Corrections and Justice, and the New Hampshire Pharmacy Board state this bill may increase state revenue and expenditures by an indeterminable amount in FY 2011 and in each year thereafter. There will be no impact on county or local revenue and expenditures.

METHODOLOGY:

    The Judicial Branch states this bill will establish a controlled drug prescription monitoring program. The Branch indicates several sections could have a fiscal impact on the Branch. Proposed RSA 318-B:36 makes it a class B felony for an unauthorized person to access, alter, destroy, or disclose program information. Second proposed RSA 318-B:32, III, IV, V, VI provide for administrative violation offenses before the pharmacy board with administrative fines. Decisions of the Pharmacy Board can be appealed to the Supreme Court. Finally, proposed RSA 318-B: 32,V provides for “appropriate criminal charges” for failure to report done knowingly to conceal criminal activity. The branch has no information on which to estimate how many new felonies, new administrative appeals, or other criminal charges will be brought under this bill. The Branch does have information on the average costs for processing a felony in the trial courts. The cost to the Judicial Branch of an average routine criminal case in the superior court is estimated to be $394.13 in FY 2012 and $399.33 in FY 2013. In addition there would be costs associated with potential appeals. The Branch has no information on how many administrative appeals may arise from the pharmacy board administrative violation proceedings and states the Supreme Court has discretionary review of the appeals, however one such appeal could result in a fiscal impact in excess of $10,000. The Judicial Branch has no information on how many new criminal charges will be brought for failure to report done knowingly to conceal criminal activity or at what level those charges would be. The Branch assumes the charges would be a class A misdemeanor or a felony, which would be classified as a routine criminal as described above. The cost to the Branch of an average class A misdemeanor charge in the district court is estimated to be $60.03 in FY 2012 and $60.88 in FY 2013. Additional costs would be incurred for appeals. These amounts are not known.

    The Judicial Council states this bill may result in an indeterminable increase in general fund expenditures. The Council states that if an individual is found to be indigent, the flat fee of $756.25 per felony is charged by a public defender or contract attorney. If an assigned counsel attorney is used the fee is $60 per hour with a cap of $4,100 for a felony charge. Additional costs could be incurred if “Services Other than Counsel” are requested by the defense and approved by the court. The Council is not able to accurately predict the number of cases that may result from this bill.

    The Department of Corrections is not able to determine how many individuals would be subject to incarceration in the State’s prisons as a result of this bill. The Department states the average annual cost of incarcerating an individual in FY 2010 was $32,492 and the costs to supervise and offender by the Division of Field Services was $659.

    The Board of Pharmacy states this bill will increase state expenditures and revenue by an indeterminable amount in FY 2011 and in each year thereafter. The Department assumes the costs incurred to write rules, prepare the RFP and operated the program will not exceed $10,000 per year. The Board is not able to estimate the amount of grants and gifts that will be received to operate the program.

      The Department of Justice states this bill may increase the number of appeals handled by the Criminal Justice Bureau, but the increase would be marginal and could be handled within the Department’s current resources. The Department assumes the Civil Bureau would assist the Pharmacy Board with implementation of the program. The Department indicated this work would also be performed with existing resources.

    The Office of the Legislative Budget Assistant, Audit Division states the cost of the performance audit can be absorbed without additional funding, but performance of the audit will decrease the time available to conduct other performance audits.