COMMENT REQUESTED: Department of Health Proposed VPMS and Opioid Prescribing Rules

Department of Health Proposed VPMS and Opioid Prescribing Rules

The Department of Health released the two proposed rules (attached above) for comment last week:
I. Rule Governing the Prescribing of Opioids for Chronic Pain
II. Vermont Prescription Monitoring System (VPMS) Rule

Please send your comments on these two rules to VMS by Monday, December 15, 2014, if possible. In particular, VMS is seeking comments on the questions and potential concerns listed below each rule.

I. Summary of Rule Governing the Prescribing of Opioids for Chronic Pain (Prescribing Rule)

· Definition of Chronic Pain: Chronic pain is defined as pain "caused by various disease or abnormal conditions" that continues longer than 90 days. The definition, unlike the definition in the Vermont Prescription Monitoring System Rule does not exclude pain caused by cancer. The definition also does not exclude other types of palliative or end of life pain such as ALS.

· Screening and Risk Assessment: The rule requires screening, evaluation and risk assessment when prescribing opioids including documentation of supporting diagnoses, and documentation of benefits and risks including the risk for diversion for the individual patient. The evaluation must include a risk assessment to predict a patient's likelihood for misusing opioids. The rule mentions the Screener and Opioid Assessment for Patients with Pain (SOAPP) as a commonly used risk assessment tool.

· Non- Opioid Alternatives: The rule requires prescribers to consider and document consideration of non-opioid alternatives, trial use of an opioid, and required queries to the VPMS.

· Informed Consent and Treatment Agreements: If opioids are prescribed for 90 days or longer, the prescriber must have a signed Informed Consent and a signed Controlled Substance Treatment Agreement. The rule includes a number of specific requirements for each of these documents. Periodic follow-up visits must be scheduled at least every 180 days. The maximum daily dose or a "not to exceed" equivalent must be written on the prescription.

· Pain and Addiction Consults: The rule requires prescribers to consider consultation with pain specialists when a patient is not meeting treatment goals despite escalating doses or if the patient is at high risk for substance abuse as determined by the risk assessment screening. Prescribers must consider referral for substance abuse evaluation when the patient is high risk as determined by the screening or if the prescriber believes the patient is abusing opioids, seeing multiple prescribers/multiple pharmacies or has been prescribed multiple controlled substances.

· Re-evaluation: Treatment Agreements must be reviewed at least once a year to reevaluate the patient. Based on the reevaluation, the prescriber should document whether to continue treatment with opioids, the need for a pain management or substance abuse consultation.

· Discontinuance of Opioids Required: If the patient has failed to adhere to the Controlled Substance Treatment Agreement, "a plan for the discontinuation of prescribed opioids shall be developed and implemented."

· Prescribing More than 120 Morphine Equivalent Doses (MED): Prior to exceeding a dosage of 120 MED/day from all prescriptions from all prescribers the rule includes a list of six requirements which must be documented including a reevaluation of the effectiveness and safety of the patient's pain management plan and a functional status examination. Link to information from Washington State about MED: http://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/HealthcareProfessionsandFacilities/PainManagement/FrequentlyAskedQuestionsforPractitioners/MorphineEquivalentDosageMed

· Extended Release Hydrocodones and Oxycodones: There are very specific requirements for prescription of extended release hydrocodones and oxycodones without abuse deterrent formulas (ADFs). In addition to requiring evaluation, risk assessment, a signed Informed Consent and a signed Treatment Agreement, these include a requirement to check the VPMS at least every 120 days. Follow-up visits and evaluations are required at least every 180 days.

VMS Potential Concerns and Questions about the Prescribing Rule

· Should the Prescribing Rule exclude palliative care, hospice or other end-of-life care?
· Should the rule expressly exclude the management of acute pain caused by an injury or a surgical procedure.
· The rule requires physicians to check a monitoring system that does not have current and complete information. Data is only uploaded to the VPMS once a week; other states have daily uploads. The data does not include VA data at this time, and no reciprocal information sharing agreements have been developed with neighboring states. The first reciprocal agreement (possibly with Massachusetts) is unlikely to be in place before the fall of 2015.
· The rule requires physicians to use an unwieldy system that has not allowed registration of delegates or registration of resident physicians in training for more than a year.
· Does the rule inappropriately or excessively micromanage patient care and documentation of that care?
· The rule requires a plan for discontinuance of prescribed opioids to be developed and implemented if a patient fails to adhere to a treatment agreement or treatment plan. Should the rule permit exceptions to this requirement?
· The rules requires detailed documentation when all prescriptions from all prescribers exceed 120 MED/day. Without available current and complete data in the VPMS, it will be difficult or impossible for physicians to determine if their patients are receiving a dosage of opioids in excess of 120 MED/day from all prescribers.

II. Summary of the Vermont Prescription Monitoring Rule (VPMS Rule)

The stated purpose of the Vermont Prescription Monitoring System Rule is to promote public health through enhanced opportunities for prevention, detection and treatment of abuse of controlled substance without interfering with the legal medical use of those substances.

· Definition: Chronic pain is defined as pain that continues longer than 90 days, but is not caused by cancer.

· Timeliness of data: Licensed pharmacies are required to submit all prescriptions for Schedule II, III, or IV to the Department of Health database, at least once a week. (Some states require daily uploads.)

· Reporting by dispensing physicians: Prescribers who dispense controlled substances to their patients must also submit reports, like pharmacy reports, to the Department of Health database. Reporting is not required for drugs that are administered directly to a patient or drugs that are dispensed at a licensed facility if the quantity is limited to an amount adequate to treat the patient for a maximum of 48 hours.

· Registration Required: All Vermont prescribers of controlled substances must register with the Department of Health to access the VPMS system. The rules also require health care providers who practice in other states to register with the VPMS if they treat Vermont patients or if their state has entered an active reciprocal agreement for data sharing with the VPMS.

· VPMS Queries Required: VPMS queries are required in the following circumstances:

1. The first time an opioid Schedule II, III, or IV controlled substance is prescribed to treat chronic pain;
2. When starting a patient on a Schedule II, III, or IV controlled substance for non-palliative, long-term pain therapy of 90 days or more;
3. Prior to writing a replacement prescription for a Schedule II, III, or IV controlled substance;
4. At least annually for patients who are receiving ongoing treatment with an opioid Schedule II, III, or IV controlled substance
5. When prescribing a Schedule II, III, or IV controlled substance to treat acute pain for a duration of longer than 21 days; (New)
6. In an Emergency Department or Urgent Care setting (New);
§ When a patient requests an opioid prescription for chronic pain;
§ When a patient requests an extension of a current opioid prescription for acute pain from an Emergency Department or Urgent Care prescriber;
§ Before prescribing an opioid for longer than 10 days;
7. Prior to prescribing buprenorphine or a drug containing buprenorphine for the first time and no fewer than two times annually thereafter and prior to writing a replacement prescription. (New)

· Buprenorphine Dosage Limits: Prescribers must obtain prior approval from the DVHA Chief Medical Officer, Medical Director or designee prior to prescribing buprenorphine or a drug containing buprenorphine that exceeds the dosage threshold approved by the Vermont Medicaid Drug Utilization Review Board and published in the DVHA Preferred Drug List.(New)

· Delegates: Prescribers may designate a delegate or delegates to access and query the VPMS system.

1. Delegates must register under a registered prescriber in order to access and query the VPMS system;
2. Information requested by a delegate must be for the purpose of providing treatment to a bona fide current patient of the prescriber
3. Delegates must notify the prescriber of the findings of the query prior to the prescriber's writing a new prescription for controlled substances, if the query indicates that the patient has visited multiple pharmacies or that there is other activity indicating that the patient is receiving controlled substances unrelated to the prescriber's treatment plan.

(VMS Note: The Department of Health has not been able to register delegates or residents to enable them to access the VPMS since approximately November of 2013. Until the new VPMS vendor's system is functioning, hopefully sometime in 2015, the Department of Health will not be able to register new delegates for physicians or to register residents in training.)

· Correcting Errors in the Database: Prescribers may submit a request to correct erroneous information in the VPMS database to the VPMS program manager. If the pharmacy concurs that the data should be corrected, the pharmacy shall correct the data. If the pharmacy does not concur, the Department of Health will refer the prescriber to the reporting pharmacy. The rule does not include an appeal process.

· Enforcement: The Department will notify the prescriber and licensing board if a patient has filled a prescription written by a prescriber who is not a registered user of VPMS; prescribers are subject to sanctions by their licensing authority.

· Training: Training will be offered to prescribers on how to use the VPMS and how to use the information received from the VPMS.

VMS Potential Concerns and Questions about the VPMS Rule

· Should the VPMS Rule expressly exclude palliative care, hospice or other end-of-life care?
· Physicians who dispense controlled substances to their patients in their offices are required to submit data reports to the Department of Health, unless the controlled substance is administered directly to the patient or is dispensed at a facility licensed by the Department of Health if the amount is adequate to treat for a maximum of 48 hours.
· Are the new VPMS querying requirements appropriate?
o Prescribing a controlled substance to treat acute pain for longer than 21 days'
o Prescribing a controlled substance in an emergency department or urgent care setting
§ When a patient requests an opioid prescription for chronic pain;
§ When a patient requests an extension of a current opioid prescription for acute pain, or
§ Before prescribing an opioid for longer than 10 days;
o Prior to prescribing buprenorphine or a drug containing buprenorphine for the first time and at least twice a year.

The Department of Health is accepting written comments through December 29, 2014.

The Department of Health will hold a public hearing
December 19, 2014 at 2 pm
Department of Health, 108 Cherry Street, Burlington, Conference Room 3-B.