14b Hublet CORRECTED VERSION For Pdf 4 10 14x 299315

User Manual: 14B

Open the PDF directly: View PDF .
Page Count: 14

Report to

The Vermont Legislature

Increasing Access to Opioid Addiction Treatment

In Accordance with Act 75, 2013, Section 14b

An Act Relating to Strengthening Vermont’s Response to

Opioid Addiction and Methamphetamine Abuse

Submitted to: House Committees on Health Care, on Human Services

and on Judiciary

Senate Committees on Health and Welfare and on

Judiciary

Submitted by: Harry Chen, M.D.

Commissioner of Health

Prepared by: Barbara Cimaglio

Deputy Commissioner

Report Date: April 10, 2014*

*This report, originally submitted to the Legislature on January 15, 2014, had an inaccurate

statement on page 4 referring to the increased incidence of heroin use in Vermont. The report

should have stated that the number of people receiving treatment in the ADAP system of care for

heroin addiction increased by 35% from 2011 to 2012. This report was corrected and resubmitted

April 10, 2014. The Vermont Department of Health regrets any confusion this may have created.

108 Cherry Street

PO Box 70

Burlington, VT 05402

healthvermont.gov

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 2

Index

Introduction…………………………………………………………………………………..3

Vermont’s Challenge…………………………………………………………………………3

Vermont’s System of Opioid Addiction Services…………………………………………....4

Options for Expanding Access to Treatment ………………………………………………..6

Recommendations and Conclusions…………………………………………………………10

Appendix 1 - Physician Office as “Medication Unit”……………………………………….11

Appendix II - Pharmacy as “Medication Unit”……………………………………………..12

Endnotes……………………………………………………………………………………..13

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 3

Executive Summary

Increasing Access to Opioid Addiction Treatment

Act 75, Sec. 14b

April 10, 2014

Section 14b of Act 75, an act relating to strengthening Vermont’s response to opioid addiction

and methamphetamine abuse, calls for the Vermont Department of Health (VDH) to study how

Vermont can increase access to opioid treatment. Specifically, the Act directs an exploration of

how to increase access by establishing a program whereby state-licensed physicians who are

affiliated with a licensed opioid maintenance treatment program may provide methadone or

Suboxone (buprenorphine) to opiod-addicted people.

The report describes Vermont’s newly implemented Care Alliance for Opioid Addiction,

sometimes referred to as the Hub and Spoke system, a unique partnership between VDH’s

Division of Alcohol and Drug Abuse Programs (ADAP) and the Department of Vermont Health

Access’s Blueprint for Health. It explains the structure and function of the system, the clinical

support services that are an inherent component of treatment and the different federal laws and

regulations that apply to the administration of methadone and Suboxone.

The intent of the report is to improve access to opioid addiction treatment for people who are

geographically distanced from methadone treatment hubs. The options for increasing methadone

dosing sites in local physicians’ offices or pharmacies are discussed as are the federal regulatory

requirements associated with each. In spite of the advantages of increasing access to addiction

treatment, the regulatory hurdles would most likely make pursuit of these options impractical at

this time.

The report concludes that because the Alliance system is new, it is not possible to quantify any

regional unmet need. Until the system has some operational history, it will not be possible to

determine if the system’s capacity is adequate to meet the needs of Vermonter’s. The report

recommends that no efforts to pursue service expansion should be pursued at this time.

No new legislation is recommended

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 4

Increasing Access to Opioid Addiction Treatment

Act 75, Sec. 14b

April 10, 2014

Introduction

In 2013, the Vermont General Assembly passed Act 75, an act relating to strengthening

Vermont’s response to opioid addiction and methamphetamine abuse. The intent of the Act is to

provide a comprehensive approach to combatting opioid addiction and methamphetamine abuse

in Vermont through strategies that address prevention, treatment, and recovery. Section 14b of

the Act addresses access to treatment and requires the Vermont Department of Health (VDH) to

study how Vermont can increase access to opioid treatment by establishing a program whereby

state-licensed physicians who are affiliated with a licensed opioid maintenance treatment

program may provide methadone or Suboxone to opioid-addicted people. In Vermont’s current

treatment system, methadone cannot be dispensed by community physicians; methadone can

only be dispensed at Hubs, discussed below, formerly known as methadone clinics. The issue to

be studied would enable licensed physicians to prescribe methadone outside of a Hub under strict

federal regulations. This report summarizes the Department’s research on this issue and presents

recommendations for future actions. As discussed in the report, VDH does not recommend any

legislative or rulemaking at this time.

Vermont’s Challenge

Prescription and illegal opioid drug abuse is a major public health problem in Vermont. In 2011,

Vermont had the second highest per capita rate of all states for admissions to treatment for

prescription opiates, with only Maine being higheri. The majority (57%) of these admissions

were young people 20 to 29 years old.ii In 2006, other opiates, including oxycontin and other

prescription opioids, surpassed heroin as the primary source of opioid addiction for people

receiving treatment at programs funded by the Division of Alcohol and Drug Abuse Programs

(ADAP) at VDH. Furthermore, the number of people seeking and in treatment for addiction to

other opiates has continued to increase each year (Figure I.). Between 2011 and 2012, the

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment

5

number of people receiving treatment in the ADAP system of care for heroin addiction increased

by 35%. The challenge for Vermont is to develop a service system that has the capacity to

respond to opioid dependence and addiction.

Figure 1: Treatment for Opioid Use by State Fiscal Year (Vermont)

Vermont’s System of Opioid Addiction Services

A December 15, 2013 legislative report jointly written and submitted by VDH and the

Department of Vermont Health Access (DVHA) reviews the history of opioid treatment in

Vermont and discusses evolution of the current system of treatment including outpatient and

residential services, and a new initiative known as the Care Alliance for Opiod Addiction

(sometimes referred to as the Hub and Spoke system). That report, titled Opiod Addiction

Treatment Programs, discusses the evolution of the newly implemented system of opioid

dependence treatment and remaining policy and operational issues that need to be resolved in

order for the system to respond to the demand for treatment.

1

The focus of this report is to study

the feasibility and merits of expanding the system to improve statewide access to methadone

treatment.

1

Available at Vermont Legislative Council’s website. at

http://www.leg.state.vt.us/reports/2013ExternalReports/295237.pdf

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 6

Implementation of the Care Alliance

The implementation of the Care Alliance initiative began in 2013 as a unique partnership

between ADAP and the DVHA/Blueprint for Health. It is designed to expand the capacity of

both the methadone treatment programs and office-based treatment services for buprenorphine

by creating a coordinated, systemic response to the complex issues of opiate and other addictions

in Vermont. Integral to this system is the delivery of Medication Assisted Therapy (MAT). The

definitions of MAT and other key components of the system follow:

Medication Assisted Therapy (MAT) is the use of the addiction treatment medications

methadone and buprenorphine in combination with counseling and behavioral therapies,

to provide a whole patient approach to the treatment of opioid addiction. MAT in

Vermont is delivered through an integrated treatment model, known as the Hub and

Spoke. It relies on the strengths of the specialty methadone addiction treatment clinics

(Hubs), the physicians who prescribe buprenorphine in office-based settings (Spokes),

and the local Blueprint Community Health Teams and medical home infrastructure.

A HUB is a regional Opioid Treatment Program (OTP) responsible for coordinating care

and support services for patients who have complex addictions and co-occurring

substance abuse and mental health conditions. Vermont now has five regional Hubs and

seven Hub dispensing sites. Patients who need methadone must be treated in a Hub due to

federal regulations. Hubs dispense methadone under carefully controlled, observed and

regulated conditions. Patients who need buprenorphine, on the other hand, may be treated

at a Hub or may be treated in an office based practice, depending on their clinical profile

and addiction history. Their buprenorphine can either be dispensed or prescribed.

Vermont’s five regional Hubs replace the state’s former methadone clinics. Hubs serve as

the regional consultants and subject matter experts on opioid dependence and treatment,

and provide consultation and support to the office-based physicians (Spokes), essentially

linking the two previously separate systems of care.

A Spoke is a team of health care professionals providing ongoing care for patients

receiving buprenorphine in in Office Based Opioid Treatment Programs (OBOT). Spokes

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 7

do not dispense methadone. The Spoke system provides buprenorphine MAT to patients

who are less clinically complex than the patients who must receive buprenorphine in the

Hubs. A team of collaborating health and addictions professionals monitor adherence to

treatment, coordinate access to recovery supports, and provide counseling, contingency

management, and case management services to individuals receiving treatment.

Options for Expanding Access to Treatment

Because of the health, safety, economic and social costs of opioid addiction, it is essential that

people with opioid dependence have access to appropriate treatment. In spite of the

implementation of the Hub and Spoke system, there are areas of the state where access to Hubs is

difficult. For example, even with the opening of the West Ridge Addiction Treatment Center in

Rutland, Bennington will continue to be one hour away from its closest Hub. This creates access

challenges for people who live in the Bennington area and for whom methadone is the preferred

MAT. Act 75 Section 14b requires an evaluation of the feasibility of having some licensed

physicians dispense methadone through a mechanism the federal government calls Medication

Units. Throughout this report, the term Hublet will be used to refer to what the federal

government calls Medication Units.

Hubs, known by the federal government as Opiod Treatment Programs (OTP’s), are highly

regulated by the federal Drug Enforcement Agency (DEA) and the Substance Abuse and Mental

Health Services Administration (SAMHSA). They must also be approved by the State Opioid

Treatment Authority (SOTA), or ADAP in Vermont, and be accredited by a national

accreditation body such as The Joint Commission, or Commission on Accreditation of

Rehabilitation Facilities (CARF) or the Council on Accreditation. Treatment requirements are

prescribed by federal regulations, 42 CFR part 8iii, and state rules iv. Medications must be

dispensed in a highly controlled manner with any decrease in treatment structure determined by

factors including behavioral stability, treatment engagement/compliance and response, and

required time in treatment. The storage, security, safe handling and record keeping requirements

are highly regulated and reviewed by the DEA to ensure compliance with their requirements.

Opioid Treatment Programs (OTP’s) require verification of a valid DEA number prior to

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 8

ordering stock medications, as well as approval by the SOTA and SAMHSA prior to dispensing

any opioid medications.

MAT medications through OTP’s are not provided by written prescriptions. Rather, the

medications are dispensed under physician orders within a clinic setting, similar to a day hospital

type setting. Because the medication is dispensed rather than prescribed, OTP’s are not subject

to the same patient limits that office-based physicians who prescribe buprenorphine are subject

to under the federal law, DATA 2000.

One option for Vermont to increase access to methadone treatment for people who don’t live

near Hubs would be to create satellite dosing sites called Hublets. Federal law provides two

options for establishing Hublets, but there are many federal requirements for each option. The

options are as follows:

Option 1 - Physician Office as Hublet

One option would be for the medicato be a state-licensed physician’s office. There are two

models for implementing the physician office option:

1. The physician office receives the medication daily but does not store any medications

on site. The medications are delivered daily to the medication unit and are dispensed

at the medication unit the same day. Any unused medications are returned to the Hub

and accounted for on the same day.

2. The physician office receives the medication from the Hub and stores it on site for

daily dispensing. The medications are accounted for at the physician office and stored

according to DEA regulations.

Option 2 – Pharmacy as Hublet

Another option would be the use of a state-licensed pharmacy as the medication unit. The

same models discussed above could be used with either daily transport of the medication

from the Hub to the pharmacy, or storage of the medication at the pharmacy.

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 9

In either of the above two options, a Hublet can only provide two services, dosing and toxicology

testing (urine screens). All other psychosocial support services ancillary to the provision of MAT

must be provided by the Hub. Appendices I and II provide graphic presentations of the

operations of these two dispensing options.

Regulatory Challenges for the Development of Hublets

In spite of the potential for improving access to methadone treatment by creating Hublets, there

are federal regulatory and operational challenges that may make pursuit of this strategy

impractical. They are as follows:

1. Limits on Hub Services Federal rules regulating medication units limit the services

they can provide to dispensing medication and conducting urine screening. Other

ancillary and clinically essential support and counseling services must be provided by a

Hub. Since these ancillary services are a requirement for a Hub, the individual receiving

medication from a Hublet would need to travel to a Hub for ancillary services. As a

result, the convenience of a local Hublet for dispensing medication is offset by the

required travel to a Hub for ancillary services. This fact renders the Hublet option an

imperfect strategy for improving access to addiction treatment services.

2. Transport and Storage of Medication Federal regulations require that all medications

must be purchased by and initially delivered to an OTP (Hub). The federal requirement

for daily transport of medication to a Hublet and back to a Hub creates costly operational

and logistical disincentives to implement this treatment model. Transport security

arrangements in the form of a Chain of Custody agreement would need to be formalized

to implement this model. Physicians who would choose the option of storing the

medication on site would need to comply with federal DEA requirements for safety,

storage and dispensing of Schedule II and III narcotics. And, unlike pharmacies,

physician offices would need to make environmental modifications to meet federal

storage and safety specifications. The costs associated with this would most likely be

prohibitive.

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 10

3. Provider liability and costs Perhaps the most significant barrier to the development of

Hublets would be the hesitancy of physicians and pharmacies to assume the

responsibilities, costs and risks of doing so. Unlike in the Office Based Opioid Treatment

(OBOT) model for prescribing buprenorphine where a physician conducts an office visit

and writes a prescription, a Hublet would require the physician office to dispense

medications and witness dosing. Other burdensome requirements Hublets would face

include:

a. As a dispensing site, the need to dispense during 7 days a week;

b. The need to coordinate dispensing and assume liability for actions on their

premises without authority and responsibility for the individual’s care;

c. The need to perform toxicology screening (urine screening) in compliance with

all applicable DEA laws and regulations.

d. The costs of additional personnel, insurance and environmental modifications to

ensure safe and secure storage of medications.

Potential Benefits to the Development of “Medication Units” or “Hublets”

In spite of the regulatory and logistical challenges, there would be some benefits to

implementing Hublets as a means of expanding access to MAT treatment. For individuals with

co-occurring medical or psychiatric conditions, the ability to receive medication and health care

from a local physician would likely yield improved management of health problems and

compliance with treatment recommendations. In addition to decreasing barriers to care, local

dosing would allow for improved engagement in other aspects of the individuals’ lives

previously lost to transportation time. Although the individual would be required to travel to a

Hub for ancillary services, local dosing would decrease the travel. The stability of the patient,

time in treatment and a variety of other clinical factors will have an impact on the frequency with

which individuals need to return to Hubs. The key system development and policy issues are

whether or not the potential benefits are worth the onerous regulatory and operational

requirements inherent in a Hublet model.

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 11

Recommendations and Conclusions

The concern about ensuring that Vermonters with opioid dependence have access to MAT

statewide is valid. In spite of the newly implemented Hub and Spoke system, there continue to

be some areas that are geographically isolated from Hubs. This is particularly challenging for

individuals who need methadone treatment, because, unlike buprenorphine, methadone can

currently only be dispensed at Hubs in Vermont. State and federal regulations would make

feasible the creation of medication units, or Hublets, in Vermont, and would move methadone

dispensing closer to individuals for whom methadone is the clinically preferred MAT. The state

and federal regulations for creating and operating such sites, however, are onerous.

Because the Hub and Spoke system is new to Vermont, it is difficult to project how adequately

this system will meet the needs of individuals needing MAT. Over time, the monitoring of

access and waitlists will show any geographic patterns of unmet need. The significant

investments in Hublet medication units would be premature prior to a reasonable assessment of

the effectiveness of the newly implemented Hub and Spoke System in meeting treatment needs.

It is therefore recommended that Vermont not pursue the creation of Hublets until any significant

unmet need can be documented. This conclusion implies that no Vermont legislative or

regulatory action be pursued at this time.

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 12

Appendix 1

Physician Office as “Medication Unit”

Medication orderedfrom

pharmaceuticalcompany,

shippedto"hub"andis

logged/accountedfor.

Model1A

Medication packagedand

driventophysicianoffice

fordispensing.

Packaging/remainingmedstransported

backto"hub"afterdispensinghours

completedandaccountedforathub.

Repeat daily7

daysaweek

Individualdispensingmedicationmustbelegallyauthorized/credentialed

todoso(nurse,physician,pharmacist)

Model 1B

Dailymedicationtransporttophysicianoffice

Medi catonstoredatphysicianoffice

Medicationordered/arrivesat"hub"

andislogged/accountedfor.

Medicationpackagedand

driventophysician office

fordispensing.

Medication accountedfor,storedanddispensedat

physicianofficefollowingallDEArequiredprotocols

regardingDEAsafety/securityrequirements.

Medicationdispenseddaily

andaccountedforfollowing

dosing7daysaweek.

Remainingmedicationand/or

medicationlogisreturrnedto

"hub"andlogged/verified.

Repeat atpredeterminedintervals.

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 13

Appendix II

Pharmacy as “Medication Unit”

Model 2A

DailyMedication transportedtopharmacy

Medication orderedfrompharmaceuticalcompany,

shippedto"hub"andislogged/accountedfor.

Medi cationpackaged anddrivento

physicianofficefordispensing

Packaging/remaingmeds transportedbackto"hub"after

dispensinghourscompletedandaccountedforathub.

Repeatdaily7daysaweek. Pharmacisttodispense

medication.

Model2B

Medicati on storedatpharmacy

Medicati onordered/arrivesat

"hub"andislogged/accounted

for.

Medicati on packaged

anddriventopharmacy

fordispensing.

Medicati onaccountedfor,stored anddispensedatpharmacy

followingallDEArequiredprotocolsregardingDEA

safety/securityrequirements

Medi cationdispenseddailyand

accounted forfollowingdosing

7daysaweek.

Remainingmedicationand/or

medicationlogisreturnedto

"hub" andlogged/verified.

Repeatatpredeterminedintervals

Vermont Department of Health

Increasing Access to Opioid Addiction Treatment 14

Endnotes

i Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration,

Treatment Episode Data Set (TEDS). Data received through 10.10.11.

ii Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration,

Treatment Episode Data Set (TEDS). Data received through 10.10.11.

iii 42 CFR, Part 8, Federal Opioid Treatment Standards. Federal Register, Volume 66, No. 11, January 17, 2001,

Rules and Regulations.

iv http://healthvermont.gov/regs/documents/opioid_dependence_rule.pdf