Part of a "first Thursdays" fall webinar series hosted by Behavioral Health Association of Providers, Epstein Becker & Green, P.C., and Nelson Hardiman, LLP. Presented by: Francesca R. Ozinal – Associate, Epstein Becker Green Andrew Martin – Chief Operating Officer, Behavioral Health Association of Providers Despite reports identifying medication-assisted treatment (MAT) as a critical element of evidence-based treatment, confusion concerning who may dispense, associated compliance requirements, and the relationship between MAT provision and behavioral health providers continues to impede access to MAT. This webinar will review key licensing and operational issues concerning the various types of MAT, including buprenorphine, naltrexone, and methadone, as well as misperceptions and key compliance issues in instituting MAT. More info: https://www.ebglaw.com/events/mystified-by-mat-navigating-the-changing-regulatory-landscape-around-medication-assisted-treatment/ These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.

1. Mystified by MAT? Navigating the Changing
Regulatory Landscape Around Medication
Assisted Treatment
November 1, 2018

2. 2
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3. Presented by
3
Francesca Ozinal
Epstein Becker Green
FOzinal@ebglaw.com
Andrew Martin
Behavioral Health Association
of Providers
amartin@bhap.us

4. 4
Agenda
 What is Medication Assisted Therapies (MAT)
 Type of medications used with MAT
 Regulations pertaining to MAT
 Process of being approved for MAT
 Legislative climate surrounding MAT
 Medical controversy surrounding MAT
 Therapeutic value controversy
 Medicare and Medicaid reimbursement
 Continuum of Care

5. 5
What is MAT?
 SAMHSA
• FDA-approved medications
• In combination with:
o Counseling
o Behavioral therapies
• To provide a whole-patient approach to
the treatment of substance use disorders

6. 6
How MAT is Supposed to Work
 Medications combined with counseling and
behavioral therapies
 MAT can help to sustain recovery from
substance use disorders
+

7. 7
 Member of the opioid family
 Substitute medication in treatment of morphine,
heroin, and narcotic painkillers
 Lessens the painful symptoms of withdrawal
 Blocks euphoric effects of opiate drug use
 Common forms include pills, liquid, wafers
 Intended to keep patients in treatment programs
longer
Types of MAT Medication
Methadone

8. 8
 Member of the opioid family
 Substitute medication in treatment of morphine, heroin, and
narcotic painkillers
 Reduces symptoms of withdrawal and cravings
 Blocks euphoric effects of opiate drug use
 Common forms include sublingual tablets, films, nasal spray
 Intended to keep patients in treatment programs longer and
outside of structured clinics
Types of MAT Medication
Buprenorphine

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 Blocks the euphoric effects of opiates and
alcohol
 Reduces the desire to use opioids and
alcohol
 Common forms include pills and as an
injectable
 Intended to keep patients in treatment
programs longer
Types of MAT Medication
Naltrexone

10. 10
Regulations Pertaining to MAT
Certification of
Opioid Treatment
Programs
(42 CFR 8)
Drug Addiction
Treatment Act
of 2000
Regulatory agencies
involved: DEA,
SAMHSA, HHS, DEA
and states
Recordkeeping
requirements

11. 11
Modify DEA Registration
Federal Opioid Treatment Standards
Accreditation
Certification
State Licensure
Process of being approved for MAT for OTPs
OTPs = methadone clinics and outpatient / residential treatment programs

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What is the regulatory framework that governs this
approval process?
How do physicians qualify for a waiver?
What limitations must a waivered physician adhere
to?
Does the new law impact waivered physicians?
Are states involved in the process of approving
physicians?
Are there any exceptions to the registration
requirements?
Process of being approved for MAT for physicians

13. 13
Process of being approved for MAT for other
provider types and for patients
Physician Assistants
and Nurse
Practitioners
Patients

14. 14
 Legislation is including MAT as a
primary intervention to OUDs
 Lawmakers lack understanding
• Substance use disorders
• Biology, environment, psychology,
sociology
• One-Cure-Fits-All does not exist
 Biological solution is well
understood
 Therapeutic necessity is not well
understood
Legislative Climate Surrounding MAT
Is MAT the Quick-Fix for the Opioid Crisis?

15. 15
 President Trump’s 21st Century
Cures Act earmarked $1 billion to
substance use dependence
treatment
 Medical community supports the
biology component
 Therapeutic community does not
have a unified voice
Legislative Climate Surrounding MAT
Big Pharmaceuticals Pushing for MAT
Image from www.LobbyFacts.eu

16. 16
 Transparency with patient
• Risks
• Rewards
• Expectations
• Patient decides
 Drug Addiction Treatment Act of 2000
• 8 hours training, 1 other criteria
• 30 patients
 HR6
• 100 patients
• Allows other health care providers
to prescribe
Legislative Climate Surrounding MAT
Physician Training and Regulation Needs

17. 17
Medical Controversy Surrounding MAT
 Methadone and Buprenorphine
• Opioid replacement medications
 Just a more acceptable form of
substance dependence?
 Evidence:
• People stay in treatment longer
• Have better outcomes
 Challenges
• How long does a patient remain
on medications?
• How long does a patient remain in
counseling and behavioral
therapy?

18. 18
Medical Controversy Surrounding MAT (cont.)
 Naltrexone
 Interferes with abstinence?
 Hi cost
 Is impact worth the expense?

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 Large drop-out rates for patients on
opioid replacement maintenance
programs
 Patients participating in opioid
replacement maintenance programs stay
in treatment longer and have better
outcomes
 Polarized view of MAT
• MAT is not abstinence and is not
enough of a recovery commitment
• Excellent tool to get past withdrawal
and cravings
Therapeutic Value Controversy
Abstinence vs. Maintenance

20. 20
 Harm reduction betters health, society and economy
 Reducing substance use increases quality of life
 Harm reduction may be the best one can hope for
 Even moderation in the use of addictive substances does not
constitute recovery
Therapeutic Value Controversy
Harm Reduction vs. Abstinence

21. 21
• Coverage of opioid treatment programs
• Expanded access to telehealth services
• Implements demonstration program to
increase access to evidence-based outpatient
treatment
Medicare
• Extends the enhanced match offered to
states for health home programs
• Expanded access to telehealth services
• Streamlined options for states to cover
services for individuals in residential
treatment facilities
Medicaid
HR 6 changes to Medicare and Medicaid coverage and
reimbursement

22. 22
Continuum of Care
 Have to learn how to accommodate MAT
 Legislation is here, or is coming
 Governmental stance is embracing MAT
 Government insurance will require MAT
 Commercial insurance will follow

23. Presented by
23
Francesca Ozinal
Epstein Becker Green
FOzinal@ebglaw.com
Andrew Martin
Behavioral Health Association
of Providers
amartin@bhap.us
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