Marijuana Program Process Update

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Massachusetts Medical Use of

Marijuana Program Process Update

Ensuring Patient Access and Safety

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Implementing the Will of Voters

• November 2012 ballot initiative passed with• 63% of the vote• 349 of 351 cities and towns

25 stakeholder meetings, as well as listening sessions and public hearings were held.

DPH reviewed best practices from 17 states.

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Phase 2 Applications

ICF Independent Expert Review

Selection Committee Review

Executive Director Decisions

Initial CSI Background Checks

DispensarySelection Process

Verification Phase RMDs open

InspectionPhase


Application Review

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InspectionPhase


Application Review

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InspectionPhase


Application Review

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Initial Background Checks

• Applicants required to provide names of executive management team, board members, and investors; with over 600 individual names submitted

• 10 CSI investigators led national and international criminal, civil, business, and social media background checks on names as provided in the application

• Administrative, disciplinary, financial and compliance-related reviews conducted

• Close to 5,000 court searches completed

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Initial Background Checks

• Searches Included:o National Practitioner’s database and Professional Licensing

Databases

• Fraud and Abuse Control Information Systems:o With information from over 700 agency sources, including Office

of Inspector General, Food and Drug Administration, GSA, and other federal and state agencies

• Restricted Parties Search:o Office of Foreign Asset Control, Specially Designated Nationals,

Debarred Parties, U.S. Bureau of Industry and Security, Denied Entities List, FBI Fugitives List, DEA Fugitives List, Foreign Agent Registrations List

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Independent Expert Review

• 7 ICF experts reviewed applications and scored based on: •public health•security•business•non-profit management•public safety

• Each application reviewed for consistency with scoring guidelines

• An applicant’s score was only one of many factors that the Selection Committee considered to ensure that RMDs serve the public interest

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InspectionPhase


Application Review

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• Convened Selection Committee w/ diverse backgrounds in:• public health & patient care• law enforcement• municipal and community work• pharmaceuticals & drug diversion protection• non-profit management

• Evaluated applications based on:o independent expert review o geographic distributiono patient accesso drug diversion

• Identified highly qualified, qualified, and not-qualified applicants

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Selection Committee GIS Mapping Demo

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InspectionPhase


Application Review

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Executive Director Review

• Executive Director met with Selection Committee to review recommended applicants

• Some recommended applicants did not advance due to information affecting suitability, including background checks

• Executive Director chose 28 total applicants to advance at selected or alternate location.

• All applicants selected to advance were deemed qualified or highly qualified by Selection Committee

Selection CommitteeRecommendations

CSI Background Check Results

Executive DirectorProvisional Decisions

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InspectionPhase


Application Review

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Enhanced Background and Verification Checks

• DPH and CSI conducted enhanced verification check on 20 provisional applicants, reviewing:

o Each applicant’s business and operational planso Information disclosed and surfaced in any background checkso All investors, source of funds, and investments

• CSI completed 176 additional individual and corporate background checks on all investors, staff, and related companies

• DPH contacted over 200 individuals to verify applicants’ representations of local support

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Enhanced Background and Verification Checks

• Expanded background checks to affiliated entities, including those in other states

• Extended review of financial management, investors, and operational plans

• Reviewed status of relationships with host communities

• Assessed any changes since initial application

• Conducted investigative interviews with applicants to verify all information

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Provisional Certificatesof Registration

• DPH issuing Provisional Certificates of Registration only to those deemed suitable to advance to inspection phase

• Applicants may now begin process of setting up operations

• Program now enters Inspection Phase

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Provisional Certifications

1. Alternative Therapies Group, Inc. (Salem)2. Bay State Relief, Inc. dba Milford Medicinals, Inc.

(Milford)3. Central Ave Compassionate Care, Inc. (Ayer)4. Ermont, Inc. (Quincy)5. Garden Remedies, Inc. (Newton)

6. Healthy Pharms, Inc. (Haverhill)7. In Good Health, Inc. (Brockton)8. New England Treatment Access, Inc. (Brookline)9. New England Treatment Access, Inc. (Northampton)10. Patriot Care Corp. (Lowell)11. William Noyes Webster Foundation, Inc. (Dennis)

97% of the state’s population within 30 miles of a provisionally certified RMD

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InspectionPhase


Application Review

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Inspection Phase Begins

• DPH will conduct inspections on grow-readiness, processing, and retail-readiness to ensure:

- Product safety and quality - Security, storage and transportation - Responsiveness to patient needs

• Applicants must collaborate with host communities on compliance with municipal requirements

• RMDs must successfully complete all inspectional requirements before DPH issues final Certificates of Registration

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DPH Oversight of New Industry

• Manage online registration system

• Track sales and distribution• Up to 10-ounce supply

every 60 days

• Track one-to-one patient-to-caregiver requirements

• Approve and track hardship cultivations

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Additional Oversight• RMDs will be regulated by appropriate local, state, and

federal authorities, including:

o Massachusetts Attorney General and Secretary of the Commonwealth, who oversee non-profits

o The IRS, which oversees federal employee and employer tax issues

o Board of Registration in Medicine, which oversees licensing and practicing of medicine for physicians

o Local and state officials, who regulate building, zoning, and fire code compliance• Applicants will need to obtain all necessary municipal

approvals prior to receipt of a final certificate.

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Recap: DispensarySelection Process


InspectionPhase


Application Review

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Upcoming Timelines

Applicants for Open CountiesActivity Date

Kick-off application process July 9, 2014Applications due August 29, 2014Announce outcome October 2014

Activity DateAssess program, data, and patient access needs

Winter 2014-Summer 2015

Anticipated start of application process

Summer 2015

Anticipated outcomes 2016

Projected Timeline for Next Application Round

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Massachusetts Medical Use of Marijuana

Program

Ensuring Patient Access and Safety

Marijuana Program Process Update

Healthcare

selection committee

social media background

application administrative

management public safety

csi investigators

icf experts

public hearings

qualified applicants