Transcript
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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
Phase 1 Applications
Application Review
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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
Phase 1 Applications
Application Review
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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
Phase 1 Applications
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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Phase 2 Applications
ICF Independent Expert Review
Selection Committee Review
Executive Director Decisions
Initial CSI Background Checks
DispensarySelection Process
Verification Phase RMDs open
InspectionPhase
Phase 1 Applications
Application Review
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Selection Committee Review
• 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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Phase 2 Applications
ICF Independent Expert Review
Selection Committee Review
Executive Director Decisions
Initial CSI Background Checks
DispensarySelection Process
Verification Phase RMDs open
InspectionPhase
Phase 1 Applications
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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Phase 2 Applications
ICF Independent Expert Review
Selection Committee Review
Executive Director Decisions
Initial CSI Background Checks
DispensarySelection Process
Verification Phase RMDs open
InspectionPhase
Phase 1 Applications
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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Phase 2 Applications
ICF Independent Expert Review
Selection Committee Review
Executive Director Decisions
Initial CSI Background Checks
DispensarySelection Process
Verification Phase RMDs open
InspectionPhase
Phase 1 Applications
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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Phase 2 Applications
ICF Independent Expert Review
Selection Committee Review
Executive Director Decisions
Initial CSI Background Checks
Recap: DispensarySelection Process
Verification Phase RMDs open
InspectionPhase
Phase 1 Applications
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
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