Presentation Transcript

1. Massachusetts Medical Use of Marijuana Program Process Update

   Ensuring Patient Access and Safety
2. Implementing the Will of Voters November 2012 ballot initiative passed with 63% of the vote 349 of 351 cities and towns DPH reviewed best practices from 17 states. 25 stakeholder meetings, as well as listening sessions and public hearings were held.
3. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
4. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
5. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
6. 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
7. Initial Background Checks Searches Included: National Practitioner’s database and Professional Licensing Databases Fraud and Abuse Control Information Systems: 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: 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
8. 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 scorewasonly one of many factors that the Selection Committee considered to ensure that RMDs serve the public interest
9. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
10. Selection CommitteeReview 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: independent expert review geographic distribution patient access drug diversion Identified highly qualified, qualified, and not-qualified applicants
11. Selection Committee GIS Mapping Demo
12. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
13. Executive Director Review CSI Background Check Results Executive Director Provisional Decisions 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 Committee Recommendations
14. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
15. Enhanced Background and Verification Checks DPH and CSI conducted enhanced verification check on 20 provisional applicants, reviewing: Each applicant’s business and operational plans Information disclosed and surfaced in any background checks 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
16. 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
17. Provisional Certificatesof Registration DPH issuing Provisional Certificates of Registration only to those deemed suitable to advance to inspection phase Applicants may now beginprocess of setting up operations Program now enters Inspection Phase
18. Provisional Certifications 97% of the state’s population within 30 miles of a provisionally certified RMD Alternative Therapies Group, Inc. (Salem) Bay State Relief, Inc. dba Milford Medicinals, Inc. (Milford) Central Ave Compassionate Care, Inc. (Ayer) Ermont, Inc. (Quincy) Garden Remedies, Inc. (Newton) Healthy Pharms, Inc. (Haverhill) In Good Health, Inc. (Brockton) New England Treatment Access, Inc. (Brookline) New England Treatment Access, Inc. (Northampton) Patriot Care Corp. (Lowell) William Noyes Webster Foundation, Inc. (Dennis)
19. Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
20. Inspection Phase Begins DPH will conduct inspections on grow-readiness, processing,and retail-readinessto 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 requirementsbefore DPH issues final Certificates of Registration
21. 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
22. Additional Oversight RMDs will be regulated by appropriate local, state, and federal authorities, including: MassachusettsAttorney General and Secretary of the Commonwealth, who oversee non-profits The IRS, which oversees federal employee and employer tax issues Board of Registration in Medicine, which oversees licensing and practicing of medicine for physicians 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.
23. Recap: Dispensary Selection Process Phase 1 Applications Application Review ICF Independent Expert Review Selection Committee Review Executive Director Decisions Phase 2 Applications Inspection Phase Verification Phase RMDs open Initial CSI Background Checks
24. Upcoming Timelines Applicants for Open Counties Projected Timeline for Next Application Round

25. Massachusetts Medical Use of MarijuanaProgram

    Ensuring Patient Access and Safety