PA Medical Marijuana Program

DOH Finalizes Temporary Regulations for Clinical Registrants and Academic Clinical Research Centers

Posted by J. Nicole Martin on March 16, 2018
PA Medical Marijuana Program / No Comments

The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers (ACRC) in Pennsylvania (“Temporary Regulations”). The Clinical Registrant/ACRC relationship was first developed in Pennsylvania with a specific focus on research.  A Clinical Registrant is a unique category of Medical Marijuana Organization under Pennsylvania law that is granted a permit to act as both a grower/processor and dispensary. An ACRC is “an accredited medical school” in Pennsylvania that “operates or partners with an acute care hospital licensed and operating” in Pennsylvania. The Temporary Regulations require Clinical Registrants and ACRCs to enter into Research Contracts together and provide some broad guidance about the content of those written agreements. Additionally, the Temporary Regulations address certification of ACRCs, capital requirements, approvals for clinical registrants, and the process for Clinical Registrant applicants who wish to convert their already issued grower/processor or dispensary permits to Clinical Registrant permits.

For more information about the Temporary Regulations or the Medical Marijuana Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.

J. Nicole Martin

J. Nicole Martin

Nicole assists accountable care organizations, health care systems, long term care providers (e.g., skilled nursing facilities, continuing care retirement communities), behavioral and mental health providers, medical device manufacturers, physician practices, and pharmacies with their compliance, regulatory, and transactional needs. Nicole’s practice includes providing clients with counsel regarding telehealth laws, HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws.

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PA DOH Releases Proposed Temporary Medical Marijuana Regulations for Doctors

Posted by J. Nicole Martin on April 12, 2017
DOH, PA Medical Marijuana Program / No Comments

Yesterday the Department of Health (DOH) released the much anticipated proposed temporary regulations for physicians that among other items, set forth requirements regarding: the physician registry, the completion by physicians of a four-hour training course, and issuing patient certifications, as well as prohibitions, including for example, a prohibition against advertising a physician’s ability to prescribe cannabis under the Pennsylvania Medical Marijuana Act (Act 16). As the proposed regulations are not yet effective, DOH will accept comments on them until April 20, 2017. More information about these draft regulations appears on the DOH website, and they are available here.

J. Nicole Martin

J. Nicole Martin

Nicole assists accountable care organizations, health care systems, long term care providers (e.g., skilled nursing facilities, continuing care retirement communities), behavioral and mental health providers, medical device manufacturers, physician practices, and pharmacies with their compliance, regulatory, and transactional needs. Nicole’s practice includes providing clients with counsel regarding telehealth laws, HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws.

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Pennsylvania Issues Grower/Processor and Dispensary Permit Applications for Medical Marijuana Program

Posted by Chris Raphaely on January 23, 2017
PA Medical Marijuana Program, Pennsylvania Department of Health / No Comments

filling out applicationOn January 17, 2017, the Pennsylvania Department of Health (“DOH”) released grower/processor and dispensary permit applications (“Applications”), which can be found on Pennsylvania’s Medical Marijuana Program website. DOH will accept Applications from February 20 – March 20, 2017, and will begin taking questions about the Applications on February 8, 2017. Other highlights regarding the application process are set forth below.

  • 12 grower/processor permits will be issued.
  • 27 dispensary permits will be issued.
  • Two grower/process permits will be issued in each of the six regions in the Commonwealth.
  • The maximum number of dispensary locations in each region (by county) is set forth in the Applications’ instructions on page two.
  • Each applicant will receive a weighted score out of a maximum number of 1,000 points.
  • The Applications require information regarding, among other items, an applicant’s diversity plan, background information about principals, financial backers, operators and employees, capital sufficiency, an applicant’s plan of operation and an operational timetable, and an applicant’s anticipated community impact.
  • Principals means “an officer, director or person who directly or beneficially owns securities of an applicant or permittee, or a person who has a controlling interest in an applicant or permittee or who has the ability to elect the majority of the board of directors of an applicant or permittee or otherwise control an applicant or permittee, other than a financial institution.”
  • Financial backers means “an investor, mortgagee, bondholder, note holder, or other source of equity, capital or other assets other than a financial institution.”
  • Financial institution means “a bank, a National banking association, a bank and trust company, a trust company, a savings and loan association, a building and loan association, a mutual savings bank, a credit union or a savings bank.”
  • The non-refundable application fee for growers/processors is $10,000, and the initial permit fee for growers/processors is $200,000 (both payable with the Application).
  • The non-refundable application fee for dispensaries is $5,000, and the initial permit fee for dispensaries is $30,000 per dispensary location, for up to $90,000 (both payable with the Application).
  • A rejected Application would be returned to an applicant with the initial permit fee.
  • DOH may reject an Application that is received after March 20, 2017 or without a U.S. Postal Form 3817, which is required as proof of an applicant’s mailing date.
  • The DOH will post FAQs regarding the Applications on its website.

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Chris Raphaely

Chris Raphaely

Chris joined Cozen O’Connor’s Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Prior to joining the firm, Chris served as deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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