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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJanuary 2014

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16 DE Admin. Code 4470
On October 1, 2013 (Volume 17, Issue 4), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by October 31, 2013, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
In accordance with Delaware Law, public notices regarding proposed Department of Health and Social Services (DHSS) regulations governing the State of Delaware Medical Marijuana Act were published in the Delaware State News, the News Journal and the Delaware Register of Regulations. Written comments were received on the proposed regulations during the public comment period (October 1, 2013 through October 31, 2013). Entities offering written comments included:
When appropriate, the department's proposed regulations are initially quoted exactly as they appear in the October 1, 2013 edition of the Delaware Register of Regulations. MPP's suggestions are found in the comment boxes with underscored and struck-through language being additions to or redactions from the language found in the proposed regulations.
2.0 Definitions
MPP comment: The Delaware medical marijuana law (16 Del.C. §4902A) does not define Post-Traumatic Stress Disorder (PTSD). MPP feels it is unnecessary for the department to define PTSD as it already has a clinical definition. However, if it were defined, the definition should be limited to when "a patient meets the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD), per DSM-5 or subsequent current edition." MPP is very concerned that the proposed rules' definition of PTSD goes beyond the requirement that the "patient meets the diagnostic criteria for [PTSD] … per DSM-5 or subsequent edition" by adding "including symptoms of intense physical reactions, such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating."
We recommend deleting the proposed definition of Post-Traumatic Stress Disorder found in 2.0. In the alternative, we recommend amending the definition to read:
"Post-Traumatic Stress Disorder means that a patient meets the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD), per DSM-5 or subsequent current edition., including symptoms of intense physical reactions, such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating."
Agency Response: The Agency appreciates and acknowledges these comments. The definition of PTSD was amplified in the regulations to indicate what symptoms are considered debilitating.
MPP comment: MPP strongly supports ensuring that marijuana is safe from dangerous pesticides. However, a complete ban on any pesticides is unnecessarily broad and may result in infestations that would prevent compassion centers from being viable, while driving patients to the criminal market. Maine initially had a complete ban on pesticides, but recognized earlier this year that pesticides that are so safe they are exempt from federal registration are safe for use on marijuana, with some limitations. Meanwhile, Washington state created a list of pesticides allowed on marijuana, and Colorado approved a list of pesticides that are not allowed on marijuana. We recommend that Delaware adopt essentially the same standard as was adopted in either Maine, Colorado, or Washington state. (22MRSA 2428, sub- 9, G)
We recommend revising the prohibition on pesticides. A revision based on Maine's law would read:
We also recommend revising 7.8.10 to read:
"the applicant's ability to grow marijuana without use of prohibited pesticides."
Agency Response: The Agency appreciates and acknowledges these comments, currently, the use of any pesticide on medical marijuana is prohibited. The issue of pesticide use on medical marijuana is under further study and has been referred to the Delaware Governor's Panel on Pesticide Use. When the Panel issues a recommendation, further clarification will be issued.
7.2.6 Maximum amount of compassion center inventory
MPP comment: MPP feels it is unnecessary and contrary to the purposes of the Delaware Medical Marijuana Act to limit the amount of marijuana plants and usable marijuana compassion centers may possess at any given time. These caps will greatly restrict the amount of medicine available to the patient population in Delaware, resulting in a situation where patients are forced to continue to purchase unregulated medicine from the criminal market or to suffer without a medicine that can help them and that the legislature authorized.
As explained above, however, both the existence of a strong and effective state regulatory system, and an operation's compliance with such a system, may allay the threat that an operation's size poses to federal enforcement interests. Accordingly, in exercising prosecutorial discretion, prosecutors should not consider the size or commercial nature of a marijuana operation alone as a proxy for assessing whether marijuana trafficking implicates [DOJ's] enforcement priorities. (emphasis added)
Even with the option of home cultivation, there have been major problems with shortages in New Mexico. There have been multiple instances in which New Mexico's dispensaries ("licensed producers") did not produce an adequate supply to serve all of the registered patients of the state.1 New Mexico's dispensaries were unable to meet patients' needs even when there were 17 licensed producers cultivating 95 plants. That's a total of 1,615 plants in a state that only has a little more than two times the population of Delaware.
1 Tim Korte, "New Mexico OKs fees for medical marijuana program," Bloomberg, Dec. 17, 2010. (Noting that the state was licensing eight more growers, bringing the total number to 25 and increasing mature plant limits from 95 to 150. The article noted, "Since the program started in 2007, the state has faced problems ensuring a steady supply.")
2 "Medical Marijuana Update," Drug War Chronicle, Issue #797, August 22, 2013; "New hope for sick kids: Christie eases stance on medical marijuana," The Record, August 16, 2013. (The law allows for six dispensaries, but only one has opened, and the demand has been so high that it had to close for several weeks to cultivate more marijuana. New Jersey law does not allow patients to have their own plants, and dispensaries must cultivate their own supply.)
We strongly recommend removing the possession limitation placed on compassion centers for marijuana plants and usable marijuana.
Agency Response: The Agency appreciates and acknowledges these comments, however, to address Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
MPP comment: This warning should be revised to only require marijuana to be stored in the container when it is outside the person's residence and when it is not being ingested or prepared for ingestion, pursuant to § 4919(x). The instructions the patient is given should track the language of the law to avoid misinforming patients. For a variety of reasons, it may make more sense for a patient to store marijuana in different containers than the ones they obtained from the compassion center while they are at home. Elderly patients and patients with arthritis or other problems using their hands may have problems opening and closing the containers, depending on their design. Also, they may need to separate out each dosage, just as prescriptions are often separated by each day of the week. Finally, they may cook marijuana into food, such as small cookies, that they eat over a period of time. Of course, the food would be too large to store in the original container.
We recommend amending 7.2.8.1.2 to read:
Agency Response: The Agency appreciates and acknowledges these comments, however in an effort to prevent diversion and patient protection, through proper identification of the product, Medical Marijuana should be stored in the container it was purchased, when not being prepared for ingestion or being ingested.
MPP comment: We agree with the idea of compassion center personnel receiving identification cards, but believe it would be more efficient and desirable to require the compassion centers themselves to conduct background checks and issue identification cards to all principal officers, board members, agents, volunteers, and employees. This is also what the law itself envisions. § 4918A requires the compassion center - not the state - to perform background checks on employees. In addition, the law defines "cardholder" as "a qualifying patient or a designated caregiver who has been issued and possesses a valid registry identification card" and registry identification card as "a document issued by the Department that identifies a person as a registered qualifying patient or registered designated caregiver."
"In response to the requirements of this rule, and upon the approval of the submitted application, the Department compassion center shall issue a registry photo identification card to each principal officer, board member, agent, volunteer or employee of a compassion center who is associated with a compassion center and meets the requirements under these regulations."
Agency Response: The Agency appreciates and acknowledges these comments however, to address Federal Justice Department concerns, the Delaware Medical Marijuana Office will require multi-jurisdiction background check be conducted and Medical Marijuana program office issued identification card for all individuals with access to the restricted areas of a compassion center.
MPP comment: We feel it is unnecessary to continue to delay the rulemaking for an independent testing facility, especially in light of the decision to promulgate regulations for a compassion center. State-regulated and registered medical marijuana testing facilities are openly and actively serving the medical marijuana program in Colorado. These facilities ensure that medical marijuana does not contain molds or contaminants and clearly states the percentage of various cannabinoids so patients can more easily find a strain to address their particular debilitating disease or condition.
MPP encourages the department to move forward with developing testing facility center regulations.
Agency Response: The Agency appreciates and acknowledges these comments however, considering the narrow scope of the pilot compassion center concept, opening an independent testing center would not be a financially viable option at this point. The limited volume of testing would not be enough to sustain the lab and could jeopardize the program. The program will increase the physical inspection of the Compassion Center growing process and pest control.
MPP comment: MPP feels it is unnecessary to limit the compassion center program to one pilot center. The governor and the department should move forward with implementing the letter of the law by registering one compassion center in each county, so long as qualified applicants exist.
We recommend moving forward with issuing registrations to three compassion centers (one in each county) as mandated by Delaware's medical marijuana law.
Agency Response: The Agency appreciates and acknowledges these comments however, to address Federal Justice Department concerns; the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand.
Agency Response: The Agency appreciates and acknowledges these comments, after thorough review and consultation with various stakeholders; the program is unable to incorporate all the proposed solutions.
*Agency Note - see MPP comments referenced above
Agency Response: The Agency appreciates and acknowledges these comments, after thorough review and consultation with various stakeholders; the program is unable to incorporate all the proposed solutions.
I'm a husband and caregiver to my wife, Avanda. We've been married for over 25 years. Avanda had been a Nurse for most of her career but had to hang up the stethoscope a few years ago because of chronic pain in her neck and lower back region. She is 61 years old and now on permanent disability. For the last 7-10 years, she has had to live with the pain of degenerative disc disease in her neck and lower back. She had a disc infusion on her neck two years ago which provided some relief but the surgery failed and she has to have the plate and screws in her neck re-adjusted. She is in the process of scheduling a disc infusion in her lower back but a preexisting condition in the lower back needs surgery before the disc infusion surgery. She also suffers from osteoarthritis. The disfigurement and the pain of this disease is a daily constant reminder. Her cornucopia of pain medications, include Percocet, Morphine, Neurontin, Valium and Flexaril. Being a nurse, she understands the pitfalls (addiction) of these pain pills and tries everything in her power to limit her intake of these meds. However, some days, it's all she can do to get out of bed without the aid of a Percocet to help and knock down some of the pain. Her quality of life is almost nonexistent because of the daily battle with pain. We're not sure if she will ever be completely healed and since the efficacy of her pain meds seems to be waning, medical marijuana might be her only other option. I would like to bring to your attention, some of the therapeutic benefits that medical marijuana could provide for some of her maladies:
Agency Response: The Agency appreciates and acknowledges these comments, however which strains, delivery methods and products the compassion center decides to produce and sell is a business decision that rests with the compassion center. The compassion center's selection and variety of products will be considered during the RFP process as one of many factors in selecting the winning bid.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process. In addressing the Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
Agency Response: The Agency appreciates and acknowledges these comments, and that recommended change will be made in the finalized regulations.
Agency Response: The Agency appreciates and acknowledges these comments, zoning ordinance decisions are made at the local municipality level. The program will respect the enforcement of local zoning decisions not withstanding section §4917A of the Act.
Agency Response: The Agency appreciates and acknowledges these comments, in accordance with the state's administrative procedures act, the program will use unambiguous language to eliminate confusion or set unacceptable standard.
Agency Response: The Agency appreciates and acknowledges these comments, the program will comb through the draft again to try to locate the DPHH inconsistency.
Agency Response: The Agency appreciates and acknowledges these comments, however the lighting is to prevent shadows and dark spots that would reduce the effectiveness of the security cameras. (7.2.1.2 The outside perimeter of the premises shall be well lighted to enhance the operation of the security cameras.)
Agency Response: The Agency appreciates and acknowledges these comments, the 30 days standard was inspired by the security requirements in Rhode Island Medical Marijuana regulations. The Program adopted several best practices from contemporary programs.
Agency Response: The Agency appreciates and acknowledges these comments, the facility could enact other compensatory security measures such as 24-hour on-site security guard, which would need to be approved by the program. The program did not want to limit the ability to resolve the issue and maintain routine operations.
Agency Response: The Agency appreciates and acknowledges these comments, and yes, caregiver purchases will be documented. However, the tracking of purchases will be based off the patient's card number to ensure the patient does not receive over the authorized allotment in any given period. A caregiver could be purchasing product for several different patients, and in so exceed the threshold of 3 ounces in a 14-day period.
Agency Response: The Agency appreciates and acknowledges these comments, an excellent point which also pointed out another minor administrative error. 7.2.5.6 should be 7.2.5.3 Yes, it would be reasonable to expect more than one individual to conduct the inventory; we will change it to "individual(s)". The Compassion Center is responsible for writing the audit procedures they will follow in the Operations Manual, which will be evaluated in the RFP scoring process. If the procedures are inadequate, the program will direct the Compassion Center to enhance them.
Agency Response: The Agency appreciates and acknowledges these comments, the expectation is seeds will be acquired outside the state and brought into the state for propagation. All plants will start from seeds in the state after the permit is issued on 1 July 2014.
Agency Response: The Agency appreciates and acknowledges these comments; however, the tracking of purchases will be based off the patient's card number to ensure the patient does not receive over the authorized allotment in any given period. A caregiver could be purchasing product for several different patients, and in so exceed the threshold of 3 ounces in a 14-day period.
Agency Response: The Agency appreciates and acknowledges these comments; there is no foreseeable scenario where a patient would receive a plant. The words (or marijuana plants) will be deleted. Tincture and topical creams will be sold by the weight values of the cannabinoid content.
Agency Response: The Agency appreciates and acknowledges these comments. The context of this element is to address the Deputy Attorney General James M. Cole's Memorandum subject Guidance Regarding Marijuana Enforcement. One of the key enforcement priorities is "Preventing the diversion of marijuana from states where it is legal under state law in some form to other states." Additionally, this language is consistent with New Jersey and Rhode Island regulations.
Agency Response: The Agency appreciates and acknowledges these comments. In the course of these regulations, there are various levels of responsibility, from the program level or Office of Medical Marijuana Program (OMMP), the Director of Public Health (DPH or Division) and the authority of the Cabinet Secretary (DHSS or Department). The regulations attempt to acknowledge the appropriate level of authority for the action or task described.
Agency Response: The Agency appreciates and acknowledges these comments. Employees and Compassion Center board members will submit program application with the same documentation as required for a Caregiver.
Agency Response: The Agency appreciates and acknowledges these comments. There should be only one (1) payable party, the program "Division of Public Health, Medical Marijuana Program" who would receive the payment for the issue of ID Cards for Patients, Caregivers and Compassion Center Agents. The regulations will be updated to change the payee to "Division of Public Health, Medical Marijuana Program" throughout the regulation.
Agency Response: The Agency appreciates and acknowledges these comments. Thank you, that change will be made.
Agency Response: The Agency appreciates and acknowledges these comments; however, as a Caregiver is a supportive position by nature and may assist up to five (5) patients, the program will continue to focus on the qualifying patients over caregivers.
Agency Response: The Agency appreciates and acknowledges these comments. Thank you, that change will be made.
Agency Response: The Agency appreciates and acknowledges these comments. There should be only one (1) payable party, the program "Division of Public Health, Medical Marijuana Program" who would receive the payment for the issue of ID Cards for Patients, Caregivers and Compassion Center Agents. The regulations will be update to change the payee to "Division of Public Health, Medical Marijuana Program" throughout the regulation.
Agency Response: The Agency appreciates and acknowledges these comments. No, not in these regulations, but the issue is covered in 16 Del. C. § 4905 A.
Agency Response: The Agency appreciates and acknowledges these comments. This particular issue deals with hearings and the various levels of responsibilities in that process. Some of the tasks are at the Office of the DHSS Secretary (Department) and some of the tasks are handled by the Division of Public Health Director, (Division).
Agency Response: The Agency appreciates and acknowledges these comments. The Hearing Officer will prepare the written decision including recommended action and send it to the Cabinet Secretary (Department) within 30 days of the completion of the hearing. That change will be made to Chapter 7.10.4.1
Agency Response: The Agency appreciates and acknowledges these comments. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process.
Agency Response: The Agency appreciates and acknowledges these comments. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process.
Agency Response: The Agency appreciates and acknowledges these comments. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process. In addressing Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process. In addressing Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process. In addressing Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana. Considering the narrow scope of the pilot compassion center concept, opening an independent testing center would not be a financially viable option at this point. The limited volume of testing would not be enough to sustain the lab and could jeopardize the program. The program will increase the physical inspection of the Compassion Center growing process and pest control. Currently, the use of any pesticide on medical marijuana is prohibited. The issue of pesticide use on medical marijuana is under further study and has been referred to the Delaware Governor's Panel on Pesticide Use. When the Panel issues a recommendation, the regulations will reflect their opinion. Which strains, delivery methods and products the compassion center decides to produce is a business decision that rests with the compassion center. The compassion center's selection and variety of products will be considered during the RFP process as one of many factors in selecting the winning bid.
1. Move forward with issuing registrations to three compassion centers (one in each county) as mandated by Delaware's medical marijuana law and as long as qualified applicants exist.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand.
2. Remove the possession limitation placed on compassion centers for the number of marijuana plants (no more than 150 plants) and usable marijuana (no more than 1,500 ounces).
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
3. Develop and implement regulations for independent test facility centers.
Agency Response: The Agency appreciates and acknowledges these comments. Considering the narrow scope of the pilot compassion center concept, opening an independent testing center would not be a financially viable option at this point. The limited volume of testing would not be enough to sustain the lab and could jeopardize the program. The program will increase the physical inspection of the Compassion Center growing process and pest control.
4. Remove the prohibition of using pesticides within the compassion centers. Require centers to grow marijuana without the use of prohibited pesticides.
Agency Response: The Agency appreciates and acknowledges these comments. Currently, the use of any pesticide on medical marijuana is prohibited. The issue of pesticide use on medical marijuana is under further study and has been referred to the Delaware Governor's Panel on Pesticide Use. When the Panel issues a recommendation, the regulations will reflect their opinion.
Agency Response: The Agency appreciates and acknowledges these comments. Which strains, delivery methods and products the compassion center decides to produce is a business decision that rests with the compassion center. The compassion center's selection and variety of products will be considered during the RFP process as one of many factors in selecting the winning bid.
6. Ensure diversity of methods that the marijuana can be dispensed based on patient recommendation and demand.
Agency Response: The Agency appreciates and acknowledges these comments. The regulations allow the compassion center to create tincture, oils and creams for dispensing. The variety of products will be considered during the RFP process. The production and sale of these items are a business decision that will be made by the compassion centers.
Agency Response: The Agency appreciates and acknowledges these comments. Pricing of products the compassion center decides to sell is a business decision that rests with the compassion center. The compassion center's ability to provide a variety of products at reasonable prices for Medicaid patients will be considered during the RFP process as one of many factors in selecting the winning bid.
8. Remove the minimum age restriction (currently must be at least 18) to apply for medical marijuana in Delaware.
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, specifically its top concern of preventing distribution of marijuana to minors, no one under the age of 18 is authorized to use or possess medical marijuana. The minimum age requirement (age 18) is found within the Act, Title 16 Chapter 49A Section 4909A Paragraph (b).
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office has limited the scope of the program to one (1) compassion center, operating as a pilot program to gauge demand. The State of Delaware is issuing a Request For Proposal (RFP) for the operation of the Compassion Center. The location of the Compassion Center is one of many factors evaluated in the RFP process. The exact location of the Compassion Center will not be known until the completion of the RFP process.
DCCI comment or question: Can any of this information be obtained through FOIA through the state of Delaware or its Agency, if so we request that the language be changed to protect this information as some or all could be proprietary and compromising to the Compassion Center from competitors?
Agency Response: The Agency appreciates and acknowledges these comments. Pursuant to Title 16 Chapter, 49A Section 4920A information is not subject to FOIA.
7.2.6 Maximum amount of compassion center inventory. A registered compassion center:
DCCI comment or question: These caps will greatly restrict the ability to provide the medicine needed to the patient population resulting in patients being forced to seek their medicine from illegal sources which would be unregulated. Their other option would be to just have to suffer without it. These numbers seem to be arbitrary and selected to avoid any federal attention as opposed to a good estimate based on preliminary research of potential patient populations. A limit of inventory like this would put the compassion center in jeopardy of not being able to meet its operational needs to provide the needed medicine for the patients of Delaware. We would recommend an increase in these numbers or an allowance to
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
7.2.6.3 may not purchase usable marijuana or mature marijuana plants from any person other than another registered compassion center.
DCCI comment or question: Since there isn't another registered compassion center in Delaware, can this be obtained from another registered compassion center out of state, such as New Jersey, if not, what compassion center are you referring to?
Agency Response: The Agency appreciates and acknowledges these comments.
7.5.2.1 In response to the requirements of this rule, and upon the approval of the submitted application, the Department shall issue a registry photo identification card to each principal officer, board member, agent, volunteer or employee of a compassion center who is associated with the compassion center and meets the requirements under these regulations. In order for a registry identification card to be obtained, the following items shall be submitted to the medical marijuana program.
DCCI comment or question: since it states show their Delaware drivers license or other identification verifying Delaware residence, are you restricting the compassion centers to only allow them to hire Delaware residents?
Agency Response: The Agency appreciates and acknowledges these comments. Compassion Center agents and employees or other individuals requiring access to restricted areas of a compassion center must be in possession of valid Medical Marijuana program office issued employee card. Requirements to receive an employee card include a valid State of Delaware issued identification and Delaware residence.
Problem: The definition for "compassion center agent" states that a person may not become a compassion center agent if they have been "convicted of an excluded felony offense," or 'convicted of a drug misdemeanor within five years." Later, subpart (b)(2) of the definition for "excluded felony offense" allows for an exception if:
Solution: Delete the misdemeanor conviction disqualification. It seems impractical to exclude individuals with misdemeanor drug offenses whose conduct would not likely have resulted in a conviction under the Act. However, if such a requirement is deemed necessary, misdemeanor conduct should qualify for the same exemption as found in subpart (b)(2) of the definition for "excluded felony offense."
Agency Response: The Agency appreciates and acknowledges these comments. The definition of an excluded offense or misdemeanor is not under review as it pertains to these regulations. The definition of an "excluded felony offense" is found within the Act, Title 16 Chapter 49A Section 4902A Paragraph (7).
Problem: By defining Post-Traumatic Stress Disorder (PTSD), it has become significantly more restrictive than any of the other debilitating medical conditions permitted by the Act. The basis for this additional level of scrutiny seems to be needlessly burdensome for both patients and physicians, as no other condition faces this definition. In fact, based upon the construction of the proposed language, a patient must suffer from all of the included symptoms in order to have a legally sufficient PTSD diagnosis ("including symptoms of intense physical reactions such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating," emphasis added). This seems like a particularly steep hurdle. In order for their be a clinical diagnosis of PTSD, a physician would be utilizing the DSM-5, which already contains criteria to be met with four symptom clusters and three additional criteria related duration of symptoms, functionality, and symptoms not being attributed to a substance or co-occurring medical condition.1
Solution: Delete the definition and do not included heightened requirements for a for PTSD as a qualifying condition. If DHHS finds it necessary to define the term, ASA suggests revising the definition to the following:
1DSM-5 Criteria for PTSD, US Dept. of Veterans Affairs, available at http://www.ptsd.va.gov/professional/pages/dsm5_criteria_ptsd.asp, (last accessed October 30, 2013).
Agency Response: The Agency appreciates and acknowledges these comments. The definition of PTSD was amplified in the regulations to indicate what symptoms are considered debilitating.
2D.C. Code § 7-1671.02(e).
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the Delaware Medical Marijuana Office requires all participants are 18 years or older. Caregivers must be 21 years or older to be qualified.
322 MRSA 2428, sub- 9, G.
Agency Response: The Agency appreciates and acknowledges these comments. Currently, the use of any pesticide on medical marijuana is prohibited. The issue of pesticide use on medical marijuana is under further study and has been referred to the Delaware Governor's Panel on Pesticide Use. When the Panel issues a recommendation, the regulations will reflect their opinion.
Worse still, this approach has been attempted by other states with less than desirable results. New Mexico sought to limit the number of plants that could be grown by cultivation facilities to 95 plants at the state's licensed cultivation facilities. The outcome was numerous shortages of medicine, which was harmful to wellness of New Mexico's patients.4 While the District of Columbia has a similar provision, the only reason why there has not been a shortage of medicine in the District is due to the burdens the District Department of Health has imposed on physicians and patients in order to obtain a physician recommendation and registration identification card. As of October 21, 2013, there were only 59 patients registered in the District's program, meaning that fewer than 0.4% of the District's 15,000 HIV positive population are currently in the program. Therefore, DHHS should not look to the cultivation limits of the D.C. program as a basis for how to appropriately serve the needs of Delaware patients.
4New Mexico experiences pot shortage under tight medical marijuana rules, Associated Press, July 10, 2010, available at http://www.foxnews.com/us/2010/07/16/new-mexico-experiences-potshortage-tight-medical-marijuana-rules/ (last accessed October 30, 2013).
Agency Response: The Agency appreciates and acknowledges these comments. To address Federal Justice Department concerns, the center will be limited to cultivate up to 150 marijuana plants irrespective of stages of growth, and maintain an inventory of no more than 1,500 ounces of useable marijuana.
Agency Response: The Agency appreciates and acknowledges these comments. In an effort to prevent diversion and patient protection, through proper identification of the product, Medical Marijuana should be stored in the container it was purchased, when not being prepared for ingestion or being ingested.
Agency Response: The Agency appreciates and acknowledges these comments.….
Agency Response: The Agency appreciates and acknowledges these comments. A Compassion Center must grow product inventory in accordance with these regulations. The only exception to that premise is when more than one compassion center is operational in Delaware, a compassion center may purchase inventory from another compassion center within Delaware.
Agency Response: The Agency appreciates and acknowledges these comments. The State of Delaware is issuing a Request for Proposal (RFP) for the operation of the Compassion Center. After reviewing the wide variety of aspects covered under the RFP, one bidder will be selected and permitted to open the compassion center. The permit to operate will expire in 24 months; the compassion center operator will receive non-competitive subsequent operating permits after demonstrating consistent compliance with 16 DE Admin. Code 4470 regulations and receipt of the required application including permit fee by the Medical Marijuana Office
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Medical Marijuana Code regulations are adopted and shall become effective January 11, 2014, after publication of the final regulation in the Delaware Register of Regulations.
The Secretary of Delaware Health and Social Services adopts these Regulations in response to the authority vested in the Secretary by 16 Delaware Code Del.C. Chapter Ch. 49A, The Delaware Health and Social Services Medical Marijuana Act. These Regulations establish the standards for the procedures for issuing a certificate of registration to qualified patients and primary caregivers. These Regulations provide a system of permitting and inspection, as well as governing confidentiality, payments of fees, and enforcement of these rules.
Act” means the Delaware Marijuana Act, 16 Del.C. §§4901A et seq.
Adulterated means made impure or inferior by adding extraneous ingredients. Goods that are prepared in food establishments that are licensed facilities in response to 16 Del.C. §122(3)(u) and 16 Del.C. §134, and that contain marijuana for medical use by a registered patient, are not considered to be adulterated.
Advisory board means a nine member committee established, chaired, and appointed by the General Assembly of Delaware to evaluate and make recommendations to the state legislature and the Department.
Applicant” means any person applying to participate in the Delaware Office of Medical Marijuana Program, hereinafter OMMP.
Cardholder means a registered patient or a registered designated caregiver who has been issued and possesses a valid registry identification card.
Compassion center agent” means a principal officer, board member, employee, or agent of a registered compassion center who is 21 years of age or older and has not been convicted of an excluded felony offense, and has not been convicted of a drug misdemeanor within five years.
Debilitating medical condition means one or more of the following:
(a) cancer, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), decompensated cirrhosis (hepatitis C), amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), post-traumatic stress disorder (PTSD), and agitation of Alzheimer’s disease or the treatment of these conditions;
(b) a chronic or debilitating disease, medical condition or symptom listed in these rules and as defined in 16 Del.C. §4902A(3) that qualifies for the medical use of marijuana by a registered patient its treatment that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating pain that has not responded to previously prescribed medication or surgical measures for more than three months or for which other treatment options produced serious side effects; intractable nausea; seizures; or severe and persistent muscle spasms, including but not limited to those characteristic of multiple sclerosis;
(c) any other medical condition or its treatment added by the Department, as provided for in 16 Del.C. §4906A and Section 6.0 of this code..
Department” means the Delaware Department of Health and Social Services.
Designated caregiver means a person who:
Excluded felony offense means:
(a) a violent crime defined in 11 Del.C. §4201(c), that was classified as a felony in the jurisdiction where the person was convicted; or
(2) an offense that consisted of conduct for which this chapter 16 Del.C. Ch. 49A would likely have prevented a conviction, but the conduct either occurred prior to the enactment of this chapter July 1, 2011, or was prosecuted by an authority other than the sState of Delaware.
Incidental amount of marijuanameans marijuana seeds, stalks and roots of the plant that are not included when calculating the allowable amounts of marijuana specified in these rules. This includes the weight of any non-marijuana ingredients combined with marijuana, such as ingredients added to prepare a topical ointment, food or drink.
Marijuana” means the same as defined in 16 Del.C. §4701 (23).
Marijuana paraphernalia is limited to equipment, products and materials that are ordinarily used in planting, propagating, cultivating, growing, harvesting, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, ingesting, inhaling or otherwise introducing marijuana into the human body. It includes:
Medical use means the acquisition, possession, use, delivery, transfer or transportation of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a registered patient’s debilitating medical condition or symptoms associated with the registered patient’s debilitating medical condition.
Onsite assessment means a visit by an employee of the Department for the purpose of ensuring compliance with the requirements of these rules.
Physician means a properly licensed physician subject to 24 Del.C. Chs. 17 and 19, except as otherwise provided in this subsection. If the qualifying patient’s debilitating medical condition is post-traumatic stress disorder, the physician must also be a licensed psychiatrist. In relation to a visiting qualifying patient, “physician” means a person who is licensed with authority to prescribe drugs to humans and who may issue a written certification or its equivalent in the state of the patient’s residence.
Post-Traumatic Stress Disorder” means that a patient meets the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD), per DSM-5 or subsequent current edition, including symptoms of intense physical reactions such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating.
Qualifying patientmeans a person who has been diagnosed by a physician as having a debilitating medical condition.
“Registry identification card means a document issued by the Department that identifies a person as a registered patient or registered designated caregiver.
Tincture” means a mixture created from a concentrated extract of marijuana.
Topical treatment means a mixture or extract of marijuana made into a balm, lotion, ointment or rubbing alcohol solution, that is applied transcutaneously.
Usable amount of medical marijuana for medical use means six ounces or less of usable marijuana as defined below.
Usable marijuana means the dried leaves and flowers of the marijuana plant, and any mixture or preparation of those dried leaves and flowers, including but not limited to tinctures, ointments, and other preparations. It does not include the weight of any non-marijuana ingredients combined with marijuana, such as ingredients added to prepare a topical administration, food, or drink.
Verification system means a phone or web-based system established and maintained by the Department that is available to law enforcement personnel and compassion center agents on a twenty-four-hour basis for verification of registry identification cards.
Visiting qualifying patient means a patient who:
Written certification means a document dated and signed by a physician, stating that in the physician’s opinion the patient is likely to receive therapeutic or palliative benefit from the medical use of marijuana to treat or alleviate the patient’s debilitating medical condition or symptoms associated with the debilitating medical condition. A written certification shall be made only in the course of a bona fide physician-patient relationship where the qualifying patient is under the physician’s care for her or his the qualifying patient’s primary care or for her or his the qualifying patient’s debilitating condition after the physician has completed an assessment of the qualifying patient’s medical history and current medical condition. The bona fide physician-patient relationship may not be limited to authorization for the patient to use medical marijuana or consultation for that purpose. The written certification shall specify the qualifying patient’s debilitating medical condition.
3.1 The Department shall issue a registry identification card to an applicant for the purpose of participating in the medical marijuana program upon the written certification of the applicant’s Pphysician, supporting application documents and a non-refundable application fee with a personal check or a cashier’s check made out to “[State of Delaware Division of Public Health], Medical Marijuana Program.” The following information shall be provided in the participant enrollment form submitted to the Department in order for a registry identification card to be obtained and processed.
3.2.2 the Pphysician’s clinical licensure;
3.2.4 the medical justification for the Pphysician’s certification of the patient’s debilitating medical condition;
3.2.5 the Pphysician’s signature and date;
3.2.9 the length of time the applicant has been under the care of the Pphysician providing the medical provider certification for patient eligibility;
4.2.1.2 Individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. §4902A(7) are prohibited from serving as a designated caregiver. The applicant and qualified patient shall be notified by registered mail of his or her disqualification from being a designated caregiver.
5.1.1.2 contacting the Delaware Division of Professional Regulation to verify that the Pphysician is licensed to practice medicine in Delaware and is in good standing; and
5.1.1.3 contacting the Pphysician to obtain further documentation that the applicant’s medical diagnosis and medical condition qualify the applicant for enrollment in the medical use marijuana program.
7.2.5.[63] Documentation of all inventories conducted in response to Section 7.2.5.1 of these regulations shall include, as a minimum, the date of the inventory, a summary of the inventory findings and the name, signature and title of the [individual individual(s)] who conducted the inventory.
7.2.8.3.1.3 shall not dispense an amount of usable marijuana [or marijuana plants] to a qualifying patient or a qualifying patient’s caregiver that the compassion center principal officer, board member, agent, volunteer or employee knows would cause the recipient to possess more marijuana than is permitted under the Act or these regulations.
7.3.11 a description of the documentation that will accompany a registered compassion center agent when transporting marijuana on behalf of the registered compassion center. In response to 16 Del.C. §4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered compassion center, and a contact number to verify that the marijuana is being transported on behalf of the registered compassion center.
7.5.2.2 In response to 16 Del.C. §§4914A and 4915A, each principal officer, board member, agent, volunteer or employee of a compassion center shall consent to a full nationwide and statewide criminal history screening background check.
7.5.2.2.3 In response to 16 Del.C. §4919A(n), individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. §4902A(7), within five years from the date of application, are prohibited from being a compassion center agent.
7.6.1 a non-refundable application fee, made payable to the Division of Public Health, [State of Delaware Medical Marijuana Program], in the amount of $5,000;
7.6.11 a list of all persons or business entities having 5.0% or more ownership in the compassion center, whether direct or indirect and whether the interest [in is] in profits, land or building, including owners of any business entity which owns all or part of the land or building, and;
7.8.7 the applicant’s plan for making medical marijuana available on [a] an affordable basis to registered qualifying patients enrolled in Medicaid or receiving Supplemental Security Income or Social Security Disability Insurance;
7.9.1 a certification fee, made payable to the Division of Public Health, [State of Delaware Medical Marijuana Program], in the amount of $40,000;
7.10.4.1 A written decision will be issued by the Department within [15 business 30] days of the [completion of the] hearing. The decision will lift the suspension or terminate a registration certificate. The written decision will state with specificity the reasons for the decision.
78.0 Registration and Operation of Testing Facility Centers
78.1 General Requirements for Operation of a Testing Facility Center. RESERVED
78.2 Security Requirements: RESERVED
78.3 Operations Manual. RESERVED
78.4 Required Training. RESERVED
78.5 Personnel Records. RESERVED
78.6 Application for Operation of Testing Facility Center. RESERVED
78.7 Complete Application Required. RESERVED
78.8 Testing Facility Center Application Review Criteria. RESERVED
78.9 Issuance of Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.10 Registry Identification Cards for Principal Officers, Board Members, Agents, Volunteers or Employees of a Testing Facility Center. RESERVED
78.11 Expiration Date. RESERVED
78.12 Expiration, Termination or Renewal of a Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.13 Non-transferable Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.14 Inspection. RESERVED
89.0 Monitoring and Corrective Actions
89.1 On-site Vvisits/Iinterviews
89.1.1 The Department or its designee may perform on-site interviews of a qualified patient or primary caregiver to determine eligibility for the program. The Department may enter the premises of a qualified patient or primary caregiver during business hours for purposes of interviewing a program applicant. Twenty-four (24) hours’ notice will be provided to the qualified patient or primary caregiver prior to an on-site interview.
89.1.2 All qualified patients or primary caregivers shall provide the Department or the Department’s designee immediate access to any material and information necessary for determining eligibility with these requirements.
89.1.3 Failure by the qualified patient or primary caregiver to provide the Department access to the premises or information may result in action up to and including the revocation of the qualified patient or primary caregiver registry identification card and referral to state law enforcement.
89.1.4 Any failure to adhere to these rules, documented by the Department during an interview, may result in sanction(s), including suspension, revocation, non-renewal or denial of licensure and referral to state or local law enforcement.
89.1.5 The Department shall refer credible criminal complaints against a qualified patient or primary a caregiver to the appropriate Delaware state or appropriate local authorities.
89.2 Corrective action:
89.2.1 If violations of these requirements are cited as a result of monitoring, the qualified patient or primary caregiver shall be provided with an official written report of the findings following the monitoring visit.
89.2.2 Unless otherwise specified by the Department, the qualified patient or primary caregiver shall correct the violation within 5 calendar days of receipt of the official written report citing the violation(s).
89.2.3 The violation shall not be deemed corrected until the Department verifies in writing after receiving notice of the corrective action that the corrective action is satisfactory.
89.2.4 If the violation has not been corrected, the Department may issue a notice of contemplated action to revoke the qualified patient’s or designated caregiver’s registry identification card.
89.2.5 Suspension of registry identification card without prior hearing: In accordance with the 16 Delaware Code Chapter Del.C., Ch. 49A, if immediate action is required to protect the health and safety of the general public, the Department may suspend the qualified patient or designated caregiver registry identification card without notice.
89.2.5.1 A qualified patient or primary caregiver whose registry identification card has been summarily suspended is entitled to a record review not later than 30 calendar days after the registry identification card was summarily suspended.
89.2.5.2 The record review requested subsequent to a summary suspension shall be conducted by the Department.
89.2.5.3 The Department shall conduct the record review on the summary suspension by reviewing all documents submitted by both card holder and the Department.
89.2.5.4 The sole issue at a record review on a summary suspension is whether the card holder’s registry identification card shall remain suspended pending a final adjudicatory hearing and ruling.
89.2.5.5 A card holder given notice of summary suspension by the division may submit a written request for a record review. To be effective, the written request shall:
89.2.5.5.1 be made within 30 calendar days, as determined by the postmark, from the date of the notice issued by the Department;
89.2.5.5.2 be properly addressed to the medical marijuana program;
89.2.5.5.3 state the applicant’s name, address, and telephone number(s);
89.2.5.5.4 provide a brief narrative rebutting the circumstances of the suspension, and
89.2.5.5.5 additional documentation must be included with the request for a record review.
89.3 Summary Suspension, Revocation and Appeal Process:
89.3.1 Participation in the medical marijuana program by a qualified patient or primary caregiver does not relieve the qualified patient or primary caregiver from:
89.3.1.1 criminal prosecution or civil penalties for activities not authorized in this rule and act;
89.3.1.2 liability for damages or criminal prosecution arising out of the operation of a vehicle while under the influence of marijuana; or
89.3.1.3 criminal prosecution or civil penalty for possession, distribution or transfers of marijuana or use of marijuana:
89.3.1.3.1 in a school bus or public vehicle;
89.3.1.3.2 on school grounds or property;
89.3.1.3.3 in the workplace of the qualified patient's or primary caregiver's employment;
89.3.1.3.4 at a public park, recreation center, youth center or other public place;
89.3.1.3.5 to a person not approved by the Department pursuant to this rule;
89.3.1.3.6 outside Delaware or attempts to obtain or transport marijuana from outside Delaware; or
89.3.1.3.7 that exceeds the allotted amount of usable medical use marijuana.
89.3.2 Revocation of registry identification card: Violation of any provision of this rule may result in either the summary suspension of the qualified patient’s or primary caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or primary caregiver’s registry identification card, and all lawful privileges under the act.
89.3.3 Grounds for revocation or suspension of registry identification card, denial of renewal application for registry identification card. A registry identification card may be revoked or suspended, and a renewal application may be denied for:
89.3.3.1 failure to comply with any provisions of these requirements;
89.3.3.2 failure to allow a monitoring visit by authorized representatives of the Department;
89.3.3.3 the discovery of repeated violations of these requirements during monitoring visits.
89.4 Request for hearing: A qualified patient or primary caregiver whose registry identification card has been summarily suspended, or who has received a notice of contemplated action to suspend or revoke, may request a hearing, in addition to a request for a record review, for the purpose of review of such action. The request for hearing shall be filed within 30 calendar days of the date the action is taken or the notice of contemplated action is received. The request shall include the following:
89.4.1 a statement of the facts relevant to the review of the action;
89.4.2 a statement of the provision of the act and the rules promulgated under the act that are relevant to the review of the action;
89.4.3 a statement of the arguments that the qualified patient/primary caregiver considers relevant to the review of the action; and
89.4.4 any other evidence considered relevant.
89.5 Hearing process:
89.5.1 All formal adjudicatory hearings held in response to these Regulations shall be conducted by a hearing officer duly appointed by the DHSS Secretary.
89.5.2 Except for telephonic hearings, hearings shall be conducted in Dover or, upon written request by an aggrieved person, in the place or area affected.
89.5.3 All hearings held pursuant to this section shall be open to the public.
89.5.4 The hearing shall be recorded on audiotape or other means of sound reproduction, or by a certified court reporter. The decision as to the type of recording shall be at the discretion of the Department.
89.5.5 Any hearing provided for in this rule may be held telephonically, in the interest of a speedy resolution.
89.5.6 The Department shall schedule and hold the hearing as soon as practicable, however; in any event no later than 60 calendar days from the date the Department receives the request for hearing. The hearing officer shall extend the 60 day time period upon motion for good cause shown or the parties shall extend the 60 day time period by mutual agreement. The Department shall issue notice of hearing, not less than 20 days prior to the hearing, which shall include:
89.5.6.1 a statement of the time, place and nature of the hearing;
89.5.6.2 a statement of the legal authority and jurisdiction under which the hearing is to be held;
89.5.6.3 a short and plain statement of the matters of fact and law asserted;
89.5.6.4 notice to any other parties to give prompt notice of issues controverted in fact or law; and
89.5.6.5 all necessary telephone numbers if a telephonic hearing shall be conducted.
89.6 All parties shall be given the opportunity to respond and present evidence and argument on all relevant issues.
89.7 Record of proceeding: The record of the proceeding shall include the following:
89.7.1 all pleadings, motions and intermediate rulings;
89.7.2 evidence received or considered;
89.7.3 a statement of matters officially noticed;
89.7.4 questions and offers of proof, objections and rulings thereon;
89.7.5 proposed findings and conclusions; and
89.7.6 any action recommended by the hearing officer.
89.8 A party may request a transcription of the proceedings. The party requesting the transcript shall bear the cost of transcription.
89.9 Procedures and evidence:
89.9.1 Any party shall be represented by a person licensed to practice law in Delaware or an individual may represent him or herself.
89.9.2 The rules of evidence as applied in the courts do not apply in these proceedings. Any relevant evidence shall be admitted and such evidence shall be sufficient in itself to support a finding if the evidence is reliable, regardless of the existence of any statutory or common law rule that shall make admission of such evidence improper in a civil action. Irrelevant, immaterial or unduly repetitious evidence shall be excluded at a party’s request or on the hearing officer’s own initiative.
89.9.3 Documentary evidence shall be received in evidence in the form of true copies of the original.
89.9.4 Documentary and other physical evidence shall be authenticated or identified by any reasonable means that shows that the matter in question is what the proponent claims it to be.
89.9.5 The experience, technical competence and specialized knowledge of the hearing officer, the Department or the Department’s staff shall be used in the evaluation of evidence.
89.9.6 Evidence on which the hearing officer shall base his or her decision is limited to the following:
89.9.6.1 all evidence, including any records, investigation reports and documents in the Department’s possession of which the Department desires to avail itself as evidence in making a decision that is offered and made a part of the record of the proceeding; and
89.9.6.2 testimony and exhibits introduced by the parties.
89.9.7 The record shall include all briefs, proposed findings and exceptions and shall show the ruling on each finding, exception or conclusion presented.
89.9.8 A party to a hearing shall submit to the hearing officer, and to all other parties to the hearing, all documents to be introduced at the hearing no later than five business days from the scheduled hearing date to insure the hearing officer and other parties receive the documents prior to the hearing.
89.9.9 The Department may choose to:
89.9.9.1 issue subpoenas for witnesses and other sources of evidence, either on the agency’s initiative or at the request of any party; and
89.9.9.2 administer oaths to witnesses; limit unduly repetitive proof, rebuttal and cross-examination.
89.10 Conduct of proceeding: Unless the hearing officer reasonably determines a different procedure is appropriate, the hearing shall be conducted in accordance with the procedures set forth in this rule. The following procedures shall apply:
89.10.1 the Division shall present an opening statement on the merits and the Cardholder shall make a statement of the defense or reserve the statement until presentation of that party’s case;
89.10.2 after the opening statements, if made, the Division shall present its case in chief in support of the Division’s petition;
89.10.3 upon the conclusion of the Division’s case, the Cardholder shall present its case in defense;
89.10.4 upon conclusion of the Cardholder’s case, the Division shall present rebuttal evidence;
89.10.5 after presentation of the evidence by the parties, the Division shall present a closing argument; the Cardholder then shall present its closing argument and the Division shall present a rebuttal argument; and
89.10.6 thereafter, the matter shall be submitted for recommendation by the hearing officer.
89.11 Continuances: The hearing officer shall not grant a continuance except for good cause shown. A motion to continue a hearing shall be made at least 10 calendar days before the hearing date.
89.12 Telephonic hearings:
89.12.1 Any party requesting a telephonic hearing shall do so within 10 business days of the date of the notice. Immediately after the parties agree to conduct the hearing by telephone, notice of the telephonic hearing shall be made to all parties and shall include all necessary telephone numbers.
89.12.2 Any party that has agreed to a telephonic hearing, but subsequently requests an in-person hearing shall do so in writing to the hearing officer no later than 10 calendar days before the scheduled date of the hearing. The decision to grant or deny the request for an in-person hearing shall be at the discretion of the hearing officer for good cause shown. The hearing officer’s decision to grant or deny the hearing shall be issued in writing and shall include the specific reasons for granting or denying the request. Should the hearing officer grant the request, the hearing shall be rescheduled to a time convenient for all parties. Should the hearing officer deny the request, the telephonic hearing shall proceed as scheduled.
89.12.3 The location or locations of the parties during the hearing shall have a speaker telephone and facsimile machine available so that all shall hear the proceedings and documents shall be transmitted between witnesses and the hearing officer.
89.12.4 The Cardholder shall initiate the telephone call. The Division is responsible for ensuring the telephone number to the Division’s location for the telephonic hearing is accurate and the Division representative is available at said telephone number at the time the hearing is to commence. Failure to provide the correct telephone number or failure to be available at the commencement of the hearing shall be treated as a failure to appear and shall subject the petitioner to a default judgment.
89.12.5 The in-person presence of some parties or witnesses at the hearing does not prevent the participation of other parties or witnesses by telephone with prior approval of the hearing officer.
89.13 Recommended action and final decision:
89.13.1 At the request of the hearing officer or upon motion by either party granted by the hearing officer, and before the hearing officer recommends action by the Secretary, the parties shall submit briefs including findings of fact and conclusions of law for consideration by the hearing officer. The hearing officer holds the discretion to request briefs or grant a motion to submit briefs on any point of law deemed appropriate by the hearing officer. Briefs submitted shall include supporting reasons for any findings or legal conclusions and citations to the record and to relevant law. Should the hearing officer request briefs or grant a party’s motion to submit briefs, the hearing shall be continued until the hearing officer has given the briefs sufficient consideration and brings the hearing to a close. The hearing, however, shall be completed no later than 45 calendar days from the date of continuance.
89.13.2 No more than 30 calendar days after completion of the hearing, the hearing officer shall prepare a written decision containing recommendation of action to be taken by the Secretary. The recommendation shall propose to sustain, modify or reverse the initial decision of the Department or the Department’s agent.
89.13.3 The Secretary shall accept, reject or modify the hearing officer’s recommendation no later than 10 calendar days after receipt of the hearing officer’s recommendation. The final decision or order shall be issued in writing and shall include:
89.13.3.1 a brief summary of the evidence,
89.13.3.2 a statement of findings of fact based upon the evidence,
89.13.3.3 conclusions and the reasons thereof, on all material issues of fact, law or discretion involved,
89.13.3.4 any other conclusions required by law of the Department, and
89.13.3.5 a concise statement of the Department’s specific determination or action taken to sustain, modify or reverse the initial decision of the Department or the Department’s agent.
89.13.3.6 Service shall be made by registered or certified mail.
89.13.4 The final decision or order shall be public information and shall become a part of the record.
910.0 Severability
Last Updated: December 31 1969 19:00:00.
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