Minutes Wednesday, July 15, 2015 Approved August 19, 2015 Call to Order The Colorado Board of Health held a public meeting on Wednesday, July 15, 2015, at 4300 Cherry Creek Dr. South, Sabin-Cleere Conference Room, Bldg. A, Denver, CO 80246. The meeting was called to order at 10:01 a.m. Members Present Christopher Stanley, M.D., District 1; Janelle Orsborn, District 2; Jill Hunsaker-Ryan, County Commissioner, District 3, Board Vice President; Tony Cappello, PhD, District 4, Board President; Betty McLain, District 5; Joan Sowinski, District 6; Rick Brown, District 7; Ray Estacio, M.D., AtLarge; Larry Wolk, M.D., MSPH, Executive Director and Chief Medical Officer, CDPHE. Nadeen Ibrahim, At-Large, was excused. Staff Present Deborah Nelson, Board Administrator; Jennifer L. Weaver, First Assistant Attorney General, and; Jamie L. Thornton, Program Assistant. Review of the minutes from the June 17, 2015 board meeting. The board unanimously approved the meeting minutes as written. Public comments for matters not on the agenda The public did not offer any comments. Board comments for matters not on the agenda The board did not offer any comments. Rule-making Hearing Medical Use of Marijuana The board convened a hearing in order to receive public testimony and consider revisions to 5 CCR 1006-2, Medical Use of Marijuana. The board received written testimony in advance of the hearing. Mike VanDyke, Disease Control and Environmental Epidemiology Division and Natalie Riggins, Medical Marijuana Registry Program presented the proposed amendments. The proposed amendments remove unnecessary notary requirements; add post-traumatic stress disorder (PTSD) as a new debilitating medical condition for a period of four year; and, address issues brought to the department’s attention by the Office of Legislative Legal Services after review of regulation changes approved by the Board of Health in September 2014. The proposed changes also include two (2) technical clarifications to correctly identify a paragraph number and correctly reference the State Administrative Procedure Act. Dr. VanDyke stated that on January 27, 2015 the department received a petition to add PTSD to the list of debilitating conditions eligible for treatment with medical marijuana. He discussed the department’s process for reviewing the petition and he stated that on April 10, 2015, the information was presented to the Scientific Advisory Council (SAC). After careful consideration the SAC voted 7-3 to recommend that the department request the Board of Health add PTSD to the list of debilitating conditions. SAC members in support of the petition opined that adding PTSD would increase transparency of actual usage and support the physician-patient relationship. SAC members that did not support adding PTSD were concerned with the lack of scientific evidence that medical marijuana is medically beneficial. Dr. VanDyke identified several stakeholders who received the notice of rulemaking and that both the department and the board received feedback. Dr. VanDyke highlighted the feedback from two (2) SAC members which was included in the rulemaking packet.
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 Dr. Wolk clarified that the SAC informed his decision to recommend to the board that Colorado add PTSD as a debilitating condition. Dr. Wolk responded to questions regarding ethics, the physicianpatient relationship, the process for removing a qualified condition from the registry, and the time frame for research results. Oral Testimony Thirty-three individuals testified in support of adding PTSD to the list of medical conditions treatable with medical marijuana and two individuals testified in opposition. Members of the SAC testify in support and in opposition of adding PTSD. Supporters included military veterans, assault survivors, patient advocates and individuals experienced in the fields of criminal justice and social services. These individuals discussed the dangerous side-effects of the medications commonly prescribed to treat PTSD, including an increased risk of suicide, and stated that medical marijuana is a safe alternative to these prescribed medications. Many testified that Colorado needs to do more to support veterans, crime victims and vulnerable populations. The board received testimony that research on the efficacy of marijuana has been hindered by the federal laws, regulations and protocols, and this has created delays in establishing the medical efficacy of marijuana for treating PTSD. Multiple individuals testified that marijuana has saved their lives and has had a positive impact on their families because they are better able to manage symptoms associated with PTSD. Individuals opposing the addition of PTSD cited the lack of quality scientific evidence proving that marijuana is safe and effective. The board received testimony that marijuana is not an evidencebased treatment within the medical system, that marijuana may exacerbate conditions such as mental illness, and that a Yale University study found significantly worse outcomes in PTSD symptom severity when marijuana was used. Board Deliberations Dr. Cappello stated that he appreciates the need to balance science and humanity; however, he could not vote to approve adding PTSD to the list of qualifying conditions at this time due to the lack of scientific evidence. Dr. Cappello indicated that the compelling testimony reinforces the need to study the efficacy of medical marijuana. Ms. Orsborn stated that she could not support the addition due to the lack of scientific evidence. She expressed concerned with the four year trial period and that this would become a public experiment. Ms. Sowinski remarked that she was persuaded by the testimony presented today and the New Mexico study involving veterans, which indicated that PTSD symptoms were reduced by 75 percent. She added that the Yale study was only an association study and that the study indicated that there was not a takeaway for clinicians. Ms. Sowinski stated that she thinks that there is enough data to merit adding PTSD at this time. Dr. Stanley acknowledged the testimony and compelling anecdotal evidence but he is concerned with the lack of quality randomized control trial studies proving the safety and efficacy for this particular condition. He also pointed out that a synthetic cannabinoid is available as a prescription in the United States. Commissioner Hunsaker-Ryan stated that she thinks that PTSD should be added to the existing list of debilitating conditions. She discussed prescription drug abuse and a study conducted by University of Colorado and Montana that shows a correlation between medical marijuana laws and lower suicide rates. She added that including PTSD to the list of qualifying conditions will provide better access to different strains under the guidance of a physician.
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 Dr. Estacio appreciated the testimony and acknowledged the imperfect Food and Drug Administration processes but as a physician, thinking of patient care and doing no harm, he cannot support adding PTSD to the list of qualifying conditions due to the lack of clinical evidence. Mr. Brown stated that the testimonials provide the board good information but this needs to balance with the science and the science is currently lacking. Ms. McLain voiced a similar concern that the testimony is compelling but the science of how medical marijuana works and how it helps is lacking. Ms. Sowinski reminded the board that the SAC studied this in depth and there was a clear majority to support adding PTSD to the list of debilitating conditions. Vote Motion 1: Moved by Ms. Sowinski, seconded by Commissioner Hunsaker-Ryan to adopt the proposed amendments to 5 CCR 1006-2, Medical Use of Marijuana, along with the specific statutory authority, regulatory analysis and amended Statement of Basis and Purpose (amended to explain that PTSD would be added to the list of debilitating conditions for four year as this allowed additional time for study and data gathering). Motion failed 6-2. Motion 2: Moved by Dr. Stanley, seconded by Dr. Cappello to adopt the proposed amendments to 5 CCR 1006-2, Medical Use of Marijuana with the exception of the proposed change to Regulation 6, paragraph B.2, along with the statement of basis and purpose, specific statutory authority, and regulatory analysis. Motion carries. Reports Emerging Air Quality Issues Will Allison, Air Quality Control Division and Mike Silverstein, Air Quality Control Commission (AQCC) Administrator provided an overview of the department and commission activities and discussed emerging air quality issues. Their discussion focused on ozone and carbon dioxide. As to ozone, Mr. Allison indicated that the standard is 75 parts per billion and though there are active efforts to reduce oxides of nitrogen and volatile organic compound emissions, Colorado will likely need to do more to meet federal standards. The department and the AQCC will develop a plan by the end of 2016 that will get Colorado within the federal standard by 2018. In addition, the Environmental Protection Agency is finalizing new rules to reduce carbon dioxide emissions in an effort to slow down global climate change; Colorado and other states have appealed to EPA to account for the progress already made in reducing carbon emissions when finalizing the rules. The department and the AQCC will be developing a plan to meet the new federal climate change standards. Mr. Allison and Mr. Silverstein responded to questions regarding high altitude, sunlight, the ability to meet the new ozone standards, and the health effects of ozone versus carbon. Mr. Allison indicated that overall Colorado is cleaner today that it was five and ten years ago, and Colorado has already done a lot to get ahead of these upcoming new standards from the EPA. Executive Director Report Dr. Wolk updated the board regarding: changes in process for reporting to the Governor’s Office; fifty-three (53) new Health Services Corps contracts for underserved areas; the expansion to Saturday testing at the department’s lab improving newborn screening timeliness; the new Electronic Death Registration system; the Colorado Central Cancer Registry receiving a designation of excellence from the Center for Disease Control; the department working with its partners to continue the Long-Acting Reversible Contraception program, and; where the department is in the accreditation process.
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 Attorney General’s Report Ms. Weaver stated that there was no update this month. Board Member Reports of Committee Activities Dr. Stanley and Mr. Brown remarked that the Tobacco Review Committee and the Cancer, Cardiovascular Disease and Pulmonary Disease Review Committee will present their funding requests and a committee member appointment later in the day. Commissioner Hunsaker-Ryan remarked that the Public Health Improvement Steering Committee is meeting on July 16, 2015. Administrative Updates Ms. Nelson discussed August meeting logistics and the Health Equity Environmental Justice pilot. Ms. Nelson indicated that while the meeting day will not change, the meeting location for September will likely change due to maintenance occurring in the Sabin-Cleere room. The meeting will remain in the Denver-Metro area. Rule-making Hearing Preparations for a Bioterrorist Event, Pandemic Influenza, or an Outbreak by a Novel and Highly Fatal Infectious Agent or Biological Toxin The board convened a hearing in order to receive public testimony and consider revisions to 6 CCR 1009-5, Preparations for a Bioterrorist Event, Pandemic Influenza, or an Outbreak by a Novel and Highly Fatal Infectious Agent or Biological Toxin. Lyle Moore, Office of Emergency Preparedness and Response, presented the proposed amendments. Mr. Moore highlighted the changes since the request for hearing in May. The department is not recommending changes to Regulation 4 at this time; Regulation 4 will be reviewed an updated in alignment with Emergency Medical Services rules that are being reviewed in 2016. The term, “federally qualified health center” was specified so the rules aligned with other federal and state references. Phrasing was clarified to be consistent throughout the rule. These changes were the result of additional stakeholder feedback, and feedback from the board and the Attorney General’s Office. Mr. Moore responded to board questions regarding security incidents, impact to rural local public health departments, plan submittal requirements, required preparedness exercises, protective clothing and the timeline for delivery of stockpile items. Ms. Askenazi, Tri-County Health Department, testified in support of the proposed amendments saying the stakeholder process included a wide variety of disciplines and was a very thorough process. No written testimony from the public was received and reviewed by the board prior to the hearing. The board unanimously approved the proposed amendments. Motion: Mr. Brown; seconded: Ms. Orsborn. Vital Statistics The board convened a hearing in order to receive public testimony and consider revisions to 5 CCR 1006-1, Vital Statistics. Dana Erpelding, Center for Health Environmental Data, presented the proposed amendments. The proposed changes promote the use of electronic registration of vital events by including language in the regulations to encourage reporting entities (such as hospitals, funeral homes and coroners) to submit vital event data electronically. Ms. Erpelding mentioned that two changes occurred since the request for hearing packet was presented to the board in May. She stated that the rule language now recognizes electronic signatures as suggested by Ms. Ibrahim and the rule language codifies the existing heirloom birth and marriage certificate fees as the statute requires fees are to be established in rule. No oral testimony was received during the hearing. No written testimony from the public was received and reviewed by the board prior to the hearing.
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 The board unanimously approved the proposed amendments. Motion: Dr. Estacio; seconded: Commissioner Hunsaker-Ryan. Funding Recommendation Cancer, Cardiovascular and Pulmonary Disease Grant Program Funding Recommendation Cassidy Smith, Prevention Services Division, presented funding recommendations, on behalf of the Review Committee for the Cancer, Cardiovascular Disease and Pulmonary Disease Grants Program. Ms. Smith requested approval to provide up to $800,000 per fiscal year (total of $2.4 million) to the Kaiser Foundation Health Plan of Colorado to conduct the evaluation of the CCPD and Health Disparities grants programs during FY 2016-18. The board approved the funding recommendation from the Cancer, Cardiovascular Disease and Pulmonary Disease Grant Committee in the amount not to exceed $2.4 million for the Kaiser Foundation Health Plan of Colorado project as identified in the July 15, 2015 funding recommendation memo. The final award amount may be adjusted as the scope of work for the grant is finalized; however, it will not exceed the amount delineated in the funding recommendation memo. Motion: Mr. Cappello; seconded: Dr. Stanley. Request for Rule-making Hearing Epidemic and Communicable Disease Control Lisa Miller, Disease Control and Environmental Epidemiology Division, asked the board to convene a rule-making hearing to consider amendments to 6 CCR 1009-1, Epidemic and Communicable Disease Control. The proposed amendments provide a number of updates, clarifications, and technical changes. Ms. Miller discussed the major changes, which include: reformatting the entire document and combining three existing tables into one table; adding the requirement for clinical and reference laboratories to submit cultures or original clinical material for specific reportable conditions; deleting methicillin-resistant Staphylococcus aureus (MRSA) from the reportable conditions list; adding Ebola and Middle East Respiratory Syndrome Coronavirus to the reportable conditions list; changing Tularemia from the seven-day report category to the 24-hour report category; requiring that acute flaccid meylitis (AFM) be reported within seven days, and; repealing Regulation 10 so it can be adopted by the Executive Director in compliance with state statute. Ms. Miller responded to questions regarding MRSA, Regulation 10, Regulation 2, AFM and reporting by health care facilities participating in public health projects (Appendix B). By unanimous consent, the board scheduled a public rule-making hearing for September 16, 2015 to receive public testimony and consider the proposed amendments to 6 CCR 1009-1, Epidemic and Communicable Disease Control. Dr. Cappello will chair. Funding Recommendation Tobacco Education, Prevention and Cessation Grant Program Funding Recommendation Natalya Verscheure, Prevention Services Division, presented funding recommendations, on behalf of the Tobacco Education, Prevention and Cessation Grant Program Review Committee. Ms. Verscheure requested approval for funds to be awarded to the University of Colorado, Community Epidemiology and Program Evaluation Group (CEPEG) to plan and implement evaluation of the State Tobacco Education and Prevention Partnership (STEPP) grant program. The total funding requested is $800,000 for the first year and $1.3 million annually for year two and three of the three-year grant cycle, totaling $3.4 million for all three years. The board approved the Tobacco Education, Prevention and Cessation Grant Program Review Committee funding recommendation in an amount not to exceed $800,000 for fiscal year 2016 and $1.3 million per fiscal year for fiscal years 2017 and 2018, for the CEPEG project identified in the July 15, 2015 funding recommendation memo. The
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 final award amount may be adjusted as the scope of work for the grant is finalized; however, it will not exceed the amount delineated in the funding recommendation memo. Motion: Dr. Stanley; seconded: Jill Hunsaker-Ryan. Committee Appointments Tobacco Education, Prevention and Cessation Grant Program Review Committee Natalya Verscheure, Tobacco Program Manager, presented the Committee’s appointment recommendation for the board’s consideration. The board unanimously approved the recommendation to appoint Stacey Wall, MS, APRN, CPNP-AC, PC, Director of Advanced Practice, Children’s Hospital Colorado, as a representative of a statewide association representing physicians. Request for Rule-making Hearings Culturally and Linguistically appropriate Hep C Screening Monica Molina, Bob Bongiovanni, and Andres Guerrero, Disease Control and Environmental Epidemiology Division asked the board to convene a rule-making hearing to consider adopting a proposed new rule 6 CCR 1009-11, Culturally and Linguistically appropriate Hepatitis C Screening. The proposed new rule is necessary to comply with SB 14-173. The legislation requires that if a health care provider offers a screening test, the health care provider shall make the offer of a hepatitis C screening to the patient in a linguistically and culturally appropriate manner, as determined by rules promulgated by the department. In order to implement the legislative mandate the department recommends the Board of Health adopt the National Culturally and Linguistically Appropriate Services (CLAS) Standards. These are uniform standards widely known to the public health and health care community. The purpose of the National CLAS Standards is to provide a blueprint for health and health care organizations to implement culturally and linguistically appropriate services that will advance health equity, improve quality, and help eliminate health care disparities. Ms. Molina stated that it took about nine (9) months to develop the proposed rule. She discussed the stakeholder process to date and stated that the department is still collecting feedback. She stated that the majority of stakeholder feedback has been in support of the proposal. She discussed benefits and limitations of the proposed rule. Ms. Molina responded to board question regarding implementation and the stakeholder process. Commissioner Hunsaker-Ryan, Dr. Stanley, Dr. Estacio and Ms. Sowinski communicated their support to improve the patient’s experience. Commissioner Hunsaker-Ryan supported the use of the CLAS standards. Dr. Stanley asked that the department do additional outreach to the Colorado Medical Society, Internal Medicine Society, and county medical societies such as Denver, El Paso, Larimer and any rural medical societies to ensure small practices have the capacity to implement the CLAS standards. If these stakeholders raised concerns, the department was asked to solicit their feedback as to feasible alternatives. To allow more time for the stakeholder process the hearing was set for October rather than September. Mr. Brown recommended reformatting the endnotes and leaving the adopted date blank to assist others in reviewing and participating in the rulemaking process. By unanimous consent, the board scheduled a public rule-making hearing for October 21, 2015 to receive public testimony and consider the proposed new rule 6 CCR 1009-11, Culturally and Linguistically appropriate Hep C Screening. Ms. Orsborn will chair. Newborn Screening and Second Newborn Screening Laura Gillim-Ross, Dan Wright and Erica Wright, Laboratory Services Division, asked the board to convene a rule-making hearing to consider proposed amendments to 5 CCR 1005-4, Newborn
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Minutes Wednesday, July 15, 2015 Approved August 19, 2015 Screening and Second Newborn Screening (NBS). The proposed amendment adds Pompe to the newborn screening panel. Ms. Wright provided an overview of Pompe disease and discussed the justifications for adding it to the first newborn screen. She stated that there has been limited controversy regarding newborn screening for Pompe disease but there is some concern about the financial and programmatic constraints, and identification of patients with pseudodeficiency via newborn screening. Ms. Wright remarked that the department is able to add Pompe to the panel without increasing its fees and that the laboratory plans to utilize tandem mass spectrometry to limit false positives caused by pseudodeficiency. Ms. Wright stated that if the proposed amendment is adopted, Colorado will have one of the most comprehensive newborn screen processes in the country by screening for 31 out of the 32 recommended disorders. The board asked questions regarding incidents, test cost, treatment and follow-up care and costs, life span, identification and incidence in comparison to conditions currently screened. By unanimous consent, the board scheduled a public rule-making hearing for September 16, 2015 to receive public testimony and consider the proposed new rule 5 CCR 1005-4, Newborn Screening and Second Newborn Screening. Commissioner Hunsaker-Ryan will chair. This meeting was adjourned at approximately 2:44 p.m.
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