Call to Order and Roll Call
The Medicaid Oversight and Advisory Committee meeting was held on Wednesday, September 20, 2017, at 10:00 AM, in Room 149 of the Capitol Annex. Representative Kimberly Poore Moser, Chair, called the meeting to order at 10:03 a.m., and the secretary called the roll.
Present were:
Members: Senator Ralph Alvarado, Co-Chair; Representative Kimberly Poore Moser, Co-Chair; Senators Julie Raque Adams, Danny Carroll, Morgan McGarvey, and Stephen Meredith; Representatives Robert Benvenuti III, Jim Gooch Jr., Joni L. Jenkins, and Melinda Gibbons Prunty.
Guests: Van Ingram, Executive Director, Kentucky Office of Drug Control Policy; Gil Liu, MD, Medical Director, Department for Medicaid Services, Cabinet for Health and Family Services; Dave Adkisson, President and CEO, Kentucky Chamber of Commerce; Allen J. Brenzel, MD, MBA, Medical Director, Department for Behavioral Health, Developmental and Intellectual Disabilities, Cabinet for Health and Family Services, and Associate Professor of Psychiatry and Pediatrics, University of Kentucky; Bonnie Hedrick, Ph.D., Program Manager/Liaison, Northern Kentucky Office of Drug Control Policy and St. Elizabeth Healthcare; Jennifer Hancock, President and CEO, Volunteers of America Mid-States, Freedom House; Danielle Mathieu, RN, Clinical Liaison, Baby Steps Program, St. Elizabeth Healthcare; Henrietta Bada, MD, Director, Division of Maternal and Child Health, Department for Public Health, Cabinet for Health and Family Services, and Professor, University of Kentucky; Mark Jorrisch, MD, President, Kentucky Chapter of the American Society of Addiction Medicine; Molly Rutherford, MD, MPH, Bluegrass Family Wellness, Founder, Vice President, Kentucky Academy of Family Physicians, Past President, Kentucky Society of Addiction Medicine; Linny Cloyd, Deputy, Quick Response Team Coordinator, Boone County Sheriff’s Office; Scott Breeze, M.Ed., NRP, Fire Chief, Independence Fire District, Kenton County; Christina Weinel, ACTS Volunteer, Alexandria Police Department; Jason Merrick, MSW, CADC, Director of Addiction Services, Kenton County Detention Center; David Hayden, Vice President of Clinical Operations, SelfRefind; William Carter II, CEO, The Infinity Center; Steve Cummings, Pharm.D., Our Lady of Peace; Chris Harlow, Pharm.D., St. Matthew’s Pharmacy; Mike Cox, M.Ed., NCC, LPCC, President, Isaiah House, Inc.; Tim Robinson, Founder & CEO, Addiction Recovery Care; Nancy Hale, President and CEO, Operation UNITE; Steve Hart, Kentucky Board of Pharmacy; Ronald Hatfield, Cellarian Health; Keith Mason; Kay Combs and Johnnie Lovins, Kentucky Office of Rural health; Todd Case, Recovery Works; Gary Riddle, Indivior; Brandon Kelley; Donald R. Douglas, MD, Pain Physician; Mary Lewis, Office of Health Policy, Cabinet for Health and Family Services; John J. Wernert, MD, Sagamore Institute; Chris Harlow, St. Matthews Community Pharmacy; Lana Davenport, MD, Psychiatrist, Addictionologist, Medical Director, The Infinity Center; and Kim Hinkel, SOS for Addictions LLC.
LRC Staff: DeeAnn Wenk, Sarah Kidder, Ben Payne, Jonathan Scott, Gina Rigsby, Becky Lancaster, and Heather Scott.
Minutes
A motion to approve the minutes of the August 16, 2017 meeting was made by Senator Raque Adams, seconded by Senator Alvarado, and approved by voice vote.
OPIOIDS IN KENTUCKY: Awareness, Prevention, and Treatment of Heroin and Opioid Use, Misuse, and Abuse
Overview of the Epidemic and Scope of the Crisis
Representative Addia Wuchner stated that opioid addiction increases the tolerance and individuals take higher doses to stave off withdrawal. An addiction spiral can happen quickly. Addiction destroys and fractures families and individual lives, communities, and futures. It fills court dockets, jails, hospital emergency rooms, NICUs, and morgues. People with addiction are suffering from a chemically inflicted disease that attacks the brain and tortures the body. The single most important lesson is that no one chooses the life of an addict. There is hope and recovery.
Representative Kimberly Moser stated that everything heard about the opiate use disorder is real to many families and communities. It cuts across all demographics and touches everyone. Addiction does not matter where you live, how intelligent you are, or your income. Addiction is a complex issue and there needs to be a continuum of care.
Status and Overall Impact of the Heroin and Opioid Crisis
Status of Heroin and Opioid Crisis
Van Ingram, Executive Director, Kentucky Office of Drug Control Policy, stated that 4 Kentuckians and 140 Americans die daily from a drug overdose that could have been prevented. It took over two and a half decades to get into the problem and, unfortunately, will take longer to recover from the problem. While it looks dire, there is hope. In 2016, 1,404 Kentuckians died of an overdose that was largely driven by the introduction of illicit fentanyl into the illicit drug supply. Just because legislation is enacted, there are still individuals with an opioid disorder and still seeking to prevent the withdrawal and feed the addiction. In the first six months of 2017, fentanyl was present in 53 percent of deaths. Foster care, courts, jails, prisons, hospitals, emergency departments, EMS, and police are all affected by the opioid problem. In 2016, 301 million units of opioids, not counting buprenorphine, were prescribed compared to 371 units in 2011. The whole problem is a result of the overexposure of opioids to the country. Kentucky is working on reducing the overexposure. Prescribers are seeking training to learn about the issue and how they can impact the problem. Protocols for pain management and trauma pain are being promoted across Kentucky. House Bill 333 from the 2017 Regular Session will help with overexposure of opioids often accompanied with a 30- to 40-day prescription for a procedure that needs only two to three days of pain medication. There are plans to make treatment on demand a closer reality than it is today. The amended Medicaid 1115 waiver will increase and improve the quality of substance abuse treatment.
Healthcare Impact
Gil Liu, MD, Medical Director, Department for Medicaid Services, Cabinet for Health and Family Services, stated that according to Kentucky’s most recent budget, including federal dollars, Medicaid consumes one-third of every dollar and covers 1.4 million beneficiaries of Kentucky’s 4.4 million population. Kentucky spends a lower amount on behavioral health compared other peer states. Between 2014 and 2016, Kentucky’s expenses on behavioral health have doubled. During the same period of time, expenses on substance abuse disorder treatment have quadrupled. Community mental health centers have always been a safety net. Substance abuse treatments account for 16 percent of payments for behavioral health services. Behavioral health multi-specialty groups are focusing on substance abuse treatments which account for 48 percent of paid claims. In 2016, $325 million was spent on psychotropic medications, a 76 percent growth since 2013. Kentucky Medicaid providers include mental hospitals, behavioral health service organizations, psychiatric residential treatment facilities, community mental health centers, individual physicians, physicians within a group practice, and behavioral health multi-specialty groups. A major feature of the proposed 1115 Medicaid demonstration project waiver is the compiling of economic stimulus programs, initiatives through community engagement to give job training and great job opportunities to Medicaid beneficiaries, and watching the effects of higher quality health care services along with improving socio-economic status to improve the health of beneficiaries in Kentucky. Kentucky needs to strengthen financial incentives to build and sustain new programs. Kentucky is not waiting on federal agencies to issue clear guidance on quality measures.
Approximately 10,491 Medicaid individuals have been diagnosed with Hepatitis C. The disease is clustered in the southeast portion of Kentucky, and there should be tailored approaches to serve the needs of rural communities that have had long-standing challenges of access to health services, especially specialty care. Hepatitis C is curable, but the treatment is costly. Nationwide, the treatment rate is 10.1 percent compared to Kentucky’s rate of 3.2 percent. There are racial disparities in treatment rates. The mission of the Medicaid program is to have excellent service that is sustainable but also equitable. There is a lack of clear documentation of strong treatment plans. A critical component of a treatment plan is care coordination. There a large numbers of individuals with Hepatitis C that have complicating co-morbidities. There are opportunities to strengthen the approach by engaging more effectively with specialists and primary care providers. Currently, the guidelines for Kentucky’s Medicaid authorization of medical treatment for Hepatitis C are more stringent than national care guidelines.
Employment and Economic Impact
Dave Adkisson, President and CEO, Kentucky Chamber of Commerce, stated that the chamber represents approximately 68,000 employers statewide. The impact of the opioid crisis on Kentucky’s health is staggering and the toll on families is devastating. In Kentucky, the opioid crisis has contributed to a low workforce participation rate. If Kentucky was at the national average, there would be approximately 165,000 more workers impacting Kentucky’s economy than there are currently. Opioid addiction is a significant factor that affects the workforce. Many people actively looking for work cannot pass a drug screening required for employment, and many who do have jobs are exiting the workforce due to untreated or undertreated addictions. Kentucky needs a healthy workforce to grow its economy. Prevention and treatment with the goal of full recovery must be a top priority in Kentucky. Worker’s compensation data show that as the age of an injured worker increases the number of pharmaceutical prescriptions increases and opioids are still widely prescribed. Approximately 40 other states have implemented the use of drug formularies and medical treatment guidelines to reduce costs while safeguarding access to quality care. A 2016 research study by the National Council on Compensation Insurance estimates that if Kentucky adopted such a formulary, drug costs under the worker’s compensation program would be reduced by 10 to 20 percent. The business community has become attuned to the fact that this is not just a medical and person issue but an economic issue affecting businesses and employees across the Commonwealth.
In response to a question by Representative Bentley, Dr. Brenzel stated that between 50 percent and 70 percent of people diagnosed with a substance abuse disorder also have a behavioral health disorder. Dr. Liu stated that based on national estimates, over half of the people with addictions have a complicating behavioral health diagnosis outside the drug issue.
In response to comments by Senator Julian Carroll, Mr. Ingram stated that in August, the Office of Drug Control Policy (ODCP) launched a campaign called “Don’t Let Them Die” with the Kentucky Broadcasters Association to have messages played on across Kentucky on 250 radio stations, 19 television stations, and social media. One goal is to reduce stigma. Trying to apply logic to an addict’s thinking and action will never work. The public needs to be educated on the risks of opioids and opportunities on how to resist these drugs.
Awareness and Prevention
Children and Youth and the Impact of Adverse Childhood Experiences (ACEs)
Allen J. Brenzel, MD, MBA, Medical Director, Department for Behavioral Health, Developmental and Intellectual Disabilities, Cabinet for Health and Family Services, and Associate Professor of Psychiatry and Pediatrics, University of Kentucky, stated that The Adverse Childhood Experiences Study is a research study conducted by the American health maintenance organization Kaiser Permanente and the Centers for Disease Control and Prevention. Participants were recruited to the study between 1995 and 1997 and have been in long-term follow-up for health outcomes. The study is the largest of its kind ever conducted to examine the health and social effects of ACEs through the lifespan. The study included largely middle-class individuals with private health insurance in the western part of the country. Adverse childhood experiences (ACEs) include physical abuse, emotional abuse, sexual abuse, domestic violence against a mother, substance abuse in the home, mental illness in a parent, lost parent due to separation or divorce, and household member in jail. The study showed that the number of ACEs, including the ones related to substance abuse, predict an individual’s overall adult health. To make an impact and break the cycle of addiction, ACEs scores have to be used to determine the likelihood of an individual who will become addicted to opioids and other addictions such as alcohol. Kentucky has a significantly higher prevalence of youth with multiple ACEs. The more ACEs, the likelihood of having or marrying into a family with a substance abuse disorder increases dramatically. Not all individuals who develop an opiate disorder had any ACEs, because the problem of addiction is affecting everyone. Prevention and intervention programs need to be targeted toward youth with ACEs because their risk is higher. Improving access to behavioral health and substance use disorder treatment services will break the addiction cycle.
Core-Life
Bonnie Hedrick, Ph.D., Program Manager/Liaison, Northern Kentucky Office of Drug Control Policy and St. Elizabeth Healthcare, stated that primary prevention will pay off much later in life. St. Elizabeth Healthcare has underwritten a campaign in Northern Kentucky and it will extend into some Kentucky media outlets. Recovery and treatment work and give people hope. Early intervention services of neurological impairment can help prevent unhealthy behaviors and health problems. From conception to death, humans live within an environment that will either nurture or limit their growth and development. Every $1 spent on prevention saves $18 in related medical, justice, social, and other costs. Core-Life is a program of Mental Health America of Northern Kentucky and Southwest Ohio. It is a theory-informed framework for enveloping all the wonderful things schools and youth serving groups are already doing to create a wonderful learning environment for the youth it serves. It was developed for schools, but it has applicability in YMCAs, youth camps, and other settings where youth are gathered for positive youth development. Its focus is on building social and emotional skills through the development of positive character traits. It is available from kindergarten to sixth grades. The program changes the way a school interacts with students and families to address ACEs early in a child’s life. Information can be found at CoreLifeNKY.org.
In response to a question by Representative Marzian, Dr. Brenzel stated that Kentucky will spend 20 percent of the federal Cures Act funds on prevention. It includes naloxone and Narcan rescue. The Sources of Strength program taught in schools identifies children who have risk factors and teaches them about health awareness and the child’s potential. It also aligns them with positive mentors and relationships. The Medicaid benefit for substance use was added in Kentucky in 2014. Ms. Hedrick stated that strategic planning and alignment is very important.
In response to a question by Representative Moser, Dr. Brenzel stated that Core-Life costs a school $8,000 compared to other programs that can cost $80,000. Pilot schools have taken the concept of Core-Life and integrated it across many policies and procedures so it is not just an education program. The results show better behavior in students. When coping skills and resiliency are increased in schools, it contributes to academic growth.
Special Populations Part I: Pregnant/Parenting Women and Infants
Jennifer Hancock, President and CEO, Volunteers of America Mid-States, Freedom House, stated that data-driven results show that Volunteers of America (VOA) can keep families healthy and do it while saving money for Kentucky. Freedom House provides an evidence-based, healing environment that puts moms on a path to recovery. It delivers individualized clinical care and programming delivered by accredited health professionals. More than 150 health babies have been born at Freedom House. Freedom House provides residential treatment for pregnant women and women with young children who have a substance use disorder. The comprehensive program is designed to treat women’s addictions, to break the cycle of addiction in families, to reunite families broken apart by addiction, and to promote the birth of health, drug-free babies. In 2015, approximately 1,500 babies were born with Neonatal Abstinence Syndrome (NAS). The Center for Disease Control and Prevention (CDC) states that every baby born with NAS will cost approximately $93,000. When 10 healthy babies are born at the Freedom House, it saves Kentucky nearly $1 million. Freedom House saves Kentucky by preventing babies from being placed in out-of-home care.
Danielle Mathieu, RN, Nurse Liaison, Baby Steps Program, St. Elizabeth Healthcare, stated that the program provides services to pregnant and parenting mothers that are dealing with a substance use disorder focused on opioids. A community nurse liaison and an RN nurse community health worker work in the program. The program helps moms get into the Women’s Residential Assistance Program (WRAP) in Covington. Parenting classes are provided at the Campbell County and Kenton County detention centers where women receive certificates that can be taken to the judge to show they have finished the program. Services provided include Alcoholic Anonymous meetings, parenting education in homes, treatment and housing assistance, medication assisted treatment (MAT) assistance, and reintegration with families and children. Moms can stay in the program up to two years after delivery. The program is focused around hope. From January to September 2017, 368 referrals were made to the program.
Henrietta Bada, MD, Director, Division of Maternal and Child Health, Department for Public Health, Cabinet for Health and Family Services, and Professor of Pediatrics, University of Kentucky, stated that with the current opioid epidemic, it is no surprise that children are also affected. When an infant is born, the supply of opioid from the placenta ceases and an estimated 60 percent to 90 percent of these infants develop a constellation of signs consistent with withdrawal manifestations; this is referred to as Neonatal Abstinence Syndrome (NAS). The maternal use of opioids maybe due to illegal use, or to prescribed medication assisted treatment for opioid dependence or for treatment of chronic pain. Ninety percent of the mothers of infants with NAS mothers have a history of drug (opioid) use; 77 percent of these women test positive during pregnancy or at delivery, and a similar proportion of their babies also test positive in their urine or meconium. Buprenorphine is positive in 30 percent of drug tests, followed by other opioids such as OxyContin or hydrocodone. Other substances noted in drug testing include marijuana and benzodiazepines. In Kentucky, the mothers of babies with NAS are predominantly white, 54 percent are from rural or semi-rural counties, 48 percent have received no prenatal care or started prenatal care late (after the first trimester), 83 percent are on Medicaid, 80 percent are smokers, and 1 out of 4 of has a diagnosis of Hepatitis C which can be transmitted to the baby. Eighteen percent give birth to low birth weight babies. Thirty-nine percent of mothers are in treatment programs during pregnancy but only about a fourth of the programs do drug testing, 20 percent of programs provide mental health counseling, and 5 percent address parenting. Almost half of these mothers in treatment during pregnancy do not continue treatment after delivery.
In 2015, the incidence of NAS was 24 cases per 1,000 live births, a 25 fold increase since 2001. The incidence of NAS varies from one county to another. In some districts in Eastern Kentucky, the incidence of NAS is three times the state average at 63 cases for every 1,000 live births. A plan of safe care needs to be developed. If infants with NAS survive the first year of life, they are reported to have cognitive and speech impairment, and or behavior problems. Teachers report attention problems, which actually become worse with time. However, these detrimental outcomes can be mitigated by caretaker involvement and other protective factors, which will offset the effects of many risk factors. Social and psychological support in addition to providing resources for tangible needs is necessary for mother and child, or the caretaker and the child, if we are to offset the risks for poor outcomes, especially those resulting from adverse childhood experiences.
The plan should also include promoting attachment, access to well-child care, immunizations, testing for perinatal transmission of Hepatitis C, and provide a seamless continuum of care for the caretaker and the child. The plan of safe care should provide a seamless continuum of care for the caretaker-infant dyad with the main goal of promoting optimal long-term child development outcomes.
In response to comments by Representative Wuchner, Ms. Hancock stated that VOA makes long-term investments in working with families. VOA recognizes that addiction is not a disease that has the ability to be placed into remission or recovery in 28 days. VOA recently opened transitional housing to ensure mom has a safe place to live with her family. She remains connected to the program for up to two years.
Ms. Mathieu stated that Baby Steps is more engaged in trying to get the mom into treatment, and it can be a very lengthy and detailed process. The program helps moms 24 hours a day, seven days a week, because problems from the addiction happen at any time. One of the biggest struggles is a mom who says she wants help but then changes her mind. The program follows a mom for two years after delivery.
Dr. Bada stated that the common theme is the need to follow a mom two to three years after delivery.
In response to a question by Senator Raque Adams, Ms. Hancock stated that VOA has raised $3.7 million to purchase and renovate a second facility for 16 additional residential beds as well as intensive inpatient and outpatient programming to integrate care on one campus.
In response to questions by Representative Bentley, Dr. Bada stated that it is difficult to piece out the effect of marijuana on babies with NAS. Studies show that smoking tobacco increases the odds of a baby developing symptoms similar to NAS. Being on other medications adds to the severity of NAS. It is difficult to determine which drugs are causing the baby to respond or not respond to treatment. There are studies that say there is something in some babies’ genes that make the baby more susceptible to treatment versus others who are not. Nurturing needs to be provided to help behavioral problem scores to go down.
Harm Reduction: Safe Drug Disposal
Senator Alice Forgy Kerr stated that 70 percent of all addictions start in a friend’s or family member’s medicine cabinet. Stopping the addiction before it starts is an integral part in solving the addiction crisis. By removing opioid medication from the medicine cabinet, the next addiction can be stopped. Her goal is to provide education, direction, and solutions for safe medication disposal making homes of Kentuckians safe and opioid free.
John Holaday, PhD, CEO, DisposeRx, stated that DisposeRx’s passion is to stop the cycle of addiction and deaths that begin in the medicine cabinet with leftover opioids. One goal was to make a product that is inexpensive, easy, safe, and permanently effective available at a low price to be provided along with a prescription for drugs once dispensed by the pharmacist. Another goal is to provide a combination of education and follow-up. It is hard to change patterns of behavior. There is no controlling organization at the federal level for disposing leftover opioids. The FDA says to flush them or take them back to the pharmacy, the Environmental Protection Agency says not to flush leftover drugs because the pills pollute the land and the water. A simple, safe, and convenient solution put in the vial in which the drug is dispensed is a very good way to tackle the opioid crisis.
Rob Reynolds, Director of Advocacy, Verde Technologies, Inc., stated that Verde is a drug deactivation disposal product. One solution right now is to start to change the paradigm of how the drugs can be managed. The life cycle of a drug needs to be closed. There needs to be a solution on how to dispose of leftover medications at the same time it is dispensed. If parents start disposing of unused medications in a proper way, children will watch and imitate the parents. There is a 96 percent chance someone will use the medication disposal if it is dispensed with the medications.
Senator Kerr stated that her bill would make sure there is something in the hands of the pharmacists that when medications are dispensed there is also a way to dispose of the product safely. She is working with insurance companies, Medicaid, and others to be proactive about the problem.
In response to questions by Senator Alvarado, Senator Kerr stated that private insurers, the Medicaid program, or patients may have to share in the cost. The bill will say that the medication disposal shall be provided at the time a drug is dispensed. Dr. Holaday stated that the DisposeRx product costs $1.50 retail with discounts for larger volumes. Mr. Reynolds stated that Verde has different size products, so the price varies. Senator Kerr stated that there are 8 to 10 other companies that have similar products.
Representative Jenkins stated that Attorney General Andy Beshear has started a pilot project and is distributing 50,000 medication disposal pouches in Floyd, Henderson, McCracken, and Perry counties.
An Opioid Misuse Reduction Strategy
Phillip Chang, MD, Chief Medical Officer, University of Kentucky Healthcare, stated that opioid misuse reduction starts with prevention, treatment, and harm reduction. Approximately 60 percent of drug use starts in someone’s drug cabinet, and 40 percent of those users will end up with a drug problem. Expectations and goals of patients need to be changed. Inform patients that pain will be tolerable but not gone all together. Patients need specialized care plans to cope with pain. There is pain management beyond opioids. Patients need to be educated about side effects and harms of opioids. Inpatient naloxone use has been reduced by half. Doctors, nurses, and future providers need to be educated about awareness of the short-term and long-term harm of opioids, and that there are other options for treating pain. There are non-pharmacologic options such as exercise, art, touch, or music therapy, acupuncture, and massage therapy. There needs to be an arm of surveillance, and that is why he is a huge fan and supporter of KASPER. He is not advocating not prescribing any opioids, but there needs to be a better appreciation of the harm that is caused by addiction to the drugs. Doctors who over prescribe opioids needs to be identified and educated about other options. Efforts need to be coordinated with a multi-model approach to bring experts together to try to combat the problems.
In response to question by Vickie Yates Brown Glisson, Secretary, Cabinet for Health and Family Services, Dr. Chang stated that the language for the Hospital Consumer Assessment of Healthcare Providers and System (HCAHPS), a patient satisfaction survey required by the Centers for Medicare and Medicaid Services (CMS) for all hospitals in the United States for adult inpatients, excluding psychiatric patients, is being changed. The older version asked whether your pain is well controlled, and the newer version asked whether a doctor asked about pain control.
In response to a question by Senator Meredith, Dr. Chang stated that identifying how a physician prescribes is easier said than done. There is no accurate way of knowing exactly who is prescribing and how much. If prescriptions are written on traditional paper pad, it is not catalogued electronically. KASPER allows an individual physician to see what has been prescribed by himself or herself, but there is no way to see how all physicians are prescribing, so there is no comparison. Just because a doctor is prescribing more than another doctor does not mean he or she is a bad doctor because some doctors provide more pain management treatment than others.
In response to Representative Gibbons Prunty, Dr. Chang stated that patients should always have an active role in deciding if they want or need pain medications.
A Physician’s Journey from Addiction to Recovery
Michael Sprintz, MD, Founder and CEO, Sprintz Center for Pain and Recovery, Cellarian Health, stated that he is trained in anesthesia, addiction and pain medicine. He has been in recovery for almost 17 years. His practice specializes in treating patients with chronic pain with or without an addictive disease. During his second year of residency at John Hopkins, he was pulled out and sent to treatment because of his addiction. His use of drugs became more prevalent during medical school. He did not have a drug of choice like most people. Addiction is a neurobiological disorder in the reward center of the brain. An addict does not think logically or rationally. When systems are in place to identify people and help them, wonderful things can happen. John Hopkins had systems in place to identify student doctors who had addiction problems. There is a ritual that goes along with drug use such as shooting up a drug that causes a rush. The mind and body are not separate. Changing a patient’s expectations and experiences as it relates to pain is vital. Decrease in the use of opioids will increase dependence in another area such as alcohol use. Monitoring programs create a structure for an addict. Addiction is a progressive and chronic disease, and there is no simple solution. An abstinence-based model helped him recover. He has founded a company that developed a PDMP enhancement software that works with systems like KASPER that makes it simple and easy for providers to get real-time information about medications a patient is taking so he does not prescribe medications that patient may already be taking. Anxiety and depression worsens pain and pain worsens depression and anxiety. Addicts lie to themselves about their addiction. There is no easy way to tell who has an addiction problem. Pain and addiction are experiences and can be altered in a positive way with things other than opioids. Addiction is not about feeling good, but about not feeling at all. He uses ACEs in his practice to help identify addicts early. The solution is not easy and takes a multidimensional approach. Addicts use more healthcare dollars which hurts the healthcare system.
Pathophysiology of Opioid Use Disorder
Kelly Conrad, PhD, Medical Science Director, Addiction Psychology, Alkermes, stated that opioid use disorder is the term used for excessive opioid use. Patients are diagnosed based on symptoms over the past, using 11 criteria such as frequency of opioid use, inability to control or limit use, presence of cravings, interference with daily life, development of tolerance and presence of withdrawal symptoms in absence of opioids. The term opioids not only includes analgesic drugs like morphine or drugs of abuse like heroin but also natural opioids that are present in the body. The body generates endogenous opioids which are peptide neurotransmitters in the brain and spinal cord. These include the endorphins, enkephalins, and dynorphins. The endogenous opioid systems are involved in the control of pain, of dopamine reward pathway, and of respiration. Opioid drugs act much like the body’s own endogenous opioids, but have a high addiction potential. The term opioid refers to all substances that activate opioid receptors, and which are inhibited by opioid receptor antagonists like naloxone.
Opiate is used to refer to the subset of opioid substances that are structurally very similar to or which are derived from morphine. Opioid analgesic drugs and opioid drugs of abuse all act via one or more types of the opioid receptors in either the pain pathways, reward pathways, or enteric nervous system. The physiological effects of opioids are a result of cellular changes that take place after the opioids bind to the receptors. Opioids have a high addiction potential. One of the primary reasons for this is their effect on the reward pathway. Most drugs of abuse activate the brain’s reward pathway. The strength of efficacy of a drug also depends on the type of drug-receptor interaction. For example, a full agonist such as morphine generally has higher abuse potential than a partial agonist such as buprenorphine. Potency of a drug also determines the abuse liability of a drug. Overlearning of rewards and the cues that predict that reward drive drug addiction and are thought to play a major role in relapse. A reward acts as a teaching signal that promotes future actions that have been experienced as pleasurable and salient. This information leads to a predicted outcome and an action is selected. For example, context and cues such as a syringe or a pill bottle signal the rewards availability and take on an increasing ability to drive drug-seeking behavior.
Three states of the addiction cycle involve different neurological structures or circuits: binge/intoxication, withdrawal/negative mood, and preoccupation/anticipation. Opioid addiction manifests as loss of control over using opioids, despite adverse consequences. Repeated exposure to opioids progressively causes molecular and cellular changes in the neurons. This eventually results in emergency of addiction behaviors. These drug-induced changes promote continued drug use through negative reinforcement. The transition from opioid use to dependence involves a shift from impulsivity to compulsivity. The primary response to binge opioid use is an increase in the levels of dopamine. With repeated use, the primary cellular response to the opioid adapts to neutralize its effect, resulting in a decrease in dopamine levels. This effect may become even more pronounced when the opioid is not available and contributes to the withdrawal response and symptoms.
Prolonged administration of opioids, for analgesia and when abused, leads to tolerance which is characterized by the progressive loss of the opioid’s effect. Higher doses are required to achieve the same effect. When the opioid is stopped, physical withdrawal symptoms occur, while the brain adjusts to operate in the absence of opioids. Opioid use disorder is similar to other chronic illnesses in that it has both physiological and behavioral components. Relapse rates for people with substance use disorders are similar to illnesses such as diabetes, hypertension, and asthma. Thus, opioid use disorder should be treated like any other chronic illness. Relapse does not indicate treatment failure. It can be managed by restarting or changing treatments. Up to 90 percent of individuals with opioid use disorder relapse in the first six months of abstinence without treatment. Several factors can be thought to play a role in predicting the risk of relapse in individual patients such as behavioral predictors and biological predictors. Several factors make it challenging for an opioid use disorder patient to remain abstinent. Sudden cessation of opioid use leads to imbalance in neurotransmitters such as dopamine, glutamate, and noradrenaline.
OPIOIDS IN KENTUCKY: Treatment Options and Recovery Part I
Medication Assisted Treatment (MAT)
Mark Jorrisch, MD, President, Kentucky Chapter of the American Society of Addiction Medicine, stated that the national overdose deaths are exceeding predictions for 2016 by 22 percent, more than 64,000 deaths. The immediate need is for treatment to be available, accessible, and affordable. For opioid use disorder, research supports that medication assisted treatment works best. MAT must be combined with adequate counseling, support, and attention to continued care. Methadone maintenance is highly regulated but it is also time for a review of those regulations. Treatment using buprenorphine has standards in Kentucky that are solid and must be supported. The Kentucky State Chapter of the American Society of Addiction Medicine is ready to collaborate on treatment efforts with the legislature, Kentucky Medical Association (KMA), Kentucky Nurses Association (KNA), Kentucky Board of Medical Licensure (KBML), hospitals, other providers, insurance companies, and pharmacists. Kentucky Medicaid is beginning to address the issue of coverage and compensation for services.
Molly Rutherford, MD, MPH, Bluegrass Family Wellness, Founder, Kentucky Academy of Family Physicians, Vice President, Kentucky Society of Addiction Medicine, Past President, stated that the stigma of opioid use disorder is the main barrier that causes people to not get treatment. To make a difference, she recommended opioid use disorder be recognized as a chronic disease. The physicians who treat the disease should not be judged. The Kentucky Academy of Family Physicians has been holding informative and educational sessions to encourage primary care physicians to learn more about addiction. The right treatment is different for each individual. She stated that people should not strive for perfection but for life and harm reduction. Opioid use disorder is a chronic disease and individuals will relapse. Buprenorphine monoproduct was introduced in France in the mid-1990s, with a 79 percent decline in overdose deaths in six years. It is illegal to prescribe buprenorphine monoproduct in Kentucky unless the patient is pregnant.
Allen J. Brenzel, MD, MBA, Medical Director, Department for Behavioral Health, Developmental and Intellectual Disabilities, Cabinet for Health and Family Services, Associate Professor of Psychiatry and Pediatrics, University of Kentucky testified that there are multiple medications that make up MAT. The three most commonly used medications are methadone, buprenorphine, and naltrexone. Methadone is a full agonist that prevents withdrawal symptoms and reduces craving by activating opioid receptors in the brain. Buprenorphine is a partial agonist that activates and blocks opioid receptors in the brain. Naltrexone is a full antagonist that prevents relapse following complete detoxification from opioids. Porbuphine is an implantable version of buprenorphine. MAT with buprenorphine or methadone requires significant support and monitoring of individuals as they enter recovery and develop the skills to maintain recovery lifestyles.
Dr. Brenzel stated that medication assisted withdrawal provides consecutively smaller doses of a medication such as methadone or buprenorphine as well as non-opioid-agonists to provide a smooth transition from illicit opioid use to a medication-free state. Maintenance pharmacotherapy on an opioid-agonist medication, such as methadone or buprenorphine, is defined as treatment with medication for an indefinite period by fixing and maintaining the level of the opioid in an individual in order to avoid the craving and withdrawal symptoms that abstinence from illicit opioids would produce. There should not be a stigma to long term MAT if that is what the individual requires to lead a healthy lifestyle, to work, and care for family. Methadone is prescribed in narcotic and opioid treatment programs.
Buprenorphine is prescribed in primary care office settings. In Kentucky, there are over 750 physicians that have a Drug Enforcement Administration (DEA) certification to prescribe buprenorphine however, only 80 percent have prescribed for five or less people creating an access issue. Kentucky Medicaid is spending significant resources on buprenorphine. Naltrexone is prescribed in clinical settings including pharmacies. Dr. Expanding timely access to quality treatment providers is a critical strategy in addressing the current opioid use crisis and medication should be coupled with psychosocial treatments and support.
In response to questions from Representative Wuchner, Dr. Rutherford stated that she has seen many individuals go through a five day detox then be sent to figure out the next steps for themselves. It would help the individual to better coordinate care so he or she can stay at the inpatient detox center until transfer to an outpatient program. Dr. Jorrisch stated that the lack of coordination of care is due more to the prior authorization process. For inpatient individuals, it is typically a three to five day process for a prior authorization. In regards to outpatient treatment, there is a prior authorization process for the first prescription. A patient with an opioid use disorder has a damaged brain and may need chronic medication.
In response to questions from Senator Raque Adams, Dr. Rutherford stated that there are problems with the emergency regulation passed in 2014, which made it illegal for physicians who had a Medicaid number to prescribe buprenorphine and bill a patient directly. The regulation drove out several doctors who worked full-time for hospitals but would also work part-time at a facility that prescribed buprenorphine. When the regulation went into effect, doctors could no longer work at the facility part-time because they were violating the law and their prescriptions would not be honored. There are issues with the regulation 201 KAR 9:270, that states that a prescriber cannot use monoproduct in the treatment of addiction unless there is an observed allergy or the patient is pregnant. There is a huge price difference between monoproduct buprenorphine and buprenorphine and naloxone. Prior authorizations are not often approved for 72 hours, which is a long time for a person with an active addiction, the patient could easily relapse.
In response to questions from Senator Alvarado, Dr. Jorrisch stated that employed individuals that are being treated by a physician and taking Suboxone or other kinds of treatment are protected by the American Disabilities Act. A past criminal record is more of a problem in terms of employability.
Dr. Rutherford stated that the buprenorphine depo weekly injection is coming out soon and the porbuphine implant is available. There is a new application that has been approved by the Food and Drug Administration (FDA) to help with cognitive behavior therapy for people with addiction.
In response to questions from Representative Benvenuti, Dr. Rutherford stated that the 100 patient limit, which has gone up to 275 for certain prescribers, cannot be changed by Kentucky because it is a federal regulation. Many physicians do not approach the 100 person limit and more legislation that would limit a physician’s abilities to assist patients in treatment is not needed at this time.
Special Populations Part II: Justice Population
Jail Substance Use Program
Jason Merrick, MSW, CADC, Director of Addiction Services, Kenton County Detention Center, stated that the Kenton County Detention Center has a 125 bed, residential treatment program. The program treats from a bio-psycho social model of treatment and addresses substance abuse as a chronic, progressive, potentially fatal disease. The Kenton County Detention Center is a long-term program. Psychologically, the center’s treatments include cognitive behavioral therapies and socially, the center recognizes that many of its clients are dual diagnosed with anti-social personality disorder. The Kenton County Detention Center participates in the Kentucky Department of Correction’s Substance Abuse Division. Mr. Merrick stated that he is also a person in long-term recovery. Recovery does happen and treatment works.
Angel Initiatives
Christina Weinel, Action Community Training Support (ACTS) Volunteer, Alexandria Police Department, stated that she became a volunteer for the Angel program with the Alexandria Police Department because she lost a son to addiction. The Angel program copies a program from Massachusetts that sends a social worker to follow up on drug related calls made to the police department. The social worker will talk with the family or those with addiction to ask if they want to seek help. In the past ten months, 39 percent of the people that have been reached out to by the Angel program have responded. Thirty-three percent of individuals in the Angel program are in active treatment. Thirty-three percent of individuals have completed the program and 22 percent are not in treatment but remain in contact with volunteers. None of the people are incarcerated. Volunteers reach out to community members in monthly meetings and by holding monthly trainings. Volunteers follow individuals through their recovery and post-recovery process. The program has volunteers who will assist individuals sign up for Medicaid.
Quick Response Teams
Scott Breeze, M.Ed., NRP, Fire Chief, Independence Fire District (IFD), Kenton County, stated that in 2016 there were 56 overdoses. There have been 65 overdoses covered from January 1, 2017 to September 18, 2017. IFD has hired two part-time paramedics and the Kenton County Police Department has hired a part-time officer. Whenever there is an overdose or opioid related call, the IFD will send out a police officer, a paramedic, and a drug addiction counselor to offer assistance to the individual. There have been 10 fatalities out of the 65 overdoses. In overdose incidents, the IFD is seeing significantly more men than women, generally in the ages of 26 to 35. In 2017, the IFD has made 25 direct patient contacts and 27 contacts with patient family members. Naloxone administration is increasing. In 2016, St. Elizabeth Emergency Departments in Covington, Edgewood, Florence, Ft. Thomas, Grant and Owen, treated 1,584 heroin overdoses.
Linny Cloyd, Deputy, Quick Response Team Coordinator, Boone County Sheriff’s Office, stated that years ago, the only course of action to offer assistance was to incarcerate an individual and hope the courts would order or allow treatment. The jail population in Kentucky is at 109 percent. It is necessary to look at other ways to deal with the opioid problem. The Boone County Quick Response Team has been active for three months. The Boone County Quick Response Team will work with people who have been incarcerated for various offenses to offer help and assistance. The response team also works with people with other addictions. The response team will meet with an individual more than one time to offer assistance and to build trust in the community.
Treatment Options and Recovery Part II
Outpatient Treatment
David Hayden, Vice President of Clinical Operations, SelfRefind, stated that SelfRefind is an integrated care approach to addiction treatment. SelfRefind has 15 facilities in Kentucky. The treatment model consists of physician services with the use of buprenorphine products to address the opioid use disorders. SelfRefind requires individual and group counseling. SelfRefind provides case management to reconnect patients to the community. Ninety percent of the patients report improvement in their overall health and 88 percent report improvements in their mental health.
Long-Acting Injections
Steve Cummings, Pharm.D., Our Lady of Peace, stated that the long-acting injection (LAI) clinic is the first retail, pharmacist-operated clinic at a behavioral health care center in the United States. The LAI clinic specializes in dispensing and administration of injectable pharmaceuticals that remain in the patients system from two weeks to three months. The LAI clinic helps to provide to access and compliance to medications necessary for psychosis and addiction. Our Lady of Peace has two detoxification units. Once the patient has agreed to Vivitrol therapy with counseling, the shot can be administered prior to the patient leaving the campus. The hope is that the patient comes to the counseling session sober. The Kentucky Board of Pharmacy allows the pharmacist to inject, not only with vaccinations but with the long-acting injection product lines. The pharmacist can dispense, administer, interpret labs, and bill for services. The LAI clinic at Our Lady of Peace is a financially self-sustainable, reproducible model using only a pharmacist and a medication access coordinator. The medication access coordinator operates to perform the prior authorizations for the provider to help the patient gain accessibility to these products.
Chris Harlow, Pharm.D., CGP, St. Matthews Pharmacy, testified that addiction patients were receiving the first dose of Vivitrol upon discharge from a treatment facility and given a one-time prescription. Patients could not find providers in Louisville willing to administer the extra dose prescribed to them. Dr. Harlow was approached two years ago because he was an independent provider and could provide the new service in his pharmacy. Since that time, Dr. Harlow has partnered with several addiction providers in Louisville and surrounding areas to expand the long-acting injectable program. His program sees patients post-discharge after detoxification. A patient will see a provider and receive a prescription for Vivitrol or the patient is referred by a physician, where there is an established collaborative care agreement. The pharmacy administers a drug screen, conducts a consultation overview of the medication with the clinical pharmacist, administers a test dose of naltrexone tablet authenticated, and administers the medication to the new patient. A patient must be opiate free at the time of administration.
Dr. Harlow stated that a barrier for pharmacists is that they are not recognized as billable providers under Kentucky Medicaid, a fee must be charged to the patient for services provided. Many patients are not able to pay the fee for the program. He is advocating that Medicaid set up a mechanism to reimburse pharmacists as providers. Pharmacists may only administer medications that they dispense. Several payers are blocking pharmacists from billing this medication due to a requirement as a specialty pharmacy. St. Matthews Pharmacy is an accredited specialty pharmacy by the Accreditation Commission for Health Care (ACHC). However, his pharmacy is being blocked because the pharmacy benefit networks (PBNs) have ownership in the specialty pharmacies.
Outpatient Treatment
William Carter II, CEO, The Infinity Center, introduced Lana Davenport, MD, Psychiatrist, Addictionologist, Medical Director, The Infinity Center, to address the committee. Dr. Davenport stated that she has been treating addiction with medication assisted treatment since 2009. She believes a patient cap of 270 is not needed. Patients, as well as the professionals working in the industry, are stigmatized. The Infinity Center has three patients that are involved in the drug court in Boyd County. The patients have been told by the judges they must be taken off Suboxone in order to get their children back. These patients have done very well in the clinic for years and are now faced with the choice of getting their children back or staying in treatment and staying well.
In response to questions from Representative Bentley, Dr. Harlow stated that there is no definition of a true specialty drug and that every PBN treats Vivitrol differently. He stated that he is not aware of a specialty drug course being taught at the University of Kentucky College of Pharmacy. Mr. Hayden stated that 88 percent of patients at SelfRefind come back for follow-up appointments over a six month period. Mr. Carter stated that urine analysis is only clinical way to determine if a patient is taking medication. The Infinity Center drug screens frequently, at random, and provided to the physician every time the patient comes into the office. The Infinity House contracts with laboratory services to provide the lowest possible cost to the patient.
Dr. Davenport stated that in rural Eastern Kentucky, some patients drive up to two hours to get treatment because there are no treatment centers closer to the patient. Many patients do not have access to Narcotics Anonymous or Alcoholics Anonymous meetings in their area. Medication assisted treatment could be a better option because abstinence based treatment depends on having those ancillary support services available locally.
In response to questions from Representative Marzian, Dr. Harlow stated that pharmacists can only bill a patient’s insurance company for the medication. Pharmacists are not recognized as billable providers and cannot bill the insurance company for a dispensing fee. Pharmacists must get reimbursed directly from the patient, if possible. Rehabilitation clinics sometimes call before a patient is discharged to allow his business to call ahead for a prior authorization. The Infinity Center coordinates patient care with Pathways from detoxification to inpatient treatment to intensive outpatient treatment. Mr. Cummings stated that Our Lady of Peace coordinates care with comprehensive care centers as well.
In response to questions from Representative Jenkins, Mr. Hayden stated that there are many areas that have state facilities however, one barrier for a patient achieving sobriety is maintaining housing. It can be difficult in some areas to find a safe place to stay and help from the legislature would be beneficial.
Residential Treatment
Mike Cox, M.Ed., NCC, LPCC, President, Isaiah House, Inc., stated that a residential treatment center is a live-in health care facility providing therapy for substance abuse, mental illness, or other behavioral problems. There are three residential programs at Isaiah House, Inc. The short-term treatment program is a 28 day, Medicaid program that provides comprehensive medical and psychosocial assessments, detoxification monitoring, individualized treatment plan, individual and group counseling, psychoeducational classes, leisure events, and after-care planning. There is also a 100 day program for UNITE clients that in addition to the short-term program provides parenting classes, financial management classes, GED classes, transportation, and the opportunity to begin college courses while on site. Another program is the long-term program that provides eight months of treatment as well as three months of continuum care. Many clients obtain their GED, acquire college credited hours, job skills training, and ongoing medical evaluation.
Mr. Cox stated that in the long-term treatment plan clients maintain sober living housing, receive ongoing counseling, drug testing, and accountability. Clients are given the option after 90 days to obtain full-time employment with benefits. Isaiah House, Inc. is funded by Medicaid, commercial insurance, Operation UNITE, self-pay, donations, grants, and fund raisers. Isaiah House’s mission statement is to provide the best possible care to those entrusted to us regardless of socio-economic means, working not only with the client individually but with the entire family. The Isaiah House faces challenges with funding, insurance companies, and the 16 bed cap in Medicaid.
Tim Robinson, Founder, CEO, Addiction Recovery Care, stated that in 2010 he started Karen’s Place, a recovery center for women, in Louisa, Kentucky. Kentucky is leading the way for solutions to the drug epidemic in the Appalachian states. Addiction Recovery Care takes a holistic approach to care for each individual. Addiction Recovery Care is nationally accredited by the Commission on Accreditation of Rehabilitation Facilities (CARF) Drug and Alcohol Treatment Centers. Addiction Recovery Care has residential, outpatient centers, and a maternity center. Seventy percent of the babies born at the maternity center came back with mother in three days or less.
Mr. Robinson stated that Addiction Recovery Care outpatient programs offer MAT, counseling, case management, and peer support. Every dollar spent on residential drug treatment equals seven dollars in benefits. Benefits are calculated by the decreased costs in medical care, mental health services, criminal activity, and welfare payments, along with the increase in employment earnings. Addiction Recovery Care has a treatment center staff training program that provides a staff internship program, guaranteed jobs, and career paths. Addiction Recovery Care had 16 members graduate the Peer Support Specialist Academy in May of 2017. Addiction Recovery Care has created 200 jobs in eastern Kentucky with an average pay of $37,500 with benefits.
Comprehensive Approaches
Nancy Hale, President, CEO, Operation UNITE, stated that Operation UNITE was launched in 2003 as a comprehensive approach to create long-term success in combating substance abuse. UNITE involves law enforcement, treatment, education, and prevention initiatives. Through collaborative partnerships, more than 100,000 youth have participated in UNITE’s programs, and 4,200 people have entered treatment using a UNITE voucher. UNITE focus is on treatment and education. UNITE staffs a treatment help line to connect people to resources and have supplied $14 million in vouchers for long-term residential drug rehabilitation. The UNITE treatment team responds to approximately 1,200 inquiries a month. Education, with repetitive and consistent messaging, is the key to prevention.
The Progress Made and the Work Ahead
Kentucky Opioid Response Effort (KORE) Grant Initiatives
Allen J. Brenzel, MD, MBA, Medical Director, Department for Behavioral Health, Developmental and Intellectual Disabilities, Cabinet for Health and Family Services, Associate Professor of Psychiatry and Pediatrics, University of Kentucky, stated that the opioid use disorder crisis is complex and multifactorial, there is not one simple answer. Resources include; state substance abuse block grants, state budgeted funds, health care coverage coupled with the Mental Health and Substance Abuse Parity Act, the 1115 Kentucky HEALTH Waiver and the Federal Twenty-First Century CURES Act. Kentucky refers to the Federal Twenty-First Century CURES Act grant as the Kentucky Opioid Response Effort (KORE). KORE prevention will support evidence based, primary prevention programs to be implemented across school age populations. KORE will build on extensive efforts to decrease the inappropriate prescribing of opioids and work on drug disposal efforts.
Dr. Brenzel stated that KORE treatment priorities are to decrease stigma as barrier to treatment and to increase access to high quality, evidence based treatment at all levels. KORE is funding 46 different entities with different state procurement processes and contracts. Treatment programs must allow MAT to receive KORE financial support. The KORE target populations are individuals who have overdosed, are re-entering the community from a correctional setting, pregnant or parenting women, and youth. KORE treatment activities include emergency department peer support contacts, bridge clinics in close proximity to emergency departments, and supported employment for individuals re-entering the community from a correctional setting. KORE will support peer and other recovery support networks and organizations. KORE harm reduction efforts include Narcan distribution and enhancing relationships with syringe access sites to increase likelihood of those individuals getting in to treatment.
Closing Remarks
Representative Kimberly Moser stated that the input presented is very good news for Kentucky. She is looking forward to the outcomes of the implemented programs discussed. She stated that the coordination of care is through education.
Representative Addia Wuchner stated that the opioid topic is complex and multifaceted. She supports a holistic approach for the opioid problem. The long game includes prevention, treatment, recovery, and sober living.
Adjournment
There being no further business, the meeting was adjourned at 3:55 p.m.