Call to Order and Roll Call
Thesixth meeting of the Interim Joint Committee on Health and Welfare was held on Wednesday, November 18, 2015, at 1:00 p.m., in Room 129 of the Capitol Annex. Senator Julie Raque Adams, Co-Chair, called the meeting to order at 1:00 p.m., and the secretary called the roll.
Members:Senator Julie Raque Adams, Co-Chair; Representative Tom Burch, Co-Chair; Senators Ralph Alvarado, Tom Buford, Danny Carroll, David P. Givens, Denise Harper Angel, and Jimmy Higdon; Representatives Robert Benvenuti III, George Brown Jr., Bob M. DeWeese, Reginald Meeks, Tim Moore, Darryl T. Owens, Ruth Ann Palumbo, Russell Webber, and Addia Wuchner.
Guest Legislator: Senator Chris McDaniel.
Guests: R. Stewart Perry, Former National Board Chair, American Diabetes Association; Bob Babbage, Partner, Babbage Cofounder; Connie Gayle White, MD., MS., Facog, Deputy Commissioner, Clinical Affairs, Department for Public Health, Cabinet for Health and Family Services; Gary Daugherty, Director of State Government Affairs, American Diabetes Association; Timothy K. McDaniel, Ph.D., Senior Vice President, Emerging Opportunities, Translational Genomics Research Institute (TGen), Phoenix, Arizona; Thomas Felix, M.D., Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen, Inc.; Amy Dempster, Senior Manager, State Government Affairs, Mid-Atlantic Region, Genentech; Ben Twilley, Senior Manager, State Government Affairs, Express Scripts; Ralph Bouvette, Executive Vice President, American Pharmacy Services Corporation; Robert McFalls, Executive Director, Kentucky Pharmacists Association; Jamie L. Studts, Ph.D., Associate Professor, Department of Behavioral Science, University of Kentucky College of Medicine, and Assistant Director, Cancer Prevention and Control, Markey Cancer Center; Shannon McCracken, Interim Executive Director, Kentucky Associations of Private Providers (KAPP); Connie Calvert and Jonathan Shrewshacy, Board of Optometric Examiners; Richard Heine, Friedell Committee; Jane Cheshire Glibert, Kentucky Teachers’ Retirement System; Bonnie Thorson Young, Seven Counties Services; Nicole S. Biddle, Counsel, Optometrists Board; Todd Trapp and Christa Bell, Cabinet for Health and Family Services, Department for Community Based Services; and Frank Burns, M.D., Kentucky Academy of Eye Physicians and Surgeons
Diabetes Action Plan
R. Stewart Perry, Former National Board Chair, American Diabetes Association, Bob Babbage, Partner, Babbage Cofounder, and Connie Gayle White, MD., MS., Facog, Deputy Commissioner, Clinical Affairs, Department for Public Health, Cabinet for Health and Family Services, stated that 1 in 11 adults in the United States have diabetes. The rate in Kentucky is 1 in 8. In 2013, 11 percent of the members of the Kentucky Employees Health Plan (KEHP) had diabetes. Medicaid members experience a higher rate at 18 percent. In Kentucky’s Appalachian counties, the rate of diabetes among adults is 13.6 percent compared to 9.5 percent for non-Appalachian counties. Kentucky is currently 14th in the nation for diabetes and 8th in pre-diabetes. KRS 211.752 requires an annual Diabetes Action Report (DAP) by the Department for Medicaid Services, Department for Public Health, and the Office of Health Policy within the Cabinet for Health and Family Services and the Department of Employee Insurance with the Personnel Cabinet pertaining to diabetes be submitted to the Legislative Research Commission. In 2013, in-patient hospitalizations for diabetes resulted in charges of $223,507,370 and $33,011,751 for the emergency department visits. Over 69 percent of pregnant women with pre-existing diabetes will deliver by Cesarean section compared to 36 percent of pregnant women without diabetes.
The 16-week lifestyle intervention program, Diabetes Prevention Program (DPP), developed by the Centers for Disease Control and Prevention (CDC) is now a covered service of the KEHP. The goal of the DPP is evidence-based lifestyle changes to prevent type 2 diabetes. The KEHP covers the $429 cost of the DPP for appropriate individuals. Kentucky is currently 10th in the nation for the number of people participating in the National Diabetes Prevention Programs (NDPP). Currently, there are 59 counties with a covered NDPP. Due to earlier diagnosis and improved treatments, the rate of end-stage kidney disease among Kentuckians with diabetes has declined since 2000. The cabinet has received an enhanced CDC grant for work to support expansion of recognized DPPs and recognized Diabetes Self-Management Education (DSME) programs. The DAP legislation helped move the state toward better patient care, data integration, and transparency.
In response to questions by Representative Burch, Mr. Babbage stated that diabetes is found in all economic areas of Kentucky’s population. Dr. White stated that as a person’s education and income increases, the risks of getting diabetes decreases. Mr. Perry stated that before the Medicaid expansion in Kentucky, $1 in every $3 in the Medicaid program was spent on diabetes.
In response to questions by Representative Meeks, Dr. White stated that the KEHP is the only insurance carrier in Kentucky that covers the DPP. Diabetes self -management education classes are offered in some health departments. Gary Daugherty, Director of State Government Affairs, American Diabetes Association, stated that the Medicaid expansion has allowed more individuals to get more adequate healthcare. Representative Meeks asked for a chart that lists DPP participants county by county be provided by the cabinet.
In response to questions by Representative Benvenuti, Dr. White stated that only 59 counties offer DPP programs, so the infrastructure to educate individuals on how to prevent or manage diabetes themselves is not currently available. Diabetes self-management is not offered in every county. Any program is worth it to prevent people from getting diabetes. Mr. Perry stated that currently Medicaid does not cover the DPP.
A motion to approve the October 21, 2015 minutes was made by Representative Burch, seconded by Senator Alvarado, and approved by voice vote.
Timothy K. McDaniel, Ph.D., Senior Vice President, Emerging Opportunities,
Translational Genomics Research Institute (TGen), Phoenix, Arizona, stated that DNA from a cancer patient’s tumor can show the biology of the tumor and be used to identify the right genome-identified drug needed for the treatment of the patient. TGen is a non-profit medical research institute dedicated to translating discoveries in the science of genomics for the benefit of patients. A research team works with a clinical team in order to accelerate any new medical technologies to benefit patients. There are six locations through the state of Arizona, and the disease focus is cancer. TGen also has a clinic to study rare childhood genetic diseases. There is a team that focuses on microbial diseases. Twenty percent of TGen’s budget comes from partnerships with industry companies throughout 28 countries. TGen was created to bring world class researchers to Arizona and raise its global profile and build its economic development by bringing companies to Arizona. Arizona provided $40 million of seed money to TGen over the first five years. The $40 million was matched by private foundation contributions as well as the city of Phoenix. A 2014 report, Promises Economic Benefits, Positive Economic Benefits of TGen on the State of Arizona, reported a $700 million economic impact over the first ten years. In 2014, state tax revenue for TGen and its corporate spinoffs has generated $8.7 million. TGen’s economic impact on Arizona was $22 million in 2006 and $174 million in 2014.
In response to questions by Senator Danny Carroll, Dr. McDaniel stated that TGen has research that spans the range of genetic and childhood developmental disorders.
In response to questions by Senator Alvarado, Dr. McDaniel stated that if a child goes through the full course of diagnostics such as MRIs, spinal taps, muscle biopsies, there would be a 5 percent to 10 percent diagnosis rate. If a genome is applied, the diagnosis is 40 percent. The cause of approximately 12 different genetic diseases have been discovered.
In response to a question by Representative Wuchner, Dr. McDaniel stated that there are 7,000 different rare genetic diseases with only one-half of them that the gene has been identified.
Thomas Felix, M.D., Director, Research and Development Policy, Global Regulatory Affairs and Safety, Amgen, Inc., stated that Amgen is a biotechnology corporation company developing both innovative biologic medicines and biosimilars of non-Amgen products. Amgen’s core business is focused on discovering, developing, and delivering innovative medicines for patients with grievous illness. Biologics are approved for the treatment of cancers, immune system disorders, neurologic disorders, and hematologic conditions. Biologic is a substance that is made from a living organism or its products. Biologics are developed in living systems using complex manufacturing processes involving many highly regulated and unique steps. Biosimilars are versions of existing biologic products which are similar but not identical. The FDA has the discretion to determine that certain studies are not required for generics and biosimilars. Biosimilarity is when a drug is highly similar notwithstanding minor differences in clinically inactive components and has no clinically meaningful differences in safety, purity, and potency of the product. Interchangeability is having the expectation of same clinical result in any given patient and when administered more than once, having no additional risk to safety or efficacy as a result of switching. Biosimilars are not traditional products such as aspirin. The FDA policy on approval standards for biosimilars does not address automatic substitution. Approval of biosimilars was signed into law along with the federal Patient Protection and Affordable Care Act.
Amy Dempster, Senior Manager, State Government Affairs, Mid-Atlantic Region, Genentech, stated that for the past 35 years, Genentech has used human genetic information to discover, develop, manufacture, and commercialize medicines to treat patients with serious, complex, or life-threatening medical conditions including cancer, arthritis, stroke, and cystic fibrosis. Americans of all ages, ethnicities, and income levels are prescribed FDA-approved biologic products manufactured by Genentech. Genentech has headquarters in South San Francisco, California, with the largest warehouse and distribution center located in Louisville, Kentucky. In 2010, the Kentucky Distribution Center in Louisville became Genentech’s primary distribution center of all Genentech and Roche’s products in the United States. Advancing legislation to allow pharmacists to substitute FDA-approved interchangeable biologics is an important step in making sure the residents of Kentucky are given safe and effective medicine that also has additional protections by informing the practitioner of what medicine was actually dispensed to a patient at the pharmacy. Genentech believes it should be up to the prescribing physician or practitioner and the patient to determine the appropriate product used to treat a patient’s illness.
Ben Twilley, Senior Manager, State Government Affairs, Express Scripts, stated that there is a tremendous amount of savings potential for biosimilars. The first biosimilar approved nationally in March 2015 is expected to save the healthcare industry $5.7 billion over the next decade. There are 11 biosimilars that potentially could be approved by the FDA over the next decade that would save $25 billion in savings. Since 2006, biosimilars have been available in Europe that has resulted in a 30 percent discount compared to brand name biologics.
In response to questions by Senator Alvarado, Dr. Felix stated that numerous gaps exist to accurately identify an adverse event and attribute it to the right place. This is not in the best interest of the patients. As a nation we are trying to break down walls in silos of information that exist between members of the healthcare team. There is information that should be shared by a pharmacist and a physician. Information gaps need to be closed that might prevent appropriate continuity of care for a patient if something were to go wrong. Ms. Dempster stated that 20 states and Puerto Rico have enacted laws that require notification to doctors when a drug is substituted with a biosimilar. Mr. Twilley stated that the goal is to have a savings of 30 percent to 40 percent just like Europe experienced. The first biosimilar was approved nationally in 2015 and with a savings of $25 billion to $250 billion.
In response to questions by Senator Higdon, Mr. Twilley stated that a patient receives a prescription and when filling a prescription, a pharmacists makes a substitution, As the pharmacist is processing a claim, a notation is made on the claim that a substitution occurred and then it is automatically updated in the system and updated in the patient’s medical record where the physician is able to retrieve the information. Ms. Dempsey stated that the proposed legislation should state that whatever drug is dispensed to the patient is reported to the physician so a patient’s record can be updated.
Robert McFalls, Executive Director, Kentucky Pharmacists Association, stated that over the years, Kentucky pharmacists have worked with members of the legislature, payors, state agencies, and other organizations to promote prescriber and pharmacy practices to enhance the prescribing and dispensing of generic drugs. Since 1972, Kentucky law requires when a prescription is filled, a generic drug will be dispensed automatically if one is available. On November 13, 2015, the Kentucky Pharmacists Association House of Delegates voted unanimously to oppose any provision in a biologic substitution law that creates an obstacle for the simple and seamless substitution of biologic products deemed interchangeable by the FDA.
Ralph Bouvette, Executive Vice President, American Pharmacy Services Corporation, stated that proposed legislation contains a provision that requires pharmacists to notify the prescriber when a substitution of a biologic products is made with a product deemed interchangeable by the FDA. The legislation has the potential to negatively impact the use of lower cost interchangeable biologics and creates some practical problems for pharmacists and prescribers. In order to determine if a biosimilar can be safely interchanged, the FDA will test the effectiveness of the product; determine that there are no clinically significant differences between the interchangeable product and the original reference product in terms of safety, purity, and potency; and determine that an interchangeable biologic can be administered more than once to an individual and that the risk of switching the patient between the interchangeable product and the original reference product is no greater than the risk of using the original reference product without switching.
The proposed legislation would allow notification to the physician or practitioner to occur by an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefits management system, and a pharmacy record that can be electronically accessed by the physician. Pharmacies without access to these technologies would be required to notify the prescriber by phone, fax, e-mail, or other means. Over time these notifications will overwhelm pharmacists and prescribers’ offices. There is no reason at this time to expect that interchangeable biologics will have any higher incidence of adverse reactions than generic equivalents did when they were first introduced. The better approach would be to make the information available to the prescriber upon request. Pharmacies maintain very detailed records.
In response to questions by Representative Moore, Mr. Bouvette stated that the FDA will have the same screening process in place for biosimilars as it does currently for generics. Mr. McFalls stated that the Department of Insurance is looking into consumer concerns that an individual is required to use a mail order pharmacy after that individual has filled two prescriptions at a local pharmacy. A consumer should know if it is a requirement for mandatory mail order before choosing a health plan. Mr. McFalls did not know when this requirement went into effect, but consumers need to have the choice where to fill a prescription. Representative Moore stated that this requirement would have an impact on small and independent pharmacies.
In response to questions by Senator Alvarado, Mr. McFalls stated that there will be fewer biologic products dispensed compared to regular drug products a daily basis. Senator Alvarado stated that for the patient’s safety, a physician needs to know when a patient has received a shot that does not require a prescription (i.e. flu) and given by someone other than the physician (i.e. Kroger). Mr. Bouvette stated that reporting flu shots has to be specifically stated by protocol that a physician be notified.
In response to questions by Representative Wuchner, Dr. Felix stated that the proposed legislation requires notification to the patient by the pharmacist if there will be a substitution of a prescribed drug with a biosimilar or interchangeable biologic. Mr. Bouvette stated that current generic law states that a substitution is favored and presumed. A sign is posted in all pharmacies that states that if and when an approved generic is available, a patient would receive it unless the doctor or patient states otherwise. Dr. Felix stated that the majority of biologics are administered in a physician’s office. A very small percentage is self-administered by a patient.
In response to a question by Representative Meeks, Dr. Felix stated that no novel therapy has been approved for Alzheimer’s treatment for a long time, but there are a number products in development.
The Kentucky LEADS Collaborative
Jamie L. Studts, Ph.D., Associate Professor, Department of Behavioral Science, University of Kentucky College of Medicine, and Assistant Director, Cancer Prevention and Control, Markey Cancer Center, stated that 30 percent of primary care physicians (PCPs) do not refer a patient diagnosed with lung cancer to medical oncology. Thirty percent of PCPs are not aware of treatment benefits for early and advanced lung cancer. Lung cancer survivors experience lower quality of life, great symptom burden, more distress than other cancer survivors, access fewer survivorship resources, and encounter more barriers to care. The Kentucky LEADS (Lung cancer Education, Awareness, Detection, Survivorship) received a $7 million grant from the Bristol-Myers Squibb Foundation. The Kentucky LEADS Collaborative includes the University of Kentucky’s HealthCare Markey Cancer Center, the University of Louisville’s James Graham Brown Cancer Center, and the Lung Cancer Alliance. There are 15 implementation sites throughout Kentucky. The collaborative engaged primary care providers in interviews regarding their role in lung cancer care. A Lung Cancer Care Task Force was organized that developed the 2015 Lung Cancer in Kentucky: A Primary Care Action Plan. The LEADS Collaborative is dedicated to reducing the burden of lung cancer in Kentucky and beyond through development, evaluation, and discrimination of novel, community-based interventions to promote provider education, survivorship care, and prevention and early detection regarding lung cancer.
Senator Adams stated that lung cancer rates are too high, and she supports a Smoke-free Kentucky.
In response to questions by Senator Danny Carroll, Dr. Studts stated that one of the challenges the Survivorship Care training program is that it is expensive, and there is only enough money to work with 10 implementation sites statewide.
In response to a questions by Representative Burch, Dr. Studts stated that the cost for lung cancer screening is variable, but it is covered under the Affordable Care Act covers because it is United States Preventive Services Task Force Grade B. Technically the cost should be zero, but because it is so new, CMS have not established the rate for reimbursement. Low-dose CT is a CAT scan that delivers a low dose of radiation for a maximum of 15 minutes for entire procedure done on an annual basis to help detect lung cancer at its earliest stage.
Primary Care Providers
Shannon McCracken, Interim Executive Director, Kentucky Associations of Private Providers (KAPP), stated that the KAPP is comprised of 75 agency members from all geographic areas of the Commonwealth. The KAPP supports nearly 80 percent of all SCL waiver recipients and employs over 4,000 full-time employees. The SCL waiver is a Kentucky Medicaid home and community based 1915(c) waiver that provides an alternative to institutional care for individuals with intellectual and developmental disabilities and allows individuals to remain in the community in the least restrictive setting. Currently there are 4,800 participants in the SCL waiver with another 2,000 on a waiting list. Community waivers like the SCL are in line with national trends and also in compliance with the Americans with Disabilities Act of 1990, the Olmstead Act of 1999, and the Home and Community Based Settings Final Rule which Kentucky has to comply with by 2019. The SCL waiver recipients are not patients. The job of providers is to support these individuals as much as possible to live in the community like anyone else. In 2013, the cabinet proposed changes to the SCL waiver with explicit assurance that all participants currently receiving a service under the approved waiver would not lose services. In reality, the amended waiver is full of barriers that hinder the majority of service recipients, especially those with complex needs, and cater to a small subset of the population who are able to function more independently with time-limited supports such as Supported Employment and Community Access. The result has been the recoupment of millions of dollars from providers over the past year, not for waste, fraud, or abuse, but for minor documentation errors for services that were, by all accounts, provided in good faith.
For the amended administration regulation to work, barriers to services and excessive administrative burdens must be removed. Rates have not been changed for 11 years and must be reviewed. Three specific actions that would improve services and give providers some needed relief are to stop or pause the recoupment process in order to review the direction being given to auditors; defer the regulation when it is referred to the Interim Joint Committee on Health and Welfare to examine the public comment process; and require explicit goals of the process be to assess how the system is functioning, ensure that individuals have choices in programs that are appropriately valued and funded, reduce barriers to access, and reduce the regulatory burden.
In response to questions by Representative Burch, Ms. McCracken stated that public comment was submitted opposing the administrative regulation because of the concerns about people losing services. Inspections results can be appealed to the cabinet before a facility is fined. Some agencies never received recoupment of services.
Senator Danny Carroll stated that disconnect between providers and the cabinet needs to change.
Consideration of Referred Administrative Regulations
The following referred administrative regulations were up for consideration: 201 KAR 5:030 – establishes the required hours of study for optometrists and prescribes the approved programs and those records that shall be maintained and submitted showing proof of attendance at these programs; 201 KAR 5:110 – establishes the educational and competence criteria necessary for a therapeutically licensed optometrist to perform expanded therapeutic procedures; 201 KAR 6:070 – establishes the requirements for continuing education and the methods and standards for the accreditation of continuing education courses by the Board of Licensure for Long-Term Care Administrators; 201 KAR 9:305 – establishes the criteria for the continued licensure of athletic trainers; 201 KAR 9:310 – establishes continuing medical education requirements for physicians in Kentucky, including requirements for courses relating to the use of KASPER, pain management, and addiction disorders required for physicians who prescribe or dispense controlled substances in the Commonwealth of Kentucky; 201 KAR 46:010 – establishes definitions for terms used in 201 KAR Chapter 46; 201 KAR 46:020 – establishes fees for the licensure of an advanced imaging professional, a medical imaging technologist, a radiographer, a radiation therapist, a nuclear medicine technologist, and a limited x-ray machine operator; 201 KAR 46:030 – establishes uniform curricula standards for post-secondary education institutions by the Board of Medical Imaging and Radiation Therapy; 201 KAR 46:040 – establishes uniform standards for the licensure of individuals who perform medical imaging and radiation therapy for diagnostic and therapeutic purposes while under the supervision of a licensed practitioner of the healing arts; 201 KAR 46:045 – establishes procedures for the temporary licensure of medical imaging technologists, advanced imaging professionals, and radiation therapists who are eligible to apply for the appropriate national board exam; 201 KAR 46:050 – establishes procedures for the provisional licensure of nuclear medicine technologists and radiation therapists who are seeking post-primary certification in computed tomography (CT) and radiographers or radiation therapists who are seeking post-primary certification in positron emission tomography (PET) to gain clinical competency; 201 KAR 46:060 – delineates the requirements for continuing education and prescribes methods and standards for the approval of continuing education courses by the Board of Medical Imaging and Radiation Therapy; 201 KAR 46:070 – establishes uniform enforcement procedures regarding the licensure of an advanced imaging professional, a medical imaging technologists, a radiographer, a radiation therapist, a nuclear medicine technologist, or a limited x-ray machine operation and penalties for violation of licensure requirements; 201 KAR 46:081 – establishes the requirements for the licensure of a limited x-ray machine operator; 902 KAR 20:320 – provides minimum licensure requirements regarding the operation of and services provided in Level I or Level II psychiatric residential treatment facilities, including those facilities which elect to provide outpatient behavioral health services (deferred before the September and October meetings by CHFS); 921 KAR 2:006 – establishes the technical requirements of school attendance, residence, citizenship, deprivation, living with a relative, age, one (1) category of assistance, cooperation in child supports activities, strikers, minor teenage parent provisions, time limits and potential entitlement for other programs for eligibility for benefits from the Kentucky Transitional Assistance Program (K-TAP); 921 KAR 2:016 – sets forth the standards of need for and the amount of a Kentucky Transitional Assistance Program payment; 921 KAR 2:017 – establishes requirements for receiving Kentucky Works Program (KWP) supportive services; 921 KAR 2:046 – establishes the conditions under which an application is denied or assistance is decreased or discontinued and advance notice requirements; 921 KAR 2:050 – establishes the time and manner of payments for the Kentucky Transitional Assistance Program (K-TAP) and the Kentucky Works Program (KWP) in conformity with the Social Security Act, 42 U.S.C. 601 – 619, and federal regulations; 921 KAR 2:055 – establishes the requirements to be followed in conducting a hearing related to the Kentucky Transitional Assistance Program (K-TAP), the Low-Income Home Energy Assistance Program (LIHEAP), the State Supplementation Program (SSP), or an applicant or a recipient of the Child Care Assistance Program (CCAP); 921 KAR 2:060 – establishes the designation of certain employees by the secretary of the Cabinet for Health and Family Services to administer oaths and affirmations, in conformity with KRS 205.170(1); 921 KAR 2:370 – sets forth the technical requirements of the Kentucky Works Program (KWP); 921 KAR 2:500 – establishes requirements for the Family Alternatives Diversion Program (FAD); 921 KAR 2:510 – establishes eligibility requirements for the Relocation Assistance Program (RAP); 921 KAR 2:520 – establishes requirements for receiving the work incentive payment; 921 KAR 3:035 – establishes the certification process used by the cabinet in the administration of SNAP; 921 KAR 3:042 – establishes technical eligibility requirements used by the cabinet in the administration of the SNAP Employment and Training Program (E&T); 921 KAR 3:050 – establishes the criteria for recipient claims, collections provisions, and additional provisions used by the cabinet in the administration of SNAP; 921 KAR 3:090 & E – establishes requirements for the Simplified Assistance for the Elderly Program (SAFE), a demonstration project administered by the cabinet to improve access to SNAP for elderly and disabled individuals; 922 KAR 1:310 – establishes basic standards for child-placing agencies; 922 KAR 1:340 – establishes basic standards of care for independent living programs; 922 KAR 1:350 – establishes criteria for public agency foster homes, adoptive homes, and respite care providers caring for foster or adoptive children; and 922 KAR 1:495 – establishes minimum training requirements for foster parents, adoptive parents, and respite care providers caring for foster or adoptive children in the custody of the cabinet.
There being no further business the meeting was adjourned at 3:45 p.m.