The 3rd meeting of the Interim Joint Committee on Health and Welfare was held on Tuesday, August 24, 2004, at 2:00 PM, in Louisville at the Brown & Williamson Club, Papa John's Cardinal Stadium. Representative Tom Burch, Co-Chair, called the meeting to order at 2:03 PM, and the secretary called the roll.
Present were:
Members: Senator Julie Denton, Co-Chair; Representative Tom Burch, Co-Chair; Senators Charlie Borders, Tom Buford, David K. Karem, Richard Roeding, Katie Stine, and Johnny Ray Turner; Representatives Robert Damron, Bob DeWeese, Jimmy Higdon, Joni Jenkins, Mary Lou Marzian, Stephen Nunn, Ruth Ann Palumbo, Ancel Smith, Kathy Stein, and Susan Westrom.
Guest Legislator: Representative Jimmie Lee.
Guests: Nathan Goldman, Kentucky Board of Nursing; David Moody, Wyeth Pharmaceuticals; Ken Green, National Seating & Mobility; William D. Hackersaus and Adewale Trautman, Department for Public Health, Cabinet for Health and Family Services; Darla Bailey, Kaleidoscope; Ron Coleman, Schering; Ronald Atlas and Joe Beyer, University of Louisville; Marty White, Kentucky Medical Association; Phil Peters, American Association of Retired Persons; Louis Kurtz, Department for Mental Health and Mental Retardation Services, Cabinet for Health and Family Services; Brenda Jones, Ombudsman's Office, Cabinet for Health and Family Services; Eileen Recktenwald, Kentucky Association of Sexual Assault; Ellen Kelley, National Multiple Sclerosis Society; John Brazel, Kentucky Pharmacists Association; Janita Perry, Louisville Metro Health Department; Rosana Aydt, Kathy Yelton, Teresa Cavanaugh, and Kim Switzer, St. Vincent dePaul Community Pharmacy; Sheila Schuster, Kentucky Mental Health Coalition; Sean M. Cutter, McBrayer, McMillan, Leslie and Kirk; Stacy H. Woodrum, Kentucky Hospice Association; Prentice Harvey, Norton Healthcare; Steve Spalding, President and CEO, Louisville Medical Center Development Corporation; Amy Turner, Legal Aid Society; Mary Gwen Wheeler, Louisville Metro Cabinet for Health and Family Services; Dr. James Ramsey, President of the University of Louisville; Mayor Jerry Abramson; Cedric Francois, CEO, Potentia Pharmaceuticals, Inc.; Jon Klein, M.D., Ph.D., James Graham Brown Chair in Proteomics, Professor of Medicine, Director of Core Proteomics, University of Louisville; Rick Clover, M.D., Dean, School of Public Health and Information Sciences, Associate Vice President for Health Affairs/Health Informatics; Dr. James W. Holsinger, Secretary of the Cabinet for Health and Family Services; and Pat Wear, Commissioner, Department for Mental Health/Mental Retardation Services, Cabinet for Health and Family Services.
LRC Staff: Robert Jenkins, CSA, Barbara Baker, Eric Clark, DeeAnn Mansfield, Gina Rigsby, Cindy Smith, and Murray Wood.
A motion to approve the minutes of the July 8, 2004 meeting was made by Senator Buford, seconded by Representative Nunn, and approved by voice vote.
The next order of business was an overview of the University of Louisville Life Science Initiatives by Dr. James Ramsey, President of the University of Louisville. Dr. Ramsey stated that the Postsecondary Education Improvement Act of 1997 mandated the University to become a preeminent metropolitan research University. The goals of the University are to provide educational excellence and student success, build a research enterprise, be a diverse, open, and accessible campus, collaborate as a community partner, and be good and accountable stewards. He said that the University's research priorities are cancer, hearts, neurosurgery, pediatrics, ophthalmology, the Center for Deterrence of Bioterrorism and Biowarfare, transplantation research, proteomics platforms, and birth defects center.
Dr. Ramsey said that research outcomes are new economic opportunities for technology transfer, licenses and patents, and biotech spin-offs and new treatments for cancer, hearts, surgical recovery, and transplantation. Some education highlights include a Paris Simulation Center, a standardized patient program, and PDAs for every medical and dental student. He said that some outreach highlights include the Trover Clinic in Taylor County, service programs such as Smile!Kentucky, the Center for Bioethics, Health Policy and Law, the Owensboro cancer partnership with Large Scale Biology and Owensboro Hospital, and collaboration with Caldwell County, Warren County, and the Jefferson County Public Schools for the use of computers.
Dr. Ramsey stated that the Cardiovascular Innovation Institute conducts research and development of heart assist devices, builds upon the reputations of Drs. Gray and Dowling, has a partnership with Jewish Hospital and the Commonwealth, receives support from Sen. McConnell and the Kosair charities, has a new facility in the Louisville Medical Center, and will enhance economic development in the biotech arena. The goals of the James Graham Brown Cancer Center are research to improve cancer care and treatment, National Cancer Institute designation, and quality cancer care close to home. The Center has more than 100 leading cancer researchers and clinicians. A biotech spin-off is Aptamera. He said that the Center has raised $41.5 million in a private fund-raising campaign, and the Center has a new research building.
The next order of business was an overview of the Louisville Medical Center Development Corporation (LMCDC) by Mayor Jerry Abramson, Steve Spalding, President and CEO, LMCDC, Cedric Francois, CEO, Potentia Pharmaceuticals, Inc., and Jon Klein, M.D., Ph.D., James Graham Brown Chair in Proteomics, Professor of Medicine, Director of Core Proteomics, University of Louisville. Mayor Abramson stated that approximately 12 years ago there was an idea to create a medical development corporation with participation from all the downtown hospitals and the University medical school. Today there is collaboration between Jewish Hospital, Norton's Healthcare, the University of Louisville's Hospital, and Metro Louisville. The goal is to attract researchers and companies to Louisville to help with research and economic development.
Mr. Spalding stated that the LMCDC was founded by Mayor Abramson and focuses on an integrated academic medical center with collaboration between Jewish Hospital Healthcare Services, Norton Healthcare, the University of Louisville Hospital, the University of Louisville Health Sciences Center, and the Jefferson Community College. The LMCDC coordinates the Louisville Medical Center (LMC) economic development initiatives. LMCDC's vision is to make the Louisville Medical Center the next significant biomedical commercialization center in the United States. He said that the University of Louisville research focus is on cardiovascular disease, oncology, neuroscience, transplantation/cellular therapeutics, human development (aging/pediatrics), bioterrorism deterrence, ophthalmology, and proteomics.
Mr. Spalding said that MedCenter Three was allocated a $5 million state appropriation plus a $5 million Kentucky Innovation Act grant. The MedCenter houses the MetaCyte Business Lab. He stated that MetaCyte's mission is to lead entrepreneurs with concepts and emerging technologies to the resources they need to take their ideas to the marketplace. The LMCDC has real estate investments of $27 million, with 9.5 acres acquired. He said that 230,000 square feet of space was developed, with 204,000 square feet occupied. There have been three early stage companies and 18 start-ups involved. The challenges that lie ahead are (1) to make life science commercialization the primary economic development focus of the region; (2) to align the University's vision with the community's life science commercialization focus; (3) to create significant life science investment capital pool of $25 million to $30 million and link with regional and national funds to access $100 million; (4) to build capacity of commercialization infrastructure between the University of Louisville Office of Technology Development and MetaCyte Business Lab; (5) to focus Bucks for Brains investments on areas of the greatest commercialization potential; (6) to leverage the University's liberal tech transfer policy in recruiting top researchers; (7) to build life science workforce, entrepreneurship base; (8) to continue development of the Research Park to achieve critical mass; (9) to attract and build 30 companies in the next six years; and (10) to expand the base of support among corporate, foundation, and government stakeholders.
Representative Damron asked about an estimate of the amount of indebtedness to make this program work and if the University had bonding authority. Dr. Ramsey stated that the University does need the debt capacity, and has a budget that authorizes the ability to move forward with projects.
Mr. Francois stated that the company was created out of winning the Harvard Business School business plan competition in 2001. At the end of 2003, Potentia had submitted ten grant requests, with four grants being funded. Potentia came to Louisville with a limited amount of funds initially, embedded its own researchers in the University of Louisville, and started sponsoring research. Because of the faculty positions, the University offered access to infrastructure, access to laboratories, scientific and administrative support, and academic credibility. The University offers the opportunity to young investigators to be part of a top university and remain in academia while living an entrepreneurial dream.
Senator Stine asked about directed evolution. Mr. Francois stated it is directing the evolution inside a cell.
Dr. Klein said that proteomics is a systematic analysis of proteins for their identity, quantity, and function. Proteomics provides vital information that the human genome database cannot. He stated that a proteomics training program is needed because proteomics science is complex and scarce resources need to be shared. Proteomics is a key technology for biotech companies, and Kentucky had the first University core proteomics laboratory in the United Sates and the first University-based proteomics training program. He said that the proteomics training program is funded by a grant from the state in 2002, with 32 students in the first 12 months. Graduates of the proteomics training program have had four grants funded, two inventions, and patents filed with one being approved. The goal of clinical proteomics is to discover biomarkers that diagnose disease and can demonstrate the response to new treatments. The application of biomarkers is to determine the extent of a disease, predict outcomes, and screen and diagnose.
Representative Stein asked if the mass spectrometer is used for newborn screening. He said that one like it is used at Kosair. She asked if the University of Louisville and University of Kentucky could cross-use a mass spectrometer. Dr. Klein stated that the University of Louisville has a number of collaborations with the University of Kentucky.
The next order of business was legislative consideration of Executive Order 2004-726, relating to the reorganization of the Cabinet for Health and Family Services by Dr. James W. Holsinger, Secretary of the Cabinet for Health and Family Services. Dr. Holsinger stated an additional executive order was issued to align the divisions within the cabinet. Amy Turner, an attorney for the Legal Aid Society in Louisville, asked Dr. Holsinger if the restructuring of the cabinet would affect the administrative hearings process, and Dr. Holsinger said that it would not. Ms. Turner asked about plans to change the eligibility hearings to full KRS Chapter 13B hearings, and Dr. Holsinger stated that there would have to be a policy change and the reorganization would not force any change in regard to hearings. A motion to accept Executive Order 2004-726 was made by Senator Buford, seconded by Representative Nunn, and accepted by voice vote.
The next order of business was an overview of the bioterrorism initiatives at the University of Louisville by Rick Clover, M.D., Dean of the School of Public Health and Information Sciences, Associate Vice President for Health Affairs/Health Informatics. Dr. Clover stated the Louisville and Jefferson County Crisis Group is composed of leaders from public safety, emergency management, law enforcement agencies, fire departments, public health, and the University of Louisville. The medical task force is led by Dr. Bill Smock. He stated that the Center for the Deterrence of Biowarfare and Bioterrorism's goals are to develop educational programs for the University of Louisville, the region, an the state that will highlight: (1) potential agents used in biowarfare; (2) clinical syndromes associated with these agents; (3) laboratory investigation; (4) coordination with public health and law enforcement agencies; (5) strategies for large-scale immunization and treatment; (6) psychological and social responses; and (7) ethical and legal issues.
Dr. Clover said that the University of Louisville receives a multi-year grant from the Centers for Disease Control and Prevention to develop and implement instructional models into the medical curriculum. Instruction is provided to students, faculty, health care providers in more than ten states, Louisville community health care providers, and the public. The Center plays a key role in education by teaching and assessment throughout the entire educational program, instant feedback and remediation, advanced training and assessment residencies, continuing medical, dental, and nursing education, disaster preparedness, small group learning, and interactive self-directed learning. He said the Center has trained at least one health care worker/first responder from every county in Kentucky. The Center collaborates with the Louisville Metro Health Department and government, the Kentucky Department for Public Health, the Kentucky CPE Public Health Consortium, the University of Kentucky Research Initiatives, and community organizations and agencies.
The next order of business was a legislative public hearing on the FY 2005 Community Mental Health Services Block Grant by Pat Wear, Commissioner of the Department for Mental Health/Mental Retardation Services, Karen Haskel, Division Administrator for Mental Health and Substance Abuse, and Lou Kurtz, Cabinet for Health and Family Services. Mr. Wear stated the cabinet has received the block grant since 1989 and represents approximately $5,700,000 of the mental health funding. The money is provided to the regional boards and funds services to persons with severe mental illness and children with serious emotional disturbances. He said that there is a requirement in the block grant that states a percentage of the funds be set aside for children. There is also a companion requirement that there is a maintenance of effort on the Commonwealth's part to continue to put in its share of funds each year. He said that the funds come from the federal Department for Health and Human Services. The block grant is an annual application due in September.
The next order of business was testimony on charitable pharmacies by Rosana Aydt, R.Ph., Director of the St. Vincent dePaul Community Pharmacy in Erlanger. Ms. Aydt stated that the first obstacle to overcome was to get the law changed to be able dispense physician samples that drug manufacturers provide. Her pharmacy serves 14 counties with 1,300 clients, and 40 to 50 volunteers have logged 5,000 hours per month and have helped deliver $2.6 million in drugs. Recipients have to live in the northern Kentucky area and have no prescription insurance. The drugs are donated by area physicians and grants are written to buy generics and insulin. Senator Roeding stated that the administrative regulation allows this pharmacy to dispense prescription samples donated by physicians, and it is also a wonderful service to seniors and low-income individuals.
The next order of business was consideration of the following administrative regulations: 201 KAR 20:056, 201 KAR 20:095, 201 KAR 20:225, 922 KAR 1:510, and 922 KAR 2:160 & E. Senator Denton stated that there was not a quorum and, therefore, the committee could not vote on the administrative regulations.
Next Ken Green, National Seating & Mobility, testified that the Department for Medicaid Services promulgated an emergency administrative regulation that would put him out of business by cutting reimbursement by 20 to 50 percent and would deny children access to durable medical equipment. Representative Westrom asked Mr. Green if he manufactured wheelchairs, and he said that he did not but he works with several manufacturers that do. The Cabinet for Health and Family Services was directed to meet with Mr. Green to discuss the payment issue.
There being no further business, a motion to adjourn at 3:44 p.m. was made, seconded, and approved by voice vote.