Kim Harvey Looney
Applicant, Kim Harvey Looney, Attorney at K. & L. Gates, LLP, proposes a comprehensive application for specialty pharmacy and home infusion services in multiple states. The application focuses on initiating home health services, specifically infusion therapy for patients receiving specialty medications dispensed by KabaFusion pharmacy. The proposal seeks CON for 93 counties in a particular state, excluding Lake and Perry due to being underserved. The need for home infusion therapy is highlighted as more complex and specialized than traditional home health services, with KabaFusion positioned to offer advanced nursing care. Patients' access to specialty home infusion therapy is contingent upon the approval of this CON and subsequent home health license. The applicant distinguishes itself by providing highly skilled staff and extensive nursing hours, catering to patients' needs with reimbursement primarily from commercial payers and Medicare Advantage plans.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Kim Harvey Looney Attorney, K & L Gates, LLP
Applicant is national provider of specialty pharmacy and home infusion services (40 states) Presented as one application: Voted on separately Initiate home health services limited to infusion therapy for patients receiving specialty medications dispensed by KabaFusion pharmacy Entire State: CON for 93 counties (CON not necessary for Lake and Perry because underserved) KabaFusionTN, LLC CN2405-012 CN2408-021
Traditional population-based need formula not met, but formula not applicable to need for home infusion therapy services proposed by applicant Home infusion therapy more complex and specialized than traditional home health services Traditional home health agencies do not typically provide specialty home infusion therapy services not trained or staffed to provide extensive nursing hours Other current HH agencies in TN providing home infusion therapy services are limited to their own pharmacy patient population Need
Applicants patients are unable to receive specialty home infusion therapy without the approval of this CON and subsequent HH license. Home infusion therapy providers are limited to their own patients and cannot provide services for the applicant s patients. Traditional home health agencies do not provide specialty home infusion therapy services; the services they provide are limited to shorter, more frequent visits generally for non-chronic conditions (no duplication of services). KabaFusion will receive reimbursement primarily from Commercial payers and Medicare Advantage plans. KabaFusion s charges are reasonable in comparison with other infusion therapy providers in state any difference in charges is due to KabaFusion providing more highly skilled staff and higher number of nursing hours per visit Consumer Advantage Attributed to Competition
Applicant will apply for HH licensure through Tennessee Health Facilities Commission Applicant is currently accredited through the Accreditation Commission for Health Care (ACHC) a deemed Medicare accrediting organization for Infusion Pharmacy, AIS, Infusion Nursing KabaFusion compliant with Medicare and ACHC required Quality Standards under current Medicare # focusing on patient safety, patient satisfaction, timeliness of response to patient concerns, mgmt. of adverse events, patient education, billing and coding issues Quality
Karen Kaczmarek RN, BPS, RPT, CHC, IgCN Chief Nursing Officer, KabaFusion
State-of-the-art compounding pharmacies 33 Home health agency offices servicing 40 states for infusion nursing Extensive specialized training for Nurses and Pharmacists Multidisciplinary Team Approach key to positive patient outcomes Infusion Therapy versus Traditional Home Health Services Infusion therapy: Infusion Nursing only by Registered Nurses Traditional HH services: Skilled Nursing (RN/LPN), OT, PT, ST, HHA KabaFusion Overview
Typical chronic patient receives IVIG 3-5 days every 4 weeks with infusions lasting 4-8 hrseach day Immune compromised patients receive infusions either via IVIG (typically monthly) or SCIG (typically weekly) RNs require expert IV skills, specialized training regarding the infusing of medication, patient assessment, management of adverse events All infusions require RN administration and monitoring of infusions to assess clinical status and tolerance of infusion Description of Patients
Limited Distribution Manufacturers ADMA Biologics Kedrion/BPL BioPharma US General Manager UCB Patient Assistance Program/Manufacturer Octapharma US GC Biopharma USA Medical Community KabaFusion Support Metro Infectious Disease Specialists, Nashville, TN Dr. Salmaan Muneer/ER Physician, Nashville, TN Dr. Derek Damin, MD, Vanderbilt Asthma, Sinus & Allergy Program Murray Neurology and Sleep Center, Murray, KY KabaFusion Huntsville, AL pharmacy
ACHC Accreditation/Medicare Quality Standards Performance Improvement/Quality Management Program Monitoring and auditing patient care services Adverse events Re-hospitalization Infection tracking Patient satisfaction Management of complaints Evidence-based practice review Ethical issues Medication errors Safety issues Quality Standards Measured by KabaFusion
Binoy Joseph, Pharm.D. AVP of Operations, KabaFusion
Neuromuscular diseases such as CIDP, Myasthenia Gravis, MMN, Stiff Person Syndrome, Myositis, MS Immune Deficiency diseases (>250 diagnoses) Autoimmune inflammatory diseases such as Rheumatoid Arthritis, Crohn s disease Dermatological diseases such as pemphigus and bulbous disorders of skin Pre-or post-transplant infusions to help body accept donated organ Pediatric patients: PANs/PANDAs or other encephalopathies Chronic Conditions Treated
Intravenous immune globulin (IVIG) Subcutaneous immune globulin (SCIG) Specialty Infusion Medications for Chronic Diseases that require RN Administration Vyvgart and Vyvgart Hytrulo Rystiggo Monoclonal Antibody Medications Tumor Necrosing Factor Medications Parenteral Nutritional therapy End Stage Cardiac therapies Anti-infectives Therapies/ Medications Provided
KabaFusionBenefits Access to multiple Limited Distribution Drugs (all IG products/ multiple IV specialty meds) Availability of home infusion services reduces or eliminates travel time and expenses for patients Staffing: Only RNs and pharmacists trained in infusion therapy Only pharmacy in Tennessee approved for home use of Rystiggo
Karen Kaczmarek RN, BPS, RPT, CHC, IgCN Chief Nursing Officer, KabaFusion
Patient Story Examples Southern TN patient traveling every month to Northern AL to receive treatment Neuromuscular patients that may be bedbound and are able to progress to ambulatory status after multiple infusions
Medicare Reimbursement Proposal Senator Marsha Blackburn Congresswoman Diana Harshbarger
