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PHARMACON EXPO 2018

DR.GORDON J. VANSCOY

DR. MICHAEL CASTAGNA

Chairman and CEO of PANTHERx Specialty Pharmacy

CEO of Mannkind Corporation

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PHARMACON JUNE 8-9 | Orlando, FL

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harmaCon was borne out of a desire to educate independent pharmacy owners about the ever-changing landscape of the pharmaceutical field. A few of our goals for PharmaCon were to provide an update and assist in the understanding of pharmacy benefit managers, increase collaboration between pharmacists and physicians, and explore the niche market of specialty pharmacy.

PBM PANEL DISCUSSION State and federal lawmakers are beginning to crack down on PBMs but not many people know what their true purpose is or how much they truly affect pharmacies. For PharmaCon, we sought out qualified individuals to speak on the subject and these individuals include: 2 former Florida Pharmacy Association (FPA) Presidents, 2 health care attorneys and 1 independent pharmacy owner.

TOM CUOMO, former FPA president, is the president and a consultant pharmacist for Gulf Coast Pharmacy Consultants in Clearwater, Florida. He is certified in medication therapy management and is also a former chairman of the board for the FPA. ALLEN DAVID KNEE, another former FPA president, is the CEO and principal consultant of Apothecary Consultant Group, a pharmacy consulting firm specializing in PBM and regulatory audits, quality assurance, accreditation, licensing, and compliance. DANIEL STERNTHAL is a member of Baker Donelson’s Health Law & Public Policy Department which is regarded as one of the premiere health law practices in the country. It has been nationally ranked by Modern Healthcare, Chamber USA—America’s Leading Lawyers for Business, Health Lawyers News and other health care publications. Mr. Sternthal concentrates his practice on advising clients on issues relating to regulatory, operational and corporate matters and has assisted pharmacies address matters involving payment and reimbursement, investments and offering documents, licensure, and changes of ownership. Mr. Sternthal is an adjunct professor at the University of Houston School of Law. In 2008, he received the UNT Time and Talent Award for Distinguished Service. JEFF DAVIS, a senior adviser in Baker Donelson’s Government Relations and Public Policy Group, helps clients navigate policy and legal issues surrounding pharmacy and drug purchasing, including the 340B drug pricing program, as well as Medicare and Medicaidrelated compliance requirements. He provides clients counsel on legal issues as well as strategic advice on advocacy and policy issues. JAMES WRIGHT is a pharmacist and former FPA Government Affairs Committee member. He is currently owner of Five Points Pharmacy and Wellness.

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AT T N : THERE ARE Pharmacon free passes!

PHARMACIST-PHYSICIAN COLLABORATIVE PRACTICE PANEL DISCUSSION Another goal of ours was to foster a more cohesive relationship between pharmacist and physician to improve patient care. Are there things that can be done to allow patients to have more time with their physicians? Can pharmacists assist in tasks other than MTMs and immunizations? We explore this topic in depth with several qualified speakers including: Dr. Cristina Cortes, Dr. Kevin Olson, Dr. Adel Eldin, and Dr. Sarah Hurty.

DR. CRISTINA CORTES is a board-certified internist who completed her internal Medicine training at Mount Sinai Medical Center in Miami. She recently helped open NOVU Dermatology and Internal Medicine in Orlando, Florida. DR. KEVIN OLSON is a pharmacist with an MBA who focuses on collaboration with internal and external stakeholders, and across all levels of organizations, to drive innovation, strategic planning, business development, and business process improvement. He is currently an assistant professor at the University of South Florida’s College of Pharmacy and the University of Tampa. DR. ADEL ELDIN, FACC, FACP, has been in private medical practice in Florida for 20 years with Brooksville Cardiology. His work is known nationally for patient advocacy, seniors’ rights, education, and community outreach. He is the proud recipient of many prestigious awards including best small business of the year, First Humanitarian Award, and special recognition from President Barack Obama for serving the community, to name a few.

SPECIALTY PHARMACY SPECIALIST GORDON VANSCOY With more than three decades of executive experience creating and developing successful medical and pharmaceutical service business ventures, Dr. Vanscoy is a leader in the healthcare industry. He is the founding chairman and CEO of PANTHERx Specialty Pharmacy (SP), the nation’s leader in rare disease specialty pharmacy services. PANTHERx is a quad-accredited SP consistently recognized by INC Magazine as one of the fastest growing companies, and by Modern Healthcare as one of the best places to work in the United States. In addition, PANTHERx Specialty Pharmacy has won the Zitter Health Insights Patient Satisfaction Award, receiving the highest score ever attained on the survey. Gordon also serves as the associate dean for business innovation and associate professor of pharmacy and therapeutics at the University of Pittsburgh (Pitt), where he launched the Master of Science in Pharmacy Business Administration degree program. Recently, Dr. Vanscoy was conferred the Pitt’s highest recognition as a Distinguished Alumni Fellow. Gordon received his Bachelors of Science in Pharmacy and Masters of Business Administration degrees from the University of Pittsburgh, and his Doctor of Pharmacy degree from Duquesne University. He has completed an ASHP-accredited clinical residency at The Mercy Hospital of Pittsburgh and a faculty fellowship in advanced geriatrics at the University of Pittsburgh Geriatric Education Center.

DR. VANSCOY has published a number of textbook chapters and over 200 scientific papers and abstracts. He has received dozens of research and educational awards and grants, provided hundreds of invited lectures, and served on many national and international boards. He is a past member of the ACPE National CE Provider Committee, the International Society of Pharmaceutical Outcomes (ISPOR) Board of Directors, a member of the Board of Directors at the ASHP Foundation, and the United States Pharmacopoeia’s (USP) Therapeutic Information Management Advisory Panel. Dr. Vanscoy is a cofounder of the credentialing entity, the Certified Anticoagulation Care Providers (CACP). Dr. Vanscoy currently serves on the Board of Directors of the National Association of Specialty Pharmacy.

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How Physician and Pharmacist Integration Generates Innovation BY BRANDON K. WELCH, B.S.

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oth professions went to school so that they can perform at the top of their license and modernize today’s health care era; bringing revolutionary solutions to the health care industry. It’s already apparent that we prefer to avoid the administrative burden, as it disrupts our workflow and takes time away from spending with the patient. Both professions went to school so that they can perform at the top of their license and modernize today’s health care era; bringing revolutionary solutions to the health care industry. It’s already apparent that we prefer to avoid the administrative burden, as it disrupts our workflow and takes time away from spending with the patient. Our reimbursement model has changed and went from fee-for-service to now value-based care. Physicians are the first point of contact to diagnose and assess appropriately, while pharmacists are the last line of defense to verify that that appropriate treatments were prescribed. It’s clear that

both professions possess a high pedigree of clinical knowledge. Why do we separate the 2 entities, instead of bringing them closer together? Participation in a care-team program with a physician and a pharmacist can ease the burden associated with the management of complex-care patients. It also provides a way to better manage the cost of these patients by optimizing their health and functional status, decreasing excess health care use, minimizing emergency department visits and other hospital utilization (including readmissions), and preventing long-term nursing home placement. What’s going on in the physician private practice world is also going on in the pharmacy private practice world. According to the American Medical Association, less than half of physicians own their medical practice, and this is the first time it has been this low.1 According to the National Community Pharmacist Association (NCPA) digest report, there has been a steep drop in

Physicians didn’t spend long years in school to have two-thirds of their work comprise of data entry task. Pharmacists didn’t spend long years of school to have two-thirds of their work-day consist of filling and dispensing medications. independently-owned pharmacy practices compared to previous years.2 Ownership and employment shifts reflect the industry’s increasing compliance costs and n ew payment models. Health systems have been aggressively mopping up the physician practices, while the large-chained pharmacies have been aggressively mopping up the smaller independent pharmacies. The common reasons shared for selling their practice: 1. Low reimbursements 2. High overhead cost 3. Burnout 4. Increased competition by bigger players 5. Lack of innovation With the collaboration of physician and pharmacy private practices, it can help eradicate a bulk of the problems both professions face and help revolutionize health care.

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HOW CAN A PHYSICIAN ASSIST A PHARMACIST?

WAYS A PHARMACIST CAN HELP IMPROVED VALUE-BASED CARE MODELS FOR PHYSICIANS INCLUDE:

1. Pathophysiology: Physicians are experts and well-trained in the pathophysiology of a patient. Physicians are sharply intelligent in diagnosis criteria and general assessment of a patient.

1. Disease-state management therapy: Most physicians are trained only to know the contraindications of medications for individual disease states. Where they may lack is the pharmacokinetics/pharmacodynamics profile, medicinal chemistry, and the robust intelligence of clinical literature of drugs in certain classes. All of these small intangible things relating to a drug have a significant impact on its effectiveness.

2. Medical Knowledge: Physicians have the medical knowledge to help consult with patients on preventive skills to live a more proactive healthy lifestyle. The more time the physician has with the patient, the better the outcomes. Physician and pharmacist collaboration has the potential to create a robust health system for patients and also produce a stronger buy-in from insurance companies. Population health is the current and future trend of health care. We can start synergizing our talents and bring out the best in value-based care practice models. The more prominent players are already adopting vertical integration strategies to help create a more userfriendly and efficient health care system. Why can’t we? In essence, we have to STOP advertising and START innovating.

2. Primary care pharmacist plans: Yes, pharmacists can provide care plans. A clinical pharmacist can also put together a care plan to better assess the patient and provide useful treatment recommendations for the physician’s review. This can help reduce the administrative task physicians may have to deal with, which in return allows the physician to spend more time with their patient to go over the pathophysiology of their condition.

3. Pharmacoeconomics: Pharmacists have the due-diligence training to evaluate the cost and effectiveness of a pharmaceutical agent against another. This can be referred to as a cost-benefit analysis. Hence, pharmacoeconomics can help guide optimal health care resource allocation and provide more buy-in from insurance companies. ®

AUTHOR BIO Brandon K. Welch, B.S., president of American Pharmacy Purchasing Alliance (APPA) has more than 10+ years of sales experience and several years of experience working in specialty pharmacy, ultimately gaining experience in banking, marketing, branding, business development, specialty pharmacy sales, and business operations. He is currently the President for the American Pharmacy Purchasing Alliance.

REFERENCES 1. Kacik A. For the first time ever, less than half of physicians are independent. Modern Healthcare. http://www.modernhealthcare.com/article/20170531NEWS/170539971. Published May 31, 2017. Accessed April 25, 2018 2. NCPA Releases 2017 Digest [press release]. Orlando, Fla. NCPA website. http://www.ncpanet.org/newsroom/news-releases/2017/10/16/ncpa-releases-2017-digest. Published October 16, 2017. Accessed April 25, 2018.

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How Independent Pharmacies Can Get Access to Limited Distribution Drugs

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ow many times has a patient presented to you a prescription for a “specialty” medication that you are unable to fill? It could be that you are not able to order the medication from your wholesaler. Or worse, the patient’s insurance is mandating a specific pharmacy different than yours. It can be frustrating when a current or prospective customer is coming to you, the pharmacist, for a solution to their chronic and sometimes rare, condition. There is no finite definition for what qualifies as a “specialty” medication. In general, specialty medications are used to treat chronic or complex conditions and usually require special handling or administration and close monitoring of the patient. Sometimes, these prescription medications are indicated for rare diseases, which means that the disease affects less than 10,000 people. They are therefore given “orphan drug status” under the Orphan Drug Act of 1983.

This act allows for fast-track FDA approval for drugs intended to treat these rare diseases due to limited therapies available on the market. Obtaining fast-track approval allows the medicine to be available as quickly as possible to the patients that need it the most. This also means that the medication does not have to go through as many lengthy clinical studies as the more “traditional” therapies. Often, as a stipulation of being given fast-track approval status, the FDA may require additional aftermarket studies to be completed, meaning that the drug is available to be prescribed but the patients taking the medicine are monitored for safety and efficacy of the therapy. This is referred to as a phase 4 clinical trial. Any pharmacy that dispenses one of these drugs must understand this process and accommodate the patient and drug manufacturer for any required documentation or data.1,2

Some specialty drug manufacturers may limit the number of pharmacies who have access to order their medication. These are deemed “limited distribution drugs,” or LDDs for short. When attempting to order one of these medications from a wholesaler, you may notice that the drug’s name is not listed in the system. Or it may take you straight to a screen that reads, “due to manufacturer limitations, this product is only available through a limited distribution network” and to contact the manufacturer directly. This can be very disheartening for a pharmacist or pharmacy owner. Upon calling the manufacturer, you may find out that to gain access to this drug, there are many rigorous requirements to meet first. It is also worth mentioning that all manufacturers are different and have different specifications that must be met. Many require weekly data reports so it would be prudent to know if

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your pharmacy’s dispensing software can accommodate customized and automatic reports. The manufacturer may also request proof that you, as the pharmacy, have a way to monitor the patient for adherence and therapy response. A common theme among these manufacturers is some sort of “specialty accreditation.” This is often the first step to becoming a specialty pharmacy. Achieving accreditation proves a commitment to quality and standards that are becoming the norm in the specialty space. Accrediting bodies such as the Accreditation Commission for Health Care (ACHC) and the Utilization Review Accreditation Commission (URAC) are arguably the most reputable in the field. Both sets of standards set the stage for core activities such as: • Patient care • Coordination of care and/or delegation • Information management • Compliance program • Quality Management And Continuous Quality Improvement Accreditation is strongly recommended but could become mandatory by payers in the near future to ascertain preferred

contracts for reimbursement purposes. This means extra revenue for your pharmacy by adding a specialty line of business. The entire process can take from 6 months to a year for full accreditation and can be very arduous and labor intensive. If all of this sounds intimidating, just know that you are not alone. The key is to connect with a professional who has been through the process. Ideally, they should have been able to achieve and have maintained accreditation for some time. Embarking on a project such as this size could be overwhelming and a competent expert can guide you through the process. There are many resources available though, if you choose to take on a project independently. However, there is a lot of competition out there in specialty pharmacy but accreditation can set you apart from others. Visit ACHC.org or URAC.org to learn more about the various programs in accreditation and visit joinappa.com.Specialty for a free consultation and to learn more about guidance through the process.3,4 APPA provides necessary paperwork required for accreditations such as policies and procedures and staff training documentations and will also assist you in preparing you and your pharmacy staff for on-site surveys. All services are customizable and personalized to individual business needs. ®

AUTHOR BIO Lindsay Wall is a Doctor of Pharmacy graduate from South University in Savannah, GA. She has over 15 years’ experience in community retail pharmacy as well as extensive experience in accreditation and structural organization development for pharmacy. Her recent experience includes the title of Specialty Director for a large independent pharmacy chain where she led her department in several new program implementations including a prior authorization team, naloxone standing order protocol procedures, and specialty pharmacy contracting and accreditation.  She is also an officer of the Hillsborough County Pharmacy Association (HCPA) where she is the Vice President of Business and Development and created their website (www.hcpaflrx.com) and social presence. Lindsay is also the Specialty Pharmacy Consultant for the American Pharmacy Purchasing Alliance.

REFERENCES 1. FDA Working to Lift Barriers to Generic Drug Competition. FDA website. https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drugcompetition/. Accessed April 25, 2018. 2. Developing Products for Rare Diseases and Conditions. FDA website. https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm Accessed April 25, 2018. 3. What is accreditation? ACHC website. https://www.achc.org/about-accreditation.html#what-is-accreditation Accessed April 25, 2018. 4. Pharmacy Quality Management Programs. Community Pharmacy Accreditation. URAC website. https://www.urac.org/programs/community-pharmacy-accreditation Accessed April 25, 2018.

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