In this episode of Post-Scrip, Henry introduces Jeanne M. Brennan, BS Pharm, JD, and, William J. Stilling, BS Pharm, MS, JD.  They discuss the upcoming Semaglutide as a Case Study for Compounding Legal Issues and BarriersSemaglutide provides a case study for pharmacists who are trying to meet patient and prescriber needs and who strive to comply with federal and state laws and the explosive demand for semaglutide has created opportunities and risks. This demand has created a nationwide shortage of Ozempic and Wegovy. State boards of pharmacy are responding to complaints against pharmacists who are compounding semaglutide.Obesity has been a national health epidemic for years. There is an insatiable hunger for weight loss solutions. Americans want to lose weight. Semaglutide appears to be the newest wonder weight loss drug. Patients and prescribers are touting its effectiveness on social media. The New England Journal of Medicine published a study in 2021 that has provided credibility to the weight loss industry. There are also the STEP trials providing dosing guidelines for weight loss.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Mary Canavan, JD and Kyle A. Vasquez, JD, LLM. They discuss the upcoming 340B Program Preservation and Compliance.In this session, participants will learn how use the 340B statute and guidance to preserve 340B savings. In a climate where manufacturers and payors are uniformly taking action that harms covered entities (and patients), covered entities need to be prepared and start adapting. While manufacturer restrictions have been at the forefront of the 340B industry recently, there are several other stakeholders that are also taking actions that harm 340B savings such as PBMs. As a result of these actions restricting the use of 340B drugs, covered entities have to become creative with how they internally build out their 340B programs, but due to the limited guidance available, the focus on compliance is more important than ever. This session will walk covered entities through case studies that demonstrate how other covered entities are becoming innovators and adjusting their 340B operations to preserve 340B savings. These models assess several areas of compliance, including: 340B, reimbursement, scope of practice, and telehealth.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Christopher R. Smith, JD, LLM. Henry and Chris discuss the upcoming. Drug Supply Chain Security Act Changes and Implications for Dispensers. The presentation will provide an overview of the enhanced drug distribution requirements under the DSCSA and DSCSA interoperable electronic exchange requirements starting in November 2023. Specifically, the presentation will discuss the transition to a fully interoperable electronic system for transaction data exchange at the drug package level and compliance requirements for dispensers. The presentation will further outline new statutory requirements regarding saleable returns and possible changes in government DSCSA enforcement following implementation of the 2023 changes. Finally, our presentation will list the features your pharmacy needs from a DSCSA solution provider, and list resources from the FDA and trade associations that will help ensure that your pharmacy complies with the DSCSA. Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Todd A. Nova, J.D. Henry and Todd discuss the upcoming Current Trends in Retail & Specialty Pharmacy Pricing Compliance: Balancing Opportunity and Risk.The role that retail and specialty pharmacies play in the healthcare delivery system continues to increase in importance as the drug product pipeline continues its inexorable shift to more self-administered and home-infused drugs. This shift has not gone unnoticed by various pharmacy industry stakeholders. The speakers will also address related compliance investigation considerations, including the process for initiating and conducting compliance reviews under the attorney/client privilege and best practices for ongoing monitoring. Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Marty Allain, JD. Henry and Marty discuss the upcoming Emerging Pharmacy Practice Innovation - A Regulatory and Legal Obstacle Course.The session will discuss the emergence of new and non-traditional pharmacy business models that challenge current regulations and supporting legal foundations. Such models are often funded by venture capitalists and led by entrepreneurs who have been successful in other areas and view the pharmacy environment as a similar opportunity. Speakers Edward McGinley and Marty Allain have worked with a number of such start-ups and will share with participants their experiences with these new pharmacy strategies and efforts to bring technological and innovative operations to pharmacy. Inherent to the discussion will be the legal and regulatory requirements that serve as needed safeguards and, at times, barriers to change and implementation. Those attending the session will gain a better understanding of changes that are occurring within pharmacy practice and the impact of such changes on existing practices and legal and regulatory requirements.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Jaya F. White and, JD, Edward D. Rickert, JD/Rph. They discuss the upcoming Infusion Pharmacy Services: Regulatory Considerations Impacting the Business Model.This presentation will discuss infusion pharmacy services and the various business models in the industry, including physician, home, and ambulatory infusion suites. It will look at state law approaches on issues such as licensure, reimbursement/billing, consignment, depoting, and white bagging.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Jennifer L. Adams, PharmD, EdD.  Henry and Jennifer discuss the upcoming Empowering Pharmacists: The Continuum of Prescriptive Authority.Pharmacist prescriptive authority is a topic that has gained significant attention in recent years, as many healthcare professionals recognize the important role that pharmacists can play in improving patient care. With prescriptive authority, pharmacists can prescribe medications and adjust existing prescriptions, which can result in more timely and effective treatment for patients and increased access to healthcare services. Pharmacists in the U.S. practice in a broad array of regulatory environments, as the practice of pharmacy and pharmacist prescriptive authority is regulated by state legislatures and state agencies.As states consider regulation of pharmacist prescriptive authority and increasing pharmacists’ scope of practice, the overarching regulatory model used in the state can facilitate or hinder regulation of pharmacist prescriptive authority. Regulating pharmacy practice with a standard of care regulatory model allows for a more streamlined regulation of advanced clinical services such as pharmacist prescribing.Attendees will leave with skills to articulate how pharmacist prescribing in a standard of care regulatory model allows pharmacists to improve public health through access to healthcare services.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Monet Stanford, PharmD. Henry and Monet dive into The Transition of Biosimilar: From Provider-Administered to Pharmacy-Dispensed. The biosimilars industry, which started with the first approval in 2015, is at an inflection point. In the U.S., biosimilars could lead to over $130 billion is savings by 2025, and have been used in over 364 million days of patient therapy. Until this year, most biologics — and, until adalimumab , all non-insulin biosimilars — are administered by a licensed provider in a healthcare setting and covered under Medicare Part B or the medical benefit of commercial plans.To learn more information about Monet : https://accessiblemeds.org/about/our-team/monet-stanford Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Larry P. Cote, JD. Larry is the Chief Compliance Officer of Smith Drug Company and CEO of Drug Enforcement Analytics LLC, a veteran-owned business that offers software solutions to assist industry partners with meeting their controlled substance compliance obligations.Henry and Larry dive into the upcoming session on Adapting to the New Normal: Practical Tips for Exercising Corresponding Responsibility in an Ever-Changing Environment. This interactive session will discuss recent regulatory developments and how the current environment affects the exercise of corresponding responsibility. We will also explore DEA's expectations of pharmacists and provide practical tips for pharmacies and pharmacists to meet their legal obligations involving controlled substances.To learn more information about Larry and Cote Law : https://cotelawpllc.com/about/ Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Jeff Mesaros, PharmD, MS, JD.  Henry and Jeff discuss Empowering Pharmacists: The Continuum of Prescriptive Authority. Pharmacist prescriptive authority is a topic that has gained significant attention in recent years, as many healthcare professionals recognize the important role that pharmacists can play in improving patient care. With prescriptive authority, pharmacists can prescribe medications and adjust existing prescriptions, which can result in more timely and effective treatment for patients and increased access to healthcare services.This interactive session, presented by experts on pharmacist prescribing and standard of care regulatory models who have experience in multiple states (why we need 3 presenters), will include active learning strategies engaging all session attendees. The session will review the continuum of pharmacist prescriptive authority and the associated advanced clinical services across multiple states. Attendees will leave with skills to articulate how pharmacist prescribing in a standard of care regulatory model allows pharmacists to improve public health through access to healthcare services.To learn more information about Jeff : https://cpha.com/amo-team/jeff-mesaros/Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces  Roger N. Morris, JD, RPh. Henry and Roger discuss this years case law update. ASPL’s annual case law update will provide summaries of court decisions, lawsuits, and settlements from the last twelve months. The presentation will explore a variety of civil and criminal cases at the state and federal level involving pharmacy employment issues, fraud claims by employees and the government (e.g., False Claims Act cases), negligence (malpractice), managed care, disciplinary actions by regulatory boards, controlled substances, and more.  Whether you are an attorney, pharmacist, compliance officer, or work in any area related to pharmacy law, this fast-paced overview will inform you of the most important legal decisions affecting your practice.To learn more information about Roger : https://www.quarles.com/people/roger-morrisJoin us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry introduces Lemrey A. Carter, PharmD, MS, RPh. Listen as they unpack top issues and initiatives that will impact pharmacy regulation moving forward, how state Boards of Pharmacy may handle them, and tools and resources NABP will provide them to assist their efforts in protecting public health. Such items as Drug Supply Chain Security Act, FDA proposed rules on licensure standards, post-Dobbs activity, scope of practice changes and digital health amongst other topics are all trending items that will impact pharmacy practice moving forward.To learn more information about NABP : https://nabp.pharmacy/Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

In this episode of Post-Scrip, Henry welcomes Dr. Erin Albert with Mark Cuban Cost Plus Drug Company, PBC, and Dr. Patrick Carpenter with Option Care Health to unpack the ASPL Diplomat program. The Diplomat of the American Society for Pharmacy Law (DASPL) is awarded following a  year-long focused series of programming for mid-career professionals in pharmacy or pharmacy law (5+ years of practice or more) to hone their leadership skills in pharmacy law and learn more about involvement within the Society. This program takes the next generation of pharmacy law leaders through various topics germane to pharmacy law, pairs mentors/mentees, and provides an avenue for future leaders to share their passions in pharmacy law through a year-long capsule project.  To learn more about the ASPL Diplomat Program, visit www.aspl.org/dasplNow accepting applications for the 2023/2024 DASPL Class II. Be sure to read the 2023/2024 FAQ Document before starting the application process.  Deadline to apply is July 15, 2023.Join us at the 34th annual conference:  Developments in Pharmacy Law Seminar , November 2-5, 2023 in San Antonio, Texas

Today we welcome Mark Ogunsusi, PharmD, Esq. and  William H. von Oehsen, Esq. with Powers Pyles Sutter and Verville PC. Mark and Bill give insights to their conference talk unpacking Critical Policies, Arguments, and Expectations regarding Section 340B of the Public Health Service Act. Enacted in 1992, Section 340B entitles certain safety-net providers to purchase from manufacturers outpatient drugs at a deeply discounted ceiling price defined by the 340B statute. Drug manufacturers agree to provide the 340B discount in exchange for their drugs being reimbursed under the Medicaid and Medicare Part B programs – two important markets for most manufacturers. For nearly three decades, the safety net hospitals and clinics participating in the 340B program – referred to as “covered entities” in the statute -- have dispensed their 340B drugs through independent pharmacies operating under contract with covered entities. These contract pharmacy arrangements allow covered entities to extend the reach of their 340B pharmacy programs to more patients and are especially important for hospitals and clinics that lack their own in-house pharmacies. Finally, the presentation will discuss federal and state bills aimed at curbing the manufacturers’ restrictive policies, and key predictions for the future of 340B contract pharmacy arrangements.The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.  Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.  We look forward to having you join us in November!

In this episode, we welcome Simone Colgan Dunlap, JD with Quarles & Brady LLP. Simone gives our listeners a glimpse into her conference topic entitled: "Double, Double Toil and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions." She also  shares how she got her beginnings in the industry.  This presentation will address key regulatory considerations implicated by pharmacy interactions with hubs--with a playful Shakespearian twist. If you have ever thought that hubs are greek to you, this presentation will give you the wings wherewith to fly confidently into the evolving world of hubs. Hubs play a unique role in the ecosystem of drug delivery and patient care and take on varied forms. As patient access strategies continue to evolve, all pharmacies should be prepared to navigate hub interactions. As the Bard said, “better three hours too soon, than a minute too late”!The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.  Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.  We look forward to having you join us in November!

In this episode, we are joined by Eman Kirolos, PharmD, RPh, MS - Walgreens. Eman shares some of how she got started in the industry, her experience in the ASPL Diplomat program, as well as a preview of her capsule presentation entitled: "Efforts and Policy Recommendations to Address Pharmacy Working Conditions as a Critical Element to Patient Safety." The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.  Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.  We look forward to having you join us in November!

Today we welcome Jeff Mesaros, PharmD, JD with Ro. Our host Henry Hine explores the fascinating journey Jeff has taken throughout his career, as well as unpacking the premise of his seminar topic entitled: "Test & Treat." Pharmacy-based Test and Treat programs increase access to health care by allowing pharmacists to perform appropriate assessments and diagnostic tests and to treat patients based on the results of those tests. Throughout COVID-19, pharmacies have stepped up to close a gap in care and improve health equity throughout the United States. Many states lack the regulatory framework to continue this valuable patient care service in the absence of the PreP Act allowances. This program will serve to review the regulatory framework of Arkansas and Florida and provide lessons learned for other states to work with regulatory agencies to maintain this standard of care. The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.  Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.  We look forward to having you join us in November!

We are pleased to be joined today by Marty Allain, JD and Jennifer Baumgartner, PharmD, BCPP with REAL Solutions Group to share a bit about their careers and their upcoming talk at the National Conference entitled "Pharmacist Prescriptive Authority: Give Me That Pen!"The slow, methodical grind of expanding pharmacist prescribing authority sounds eerily like a train gaining scant momentum on a rusty iron track. But progress is upon us as COVID has proven pharm​acy to be an effective and easily accessible wellness destination while select states continue to expand prescribing authority. The fight is ongoing throughout State Houses around the country. Medical associations battle, scheme, and harass non-physician professions into submission legislative session after session, but history will prove that doctors were on the wrong side of progress. The presentation will provide a brief overview of the history of pharmacist scope of practice along with insights on pharmacist prescribing regulation and engagement around the continuum of pharmacist prescriptive authority. Pull out our Rx pads and pens, pharmacists, it’s time to write! The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.  Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.  We look forward to having you join us in November!

We're honored to have Jay Warmuth, JD & Jane Blaney, JD of Faegre Drinker Biddle & Reath LLP  to the program to give a preview into their conference presentation: "Developments in Laws and Regulations Impacting PBMs and Prescription Drug Access." At the National Conference, this presentation will provide an overview of recent developments in PBM regulation and explore questions such as: Who are these laws and regulations designed to protect? What are the goals or objectives of the regulations? And are those objectives being achieved? They also will address a number of challenging legal issues that oftentimes arise in the context of these laws and regulations, including issues of federal statutory preemption and the cross-border application of certain state laws to multi-state or national health plan clients. The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.We look forward to having you join us in November!

In this episode of Post-Scrip, our host Henry Hine is joined by Scott Pace, PharmD, JD of Impact Management Group / Kavanaugh Pharmacy. Scott gives us a preview of his upcoming presentation of Test & Treat  for community pharmacies and shares a bit about his fascinating background in the industry. Pharmacy-based Test and Treat programs increase access to health care by allowing pharmacists to perform appropriate assessments and diagnostic tests and to treat patients based on the results of those tests. Throughout COVID-19, pharmacies have stepped up to close a gap in care and improve health equity throughout the United States. Many states lack the regulatory framework to continue this valuable patient care service in the absence of the PreP Act allowances. This program will serve to review the regulatory framework of Arkansas and Florida and provide lessons learned for other states to work with regulatory agencies to maintain this standard of care.   Scott will be presenting with Jeff Mesaros, PharmD, JD - Ro  to dive deeper into this topic at the ASPL National Conference. The 33rd annual American Society for Pharmacy Law Developments in Pharmacy Law seminar will be held November 3-6 at the Naples Grande Beach Resort in Naples, FL. The Seminar is being held in-person this year! Don't miss this opportunity to learn, share and network with seasoned legal and pharmaceutical professionals.Attendees will have the opportunity to earn up to 15 hours of ACPE and CLE continuing education credits.We look forward to having you join us in November!