In this episode of Post-Scrip, Henry introduces Jenni Wai, RPh. , MBA, Josh Bolin and Christopher R. Smith, JD, LLM. They discuss the upcoming "Regulatory, Industry and Legal Perspectives on the Future of the DSCSA".This presentation will provide an update on the final stages of implementation of the DSCSA and anticipated future regulatory efforts. We will begin with a brief high level overview of the DSCSA, including a summary of recent regulatory developments, such as any new regulations or...

In this episode of Post-Scrip, Henry introduces Marty Allain, JD. They discuss the upcoming "How Drug Manufacturer Restrictions and Recent Court Decisions are Re-Shaping 340B Drug Distribution and Delivery Models".Pharmaceutical manufacturers continue to restrict the delivery of 340B drug discounts to contract pharmacies in response to the growth of 340B sales, perceived non-compliance with 340B program requirements, and statutory interpretation. These restrictions have a significant financia...

In this episode of Post-Scrip, Henry introduces Amanda Ward, PharmD, MS, BCGP. They discuss the upcoming "DASPL Class II Capsule Projects". As pharmacists continue to move beyond traditional roles in a dispensing pharmacy, state boards of pharmacy may have additional types of licensure pharmacists must have to perform those services. A review of all 50 states boards of pharmacy will reveal if the pharmacists must license their non-dispensing services as a pharmacy or if their licensure a...

In this episode of Post-Scrip, Henry introduces Roger N. Morris, JD, RPh. They discuss the upcoming "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), manag...

In this episode of Post-Scrip, Henry introduces Jeff Mesaros, PharmaD, MS, JD. They discuss the upcoming "Pharmacy Law Educators' Session - Using AI in the classroom". This session begins with a presentation of using AI in the classroom followed by a panel session addressing implementation and regulation of AI in pharmacy practice.Join us at the 35th annual conference: Developments in Pharmacy Law Seminar , November 7-10, 2024 in Phoenix, Arizona

In this episode of Post-Scrip, Henry introduces Jeffrey S. Baird, JD. They discuss the upcoming "Advising a Pharmacy on Compliance Issues: Ethics Concerns". Health care attorneys are in a unique place. When they advise health care providers (e.g., pharmacies), there are civil implications, potential criminal implications, and there are ethical challenges. This program will discuss (i) ethical challenges that health care attorneys face and (ii) steps to address the challenges. Specif...

In this episode of Post-Scrip, Henry introduces Kelli A. Boyden, JD; MS Pharmaceutical Sciences (Regulation) (2024). They discuss the upcoming "Key Supreme Court Decisions Impacting Pharmacies". This presentation will focus on The U.S. Supreme Court’s rulings this year carry real-world effects on the pharmacy industry, including the FDA’s approval of mifepristone and addressing the standard for how courts defer to agencies. We will review these key Supreme Court’s decisions and discuss w...

In this episode of Post-Scrip, Henry introduces Douglas Braun, PharmaD, RPh, CPh, CSP. They discuss the upcoming "Impact of Inflation Reduction Act on Prescription drug costs, access and the financial impact of Medicare D reimbursement."The implementation of the Inflation Reduction Act in 2024 has a significant impact on both pharmacies and patients. Patients covered under Medicare Part D will see potentially significant savings from capped insulin costs to major reductions in total out-of-po...

In this episode of Post-Scrip, Henry introduces Steven Postal, JD. They discuss the ASPL publications editing.Steve Postal is the Publications Editor at ASPL and the Director of Policy and Regulatory Affairs at NCPA. His areas of expertise include Medicare Part D, compounding, and Medicaid. Before joining NCPA in April 2022, he worked for the American Physical Therapy Association in federal regulatory affairs.Join us at the 35th annual conference: Developments in Pharmacy Law Seminar, N...

In this episode of Post-Scrip, Henry introduces Anthony P. Morreale, PharmD, MBA, BPCS, CPEL, FASHP. They discuss the upcoming "Pharmacogenomic Explosion: Legal and Liability Implications". This presentation will focus on the rapid advancement of the science and its impact on prescribing and managing drug therapy and the consequences of ignoring pharmacogenomic evidence that is now present in well over 300 FDA approved medication prescribing information documents.Integration of pha...

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 Barriers Semaglutide 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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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),...

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...

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...

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...