There has been a great deal of activity surrounding the 340B program this year. We’ve seen its core stakeholders reacting and anticipating the consequences of these changes, all the while, still in the midst of managing the impact of the pandemic and economic downturn that’s ensued. This day-long webinar series highlights the most pressing issues both 340B covered entities and manufacturers need to consider to develop appropriate strategies around their 340B program initiatives. Participate in one or all of the sessions of the day to stay abreast of the latest information, impacts, and recommendations for effective and compliant program participation.
340B Report is the only subscription-based news service that provides breaking news and analysis about the federal 340B Drug Pricing Program. We follow all 340B program developments big and small—in federal government agencies, Congress, courts, the states, associations, the private sector, academia, and more. If your success rides on staying on top of 340B, 340B Report has you covered.
Apexus - 304B Prime Vendor
Apexus serves as HRSA’s Prime Vendor for the 340B Drug Pricing Program. We provide access to medications, education and compliance needs and manufacturer refund services.
Founded nearly 50 years ago and employing over 2,500 clinical, regulatory, and operational pharmacy professionals, Comprehensive Pharmacy Services is the nation’s oldest and largest provider of pharmacy management and support services to more than 700 hospitals and healthcare facilities across the United States and Puerto Rico.
Sidley’s healthcare lawyers help clients meet the challenges they face in today’s rapidly changing enforcement, regulatory, and scientific environments. We represent drug, device and biotech manufacturers, as well as hospitals, research institutions, clinical laboratories, dialysis providers, health information technology companies, medical equipment suppliers, pharmacies, skilled nursing facilities, medical groups, physician-owned companies and professional associations.
Threats and Opportunities in the 340B Program – Impact of Recent Business, Legislative, and Policy Developments
As we get closer to Election Day, the 340B program is back in the public eye, and under an intense microscope. An active year already, punctuated by the impact of the pandemic, stakeholders have seen significant action on 340B including the following –
a growing dispute between providers and manufacturers around contract pharmacy arrangements;
next steps in the dispute including possible legal and legislative action;
the federal appeals court ruling on Medicare Part B reimbursement and CMS’s efforts to decrease reimbursement rates further;
the Trump Administration’s Executive Orders on drug pricing, including pass-through of 340B discounts for insulin and EpiPens;
state actions to prohibit PBMs from discriminating against 340B entities and implications of recent court cases.
During this opening session of the 340B webinar series, examine where we are, how we got here, what to expect moving forward, and the potential threats and opportunities for various stakeholders involved in the 340B program.
Outline recent activity by key industry players, regulators, courts, and policymakers
Explore recent developments in state capitols impacting 340B stakeholders
Examine the upcoming Presidential and Congressional races and their impact on drug pricing and the 340B program
Ted Slafsky Publisher and CEO 340B Report View Bio
Peggy Tighe, JD Principal Powers Pyles Sutter & Verville PC View Bio
Publisher and CEO 340B Report
Ted Slafsky is one of the nation’s leading experts on health care policy, pharmaceutical pricing, the hospital industry and health care access. Based in Washington, D.C., he is Founder and Principal of Wexford Solutions LLC where he consults with businesses and non-profits looking to strengthen their position in the marketplace and improve health care outcomes.
Mr. Slafsky is also the Publisher and CEO of 340B Report, the only subscription-based news service covering developments in the federal 340B drug pricing progam.
Mr. Slafsky speaks at industry conferences and events. Clients include established firms, health care start-ups, health care institutions and non-profits. Mr. Slafsky is frequently quoted in the news and is one of the nation’s leading experts on pharmaceutical and health care matters impacting low-income and other vulnerable patient populations. His opinion pieces have been published in various national publications including USA Today Health Affairs, The Hill and Roll Call. Mr. Slafsky has excellent bipartisan relations with Congress and the administration. He also has close relationships with many leading hospital executives, pharmacy directors and pharmacy industry leaders.
Prior to his new venture, Mr. Slafsky served as President and Chief Executive Officer of 340B Health, a Washington D.C.-based association of over 1400 hospitals nationwide participating in the federal 340B drug discount program. The program enables hospitals and clinics serving large numbers of low-income patients to stretch scarce resources and expand access to care. It is a critically important program for hospitals, community health centers, Ryan White clinics and other providers serving vulnerable patient populations. Thanks to the program, patients are able to access affordable medications and improved health care. Mr. Slafsky served as President and CEO of the organization from 2010-2018. From 1996-2010, he was Executive Director. During his tenure, he grew 340B Health’s membership from 50 hospitals to over 1300 hospitals and increased its budget from $50,000 to over $10 million. He also oversaw its growth from 2 employees to over 30, as well as oversaw the work of 10 prominent consultants including former U.S. lawmakers from both parties.
Mr. Slafsky directed and oversaw two national conferences that grew in size for 22 years straight, along with 10 regional roundtables per year that brought together the various stakeholders in the 340B program. Mr. Slafsky oversaw a team of government relations specialists, attorneys, policy analysts, writers and pharmacists who advocate on behalf of member hospitals and provide compliance guidance. Mr. Slafsky helped conceive and oversaw various communications resources including the widely-read blog 340B Informed and the member-only electronic news service–The Bulletin. He was the Co-Founder and Editor-in-Chief of the Drug Discount Monitor.
Prior to his time at 340B Health, Mr. Slafsky was a Health Policy Fellow for the U.S. Senate Democratic Policy Committee. He assisted Senate Majority Leader George Mitchell and Senate Democratic Policy Director Tom Daschle on messaging during the Clinton health reform debate. From 1990-1993, Mr. Slafsky was a Reporter and Researcher at U.S. News & World Report where he reported on politics, health and education policy. He also served as the editorial assistant to David Gergen, the magazine’s editor at large and advisor to four U.S. Presidents. Mr. Slafsky was the winner, with a team of U.S. News journalists, of the Overseas Press Club’s Hallie and Whit Burnett Award.
Mr. Slafsky has a Master of Public Policy from Duke University and Bachelor of Science in Political Science from Tufts University where he graduated Magna Cum Laude.
Ted lives in Northern Virginia with his wife Diane and two children.
Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication. McCaughan speaks frequently on regulatory, reimbursement and policy developments affecting the biopharmaceutical industry.
Prevision Policy, founded in 2010, provides health care policy analysis to advance the mutual understanding among policymakers, business executives and the investment community, in the belief that a deeper understanding of policy leads to better business, and a deeper understanding of business leads to better policy.
Peggy Tighe, JD
Principal Powers Pyles Sutter & Verville PC
Peggy Tighe deciphers and interprets highly complex healthcare matters and translates them into action. She teams with health systems, patient groups, and provider organizations to develop persuasive policy arguments and strategies to influence Congress and relevant agencies, creating change to protect and support providers and the patients they serve.
Peggy focuses her practice on lobbying, coalition building, crafting and implementing grass roots campaigns, and coordinating media relations. A dynamic and entertaining speaker, she is well versed on giving congressional and policy updates on subjects such as Affordable Care Act implementation, Medicare provider reimbursement including SGR reform, hospital wage index, nursing payments, Social Security disability, patient safety, medical liability reform, Long Term Acute Care Hospital and clinical laboratory policy, hunger and nutrition, and patient-focused pharmaceutical policy.
Peggy has spent her career understanding the complex policy problems that health systems, patient groups and provider organizations face, and influencing federal policy and decision making on their behalf. Peggy’s prior experience in healthcare lobbying and policy with two highly visible, national healthcare associations, the American Medical Association and the Health Insurance Association of America, as well as with dozens of national coalitions and individual clients, make her unique in this space.
Peggy has built and actively nurtures contacts and relationships on both sides of the political aisle, focusing her efforts on finding the right policy solution. She served as AMA’s lead lobbyist and primary contact with House Republican leadership, the House Energy and Commerce Committee, and some 80 Congressional assignments including the majority of physician members of Congress. She also works closely with the House Ways and Means committee, Senate Finance committee, and other relevant healthcare committees on both sides of the aisle.
Described by clients, Congressional staff, colleagues and contacts as “incredibly responsive” and “a team player”, Peggy devotes enormous effort to ensuring that clients never wonder about her activity and commitment, that members and their staff always have the tools and information they need to support their decision-making, and that her strong relationships on Capitol Hill result in direct benefits to clients. Yet, she’s never too busy to offer assistance, mentoring or guidance to her own team, Hill staffers, or other government relations professionals, as evidenced by her role as past President of Women in Government Relations, a non-partisan government relations association in the Washington metropolitan area and her award as Mentor of the Year from the Public Leadership Education Network.
Additionally, Peggy has:
Coordinated the activities of a hospital coalition that obtained more than $3 billion over a five-year period to implement beneficial changes to members’ Medicare area wage index classifications.
Led a coalition of five New Orleans area hospitals in the aftermath of Hurricane Katrina, securing hundreds of millions of dollars in federal funding to ensure that the hospitals were able to remain open and serve the community.
Effectively lobbied to persuade three U.S. Senators to break with their party on three occasions to vote in support of the AMA-backed Patients Bill of Rights in 1999.
Lead lobbyist for House victories on the Medicare Fee Schedule, Medical Liability Reform, Patients’ Bill of Rights, and Antitrust Relief, key issues of great importance to the medical community.
Directed and coordinated the activities of six field directors in the Health Insurance Association of America’s priority states during the successful "Harry and Louise" national healthcare reform campaign. Strategized and implemented many of the federal grassroots activities in this campaign, including grasstops (high-level grassroots), coalition building, letter writing, and database building.
APEXUS ADDRESS: 340B Trends, Hot Topics, and Solutions Supporting Compliance
Apexus, the HRSA-designated Prime Vendor for the 340B Drug Pricing Program, leads a 340B update on trends in the current environment. Hear the hot topics that manufacturers and entities ask the national call center, Apexus Answers. Also, gain insights on new and updated tools that support compliance and learn about opportunities to partner with other stakeholders to address 340B challenges for positive outcomes.
Review 340B trends and hot topics
Discuss new and updated tools that support compliance
Share solutions that involve partnership among stakeholders and address 340B challenges
Mike Benedict Vice President, Pharmacy Operations Apexus View Bio
Vice President, Pharmacy Operations Apexus
Mike Benedict is Vice President of Pharmacy Operations at Apexus, the organization responsible for managing the HRSA 340B Prime Vendor Program. Mike is responsible for managing relationships with suppliers, distributors and entities, and provides educational support for internal and external stakeholders to the 340B program.
Before joining Apexus, Mike was the Vice President of Health Enterprises Pharmacy Services where he developed services for member hospitals including: onsite and remote staffing services, 340B services, medication safety and revenue cycle consulting services. Additionally he has provided over 25 years of pharmacy leadership in areas as diverse as Disproportionate Share Hospitals, Critical Access Hospitals, Community Health Centers, School Based Clinics, Jails, Colleges of Pharmacy, Ambulatory Pharmacy and Clinical Services Management.
Mike received his Bachelor’s degree in Pharmacy from The Ohio State University. He completed residencies in Hospital Pharmacy and Hospital Pharmacy Administration at Mount Carmel Medical Center and completed in a Master’s degree in Hospital Pharmacy Administration at The Ohio State University.
Drive 340B Program Integrity – The Importance of an Engaged 340B Oversight Committee and Internal Monitoring Data
A key component of the 340B program is program compliance and integrity. Covered entities must agree to comply with all 340B statutes, policies, and guidance to maintain the integrity of its 340B program. Hear how an engaged 340B Oversite Committee, along with the use of internal monitoring data can help a covered entity achieve this goal of program integrity through best practices and required elements.
Identify the key stakeholders of the 340B Oversight Committee and describe the expectations for each member and the committee
Examine the internal monitoring procedures that align with the HRSA’s required elements and best practices
Better understand how the Oversight Committee utilizes the internal monitoring data to drive program integrity
Jason Mills, PharmD, ACE Senior Consultant Comprehensive Pharmacy Services View Bio
Jason Mills, PharmD, ACE
Senior Consultant Comprehensive Pharmacy Services
Jason Mills has served as a senior 340B consultant for Comprehensive Pharmacy Services (CPS), a leading pharmacy and 340B solutions company, since early 2020. CPS’ 340B expert team has been at it since 1992, when the 340B Drug Pricing Program launched. We’ve worked in covered entities and are experienced with all types of 340B programs, including large health systems, DSH, CAH, FQHCs, Ryan White and Hemophilia programs. Jason has been involved with the 340B program since 2005.
Before joining CPS, Jason helped manage a disproportionate share hospital’s 340B program for 11 years. He also has worked with Critical Access Hospitals and Sole Community Hospitals as a consultant for 9 years. Jason received his bachelor’s degree in biology from West Texas A&M University. He then received Doctor of Pharmacy degree from Texas Tech University Health Sciences Center.
How CEs and Manufacturers Can Better Support Each Other to Ensure Partnerships of Mutual Benefit
In the current climate, where the relationships between CEs and Manufacturers may feel more strained than ever, it’s also more important than ever to find ways to increase collaboration, streamline communication, and better address each other’s needs – particularly in realm of data sharing. Gain insights from both the CE and manufacturer perspectives as we look at the realities – and the optics – to find common ground on requests and responses from each side to ensure program integrity and drive towards a more sustainable 340B Program, where the central focus remains on serving a vulnerable patient population.
Noreen A Palinkas Director, Pharmacy Compliance Boston Medical Center View Bio
Mujeeb Rafiuddin 340B National Account Manager Genentech View Bio
Noreen A Palinkas
Noreen A Palinkas
Director, Pharmacy Compliance Boston Medical Center
Noreen Palinkas is an experienced compliance professional with a focus on healthcare, pharmacy, and government programs. Notably, she has spent over a decade within the 340B program. Noreen currently serves as the Director of Pharmacy Compliance for Boston Medical Center Health System, the primary teaching affiliate for Boston University School of Medicine and the largest Safety Net Hospital in New England. In this role, she has built a robust compliance program, including the introduction of numerous audit processes and increased data integrity standards across the hospital’s mixed use, retail, and community pharmacy settings. Ms. Palinkas has presented, multiple times, at 340B Coalition Conferences on the topic of Compliance and Navigating HRSA Audits. Noreen has also spoken at the Medicaid Drug Rebate Program conference, discussing the ongoing relationships between Covered Entities and Manufacturers. Beyond 340B oversight, Ms. Palinkas has developed audit procedures for Medicare billing compliance, Narcotics Diversion recognition, and maintains various REMS documentation programs for the BMC Pharmacy organization. Prior to her tenure at Boston Medical Center, Noreen spent 15 years with Walgreen Co., seven of these on the rebuilding of their 340B program.
340B National Account Manager Genentech
Mujeeb is a 340B National Account Manager with Genentech (A Member of the Roche Group) and has been in a variety of roles over the past 15 years with the company. Genentech is supportive of the appropriate use of the 340B program to support access to medicines for vulnerable patient populations. To help ensure the long-term sustainability of the Program, he is responsible for managing Genentech’s relationship with 340B hospitals/covered entities and focuses on Program integrity and compliance. Mujeeb’s work includes recovery of ineligible discounts through the informal dispute resolution process, managing self-disclosure letters, and 340B education both internally and external to Genentech.