The 340B Coalition Winter Conference takes place at a pivotal moment in the 25-year history of the 340B drug discount program. As attendees gather in San Diego February 21-23, this is just a sampling of the issues that will confront 340B stakeholders:
Legislative activity – The chairman of the House committee with jurisdiction over the 340B program has announced that Congress will begin taking action on the 340B program by this March. New bills have been introduced in both the House and Senate that would dramatically alter 340B, including scaling back hospital participation, reducing the number of sites eligible for discounts and adding new reporting requirements. More legislation is expected to be introduced shortly. This comes on the heels of a House committee releasing a report calling for significant program changes.
On the other hand, bipartisan legislation to block dramatic Medicare Part B cuts to 340B hospitals has been introduced and has rapidly picked up support from 179 Democrats and Republicans. All of this occurs with the backdrop of impending midterm elections that could reshape Congress.
A dramatic Medicare drug reimbursement cut for hospitals – 340B stakeholders are grappling with the fallout from the CMS decision to slash Medicare Part B drug reimbursement for hundreds of hospitals. Hospitals are fighting the cuts in court and on Capitol Hill, but the end result is far from certain. A group of hospitals and associations have challenged the regulations in court, saying they violate Medicare and 340B statutes. A key White House official was quoted saying that “the 340B program is really screwed up” and “has grown far beyond its intent.”
There’s also the related matter of hospitals having to identify which Part B drugs are purchased through 340B, which went into effect Jan. 1. Reconfiguring and evaluating software system changes to comply with the new mandate have proven to be operationally challenging and expensive.
New Regulations – There’s still great uncertainty about 340B program regulations. Enforcement of a long-delayed final regulation to set standards and methodology for the calculation of 340B ceiling prices and to create a system of civil monetary penalties for drug manufacturers that knowingly and intentionally overcharge for 340B covered outpatient drugs has been put off again, to July 1, 2018. The Trump Administration has indicated it intends to engage in additional rulemaking on the subject, and a new proposed rule is now under review at the White House Office of Management and Budget. Will the proposed rule significantly change the final rule? What will become of the final rule’s penny pricing policy? There is still no word on when the Health Resources and Services Administration will launch a related secure website to let healthcare providers check for the first time whether they are being charged the right prices for 340B covered outpatient drugs.
High drug prices – The press has reported that the President might issue an executive order on drug prices, which could include language addressing the 340B program, but the status of such an executive order is unclear.
Government studies – The Government Accountability Office has been working for almost a year on a study about 340B contract pharmacies and it could be released prior to the conference. The U.S. Department of Health and Human Services Office of the Inspector General, meanwhile, is working on an analysis of how much Medicare could save if drug companies paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.
Whether you are a health care provider, contract pharmacy, pharmaceutical manufacturer, 340B-oriented business or government agency, attending the conference is the best way to be informed about 340B.
We look forward to seeing you in February!
Mr. Donald Jones
Chief Digital Officer at Scripps Translational Science Institute, Cardiff Ocean Group Chairman
Donald Jones is a globally recognized leader in Digital Medicine (sometimes referred to as Wireless Health, Digital Health, Connected Health, or mHealth). He is sought out as a speaker, advisor and board member. He works with healthcare, pharmaceutical and medical device, OEM, Telcos and early stage companies. Donald Jones is the CEO of Trial Fusion, a company focused on commercializing digital health products by providing design and partnership expert advise and clinical, user experience and economic evidence required for their adoption. Jones also serves as the Chief Digital Officer of the Scripps Translational Science Institute, working with the renowned Eric Topol, MD, on the convergence of genomics and wireless health – digital medicine. He co-founded Scripps Digital Medicine, the world’s first clinical trial center focused on digital health and large data sets. For 11 years through 2014, he led Wireless Health Global Strategy and Business Development for Qualcomm. He is Founder and Chairman of the Wireless Life Sciences Alliance. Working with the XPRIZE Foundation and Qualcomm’s CEO, Jones conceived the $10 million Qualcomm Tricorder XPRIZE, a global competition for a consumer device which makes medical diagnoses. CommNexus recognized Donald Jones as 2014 Digital Health Innovator of the Year.
Who Should Attend
- Pharmacists and clinic directors at institutions providing care to low-income and uninsured populations
- Pharmaceutical manufacturers, distributors, and group purchasing organizations
- Pharmacy service companies and information technology firms
- Retail, chain, specialty pharmacies, and other businesses that contract with 340B entities
- State Medicaid pharmacy directors and drug assistance program managers
- Pharmacy benefit managers/administrators, and other health plans
- Consultants, attorneys, and other compliance experts
- Federal, state, and local policy makers and government relations directors
- AIDS drug assistance program officials and AIDS service organizations
- Other providers of health care for the uninsured and vulnerable populations
Continuing Education Credits for Pharmacists and Pharmacy Technicians Available!
Don't miss out! This is a great chance for all pharmacy service companies, pharmaceutical manufacturers, health insurance plans, IT companies, wholesalers, GPOs, and law/consulting firms to promote your company's services and products in an intimate and relaxed setting. Hundreds of pharmacists and other clinicians, hospital and health center executives, federal, state and local government officials, GPO's, wholesalers, drug company decision makers and other leading health care professionals will be attending this conference. The exhibit area is designed to ensure a high level of traffic that will enable your company to maximize its marketing investment. There are many exciting exhibition options as well as opportunities to promote your services on our website. More information on becoming an exhibitor will be available later this fall, but in the meantime, please contact Lee-Anne Gabrielli at (202) 552-5856 if you have any questions.
22nd Annual 340B Coalition Summer Conference
Call for Speakers Open
The 22nd Annual 340B Coalition Summer Conference will be held at the Omni Shoreham Hotel in Washington, DC on July 9-11, 2018.
Please check www.340bsummerconference.org for more information or sign up for our conference notification list below to be notified about all 340B Coalition conferences.
If you would like to be notified of future conferences on the 340B program, please create an account to be added to our mailing list. Please note that previous attendees at events hosted by The 340B Coalition or 340B Health, 340B Health members/corporate partners, and subscribers to 340B Informed do not need to sign up.