Welcome to the December edition of RxStrategies’ 340B Insider, a concise communication to provide a quick highlight of updates from RxStrategies’ view. Visit our website to read more.
340B INDUSTRY NEWS
THE U.S. HOUSE PASSES BILL TO KEEP DRUG COMPANIES FROM OVERCHARGING MEDICAID
The bipartisan bill, from Senators Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), comes after the Department of Health and Human Services last year accused Mylan, the maker of EpiPen, of overcharging the Medicaid program by as much as $1.27 billion over ten years by misclassifying the drug as a generic.
The Grassley and Wyden bill would give the Department of Health and Human Services new authority to reclassify a drug and recoup rebates when a manufacturer deliberately misclassifies a drug in order to pay lower rebates.
MANUFACTURER TRANSPARENCY RULE EFFECTIVE JAN. 1
Regulations designed to increase transparency and accountability for 340B drug manufacturers will take effect on Jan. 1 after the federal government finalized a proposal making official the effective date.
HHS on Nov. 29 issued a final rule moving up the effective date of the regulation to impose civil monetary penalties on drug companies that “knowingly and intentionally” overcharge hospitals for their 340B drugs.
UPCOMING 340B PROGRAM REGISTRATION REMINDER
Registration will be open Jan. 1 – 15, 2019
CEs must recertify their eligibility every year and notify the Office of Pharmacy Affairs whenever there is a change in their eligibility.
The registration component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) is now available here: https://340bopais.hrsa.gov
Please work with your Account Manager to assess Contract Pharmacy network expansion opportunities and support your 340B program goals.
MEDICARE 340B CUTS WILL CONTINUE AND EXPAND IN 2019
Medicare cuts of nearly 30 percent to certain 340B hospitals will continue into 2019, and the number of hospital sites affected will increase, under a final government rule issued Nov. 2 by the Centers for Medicare & Medicaid Services (CMS). 340B Health and our members joined with other hospital groups to oppose these policies.
- CMS finalized its plans to continue reducing payment to certain 340B hospitals for separately payable Part B drugs.
- Beginning Jan. 1, 2019, the agency also will expand the scope of those cuts to include non-excepted off-campus hospital outpatient departments (HOPDs), also known as “site-neutral” clinics.
- Critical access hospitals, sole community hospitals, children’s hospitals and cancer hospitals will continue to be exempt from the Medicare pay cuts.
RxStrategies believes likely legislative action around 340B in 2019 may include:
- A formal requirement for each participating 340B program hospital to disclose how any/all 340B savings are being reinvested into local communities. CEs should be working to document and summarize in their own form now, in advance of formal questions and/or requirements.
- Continued push from various states to formally require the inclusion of a “20” marker and submission on any MCO claims processed through 340B program. RxS’s real-time Contract Pharmacy processing solution can be helpful in this regard.
- Continued legislative pressure to refine portions of 340B program patient definition.
As a 340B Health Corporate Partner, we are focused to assist CEs in their advocacy efforts to protect and preserve the 340B program.
RxStrategies recommends continued proactive CE involvement in the 340B support process. Our 340B program experts are actively working with 340B Health to ensure Impact Profile and certain other CE templates are made available to our clients.
Contact your RxS account manager to discuss the following:
- 340B Health’s digital resources, including 340B Advocacy and Communications Toolkits
- How to complete 340B Health Impact Profiles and share your 340B stories.
- Discuss how RxS can support your advocacy efforts.
LET’S CONNECT AT THE 340B COALITION WINTER CONFERENCE
RxStrategies is pleased to be a Pinnacle Sponsor for the 15th Annual 340B Coalition Winter Conference, being held in San Diego, CA, Jan. 30 – Feb. 1.
Let’s Connect: Our team will be connecting with industry leaders to gain insight and discuss the latest 340B legislative updates and emerging market issues.
Meet the RxS Team: Stop by booth #201 or contact us to schedule an appointment.
Schedule a Demo: Contact Krista Scanlon to schedule a demo of our Dashboard Analytics tools that support a compliant 340B program.
Attend a Session with an Expert: Join RxS presenter – Rhodie Smith, VP of Contract Pharmacy Sales, on January 31 for Breakfast: 340B Lessons from the Field.
Unable to attend? Send questions we can raise on your behalf by contacting your Account Manager.
CALENDAR OF EVENTS
Join the RxS team at the following conferences:
340B Coalition Winter Conference
Jan. 30 – Feb. 1 | San Diego, CA
NACHC Policy & Issues Forum
Mar. 27 – 30 | Washington, D.C.
WISHING YOU A JOYOUS HOLIDAY SEASON
From the entire RxStrategies team, we wish you Merry Christmas, a Happy Holiday Season and all the best in 2019!