Editor's Note: This is part two of a two-part series. Read part one here.
4. HRSA Never Stops Auditing 340B Grantees - Even in a Pandemic
While we’re all aware health center facilities operated in an unprecedented environment, some also were subject to intensive audits on top of battling COVID. At the beginning of December 2020, HRSA had completed 188 audits over the course of the year—proof that despite a pandemic and the immense challenges it places on all of US healthcare, HRSA is dedicated to protecting the integrity of the 340B Drug Pricing Program.
Of the 188, 144 audit results posted listed no corrective action necessary. 38 had to make repayment to drug manufacturers, and five had to terminate relationships with contract pharmacies or offsite outpatient facilities.
5. Health Centers Are Eager to Learn and Share What Works
par8o is proud to sponsor both national organizations that continually support and educate health center staff: the National Association of Community Health Centers (NACHC) and the 340B Coalition.
Each month, NACHC hosts various webinars and virtual “office hours” where health center operational staff can join and ask questions, learn from others, and generally stay informed. A closed message board named Noodlepod is available to all health centers; 340B Coalition has one as well named The Exchange.
Sometimes, our staff joins the monthly NACHC office hours calls to listen and learn from you all, and we highly encourage all health centers to join in if possible. The continual dedication to learn and implement new strategies is what enabled health centers to pivot operations in a pandemic so quickly - see item one in this series for some details.
This appetite for doing what works is seen across the board, from the involvement in state primary care associations or community health conferences to those who join in on our own educational webinars.
6. Justice for Health Centers Looks Promising: HHS (Finally) Issued Guidance In Favor of Contract Pharmacies at the End of 2020
In the spirit of education, par8o also hosts free educational webinars once per quarter to support and educate those interested in learning how to compliantly capture referral prescriptions for 340B pricing. The live Q&A was so educational that we decided to host referral capture office hours, starting in March 2021 - be sure to subscribe to our blog to be notified when we launch. (If interested, you can watch the webinar/Q&A here.)
Despite July statements that said HRSA had no legal authority to mediate the contract pharmacy situation, after repeated requests from many state attorney generals and 340B covered entities, the Department of Health and Human Services General Counsel published formal guidance on the matter at the end of December in no uncertain terms:
HHS General Counsel Robert Charrow concluded, often in strong and colorful language, that the 340B statute requires manufacturers to offer their products for purchase by covered entities at or below the 340B ceiling price, “not qualified, restricted, or dependent on how the covered entity chooses to distribute the covered outpatient drugs.”
“The situs of delivery, be it the lunar surface, low-earth orbit, or a neighborhood pharmacy, is irrelevant,” Charrow wrote.
“Certain manufacturers’ newfound and unilateral refusal to sell drugs through contract pharmacies is at odds with the structure and intended operation of the statute,” he said.
Justice may look promising, but the battle is sure to continue. Our bet is on the health centers - read our predictions here.
In closing, 2020 was unpredictable at best. But by the end of 2020, we saw that the “little guy” is likely to win the fight when regulatory loopholes allow for unwelcome changes; HRSA is unceasingly dedicated to fairness and equality in its 340B Drug Pricing Program, and, as always, scrappiness, a positive attitude and the ability to adapt and change are keys to success and survival, whether it be a pandemic, or consistently operating with constant funding shortages. Health centers and 340B Program Grantees, we salute your fortitude!