Nearly all 340B-related program guidance documents have been taken down from an online database that the Trump administration launched last summer to underscore its position that federal government guidance documents are non-binding.
The U.S. Health Resources and Services Administration’s (HRSA) ability to enforce its 340B guidance—its 1996 and 2010 contract pharmacy guidance in particular—is central to four drug manufacturers’ lawsuits asking federal courts court to strike down the U.S. Health and Human Services Department (HHS) general counsel’s Dec. 30 advisory opinion that drug makers must provide 340B discounts when covered entities use contract pharmacies to dispense drugs. The four drug companies say the advisory opinion contradicts HRSA’s previous statements that its 340B guidance is non-binding.
The advisory opinion is one of just four guidance documents tagged with the keyword “340B” that remain in HHS’s Guidance Portal. There were 39 when the portal went live in July 2020, mostly copies of web pages on HRSA’s Office of Pharmacy Affairs (OPA) web site. Mixed in were a few Centers for Medicare & Medicaid Services (CMS) documents and one HHS Office of Inspector General (OIG) document that mentioned 340B.
That means, for now, there is just one HRSA 340B program guidance document in the database—the copy of its 340B program requirements webpage.
It is not known when the majority of the 340B guidance documents disappeared from the HHS portal, who took them down, or why. Their removal might be connected to President Joe Biden’s Jan. 20 revocation of an executive order that former President Donald Trump signed in October 2019. That order stated it was executive branch policy “to require that agencies treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract.” Trump’s order required all federal agencies to create online databases of all their guidance documents.
Trump’s order preceded several public statements HRSA made earlier last year that it is not pursuing new 340B program guidance and is evaluating its audit processes and other program integrity efforts. The reason, it said, is because the 340B program is administered primarily by guidance and guidance does not give HRSA adequate enforcement capability. HRSA has coupled such statements with appeals to Congress for authority to issue binding and what the agency believes to be enforceable regulations for all aspects of 340B.
We asked HRSA yesterday when the 35 guidance documents tagged 340B were removed from the HHS guidance portal, why they were removed, whether they are still in effect, and where they can be accessed now. Here is what HRSA said:
The web content you are asking about appears on the HHS.gov website. HRSA does not control this website.
All the guidance documents currently in effect for the 340B Program can be found at www.hrsa.gov/opa.
It referred all question about the HHS guidance portal to the department’s public affairs office.