Today is President Biden’s 155th day in office, and he has yet to pick someone to run the U.S. Health Resources and Services Administration (HRSA), the federal agency responsible for the 340B drug pricing program.
This normally might be a handicap for HRSA, especially given that it is embroiled in multiple high-stakes lawsuits with drug manufacturers over 340B contract pharmacy. But highly competent temporary leadership at HRSA, plus the close attention 340B is getting from the White House and the U.S. Health and Human Services Department (HHS), makes the vacancy at the top of HRSA’s organizational chart less of a problem, a 17-year veteran of HRSA says.
“Ideally, there should be an administrator in place,” says Colleen Meiman, who worked at HRSA from 1998 to 2015. “But I’m less concerned about it than I normally would be, because I know HRSA’s two flagship programs—340B and the health centers program—are getting a lot of attention” from senior White House and HHS officials.
Meiman served at HRSA during Democratic and Republican presidencies and under three different administrators—Claude Earl Fox (Clinton administration), Elizabeth Duke (Bush administration), and Mary Wakefield (Obama administration). Now a senior policy adviser to state and regional primary care associations, she says she has “great confidence” in Acting HRSA Administrator Diana Espinosa, a career civil servant who has been HRSA Deputy Administrator since 2015. “She knows her stuff—she has ‘the mission thing,’ as I call it,” Meiman says. “And she knows how the government works.”
The HRSA administrator is a presidential appointee and does not require Senate confirmation. Compared with some other recent presidential administrations, this one has been slow to put its stamp on HRSA.
Fox, Clinton’s HRSA administrator, stayed on the job under Bush until April 2001, when he was replaced by Duke—who began on an acting basis, then was appointed to the job full-time in March 2002.
Obama appointed Wakefield to serve as HRSA administrator just 31 days into his first presidential term. Donald Trump named George Sigounas to lead HRSA on the 101st day of his presidency.
Staffing of the Biden administration got off to a slow start in part because the Trump administration contested the election outcome and did not cooperate with Biden’s transition team. During the 340B Coalition 2021 winter conference in February, Donna Shalala, Clinton’s HHS secretary, lamented the slow pace of getting Biden administration cabinet members and key officials approved by the U.S. Senate. She pointed out that she was approved one day after inauguration and already had a staff in place.
There has been virtually no chatter in Washington about whom Biden is considering for the HRSA job, or whom he is being urged to consider.
In April, 27 state medical associations and 13 national medical specialty societies sent a letter to Becerra and senior White House personnel directors promoting California pediatrician and state Sen. Richard Pan (D) for the HRSA slot. Pan chairs the state Senate Health Committee. Before his election to the state Assembly in 2010, he was an associate professor of pediatrics at the University of California at Davis and director of the UC Davis Children’s Hospital pediatric residency program.
Wakefield served on the Biden transition team, and is currently counselor to HHS Secretary Becerra on the issue of minors arriving in the U.S. unaccompanied by their parents or other adults. There has been no sign of Wakefield returning to HRSA.
Meiman says the Biden administration might wait to fill the HRSA post until after it fills two other higher profile slots at HHS—Food and Drug Administration commissioner, and director of White House Office of National Drug Control Policy (aka drug czar).
The ideal HRSA administrator “needs to have a bright and fast policy mind and needs to believe in the mission of health equity and ensuring access to care,” Meiman said. One of the administrator’s most important jobs, she said, is simply to ensure that the White House and HHS are aware of HRSA programs’ perspectives and needs. Prior experience working in the federal government is valuable but not necessary, she says, as long as the administrator “has some public sector experience and understands the processes and limitations of public sector policymaking.”
Finally, Meiman says it is important for a HRSA administrator to be able to hold his or her own in contests with “HHS’s 800-pound gorilla”—the Centers for Medicare & Medicaid Services. “CMS and HRSA have completely different perspectives,” Meiman says. “CMS ultimately is an insurance program. HRSA ultimately is about underserved patients.”
Whomever is chosen to lead HRSA will need to decide what to do about the agency reorganization that ex-administrator Tom Engels announced to HRSA’s staff less than a week before the change in presidential administrations.
The reshuffle was published in the Federal Register on Jan. 21 and has not been withdrawn by the Biden administration. None of Engels’ changes appear to have been implemented, however. HRSA’s organization chart was last updated online in February 2021, and it does not reflect the new plan.
The 340B program is housed within HRSA’s Office of Pharmacy Affairs (OPA), which in turn comes under HRSA’s Healthcare Systems Bureau (HSB). Under Engels’ reorganization, HBS was supposed to have been abolished. OPA was supposed to have been moved into a new Office of Special Health Initiatives (OSHI) within the Office of the HRSA Administrator. Rear Adm. Krista Pedley, OPA’s longtime director, was slated to be put in charge of OSHI, which would have included OPA plus HRSA’s vaccine injury compensation, global health, oral health, and behavioral health programs.
When the reorganization was announced, individuals knowledgeable about HRSA’s internal affairs told 340B Report the new administration was not expected to disturb it, at least not immediately, and they expected that the job of OPA director would be posted on the federal USA Jobs website.