After Nine Months, an Update on NIH’s Long Covid Research

3 min
December 22, 2022
By Rachel Cohrs

Pandemic response gets a home at the White House

The White House has relied on a rotating cast of temporary czars to coordinate responses to public health threats from Covid-19, to mpox, to AIDS, to the bird flu. But if the government funding package passes, pandemic preparedness will have a permanent home at the White House.

The new White House Office of Pandemic Preparedness and Response Policy would have a director appointed by the president and up to 25 staff to coordinate and evaluate the nation’s readiness to respond to health threats.

The new office could also step on some existing toes in the administration, experts told me. Read more on what we know about the new office, and the important questions the Biden administration would have to answer.

After nine months, an update on NIH’s long Covid research

The leader of the NIH’s $1 billion long Covid research project offered a progress update to advisers this month, following patient frustrations this spring that the agency had moved at a glacial pace.

The RECOVER initiative’s two adult cohorts have hit 50% of their enrollment targets for patients with acute Covid infections, and 80% for post-acute infections, after nearly two years of working to sign people up. The total combined goal for enrollment is between 16,000 and 18,000 adults. Interim analysis is expected in “early 2023,” per slides that NIH presented.

And after a long wind-up, the agency expects to start clinical trials for treatments in the first six months of 2023 in five key symptom areas: immune dysregulation, cognitive dysfunction, autonomic dysfunction, sleep disorders, and fatigue and difficulty exercising. The trials are expected to test drugs, biologics, devices, and behavioral treatments.

Despite the progress, some patient groups are still unsatisfied with the initiative’s pacing. They’re also frustrated that additional funding for the project was included in the White House’s Covid-19 supplemental request and therefore spurned by Congress, and that the NIH, they say, has ignored patients’ suggestions. One eyebrow-raising criticism: the patient representatives helping with the study are required to sign restrictive non-disclosure agreements.

NIH officials said they would follow up on patient complaints, and said that the level of patient engagement in the RECOVER initiative is, for better or worse, pretty new for NIH.

“Maybe it shouldn’t be this way, but in some ways, this is new territory for these types of studies to be engaging” patients, NIH Acting Director Lawrence Tabak told advisors.

Insuring the insurers against higher drug costs

The PBM lobby met last month with White House budget officials to pitch ideas for helping health insurers handle the higher costs that are expected to hit when Medicare starts negotiating drug prices and covering more of seniors’ drug costs, my colleague John Wilkerson reports.

The policy recommendations are a sign that insurance companies are genuinely worried about losing money under the new law, according to Sean Dickson, health policy director at West Health Policy Center. The new law lowers drug costs for seniors, but it is expected to increase costs for insurers if seniors take more prescription drugs once the government covers a greater share of the cost.

As for what they’re asking — it relates to Medicare’s complicated formulas to limit how much insurers lose (or profit). PBMs, which manage drug formularies for insurers, want to tweak those formulas in light of the new changes, so that insurers ultimately bear a little less risk, and get paid a little more, to cover those extra costs.

The group, the Pharmaceutical Care Management Association, also told the White House that Medicare should avoid negotiating prices for drugs that are already steeply rebated.

An earlier version of this item misnamed PCMA. 

The Biden administration’s private equity data dump

One important development you may have missed in the omnibus fracas: The Biden administration on Tuesday released a massive spreadsheet with ownership data on more than 7,000 Medicare-certified hospitals in the country, my colleague Tara Bannow reports.

Once private equity buys into a hospital, it’s difficult to find out about it. Not only do such companies have lots of layers, they tend to separate hospitals’ operations from real estate, which adds to the complexity.

“It’s a huge first step in creating accountability for private equity firms,” said Eileen O’Grady, research director with the Private Equity Stakeholder Project, a not-for-profit watchdog group.

Read the full story here, and as usual, if you catch any interesting tidbits in your own scan of the database, please pass them along!




Sean Dickson
Director, Health Policy