Introducing Biden's NIH pick

The ideas and innovators shaping health care
May 15, 2023 View in browser
 
Future Pulse

By Erin Schumaker, Ben Leonard and Ruth Reader

WASHINGTON WATCH

Monica Bertagnolli speaks in a chair.

Bertagnolli is Biden's pick to lead NIH into the post-pandemic world. | Pool photo by Jeff Chiu

Monica Bertagnolli is President Joe Biden’s choice to shepherd the National Institutes of Health into a world in which Covid is no longer a public health emergency and, in so doing, restore faith in science damaged during the pandemic.

If the Senate confirms her, the Boston cancer surgeon and head of the National Cancer Institute will oversee a $45 billion budget.

It’s a complex job by definition. But in an era in which even a research-focused agency that's traditionally enjoyed bipartisan congressional support is politicized, the challenge isn't strictly scientific or administrative — it's existential.

Bertagnolli has the support of the scientific community — including Anthony Fauci, the former head of the National Institute of Allergy and Infectious Disease. “I was one of the ones that strongly suggested that she be considered for the director of NIH,” Fauci told Erin.

Meet Bertagnolli: 

– She was chief of surgical oncology at Dana-Farber Brigham Cancer Center, and led both the Alliance for Clinical Trials in Oncology and the American Society of Clinical Oncology before the NCI job.

– Widely regarded as unflappable and a good listener, Bertagnolli, 64, took on challenging surgical cases that other doctors passed on.

– She hails from Wyoming, which could lend her credibility with congressional Republicans.

– Last year, she was diagnosed with early-stage breast cancer and is still undergoing treatment. “It’s one thing to know about cancer as a physician, but it is another to experience it firsthand,” she wrote at the time.

Bertagnolli may face contentious confirmation hearings:

— Republican lawmakers, who are investigating the NIH, are expected to grill her on the origins of Covid and on their theory that NIH research grants helped cause the pandemic.

— Across the aisle, Bernie Sanders’ (I-Vt.), who chairs the Senate Health, Education, Labor and Pensions Committee, recently warned Biden that he would oppose "any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs."

It's a high-stakes challenge, especially for someone who has only logged seven months in Washington.

Bertagnolli is up for the task, said Fauci: “I don’t think she’ll have trouble handling that.” As a surgeon, “You have somebody’s life in your hands, almost on a daily basis — that’s a high-pressure situation.”

 

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WELCOME TO FUTURE PULSE

Chesapeake Bay Maritime Museum, St. Michaels, Md.

Chesapeake Bay Maritime Museum, St. Michaels, Md. | Shawn Zeller

This is where we explore the ideas and innovators shaping health care.

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The bear crawl, crab walk and bunny hop require little or no equipment, build strength and flexibility, and help combat the effects of sitting for long periods, fitness instructors told The Journal.

Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com.

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Today on our Pulse Check podcast, host Katherine Ellen Foley talks with Robert King about some House Republicans' concern that a cost-cutting proposal from the Center for Medicare and Medicaid Innovation to reduce payments for drugs that have won FDA approval but haven’t yet proven their clinical benefit would curtail innovation.

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CHECKUP

This photo taken Jan. 30, 2013 shows adult nurse practitioner Jayne Mitchell watching at right as patient Marlena Bechtel-Rysdam, from Elgin, Ore., practices using an electronic monitoring device called a Health Buddy, at Oregon Health Sciences University in Portland, Ore. Hospitals are under new pressure from Medicare to slow a pricey revolving door _ the number of people who are rehospitalized only weeks after they left for   problems that could have been prevented. In Mitchell's program, patients with heart failure get extra education before they're discharged and some are tracked at home with special telemedicine monitors. (AP Photo/Don Ryan)

Medicare is tightening up on the remote patient monitoring it will pay for. | AP

The Covid emergency’s end last week will have an under-the-radar impact on remote patient monitoring.

Such monitoring was widely available via Medicare under eased pandemic rules.

Now, Medicare can pay only for devices used to track the vital signs of “established patients” — those who began using at-home health monitoring beforer the emergency’s end on May 11.

Why it matters: The pandemic accelerated the move toward care in the home, with remote monitoring playing a key role.

The technology, which can be used to monitor a wide variety of conditions, including high blood pressure and diabetes, has drawn significant private-sector investment.

A 2022 Medical Group Management Association survey found that about a quarter of health practices offered remote monitoring and about a quarter of those that didn’t said they’d mull doing so in the next year.

“Even before the pandemic, a growing evidence base has reinforced this technology’s ability to detect issues early and improve outcomes, reduce costs, augment population health management and alleviate staff burnout,” Brian Scarpelli, executive director of the Connected Health Initiative, a digital health group, told Ben.

What’s next: Scarpelli’s group is boosting its campaign to prove monitoring’s value. It’s creating a “central resource” to vet research and best practices that will launch in the next month with the aim of informing policy and the industry.

 

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INNOVATORS

A man uses the Pear Therapeutics reSET app on a phone.

A man uses the Pear Therapeutics reSET app on a phone. | Business Wire

As recently as January, Pear Therapeutics seemed to be on the cutting edge of health care with its products melding smartphones with addiction therapy.

But it all fell apart last month when the Boston firm said it was filing for bankruptcy and selling its assets: online apps, also known as prescription digital therapeutics, that the FDA has approved to help people addicted to opioids or other drugs.

Supporters say it’s Congress’ fault and symptomatic of a broader problem in Washington that holds back innovative treatments: the government’s reluctance to pay for them, Ruth and Ben reported in a feature piece for POLITICO.

“Pear filing for bankruptcy was a direct consequence of Congress’ failure to pass legislation,” said Kevin Brennan, a former Pear lobbyist.

Though Pear won FDA approval five years ago for its substance-use disorder apps, which provide courses on managing the disease and help patients track their cravings and keep up with in-person treatments, the Centers for Medicare and Medicaid Services can’t reimburse providers for them, partly because Congress hasn’t approved new billing codes that describe the therapy.

That has a broader effect on the market because many private insurers make coverage decisions based on what CMS does.

To the rescue? Sens. Jeanne Shaheen (D-N.H.) and Shelley Moore Capito (R-W.Va.) and Reps. Kevin Hern (R-Okla.) and Mike Thompson (D-Calif.) introduced legislation in March that would create coding and payment policies needed for CMS reimbursement.

Why it matters: The category is ill-defined, but it’s thought that the FDA has authorized three dozen digital therapeutics to treat chronic conditions, including ADHD, back pain, schizophrenia and insomnia.

There’s good cause to encourage this innovation, the companies say, given the limits of existing drug therapies.

Even so: Potential buyers say they want to see more data.

“We shouldn’t begin to change health systems and payment based on evidence that doesn’t exist yet,” said John Torous, director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston. “I don’t think we’ve seen anything at that level of robust evidence yet.”

 

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