Presented by

With David Lim

‘GREED’ — That’s a word you can expect to hear at today’s Senate HELP Committee hearing about Moderna’s Covid-19 vaccine price.

David reports that the committee chair, Sen. Bernie Sanders (I-Vt.), is expected to come out swinging, continuing his decadeslong campaign against what he says is the greed of the pharmaceutical industry.

“There’s really moral issues involved here, as well as economic issues,” Sanders told David. “The bottom line is that this greed has got to stop.”

Moderna’s response: CEO Stéphane Bancel is expected to defend the company’s plans to sharply raise the price of its Covid vaccine.

The company’s fulfilled obligations to the U.S. government through the pandemic may be a major point for Bancel, as will comparisons with the average cost of annual flu vaccines.

Bancel told POLITICO he fears the scrutiny will make companies less likely to jump into public-private partnerships in the future.

“We’re the only one being called to testify; I just hope it doesn’t send the wrong signal,” he said.

But that answer doesn’t satisfy some advocates. Peter Maybarduk, access to medicines director at liberal consumer advocacy group Public Citizen, says Bancel’s fear about fewer public-private partnerships is meritless and the company wouldn’t exist in its current form without the government support it received.

“If Moderna didn’t want scrutiny, it shouldn’t have proposed spiking its prices and been extraordinarily recalcitrant in its role in global Covid relief,” Maybarduk said.

WELCOME TO WEDNESDAY PULSE. How many steps have you taken so far today? Experts worry it may not be enough, with the average person taking 600 fewer steps than they did before the pandemic.

One way to get steps in: Find us on the Hill and tell us what you’re hearing. Drop us a line at [email protected] and [email protected].

TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with David Lim about what to expect during today’s Senate HELP hearing when Chair Bernie Sanders faces off with Moderna CEO Stéphane Bancel over the hefty cost the company plans to charge for its Covid-19 vaccine.

NOT ADDING UP — The CDC has a data collection problem when it comes to tracking Covid vaccinations — at least that’s what the Covid States Project, a collaboration of researchers from Northeastern, Harvard, Rutgers and Northwestern universities, says.

Krista reports on a new analysis from the group, which finds the CDC overcounts the number of vaccinated Americans — offering a distorted picture of the nation’s immunity levels and vaccine acceptance to citizens and policymakers as hundreds of people continue to die each day from the virus.

The CDC collects Covid vaccination data from states, which don’t reliably link multiple shots received by the same individual, according to the researchers.

One example? The CDC website says 6.45 million adults in Massachusetts have had at least one Covid-19 shot — even though fewer than 6.45 million adults live in Massachusetts.

“It’s a secret that’s out in the open,” said David Lazer, a professor at Northeastern University and the report’s lead author. The CDC isn’t trying to cover up its methodology, he said, adding that the agency acknowledges on its website that the problem can distort its data.

The CDC did not respond to requests for comment.

PROSTATE DRUG PETITION DENIED AGAIN — On Tuesday, the federal government rejected a petition asking the NIH to use so-called march-in rights to take ownership of patents tied to the pricey prostate cancer drug Xtandi, David reports.

Such rights have yet to be used, but their aim is to help lower prices for drugs developed using government funds.

HHS and the Department of Commerce will launch an interagency review of the government’s authorities under the Bayh-Dole Act, which grants the march-in rights.

The rejection, which affirms a similar 2016 determination, wasn’t well received by some Democrats on the Hill.

“I am extremely disappointed that the Biden Administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi,” Sanders said in a statement following the announcement. “This is a drug that was invented with taxpayer dollars … and can be purchased in Canada for one-fifth the U.S. price.”

That sentiment was shared by Rep. Lloyd Doggett (D-Texas), who said the “excessive price-gouging” cost taxpayers more than $2 billion in 2020.

It’s also a blow to liberal groups, including Public Citizen and Families USA, which argue that taking such a step would rapidly lower the price of Pfizer and Astellas Pharma’s prostate cancer drug.

“NIH’s analyses in response to the petition request have found Xtandi to be widely available to the public on the market,” wrote Lawrence Tabak, who is performing the duties of the NIH director. “In addition, given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

James Love, brother of one of the complainants and director of Knowledge Ecology International, a nongovernmental organization that focuses on intellectual property that has also petitioned NIH, lamented the decision, which he said has “no silver lining” and runs directly in contrast to the Biden administration’s executive order on drug prices.

FIRST IN PULSE: A BILL TO FORCE CMS’ HAND — A bipartisan bill reintroduced today would guarantee four years of Medicare coverage for “breakthrough” medical devices greenlit by the FDA, codifying a Trump-era policy that the Biden administration repealed in January 2021 over concerns about the applicability of certain devices to the Medicare population, David and Daniel report.

While the bill has not had much luck in previous sessions, there’s added pressure this year because CMS is working on a replacement policy to create an accelerated coverage pathway for medical devices, which means the lawmaker’s effort could pressure the agency into proposing a friendlier industry policy.

The Ensuring Patient Access to Critical Breakthrough Products Act — introduced by Suzan DelBene (D-Wash.) and Brad Wenstrup (R-Ohio) and notably cosponsored by House Energy and Commerce Health Subcommittee ranking member Anna Eshoo (D-Calif.) and chair Brett Guthrie (R-Ky.) — would direct CMS to cover such devices for four years.

“With potential administration rulemaking on ‘breakthrough’ products any day now, Congress must make clear where we stand,” DelBene said in a statement to Pulse. “With the bipartisan support of key members of the Ways & Means and Energy & Commerce committees, this legislation shows that CMS must provide sufficient coverage of these life-saving devices.”

Separately, CMS is developing a replacement policy to create an accelerated coverage pathway for medical devices. Tamara Syrek Jensen, director of the CMS coverage and analysis group, said last fall the agency plans to issue a proposed rule in April.

The medical device industry is heavily lobbying over the issue, arguing that the gap between a product’s approval and coverage delays patient access and deters research and development of new technologies.

CROSSING BORDERS — A new report finds that states allowing patients to seek telehealth care from outside their borders have received few complaints and haven’t taken disciplinary actions against those providers, POLITICO’s Ben Leonard reports.

The report from the Cicero Institute, an entrepreneurship-focused think tank in Austin, Texas, found that Florida officials have received 16 patient complaints since the state legislature approved cross-state telemedicine in 2019. And in Idaho, GOP Gov. Brad Little’s decision to allow cross-state telemedicine in 2020 has had virtually no pushback from patients in the form of formal complaints.

Through the pandemic, many states waived licensing rules and are now grappling with whether to continue those waivers. Many have already dropped the pandemic-era rules, resulting in a patchwork system across the country.

HHS Secretary Xavier Becerra supports continued cross-state practice and has asked Congress to facilitate it.

ACCESS FROM AMERISOURCEBERGEN? AmerisourceBergen, one of the nation’s biggest pharmaceutical wholesalers, is being condemned by Sen. Catherine Cortez Masto (D-Nev.) for, according to her, refusing to distribute abortion pills in her state, POLITICO’s Alice Miranda Ollstein reports.

The state’s senior U.S. senator said the Pennsylvania-based company’s government affairs and legal teams informed her staff Friday that Nevada is one of 29 states where it won’t supply pharmacies with Mifeprex, the brand name of the FDA-approved abortion drug mifepristone. The company will, however, continue to supply the drug directly to doctors.

AmerisourceBergen spokesperson Lauren Esposito declined to confirm or deny what the company said to Cortez Masto’s office, but she told POLITICO its goal is “maintaining access to medications where legally permissible.” She also noted that the definition of what is legal is “dynamic and rapidly evolving in individual states based on nuances in state laws and regulations that are under regular pressure from legal challenges.”

The Washington Post and the Markup report on the consequences of new liver transplant rules.

The Atlantic reports on the major clue about Covid’s origins that remains out of reach.

Vanity Fair reports on Ron DeSantis’ plan to ride anti-vaxxism to the White House.