By ADAM CANCRYN and SARAH OWERMOHLE
06/24/2021 10:00 AM EDT
With Rachel Roubein, Dan Goldberg, Susannah Luthi and David Lim
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— Now that the Affordable Care Act is safe from the courts, supporters want the Biden administration to get to work on long-overdue improvements.
— Conservative lawmakers want to block colleges from requiring students to get vaccinated, setting up contentious legal fights to come.
— A bipartisan group of lawmakers is launching another bid to overhaul how the FDA regulates certain tests and diagnostics.
WELCOME TO THURSDAY PULSE — where like any good public health campaign, New Jersey’s Twitter account knows what (extremely blunt) message its audience needs to hear. Tips to [email?protected] and [email?protected].
A message from PhRMA:
The way insurance covers your medicine is too complicated. See how we can make the system work for patients. Not the other way around.
WHAT COMES NEXT FOR THE ACA — Buoyed by Obamacare’s newfound safety, liberal health policy experts are pressing the Biden administration to patch longstanding holes in the law flaws they worry have pushed up claim denials and narrowed provider networks, POLITICO’s Susannah Luthi reports.
A report earlier this year found that insurers on the Obamacare markets denied an average of 17 percent of submitted medical claims in 2019, though that number ranged widely depending on the state. It’s a problem that advocates warn could worsen unless the government takes a harder line with insurers — and one they argue deserves more scrutiny, now that it’s clear the law is here to stay.
Among the options policy experts have proposed: an HHS audit of health plans’ claims denials and new standards that would ensure patients can see doctors without traveling too far or waiting too long.
There is also growing concern over the prices insurers are charging for their plans, with advocates pointing to the record-breaking rebates likely to be paid for a third straight year by companies that didn’t funnel at least 80 percent of customers’ premiums toward paying for medical claims.
And HHS has also committed to investigating whether insurers have been adding enough providers to their networks. But that won’t happen until next year. A spokesperson added the department is “always looking for ways to improve oversight” in the meantime, but offered few specifics.
THE BREWING RED-STATE VACCINE SHOWDOWN — An executive order in Arizona and a bill in Florida have banned universities from mandating that students show proof of their vaccination status before returning to campus. And a group of Indiana University students are suing over that school’s vaccine requirement.
It’s the latest partisan flashpoint in the pandemic, POLITICO’s Ben Leonard reports. As many as 16 states have imposed some form of ban on government vaccine mandates, disputes that could also hamper efforts to boost the nation’s overall vaccination rate as the Biden administration struggles to convince younger adults to get their shots.
The American College Health Association has backed the mandates, and most colleges have long required students to get other vaccines. But after Arizona State University rolled out its vaccination plan earlier this month, GOP Gov. Doug Ducey issued an executive order blocking its requirements.
Florida Gov. Ron DeSantis moved even faster, signing a ban on mandates at both private and public colleges and universities in May. The fight over IU is ongoing, though after state Attorney General Todd Rokita warned its planned mandate could violate the law, the school announced it would only require students to self-attest that they’d been vaccinated.
— Listen: On today’s POLITICO Dispatch, Adam goes deep into what’s driving the vaccination slowdown, and why the Biden administration is likely to miss its Independence Day goal of partially vaccinating 70 percent of all adults.
FIRST IN PULSE: LAWMAKERS BRING BACK MEDICAL TEST REGS OVERHAUL — A bipartisan, bicameral group is reintroducing tweaked legislation Thursday that would overhaul how the FDA oversees laboratory-developed tests and diagnostics, POLITICO’s David Lim reports.
The VALID Act would regulate both lab tests and diagnostics under a new framework clarifying the responsibilities of the FDA and CMS. Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are backing the bill in the House, with Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) sponsoring the Senate version.
“We can’t allow an outdated and inefficient system to hold us back when trying to respond to an emerging threat, such as the coronavirus,” DeGette said in a statement.
The effort follows scrutiny over how the government regulates medical tests, after the Trump-era HHS last year tried to limit the FDA’s oversight of certain tests developed and used by individual labs.
But it could take months for legislation to find its way to the floor. Multiple congressional aides told David that it’s more likely the bill would be included in FDA user fee reauthorizations that will come up in 2022.
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TODAY: DEMOCRATS READY HOME-CARE FUNDING BILL — Democrats will introduce bicameral legislation allocating federal funds toward home care for seniors and people with disabilities, a first step toward making good on Biden’s pledge to invest $400 billion in Medicaid’s home- and community-based services, POLITICO’s Rachel Roubein reports.
The pandemic has devastated nursing homes, accelerating efforts to rethink care for aging Americans. Under this bill, states would be eligible for enhanced federal funding for home care on the condition that they also put certain accountability and quality metrics in place. Other provisions would also aim to expand the home care workforce and offer older adults a wider range of services.
Sen. Bob Casey (D-Pa.), who chairs Congress’ aging committee, is introducing the bill alongside Rep. Debbie Dingell (D-Mich.). Several senior Democrats have already signed on, including Majority Leader Chuck Schumer, Senate Finance Chair Ron Wyden (D-Ore.) and House Energy and Commerce Chair Frank Pallone (D-N.J.).
SUPPORT GROWS FOR CLOSING MEDICAID’s COVERAGE GAP — More than 200 organizations across the dozen states that have yet to expand Medicaid are urging Congress to create a federal fix in its upcoming legislative package, Rachel reports.
“Congress has a brief window to act. Now is the time,” the health equity and racial justice groups wrote in a letter, dated today, to Biden and congressional leaders.
There’s a growing chorus of calls for a federal solution to extend health insurance in states that have refused to expand. Despite dangling new federal incentives, leaders in the mostly GOP-led holdout states haven’t budged, prompting health advocates to seek ways for Congress to guarantee coverage for roughly 2 million poor adults. But lawmakers have yet to settle on how to accomplish that, and any proposal could come with a steep price tag.
JUDGE RULES MISSOURI GOVERNOR CAN REFUSE MEDICAID EXPANSION — Republican Gov. Mike Parson will not have to expand Medicaid in Missouri under a state court’s ruling on Wednesday, even though voters already approved a constitutional amendment mandating that Missouri broaden its coverage under the program, POLITICO’s Dan Goldberg reports.
Cole County Circuit Judge Jon Beetem, an elected Republican, said the ballot measure to expand Medicaid was flawed because it did not instruct lawmakers on how to fund coverage for an estimated 275,000 more people. That decision jeopardizes the prospects for expansion in Missouri, since Republican lawmakers refused to set aside money to pay for the program. Supporters of the Medicaid expansion are planning to appeal the verdict.
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REGENERON EXEC: GOVERNMENT FAILED TO PROMOTE COVID THERAPIES — A better U.S. government communication strategy could have prevented “a very significant number” of deaths during the pandemic, Regeneron President George Yancopoulos said Wednesday at the Milken Institute Future of Health Summit.
Yancopoulos specifically criticized the government’s “collective failure” to promote antibody treatments for Covid-19, arguing that the administration should have spent more time telling people how they could get treated for infections.
Federal public health officials “were so focused on communicating the vaccine message that they did not do a very good job, or a job at all, of communicating that if you were already infected, if you were already sick, there was a treatment that could save your life,” he said.
Other pharma execs expressed hope that Covid-19 would change the industry for the better. The rapid development of Covid vaccines using genomic data is “a glimpse of the future,” Illumina CEO Francis deSouza said, adding that the next wave of vaccines could target cancer and malaria. Tempus founder Eric Lefkofsky similarly predicted that technological advances could allow scientists to eradicate most diseases within 50 years.
WALENSKY: COVID ISN’T DONE WITH US — CDC Director Rochelle Walensky stressed Wednesday that the U.S. still has plenty of work to do to beat the pandemic, even after weeks of progress.
In particular, she pointed to the rapid spread of the more transmissible Delta variant, as well as the slowing vaccine administration rate, — which has left “pockets of this country” vulnerable to new outbreaks. Walensky added that with shots now widely available, nearly every one of the 275 to 300 Covid-19 deaths per day in the U.S. “is an avoidable death.”
A message from PhRMA:
Getting to what you pay for medicines shouldn’t be a maze. Let’s make out-of-pocket costs transparent, predictable and affordable. And let’s do it without sacrificing access to medicines and innovation. See how we can make the system work for patients. Not the other way around.
In a Washington Post op-ed, three top FDA officials laid out their justification for approving the controversial Alzheimer’s drug Aduhelm.
A Seattle scientist has recovered copies of genetic sequences isolated from Covid-19 patients that were mysteriously deleted last year at the behest of scientists in Wuhan, China, BuzzFeed News’ Peter Aldhous and Dan Vergano report.
Blood banks are facing critical shortages for the first time since the early days of the pandemic, USA Today’s Taylor Avery reports.
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Adam Cancryn is a health care reporter for POLITICO Pro. Prior to joining POLITICO, he was a senior reporter for S&P Global Market Intelligence, covering the intersection of money, politics and regulation across the financial services and insurance industries. He’s also written for The Wall Street Journal and Dow Jones Newswires, and got his start at the Philadelphia Business Journal.
Adam is a graduate of Washington & Lee University and a proud New Jersey native.
Sarah Owermohle is a health care reporter for POLITICO Pro covering drug policy and the industry. Before joining POLITICO, she covered the business of health care for S&P Global Market Intelligence and spent five years in Dubai and Beirut reporting on business, finance and development in the Middle East and Africa, including a three-year stint as the editor of Banker Africa. She graduated from the College of William and Mary in Williamsburg, Va.
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