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By SARAH OWERMOHLE and ADAM CANCRYN
With Alice Miranda Ollstein and Megan R. Wilson
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— Biden officials say it would take billions of dollars to provide free Covid tests as public health experts pan their reimbursement plan.
— A tale of two drug pricing reports: House Democrats and Republicans both issue reports today amid the Senate’s debate over Biden’s Build Back Better agenda.
— Labor and patient groups are slamming the latest surprise billing suit, saying the complaint from hospital groups should be dismissed.
WELCOME TO FRIDAY PULSE — From telehealth to mRNA (and cocktails-to-go), the pandemic has fundamentally changed our lives: Some highlights from our newsroom. What sticks out to you? Send thoughts and tips to [email protected] and [email protected].
A message from PhRMA:
At a time when the science has never been more promising, the Democrats’ latest drug pricing scheme puts patients in harm’s way by threatening future treatments and cures. Learn more.
WHY FREE COVID TESTS FOR ALL WON’T HAPPEN — The Biden administration opted for a controversial plan to pay for at-home Covid-19 testing through private insurance after officials concluded it would be too costly and inefficient to simply send the tests to all Americans for free, three administration officials told Adam and David Lim.
The decision to forgo a European-style approach to testing — which hinges on the government buying and widely distributing rapid tests — has sparked days of backlash, putting the White House on the defensive over its newest plan for containing the virus.
The cost of regularly sending all Americans at-home tests could quickly skyrocket and become unsustainable, officials said, pointing to the nearly $50 billion “test and trace” program that the U.K. put in place for a country that’s one-fifth the size.
Public health experts have panned the administration’s approach as too complex, zeroing in on a proposal that would require people to submit testing expenses to their insurer for reimbursement. The White House has sought to salvage the rollout, emphasizing its broader efforts to make Covid-19 tests freely available in hospitals, doctor’s offices and community centers.
Congress did allocate roughly $48 billion earlier this year for Covid-19 testing. But only $9.4 billion remains uncommitted, and there are plans to spend that amount in the coming months, an HHS spokesperson said.
That means the White House would need to go back to lawmakers for more money to fund any tests-for-all system, effectively ruling out quick action and threatening to bog the administration down in another partisan funding fight.
Another problem: Just 13 companies are authorized to sell over-the-counter tests in the U.S., though many more are still waiting to get green-lighted by the FDA. Even amid fears of a Covid-19 resurgence, Biden officials fretted that intervening now would stifle competition and discourage newer test makers from scaling up their manufacturing.
“It would’ve capped the market and not done anything to drive prices down,” a senior administration official said.
LAWMAKERS UNVEIL COMPETING DRUG PRICING REPORTS — House Democrats and Republicans are rolling out different recommendations this morning for lowering prescription drugs costs as the debate over the social spending bill and its health provisions drags on, Alice and Megan report.
Democrats will release their report — the result of a nearly three-year investigation based on stacks of internal documents from pharmaceutical companies — at a press conference Friday morning attended by party leaders, including Speaker Nancy Pelosi.
The report is aimed at “building the case for urgently passing the Build Back Better Act,” House Oversight Chair Carolyn Maloney said ahead of its release. “The House did its job. Now it’s time for the Senate to do the same.”
While Senate Democratic leaders have pledged to pass the bill before leaving Washington for Christmas, Sen. Joe Manchin has remained skeptical of that timeline. More meetings with the parliamentarian that could threaten some of Democrats’ top drug pricing provisions in the bill will continue next week.
Republicans plan to roll out a rival report claiming that pharmacy benefit managers, not drugmakers themselves, are to blame for rising costs. The caucus will propose several possible reforms, some of which Democrats support, too. But the biggest threat to PBMs — a measure eliminating rebates — would be repealed in the current BBB text.
SURPRISE BILLING BATTLE HEATS UP — The Coalition Against Surprise Medical Billing slammed a new lawsuit led by the American Hospital Association and the American Medical Association against a key portion of portion of the law meant to stop patients from receiving surprise medical bills, which takes effect on Jan. 1, Megan reports.
The pair of powerful industry groups filed suit on Thursday morning and argue that the Biden administration went too far when it wrote the provisions governing how to resolve a dispute when providers and insurers cannot agree on a fee. It’s the third such lawsuit filed by providers against the implementation of the No Surprises Act.
“This 11th-hour legal challenge by hospital and physician lobbies to block vital patient protections against surprise medical bills should be dismissed outright. It’s a desperate and misguided attempt to weaken the historic safeguards of the No Surprises Act," said a spokesperson for the Coalition Against Surprise Medical Billing, which includes industry, union and patient groups. "Patients have waited far too long for these common-sense policies. There should be no delay in making them a reality.”
The newest lawsuit seeks to suspend part of an interim final rule that favors a single metric during the independent dispute resolution over out-of-network bills — which the groups argue would still allow independent arbitration to move forward, just with the consideration of multiple factors.
A message from PhRMA:
HEALTH TARIFFS AT A CROSSROADS — U.S. Trade Representative Katherine Tai said Thursday that she is concerned that cutting tariffs on health care goods in response to the coronavirus pandemic could exacerbate some of the supply chain problems the United States has recently experienced.
There could be some role for cutting tariffs to better prepare for future pandemics, Tai said during a U.S. Chamber of Commerce event on U.S.-EU economic relations, when asked why the U.S. hasn’t joined the "Ottawa Group" health care initiative at the World Trade Organization led by Canada and the EU.
"But I think that we have pursued a really unfettered liberalization policy for the past many years and decades, and it is part of what has brought us to this current reality of very, very fragile supply chains," Tai said.
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DEMS PUSH BIDEN TO PREVENT MEDICARE PREMIUM HIKES — A group of Democratic senators led by Maggie Hassan (D-N.H.) wrote to President Joe Biden Friday asking him to take executive action to prevent Medicare Part B premiums from jumping nearly 15 percent in January — the largest increase in Medicare’s more than half-century history.
The lawmakers’ letter, first shared with Alice, says that if executive action isn’t possible, Biden should “work with Congress to develop a legislative solution.”
“Seniors cannot afford these increased health care costs,” the senators wrote, noting that many Medicare beneficiaries live on fixed incomes.
FDA AUTHORIZES TEEN BOOSTERS — FDA on Thursday authorized a booster dose of the Pfizer-BioNTech Covid-19 vaccine for 16- and 17-year-olds, giving those teens access to the shots as the Omicron variant spreads worldwide.
The decision comes just over a week after the companies first sought the expansion of their emergency use authorization for the vaccine as a booster. Eligible teens will be able to get the shot once they are at least six months past their second dose.
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STATE COURT: TEXAS ABORTION BAN UNCONSTITUTIONAL — State District Judge David Peeples ruled Thursday night that Texas’ six-week abortion ban is unconstitutional, but it wasn’t immediately clear how the decision will impact enforcement of the law and the availability of the procedure going forward, Alice reports.
Texas Right to Life, the state’s leading anti-abortion-rights group, has pledged to appeal the ruling. And a decision from the U.S. Supreme Court is still pending on whether to allow other legal challenges from abortion clinics in the state and the Biden administration to move forward. The abortion ban has been been in effect since Sept. 1
In his ruling, Peeples focused on the unique enforcement mechanism of the Texas law, which allows regular citizens rather than the state to sue abortion providers and anyone suspected of helping someone terminate a pregnancy.
He echoed the concerns of several Supreme Court justices, warning that if Texas’ law were allowed to stand, “a new and creative series of statutes could appear year after year, to be enforced by eager ideological claimants.”
FDA’S TOBACCO CHIEF LEAVING — Mitch Zeller, head of FDA’s tobacco regulatory office, plans to step down in April.
During his tenure, CTP gained the authority to regulate e-cigarettes, and has ordered millions of flavored e-cigarettes off the market. CTP also authorized the first e-cigarette for sale, though it is still deciding the fate of products from several large market share holders, including Juul, Katherine Foley writes.
“He’s been thinking about it for a while,” said a former senior FDA official not authorized to speak on the topic. “He wanted to outlast Trump and ensure that flavors [of tobacco products] were taken off the market.”
HHS’ COVID MESSAGING SPECIALIST DEPARTS — Kristina Schake is leaving the health department after nine months as its counselor for strategic communications.
Schake — whose last day is today — directed the department’s Covid-19 public education efforts, including overseeing the launch of the administration’s Community Corps and vaccination initiatives targeting hard-hit communities. She also coordinated HHS television and radio campaigns promoting the vaccines, as well as an effort to distribute Covid-19 resources in more than a dozen languages.
A longtime Democratic branding expert, Schake was previously Michelle Obama’s communications chief and worked on Hillary Clinton’s presidential campaign.
Becca Siegel, a senior adviser to the public education campaign who focused on data analytics, is also slated to leave HHS at the end of the year. Both Schake and Siegel had long planned to step down by the end of 2021.
TABAK NAMED ACTING NIH DIRECTOR — National Institutes of Health Principal Deputy Director Lawrence Tabak will take over as acting director of the sprawling science agency on Dec. 20 as longtime Director Francis Collins leaves the post.
Tabak is also an NIH veteran who served as Collins’ deputy for more than a decade and prior to that spent 10 years as the director of the National Institute of Dental and Craniofacial Research. It was largely expected that he would be tapped for the acting role, according to several people familiar with the discussions.
He can serve as acting director for 210 days. Collins himself has expressed hope that his successor would be a woman. Just one woman, Bernadine Healy, has served in the role.
— Regina Hartfield becomes CEO and president of the Sickle Cell Disease Association of America on Jan. 14. Hartfield previously worked on federal, state and commercial contracts for IT consulting firm CVP.
The CDC’s online vaccine tracker may be inflating vaccination rates, suggesting nearly every senior is vaccinated, Kaiser Health News’ Phil Galewitz reports.
Eating disorder researchers say that a gap in CDC data has left them navigating in the dark about how the disorders form and worsen, Theresa Gaffney writes for Stat News.
California’s Marin County will not be setting public health measures based on current Covid case rates, instead reorienting towards measures based on severe disease and death, SF Gate’s Eric Ting writes.
A message from PhRMA:
The Democrats’ hyper-partisan drug pricing plan is a detriment to patients and the future of medical research.
The plan guts the very incentives necessary to encourage investment in further research and development after medicines are approved, giving the government the power to pick winners and losers for lifesaving medicines.
While some would have you believe this is “negotiation,” it isn’t. It’s government price setting that does little to address patient affordability and will decimate the competitive ecosystem in the United States that has brought hope to so many Americans in the form of new medical advances where before there were none. No matter what they call it, this plan will result in the same outcome: negative consequences for the patients with the most need. Read more.
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