Wednesday, April 19, 2023

Biden to secure Covid vax for uninsured Americans

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Apr 19, 2023 View in browser
 
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By Krista Mahr and Daniel Payne

Presented by

PhRMA

With Daniel Lippman

Driving the day

A worker scans a box of the Johnson & Johnson's Covid-19 vaccine as she fills an order.

HHS has set aside as much as $1.1 billion for a program to ensure access to Covid vaccines and treatment for the uninsured into 2024. | Timothy D. Easley/AP Photo

HELP ON THE WAY — The Biden administration plans to roll out a new initiative this week that would guarantee free Covid-19 vaccines and treatments for the uninsured into 2024, POLITICO’s Adam Cancryn reports.

As Biden officials prepare to begin the so-called commercialization process later this year, the forthcoming plan for the uninsured would keep a limited supply of vaccines and therapeutics on hand to distribute free for months after the transition, according to two people briefed on the matter.

Is there any money? HHS has set aside as much as $1.1 billion for the program, according to the people briefed on the matter, with the hope that it will keep Covid care free for uninsured adults through at least the summer of 2024.

Much of that would go toward purchasing new vaccines in the fall when drugmakers are expected to update their shots and paying their distribution partners to administer them.

Who would it help? About 30 million Americans are without health insurance, though that number could grow as pandemic-era protections expire and more people lose their Medicaid coverage. A separate, preexisting federal program will continue providing free vaccinations for uninsured children.

Key context: Moderna and Pfizer plan to charge at least $110 per dose for their vaccines on the private market, though they argue much of that cost will be covered for those who have insurance.

And while the companies have pledged to make the shots free for the uninsured through patient-assistance programs, Biden officials remain skeptical that they will be structured to make the vaccines easily accessible.

WELCOME TO WEDNESDAY PULSE — Some happy news to kick off your Wednesday: Buffalo Bills’ Damar Hamlin has been cleared to play after his very scary cardiac arrest mid-game in January. Send your good news and tips to kmahr@politico.com and dpayne@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Alfred Ng, who discusses Washington state's new data privacy protections related to health information and the impact this might have on companies sharing or collecting consumer health data, as well as the possible far-reaching influence it could have on other states.

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A message from PhRMA:

What’s a pharmacy benefit manager (PBM)? They decide if medicines get covered and what people pay for them, regardless of what your doctor prescribes. These middlemen are putting their profits before your medicines. And getting between you and your doctor. You need to see what’s going on.

 
Abortion

Abortion-rights activists setup an abortion pills educational booth as they protest outside the Supreme Court in Washington, Monday, July 4, 2022.

SCOTUS is expected to rule today on whether to allow an earlier decision from the 5th Circuit Court of Appeals to take effect. | Jose Luis Magana/AP Photo

SCOTUS’ ABOUT-FACE — Abortion is back before the Supreme Court just 10 months after conservative justices said they were washing their hands of the issue, POLITICO’s Alice Miranda Ollstein reports.

The court is expected to rule today on whether to allow an earlier decision from the 5th Circuit Court of Appeals to take effect, sharply limiting nationwide access to a commonly used abortion pill.

It undercuts a core argument justices made when they overturned Roe v. Wade in June: It’s inappropriate for “unelected members of this Court” to “override the democratic process” and set national abortion policy.

While the issue before the court is a technical one that hinges on judicial and administrative processes and not the merits of the parties’ abortion-rights arguments, it will still have the kind of substantive national impact justices vowed in the Dobbs ruling to avoid.

What they said then: “This Court will no longer decide the fundamental question of whether abortion must be allowed throughout the United States through 6 weeks, or 12 weeks, or 15 weeks, or 24 weeks, or some other line,” declared Justice Brett Kavanaugh in a concurring opinion in Dobbs v. Jackson Women’s Health. “Instead, those difficult moral and policy questions will be decided, as the Constitution dictates, by the people and their elected representatives through the constitutional processes of democratic self-government.”

Up next: The anti-abortion medical groups that brought the challenge submitted arguments to the court Tuesday, pushing for the pill restrictions to take hold while arguments on the case move forward at the Texas district court, which first decided to suspend the FDA’s approval of mifepristone, and the 5th Circuit, which upheld part of that ruling.

The Supreme Court could vote this week to freeze the abortion pill restrictions indefinitely while the case unfolds in the lower courts or allow them to go forward for now.

 

GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat.

 
 
In Congress

COVID ORIGINS DEBATE RUMBLES ON — A former top intelligence official told the House Oversight and Accountability Committee on Tuesday that the CIA refuses to assess the origins of the pandemic because of the geopolitical implications, POLITICO’s Carmen Paun reports.

John Ratcliffe, who served as director of national intelligence in 2020 and 2021 during the Trump administration, dismissed a claim by the CIA that it doesn’t have enough information to say whether the coronavirus that sparked the pandemic came from nature or from a lab.

The accusation comes less than a day after a report released by Sen. Roger Marshall (R-Kan.), the top Republican on the Senate HELP Primary Health and Retirement Security Subcommittee, said the pandemic probably started with two accidental lab leaks in Wuhan, where the first cases of Covid-19 were detected in late 2019.

The CIA did not respond to a request for comment.

 

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Global Health

AFRICA’S LONG ROAD TO VACCINE AUTONOMY — Efforts underway to get vaccine manufacturing up and running in Africa face a series of existential challenges, POLITICO Europe’s Asheigh Furlong writes.

Progress so far: In an attempt to right the glaring inequities in global vaccine access laid bare during the pandemic, several European countries are pumping around €1 billion in European funds — equivalent to a little over a billion dollars — into vaccines and medicines manufacturing in Africa.

The parties on the receiving end are in South Africa: the World Health Organization’s mRNA hub at Afrigen Biologics and Vaccine, which is working to produce its own Covid-19 vaccine, and Biovac, a public-private partnership with the South African government that’s secured manufacturing deals with international vaccine makers.

Challenges ahead: As demand for Covid vaccines recedes, the new facilities would need to keep production lines warm with routine vaccines and vaccines for the many other pressing health needs that plague the continent.

To do that, they would have to secure the technology and know-how to produce them, and their national drug regulator must be able to approve the vaccines.

Perhaps most critically, they’ll need to find buyers willing to pay a higher price due to the vaccine being made in Africa.

Coronavirus

BIVALENT TAKES THE LEAD — The FDA said Tuesday that healthy adults getting a Pfizer-BioNTech or Moderna Covid-19 vaccine for the first time will receive a single bivalent shot, withdrawing its emergency-use authorization for older two-dose mRNA vaccines, Katherine Ellen Foley reports.

The agency also clarified that adults who haven’t received a bivalent booster are still eligible for one, but they don’t need an additional booster. People at higher risk of developing severe Covid, such as those with compromised immune systems or adults over 65, are eligible for an additional bivalent booster four months after their first shot.

The original mRNA shots from Pfizer-BioNTech and Moderna will no longer be used. Adults who have received one original mRNA shot will receive a second dose via the bivalent shot.

Children 5 years and under who have never been vaccinated can receive either two doses of Moderna’s shot for kids or three doses of the Pfizer-BioNTech shot. Those 5 years and older can receive two doses of Moderna’s bivalent shot or one dose of the Pfizer-BioNTech bivalent shot.

What’s next: The CDC must endorse updates to the Covid vaccine schedule. The CDC’s expert advisers meet today to discuss the updates. While the agency doesn’t have to follow its panel’s recommendations, it usually does.

The FDA is also expected to hold an advisory meeting in June to discuss Covid boosters for the fall.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
HEALTH TECH

FALLOUT OF PRIVACY CRACKDOWN — A series of federal data privacy crackdowns is complicating how health care companies market their services online, POLITICO’s Ruth Reader reports.

New action from both the FTC and HHS to protect customer health data is upending longstanding business practices and sending the health care industry scrambling. In some cases, firms are cutting ties with tech giants like Google and Facebook as they try to understand the regulatory landscape and measure the fallout to their bottom lines.

The upshot: While consumers might benefit from greater privacy protection, health care providers find it more difficult to acquire new patients as they slash their spending on targeted advertising in the new regulatory environment.

Names in the News

Kelli Briggs is joining the Klein/Johnson Group as a principal, where she will run point for the firm’s outreach to House Republicans. She’s currently the head of government and industry affairs for health care AI startup Olive.

What We're Reading

The Wall Street Journal reports on the launch of a federal study of Gulf War Illness, a mysterious condition that impacts hundreds of thousands of troops that served in the Persian Gulf.

KFF writes about the wave of social media attention that new weight-loss drugs are getting — and may be escaping regulators’ attention.

Roll Call reports on a new PAC focused on children’s issues.

 

A message from PhRMA:

Insurers and their PBMs don’t want you to see that you could be paying more than they are for your medicines. Rebates and discounts can significantly lower what insurers and PBMs pay for medicines. These savings can reduce the cost of some brand medicines by 50% or more. But insurers and PBMs aren’t required to share those savings with you at the pharmacy counter.

They don’t want you to see that they use deductibles, coinsurance and other tactics to shift more costs on to you. Or that the three largest PBMs control 80% of the prescription drug market. Or that last year they blocked access to more than 1,150 medicines, including medicines that could have lowered costs for you at the pharmacy. 

PBMs and insurance practices are shrouded in secrecy,  they need to be held accountable.  

 
 

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