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With help from Robert King

2024 HEALTH CARE PLAYBOOK — While GOP candidates didn’t discuss health care at length during the first presidential debate of the cycle Wednesday, President Joe Biden has been leaning into health care messaging.

Abortion figures to be a major part of his campaign. It proved to be effective for Democrats in the 2022 midterms and in state ballot initiatives.

Biden’s campaign released ads on Fox News’ website ahead of the GOP debate pledging to restore Roe v. Wade with a “Dark Brandon” meme. A Pro-Biden super PAC has run ads saying Biden will protect abortion rights.

During the debate, his campaign flooded the zone with attacks on the Republican candidates’ stances on abortion, clearly viewing the issue as a political winner.

“MAGA Republicans continue to unsuccessfully invent new policy positions for President Biden to distract from their deeply unpopular and dangerous support for banning abortion in every state across the country,” Kevin Munoz, Biden’s campaign spokesperson, said in a statement. “Americans have rejected the extreme, anti-choice positions of MAGA Republicans in the midterms and in elections throughout this year. They will again in 2024.”

Meanwhile: Republican National Committee Chair Ronna McDaniel said Thursday that she was “very pleased” to see GOP candidates discuss abortion in the debate.

“If our candidates aren’t able to fend a response and put out a response, we’re not going to win,” she said on Fox News.

The Inflation Reduction Act will also play a significant role in Biden’s campaign through a framing of lowering health care costs. He’s touted the annual $2,000 Medicare cap on prescription drugs and the $35-a-month insulin cap and is set to take a victory lap Tuesday as his administration announces the first 10 drugs set for Medicare price negotiation.

Expanding access to mental health care — an issue that has bipartisan support — will also be a tenet of Biden’s pitch. He’s already touted his new mental health parity proposed rule.

Expect Biden to try to draw a contrast with Republicans’ health care proposals, especially on abortion, and tout the administration’s Covid recovery.

A key challenge for Biden will be selling changes under the Inflation Reduction Act since many will take years for voters to feel. And legal challenges to the drug price negotiation provisions could cause bumps in the road. A Covid surge could also blunt his message.

WELCOME TO FRIDAY PULSE. Are you involved with health care in Biden’s campaign? We want to hear from you. Reach me at [email protected]. We can keep you anonymous. Plus, send me or Chelsea ([email protected]) general tips, scoops and feedback. Follow along @_BenLeonard_ and @ChelseaCirruzzo.

TODAY ON OUR PULSE CHECK PODCAST, host Carmen Paun talks with POLITICO White House correspondent Adam Cancryn about his exclusive reporting on the White House’s plan to unveil the first 10 drugs selected for Medicare price negotiations next week and the subsequent legal and political fights over health care costs that can be expected.

SEPTEMBER VAX TIMELINE, FEDS PROMISE — Federal officials still expect a mid-September timeline for access to updated Covid-19 vaccines and say drugmakers believe the updated shot will still provide protection against the emerging EG.5 variant, Chelsea reports.

Background: Three companies have submitted data on their updated Covid shots for authorization. Officials say the updated shots, formulated toward the XBB.1.5 strain, an Omicron subvariant, will protect people against severe infections leading to hospitalization or death.

On a call with reporters Thursday, CDC and FDA officials said the FDA is expected to fully authorize the updated mRNA shots for people ages 12 and up and grant emergency use authorization for mRNA shots for children 11 and under. The Novavax vaccine, a protein-based vaccine, would receive emergency use authorization, officials say, which is based on when the application was submitted.

Officials added that the CDC’s vaccine advisory committee will likely meet almost immediately following FDA authorization to avoid any delays. Those recommendations would also be tied to payment and insurance coverage of the vaccines.

POLITICO previously reported that officials are racing to secure contracts with pharmacies to offer the shot to uninsured Americans at the same time it becomes accessible for other Americans. Officials also said they plan to focus outreach on long-term care facilities, with CDC Director Mandy Cohen personally visiting facilities.

The wait for vaccines comes as Covid hospitalizations spike, though officials say they’re at a third of what they were one year ago.

ACOS SAVE MEDICARE NEARLY $2 BILLION — Accountable care organizations tasked with coordinating care for the Medicare population generated more than $1.8 billion in savings last year, slightly above savings from 2021, Robert reports.

CMS released data Thursday on the savings generated by ACOs in the Medicare Shared Savings Program. ACOs are groups of hospitals or doctors that agree to meet certain spending and quality targets and get a share of any savings, but they must repay Medicare if they miss the mark.

“We are encouraged and inspired by six consecutive years of savings and high-quality care, with 2022 being one of the strongest years of performance to date,” said Meena Seshamani, director of the Center for Medicare, in a statement.

Of the 482 ACOs participating in the program, 63 percent earned shared savings payments, according to the CMS release.

The advocacy group National Association of ACOs said that the results underscore the need for Congress to extend a 5 percent bonus to doctors who participate in an alternative payment model that runs through 2023.

INSURERS ROLL BACK PRIOR AUTH AMID SCRUTINY — Cigna said Thursday it’s the latest insurer to reduce its use of prior authorization, including in Medicare Advantage plans, cutting about a quarter of services from such requirements.

UnitedHealthcare made a similar move in March, and Aetna has also made reforms around prior authorization.

The larger context: The changes come as Congress and CMS have scrutinized insurers’ decision-making processes for approving treatments. The agency proposed a rule in December that would require health insurance companies to modernize the way they process treatment-authorization requests from providers.

In June, more than 230 representatives and 61 senators led by Rep. Suzan DelBene (D-Wash.) called on the agency to go further in its rule.

PET SCAN EXPANSION SCRUTINIZED — While CMS has proposed expanding coverage of a type of screening for Alzheimer’s disease, some groups say the proposal might still delay care at a crucial moment for patients, Chelsea reports.

Background: In July, CMS proposed removing the national coverage determination on a type of PET scan imaging that determines the presence of amyloid-beta in the brain, a protein that some experts consider to be a hallmark of Alzheimer’s.

Previously, CMS allowed Medicare to cover only one of the scans in a beneficiary’s lifetime when enrolled in a clinical trial but said the new drugs warranted reconsideration.

The two Alzheimer’s drugs, Leqembi, which the FDA granted full approval to earlier this year, and Aduhelm, given accelerated approval in 2021, work by targeting the amyloid-beta for patients in the disease’s early stages. Alzheimer’s advocacy groups say patients can’t use the drugs effectively if they’re not diagnosed via a PET scan quickly enough.

But the groups also say CMS’ proposal to leave coverage decisions up to Medicare Administrative Contractors, private insurers that process Medicare claims, might lead to delays in care as each decides its own coverage policies.

“We are concerned that leaving coverage to the discretion of local contractors could result in variability of coverage and beneficiary access delays to early diagnosis and intervention,” the Alliance for Aging Research wrote in its public comments on the proposal before the comment period closed on Monday.

Instead, they say CMS should retain national coverage decisions, which would “provide consistent and clear coverage immediately once such a policy was finalized,” the Medical Imagery & Technology Alliance also commented.

What’s next: CMS has listed October 15 as its deadline for reconsidering the proposal.

Amanda Malakoff is now senior director of government affairs for BridgeBio. She was previously executive director of the Rare Disease Company Coalition.

Alex Schriver is joining PhRMA as senior vice president of public affairs. He’s leaving a position as head of public affairs at Targeted Victory.

HealthInfoSec reports that the massive health data breach toll from a May hack of a software tool is growing.

STAT reports on Vivek Ramaswamy’s brashness that made waves in biotech.