1 big thing: Candidates vs. industry 

2. CVS Caremark sued over Medicare pharmacy fees

3. Charted: Medical claims linked to opioid use

4. Lenient drug laws didn't change overdose deaths

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5. Catch up quick

Happy Thursday, Vitals crew. Today's newsletter is 921 words or a 3½-minute read.

Thanks for reading Axios Vitals, and to health care editors Adriel Bettelheim and Jason Millman and copy editors Matt Piper and Bryan McBournie. Please ask your friends and colleagues to sign up.

Vitals

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Keep up with health care politics, policy and business

Axios Vitals

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1 big thing: Judge shuts down major pharma argument

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2. Insurer cuts drug co-pays before negotiations

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3. FDA's plan to scrutinize more lab tests

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4. 1 big stat: Vaccination update

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5. While you were weekending

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Welcome to the start of a new week, Vitals readers. Today's newsletter is 934 words or a 3.5-minute read.

Situational awareness: A strike of more than 75,000 Kaiser Permanente workers later this week appears more likely after their labor contract expired over the weekend.

Thanks for reading Axios Vitals, and to health care editor Jason Millman and copy editor Matt Piper. Please ask your friends and colleagues to sign up.

1 big thing: Reducing fertility treatment disparities

2. New ARPA-H hubs

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3. Surge in 340B purchasing

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4. Big summer for health care jobs

Happy Wednesday, Vitals crew. Today's newsletter is 973 words or a 3.5-minute read.

Situational awareness: The average Medicare Advantage premium next year will remain stable, rising 64 cents to $18.50, Medicare said Tuesday. 

1 big thing: Vax rollout problems linger

Illustration of a vaccine card with a giant question mark over it

2. Kaiser workers closer to striking 

3. Hospitals' improving post-COVID fortunes

4. WHO backs second malaria vaccine

It's Oct. 3, Vitals crew. Today's newsletter is 1,136 words or a 4.5-minute read.

1 big thing: Blue cities rethink drug policies

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2. More help for pregnant vets

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3. 1 big stat: Innovation's costs

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4. Post du jour: It is what it is

A post on X that reads: Lots of people are asking why #COVID19 vaccine roll-out has been so rocky. Yes, it's the first time these products have been commercialized. But also, welcome to the American health care system.

6. Cat of the week 

Happy Friday, Vitals readers. Today's newsletter is 942 words or a 3.5-minute read.

National

Pregnant veterans will soon have vastly expanded access to so-called maternity care coordinators who provide a range of supportive services, the Department of Veterans Affairs told Axios first.

Why it matters: The announcement is part of the Biden administration's efforts to tackle the country's maternal health crisis and seeks to help a population that may be at heightened risk of pregnancy complications. 

Catch up quick:  Starting Oct. 1, maternity care coordinators will be available to veterans a full year after birth, up from eight weeks currently. 

Since 2012, these coordinators have helped veterans navigate care both inside and outside of the VA system.

Coordinators help connect people to community resources and care, offer support after pregnancy loss and answer medical billing questions. Veterans can receive coordinator services as soon as they have a positive pregnancy test, according to a department spokesperson.

Coordinators touch base with veterans every three months throughout the pregnancy. The new expansion extends the scheduled contacts for another twelve months after delivery. 

Postpartum care is crucial: More than half of pregnancy-related deaths happen between one day and one year after giving birth. About 1 in 8 happen after six weeks postpartum, according to a 2019 study.

By the numbers: Pregnancies among women using VA care reached 12,524 in 2022, up more than 80% since 2014. 

In 2015, the maternity care coordinator program served 957 pregnant veterans.

What they're saying: "Extending postpartum care coordination up to one year allows VA maternity care coordinators the ability to double the amount of contact with their patients," Sally Haskell, acting chief officer for the VA Office of Women's Health, said in a statement. 

The extended service could especially help veterans living in areas lacking sufficient maternity care resources, a VA spokesperson noted. 

March of Dimes has classified 36% of counties as maternity care deserts.

Context: A two-year-old law aimed at supporting pregnant veterans included $15 million for maternity care coordinators. 

The law, known as the Protecting Moms Who Served Act, also required the government to conduct a comprehensive study of pregnancy complications among women veterans.

Veterans to get extended postpartum care services

Maternity care coordinators will be available to veterans a full year after birth, up from eight weeks currently.

Veterans

Pregnant veterans will soon have vastly expanded access to so-called maternity care coordinators who provide a range of supportive services, the Department of Veterans Affairs told Axios first.Why it matters: The announcement is part of the Biden administration&#x27;s <a class="gtmContentClick" data-vars-link-text="efforts" data-vars-click-url="https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf" data-vars-content-id="1678f70b-f97f-496a-8d96-34e0590e41e5" data-vars-headline="Veterans to get extended postpartum care services" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf" target="_blank">efforts</a> to tackle the country&#x27;s <a class="gtmContentClick" data-vars-link-text="maternal health crisis" data-vars-click-url="https://www.axios.com/2023/08/02/maternal-mortality-birth-death-disparities" data-vars-content-id="1678f70b-f97f-496a-8d96-34e0590e41e5" data-vars-headline="Veterans to get extended postpartum care services" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/08/02/maternal-mortality-birth-death-disparities" target="_self">maternal health crisis</a> and seeks to help a population that may be at heightened risk of <a class="gtmContentClick" data-vars-link-text="pregnancy complications" data-vars-click-url="https://www.va.gov/HEALTHEQUITY/Women_Veterans_and_Pregnancy_Complications.asp" data-vars-content-id="1678f70b-f97f-496a-8d96-34e0590e41e5" data-vars-headline="Veterans to get extended postpartum care services" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.va.gov/HEALTHEQUITY/Women_Veterans_and_Pregnancy_Complications.asp" target="_blank">pregnancy complications</a>.

The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

Health

Medicare Advantage insurer SCAN is getting ahead of the program's planned drug price negotiations by offering seniors free or $11 monthly co-pays for 13 name-brand drugs, the carrier told Axios first.

Why it matters: The nonprofit will make the changes for the 2024 plan year — two years before the first negotiated prices are supposed to take effect.

"We don't have to wait for the government. We can have the rigor and figure out additional ways ourselves," Sharon Jhawar, SCAN's chief pharmacy officer, said in an interview.

Details: Six drugs on SCAN's new formulary tier are also on Medicare's list of drugs slated for price negotiation, including the blood thinners Eliquis and Xarelto and the diabetes medicine Jardiance.

SCAN chose cardiovascular and diabetes drugs with no generic alternative, which make them extra costly to insurers and, ultimately, patients.

Beneficiaries eligible for both Medicare and Medicaid, along with those in plans targeted to patients with diabetes and heart failure, will have no co-pay for the drugs, Jhawar said. Consumers in other offerings will pay $11 out of pocket.

None of the drugs will be subject to prior authorization or similar strategies.

Currently, SCAN members see co-pays ranging from about $30 to $50 for these drugs.

SCAN is using money that otherwise would have been booked as profits to offer the lower co-pays. Jhawar said the discounts won't require the insurer to cut back other benefits.

Of note: SCAN's policy will take effect even if the courts halt the Medicare drug price negotiation process.

"We feel strongly that these are medications that we should help older adults have better access to," Jhawar said.

The big question: Will lowering consumer costs for blockbuster heart and diabetes drugs end up lowering SCAN's total costs?

More than 20% of American seniors last year reported not taking their medication due to cost concerns. SCAN will measure how the total cost of care and outcomes change when price concerns are mitigated, Jhawar said.

Medicare Advantage plan slashes drug co-pays ahead of negotiations

SCAN is offering seniors free or $11 co-pays for 13 name-brand drugs, including most facing government negotiations.

Drug prices

Medicare Advantage insurer SCAN is getting ahead of the program&#x27;s planned <a class="gtmContentClick" data-vars-link-text="drug price negotiations" data-vars-click-url="https://www.axios.com/2023/08/28/biden-medicare-drug-negotiations-list" data-vars-content-id="1b9452dc-b10c-4496-b38f-b7c444513dd8" data-vars-headline="Medicare Advantage plan slashes drug co-pays ahead of negotiations" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/08/28/biden-medicare-drug-negotiations-list" target="_self">drug price negotiations</a> by offering seniors free or $11 monthly co-pays for 13 name-brand drugs, the carrier told Axios first.Why it matters: The nonprofit will make the changes for the 2024 plan year — two years before the first negotiated prices are supposed to take effect.

Tests for COVID-19, blood lead levels, breast cancer genes and other conditions could soon be held to higher accuracy standards under a much-anticipated plan from federal regulators. 

The big picture: The Food and Drug Administration on Friday rolled out a plan to regulate lab-developed tests that have long escaped close agency scrutiny as Congress drags its feet on the issue. But the renewed effort to regulate so-called LDTs could face strong industry opposition.

Where it stands: Testing laboratories are regulated by the Centers for Medicare and Medicaid Services, but the agency doesn't evaluate the accuracy of a test, require adverse event reporting or provide protections to patients in clinical trials.

Theranos, the disgraced blood testing company founded by Elizabeth Holmes, fell into the regulatory loophole and went to market without FDA review.

Catch up quick: FDA has become increasingly concerned about the quality of lab tests, the proposed rule says. FDA wants to treat tests made in laboratories like medical devices.

FDA has said for years that regulating lab-developed tests falls within its authority, and the agency released a draft guidance on regulating tests in 2014. But after two years of strong pushback from industry, FDA pulled its proposal.

Congress in 2018 started working on legislation to create a new regulatory framework for lab-developed tests under the FDA. The bipartisan bill is still held up in Congress and was cut from a big legislative package last year due to concerns over how it would affect academic medical centers that make their own tests.

FDA said it would phase in LDT regulation over five years.

What they're saying: "FDA, is, I guess, sort of playing chicken [with Congress] by coming out with this rule and saying we're going to go ahead and regulate," said Jeffrey Shapiro, a partner at law firm King & Spalding who specializes in medical device law.

Some have raised concern the FDA doesn't have the capacity to quickly review tests.

"Unless FDA dramatically expands its workforce, they could easily become a bottleneck for important tests," Shapiro said. "Tests that are important for public health, especially newer and more innovative tests."

The lab testing industry opposes the proposal, and the American Clinical Laboratory Association said FDA regulation of lab tests should have to come through legislation.

Consumer advocates say the plan would ensure patients can rely on tests that, among other things, diagnose cancer and Alzheimer's disease. 

It would "close a gaping hole in FDA's current regulatory reach," Peter  Lurie, president of Center for Science in the Public Interest and a former FDA official, said in a statement.

What's next: Expect legal action against the regulatory framework if FDA finalizes the proposal — and maybe even before then, Shapiro said.

FDA targets more oversight of lab-made tests

Tests for COVID-19, breast cancer genes and other conditions could be held to higher standards under a plan from federal regulators.

Medical devices

Tests for <a class="gtmContentClick" data-vars-link-text="COVID-19" data-vars-click-url="https://www.axios.com/health/coronavirus" data-vars-content-id="7fdb8116-dd5b-4cfa-a364-88f04c79df9b" data-vars-headline="FDA targets more oversight of lab-made tests" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/health/coronavirus" target="_self">COVID-19</a>, blood lead levels, breast cancer genes and other conditions could soon be held to higher accuracy standards under a much-anticipated plan from federal regulators. The big picture: The Food and Drug Administration on Friday rolled out a plan to regulate lab-developed tests that have long escaped close agency scrutiny as <a class="gtmContentClick" data-vars-link-text="Congress drags its feet" data-vars-click-url="https://www.axios.com/pro/health-care-policy/2023/03/29/valid-act-diagnostic-tests-future" data-vars-content-id="7fdb8116-dd5b-4cfa-a364-88f04c79df9b" data-vars-headline="FDA targets more oversight of lab-made tests" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/pro/health-care-policy/2023/03/29/valid-act-diagnostic-tests-future" target="_self">Congress drags its feet</a> on the issue. But the renewed effort to regulate so-called LDTs could face strong industry opposition.

Early hiccups that have complicated the rollout of updated COVID-19 vaccines should be resolved in the next couple of weeks, experts and pharmacy groups told Axios.

Driving the news: There have been widespread reports of dropped or limited vaccine appointments, making it difficult for some to get the shot almost three weeks after federal officials cleared it and encouraged people to protect themselves as cases were rising. 

Though experts said supply-chain issues appear to be easing, it may be two more weeks before every adult can easily make an appointment where they want.

The big picture: Some supply-chain issues were expected during the new vaccination campaign, the first one being managed by the commercial market and not the federal government.

Vaccine makers Moderna and Pfizer say they've made enough doses to meet demand. Pharmacy chains where many Americans will get their shots say they had been waiting on shipments, but things are improving.

Distribution pipelines to national chains like CVS and Walgreens and community pharmacies are in good shape, but it could take another week or two to completely resolve distribution issues at other locations, including physician offices and nursing homes, a Health and Human Services spokesperson told Axios.

Anecdotally, more community pharmacies report having the vaccine this week compared to last week, said Andie Pivarunas, a spokesperson for the National Community Pharmacists Association. 

"However, it takes some time for the vaccine to get through the supply chain," Pivarunas said.

Where it stands: CVS is receiving vaccines on a rolling basis, but it's had to reschedule some appointments due to delivery delays from wholesalers, a company spokesperson told Axios.

Walgreens on Monday said all stores now have enough supply to meet demand and will continue to make more appointment times available.

It appears one rollout problem has been largely fixed: Insurers last week said they'd resolved technical issues that resulted in some people being told they would have to pay over $100 for shots, even though they're supposed to be free at in-network providers. 

Around 1.8 million people reportedly got a COVID-19 vaccine in the week ending Sept. 22. 

What they're saying: "In this new system, which is really our old system of how we do things, these challenges are going to come up," said Jennifer Kates, a senior vice president at KFF whose own vaccine appointment was canceled. She predicted the issues are mostly due to "first-time privatization challenges."

"Hopefully in the next two to three weeks, I think we'll see a very big difference," Kates said.

Of note: Fixing COVID vaccine delays for kids could take longer. Manufacturers shipped adult doses before pediatric ones, which come in different packaging. That explains some of the access issues, Kates said. 

Pediatricians also report ongoing issues with insurance reimbursement for the vaccines, leaving parents of the youngest kids with fewer options since pharmacists don't have the authority to vaccinate kids under 3.

"Those are enduring challenges, and I don't know how they're going to be easily solved," Kates said.

The CDC is hosting a town hall with pediatricians Wednesday on COVID-19 vaccine recommendations and distribution, the Washington Post reported.

The bottom line: At least for adult vaccines, "the next time there is an updated formulation of COVID vaccines, we should not experience the same issues," Kates said

COVID vaccine rollout issues may take 2 more weeks to resolve, experts say

Illustration of a CDC Covid vaccine card with a big question mark drawn on in crayon.

COVID vaccine boosters

Charted: Medical claims related to opioid dependence

In several states, the percentage of claims related to opioid dependence increased over the years studied.

Opioids

Private insurers saw the percentage of medical claims stemming from opioid dependence fall slightly from 2018 to 2022 in the United States, according to <a class="gtmContentClick" data-vars-link-text="data released by FAIR Health" data-vars-click-url="https://www.fairhealth.org/fh-trackers/opioid-abuse-map" data-vars-content-id="c1246da9-fd74-4f39-b50d-dde71a6660f0" data-vars-headline="Charted: Medical claims related to opioid dependence" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.fairhealth.org/fh-trackers/opioid-abuse-map" target="_blank">data released by FAIR Health</a>.The big picture: Opioid use and dependence accounted for about two-tenths of 1% of total claims in 2022, compared to one-quarter of 1% in 2018.

Maya Goldman

Stories

COVID vaccine rollout issues may take 2 more weeks to resolve, experts say

Medicare Advantage plan slashes drug co-pays ahead of negotiations

FDA targets more oversight of lab-made tests

Veterans to get extended postpartum care services

Charted: Medical claims related to opioid dependence

Newsletter editions

Lingering vax rollout problems

Pharma's rejected argument

Second-guessing drug policies

GOP's tough talk

Addressing fertility barriers