Tuesday, December 20, 2022

Axios Vitals: Congress' health moves

Plus, FDA's tobacco regulation struggles | Tuesday, December 20, 2022
 
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Axios Vitals
By Tina Reed · Dec 20, 2022

Good morning, Vitals readers.

🔮 1 fun thing: What are the top health stories we're watching in 2023? Senior editor Adriel Bettelheim joined Axios' Today podcast host Niala Boodhoo with his predictions.

Now, today's newsletter is 994 words or a 4-minute read.

 
 
1 big thing: Congress saves big health care decisions for last

Illustration: Shoshana Gordon/Axios

 

There's plenty for health care interest groups in Congress' year-end spending package, but some had to make significant concessions: There will be no pandemic commission, doctors will have to swallow some Medicare payment cuts and FDA oversight of diagnostic tests will not change, Axios' Victoria Knight, Peter Sullivan and Maya Goldman write.

Why it matters: The health care riders in the year-end spending package reflect which health care interests have clout, and which issues lawmakers want to punt into next year, when Congress will be divided and deals may be more elusive.

Here's where things stand:

Doctors cuts: The package will stave off 2.5 percentage points of a scheduled 4.5% cut to the Medicare physician fee schedule in 2023, and 1.25 percentage points of cuts in 2024.

Medicaid coverage: People could begin to be bumped from the safety net program if they don't meet eligibility requirements starting on April 1, but the process will occur over a one-year period.

FDA oversight: Several FDA reforms which had bipartisan support in the House made it into the package. They include revamping a fast-track drug approval process that lets drugmakers sell their products based on preliminary evidence.

Pandemic preparedness: Parts of a pandemic preparedness bill made it into the legislation, but the deal won't create a 9/11-style commission to examine the COVID response. It will, however, make the CDC director into a Senate-confirmed position.

Telehealth: Medicare telehealth flexibilities will be extended for two years. The provisions have already been extended for 151 days after the end of the COVID-19 public health emergency.

Opioids: The omnibus also will include a bill to remove a requirement that providers get a special waiver from the Drug Enforcement Administration before being able to prescribe buprenorphine, a treatment for opioid addiction.

Read the rest.

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💰 2. Medicare spending on tests surged in 2021

Medicare Part B spending on lab tests surged 17% last year to $9.3 billion, driven by higher volumes of COVID-19 tests and demand for genetic tests that exceeded pre-pandemic levels, a federal watchdog report found, Axios' Adriel Bettelheim writes.

Why it matters: Though testing in the U.S. fell off during the first half of 2021, it picked up with the arrival of the Delta and Omicron variants.

  • And the increased availability of at-home COVID tests will likely continue the upward trend this year, the HHS Office of Inspector General said in the report.

By the numbers: Medicare Part B spent $2 billion on COVID-19 tests last year, a 29% increase over 2020.

  • Spending on four categories of high-priced genetic tests — including genomic sequencing procedures — increased 56%, from $1.2 billion in 2020 to $1.9 billion in 2021. The average payment stood at $666 per test.

Be smart: The findings further quantify the financial effects of the pandemic on the public health program — and reflect the increased use of personalized treatments that target specific genetic traits, or markers.

  • Auditors have also focused on how labs bill Medicare for diagnostic tests, finding that 378 labs billed Medicare Part for questionably high levels of add-on tests alongside COVID-19 tests in 2020.
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3. Report details FDA struggles regulating tobacco

Illustration: Sarah Grillo/Axios

 

The arm of the FDA that oversees tobacco products has "struggled to function as a regulator" and has been "forced to operate primarily in a reactive mode" a report released Monday by the Reagan-Udall Foundation found.

Why it matters: It is the second independent report that FDA commissioner Robert Califf asked for last summer and comes on the heels of a scathing assessment, also from Reagan-Udall, which found deep cultural and systemic problems at FDA were contributing to vulnerabilities in the U.S. food system.

Zoom in: The tobacco report came from a panel chaired by former FDA chief of staff Lauren Silvis and had a more limited scope and was more measured in its criticisms.

  • But its findings similarly highlight a number of shortcomings within the agency that were self-inflicted.

What they're saying: The work by the FDA's Center for Tobacco Products [CTP] has been made more difficult by the sheer volume of product applications it receives, the amount of agency leadership turnover it's encountered and "near constant litigation" it faces," the report read.

  • It "has also struggled to function as a regulator in part due to some of its own policy choices," the report read, saying the breadth and timelines related to product review regulations "have been difficult for both stakeholders and CTP to apply in practice."

Read the rest.

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4. Medicaid enrollment to top 100 million

The number of Americans on Medicaid is expected to surpass 100 million as early as next month, according to a new projection from the Foundation for Government Accountability.

Why it matters: The record uninsured rate — achieved through both Affordable Care Act subsidies and Medicaid expansion — has been a point of pride for the Biden administration, particularly in light of stark health disparities exacerbated by the pandemic.

  • Yes, but: The right-leaning think tank, which opposes Medicaid expansion, points out the record Medicaid enrollment means nearly 1 in 3 Americans will be on the federal government's rolls.

State of play: Under the COVID public health emergency, state Medicaid agencies are required to continue health care coverage for all medical assistance programs, even if someone's eligibility changes.

According to an FGA projection, there are about 98 million people on Medicaid with at least 21 million of those enrollees earning too much money to qualify.

  • KFF estimates between 5.3 million and 14.2 million Medicaid enrollees could be disenrolled after the end of the health emergency.
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5. Catch up quick

💊 CVS and Walgreens are limiting purchases of children's pain and fever medicine. (Bloomberg)

🏛 The Supreme Court temporarily halted the end of a COVID-era border policy. (Axios)

🦠 China is racing to bolster its health system as COVID surge sparks global concern. (Reuters)

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