Tuesday, December 13, 2022

💊 Axios Vitals: Biden's pricing challenges

Plus, navigating reproductive data security | Tuesday, December 13, 2022
 
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Axios Vitals
By Tina Reed · Dec 13, 2022

Hello there, Vitals readers. Today's newsletter is 1,122 words or a 4-minute read.

👋 We'd love to see you: Join Axios' Caitlin Owens and Victoria Knight tomorrow at 12:30pm ET for a virtual event looking at the future of telehealth policy after the midterms and heading into 2023.

  • Guests include Rep. Cathy McMorris Rodgers (R-Wash.) and Rep. Mike Thompson (D-Calif.). Register here to attend.
 
 
1 big thing: Biden's drug pricing decisions aren't over

Illustration: Shoshana Gordon/Axios

 

The Biden administration faces a host of high-stakes decisions on prescription drug costs over the next several months, Axios' Caitlin Owens writes.

The big picture: Democrats just delivered on their decades-long promise to allow Medicare to negotiate drug prices in the Inflation Reduction Act (IRA).

  • But that legislative victory kicked off a series of difficult decisions the administration will have to make as it decides how much further to go addressing costs.

State of play: Democratic members of Congress have been explicit about what they want to see next, including the first-time use of government authorities to take over patents on expensive drugs in order to lower prices.

  • Republicans, for their part, have made it clear that they plan to closely monitor the administration's implementation of the IRA's drug pricing provisions — and it's widely expected that someone will eventually take the administration to court over the law.
  • Outside groups are agitating for the administration to take a more aggressive approach in making COVID tests and treatments available globally, by expanding a waiver to the World Trade Organization's intellectual property protections.
  • And a new Alzheimer's drug could be approved within weeks, forcing Medicare to make difficult coverage decisions that could balloon the agency's drug spending.

The other side: The pharmaceutical industry and its allies have said that undermining patents — either through march-in rights, the WTO waiver or patent reform — will endanger innovation.

The bottom line: The administration is ultimately trying to strike a balance between lowering drug prices and encouraging medical innovation. No matter what it does, it's going to be accused of failing at one or the other.

  • It could even be accused of failing at both if it manages to anger both Democrats and Republicans.

A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off.

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2. Monkey export crackdown hurts pharma

A Cambodian crackdown on the export of non-human primates could threaten drug research in the U.S., STAT News reports.

Catch up quick: Last month, U.S. federal prosecutors charged eight people, including two Cambodian officials, with allegedly smuggling endangered wild long-tail macaques.

  • That affected the supplier of the primates to contract research organization Inotiv, which supplies the animals to labs around the U.S.
  • The company disclosed two of its subsidiaries — Orient BioResource Center and Envigo Global Services — were subpoenaed in connection with an investigation into the importation of the animals.

Why it matters: The majority of non-human primates used in U.S. research are imported from Cambodia.

What they're saying: "Depending on the duration of restrictions on these imports, drug discovery and development in the U.S. could be materially impacted," Inotiv said in a preliminary financial statement.

  • Cambodian officials have said plan to "seek justice" for its officials.

The big picture: Analysts warn the financial impacts of Cambodia halting the export of non-human primates could ripple across U.S. contract research organizations.

  • "During COVID when China cut off the supply to the U.S., the cost for cynomolgus macaques skyrocketed to more than $10,000 per monkey assuming one could even find one. If Cambodia refuses to export to the U.S., that number will grow dramatically," Raymond James said in a research note.
  • "If this becomes an ongoing issue, development of future treatments and vaccines could be hindered as a result of lacking the needed primates," they said.

Be smart: If the name Envigo sounds familiar, it could be because U.S. inspectors seized 4,000 beagles from a company facility earlier this year after finding signs of mistreatment of the animals.

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3. Navigating reproductive data security

Illustration: Aïda Amer/Axios

 

Reproductive data is scattered throughout a patient's medical record, with few ways to automate processes of redacting sensitive information, Axios' Claire Rychlewski writes.

Why it matters: Since Roe v. Wade was overturned, health care providers have been scrambling to respond to varying state regulations around reproductive freedom, and figuring out how to best protect patient data.

  • As Axios' Oriana Gonzalez reported earlier this year, the new post-Roe landscape is testing the suitability of the Health Insurance Portability and Accountability Act, or HIPAA.

The big picture: Some states, including Delaware, Connecticut, New Jersey and California, have enacted legislation protecting reproductive health information.

  • Many of those laws forbid the release of abortion records, protect people from extradition for criminal charges related to abortion, and establish the states as not subject to other states' abortion regulations.
  • Similar legislation is expected in Colorado, Hawaii, Illinois, Maine, New Mexico, New York, Oregon, Rhode Island and Washington.

Yes, but: The regulation is somewhat broad — and doesn't necessarily account for every piece of reproductive data that might be lurking in corners of an EMR, says Elizabeth Delahoussaye, chief privacy officer of Ciox. The company is a major player in health information management that is counseling providers on how to navigate different regulatory environments.

The bottom line: "Reproductive health isn't in a box. It's all over that medical record," she says.

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A message from Dialysis Patient Citizens

Dialysis patients are speaking out
 
 

Dialysis patients are at risk of losing their insurance coverage — but there are steps you can take to help.

Why it's important: Kidney disease requires hours of treatment every week; patients deserve to make the best choice for their health coverage.

Hear their stories.

 
 
4. Health risks of extreme temps

Illustration: Sarah Grillo/Axios

 

Scientists find exposure to extremely hot or cold temperatures increases a heart disease patient's risk of death, according to a study published in Circulation, Axios' Ayurella Horn-Muller writes.

The big picture: The research demonstrates the deadly intersection between weather extremes and cardiovascular diseases on a multi-national scale.

By the numbers: Researchers looked at extreme temperature associations of more than 32 million cardiovascular deaths that occurred over 40 years.

  • Extreme temperature days contributed to roughly 11.3 additional deaths out of every 1,000 cardiovascular deaths analyzed.
  • Extreme hot days were linked to 2.2 additional deaths experienced by heart disease patients, while 9.1 additional deaths were experienced on extremely cold days.
  • This escalating risk was true for multiple common cardiovascular conditions, but was especially pronounced for people with heart failure.

Yes, but: Although study authors connect the effects of climate change and extreme temperatures driving these mortality rates, winters have warmed in 97% of over 200 U.S. locations since 1970, shrinking cold snaps and reducing annual minimal temperatures, according to data by Climate Central.

Go deeper.

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5. Data du jour: This season's flu deaths
Data: CDC; Chart: Sara Wise/Axios

The number of flu deaths in the U.S. this season is far outpacing rates seen at this time over the last two years.

Why it matters: While it's still too early to know how bad this season will get, CDC officials have warned the virus is clearly back after a sharp drop in flu rates in the midst of the pandemic.

Data: CDC; Map: Erin Davis/Axios Visuals
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6. Catch up quick

👉 In rural America, the deadly costs of opioids outweigh the dollars tagged to address them. (KHN)

🏛 The Supreme Court refused to block California's ban on flavored tobacco. (New York Times)

💰 New Jersey's state health plan is paying more — sometimes way m0re — for medical care than providers charge. (Bloomberg News)

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A message from Dialysis Patient Citizens

Dialysis patients deserve to choose their family's health coverage
 
 

Dialysis patients didn't choose kidney disease, but now they are forced to endure hours of treatment every week and are at risk of losing their insurance coverage.

Get involved: Watch and listen to the patients fighting to protect their family's choice of health coverage.

Learn more.

 

Thanks for reading, and thanks to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits. Did someone forward this email to you? Here's how to sign up.

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