Overnight Health Care — Presented by The Partnership for Safe Medicines — Juul halts retail sales for most flavored e-cigs | CDC confirms 90 cases of rare polio-like illness | Physicians push back on Trump plans to redefine gender

by Nathaniel Weixel, Jessie Hellmann and Peter Sullivan - 11/13/18 8:36 PM ET

Welcome to Tuesday’s Overnight Health Care

It’s been a busy news day on the health care front. Cases of a rare polio-like disease are still rising, the Trump administration is loosening restrictions on Medicaid coverage of mental illness, a drug pricing group wants to hold Congress to their word, and the Department of Veterans Affairs is under pressure to implement a massive new law overhauling how patients can seek care.

We’ll start with news from e-cigarette startup Juul:

Juul halts retail sales for most flavored e-cigarettes amid federal pressure

In an effort to get out ahead of incoming FDA regulations, e-cigarette maker JUUL on Tuesday announced that it would stop selling certain flavor pods in all retail locations.

The company also said it would curb its presence on social media.

“As of this morning, we stopped accepting retail orders for our Mango, Fruit, Creme, and Cucumber JUUL pods to the over 90,000 retail stores that sell our product, including traditional tobacco retailers (e.g., convenience stores) and specialty vape shops,” Juul CEO Kevin Burns said in a statement.

“By deterring social media promotion of the Juul system by exiting our accounts, we can better prevent teens and non-smokers from ever becoming interested in the device,” he added.

Actions Juul is taking: Mango, Fruit, Creme and Cucumber flavors must now be purchased on the company’s website, where additional age-verification measures are being added. The company also said that it will shut down its Facebook and Instagram accounts, and has asked Facebook, Instagram, Twitter and Snapchat to prohibit the posting of any content that promotes the use of cigarettes or e-cigarettes by underage users.

“We don’t want anyone who doesn’t smoke, or already use nicotine, to use Juul products. We certainly don’t want youth using the product. It is bad for public health, and it is bad for our mission,” Burns said.

Will it be enough? FDA is preparing a serious crackdown on Juul and other e-cigarette makers for what he’s said is an “epidemic” of youth vaping. While Burns said Juul wants to cooperate, FDA Commissioner Scott Gottlieb indicated the regulations are still coming.

“We’re deeply concerned about the epidemic of youth use of e-cigs. Voluntary action is no substitute for regulatory steps #FDA will soon take,” he said in a tweet. “But we want to recognize actions by JUUL today and urge all manufacturers to immediately implement steps to start reversing these trends.”

Read more here.

CDC confirms 90 cases of rare polio-like illness affecting children in 27 states

The Centers for Disease Control and Prevention (CDC) on Tuesday confirmed 90 cases of a polio-like illness in 27 states.

The CDC is still trying to determine what triggers Acute Flaccid Myelitis (AFM), which causes limb weakness and primarily affects young children.

“As a mom, I know what it’s like to be scared for our children and I understand parents want answers,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said in a press call with reporters Tuesday.

Of the confirmed cases, most patients are between the ages of two and eight.
The CDC is investigating 252 cases, an increase of 33 patients since last week. The investigation includes the 90 confirmed cases.
Most patients have fevers and or respiratory system infections three to 10 days before experiencing limb weakness.

Context: The CDC is still unsure of what triggers someone to develop AFM.

“We’ve learned a lot about AFM since 2014, but there are still things we don’t understand,” Messonnier said.

Read more here.

GOP chairman ‘assessing’ Trump’s drug pricing move

President Trump made his most aggressive move yet to target high drug prices last month when he announced a proposal to tie some drug prices in Medicare to the lower prices in other countries.

The move is a sharp departure from GOP orthodoxy on letting the market play out in drug prices.

So how does GOP Rep. Kevin Brady (R-Texas), the chairman of the Ways and Means Committee, feel about it? We asked him at a press availability on Tuesday.

He is not weighing in, saying only that he’s still “assessing” the proposal.

The politics: Congressional Republicans might not want to publicly break with President Trump on this issue, even if it’s not what they exactly want to do.

Drug pricing group launches six-figure ad buy pressuring Congress to act

Hopes are high for action on drug pricing next year with a Democratic House and President Trump highlighting the issue.

And a leading advocacy group, the Campaign for Sustainable Rx Pricing, is launching a new six-figure ad buy to keep the pressure on.

The ad shows a man writing a letter to Congress, saying, “Drug prices are going up, every single day. It’s price gouging. When will you take action?”

“Congress: You promised lower drug prices. Keep your commitment,” the ad ends.

What do they want? The Campaign for Sustainable Rx Pricing, a coalition of insurers, hospitals, and other groups, is pushing for ideas like easing approvals of cheaper generic drugs to increase competition, and increasing transparency around drug costs.

Democrats are pushing to go further and enact ideas like allowing Medicare to negotiate drug prices.

Read more here.

Physicians push back on Trump plans to redefine gender

The American Medical Association (AMA) is pushing back against a potential new policy from the Trump administration that could eliminate federal protections for transgender individuals.

The country’s largest physician lobbying group said Tuesday during its interim meeting that it will “oppose efforts to deny an individual’s right to determine their stated sex marker or gender identity.”

“It is essential to acknowledge that an individual’s gender identity may not align with the sex assigned to them at birth,” AMA board member William E. Kobler said in a statement. “A narrow limit on the definition of sex would have public health consequences for the transgender population and individuals born with differences in sexual differentiation, also known as intersex traits.”

AMA’s stance comes just weeks after a news report that the Department of Health and Human Services is spearheading an effort to narrowly redefine sex as “a person’s status as male or female based on immutable biological traits identifiable by or before birth.”

Read more here.

Trump administration loosens restrictions on mental health treatment

The Trump administration is loosening restrictions to allow states to better treat patients with serious mental illnesses.

Health and Human Services Secretary Alex Azar wants states to apply for waivers to allow Medicaid to pay for long term mental health at inpatient facilities. The waivers have previously been used to provide more flexibility on substance use disorders.

“Different forms of treatment work for different patients, but the decades-old restriction on Medicaid reimbursement for inpatient treatment at institutions for mental diseases, or IMDs, has been a significant barrier,” Azar said Tuesday during a speech to the National Association of Medicaid Directors.

The initial exclusion was meant to phase out the use of psychiatric wards by preventing Medicaid from paying for treatment in facilities with more than 16 beds. States were responsible for the care of people with severe mental illness in those facilities.

But as the opioid epidemic has worsened, people suffering from serious addiction have not been able to find appropriate residential treatment and instead many wind up in emergency rooms.

The waivers would let Medicaid pay for patients with severe mental illness for an average of 30 days, similar to the substance abuse waivers that have been granted in 17 states.

Read more here.

VA under pressure to deliver Trump reforms

A law overhauling how the Department of Veterans Affairs (VA) allows patients to seek outside care is falling behind in implementation despite President Trump’s boasts about the reforms.

Trump has long touted the law, which makes it easier for veterans to access private or community health-care programs, as essential to improving the beleaguered agency.

The law, signed in June, allows for a yearlong implementation period, and veterans say they would rather it be done right than hastily.

Veterans groups are watching the process intently, and the VA is under pressure to implement the new law in time.

The law in question, the VA Mission Act, is the replacement to the VA Choice Act, a program first established in 2014 during the Obama administration. The Choice program was created after the VA wait-time scandal where administrators were found to be doctoring appointment schedules to cover up problems providing veterans health care.

The Choice program gives veterans facing long wait times at the VA or who would have to travel far to reach a VA facility the ability to seek private health care paid for by the government. About 30,000 appointments per day are funded through the Choice program.

We looked into the challenges facing the VA here.