THE PROGNOSIS

Congress has provided billions of new dollars to fight opioid abuse. But the problem will be far from solved when the one-time appropriations run out next year.

President Trump and Health and Human Services Secretary Alex Azar announced $1.8 billion in grants last week to help states increase access to medication treatment and mental health care for those struggling with addiction. It’s part of a new infusion of funding — passed by Congress one year ago — aimed at the epidemic that kills tens of thousands of Americans every year.

“By the end of this month, HHS will have awarded a record $9 billion to expand access to prevention, treatment and recovery services to states and local communities during my administration,” Trump said. “And they’re doing a great job locally when they get the funds … and great results.”

But here’s the catch: States use much of the funds to help uninsured people who don’t have a way to pay for their treatment. When the dollars run out, treatment could be once against beyond the reach of these patients if they don’t find a long-term way to pay for care through insurance.

“It doesn’t inspire a lot of commitment to see these grants are just a year and they may or may not go away,” said Anand Parekh, chief medical adviser for the Bipartisan Policy Center, which released a report in March analyzing the dozens of federal funding streams for opioid addiction and how states are using the money.

It’s a particularly pressing problem in states that didn’t expand their Medicaid programs, such as North Carolina, where more than 10 percent of its population lacks coverage.

North Carolina has received $75 million in new federal grants, said Susan Kansagara, chronic diseases section chief at the state’s Department of Health and Human Services. The grants have allowed the state to supply about 10,000 people with treatment. But there’s no guarantee they’ll continue getting the treatment once those funds are gone, considering North Carolina has one of the country’s highest uninsured rates.

“We have a huge population of uninsured that can receive treatment from these funds, but how are they going to continue to receive treatment?” Kansagara said. “We know [opioid abuse] is a condition that requires many years, if not a lifetime, of treatment and recovery support.”

She added: “It’s hard to tell, for example, a practice to hire two more physicians if I don’t now if funding is going to continue to come in after two years.”

It’s hard to overstate Medicaid’s role in helping mitigate the opioid crisis. The program for the low-income was the expected payer for 37 percent of opioid-related hospital stays and 44 percent of emergency department visits in 2016. About 17 million additional Americans joined the program when many — but not all — states expanded it under the Affordable Care Act.

“Without expansion, you’re missing a fundamental tool that can address the epidemic,” said Jocelyn Guyer, managing director of Manatt Health, a consulting firm.

But even states with this “tool” of Medicaid expansion are struggling to figure out the best way to direct the funding. “The one- to two-year challenges are very much apparent,” said Kate Harris, chief deputy commissioner at the Colorado Division of Insurance.

Tackling the opioid crisis, which has reached across the United States and prompted a public health emergency declaration by Trump, is far from simple, involving a patchwork of stakeholders and approaches.

States and localities are suing opioid makers to help pay for treatment. Mallinckrodt Pharmaceuticals, one of the largest manufacturers of generic opioids, announced last week it has agreed on a settlement in which it will pay two Ohio counties $24 million in cash and donate $6 million in drugs, including for addiction treatment medications.

Officials have recently clashed over how to even pursue damages. Ohio Attorney General Dave Yost has sued to halt a landmark trial in October, part of a consolidation of thousands of opioid lawsuits brought by local governments. Yost charges that the Ohio counties involved in the case are trying to seize potential payments from the opioid makers that could be better used by the state.

And then there’s the money coming to states from the federal government, both from last year’s Support Act and two pieces of legislation President Obama signed in 2016 to address the epidemic. In analyzing those two measures, Parekh and his colleagues identified 57 different federal funding streams across six executive branch departments, a complex web he said makes coordination difficult for states trying to put all the funds to best use.

Doctors, who have borne much blame for leading to the crisis by overprescribing opioid painkillers, are offering states advice of how to best use the dollars. Yesterday the American Medical Association released six recommendations on how states should direct the funding.

The recommendations include removing barriers to medication-assisted treatment, ensuring private health plans cover mental health services in accordance with the law, expanding alternative to opioids for managing pain and making naloxone, the overdose-reversing drug, more readily available.

“We have to think about building an infrastructure to address this epidemic,” Harris told reporters.

It would be up to Congress to extend the opioid funding beyond next year. The Trump administration hasn't said whether it's asking lawmakers to do so. 

“If I could, I would,” Elinore McCance-Katz, director of the Substance Abuse and Mental Health Services Administration, recently told the New York Times.

AHH, OOF and OUCH

AHH: House Speaker Nancy Pelosi (D-Calif.) is expected to release an ambitious drug-pricing bill that would enable Medicare to directly negotiate prices on the 250 most expensive drugs without at least two competitors. That price would then be available to all consumers, not just Medicare beneficiaries, our colleague Yasmeen Abutaleb reports, based on a summary of the bill obtained by The Post.

Pelosi is expected to release the new proposal this week or next. While the Democrat-led House is expected to pass it, it will be blocked by the GOP-led Senate. At that point, Pelosi would have to negotiate with President Trump on legislation that could pass both chambers.

“The House bill is a political marker for Democrats eager to show ahead of the 2020 presidential and congressional elections that they are willing to take significant measures to lower skyrocketing drug prices, which consistently poll as a top voter concern,” Yasmeen writes. 

Under the proposal, drugmakers that don’t reach an agreement with the Health and Human Services Secretary or that refuse to negotiate will be penalized. The bill would also use an international pricing index to make sure U.S. consumers don’t pay more than beneficiaries in other countries.

Pelosi “put forward a more progressive bill than anticipated and one she knows is dead on arrival in the Senate," Chris Meekins, a research analyst at Raymond James and former Health and Human Services official told Yasmeen. "This proposal reiterates our belief that nothing on drug pricing will be done before the 2020 election," he said.

OOF: Amid a continued national uproar over the safety of e-cigarettes, the Food and Drug Administration penned a harsh letter to Juul Labs, chastising the company for illegally pitching its e-cigarette products as safer than regular cigarettes, our Post colleague Laurie McGinley reports. FDA said it acted after reviewing congressional testimony where Juul was accused of targeting children and teenagers in sophisticated ways as part of an effort to become the nation's largest seller of e-cigarettes.

In the warning letter, the FDA said Juul’s testimony revealed it marketed its products as “modified risk tobacco products.” Under federal regulations, such products must be authorized by the agency, but the FDA said that without obtaining this authorization, Juul was selling “adulterated” products. A Juul spokesman said the company plans to “fully cooperate” with the FDA.

In a second letter, the FDA also called for additional information about Juul’s marketing practices that were detailed during congressional hearings. The agency also wants an explanation for the company’s use of nicotine-salt e-liquids and high concentrations of nicotine in the Juul pods which could increase the products’ addictive qualities, Laurie reports.

— Billionaire businessman Michael Bloomberg announced he will spend $160 million over three years from his philanthropy to ban flavored e-cigarettes in an effort to combat youth vaping, Laurie reports.

“E-cigarette companies and the tobacco companies that back them are preying on America’s youth,” Bloomberg said in a statement. “The result is an epidemic that is spiraling out of control and putting kids in danger of addiction and serious health problems.”

The funding will be used to push local, state and federal governments to ban flavored e-cigarettes; help local and state governments if they face industry challenges on banning e-cigarettes; and to push the FDA to more aggressively review and regulate such products. Some states are already moving, Laurie writes.

"On Monday, New York Gov. Andrew M. Cuomo (D) announced plans to propose legislation to bar the possession, manufacture, sale and distribution of flavored e-cigarettes,” she writes. “Michigan has already announced plans to bar the products on an emergency basis.”

OUCH: New York Gov. Andrew Cuomo (D) is ordering the state's health department to subpoena three companies selling substances linked to the unusual spate of vaping-related lung illnesses across the country, our Post colleague Lena H. Sun reports.

These companies are marketing and selling thickening agents used in illicit vaping products that contain THC, the component in marijuana that makes users high. The agents are being pitched as a “cheaper, safer alternative that does not negatively impact flavoring or odor of existing products and can be used to cut vape products to any level of THC,” Cuomo’s office said in a news release.

“New York state’s lab obtained samples of thickeners from three companies and determined they are ‘nearly pure’ vitamin E acetate, an oil derived from vitamin E,” Lena writes. “Federal and state authorities have identified vitamin E acetate as a potential clue in the unfolding mystery because it is a common element in cannabis products that have been collected from patients who have fallen ill.”

There are now 450 possible cases of the mysterious lung illness in 33 states and one territory. 

Cuomo’s office said the three companies — Honey Cut Labs in Santa Monica, Calif.; Floraplex Terpenes in Ypsilanti, Mich.; and Mass Terpenes in Amherst, Mass. — are the first to be subpoenaed but that more firms “are likely to be ordered to provide samples as the investigation continues. Health authorities want the companies to provide additional information to aid the ongoing investigation," Lena writes. 

TRUMP TEMPERATURE

— The White House is considering studying mentally ill individuals to identify risk factors that could help stop mass shootings. The proposal would explore whether technology such as phones and smartwatches can be monitored to determine when those with mental illnesses are about to turn violent.

The plan is part of a broader proposal for a new research agency that's been pitched to top officials including Trump and Vice President Pence and Ivanka Trump by former NBC chairman Bob Wright, a longtime Trump friend and associate. Wright proposed creating a "new research agency called HARPA to come up with out-of-the-box ways to tackle health problems, much as DARPA does for the military, say several people who have briefed,” our Post colleague William Wan reports.

“After the recent shootings in El Paso and Dayton, Ivanka Trump asked those advocating the new agency whether it could produce new approaches to stopping mass shootings," he writes. So Wright's advisers put together a proposal for the violence detection plan. 

It’s a proposal that has alarmed some experts who point to civil liberty concerns as well as concerns about the technology prompting false flags. “I would love if some new technology suddenly came along that would help us identify violent risk, but there’s so many things about this idea of predicting violence that doesn’t make sense,” said Marisa Randazzo, former chief research psychologist for the U.S. Secret Service.

— Pressure is already ramping up on for lawmakers to act on gun legislation as they return from their August recess. A leading anti-gun-violence organization released a video yesterday that featured eight Democratic presidential candidates calling for action on the issue, though the video pushes no specific gun policy.

The nearly 90-second clip features, in order, Sen. Elizabeth Warren (Mass.); former congressman Beto O’Rourke (Tex.); South Bend, Ind., Mayor Pete Buttigieg; Sen. Cory Booker (N.J.); Sen. Kamala D. Harris (Calif.); Sen. Amy Klobuchar (Minn.); Sen. Bernie Sanders (I-Vt.); and former vice president Joe Biden.

It's the first in a series of videos planned by Giffords, the group founded by former congresswoman Gabrielle Giffords (D-Ariz.), our Post colleague John Wagner reports.

AGENCY ALERT

— The National Institutes of Health has launched an investigation into management and personnel issues at a troubled pharmacy at its renowned clinical and research center, and removed four senior officials there, our Post colleague Lenny Bernstein reports.

“Unlike a leadership shake-up at the 200-bed Clinical Center that followed reports of contaminated drugs in 2015, this investigation does not appear to involve patient safety problems in the pharmacy, which prepares drugs for patients treated at the hospital,” he writes. “Rather, it focuses on complaints against managers and a difficult workplace culture.”

At a meeting on Friday, James Gilman, the center’s chief executive, told pharmacy employees that the investigation focuses on allegations of “potentially discriminatory and inappropriate conduct in the pharmacy,” according to a recording of the meeting.

“The issues are very clear,” Gilman told staff. “We have trouble keeping staff. Too many good people have left. Too many good people that we wanted to come didn’t, because they’re not sure it’s a good place to work.”

“The inquiry, which must be completed within 120 days, is being conducted by the NIH Civil Program, which is part of its Office of Human Resources,” Lenny reports. “On its website, the Civil Program urges employees to contact the program if they ‘become aware of a workplace situation involving uncivil behavior, such as harassment, sexual harassment, inappropriate conduct, intimidation, bullying or other unproductive, disruptive, and/or violent behaviors.’”

REPRODUCTIVE WARS

— A pair of Planned Parenthood clinics in Cincinnati are closing after they refused federal family planning dollars amid new restrictions from the Trump administration prohibit recipients from providing abortion referrals.

The announcement follows Planned Parenthood’s move to withdraw from the Title X federal family planning program over the new restrictions. The Sept. 20 closure of the two Cincinnati locations — neither of which performs abortions — will leave five clinics open and operating in the greater Cincinnati and Ohio Valley regions, ABC News’s Meghan Keneally reports.

“These closures are the result of years attacks on our ability to provide reproductive health care. Ohio politicians have passed 22 anti-reproductive health measures in recent years, including a defunding bill that went into effect earlier this year,” Kersha Deibel, president and CEO of Planned Parenthood Southwest Ohio Region said. “Then came the changes to the Title X program, from an administration that has made it clear that it wants to force out trusted health centers that provide evidence-based, comprehensive reproductive health care.”

— And here are a few more good reads from The Post and beyond: 

HEALTH ON THE HILL
The Fix
Republicans are willing to have a conversation about guns, but it’s not clear there’s enough political pressure for them to actually pass new gun laws
Amber Phillips
Politics
House Speaker Nancy Pelosi and Senate Minority Leader Charles E. Schumer want the Senate to vote on a House-passed bill expanding background checks.
Mike DeBonis
The Vermont senator has staked his presidential campaign, and much of his political legacy, on transforming health care in America. His mother’s illness, and a trip he made to study the Canadian system, help explain why.
New York Times
OPIOID OPTICS
A group of state attorneys general negotiating with members of the Sackler family says they expect Purdue Pharma to file for bankruptcy "imminently," according to an email obtained by NPR.
NPR
The OxyContin maker argues it was a small player in the prescription pain pill market, but a ProPublica analysis shows it had a far bigger impact.
Stat
MEDICAL MISSIVES
Business
The 80 topics that will be covered do not include key issues such as the health effects of the consumption of red and processed meat, the dramatic increase in ultra-processed foods and sodium levels.
Laura Reiley
Health
Over six years, the public institution took people to court more than 36,000 times, an analysis finds.
Jay Hancock and Elizabeth Lucas
INDUSTRY RX
The move comes amid an ongoing uproar over the way Novartis recently disclosed manipulated data, which has cast a pall over the drug maker.
Stat
Data including when women last had sex was sent to Facebook and other third-party services, according to new research shared exclusively with BuzzFeed News.
BuzzFeed
DAYBOOK

Today

  • The House Energy and Commerce Subcommittee on Health holds a hearing on improving maternal health.
  • The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on holds a markup.
  • The Senate Joint Economic Committee holds a hearing on making it more affordable to raise a family.

 Coming Up

  • The House Small Business Committee holds a hearing on barriers to care and burdens on small medical practice on Wednesday.
SUGAR RUSH

Trump keeps joking about serving more than two terms as president: