THE PROGNOSIS

The Trump administration has put its own health officials in a hugely awkward situation by refusing to defend a health-care law whose core components are critical to implementing some of their top public health initiatives.

Nowhere is this dichotomy starker than with the nation’s opioid abuse epidemic.

Brett Giroir — the assistant secretary for health at the Department of Health and Human Services who has been heading the agency’s efforts on opioid abuse — was eager yesterday to list some promising metrics on curbing substance abuse, telling me there’s an increasing supply of data showing overdose deaths have stopped rising, use of medication-assisted treatment is up and opioid prescribing is down.

“I think these things are all coming together,” Giroir said in a phone interview. “It’s really tremendous. We need to keep moving in that direction.”

But Giroir and his boss, HHS Secretary Alex Azar, are working within an administration that now fully backs an effort by GOP-led states to convince the courts to erase all of Obamacare — not only its protections for patients with preexisting conditions but also its expansion of health coverage through Medicaid expansion and federally-subsidized private marketplaces. The decision reflects a push by Mick Mulvaney, a former conservative firebrand member of Congress who now leads the White House Office of Management and Budget, The Post's Josh Dawsey, Ashley Parker and Damien Paletta report.

A decision overturning the ACA would endanger the agency’s anti-opioids effort by leaving around 25 million Americans without health coverage and removing the law’s requirements for insurers to cover substance abuse services as part of 10 essential health benefits.

Expanding treatment to people is difficult if they can’t afford it, and the affordability problem would undoubtedly worsen were Obamacare to be struck down without any replacement ready to go. Yet Trump and DOJ have more firmly entrenched their stance against the health-care, against reported urging by some within the administration.

“This is a fresh thing that occurred yesterday and I have not been able to review,” Giroir told me, when I asked him whether he’s concerned about the court challenge. “No one has briefed me on the alternative proposal that would take the place of the ACA.”

Giroir quickly pivoted to talking about the need for medication-assisted treatments such as methadone, buprenorphine and naltrexone. These medications have proven to be highly effective for patients struggling with addiction and are often stressed by Azar as crucial to HHS’s goals of reducing the country’s overdose deaths at least 15 percent by January 2021.

“If the ACA were replaced, I would certainly advocate for programs that broaden access to that, because it’s critically important for opioid use disorder,” Giroir said.

I asked whether he’d been able to communicate any concerns about the ACA lawsuit to Azar or the White House. “I think Secretary Azar is fully aware of the need to have people on medication-assisted treatment and to have access to medications,” Giroir responded.

The new Justice Department notice saying it won’t defend any of the ACA against a challenge from Texas and several dozen other states has renewed a heated health-care debate on Capitol Hill, one that particularly advantages Democrats. They eagerly jumped on DOJ for backing even further away from Obamacare, after the department had initially opposed only the law’s protections for people with preexisting conditions.

Top Senate Democrat Chuck Schumer announced yesterday that he’ll try to force a vote on a measure prohibiting DOJ from using any funding to “litigate the downfall of the ACA.”

“Let’s see if all of our Republican colleagues who have said they don’t want to take away protections for preexisting conditions,” Schumer told reporters. “Let’s see how our Republican colleagues will vote on this.”

The Post's Erica Werner:

The Washington Examiner's Kimberly Leonard:

The administration’s latest position on the ACA lawsuit – slammed by legal scholars across the political spectrum – has highlighted a schism between Trump and members of his administration as well as GOP leaders in Congress

In the last two days, the president has called a handful of senators to pressure them to come up with a GOP replacement to Obamacare — even though the party failed to coalesce around a plan when it controlled the House and Senate for two years, The Post's Rachel Bade, Josh Dawsey, Seung Min Kim and John Wagner report. Trump spoke with Sen. David Perdue (R-Ga.) on Tuesday evening and listed his priorities in a phone call with Sen. John Barrasso (R-Wyo.) on Wednesday morning, they write.

“If the Supreme Court rules that Obamacare is out, we'll have a plan that is far better than Obamacare,” Trump told reporters at the White House yesterday.

Capitol Hill Republicans, on the other hand, have been avoiding the topic like the plague. House Minority Leader Kevin McCarthy (R-Calif.) urged Trump against the legal move, Rachel, Josh and John report.

“The unheeded counsel, which McCarthy recounted to fellow lawmakers in recent days, underscores the angst that has set in among Republicans now that Trump is pursuing the politically precarious strategy with no plan in hand to replace Barack Obama’s signature health-care law,” my colleagues write.

ABC News Correspondent Karen Travers:

CNN's Manu Raju:

MSNBC producer Kyle Griffin:

Fox News's Chad Pergram:

Bloomberg reporter Steven Dennis:

The Post's Paul Kane:

Even setting all the legal and political questions aside, it’s clear the administration’s position has the practical effect of undermining Trump’s promise a year and a half ago to stem the opioid epidemic. Tomorrow marks one year since Giroir was appointed to lead the effort, and while it’s not clear the overdose death rate is markedly receding, Giroir says he’s still encouraged by some promising data.

He told me that in the last two years, the monthly number of people getting buprenorphine has increased 27 percent and pharmacies are dispensing 28 percent fewer milligrams of opioids. He also said prescriptions of naloxone, a highly effective overdose-reversing drug, have increased 534 percent in the same time period.

“The mortality curve has flattened,” he said. “We are very metric-driven because we have to know how we’re doing.”

Congress and Trump’s opioids commission have provided HHS with plenty of things to keep Giroir and staff busy. The opioids commission, headed by former New Jersey Gov. Chris Christie, released a set of recommendations in Nov. 2017, which Giroir said have been incorporated into HHS’s five-point strategy.

And an opioids measure passed by lawmakers last fall directs the agency to make a slew of changes oriented around expanding treatment to patients with substance abuse and fueling prevention efforts around the country.

“We literally have a 25-page spreadsheet of items we’re implementing,” Giroir said.

AHH, OOF and OUCH

AHH: Giroir, whose name has been floated as a possible successor to Food and Drug Administration commissioner Scott Gottlieb told The Health 202 he’s comfortable staying put. Giroir said he’s “100 percent fulfilled, satisfied, challenged and enriched” in his current role, when we asked whether he’ll be nominated as the next FDA commissioner. Besides leading the agency’s opioids effort, he’s also heading up an initiative to stem new HIV transmissions.

“I think my entire life and training has been for this type of public health job and I like what I’m doing now,” Giroir told Health 202 yesterday. “We’re ending HIV, we have the largest public health crisis in modern history with opioids and this is a challenge that I want and I think I’m the right person for this job.”

National Cancer Institute Director Norman “Ned” Sharpless will be the acting commissioner when Gottlieb leaves the post next month.

OOF: A federal judge has thrown a wrench in the Trump administration’s efforts to impose work requirements on low-income people on Medicaid, blocking the work programs in Kentucky and Arkansas.

In his ruling, U.S. District Court Judge James Boasberg said HHS’s approval of Kentucky’s requirements was “arbitrary and capricious,” which is the same criticism he directed at the state before, our Post colleague Amy Goldstein reports. The judge first rejected the Kentucky program in a June ruling, days before the rules were set to go into effect. 

While Kentucky was the first to win approval from the Trump administration to impose “community engagement” requirements, Arkansas was the first state to impose them. In the identical opinions, Boasberg said the rules in effect in Arkansas “cannot stand.”

About 18,000 people have lost Medicaid coverage so far there for failing to meet the standards, and as Amy reported earlier this week, one community “scarce on jobs and among the poorest in a poor state” provided an early glimpse of the difficulty of the Trump administration’s efforts."

Adam Meier, Kentucky’s health and family services secretary, stressed the “very narrow basis” of the ruling. He said Kentucky would work to “quickly resolve the single issue raised” in the ruling.

In statement, the top Democrat on the Senate Finance Committee Sen. Ron Wyden (D-Ore.) called the ruling a “victory for working families that were being crushed by mountains of burdensome and unnecessary paperwork designed to take away their health care." “There will be more work in the days ahead to ensure this ruling stands, but now it is clear that this cruel scheme is on the wrong side of the law,” he added.

Republican Rep. Steve Womack (R-Ark.) weighed in: 

From Sen. Richard Blumenthal (D-Conn.): 

Joan Alker, executive director of the Georgetown University Center for Children and Families

OUCH: More state lawmakers are trying to pass “heartbeat” bills that prohibit abortion as early as six weeks, once a fetal heartbeat is detected, in an effort to push the Supreme Court to revisit Roe v. Wade. Four states have already enacted such bills, and while many have already been blocked by courts, Politico’s Rachana Pradhan reports more states, including Georgia, are soon expected to enact bills.  

The growing number of heartbeat bills comes as an analysis from Planned Parenthood and the abortion-rights supporting Guttmacher Institute found the number of state legislatures introducing these abortion bans spiked in the last year, Rachana reports.

Lawmakers in 14 states introduced heartbeat bills this year, compared with eight at the same point last year. “In all, the heartbeat bills, which constitute some of the most restrictive abortion bans in the country, are among roughly 250 pieces of legislation across 41 states that aim to reduce access to the procedure,” Rachana writes. “Separately, six states — including Kentucky on Tuesday — have already enacted laws that would automatically ban abortion in the event that the Supreme Court strikes down Roe.”

Politico’s Alice Ollstein and Beatrice Jin also have an interactive out detailing 12 cases going through federal courts that could challenge abortion access under Roe v. Wade.

AGENCY ALERT

— The FDA has proposed requiring mammogram providers to tell women about breast density information, notifying them that dense tissue could make it harder to interpret mammograms, our Post colleague Laurie McGinley reports. The providers could also urge women to talk to their doctors about whether they need to get additional tests to check for cancer.

Nearly half of women age 40 and older who get mammograms find that they have dense breasts, which means there are relatively high amounts of glandular tissue and fibrous connective tissue and low amounts of fatty breast tissue.

“More than three dozen states have laws requiring women who have mammograms that the have dense breasts,” Laurie writes. “The new FDA language would establish a minimum standard that would apply nationwide.”

The FDA proposal would make changes to the rules under the 1992 Mammography Quality Standards Act, which sanctioned federal oversight of the more than 8,000 facilities that perform mammograms in the United States.

HEALTH ON THE HILL

— Rep. Lisa Blunt Rochester (D-Del.) led a group of Democratic lawmakers on the House Energy and Commerce committee who sent a letter to Azar and Centers for Medicare and Medicaid Services Administrator Seema Verma urging them to release documents related to a study of ACA outreach and marketing efforts.

The Delaware Democrat said in a statement the administration is “suppressing” an internal study that points to the “success and cost-effective results from ACA marketing.”

“If we are to stabilize the Affordable Care Act, we need to take a 360-degree approach that revisits the cost of prescription drugs, how we incentivize new states to establish state-based markets, and how we attract younger, healthy people to sign up and get covered,” she said. “That’s why it is alarming that new documents and testimony have come to light that reveals that CMS is suppressing an internal, multi-year study highlighting the success and cost-effective results from ACA marketing. This deceptive act is another in a long line from the Administration to slowly undermine strength and trust in our health care system, and we cannot let that stand.”

The letter was also signed by House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.), health subcommittee chairwoman Anna Eshoo (D-Calif.) and 28 others.

INDUSTRY RX

— Novartis AG is planning to introduce a new multiple sclerosis medication next week that is less expensive than its previous version of the drug.

The new drug, Mayzent, will cost $88,500 a year, which is more than 7 percent lower than the decade-oil Gilenya pill it will replace, Bloomberg’s Naomi Kresge and James Paton report. “It’s the second recent case of a new multiple sclerosis medicine being priced below older therapies: Roche Holding AG introduced Ocrevus in 2017 at a 25 percent discount to an older drug it bested in clinical tests,” they add.

The announcement comes as drugmakers have faced mounting political pressure over the skyrocketing cost of prescription drugs.

“But in the long term, the biggest challenge facing new medicines like Mayzent may be market dynamics, not politics,” Naomi and James report. “Three popular multiple sclerosis pills -- including Novartis’s warhorse Gilenya -- are due to face generic competitors within the next five years.”

—  A jury in New Jersey unanimously cleared Johnson & Johnson of responsibility in a lawsuit brought by a man who alleged the company’s talcum powder had caused his cancer.

So far the company has faced 12 trials over claims that asbestos in their products caused mesothelioma, and the company has been cleared of liability in four trials, Reuters’s Tina Bellon reports. Five other trials resulted in mistrials or hung juries while three juries found the company liable, verdicts Johnson & Johnson is now appealing.

The company is facing about 13,000 lawsuits related to its talcum-based products. It “denies that its talc causes cancer, saying numerous studies and tests by regulators worldwide have shown its talc to be safe and asbestos-free,” Tina writes. “J&J in a statement said the company’s track record in the talc litigation underscored ‘the decades of clinical evidence and scientific studies by medical experts around the world’ supporting the safety of Johnson’s Baby Powder.”

— Walgreens is the latest drugstore chain to announce it will sell cannabis-based products in some of its stores, following a move by CVS Health earlier this month.

The company said it will sell cannabidiol products, or CBD products, in about 1,500 stores in, Colorado, Illinois, Indiana, Kentucky, New Mexico, Oregon, South Carolina, Tennessee and Vermont, CNBC’s Angelica LaVito reports. Last week, CVS health announced certain CBD products will be sold in 800 stores in eight states.

“Consumers are increasingly curious about CBD, which promises to help everything from anxiety to pain even though there is scant evidence backing up these claims,” Angelica writes. “And while CBD derived from hemp is now legal thanks to the farm bill Congress passed late last year, the FDA says companies still can’t add CBD to food or sell it as a dietary supplement.”

— And here are a few more good reads: 

TRUMP TEMPERATURE
Health
Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding of the risks — which includes a rare cancer that is linked to several deaths around the world — posed by the devices.
Laurie McGinley
MEDICAL MISSIVES
How a baby's unexpected death is investigated can heighten parents’ self-blame even when there’s no evidence of wrongdoing.
Stat
A U.S. government pediatrician convicted of sexually abusing Native American boys under his care is still receiving his government pension. Records indicate he is due more than $1.8 million during his prison term.
Wall Street Journal
The jury determined the popular weed killer was a "substantial factor" in the development of a California man's non-Hodgkin’s lymphoma.
BuzzFeed
STATE SCAN
Maryland Politics
Proposal to allow doctors to help terminal patients end their lives falls just short of passage after years of effort.
Ovetta Wiggins
The Ohio Senate passed Senate Bill 23, which bans abortions when a fetal heartbeat is detected, largely along party lines.
Cleveland.com
The collapse of an effort to legalize marijuana in New Jersey revealed the thorny and knotty difficulties in trying to legalize marijuana.
New York Times
DAYBOOK

Today

  • Politico hosts an event on "Opioid Misuse, Hepatitis C and HIV." 
SUGAR RUSH

Members of the House sang 'Happy Birthday' to House Speaker Nancy Pelosi (D-Calif.) as she turned 79 this week: