THE PROGNOSIS

Turns out the proposal from the Trump administration to require drug prices be revealed in television ads might be more showbiz than anything else. But that doesn’t mean the powerful pharmaceutical industry will comply without a fight.

Drugmakers and federal health officials started to spar on Monday after the latter unveiled a a rule requiring companies to list in text at the end of their ads the price for a 30-day supply or typical course of treatment of the drug they’re trying to sell.

Alex Azar, secretary of the Department of Health and Human Services, billed the move as a major triumph for President Trump, who with his drug pricing blueprint released last spring has vowed to take on the industry and its skyrocketing charges for medications.

“President Trump is taking historic action to bring patients more transparency through consumer advertising,” Azar said in a late-afternoon address to the National Academy of Medicine.

“Sometimes markets evolve on their own, but sometimes it takes government to make the first move, to disrupt a broken system and to lay down new rules of the road,” he said. “You’ve heard today we’re willing to do just that. We will not wait for an industry with so many conflicting and perverse incentives to reform itself.”

(My colleagues Amy Goldstein and Carolyn Y. Johnson have more on the proposed rule here.)

If Azar is seeking to appear at odds with the pharmaceutical industry, he sure notched a win. But it’s a war he could ultimately lose.

Pharmaceutical Research and Manufacturers of America, the industry’s main trade association, tried to preempt Azar’s speech with its own announcement Monday morning, saying its 33 member companies will start making more pricing information available to consumers — but in a way PhRMA says is more helpful than what HHS is proposing.

Under PhRMA’s approach, ads will direct viewers to a website where they can view not just the price of a medicine but also additional information, such as a patient’s typical out-of-pocket costs for the drug or device. Because most patients don’t pay the actual list price of a drug, it’s much more helpful to give them an idea of how much a drug could cost them directly, PhRMA chief Steve Ubl told reporters yesterday.

Besides, as Ubl’s argument went, merely telling people the list price of a medicine — typically a much higher number paid by the insurer — could discourage customers from buying the medication for fear of being charged excessively.

“We think putting the list price in isolation in the ads themselves is very confusing and misleading and isn’t what patients want or need,” Ubl said.

Ubl may have a point here. Many consumers wouldn’t necessarily benefit from viewing list prices in drug ads. It's true that consumers who have health insurance typically don’t pay the full price for their medications. Neither do insurers, for that matter, since they often negotiate lower prices with drugmakers.

Azar — whose move was applauded by health insurers and doctors — argued that list prices are still relevant to some people, such as seniors on Medicare required to pay a percentage of the list price (known as coinsurance) for specialty drugs, or younger Americans with a high-deductible health plan. He charged that the pharmaceutical industry’s new plan doesn’t go nearly far enough.

But the effectiveness of listing prices in ads isn’t the most immediate question. What’s more pressing is whether the federal government has the legal authority to require the listing of drug prices at all. Existing statute indicates it may not, which means HHS could be facing some lawsuits pretty quickly.

“There’s lots of evidence in the law right now that FDA doesn’t have this authority,” Coleen Klasmeier, who worked as an attorney for the Food and Drug Administration during the George W. Bush administration, told me.

Of course, it’s not the FDA proposing this new rule. It’s the Centers for Medicare and Medicaid Services. Which leads us to another strange thing about the administration’s move — and why it might be more about looking tough on the drug industry rather than actually cracking down.

You might have expected the administration to issue the rule through the FDA, the part of HHS that actually regulates drugs. But that’s not what Azar did.

Instead, it’s CMS that has proposed the rule, even though that department oversees the government’s health insurance programs, not drug companies themselves. The administration is relying on its authority to administer Medicare and Medicaid to require the price disclosures on the drugs these programs pay for. CMS Administrator Seema Verma has helped put in place several of the White House’s priorities around the Obamacare marketplaces and Medicaid.

Ubl charged that te action by CMS and not the FDA proves the government knows it’s overstepping its boundaries.

“It appears the proposed rule is being released by CMS and not FDA, which might be in and of itself telling,” Ubl said. “The administration realizes the FDA doesn’t have the authority to regulate in this area.”

Klasmeier told me that it’s clear from FDA statutes and regulations that lawmakers and policymakers have considered the agency’s role in regulating drug advertising – and never has it been deemed able to mandate pricing disclosures.

Now, there’s plenty the FDA can require. The agency can — and does — require companies to engage in what lawyers call “fair balance,” which simply means that if a drugmaker is advertising a medicine’s benefits, it must also disclose its drawbacks. That’s why you hear that long recitation of possible side effects at the end of ads for pharmaceutical products.

But it would take “magical thinking” to assertthe FDA could go so far as to mandate the inclusion of list prices in drug ads, Klasmeier said.

FDA Commissioner Scott Gottlieb, who enjoys more public favor than some in the Trump administration, tweeted his support of the proposed rule:

Sridhar Tayur, professor of operations management at Carnegie Mellon’s Tepper School of Business, said he views the CMS proposal as more of a symbolic way to pressure on the pharmaceutical industry since the agency is the country’s largest health-care payer through the Medicare and Medicaid programs.

“CMS can play the role of a very important customer,” Tayur told me. “It’s not a constitutionality issue as much as a large consumer saying, ‘Do you want my business or not?’ ”

LAUNCH DAY: Read Jacqueline Alemany’s first edition of Power Up, where she talks to the White House political operation about the anger roiling the electorate before the midterm elections. Jackie’s newsletter will land in inboxes every day at 5:30 a.m. topped with the freshest news driving events in Washington.

Don’t miss out and sign up here: https://wapo.st/get_powerup

AHH, OOF and OUCH

AHH: Sen. Elizabeth Warren (D-Mass.) yesterday released a DNA test that suggests she has distant Native American ancestors, part of an effort to discredit Trump and others who have expressed doubt about her claims about her heritage.

Test results saying there is “strong evidence” that Warren has Native American heritage dating back six to 10 generations were first reported by the Boston Globe. “The DNA analysis, by Carlos D. Bustamante, a Stanford University professor, concludes that ‘the vast majority’ of Warren’s ancestry is European but that ‘the results strongly support the existence of an unadmixed Native American ancestor in the individual’s pedigree, likely in the range of 6-10 generations ago,’” The Post’s John Wagner writes.

Warren's effort to respond to Trump's ceaseless attacks is yet another signal of her intent to run for president in 2020. Our Post colleague Matt Viser wrote about the expansive Democratic campaign Warren has been building over the past six months. Matt also wrote that Warren’s persistence on this issue raises the question of how much Trump is driving the Democratic presidential contest.

Following the release of the DNA results, Warren and Trump sparred over the president’s July vow to donate $1 million to charity if she was proven to have Native American ancestry. The president initially denied that he had pledged to do that, but later said he would “only do it if I can test her personally.”

Trump tweeted about Warren this morning:

The Massachusetts senator had this to say last night:

But Warren’s report also sparked plenty of questions.

In a statement, the Cherokee Nation said a DNA test is “useless to determine tribal citizenship.”

Warren acknowledged that “DNA and family history has nothing to do with tribal affiliation or citizenship, which is determined only — only — by Tribal Nations.”

So what’s the science behind this test? White House counselor Kellyanne Conway dismissed Warren’s DNA test as “junk science.” But is it?

“Jennifer Raff, an assistant professor in the anthropology department at the University of Kansas, said the geneticist who analyzed Warren’s DNA is a prominent scholar in the field, and the method he used and the way he used it was appropriate,” our Post colleague Lindsey Bever reports. “Raff, who has read the report, said the geneticist looked at Warren’s chromosomes and was able to trace segments of them back to a Native American ancestor about six to 10 generations ago.”

“The approach he took was solid,” she said, “and I would trust these results. However, they only speak to ancestry, not tribal affiliation or identity as a Native American.”

OOF: Low-income people in states that have not yet expanded Medicaid are more likely to skip medical care altogether than those in other states, according to new analysis from the Government Accountability Office and the National Center for Health Statistics.

Sen. Ron Wyden (D-Ore.) requested the analysis, conducted among adults ages 19-64 in states that have not yet expanded Medicaid under the Affordable Care Act. The analysis found about 20 percent of poor people in those states passed on medical care in the past year because they could not pay for it, compared with 9.4 percent of those in states where Medicaid had been expanded, the Associated Press’s Ricardo Alonso-Zaldivar reports.

The survey found 8 percent of low-income people skipped care like medicine doses in states that did not expand the program compared with 5 percent in other states. The report found 22 percent said they needed but could not pay for dental care, compared with 15 percent in expansion states. Eleven percent said they needed to see but could not afford a specialist, compared with 6 percent in expansion states.

“States around the country have an opportunity to expand Medicaid to more people; these findings help show why it's a winning proposition for states and the millions of Americans currently left out,” Wyden said, per the AP.

OUCH: An internal investigation by Harvard Medical School revealed that 31 scientific publications from a high-profile cardiologist included fraudulent data.

“Piero Anversa and his colleagues were credited with finding a population of cells in the heart that suggested the organ has the ability to regenerate,” our Post colleague Carolyn Y. Johnson reports. “His work, underwritten by millions of dollars in federal funding, helped lay the groundwork for clinical trials, and cardiologists continue to study ways to repair the heart with stem cells.”

But those cells may not work the way Anversa’s research suggested. “Following a review of research conducted in the former lab of Piero Anversa, we determined that 31 publications included falsified and/or fabricated data, and we have notified all relevant journals,” Harvard and Brigham said in a joint statement. Anversa, who left the Harvard-affiliated Brigham and Women’s Hospital in 2015 “under the shadow of the ongoing internal investigation over the integrity of the work performed in his lab,” as Carolyn writes, had published more than 100 scientific papers.

“Several journals said they had recently received communications from Harvard detailing problems with studies from Anversa’s lab and were considering their policies before deciding whether to retract the articles,” Carolyn adds.

AGENCY ALERT

—  CMS announced that Mary Mayhew would run Medicaid nationwide. Mayhew previously worked as Maine health commissioner under Republican Gov. Paul R. LePage, who has refused to implement Medicaid expansion after voters overwhelmingly voted to approve a ballot initiative on the issue last November.

Mayhew now serves at the deputy administrator and director of Medicaid and the Children’s Health Insurance Program. Mayhew served as the health commissioner under LePage for six years and like the current Maine governor, was a vocal opponent of expanding Medicaid, according to the Portland Press Herald. Mayhew also finished third out of four Republican candidates in the June primary who ran to succeed the term-limited LePage. 

HEALTH ON THE HILL

— Rep. Lou Barletta, the Pennsylvania Republican running for Senate, pushed back on criticism from his opponent in an emotional video posted Sunday.

A new ad from Democratic Sen. Bob Casey targets Barletta for his vote to repeal the ACA, accusing him of wanting to take away health care from his constituents. The ad is narrated by someone whose twin daughters have cancer.

“Thank God we had health insurance,” the person in the ad says. “But if Lou Barletta has his way, kids like mine could be denied the care they need.”

In his Sunday post, Barletta said the ad came out after he had personally told Casey about his 18-month-old twin grandson who is receiving chemotherapy for cancer.

“Robert P. Casey Jr. knew that my grandson … who is a twin has cancer. I told him and his wife a month ago. They knew what we were going through,” Barletta says. “To run a commercial showing twins with cancer and to say that I would deny my own grandson health care might be the lowest thing I’ve ever experienced in my political life . . . He should take that commercial down and he should be ashamed of himself.”

Casey later announced he would pull the ad from Barletta’s home market. “Casey said in a statement Monday the parallels were unintentional and he takes Barletta at his word about the impact it had on his family,” the Associated Press reports.

STATE SCAN

— Battling a tough reelection bid, Wisconsin's Republican Gov. Scott Walker is delaying the implementation of Medicaid work requirements in his state out of concern about the political consequences, Politico’s Dan Diamond reports.

One official told Dan the Trump administration has been ready to approve and announce work rules in the state but “Wisconsin’s been stalling.” But Julie Lund, a spokesperson for Wisconsin's Department of Health Services said there's no delay, saying there are “ongoing conversations.” “We’ve felt it’s close for a while,” Lund said.

“Walker's hesitation to impose the strict Medicaid work rules comes as many Republicans have retreated from health care on the campaign trail — and as Democrats hammer the message the GOP is working to strip health protections from millions of people,” Dan writes. “The calculus is that focusing voters’ attentions on health care in a year when Republicans are playing defense on the issue is likely to hurt Walker with independent voters who are expected to decide the election. The two-term governor is effectively tied with or trailing Democratic candidate Tony Evers in multiple polls ahead of the Nov. 6 election.”

— After another month of Medicaid work requirements in Arkansas, more than 4,100 more people will lose their coverage for failing to meet the state’s standards, the state announced yesterday. That’s in addition to the more than 4,300 people who were cut from Medicaid rolls in September.

“In all, 76,200 Arkansans ages 30 to 49 were subject to the requirement and must spend 80 hours per month working, volunteering, going to school or receiving job training,” ModernHealthcare’s Harris Meyer reports. “Most either met the requirement or qualified for exemptions. Next year, individuals ages 19 to 29 will be subject to the mandate.

“In total, 15,276 adults were terminated this month from the state's Medicaid expansion program due to factors including noncompliance with the work or reporting rules, inability to contact the person or increased household income. Non-compliance and failure to return requested information accounted for more than half the terminations.”

— A child in Florida has become the first death of this flu season, the Florida Department of Health’s Bureau of Epidemiology announced.

The child died sometime the week of September 30, the Miami Herald’s Madeleine Marr reports. The department noted that the child was unvaccinated and was otherwise healthy before getting the flu. 

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

Throughout Supreme Court Justice Brett Kavanaugh's brutal confirmation fight, protesters targeted Collins in intensely personal fashion.
Politico
REPRODUCTIVE WARS
In Madagascar and dozens of other countries, health providers are facing cutbacks after a dramatic change to foreign aid by the Trump administration.
Max Bearak and Carol Morello
Health & Science
How five moms created a nonprofit that helps pregnant women and medical profession avoid fetal deaths.
Michael Ollove
MEDICAL MISSIVES
Dozens of people were unaccounted for and some 190,000 electric customers lacked power in the wake of Hurricane Michael.
Wall Street Journal
One out of every 10 students lived in temporary housing during the last school year.
The New York Times
INDUSTRY RX
Fifteen murder and sexual assault cases have been solved since April with a single genealogy website. This is how GEDmatch went from a casual side project to a revolutionary tool.
The New York Times
Bayer's chief executive is considering farming out certain drug research ac...
Reuters
Efforts to control health care costs have failed.
Axios
DAYBOOK

Coming Up

  • The FDA hosts a joint meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Wednesday.
  • The FDA hosts a meeting of the Gastrointestinal Drugs Advisory Committee on Thursday.
  • Politico hosts an event on “Using Tech and Innovation to combat opioid abuse and diabetes” on Thursday.
  • Brookings Institution holds a conversation with CMS administrator Seema Verma on Thursday.
SUGAR RUSH
Trump on Warren: ‘I hope she's running for president’