THE PROGNOSIS

House Speaker Nancy Pelosi (D-Calif.) is poised to unveil drug pricing legislation – as soon as this week – as Congress and the White House strive this fall for a bipartisan deal to lower the steep cost of prescription medications in the United States.

The proposal will represent a wish list of new powers Democrats want to give the federal government, including allowing it to directly negotiate with prescription drugmakers for certain high-cost drugs, according to several lobbyists and aides. But Pelosi is hoping President Trump — who has bucked GOP orthodoxy by supporting such negotiations — might be eager enough for a win on drug pricing that he’ll meet her at least part of the way for a grand deal by year’s end.

It’s the autumn of truth for the White House and the Democratic-led House as time dwindles for them to agree on major legislation tackling the cost of health care. There’s no doubt both sides are acutely aware it’s a top voter concern heading into the 2020 election — and they want to be able to tell Americans they acted on it.

Trump’s administration is pursuing measures to crack down on drugmakers. The powerful Senate Finance Committee hauled in top pharmaceutical executives earlier this year to chastise them. Top congressional committees have composed a slate of bills aimed at lowering drug prices and easing the “surprise” medical bills patients get for care outside their plan’s network of doctors and hospitals.

But their success is far from certain. They’re up against the powerful pharmaceutical industry employing more lobbyists than ever. The parties are sharply divided over how much leverage the government should get. And negotiations could all devolve into political mudslinging if a lawsuit is upheld trying to dismantle Obamacare.

As Congress returns to Washington today from summer recess, the next four months are its window for a deal. Both parties feel that once January arrives, everyone will be be focused on the campaign and chances for bipartisan work will be slim.

Lawmakers are eyeing a few pathways for passing legislation to lower drug prices and attack surprise medical bills. Such measures could be tied to some must-pass bills extending funding for community health centers and other health programs at the end of September. It also could be passed on its own, giving Trump a prime opportunity to take some victory laps.

Or, in the most likely scenario, lawmakers would include a package dealing with drug costs — and perhaps surprise medical bills — at year’s end, as part of a “minibus” bill funding several government agencies.

“There are multiple paths forward and none of them are closed off yet,” a Senate GOP aide close to the discussions told me.

Here are the moving pieces to watch this fall:

1. There are a number of legislative packages from the Senate that could make it into a big, bipartisan package.

—The Senate Finance Committee passed a bipartisan bill from Chair Chuck Grassley (R-Iowa) and ranking Democrat Ron Wyden (Ore.) at the end of July that would reduce out-of-pocket costs and limit drug-price increases in Medicare. Its most controversial provision would require rebates from drugmakers that hike prices faster than inflation.

—In June, the Health, Education, Labor and Pensions Committee passed another bipartisan measure from its chairman, Lamar Alexander (R-Tenn.), and ranking Democrat Patty Murray (Wash.) to end surprise medical billing.

In a meeting at the end of July, all four committee leaders met and agreed they’d work to advance both measures simultaneously, along with Senate Judiciary Committee legislation aiming to rein in extensive patenting by drugmakers to block cheaper competitors.

2. There’s a lot to choose from on the House side, too.

—The House Energy and Commerce Committee has also passed a bipartisan surprise billing package, which takes a somewhat different approach compared with the HELP bill.

—Energy and Commerce staff are in talks with staff on the House Ways and Means Committee about options for a bipartisan bill on drug pricing. The bill probably will include a cap on out-of-pocket costs for Medicare enrollees once they spend enough to hit the “catastrophic” phase of coverage, similar to the Senate Finance bill.

—Several Democrats including Reps. Lloyd Doggett (D-Tex.) and Ro Khanna (D-Calif.) have introduced measures allowing the Department of Health and Human Services to directly negotiate lower drug prices in Medicare. Those measures can't pass the Senate, but they represent what progressives would like.

3. President Trump also wants his own health-care “plan.”

Officials at the White House and HHS are putting pressure on Congress to get drug-pricing legislation done. The president wants that badly. But there’s also chatter about some kind of plan — which could take the form of a white paper, or just a speech — that Trump could characterize as fulfilling his promise earlier this year for an Obamacare replacement.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services, told reporters last month that her agency is “actively engaged in conversations and working on things” when it comes to the plan Trump promised.

But she also couched her comments, saying CMS is advancing a health-care agenda with its work on improving care quality, lowering drug prices and increasing price transparency.

“I mean, to some degree you’re already seeing a plan in action, right?” Verma said. “Every day we’re implementing the president’s agenda on health care.”

4. The lawsuit seeking to strike down the Affordable Care Act could throw a wrench into all of this.

The U.S. Court of Appeals for the Fifth Circuit is expected to rule in the next few weeks on whether the 2010 health-care law is constitutional now that its penalty for being uninsured is off the books (that’s the basis for which the Supreme Court found the ACA constitutional back in 2012). The lawsuit was brought by GOP-led states and is backed by the administration.

Democrats spent the 2018 election cycle hammering Republicans over trying to get rid of the ACA and its protections for patients with preexisting conditions. If the court upholds the challenge, Democrats might find it more advantageous to spend their time talking about that rather than working on drug costs.

AHH, OOF and OUCH

AHH: A Washington Post-ABC News poll out this morning finds Americans, regardless of their political party, overwhelmingly support expanding background checks for individuals who buy guns and for allowing law enforcement to temporarily take weapons away from individuals who may be troubled as part of "red flag" procedures.

“The Post-ABC poll finds 86 percent of Americans support implementing ‘red-flag’ provisions, which allow guns to be taken from people judged to be a danger to themselves or others,” our Post colleagues Mike DeBonis and Emily Guskin report. “And 89 percent support expanding federal background checks to cover private sales and gun-show transactions. Both measures are supported by at least 8 in 10 Republicans, white evangelical Christians, members of gun-owning households and other traditionally conservative groups.”

The poll also found more than 70 percent of Americans in both parties say improving mental health monitoring and treatment could reduce mass shooting incidents, while there’s more division across party lines about whether stricter gun controls could reduce such shootings. As pressure increases on lawmakers to act on gun legislation, the poll found more Americans say they trust congressional Democrats over Trump to tackle gun laws.

OOF: Health officials said Friday that a fifth person died from a mysterious spate of vaping-related lung illnesses reported across the country. There are now 450 possible cases across 33 states and one territory, our Post colleague Lena H. Sun reports.

“Although federal and state officials said the definitive cause of the illness remains unknown, ‘the severity of the illness and the recent increase in the incidence of this clinical syndrome indicates that these cases represent a new or newly recognized and worrisome cluster of pulmonary disease related to vaping,’ according to a report by health department officials in Wisconsin and Illinois, who conducted a joint investigation of 53 patients,” Lena reports.

The Food and Drug Administration is investigating samples taken from ill patients. CDC officials believe a chemical exposure is likely. But federal officials stress no one substance — including the oil derived from vitamin E that officials found in samples of marijuana vaping products collected by sick people — has been found in all samples.

“Even though the definitive cause remains unknown, the mysterious lung illness is coming into focus as officials and clinicians identify clinical similarities in illnesses among people who vape. Preliminary reports released Friday from clinicians and state health departments in Wisconsin, Illinois, North Carolina and Utah confirm patterns that doctors treating patients have described,” Lena writes. “Most patients have been young and healthy. They had similar symptoms, including cough, chest pain or shortness of breath that appeared to take place over several days to several weeks before hospitalization, according to a CDC report released Friday." 

OUCH: Mallinckrodt Pharmaceuticals, a major generic opioid manufacturer, announced it has reached a settlement with two Ohio counties instead of going to trial in October over its role in the opioid epidemic, The Post’s Lenny Bernstein, Sari Horwitz and Scott Higham report.

Mallinckrodt would pay the counties $24 million in cash and donate $6 million in drugs such as addiction treatment medications under the settlement deal, and the company would be taken off the list of defendants facing the two counties. The proposed deal still needs to be approved by the county councils.

The Ohio trials brought by Cuyahoga and Summit counties in Ohio are “bellwether” cases testing whether the drug industry can be held responsible for the epidemic.

“Mallinckrodt is pleased we were able to reach a settlement in principle with the counties that made sense for all parties,” the company's general counsel Mark Casey said in a statement. He said resolving these test cases “gives us the necessary time to continue to work toward a global resolution of the opioid lawsuits.”

“The Washington Post reported in July that a Mallinckrodt subsidiary, SpecGX, was the single largest manufacturer of the more than 76 billion opioids distributed across the United States between 2006 and 2012,” our colleagues write. “Endo Pharmaceuticals and Allergan, which made smaller amounts of opioids that were distributed in Summit and Cuyahoga counties, already have settled with those counties.”

HEALTH ON THE HILL

— Sen. Kamala D. Harris (D-Calif.) apologized after she appeared to agree with a voter at a campaign event in New Hampshire who said Trump’s actions are “mentally retarded.”

“It was not something I really heard or processed,” she told CBS News. She called the term “incredibly offensive” and said in 2019 that one would think "people would have a much better understanding of how hurtful a term like that can be.”

During the Friday event, a voter asked a lengthy question about immigrants’ fears over Trump’s policies and finally asked:. “What are you going to do in the next one year to diminish the mentally retarded action of this guy?" Harris responded with a laugh and said: “Well said, well said.”

Harris told the voter she would use her power to support immigrants and that “ “unless you are Native American, or your ancestors were kidnapped and brought over on a slave ship, your people are immigrants. So let’s just be honest about that, and speak our values based on our shared lived values.”

After the video of the exchange circulated, Harris tweeted: “I didn't hear the words the man used in that moment..If I had I would’ve stopped and corrected him. I’m sorry.”

“Harris recently released a plan aimed to improve opportunities for disabled Americans, the first candidate in the sprawling Democratic field to do so,” our Post colleague Chelsea Janes reports. “In that plan, Harris promised to create new senior-level positions in the White House to focus on accessibility for people with disabilities, as well as requiring those receiving federal funding for transportation and housing projects to demonstrate that their plans are fully accessible.”

— Rep. Susan Wild, a freshman Democrat from Pennsylvania, is turning grief into action after her longtime partner took his own life earlier this year.

As she returns to Washington for the fall, Wild will begin advocating for mental health and suicide prevention resources, drafting mental- health legislation and organizing events, our Post colleague Rachael Bade reports. Wild, who did not at first speak publicly about her partner Kerry Acker’s death by suicide, opened up in a House floor speech in June.

“We still have such a stigma in this society, not only about suicide … but also about mental-health care,” Wild said. “I felt like if I use my public platform to talk about it, and also if I sort of took what I'm going to call the risk of talking about something so personal … it would make others feel like it was more accepted to talk about it and to acknowledge, whether it's them or their family member.”

“In the coming weeks and months, Wild envisions legislation making insurance companies cover mental health care the same way they would a physical ailment,” Rachael writes. “She’s already working with [the] Veterans Affairs secretary on veteran suicide prevention. And her office is also planning September events that will address supporting families through crisis.”

INDUSTRY RX

— Google said it would stop allowing advertisements for “unproven or experimental medical techniques,” which includes most stem cell therapy, cellular therapy and gene therapy after seeing an increase in “bad actors,” our Post colleagues William Wan and Laurie McGinley report.

“We know that important medical discoveries often start as unproven ideas — and we believe that monitored, regulated clinical trials are the most reliable way to test and prove important medical advances,” Google said in a post Friday about its new policy. “At the same time, we have seen a rise in bad actors attempting to take advantage of individuals by offering untested, deceptive treatments. Often times, these treatments can lead to dangerous health outcomes and we feel they have no place on our platforms.”

Industry experts say the new policy will up the pressure and scrutiny on stem cell clinics that have seen a recent boom, and as federal regulators have started to crack down on these clinics.

Some industry representatives are criticizing the move, suggesting it will punish “good” companies as it tries to deal with “bad actors,” our colleagues write. Andrew Ittleman, a Miami lawyer who represents several stem cell clinics, said Google had started refusing ads by some clinics in the past couple of years.

New research out this morning from UnitedHealth Group points to specialty prescription drugs, including medications needed to maintain chronic conditions, as one reason for increases in health-care costs. There has been a 14 percent annual increase in spending per capita on such drugs since 2013, according to the report.

The report says that instead of administering these medications in hospital outpatient settings, doing so in physician offices and in patients' homes can bring down the costs for patients by $16,000 to $37,000 per privately insured patient per year. Those estimates are based on UnitedHealth's costs for specialty drugs for five conditions: multiple sclerosis, immune deficiency, rheumatoid arthritis, inflammatory bowel disease and cancer that requires chemotherapy -- conditions that together make up 75 percent of spending on administered drugs.

— And here are a few more good reads: 

Two-thirds of Americans support legalization, but legislation seems to be going nowhere fast on Capitol Hill.
Politico
TRUMP TEMPERATURE
The 2020 presidential campaign has revealed a clear split on the future of mental health policy, with President Trump focused primarily on addressing gun violence and his potential Democratic foes making a wider variety of proposals.
Wall Street Journal
Senator Roy Blunt (R-Mo.) joins Meet The Press for an interview on the future of background checks and gun measures in Congress.
NBC News
The drug industry is working overtime to pull rank-and-file Republicans back into line.
Axios
AGENCY ALERT
National
Palynologists in a Chicago lab can help identify the origin of heroin, fentanyl and other drugs crossing the U.S. border.
Nick Miroff
MEDICAL MISSIVES
Health
Warnings about e-cigarettes have taken on new urgency in recent weeks as authorities scramble to understand a rash of mysterious vaping-linked illnesses that have put healthy people in the hospital with serious lung diseases.
Hannah Knowles
STATE SCAN
Maryland Politics
“Whatever they’re offering here, I’ll grab it,” one woman said. The volunteer clinic also provided vision care.
Peter Jamison
The layoffs are occurring at Ohio Valley Medical Center in Wheeling and sister facility East Ohio Regional hospital in Martins Ferry, Ohio. After two years of ownership, Irvine, California-based Alecto Healthcare Services announced both hospitals will close by next month.
Associated Press
OPIOID OPTICS
OxyContin maker Purdue Pharma and lawyers representing local governments both said Sunday that they’re interested in continuing negotiations to settle lawsuits over the toll of the opioid crisis a day after two state attorneys general told colleagues that their talks with the company were at an impasse and that they expected the company to file imminently for bankruptcy.
Associated Press
CLEVELAND (AP) — OxyContin maker Purdue Pharma is expected to file for bankruptcy after settlement talks over the nation’s deadly overdose crisis hit an impasse, attorneys general involved in the talks said Saturday.
Associated Press
REPRODUCTIVE WARS
Although abortion opponents say the laws are intended to reduce abortions and not send people to other states, at least 276,000 women terminated their pregnancies outside their home state between 2012 and 2017, according to an Associated Press analysis of data collected from state reports and the U.S. Centers for Disease Control and Prevention.
Associated Press
DAYBOOK

Coming Up

  • The House Energy and Commerce Subcommittee on Health holds a hearing on improving maternal health on Tuesday.
  • The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on holds a markup on Tuesday.
  • The Senate Joint Economic Committee holds a hearing on making it more affordable to raise a family on Tuesday.
  • The House Small Business Committee holds a hearing on barriers to care and burdens on small medical practice on Wednesday.
SUGAR RUSH

Congress is back in session. Here's what to expect this fall: