THE PROGNOSIS

Congress could send its sweeping opioids' package to President Trump by week's end after lawmakers reached an agreement late Tuesday night on a final bill to address the nation's public health crisis. 

Several issues held up negotiations, but the biggest controversy had nothing to do with opioids at all. 

News broke last week that the pharmaceutical industry was pushing for lawmakers to insert language into the popular opioids' package that would ease how much it owed in covering some Medicare drug costs. But a concerted effort by patient-advocate groups successfully blocked the last-minute add that would have given drug companies a $4 billion windfall. 

Groups like the AARP,  the American Hospital Association and the Campaign for Sustainable Rx Pricing blasted the move, decrying the drug industry for trying to insert its own interests into the process as lawmakers from both chambers hammered out differences in the House and Senate-passed bills. Even as late as Tuesday evening -- when it seemed unlikely, yet still remained unclear whether the drug industry change would make it in -- the groups sent a letter to congressional leadership reiterating their position. 

"Tying a bailout for the pharmaceutical industry to any legislative efforts will come at the expense of patients and taxpayers and send the exact opposite message – especially if the purpose of the vehicle is to help Americans fight opioid addiction, an epidemic that the drug companies themselves helped create in the first place," the groups wrote. 

PhRMA, a powerful industry lobbying arm, pushed hard in the last few days to reverse a provision in the bipartisan budget law passed in February requiring drug manufacturers to give Medicare patients deeper discounts on their prescription drugs to address the so-called Medicare Part D "doughnut hole,"  or coverage shortfall that ends up forcing seniors to pay more for prescription medications. The budget bill aimed to close the gap so that seniors would only pay 25 percent of the cost of brand-name drugs if they reached their plan limits.

As part of its lobbying effort, PhRMA offered to accept a version of the CREATES Act, which has been approved by the Senate Judiciary Committee. That legislation would stop manufacturers of brand-drugs from blocking generic drug developers from bringing their versions to market. 

But a Democratic source familiar with the negotiations told The Health 202 that the CREATES Act was not part of the discussions around the opioids' bill, so lawmakers did not agree to add the PhRMA change. 

In a joint statement, House and Senate lawmakers who negotiated the deal said, "Once signed into law, this legislation sends help to our communities fighting on the front lines of the crisis and to the millions of families affected by opioid use disorder. While there is more work to be done, this bipartisan legislation takes an important step forward and will save lives.”

Other groups won similar victories. As I wrote last week, the House version of the opioid bill contained a provision that would have given the attorney general sweeping power to schedule and set penalties for the synthetic and deadly drug fentanyl and other drug compounds. Criminal justice reform advocates fought against it, calling attempts to include such language a reboot of the "war on drugs." The provision did not make it into the final version. 

Another win for public-health advocates was the removal of the IMD exclusion, a 1965 rule that prohibits federal Medicaid reimbursements for inpatient treatment centers with more than 16 beds whose patients are mainly suffering from mental illness. A version of the exclusion was in the House-passed version, but did not make it into the Senate bill. But a bipartisan push by Sen. Rob Portman (R-Ohio) resulted in its inclusion in the final package.

Last week, Portman partnered with three Democratic senators, Dick Durbin (Ill.), Ben Cardin (Md.) and Sherrod Brown (Ohio), to introduce a bill that lifts the IMD cap for patients with any substance abuse disorders (early versions in the House bill only covered opioid addiction). In practice that means that those with substance abuse disorders will receive Medicaid coverage for their treatment at larger treatment centers.

“Lifting the IMD exclusion is one of the most important things we can to do expand access to treatment right now for those who truly need it,” Portman said in a statement last week.  “I’m pleased that the House and Senate are taking action to combat this opioid epidemic, but we should not let this opportunity pass us by without finally resolving this IMD issue once and for all."

The overall final package to be signed into law is a 660-page document that chips away at the opioid addiction crisis by expanding and creating programs across the federal government that address prevention, treatment and recovery.

Supporters of the bill laud its passage as a rare bipartisan victory on a critical issue that's killing tens of thousands of Americans each year. But critics say it's too little, too late and that without a massive infusion of new federal dollars aimed at treatment, particularly around medically assisted treatments, the crisis will continue. 

Regardless of the disagreement over the bill's effectiveness, it's really come down to a question of optics. The fact that Congress rushed to finish this work before the midterms shows how eager lawmakers on both sides are to be able to go home with this victory in their back pockets.

AHH, OOF and OUCH

— Republican senators selected Arizona prosecutor Rachel Mitchell to question Supreme Court nominee Brett K. Kavanaugh and Christine Blasey Ford in testimony before the Senate Judiciary Committee Thursday about her claims of sexual assault by Kavanaugh, our colleagues Sean, Josh Dawsey, Rosalind S. Helderman and Michelle Ye Hee Lee report.

“In enlisting Mitchell to join their staff, Republican senators are taking an unusual step,” they write. “They are turning to her to ask what are expected to be personal and potentially painful questions about the woman’s youth on live television, sparing the all-male panel of 11 Republican senators on the committee some uncomfortable exchanges that could sway the public’s opinion about the session.”

Meanwhile, Sen. Lisa Murkowski (R-Alaska), a critical swing vote on the Kavanaugh nomination, warned her fellow senators to hear Ford out.

“We are now in a place where it’s not about whether or not Judge Kavanaugh is qualified,” she said, reports the New York Times’s Peter Baker and Nicholas Fandos. “It is about whether or not a woman who has been a victim at some point in her life is to be believed.”

President Trump on Tuesday offered his most full-throated attack on the women who have accused Kavanaugh of sexual misconduct.

For its part, the Senate Judiciary Committee scheduled a Friday morning vote on Kavanaugh’s nomination, Politico’s Elana Schor, John Bresnahan and Burgess Everett report. “According to committee rules, Judiciary must schedule a committee vote three days in advance. But the committee said the vote will proceed only if a ‘majority of the members’ of the 21-member panel are ready to vote on Friday,” they write.

Trump meanwhile offered a new dismissal of the account of Deborah Ramirez, a classmate of Kavanaugh’s at Yale University, who told the New Yorker magazine that Kavanaugh exposed himself to her at a party. The president said that Ramirez “has nothing” because she was “totally inebriated and all messed up.”

“The second accuser has nothing,” Trump told reporters. “The second accuser thinks maybe it could have been him, maybe not. She admits she was drunk. She admits time lapses.” The president blamed the emergence of the accusations on Democrats, as our Post colleagues John Wagner and Sean Sullivan and Seung Min Kim report.

“I think it is horrible what the Democrats have done,” he said. “It is a con game, they are really con artists.” Read an annotation of the president’s comments on Kavanaugh’s accusers from our Post colleague Aaron Blake here.

 

OOF: Former U.N. secretary general Ban Ki-moon pointed fingers at corporate interests in the United States for preventing the government from establishing a universal health-care system that would provide insurance for millions more Americans.

He called the U.S. government’s failure to provide health coverage “unethical” and “politically wrong, morally wrong,” in an interview with The Guardian’s Jessica Glenza and said interests such as pharmaceutical companies, hospitals and doctors are preventing the government from providing such coverage.

“It’s not easy to understand why such a country like the United States, the most resourceful and richest country in the world, does not introduce universal health coverage,” he said. “Nobody would understand why almost 30 million people are not covered by insurance… Leaders are elected because they vowed that they would work for the people. They are abandoning people because they are poor, then these poor people cannot find a proper medical support.”

Last year, 28.5 million people did not have health insurance, our Post colleague Jeff Stein reports. This month, U.S. Census Bureau figures showed that for the first time this decade, the United States made no progress in reducing the rates of people without health insurance.

“While swearing in as secretary general, I pledged I would make this world better for all,” Ban told The Guardian. “Nobody would imagine that there should be so many people – 30 million people – who would be left behind” in the United States.

OUCH: The head of emergency operations for the World Health Organization warned of a “perfect storm” that could lead to a spread of Congo's latest Ebola outbreak, including public hesitation around vaccinations as well as political fear-mongering related to the threats posed by rebel groups in the region, the Associated Press reports.

“Dr. Peter Salama said the response to the deadly hemorrhagic fever is at a ‘critical juncture’ in eastern North Kivu province, where the outbreak was declared nearly two months ago,” per the report.

There have been 119 confirmed cases, including 69 deaths, since the outbreak began, and officials are worried that Ebola could spread internationally, particularly to Uganda, per the report.

"Overall trends in the Ebola response have been positive, Salama said. But the deadly threat posed by rebel groups, public fears about treatment options in a region facing its first Ebola outbreak and politicians fanning those fears ahead of elections in December have presented challenges," per the AP, adding Salama said those factors "may be coming together over the next weeks to months to create a potential perfect storm."

AGENCY ALERT

— The Trump administration says it will review all federally funded research that includes the use of fetal tissue and canceled one such contract, “stepping into a decades-old controversy that has been a sidelight to the ideological war over abortion,” our Post colleagues Amy Goldstein, Ariana Eunjung Cha and Laurie McGinley report.

After first announcing this week it had canceled a relatively small contract with California-based nonprofit group Advanced Bioscience Resources, the Department of Health and Human Services followed with an announcement about its wider audit of “all acquisitions involving human fetal tissue,” adding its research review came up “in light of serious regulatory, moral and ethical considerations involved.”

An HHS spokeswoman would not tell The Post how many government contracts or projects will be under review, or how long the inquiry will take.

“Both supporters of such research and its opponents said they were uncertain whether HHS’s unprecedented review was intended largely as a bold symbolic step to appease the administration’s conservative allies or is a precursor to abolishing federal funding of fetal tissue, which has been employed in studies since the 1930s,” our colleagues report. They add the department is working with House Republicans, “the most recent in a series of moves by the department since President Trump took office that align with the longtime agenda of social conservatives.”

House Speaker Paul D. Ryan (D-Wis.) worked with Azar to address the ABR contract, a Ryan spokeswoman told our colleagues. Weeks prior, leaders of nearly four dozen antiabortion and faith-based groups had sent a letter to Azar with complaints about it. 

—Food and Drug Administration commissioner Scott Gottlieb said an outright ban online e-cigarette sales is “on the table” and something the agency is “very clearly looking at.”

Gottlieb made the remarks at an event hosted by Axios, according to CNBC's Angelica LaVito.

His remarks follow the agency’s suggestion earlier this month that it was considering banning flavored e-cigarettes and an announcement about a crackdown on retailers of the product. 

Gottlieb said the FDA plans to release information about teen vaping, as well as its next moves on e-cigarettes in November.  

INDUSTRY RX

— A new study has found health-care plans make up the greatest amount of patient records stolen over the last seven years, Reuters’s Linda Carroll reports.

The new analysis, published in JAMA, found there were 2,149 breaches that involved a total of 176.4 million patient records, Linda reports. Across the seven years included in the study, the number of breaches increased every year except for 2015, with 199 in 2010 and 344 in 2017.

“The researchers found that 510 breaches involved paper and film records, which impacted about 3.4 million patients, as compared to 410 breaches of network servers that impacted nearly 140 million records,” Linda writes. “The three largest breaches together accounted for more than half of the stolen records.”

Chris Carmody, senior vice president of infrastructure and services and president of ClinicalConnect Health Information Exchange at the University of Pittsburgh Medical Center in Pennsylvania explained that it’s the financial data in the health records that appeal to the hackers. “With that information someone could go out and get a credit card account,” Carmody told Linda. “Or a criminal could go out and sell it on the dark web, the shady part of the internet where identities are sold and traded.”

— Drug giant Novartis announced it will eliminate more than 2,000 jobs as part of its planned revamp to focus on producing high-value drugs, the Wall Street Journal’s Donato Paolo Mancini reports.

The Swiss pharmaceutical giant will cut 1,000 production jobs, 700 business services positions and 400 jobs at a plant in the U.K.

“The cuts are part of Chief Executive Vasant Narasimhan’s plan to make the company more focused on ‘personalized and specified’ medicines, including gene therapies that can costs hundreds of thousands of dollars per patient, rather than on high-volume drugs,” Donato writes. “Tuesday’s announcement underscores changes throughout the Swiss pharmaceutical industry, a key source of jobs and exports. The Wall Street Journal reported in July that Roche Holding AG , another Swiss drug giant, would shut regional offices as part of a restructuring.”

REPRODUCTIVE WARS

—Antiabortion advocates are working to mobilize voters around the issue in the runup to the midterm elections, Politico's James Arkin reports. 

The issue always plays prominently in election-year politics, but has even more resonance with a vacant Supreme Court seat opening the door for the overturning of Roe v. Wade

James writes that leading antiabortion group, Susan B. Anthony List, has canvassers knocking on doors in Ohio, Florida, Missouri, Indiana, West Virginia and North Dakota, hoping to energize a Republican base in places where races are tight, particularly those where President Trump won but Democrats hold seats. 

James points to these examples of the antiabortion push:

"Earlier this week, the Tennessee Republican Party posted video of former Gov. Phil Bredesen expressing support for Planned Parenthood, and criticized him as out of touch with the state. Last month, Susan B. Anthony List and the NRSC both aired TV ads attacking Sen. Joe Manchin of West Virginia over a vote against defunding Planned Parenthood," James writes. "In North Dakota, the NRSC also ran digital ads attacking Sen. Heidi Heitkamp for appearing to high-five Minority Leader Chuck Schumer after a vote against a 20-week abortion ban (Politifact ruled the attack false). They also ran a TV ad criticizing Heitkamp for the vote in August."

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

Wonkblog
Yes, John Hancock and other life insurance companies are primarily interested in saving money. But research shows you could benefit too.
Christopher Ingraham
Here’s how to fix America’s painkiller problem — without leaving pain patients behind.
Vox
Business
If you express interest in buying drugs illicitly, expect a flood of solicitations to be funneled to you.
Elizabeth Dwoskin
D.C. Politics
Drugs sold in stores as cheap alternatives to pot have been linked to 1,600 suspected overdoses.
Fenit Nirappil
No matter who wins Utah’s U.S. Senate race in November, the Beehive State will have an advocate in Washington, D.C., for moving marijuana off the list of Schedule 1 controlled substances, a designation that cannabis now shares with heroin, LSD and ecstasy.
Salt Lake Tribune
The Fix
She's right -- Trump has no trouble believing victims when the person accused is a political rival.
Eugene Scott
The Fix
Someone can abstain from sexual intercourse yet still commit a sexual assault.
Eugene Scott
Shingrix, the vaccine approved last year to prevent shingles, has proved so popular that its maker, GlaxoSmithKline, has not been able to produce it quickly enough.
The New York Times
Morning Mix
Now called WW, the company also sports a new tagline: “Wellness that Works.”
Allyson Chiu
DAYBOOK

Coming Up

  • The Senate HELP Committee hosts a hearing on reducing health -costs Thursday.
  • The House Energy and Commerce Subcommittee on Health hosts a hearing on reducing maternal mortality in the U.S. Thursday
  • Sen. Rob Portman (R-Ohio) speaks at the American Enterprise Institute to discuss combating the international shipment of opioids Thursday.
SUGAR RUSH

Sen. Kamala Harris (D-Calif.) says public 'deserves to know' who Kavanaugh is:

Sen. Mitch McConnell (R-Ky.) said he was “confident” Kavanaugh would be confirmed to the Supreme Court:

Bill Cosby leaves court in handcuffs after being sentenced to prison: