THE PROGNOSIS

Lowering the price of prescription drugs is a popular talking point for both sides of the aisle, and a mantra for President Trump.

The Senate last night took a step in that direction by voting to eliminate "gag clauses" that pharmacists say prevent them from disclosing when there's a cheaper way to buy prescription drugs. The move allows lawmakers to claim a significant win when they go before voters in the November elections, but it's less clear how much it would move the needle in the complicated effort to lower drug prices.

Hours before the Senate vote, the issue received a major boost when President Trump tweeted about it, criticizing "gag clauses" and calling on senators to support banning them:

The Senate passed on a vote of 98 to 2 the Patients Right to Know Drug Prices Act, a bipartisan bill Sen. Susan Collins (R-Maine) introduced in March along with Sens. Claire McCaskill (D-Mo.) and Debbie Stabenow (D-Mich.) that will block insurers or PBMs from prohibiting pharmacies from informing customers of any difference between their insurance co-pay and the cash price a prescription drug. The legislation also says that pharmacies cannot be penalized if they do share that information with customers.

Sens. Mike Lee (R-Utah) and Rand Paul (R-Ky.) opposed the effort.

Prior to the final vote, the upper chamber defeated, 11 to 89, an amendment, sponsored by Lee, that would have only applied the gag rule ban to some plans that are regulated at the federal level. 

Lee's amendment would have had states take the lead on banning gag clauses. As of last month, at least 25 states had enacted their own laws addressing gag provisions, according to the National Conference of State Legislatures.

"Some have suggested that this state action and increased attention to the cost of prescription drugs has more or less solved this problem and greatly limited the use of gag clauses already," Lee said in a news release about his amendment.

"However, even if gag clauses are still in use, we must recognize that it is not the role of the federal government to regulate entities under the jurisdiction of the states. However well-intentioned, when Congress oversteps its authority like this, we usually end up doing more harm than good."

It's unclear how much of a difference the move will make in lowering drug prices, anyway.

Some industry experts say lifting gag clauses is just a small step to getting Americans lower prices for their medicine because, while it increases transparency, it doesn't address the underlying issue of actual drug costs. 

“This is an important but incremental step,” said Lauren Blair,  spokeswoman for the Campaign for Sustainable Rx Pricing. “This is certainly progress but there’s a lot more work to be done, both in the transparency bucket specifically, and broadly in the larger effort to tackle drug prices. And again, transparency is not enough to tackle outrageous drug prices.”

Blair added transparency should be paired with additional efforts to address prescription prices, such as allowing for opportunities to increase competition in the drug marketplace to create more affordable options.

Gag clauses are provisions buried in the fine print of contracts that pharmacy benefit managers (​​PBMs) have with pharmacists. The provisions prevent many pharmacists from telling customers when the cash price for a medicine may be less expensive than their insurance co-pay unless the customers directly ask.

A similar measure to ban the practice passed the House Energy and Commerce Committee last week.

In a statement to The Health 202, bill sponsor Rep. Earl L. “Buddy” Carter (R-Ga.) applauded the passage of the Senate's version and urged a full House vote soon on his bill. 

"As a pharmacist for more than 30 years, gag clauses prohibited me from telling my patients about a better option for them many times," he said. "I know how important it is for patients that we end this unfair practice and I am thankful my colleagues in the Senate realize the critical need as well."

Lifting the ban was part of the White House blueprint on lowering drug prices. In May, when announcing the plan, President Trump called PBMs “dishonest, double-dealing” middleman, and singled out gag rules, calling them a "total rip-off," and said he wanted to eliminate them.

If the legislation makes it to Trump's desk, it's just one narrow slice of a massive undertaking to lower the skyrocketing cost of prescription drugs. 

Lawmakers may hope passing the bill will give them bragging rights on the campaign trail. But most Americans are cynical about any real change emerging from  this or any other proposed policy changes. In a July poll from Politico-Harvard, 81 percent favored eliminating the gag clause clauses, but only 42 percent believed it would result in lower drug prices. 

Moreover, 57 percent didn't believe Trump's plan would make a difference in what their family pays for prescription drugs, while 22 percent thought they would spend less on their medicines and 13 percent believed they would spend more. 

Blair said the bill's passage is heartening because it shows Republicans and Democrats, as well as the White House, are "rallying behind the issue." 

"Not everybody will agree on every solution, but everyone is acknowledging there’s a problem," she said. "This is a prime example of the fact that people are getting on the same page on the solution... Bills like this make it clear, it doesn’t matter what side of the aisle you’re on, we need to advance solutions."

AHH, OOF and OUCH

AHH: Supreme Court nominee Brett M. Kavanaugh and Christine Blasey Ford, the woman who has accused him of sexually assaulting her in high school, will both testify before the Senate Judiciary Committee on Monday.

After Ford’s initial offer through her attorney to testify about her allegations, which yesterday sparked a number of calls from senators to postpone Kavanuagh's confirmation, Senate Republicans delayed a committee vote that had been planned for Thursday and “abandoned tentative plans for the matter to be handled behind closed doors,” The Post’s Felicia Sonmez, Seung Min Kim. Sean Sullivan and John Wagner reports.

The White House said in a statement that Kavanaugh “looks forward to a hearing where he can clear his name of this false allegation.” Kavanaugh yesterday again denied the allegations. “I have never done anything like what the accuser describes — to her or to anyone,” he said in a statement. “Because this never happened, I had no idea who was making this accusation until she identified herself yesterday.”

Sen. Collins, a critical swing-vote on the nomination, said if Kavanaugh has not been truthful about the alleged incident, it would be “disqualifying.”

“Obviously, if Judge Kavanaugh has lied about what happened, that would be disqualifying,” Collins said yesterday, adding that “having the opportunity to observe her being questioned, read a transcript and a deposition and make that kind of assessment is so important.”

The president came to Kavanaugh’s defense, saying he is “one of the finest people that anybody has known” and signaling that he supports a hearing on the allegations.” ““If it takes a little delay, it’ll take a little delay,” Trump told reporters. “It will, I’m sure, work out very well.”

Is Kavanaugh’s nomination in jeopardy? Our Post colleague Philip Bump writes the patterns following Ford’s decision to come forward were “so predictable that it seems hard, in the abstract, to evaluate the political ramifications of her coming forward. So it’s worth noting that, even before Ford told her story to The Washington Post, Kavanaugh’s nomination was historically weak.”

It’s the second time in less than a year Republicans are banking on someone accused of sexual assault to win an important government job. “But the stakes this time are much bigger than with [Roy] Moore,” our Post colleague Aaron Blake writes. “The political dynamics are ripe for getting it wrong, and the consequences would be extreme…. Republicans are arguing that the late nature of this disclosure, after Kavanaugh already went through confirmation hearings and just before he was to be approved by the Senate Judiciary Committee, makes skepticism warranted. But the timing also makes their maneuvering much more difficult — and fraught. The GOP clearly wanted to confirm Kavanaugh before the 2018 election, both because it could rally the base in a tough midterm year and because there is always the chance that Democrats could win the Senate.”

OOF: Florence’s wind and rains have passed through the Carolinas, but the worst could be yet to come as health dangers emerge in the storm's aftermath. Such hazards can range from hazards surrounding sharp objects that have been submerged in the floodwaters, bacterial infections and disease-carrying mosquitoes, our Post colleagues William Wan, Lena H. Sun and Carolyn Y. Johnson report.

“People are trapped by floodwaters and facing dwindling supplies of medicines, food and drinking water,” they write. “Carbon monoxide poisoning is a danger as people crank up portable generators, and respiratory viruses will circulate in crammed shelters.

There are numerous health hazards of top concern following such a disaster. Most people who die during or immediately after a storm usually die by drowning, they write. But another immediate issue is getting people needed medication and accessing treatment for people with chronic illnesses.

There’s also a question of the mental toll on survivors. Our Post colleagues spoke with clinical psychologist Jean Rhodes who studied the aftermath of Hurricane Katrina. “Many were traumatized multiple times — by the violence of the storm itself, loss of family, loss of home, having to rebuild their lives in a new city, loss of relationships they built up in their neighborhood over years,” they write.

OUCH: A new report from the Health and Human Service’s inspector general found about a third of foster children from a sample of states were prescribed powerful psychiatric drugs without safeguards such as treatment plans or follow-ups, the Associated Press’s Ricardo Alonso-Zaldivar reports.

The report, based on a sample of 125 cases from five states with the highest rate of foster children treated with such drugs, found “34 percent of children did not have either treatment plans or follow-up monitoring translates to about 4,500 children in the five states examined,” Ricardo reports.

“Kids getting mood-altering drugs they don’t need is only part of the problem,” he adds. “Investigators also said children who need medication to help them function at school or get along in social settings may be going untreated. The drugs include medications for attention deficit disorder, anxiety, PTSD, depression, bipolar disorder and schizophrenia. Foster kids are much more likely to get psychiatric drugs than children overall.”

The inspector general’s report is recommending that the Administration for Children and Families establish a plan to help states meet standards for prescribing psychiatric drugs to foster kids.

HEALTH ON THE HILL

—The Senate passed 99-1 Monday night a sweeping package of 70 bills to address the nation's opioid crisis. The legislation creates, expands, and reauthorizes programs across many agencies aimed at hitting the epidemic from all sides. 

Lawmakers and advocacy groups hailed the passage as a signal of Washington finally taking seriously an issue that killed nearly 50,000 people last year. But many public health advocates and experts say the narrowly-focused proposals will do little to actually change anything significantly without a large, long-term funding commitment from the federal government. 

The bill, among many other things, closes a loophole that allows the synthetic opioid, fentanyl, to flow freely through the U.S. Post Office, creates a grant program to establish more recovery centers, expands doctors and nurses access to medication-assisted-treatments, and allows the Food and Drug Administration to require drug companies to package their opioids in three to seven-day supplies. 

Lee was the lone dissenter. 

— Rep. Chris Collins's attorney said the New York Republican will stay on the ballot in November following his federal indictment for insider trading and lying to investigators, our Post colleague Mike DeBonis reports, a reversal of his initial decision to suspend his campaign. Federal prosecutors in August charged Collins, alleging he schemed with his son to avoid losses on an investment in biotechnology company Innate Immunotherapeutics.

“That is a scenario that Republican Party officials had hoped to avoid,” Mike writes. “While New York’s 27th Congressional District is heavily Republican, Democrats believe that with Collins on the ballot, they have an outside chance of claiming the seat in November as they fight to retake the House majority.”

“For weeks, state Republican officials explored finding a way for Collins to vacate the general election ballot and replace him with an untainted GOP candidate, but under New York state law there are scant options for a primary winner to spurn his party’s nomination,” Mike adds. “Short of death or moving out of state, Collins would have had to accept the Republican nomination for another state office.”

AGENCY ALERT

— The National Institute on Alcohol Abuse and Alcoholism has changed information on its website following criticism from a public health expert who said language on the site was not worded strongly enough about the risks of cancer associated with drinking. The website now says there is “a strong scientific consensus of an association between alcohol drinking and several types of cancer,” and notes HHS lists alcohol as a known human carcinogen.

The website previously said “Drinking too much alcohol can increase your risk of developing certain cancers.”

“Public health and alcoholism researcher Dr. Michael Siegel, of Boston University, last week called on the National Institutes of Health, of which NIAAA and NCI are a part, to retract and apologize for the language,” Stat’s Sharon Begley reports. “He charged that the wording misled people into thinking that only drinking to the point of impairment posed a cancer risk.”

“We appreciate Dr. Siegel pointing out an area that needed attention and have updated the information on this page accordingly,” a spokesman from NIAAA spokesman told Stat. “We are continuing our review of the full website. NIAAA’s goal with the website is to present the most accurate version of the existing data.”

INDUSTRY RX

—  Federal officials yesterday gave health insurer Cigna the green light on its $52 billion acquisition of pharmacy benefit manager Express Scripts, the two companies said in an announcement.

“The combination represents a major reshuffling of the health care industry as companies try to constrain costs and gird for the long-expected entrance of Amazon into the sector,” Politico’s Paul Demko reports. “The looming approval of the deals comes two years after Obama administration regulators blocked a major proposed consolidation in the health insurance industry over concerns about diminished competition. DOJ successfully sued in 2016 to halt Anthem’s proposed acquisition of Cigna and Aetna’s merger with Humana.”

“By contrast, the Cigna-Express Scripts deal was expected to be approved with few strings attached,” Paul adds. “The companies had combined revenues of nearly $150 billion last year. Express Scripts was the last major standalone pharmacy benefit manager… The Justice Department concluded that the merger wouldn’t harm competition in either the insurance or PBM markets. The agency’s antitrust division said it reviewed more than 2 million documents and interviewed more than 100 industry sources in reaching that conclusion." 

“We are pleased that the Department of Justice has cleared our transaction and that we are another step closer to completing our merger and delivering greater affordability, choice and predictability to our customers and clients as a combined company,” Cigna president and CEO David Cordani said in a statement. 

The deal is expected to close by the end of the year.

— Here are a few more good reads: 

National
Crowded shelters and English-only storm warnings left some exposed to the hurricane’s wrath.
Rachel Siegel, Katie Zezima and Kristine Phillips
Despite improved safety standards over the years, more than 230,000 children under 15 months old were treated in hospital emergency rooms for injuries related to infant walkers from 1990 through 2014.
NPR
A new AAP policy contains guidelines around the language, treatment options, and care to be used with patients whose gender identity doesn't match the one they were assigned at birth.
BuzzFeed News
Health & Science
He wonders: Will they will remember my name, or look me up, or resent me for years to come?
Nathaniel Morris
Speaking of Science
A psychologist's first reaction to his own study was: "This is nonsense." But the data convinced him.
Ben Guarino
The ACA's embattled requirement to cover contraceptives ought to include a smartphone app that’s FDA-cleared to prevent pregnancy, experts say. But how?
STAT News
Drug-pricing advocates are launching a six-figure ad campaign to try to stop Congress from rolling back a move targeting drug companies.
The Hill
DAYBOOK

Today

  • The Senate Health, Education, Labor and Pensions holds a hearing on reducing health care costs.

Coming Up

  • The Biden Cancer Summit begins on Thursday.
  • The FDA holds a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting announcement on Thursday.
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