The Trump administration is poised to launch an improved version of databases showing how much the federal government spends on prescription drugs for seniors and low-income people as part of its recent tough talk on the U.S. drug industry.
For the first time, the drug spending dashboards published by the Centers for Medicare and Medicaid Services will display year-over-year changes in how much the agency spends on individual drugs for Medicare and Medicaid, according to details provided in advance to The Health 202.
The agency is also expanding both databases to include a majority of drugs prescribed under the dual federal insurance programs, instead of only drugs driving the most spending. The Obama administration launched the project in 2015 as a way of bringing more transparency to drug costs, but the new administration hadn’t updated the dashboards until now.
(For more details, tune in now to see me interview CMS head Seema Verma as part of our Washington Post Live series.)
The update is part of several transparency efforts being advanced by top Health and Human Services Department officials, who have spent recent days cheerleading the proposals to reduce drug spending rolled out by President Trump last week.
The plan, dubbed American Patients First, directs the Food and Drug Administration to start reviewing potential regulations to ensure drug manufacturers include the list price of medications in their advertising. In a speech yesterday, HHS Secretary Alex Azar drew attention to the idea, saying it’s “unfair” for patients to remain in the dark about whether a drug costs $100 or $50,000.
“Drug companies don’t have to wait on us,” Azar said. “Today, I am calling on America’s pharmaceutical manufacturers to level with the American public — be honest about what you’re trying to charge us; put your list price in your ads.”
And FDA Commissioner Scott Gottlieb told reporters to expect the launch of a new website on Thursday displaying letters the agency sends to brand-name drugmakers ingaimed at prevent competition by making it hard for generic drugmakers to obtain enough medicine samples necessary to create medicines.
Gottlieb has often called out brand-name companies for abusing a mandated safety program in order to keep large quantities of drugs out of the hands of their competitors. Posting FDA letters to these companies could “potentially serve as a deterrent to engaging in these practices,” Gottlieb said.
The drug pricing dashboards hadn’t been changed under the Trump administration, even though the Obama administration aimed to update them every year.
When Niall Brennan, CMS's former chief data officer, created and launched the initial dashboard, it included data on only 80 drugs under Medicare. To be included, the drugs had to fit into at least one of three categories: They cost a lot per person; they cost a lot overall; or their prices had grown exponentially over the past year.
Half the drugs displayed were provided under Medicare’s doctors' program known as “Part B,” while half were provided via Medicare’s “Part D” prescription drug program. The following year, CMS added a database including 70 of the highest-cost and highest-volume drugs paid for by state Medicaid programs
Since Trump's election, HHS has kept several important public data sets updated – including a massive database showing the prescription practices of Medicare doctors. But the drug spending dashboards have remained static. That led Democrats to complain the agency was dragging its feet. Last month, Rep. Frank Pallone Jr. (D-N.J.) sent Verma a letter asking why the dashboards hadn’t been updated and asking her to prioritize them.
“The failure to update the dashboards raises questions about this administration’s supposed commitment to lowering the price of prescription drugs for the American people,” Pallone, the top Democrat on the House Energy and Commerce Committee, wrote.
But it’s not surprising the administration would wait until this week to finalize the update, given all the public events, briefing and interviews Azar and Verma have been doing to draw attention to the push on drug prices. The changes aren't likely to excite the pharmaceutical industry, which objected when the dashboard was first launched.
Drugmakers said that the transparency tool presented a misleading and incomplete picture of actual Medicare spending by focusing on the most expensive drugs over the highest-volume drugs. They also argue that it doesn't reflect the hefty rebates by pharmaceutical manufacturers to insurers.
But, as Brennan noted to me, drugmakers could disclose the size of their rebates, which are partly blamed for prompting higher list prices. They just choose not to.
“They have an objection to anything that attempts to highlight or document high prescription drug prices, so I don’t think our effort was particularly egregious,” Brennan said.
There’s more work CMS could do around the databases to make them more user-friendly, however -- especially if the goal is to -expand its usefulness beyond health-policy wonks, industry insiders or journalists.
“I think you could definitely improve it if the focus is on the average person on the street using this as opposed to health policy specialists or journalists,” Brennan said. “I think there could be work done to make it more intuitive for consumers.”
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AHH: Meet John Zhang, the Chinese-born, British-educated founder and medical director of a Manhattan fertility center that is blowing up the way humans reproduce. Zhang was the first doctor to make possible a three-parent baby, by extracting a woman’s nuclear DNA, which carries the biological material responsible for such things as physical appearance and other major traits, inserting the DNA into a healthy donor egg and fertilizing it with sperm from the woman’s husband. The child, a boy born in 2016, appears to be healthy.
“For some, the 'three-parent baby' was a joyous miracle of 21st-century medicine,” The Post's Ariana Eunjung Cha writes. “For others — including U.S. regulators — the baby’s birth marked an unnerving step down the slippery slope of tinkering with human life in ways that are not fully understood.” It didn’t help that Zhang’s company soon began to market the technology through his two companies, New Hope Fertility Clinic and Darwin Life, which offered to take DNA from older women and put it into donor eggs from younger women so that women of almost any age could bear their genetic children.
“The proposed service landed him in the crosshairs of the Food and Drug Administration, which for decades has had a mostly hands-off policy when it comes to the fertility industry,” Ariana writes. “Last August, the FDA ordered Zhang to stop marketing the technology, effectively shutting down the program ... In a warning letter, FDA officials said Congress had effectively prohibited the genetic editing of heritable traits in human embryos in 2015 and that Zhang did not have approval to proceed with his research ... the FDA warned, 'such human subject research cannot legally be performed in the United States. Nor is exportation permitted.' "
OOF: Nineteen people have died of Ebola in the Democratic Republic of Congo and at least 39 people are suspected or confirmed to have the virus, the World Health Organization said yesterday. Another nearly 400 people who have been identified as contacts of Ebola patients were being assessed, our colleague Kristine Phillips reports.
“The global health agency announced last week its plans to send the vaccine, developed in 2016 by the pharmaceutical company Merck,” Kristine writes, adding officials hope it would be a “game-changer in preventing Ebola from spreading.”
OUCH: The number of U.S. workers who tested positive for cocaine and methamphetamine use skyrocketed last year, while fewer employees are using prescription opioids, The Post's Katie Zezima reports. According to an analysis of more than 10 million drug tests administered by Quest Diagnostics, 4.2 percent of workers who were screened for drug use last year tested positive. The rate remains unchanged since 2016, but it still remains significantly higher than in 2012, when 3.5 percent of employees tested positive for drugs.
“Not only have declines appeared to have bottomed out, but also in some drug classes and areas of the country, drug positivity rates are increasing,” said Barry Sample, senior director of science and technology at Quest Diagnostics.
"Positive testing for methamphetamine has skyrocketed in the South and Midwest in the past five years," Katie writes. "Between 2013 and 2017, positive drug tests for methamphetamine increased by 167 percent in the region that includes Illinois, Indiana, Michigan, Ohio and Wisconsin and 160 percent in Alabama, Kentucky, Mississippi and Tennessee...There also has been a surge in positive tests for cocaine. In Nebraska, there was a 91 percent increase in positive cocaine tests from 2016 to 2017, and an 88 percent increase in Idaho."
— Senate Majority Leader Mitch McConnell (R-Ky.) said he spent part of the weekend in Arizona with Sen. John McCain (R), telling senators on the floor yesterday he “didn’t want to miss the opportunity to tell him what his friendship meant to me" as McCain fights brain cancer.
“John and Cindy and I had a chance to sit on their back porch and reminisce,” McConnell said, our colleague Dave Weigel reports. “He still had plenty to say about work, I assure you. He misses his colleagues. He’d rather be here. And I told him we miss him, too. All of the jokes, the smart-alecky comments — he’s a joy to be around.”
Meanwhile, the controversy over a White House aide’s derisive remark about McCain continued into another day. White House spokesman Raj Shah said Monday that Trump communications aide Kelly Sadler had been “dealt with internally” after remarking that McCain’s opposition to the president’s CIA nominee didn’t matter because “he’s dying anyway.” Trump tweeted blasting the leakers revealing internal remarks as “traitors and cowards.”
The so-called leaks coming out of the White House are a massive over exaggeration put out by the Fake News Media in order to make us look as bad as possible. With that being said, leakers are traitors and cowards, and we will find out who they are!— Donald J. Trump (@realDonaldTrump) May 14, 2018
On the fifth day the White House declined to publicly apologize for the remarks, some Senate Republicans blasted the non-response, per Politico’s Burgess Everett and Eliana Johnson. “Just out of common decency they should apologize. And the person who said it should apologize. It’s wrong,” Sen. Rob Portman (R-Ohio) said.
— Some of the biggest recent health-care mergers have involved nonprofit hospitals linked to the Catholic Church, meaning church officials have had a say in what mergers go forward. Now the Vatican is getting involved, the Wall Street Journal’s Melanie Evans reports.
“A proposed union between Catholic Health Initiatives and Dignity Health would create one of the largest U.S. hospital owners, with $28 billion in annual revenue," Melanie writes, noting that the archbishops who have already OKed the deal agreed in December to seek the Vatican’s approval. But the Vatican hasn’t yet made a decision.
What happens if the church disapproves? “Pushback from the church can derail a deal or send people back to boardrooms to renegotiate the terms,” Melanie writes. “The 2012 sale of a Catholic hospital by Mercy, based in St. Louis, to a non-Catholic, for-profit company, ended after parties involved said they anticipated ‘continued challenges’ to approvals needed from the Vatican and Federal Trade Commission.”
— First lady Melania Trump underwent a medical procedure for a “benign kidney condition” at Walter Reed National Military Medical Center yesterday and will remain in the hospital for the rest of the week, our colleague Jenna Johnson and Lenny Bernstein report. “The procedure was successful and there were no complications,” her communications director Stephanie Grisham said in a statement. “The first lady looks forward to a full recovery so she can continue her work on behalf of children everywhere.”
The statement referred vaguely to an “embolization procedure to treat a benign kidney condition," which involves inserting a catheter as part of a procedure to block a blood vessel and cut off blood supply to the affected area, Jenna and Lenny explain. No additional details about the first lady’s procedure were disclosed.
The president tweeted yesterday:
Heading over to Walter Reed Medical Center to see our great First Lady, Melania. Successful procedure, she is in good spirits. Thank you to all of the well-wishers!— Donald J. Trump (@realDonaldTrump) May 14, 2018
— Former Senate Democratic leader Harry Reid (Nev.) has been diagnosed with pancreatic cancer and underwent surgery yesterday to remove his tumor, our colleague Seung Min Kim reports. The 78-year-old former Nevada senator had surgery at Johns Hopkins Cancer Center in Baltimore and is planning to have hemotherapy treatments.
“His doctors caught the problem early during a routine screening and his surgeons are confident that the surgery was a success and that the prognosis for his recovery is good,” the Reid family said in a statement. “He is now out of surgery, in good spirits and resting with his family. He is grateful to his highly skilled team of doctors and to all who have sent and continue to send their love and support.”
Reid led the Senate Democratic Caucus for a dozen years before he retired in early 2017.
— Yesterday, the WHO announced a plan to eliminate the use of trans fats from food supplies around the world by 2023. The organization believes it could save about 10 million lives by stopping the use of the industrially produced oil that has been linked to millions of premature deaths, the New York Times’s Andrew Jacobs reports. The United States, Canada, Britain, Denmark and Switzerland are among the countries that have already moved to restrict or completely ban trans fats, he adds. All products sold in the United States must be free of industrially produced trans fats.
“Artificial trans fats, better known to many American consumers as partially hydrogenated vegetable oil, have contributed to a half million deaths a year, many of those in developing countries ill-equipped to address the health threats posed by a product cherished for its low price and long shelf life,” Andrew writes. “Popularized in the 1950s, and once lionized as a healthy alternative to the saturated fats found in butter and lard, trans fats have been implicated in sudden heart attacks and strokes, but they are also associated with an increased risk for Type 2 diabetes and even infertility in women.”
— The Susan B. Anthony List announced yesterday President Trump is scheduled to speak at the organization’s 11th annual Campaign for Life Gala. During next Tuesday’s events, senior White House counselor Kellyanne Conway will receive the 2018 Distinguished Leader Award from the antiabortion group and House Majority Whip Steve Scalise (R-La.) is also scheduled to speak.
A few more good reads from The Post and beyond:
POST PROGRAMMING: This morning, The Post is holding a live news event featuring government officials, health-care industry leaders and public health advocates who will address how challenges posed by chronic diseases, access to health insurance and the future of Medicaid will affect the health of Americans. Watch the live stream here.
- The Senate Health, Education, Labor and Pensions holds an oversight hearing on the 340B program.
- The National Committee on Vital and Health Statistics holds a meeting on Tuesday and Wednesday.
- The American Enterprise Institute holds a hearing on fixing health care on Wednesday.
- The House Veterans Affairs Committee holds a member day hearing on Wednesday.
- AHIP holds a webinar on clinical data on Wednesday.
- Reps. Jackie Walorski (R-Ind.) and Terri Sewell (D-Al.) sponsor a hill briefing on “Increasing Patient Access to Non-Opioid Pain Management Therapies” on Wednesday.
- The House Energy and Commerce is scheduled to hold a markup on legislation to combat the opioid crisis on Thursday.
- The House Oversight and Government Reform Committee holds a hearing on a “Sustainable Solution to the Evolving Opioid Crisis: Revitalizing the Office of National Drug Control Policy” of Thursday.
- The Advisory Board holds a webinar on combating clinician burnout on Thursday.
- The FDA’s Vaccines and Related Biological Products Advisory Committee holds a meeting on Thursday.