Tagged Trump Administration

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Did you guys get as big a kick out of the #healthpolicyvalentines hashtag as I did? (I feel I’m talking to the right crowd here.) They’re quite delightful, including this timely one from KHN’s own Rachel Bluth: “Not even a PBM could get in the middle of our love.”

On to the news from the week.

Thursday was a somber day for many as the country marked the anniversary of the Parkland, Fla., mass shooting at Marjory Stoneman Douglas High School that left 17 dead.

On the eve of the anniversary, the House Judiciary Committee approved two bills that would expand federal background checks for gun purchases. Although the legislation faces certain demise in the Senate, it is the first congressional action in favor of tightening gun laws in years. In the votes you see echoes of a recent trend: Lawmakers are no longer treating gun control as “the third rail in politics.” The difference is stark if you look at just over 10 years ago when then-candidate Barack Obama was sending out mailers assuring voters he supported the Second Amendment.

Politico: House Democrats Make First Major Move to Tighten Gun Laws

The Associated Press: Parkland Anniversary Highlights Democratic Shift on Guns

There were too many heartbreaking anniversary stories to highlight just one, but a project worth checking out is one from The Trace, a nonprofit news organization that reports on gun violence. In the year since Parkland, nearly 1,200 more children have lost their lives to guns. The Trace brought together more than 200 teen reporters from across the country to remember those killed not as statistics, but as human beings with rich histories.

14 Children Died in The Parkland Shooting. Nearly 1,200 Have Died From Guns Since.

A handy reference: The good people at The Tampa Bay Times and the AP put together a useful list of all the gun laws that have been enacted in the country since the shooting.

Tampa Bay Times and Associated Press: Here Is Every New Gun Law in the U.S. Since the Parkland Shooting


There are some lawmakers on the Hill who are almost giddy to hold hearings on “Medicare-for-all” — and they’re not Democrats. Republicans have been struggling to find a winning stance on health care, ever since Dems’ midterm victories, which were attributed in part to their stance on the issue.

For the previously floundering GOP lawmakers, MFA is practically a gift-wrapped present that fell right into their laps. They’re confident they can frame the idea as reckless, radical and expensive, and pick off moderate voters who want to keep their insurance the way it is. Democratic leadership blasted the GOP’s calls for hearings as “disingenuous,” but MFA supporters were raring to duke it out — verbally, of course. “They think it’s going to be a ‘gotcha’ moment,” said Rep. Pramila Jayapal (D-Wash.) in Politico’s coverage. “But they have been wrong on this and continue to be wrong on it.”

Politico: Republicans Can’t Wait to Debate ‘Medicare For All’

Meanwhile, Democrats introduced legislation this week that would allow people over 50 to buy in to Medicare. The measure is much more politically palatable than MFA, and its sponsors are selling it is a realistic and incremental step in the direction toward universal coverage.

Politico: Push for Medicare Buy-In Picks Up With ’50 and Over’ Bill


Here’s something you don’t hear every day: Republicans and Democrats maybe (just maybe!) have found some common ground on the health law. As part of a package of bills to shore up the Affordable Care Act, Democrats are proposing slapping some consumer warnings on short-term plans. The hint of bipartisanship in the air, though, was limited to the advisories — Republicans were not fans of the rest of the changes proposed.

Modern Healthcare: Short-Term Health Insurance Plans May Get Consumer Warnings


Advocates deem Utah’s move to limit voter-approved Medicaid expansion as a “dark day for Democracy.” The governor and lawmakers who rushed through the restrictions to the expansion, however, say the work requirements and caps are necessary to make it sustainable for the state.

The Associated Press: Utah Reduces Voter-Backed Medicaid Expansion in Rare Move


As 2020 comes into focus, the abortion debate is definitely on the front burner for President Donald Trump, who has seized on recent controversies over so-called late-term abortions. This week, Trump and White House officials met with advocates, including Susan B. Anthony List President Marjorie Dannenfelser. While the discussions weren’t open to journalists, Dannenfelser confirmed that Trump was keenly interested in the issue. “The national conversation about late-term abortion … has the power to start to peel away Democrats, especially in battle grounds,” Dannenfelser said in The Hill’s coverage.

The Hill: Trump Offers Preview of Abortion Message Ahead of 2020


There was some movement in the agencies this week that should be on your radar:

— The Food and Drug Administration has announced it’s cracking down on the $40 billion supplement industry, especially targeting diseases that really should require medical care. Right now, that landscape is pretty much the Wild Wild West, where anything goes. And consumers don’t realize that.

The New York Times: F.D.A. Warns Supplement Makers to Stop Touting Cures for Diseases Like Alzheimer’s

— The Environmental Protection Agency has released its plan to address long-lasting toxins in drinking water. Activists were not impressed, saying the “action plan” was quite short on action.

Reuters: U.S. Unveils Plan to Control Some Toxins in Drinking Water, Sets No Limits

— The Centers for Medicare & Medicaid Services released two major proposed regulations that are meant to help ease patients’ access to their health care records. Right now, many health care providers and hospitals offer patient portals, but they often lack material such as doctor notes, imaging scans and genetic-testing data. Sometimes they’ll even charge for the data. The rules would address restrictions such as those.

The Wall Street Journal: New Rules Could Ease Patients’ Access to Their Own Health Records


In a sign of the growing awareness about the United States’ maternal mortality problem, the task force that sets the standards insurers are required to follow is expanding its guidance when it comes to depression during and after pregnancy. The U.S. Preventive Services Task Force already recommends that doctors screen pregnant women and new mothers, but the old guidelines focused on patients who were experiencing symptoms. The new advice is more proactive about addressing women who may be at risk.

The Wall Street Journal: New Mothers at Risk of Depression to Get Counseling Services, Covered By Insurance, Under New Guidelines


It’s a well-established fact that doctors have an unconscious bias when it comes to race and pain — one that leaves many minority patients undertreated and undermedicated. What’s interesting is to see how that disparity has shaped the opioid epidemic in the country — the ones that wreaked havoc on white communities.

Los Angeles Times: Why Opioids Hit White Areas Harder: Doctors There Prescribe More Readily, Study Finds

While all eyes are on the massive consolidated opioid lawsuit in Ohio that’s being compared to the Big Tobacco reckoning of the ’90s, this little case in Oklahoma might steal its thunder.

Stateline: Pay Attention to This Little-Noticed Opioid Lawsuit in Oklahoma


In the miscellaneous file for the week:

• A powerful investigation from The Wall Street Journal and Frontline uncovers the history behind an Indian Health Service doctor who was accused of molesting Native Americans yet allowed to continue practicing for decades. Where did it go wrong?

The Wall Street Journal: HHS to Review Indian Health Service After Revelations on Pedophile Doctor

• Rural hospitals are collapsing everywhere, leaving vulnerable residents stranded in health deserts. It can be devastating for towns to watch their hospitals die. Ducktown, Tenn., offers a snapshot of what’s playing out in states all across the country.

Nashville Tennessean: Tennessee Rural Hospitals Are Dying. Welcome to Life in Ducktown

• Employer-sponsored health care is often held up as the gold standard. But is it really that great?

CNN: Employer Health Plans Cover Less Than You Think, Study Finds

• I vividly remember the global fear surrounding the bird flu back in the aughts. People were panicking and countries were stockpiling medical supplies, as everyone braced for an epidemic reminiscent of the catastrophic 1918 Spanish flu. But then nothing happened. So … where’d it go?

Stat: What Happened to Bird Flu? How a Threat to Human Health Faded From View


Early numbers show that the flu vaccine is doing a pretty good job this year, so remember it’s not too late to get your shot! And have a great weekend!

Utah’s Novel Plan For Medicaid Expansion Opens Door To Spending Caps Sought By GOP

Utah this week became the 35th state to approve expanding Medicaid under the Affordable Care Act, but advocates for the poor worry its unusual financing could set a dangerous precedent and lead to millions of people losing coverage across the country.

That’s because the plan includes unprecedented annual limits on federal and state spending.

Those restrictions would be a radical change for Medicaid. Since it began in 1966, the state-federal health program for low-income residents has been an open-ended entitlement for anyone who meets eligibility criteria. State and federal spending must keep pace with enrollment.

Joan Alker, executive director of the Georgetown University Center for Children and Families, is concerned that the state and federal Medicaid funding caps can limit how many people are enrolled and what services they receive. She said no state has before tried to cap its own funding.

“This is a way for the state to look like it’s doing expansion when they are really doing very little,” she said.

If Utah’s plan is approved, Alker added, other states that have already expanded Medicaid and some that are considering it will likely seek to strike a similar deal.

Limiting spending on Medicaid has been a longtime goal of fiscal conservatives, but opposition to the idea helped blow up  Republican efforts to repeal and replace the ACA in 2017.

Also fueling criticism: The law signed by Utah Gov. Gary Herbert on Monday expands Medicaid only to people earning up to 100 percent of the federal poverty level instead of the 138 percent mark set by the ACA and approved by Utah voters in a referendum supporting expansion in November. Both the Obama and Trump administrations have refused in the past to accept that condition.

The proposal also includes a work requirement for adults who gain coverage through the expansion.

Utah’s proposal needs federal approval, and state officials said they hope to have that in time to expand Medicaid to 90,000 adults on April 1.

The state expects to adopt annual spending caps after negotiations with the Trump administration.

Congressional Republicans and President Donald Trump tried to cap federal Medicaid payments as part of their health law repeal efforts in 2017. But that move met stiff opposition from Democrats, hospital and patient advocates and some Republican lawmakers. They warned it would lead to cuts in benefits and enrollment.

Utah’s proposal to limit federal spending was necessary to get the Trump administration to approve its application to only partially expand Medicaid, the state’s top Medicaid official said.

“We were looking for a way to make our waiver more attractive to the federal government,” said Nathan Checketts, Utah’s Medicaid director.

He said the Trump administration last year was skeptical of the state’s proposal to expand Medicaid to adults with incomes below 100 percent of the federal poverty level — about $12,500 annual income for an individual — instead of 138 percent of the poverty level, about $17,000 in annual income. That’s because it would mean higher federal spending, since people earning between 100 percent and 138 percent of poverty would be eligible for federal subsidies to help pay for premiums for insurance they buy on the ACA exchange.

By capping funding at a negotiated per capita rate, the federal government could better control its spending, Checketts said.

Under Trump, the federal Centers for Medicare & Medicaid Services has not approved requests by Arkansas and Massachusetts to get the higher federal match rate for partial expansion.

CMS, Checkett added, has been open to a deal since after Election Day. “They’ve become more receptive to our request than they were last year, but there are no guarantees,” he said.

Under the proposed deal, the federal government would pay 90 percent of the costs for anyone coming into Medicaid through expansion — the rate set by the ACA. In traditional Medicaid, the state receives a 70 percent federal match.

The federal spending cap would vary based on how many people are enrolled under expansion. If the costs for covering the expansion population exceeded the federal spending cap, the state could limit how many people it enrolled, Checketts said.

The law also includes a state funding cap so Utah officials can limit enrollment if spending were to exceed the budget, Checketts said. The federal government would also have to approve a state spending cap.

“The state has to balance its budget every year, and this allows the state to align its budget and a certain amount of money to put toward this population and not any more,” he said.

If CMS does not grant the waiver for a partial expansion, the bill requires the state to establish a full expansion in 2020.

Jessie Mandle, senior health policy analyst for Voices for Utah Children, an advocacy group, said the plan is tough to swallow for advocates who have been fighting for expansion for more than six years.

“This will create more barriers and restraints to care,” she said. “This was not the way voters chose to expand.”

Utah’s plan to seek a per capita spending cap comes even though the state’s per capita Medicaid spending is among the lowest, according to a report last year by the Utah Foundation, a nonpartisan research group.

The average cost for each Medicaid enrollee in Utah was $5,326 in 2014, the most recent year for which that figure is available, the report found. That number was the 10th lowest in the United States.

Nationwide, Utah also had the lowest percentage of its population enrolled in Medicaid as of 2016, the report said.

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Also known as the day President Donald Trump is getting his second annual physical. Last year, Dr. Ronny L. Jackson attributed the president’s “excellent health” to good genes and God. Will this year be different with a new physician?

The headliner from this week was obviously the State of the Union address, so let’s get right to it.

Trump’s pledge to end the HIV epidemic was greeted with cautious optimism — laced with a heavy dose of skepticism. The administration’s plan involves targeting HIV hot spots and increasing access to medications that treat and prevent the disease. However, the lack of specific details in Trump’s address have HIV advocates nervous. “To date, this administration’s actions speak louder than words and have moved us in the wrong direction,” said AIDS United.

The Associated Press: Trump Launching Campaign to End HIV Epidemic in US by 2030

Kaiser Health News: Trump Pledges To End HIV Transmission By 2030. Doable, But Daunting.

When it comes to high drug prices, Trump had very simple instructions for Congress: “Do more.” The response, as you can imagine, was mixed. Some Democrats saw it as an invitation to work on an issue that could be one of the few bipartisan successes emerging from the current Congress. Others don’t have any interest in getting on board with the president’s policies — which include capping U.S. drug payments based on prices paid abroad.

Stat: Democrats Can’t Decide How to React to Trump’s Call for ‘More’ on Drug Pricing

Meanwhile, in his address, Trump used a pretty wonky (as in, in the weeds) metric to praise his administration’s efforts on bringing down drug prices. The consumer price index, at best, doesn’t tell the full story of costs, and experts say that, given how complicated the system has become (i.e. with rebates), it has outlived its usefulness.

Stat: Trump Claims Drug Prices Have Fallen. But He’s Cherry-Picking That Data

Recent controversies over abortions provided Trump the perfect opportunity, as he starts to gear up for 2020, to give a little love to a highly valued segment of his base. Virginia’s governor had made comments last week that led to accusations that he supported infanticide; and New York just passed a bill that protects against efforts to roll back Roe v. Wade. Trump used those incidents as a springboard to call on Congress to ban “late-term abortions.” And the language he used in the speech — “All children — born and unborn — are made in the holy image of God” — is being seen as a play for evangelical voters.

The Associated Press: With Anti-Abortion Push, Trump Woos Evangelicals Again

Doctors weighed in on the debate with this reality check: Clinically, there is no such thing as a “late-term abortion.” See what else they say the president got wrong.

The New York Times: What Is Late-Term Abortion? Trump Got It Wrong

Childhood cancer also got a shout-out in the SOTU. Although it has an 80 percent cure rate, scientists say that number is skewed by the tremendous progress that’s been made against childhood leukemia. Other pediatric cancers have a long way to go. (And so they are welcoming the $500 million with open arms and a distinct list of ideas.)

Stat: Scientists Have Ideas to Spend Trump’s Money for Childhood Cancer


Former Rep. John Dingell died on Thursday at age 92. Lawmakers and politicians praised the country’s longest-serving congressman, calling him a “beloved pillar of the Congress” who is leaving behind “a towering legacy.” One common thread in the heartfelt messages was the impact he had on America’s health care. “He had a long tradition of introducing legislation on the first day of each new Congress to guarantee health care for every single American,” former President Barack Obama wrote. “Because of him, we’ve come closer to that vision than ever before. And when we finally achieve it — and we will — we’ll all owe him our gratitude.”

The Washington Post: Colleagues, friends remember John Dingell, an ‘American legend’ and ‘beloved pillar of Congress’


Fresh off their midterm victories, Democrats are wasting no time setting up hearings to secure protections for people with preexisting conditions. Any legislation would be mostly symbolic because it would face an all-but-certain death in the Republican-controlled Senate, but it solidifies talking points that have been successful for Democrats recently.

The New York Times: Democrats Unite to Begin Push to Protect Pre-Existing Condition Coverage


If you’re confused about Trump’s rebate proposal join the (very crowded) club. But here’s the bottom line: Most patients will pay a little more since their premiums will go up (because insurers would no longer be able to apply rebate money from the drugs to lower premiums). However, people who take outrageously expensive medication will get relief. Experts say the trade-off is worth it.

The New York Times: How Trump’s Latest Plan to Cut Drug Prices Will Affect You

How does a drug that, until December, was free to patients now have a $375,000 price tag? Paint Sen. Bernie Sanders (I-Vt.) … curious … to say the least.

Stat: Sanders Calls Price of a Rare Disease Drug ‘Immoral Exploitation’


Court watchers were eagerly awaiting the Supreme Court’s decision on a Louisiana admitting-privileges law — the first real gauge of how the new dynamics of the court will play out with abortion decisions. The Louisiana restrictions are quite similar to ones knocked down in a 2016 ruling, but the court is also more conservative than it was at that time. For now, Chief Justice John Roberts disappointed his conservative colleagues by joining with the liberal justices in issuing a stay on the law. The decision likely means the court will take up the issue in its next term, which starts in October.

The New York Times: Supreme Court Blocks Louisiana Abortion Law


Medicaid expansion advocates were ecstatic last year when ballot initiatives proved a successful way to circumnavigate red-state legislatures that had been blocking changes to the program. This week, a bucket of cold water has doused that enthusiasm as lawmakers in both Utah and Idaho scramble to counter the expansion as much as possible. While the proposals — like adding work requirements — gain popularity in red states across the country, the fact it’s happening at all after voters OK’d the expansion highlights the reality that ballot initiatives can do only so much.

The New York Times: In Utah and Idaho, G.O.P. Looks to Curb Medicaid Expansions That Voters Approved


In a startling, horrifying trend, veterans have been killing themselves in VA parking lots in what experts see as a protest against a system that failed them. The latest was a Marine colonel who, dressed in his uniform blues and medals, sat on top of his military and VA records and shot himself with a rifle outside the Bay Pines Department of Veterans Affairs. “It’s very important for the VA to recognize that the place of a suicide can have great meaning. There is a real moral imperative and invitation here to take a close inspection of the quality of services at the facility level,” said Dr. Eric Caine, director of the Injury Control Research Center for Suicide Prevention at the University of Rochester.

The Washington Post: Parking Lot Suicides at Veterans Hospitals Prompt Calls for Better Staff Training, Prevention Efforts

Meanwhile, USA Today released a comprehensive analysis on the quality of VA hospitals versus civilian ones. Some of the scores came back positive (death rates, on the whole, were lower at VA facilities); others that look at preventable infection rates and bedsores hinted at neglect. USAT offers a very cool look-up tool if you want to see how your clinic fared.

USA Today: Death Rates, ER Waits: Where Every VA Hospital Lags, Leads Other Care


An HHS official is arguing that pulling separated migrant children from their sponsor homes to reunite them with their families would do more harm than good psychologically at this point. Jonathan White, an official leading HHS’ reunification efforts, said in a court filing that it would make more sense for the government to focus on children who were still in custody. The ACLU called the position a “shocking concession that it can’t easily find thousands of children it ripped from parents, and doesn’t even think it’s worth the time to locate each of them.”

The Associated Press: US Sees Limitations on Reuniting Migrant Families


In the miscellaneous file for the week:

• There’s a long history of mistrust between the African-American community and medical professionals, and Virginia Gov. Ralph Northam’s photo involving black face pressed sharply against that never-healed wound. (At the time, Northam was graduating from medical school on his way to becoming a pediatrician.)

The Associated Press: Blackface Photo Reopens Long History of Bigotry in Medicine

• Anecdotal evidence was thick on the ground that women were seeking emergency contraception in the wake of Trump’s election victory. Now there are numbers to back it up.

The Hill: Demand for Certain Forms of Contraception Increased After Trump’s Election: Study

• Could an infamous party drug really help quiet suicidal ideation in the midst of an ever-worsening crisis? This fascinating history on the use of ketamine is well-worth the read.

Bloomberg: Ketamine Could Soon Be Used to Treat Suicidal Ideation

• “It’s like throwing a match into a can of gasoline,” experts say of the measles outbreak in the Pacific Northwest. Are they just the norm now? And why were there so many kids who weren’t vaccinated?

The New York Times: ‘A Match Into a Can of Gasoline’: Measles Outbreak Now an Emergency in Washington State

CNN: Measles Rarely Kills in the US — But When It Does, Here’s How 


I was delighted this morning over the fact that scientists had a major breakthrough in creating a way to take insulin in pill form because of … turtles! Last week hedgehogs, this week turtles. I swear the Breeze isn’t turning into an animal news newsletter (or is it?). Have a great weekend!

Trump’s Pediatric Cancer Crusade A Drop In Bucket Compared With Past Presidential Pitches

President Donald Trump announced Tuesday during his State of the Union address that he was asking Congress to allocate $500 million over the next 10 years for pediatric cancer research.

Organizations such as the American Cancer Society viewed the investment as a positive step.

“Any increase in current funding levels is a good thing,” said Keysha Brooks-Coley, the vice president of federal advocacy at the Cancer Action Network, the advocacy arm of the American Cancer Society. “We have to start someplace, and the president’s announcement puts us there.”

What’s unclear is how meaningful the increase is in relation to current federal spending on childhood cancer research.

The National Institutes of Health estimates its 2019 spending in this area to be $462 million, according to research portfolio data. So, $500 million over 10 years, or an average $50 million a year, amounts to a bit more than a 10 percent increase.

House Speaker Nancy Pelosi considered Trump’s proposed funding level insufficient, according to a congressional aide who was in a closed-door meeting Wednesday with her.

“Five hundred million dollars over 10 years — are you kidding me?” Pelosi reportedly said during the meeting. “Over 10 years, $500 million, $50 million a year. That’s like — what?! Who gave him that figure? It’s like the cost of his protection of his Mar-a-Lago or something.”

But a spokeswoman at the National Cancer Institute (NCI), which is a part of the NIH, told KHN it would “embrace the opportunity to lead a national initiative on childhood cancer.” However, she added, it was not clear whether the $500 million would come from completely new funding, or would include the already allotted funds — a point that she hopes would be clarified by the president’s soon-to-be released 2020 budget.

For now, a senior administration official told KHN “it is common practice that we don’t comment on deliberative or pre-decisional information prior to the release of the President’s FY2020 budget.”

To put it in perspective: The $500 million figure pales in comparison to other medical research initiatives that previous presidents have outlined amid the pomp and circumstance of this annual speech.

Barack Obama announced during his 2016 State of the Union that he wanted to “make America the country that cures cancer once and for all,” launching what came to be known as the “Cancer Moonshot” initiative. In his initial announcement, Obama proposed $1 billion to be parceled out over fiscal years 2016 and 2017.

That amounts to an average of $500 million over two years.

(Story continues below.)

But presidents don’t always get all they ask for. In December 2016, Congress passed the 21st Century Cures Act, which instead allotted $1.8 billion to the Moonshot effort over seven years. That averages to about $257 million for each of those years, though it’s up to Congress each year to decide on the Moonshot’s actual appropriation.

Obama also spearheaded the BRAIN initiative, which he announced in April 2013 and alluded to during the 2013 State of the Union. The BRAIN Initiative provides funding for brain-related research, including Alzheimer’s disease, traumatic brain injuries and epilepsy.

Obama wanted $100 million for fiscal year 2014, which he got. He also wanted funding to increase annually, which it did, until fiscal year 2017.

By far the largest health-related presidential pledge of the past 15 years was George W. Bush’s 2003 request for funding to end the global HIV/AIDS epidemic. During the 2003 State of the Union, Bush asked Congress “to commit $15 billion over the next five years, including nearly $10 billion in new money, to turn the tide against AIDS in the most afflicted nations of Africa and the Caribbean.”

The public health program came to be known as the President’s Emergency Plan for AIDS Relief, or PEPFAR. Averaged out, Bush’s proposed spending was $3 billion a year. (In inflation-adjusted dollars, that would be $4.09 billion today.) Funding levels for PEPFAR surpassed $15 billion by 2008.

Last year, Trump signed the Childhood Cancer STAR Act, which appropriates $30 million a year for the NIH and the Centers for Disease Control and Prevention to spend on research for childhood cancer. Under Trump, the NIH’s budget has increased from $36 billion in 2017 to an estimated $39 billion in 2019.

According to the American Cancer Society, pediatric cancer makes up fewer than 1 percent of all cancers diagnosed each year. The NCI says that cancer is the leading cause of death by disease for children past infancy, and in 2018 it was estimated that 1,780 children would die from various forms of the disease.

Podcast: KHN’s ‘What The Health?’ A ‘Healthy’ State Of The Union

Health policy played a surprisingly robust role in President Donald Trump’s 2019 State of the Union address.

The president laid out an ambitious set of health goals in his speech Tuesday to Congress and the nation, including reining in drug prices, ending the transmission of HIV in the U.S. during the next decade and dedicating more resources to fighting childhood cancer.

Meanwhile, in Utah and Idaho, two of the states where voters last fall approved expansion of the Medicaid health program, Republican legislatures are trying to scale back those plans.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Margot Sanger-Katz of The New York Times and Alice Ollstein of Politico.

Among the takeaways from this week’s podcast:

  • The Trump administration is proposing to change the drug rebates in Medicare so that consumers purchasing the medicines get more of the savings and the middlemen negotiating the deals get less. But that effort could lead to increased insurance premiums — a consequence that could have significant political repercussions.
  • Trump’s pledge to end HIV transmissions in 10 years was a bit of a surprise since the disease had not been much of a priority in earlier moves by the administration.
  • The efforts to restrict Medicaid expansion approved by voters in Utah and Idaho show the limitations of referendums and could impact a move to get a Medicaid expansion question on the Florida ballot.
  • An intriguing study this week showed that medications to treat cardiac problems saved Medicare money. The results were surprising because generally public health officials suggest that prevention is important to improve health but doesn’t necessarily save money.

Also this week, Rovner interviews KHN senior correspondent Phil Galewitz, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a man with a minor problem — fainting after a flu shot — and a major bill. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: NPR’s “Texans Can Appeal Surprise Medical Bills, But the Process Can Be Draining,” by Ashley Lopez

Margot Sanger-Katz: The Los Angeles Times’ “In Rush to Revamp Medicaid, Trump Officials Bend Rules That Protect Patients,” by Noam N. Levey

Anna Edney: Bloomberg News’ “Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate,” by Cynthia Koons and Robert Langreth

Alice Ollstein: The Washington Post’s “’It Will Take Off Like a Wildfire’: The Unique Dangers of the Washington State Measles Outbreak,” by Lena H. Sun and Maureen O’Hagan

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale

The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past two years, the result of its actions to streamline a cumbersome process and combat anti-competitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Donald Trump noted at a White House event last month. The Food and Drug Administration has approved more than 1,600 generic drug applications since January 2017 — about a third more than it did in the last two years of the Obama administration.

But more than 700, or about 43 percent, of those generics still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36 percent of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who co-sponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more, but suspects anti-competitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner Brilinta and HIV medication Truvada. They also include six different generic versions of Nitropress, a heart failure drug, whose price spiked 310 percent in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33 percent of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10 percent a year, said Scott Knoer, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past two years haven’t been brought to market.

Erin Fox, a pharmacist at the University of Utah who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list — like dextrose 10 percent injection, to treat patients with low blood sugar — would have been helpful to combat shortages the past few years. “This comes up with shortages a lot — it looks like there are more suppliers than there really are,” Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting six, seven, eight years,” said Robert Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects, or because a more effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anti-competitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, Gottlieb said, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti, an associate professor at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Conti said. Then they can launch and hike the price.

To be sure, the FDA under Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in — once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Davis said. Consolidation has led to three large buying groups covering 90 percent of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”

Methodology

To identify approved drugs that have not reached the market, KHN used the FDA’s Orange Book database — as of Jan. 2 — to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past two years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.

Trump Pledges To End HIV Transmission By 2030. Doable, But Daunting.

Noting that science has “brought a once-distant dream within reach,” President Donald Trump on Tuesday night pledged to eliminate HIV transmission within 10 years.

“We have made incredible strides, incredible,” Trump said in the annual State of the Union address. “Together, we will defeat AIDS in America and beyond.”

It’s a goal long sought by public health advocates. But even given the vital gains made in drug therapies and understanding of the disease over nearly 40 years, it is not an easy undertaking.

“The reason we have an AIDS epidemic is not just for a lack of the medication,” said Dr. Kenneth Mayer, medical research director at the Boston LGBT health center Fenway Institute. “There are a lot of social, structural, individual behavioral factors that may impact why people become infected, may impact if people who are infected engage in care and may impact or affect people who are at high risk of HIV.”

Health and Human Services Secretary Alex Azar, who provided details of the initiative after Trump’s announcement, said the administration will target viral hot spots by providing local groups more resources, using data to track the spread of the disease and creating local task forces to bolster prevention and treatment.

Neither Azar nor other federal officials who briefed reporters offered cost estimates for the program.

Azar said the plan seeks to reduce new infections by 75 percent in the next five years and 90 percent in the next decade.

That goal is predicated on growing use of current medications that suppress the virus to such low levels that it is not transmitted during sexual intercourse. PrEP, a drug combination available to individuals with a negative HIV status but may become infected, can reduce their risk of getting the virus by 97 percent, Azar said.”

“This is not the HIV epidemic of the 1990s,” said Terrance Moore, acting executive director of NASTAD, a nonprofit organization that represents officials who administer HIV and hepatitis programs. “We have the tools to end this epidemic.”

Gay and bisexual men made up two-thirds of the nearly 40,000 new HIV cases in 2017, but one clear signal of that difference in the epidemic today is the geography. The nation’s HIV hotbeds are no longer located just in coastal metropolitan areas. In 2017, more than half of the new cases were diagnosed in Southern states.

HHS said it will focus its efforts on the heart of the epidemic: 48 counties across 19 states; the District of Columbia; San Juan, Puerto Rico; and rural areas in seven states, many of which are in the South.

The new federal initiative would expand PrEP access in community health clinics for low-income patients and quickly refer any new clinic patients with HIV to specialized care.

Medications alone are not the answer. Lawmakers must have the political will to move forward with policies based in science, said Moore. Existing programs do not provide enough infrastructure to achieve this goal, he added.

“You can’t be simultaneously attacking and undermining the needs of these communities, while claiming that you want to support them and end the AIDS epidemic,” said Scott Schoettes, HIV project director for the LGBT advocacy group Lambda Legal.

The Trump administration has pursued policies that may hinder the president’s goal. And efforts in the South face additional challenges, like higher levels of poverty, difficulty providing health care in rural areas and historical racial tension.

“I don’t think that these things are things that we cannot overcome,” said Greg Millett, vice president and director of public policy at the HIV research foundation amfAR. “But I also think that we need to be very clear about what the obstacles are and to start thinking now innovatively about how we’re going to be able to obviate them.”

Here are some of the challenges that experts said the president’s plan could face.

Health Insurance

Insurance coverage plays a crucial role in keeping HIV patients healthy.

Comprehensive insurance helps patients access the expensive medications needed to keep the virus under control and vital tests to check on virus levels and white blood cell counts — key health indicators. HIV patients are also often susceptible to infections because the virus compromises the immune system. And they tend to have higher rates of mental health conditions, which could affect their ability to adhere to HIV medication if left untreated.

The Affordable Care Act opened up coverage for thousands of HIV patients with its guarantee of insurance for people with preexisting conditions, but many Republican officials are still calling for the law’s repeal.

In addition, the ACA’s Medicaid expansion led to a substantial jump in the number of people with AIDS who got that coverage, according to the Kaiser Family Foundation. But many states, especially in the South, have not expanded Medicaid. (Kaiser Health News is an editorially independent program of the foundation.)

A federal judge in Texas in December ruled the ACA unconstitutional in a lawsuit waged by a faction of conservative states and supported by the president.

“If you’re not going to provide it through the Affordable Care Act,” Schoettes said, “then there needs to be something that’s as comprehensive in terms of getting people care.

Housing

Although the federal government provides some housing assistance for people with HIV, it does not fill the need.

Those who are homeless or have unstable housing have lower access to HIV medications and poorer treatment outcomes.

A study from the Centers for Disease Control and Prevention found that among individuals living with HIV in certain impoverished urban areas across the country, the lower the household income, the higher the rate of HIV in the area. 

The federal government provides assistance through a program called Housing Opportunities for Persons With AIDS, known as HOPWA. In 2016, HOPWA changed its  funding formula to better allocate its resources to Southern areas hardest hit by HIV.

However, some of these HOPWA programs have waiting lists that can extend years. The nation is also experiencing an affordable housing shortage, which further limits options for low-income individuals living with HIV and their families.

Stigma And Mistrust

Experts continue to cite stigma as a key obstacle for treatment. Twenty-six states have laws that penalize an HIV patient for exposing someone to the virus, including 19 that require people who are aware they are infected to notify sexual partners and 12 that mandate disclosure to needle-sharing partners, according to the CDC.

The problems extend to doctors and medical staff. One study, published in 2016, found widespread stigma against HIV patients among health care staff in Alabama and Mississippi, especially among whites and men.

Gina Brown, a community engagement manager for the Southern AIDS Coalition, in part blames the culture of the South, where religious beliefs often clash with gay culture, for perpetuating these problems. “We are still in Bible Belt country, where religion plays a huge part in how we talk about sex or not talk about sex,” she said.

But federal policies, such as the Trump administration’s ban on transgender men and women serving in the military, also play a role.

Federal officials acknowledged these difficulties and affirmed the program would not discriminate against transgender patients.

In addition, minority communities hard hit by the HIV epidemic harbor lingering distrust toward the medical system due to historical abuses such as the Tuskegee syphilis trials, said Mayer.

Injection Drug Use

The scourge of addiction has killed tens of thousands across the nation, spread hepatitis C and is now leading to spikes in HIV transmission, as drug users share needles. In 2015, Scott County, Ind., sought to combat an HIV outbreak fueled by injected opioid use that infected 215 people. Drug use has also been connected to multiple HIV clusters in Massachusetts and Kentucky.

HHS reported that injection drug users accounted for 1 in 10 new HIV cases in 2016.

Expanding syringe exchange programs across the country could minimize this problem, experts said.

“Unfortunately, in the United States we haven’t done as good a job as other Western countries in making sure that those programs are widely available for those Americans who need them,” said Millett.

The CDC and HHS consider syringe exchange programs effective interventions, but some cities, such as Charleston, W.Va., that implemented the programs have now shut them down because of neighborhood complaints, funding concerns and opposition from citizens who object to providing injection equipment.

Federal funds can be used to support this intervention, but these dollars cannot go directly toward purchasing needles.