The Senate's response to the opioid epidemic -- a sweeping package that contains 70 bills from Republican and Democratic lawmakers eager to be part of the solution to the nation's greatest public health crisis -- is expected to easily pass this week.
Reaction to the bill -- and a similar measure passed by the House in June -- has been mixed. The Chicago Tribune editorial board summed it up best Tuesday, writing: "The package is heartening and frustrating: heartening because it offers some positive steps, and frustrating because it doesn’t do more."
Most public health advocates and experts say that while the bill tackled some important issues, it's a relatively incremental effort. To really address an opioid crisis that, according to preliminary data released by the Centers for Disease Control and Prevention in August, killed more than 49,000 of the 72,000 overall deaths from drug overdoses in 2017, would require a considerable infusion of new funding for treatment programs and a long-term commitment from the federal government.
Daniel Raymond of the Harm Reduction Coalition said it's hard to tell a city losing its citizens to drug overdoses that help is coming in the form of a competitive grant pilot program that it may or may not receive.
"This is an election year bill to show they are doing something. That’s not always a bad thing, but I do think to some degree it's a political document," Daniel told me. "When you drill down into it, it’s not that there aren’t good ideas, but it doesn’t reach the level of, this is what our nation needs right now."
So, what's in the bill? Mainly, a lot of narrowly focused ideas. There are measures directing agencies across the federal government to create programs, expand programs and study the potential for programs.
After speaking to several experts, here's what could make an impact:
1. Stopping illegal fentanyl from entering the country
This piece of the package seems to be getting the most attention. Sponsored by Sen. Rob Portman (R-Ohio), it would take steps to stop the inflow of illegal synthetic opioids into the country, mostly from China.
While opioid deaths overall didn't increase last year, fentanyl overdoses did. New overdose estimates from the Centers for Disease Control released in August show that fentanyl overdoses have surged. Our Post colleague Christopher Ingraham reported that "there were nearly 30,000 deaths involving those drugs in 2017, according to the preliminary data, an increase of more than 9,000 over the prior year."
"A chief concern among substance abuse experts is the ubiquity of fentanyl, a synthetic opioid that’s roughly 50 times more potent than heroin. Because it’s cheap and relatively easy to make, it’s often mixed with other drugs such as heroin and cocaine," Ingraham wrote.
The bill would close loopholes in the U.S. Postal Service that allow people to sneak fentanyl into the country through the mail. The USPS currently does not know what is in packages coming in from abroad. The bill would require that foreign packages reveal their contents and where and who they're coming from.
2. Support for people in treatment and in recovery
Nearly everyone in the public-health sector agrees that access to treatment and recovery programs will be more successful than trying to stop the prescribing or trafficking of drugs. The bill does several things on this front.
It authorizes a grant program through the Substance Abuse and Mental Health Services Administration (SAMHSA) to allow organizations to develop opioid recovery centers in a community. It also requires the Department of Health and Human Services to determine best practices and then create a grant program implementing those policies or procedures, such as the use of recovery coaches, which has proven effective in Massachusetts.
It also authorizes HHS to develop grants to support people who are in recovery transition to independent living and jobs, as well as develop a pilot program to provide temporary housing for those recovering from substance abuse.
"What we know is that if treatment can continue whether its detox or medication or residential, whatever form you need, this continuation of treatment predicts that someone will stay in recovery," Deni Carise of Recovery Centers of America told me.
The bill also loosens some guidelines around medication-assisted treatment. It lifts the cap on the number of patients to whom a qualified doctor can prescribe drugs like buprenorphine, a drug proven effective at limiting opioid cravings and easing withdrawal, from 100 to 275, and expands a grant program allowing first responders to administer medication-assisted treatments. A recent study out of Stanford found that "greater access to naloxone" is one of a few things that could reduce overdose deaths.
What's not in the bill? There are two key provisions that made it into the House version, but not the Senate measure that and could be sticking points when the two chambers try to iron out the differences.
1. IMD Medicaid exclusion
The House repealed an obscure, decades-old rule known as the Institutions for Mental Diseases exclusion rule, or "IMD exclusion," prohibiting federal Medicaid reimbursements for inpatient treatment centers with more than 16 beds whose patients are mainly suffering from severe mental illness. The Health 202 wrote about the issue in June.
The Senate bill makes some changes to the IMD rule, including making sure pregnant and postpartum women in an IMD facility continue receiving Medicaid-covered services administered outside such facilities, such as prenatal care. But it doesn't allow Medicaid to pay for addiction treatment in bigger facilities.
2. Behavioral-health information sharing between health providers
The House allows doctors and other health professionals to more easily share behavioral health information, including a patient's substance abuse history.
The Senate bill, however, directs the Health and Human Services Department to examine how to appropriately disclose confidential substance-use disorder medical records. There are issues of privacy that come up around sharing mental health or substance abuse between doctors, but advocates say doctors are still bound by professional ethics and that coordinated care is a key to treatment.
An analysis by the conservative-leaning think tank American Action Forum found that two million people of prime working age were not in the work force in 2015 because of problems with prescription opioids. The loss of those workers slowed U.S. economic growth by 0.6 percent annually, according to the report by Ben Gitis, the organization’s director of labor market policy.
In states whose workforce was hit hardest by the opioid epidemic, Arkansas and West Virginia, Gitis estimates the real economic growth rate was reduced 1.7 percent annually by the absence of those workers. Prime working age is defined as 25 to 54.
Gitis said the problem is undoubtedly larger because illegal drugs such as fentanyl and heroin are exacting their own toll. But there is no way to accurately quantify the amount of those drugs used in the United States annually, he said.
Gitis said he hopes the data will encourage the business community to play a larger role in battling the drug crisis. With unemployment at its lowest in decades, employers in some sectors have complained about the difficulty of finding applicants who can pass drug tests.
Correction: An earlier version incorrectly said there was a physician cap on the drug naloxone. Thanks to reader Dr. Laura Fochtmann of Stonybrook University for alerting us to the mistake.
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AHH: A new report from the Congressional Budget Office projects a House bill that would delay or repeal parts of the Affordable Care Act would cost the government $51.6 billion over the next decade.
The CBO analysis precedes a scheduled Wednesday meeting where lawmakers will discuss the legislation, known as the Save American Workers Act, the Washington Examiner’s Kimberly Leonard reports. Here’s how some of the costs break down, per the report:
- One of the bill’s provisions would delay Obamacare’s “employer mandate” which, initially meant to take effect in 2014, required companies with 50 or more full-time employees to provide health insurance. It has been delayed several times and took effect in 2015 for companies with 100 employees. That part of the bill would suspend penalties from 2015 to 2019 and would cost $25.9 billion from 2019 to 2028, Kimberly reports.
- The bill would alter the definition of “full-time worker” from someone who works 30-hours a week up to 40-hours a week, a change that would cost $9.8 billion from 2019 to 2028.
- The bill would also delay a tax on high-cost employer-sponsored health plans to 2023, which is estimated to cost $15.5 billion.
OOF: In an interview with the Financial Times, a pharmaceutical company’s CEO defended the decision to hike the price of an antibiotic medication to more than $2,000 a bottle.
Nirmal Mulye, CEO of Nostrum Laboratories, argued there was a “moral requirement to sell the product at the highest price.” Last month, the company raised the price of nitrofurantoin, an antibiotic used to treat bladder infections, from $474.75 to $2,392, the Financial Times’s David Crow reports. “I think it is a moral requirement to make money when you can.. to sell the product for the highest price," Mulye said.
Mulye also defended Martin Shkreli, the notorious “Pharma Bro” who raised the price of an AIDS and cancer drug from $13.50 to $750 when he led Turing Pharmaceuticals. “I agree with Martin Shkreli that when he raised the price of his drug he was within his rights because he had to reward his shareholders,” Mulye said. “If he’s the only one selling it then he can make as much money as he can… This is a capitalist economy and if you can’t make money you can’t stay in business.”
“Companies such as Nostrum and Casper have been able to raise the price of the antibiotic so dramatically due to supply shortages of the liquid version that were prompted by new rules on impurities from the US Food and Drug Administration,” David writes. “Several suppliers, including Nostrum, removed their versions of the drug from the market to reformulate them to comply with the FDA regulations. The medicine now appears on a list of drug shortages that is maintained by the American Society of Health-System Pharmacists, although it is not on the FDA’s list of shortages.”
FDA Commissioner Scott Gottlieb responded to the FT report in a tweet yesterday:
1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine— Scott Gottlieb, M.D. (@SGottliebFDA) September 11, 2018
2/2 There are other suppliers of this product and, by its own admission in @FT, the company in question isn’t actively marketing their formulation. Their excessive price, detached from market principles, exists only on a list and should remain there in a competitive marketplace— Scott Gottlieb, M.D. (@SGottliebFDA) September 11, 2018
According to #FDA’s shortages database; the drug in question — which is a liquid formulation of a widely available, and old and less frequently used antibiotic — is also NOT in shortage.— Scott Gottlieb, M.D. (@SGottliebFDA) September 11, 2018
OUCH: In the year since Hurricane Maria, the Federal Emergency Management Agency has approved just 75 of the 2,000 applications from Puerto Ricans for funeral assistance. That’s just 3 percent of the applications, according to a letter FEMA director William “Brock” Long sent to Sen. Elizabeth Warren (D-Mass.), BuzzFeed News’s Nidhi Prakash reports.
“FEMA's funeral assistance is intended to help people who have lost loved ones in disaster situations pay for funeral costs, including caskets, mortuary services, burial plots, and cremations,” Nidhi reports. “Although Long did not give a specific reason in his letter for the rejections, he pointed to FEMA’s requirements for funeral assistance. To qualify, Puerto Ricans had to provide a death certificate or letter from a government official ‘that clearly indicates the death was attributed to the emergency or disaster, either directly or indirectly." Long wrote the letter on behalf of FEMA and the Department of Health and Human Services.
Nidhi writes acquiring the needed information was “impossible” for many families, “as the Puerto Rican government recently admitted, officials were not counting hurricane-related deaths correctly.” “Even now, families whose loved ones died because of the hurricane but weren’t initially counted still won’t have updated death certificates or letters from the government to send to FEMA, because the updated death toll is just an estimate,” she writes. Neither FEMA nor HHS responded to BuzzFeed News’s request for comment.
— Yesterday, The Health 202 linked to our colleague Glenn Kessler’s Fact Checker report that follows up on a remark Supreme Court nominee Brett M. Kavanaugh made during his confirmation hearings last week. Sen. Kamala D. Harris (D-Calif.) criticized Kavanaugh in a tweet with a clip of comments he made regarding “abortion-inducing drugs,” in reference to a case brought by an antiabortion religious group challenging an Obamacare rule about providing employees contraception.
We thought it was important to come back to our colleague’s report, which gave Harris four Pinocchios for claiming Kavanaugh’s comments were a “dog whistle for going after birth control” and including a clip without his full remarks. The Health 202 also highlighted Kavanaugh’s use of the phrase, writing that Kavanaugh “appeared to refer to birth control as ‘abortion-inducing drugs.” But we did not provide the full context for the quote, which we should have included. Here’s an explanation below of Kavanaugh’s remark and context from our Post colleague:
The Facts: In 2013, Priests for Life sued HHS over Obamacare’s requirement that employers provide contraception as part of health coverage. The group argued that because the law’s opt-out provision required they fill out a form or be penalized, their exercise of religion was unfairly burdened. While a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit rejected that argument in 2014, Kavanaugh dissented.
Here's what Kavanaugh said during the hearing, when asked by Sen. Ted Cruz (R-Tex.) to explain his opinion: “That was a group that was being forced to provide a certain kind of health coverage over their religious objection to their employees, and under the Religious Freedom Restoration Act, the question was first, was this a substantial burden on the religious exercise? And it seemed to me quite clearly it was. It was a technical matter of filling out a form, in that case with -- that -- they said filling out the form would make them complicit in the provision of the abortion-inducing drugs that they were -- as a religious matter, objected to.”
The conclusion: “The issue at hand is Kavanaugh’s reference to ‘abortion-inducing drugs,’” Glenn writes. “A plain reading of his sentence, with its reference to ‘they said,’ suggests that he is merely reflecting the plaintiffs' argument…Some might argue that it’s a judgment call, open to legal interpretation, as to whether Kavanaugh ‘uncritically’ used a term that riles advocates of abortion rights. But a plain reading of Kavanaugh’s answer during the hearings shows that it is broadly consistent with his written opinion. One can question why he used the phrase ‘abortion-inducing drugs’ rather than ‘abortion-inducing products’ or ‘abortifacients.’ But it’s pretty clear from the context that he was quoting the views of the plaintiffs rather than offering a personal view.”
Being a parent and being in power shouldn’t be in conflict for a woman any more than they are for a man. pic.twitter.com/8hq8M80uDW— Zephyr Teachout (@ZephyrTeachout) September 10, 2018
— Law professor Zephyr Teachout, who is running for New York attorney general, released a campaign ad on Monday that features her getting an ultrasound.
Teachout , who says in the ad voters have “never seen an attorney general like me," is due to give birth in October.
"What does his or her future look like?” Teachout asks while the ad features an image of the black-and-white sonogram and notes of the heartbeat. “Do we save our democracy? Do we flip Congress? Does Robert Mueller indict Trump? I don't want to wait and see."
“Such was Teachout's latest contribution to a year that has seen women run for prominent office in unprecedented numbers and often do so while celebrating aspects of their lives and bodies that campaign consultants might have once urged them to cover up,” The Post’s Avi Selk writes. “Ultrasound aside, her new ad flicks at some of the qualities that have attracted supporters to her liberal, anti-Trumpian campaign.”
I've signed public health emergency declarations to help support NC and SC as they prepare for Hurricane #Florence. We stand ready to help our fellow Americans and do all we can to ensure they have access to the vital services and support they may need. https://t.co/jja8vnYJQs pic.twitter.com/I1V5J9FgWZ— Secretary Alex Azar (@SecAzar) September 11, 2018
— In anticipation of Hurricane Florence, which is barreling toward the coast of the Carolinas, HHS Secretary Alex Azar declared public health emergencies in North and South Carolina. The move will make it easier for Medicare and Medicaid beneficiaries to get access to care and health needs during the emergency. In a statement, the department also said it positioned 230 medical personnel in North Carolina and in Maryland “so these assets are available quickly to help state and local authorities respond to communities’ medical needs.” The department is coordinating with FEMA to make additional ambulances available for any necessary hospital or nursing home evacuations.
The Post’s Jason Samenow has the latest update on the status of the storm here, reporting it’s generally projected to make landfall in southeastern North Carolina on Friday as a Category 3 or 4 storm and is “likely to produce ‘catastrophic’ flooding in the eastern Carolinas, as well as destructive winds.”
— HHS announced yesterday it will expand a tent camp for migrant children outside of El Paso to more than triple its current size “to accommodate a growing number of Central American children crossing the border,” our Post colleague Nick Miroff reports.
The department said its camp at Tornillo-Guadalupe Land Port of Entry will grow from 1,200 beds to as many as 3,800. “The Trump administration established the camp in June as a temporary shelter because its facilities elsewhere were running out of space,” Nick writes, a surge that occurred at the height of Trump’s “zero tolerance” policy crackdown that led to the separation of about 2,500 migrant children from their families.
Since Trump has reversed course and stopped the separations, Nick writes HHS “has taken in greater numbers of underage migrants. The number of families illegally crossing the border jumped again in recent weeks, according to border agents and administration officials.” Spokesman for HHS’s Administration for Children and Families Kenneth Wolfe told Nick the need for additional capacity was due to a surge at the border rather than due to the administration’s separation of families. Wolfe said the agency has 12,800 minors currently in its custody, and that minors spend an average of 59 days in HHS custody, up from 51 days last year.
That's more than $26,000/month per bed. You could put the kids up at a Ritz Carlton for less. https://t.co/3SB64GN2mg— Nick Miroff (@NickMiroff) September 11, 2018
—HHS's Health Resources and Services Administration yesterday announced it awarded $21 million to 46 community health centers for participation in a research program from the National Institutes of Health. The “All of Us” program will “gather data from one million or more U.S. residents to accelerate research and improve health by taking individuals’ differences in lifestyle, environment, biology and other factors into account,” according to department news release.
Azar said the program would “lay the scientific foundation for a new era of personalized, highly effective health care.”
— Bloomberg’s Robert Langreth, David Ingold and Jackie Gu have a good explainer out about a practice by pharmacy benefit managers known as “spread pricing,” where the drug-pricing middlemen can mark up the difference between what they reimburse pharmacies for a drug and the amount they charge clients.
“In an analysis of pharmacy and middleman markups in Medicaid plans around the country, Bloomberg found big spreads on dozens of drugs, and evidence that the spreads are growing,” they write. “For many widely used generic drugs, state insurance plans are collectively paying millions of dollars in fees to private companies.”
The practice is common with generic drugs, which Robert, David and Jackie point out "often cost pennies on the dollar compared with brand-name versions, and promoting them has been the focus of U.S. efforts to keep drug costs under control—especially in insurance programs like Medicaid that provide care to millions of lower-income people."
“Yet critics argue the practice of spread pricing may actually be propping up costs as middlemen divert fees and markups to themselves, undercutting the savings generics are supposed to offer,” they write. For the 90 best-selling generics Bloomberg analyzed for their story, they found “PBMs and pharmacies siphoned off $1.3 billion of the $4.2 billion Medicaid insurers spent on the drugs in 2017.”
— And here are a few more good reads:
- The House Veterans Affairs Subcommittee on Health holds a legislative hearing on Thursday.
- The House Energy and Commerce Subcommittee on Health holds a hearing on “Examining Barriers to Expanding Innovative, Value-Based Care in Medicine” on Thursday.
- AHIP holds a webinar “Redesign your Payment Integrity Model to Achieve Savings” on Thursday.
- The National Committee on Vital and Health Statistics holds a committee meeting onThursdayand Friday.
Trump calls Puerto Rico response "an incredible unsung success":
Trump arrives in Pennsylvania to commemorate 9/11 victims: