For those who make too much money to qualify for health insurance subsidies on the individual market, there may be no Goldilocks moment when shopping for a plan. No choice is just right.
A policy with an affordable premium may come with a deductible that's too high. If the copayments for physician visits are reasonable, the plan may not include their preferred doctors.
These consumers need better options, and in early August federal officials offered a strategy to help bring down costs for them.
The guidance is from the Centers for Medicare & Medicaid Services, which oversees the insurance marketplaces set up by the Affordable Care Act. CMS is encouraging states to allow the sale of plans outside of those exchanges that don't incorporate a surcharge insurers started tacking on last year.
Many insurers added the premium surcharges last fall to plans sold on the individual market. It was a response to the Trump administration's announcement that it would no longer pay the companies for the "cost-sharing reduction" subsidies required under the health law. The subsidies help cover deductibles and other out-of-pocket costs for lower-income consumers who buy marketplace plans.
Insurers typically added the cost to silver-level plans because those are the type of plans that consumers have to buy in order to receive the cost-sharing subsidies. "Silver loading," as it's called, added an estimated 10 percent to the cost of those plans, according to the Congressional Budget Office.
People who qualified for federal premium subsidies — those with incomes up to 400 percent of the federal poverty level (about $48,000 for one person or $100,000 for a family of four) — were shielded from the surcharge because their subsidies increased to cover the cost.
But people with higher incomes faced higher premiums. The new guidance is geared to help them.
"It encourages states to encourage silver loading only on the exchange," said Aviva Aron-Dine, vice president for health policy at the Center on Budget and Policy Priorities.
But some analysts say they're unsure if the new federal policy will make a difference since states have already implemented similar strategies.
Many states moved last fall to limit silver loading to plans sold on the exchanges, while allowing or, in the case of California, requiring, very similar plans to be sold off the exchanges without the extra premium charge.
Yet CMS' endorsement of the strategy removes doubts states may have had, said David Anderson, a research associate at Duke University's Margolis Center for Health Policy who has tracked the issue.
Eighty-three percent of people who bought a plan during the open-enrollment period for 2018 qualified for premium tax credits. The average monthly premium per subsidized enrollee was $639; after accounting for premium tax credits, however, enrollees owed just $89 on average. That amount was 16 percent lower than the monthly premium the year before.
For people who don't qualify for premium tax credits, the picture is very different. The average monthly premium for 2018 was $522. That total was 28 percent higher than the previous year's total of $407, according to an analysis by the Center on Budget and Policy Priorities of CMS enrollment data.
In general, federal rules require that insurers charge the same rates for identical qualified health plans that are sold on and off the exchanges. The CMS guidance suggests that the unloaded plans could be tweaked slightly in terms of cost sharing or other variables so that they are not identical to those on the marketplaces.
Tracing what type of coverage is purchased off the exchange is difficult because there is no centralized source. Consumers can buy plans directly from insurers, or they may use a broker or an online web portal. According to one such portal, eHealth, 28 percent of unsubsidized consumers on its site bought silver plans in 2018, while 42 percent bought bronze plans, whose coverage is less generous than silver plans and typically have lower premiums. Conversely, on the exchanges nearly two-thirds of people bought silver plans in 2018 while 29 percent bought bronze plans, according to federal data.
If fewer insurers add the CSR load to silver plans sold off the exchange, those plans may be more affordable next year than they were in 2018, said Cynthia Cox, director of health reform and private insurance at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)
"This makes silver plans an option for [unsubsidized] people who wanted to buy a silver plan but might have been pushed off onto a bronze plan," she said.
Consumers who want to consider off-exchange plans have to find them first. Some experts suggest checking with insurers that are selling on the marketplace in an area, because it's possible that they'll also be selling plans off the exchange.
But that's not a given. A health insurance broker can help people find and evaluate plans sold off the exchange. But experts urge consumers to stay on their toes and make sure they understand whether the plans they're considering provide comprehensive coverage.
Starting in October, insurers can offer short-term plans with limited benefits that last up to a year.
"Differentiating between the two may not be easy, and the off-exchange unsubsidized market is the target market for short-term plans," said Anderson.
The proposed rule comes on the heels of June's landmark Supreme Court ruling, in which a 5-4 majority held that public-sector workers don't have to pay unions for the cost of collective bargaining, calling it a violation of their free speech.
Medicaid home care aides — hourly workers who help the elderly and disabled with daily tasks like eating, getting dressed and bathing — are emerging as the latest target in the ongoing power struggle between conservatives and organized labor.
About half a million of these workers belong to the Service Employees International Union, a public-sector union that represents almost 1.9 million workers in the United States and Canada. The union is an influential donor to liberal politicians and boasted strong ties to the Obama administration.
A proposed rule from the federal Centers for Medicare & Medicaid Services would prohibit home health aides paid directly by Medicaid from having their union dues automatically deducted from their paychecks, though it doesn't name the fees explicitly.
Blocking these direct Medicaid payments means the workers — especially those who don't work in a single, centralized office, or don't have a credit card or a bank account — are far less likely to pay dues, diminishing the union's potential influence.
CMS' language affects only "individual providers" — that is, those who aren't employed by the private, for-profit agencies that dominate this industry. Individual providers, who are technically state employees, are far more likely to be unionized.
The directive, which would overturn an Obama administration policy put in place to ease the collection of union dues and pay for other fees, such as health benefits, could take effect by the end of this year. A month-long comment period, ending Monday, has attracted more than 3,300 responses.
"This is just another way to make life more difficult for public-sector unions," said Jake Rosenfeld, an associate professor of sociology at Washington University in St. Louis, who studies unions and their influence.
The proposed rule comes on the heels of June's landmark Supreme Court ruling, in which a 5-4 majority held that public-sector workers don't have to pay unions for the cost of collective bargaining, calling it a violation of their free speech.
That decision expanded on the Supreme Court's 2014 ruling in Harris v. Quinn, in which the high court found that home care workers must explicitly state their desire to be in a union before the organization can collect dues. But because these workers are not attached to a single office or meeting point, organizing them into a collective unit poses a distinct challenge; collecting membership dues, even more so.
As union membership has waned in other sectors, organized labor has doubled down on home care, lobbying liberal governors to declare thousands of workers as state employees, rendering them eligible to organize and engage in collective bargaining.
The median annual salary for home health aides in 2017 was $23,100, with about 67 percent turnover in 2017. The federal Bureau for Labor Statistics projects that demand for home care will increase by as much as 41 percent from 2016 to 2026, as more Americans age.
Both SEIU and the National Employment Law Project, an advocacy group, said that, if the rule takes effect, they expect to file a lawsuit seeking to reverse the decision. And a spokesperson for California Attorney General Xavier Becerra, who has frequently clashed with the White House, said the state will "take any action necessary" to blunt its impact.
In states where home care workers are unionized, the group can have the state withhold membership fees from their paycheck and transfer them directly to the union. Workers must actively choose to join the union.
In California, where most home care workers don't work for private agencies, about 250,000 belong to the state SEIU chapter.
"They'll effectively lose their voice on the job and their ability to advocate," said Laphonza Butler, president of SEIU Local 2015, the California branch of the union.
Beyond California, home care aides have unionized in states including Connecticut, Massachusetts, Minnesota, Illinois, Oregon, Vermont and Washington.
The government is arguing that federal law does not allow states to divert Medicaid dollars to pay for a home care worker's other benefits, such as health care or job training.
"The law provides that Medicaid providers must be paid directly and cannot have part of their payments diverted to third parties outside of a few very specific exceptions," said Tim Hill, acting director for CMS' Center for Medicaid and CHIP Services, in a statement.
But it's a controversial take. Critics said CMS' argument inappropriately casts workers' paychecks as government property, instead of as their own money. And they said it leaves vulnerable workers — arguably, the backbone of elderly care — unable to fend for themselves.
"When a state pays a worker, and the worker pays the union, it's the worker's money going into the union," said Benjamin Sachs, a professor at Harvard Law School who studies labor law. "CMS doesn't have the authority to decide."
Some conservatives suggested that limiting union membership is less about home care policy and more about curtailing a powerful liberal lobbying force.
"There have been steps taken in underlying law and practice to provide extra favors to public sector unions. They are as much political bodies as they are representatives," argued Thomas Miller, a resident fellow at the conservative American Enterprise Institute.
But labor advocates warned the consequences could be steep, and not just for home care workers.
Surveys from the National Employment Law Project suggest that unionized home care workers stay in their jobs longer when represented by unions, partially because they can negotiate better pay and benefits. Higher pay also makes the job more appealing, especially as need grows.
That, many experts argued, means patients also benefit.
"We can be putting more money into making these good quality jobs. The shortages and turnover we are facing —it is not rocket science what is causing that," said Caitlin Connolly, who runs the National Employment Law Project's campaign to increase home care wages. "If we made these quality jobs, we would be able to ensure that people had access to quality care."
After her kidneys failed from the same illness that took the lives of her mother and brother, Anne Rupp went on dialysis in May 2016, spending three hours a day, three times a week undergoing the blood-cleaning procedure. She hated it.
Rupp, who had polycystic kidney disease, joined more than 95,000 other Americans on kidney transplant lists. She knew the wait could stretch out for years.
But an experimental — and controversial — source of donated organs provided a far quicker resolution: Expensive medicines to treat hepatitis C have made it possible to use organs donated by victims of opioid overdoses who were infected with the once-deadly virus.
Six months after agreeing to be in a study in which patients in need of a kidney transplant would accept infected donor organs, Rupp got a 7:30 a.m. call at her home in York, Pa. "We have a kidney for you!"
The number of people donating organs after dying from drug overdoses has risen more than 200 percent since 2012, data from the United Network for Organ Sharing (UNOS) show — more than 13 percent of donors overall. About 30 percent of the 1,382 overdose-death donors in 2017, however, tested positive for hepatitis C.
In the past, organs exposed to hep C were typically discarded or given only to patients who already had the illness. Using them in patients who don't have the virus could shorten the transplant wait time for hundreds of patients each year.
"This is super exciting because five years ago 100 percent of [the donated] hep C hearts were being buried and now some are being used," said Dr. Peter Reese, an associate professor at University of Pennsylvania. "The world has changed."
But patients who receive such organs would almost certainly need simultaneous treatment with drugs to treat hepatitis C, generally a six- to 12-week course of drugs that costs tens of thousands of dollars. And it's unknown whether long-term use of the drugs is safe and effective in this population.
"'We haven't done this before,'" Rupp, 76, remembers her doctor at Johns Hopkins Hospital in Baltimore telling her when he offered her the option. But, he explained, the new antiviral medications nearly always cure hepatitis C.
While some hep C patients have no symptoms, over time, the untreated virus can cause chronic liver disease and lead to liver failure.
The Hopkins study — and several others nationally — are opening up new medical possibilities, while exposing patients to potential costs.
Since the procedure is considered experimental, many health plans don't have a specific coverage policy on the expensive antiviral drugs that go hand in hand with it.
Insurers that responded to questions for this story generally said they take each request on a case-by-case basis, and cover the drugs if they deem them medically necessary.
Researchers and ethics experts say coverage must be clarified before the new procedure becomes more widely available.
"How can you intentionally infect someone if not 100 percent sure their third-party payer will pay for [treatment] it?" said Dr. Christine Durand, an assistant professor of medicine at Johns Hopkins University School of Medicine.
At Hopkins, patients start the antiviral drugs just before being wheeled into the operating room. Other programs wait until the patient tests positive for hepatitis C, usually in the first few days after a transplant. Generally, when part of a study, the drugs are paid for by the manufacturer or the institutions conducting the research.
When the drugs first hit the market at the end of 2013, a course of treatment cost $100,000. As more antivirals have become available, prices have fallen and coverage limits have eased for people with chronic hepatitis C. The average net price for a round of hep C antiviral therapy is now $25,167, according to SSR Health, part of SSR LLC, a boutique investment research firm.
Outside of those trials, transplant surgeons say they've sought — and often obtained — insurance coverage for the drugs. Durand said the move is cost-effective because the drugs cost less than ongoing dialysis for kidney failure or mechanical heart assist devices.
Researchers are split on whether there's enough evidence to take the procedure out of the realm of scientific study.
"It isn't the standard of care today, but it's going in that direction," said Durand.
Others advise caution until long-term results can be seen.
While the first 20 patients at Hopkins and Penn who received kidneys in a published study were all cured of hep C, "if we had 100 patients, or 200, then we would get a better sense as to whether the cure rate is 100 percent," said Penn's Reese.
The heart transplant program at Vanderbilt University Medical Center in Nashville has transplanted 42 non-infected patients with hearts exposed to hep C, and continues to follow them. Dr. Ashish Shah, the program's director, noted that some people with untreated or long-term hepatitis C have a higher incidence of coronary artery disease.
"We'll have to watch that," he said, but noted that many patients with severe heart failure would otherwise die waiting for a transplant. "It's reasonable to think that risks [of accepting an organ from a hepatitis-infected donor] are far lower."
Jay Fuentes, a 45-year-old registered nurse in Quakertown, Pa., agreed to participate in the study at Penn in hopes of getting a transplant more quickly after his kidneys failed in 2017.
"It seemed like a no-brainer to me," said Fuentes. "If I was in the first group where it had never been tried before, I might have hesitated."
He tested positive for hepatitis C shortly after the surgery and took the antiviral drugs for 90 days. He said he no longer tests positive and has gotten back into performing in local theater with his children.
Two HHS officials who are rolling out the plan, Dan Best and John O’Brien, described their efforts to Kaiser Health News not as a public relations strategy but a push to reform the system.
Three months after President Donald Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric.
Many details have yet to be announced. But experts who pay close attention to federal drug policy and Medicare rules say the administration is preparing to incrementally roll out a multipronged plan that tasks the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration with promoting competition, attacking the complicated drug rebate system and introducing tactics to lower what the government pays for drugs.
Mark McClellan, director of the Duke-Margolis Center for Health Policy in Durham, N.C., and a former CMS administrator, said that although none of the initial steps has "fundamentally transformed drug prices," there is "a lot going on inside the administration."
Two HHS officials who are rolling out the plan, Dan Best and John O'Brien, described their efforts to Kaiser Health News not as a public relations strategy but a push to reform the system.
"This administration is trying to go after root causes" of high drug prices, said Wells Fargo analyst David Maris.
But others are not so optimistic.
Ameet Sarpatwari, an instructor in medicine at Harvard Medical School in Boston, said policies the administration has rolled out thus far "alone will not translate into meaningful cost savings for most Americans."
Broadly, the strategy falls under a handful of steps:
1. Attacking The Rebates
Health and Human Services Secretary Alex Azar has said Americans "do not have a real market for prescription drugs" because drug middlemen and insurers get a wide range of hidden rebates from drugmakers, but those savings may not be passed on to consumers or Medicare. In July, the administration submitted a proposed rule that could change the way rebates are handled.
Details of the proposal have not been made public. But O'Brien, a deputy assistant secretary at HHS, explained during a recent conference on federal drug spending sponsored by the Pew Charitable Trust: "You don't have to use market power to get rebates, you can use market power to obtain discounts, to actually lower the price of the drug on the front end."
Umer Raffat, an investment analyst with EverCore ISI, said "it's not clear [that drug prices are going down]" but the "rebate structure is changing."
2. Bringing More Negotiation To Medicare
This week, CMS Administrator Seema Verma announced that Medicare Advantage insurers can use a step-therapy approach to negotiate better prices for Part B drugs — those administered in hospitals and doctors' offices. These private plans will be allowed to require patients to first select the least expensive drug before stepping up to more costly drugs if the original medications aren't working.
The administration is also looking at ways to introduce more competition into Part B drug purchasing. That idea was mentioned deep inside the annual Medicare outpatient payment rule released last month.
Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes in New York, pointed to the possible introduction of a competitive purchasing program in which a firm negotiates with drugmakers to buy their drugs and then sells them to the doctors and hospitals that will administer the medications. Bach said that helps ensure that hospitals and doctors can't make more money by prescribing more expensive drugs.
Currently, Medicare pays the average sales price plus 6 percent to doctors or hospitals when they purchase drugs, a pricing mechanism that can benefit the providers if the drug costs go up. If there were a third party buying the drugs, it would "have a huge effect," Bach said.
3. Paying For Value
Trump's blueprint calls for CMS to encourage "value-based care" to lower drug prices, shifting from paying a set fee for drugs to basing payments on how well the patient does on them.
Louisiana's Medicaid program could show the way. The state is working with CMS to explore a subscription-based model to pay for hepatitis C medicines. Louisiana would pay a fixed price to a drug manufacturer that would then get unlimited access to treat patients enrolled in Louisiana's Medicaid program or in prison.
The program would move "from a big payment upfront to paying less over time based on actual outcomes," said McClellan, who also serves on the boards of health care giant Johnson & Johnson and insurer Cigna.
CMS also approved a Medicaid waiver from Oklahoma in June. Medicaid programs are allowed to negotiate drug prices. Oklahoma's plan would expand that to negotiate additional prescription price reductions based on value-based purchasing agreements.
Still, CMS' recent rejection of a related Massachusetts proposal makes it difficult to believe negotiating drug prices will really happen, said Sara Rosenbaum, a professor of health law and policy at George Washington University.
That proposal would have allowed Massachusetts' Medicaid program to choose drugs based on cost and how well the medicines work.
"They have been very good and quite careful with their [Medicaid] program and so why not let them try this?" Rosenbaum said.
4. Tackling Foreign Drug Costs
Pharmaceutical makers often sell their drugs at substantially lower prices in many foreign countries than they do in the United States. Trump emphasized in May that "it's time to end the global freeloading once and for all," saying U.S. consumers were paying part of the cost of the medicines that patients in other countries use.
He directed U.S. Trade Representative Robert Lighthizer to address the situation. Lighthizer's office declined to comment.
When Sen. Todd Young (R-Ind.) asked during a Senate health committee hearing in June whether trade agreements with other countries should be used to "level the playing field," Azar's response was swift: "We absolutely believe we should be using our trade agreements to get them to pay more even as we have our job to pay less."
Avalere Health President Matt Brow, who has been involved in talks with the administration, said it's clear the focus on overseas pricing isn't going away and the administration is "talking a lot about how to get the president what he wants."
5. Increasing Competition
FDA Commissioner Scott Gottlieb has become the Trump administration's lead proponent for increasing competition among drugmakers.
Competition resonates with Americans "because people see it every day in their experience in Costco and other places," said Rena Conti, an assistant professor at the University of Chicago.
Gottlieb has announced plans to bolster the use of generic drugs and an "action plan" to encourage the development of biosimilars, which are copycat versions of expensive biologic drugs made from living organisms.
And to combat anti-competitive behavior in the market, Gottlieb said the FDA has passed along information to the Federal Trade Commission and hinted at potential action to come: "I think we've handed them some pretty good facts."
The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10% over three months, while those who didn’t know prescribed roughly the same amount as before.
Physicians and other medical providers modestly reduced the volume of opioids they prescribed after being told one of their patients had died of an overdose, according to research published Thursday.
"You can hear a lot of statistics about the crisis," said Jason Doctor, lead author of the study, published Thursday in the journal Science. "But it always feels like it is happening elsewhere if you are not aware of any deaths in your own practice."
The research included more than 800 clinicians — doctors, nurse practitioners, physician assistants and dentists — comparing those who received a letter from the medical examiner about a patient's death and those who didn't. The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10 percent over three months, while those who didn't know prescribed roughly the same amount as before.
The study shows that awareness and education can change prescribing behavior, said Doctor, lead author and associate professor at University of Southern California's Price School of Public Policy. The modest size of the reduction among those who were notified of a death suggests "that clinicians exercised greater caution with opioids rather than abandoning use," according to the study.
The providers in the study who were informed about patients' deaths were also 7 percent less likely to start new patients on opioids.
The letter did not blame providers for the deaths but showed that authorities were paying attention, according to the study.
"We were providing them with important information and also giving them a way to make things better by changing prescribing," Doctor said. "Anyone who got the letter could continue to prescribe as much as they wanted, but we found that they didn't. They became more judicious prescribers."
Over 19,000 people died from prescription opioids in 2016, roughly double the number 14 years earlier, according to the National Institute on Drug Abuse. Most of that increase occurred from 2002 to 2011, and the numbers have been relatively stable since then, according to the NIDA.
Meanwhile, prescriptions of opioids are declining, and health officials are seeking ways to accelerate the trend.
The study did not measure whether the letters from the medical examiner or the changes in prescribing patterns had any effect on patient deaths.
Across the country, physicians have been accused of overprescribing opioids and have even faced charges related to patient overdose deaths. In an effort to better track prescribing patterns, states have started prescription drug monitoring databases.
The CDC recommends that providers avoid opioids if possible, but if they are necessary, they should start with the lowest effective dose.
Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.
Medicare pays hundreds of millions of dollars each year for prescription creams, gels and lotions made-to-order by pharmacies — mainly as pain treatments. But a new report finds that officials are concerned about possible fraud and patient safety risks from products made at nearly a quarter of the pharmacies that fill the bulk of those prescriptions.
"Although some of this billing may be legitimate, all of these pharmacies warrant further scrutiny," concludes the report from the Office of the Inspector General for the Department of Health and Human Services.
In total, 547 pharmacies — nearly 23 percent of those that submit most of the bills to Medicare for making these creams — hit one or more of five red-flag markers set by investigators. Those included what the researchers called "extremely high" prices; large percentages of Medicare members getting identical drugs — 16 of the pharmacies billed for identical drugs for 200 or more customers; "greatly increased" year-over-year billing — 20 pharmacies increased their billing by more than 10,000 percent; or having a single medical provider writing more than 131 prescriptions. More than half of those pharmacies hit two or more measures — and 10 hit all five.
One Oregon pharmacy, for example, submitted claims for 91 percent of its customers. A pharmacy in New York submitted 5,342 prescriptions ordered by one podiatrist, while a Florida pharmacy saw its Medicare billing for such treatments go from $7,468 in 2015 to $1.8 million the following year.
Many of the pharmacies are clustered in four cities: Detroit, Houston, Los Angeles and New York.
The report comes amid ongoing concern by Medicare officials about these custom-made — or compounded — drugs. In addition to questions like those raised in the report about overuse and pricing, safety has been a key issue in recent years. A meningitis outbreak in 2012 was linked to a Massachusetts pharmacy that did not maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans.
When done safely, pharmacy-made compounded drugs provide a legitimate option for patients whose medical needs can't be met by commercially available products mass-produced by pharmaceutical companies. For example, a patient who can't swallow a commercially available prescription pill might get a liquid version of a drug.
State boards of pharmacy generally oversee compounding pharmacies, and the drugs they produce are not considered approved by the Food and Drug Administration.
The new report focuses on concerns with compounded topical medications.
Medicare spending for such treatments has skyrocketed, rising more than 2,350 percent, from $13.2 million in 2010 to $323.5 million in 2016. Price hikes and an increase in the number of prescriptions written drove the increase, the report said.
It is not the first time the inspector general has looked at compounded drugs. A 2016 report found that overall spending on all types of compounded drugs — not just topical medications — rose sharply. The U.S. Postal Service inspector general and the Department of Defense also have raised concerns about rising spending and possible fraud for compounded drugs.
In response to those previous reports, the International Academy of Compounding Pharmacists, the industry's trade group, has said that legitimately compounded drugs "can dramatically improve a patient's quality of life," noting that proper billing controls need to be in place. The inspector general's report in 2016, it added, found that "such controls are not in place."
This report, which the compounding trade group has not yet reviewed, focuses on topical drugs and a subset of the 15,290 pharmacies that provide at least one such prescription each year. It looked at billing records from the 2,388 pharmacies that do at least 10 such prescriptions a year — providing 93 percent of all compounded topical drugs paid for by Medicare.
Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.
On average, those compounds were more expensive than non-compounded drugs with the same ingredients.
For example, Medicare paid an average of $751 per tube of compounded lidocaine, and $1,506 for the diclofenac, according to the inspector general's report. Non-compounded tubes of those drugs averaged $445 and $128, respectively.
FDA Commissioner Scott Gottlieb recently outlined new efforts his agency is taking to oversee compounded drugs in the wake of legislation passed by Congress following the meningitis outbreak.
"The FDA is inspecting compounding facilities to assess whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients" who could otherwise take a product sold commercially, he said in a statement issued on June 28.
Gottlieb also said the FDA plans to make more information available to patients and their doctors about compounded topical pain creams, including information about their effectiveness and any potential safety risks.
Not being effective is a safety risk, noted Miriam Anderson, a researcher with the inspector general's office who helped write the report.
The report urged the Centers for Medicare & Medicaid Services to clarify some of its policies to emphasize that insurers can limit the use of compounded drugs by requiring prior authorization or other steps. The agency concurred with the recommendations, according to the report, including the need to "follow up on pharmacies with questionable Part D billing and the prescribers associated with these pharmacies."
Anderson said the inspector general's office is continuing to probe the issue.
"We will investigate a number of leads on specific pharmacies and prescribers who were identified as having these questionable patterns," she said. "Whenever we see that kind of increase in spending, it raises concern about fraud, waste and abuse."
The battle lines are shifting as younger doctors flip their views, a change that will likely assume greater significance as the next generation of physicians takes on leadership roles.
When the American Medical Association — one of the nation's most powerful health care groups — met in Chicago this June, its medical student caucus seized an opportunity for change.
Though they had tried for years to advance a resolution calling on the organization to drop its decades-long opposition to single-payer health care, this was the first time it got a full hearing. The debate grew heated — older physicians warned their pay would decrease, calling younger advocates naïve to single-payer's consequences. But this time, by the meeting's end, the AMA's older members had agreed to at least study the possibility of changing its stance.
"We believe health care is a human right, maybe more so than past generations," said Dr. Brad Zehr, a 29-year-old pathology resident at Ohio State University, who was part of the debate. "There's a generational shift happening, where we see universal health care as a requirement."
The ins and outs of the AMA's policymaking may sound like inside baseball. But this year's youth uprising at the nexus of the medical establishment speaks to a cultural shift in the medical profession, and one with big political implications.
Amid Republican attacks on the Affordable Care Act, an increasing number of Democrats — ranging from candidates to established Congress members — are putting forth proposals that would vastly increase the government's role in running the health system. These include single-payer, Medicare-for-all or an option for anyone to buy in to the Medicare program. At least 70 House Democrats have signed on to the new "Medicare-for-all" caucus.
Organized medicine, and previous generations of doctors, had for the most part staunchly opposed to any such plan. The AMA has thwarted public health insurance proposals since the 1930s and long been considered one of the policy's most powerful opponents.
But the battle lines are shifting as younger doctors flip their views, a change that will likely assume greater significance as the next generation of physicians takes on leadership roles. The AMA did not make anyone available for comment.
Many younger physicians are "accepting of single-payer," said Dr. Christian Pean, 30, a third-year orthopedic surgery resident at New York University.
In prior generations, "intelligent, motivated, quantitative" students pursued medicine, both for the income and because of the workplace independence — running practices with minimal government interference, said Dr. Steven Schroeder, 79, a longtime medical professor at the University of California-San Francisco.
In his 50 years of teaching, students' attitudes have changed: "The 'Oh, keep government out of my work' feeling is not as strong as it was with maybe older cohorts," said Schroeder. "Students come in saying, 'We want to make a difference through social justice. That's why we're here.'"
Though "single-payer" health care was long dismissed as a left-wing pipe dream, polling suggests a slim majority of Americans now support the idea — though it is not clear people know what the term means.
A full single-payer system means everyone gets coverage from the same insurance plan, usually sponsored by the government. Medicare-for-all, a phrase that gained currency with the presidential campaign of Sen. Bernie Sanders (I-Vt.), means everyone gets Medicare, but, depending on the proposal, it may or may not allow private insurers to offer Medicare as well. (Sanders' plan, which eliminates deductibles and expands benefits, would get rid of private insurers.)
Meanwhile, lots of countries achieve universal health care — everyone is covered somehow — but the method can vary. For example, France requires all citizens purchase coverage, which is sold through nonprofits. In Germany, most people get insurance from a government-run "public option," while others purchase private plans. In England, health care is provided through the tax-funded National Health System.
American skeptics often use the phrase "socialized medicine" pejoratively to describe all of these models.
"Few really understand what you mean when you say single-payer," said Dr. Frank Opelka, the medical director of quality and health policy for the American College of Surgeons, which opposes such a policy. "What they mean is, 'I don't think the current system is working.'"
But the willingness to explore previously unthinkable ideas is evident in young doctors' ranks.
Recent surveys through LinkedIn, recruiting firm Merritt Hawkins and trade publication NEJM Catalyst indicate growing support. In the March NEJM survey, 61 percent of 607 respondents said single-payer would make it easier to deliver cost-effective, quality health care.
Delving further, that survey data shows support is stronger among younger physicians, said Dr. Namita Mohta, a hospitalist at Brigham and Women's Hospital and clinical editor at NEJM Catalyst.
But it's unclear whether these findings reflect young doctors' feelings about the policy or whether they are tapping in to broader frustrations with the American health system.
Much like the general public, doctors often use terms like single-payer, Medicare-for-all and universal health care interchangeably.
"Our younger generation is less afraid to come out and say we want universal health care," said Dr. Anna Yap, 26, an emergency medicine resident at UCLA, who served as a medical student delegate to the AMA until this past June. "But how? It's different in what forms we see."
Younger doctors also pointed to growing concern about how best to keep patients healthy. They cited research that broadly suggests having health insurance tracks with better health outcomes.
"Medical students, I would say, are very interested in public health and improving social determinants of health — one of them being access to health insurance," said Dr. Jerome Jeevarajan, 26, a neurology resident at the University of Texas-Houston, referring to non-medical factors that improve health, such as food or housing.
Some of the shift in opinion has to do with the changing realities of medical practice. Doctors now are more likely to end up working for large health systems or hospitals, rather than starting individual practices. Combined with the increasing complexity of billing private insurance, many said, that means contracting with the government may feel like less of an intrusion.
The debate is, at this point, still theoretical. Republicans — who control all branches of the federal government — sharply oppose single-payer. Meanwhile, single-state efforts in California, Colorado and New York have fallen flat.
Also, doctors represent only one part of the sprawling health care industrial complex. Other health care interests — including private insurance, the drug industry and hospital trade groups — have been slower to warm to catchphrases like single-payer or universal health care, all of which would likely mean a drop in income.
But increasingly physicians seem to be switching sides in the debate, and young physicians want to be part of the discussion.
"There's tremendous potential … to be at the table if single-payer becomes a significant part of the political discourse, and create a system that is more equitable," Pean said.
SAN JUAN, Puerto Rico — Blue tarps still dot rooftops, homes lack electricity needed to refrigerate medicines, and clinics chip away at debts incurred from running generators. Yet despite the residual effects from last year's devastating hurricanes, Puerto Rico is moving ahead with major cuts to its health care safety net that will affect more than a million of its poorest residents.
The government here needs to squeeze $840.2 million in annual savings from Medicaid by 2023, a reduction required by the U.S. territory's agreement with the federal government as the island claws its way back from fiscal oblivion.
Overall, Puerto Rico faces a crushing debt of more than $70 billion — much of it due to the territory's historically astronomical Medicaid expenses — on an island where the average household earns $20,000 and diabetes and hypertension are widespread.
But physicians, health insurers and former government officials say the drastic cuts demanded defy actuarial science and provide too little money to care for a population still traumatized by Hurricane Maria.
The cutbacks will give private health insurance companies the incentive to shuttle around patients with costly chronic diseases or mental illness, critics warn. And they do nothing to address the underlying fiscal imbalance at the root of Puerto Rico's health care woes, which stem from the fact that the federal government contributes a tiny fraction of the island's Medicaid budget, compared to what it contributes to the 50 U.S. states.
"We are rearranging the chairs on the Titanic," said Dr. Jaime Torres, whose jurisdiction included Puerto Rico when he served as a regional director of the Department of Health and Human Services.
Already health plans have been forced to lay off social workers and nurses like Eileen Calderón, who once visited dozens of chronically ill Puerto Ricans each month, finding them specialists, supervising medicine compliance and arranging rides to doctor appointments.
"These people who have been under our service for the last four or five years, all of a sudden I have to abandon them," said Dr. José Joaquín Vargas, chief medical adviser for VarMed, the Bayamon-based company that operated the program that employed Calderón.
Health Crippled By Debt
If Puerto Rico were a state, the federal government would pay 83 percent of Medicaid costs. (It pays upward of 70 percent of Medicaid expenses in 10 states, according to a formula that takes a state's economy into account.) But because of a 1968 law capping the amount of Medicaid money Washington sends to U.S. territories, the federal government pays only about 19 percent, as a fixed annual payment — a so-called block grant.
In February, Congress approved $4.8 billion in additional funds to help pay the island's Medicaid bills. But the additional payments are widely viewed as a stopgap measure; health economists say that extra money is likely to run out in September 2019, a grim estimate shared by the territory's fiscal oversight board. That's a federal control board established by Congress in 2016 to oversee Puerto Rico's budget, negotiate with its creditors and help restructure at least some of the island's debt.
Gov. Ricardo Rosselló's administration aims to reduce Medicaid spending and improve access to care by putting an end to years of regional monopolies by private health insurance companies. The insurers have locked patients into narrow networks of health care providers. Later this year, under Rosselló's plan, the companies will be forced to offer island-wide insurance plans and compete for customers.
"We do not have the luxury" of continuing to spend inefficiently, said Ángela Ávila Marrero, executive director of Puerto Rico's Health Insurance Administration.
If Rosselló's overhaul fails to achieve adequate savings — as most observers predict — drastic cuts are in the offing. Some 1.1 million Puerto Rican residents on Medicaid — out of 1.6 million enrollees — are at risk of losing coverage next fall, their health held hostage to the island's need to pay back its crippling debt.
Puerto Rico's government effectively defaulted on more than $70 billion in debt. Economists blame a decades-long recession, a corporate tax break that ended in 2006 and reckless spending by a bloated government.
But also to blame, they say, and largely unnoticed in discussions of the debt, is Puerto Rico's staggering Medicaid burden.
Poverty is so pervasive here that nearly 1 in 2 people qualify for public health insurance; Medicaid expenses in 2016 totaled $2.4 billion. Residents suffer from higher rates of chronic conditions like diabetes and asthma, and the percentage of people who are elderly is quickly rising.
Footing medical bills without the kind of federal assistance dispensed to states has effectively doomed the island's fiscal health, health economists say.
Researchers of health care say that, putting aside interest on Puerto Rico's debt, the territory's primary fiscal deficit would have been erased had Congress paid the same share of Medicaid bills that it pays the 50 states and Washington, D.C.
"The main issue is that we are not yet a state," said Rep. Jenniffer González-Colón, the commonwealth's nonvoting member of Congress. The island must pay for Medicaid, she added, "with local funds that we don't have."
Battered Even Before The Storm
Puerto Rico's health care system was already convulsing in September 2017 when Hurricane Maria struck. The federal government had issued warnings that the island would soon run out of additional Medicaid funds provided by the Affordable Care Act and 900,000 Puerto Rican residents would lose coverage.
Insurance companies, hospitals and physicians complained that the government was chronically late paying its bills. That frustration forced hospitals to defer maintenance and investments in new technology and fueled the exodus of thousands of physicians to the mainland in search of better incomes.
Today, Medicaid patients face long waits to see doctors on the island.
"If your kid needs a neurologist, for example, the waiting period is around six to 12 months," said Dr. Jorge Rosado, a pediatrician in San Juan. "For a genetics specialty, it's two to three years."
The $4.8 billion in relief funding from Congress is propping up Medicaid while the Rosselló administration negotiates new contracts with health insurance companies and enacts other measures mandated by the fiscal oversight board. Those include a new Medicaid fraud detection system and enhanced data collection.
Little Time To Waste
Barring the unlikely passage of bills that would eliminate the cap on federal Medicaid spending in Puerto Rico, the disaster relief fund is projected to run out next fall. González-Colón also authored a bill calling for statehood, which would eliminate the federal government's unequal treatment toward the island's Medicaid program.
The fiscal control board established by Congressopenly acknowledges the impending disaster. In an April 19 report, the board projects monthly costs per Medicaid patient will rise nearly40 percent over the next six years, barring any changes, and that Puerto Rico "will hit a 'Medicaid cliff.'"
Beginning this fall, Medicaid patients will be able to pick from at least four insurers, instead of being assigned to the one that had covered their ZIP code.
Puerto Rico has long capped monthly payments insurers receive for Medicaid patients regardless of how many medical services they use, a form of managed care. But the government here believes that the insurers — without their regional monopolies — will be forced to compete, offering better care and more efficient delivery. They could save money by reducing unnecessary emergency room visits or hospital stays and by negotiating discounted payment rates to providers.
The island's government has vowed to pay private insurers extra money to care for those with expensive or chronic medical conditions. Insurers have cautiously welcomed the changes.
"I support the government on what they're trying to do, but they didn't price it properly," said Dr. Richard Shinto, the president and chief executive of InnovaCare, an insurance company that sells plans in Puerto Rico.
He added, "The oversight board is fixated on cuts, but we're never going to improve health care unless more money is put into the system."
Government health officials argue Medicaid patients, especially those outside the San Juan metropolitan area, will gain access to more specialists, who are concentrated in the capital. But the island's clinics and hospitals fear they will be squeezed by insurers seeking to lower costs, just as they are still reeling from hurricane-related expenses.
Hospital General de Castañer spent $5,000 every five days for gasoline to power the generators at its three sites for seven months; Health Pro Med, a community health center, spent at least $2,000 a day in added expenses, including private flights to ferry doctors to the storm-battered island of Vieques.
Many experts are skeptical that managed-care companies will hire the army of social workers and nurses like Calderón needed to trudge up hillsides, knock on doors and do the tedious work that entails solving the daily problems of poverty. Viewed through a narrow lens, with an eye for cutting expenses, such problems can seem far outside the purview of medicine.
Many people displaced by the storm haven't yet been able to return home, and that, too, can complicate health care delivery. Carmen Ramos, executive director of Redes del Sureste, a conglomerate of 22 medical groups in Puerto Rico, says 60 percent of the letters she recently sent to patients on her mailing list were returned.
"The managed-care companies need to produce revenue," said Victoria Sale, a senior director at Camden Coalition, a pioneer of social and health programs for the chronically ill. "That's a setup for concern."
Bottom line? The economic overhaul doesn't rectify Puerto Rico's fundamental problem — it can't sustain its Medicaid program so long as Congress treats the territory differently than it treats states.
"Next year, we will go back to Congress demanding the funding we deserve as U.S. citizens," said Torres. But, he added, "it's time the local government started thinking about a Plan B."
Alarms go off so frequently in emergency rooms, doctors barely notice. And then a colleague is wheeled in on a gurney, clinging to life, and that alarm becomes a deafening wake-up call.
"It's devastating," said Dr. Kip Wenger, recalling a 33-year-old physician and friend who died by suicide in 2015. "This is a young, healthy person who has everything in the world ahead of them."
The medical profession is built on the myth that its workers are all highly conditioned athletes — clocking long hours while somehow staying immune to fatigue and the emotional toll of their jobs.
But there's a dark side to the profession that has been largely veiled — even from doctors themselves: They are far more likely than the general population to take their own lives.
Wenger said his colleague was a confident doctor who worked with him in emergency rooms all over Knoxville, Tenn., and died in one of those same ERs. Wenger is regional medical director for TeamHealth, one of the country's largest emergency room staffing companies, based in Knoxville.
One of the unavoidable dangers of being a doctor is knowing exactly how to kill yourself and having easy access to the tools to do it. There are stories of anesthesiologists found in a hospital, hooked up to an IV. Wenger said his colleague used numbing agents in order to die more painlessly.
"She wrapped herself in a blanket, and she got a Bible," Wenger said. "She wrote a note on the door to her best friend. ‘If you come here, don't come in the door. Call Kip or call Peter and they'll know what to do.' And that's how she checked out."
This young doctor had confided in a few co-workers about recent relationship struggles, but nothing that affected her work. And then she became part of the grim statistics.
"She was very strong-willed, strong-minded, an independent, young female physician," said emergency doctor Betsy Hull, a close friend. "I don't think any of us had any idea that she was struggling as much personally as she was for those several months."
Addressing An Uncomfortable Reality
An estimated 300 to 400 doctors kill themselves each year, and the suicide rate is more than double that of the general population, according to a review of 10 years of literature on the subject presented at the American Psychiatry Association annual meeting in May.
For TeamHealth, the young woman's death in 2015 sparked some deep soul-searching.
"A few of these things happened that were just so sobering," said TeamHealth co-founder Dr. Lynn Massingale. "People don't stab themselves to death. Young people don't stab themselves to death."
It's been an uncomfortable topic to address. A 2018 study from Mayo Clinic finds disenchanted doctors are more likely to make mistakes.
But TeamHealth held listening sessions and realized that burnout was rampant. To start, they began encouraging doctors to work less. Massingale said the company average is now close to 40 hours a week — though there's no avoiding nights and weekends in the ER.
The company also started a new protocol for one of the most stressful times in a physician's career: when doctors are sued. The company then pairs them with someone who has been there.
"We can't change the facts. We're not coaching you to change your memory," Massingale said. "But we can help you deal with the stress of that."
And TeamHealth is trying to reduce some bureaucratic headaches. A significant portion of the required corporate training has been deemed optional. And the company began spending millions of dollars a year to hire scribes — staff members who follow around ER physicians and enter information into sometimes finicky electronic health records.
Technology has become a real source of stress in a career that comes with lots to worry about, even beyond dealing with patients.
Dr. Jeffrey Zurosky, who is an ER director at Parkwest Medical Center in Knoxville, said he's concerned for his youngest doctors who start out with a mountain of med school debt, eager to pick up as many shifts as possible.
"I tell them: Be balanced. Don't overwork yourself. Spend time with your family. Stay married, if you can," Zurosky said.
Yet to some in the medical community, the problem is far more fundamental than "burnout." Pam Wible doesn't even like the term, since it puts the burden on physicians, as if they just have to find a way to cope. The family practitioner from Eugene, Ore., sees it all starting in medical schools. Entrenched ideals, like muscling through long hours on little sleep, are hard to break. Wible calls it abuse.
"These people who have been previously abused are now the teachers," she said. "They're teaching the next generation of doctors."
Too Close To Call For Help
And when physicians do want help, the industry makes it especially difficult. Wible said they can't go see a psychiatrist without jeopardizing their medical license.
"I know a lot of them," Wible said. "They're having to sneak out of town, pay cash and use a fake name to do it. Why are we putting these people in such a situation?"
Wible has collected more than 900 stories of doctor suicides and set up an anonymous help line. She has inspired more physicians to share their experiences, such as an emergency doctor licensed in Ohio.
"You don't focus on the 99 you save," that ER doctor said. "You end up focusing on the one that you lose."
The one he lost was 19 years old and came in with the flu, but tests didn't show anything unusual. He sent her home. She returned in cardiac arrest. When he found out she died, he went to a dark place — despite no history of depression.
"Like all doctors, you put that Superman cape on and you think you can get through it," he said.
The family filed a complaint. And being told he might lose his job pushed him over the edge. He swallowed a lethal overdose. But the police found him, and got him to a hospital where he had to be revived.
This ER doc had treated untold numbers of suicidal patients but never saw himself in their place.
"I didn't know I was at higher risk of suicide than the average person," he said.
Kaiser Health News and NPR are not naming this doctor because his story could affect his future career. But he said he wishes he could speak more freely, thinking it might encourage physicians to seek help sooner than he did.
As Purdue Pharma faced mounting criticism over deaths linked to OxyContin, rival drugmakers saw a chance to boost sales by stepping up marketing of similarly dangerous painkillers, such as fentanyl, morphine and methadone, Purdue internal documents reveal.
Purdue’s 1996-2002 marketing plans for OxyContin, which Kaiser Health News made public this year for the first time, offer an unprecedented look at how that company spent millions of dollars to push opioids for growing legions of pain sufferers. A wave of lawsuits demanding reimbursement and accountability for the opioid crisis now ravaging communities has heightened awareness about how and when drug makers realized the potential dangers of their products.
The Purdue documents lay out how the company and its biggest competitors were jockeying for market share. Some of those drugmakers’ sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.
Purdue first offered OxyContin as a remedy for moderate to severe cancer pain in 1996. Within three years, the company viewed the cancer market as too limited, with $261 million in potential annual sales versus $1.3 billion for a broader range of chronic pain care, the company’s marketing reports said.
“That was a pretty good recipe for a blockbuster,” said Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group critical of drug industry marketing.
Purdue has become the most high-profile drugmaker linked to the surging opioid crisis. But other opioid manufacturers didn’t sit by idly as sales of OxyContin skyrocketed, topping $1 billion in 2000, despite reports of overdose deaths and addiction.
Purdue’s marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone — which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.
In its 1999 marketing report, Purdue noted that Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson, was making “slow but steady” progress in promoting its Duragesic patches. The patches, which users attach to their skin, deliver a dose of fentanyl, an opioid drug about 50 to 100 times more powerful than morphine, according to the Drug Enforcement Administration.
Purdue estimated that Janssen would spend about $4 million in 1999 on medical journal advertising to persuade doctors to prescribe the patches for “early treatment of non-cancer pain and pain in the more frail elderly.” That is more than triple what Janssen spent the year before, according to the 2000 Purdue marketing report. In a statement to KHN, a Janssen spokesman said the company quit “actively marketing” Duragesic in 2008.
Purdue also spent millions on medical journal ads — and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the dangers of opioids, government records show.
In 2000, the Food and Drug Administration criticized Purdue for exaggerating the benefits of using OxyContin to treat arthritis, while in 2003 the agency found that some other ads had “grossly overstated” OxyContin’s safety.
Janssen also drew the ire of the FDA. In March 2000, the agency called some claims made for Duragesic “false or misleading,” including the suggestion that the drug “has less potential for abuse than other currently available opioids.”
In September 2004, the FDA told Janssen to “immediately cease” making “false or misleading” claims, including saying that Duragesic was “less abused than other opioid drugs.” In its statement to KHN, Janssen said its marketing actions were “appropriate and responsible,” adding that it “acted quickly to investigate and successfully resolve FDA’s inquiries.”
The Purdue marketing reports are part of a cache of documents the company provided to the Florida attorney general’s office in 2002. The Florida attorney general released them to two Florida newspapers in 2003 after Purdue lost a court battle to keep them under wraps.
More than 1,500 groups, mostly cities, counties and states, are suing Purdue Pharma, Janssen and several competitors and drug distributers in federal court in Cleveland demanding reimbursement for treatment costs and other compensation. In a statement to KHN, Purdue said: “We vigorously deny these allegations and look forward to the opportunity to present our defense.”
The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.
For its part, Purdue accused Janssen of trying to exploit public alarm over OxyContin-linked deaths to spark new sales of Duragesic.
“It has been reported that Janssen sales representatives are using improper techniques to capitalize on the negative press surrounding OxyContin Tablets and the issue of abuse and diversion,” reads the 2002 Purdue marketing plan.
In fact, opioids made by Purdue’s rivals also contributed to overdose deaths in those years and have continued to do so. In 2016, more than 42,000 people died nationwide from opioid-related causes, according to the Department of Health and Human Services.
Florida was one of the early states to see a rise in overdose deaths tied to prescription drugs. Florida medical examiner’s toxicology reports in 2002 detected oxycodone, the active ingredient in OxyContin, in hundreds of overdose fatalities. Abusers realized they could crush the pills and inject or snort the powder to get high. Many others died after mixing the pills with sedatives also prescribed by their doctors.
Florida medical examiner files also showed that abuse of fentanyl pain patches, methadone and morphine took many lives. Some abusers had figured out how to drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or otherwise ingest it.
In July 2005, the FDA warned health care professionals about abuse of fentanyl patches. In December 2007, FDA cited reports of deaths and “life-threatening adverse events” when the fentanyl patch “was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently and exposed the patch to a heat source.”
Purdue also kept an eye on methadone, noting in a 1999 marketing plan that “market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non-malignant pain due to its low cost.” But as methadone won acceptance for treating pain, it also began to kill with alarming frequency.
The FDA in November 2006 warned of deaths and dangerous side effects among patients “newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.”