At a time when the United States is in the grip of an opioid epidemic, many insurers are limiting access to pain medications that carry a lower risk of addiction or dependence, even as they provide comparatively easy access to generic opioid medications.
The reason, experts say: Opioid drugs are generally cheap while safer alternatives are often more expensive.
Drugmakers, pharmaceutical distributors, pharmacies and doctors have come under intense scrutiny in recent years, but the role that insurers — and the pharmacy benefit managers that run their drug plans — have played in the opioid crisis has received less attention. That may be changing, however. The New York State attorney general’s office sent letters last week to the three largest pharmacy benefit managers — CVS Caremark, Express Scripts and OptumRx — asking how they were addressing the crisis.
ProPublica and The New York Times analyzed Medicare prescription drug plans covering 35.7 million people in the second quarter of this year. Only one-third of the people covered, for example, had any access to Butrans, a painkilling skin patch that contains a less-risky opioid, buprenorphine. And every drug plan that covered lidocaine patches, which are not addictive but cost more than other generic pain drugs, required that patients get prior approval for them.
In contrast, almost every plan covered common opioids and very few required any prior approval.
The insurers have also erected more hurdles to approving addiction treatments than for the addictive substances themselves, the analysis found.
Alisa Erkes lives with stabbing pain in her abdomen that, for more than two years, was made tolerable by Butrans. But in January, her insurer, UnitedHealthcare, stopped covering the drug, which had cost the company $342 for a four-week supply. After unsuccessfully appealing the denial, Erkes and her doctor scrambled to find a replacement that would quiet her excruciating stomach pains. They eventually settled on long-acting morphine, a cheaper opioid that UnitedHealthcare covered with no questions asked. It costs her and her insurer a total of $29 for a month’s supply.
The Drug Enforcement Administration places morphine in a higher category than Butrans for risk of abuse and dependence. Addiction experts say that buprenorphine also carries a lower risk of overdose.
UnitedHealthcare, the nation’s largest health insurer, places morphine on its lowest-cost drug coverage tier with no prior permission required, while in many cases excluding Butrans. And it places Lyrica, a non-opioid, brand-name drug that treats nerve pain, on its most expensive tier, requiring patients to try other drugs first.
Erkes, who is 28 and lives in Smyrna, Georgia, is afraid of becoming addicted and has asked her husband to keep a close watch on her. “Because my Butrans was denied, I have had to jump into addictive drugs,” she said.
UnitedHealthcare said Erkes had not exhausted her appeals, including the right to ask a third party to review her case. It said in a statement, “We will work with her physician to find the best option for her current health status.”
Matthew N. Wiggin, a spokesman for UnitedHealthcare, said that the company was trying to reduce long-term use of opioids. “All opioids are addictive, which is why we work with care providers and members to promote non-opioid treatment options for people suffering from chronic pain,” he said.
Dr. Thomas R. Frieden, who led the Centers for Disease Control and Prevention under President Obama, said that insurance companies, with few exceptions, had “not done what they need to do to address” the opioid epidemic. Right now, he noted, it is easier for most patients to get opioids than treatment for addiction.
Leo Beletsky, an associate professor of law and health sciences at Northeastern University, went further, calling the insurance system “one of the major causes of the crisis” because doctors are given incentives to use less expensive treatments that provide fast relief.
The Department of Health and Human Services is studying whether insurance companies make opioids more accessible than other pain treatments. An early analysis suggests that they are placing fewer restrictions on opioids than on less addictive, non-opioid medications and non-drug treatments like physical therapy, said Christopher M. Jones, a senior policy official at the department.
Insurers say they have been addressing the issue on many fronts, including monitoring patients’ opioid prescriptions, as well as doctors’ prescribing patterns. “We have a very comprehensive approach toward identifying in advance who might be getting into trouble, and who may be on that trajectory toward becoming dependent on opioids,” said Dr. Mark Friedlander, the chief medical officer of Aetna Behavioral Health who participates on its opioid task force.
Aetna and other insurers say they have seen marked declines in monthly opioid prescriptions in the past year or so. At least two large pharmacy benefit managers announcedthis year that they would limit coverage of new prescriptions for pain pills to a seven- or 10-day supply. And bowing to public pressure — not to mention government investigations — several insurers have removed barriers that had made it difficult to get coverage for drugs that treat addiction, like Suboxone.
Experts in addiction note that the opioid epidemic has been changing and that the problem now appears to be rooted more in the illicit trade of heroin and fentanyl. But the potential for addiction to prescribed opioids is real: 20 percent of patients who receive an initial 10-day prescription for opioids will still be using the drugs after a year, according to a recent analysis by the CDC.
Several patients said in interviews that they were terrified of becoming dependent on opioid medications and were unwilling to take them, despite their pain.
In 2009, Amanda Jantzi weaned herself off opioids by switching to the more expensive Lyrica to treat the pain associated with interstitial cystitis, a chronic bladder condition.
But earlier this year, Jantzi, who is 33 and lives in Virginia, switched jobs and got a new insurer — Anthem — which said it would not cover Lyrica because there was not sufficient evidence to prove that it worked for interstitial cystitis. Jantzi’s appeal was denied. She cannot afford the roughly $520 monthly retail price of Lyrica, she said, so she takes generic gabapentin, a related, cheaper drug. She said it does not manage the pain as well as Lyrica, which she took for eight years. “It’s infuriating,” she said.
Jantzi said she wanted to avoid returning to opioids. However, “I could see other people, faced with a similar situation, saying, ‘I can’t live like this, I’m going to need to go back to painkillers,’ ” she said.
In a statement, Anthem said that its members have to meet certain requirements before it will pay for Lyrica. Members can apply for an exception, the insurer said. Jantzi said she did just that and was turned down.
With Butrans, the drug that Erkes was denied, several insurers either do not cover it, require a high out-of-pocket payment, or will pay for it only after a patient has tried other opioids and failed to get relief.
In one case, OptumRx, which is owned by UnitedHealth Group, suggested that a member taking Butrans consider switching to a “lower cost alternative,” such as OxyContin or extended-release morphine, according to a letter provided by the member.
Wiggin, the UnitedHealthcare spokesman, said the company’s rules and preferred drug list “are designed to ensure members have access to drugs they need for acute situations, such as post-surgical care or serious injury, or ongoing cancer treatment and end of life care,” as well as for long-term use after alternatives are tried.
Butrans is sold by Purdue Pharma, which has been accused offueling the opioid epidemic through its aggressive marketing of OxyContin. Butrans is meant for patients for whom other medications, like immediate-release opioids or anti-inflammatory pain drugs, have failed to work, and some scientific analyses say there is not enough evidence to show it works better than other drugs for pain.
Dr. Andrew Kolodny is a critic of widespread opioid prescribing and a co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. Kolodny said he was no fan of Butrans because he did not believe it was effective for chronic pain, but he objected to insurers suggesting that patients instead take a “cheaper, more dangerous opioid.”
“That’s stupid,” he said.
Erkes’s pain specialist, Dr. Jordan Tate, said her patient had been stable on the Butrans patch until January, when UnitedHealthcare stopped covering the product and denied Erkes’s appeal.
Without Butrans, Erkes, who once visited the doctor every two months, was now in Tate’s office much more frequently, and once went to the emergency room because she could not control her pain, thought to be related to an autoimmune disorder, Behcet’s disease.
Tate said she and Erkes reluctantly settled on extended-release morphine, a drug that UnitedHealthcare approved without any prior authorization, even though morphine is considered more addictive than the Butrans patch. She also takes hydrocodone when the pain spikes and Lyrica, which UnitedHealthcare approved after requiring a prior authorization.
Erkes acknowledged that she could have continued with further appeals, but said the process exhausted her and she eventually gave up.
While Tate said Erkes had not shown signs of abusing painkillers, her situation was far from ideal. “She’s in her 20s and she’s on extended-release morphine — it’s just not the pretty story that it was six months ago.”
Many experts who study opioid abuse say they also are concerned about insurers’ limits on addiction treatments. Some state Medicaid programs for the poor, which pay for a large share of addiction treatments, continue to require advance approval before Suboxone can be prescribed or they place time limits on its use, both of which interfere with treatment, said Lindsey Vuolo, associate director of health law and policy at the National Center on Addiction and Substance Abuse. Drugs like Suboxone, or its generic equivalent, are used to wean people off opioids but can also be misused.
The analysis by ProPublica and The Times found that restrictions remain prevalent in Medicare plans, as well. Drug plans covering 33.6 million people include Suboxone, but two-thirds require prior authorization. Even when such requirements do not exist, the out-of-pocket costs of the drugs are often unaffordable, a number of pharmacists and doctors said.
At Dr. Shawn Ryan’s addiction-treatment practice in Cincinnati, called BrightView, staff members often take patients to the pharmacy to fill their prescriptions for addiction medications and then watch them take their first dose. Research has shown that such oversight improves the odds of success. But when it takes hours to gain approval, some patients leave, said Ryan, who is also president of the Ohio Society of Addiction Medicine.
“The guy walks out, and you can’t blame him,” Ryan said. “He’s like, ‘Hey man, I’m here to get help. What’s the deal?’”
Maternity care is disappearing from America’s rural counties, and for the 28 million women of reproductive age living in those areas, pregnancy and childbirth are becoming more complicated — and more dangerous. That’s the upshot of a new report from the Rural Health Research Center at the University of Minnesota that examined obstetric services in the nation’s 1,984 rural counties over a 10-year period. In 2004, 45 percent of rural counties had no hospitals with obstetric services; by 2014, that figure had jumped to 54 percent. The decline was greatest in heavily black counties and in states with the strictest eligibility rules for Medicaid.
The decrease in services has enormous implications for women and families, says Katy B. Kozhimannil, an associate professor in health policy who directs the Minnesota center’s research efforts. Rural areas have higher rates of chronic conditions that make pregnancy more challenging, higher rates of childbirth-related hemorrhages — and higher rates of maternal and infant deaths. And because rural counties tend to be poorer, any efforts to revamp or slash Medicaid could hit rural mothers especially hard. We spoke with Kozhimannil about the new study and the implications for maternal care. (The conversation has been edited and condensed.)
You and your colleagues have been looking at maternal health issues for several years. What’s the most surprising part of this new study?
I was surprised about the findings on race. Being aware of structural racism in U.S. health care, I shouldn’t have been. But we found that hospitals are more likely to close their doors entirely or close their obstetric units in communities that have more black residents. Rural black communities also experience some of the poorest birth outcomes in the country, especially in the Southeast.
I think [the race findings] are new and really important. In all the discussions I've had around maternity care access, I think there's often a false association of “rural” with white communities and with farming, but that doesn't represent the demographic reality of rural America, which is very diverse. There are 10 million people of color in rural America, that’s about 20 percent of all rural Americans.
What has led to the decline in rural obstetric services more broadly over this 10-year period?
We didn’t choose this period because we thought it was particularly unique. We chose it because it was the most recent decade of data we could get. That said, this was a period when there was a substantial shift in the health care delivery system. The debates around Obamacare, the implementation, the threats to repeal — all that really created instability with respect to what hospitals and clinicians were expecting around payments.
And the role of finances is key. If hospitals want to offer obstetric services, they need to be ready for a baby to be born at any time — they need to have a bed available, the equipment available for mom and for baby, clinicians and staff available that have the necessary skills. That's a substantial expense. If a hospital’s revenues are limited because it has a low volume of births — as many rural hospitals do — or if revenues are unpredictable, that creates a really difficult administrative problem.
How does Medicaid play into this?
Medicaid funds about half of all births in the United States, and an even greater percentage of births in rural hospitals. Medicaid funding for births is incredibly important and it’s one factor in hospitals’ decisions around whether to keep obstetric services. We found that rural counties in states with more generous Medicaid programs — with higher income eligibility limits for pregnant women — were less likely to lose hospital-based obstetric services.
Meanwhile, there’s talk of allowing states to impose new rules that could restrict access to Medicaid.
Changes to the financing of Medicaid would likely have big negative effects on the availability of obstetric services in rural areas. Based on our study, the generosity of a state’s Medicaid program seems directly linked to access to maternity care in rural counties. As such, any new reductions or restrictions on Medicaid funding or services may affect rural hospital financing.
What is it like to be pregnant in a rural area that doesn’t have adequate maternity care? What do women do?
For some women, there may be a nearby clinic or their general practitioner may be able to see them for prenatal visits if they have a low-risk pregnancy. But then they need to give birth in a more distant area with a different set of providers.
That may not even be a choice for women who live in communities that don't have any providers that see pregnant patients, or for women that have higher risk complications that require more specialized care.
I remember talking to one woman who lived in rural northern Minnesota and who had a preterm birth with her first pregnancy. For her second pregnancy, she had to drive two hours to the nearest hospital with a high-risk obstetrician. With one child at home already, and a full-time job and a partner who worked, it was almost untenable. It would take a whole day for her to drop her child off at daycare, drive all the way to the hospital, wait for a 15-minute visit that felt rushed, then drive all the way back.
I just heard on the radio this morning that a truck ran into a railroad bridge that goes over the highway that this woman would take to go back and forth to the hospital. So if she was pregnant right now, there's a 27-mile detour on three dirt roads to get around this broken bridge. That adds probably another 45 minutes to an already two-hour drive. Things like that can happen, you know, all the time.
What about giving birth? How does living in a remote area affect the kinds of choices doctors and women make?
In a typical childbirth education class in an urban area, childbirth educators say things like, “Go to the hospital when your contractions are five minutes apart.” None of that makes any sense in a rural context where women give birth far from home.
For rural moms, a lot of the conversation in childbirth education and in prenatal care revolves around logistics and transportation: “Do you know how you’re going to get to your appointment? Do you have access to a car? Is your car reliable? Do you have money for gas? Do you have a backup plan if your car doesn't start? Do you have someone that you can call if you need to go in quickly?”
Anecdotally, I hear a lot about labor induction. The rural physicians I’ve talked to are like, “I can't believe I am trying to talk patients into having an induction.” They believe in letting labor start naturally, but given the long drive, induction is often better for patients clinically. So that if complications come up, someone’s there, monitoring your blood pressure and vital signs. It’s not, you know, your partner or friend desperately driving down dirt roads as fast as they can while you yell in the back seat.
How does all this affect outcomes for babies?
We have good information from Canada that the women who have to drive long distances to give birth have higher rates of the babies being in the neonatal intensive care unit, and even of infant mortality. And so we know that distance is associated with outcomes of care. When rural hospitals close the doors of their maternity units, women have to drive longer distances.
These seem like pretty huge hurdles for rural mothers and babies. Is there any way to address these problems to improve maternity care?
One idea is programs to support pregnant women and families, especially with respect to their housing and transportation needs when they live far away from where they're going to give birth. Alaska has actually done a tremendous job of this.
Another is for states to allow midwives and nurse practitioners to play a greater role in offering prenatal and postpartum care, without having to be under a doctor’s supervision. That would be useful. Our prior research shows that midwives, for example, attend births at about one-third of all rural hospitals, and that hospital administrators would like to expand the role midwives play.
State and federal programs to support the rural maternity workforce are crucial. There ought to be programs to support training in emergency births in rural communities that lose obstetric care, and to support the costs of providing maternity care in communities where there are willing providers.
Medicare patients in Hawaii take fewer opioid painkillers and fewer antibiotics, on average, than those in any other state. Physicians and health policy experts cite demographics as a possible reason why.
This article first appeared August 31, 2017 on ProPublica.
If you think you would be healthier if you lived in Hawaii, you may be right.
People in Hawaii appear to be much less likely to overuse problematic prescription drugs, including opioid pain medications and antibiotics, than people in the mainland United States.
Medicare beneficiaries in Hawaii used fewer opioid pain medications, fewer antibiotics, fewer antipsychotic drugs and fewer drugs labeled as risky for seniors on average than patients in any other state in 2015, according to a ProPublica analysis of data from the Centers for Medicare and Medicaid Services. Medicare’s prescription program covers more than 42 million seniors and disabled people, and pays for more than one in every four prescriptions in the U.S.
These four classes of medications are problematic for a number of reasons. Misuse and abuse of opioid painkillers has been linked to an ever-growing overdose epidemic. Overuse of antibiotics has been linked to the emergence of deadly superbugs that are resistant to drugs. Critics have faulted the use of antipsychotics in the elderly, particularly those with dementia, as a means of chemically restraining them. And the American Geriatrics Society has labeled some medications inappropriate for the elderly because they can increase the risk of falls, confusion and other problems.
Today, ProPublica is updating its Prescriber Checkup tool, which allows people to compare their doctors’ prescribing patterns in Medicare to other providers in the same specialty and state. While it has long been known that patients in the southern and southeastern United States use more medications that are prone to abuse and overuse, there’s been little discussion about why Hawaii fares so well.
“Hawaii is so different,” said Dr. Chien-Wen Tseng, a family physician and health services researcher at the University of Hawaii. “I think there is more of a cultural thing that says we don’t want to overuse medications.”
Other research also has found that people in Hawaii use fewer prescription drugs. Recent figures from the Centers for Disease Control and Prevention show that after the District of Columbia, Hawaii had the lowest rate of opioids dispensed of any state. The state also has among the lowest rates of antibiotic prescribing per capita overall, not just among its Medicare population.
Dr. Lauri Hicks, director of the CDC’s Office of Antibiotic Stewardship, said she can’t definitively explain why some states, including Hawaii, have lower rates of prescribing than others. Some of the variation could be explained by differences in the population and the health status of each state’s residents, she said in a written statement.
That said, Hicks wrote, for conditions that don’t warrant antibiotic use, such as uncomplicated bronchitis and common colds, prescribing rates tend to be highest in the South, “suggesting that there is more inappropriate antibiotic prescribing in that region than in other regions of the country.”
Hawaii doesn’t just have lower rates of prescribing for drugs that carry extra risks. Our analysis shows that among Medicare enrollees who filled at least one prescription, patients in Hawaii filled fewer overall than residents of any other state – an average of 25.7 per person in 2015, compared to 37.2 per person for the country as a whole.
Dr. Scott Miscovich, a family physician in Hawaii who heads a narcotic policy working group for the state, said that while his state has not seen the same opioid epidemic that has been striking the mainland, it is taking steps to prevent it, including rewriting laws to parallel those of other states.
“I wish I could say that I thought it was because we had this magic formula for educating our doctors or educating our public,” he said. “It really isn’t the case. ... We still have pockets of doctors that are probably significantly overprescribing all of these classes of medicine, but I think it’s a far more limited number compared to bigger areas across the United States.”
All of this is not to say that Hawaii has no health concerns. The state is struggling with a persistent methamphetamine problem, far worse than it faces with opioids, Miscovich said. And it has the highest homelessness rate of any state. (Washington, D.C., has a higher rate.) “If you roll the statistics back, it’s not all rosy,” Miscovich said.
States that come closest to matching Hawaii’s low rates of prescribing for risky and misused drugs include New Mexico, Vermont, California, Minnesota and Wyoming.
Our analysis of Medicare’s data also reveals other interesting national trends:
The number of opioid prescriptions has finally started to decline. After peaking at 81.7 million in 2014, the figure dropped to 80.2 million in 2015. The drop is even more pronounced when you consider that enrollment in Medicare’s prescription drug program continued to grow during that time.
The number of antibiotics dispensed kept going up, to 57.3 million in 2015, from 54.2 million in 2014 and 52.4 million in 2013.
The average cost per prescription continues to increase, to $94.84 in 2015 from $85.82 in 2014 and $75.73 in 2013. However, those figures do not include confidential rebates the government receives from drug manufacturers.
A nationwide survey shows that postpartum nurses often fail to warn mothers about potentially life-threatening complications, mainly because they need more education themselves.
This article first appeared August 17, 2017 on ProPublica.
by Nina Martin, ProPublica, and Renee Montagne, NPR
In recent months, mothers who nearly died in the hours and days after giving birth have repeatedly told ProPublica and NPR that their doctors and nurses were often slow to recognize the warning signs that their bodies weren't healing properly. Now, an eye-opening new study substantiates some of these concerns.
The nationwide survey of 372 postpartum nurses, published Tuesday in the MCN/American Journal of Maternal/Child Nursing, found that many of them were ill-informed about the dangers new mothers face. Needing more education themselves, they were unable to fulfill their critical role of educating moms about symptoms like painful swelling, headaches, heavy bleeding and breathing problems that could indicate potentially life-threatening complications.
By failing to alert new mothers to such risks, the peer-reviewed study found, nurses may be missing an opportunity to help reduce the maternal mortality rate in the U.S., the highest among affluent nations. An estimated 700 to 900 women die in the U.S. every year from pregnancy- and childbirth-related causes and 65,000 nearly die, according to the Centers for Disease Control. The rates are highest for black mothers and women in ruralareas. In a recent CDC Foundation analysis of data from four states, nearly 60 percent of maternal deaths were preventable.
Forty-six percent of nurses who responded to the survey were unaware that maternal mortality has risen in the U.S. in recent years, and 19 percent thought maternal deaths had actually declined. "If [nurses] aren't aware that there's been a rise in maternal mortality, then it makes it less urgent to explain to women what the warning signs are," said study co-author Debra Bingham, who heads the Institute for Perinatal Quality Improvement and teaches at the University of Maryland School of Nursing.
Only 12 percent of the respondents knew that the majority of maternal deaths occur in the days and weeks after delivery. Only 24 percent correctly identified heart-related problems as the leading cause of maternal death in the U.S. In fact, cardiovascular disease and heart failure - which, according to recent data, account for more than a quarter of maternal deaths in this country - were "the area that the nurses felt the least confident in teaching about," says Patricia Suplee, an associate professor at the Rutgers University School of Nursing in Camden, New Jersey, and the lead researcher on the study.
Nurses also said they spent very little time instructing new moms about worrisome symptoms - usually 10 minutes or less. Many of the nurses said they were only likely to discuss warning signs of such life-threatening conditions as preeclampsia (pregnancy-related high blood pressure), blood clots in the lungs, or heart problems "if relevant" - even though, as the study noted, "it is impossible to accurately predict which women will suffer from a post-birth complication."
The post-delivery education provided by nurses is particularly important because, once a mother leaves the hospital, she typically doesn't see her own doctor for another four to six weeks. Up to 40 percent of new moms - overwhelmed with caring for an infant, and often lacking in maternity leave, child care, transportation and other kinds of support - never go back for their follow-up appointments at all.
Figuring out the best way to instruct new mothers is all the more crucial, the survey noted, because the first days after giving birth are "exhausting, emotionally charged, and physiologically draining" - hardly an ideal learning environment. But like so many other important aspects of maternal health care, postpartum education has been poorly studied, Bingham said.
The respondents, of whom nearly one-third had master's or doctorate degrees, were members of the Association of Women's Health, Obstetric and Neonatal Nurses, the leading professional organization for nurses specializing in maternal and infant care. AWHONN began looking at the education issue in 2014, when Bingham was the association's vice president of nursing research and education. "We had to start really from the ground up, because we didn't know exactly what women were being taught," she said.
In focus groups conducted in New Jersey and Georgia, two states with especially high rates of maternal mortality, researchers discovered that postpartum nurses spent most of their time educating moms about how to care for their new babies, not themselves. The information mothers did receive about their own health risks was wildly inconsistent, and sometimes incorrect, Bingham said. The written materials women took home often weren't much better.
Some nurses were uncomfortable discussing the possibility that complications could be life-threatening. "We had some nurses come out and say, 'Well you know what, I don't want to scare the woman. This is supposed to be a happy time. I don't want to seem like all I want to talk about is death,'" Bingham said.
But the researchers also found that nurses could be quickly educated with short, targeted information. Using insights from the focus groups, an expert panel developed two standardized tools - a checklist and script that nurses could follow when instructing new mothers and a one-page handout of post-birth warning signs that mothers could refer to after they returned home, with clear-cut instructions for when to see a doctor or call 911. Those tools were tested in four hospitals in 2015. "Very quickly we started hearing from the nurses that women were coming back to the hospital with the handout, saying, 'I have this symptom,'" Bingham said.
One of them was a Georgia mom named Sarah Duckett, who had just given birth to her second child. A week later, she recognized the warning signs of what turned out to be a blood clot in her lung - an often fatal postpartum complication. "Those were anecdotes, but they were very powerful anecdotes," Bingham said. "I've led multiple projects over the years and rarely do I get such immediate feedback that something is working."
The shortcomings documented by the national survey could foster wider use of these tools, suggested Mary-Ann Etiebet, executive director of Merck for Mothers, which funded the study as part of a 10-year, $500 million initiative to improve maternal health around the world. "Something as simple as creating educational and training programs for nurses...can have a real impact," she said.
Reversing course, federal health officials have withdrawn a proposal that would have required private accrediting organizations to publicly release reports of problems they found in health care facilities.
This article first appeared August 03, 2017 on ProPublica.
Federal health officials have backed down from a controversial proposal that would have required private accreditors to publicly release reports about errors, mishaps and mix-ups in the nation's hospitals and health care facilities.
The Centers for Medicare and Medicaid Services had proposed in April that accreditors publicly detail problems they find during inspections of hospitals and other medical facilities, as well as the steps being taken to fix them. Nearly nine in 10 hospitals are directly overseen by these accreditors, not the government.
But in a notice released Wednesday afternoon, the government withdrew the proposal. CMS said that federal law prohibits the agency from disclosing the results of inspections performed by the accrediting organizations and that the proposal - though it required accreditors, not the agency, to release the reports - "may appear as if CMS was attempting to circumvent" the law.
"CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation," the agency said in a fact sheet. "However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care."
The government's proposal, and subsequent about face, comes as federal officials have grown increasingly concerned that private accreditors aren't picking up on serious problems at health facilities.
Health care facilities that receive federal funding are required to comply with Medicare's requirements and thus are subject to government oversight. But the law allows hospitals, ambulatory surgery centers, home health agencies and hospices to pay private, national accrediting organizations for such oversight instead.
Every year, CMS and state health agencies inspect a sample of hospitals and other health care facilities accredited by private organizations, in order to validate the work of the groups. In a report to Congress last month, CMS noted that its reviews in fiscal year 2015 found that accrediting organizations often missed serious deficiencies found soon after by state inspectors.
Leah Binder, president and CEO of The Leapfrog Group, a coalition of employers that advocates for quality and transparency in health care, criticized the CMS decision to back down.
"This is disgraceful, unfair to patients as well as employers and other purchasers of health care," she said in an email. "The public deserves full transparency on how the health care industry performs. Instead, transparency has been sacrificed to accommodate special interests that lobby to avoid disclosing embarrassing information about health care quality."
The government's proposal to make accreditors' reports public was strongly protested by accreditors and the hospitals that pay them for their services. Some questioned its legality; all challenged its wisdom. The Joint Commission, for instance, said the proposal would increase costs and decrease patient safety. "The provision will adversely affect the collaborative efforts of accrediting bodies and healthcare organizations to improve patient safety and engage in continuous quality improvement," the commission said in a June letter. "Ultimately, there will be increased patient harm and lower quality."
Another accreditor, the Center for Improvement in Healthcare Quality, raised similar concerns. "Knowing that survey [inspection] reports are public knowledge will only incentivize hospitals and other healthcare entities to go back to the days of 'hiding' quality of care issues from accreditors, rather than working with us to improve the quality and safety of care rendered to patients."
But consumer groups, business alliances and a group representing health care journalists were supportive, saying consumers deserve more information about the quality of hospitals. The Medicare Payment Advisory Commission, an independent agency that advises Congress on Medicare policy, had urged CMS to implement the requirement as soon as possible, saying it would "enable Medicare beneficiaries to make more informed decisions" about where to seek health care.
Consumer Reports and its publisher, Consumers Union, likewise supported the proposal. "Such survey [inspection] results provide insight into hospital quality that is not now transparent. …Consumers have a right to know this critical information that is used to determine if facilities are in compliance with health and safety requirements for Medicare patients, and thus, all patients."
Though accreditors have to be approved by the secretary of Health and Human Services, they rarely take punitive action against the organizations they oversee. Of the 4,010 hospitals listed on The Joint Commission's website, more than 99 percent have full accreditation and only eight are on track to lose their "gold seal of approval."
On its website, The Joint Commission allows users to check the accreditation status of hospitals but provides scant information on inspection findings, even when hospitals are described as receiving a "preliminary denial of accreditation." For one hospital, the explanation is: "Existence at time of survey of a condition, which in The Joint Commission's view, poses a threat to patients or other individuals served." The threat itself is not specified.
Other smaller accrediting organizations provide even less information.
Disclosure: Ornstein was previously president of the Association of Health Care Journalists. While he served in that position, AHCJ called for The Joint Commission to make its inspection reports public. The Joint Commission declined to do so.
Amid the public fury over the escalating costs of brand-name medications, the prices of generic drugs have been falling, raising fears about the profitability of major generic manufacturers.
This article first appeared August 08, 2017 on ProPublica.
by Charles Ornstein, ProPublica, and Katie Thomas, The New York Times
Not all drug prices are going up.
Amid the public fury over the escalating costs of brand-name medications, the prices of generic drugs have been falling, raising fears about the profitability of major generic manufacturers. Last week, Teva Pharmaceuticals reported that it had missed analysts' earnings estimates in the second quarter and planned to lay off 7,000 workers. Its share price plummeted 24 percent in one day as investors worried there was no end in sight.
Share prices of other generic drugmakers also declined, as did those of wholesalers, which profit from the sales of generic drugs and have said they expect prices to continue declining.
Mylan, another large generic drugmaker, will report its second-quarter earnings on Wednesday. Mylan also sells the EpiPen, the brand-name allergy treatment whose price increases have stoked outrage over the past year, but the company's primary business is as a seller of generic drugs.
This may seem like good news for consumers, but it's unclear how much they will save.
Why are generic prices falling?
Generic drugs are copycat versions of brand-name products and - to a point - their prices are expected to drop over time. When a brand-name drug first loses its patent protection, prices fall slowly. Over the next couple of years, as more competitors enter the market, the prices drop even more, until the pills become commodities and sell for pennies. Blockbuster drugs that have recently taken this path include Lipitor and Plavix, the cholesterol-lowering and blood-thinning pills that now cost as little as $10 for a monthly prescription.
Generic drug prices have been declining in the United States since at least 2010, according to a August 2016 report by the Government Accountability Office.
They have fallen even in the face of high-profile exceptions: Dozens of old generic drugs have risen in price in recent years, for reasons that include supply disruptions and competitors' leaving the market.
For example, the price that pharmacies paid for the antibiotic doxycycline hyclate increased to $3.65 a pill in 2013 from 5.6 cents in 2012, according to an analysis of pricing data by Adam J. Fein, president of Pembroke Consulting, who researches the drug-distribution industry. The spike in prices of doxycycline and other generic drugs led to a congressional investigation as well as state and federal inquiries into price-fixing that are still underway. A coalition of state attorneys general have accused a number of companies of colluding to keep prices high.
Fein said the price of doxycycline has since declined to 60 cents a pill. "That's a big switch," he said.
Despite these cases, the trend toward deflating generic prices appears to have accelerated as companies have more aggressively undercut each other's prices.
Making matters worse for the generics companies, they are missing out on peak profit potential because not as many brand-name products are losing patent protection. The six-month period after a drug goes generic is typically the most lucrative time for the first company to market. And the Food and Drug Administration has been clearing out a backlog of generic-drug approvals, meaning more competitors are now entering markets for certain drugs.
In a recent call with Wall Street analysts, George S. Barrett, the chairman and chief executive of Cardinal Health, a major drug distributor that reported declining profits last week, said generic deflation was not new, but that the company historically had been able to anticipate it. "It just looked a little different than we had seen," he said.
In recent years, generic companies have gone on acquisition sprees in an effort to head off some of these challenges. But they have been outmaneuvered by those who buy their products, a trend that has been intensifying. Major pharmacy chains, drug wholesalers and pharmacy benefit managers (which operate drug plans for insurers) have united into colossal buying groups. For example, Express Scripts, a large pharmacy benefit manager that runs its own mail-order pharmacy, teamed up with Walgreens Boots Alliance in May to purchase generics.
"What we're seeing is incredible competition - and we're causing it," said Dr. Steve Miller, the chief medical officer for Express Scripts.
So are consumers saving any money?
The declining prices are broadly beneficial to the health care system, and may put some slight brake on rising premiums.
But most of those with health insurance pay a fixed co-payment - $10, for example - for each generic prescription, and therefore don't pay more or less, regardless of any fluctuation in the actual price. And even those who do pay cash for generics may not notice a drop in price because many generics are already cheap.
Retail drug prices dropped 2.4 percent over the last year, based on a weighted average of 92 generics that have been on the market for at least a year, according to an analysis conducted for The New York Times and ProPublica by GoodRx, a site that tracks prices that consumers pay at the pharmacy. (Weighted averages account for how often each drug is prescribed.)
But that figure hides vast variations. The retail price for clopidogrel, the generic for Plavix, dropped 37 percent, to $3.77 from $6.03 a pill, GoodRx found. Conversely, the blood pressure drug metoprolol went up about 70 percent, to 59 cents a pill from 35 cents. But GoodRx noted that consumers can almost always do better than paying the retail price, or sometimes even their co-payments, using websites - like its own - that offer discounts.
Does this mean the problem with high drug costs has eased?
Overall drug spending is still on the rise because of the skyrocketing price of new, brand-name drugs.
For example, a report by QuintilesIMS, an industry research firm, found that in 2016, drug spending increased by nearly 5 percent, after accounting for discounts and rebates paid by manufacturers. Generic drugs accounted for 89 percent of prescriptions dispensed in 2016, but only 26 percent of the costs, according to QuintilesIMS. Each year, generic drugs make up a larger share of the prescriptions filled, while accounting for a smaller portion of drug costs, said Chester Davis Jr., the president of the Association for Accessible Medicines, the generic industry trade group.
New treatments for conditions like cancer and multiple sclerosis often enter the market with annual price tags in the tens of thousands - and sometimes hundreds of thousands - of dollars. Many manufacturers also raise the price once or twice a year, compounding the problem.
"Generic drugs are among the best-value products in health care," said Dr. Aaron S. Kesselheim, an associate professor at Harvard Medical School. But for those who must take a brand-name drugs because there is no other alternative, "they're the ones bearing the burden or the brunt of the drug price increases in recent years."
Is this trend likely to continue?
Generic manufacturers say they expect it will, and are worried that lower prices could put pressure on profits and threaten the viability of the companies. This could lead to a wave of mergers and acquisitions, reducing competition and leading to higher prices.
David Maris, an analyst for Wells Fargo, dismissed the idea that companies would go out of business. "Right now we have a very healthy generic market," he said.
The new commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, has made increased competition in the drug market a key part of his policy platform. He said he wanted to make it easier for generics manufacturers to get clearance for hard-to-copy products like eye drops, topical creams and asthma inhalers. And he wants to reduce barriers to ensure new players can enter the market for existing generic drugs, possibly lowering prices further.
"We're looking to create competition where there isn't competition," he said.
In recent months, some insurers and benefit managers have insisted that patients forgo generics and buy brand-name drugs. “It’s Alice-in-Wonderland time in the drug world,” says one physician.
This article first appeared August 06, 2017 on ProPublica.
by Charles Ornstein, ProPublica, and Katie Thomas, The New York Times
It's standard advice for consumers: If you are prescribed a medicine, always ask if there is a cheaper generic.
Nathan Taylor, a 3-D animator who lives outside Houston, has tried to do that with all his medications. But when he fills his monthly prescription for Adderall XR to treat his attention-deficit disorder, his insurance company refuses to cover the generic. Instead, he must make a co-payment of $90 a month for the brand-name version. By comparison, he pays $10 or less each month for the five generic medications he also takes.
"It just befuddles me that they would do that," said Taylor, 41.
A spokesman for his insurer, Humana, did not respond to multiple emails and phone calls requesting comment.
With each visit to the pharmacy, Taylor enters the upside-down world of prescription drugs, where conventional wisdom about how to lower drug costs is often wrong.
Consumers have grown accustomed to being told by insurers - and middlemen known as pharmacy benefit managers - that they must give up their brand-name drugs in favor of cheaper generics. But some are finding the opposite is true, as pharmaceutical companies squeeze the last profits from products that are facing cheaper generic competition.
Out of public view, corporations are cutting deals that give consumers little choice but to buy brand-name drugs - and sometimes pay more at the pharmacy counter than they would for generics.
The practice is not easy to track, and has been going on sporadically for years. But several clues suggest it is becoming more common.
In recent months, some insurers and benefit managers have insisted that patients forgo generics and buy brand-name drugs such as the cholesterol treatment Zetia, the stroke-prevention drug Aggrenox and the pain-relieving gel Voltaren, along with about a dozen others, according to memos and prescription drug claims that pharmacies shared with ProPublica and The New York Times. At the same time, consumers are sounding off on social media.
Now it appears the practice is spreading to biosimilars, the competitors for expensive, complex biologic drugs that are beginning to arrive on the market.
Consumers have become increasingly angry over what they pay for drugs, and that outrage has caught the attention of lawmakers from both parties. Democrats have identified lowering drug prices as a pillar of their economic agenda, and President Donald Trump has raised the issue repeatedly. But for now, solutions have proved elusive.
The continued success of the brand-name drug Adderall XR, long after generic competitors arrived on the market, is a case in point.
Dr. Lawrence Diller, a behavioral pediatrician in Walnut Creek, California, said he began noticing "very odd things" going on with Adderall XR and other attention-deficit drugs about two years ago. He began receiving faxes from pharmacies telling him that he had to specify that patients required brand-name versions of the drugs.
Consumers taking other medications said they had experienced the same phenomenon. Lisa Hopkins, a disabled food and nutrition supervisor in Pennsylvania, went to fill a prescription for the anti-inflammatory Voltaren gel this year.
Hopkins, 52, said her pharmacist told her that her drug plan, CVS's SilverScript, denied her claim because it was for a generic.
"I said to the lady at the insurance company, ‘That's really, really odd to me,'" Hopkins said. "She said, ‘Yes. It's happening more and more that the name brand is covered but the generic isn't.'"
Hopkins has osteoporosis and bulging spinal disks and has been on disability for almost a decade. She is covered through Medicare and receives extra help from the government for her medications, lowering her out-of-pocket costs. That means that when her drugs cost a lot, taxpayers pay the bill. By law, Medicare cannot negotiate directly with drug manufacturers and instead gets a share of any rebates collected by insurers and benefit managers, like CVS Caremark, which operate Medicare's drug plans.
In an email, a spokeswoman for CVS Caremark, Christine Cramer, said consumers never pay more in the rare instances in which the company favors a brand-name drug over a generic. "This generally occurs when there is limited or no competition among generics," she said.
Pharmacists say they are noticing the trend, too, and it takes time to understand the denied claim and pursue a remedy, including sometimes calling the doctor. While favorable treatment for a brand-name drug doesn't happen all the time, it is startling when it does, said Robert Frankil, president of Sellersville Pharmacy Inc. in Pennsylvania, which owns two pharmacies.
"There's only one reason why they're requiring you to use a more expensive product," Frankil said. "Because somewhere down the road, somebody is earning more money."
Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.
This article first appeared May 31, 2017 on ProPublica.
The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates - possibly toxic, probably worthless.
But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects.
"This was very cool," Gerona says. "Who gets the chance of analyzing drugs that have been in storage for more than 30 years?"
The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn't. Pharmacies across the country - in major medical centers and in neighborhood strip malls - routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.
Gerona and Cantrell, a pharmacist and toxicologist, knew that the term "expiration date" was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don't necessarily mean they're ineffective immediately after they "expire" - just that there's no incentive for drugmakers to study whether they could still be usable.
ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste - some of it buried in practices that the medical establishment and the rest of us take for granted. We've documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year - as much as a quarter of all the country's health care spending.
What if the system is destroying drugs that are technically "expired" but could still be safely used?
In his lab, Gerona ran tests on the decades-old drugs, including some now defunct brands such as the diet pills Obocell (once pitched to doctors with a portly figurine called "Mr. Obocell") and Bamadex. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers.
The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.
"Lo and behold," Cantrell says, "The active ingredients are pretty darn stable."
Cantrell and Gerona knew their findings had big implications. Perhaps no area of health care has provoked as much anger in recent years as prescription drugs. The news media is rife with stories of medications priced out of reach or of shortages of crucial drugs, sometimes because producing them is no longer profitable.
Tossing such drugs when they expire is doubly hard. One pharmacist at Newton-Wellesley Hospital outside Boston says the 240-bed facility is able to return some expired drugs for credit, but had to destroy about $200,000 worth last year. A commentary in the journal Mayo Clinic Proceedings cited similar losses at the nearby Tufts Medical Center. Play that out at hospitals across the country and the tab is significant: about $800 million per year. And that doesn't include the costs of expired drugs at long-term care pharmacies, retail pharmacies and in consumer medicine cabinets.
After Cantrell and Gerona published their findings in Archives of Internal Medicine in 2012, some readers accused them of being irresponsible and advising patients that it was OK to take expired drugs. Cantrell says they weren't recommending the use of expired medication, just reviewing the arbitrary way the dates are set.
"Refining our prescription drug dating process could save billions," he says.
But after a brief burst of attention, the response to their study faded. That raises an even bigger question: If some drugs remain effective well beyond the date on their labels, why hasn't there been a push to extend their expiration dates?
It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years.
In fact, the federal government has saved a fortune by doing this.
For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.
Maintaining these stockpiles is expensive. The drugs have to be kept secure and at the proper humidity and temperature so they don't degrade. Luckily, the country has rarely needed to tap into many of the drugs, but this means they often reach their expiration dates. Though the government requires pharmacies to throw away expired drugs, it doesn't always follow these instructions itself. Instead, for more than 30 years, it has pulled some medicines and tested their quality.
The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients. To determine a new drug's shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs' makeup, most "expire" after two or three years.
Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Since they are not required to check beyond it, most don't, largely because regulations make it expensive and time-consuming for manufacturers to extend expiration dates, says Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists that looks at the long-term stability of drugs. Most companies, she says, would rather sell new drugs and develop additional products.
Pharmacists and researchers say there is no economic "win" for drug companies to investigate further. They ring up more sales when medications are tossed as "expired" by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.
Industry officials say patient safety is their highest priority. Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, says expiration dates are chosen "based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient."
That being said, it's an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don't. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it.
The federal agencies that stockpile drugs - including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs - have long realized the savings in revisiting expiration dates.
In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs' expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program.
Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.
A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.
Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature.
Marc Young, a pharmacist who helped run the extension program from 2006 to 2009, says it has had a "ridiculous" return on investment. Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication, he says.
An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It's like spending a dollar to save $677.
"We didn't have any idea that some of the products would be so damn stable - so robustly stable beyond the shelf life," says Ajaz Hussain, one of the scientists who formerly helped oversee the extension program.
Hussain is now president of the National Institute for Pharmaceutical Technology and Education, an organization of 17 universities that's working to reduce the cost of pharmaceutical development. He says the high price of drugs and shortages make it time to reexamine drug expiration dates in the commercial market.
"It's a shame to throw away good drugs," Hussain says.
Some medical providers have pushed for a changed approach to drug expiration dates - with no success. In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be "considerably longer" than their expiration dates, leading to "unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients."
Citing the federal government's extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates.
No one remembers the details - just that the effort fell flat.
"Nothing happened, but we tried," says rheumatologist Roy Altman, now 80, who helped write the AMA report. "I'm glad the subject is being brought up again. I think there's considerable waste."
At Newton-Wellesley Hospital, outside Boston, pharmacist David Berkowitz yearns for something to change.
On a recent weekday, Berkowitz sorted through bins and boxes of medication in a back hallway of the hospital's pharmacy, peering at expiration dates. As the pharmacy's assistant director, he carefully manages how the facility orders and dispenses drugs to patients. Running a pharmacy is like working in a restaurant because everything is perishable, he says, "but without the free food."
Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. So at Newton-Wellesley, outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: "Do Not Dispense." The piles grow for weeks until they are hauled away by a third-party company that has them destroyed. And then the bins fill again.
"I question the expiration dates on most of these drugs," Berkowitz says.
One of the plastic boxes is piled with EpiPens - devices that automatically inject epinephrine to treat severe allergic reactions. They run almost $300 each. These are from emergency kits that are rarely used, which means they often expire. Berkowitz counts them, tossing each one with a clatter into a separate container, "… that's 45, 46, 47 …" He finishes at 50. That's almost $15,000 in wasted EpiPens alone.
In May, Cantrell and Gerona published a study that examined 40 EpiPens and EpiPen Jrs., a smaller version, that had been expired for between one and 50 months. The devices had been donated by consumers, which meant they could have been stored in conditions that would cause them to break down, like a car's glove box or a steamy bathroom. The EpiPens also contain liquid medicine, which tends to be less stable than solid medications.
Testing showed 24 of the 40 expired devices contained at least 90 percent of their stated amount of epinephrine, enough to be considered as potent as when they were made. All of them contained at least 80 percent of their labeled concentration of medication. The takeaway? Even EpiPens stored in less than ideal conditions may last longer than their labels say they do, and if there's no other option, an expired EpiPen may be better than nothing, Cantrell says.
At Newton-Wellesley, Berkowitz keeps a spreadsheet of every outdated drug he throws away. The pharmacy sends what it can back for credit, but it doesn't come close to replacing what the hospital paid.
Then there's the added angst of tossing drugs that are in short supply. Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It's being rationed because there's so little available. He holds up a purple box of atropine, which gives patients a boost when they have low heart rates. It's also in short supply. In the federal government's stockpile, the expiration dates of both drugs have been extended, but they have to be thrown away by Berkowitz and other hospital pharmacists.
The 2006 FDA study of the extension program also said it pushed back the expiration date on lots of mannitol, a diuretic, for an average of five years. Berkowitz has to toss his out. Expired naloxone? The drug reverses narcotic overdoses in an emergency and is currently in wide use in the opioid epidemic. The FDA extended its use-by date for the stockpiled drugs, but Berkowitz has to trash it.
On rare occasions, a pharmaceutical company will extend the expiration dates of its own products because of shortages. That's what happened in June, when the FDA posted extended expiration dates from Pfizer for batches of its injectable atropine, dextrose, epinephrine and sodium bicarbonate. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates.
The news sent Berkowitz running to his expired drugs to see if any could be put back into his supply. His team rescued four boxes of the syringes from destruction, including 75 atropine, 15 dextrose, 164 epinephrine and 22 sodium bicarbonate. Total value: $7,500. In a blink, "expired" drugs that were in the trash heap were put back into the pharmacy supply.
Berkowitz says he appreciated Pfizer's action, but feels it should be standard to make sure drugs that are still effective aren't thrown away.
"The question is: Should the FDA be doing more stability testing?" Berkowitz says. "Could they come up with a safe and systematic way to cut down on the drugs being wasted in hospitals?"
Four scientists who worked on the FDA extension program told ProPublica something like that could work for drugs stored in hospital pharmacies, where conditions are carefully controlled.
Greg Burel, director of the CDC's stockpile, says he worries that if drugmakers were forced to extend their expiration dates it could backfire, making it unprofitable to produce certain drugs and thereby reducing access or increasing prices.
The 2015 commentary in Mayo Clinic Proceedings, called "Extending Shelf Life Just Makes Sense," also suggested that drugmakers could be required to set a preliminary expiration date and then update it after long-term testing. An independent organization could also do testing similar to that done by the FDA extension program, or data from the extension program could be applied to properly stored medications.
ProPublica asked the FDA whether it could expand its extension program, or something like it, to hospital pharmacies, where drugs are stored in stable conditions similar to the national stockpile.
"The Agency does not have a position on the concept you have proposed," an official wrote back in an email.
Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. "The FDA will have to take the lead for a solution to emerge," he says. "We are throwing away products that are certainly stable, and we need to do something about it."
Some Medicare beneficiaries are being prescribed opioids by 10 or more doctors. Hundreds of doctors appear to be prescribing indiscriminately, says the inspector general of Health and Human Services.
This article first appeared July 13, 2017 on ProPublica.
In Washington, D.C., a Medicare beneficiary filled prescriptions for 2,330 pills of oxycodone, hydromorphone and morphine in a single month last year – written by just one of the 42 health providers who prescribed the person such drugs.
In Illinois, a different Medicare enrollee received 73 prescriptions for opioid drugs from 11 prescribers and filled them at 20 different pharmacies. He sometimes filled prescriptions at multiple pharmacies on the same day.
These are among the examples cited in a sobering new report released today by the inspector general of the U.S. Department of Health and Human Services. The IG found that heavy painkiller use and abuse remains a serious problem in Medicare's prescription drug program, known as Part D, which serves more than 43 million seniors and disabled people. Among the findings:
Of the one third of Medicare beneficiaries in Part D (or roughly 14.4 million people) who filled at least one prescription for an opioid in 2016, some 3.6 million received the painkillers for at least six months.
Consistent with data released last week by the Centers for Disease Control and Prevention, there were wide geographic differences in prescribing patterns. Alabama and Mississippi had the highest proportions of patients taking prescription painkillers - more than 45 percent each - while Hawaii and New York had the lowest - 22 percent or less.
More than half a million beneficiaries received high doses of opioids for at least three months, meaning they took the equivalent of 12 tablets a day of Vicodin 10 mg. The figure does not include patients who have cancer or those who are in hospice care, for whom such doses may be appropriate.
Almost 70,000 beneficiaries received what the inspector general labeled as extreme amounts of the drugs - an average daily consumption for the year that was more than two and a half times the level the CDC recommends avoiding. Such doses put patients at an increased risk of overdose death. Extreme prescribing could also indicate that a patient's identity has been stolen, or that the patient is diverting medications for resale.
Some 22,000 beneficiaries seem to be doctor shopping-obtaining large amounts of the drugs prescribed by four or more doctors and filled at four or more pharmacies. All states except for Missouri operate Prescription Drug Monitoring Program databases that allow doctors to check whether their patients have received drugs from other doctors before writing their own prescriptions.
More than 400 doctors, nurse practitioners and physician assistants had questionable prescribing patterns for the beneficiaries most at risk (meaning those that took extreme doses of the drugs or showed signs of doctor shopping). One Missouri prescriber wrote an average of 31 opioid prescriptions each for 112 patients on Medicare. And four doctors in the same Texas practice ordered opioids for more than 56 beneficiaries who seemed to be doctor shopping. "The patterns of these 401 prescribers are far outside the norm and warrant further scrutiny," the inspector general said.
To be sure, many seniors suffer from an array of painful conditions, and some opioids are seen as more harmful and addictive than others. Tramadol, often used to treat chronic osteoarthritis pain, was the most frequently prescribed opioid and carries a lower risk of addiction than other opioids, according to the Drug Enforcement Administration.
Moreover, last week's report from CDC shows that painkiller use is ticking downward after years of explosive growth.
Still, officials in the inspector general's office said more can and should be done to combat the problems they observed, even if the numbers are beginning to subside.
"I think what we're saying here is this is still a lot of Medicare beneficiaries," said Jodi Nudelman, regional inspector general for evaluation and inspections in the New York regional office, who supervised the report. "Regardless of if you are turning a corner, you're still at these really high levels."
The inspector general previously has called for Medicare to use its data to focus on doctors who are prescribing drugs in aberrant ways.
The inspector general's numbers differ somewhat from an April report from the Centers for Medicare and Medicaid Services, which runs Medicare. The CMS report said that 29.6 percent of Part D enrollees used opioids in 2016, down from 31.9 percent in 2011. The inspector general pegged the 2016 figure at 33 percent but did not offer any historical comparisons. It was unclear why the two agencies came up with different figures.
In a statement, CMS said opioid abuse is a priority for the Trump administration. "We are working with patients, physicians, health insurance plans, and states to improve how opioids are prescribed by health care providers and used by patients, how opioid use disorder is diagnosed and managed, and how alternative approaches to pain management could be promoted," it said.
Officials have known for years that opioid prescribing has been a problem in Medicare. ProPublica first highlighted the problem in 2013 when we published data on the drugs prescribed by every physician in the Part D program. Following that report, CMS put in place what it called an Overutilization Monitoring System, which tracked beneficiaries at the highest risk for overdoses or drug abuse. It asked the private insurance companies that run the drug program on its behalf, under contract, to review the cases and provide a response.
In a memo released in April, CMS said its monitoring system has been a success. From 2011 to 2016, it said, there was a 61 percent decrease in the number of beneficiaries who were labeled as "potential very high risk opioid overutilizers." People were flagged that way if they were taking high doses of opioids for 90 consecutive days and received prescriptions from three or more doctors at three or more pharmacies. But the agency also said it would be implementing changes in January to better target those at highest risk of abuse.
Separately, in 2014, CMS told health providers they would have to register with the Medicare program in order to prescribe medications for beneficiaries. That way, the government could screen them and take action if their prescribing habits were deemed improper. Up to that point, doctors could prescribe drugs to Medicare patients even if they weren't registered Medicare providers. Delay after delay has pushed back the requirement until 2019.
Dr. Cheryl Phillips, senior vice president for public policy and health services at LeadingAge, an association of nonprofit service providers for older adults, said managing pain in seniors is complex. Seniors are more likely to have conditions, such as orthopedic problems, cancer or degenerative joint disorders, which result in chronic pain. They sometimes don't react well to non-prescription pain relievers, such as Tylenol, aspirin or nonsteroidal anti-inflammatory medicines. Health care providers like nursing homes are still evaluated, in part, on how well they manage pain, creating an incentive to turn to drugs.
"We have to challenge the notion that being pain free is a goal," Phillips said. "It's not that I want to see people suffering, but being pain free is perhaps a myth that not only society has been seduced with but physicians have as well."
Phillips said she encourages physicians to explore nondrug alternatives, including meditation, mindfulness, moist heat and exercise.
A number of drug companies have recently entered into outcomes-based contracts. But there is scant evidence this new approach lowers costs.
This article first appeared May 31, 2017 on ProPublica.
by Charles Ornstein, ProPublica and Katie Thomas, The New York Times, July 10, 2017, 11 a.m.
This article was produced in partnership with The New York Times.
More than a decade ago, Italy tried a novel approach to help bring down drug costs: asking pharmaceutical companies to return money to the national health system if some of their medicines failed to work as expected. The effort largely flopped.
The Trump administration is now considering whether to encourage a similar approach. Pharmaceutical executives presented the idea to President Trump at a meeting in January, and the general concept was raised last month in a draft executive order aimed at combating rising drug prices.
A number of drug companies have recently entered into such deals, which they call outcomes-based contracts. Merck has done so for its diabetes drugs Januvia and Janumet, promising to return money if patients' diabetes did not meet goals for control. And Novartis, which makes the heart failure treatment Entresto, is refunding money if too many patients taking the drug are hospitalized. In more typical deals, drugmakers pay rebates to insurers based on the number of drugs sold and to gain easier access for members to their products.
But there is scant evidence this new approach lowers costs. Pharmaceutical companies still set the drug's list price and have to agree to the criteria upon which they will be measured. Some experts say such arrangements are a ploy to deflect attention from substantive changes that could hurt companies' bottom lines, such as allowing Medicare to negotiate drug prices. Moreover, the savings don't always trickle down to consumers.
"Most of them get launched with great fanfare," said Dr. Steve Miller, the chief medical officer at Express Scripts, which manages the drug benefits of more than 80 million Americans. "But then you never hear anything about it after the launch because most of them collapse under their own weight."
In a recent note to investors, David Maris, an analyst at Wells Fargo, described the approach as a "carnival game" and said he did not know of any such arrangements "where a drug company did not consider it a win for them."
Robert Zirkelbach, a spokesman for the Pharmaceutical Research and Manufacturers of America, the industry trade group, said the approach was in keeping with a trend toward paying doctors and hospitals for the quality of care they deliver rather than the number of services they provide.
"We recognize that as science is moving forward, the way we pay for medicines needs to evolve as well," Zirkelbach said. The group has been promoting the idea in an advertising campaign.
To understand how these deals work, consider the one that the drugmaker Amgen made with Harvard Pilgrim Health Care, a nonprofit insurer in Massachusetts and one of the insurers to most aggressively test the concept. It has entered into at least eight such deals over the past two years. This spring, Amgen agreed to pay a full refund to Harvard Pilgrim if patients who took its pricey new cholesterol drug, Repatha, suffered a heart attack or stroke. Repatha is intended for patients with very high cholesterol levels, for which cheaper drugs, known as statins, do not work.
As part of such deals, insurers eased restrictions on which patients could gain access to the drug, said Dr. Joshua J. Ofman, a senior vice president at Amgen. Sales of Repatha and similar drugs have disappointed in part because insurers have been reluctant to pay for them given their price. Repatha can cost up to $16,000 per year.
If Harvard Pilgrim patients taking Repatha have a heart attack or stroke, they share in the refund, getting back all out-of-pocket payments that they have made toward the drug, said Dr. Michael Sherman, chief medical officer at Harvard Pilgrim.
Doctors who prescribe Repatha said the deals do not affect how they treat patients. "We're completely agnostic to it," said Dr. Frederic S. Resnic, chairman of cardiovascular medicine at the Lahey Hospital & Medical Center in Burlington, Massachusetts, who sees patients with Harvard Pilgrim insurance. The drugs are so costly that doctors still only prescribe them when patients really need them, he said.
Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York, is skeptical. He said the pharmaceutical industry is conflating setting drug prices based on the value they bring to patients and the health care system, which he supports, with negotiating givebacks when patients don't respond to drugs, which he sees as too little, too late.
The arrangements, he said, carried "bells and whistles" that made them look good in theory. "But as long as you control all the contract terms, it can be a lot of optics but no substance," he said.
Bach and others say the pharmaceutical industry is using this approach to justify seeking major changes to federal regulations that could benefit them even more - including rolling back a requirement that Medicaid programs for the poor get the lowest drug prices, and another that bars companies from giving kickbacks to health providers. The industry says the changes are needed to allow more flexibility in the type of deals they can offer.
Drug companies and insurers touted these contracts when they were announced, but participants in several deals either declined to comment recently or provided little information about their programs.
At a conference last month in Virginia, a senior director with Prime Therapeutics, a pharmacy benefit manager, offered a blunt assessment of such contracts, saying they were not cost-effective. But in a phone interview, his boss, David Lassen, the chief clinical officer, was a bit more measured, saying that though the deals carry promise, the work to track patient outcomes is expensive and burdensome. "In their current state, where they're falling short is where you look at the return on investment," Lassen said.
Sherman at Harvard Pilgrim said the deals would not work for every drug and that drugmakers typically showed no interest when there were no competing brand-name drugs that worked in a similar way.
Some pharmaceutical executives acknowledge the model should not be seen as a panacea. Leonard S. Schleifer, the chief executive of Regeneron, questioned how such pricing would work for a drug like Dupixent, an eczema drug his company makes that was approved this year.
"Are we going to start calculating the surface area of the rash that's improved?" said Schleifer, whose company has entered into some outcomes-based deals for Praluent, a competitor to Repatha.
Other drugmakers said proof that the concept works can be seen in the interest they are getting from insurers. "No one is going to enter into these contracts if they don't believe the prices they are paying are of good value," Ofman, of Amgen, said.
Italy's experience is instructive.
Beginning in 2006, the Italian National Health System negotiated deals with drugmakers for certain medicines. It required doctors to track whether their patients were meeting certain goals, and if they were not, the pharmaceutical company would reimburse a share of what it was paid.
In 2015, researchers studying Italy's experiment concluded that the amount of money refunded by the companies was "trifling."
"The performance of this system was very, very poor," said Filippo Drago, director of the Department of Biomedical and Biotechnological Sciences at the University of Catania in Italy and an author of the study. He attributed the low savings to the administrative complexity of tracking the results and said drug companies fought efforts to reimburse for bad outcomes.
Italy now asks drug companies to provide some of their products for free - at first. Manufacturers are only paid once results are demonstrated.
"This system is working very well," Drago said.
Correction, July 10, 2017: An earlier version of this article referred incorrectly to deals between drugmakers and health plans for coverage of drugs like Repatha. The deals made it easier for patients to gain access to Repatha through their insurer; they did not ease restrictions on which patients were prescribed the drug.
