Doctors would see new mothers sooner and more frequently, and insurers would cover the increased visits, under sweeping new recommendations from the organization that sets standards of care for obstetrician-gynecologists in the U.S.
The 11-page “committee opinion” on “Optimizing Postpartum Care,” released today by the American College of Obstetricians and Gynecologists, represents a fundamental reimagining of how providers, insurers and patients can work together to improve care for women after giving birth. “To optimize the health of women and infants, postpartum care should become an ongoing process, rather than a single encounter, with services and support tailored to each woman’s individual needs,” the committee opinion states.
While an ACOG task force began rethinking its approach several years ago, the guidelines arrive at a moment of mounting concern about rising rates of pregnancy-related deaths and near-deaths in the U.S. As ProPublica and NPR have reported, more than 700 women die every year in this country from causes related to pregnancy and childbirth and more than 50,000 suffer life-threatening complications, among the worst records for maternal health in the industrialized world. The death rate for black mothers is three to four times that of white women.
The days and weeks after childbirth can be a time of particular vulnerability for new moms, with physical and emotional risks that include pain and infection, hypertension and stroke, heart problems, blood clots, anxiety and depression. More than half of maternal deaths occur after the baby is born, according to a new CDC Foundation report.
Yet for many women in the U.S., the ACOG committee opinion notes, the postpartum period is “devoid of formal or informal maternal support.” This reflects a troubling tendency in the medical system — and throughout American society — to focus on the health and safety of the fetus or baby more than that of the mother. “The baby is the candy, the mom is the wrapper,” said Alison Stuebe, who teaches in the department of obstetrics and gynecology at the University of North Carolina School of Medicine and heads the task force that drafted the guidelines. “And once the candy is out of the wrapper, the wrapper is cast aside.”
The way that providers currently care for pregnant women and infants versus new mothers exemplifies this difference. During the prenatal period, a woman may see her OB-GYN a dozen or more times, including at least two checkups during her ninth month. Her baby’s first pediatric visit usually occurs a few days after birth. But the mother may not have a follow-up appointment with her own doctor until four to six weeks after delivery — and in many cases, insurance only covers one visit. “As soon as that baby comes out, [the mom] is kind of an afterthought,” said Tamika Auguste, associate medical director of the MedStar Health Simulation Training & Education Lab in Washington, D.C., and a co-author of the ACOG opinion.
For working mothers, having to wait four to six weeks makes it harder to arrange a check-up.
Some 23 percent of mothers employed outside the home are back on the job within 10 days of giving birth, a 2014 report for the U.S. Department of Labor found; another 22 percent return to work within 40 days. Lack of childcare and transportation can also present significant hurdles to accessing care. According to ACOG, as many as 40 percent of women skip their postpartum visit; for low-income women of color, the rates are even higher.
“You may have a woman that has asthma, is having problems lactating, and is obese, and when they come to see you at six weeks, we have missed the boat here,” Auguste said.
Nor is a single visit enough time to address a new mother’s questions and concerns, especially if she had a complicated pregnancy or is suffering from chronic conditions such as hypertension, diabetes or a mood disorder. “We’re trying to address all of the issues that women are dealing with after having a baby in one 20-minute encounter,” Stuebe said. “And that’s really hard to do.”
Under the new ACOG guidelines, women would see their providers much earlier — from within three days postpartum if they have suffered from severe hypertension to no later than three weeks if their pregnancies and deliveries were normal— and would return as often as needed. Depending on a woman’s symptoms and history, the final postpartum visit could take place as late as 12 weeks after delivery and ideally would include “a full assessment of physical, social, and psychological well-being,” from pain to weight loss to sexuality to management of chronic diseases, ACOG says.
In another significant change, ACOG is urging providers to emphasize in conversations with patients the long-term health risks associated with pregnancy complications such as preterm delivery, preeclampsia and gestational diabetes. “These risk factors are emerging as an important predictor of future [cardiovascular disease],” the recommendations state. “ … [B]ut because these conditions often resolve postpartum, the increased cardiovascular disease risk is not consistently communicated to women.”
Earlier, more frequent and more individualized care could be a step toward addressing the stark racial disparities in maternal and infant health, said ACOG’s outgoing president, Haywood Brown, who has made reforming postpartum care one of the main initiatives of his term. Black mothers are at higher risk for many childbirth complications, including preeclampsia, heart failureand blood clots, and they’re more likely to suffer long-lasting health consequences. They also have higher rates of postpartum depression but are less likely to receive treatment. Regardless of race, for women whose pregnancies are covered by Medicaid, the postpartum period may be their best opportunity to get help with chronic conditions before they lose insurance coverage.
The new guidelines urge doctors to take a proactive approach, helping patients develop a postpartum care plan while still pregnant, including a team of family and friends to provide social and other support. According to ACOG, one in four new mothers surveyed recently said they didn’t even have a phone number of a health care provider to contact with concerns about themselves or their babies.
ACOG isn’t the only organization calling for a reinvention of postpartum care; patient-safety groups, researchers, nurses and midwives have also tackled the issue, recasting the three months after birth as akin to a “fourth trimester.”
“The postpartum period has become a priority,” said Debra Bingham, a professor of nursing at the University of Maryland and executive director of the Institute for Perinatal Quality Improvement who has participated in many of these initiatives.
Some providers, including Brown, who is affiliated with Duke University, are already incorporating some of ACOG’s ideas. Still, putting the reforms into common practice may take years. One of the biggest impediments is insurance reimbursement. Currently, payment for prenatal care, delivery and a single post-birth visit is bundled together into one global fee, creating a disincentive for doctors to see patients more than once, Auguste said.
The disincentives are greater for women on Medicaid, which pays for about half of U.S. births. What’s more, in many states Medicaid coverage ends at two months postpartum. The ACOG opinion didn’t estimate the cost of implementing its recommendations.
Brown agreed that revamping how postpartum care is reimbursed is critical, and insurance representatives — along with members of other medical specialties — were on the ACOG task force that drafted the new guidelines. “I want to make sure that I get some employee health plans and some health systems to adopt this nationally,” Brown said.
Indeed, although the guidelines are aimed at OB-GYNs, they would require changes throughout the maternal care system. That’s what ACOG is hoping for. “It’s really a societal call to action,” Stuebe said.
Much as the role of the addictive multibillion-dollar painkiller OxyContin in the opioid crisis has stirred controversy and rancor nationwide, so it has divided members of the wealthy and philanthropic Sackler family, some of whom own the company that makes the drug.
In recent months, as protesters have begun pressuring the Metropolitan Museum of Art in New York City and other cultural institutions to spurn donations from the Sacklers, one branch of the family has moved aggressively to distance itself from OxyContin and its manufacturer, Purdue Pharma. The widow and one daughter of Arthur Sackler, who owned a related Purdue company with his two brothers, maintain that none of his heirs have profited from sales of the drug. The daughter, Elizabeth Sackler, told The New York Times in January that Purdue Pharma’s involvement in the opioid epidemic was “morally abhorrent to me.”
Arthur died eight years before OxyContin hit the marketplace. His widow, Jillian Sackler, and Elizabeth Sackler, who is Jillian’s step-daughter, are represented by separate public relations firms and have successfully won clarifications and corrections from media outlets for suggesting that sales of the potent opioid enriched Arthur Sackler or his family.
But an obscure court document sheds a different light on family history — and on the campaign by Arthur’s relatives to preserve their image and legacy. It shows that the Purdue family of companies made a nearly $20 million payment to the estate of Arthur Sackler in 1997 — two years after OxyContin was approved, and just as the pill was becoming a big seller. As a result, though they do not profit from present-day sales, Arthur’s heirs appear to have benefited at least indirectly from OxyContin.
The 1997 payment to the estate of Arthur Sackler is disclosed in the combined, audited financial statements of Purdue and its associated companies and subsidiaries. Those documents were filed among hundreds of pages of exhibits in U.S. District Court in Abingdon, Virginia, as part of a 2007 settlement in which a company associated with Purdue and three company executives pleaded guilty to charges that OxyContin was illegally marketed. The company paid $600 million in penalties while admitting it falsely promoted OxyContin as less addictive and less likely to be abused than other pain medications.
Arthur’s heirs include his widow and grandchildren. His children, including Elizabeth, do not inherit because they are not beneficiaries of a trust that was set up as part of a settlement of his estate, according to court records. Jillian receives an income from the trust. Elizabeth’s two children are heirs and would receive bequests upon Jillian’s death. A spokesman for Elizabeth Sackler declined to comment on the Purdue payment.
Janet Wootten, a spokeswoman for Jillian Sackler, acknowledged that, as a result of a “protracted estate negotiation,” payments to Arthur Sackler’s estate “were made over many years through the mid-1990s.” She added, however, that there is no evidence that the note was paid with OxyContin profits.
“There is no differentiation in these documents of assets, profits, debts, or the like, among the various companies, let alone with regard to a specific pharmaceutical product,” she said. “In fact, nowhere do these documents identify the source of funds used to pay the note (or notes).”
Wootten said the Purdue documents “in no way substantiate any suggestion or claim that Dr. Sackler’s and/or his widow’s philanthropy has in any way been funded by OxyContin.”
The three Sackler brothers are deceased. Arthur died in 1987, Mortimer in 2010 and Raymond in 2017. The families of Mortimer and Raymond own 100 percent of privately held Purdue Pharma and form the majority of its board.
Purdue declined to answer questions about the note and the 1997 payment. The company pointed to an existing statement that says “recent news coverage has wrongly characterized the relationship” between Arthur and Purdue and that “neither he nor any of his descendants have ever had any involvement or financial stake in” the success of OxyContin.
OxyContin is one of the biggest-selling opioids in the U.S., with revenues peaking at $3.1 billion in 2010. Purdue promoted OxyContin by showering doctors with junkets and speaking engagements, according to an investigation by the U.S. General Accounting Office. Since 1999, four years after OxyContin was approved, fatal overdoses related to prescription opioids have skyrocketed fivefold to 17,087 deaths in 2016. Earlier data isn’t available, nor is it known how many of the deaths are linked to OxyContin.
The history of Purdue traces back to 1952 when the three brothers — all medical doctors — purchased the Purdue Frederick Co. in Manhattan. Arthur was both mentor and visionary. Arthur was inducted into the Medical Advertising Hall of Fame, which credited him with shaping “pharmaceutical promotion as we know it today.” He pioneered marketing directly to doctors and advertising pharmaceutical products in medical journals. One of his most successful marketing efforts was the promotion of Valium in the 1960s — an effort he directed from a company unaffiliated with Purdue Frederick.
Soon after Arthur died in 1987, his estate sold his one-third interest in the Purdue Frederick Co. to his brothers for $22.35 million, according to the 2003 book, “Pain Killer,” by New York Times journalist Barry Meier. The amount of the note carried on Purdue’s books is the same as the purchase price, indicating that the payment was not made up front. Before paying off the note, Purdue paid interest on it at a rate as high as 14 percent per year, according to the financial documents.
A portion of the note — $2.7 million — was paid to Arthur Sackler’s estate in 1994. It incurred a prepayment penalty of $300,000, likely because it was paid before the note came due in 1998. That left a balance of $19.65 million, according to Purdue records.
When Arthur’s estate settled in 1994 following a lengthy battle between his widow Jillian and his children, the agreement detailed that a note from the Purdue Frederick Company “of at least $19 million” would be included in the new trust.
In 1994, the year that the trust was established, profits of Purdue and its affiliated companies were just under $1 million, according to company documents. The next year, OxyContin was approved, and Purdue’s profits soared — to $11.5 million in 1996 and $32.8 million in 1997, the year that the note was paid off.
Purdue had other successful products before OxyContin, although none on its blockbuster scale. They included another opioid painkiller, MS Contin, as well as antiseptics and laxatives.
Wooten said the payment’s timing was not connected to OxyContin’s growing popularity. “Timing of payments had nothing to do with when funds were available,” she said, adding that it would be “absurd” to suggest that the company or Arthur’s brothers “had insufficient funds to make the estate payments following Arthur’s death in 1987.”
Long before OxyContin was introduced, the Sackler brothers already were notable philanthropists. Arthur was one of the world’s biggest art collectors and a generous benefactor to cultural and educational institutions across the world. There is the Arthur M. Sackler Gallery at the Smithsonian, the Arthur M. Sackler Museum at Harvard University, and the Jillian and Arthur M. Sackler Wing of Galleries at the Royal Academy of Arts in London.
His brothers were similarly generous. They joined with their older brother to fund the Sackler Wing at the Met, which features the Temple of Dendur exhibit. The Mortimer Sackler foundation was the principal donor of the Serpentine Sackler Gallery in London; the Sackler name is affiliated with prestigious colleges from Yale University to the University of Oxford as well as world famous cultural organizations, including the Victoria and Albert Museum in London. There is even a Sackler Rose — so christened after Mortimer Sackler’s wife purchased the naming rights in her husband’s honor.
Now the goodwill gained from this philanthropy may be waning as the Sackler family has found itself in an uncomfortable spotlight over the past six months. Two national magazines recently examined the intersection of the family’s wealth from OxyContin and its philanthropy, as have other media outlets across the world. The family has also been targeted in a campaign by photographer Nan Goldin to “hold the Sacklers accountable” for OxyContin’s role in the opioid crisis. Goldin, who says she became addicted to OxyContin after it was prescribed for surgical pain, led a protest last month at the Metropolitan Museum of Art, in which demonstrators tossed pill bottles labelled as OxyContin into the reflecting pool of its Sackler Wing.
While it doesn’t appear that any recipients of Sackler charitable contributions have returned gifts or pledged to reject future ones, pressure and scrutiny on many of those institutions is intensifying. In London, the National Portrait Gallery said it is reviewing a current pledge from the Sackler Trust.
Against that backdrop, Jillian Sackler, who was Arthur’s third wife, turned to Rubenstein Communications, which has been distributing a “fact sheet” to media reporting on the controversy.
The first item listed was that “Arthur M. Sackler, his widow and heirs, have never financially benefited from the sale of OxyContin.” It went on to say that “Prominent news media, including The New York Times, The Washington Post, TIME, Economist, CNN, the Associated Press, Agence France Press, The Guardian, Huff Post, Art News, etc., have published corrections and clarifications noting the distinction between Arthur M. Sackler and his heirs — who have had no financial interest in the sale of OxyContin — and other branches of the Sackler family.”
Public relations firm BerlinRosen in New York City represents Elizabeth Sackler, who has been openly critical of Purdue Pharma. She has said that none of her father’s descendants “benefited in any way” from the sale of OxyContin while adding: “I stand with all angry voices against abuse of power that harms or compromises any and all lives.”
Her charitable work, however, has received financial support from the side of the family that ran Purdue after her father’s death and earned profits from the sale of OxyContin. In 2011, Purdue Pharma donated $500,000 to a foundation named after Elizabeth’s uncle Mortimer, and the foundation gave the same amount to the Brooklyn Museum for the Sackler Family Curator at the Elizabeth A. Sackler Center for Feminist Art. Elizabeth Sackler is a trustee of the museum and the benefactor of the eponymous center, which is the permanent host of the Dinner Party, an installation by the artist Judy Chicago that features three large tables in the shape of a triangle. There are 39 place settings at the table for famous women, ranging from the mythical Fertile Goddess to the writer Virginia Woolf.
In 2012, the wife of the youngest Sackler brother, Raymond, contributed $5,000 to Elizabeth Sackler’s charitable foundation, which has provided substantial financial support to the feminist center at the museum. A museum spokeswoman and Elizabeth Sackler’s spokesman declined to comment about the donations.
As insurers ask consumers to pay a greater share of their drug costs, it may be cheaper to pay cash than use your insurance card. One expert estimates that consumers could be overpaying for as many as 1 in 10 prescriptions.
This article first appeared December 09, 2017 on ProPublica.
By Charles Ornstein, ProPublica, and Katie Thomas of The New York Times
Having health insurance is supposed to save you money on your prescriptions. But increasingly, consumers are finding that isn't the case.
Patrik Swanljung found this out when he went to fill a prescription for a generic cholesterol drug. In May, Swanljung handed his Medicare prescription card to the pharmacist at his local Walgreens and was told that he owed $83.94 for a three-month supply.
Alarmed at that price, Swanljung went online and found Blink Health, a start-up, offering the same drug — generic Crestor — for $45.89.
It had struck a better deal than did his insurer, UnitedHealthcare. "It's completely ridiculous," said Swanljung, 72, who lives in Anacortes, Washington.
In an era when drug prices have ignited public outrage and insurers are requiring consumers to shoulder more of the costs, people are shocked to discover they can sometimes get better deals than their own insurers. Behind the seemingly simple act of buying a bottle of pills, a host of players — drug companies, pharmacies, insurers and pharmacy benefit managers — are taking a cut of the profits, even as consumers are left to fend for themselves, critics say.
Although there are no nationwide figures to track how often consumers could have gotten a better deal on their own, one industry expert estimated that up to 10 percent of drug transactions involve such situations. If true nationwide, that figure could total as many as 400 million prescriptions a year. The system has become so complex that "there's no chance that a consumer can figure it out without help," said the expert, Michael Rea, chief executive of Rx Savings Solutions, whose company is paid by employers to help them lower workers' drug costs.
Pharmacy benefit managers, the companies that deal with drug benefits on behalf of insurers, often negotiate better prices for consumers, particularly for brand-name medications, Rea said, but that's not necessarily true for some generic drugs. Insurers' clients are frequently employers overseeing large numbers of workers, and the companies are focused on overall costs. So when insurers seek deals for generic drugs, they do so in batches, reaching agreements for groups of different drugs rather than getting the lowest price on every drug.
As a result of these complicated layers of negotiation, which are not made public, different insurers end up paying different prices for individual drugs. Further compounding confusion for consumers, some insurers require a set co-payment for each prescription — say, $15 or $20 — even when the insurer reimburses the pharmacy at a much cheaper rate.
Several companies have emerged to capitalize on consumer anger over the confusing variations in price. The players include not only Blink Health and its better-known competitor GoodRx, but also veteran businesses like the benefit manager Express Scripts, which recently helped to start a subsidiary aimed at cash-paying consumers. Amazon, the online behemoth, is also said to be considering whether to join the fray.
Last Sunday, CVS Health announced plans to merge with health insurer Aetna, a move that would create a corporate behemoth that many have said would have little incentive to serve the needs of regular people. Some consumers say their experience with CVS already demonstrates how easy it is to fall through the cracks. In one case, a customer whose plan was managed by CVS Caremark, the drug benefit manager, would have had to pay more for a drug through her plan at a CVS than what she ended up paying at the same store, with a coupon from GoodRx.
Representatives for insurers and pharmacy benefit managers say cases like Swanljung's are "outliers." "There are three to four billion generic scripts written a year, and in the vast majority of cases, they are going to get a better deal by using insurance," said Mark Merritt, chief executive of the Pharmaceutical Care Management Association, which represents benefit managers.
A spokesman for UnitedHealthcare, Swanljung's insurer, noted that while Swanljung got a lower price for generic Crestor by using Blink Health, he also takes four other prescriptions, for which he got a better deal through his insurance. (Swanljung gave UnitedHealthcare permission to discuss his situation.) Having insurance is clearly valuable, said the spokesman, Matt Burns. In addition, the co-payment for generic Crestor, also called rosuvastatin, in Swanljung's plan is set to decrease significantly in January, in large part because the price of the drug has dropped this year.
Consumers also may face penalties if they don't use their insurance and pay cash to save money. In many cases, insurers won't let them apply those purchases to a deductible or out-of-pocket spending maximum.
Still, many find that leaving their prescription card at home is worth it. Some have found a better deal even at pharmacies that are owned by their drug plan, like CVS.
Susan Thomson, 55, a university lecturer who lives in Summit, New Jersey, is covered by a high-deductible plan through her former employer. Her drug benefits are managed by CVS Caremark, a subsidiary of CVS Health. For at least a decade, she's been using a prescription lotion called sulfacetamide sodium to treat rosacea, a skin condition.
Last year, each time she filled her prescription at a CVS pharmacy, she paid $75.07. Checking the CVS Caremark website this year, she learned that the cost had gone up to $99.03 (or $81.51 if she used CVS's mail order service).
Investigating further, she found that GoodRx offered the same prescription at the same drugstore for $75.57, without her insurance. The prices were even lower at other pharmacies.
"It just doesn't seem right," she said. "I just feel that the pharmaceutical industry and health care industry are pulling these numbers out of thin air."
Michael DeAngelis, a spokesman for CVS, did not dispute the details of Thomson's experience, but said it is rare and attributed the price disparity to her high-deductible plan. Because consumers are responsible for their costs in those plans until they hit their deductible, DeAngelis said it would take them longer to reach it and they might end up spending more in the long run.
Prices can also vary widely from month to month when consumers pay cash, he said.
Drug-discount cards have been around for decades, and retailers like Walmart have also offered cheap generic drug programs, but both were mainly used by people without insurance.
That is changing. Even as more Americans have health insurance since the Affordable Care Act was passed, insurers are increasingly asking consumers to pay a larger share of their costs. In 2016, about five million people in Medicare hit a stage in which they had to pick up a greater share of their expenses.
Reporters at ProPublica and The New York Times examined whether they could get better prices on 100 of the most prescribed drugs, identified by GoodRx, without using their insurance. ProPublica's prescription claims are managed by OptumRx, a large pharmacy benefit manager owned by UnitedHealth Group; The Times's medication coverage for reporters is managed by Express Scripts.
Both reporters found lower prices on GoodRx for at least 40 drugs on the list (many were drugs that can be purchased for $4 at Walmart, without any coupon).
Blink Health also sometimes beat the insurance out-of-pocket costs, but less often than GoodRx. Blink Health recently suffered a series of setbacks when two of the largest drugstore chains, CVS and Walgreens, stopped accepting its discounts, along with a grocery chain, Publix. In November, Blink Health sued its pharmacy benefit manager, which negotiates its prices, claiming that the company, MedImpact, had violated their agreement. MedImpact has not yet formally responded to the allegations in federal court in New York.
GoodRx, a private company founded in 2010, displays the deals it has with nine pharmacy benefit managers, each offering different prices for different drugs.
"We said, let's see if we can gather all these prices and see if we can exploit the variation in these contracts," said Doug Hirsch, GoodRx's co-founder and co-chief executive, "to see if we can provide better value."
Dr. Brad Wainer, a family-practice doctor in Berwyn, Illinois, said he frequently shows patients their options on GoodRx to see if they can get a better price. "Most of them don't believe me until they go and they find it out for themselves," he said.
Consumers may also pay more if they are covered by plans that require them to pay a set co-payment, no matter the cash price. In some of those cases, the insurers require the pharmacies to send them the difference between what they collect from the consumer and what the insurers have agreed to reimburse the pharmacies.
After a New Orleans television station, WVUE, reported last year on this practice, known as a clawback, lawyers across the country filed lawsuits accusing the insurers — including Cigna, Humana and UnitedHealthcare — of overcharging consumers. The companies are contesting the suits.
Several independent pharmacists said there might be safety issues if consumers buy drugs at different pharmacies. If those prescriptions are filled without an insurance card, pharmacy systems may not catch dangerous drug interactions. "That, to me, is a recipe for disaster," said Craig Seither, who owns Fort Thomas Drug Center in Fort Thomas, Kentucky.
Faced with competition, some pharmaceutical companies are cutting deals with insurance companies to favor their brand-name products over cheaper generics. Insurers pay less, but sometimes consumers pay more.
Mary Furman, a retired medical social worker in Charlotte, North Carolina, takes the drug celecoxib, the generic version of Celebrex, to treat her rheumatoid arthritis. When she went to fill a 90-day prescription in April, her pharmacy told her she would owe $96.89 if she used her Medicare plan, offered by SilverScript, run by CVS Health.
Then the pharmacy offered her a deal — $72.25 if she paid cash, a price the worker said was the same the pharmacy would offer any customer. "I was flabbergasted," said Furman, who is 72.
Furman took the deal, and afterward, her husband, Nelson, called SilverScript to report what happened. The representative told Nelson Furman he was "not surprised."
The couple then reported the experience to a company hired by Medicare to investigate fraud, but a representative encouraged her to contact the health plan again.
After reporters sent details of Furman's case to CVS, Nelson Furman said they received a call from the SilverScript president. DeAngelis, the CVS spokesman, blamed the pharmacy for charging the couple more than what their share should have been using their insurance. (Medicare rules require that consumers always get the lower price of their set co-payment and a pharmacy's cash price.)
Now the Furmans are looking at drug coverage for next year, and once again, they see huge variation in prices for that drug and others.
"The prices are all over the map," Nelson Furman said.
Many states have laws that allow the donation of drugs, but they don't have programs that get the drugs safely from nursing homes to those who need them.
This article first appeared December 01, 2017 on ProPublica.
Inspired by a ProPublica story in April that described how nursing homes and their pharmacies nationwide throw away hundreds of tons of valuable medicines — and how one Iowa nonprofit successfully recycles them — two states are working to create similar programs.
Other states, including Vermont, are exploring the idea as well.
“All that medicine is perfectly good and perfectly safe,” said Rep. Nicholas Duran, D-Miami, who co-sponsored a bill in Florida modeled on the Iowa program. “Rather than being burned up, it could be put back to some great use.”
ProPublica’s story detailed how the nursing home industry dispenses medication a month at a time, but then is forced to destroy it after patients pass away, stop using it or move out. Some send the drugs to massive regional incinerators or flush them down the toilet, creating environmental concerns.
In Iowa, a program called SafeNetRx retrieves the excess medication, inspects it and dispenses it for free to needy patients. Almost 80,000 Iowans have used SafeNetRx to obtain medication — from cheap antibiotics to cancer drugs worth thousands of dollars per month.
The state funds the program for about $600,000 a year and in fiscal 2016 it recovered and distributed drugs valued at about $3.4 million. This year it’s on pace to hand out more than $6 million of reclaimed medicine.
Many states have laws that allow the donation of drugs, but they don’t have programs that get the drugs safely from nursing homes to those who need them.
After reading ProPublica’s story, Duran, who is also the executive director of the Florida Association of Free and Charitable Clinics, said he visited a long-term care pharmacy and saw firsthand how much valuable medication was being destroyed.
The people at Polaris Pharmacy Services, he said, told him they’d love to donate the medicine, but can’t legally. The new law would create a program to transfer the drugs so they can be dispensed free to patients, he said.
About $400,000 worth of the drugs Polaris dispenses each month are returned because they’ve been stopped for some reason, said David Rombro, the pharmacy’s chief executive. The drugs come back in the same sterile packaging, untainted and unexpired.
Polaris can get credit for about half the unused medication, but the remaining drugs — worth about $2.5 million a year — must be taken away for incineration, he said. Based on the size of his pharmacy and how many others exist in Florida, he estimates about $50 million worth are destroyed annually statewide.
“It’s perfectly good medication,” Rombro said. “There are people that need drugs that don’t have them.”
In New Hampshire, radio show host Arnie Arnesen became excited about the idea after featuring the ProPublica story and the executive director of SafeNetRx on “The Attitude with Arnie Arnesen.” She pitched the drug donation idea to New Hampshire Sen. Dan Feltes, D-Concord, urging him to make it happen in New Hampshire.
“This makes so much sense,” she recalled saying to the senator. “It even fits in with our thrifty values.”
Feltes is now the sponsor of a New Hampshire bill that would create a commission to research how to start a drug donation program like Iowa’s.
Vermont leaders also say the Iowa program would be a good fit for their state, where the “ethos” favors recycling, being environmentally conscious and improving access to medication, said Meg O’Donnell, director of government relations at The University of Vermont Medical Center. There’s a chance Vermont would even hire SafeNetRx in Iowa to run its program, she said.
“We can say pretty confidently there are some real opportunities,” O’Donnell said.
It costs money for nursing homes or pharmacies to properly dispose of the unused medication, Rombro said. Polaris employs two people full time to process the excess drugs, and pays about $5,000 a month to incinerate them.
Other companies and nursing homes simply flush them and trace amounts of pharmaceuticals have been found in water supplies throughout the country. In Florida, wastewater is treated and then pumped into the aquifer, or used to water lawns and golf courses, said Jay Sheehan, senior vice president of Woodard & Curran, a company that runs two utilities in the state. But Sheehan said the wastewater is not treated for possible pharmaceutical contamination.
“We have a problem and we need to collectively address it,” Sheehan said. “The more we can [donate excess drugs] the better we are as a holistic community, because everything is connected.”
Little known to the public, or to sick patients and their families, organs donated domestically are sometimes given to patients flying in from other countries, who often pay a premium.
This article first appeared November 20, 2017 on ProPublica.
Earlier this fall, a leader of the busiest hospital for organ transplants in New York state — where livers are particularly scarce — pleaded for fairer treatment for ailing New Yorkers.
“Patients in equal need of a liver transplant should not have to wait and suffer differently because of the U.S. state where they reside,” wrote Dr. Herbert Pardes, former chief executive and now executive vice president of the board at NewYork-Presbyterian Hospital.
But Pardes left out his hospital’s own contribution to the shortage: From 2013 to 2016, it gave 20 livers to foreign nationals who came to the United States solely for a transplant — essentially exporting the organs and removing them from the pool available to New Yorkers.
That represented 5.2 percent of the hospital’s liver transplants during that time, one of the highest ratios in the country.
Little known to the public, or to sick patients and their families, organs donated domestically are sometimes given to patients flying in from other countries, who often pay a premium. Some hospitals even seek out foreign patients in need of a transplant. A Saudi Arabian company, Ansaq Medical Co., whose stated aim is to “facilitate the procedures and mechanisms of ‘medical tourism,’” said it signed an agreement with Ochsner Medical Center in New Orleans in 2015.
The practice is legal, and foreign nationals must wait their turn for an organ in the same way as domestic patients. Transplant centers justify it on medical and humanitarian grounds. But at a time when President Donald Trump is espousing an “America First” policy and seeking to ban visitors and refugees from certain countries, allocating domestic organs to foreigners may run counter to the national mood.
Even beyond the realm of health care, some are questioning whether foreigners should be able to access limited spots that might otherwise be available to U.S. citizens. For instance, public colleges compensate for reductions in state funding by accepting more foreign students paying higher tuition, and critics say in-state students are being denied opportunities as a result.
Dr. Sander Florman, director of the transplant institute at the Mount Sinai Hospital in New York, said he struggles with “in essence, selling the organs we do have to foreign nationals with bushels of money.”
Mount Sinai has not performed any transplants on patients who came to this country specifically for that purpose, but it has done so for international patients here for other reasons.
Between 2013 and 2016, 252 foreigners came to the U.S. purely to receive livers at American hospitals. In 2016, the most recent year for which data is available, the majority of foreign recipients were from countries in the Middle East, including Saudi Arabia, Kuwait, Israel and United Arab Emirates. Another 100 foreigners staying in the U.S. as non-residents also received livers.
All the while, more than 14,000 people, nearly all of them American citizens, are waiting for liver transplants, a figure that has remained stubbornly high for decades. By comparison, fewer than 8,000 liver transplants were performed last year in the United States — and that was an all-time high. The national median wait time for a liver is more than 14 months, and in states like New York, the wait is far longer. (The wait for livers varies from one state to the next, depending on such factors as the number of organ donors, and the resourcefulness of organ procurement agencies.)
Many patients die before reaching the front of the line. In 2016, more than 2,600 patients were removed from waiting lists nationally because they either died or were too sick to receive a liver transplant.
Most transplant centers only serve American citizens or residents, either by happenstance or by design. Foreign transplants are concentrated among a handful of centers, including NewYork-Presbyterian, Memorial Hermann-Texas Medical Center in Houston (31 such transplants from 2013 to 2016), Ochsner (30), and Cleveland Clinic in Ohio (21).
“When you take people from other parts of the world and provide an organ transplant to them rather than someone who’s here, there’s a real cost, there’s a real life that’s lost,” said Jane Hartsock, a visiting assistant professor of medical humanities and health studies at the Indiana University School of Liberal Arts. Hartsock and her colleagues wrote a journal article published last year saying foreigners should be last in line for a transplant.
NewYork-Presbyterian said it does not advertise its transplant program to foreign patients and that the majority of the transplants it performed on foreign nationals traveling to New York for that reason — 11 of the 20 — were on children under 18.
In a statement, the hospital and its academic partner Columbia University said they follow federal guidelines. “We strongly support efforts that aim to address the critical issue of equitable distribution of livers for transplant and are working closely with a wide range of stakeholders to help increase the number of organ donor registrations in New York State.”
A spokeswoman for the Cleveland Clinic, Eileen Sheil, said her hospital does not actively seek out foreign national business and has a “thoughtful and ethical approach that is well within the rules and aligned with our overall mission for taking care of patients.” Ochsner similarly said, “patients seek out Ochsner’s expertise because of our relentless commitment to provide the highest-quality, complex care.” Memorial Hermann did not respond to requests for comment.
To be sure, the proportion of available livers that go to foreigners is tiny — slightly less than 1 percent of liver transplants nationwide from 2013 to 16. The figure appears to be dropping further in 2017. Even if all recipients were Americans, wait times would still be substantial. Moreover, foreigners queue up on the waitlist like everybody else — although it may be easier for them, since they aren’t rooted in any particular state, to choose a hospital in an area with a shorter wait, such as Ochsner. And some Americans discouraged by the lengthy wait in this country have gone abroad for transplants.
The transplant figures in this article do not include transplants involving living donors, meaning a relative or friend who donates part of his or her liver to a patient. No one interviewed for this story said it is inappropriate for a foreign national to come to the U.S. for a procedure with a living donor.
There’s also an important distinction between giving an organ to a foreigner who happens to be in the U.S. — someone on a student visa or even an undocumented immigrant — and giving one to someone flying over just for surgery. Someone in the first group would be eligible to donate an organ if something happened to them in this country; someone in the latter group would not because livers must be transplanted quickly and there wouldn’t be enough time to ship them.
“If you live in the United States, no matter what your [citizenship] status is, you could potentially be an organ donor if you get hit by a car or something happens to you,” said Dr. Gabriel M. Danovitch, medical director of the kidney and pancreas transplant program at Ronald Reagan UCLA Medical Center, who previously led the UNOS international relations committee. “But if your home is somewhere else, a long way away, there’s no way that you can be a donor or your family or your friends could be donors.
“And in some respects, when you then come to the United States, you are using up a valuable resource that is in great shortage here.”
Foreign patients generally are not entitled to the same discounts as those with private insurance or Medicare, the federal insurance program for seniors and the disabled. In 2015, for instance, the average sticker price for a liver transplant at NewYork-Presbyterian was $371,203, but the average payment for patients in Medicare was less than one-third of that, $112,469, according to data from the Centers for Medicare and Medicaid Services, which runs Medicare. In the case of Saudi Arabia, its embassy in Washington often guarantees payment for patients.
The topic is emerging now because the nation’s transplant leaders will meet next month to consider rewriting the rules governing how livers are distributed, giving programs in New York City, Los Angeles, Chicago and other areas greater access to organs from people who die in nearby regions. The proposal by a committee of the United Network for Organ Sharing, the federal contractor that runs the national transplant system, faces opposition from programs and regions that stand to lose organs. Pardes’ comments were posted in an online comment forum devoted to the proposal, which does not address the issue of transplants for foreigners.
UNOS said it has worked to get better data on foreigners that receive transplants in this country but ultimately, federal law doesn’t prohibit these transplants.
“This is an individual medical decision that the individual transplant hospital makes,” spokesman Joel Newman said. “If we addressed citizenship or residency as a particular reason for whether to accept a patient or not, then that would open up the door to lots of other nonmedical criteria — religion, race, political preference, any number of things that as a community we have decided from an ethical standpoint not to consider.”
UNOS has the authority to ask questions of transplant centers about surgeries on foreign nationals, but Newman said UNOS committees are still trying to figure out what information they would want, and, in any event, the transplant centers don’t have to answer the questions.
The federal rules governing the transplant system, written more than three decades ago, say organ allocation decisions must be based on medical criteria, which would exclude consideration of a person’s nationality or citizenship. While centers can perform as many transplants on foreigners as they want, many programs have tried to keep them below 5 percent of all transplants for each organ type. Until several years ago, 5 percent was the threshold above which UNOS could audit a program. No programs were ever formally audited, and the cutoff was eventually eliminated.
It’s time to revisit the rules, some lawmakers say.
“As a general rule, you’ve got to take care of Americans first as long as you have more demand than supply,” said Sen. John Kennedy, R-La., whose state is home to Ochsner, a leader in transplants for foreign nationals. Kennedy said he would favor curbing transplants for foreigners, while creating a national board that could make exceptions. “But what you don’t want to get into, it seems to me, is subjective areas like well, ‘If this person could live an extra few years, what could they contribute to society?’”
There have been scandals in the past about foreigners and organ transplants. In 2005, a liver transplant center in Los Angeles shut its doors after disclosing that its team had taken a liver that should have gone to a patient at another hospital and instead had implanted it in a Saudi national. The hospital said its staff members falsified documents to cover up the incident.
The University of California, Los Angeles, came under fire in 2008 for performing liver transplants on a powerful Japanese gang boss and other men linked to Japanese gangs, and then receiving donations afterward from at least two of the men. The hospital and its surgeon said they do not make moral judgments about patients.
Further complicating matters is a 2008 document endorsed by transplant organizations around the world, called the Declaration of Istanbul, which seeks to eliminate organ trafficking and reduce transplant tourism internationally. One concern was that patients went to China and received transplants using organs from prisoners. (China said it was stopping the practice in 2015, but experts question whether that has happened.) Another concern was that if a country’s wealthiest or most powerful residents could get transplants overseas, its leaders may not have an incentive to set up a system of their own.
The non-binding declaration also says that there should be a ban on “soliciting, or brokering for the purpose of transplant commercialism, organ trafficking, or transplant tourism.” It was endorsed by UNOS and other national transplant groups.
Former Ochsner employees say they recall Saudi nationals coming for transplants, some wealthy and some not. A New Orleans bar posted a photo on Facebook in 2015 of a young man who brought his mom from Saudi Arabia for a transplant.
Ochsner said in a statement that it was proud of its liver transplant program, which is the nation’s largest. It said that it is willing to accept donated organs that other centers turn down for medical reasons, expanding its ability to help patients while keeping its survival rate high. And it noted that the median waiting time for its patients is only 2.1 months, far below the national median.
“UNOS does not have any restrictions preventing transplant for international patients and they are subject to the same guidelines as domestic patients,” the statement said.
Still, many American candidates for livers don’t make Ochsner’s waiting list. It refused to put Brian “Bubba” Greenlee Jr. on its list right after Christmas in 2015, because of his “poor insight into his drinking and lack of proper social support,” his medical records show. He had cirrhosis and died weeks later at age 45.
His sister, Theresa Greenlee-Jeffers, said Ochsner led her brother to believe that he would get a new liver. Her brother had stopped drinking and she had volunteered to take care of him after a transplant, but then the hospital suddenly reversed course.
“His last Christmas, he was given false hope that he was going to get a transplant. That’s not OK. You don’t play with somebody’s emotions like that,” Greenlee-Jeffers said.
Ocshner did not answer questions about Greenlee’s care but said in its statement, “Not every patient is a candidate for transplant.” It said its criteria are similar to those of other liver transplant centers.
“At Ochsner, we are caregivers, dedicated to providing our patients with high-quality care, improved outcomes and the gift of a second chance at life,” its statement said.
Greenlee-Jeffers wonders if Ochsner excluded her brother and other Americans to make room for foreigners willing to pay more. “It’s not OK,” she said. “We need to take care of our people here at home first. We don’t have enough of this to go around.”
Following in the steps of Baltimore and Philadelphia, New York City is establishing a committee to review deaths and severe complications related to pregnancy and childbirth, aiming to reduce their toll on expectant and new mothers in the nation’s largest metropolis.
There’s ample room for improvement: The city’s maternal mortality rate is thought to be slightly above average for the U.S., which has the highest such rate in the industrialized world. Of the estimated 700 to 900 deaths related to pregnancy and childbirth nationwide each year, New York City accounts for about 30.
Moreover, the city’s outcomes feature a worsening racial divide. Between 2006 and 2010, black women were 12 times more likely than white women to die from pregnancy-related causes, up from seven times more likely between 2001 and 2005.
The new committee will dig deeper into each maternal death than has previously been possible and, by mining their causes and circumstances, will guide efforts to prevent such tragedies, city health officials said.
“We want to advocate for quality improvement, not just in the city [overall], but in all the hospitals in the community,” said Dr. Lorraine Boyd, medical director of the city health department’s Bureau of Maternal, Infant and Reproductive Health. “We want to be able to say that the rates of maternal mortality, that the [racial] gap is closing and that we’ve put programs in place that are going to lead to that.”
The panel (officially named the Maternal Mortality and Morbidity Review Committee, but already nicknamed M3RC) is scheduled to hold its inaugural meeting in early December and convene four times a year thereafter.
It will have up to 45 members, including not only doctors and nurses, but also doulas, midwives and social workers — “people in the community, who can better reflect how women live their lives,” Boyd observed.
Beyond examining maternal deaths, the panel will also compile and analyze data on severe complications experienced by expectant and new mothers. For every death, experts say there are dozens of cases of such complications, affecting more than 50,000 American women each year.
New York state has had a maternal mortality review committee since 2010 that examined cases statewide, including those in the city; the city has also had its own panel to assess death data in aggregate.
Officials said the city’s new review committee will work hand-in-hand with that of the state, with the city panel reviewing deaths within the five boroughs and the state committee reviewing those outside. The committees will collect a standardized set of data and pool their findings in a statewide report, said Jill Montag, a spokeswoman for the New York State Department of Health.
Beyond its potential to improve outcomes, health officials in New York and beyond said they see the city’s creation of a review committee as a step toward better, more complete data on maternal deaths.
Nationally, such data is so unreliable and incomplete that the United States has not published official annual counts of fatalities or an official maternal mortality rate in a decade.
Unlike the United Kingdom, widely considered the gold standard for maternal mortality data, the U.S. lacks a national system for reviewing pregnancy-related deaths.
Slightly more than half the states and a smattering of cities have active, stable maternal mortality reviews, but many get little or no funding and rely on volunteers to do time-consuming case analyses. Some large states have more deaths to review than one committee can reasonably handle and sometimes skip years or look into subsets of cases rather than reviewing every death.
Adding city committees that can shoulder a portion of the work “makes a lot of sense,” said David Goodman, who oversees maternal health efforts at the Centers for Disease Control and Prevention’s maternal and infant health branch. “The New York City and New York state collaboration is the first we are aware of, and perhaps a model approach for other large states to consider.”
Goodman also leads a privately funded effort to bring together and standardize data from state and local maternal mortality review processes. To do this, the initiative has created a tool, the Maternal Mortality Review Information Application, and New York City and New York state are among 12 jurisdictions nationwide that have begun using it. Another 13 are preparing to do so, Goodman said.
New York City officials said the new committee would be funded partly through a grant but would not specify the funder or the grant amount because the contract isn’t signed yet. Eight staffers at the city health department will work part time on the project, giving it anywhere from 5 percent to 90 percent of their time.
“This is something that we’re committed to, that the city has prioritized, that the health department has committed to fund and to see work,” said Carolina Rodriguez, deputy press secretary for the New York City Department of Health and Mental Hygiene.
Two U.S. senators introduced legislation Tuesday requiring federal agencies to come up with solutions to the waste caused by oversized eyedrops and single-use drug vials, citing a ProPublica story published earlier this month.
The bipartisan effort by Sens. Amy Klobuchar, D-Minn., and Chuck Grassley, R-Iowa, calls for the Food and Drug Administration and the Centers for Medicare and Medicaid Services to come up with a plan to reduce the waste, which is estimated to cost billions of dollars a year.
“With the skyrocketing costs of prescription drugs, American taxpayers shouldn’t be footing the bill for medicine going to waste,” Klobuchar said in a press release announcing the bill, known as the Reducing Drug Waste Act of 2017. Sens. Dick Durbin, D-Ill., and Jeanne Shaheen, D-N.H., are co-sponsors of the legislation.
Grassley called it “common sense” legislation. “It’s no secret that wasteful health care spending is a significant contributor to the rising cost of health care in the United States,” he said in the release.
ProPublica’s story showed how drug companies force patients to pay for expensive liquid medications, such as eyedrops and cancer drugs, which are produced or packaged in ways that lead to waste. Drug companies have known for decades that eyedrops are larger than what the eye can hold — sometimes two or three times too big. As a result, the excess medication overflows the eye and runs down users’ cheeks or is ingested through their eye ducts. This waste causes some patients to run out of medicine before their insurers allow them to refill their prescriptions.
Some of the largest producers of eyedrops — from expensive vials for eye conditions like glaucoma to over-the-counter drops for dry eyes — have done research to show that smaller drops work just as effectively. But they have continued to produce larger drops. Novartis, owner of Alcon, one of the leading eye care companies, said the larger drop size allowed a margin of safety to help patients administer the drops. Other eyedrop makers declined to comment.
ProPublica also examined how the packaging of cancer drugs often results in some of the drug being tossed in the trash. The drug company Genentech, for example, switched earlier this year from sharable vials of its cancer drug Herceptin to single-use vials, causing excessive waste. One California cancer center estimated the change would lead to an average of $1,000 in wasted medicine per patient, per infusion. Patients are billed for such waste.
ProPublica also cited research led by Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York. Bach’s study, also reported in 2016 in The New York Times, found that single-use cancer vials wasted nearly $3 billion annually in cost increases and medicine that must be thrown away.
“From cancer drugs to expensive eye-drops, many drug companies insist on selling their products in excessively large, one-size-fits-all vials that contain more medicine than the average patient needs,” said Durbin, one of the lawmakers sponsoring the bill. “This is a colossal and completely preventable waste of taxpayer dollars, and it means American patients and hard-working families are paying for medication that gets tossed in the trash.”
Bach’s study proposed making drug companies produce vials in additional sizes, so they could be delivered in a way that’s more efficient, or requiring drug companies to give rebates on unused medicine. He said it’s too early to know what the federal government’s solution would be, but the new bill is a positive step forward.
“This could be legislation that saves Medicare and sick patients a lot of money,” Bach says.
Dr. Alan Robin, a Baltimore ophthalmologist whose research was featured in ProPublica’s story, has been urging drug companies to reduce the size of their eyedrops for decades. When he heard Monday about the senators’ proposed legislation, he started to cry.
“I’m literally crying with joy,” Robin says. “I’m very concerned about both the cost issues associated with waste, the side effects on patients, and also the environmental impact of waste."
An audit released late last week by the New York state comptroller’s office found the state’s Education Department, which regulates nursing, failed to investigate top-priority complaints against nurses in the time allowed by law.
It also found nurses’ backgrounds were not adequately checked and that they were not properly monitored for criminal behavior after licensure.
All of these findings confirm those in a ProPublica investigation into New York’s nursing regulations published in April of 2016.
“The report underscores a problem we already knew existed,” said state Sen. Kemp Hannon, who has co-sponsored two bills — one in 2016 and one in 2017 — aimed at correcting problems identified by ProPublica. In 2016, the bill passed the Senate with a single “no” vote but never received a vote in the Assembly. In 2017, the bill passed the Senate unanimously, but the Assembly never proposed a bill or moved on the Senate bill.
“The roadblock lies squarely at the hands of the Assembly,” Hannon said. “At some point they have to bow to the need for action.”
Assembly member Deborah Glick, who sponsored 2016 legislation similar to the Senate’s, said the Assembly is “working assiduously” towards a bill. She said earlier versions of the legislation did not respect the due process rights of licensed professionals, particularly by allowing regulators to summarily suspend professionals’ licenses before they had a chance to respond in some cases. In other states, regulators have the power to do this when there is an urgent threat to safety.
“We understand the critical importance of protecting the public, but we also understand that licensed professionals are entitled to their due process rights,” she said. She said a solution was almost reached this legislative session, but other initiatives “diverted” the higher education committee’s attention. She said she would make it a priority to pass legislation at the start of the next session, which begins in January 2018.
Mark Johnson, a spokesman for the comptroller’s office, said that while audits of state departments are routine, ProPublica’s reporting was “a factor” in the decision to investigate nursing regulations.
As ProPublica reported, the Education Department relies on nurses to self-disclose misconduct and criminal convictions. In New York, nurses are only required to make these disclosures every three years when they renew their licenses, which the comptroller’s audit noted “[enables] nurses who have been sanctioned to practice in the interim.”
“As a result, the Department cannot be assured that all episodes of misconduct are identified properly and in a timely manner, and that nurses who pose a threat to the public’s health and safety are prevented from practicing in New York State,” the audit said.
Both the 2016 and 2017 Senate bills, sponsored by Sen. Kenneth LaValle and co-sponsored by Hannon, would have fixed the vast majority of the problems identified by ProPublica and the recent audit. Aimed at all 54 professions licensed by the Education Department, both bills would have allowed the department to summarily suspend the licenses of professionals suspected of extreme misconduct. The measures also defined “moral character” requirements for licensed professions, and required professionals to inform the department of criminal convictions within 30 days.
Hannon said he will continue to pursue a solution for the problems referenced in the comptroller’s audit. If the legislature will not act to fix holes in the oversight of all 54 professions licensed by the state, he said he may propose legislation aimed directly at nursing or move to have the regulation of nurses moved from the Education Department to the Health Department, which regulates doctors and physician assistants. New York is the only state in the country that assigns the regulation of nursing to the Education Department.
Under the Education Department’s supervision, New York has continued to allow nurses who have harmed patients to retain active nursing licenses.
ProPublica’s report highlighted the case of Linda Ansa, a Bronx nurse who the New York Health Department found had nearly killed a 99-year-old nursing home resident by administering 50 times the necessary dose of insulin.
Nursing homes in New York are regulated by the Health Department, which penalized Ansa in 2014 before referring her case to the Education Department for action against her license. But more than three years after her case was referred, no action has been taken. Her license remains clear. Neither Ansa nor the attorney who represented her in the Health Department case has responded to requests for comment.
The Education Department declined to comment on Ansa’s case and typically declines to answer questions on specific disciplinary actions. A spokesman for the department, Jonathan Burman, said in a statement that all allegations of misconduct are taken “extremely seriously.” He said that the department has “sought legislation to modernize and enhance our authority over licensed professions” for the past two years.
“We will continue to work with the legislature to get this important public protection bill enacted,” he said.
In a response included in the comptroller’s audit, the Education Department said its budget has not kept pace with its increasing responsibilities. The professions regulated by the Education Department range from nursing to landscape architecture and the number of professions the agency oversees has increased steadily over the decades. According to the audit, receipts from fees collected by the department have risen from $41.5 million in 2010-2011 to $53.5 million in 2016-2017. The department’s appropriation in the state budget, however, has stayed at $45.1 million over the same period. The department also told the comptroller’s office its antiquated computer system made it difficult to efficiently handle its caseload.
The state commissioner of education, MaryEllen Elia, has 90 days to report to the comptroller, the governor and the legislature on what steps the Education Department has taken to implement the comptroller’s recommendations.
The recommendations include streamlining and more closely tracking investigations, strengthening controls over “moral character” requirements for nurses and researching the best practices of other states.
Donna Nickitas is the executive officer of the nursing Ph.D. program at the Graduate Center of the City University of New York. She called the comptroller’s recommendations obvious and said she was “greatly disappointed” that neither the Legislature nor the Education Department had undertaken those improvements over the last year and a half.
“[ProPublica] came to the table so long ago with evidence showing other states were far ahead of us,” she said. “In the private sector, they fire people over this.”
A U.S. senator whose state has been devastated by the opioid epidemic sent letters Tuesday asking two major health insurance companies to remove barriers to non-opioid pain treatments.
The letters from Sen. Joe Manchin, D-W.Va., follow a story by ProPublica and The New York Times, which detailed how insurers have restricted access to pain medications that carry a lower risk of addiction or dependence, even as they provided comparatively easy access to cheaper, generic opioid medications.
“The practices detailed in the article are the exact opposite of what we need and will only serve to worsen the opioid epidemic, putting more people at risk of opioid addiction and overdose death,” Manchin wrote in letters to David S. Wichmann, chief executive of UnitedHealth Group, and Joseph R. Swedish, chief executive of Anthem Inc.
“Specifically, I ask you to reduce or eliminate the barriers that your beneficiaries face to access non-opioid pain medications and physical therapy for pain management. Just as importantly, I urge you to ensure that every beneficiary that you serve that needs substance use disorder treatment, including behavioral health counseling, is able to affordably access it.”
UnitedHealth was cited in the story because it stopped covering Butrans, a painkilling skin patch that contains buprenorphine, an opioid that has a lower risk of abuse and dependence than generic, long-acting opioids. As a result, a patient said she turned to long-acting morphine to control her pain, went to the emergency room because she could not control her pain, and now visits her doctor more often than before.
Anthem denied a request for Lyrica, a non-opioid, brand-name drug, for a patient who had been using it successfully to treat the pain associated with interstitial cystitis, a chronic bladder condition. 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.
UnitedHealth and Anthem defended their decisions and said they take the opioid crisis seriously. Bothcompanies said they have been able to successfully decrease the number of opioid prescriptions taken by members.
In a statement Tuesday, Anthem said, “We share the Senator’s concerns about overdoses in West Virginia and the entire country, and agree that more needs to be done to address the opioid epidemic. That’s why Anthem is addressing the opioid epidemic through a holistic approach involving prevention, treatment and recovery and deterrence.”
Anthem said a West Virginia affiliate, Unicare Health Plan of West Virginia, is expanding a program to offer substance use treatments as part of primary care, removing the stigma that may be attached to it. The insurer also said it covers non-opioid pain relief drugs “according to best clinical practice guidelines and scientific evidence,” noting that some carry retail prices of $350 to $1,500 per prescription.
UnitedHealth has not yet responded to a request for comment.
Until recently, the role of insurers in fanning — or at least failing to stop — the opioid crisis has not received as much attention as that of other players, including pharmaceutical companies, doctors and drug distributors.
A day after the ProPublica/New York Times story was published, attorneys general for 37 states sent a letter to the health insurance industry’s main trade group, urging its members to reconsider coverage policies that may be fueling the opioid crisis.
“The status quo, in which there may be financial incentives to prescribe opioids for pain which they are ill-suited to treat, is unacceptable,” the letter said. “We ask that you quickly initiate additional efforts so that you can play an important role in stopping further deaths.”
Insurers say they have been addressing the issue on many fronts, including monitoring patients’ opioid prescriptions, as well as doctors’ prescribing patterns. Moreover, at least two large pharmacy benefit managers, which run insurers’ drug plans, announcedthis year that they would limit coverage of new prescriptions for pain pills to a seven- or 10-day supply.
Manchin’s daughter, Heather Bresch, is the chief executive of Mylan, a major pharmaceutical company. Mylan last month disclosed that it had received a subpoena from the Department of Justice seeking information about its manufacturing and sales of opioids. The company said it was cooperating.
While opioids such as hydrocodone and morphine are often prescribed to relieve pain, they also have been linked to abuse and dependence. Drug overdoses are now the leading cause of death among Americans under 50, and more than 2 million Americans are estimated to misuse opioids.
For our story earlier this month, ProPublica and the 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. 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 from the insurer for them.
Moreover, we found that many plans make it easier to get opioids than medications to treat addiction, such as Suboxone. Drug plans covering 33.6 million people include Suboxone, but two-thirds require prior authorization. And even if they do approve coverage, some insurance companies have set a high out-of-pocket cost for Suboxone, rendering it unaffordable for many addicts, a number of pharmacists and doctors said.
In his letters, Manchin asked UnitedHealth and Anthem to share their plans for addressing the crisis. “We have lost too many Americans to the opioid epidemic,” he wrote. “I hope that your company will be a part of the solution.”
In their letter to AHIP, the attorneys general urged insurers to revise their rules "to encourage healthcare providers to prioritize non-opioid pain management options over opioid prescriptions for the treatment of chronic, non-cancer pain."
This article first appeared September 18, 2017 on ProPublica.
Attorneys general for 37 states sent a letter Monday to the health insurance industry’s main trade group, urging its members to reconsider coverage policies that may be fueling the opioid crisis.
The letter is part of an ongoing investigation by the state officials into the causes of the opioid epidemic and the parties that are most responsible. The group is also focusing on the marketing and sales practices of drug makers and the role of drug distributors.
On Sunday, ProPublica and The New York Times reported that many insurance companies limit 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 safer drugs are more expensive.
In their letter to America’s Health Insurance Plans, the trade group based in Washington, D.C., the attorneys general urged insurers to revise their rules “to encourage healthcare providers to prioritize non-opioid pain management options over opioid prescriptions for the treatment of chronic, non-cancer pain.”
“The status quo, in which there may be financial incentives to prescribe opioids for pain which they are ill-suited to treat, is unacceptable,” the letter said. “We ask that you quickly initiate additional efforts so that you can play an important role in stopping further deaths.”
The signatories include the attorneys general of California, Florida, New York, Pennsylvania and Michigan.
While opioids, such as hydrocodone and morphine, are often prescribed to relieve pain, they also have been linked to abuse and dependence. Drug overdoses are now the leading cause of death among Americans under 50, and more than 2 million Americans are estimated to misuse opioids. While the crisis has placed the practices of drug makers, pharmaceutical distributors, pharmacies and doctors under scrutiny, the role of insurers in enabling access to cheap, addictive opioids has received less attention.
The Department of Health and Human Services is now studying whether insurance companies make opioids more accessible than other pain treatments. An early analysis suggests that insurers 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.
Last week, the New York state attorney general’s office sent letters to the three largest pharmacy benefit managers — CVS Caremark, Express Scripts and OptumRx — asking how they were addressing the crisis.
In a written statement to ProPublica, Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, said that, “We share the state attorneys general’s commitment to eradicating the opioid epidemic in America.”
“Health plans cover comprehensive, effective approaches to pain management that include evidence-based treatments, more cautious opioid prescribing, and careful patient monitoring,” Donaldson wrote. “Recent research shows that non-opioid medications, even over-the-counter medication like ibuprofen, can provide just as much relief as opioids.”
Insurers say they have been addressing the issue on many fronts, including monitoring patients’ opioid prescriptions, as well as doctors’ prescribing patterns. A number of companies say they have seen marked declines in monthly opioid prescriptions in the past year or so. Moreover, at least two large pharmacy benefit managers, which run insurers’ drug plans, announcedthis year that they would limit coverage of new prescriptions for pain pills to a seven- or 10-day supply.
“Patients and their care providers should talk openly and honestly about pain and how to manage it — from lifestyle changes and exercise to over-the-counter options and clearly understanding the dangers of opioids,” Donaldson said.
Nonetheless, ProPublica and The New York Times found that companies are sometimes refusing to cover less risky drugs prescribed by doctors while putting no such restrictions on opioids.
We 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 from the insurer for them.
Moreover, we found that many plans make it easier to get opioids than medications to treat addiction, such as Suboxone. Drug plans covering 33.6 million people include Suboxone, but two-thirds require prior authorization. And even if they do approve coverage, some insurance companies have set a high out-of-pocket cost for Suboxone, rendering it unaffordable for many addicts, a number of pharmacists and doctors said.
“Everyone — including and especially insurance companies — have an obligation to address the opioid epidemic,” New York Attorney General Eric T. Schneiderman said in a press release today. “Insurers must take a hard look at the systemic problems in our healthcare system that result in the over-prescription of opioids and fuel the cycle of addiction.”
