The situation in Charlottesville has left many residents at their wits' end about how to pay for their health insurance, thrusting the costs of coverage into the center of local politics.
CHARLOTTESVILLE, Va. — When Garnett and Dave Mellen sent their 19-year-old daughter, Gita, off to college an hour away at Virginia Commonwealth University last fall, they didn’t expect to follow her.
But in November, the family received notice that its monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600.
So, the Mellens, both longtime local business owners, packed their bags and spent time with Gita in her off-campus apartment in Richmond.
“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen, 56, said, as she explained that claiming residency with her daughter in the new ZIP code had cut their premiums by more than half.
Charlottesville now claims the dubious distinction of having the highest individual-market health insurance costs in the country — prompting families like the Mellens to look for extreme solutions.
An exodus of carriers, which was blamed on losses caused by the instability of the Obamacare marketplace, created a coverage vacuum, leaving locals and insurance regulators scrambling.
Only one carrier — Virginia Beach-based Optima Health — decided to continue to participate in the individual market, but it did so with monthly premium increases that were, on average, in the high double-digits and for some consumers as much as 300 percent, according to people interviewed for this story.
It’s a problem that’s likely to be replicated elsewhere, said Timothy Jost, an emeritus professor of law at Washington and Lee University in Virginia and expert on the health law.
“In many states, it’s going to be hard to maintain a functional individual market,” he said. “Charlottesville is sort of ahead of everybody else in this … but this is the direction things are heading.”
Insurers nationwide that intend to participate in the individual market face spring deadlines to file forms for 2019 plans and rate proposals. In Virginia, these dates are April 20 and May 4, respectively.
The situation in Charlottesville has left many residents at their wits’ end about how to pay for their health insurance, prompting the evolution of an angry and rebellious civic movement and thrusting the costs of coverage into the center of local politics.
Charlottesville for Reasonable Health Insurance, a grass-roots organization and Facebook group of more than 700 people, has already claimed small victories in the state legislature, such as propelling the passage of a bill that will alleviate the cost burden for some of its members.
But its highest priority has been pressing state regulators to explain and possibly reconsider the decision that allowed for the stunning premium increase.
In the midst of various bureaucratic fits and starts, the state Bureau of Insurance (BOI) responded to the group April 11 by reiterating that Optima’s rates were “actuarially justified.” Ian Dixon, one of the group’s organizers, said it plans to appeal this finding to the State Corporation Commission.
“We’re not going away, that’s for sure,” said Dixon. “They’re hoping they can wait us out. … They would drag this out for a year if they could.”
At the same time, the group has expanded its focus to other issues on health care costs, such as price transparency and regulatory reform.
How It Came To This
The trouble started in summer 2017, when the state’s major insurance carriers announced they would be leaving the individual market in Virginia, saying the market was “shrinking and deteriorating” — pointing to the instability of Obamacare under the Trump administration.
Their departures left Albemarle County, home to Charlottesville, bare — meaning residents had no insurance options.
When Optima opted to continue to offer plans in and around Charlottesville, state insurance regulators breathed a collective sigh of relief.
But Optima’s decision came with updated rate increase proposals, which gained the OK of the under-the-gun BOI, led by Commissioner Scott White.
“I think the [regulators] decided they were willing to accept almost anything to get someone to cover Albemarle County and Charlottesville,” Jost said.
About 15 miles north of Charlottesville on U.S. 29, there’s a billboard that some residents now view with bitter irony. It features a smiling man with the message: “I chose Optima.”
On one hand, Optima did fill a void and offer health plans where no other insurer would. Still, many residents found their only choice came with a 300 percent boost in premium costs. They felt that state regulators had fallen short of their consumer-protection responsibilities.
“Any assumption that I had … that I thought [the Bureau of Insurance would be] protecting the people … was completely naive,” said Sarah Stovall, 40, who works for a small software company, lives in Charlottesville with her husband and two sons and has struggled to find affordable coverage.
But Ken Schrad, the director of the Division of Information Resources for the State Corporation Commission, said the bureau is still questioning Optima, checking its math and evaluating its actuarial decisions.
He couldn’t answer specific questions about a matter he said is pending.
Schrad said the bureau reached out to carriers and worked with them last summer when it was clear that much of the commonwealth wouldn’t be covered.
“It wasn’t a question of what the premiums would be,” Schrad said. “It was whether there would be any coverage.
“[Filings] must be based on actuarially sound decisions, and that’s all the bureau can review. The market is the market.”
A Movement Is Born
Stovall, 40, teamed up with Dixon, 38, a web app developer, to manage the emerging Facebook group, which was originally set up as a support system for people in search of new insurance options in a short window of time. Soon, Karl Quist, 46, who had been actively calling the BOI to lodge complaints, joined the effort.
“The three of us did not know each other before November,” Dixon said. “We feel like we’re relatives now.”
Others quickly piled on, including the Mellens and Gail Williamson, 64, a part-time secretary at a private school who needed insurance for herself and her husband, who owns a business restoring antiques.
Like many of the people in the group, the Williamsons made too much money to qualify for federal subsidies, but too little to be able to afford the $3,725 monthly premium that Optima would have charged them.
Sharing their knowledge, many Charlottesville for Reasonable Health Insurance members have resorted to imperfect jury-rigged policies that do not come with many of the coverage guarantees that protect patients from unexpected costs under the Affordable Care Act.
Instead of paying $2,920 a month for Optima’s least generous family health plan, Quist is saving $2,300 a month by purchasing two non-ACA-compliant plans, one for sickness and one for accidents.
Williamson has settled on a “silly little” three-month policy for $1,400 per month, plus an extra $35 a month in supplemental accident insurance for her husband.
“If I won the lottery, the first thing I’d do before giving my kids any money would be to buy health insurance for everyone in that group,” Williamson said.
Washington and Lee’s Jost said he worries about the impact of such cobbled-together coverage.
He said having these plans could damage the ACA market further by skimming the healthier people away from the more comprehensive coverage, leaving behind those who are ill or have chronic conditions.
“It makes the situation worse because the only people who are going to pay premiums that high are people who are desperate,” Jost said.
Forward Motion
Over the past months, the community-based effort has evolved beyond being an ad hoc information clearinghouse into a powerful organizing tool.
For instance, it has raised almost $20,000 to hire lawyer Jay Angoff, a former federal and state insurance official, to appeal to Optima and state regulators about the Charlottesville-area rates.
Dixon, Stovall and Quist also regularly pile into Stovall’s minivan, drive to Richmond and become lobbyists for their cause.
“The insurance companies pay people very good money to lobby for them on a regular basis,” Stovall said. “Meanwhile, I have to take off work, Ian [Dixon] has to leave his business for a day.”
“On some level, I have faith that if we keep pushing, I don’t know what the eventual outcome will be, but we’ll find some type of justice,” Dixon added.
Their greatest victory came with the passage of SB 672. This law redefined what a “small employer” is so that self-employed people can buy insurance in the small-group market.
The group sought this change because many people, including Dixon, found that the cost of adding an employee to a company of one allowed them to save money by obtaining insurance as a small group, though it still added significant overhead costs to these businesses.
Many in the group see this success as only a band-aid fix. Though it allows some people to obtain cheaper insurance, it doesn’t address the root of the problem: Optima’s rate increases.
For Garnett Mellen, though, the issue seems resolved, at least for now. She found a job with health benefits in Charlottesville, which enabled her and her husband to move back there.
It’s a big relief — both for her and for Gita, her college-aged daughter.
“She [was] not entirely happy with us being there,” Mellen said.
Under the new rules, people can apply for a hardship exemption that excuses them from having to have health insurance if they, for example, live in an area where there is just one insurer selling marketplace plans.
There are already more than a dozen reasons people can use to avoid paying the penalty for not having health insurance. Now the federal government has added four more “hardship exemptions” that let people off the hook if they can’t find a marketplace plan that meets not only their coverage needs but also reflects their view if they are opposed to abortion.
It’s unclear how significant the impact will be, policy analysts said. That’s because the penalty for not having health insurance will be eliminated starting with tax year 2019, so the new exemptions will mostly apply to penalty payments this year and in the previous two years.
“I think the exemptions … may very marginally increase the number of healthy people who don't buy health insurance on the individual market,” Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia who is an expert on health law.
Under the new rules, people can apply for a hardship exemption that excuses them from having to have health insurance if they:
Live in an area where there are no marketplace plans.
Live in an area where there is just one insurer selling marketplace plans.
Can’t find an affordable marketplace plan that doesn't cover abortion.
Experience “personal circumstances” that make it difficult for them to buy a marketplace plan, including not being able to find a plan in their area that gives them access to specialty care they need.
The first new exemption isn’t relevant for consumers this year. Since the Affordable Care Act’s marketplaces opened, there have been no “bare” counties that lack insurers.
However, in about half of the U.S. counties — in which 26 percent of enrollees live — there is only one marketplace insurer this year, according to the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)
As for the abortion exemption, in many places it won’t be an issue either. Women in 31 states didn’t have access to a marketplace plan that covered abortion in 2016, according to a Kaiser Family Foundation analysis. Still, a few states — California, New York and Oregon — generally require abortion coverage in their marketplace plans, and women who live there might have trouble finding a plan that excludes that coverage, experts said.
The ACA established several different types of exemptions from the penalty for not having coverage. Among them are exemptions for not being able to find coverage that is considered affordable or being without insurance for less than three consecutive months in a year. People claim these more common exemptions when they file their tax returns.
Hardship exemptions that had already been on the books protected people who faced eviction, filed for bankruptcy or racked up medical debt, among other difficulties. Consumers apply for these exemptions by submitting an application to the ACA insurance marketplace.
The new hardship exemptions apply to people in all 50 states, according to an official at the federal Centers for Medicare & Medicaid Services, which oversees the health law’s insurance marketplaces. To apply, people generally need to provide a brief explanation of the circumstances that made it a hardship for them to buy a marketplace plan, along with any available documentation, when they submit their application to marketplace officials. They can apply for the current calendar year or going back two years, to 2016.
It’s difficult to gauge how many people will try to take advantage of the changes, said Tara Straw, a senior policy analyst at the Center on Budget and Policy Priorities.
“People aren’t sure how to apply or if they’re eligible, and that discourages them from applying,” Straw said.
During the 2017 filing season, there were more than 106 million tax returns reporting that all family members had health insurance, and nearly 11 million tax returns that claimed an exemption from the requirement to have it, according to a report from the Treasury Department’s inspector general for tax administration. In addition, more than 4 million returns reported paying penalties totaling nearly $3 billion for not having health insurance.
People often don’t realize they may owe a penalty until it’s time to do their taxes, said Alison Flores, a principal tax research analyst at H&R Block’s Tax Institute. H&R tax preparers first work to see if clients can qualify for an exemption that can be claimed on their tax returns. If that doesn’t work, they move on to the hardship exemptions. The preparers help people get the hardship exemption application, but it’s up to consumers to send it to the marketplace and get the exemption certificate.
The federal guidance about the new exemptions was released April 9, shortly before the end of the income tax filing season. People who’ve already filed their taxes and qualify for the new exemptions for 2016 or 2017 and get marketplace approval can file an amended tax return to receive a refund of any penalty they paid, said Katie Keith, a health policy consultant who writes regularly about health reform.
In an ominous sign for patient safety, 71 percent of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study.
The paper, published last month in the American Journal of Infection Control, underscores the infection risk posed by a wide range of endoscopes commonly used to peer deep into the body. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination despite numerous reports of superbug outbreaks and patient deaths, experts say.
“These results are pretty scary,” said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. “These are very complicated pieces of equipment, and even when hospitals do everything right we still have a risk associated with these devices. None of us have the answer right now.”
The study found problems in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine operations. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at UCLA’s Ronald Reagan Medical Center. Scope-related infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Pasadena’s Huntington Hospital.
The bacteria this latest study found weren’t superbugs, but researchers said there were potential pathogens that would put patients at high risk of infection. The study didn’t track whether the patients became sick from possible exposure.
The study’s authors said the intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when health care workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes, among others.
“Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” said Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minn., referring to how the devices are prepared for reuse.
“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead said.
The rise of antibiotic-resistant superbugs such as CRE (carbapenem-resistant Enterobacteriaceae), which can be fatal in up to half of patients, has made addressing these problems more urgent. About 2 million Americans are sickened by drug-resistant bacteria each year and 23,000 die, according to the federal Centers for Disease Control and Prevention.
“We’re not moving fast enough to a safer world of reusable medical devices,” Michael Drues, an industry consultant in Grafton, Mass., who advises device companies and regulators. “There is plenty of fault to go around on device companies, hospitals, clinicians, on basically everybody.”
Despite the potential risks, medical experts caution patients not to cancel or postpone lifesaving procedures involving endoscopes. These snake-like devices often spare patients from the complications of more invasive surgeries.
“Patients should speak to their provider and think about the risks versus the benefits,” said Haas, who is also director of epidemiology at Lenox Hill Hospital in New York City.
The Food and Drug Administration and Olympus Corp., a leading endoscope manufacturer in the U.S. and worldwide, both said they are reviewing the study.
Last month, the FDA issued warning letters to Olympus and two other scope makers for failing to conduct real-world studies on whether health care facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the manufacturers to conduct those reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines.
Olympus spokesman Mark Miller said the Tokyo-based company intends to “meet the milestones set forth by the FDA. … Patient safety has always been and remains our highest priority.”
The latest study examined 45 endoscopes, with all but two manufactured by Olympus. The other two were Karl Storz models.
Last year, researchers visited three hospitals, which weren’t named, and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met the current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocol.
Nevertheless, 62 percent of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was even worse at the other two — 85 and 92 percent.
The study painted a troubling picture at the two lower-performing hospitals, which were well aware researchers were watching.
Among the safety issues: Hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.
“It was very disturbing to find such improper practices in big health systems, especially since these institutions were accredited and we assumed that meant everything would have been done properly,” said Ofstead, chief executive of the medical research firm Ofstead & Associates.
Ofstead and her co-authors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.
In their current form, many endoscopes aren’t built to withstand repeated sterilization. Some also have long, narrow channels where blood, tissue and other debris can get trapped inside.
In some cases, disposable, single-use scopes are an option, and new products are starting to gain acceptance. In other instances, certain parts of a scope might be disposable or removable to aid cleaning.
The Joint Commission, which accredits many U.S. hospitals and surgery centers, issued a safety alert last year about disinfection and sterilization of medical devices in response to a growing rate of noncompliance. In 2016, the Joint Commission cited 60 percent of accredited hospitals for noncompliance and 74 percent of all “immediate threat to life” citations from surveyors related to improperly sterilized or disinfected equipment.
Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba, said accreditors may need to conduct more frequent inspections and endoscopy labs should be shut down “if they don’t get their act together. These results are totally unacceptable.”
While other states are making efforts to preserve the ACA and expand coverage, California stands out by virtue of its ambition and size, economic clout, massive immigrant population and liberal bent.
These days, when the federal government turns in one direction, California veers in the other — and in the case of health care, it’s a sharp swerve.
In the nation’s most populous state, lawmakers and other policymakers seemingly are not content simply to resist Republican efforts to dismantle the Affordable Care Act. They are fighting to expand health coverage with a series of steps they hope will culminate in universal coverage for all Californians — regardless of immigration status and despite potentially monumental price tags.
The Golden State embraced the health care law early and eagerly, and has more to lose than any other state if the ACA is dismantled: About 1.5 million Californians purchase coverage through the state’s Obamacare exchange, Covered California, and 3.8 million have signed up for Medicaid as a result of the program’s expansion under the law.
While other states are making efforts to preserve the ACA and expand coverage, California stands out by virtue of its ambition and size, economic clout, massive immigrant population and liberal bent.
Its health care resistance movement is broad and includes Attorney General Xavier Becerra, who has made a sport of suing the Trump administration. He is currently leading a coalition of 15 states, plus the District of Columbia, against a Texas-based lawsuit that seeks to strike down the ACA.
Even Covered California, the ACA marketplace, has jabbed at the feds. During the most recent enrollment period, which ended in January, it preserved its three-month sign-up window while the federal government cut the enrollment period in half for states that rely on the healthcare.gov exchange. Covered California also deployed a monster advertising budget of $45 million to encourage enrollment, while the federal government slashed its ad dollars to $10 million.
California’s activism could be contagious, said Linda Blumberg, a fellow at the nonprofit research institution the Urban Institute.
“California has been in the forefront” on a lot of health policy issues, she said. To the extent that it is successful, she said, “that helps not only the state of California itself but other states as well.”
Since last year, the federal government has allowed some states to impose work requirements on Medicaid recipients; promoted temporary health plans that have fewer consumer protections than Obamacare insurance; and, most recently, adopted a rule allowing states to lower the percentage of premium dollars that insurers are required to spend on medical care.
“Look at what we’ve done in women’s issues, climate change, protecting immigrants. … That’s just the kind of thing we do. Health is no different,” said state Sen. Ed Hernandez (D-West Covina), the head of the Senate Health Committee and author of several proposals.
Four pending bills in California would provide some consumers with state-funded financial help to supplement federal subsidies created by Obamacare. One such proposal could cost the state about $500 million initially.
“We continue to move forward and push the envelope, now more than ever,” state Sen. Ricardo Lara (D-Bell Gardens) told a room full of physicians recently in Sacramento. Lara, a candidate for state insurance commissioner, is carrying a bill that would offer full Medicaid benefits to a group that’s never been covered before: adults who are in the country illegally.
“We not only play defense, but we want to make sure we’re more proactive,” he said.
California’s efforts to cover unauthorized immigrants under Medi-Cal predate the Trump administration. Achieving it now would represent not only a significant expansion of coverage within the state, but also a direct challenge to the federal government, which has made a point of cracking down on immigrants.
Critics point out that this spirit of defiance does not represent all Californians.
“We have some crazy things happening here,” said Sally Pipes, president of the conservative Pacific Research Institute. “Nobody talks about how to pay for these. Well, you pay for it in increased taxes.”
Sara Rosenbaum, a professor at the Milken Institute School of Public Health at George Washington University, said it’s no secret that President Donald Trump doesn’t like California — and that the feeling is mutual.
While she believes his administration might try to punish the state for its defiance, California will nonetheless persist in its campaign to defend the ACA and expand coverage.
“I’m sure [federal officials] can try to do a million things to make the state’s life miserable,” she said. “They can jerk it around on the federal Medicaid payments. … But I just think this, too, shall pass.”
It’s not clear whether the pending legislative proposals will succeed. Assuming any of the bills make it through the legislature, their fate lies with Gov. Jerry Brown, a Democrat known for fiscal conservatism.
“If the past is any indication, it seems unlikely that bills with sizable and uncertain ongoing costs will move forward,” said Shannon McConville, a researcher at the Public Policy Institute of California.
California is not alone in resisting health care policies put forth by the Trump administration. Other states, including Maryland and New Jersey, may establish state-based penalties for not having insurance — a response to Congress’ decision to kill the federal Obamacare penalty starting in 2019.
But California’s approach, characteristically, is different.
“Rather than use the stick, use the carrot,” said Hernandez. His bill would target $500 million from the state’s general fund to help some income-eligible Californians pay their premiums or out-of-pocket medical costs. This assistance would supplement the federal financial aid for those on the Covered California exchange.
The Senate Health Committee approved the bill last week.
The Congressional Budget Office estimates that about 4 million people nationwide will become uninsured when the tax penalty for not having insurance goes away. In California, the number would be about 378,000, according to a recent Harvard University study.
Three other bills would offer state-based financial aid to different groups of consumers, including those who make too much money to qualify for federal tax credits but still struggle to pay their premiums.
The biggest potential budget-buster of them all is a proposal to establish a single-payer health system, which was pulled from consideration last year, largely because of its eye-popping price tag: $400 billion annually.
Advocates for universal health care aren’t giving up, though some have shifted their strategy to moving piecemeal toward universal health care in lieu of a massive single-payer bill.
“There are individual steps that we can still take to expand coverage to various populations that are falling through the cracks,” said Gerald Kominski, director of the UCLA Center for Health Policy Research.
One of those populations, and a large one, is immigrants living without authorization in the country.
Lara is not the only legislator with a proposal to extend full Medi-Cal coverage to income-eligible adult immigrants without legal status. State Assemblyman Joaquin Arambula (D-Fresno) has introduced a separate bill that would do the same. Arambula’s measure made it through the Assembly Health Committee on Tuesday, and Lara’s bill passed the Senate Health Committee earlier this month.
Of the nearly 3 million Californians without insurance, about 58 percent are currently ineligible for full Medi-Cal benefits or Covered California insurance because they’re not in the country legally.
California must “lead the nation in bold and inclusive polices” that support the health of all communities, said Arambula, who is an emergency room doctor.
In 2016, the state extended full Medi-Cal benefits to all children, and now more than 200,000 undocumented kids are enrolled. It’s not clear how much it would cost to cover undocumented adults, but last year, the state budgeted $279.5 million for the children. Adults are generally more expensive to cover.
All of these measures, successful or not, add up to a campaign of defiance.
“It’s a signal that California is willing to fight very hard, on multiple fronts … to protect certain values and policies,” McConville said. “This shows we’re not willing to go backwards on that.”
In all but a few locations, Medicare's new prevention program isn't up and running yet. And there's no easy way (no phone number or website) to learn where it's available.
Several weeks ago, Medicare launched an initiative to prevent seniors and people with serious disabilities from developing Type 2 diabetes, one of the most common and costly medical conditions in the U.S.
But the April 1 rollout of the Medicare Diabetes Prevention Program, a major new benefit that could help millions of people, is getting off to a rocky start, according to interviews with nearly a dozen experts.
In all but a few locations, experts said, Medicare’s new prevention program — a yearlong series of classes about healthy eating, physical activity and behavioral change for people at high risk of developing diabetes — isn’t up and running yet. And there’s no easy way (no phone number or website) to learn where it’s available.
A Medicare spokesman declined to indicate where the diabetes program is currently available, saying only that officials had approved three providers to date.
In a first for Medicare, community organizations such as YMCAs and senior centers will run the program, not doctors and hospitals. But many sites are struggling with Medicare’s contracting requirements and are hesitant to assume demanding administrative responsibilities, said Brenda Schmidt, acting president of the Council for Diabetes Prevention and chief executive officer of Solera Health, a company that assembles provider networks.
Medicare Advantage plans, an alternative to traditional Medicare run by private insurance companies, are now required to offer the Medicare Diabetes Prevention Program to millions of eligible members. But they aren’t doing active outreach because there are so few program sites available.
It’s “too early” to discuss how Medicare Advantage plans will handle implementation given uncertainty about the program’s accessibility, Cathryn Donaldson, director of communications for America’s Health Insurance Plans, said in an email.
Supporters urge patience. While Medicare’s embrace of diabetes prevention is “transformational,” building an infrastructure of community organizations to deliver these services “hasn’t been done before. It’s going to take time,” said Ann Albright, director of the Division of Diabetes Translation at the U.S. Centers for Disease Control and Prevention.
In a written comment, a spokesman for the Centers for Medicare & Medicaid Services said about 50 of more than 400 eligible programs are in the process of submitting applications. An online resource identifying approved programs is under development, and outreach to people with Medicare coverage is “planned for the coming months,” the statement said.
For those who want more timely information, here’s a look at the Medicare Diabetes Prevention Program and why it’s worth waiting for, even if takes awhile for a program to become available near you.
Diabetes and older adults. According to the CDC, at least 23 million people age 65 and older have “prediabetes” — elevated blood sugar levels that put them at heightened risk of developing Type 2 diabetes.
In five years, without intervention, up to one-third of this group will develop Type 2 diabetes — a leading cause of blindness, amputation and kidney disease in older adults, associated with a heightened risk of heart disease, stroke and dementia.
Program eligibility. The Medicare Diabetes Prevention Program is available to older adults and people with serious disabilities with Medicare Part B coverage who have prediabetes — and it’s free for those who qualify.
Once the program becomes available in your area, your doctor can refer you or you can sign up on your own, so long as you have a body mass index of at least 25 (or a BMI of 23, if you’re Asian), you haven’t been previously diagnosed with diabetes, and your blood sugar levels are consistent with prediabetes.
This benefit is available only once to each qualified Medicare beneficiary, so it behooves you to make sure you’re ready for the commitment it entails.
“The purpose of this should be to improve your health and quality of life, long term, not to lose vanity pounds,” said Marlayna Bollinger, executive director of San Diego’s Skinny Gene Project, which works with people at risk of developing diabetes.
Evidence of effectiveness. Medicare is tweaking the National Diabetes Prevention Program, launched by the CDC in 2010. In a much-cited 2002 study published in the New England Journal of Medicine, researchers found that participants in an early version of the CDC program were 58 percent less likely to develop diabetes than a placebo group. For people 60 and older, the reduced risk of developing diabetes was even more striking — 71 percent.
James Combs, 66, weighed 273 pounds when he enrolled in a program offered by Baptist Health in Lexington, Ky., in January 2016. Today, he weighs 210 pounds, no longer takes medication for high blood pressure, and reported “feeling fantastic.” (Combs enrolled before becoming eligible for Medicare, and his private insurance paid for the program.)
Medicare’s model.Small groups of about eight to 20 people meet weekly, for about an hour, 16 times over a six-month period, then once or twice a month for the next six months. Nutritionists, diabetes educators or other coaches use a structured CDC-approved curriculum and foster group discussion and problem-solving.
Participants check their weight at each session and keep daily logs of what they’re eating and their physical activity. The goal is to have participants lose at least 5 percent of their body weight and get 150 minutes of physical activity weekly.
“The objectives are very realistic and that increases the likelihood of success,” said Kathleen Stanley, Baptist Health’s coordinator for diabetes education and prevention.
A four-year pilot program involving nearly 8,000 seniors in 315 locations, sponsored by Medicare and coordinated by YMCA of the USA, found that savings were significant: an estimated $2,650 over the course of 15 months for each participant.
Medicare has also added a second year of monthly sessions, designed to reinforce lessons learned in the first year, for people who meet weight loss targets and regularly attend classes. (Those who don’t aren’t allowed to attend these sessions.)
Medicare will pay up to $670 per participant for the two-year period if programs meet performance standards relating to weight loss and attendance. If not, payments are lower.
For the moment, Medicare doesn’t plan to work with companies such as Omada Health Inc. or Canary Health that offer online versions of CDC’s Diabetes Prevention Program. But advocacy groups are pressing for this alternative to in-person classes.
“Virtual delivery of the diabetes prevention program would be a great option, particularly for seniors in underserved areas,” said Meghan Riley, vice president of federal government affairs for the American Diabetes Association.
Next steps. YMCA of the USA is among several organizations that plan to participate in the Medicare Diabetes Prevention program but are adopting a cautious approach.
“We’re still digging through Medicare rules and regulations and trying to make sure we understand the implications,” said Heather Hodges, the Y’s senior director of evidence-based health interventions.
She said 25 of the Y’s 840 associations were in the process of applying for Medicare certification and that as many as 50 might be offering the Medicare Diabetes Prevention Program by the end of the year. (Each Y association encompasses multiple locations.)
Albright said the CDC was asking state health departments and 10 national organizations, including the American Diabetes Association, the National Alliance for Hispanic Health and Black Women’s Health Imperative, to promote the new Medicare benefit. Once Medicare publishes a list of programs that its officials have approved, CDC will highlight this online, she said.
Angela Forfia, senior manager of prevention at the American Association of Diabetes Educators, suggested that older adults contact their local Area Agency on Aging, local health departments and senior centers in their area and express interest in the Medicare Diabetes Prevention Program.
“If Medicare recipients start to demand and ask for this, you’ll have more organizations step up and sign on to become Medicare suppliers,” she suggested.
Meanwhile, seniors might want to learn if they have prediabetes. (About 9 out of 10 people who do don’t know it.) “Take our risk test and see where you stand,” Albright advised (available at www.doihaveprediabetes.org). “It’s a good conversation starter with your health care professional, who may want to follow up by ordering a blood test.”
CASTAÑER, Puerto Rico — Helicopters from the power company buzz across the skies of this picturesque valley, ferrying electrical poles on long wires to workers standing on steep hillsides.
The people of Castañer, an isolated village in Puerto Rico’s central mountains, watch warily. Crews have come and gone, and people living along the mountain roads don’t expect to get power until late summer, if ever. Power finally started flowing to the center of town last month, but the electrical grid remains unstable — an island-wide blackout Wednesday disrupted progress — and the hospital continues to use its own generator.
More than six months after Hurricane Maria, daily life in Castañer is nowhere close to normal. Children attend school half the day; another nearby school is closed for at least two years, and families who lost their homes have set up beds and couches in its classrooms.
The deadly storm made landfall on the island’s southeastern coast on Sept. 20 and stayed over the island for nearly eight hours with sustained winds of 155 mph. Across Puerto Rico, it killed as many as a thousand people, wiped away homes and farms and crippled the electrical grid.
The federal government has committed about $18 billion to rebuild Puerto Rico, and in towns like this the task looks immense.
Here in Puerto Rico’s "Coffee Belt," the hurricane winds snapped banana trees and ripped up acres of coffee plants. Flash flooding and mudslides from the heavy rain also wreaked havoc on agricultural crops.
With no harvest this spring, idle men now spend hours on the plaza or in the town bar.
From his office at Castañer General Hospital, Domingo Monroig, the chief executive, looks out onto that bar on Castañer’s main street. In the months since the storm, the hospital has been the town’s organizing center.
"I don’t know if the phrase is unhappy, but we call it como triste in Spanish, because it is not the same," said Monroig.
"For example, when they have light they are playing la cancha [in] the basketball area or they are in the plaza. But if we don’t have light, everybody stays in their home and they say, ‘I don’t know what to do. It’s every day, every day, the same, the same.’"
Many residents here continue to experience acute stress and anxiety attacks, said Dr. Javier Portalatin, a clinical psychologist and director general for mental health at the hospital. "Hurricane Georges was in the nighttime, and we only heard the sounds of it," he said, referring to a devastating 1998 storm that hit the island. "This hurricane, we saw in the daytime in this region. We could actually see what was happening through the windows. I have patients who saw their pets being killed and their neighbors’ houses destroyed right next to them. These memories spur their anxiety attacks."
Up a winding mountain road, one of Portalatin’s patients, Johanna Garcia Mercado, lives in near constant fear. Just 10 feet in front of her tiny, dark home, the hillside collapsed during the hurricane. Since then, she feels panic rising in her chest and often cries uncontrollably.
"When it rains and thunders," said Mercado, "I’m afraid the steep hillside behind the house will collapse and bury my daughters in mud."
The 37-year-old mother lifts up her T-shirt to reveal fresh scars from surgery on her pancreas, caused from the prolonged stress, said her social worker.
Mercado said she has thought of moving, but this piece of land is all the family owns. Her husband worked on the coffee farm across the road, but with no harvest this year, he is digging up yautia roots, which are similar to turnips, and selling them in San Sebastián, an hour away.
The villagers of Castañer are not standing still — they are working hard to recover.
But their resilience is withering, even for people like Mariela Miranda, a devoted do-gooder who has taken it upon herself to bring food and water to her bedridden neighbors. She delivers hot rice and turkey stew to a family that is caring for a 59-year-old man in the final throes of cancer.
They rely on a small inverter to power the ventilator keeping him alive. They have a generator, too, but today it isn’t working.
"It’s been really hard, because they need a generator because his machine has to be on 24 hours for the oxygen," said Miranda.
Miranda gets back in the car and heads to her next stop.
She is a walking catalog of Hurricane Maria’s relentless torment: the neighbor sucking for air because he couldn’t plug in his nebulizer; the diabetics who can’t refrigerate their insulin.
She even helps a 109-year-old bedridden woman with Alzheimer’s who had terrible bedsores after lying for four months on a medical air mattress — not inflated, because her home had no power.
"They’re getting sick mentally," Miranda said. "You can see they’re not the same. You can see the frustration."
Even after the power comes back on, Miranda said, her elderly and bedridden neighbors will never fully recover. "If the light comes back, they will still have the mental damage, like they were like abandoned," she said.
"This gets to you," she continued. "It drains you. You get so frustrated sometimes. Because there are people that will die." She recalls an elderly man she used to visit who died a month ago. "He died because he had [sleep] apnea and he didn’t have the power. So every night he would sleep at the macasina, in the driveway. He would sleep in the driveway sitting on the couch because he was scared to die if he fell asleep."
When asked who should lead the effort to restore daily life to Castañer, Miranda grew exasperated. "We hear the help is getting here," she said, "but those of us who visit the houses? We don’t see it."
At the Mission La Santa Cruz church, the Rev. Edwin Orlando Velez Castro was preparing for Friday night services. Most of the townspeople, he said, were baptized here.
Standing in the darkened chapel — there is no power here either — he said that singing is like a prayer to God to change life and make it new.
"Most of the hymns we sing in this time give people faith that God will help us rebuild ourselves and our town," he said. "That is part of our mission — to be light in this darkness."
When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.
This is an "unequivocally positive" step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.
And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.
Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.
Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.
Many public health advocates applaud the surgeon general’s position.
Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.
"We want to put it more in reach," said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. "It could not have been a better endorsement."
Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a "rational" response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.
"I'm not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina," wrote Goodman, an acute-care nurse practitioner, referring to chest pain.
"What, exactly, are we offering to addicts once their condition has been reversed?" she asked, noting that without treatment and therapy programs that help wean people from addiction "the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby."
Results would likely be limited by naloxone’s price tag.
Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.
But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.
"Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it," Wen said.
The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.
Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.
Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.
Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.
"There’s clearly some overlap" here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.
But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.
Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.
Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.
"Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes," said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. "Ten free kits is not going to be enough."
Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.
But that money is almost dried up. "We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it," Phillips said.
Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.
Pharmacies assess the hurdles of distribution.
Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.
"This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it]," Hitchens said. "A lot were probably saying, ‘What in the devil is naloxone?’"
Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.
Access, though, is always subject to retail pressures.
"If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves," said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.
A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.
That supply stream "meets people where they are," Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.
"Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention," Raymond said.
He’d like to see the federal government step in to negotiate prices where smaller programs can’t.
The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.
In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.
A Senate bill would authorize $300 million annually to equip first responders with naloxone.
But critics say those approaches still don’t address the underlying problems: cost and funding.
"You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it," Wen said. "I don’t care which one. My only concern is the health and well-being of our residents."
The screening, which requires a urine sample, can flag whether a patient is actually taking the prescribed medication and is meant to spark a more truthful conversation between patient and doctor.
There's an irony at the heart of the treatment of high blood pressure. The malady itself often has no symptoms, yet the medicines to treat it — and to prevent a stroke or heart attack later — can make people feel crummy.
"It's not that you don't want to take it, because you know it's going to help you. But it's the getting used to it," said Sharon Fulson, a customer service representative from Nashville, Tenn., who is trying to monitor and control her hypertension.
The daily pills Fulson started taking last year make her feel groggy and nervous. Other people on the drugs report dizziness, nausea and diarrhea, and men, in particular, can have trouble with arousal.
"All of these side effects are worse than the high blood pressure," Fulson said.
Research shows roughly half of patients don't take their high blood pressure medicine as they should, even though heart disease is the leading cause of death in America. For many unfortunate people, their first symptom of high blood pressure is a catastrophic cardiac event. That's why hypertension is called the "silent killer."
A drug test is now available that can flag whether a patient is actually taking the prescribed medication. The screening, which requires a urine sample, is meant to spark a more truthful conversation between patient and doctor.
Fulson's blood pressure has been a moving target, she said. She regularly checks it at home, but it sometimes registers as a little high. Even having it taken in a doctor's office can add enough stress to elevate the results.
This is why taking patients' pressure — the familiar cuff test — doesn't confirm for cardiologists whether patients are consistently taking their hypertension meds. The new drug test, dubbed KardiAssure, uses computers to analyze urine to search for 80 kinds of blood pressure and cholesterol medication, reporting the results in just three minutes.
The test can determine only whether a patient has taken pills in the past day or two. But Aegis Sciences Corp.'s CEO Frank Basile said that's a starting point.
"What we give doctors is a tool that enables them to have a very focused conversation with their patients," he said. Only after the problem is out in the open, he said, can doctors get to the reasons behind it.
The conversation starter has been effective for cardiologist Bryan Doherty in Dickson, Tenn., who has been working with Aegis to test the test. In one case, when the results showed a patient wasn't regularly taking his medicine, though he'd claimed he was, he quickly confessed.
"He immediately turned around and told me that the cost was an issue," Doherty said. "I think there was a degree of embarrassment there, potentially, or a feeling of letting me down in some way — something that had not come up in a 25-minute initial encounter when we had spoken before."
Of course, the test has a cost, too — about $100 — though Doherty noted that insurance, including Medicare, has been covering it.
The conversation is important, Doherty said, because he can try less expensive prescriptions if cost is the issue, or experiment with different kinds of drugs if side effects are the problem. It's worth the potentially uncomfortable encounter with the patient, he said, since the medication might make the difference between life and death.
The screening could also help a patient avoid other unnecessary tests or additional prescriptions, said Dr. Thomas Johnston. He runs the hypertension clinic at Centennial Medical Center in Nashville and is board president of the local chapter of the American Heart Association.
Other than calling the pharmacy to make sure people are refilling their prescription, he said, he generally takes their word for it.
"I think there are a lot of times where you're questioning in your mind whether someone has taken their medicine or not," he said. "I think it would be good for the patient, too, for the doctor to know that they're not taking their medicine so that we may not go down the wrong pathway."
Johnston, who is not affiliated with Aegis, said his only concern about using a drug test would be running the risk of setting up an adversarial relationship with a patient. But there's a way around that, too, he said, by making them understand how vital it is to take the drug properly.
Sarah Avery of Nashville said she's fully aware of the consequences.
"My daddy died because he didn't take his medicine," she said.
Hypertension runs in her family. Her mom and grandmother also battled high blood pressure. Still, the medication is such a drag, she said, that she's decided at times to stop without consulting her doctor.
"I lied. Really, I lied," she admitted. "He said, 'Are you taking your medicine?' I said, 'Mmhmmm. Yeah, my momma makes sure that I do.' I was just lying," she said.
That is, until she, too, had a stroke. Now, she has three blood pressure medications and said she takes them without fail.
States continue to battle budget-busting prices of prescription drugs. But a federal court decision could limit the weapons available to them — underscoring the challenge states face as they, in the absence of federal action, go one-on-one against the powerful drug industry.
The 2-to-1 ruling Friday by the U.S. 4th Circuit Court of Appeals invalidated a Maryland law meant to limit “price-gouging” by makers of generic drugs. The measure was inspired by cases such as that of former Turing Pharmaceutical CEO Martin Shkreli, who raised one generic’s price 5,000 percent after buying the company.
The law, which had been hailed as a model for other states, is one of a number of state initiatives designed to combat rapidly rising drug prices. It gave the state attorney general power to intervene if a generic or off-patent drug’s price increased by 50 percent or more in a single year.
If dissatisfied with the company’s justification, the attorney general could have filed suit in state court. Manufacturers would have faced a fine of up to $10,000 and potentially have to reverse the price hike. The generics industry was fiercely critical of the law.
“We are evaluating all options with regard to next steps,” said Maryland Attorney General Brian Frosh in a statement. His office would not elaborate further.
The state could appeal to have the case heard “en banc,” meaning by the full 4th Circuit, with jurisdiction over five states.
Such appeals aren’t commonly granted, but this law could be a strong candidate, suggested Aaron Kesselheim, an associate professor at Harvard Medical School who researches drug-price regulation.
The Friday ruling looms large as other state legislatures grapple with ever-climbing drug prices.
Similar price-gouging legislation has been introduced in at least 13 states this year, though none of those measures became law, according to the National Conference of State Legislatures (NCSL). Three other bills failed to gain passage.
The NCSL also cited the law in a March advisory for states seeking new approaches to regulating drug prices.
The court’s finding could have a chilling effect on such efforts, especially as more state legislatures wrap up business for 2018.
“A negative court ruling will put a damper or a pause on state activities,” said Richard Cauchi, NCSL’s health program director. “Unless this topic is your No. 1 priority of the year, your legislators are juggling multiple bills, multiple strategies. When bill three gets in trouble, they move to bill four.”
The appeals court held that Maryland’s law overstepped limits on how states can regulate commerce — specifically, a constitutional ban on states controlling business that takes place outside their borders. The majority ruling argues that since most generics manufacturers and drug wholesalers engage in trade outside Maryland, the state cannot control what prices they charge.
In a dissenting opinion, the panel’s third judge argued Maryland can regulate the drug prices charged within the state since the law is meant to affect only medications being sold to its own residents.
Kesselheim, in an article published last month in the journal JAMA, argued a similar point.
Regardless, striking down a law on constitutional grounds can be particularly discouraging, suggested Rachel Sachs, an associate law professor at Washington University in St. Louis who researches drug regulations.
“If it had been a rejection on vagueness grounds, that’s something you can cure with a more specific statute,” she said. “But the fact that they said this is unconstitutional poses real concern for other states.”
That’s important. While the federal government has talked a big game on bringing down drug prices, it has done little. Instead, states have taken the lead — spurred by the budget squeeze pricey prescriptions impose on their Medicaid programs and on state employee benefits packages.
But states have far fewer tools at their disposal than does Congress. Most state laws so far tackle only pieces of the problem — targeting a specific drug or particular practice, experts said.
“We’ll get more broad and better evolution on this issue if the federal government decides to take it seriously — which it hasn’t so far,” Kesselheim said.
To be fair, Maryland’s law is only one of a bevy of approaches.
Other states have focused on price transparency laws. In California, drug companies must disclose in advance if a price might increase by more than a set percent and that they justify the increase. Industry has sued to block the California law.
New York has limited what the state will pay for drugs, establishing a process to review if expensive drugs are priced out of step with their medical value.
A number of states have since 2017 passed laws regulating pharmacy benefit managers — the contractors who negotiate discounted drug coverage for insurance plans, but who rarely reveal what level of discount they actually pass on to consumers.
Experts expect that activity to continue, especially as escalating drug prices show little sign of letting up.
“The states are going to keep trying and experimenting,” Sachs added. “This is a problem that isn’t going away.”
Even efforts such as Maryland’s — which targeted price-gouging — will likely remain at the forefront.
“I don’t think this is the end of states trying to do something on price-gouging,” said Ellen Albritton, a senior policy analyst at the left-leaning advocacy group Families USA who consults with states on drug-pricing policy. “It’s such an issue that offends people’s sensibilities. It’s crazy people can do this.”
Doctors have turned to second-choice pain drugs and increased their use of local anesthetics such as lidocaine. But even those local anesthetics are now in short supply.
Safety violations at a major compounding pharmacy are exacerbating hospital shortages of key painkillers, particularly in California where health officials have taken the “extraordinary” step of prohibiting sales from one of its plants.
In late March, California’s Board of Pharmacy barred the distribution of medications — including lidocaine and other local anesthetics — from a Texas factory belonging to the company, PharMEDium. The decision came after the pharmacy board had issued a cease-and-desist order against the plant in February, citing “an immediate threat to the public health or safety.”
In December, the Food and Drug Administration issued a damning inspection report on PharMEDium’s Tennessee plant that led the company to voluntarily cease production there.
There are two kinds of compounding pharmacies: ones that mix custom prescriptions for individual patients, from chemotherapy cocktails to thyroid drugs, and those like PharMEDium, which mass-produce ready-to-use IV bags, prefilled syringes and other sterile medical solutions for hospitals, surgery centers and other health care facilities.
PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen and supplies medications to about 77 percent of hospitals nationwide.
Before the crackdown on PharMEDium, hospitals already were facing critical shortages of the injectable opioid painkillers Dilaudid, morphine and fentanyl, which started with manufacturing delays at pharmaceutical giant Pfizer. The shutdown at PharMEDium’s Tennessee plant, which makes those drugs, has intensified the shortage nationally.
Doctors, determined to spare their patients pain, consequently have turned to second-choice pain drugs and increased their use of local anesthetics such as lidocaine. But now, even those local anesthetics — lidocaine, ropivacaine and bupivacaine — are in short supply due to manufacturing problems and back orders, according to doctors and federal regulators.
Shortages of both types of painkillers have hit California health care providers especially hard. They must contend with the state crackdown on PharMEDium’s Texas plant, which produces local anesthetics, and federal scrutiny of the Tennessee plant, which produces the injectable opioids. Some California hospitals have abandoned the company altogether.
“We’re having to be very creative,” said Dr. Aimee Moulin, an emergency doctor at the University of California-Davis Health System who is president of the California chapter of the American College of Emergency Physicians.
“There are times when we’re not able to achieve that amount of anesthesia that we would like,” Moulin said. When that happens, she often turns to a second-choice drug that might not be as effective.
Dr. Rita Agarwal, who practices at Stanford University’s Lucile Packard Children’s Hospital, said the facility has a sufficient supply of local anesthetics to cope with the injectable opioid shortages. But if that changes, doctors may have to cancel elective surgeries, she said.
“If we can’t provide patients with adequate pain relief, then it’s sort of barbaric to do the surgery,” said Agarwal, who is also a professor of anesthesiology at Stanford.
In the meantime, her team is using more drugs like Demerol or remifentanil, which are not ideal in many cases because they have side effects or are short-acting.
“It’s unbelievably frustrating,” Agarwal said. “The solutions are [being] snatched away from us.”
California’s concern about PharMEDium dates to at least 2016, when the state warned the company about drugs “lacking in quality or strength” and fined it for failing to notify state officials about a product recall, according to public records obtained by California Healthline.
Then, the California Board of Pharmacy’s temporary cease-and-desist order, issued Feb. 27, faulted PharMEDium’s Sugar Land, Texas, plant for 14 violations, including flawed expiration dating and improper labeling. Virginia Herold, the board’s executive officer, called the action an “extraordinary authority” that it doesn’t use frequently.
In late March, the board decided not to renew the plant’s license. The agency is not aware of any patient harm that may be related to the plant’s failures, Herold said.
PharMEDium spokeswoman Lauren Esposito said the company is committed to resolving the matter.
“We look forward to renewing our California licenses and resuming shipment of our products into the state of California as soon as the board feels that its observations have been satisfactorily addressed,” she said.
California’s crackdown could make waves economically and symbolically, because of the size of its market and the message it sends to other states, said Dave Thomas, a principal with LDT Health Solutions, a consulting firm for compounding pharmacies.
“This can get pretty hairy for PharMEDium pretty fast,” he said.
At the federal level, the FDA’s December report on PharMEDium’s Memphis, Tenn., plant listed a litany of deficiencies.
The report said the plant, which supplies injectable opioids to hospitals around the country, wasn’t doing enough to ensure medications were sterile before shipping them.
The FDA also reprimanded the company for poor employee training and failure to report and thoroughly investigate a case in which a patient became unconscious after receiving an injection of morphine produced by PharMEDium.
In the industry’s defense, said Thomas, the consultant, FDA inspectors can be inconsistent and deficiencies cited at compounding plants can depend on the person writing the report.
Government officials have stepped up scrutiny of compounding pharmacies since 2012, when contaminated drugs from the New England Compounding Center led to a national meningitis outbreak that killed 64 people and sickened 793 patients. The incident led to an eight-year prison sentence for the compounder’s supervising pharmacist, and a 2013 federal law that created new requirements for the pharmacies.
PharMEDium doesn’t know when the Memphis plant will start production again, Esposito said.
“We are actively working to address the items noted by FDA during the inspection and will resume … activities when we have determined our own readiness,” she said.
Because the Memphis plant is still offline, shortages of injectable opioids have worsened, according to a large California medical system.
“It’s been a struggle” to maintain an adequate stock of the medications since the plant stopped producing, said Donald Kaplan, a pharmacy director at Kaiser Permanente in Southern California. (California Healthline is produced by Kaiser Health News, which is not affiliated with Kaiser Permanente.)
Opioid supplies have dwindled so dramatically that Kaiser is shipping medications from one hospital to others that are in short supply, sometimes multiple times per week, he said.
In recent years, some hospitals have sought alternatives to PharMEDium because of quality problems, according to the California Hospital Association.
That’s the case with Mayers Memorial Hospital District in Shasta County, whose chief clinical officer Keith Earnest said it hasn’t used PharMEDium’s products in five years.
“I am glad they are finally no longer allowed to ship to California,” he said. “It has been a long time coming.”