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Must-Reads Of The Week From Brianna Labuskes

April 20, 2018
The Friday Breeze

Newsletter editor Brianna Labuskes, who reads everything on health care to compile our daily Morning Briefing, offers the best and most provocative stories for the weekend.

Welcome back to the Friday Breeze, where I can offer you a break from the Comey memos with a quick look at what you need to know about this week’s health care news.

Some recent abortion laws and legislative proposals in the states seem so strict they’re almost begging for a court challenge. And they are. Activists who think the Supreme Court is one Donald Trump-appointed justice away from overturning Roe v. Wade want to have a legal challenge in the pipeline ready to go. Others in the movement would rather focus on incremental changes, which is getting on the nerves of the more aggressive activists. “They’re standing in the way,” Rep. Steve King (R-Iowa) says in Politico’s story. “I’ve said, ‘Please lead, or get out of the way.’”

• Politico: Abortion Foes Seize On Chance To Overturn Roe

Tying performance and costs is a bit of a Hot Strategy these days, as everyone talks about ways to bring down health care spending. But Italy, which has been trying this approach for more than a decade, serves as a cautionary tale that, at least for drug prices, the efforts don’t really move the needle. Mostly because there’s a wide range of opinions on what exactly “success” looks like.

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And in a look ahead: President Donald Trump is planning a big speech on drug prices next week. But don’t get excited— no new policies are expected to be announced.

• The Wall Street Journal: Italy Serves Cautionary Lesson For New Trump Drug Plan

• Politico: Trump Plans First Major Speech On Drug Prices Next Week

There was a lot of movement on the opioid crisis again this week (nursing homes turning away patients who are recovering from addiction; Sen. Bernie Sanders (I-Vt.) wanting pharma execs to go to jail; and scientists working on a drug that could end addiction). But a deeper recurring theme was how ethics would play into combating the epidemic. What role does the industry that helped create the crisis play in fixing it? Does it matter that advocates who are lobbying for more spending are going to profit from that newly opened congressional wallet? It’s a tricky minefield to navigate.

• Stat: NIH Abruptly Changes Course On Industry Opioids Partnership After Ethics Flags Raised

• Politico: Patrick Kennedy Profits From Opioid-Addiction Firms

Dr. Ronny Jackson, Trump’s nominee for VA secretary, is eager to please, well-liked and ambitious, according to a telling background profile by The Washington Post. But notably absent from the heaping of bipartisan praise were endorsements on his ability to lead the sprawling, troubled agency.

• The Washington Post: ‘He Knows How To Read A Room Really, Really Well’: How White House Physician Ronny L. Jackson Became Trump’s Nominee To Lead VA
Use our content This story can be republished for free (details).

In the miscellaneous file for this week: There’s a disturbing pattern of leniency and forgiveness toward doctors who are accused of sexual assault, and not even the #MeToo movement seems to be changing it; livers like to be kept “warm and happy” instead of put on ice (which led to my favorite lede from the week about how livers are not beers that you pack in a cooler for your camping trip); nefarious profiteers are persuading women to get surgeries they might not need just because that makes them better plaintiffs; and what happens when the teaching hospitals that are supposed to train new doctors instead pass off their bad habits?

• The Associated Press: AP Investigation: #MeToo Has Little Impact On Medical World

• Stat: A ‘Breakthrough In Organ Preservation’ Raises Hopes For Transplants

• The New York Times: How Profiteers Lure Women Into Often-Unneeded Surgery

• Stat: Doctors May Learn Bad Habits At Teaching Hospitals With Safety Violations

And former first lady Barbara Bush’s decision to stop medical treatment and seek comfort care this week stirred a debate over the emotionally charged topic of end-of-life decisions.

Kaiser Health News: Barbara Bush’s End-Of-Life Decision Stirs Debate Over ‘Comfort Care

Have a great weekend, and maybe skip the salad? I know, such a hardship.

And let us know what you think of The Friday Breeze here.

Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging

April 17, 2018

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.

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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.”

Congressional Advisers Urge Medicare Payments To Many Stand-Alone ERs Be Cut

April 17, 2018

The woman arrived at the emergency department gasping for air, her severe emphysema causing such shortness of breath that the physician who examined her put her on a ventilator immediately to help her breathe.

The patient lived across the street from the emergency department in suburban Denver, said Dr. David Friedenson, who cared for her that day a few years ago. The facility wasn’t physically located at a hospital but was affiliated with North Suburban Medical Center several miles away.

Free-standing emergency departments have been cropping up in recent years and now number more than 500, according to the Medicare Payment Advisory Commission (MedPAC), which reports to Congress. Often touted as more convenient, less crowded alternatives to hospitals, they often attract suburban walk-in patients with good insurance whose medical problems are less acute than those who visit an emergency room located in a hospital.

If a recent MedPAC proposal is adopted, however, some providers predict that these free-standing facilities could become scarcer. Propelling the effort are concerns that MedPAC’s payment for services at these facilities is higher than it should be since the patients who visit them are sometimes not as severely injured or ill as those at on-campus facilities.

The proposal would reduce Medicare payment rates by 30 percent for some services at hospital-affiliated free-standing emergency departments that are located within 6 miles of an on-campus hospital emergency department.

“There has been a growth in free-standing emergency departments in urban areas that does not seem to be addressing any particular access need for emergency care,” said James Mathews, executive director of MedPAC. The convenience of a neighborhood emergency department may even induce demand, he said, calling it an “if you build it, they will come” effect.

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Emergency care is more expensive than a visit to a primary care doctor or urgent care center, in part because emergency departments have to be on standby 24/7, with expensive equipment and personnel ready to handle serious car accidents, gunshot wounds and other trauma cases. Even though free-standing emergency departments have lower standby costs than hospital-based facilities, they typically receive the same Medicare rate for emergency services. The Medicare “facility fee” payments, which include some ancillary lab and imaging services but not reimbursement to physicians, are designed to help defray hospitals’ overhead costs.

The proposal would affect only payments for Medicare beneficiaries. But private insurers often consider Medicare payment policies when setting their rules.

According to a MedPAC analysis of five markets — Charlotte, N.C.; Cincinnati; Dallas; Denver; and Jacksonville, Fla. — 75 percent of the free-standing facilities were located within 6 miles of a hospital with an emergency department. The average drive time to the nearest hospital was 10 minutes.

Overall, the number of outpatient emergency department visits by Medicare beneficiaries increased 13.6 percent per capita from 2010 to 2015, compared with a 3.5 percent growth in physician visits, according to MedPAC. (The reported data doesn’t distinguish between conventional and free-standing emergency facility visits.)

“I think [the MedPAC proposal] is a move in the right direction,” said Dr. Renee Hsia, a professor of emergency medicine and health policy at the University of California-San Francisco who has written about free-standing emergency departments. “We have to understand there are limited resources, and the fixed costs for stand-alone EDs are lower.”

Hospital representatives say the proposal could cause some free-standing emergency departments to close their doors.

“We are deeply concerned that MedPAC’s recommendation has the potential to reduce patient access to care, particularly in vulnerable communities, following a year in which hospital EDs responded to record-setting natural disasters and flu infections,” Joanna Hiatt Kim, vice president for payment policy at the American Hospital Association, said in a statement.

Independent free-standing emergency departments that are not affiliated with a hospital would not be affected by the MedPAC proposal. These facilities, which make up about a third of all free-standing emergency facilities, aren’t clinically integrated with a hospital and can’t participate in the Medicare program.

The MedPAC proposal will be included in the group’s report to Congress in June.

Even though stand-alone emergency facilities might not routinely treat patients with serious trauma, they can provide lifesaving care, proponents say.

Friedenson said that for his emphysema patient, avoiding the 15- to 20-minute drive to the main hospital made a critical difference.

“By stopping at our emergency department, I truly think her life was saved,” he said.

Safety Violations Compound Pain Of Painkiller Shortages

April 16, 2018

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.

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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.”

FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research

April 12, 2018

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

KHN Investigation

A researcher’s quest to find a new herpes vaccine raises questions of safety and academic and corporate governance. KHN’s Marisa Taylor investigates.

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The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

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Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations, which has dozens of offices across the country, began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court ruling, a corporate official may be prosecuted for a criminal misdemeanor offense under the Federal Food, Drug and Cosmetic Act even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A GlaxoSmithKline researcher, for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. GlaxoSmithKline later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

Medical Marijuana’s ‘Catch-22’: Federal Limits On Research Hinder Patients’ Relief

April 12, 2018

By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.

For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

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Because the federal government classifies marijuana a Schedule 1 drug — by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

Ann Marie Owen walks with her husband, Bruce, near their home in Port Ewen, N.Y., on Feb. 19. (Allyse Pulliam for KHN)

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.

The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

Ann Marie Owen prepares to take oral medical marijuana at home. The retired university administrative assistant credits marijuana for weaning her off opioids. (Allyse Pulliam for KHN)

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug skyrocketed 250 percent from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

Ann Marie Owen prepares to take oral medical marijuana at home in Port Ewen, N.Y., on Feb. 19, 2018. The retired university administrative assistant credits marijuana for weaning her off opioids. (Allyse Pulliam for KHN)

“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain.

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine

April 10, 2018

Even though the $550 yellow pills sold as Korlym have a controversial origin as the abortion pill, Leslie Edwin says they “gave me life.”

The 40-year-old Georgia resident lives with Cushing’s syndrome, a potentially deadly condition that causes high levels of the hormone cortisol to wreak havoc on a body. When first diagnosed, she said, she gained about 100 pounds, her blood sugars were “out of control,” and she suffered acne, the inability to sleep and constant anxiety.

“I wouldn’t leave the house,” Edwin said of her first bout with the condition. “I quit my job after a certain point. I just couldn’t keep being in front of people.”

That’s when Edwin endured surgeries, including one to remove her pituitary gland. She went into remission, but then, in 2016, her weight shot up 30 pounds and the anxious feelings returned. Her doctors prescribed Korlym.

The drug’s active ingredient is mifepristone, once called RU-486 and better known as the abortion pill because it causes a miscarriage when taken early in a pregnancy. Nearly two decades ago, Danco Laboratories won approval to market Mifeprex in the U.S. as the abortion drug, with tight restrictions on use. Corcept Therapeutics, a Silicon Valley-based drug company, began marketing Korlym six years ago as a specialty drug for about 10,000 rare-disease patients such as Edwin.

The difference in price between Korlym and Mifeprex is striking, even though the ingredients are the same: One 200-milligram pill to prompt an abortion costs about $80. In contrast, a 300-milligram pill prescribed for Cushing’s runs about $550 before discounts. Patients wanting an abortion take only one pill. People with Cushing’s often take up to three pills a day for months or years.

Dr. Joseph Belanoff, chief executive of the drug’s maker, Corcept, said Korlym’s average cost per patient is $180,000 annually and concedes that “we have an expensive drug. There’s no getting around that.”

The story of Korlym highlights how America’s drug development system can turn an old drug into a new one that treats relatively
few — but often very desperate — patients.

When the Food and Drug Administration approved Korlym in 2012, it was designated as an orphan drug, giving Corcept seven years of market exclusivity as well as other economic incentives. Congress approved orphan drug incentives to encourage the development of medicines for rare diseases that affect fewer than 200,000 patients. Since the drug’s approval, Korlym’s price has risen about 150 percent, and last year the company’s revenue nearly doubled to $159.2 million. (Korlym is the company’s only product and treats about 1,000 patients in the U.S.)

“You can hike that drug [price] 50 percent or 80 percent, and if there is backlash you can walk it back,” said Dr. Joshua Liao, an associate medical director at University of Washington Medicine.

Corcept has steadily increased the price with little backlash.

Belanoff said the profits from Korlym pay for the company’s past spending on the drug’s research and development as well as its effort to create new drugs. The company last month reported an encouraging Phase 2 trial update on Korlym’s successor, relacorilant, a drug that could treat Cushing’s without the side effects for some women of endometrial thickening and possible vaginal bleeding.

The company’s pipeline is also full of potential oncology drugs that hold the promise of using molecules to influence the cortisol receptors, with wide-ranging effects in the body. Korlym in combination with another drug is being tested for the treatment of metastatic triple-negative breast cancer, which tends to be more aggressive than other types of breast cancer. And relacorilant is in the very early stages of testing to treat castration-resistant prostate cancer.

While many of the second-generation drugs are not related to Korlym structurally, Korlym did “provide the funding. … If there had not been orphan-drug pricing and the [Orphan Drug] Act, you would have to look for a different way to develop those drugs,” Belanoff said.

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Korlym came to market in 2012 with an average wholesale price of $223.20 per pill before discounts, according to the health care technology firm Connecture. Corcept boosted the price $20 to $50 each year. By December 2017, each pill had an average wholesale price of $549.60 before any discounts or rebates were negotiated for patients.

Alan Leong, senior research analyst and owner of BioWatch, who follows Corcept, said he thought the company might fail at one point but noted that Belanoff “played the odds” with Korlym and won.

So far, incrementally increasing Korlym’s price while adding patients has paid off. Corcept’s stock soared 27.4 percent in January before Teva Pharmaceutical Industries announced it had filed an application for a generic version on the drug. Teva declined to comment for this story.

Belanoff said he would like to know where Teva obtained enough doses of Korlym to successfully test a generic: “We have a single pharmacy and a single manufacturer and the medicine has to be [FedEx’ed] to the patient.”

Talking to analysts last month, Corcept Chief Financial Officer Charlie Robb said the impact of Teva’s generic filing for the next few years is “nothing but litigation, which we can comfortably afford.”

Corcept’s executives expect revenues to keep climbing, reaching $275 million to $300 million in 2018 — an expectation that has not changed despite Teva’s announcement.

A ‘Pioneering Substance’

Cushing’s syndrome happens when the body produces too much of the powerful hormone cortisol, which normally helps keep the cardiovascular system functioning well and allows the body to turn proteins, carbohydrates and fats into energy. But too much cortisol can be destructive. It can cause cognitive difficulties, depression, fatigue, high blood pressure, bone loss and, in some cases, Type 2 diabetes. Those affected by the syndrome can develop a fatty hump between their shoulders and a rounded face. Without treatment, patients can die of a variety of complications, including sepsis after the hormone compromises the immune system.

Mifepristone, the active ingredient in Korlym, helps Cushing’s patients by blocking the body’s ability to process cortisol. It induces an abortion by blocking the body’s receptor for progesterone, which causes the uterine wall to break down.

When the FDA approved Korlym for a specific set of Cushing’s patients, the agency required a “TERMINATION OF PREGNANCY” warning box at the top of the label.

In 2016, Leslie Edwin takes a selfie while vacationing in Cuba. At that time, Edwin was managing her symptoms with daily doses of Korlym. (Courtesy of Leslie Edwin)

In 2012, Leslie Edwin walks down the aisle as a bridesmaid. Edwin says she wasn’t taking medication to treat her Cushing’s syndrome and describes this period as “when things got really bad.” (Courtesy of Leslie Edwin)

Dr. Constantine Stratakis, a senior investigator and scientific director at the National Institute of Child Health and Human Development who specializes in treating people with Cushing’s syndrome, calls mifepristone a “pioneering substance” because it “has a lot of crossover” to other receptors in the body.

That means the drug has a lot of potential uses. Belanoff and Dr. Alan Schatzberg, a Stanford University psychiatrist and scientist, co-founded Corcept in 1998 to explore whether mifepristone could help treat major depression. In 2002, Schatzberg said the drug “may be the equivalent of shock treatments in a pill.”

But clinical trials didn’t back up the claim. Schatzberg rotated off the board and left the company in 2007, saying the company “went in a different direction.” A congressional investigation also questioned whether Schatzberg had conflicts of interest as the government’s principal investigator overseeing clinical trials and a co-founder of Corcept, which had awarded him stock options.

In response to the congressional investigation, Stanford said Schatzberg was fully compliant with its internal conflict-of-interest policy.

Leong of BioWatch recalls the transition to Cushing’s research as a difficult time for Corcept. But after the “psychiatric depression program shut down, [Belanoff] stuck to it,” Leong said.

Social Contract

Corcept’s “Hail Mary” moment came in 2007. The company filed an application to see whether mifepristone might work for Cushing’s patients. (Cushing’s affects about 20,000 people in the U.S., but Corcept executives say the condition often goes undiagnosed.)

Developing the drug cost about $300 million, Belanoff estimates, and involved long-term toxicology tests to ensure that patients could safely take higher doses for months or years. As an orphan drug, a portion of Korlym’s research and development costs could be written off. For example, Corcept reported in 2013 that it had $19.7 million in federal tax credits.

And while Korlym’s annual costs pale against other specialty drugs, which run as high as $750,000 a year, the climbing price tag and increasing number of patients do affect the health care system.

“It’s like an unseen cost and then down the road this is a huge cost burden,” said the University of Washington’s Liao.

Most patients are covered by private insurance, Belanoff said, but Medicare and Medicaid are paying for the drug as well. According to Medicare Part D data, 52 Korlym patients cost Medicare $2.6 million in 2013. Two years later in 2015, 115 beneficiaries filed claims of $11.4 million.

In Georgia, Leslie Edwin is on private insurance and describes herself as being in “a really high tax bracket” yet she never paid more than $25 a month through Corcept’s patient assistance program called SPARK (the Support Program for Access and Reimbursement for Korlym).

“Across the board, it would be very difficult to find any patient that pays the full price,” said Edwin, who volunteers as president of the nonprofit patient advocacy group Cushing’s Support and Research Foundation. The small organization, which reported $50,000 in contributions and grants in 2015, notes on its website that Corcept as well as Novartis Oncology provide financial support to the organization. Edwin is not paid, and the group’s federal tax filing details that the majority of its expenses go to distributing a quarterly newsletter, contacting members and patients “to promote mission,” and providing referrals to doctors.

Belanoff said he believes Corcept has a “social contract” to take care of patients and pledged that any patient who is prescribed Korlym will get it regardless of insurance coverage or costs.

“We were starting with a notorious drug, and the growth has been steady from a very low base over time,” Belanoff said, emphasizing that the “single most important thing” is that the drug works very well.

Dr. Sherwin D’Souza at St. Luke’s Boise Medical Center in Idaho prescribed Korlym for the first time last year to Vonda Huddleston, knowing the company would provide financial assistance until Huddleston could get insurance to pay for surgery.

Huddleston, though, recalled being concerned about the price and what it would cost her out-of-pocket. The company provided her first two months’ worth for free and asked her to call back when she was enrolled for insurance.

“They were so eager to get me on this medication,” she said.

C-SPAN: FDA Commissioner Scott Gottlieb Talks To KHN

April 09, 2018

Kaiser Health News reporter Sarah Jane Tribble sat down with Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, on C-SPAN’s “Newsmakers” program, which aired Sunday. Tribble was joined by Bloomberg correspondent Anna Edney. The conversation ranged from how the nation should combat the opioid epidemic to reining in drug prices. Gottlieb said competition in the drug market remains key to lowering prices.

A Tale Of Two CT Scanners — One Richer, One Poorer

April 09, 2018

Benjamin Hynden, a financial adviser in Fort Myers, Fla., hadn’t been feeling well for a few weeks last fall. He’d had pain and discomfort in his abdomen.

In October, he finally made an appointment to see his doctor about it. “It wasn’t severe,” he said. “It was just kind of bothersome. It just kind of annoyed me during the day.”

The internist, Dr. John Ardesia, checked him out and referred him for a CT scan at a nearby imaging center. The radiologist didn’t see anything wrong on the images, and Ardesia didn’t recommend any treatment.

A few weeks later, Hynden, who has a high-deductible health insurance policy with Cigna, got a bill for $268. He paid it and moved on.

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But three months later, in mid-January, Hynden was still feeling lousy. He called up Ardesia’s office again. This time, the doctor wasn’t available. A nurse practitioner, concerned that Hynden might be suffering from appendicitis, advised him to go to the hospital right away.

“I was a little worried,” Hynden recalled. “When he told me to go to the ER, I felt compelled to take his advice.”

Hynden arrived later that morning at Gulf Coast Medical Center, one of several hospitals owned by Lee Health in the Fort Myers area. The triage nurse told him the problem wasn’t his appendix, but she suggested he stick around for some additional tests — including another CT scan — just to be safe.

“It was the exact same machine. It was the exact same test,” Hynden said.

The results were also the same as the October scan: Hynden was sent home without a definitive diagnosis.

And then the bill came.

Patient: Benjamin Hynden, 29, a financial adviser in Fort Myers, Fla.

Total Bill: $10,174.75, including $8,897 for a CT scan of the abdomen

Service Provider: Gulf Coast Medical Center, owned by Lee Health, the dominant health care system in southwest Florida.

(Story continues below.)

Medical Procedure: A computed tomography scan, commonly known as a CT or CAT scan, uses X-rays to create cross-sectional images of the body. Hynden got his October scan at Summerlin Imaging Center, a standalone facility in Fort Myers that offers a range of diagnostic tests, including X-rays, MRI and CT scans.

Rick Davis, co-owner of Summerlin, said his center is small and independent, so he doesn’t have much bargaining power. That means insurance companies pretty much dictate what he can charge for a scan. In Hynden’s case that was $268, including the cost of a radiologist to read the images.

Ultimately, what Medicare decides to pay for a scan sets the standard. “The Medicare fee schedule is what all the other companies use as their guideline,” Davis said. “It’s basically the bible. It’s what everyone goes by.”

Benjamin Hynden was surprised when he received a bill for a CT scan that was 33 times higher than a scan he received months before at an imaging clinic. (Alison Kodjak/NPR)

Summerlin’s office manager, Kimberly Papiska, said that the maximum the center ever bills for a CT scan is $1,200, but that the rates insurance companies pay are usually less than $300.

Hynden was shocked when he got the second CT scan in January, and the listed price was $8,897 — 33 times what he paid for the first test.

Gulf Coast Medical Center is part of his Cigna insurance plan’s approved network of providers. But even with Cigna’s negotiated discount, Hynden was on the hook for $3,394.49 for the scan. The additional ER costs added another $261.76 to that bill.

What Gives: We called Gulf Coast Medical Center and its parent company, Lee Health, to understand why they billed nearly $9,000 for a single test. No one at the health center or hospital would agree to an interview.

Lee Health spokeswoman Mary Briggs responded with an emailed statement: “Generally that it is not unusual for the cost of providing a CT scan in an emergency department to be higher than in an imaging center. Emergency department charges reflect the high cost of maintaining the staffing, medical expertise, equipment, and infrastructure, on a 24/7-basis, necessary for any possible health care need — from a minor injury to a gunshot wound or heart attack to a mass casualty event.”

Do the hospital’s costs and preparations justify a list price that’s so much higher than the nearby imaging center’s tab? We asked some experts in medical billing and management for their thoughts.

Emergency rooms often charge people with insurance a lot of money to make up for the free care they provide to uninsured patients, said Bunny Ellerin, director of the Healthcare and Pharmaceutical Management program at Columbia Business School in New York. “Often those people are what they call in the lingo ‘frequent flyers,'” Ellerin said. “They come back over and over again.”

She said hospitals also try to get as much money as they can out of private insurance companies to offset lower reimbursements from Medicare and Medicaid.

Even in that context, the price of Hynden’s CT scan was off the charts.

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Healthcare Bluebook, a health care pricing tool, says the range for an abdominal CT scan with contrast, like Hynden had, in Fort Myers is between $477 and about $3,700. It pegs a fair price at $595.

The higher price from Gulf Coast Medical Center and its parent company could be a result of their enormous pricing power in Fort Myers, said Gerard Anderson, a professor of health policy and management at Johns Hopkins University.

Lee Health owns the four major hospitals in the Fort Myers area, as well as a children’s hospital and a rehabilitation hospital, according to its website. It also owns several physician practices in the area. When you drive around Fort Myers, the blue-green Lee Health logo appears on buildings everywhere.

“Anybody who’s in Fort Myers is going to want to get care at these hospitals. So by having a dominant position, they have great bargaining power,” Anderson said. “So they can raise their rates, and they still do OK.”

Anderson said his research shows hospital consolidation has been driving prices higher and higher in recent years. And because more and more people, like Hynden, have high-deductible insurance plans, they’re more likely to be on the hook for huge bills.

So Lee Health and other dominant hospital systems mark up most of their services on their master price lists — the list that prices a CT scan at Lee Health at $8,897. Anderson calls those lists “fairy-tale prices” because almost no one actually pays them.

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“Everybody who’s taken a look at it agrees — including the CFO of the organization — that it’s a fairy-tale thing, but it does have relevance,” Anderson said.

The relevance is that insurance companies typically negotiate what they’ll pay at discounted rates from list prices.

So from the master price of $8,897, Cigna negotiated Hynden’s bill down to $5,516.14 — a discount of almost 40 percent. Then Cigna paid $2,864.08, leaving Hynden to pay the rest.

“If it wasn’t for that CT scan, I don’t think this whole thing would have been so difficult and so blatantly obvious that they’re extremely overcharging for that service,” Hynden said.

Resolution: Hynden never got a definitive diagnosis from the CT scans. Several weeks after his second test, however, he went to a nearby urgent care center, also run by Lee Health, and underwent an ultrasound on his abdomen. That test, which cost about $175, revealed some benign cysts that he said his doctor said are likely to go away on their own.

The Takeaway: Tests and services are almost always going to be more expensive in an emergency room or hospital setting. If your doctor suggests you go to an ER, it might be worth asking whether an urgent care or walk-in clinic would suffice.

Sources: Explanations of Benefits provided by Benjamin Hynden and interviews.

This is a monthly feature from Kaiser Health News and NPR that will dissect and explain real medical bills in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. Do you have a medical bill that you’d like us to see and scrutinize? Submit it here and tell us the story behind it.

Dialysis Patients Sign Up For November Ballot Fight

April 06, 2018

LOS ANGELES — Tangi Foster raised her left arm to show two puncture wounds where nurses insert needles several times a week.

She’s been on dialysis for 10 years and has received treatment at several different centers. She left the first because she saw roaches. At others, she often spied blood stains and cookie crumbs on chairs and on the ground, she said.

“Infections are a great concern for people with wounds,” said Foster, 60, a Northridge, Calif., resident who addressed a lively crowd outside the First African Methodist Episcopal Church Thursday.

About 60 people had gathered on the front lawn of the church to rally against what they consider unsafe and unsanitary conditions at many dialysis clinics.

Foster, who is tall, thin and strong-willed, has become a leading voice in a movement that is demanding dialysis clinics improve patient care.

Tangi Foster of Northridge has been a dialysis patient for 10 years. She says she has seen cockroaches and blood stains on the ground of dialysis centers and worries about infections. (Ana B. Ibarra/California Healthline)

Dialysis treatment, also known as hemodialysis, filters impurities from the blood, and people with end-stage kidney disease need it to stay alive. DaVita Kidney Care and Fresenius Medical Care are the industry giants.

Dialysis is a very dangerous procedure, Foster said: “They are literally taking all the blood out of your body, anything could go wrong.”

Roughly 66,000 Californians with kidney failure rely on dialysis, according to the U.S. Renal Data System.

Backed by the powerful Service Employees International Union–United Healthcare Workers West, Foster and others are turning to the ballot box in an attempt to meet their demands. After they rallied in Los Angeles and three other California cities Thursday, they delivered more than 600,000 signatures to election offices around the state.

They need about 60 percent of those signatures to be verified in order to get a proposal on the Nov. 6 ballot. The measure would limit dialysis companies’ revenues to 15 percent above what they spend on patient care. If their revenues exceeded that threshold, the companies would have to refund the difference to insurers or patients.

The research looks at the effect when new untrained residents start working at hospitals. Also in the news, research exploring disparities in nursing home risk scores.

Supporters of the proposal are banking on the idea that companies like DaVita and Fresenius would rather provide more care than give money back to insurance companies. Neither company would comment on the matter.

At Thursday’s rally, patients and their loved ones loaded a dozen boxes stuffed with signed petitions onto a van headed for the Los Angeles County Registrar of Voters. Onlookers — some standing, others in wheelchairs — clapped and cheered.

Some carried photos of deceased parents and family members who were once dialysis patients.

Cecilia Gomez-Gonzalez of El Monte says both her parents were dialysis patients. She supports The Fair Pricing for Dialysis Act because after spending years with them in dialysis centers, she saw “tragic things happen.” (Ana B. Ibarra/California Healthline)

One of the church’s pastors, Edgar Boyd, told the crowd that many people in his congregation and community are on dialysis, including his brother.

“This hits home,” he said. “We are asking them to do what is right, to do what is fair.”

Opponents of the measure say that putting a cap on how much revenue clinics can keep might backfire: Clinics, especially ones run by nonprofits, could end up struggling to cover their operating costs.

Miguel Estrada, a technician who monitors patients in a DaVita clinic in San Rafael, Calif., believes that the measure would force clinics to reduce care for patients and possibly shut down. Estrada belongs to a group called Patients and Caregivers to Protect Dialysis Patients, a coalition opposing the measure that is funded by the industry.

He said the clinics where he’s worked have not been dirty and unsanitary.

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Debbie Coote, another technician, also thinks dialysis patients will suffer if the ballot measure is approved. “If they reduce how much is being reimbursed, how are they going to afford to hire more people and buy new machines?” she said.

One dialysis nurse who attended the rally said she’s fed up with clinic conditions. Ida Deperio, who works at a DaVita clinic in Montebello and a Fresenius clinic in West Covina, said both sites are severely understaffed.

Ideally, you would assign no more than four patients to each technician, explained Deperio, 59, who came to the rally in her scrubs. Yet in some cases, technicians have to monitor nearly a dozen patients at a time, she said.

“That’s crazy,” Deperio said, noting that a higher patient load increases the chance of errors. “I’m scared for my patients and for my license.”

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

April 06, 2018
Explore The Database

Pre$cription For Power

3:57 AM EDT

Investigating the relationships between patient advocacy groups and Big Pharma

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

This story also ran on Daily Beast. This story can be republished for free (details). “When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

There aren’t a lot of large pockets of funding outside of the pharmaceutical money. We take it where we can find it.

Lorren Sandt, Caring Ambassadors Program

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

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What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

It’s clear that more transparency in this space is vitally important.

Sen. Claire McCaskill (D-Mo.)

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity As Marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie — whose specialty drug Humira made up 65 percent of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis — gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

(Story continues below.)

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie — which overall donated $24.7 million to patient groups in 2015, according to the new database — stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin And Influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3 percent of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years — up to four times per product — leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its bestselling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests — by people demanding to know the cost of manufacturing a vial of insulin — at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” — manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Sick consumers make for good press.

Dr. Adriane Fugh-Berman, PharmedOut

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching Into The Future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug — aimed at a subset of people with Duchenne muscular dystrophy — were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program — 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta Therapeutics is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined — Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals and Vertex Pharmaceuticals — declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Fugh-Berman said.

And in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

To learn how Kaiser Health News created the Pre$cription for Power database, read the full methodology, here.

California Takes On Health Giant Over High Costs

April 01, 2018

California’s attorney general sued Sutter Health, accusing the hospital giant of illegally quashing competition and for years overcharging consumers and employers.

The lawsuit marked a bold move by state Attorney General Xavier Becerra against the dominant health care system in Northern California as concerns mount nationally about consolidation among hospitals, insurers and other industry middlemen.

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“It’s time to hold health care corporations accountable,” Becerra said at a news conference Friday. “We seek to stop Sutter from continuing this illegal conduct.”

The antitrust suit, filed in San Francisco County Superior Court, asks the court to prevent Sutter from engaging in anticompetitive practices and “overcharges.”

It said Sutter employs a variety of improper tactics, such as gag clauses on prices, “punitively high” out-of-network charges and “all-or-nothing” contract terms that require all of its facilities to be included in insurance networks.

Taken together, Sutter’s actions “improperly block any and all practical efforts to foster or encourage price competition between Sutter and any rival Healthcare Providers or Hospital Systems,” according to the state’s complaint. “Sutter’s conduct injured the general economy of Northern California and thus of the state.”

Sutter, which owns 24 hospitals, reported net income of $893 million last year on $12.4 billion in revenue. Sutter’s nonprofit health system also has 35 surgery centers, 32 urgent-care clinics and more than 5,000 physicians in its network.

In a statement Friday, Sutter said it had not yet seen the state’s complaint and couldn’t comment on specific claims.

Overall, Sutter said, “healthy competition and choice exists across Northern California” for consumers seeking medical care. It also said its charges for an inpatient stay are lower than what other nearby hospitals charge.

“Sutter Health is proud to save patients, government payers and health plans hundreds of millions of dollars each year by providing more efficient and integrated care,” the statement said.

This high-profile legal fight caught the attention of employers and policymakers across the country amid growing alarm about the financial implications of industry consolidation. Large health systems are gaining market clout and the ability to raise prices by acquiring more hospitals, outpatient surgery centers and physicians’ practices.

Martin Gaynor, a health care economist at Carnegie Mellon University, said California’s lawsuit may portend more litigation at the state level.

“There are a number of markets in the U.S. that are dominated by one very large, powerful health system,” Gaynor said. “It could be that we’re going to see a new level of activity by state antitrust enforcers looking at competition in their own backyards.”

Glenn Melnick, an economist and expert on hospital finances at the University of Southern California, said if the state prevails against Sutter it could put “a chill on anticompetitive practices that are being adopted across the U.S. and that could help slow down hospital price increases. That would be good news for consumers.”

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The complaints about Sutter’s high prices and market power have persisted for years.

The state said its investigation started in 2012 under Kamala Harris, California’s previous attorney general and now a U.S. senator. Six years ago, her office sent subpoenas to several health systems and insurers seeking information about market concentration and its effect on medical prices.

A 2016 study found that hospital prices at Sutter and Dignity Health, the two biggest hospital chains in California, were 25 percent higher than at other hospitals around the state. Researchers at the University of Southern California said the giant health systems used their market power to drive up prices — making the average patient admission at both chains nearly $4,000 more expensive.

This week, researchers at University of California-Berkeley issued a report that examined the consolidation of the hospital, physician and health insurance markets in California from 2010 to 2016. The authors said 44 of California’s 58 counties had “highly concentrated” hospital markets.

The problem is worse in Northern California, and the report said prices for medical procedures are often up to 30 percent higher there than in Southern California, which has more competition.

“Consumers are paying more for health care as a result of market consolidation. It is now time for regulators and legislators to take action,” according to the report by the Petris Center on Health Care Markets and Consumer Welfare at UC-Berkeley.

After the report was issued Monday, Becerra said his office would be reviewing those findings and pledged to apply more scrutiny to health care mergers and anticompetitive practices across the state.

Sutter Health has gobbled up doctors’ practices across the Bay Area, gaining market muscle that has pushed costs upward. Obstetricians employed by Sutter Health, for example, are reimbursed about three times more for the same service than independent doctors, according to a KHN review of OB-GYN charges on several insurers’ online cost estimators. It’s a key reason why Northern California is the most expensive place in the country to have a baby.

At his news conference, Becerra said he’s committed to scrutinizing other players besides Sutter in the health care industry who may be engaging in anticompetitive behavior and potentially harming consumers.

“We hope what we do with this case sends a signal — watch what you do and obey the law,” Becerra said.

Consumer advocates and state lawmakers applauded Becerra’s aggressive action because of the toll high prices take on millions of Californians. Many residents struggle to pay rising insurance premiums and out-of-pocket expenses for emergency room visits or routine hospital tests.

“Consumers bear the burden of these monopolistic activities,” said state Sen. Ed Hernandez (D-West Covina), chairman of the Senate health committee. “To ensure health care is affordable and accessible to all, we have to get a handle on predatory pricing.”

In many ways, Becerra’s lawsuit mirrors a similar civil case filed in 2014 by a grocery workers’ health plan.

“It’s time to hold health care corporations accountable,” California Attorney General Xavier Becerra said at a news conference Friday. (Ana B. Ibarra/California Healthline)

The plaintiffs in that case allege Sutter is violating antitrust and fair competition laws. The plaintiffs have been requesting documents related to contracting practices, such as “gag clauses” that prevent patients from seeking negotiated rates and choosing a cheaper provider. They also are challenging “all-or-nothing” terms that require every facility in a health system to be included in insurance networks.

In November, the state judge handling the grocery workers’ case said Sutter was “grossly reckless” when it intentionally destroyed 192 boxes of documents that employers and labor unions were seeking in the lawsuit. San Francisco County Superior Court Judge Curtis E.A. Karnow said Sutter destroyed documents “knowing that the evidence was relevant to antitrust issues. … There is no good explanation for the specific and unusual destruction here.”

The lead plaintiffs, the United Food and Commercial Workers and its Employers Benefit Trust, are a joint employer-union health plan that represents more than 60,000 employees, dependents and retirees. The court certified its case as a class action in August, allowing hundreds of other employers and self-funded health plans to potentially benefit from the litigation.

The attorney general’s office filed a motion in court asking for its lawsuit and the class action to go to trial together before the same judge. The trial is scheduled for June 2019 in San Francisco.

“While we certainly would have preferred this happened earlier, we respect the attorney general’s care in conducting a thorough investigation before filing charges,” said Richard Grossman, the lead plaintiffs’ lawyer representing the class of more than 1,500 employer-funded health plans. “This lends additional credibility to the allegations we made in our complaint four years ago.”

In its lawsuit, the attorney general’s office blamed Sutter for much of the increase in health care costs across Northern California because “Sutter embarked on an intentional, and successful, strategy of securing market power in certain local markets.” State lawyers also pointed out that Sutter’s conduct triggered an “umbrella effect” by encouraging other providers to  raise their own prices.

The state’s lawsuit said Sutter used its windfall from excessive prices to acquire more hospitals and medical groups. It also enabled Sutter to “bestow extremely high salaries for its officers and upper management,” according to the state complaint.

Patrick Fry, Sutter’s chief executive from 2005 to 2016, had $13.4 million in total compensation during his last year there, according to Sutter’s 990 tax filing for 2016, the most recent year available.

Overall, 18 executives at Sutter had $1 million or more in total compensation during 2016, the federal tax filing shows.

Karen Garner, a Sutter spokeswoman, said Fry’s compensation in 2016 reflects retirement benefits he accrued over many years. She added that “industry comparisons show our salaries are reasonable and competitive, given the size, scope and complexity of our organization.”

KHN senior correspondent Jenny Gold contributed to this report.

Readers Seek Transparency On Surgery Centers, ‘Bill Of The Month’ Investigations

March 28, 2018

Letters to the Editor is a periodic Kaiser Health News feature. KHN welcomes all comments and will publish a selection. We edit for length and clarity and require full names.

Surgery Centers: The Bigger Picture

Here is my response—as a #journalist and #anesthesiologist–to the @KHNews/@USATODAY report on #surgerycenters. ANY death is horrific. But context matters–and makes for stronger #reporting. @ASCAssociation @By_CJewett @markalesia

— Dr. James Lozada (@DrJLozada) March 2, 2018

Surgery and anesthesia carry with them small but known risks, including death. The thrust of the story was that ASCs are more dangerous than hospitals. However, the data as we currently know it do not support that claim. It’s possible that better reporting of adverse events from ASCs will provide new information. And I fully support the push for more information. Still, contextual reporting is important.

— Dr. James Lozada, Chicago

Last year, more than 20 million Americans put their trust in ambulatory surgery centers (ASCs) for outpatient surgical procedures and treatments ranging from cataract surgery to total joint replacement. They did so because the surgeons, nurses and other health professionals who practice in ASCs have the same education, training and talent as their peers who work only in hospitals.

Regrettably, the Kaiser Health News-USA Today Network article “As Surgery Centers Boom, Patients Are Paying With Their Lives” (March 2) by Christina Jewett and Mark Alesia focused on a relatively small number of adverse events, while ignoring the more than 100 million successful procedures that ASCs provided during the same time frame.

Despite the innuendo and conjecture in this article, there is no empirical evidence that supports the inference that surgery centers pose risk to patients. The adverse events highlighted in the story were tragic anomalies.

Here are a few other essential facts about ASCs that the story does not cover:

Hospital Transfers. ASCs, like hospital outpatient departments, have all the medical equipment and training needed to respond to unanticipated emergencies. In rare instances, a hospital transfer becomes necessary, and surgery centers work with their local hospitals to have protocols in place to provide for those. More importantly, a recent study in the January issue of the Journal of Health Economics concluded: “We find that patients treated in an ASC are less likely to be admitted to a hospital or visit an emergency room a short time after outpatient surgery.”

Regulatory Approval For Outpatient Surgery. ASCs are an integral part of an extremely risk-averse health care system in this country. As such, new procedures move into the ASC setting only after the medical community is convinced that the surgical technique, anesthesia, pain control and recovery time associated with these outpatient procedures support the same outcomes as when those procedures are performed in the hospital.

Transparency. ASCs have long supported meaningful health care quality reporting across all sites of service and continue to work for improvements in these systems to help patients make informed decisions. Patients deserve better access to data on the safety, quality and cost of the care they are to receive, regardless of where they go for the procedure.

Cost Savings. ASCs also have a superior record of providing real value to patients, since the payments for procedures performed in surgery centers are typically much lower than the same procedures performed in hospital outpatient departments. For Medicare beneficiaries, as an example, ASC fees are approximately 50 percent of those that hospital outpatient departments receive. A review of commercial claims data found that U.S. health care costs are reduced by more than $38 billion per year due to the availability of ASCs as an appropriate setting for care. More than $5 billion of those savings benefit patients through lower deductible and coinsurance payments.

The stories these reporters told were, indeed, tragic, and will no doubt be deeply concerning to your readers. As health care professionals dedicated to helping patients, the doctors, nurses and other health professionals in ASCs share in the loss and regret that accompanies any adverse medical event. But we also know these events are both rare and occur across all sites of care, including hospitals.

While serious adverse events are rare in every setting, they are even rarer in ASCs because the model of care is based on using each patient’s health history to ensure that they can be seen safely as an outpatient. Patients considering surgery should talk to their doctors about their health, ask questions and do their own research on the sites of care available to them. When they do, we are confident that, for most patients, the facts will lead them to the conclusion that an ASC is the right choice for the outpatient surgical care they need.

— William Prentice, CEO of the Ambulatory Surgery Center Association, Alexandria, Va.

My father was one of those patients… the gastroenterologist who botched his colonoscopy causing his death the next day was also part-owner of the Surgery Center where the colonscopy was performed…it was like a cattle call…get em in & get em out

Without Context Or Cushion, Do Online Medical Results Make Sense?

March 27, 2018

As she herded her two young sons into bed one evening late last December, Laura Devitt flipped through her phone to check on the routine blood tests that had been performed as part of her annual physical. She logged onto the patient portal link on her electronic medical record, scanned the results and felt her stomach clench with fear.

Devitt’s white blood cell count and several other tests were flagged as abnormal. Beyond the raw numbers, there was no explanation.

“I got really tense and concerned,” said Devitt, 39, a manager of data analysis who lives in New Orleans. She immediately began searching online and discovered that possible causes ranged from a trivial infection to cancer.

“I was able to calm myself down,” said Devitt, who waited anxiously for her doctor to call. Two days later, after hearing nothing, she called the office. Her doctor telephoned the next day. She reassured Devitt that the probable cause was her 5-year-old’s recent case of pinkeye and advised her to get tested again. She did, and the results were normal.

“I think getting [test results] online is great,” said Devitt, who says she wishes she had been spared days of needless worry waiting for her doctor’s explanation. “But if it’s concerning, there should be some sort of note from a doctor.”

Devitt’s experience illustrates both the promise and the perils of a largely unexamined transformation in the way growing numbers of Americans receive sensitive — sometimes life-changing — medical information. A decade ago, most patients were informed over the phone or in person by the doctor who had ordered testing and could explain the results.

But in the past few years, hospitals and medical practices have urged patients to sign up for portals, which allow them rapid, round-the-clock access to their records. Lab tests (with few exceptions) are now released directly to patients. Studies estimate that between 15 and 30 percent of patients use portals.

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The push for portals has been fueled by several factors: the widespread embrace of technology, incentive payments to medical practices and hospitals that were part of 2009 federal legislation to encourage “meaningful use” of electronic records, and a 2014 federal rule giving patients direct access to their results. Policymakers have long regarded electronic medical records as a way to foster patient engagement and improve patient safety. Studies have found that between 8 and 26 percent of abnormal lab results were not communicated to patients promptly.

Are portals delivering on their promise to engage patients? Or are these results too often a source of confusion and alarm for patients and the cause of more work for doctors because information is provided without adequate — or sometimes any — guidance?

Releasing results on portals remains “an answer with many questions,” said Hardeep Singh, a patient safety researcher at the Michael E. DeBakey VA Medical Center in Houston. “There is just not enough information about how it should be done right,” said Singh, who is also an associate professor at Baylor College of Medicine and one of the few researchers to study patients’ experiences obtaining test results from portals. “There are unintended consequences for not thinking it through.”

Although what patients see online and how quickly they see it differs — sometimes even within the same hospital system — most portals contain lab tests, imaging studies, pathology reports and less frequently, doctors’ notes. It is not uncommon for a test result to be posted before the doctor has seen it.

That means that a patient may be the first to learn of a suspicious breast mass, a recurrence of cancer or possible kidney failure. At Johns Hopkins medical system in Baltimore, for example, results of a PSA test to screen for prostate cancer come with this disclaimer: “While Johns Hopkins providers check results frequently, you may see results before your provider has seen them.”

Breast cancer specialist Lidia Schapira is an associate professor at the Stanford University Medical Center and editor-in-chief of, the patient information website of the American Society of Clinical Oncology. While she regards online access as beneficial, “the danger is that the patient may learn information they’re unprepared to receive and may feel abandoned if they can’t reach their doctor.”

“Those are the Friday afternoon phone calls,” she said, when “at 4:59 [p.m.] a patient has accessed the results of a scan and the doctor signs out at 5.” The recipient of the anguished inquiry that follows is typically a covering doctor who doesn’t know the patient or details of the case.

When Is Use Meaningful?

A recent study by Singh and his colleagues found that, like Devitt, nearly two-thirds of 95 patients who obtained test results via a portal received no explanatory information about the findings. As a result, nearly half conducted online searches. Many with abnormal results called their doctors.

That echoes a 2016 study led by researchers from the University of Pittsburgh. These scientists found that in addition to engaging patients, portal use may increase anxiety and lead to more doctor visits.

Among patients with low health literacy and numerical skills, confusion about the meaning of results is common. Many tests are reported in the same form that the doctor sees them, which even savvy patients may find “literally meaningless,” observed Brian Zikmund-Fisher, an associate professor in the school of public health at the University of Michigan.

“In some situations we run the risk of patients misinterpreting that there is no problem when there is one, or assuming there’s a problem when there isn’t,” said Zikmund-Fisher, lead author of a study that advocates the use of explanatory graphics to convey results. “What we need to be focusing on is giving patients context.”

A year or so ago, Geisinger Health System in Pennsylvania began making most test results — but not biopsies or HIV screening — available to patients within four hours of being finalized.

“We essentially release results twice a day seven days a week with a four-hour lag,” said Ben Hohmuth, Geisinger’s associate chief medical informatics officer. The delay, he said, gives doctors time to review results. Patients who log on over a weekend can contact an on-call physician if they can’t reach their own doctor. The goal of rapid release, Hohmuth said, is to “be patient-centered and transparent.”

“The majority [of patients] want early access to their results, and they don’t want it to be impeded” while waiting for doctors to contact them, Hohmuth said, even if the news is bad.

Patient reaction, he adds, has been “overwhelmingly positive”; the few complaints have come from physicians.

Health lawyer Kathleen Kenyon said she would have appreciated faster access to blood test results for her elderly mother, who had multiple medical problems including Alzheimer’s disease. Kenyon, who managed and closely monitored her mother’s condition, said she believes speedier access could have helped stave off a four-day hospitalization in the intensive care unit of a Washington hospital caused by her mother’s plummeting sodium level.

“It is safer for patients to have more information,” said Kenyon, formerly a senior policy analyst at the Department of Health and Human Services. “I was begging them to get my mother’s lab information in earlier.”

What Does This Mean?

At 46, writer Rebecca Esparza has survived Stage 4 ovarian cancer as well as thyroid cancer. She normally loves having round-the-clock access to her records and the ability to email her doctors.

But in 2016, immediately after extensive abdominal surgery at a hospital several hours from her home in Corpus Christi, Texas, doctors told her they suspected she had developed colon cancer. Confirmation would require further evaluation by a pathologist.

Esparza went home and waited, checking her portal repeatedly. A week later, she logged on to find a highly technical biopsy report she could not understand. A friend who is a nurse read it and told Esparza there was no mention of a malignancy. Two weeks after Esparaza left the hospital and a week after the report appeared on her portal, one of her doctors confirmed that she didn’t have cancer after all.

“It was really traumatic and the one time I wish I hadn’t had access,” said Esparza, an advocate for the National Coalition for Cancer Survivorship.

Although Esparza considers her experience to be “a fluke,” she notes similar confusion among other cancer patients in the online support groups she runs.

“People post their blood test and other results all the time and ask what it means,” she said. Esparza said she intercedes by reminding participants “we’re not doctors.”

One way for a physician to provide guidance, said Stanford’s Schapira, is for doctors to negotiate with patients in advance, particularly if they are concerned the news might be bad.

It is a strategy she employed at her previous job at Massachusetts General Hospital in Boston. “I would say, ‘Let’s do a scan and then schedule a visit two days later, and we can discuss the results,'” she said.

One Doctor’s Experience

Mass General internist Katharine Treadway knows what it’s like to obtain shocking news from an electronic medical record. The experience, she said, has influenced the way she practices.

More than a decade ago — long before most patients had portals — Treadway, with her husband’s permission, pulled up the results of his MRI scan on a hospital computer while waiting to see the specialist treating his sudden, searing arm pain.

“It showed a massive tumor” and widespread metastatic disease, Treadway recalled. She never suspected that her 59-year-old husband had cancer, let alone a highly aggressive and usually fatal form of advanced lymphoma.

Treadway said she remembers intently checking the name and date of birth, certain she had the wrong patient, then rebooting the computer several times “like I was going to get a different answer.”

“The difference is that I knew exactly who to call and what to do,” said Treadway, whose husband has been cancer-free for more than a decade. “In the event of bad news, a doctor has to surround the patient with ‘I am here for you and here’s the plan.'”

Schapira agrees. “Clinicians have to start tackling the issues that have arisen as a result of instant access,” she said.

Tele-Monitoring Can Reduce Medical Appointments For Low-Risk Pregnancies

March 27, 2018

When Allison Matthews was pregnant with her first child four years ago, her obstetrics clinic scheduled frequent appointments to make sure everything was proceeding normally.

“I was taking time off work and it wasn’t doing a lot for me,” said Matthews, who was considered at low risk for complications like pregnancy-related high blood pressure, also known as preeclampsia. “I kind of felt like I was almost doing it more for the clinic’s benefit than for myself.”

When she got pregnant again early last summer, the obstetrics practice at the Mayo Clinic in Rochester, Minn. gave her the option of coming in for just eight clinic visits rather than the usual 12 to 14. Matthews is a clinical services designer at the Mayo Clinic.

As part of its OB Nest program for low-risk expectant mothers, she would monitor her weight and track her blood pressure and fetal heart rate at home with equipment provided by the clinic. If she had abnormal results or any questions or concerns, she could contact her nurse online or by phone.

If she wished, she could join a social media group of other OB Nest patients monitored by clinic nurses.

Matthews loved the idea. The approach fit with her wish to treat pregnancy as a normal, healthy process rather than a medical illness that required frequent clinical interventions.

Doing the tests at home also made monitoring the baby’s progress a family event with her husband, Marc, and 4-year-old son, Gus, who could listen to his sister’s heartbeat.

“It was something we explored together rather than having it done for us,” said Matthews, 35. Their daughter, Lottie, was born about a month ago.

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Technology increasingly allows clinicians and patients to connect online, via video or remote monitoring rather than face-to-face. But most obstetrics practices continue to follow the traditional model that includes at least a dozen in-person office visits over the course of an average 40-week pregnancy, with lab work and ultrasounds at intervals along the way.

According to the American College of Obstetricians and Gynecologists, the standard pregnancy visit schedule is once every four weeks up to 28 weeks, every two weeks until 36 weeks, and weekly after that.

Although prenatal care is important for healthy outcomes, how much low-risk pregnancies need is debatable, health researchers say.

A study published in the Journal of Perinatology in 2016 found that babies born to women with uncomplicated pregnancies who had more than 10 prenatal visits were no healthier than those born to women with fewer, based on outcomes such as admission to the neonatal intensive care unit, low scores on the Apgar test that evaluates a newborn’s wellbeing, and death. Women with more than 10 prenatal visits, were, however, more likely to be induced or have a cesarean section delivery, the study found.

Patients at the Mayo obstetrics clinic in Rochester, many of whom, like Matthews, are employees of the medical center, can still go the traditional route. They can also opt for OB Nest or have joint appointments with other pregnant women in a group.

“Our goal is that OB Nest care becomes the model for low-risk women,” said Dr. Yvonne Butler Tobah, a Mayo obstetrician and health sciences researcher. Most pregnancies are low-risk, and if more patients choose OB Nest, which was added as a standard option for patients in 2016, it frees up time for doctors and midwives to focus on patients with high-risk pregnancies, she said.

But fewer visits may not translate into out-of-pocket savings on health care costs for women, since professional service fees for pregnancy, labor and delivery and postpartum care are typically bundled if the woman uses the same physician or physician group, said Katy Kozhimannil, an associate professor of public health at the University of Minnesota who studies women’s health care policy.

Women find savings in other ways, said Butler Tobah.

Many patients say the convenience helps save time and money, Butler Tobah said. “If it was their second or third child, patients [with an appointment at the clinic have] to pay for parking, get child care and wait in the doctor’s office, only to be told after a 15-minute visit that their pregnancy was fine.”

The potential of programs like OB Nest to make care more convenient and easily accessible to women who don’t live in urban areas is very appealing, said Kozhimannil. Although Mayo offers the program only in Rochester, it is moving ahead with plans to offer OB Nest to patients outside the Rochester area, said Butler Tobah.

Other obstetrics practices are experimenting with remote-monitoring programs for low-risk expectant mothers, said Dr. Nathaniel DeNicola, co-chair of the telehealth task force for the American Congress of Obstetricians and Gynecologists.

At the George Washington University Medical Faculty Associates in the District of Columbia, where he works, they’re one of several practices nationally using an app called Babyscripts to educate expectant moms, who can also transmit their weight and blood pressure data to the practice via a Wi-Fi connection. Some expectant mothers who use the app have fewer clinical appointments compared with the standard, he said.

A crucial element of these emerging remote-monitoring programs is that they’re closely integrated with the work of clinical staff, DeNicola said.

“All the remote monitoring is a way of augmenting traditional care, not replacing it,” DeNicola said.

As Trump Targets Immigrants, Elderly Brace To Lose Caregivers

March 26, 2018

BOSTON — After back-to-back, eight-hour shifts at a chiropractor’s office and a rehab center, Nirva arrived outside an elderly woman’s house just in time to help her up the front steps.

Nirva took the woman’s arm as she hoisted herself up, one step at a time, taking breaks to ease the pain in her hip. At the top, they stopped for a hug.

“Hello, bella,” Nirva said, using the word for “beautiful” in Italian.

“Hi, baby,” replied Isolina Dicenso, the 96-year-old woman she has helped care for for seven years.

The women each bear accents from their homelands: Nirva, who asked that her full name be withheld, fled here from Haiti after the 2010 earthquake. Dicenso moved here from Italy in 1949. Over the years, Nirva, 46, has helped her live independently, giving her showers, changing her clothes, washing her windows, taking her to her favorite parks and discount grocery stores.

Now Dicenso and other people living with disabilities, serious illness and the frailty of old age are bracing to lose caregivers like Nirva due to changes in federal immigration policy.

Nirva is one of about 59,000 Haitians living in the U.S. under Temporary Protected Status (TPS), a humanitarian program that gave them permission to work and live here after the January 2010 earthquake devastated their country. Many work in health care, often in grueling, low-wage jobs as nursing assistants or home health aides.

Now these workers’ days are numbered: The Trump administration decided to end TPS for Haitians, giving them until July 22, 2019, to leave the country or face deportation.

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In Boston, the city with the nation’s third-highest Haitian population, the decision has prompted panic from TPS holders and pleas from health care agencies that rely on their labor. The fallout offers a glimpse into how changes in immigration policy are affecting older Americans in communities around the country, especially in large cities.

Ending TPS for Haitians “will have a devastating impact on the ability of skilled nursing facilities to provide quality care to frail and disabled residents,” warned Tara Gregorio, president of the Massachusetts Senior Care Association, which represents 400 elder care facilities, in a letter published in The Boston Globe. Nursing facilities employ about 4,300 Haitians across the state, she said.

“We are very concerned about the threat of losing these dedicated, hardworking individuals, particularly at a time when we cannot afford to lose workers,” Gregorio said in a recent interview. In Massachusetts, 1 in 7 certified nursing assistant (CNA) positions are vacant, a shortage of 3,000 workers, she said.

Nirva (left) helps Isolina Dicenso into her car for an outing. (Melissa Bailey/KHN)

Nationwide, 1 million immigrants work in direct care — as CNAs, personal care attendants or home health aides — according to the Paraprofessional Healthcare Institute, a New York-based organization that studies the workforce. Immigrants make up 1 in 4 workers, said Robert Espinoza, PHI’s vice president of policy. Turnover is high, he said, because the work is difficult and wages are low. The median wage for personal care attendants and home health aides is $10.66 per hour, and $12.78 per hour for CNAs. Workers often receive little training and leave when they find higher-paying jobs at retail counters or fast-food restaurants, he said.

The country faces a severe shortage in home health aides. With 10,000 baby boomers turning 65 each day, an even more serious shortfall lies ahead, according to Paul Osterman, a professor at Massachusetts Institute of Technology’s Sloan School of Management. He predicts a national shortfall of 151,000 direct care workers by 2030, a gap that will grow to 355,000 by 2040. That shortage will escalate if immigrant workers lose work permits, or if other industries raise wages and lure away direct care workers, he said.

Nursing homes in Massachusetts are already losing immigrant workers who have left the country in fear, in response to the White House’s public remarks and immigration proposals, Gregorio said. Nationally, thousands of Haitians have fled the U.S. for Canada, some risking their lives trekking across the border through desolate prairies, after learning that TPS would likely end.

Employers are fighting to hold on to their staff: Late last year, 32 Massachusetts health care providers and advocacy groups wrote to the Department of Homeland Security urging the acting secretary to extend TPS, protecting the state’s 4,724 Haitians with that special status.

“What people don’t seem to understand is that people from other countries really are the backbone of long-term care,” said Sister Jacquelyn McCarthy, CEO of Bethany Health Care Center in Framingham, Mass., which runs a nursing home with 170 patients. She has eight Haitian and Salvadoran workers with TPS, mostly certified nursing assistants. They show up reliably for 4:30 a.m. shifts and never call out sick, she said. Many of them have worked there for over five years. She said she already has six CNA vacancies and can’t afford to lose more.

“There aren’t people to replace them if they should all be deported,” McCarthy said.

Nirva works 70 hours a week taking care of elderly, sick and disabled patients. She started working as a CNA shortly after she arrived in Boston in March 2010 with her two sons.

She chose this work because of her harrowing experience in the earthquake, which destroyed her home and killed hundreds of thousands, including her cousin and nephew. After the disaster, she walked 15 miles with her sister, a nurse, to a Red Cross medical station to try to help survivors. When she got there, she recounted, the guards wouldn’t let her in because she wasn’t a nurse. Nirva spent an entire day waiting for her sister in the hot sun, without food or water, unable to help. It was “very frustrating,” she said.

“So, when I came here — I feel, people’s life is very important,” she said. “I have to be in the medical field, just to be able to help people.”

Caregiver Nirva and Isolina Dicenso have grown close, bonding in part over their Catholic faith. “Thank God I met this woman,” Dicenso, 96, says of Nirva. (Melissa Bailey/KHN)

The work of a CNA or home health aide — which includes dressing and changing patients and lifting them out of bed — was difficult, she found.

“At the beginning, it was very tough for me,” Nirva said, especially “when I have to clean their incontinence. … Some of them, they have dementia, they are fighting. They insult you. You have to be very compassionate to do this job.”

A few months ago, Nirva was injured while tending to a 285-pound patient who was lying on her side. Nirva said she was holding the patient up with one hand while she washed her with the other hand. The patient fell back on her, twisting Nirva’s wrist.

Injury rates for nursing assistants were more than triple the national average in 2016, federal labor statistics show. Common causes were falling, overexertion while lifting or lowering, and enduring violent attacks.

Nirva works with a soft voice, a bubbling laugh and disarming modesty, covering her face with both hands when receiving a compliment. She said her faith in God — and a need to pay the bills to support her two sons, now in high school and college — help her get through each week.

She started caring for Dicenso in her Boston home as the older woman was recovering from surgery in 2011. Like many older Americans, Dicenso doesn’t want to move out of her home, where she has lived for 63 years. She is able to keep living there, alone, with help from her daughter, Nirva and another in-home aide. She now sees Nirva once a week for walks, lunch outings and shopping runs. The two have grown close, bonding in part over their Catholic faith. Dicenso gushed as she described spending her 96th birthday with Nirva on a daylong adventure that included a Mass at a Haitian church. At home, Dicenso proudly displays a bedspread that Nirva gave her, emblazoned with the word LOVE.

On a recent sunny winter morning, Nirva drove Dicenso across town to a hilltop clearing called Millennium Park.

“What a beautiful day!” Dicenso declared five times, beholding the open sky and views of the Charles River. As she walked with a cane in one hand and Nirva’s hand firmly clasped in the other, Dicenso stopped several times due to pain in her hips.

“Thank God I have her on my arm,” Dicenso said. “Nirva, if I no have you on my arm, I go face-down. Thank God I met this woman.”

In addition to seeing Dicenso, Nirva works three shifts a week at a chiropractor’s office as a medical assistant. Five nights a week, she works the overnight shift, from 11 p.m. to 7 a.m., at a rehabilitation center in Boston run by Hebrew SeniorLife. CEO Louis Woolf said Hebrew SeniorLife has 40 workers with TPS, out of a total of 2,600.

It’s not clear how many direct care workers rely on TPS, but PHI calculates there are 34,600 who are non-U.S. citizens from Haiti, El Salvador, Nicaragua (for which TPS is ending next year) and Honduras, whose TPS designation expires in July. In addition, another 11,000 come from countries affected by Trump’s travel ban, primarily from Somalia and Iran, and about 69,800 are non-U.S. citizens from Mexico, PHI’s Espinoza said. Even immigrants with secure legal status may be affected when family members are deported, he noted. Under Trump, non-criminal immigration arrests have doubled.

The “totality of the anti-immigrant climate” threatens the stability of the workforce — and “the ability of older people and people with disabilities to access home health care,” Espinoza said.

Asked about the impact on the U.S. labor force, a DHS official said that “economic considerations are not legally permissible in TPS decisions.” By law, TPS designation hinges instead on whether the foreign country faces adverse conditions, such as war or environmental disaster, that make it unsafe for nationals to return to, the official said.

The biggest hit to the immigrant workforce that cares for older patients may come from another program — family reunification, said Robyn Stone, senior vice president of research at LeadingAge, an association of nonprofit groups that care for the elderly. Trump is seeking to scrap the program, which he calls “chain” migration, in favor of a “merit-based” policy.

Osterman, the MIT professor, said the sum of all of these immigration policy changes may have a serious impact. If demand for workers exceeds supply, he said, insurers may have to restrict the number of hours of care that people receive, and wages may rise, driving up costs.

“People aren’t going to be able to have quality care,” he said. “They’re not going to be able to stay at home.”

But since three-quarters of the nation’s direct care workers are U.S. citizens, then “these are clearly not ‘jobs that Americans won’t do,’” argued David Ray, spokesman for the Federation for American Immigration Reform, which supports more restrictive immigration policies. The U.S. has 6.7 million unemployed people, he noted. If the health care industry can’t find anyone to replace workers who lose TPS and DACA, he said, “then it needs to take a hard look at its recruiting practices and compensation packages. There are clearly plenty of workers here in the U.S. already who are ready and willing to do the work.”

Angelina Di Pietro, Dicenso’s daughter and primary caretaker, disagreed. “There’s not a lot of people in this country who would take care of the elderly,” she said. “Taking care of the elderly is a hard job.”

“Nirva, pray to God they let you stay,” said Dicenso, sitting back in her living-room armchair after a long walk and ravioli lunch. “What would I do without you?”

Reporter’s Notebook: The Tale Of Theranos And The Mysterious Fire Alarm

March 21, 2018

It was November 2014, and I was working on a feature story about a buzzed-about blood-testing company in Silicon Valley that promised to “disrupt” the lab industry with new technology. The company, Theranos, claimed its revolutionary finger-prick test would be a cheap and less painful way to screen for hundreds of diseases with just a few drops of blood. Old-fashioned venous blood draws, where the patient watches as vial after vial of blood is collected, would quickly become obsolete, Theranos promised.

The interviews took a month to arrange. The public relations officer wanted to know, did I “plan on sourcing other people?” and implied that CEO Elizabeth Holmes might not be available to me if I did talk to other sources. I rejected that condition, but finally the company’s public relations contacts agreed to let me visit its site at the Walgreens in Palo Alto, Calif. — one of the first such setups in the country — followed by a sit-down interview with Holmes at her office.

I arrived at the Walgreens on the morning of Nov. 4 and was met by two Theranos press representatives who would supervise my visit. I took out my recording equipment (the story was for NPR) and began approaching patients who were waiting in line to check in for testing. Some didn’t want to talk to a reporter, but others were open and gracious, sharing with me the reasons they had decided to give Theranos a try. One couple offered to let me come with them into the small testing room, set up to feel like a relaxing spa.

A pattern quickly emerged — none of the patients I talked to that day could get a finger-prick test, as promised. Instead, they received a regular venous blood draw, the same as I’d received on numerous occasions at my doctor’s office, though the phlebotomist said the needle was slightly smaller.

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I asked the phlebotomist: Was this standard? Did most patients get the venous draw? She told me they “did more finger sticks than venous draws,” but couldn’t give me a number. One of the PR people approached me — I was not authorized to talk to the phlebotomist, he said — and asked me to erase the audio I had recorded. I declined.

I asked him: Why were none of the patients getting a finger prick? Just bad luck and timing, he said. This wasn’t how it usually was, he promised. And wouldn’t I just rather get a finger prick myself and report on the experience, as so many other journalists had agreed to do?

I said no. I needed an actual patient to make a compelling radio story. So, I continued waiting for other patients.

Soon, the two Theranos representatives approached me again — with a third on the phone, who said she wanted to talk to me. They were getting complaints about my asking patients questions, she told me. The main Theranos office had gotten several calls from people who had been in the Walgreens that morning, she claimed, complaining that a reporter was bothering them.

I hadn’t pressured anyone. The patients I’d interviewed had all been perfectly friendly and willing. I’ve also been a health reporter for 10 years, and never have I been told I was pushing patients to do something that made them uncomfortable.

Something seemed very wrong.

Soon, one of the Theranos representatives approached me again, clearly nervous. They appeared worried. Unless I found a patient getting a finger prick, he said, they would likely have to cancel my interview with Holmes.

It was clearly a threat to try to steer me away from where the story was taking me: Theranos seemed to be doing very few, if any, of its revolutionary tests on actual patients. I asked the press representatives to get the other one on the phone again; I didn’t like being threatened and I wanted to hash it out with her.

Meanwhile, I sat down with another couple, who had driven 45 minutes to experience the vaunted finger prick. Would they too be steered to a traditional blood test?

As I was interviewing them — but before we knew which test they could get — a sudden and jolting BEEP BEEP BEEP reverberated through the drugstore. “Fire alarm!” someone called out, and we evacuated to the street.

I’d never been in a drugstore when the fire alarm went off. There was no smoke and no fire.

I decided to cancel the feature. I had pitched it as a consumer-focused story about how often “less is more” in health care. I clearly no longer had that story. I made a few more calls to various experts on lab testing to try to figure out what was happening: Was Theranos for real? I was given an interview with a lawyer at Theranos, who promised me that “significantly more than 50 percent of the tests are done with a finger prick,” though she would say no more.

Now that Theranos has been implicated in massive fraud, that encounter serves as a reminder of the skepticism both journalists and health care consumers need to have in an age when public relations, marketing and advertising try to guide the story and our treatment.

Theranos generated huge hype and laudatory coverage in places like The New Yorker, Wired and Fortune by selling a compelling idea — even as its PR people couldn’t show me an actual patient who had benefited. Sometimes, in health care, an idea that seems too good to be true, isn’t. We all — patients and journalists — have to do our due diligence.

The PR tactics Theranos employed blocked journalists from providing the kind of scrutiny that might have revealed the fantasy the company was weaving for investors sooner.

And 11 months after my experience at that Walgreens, John Carreyrou of The Wall Street Journal published the first of his groundbreaking investigations surrounding Theranos, blowing the lid off of the company’s fraudulent claims. Of the 240 types of blood tests the company said it did, only 15 used finger-pricking.

Now comes the news that Theranos has accepted a settlement in the fraud case with the Securities and Exchange Commission. Which has me thinking.

Had someone pulled the fire alarm? I’ve been suspicious since the moment it happened.

Last week, I wrote to Theranos to ask. No surprise: They did not respond.

Research Misconduct Allegations Shadow Likely CDC Appointee

March 20, 2018
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President Donald Trump’s likely pick to lead the Centers for Disease Control and Prevention is facing significant criticism because of a 20-year-old controversy over shoddy HIV research.

The Army in 1994 acknowledged accuracy issues with HIV vaccine research led by Dr. Robert Redfield, who is expected to head the CDC, but concluded at the time that the data errors did not constitute misconduct.

Yet one of the whistleblowers who first raised the matter to the Army told Kaiser Health News this week that he remains so troubled about Redfield’s handling of the vaccine research that he has decided to speak out publicly.

Redfield was principal investigator over clinical trials of a treatment vaccine at the Walter Reed Army Institute of Research. The research was conducted at a time when there was intense pressure to come up with a treatment for HIV/AIDS, which often killed patients within a matter of months.

“Either he was egregiously sloppy with data or it was fabricated,” said former Air Force Lt. Col. Craig Hendrix, a doctor who is now director of the division of clinical pharmacology at Johns Hopkins University School of Medicine. “It was somewhere on that spectrum, both of which were serious and raised questions about his trustworthiness.”

In a letter to Trump this week, Washington Sen. Patty Murray, the ranking Democrat on the health committee, cited the research controversy as an example of a “pattern of ethically and morally questionable behavior” by Redfield that should prompt the president to reconsider the appointment.

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Redfield’s appointment, which does not require Senate confirmation, was leaked to the news media over the weekend. Redfield did not respond to questions, and the Department of Health and Human Services, which oversees the CDC, declined to comment.

Redfield, who denied any scientific misconduct at the time, is now an HIV/AIDS expert at the University of Maryland School of Medicine. He has been praised by his supporters for his care of patients. He oversees a clinical program that treats 6,000 patients in the Baltimore-Washington area, according to an online bio.

But Redfield’s critics said the expected appointment demonstrates that the Trump administration is not vetting appointees thoroughly. The first CDC head, Brenda Fitzgerald, stepped down in January after a controversy over her purchase of tobacco stocks, and former HHS Secretary Tom Price resigned late last year amid criticism over his use of government and private planes for official travel.

“The White House claimed they would do better background checks,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “But that statement is dangerously laughable. If they had done a proper background check, they wouldn’t have chosen Dr. Redfield.”

Public Citizen, a Washington watchdog group, was a leading critic of the Army’s handling of Redfield’s data at the time and obtained and published documents that detailed the controversy.

Hendrix, who was the director of an Air Force HIV clinical unit when he raised the concerns, said: “Two members of his [Redfield’s] team told me they had tried to replicate the analysis, but they couldn’t. When they tried to go to the Army, they said they were ignored.”

After Hendrix couldn’t replicate the results, he drafted a letter to his superiors reporting the data problems.

Hendrix said Redfield’s superiors initially told him not to send a letter detailing the concerns. Instead, the military scheduled a meeting with Redfield and other researchers so Hendrix could discuss the concerns. In the meeting, Hendrix recalled, Redfield acknowledged he had overstated how promising the results were.

“I thought it was resolved,” said Hendrix, who said he later called Redfield to say he was proud to work in an organization that could openly discuss such concerns.

However, Hendrix soon heard Redfield make the same inaccurate representations of the data at a conference and decided to file an official complaint requesting an investigation into scientific misconduct.

An Air Force institutional review board also recommended that the Army launch an inquiry stating: “The committee agreed the information presented by Dr. Redfield seriously threatens his credibility as a researcher and has the potential to negatively impact AIDS research funding for military institutions as a whole.”

But the Army did not appear to launch a full investigation, said Hendrix, who was interviewed at the time by the military official who conducted the inquiry. The military official declined Hendrix’s attempts to provide documented evidence, telling him the investigation was “informal.”

Hendrix later asked the commander of his hospital about the outcome of the investigation. He recalled that the commander called another officer to ask.

“I just remember him saying “Yes, sir,” he said. “When he hung up, he told me, ‘We will not be discussing this again.’”

Redfield was transferred from the laboratory he headed and assigned to treat patients, although the Army said he was not being punished. The Army also said the data would be corrected, and the military scrapped the program.

The project had earlier drawn criticism because Congress had set aside $20 million for the vaccine after lobbying by a former senator on behalf of the manufacturer.

Hendrix said he occasionally interacted over the years with Redfield and holds no grudges.

“Before this happened, he made important contributions to HIV-prevention efforts,” he said. “I respected him.”

However, he said, he remains disturbed by the military’s handling of the matter. He teaches a class on medical ethics and uses his own experience without naming Redfield to describe to his students the ethical quandaries faced in research.

Faulty data can lead other scientists to repeat the same mistakes and prompt participants to seek out trials for drugs and vaccines that don’t work.

“It’s a huge waste of funds,” he said. “But just as importantly, it diminishes trust, which is essential in science. If truth is eroded, then the whole enterprise falls apart.”

Paying Hospitals To Keep People Out Of Hospitals? It Works In Maryland.

March 19, 2018

Saturdays at Mercy Medical Center used to be perversely lucrative. The dialysis clinic across the street was closed on weekends.

That meant the downtown Baltimore hospital would see patients with failing kidneys who should have gone to the dialysis center. So Mercy admitted them, collecting as much as $30,000 for treatment that typically costs hundreds of dollars.

“That’s how the system worked,” said Mercy CEO Thomas Mullen. Instead of finding less expensive alternatives, he said, “our financial people were saying, ‘We need to admit them.’”

Maryland’s ambitious hospital-payment overhaul, put in place in 2014, has changed such crass calculations, which are still business as usual for most of American health care. A modification of a long-standing state regulation that would be hard to replicate elsewhere, the system is nevertheless attracting national attention, analysts say.

As soon as Mercy started being penalized rather than rewarded for such avoidable admissions, it persuaded the dialysis facility to open on weekends, saving government insurance programs and other payers close to $1 million annually.

In the four years since Maryland implemented a statewide system of pushing hospitals to lower admissions, such savings are adding up to hundreds of millions of dollars for the taxpayers, employers and others who ultimately pay the bills, a new report shows.

Maryland essentially pays hospitals to keep people out of the hospital. Analysts often describe the change as the most far-reaching attempt in the nation to control the medical costs driving up insurance premiums and government spending.

Like a giant health maintenance organization, the state caps hospitals’ revenue each year, letting them keep the difference if they reduce inpatient and outpatient treatment while maintaining care quality. Such “global budgets,” which have attracted rare, bipartisan support during a time of rancor over health care, are supposed to make hospitals work harder to keep patients healthy outside their walls.

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Maryland’s system, which evolved from a decades-old effort to oversee hospitals as if they were public utilities, regulates all hospital payments by every private and government insurer. That makes it radically different from piecemeal attempts to lasso health spending, such as creating accountable care organizations, which seek savings among smaller groups of patients.

From the program’s launch in 2014 through 2016, per capita hospital spending by all insurers grew by less than 2 percent a year in Maryland. That’s below the economic growth rate, according to new results from the state’s hospital regulator and the federal Department of Health and Human Services.

Keeping hospital spending below economic growth — defined four years ago as 3.58 percent annually — is a key goal for the program and something that rarely happened.

Counting The Savings

The state plan saved the Medicare program for seniors and the disabled about half a billion dollars over three years and achieved “substantial reductions in hospitalization and especially improvements in quality of care,” said a Medicare spokesman.

In the three years measured so far, he added, “the state has already exceeded the required performance for the full five years of the model.”

As high costs for hospital care have been growing more slowly nationwide, Maryland hospital costs over that period rose even less.

“It looks like it has very strong results,” said John McDonough, a Harvard health policy professor who helped craft the federal Affordable Care Act.

What Maryland is doing, he said, “is pretty bold and it’s pretty thoughtfully done and has generated a huge amount of interest around the country.”

Comprehensive results through 2016 are the most recent available from Maryland and HHS, although savings continued last year, Maryland officials said. Independent researchers found mixed results for savings in the earlier years of Maryland’s system.

Maryland’s global budgets saved Medicare $293 million — 1.8 percent of total Medicare spending — in 2014 and 2015, research firm RTI International reported in August.

A separate paper from a team led by Eric Roberts at the University of Pittsburgh found that Maryland’s program in those years couldn’t be clearly credited for reducing hospital use.

The system’s advocates say several years of results are needed to show it’s working.

“These are not fake savings,” said Joseph Antos, an economist at the conservative-leaning American Enterprise Institute who sits on Maryland’s hospital-payment commission. “It didn’t happen instantaneously. It’s taken this number of years to achieve the kinds of savings that you see” for 2016 and beyond.

Even boosters such as Joshua Sharfstein, the former Maryland health secretary who got approval for global budgets from the Obama administration, say the system is far from perfect or finalized.

“There is a range of responses. Some hospitals have been able to do more than others,” said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Change in health care is notoriously slow.”

Hospitals have lagged in delivering primary, preventive care to people with chronic conditions such as asthma, diabetes and heart failure, especially in low-income neighborhoods.

Maryland’s system does little to control soaring costs of drugs or nursing home care, doctors’ office treatments and other care not connected to hospitals, although policymakers are working on proposals to do both.

Even so, “what Maryland has done is just so far ahead of many of these other models” to try to control costs, said Dan D’Orazio, a management consultant who has worked with hospitals across the country. One Maryland hospital CEO told him: “This has fundamentally changed how we wake up and do business every day,” D’Orazio said.

Seeing A Difference

At Mercy, described by policymakers as more aggressive than many hospitals in watching costs, about a third of the patients now leave the hospital with medications in hand, said Dr. Wilma Rowe, the hospital’s chief medical officer. That bypasses the tendency for patients to skip a follow-up pharmacy visit and risk landing back in the emergency room.

A statewide data network notifies Mercy and other hospitals when one of their patients ends up in an emergency room somewhere else. That helps coordinate care.

Greater Baltimore Medical Center, north of the city, has hired dozens of primary care doctors to track around 1,000 people with diabetes — staying in touch, advising on diets and keeping them on insulin so they avoid the hospital.

Often clinicians visit elderly patients’ homes to prevent what might turn into an ambulance call and admission, said the hospital’s CEO, Dr. John Chessare.

Before global budgets, “I’d look at the waiting room in the [emergency department], and if it wasn’t full I’d get scared,” he said.

Now he worries it might be full of people who could be better treated elsewhere — including Gilchrist, a GBMC affiliate delivering hospice care for those at the end of life.

These days, he said, “we consider it a defect if someone with chronic disease dies in the hospital.”

The Other Opioid Crisis: Hospital Shortages Lead To Patient Pain, Medical Errors

March 16, 2018

Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.

As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.

In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.

In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases. Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

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In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”

In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.

Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.

Marchelle Bernell (Courtesy of Marchelle Bernell)

Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.

Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.

“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”

Dr. Beverly Philip (Courtesy of the American Society of Anesthesiologists)

Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.

“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”

During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.

The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kan. The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.

At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.

“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.

When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.

The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.

Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.

Dr. Shalini Shah (Courtesy of University of California-Irvine)

The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

“We essentially have to ration to patients that are most vulnerable,” Shah said.

Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.

Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.

Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.

“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.

Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.

Dr. Howie Mell (Courtesy of Howie Mell)

“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.

Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.

Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.

When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

“But they didn’t,” he said.