The pattern identified in the 340B comments suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

This article first appeared September 11, 2018 on Kaiser Health News.

By Sarah Jane Tribble

A proposal to sharply cut a drug discount program that many hospitals rely on drew some 1,400 comments when the Trump administration announced its plan last year. Hundreds appeared to come from patients across the country — pleas from average Americans whose treatments for diseases such as cancer depend on costly medicines.

But a review of the responses found that some individuals were not aware they apparently had become part of an organized campaign to oppose what's known as the "340B" program. Some had no memory of signing anything, much less sending their opinions about it.

Of the 1,406 comments that specifically mentioned 340B — part of several thousand comments submitted on a broad proposal to revise medical payment systems — about half included the same or similar wording and were submitted anonymously, an analysis by Kaiser Health News found. Those comments lamented "abuse" of the drug discounts, faulted hospitals for being "greedy" and used phrasing such as "quality, affordable, and accessible."

Two that were duplicated hundreds of times made the very same grammatical mistake.

They "are clearly related," said Robert Leonard, a forensic linguistic expert at Hofstra University whose team analyzed the submissions for KHN.

In fact, the wording in the duplicate comments tracks language in a formal letter submitted to regulators by a nonprofit trade group, the Community Oncology Alliance, which receives funding from pharmaceutical companies.

Cancer survivor Janice Choiniere's name is on a public comment saying reform of the 340B program will help "those suffering from this insidious disease." But when reached by phone, the 69-year-old Florida resident said she had "no idea" what the program is and didn't recall signing a petition.

"My first thought is, I don't fill out and send in responses casually," Choiniere said. "I'm hoping nobody lifted my information."

The quarter-century-old federal program requires pharmaceutical companies to sell certain drugs at steep discounts to eligible hospitals and clinics, which don't have to share their savings with patients. Critics, including Republican lawmakers, have questioned what the facilities do with the money. Doctors in private practice, who are not eligible for the reduced rates, have warned that the program's continued growth makes it susceptible to exploitation.

The administration's plan, finalized in November, reduced by $1.6 billion annually what the Centers for Medicare & Medicaid Services pays for the targeted drugs. In late July, the agency proposed expanding those payment cuts.

As with any proposed rule, the purpose of requesting public comments is to help lawmakers and regulators consider the potential effects of their actions. But the pattern identified in the 340B comments, which were posted online by CMS, suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

"It feels like inappropriate influence," said Peter Ubel, a physician and behavioral scientist at Duke University's Fuqua School of Business. "When you have a life-threatening illness, you need to know you can trust your physician to care about your interests ahead of their own."

KHN reached 10 individuals whose names appeared in the comments — either as a signature on a personal note or on a petition also signed by others. All were patients, former patients or caregivers seen at private practices connected to the Community Oncology Alliance.

Two patients confirmed they had written notes, although they couldn't say when. Several said they must have signed or written something amid the paperwork handed to them at a doctor's office during appointments or in follow-up correspondence. A few drew mental blanks.

The name of an 84-year-old melanoma patient shows as an online signature in an individual public comment that described the program's reform as a matter of "life or death." But the Florida man, who asked not to be identified, had little recollection of writing it. His wife remembered that he signed something at his doctor's office "out front on a clipboard" before getting his biweekly cancer treatment.

"If my doctor wanted me to sign something, I would sign it for him," the man said. He "saved my life."

Julie Yarbrough, whose husband received treatment at New England Cancer Specialists in Maine, remembered signing a petition "at the [doctor's] check-in area" about hospitals abusing 340B discounts. She was the only individual contacted who had a basic understanding of the program.

The patients reached by KHN sought care at either New England Cancer Specialists, which has three locations in Maine, or Florida Cancer Specialists, which runs nearly 100 treatment centers in that state. Data posted on the federal website regulations.gov show that more than 60 percent of the 340B-specific comments originated in Florida.

"We do a good job of educating patients and letting them know how to get involved," said Michael Diaz, director of patient advocacy for Florida Cancer Specialists and vice president on the Community Oncology Alliance's executive committee. "They need to be able to contribute and give their opinion."

Steve D'Amato, executive director of New England Cancer Specialists and an Alliance board member, mentioned patients' support in a letter accompanying a petition posted multiple times to the government portal Oct. 10. The petition included the trade group's website; D'Amato noted that "patient signatures obtained in just 2 days" were attached.

When asked recently about patients who didn't recall signing something, D'Amato said he did not have the petition in front of him and referred all questions to the Alliance's executive director, Ted Okon. In an interview, Okon denied that the organization had any role in soliciting patient comments.

"We didn't do anything with patient petitions," said Okon, although talking points and material were sent to practices nationwide for them to use when submitting comments. "This is what we do in terms of advocating."

Susannah Rose, scientific director of research in the Cleveland Clinic's patient experience office, said there is "always a worry about coercion" when doctors make a request of patients, but more so when oncologists do the asking.

"Cancer patients often feel very much in the hands of their oncologists, and they are often suffering from significant distress," said Rose, who serves on the ethics committee of the American Society of Clinical Oncology.

The Washington-based Alliance represents private oncology practices as well as about 50 corporate members, according to its website. Formed in 2003 when Congress approved Medicare's prescription drug program, it was a leading critic of a controversial 2016 proposal to change how CMS paid for some drugs in Medicare. The group's revenue nearly quadrupled that year, to $16.3 million from $4.4 million in 2015, according to federal tax filings. The proposal never became reality.

Pharmaceutical giants Sanofi, Pfizer, Eli Lilly, Bristol-Myers Squibb and Merck each confirmed paying annual dues of $75,000 to the Alliance. The five companies also paid it nearly $1 million between 2014 and 2017 for research papers, conferences, filming and patient education, according to corporate transparency reports.

Walgreens and PhRMA, the pharmaceutical industry trade group, also confirmed membership but did not disclose how much they pay in dues. Okon said corporate membership fees range from $25,000 to $75,000 annually while individual oncologists and their practices pay "usually on the order of a thousand dollars, two thousand dollars."

Drug manufacturers do not influence the Alliance's position on 340B, he said, noting in an email that "correlation is not causality."

After the comment period ended, CMS slashed 340B payments to hospitals by $1.6 billion annually. Medicare had been paying hospitals 6 percent above a drug's average sales price; it now pays them 22.5 percent less than the average sales price.

CMS Administrator Seema Verma and Eric Hargan, deputy secretary of the Health and Human Services Department, emphasized that public comments played into their decision. In the 1,133-page final rule, they said they shared the concern that current Medicare payments "are well in excess of the overhead and acquisition costs" for drugs bought under the program.

"We thank the commenters for their support," they wrote.

Thousands of cases across the country allege that enfeebled nursing home patients endured hospital treatments for sepsis that many of the lawsuits claim never should have happened.

This article first appeared September 05, 2018 on Kaiser Health News.

By Fred Schulte and Elizabeth Lucas and Joe Mahr, Chicago Tribune

Shana Dorsey first caught sight of the purplish wound on her father's lower back as he lay in a suburban Chicago hospital bed a few weeks before his death.

Her father, Willie Jackson, had grimaced as nursing aides turned his frail body, exposing the deep skin ulcer, also known as a pressure sore or bedsore.

"That was truly the first time I saw how much pain my dad was in," Dorsey said.

The staff at Lakeview Rehabilitation and Nursing Center, she said, never told her the seriousness of the pressure sore, which led to sepsis, a severe infection that can quickly turn deadly if not cared for properly. While a resident of Lakeview and another area nursing home, Jackson required several trips to hospitals for intravenous antibiotics and other sepsis care, including painful surgeries to cut away dead skin around the wound, court records show.

Dorsey is suing the nursing center for negligence and wrongful death in caring for her dad, who died at age 85 in March 2014. Citing medical privacy laws, Lakeview administrator Nichole Lockett declined to comment on Jackson's care. In a court filing, the nursing home denied wrongdoing.

The case, pending in Cook County Circuit Court, is one of thousands across the country that allege enfeebled nursing home patients endured stressful, sometimes painful, hospital treatments for sepsis that many of the lawsuits claim never should have happened.

My father was like my best friend. Most people go to their mom to talk and tell all their secrets, and for me it was my dad.

Shana Dorsey

Year after year, nursing homes around the country have failed to prevent bedsores and other infections that can lead to sepsis, an investigation by Kaiser Health News and the Chicago Tribune has found.

No one tracks sepsis cases closely enough to know how many times these infections turn fatal.

However, a federal report has found that care related to sepsis was the most common reason given for transfers of nursing home residents to hospitals and noted that such cases ended in death "much more often" than hospitalizations for other conditions.

A special analysis conducted for KHN by Definitive Healthcare, a private health care data firm, also suggests that the toll — human and financial — from such cases is huge.

Examining data related to nursing home residents who were transferred to hospitals and later died, the firm found that 25,000 a year suffered from sepsis, among other conditions. Their treatment costs Medicare more than $2 billion annually, according to Medicare billings from 2012 through 2016 analyzed by Definitive Healthcare.

In Illinois, about 6,000 nursing home residents a year who were hospitalized had sepsis, and 1 in 5 didn't survive, according to Definitive's analysis.

"This is an enormous public health problem for the United States," said Dr. Steven Simpson, a professor of medicine at the University of Kansas and a sepsis expert. "People don't go to a nursing home so they can get sepsis and die. That is what is happening a lot."

The costs of all that treatment are enormous. Court records show that Willie Jackson's hospital stays toward the end of his life cost Medicare more than $414,000. Medicare pays Illinois hospitals more than $100 million a year for treatment of nursing home residents for sepsis, mostly from Chicago-area facilities, according to the Medicare claims analysis.

Sepsis is a bloodstream infection that can develop in bedridden patients with pneumonia, urinary tract infections and other conditions, such as pressure sores. Mindful of the dangers, patient safety groups consider late-stage pressure sores to be a "never" event because they largely can be prevented by turning immobile people every two hours and by taking other precautions. Federal regulations also require nursing homes to adopt strict infection-control standards to minimize harm.

Yet the failures that can produce sepsis persist and are widespread in America's nursing homes, according to data on state inspections kept by the federal Centers for Medicare & Medicaid Services. Many of the lawsuits allege that bedsores and other common infections have caused serious harm or death. The outcome of these cases is not clear, because most are settled and the terms kept confidential.

Cook County, where the private legal community is known to take an aggressive approach to nursing homes, has more of these suits than any other metro area in the U.S., KHN and the Tribune found by reviewing court data.

State inspectors also cite thousands of homes nationally for shortcomings that have the potential to cause harm. Inspections data kept by CMS show that since 2015 94 percent of homes operating in Illinois have had at least one citation for conditions that increase the risk of infection. These citations include care related to bedsores, catheters, feeding tubes and the home's overall infection-control program.

"Little infections turn to big infections and kill people in nursing homes," said William Dean, a Miami lawyer with more than two decades of experience suing nursing homes on behalf of patients and their families.

Much of the blame, regulators and patient advocates say, lies in poor staffing levels. Too few nurses or medical aides raises the risks of a range of safety problems, from falls to bedsores and infections that may progress to sepsis or an even more serious condition, septic shock, which causes blood pressure to plummet and organs to shut down.

Staffing levels for nurses and aides in Illinois nursing homes are among the lowest in the country. In the six-county Chicago area, 78 percent of the facilities' staffing levels fall below the national average, according to government data analyzed by KHN.

Matt Hartman, executive director of the Illinois Health Care Association, which represents more than 500 nursing homes, acknowledged low staffing is a problem that diminishes the quality of nursing care.

Hartman blamed the state's Medicaid payment rates for nursing homes — about $151 a day per patient on average — which he said is lower than most other states. Medicaid makes up about 70 percent of the revenue at many homes, he said.

Last October, CC Care LLC, an Illinois nursing home group that specializes in treating mentally ill patients on Medicaid, filed for bankruptcy, arguing that the state's "financial troubles have been disastrous for all nursing homes."

In a July court filing, CC Care creditors' committee argued that the company couldn't stay afloat relying on Illinois Medicaid payments, which it called "slow, erratic and significantly less than what we are due."

Pat Comstock, executive director of the Health Care Council of Illinois, said nursing homes she represents "are operating in an increasingly difficult environment in Illinois, yet they continue to prioritize delivering the best care possible to residents in a safe and secure setting."

A Festering Complaint

Shana Dorsey remembers her father as a quiet but friendly man. He worked as a uniformed bank security guard and picked up extra cash fixing neighbors' cars in an empty lot adjacent to his West Side apartment building. He was a stickler for detail, who relished teaching his granddaughter the state capitals and was always ready to lend a hand to help his daughter, who now works for a Chicago property management firm.

But age and declining health caught up with the Army veteran, who by his early 80s began to exhibit signs of dementia and moved into an assisted living apartment.

Dorsey knew her dad needed more specialized care when she found him sitting in his favorite peach recliner in his apartment, unable to get up and incontinent.

He required more intense medical and personal care as his kidney disease worsened and he became more confused, medical records show. In his last 18 months of life, he cycled in and out of hospitals eight times for treatment of septic bedsores and other infections, according to court records.

The Chicago law firm representing Dorsey, Levin & Perconti, provided KHN and the Tribune with medical records and additional court filings that cover Jackson's care.

Jackson had two pressure sores in late November 2012 when he was first admitted to Lakeview nursing center from the Jesse Brown VA Medical Center in Chicago, according to lawyers for his daughter.

These wounds healed, but in late September 2013, Jackson spiked a fever and had an infected sore in his lower back that exposed the bone, causing what Dorsey's lawyers called "significant pain."

The nursing home transferred Jackson to Presence St. Joseph Hospital in Chicago, where surgeons cut away the dead skin and administered antibiotics. At that time, the sore was as wide as a grapefruit and had "copious purulent drainage, foul smell and bleeding," Dorsey's lawyers argue. Tests confirmed sepsis, and the wound had grown so deep that it infected the sacral bone in his back, a condition known as osteomyelitis, the lawsuit said.

In November 2013, Dorsey moved her father to another nursing home. He required three more hospital visits before Dorsey made the difficult decision to place Jackson in hospice care. He died March 14, 2014, from "failure to thrive," according to a death certificate.

In her suit, Dorsey, 39, argues that Lakeview nursing staff knew Jackson was at "high risk" for bedsores because of his declining health. Yet the home failed to take steps to prevent the injuries, such as turning and repositioning him every two hours, according to the suit. That didn't happen about 140 times in August 2013 alone, Dorsey's lawyers said.

"My father was like my best friend. Most people go to their mom to talk and tell all their secrets, and for me it was my dad," Dorsey said in a November 2015 deposition.

While Lakeview declined to discuss Jackson's treatment, it has denied negligence and argued in court filings that its actions were not to blame for Jackson's death. Lockett, the home's administrator, said the facility "strictly follows" all regulations to minimize the effects of skin breakdowns that can occur naturally with age.

"We are grateful for the daily opportunity to enhance the lives of seniors and other chronically ill populations in our community," Lockett said in a statement.

Infection Control

Poor infection control ranks among the most common citations in nursing homes. Since 2015, inspectors have cited 72 percent of homes nationally for not having or following an infection-control program. In Illinois, that figure stands at 88 percent of homes.

Illinois falls below national norms for risks of pressure sores or failure to treat them properly in nursing homes. Inspectors have cited 37 percent of the nation's nursing homes for this deficiency, compared with 60 percent in Illinois, according to CMS records. Only three states were cited more frequently.

Inspectors in November 2016 cited Alden Town Manor Rehabilitation and Health Care Center in Cicero, Ill., for neglect due to its care of an unnamed 83-year-old man with pressure ulcer sores that went untreated. Gangrene had set in by the time the staff sent him to the hospital, where surgeons ended up amputating his right leg above the knee, according to the inspectors' report and citation. Alden Town Manor had no comment.

Dean, the Miami lawyer, said that nursing home staffs often miss early signs of infection, which can start with fever and elevated heart rate, altered mental status or not eating. When those symptoms occur, nurses should call a doctor and arrange to transfer the patient to a hospital, but that process often takes too long, he said.

"They don't become septic on the ambulance ride over to the hospital," Dean said.

There is little agreement over how much staff should be required in nursing homes. Federal regulations simply mandate that a registered nurse must be on duty eight hours per day, every day. In 2001, a federal government study recommended a daily minimum of 4.1 hours of total nursing time per resident, which includes registered nurses, licensed practical nurses and certified nursing assistants, often referred to as aides. That never became an industry standard or federal regulation, however.

Most states set requirements lower and face industry resistance to raising the bar. A California law requiring 3.5 hours per resident as of this July 1 is drawing intense criticism from the industry, for instance.

In addition, staffing can fluctuate, particularly over the weekends. A recent KHN investigation found that on some days, nursing home aides could be in charge of twice as many residents as normal.

At a minimum, Illinois requires 2.5 hours of direct care daily for residents. Yet federal nursing home payroll data show that at least 1 in 4 Chicago-area nursing home residents live in facilities that aren't consistently providing that much care, KHN found.

Nationally, each aide is responsible for 10 residents on average; in the six-county Chicago area, the average is 13 residents per aide.

Federal officials have linked inadequate staffing to bedsores and other injuries, such as falls. If left unattended, even a small ulcer or sore can become septic, and once that happens, a patient's life is in imminent danger.

In October 2014, Milwaukee-based Extendicare denied wrongdoing but paid $38 million to settle a federal False Claims Act lawsuit that accused it of not having enough staff on hand in 33 nursing homes in eight states, including Indiana, and failing to take steps to prevent bedsores or falls.

In other cases, federal officials have alleged that some nursing homes overmedicate residents — which can result in injuries such as falls from beds or wheelchairs and bedsores — rather than staff up to care for them properly.

Little infections turn to big infections and kill people in nursing homes.

William Dean, a lawyer who represents patients and their families

In May 2015, owners of two nursing homes in Watsonville, Calif., agreed to pay $3.8 million to settle a whistleblower lawsuit alleging the homes persistently drugged patients, contributing to infections and pressure sores.

The suit alleged that an 86-year-old man who could barely move after receiving a shot of an anti-psychotic medication lost his appetite and spent most of the day in bed, "was not turned or repositioned and developed additional pressure ulcers." He ran a 102-degree fever, but the staff failed to notify his doctor for three days, according to the suit.

Hospital doctors later diagnosed the man with sepsis and an infected pressure ulcer. The home did not admit wrongdoing and had no comment.

Personal injury lawyers and medical experts say that poor infection control often sends nursing home residents to hospitals for emergency treatment — and that the stress can hasten death.

Elderly people often "don't have the ability to bounce back from an infection," said Dr. Karin Molander, a California emergency room physician and board member of the Sepsis Alliance advocacy group.

That odyssey of multiple, stressful trips to the hospital is a common thread in negligence and wrongful death lawsuits involving sepsis or bedsores. KHN identified more than 8,000 suits filed nationwide from January 2010 to March of this year that allege injuries from failing to prevent or treat pressure sores and other serious infections.

Molander said serious bedsores indicate "someone is being ignored for an extended time period."

"When we see patients like that we file [patient neglect] complaints with adult protective services," she said.

Some of these cases led to million-dollar jury verdicts. In 2017, a Kentucky jury awarded $1.1 million to the family of a woman who suffered from bedsores and sepsis in a nursing home. In a second case last year, a jury awarded $1.8 million to a widow who alleged a Utah nursing home failed to turn her husband often enough to prevent bedsores, which led to his death.

Lawyers filed more than 1,400 of the cases from January 2010 to March of this year in Cook County Circuit Court, which tops all metro areas across the country in the KHN sample.

Nursing homes complain that garish billboards to solicit clients are a fixture in Chicago, where many attorney websites also boast of recent million-dollar verdicts from bedsore cases alone.

"We see an incredible amount of lawsuits out there," said Hartman, of the Illinois nursing home association. "We feel we have a target on our backs."

Trial lawyers counter that nursing homes often try to duck responsibility for poor care by creating complex corporate structures to limit their liability. Yet Hartman derided these suits as "cash cows" for law firms that can rack up six-figure legal fees as cases drag on. The nursing home industry supports tort reforms that would compensate injured persons but also bring a quicker resolution of claims, he said.

"That is something that needs to be fixed in Illinois," Hartman said.

Avoidable Hospital Transfers

In September 2013, the Centers for Medicare & Medicaid Services said it was working to reduce avoidable transfers from nursing homes to hospitals. CMS had previously called these trips "expensive, disruptive and disorienting for frail elders and people with disabilities."

The plans came in the wake of a critical 2013 Department of Health and Human Services audit that found Medicare had paid about $14 billion in 2011 for these transfers. Care related to sepsis cost Medicare more than the next three costliest conditions combined, according to the audit.

The auditors have not checked in to see if Medicare has since reduced those costs and have no plans to do so, a spokesman for the HHS Office of Inspector General said.

However, Definitive Healthcare's analysis of billing data, modeled after the HHS audit, shows little change between 2012 and 2016, both in terms of deaths and costs.

Wendy Meltzer, executive director of Illinois Citizens for Better Care, said that hospital trips caused by treatment for sepsis can be "emotionally devastating" for confused elderly patients.

"It's not a choice anybody makes. It's horrible for people with dementia," Meltzer said. "Some never recover from that. It's a very real phenomenon and it's cruel."

A majority of the public also blamed high healthcare costs on waste and fraud, unnecessarily high hospital charges, excessive insurance profits, and the cost of new medical technologies.

This article first appeared September 08, 2018 on Kaiser Health News.

By Jordan Rau

Unexpected medical bills top the list of health care costs Americans are afraid they will not be able to afford, with 4 in 10 people saying they had received a surprisingly large invoice within the past year, according to a new poll.

The Kaiser Family Foundation poll found that 67 percent of people worry about unexpected medical bills, more than they dread insurance deductibles, prescription drug costs or the basic staples of life: rent, food and gas. (Kaiser Health News is an editorially independent program of the foundation.)

Thirty-nine percent of insured adults under age 65 said they had received a medical bill within the previous 12 months that they'd figured would be covered or that was higher than they anticipated. Half of those people said the bill was less than $500, but nearly 1 in 8 said they were on the hook for $2,000 or more.

A quarter of people who said they received a surprisingly large bill attributed it to a doctor, hospital or other provider that was not in their insurance network. Such providers often will not accept the amount an insurer thinks a procedure or test should cost, and they bill the patient for the difference. That practice, known as balance billing, is one of the most common types of outsize charges that KHN and NPR profile in the “Bill of the Month” series.

Another poll recently conducted by NORC at the University of Chicago, a research group, found similar numbers of people had received a surprise bill. The most common charges were for a physician's service or a lab test.

Once again, the Kaiser poll found that a majority of the public — regardless of political party — does not want insurers to be allowed to deny coverage or charge higher premiums because of someone's medical history or health status. Both practices were standard in the health insurance industry until they were outlawed by the Affordable Care Act in 2010.

Those protections would be suspended if a group of Republican attorneys general who assert the law is unconstitutional persuade a federal court judge in Texas this week that the health law be put on hold while their case against the ACA is litigated. The ACA protections are supported by at least 86 percent of Democrats, 71 of independents and 56 percent of Republicans, the poll found.

Americans said there was plenty of blame to go around for the high cost of health care. At the top, 78 percent of the public said excessive drug company profits were a major reason health care costs are rising. That is a 7 percentage point increase from 2011 and more than any other single reason. A majority of the public also blamed waste and fraud, unnecessarily high hospital charges, excessive insurance profits and the cost of new medical technologies.

The poll was conducted Aug. 23-28 among 1,201 adults. The margin of error was +/-3 percent.