Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases.
Under the new rules, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not effective, then the patients could receive the more expensive medication prescribed by their doctors.
Insurers use such “step therapy” to control drug costs in the employer-based insurance market as well as in Medicare’s stand-alone Part D prescription drug benefit, which generally covers medicine purchased at retail pharmacies or through the mail. The new option allows Advantage plans — an alternative to traditional, government-run Medicare — to extend that cost-control strategy to these physician-administered drugs.
In traditional Medicare, which covers 40 million older or disabled adults, those medications given by doctors are covered under Medicare Part B, which includes outpatient services, and step therapy is not allowed.
About 20 million people have private Medicare Advantage policies, which include coverage for Part D and Part B medications.
Some physicians and patient advocates are concerned that the pursuit of lower Part B drug prices could endanger very sick Medicare Advantage patients if they can’t be treated promptly with the medicine that was their doctor’s first choice.
Critics of the new policy, part of the administration’s efforts to fulfill President Donald Trump’s promise to cut drug prices, say it lacks some crucial details, including how to determine when a less expensive drug isn’t effective.
“Do you have to lose vision before you are allowed to use” medication approved by the Food and Drug Administration, asked Richard O’Neal, vice president for market access for Regeneron, which makes Eylea, a medicine that is injected into the eye to treat macular degeneration. In 2016, Medicare paid $2.2 billion for Eylea prescriptions for patients in traditional Medicare, more than any other Part B drug, according to government data.
Medicare Advantage insurers spend about $12 billion on Part B drugs, compared to the $25.7 billion traditional Medicare spent in 2016 on such drugs. Insurers that adopt the step therapy policy can apply it only to new prescriptions — medicine a patient hasn’t received in the past 108 days.
The change in policy gives insurers a new bargaining tool: Pharmaceutical makers may want to compete by cutting prices to get their product on the plans’ list of preferred lists, allowing patients to receive the medicines without step therapy pre-conditions. That “strengthens their negotiating position with the manufacturers,” Medicare chief Seema Verma said when she unveiled the policy last month.
It could also save patients money since they usually pay a portion of the Part B prescription cost. In addition, Medicare is requiring plans to share the savings with enrollees.
“Competition is a big factor in price concessions,” said Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, an industry trade group. But insurers haven’t had much leverage to negotiate lower prices for these drugs without strategies like step therapy, he said.
Federal health officials told insurers in a memo last month that they could substitute a less expensive Part B drug to treat a medical condition the FDA has not approved it for, if insurers can document that it is safe and effective. Yet coverage for a Part D drug is usually denied for a condition that doesn’t have FDA approval, according to the Center for Medicare Advocacy, which helps beneficiaries with appeals.
Several representatives of medical specialty groups recently met with Alex Azar, the secretary of the Department of Health and Human Services, to express their concerns.
Dr. Stephen Grubbs, vice president of clinical affairs at the American Society of Clinical Oncology, was among them. He said Azar told then the new step therapy policy would not have a big impact on cancer treatment.
Patients and their physicians who encounter problems getting specific Part B drugs can appeal using the “process that we have throughout the Medicare Advantage program and Part D plans,” advised Verma.
Under this system, if patients don’t want to follow their insurance plans’ requirements to try a less expensive medication first, they can request an exception to step therapy.
“They need their doctor’s support,” said Francine Chuchanis, director of entitlement rights at Direction Home, an Area Agencies on Aging organization that serves older adults and people with disabilities in northeastern Ohio. The physician must tell the plan why its restrictions should be lifted and provide extensive documentation.
The plans have 24 hours to respond to an expedited exception request and 72 hours for a regular one. During this time, “people are going without their drugs,” said Sarah Jane Blake, a Medicare counselor for New York’s StateWide Senior Action Council.
However, Dr. David Daikh, president of the American College of Rheumatology, said plans frequently do not meet the 72-hour deadline.
“We raised this point with the secretary and his staff,” he said. “They replied that they felt that there would not be a backlog for this program.”
If a plan denies the exemption, patients can file a “reconsideration” appeal. During this process, patients still can’t get their medicine unless they pay for it out-of-pocket.
Only a tiny fraction of Medicare Advantage beneficiaries filed a reconsideration appeal last year. Of the 3,498 cases that were decided, just 1 in 10 beneficiaries won decisions fully or partially in their favor, according to Medicare statistics.
“That’s disheartening to say the least,” said Blake, but she wasn’t surprised. “Beneficiaries are intimidated by the hoops they have to go through and often give up trying to purchase the drugs prescribed for them.”
KHN’s coverage of these topics is supported by
Laura and John Arnold Foundation and
John A. Hartford Foundation
Perhaps no other population is as vulnerable during a hurricane as frail, older adults, especially those who are homebound or living in nursing homes. With Hurricane Florence predicted to slam the North Carolina coast Friday, health officials are already scrambling to keep older residents safe.
Seniors “are not only the most likely to die in hurricanes, but in wildfires and other disasters,” said Dr. Karen DeSalvo, a New Orleans native who served as health commissioner in that city after Hurricane Katrina and went on to be named acting assistant secretary for health at the Department of Health and Human Services for the Obama administration. “The seniors always seem to bear a big brunt of the storms.”
Older people may have a harder time evacuating because they don’t have their own cars or are homebound, said Lauren Sauer, director of operations at the Johns Hopkins Office of Critical Event Preparedness and Response in Baltimore.
In the aftermath of Hurricane Katrina, an analysis of 986 Louisiana residents who died showed the mean age of victims was 69 and nearly two-thirds were older than 65, DeSalvo said. The dead included 70 people who died in nursing facilities during the storm or just after the storm made landfall.
And last year, 12 residents overheated and died at a facility in Hollywood Hills, Fla., in the immediate aftermath of Hurricane Irma, which knocked out the facility’s air conditioning and the temperature climbed to over 95 degrees. The tragedy led Florida to pass legislation requiring nursing homes and assisted living facilities to have backup generators capable of keeping residents cool.
“Unfortunately, the best wake-up call is when a tragedy occurs,” said Dara Lieberman, senior government relations manager at the Trust for America’s Health, a nonprofit. “Hopefully, nursing facilities and emergency managers paid attention to the loss of life in the long-term care facility in Florida last year and realize the risks they face by not preparing. Every facility should have a plan.”
Some studies suggest communities aren’t much better prepared than in the past, however.
A 2018 study from the National Academy of Sciences found that “we are only marginally more prepared to evacuate vulnerable populations now than we were during Hurricane Katrina,” Sauer said.
Deciding whether to stay or go can be more complicated than it sounds, said J.T. Clark of the Near Southwest Preparedness Alliance, a coalition of hospitals and other public health services in southwestern Virginia.
“There is a risk of moving people and there is a risk of staying in place, and you have to weigh those risks,” Clark said.
Evacuations pose a number of dangers for fragile patients, some of whom may need oxygen or intravenous medications, said Sauer. She pointed to a 2017 study that found a sharp increase in mortality among nursing home residents who evacuated because of an emergency, compared with those who sheltered in place.
She noted that leaving a facility is only part of the challenge; it can be equally difficult to find a safe place prepared to house evacuated nursing home residents for days at a time, she said. Clark said that nursing homes once commonly assumed they could simply transfer their residents to local hospitals. But that can impair a hospital’s ability to care for people who need emergency and urgent care, he said.
Many nursing homes in the Carolinas are evacuating residents to areas outside the storm’s direct path.
South Carolina had evacuated 32 nursing homes and assisted-living facilities by Wednesday afternoon, said Randy Lee, president of the South Carolina Health Care Association.
On the Outer Banks of North Carolina, Sentara Healthcare evacuated 65 residents from a nursing home in Currituck to the company’s medical centers in Hampton Roads, Va., spokesman Dale Gauding said.
Source: Centers for Medicare & Medicaid Services, National Weather Service(Caitlin Hillyard/KHN and Lydia Zuraw/KHN)
Hurricane Florence poses risks beyond the coasts, however. Sentara also moved five intensive care patients out of a medical center on the Pasquotank River in Elizabeth City, N.C., because of the risk of flooding. Those patients also went to hospitals in Hampton Roads, Gauding said.
With Norfolk, Va., now expected to escape the brunt of the storm, the 88 residents at the Sentara Nursing Center there are sheltering in place, Gauding said.
Nursing homes in Charleston, S.C., complied with mandatory evacuation orders, said Kimberly Borts, director of communications and charitable giving for Bishop Gadsden retirement community on Charleston’s James Island.
She said the facility conducts annual evacuation drills to continually improve its capability to safely relocate residents and coordinate with the company that provides ambulances.
However, Hurricane Florence’s expected landfall caused a slight change in evacuation plans, which were to be completed by Monday, Borts said. The evacuation had to be delayed until Tuesday because the ambulances were diverted to Myrtle Beach, which remained in Hurricane Florence’s sights.
As of Wednesday afternoon, New Hanover Regional Medical Center in Wilmington, N.C., was directly in the storm’s path. But hospital officials view the building as strong enough to withstand the storm, said spokeswoman Carolyn Fisher. They were less confident about a building housing a skilled nursing facility in Pender County, N.C., whose residents are being moved away from the hurricane’s projected course.
Senior citizens who live at home are also at risk, especially if they lose electricity.
More than 2.5 million Medicare recipients — including 204,000 people in Virginia, North Carolina and South Carolina — rely on home ventilators, oxygen concentrators, intravenous infusion pumps and other electrically powered devices, according to the Centers for Medicare & Medicaid Services. The agency has created a tool called emPOWER 3.0 to help states check up on them.
Patients who lose electricity may need to go to their local emergency room to power their medical equipment, said Mary Blunt, senior vice president at Sentara Healthcare in Norfolk, Va., and interim president of Sentara Norfolk General Hospital. Patients with kidney failure also may need to receive dialysis at the ER if their regular dialysis center is closed, she said.
Virginia, North Carolina and South Carolina will open emergency shelters for people with special medical needs. These facilities provide “limited support,” but not medical care, for people with special needs, according to the South Carolina Emergency Management Division. Residents must bring an adult caregiver to remain with them at all times, according to the South Carolina agency.
Residents should register for these shelters in advance, said DeSalvo, who said that getting people to go can be difficult.
“People do not want to leave their homes,” she said.
Bert Kilpatrick said she’s not concerned about Hurricane Florence and was planning to stay in her house on Charleston’s James Island, where she is just a stone’s throw from the Stono River, a huge tidal estuary that runs to the Atlantic Ocean.
“I’ve been here since 1949. I’m used to these hurricanes,” the 87-year-old said. “Me and my cat, Maybank, we’re staying.”
She even stayed during Hugo, a giant, Category 4 hurricane that devastated Charleston in September 1989. She worked at a downtown hospital then and was there when the storm hit; but her husband, who died recently, rode out Hugo in the house, which was undamaged except for one broken storm window.
Kilpatrick said that as far as she knows all of her nearby neighbors also were staying put. One of those, Patsy Cather, 75, said she and her husband, Joe, were planning to remain. “I’m staying here because he won’t leave.”
She said they might decide to leave later if the storm reports look worse for Charleston. “It’s a no-win situation. You leave, you stay safe; but your home may be gone.”
Databases and registries can help with another challenge: the aftermath of the storm.
“When the wind passes and the water starts going down, they really need to mine the data: Who has ambulatory challenges? Who’s on chemotherapy? Who’s got an opioid dependency?” DeSalvo said.
DeSalvo said she believes the states in the path of Hurricane Florence are in good hands.
“I think the good news is, for a state like South Carolina or North Carolina, they have strong, seasoned leadership in place who are capable of not only managing a complex logistical challenge, but who are good humans,” she said. “It takes both.”
KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
What exactly is sepsis, and why is it so dangerous?
Sepsis happens as the body tries to fight off an infection. The body releases chemicals into the bloodstream to battle the invading germs — which can lead to a severe drop in blood pressure. That can damage vital organs and, in severe cases, cause them to shut down.
That’s known as septic shock, and it can be fatal.
Who is most vulnerable? And what are the signs of sepsis? KHN explains in this video.
KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.
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.
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.
Willie Jackson(Courtesy of Shana Dorsey)
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.
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.
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.”
University of Maryland master’s student Chris Cioffi contributed to this report.
This story was jointly produced by Kaiser Health News and the Chicago Tribune by reporters based in Washington, D.C., and Chicago. Fred Schulte is a senior correspondent for KHN and Elizabeth Lucas is data editor. Joe Mahr is a Tribune reporter.
KHN’s coverage of these topics is supported by
John A. Hartford Foundation,
Gordon and Betty Moore Foundation and
The SCAN Foundation
This week, KHN’s “What the Health?” panelists answered questions submitted by listeners.
Among the topics covered were the origins of coverage in Medicare and Medicaid, telehealth, wellness plans and why doctors get paid the way they do.
This week’s panelists are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Margot Sanger-Katz of The New York Times and Joanne Kenen of Politico. Kaiser Health News will post a transcript of the podcast later.
Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:
Julie Rovner: The New York Times’ “Scotland to Provide Free Sanitary Products to Students,” by Ceylan Yeginsu
Joanne Kenen: The Virginian-Pilot’s “Horrific Deaths, Brutal Treatment: Mental Illness in America’s Jails,” by Gary A. Harki
Margot Sanger-Katz: The New York Times’ “Study Causes Splash But Here’s Why You Should Stay Calm on Alcohol’s Risks,” by Aaron Carroll
Anna Edney: Vox.com’s “Republicans Claimed Medicaid Made the Opioid Epidemic Worse. A New Study Proves Them Wrong,” by German Lopez
To hear all our podcasts, click here.
And subscribe to What the Health? on iTunes, Stitcher or Google Play.
The inspector general at the Department of Health and Human Services this month launched an examination into federal oversight of skilled nursing facilities amid signs some homes aren’t meeting Medicare’s minimum staffing requirements.
The review comes on the heels of a Kaiser Health News and New York Times investigation that found nearly 1,400 nursing homes report having fewer registered nurses on duty than the Centers for Medicare & Medicaid Services (CMS) requires or failed to provide reliable staffing information to the government.
The Office of Inspector General said it would examine the staffing data nursing homes submit to the government through CMS’ new system that uses payroll records. That system gives a more accurate view of staffing than the self-reported numbers facilities had provided for nearly a decade.
The IG said it would also look into how CMS ensured accuracy of the records, enforced minimum staffing requirements and rewarded facilities that exceeded those standards.
Donald White, a spokesman for the inspector general, said the project was “part of our ongoing review of programs at the department.” The report is likely to be issued in the federal fiscal year that begins in October 2019.
KHN’s analysis of the payroll records found thousands of nursing homes had one or more days where the facilities did not report a registered nurse on duty for at least eight hours, as required by Medicare.
KHN also found great volatility in the staffing of certified nursing assistants day to day, with particularly low numbers on weekends. Those aides are crucial to daily care, helping residents eat, bathe and complete other basic activities.
In July, Medicare assigned its lowest staffing rating of one star to nursing homes that did not meet the registered nurse standard, as published on the Nursing Home Compare website. Still, only about half of those homes saw their overall star rating — the most important consumer guide — drop.
CMS declined to comment about the new examination.
Toby Edelman, a senior policy attorney at the Center for Medicare Advocacy, said she hoped the probe would spur CMS to take action against facilities where payroll records show they are leaving residents with insufficient nursing coverage.
“We know registered nurses are critical, and they are finding that they’re not there on weekends,” Edelman said.
Earlier this month, Sen. Ron Wyden (D-Ore.), citing the KHN reporting, asked CMS to explain how it is addressing the issue of nursing homes’ inadequate staffing data or understaffing.
LeadingAge, an association of nonprofit providers of aging services including nearly 2,000 nursing homes, said in response to Wyden’s letter that facilities have complained their data is not showing up correctly on the website and that “kinks” in the new system need to be worked out.
“Even if the report results from a mistake that is immediately corrected, the star is not restored until the next quarterly reporting period,” the group wrote.
KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
Dr. Rob Davidson, an emergency physician from western Michigan, had never considered running for Congress. Then came February 2017. The 46-year-old Democrat found himself at a local town-hall meeting going toe-to-toe with Rep. Bill Huizenga, his Republican congressman of the previous six years.
“I told him about my patients,” Davidson recalled. “I see, every shift, some impact of not having adequate health care, not having dental insurance or a doctor at all.”
His comments triggered cheers from the audience but didn’t seem to register with Huizenga, a vocal Obamacare critic. And that got Davidson thinking.
Dr. Rob Davidson (Courtesy of Rob Davidson’s campaign)
“I’ve always been very upset … about patients who can’t get health care,” he said. But it never inspired him to act. Until this June, that is, when the political novice joined what is now at least eight other Democratic physicians running in races across the country as first-time candidates for Congress.
Democrats hope to gain control of Congress by harnessing what polls show to be voters’ dissatisfaction with both Capitol Hill and President Donald Trump. The president maintains Republican support but registers low approval ratings among Americans overall, according to news organization FiveThirtyEight. Democrats also see promise in candidates such as Davidson, a left-leaning physician who may have a special advantage: firsthand health system experience.
Polls by Quinnipiac University, The Wall Street Journal and the Kaiser Family Foundation suggest health care is among voters’ top concerns as midterm elections approach. (Kaiser Health News is an editorially independent project of the foundation.)
Of the Democratic doctors running for office, all but one are seeking House seats. In addition to the nine newcomers, there are two incumbents up for re-election. Each candidate is campaigning hard on the need to reform the health care system.
And they present a stark contrast to Congress’ current physician makeup.
Twelve of the 14 doctors now in Congress are Republicans. Three are senators. Half of the 14 practice in high-paying specialties such as orthopedic surgery, urology and anesthesiology.
By contrast, these stumping Democratic physicians hail predominantly from specialties such as emergency medicine, pediatrics and internal medicine, though one is a radiologist. They’re fighting to represent a mix of rural, urban and suburban districts.
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“Electing Democratic doctors would certainly change the face of medicine in Congress, and perhaps lend more credence in that body to more liberal health care policies,” said Dr. Matthew Goldenberg, a psychiatrist at Yale School of Medicine who has researched political behavior and advocacy among doctors.
Physicians once trended Republican. The infusion of female and minority doctors, experts said, has changed this. Now, more than 50 percent of party-affiliated doctors are Democrats, and the medical establishment has — following Republican efforts to undo Obamacare — emerged as a staunch defender of the law.
Indeed, many doctor-candidates point to the GOP’s repeal-and-replace efforts as their motivation.
“It’s at a boiling point for many of these physicians,” said Jim Duffett, executive director of the left-leaning Doctors for America, which supports universal health care.
While health care consistently emerges as a top issue, Democrats are more likely to rank it No. 1. For independents and Republicans, though, it’s neck and neck with the economy — and some political analysts question how effective it will be in flipping conservative districts.
“Democrat voters blame Republicans for the problems with health care right now. Republicans blame Democrats. Independents say, ‘A pox on both your houses,’” argued Jim McLaughlin, a Republican pollster working on several 2018 races who has previously worked with Trump. “They’re making a big mistake thinking they can run on [health care].”
That said, doctors can be effective messengers, especially in their communities.
Research suggests Americans hold their own physicians in high regard.
“Voters listen carefully to what physicians have to say about health policy,” said Jonathan Oberlander, a professor of social medicine and health policy at the University of North Carolina. “In a district that’s not so one-sided red or blue, there’s no question that the white coat confers prestige. It’s something physician candidates can speak to with authority.”
Dr. Kyle Horton (Courtesy of Kyle Horton’s campaign)
Davidson, for instance, supports a “Medicare-for-all”-style overhaul, an approach that involves expanding the federal insurance program for seniors and disabled people to all Americans. If elected, he said, he intends to join Democrats’ burgeoning support for a single-payer system, in which the government runs the sole health insurance program, guaranteeing universal coverage. He did not have a primary challenge and is running against Huizenga, the Republican incumbent, in the general election for Michigan’s 2nd Congressional District.
Or there’s Dr. Kyle Horton, an internist running in the North Carolina 7th District. She supports expanding Medicare, by lowering the eligibility age from 65 to 50. She also supports a “public option” health insurance plan sold by the government.
Dr. Hiral Tipirneni (Courtesy of Hiral Tipirneni’s campaign)
Dr. Hiral Tipirneni, an emergency physician in Arizona’s 8th Congressional District, asserts all Americans should be able to buy in to Medicare.
Physicians can have an advantage on other controversial topics, by casting them as public health issues, said Howard Rosenthal, a political scientist at New York University.
Davidson’s campaign, for instance, posts videos on Facebook in which he talks about topics such as health care access and gun violence. One — filmed after an overnight ER shift — has gotten 41,000 views so far.
Also spurring physicians: concerns about abortion access.
Dr. Cathleen London (Courtesy of Kathleen London’s campaign)
Dr. Cathleen London, a Maine doctor, launched her campaign against four-term incumbent GOP Sen. Susan Collins for the 2020 election. She said she had been considering a run, but the upcoming vote for a justice to replace Anthony Kennedy on the Supreme Court — which could have sweeping implications for reproductive health law — pushed her to declare.
“Doctors are really frustrated with Washington, frustrated with the lack of listening to us,” London said.
Many of these Democrats face steep climbs.
Dr. Kim Schrier (Courtesy of Kim Schrier’s campaign)
Of races featuring newcomer physicians, the Cook Political Report, which analyzes elections, rates only Arizona’s 2nd Congressional District as leaning Democratic, and the doctor in that race is just one of seven candidates in the primary. The outcome for Washington’s 8th District, where Dr. Kim Schrier, a pediatrician, is a candidate, is considered a toss-up and a Democratic pickup target.
Tipirneni is the only non-incumbent doctor to have a fundraising advantage so far, according to data from Open Secrets, a nonpartisan, nonprofit project tracking campaign-finance records.
Regardless of electoral results, many observers say the potential implications are sizable — even if few doctors go to Washington.
“They are planting a flag, and they’re going to be raising some important issues — not just health care, but health care is going to be front and center,” said Duffett, from Doctors for America. “That will help change the political debate and political landscape.”
Dr. Michael Holick’s enthusiasm for vitamin D can be fairly described as extreme.
The Boston University endocrinologist, who perhaps more than anyone else is responsible for creating a billion-dollar vitamin D sales and testing juggernaut, elevates his own levels of the stuff with supplements and fortified milk. When he bikes outdoors, he won’t put sunscreen on his limbs. He has written book-length odes to vitamin D, and has warned in multiple scholarly articles about a “vitamin D deficiency pandemic” that explains disease and suboptimal health across the world.
His fixation is so intense that it extends to the dinosaurs. What if the real problem with that asteroid 65 million years ago wasn’t a lack of food, but the weak bones that follow a lack of sunlight? “I sometimes wonder,” Holick has written, “did the dinosaurs die of rickets and osteomalacia?”
Holick’s role in drafting national vitamin D guidelines, and the embrace of his message by mainstream doctors and wellness gurus alike, have helped push supplement sales to $936 million in 2017. That’s a ninefold increase over the previous decade. Lab tests for vitamin D deficiency have spiked, too: Doctors ordered more than 10 million for Medicare patients in 2016, up 547 percent since 2007, at a cost of $365 million. About 1 in 4 adults 60 and older now take vitamin D supplements.
But few of the Americans swept up in the vitamin D craze are likely aware that the industry has sent a lot of money Holick’s way. A Kaiser Health News investigation found that he has used his prominent position in the medical community to promote practices that financially benefit corporations that have given him hundreds of thousands of dollars — including drugmakers, the indoor-tanning industry and one of the country’s largest commercial labs.
In an interview, Holick acknowledged he has worked as a consultant to Quest Diagnostics, which performs vitamin D tests, since 1979. Holick, 72, said that industry funding “doesn’t influence me in terms of talking about the health benefits of vitamin D.”
There is no question that the hormone is important. Without enough of it, bones can become thin, brittle and misshapen, causing a condition called rickets in children and osteomalacia in adults. The issue is how much vitamin D is healthy, and what level constitutes deficiency.
Holick’s crucial role in shaping that debate occurred in 2011. Late the previous year, the prestigious National Academy of Medicine (then known as the Institute of Medicine), a group of independent scientific experts, issued a comprehensive, 1,132-page report on vitamin D deficiency. It concluded that the vast majority of Americans get plenty of the hormone through diet and sunlight, and advised doctors to test only patients at high risk of vitamin D-related disorders, such as osteoporosis.
A few months later, in June 2011, Holick oversaw the publication of a report that took a starkly different view. The paper, in the peer-reviewed Journal of Clinical Endocrinology & Metabolism, was on behalf of the Endocrine Society, the field’s foremost professional group, whose guidelines are widely used by hospitals, physicians and commercial labs nationwide, including Quest. The society adopted Holick’s position that “vitamin D deficiency is very common in all age groups” and advocated a huge expansion of vitamin D testing, targeting more than half the United States population, including those who are black, Hispanic or obese — groups that tend to have lower vitamin D levels than others.
The recommendations were a financial windfall for the vitamin D industry. By advocating such widespread testing, the Endocrine Society directed more business to Quest and other commercial labs. Vitamin D tests are now the fifth-most-common lab test covered by Medicare.
The guidelines benefited the vitamin D industry in another important way. Unlike the National Academy, which concluded that patients have sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter, the Endocrine Society said vitamin D levels need to be much higher — at least 30 nanograms per milliliter. Many commercial labs, including Quest and LabCorp, adopted the higher standard.
Yet there’s no evidence that people with the higher level are any healthier than those with the lower level, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute and co-author of the National Academy report. Using the Endocrine Society’s higher standard creates the appearance of an epidemic, he said, because it labels 80 percent of Americans as having inadequate vitamin D.
“We see people being tested all the time and being treated based on a lot of wishful thinking, that you can take a supplement to be healthier,” Rosen said.
Patients with low vitamin D levels are often prescribed supplements and instructed to get checked again in a few months, said Dr. Alex Krist, a family physician and vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. Many physicians then repeat the test once a year. For labs, “it’s in their financial interest” to label patients with low vitamin D levels, Krist said.
In a 2010 book, “The Vitamin D Solution,” Holick gave readers tips to encourage them to get their blood tested. For readers worried about potential out-of-pocket costs for vitamin D tests — they range from $40 to $225 — Holick listed the precise reimbursement codes that doctors should use when requesting insurance coverage. “If they use the wrong coding when submitting the claim to the insurance company, they won’t get reimbursed and you will wind up having to pay for the test,” Holick wrote.
Holick acknowledged financial ties with Quest and other companies in the financial disclosure statement published with the Endocrine Society guidelines. In an interview, he said that working for Quest for four decades — he is currently paid $1,000 a month — hasn’t affected his medical advice. “I don’t get any additional money if they sell one test or 1 billion,” Holick said.
A Quest spokeswoman, Wendy Bost, said the company seeks the advice of a number of expert consultants. “We feel strongly that being able to work with the top experts in the field, whether it’s vitamin D or another area, translates to better quality and better information, both for our patients and physicians,” Bost said.
Since 2011, Holick’s advocacy has been embraced by the wellness-industrial complex. Gwyneth Paltrow’s website, Goop, cites his writing. Dr. Mehmet Oz has described vitamin D as “the No. 1 thing you need more of,” telling his audience that it can help them avoid heart disease, depression, weight gain, memory loss and cancer. And Oprah Winfrey’s website tells readers that “knowing your vitamin D levels might save your life.” Mainstream doctors have pushed the hormone, including Dr. Walter Willett, a widely respected professor at Harvard Medical School.
Today, seven years after the dueling academic findings, the leaders of the National Academy report are struggling to be heard above the clamor for more sunshine pills.
“There isn’t a ‘pandemic,’” A. Catharine Ross, a professor at Penn State and chair of the committee that wrote the report, said in an interview. “There isn’t a widespread problem.”
Ties To Drugmakers And Tanning Salons
In “The Vitamin D Solution,” Holick describes his promotion of vitamin D as a lonely crusade. “Drug companies can sell fear,” he writes, “but they can’t sell sunlight, so there’s no promotion of the sun’s health benefits.”
Yet Holick also has extensive financial ties to the pharmaceutical industry. He received nearly $163,000 from 2013 to 2017 from pharmaceutical companies, according to Medicare’s Open Payments database, which tracks payments from drug and device manufacturers. The companies paying him included Sanofi-Aventis, which markets vitamin D supplements; Shire, which makes drugs for hormonal disorders that are given with vitamin D; Amgen, which makes an osteoporosis treatment; and Roche Diagnostics and Quidel Corp., which both make vitamin D tests.
The database includes only payments made since 2013, but Holick’s record of being compensated by drug companies started before that. In his 2010 book, he describes visiting South Africa to give “talks for a pharmaceutical company,” whose president and chief executive were in the audience.
Holick’s ties to the tanning industry also have drawn scrutiny. Although Holick said he doesn’t advocate tanning, he has described tanning beds as a “recommended source” of vitamin D “when used in moderation.”
Dr. Michael Holick has described tanning beds — which the International Agency for Research on Cancer has since classified as carcinogenic — as a “recommended source” of vitamin D “when used in moderation.”(Rick Friedman/Corbis via Getty Images)
Holick has acknowledged accepting research money from the UV Foundation — a nonprofit arm of the now-defunct Indoor Tanning Association — which gave $150,000 to Boston University from 2004 to 2006, earmarked for Holick’s research. The International Agency for Research on Cancer classified tanning beds as carcinogenic in 2009.
In 2004, the tanning-industry associations led Dr. Barbara Gilchrest, who then was head of Boston University’s dermatology department, to ask Holick to resign from the department. He did so, but remains a professor at the medical school’s department of endocrinology, diabetes and nutrition and weight management.
In “The Vitamin D Solution,” Holick wrote that he was “forced” to give up his position due to his “stalwart support of sensible sun exposure.” He added, “Shame on me for challenging one of the dogmas of dermatology.”
Although Holick’s website lists him as a member of the American Academy of Dermatology, an academy spokeswoman, Amanda Jacobs, said he was not a current member.
Dr. Christopher McCartney, chairman of the Endocrine Society’s clinical guidelines subcommittee, said the society has put in place stricter policies on conflict of interest since its vitamin D guidelines were released. The society’s current policies would not allow the chairman of the guideline-writing committee to have financial conflicts.
A Miracle Pill Loses Its Luster
Enthusiasm for vitamin D among medical experts has dimmed in recent years, as rigorous clinical trials have failed to confirm the benefits suggested by early, preliminary studies. A string of trials found no evidence that vitamin D reduces the risk of cancer, heart disease or falls in the elderly. And most scientists say there isn’t enough evidence to know if vitamin D can prevent chronic diseases that aren’t related to bones.
Although the amount of vitamin D in a typical daily supplement is generally considered safe, it is possible to take too much. In 2015, an article in the American Journal of Medicine linked blood levels as low as 50 nanograms per milliliter with an increased risk of death.
Some researchers say vitamin D may never have been the miracle pill that it appeared to be. Sick people who stay indoors tend to have low vitamin D levels; their poor health is likely the cause of their low vitamin D levels, not the other way around, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Boston. Only really rigorous studies, which randomly assign some patients to take vitamin D and others to take placebos, can provide definitive answers about vitamin D and health. Manson is leading one such study, involving 26,000 adults, expected to be published in November.
A number of insurers and health experts have begun to view widespread vitamin D testing as unnecessary and expensive. In 2014, the U.S. Preventive Services Task Force said there wasn’t enough evidence to recommend for or against routine vitamin D screening. In April, the task force explicitly recommended that older adults outside of nursing homes avoid taking vitamin D supplements to prevent falls.
In 2015, Excellus BlueCross BlueShield published an analysis highlighting the overuse of vitamin D tests. In 2014, the insurer spent $33 million on 641,000 vitamin D tests. “That’s an astronomical amount of money,” said Dr. Richard Lockwood, Excellus’ vice president and chief medical officer for utilization management. More than 40 percent of Excellus patients tested had no medical reason to be screened.
In spite of Excellus’ efforts to rein in the tests, vitamin D usage has remained high, Lockwood said. “It’s very hard to change habits,” he said, adding: “The medical community is not much different than the rest of the world, and we get into fads.”
KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.
BALTIMORE — When Medicare in 2011 agreed to pay for a revolutionary procedure to replace leaky heart valves by snaking a synthetic replacement up through blood vessels, the goal was to offer relief to the tens of thousands of patients too frail to endure open-heart surgery, the gold standard.
To help ensure good results, federal officials limited Medicare payment only to hospitals that serve large numbers of cardiac patients.
The strategy worked. In the past seven years, more than 135,000 mostly elderly patients have undergone transcatheter aortic valve replacement, known as TAVR. And TAVR’s in-hospital mortality rate has dropped by two-thirds, to 1.5 percent.
Now, in a campaign motivated by a muddy mix of health care and business, smaller hospitals and the medical device industry are arguing that the technique should be more widely deployed. They note only about half of the nearly 1,100 hospitals offering surgical valve replacement can do TAVR. And they say current limitations discriminate against minorities and people in rural areas, forcing patients to undergo a riskier and significantly more invasive treatment — or miss getting a new valve altogether.
Hospitals that already have a TAVR franchise are fighting to stifle new competitors, saying programs that don’t do enough procedures would not provide high-quality care.
At stake is the care of thousands of patients. Half of the more than 250,000 Americans estimated each year to develop severe aortic valve stenosis — narrowing of the valve that regulates the flow of blood from the heart to the largest artery of the body — die within two years. Getting an artificial heart valve lowers that death rate to as low as 17 percent, studies show.
Also at stake is the $45,000 Medicare pays hospitals for each TAVR case — excluding the doctor’s fee. While hospitals typically make only a small profit on the procedure — partly because the device costs more than $30,000 — they benefit because each TAVR patient typically needs other cardiac services and tests that can boost the hospital’s bottom line.
In addition, offering TAVR carries a cachet that helps recruit and retain top specialists, who bring in more patients.
At a Medicare advisory committee hearing in Baltimore on July 25, both sides of the debate emphasized how they were seeking to help patients. But the economics of TAVR was ever-present given the horde of medical device and hospital officials and industry analysts in the audience.
The committee split on the issue, although a majority of members backed the continued use of volume requirements. The Centers for Medicare & Medicaid Services is expected to decide later this year whether to change its patient volume minimum for TAVR.
Dr. Jason Felger, a heart surgeon who wants his community hospital in San Angelo, Texas, to offer the procedure, said behind the fight over TAVR is protecting profit and revenue. He refers patients to hospitals more than three hours away for the procedure or, if they aren’t willing to travel, they risk their lives to undergo the conventional operation.
Hospitals that offer TAVR, he said, aren’t willing to give up the referrals they now rely on from other hospitals.
“It’s all about the money,” he said.
Improving A Hospital’s Reputation
Unlike open-heart surgery, in which the chest is cracked open to remove the unhealthy valve, TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve. The old valve remains but is pushed aside, and the new one takes over its work.
With this less invasive valve procedure, people can get out of the hospital within two or three days and get back to daily activities much sooner than with open-heart surgery, which typically has a six-week recovery time.
TAVR has been approved by the Food and Drug Administration for people who cannot have open-heart surgery or for whom it would be risky. These include the elderly and frail and people with complications such as kidney and lung disease. But TAVR use has expanded among younger, and less sick, patients in recent years. Within the next year, the FDA is likely to approve the procedure for all patients needing a new aortic valve, industry analysts say.
TAVR does carry risks, including stroke. Patients may also need a pacemaker after the procedure to regulate heart rhythm.
TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve.(Courtesy of Edwards Lifesciences Corp.)
The large majority of patients getting TAVR are 65 and over. The importance of Medicare’s blessing goes beyond its payments, since private insurers typically follow Medicare standards. Physicians seeking to expand use of TAVR point out that Medicare has no volume requirements for other major cardiac procedures.
The two largest TAVR medical device companies are divided on the issue. Edwards Lifesciences Corp. of Irvine, Calif., supports eliminating the minimum-patient requirements, while Minneapolis-based Medtronic favors keeping the status quo. The Advanced Medical Technology Association, or AdvaMed, an industry trade group, also supports the change.
About 50,000 patients are expected to have TAVR this year, and those numbers are forecast to double by 2020, according to American College of Cardiology and other major heart groups.
When Michael Vigil, 50, needed TAVR in May, he drove more than three hours from his home in eastern Wyoming to a hospital in Denver. Before the procedure, the oil-drilling contractor was constantly tired and out of breath — even after mundane chores at home. Vigil’s aortic valve had been damaged from radiation treatments for non-Hodgkin lymphoma decades before.
Vigil was sent home a day after the TAVR procedure. He was back at work the following week.
He said he felt more energized almost immediately after having the procedure.
“It’s worked so well, my wife wishes they dialed it back a little,” Vigil said.
Donnette Smith, president of the patient advocacy group Mended Hearts, said many patients don’t have good access to the procedure.
“Patients do not know of this option unless they walk through the right door of the right hospital,” said Smith of Huntsville, Ala. She had heart valve surgery in 1988.
Mended Hearts receives funding from device makers.
To gain Medicare approval for TAVR programs, hospitals have to perform annually 50 open-heart valve repairs, 400 angioplasties and 1,000 cardiac catheterizations — a procedure in which medical teams use skills similar to those needed for TAVR.
Doctors at larger hospitals say procedure volume is a good predictor for success. The American College of Cardiology and the Society of Thoracic Surgeons recommend hospitals be able to do at least 50 TAVRs each year within two years of startup. More than three-quarters of the 582 hospitals authorized by Medicare for TAVR meet that standard.
“Whether it’s playing the violin or performing heart surgery, experience matters,” said Dr. Thoralf Sundt, chief of cardiac surgery at Massachusetts General Hospital.
Dr. Ashish Pershad, an interventional cardiologist who performs TAVR at Banner Medical Center in Phoenix, agreed that there are access issues. But he said it’s not because of a lack of programs. Rather, he said, surgeons too often don’t refer patients for it because they make more money from doing the open-heart surgical valve replacement.
“Patients are missing out on this procedure because they are not being referred, and primary care doctors lack knowledge about it,” he said.
Expanding Treatment Options
Doctors seeking a Medicare rule to widen access say there is little evidence hospitals that perform more TAVRs have lower mortality rates. As long as they can show low mortality and complications, they believe their hospitals should be able to offer the service.
“Our intention is not to lower the quality of outcomes by expanding to ‘low volume’ centers; but to provide excellent care to a larger population of patients,” Felger and his colleagues at Shannon Medical Center in San Angelo, Texas, wrote to the CMS advisory group.
Last year, Felger said, he sent a dozen patients to hospitals in Austin or Dallas for TAVR, while eight other patients opted for the open-heart surgery.
“I have patients tell me they would rather have the surgical procedure at their local hospital than traveling to another city,” he said. “They tell me ‘Let’s do this; if I die, I die.’”
KHN’s coverage of these topics is supported by
John A. Hartford Foundation and
Gordon and Betty Moore Foundation
Did you know that about 1 million Americans go to the hospital with pneumonia every year? Pneumonia is a lung infection caused by pneumococcal disease, which can also cause blood infections and meningitis. The bacteria that causes pneumococcal disease spreads by direct person-to-person contact. There’s a vaccine to help prevent pneumonia, but only 67% of adults 65 and over have ever gotten it.
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Have cochlear implants or cerebrospinal fluid (CSF) leaks
Learn more about Medicare-covered vaccines by watching our video. Protect yourself from pneumonia—get your pneumococcal shot today.