The government acknowledges that the change would lead to fewer people with limited English skills accessing healthcare and fewer reports of discrimination.
This article was first published on Monday, June 24, 2019 in Kaiser Health News.
A federal regulation demands that certain healthcare organizations provide patients who have limited English skills a written notice of free translation services.
But the Trump administration wants to ease those regulations and also no longer require that directions be given to patients on how they can report discrimination they experience.
The changes could save $3.16 billion over five years for the healthcare industry, according to the administration.
The proposal would not change the government's requirements that insurers and medical facilities provide foreign language translators and interpreters for non-English speakers.
The government acknowledged in the proposal that the change would lead to fewer people with limited English skills accessing healthcare and fewer reports of discrimination. But it also questioned the need for these notices, pointing out that in some areas health organizations spend money to accommodate a small contingent of language speakers. For example, notices in Wyoming must account for the 40 Gujarati speakers — a language of India — in the state.
In all, the government said, the impact of doing away with these requirements would be "negligible."
Others disagree.
"I haven't seen any reason to believe that this will only have a negligible impact," said Mara Youdelman, managing attorney for the Washington, D.C., office of the National Health Law Program, a civil rights advocacy group. She said it "will likely result in people just not knowing their rights but not accessing care to which they’re eligible."
Regulations under Section 1557 of the Affordable Care Act require insurers, hospitals and others to include a "tagline" of free translation services for the 15 languages that are most prevalent in a state. Additionally, it requires a nondiscrimination clause and directions on how to file a complaint with the Department of Health and Human Services Office for Civil Rights.
This information must be posted on websites, in physical spaces and in "significant communications" to the patient. But the ambiguity of that phrase prompted healthcare organizations to post the required information on numerous pieces of material — such as a separate page about language options sent with each Explanation of Benefits statement from an insurer. Together, these efforts cost organizations billions of dollars.
"No one realized exactly what that definition of 'significant communication' — how much would be wrapped up in that," said Katie Keith, a Georgetown University professor who specializes in the ACA.
An estimated 25.9 million people in the United States in 2017 had limited English proficiency, the Census Bureau reported. Patients facing language barriers have a higher risk of health care complications, such as surgical infections and falls, because they may misunderstand a doctor’s orders, make mistakes preparing for procedures or improperly use medications.
In this latest proposal, however, the federal government questions whether the written notices are needed. The majority of enrollees speak English — census data from 2017 showed that 91.5% of people over age 5 spoke only English at home or spoke the language "very well." In certain states, the proposal claims, every enrollee receives a notice for translation services in a language that only a few dozen people speak in the area.
Other state and federal laws protect the rights of patients with limited language services, the proposed rule says. It also cites evidence of some enrollees not liking the extra forms and being less inclined to open their mail because of them.
"These complaints make us concerned that the Section 1557 Regulation has resulted in 'cognitive overload,'" the document stated, "such that individuals experience a diminished ability to process information" because of the additional paperwork.
Anecdotal reports cited by the government also point out that the notices did not significantly increase the number of patients using language services and reporting complaints. However, the proposed rule also estimates at least 90% of hospitals and physicians were not complying with the requirements.
Youdelman admitted she does not have concrete data showing that these taglines translate to increased access to services. However, she added, removing them wholesale without a promise to prevent discrimination in a different way is also counterproductive.
"Eliminating taglines is not the correct solution," Youdelman said. "There is a way to inform folks while being cost-conscious."
Health insurers and pharmacy benefit managers' reactions to the proposed change have been tepid. The Pharmaceutical Care Management Association — the trade organization for pharmacy benefit managers — said in an email it "believes all consumers should be informed regarding translation services." America’s Health Insurance Plans, the trade association for health insurers, said in an email that insurers would make sure consumers get the support they need to understand information — "including providing phone interpreters and written translations for customers who need them."
Keith said that if the proposal is finalized more patients would not understand information involving their health. Some of these details on insurance and billing documents are already difficult for native English speakers to dereplacecipher and could be a challenge for less fluent people.
"Anytime you’re not notifying people of their rights," Youdelman said, "you disempower them."
As opioid addiction and deadly overdoses escalated into an epidemic across the U.S., thousands of surgeons continued to hand out far more pills than needed for postoperative pain relief, according to a KHN-Johns Hopkins analysis of Medicare data.
Many doctors wrote prescriptions for dozens of opioid tablets after surgeries — even for operations that cause most patients relatively little pain, according to the analysis, done in collaboration with researchers at Johns Hopkins School of Public Health. It examined almost 350,000 prescriptions written for patients operated on by nearly 20,000 surgeons from 2011 to 2016 — the latest year for which data are available.
Some surgeons wrote prescriptions for more than 100 opioid pills in the week following the surgery. The total amounts often exceeded current guidelines from several academic medical centers, which call for zero to 10 pills for many of the procedures in the analysis, and up to 30 for coronary bypass surgery.
While hundreds of state and local lawsuits have been filed against opioid manufacturers, claiming they engaged in aggressive and misleading marketing of these addictive drugs, the role of physicians in contributing to a national tragedy has received less scrutiny. Research shows that a significant portion of people who become addicted to opioids started with a prescription after surgery.
In 2016, opioids of all kinds were linked to 42,249 deaths, up from the 33,091 reported in 2015. The opioid-related death rate jumped nearly 28% from the year before, according to the CDC.
Yet long-ingrained and freewheeling prescribing patterns changed little over the six years analyzed. KHN and Johns Hopkins examined the prescribing habits of all U.S. surgeons who frequently perform seven common surgical procedures and found that in the first week after surgery:
Coronary artery bypass patients operated on by the highest-prescribing 1% of surgeons filled prescriptions in 2016 exceeding an average of 105 opioid pills.
Patients undergoing a far less painful procedure — a lumpectomy to remove a breast tumor — were given an average of 26 pills in 2016 the week after surgery. The highest-prescribing 5% of surgeons prescribed 40 to 70 pills on average.
Some knee surgery patients took home more than 100 pills in the week following their surgery.
Those amounts — each "pill" in the analysis was the equivalent of 5 milligrams of oxycodone — are many times what is currently recommended by some physician groups to relieve acute pain, which occurs as a result of surgery, accident or injury. The analysis included only patients not prescribed opioids in the year before their operation.
"Prescribers should have known better" based on studies and other information available at the time, said Andrew Kolodny, co-director of opioid policy research at Brandeis University and director of the advocacy group Physicians for Responsible Opioid Prescribing.
While the dataset included only prescriptions written for patients on Medicare, the findings may well understate the depth of the problem, since doctors are more hesitant to give older patients the powerful painkillers because of their sedating side effects.
Surgeons’ prescribing habits are significant because studies show that 6% of patients who are prescribed opioids after surgery will still be taking them three to six months later, having become dependent. The likelihood of persistent use rises with the number of pills and the length of time opioids are taken during recuperation.
Also, unused pills in medicine cabinets can make their way onto the street.
Dr. Marty Makary, a surgical oncologist at Johns Hopkins, admits that he too once handed out opioids liberally. Now he is marshaling a campaign to get surgeons to use these powerful painkillers more consciously and sparingly. "I think there's an 'aha' moment that many of us in medicine have had or need to have," he said.
But old habits are hard to kick.
KHN contacted dozens of the surgeons who topped the ranks of opioid prescribers in the 2016 database. They hailed from small, community hospitals as well as major academic medical centers. The majority declined to comment, some bristling when questioned.
Some of those surgeons were critical of the analysis, saying it didn't take into account certain essential factors. For example, it was not possible to determine whether patients had complications or needed higher amounts of pain medication for another reason. And some surgeons had only a handful of patients who filled prescriptions, making for a small sample size.
But surgeons also indicated that the way they prescribe pain pills was less than intentional. It was sometimes an outgrowth of computer programs that default to preset amounts following procedures, or practice habits developed before the opioid crisis. Additionally, they blame efforts in the late 1990s and early 2000s that encouraged doctors and hospitals to consider pain as "the fifth vital sign." A major hospital accrediting group required providers to ask patients how well their pain was treated. Pharmaceutical companies used the fifth vital sign campaign as a way to promote their opioid treatments.
Makary, who oversaw the analysis of the Medicare dataset, said that, while opioid prescribing is slowly dropping, to date many surgeons have not paid enough attention to the problem or responded with sufficient urgency.
Dr. Audrey Garrett, an oncologic surgeon in Oregon, said she was "surprised" to hear that she was among the top tier of prescribers. She said she planned to re-evaluate her clinic's automated prescribing program, which is set to order specific amounts of opioids.
KHN will analyze data for 2017 and subsequent years when it becomes available to follow how prescribing is changing.
The analysis examined prescribing habits after seven common procedures: coronary artery bypass, minimally invasive gallbladder removal, lumpectomy, meniscectomy (which removes part of a torn meniscus in the knee), minimally invasive hysterectomy, open colectomy and prostatectomy.
Across the board, the analysis showed that physicians gave a large number of narcotics when fewer pills or alternative medications, including over-the-counter pain relief tablets, could be equally effective, according to recent guidelines from Makary and other academic researchers.
On average, from 2011 to 2016, Medicare patients in the analysis took home 48 pills in the week following coronary artery bypass; 31 following laparoscopic gallbladder removal; 28 after a lumpectomy; 41 after meniscectomy; 34 after minimally invasive hysterectomy; 34 after open colon surgery; and 33 after prostatectomy.
According to post-surgical guidelines spearheaded by Makary for his hospital last year, those surgeries should require at most 30 pills for bypass; 10 pills for minimally invasive gallbladder removal, lumpectomy, minimally invasive hysterectomy and prostatectomy; and eight pills for knee surgery. It has not yet published a guideline for open colon surgery.
The Johns Hopkins' doctors developed their own standards because of a dearth of national guidelines for post-surgical opioids. They arrived at those figures after reaching a consensus among surgeons, nurses, patients and other medical staff on how many pills were needed after particular surgeries.
Hoping to reduce overprescribing, Makary is preparing to send letters next month to surgeons around the country who are among the highest opioid prescribers under a grant he received from the Arnold Foundation, a nonprofit group whose focus includes drug price issues. (Kaiser Health News also received funding from the Arnold Foundation.)
Even if the prescription numbers have fallen since 2016, the amounts given today are likely still excessive.
"When prescribing may have been five to 20 times too high, even a reduction that is quite meaningful still likely reflects overprescribing," said Dr. Chad Brummett, an anesthesiologist and associate professor at the University of Michigan.
Brummett is also co-director of the Michigan Opioid Prescribing Engagement Network, a collaboration of physicians that makessurgery-specific recommendations, many of them in the 10- to 20-pill range.
"Reducing unnecessary exposure is key to reducing the risk of new addiction," said former Food and Drug Administration commissioner Scott Gottlieb. In August 2018, when Gottlieb was at the agency's helm, it commissioned a report from the National Academy of Sciences on how best to set opioid prescribing guidelines for acute pain from specific conditions or surgical procedures. Its findings are expected later this year.
"There are still too many 30-tablet prescriptions being written," said Gottlieb.
Healers Sowing Disease?
Naturally, surgeons rankle at the idea that they played a role in the opioid epidemic. But studies raise serious concerns.
Transplant surgeon Dr. Michael Engelsbe, director of the Michigan Surgical Quality Collaborative, points to the study showing 6% of post-op patients who get opioids for pain develop long-term dependence. That means a surgeon who does 300 operations a year paves the way for 18 newly dependent people, he said.
Many patients do not need the amounts prescribed.
Intermountain Healthcare, a not-for-profit system of hospitals, clinics, and doctors in Utah, began surveying patients two years ago to find out how much of their prescribed supply of opioids they actually took following surgery.
"Globally, we were overprescribing by 50%," said Dr. David Hasleton, senior medical director.
But Intermountain approached individual doctors carefully. "If you go to a prescriber to say, 'You are overprescribing,' it never goes well. A common reaction is, 'Your data is wrong' or 'My patients are different than his,'" said Hasleton.
For the analysis, KHN attempted to contact more than 50 surgeons whose 2016 numbers ranked them among the top prescribers in each surgical category.
One who did agree to speak was Dr. Daniel J. Waters, who 13 years ago had his chest cut open to remove a tumor, an operation technically similar to what he does for a living: coronary artery bypass.
"So I have both the doctor perspective and the patient perspective," said Waters, who practices in Mason City, Iowa.
In 2016, Waters' Medicare bypass patients who filled their prescriptions took home an average of nearly 157 pills each, according to the KHN-Johns Hopkins analysis.
"When I went home from the hospital, 30 would not have been enough," said Waters of the number recommended by the Hopkins team for that surgery.
But he said he has recently curbed his prescribing to 84 pills.
Nationally, the average prescription filled for a coronary artery bypass was 49 pills in 2016 and had changed little since 2011, the analysis shows.
Others who spoke with KHN said they had developed the habit of prescribing copiously — sometimes giving out multiple opioid prescriptions — because they didn't want patients to get stuck far from the office or over a weekend with pain or because they were trying to avoid calls from dissatisfied, hurting patients.
In the KHN-Johns Hopkins data, the seven patients of Dr. Antonio Santillan-Gomez who filled opioid prescriptions after minimally invasive hysterectomies in 2016 received an average of 77 pills each.
A gynecologic oncologist, Santillan-Gomez said: "I'm in San Antonio, and some of my patients come from Laredo or Corpus Christi, so they would have to drive two to three hours for a prescription."
Still, he said, since e-prescribing of opioids became more widespread in the past few years, he and other surgeons in his group have limited prescriptions to 20 to 30 pills and encouraged patients to take Tylenol or other over-the-counter medications if they run out. E-prescribing can not only help track patients getting opioids but also reduce the problem of patients having to drive back to the office to get a written prescription.
Dr. Janet Grange, a breast surgeon in Omaha, Neb., said that in her experience, opioid dependence had not been a problem.
"I can absolutely tell you I don't have even 1% who become long-term opioid users," said Grange.
The analysis showed that Grange had 12 opioid-naïve Medicare patients who had a lumpectomy in 2016. Eight of them filled prescriptions for an average of 47 pills per patient.
She called Johns Hopkins' zero-to-10-pill pain-control recommendation following that procedure "miserly."
The Pendulum Swings
Some of the higher-prescribing surgeons in the KHN-Johns Hopkins analysis reflected on their potential contribution to a national catastrophe and are changing their practice.
"That is a shocking number," said oncologist Garrett, speaking of the finding that 6% of patients who go home with opioids will become dependent. "If it's true, it’s something we need to educate physicians on much earlier in their medical careers."
Garrett, in Eugene, Ore., said she has cut back on the number of pills she gives patients since 2016. The KHN-Johns Hopkins analysis showed that seven of her 13 opioid-naïve Medicare patients undergoing minimally invasive hysterectomies filled a prescription for opioids in 2016. Those patients took home an average of 76 pills each.
Johns Hopkins guidelines call for no more than 10 opioid pills following this procedure, while Brummett's Michigan network recommends no more than 15.
Surgeon and researcher Dr. Richard Barth, once a heavy prescriber himself, said that his own experience convinced him that physicians' preconceptions about how much pain relief is needed are often way off.
The analysis showed his lumpectomy patients in 2013 filled an average of 33 pills in the week after surgery. By 2016, that average had dropped to seven pills. Many patients, he said, can do just fine after lumpectomy with over-the-counter medications — and often no opioids at all.
The key, he said, is to set patients' expectations upfront.
"I tell them it's OK to have a little discomfort, that we're not trying to get to zero pain," said Barth, who is chief of general surgery at Dartmouth-Hitchcock Medical Center and has published extensively on opioid prescribing.
After lumpectomy, "what I recommend is Tylenol and ibuprofen for at least a few days and to use the opioids only if the discomfort isn't relieved by those."
Indeed, the data analysis showed that a significant number of patients given prescriptions for opioids never filled them because they don’t need that level of pain relief.
Between 2011 and 2016, for example, only 62% of lumpectomy patients in the analysis filled prescriptions, similar to hysterectomy patients.
In 2016, patients of Dr. Kimberli Cox, a surgeon in Peoria, Ariz., were prescribed about 59 pills in the week following lumpectomy, well above the recommendations from both Johns Hopkins and others.
But the KHN-Johns Hopkins analysis of that year’s data shows that half of her patients never filled a painkiller prescription — a fact she acknowledges has changed her thinking.
"I am now starting to prescribe less because many patients say, 'You gave me too many' or 'I didn’t fill it," she said.
A Midwestern grocery chain, Hy-Vee, is taking an unusual—and highly controversial—approach to reducing health care costs.
Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider. Hy-Vee has contracted with one of the United States' leading stem cell companies—Regenexx, based in Des Moines, Iowa—that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.
Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery. A single knee replacement, for example, ranges from $19,000 to $30,000 in the U.S.
The benefits of stem cells are hotly debated in the medical community, and federal regulators have warned the public to beware of clinics that peddle unapproved injections as a cure-all. Many doctors and ethicists say they fear the public is being misled about how well stem cells work—and whether the procedures save their money or waste it.
"This definitely is not a high-quality, proven treatment," said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center.
So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren't part of a standard insurance package. Over half of U.S. workers insured through their jobs belong to such plans, according to the Employee Benefit Research Institute, a D.C.-based nonprofit.
Perhaps Regenexx's best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens. (Meredith owned Time magazine until September 2018.)
In a statement, Regenexx said its goal is to "replace more invasive surgical orthopedics" with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures "repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments." In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient's hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a "platelet-rich plasma" treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.
Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors. Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics, who has published a series of articles describing the stem cell market.
At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures. Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.
Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than "minimal manipulation."
On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy. Regenexx says it tries to be transparent about its results, noting that it posts data on patient results. In a statement, the company said most patients it treats for knee pain have good functioning five years later.
"There is zero evidence that you can replace 70% of surgeries with stem cells," he said.
Recent research suggests stem cells and platelets may work no better than placebos, Fu added. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections, writes Dr. Benjamin Rothrauff, a postdoctoral fellow who works with Fu at the University of Pittsburgh.
There's also no definitive evidence stem cells and platelets can regrow lost cartilage, Fu said. A 2018 review concluded platelets have "marginal effectiveness," and experts note that most published studies are so small or poorly designed that their results aren't reliable.
Is Regenexx Actually Saving Employers Money?
If Regenexx treatments worked as well as the company claims, insurance companies would rush to cover them, Turner said. But the notion that Regenexx will save employers money hasn't been proven and is "a boastful claim with no clinical merit," said Henry Garlich, director of health care value solutions and enhanced clinical programs at Blue Shield of California, who has reviewed Regenexx's publications.
"The problem is that we don't have enough data. When a company does not have this type of evidence, then they will go direct to the consumer market," Garlich said. "Some vulnerable individuals, including companies that want to reduce their health care costs, may buy what they're selling." If Regenexx procedures don't work, Garlich said, an employer could end up paying twice—once for stem cells and once for knee replacement.
Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn't sold.
"My experience with them has not been great, in terms of marketing and sales. They're very, very pushy," McKay said. "They claim they can get people back to work earlier" than surgery. "But if I still need knee surgery a year down the road, that doesn't cut my costs."
The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers' compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn't included Regenexx in its health plan.
McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another "went through a couple procedures and ended up needing surgery anyway."
Corporate executives have become some of Regenexx's biggest boosters. Hy-Vee's former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, "I knew that giving our employees the chance to explore options besides surgery was in their best interest."
Hy-Vee did not make Jurgens or other employees available to interview.
Steve Lacy, Meredith's former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try. The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. "The rehab and recovery is far less onerous" with the Regenexx procedure than with surgery, Lacy said. "If the procedure doesn't work for an individual, there's no harm."
Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That's a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.
At its headquarters, Meredith has promoted Regenexx procedures through email, posters and "lunch-and-learn" sessions in the office, said Jenny McCoy, Meredith's corporate communications director.
McCoy herself has become a poster child for Regenexx's benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site. Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.
"I thought, 'If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,'" said McCoy, 52. Given the price tag, she said, "I would not have done it otherwise. I wouldn't have even known about it." In the Regenexx marketing video, Lacy is shown saying stem cells saved Meredith roughly $700,000 in one year. Lacy said he estimated that number by comparing what Meredith spent on Regenexx with what it would have spent on hip and knee replacements.
But Slusark said Meredith hasn't examined employee medical records to determine how many were eligible for surgery or how many needed joint surgery after trying Regenexx. "We don't spend a lot of time calculating savings," Slusark said.
Without that medical information, Meredith can't accurately estimate how much money it saved, if any, Fu said. He noted that relatively few people with joint pain undergo surgery, which doctors typically view as a last resort for patients who have exhausted all other treatment options. Although 14 million Americans have knee arthritis, the Arthritis Foundation estimates that doctors perform only about 757,000 knee replacements each year.
Before recommending joint replacement, doctors often tell patients to try exercise, physical therapy, weight loss, supportive shoe inserts or steroid injections, Garlich said. Physical therapy, in particular, helps many patients, said Fu; it's possible that PT, and not the stem cell injections, should get the credit for Lacy's recovery.
How the Patients Feel
Regenexx has posted video interviews of dozens of satisfied customers on its website, including a refinery worker treated for a non-healing wrist fracture, a snowboarder who had stem cell therapy in his knees and an avid weightlifter with multiple shoulder problems. All say Regenexx helped them.
Other Regenexx patients say the treatments wasted their time and money. Several patients who posted online reviews of the company agreed to be interviewed for this article.
One is Amanda Lynch, a 42-year-old Australian trapeze artist who lives in Montreal. Lynch said she spent $7,700 last year to treat an injured ligament at a Regenexx clinic in Colorado. Doctors administered a series of injections in her knee over several days, including platelets and her bone marrow, Lynch said. She shared copies of the emails she exchanged with the clinic, a bill from Regenexx and a document in which doctors evaluated her candidacy for treatment.
But within a few months, Lynch had to undergo surgery in Montreal for both knees, she said, paying an additional $16,100, according to her medical bill. Because Lynch is Australian, she was not eligible for free care in the Canadian health system and had to pay out-of-pocket.
Roland Jersevic, a 67-year-old lawyer living in Saginaw, Mich., said he needed knee replacement after his stem cell treatments failed to relieve his arthritis. Jersevic said he went to a Regenexx clinic in Toledo, Ohio, in 2015 to get help with severe arthritis in his knees, which had caused his legs to bow. "The pain was horrendous all the time," he said. Jersevic's medical bills, obtained for this article, show that he paid the clinic $7,500 out-of-pocket because his insurance wouldn't cover stem cell therapy. "They told me they were going to regrow my cartilage," he said, referring to Regenexx. "I wanted it to work."
Although the fat and bone marrow injections may have given Jersevic a "little bit" of temporary relief, his pain soon returned, he said. Regenexx offered to administer more injections, at an additional cost, Jersevic said. "At that point, I had lost all faith in what they were doing. To spend more money on a booster—what for? It wasn't working."
Jersevic had both knees replaced in summer 2016, his medical records show, and his insurance paid most of the bill. His knee pain is gone, and Jersevic said he felt well enough to return to track-and-field competitions—including hurdles and pole vaulting—in 2017.
"When your knees are that bad, it's not going to work for you," Jersevic said. "They should tell you it's not going to work for you. But they want the cash."
In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.
"We are disappointed to learn of any patients who didn't have a positive outcome," Regenexx said in a statement. "Our goal at Regenexx is to achieve the best possible clinical efficacy, and we are actively researching to find out why some patients respond better than others."
Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), who are pushing a major legislative package to lower health costs, announced their favored solution to handle disputes about surprise medical bills.
Those unexpected and often high charges patients face when they get care from a doctor or hospital that isn't in their insurance network are a perpetual complaint from consumers.
Alexander and Murray formally introduced their wide-ranging bill Wednesday, but they had offered a broad outline before without taking a stand on how to mediate between health care providers and patients on the surprise bills.
When a patient is seen by a doctor who isn't in their network, the Alexander-Murray bill says insurance would pay them the "median in-network rate," meaning the rate would be similar to what the plan pays other doctors in the area for the same procedure. If there aren't enough other doctors covered by the plan to compute a median in-network, the plan would use a database of local charges that is "free of conflicts of interest."
Alexander said in a written statement that his decision was swayed by an assessment by the Congressional Budget Office, which "indicated that the benchmark solution is the most effective at lowering health care costs."
According to early numbers from a CBO report, benchmarking could save $25 billion over the next 10 years. Loren Adler, associate director of USC-Brookings Schaeffer Initiative for Health Policy, said that means commercial insurance premiums would be reduced by about a half-percent.
"That's pretty significant for federal policy," Adler said.
The formula is similar to what a different group of bipartisan senators, led by Sen. Bill Cassidy (R-La.), proposed earlier this year. The critical difference is that in the Cassidy bill if the insurer and doctor can't agree on a median-in-network rate, they can take their case to an independent arbitrator.
The provider community has pushed back on any attempt to set a "benchmark" for physician pay, like the one in Alexander and Murray's bill.
At a hearing Tuesday before the Health, Education, Labor and Pensions Committee — of which Alexander and Murray are the chairman and ranking member, respectively — Tom Nickels, executive vice president of the American Hospital Association, said benchmarking would hurt efforts to set up broad insurance networks because providers and insurers would already know what they would be paid for surprise bills and it would be hard to recruit physicians to adequately staff hospitals.
"Health plans and hospitals have a long-standing history of resolving out-of-network emergency service claims, and this process should not be disrupted," he said in written testimony.
Alexander also pointed out that Rep. Frank Pallone (D-N.J.), chairman of the House Energy and Commerce Committee, and Rep. Greg Walden (R-Ore.), the ranking member of that committee, have also recommended this proposal.
Although it isn't the most aggressive solution the committee could have picked, according to Adler, it's still a positive step, and he said it was promising that an influential health committee in the Senate and an influential health committee in the House are on the same page.
"There's some logic to moving trains in the same direction," Adler said.
The Alexander-Murray legislation says that any care the patient receives would count toward their in-network cost sharing, like their deductible, coinsurance or copay.
Once they are stable and lucid after an emergency, patients must be given written notice that they are going to be seen by an out-of-network doctor, an estimate of how much that could cost, and a list of in-network doctors or facilities where they could seek care.
The bill specifies that the notice must be short, easy to read and that consent to see an out-of-network doctor is clearly optional. If the patient doesn't get this document, they can only be billed at an in-network rate.
The study found no evidence that beneficiaries who lost coverage secured either jobs or other insurance coverage. In fact, it noted a dip in the employment rate among those eligible for Medicaid.
The Medicaid work requirement plan devised by Arkansas and approved by the Trump administration backfired because it caused thousands of poor adults to lose coverage without any evidence the target population gained jobs, a new study finds.
In fact, the requirement had only a limited chance for success as nearly 97% of Arkansas residents ages 30-49 who were eligible for Medicaid—those subject to the mandate—were already employed or should have been exempt from the new law, according to the study published Wednesday in the New England Journal of Medicine.
Yet the state's mandate—the first of its kind in the nation—resulted in 18,000 of the 100,000 targeted people falling off the Medicaid rolls. And despite administration officials' statements that many of them may have found jobs, the study by researchers at Harvard found no evidence they secured either jobs or other insurance coverage. In fact, it noted a dip in the employment rate among those eligible for Medicaid.
The researchers said the uninsured rate increased among 30- to 49-year-old Arkansans eligible for Medicaid from 10.5% in 2016 to 14.5% in 2018, while the employment rate fell from about 42% to just below 39%.
While the thousands of Arkansas residents losing Medicaid coverage has been documented since last year, the Harvard study is the first to provide evidence that the change left them uninsured and did not promote employment.
The results, based on a telephone survey of about 3,000 low-income adults in Arkansas, concluded that the law befuddled enrollees and that its mandatory reporting requirements led many to unnecessarily lose coverage.
"Lack of awareness and confusion about the reporting requirements were common, which may explain why thousands of individuals lost coverage," the researchers wrote.
Asked whether the findings mean the administration should pull the plug on work requirements, co-author Benjamin Sommers, a professor of health policy and economics at Harvard, replied, "It's time for them to pump the brakes at the very least."
As millions of nondisabled adults gained Medicaid coverage following the 2010 passage of the Affordable Care Act, conservatives pushed for requiring people to work or do other kinds of "community engagement" to keep their Medicaid, much as food stamps and welfare cash benefit programs do. The Trump administration embraced that ideal and has made Medicaid work requirements a central feature of its plan to restructure the federal-state entitlement program, which has more than 70 million enrollees.
Arkansas put the plan into action in spring 2018.
But in March, a federal judge struck down Arkansas' mandate and a plan to begin one in Kentucky. U.S. District Judge James Boasberg ruled the work requirement violated federal law because it failed to meet the core objective of Medicaid — getting medical coverage to the poor.
The Trump administration is appealing that ruling and, meanwhile, has approved similar plans in eight other states, including New Hampshire, which is scheduled to start cutting coverage in August for those not meeting the rules. New Hampshire's law also is being challenged in court by Medicaid advocates.
Six more states have pending applications to add work mandates.
Seema Verma, administrator of the Centers for Medicare & Medicaid Services, defends the work requirements, saying they "are not some subversive attempt to just kick people off of Medicaid. Instead, their aim is to put beneficiaries in control with the right incentives to live healthier, independent lives."
Arkansas officials disputed the thrust of the study, noting that the requirement was short-lived because the judge intervened before it was in effect even a year and researchers did not find out why people who were dismissed from Medicaid didn't reapply.
"So you cannot describe this as the robust evaluation that we want and expect of a demonstration project that truly has national significance," said Amy Webb, a spokeswoman for the state's Medicaid program. "The best way to get answers to everyone's questions about the impact of work and community engagement requirements would be to let Arkansas continue what was started and conduct a true evaluation that follows people over time."
Under the Arkansas law, targeted enrollees were notified by the state via mail and informational flyers that they were required to work 80 hours a month, participate in another qualifying activity such as job training or community service, or meet criteria for an exemption such as pregnancy, a disability or parenting a child.
If they were out of compliance for three months during a calendar year or failed to report their status to the state through online reports, they could lose coverage.
For the first several months of its new mandate, Arkansas required enrollees to use an online portal for that reporting, a problem since 20% lacked internet access and another 20% lacked fast broadband. The state online portal also was unavailable after 9 p.m. each day.
The study found one-third of individuals subject to the policy had not heard anything about it, and 44% were unsure whether the requirements applied to them.
The findings back up arguments from advocates for the poor and nonpartisan experts that many Medicaid enrollees already have jobs. They also directly contradict claims by federal and Arkansas officials that many of those who lost coverage found a job.
In a hearing before the Senate Finance Committee earlier this year, Health and Human Services Secretary Alex Azar noted that only 1,452 of the 18,000 people who lost coverage because of the work requirement rules reapplied for Medicaid. He added that likely meant most no longer needed the government assistance.
"That seems a fairly strong indication that those people got a job and insurance elsewhere and didn't need the coverage," Azar said.
Sommers said the Arkansas experiment answers many questions about how work requirements could function nationally, although he acknowledged that other states might do a better job promoting the program and making it easier for enrollees to report their status.
"There are just not that many people [enrolled in Medicaid] who aren't working but could," Sommers said.
He noted Arkansas added the work requirement feature without adding new funding for job training or child support to help people who want to work.
Federal officials who approve the waivers allowing states to use work requirements should take note of the results, he said. "It does not make sense to keep approving the same waiver without doing anything differently," Sommers said.
About 1 in 6 Americans were surprised by a medical bill after treatment in a hospital in 2017 despite having insurance, according to a study published Thursday.
On average, 16% of inpatient stays and 18% of emergency visits left a patient with at least one out-of-network charge. Most of those came from doctors offering treatment at the hospital, even when the patients chose an in-network hospital, according to researchers from the Kaiser Family Foundation. Its study was based on large employer insurance claims. (Kaiser Health News is an editorially independent program of the foundation.)
The research also found that when a patient is admitted to the hospital from the emergency room, there's a higher likelihood of an out-of-network charge. As many as 26% of admissions from the emergency room resulted in a surprise medical bill.
"Millions of emergency visits and hospital stays left people with large employer coverage at risk of a surprise bill in 2017," the authors wrote.
The researchers got their data by analyzing large-employer claims from IBM's MarketScan Research Databases, which include claims for almost 19 million individuals.
Surprise bills don't just come from the emergency room. Often, patients will pick an in-network facility and see a provider who works there but isn't employed by the hospital. These doctors, from outside staffing firms, can charge out-of-network prices.
"It's kind of a built-in problem," said Karen Pollitz, a senior fellow at the Kaiser Family Foundation and an author of the study. She said most private health insurance plans are built on networks, where patients get the highest value for choosing a doctor in the network. But patients often don't know whether they are being treated by an out-of-network doctor while in a hospital.
"By definition, there are these circumstances where they cannot choose their provider, whether it's an emergency or it's [a doctor] who gets brought in and they don't even meet them face-to-face."
The issue is ripe for a federal solution. Some states have surprise-bill protections in place, but those laws don't apply to most large-employer plans because the federal government regulates them.
"New York and California have very high rates of surprise bills even though they have some of the strongest state statutes," Pollitz said. "These data show why federal legislation would matter."
Consumers in Texas, New York, Florida, New Jersey and Kansas were the most likely to see a surprise bill, while people in Minnesota, South Dakota, Nebraska, Maine and Mississippi saw fewer, according to the study.
Legislative solutions are being discussed in the White House and Congress. The leaders of the Senate Health, Education, Labor and Pensions Committee introduced a package Wednesday that included a provision to address it. The legislation from HELP sets a benchmark for what out-of-network physicians will be paid, which would be an amount comparable to what the plan is paying other doctors for that service.
That bill is set for a committee markup next week.
Other remedies are also being offered by different groups of lawmakers.
Aletha Maybank, MD, a pediatrician, is talks to Kaiser Health News about her challenges and priorities as the American Medical Association's Equity Chief.
This article was first published on Wednesday, June 19, 2019 in Kaiser Health News.
Part of Dr. Aletha Maybank's medical training left a sour taste in her mouth.
Her superiors told her not to worry about nonmedical issues affecting her patients' quality of life, she said, because social workers would handle it. But she didn't understand how physicians could divorce medical advice from the context of patients' lives.
"How can you offer advice as recommendations that's not even relevant to how their day-to-day plays out?" Maybank asked.
Today, Maybank is continuing to question that medical school philosophy. She was recently named the first chief health equity officerfor the American Medical Association. In that job, she is responsible for implementing practices among doctors across the country to help end disparities in care. She has a full agenda, including launching the group's Center for Health Equity and helping the Chicago-based doctors association reach out to people in poor neighborhoods in the city.
A pediatrician, Maybank previously worked for the New York City government as deputy commissioner for the health department and founding director of the city's health equity center.
Carmen Heredia Rodriguez of Kaiser Health News recently spoke with Maybank about her new role and how health inequities affect Americans. This transcript has been edited for length and clarity.
Q: Can you tell me what health equity means to you, and what are some of the main drivers that are keeping health inequitable in this country?
The AMA policy around health equity is optimal health for all people.
But it's not just an outcome; there's a process to get there. How do we engage with people? How do we look at and collect our data to make sure our practices and processes are equitable? How do we hire differently to ensure diversity? All these things are processes to achieve health equity.
In order to understand what produces inequities, we have to understand what creates health. Health is created outside of the walls of the doctor's office and at the hospital. What are patients' jobs and employment like? The kind of education they have. Income. Their ability to build wealth. All of these are conditions that impact health.
Q: Is there anything along your career path that really surprised you about the state of healthcare in the U.S.?
There's the perception that all of our health is really determined by whether you have a doctor or not, or if you have insurance. What creates health is much beyond that.
So if we really want to work on health and equity, we have to partner with people who are in the education space and the economic space and the housing spaces, because that's where health inequities are produced. You could have insurance coverage. You could have a primary care doctor. But it doesn't mean that you're not going to experience health inequities.
Q: Discrimination based on racial lines is one obvious driver of health inequities. What are some of the other populations that are affected by health inequity?
I think structural racism is a system that affects us all.
It's not just the black-white issue. So, whether it's discrimination or inequities that exist among LGBT youth and transgender [or] nonconforming people, or if it's folks who are immigrants or women, a lot of that is contextualized under the umbrella of white supremacy within the country.
Q: And what are some of your priorities?
A large part of my work will be how I build the organizational capacity to better understand health equity. The reality in this country is folks aren't comfortable talking about those issues. So, we have to destigmatize talking about all of this.
Q: Are there any particular populations or relationships that you plan to focus on?
The AMA excluded black physicians until the 1960s. So one question is, How do we work to heal relationships as well as understand the impact of our past actions? AMA definitely issued an apology in the early 2000s, and my new role is also a step in the right direction. However, there is more that we can and should do.
Another priority now is, How do we work, and who do we work with, in our own backyard of Chicago? What can we do to work directly with people experiencing the greatest burden of disease? How do we ensure that we acknowledge the power, assets and expertise of communities so that we have the process and solutions driven and led by communities? To that end, we've begun working with West Side United via a relationship at Rush Medical Center. West Side United is a community-driven, collective neighborhood planning, implementation and investment effort geared toward optimizing economic well-being and improved health outcomes.
Q: Is there anything else you feel is important to understand about health equity?
Health equity and social determinants of health have become jargon. But we are talking about people's lives. We were all born equal. We are clearly not all treated equal, but we all deserve equity. I don't live outside of it, and none of us really do. I am one of those women who were three to four times more likely to die at childbirth because I'm black. So I don't live outside of this experience. I'm talking about my own life.
When Pamela DeSalvo read the clinical note from her doctor's visit, the words on the page hit her hard: "clinically morbidly obese." She knew she was overweight, but seeing those three words together shocked her. It also inspired her to start losing weight.
"I needed to see it in black and white, what I actually in my heart already knew. It forced me to get honest with myself," DeSalvo said.
"Reading that note saved my life." Studies show that, indeed, reading your doctor's notes can improve your health.
DeSalvo lives in Metuchen, N.J., and works in health information technology. In the years after reading her doctor's notes, DeSalvo kept that experience in mind as she helped Atrium Health implement a system that allows doctors to share clinical notes.
Many patients go home with a summary of their office visit. That recap often includes a list of medications or reminders to schedule a follow-up. The full doctor's note has many more details —all the stuff the physician types into the computer during and after your medical appointment. Your medical history. The complaint that brought you to the office. Sometimes, physicians write down exactly what patients say. Mixed in are billing codes and the doctor's thoughts about what might be happening with the patient.
A research project in Boston, called OpenNotes, encourages doctors to share their notes with patients. On the flip side, it invites patients to ask for access to their doctor's notes. The project is housed at Beth Israel Deaconess Medical Center.
In onestudy, when researchers surveyed patients who'd looked at their doctor's notes, the majority of patients reported they felt more in control of their care and said they were more compliant taking medication. A small share — from 1% to 8% — said the notes caused confusion, worry or offense.
Liz Salmi, a woman living with brain cancer in Sacramento, Calif., was an experienced patient advocate and bloggerwhen she first got a look at her doctor's notes on her. After Salmi's insurance changed, she requested her medical records. For $45, she received a 4,839-page PDF on a disk along with her brain scans.
And she got curious. "I was, like, what is on these disks?" Salmi said.
There was no big revelation. And she didn't uncover any mistakes.
But it was a nice way to re-hear what her doctors had told her through the years. Salmi said the records are a time capsule of sorts. As Salmi scanned the pages, she said, she discovered "meaningful nuggets" where her doctors quoted her verbatim.
"Just that level of detail made me feel like they were listening," said Salmi, who is featured in this week's episode of the podcast "An Arm and a Leg," which is co-produced by Kaiser Health News.
Eventually, Salmi went to work for OpenNotes, and today she's a senior strategist who does outreach and communications for the research group.
The Health Insurance Portability and Accountability Act, or HIPAA, which has been the law since 1996, allows patients to review and get copies of their medical records.
But researcher Dr. Harlan Krumholz said a legal right doesn't guarantee easy access.
Krumholz, a cardiologist and professor at Yale University, published a studyin 2018 that examined the records-requesting process at 83 top-ranked hospitals in the U.S.
The results varied widely. Some hospitals didn't meet state deadlines for delivering the records, others charged exorbitant fees for the documents — well above the federal government's recommendation for electronic records.
"What is clear from this is, it is hard for Americans to get access to their own medical records," Krumholz said.
OpenNotes — the research group that advocates for better access — says that today about 40 million patients are a part of a health system that shares clinical notes through their electronic health record software. But each medical system is different, and it can take time and effort to navigate an online portal to find what you're looking for.
"I've been under the assumption for years that patients could access the notes whenever they wanted to, so I keep them objective and matter-of-fact," said Dr. Neda Frayha, an internist who practices at Ascension Medical Group in Baltimore.
She encourages her patients to review her notes.
"Being a patient is hard. Appointments take forever, and often clinicians don't spend a lot of time with patients," said Frayha. "For many patients, it is hard to make sense of what is happening. If access to their note provides them with knowledge and assurance, then that is important to provide."
Frayha said having her notes on display hasn't changed her behavior or note-taking much. But, she said, "I think it's actually good for us as a profession to be more mindful of the words we use."
Texas Gov. Greg Abbott signed legislation shielding patients from getting a huge bill when their insurance company and medical provider can't agree on payment.
This article was first published on Tuesday, June 18, 2019 in Kaiser Health News.
Texas is now among more than a dozen states that have cracked down on the practice of surprise medical billing.
Texas Gov. Greg Abbott, a Republican, signed legislation Friday shielding patients from getting a huge bill when their insurance company and medical provider can't agree on payment.
The bipartisan legislation removes patients from the middle of price disputes between a health insurance company and a hospital or other medical provider.
"We wanted to try to take the patients — get them out of the middle of it, because really it's not their fight," said Republican state Sen. Kelly Hancock, the bill's author.
Under the new law, insurance companies and medical providers can enter into arbitration to negotiate a payment — and state officials would oversee that process.
Surprise medical billing typically happens when someone with health insurance goes to a hospital during an emergency and that hospital is out-of-network. It also occurs if a patient goes to an in-network hospital and their doctors or medical providers are not in-network. Sometimes insurance companies and medical providers won't agree on what's a fair price for that care and patients end up with a hefty medical bill.
Consumer advocates in the state have urged lawmakers to do more to help Texans saddled with surprise medical bills.
Drew Calver is among the many Texans who have dealt with a surprise bill in the past few years. Calver, a high school history teacher in Austin, had a heart attack in 2017. He was rushed to the closest hospital by a friend that day, and doctors implanted stents to save his life.
Even though he had health insurance that paid the hospital more than $55,000 for his care, Calver ended up with a $109,000 bill. Calver and his wife, Erin, fought with the hospital and the insurance company for months with little success.
The Calvers eventually turned to the press. Last summer, he told his story to the "Bill of the Month" investigation from NPR and Kaiser Health News. "CBS This Morning" also covered the story. Shortly afterward, his bill was slashed to just $332. Erin Calver said she has seen her family's story strike a chord.
"For whatever reason, people could relate to us — and be scared that maybe it could happen to them," she said.
Drew Calver said he encounters many people who worry about the issue.
"The doctor that put my stents in — he either just had a baby or is about to have a baby — and he was saying that, 'Yeah that could happen to me, too!'" Calver said.
In fact, getting a steep hospital bill is something many Americans call their biggest financial fear.
"Polling shows us that the top household pocketbook concern for consumers is a surprise medical bill," said Stacey Pogue with the Center for Public Policy Priorities, a think tank that analyzes health and economic issues in Texas. "And that's actually pretty shocking that consumers will say they are more worried about their ability to afford a surprise medical bill than their health insurance premiums [and] their really high deductibles."
Last year, a Kaiser Family Foundation poll found that 67% of people worry about unexpected medical bills — a larger share than those who say they worry about prescription drug costs or basic necessities such as rent, food and gas. (KHN is an editorially independent program of the foundation.)
Pogue said that's a big reason why lawmakers in the state took the issue seriously and passed legislation that she said is now one of the strongest state protections she has seen.
"It is as strong or stronger than any of the protections in the country," Pogue said.
In addition to Texas, neighboring states Colorado and New Mexico also passed legislation in 2019 to address the problem of surprise out-of-network bills. The Commonwealth Fund's most recent report on the issue found about half of states offer some legal protections from surprise bills, but only six states had laws that provide "comprehensive" consumer protections similar to those just passed in Texas.
Texas' new surprise bill law officially takes effect Sept. 1, 2020.
Hancock said the fight over who pays disputed bills will be back where it belongs: with insurance companies, leaving the hospitals, doctors and labs to focus on providing medical care.
"It was just time to get the patient out" of the middle of disputed bills, Hancock said.
Instead, when a hospital and insurer can't agree on a price, the two parties will have to work it out — without ever billing the patient.
"There is still the ability to negotiate," Hancock said. "You didn't have government determining what the price was or determining what the settlement was."
But not all Texans will be protected by the new law. The Texas law does not apply to people who work for large employers whose plans are regulated by the federal government. In Texas, federally regulated plans account for roughly 40% of the state's health insurance market.
In fact, Drew Calver would have been exempt from the state's protections because until recently he had a self-funded health plan regulated by the federal government. However, Drew is now part of wife Erin's health plan, which will be subject to these new protections.
Pogue said people who have federally regulated health plans will be protected only if Congress acts. She predicted the state's action will spur federal lawmakers.
"Texas passing a bill will really help on that front," she said. "There were five states, I think, in 2019 that passed bills that fully protected consumers — and every nudge like that is going to help Congress move."
Texas lawmakers passed separate legislation that could help Texans with federally regulated plans. Senate Bill 1037 prevents a surprise medical bill from affecting someone's credit, regardless of what health insurance plan they have.
Congressional leaders have said they are working on coming up with a fix for people across the country with federally regulated plans. President Donald Trump also recently held an event at the White House, with Drew and Erin Calver standing by his side, announcing his administration's support for banning surprise medical billing in the country.
The committee's chairman, Austin Democrat Lloyd Doggett, said that "federal action is essential" to addressing the issue for many Americans with federally regulated plans. He said he plans to continue to push for legislation that will "finally offer some relief to patients." However, no legislation has been passed, yet.
During his opening statements, Doggett said there is a bipartisan desire to shield patients from surprise bills, but "conflict remains over how to resolve insurer-provider disputes."
This story is part of a partnership that includes KUT, NPR and Kaiser Health News.
Experts caution that as ECMO becomes more available, it is also being used as a last-ditch attempt to buy more time for dying patients with poor chances of survival.
This article was first published on Tuesday, June 18, 2019 inKaiser Health News.
The latest miracle machine in modern medicine — whose use has skyrocketed in recent years — is saving people from the brink of death: adults whose lungs have been ravaged by the flu; a trucker who was trappedunderwater in a crash; a man whose heart had stopped working for an astonishing seven hours.
But for each adult saved by this machine — dubbed ECMO, for extracorporeal membrane oxygenation — another adult hooked up to the equipment dies in the hospital. For those patients, the intervention is a very expensive, labor-intensive and unsuccessful effort to cheat death.
ECMO, the most aggressive form of life support available, pumps blood out of the body, oxygenates it and returns it to the body, keeping a person alive for days, weeks or months, even when their heart or lungs don't work.
The invention is creating "an entirely new paradigm," said Dr. Kenneth Prager, director of clinical ethics at Columbia University Irving Medical Center. "You have a heart that's not working, yet the patient is not dead."
Most commonly used for newborns, ECMO use has been growing dramatically among adults. In the United States, procedures tripled from 2008 to 2014, up to an estimated 6,890, according to the federal Agency for Healthcare Research and Quality.
Experts caution that as ECMO becomes more available, it is also being used as a last-ditch attempt to buy more time for dying patients with poor chances of survival.
ECMO is not designed to be a destination, but a bridge to somewhere — recovery, transplantation or an implanted heart device. But when patients are too sick to reach those goals, ECMO can become a "bridge to nowhere," leaving the patient in limbo, possibly even awake and alert, but with no chance of survival outside the intensive care unit. Medical teams and families can be fiercely divided over when to pull the plug.
ECMO is very expensive, mostly due to the labor involved: A person on ECMO cannot live outside the ICU and must be continuously monitored for complications, such as blood clots, bleeding, infection and loss of blood to the limbs. Median charges for ECMO in 2014 were $550,000, making it the 15th-most-costly procedure that year, according to the AHRQ.
In one recent case, a teaching hospital charged $4.2 million for a 60-day ECMO stay for a 19-year-old man with acute respiratory distress syndrome who was comatose the entire time and did not survive, according to Dr. Merrit Quarum, CEO and founder of WellRithms, a cost-containment company. Quarum said a self-insured health plan is covering the bill.
The number of U.S. hospitals offering ECMO has more than doubled from 108 in 2008 to 264 today, according to a registry run by the Extracorporeal Life Support Organization (ELSO), which tracks most but not all programs.
"In the United States, the competition between hospitals is so intense that every hospital wants the ability to provide this level of care," said Randy Bartilson, president of the ECMO Advantage consulting firm.
But "as ECMO expands, there's still a lot of places that still don't fully understand what it can do and how to use it," he said.
Four patient stories highlight the promise — and complexities — of this game-changing technology.
The Seven-Hour Code
Dr. Jessica Zitter was working in the ICU in an Oakland, Calif., hospital one day when she got summoned for a code blue. A 60-year-old patient had arrived with a heart attack. His heart went into ventricular fibrillation, where it just wiggled like "a bag of worms," she said.
Hospital staff started pumping their palms on the man's chest and put a tube in his throat to help him breathe. Every so often, they stood back and zapped his heart with an electric shock. It didn't work. So, they strapped onto his chest a LUCAS machine, which automatically performs chest compressions like a jackhammer.
The man's oxygen levels were plummeting. At the same time, Zitter recalled, he kept moving, giving her the feeling there was a life to be saved. The medical team decided to go to the next level: ECMO. Everyone waited, with the jackhammering compressions still going, as an ECMO team scrambled to get there from another hospital across the city.
Zitter watched in awe as the ECMO team from the University of California-San Francisco got to work. They stuck one huge tube in a femoral artery and one in a femoral vein. As they pumped his blood out, it was black from deoxygenation. But after it ran through the ECMO machine, she recalled, it transformed into a bright red.
Once on ECMO, the patient didn't need his heart, so it could sit idle and recover. Zitter watched as oxygen returned to his body and brain. He was whisked back to UCSF.
Zitter, who has written about the overuse of modern technology to prolong death, wasn't optimistic. The patient had coded, with people and machines ramming his failing heart, for an astonishing seven hours before ECMO arrived. But as she kept tabs on the patient, she was amazed to learn that he was able to recover and go home.
The case was a "big shocker," Zitter said.
But it was "a crazy, crazy, crazy outlier case with a crazy, crazy, crazy outlier response," she cautioned. "When these kinds of things happen, people tend to look at them and assume that they will have the same odds. The reality is that they won't."
When patients receive ECPR (ECMO for cardiopulmonary resuscitation), only 29% make it out of the hospital alive, according to international statistics from ELSO. Survival rates are higher for people who use ECMO for only the lungs (59%) or only the heart (42%), according to ELSO.
Saving 'Santa'
A more common outcome for ECPR looks something like what Dr. Haider Warraich of Duke University Medical Center came across three or four years ago during his cardiology training.
Warraich was called to the waiting area of a lung transplant clinic, where a man in his 60s had collapsed on the floor due to a heart attack. The man, who had white hair and a scraggly beard, played Santa every Christmas, Warraich later learned. "Santa" — as Warraich refers to him in his upcoming book, "State of the Heart" — had received a new set of lungs after his were wrecked by smoking and lung disease.
The man's heart, starved of oxygen, sped up into a malignant rhythm. CPR and electric shocks didn't bring it back. Motivated to save not only the patient but the new set of lungs he had received, the team called in ECMO.
The ECMO squad arrived with catheters "the size of small javelins," Warraich recalled. Once Santa was hooked up on ECMO, the exhausted CPR team could stop. Cardiologists did surgery on a blocked artery, but they never got his heart back to normal. The man lingered for a month, using ECMO for his heart, a ventilator for his lungs and dialysis for his kidneys, before he died.
In this case, using ECMO felt appropriate, Warraich said. But he said doctors need more guidance to determine which patients would benefit the most and to prevent overuse.
"If you have someone who is dying in front of you, it's really hard to step back and think about it," he said.
The technology, developed in the 1970s, was initially used primarily for newborns. Early clinical trials in adults were discouraging. But in 2009, the CESAR trial in the United Kingdom showed positive results for ECMO in adults with severe respiratory failure. Those findings, combined with improved technology and an epidemic of swine flu, prompted a swift growth of ECMO among adults. The average age for U.S. adults receiving ECMO is 51, one study found. About 1 in 10 ECMO cases are for people over 65.
Warraich and other experts say they are now concerned that new organ-donation rules may inadvertently spur hospitals to place more patients on ECMO: Under guidelinesapproved by the Organ Procurement and Transplantation Network last October, patients on ECMO jump to the front of the heart transplant waiting list.
An 'Unbearable' Choice
Once a patient is on ECMO, deciding when to stop can cause moral distress and division among medical staff, said Dr. Robert Truog, director of the Center for Bioethics at Harvard Medical School.
In one case Truog described in The Lancet, a 17-year-old boy came to the ICU at Boston Children's Hospital, where Truog works as a physician. The boy, who had already had one lung transplantation for cystic fibrosis, was now in end-stage respiratory failure. The only way to save his life was to give him another set of lungs. He started on ECMO as a bridge therapy while he awaited transplantation.
The boy was fully conscious, doing homework, texting friends and visiting with family. But after two months of living in the ICU, he was diagnosed with untreatable cancer that made him ineligible to receive new lungs.
Clinicians were deeply divided over what to do next, Truog said. Some wanted to stop ECMO immediately because its original goal — a bridge to transplantation — was no longer possible.
Others argued that even though he couldn't survive outside the ICU, the boy seemed to have a good quality of life on ECMO, and his family and friends "derived benefits from his continued survival," Truog wrote. They argued that the family should have the right to continue this form of life support, just as with dialysis, ventilation or an artificial heart.
A third argument arose, Truog said: If leaving this patient on ECMO was appropriate, then in fairness "why don't we put everyone with respiratory failure on ECMO?"
For the parents, Truog said, it was "unbearable" to choose a day or moment to turn off ECMO, because they knew their child would immediately die.
Clinicians devised an alternative the family would agree to: They decided not to replace the ECMO oxygenator, a part that needs to be changed every week or two when it develops blood clots. After about a week, the oxygenator gradually failed and the patient lost consciousness and died, Truog said.
The solution "allowed him to die in a way where we didn't feel like we were choosing the moment of his death," he said.
The solution was not optimal, Truog said. But "no matter how you do this, it's going to be very emotionally upsetting to everyone. These are the cases that make some people leave the profession because they're so hard."
A Long Goodbye
Karen Ayoub had never heard of ECMO until her husband became direly ill.
Philip Ayoub, 58, an accountant and former comptroller for the National Football League, was a "huge personality" and a family man; the couple raised twin boys in Greenwich, Conn. Heart disease, which ran in his family, hit him early: He had his first coronary bypass surgery at age 30 and his second at 43, she said.
"He knew that his life might be foreshortened" and "tried to pack as much living into it as possible," said Karen Ayoub, 55. Her husband told her he didn't want any extraordinary lifesaving measures — he was happy with the life he had lived, she said.
In December 2017, he had a third bypass surgery at a hospital on Long Island, and it didn't go well. His heart was weaker than anticipated. He became unconscious, and it wasn't clear if he would ever wake up. He was transferred to Columbia University Irving Medical Center, which has an ECMO program.
Karen Ayoub said it was a fairly easy decision to put her husband on ECMO: "I thought he deserved any chance possible to recover," she said. But she didn't know how he'd react.
"I wasn't sure if he was going to wake up and say, 'Why did you do this? I didn't want any of this!'" she recalled.
When her husband regained consciousness, he mouthed the words: "Why am I here?"
He remained in the ICU for two months, on a feeding tube, breathing tube, ECMO and dialysis. His time there was not easy, she said: Her husband, who had endured a series of mini-strokes during the bypass surgery, began to experience post-traumatic stress disorder, night terrors and side effects from medications.
The only option for further treatment, she said, was to get an implanted device that would help his heart pump. But as he weighed that decision, and the quality of life he would have, the window of time closed when he was eligible for the device, Karen Ayoub said.
When further treatment became out of reach, it was clear her husband was going to die.
"His body was failing him," Karen Ayoub said. "It was time."
She said the two months in the ICU felt like "a gift," because she and her children got to spend extra time with her husband.
"I'll always love you, I'll always be with you," he told his wife over and over during that time.
She said she would make the same choice again to initiate ECMO, but "I don't know about him — he was the one laying in that bed for two months, being tortured by needles and night visions."
After they ran out of treatment options, the family gave permission for the hospital to discontinue life support. Philip wasn't afraid, she said: As his final day approached, he told her, "I can't wait to see what comes next."
Philip was sedated before ECMO was turned off. Karen Ayoub laid her head on her husband's chest and held his hands as he died.
"It was peaceful and respectful," she said, "exactly what he wanted."
'Futile' Care
While the Ayoub family bravely accepted their fate, other families can't bring themselves to let go, said Dr. Shunichi Nakagawa, a palliative care doctor at Columbia who cared for Philip Ayoub.
Some ECMO patients have severe, irreversible brain damage, can't participate in decision-making and bear no chance of making it out of the hospital alive. For them, ECMO represents "the most extreme form of medical futility," Nakagawa argued in an article he and Prager co-authoredwith a colleague in the journal Circulation. They argue that clinicians should have the authority to end or limit life support in such hopeless cases, even if the family objects.
Whether they can do that depends on where they practice: Laws in states such as Idaho, Oklahoma and New York make it difficult to withdraw life-sustaining treatment like ECMO without consent from patients or their families, said Thaddeus Mason Pope, director of the Health Law Institute at Mitchell Hamline School of Law in St. Paul, Minn. But in states like California, Texas and Virginia, clinicians may withdraw ECMO without consent, he said.
Dr. Robert Bartlett, a pioneer of the ECMO field and professor emeritus at the University of Michigan, said he trains doctors that once ECMO becomes a bridge to nowhere, they should tell the family, "We talked about futility, and now we're there. So we're going to turn the circuit off tomorrow."
"It's extremely discourteous to the family to ask the family what to do," he said.
At Cedars-Sinai Medical Center in Los Angeles — where patients with poor chances of survival were being put on ECMO, and families were getting conflicting messages about the potential benefit — staff launched an improvement effort that has created more consensus and consistency around appropriate ECMO care, according to Dr. Michael Nurok, medical director of the cardiac surgery ICU.
At the University of Southern California's Keck Hospital, every family of an ECMO patient meets weekly with palliative care and other clinicians to talk about goals of care — conversations that have been "transformative" for families, said Dr. Sunita Puri, medical director of palliative medicine and supportive care.
In Boston, Dr. Daniela Lamas, a critical care doctor at Brigham and Women's Hospital, said she has seen ECMO's promise and its limitations.
"With every escalation and fancy machine comes a lot of hope," Lamas said. "It's really hard to temper that hope with the realities that with each new thing comes a host of ethical questions and dilemmas."
ECMO, she said, is "a fantastic example of 'just because you can, doesn't mean you should.'"