Volume has long been considered one of the key metrics for predicting surgical success.
The "vast majority" of hospitals do not meet minimal hospital or surgeon volumes for eight high-risk procedures, or policies in place to monitor the appropriateness of surgeries, with rural hospitals lagging far behind uban hospitals, a new analysis from The Leapfrog Groupshows.
Less than 3% of the 2,000 hospitals who took part in the voluntary survey met the volume thresholds for two of the high-risk procedures: open abdominal aortic aneurysm repair, and esophageal resection for cancer. Adequate volumes for bariatric surgery were achieved by 38% of the hospitals, Leapfrog found.
"It's clear from this report that patients should be very careful before they choose a hospital for one of these high-risk procedures," Leapfrog CEO and President Leah Binder said in prepared remarks.
"Beyond the disturbing findings in this report, patients should worry even more about hospitals that decline to report this information at all, because candor and transparency is the necessary first step to improvement," she said.
This year's report is the first time that Leapfrog has included a volume metric for surgical procedures and whether hospitals monitored for surgical necessity.
Volume has long been considered one of the key metrics for predicting surgical success, although some studies suggest that surgical specialty is a better gauge of successful outcomes.
Erica Mobley, Leapfrog's director of operations, said "higher patient volumes does not necessarily mean higher quality, but lower volume is not adequate for patient safety."
"Hospitals and surgeons that do a very low number of a given procedure per year cannot hone the techniques and skills necessary to successfully perform these complex and high-risk procedures," she said.
In 2015, a U.S. News & World Report study estimated that as many as 11,000 deaths could have been prevented if patients who went to the lowest-volume hospitals went instead to the highest-volume hospitals.
"The reality is that in healthcare, particularly when it comes to highly specialized care, like transplants, NICU procedures or open-heart surgery, procedure volume is critical in order to have positive patient outcomes," John D. Couris, president and CEO of Tampa General Hospital, said in a recent HealthLeaders opinion piece.
"Research continues to demonstrate that the more times a hospital performs a surgery or other procedures, the better the outcomes, the better the patient care and the lower the cost," Couris said. "High-volume thresholds ensure proficiency in skill by the physicians, which, in return, reduces the amount of medical errors."
"Without CON in place, we are now more likely to experience an increase in hospitals where providers perform complex procedures less often, maybe only a handful of times," he said.
Mobley said the Leapfrog analysis didn’t specifically evaluate certificate of need laws or compare results to areas in which CON laws are in place.
"That said, any efforts that can help to ensure that hospitals and surgeons perform an adequate volume of surgeries per year will ultimately improve surgical safety for patients," she said. "Health systems in particular can help remediate this problem by consolidating surgical services for a high-risk procedure into a single facility rather than having multiple hospitals perform the same surgery only a handful of times each year."
Not surprisingly, the report also shows that urban hospitals consistently outperform rural hospitals across all eight high-risk procedures. No rural hospital met Leapfrog's volume standard for five of the eight procedures.
Mobley said the problem is that "hospitals and surgeons are performing surgeries when they shouldn’t be."
"Hospitals and surgeons without adequate, ongoing experience with a particular procedure should refer the patient to a different facility and physician that perform more of this surgery rather than doing it themselves at that location," she said. "This isn’t always an easy conversation, but it is critical in order to provide patients with the safest care."
In prior guidance, the Internal Revenue Service and the Treasury have not included preventative care for services or benefits meant to treat an existing condition.
The U.S. Treasury has expanded preventive care benefits provided by high deductible health plans for some chronic conditions.
Under a notice issued Wednesday, HDHP enrollees can deduct contributions to a health savings account for medical care and prescription drugs for conditions such as diabetes, asthma, depression, and heart failure.
In prior guidance, the Internal Revenue Service and the Treasury have not included preventative care for services or benefits meant to treat an existing condition.
"However, the Treasury Department and the IRS are aware that the cost barriers for care have resulted in some individuals who are diagnosed with certain chronic conditions failing to seek or utilize effective and necessary care that would prevent exacerbation of the chronic condition," Treasury said in the notice.
"Failure to address these chronic conditions has been demonstrated to lead to consequences, such as amputation, blindness, heart attacks, and strokes that require considerably more extensive medical intervention," the notice said.
Treasury Secretary Steve Mnuchin said the Trump administration's expansion of preventive care benefits and access to health savings accounts "will enable more Americans to exercise greater control over their medical care."
"Cost barriers should not prevent those suffering from chronic conditions from getting the medical care they need. This more inclusive coverage will empower Americans to make the best healthcare decisions for themselves and their families," Mnuchin said in prepared remarks.
The notice does not affect the status of any medical care previously recognized as preventive care.
Mark Fendrick, MD, director of the University of Michigan's Center for Value-based Insurance Design, said the coverage expansion comes "as more and more Americans are facing high deductibles…. (and) struggling to pay for their essential medical care."
"Our research has shown that this policy has the potential to lower out-of-pocket costs, reduce federal health care spending, and ultimately improve the health of millions diagnosed with chronic medical conditions," Fendrick said.
Matt Eyles, president and CEO of America’s Health Insurance Plans, said that, for the 22 million Americans enrolled in HSAs, the new guidance "improves access to affordable medications, treatment and medical equipment – all before patients must meet their deductible."
"With this new policy, insurance providers will be able to offer enhanced preventive care before facing any deductible costs to help patients better manage their chronic conditions and avoid serious complications," Eyles said in prepared remarks.
Kim Buckey, vice president of client services at health insurance consultants DirectPath, called the expanded preventive benefits "good news for employers and employees."
"Many employers have been covering these types of medications as 'preventive' for these types of patients for a while now, so it’s encouraging to see the IRS recognizing what’s becoming standard practice, Buckey said.
"Hopefully, covering these medications pre-deductible for HDHP participants will encourage patients to fill those prescriptions, stick to the regimen prescribed by their doctors and delay/prevent the onset of more serious and acute conditions—which, in turn, will save both the employer and the employee money," she said.
Research shows 'Rory's Regulations' are saving lives, but one physician urges other states to 'proceed with caution.'
New York's statewide sepsis protocols appear to be working, according to a new study out this week in JAMA.
The protocols–known as Rory's Regulations–became law in 2013, following the death of 12-year-old Rory Staunton from undiagnosed, untreated sepsis. The protocols mandate that all hospitals adopt evidence-based practices for the identification and treatment of sepsis.
University of Pittsburgh researchers examined more than a million sepsis admission records from New York and four control states–Florida, Maryland, Massachusetts, and New Jersey– in the years before and after Rory’s Regulations took effect. They found that sepsis mortality rates dropped 4.3% in New York and 2.9% in the control states, according to the JAMA report.
The Pitt researchers showed that New York's sepsis death rate was 3.2% lower following the regulations than would have been expected, relative to the control states.
Lead author Jeremy Kahn, MD, says the study is the first to conclusively link improvements in sepsis outcomes with the implementation of holistic, evidence-based regulations.
Kahn spoke with HealthLeaders about the study findings, what they're doing right in New York state, and how that model might –or might not– work for other states.
HLM:What specifically is it that they're doing in New York that is driving success?
Kahn: Three things. One is all hospitals are mandated to implement protocols for evidence-based treatment and recognition, and more patients are getting these evidence-based therapies, specifically, early antibiotics and early resuscitation. That's really the core element of the protocols.
They're also educating staff at all hospitals in New York state so that people are going to recognize and treat sepsis better.
The third thing is they're just paying attention to it. Sepsis has been not on the public health radar for many years that focuses on heart attacks and strokes and other things that are easier to recognize, and perhaps easier to treat. Just by turning our lens to sepsis, we're able to think about it in new ways, recognize it earlier and treat it more effectively.
HLM: Does the New York model shed any light on how people acquire sepsis in the first place?
Kahn: That's still is a big unknown, and the regulations don't address that. We don't yet understand why two people get the same infection, but one gets horrible sepsis and one seems to do fine. That's a much stickier wicket and another pressing public health issue.
HLM: How many states have these sepsis initiatives?
Kahn: Two other states have pulled the trigger. One is Illinois and the others New Jersey. There are 10 to 12 states that are actively considering these regulations, including my own state, Pennsylvania. This study will prompt the rest of the states to take a harder look at whether this regulatory approach to sepsis care is useful, because we show that at least in New York, it appears to have been.
HLM: As you note, sepsis is getting more attention, but the sepsis caseload also appears to be growing. What's going on?
Kahn: Part of the answer is we're looking for it more. Whenever you look for something, you're more likely to find it. Another part is that healthcare is just shifting over the last few decades. We're doing more high-risk surgeries, doing more chemotherapy, creating more immunosuppressed patients, and those things all increase the risk of sepsis.
HLM: Are you recommending that other states take up the New York model?
Kahn: My belief is that we proceed with caution. We now have very rigorous evidence that these policies can work, but we don't yet know whether they will work in other states, and we don't yet know what makes them work so well in New York. It's reasonable for other states to proceed, but with abundant caution, because there are downsides to these policy-based approaches to sepsis care.
HLM: What are those downsides?
Kahn: There are two downsides. One is the straightforward risk of overtreatment. There's the concern that when you're forcing hospitals through regulatory mandate to do the right thing, that we will treat people too aggressively.
We found evidence of that in New York because more patients got invasive central venous catheters and those have risks. More patients were admitted to the ICU and admission to the ICU has risks.
Those things also carry costs. Are we giving too many people antibiotics? Are we giving too many people fluids? The antibiotic issue is such a sticky wicket because there's antibiotic resistance concerns.
The other downside is a bit more conceptual, which is that this is quite a heavy hand. We're mandating that hospitals adopted these evidence-based practices. In the United States, we've not been so aggressive with our health policies in the past. We use more gentle nudges to get providers to do the right thing; things like financial incentives in the form of pay for performance and value-based purchasing.
We use public reporting, which is a market-driven approach, to get providers to better adopt evidence-based practices. This is a much blunter approach. And it raises concerns because the evidence might change. These regulations need to be flexible enough to accommodate those changes.
It does give pause for us to ask if this is how we want to get providers to do the right thing? My personal belief is that physicians and hospitals have had decades to do the right thing on their own, and if there's any consistent observation in healthcare in the last 20 years, it's the gap between evidence and practice. Given that sepsis is a public health crisis, it's not unreasonable to at least try these somewhat heavy-handed policies if we go in with an open eye and make sure they're not causing more harm than good.
HLM: What are some of the roadblocks to more widespread adaptation of aggressive sepsis measures?
Kahn: We need more resources. This is an unfunded mandate. We're not asking hospitals. We're telling hospitals to engage in quality improvement, and that's very expensive. That is particularly concerning for small hospitals, rural hospitals, safety-net hospitals. My concern then is by incentivizing this very extensive quality improvement, we might be widening health disparities. There's some evidence of that in New York.
One way to change these regulations is to include provisions that create a regional quality improvement collaborative that facilitates hospitals working together so we make sure that this rising tide lifts all boats, as opposed to most of the quality improvement happening in only selected hospitals.
HLM: How much did the New York model cost to implement? Is there a breakdown on the per-patient cost?
Kahn: No, we don't have data on that. We don't know either for the patient level, or the overall cost. We did find evidence that that the regulations lead to more intensive treatment, and obviously there's a cost to implementing those.
The real cost for hospitals is the effort in developing and maintaining these protocols. A lot of hospitals use IT to support responding to the regulations if they build in a sepsis alert into their electronic health records. Those things are very costly.
We also found a lot of hospitals are hiring dedicated sepsis coordinators to oversee sepsis quality improvement and that's a very, very expensive thing. When a hospital can afford it, it's likely to have an impact. But those costs are typically absorbed by the hospital, and that lowers overall margins. It's not to the point where it's threatening the financial health of any hospital, but it is important to consider that this is, at its core, an unfunded mandate.
HLM: Where should other states start if they want to emulate the New York model?
Kahn: The first thing is to get the right people at the table. One of the things that was most successful about the New York experience was that it wasn't just the regulators developing and implementing this policy. The health systems, the clinicians and the patients' advocates were all at the table in an exceptionally collaborative effort to develop and implement these policies.
The CBO estimates that most of the savings would come from reduced federal subsidies for healthcare and health insurance.
A U.S. Senate bill aimed at protecting patients from surprise medical bills could also save the federal government about $7.5 billion over the next decade, according to estimates released Tuesday by the Congressional Budget Office.
CBO estimates that under the sweeping Lower Healthcare Cost Act of 2019 the federal government would have to spend about $18.6 billion through 2029, primarily for additional funding for community health centers and other federal programs.
However, that outlay would be more than offset by about $26.2 billion in savings generated by reduced federal subsidies for healthcare and health insurance, CBO says.The bill cleared the Senate Health, Education, Labor and Pensions Committee in late June on a bipartisan vote, and bill sponsor Sen. Lamar Alexander, R-Tennessee, hopes to have it passed on the Senate floor and signed by President Donald Trump by the end of July.
Last week, the House Health Subcommittee passed its own bipartisan package of healthcare reform measures, including a bill dealing with surprise medical bills.
In addition to addressing surprise medical bills, some of the Lower Healthcare Cost Act's 55 proposalswould also: allow cheaper generic or biosimilar drugs to enter the market earlier; impose new rules on contracts between insurers, providers, and pharmacy benefits managers; extend funding for community health centers and other federal healthcare programs; improve consumer access to healthcare cost and quality information; and prohibit some medical billing practices.
The CBO provided some caveats with their estimates, noting that it would be difficult to gauge the effect of provider and payer responses to the bill's provisions, or how well federal and state agencies would be able to implement the law.
The levy caps the amount of untaxed health benefits employers can provide to their workers with the goal of slowing healthcare spending.
One-in-five employer-sponsored high-cost health plans could be slapped with the Affordable Care Act's "Cadillac Tax" when it takes effect in 2022, according to a new analysis.
The Kaiser Family Foundation study found an even larger share – 31% of health plans – could be affected when workers’ contributions to flexible spending accounts are accounted for.
The Cadillac Tax was supposed to take effect in 2018, but Congress delayed the measure until 2022. Lawmakers are considering a bill that would repeal the tax, which caps the amount of untaxed health benefits employers can provide to their workers with the goal of slowing healthcare spending.
About 156 million people get their health insurance coverage through an employer, making it the largest source of coverage in the United States.
The tax slaps a 40% levy of workers' health benefits above a threshold, adjusted annually for inflation. In 2022, the thresholds are estimated to reach $11,200 for single coverage and $30,100 for family coverage, KFF said.
The KFF analysis uses its own 2018 Employer Health Benefits Survey to estimate the share of employers with at least one health plan that would exceed the cap, with and without FSA contributions, because workers could simply stop using those account to avoid the tax, KFF said.
The tax would affect more employers over time, reaching 37% in 2030 without including FSA contributions, and 46% with them, KFF said.
KFF said it did not attempt to estimate how many employers or employees would pay the tax, only the current plans that would be surpass the thresholds if nothing else changed.
"It is likely many such employers would modify their plans to avoid the tax – for example, offering lower-cost plans, raising deductibles or otherwise shifting costs to workers to avoid the threshold," KFF said.
The England-based company denies any wrongdoing and said the settlement 'is in the best interests of the company and its shareholders.'
Reckitt Benckiser Group plc will pay $1.4 billion to settle criminal and civil investigations into the marketing of the drug maker's opioid addiction treatment drug Suboxone, theDepartment of Justice announced Thursday.
The settlement – so far, the largest involving an opioid drug – includes criminal forfeitures totaling $647 million, civil settlements with the federal and state governments totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million, DOJ said.
"It avoids the costs, uncertainty and distraction associated with continued investigations, litigation and the potential for an indictment at a time of significant transformation under RB 2.0 and during CEO transition," the company said.
Suboxone and its active ingredient, buprenorphine, are opioids. The drug is used by recovering opioid addicts to reduce withdrawal symptoms.
According to a federal criminal indictment, Indivior Inc., a one-time subsidiary of RB Group (then known as Reckitt Benckiser Pharmaceuticals Inc.) between 2010 and 2014 allegedly took part in an illegal scheme to increase prescriptions of Suboxone across the United States.
Indivior allegedly promoted the film version of Suboxone to healthcare providers and administrators and Medicaid officials as less-divertible and less-abusable than other buprenorphine drugs, even though they had no evidence to back up the claims.
The indictment further alleges that Indivior used its supposed help line for opioid-addicted patients as a conduit to connect them with doctors who would prescribe Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a "careless and clinically unwarranted manner," DOJ said.
In addition, Indivior announced a "discontinuance" of its tablet form of Suboxone based on supposed "concerns regarding pediatric exposure" to tablets. The real reason why the drug maker discontinued the drug, prosecutors allege, was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.
Prosecutors said the schemes converted thousands of opioid addicts to Suboxone, which caused state Medicaid programs to expand coverage for the drug at a substantial cost.
To resolve criminal liability, RB Group signed a non-prosecution agreement under which it will forfeit $647 million it earned from Indivior sales and stop the production, marketing and sale of Schedule I, II, or III controlled substances in the United States for three years.
"This is a landmark moment in our fight to hold drug companies responsible for their role in the opioid crisis," Virginia Attorney General Mark Herring said in prepared remarks. "We will not allow anyone to put profits over people, or to exacerbate or exploit the opioid crisis for their own benefit."
Under the civil settlement, RB Group will pay $700 million to resolve claims that it's alleged illicit marketing of Suboxone from 2010 through 2014 caused false claims to be submitted to state Medicaid programs.
The $700 million settlement amount includes $500 million to the federal government and up to $200 million to states.
Under a separate agreement with the FTC, RB Group will pay $50 million to resolve claims that it unfairly impeded competition from generic equivalents of Suboxone.
"Buprenorphine products are approved for use in the treatment of Americans struggling to overcome opioid addiction," said Gail Levine, a deputy director of the FTC's Bureau of Competition. "In the middle of the nation’s opioid crisis, RB Group allegedly sought to deny those consumers a lower-cost generic alternative to maintain its lucrative monopoly on the branded drug," she said.
Erika Kelton, a litigator with Phillips & Cohen LLP, who supplied the federal government with whistleblower information about Insys' illegal marketing of its synthetic opioid Subsys, said the RB Group settlement "demonstrate, once again, how misleading statements by pharmaceutical manufacturers can have devastating effects on patients."
"Pharma companies show astonishing disregard for vulnerable patients when they market their opioid products as safer and less susceptible to abuse than other opioid products, when the reality is that they are just as addicting and dangerous," said Kelton, adding that the penalties against RB Group are not severe enough.
"Financial settlements alone do not have a sufficient deterrent effect to really stop this kind of misconduct in the pharmaceutical industry," she said. "As a general matter, people need to be held personally accountable through the threat of incarceration and clawbacks of executives’ compensation and bonuses."
One-third of malpractice cases for death or permanent disability began with an errant or delayed diagnosis, making it the biggest cause of serious harms among medical errors.
Misdiagnoses in treatments for "big three" conditions – cardiovascular events, cancers and infections – comprise 74% of all serious harms from diagnostic errors, according to a new study published Thursday in Diagnosis.
The study also found that 34% of malpractice cases for death or permanent disability began with an errant or delayed diagnosis, making it the biggest cause of serious harms among medical errors.
"We know that diagnostic errors happen across all areas of medicine. There are over 10 thousand diseases, each of which can manifest with a variety of symptoms, so it can be daunting to think about how to even begin tackling diagnostic problems," said study lead author David Newman-Toker, MD, director of the Johns Hopkins Armstrong Institute Center for Diagnostic Excellence, in remarks accompanying the report.
"Our findings suggest that the most serious harms can be attributed to a surprisingly small number of conditions. It still won’t be an easy or quick fix, but that gives us both a place to start and real hope that the problem is fixable," he said.
Sifting through reams of malpractice insurance claims in the national Comparative Benchmarking System database, the researchers analyzed all 11,592 diagnostic error cases between 2006 and 2015 that resulted in $1.8 billion in malpractice payouts over the decade.
"We use malpractice claims to track this issue because there aren’t many measures for diagnostic error. It’s not so much that they are prone to litigation- it is that they often result in significant harm and that can lead to litigation," Newman-Toker said.
They found that misdiagnoses were the most common, catastrophic and costly medical mistakes. Specifically, diagnostic errors that led to death or permanent disability were linked with misdiagnosed cancers (37.8%), vascular events (22.8%) and infections (13.5%) — which led the researchers to refer to them as the "big three."
Within those "big three" areas, the researchers identified 15 specific conditions that combined account for nearly half of all the serious, misdiagnosis-related harms.
The top conditions in each category are stroke, sepsis and lung cancer, respectively. Other most-commonly misdiagnosed conditions include heart attack, venous thromboembolism, aortic aneurysm and dissection, arterial thromboembolism, meningitis and encephalitis, spinal infection, pneumonia, endocarditis, and breast, colorectal, prostate and skin cancers.
The median age of the patients with errant diagnoses was 49, and more than half were female.
For children and young adults under age 20, harms most often were from missed infections (27.6%) rather than vascular events (7.1%) or cancers (9.1%). The reverse was true for middle aged and older adults.
Half of the most-severe harm cases ended in patient death and the other half resulted in permanent disability, the researchers report.
The claims data show that failures of clinical judgment caused more than 85% of the misdiagnosed cases. The researchers said those findings demonstrates that health systems must do more to support clinicians' bedside diagnoses, improve access to specialists, nurture clinician teamwork, and encourage patient engagement in the diagnoses.
The Hopkins researchers also found that 71% of the diagnostic errors took place in either in outpatient clinics, where misdiagnoses were often cancer-related, or emergency departments, for missed infections and vascular events.
Newman-Toker acknowledged a "built-in bias" in the malpractice cases because malpractice attorneys target cases, such as cancer, "since there's usually more of a paper trail."
To account for the bias, the researchers looked at earlier studies that used nonclaims data that still found that roughly three-quarters of diagnostic error cases were associated with the big three disease categories.
Kyle Marcotte of Jacksonville Beach admitted to using rural hospitals in a scheme that kicked back more than $50 million in insurance reimbursements for urine tests.
The owner of a Florida substance abuse treatment center pleaded guilty Tuesday to his role in a pass-through billing scheme that used rural hospitals to launder millions of dollars, the Department of Justice said.
Kyle Ryan Marcotte, 36, pleaded guilty to one count of conspiracy to commit money laundering and agreed to forfeit $10.2 million. His sentencing date has not been set, DOJ said.
According to DOJ, Marcotte, the owner of a substance abuse treatment facility in Jacksonville Beach, Florida. In 2015, Marcotte sent his patients' urine samples to a lab that retuned 40% of the insurance reimbursements to Marcotte.
The lab owner then arranged with the managers of Campbellton–Graceville Hospital and Regional General Hospital Williston in Florida to have the testing billed to private insurers through the rural hospitals at a better reimbursement under the hospitals' in-network contracts, DOJ said.
Attempts by HealthLeaders' to contact officials at Campbellton–Graceville Hospital and Regional General Hospital Williston for comment were not successful.
Marcotte also admitted that he brokered deals with other substance abuse treatment centers to have their urine tests billed through the two hospitals in exchange for Marcotte receiving 10% of the insurance reimbursements. The other rehab centers received 30% of the reimbursements, DOJ said.
The lab owner, who was not identified by DOJ, then acquired Chestatee Hospital, in Dahlonega, Georgia, and other rural hospitals, and Marcotte continued to supply samples from his rehab facility and brokered deals with other substance rehab facilities that used those hospitals, DOJ said.
The reimbursements were sent from the hospitals to the lab, which sent them to two companies Marcotte controlled, North Florida Labs and KTL Labs.
Marcotte used the reimbursements from KTL Labs to pay $50 million in kickbacks to at least 88 companies and people operating other rehab facilities who involved in the scheme. The total amount of money involved in the laundering scheme was $57.3 million, DOJ said.
Kidney disease accounts for about $114 billion, or 20%, of all traditional Medicare spending each year.
President Donald Trump on Wednesday launched an initiative that he says could save thousands of lives each year by increasing the transplantable kidney supply, expanding home-based dialysis options, and reducing kidney failure with proactive, preventive care.
"Today we are taking ground-breaking action to bring more hope to millions of Americans suffering from kidney disease. It's a big deal," Trump said Wednesday during a signing ceremony for "Advancing American Kidney Health."
"I've spoken to people (on dialysis). They say the work is so intense, The time is enourmous that they spend. it's like a full time job for people," Trump said. "These patients, their loved ones and for all those impacted by kidney disease, I am here to say we are fighting by your side and we are determined to get you the best treatment anywhere in the world."
Trump said that providing incentives for organ donors and streamlining the kidney procurement and management process could mean that as many as 17,000 additional people could receive kidney transplants, while 11,000 additional people could receive heart, lung, and liver transplants.
"That would be up to 28,000 American lives saved every year, and that numberr could be quite a bit higher if it works the way we anticipate it work," Trump said.
Trump said the initiative could generate as much as $4.2 billion in savings each year because the cost of kidney transplants are significantly lower than the long-term costs of kidney dialysis.
As part of the executive order, the Center for Medicare and Medicaid Innovation will release aproposed required payment model and four optional payment models designed to incentivize preventative kidney care, home dialysis, and kidney transplants.
More than 37 million people suffer from chronic kidney disease and more than 726,000 have end-stage renal disease. There are nearly 100,000 Americans waiting on the list to receive a kidney transplant, and kidney disease ranks as the ninth leading cause of death in America, HHS said.
Kidney disease accounts for about $114 billion, or 20%, of all traditional Medicare spending each year, but of the more than 100,000 people who begin dialysis to treat end-stage renal disease each year, one in five will die within a year, HHS said.
"Decades of paying for sickness and procedures in kidney care, rather than paying for health and outcomes, has produced less-than-satisfactory outcomes at tremendous cost," said HHS Secretary Alex Azar, telling the crowd at the signing ceremony that his father suffered from kidney failure.
"Through new payment models and many other actions under this initiative, the Trump Administration will transform this situation and deliver Americans better kidney health, more kidney treatment options, and more transplants," he said.
As part of the executive order, HHS has called for: reducing the number of Americans developing end-stage renal disease by 25% by 2030; having 80% of new ESRD patients in 2025 either receiving dialysis at home or receiving a transplant; and doubling the number of kidneys available for transplant by 2030.
Carmen Peralta, MD, executive director of the Kidney Health Research Collaborative, and CMO at kidney care provider Cricket Health, said it was "exciting to see CMS encourage innovation in a kidney care system that has simply failed patients for too long, while costs have skyrocketed."
"For far too long, the most profitable thing in kidney care has been to place a patient on in-center dialysis," she said. "But what's best for patients is intervening sooner — with early diagnosis, care management to slow progression, support for home dialysis, and time to consider dialysis alternatives such as transplants or conservative care."
The Executive Order also calls for HHS to:
Launch a public awareness campaign about chronic kidney disease, which 40% of American patients do not know they have.
Reform organ procurement and management to increase the transplantable kidney supply.
Expand support for living donors by paying for lost wages and childcare expenses.
HHS will also encourage the development of wearable or implantable artificial kidneys, through cooperation between developers and the Food and Drug Administration, and provide support for KidneyX, the public-private partnership between HHS and the American Society of Nephrology.
Two of the three judges on the panel signaled some sympathy for the arguments raised by the Texas-led group of plaintiff states who challenged the law.
A three-judge panel that heard oral arguments Tuesday afternoon on the legal status of the Affordable Care Act appeared sympathetic to the reasoning that led a lower court to declare all of the sweeping healthcare legislation invalid.
Judges Jennifer Walker Elrod and Kurt Engelhardt, the two judges on the panel who were appointed by Republican presidents, made comments and asked questions that may have signaled a likeliness to agree with at least some of the arguments raised by the Texas-led group of 18 plaintiff states that challenged the law's constitutionality in light of Congress zeroing out the tax penalties tied to the ACA's individual mandate.
However, Engelhardt also questioned why the case that will determine the future of the ACA was being litigated in a courtroom, instead of debated and voted on in Congress.
"There's a political solution here that you, various parties are asking this court to roll up its sleeves and get involved in. Isn't that exactly the point?" Engelhardt said during an exchange with an attorney representing the U.S. House of Representatives. "Isn't that why the Senate isn't here?"
The courts should not become "the taxidermist for every legislative big-game accomplishment that Congress achieves," Engelhardt added.
During a briefing with reporters after the hearing, Robert Henneke, general counsel at the Texas Public Policy Foundation, which represents two Texas men who've joined the plaintiffs, said the judges appear ready to declare the entire ACA invalid and let lawmakers chart a path forward.
"The greater lesson is that the judges today seem very focused on staying consistent with the law and faithful to their job to uphold the Constitution, but not to come in as a super legislative body to just rewrite the Affordable Care Act," Henneke said.
"Where Congress made a mistake [was] in the way that they created the Affordable Care Act and tied everything to the individual mandate," he added.
"Today's job by the court of appeals is to call balls and strikes and constitutionality and leave it to the Congress and to our state leadership to actually address healthcare policy that will restore choices, doctors, decreased costs, improve access to care for the millions of Americans like my clients that have been injured by the Affordable Care Act," he said.
In rebuttal, a California-led coalition of 20 intervening states and the District of Columbia, recently joined by the U.S. House of Representatives, told the appellate panel that U.S. District Judge Reed O'Connor's ruling was flawed.
"The entire Affordable Care Act can cooperate without the individual mandate," California Solicitor General Samuel Siegel told the court, according to CNN, adding that if Congress had wanted to eliminate the law in its entirety it could have done so.
Although a decision by the appellate court could take months, the ruling—whatever the outcome—is expected to be appealed to the U.S. Supreme Court, which could hear arguments and rule on the case amid the 2020 presidential campaign.
Henneke rejected arguments that Congress never intended to repeal the ACA in its entirety when it zeroed out the individual mandate tax penalty in 2017.
"What they were doing was just passing a tax bill," he told reporters. "So, I disagree with the argument that Congress was purposefully addressing the substantive aspects of the Affordable Care Act," he said. "But it just so happens, the consequences of their actions is what has left Obamacare here today as unconstitutional."
Beyond the questions surrounding the legal status of the ACA, the intervening states said a judicial nullification of the law would wreak chaos for the nation's healthcare system.
They said that more than 20 million people would lose healthcare coverage gained through the Medicaid expansion and Marketplace individual policies created under the ACA, and that important patient projections, such as a ban on restricting coverage for pre-existing conditions, would be eliminated with the law's demise.
The appellate court also considered the legal standing of the intervening states, who had argued that, if O'Connor's ruling was allowed to stand, it would eliminate the Medicaid expansion under the ACA and would cost them about $418 million over a decade.
The third judge on the panel, Carolyn Dineen King, appointed in 1979 by President Jimmy Carter, a Democrat, kept quiet throughout the proceedings.
HealthLeaders editor Jack O'Brien contributed to this report.
