The final rule will require drug makers to post the list price if that price is equal to or greater than $35 for a month's supply.
The pharmaceutical industry will soon be required to post the costs of pricey prescription drugs in direct-to-consumer TV ads for drugs covered by Medicare and Medicaid under a final rule unveiled today by the federal government.
"We're telling drug companies today you've got to level with people what your drugs cost. Put it in the TV ads," Health and Human Services Secretary Alex Azar said at a media availability Wednesday morning.
"Patients have a right to know, and if you're ashamed of your drug prices, change your drug prices," he said. "It's that simple."
The final rule, which takes effect 60 days after its publication in the Federal Register, will require drug makers to post the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month's supply or the usual course of therapy.
"Why did we pick $35 as the threshold? We picked that because it approximates insurance plans average copayment for a preferred-brand drug," Azar said. "The public is already accustomed to paying roughly this amount for drugs out of pocket. In the absence of new information, we might presume that patients will pay this amount for a drug."
The rule will only apply to TV ads, Azar said, because that's where the pharmaceutical industry concentrates its advertising spend.
"Of the $5 billion that the pharmaceutical industry spends per year in advertising, $4 billion is on television ads. It is currently the highest-impact area for their advertising activity," Azar said.
"We decided at this moment to focus there, where they believe they are getting the highest impact and spending the most money," he said. "The door is open to other platforms and other forms of advertising as we move forward and as we evaluate the impact of behavioral change caused by this requirement."
According to HHS, the 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy.
Nearly half (47%) of Americans have high-deductible health insurance plans, which means they often pay the list price of a drug until they have spent through their deductible.
PhRMA 'Concerned'
Pharmaceutical Research and Manufacturers of America President and CEO Stephen J. Ubl said the drug industry is "concerned that the administration's rule requiring list prices in direct-to-consumer (DTC) television advertising could be confusing for patients and may discourage them from seeking needed medical care."
"We support providing patients with more transparency about medicine costs, which is why our member companies voluntarily began directing patients to links to comprehensive cost information in their DTC television advertising," Ubl said. "After speaking with patients across the country, we learned that patients prefer this approach."
Azar, a former top executive at Eli Lilly & Co., said the pharmacuetical industry's call to provide a link in the TV ad to pricing information on a website "would not be compliant with the requirements of this rule."
"The PhRMA proposal that they simply do that is not acceptable," he said. "They put $4 billion a year in TV advertising, because that is where people are getting their information. The transparent pricing information should be in a place and location where they are also pitching the patient to talk to their doctor and incur expenses."
Drug makers will police themselves
Azar said HHS would rely on the drug companies to police themselves.
"Enforcement of this rule will be done the way enforcement is traditionally done in the television marketing space with drug ads, which is actually by competitors," he said. "If a drug company fails to include the required information in their ad, then a competitor may bring a Lanham Act action against them for a deceptive trade practice."
"There are very large legal practices built on pharma companies suing each other for violations of the Deceptive Trade Practices provisions of the Lanham Act, so this will be a quite effective mechanism of enforcement," he said.
Ubl also raised concerns about the "operational challenges" of final rule, "particularly the 60-day implementation timeframe," and he added that the final rule "raises First Amendment and statutory concerns."
Azar rejected suggestions that the pricing requirement would infringe on free speech rights.
"We don’t believe there is any problem with requiring people in their ads, where they are telling patients to go to the doctor's office, to ask a doctor about a drug, for patients to be informed of what the price of that very product is," he said.
"We think it is a fundamental right to know, whether the drug they're being pitched is a $50 drug or a $5,000 drug before they are asked to spend hundreds of dollars on a doctor's appointment to ask about that drug."
Azar said the pricing disclosure will "prompt a more knowledgeable discussion between the doctor and the patient." He noted the car manufacturers have been required to post sticker prices on cars for more than 50 years.
The price disclosure rule was first brought forward in May 2018 as part of President Donald Trump's American Patients First blueprint to reduce drug cost and lower patients' out-of-pocket expenses.
Azar said HHS received 147 comments about the proposed rule during the comment period, but that no big changes were made for the final rule.
ONC was asked to consider slowing down the two-year implementation window, but one committee member blasted a 'dysfunctional' healthcare system as technology laggards.
A Senate committee during a status update Tuesday on the proposed rules for electronic health records under the 21st Century Cures Act offered mixed messages to policymakers charged with implementing those provisions.
Sen. Lamar Alexander (R-Tenn.) chairman of the Senate Health, Education, Labor and Pensions Committee, repeatedly raised concerns about past mistakes with HIT adoption under the Meaningful Use initiatives and warned that the pace of implementation under the 21st Century Cures Act was too hasty. He urged policymakers to proceed with caution.
"My major concern is to give the administration the advice my piano teacher used to give me before a recital," Alexander told officials from the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health Information Technology.
"She would say 'Lamar, play it a little slower than you can play it. You're less likely to make a mistake.' That's pretty good advice," he said. "We don’t need to set a record time to get there with an unrealistic time line."
The Centers for Medicare & Medicaid Services in February proposed that Medicaid, Medicare, and other government-funded healthcare programs provide enrollees with immediate electronic access to medical claims and other health information by 2020.
Alexander suggested that ONC slow down the two-year implementation window with "a more phased approach" that starts with U.S. core data for interoperability, "do that well within those first two years, and then take a second step."
"You had a common clinical data set that set in 2015 and many people still haven’t been able to comply with that. Now you're having an updated data set. You're not only asking for that information. You're asking for all of the other information within a two-year period," Alexander said.
Don Rucker, MD, ONC's national coordinator for HIT, told the committee "the difference between the U.S. core data of interoperability and the common data set is we are adding in clinical notes and what is called metadata."
"All the core technical provisions and the testing about the core data for interoperability, that is the part that is computable," Rucker said. "We have evidence that the vast majority or providers, both hospitals and physicians, have access to that software today."
Following up on Alexander's remarks, Committee Ranking Member Patty Murray (D-Wash.) asked Rucker about the consequences of delaying provisions of the Act that dealt with information blocking.
"The main risk, fundamentally, to the extent this delayed or prevented, the American public is not in charge of their healthcare," Rucker said. "They're paying more for their care. They're not getting as good care as they could get, and fundamentally they're not in control of their care."
Sen. Mike Braun (R-Ind.) used his five minutes to rail against a "dysfunctional" healthcare system that has to be goaded by the government to adopt technologies that other sectors of the economy have been using for decades.
"Most industries would not be having hearings because there is transparency and there is competition and there is embracing of the technology," Braun told the committee. "I hated to hear that within the medical sector it's the only place where we see neutral or maybe negative annual gains in the use of technology. It begs the question: What is wrong with the industry itself?"
Braun, who referred to himself as a "Main Street conservative," said the problem is not with the government, but with the private sector.
"I lay the burden not here in the Senate, but on the shoulders of the industry itself," he said. "If you are cloaking and making this so difficult to get simple things like interoperability, we're hearing about blocking information, that is so far out of the mainstream from all other industries."
"I want the industry to hear what I've been saying all along. Get with it or you are going to be changed radically with all kinds of approaches that are based on frustration," he said.
The milestone continues a long-term trend that has shifted the distribution of physicians away from ownership of private practices.
Employed physicians outnumber self-employed physicians for the first time in the United States, according to an updated studyon physician practices by the American Medical Association.
"Transformational change continues in the delivery of healthcare and physicians are responding by reevaluating their practice arrangements," AMA President Barbara L. McAneny, MD, said in amedia release.
Employed physicians were 47.4% of all patient care physicians in 2018, up 6% points since 2012.
Self-employed physicians were 45.9% of all patient care physicians in 2018, down 7% points since 2012.
Such a dramatic shift is not unprecendented. Older AMA surveys show the share of self-employed physicians fell 14% points during a six-year span between 1988 and 1994.
Given the rate of change in the early 1990s, it appeared a point was imminent when employed physicians would outnumber self-employed physicians, but the shift took much longer than anticipated.
The AMA's researchers said that history suggests that "caution should be taken in assuming current trends will continue indefinitely."
The majority of patient care physicians (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor. Although this share fell from 60% in 2012, the trend away from physician-owned practice appears to be slowing since more than half of the shift occurred between 2012 and 2014, the study said.
At the same time, there was an increase in the share of physicians working directly for a hospital or in a practice at least partly owned by a hospital.
Physicians working directly for a hospital were 8% of all patient care physicians, an increase from 5.6% in 2012. Physicians in hospital-owned practices were 26.7% of all patient care physicians, an increase from 23.4% in 2012.
In the aggregate, 34.7% of physicians worked either for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29.0% in 2012.
Younger physicians and women physicians are more likely to be employed. Nearly 70% of physicians under age 40 were employees in 2018, compared to 38.2% of physicians age 55 and over.
Among female physicians, more were employees than practice owners (57.6% vs. 34.3%). The reverse is true for male physicians, more were practice owners than employees (52.1% vs. 41.9%).
As in past AMA studies, physicians’ employment status varied widely across medical specialties in 2018.
The surgical subspecialties had the highest share of owners (64.5%) followed by obstetrics/gynecology (53.8%) and internal medicine subspecialties (51.7%).
Emergency medicine had the lowest share of owners (26.2%) and the highest share of independent contractors (27.3%). Family practice was the specialty with the highest share of employed physicians (57.4%).
Most physicians still work in small practices, but this share has fallen slowly but steadily since 2012. In 2018, 56.5% of physicians worked in practices with 10 or fewer physicians compared to 61.4% in 2012.
The AMA report said the transition has been driven primarily by the shift away from very small practices, especially solo practices, in favor of very large practices of 50 or more physicians.
The new study is the latest addition to the AMA's Policy Research Perspective series that examines long term changes in practice arrangements and payment methodologies.
Complexity, competition, and inexperience are keeping MMCOs away from the ACA Marketplace.
Goading more Medicaid managed care organizations to participate in the Affordable Care Act's Marketplace could lower premiums for enrollees, according to a new study commissioned by the Robert Wood Johnson Foundation.
In 15 states where marketplace premiums are higher than the national average, Medicare MCOs offer little or no coverage, according to the report, which was compiled by the Urban Institute.
In the 10 states with the lowest average benchmark premiums, all have MMCOs broadly offering marketplace coverage, the report found.
The report suggests that some insurers see Medicaid as more attractive than the Affordable Care Act marketplaces because Medicaid offers plans more policy stability, clearer delineation of rules, and less burdensome regulation.
"As policymakers grapple with affordable ways to expand coverage, they may consider ways to incentivize Medicaid insurers to expand their offerings," said Mona Shah, senior program officer at the Robert Wood Johnson Foundation.
"If Medicaid managed care plans offer coverage to more people and in more places, it could help protect consumers from higher healthcare costs," Shah said.
Medicaid MMCOs expressed concern about the different marketing and pricing tasks that would be necessary for success in the marketplaces. In other words, the MMCOs said entering the ACA Marketplaces was too complex.
Among the obstacles:
Marketplace insurers must compete for enrollees, which some Medicaid insurers do not have experience with because they are assigned enrollees or exclusive territories by some state Medicaid programs.
Marketplace insurers face more financial risk, because marketplace rules and conditions have changed drastically from year to year, making it more difficult for insurers to predict how costly their enrollees will be, and leading some insurers to lose money on their marketplace business.
Marketplace insurers need more sophisticated actuaries to price plans, whereas states often set Medicaid insurers' capitated rates.
Marketplace insurers must be able to collect premiums from consumers, whereas most Medicaid plans are available without a premium.
Marketplace insurers must obtain special insurance licenses and maintain larger capital reserves to cover any unexpected financial losses.
The Urban Institute researchers identified policy changes that could make the ACA's marketplaces more attractive to MMCOs. For example, the MMCOs have shown interest in a recent Medicaid buy-in program that allows residents to pay premiums to "buy in" to Medicaid.
Under that plan, the coverage for consumers who enroll in Medicaid buy-in might be the same as someone who would otherwise sign up for marketplace coverage.
However, the organizational requirements that would apply to sellers of these two types of plans could end up being very different. If a Medicaid buy-in program used Medicaid's less stringent requirements, it could prompt organizations not currently offering marketplace plans to offer new coverage options to consumers.
LHN CEO Mark Medley will take over Poore's portfolio after he leaves at the end of this month.
Lutheran Health Network Regional President Mike Poore is stepping down at the end of May after less than two years at the Fort Wayne, Indiana-based health system.
In a letter to employees, published byInside Indiana Business, Poore said he has planned to stay longer, but after several weeks of contemplation, "I’ve decided that this is the right time for me to return home."
He called the move "the right decision for me and for my family at this time in our lives."
LHN CEO Mark Medley will take over Poore's portfolio after he leaves at the end of this month.
"Over the next few weeks, I’ll be transitioning my responsibilities to Mark Medley and I’ll be working with our hospital and network leadership teams to ensure a smooth transition," Poore said.
Poore has served as president and CEO of LHN since June 2017, when parent company Community Health Systems ousted CEO Brian Bauer. Poore relinquished the CEO title earlier this year to focus on long-term planning.
Poore had served as vice president of operations for Franklin, Tennessee-based Community Health Systems Professional Services Corp. and CEO of hospitals and health systems in Georgia, North Carolina and Texas.
Lutheran Health Network has had its share of drama in recent years. Amid financial hardship, CHS considered selling the network in 2016, and Bauer was fired in 2017. A group of physicians then tried unsuccessfully to acquire the network, the chief medical officer was fired, and two other prominent physicians resigned.
In 2018, St. Joseph Hospital CEO Karen Fordham resigned after working in the Lutheran Health Network just seven months, having been accused of saying Bauer "should be shot and killed for what he did."
Bauer was sued by CHS for allegedly using privileged information to seek new ownership and help competitor IU Health establish its presence in the city, as the News-Sentinelreported last August.
DOJ 'upon further consideration' explains why it abandoned it partial defense of the ACA.
The Trump Administration this week detailed its argument for a judicial repeal of the Affordable Care Act.
"The district court correctly ruled that, in the absence of any revenue-raising provision, the individual mandate can no longer properly be upheld as a tax and is therefore unconstitutional," Assistant U.S. Attorney Joseph H. Hunt wrote in the50-page brieffiled Wednesday with the 5th U.S. Circuit Court of Appeals.
Hunt argued that, absent the mandate, "Congress would not have intended to retain the guaranteed-issue and community-rating provisions, which Congress expressly found depended on the mandate, or the rest of the ACA, which involves numerous other interdependent provisions likewise designed to work together to expand health-insurance coverage and to shift healthcare costs."
"Moreover, once those core provisions are excised, the balance of the ACA cannot continue to operate as intended," Hunt wrote.
"The desired interactions between these provisions cannot be achieved once the individual mandate and the guaranteed-issue and community-rating provisions are excised. Instead of rewriting the statute by picking and choosing which provisions to invalidate, the proper course is to strike it down in its entirety," Hunt said.
District Judge Reed O'Connor's decision last December went much further than the DOJ had urged, declaring the entire ACA invalid, as the Texas-led coalition of plaintiff states had requested. Now that an appeal is pending at the Fifth Circuit, however, the DOJ has decided that it agrees with the plaintiffs' argument and O'Connor's decision after all.
The DOJ had argued in District Court proceedings last fall that most of the sprawling healthcare legislation should remain intact, even if the ACA's individual mandate were to be struck down in light of Congress zeroing out its tax penalty. Only the ACA's community-rating and guaranteed-issueprovisions—which protect consumers with preexisting conditions—should fall with the mandate, the DOJ had argued.
"In the district court, the Department of Justice took the position that the remainder of the ACA was severable," Hunt wrote, "but upon further consideration and review of the district court’s opinion, it is the position of the United States that the balance of the ACA also is inseverable and must be struck down."
Democrats Seethe
House Speaker Nancy Pelosi (D-Calif.) said the DOJ brief was the latest effort in the "continuing Republicans' monstrous campaign to destroy pre-existing condition protections and Americans' access to affordable healthcare."
"There is no viable legal argument and no moral defense for the devastation the Trump Administration is asking the court to inflict on Americans' healthcare," Pelosi said in prepared remarks.
Pelosi said the House Democrats next week would vote on the Protecting Americans with Pre-existing Conditions Act to strengthen and reinforce these life-saving protections.
In the meantime, Pelosi said, "the Trump Administration owes the American people answers for why it is seeking to rip away protections for pre-existing conditions and cause such vast suffering for families across America."
A new report says transitioning the nation's $3.5 trillion healthcare system to a single-payer system 'could be complicated, challenging, and potentially disruptive.'
The Congressional Budget Office said Wednesday that government spending under a single-payer health system "would increase substantially."
However, the report didn't say how much a single-payer system would cost, nor did it say if total national healthcare spending under single-payer would be higher or lower than under the existing system.
"Government spending on healthcare would increase substantially under a single-payer system because the government (federal or state) would pay a large share of all national health care costs directly," the report said.
"Shifting such a large amount of expenditures from private to public sources would significantly increase government spending and require substantial additional government resources," CBO said, but the cost "would depend on the system's design and on the choice of whether or not to increase budget deficits."
"Total national healthcare spending under a single-payer system might be higher or lower than under the current system depending on the key features of the new system, such as the services covered, the provider payment rates, and patient cost-sharing requirements," CBO said.
The report deferred on the single-biggest question about single-payer: How much would it cost?
"This report does not address all of the issues that the complex task of designing, implementing, and transitioning to a single-payer system would entail, nor does it analyze the budgetary effects of any specific bill or proposal."
According to the CBO analysis, about 29 million people under the age of 65—that's 11% of the population—are uninsured in an average month. While a single-payer system would significantly reduce the numbers of uninsured, exactly by how much would depend upon the system's design.
"For example, some people (such as noncitizens who are not lawfully present in the United States) might not be eligible for coverage under a single-payer system and thus might be uninsured," CBO said.
Regardless, CBO said that because healthcare spending accounts for about 18% of the nation's gross domestic product, any changes to the delivery system "could significantly affect the overall U.S. economy."
"The transition toward a single-payer system could be complicated, challenging, and potentially disruptive," CBO said. "To smooth that transition, features of the single-payer system that would cause the largest changes from the current system could be phased in gradually to minimize their impact."
Federal prosecutors claim that, under Newsome's guidance, HMA pressured emergency department physicians to admit patients without regard to medical necessity.
Gary D. Newsome, the former CEO of now-defunct Health Management Associates LLC, will pay $3.46 million to settle kickback and false claims allegations made in a whistleblower lawsuit, the Department of Justice said.
Federal prosecutors claim that HMA, under Newsome's guidance, pressured emergency department physicians to admit Medicare patients without regard to medical necessity, and that the care provided to the beneficiaries should have been provided in a less costly outpatient or observation setting.
Prosecutors also alleged that Newsome's HMA paid EmCare, a company that provided physicians to staff HMA hospital EDs, to recommend admission when patients should have been treated on an outpatient basis.
"A physician's healthcare decisions should be driven by what is in the patient's best interest, not by what helps line a provider's pockets," said Barbara Bowens, acting U.S. Attorney for South Carolina. "The U.S. Attorney's Office will not tolerate false claims based on unnecessary hospital admissions, which drive up healthcare costs and can harm patients."
As part of the alleged scheme, Newsome saw that HMA made bonus payments to EmCare ED physicians and tied EmCare's retention of existing contracts and receipt of new contracts to increased admissions of patients who came to the ED.
Newsome served as CEO of HMA from September 2008 through July 2013. HMA, which was based in Naples, Florida, was acquired by Community Health Systems Inc. in January 2014, after the alleged conduct at HMA occurred.
Newsome's attorney, Barry Sabin, said his client "is pleased that this matter is now behind him."
"In reaching a settlement, Mr. Newsome continues to emphatically deny the government's claims," said Sabin, a partner at Latham & Watkins. "He is pleased to now end the uncertainty and high expense of protracted litigation."
HMA and EmCare have already settled their liabilities.
In September 2018 HMA entered into a civil settlement under which it paid $61.8 million. Simultaneously, HMA entered into a Non-Prosecution Agreement with the Criminal Division's Fraud Section under which it paid a $35 million monetary penalty.
In addition, an HMA subsidiary that formerly owned one hospital pled guilty to a single count of conspiracy to commit healthcare fraud, and paid a $3.25 million fine. In December 2017, EmCare paid $29.6 million to resolve these allegations.
This settlement resolves a lawsuit originally filed in the U.S. District Court for the District of South Carolina by Jacqueline Meyer, a former employee of EmCare, and J. Michael Cowling, a former employee of HMA, under the whistleblower provisions of the False Claims Act.
Meyer and Cowling will receive approximately $725,000 from the settlement.
Proposed rule will increase transparency of changes of ownerships for AOs with Medicare deeming authority to safeguard patient safety.
The Centers for Medicare & Medicaid Services on Tuesday unveiled a proposed rule requiring greater transparency when ownership changes occur at accrediting organizations.
The proposed rule establishes a process AOs with Medicare-approved accreditation programs must follow if there is a sale, transfer, and/or purchase of assets related to the ownership of an AO. CMS said the new rule is needed to ensure the effectiveness of accreditation programs.
"Accrediting Organizations are an important partner in our oversight of healthcare facilities across the country," CMS Administrator Seema Verma said in a media release. "Today we are reinforcing our commitment to patient safety by proposing policy that would require accrediting organizations to notify CMS when the organization makes a change in ownership."
"This rule builds on earlier steps we've take to strengthen federal oversight of accrediting organizations and ensure patients are receiving high quality, safe care at our nation's healthcare facilities," Verma said.
CMS grants AOs "deeming authority" to affirm that a healthcare facility's safety standards meet or exceed those of Medicare. Only facilities and suppliers that have been deemed by state or AO surveyors to meet CMS' standards may receive payments from Medicare.
Current CMS regulations governing AOs do not require them to provide CMS advanced notice of pending changes of ownership. CMS is first notified of an AO ownership change when an AO, under new leadership, applies for renewal of its agreement to CMS or it voluntarily notifies the agency.
This proposal would require AOs to notify CMS when they are contemplating or negotiating a change of ownership, CMS said.
CMS would also require prospective new owners to submit documentation and information confirming their ability to effectively perform the required accreditation tasks after the change of ownership takes place.
CMS said the proposal does not impede the sale of an AO, but instead gives CMS the ability to approve or deny the accreditation programs that are to be transferred as part of the sale or transfer.
Tuesday's proposal is the latest in a series of actions CMS has taken to improve oversight of AOs. In 2018, CMS said it would AO performance data online and also began a more streamlined, efficient way to assess AOs' ability to ensure that facilities and suppliers comply with CMS requirements.
In December, CMS raised questions about potential conflicts of interest between Medicare accrediting organizations and the healthcare facilities they monitor.
"We are concerned that the practice of offering both accrediting and consulting services–and the financial relationships involved in this work–may undermine the integrity of accrediting organizations and erode the public’s trust," Verma said at the time.
The query was expected to include an examination of The Joint Commission, the nation's largest hospital accrediting organization. In a media statement in December, The Joint Commission said it is reviewing CMS's requests for comment, but said it is confident in the integrity of the "firewall" between its consulting and accrediting divisions.
"The Joint Commission recognizes the importance of assuring the integrity of the accreditation process, which we accomplish by prohibiting any sharing of information about consulting services for individual organizations with anyone involved in accreditation," the statement read.
The agency also issued a Request for Information seeking comment on the financial relationships between CMS-approved AOs and the healthcare facilities they review and monitor.
As part of this process, CMS will determine whether revisions should be made to the AO application and renewal process to identify actual, potential, or perceived conflicts of interest.
Phase 1 challenged innovators to submit a short proposal on approaches that could enable the design of new artificial kidney devices, improving quality of life.
The Department of Health and Human Services, partnering with the American Society of Nephrology, has picked 15 teams to take part in the first phase of Kidney Innovation Accelerator, or KidneyX.
Through cash awards and other incentives, KidneyX hopes to accelerate the development of innovative medical products and approaches to diagnose, prevent, and improve care for kidney diseases.
Phase 1 challenged innovators to submit a short proposal on approaches that could enable the design of new artificial kidney devices, extending life and improving quality of life.
"Building an artificial kidney is going to be a highly collaborative process, and Redesign Dialysis is one step in building the community of innovators," Sandeep Patel, MD, HHS KidneyX Director, said in a media release. "We are excited with the initial response, which tells us we're only scratching the surface so far."
Of the 165 submissions received, the submission topics ranged from innovations in vascular access and fluid filtration, to innovations in hemodialysis and biosensors. The submissions were scored by more than 40 technical reviewers comprised of patients and experts from government, industry and academia.
The top scoring submissions were then judged by a panel of nine experts in medicine, biomedical science and engineering, and commercialization. Fifteen winners were awarded monetary prizes of $75,000 each.
"The winning proposals address a broad range of potential improvements to dialysis and highlight the fact that there is more work to be done to change the status quo. Millions of patients are waiting," said John Sedor, MD, chair of the KidneyX Steering Committee.
Phase 2 of Redesign Dialysis will start accepting submissions this fall and is open to all, including Phase 1 winners.
In Phase 2, innovators will be asked to demonstrate functional prototypes that can replicate some or all kidney functions. Up to three winners will be awarded $500,000 each.
Prize Winners
A non-invasive, wearable telehealth device to detect thrombosis and monitor vascular access health of arteriovenous fistulas and grafts in hemodialysis patients
University of Alabama -- Birmingham.
Air Removal System for a Wearable Renal Therapy Device
Qidni Labs, Inc.
Atomically Precise Membranes (APM) for High-Flux and Selective Removal of Blood Toxins
Temple University.
Development of a Dialysate- and Cell-Free Renal Replacement Technology, Curion Research Corporation, University of California Los Angeles, and University of Arkansas.
Development of an Automated Multimodal Sensor to Improve Patient Outcomes in Hemodialysi Outset Medical, Inc.
Drug-Eluting Electrospun Hemodialysis Graft
Biosurfaces, Inc., Beth Israel Deaconess.
Fluo Medical - Non-Invasive Venous Waveform Analysis (NIVA) for Volume Directed Kidney Failure Management
Stanford University.
Improving intra-dialytic removal of protein-bound uremic toxin removal using binding competitors
Mount Sinai Renal Research Institute.
Intracorporeal Ultrafiltration System & Intracorporeal Hemodialysis System
The Kidney Project.
JEM™ - Sensor Enabled Hemodialysis
Access for Life, Inc.
New Kidney Grafts
Miromatrix Medical, Inc.
Nitric Oxide-Eluting, Disposable Hemodialysis Catheter Insert to Prevent Infection and Thrombosis
University of Michigan.
RenalTracker
Binnovate Digital Health BV.
The Ambulatory Kidney to Improve Vitality (AKTIV) & Rethinking Dialysis Vascular Access
University of Washington, Center for Dialysis Innovation.
Utilizing Optical Interrogation Methods for Early Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Stanford University.
The Phase 1 prize winners were announced during the inaugural KidneyX Summit scheduled on Monday and Tuesday at the U.S. Institute of Peace in Washington, D.C.
Prize winners will present their solutions to an audience of industry leaders within government, mechanical and bioengineering, investment, and medical product development.
(Correction: The initial media release from HHS failed to include Curion Research Corporation among the prize recipients.)
