While still reading the fine print, stakeholders say they're pleased that CMS has taken steps to update the 30-year-old laws.
Key stakeholders are offering praise in their early reviews of proposals to update the Stark Law and Anti-kickback Statute unveiled Wednesday by the Centers for Medicare & Medicaid Services.
American Medical Association President Patrice A. Harris, MD, said the nation's largest physicians association "is still assessing the full scope of (Wednesday's) proposal," but was "pleased to see that the administration has acknowledged a need for policy revisions in response to potential barriers that impede the delivery of patient-centric care."
"The AMA has previously called on the administration to modify the regulations in order to facilitate the move to value-based care," Harris said in prepared remarks.
"Currently, the Stark Law and anti-kickback statute can have a negative impact on the ability of physicians to assist with coordination because they inhibit collaborative partnerships, care continuity, and the engagement of patients in their care," he said.
Rick Pollack, president and CEO of the American Hospital Association applauded CMS "for putting patients first and taking action to modernize the rules so they support, rather than hinder, the teamwork among healthcare providers."
"When health care providers are able to work together to coordinate care, it is patients that benefit the most," Pollack said. "For far too long, a group of out-of-date regulations has created unnecessary roadblocks to the kind of collaboration and coordination that enables caregivers to meet all of their patients’ health care needs, whether in the hospital, the doctor’s office or their own homes."
The CMS proposal would create new and permanent exceptions to the 30-year-old Stark Law for value-based arrangements, permitting physicians and other providers to try innovating solutions without fear that their legitimate efforts to coordinate care might violate the law, according to an agency fact sheet. Those new exceptions would apply for Medicare and non-Medicare populations alike.
"The proposed rules provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients," Health and Human Services Secretary Alex Azar said in a media release. "The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse."
The HHS Office of Inspector General proposal would create three new safe harbors for certain forms of remuneration among eligible participants in value-based arrangements and make other changes, according to an OIG fact sheet.
Both CMS and OIG are soliciting public comments on the details of their proposals and related matters.
Ted Okon, executive director of the Community Oncology Alliance called the proposed reforms "an important first step towards making the dream of paying for cancer care based on value a reality."
However, he also warned that the proposed reforms could "accelerate the trend toward hospital acquisitions of community oncology practices and providers."
"COA is very concerned about hospitals taking advantage of changes to Stark Law and Anti-Kickback Statute to further monopolize cancer care and referrals," Okon said. "COA is hopeful that CMS and HHS will continue efforts to combat this, including site neutral payments and addressing misguided public policies that have driven the growth of hospital-based cancer care, such as the 340B Drug Pricing Program."
Clif Gaus, president and CEO of the National Association of ACOs, said the nation's ACOs "strongly support the administration’s efforts to enhance value-based care, giving ACOs and other models tools needed to succeed, improving regulatory certainty, and reducing administrative burden."
Gaus said administration officials on Wednesday confirmed that the new proposals do not supersede or override current HHS waivers for ACOs participating in the Medicare Shared Savings Program.
"NAACOS would encourage HHS to underscore this positive news and clarify that these new proposals build upon and give additional flexibility for today's ACOs," Gaus said.
NAACOS has asked HHS for additional clarity on patient sharing data, and how waivers apply to other models is welcomed.
Farzad Mostashari, MD, CEO and founder of the Aledade physician-led ACO network, and the former national coordinator for health information technology at HHS, said he was "glad to see the clarification of existing waivers to encourage more providers to adopt value-based and advanced payment models."
"Cooperation between providers to better coordinate and manage patient care is critical to the success of value-based arrangements for patients and providers alike," Mostashari said. "That said, it’s important that these rules safeguard against misuse by clinically integrated networks and provider groups who seek to control referral patterns and ultimately increase costs."
Researchers suggest that a cap on per-resident funding could rechannel money toward community-based physician training.
Capping Medicare Graduate Medical Education funding at $150,000 per resident could free nearly $1.3 billion that could be used to alleviate physician shortages in underserved areas, a new study in JAMA Internal Medicinesuggests.
"Our study suggests Medicare GME may be overpaying some hospitals up to $1.28 billion annually," study lead author Candice Chen, MD, MPH, said in comments accompanying the study.
"Those funds could be redirected and used to strengthen the physician workforce, especially in underserved areas," said Chen, an associate professor of health policy and management at the George Washington University Milken Institute School of Public Health.
The researchers looked at cost reports to calculate GME payments to hospitals from 2000 through 2015. They found that GME annual funding rates for teaching hospitals can vary by more than $75,000 per resident. In 2015, for example, 25% of hospitals receiving less than $105,761 while 25% received more than $182,233 per resident.
The researchers then calculated the savings if Medicare capped GME payments at $150,000 per year, which is the rate used for the Teaching Health Center Graduate Medical Education (THC) program, which trains residents in community health centers, and other community-based settings in underserved areas.
Chen said residents trained under the THC GME program are more likely to enter primary care, and practice in rural and underserved areas. Funding for the program dries up in mid-November unless Congress appropriates more money.
Medicare's current funding mechanisms for GME have resulted in some teaching hospitals – often located in urban areas – receiving a disproportionate share of the money. Residents who train at these big city hospitals tend to remain in urban settings, Chen said.
"Our study suggests that the savings produced by capping all hospitals at the THC GME rate would add up enough to expand the THC program by tenfold," Chen said.
Atul Grover, MD, PhD, executive vice president of the Association of American Medical Colleges, said his organization has "several concerns about this recommendation."
"The most critical being that the authors fail to adequately distinguish between the purposes of Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments and fail to recognize the impact of $1 billion in annual Medicare reductions," Grover said in an email exchange with HealthLeaders.
"These cuts would have a devastating impact on patients and communities, reducing access to the critical services teaching hospitals provide, such as trauma centers, burn units, neonatal intensive care units, and other specialized and standby services," Grover said.
"Additionally, while we agree that the Teaching Hospital Center (THC) GME program is an important, targeted tool for training physicians, HRSA estimates that the GME rate used for the THC GME program covers the full costs incurred by THCs when training residents," Grover said.
"Medicare DGME payments to teaching hospitals only cover 21% of the training costs. At a time when our growing and aging population is driving a physician shortage of up to 46,900 to 121,900 by 2032, it makes little sense to slash funding for vital care and services available almost exclusively at teaching hospitals and destabilize a system that has produced high-quality doctors and other health professionals for more than 50 years and is widely regarded as the best in the world," he said.
Chen acknowledged that the study does not look at how much it actually costs to train residents at particular hospitals, or if some hospitals have characteristics that make it costlier to provide GME.
She called capping the Medicare GME payment rate "a limited reform."
"More comprehensive approaches to GME reform would involve restructuring payment and increasing accountability for these publicly funded training programs," she said.
The study found that 90% of hospitals with palliative care are in urban areas, and 17% of rural hospitals with fifty or more beds provide palliative care.
Access to and quality of hospital-based palliative care in the United States has more to do with geography than need, a new state-by-state report card finds.
The report – America's Care of Serious Illness: 2019 State-by-State Report Card on Access to Palliative Care in Our Nation's Hospitals – found "persistent gaps in access" across the nation for the estimated 12 million adults and more than 400,000 children living with chronic illnesses such as cancer, dementia, heart disease and kidney disease.
The study found that 90% of hospitals with palliative care are in urban areas, and only 17% of rural hospitals with fifty or more beds report palliative care programs.
"As is true for many aspects of healthcare, geography is destiny. Where you live determines your access to the best quality of life and highest quality of care during a serious illness," said Diane E. Meier, MD, director of the Center to Advance Palliative Care, which compiled the report.
"The aging of the baby boomer generation is contributing to a growing population of patients in need who live for years with serious and chronic illness. The need to improve the quality of their health care is therefore urgent," Meier said.
The report card found robust growth in palliative care teams at hospitals, with 72% of U.S. hospitals with 50 or more beds having palliative care teams. That's up from 53% in 2008 and just 7% in 2001. These hospitals 87% of the nation's inpatients.
Meier credited many of the advances in palliative care access and quality to a growing palliative care workforce, changes in reimbursements, evidence-based quality initiatives, and enhanced clinical training.
"We want to acknowledge that progress does not happen in a vacuum," she said. "Over the last few years, we have seen growing support from federal and state officials and private sector leaders, as well as continued work from organizations in the field."
"These efforts have contributed to an environment in which more stakeholders recognize the value of palliative care and have the tools to implement it," she said.
Despite this overall growth, the 2019 grade for the nation is a B, just as it was in 2015, owing to the large swaths of the country that still have limited access to palliative care, the report said.
"Many gaps remain in access," Meier said. "Access to palliative care in U.S. hospitals depends on where you live and the type of hospital to which you are admitted."
The report found that larger, not-for-profit hospitals were more likely to provide palliative services than were for-profit hospitals.
"Larger hospitals are probably more likely to provide palliative care programs because the size of the hospital and volume of patients can support a full interdisciplinary team," she said.
As for why for-profit hospitals are less likely to offer palliative care services, Meier said "the reasons are unknown."
"However, there are studies that have shown that for-profit hospitals have a higher emphasis on providing services that are immediately profitable to the hospital," she said, pointing to a study that CAPC published in Health Affairs which found that for-profit hospitals were also less likely to provide other high-value, but low-revenue services to patients.
"Palliative care provides significant cost savings to a hospital, but that's not the same as bringing in revenue," she said.
As for what could entice for-profit hospitals to take up palliative care, Meier said changes to Medicare's Conditions of Participation for hospitals that "would require accountability for access to high-quality care for patients with serious illness across all types of hospitals."
In addition, Meier recommended "payment reform recognizing and rewarding quality of care and outcomes important to patients, instead of the current fee for service financial incentives driving volume and procedures."
Meier was asked to identify a "common thread" among the states that scored well on the report card.
"There are some differences in the makeup of the hospitals within states or regions, although these differences may not fully explain the differential prevalence rates," she said.
"For example, the three regions that received A grades (New England, East North Central, and Mid-Atlantic) all have the highest proportions of non-profit hospitals in the United States and subsequently, the lowest rates of for-profit hospitals," she said. "More than 85% of the hospitals in those regions are non-profit compared to 71% nationally."
Meier said the two regions that scored the lowest and received C grades (East South Central and West South Central) have disproportionately more for-profit hospitals than other regions.
"More than one-quarter of the hospitals in East South Central and more than one-third in West South Central are for-profit, compared to only 16% of hospitals nationally," she said. "Rural hospitals are also less likely to provide palliative care and in East South Central, rural hospitals account for 13% of the hospitals with 50 or more beds compared to only 4% nationally."
In a new poll, most adults ages 50-80 expressed concerns about the quality of care that comes with remote provider visits.
Older adults and seniors are not exactly embracing telemedicine, but that doesn't mean they're unwilling to try it, a new survey shows.
A survey of 2,250 adults aged 50 to 80 conducted by the National Poll on Healthy Aging found that only 4% of respondents had had a video-based telehealth visit with a provider via smartphone or computer in the past year.
Their reviews were mixed.
More than 70% of the respondents voiced concerns that providers couldn't do a physical exam over a webcam or smartphone camera, and 68% suggested that remote care wouldn't be as good. With a small minority who had used telehealth, 58% said office visits offered better care quality, and 48% were concerned about privacy.
Meanwhile, more than half of all those polled didn't know if their health providers offer telehealth visits at all. More than 80% of older adults polled expressed at least one concern about seeing a doctor or other provider virtually rather than in person. And 47% worried about getting the technology to work.
But 64% said they'd be willing to try telehealth in some situations, for instance if they got sick while traveling and 58% said they'd be receptive to telemedicine if they needed follow-up on a previous office visit.
With that in mind, Preeti Malani, MD, the poll's director and a professor of internal medicine at Michigan Medicine, said targeting certain types of telehealth visits could help older adults get comfortable with the idea.
"Telehealth won't replace in-person medical examinations completely, but for situations where in-person visits aren't essential, they can save time and resources for patients and providers alike," Malani said.
"Providers shouldn't assume older adults aren't receptive to virtual visits, but they should understand and work to overcome some of the reasons for hesitation," she said.
Of the one-third of the respondents whose providers don't offer telemedicine, 48% said they'd be willing to try it for primary care, but fewer were willing to use it for specialty or mental health services.
Beginning in 2020, Medicare Advantage health maintenance organizations will reimburse providers for telemedicine. In addition the Veterans Administration has increased access to telemedicine, along with some Medicaid and commercial plans.
Alison Bryant, senior vice president of research for AARP, said the poll findings suggest that providers need to do a better job informing older patients that telemedicine is an option, explaining how it works, and how it could benefit them.
"Many older Americans can benefit from being able to get care through telehealth without long trips to their doctor's office," Bryant said. "Telehealth allows people to schedule health-related appointments, request prescription refills, and link to healthcare providers when time or distance is a barrier. It can also support family caregivers who are taking care of their loved ones."
Of the 548 ACOs that cared for 10.1 million beneficiaries, 66% saved money and 37% saved enough money to earn bonuses.
The Medicare Shared Savings Program generated $1.7 billion in total savings in 2018, the Centers for Medicare & Medicaid Services said this week.
Of that, Medicare netted $739 million, after paying out shared savings bonuses, and collecting shared savings loss payments from ACOs that participated in the Pathways to Success Shared Savings Program, CMS Administrator Seema Verma said in a commentary posted in Health Affairs.
"ACOs that received shared savings payments had decreases in inpatient, emergency room, and post-acute care spending and utilization, while ACOs that increased spending relative to their targets tended to show increases in these areas," Verma said.
ACOs in the shared savings and risk-based models saw reductions in per-enrollee spending. However, ACOs that took on downside risk generated more savings than ACOs that did not, with an average $96 reduction in spending per enrollee, compared with $68 per enrollee in ACOs that did not take on risk.
"This trend is one of the reasons that the greater accountability for ACOs included in Pathways to Success, along with greater flexibility for them to innovate, will lead to better, more efficient care for Medicare beneficiaries," Verma said.
Among the highlights singled out by Verma:
ACOs led by physicians, which are generally "low revenue", continued to outperform hospital-led ACOs, which tend to be "high-revenue" and which provide inpatient and outpatient services.
Low-revenue ACOs in 2018 saw an average reduction in spending relative to targets of $180 per beneficiary, compared to just $27 for high-revenue ACOs.
ACOs had an average quality score of almost 93%;
ACOs that joined the program in 2016 or 2017 improved their quality measure performance by an average of 27% in 2018;
ACOs that earned shared savings retained an average of 48% of their generated savings;
ACOs in their second contract period saved more than twice as much per beneficiary compared to ACOs in their initial contract period.
Clif Gaus, president and CEO of the National Association of ACOs, said CMS' findings "put to rest any notion that ACO savings are 'modest' and illustrate the strong performance of the leading Medicare alternative payment model."
"Given time, we know ACOs save money and provide benefit for patients and taxpayers," he said.
The robust savings generated by the program comes amid fears that enthusiasm is cooling with ACOs.
CMS released the 267-page final rule for Pathways to Success under the Medicare Shared Savings Program in late December, and announced that applications to participate in the program would be due in February.
NAACOS and other stakeholders in January had asked CMS to extend by at least one month the application deadline..
CMS reported in July that only 518 ACOs are currently in the program, a decline from 2018 participation rates.
"Recent data from CMS indicate a potential drop in ACO participation. Today’s results prove the Shared Savings Program was doing very well before last year's changes by CMS," Gaus said.
NAACOS has also challenged the metric to measure ACO savings. Rather than relying on CMS-set benchmarks, NAACOS said Medicare should use "counterfactual" data "that compares Medicare spending to what spending would be like in the absence of ACOs."
"Researchers at Harvard University, the Medicare Payment Advisory Commission andNAACOs have all done such work. All showed ACOs are lowering Medicare spending by 1% to 2%, which translates into tens of billions of dollars of reduced Medicare spending when compounded annually," NAACOS said.
The researchers warned that these potentially lethal cardiac infections pose an increasing threat to hospital patients admitted for other diseases.
"In the past, infective endocarditis was associated with rheumatic heart disease and most often caused by bacteria in the mouth," study lead author Abel Moreyra, MD, a professor of medicine at Rutgers, said in comments accompanying the study.
"However, new risk factors, such as intravenous opiate abuse, compromised immune systems, hemodialysis and implanted heart devices have emerged," Moreyra said.
In 2007, the American Heart Association revised guidelines and recommended antibiotics only for patients at high risk for infection.
The researchers looked to find how the revised guidelines changed infection rates. They analyzed 21,443 records of people who were diagnosed with infective endocarditis in New Jersey hospitals from 1994 to 2015.
The researchers were surprised to find that, beginning in 2004, there was a significant decline in the number of patients hospitalized with infective endocarditis as the primary diagnosis for their reason for admission.
Coupled with that was a significant increase in the number of patients developing the infection in the hospital, or a secondary diagnosis.
In total, 9,191 people were hospitalized with infective endocarditis as the primary diagnosis and 12,252 with secondary diagnosis, the researchers found
The decline in primary diagnosis was attributed by researchers to improved dental care and the rarity of rheumatic heart disease, where streptococcus plays a key role in the infection.
"However, 60% of infective endocarditis that developed after admission were caused by a different microorganism, staphylococcus bacteria, which is abundant in hospitals and implicates health care as a possible source of infection," Moreyra said.
The researchers believe that, by identifying the different time trends of primary and secondary diagnosis of infective endocarditis, the findings can help hospitals tailor different strategies for the prevention of this potentially lethal infection.
The defendants allegedly schemed to improperly obtain a $164 million FHA-backed loan to build a for-profit hospital in Texas.
A Texas hospital, a Tennessee-based healthcare company, and three healthcare executives have been accused of improperly obtaining and misusing federal loans targeted for hospital construction in underserved areas, the Department of Justice said.
The alleged violations of the False Claims Act and the Financial Institutions Reform, Recovery, and Enforcement Act were leveled against Lakeway (TX) Regional Medical Center, LLC; Franklin, Tennessee-based Surgical Development Partners, LLC; Surgical Development Partners' CEO G. Edward Alexander; Frank Sossi; and John Prater, federal prosecutors said.
Lakeway Regional Medical Center suffered financial difficulties soon after the 106-bed, for-profit hospital opened in 2012, and defaulted on a $164 million HUD loan in August 2013, according to The Austin American Statesman.
In September 2016, HUD sold the hospital for $50 million to BaylorScott&White Health in 2016.
The federal complaint alleges that the defendants schemed to improperly obtain a Federal Housing Administration-backed loan to build the Lakeway hospital.
Prosecutors allege that the scheme delayed refunds to investors who had cancelled their investments to make it appear as if the project satisfied cash-on-hand covenants required to close the loan.
Prosecutors also allege that the defendants improperly doled out project funds.
"We will do what it takes to ensure that the American people are not left footing the bill when borrowers fail to comply with FHA program requirements intended to protect the public fisc," U.S. Attorney John Bash of the Western District of Texas said in prepared remarks.
BaylorScott&White issued a statement noting that "these allegations have nothing to do with Baylor Scott & White Health or the hospital it operates as Baylor Scott & White Medical Center – Lakeway. These allegations relate to matters that occurred long before we acquired the operations of this hospital."
In June, four development companies and their executives involved in the Lakeway project agreed to pay the federal government $1.1 million to settle allegations that they improperly obtained and distributed money from the FHA loan.
Average deductibles now at $1,655, double the average of a decade ago.
Even in a strong economy, cost growth for employer-sponsored health insurance continues to easily outstrip wage growth and inflation in the overall economy, survey results released today show.
Employers' and workers' costs for premiums continue to rise faster than wages (3.4%) and was more than double the rate of inflation (2%) in the overall economy over the same period, the survey of more than 2,000 small and large businesses found.
"The single biggest issue in health care for most Americans is that their health costs are growing much faster than their wages are," KFF President and CEO Drew Altman said in a media release.
"Costs are prohibitive when workers making $25,000 a year have to shell out $7,000 a year just for their share of family premiums," Altman said.
On average, workers are contributing $6,015 toward the cost of family coverage for the 153 million Americans who receive health insurance through an employer-based plan. Employers paid the bulk of the costs, KFF found.
Since 2009, average family premiums have increased 54% and workers’ contribution have increased 71%, several times faster than wages (26%) and inflation (20%), KFF reported.
The survey also found that:
82% of covered workers have a deductible in their plan, similar to last year and up from 63% a decade ago.
The average single deductible now stands at $1,655 for workers who have one, similar to last year’s $1,573 average but up sharply from the $826 average of a decade ago.
These two trends result in a 162% total increase in the burden of deductibles across all covered workers over the past decade.
28% of all covered workers, including 45% of those at small employers with fewer than 200 employees, are now in plans with a deductible of at least $2,000, almost four times the share who faced such deductibles in 2009.
13% of workers now face deductibles of at least $3,000.
Workers at lower-wage employers are nearly half as likely as other workers to be covered by their employer.
HHS says MA plan options, benefits, and enrollment are expected in increase in the coming year.
With Medicare's open enrollment period looming on October 15, the Centers for Medicare & Medicaid Services announced this week that Medicare Advantage premiums for 2020 will drop by an average of 23% when compared with premiums in 2018.
Since 2017, the average monthly Medicare Advantage premium has fallen by 27.9%, and the 2020 estimates represent the lowest average monthly premium for a Medicare Advantage plan has been since 2007, CMS said.
In addition, Health and Human Services Secretary Alex Azar said the 24 million people who are projected to enroll in Medicare advantage will have more plans and benefits to choose from.
"That is what CMS has been delivering with its improvements to Medicare Advantage: lower costs, more options, and benefits tailored to patients' needs," Azar said in a media release.
"This proven record of success—decreasing premiums in both Medicare Advantage and Medicare Part D—contrasts with proposals for a total government takeover of healthcare, which would destroy options such as Medicare Advantage that seniors increasingly choose," he said.
Medicare Advantage enrollment has increased by more than 30% since 2017. CMS projects that Medicare Advantage enrollment, currently at 22.2 million, will increase to 24.4 million in 2020, representing about one third of the 60 million people in the Medicare program.
CMS Administrator Seema Verma used the announcement to take a swipe at Medicare For All proposals touted by some Democratic presidential candidates.
"On the contrast, proposals for more government through Medicare for All or a public option, would only harm the progress we have made to protect and strengthen the Medicare program for future generations," Verma said.
Along with a previously announced 13.5% declinein the average monthly basic Part D premium, Verma said beneficiaries have saved about $2.65 billion in Medicare Advantage and Part D premium costs since 2017.
Critics of MA say it actually costs the federal government more money because MA enrollees generally are healthier, use fewer healthcare services, and would accrue lower costs for the program if they were enrolled in traditional Medicare.'
Katherine Holt, associate director of the Center for Medicare Advocacy, says that MA plans have been able to lower premiums by narrowing provider networks, and "aggressively managing care through difficult prior authorization requirements."
Holt says the Trump administration is "engaged in a concerted effort to steer beneficiaries to Medicare Advantage, whether or not a private plan is the right choice for their coverage needs."
"More choices are not necessarily better choices," Holt says. "Beneficiaries should carefully weigh the value of Medicare Advantage plan extra benefits against the need for significant access to medical services as available in Original Medicare."
The projected average monthly basic Part D premium of $30 in 2020 is the lowest the Part D basic premium has been since 2013.
According to CMS:
MA average monthly premiums are expected to drop 14% to $23 in 2020, down from $26.87 in 2019.
Beneficiaries will have about 1,200 new MA plans operating in 2020 than in 2018.
The average number of MA plan choices per county will increase from about 33 plans in 2019 to 39 plans in 2020. This represents an increase of 49% since 2017.
The continued decline in Medicare Advantage and Part D premiums over the past three years is estimated to save taxpayers nearly $6 billion in the form of lower Medicare premium subsidies.
America's Health Insurance Plans said beneficiaries are flocking to MA "because it delivers better services, better care and better value than traditional Medicare."
"Medicare Advantage continues to outperform and offer better coverage and care than traditional Medicare, even though the average payment to MA plans is equivalent to costs for traditional Medicare, AHIP said.
Children with two subtypes of cardiomyopathy — hypertrophic or restrictive — are now dying on the waitlist at a rate 4-6 times higher than before the new criteria went into effect in 2016.
Recent attempts to improve waiting times and lower mortality rates for children needing heart transplants may have made the problem worse, new research suggests.
In fact, mortality increased for some types of heart disease.
"Changes were made to prioritize sicker children with fewer treatment options — for instance, kids with congenital heart defects — but the reality we’re showing is that since the criteria change, transplant centers are using more listing status exceptions, essentially short-circuiting the intended benefit," said senior author Brian Feingold, MD, medical director of pediatric heart failure and heart transplantation at UPMC Children’s Hospital of Pittsburgh, in comments accompanying the study.
The new policy de-prioritizes children with cardiomyopathies. Because of that, the UPMC researchers found, clinicians are getting more exceptions to the policy for their cardiomyopathy patients, especially a subtype called dilated cardiomyopathy, so that patients will retain the highest listing status.
Since the revamped criteria was established, exceptions for dilated cardiomyopathy rose by more than 13-fold, yet the study shows high priority status makes no difference in the survival rates of these patients, the researchers found.
However, children with two other subtypes of cardiomyopathy — hypertrophic or restrictive — without an exception, are now dying on the waitlist at a rate 4-6 times higher than before the new criteria went into effect, the researchers found.
"We can't prove causality here, but it would seem that restrictive and hypertrophic cardiomyopathy patients have been disadvantaged by the criteria change," Feingold said.
"They're prioritized downward under the umbrella of cardiomyopathy, likely inadvertently, while children with congenital heart defects have not been able to benefit due to increased exception use," he said.
Feingold said the reason why patients with different subtypes of cardiomyopathy are faring so differently under the new guidelines is that children with dilated cardiomyopathy tend to be better candidates for implanted blood pumps called ventricular assist devices (VADs).
Considered a type of life support, VADs place patients higher on the waitlist. They also allow patients to rehabilitate, even leave the hospital, while waiting for a transplant.
Feingold said he hopes the findings will prompt discussions about improving waitlist criteria for children awaiting heart transplants.
"The chronic shortage of organ donors means that we must strive to optimize organ allocation as much as possible," he said. "It's very difficult to know all of the downstream effects of policy decisions like these, so we should continue to tweak and observe until we get it right."
