Sunday, July 28, 2019

$540K for 14 weeks of Dialysis: Overwhelming Out of Network Costs, Better Dialysis Hydration Monitoring

Sticker Shock

From NPR, National Public Radio, Illinois, FM 91.9 UIS

First Came Kidney Failure. Then There Was The $540,842 Bill For Dialysis

Sovereign Valentine and his wife, Jessica, wait as a dialysis machine filters his blood. Before finding a dialysis clinic in their insurance network, the Valentines were charged more than a half-million dollars for 14 weeks of treatment.

Sovereign Valentine and his wife, Jessica, wait as a dialysis machine filters his blood. Before finding a dialysis clinic in their insurance network, the Valentines were charged more than a half-million dollars for 14 weeks of treatment.
TOMMY MARTINO/KAISER HEALTH NEWS


Several days after NPR published and aired the following story, Fresenius Medical Care, one of the two largest dialysis providers in the U.S., agreed to waive its $524,600.17 charge.

For months, Sovereign Valentine had been feeling progressively run-down. The 50-year-old personal trainer, who goes by "Sov," tried changing his workout and diet to no avail.

Finally, one Sunday, he drove himself to the hospital in the small town of Plains, Mont., where his wife, Jessica, happened to be the physician on call. "I couldn't stop throwing up. I was just toxic."

It turned out he was in kidney failure and needed dialysis immediately.

"I was in shock, but I was so weak that I couldn't even worry," he said. "I just turned it over to God."

He was admitted to a nearby hospital that was equipped to stabilize his condition and to get his first dialysis session. A social worker there arranged for him to follow up with outpatient dialysis, three times a week. She told them Sov had two options, both about 70 miles from his home. They chose a Fresenius Kidney Care clinic in Missoula.

A few days after the treatments began, an insurance case manager called the Valentines warning them that since Fresenius was out of network, they could be required to pay whatever the insurer didn't cover. The manager added that there were no in-network dialysis clinics in Montana, according to Jessica's handwritten notes from the conversation. (The insurance company disputes this and says that its case manager told her there were no in-network dialysis clinics in Missoula.)

Jessica repeatedly asked both the dialysis clinic staff and the insurer how much they could expect to be charged, but couldn't get an answer.

Then the bills came.

Patient: Sovereign Valentine, 50, a personal trainer in Plains, Mont. He is insured by Allegiance through his wife's work as a doctor in a rural hospital.

Total bill: $540,841.90 for 14 weeks of dialysis care at an out-of-network Fresenius clinic. Valentine's insurer paid $16,241.73. The clinic billed Valentine for the unpaid balance of $524,600.17.

Service provider: Fresenius Medical Care, one of two companies (along with rival DaVita) that control about 70% of the U.S. dialysis market.

Medical treatment: Hemodialysis at an outpatient Fresenius clinic, three days a week for 14 weeks.

What gives: As the dominant providers of dialysis care in the U.S., Fresenius and DaVita together form what health economists call a "duopoly." They can demand extraordinary prices for the lifesaving treatment they dispense — especially when they are not in a patient's network. A 1973 law allows all patients with end-stage renal disease like Sov to join Medicare, even if they're younger than 65 — but only after a 90-day waiting period. During that time, patients are extremely vulnerable, medically and financially.

Fresenius billed the Valentines $524,600.17 — an amount that is more than the typical cost of a kidney transplant. It's also nearly twice Jessica's medical school debt. Fresenius charged the Valentines $13,867.74 per dialysis session, or about 59 times the $235 Medicare pays for a dialysis session.

When Jessica opened the first bill, she cried. "It was far worse than what I had imagined would be the worst-case scenario," she said.

Sov had a different reaction: "To me, it's so outrageous that I just have to laugh."

Dialysis centers justify high charges to commercially insured patients because they say they make little or no money on the rates paid for their Medicare patients, who — under the 1973 rule — make up the bulk of their clientele. But nearly $14,000 per session is extraordinary. Commercial payers usually pay about four times the Medicare rate, according to a recent study.

Dialysis companies are quite profitable. Fresenius reported more than $2 billion in profits in 2018, with the vast majority of its revenue coming from North America.

The discrepancy in payments between Medicare and commercial payers gives dialysis centers an incentive to treat as many privately insured patients as possible and to charge as much as they can before dialysis patients enroll in Medicare. It may also give dialysis centers an incentive to charge outlandish prices to the few out-of-network patients they see.

"The dialysis companies may think they can get closer to what they want from the health plans by staying out of network and charging these prices that are totally untethered to their actual costs," said Sabrina Corlette, a professor at Georgetown University's Health Policy Institute. "They have the health plans over a barrel."

One potential way to save costs on dialysis is to switch to a type that can be done at home, which involves infusing fluid into the abdomen. Called peritoneal dialysis, it is common in Europe but relatively rare in the U.S. In an executive order this month, President Trump announced new incentives to increase uptake of those options.

Brad Puffer, a spokesman for Fresenius Medical Care North America, said the company would not comment on any specific patient's situation.

"This is one example of the challenges that can arise from a complex healthcare system in which insurers are increasingly shifting the financial burden to patients," Puffer said in a written statement. "The insurance company should accurately advise patients of in- and out-of-network providers. It is the patient's choice when they receive that information as to which provider they select."

Resolution: As a physician, Jessica Valentine is savvy about navigating the insurance system. She knew it was important to find an in-network provider of dialysis. She and the insurance company case manager both searched on the insurer's online provider directory, she said, and were unable to find one. The problem may have been searching for a "provider" rather than a "facility" in the directory.

Jessica eventually wrote to the Montana insurance commissioner to inquire if the lack of a dialysis provider violated a requirement that insurers maintain an "adequate network" of providers.

With help from the state insurance commissioner, she learned that there was, in fact, an in-network dialysis clinic run by a nonprofit organization that had not turned up in her insurer's online search or the directory. She immediately arranged for Sov to start getting further dialysis there. But the bills with Fresenius, meanwhile, were adding up.

After a reporter made inquiries, a financial counselor at Fresenius told Jessica that the Valentines qualified for a discount of 50%, based on their income. That would still leave them a bill of $262,400.08.

"It's still a completely outrageous charge," Jessica said. "I want to pay what we owe and what's reasonable and what his care actually cost."

Unwilling to pay Fresenius more, Allegiance said Jessica should have found the in-network facility earlier. "There is always the potential for customers to misunderstand information about how their health plan works, especially in stressful situations," a spokesperson for Allegiance wrote.

Jessica is considering contacting a lawyer. If all else fails, the Valentines will consider filing for bankruptcy. A family doctor who works at a rural hospital, Jessica now understands why some of her patients avoid testing and treatment for fear of the cost. "It's very, very frustrating to be a patient, and it's very disempowering to feel like you can't make an informed choice because you can't get the information you need."

The takeaway: Dialysis is a necessary, lifesaving treatment. It is not optional — no matter a patient's financial situation.

Insurers are obligated to have adequate networks for all covered medical services in their plans, though "adequacy" is poorly defined.

So, if it looks like there isn't an in-network option within a reasonable distance — for dialysis or more basic services from orthopedists or dermatologists — keep digging. Keep in mind that dialysis clinics may be listed as "facilities" rather than "providers" in your directory.

If none are available, seek help from your state's insurance commissioner. Report your experiences — that's one way the commissioner can learn that the names listed in the directory aren't taking patients or are 50 miles away, for example.

If you have insurance through an employer, you can contact your benefits department to go to bat for you. If there is no in-network option, you should get a dispensation to go out of network at in-network rates and with in-network copayments.

If you receive a bill for out-of-network care, don't merely write the check. Ask for an itemized bill and review the charges. You can also ask your insurance company to negotiate with the provider on your behalf. See if the bill counts as a "surprise bill" under your state's law, in which case you could be "held harmless" from excessive charges.

And when all else fails, try to negotiate directly with the provider. They might have a financial assistance policy, or be willing to lower the cost significantly to avoid turning you over to a debt collector that would pay them pennies on the dollar.

NPR produced and edited the interview with Kaiser Health News' Elisabeth Rosenthal for broadcast. Nick Mott of Montana Public Radio provided audio reporting. The digital version of this story was updated July 22 to include a fuller explanation of the insurance company's account of what the Valentines were told about dialysis clinics in its network.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it here.




Dialysis Hydration Monitoring

From AZO Sensors

Noninvasive Sensor can Significantly Improve Dialysis


Removing fluid at the precise rate and stopping at the right time is very important for patients suffering from kidney failure and require constant dialysis.

This usually involves guess-work on how much water needs to be removed, and the patient also needs to be carefully monitored for sudden drop in blood pressure.

A present, no easy and reliable method is available to determine hydration levels in such patients, who number about half a million in the U.S. Conversely, a research team from Massachusetts General Hospital and MIT has designed a new, portable sensor that can precisely determine the hydration levels of patients using a method called nuclear magnetic resonance, or NMR, relaxometry.

A device like that would be useful for dialysis patients and also for people suffering from congestive heart failure. The device can also benefit athletes and elderly population who may be at risk of becoming dehydrated, stated Michael Cima, the David H. Koch Professor of Engineering in MIT’s Department of Materials Science and Engineering.

There’s a tremendous need across many different patient populations to know whether they have too much water or too little water. This is a way we could measure directly, in every patient, how close they are to a normal hydration state.

Michael Cima, Study Senior Author and Member of Koch Institute for Integrative Cancer Research, MIT

While the new device is predicated on the same technology as MRI (magnetic resonance imaging) scanners, it can achieve measurements in relatively less time and at a fraction of the cost of MRI. This is because imaging is not involved in this process.

The lead author of the paper is Lina Colucci, a former graduate student in health sciences and technology. The study has been reported in in the July 24th, 2019 issue of Science Translational Medicine.

Other study authors include MIT graduate student Matthew Li; MGH nephrologists Andrew Allegretti, Kristin Corapi, and Herbert Lin; MGH research fellow Xavier Vela Parada; Harvard Medical School assistant professor in radiology Matthew Rosen; and MGH Chief of Medicine Dennis Ausiello.

Hydration Status

Cima started working on this study around a decade ago, after he came to know that there was an urgent need for a noninvasive ad precise method to determine hydration levels. At present, the existing techniques are subjective, invasive, or inconsistent. Most often, physicians assess overload (hypervolemia) by several physical signs like assessing the jugular vein size, examining the ankles where water may collect, or pressing on the skin.

The MIT researchers decided to go for an entirely different technique, predicated on NMR. Earlier, Cima had established a company, known as T2 Biosystems, that utilizes tiny NMR devices to diagnose bacterial infections by examining blood samples of patients.

Cima later devised an idea to apply the devices to determine water content in tissue, and several years ago, the team received a grant from the MIT-MGH Strategic Partnership to conduct a minor clinical trial for tracking hydration. The researchers examined patients with end-stage renal disease who frequently underwent dialysis and also healthy controls.

One major objective of dialysis is to remove fluid from patients and bring them to their “dry weight”. Dry weight is the weight at which the fluid levels of patients are improved. However, it is very difficult to determine a patient’s dry weight. As such, dry weight is estimated by physicians based on physical signs and also via trial-and-error over many dialysis sessions.

The MIT/MGH research team demonstrated that quantitative NMR, which operates by determining a trait of hydrogen atoms known as T2 relaxation time, can enable relatively more precise measurements. The T2 signal determines the environment as well as the amount of hydrogen atoms, or water molecules, present.


The beauty of magnetic resonance compared to other modalities for assessing hydration is that the magnetic resonance signal comes exclusively from hydrogen atoms. And most of the hydrogen atoms in the human body are found in water molecules.

Lina Colucci, Study Lead Author and Former Graduate Student, Health Sciences and Technology, MIT

The investigators applied their new device to determine the level of fluid in patients both before and after they went through dialysis. The outcomes demonstrated that this method can possibly differentiate healthy patients from those requiring dialysis with just the initial measurement. Moreover, the measurement precisely demonstrated dialysis patients reaching closer to a usual hydration state over the duration of their therapy.

Additionally, the NMR measurements successfully detected the presence of surplus fluid within the body before conventional clinical signs—for example, the accumulation of visible fluid under the skin—were present. Doctors can use the sensor to establish when a patient has approached his or her actual dry weight, and this determination can be personalized during every dialysis treatment.

Better Monitoring

The scientists are now planning to conduct more clinical trials with dialysis patients. They believe that dialysis, which presently costs the U.S. over $40 billion per annum, would be one among the largest applications for this kind of technology. Such a monitoring can also prove useful for patients suffering from congestive heart failure, which impacts around 5 million people in the U.S, alone.


The water retention issues of congestive heart failure patients are very significant. Our sensor may offer the possibility of a direct measure of how close they are to a normal fluid state. This is important because identifying fluid accumulation early has been shown to reduce hospitalization, but right now there are no ways to quantify low-level fluid accumulation in the body. Our technology could potentially be used at home as a way for the care team to get that early warning.

Michael Cima, Study Senior Author and Member of Koch Institute for Integrative Cancer Research, MIT

According to Sahir Kalim, a nephrologist and assistant professor of medicine at Massachusetts General Hospital, the MIT approach is “highly novel.”

“The development of a bedside device that can accurately inform providers about how much fluid a patient should ideally have removed during their dialysis treatment would likely be one of the most significant developments in dialysis care in many years,” stated Kalim, who was not part of the research. “Colucci and colleagues have made a promising innovation that may one day yield this impact.”

In their analysis of the healthy control subjects, the investigators also observed that dehydration can possibly be detected. This would render the device handy for tracking elderly population, who usually become dehydrated since their sense of thirst reduces with age, or athletes participating in endurance events, including marathons. The team is now planning some upcoming clinical trials so as to test the capability of the novel technology to identify dehydration.

The study was funded by the MGH-MIT Strategic Partnership Grand Challenge, the Air Force Medical Services/Institute of Soldier Nanotechnologies, the National Science Foundation Graduate Research Fellowships Program, the National Institute of Biomedical Imaging and Bioengineering, the Koch Institute Support (core) Grant from the National Cancer Institute, and Harvard University.

Sunday, July 21, 2019

Expanding Home Dialysis, Push to Extend Medicare Coverage of Transplant Drugs, Improving Policy for Kidney Health

Kidney Dialysis

From Wall Street Journal, By Anna Wilde Mathews
CVS Begins Clinical Trial for Home-Dialysis Device

CVS holds exclusive U.S. rights to the HemoCare device, which was designed by the firm of Dean Kamen, the Segway inventor. PHOTO: CVS HEALTH



CVS Health Corp. CVS is making an ambitious move into kidney care, launching a clinical trial for a new home-dialysis device designed by the firm of Dean Kamen, the Segway inventor.

The company is delving into unusual territory for a drugstore and health insurer. The plan will make it a medical-device firm and a provider of dialysis, the complex blood-cleansing procedure vital to patients suffering from kidney failure. CVS holds exclusive U.S. rights to the HemoCare device, which was created by Mr. Kamen’s firm, Deka Research & Development Corp.


CVS will work to capitalize on an initiative announced last week by the Trump administration, which wants to move more dialysis into the home, rather than dialysis centers, where most U.S. patients currently get the procedure. Dialysis is covered by Medicare, including for patients under the age of 65. The care of patients with end-stage renal disease is a major cost for the program, amounting to around $35 billion in 2016, or roughly 7% of total spending under traditional Medicare.

The Department of Health and Human Services said increased use of home dialysis could reduce costs and “preserve or enhance the quality of care.”

Alan Lotvin, executive vice president at CVS, said the company is making a broader push into care for patients with kidney disease, including managing the care of those who aren’t yet eligible for dialysis. CVS plans to offer home dialysis services, both using the new device and a different method known as peritoneal dialysis, but it doesn’t expect to perform dialysis in its own facilities or stores, he said. The new device is expected to be leased or sold to other providers, he said.

“We think that this is a really important step forward for the care of patients,” Dr. Lotvin said.

CVS said the clinical trial of the HemoCare device focuses on demonstrating its safety and efficacy and winning approval from the Food and Drug Administration. The trial is expected to enroll approximately 70 patients throughout the country. It will compare the results for the device when it is operated by a nurse with what happens when the dialysis is performed at home by the patient and a partner. CVS said the trial is expected to be completed around the end of 2020, and the company aims to have the device in the market in late 2021.

“We’ve gone to extraordinary lengths to build safety systems focused on the idea that the device will be used by a patient” in the home, said Mr. Kamen, who is known as the inventor of the Segway electric two-wheeled people mover but has also helped create an array of other devices, several in the health-care category. He said the new home-dialysis device is designed to be simple and intuitive to operate.

CVS declined to comment on financial details of its deal with Deka. Mr. Kamen said that CVS helped fund the development of the device, and Deka will be paid a licensing fee based on “how successful they are in the marketplace.” Deka will oversee the device’s manufacturing, he said.

Kidney care is part of CVS’s effort to become a health-care provider for people with chronic conditions, a touchstone of its nearly $70 billion deal to acquire insurer Aetna Inc.

CVS is under pressure to show financial benefits and paths to growth tied to the deal, and its shares have been languishing in recent months after the company issued earnings projections for the year that fell short of investor expectations.

Dialysis patients often have multiple health problems, making their care far more complex than the types of procedures traditionally offered in retail clinics.

In entering the dialysis business, CVS will be taking on DaVita Inc. and Fresenius Medical Care North America, a subsidiary of a German company, which dominate the U.S. dialysis market. DaVita and Fresenius, which themselves offer home-dialysis options, have longstanding ties to kidney-care doctors who oversee the care of patients, analysts said.

“Nephrologists are everything,” said John Ransom, an analyst at Raymond James. “They’re the gatekeeper to where you go and what your plan of care is.”

Dr. Lotvin said CVS is well-positioned to compete in kidney care, pointing to the new technology of the device and its lack of the fixed cost of a center network, as well as relationships with health-care payers.




Kidney Transplant

From NPR, by JONEL ALECCIA

Lawmakers, Advocates Push To Extend Medicare's Coverage Of Kidney Transplant Drugs


On Wednesday, Alexis Conell will mark seven years since she received the kidney transplant that saved her life, but the 53-year-old Chicago woman isn't exactly celebrating.

Although the federal government paid most of the costs for her 2012 transplant, a long-standing Medicare policy halted coverage three years later for the drugs that keep her body from rejecting the organ.

So when Conell lost her job suddenly last September, she also lost her health insurance — and her ability to afford the 16 daily medications she needs to survive.

"I was terrified," she says. "All you're thinking is, 'I don't want to lose my kidney.'"

For nearly a half-century, Medicare has covered patients, regardless of age, who have end-stage renal disease, including paying the costs of kidney transplants and related care, which run about $100,000 per patient.

But coverage ends after 36 months for those younger than 65 who don't otherwise qualify for the program — and that includes payment for the vital immunosuppressive drugs that cost thousands per patient each month.

Last week's announcement of the Trump administration's overhaul of kidney care in the U.S. has reanimated an effort by a group of federal lawmakers and kidney care advocates to extend drug coverage.

"After a transplant, patients should not have to worry about whether they can afford the treatment needed to keep their transplanted kidney," Rep. Ron Kind, D-Wis., said in a statement.

For years, Kind has been among a bipartisan coalition in Congress championing legislation targeting kidney immunosuppressive drugs — to no avail.

The sticking point was price. A 2009 estimate by the Congressional Budget Office pegged the cost at $400 million over 10 years if the government were to extend lifetime drug coverage to those patients.

Two recent federal projections show that Medicare could actually save money — between $73.4 million and $120 million over a decade — by expanding payment for anti-rejection medications to help decrease the need for patients to get additional transplants or dialysis. Depending on financing, savings could reach $300 million in that period, suggested an estimate by the Centers for Medicare & Medicaid Services.

Armed with this data, the bipartisan coalition, led by Kind and Rep. Michael Burgess, R-Texas, a physician, is expected to introduce legislation by August that would narrowly extend Medicare's Part B program to provide drug coverage for kidney transplant patients who have no other option.

"We must ensure patients have access to immunosuppressant coverage to ensure the success of their transplant, which will keep costs down by decreasing the need for a re-transplant or further dialysis," said Kind.

Sens. Richard Durbin, D-Ill., and Bill Cassidy, R-La., are poised to introduce their own legislation, sources told KHN on background.

The efforts in Congress will hinge on whether the CBO agrees that paying for the medication would save the government money, advocates say. Even the new estimates by CMS suggest that changing the program would increase costs initially, with savings apparent only after a decade.

Dr. Emily Blumberg, president of the American Society of Transplantation, says there appears to be high-level support for change now. In championing the overhaul of U.S. kidney care policy, HHS Secretary Alex Azar has cited a personal tie, noting that his father suffered from kidney failure and received a transplant in 2014.

Azar said during the announcement last week that the Trump administration is supportive of the legislative efforts. "We are hoping Congress will work together with us to relieve that time limit so that we can support patients on immunosuppressants over the long term," he said.

On a call with reporters on Wednesday, Tonya Saffer, vice president for health policy at the National Kidney Foundation said that with the administration's backing, they're hopeful that this legislation might finally go somewhere. A key next step is analysis on what it would cost or save from the Congressional Budget Office. "There is a CBO score forthcoming," she said. "The legislation still needs to be introduced, but I know that the members are working with the Congressional Budget Office to score that legislation."

Nearly 100,000 patients are waiting for kidney transplants in the U.S. and about 10 people die each day because of an ongoing shortage of organs.

More than 56,000 Americans with functioning kidney transplants don't have Medicare coverage, according to data from the U.S. Renal Data System. About two-thirds pay for their medications through private insurance, Medicaid or other government programs, experts said.

But about one-third of those patients may have no other source of drug coverage, which can lead to missed doses, jeopardizing their new kidneys. A 2010 study found that nearly 70% of U.S. kidney transplant programs reported deaths or organ losses directly related to the high cost of anti-rejection drugs.

If Medicare drug coverage had been extended in 2015, it would have averted at least 375 kidney transplant failures that year alone, the latest analysis showed.

When transplants fail, patients can die — or they must return to dialysis — paid for by Medicare at a cost of about $90,000 per year, with a poor prognosis.

"It's a no-brainer that you should do this both from a moral and ethical and, now it sounds like, cost perspective," says Dr. Robert Gaston, a nephrologist at the University of Alabama-Birmingham who co-authored a call for coverage in an Institute of Medicine report two decades ago.

Conell battled end-stage renal disease for years before receiving her kidney transplant. When she lost her job abruptly last fall, she had to cancel scheduled medical appointments and lab tests.

She drained her savings, then nearly ran out of medication before she found a pharmaceutical firm program that provides the drugs she needs at a deep discount.

"If I had to pay full price for them, it would easily be $3,000 or more per month," Conell says.

When her unemployment benefits ended in April, Conell qualified for Medicaid, which covers her drugs for now. The stress has been unrelenting, says Conell, who spent a day last week in the emergency room with dangerously high blood pressure.

"I was trying to look for a job, worried about paying my bills. Ultimately, I'm worried about losing my kidney," she says, adding that the long-delayed legislation could solve the problem. "I think they should pass it, like, yesterday."





Kidney Health Policy

From JDSupra

President Trump Issues Executive Order Aimed at Kidney Health in America


On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health aimed at reducing the number of patients developing kidney failure, having fewer Americans receiving dialysis in dialysis centers, and making more kidneys available for transplant (the Order). The Order calls on the Secretary of HHS to, among other things, develop a payment model designed to identify at-risk patients earlier in disease development and increase home dialysis and kidney transplants. The Order also tasks the Secretary to reform regulations regarding the evaluation metrics for Organ Procurement Organizations (OPOs). These steps, and others, are set to roll out as early as 30 days from the Order.

The Order’s policy initiatives are three-fold. The first goal is to “prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care.” The second is to “increase patient choice through affordable alternative treatments for end stage renal disease (ESRD) by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys.” The third initiative is to “increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.” A press release by HHS added specifics to the President’s goals:

  • Reducing the number of Americans developing end-stage renal disease by 25 percent by 2030;
  • Having 80 percent 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.

HHS is tasked with developing new payment models and initiatives to implement the Order. Specifically, the Secretary is called upon to launch several initiatives to promote kidney disease awareness and support research regarding prevention and treatment. The Secretary shall also develop a payment model to test innovations in compensation for providers of kidney care services based on kidney patient cost and quality outcomes, with a focus on delaying or preventing the onset of kidney failure, preventing unnecessary hospitalizations, increasing the rate of transplants and creating incentives to provide care for Medicare beneficiaries who have advanced stages of kidney disease but who are not yet on dialysis. The Secretary shall also select a payment model incentivizing greater use of home dialysis and kidney transplants for Medicare beneficiaries on dialysis.

According to HHS’s press release, the Center for Medicare & Medicaid Innovation (CMMI) has responded to the Order by releasing a set of four optional payment models, expected to enroll more than 200,000 Medicare patients in arrangements that give providers new incentives for preventing kidney disease and managing kidney patients’ health in a more comprehensive and person-centered way. To provide more options for people with kidney failure, CMMI also announced a required payment model, known as ESRD Treatment Choices, which will enroll all dialysis providers in approximately half of the country and provide new incentives to encourage dialysis in the home.

The Order also forecasts regulatory changes for OPOs—the organizations responsible for working with hospitals to help place donor organs for transplant. The Order requires the Secretary to issue regulations and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. Additionally, the Secretary is charged to streamline and expedite the process of kidney matching and delivery to reduce the discard rate by removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers.

Additionally, the Order calls for the Secretary to consider requests for premarket approval of wearable or implantable artificial kidneys. This step is designed to encourage development and cooperation between developers and FDA, as well as produce a strategy to encourage innovation in new therapies through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology.

Finally, the Secretary shall propose a regulation to remove financial barriers to living organ donation by expanding the definition of allowable costs that can be reimbursed under the current program. Proposals would include raising the limit on the income of donors eligible for reimbursement under the program, allowing reimbursement for lost-wage expenses, and providing for reimbursement of child-care and elder-care expenses.

Sunday, July 14, 2019

Revamping Delivery of Dialysis and Organ Transplants; Sign Up to Walk for PKD; Teen with PKD Wins Pageant

Kidney Dialysis and Transplant

From NPR, by Selena Simmons-Duffin and Carmel Wroth

Trump Administration Announces Plans To Shake Up The Kidney Care Industry

The Trump administration has announced an ambitious plan to change treatment for kidney disease in the United States.

President Trump signed an executive order Wednesday directing the Department of Health and Human Services to develop policies addressing three goals: reducing the number of patients developing kidney failure, reducing how many Americans get dialysis treatment at dialysis centers and making more kidneys available for transplant.

"With today's action, we're making crucial progress on another core national priority: the fight against kidney disease," Trump said at a speech prior to signing the order.

Kidney disease is the ninth-leading cause of death in the U.S. and a major expense for the federal government. Medicare pays for end-stage renal disease treatment, including dialysis and kidney transplant.

"Taxpayers spend more on kidney disease — over $110 billion — than we do on the National Institutes of Health, the Department of Homeland Security and NASA combined," Joe Grogan, head of the White House's Domestic Policy Council told reporters.

The executive order pushes for changes in three areas: prevention, dialysis care and kidney donation. To implement parts of the order, the Centers for Medicare and Medicaid Services announced Wednesday five proposed payment models intended to increase innovation in the delivery of kidney care.

Better prevention of kidney failure is desperately needed, according to Dr. Holly Mattix-Kramer, a kidney specialist at Loyola University Chicago and the president of the National Kidney Foundation. Mattix-Kramer was among dozens of kidney specialists and patient advocates who attended the announcement Wednesday.

"We're extremely excited," she says. "For so long we felt like no one was paying attention to this epidemic of kidney disease."

One problem, she explains, is that there hasn't been financial incentive to get doctors to screen for kidney disease or to diagnose and educate patients about it. "Once you get kidney failure then there's a payment structure for that," she says. "But there lacked a good payment structure incentive for preventing kidney failure, which seems not intuitive and seems obviously something that we should fix."

The executive order proposes to change the way Medicare providers are paid to motivate them to focus on patient education and preventing the progression of kidney disease. It also calls for an awareness campaign. "Forty percent of Americans with some stage of kidney disease do not know they have it," Health and Human Services secretary Alex Azar told reporters on a call Wednesday morning.

A key focus of the executive order is effort to encourage in-home dialysis. One of the new, proposed CMS models incentivizes clinicians to offer this option to patients.

Currently, most dialysis is delivered at dialysis centers, a multibillion-dollar industry dominated by two for-profit companies. In-center dialysis can be time-consuming and burdensome for patients.

"Currently only 12% of American dialysis patients receive it at home. That would compare to 56% in Guatemala and 85% in Hong Kong," said Azar. "We want to get to 80% of those who are under treatment either in-home dialysis or transplanted eventually — so a radical change from where we stand now."

CMS Administrator Seema Verma explained that the current system prioritizes payment to in-center dialysis, but her agency wants to start to incentivize in-home dialysis and transplants.

"The way we currently pay for chronic kidney disease and kidney failure isn't working well for patients," said Verma in a statement.

Mattix-Kramer says the administration's targets for increasing the proportion of patients getting dialysis at home may be overly ambitious. "It's great to have big goals like that, but I do think 80% is going to be incredibly difficult," she says.

For a lot of her patients, it wouldn't be easy to switch to in-home treatment. "You need social support and you need a clean house and you need someplace to have equipment. Many of our patients live in areas where they don't even have a grocery store in their neighborhood," she says. "A lot of those socioeconomic issues would need to be addressed."

Another focus of the executive order is the organ transplant system. Currently, close to 100,000 people are on a waiting list for kidneys.

"Many, many people are dying while they wait," Trump said, addressing a room full of kidney doctors, advocates and patients in Washington, D.C., just before signing the executive order. "We'll do everything we can to increase the supply ... of the available kidneys and getting Americans off these waitlists."

Azar said he believes it's possible to double the number of kidneys available for transplant by 2030. "There is currently a lack of accountability and wide variability among these organ procurement organizations," he said. "The executive order will demand a much higher level of accountability." He also said living donors could receive compensation from the government for lost wages and child care.

Finally, the executive order encourages research and development of an artificial kidney, an innovation that could someday replace the need for transplants.

Administration officials touted Wednesday's news as the first major action related to kidney disease in decades. Previous administrations, including Barack Obama's, have suggested similar initiatives, but not much has changed.

Andy Slavitt, who ran the Centers for Medicare and Medicaid Services under President Obama, praised Wednesday's announcement on Twitter. "Care of kidney patients has been broken in the US for a long time, plagued with a corporate duopoly [and] a lower income minority population losing out," he wrote.

But he also pointed out that as the Trump administration makes this announcement, it is arguing in court that the Affordable Care Act should be struck down as unconstitutional. "There is one law that makes this new change possible. The same law that requires people with [preexisting] conditions get coverage. The ACA," he tweeted. "Without it, there is no authority to do this."

It was unclear how quickly these changes could roll out. Frequently, Trump's executive orders instruct agencies to develop federal rules, a lengthy bureaucratic process. One more immediate change is in how Medicare providers are reimbursed; CMS announced that its proposed payment models would roll out starting in January 2020.



Walk for PKD

From PKD Foundation

Walk for PKD 2019


Together, let’s move PKD research forward

The Walk for PKD is your chance to make a difference in the lives of hundreds of thousands in America and millions worldwide who have polycystic kidney disease (PKD).

100% of each donation funds life-saving research. Walk with us so we can bring treatments to patients faster.


Find your walk and register today.




Living with PKD

From Jacksonville.com, Florida

Jacksonville’s A. Noel Garvie crowned Miss Florida National American Teen




A. Noel Garvie of Jacksonville was crowned Miss Florida National American Teen last month during the Miss Florida National American Teen & Collegiate pageant. Noel also earned the title of overall Top Scholar.

Noel and her sister Brooks Garvie both have polycystic kidney disease (PKD), an incurable, chronic genetic disease that causes cysts to grow in the kidneys and can result in kidney failure. In spite of the painful flares and necessary medical appointments, the sisters are honor roll students and for the past two years danced as members of the Jacksonville Giants junior dance team. Noel, 16, and Brooks, 17, will both be seniors at Mandarin High School this year.

Noel wants to use her platform this year to speak to groups of girls about the importance of being authentic. She also hopes to raise awareness of PKD and host a local PKD Walk.

Noel plans to participate in the Miss National American Teen pageant in August. The competition will include an onstage question, a personal interview and fitness, fun fashion and evening wear events.

For more information on polycystic kidney disease, visit pkdcure.org. Follow Noel on Instagram @MissFLNationalAmericanTeen and with #MFLAT.

Sunday, July 7, 2019

Organ Transplants: What you need to know; Improving Dialysis Patient Care, PKD Foundation Pledges nearly $5 Million to Find Cure; Illinois Medical Marijuana: PKD Treatment

Organ Transplants

From Medical News Today, By Zawn Villines
How organ transplants work

When a person needs an organ transplant, it is because one of their organs is working very poorly or failing. Undergoing an organ transplant can lengthen a person's life and allow those with a chronic illness to live a normal lifespan.

Many people need an organ transplant due to a genetic condition such as polycystic kidney disease, cystic fibrosis, or a heart defect.

Infections such as hepatitis, physical injuries to organs, and damage due to chronic conditions such as diabetes may also cause a person to require a transplant.

Surgeons performed more than 36,000 organ transplants in 2018, but many more people need organs. In January 2019, more than 113,000 people in the United States were on organ transplant waiting lists. More than 2,000 children need organs.

The transplant process varies slightly depending on the organ, but the need for a matching donor is a consistent theme.


What to expect

In most cases, a person will die if they do not have an organ transplant. On average, 20 people die each day waiting for an organ.

In other cases, an organ transplant improves a person's quality of life, such as by removing the need for dialysis or restoring sight with a cornea transplant.


Because people who need organs typically have very serious illnesses, they may be very sick before the transplant.

The process will begin when a doctor puts a person on the organ transplant list. This requires a doctor to examine the person, diagnose a serious medical condition, and conclude that they are a suitable candidate for an organ transplant.

Organ transplantation is a complex process that requires a close match between the recipient and donor. The donor and recipient must have compatible blood types, for example.

Depending on the organ involved, other factors may also be relevant. For example, kidney donors and their recipients must have compatible antibodies and similar body sizes.

The Organ Procurement and Transplantation Network oversee the transplant waiting list. Somebody's position on the list depends on many factors, including the severity of their illness.

Once a person reaches the top of the waiting list, they will receive a transplant when the next matched donor becomes available.

When an organ is available, the person seeking a transplant must respond quickly to the call from their doctor. Surgery may occur within just a few hours of this call, as organs cannot survive for long outside of the body.

After the transplant, the organ recipient will need to stay in the hospital for a few days as doctors monitor their condition. The length of their hospital stay will depend on various factors, including how well the surgery went and the organ recipient's overall health.

Organ recipients who get sick can become severely ill. Their body may even reject the new organ, so it is important to see a doctor for any signs of infection such as a fever.

Recipients must take anti-rejection medications, as well as other types of medication, to support their long term health. These medications prevent rejection by weakening the immune system, which lowers its ability to fight infections such as the flu, so it is important for the organ recipient to avoid infections.


Statistics

Every day, more than 80 people in the U.S.receive donated organs. Many more need to. According to the U.S. Health Resources and Services Administration, 95% of people in the U.S. support organ donation, but just 58% have signed up to be donors.

A single deceased donor can save up to eight people's lives, as well as improve the lives of more than 100 people by donating tissue.

Myths around organ donation deter some people from donating their organs. The following statements are untrue:
  • Doctors work less hard to save the lives of organ donors.
  • Organ donation makes it impossible to have an open casket.
  • Most religions oppose organ donation.
  • Families may have to pay when a loved one donates an organ.


Donating an organ is free and can save or lengthen a person's life. Many people can live long and healthy lives with the help of an organ donor.

How an organ transplant will affect a person's life expectancy varies depending on their age, the organ transplanted, and the reason for the transplant.

Not all transplanted organs last forever. A kidney from a living donor lasts an average of 12–20 years, whereas a kidney from a deceased donor lasts around 8–12 years.


Finding a donor

For people who need an organ, finding a donor may take weeks, months, or longer. There are two legal ways to obtain an organ:
  • A person can wait for a donor to become available on the transplant list.
  • A person can find their own donor. This is usually a family member or friend of the person who needs a transplant, but some people are willing to donate to people they don't know. Some people even advertise for donors using social media, radio, or billboards.

There are two types of donor:
  • Living donors can donate a kidney, a lung, or a portion of the pancreas, liver, or intestines. They must be in reasonably good health.
  • Deceased donors can donate two kidneys, two lungs, the heart, pancreas, corneas, and intestines. They may also donate body tissue, such as heart valves, tendons, or skin. Hand and face donation became an option in 2014.

It is illegal to buy or sell organs. However, a 2013 study claims that paying living donors $10,000 for kidneys could increase the rate of organ transplants and save many more lives.

Some nations, including Iran, allow paid organ donation. Sometimes, the system allows wealthy donors to pay much more for organs. This means that people in dire financial situations may be more likely to donate organs, raising concerns that they may sacrifice their health for financial gain.


Benefits

The benefits of an organ transplant depend on the organ a person receives. Some benefits may include:
  • avoiding medical procedures such as dialysis
  • living a longer life
  • living a healthier or less painful life
  • gaining an improved quality of life, such as when a cornea transplant restores a person's sight
  • correcting congenital disabilities that endanger a person's life
  • spending less time in the hospital, needing fewer surgeries, or taking fewer medications

Risks

For almost all organ transplant recipients, the benefits far outweigh the risks.

Most people who need an organ will die or live a much shorter life without a transplant. However, organ transplants are risky surgeries, especially since those who need them often are very ill.

Some risks associated with organ transplant surgery include:
  • complications related to the use of anesthesia, including death
  • bleeding or other complications during the procedure
  • postsurgical complications, such as infection
  • a higher risk of infections and other illnesses due to anti-rejection or other transplant-related drugs
  • organ rejection
  • organ failure

Outlook

The outlook for a recipient depends on the organ they receive, the reason for the transplant, their age, their overall health, and other factors.

Some people may need another organ transplant. A very young kidney recipient, for example, might outlive their organ. Others may live long lives without the need for another organ.

Most people, however, will need ongoing medical care, and they must continue to take anti-rejection drugs.

It is vital to discuss the risks and benefits of organ transplantation with a doctor. Because lifestyle directly affects organ health, including that of transplanted organs, organ recipients should talk with their doctor to get advice on how to lengthen their lives and protect their organs.




From Harvard Business Review, by Yvelynne P. KellyDiane GoodwinLisa Wichmann
Mallika L. Mendu

Breaking Down Health Care Silos

A patient we’ll call Bonnie has been on dialysis for five years, making the difficult trip three times a week to a clinic to sit for hours hooked up to a machine that filters toxins from her blood. Bonnie is 65 and suffers from end-stage renal disease (ESRD), the gradual failure of her kidneys. She has chronically low blood pressure, which complicates the dialysis, and ingests a lot of salt which causes weight gain between treatments. Often, she wakes up breathless and ends up in the emergency department. The ED and dialysis unit don’t have a shared electronic health record, and on discharge there is little communication between the two sites about her care. Nor is there communication between the dialysis unit and her primary care doctor (PCP). When she’s hospitalized, her medications are sometimes changed, but that critical information often doesn’t get back to her many providers. Bonnie is hoping for a kidney transplant, but she doesn’t know where to start, and she has yet to undergo an evaluation to see if she’s eligible.

This type of siloed, uncoordinated ESRD care has serious consequences for Bonnie and thousands of patients like her. On a national level, ESRD takes a huge toll on patients, families and caregivers, and society. Transplants are exceedingly scarce, and so for the vast majority of the 750,000 people affected by ESRD in the US each year, dialysis is the only viable treatment. For patients on dialysis, hospitalization rates and risk of developing related medical problems, and of dying, are high. Finally, while ESRD patients make up less than 1% of the Medicare population, they account for more than 7% of the Medicare budget – a staggering $50 billion annually.

Fragmented care is an important part of the reason for the high costs and utilization and often poor outcomes associated with ESRD. Patients receive care through a patchwork of providers at various sites — outpatient dialysis units, primary care practices, specialty clinics, hospitals and others – which often don’t communicate. Gaps in care are inevitable, and opportunities to intervene before problems arise are often missed.

That’s why in 2016 we launched a coordinated ESRD program within Partners Healthcare, based at Brigham and Women’s Hospital (BWH) in Boston, one of the first to bring the care-coordination principles that are increasingly common in primary care to disease-specific specialty care. While other programs, like the CMS ESRD demonstration projects, have piloted care-coordination models with large dialysis organizations, ours is the only such program that we’re aware of that coordinates care across all stakeholders (dialysis units, hospitals, primary care providers, and others) rather than focusing on care within the dialysis unit itself. Further, unlike other programs, ours extends beyond dialysis-based care to facilitate transplant evaluations and, when needed, palliative care.

At the start of the program, a nurse care coordinator (co-author Diane Goodwin) connected with Brigham and Women’s ESRD patients weekly at four dialysis units, identifying those at risk for deterioration and increased utilization (ED visits and hospitalizations) and implementing strategies to reduce utilization and improve clinical outcomes. These included face-to-face visits to provide self-care education and guidance on avoiding the ED, medication reviews, dialysis-treatment monitoring, tracking immunizations, assuring reliable vascular access, and working with the dialysis unit, visiting nurses, PCPs, specialists and others to coordinate care and assure that all involved had the same information about the patient’s history and status. (Today we have three nurses in this care-coordination role.)

For patients who are admitted to the hospital, a nurse within the program conducts a post-discharge assessment which includes documenting all medications the patient is on, and the dosage, frequency and route, and communicating this and other key information to the patient’s PCPs, the dialysis unit, and others. When patients do go to the ED, a nurse likewise reaches out to the ED team to share information, help guide care and ensure appropriate follow up. Finally, program nurses communicate directly with transplant coordinators to facilitate evaluations and assure that eligible patients are placed on transplant wait lists.

To date, the program has engaged with a total of 100 patients and is currently coordinating care for 54. The results three years out are encouraging. Among these high-risk patients (those who among other indicators have missed treatments, required transfusions, or habitually used the ED for non-urgent issues) we’ve seen on average 5 fewer ED visits or hospital admissions per patient per year than would have been typical before our intervention. Close to one-fifth of the patients in the program have been referred to palliative care, and several who otherwise wouldn’t have received transplants have had them as a result of the program’s enrollment efforts.

By reducing healthcare utilization and facilitating transplantation we’ve thus far saved twice the amount that it costs to run the program. In one slice of the data, we calculated $428,000 in savings from 74 avoided ED visits and 34 avoided admissions, and over $1 million in savings attributable to facilitated transplantations. Feedback from patients and providers has been overwhelmingly positive. In an email, one nephrologist praised the program as a “GREAT addition to ESRD patient care,” citing “improved communication, improved integration of care between providers, [and] avoiding admissions.”

Going forward, we’ll be evaluating the impact of the program on costs and utilization relative to those of a matched control group, and are expanding this work to other Partners hospitals and outpatient dialysis units. Ultimately, as we establish the positive impact of the program and the ability to translate it to other settings within Partners, we hope to disseminate it to other institutions. The goal is a future where silos are broken down in ESRD care delivery and patients, providers, and society share in the benefits.



From WLS-TV, ABC Affiliate, Chicago, By Sara Tenenbaum

Illinois medical marijuana: New qualifying conditions added as program becomes permanent

The list of qualifying conditions for medical marijuana in the state of Illinois has expanded after the General Assembly passed SB 2023, which also makes the state's medical cannabis program permanent.

The bill, sponsored by Rep. Bob Morgan (D-Highwood), operates independently of HB 1438, which legalized recreational marijuana in Illinois.

Morgan, who was also the architect of the Medical Marijuana Pilot Program, said the bill is meant to stabilize and make permanent the medical cannabis program in Illinois. By keeping the program separate from recreational marijuana, it ensures that any future legislative changes to the recreational law do not affect medical patients, including in the case that the recreational marijuana law is ever repealed.

The bill was sent to Governor JB Pritzker to sign on June 12. Morgan said they're still working to set a firm date, he expects Pritzker will sign SB 2023 sometime in the next month.

The Medical Marijuana Pilot program was approved in 2013, began sales in 2015, and was expanded by then-governor Bruce Rauner in 2018. It is considered one of the most restrictive medical programs in the country and was set to expire in July 2020 until SB 2023 passed.

Along with adding new conditions, SB 2023 gives veterans access to medical marijuana through the Opioid Alternative Pilot Program. The 11 new qualifying conditions for medical marijuana patients are: autism, chronic pain, irritable bowel syndrome, migraines, osteoarthritis, anorexia nervosa, Ehler-Danlos Syndrome, Neuro-Behcet's Autoimmune Disease, neuropathy, polycystic kidney disease and superior canal dehiscence syndrome.

The new conditions will be eligible as soon as the Illinois Department of Public Health writes and publishes new rules. A spokesperson for the IDPH's Division of Medical Cannabis said there is currently no set timeline to write and publish the new rules, though they are working to get them drafted as quickly as possible.

Rep. Morgan said the rule writing and publishing process typically takes about 90 days and is comprised of a period of public comment and then legislative review.

There are 55 medical marijuana dispensaries currently operating in Illinois, and more licenses are expected to be issued in 2020. Medical marijuana patients are also the only people who can cultivate marijuana plants at home under the recreational law. Patients will be able to grow up to five plants, which Morgan said most benefits rural patients who live far away from dispensaries. He said that medical patients will also have first-in-line access to marijuana and marijuana products in case of a supply shortage after recreational use begins next year.

For more information on medical marijuana in Illinois and how to get patient card if you have a qualifying condition, click here.





From Healio

PKD Foundation pledges nearly $5 million toward research for a cure


Over the next 2 years, the PKD Foundation will invest almost $5 million into studies focused on treating and curing polycystic kidney disease, according to a press release.

“For the past 36 years, our goal has been to support PKD patients from care to cure. With the support of generous donations, we have the ability to stand beside PKD patients until there is a cure, supporting research for new treatments and to support researchers,” Andy Betts, CEO of the PKD Foundation, said in the release

Growing interest from the PKD research community has enabled the foundation to increase funding and award grants and fellowships yearly, rather than biannually, for the first time since 2009.

In 2019, the foundation funds more than 30 researchers, the largest number of awards given in a single year in the foundation’s history.

The PKD Foundation has awarded nearly $50 million to grants, fellowships, awards and scientific meetings since its establishment in 1982.