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