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Shuvo Roy, at the University of California, San Francisco (UCSF) has assembled a multi-disciplinary team from across the US to develop an implantable artificial kidney. The device—about the size of a large coffee mug—would out-perform today’s dialysis machines that are roughly the size of a refrigerator.

Sandy Kleffman, writing for the San Jose Mercury News, reports that the US Food and Drug Administration (FDA) as selected the device for its Innovation Pathway fast-track approval process. As such, animal testing could begin in 2016 with human trials beginning as early as 2017, and use as a routine therapy as early as 2020. “We realized we could achieve a dialysis filter that would be one-twentieth the size of what’s commercially available, and would require so little power that we could drive it just off blood pressure alone,” Roy, a UCSF associate professor of bioengineering and therapeutic sciences tells Kleffman. The tiny dialysis filter is assembled using silicon nanotechnology.

According to Kleffman’s interpretation, Roy’s device would be better than traditional hemodialysis, as “blood brought into one side of the device passes through a silicon filter that removes toxins, sugars, salts and water, creating an ‘ultrafiltrate.’ The filtrate would move to the other side of the device, where actual kidney cells would reabsorb the water, sugars and salts back into the bloodstream, mimicking a real kidney’s metabolic and water-balancing roles in a way that dialysis cannot. The team obtains the kidney cells from organs rejected for transplantation.”

Roy’s assumption is that immuno-suppressant drug therapy would not be needed because the kidney cells contained within the device would be separated from the patient’s bloodstream, making rejection much less likely.

Massachusetts General Hospital researchers have created functioning rat kidneys in vats capable of filtering waste and producing urine, even after transplantation. The kidneys were created by stripping all of the cellular material from donor rat kidneys leaving a scaffold-like structure called the extracellular matrix, comprised mostly of collagen. The extracellular matrix also contains blood vessels and connective tissue. New cells—including stem cells from young rats—were then added to the extracellular matrix. Within weeks, the new cells differentiated into the organ’s complex system. Because the extracellular matrix retains the physical shape of the donor kidney, transplantation of the organ is less complicated.

Harald C. Ott was the primary researcher and lead author of the team’s research published in Nature Medicine. Henry Fountain, writing for the New York Times, reports that Ott “developed the technology of stripping organs of their cells, called decellularization, while at the University of Minnesota. The process uses a detergent to wash away the living tissue, leaving a network of proteins that retains the structure of the blood vessels and other components of the organ.”

Ott’s decellularization process sounds identical to the one developed by Doris A. Taylor in 2008 to grow rat hearts in vats, while Taylor was also at the University of Minnesota. At that time, Ott was one of Taylor’s research associates. In 2010, the University of Minnesota announced it had entered into an exclusive, global license with Taylor’s company, Micromatrix Medical, Inc. A few months later, Minnesota’s Agricultural and Economic Development Board loaned US$250,000 to Taylor’s startup (second item), with the intent of keeping the business in the state. In 2011, the University of Minnesota removed Taylor from the board of directors of the company she founded. That’s a story that warrants further investigation.

Other researchers report clotting to be a common problem in working with decellularized tissue when a regenerated organ is transplanted. Ott’s group saw no such clotting although Fountain reports the experiments were terminated before the kidneys stopped functioning. Surprisingly, we don’t know why the experiments were stopped short. It makes no sense—wouldn’t you want to know how long the kidneys functioned?

With regard to using the technique in humans, Ott told Fountain, “You’d take a kidney matrix off the shelf. Then in an ideal world, you’d take cells from that patient and create a kidney on demand.”

The US Centers for Medicare & Medicaid Services (CMS) has proposed two new quality measures (.zip/.pdf; 15MB) for its 2016 end-stage renal disease (ESRD) quality incentive program (QIP):

1. Measurement of hospital readmissions within 30 days
2. Restoration of “floor” to hemoglobin measurement

In its 2012 ESRD QIP, CMS removed a measure requiring dialysis clinics to report low levels of hemoglobin in patients, requiring only the reporting of those patients’ with hemoglobin levels above 12 g/dL. The proposal for 2016 would restore the requirement for reporting patient hemoglobin levels below 10 g/dL.

CMS reports it is considering restoring the “floor” hemoglobin level measurement requirements “because there are concerns that [the removal of the “floor” hemoglobin metric] could result in underutilization of [erythropoietin stimulating agents] ESAs, with lower achieved hemoglobin values that may impact quality of life or increase the frequency of red blood cell transfusion in the US chronic dialysis population.”

Additionally, the anemia management section of the draft requires:

1. Measurement of patient informed consent for ESA treatment
2. Measurement of ESA treatment to avoid transfusion
3. Measurement of standardized transfusion ratio
4. Continued measurement of patient hemoglobin levels above 12 g/dL

Both of these quality measures are great steps in the right direction and will hopefully be incorporated into the 2016 ESRD QIP.

On 26 March, Minnesota Attorney General Lori Swanson telegraphed her concerns about a merger currently under consideration between Fairview Health Services—the second largest healthcare system in the Twin Cities—and South Dakota-based Sanford Health—one of the US’s largest rural healthcare providers. That the University of Minnesota’s Medical Center—the region’s primary research and teaching hospital—would likely be part of any merger only served to make the situation more worrysome.

Fairview is a Minnesota charitable trust that has grown to prominence largely through its tax-exempt status. As such, it has significant obligations to taxpayers and donors that cannot be vaporized with a corporate merger. Charitable trusts in Minnesota are regulated by the state’s attorney general.

“I am troubled by the notion that a small group of people at Fairview and Sanford would conduct private discussions without the benefit of the public’s input regarding a matter of such sweeping consequences for Minnesota,” Swanson told Tony Kennedy and Jeremy Olson, writing for the Star Tribune, in disclosing the negotiations. Kennedy and Olson report that Fairview’s board is scheduled to meet 8 April, presumably on the issue. Swanson has announced a public hearing for 7 April.

In a follow-up article, Jackie Crosby reports for the Star Tribune that Sanford Health had been negotiating with Allina Health—the largest healthcare system in the Twin Cities—for more than a year until that deal fell apart last year. Her source was Sanford Health President and Chief Executive Kelby Krabbenhoft. Sanford Health’s negotiations with Fairview began last fall.

Kennedy and Olson report that while Swanson has not yet filed suit against the merger, she put Fairview on notice with a letter in which she wrote “the assets that Fairview has accumulated over the years with public and private support should not be allowed to benefit Sanford’s expansion or other private business plans.” Swanson also noted that “a significant portion of Fairview’s assets are ‘restricted to being utilized for health-related activities for the benefit of Minnesota patients.’”

University of Minnesota General Counsel Mark Rotenberg told Kennedy and Olson that the University’s concerns focused around support for research and clinical training. Also of concern were governance of University physicians and how they manage medical facilities on the campus. The University transferred operational control of its medical facilities to Fairview in 1997.

Medicare (and its sister Medicaid) seems to be the only healthcare system in the US that works. As Kip Sullivan’s most recent research concludes, Medicare allocates 1.4 percent of its total spending to overhead costs. Medicare Advantage—the privatized alternative to traditional Medicare—benefits by leveraging Medicare’s price negotiations but still spends six percent on administrative overhead.

The largest traditional health insurers with the most leverage negotiate prices that are 30 percent to 50 percent higher than those paid by Medicare, negotiating up from the Medicare price rather than down from the chargemaster price, according to Steven Brill’s “Bitter Pill: Why Medical Bills Are Killing Us” for Time. As consolidation continues among healthcare providers, this situation is reversing: Negotiations are moving more and more to large hospital chains insisting that insurers negotiate up from the chargemaster price, rather than down from the Medicare price. And the administrative overhead costs of traditional health insurers is much, much higher than Medicare: “... From about 7 percent for employment-based plans with 1,000 or more enrollees to nearly 30 percent for policies purchased by very small firms (those with fewer than 25 employees) and by individuals,” according to 2009 testimony by the Congressional Budget Office (.pdf; 199KB) (CBO) to the US Senate’s Budget Committee.

If that’s not enough to convince you that the best solution to the US’s absolutely broken healthcare system is a single-payer system based on Medicare for all as a baseline starting point, consider that my home state—Minnesota—seems incapable of verifying recipients enrolled in its taxpayer-subsidized health insurance system. The program, MinnesotaCare, admirably serves those individuals in the state who can’t afford private health insurance but have too much income to qualify for Medicaid. MinnesotaCare, one of the last great bastions of the state’s late lamented progressive past, meets the needs of a great many Minnesotans who would otherwise fall through the cracks.

Brad Schrade, writing for the Star Tribune, reports the Minnesota Department of Human Services (DHS) has for 10 years failed to verify the incomes of MinnesotaCare enrollees. Schrade cites a report by Jim Nobles, the legislative auditor.

DHS spent US$40 million to develop a web-based system to address the problem only to see it fail completely and apparently spectacularly. In fine bureaucratic fashion worth of a Monty Python sketch, Schrade cites Human Services Commissioner Lucinda Jesson as agreeing with the legislative auditor’s findings, taking the issues “very seriously,” and asserting her agency “will work diligently to correct them.” Jesson points to “a new IT system to meet requirements of the federal Affordable Care Act that will include income verification.”

By magic, one supposes. Just like the last one; only better.

Why not just bag it and extend the Medicare system to the entire citizenry? It’s already got an incredibly efficient administrative system in place that’s entirely capable of factoring premium price based on income.