An Executive Order.

Yup.  TheDonald issued another one on the 10^th of July; this one will change the way dialysis and transplants happen in America.

 

 

 

 

 

 

The goal is to increase the number of transplants that are done each year.  (Kidney matching processes will be “streamlined’.)  And, for dialysis- to let patients dialyze at home.  And, to opt for earlier intervention with those patients who may need dialysis.

Don’t forget- dialysis is big business! Medicare shells out some $ 110 billion a year for ESRD (end state renal disease); given that Medicare spends  $ 700 billion  a year, this means 15 cents of every dollar Medicare spends goes to treat ESRD patients!  (Since 1973, HHS and Medicare has covered the cost of dialysis, initially after a 9 month transition, now up to 18 months.)

By the way- to put that $ 110 billion in perspective…  That is more than we spend for NASA, NIH (National Institutes of Health), and DHS (Department of Homeland Security)- combined!!!!!

One big issue is that, as is true for the rest of our health care system, we have no mechanisms in place to prevent system failure.  We don’t prevent disease (except for vaccinations- which too many Yahoos refuse).  Instead, we set up elaborate (and expensive) systems to treat the problem- after it is a major issue.

Until this executive order (one is hoping it has a large follow-through), there have been  no financial incentives for doctors to screen for kidney disease, to diagnose potential CKD [chronic kidney disease] patients, or even to educate existing patients.  (Think of all the diabetes patients who are a short step away from kidney failure.)  Instead, we spend 1/7 of our Medicare budget to treat kidney failure.

Of that $ 110 billion, 1/3 is specifically for dialysis (about $ 40 billion).  And, that’s an annual cost.  For about the same one year payment to a dialysis center for one patient, a kidney could be transplanted- which would provide significant savings to the system.

Home Dialysis

You may not know this, but back when Bicarbolyte (my firm that invented liquid bicarbonate dialysate- no mixing, no microbial infections, better patient physiology) started operations in 1984, home dialysis was coming back into vogue.  Home Intensive Care (HIC) provided a technician (and the occasional nurse), a fully functional state-of-the-art dialysate delivery device, a water treatment system, a dialyzer- in other words, everything that was needed to provide a quality in-home treatment.  (I should note that HIC was our second largest customer.)

But, Health and Human Services (HHS), the agency that runs Medicare, did not like the HIC model. HIC was billing the agency roughly $ 35K a year for treatment, just  like Fresenius and DaVita did.  (Actually, it was both of their predecessors, but the concept is the same.  HHS claimed they only paid about $ 20K a year for dialysis at the time.)

What was wrong?  HHS didn’t feel that HIC was entitled to get those fees.  They thought home dialysis should be paid at a lower rate.  After all, they didn’t have a doctor show up at each home.  (Keep in mind that while a dialysis center may have a doctor in the unit, there are 20, 40, even 75 patients undergoing treatment.  With maybe two or three techs and four to eight nurses.  That’s far less per patient that the one-on-one HIC provided.)   And, that was despite the fact that patients treated via HIC’s process were far less likely to show up in a hospital for a few days, because their treatment was more attentive.

Eventually HHS and HIC met in Federal Courts (in DC), with Judge Sporkin presiding.   And, HHS prevailed- and HIC was promptly subsumed by Fresenius- with large-scale home dialysis therapy disappearing just as promptly.

Right now only about 1 in 8 patients are dialyzing at home- and most  o f those are treated via peritoneal dialysis.  But, there has been a push of late to effect more home dialysis.  Not just to save money, but to make it less traumatic for the patient (assuming they have a willing partner at home to help with the treatment) – there is no need to be transported thrice weekly to a clinic, where the patients sit for four hours (and are there for closer to 5.2 h) undergoing treatment.

The executive order will allow for five (5) new payment models that are supposed to encourage earlier intervention- before kidneys fail- to prevent the need for dialysis.  It’s hoped that doctors will rise to the challenge.

NOTE 1 :  One of the payment models will consider nursing homes to be ‘home dialysis’ locations.  Which means a tremendous financial benefit for that business segment, but the data has shown that such dialysis is typically below par.  And, there are only 8,000 dialysis patients in nursing homes, so this is not a large segment of the population, either.   But with financial incentives, you can bet it will grow.

NOTE 2:  Another payment model will provide incentives to physicians to move patients to home dialysis.  Their performance will be monitored year to year; if they meet the ‘standard’, their incentive will be 3% more compensation in year 1, 2% in year 2, and 1% in year 3.

The payment choices (ESRD Treatment Choices Model [ETC]) will be published on Thursday (18 July), with a 60 day comment period.  It is expected that the ESRD Prospective Payment Schedule (PPS) for dialysis centers and the Medicare Physician Fee Schedule (PFS) for nephrologists would go into effect on 1 January 2010,  ending on 30 June 2026.

Transplantation

When it comes to transplants, part of the problem is that not enough  organs are donated.  About 113,000 folks are desperately waiting for an organ donor (about 100K just for kidneys).  But, besides the lack of donors, the cacophony of 58 non-profits around the US that collect organs for transplant prevails.  Each organ procurement organization (OPO) controls a territory (a monopoly, as you can see), controlling the data and the reporting of “successful” transplants.  (Yes, not surprisingly, some OPO’s manipulate the data to squeak by increased regulation.) By improving their coordination, it’s hoped that 17,000 more kidneys and 11,000 other organs (hearts, livers, lungs) will be transplanted each year.

The goal is to open up those territories, move organs around the US, speeding the delivery of the transplants.  Not only will more folks be able to get transplants, organs won’t be allowed to decay as they wait for the ‘perfect’ recipient- and then get discarded because they aren’t up to the standard of the surgeon (who wants his/her statistics to be perfect).

WooHoo!  Not only is there a program to create new therapies (as I reported here), but now there are better incentive to encourage home dialysis and earlier interventions.