Kidney disease executive order

The White House is expected to release a new executive order on chronic kidney disease treatment priorities, rules and payment experiments this afternoon.  This is outside of my area of expertise, but so far, the pre-reporting indicates that this looks to be both a big deal and good news.

I will let Dylan Matthews at Vox explain more:

 

The order has three major parts: one on living kidney donors, one on deceased donors, and one on alternatives to center-based dialysis.

The executive order attempts to reform the system for living kidney donors (like me), as well as living liver, lung, and intestine donors, by making sure donors are held financially harmless for donating…

The second aspect of the executive order targets deceased donation. In the US, there are 58 agencies with local monopolies over the provision of dead people’s organs, known as organ procurement organizations (OPOs). For some time now, independent analysts and investigative reporters have argued that OPOs are underusing deceased donor organs by the tens of thousands….

executive order scraps the existing evaluation system in favor of two simple, harder-to-game criteria….

the Affordable Care Act, in one of its lesser-known, cost-focused provisions, set up the Center for Medicare and Medicaid Innovation, which has the authority to pursue cost-saving treatments that improve quality of care. The executive order instructs the centers to experiment with new approaches to provider payment — like rewarding nephrologists for directing their patients toward transplants, and for preventing patients from progressing to kidney failure for as long as possible

Transplants are the big deal conditional on individuals advancing to end stage renal disease(ESRD). Transplants in the out years are cheaper than end stage renal disease dialysis while managing the chronic kidney disease (CKD) progression is far cheaper than end stage and transplants as shown in the 2020 ACA Adult Silver risk adjustment co-efficiencts for HCC 183, 184, 187, 188.

HCCDiseaseSilver 2020 Adult Co-efficient
HCC 187CKD Stage 40.985
HCC 188CKD Stage 50.985
HCC 183Kidney Transplant Status6.035
HCC 184ESRD24.75

Beyond the simple fact that a transplant in the out-years is cheaper, it often is a much higher quality and quantity of life than ESRD with dialysis. People with successful transplants aren’t tied to an exhausting local dialysis center with limited opportunities for travel or work.

The ideal payment models should be set up to make managing CKD at lower levels of severity to be more profitable for risk bearing entities than moving these individuals to first transplant and then long term center-based dialysis.  Ideally, dialysis centers are merely a short term bridge to a transplant instead of a common long term quasi-solution.

The Center for Medicare and Medicaid Innovation (CMMI) is one of the core elements of this executive order.  CMMI can come up with payment models that bypass Congress to see if a new way of paying for care improves quality and/or lowers cost for a constant level of quality.  If the model shows actuarially sound value improvements in pilot projects, then CMMI can take the model national.  The kicker is that CMMI is a creature of the ACA which seems to be under threat in the courts again.  Without the ACA, the entire payment reform part of the executive order falls apart.

 






56 replies
  1. 1
    rikyrah says:

    The kicker is that CMMI is a creature of the ACA which seems to be under threat in the courts again. Without the ACA, the entire payment reform part of the executive order falls apart.

    Hmmph

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  2. 2
    rikyrah says:

    OT: I know that I’ve asked before, but, so you know anyone that could write a post about why insulin doubled in price over the course of 4 years? I smell greed and collusion.
    I’m so disturbed by the stories that I read about desperate insulin-dependent diabetics and what they’re going through.

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  3. 3
    Ohio Mom says:

    This is so out of character for the Trump administration that I am wondering what the catch is.

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  4. 4

    @rikyrah: I don’t have the knowledge to speak intelligently on this.

    @Ohio Mom: Personal experience of quite a few people in power.

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  5. 5
    Baud says:

    @Ohio Mom:

    Perhaps there’s a catch. But, frankly, although Trump is given it the old college try, it is difficult for any administration to completely avoid doing a single positive thing over four years. Maybe this is Trump’s.

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  6. 6
    rikyrah says:

    @Ohio Mom:

    This is so out of character for the Trump administration that I am wondering what the catch is.

    Someone has a company that will make money from it…we just have to wait for it to be revealed.

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  7. 7
    chopper says:

    given rising temperatures due to climate change and the associated dehydration that comes with it, outdoor laborers are going to be seeing rising rates of chronic kidney disease in the future. might as well start doing something now:

    In the sugarcane region of El Salvador, as much as one-fifth of the population has chronic kidney disease, including over a quarter of the men, the presumed result of dehydration from working the fields they were able to comfortably harvest as recently as two decades ago. With dialysis, which is expensive, those with kidney failure can expect to live five years; without it, life expectancy is in the weeks. Of course, heat stress promises to pummel us in places other than our kidneys, too. As I type that sentence, in the California desert in mid-June, it is 121 degrees outside my door. It is not a record high.

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  8. 8
    Another Scott says:

    Warning Politico:

    Administration officials are still working to finalize details ahead of Wednesday, although senior officials have repeatedly hinted at the strategy.

    […]

    The closely guarded plan has the potential to upend how kidney care is delivered. U.S. dialysis centers reported about $24 billion in revenue last year, mostly at clinics owned by DaVita and Fresenius. Medicare also spends more than $114 billion on kidney care per year, according to the most recent government figures— $79 billion to cover people with chronic kidney disease and another $35 billion on end-stage renal disease.

    “Two companies effectively control the market and neither currently are financially incentivized to change behavior,” said Chris Meekins, a Raymond James analyst and former HHS official. “The administration needs to put forward enough carrots to encourage new market entrants and enough sticks to force the current players to alter behavior if real change is to occur.”

    The effort is also personal for top administration officials, who have touted their family stories in public speeches and private meetings.

    […]

    Kidney disease is a significant driver of Medicare spending, and the new initiative comes as the administration and Congress have made lowering health care costs a top priority, seeking an issue that can be touted on the campaign trail. And the Trump administration, under Azar, has a renewed focus on using the CMS Innovation Center to accomplish this goal and attempt to transition the health care system to paying for value instead of volume of services.

    […]

    Emphasis added. The bolded parts give me pause (if it’s a huge market and will be opened up, why do new players need ‘incentives’?). If Azar is doing a good job, then I expect him to leave within the next 6 months.

    :-/

    Me, cynical? Naaah…

    “Follow the money!” – Deep Throat A. Silverman.

    Seriously, the devil’s in the details – especially with Donnie’s minions.

    FWIW.

    Cheers,
    Scott.

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  9. 9
    Keith P. says:

    I’ve been on dialysis for 9 years now, so I’m actually interested in what Trump is going to do here.

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  10. 10
    Ohio Mom says:

    @David Anderson: I’ve always wondered if it wasn’t the personal experience of people in power that led to the socialization of kidney dialysis.

    The explanation that dialysis is too expensive for private insurance to cover so the government took over left me wondering about all the other conditions that cost big bucks.

    Of course one way the insurance companies got around those other expensive conditions was lifetime caps, and there is the safety net of Medicaid.

    But why is dialysis is a category of its own, and not so many other chronic, life threatening conditions? Diabetes and insulin (as rikyah mentions) for one, or very involved disability (those people are in constant battle for what they need).

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  11. 11
    Barbara says:

    @Ohio Mom: I have made this point before, but there seem to be two kinds of people inhabiting appointed positions in the Trump administration — the first are people like John Bolton, who has his own agenda and sees Trump as an ideological vacuum that presents an ideal opportunity for grabbing power to do what he wants, and some are people who have worked in various industries that are regulated by the agency who are there at the behest of companies or trade groups that would like to avoid chaos as a result of a regulator’s ignorance. Which is another way of saying that there are actually some very smart and capable people who are working at HHS, even in appointment level positions.

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  12. 12
    Barbara says:

    @Ohio Mom: Coverage of dialysis under Medicare is an anomaly that goes back to political pressure from families and doctors at the time dialysis first became prevalent.

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  13. 13
    Ohio Mom says:

    @Keith P.: Congrats on nine years — it’s a lot of work being on dialysis successfully.

    We’ll be interested in your reports after these new policies are finalized and implemented on how they are affecting patients. Though I realize that is going to be a while.

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  14. 14
    Gin & Tonic says:

    @David Anderson:

    I don’t have the knowledge to speak intelligently on this.

    A sentence rarely posted in comments here.

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  15. 15
    narya says:

    My mom managed her failing kidneys (completely idiopathic, as far as anyone could tell) for two years by managing her diet, but eventually had to go the route of dialysis, 2 (I think) days/week. Then, 9.5 years ago, she got a transplant, and it was a fking miracle, not least because she was in her 70s when she got it. The way it completely returned her quality of life is just awesome–and I wish the same for everyone in her situation.

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  16. 16
    Ohio Mom says:

    @Barbara: Yes, that is what I’ve heard. There are lots of people representing other serious medical conditions that lobby however that haven’t had such good success.

    I am happy for dialysis patients, I’d like every other type of patient with serious conditions to have the coverage. You’d think the insulin-dependent community has a good case but I’m not seeing much movement to help them.

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  17. 17

    @Baud:

    it is difficult for any administration to completely avoid doing a single positive thing over four years. Maybe this is Trump’s.

    Trump does not read. He sure as Hell does not read the kind of complicated documents that make up most executive orders. Someone slipped this into a pile of orders for deregulation and torturing brown people, and he signed it in total ignorance. Just another day in the Court of the Sun King.

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  18. 18
    Barbara says:

    @Ohio Mom: Once it became obvious that dialysis was just the dawn of a new day of expensive medical technologies Congress declined to extend coverage on a piecemeal basis. It is worth remembering that the Nixon administration tried to pass a universal coverage scheme similar to Medicare and that Teddy Kennedy, to his ultimate and enduring regret, blocked it because he deemed it insufficiently comprehensive. So Congress realized, sensibly, that extending coverage piecemeal on the strength of competitive lobbying was wrong but was unable to do something more comprehensive, regardless of a person’s disease status. Also remember that while coverage of dialysis is surely a lifeline for many people, Medicare coverage for CKD stops once a person receives a transplant.

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  19. 19
    randy khan says:

    What I am most curious about is why this is an Executive Order. It seems like something that should come out of HHS. I mean, it’s okay either way if it benefits people, but I don’t recall Obama or Clinton or the Bushes doing this sort of thing. (And maybe I’m wrong about that – I wasn’t reading blogs that covered health care policy back in the day.)

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  20. 20
    Van Buren says:

    @Ohio Mom: Somebody he cares about needs a transplant.

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  21. 21
    Barbara says:

    @randy khan: CMMI was enacted via the ACA. Obama used CMMI for a number of initiatives, the most notable being reimbursement associated with joint replacement surgery, which is the most common surgical procedure received by Medicare beneficiaries. It was controversial and various initiatives have been challenged when they were not “voluntary.” I don’t know why there needs to be an executive order for this one, but these executive orders are incredibly vulnerable to challenge on the basis of no statutory authority. I will be looking at it as soon as I get my hands on it.

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  22. 22
    Barbara says:

    @Van Buren: You lose Medicare coverage on the basis of ESRD within two years of receiving a transplant.

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  23. 23
    Mike in NC says:

    Fat Bastard just loves to issue Executive Orders while enjoying hours and hours of Executive Time. Doesn’t matter if they’re legal or even make sense. Next Executive Order will require beachgoers to wear sunscreen and keep their dogs on a leash. The God-Emperor has issued his edict!

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  24. 24
    jl says:

    @rikyrah: I don’t have time right now, but I do know there are some reports on the issue. I’ll go find them later today or tomorrow and will link to them here. I think the consensus of health economists and clinicians who have looked into it is that it is a mix of greed and collusion and using price discrimination to suck as much economic value out of society in return for the insulin. The average price of insulin to large corporate providers has not been nearly as large as the increase in the list prices quoted in the news stories. So, if you have good insurance, a good, large, provider with buying power and the right connections and which decides that it wants or needs to serve the needs of its diabetic population, then the insulin can be obtained at a reasonable cost. If not, the the insulin cannot be obtained at a reasonable price and you have no recourse except. The US patent system, which is internationally and historically extremely generous to corporate profits, plays a role. Bundling of pen and other delivery systems and the active drug under patent is allowed in the US that promotes ability to charge extremely high prices and keep newer insulin type products (the active drug itself) under eternal patent protection is allowed in the US in way that it is not in other comparable countries.

    So, it is a horrible story of a horribly dysfunctional health care system. The problem is an infernal mix of several issues.
    I’ll alert you when I find the links.

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  25. 25
    randy khan says:

    Can we haz ticker tape parade post?

    (I figure it’s not OT because you never know when “ask the referee” will pop up on a David Anderson post.)

    ReplyReply
  26. 26
    jl says:

    @Van Buren: It is also possible that Azar, HHS secretary, is one of the two or three half-way decent officials who were slipped by Trump, or who have gone rogue and decided to half-way do their jobs. But that is just a guess. We’ll see if there are dirty tricks in some of the good plans Azar has put forward. But he hasn’t had much success. His plan to force drug companies to reveal drug prices in their advertising was just shot down in a federal court.

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  27. 27
    kindness says:

    Except I don’t trust anyone from the Trump administration to enact a policy where they don’t play favorites because that is the entirety of what they do. Right now here in California at least there is a known path for obtaining a transplant and moving up the list. From what I had read about earlier, this directive will toss that list overboard. I see lots and lots of lawsuits with this change. Sorry.

    @Ohio Mom: Even with a contract the company I work for pays about $50K a month for each dialysis patient. It isn’t cheap. It’s a big National company too.

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  28. 28
    Betty Cracker says:

    Are we sure it’s not really for boob jobs?

    ReplyReply
  29. 29
    rikyrah says:

    @kindness:

    Except I don’t trust anyone from the Trump administration to enact a policy where they don’t play favorites because that is the entirety of what they do.

    Me too. Always look at the angle. Always look for the scam.

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  30. 30
    rikyrah says:

    @randy khan:

    Can we haz ticker tape parade post?

    That would be a nice post….they could include nice pictures…pretty please?

    ReplyReply
  31. 31
    Gravenstone says:

    @Another Scott:

    (if it’s a huge market and will be opened up, why do new players need ‘incentives’?)

    I suspect there is a substantial initial capital requirement needed to enter this particular market. While it might quickly become profitable, that barrier to entry may be what the incentives would focus on.

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  32. 32
    jl says:

    @jl: Can’t edit my comment, so here is again, cleaned up a little

    I don’t have time right now, but I do know there are some reports on the issue. I’ll go find them later today or tomorrow and will link to them here. I think the consensus of health economists and clinicians who have looked into it is that it is a mix of greed and collusion and using price discrimination to suck as much economic value out of society as possible in return for providing the insulin. The increases in average price of insulin to large corporate providers has not been nearly as large as the increase in the list prices quoted in the news stories. So, if you have good insurance, a good, large, provider with buying power and the right connections and which decides that it wants to, or must, serve the needs of its diabetic population, then the insulin can be obtained at a reasonable cost. If not, the the insulin cannot be obtained at a reasonable price and you have no recourse except trying to stretch a very inadequate supply that is not up to current standards of care. The US patent system, which is internationally and historically extremely generous to corporate profits, plays a role. Bundling of pen and other delivery systems and the active drug under patent is allowed in the US that promotes ability to charge extremely high prices and keep newer insulin type products (the active drugs ithemselves) under eternal patent protection is allowed in the US in way that it is not in other comparable countries. This causes problems not only for insulin, but in the much lower availability of newer injection devices in the US for other drugs than in other countries.

    So, it is a horrible story of a horribly dysfunctional health care system. The problem is an infernal mix of several issues.
    I’ll alert you when I find the links.

    ReplyReply
  33. 33
    Barbara says:

    @kindness: Changing the priority for transplants is always a fraught issue. UNOS has a change in progress that is currently being litigated in Georgia. The question revolves around how to balance giving enough priority to local communities to keep them invested, without ultimately wasting organs that could be used by higher volume centers. In that case, they enlarged the regions that would be considered eligible for initial allocation, which means that a greater pool of patients would be considered and organs more likely to find a recipient (instead of potentially no longer being usable after having to wait to make appeals to the secondary allocation region). It has the effect of pushing down the priority of those individuals who were previously in the primary allocation list but overall it increases the number of people who will receive transplants. My view is that if the current system results in a lot of unused organs, you should try something new. There is simply no “fairest” way to do this. There is only a way that gets the most people organs.

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  34. 34
    raven says:

    How Trump Is Reforming Medicare, Part I

    Under a new CMS rule, Medicare will be moving toward parity over the next two years for billing codes covering about 50% of outpatient services. According to the CMS, current Medicare payment for a typical hospital-based clinic visit is approximately $116, with an average beneficiary copayment of $23. After two years, the payment rate for the clinic visit will fall to $46 and the beneficiary copayment will fall to $9, thus saving beneficiaries an average of $14 each time they visit the clinic.

    The American Hospital Association is suing to block the rule change. But this illustrates something important about the powers of the executive branch. Many of the reforms described here would have been done by Congress – but for the influence of powerful special interests.

    When Congress tries to reform health care institutions, special interests stop the reforms in committee. Under the Trump administration, increasingly the special interests must turn to the courts.

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  35. 35
    jl says:

    Trump’s July Fourth event and weekend protests bankrupted D.C. security fund, mayor says

    ” Bowser requested that the White House commit to fully reimbursing the fund.
    “We ask for your help with ensuring the residents of the District of Columbia are not asked to cover millions of dollars of federal expenses and are able to maintain our high standards of protection for federal events,” she wrote.
    The White House did not immediately respond to a request for comment. ”
    https://www.washingtonpost.com/local/dc-politics/trumps-july-fourth-event-and-weekend-protests-bankrupted-dc-security-fund-mayor-says/2019/07/10/fb0d1de4-a316-11e9-b732-41a79c2551bf_story.html?utm_term=.aaa6b5a2333e

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  36. 36
    jl says:

    @raven: I think the chances that Trump has any clue about these proposals is close to zero. It’s Azar. What the heck Azar thinks he is doing, making attempts at what appears to be good policy is an open question. I agree with commenters that nothing coming out of the Trump administration can be trusted, and it all needs to be watched closely no matter how good it seems.

    On the assumption that there are not dirty tricks buried in these proposals, the news is still bad since courts seem to think some of them need to go through Congress, but very doubtful that can happen given the level of corruption that rules our political system.

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  37. 37
    Barbara says:

    @raven: In fairness, Congress did begin implementing site neutrality for outpatient visits in 2015. It grandfathered sites already in existence. The White House proposed budget gets most of its health related savings from removing a lot of these exemptions, as well as imposing site neutrality for additional kinds of services. I don’t think the executive branch can wave a magic wand and remove the power of the statutory compromise.

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  38. 38
    Raven says:

    Even a blind squirrel. . .

    ReplyReply
  39. 39
    Brachiator says:

    I really wonder who Trump turned to for background on this decision. I don’t associate this administration with competence or listening to experts.

    Also, that this executive order depends on the continued existence of the ACA is goddam ridiculously par for the course.

    ReplyReply
  40. 40
    chopper says:

    @jl:

    lol, he’ll never pay.

    ReplyReply
  41. 41
    Ruckus says:

    @Gravenstone:
    It might not be the actual entry costs, but the risk that immediate ROI might not be “sufficiently high to make anyone interested. IOW it might be thought that they won’t make enough money fast enough.

    ReplyReply
  42. 42
    Ruckus says:

    @Raven:
    But a blind, dumb, deaf, racist, squirrel?

    ReplyReply
  43. 43
    Yutsano says:

    OT: Hawai’i has decriminalized the bud.

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  44. 44
    Starfish says:

    Our very own Hillary Rettig is a kidney donor.

    Also, I have a friend who has some kidney disorder that he was genetically pre-disposed to and desperately needs a transplant. He is in Texas.

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  45. 45
    Brachiator says:

    @Starfish:
    Stevie Wonder has been in the news recently, after announcing that he would be getting a kidney transplant in September. As a result, news about the procedure is being covered big time.

    https://www.freep.com/story/news/local/michigan/2019/07/09/stevie-wonder-kidney-transplant-living-donor-recovery/1672743001/

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  46. 46
    Feathers says:

    I used to work at an organ bank. Amazing people doing amazing stuff. However, I was astonished at the number of complete wingnuts working there. They kept it under wraps, but they would be talking about systemic problems in medical diagnosis and community healthcare issues in reasonably insightful way, and then saying how they liked what Trump was saying in the debates.

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  47. 47
    Barbara says:

    @Feathers: I met with someone who told me what a scandal it was that his state was at the bottom of all kinds of metrics for health status and that he was trying to start broader based community health outreach through a safety net clinic, and then told me that he was a big Trump supporter. The cognitive dissonance can be bewilderingly strong.

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  48. 48
    Barbara says:

    So I read the order. It’s a list of things that are going to happen within the next however many days. No details.

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  49. 49
    Keith P. says:

    @Yutsano: I would have figured they’d go full legal given that the other big weed states did.

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  50. 50
    J R in WV says:

    @Barbara:

    So I read the order. It’s a list of things that are going to happen within the next however many days. No details.

    No details !! What a shock !!! It’s a wish list with no path to achieve the wished for results… so not amazed.

    Thanks for taking the time to look up the EO and read it and then reporting back. Amazing!

    ReplyReply
  51. 51
    Barbara says:

    @J R in WV: I was probably a little harsh. CMMI does have some reimbursement models that it plans to roll out, but those have been in the works for a while and don’t need an EO to be implemented. They are supposed to start next January.

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  52. 52
    Quaker in a Basement says:

    Trump: (For reals!) “The kidney has a very special place in the heart.”

    Blaming the teleprompter on my mark….

    ReplyReply
  53. 53
    Dr Ronnie James DO says:

    When I was getting my masters in health policy, we were taught that the dialysis benefit in Medicare was put there to secure the hotel of a single Senator whose wife (?) needed dialysis, which was staggeringly expensive in those days.

    During my training with a nephrologist I worked with for a month, I gleaned the following:
    1) there’s a huge wave of kidney disease, which will get worse as a longterm consequence of the high rates of chronic disease (diabetes, hypertension, heart failure, which are all risk factors for kidney disease) continue to grow.
    2) Doing your own dialysis at home (usually peritoneal dialysis), which the Trump proposal is emphasizing, requires patients to be relatively competent / conscientious. Patients whom the nephrologists aren’t confident can handle it typically get put on center-based hemodialysis.
    3) The economics for nephrologists are rough (large volumes of medically complex patients); nephrology fellowship slots often go unfilled, and nephro training programs often shut down due to lack of interest (no fellows means no funding).
    4) about the only way for nephrologists to make “good money” (huge grain of salt, these are doctors talking) is to run a dialysis center. If dialysis centers close, I wonder if more of it will get even harder to recruit people to go into nephrology.

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  54. 54
    Another Scott says:

    @Dr Ronnie James DO: Thanks for the info. It’s good to be reminded of all the moving parts in situations like these.

    Cheers,
    Scott.

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  55. 55
    gene108 says:

    @Keith P.:

    Check and see, if any area hospitals are using Hep-C positive kidneys for non-hep-c positive recipients. The Hep-C will be treated after transplant. The issue is probably going to be, who will pay for the Hep-C treatment. Merck is sponsoring trials in a few locations and will cover the cost of treatment, using their drug Zepatir.

    Hope the EO can help with getting a kidney.

    @Barbara:

    Medicare covers post-transplant for 30 or 36 months after transplantation (forget which is the correct duration).

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  56. 56
    gene108 says:

    @Dr Ronnie James DO:

    In home dialysis, whether hemodialysis or peritoneal dialysis, requires a high degree of commitment from the person involved. I know in home hemodialysis, you are required to have someone else there during treatment, who will be trained on the equipment along with you. In home dialysis is much cheaper than in center dialysis, but it is not inherently cheaper or more comfortable for the patient.

    Instead of coming home and relaxing, you come home to your own personal dialysis center.

    One of the biggest problems for some set of dialysis patients to get on the transplant list is obesity. You need a BMI under 35 to get on the list, and some folks are well over that level.

    ReplyReply

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