Dialysis from the sharp end of the needle

The Dialysis Quality Incentive Program rule proposed - CMS calls for comments

By Bill Peckham 

On Monday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on the quality incentive program (QIP) required by Section 153 of MIPPA. Reading the 77 page PDF and the CMS Fact Sheet the proposal is about what was expected as a QIP starting point. 

The proposal is to use just three dialysis quality measures: Hemoglobin above 12; Hemoglobin below 10; URR above 65%, this represents no change from the QIP outline released in September. However, in response to comments received as part of the greater bundle comment process, CMS proposes to weight Hgb <10 as the most important of the three measures. Hgb <10 will count for 50% of your score, the other two measures will each count for 25%.

The PDF explains a pretty elaborate scoring system - it's a 10 point system for each of the three measures that together generates a Total Performance Score on a 30 point scale (30 is the highest score you can get), performance is measured against 2008 national averages (or 2007 unit performance, if it is lower) and the withhold is in .5% increments. 

CMS estimates that  3,205 units will see no payment reduction in 2012 because they will achieve a Total Performance Score (TPS) above 26. CMS estimates 709 units will see a 0.5% payment reduction due to TPS of 21 to 25; 183 units will see a 1.0% payment reduction for TPS between 16 and 20; 184 units will see a 1.5% payment reduction for TPS between 10 and 15; and only 30 units will see a 2.0% payment reduction for TPS 10 or below. In total CMS estimates that between 17 and 18 million dollars will be withheld in 2012.

Given the industry receives around 9 billion dollars a year in Medicare payments, 17 million dollars does not seem like very much but the basic framework of the QIP was created by Congress, not CMS. CMS does request comments on a number of specific points, page 48:

We are particularly interested in comments on how we can educate Medicare beneficiaries and their families about the presence of certificates in dialysis providers/facilities and how the information can be used to engage in meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care.

The certificates will report the facility's TPS.

Hmm ... "meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care" is a tall order from urea and hemoglobins under 10, but it is an invitation to give CMS your thoughts. I'd just turn the question around:

What would have to be reported by the TPS for it to inspire beneficiaries to have "meaningful conversations with their dialysis caregivers and the clinical community about the quality of America’s kidney dialysis care"?

Comments are due September 24th.

The Dialysis Payment Bundle - initial reaction

By Bill Peckham

The Centers for Medicare & Medicaid Services (CMS) issued the final rule creating a new bundled prospective payment system (PPS) for routine outpatient dialysis services. Skimming through the 900+ page PDF and the CMS Fact Sheet, I believe the new rule is an improvement on the initial proposal.

• It is gratifying that there is a Home Dialysis training add on which CMS included in response to comments, particularly comments from dialyzors.
• Oral-only drugs (binders) are not included initially but CMS will include them after 2014, following additional study.
• Covered lab tests will be those on a list, rather than all blood tests ordered by the MCP physician. 
• There are a lot fewer case mix adjusters - CMS at this time will not use a patient's sex or race/ethnicity to adjust payment.

Those are important changes that improved the final rule.

Trying to understand what happened to the actual payment amount is a little trickier. On page 256 of the final rule, CMS writes:

To summarize, the final base rate per treatment with an outlier adjustment & budget-neutrality is calculated to be $229.63. This amount includes a 5.93% reduction from $251.60 to account for standardization to the projected CY 2011 current system payment per treatment, a 1% reduction to account for outlier payments, and a 2% reduction for the required 98% budget neutrality.

This as compared to the the initial proposal in September as laid out in NN&I by Tracy J. Mayne:

The predicted 2011 mean bundled payment was $261.58. This number was then reduced 21.73% to adjust for "anticipated positive effects" of the impact of the case mix adjusters, or ways in which the new payment system might pay more than the current system. It was then reduced by 1% as a cost offset to pay for anticipated outlier payments, and by another 2% to meet the congressional requirement for a 2% reduction in ESRD spend in 2011, to equal $198.64.

Under the initial proposal the mean bundled payment was reduced by 21.73% to accommodate all the case mix adjusters, under the final rule with far fewer adjusters the mean bundled payment is reduced by 5.93% to get to the base payment. While it appears that there is a $30 increase in the base payment, it really is just an effect of having fewer case mix adjusters. However, it does appear that the payment amount was increased a few dollars in the final rule.

The final rule uses $251.60 as a starting point. In September CMS used $261.58 but that $261.58 included the $12.48 CMS computed was necessary to pay for oral drugs. Given oral drugs are not in the final PPS I would expect CMS to use $249.10 as a starting point ($261.58 - $12.48). Therefor, I believe 251.60 represents a $2.50 increase per treatment over the September proposal.

I think my math is right but I might have missed a 1% adjuster somewhere that would have gotten the numbers to match. I'll follow up once I've had more time to read through the complete rule.

I appreciate the amount of work CMS must have put in to review all the comments and fashion the final rule. I feel the effort I put towards understanding the proposal and commenting was worthwhile and led to a better PPS. I thank CMS for all their hard work and in particular their commitment to us on the sharp end of the needle.

CMS releases final dialysis payment rule

By Bill Peckham

http://www.ofr.gov/OFRUpload/OFRData/2010-18466_PI.pdf

The rule has been released. Lots of reading to do.

Still waiting for CMS to release the final dialysis PPS rule

Here it is a week later than my "best guess", just after 5PM on a Friday, and still the final dialysis payment rule is unreleased. It'll probably come out (just to spite me) when I am on the river and beyond the reach of the internet. I haven't heard anything - rumor, gossip or otherwise - about why there has been a delay. I last heard that the financial community was expecting the rule this week; the dialysis community was said to be expecting the release last week.

Google has DSEN pretty high up as a search result for people searching for news; if that's how you got here let me give you the links I've been checking:

• CMS's End Stage Renal Disease (ESRD) Center
• CMS End Stage Renal Disease (ESRD) Payment - Overview
• CMS End Stage Renal Disease (ESRD) Payment - Spotlight
• CMS End Stage Renal Disease (ESRD) Payment - Payment Regulations & Notices

One of these sites (or all of them) should announce and link to the final rule when it is released. If the rule is released between 7/19 & 7/23 you'll have to wait until I return, for the POV from this sharp end of the needle.

CMS submits dialysis "Bundled" Payment Rule to OMB

By Bill Peckham

UPDATE 7/16/2010:
Here it is a week later than my "best guess", just about 2PM in DC. The rule could come out in the next three hours but if it doesn't then it'll probably come out  (just to spite me) when I am on the river and beyond the reach of the internet. Google has DSEN (this post in particular) pretty high up as a search result relating to people searching for news about CMS's final Dialysis Bundle rule, so if that's how you got here let me give you the links I've been checking for news:

• CMS's End Stage Renal Disease (ESRD) Center
• CMS End Stage Renal Disease (ESRD) Payment - Overview
• CMS End Stage Renal Disease (ESRD) Payment - Spotlight
• CMS End Stage Renal Disease (ESRD) Payment - Payment Regulations & Notices

One of these sites (or all of them) should announce and link to the final rule when it is released. If the rule is released between 7/19 & 7/23 you'll have to wait until I return for the POV from this sharp end of the needle.

>>>>>>>>>>>>>----------------<<<<<<<<<<<<<

ORIGINAL POST FROM 7/1/2010:
The Centers for Medicare and Medicaid Services (CMS) has submitted the End Stage Renal Disease Bundled Payment System final rule to the Office of Management and Budget (OMB) for final evaluation. This is the final step in a process that began last September.

Typically OMB review takes about a week and often these rules are released to the public on a Friday, therefore, the best guess is that CMS will publish the final PPS rule on Friday July 9th. A caveat is that OMB could request additional data, resulting in the rule ping ponging between the two federal departments for a few days, but the end is in sight. 

There have been rumors and hints of what will be in the final rule. I think the CKD advocacy community is expecting that oral meds will not be in the bundle (which means certain people owe me dinner). Of greater interest to DSEN, and the community of dialyzors that submitted comments, I hear that the final rule will include a separate payment accommodation for home training. If true, a meaningful home training payment mechanism will be the most important element of the new dialysis payment scheme.

CMS promises to monitor access and quality in wake of bundle implementation

By Bill Peckham

In bundling news RenalWEB links to a press release from Representative Stark and a GAO report (PDF link), that appears to be in response to questions from Representative Stark and Representative Lewis. The press release helpfully summarizes the GAO report:

• Populations of dialysis patients have varying costs. African-Americans, dually eligible and younger ESRD patients have higher-than-average costs, and Asian-Americans and elderly patients have lower-than-average costs;
• A majority of clinicians surveyed said that clinical factors, not demographics, drive variation in expenditures;
• GAO recommended that CMS monitor access to and quality of care for certain beneficiary groups as soon as possible after implementation of the new system;
• In response to the report, the Centers for Medicare and Medicaid Services (CMS) announced their intention to have a comprehensive system in place to monitor the quality of care once the bundled payment system is implemented next year.

I think the GAO report vindicates those of us who supported CMS's decision to not include a race/ethnicity patient level adjuster to the expanded bundle.

Representative Stark's press release also links to a letter from Jonathan Blum, Deputy Administrator and Director Center of Medicare (PDF link). The letter does not reference the variation in expenditures observed among race/ethnic groups, rather it promises to have a "comprehensive monitoring system" in place on January 1, 2011 because "CMS places its foremost concern on the impact of the change on beneficiary access and quality of care."

The questions unanswered are how does CMS define beneficiary access and quality of care? The letter does say that "CMS will soon issue a proposed rule on the QIP". The Quality Incentive Program will play an important role in encouraging quality care but no matter what is "soon" proposed, the QIP will not be able to do all that needs to be done. But at least quality has the QIP.

How to define and monitor beneficiary access remains an open question.

KCC/KCP anticipate that the final rule will leave oral drugs out of the bundle

By Bill Peckham

I learned something else while reading through the advocacy letters to the VA - KCC/KCP does not think oral drugs are going to be a part of the final expanded bundle.

The Kidney Care Partners/Kidney Care Council joint letter to the VA (PDF link) contends that the Veteran's Administration, in proposing to set their dialysis reimbursement at Medicare's allowed rate, is wrong because their "Proposed Rule’s Overly Simplistic Analysis of Medicare’s Payment Policy Fails To Accurately Anticipate or Capture Effects of Future Changes" as evidenced by the fact that the "Proposed Rule Fails To Consider Medicare’s ESRD Prospective Payment System “Bundle”." The letter then lays out the pending changes (my emphasis):

Beginning in 2011, the MIPPA statute mandates that Medicare payment for ESRD will be based on a bundled payment system (i.e., one “bundled” payment to the ESRD facility per-patient per-treatment) that includes:

(i) items and services included in the composite rate as of 2010;

(ii) injectable biologicals used to treat anemia – erythropoiesis stimulating agents – and any oral form of such agents;

(iii) other injectable medications that are furnished to individuals for the treatment of ESRD and are paid for separately under Part B, and any oral equivalent of such medications; and

(iv) laboratory tests and other items and services furnished to beneficiaries for the treatment of ESRD (excluding vaccines).²⁰

According to CMS’ proposed rule issued September 29, 2009, the costs for these items would form the basis for an unadjusted base rate per patient tied to utilization data from the lowest of three prior years (2007, 2008 or 2009).²¹

Actually those items and " Oral Drugs without an Injectable Equivalent" (i.e. binders) form the basis of the unadjusted base rate per patient as published in the Federal Register (footnote ²¹ is to the proposed rule as published September 29, 2010).

Oral drug's absence from the KCC/KCP summary is hard to explain unless they believe the final rule will exclude binders, which would be a very good result.

The VA should use Medicare reimbursement as a starting point

By Bill Peckham

On Thursday RenalWEB posted letters from KCP, DPC and two Senators, to the Veteran's Administration [note: all links are PDFs] :

Public Relations Firm for Kidney Care Partners Releases Three Letters on Proposed Rule To Use Medicare Rates for VA Dialysis Services 

• Kidney Care Partners-Kidney Care Council joint letter to the VA
• Letter from Senate Veterans Affairs Committee Chair Sen. Daniel Akaka and Committee Member Sen. Mark Begich to the VA
• DPC letter to the Department of Veterans Affairs

Reading through the letters was my first exposure to the issue but I think KCC/KCP/DPC  have a point.

To simplify ... the VA has about 10,000 beneficiaries dialyzing in non VA dialysis units all across the country. The VA wants to pay the Medicare allowed rate for dialysis, currently the VA pays a whole range of rates but often the VA reimburses at a much higher rate than Medicare. The letters advocate against the VA using Medicare's allowed rates. I agree. I don't think Medicare's allowed charges, as such, should be used by non Medicare payers. Medicare has hundreds of thousands of beneficiaries dialyzing; they get, the rate they get, based on that buying power. Medicare will always have the lowest rates because they have the most beneficiaries (Medicaid is a special case).

The VA is trying to piggy back onto Medicare's buying power but reading the KCC/KCP letter, by law the VA is suppose to negotiate their rates separately, which seems reasonable. Like any insurer with 10,000 dialyzors the VA should be able to negotiate better dialysis rates than the LDOs' list price but without a thumb on the scale the VA shouldn't expect rates as low as what Medicare allows. The letters suggest that the VA create a "a viable national rate" not tied to Medicare. However, the letters don't offer a reason why the VA should not use Medicare's allowed rate as their starting point. Why not set the VA's dialysis reimbursement at 200% of the Medicare allowed rate? Or 300%? Medicare's patient/facility adjusted payment would be the logical starting point to set rates.

Medicare is the industry's most sophisticated payer. Medicare reimbursement rules try to match reimbursement to costs - there are case mix adjusters, geographic wage adjusters. But more importantly Medicare is on the verge of changing how they pay for dialysis, the final rule on the expanded bundle could come out any day. On January 1, 2011 the new payment method will go into effect (or start going into effect for providers who choose to phase into the new payment over the next three years), expanding the bundle is suppose to improve dialysis reimbursement's financial incentives, therefor why shouldn't we be advocating for all payers to use the new bundle?

I think paying separately for EPO resulted in the misuse of EPO. The dialysis industry should accept the expanded bundle as the new unit of service and change billing for all payers, in concert with Medicare's reimbursement change. The VA should be encouraged to use Medicare's methodology as a starting point in negotiating a fair rate.

CKD Advocacy Community Needs to Take Their Binders

By Bill Peckham

The CKD advocacy community is calcified, they could really use some binders.

I spent some time this afternoon looking through the advocacy, professional and provider sites on DSEN's big link list. With two exceptions there is no mention of HR 3590 the Patient Protection and Affordable Care Act, the health insurance reform legislation signed into law last Sunday. When MIPPA passed there were numerous communications from all corners of the CKD advocacy world explaining the details of the legislation and its expected impact.

To date I have not seen a single communication from any advocacy group on the impact of the health insurance bill. Only the Lupus Foundation of America highlights some of the bill's provisions directly, while the American Society of Transplantation links to a pdf of the Bryan Cave Health Reform Update (March 24, 2010)(PDF link). That's it. No one else even mention the historic passage of reform that will unalterably change the CKD advocacy landscape. I didn't even see links to news articles let alone CKD specific analysis (I apologize in advance if I missed one - I looked).

How can it be, with all the highly paid analysts at the various DC lobbying firms, that no one seems to have looked at this bill through the CKD public policy lens? I believe that this bill makes obsolete many of the positions held by the dialysis and transplant community, does it? Does making insurance widely available obviate the need to extend Medicare immunosuppressant drug coverage? I think it does. Why hasn't any of the many organizations advocating for expanded access to immunosuppressants come forward with definitive analysis one way or the other?

I think that the legislation, by adding some 20,000,000 previously uninsured adults to the insurance roles, means that thousands of people who previously would have started dialysis without any health insurance will now start dialysis with private insurance primary. If those 20 million adults are average how many would be expected to start dialysis in a given year? According to the USRDS ADR the number of people who start dialysis each year is about 350 per million - so in that group of 20,000,000 you could expect 7,000 to start dialysis.

What would have happened before this health insurance reform? Here's renal social worker extraordinaire Beth Witten on what happens today:

I get calls and emails all the time from pateints, family members, social workers, Networks, etc. trying to find ways to help uninsured or underinsured people who are US citizens or permanent legal residents pay for dialysis when dialysis clinics refuse to accept them unless they have coverage for dialysis. I've heard my social worker colleagues lament the time they have to spend on teleconferences explaining situations that can't be fixed in the current health insurance system which denies coverage or charges premiums that are too high for people to pay. I've heard of providers donating money to AKF to get their patients premiums paid for EGHP (including COBRA) premiums so those providers can recoup many times what they've donated for as long as possible.

Does the new legislation address this issue as I think it does?

Where is the analysis from the KCP? From the KCC? I hear that maybe those with insurance through the exchanges would not be subject to MSP. One, if that is true it would be a good thing to advocate about but two, how could that be true? Many of the people in the new exchange could be expected to have not paid into Medicare - a self employed landscaper, for instance. Without any work quarters to qualify under the ESRD program it makes no sense to think that the exchange insurance would drop him due to illness. That would be a news worthy exception to how the bill has been described. 

Right now the number one advocacy issue in the dialysis world is KCP's call to push Congress to push CMS to pay more for oral meds if they're going to be included in the expanded bundle. DPC, AKF and ANNA have versions of the Capwiz letter on their sites. DPC, NKF, RSN and AKF sent a letter cosigned by the four groups last week. None of the organizations acknowledge the language signed into law that directs the GAO to conduct a study. None of the organizations acknowledge the changes to Medicare Part D that will likely increase appropriate use of the oral drugs in question.

Together, these elements of the bill the President signed into law will make it much less risky for CMS to add oral meds at a later date. It'll be less risky because CMS will be better able to judge the appropriate level of use and the cost of that level of use, if all Part B beneficiaries had access via dialysis. If it is less risky in the future, than it is riskier to proceed now. That is a very powerful message. Why isn't that the suggested message?

Why are the CKD advocates proceeding with the messages they developed pre passage of HR 3590 the Patient Protection and Affordable Care Act? Why is there no analysis of the impact on CKD policy issues available from any of the CKD organizations interested in public policy?

It is ironic that as CMS works to address the calcium balance among people who use dialysis, that it is the organizations that advocate on our behalf that could really use the oral drugs without injectable equivalents.

The letter I would write to Congress to solicit their help to get the best PPS

By Bill Peckham

I think it is fair to ask what letter I would support, as is often said, it's easy to be a critic. This is the letter I would like to read from four of the leading CKD advocacy groups. I changed the date and the approach:

March 25, 2010

Dear Members of Congress:

We congratulate Congress on the historic vote and the passage of legislation to reform the health system, HR 3590 the Patient Protection and Affordable Care Act. These reforms will benefit people with chronic kidney disease, particularly by ending the practice of excluding people with preexisting conditions from participation in the health insurance market and action to close the so called "Part D donut hole". Thank you.

The dialysis community has been working to implement previously legislated reforms, we are writing to ask your help with that process.

The Centers for Medicare and Medicaid Services (CMS) is in the midst of finalizing its End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Rule.  The rule implements provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) that require the Agency to establish a bundled payment system for dialysis services. CMS published the proposed rule last September 16th; the comment period closed December 17.

One measure in HR 3590 that is specific to the ESRD program, Section 10336, directs that:

The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system ...

We believe that this provision brings helpful clarity to the choices CMS must make as it prepares the PPS final rule.

In September CMS proposed to shift all oral drugs without injectable equivalents, including calcimimetics and phosphate binders (oral drugs), into the bundle. This proposed policy was the subject of the most public comments during the PPS's comment period. The vast majority of these comments, including the vast majority of comments from people who use dialysis, spoke against the idea of including oral drugs at this time. We feel this consensus position should be supported and we urge Congress to make clear that the GAO report is meant to be a prospective study, that this study should inform the future process of including oral drugs in the PPS.

We believe that CMS can implement the PPS program MIPPA requires in a way that improves care for individuals who need dialysis services and does not endanger the progress in quality of care made in recent years. However, for that to happen CMS must wait for the GAO to study including oral drugs, and allow the implementation of MIPPA to proceed without their inclusion.

We ask that you contact CMS to underscore the intent of your recent legislation. It should be made clear that the study required by Section 10336 should be completed before CMS acts to include oral drugs under the dialysis PPS. By clarifying the intent of the GAO report, you will be supporting the concerns of Medicare beneficiaries.

We asked the beneficiary community, the people who use dialysis, and their loved ones, to engage with the PPS comment process, and they came through with scores of thoughtful, actionable comments. Reading through these many comments it is clear that aside from the inclusion of oral drugs, beneficiaries are most concerned about CMS's method for including laboratory services (labs) and the inclusion of home dialysis training under the routine PPS payment. The comments not only identified the problems they offered solutions. These comments should be acted upon.

We request that you encourage CMS to take seriously the thoughtful comments of beneficiaries, and the thoughtful and actionable comments of the organizations who represent individuals who need life-saving dialysis care, including the undersigned.  The issues are complex and there is limited time to act, but CMS must get the policies right.  At stake is the health and well being of hundreds of thousands of Medicare beneficiaries.

Warm regards,

Maybe the idea is that members of Congress don't have to meet the various comment period deadlines but it seems to me that the place to advocate now is where legislation has created an opening.

The approach of getting Congress to challenge CMS's results could have unintended consequences. Assuming HR 3590 the Patient Protection and Affordable Care Act passes, advocates would be wise to build on the language to study the inclusion of oral drugs and hope that they made their case sufficiently on other issues while the comment period was open.

CKD Advocacy Groups Write Congress a Curious Letter. Why now? Why this?

By Bill Peckham

I'm happy to post this letter, as asked, from four leading CKD advocacy groups to members of Congress concerning the proposed Prospective Payment System for dialysis (PPS). These groups all represent themselves as speaking for those who use dialysis: Dialysis Patient Citizens, Renal Support Network, National Kidney Foundation, and the American Kidney Fund. However, I have to say that I find the letter's reasoning to be internally inconsistent, and I find their choice of issues do not reflect the priorities expressed in the public comments filled by commenters who self identified as dialyzors. 

DPC, RSN, NKF, AKF Letter

I would say that the top beneficiary issue is access to home dialysis; indeed sometime during the next several months would be a good time to ask Congress to voice support for home hemodialysis (HHD) and to ask CMS to encourage HHD in the final PPS but this issue goes unmentioned in the letter.

All four of the signers expressed support for fair home hemodialysis training reimbursement in their public comments to CMS (view all public comments, or download as an Excel file), yet in the letter to Congress this issue is conspicuously absent. The letter chooses to discuss: oral drugs, lab tests, an adjuster for African Americans, and ... a technical issue around a withhold due to the expected cost of providers who choose to phase into the bundle over three years. Come on.

First of all, how can you write a letter to Congress yesterday, this week, and not mention the health insurance reform bill? This signals obliviousness on the part of these advocates. In the left column of DSEN there is a link to The Hunger Site - you should click it. That's there to acknowledge that the provision of dialysis is not the most important issue facing society. The provision of dialysis is not the most important issue facing Congress. Or CMS.

This blog is focused on the provision of dialysis because it's important to me and people read DSEN because the provision of dialysis is important to them but let's not pretend it's the only thing that matters. The timing of this letter makes no sense to me; the content makes less sense.

The health bill that may well be signed by the President and go into law , in the next two weeks, contains the Senate language calling for the GAO to study the inclusion of oral drugs under the PPS. Why continue to bang on about CMS's lack of diligence in proposing oral drugs' inclusion when there is an obvious way for everyone to save face. Study the issue. Get it right. Support the concept of seamless care. These are not difficult positions to take. Additionally, the letter complains about the dollar amount being added to the proposed payment rate, that the amount is not enough to cover the cost of these oral drugs.

I don't think that is appropriate. No one has the full picture of what prices the providers could negotiate for these drugs. It is tempting to say it's not enough but how can you take a position when you don't have access to cost data? Part of my comment about including the oral drugs is that CMS doesn't have access to the cost data because it isn't being done. No one knows what it would cost to provide universal access to these important and useful drugs, so how can these advocacy groups take a position? Because of what they've heard? They should stay away from the numbers.

In general, I agree that the way CMS proposes to include labs is a problem but the way this letter makes the case raises questions. I don't think the primary issue is the copay - MIPPA clearly imagines labs are going to be included. The copay isn't that much and to the extent it is, the letter writers' complaint is with Congress not CMS. The letter is asking Congress to lobby against their own legislation. Tactically the problem is that that this letter raises the copay issue as an important consideration. This undercuts their next concern.

If lab copays are an important consideration. And if singling out ESRD beneficiaries to be the only beneficiaries responsible for lab copays is a problem. Why wouldn't those problems be problems with including a race adjuster? The race adjuster would mean higher copays too. ESRD beneficiaries would be the only Medicare beneficiaries subject to higher copays due to race.

Including a race adjuster could be said to levy a tax on people who self identify as African American. The additional copay due to the race adjuster could be $3 a treatment or more. Ten times the additional copay due to labs tests. The letter asks that "The final rule should not increase the financial burden of care on dialysis patients" but copays will necessarily increase for some people, while for others copays will be less.

This dynamic is in the nature of expanding the bundle and is due largely to the inclusion of EPO. The letter, after raising the copay issue, ignores the varying copay impact of the race adjuster as well as the numerous adjusters that the PPS did propose, in favor of bringing up an obscure provision having to do with paying for providers who opt to phase into the bundle over three years.

That is an odd choice. That is an odd choice for patient centered organizations. I think there is a far more important issue to ask Congress to support.

I believe that at least 10% of Medicare beneficiaries would be happier and better cared for, if they were dialyzing at home. I think the leadership of the four organizations that signed this letter believe that at least 10% of Medicare beneficiaries who use dialysis would be happier and have better clinical outcomes if they were using HHD. That's 40,000 people. The current home hemodialysis training capacity in the United States is less than 4,000 people per year.

When you consider the training needs to replace those who get a transplant or go back incenter we will never meet the true demand for HHD without a magnitude increase in the number of HHD training slots. For every current training slot we need ten. For that to happen CMS will have to create a fair home hemodialysis training payment under the expanded bundle.

Reading the public comments submitted by people who use dialysis, creating a home hemodialysis training rate is the most important change CMS could make to the PPS, yet it isn't even mentioned in this letter. I find that curious.

Will dialysis provider consolidation accelerate under Medicare's new payment bundle?

By Bill Peckham

Fresenius Medical Doubles Acquisition Funding as Prices Fall, should not be unexpected news:

Feb. 24 (Bloomberg) -- Fresenius Medical Care AG, the world’s biggest provider of kidney dialysis, is doubling its budget for acquisitions to as much as $400 million this year as pressure on health costs presents opportunities for deals at attractive prices, said Chief Executive Officer Ben Lipps. 

Fresenius Medical, based in Bad Homburg, Germany, may spend as much as $200 million of the funds outside the U.S., said Lipps in a telephone interview today.

What is unexpected is that the amount really isn't that much, $200,000,000 doesn't buy much in the dialysis business.

Providers are sold largely based on their census. Really. It sounds truly horrifying but there is no way around it, dialysis providers are sold based on how many patients they treat. Sales prices are seen as a per patient sales price. Case mix, local demographic trends and strategic decisions influence the per patient price but generally a 2,000 patient provider will sell for ten times the price of a 200 patient provider. There are undoubtedly size and market dominance premiums paid - a provider that is concentrated in a geographic area would likely have more valuable patients than a provider with 10 units in 10 states. However, until a unit sells in today's market, you don't know today's going rate, let alone the going rate post bundle.

The article implies that Lipp's expectation is that sellers are likely to lower their prices going forward and at the right price Fresenius is buying. I believe back in 2005 to 2007 during the big mergers period, and then in the subsequent unit spin off and smaller mergers period, the per patient price ranged from $80,000 to $120,000. If units sell in that range this year $200 million would buy between 2,500 and about 1,700 patients (without accounting for provider debt, the more debt that comes with the deal the more patients $200 million will buy). Thousands of people are a lot of people, but keep in mind natural growth at Fresenius should be about 6,500 patients in 2010 (given a 5% growth rate).

Just to meet the growing need in the communities they already serve, Fresenius will need to build 1,200 stations minimum. Each de novo station cost $100,000 and up to build. It's likely that Fresenius will be spending about the same amount this year on natural growth, as the article suggests is available for acquisition growth.

Bloomberg missed an opportunity to pin Lipps down on what price providers are asking right now. What exactly are these expectations that are too high? And how much does Lipp's expect expectations to decrease because of the details of the final rule? How much exactly, might the proposed rule decrease small provider value?

In my comment to CMS on the dialysis PPS I wrote:

I believe Congress’ intent with MIPPA's low volume provision was to support dialysis choice and access.  Congress recognizes in the US that the provision of dialysis is an oligopoly. An oligopoly mostly funded by Medicare, an unprecedented situation.  CMS should define “small volume” as units owned by providers who serve fewer than 1% of the total dialysis census so as to allow beneficiary choice, encourage competition, and support the industry's engines of innovation. A low volume adjuster so defined will help balance the oligopoly by giving truly small providers additional resources to operate under the new payment rule.

There is no catching up to the purchasing power of the two large dialysis organizations. They will only get larger and more powerful.  The PPS can only maintain provider ownership neutrality if it includes an adjustment for the nation's small dialysis providers. With out an adjuster for small dialysis providers the PPS massively favors large dialysis organizations. Neutrality requires the adjuster.

If the "Bundle Tax" is too high, prices will fall and consolidation will accelerate. But as I write, there is an alternative.

Hopefully the final payment rule will be provider neutral. Instead of burdening small providers and driving down their value the final rule will create a payment that supports provider diversity with a reimbursement adjuster for the nation's small providers. Further dialysis provider consolidation is not in the interest of those who use dialysis today; further dialysis provider consolidation is not in the interest of those who will need to use dialysis in the future.

Sex in the bundle - good or bad?

By Bill Peckham

Jack Ahern has an article up on Renal Business Today reviewing one element of the PPS. Ahern asks Do Women Really Cost More to Dialyze? (Bundling Sex). The PPS included a sex adjustment, Ahern includes some of the relevant text concluding with:

As would be expected, CMS treads softly on the idea of differentiating payment by sex and solicited your comments regarding “unintended consequences of providing a payment adjustment for female patients that may lead to admission practices favoring female patients.”

Does this adjustment, which will impact ESRD payment possibly for the next 20 years, make sense to you?

No, it doesn't make sense, not yet anyway.

There is no evidence that this EPO disparity between the sexes will persist after the bundle is expanded, after EPO becomes a pure expense. For the most part all the new case mix adjusters proposed by CMS were based on current correlations to EPO use. The entire premise of expanding the bundle is that making EPO a pure expense means less will be used; this also means it is fair to say that the premise of the bundle is that EPO is currently being overused. It seems we are to assume that this EPO overuse is layered over the system like a tax - everyone is using 10% too much but that is a big assumption.

It is more likely that this EPO overuse is clustered and skewed. Is this overuse skewed towards woman? We don't know. What are the demographic/clinical characteristics of those that are non-responsive to EPO therapy? I don't think we know, or at least CMS makes no note of it. Given that, CMS should not include any of their proposed EPO based adjusters (adjusters meant to accommodate the observed historic differences in EPO use). They should go forward with a minimum number of case mix adjusters and monitor the use of injectable drugs and other measurable dialysis cost centers.

If there are usage disparities after the bundle is in effect, then that is the time to devise case mix adjusters. Which case mix adjusters will be included in the final rule is a situation ripe for wagering. I hope for simplicity's sake, if nothing else, the clinical case mix adjusters are few: today's adjusters (age, BMI, BSA) along with a scaled back first four month adjuster. We'll see when the final is published, but with the snow and federal office closures, the final rule release date probably just got pushed back a week.

Reading the tea leaves: does CMS transmittal signal oral drugs are not in the bundle?

By Bill Peckham

I was interested to read The CMS's Program Transmittal on Dialysis Adequacy, Infection and Vascular Access Reporting (PDF link) that was linked to by RenalWEB and NephrOnline. The transmittal relates to the Quality Improvement Program (QIP) that is a feature of the Prospective Payment System (PPS) required by the Medicare Improvements for Patients and Providers Act (MIPPA). After providing background the transmittal lays out new reporting requirements:

B. Policy: The CMS will require the reporting of the Kt/V reading and date of the reading, vascular access and infection data on ESRD claims with dates of service on or after July 1, 2010. This new data reporting requirement will allow CMS to implement an accurate quality incentive payment for dialysis providers by January 1, 2012, as required by MIPPA §153c. CMS is requesting a July 2010 implementation date because the quality incentive payment must be in part based on provider improvement over time, thus, CMS requires an accurate measurement of baseline provider performance. The CMS will require that providers continue to report the existing G1 through G6 modifiers for URR at this time.

There is no mention of bone measures. Does this mean that oral drugs will not be included in the PPS required by MIPPA? Like the dog that did not bark, it is suggestive.

As the transmittal notes for a measure to be included in the QIP, CMS has to establish a baseline. As it stands, there isn't data for the sorts of reporting you would want to have in place if oral drugs were going to be part of the PPS. If CMS was planning to include oral drugs I would expect them to measure bone health outcomes e.g. PTH, calcium, phosphorus. If the transmittal included phosphorus or PTH, their inclusion would signal that CMS is preparing to include oral drugs (in the foreseeable future). However, you can't be sure their absence signals oral drugs are out. There could be another transmittal on the way!

We'll have to keep watching, and reading the tea leaves until the final rule is released in the next several months. When, exactly, is that going to be? I'd say April if it is an interim rule (another comment period!); June if the rule is released in final form. These are just a wild eyed guesses on my part, however, pushing the QIP implementation into 2012 (I think this transmittal means 2012 will be the first year payment is at risk/2011 would be the base year) signals that the expected round of proposed rule making focusing on the QIP is going to be held off until the final PPS rule is released.

The final rule does have to be released sometime this year. In enough time to allow providers time to get ready. If I had to guess one date, I'd take June 30 ... right before the long July 4 weekend.

Using dialysis for healthcare fear mongering is tricky if facts matter

By Bill Peckham

Last week Renal Business Today linked uncritically to Dr. Richard Amerling's Medicare Rationing Begins in January, 2011, an article that manages to shoehorn in a greatest hits of healthcare political bogeymen while presenting the provision of dialysis as an early example of the heathcare dystopia that is just around the corner.  It's all here: private insurance disappearing, death panels, arbitrary reimbursement cuts, rationing, federal micromanagement,  congressional mismanagement, and nationalization of healthcare! Oh my.

Let's go through doctor Amerling's article from its start to its penultimate paragraph of doom. He begins:

House and Senate Democrat leaders, and President Obama, argue that they can "pay for" health insurance "reform" by cutting $500 billion from Medicare spending over the next decade—largely through arbitrary reimbursement cuts,— without reducing the quality of care delivered to beneficiaries.

Actually it is the Congressional Budget Office that scored the Senate's healthcare legislation as saving billions of dollars over 10 years (and even more in the 10 years after that). The cuts have a name, Medicare Advantage, but since talking about Medicare Part C causes people's eyes to glaze over why not call them arbitrary reimbursement cuts? That aside Amerling's question is: Can Medicare be cut while maintaining or improving clinical outcomes? Amerling doubts it is possible. He continues:

Yet, in January, 2011, Medicare will implement a new payment system for patients receiving dialysis for end stage kidney disease that will severely ration care to this vulnerable (and largely minority) population based on equally arbitrary payment reductions. These patients will be the unfortunate canary in the Medicare coal mine: "reform" legislation will expose millions of Medicare patients to rationing and reduced quality of care.

Armerling is saying that the expanded payment bundle, the PPS required under MIPPA, will arbitrarily cut reimbursement and ration care to people who need dialysis, and this change in how dialysis is reimbursed is a model that will be applied to the detriment of other parts of Medicare, leaving bad quality and rationing in its wake.

Politically this bogeyman has never made sense, Medicare is a Made Man in the federal budget - it wont get hurt. Amerling then goes into a weird history of dialysis reimbursement:

In 1972, Congress passed legislation creating an entitlement to Medicare for patients diagnosed with end stage renal disease. The bill allocated about $140 per treatment (or $1820 per month) per patient. This facility fee was large enough to incentivize the creation of dialysis centers, the expansion of dialysis treatment to all patients, and an end to what were very real "death panels." The ESRD program became a model for what good government could accomplish. There was broad consensus that payment for this catastrophic illness was a legitimate federal function and use of taxpayer funds. Unfortunately, Congress neglected to index the payment for inflation, leading the constant-dollar value to dwindle to around $14 per treatment. Dialysis units were able to survive, and even prosper, by aggressive cost-cutting (substituting technicians for nurses), consolidation into ever-larger chains, boosting efficiency (sometimes by cutting treatment times with a negative impact on outcomes), and by generating revenue from sales of drugs used during dialysis.

The panels that selected people for dialysis were choosing who would live not who would die but beyond that the numbers are a mess (for an authoritative review of early dialysis payments policies and amounts see this 2000 paper by Eggar (PDF link)).

The history ignores that for comparative purposes, the dialysis payment rate was set in 1983 at $127, which you can discount into today's dollars but what is really curious is that when describing how units managed to survive under stagnant payments Amerling leaves out the most important piece - accepting Medicare gives providers license to vastly inflate prices charged private insurers. This dialysis provider feast period known as MSP is the main net income engine for the industry. How could private payers be missing from this history? In the next paragraph Amerling identifies injectable drug margins as "the major source of profit for dialysis units". That's not true, commercial payers are the major source of profit for dialysis units.

The next two paragraphs are taken up with a discussion of EPO's separate payment history and how studies published in the last two years caused Congress to act in 2003 to bundle EPO. The key point Amerling makes about EPO is that:

the payment model that had evolved led to incentives to prescribe that were potentially hazardous, and needed reform.

It is nice to see someone from the Manhattan Institute for Policy Research acknowledge fee for service medicine results in overuse without clinical benefit but remember Amerling's premise is that the Obama administration's promise that Medciare spending can be cut while improving outcomes is false. This statement says the Obama administration is right.

The current payment model causes units to overuse EPO. Which is a financial problem but even more importantly is a cause for clinical concern. Therefor if you change the incentives to motivate doctors to use the right amount of EPO you could spend less and get better care. Now there is a lot to be said about how the  details of the PPS came out and whether it would be truly budget neutral but there was a comment period, CMS could listen and improve the bill, so Amerling's next five paragraphs are premature. They require the PPS to go into effect unchanged.

If that were to happen it would not be as good a payment system as Medicare could devise. I spent 4,000 words saying what I thought could be improved and I have bet knowledgeable renal insiders that the final rule will not include oral drugs - but the insiders think oral drugs are going to be in, so I maybe I'm wrong. However, Amerling's analysis is off no matter the shape of the PPS in the final rule. In evaluating the value of the proposed bundle Amerling compares the $235 UMKECC came up with against the $198 base rate CMS used in the PPS. That's apples and oranges.

There is no doubt the PPS payment rate is confusing but Tracey Mayne did an impressive job breaking it down for Nephrology News & Issues:

The predicted 2011 mean bundled payment was $261.58. This number was then reduced 21.73% to adjust for "anticipated positive effects" of the impact of the case mix adjusters, or ways in which the new payment system might pay more than the current system. It was then reduced by 1% as a cost offset to pay for anticipated outlier payments, and by another 2% to meet the congressional requirement for a 2% reduction in ESRD spend in 2011, to equal $198.64.

The base rate before case mix, the number comparable to UMKECC's $235, is $261.58 less $13 (the 1%, 2%, 2%) or $248 compared to UMKECC's $235. But wait, don't forget the $14 for oral meds that CMS included in the payment. UMKECC didn't imagine Part D meds in the bundle so they are not reflected in the $235. Take away the $14 and you have $234 vs $235. Given rounding the CMS's PPS payment rate is what UMKECC suggested.

In the second to last paragraph Amerling warns that:

Even the large dialysis chains will struggle to remain afloat. Their situation will worsen dramatically if private insurance (which covers dialysis at rates well above Medicare) disappears as a result of the added costs and regulatory burdens imposed on them by ObamaCare. In effect, this legislation sets the stage for an eventual nationalization of the dialysis industry.

Where to begin?

The article is full of dissonance but to suggest the large providers are at risk in all this is not credible. A lot depends on what the PPS looks like in the final rule but since the payment is based on historic overuse of EPO there should be some room for all units to improve outcomes and cut costs by using less of the expensive drug. The large dialysis organizations have shown they want nothing more then to expand, they want more of the healthcare pie not less.

But finally, here there is mention of private insurers. Until now you would not know they had a role in financing dialysis. Amerling's apparently believes that covering people who are uninsured will decrease provider profits - this doesn't make sense. Looking at insurance industry equity prices in response to the Senate bill suggests that insurers are set to benefit under Obamacare. Far from disappearing to produce Hollywood blockbusters the insurance industry looks to be entering a growth phase.  Amerling imagines all this somehow culminating in nationalization of the dialysis industry.

Really? Nationalization. In other words Medicare would own the dialysis units, pay the staff, buy the equipment. Amerling is imagining that somehow the federal government will be the only entity willing to provide dialysis after insurers and dialysis providers leave their industries to do other things. That's farcical but today some people consider this sort of hackery thoughtful commentary. 

There is an interesting free market take on the provision of dialysis but Amerling actually dismisses it early in his piece by writing that "there was broad consensus that payment for this catastrophic illness was a legitimate federal function and use of taxpayer funds." At least there we agree.

PPS Comments to Medicare show the way forward: higher dialysis doses for better health

By Bill Peckham

I noted in my PPS comment to CMS the level of distrust that I heard as I read them in mass. Reading them one after another, as they were posted started making me feel cynical. However, there is another narrative in those nearly 1,200 comments, another story. A story of hope.

Here are excerpts from 23 comments submitted by those using frequent home hemodialysis (these comments were mostly submitted through regulations.gov, which limited text box submissions to 2,000 characters (not even 15 twitter messages). The process also stripped away paragraph formatting. I, for the sake of readability, added paragraph breaks to the messages and let my spell check correct some obvious typos. You can read these and all comments in their posted form here or download a continuously updated Excel file). The stories excepted below offer a glimpse of a brighter dialysis future. A future that can be achieved today, without waiting for a scientific breakthrough or the FDA approval process.

Read these and hear what they are saying. Taken together these comments offer as strong an endorsement of more frequent dialysis as I've ever seen. Story, after story of being cured of the symptoms of too little dialysis. All of the symptoms that people mistakenly attribute to dialysis, are reported cured. And not one of these commentators talk of urea.

Read through these personal testimonies, and then look around a dialysis unit. Should those people, those individuals really be there?  People with CKD5 don't have to feel that sick - there is an alternative to conventional incenter dialysis.

CA Dialyzor
Dear Sir/madam, I am a 42 year old home hemo patient of 5 years, I work 9 hours every day and exercise regularly.

I am also extremely grateful to be able to dialyse 6 times per week for 6 hours every night as a result I have no pressing need for a transplant, and climbed Mt Witney in August.

I used to have in center dialysis 3x per week and was not able to work a full day or keep myself fit. I feel that others may not be able to enjoy a productive life if sufficient encouragement to move patients home is not created by the new payment system. ...

GA Dialysis Mom
Thank you for the opportunity to share my thoughts on the Proposed ESRD Rule. While I am a healthcare professional, I never thought I would have an interest in dialysis- but that changed when my daughter developed kidney failure.

She was transplanted at age 11, but the new kidney did not last. After that, she tried peritoneal dialysis, but had many infections. Incenter dialysis was the only other option we were given, and it did keep her alive- but it put our whole family in survival mode. I had to quit working to take her to all her treatments and be here when she slept afterwards. We thought that was the only way. But, in 2007 I heard about home hemodialysis. This therapy has given us back our daughter and given our family back a life. ...

CA Care Partner
My husband returned to dialysis in 2006 when his kidney transplant failed. While dialysis was much improved since his experiences 1990-91, the most marked improvement was what we experienced when we began home hemodialysis in 2007.

His general health and quality of life increased enormously. It was more than worth the effort, even considering the fact that home hemo includes a lot of work for the patient and caregiver, particularly when compared to clinic hemodialysis. ...

CA Dialyzor
I am a kidney dialysis patient for almost 20 years & a home dialysis patient for the last 3 years. As a result of home dialysis I am off many of the medicines I had to take when going in center for treatment because doing dialysis at home is almost like having my kidneys function again. ...

MN Dialyzor
I am a 22 year old home dialysis patient, and "going home" when I do treatments has changed my life dramatically, in only the best ways. I want to first thank everyone for still supporting this treatment option, because it has been in integral piece to my continued health and life satisfaction. I was diagnosed when I was 7 with MPGN type two, and have been on some form of dialysis since 1997.

I remember the days when I had to go into a center to do dialysis, and having to do my treatments on their schedule and how it fit into their day, actually worked against my ultimate goal of living as "normal" a life as possible. When I learned that I would be starting to do it at home, both me and my family were very excited. We had some amazing nurses who trained us, and who were there for us in a one on one fashion to learn how to be independent, and because the training is one of the most important pieces to the puzzle, I think that making it "part of the package" would only be detrimental to the program. I want all of those people out there that are just as scared and nervous as I was when I began to have the same experience that I did with amazing trainers who will help them feel comfortable enough to take it home, and live an amazing fulfilled life just as I am!

UT Dialyzor
I have been on NxStage home hemodialysis for 3 1/2 years. My health has improved remarkably. I live 90 miles from a dialysis center and I made that trip 3 times a week for one year and the trip itself almost killed me. I did it or 4 years in Montana and had to drive nearly the same distance. Home Hemo gives us the patient freedom and better health.

My health is remarkable as if have been fighting ESRD for 22 years. Had I not been enabled to do NxStage home hemo I would have certainly met my demise by this juncture. In center is good but home hemo is so much better. The care one gets from their loved one as the service provider is unfounded anywhere. The peace and saftey from infection is also reflected in my health with home hemo. I just cannot say enough that Home Hemo has saved my life! If I had to go back to in center and drive 180 miles 3 times a week I would soon be dead in body and spirit.

Home hemo renews one's spirit and the ability to stay at home and not make that awful trip cannot be traded for anything. If you were to take a photo of me now and 4 years ago before I started NxStage home hemo you would not know it was the same person. My health has been renewed. ...

OH Dialyzor
i have been on dialysis since 2002. in 2006, i started going downhill. my wife drove me to dialysis and got a wheel chair to take me into dialysis. we found out about nextstage on the internet and looked into it. we began training in January of 2007. after just a week of the training i felt good enough to drive and my wife and i stopped for lunch for the first time in over 2 years. NxStage dialysis has given me and my wife a much fuller life.

UT Care Partner
To whom it may concern, My husband Brad has Alport's Syndrome which is ESRD, he was diagnosed when he was only 34. We have 4 children and have spent the last 9 years learning how to best deal with this disease. It was life altering as you can imagine.

First I would like to say without Medicare we would have less than we have now. It has enabled our family to continue moving forward. We heard of the changes that will be taking place and want to make sure our voices are heard. Brad has been a Home hemodialysis patient for the last 7 years, 2 which have been on the NX stage Nocturnal program, meaning he dialyzes at night for 8 hours.

This has enabled Brad to hold down a full time job, go off of his high blood pressure meds, and forgo Aranesp shots because his body is functioning on a more normal level. ...

KS Dialyzor
To Whom It May Concern' As a current home dialysis patient and a past in-center patient I want to thank you for the availability of home dialysis. The difference in how I feel on HD as opposed to in-center is remarkable.

My high blood pressure which was at the stroke levels previous to HD is now completely under control allowing me to take less medications. The frequency of dialysis has also helped me to feel better, sleep better and eat better resulting in an overall improvement of my health.

My lab values particularly phosphorus and potassium have lowered significantly. I can only assume this is due to the frequent dialysis treatments I receive which HD. My only concern is with the possible bundling of treatment which would eliminate training sessions for some units. I ask you to think carefully about the change in this rule as it may keep others from reaping the many healthful benefits from this type of dialysis.

NE Dialyzor
I have done all forms of dialysis: PD and hemo. Over 8 years of surviving this way at 42 years old. I struggled along for a very long time until it was suggested that I try home hemo and overcoming the fear of poking myself I tried.

I have since avoided being in the hospital every year around July for quiet some time. I feel better and can function at a higher degree due to my fluid being removed more often. I walk and ride my bike and love it. I don't just survive, but I live!!!! Trust me living and enjoying life is huge when you have kidney failure. The windows of how often you feel good is small and even smaller when you are required to go to in clinic dialysis.

There is great freedom given when you allow me to stay home and hook up and not go by the clinics clock, but mine. I get to attend meetings and family fatherings and church functions because I choose when I do dialysis. I love this freedom. Please do not take this from me. I can travel and visit friends and not have to worry about setting up chair times so far in advance. I am an active person and am so pleased to have better health and am able to participate with gatherings and groups where as before I was very limited. ...

CA Dialyzor
I am a home dialysis patient. Home dialysis has made my life bearable. The more frequent and gentle treatments have done wonders.

Before with dialysis in the Dialysis Center four times a week, I had a tremor that made it difficult to even use a computer and I had small seizures several times a minute. These symptoms of subtle uremic poisoning did not go away with regular in center dialysis but did with daily home dialysis. Please support daily home dialysis. ...

WI Care Partner
CMS, THANK YOU FOR PAST SUPPORT. BECAUSE OF HOME DIALYSIS I HAVE BEEN ABLE TO TREAT MY HUSBAND AND STILL WORK MYSELF.OUR DR. ENCOURAGED US AND THE NURSES TRAINED ME( I'M NOT A NURSE) AND ARE AVAILABLE 24/7. HIS HEALTH HAS IMPROVED BECAUSE OF DIALYSIS 6 NIGHTS A WEEK. HIS CARDIOLOGIST SAYS HIS HEART IS EVEN STRONGER. SOME MEDICATION DOSES HAVE BEEN ELIMINATED OR LESSENED. THERE IS NO FEAR OF CATCHING FLU OR COLDS FROM OTHERS BECAUSE WE ARE HOME IT'S BEEN WONDERFUL HE IS 82 AND SAFE AT HOME. ...

CA Dialyzor
I live in a remote area near Willits and about 30 to 40 miles from a HD treatment center. With out HHD I would not be able to live where I do for many reasons.

When I was in a Treatment Center with treatment 3 times/week I never really felt good (It was like a light bulb being on but not giving off as much light as it was designed to). I got sick more often and not able to do anything else that day due to travel, treatment time, and fatigue.

I have been doing HHD 6 days/wk for the past 5 years. For the past year + I have been doing NOCTURNAL which frees up my days. I love it, I FEEL GREAT! My check ups and blood workups are always very good. So, thank you CMS for supporting HHD treatment. ...

AR Dialyzor
I would like to thank CMS for the continued support of home hemodialysis. I completed my training in June 2009 and have been utilizing HHD since that time.

I am 40 years old, married, and have two (2) young children. My wife went through the training with me and is my care giver. Being able to perform my dialysis on my schedule has allowed me much greater flexibility and time with my family. I utilized in-center hemodialysis for approximately six (6) months prior to HHD training and I feel much better on HHD.

HHD also allows me to travel - we have taken two (2) trips where I simply take my machine with me. This has been incredibly important for my job as a work 40+ hours/ week. ...

KS Dialyzor
Dear CMS, I am a home Hemo Dialysis patient. I am on the NxStage system. I have been on dialysis since 10/08 and started home dialysis in 6/09. I must say the initial training for this services was quite extensive, lasting over two weeks but it was very worthwhile and highly effective.

Being on home dialysis has allowed me to return to work full time, 8 hrs a day, 5 days a week. I also have been able to resume normal activities on my 22 acre farm. ...

MA Dialyzor
I have been a HHD paitent for the past 3 years and I feel that anyone who can do it at home should do it .

It gives you more freedom and helps keep your life as close to normal as possible. ...

FL Care Partner
A year ago my husband and I were barely familiar with Dialysis nor did we even consider the ramifications of kidney failure. The funding of the programs via Medicare and terms e.g. bundling, composite rates, etc. were furthest from our minds. However, fast forwarding to the present, we have learned in the last eight months that without dialysis my husband would cease to exist.

While our medical bills were piling up we were introduced to a home hemodialysis program that provides him with life saving dialysis at home with me as his caretaker. Do you have any idea how valuable it was to have an excellent training nurse instructing us for home hemodialysis? I am close to 70 yrs. old with no medical background and with our excellent training from a dedicated dialysis nurse we were able to start his dialysis in our home.

We have been able to keep my husband out of the hospital and gave him back the gift of living. The difference in his health is amazing, he has reduced his blood pressure meds and the daily home hemodialysis training is priceless. ...

NC Family/Care Partner
I am writing to share my concerns about your proposed changes to the way dialysis is covered and paid.
...
2. Home Hemodialysis training- thank you for being aware of home hemodialysis. It is the real thing and has totally changed our lives. Seriously, my brother was in a wheelchair and slept most of the time when he was treated in the unit. He was in the hospital regularly.

Since going home on hemodialysis, he has not been in the hospital a single time! He even volunteers at the hospital now!!! It has been life changing for our whole family. I have returned to teaching, after having stopped to care for my brother when he was in the unit. ...

TX Dialyzor
I am on hemodialysis in a home administered plan. Because of the individualized training my wife and I received we are able to successfully perform my dialysis in the comfort and privacy of my own home.

I went to the center for treatment for two months. During that time I was washed out every other day after in center dialysis. At home, I have dialysis 6 days a week and feel wonderful the minute I'm finished. I can travel any time and at almost a moment's notice. I've taken 3 to 4 week vacations across the country to visit family members that can no longer travel, and I went with my whole family on a cruise. I would not have been able to do that without the home hemodialysis.

Because we were well trained on an individual basis, we feel comfortable and capable of performing the treatment no matter where we are. Because we can set our own schedule, we are able to participate in community, church, and family events. We do not feel like we are missing out on life.

I had my yearly evaluation last week and it was wonderful. My health is good and I'm living my life to the fullest. I pick up my grandson every day after school and recently got a new granddaughter. As quickly as children grow I could not have had this time to spend with my children, grandchildren and siblings.

Spouse of above Dialyzor
My husband is on home hemodialysis. I am not a medical professional and when I first heard about home hemodialysis I thought it would be impossible for us to do that. I received individual training and because of that I was able to learn what I needed to be comfortable enough to perform hemodialysis in my home.

My husband went to in center dialysis for a couple of months. During that time he was terribly depressed. He would drive himself to the center but was unable to drive home (It was a 40 minute drive and we were at the center approximately 5 to 6 hours). I was unable to work during that time because I had to drive him home from the clinic. When he finished his treatment he was barely able to walk to the car.

He had no appetite and was losing weight. His blood counts were going down because of his lack of appetite. Now when he finishes his treatment (6 days a week instead of 3) he has plenty of energy. He can get dressed and be ready for anything. We vacation, spend time with family and friends, and participate in church activities.

My husband also belongs to the local Exchange Club and the Lions Club. He was not able to do that when he went to the in center dialysis unit. Please don't change anything. This has allowed my husband to live a fuller life and to feel so much better than he did in center.

MA Dialyzor
Response for Proposed Medicare Bundling Rule Thank you CMS for making all options available I agree per treatment payment is best way to support frequent hemodialysis.

Since being on frequent home hemodialysis I have noticed a tremendous change in how I feel physically and emotionally. Physically I have more energy, my diet is more liberal and I have more time to enjoy life. My life has changed significantly since starting on frequent home hemodialysis, instead of dialysis being my whole life it know is a part of my life.

I ask that you not punish clinics that offer more frequent hemodialysis but make it more available and financially acceptable. Since being on frequent home hemodialysis I have noticed decreased illness which brings down any potential hospital stays that I might have had. Since being on frequent home hemodialysis I have decreased my B/P meds significantly. ...

AK Dialyzor
To whom it may concern, Thank you for allowing me the opportunity to comment. My name is Stan and I have been on dialysis since May 2009.

I was initially on in-center for the first 3 months and have been on home hemo since. I lead a very active lifestyle with my children. I also continue to work full time. I really appreciate the rules allowing for home hemodialysis and short daily treatments.
...
I hope it will be possible to make modifications to ensure that every dialysis patients is able to receive the optimum treatment, and not just the minimum required to keep them alive. It is important to many of us to remain healthy enough to continue to be a contributing member of society

VA Dialyzor
Making all dialysis options available in the bundle rule certainly makes sense. I am very appreciative of the many different types of dialysis that is offered in this setting.

Seven years ago, my kidneys began to fail & my doctor advised dialysis. One of the options was home dialysis. Choosing this, I signed up for the class. However, before I could start the training, I suffered a heart attack & congestive heart failure. My dialysis then became an urgent necessity & I began dialysis in the hospital setting.

After my release from the hospital, I continued my dialysis treatments at the center, 3 days/week, and 4 hours/day. I did not feel very well after treatments; I itched, was cold, had cramping all the time & felt very weak. I have an IJ catheter. In the center they would run 500 speed to get a good clearance, but my machine's alarm would constantly go off. The motor speed was reduced, resulting in the poisons not taken off, as they should be.

I was 81 when I started dialysis & my wife (helper) was 74. Although skeptical of home training, we completed the training & all went well. I have been on home dialysis for 7 years and feel great. I am able to cut 4 acres of grass, visit with family, tend a garden, can vegetables and keep up with and order supplies. I eat what I want & my lab results are normally great.

I dialyze 5 nights/week, 8 hrs/night. Because each person is different, I believe CMS's per treatment plan options are best suited for everyone. Dialyzing this slow, long way is much better for my catheter & my well being.

I am now retired, but I know w/ home dialysis, my quality of life is much improved. This is reflected in my activities, my diet & my lack of hospitalizations.

I feel better all around & have been taken off blood pressure medication. I have only been hospitalized once in 7 yrs. for anything other than catheter problems.

These selected comments are in addition to the long home dialyzor submissions via Word or PDF document.

There are over 90 times as many people on conventional incenter dialysis as are on frequent home hemo, yet I can think of very few who, by any stretch, wrote to endorse their care. Only those at home, dialyzing more frequently, were moved to do so.  They know the truth, their stories tell of a better way.

Senate's Health Reform Manager Amendment: No Immunosuppressant Drug Coverage, GAO to Study Including Oral Drugs in PPS

By Bill Peckham

Ezra Klein reports that today Senate majority leader:

Reid released "the Manager's amendment (pdf)," a single piece of legislation that contains hundreds of amendments within it. This way, there is one big vote changing the bill rather than dozens, or even hundreds, of smaller votes.

This is the final amendment to HR 3590 the Patient Protection and Affordable Care Act, the Senate's version of health reform slowly working its way to a vote. The hope was that Senator Durbin would get immunosuppressant drug coverage into the Manager's amendment without a "pay for" mandating the inclusion of oral drugs in the dialysis payment bundle, which is the choice the House made a little over a month ago.

Unfortunately, the Manager's Amendment does not include any language relating to immunosuppressant drug coverage. There is, however, Section 10336 which calls for a GAO study of including in the dialysis payment, payment for dialysis related oral drugs (Page 249 - 250 PDF link):

SEC. 10336. GAO STUDY AND REPORT ON MEDICARE BENEFICIARY ACCESS TO HIGH-QUALITY DIALYSIS SERVICES.

(a) STUDY.—

(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) (pursuant to the proposed rule published by the Secretary of Health and Human Services in the Federal Register on September 29, 2009 (74 Fed. Reg. 16 49922 et seq.)). Such study shall include an analysis of—

(A) the ability of providers of services and renal dialysis facilities to furnish specified oral drugs or arrange for the provision of such drugs;

(B) the ability of providers of services and renal dialysis facilities to comply, if necessary, with applicable State laws (such as State pharmacy licensure requirements) in order to furnish specified oral drugs;

(C) whether appropriate quality measures exist to safeguard care for Medicare beneficiaries being furnished specified oral drugs by providers of services and renal dialysis facilities; and

(D) other areas determined appropriate by the Comptroller General.

(2) SPECIFIED ORAL DRUG DEFINED.—For purposes of paragraph (1), the term ‘‘specified oral drug’’ means a drug or biological for which there is no injectable equivalent (or other non-oral form of administration).

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

I have to believe this means oral drugs will not be included in the PPS required by MIPPA.

As to the immunosuppressant coverage piece, the hope now is that when they bring the House's HR 3962 and the Senate's HR 3590 bills to conference, the immunosuppressant coverage from the House Bill will pass through to the final bill and in the process the House's oral drug pay for will be replaced by the Senate's oral drug GAO study. That would be a great outcome.

The Congressional Budget Office thinks that adding oral drugs to the bundle will save money - $100 million over 10 years - but I can now say, after evaluating the idea in the context of commenting on the PPS, I'm confident that isn't true. Providing Medicare Part B beneficiaries medically appropriate, universal access to these oral drugs would come at a cost not reflected in current use and therefor current reimbursement. You can't save money you're not spending.

I hope that "other areas determined appropriate by the Comptroller General" will include evaluation of specific examples, from categories of current Part B beneficiaries (e.g. those with drug coverage through work, those with drug coverage through a retirement plan, those with drug coverage through low income plans, those without any drug coverage) to determine how the proposal would impact each group. How would adding binders to the bundle change their access to these drugs?

The Comptroller General should conduct case studies of current Part B beneficiaries with drug coverage under Part D to evaluate the appropriateness of their current use. I believe such an analysis would reveal that current coverage inappropriately limits the use of these effective and important medications. Current Part D copays and the “donut hole” have a profound impact on beneficiary's behavior. Evaluating future reimbursement based on current usage understates the need because under today's reimbursement nephrologists working closely with their patients will forgo prescribing medically appropriate drugs due to their financial cost and the patient's lack of adequate insurance coverage.

I didn't know all that two months ago, but after hours and hours spent thinking about and discussing the idea with scores of people I now have a well informed opinion. I adapted those last two paragraphs directly from the comment I filed last Tuesday. CMS did the dialysis community a great favor by including oral drug under the PPS. There is no way, as a community, we CKD advocates could have come to understand the implications of the seemingly simple idea of adding "specified oral drugs" to Medicare's dialysis treatment payment. We now know that the problems are much deeper than the questions of logistics specified for study under Section 10336.

Thanks to CMS's PPS oral drug trial balloon the entire CKD advocacy community can enumerate numerous challenges that arise from paying for binders and calcimimetics through Part B. From Congress's point of view the big problem will be it doesn't save money. Unless ... the CBO evaluates their inclusion assuming the drug prices are directly negotiated by Medicare. Nothing bars Medicare from negotiating Part B drugs directly with pharmaceutical companies. And that approach might end up saving money, even while expanding access and improving care.

Best PPS comment, nonDialyzor catergory

By Bill Peckham

No new PPS comments were posted today (you can view the comments here or download the continuously updated Excel file), but I am expecting at least a few more. I haven't seen one from KCC or from FMC, I expect they'll be posted early next week.

So far I have 1,115 comment on my PPS spreadsheet. They run the gamut from the actionable to those that can be summarily dismissed. I'll have a more in depth analysis once I think all the comments are posted. There were a lot of great comments from dialyzors. Dialyzors using the NxStage are vastly over represented. I can't wait to count up the comments from people using the NxStage (and NxStage family members). I think home dialyzors really came through to improve this rule for everyone. If CMS really listens to their beneficiaries they'll get rid of medical justification and pay fairly for home training.

I'll compile and post from the best dialyzor comments soon, until then here is my favorite comment out of all that were submitted, in the non-dialyzor category.

It's the 1,112^th comment I read. Maybe I'm just loopy from all the previous multipage entries, but I thought this one broke through in an engaging way, to tell a story that made the author's point, in fewer than 2,000 characters. (The submission was through the website interface so it was limited to 2,000 characters (the web interface also strips paragraph breaks, I've made a guess where to add them to improve the comment's readability.)):

I will never forget the first time a dialysis patient was upset with me. It was 15 years ago. I was an undergraduate Dietetic Student at the University of Vermont. I was interviewing dialysis pts on their calcium/phosphorus intake. One Saturday morning 2 pts absolutely refused to participate.

I had interviewed each of them 15 times before, but today, interviews were not going to happen. Why? The pts refused, saying; "we're trapped here in a chair. we're prisoners. We're going to sit here for 4-5 hours on a Saturday, and then spend most of our weekend trying to recover. You're going to ask a bunch of questions and then run off to enjoy your day. We don't want to help you".

What they were really saying is that they wanted to be free. They wanted to recover faster and feel better. They wanted a more "normal life". Why do i remember these 2 pts? Having now worked with many home hemodialysis pts, I know that these 2 pts should NOT have been in that center, not these 2.

They should have been treating at home, they should have been enjoying the benefits of daily home hemodialysis. Clinical evidence tells us that pts performing more frequent, home hemodialysis, realize faster recovery times post-treatment, a reduction in BP meds, increased levels of energy, less depressive symptoms, improved mental and physical capabilities, etc...

I applaud CMS for including in the proposed rule a stated goal of encouraging more home dialysis, and for allowing providers the opportunity to bill for more frequent therapy, which has been proven to improve the lives of patients. Unfortunately, because the stated rule fails to appropriately capture the costs associated with providing the essential HHD training required for home patients, I fear you are working against your stated goal.

Please reconsider the elimination of separate payments for home hemodialysis training. You are so close to hitting the mark, improving cost of care and quality of life. Help keep pts home and free.

That's a great comment. If you're the renal dietitian from CA congratulations, you won the best comment nonDialyzor award.

In your honor I went through and corrected the spelling of "Dietitian" in Column P across all 19 page of the spreadsheet.

My comments to CMS on the ESRD Prospective Payment System Proposed Rule

By Bill Peckham

My comment on CMS's proposed payment rule is now submitted. You have until 5PM Eastern Wednesday December 16th to get your comments submitted. This has been a challenging process. Exhausting.

Over 850 comments have been posted (you can view the comments here or download the continuously updated Excel file). The comments run the gamut from unactionable complaints about MIPPA to the 126 page opus submitted by the Kidney Care Partners (PDF link). After reading the KCP comments I would be shocked if oral drugs make it into the final rule. CMS seems to have clearly misread MIPPA to find statutory authority to include oral drugs. You get what you pay for and the KCP comments must have cost a lot of money to produce: they are very good, very compelling.

Reading through all the public comments reveals a deep distrust among all parties involved in the provision of dialysis. Patients don't trust providers who don't trust physicians and the feelings are mutual. And Medicare? Well Medicare doesn't trust us and we don't trust them, times ten. Sigh.

I don't know where this lack of trust will lead. Maybe somewhere on the other side of this seismic change is a reimbursement system that controls cost by promoting optimal dialysis. I think that is possible but it will take a concerted effort.

I don't think it is within the power of humankind to devise an optimal payment system for dialysis in one massive effort. Success will mean revisiting the questions raised by the PPS again and again; ongoing evaluation and improvement should be a routine feature of the payment system. This is an historic change that will guide and constrain the provision of dialysis for a generation. It's critical to get this right.

My over 4,000 word comment follows:

What makes a great comment to Medicare? One that is thoughtful and actionable.

By Bill Peckham

By my count 584 comments have been submitted to Medicare in response to the ESRD Prospective Payment System Proposed Rule (you can view the comments here or download the continuously updated Excel file). I've read all the comments; the passion for the dialysis program and patients comes through above all. However, I'm concerned that for all the passion the commenters aren't closing the deal. The comments aren't closing the deal because many are not including an actionable solution.

The number one topic of commenters is the inclusion of oral drugs in the new dialysis payment. There is a lot of passion around not including oral drugs, with many commenters mentioning logistical concerns, patient compliance and inadequate reimbursement as reasons oral drugs should be left out of the bundle and many predict an increased prevalence in secondary hyperparathyroidism as the inevitable consequence of units controlling costs by using inexpensive and less effective drugs. And that is as far as many commenters get.

Without offering Medicare a concrete step they can take to avoid these bad clinical outcomes, without offering a solution, the commenters are leaving it to Medicare to both want to solve the problem and know how to solve the problem. It would make life easy if a chorus of boos was all it took to keep oral drugs out of the bundle but unfortunately the tide is running the other way.

The House of Representatives' health insurance reform bill - HR 3962 - mandates the inclusion of binders and calcimimetics in the dialysis payment bundle. If Congress passes a law that oral drugs are included in the payment then Medicare must follow that mandate. A larger bundle is the direction the world is going; a commenter should acknowledge this reality and then close the deal with an actionable suggestion. In the case of oral drugs the actionable suggestion is: to wait. CMS (and Congress) should wait a few years before adding oral drugs into the bundle.

Wait until dialysis providers have fully implemented the changes that are mandated by MIPPA. Wait until the fair cost of these relatively new drugs can be accurately judged. Wait until appropriate quality measures are established. Wait so that providers can adjust their operations to accommodate other recent administrative and clinical challenges e.g. CROWNweb, the Conditions for Coverage. Wait until health reform is passed: so that we can understand the implications for the donut hole and the cost of drug access under the new law. If CMS takes that action, if CMS waited ... that would be a good outcome. I don't think "no oral drugs ever in the bundle" is on the table; a prudent delay would make this rule better.

Waiting isn't never. Given time Medicare will be able to evaluate other options to calculate the average cost of these dialysis specific oral drugs and then add a fair amount to the base payment rate. The methodology used in the proposed rule spreads the binder and calcimimetic 2007 Medicare reimbursement costs (largely Part D spending) across all patients. 2007 is not an appropriate base year, and what to do about those who are Part B primary but have drug coverage outside of Part D?

Action: Medicare should wait and establish the base year after healthcare reform increases access to these dialysis related oral drugs and once the average cost per well managed beneficiary is known.

To talk about this post or any issues related to Medicare's proposed rule to expand the payment bundle, register and join the conversation at Kidney Public Policy 101.

Expanded Dialysis Bundle Will Increase Administrative Costs

By Peter Laird, MD

MIPPA legislation in 2008 mandated an expanded bundled payment system for Medicare dialysis patients. In doing so, the proposed rule will rely upon a higher base payment calculated to be about $198 with case mix adjusters to fill in any variations in costs between patients of higher or lower complexity.  At the outset, this system appears to take advantage of social and medical factors that could lead to inequality in care among patients.  However, what CMS has not addressed in any of their comments or discussions are the hidden administrative costs for physician and dialysis providers Medicare compliance.

Under current Medicare laws and regulations, the physician or dialysis provider must comply with all Medicare regulations and offer compliance training to all of their employees.  As a physician who has undergone such compliance training and who has been involved in documentation efforts over many years, the unforeseen implications of the increased complexity of the case mix adjusters with the propose bundle rule will lead to increased time at the point of service for dialysis technicians, nurses, physicians, social workers, pharmacists and dietitians to remain in compliance with each pay per session data collection.

Provider Risks for Fraud & Abuse (PDF link)

• Billing for services/supplies that were not provided
• Incorrectly reporting diagnoses or procedures to maximize payment
• Billing for services/supplies or writing prescriptions for drugs that are not medically necessary
• Remuneration schemes that unlawfully induce or reward the provider to bill for services/supplies or write prescriptions
• Provision of false information (e.g. falsifying info on a prior authorization request, misrepresenting dates of service, etc.)
• Unbundling charges
• Violating the assignment agreement, Fee Schedule, or Maximum Allowable Actual Charge Limits

To accomplish this point of service daily session task, there will need to be intensive training modules likely conducted by outside consultation firms.  In addition, the dialysis providers will need to hire compliance officers to oversee and implement these programs.  This is an additional administrative position and cost not detailed in the CMS bundle rule.  In addition, due to the complexity of case mix adjusters that can change from session to session and must be properly recorded and documented, I cannot perceive any manner in which this could be done accurately with manual input.  In such, I believe that we will see a growth in Medicare Renal Bundle software programs which will also come with payed consultants to implement and oversee the accuracy of Medicare compliance.  With low level trained employees responsible for the majority of data input in dialysis centers, pre-designed templates will be the only way in which the data can be properly collected with point of service computer prompts.

The case mix adjusters also have several key inpatient factors that will need to have close data recall and sharing between inpatient and point of outpatient care parties. This will increase the secretarial administrative duties with the dialysis unit and most likely will be accomplished by added employee positions.

In addition, the physician who wishes to stay in compliance will need to update their training on an annual basis since it is likely that CMS will change the allowed case mix adjusters on a yearly basis as they already to with payable DRGs we see in the inpatient and outpatient settings.  With a fixed rate of payment and no compensation in kind for these hidden administrative costs, the setting is in place for competition of funds between administrative layouts and clinically required treatment costs.  Without upfront costs adjustments for these hidden administrative costs, patient care is at risk of further decline in quality with the likelihood of adverse outcome increases in a population already at the highest risk of adverse outcomes in the western world.

I would suggest a simplified single payment without complex case mix adjusters as many private capitated contracts already do very successfully.  The only winner with increased bundle complexity will be CMS itself which will need to add to their employment ranks to oversee the compliance of such a complex system.  Those at the sharp end of the needle are at great risk of higher rates of complications due to competition between administrative costs and treatment costs.  The current CMS bundle rule should be simplified to reduce and eliminate these new and hidden administrative costs while at the same time complying with the intents of MIPPA.

HR 3962 mandates the inclusion of binders and calcimimetics in the dialysis payment bundle

By Bill

Given all the rending of garments and gnashing of teeth over Medicare's proposal to include oral drugs in the new expanded dialysis payment mandated by Congress, I expected a similar reaction to the ESRD section of the House health insurance reform legislation, H.R. 3962: Affordable Health Care for America Act. Instead, I have seen no reaction at all to the legislative language that would mandate Medicare include oral phosphate binders and calcimimetics in the new per treatment payment for dialysis.

I have heard broad support for the first part of H.R. 3962's ESRD section which would extend immunosuppressant drug coverage to those that would otherwise loose Medicare coverage three years after transplant. That's a long overdue change but does the ying and yang of Washington require every good idea to be balanced by a bad idea? No matter what Medicare decides in response to comments, if the House language stands oral drugs will be in the bundle (link):

(b) Medicare Coverage for ESRD Patients- Section 1881 of such Act is further amended--

(1) in subsection (b)(14)(B)(iii), by inserting ‘, including oral drugs that are not the oral equivalent of an intravenous drug (such as oral phosphate binders and calcimimetics),’ after ‘other drugs and biologicals’;

(2) in subsection (b)(14)(E)(ii)--

(A) in the first sentence--

(i) by striking ‘a one-time election to be excluded from the phase-in’ and inserting ‘an election, with respect to 2011, 2012, or 2013, to be excluded from the phase-in (or the remainder of the phase-in)’; and
(ii) by adding before the period at the end the following: ‘for such year and for each subsequent year during the phase-in described in clause (i)’; and

(B) in the second sentence--

(i) by striking ‘January 1, 2011’ and inserting ‘the first date of such year’; and
(ii) by inserting ‘and at a time’ after ‘form and manner’; and

Including oral medications in the bundle is represented as a way to pay for immunosuppressant drugs but that doesn't make sense.

To include binders in the bundle Medicare would take all the money spent on binders through Part D, divide by the number of treatments and add that amount to the base payment rate (after figuring the impact of case mix adjusters). In other words it is a budget neutral process. The problem with this is that if the payment was fair then it wouldn't be budget neutral (let alone save money).

This provision would cost money because many people who are Medicare primary for Part B services have their binders paid for by a private insurer outside of Medicare Part D. Since under this provision they would have their binders supplied by the unit and reimbursed through the per treatment payment - you have to ask where is that money suppose to come from? Either Medicare would have to reimburse more or it is an unfunded mandate that will result in more hospitalizations and worse outcomes.

I'm all for immunosuppressant drug coverage but including oral drugs in this ham handed way is bad for dialysis patients, without any obvious benefit to Medicare or taxpayers. Hopefully the Senate can propose a sensible alternative.

Medicare's proposed reimbursement rule matters; your input is needed

By Bill Peckham

There are now over 300 comments to the proposed rule to implement a new prospective payment system for facilities that provide dialysis services to Medicare beneficiaries (PDF link (183 pages)). There have not been very many comments by dialyzors, only about half a dozen commenters have identified themselves as current or former dialyzors. I hope that number will grow.

Yesterday I participated in the first Northwest Kidney Centers forum on the payment bundle. I would have liked it to have been standing room only (there were 17 or so) but I understand that my level of interest is unusual. Having a meeting on the details of Medicare's dialysis reimbursement policy is a tough sell. Really to understand how complicated dialysis reimbursement is try explaining it in ten minutes. I was asked to the effect "Why should I care about this?".

It's a good question. I answered that it matters. The details of the proposed rule matter and I think the rule can be improved. I made the point that Medicare would very much like to hear from their beneficiaries and those who love us. That this is an historic opportunity to improve how dialysis is provided and that we'll be living with the consequences of this rule for many years. Even if you never need dialysis or never need dialysis again, by taking time now to read about and understand this rule you can improve dialysis for the people who will. And I believe you, you who understand, have an obligation.

It'll take some time; it'll take some effort but it's not a long term commitment. You only have until December 16th (Medicare just announced that the deadline has been pushed back a month). If you don't understand how this rule might impact dialysis then go to the Renal Support Network's Kidney Public Policy 101 discussion board and/or the Northwest Kidney Centers Medicare Bundling Proposal page. When you are ready to comment read the NKC guidance Give Input to Medicare and make yourself heard. For all the comments that have been made a lot still needs to be said.

ESRD PPS Public Comments Available as Excel File or Web Page

By Bill Peckham

So far nearly 300 comments have been made in response to the ESRD Prospective Payment System Proposed Rule. The comment period goes through November 16th. If you are ready to comment submit them here. If you don't understand how this rule might impact dialysis then go to the Renal Support Network's Kidney Public Policy 101 and/or the Northwest Kidney Centers Medicare Bundling Proposal page.

The public comments to Medicare are being collected, characterized and published by DSEN through Google documents in order to understand what is being said and what is being missed:

The above spread sheet is available to view on its own html page, or you can download the file as an Excel file. The comments are in the process of being characterized as speaking to Home Hemo Training; Amount of Payment; Labs; Oral Drugs; QIP; Case Mix Adjustment; Race Adjuster; Method II; Small Volume Facility; IV Meds; Blood Transfusions; CoPays and Identity of Commenter. Categorizing the comments is an going process; as comments are added and characterized the spreadsheet and links will be updated. (Notice that Google documents limits their spreadsheets to about 100 rows, as a result the comments are on three separate sheets of about 100 comments each. In order to sort the comments by what category has been checked you should download the Excel file, combine all sheets into one and then sort).

The majority of the comments express concern about including oral drugs in the bundle and while many commenters do not identify their connection to dialysis it does seem that dialyzors are vastly underrepresented. If you'd like to help characterize the emails or have any feedback drop me an email or comment. Now is the time to get up to speed, Medicare wants your feedback on the proposed change.

Northwest Kidney Centers dialysis payment forums this week

By Bill Peckham

The Northwest kidney centers has an excellent bundling resource page on their website as part of their effort to engage patients and the rest of the community in the dialysis payment rule making process. In addition  NKC is putting on three forums:

NKC will hold forums for patients about proposed new rules for Medicare dialysis coverage. Enjoy kidney-healthy snacks and get answers to your questions. Speakers will be CEO and president Joyce F. Jackson and emeritus trustee Bill Peckham, who's been on dialysis for 19 years. No need to RSVP, but let us know if you have questions. Contact Janice McGee, 206-292-2771, ext. 1120, or Janice@nwkidney.org

I wouldn't say we'll be speaking, so much as leading the conversation.

The available written materials are very good (e.g NKC's explaination, MEI's explanation (PDF link)) but I think these face to face meetings are a great opportunity to get up to speed. There are going to be three:

• Tuesday, Nov. 3 – 3 to 4:30 p.m. at the Bellevue Library
• Saturday, Nov. 7 – 2 to 4 p.m. at Haviland Pavilion (downtown Seattle)
• Sunday, Nov. 8 – 2 to 4 p.m. at SeaTac Pavilion (across from airport)

These are open to anyone who is interested. Come on down and talk to us about how dialysis is paid for and the changes that have been proposed. Medicare wants your input, find out what you need to know.

Turk's comments on behalf of NxStage at the CMS Town Hall meeting

By Bill Peckham

The recording of the CMS Town Hall meeting on ESRD Prospective Payment System Proposed Rule is available until Thursday October 29th. RenalWEB has linked to some of the comments that have been made available; what follows is the outline Joe Turk spoke from on behalf of NxStage:

Good morning

• And thank you for this opportunity to comment on behalf of my colleagues and partners.
•  Since 2005 at NxStage Medical, we’ve been providing hemodialysis devices designed for the home that have at least partially enabled a modest rebirth of home hemodialysis in the United States.
• In my comments, I’ll focus on access to home HD and how the proposed rule addresses home HD training. I’ll echo on some comments previously made, and hopefully expand on these as well.

In our review of the proposed rule…

• The Agency’s desire to encourage home dialysis comes out loud and clear, and we applaud this. Many proposed policies are quite supportive of home HD, namely the treatment as the unit of payment, medical justification provisions for more frequent dialysis sessions, and the addressing issues with separately billable injectables in the home.
• However, we have serious concerns about how home HD training is addressed in the proposed rule
• We feel that inclusion of training into the base bundle is inappropriate because of training’s investment significance and non-routine nature, and feel that home HD training should be handled with an adjustor.

So first, training represents a significant, essential investment by the dialysis provider.

• Home patient training is a necessity, not an option. Training transforms a patient from a health care novice to an expert in his or her own care. Without resources and provider investment, patients cannot go home.
• Our data representing thousands of patient experiences over multiple years show that home HD training requirements average 5 days per week for 3 to 4 weeks, representing 100 hours or more of 1:1 RN time per patient.
• The Moran Company also analyzed Medicare cost report data for home HD training. This study found average costs of $394 per training session, approximately $250 more per session than the base composite rate. This amount is consistent with the reported labor requirements of training.
• So, home HD training is far from a trivial expense for the provider. It also differs in scale and scope than that of PD. Home HD and peritoneal dialysis are very different animals, and I caution anyone from applying generalizations of what we know about PD to home HD. We cannot assume it directly applies.

Second, training is clearly a non-routine activity

• Only 15% of centers offer home HD therapy today. At even these centers, only a subset of their patients are trained each year.
• Training sessions represent only a tiny fraction of one percent of total treatments.
• Paying for training in the bundle compensates clinics who are not even offering home modalities, while taking funds away from those that are.
• As such, inclusion of training costs into the bundle will not provide encouragement to pursue home HD training activity given the large up-front investment per patient; in fact, the reverse will be true.

Third, we believe that training should be addressed through an adjustor, but importantly the first 4 months adjustor does not adequately achieve this objective

• In the proposed rule, adjusters are applied for select high cost service episodes or situations, and training is in concept similar
• In fact, it is noted in the proposed rule that the first four month adjustor is intended in part to support home HD training. Practically, however, this is not the case. Based upon third party analysis of a large cohort of patients initiating home HD therapy over recent years, only 15% were in the first 4 months of therapy. This adjuster applies only to a small minority.

In summary

• We are at an exciting juncture, where home HD could finally become a practical reality for more than 1% of patients and part of the fabric of kidney care.
• But, we can’t forget home HD therapy remains in its infancy and is vulnerable, and is different from established PD and HD options in this regard. Payment policies will either support ongoing maturation or could inadvertently stall or reverse access.
• Again, NxStage is pleased that the proposed bundle is largely supportive of home HD therapy, but believes home HD training must be addressed differently if providers are to invest in the resources necessary to build and maintain home HD programs. This is a real gap today, as Bill Peckham mentioned.
• We urge CMS to address home HD training using the adjustor construct and to use the best available data to create an appropriate payment amount.

THANK YOU AGAIN FOR THIS OPPORTUNITY TO COMMENT

I certainly second Turk's remarks, it is inappropriate to include home training in the base payment rate.

The change CMS is proposing to the way dialysis is reimbursed is an historic, one time opportunity. After the proposed rule goes into effect it will be much harder to make a change. This is what happened in 1983 when the first composite payment came into effect - when that rule was proposed a mechanism to update the payment to accommodate inflation was not included. It's taken over 25 years to fix that by getting a law passed by Congress and signed by the President! I do not want to spend the next 25 years lobbying Congress for a training rate that has some relationship to training costs.

I think it is clear that without a training rate significantly greater than the base rate access to home dialysis, particularly home hemodialysis will be limited. 25 years from now no one wants to look back and see access to healthier forms of dialysis limited to certain zip codes. All Medicare beneficiaries should have the access I do to clinically superior frequent dialysis in the home.

Turk is right that we are at "an exciting juncture", a proverbial fork in the road. Down one path lies the penny-wise policy of paying for home training at the same rate as routine incenter dialysis. This path dwindles as it disappears over the horizon because fewer and fewer dialyzors are offered this healthy route. The other path is the one CMS should develop, the path of adequately reimbursed home dialysis training. Looking towards the horizon this path grows over time as home dialysis training capacity increases. As the census of dialyzors at home grows so too will grow the number of dialyzors living the lives they were meant to live but for their CKD.

CMS should take this historic, one time opportunity to set us on the path to optimal dialysis, CMS should adequately reimburse for home dialysis training.

Medicare shouldn't use race/ethnicity as a case mix adjuster

By Bill Peckham

When CMS published the proposed new dialysis payment model they did not use race or ethnicity as a payment adjuster but they did request comments on the idea (page 46 of large PDF):

We specifically invite public comment on the data issues presented in this section, other data sources for race and ethnicity we should consider, and specifically, the need for adjustments for race and ethnicity in the final ESRD PPS.

I think CMS was right to not include race as an adjuster.

Race is not a biologic concept, it is a social concept. And as a social concept it has been judged by the Supreme Court to deserve condemnation:

Over the years, this Court has consistently repudiated "[d]istinctions between citizens solely because of their ancestry" as being "odious to a free people whose institutions are founded upon the doctrine of equality." Hirabayashi v. United States, 320 U.S. 81, 100 (1943)

To contravene the doctrine of equality and include a case mix adjustment for race there would have to be a biologic basis for the various racial classifications. There is no biological basis for racial categories. A person's classification is commonly based on self-reported information. Self reported information is problematic, particularly with regard to racial/ethnic classifications.

Who is considered Hispanic? Who is Hispanic is a social, or mental construct that varies from community to community, however, checking that box would have serious consequences if you need dialysis. Under the two data sources CMS evaluated, REMIS/CMS Form 2728 and the Medicare Enrollment Database, those self identified as Hispanic would be reimbursed less, 14.2% and 16.3% respectively, then some who self identifies as white. It would be wrong to reimburse someone's dialysis less based on their identifying with a particular community.

The Kidney Care Council, DaVita and the American Kidney Fund (AKF) spoke in favor of including a race/ethnicity adjuster to the new expanded dialysis payment rate during their comments at CMS's Town Hall meeting Friday (Uremic Frost has posted the AKF's remarks). The AKF noted studies that report African Americans require higher doses of EPO to maintain a their hemoglobin in the target range. Their phrasing points up the problem. How are they using the term African American - what is their definition? Does it include those from the Caribbean? First generation immigrants from Africa? From South Asia?

Medicare was right to not include race/ethnicity adjusters in the proposed dialysis payment model. In general I believe, in the name of simplifying the payment model, that there should be fewer patient level case mix adjusters and that those that are used should be based on underlying clinical conditions.

Mend the Gap - Schatell's comments to CMS and the renal community

By Bill Peckham

I liked a lot Dori Schatell's remarks during the CMS Town Hall meeting on the ESRD Prospective Payment System Proposed Rule. Schatell is the Executive Director of the Medical Education Institute, which is probably best known for its troika of dialyzor centered websites: Home Dialysis Central, Kidney School and Life Options. Less know is the role Schatell has played online with MEI's discussion boards and also with the Dialysis_Support listserv where she has patiently answered questions for 13 years. Schatell is a tireless advocate for optimal dialysis through dialyzor education and involvement in their own care.

The dialyzor is central to MEI's evaluation of CMS policy. MEI has published a draft of their written comments to CMS on the proposed rule (PDF link). They are very good, very thorough. When given the opportunity to speak at the town hall rather than present a summary of these written comments MEI took the opportunity to address the entire renal community about a topic dear to my advocacy heart. As a strategy that was a great idea.

Here are the Medical Education Institute's comments Schatell presented to the CMS Town Hall Meeting 10/23/09:

Thank you for the opportunity to speak, and for all of the countless hours you must have put in compiling this proposed bundled.  I’m sure it wasn’t fun.  Like many others today, we agree with the concerns that have been expressed about including oral medications and lab tests, the overall complexity of the bundle, and the impact of both on patient co-pays.  But that’s not where I’ll be addressing my remarks today.

At the Medical Education Institute, we don’t work day-in and day-out in dialysis centers.  So, that gives us the luxury to step back and observe the renal community from a bit of a distance.  We take a long-term, strategic view.  And one observation that we’ve made is that it’s very important to periodically challenge our assumptions.  They are not gospel.  

For example, the case-mix adjustment is based on completely unvalidated 2728 data—which means we are building a structure that can affect patient care on top of a house of cards.  We strongly recommend that those data be validated—that a sample of them each year be checked for accuracy.  Maybe you’ll find that they’re 100% accurate.  But I don’t think so.

We also need to challenge the assumption that it’s okay to do dialysis just three times per week.  We were very pleased to see that CMS included the possibility of more frequent hemodialysis treatments in the proposed bundle, with medical justification—but I think you need to go one step further, and eliminate medical justification.  Here’s why.  Each year in the U.S., about 110,000 people start dialysis—and about 87,000 people die, a rate that has only improved by about 2% over the past decade, and which is worse than any other industrialized nation.  

Now, you might think that all of those deaths are evenly distributed among the seven days of the week.  And, for peritoneal dialysis, they are.  But for standard hemodialysis, that’s not true:  Bleyer’s studies, compiled from USRDS data, found that the risk of death, of sudden cardiac death, is 50% higher than expected on the day after the 2-day dialysis weekend.  And, in fact, it’s three times higher—triple—in the 12 hours before the next treatment after that 2-day gap.  In a keynote address at the Annual Dialysis Conference last February, Dr. Carl Kjellstrand, a nephrologist from the Netherlands, estimated that more than 10,000 dialysis deaths per year in the U.S.—10,500—could be attributed solely to what he calls the 2-day “killer gap.”  

Kathe LeBeau said, “If we get this wrong, patients pay with their lives.”  I would argue that they already have.

We don’t close ICU’s on Sundays.  We don’t give insulin to diabetics just three days per week.  We don’t use heart-lung machines three times per week.  It makes no physiological sense to replace a continuous body function with an intermittent therapy.  If any practice in U.S. nephrology requires medical justification, it should be short, three times per week dialysis treatments!

Perhaps you noticed that all of the patients who spoke today were getting home dialysis, or had a transplant.  At the Medical Education Institute, our mission is to help people with chronic disease learn to manage and improve their lives, and our goal is to create expert patients who can self-manage at a high level.  The best way to do that is to have more home dialysis.  So, it is vital to not threaten more frequent dialysis by rewarding clinics that don’t train and punishing the minority who do. 

You have an opportunity to improve dialysis patient care.  I hope you’ll take it.

To adapt a phrase from London's subway - Mend the Gap.

The 2 day "killer gap" underlies the entire proposed rule - the payment is based on 13 payments a month, so it was an apt topic to bring up but more important than bringing these points to Medicare's attention was bringing these points to the renal community's attention. I'm not sure CMS's reimbursement is the barrier to every other day dialysis, so much as it is dialysis providers that have shown no appetite to challenge the status quo. (note that this is a world wide phenomenon. Every other day incenter dialysis is not offered anywhere in Europe or Oz either, AFAIK).

The Town Hall was a unique opportunity to talk to the whole renal community - Schatell made the most of it. Mend the Gap.

Berkowitz comments to the CMS Town Hall meeting on ESRD Prospective Payment System Proposed Rule

By Rich Berkowitz

I was so very glad I was chosen to be a speaker by CMS for the Town Hall Meeting.  I'm sure everybody else who asked to speak had comments just as important as ours, and I'm sorry not everybody had a chance to speak.

But I want to remind all that your written comments will be just as important as ours were today.  In fact, more important since ours were not to be seen as testimony, but just remarks.  We, too, have to send in our written comments.  So let's please get serious in the coming days before November 15th.

Here are my remarks:

I’m Rich Berkowitz, the founder of NxStageUsers, the largest independent group of dialysis patients using the NxStage home hemo machine.  I’m also on the NxStage User Advisory Panel.

Dialysis can be said to be akin to the storyline of The Lord of the Rings – at every turn lurks potential danger.  Unless you’ve experienced it, you have no real idea, and numbers alone don’t tell the story.

I’ve been on dialysis since February, 2003.  The first three years I dialyzed in-center and since then at home.  I’ve experienced four modalities: in-center conventional and nocturnal, and home short daily and nocturnal.  Home dialysis has saved my life.  For many, in-center is an increasingly debilitating experience, and I can be proof that conventional dialysis is certainly not “adequate”.  At least it wasn’t for me.  Even though my labs were always within acceptable range I suffered a heart attack driving home from one of my dialysis treatments.  The symptoms began over the long weekend.

When I started home dialysis, I went through an intensive period of training.  There were initial problems once at home that would have probably been avoided if I had another week’s worth of training.  In fact, I ended up hospitalized unnecessarily.  I later learned my training was limited to three weeks because the dialysis manager was concerned about how much it was costing her department.  That’s what happened when $20 was reimbursed for the training session when a nurse gets paid about $50 per hour.  So my concern is not that training is to be included in the bundle, but that the allotted dollars have been insufficient in the first place.

One reason mentioned for the first four month 47.3% adjuster is the cost of initial home training.  But the fact is approximately 85% initially start with in-center hemodialysis.  Therefore, those funds will not be available for home training use for most patients.  For that reason I would first like to see training remain outside the bundle and increased in its reimbursement, or alternatively have an accommodation made for more realistic training costs to be covered inside the bundle, such as an additional adjuster.  Although I’m an existing home dialyzor, I’m concerned about new home patients getting the necessary training to successfully transfer home.  It can also affect current dialyzors if their center has less incentive to continue its program.

Another great concern for home dialyzors – actually all dialyzors - is the inclusion of all dialysis meds.  I don’t think I have to tell you how difficult or expensive it is for many dialysis patients to get Medigap insurance.  Including all meds affects and discriminates against those who already have Part “D”.  Also, patients, especially home dialyzors, may pay more out-of-pocket because they will be responsible for the 20% Medicare doesn’t cover, whether or not they use or need the meds.  Another concern is whether providers will be able or willing to make available the most effective meds, which tend to be newer, and non-formulary.  Regarding labs, the proposal is too broad in that it doesn’t define ESRD related labs, but allows all tests ordered by the MCP physician to be included in the bundle.

I want to speak briefly on the Quality Incentive Program.  Adequate is such an ambiguous term.  It has a different meaning to each person. To me, adequate dialysis connotes to be just enough.  But just enough for what?  Just enough to stay alive?  Instead of adequate, the emphasis should be to optimize treatments.  Make the treatments to allow people to lead more healthful and purposeful lives.  Keeping them alive just to have another treatment is simply not enough.

Longer and more frequent treatments have proven to be more effective in optimizing outcomes.  Therefore, whatever measure is chosen for the QIP, it needs to be applicable and adjusted for the treatment regimen.  Home dialysis should not be inadvertently disincentivized – it is the superior treatment.  In the future, I would recommend tracking, iron management, bone mineral metabolism, phosphorus and vascular access.  Please consider hospitalizations, fluid overload, cardiovascular health, and overall survivability.  Please allow the dialyzor’s quality of life to be the best it can.  Thank you.

Recording of CMS PPS Proposed Rule Town Hall available for four days

By Bill Peckham

I found the Town Hall very informative. There were 24 speakers (PDF link) in addition to brief opening remarks from a couple CMS officials. CMS will make audio of the town hall available for just four days:

A recorded audio version of the Town Hall meeting will also be available Monday, October 26, 2009 beginning at 9:00 AM through Thursday, October 29, 2009 at 11:59 PM (Eastern Daylight Time) by dialing 1-800-642-1687, conference ID number 33239635.

Audio from the Open Door Forum is going to be available for a month. The Town Hall was more informative, its audio should be available at least until the proposed rule comment period closes.