Dialysis from the sharp end of the needle

Offering an EOD schedule is the best response to patients skipping treatments

By Bill Peckham

At the risk of becoming The Bruce Dikinson of the dialysis industry, when I read the JASN abstract that connects skipping dialysis with URRs below 65%, and thus a 1% payment withhold under the QIP, I think the only prescription is more cowbell! dialysis! Offering Every Other Day (EOD) schedules is the best response to control the cost of skipping.

The JASN paper only addresses the costs associated with being subject to a 1% withhold under the QIP, this understates the cost to the unit of skipping.

Think of a person who comes every treatment, who dialyzes 156 times a year, who we'll call G ... compared to someone who tends to skip twice a month and at the end of the year has dialyzed 130 times, who we'll call D.

First, one reason a person may skip regularly is that they don't feel very well when they do dialyze three times a week; if you're going to feel unwell if you do or you do not go to dialysis, you'll be more likely to not go. EOD schedules, when followed, would increase the person's chance to feel well, thus their ability and willingness to accommodate regular dialysis. But we're talking money, skipping and costs.

On the cost front, consider G's financial impact. Each dialysis payment under the expanded bundle is made up of fractional payments. Lab tests are in the bundle; each one of G's 156 reimbursements include some amount intended to cover lab tests. If G dialyzes 13 times in the month it means that the unit received 13 fractional payments intended to cover the cost of labs.

In addition with each payment the center received fractional payments to cover other monthly services and fractional payments for services that are delivered quarterly or yearly. All sorts of services required by the Conditions for Coverage are paid for a little at a time out of each individual, treatment, reimbursement e.g. the cost of care planning, iron, social worker support, PTH tests, Hepatitis tests, nutritionist support are all paid for a little at a time, by each treatment even though they don't necessarily happen each treatment.

Now consider D's financial impact. Labs still need to be done each month but at the end of the month there are only 11 fractional payments available to pay the cost of running the tests. D, just through skipping, generates 16% less revenue to pay for services delivered at frequencies less than each treatment.

The biggest financial effect may be D's EPO profile before and after skipping. In general let's assume D will need the same yearly dose of EPO whether dialyzing 156 times a year or 130, D will need 624,000 units of EPO (likely D would need a higher yearly dose due to skipping). If D runs 156 times the EPO dose will be 4,000 units per treatment. If D runs 130 times the EPO dose will need to be 4,800 units per treatment. D's skipping makes each treatment less lucrative, over and above any QIP withhold.

EOD schedules fix the financial side of this problem. Skipping in and of itself is a clinical problem, and as the JASN authors note there are as many reasons for skipping as the mind can imagine. But skipping shouldn't mean not having access to dialysis and units shouldn't be trapped into a needless financial drain. I don't think D is thinking: I only need to dialyze 11 times this month, more likely, about twice a month, D has a sense that: I need a break.

With an EOD schedule D would receive the 13/month medical minimum number of treatments - enough dialysis to avoid expensive hospitalizations and keep URRs above 65%; the unit would have received the number of payments anticipated by the bundle to pay for formerly separately billable services; and D would have had two breaks during the monthly grind. Win. Win. Win.

D should be given an EOD schedule and expected to call the unit as soon as the intention to skip is known.

Every Other Day (EOD) incenter dialysis schedules can be done (Part I); EOD schedules would improve clinical outcomes and support patient choice (Part II); EOD schedules are implicitly supported by MAC/FIs (Part III); EOD schedules would improve the clinic's finances and may lower overall Medicare costs per person, per year (Part IV); EOD schedules would increase the clinic's value (Part V). And, EOD schedules are a sensible clinical and financial response to patients who routinely skip treatments.

Shareholders should demand patient access to Every Other Day incenter dialysis schedules

By Bill Peckham

This is Part Five, the last in a five part DSEN series making the case that Every Other Day (EOD) incenter dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three); EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

Let me say from the outset that I don't usually spend a lot of time on dialysis industry equity prices and the concerns of shareholders. I own no stock related to the provision of dialysis. However, as Peter's comment today nicely illustrated, the owners of the capital need to be part of the discussion. I think the case that the seventh treatment would be financially lucrative, is strong. But that is not quite the same thing as value. Today's shareholder is most interested in value.

Would EOD schedules increase the clinic's value? Certainly. Shareholders should be EOD schedules' biggest proponents.

It is easy to think that value to a shareholder relies entirely on net income and ultimately it is true an equity share price has to correlate to net income. But it is net income as it is expected for that industry, for that business, for that business at this point in its life cycle. Dialysis as an industry is at the mature stage of its business life cycle. Most of the dialysis in the United States is provided by two large dialysis organizations that are for profit companies with equity shares available to the public and are generally understood to be at the mature stage of their business life cycles. 

Being at the mature stage leads investors to have expectations of what it means to serve X number of patients or operate X number of facilities. This is why changes in insurance reimbursement are such a big deal to the dialysis industry - whether it is regular inflation adjustments to Medicare's payment (+), or two percent cuts to per treatment funding (-), or the new role of the exchanges (+/-?) it's a big deal because it changes the value of the companies. If average reimbursement goes down, for whatever reason, 100,000 patients are not going to be worth what 100,000 patients were worth the day before. In the world of equity traders what a patient is worth ultimately determines what a dialysis provider is worth.

The good news is we're worth quite a bit to these equity traders, over $85,000 a piece if recent sales are our guide (here, here). We're being sold not as people but as dialyzors. Buying/valuing an established dialysis provider would be like buying/valuing an airline. Sure you pay something for the planes but mostly you're paying for the right to the routes and the airline's frequent fliers. The units are the routes and dialyzors are the frequent fliers. To a shareholder the fact that dialyzors, unlike most frequent fliers, are largely captive of their proximate service provider is a feature not a bug. Providing dialysis and being in position to provide dialysis in the future, has equity value.

EOD schedules increase that value. If patients are worth $85,000 dialyzing six days every two weeks, they're worth more dialyzing seven. EOD schedules increase the value of the provider because they increase the expected value of serving a patient. EOD schedules advance shareholder interests.

Providing every other day incenter dialysis schedules would increase the value of the provider.

Do EOD schedules offer financial benefits to Payers and Providers?

By Bill Peckham

This is Part Four of the unheralded five part DSEN series making the case that Every Other Day (EOD) incenter dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three); EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

At their simplest clinic finances are the average reimbursement per treatment vs the average cost per treatment. EOD schedules manifest as one extra treatment every two weeks and compared to the conventional treatments, that treatment would have a higher average per treatment reimbursement and a lower average per treatment cost. 

The seventh treatment, the extra treatment of an EOD schedule, would have higher average reimbursement per patient because use of EOD schedules would skew towards people who drive themselves to dialysis, and as a group, people who drive themselves to dialysis have better insurance than people who rely on funded transportation. 

The seventh treatment would also have lower non-labor costs. Services such as EPO, iron and labs are fully funded after 6 treatments, meaning in effect the seventh treatment would carry a ~$70 premium. This gain would have to be weighed against the wage premium and possible tenant costs associated with opening on Sunday, but the higher average reimbursement and lower non-labor costs suggests EOD schedules would be viable with relatively few patients.

Beyond the straight revenue/cost analysis EOD schedules would be a financial plus if it keeps patients out of the hospital. Dialysis units pay a price when their patients are hospitalized, and they will benefit if EOD schedules keep their patients in their chairs, dialyzing. Thus, it is an important, fundamental question - will EOD schedules keep patients out of the hospital?

The answer is yes. Would the decrease in hospitalization cover the added cost of EOD schedules? I think so but, on reflection (hence the edits to the position statement) I can't make a very solid case. It is not a simple question to answer. The added cost for Medicare of EOD schedules would be about $5,000 (80% allowed $ x 26) per patient per year and there looks to be $5,000 to be saved in hospitalization cost. On average in 2008 (most recent data year) people who use hemodialysis spent 14.5 days in the hospital, at a cost to Medicare north of $30,000. 

However, the people who choose EOD schedules might not have average hospitalization profiles, if they are healthier than average it means there is less hospitalization costs to save. And if EOD schedules improve survival, if EOD schedules extend people's lives, that will increase total Medicare spending.

And, it does give one pause that incenter EOD schedules are provided no where on Earth. All routine incenter schedules include the dialysis weekend, no matter if the dialysis is being provided through a for profit system or a centrally planned, state owned hospital, . You would think that if EOD schedules saved their cost that systems that fully paid for both the dialysis and the hospitalization would offer EOD schedules. They don't, so maybe EOD schedules wouldn't lower total spending (though I am not convinced, groupthink would be an alternative explanation), but even if EOD schedules don't lower total Medicare healthcare spending they should still be offered.

The dialysis weekend represents a cost shift of sorts. Not getting regular dialysis is risky but patients are instructed in how to decrease the risks through strict dietary control. The added dietary restrictions are a cost. The dialysis weekend increases risk and increases the cost of care to the patient. That doesn't sound like a system that is up to our standards. 

EOD schedules would improve the clinic's finances. EOD schedules lower overall Medicare costs EOD schedules may lower the overall Medicare costs per person, per year.

 

Would Medicare routinely reimburse EOD dialysis schedules?

By Bill Peckham

This is Part Three of a five part DSEN series making the case that incenter Every Other Day (EOD) dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three); EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

The question has to be asked - would EOD schedules receive routine reimbursement from Medicare, in the same way that conventional schedules receive routine reimbursement? My review of the documents online leaves me to conclude that Medicare support of EOD schedules is implied though not plainly expressed. It is possible that, short of a National Coverage Decision (that anyone can initiate) it may be necessary to fight for routine EOD dialysis reimbursement but that is a fight worth having and on this ground it is a fight dialysis unit administrators can win. 

Medicare Administrative Contractors (MACs) are entities, created by 2003 legislation, that are contracted to pay claims on behalf of Medicare. The country is divided into 15 regions and each region has a MAC (I think there will eventually be 5 MACs, possibly 10 but it is confusing; current list here (PDF LINK)). When a dialysis unit submits a claim, that claim is submitted to their MAC, who then rejects, or authorizes and pays, the claim.

The Medicare Benefit Policy Manual has little, but not nothing, to say about coverage related to hemodialysis treatment frequency, Chapter 11 - End Stage Renal Disease (ESRD), (PDF LINK):

30.1 - Frequency of Dialysis Sessions
(Rev. 1, 10-01-03) A3-3112.6, A3-3166.2
Hemodialysis and peritoneal dialysis are covered at the frequencies shown below under the composite rate. Additional composite rate payments may be made when they are medically justified.

A) Hemodialysis
The usual pattern of hemodialysis consists of three sessions weekly, and these may be covered routinely. If the ESRD facility bills for any sessions in excess of this frequency, the intermediary shall consider requiring medical justification 

MACs are guided by the Medicare Benefit Policy Manual when making claim decisions. According to the claims manual additional dialysis treatments can be reimbursed when they are medically justified but if additional hemodialysis treatments are provided it is up to the MAC whether medical justification is required.

One way MACs communicate their understanding of what is and is not covered or required for coverage, is through Local Coverage Determinations (LCD). As published in CMS IOM 100-08, Section 13.5.1 (PDF LINK), to be covered under Medicare, a service shall be reasonable and necessary. It is the MACs job to ensure LCDs for the service in question is considered reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. Basically, MACs will consider a service to be reasonable and necessary if the MAC determines that the service is (my emphasis):

• Safe and effective.
• Not experimental or investigational (with exception).
• Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
  • Furnished in a setting appropriate to the patient’s medical needs and condition.
  • Ordered and furnished by qualified personnel.
  • One that meets, but does not exceed, the patient’s medical need.
  • At least as beneficial as an existing and available medically appropriate alternative.

Two of the current MACs have LCDs regarding hemodialysis treatment frequency: First Coast (FL, PR, VI) and Trailblazer (CO, NM, OK, TX). First Choice directs that:

HEMODIALYSIS sessions which exceed the frequency of three sessions per week must be medically reasonable and necessary.

Trailblazer directs that:

Hemodialysis and peritoneal dialysis performed or billed more than three times per week is reasonable and medically necessary for hyperkalemia, pregnancy, fluid overload, acute pericarditis, congestive heart failure, pulmonary edema or severe catabolic state when these conditions are refractory to dialysis three times per week.

The Trailblazer LCD doesn't preclude payment under other circumstances, but it does suggest that payment for four or more treatments in a week would not be routinely granted. But what about three and half treatments a week? 

An EOD schedule (3.5 treatments per week) uniquely meets the directive that duration and frequency of service be "One that meets, but does not exceed, the patient’s medical need."

There is very good research, most recently a NEJM paper, but the data has been consistent since the 1960s: routinely taking two days off from dialysis increases the risk of mortality and hospitalization. The NEJM paper found that the incidence of death increased during two days off from dialysis vs during the remainder of the week when treatment is every other day :

all-cause mortality (22.1 vs. 18.0 deaths per 100 person-years, P<0.001), mortality from cardiac causes (10.2 vs. 7.5, P<0.001), infection-related mortality (2.5 vs. 2.1, P=0.007), mortality from cardiac arrest (1.3 vs. 1.0, P=0.004), mortality from myocardial infarction (6.3 vs. 4.4, P<0.001), and admissions for myocardial infarction (6.3 vs. 3.9, P<0.001), congestive heart failure (29.9 vs. 16.9, P<0.001), stroke (4.7 vs. 3.1, P<0.001), dysrhythmia (20.9 vs. 11.0, P<0.001), and any cardiovascular event (44.2 vs. 19.7, P<0.001).

In order to meet a patient's need, in order to have 18.0 deaths per 100 person-years, instead of 22.1, patients have to adhere to an EOD schedule. Dialysis on an EOD schedule is reasonable and necessary.

EOD schedules are implicitly supported by MAC/FIs.

EOD schedules would improve clinical outcomes, and support patient choice

By Bill Peckham

This is Part Two of a five part DSEN series making the case that Every Other Day (EOD) incenter dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three) EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

I haven't seen, compared to a conventional schedule, the clinical benefits of an EOD schedule disputed. That the dialysis weekend is risky is well known. Most recently a NEJM paper reviewed the evidence but the data has been consistent since the 1960s. Routinely avoiding the weekend should routinely lead to better clinical outcomes.

The tougher questions to answer are concerns that patients would not want to switch from conventional three day a week schedules to EOD schedules, that patients prefer three day a week schedules.

Unless there is a choice it can not be said that there is a preference. For patients who want to dialyze incenter there is little access to higher frequency dialysis. Incenter patients do not have agency to decide their dialysis frequency. I believe that if there was a choice and the risks that are inherent in the dialysis weekend were well understood a significant number of patients would choose the safer schedule.

Some patients due to transportation issues would not be able to use an EOD schedule. Some patients would prefer the set weekly schedule allowed by conventional three day a week dialysis. Some patients seeing EOD schedules as requiring more from them would feel like they are doing all they can and they just aren't able, at this time, to do any more. This is all to be expected and accommodated.

However, some number of patients would want to use the safer schedule and would choose to dialyze EOD. How many is not a number I can give. Each patient would have to make their own personal cost benefit analysis but I think there is reason to believe that most patients would reckon EOD schedules to be a good value.

We're not use to thinking in terms of weekly dose of dialysis, let alone the biweekly dose of dialysis, but I think we should. Talking about treatment duration alone obscures dangerous anomalies like the dialysis weekend. One way to quantify the impact of the weekly dose of dialysis is the HemoDialysis Product (HDP). The HDP assigns an impact value to various weekly dialysis schedules (D&T just republished the Scribner classic) using a simple formula: HDP = (hrs/dialysis session) x (sessions/wk)².

My experience supports using HDP as a way to understand the impact of various schedules; how various schedule would make me feel as compared to other schedule options. In order to decide if I would use an EOD schedule I would want to weigh the benefits against the cost. Would I feel better, would the burden of CKD5 be less vs. spending more time dialyzing and taking into account the net effect of additional time getting to and from the clinic and the time spent recovering from the dialysis treatment. The costs are easier to reckon then the benefits, the HDP provides a way to quantify the expected benefits.

A conventional three day a week, four hours per treatment schedule has a HDP=36; keeping treatment length the same but dialyzing once more every two weeks, i.e. going to an EOD schedule, brings the HDP up to 49. Thus, increasing the amount of time dialyzing by 16.6% - from 6 days every two weeks to seven days evey two weeks - will increase the impact of therapy by over 36% - from 36 to 49.

Another way to say it is that going from 12 to 14 hours of treatment per week, in effect, in this way, through frequency, increases the HDP 13 points. If instead you increased your weekly time to 14 hours while keeping frequency the same, i.e. doing four hour forty minute runs three times a week, your HDP would be 41.94, a six point gain.  Frequency gives more dialysis 'bang' for a dialyzor's 'buck', paid in time.

The EOD schedule is the better value. There is every reason to believe that if EOD schedules were offered, EOD schedules would be a popular choice.

Think of the very good financial advise to pay your mortgage every two weeks instead of every month. If you pay every month you will make the 12 payments and four times during the year you get an extra week of income between payments. Having an extra paycheck between mortgage payments is pretty great. But if you pay every two weeks you end up taking years off of your mortgage, saving lots of money and you don't really notice that you made a 13th monthly payment during the year. An EOD schedule would be like agreeing to pay your mortgage every two weeks instead of every month. It's the smart move.

Offering EOD schedules improves clinical outcomes. Offering EOD schedules supports patient choice.

The Every Other Day Dialysis Clinic

By Bill Peckham

My contribution to the excellent discussion taking place on The Kidney Doctor (spring boarding off the Atlantic article) puts forward incenter every other day dialysis schedules as one of the solutions needed to improve the clinical outcomes of those who use dialysis. I am an advocate for incenter every other day dialysis (e.g. the petition, here, here), I have not heard anyone dispute that this would be better clinically but some might question this, the push back I have heard has been that it is impractical. Not that it shouldn't be done, but that it can't be done. Or it can only be done at too high a financial cost. 

I say that Every Other Day (EOD) incenter dialysis schedules can be done (Part One); EOD schedules would improve clinical outcomes and support patient choice (Part Two); EOD schedules are implicitly supported by MAC/FIs (Part Three); EOD schedules would improve the clinic's finances and [edit; equivocation] may lower overall Medicare costs [edit] per person, per year (Part Four); EOD schedules would increase the clinic's value (Part Five).

I will make my case in five parts. Part I -

EOD incenter dialysis schedules can be done along side conventional schedules

The most specific concern that I have read is that you couldn't do EOD dialysis schedules for some patients but not others. "You can't be a little bit pregnant" the skeptics remind, contending that a unit would have to go entirely to an EOD schedule to offer anyone an EOD schedule. "They'd have to be 100% in or 100% out", "What clinic can accommodate its entire pt population for an additional treatment day?".

I would not advocate switching entire incenter populations over to EOD schedules but I think all patients should be offered EOD schedules. Transportation to the unit, specifically funded transportation, is an issue outside the control of units and represents a real barrier to EOD schedule access. I don't see EOD schedules being used by a majority of patients but I do believe it would be a popular choice if it was widely available.

What follows is an example of how a unit could operate with some patients using an EOD schedule, while other patients, the majority of patients continue to use a conventional three day a week schedule.

Consider a 24 station unit - operating six shifts Monday through Saturday at 80% capacity, a unit with 115 patients dialyzing 3x/week on average for 3.5 hours.

The unit would have to have in mind the minimum number of patients they would need to have dialyzing on Sunday to open the unit (the unit conventionally runs Mon to Sat). And then double that number to find how many patients the unit would need to start EOD schedules. It's a question of staffing.

Staffing a Sunday shift would be more costly than an average conventional shift but the treatments provided would carry more reimbursement. There would be different staffing requirements for different units, depending on case mix among other factors. For ours the number is 12, the unit would need 12 patients to make opening the unit on Sunday viable. Thus, the unit needs 24 patients to want EOD schedules for it to make sense to start their EOD program.

36 patients have agreed to switch to EOD schedules (there will need to be another post on how it might come to pass that a third of a unit's census would agree to switch but it would start with buy in from the patient's MCP physicians).

The first step to make this work is to divide the EODers into two groups of 18 (a number well over the 12 patient threshold). Instead of calling them MWF and TTS we'll call them Group 1 (G1) and Group 2 (G2). At this unit the interest in EOD skewed to the evening shift.

To accommodate the EODer's shift preferences the unit manager has to have 8 stations on the evening shift (16 wanted EOD) and 5 stations on both the morning and mid day shifts (10 patients on each wanted EOD schedules). As the EOD census grows or contracts G1 and G2 have to stay in balance, just as the shifts generally have to remain in balance. However, unlike MWF & TTS, G1 & G2 are indistinguishable from the dialyzor's point of view so switching between the groups should not represent a problem but it will mean that there will be times when patients have to shift from G1 to G2 or vise versa - as long as the number of patients on G1 and G2 is greater than 24 (12+12) the program remains viable at this unit.

Day One
It's Monday and G1's turn to dialyze. The patients get themselves to treatment and arrive at their appointed times, receiving their treatments normally. If they use ESAs they receive their dose. This continues through the day. From an operational stand point it should look like any other Monday even as this tectonic shift in the provision of dialysis is taking place.

Day Two
G2 comes in for their dialysis. As with G1 this looks like any other Tuesday from an operational stand point. Unless you looked at their charts you wouldn't be able to tell G2 patients from the conventional TTS patients. But as a group they do skew towards the units younger and healthier patients. Many of the unit's older and sicker patients rely on funded transportation to get to and from dialysis and it has not yet been worked out how to make funded transportation compatible with EOD schedules. This reality does mean that as a group the EODers are younger, healthier and have better insurance than the unit's patients generally.

Day Three to Six
The unit would continue to operate per usual, without any unique staffing requirements. In gathering supplies and preparing stations, staff would know they were getting ready for Wednesday and G1 or Thursday and G2. If it was time for labs they'd be drawn, iron would be given, visits with doctors and staff, nutritionists and social workers would take place normally.

Day Seven
On Sunday G1 would come in for dialysis. From the patient's point of view Sundays would be different. On every other day of the week you'd come in at your normal time but if dialysis fell on a Sunday you'd come in, most likely, at a different time. Having a special Sunday time for dialysis, different from dialysis on conventional days, is what allows EOD schedules to embed in a unit with a majority of patients using conventional schedules. 

It might be that on Sunday G1 and G2's dialysis is always during a window from 8AM to 2PM or it could be that G1's Sunday is from 10AM to 6PM and G2's is from 8AM to 2PM. The options would need to be evaluated based on patient and staff preferences and availability but ultimately most patients would need to accommodate a time outside their conventional time. Until the EOD census grows it will be necessary to operate the unit for just part of the day on Sunday. Additionally by operating the unit for only six or eight hours the unit would still be available for maintenance tasks typically done during off hours.

It's 10AM, G1 arrives in waves of four, 20 minutes apart. The four techs and one nurse get 18 patients dialyzing by noon. At the height of operation the unit operates 18 stations at once with a slightly higher staff/patient ratio then their conventional standard, since no medications, labs or ongoing education is taking place and there are no deliveries and few phone calls. The patients have event free treatments, they are generally healthier than the average unit patient and they have not had two days off. Note that no formerly separately billable services are provided on Sunday but payment is the same, resulting in the ~$70 included in the bundle for formerly separately billable services to be available for increased staffing costs.

Day Eight
G2 comes in for dialysis. From an operational perspective it should look the same, setting up treatments based on a patient's prescription. Staff would know to set up for Monday and G2. The only difference I would expect to be apparent is that G2 would not show the effects of taking two days off while the conventional Monday patients would continue to show the symptoms associated with the break in their routine renal replacement.

Day Nine to thirteen
Lather, rinse, repeat.

Incenter every other day dialysis can be done along side conventional dialysis schedules.

My comment to CMS on the proposed 2012 QIP for ESRD

By Bill Peckham

The deadline to submit comments on: Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule is, I think, past not up, there is still time! Regulation.gov site indicates you have to 11:59PM EDT August 30. http://www.regulations.gov/#!submitComment;D=CMS-2011-0129-0002

As with my past public comments (here, here, here) I post them:

Re: CMS-1577-P: Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014: Proposed Rule

Dear Administrator Berwick:

Thank you for the opportunity to comment on the proposed changes to the End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014 (QIP). My name is Bill Peckham. I have been a Medicare beneficiary since 1988 and have used dialysis since 1990. My comment primarily concerns the proposal concerning anemia, so I note that I have used ESA therapy in the past though for the last  ten or so years with diminished frequency and as of today it has been nearly four years since my last dose; today I have a normal red blood cell count and thus do not, at this time, use ESA therapy.

I work as a sign maker, through the union, in the tradeshow and hospitality industry. I volunteer in various ways to promote the optimal health, quality of life and independence of people who use dialysis. I volunteer both with my provider, Northwest Kidney Centers, where I am immediate past trustee board chair and continue to serve in many ways, locally with the Kidney Research Institute, on the KRI Council, and nationally on the oversight committee of a federally sponsored comparative effectiveness research project, with DOPPS, on their steering committee and I volunteered to serve on the recent C-TEP looking for fluid management CPMs last year. Through my blog, Dialysis from the Sharp End of the Needle and participation in the CKD online community I've made many connections with people involved with the provision of dialysis, on both ends of the needle, and have had many discussions, over many years, about the details of Medicare reimbursement policy for those with severe kidney disease. The reimbursement details of CMS's ESRD program is my hobby; one I take seriously.

The dialysis community is still digesting the changes that have come with the bundle. The data I have seen through DOPPS and the reports I have heard through email and online communities, is that ESA use has declined since the final rule was announced a year ago. And that this has resulted in generally lower hemoglobins, which the effected dialyzors report, limits their energy and thus diminishes their quality of life.

Given this developing trend it is a particularly risky time to make the changes proposed in CMS-1577-P. Specifically, the proposal to eliminate the performance measure (CPM) "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)" will magnify this trend to the detriment of your beneficiary's quality of life. 

A close reading of the FDA label change suggests that a Hgb=10 is a valid treatment threshold (link: http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm ):

• For patients with CKD on dialysis:Initiate ESA treatment when the hemoglobin level is less than 10 g/dL.If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA.

This guidance suggests that a threshold of 10 g/dL is appropriate and complies with MIPPA's language that “measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management”.

I propose that CMS continue the QIP's support of the FDA label's treatment threshold of Hgb=10 for payment year 2013 and 2014. 

However, to improve the QIP and allow for care that is tailored for each beneficiary the QIP should move away from both the Hgb=10 and the Hgb=12 CPMs, to an anemia CPM that reinforces best practices and gives your beneficiaries a voice in their anemia management.  

I propose that CMS institute a new QIP CPM:  "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target hemoglobin for that beneficiary" (%+/-Hgb Target).

In this year's final QIP final rule, CMS should propose using 2012 outcomes of a %+/-Hgb Target CPM as a benchmark to implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgment into practice. The NQF did not evaluate anemia CPMs based on the MCP physician prescription but I believe the Secretary has the discretion to take this approach under the exception clause of MIPPA Sec 153(c)(2)(A)(i). 

I like this approach because the beneficiary can be included in the discussion as to where to set their personal Hgb target allowing the MCP physician to take their patient's view on the trade offs between a Hgb=11 vs a Hgb=9 into consideration when setting an individualized goal. Basing the goal on the MCP physician's judgment allows individualization in the framework of existing rules. Requiring MCP physicians to set and monitor the target should not be a burden since it is very nearly what is required today. This could be implemented by 2012.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement to note ESA Route of Administration. Starting this January providers will be required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012. Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it would be a simple math equation to determine the unit's performance.

This approach to the anemia question would help to reinforce the role of the MCP physician as the medical professional in charge of the individual treatment details of each of your beneficiaries who use dialysis. The dialysis unit is being paid to implement a care plan that they jointly develop with the patient and the doctor, the proposed CPM would reinforce these separate roles. 

Taking this approach forward the MCP physician's prescription could form the benchmark for other CPMs from the dialysis unit to the hospital. Meaningful CPMs related to bone health and Kt/v are very difficult to develop if they are meant to apply to every person using dialysis. I think a better approach would be CPMs based on the MCP physician's prescription for each beneficiary. The beneficiary's personal calcium, PTH, Kt/v and phosphorus targets would make useful CPMs. By showing confidence in the judgment of the doctors you employ to manage our care the QIP can implement CPMs that have much more meaning to the lives of your beneficiaries.

Sincerely,
Bill Peckham
Seattle WA

It may be that this time I veered too far to the quixotic and my comment doesn't fully meet my goal to offer thoughtful and actionable feedback. My focus these days is more on work, less on hobbies; it's hard to stay up to speed.

The QIP should establish a new CPM: Hgb +/- 10% of MCP Physician target

By Bill Peckham

The Centers for Medicare and Medicaid Services (CMS) has a public comment period open right now for you to comment on proposed changes to CMS's ESRD Quality Incentive Program (QIP) that was mandated by Section 153c of H.R. 6331: Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

The most important proposed change from last year's QIP rule (PDF link) is the elimination of the Clinical Performance Measure (CPM): "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)". I supported the below Hgb=10 penalty in my 2010 comments because I felt that the inherent nature of the bundle would put a tremendous downward pressure on the use of the class of ESRD anemia correcting medications called, Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp.

This proposed elimination comes in light of the FDA's new lable which recommends:

• For patients with CKD, consider starting ESA treatment when the hemoglobin level is less than 10 g/dL. This advice does not define how far below 10 g/dL is appropriate for an individual to initiate. This advice also does not recommend that the goal is to achieve a hemoglobin of 10 g/dL or a hemoglobin above 10 g/dL. Individualize dosing and use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions. Adjust dosing as appropriate. 

The drug label previously recommended that ESAs should be dosed to achieve and maintain hemoglobin levels within the target range of 10 to 12 g/dL in CKD patients. This target concept has been removed from the label.

In order to put the QIP in concert with the label change (as required by Section 153(c) of MIPPA) CMS proposes to use just two measures for the 2013 QIP penalties (based on 2011 outcomes) Hgb >12 and URR <65%. The proposed rule also includes a payment update of 1.8% (the first in the program's history that did not require a specific Act of Congress) and eight future measures (2012 performance; 2014 payment):

• Dialysis adequacy, as measured through the Kt/V method, which is widely recognized as a more accurate measure of whether dialysis cleanses blood effectively
• Anemia management, as measured by the rate of patients with a hemoglobin level greater than 12 grams per deciliter;
• Percent of patients receiving treatment through an arteriovenous fistula – a type of vascular access used to connect patients’ bloodstreams to dialysis equipment for cleansing;
• Rates of infection of the vascular access sites;
• Ratios of hospitalization rates among dialysis clinic patients;
• Whether the facility reports certain dialysis-related infections to the Centers for Disease Control & Prevention;
• Whether the facility administers a patient experience of care survey; and
• Whether the facility monitors phosphorus and calcium levels on a monthly basis.

Comments are due by end of business Monday.

In my comment I will propose that CMS stop including any Hgb numbers in its QIP and instead stake half of the QIP penalty (1% of unit reimbursement) on a new CPM: "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target hemoglobin for that beneficiary".

In their final rule, CMS should propose using 2012 outcomes as a benchmark and implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgement into practice.

I like this approach because the dialyzor can be included in the discussion to set the target and the doctor can take the dialyzor's view on the trade off between a Hgb of 11 v a Hgb of 9 into consideration when setting an individualized goal.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement to note ESA Route of Administration. Starting in 2012 units are required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012 (PDF link). Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it is a simple math equation to determine if the unit's performance was within 10% of the target.

The other concern is what will happen between now and when a more appropriate CPM can be implemented in 2013? With their final rule Medicare must send the message that they expect units to provide the care prescribed by the MCP Physician and act with deliberate haste to align the QIP with outcomes that matter to the dialyzed and enable CMS to meet the intent of the MIPPA (Section 153c): to motivate the safe achievement of optimal outcomes.

Wall Street Journal spotlights home dialysis options

By Bill Peckham

Wall Street Journal Health Journal columnist Melinda Beck has an upbeat article available online, A Dialysis Treatment For The Busy Patient. The article reports on home dialysis, peritoneal dialysis (PD) and home hemodialysis (HHD), and gives a fair assessment of the current situation.  I'm quoted, along with friends of DSEN MEI's Dori Schatell and Northwest Kidney Centers' CEO Joyce Jackson, and several other dialyzors and MDs. 

It's a pretty complicated topic to cover within the confines of a news story, even harder covering both PD and HHD in the same article. While both are home modalities, they really are very different. The modalities are different with regard to the new bundle and they have different clinical advantages. Though I was glad to see mention of one clinical advantage they share:

experts worry that getting dialysis at a center makes patients more complacent about their treatment, and less careful with their health.

This is the learned dependence that is the bane of incenter dialysis.

Also confusing is that some of the details in the article don't apply to both modalities - for instance the need for a helper - and some of the info is not true for the featured devices. The NxStage System One and all PD cyclers can run on a normal 110 circuit. It's only the standard hemodialysis machines (the type used incenter) that need dedicated power.

From a financial point of view (it is the WSJ) the world does get complicated when it comes to the financial incentives and it would have been hard to adequately cover them in the space available (it's hard to explain in the nearly unlimited space of this blog). One complication is that the new PPS promotes both types of home dialysis but in different ways. The medically justified additional payments aren't available for those doing PD, and it is unlikely (though it does happen) for a person to start HHD in the first 120 day of starting dialysis.

Still considering the interest level of a typical WSJ reader and the space constraints, it's a great article.

My comment to CMS on the proposed QIP for ESRD

By Bill Peckham

CMS published the Dialysis Quality Incentive Program proposed rule in July. Comments are due by 5PM (EDT) Friday September 24th. Comments can be submitted electronically through regualtions.gov

I found it hard to get what I am thinking down on paper (I blame a virus that has laid me low for the last four days), but during the Open Door Forum on Tuesday CMS did say they anticipate there will be a rule making process next year when they have to come up with how the QIP will work in 2013.

If you don't have time to read the entire 77 page rule (PDF link), there is a CMS Fact Sheet and DSEN's review. I encourage everyone to offer their thoughts to CMS. The recent experience with the bundle comment process demonstrated that CMS does read and respond to every comment, and that CMS takes comments from their beneficiaries very seriously. What follows is my comment as submitted:

Dr. Donald Berwick
Administrator
Centers for Medicare and Medicaid Services

RE: Proposed Quality Improvement Program for ESRD (CMS-2010-2019)

Dear Administrator Berwick:

I live with stage 5 chronic kidney disease (CKD5), and have been a Medicare beneficiary under the ESRD entitlement since 1988 when I had a preemptive transplant (I was 24 at the time; 47 today). My underlying condition - FSGS - recurred after just 26 months. Thus, since September 1990 I have treated my kidney disease with hemodialysis (HD). Initially I used conventionally incenter HD but for the last nine years, since September 2001, I have enjoyed using a healthier, more frequent dose of HD in the comfort of my home.

I have served CMS as a technical expert, most recently on the Fluid Weight Management C-TEP (Baltimore, March 2010) and previously on the Dialysis Facility Compare TEP (Baltimore, December 2005). My expertise is due to my personal experience using dialysis and my volunteer and advocacy activities over many years.

I currently volunteer as an Emeritus Trustee and Senior Council for the nonprofit Northwest Kidney Centers, having previously served as a trustee (1997-2009) and board chair (2007-2009). I continue to serve on various Northwest Kidney Centers committees and on the board of Northwest Kidney Centers Foundation. I helped to found the Kidney Research Institute (a partnership between Northwest Kidney Centers and University of Washington School of Medicine) where I serve on the Council. I am a Dialysis Outcomes and Practice Patterns Study (DOPPS) Steering Committee member and a member of the DOPPS Patient Centered Care and Quality of Life task force. I recently joined the AHRQ DEcIDE ESRD Expert Stakeholder Advisory Group of Johns Hopkins DEcIDE Comparative Effectiveness in ESRD Study.

And lastly, through my non-commercial, informational blog, Dialysis from the Sharp End of the Needle (www.BillPeckham.com) I track renal industry news and trends, in advocacy, reimbursement, politics and the provision of dialysis. I do my kidney related activities as a volunteer (though some activities provide honorariums), my paid work is through the carpenter's union, where I am a journeyman tradeshow specialist.

As a home hemodialysis advocate I have joined a QIP comment submitted by the Home Hemodialysis Workgroup but I understand that for the most part the QIP is not about people who dialyze at home. The people who will most benefit from an ideal QIP are the 90+% of ESRD beneficiaries who use conventional incenter dialysis. The following comments are offered with people who use incenter dialysis in mind.

I want to offer constructive and actionable comments on the proposed QIP but I have to say I found the proposed End-Stage Renal Disease Quality Incentive Program uninspiring. I don't think a Total Performance Score comprised of the three proposed measures gives a meaningful insight into the quality of care at a dialysis unit. However, given the constraints of the process I think what you have proposed makes sense for 2012, thus these comment are directed more on how to use the QIP in future years.

I am inspired by your request on page 47 of the proposed rule:

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.

I would change that just a little. I believe that if, Medicare ESRD beneficiaries engaged in meaningful conversations with their community of clinicians about the quality of THEIR kidney dialysis care then, THEIR care would improve and the sum of individual improvement would be program wide improvements. That is a worthy goal for the QIP. Unfortunately, I don't think the proposed Total Performance Score will motivate this discussion.

In offering comments the temptation is to expand the Total Performance Score with additional measures. As you note in the proposed rule there are many candidates but I would advise against this strategy. I believe that each additional measure will decrease the impact of the withhold. I propose to maximize the impact of the withhold; I recommend focusing the withhold on a single measure – Hgb under 10. And in turn I would report only Hgb under 10 on the certificate.

The nature of the recently expanded dialysis payment bundle (PPS) creates a strong financial incentive to under-use EPO. Given this incentive there is no need to include a greater than 12 Hgb measure as a component of the financial incentive potion of the QIP. And given the nature of urea there is no compelling reason to use a URR greater than 65% measure as a component of the financial incentive potion of the QIP. Urea is of some value because it is inexpensive and easy to measure but it is a poor marker of quality dialysis. I think urea based measures and Hgb over 12 can play a role in a beneficiary based reporting element of the QIP but should not be used to determine the QIP's financial withhold.

If the financial incentive potion of the QIP is meant to penalize inappropriate cost cutting by dialysis providers in response to the new PPS, and I believe it is, then the withhold should be focused on the area widely identified as ripe for trouble. The financial incentive portion of the QIP should be focused on the under use of EPO, with under use, as defined by the FDA label, being evidenced by a Hgb less than 10. Focusing the financial incentive potion of the QIP on Hgb less than 10 is appropriate. The QIP's withhold of 2%, when applied to the new average case mix adjusted bundled reimbursement, amounts to $5 per treatment, significantly less than the ~$8 the Office of the Inspector General recently reported as the provider's approximate purchase cost of a unit of EPO (1000mcu).

By focusing both the withhold and the certificate on Hgb <10 the QIP will maximize its impact on one area of care solely under the control of the dialysis provider. By focusing on Hgb <10 the certificate would be able to convey a clearly understood result to patients: CMS believes its reimbursement rate is enough to maintain your Hgb above 10; this is how this unit preformed … The combination of a financial stick and public shame offers the best chance to keep providers from inappropriately cutting costs by an inappropriate under use of EPO.

However, quality dialysis is more than a properly maintained Hgb and the unit's efforts at anemia management, no matter what the result, is unlikely to spark a meaningful conversation between those who dialyze and those who care about and for us.

I believe a reporting regime that provides beneficiaries with their own timely, data rich report card, would improve the quality of dialysis and thereby improve Medicare's ESRD beneficiary quality of life by motivating the meaningful discussion you rightly seek. However, to do this, the reporting element of the QIP should develop Clinical Performance Measures (CPM) that are in addition to the CPM that puts reimbursement at risk.

The QIP should present beneficiary results in the context of the unit's results (and the state, network, nation) and in the context of guidance set forth via TEPs and National Quality forums. I think that this change, allowing a CPM to inform the QIP reports to beneficiaries rather than using a CPM to put reimbursement at risk, would be liberating to those working on formulating measures. It would allow more aggressive guidance to encourage optimal dialysis. Using the CPMs to inform guidance to beneficiaries would allow for TEPs to set benchmarks for optimal dialysis, rather than setting measures at the threshold of adequate.

The QIP should report to beneficiaries their results e.g. hospitalizations, infections, UFR (ml/kg/hr), measures of bone health, and their KTV and Hgb, in the context of the unit's results (and the state, network, nation) and against CMS guidance. With this information beneficiaries would be prepared to engage in a meaningful conversation with their community of clinicians. Reporting back to beneficiaries would also be a check on data e.g. hospitalizations, infections, patients could confirm data that may not be fully captured by current systems.

Ultimately the QIP should measure and report the illness burden experienced by a beneficiary. Over time the ESRD program has developed a cost shift of sorts. The disease burden has increased for beneficiaries as shorter treatment times require tighter dietary control and more recovery time; as higher staffing ratios require less time for education and personalized care; and as expectations decline resulting in less rehabilitation, and fewer beneficiaries feeling well enough to work or otherwise lead the lives they were meant to live but for their bum kidneys. A well designed QIP could push back on this trend by letting beneficiaries know if their illness burden is greater than what should be expected. Reporting results in this way would allow beneficiaries to compare their experience with their peers. To be truly meaningful and actionable to beneficiaries, the QIP should seek to report a Total Illness Burden for the beneficiary rather than a Total Performance Score for the unit.

In addition to the QIP CMS could quickly communicate unit performance on many meaningful measures by making public the Dialysis Facility Reports each unit receives, each year. It is a mistake to believe beneficiaries are helped by shielding them from the actual DFR data. The data can be explained and put into context by the many patient service organizations but it is insulting to think that CMS chooses to keep the actual data from their beneficiaries because it is “too complicated “ or will “upset people to know the facts”. Treat your beneficiaries as adults and they will act like adults. Give them information to inform the discussions we all want.

I encourage CMS to use the QIP to engage beneficiaries in their care. Use the statistical communication resources that produce the USRDS Annual Dialysis Report or the yearly Dialysis Facility Reports to present the data. Do not dumb the data down. It may be that the measures will evolve to suggest a single score with meaning, but until then treat your beneficiaries as the adults they are and error on the side of complexity. I believe the community can learn to use sophisticated measures and to understand that for each individual the measures have to be viewed in the context of a complicated disease process. We'll learn, challenge us with our real data.

Submit your comment now.

Under the bundle why can't home dialyzors self administer iron and Vitamin D?

By Bill Peckham

Before MIPPA was passed, when bundling was talked about as a concept, one of the benefits of an expanded bundle was imagined to be that people using home hemodialysis (HHD) would be able to self administer neccessary injectable drugs, besides EPO:

One point always offered in defense of expanding the bundle is that it will increase the dialysis provider's flexibility in providing care ... I currently have to go incenter to receive iron and I cannot receive IV activated vitamin D at home only due to reimbursement rules. Under a bundle I assume that I would be able to avoid the trip incenter to get iron. Whether I would receive IV Active Vitamin D (calcitrol - Rocaltrol (Roche), Zemplar (Abbott)) or continue to receive Active Vitamin D in pill form 

would now be up to my physician. Post bundle, reimbursement would be neutral as to the form of my activated vitamin D. Or so I thought.

On page 150-151 of CMS-1418-F 151 the ESRD PPS (900+ page PDF) there is this comment and response (my emphasis):

Comment: Some commenters suggested that CMS allow for self-administration of injectable ESRD-related drugs at home by home dialysis patients. The commenters indicated that home dialysis patients would prefer to self-administer all injectable ESRD-related drugs at home to include EPO, rather than traveling to the dialysis facility to receive the injectable drugs. The commenters reasoned that since injectable drugs such as EPO, Vitamin D, and IV iron are included in the ESRD PPS bundle, patients should have the option to self-administer these drugs at home. 

Response: Under section 1861(s)(2)(O) of the Act, selfadministration of erythropoietin (EPO)is permitted for dialysis patients who are competent to use such drug without medical or other supervision with regard to the administration of such drug. If a dialysis patient meets this requirement, then he or she can self-administer erythropoietin at home. Payment for erythropoietin and supplies needed to self-administer the drug would be included in the ESRD PPS payment. The ESRD PPS does not fundamentally alter how other injectable drugs are administered under Part B. Thus, under CMS-1418-F 151 the ESRD PPS, home dialysis patients would continue to go to the dialysis facility for the administration of other injectable drugs.

Really?

I've always assumed that the rule limiting HHD reimbursement, and thereby access, to injectable Vitamin D and iron was an inadvertent quirk of the payment system. I've always assumed it was just something that came with doing home dialysis in an incenter dialysis world. This response suggests otherwise. This response suggests that CMS was purposeful in excluding those using HHD under the previous reimbursement rules and plans to continue the practice.

I can't think of a reason for CMS to take this position. I would think that under the expanded bundle this practice of medicine - which drug, in what form, where it is administered, by whom - should be left up to the provider working with nephrologists. It may be that providers and docs will decide that iron should be administered during clinic visits or that an oral version of vitamin D is best, but why is CMS taking a position?

Free Webinar: How Will the New Dialysis Payment Bundle Impact Dialysis?

By Bill Peckham

On August 25th Nephrology News & Issues is presenting a free webinar on the bundle; it should not be missed if you have any interest in CMS's new payment system for dialysis. The new bundle goes into effect January 2011 - in less than five months! 

Start planning for January by attending the webinar:

Unbundling the bundle:
The impact of payment reform on the renal community

On July 26, the Centers for Medicare & Medicaid Services released the final rule on its new payment model for dialysis services. The 1,000+ page report details the major changes in how patient care will be reimbursed, starting Jan. 1. In this one-hour webinar, we will help break down the complexity of the new payment bundle and offer commentary from industry representatives on how it will impact the provider community and patients. 

Date and Time:  Wednesday, August 25, 3 pm EDT 

Introduction: (Basic tenets of the bundle)
     Mark E. Neumann, executive editor,
          Nephrology News & Issues

How will providers respond?: 
     Larry Emerson, administrator,
          Dialysis Centers of Lincoln (Neb.)
     Mahesh Krishnan, MD, MPH,
          vice president of Clinical Research,
          DaVita Inc. 

Will the bundle stimulate more interest in home therapies?
     Joyce Jackson, CEO,
          Northwest Kidney Centers
     James Sloand, MD, Senior Medical Director,
          North American Renal Division,
          Baxter Healthcare, Inc.

The QIP: will it pay off with better outcomes?
     Jay Wish, MD,
          University Hospitals of Cleveland

Registration is easy - in less than five minutes I had a confirmation response email. REGISTER NOW for the August 25th webinar (3PM EDT).

After you register, check out NN&Is article on the Rand Corporation study of financial incentives. Good information to keep in mind as we prepare comments on CMS's proposed QIP.

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.