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

By Bill Peckham

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

Good morning

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

In our review of the proposed rule…

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

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

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

Second, training is clearly a non-routine activity

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

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

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

In summary

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

THANK YOU AGAIN FOR THIS OPPORTUNITY TO COMMENT

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

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

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

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

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

Comments

[Peter Laird, MD]

As many have correctly pointed out, the current format for the bundle has the potential of placing adverse incentives against home dialysis as well as the potential difficulties of having the oral medications included in the bundle.

Another issue that I have not yet seen addressed is the the effects that the complexity of the bundle will have on administrative costs to comply with the bundle and avoid allegations of Medicare fraud for simple mistakes. Many for profit dialysis companies already utilize a bundled payment for their provision of dialysis. For instance, the unit that I dialyzed at for over 2 years had a joint agreement between Kaiser and FMC where a single "bundled" payment of $238 covered all aspects of dialysis care with excellent outcomes. For 2008, the mortality level fell to 7% from the initial level of 20% when the unit opened seven years earlier.

I would propose simplifying the bundle to a contracted rate in the same manner that the private sector already employs. The complexity of case mix adjustors and the many other aspects of the bundle will likely add to the cost of dialysis care simply complying with the rules intricacies.