Oral drugs focus of comments to CMS but many other areas of the proposed dialysis payment rule deserve scrutiny

By Bill Peckham

CMS is posting comments to the proposed rule to expand the dialysis payment bundle. As of Thursday night there have been about 52 comments. The majority of the comments - about 40 of the 52 - are exclusively concerned with including oral medications in the expanded payment and of these all come down against the idea. I agree that including oral medications was the most surprising part of the proposed rule and their inclusion is hugely problematic, however, it is not the only problem.

So far commenters have not mentioned labs. CMS intends for all labs ordered by the patient's nephrologist (defined as the doc that receives the monthly capitated physician payment: the MCP physician) to be covered under the bundle. This creates a number of problems because people have labs unrelated to dialysis done through the dialysis unit. Under this proposed rule patients will need to go outside their nephrologist's care to have second blood draws for routine coumadin tests, blood tests related to transplant, blood tests related to treatment for cancer, etc.. Second blood draws are always a bad idea for people on dialysis. We need to preserve our veins for future fistulas so it's best practice to have the blood drawn during treatment to the extent possible, the proposed rule will prevent this best practice.

Another related way this rule will prevent best medical practices is by preventing lab testing outside of the dialysis center. Under the proposed rule if I show up at an appointment with my MCP physician with a symptom that requires a blood test, I will have to see a second doctor to have the test paid for by Medicare. That could result in a dangerous delay in care. That is not a best practice. This proposed rule will likely prevent my nephrologist from acting as my primary care physician. That is a big change to the way I manage my healthcare and I don't think it is a change for the best, it will add cost and complexity to my care.

Travel. Patient travel must be defended against this proposed rule. When I travel and need to dialyze incenter the unit I am traveling to, almost always requires lab tests that would not otherwise be needed. Who is suppose to pay for these? That's not all. My travel will cost my home unit money even if they do not pay for the added lab testing. My home unit will not receive some of the reimbursement for things they provide monthly/quarterly/yearly - fractional payments for these periodic services are in the new bundled  payment for each treatment. The unit I visit will get the fractional payments due my home unit. I don't think it is my interest, for my travel, to cost my dialysis provider money.

On the other side of equation what will happen when I get to the unit at my destination? Will I get all of my medications? What happens if I don't get my epo? This sometimes happens today when the unit can bill separately for the epo they administer. Today if I don't get my epo, they don't get paid. What happens under the new bundle? What recourse do I have if my epo is withheld during a week long visit away from my home unit? Travel shouldn't require that I compromise the quality of my dialysis.

I understand that I am free to comment and I will, but if the comments so far reflect, broadly speaking, the thinking of the dialysis community then a lot is being missed. Even more than I hit on here ... pediatrics, the small facilities definition, increased patient copays, access to home dialysis, and more. The Kidney Public Policy 101 message board created by the Renal Support Network is a great resource (it's not just for patients but patients should feel particularly welcome). Everyone connected with dialysis should be checking out and using the forum to sort through this complex legislation that will change how dialysis is provided in the US; most particularly people with CKD should involve themselves in this historic process.

Changing how oral drugs are reimbursed is a big deal but this proposed rule change is full of big deals. It all deserves comment.

Comments

[roberta mikles]

Bill, I, too, was surprised as I read through the 52 comments and noted content. Even some had almost exact wording. I urge and have been telling all about the kidneypublicpolicy101.com as it is a terrific resource that has been made available. Also, Mark Neumann making available Homeward Bound. Yes, p.o. meds are important, indeed. However, all must remember that this proposed rule can affect their life. I fully understand the reasons for this rule, however, our group also has many concerns because as we know, in the past, meds e.g. Epo were not administered in the best interest of the patient (of course not all facilities). However, will this rule possibly impede further the correct dosage of med (other and all) administration because of these meds being included? Hopefully NOT because of the connection to anemia management outcomes/reimbursement. But, if facilities are not making the profit-margins that they desire, will this be put first before the well-being of the patient when it comes to ordering medications? Labs need to be addressed also and all must understand the importance of a physician being able to order a lab when needed without feeling restricted in doing so. Many patients require additional labs, perhaps weekly. Hopefully, medical justification will suffice in some respect if the patient does not meet CMS criteria. Many units order extra supplies for patients e.g. coban if tape can't be used post dialysis, etc. If units stop this many patients might not be able to afford such. Home dialysis training and other areas also need to be recognized. There are just so many other areas, in addition to oral medications, that need to be addressed. I hope that people realize that and play the devil's advocate when reading through the rule because this can, in reality, in our group's opinion, affect the patient and not positively in every respect.
Roberta Mikles, RN,
Advocates4QualitySafePatientCare
www.qualitysafepatientcare.com

[bill chramer]

have there been any comments on its effect on home dialysis (PD or HB) yet? in my mind, this is one of the most important issues with the bundled rate so i'm somewhat surprised oral meds have been the focus.

[Zach]

This is what the proposed bundle rules say about drugs and travel (pg. 363):

"In addition, we would expect that ESRD facilities would coordinate the provision of renal dialysis service drugs on behalf of traveling patients to facilitate ongoing compliance with the plan of care during periods of travel."

[roberta mikles]

This, statement alone,(identified above p 363) leaves alot open to interpretation and decision making on behalf of the providers.

But, We (Advocates4QualitySafeCare) again, are aware of reasons for the bundling, however, WE EXPECT, (and hope) in light of this major change (PPS), that CMS has taken into account the effect, both positive and negative, that patients might experience as a result of this proposed rule.

After reading through the updated comments there still appears to be a major, if not all, focus on oral drugs. Isn't anyone concerned about travel? IV meds? Lab work? Other indicators of quality safe care besides anemia and adequacy?

Roberta Mikles, RN
Advocates4QualitySafeCare
www.qualitysafepatientcare.com

[Bill Peckham]

If fine words on paper was all it took to ensure "compliance with the plan of care" during travel people wouldn't have their epo withheld today.

The lab piece could be addressed by having a menu of routine dialysis related labs covered under the expanded payment and allow the lab to directly bill CMS at 100% for labs preformed outside the list. In that way labs related to travel would be separately billable by the labs even though they have been ordered by the MCP physician.

CMS has a very elaborate Fistula First initiative that is making good progress to increase fistula placement and use. Fistula use is one thing that strongly correlates to survival in the DOPPS data. Fistula First recommend the best practice Save your blood vessels:

You have a limited number of places on your arms and legs where a doctor can create an AV fistula. Take steps to protect those places so you can use them in the future. There are things you can do now to save your access sites and keep your options open.

The most important way to "save your access sites and keep your options open" is to minimize the use of your veins for blood draws. CMS should allow the MCP physician to order non ESRD labs. These labs should be drawn during hemodialysis treatments and the lab should be allowed to bill CMS and be paid 100% - no copay.

One other thing I was stuck by reading the comments is that for the most part they did not offer solutions or advise on how to make including oral meds work. There was some recommendations given - limit oral meds to those with IV equivalents. Even people pointing out the lack of any bone measures in the proposed quality element did not turn that around and offer the advise to include measure x or y if binders are included under the bundle.

Pointing out that bone measures need to be included if binders are in the bundle and then suggesting the measures that would be needed e.g. calcium x phosphorus sum, pth, helps push back against their inclusion but it is also in keeping with the spirit of the enterprise.