Washington. Healthcare. Translated.

DIALYSIS: Above All, Do No Harm

Every few years, a new industry becomes the apparent victim of Medicare’s regulatory wrath. First, the power scooter market, then the eye surgeons, then power scooters again. The latest proposed cuts in ESRD – big cuts, in case the world of dialysis isn’t your regular thing – give some the impression that dialysis clinics are the latest victims. See the July 8, 2013 proposal for ESRD prospective payments here.

I’m not convinced.

Most of all, I’m not convinced the “big cuts” are fatal. Everyone agrees use of expensive ESA drugs has shrunk dramatically. Take out the big and predicted slash in the pharma component of the bundle, and the rest of the drop is far less dramatic.

In any case, the cut in the overall bundle might really be a smokescreen for the bigger issue: who gets to pocket the savings when costs drop? This is quite a battleground.

Medicare (CMS) views the cost savings are theirs, since their own rules helped ratchet down the costs, while natural forces did the rest. In any case, they assume, Medicare should only pay for what’s delivered – always win when costs drop, and always lose when (covered) costs rise.

Dialysis Operators: Friend or Foe at CMS?

On the other side of the battleground, ESRD operators see their own innovation and hard work as the source of savings. They want a chunk to flow through to their shareholders. The debate is a great policy fight, but the dialysis industry probably doesn’t want to be the poster child for that endless war.

Like all ESRD issues, though, complications set in quickly. It appears clinics might have used those earlier drug profits to subsidize other kinds of patient care that deserved coverage in the first place. Staffing with RNs instead of aides. Providing supplemental nutrition (Ensure) to keep patients strong. Stuff we all agree is smart.

(Well, Medicare might not agree that stuff is smart, since CMS can’t pay for non-covered services even if they mean better quality and lower costs. Clinics confessing to cross-subsidies risk criminal penalties and worse. Drat those little statutory prohibitions!)

If it took a little overuse of ESA drugs, or reuse of partial vials, to improve patient care, I’m open to the idea that we merely have a bookkeeping error and not a case demanding a strong federal clawback.

But my skepticism might be looking in the wrong direction this month.

The immediate battleground isn’t industry fighting clawbacks to the Trust Fund.  It’s really the mysterious review process at Medicare as they review public comments to the proposed rule and figure out a Final Rule that saves the trust fund while saving face.

The comment period closed in early September as CMS prepares to issue a final rule later this year. CMS will need to digest all the public comments from all the usual suspects, and perhaps some not-so-public comments and back-room lobbying. We’ll see the results when the final rule comes out this Fall.

What will be Medicare’s final word? I’ve always loved both sausages and legislation, and I’m not put off by watching them made. In this case, I would have expected the “usual suspects” of dialysis-related groups to hit Washington with all their lobbying guns a-blazing. But so far, I think some of the key infantry is missing. And I can’t figure out why.

Patients. At the end of the day it’s all about the patients. Washington can argue the Trust Fund’s expected life until it’s blue (or red) in the face, but no emergency room is going to turn away a patient because the Feds projected a spending target too low. The sequester doesn’t throw Mama from the ambulance. So everyone knows it’s really the patients’ interests, and not the providers or the other players, that will shape Medicare’s thinking more than anything.

And where are those patients? That’s my point.

Sure, I’ve seen several groups put out their press releases when they submit a long letter to the CMS rulemaking docket. They speak in the name of patients, perhaps, but they also speak in the name of physicians, drug companies, ESRD clinics, and lots of other special interests. And ultimately, the Agency isn’t going to gauge the needs of quality care by the providers, so these comments won’t count.

It’s all about the patients. And who’s speaking for them?

So far, I haven’t seen folks stand up for the rights of an individual patient. Quality of care. Access to care. Attention to readmission rates. The pain and suffering of pushing small doses of ESA through a needle separate from the large doses earlier delivered with the dialysis.

Some of the comments to CMS seem to have it right. Rural areas, for one example, have terrible access problems as it is, and lower rates won’t cover the challenge of transportation and low-volume. There’s a huge rural health caucus on The Hill, and they might have more arm-twisting power with CMS than you’d think.

But what about the other patient care issues in the debate. To Congress, and the White House, and the Agencies like CMS, the debate also revolves on patient care issues, quality of care issues, and public health policy arguments. How can this be a patient-centered campaign looking at women’s issues, civil rights issues, or even a state-based Medicaid issue (long-term care costs should worry the Tea Party and the Democrats alike). And I’m not sure anyone is conducting this orchestra.

And for the most compelling issue, remember the mantra – it’s all about the patients. The one-doctor, one-patient relationship in clinical care. Because a doctor isn’t going to let a patient’s hemoglobin slip just because CMS capitated a low ESA dose into the bundle. Because it’s all about the patient you see at the bedside.

I can’t wait to see how CMS will set a final rule, given a serious cut in the proposed rule and very little good evidence to allow it to save face. And for the patient advocates in ESRD – where have you been?