Happy New Year! The November elections are now behind us, and on Inauguration Day, Jan. 20, President Bush will be sworn in for a second term. The following week, or in early February, he will deliver his State of the Union address before Congress, which is the traditional start of the new work year here in Washington, D.C.

What will 2005 hold for kidney patients in Federal policy? Before answering that question, let us remember WHY public policy is important to kidney patients. WHY do decisions made by Congress and Federal agencies, such as the Centers for Medicare and Medicaid Services (CMS) that operates the Medicare program, make a difference to us? Because kidney patients’ lives depend on those decisions! This year will be no different!

At the beginning of each year, lobbyists and policy consultants to businesses and associations in Washington, D.C. typically make a list of issues that may affect their clients in the coming year. To be effective in Washington, an enterprise must be “proactive” – anticipating what may happen in order to be prepared.

So, what is the list of issues that may affect kidney patients? Here is what AAKP is watching right now:

Medicare Prescription Drug Benefit

On Dec. 8, 2003, President Bush signed into law the Medicare Modernization Act, which created a new, voluntary Medicare prescription drug benefit. That benefit will become available to Medicare members on Jan. 1, 2006 and provided by privately run prescription drug plans.

However, there are many, many decisions about the drug benefit program that CMS must still make in the next few months. Perhaps the most important decision is how much leeway prescription drug plans have in designing “formularies” – the list of drugs recommended by the drug plan that usually have lower cost sharing.

AAKP recommended that kidney patients have an “open formulary” – physicians have no restrictions on drugs they may prescribe kidney patients – because kidney patients typically receive many drugs, increasing the risk of adverse reactions, and some medications can cause additional kidney damage. .

Final Action on New Medicare Conditions of Participation (CoP) for Dialysis Clinics To receive Medicare payments, which pay for 75 percent of all dialysis treatment, a dialysis facility must meet Medicare standards, which include personnel and safety requirements. Current Medicare CoPs were written in 1976, which have never been updated! As of this writing, CMS is expected to release draft CoPs around Thanksgiving 2004 with a 60-day period for public comments.

Medicare Payment Advisory Commission (MedPAC) Recommendations on Outpatient Dialysis

Congress has its own agency, MedPAC, that publishes recommendations each March on Medicare payment and quality policies, including outpatient dialysis facilities. Check out MedPAC’s Web site for its current thinking about dialysis and its March 2005 advice to Congress at www.medpac.gov.

Medicare Legislation – and New Quality Initiatives

There is speculation that Congress may consider a Medicare bill in 2005. If so, will Congress write into law new quality care requirements for dialysis treatment and other improvements to medical care for kidney patients? Check out some quality ideas that Congress is considering in the September 2004 issue of aakpRENALIFE.

In addition, if you have not yet read AAKP President Brenda Dyson’s thought-provoking article, “The Quality Imperative: Why the Kidney Community Must Take Charge,” it is available by clicking here.

“Bundling” Demonstration Project

Last year, Medicare legislation created a demonstration project to include, or “bundle,” the costs of all lab and ESRD drugs into the “composite rate” or per session Medicare payment for dialysis treatment. That project is slated to start in 2006. AAKP is studying this project carefully with concerns that bundling may shortchange patients.

Other Medicare Regulations Affecting Kidney Patients

CMS will soon issue a revised policy on Epogen coverage (AAKP’s comments are located at www.aakp.org), as well as updated Medicare payment rules for dialysis facilities in August.

Other 2005 Coming Attractions

These seven items are the “short list.” Other important issues include Fistula First (Medicare’s initiative to increase use of fistulas), improved Medicare ESRD Clinical Performance Measures (Core Indicators), funding for scientific research on kidney disease at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Medicare’s new ESRD disease management demonstration project, dialysis-related investigations by the Inspector General of the U.S. Department of Health and Human Services and the U.S. Department of Justice, as well as the CAHPS Hemodialysis Patient Experience of Care Survey.

This article originally appeared in the January 2005 issue of aakpRENALIFE, Vol. 20, No. 4.

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