Certainly one of the most important stories in Washington in 2007 is the Democratic takeover of both Houses of Congress for the first time in 12 years.

A new Congress means a new direction for many areas of healthcare policy. For instance, we will see legislation to allow the reimportation of drugs into the United States, and to lift the ban on government negotiation of prices for prescription drugs under Medicare.

The New Lineup

The new players assuming power in the 110th Congress will have an important impact on renal care as well. With the new Democratic control of Congress comes a slate of new Democratic chairmen of congressional committees. Fortunately, many of these new committee chairs are familiar with and supportive of critical kidney care issues. In the House of Representatives, Rep. Charlie Rangel (D-NY) takes over as Chairman of the powerful Ways and Means Committee. Many years ago Congressman Rangel served as an honorary chairman of AAKP and he remains an important ally on our issues.

Rep. Pete Stark (D-CA) now chairs the Ways and Means Health Subcommittee. Congressman Stark and his staff have already indicated to AAKP that he wants to push ESRD legislation in this Congress, possibly to have Medicare coverage kick in earlier in the process of chronic kidney disease (CKD). Rep. Dave Camp (R-MI) has been named the ranking Republican on the health subcommittee – good news considering Rep. Camp’s sponsorship of bills to extend immunosuppressive drug coverage and improve quality of care in previous years.

On the Senate side, Senator Max Baucus (D-MT) has become the new chair of the Senate Finance Committee. In the last Congress, Senator Baucus introduced the Medicare Value Purchasing Act (S. 1356) to create financial incentives that would promote quality care and better value in the Medicare payment system. He worked closely with Senator Chuck Grassley (R-IA), now the ranking Republican on the Finance Committee.

All but one of the House members of the Congressional Kidney Caucus who sought reelection returned to Congress. Senator Mike DeWine (R-OH), a strong supporter of kidney care issues, was defeated for reelection. If your district is represented by a new Member of Congress or if your state elected a new U.S. Senator, make sure they hear your voice on matters of importance to kidney patients!

Last Year’s Last-Minute Flurries

In the very last days of the 109th Congress, there was significant activity related to the ESRD program that may set the stage for action this year.

An Increase for Dialysis Providers: Just before Congress adjourned in December, legislation was enacted to give providers an increase in the reimbursement rate for ESRD services. Dialysis services under Medicare will receive 1.6 percent more than the year before and will increase an additional 1.6 percent on April 1, 2007. Let’s hope providers use the payment increases wisely in ways that enhance the quality of dialysis services. And with the provider update issue resolved at last – at least for the time being – more attention can be paid to other important issues.

 Home Dialysis: In the same last-minute legislation in December, Congress called for the U.S. Government Accountability Office (GAO) to conduct a study of home dialysis. The GAO report, due by Jan. 1, 2009, will look at the costs of home hemodialysis treatment and patient training for both home hemodialysis and peritoneal dialysis. It will also make recommendations for payment under Medicare for home dialysis.

One of AAKP’s top policy priorities is to ensure Medicare coverage for home dialysis for those patients who want to use that option. Requiring a GAO study is an important first step forward in that process.

Hearing on ESRD: On Dec. 6, the House Ways and Means Committee held a hearing on the ESRD program. AAKP submitted written testimony for the record and Acting CMS Administrator Leslie Norwalk identified AAKP as “the patient association.” The hearing demonstrated tremendous concern over what is seen as possible overdosing of patients with Epogen, and whether such overdosing is costing the Medicare program too much money. It was suggested several times that the use of subcutaneous (by injection) dosing of Epogen (as opposed to intravenous administration) could save millions of dollars.

AAKP surveyed more than 3,000 patients in the late 1990s to see how patients felt about subcutaneous administration. Perhaps surprisingly, the vast majority of patients were fine with subcutaneous administration – noting that, for example, “it really didn’t hurt too much,” they were “used to needles,” or they understood the reasons why the drug had to be given in such a manner. Patients in the veteran’s health system are already dosed by subcutaneous administration.

The major outcome of the hearing was to push CMS to move forward on a bundling demonstration project in which all facility administered drug payments would be bundled into the facility reimbursement. CMS currently has a board developing the demonstration project – called the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for ESRD Services – of which AAKP is a member. Look for further action on this issue this year.

Who’s on First?

It is always difficult to predict at the beginning of a new Congress which policy areas are most likely to see legislative action. But for kidney patients, the areas likeliest to see legislative action first may be: Medicare coverage; immunosuppressive drugs and kidney donations.

 Earlier Medicare Coverage:

Congressman Stark has indicated an interest in having Medicare coverage begin earlier than it currently does in the ESRD program. With providing fistula access, for example, there are significant health benefits to performing the procedure earlier than the point at which ESRD eligibility becomes effective.

Any move to make patients eligible for Medicare at an earlier stage in their kidney disease, however, will prove extremely costly. New budget rules adopted by the Democratic Congress to require budget offsets for any increases in spending will make it difficult for Rep. Stark and others to expand ESRD coverage. But if budget savings can be found, this is certainly an area of great interest.

Immunosuppressive Drugs:

For kidney transplant recipients under age 65, Medicare only covers immunosuppressive drugs for about three years. Too many low-income people cannot afford to continue taking these critical lifesaving drugs after Medicare coverage expires. Without immunosuppressive drugs to keep kidney transplants from being rejected, many patients find themselves right back where they started: in need of a kidney. This circular cycle of care is costing taxpayers a lot of money and putting thousands of lives on the line. Providing lifetime coverage for immunosuppressive drugs through Medicare could reduce the number of graft failures and reduce the need for dialysis and kidney re-transplants. In the long run, both money and lives would be saved.

AAKP is pushing hard for legislation to eliminate the 36-month cap on immunosuppressive drug coverage for those eligible for the ESRD program. Many lawmakers now see the need to do so. Some have suggested starting first with pediatric patients if extending coverage for all patients is too costly.

Paired Kidney Donations:

History was made last November when doctors at Johns Hopkins performed the first-ever quintuple kidney transplant. Twelve individual surgeons simultaneously operated for 10 hours on 10 different people – successfully transplanting organs into five patients in need of a new kidney.

This dramatic life-saving event helps explain the tremendous benefits that can result from such procedures. Senator Carl Levin (D-MI) and others are pushing strongly for legislation to ensure these “paired” kidney donations do not violate current federal law prohibiting compensation for organ donations. It is estimated that paired kidney donations could increase the number of organ transplants by 1,500 to 2,000 each year!

 John A. Schall is a vice president at Jefferson Government Relations.

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