Medicare cuts endanger hemophilia sufferers

THE PRESCRIPTION DRUG and Medicare Improvement Act of 2003 has one major flaw--reimbursements on medical supplies and home health care. The problem is that legislators are embracing a new reimbursement model without fully understanding its impact on the hemophilia community. With the new higher cost of care items, patients will not have access to critical home care services, which will delay necessary treatment.

In terms of treatment, hemophilia is the fifth most costly chronic disease. At present, the in-home health care industry saves hospitals thousands of dollars per patient per year Medicare Act reimbursement cuts, however, will drive individuals with hemophilia into hospitals and emergency rooms at a much greater cost to the system. With lifesaving home care services out of roach, interminable treatment delays will drive up the frequency of crippling episodes and fatalities as well as heap additional expenses on the Medicare system. If this sounds overly dramatic, talk to the thousands of individuals throughout the U.S. who have hemophilia for whom this legislation could be a matter of life and death.

According to Jonathan Goldsmith, president of the Immune Deficiency Foundation and former director of several hemophilia treatment centers: "People with hemophilia need access to their life-saving factor in a timely fashion, and if they don't receive prompt treatment at the first sign of bleeding--which is often in a home setting--then they will have problems that include progressive joint damage and bleeding into vital areas that could have very serious health consequences."

"We have been fighting a reimbursement nightmare for the past three years," relates Jan Hamilton, executive director of the Hemophilia Federation of America. "If people with hemophilia can't continue to get their product at home, and they have to go back to the emergency room or the doctor's office or the hospital to get it, we've just lost 20 years of progress."

At issue is a significant restructuring of the core reimbursement methodology used by Medicare for the biological blood dotting "factor" patients require to prevent or stein bleeding episodes. The Medicare Act outlines a shift from the current reimbursement rate of 95% of the Average Wholesale Price (AWP) per unit to a calculation based on Average Sales Price (ASP) plus a nominal administration tee. By all accounts, this represents a dramatic reduction in the amount of reimbursement that provides for blood clotting factor and a few ancillary supplies. Moreover, it leaves little else to cover a host of services that hemophilia patients rely on to allow for immediate treatment of bleeds in the home.

While this might appear to be sound fiscal belt-tightening, advocates argue that legislators are embracing this new reimbursement model without fully understanding its impact. For instance, the new structure is based heavily on the recommendations of a report from the General Accounting Office, yet the GAO has acknowledged that it had insufficient data to provide an estimate of the costs of the administrative services provided by home care companies dispensing factor. This is a major flaw that could leave key home care services uncovered and, therefore, unavailable to patients with hemophilia.

"If a patient is not able to infuse quickly and treatment is delayed, there can be any number of serious or life threatening consequences," warns Hamilton. "If the bleed is in a knee, elbow, or any joint, the individual could possibly develop crippling in that joint because of the delay in treatment. If it's a head bleed, the final destination could be the morgue."

There are an estimated 25,000 people living with hemophilia in the U.S. The malady occurs when an essential protein is missing that prevents blood from clotting properly. To manage the disorder, blood clotting factor is infused (injected) to replace the missing protein. In severe cases, infusion is required several times a week, and more frequently if a bleeding episode occurs.

An adult with severe hemophilia typically will experience eight to 10 bleeds per month and self-administer 1,500 to 4,000 units of clotting factor per infusion. Annually, clotting factor costs usually are between $150,000 and $225,000 for an adult with severe hemophilia.

On Jan. 1, 2005, the reimbursement for such drugs will move to a more complex "market-based payment system" that will do away with the concept of AWR This change represents a major reduction in reimbursement per unit of factor, sufficient to cover the cost of the factor itself and a few ancillary items, but little else. Furthermore, the Medicare Act directs the Secretary of Health and Human Services to determine such payment "for items and services related to the furnishing of [factor] in an amount that the Secretary determines to be appropriate." This fee may "take into account any or all of the following: (i) the mixing (if appropriate) and delivery of factor to an individual, including special inventory management and storage requirements. (ii) Ancillary supplies and patient training necessary for the self-administration of such factors."