Recent actions by Congress and the administration are threatening to slow progress being made in cancer research and treatment.
The Medicare reform bill is expected to be signed into law by President Bush now that it has been passed by both the House and Senate.
The Senate passed the legislation by a 54-44 vote on Tuesday, November 25. Prior to the Senate action, in the early hours of Saturday, November 22, the House of Representatives approved the Medicare reform bill by a 220-215 vote.
In a rarely used exercise of leadership privilege, the voting period in the House, which normally lasts 15 minutes, was extended to three hours to give time to the congressional leadership to convince a number of representatives to change their votes. The initial tally was 216-218 against the legislation.
Medicare Reform Lowers Oncology Drug Reimbursements
A number of political observers have commented that many Medicare beneficiaries will benefit from the proposed bill and some would not. Among those who will not are patients with diseases that require complex and costly treatments and drugs—especially cancer patients.
In an immediate threat to access to cancer care, the provision to cut reimbursements for oncology drugs as reported in the past two issues of the Myeloma Minute remains essentially unchanged.
In a letter to every member of Congress, the American Society of Clinical Oncology (ASCO) expressed its' disappointment of the provisions affecting cancer patients. The letter "reinforce[s ASCO's] oft-stated concerns that the pending reductions will seriously affect access to cancer care throughout the United States," and that "the drug benefit should not be accomplished at the expense of quality cancer care for...beneficiaries."
Commenting on the proposed change that will take as much as $16 billon out of the oncology drug reimbursement system over the next ten years, the ASCO leadership writes, "The effect of these very substantial changes in payment will be significant for cancer care in communities across the country. Among other things, we are anxious that these changes will have significant unintended consequences for cancer clinical trials upon which we all depend for progress against disease for future generations."
Prescription Drug Benefit Impacts Cancer Patients and Oral Drugs
The prescription drug provisions in the Medicare bill leave very much to be desired for cancer patients. The full plan will not be implemented until January 1, 2006. It is expected that a prescription drug card will be made available to Medicare beneficiaries by April 2004 that will provide discount of up to 15%.
After January 1, 2006, the new formulas for premiums and out-of-pocket expenses for prescription drugs—including those for cancer treatment—will go into effect. Monthly premiums will be $35, totaling $695 per year. Annual deductibles will be $250 before any coverage begins.
There is a so-called "donut hole" of coverage for annual drug costs between $2,250-$5,100. Under the plan, Medicare will pay co-payments for at a rate of 14% for drug costs up to $3,000 and as much as 57% for drug costs totaling than $5,000, but beneficiaries will be responsible for all out-of-pocket expenses within that range. According to a Kaiser Family Foundation study, this will translate into $1,950 out-of-pocket expenses for the first $3,000 of drug costs and $3,950 for the first $5,000. Higher drug costs will be covered at higher percentages.
Although the bill would add approximately 14 million Medicaid beneficiaries to the plan who will be exempt from many of the co-payment provisions, it is clear that the new costs will be very high for low-income beneficiaries who do not qualify for Medicaid.
Mixed Messages for Oral Drugs Coverage
Although the legislation eventually promises to cover the costs for oral cancer drugs when fully enacted on January 1, 2006, the benefit may prove to be expensive for patients. It is also unclear what the coverage would be for off-label use of drugs.
Prior to this January 1, 2006, the bill provides a for very limited demonstration project that will impact relatively few cancer patients.
According to a summary of the conference report produced by the House Ways and Means Committee, the bill has designated a $500 million fund to create "a 2-year demonstration project in 6 states covering more than 50,000 patients...including oral anticancer chemotherapeutic agents." Subsequent statements from congressional staff have indicated that the 6 state provision was an error and that the demonstration project would be implemented nationwide.
The demonstration project also would include coverage for self-injectable drugs for rheumatoid arthritis and multiple sclerosis. For cancer patients, the bill states that "no less than 40 percent of the funding shall be for oral cancer" which will translate to about $220 million. The demonstration project "is required to begin 90 days following enactment [of the bill] and end no later than December 31, 2005."
A full text of the language can be found on pages 253-4 of the summary of the bill produced by the House Ways and Means Committee at http://waysandmeans.house.gov.
Appropriations Unlikely to See Significant Progress
As reported in the past two issues of the Myeloma Minute, the Labor, HHS, and Education appropriations legislation will either be considered on its own or as part of an omnibus bill which will combine a number of unfinished funding bills. Congressional sources have indicated that spending in the bill will increase by $1.2 billion.
It is expected that most of the increase will be applied to the National Institutes of Health (NIH) to bring the total closer to the 3.7 percent increase requested by the Senate. While an improvement over the House increases of 2.5 percent, the additional funding will be a pyrrhic victory at best. The fact remains that the National Cancer Institute now only funds 28 percent of its approved grants and that percentage is likely to fall without an increase in funding of 8-10 percent.
The expected national deficit this year will approach $500 billion. If we are to live in an environment of deficits, which will be likely for years to come, especially when we have spent close to $160 billion just to wage war and occupy Iraq over the past two years, then it is truly unfortunate that leaders in Washington will choose to limit increases of medical research spending in order to preserve an illusion of fiscal restraint.
The fact is that there is good debt and there is bad debt. On a personal level, a home loan is good debt and out of control credit card expenditures are bad debt. On a national level, there is no better debt that we can engage in than funding for medical research. It is an investment in a better future. It is unfortunate that the leadership will spend less than $29 billion for NIH next year while they approve an annual budget of $87 billion for occupying and rebuilding Iraq. And that figure will promise to grow at a greater rate than we will increase NIH funds.
Future of Accessible Emerging Technologies for Cancer Patients Unclear
Last week Secretary of Health and Human Services Tommy Thompson commended the conferees of the Medicare bill for "com[ing] together and tak[ing] advantage of this opportunity to finally deliver modern medicine in a modern way for Medicare beneficiaries."
As delay of comprehensive oral drug coverage and its potential costs to patients demonstrate, for cancer patients this Medicare bill threatens to ignore the "opportunity to finally deliver modern medicine in a modern way."
This bill does not recognize that cancer treatment is entering a stunning era in which genomic and proteomic targeted drugs have the promise to replace current treatments, most notably, chemotherapy. These drugs will be expensive and they will need to be rapidly developed in order to eliminate as much death and suffering due to cancer as soon as possible. This goal is achievable.
Unfortunately, neither Congress nor the administration seem to be taking this promise seriously. By enacting the current Medicare bill under consideration—potentially pricing effective therapies too high through an inadequate reimbursement system—and by slowing down research by not funding NIH at the levels needed to maintain the momentum of medical research that has been realized in the past few years, they have made a promising future for the cancer community seem less so.
When the Bush Administration took office, the education initiative No Child Left Behind highlighted its vision for a better future. Unfortunately the current course taken by the administration and Congress threaten to Leave Many Cancer Patients Behind.