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Home > Press Room > Interviews & Features > 2001 M C & C Roundtable > Page 3

Pending Changes in Medicare (continued)

MS. DAVENPORT-ENNIS: I agree, it is awkward. But there is a group that's been working on this issue since September. There are members in both the Senate and the House who are poised to introduce legislation addressing the need for a mechanism to be available to Americans by the end of this year so that there can be reimbursement for oral anticancer products. Now, certainly every person who is working in Washington right now wants to see a prescription benefit bill passed. Even though there is a high level of enthusiasm for seeing that done, Senator John Breaux (D-LA) suggested recently that we can't just put out a prescription benefit bill for a system that is not working. We need to completely reform HCFA. I think supporters for oral anticancer coverage this year are saying that if we cannot get HCFA reformed this year, and if we cannot get a prescription benefit bill passed this year, at the very least, we must assure Americans that there is going to be a mechanism for reimbursing oral anticancer products.

DR. GOODMAN: This is certainly an instance where new technology could outstrip current payment policy. While a new Medicare prescription drug benefit could provide an overarching solution, it may be something we really can't count on seeing any time soon. In the meantime, technology marches on and patient demand for that technology marches on apace.

MS. DAVENPORT-ENNIS: A good example is STI-571, which is being used in leukemia patients. Those patients have very few options available to them, period. And in the clinical trials of this oral anticancer drug to date, the results are phenomenal, like nothing we have ever seen in cancer clinical trials. Even the FDA has taken this product and put it on an accelerated track for approval because there is no other product that can begin to offer the same promise or hope to cancer patients. But as it is, if STI-571 were to be approved by the FDA tomorrow, there is no provision for reimbursement, no matter how good those clinical trial results are. And in the United States, health plans in the private sector often look to see what HCFA is doing with regard to reimbursement policies and practices before making their own decisions.

DR. GOODMAN: Now that we've gotten into the Medicare prescription drug benefit let's take it on directly. Tom, can you give us a little update as to how things stand with regard to the benefit, including in the House and Senate proposals?

MR. AULT: What we really should look at first is the budget resolutions that have been adopted by the House and Senate and the president's proposal. President Bush's proposal is for his Immediate Helping Hand initiative, and I believe he's included $153 billion in his proposed budget. This would provide help for low-income Americans; they would pay nothing for drug coverage up to 135% of poverty [income up to $15,700]. They would pay some contribution between 135% and 175% of poverty [income up to $20,300]. And there are other aspects to this proposal for others as well. In its budget resolution, the House of Representatives included the same amount, $153 billion, but no specific legislation has seen any committee action yet. The Senate budget resolution included about twice that much, approximately $300 billion. Unfortunately, part of the funding for that is coming from the budget contingency, which is going to have many competing items, including the defense budget and agriculture subsidies. So it's really unclear how much money is going to be available in the Senate or in the House, and leaders of both parties have said that $150 billion is inadequate. Also, you have the most relevant committee chairmen saying they're going to be considering legislation and reporting it out of committee this year, but you have the leadership in both the House and Senate saying that they don't expect to see chamber action on it until next year. So I think the outcome is very much up in the air at this point in time.

MS. DAVENPORT-ENNIS: I think that it's problematic when we look at the extremes of what the costs are going to be. Senator Breaux was in a meeting with an organization that I was with a couple of weeks ago. He said that if we had a prescription drug benefit bill introduced in this country now, it would only cover 50% of the drug bills for our seniors enrolled in Medicare; it would cost us $728 billion. Now if we moved to a position where we were going to pay all of the prescription drug costs for these seniors over $1,000, that number would move up to $1.1 trillion. So that's a problem. I think another challenge that we see in the programs they're suggesting, such as Helping Hand, is that the federal government is going to give funds to the state governments to help those seniors who need it most. Many of the states are saying they do not have the funds to help seniors, and the money that's being proposed from the federal level doesn't appear to be enough to do what is needed at the state level. So I think that's a concern. In fact, as it stands now, it doesn't matter whose plan you consider today. There's wide divergence on how much money it's going to take the government to run it, how much money the American consumer is going to have to contribute, both in paying for it initially through policy costs as well as copayments, and where the stop-loss is going to kick in. It's certainly a very unsettled issue.

DR. GOODMAN: From the standpoint of oncology, are patients who need cancer care more or less vulnerable to the ranges in the amount of financial requirements, including out-of-pocket payments, for a Medicare prescription drug benefit? Is it once again the Medicare cancer patients who are most at risk?

MR. AULT: I think the cancer patients on Medicare are not currently at great risk, because Medicare coverage is as good as private coverage right now. That's because most of the drugs are administered intravenously and covered by Medicare. Moreover, Medicare continues to pay AWP minus 5%. But the concern we're expressing results from some of the changes that are in the offing, like oral drugs being developed that do not have an IV equivalent and the prospect of Medicare dramatically lowering its payments below AWP minus 5%. For now, I think the Medicare patient is fine, but there are storm clouds in the future.

MS. DAVENPORT-ENNIS: It's been our experience and last year at the Patient Advocate Foundation we handled over 29,000 cases-that the Medicare enrollee still has a very tough time in the cancer care delivery system if the only coverage they have is Medicare. Medicare is very conservative, and offers a narrow margin of access to very standard, traditional therapies. If a Medicare patient is diagnosed with a cancer and the best hope lies with a newer, more evolving therapy, he or she has a tough time getting it. The Medicare patient, for example, has a very hard time getting some of the medications that are designed to offset hematologic toxicities or to take care of the miserable side effects that can result in secondary hospitalizations. From our perspective, the current Medicare program could stand some improvement, and certainly when we look at a prescription drug benefit in the system, we want to ensure that it's going to give seniors more access than they currently have. I completely agree with Tom that at least we do have a modicum of coverage through the current Medicare Part A and Part B system, but there's plenty of room for improvement.

DR. GOODMAN: Let's move on to a way to speed new therapies through the pipeline. Pursuant to an executive order, HCFA issued a national coverage decision in September 2000 to cover the routine or nonexperimental costs associated with clinical trials. In principle, this should provide an additional avenue and a faster track for new technologies to be considered for coverage. From a practical standpoint, will this actually lead to faster consideration of new technology and make it accessible to patients more readily?

MR. AULT: This is a national coverage decision, as you said Cliff, and yes, I think it's a very significant action that will lead to improved coverage by Medicare. It's not going to lead to coverage of an unapproved cancer drug, because the drug itself is not eligible for payment under this new policy. Only routine patient care costs associated with treatment received in a clinical trial will be reimbursed. It's a big improvement, but it doesn't actually pay for the drug. Now, if there's a clinical trial of an off-label use of a drug that's already been approved by FDA for some other indication, then Medicare may pay for the drug and for the clinical trial. I think that some of the difficulties here are going to be how quickly this is actually going to get implemented in the field with clarifying instructions and so on. I think there's been some delay there.

DR. GOODMAN: Nancy, do you see this as a positive development?

MS. DAVENPORT-ENNIS: Absolutely. I offer three points about the issue. First, Tom is right, we are seeing major challenges to implementation, We're seeing people who are in the Medicare system whose physicians have referred them for enrollment in a clinical trial, but they are denied by Medicare. As soon as we intervene on a one-on-one basis we're able to get it reversed, but the reason they were denied is that there simply was not a mechanism in place for routinely enrolling people in the trial through HCFA. Second, for the first time in this country, there will be very significant opportunities to increase our knowledge of how seniors respond to chemotherapy and other experimental modalities, and we see that as a plus. Moreover, patients who are being treated in a clinical trial usually do better than those who are not, because they're followed and monitored very closely, and because there's early intervention when secondary problems present themselves. Finally, the Coalition of National Cancer Cooperative Groups reported recently that a number of health plans have voluntarily agreed to cover routine costs associated with clinical trials for their members. These plans cover over 150 million Americans. This came about as a direct result of the HCFA change. So I think it has a favorable impact on the private sector, and it certainly has a favorable impact for the senior citizens.

DR. GOODMAN: So, even though the experimental technology itself is not reimbursed, virtually all the surrounding routine and ancillary costs are going to be covered, which lowers the hurdles for conducting these clinical trials. That should be beneficial not only to the Medicare community but to other populations as well. Further, Nancy and Tom, it sounds as though you concur that HCFA's providing Medicare coverage for these clinical trials will spill over into similar involvement by the private sector payers.

MR. AULT: Absolutely, I strongly agree with that.

MS. DAVENPORT-ENNIS: Yes, without a doubt.

DR. GOODMAN: This is a very important development, allowing a new avenue of transition from experimental therapies to standard or accepted therapies. This ought to help break down the traditional, binary, pay/no-pay coverage policies that we've seen by all third-party payers, and provide a more rational transition from the new to the accepted. That is to be very much welcomed, particularly as it involves HCFA, which is the world's largest third-party payer. This initiative sets a fine example for other payers as well, and stands as an important development in technology assessment and payment policy.

MS. DAVENPORT-ENNIS: Very significant, and it also has a very favorable impact on the accrual of patients to trials. If we can expedite the accrual process, than we can collect enough data to get answers more quickly than we have been able to in the past.

DR. GOODMAN: Exactly. One of the challenges of assessing new technology is that much of the initial evidence is based on use of the new technology in patient populations that may be younger or otherwise constituted differently than the Medicare population. Now, the barrier is lowered for conducting these trials with large groups of Medicare patients, which will provide a stronger base of evidence pertaining to Medicare beneficiaries. This will have great practical significance for clinical practice guidelines and other patterns of care.

MS. DAVENPORT-ENNIS: We hope it will also set a standard for Congress to look at as it considers what it's going to do with a patients' bill of rights this year. It can help motivate them to be certain to include the same form of coverage in that document, with provisions for patient involvement in clinical trials and protection of the data.

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