The New Medicare Prescription Plan
The new Medicare drug benefit plan is part of a much broader message. With oncology drugs accounting for about 69% of total Part B spending on prescription drugs and related services, the new Medicare Prescription Drug Plan Part D will even be more important for Senior cancer patients.
Beginning January 1, 2006, senior Americans with cancer may not even have to go to hospitals, let alone the infamous infusion-rooms of office-based oncology practices. That's because the new Medicare Modernizaton Act will offer them benefits they did not have before, such as coverage for oral chemotherapy drugs.
If prescribed an oral-dose chemotherapy drug, you will be given a prescription that you will take to your local pharmacy to have filled, just like you normally do with all the other prescription medications that you may be taking. Because it is a pill, patients can take it at home with only occasional visits to the doctor or clinic.
Oral chemotherapy drugs are treating cancer effectively and enhance the quality of treatment for cancer. Compared to infusional therapy, oral-dose cancer drugs can make treatment more convenient for patients by allowing flexibility, without disrupting work or other activities. Taking your medication at home allows you the freedom to carry on with your daily life. This results in less time spent in hospitals and private oncology practices because of the absence of intravenous administration and its related side-effects.
These targeted cancer therapies will give doctors a better way to tailor cancer treatments. Treatments may be individualized based on testing the individual properties of each patient's cancer. These new differences in therapy hold the promise of being more selective, harming fewer normal cells, reducing side-effects, and provide a savings in health care costs.
If you have a private health plan which has a good prescription plan, in the vast majority of cases, you will want to continue in your plan. Four in five businesses that provide prescription drug coverage for their retirees will accept a government subsidy next year and continue providing that benefit. Under the Medicare law, the government provides businesses with a new financial incentive to continue providing retirees with prescription drug coverage: a tax-free subsidy equal to 28 percent of the retiree's drug costs. The subsidy means that a typical company will save about $626 per retiree next year, the survey showed.
If you want to apply for the new Medicare prescription benefits, you may do that also. People who don't have coverage, who are very low income, this is an important supplement to their Medicare coverage. But people above the low-income subsidy really have to look at the different private plans closely. It is the poor that stand to gain the most from the new benefit. That's because the government will subsidize their coverage to the extent that many will have no premium, deductible or gaps in coverage. However, the government wants the privately-sponsored plans, and not the government-sponsored plan to do this. People who qualify for such aid must have limited assets and a maximum annual income of about $14,355 for individuals or $19,245 for married couples.
The biggest problem with the Medicare prescription plan, was in designing the program. This administration did not want the Medicare drug benefit to be administered directly by the federal government (where Medicare is run efficiently). Instead, it devised a public program run by hundreds of competing private plans, each with its own prices and coverage policies.
Oral chemotherapy will be handled the same as "infusion" chemotherapy by Medicare, but under plan D instead of plan B. However, if you can and want to utilize a lot of the generic or older drug agents, the cost would be significantly less. Most infusional therapies are typically biotechnology drugs made of complicated proteins that are injected. This makes them several times more expensive than traditional pill-form pharmaceuticals.
A Beneficial Side Effect of the Medicare Drug Benefit
An unintended effect of the Medicare Part D benefit could be the creation of the world's most valuable resource for understanding how drugs are used, especially by the elderly and the chronically ill, and their risks and benefits. This resource would be created by linking information on drug dispensing to patients' other health information. Medicare data are available for more than 40 million people. These data can transform our ability to assess drugs under real-life conditions, particularly in this vulnerable population, which is often underrepresented in clinical trials. However, in order to realize this benefit, we must make it a priority, justify it to the public, and provide adequate funding.
To understand the opportunity before us, it helps to understand how little we know now. The Food and Drug Administration (FDA) often approves a drug for long-term use on the basis of minimal long-term safety data: as few as 100 people may have been followed for adverse effects in studies lasting at least one year. Furthermore, the FDA rarely can compel manufacturers to conduct postapproval studies. The current mainstay for drug safety is the spontaneous reporting of adverse events to the FDA's MedWatch program, which suffers from underreporting, variable data quality, and the lack of a mechanism to assess confounding risk factors. Spontaneous reports are a particularly poor instrument for detecting increased risks of common conditions, such as cardiac disease, that greatly affect public health.
The lack of systematic collection and analysis of post-marketing data on the use of drugs and the outcomes of treatment has delayed the discovery of some serious problems until after millions of people have been exposed. For example, cisapride (Propulsid) was withdrawn because it had been prescribed to many people with contraindications, and several coxibs are now known to increase the risk of myocardial infarction.
Two existing programs share features that can be adopted for Medicare data. First, the Vaccine Safety Datalink Project of the Centers for Disease Control and Prevention, which involves the use of linked data from health plans, is an invaluable source of data on vaccine safety. Second, the FDA makes some use of linked pharmacy and administrative records from health plans. These databases identify everyone who is eligible to receive a drug or vaccine, the starting and stopping dates of administration, and many outcomes and coexisting medical conditions. In addition to being useful for safety studies, these data sometimes allow assessment of the effectiveness of different therapies under conditions of actual use.
There are important limitations to these data, however. They do not identify some conditions with sufficient specificity, contain no information on actual drug ingestion, lack important information such as smoking status and body-mass index, often lack historical information, and include only drugs covered by the health plan. Therefore, it is important to review patients' full medical records in the small number of cases in which this information is critical.
Some prerequisites already exist for using Medicare data linked with data from health plans to study the use, risks, and benefits of drugs. Most important, the Centers for Medicare and Medicaid Services (CMS) has proposed linking Medicare drug claims with diagnosis and procedure claims. In addition, the FDA has experience in working with linked data and in collaborating with expert groups such as the Centers for Education and Research on Therapeutics (funded by the Agency for Healthcare Research and Quality and administered by that agency in collaboration with the FDA).
To take advantage of the opportunity at hand, the CMS must carry out its proposal of creating a fully linked data set and ensure that it remains current. The CMS, the FDA, and their designees will need the ability to review selected outpatient and inpatient records. These agencies will need to clarify their authority to perform these reviews and explain their purpose satisfactorily to clinicians and patients. Finally, the FDA and other agencies will need new sources of funding if they are to use this information meaningfully and to conduct research on new methods for using it optimally. Additional issues, such as a means of sharing these data with researchers and others, must also be addressed.
Medicare data will offer a great opportunity to improve our ability to understand the balance of benefits and risks of drug treatment. If we take advantage of this opportunity, we will know much more about whether drugs are used as intended, whether they have their intended effects, and how risky they are.
Dr. Platt is a professor in and chair of the Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, and principal investigator of the HMO Research Network Center for Education and Research on Therapeutics, Boston, and principal investigator of an FDA contract (HHSF 223200510010C) to perform post-marketing surveillance for drug risks and benefits. Dr. Ommaya is a senior staff member at the Institute of Medicine, Washington D.C.
The New England Journal of Medicine