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While we continue to have concerns--also echoed in the FTC report about the 12-year exclusivity period included in the Senate HELP Committee compromise, we believe that the underlying legislation that includes Chairman Kennedy’s amended language to close the so-called “ever-greening” loophole is a constructive and important contribution that merits inclusion in this package. We therefore believe it should be included in the Committee health reform mark. Conversely, if the ever-greening provision is not addressed, we believe that this legislation would represent an empty promise in that it would set up an environment in which biotech companies could make modest changes to the underlying product and get continual 12-year cycles of effective monopoly protection.

We appreciate the continued leadership of Committee members Senators Kennedy, Brown, Hatch, Enzi, and Bingaman on this issue. We look forward to working with them on the promise that on this – the 25th Anniversary of the Hatch-Waxman law – we provide a workable pathway for generic options in order to provide more choice in a marketplace that works to the advantage of consumers.

Lowering the costs of biologic drugs also presents an opportunity to begin to close the coverage gap – or doughnut hole – in the Medicare Part D benefit. This is an issue of great concern to AARP members. About one in four Part D enrollees, not enrolled in low-income subsidies, who filled one or more prescriptions in 2007 fell into the doughnut hole in 2007, according to a Kaiser Family Foundation report. On average, patients’ out-of-pocket drug spending doubles when they reach the doughnut hole. A pathway to generic biologics can help more people avoid the coverage gap, as well as provide savings to begin to close the doughnut hole.

Health Quality and Delivery System Reform

Care for people with chronic conditions makes up three quarters of total health spending, yet many experts agree that much of the health care system is not well organized to meet the needs of people with chronic conditions. Clinicians tend to focus on the particular problem that a patient presents at each visit. But delivering good care for people with chronic diseases calls for proactive steps by both individuals and providers to care for chronic care between visits. For patients, this could include adhering to advice on exercise and diet, taking medications as prescribed, and monitoring signs and symptoms. For providers, this includes monitoring care over time and settings and having good systems and communication – among providers and with patients and caregivers – that allows tracking and patient-centered care.

Barriers to improvements in care for people with chronic disease include the fragmentation of care delivery, poor transitions between and among settings, and misaligned payment incentives that fail to recognize the value of better integration of services. Poor information systems make these problems worse because providers find tracking patients over time and across settings difficult. Adherence to medications is a key component of effective chronic care management, and patient’s failure (or inability) to take prescribed medicines is another major barrier to improvement.

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