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PharmTech
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PharmTech Europe
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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts. |
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Congress Approves Down Payment on Health Reform
In addition to providing tax breaks and investing billions to jump start the economy, the recently enacted economic stimulus package supports healthcare for the unemployed and takes steps to modernize the nation’s troubled health care system. When coupled with the just-reauthorized Children’s Health Insurance Program (CHIP), the new policies take important steps towards expanding health care coverage and setting the stage for future healthcare reform. Key health-related provisions in the legislation include:
Supporting the safety net The package also bolsters Medicare by blocking proposed reductions in reimbursement to teaching hospitals and hospice providers. And there’s an adjustment in payments to nursing homes. System improvements Yet, these relatively low-cost initiatives generated considerable controversy. There is broad support for doing more research on which treatments and medical procedures are most effective in patient care. The expectation is that unbiased expert evidence will prompt doctors to prescribe appropriate treatments and will reduce spending on ineffective procedures and products in the process. The fear of pharmaceutical and medical device companies, though, is that the program will be used to blast high-tech, high-cost products. Initial language accompanying the House bill stoked these worries by promising payoffs from CE analysis showing what’s most effective and should be utilized, and that less effective and more expensive products “will no longer be prescribed.” That phrase set off an eruption of dire warnings about treatment denials and government rationing. Pharma lobbied to describe the program as “clinical effectiveness” research and to kill any hints of treatment mandates or cost consideration. In the end, the CE research provision stayed in the bill without the term “clinical,” but also without any mention of cost. The language specifies that there is no intent to use CE data to mandate coverage, reimbursement or other payer policies. The measure also addresses fears of pharma and patient advocates that the new program will assess what treatment works best for the average patient and ignore the need for individualized therapy; the conference report notes that the program should consider patient subpopulations and should not lead to one-size-fits-all treatment. Industry also objected to focusing the CE research agenda on drugs, instead of much trickier comparisons of medical procedures. And the composition and functions of the new Federal Coordinating Council for CE Research makes manufacturers nervous. The final legislation, though, specifies that the Council won’t mandate coverage or reimbursement or issue clinical guidelines. But it’s generally understood that CE assessment funded by AHRQ or NIH will carry considerable weight and support coverage and reimbursement decisions by Medicare and insurers. Payers want CE research to consider costs, and that’s not prohibited in the bill. Wired nation The main source of controversy is the push to strengthen privacy protections for individual health records. Insurers, payers, providers, and pharmacists objected that added curbs on disseminating information will stymie efficient and effective care. They fear that new requirements for allowing patients to review personal records will be cumbersome and costly and are looking to HHS to develop workable regulations for an interoperable health IT system to materialize.
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