Tag: drugs

21st Century Cures

lancet cover 212 August 2015
A dispatch from our Washington correspondent on the sluggish progress of the 21st Century Cures Act.
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Republicans and Democrats in the U.S. House of Representatives last month overwhelmingly passed the 21st Century Cures Act  aimed at speeding up drug development.  But the Senate is not expected to vote on its version until next year.
More than 80 percent of the House backed the legislation after it was unanimously — a word rarely heard on Capitol Hill — approved by the House Committee on Energy and Commerce.   In the process, the bill was revised to address concerns that drug approvals would happen a little too quickly, circumventing safety and efficacy standards. [Continued here]

Planning for US Precision Medicine Initiative underway

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Volume 385, Issue 9986, 20 June 2015

WORLD REPORT    Officials expect to launch the US President’s new health project later this year. But Congress has yet to decide whether to fully fund it. The Lancet’s Washington correspondent, Susan Jaffe, reports.

While continuing to defend his besieged health-care reform law against lawsuits and repeal threats, US President Barack Obama is championing a new health initiative. This one also has a bold goal: to radically change the medical treatment patients receive in the USA. “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time”, the President said when he unveiled his Precision Medicine Initiative (PMI) in his annual State of the Union address to the nation in January.  …Central to the PMI will be the creation of a research cohort of 1 million US volunteers who agree to provide researchers with biological, environmental, lifestyle, and other information as well as tissue samples….The effort to vastly expand the scope and practice of individually designed treatments based on genetic information could revolutionise medicine, supporters say. But the success of the PMI depends on whether Congress agrees to fund it.  [Continued in full text or PDF ]

Medicare Modifies Controversial Hospice Drug Rule

By Susan Jaffe   |  July 18th, 2014 |  KAISER HEALTH NEWS     

In response to strong criticism, Medicare officials are modifying rules intended to prevent the agency from paying twice for the same prescriptions for seniors receiving hospice care.

Under the rules that took effect in May, hospice patients or their families could not fill prescriptions through their Part D drug plans until first confirming that the prescriptions were not covered by hospice providers. Drugs related to palliative and comfort care are supposed to be covered under the fixed rate payments to the hospice.

Medicare announced Friday that the rules would be revised so that the additional authorization would be required for only four types of medications: pain relievers, anti-nauseants, laxatives, and anti-anxiety drugs that are “nearly always” considered hospice-related.

“Medicare really tried to address our concerns quickly and effectively,” said Terry Berthelot, a senior attorney at the Center for Medicare Advocacy. [MORE]

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A new law passed in July to strengthen the work of the US Food and Drug Administration may hit some serious barriers to implementation. Susan Jaffe reports from Washington, DC.

image WORLD REPORT   Volume 380, Issue 9852, Pages 1458 – 1459, 27 October 2012

The massive drug and medical device safety bill that won extraordinary near-unanimous support in the US Congress—despite a budget crisis and a contentious political campaign—is facing major challenges less than 3 months after President Barack Obama signed it into law in July. And in the process, prospects may be fading for additional reforms. [MORE]

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Advocates for Medicaid seniors wary of assigned drug coverage

By Susan Jaffe  |  Plain Dealer Reporter | December 29, 2005

Under the Medicare prescription drug benefit, the federal government enrolled millions of the nation’s poorest and sickest seniors into private drug plans that may not cover all their drugs. [Continued here.]