Expert: Studies that guide regulations should be more accountable | CMS administrator: No plans to reintroduce withdrawn Part D proposals | More insurers will offer health plans on exchanges for 2015
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September 24, 2014
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Expert: Studies that guide regulations should be more accountable
Federal agencies increasingly rely on studies performed by third-party organizations and contractors to make rules and policies, including those for Medicare Advantage and Part D. As regulatory action takes precedence over legislative action, more transparency is needed in the internal processes federal agencies use to perform and outsource research in support of rulemaking initiatives, attorney William Schiffbauer writes. "Greater accountability in the conduct of studies and research used to inform agencies for purposes of rulemaking will introduce important and now lacking checks and balances between appointed federal agency heads and any disparate 'agenda' of career agency staff that might structure a study to support a particular public policy result," Schiffbauer says. Bloomberg Government (subscription required) (9/23)
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CMS administrator: No plans to reintroduce withdrawn Part D proposals
CMS Administrator Marilyn Tavenner said she is not interested in reintroducing withdrawn proposed rules to open preferred networks in Medicare Part D plans, reinterpret the law's noninterference clause, limit the number of plans carriers could offer in a given market and reduce the number of preferred drug classes. (subscription required) (9/23)
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Legislative & Regulatory News
More insurers will offer health plans on exchanges for 2015
The number of insurers offering health insurance plans on public exchanges will be 25% higher for 2015 than for 2014, with competition keeping premiums down, according to an HHS report. Though some insurers have left some markets, 63 more organizations will participate in the 44 states for which HHS has data, and 248 issuers will sell coverage on, the department said. Reuters (9/23), The New York Times (tiered subscription model) (9/23)
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FDA's Mini-Sentinel to become fully developed project in Oct.
The FDA's Mini-Sentinel pilot project to evaluate the safety of drugs through the EHRs of more than 175 million people will become a full initiative on Oct. 1. University of Washington epidemiologist Bruce Psaty said challenges remain, including who should publicize and analyze the findings and how they should be weighed against other safety information. Nature (free content) (9/23)
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Drug Industry Spotlight
Some pharma deals may be put off after U.S. clampdown on inversions
A U.S. crackdown on tax inversions could discourage some pharmaceutical mergers that depend on tax savings to be viable. A new restriction will make it more difficult to access tax-free cash trapped overseas, and foreign-based companies could find it hard to borrow from the units of acquired U.S. firms. The New York Times (tiered subscription model)/DealBook blog (9/23)
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True happiness is ... to enjoy the present, without anxious dependence upon the future."
-- Seneca,
Roman philosopher and playwright
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About PCMA
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 216 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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