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Daily News

January 18, 2002

A major conservative think-tank has issued a report on homeland security calling for Congress to amend the Public Health Service Act to allow FDA to approve generic biologics as a way to help the country prepare for possible bioterrorist attacks. The Heritage Foundation's recommendation came as a surprise to key biotechnology industry source, who says he does not think Heritage consulted with the biotech industry as it wrote the report.

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January 17, 2002

A Medicare coverage request submitted to CMS a year ago was misplaced and the agency is just now reviewing the merits of the application to cover a certain type of cardiac event recorder, according to several sources and documents obtained by Inside CMS. The agency has yet to post the request on its website and the mishap has some stakeholders questioning the CMS filing system for coverage issues.

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Four years after its secretive Medicare coverage advisory panel was found to be in violation of federal committee rules, CMS is now planning an invitation-only stakeholder meeting to discuss the workings of the panel's successor, the Medicare Coverage Advisory Committee (MCAC). Some experts say the upcoming meeting could violate the very same rules that led to the disbandment of the earlier panel.

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A national association of electrical manufacturers hopes to convince the newly formed HHS regulatory reform panel to recommend CMS grant "interim" coverage of medical technologies as coverage applicants continue to collect certain data requested by the agency. The association is drafting a white paper on CMS' coverage and payment policies that it hopes to present to a key HHS advisory panel in early March.

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Consumer advocates lashed out at the first meeting of an HHS regulatory reform panel, claiming the Bush administration has compiled a panel that is heavily skewed toward industry and provider groups. HHS Secretary Tommy Thompson has suggested he will add patient advocates to the committee but beneficiary representatives say these proposed moves fall way short.

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CMS is considering scaling back Medicare coverage of clinical trial costs and may unveil a rule this year that would rescind some of the policies issued by the Clinton administration, according to sources. Such a move would be highly controversial and trigger strong opposition from key lawmakers, patient advocates, and medical device groups.

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State and hospital groups are vowing to continue their fight against CMS' proposal to slash a controversial Medicaid upper payment limit (UPL), and plan to reignite their lobbying efforts when Congress returns.

Despite the financial and political obstacles, lobbyists have not given up hope for a legislative moratorium to block CMS' proposed rule to reduce a current 150 percent UPL for safety-net hospitals. CMS plans to reduce the UPL to 100 percent, claiming the current limit is a loophole for further funding abuse.

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The nation's largest hospital groups are pleading with President Bush to reject reductions to Medicare and Medicaid funding when preparing his budget blueprint for fiscal year 2003. In a Jan. 16 letter (available on IWP Extra) to Bush, the groups pointed out that more than one-third of all hospitals are losing money on Medicare with another third barely breaking even. The groups ask the administration to "restore funding to vital programs that are scheduled to experience further cuts in 2003...."

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One of the nation's largest nursing home operators has agreed, after years of legal wrangling, to implement measures to reduce back injuries, purchase lift equipment and create a training program for employees as part of a settlement agreement with OSHA and a health care union.

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January 11, 2002

To the chagrin of the pharmaceutical industry, Alastair Wood, the assistant vice chancellor at Vanderbilt University, is the current favorite to fill the FDA commissioner slot, sources say. But it may be difficult for the drug industry to object now as the slot has been open for a year and the Bush administration is beginning to face criticism for its slowness in filling the position. If Wood is nominated it would be even more difficult for the drug industry to block him, adds a source, because Sen.

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FDA is considering asking the food industry to use tamper-evident packaging and to compile records that trace food shipments to ensure the safety of the food supply, but wants to hear advice from stakeholders before making a final decision. The agency issued two guidance documents this week laying out several other ways the food industry could prevent tampering of food, but punted on whether to also recommend tamper-evident packaging and food shipment tracing.

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Fearful of contaminating the blood supply with variant Creutzfeldt-Jakob Disease (vCJD), the human form of mad cow disease, FDA issued a revised guidance this week further reducing the number of people who can donate blood and blood components. The agency now recommends blood facilities defer blood and plasma donors who have traveled or resided in the United Kingdom for a cumulative period of three or more months between 1980 and 1996, and also tightens other donor deferral restrictions. In its previous guidance, the agency had recommended a cut-off date of six months.

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