State regulators are making a new argument aimed at bypassing Environmental Protection Agency (EPA) concerns that regulating workplace exposure to indoor air toxics stemming from underground contamination would preempt OSHA standards, according to EPA and state sources.

CMS is accepting nominations until Friday (March 12) for members of a commission to help guide the agency in coordinating the Medicare prescription drug benefit with existing state pharmaceutical assistance programs for low income seniors.

Sen. Orrin Hatch (R-UT) is pressing CMS to finish up a review of the new Medicare payment system for physicians treating dialysis patients, raising concern that rural practitioners may be disadvantaged by linking reimbursement to multiple face-to-face visits.

A health economist is cool to the idea of requiring other countries to shoulder more of the burden of drug research and development costs.

CMS administrator nominee Mark McClellan promised Monday (March 8) at his Senate confirmation hearing to work with lawmakers on a reimportation bill.

The House Energy and Commerce Committee will oversee implementation of the new Medicare reform law as one of its top health care priorities, the panel’s new chairman Joe Barton (R-TX) has announced.

The Bush administration has announced plans to screen all federally funded biological research and to monitor journal articles and public presentations of such research to block sensitive information from getting into terrorists’ hands. HHS is launching a national board that will include up to 40 members.

Members of a key House panel are focusing on state monitoring programs as a way to track and counter prescription drug diversion. Panel members discussed the merits of federally mandating that states set up a monitoring program that would track prescriptions for controlled substances.

Brand-name drug company Schering-Plough and generic competitor Upsher-Smith are appealing a recent ruling by the Federal Trade Commission that the companies’ “reverse payment” settlement was anticompetitive.

CMS last week raised hospital reimbursements for intravenous immune globulin (IVIG) in response to complaints from stakeholders, who have begun to push the agency to boost physician and home infusion provider payments for the life-sustaining substance, arguing that Congress intended to exempt the life-sustaining from the Medicare law’s cuts to the average wholesale price reforms.

With congressional estimators predicting sharp cuts to Medicare physician reimbursements starting in 2006, the House Ways and Means Committee is planning a series of hearings to investigate problems with the physician update formula in anticipation of a possible legislative fix in 2006, congressional sources said.

CMS will miss a March 7 deadline for setting up an interim drug coverage program established by the Medicare Modernization Act and will not tally the savings on currently-covered drugs to stretch the program’s $500 million budget as lawmakers had demanded, House and industry sources told Inside CMS

The dietary supplement industry and the food industry are split on whether FDA should provide incentives to spur manufacturers to develop the data needed to obtain significant scientific agreement for an unqualified health claim.

Gillian Woollett, who headed the science and regulatory affairs shop at the Biotechnology Industry Organization, abruptly left from the organization last Friday (Feb. 27), in part because she and her boss Michael Werner disagreed over how to handle generic biologics, biotech industry sources say.

House Republicans have failed to ax a provision of device reform law that requires both device manufacturers and hospitals that reuse single-use devices to mark products with their company name or logo, according to a congressional source.

FDA has already started work on a draft guidance that will advise drug manufacturers how to notify FDA if they plan to make changes to their drugs to incorporate authentication technology such as taggants to help stem counterfeits, according to an FDA official.

FDA has given Wal-Mart and Accenture the go-ahead to explore the use of radiofrequency identification technology (RFID) tags on drugs, according to an agency official.

The cosmetics industry trade group is asking FDA for more time to implement changes to production techniques so that industry can comply with FDA’s new interim final rule, which goes into effect immediately, to prevent the spread of mad cow disease.

Protecting workers from mold exposure is a burgeoning issue among safety organizations and state legislatures. During a Feb. 17 conference call sponsored by the American Society of Safety Engineers (ASSE), safety professionals highlighted current efforts to block potential health hazards in workers stemming from mold exposure.

CMS is still weighing how it will decide two key questions for its upcoming proposed rule on the Medicare prescription drug benefit -- whether it will require more than one drug in each therapeutic class in drug plan formularies and whether the legislation legally bars it from negotiating on prices and formularies if there are government-run fall-back plans.