CMS rebutted the hospital lobby argument against a 2.9 percent cut to the inpatient prospective payment system (IPPS) that the agency says is needed to offset the so-called “coding creep” caused by the Medicare Severity Diagnosis Related Group (MS DRG) policy.

The Generic Pharmaceutical Association membership approved changes late last week to the group's governance structure that will provide larger firms with more clout, a move that could entice drug industry giant Teva to return to the organization and help provide a more unified industry voice as FDA moves forward on establishing generic drug user fees, according to several informed sources.

The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives outlined in an HHS report released last month, according to documents recently sent to Capitol Hill.

Key stakeholders are questioning why HHS' planning shop has moved to build an inventory of comparative effective research (CER) prior to the establishment of independent CER that was created under the health reform law.

A key Democratic lawmaker and some consumer advocates are raising concerns with FDA's communication to the public during the recent salmonella outbreak that prompted a massive egg recall.

FDA's new agency-wide metrics program has improved accountability and will help track the implementation of new statutory authorities as the publicly accessible performance measurement system continues to aggregate more data, according to a top agency official.

Democratic lawmakers in Minnesota are discussing whether to sue Gov. Tim Pawlenty (R) for standing by his pledge not to apply for federal health reform funds despite a state law calling for him to apply for a $1 million federal insurance exchange grant, state lawmakers told Inside Health Reform.

A pilot program to jointly inspect drug manufacturing facilities recently launched by FDA and its European Union counterpart could set the groundwork for further opening U.S. borders to drugs manufactured or stored abroad by harmonizing safety standards, sources said.

HHS Secretary Kathleen Sebelius and members of a Minnesota health reform task force lashed out at GOP Gov. Tim Pawlenty on Tuesday, after hearing that the 2012 presidential hopeful had issued an executive order blocking state agencies from applying for federal funding to help implement the health reform law.

CMS refused to give lawmakers the list of winning bidders for the first round of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) program and took a swipe at the industry by reminding suppliers that the suppliers had originally asked that the names of the winners be kept secret, even though the industry now wants the list released.

Almost 2,000 employers have been accepted into the Early Retiree Reinsurance Program, including large and small businesses, state and municipal governments, colleges, non-profits and unions, according to an e-mail blast to congressional staff sent early Tuesday by the HHS assistant secretary for legislation.

Denied access to the stimulus law's health IT bonus payments for each campus of their hospital systems, some hospitals are applying for additional CMS Certification Numbers (CCNs) to create separate hospitals so they can receive more than one incentive payment for installing electronic health records, an industry source says.

This month’s massive egg recall for salmonella contamination may create momentum for the much delayed Senate version of a bill aimed to improve safety of food products manufactured in and imported into the United States by giving FDA more power to call for mandatory recalls, increase facility inspections and better identify the source of the outbreak, according to food safety advocates.

The recently unveiled Senate food safety managers package includes several provisions that fall short of the hopes of some consumer advocates, who intend to lobby for changes to the legislation that would make the bill more closely mirror the House language, focusing their efforts on the frequency of inspections, defining some critical terminology and ensuring that facility exemptions are not eventually added to the measure.

The Senate's HHS appropriations bill includes an unrequested $40 million to expand medical home demonstration programs called for in the health overhaul law and gives the agency just 90 days to get those demonstrations underway.

A bipartisan group of 136 House lawmakers requested this month that CMS disclose the medical equipment providers whose bids were used to calculate home medical equipment reimbursement rates under Medicare's competitive bidding program.

Two recent events indicate that the government will continue to make off-label marketing a priority in fighting health care fraud as the Justice Department goes through a backlog of whistleblower cases against drug companies, fraud lawyers say.

How reimbursement will ultimately be doled out under what is arguably the central delivery-system reform in the health care law -- accountable care organizations -- has been the subject of behind-the-scenes lobbying by lawmakers who want CMS to use its authority to consider the wide variation in quality as it devises a policy aimed at enticing providers to form or join ACOs.

A bipartisan group of Senate lawmakers hope to expand the scope of a little-used tropical disease drug voucher program to also encompass pediatric orphan products, although the initiative has been minimally successful thus far and it remains unclear whether an expansion would substantially encourage manufacturers to develop these products because the market value of the voucher remains unknown, sources said.

OSHA, along with key labor and worker safety groups, are increasingly looking to use EPA's environmental statutes to bolster occupational safety, including the proposal of worker protection measures as key provisions in bills to reform the Toxic Substances Control Act (TSCA).