The National Association of Insurance Commissioners subgroup tasked by the health reform law to recommend revisions to the two most popular Medigap plans generally agrees that advanced imaging and durable medical equipment are two services that should be considered as candidates for cost-sharing, according to discussions the subgroup had during a conference call this week.

Republican Sens. Tom Coburn (OK) and Scott Brown (MA) have asked CMS Acting Administrator Marilyn Tavenner if CMS is utilizing free online applications, such as Google Earth, to determine if a billing address actually exists, and also want to know which unimplemented HHS OIG and GAO fraud-fighting recommendations the agency is considering.

A key advocate of physician reporting backs CMS' recent decision to delay when drug and medical device makers must begin collecting information on the gifts that they give doctors and teaching hospitals, but he is pushing CMS to maintain the law's 2013 start date for reporting that information.

As the food industry prepares for the release of four new FDA regulations, two agency-sponsored alliances are focusing on ways to improve training of food safety inspectors as well as farmers, food growers and others in the industry to comply with the upcoming regulations.

The idea of a progressive FDA approval pathway -- expedited approvals for products aimed at a specific patient population -- is gaining traction on Capitol Hill and among investors, who say the current accelerated pathway needs updating.

Staff for House Ways and Means Chair Dave Camp (R-MI) and Senate Finance Chair Max Baucus (D-MT) on Wednesday (Jan. 11) convened a bipartisan, bicameral meeting of staffers for conferees working on legislation to override Medicare physician pay cuts and extend payroll-tax cuts and unemployment insurance, according to a House aide.

The Congressional Research Service warned lawmakers that raising physician pay in a “doc fix” by allowing for greater Medicare expenditures likely would also mean raising premiums for many seniors, according to a late-December CRS report obtained by Inside Health Policy that outlines options for replacing the Sustainable Growth Rate formula that sets Medicare pay rates for physicians.

GOP governors or attorneys general in 26 states are telling the Supreme Court that the health reform law's Medicaid expansion is unconstitutionally coercive and argue the program's expansion was constructed to help fulfill what they also view as the law's unconstitutional individual mandate, according to the brief filed to the Supreme Court Tuesday (Jan. 10) by those governors who are also challenging the entire health reform law.

A bipartisan group of 14 senators is pressing CMS to hold off distributing draft lists of maximums that the federal government will offer state Medicaid programs for generic drugs until the CMS drafts a regulation explaining how it calculates those Federal Upper Limits.

Advocacy group Families USA on Tuesday (Jan. 10) unveiled two new reports that aim to provide state-based consumer advocates a roadmap for monitoring state efforts to institute accountable care organizations and other delivery system reforms, and the group lays out specific questions it says advocates should ask to ensure ACOs in their area are committed to providing coordinated services that not only lower cost but also improve care.

The House Energy and Commerce Committee's top Democrats are calling on FDA to make third-party food audit reforms, saying an auditing firm tied to the recent Listeria outbreak in cantaloupe did not follow FDA guidance or report violations to authorities and had inherent conflicts of interest.

A coalition with broad participation from pharmaceutical companies is committed to adding clarity around FDA's social media policies in 2012, which is expected to be a significant year for the agency's promotional policies as stakeholders digest newly released FDA guidance that hints at a restrictive approach limiting what companies can say publicly, including online.

Medical device stakeholders said changes to the de novo approval process and conflict of interest rules are legislative reforms that will likely ride along with user fee legislation, while other device reforms could also be included in the agreement being negotiated by FDA and industry.

CLASS proponents are working behind the scenes to come up with alternative ways to carry out the reform law's voluntary long-term care insurance program's mission, with one source saying some policy discussions are honing in on Medicaid.

A Senate lawmaker is questioning why FDA has not extended Risk Evaluation and Mitigation Strategies to short-acting opioids, and urged the agency to consider requiring radiofrequency identification technology and stronger postmarket surveillance for pure hydrocodone drugs, which are in development and said to be stronger than painkillers currently on the market.

FDA recently delved into two areas of off-label promotion policies leading into a year that could have broad implications for the agency's stance in this area, with FDA's efforts potentially adding clarity to issues raised by industry, sources said.

The Biotechnology Industry Organization is turning its attention toward building consensus around policy issues that could be attached to reauthorization of the Prescription Drug User Fee Act and initiation of other user fees, as FDA drug fee negotiations are complete and industry groups vie for swift passage, an issue central to the industry's lobbying efforts in 2012.

FDA weighed the potential for drug shortages, medical necessity and pharmacist involvement as it recommended against recalling prescription opiates that were part of a packaging mix-up that could result in the painkilling medication ending up in the bottle of another product, and the drug maker urged doctors not to start new patients on the drug to ensure adequate supply.

The hospital industry is asking the Supreme Court to ax the reform law's Medicare and Medicaid cuts if the individual mandate is found unconstitutional.

The Department of Justice is sticking with its argument that the health reform law's individual mandate provision operates as a tax law, even though that argument has not taken hold in lower courts, as a part of its defense of the mandate in a brief filed with the Supreme Court Friday (Jan. 6).