Food safety advocacy groups have filed the first-ever lawsuit urging the government to regulate the potential health and safety risks of nanotechnology, requesting the court force FDA to answer their six-year-old citizen petition demanding FDA start regulating the use of unlabeled nanomaterials in consumer products.

A coalition of imaging stakeholders is calling on Congress to reject the Radiology Benefit Manager industry's request that lawmakers consider implementing prior authorization programs for outpatient imaging services to control costs.

A pharmacy stakeholder group signaled it would be interested in renewing discussions with FDA about creating an intermediate class of drugs following recent comments by a top agency official about the possible need for behind-the-counter medicines in light of the administration's decision on Plan B.

CMS unveiled much-anticipated urging CMS to move forward with the initiative.

A stakeholder group advocating interests of patients with chronic conditions and disabilities says HHS should pursue an alternative process to develop essential health benefits that includes gauging the package's affordability through a target cost of benefits rather than using a national premium target as a guide, the latter of which was recommended by the Institute of Medicine.

Future congressional action on a Medicare physician payment fix and other extenders is in flux following the House's 229-193 rejection Tuesday (Dec. 20) of the Senate's two-year payment patch, but sources suggest the House may come back Jan. 3, rather than Jan. 17, and some say its possible that backroom negotiations could lead to an acceptable compromise before the impact of Congress' failure to act are felt even as the parties continue to lob insults.

Seven biosimilar investigational new drug (IND) applications have been filed with FDA, and the agency has received 31 pre-IND requests and held 21 pre-IND meetings with sponsors of these follow-on biologics, in addition to other meetings with companies involved with the healthcare reform-created pathway, according to the director of FDA's biosimilars group, giving the first public insight into the pace and volume of the biosimilar program at the agency. Some stakeholders expressed surprise that the numbers were so high this early in the program.

Environmental, food safety and consumer groups are calling on FDA to suspend any steps it has taken toward approval of AquaBounty's genetically engineered salmon, release all health data on the product and conduct an Environmental Impact Statement following a discovery that the facility rearing the fish had problems with an infectious disease in 2009.

Efforts by children's hospitals to get the Senate to reauthorize the Children's Hospital Graduate Medical Education (CHGME) Payment Program for five years have hit a snag, with sources saying the legislation has not moved to the Senate floor because of a desire from Sen. Sheldon Whitehouse (D-RI) to make certain children's psychiatric hospitals eligible for the funding.

House GOP leaders have scrapped a vote on the Senate's two-month doc fix legislation and instead plan to vote Tuesday (Dec. 20) on a “motion to reject” the upper chamber's bill, confidently predicting the motion will pass. They called for longer extensions of Medicare physician payments, the current payroll tax rate and unemployment insurance that are wrapped into the Senate package.

The highly controversial Medicare reform plan unveiled by Sen. Ron Wyden (D-OR) and Rep. Paul Ryan (R-WI) last week would give seniors the choice of staying in traditional fee-for-service or choosing a plan from a newly created Medicare exchange, but the duo deflected questions about how the plan would build on the insurance exchanges created by the Affordable Care Act, indicating that the controversial law that the senator supports and the congressman wants to repeal stayed off the table during their deliberations on the proposal.

Sen. Ron Wyden's office is hitting back against criticism from the White House, some Democratic House members and left-leaning stakeholders who charged that the bipartisan Medicare reform proposal he unveiled last week along with Rep. Paul Ryan (R-WI) would create adverse selection and ultimately end the program.

CMS has chosen 32 health care systems to participate in its Pioneer ACO demonstration, projected to save Medicare $1.1 billion, out of 80 applicants that had been part of a group of some 160 systems that signed letters of intent, CMS officials said Monday (Dec. 19).

FDA officials Monday (Dec. 19) gave preliminary estimates of generic drug user fees -- saying abbreviated new drug applications could cost around $60,000, although the final amounts will vary depending on how many drug master files, facilities and backlogged applications are included in the program -- with the numbers expected to be flushed out in a series of Federal Register notices if Congress passes the agreement.

CMS has notified physicians that it will hold payments until Jan. 17, the day the House returns from its holiday break, in an effort to avoid a 27.4 percent cut should Congress fail to delay the Sustainable Growth Rate reduction from taking place on Jan. 1.

Senate leadership warns it will not reopen talks on a physician payment patch if House Speaker John Boehner (R-OH) follows through with plans for the House to vote down the Senate's two-month extension Monday night, but a key House Republican hinted over the weekend that the so-called “doc fix” possibly could be pursued outside the broader payroll tax bill and signaled GOP willingness to weigh non-Medicare and non-health reform offsets for a longer-term patch. Late Monday, the House decided to put off its vote on the Senate bill until Tuesday (see related story).

HHS' new bulletin on essential health benefits makes it possible for states to initially include state benefit mandates in their EHB packages and therefore not be required to cover their costs, something advocates seem to be encouraged by but that the insurance industry has concerns with because state benefit mandates are not always subject to rigorous cost analysis or evidence-based reviews.

Republican efforts to chop $8.6 billion in health reform law funding have faltered but a bipartisan fiscal 2012 appropriations bill that passed the House on Friday (Dec. 16) slashes two-thirds of the funding set aside for the controversial Independent Payment Advisory Board and trims funding for the law's CO-OP program.

The Biotechnology Industry Association and Pharmaceutical Research and Manufacturers of America are calling for the eventual elimination of a development fee aimed at funding FDA’s initial biosimilar review activities while the biosimilars industry is still in its beginning stages, with the groups saying it is a “stop-gap” measure and should not set a precedent for a similar fee for drug development.

Congress' Medicare payment advisors on Friday (Dec. 16) discussed draft 2013 recommendations to freeze Medicare pay for long term care hospitals (LTCHs) and inpatient rehabilitation facilities (IRFs), and increase the pay rate for hospice services by 0.5 percent.