Despite what sources view as ever-lengthening odds, nearly 70 provider trade associations sent a letter Monday (Jan. 23) to Rep. Dave Camp (R-MI) pleading for a permanent repeal of the Medicare Sustainable Growth Rate formula by counting a reduction in war funding as payment for the growing cost of replacing the Medicare physician pay system.

Biotechnology Industry Organization officials said Monday (Jan. 23) that they are shifting their focus toward reforming FDA's accelerated approval process, a departure from the creation of a new progressive approval pathway, which was met with some opposition from FDA and some in industry.

The health reform law's comparative effectiveness research advisory board unveiled a draft research agenda that does not include specific conditions or treatments, opting instead to outline general, vaguely worded research topics.

Alaska Sen. Mark Begich (D) praises his state's new movement towards establishing a state-based exchange but tells Inside Health Policy he is “concerned with the slow pace of implementation and believe(s) it is unfortunate that Alaska missed out on no-strings-attached federal funding that would have covered the expense of planning an exchange.”

Multi-specialty medical groups are urging congressional conferees to hammer out a longer-term Medicare physician payment solution that takes physician practice costs into account and rewards providers for delivering quality care.

Major health reform rules HHS will finalize this fiscal year include those on the establishment of exchanges, state requirements for exchange reinsurance and risk adjustment and the Medicaid eligibility expansion, according to HHS' newly unveiled statement of regulatory priorities for fiscal year 2012, but the statement makes no explicit reference to regulations on the highly anticipated essential health benefits as a priority for the coming months.

Democratic leaders of the House Energy and Commerce Committee on Friday renewed their call for hearings to examine the safety of implantable medical devices ahead of reauthorization of medical device user fees, an area where safety advocates are pushing for a more rigorous premarket approval process.

The Occupational Safety and Health Administration (OSHA) says it would have “serious policy concerns” if HHS opts to promote mandatory health care worker vaccination for influenza, saying OSHA strongly supports efforts to increase the vaccination rates but does not believe the evidence is sufficient to back requirements that could result in workers being fired.

Consumer advocates and community pharmacists say the Federal Trade Commission's recent settlement with CVS Caremark over mispriced drugs on CVS' Medicare Part D list demonstrates the need for legislation requiring pharmacy benefit managers to disclose more information about deals between PBMs and drug companies.

Food safety advocates say the threat of mandatory recalls has helped the agency convince companies to more quickly agree to voluntary recalls during the first year of the Food Safety Modernization Act.

The medical device appeals process will likely remain burdensome for industry despite draft guidance recently released by FDA seeking to clarify this area, industry sources said, some of whom are advocating for creation of a separate office of appeals and an overhaul of the entire appeals process.

A coalition of advocacy groups prodding FDA to take action on animal antibiotic restriction policies is expanding its legal challenge to include the recent denial of citizen petitions asking the agency to restrict the use of animal antimicrobials, as the agency defends its ability to refrain from finishing actions proposed in the 1970s to withdraw the approval of two animal antibiotics, according to recent court filings in the months-long legal challenge.

Officials involved in health reform efforts from seven states are pushing HHS to provide detailed information on the specifications of a federally-run exchange, including governance, consumer functions, eligibility and financial management, according to a Jan. 11 letter obtained by Inside Health Policy.

Nineteen hospital groups are urging the president to use his budget proposal to fix a measure in the health reform law that they say benefits a single state, Massachusetts, at the expense of the rest of the states.

Several sources expect that the Federal Trade Commission (FTC) will make a decision shortly on a proposed merger of the nation's leading long-term care pharmacies, and will most likely block or restrict Omnicare, Inc.'s planned takeover of PharMerica Corp. due to concerns over competition as well as the impact on prescription drug plans.

As congressional conferees begin formal talks Tuesday (Jan. 24) on a physician payment fix, an upcoming Congressional Budget Office budget baseline could complicate efforts to find budget offsets, hospital lobbyists say.

A top White House Office of Management and Budget Official indicated that consolidating food safety oversight could be tackled under President Barack Obama's new push for streamlining powers from Congress to reorganize government agencies, but stakeholders are doubtful the long-studied idea will gain steam.

A recently released draft guidance document on medical device substantial equivalence -- the heart of FDA's premarket decision making process for 510(k) submissions -- could have broad-reaching implications for industry, shifting the agency's stance on allowing split predicates to reliance on new concepts such as reference devices, according to some sources, who said the so-called 510(k) paradigm guidance could be one of the most important documents the agency's device center released last year.

The White House is pointing to several states' movement toward creating their own exchanges as evidence that health reform is taking hold, yet administration officials on Wednesday (Jan. 18) discussed few details related to the minimum states will have to do in order for HHS to fully certify their exchanges by the start of 2013, and sources say the department has been scant on details regarding conditional exchange approval, a proposal outlined in draft regulations.

Home medical equipment suppliers are trying to get included in doc-fix legislation an alternative to the controversial Medicare competitive bid program, and the industry’s proposal has backing from a key, independent expert on auctions.