Nursing homes are protesting draft recommendations, approved by Congress' Medicare payment advisors Friday (Jan. 13), that would eliminate the market basket update for nursing homes, which the industry says would cut pay at least by 4 percent, would revise the nursing home pay system for 2013 and would begin rebasing pay in 2014, with an initial reduction of 4 percent and subsequent reductions.

On the same day that Premier announced its QUEST initiative saved more than 24,000 lives and nearly $4.5 billion over three years, the Congressional Budget Office said Medicare demonstrations that build on the kind of data sharing and medical-practices development engendered by QUEST showed no evidence of reducing Medicare spending.

FDA will likely continue to revamp the medical device 510(k) clearance pathway this year, with the agency issuing major draft guidance documents late last year that could have profound effects on industry, sources said.

The dietary supplement industry is turning its attention toward ensuring company compliance with current good manufacturing practices as FDA has started issuing warning letters.

The grocery store and food manufacturing industry said the food safety law's new requirements, particularly foreign supplier verification and preventive controls, could delay the production and transport of packaged food this year, as retailers hope to avoid new transportation requirements.

Hospitals continue to lobby against several policies in play that would offset the cost of extending the physician pay patch until the end of the calendar year or beyond as a key Democratic House lawmaker signals hope that a final conference agreement will be agreed upon by the end of the month.

States would have the statutory authority to establish a “Very Integrated Program (VIP)” that would use managed care plans to provide all Medicare and Medicaid services to beneficiaries eligible for both programs, under a proposal by the Association for Community Affiliated Plans (ACAP) that has caught the attention of state Medicaid officials.

Advocates want HHS to publicly release specific information on the current large-enrollment plans that could be used by a state to define the health reform law's essential health benefits, saying in a December letter that the information would provide more certainty about the practical impact of HHS' intended regulatory approach with respect to EHB that was outlined last month in a bulletin.

A group of House Democratic lawmakers is probing whether reimbursement of attention deficit disorder (ADD) drugs are contributing to shortages of these medications, while also questioning the effect of the Drug Enforcement Administration's quota system -- an amount that caps how much of a drug a company can manufacture.

Several Republican lawmakers are chiding HHS for having issued a “bulletin” instead of a proposed rule on the health reform law's essential health benefits, saying the move is “the antithesis of an 'open and transparent' process,” according to a Jan. 13 letter the lawmakers sent to HHS Secretary Kathleen Sebelius.

The administration continues to review internally biosimilars guidance that FDA officials had hoped to issue by the end of 2011, and industry stakeholders now expect to see the document before Congress starts debate on a user fee package as the document could supplement the agency’s case for fees to support the health reform law's new approval pathway.

Physicians surveyed as part of congressional investigators' probe into pediatric medical device development said they face challenges in obtaining public and private payor coverage of humanitarian use devices, including that insurers sometimes consider such devices to be experimental.

In the wake of recent issues raised by FDA and some in industry, stakeholders are reconsidering a legislative proposal for a progressive approval pathway -- which supporters say would harness regulatory tools to expedite product approvals -- with several sources saying that major modifications are being mulled, potentially reducing the proposal's initial scope.

Stakeholders said the delays in rules required under the Food Safety Modernization Act and currently under review by the White House Office of Management and Budget are likely due to the size and financial impact of the regulations, which are thought to be the cornerstone of the landmark law.

MedPAC on Thursday (Jan. 12) approved controversial draft recommendations to reduce pay for evaluation and maintenance (E/M) services that are provided in outpatient departments so they are equal to pay rates for those same services provided in doctor offices, a controversial proposal that the House used to help offset its two-year physician pay fix in December and will likely come up again as congressional conferees revisit 'doc fix' legislation.

The U.S. Chamber of Commerce says lawmakers must be willing to make adjustments to entitlement programs and has placed Medicare and Medicaid reform atop its agenda, which, in a noticeable shift from last year, does not mention a position on any provisions in the health law.

FDA and industry device user fee negotiators are considering a funding bump for the last three years of the five-year user fee program, provided the agency meets its performance goals for the first two years, according to newly released meeting minutes.

The medical device industry’s top lobby group met with FDA Commissioner Margaret Hamburg a month before FDA's looming Jan. 15 deadline for submitting a device user fee agreement to Congress, and industry sources not directly involved in the meeting expressed concern that Hamburg would reiterate the case for higher user fees and also has the leverage to send a user fee package to Congress without industry’s blessing.

HHS' second move under the health reform law to deem an insurer's rate increases “unreasonable” were protested by the insurer involved, and sparked renewed calls from the insurance industry trade group for the government to look beyond premiums and consider all factors behind rate hikes.

The House Energy and Commerce health subcommittee on Thursday unveiled plans to hold hearings next month on the four FDA user fee programs, including a newly proposed fee on biosimilars products emanating from the health reform law -- with top agency officials slated to testify at each of the three hearings.