FDA Commissioner Margaret Hamburg signaled to House lawmakers Wednesday (Feb. 1) that the agency does not need a legislative fix to address conflict-of-interest policies that may be contributing to problems with filling vacant positions on advisory committees, saying the agency is engaging stakeholders on the issue and regulatory science collaborations could also provide FDA with needed expertise.

The National Association of Chain Drug Stores is lobbying congressional conferees against moving retail pharmacies into the competitive bidding process for diabetic testing supplies as a way to pay for overriding a physician pay cut under the Sustainable Growth Rate (SGR) formula.

Rep. Nan Hayworth (R-NY), a conferee negotiating on the Medicare physician payment fix, told Inside Health Policy that she is open to counting a reduction in war spending as an offset for permanently replacing the Sustainable Growth Rate formula.

Representatives of industry groups including the Blue Cross and Blue Shield Association and the U.S. Chamber of Commerce provided White House officials at a Jan. 27 meeting documents that called for a delay in implementation of the health reform law's summary of benefits and coverage requirements and an exemption for large groups including those that self-insure, with the groups pushing for at least 18 months after final regulations are released to come into compliance.

With a tentative device user fee agreement now in hand, FDA is urging industry negotiators to “remain committed” to the deal as the device industry trade group signaled Wednesday (Feb. 1) it may support additional reforms as the proposal moves through Capitol Hill.

Hospitals are siding with consumer advocates on many issues surrounding HHS' efforts to implement the health reform law's essential health benefits requirements, with consumer groups expressing strong disagreement with the insurer benefit design flexibility outlined in the department's December guidance and several groups calling on HHS to define the scope and services within each of the health law's 10 benefit categories.

A health reform law fee that will be levied against insurance companies starting in 2014 will cost state Medicaid programs $38.4 billion over a decade because Medicaid will pay the portion of the fee assessed against Medicaid managed care organizations, a Milliman report commissioned by the Medicaid Health Plans of America has found.

Bipartisan House legislation introduced Tuesday (Jan. 31) would expedite FDA review of medications in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration quotas for medications in short supply.

Consumer testing conducted by Consumers Union shows a need for standardization of health plans, and also finds that several tools such as “coverage examples” and actuarial tiers can help consumers make better choices about purchasing health plans, according to Lynn Quincy, who penned an brief about the testing.

There are still plenty of war savings left that could be used to pay for fixing the Medicare physician pay formula, according to the 2012 budget outlook that the Congressional Budget Office released Tuesday morning (Jan. 31), bolstering calls by providers for a permanent Sustainable Growth Rate fix paid for with savings from troop drawdowns.

Stakeholders are questioning the allocation of FDA priorities in light of alleged whistleblower monitoring activities, including agency access to employees' personal email accounts and computer screenshots, with a key Senate whistleblower advocate saying the agency should reassure employees that they can interact with Congress about government wrongdoings.

Some states are considering requiring that “high-risk” Medicaid providers enroll in Medicare as a way to lessen the administrative burden of implementing new provider-screening and enrollment rules, a state Medicaid source tells Inside Health Policy.

HHS has sent to OMB a prerule that will offer guidance on the actuarial value and cost-sharing reduction provisions of the health reform law, marking the second time in recent months that the administration has chosen to release a “bulletin” of a health reform law provision rather than a proposed rule.

FDA is pushing ahead with its innovation pathway for novel medical devices with a pilot project for end-stage renal disease that one stakeholder said could provide inroads to comparative effectiveness research and despite calls from the medical device industry for the agency to focus on bringing greater efficiency and consistency to the overall review process.

A new shared Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl (TIRF) products could serve as a model for FDA as it determines and develops other class-wide REMS, with the agency possibly subdividing programs for classes of drugs by patient population, administration and other characteristics, according to an industry attorney.

Some physician groups are lobbying against legislation that would make continuing medical education mandatory for opioid prescribers, saying such a mandate could restrict access to these products by creating a burden on doctors.

Medicare Part D costs factored into the Federal Trade Commission's move Friday (Jan. 27) to take steps to block long term care pharmacy Omnicare's proposed acquisition of rival PharMerica, with FTC saying the planned merger would diminish competition and result in higher health care costs for Medicare Part D and other consumers as the resulting entity would have unparalleled negotiation powers over plan sponsors.

Following months of pressure from pharmacies, CMS issued a proposed rule on Friday (Jan. 27) that explains how drug makers should calculate Average Manufacturer Prices (AMPs), which in turn is used to determine caps on Medicaid generic-drug reimbursement, called Federal Upper Limits (FULs).

Free speech advocates are using a district court case as an opportunity to challenge FDA guidance released last year outlining the difference between drugs and devices, with the advocates saying the agency's policy conflicts with the statutory definition of medical devices.

Industry stakeholders said an FDA-regulated system for front-of-package labels could limit free speech if such an approach banned companies from using other labeling systems, and a free speech advocate said the agency could only bar companies from using labels if it found they listed misleading information.