Continued industry resistance to FDA's behind-the-scenes press to increase medical device user fees could prevent the two parties from meeting a Jan. 15 deadline to send a commitment letter to Capitol Hill, with stakeholders saying they will work hard to meet the deadline but acknowledge there may be few, if any, consequences if the letter is delayed.

Stakeholders anticipate further FDA action on animal antibiotic policies in 2012, including finalized guidance on judicious use and a rule regarding veterinary oversight, following the agency's landmark decision to ban extralabel use of cephalosporin and its recent withdrawal of a decades-old proposal to pull certain animal antibiotics off the market and instead rely on voluntary policies already underway.

The American Hospital Association is strongly urging HHS not to narrow its use of anti-kickback waivers for accountable care organizations, and is also calling on CMS and the Office of Inspector General to allow the waivers for other programs that seek to coordinate health care among health care providers.

House Minority Leader Nancy Pelosi (D-CA) said Friday (Jan. 6) that seniors deserve to have the confidence that they may see their doctors for “the rest of the year,” possibly signaling that House Democrats will push for a one-year patch to the looming 27.4 percent Medicare physician pay cut.

CMS' newly unveiled interim final rule to standardize the format and data content of health care electronic fund transfers generally hew to recommendations issued by the National Committee on Vital Health and Statistics last February.

Medical device industry officials continue to press for repeal of the health reform law's $20 billion device tax, though some industry stakeholders express apprehensiveness about the chances of Congress passing the costly repeal given the recent showdown over offsets for the payroll tax.

The House Energy and Commerce Committee is expected to consider both economic incentives and regulatory reforms as part of a comprehensive package aimed at stemming drug shortages, according to industry sources who are closely watching for an indication of what solutions to the drug shortage crisis could be included as part of reauthorization of the Prescription Drug User Fee Act this year.

Two key lawmakers and authors of the Dietary Supplement Health and Education Act are urging FDA to immediately withdraw the agency's controversial draft guidance on new dietary ingredients, saying the guidance undermines the balance Congress struck when writing the law.

Most states that have established their exchanges are creating them as quasi-governmental organizations rather than something fully run by the state or nonprofits, something consumer advocates tell Inside Health Policy is a positive development because a quasi-governmental exchange is likely the best model to meet consumer needs.

The Government Accountability Office (GAO) in late December declined to offer an opinion on the Treasury Department's 2011 financial statements on the social insurance trusts primary due to uncertainties in projected reductions in Medicare cost growth.

FDA's ability to respond to drug shortages is constrained by its lack of systemic data and the agency's effort to remedy this problem is not adequate, according to Congress' investigative arm.

Hospitals are disappointed with CMS' newly unveiled Medicare demonstration that allows hospitals to rebill for outpatient services (Part B) when they are denied higher payment for short inpatient stays (Part A), and some are threatening to drop out of the demo if CMS makes them waive appeals rights, as is currently the case.

Although CMS delayed indefinitely a demonstration by recovery audit contractors (RACs) requiring prepayment review of high-risk claims, health care consultants worry that CMS still plans to let Medicare RACs do prepayment reviews -- RACs were designed for post-payment reviews.

Following years-long deliberations and skepticism from GOP lawmakers and drug makers about a scientific link between animal antibiotic use and drug resistance in humans, FDA Wednesday (Jan. 4) issued an order to prohibit certain uses of cephalosporins in cattle, swine, chickens and turkeys, effective April 5.

CMS' decision to reject a for-profit insurance industry proposal and stick with its proposed interpretation of the reform law's “substantially all” requirement, which dictates where Consumer Operated and Oriented Plans (CO-OP) can issue plans, is key to the development of the new nonprofit plans, according to a CO-OP source.

In a stepped-up effort to encourage FDA to exempt convenience and grocery stores from health reform's menu labeling requirements, a bipartisan group of 17 House lawmakers recently touted a report from the White House Office of Management and Budget citing menu labeling as one of the most significant examples of increased regulatory burden in fiscal 2010.

FDA and its European counterpart will start to rely on each others' post-market inspection data starting this month, allowing the agencies to defer or waive GMP inspections of drug and veterinary drug manufacturing facilities in the United States and Europe that are known to both authorities and have a good compliance history.

The U.S. Court of Appeals for the District of Columbia Circuit Tuesday (Jan. 3) affirmed an earlier district court ruling that FDA warning letters, even when supplemented by conversations with agency officials, do not constitute final actions and therefore cannot be the basis of a lawsuit by those receiving the letters.

CMS has decided to delay a controversial wheelchair prepayment demonstration following strong pressure from lawmakers and stakeholders to put off the effort, the agency informed lawmakers Thursday (Dec. 29).

It will be up to the discretion of the Supreme Court whether the biosimilar pathway will be eliminated if the health reform law is declared unconstitutional, according to an industry attorney.