The government plans to focus its false claims prosecutions on smaller companies and more nuanced issues, including misleading safety data and economic superiority claims, such as touting a drug's contribution to reduced hospital stays, according to Department of Justice attorneys.

The Advanced Medical Technology Association is repositioning its push for a repeal of the health reform law's device tax as a jobs and economic growth issue in an effort to win over Democrats on Capitol Hill, officials from the group said Tuesday (Feb. 7) as they outlined a broader tax reform plan that includes the device tax repeal.

The insurance industry tells HHS in comments on the health reform law's final medical loss ratio regulation that it appreciates the decision to allow costs associated with the ICD-10 conversation to count as quality improvement activities in 2012 and 2013, but says that costs incurred in 2011 should also be counted and the .3 percent cap should be removed.

House GOP leadership is telling party members not to sign a dear-colleague letter asking conferees to use war savings to pay for fixing the Medicare physician pay formula, delivering a message that lawmakers should avoid boxing in Republican conferees during negotiations, key lobbyists say.

Ten Republican Senate Finance Committee members say they have serious concerns about recent Obama administration marketing efforts designed to highlight various benefits of the health reform law, complaining in a Tuesday (Feb. 7) letter to HHS Secretary Kathleen Sebelius that touting several preventive services through Medicare and private insurance as “free” is highly misleading because individuals will pay for the services in other ways.

In a rare area of agreement between opposing parties in the Supreme Court suit challenging the health reform law, the U.S. government and those challenging the statute agree that the Anti-Injunction Act does not bar a challenge to the Affordable Care Act's individual mandate, according to several briefs filed with the Supreme Court on Monday (Feb. 6).

House Energy and Commerce member Mike Doyle (D-PA) and Senate Finance Committee member Robert Menendez (D-NJ) are urging HHS Secretary Kathleen Sebelius to follow the intent of a health reform law provision they championed by ensuring that behavioral health services related to the treatment of autism are guaranteed as part of the essential health benefits package.

Top Democrats from several House health committees say they intended for the health reform law's essential health benefits package to be a federal decision and tell HHS in a Feb. 6 letter they have serious concerns with the department's plan to both delegate the duty to states and to offer benefit design flexibility for insurers, as outlined in its recent EHB bulletin.

Government attorneys said prosecuting company executives under the Park doctrine will not be a "knee jerk" reaction, with cases likely focusing on individuals who knew what they were doing was wrong, thus preserving it as a valuable legal tool.

A federal advisory panel will debate this week whether to urge HHS to step up efforts to develop a standard method for posting health care worker influenza vaccination rates on a government-run database and may call on the department to impose stiff enough penalties to ensure hospitals comply.

The Internal Revenue Service took steps Friday (Feb. 3) to address industry concerns about potential double taxation for combination products containing a drug and device under health reform-mandated fees by saying that rarely would a product face both the device excise tax and branded prescription drug fee, but also sought more clarity from stakeholders on the issue.

The American Medical Association's decision to add two new primary care seats to its RUC panel has only partially assuaged family physicians' concerns that the influential panel, which helps drive CMS payment rates, is stacked in favor on specialty societies, with a key family physician group telling Inside Health Policy it continues to weigh whether to pull out of the committee.

Two key lawmakers on the Senate health committee are pushing legislation to reform the de novo pathway for medical devices that incorporates elements of other proposals that would remove a requirement to enter and be rejected from the 510(k) pathway before being allowed to file a de novo submission, while also addressing concerns about the time FDA has to review these devices.

A coalition of 31 food groups is heading efforts to keep new food fees out of the administration's forthcoming fiscal 2013 budget, urging HHS Secretary Kathleen Sebelius and the White House Office of Management and Budget in a Jan. 30 letter to focus instead on securing more appropriations for food safety activities.

Difficulties in implementing a new electronic-transaction system for filing Medicare and commercial payer claims are delaying payments to doctors and hospitals to the point that some have begun contacting Congress to complain about the problem, and key physician groups on Thursday (Feb. 2) asked the Obama administration to delay or scrap enforcement of the new system and give advance payments to physicians struggling to meet the Version 5010 mandate.

Several beneficiary advocates are calling on HHS to prohibit states from using grandfathered health plans to set their essential health benefit benchmarks, in particular out of concern for coverage of preventive services and what the selection of a grandfathered plan to serve as an EHB benchmark would mean for Medicaid and Basic Health Plan enrollees' coverage, sources say.

As health care providers push lawmakers to use war savings as a “doc fix” offset, some House Republicans are emphasizing that most of the hospital-pay cuts they proposed in their two-year physician payment patch were included in the president’s Plan for Economic Growth and Deficit Reduction that was released in September.

Sen. Chuck Grassley (R-IA) is asking FDA for details on the extent of and policies surrounding the agency's monitoring of whistleblower activities -- including an alleged interception of emails to the senator's investigator -- sending a letter to the agency in the wake of a lawsuit recently filed by six current and former FDA employees.

FDA informed a bipartisan group of Minnesota lawmakers pushing device reforms that some of their proposals are wrapped into the tentative device user fee deal announced Wednesday, and said the agency would take steps internally to address some of their other concerns, according to sources and a letter FDA sent the lawmakers prior to a Feb. 1 meeting between the lawmakers and agency Commissioner Margaret Hamburg.

A group of House Democrats this week introduced legislation to improve the safety of devices cleared through the 510(k) pathway by preventing recalled devices from being used as predicates, a move that follows recent calls by key lawmakers and safety advocates for increased safety measures for implantable devices as part of legislation reauthorizing user fees.