HHS intends to propose that the health reform law's essential health benefits be defined by a benchmark plan selected by each state, with the benchmark serving as a reference plan reflecting the scope of services and any limits offered by a “typical employer plan” in that state, according to a new pre-regulatory EHB bulletin released Friday (Dec. 16).

Congress' Medicare Payment Advisory Commission on Thursday (Dec. 15) discussed a draft recommendation to cut back reimbursements for hospital evaluation & maintenance services, brushing off a letter it received from a hospital industry trade group two days earlier aimed at derailing the proposal, which House Republicans picked up this week as a main payment offset for their 'doc fix' bill.

A bipartisan group of senators is pushing legislation that would let FDA give conditional clearance to certain devices cleared through the 510(k) process, allowing the agency to require post-market data for devices with potential safety risks as a condition of approval.

FDA Thursday issued an interim final rule clarifying requirements that manufacturers solely producing a drug notify the agency at least six months before discontinuing the product, but Congress' investigative arm said lawmakers should further boost the agency's authority to address drug shortages and a Democratic senator continued her legislative press to allow for a more aggressive FDA response.

An HHS official reaffirmed Thursday (Dec. 15) that increased production capacity for generic sterile injectable drugs will solve the impending drug shortage crisis, telling the Senate health committee that payments to manufacturers are not the problem.

Generic drug manufacturers unveiled Thursday (Dec. 5) a proposal to mitigate drug shortages, outlining to the Senate health committee an Accelerated Recovery Initiative that calls for an independent third-party to gather supply information from supply chain stakeholders.

Sources are expecting the administration to delay the compliance date for a health reform law provision that requires insurers to provide a Summary of Benefits and Coverage form and uniform glossary of terms to consumers to help them better understand insurance coverage options.

A House Energy and Commerce Committee Republican says he plans to introduce by the end of the week legislation aimed at facilitating orphan drug use of FDA's accelerated approval process.

Radiology Benefit Managers are asking congressional leaders to consider subjecting all Medicare outpatient imaging services to review by RBMS, which the industry says could save up to $24 billion and protect patients from unnecessary testing.

The Senate Finance Committee is trying to find alternative offsets to the hospitals payment cuts included in the House GOP bill on the “doc fix” and payroll tax holiday, sources say, putting other providers on edge as the committee is holding its cards close to the vest.

Nursing homes are lobbying the Senate to reject Medicare bad debt payment cuts contained as an offset in the House's two-year Medicare physician payment patch that passed Tuesday (Dec. 13), saying that reducing bad debt payments affects all providers but would particularly harm skilled nursing facilities.

An Obama administration plan to support start-up companies in developing and manufacturing medical countermeasures is part of a bipartisan bill passed out of the Senate health committee Wednesday reauthorizing HHS medical countermeasures programs.

Senate Democrats working to craft their own version of a physician payment patch are facing pressure from a wide-ranging group of stakeholders to reject any proposals that would pay for the patch by cutting back Medicare payments for the cancer care delivery system.

Top physician advocates are privately -- and some publicly -- conceding that a one-year Medicare physician payment patch may be their best bet this year, Inside Health Policy has learned, as the two parties remain deeply divided on offsets with less than three weeks until a 27.4 percent pay cut is slated to kick in.

Bipartisan legislation introduced by Rep. William Cassidy (R-LA), a physician and community clinic founder, would create a new CMS demonstration program allowing Medicare and dually eligible beneficiaries to participate in practices that do not accept insurance but charge a monthly flat fee for all primary care services.

The Biotechnology Industry Organization (BIO) is praising a conference deal announced Monday that reauthorizes the Small Business Innovation Research (SBIR) program that was set to expire Friday (Dec. 16) for six more years, and also allows companies that are majority owned by venture capitalists to compete for the grants.

The FDA drug center's Office of Compliance will focus its efforts in 2012 on implementing the Generic Drug User Agreement, addressing supply chain threats, and working with the Office of Criminal Investigation on counterfeit drugs and cargo thefts, the shop's acting director said.

Sen. Ron Wyden (D-OR) and Rep. Edward Markey (D-MA) are urging CMS Acting Administrator Marilyn Tavenner to prioritize a health reform-mandated demonstration that allows Medicare to pay for home visits by physicians involving a small group of beneficiaries with specific chronic diseases.

A coalition of mobile health technology stakeholders is pushing for a separate division within FDA's device center devoted to regulating mobile health devices and technology, while asking the agency for greater clarity on which activities are within its jurisdiction, and how it plans to regulate electronic medical records, accessories and software.

The Early Retiree Reinsurance Program implemented under the health reform law has allocated more than $4.5 billion of its total $5 billion in funding as of Dec. 9, and therefore will no longer be taking claims past Dec. 31 of this year, two years before the program was slated to end, HHS unveiled in a Federal Register notice Friday (Dec. 9).