Debra A. McCurdy

Although a May 2014 U.S. District Court ruling vacated HRSA's 340B orphan drug regulation, the agency has issued an interpretive rule affirming its policy on the orphan drug exemption. The pharma industry is up in arms, but what does it all mean?

CMS plans to recompete the supplier contracts awarded in Round 2 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program, with new contracts beginning July 2016.

CMS has just released a proposed rule that would require Medicare prior authorization for certain Medicare Durable Medical Equipment items that the agency characterizes as "frequently subject to unnecessary utilization." The decisions would not be subject to appeal.

Last week, the Centers for Medicare & Medicaid Services published a final rule that reforms federal health policy regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on healthcare providers and suppliers. Here are some highlights.

Late last week, the Health Resources and Services Administration released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. The agency discovered several "recurring critical areas of non-compliance" for healthcare facilities.

The medical directors at the four Durable Medical Equipment Medicare Administrative Contractors have issued a joint open letter to physicians warning about "various marketing schemes" perpetrated by DME suppliers.

The Obama Administration released its proposed federal budget for fiscal year 2015 this week. Virtually all types of healthcare providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed - although that is an unlikely scenario.

Take note, hospitals: the Centers for Medicare & Medicaid Services has recently announced modifications to the implementation of the controversial "2-Midnight" inpatient admissions policy, as well as releasing the preliminary federal disproportionate share hospital allotments for FY2014.

For the second time in two months, Congress has turned to an extension of Medicare sequestration as a funding mechanism -- a troubling new trend for Medicare providers.

The Congressional Budget Office has raised the specter that reform to the Medicare physician fee schedule statutory update formula could increase the likelihood that the ACA's Independent Payment Advisory Board mechanism would be triggered potentially resulting in as much as $0.6 billion in Medicare provider cuts.