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21st Century Cures Act Brings Medicare Reimbursement and Policy Changes in 2017

Changes include increased transparency, delayed DMEPOS payment reductions, changed reimbursement for infusion drugs, changed hospital policies and more. On December 13, 2016, President Obama signed into law the 21st...more

President Obama Signs the 21st Century Cures Act Into Law

The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens. On December 13, 2016, President Obama signed into...more

CMS Finalizes Long-awaited Rule Implementing ACA’s Overpayment Reporting Requirements

CMS provides some clarity in Affordable Care Act final rule, but questions remain, complicating compliance efforts. On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final...more

CMS Proposes New Medicare Reporting and Payment System for Laboratories

Proposed rule will create significant, retroactive reporting requirements for private payor payment rates to clinical laboratories. Many clinical laboratories will need to expend significant resources to track, collect...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

10 Strategic Considerations for Tackling Medicare’s Revised National Coverage Determination Process

CMS’s August 2013 notice establishes a new internal review process, signalling increased agency-initiated activity - The Centers for Medicare & Medicaid Services (CMS or the Agency) has initiated an automatic,...more

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