FDA has issued a new Final Rule governing the safety reports required for drugs under clinical investigation. Among other changes, FDA seeks to limit the number of adverse reaction reports it receives and increase the usefulness of each report. But what does “evidence to suggest a causal relationship” …
Additional ERRP Reimbursement Information Released
Since releasing its first list of plans that have been approved to participate in the Early Retiree Reinsurance Program (ERRP), HHS has published the following additional information on its website to help sponsors of approved plans understand how to next proceed: New Reimbursement Preparation Features Now …
Colorado Opts Out of CRNA Physician Supervision Requirement, but Not Without a Challenge
Last week, Governor Bill Ritter announced that Colorado will become the 16th state to opt-out of a federal Medicare rule that requires physician supervision of certified registered nurse anesthetists (CRNAs) in hospitals. States have the authority to opt-out of the supervision requirement by notifying CMS in …
Does Health Care Reform Require My Plan to Provide Documents in Multiple Languages?
There are two areas where plans may have to provide participant communications in non-English languages. Claims & Appeals Notices: First, for claims and appeals, plans must provide "culturally and linguistically appropriate" notices that inform enrollees of the internal and external appeals processes. To …
Background Checks and Fingerprints: Additional Procedures for High Risk Providers and Suppliers
The ‘Pay and Chase’ approach historically followed by the Centers for Medicare & Medicaid Services is quickly giving way to a ‘Lockout and Secure’ strategy. Earlier this year, Peter Budetti, CMS’s deputy administrator for program integrity, noted that CMS receives 18,000 applications per month for …
Annual Enrollment Materials and Welfare Notices
You may be preparing materials and notices for an upcoming annual enrollment period. Health care reform and other recent laws have added or changed several notices that are required before the next plan year starts (1/1/2011 for calendar-year plans). The agencies have provided several model notices to assist with …