Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1119 in order to collection additional information during the 2015 open enrollment periods from the 14 operational SBMs (including Washington, DC) to enhance the agency's understanding of the demographic makeup of the citizens enrolling in the various health plans as well as the affordability of those plans. Existing collections gather information from the grant awardee to ensure the CMS is able to conduct their statutory oversight responsibilities. The revision to the weekly reporting requirement is necessary to obtain more accurate and consistent enrollment data during the upcoming Open Enrollment Period which begins November 15, 2014. The immediate need for this revision is due to the State-Based Marketplaces (SBM) maturing business processes and the requirement for more precise reporting of comparison data between the first and second years of ACA implementation. The changes to the revised format of the Weekly Report have been presented to all participating states. CMS is requesting an emergency modification to the weekly reporting template in order to capture certain demographic data and information on new versus re-enrolled individuals in accordance with uniform definitions so as not to produce misleading results.
Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing
This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.