Department of Health and Human Services August 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of post-inspection responses to inspectional observations that are communicated to a firm through issuance of a form FDA 483, list of inspectional observations.

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2010. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses the results of our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification project, as well as a new Resource Utilization Groups, version 4 case-mix classification model for FY 2011 that will use the updated Minimum Data Set 3.0 resident assessment for case-mix classification. In addition, this final rule discusses the public comments that we have received on these and other issues, including a possible requirement for the quarterly reporting of nursing home staffing data, as well as on applying the quality monitoring mechanism in place for all other SNF PPS facilities to rural swing-bed hospitals. Finally, this final rule revises the regulations to incorporate certain technical corrections.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmaceutical Components at Risk for Melamine Contamination.'' This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding avoid the use of components that are at risk for melamine contamination. As of the date of this announcement, FDA is not aware of any pharmaceutical components that are contaminated with melamine.

This final rule updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010 (for discharges occurring on or after October 1, 2009 and on or before September 30, 2010) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.

This proposed rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates; the national standardized 60-day episode rates, the national per-visit rates, the non-routine medical supply (NRS) conversion factor, and the low utilization payment amount (LUPA) add-on payment amount, under the Medicare prospective payment system for home health agencies effective January 1, 2010. In addition, this rule proposes a change to the HH PPS outlier policy and proposes to require the submission of OASIS data as a condition for payment under the HH PPS. Also, this rule proposes payment safeguards that would improve our enrollment process, improve the quality of care that Medicare beneficiaries receive from HHAs, and reduce the Medicare program's vulnerability to fraud. This rule also proposes clarifying language to the ``skilled services'' section and Condition of Participation (CoP) section of our regulations. This proposed rule also clarifies the coverage of routine medical supplies under the HH PPS. We are also soliciting comments on: Physician/patient interaction associated with the home health plan of care (POC); a Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey; the Outcome and Assessment Information Set (OASIS), Version C, effective January 1, 2010; proposed pay for reporting measures for use in CY 2011; and a number of minor payment-related issues. We are also responding to comments received as a result of our solicitation in the CY 2008 HH PPS final rule with comment period.

This document corrects technical errors in the proposed rule entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010'' which appeared in the July 13, 2009 Federal Register.