Department of Health and Human Services August 13, 2009 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2010
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.
Rescission of February 4, 2004, Order and Subsequent Amendments Prohibiting the Importation of Birds and Bird Products From Specified Countries
On January 21, 2009, CDC published a notice in the Federal Register (74 FR 3608) announcing its intent to rescind its February 4, 2004 order and subsequent amendments prohibiting the importation of birds and bird products from specified countries based on the threat that imports from such countries increases the risk that highly pathogenic avian influenza (HPAI) may be introduced into the United States. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has implemented and continues to enforce regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. While USDA/APHIS actions are based primarily on protecting the U.S. commercial poultry industry from the introduction of highly pathogenic avian influenza H5N1, these actions have the added benefit of mitigating the risk of human exposure to the virus. Because the
New Animal Drugs for Use in Animal Feeds; Oxytetracycline; Neomycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. The supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects FDA's effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.
Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.
Charging for Investigational Drugs Under an Investigational New Drug Application
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.
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