Department of Health and Human Services October 22, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Food Safety and Applied Nutrition (CFSAN) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CFSAN's Food Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2010 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2010, the inpatient hospital deductible will be $1,100. The daily coinsurance amounts for CY 2010 will be(a) $275 for the 61st through 90th day of hospitalization in a benefit period; (b) $550 for lifetime reserve days; and (c) $137.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2010. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2010 are $221.00 for aged enrollees and $270.40 for disabled enrollees. The standard monthly Part B premium rate for 2010 is $110.50, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or roughly 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2009 standard premium rate was $96.40.) The Part B deductible for 2010 is $155.00 for all Part B beneficiaries. A beneficiary who has to pay an income-related monthly adjustment may have to pay a total monthly premium of roughly 35, 50, 65 or 80 percent of the total cost of Part B coverage.

We are proposing revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The proposed revisions clarify various program participation requirements; specify changes to strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; and implement new policy such as a Part D formulary policy.