May 25, 2007 – Federal Register Recent Federal Regulation Documents

This document adopts as a final rule, with some changes, interim amendments to title 19 of the Code of Federal Regulations (``CFR'') which were published in the Federal Register on March 7, 2006, as CBP Dec. 06-06 to set forth the conditions and requirements that apply for purposes of submitting requests to U.S. Customs and Border Protection for refunds of any excess customs duties paid with respect to entries of textile or apparel goods entitled to retroactive application of preferential tariff treatment under the Dominican RepublicCentral AmericaUnited States Free Trade Agreement.

This proposed rule would clarify the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations; revising the provisions related to appeals of contract determinations and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. This proposed rule would also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities.

This proposed rule would both codify prior clarifications of our policies associated with the Medicare Prescription Drug Benefit (also known as Medicare Part D) and propose certain clarifications of these policies. These clarifications include the following: Codifying our expectations of Part D sponsors regarding providing adequate access to home infusion pharmacies for infused covered Part D drugs and proposing standards with respect to timeliness of delivery of drugs; codifying our guidance that certain supplies associated with the inhalation of insulin are included in the definition of Part D drug; refining our definition of what may be included in the drug costs Part D sponsors use as the basis for calculating beneficiary cost sharing, reporting drug costs to CMS for the purposes of reinsurance reconciliation and risk sharing, as well submitting bids to CMS; reiterating our previous guidance explaining how we interpret the statutory exclusion from the definition of a Part D drug for any drug when used for the treatment of sexual or erectile dysfunction, unless that drug was used for an FDA-approved purpose other than sexual or erectile dysfunction; and codifying our guidance on plan-to-plan reconciliation and reconciliation to a payer other than the Part D of record. In addition, we are correcting the regulations to ensure that they reflect the appropriate subsidy for partial subsidy individuals subject to a late enrollment penalty. We also propose changes to the retiree drug subsidy regulations, including permitting non-calendar year plans to choose between the current year's or the subsequent year's Part D cost limits in certain circumstances and codifying our previous guidance on aggregating plan options for purposes of meeting the net test for actuarial equivalence.

This notice announces two hospitals' requests for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver for each hospital.