Department of Health and Human Services March 21, 2005 – Federal Register Recent Federal Regulation Documents

This final rule modifies or clarifies our interpretations in several areas of the final rule titled ``Medicare Prescription Drug Benefit'' published in the Federal Register on January 28, 2005. First, it clarifies our interpretation of ``entity'', to respond to inquiries we received subsequent to the publication of the Prescription Drug Benefit (Part D) final rule on January 28, 2005. We were asked whether a joint enterprise could be considered an ``entity'' under section 1860D-12(a)(1) of the Social Security Act (the Act), for purposes of offering a prescription drug plan (PDP). Our interpretation is discussed in the Supplementary Information section of this final rule. Second, also subsequent to the publication of the Prescription Drug Benefit (Part D) final rule on January 28, 2005, we received inquiries from parties about our discussion of the actuarial equivalence standard and the manner in which an employee health plan sponsor could apply the aggregate net value test in the regulatory text of the final rule. Our interpretation is discussed in the ``Provisions'' section of this final rule. In addition, subsequent to publishing the August 3, 2004 proposed rule (69 FR 46684), we received comments on how the late enrollment penalty would be coordinated with the late enrollment penalty for Part B, and whether the one percent penalty would be sufficient to control for adverse selection. We clarify in the Provisions section of this final rule that the example given in the proposed rule, published on August 3, 2004, did not accord with the proposed or final regulatory language because it did not account for the fact that the base beneficiary premium increases on an annual basis. To remedy this error and in response to comments received on the proposed rule, we provide an interpretation that as the base beneficiary premium increases, the late enrollment penalty must also increase, and is in keeping with how the Part B penalty is calculated. Finally, we are providing clarifying language related to transitioning Part D enrollees from their prior drug coverage to their new Part D plan coverage. The Medicare Prescription Drug Benefit final rule will take effect on March 22, 2005. Our interpretations are deemed to be included in that final rule.

The Centers for Disease Control and Prevention announces a new consolidated consumer response service for health information inquiries called the CDC-INFO Contact Center and is phasing out of numerous existing hotlines and clearinghouses serving those purposes.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of a report entitled, ``The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Expert Panel Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants.'' The NICEATM invites public comment on the expert panel report. Copies of the expert panel report may be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address given below.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM are requesting the submission of data that would assist in evaluating the validation status of non- animal methods and approaches used for determining the skin and eye irritation potential of antimicrobial cleaning product formulations to meet regulatory hazard classification and labeling purposes. Additionally, NICEATM is also requesting the nomination of scientists for consideration as potential members of an independent scientific expert panel (``Panel'') to evaluate the proposed methods and approaches. The ICCVAM will consider the conclusions and recommendations from the Panel in developing its recommendations on the validation status of these methods.

The Agency for Healthcare Research and Quality (AHRQ), with the support of the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services and the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education are soliciting the submission of instruments or items that measure the quality of healthcare experienced by people with mobility impairment. The instruments or items will be considered for inclusion in a CAHPS[reg] survey of people with mobility impairment (PWMI). Items or survey instruments may be submitted from researchers, health plans, other health care providers, disability organizations, stakeholders, vendors and other interested parties. This initiative is in response to suggestions from a significant number of stakeholders to develop a CAHPS[reg] tool that measures the quality of care as perceived by adults with disabilities, and to provide performance data to health plans and others that are actionable for quality improvement and access. Our response to stakeholder requests will ultimately provide users with a flexible survey tool to assess the quality of healthcare services for adults with disabilities across multiple settings. The focus of this initial project will be only on people with mobility impairments, and subsequent survey projects may focus on other aspects of disability. Many questions in the existing CAHPS instruments address concerns of people with mobility impairments, including access, communication, courtesy and respect, and shared decision-making. We are particularly interested in identifying and considering new content areas, new response categories and scales for existing questions, and revised wording or question order to make existing questions disability- appropriate.