Department of Health and Human Services November 2006 – Federal Register Recent Federal Regulation Documents

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system. This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicare-approved ambulatory surgical center (ASC), which are applicable to services furnished on or after January 1, 2007. This final rule with comment period revises the emergency medical screening requirements for critical access hospitals (CAHs). This final rule with comment period supports implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This final rule continues to implement the requirements of the DRA that require that we expand the ``starter set'' of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital inpatient prospective payment system (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. In this rule, we are finalizing additional quality measures for the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.

This document announces a scheduled CHGME PP conference call for Federal fiscal year (FY) 2007. The purpose of this conference call is to discuss new annual reporting requirements as required under Public Law (Pub. L.) 109-307 for children's hospitals participating in the CHGME PP.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Saline, Silicone Gel, and Alternative Breast Implants.'' This version of the guidance document updates preclinical, clinical, and labeling recommendations described in ``Guidance for Saline, Silicone Gel, and Alternative Breast Implants,'' dated January 13, 2004. The update is based on the latest scientific and medical information on breast implants, and clarifies the type and amount of scientific data that should be submitted to allow FDA to evaluate whether these devices are safe and effective.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Virbac AH, Inc. The supplemental ANADA provides revised labeling for oral use of generic ivermectin paste in horses that conforms to the pioneer product label.

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 Alpharma Inc. The supplemental NADA provides for the use of lasalocid Type A medicated articles containing 20 percent lasalocid activity per pound to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

The Food and Drug Administration (FDA) is announcing a public hearing to solicit general views and information from interested persons on issues concerning the electronic submission of product information to the agency. In particular, FDA is seeking these views and information from interested persons on the feasibility and effect of an all-electronic submission environment, as well as issues related to an electronic regulatory information exchange platform. To help solicit such information and views, FDA is seeking responses to specific questions (see section IV of this document).

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the Well-Being of Children Native American Healthy Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. This Notice also provides additional information about ANA's plan for administering the programs.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Inpatient Rehabilitation Facilities (IRF) Patient Assessment Instrument (IRF-PAI),'' System No. 09-70-1518, last published at 66 Federal Register 56681 (November 9, 2001). Information maintained in this system will continue to contain clinical assessment information for all Medicare Part A fee-for-service patients receiving the services of a Medicare approved IRF. This information will be useful in developing core measures that provide meaningful information on patient characteristics and outcomes across post-acute care settings and will be used by CMS to fulfill its responsibility for validating surveys conducted by accrediting agencies. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0521. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will modify existing routine use number 2 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs relating to assessing and improving IRF quality of care. The modified routine use will be renumbered as routine use number 4. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers increasingly more to specific beneficiary or recipient practices that result in unnecessary cost to federally-funded health benefit programs. CMS proposes to broaden the scope of the disclosure requirement for routine use number 5, authorizing disclosure to national accrediting organizations that have been approved by CMS for deeming authority for Medicare requirements for home health services. Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: (1) Provide identifying information for IRFs that have an accreditation status with the requesting accrediting organization that has been granted deeming authority by CMS, (2) submission of a finder file identifying beneficiaries/patients receiving IRF services, (3) safeguard the confidentiality of the data and prevent unauthorized access, and (4) upon completion of a signed data exchange agreement or a CMS data use agreement. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to support the IRF prospective payment system (PPS) for payment of the IRF Medicare Part A fee-for-services furnished by the IRF to Medicare beneficiaries. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, for evaluating and monitoring the quality of IRF health care and contribute to the accuracy of health insurance operations; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support the functions of Quality Improvement Organizations; (5) assist other insurers; (6) support the functions of national accrediting organizations; (7) support litigation involving the Agency; and (8) combat fraud, waste, and abuse in certain health care programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

In accordance with the requirements of the Privacy Act, we are proposing to modify or alter an existing SOR titled, ``Medicare-Cancer Registry Record System (MCR), System No. 09-70-0042,'' established at 53 FR 38082 (September 29, 1988), and most recently modified at 65 FR 37792 (June 16, 2000). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0509. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separately from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 3 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of information to another Federal or state agency to contribute to the accuracy of CMS' proper payment of Medicare benefits, to enable such agency to administer a Federal health benefits program, and/or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds, to evaluate and to monitor the amount and kinds of services received by Medicare beneficiaries contracting cancer. The added routine use will be numbered as routine use number 2. We will further broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' applies whenever the system collects or maintains PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to link individual- level data from the Surveillance, Epidemiology, and End Results (SEER) tumor registry system, operated by the National Cancer Institute (NCI), with Medicare enrollment and claims data. This linked file will greatly enhance CMS's and NCI's ability to understand and evaluate the amount and kinds of services received by Medicare beneficiaries contracting cancer. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency to conduct activities related to this system; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; and (4) support litigation involving the agency. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

This notice announces the third meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

NICEATM announces the availability of the ``Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): 2004-2005.'' In accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l- 3), this report describes progress made during 2004 and 2005 by ICCVAM and NICEATM. Copies can be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov or by contacting NICEATM at the address given below.