Department of Health and Human Services May 8, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for the proposed rule, published in the Federal Register of October 31, 2006 (71 FR 63278). The proposed rule would reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is taking this action in response to two requests for an extension of the comment period for this rulemaking. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

The Food and Drug Administration (FDA) is reopening to June 8, 2007, the comment period for the notice of availability that appeared in the Federal Register of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a system titled, ``End Stage Renal Disease (ESRD) Program Management and Medical Information System (PMMIS), System No. 09-70-0520,'' and last modified at 67 Fed. Reg. 41244 (June 17, 2002). This system contains records on individuals with ESRD who are entitled to receive Medicare benefits or who are treated by Department of Veteran Affairs (DVA) health care facilities. 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. The modified routine use will remain as routine use number 1. For further clarity, we propose to separate existing routine use number 3 that permit disclosures to ESRD Network Organizations and to Quality Improvement Organizations into separate routine uses. The activities performed by the 2 different type organizations are not so closely related that they should be combined in one routine use. The modified routine use will be republished as routine use number 3 for ESRD Network Organizations and routine use number 4 for Quality Improvement Organizations. 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 propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of priority personal information to complete a transfer out event from a losing ESRD facility and/or a transfer-in event to a gaining ESRD facility to: (1) Contribute to the accuracy of CMS' proper payment of Medicare benefits; and (2) enable such facilities to ensure the proper transfer of health records, and/or as necessary to enable such a facility 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; (3) assist ESRD programs which may require PMMIS information for purposes related to this system. Information will be released to these organizations upon specific request, and only for those organizations if they meet the following requirements: (1) Provide an attestation or other qualifying information that they are providing assistance to qualified ESRD beneficiaries; (2) submit a report of the transfer-in or transfer-out event; (3) safeguard the confidentiality of the data and prevent unauthorized access; and (4) complete a written statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The PMMIS data will provide the ESRD facility with information regarding its enrollees' enrollment status, transplant activities, dialysis activities, and Medicare utilization; facilitate the facility's required utilization reviews and medication management program activities; and assist in quality of care issues as they relate to the beneficiary. The added routine use will be numbered as routine use number 6. 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 maintain information on Medicare ESRD beneficiaries, non-Medicare ESRD patients, Medicare approved ESRD hospitals and dialysis facilities, and Department of Veterans Affairs (DVA) patients. The ESRD/PMMIS is used by CMS and the renal community to perform their duties and responsibilities in monitoring the Medicare status, transplant activities, dialysis activities, and Medicare utilization (inpatient and physician/supplier bills) of ESRD patients and their Medicare providers, as well as in calculating the Medicare covered periods of ESRD. 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, agency of a state government, an agency established by state law, or its fiscal agent; (3) support an ESRD Network Organizations; (4) assist Quality Improvement Organizations (QIO) to implement quality improvement programs; (5) facilitate research on the quality and effectiveness of care provided and payment related projects; (6) permit the release of priority personal information to complete a transfer out event and/or a transfer-in event; (7) support litigation involving the agency; and, (8) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new 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 proposed 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 of 1974, CMS is proposing to modify or alter existing system of records titled ``Complaints Against Health Insurance Issuers and Health Plans (CAHII),'' System No. 09-70-9005, established at 66 FR 9858, (February 12, 2001). 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. 09-70-0516. 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 delete routine use number 2 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 add 2 new routine uses authorizing disclosure to support a CMS contractor, consultant, or a grantee of a CMS- administered grant program, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. The new routine use will be published as routine use number 6. We will add a second new routine use to support another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. This new routine use will be published as routine use number 7. We will 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'' apply when ever the system collects or maintain 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 this system is to collect and maintain information initiated by consumers complaints/reports to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of one or more of the following statutes: Sec. Sec. 2722 and 2761 of the Public Health Service (PHS) Act; the Mental Health Parity Act of 1996 (MHPA); the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA); and, the Women's Health and Cancer Rights Act of 1998 (WHCRA). 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 grantee; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs or to his or her eligibility for, or an entitlement to benefits under the Medicare program; (4) inform a health insurance issuer and/or health plan who has been named in a complaint/inquiry and is believed to be potentially in violation of relevant portions of the PHS; (5) support litigation involving the Agency; and (6) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this new 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Chartering Value Exchanges for Value-driven Health Care.'' The information collection will take the form of narrative responses to semiannual Requests for Proposals for participation in a learning network of model multi-stakeholder community health care collaboratives operated to measure, report, and improve the quality and cost of available healthcare. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.