Department of Health and Human Services October 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Functional Indications for Implantable Cardioverter Defibrillators.'' Many implantable cardioverter defibrillators (ICDs) currently have a functional indication. This draft guidance is designed to describe ICD functional indications and the types of devices appropriate for the indication; to provide guidance regarding labeling, advertising, and promotion of ICDs with an approved functional indication and cardiac resynchronization therapy defibrillators (CRT/ICDs) with an approved indication that describes the function of the ICD component; and to discuss when to submit an application for an investigational device exemption (IDE) for a study involving a potential new patient population for an ICD with an approved functional indication.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled ``Medicare Care Management Performance Demonstration (MCMP),'' System No. 09-70-0562. MCMP demonstration tests a payment methodology for physician practices that combines Medicare fee-for-service payments with performance-based payments for improvements in information technology systems, patient education, care management, and quality of care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. Mandated by Section 649 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), the MCMP Demonstration seeks to provide incentives for physicians to adopt and integrate information technology systems into their practices, and to improve quality as defined by key measurable outcomes. The primary purpose of the system is to establish a pay-for- performance three year pilot with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud 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 establish a new system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09- 70-0553. On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173). MMA amends the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandate that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the new Medicare Part D benefit, the Act allows Medicare payment to plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) Sec. 423.401. As a condition of payment, all Part D plans must submit data and information necessary for CMS to carry out payment provisions (Sec. 1860D-15(c)(1)(C) and (d)(2) of the Act, and 42 CFR 423.322). The primary purpose of this system is to collect, maintain, and process information on all Medicare covered and non-covered drug events, including non-Medicare drug events, for Medicare beneficiaries participating in the Part D voluntary prescription drug coverage under the Medicare program. The system will process drug event transactions and other drug events as necessary for CMS to help determine appropriate payment of covered drugs. The DDPS will consist of the transaction validation processing, storing and maintaining the drug event data in a large-scale database, and staging the data into data marts to support beneficiary and plan analysis of incurred payment. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist Quality Improvement Organizations; (3) assist Part D prescription drug plans; (4) support an individual or organization for a research, evaluation or epidemiological project; (5) support constituent requests made to a congressional representative; (6) support litigation involving the agency; and (7) combat fraud 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.

The Food and Drug Administration (FDA) is canceling a series of three public meetings entitled ``Vision 2006A Conversation With the American Public.'' These meetings were to be a forum where consumers could interact directly with FDA's leadership to discuss issues of public interest. These meetings were announced in the Federal Register of August 16, 2005 (70 FR 48160).

This interim final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and the State Children's Health Insurance Program (SCHIP), as required under the Improper Payments Information Act (IPIA) of 2002. The IPIA requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and, submit a report on actions the agency is taking to reduce erroneous payments. We published a proposed rule on August 27, 2004 to propose that States measure improper payments in Medicaid and SCHIP and report the State-specific error rates to us for purposes of computing the improper payment estimates for these programs. After extensive analysis of the issues related to having States measure improper payments in Medicaid and SCHIP, including public comments on the provisions in the proposed rule, we are revising our proposed approach. Our new approach incorporates commenters' suggestions to engage a Federal contractor by contracting with that entity to complete the data processing and medical reviews and calculate the State-specific error rates. Based on the States' error rates, the contractor also will calculate the improper payment estimates for these programs which will be reported by the Department of Health and Human Services as required by the IPIA. This interim final rule sets out the types of information that States would need to submit to allow CMS to conduct medical and data processing reviews on claims made in the fee-for-service (FFS) setting. CMS will address estimating improper payments for Medicaid managed care and eligibility and SCHIP FFS, managed care and eligibility at a later time. This rule responds to the public comments on the proposed rule, sets forth the requirements for States to assist us and the contractor to produce State-specific error rates in Medicaid and SCHIP which will be used as the basis for a national error rate, and outlines future plans for measuring eligibility, which may include greater State involvement than the level required for the medical and data processing reviews.

The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments on the June 13 and 14, 2005, public workshop entitled ``Biological Products for Treatment of Rare Plasma Protein Disorders'' (the workshop). We are opening the docket to gather additional information from interested persons on the challenges in the development of products to treat rare plasma protein disorders and on current and future opportunities to facilitate development of such products. Interested persons may also submit comments on the workshop presentations and discussions, which we are also making available.

The House Appropriations Committee Report 108-636 includes a provision for the Health and Human Services Assistant Secretary for Planning and Evaluation (HHS/ASPE) and the Office of Management and Budget (OMB) to establish an interagency committee, to be coordinated by HHS. The committee's role is to examine major federal regulations governing the health care industry and to make suggestions regarding how health care regulation could be coordinated and simplified to reduce costs and burdens and improve translation of biomedical research into medical practice, while continuing to protect patients. This committee will examine the economic impact of the major federal regulations governing the health care industry, and will explore both immediate steps and longer-term proposals for reducing regulatory burden, while maintaining the highest quality health care and other patient protections. In accord with the House Appropriations Committee's intent, ASPE and OMB are undertaking several complementary activities. First, we are establishing an interagency committee to undertake a comprehensive review of federal health care regulations, guidance, and paperwork requirements in order to identify areas for reform. Second, we are planning to hold a series of public meetings in order to hear directly from health care administrators, institutional providers, physicians, practitioners, patients, and others about the impact of regulations, and to identify other potential areas for reform. The public meetings will be held in several cities across the country to provide an opportunity for input. Individuals may also submit written comments, regardless of their ability to attend the public meetings, for consideration by the interagency committee. Information about the schedule of public meetings and registration procedures will be available on the Web site https://aspe.hhs.gov/arrb. In order to assist the committee in studying regulatory impact and reform, in this notice ASPE is also requesting public nominations of federal health care regulations that could be coordinated and simplified to reduce costs and burdens and improve the translation of biomedical research into medical practice. In particular, commenters are requested to suggest specific reforms to regulations, guidance documents, or paperwork requirements that would improve the delivery of health care by increasing efficiency, reducing unnecessary costs, removing uncertainty, and increasing flexibility, while maintaining or improving patient safety and quality of care and other patient protections. The emphasis is on major regulations issued within the last ten (10) years. ASPE requests that commenters, in the selection of which reform ideas to submit, consider the extent to which (1) Benefits (quantitative and/or qualitative) are likely to exceed costs for the reform, (2) benefits (quantitative and/or qualitative) can be increased without exceeding costs, (3) the suggested change would improve patients' health and quality of care, (4) the agency or multiple agencies have statutory authority to make the suggested change, and (5) the rule or program is a major contributor to the regulatory burden imposed on the health care sector. While both legislative and administrative reforms are welcome, administrative reforms such as those that require discretionary rulemaking are more likely to be initiated in a timely manner. The reforms may include modifying, extending, or rescinding regulatory programs, guidance documents or paperwork requirements. Once we receive the nominations from the public, HHS, in cooperation with OMB, will assemble and evaluate the reform nominations and discuss each of them with the relevant HHS Operating Divisions, taking into account statutory, economic, public health, and budgetary considerations.

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated September 2005. The draft guidance provides blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The draft guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The draft guidance contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. When finalized, this draft guidance will replace the October 1988 ``Revised Guideline for the Collection of Platelets, Pheresis.''

In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new system titled, ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities (CPTD) System, System No. 09-70-0560.'' Section 122 of the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Public Law (Pub. L.) 106-554) grants CMS the authority to award at least nine cooperative agreement demonstration projects that will identify methods to reduce disparities in early cancer screening, diagnosis, and treatment for Black, Hispanic, Asian American and Pacific Islander, and American Indian (including Alaskan Native, Eskimo, and Aleut) Medicare beneficiary populations. Demonstration sites will use the best available scientific evidence to identify promising models of cancer screening, diagnosis and treatment interventions to promote health and appropriate utilization of Medicare covered services, eliminate disparities in cancer detection and treatment among ethnic and racial populations of Medicare beneficiaries, and provide information to improve the effectiveness of the Medicare program. The purpose of this system is to collect and maintain demographic and cancer health-related data on Medicare target population beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and Racial Minorities. This system will enable CMS to enroll eligible participants in the demonstration project; randomize participants into intervention and control groups; reimburse demonstration site service claims; and develop, maintain and analyze/evaluate research information showing the potential impact of providing cancer screening, diagnosis and treatment facilitation services to underserved Medicare beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization engaged in the performance activities of the demonstration or in a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud 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 Dates section for comment period.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 25, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Administration on Children, Youth and Families herein announces an urgent grant award to the National Association of Child Care Resource and Referral Agencies (NACCRRA) to provide technical assistance to reestablish the operations of the resource and referral agencies in Mississippi and Louisiana whose operations have been disrupted by Hurricane Katrina. This grant will help to re-establish child care referral services so that families along the Gulf Coast can find child care. This grant will also support local and Statewide inventories of child care need and availability. The amount of the proposed grant to NACCRRA is $99,500 in FY 2005 child care funds. The duration of the grant is 12 months.