Employment discrimination: procedures for handling complaints--Equal Employment Opportunity Commission. Proposed rule

This proposed rule sets forth procedures for the handling of complaints of employment discrimination which are filed with Federal fund granting agencies under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972 and other provisions of Federal law which prohibit discrimination on grounds of race, color, religion, age, sex or national origin in programs or activities receiving Federal financial assistance. The regulations allow the fund granting agency to refer complaints to the Equal Employment Opportunity Commission (EEOC). For complaints covered both by Title VII of the Civil Rights Act of 1964, as amended, or other statutes within EEOC's jurisdiction and by Title VI of the Civil Rights Act or Title IX, the regulations contemplate that most complaints of individual acts of discrimination will be referred to EEOC for investigation and conciliation, while most complaints of systemic discrimination will be retained by the fund granting agency. Employment discrimination complaints which are not covered by Title VI or Title IX will be transferred to EEOC. This proposed rule is not a "major rule" as defined by Section 1(b) of Executive Order 12291.     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Final rule

This final rule clarifies HCFA's policies concerning provider related donations and health care related taxes. In addition, this final rule revises regulations with regard to disproportionate share hospital spending limitations. This final rule amends an interim final rule that was published in the Federal Register on November 24, 1992. The interim final rule established in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The interim final rule also added provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. The provisions of the interim final rule were required by the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

Medicare and Medicaid programs; programs of all-inclusive care for the elderly (PACE); program revisions. Final rule

This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).     

Medicaid program and State Children's Health Insurance Program (SCHIP) payment error rate measurement. Interim final rule with comment period

This interim final rule with comment period sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to estimate and report to the Congress annually these estimates of improper payments for the programs they oversee, and submit a report on actions the agency is taking to reduce erroneous payments. This interim final rule with comment responds to the public comments on the October 5, 2005 interim final rule and sets forth State requirements for submitting claims and policies to the Federal contractor for purposes of conducting FFS and managed care reviews. This interim final rule also sets forth and invites further comments on the State requirements for conducting eligibility reviews and estimating payment error rates due to errors in eligibility determinations.     

Grants, loans and loan guarantees for construction and modernization of hospitals and medical facilities--PHS. Reinstatement of rule

This rule amends Title 42 of the Code of Federal Regulations by reinstating the provision at Section 53.134 concerning notification of the Department of the transfer of a medical facility assisted under Title VI of the Public Health Service Act (the Hill-Burton Act) or termination of services provided in the facility. The provision was incorrectly deleted in a rule published on August 6, 1979, 44 FR 45946.     

Audit requirements for institutions of higher education and other nonprofit organizations--Department of Commerce. Interim final rule with request for comments

The Department of Commerce is implementing Office of Management and Budget (OMB) guidance provided in Circular A-133, "Audits of Institutions of Higher Education and Other Nonprofit Organizations." As a result of this interim final rule, institutions of higher education and other nonprofit organizations that receive Federal assistance are required to periodically perform audits and submit the audit reports to the Federal government. This interim final rule establishes uniform audit requirements applicable to these organizations and defines the Department's responsibilities for implementing and monitoring these requirements.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. Because of misunderstanding created by certain portions of that rule, we are publishing this interim final rule to withdraw and cancel it and to set forth a clearer interim final rule on donations and taxes.     

The Family and Medical Leave Act of 1993--Wage and Hour Division, Department of Labor. Interim final rule; request for comments

This document contains interim regulations implementing the Family and Medical Leave Act of 1993 called ("FMLA" or "the Act"). The Act is effective on August 5, 1993, six months from the date of its enactment. Where a collective bargaining agreement is in effect on August 5, 1993, the Act is effective when the collective bargaining agreement terminates or February 5, 1994, whichever is earlier. The purpose of these regulations is to set forth the requirements of Title I and Title IV of the Act. Title I applies to covered private employers and public agencies (except for most of the Federal Government, which is governed by Title II). Title IV of the Act primarily concerns the relationship between FMLA and other laws, as well as collective bargaining agreements and other employer plans and programs.     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Interim final rule with comment period

This interim final rule establishes in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The rule also adds provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. This interim final rule implements provisions of the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

Medicaid program; state share of financial participation--HCFA. Withdrawal of interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. On October 31, 1991, we published a clarifying interim final rule with comment (56 FR 56132), which withdrew and cancelled the September 12, 1991, interim final rule. After further consideration, the Secretary has also decided to withdraw the October 31, 1991 interim final rule.     

Toll-free number for reporting adverse events on labeling for human drug products. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to codify the provisions of the proposed rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.     

Revisions to the requirements applicable to blood, blood components, and source plasma; confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, other non-profit, and commercial organizations--Department of Commerce. Interim final rule

This interim final rule implements the revisions to the Office of Management and Budget (OMB) Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations" which was published in the Federal Register on November 29, 1993. The revised Circular was developed by an interagency task force for governmentwide use in a model rule format to facilitate regulatory adoption by executive departments and agencies. In the published revised Circular, OMB specified as "required action" that Federal agencies responsible for awarding and administering grants and other agreements to recipients described therein, shall adopt the language of the Circular unless other provisions are required by Federal statute or exceptions or deviations are approved by OMB. This interim final rule adopts the provisions of the Circular and its language to the maximum extent feasible. However, minor changes were made to update the procedures, clarify the language, and make the language apply specifically to the DoC and its operating units. No changes are intended to deviate from the substance of Circular A-110. The Circular covers both grants and cooperative agreements made by Federal agencies and subawards, unless sections of the Circular specifically exclude subrecipients from coverage. Consistent with guidance provided in the Circular, DoC will apply its provisions to grants and agreements with institutions of higher education, hospitals, other nonprofit, and commercial organizations. The provisions of the interim final rule will also apply to foreign governments, organizations under the jurisdiction of foreign governments, and international organizations when appropriate.     

Medicare program; Medicare coverage of screening mammography--HCFA. Final rule

This final rule revises interim final regulations on Medicare coverage of screening mammography that were published in the Federal Register on December 31, 1990 (55 FR 53510). Those regulations implemented section 4163 of the Omnibus Budget Reconciliation Act of 1990, setting forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to ensure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services. As a result of the implementation of the Mammography Quality Standards Act of 1992 (MQSA) by the Food and Drug Administration (FDA), we are conforming the conditions for coverage to the applicable FDA certification requirements that all Medicare suppliers of services must meet effective October 1, 1994. The revisions in this final rule also respond to certain comments we received on the interim final rule published on December 31, 1990; they provide clarification of certain of its provisions; and they establish conditions for coverage of diagnostic mammography that are similar to those we have established for screening mammography. In addition, this final rule reflects changes resulting from the final rule on the fee schedule for physicians' services, which was published in the Federal Register on December 2, 1993 (58 FR 63626).     

Data breaches. Interim final rule

This document establishes regulations to address data breaches regarding sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). The regulations implement certain provisions of Title IX of the Veterans Benefits, Health Care, and Information Technology Act of 2006, which require promulgation of these regulations as an interim final rule.     

Medicare and state health programs: fraud and abuse; issuance of advisory opinions by the OIG--HHS. Final rule

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule sets forth the specific procedures by which the Department, through the Office of the Inspector General (OIG), in consultation with the Department of Justice (DoJ), will issue advisory opinions to outside parties regarding the interpretation and applicability of certain statutes relating to the Federal and State health care programs. The procedures for submitting a request and obtaining an advisory opinion from the OIG were established through interim final regulations published in the Federal Register on February 19, 1997. In response to public comments received on these interim final regulations, this final rule revises and clarifies various aspects of the earlier rulemaking.