Medicare program; end-stage renal disease quality incentive program. Final rule

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.     

Medicare program; revisions to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier safeguards. Final rule

This final rule removes the definition of "direct solicitation' and allows DMEPOS suppliers, including DMEPOS competitive bidding program contract suppliers, to contract with licensed agents to provide DMEPOS supplies, unless prohibited by State law. It also removes the requirement for compliance with local zoning laws and modifies certain State licensure requirement exceptions.     

Medicaid program; eligibility changes under the Affordable Care Act of 2010. Final rule, Interim final rule

This final rule implements several provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges ("Exchanges"), and the assurance of coordination between Medicaid, CHIP, and Exchanges. This final rule codifies policy and procedural changes to the Medicaid and CHIP programs related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs.     

Medicare and Medicaid programs; reform of hospital and critical access hospital conditions of participation. Final rule

This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled "Improving Regulation and Regulatory Review.'     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Interim final rule with comment period

This interim final rule with comment period requires hospitals that transfuse blood and blood components to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. These changes are based on recommendations by the Secretary's Advisory Committee on Blood Safety and Availability and are being published in conjunction with the Food and Drug Administration's (FDA) Final Rule, "Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection" ("lookback") found elsewhere in this issue of the Federal Register. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.     

Medicare program; Medicare Integrity Program, fiscal intermediary and carrier functions, and conflict of interest requirements. Final rule

This final rule establishes the Medicare Integrity Program (MIP) and implements program integrity activities that are funded from the Federal Hospital Insurance Trust Fund. This final rule sets forth the definitions related to eligible entities; services to be procured; competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal); procedures for identification, evaluation, and resolution of conflicts of interest; and limitations on contractor liability. This final rule brings certain sections of the Medicare regulations concerning fiscal intermediaries (FIs) and carriers into conformity with the Social Security Act (the Act). The rule distinguishes between those functions that the statute requires to be included in agreements with FIs and those that may be included in the agreements. It also provides that some or all of the functions may be included in carrier contracts.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase III). Final rule

This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self-referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2008. Final rule

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2008. In addition, this final rule revises and rebases the SNF market basket, and modifies the threshold for the adjustment to account for market basket forecast error. This final rule also responds to public comments submitted on the proposed rule and makes a technical correction in the regulations text.     

Medicaid program; citizenship documentation requirements. Final rule

This final rule amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. It also incorporates changes made to these requirements through section 405(c)(1)(A) of Division B of the Tax Relief and Health Care Act (TRHCA), Pub. L. 109-432, enacted December 20, 2006. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's citizenship.     

Exemption of certain systems of records under the Privacy Act. Proposed rule

This proposed rule would exempt the four system of records from subsections (c)(3), (d)(1) through (d)(4),(e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a (k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/Incidents Tracking System ("ACTS"), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System ("HITS"), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System ("OPOS"), HHS/CMS, System No. 09-70-0575; and the Fraud Investigation Database ("FID"), HHS/CMS, System No. 09-70-0527.