High risk pools. Interim final rule with comment period. Interim final rule with comment period

This interim final rule with comment period will amend our regulations regarding grants to States for operation of qualified high risk pools to conform to provisions of the Deficit Reduction Act of 2005 and the State High Risk Pool Funding Extension Act of 2006. Those provisions extended funding for seed and operational grants for State High Risk Pools and amended section 2745 of the Public Health Service Act.     

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.     

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; physicians' referrals to health care entities with which they have financial relations (Phase II); continuation of effectiveness and extension of timeline for publication of final rule. Interim final rule; continuation of effectiveness and extension of timeline for publication of final rule

This notice announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.     

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.     

Organ procurement and transplantation network. Final rule

This Final Rule sets forth the Secretary's decision to include intestines within the definition of organs covered by the regulations governing the operations of the Organ Procurement and Transplantation Network. The Secretary under the authority granted by section 301 of the National Organ Transplant Act, as amended, further effects a corresponding change to the definition of human organs covered in the statute with this Final Rule.     

Medicare program; home health prospective payment system rate update for calendar year 2011; changes in certification requirements for home health agencies and hospices. Final rule

This final rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: the national standardized 60-day episode rates, the national per-visit rates, the nonroutine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs effective January 1, 2011. This rule also updates the wage index used under the HH PPS and, in accordance with the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), updates the HH PPS outlier policy. In addition, this rule revises the home health agency (HHA) capitalization requirements. This rule further adds clarifying language to the "skilled services" section. The rule finalizes a 3.79 percent reduction to rates for CY 2011 to account for changes in case-mix, which are unrelated to real changes in patient acuity. Finally, this rule incorporates new legislative requirements regarding face-to-face encounters with providers related to home health and hospice care.     

Medicare program; payment policies under the physician fee schedule and other revisions to Part B for CY 2011. Final rule with comment period

This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It finalizes the calendar year (CY) 2010 interim relative value units (RVUs) and issues interim RVUs for new and revised procedure codes for CY 2011. It also addresses, implements, or discusses certain provisions of both the Affordable Care Act (ACA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, this final rule with comment period discusses payments under the Ambulance Fee Schedule (AFS), the Ambulatory Surgical Center (ASC) payment system, and the Clinical Laboratory Fee Schedule (CLFS), payments to end-stage renal disease (ESRD) facilities, and payments for Part B drugs. Finally, this final rule with comment period also includes a discussion regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for durable medical equipment, prosthetics, orthotics, and supplies (CBP DMEPOS), and provider and supplier enrollment issues associated with air ambulances.