Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Medicare program; prior determination for certain items and services. Final rule

This final rule establishes a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This final rule establishes reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained. This rule also responds to public comments on the August 30, 2005 proposed rule.     

Medicare program; adjustment in payment amounts for new technology intraocular lenses furnished by ambulatory surgical centers. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

This final rule establishes a process under which interested parties may request a review of whether the current Medicare payment amount for intraocular lenses furnished by participating ambulatory surgical centers is appropriate for a class of new technology intraocular lenses. This rule implements section 141(b) of the Social Security Act Amendments of 1994, which requires us to develop and implement this process. This rule also serves as the initial notice to those wishing to submit requests for review of the appropriateness of the payment amount with respect to a particular intraocular lens, in accordance with section 416.195 of this rule.     

Medicare and Medicaid programs; religious nonmedical health care institutions and advance directives. Final rule

This final rule implements requirements under the Balanced Budget Act of 1997, which set forth requirements for the new Religious Nonmedical Health Care Institution program and advance directives. This rule finalizes the Medicare requirements for coverage and payment of services furnished by religious nonmedical health care institutions, the conditions of participation that these institutions must meet before they can participate in Medicare, and the methodology we will use to pay these institutions and monitor expenditures for services they furnish. This rule also finalizes the rules governing States' optional coverage of religious nonmedical health care institution services under the Medicaid program. Additionally, this final rule addresses comments we received on the November 30, 1999, interim final rule and also makes minor changes to clarify our policy. Lastly, this rule incorporates a minor change to the requirements for advance directives.     

Autopsies at VA expense. Final rule

The Department of Veterans Affairs (VA) is amending its regulation that governs the performance of autopsies on veterans. This final rule updates outdated cross-references to a statute that previously authorized certain outpatient and ambulatory care, which included post-hospitalization autopsies, and its implementing regulation. This final rule clarifies that consent for an autopsy is implied if a known surviving spouse or next of kin has either not responded to a VA request for permission or has not inquired as to the decedent for 6 months before the decedent's death. This final rule modifies the current regulation to make the laws of the jurisdiction in which the autopsy will be performed the controlling laws for purposes of determining who has authority to grant permission for the autopsy. This final rule also clarifies the authorized purposes of a VA autopsy. Lastly, this final rule clarifies that the authority to order an autopsy includes transporting the body at VA's expense to the place where the autopsy will be performed.     

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; time limitation on recordkeeping requirements under the drug rebate program. Final rule

This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.     

Medicare and Medicaid programs; surety bond requirements for home health agencies--HCFA. Final rule

This final rule revises several provisions of an earlier final rule concerning surety bond requirements published in the Federal Register on January 5, 1998 (63 FR 292). This rule also establishes the surety bond submission compliance data, as described in a notice of intent and in a final rule concerning surety bond requirements published in the Federal Register on March 4, 1998 (63 FR 10730 and 10732). The March 4 documents advised the public that we intended to make technical revisions to the January 5, 1998 final rule and extend the February 27, 1998 compliance date for all home health agencies (HHAs) to furnish a surety bond to HCFA and/or the State Medicaid agency, or both, until 60 days after the date of publication of this final rule. In this rule, for Medicare-participating HHAs, we are establishing a new compliance date to submit a surety bond that is 60 days after the date of publication of this final rule. For Medicaid-participating HHAs, we are establishing a new compliance date to furnish a surety bond that is a date established by the State Medicaid agency up to 120 days after the date of publication of this final rule. We are also responding to comments we received in response to the January 5, 1998 final rule that pertain to the technical revisions we discussed in our March 4, 1998 notice. It is our intention to respond to all comments not addressed herein in a future Federal Register document. This final rule revision does not change the beginning date of the term the initial surety bond is to cover, that is, January 1, 1998.     

Medicare program; home health prospective payment system rate update for calendar year 2012. Final rule

This final rule sets forth updates to the home health prospective payment system (HH PPS) rates, including: the national standardized 60-day episode rates; the national per-visit rates; and the low utilization payment amount (LUPA) under the Medicare PPS for home health agencies effective January 1, 2012. This rule applies a 1.4 percent update factor to the episode rates, which reflects a 1 percent reduction applied to the 2.4 percent market basket update factor, as mandated by the Affordable Care Act. This rule also updates the wage index used under the HH PPS, and further reduces home health payments to account for continued nominal growth in case-mix which is unrelated to changes in patient health status. This rule removes two hypertension codes from the HH PPS case-mix system, thereby requiring recalibration of the case-mix weights. In addition, the rule implements two structural changes designed to decrease incentives to upcode and provide unneeded therapy services. Finally, this rule incorporates additional flexibility regarding face-to-face encounters with providers related to home health care.     

Staring into the abyss: A crisis of the rule of law in the EU

Acceptance of the meaning, operation and enforcement of the rule of law in the EU by its Member States is critical to the Union's legitimacy. Any perceived or real crisis in the rule of law thus merits careful consideration. This article focuses on how a crisis in the rule of law occurred within the EU and how the intended ambiguity of the rule of law has entrenched this crisis. This article argues that the primary cause of the crisis has been the EU's development of a unique ideation of the rule of law ‐ as a constitutional norm, policy instrument and value ‐ that 'hollowed out' the rule of law from a constitutional principle to an expedient policy tool. The EU institutions have entrenched the crisis in the rule of law and then tried to manage the chasm between what it deems as respect for the rule of law and certain Member States' conduct.     

Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies. Final rule

This final rule updates and makes certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. We are also finalizing the interim final rule with comment period published on April 6, 2011, regarding the transition budget-neutrality adjustment under the ESRD PPS,. This final rule also sets forth requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this final rule revises the ambulance fee schedule regulations to conform to statutory changes. This final rule also revises the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime requirement (MLR) that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. Finally, this final rule implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Acquisition Program and responds to comments received on an interim final rule published January 16, 2009, that implemented these provisions of MIPPA effective April 18, 2009. (See the Table of Contents for a listing of the specific issues addressed in this final rule.)     

Medicare program; hospital conditions of participation: requirements for approval and re-approval of transplant centers to perform organ transplants. Final rule

This final rule establishes, for the first time, Medicare conditions of participation for heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers. This rule sets forth clear expectations for safe, high quality transplant service delivery in Medicare-participating facilities. In addition, in this rule we respond to public comments on the proposed rule.     

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 program; establishment of an expedited review process for Medicare beneficiaries enrolled in health maintenance organizations, competitive medical plans, and health care prepayment plans--HCFA. Final rule with comment period

This final rule with comment period establishes a new administrative review requirement for Medicare beneficiaries enrolled in health maintenance organizations (HMOs), competitive medical plans (CMPs), and health care prepayment plans (HCPPs). This rule implements section 1876(c)(5) of the Social Security Act, which specifies the appeal and grievance rights for Medicare enrollees in HMOs and CMPs. This rule requires that an HMO, CMP, or HCPP establish and maintain, as part of the health plan's appeals procedures, an expedited process for making organization determinations and reconsidered determinations when an adverse determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function. This rule also revises the definition of appealable determinations to clarify that it includes a decision to discontinue services.     

Medicare program; hospice wage index for fiscal year 2012. Final rule

This final rule will set forth the hospice wage index for fiscal year (FY) 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This final rule will change the hospice aggregate cap calculation methodology. This final rule will also revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this final rule will begin implementation of a hospice quality reporting program.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE program; nonavailability statement requirements--DoD. Final rule

This final rule revises certain requirements and procedures for the TRICARE Program, the purpose of which is to implement a comprehensive managed health care delivery system composed of military medical treatment facilities and CHAMPUS. Issues addressed in this rule include priority for access to care in military treatment facilities and requirements for payment of enrollment fees. This rule also includes provisions revising the requirement that certain beneficiaries obtain a non-availability statement from a military treatment facility commander prior to receiving certain health care services from civilian providers.     

法治与小康社会

本文以党的十八大报告关于法治与小康社会的基本论述为依据,通过解读十八大报告对小康社会提出的法治建设新要求,即"国家各项工作法治化",创造性地提出了"法治小康"的概念。作者在文章中指出,"法治小康"是对"法治"建设状况与"小康社会"社会发展目标两个方面的期待与要求。作者通过对"法治"价值的基本内涵、"法治化"的最低制度与行为要求,指出了"小康社会"对"法治化"所提出的法治水平最低要求,包括法治"供给"与法治"需求"之间关系的基本适度和平衡;不同法律之间的相互协调,特别是法律制度自身的"统一性";通过贯彻落实依法治国基本方略,来彻底否定人治,弘扬法治,真正地实现"宪法法律至上"的价值目标;通过"法治思维与法治方式"来凝聚成"法治文化"形态的法治精神等等。本文还全面地考察了党的十一届三中全会以来我国"法治"价值内涵的逐渐形成、完善到成熟的发展过程,指出了"依宪治国"、"依宪执政"是实现"小康社会法治化"的必由之路这一重要的法治发展战略目标与机遇。     

Anti-drug program for personnel engaged in specified aviation activities--Federal Aviation Administration. Final rule

On November 14, 1988, the FAA issued a final rule requiring specified aviation employers and operators to submit and implement anti-drug programs for personnel performing sensitive safety- and security-related functions. This final rule modifies that rule by excluding most entities conducting operations that do not require a part 121 or 135 certificate. Entities conducting sightseeing flights in an airplane or rotorcraft for compensation or hire will continue to be covered by the rule.     

Medicare program; uniform electronic cost reporting system for hospitals--HCFA. Final rule

This final rule responds to comments on the May 25, 1994, final rule with comment period that implemented a standardized electronic cost reporting system for all hospitals under the Medicare program. In that rule, we solicited comments on the requirement that cost reporting software be able to detect changes made to the electronic file after the provider has submitted it to the fiscal intermediary. This final rule responds to comments on that requirement and clarifies that although changes to the "as-filed" electronic cost report are prohibited, an intermediary makes a working copy of the as-filed electronic cost report for use in the settlement process.     

Collection from third party payers of reasonable costs of healthcare services--DoD. Final rule

This final rule replaces the current method of per diem billings to one based on diagnostic related groups, expands the single outpatient billing category to as many as sixty, and expands the billing for outpatient services to include land ambulance service, air ambulance service and hyperbaric services. This final rule improves billing methods for both inpatient and outpatient care. This expansion creates a greater level of specificity which more accurately reflects the cost of the care provided. In addition, this final rule identifies additional outpatient services for which recovery of costs will be sought.