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.     

Medicare program; carrier jurisdiction for claims for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) and other issues involving suppliers, and criteria and standards for evaluating regional DMEPOS carriers--HCFA. Final rule with comment period

This final rule Modifies regulations to provide that claims for durable medical equipment, prosthetics, orthotics and certain other items covered under part B of Medicare be processed by designated carriers. Specifies the jurisdictions each designated carrier will serve. Changes the method by which claims for these items are allocated among the carriers from "point of sale" to "beneficiary residence." Establishes certain minimum standards for suppliers for purposes of submitting the above claims. Incorporates in regulations certain supplier disclosure requirements imposed under section 4164 of the Omnibus Budget Reconciliation Act of 1990, as part of the process for issuing and renewing a supplier's billing number. Describes the criteria and standards to be used beginning October 1, 1993 for evaluating the performance of designated carriers processing claims for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) in the administration of the Medicare program. Section 1842(b)(2) of the Social Security Act requires us to publish criteria and standards against which we evaluate Medicare carriers for public comment in the Federal Register. We expect the above changes to lead to more efficient and economical administration of the Medicare program.     

Medicare program; competitive acquisition for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) and other issues. Final rule

This final rule establishes competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act. These competitive bidding programs, which will be phased in over several years, utilize bids submitted by DMEPOS suppliers to establish applicable payment amounts under Medicare Part B.     

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; durable medical equipment regional carrier service areas and related matters. Final rule

This final rule provides a mechanism for us to expeditiously make changes to the durable medical equipment regional carrier (DMERC) service area boundaries without notice and comment rulemaking. Through this mechanism, we can change the geographical boundaries served by the regional contractors that process durable medical equipment claims through issuance of a Federal Register notice and make other minor changes in the contract administration of the DMERCs. The mechanism provides a method for increasing or decreasing the number of DMERCs, changing the boundaries of DMERCs based on criteria other than the boundaries of the Common Working File sectors, and awarding new contractors to perform statistical analysis or maintain the national supplier clearinghouse. We will publish these changes and their justifications in a Federal Register notice, rather than through notice and comment rulemaking. Although we may change the number and configuration of regional carriers, we are not altering the criteria and factors that we use in awarding contracts. Through this final rule, we are improving the contracting process so that we can swiftly meet the challenges of the changing healthcare industry and address the changing needs of beneficiaries, suppliers, and the Medicare program.     

Medicare program; payment for durable medical equipment and orthotic and prosthetic devices--HCFA. Final rule

This final rule addresses comments received on an interim final rule with comment period published on December 7, 1992. The interim final rule implemented section 4062(b) of the Omnibus Budget Reconciliation Act of 1987. It specified that payment under the Medicare program for durable medical equipment (DME), prosthetics, and orthotics furnished on or after January 1, 1989 is limited to the lower of the actual charge for the equipment or the fee schedule amount established by the carrier. This final rule describes amendments to the methods for computing fee schedules covering the six classes of DME and how they are updated in subsequent years in accordance with sections 13542 through 13546 of the Omnibus Budget Reconciliation Act of 1993.     

Medicare program; continuous use of durable medical equipment--HCFA. Final rule

This final rule responds to public comments on the October 9, 1991 interim final rule with comment period that set forth the Secretary's determination, required under section 1834(a)(7)(A) of the Social Security Act, of the meaning of the term "continuous" as that term is used in defining a period of continuous use for which we make payments for durable medical equipment.     

Medicare program; Medicare Part D claims data. Final rule

This final rule allows the Secretary to collect claims data that are presently being collected for Part D payment purposes for other research, analysis, reporting, and public health functions. The Secretary needs to use these data because other publicly available data are not, in and of themselves, sufficient for the studies and operations that the Secretary needs to undertake as part of the Department of Health and Human Service's obligation to oversee the Medicare program, protect the public's health, and respond to Congressional mandates. These data will also be used to better identify, evaluate and measure the effects of the Medicare Modernization Act of 2003, (MMA).     

Medicare program; aggregation of Medicare claims for administrative appeals--HCFA. Final rule

Medicare beneficiaries and, under certain circumstances, providers, physicians and other entities furnishing health care services may appeal adverse determinations regarding certain claims for benefits payable under part A and part B of Medicare. For administrative appeals at the carrier or intermediary hearing level or administrative law judge (ALJ) level and for any subsequent judicial review, the amount remaining in dispute must meet or exceed threshold amounts set by statute. Section 1869(b)(2) of the Social Security Act permits claims to be aggregated to reach the ALJ hearing threshold amounts. This final rule establishes a system of aggregation under which individual appellants have one set of requirements for aggregating claims and two or more appellants have a different set of requirements for aggregating claims.     

Medicare program; contracts with health maintenance organizations (HMOs) and competitive medical plans (CMPs)--HCFA. Final rule with comment period

This rule clarifies and updates portions of the HCFA regulations that pertain to the following: The conditions that an HMO or CMP must meet to qualify for a Medicare contract (Subpart J). The contract requirements (Subpart L). The rules for enrollment, entitlement, and disenrollment of Medicare beneficiaries in a contracting HMO or CMP (Subpart K). How a Medicare contract is affected when there is change of ownership or leasing of facilities of a contracting HMO or CMP (Subpart M). These are technical and editorial changes that do not affect the substance of the regulations. They are intended to make it easier to find particular provisions, to provide overviews of the different program aspects, and to better ensure uniform understanding of the rules.     

Medicare program; elimination of statement of intent procedures for filing Medicare claims. Final rule

This final rule removes the written statement of intent (SOI) procedures, set forth in 42 CFR 424.45, used to extend the time for filing Medicare claims. In the absence of an SOI, providers and suppliers (and, where applicable, beneficiaries) have from 15 to 27 months (depending on the date of service) to file claims with Medicare contractors.     

Medicare program; Essential Access Community Hospitals (EACHs) and Rural Primary Care Hospitals (RPCHs)--HCFA. Final rule

These final rules set forth the requirements for designating certain hospitals as EACHs or RPCHs; the conditions that an RPCH must meet to participate in Medicare; and the rules for Medicare payment for services furnished by EACHs and RPCHs. These rules are necessary to implement sections 6003(g) and 6116 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) and section 4008(d) of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90). The amendments are intended to promote regionalization of rural health services in grant States, improve access to hospital and other health services for rural residents, and enhance the provision of emergency and other transportation services related to health care.     

Medicare program; payment for durable medical equipment and orthotic, and prosthetic devices--HCFA. Interim final rule with comment period

This interim final rule implements section 4062(b) of the Omnibus Budget Reconciliation Act of 1987 which specifies that payment under the Medicare program for durable medical equipment, orthotics, and prosthetics furnished on or after January 1, 1989 is limited to the lower of the actual charge for the equipment or the fee schedule established by the carrier. We are setting forth the methods for computing fee schedules for six classes of these items. We are also describing how the fee schedules are updated in subsequent years.     

Medicaid program; deduction of incurred medical expenses (spenddown)--HCFA. Final rule with comment period

This final rule with comment period permits States flexibility to revise the process by which incurred medical expenses are considered to reduce an individual's or family's income to become Medicaid eligible. This process is commonly referred to as "spenddown." Only States which cover the medically needy, and States which use more restrictive criteria to determine eligibility of the aged, blind, and disabled, than the criteria used to determine eligibility for Supplemental Security Income (SSI) benefits (section 1902(f) States) have a spenddown. These revisions permit States to: Consider as incurred medical expenses projected institutional expenses at the Medicaid reimbursement rate, and deduct those projected expenses from income in determining eligibility; combine the retroactive and prospective medically needy budget periods; either include or exclude medical expenses incurred earlier than the third month before the month of application (States must, however, deduct current payments on old bills not previously deducted in any budget period); and deduct incurred medical expenses from income in the order in which the services were provided, in the order each bill is submitted to the agency, by type of service. All States with medically needy programs using the criteria of the SS program may implement any of the provisions. States using more restrict criteria than the SSI program under section 1902(f) of the Social Security Act may implement all of these provisions except for the option to exclude medical expenses incurred earlier than the third month before the month of application.     

Medicare program; swing-bed program changes--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to hospital swing beds that was published on September 7, 1989 (54 FR 37270). The interim rule expanded the swing-bed program to encompass rural hospitals with 50 to 99 beds. It established requirements that approved swing-bed hospitals with more than 49 beds must meet. This rule establishes the interim rules as final regulations with changes. These changes are based on our review and consideration of the public comments.     

Medicare program; supplementary medical insurance premium surcharge agreements. Final rule

This final rule implements legislation contained in section 1839(e) of the Social Security Act (the Act). That statute authorizes a Medicare premium payment arrangement whereby State and local government agencies can enter into an agreement with the Secretary to make periodic lump sum payments for the Supplementary Medical Insurance (SMI) late enrollment premium surcharge amounts due for a designated group of eligible enrollees. Under this rule, we define and set out the basic rules for the new SMI premium surcharge billing agreement. In order to give States additional time for implementation of the provisions of this final rule, we are delaying the rule's effective date to six months from the date of its publication in the Federal Register.     

Medicare program; date for filing Medicare cost reports--HCFA. Final rule

This final rule extends the time frame providers have to file cost reports from no later than 3 months after the close of the period covered by the report to no later than 5 months after the close of that period. This change is necessary to ensure that providers have an adequate amount of time to file complete and accurate cost reports. We are also defining what HCFA considers to be an "acceptable" cost report submission.