Medicare program; prospective payment system for long-term care hospitals RY 2009: annual payment rate updates, policy changes, and clarifications; and electronic submission of cost reports: revision to effective date of cost reporting period. Final rule

This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). We are also consolidating the annual July 1 update for payment rates and the October 1 update for Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) weights to a single rulemaking cycle that coincides with the Federal fiscal year (FFY). In addition, we are clarifying various policy issues. This final rule also finalizes the provisions from the Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period interim final rule with comment period that was published in the May 27, 2005 Federal Register which revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This final rule does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.     

Medicare program; electronic submission of cost reports: revision to effective date of cost reporting period. Interim final rule with comment period

This interim final rule with comment period revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This interim final rule with comment does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.     

Medicare and Medicaid programs; conditions of coverage for organ procurement organizations--HCFA. Interim final rule with comment

This interim final rule with comment sets forth changes to the conditions of coverage for organ procurement organizations (OPOs). It redefines an OPO service area, revises the qualifications for the Board of Directors, specifies the assistance to be provided by an OPO to hospitals in establishing and implementing protocols governing organ procurement activity, requires an OPO to establish criteria for allocating organs, and requires an OPO to ensure that tests are performed on prospective organ donors to prevent the acquisition of organs that are infected with the etiologic agent for Acquired Immune Deficiency Syndrome. These changes are required by the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) and the Transplant Amendments Act of 1990 (Public Law 101-616). We also clarify the distinction between certification and designation and amend the criteria with respect to compliance with performance standards, change of ownership, and termination procedures.     

Medicare program; revision of the deadline for submission of emergency graduate medical education affiliation agreements. Final rule

This final rule responds to comments on and revises the deadline for submission of the 2006 emergency Medicare graduate medical education (GME) affiliation agreements. The deadlines to submit the emergency Medicare GME affiliation agreements for the 2005 through 2006 and 2006 through 2007 academic years are changed from on or before June 30, 2006 and July 1, 2006, respectively, to on or before October 9, 2006.     

Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This document extends the comment period for a proposed rule that generally would revise the hospital conditions of participation under Medicare and Medicaid, published in the Federal Register (62 FR 66726) on December 19, 1997. The comment period is extended 60 days for all provisions except the proposed new requirements relating to interactions between hospitals and organ procurement organizations, which are extended for an additional 14 days.     

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

The Balanced Budget Act of 1997-(BBA '97) requires each home health agency (HHA) to secure a surety bond in order to participate in the Medicare and Medicaid programs. This requirement applies to all participating Medicare and Medicaid HHAs, regardless of the date their participation began. This final rule with comment period requires that each HHA participating in Medicare must obtain from an acceptable authorized Surety a surety bond that is the greater of $50,000 or 15 percent of the annual amount paid to the HHA by the Medicare program, as reflected in the HHA's most recently accepted cost report. The BBA '97 also requires that provider agreements be amended to incorporate the surety bond requirement; this rule deems such agreements to be amended accordingly. The BBA '97 prohibits payment to a State for home health services under Medicaid unless the HHA has furnished the State with a surety bond that meets Medicare requirements. This final rule with comment period requires that, in order to participate in Medicaid, each HHA must obtain from an acceptable authorized Surety, a surety bond that is the greater of $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services for which Federal Financial Participation (FFP) is available. In addition to the surety bond requirement, an HHA entering the Medicare or Medicaid program on or after January 1, 1998 must demonstrate that it actually has available sufficient capital to start and operate the HHA for the first 3 months. Undercapitalized providers represent a threat to the quality of patient care.     

Medicare program; coverage of, and payment for, paramedic intercept ambulance services. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule responds to public comments received on a final rule with comment period published on January 25, 1999 that implemented section 4531(c) of the Balanced Budget Act of 1997 concerning Medicare coverage of, and payment for, paramedic intercept ambulance services in rural communities. It also implements section 412 of the Medicare, Medicaid, and State Children's Health Insurance Programs Balanced Budget Refinement Act of 1999 by adding a new definition of a rural area.     

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).     

Medicare and Medicaid programs; announcement of additional applications from hospitals requesting waivers for organ procurement service area--HCFA

This notice announces two additional applications that HCFA has received from hospitals requesting waivers from entering into agreements with their designated organ procurement organizations (OPOs) in accordance with section 1138(a)(2) of the Social Security Act. It supplements notices published in the Federal Register on January 19, 1996, May 17, 1996, November 8, 1996, April 21, 1997, and September 17, 1997, that announced hospital waiver requests received by us. This notice requests comments from OPOs and the general public for our consideration in determining whether these waivers should be granted.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2001 rates. Health Care Financing Administration (HCFA), HHS. Final rule

We are revising the Medicare hospital inpatient prospective payment system for operating costs to: implement applicable statutory requirements, including a number of provisions of the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (Pub. L. 106-113); and implement changes arising from our continuing experience with the system. In addition, in the Addendum to this final rule, we describe changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes apply to discharges occurring on or after October 1, 2000. We also set forth rate-of-increase limits and make changes to our policy for hospitals and hospital units excluded from the prospective payment systems. We are making changes to the policies governing payments to hospitals for the direct costs of graduate medical education, sole community hospitals and critical access hospitals. We are adding a new condition of participation on organ, tissue, and eye procurement for critical access hospitals that parallels the condition of participation that we previously published for all other Medicare-participating hospitals. Lastly, we are finalizing a January 20, 2000 interim final rule with comment period (65 FR 3136) that sets forth the criteria to be used in calculating the Medicare disproportionate share adjustment in reference to Medicaid expansion waiver patient days under section 1115 of the Social Security Act.     

Medicare and Medicaid programs; revaluation of assets--HCFA. Final rule

This final rule revises the Medicare and Medicaid regulations that are affected by section 2314 of the Deficit Reduction Act of 1984 and sections 9110 and 9509 of the Consolidation Omnibus Budget Reconciliation Act of 1985. Those provisions amended sections 1861(v)(1) and 1902(a)(13) of the Social Security Act. This rule describes new limitations on the valuation of assets acquired as the result of changes in ownership occurring on or after July 18, 1984. These changes affect hospitals and skilled nursing facilities under the Medicare program and hospitals, nursing facilities, and intermediate care facilities for the mentally retarded under the Medicaid program.     

Medicare and Medicaid programs; programs of all-inclusive care for the elderly (PACE). Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This rule establishes requirements for Programs of All-inclusive Care for the Elderly (PACE) under Medicare and Medicaid. These are pre-paid, capitated programs for beneficiaries who meet special eligibility requirements and who elect to enroll. Programs must apply for approval and are evaluated in terms of specific criteria. Only a limited number of programs can be approved. Priority consideration will be given to applicants that have been operating under ongoing PACE demonstration projects.     

Medicare and Medicaid programs; quarterly listing of program issuances and coverage decisions--HCFA. General notice

This notice lists HCFA manual instructions, substantive and interpretive regulations and other Federal Register notices, and statements of policy that were published during July, August, and September of 1992 that relate to the Medicare and Medicaid programs. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe. We also are providing the content of revisions to the Medicare Coverage Issues Manual published between July 1 and September 30, 1992. On August 21, 1989 (54 FR 34555), we published the contents of the Manual and indicated that we will publish quarterly any updates. Adding the Medicare Coverage Issues Manual changes to this listing allows us to fulfill this requirement in a manner that facilitates identification of coverage and other changes in our manuals.     

Medicare and state health care programs: fraud and abuse; safe harbors for protecting health plans--HHS. Interim final rule with request for comment

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this interim final rule establishes two new safe harbors and amends one existing safe harbor to provide protection for certain health care plans, such as health maintenance organizations and preferred provider organizations. The first new provision protects certain incentives to enrollees (including waiver of coinsurance and deductible amounts) paid by health care plans. The second new provision protects certain negotiated price reduction agreements between health care plans and contract health care providers. Finally, an existing safe harbor has been amended to protect certain agreements entered into between hospitals and Medicare SELECT insurers. These safe harbors specifically set forth various standards and guidelines that, if met, will result in the particular arrangement being protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Medicare and Medicaid programs: effective dates of provider agreements and supplier approvals--HCFA. Final rule

This rule establishes uniform criteria for determining the effective dates of Medicare and Medicaid provider agreements and of the approval of Medicare suppliers when the provider or supplier is subject to survey and certification as a basis for determining participation in those programs. It also establishes appeal rights and procedures for entities that are dissatisfied with effective date determinations.     

Medicare and Medicaid programs; quarterly listing of program issuances and coverage decisions--third quarter 1993--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations and other Federal Register notices, and statements of policy that were published during July, August, and September of 1993 that relate to the Medicare and Medicaid programs. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe. No revisions to the Medicare Coverage Issues Manual were published during the third quarter of 1993.     

Medicare program; electronic submission of cost reports. Final rule

This final rule amends regulation by requiring that, for cost reporting periods ending on or after December 31, 2004, all hospices, organ procurement organizations, rural health clinics, Federally qualified health centers, community mental health centers, and end-stage renal disease facilities must submit cost reports currently required under the Medicare regulations in a standardized electronic format. This rule also allows a delay or waiver of this requirement when implementation would result in financial hardship for a provider. The provisions of this rule allow for more accurate preparation and more efficient processing of cost reports.     

Medicare, Medicaid, and Children's Health Insurance Programs; additional screening requirements, application fees, temporary enrollment moratoria, payment suspensions and compliance plans for providers and suppliers. Final rule with comment period

This final rule with comment period will implement provisions of the ACA that establish: Procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in the Children's Health Insurance Program (CHIP); an application fee imposed on institutional providers and suppliers; temporary moratoria that may be imposed if necessary to prevent or combat fraud, waste, and abuse under the Medicare and Medicaid programs, and CHIP; guidance for States regarding termination of providers from Medicaid and CHIP if terminated by Medicare or another Medicaid State plan or CHIP; guidance regarding the termination of providers and suppliers from Medicare if terminated by a Medicaid State agency; and requirements for suspension of payments pending credible allegations of fraud in the Medicare and Medicaid programs. This final rule with comment period also discusses our earlier solicitation of comments regarding provisions of the ACA that require providers of medical or other items or services or suppliers within a particular industry sector or category to establish compliance programs. We have identified specific provisions surrounding our implementation of fingerprinting for certain providers and suppliers for which we may make changes if warranted by the public comments received. We expect to publish our response to those comments, including any possible changes to the rule made as a result of them, as soon as possible following the end of the comment period. Furthermore, we clarify that we are finalizing the adoption of fingerprinting pursuant to the terms and conditions set forth herein.     

Health information technology: standards, implementation specifications, and certification criteria for electronic health record technology, 2014 edition; revisions to the permanent certification program for health information technology. Final rule

With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program's name to the ONC HIT Certification Program.