Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval--HCFA. Proposed rule

This proposed rule would revise the requirements that hospitals must meet to participate in the Medicare and Medicaid programs. The revised requirements focus on patients care and the outcomes of that care, reflect a cross-functional view of patient treatment, encourage flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are necessary to reflect advances in patient care delivery and quality assessment practices since the requirements were last revised in 1986. They are also an integral part of the Administration's efforts to achieve broad-based improvements in the quality of care furnished through Federal programs and in the measurement of that care, while at the same time reducing procedural burdens on providers. In addition, in an effort to increase the number of organ donations, we are proposing changes in the interaction between hospitals and organ procurement organizations. The proposed rule also would specify that HCFA may terminate the participation agreement of a hospital, skilled nursing facility, home health agency, or other provider if the provider refuses to allow access to its facilities, or examination of its operations or records, by or on behalf of HCFA, as necessary to verify that it is complying with the Medicare law and regulations and the terms of its provider agreement.     

Medicare and Medicaid programs; changes in provider and supplier enrollment, ordering and referring, and documentation requirements; and changes in provider agreements. Final rule

This final rule finalizes several provisions of the Affordable Care Act implemented in the May 5, 2010 interim final rule with comment period. It requires all providers of medical or other items or services and suppliers that qualify for a National Provider Identifier (NPI) to include their NPI on all applications to enroll in the Medicare and Medicaid programs and on all claims for payment submitted under the Medicare and Medicaid programs. In addition, it requires physicians and other professionals who are permitted to order and certify covered items and services for Medicare beneficiaries to be enrolled in Medicare. Finally, it mandates document retention and provision requirements on providers and supplier that order and certify items and services for Medicare beneficiaries.     

Medicare and Medicaid programs; advance directives--HCFA. Final rule

This final rule responds to public comments on the March 6, 1992 interim final rule with comment period that amended the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and managed care plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of the advance directives provisions is to enhance an adult individual's control over medical treatment decisions. This rule confirms the interim final rule with several minor changes based on our review and consideration of public comments.     

Medicare and Medicaid programs: hospice conditions of participation. Final rule

This final rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The final conditions address the comments that we received on the proposed rule published on May 27, 2005. This final rule focuses on the care delivered to patients and their families by hospices and the outcome of that care. The final requirements continue to reflect the unique interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad based improvements in the quality of health care and our efforts to improve the quality of care furnished through the Medicare and Medicaid programs.     

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; hospital conditions of participation: patients' rights. Final rule

This final rule finalizes the Patients' Rights Condition of Participation (CoP) which is applicable to all Medicare- and Medicaid-participating hospitals and contains standards that ensure minimum protections of each patient's physical and emotional health and safety. It responds to comments on the following standards presented in the July 2, 1999 interim final rule: Notice of rights; exercise of rights; privacy and safety; confidentiality of patient records; restraint for acute medical and surgical care; and seclusion and restraints for behavior management. As a result of comments received, we have revised the standards regarding restraint and seclusion and set forth standards regarding staff training and death reporting.     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Final rule

This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals 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. 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 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; electronic health record incentive program--stage 2. Final rule

This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage.     

Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, and May 12, 1997, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to determine whether changes are needed in the qualification requirements for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Medicare and Medicaid programs; revisions to conditions of participation for hospitals--HCFA. Final rule

This final rule establishes as a condition of participation (which facilities must meet in order to participate in the Medicare and Medicaid programs) the requirement that hospitals have a discharge planning process for patients who require such services and specifies the elements of that process. It also changes the required qualifications of a hospital's medical director. These provisions implement sections 9305(c) of the Omnibus Budget Reconciliation Act of 1986 (OBRA '86) and 6025 of the Omnibus Budget Reconciliation Act of 1989. Also, we are not adopting several minor proposed revisions to the conditions for coverage of suppliers of end-stage renal disease (ESRD) services. We are now developing comprehensive revisions to the ESRD regulations and believe that it would be appropriate to reconsider the proposed changes as part of that rulemaking process.     

Medicare and Medicaid programs; nurse aide training and competency evaluation programs--HCFA. Final rule

This rule amends the Medicare and Medicaid regulations pertaining to facilities to incorporate Federal requirements that States have training and competency evaluation by Medicare participating skilled nursing facilities and Medicaid participating nursing facilities and also have a nurse aide registry. The purpose of these provisions is to ensure that nurse aides have the education, practical knowledge, and skills needed to care for residents of facilities participating in the Medicare and Medicaid programs. These requirements implement, in part, sections 4201(a) and 4211(a) of the Omnibus Budget Reconciliation Act of 1987, section 6901(b) of the Omnibus Budget Reconciliation Act of 1989, and sections 4008 and 4801 of the Omnibus Budget Reconciliation Act of 1990.     

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

This final rule revised Medicare and Medicaid regulations concerning surety bond requirements published in the Federal Register (63 FR 29648) on June 1, 1998. Those regulations specified submission compliance dates for all home health agencies (HHAs) to furnish a surety bond to HCFA and/or to the State Medicaid agency. This rule removes those submission compliance dates.     

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

The Balanced Budget Act of 1997 (BBA'97) requires each home health agency (HHA), in order to participate in either the Medicare or the Medicaid program, to secure a surety bond. On January 5, 1998, we published a final rule with comment period that requires that each Medicare-participating HHA 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 rule also requires that an HHA participating in Medicaid must furnish a surety bond in an amount that is the greater of $50,000 or 15 percent of its Medicaid revenues to the Medicaid State agency in each State in which it operates. The rule also requires submittal of the initial bond to HCFA or the State Medicaid agency, or both--as applicable--by February 27, 1998. Because some HHAs have not been able to obtain a surety bond in time to meet the February 27 date, we are removing the date by which HHAs are required to submit the bonds to HCFA and/or the State Medicaid Agency.     

Medicare and Medicaid programs; approved information collection requirements--HCFA. Final rule with comment period

This final rule updates our display of approved control numbers for the collection of information that have been assigned to HCFA by the Office of Management and Budget (OMB). OMB regulations require each agency to include the approval numbers in the agency's rules.     

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.     

Medicaid program; provider qualifications for audiologists. Final rule

This final rule will revise the requirements for audiologists furnishing services under the Medicaid program. As a result, the requirements will create consistency with the Medicare program's definition of a qualified audiologist by recognizing State licensure in determining provider qualifications. These revised standards will expand State flexibility in choosing qualified audiologists.     

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.