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: 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: 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; reform of hospital and critical access hospital conditions of participation. Final rule

This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled "Improving Regulation and Regulatory Review.'     

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: changes affecting hospital and critical access hospital conditions of participation: telemedicine credentialing and privileging. Final rule

This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). The final rule will implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. This final rule will remove this undue hardship and financial burden.     

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; 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; hospital conditions of participation: anesthesia services. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule amends the Anesthesia Services Condition of Participation (CoP) for hospitals, the Surgical Services Condition of Participation for Critical Access Hospitals (CAH), and the Ambulatory Surgical Center (ASC) Conditions of Coverage Surgical Services. This final rule changes the physician supervision requirement for certified registered nurse anesthetists furnishing anesthesia services in hospitals, CAHs, and ASCs. Under this final rule, State laws will determine which professionals are permitted to administer anesthetics and the level of supervision required, recognizing a State's traditional domain in establishing professional licensure and scope-of-practice laws. States and hospitals are free to establish additional standards for professional practice and oversight as they deem necessary. The hospital anesthesia services CoP, CAH surgical services CoP, and the conforming change to the anesthesia Conditions of Coverage apply to all Medicare and Medicaid participating hospitals, CAHs, and ASCs.     

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: 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 and Medicaid programs: changes to the hospital and critical access hospital conditions of participation to ensure visitation rights for all patients. Final rule

This final rule will revise the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to provide visitation rights to Medicare and Medicaid patients. Specifically, Medicare- and Medicaid-participating hospitals and CAHs will be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation.     

Medicare and Medicaid programs; conditions for coverage for end-stage renal disease facilities. Final rule

This rule finalizes the February 4, 2005 proposed rule entitled "Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities." It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.     

Medicare and Medicaid programs; condition of participation: immunization standard for long term care facilities. Final rule

The goal of this final rule is to increase immunization rates in Medicare and Medicaid participating long term care (LTC) facilities by requiring LTC facilities to offer each resident immunization against influenza annually, as well as lifetime immunization against pneumococcal disease. LTC facilities will be required to ensure that before offering the immunization, each resident or the resident's legal representative receives education regarding the benefits and potential side effects of immunization. The facilities will be required to offer immunization against influenza annually and immunization against pneumococcal disease once, unless medically contraindicated or the resident or the resident's legal representative refuses immunization. Increasing the use of Medicare-funded preventive services is a goal of both CMS and the Centers for Disease Control and Prevention (CDC). This final rule is intended to increase the number of elderly receiving influenza and pneumococcal immunization and decrease the morbidity and mortality rate from influenza and pneumococcal diseases.     

Medicare and Medicaid programs; hospital conditions of participation: requirements for history and physical examinations; authentication of verbal orders; securing medications; and postanesthesia evaluations. Final rule

In this rule, we finalize changes to four of the current requirements (or conditions of participation (CoPs)) that hospitals must meet to participate in the Medicare and Medicaid programs. Specifically, this final rule revises and updates our CoP requirements for: Completion of the history and physical examination in the medical staff and the medical record services CoPs; authentication of verbal orders in the nursing service and the medical record services CoPs; securing medications in the pharmaceutical services CoP; and completion of the postanesthesia evaluation in the anesthesia services CoP. We also respond to timely public comments submitted on the proposed rule published in the March 25, 2005 Federal Register (70 FR 15266). The changes specified in this final rule are consistent with current medical practice and will reduce the regulatory burden on hospitals.     

Medicare and Medicaid programs: reporting outcome and assessment information set data as part of the conditions of participation for home health agencies. Final rule

This final rule makes revisions in response to public comments received on the January 25, 1999 interim final rule with comment period (64 FR 3748). The interim final rule requires electronic reporting of data from the Outcome and Assessment Information Set as a Condition of Participation for home health agencies.     

Medicare and Medicaid programs; hospital standard for potentially HIV infectious blood and blood products--HCFA. Final rule

This final rule requires hospitals participating in the Medicare and Medicaid programs to take appropriate action when the hospitals learn that they have received whole blood, blood components (including recovered plasma), source plasma, and source leukocytes (hereafter referred to as blood or blood products) that are at increased risk of transmitting Human Immunodeficiency Virus (HIV) infection. If the hospital learns that it has received blood or blood products collected from a donor recently exposed to HIV, before the donor has a sufficient level of antibody to be detected by the screening test for antibody to HIV, the hospital must quarantine any blood or blood products remaining in inventory pending confirmation testing. If the presence of HIV is confirmed by more specific testing, the hospital must notify patients who received the blood or blood product. This final rule is intended to ensure that proper health and safety steps are taken to minimize further spread of HIV infection. A final rule published elsewhere in this Federal Register by the Food and Drug Administration applies the same requirements to entities furnishing transfusion services that do not participate in the Medicare and Medicaid programs and clarifies the responsibilities of blood establishments to identify and notify the transfusion service that received affected blood and blood products.     

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 and Medicaid programs; hospital conditions of participation; identification of potential organ, tissue, and eye donors and transplant hospitals' provision of transplant-related data--HCFA. Final rule

This final rule addresses only provisions relating to organ donation and transplantation. It imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperative in the retrieval processing, preservation, storage, and distribution of tissue and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration with the OPO with which it has an agreement, that the family of every potential donor is informed of its opinion to donate organs or tissues or not to donate. Under the final rule, hospital must work with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of organs and tissues take place. In addition, transplant hospitals must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide, if requested, such data directly to the Department.