Medicare program; withdrawal of coverage of certain investigational intraocular lenses.--HCFA. Final notice

This notice announces the withdrawal of Medicare coverage for certain investigational intraocular lenses (IOLs). Medicare coverage of IOLs that have received approval by the Food and Drug Administration (FDA) will continue to be covered by Medicare, as well as certain other IOLs that are awaiting FDA approval.     

Medical devices; exception from general requirements for informed consent. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).     

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter, 1998. Health Care Financing Administration (HCFA), HHS. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September 1998, relating to the Medicare and Medicaid programs. This notice also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. 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 also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.     

Medicare and Medicaid programs; quarterly listing of program issuances--second quarter 1997--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during April, May, and June of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 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 time frame.     

Medicare and Medicaid programs; quarterly listing of program issuances--fourth quarter 1997--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during October, November, and December of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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.     

Medicare and Medicaid programs; quarterly listing of program issuances; fourth quarter 1996--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during October, November, and December of 1996 that relate to the Medicare and Medicaid programs. It also indicates certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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 time frame.     

Medicare and Medicaid programs; quarterly listing of program issuances--second quarter, 1998--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during April, May, and June of 1998 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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.     

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter 1996--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September of 1996 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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 time frame.     

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter 1997--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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 time frame.     

Medicare and Medicaid programs; quarterly listing of program issuances--first quarter 1997--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during January, February, and March of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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 time frame.     

Medicare and Medicaid programs; quarterly listing of program issuances--first quarter, 1998--HCFA. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during January, February, and March of 1998 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. 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.     

Medicare program; removal of the requirements for the cardiac pacemaker registry. Health Care Financing Administration, HHS. Final rule

This final rule eliminates all requirements and references regarding the Cardiac Pacemaker Registry (the Registry) in our regulations. It conforms to the Food and Drug Adminstration's (FDA) recent final rule that required any physician and any provider of services who requests or receives Medicare payment for the implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the Registry. We used the information to administer Medicare payment for these devices. This rule implements an Act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress to eliminate duplicative and unnecessary reporting.     

Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.     

Medical devices; classification/reclassification; restricted devices; analyte specific reagents--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify analyte specific reagents (ASR's) presenting a low risk to public health into class I (general controls), and to exempt these class I devices from the premarket notification (510(k)) requirements. FDA is classifying/reclassifying ASR's used in certain blood banking tests as class II (special controls) because general controls are insufficient to provide a reasonable assurance of safety and effectiveness. Finally, ASR's presenting a high risk are being classified or retained in class III (premarket approval). FDA is also designating all ASR's as restricted devices under the Federal Food, Drug and Cosmetic Act (the act), and establishing restrictions on their sale, distribution and use. The scope of products covered by this final rule includes both pre- 1976 devices, which have not been previously classified, as well as post- 1976 devices, which are statutorily classified into class III. The intent of this final rule is to regulate these pre- and post-1976 devices in a consistent fashion. This rulemaking does not affect requirements for reagents that are subject to licensure under the Public Health Service Act (the PHS Act). This rulemaking also does not affect reagents sold to nonclinical settings, including those reagents sold as components to manufacturers of cleared or approved in vitro diagnostic tests.     

Medicare program; reporting requirements for financial relationships between physicians and health care entities that furnish selected items and services--HCFA. Interim final rule with comment period

This interim final rule sets forth reporting requirements under the Medicare program for the submission by certain health care entities of information about their financial relationships with physicians. It implements section 1877(f) of the Social Security Act, which includes the requirements that entities furnishing Medicare covered clinical laboratory services must provide HCFA with information concerning their ownership arrangements. It also provides notice of HCFA's decision to waive the requirements of section 1877(f) with respect to certain entities that do not furnish clinical laboratory services.     

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.     

Medical devices; classification/reclassification of immunohistochemistry reagents and kits--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify immunohistochemistry reagents and kits (IHC's) into three classes depending on intended use. FDA is classifying/reclassifying into class I (general controls) and exempt from premarket notification requirements IHC's used as adjunctive tests and presenting a low risk to public health. FDA is classifying/reclassifying into class II (special control) IHC's that detect or measure certain target analytes and that provide prognostic or predictive data that is not confirmed by routine histopathologic control specimens. The results of the class II IHC's are reported independently to the clinician, and the performance claims are widely accepted and supported by valid scientific evidence. FDA is classifying/reclassifying into class III (premarket approval) IHC's intended for any other use. The scope of products covered by this final rule includes both pre-1976 devices that have not been previously classified, as well as post-1976 devices that are statutorily classified into class III. The intent of this final rule is to regulate pre-1976 devices and post-1976 devices in a consistent fashion. Therefore, FDA is classifying or reclassifying these products as applicable.     

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.