Medicare and Medicaid programs; announcement of additional application from hospital requesting waiver for organ procurement service area--HCFA. Notice with comment period

This notice announces an additional application that HCFA has received from a hospital requesting waiver from dealing with its designated organ procurement organization (OPO) in accordance with section 1138(a)(2) of the Act. This notice requests comments from OPOs and the general public for our consideration in determining whether such a waiver should be granted.     

Medicare program; schedule of limits on home health agency costs per visit for cost reporting periods beginning on or after October 1, 1997--HCFA. Notice with comment period

This notice sets forth a revised schedule of limits on home health agency costs that may be paid under the Medicare program for cost reporting periods beginning on or after October 1, 1997. These limits replace the per visit limits that were set forth in our July 1, 1996 notice with comment period (61 FR 34344) and supersede those set forth in our July 1, 1997 notice with comment period (61 FR 35608). This notice also provides, in accordance with the Balanced Budget Act of 1997, that there be no changes in the home health per visit limits for cost reporting periods beginning on or after July 1, 1997 and before October 1, 1997 (that is, the cost limits set forth in our July 1, 1996 notice will apply to cost reporting periods beginning during this time period); that the establishment of the cost per visit limitations for cost reporting periods beginning on or after October 1, 1997 be based on 105 percent of the median of the labor-related and nonlabor per visit costs for freestanding home health agencies; that there be no updates in the home health costs limits (including no adjustments for changes in the wage index or other updates) for cost reporting periods beginning on or after July 1, 1994 and before July 1, 1996; and the wage index value that is applied to the labor portion of the per visit limitations be based on the geographic area in which the home health service is furnished.     

Medicare program; schedule of limits on home health agency costs per visit for cost reporting periods beginning on or after July 1, 1997--HCFA. Notice with comment period

This notice sets fort a revised schedule of limits on home health agency costs that may be paid under the Medicare program for cost reporting periods beginning on or after July 1, 1997. These limits replace the per visit limits that were set forth in our July 1, 1996 notice with comment period (61 FR 34344). This notice also responds to comments on the July 1, 1996 notice.     

Medicaid program; home and community-based services waivers for individuals age 65 or older--HCFA. Interim final rule with comment period

This interim final rule amends current Medicaid regulations to permit States to offer, under a Secretarial waiver, a wide array of home and community-based services to individuals age 65 or older who are determined, but for the provision of these services, to be likely to require the level of care furnished in a skilled nursing facility (SNF) or intermediate care facility (ICF) (nursing facility (NF) effective October 1, 1990). The rule allows Federal payment for these and other long term care services, up to an amount specified in section 1915(d)(5)(B) of the Social Security Act, subject to HCFA's approval of the States' requests for waivers and certain assurances made by the States. Once granted, waivers are in effect for 3 years, unless terminated by the State with notice to the Secretary, and are renewable for periods of 5 years. Periodic evaluation, assessment, and review of the care furnished under the waivers is required. This rule implements section 4102 of the Omnibus Budget Reconciliation Act of 1987, as modified by section 411(k) of the Medicare Catastrophic Coverage Act of 1988, section 8432 of the Technical and Miscellaneous Revenue Act of 1988, and section 4741(b) of the Omnibus Budget Reconciliation Act of 1990. This rule is being issued in final and, for the most part, without a delay in the effective date for the reasons explained in section IV, "Waiver of Proposed Rulemaking and Delay in the Effective Date."     

Medical devices; review and revision of compliance policy guides and regulatory requirements for refurbishers, rebuilders, reconditioners, servicers and "as is" remarketers of medical devices; request for comments and information; extension of comment period--FDA. Advance notice of proposed rulemaking; extension of comment period

The Food and Drug Administration (FDA) is extending to June 29, 1998, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of December 23, 1997 (62 FR 67011). This advance notice announced FDA's intention to review and, as needed, to revise compliance policy guides, amend regulatory requirements and, as appropriate, exercise alternative regulatory approaches regarding the remarketing of used medical devices. The agency is taking this action in response to two requests for extensions. This extension of comment period is intended to allow interested persons additional time to submit comments on the ANPRM.     

Medicare program: schedule of prospectively determined payment rates for skilled nursing facility inpatient routine service costs--HCFA. Final notice with comment period

This final notice with comment period sets forth the schedule of payment rates for low Medicare volume skilled nursing facilities for prospective payments for routine service costs for Federal fiscal year 1997 (cost reporting periods beginning on or after October 1, 1996 and before October 1, 1997). Section 1888(d) of the Social Security Act requires the Secretary to establish and publish the prospectively determined payment rates 90 days prior to the beginning of the affected Federal fiscal year.     

Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation

The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.     

Medicaid program; final limitations on aggregate payments to disproportionate share hospitals: Federal fiscal year 1996--HCFA. Notice

This notice announces the final Federal fiscal year (FFY) 1996 national target and individual State allotments for Medicaid payment adjustments made to hospitals that serve a disproportionate number of Medicaid recipients and low-income patients with special needs. We are publishing this notice in accordance with the provisions of section 1923(f)(1)(C) of the Social Security Act and implementing regulations at 42 CFR 447.297 through 447.299. The final FFY 1996 State DSH allotments published in this notice supersede the preliminary FFY 1996 DSH allotments that were published in the Federal Register on May 9, 1996.     

Medicaid program: final limitations on aggregate payments to disproportionate share hospitals: federal fiscal year 1997--HCFA. Notice

This notice announces the final Federal fiscal year (FFY) 1997 national target and individual State allotments for Medicaid payment adjustments made to hospitals that serve a disproportionate number of Medicaid recipients and low-income patients with special needs. We are publishing this notice in accordance with the provisions of section 1923 (f)(1)(C) of the Social Security Act and implementing regulations at 42 CFR 447.297 through 447.299. The final FFY 1997 State disproportionate share hospital (DSH) allotments published in this notice supersede the preliminary FFY 1997 DSH allotments that were published in the Federal Register on January 31, 1997.     

Regulations implementing the Federal Coal Mine Health and Safety Act of 1969, as amended. Employment Standards Administration, Labor. Final rule

On January 22, 1997, the Department issued a proposed rule to amend the regulations implementing the Black Lung Benefits Act. 62 FR 3338-3435 (Jan. 22, 1997). When the comment period closed on August 21, 1997, the Department had received written submissions from almost 200 interested persons, including coal miners, coal mine operators, insurers, physicians, and attorneys. The Department also held hearings in Charleston, West Virginia, and Washington, D.C. at which over 50 people testified. The Department carefully reviewed the testimony and the comments and, on October 8, 1999, issued a second notice of proposed rulemaking. 64 FR 54966-55072 (Oct. 8, 1999). In its second notice, the Department proposed changing several of the most important provisions in its initial proposal. The Department also explained its decision not to alter the original proposal with respect to other key regulations based on the comments received to date. Finally, the Department prepared an initial regulatory flexibility analysis. In order to ensure that small businesses that could be affected by the Department's proposal received appropriate notice of the Department's proposed changes, the Department mailed a copy of the second notice of proposed rulemaking to all coal mine operators contained in the databases maintained by the Mine Safety and Health Administration. The Department initially allowed interested parties until December 7, 1999 to file comments to its second proposal, but extended that period until January 6, 2000. The Department received 37 written submissions before the close of the comment period, from groups representing both coal miners and coal mine operators. The Department also received comments from individual miners, various coal mining and insurance companies, as well as from claims processing organizations, attorneys, and various professional organizations. The Department has carefully reviewed all of the comments, and is issuing its final rule. The rule contains a final regulatory flexibility analysis as required by the Regulatory Flexibility Act.     

Medicare program; physician fee schedule update for calendar year 1996 and physician volume performance standard rates of increase for federal fiscal year 1996--HCFA. Final notice

This final notice announces the calendar year 1996 updates to the Medicare physician fee schedule and the Federal fiscal year 1996 volume performance standard rates of increase for expenditures for physicians' services under the Medicare Supplementary Medical Insurance (Part B) program as required by sections 1848 (d) and (f), respectively, of the Social Security Act. The fee schedule update for calendar year 1996 is 3.8 percent for surgical services, -2.3 percent for primary care services, and 0.4 percent for other nonsurgical services. While it does not affect payment for any particular service, there was a 0.8 percent increase in the update for all physicians' services for 1996. The physician volume performance standard rates of increase for Federal fiscal year 1996 are -0.5 percent for surgical services, 9.3 percent for primary care services, 0.6 percent for other nonsurgical services, and a weighted average of 1.8 percent for all physicians' services. In our July 26, 1995 proposed rule concerning revisions to payment policies under the Medicare physician fee schedule for calendar year 1996, we proposed using category-specific volume and intensity growth allowances in calculating the default Medicare Volume Performance Standard (MVPS). We received 20 comments on this proposal. Since this proposal is related to the MVPS and this notice deals with MVPS issues, we are responding to those comments in this notice instead of in the final rule for the fee schedule entitled "Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value Units Under the Physician Fee Schedule for Calendar Year 1996" published elsewhere in this Federal Register issue.     

Medicare program; update of ambulatory surgical center payment rates and additions to and deletions from the current list of covered surgical procedures--HCFA. Notice with comment period

This notice implements section 1833(i)(2)(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center (ASC) services be reviewed and updated annually, and responds to the public comment we received concerning the ambulatory surgical center payment rate update notice with comment period published on July 5, 1990 (55 FR 27690). It also implements section 1833(i)(1) of the Social Security Act, which requires, in part, that the list of covered ambulatory surgical center procedures be reviewed and updated at least every 2 years. This notice announces additions to and deletions from the list of surgical procedures for which facility services are covered when the procedures are performed in an ASC. This notice also announces the assignment of payment groups for each procedure and responds to public comments received in response to the notice proposing additions to and deletions from the list of covered surgical procedures that was published on December 7, 1990.     

Medicare program; revised procedures for paying claims from providers of services--HCFA. Final notice

This final notice announces the implementation of a uniform payment policy and procedures for paying providers of services under Medicare Parts A and B. The revised payment policy allows providers to elect to receive claims payments through either (1) electronic funds transfer; or (2) hard copy checks sent directly by first class mail. The procedures allow intermediaries and carriers to pay providers through direct deposits into providers' bank accounts if the providers (1) are already electronic media claims billers; (2) accept an electronic remittance notice in lieu of a paper remittance notice; and (3) request electronic funds transfer in writing. The procedures are issued in response to requests from both contractors and HCFA regional offices to implement a policy for payment methods that treats all payees uniformly.     

Medicare and Medicaid programs; conditions for coverage for organ procurement organizations (OPOs). Final rule

This rule finalizes the February 4, 2005 proposed rule entitled "Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs)." It establishes new conditions for coverage for organ procurement organizations (OPOs) that include multiple new outcome and process performance measures based on organ donor potential and other related factors in each service area of qualified OPOs. Our goal is to improve OPO performance and increase organ donation. In addition, this final rule re-certifies these 58 OPOs from August 1, 2006 through July 31, 2010 and provides an opportunity for them to sign agreements with the Secretary that will begin on August 1, 2006 and end on January 31, 2011. New agreements are needed so that the Medicare and Medicaid Programs can continue to pay them for their organ procurement activities after July 31, 2006.     

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program. Final rule

This final rule amends Medicare certification and payment requirements for rural health clinics (RHCs) as required by the Balanced Budget Act of 1997 (BBA). It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limits waivers of certain nonphysician practitioner staffing requirements. This final rule imposes payment limits on provider-based RHCs and prohibits "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. The rule also requires RHCs to establish a quality assessment and performance improvement program that goes beyond current regulations. Finally, this final rule addresses public comments received on the February 28, 2002 proposed rule and makes other revisions for clarity and uniformity and to improve program administration.     

Notification procedures for states implementing "alternative mechanisms" in the individual health insurance market--HCFA. Notice

This notice generally describes the statutory provisions under section 111 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that guarantee availability of individual health insurance coverage to certain individuals with prior group coverage. It also provides procedural guidance for States that intend to implement an alternative mechanism under section 111 of HIPAA. Finally, this notice describes the statutory provisions that will apply in a State that does not implement an acceptable alternative mechanism. This notice does not establish new policy or requirements.     

Public health assessments completed. Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). Notice

This notice announces those sites for which ATSDR has completed public health assessments during the period April 1998 through September 1998. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL), and includes sites for which assessments were prepared in response to requests from the public.     

Medicaid program; allocation of enhanced federal matching funds for increased administrative costs resulting from welfare reform--HCFA. Notice with comment period

This notice with comment period announces the methodology used to determine the allocation, among the States and certain Territories, of a $500 million fund to assist them with the additional expenses attributable to eligibility determinations incurred as a result of the provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, which decouples Medicaid eligibility from receipt of cash assistance for families and children. Also, it announces the actual allocation amount for each State and Territory. The special fund is available for matching a State's or Territory's allowable administrative expenditures incurred only during Federal fiscal years 1997 through 2000, and only during the first 12 calendar quarters in which the State's Temporary Assistance to Needy Families program, which replaced the Aid to Families with Dependent Children program, is in effect after August 21, 1996.     

Medicare program; additions to and deletions from the current list of covered surgical procedures for ambulatory surgical centers--HCFA. Final notice with comment period

This final notice with comment period implements section 1833(i)(1) of the Social Security Act, which requires, in part, that the list of covered ambulatory surgical center (ASC) procedures be reviewed and updated at least every 2 years. This notice announces the specific additions to and deletions from the list of surgical procedures for which facility services are covered when the procedures are performed in a Medicare-participating ASC, as well as the assigned payment groups for each addition. The notice also announces a change in our criteria for deleting procedures from the ASC list. This notice also responds to public comments received in response to our proposed notice published December 14, 1993 (58 FR 65357). In that notice, we requested comments on the proposed additions to and deletions from the list of covered surgical procedures for ASCs; the proposed quantitative change in our deletion criteria; the development of alternatives to the proposed quantitative deletion criteria; and the assignment of payment groups for each addition. Finally, this notice solicits public comment on certain additions to and deletions from the ASC list that had not been suggested in our December 1993 proposed notice. It also solicits public comment on the assignment of payment groups for certain new procedure codes.     

Medicare program; establishment of the Medicare Coverage Advisory Committee and request for nominations for members. Notice

This notice announces the establishment of the Medicare Coverage Advisory Committee that will advise the Secretary of Health and Human Services and the Administrator of the Health Care Financing Administration, as requested by the Secretary, whether medical items and services are reasonable and necessary under title XVIII of the Social Security Act. This notice requests nominations for members for the Committee. This notice also announces the signing by the Secretary on November 24, 1998 of the charter establishing the Committee. This charter ends at close of business on November 23, 2000 unless renewed by the Secretary.