Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988--HCFA. Final rule; correction

In the January 19, 1993 issue of the Federal Register (FR Doc. 93-1169) (58 FR 5215), we updated the rules concerning requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We have identified an error in the text of the regulations and we are correcting it in this notice.     

CLIA program; categorization of tests and personnel modifications--HCFA. Final rule with comment period

In this rule we are responding to some of the comments on categorization of tests and personnel requirements received in response to rules published on February 28, 1992 and January 19, 1993. (In a future rule, we will be responding to the remaining comments.) We are revising our regulations to: Allow dentists and midlevel practitioners to perform tests in the "physician-performed" microscopy (PPM) subcategory of moderate complexity procedures (we now call the subcategory "provider-performed"); include three additional tests in PPM; and expand provisions relating to general supervisor and high complexity testing personnel.     

Medicaid program; eligibility and coverage requirements--HCFA. Final Rule

This final rule withdraws regulations setting forth a mandatory budgetary method for determining financial eligibility for individuals who are not receiving or deemed to be receiving Federal cash assistance but whose financial eligibility for Medicaid is being determined through the application of financial criteria of the Aid to Families with Dependent Children (AFDC) program. These regulations were previously issued as part of a final rule with comment period originally published on January 19, 1993, and were to be effective October 18, 1994. This final rule also makes conforming technical changes, as a result of this withdrawal, to the remainder of the January 19, 1993, final rule and reaffirms the August 18, 1994, effective date of this remaining part. These changes are being made as a result of consideration of public comments received.     

Medicaid program; Medicaid managed care. Withdrawal of final rule with comment period

This document withdraws all provisions of the final rule with comment period on Medicaid managed care that we published in the Federal Register on January 19, 2001 (66 FR 6228) with an initial effective date of April 19, 2001. This January 19, 2001 final rule, which has never taken effect, would have combined Medicaid managed care regulations in a new part 438, implemented Medicaid managed care requirements of the Balanced Budget Act of 1997 (Pub. L. 105-33), and imposed new requirements on entities currently regulated as "prepaid health plans' (PHPs). The regulations set forth in the final rule being withdrawn have been superseded by regulations promulgated in a subsequent rulemaking initiated on August 20, 2001 (66 FR 43613). In addition, this document addresses comments received in response to an interim final rule with comment period that we published on August 17, 2001 in the Federal Register (66 FR 43090) that further delayed, until August 16, 2002, the effective date of the January 19, 2001 final rule with comment period.     

Medicaid program; eligibility and coverage requirements--HCFA. Notice of delay of effective dates and compliance dates

This notice delays by 6 months the effective dates and compliance dates of the final rule with comment period on Medicaid Eligibility and Coverage Requirements published January 19, 1993 in the Federal Register (58 FR 4908).     

Medicaid program; eligibility and coverage requirements--HCFA. Notice of delay of effective dates and compliance dates

This notice delays by an additional 6 months the effective dates of the final rule with comment period on Medicaid Eligibility and Coverage Requirements published January 19, 1993, in the Federal Register (58 FR 4908). It also extends the compliance dates for this rule in light of the delay in the effective dates.     

Medicaid program; eligibility and coverage requirements--HCFA. Notice of delay of effective dates and compliance dates

This document delays by an additional 6 months the effective dates of the final rule with comment period on Medicaid Eligibility and Coverage Requirements published January 19, 1993, in the Federal Register (58 FR 4908). It also extends the compliance dates for this rule in light of the delay in the effective dates. This delay will give the administration additional time necessary to fully review the policies in these regulations.     

Medicare program; physician financial relationships with, and referrals to, health care entities that furnish clinical laboratory services and financial relationship reporting requirements--HCFA. Final rule with comment period

This final rule with comment period provides that, if a physician or a member of a physician's immediate family has a financial relationship with an entity, the physician may not make referrals to the entity for the furnishing of clinical laboratory services under the Medicare program, except under specified circumstances. It contains revisions to our proposal of March 11, 1992, based on comments submitted by the public. Further, it incorporates the new expansions and exceptions created by the Omnibus Budget Reconciliation Act of 1993 and the amendments in the Social Security Act Amendments of 1994 (SSA '94), that are related to referrals for clinical laboratory services and have a retroactive effective date of January 1, 1992. In addition, we are responding to comments received on the interim final rule with comment period (published on December 3, 1991) that set forth Medicare reporting requirements for the submission by certain health care entities of information about their relationships with physicians. That document implemented the reporting requirements of section 1877(f) of the Social Security Act. This rule revises those requirements to incorporate the amendments to section 1877(f) made by SSA '94, to apply to any further reporting we may require.     

Medicare and Medicaid programs; quarterly listing of program issuances and coverage decisions--first 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 January, February, and March 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. There are no revisions to the Medicare Coverage Issues Manual this quarter. However, two notices were published in the Federal Register during the first quarter of 1993 that announced changes made to the Medicare Coverage Issues Manual before to January 1, 1993.     

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.     

Medicare program; self-implementing coverage and payment provisions: 1993 legislation--HCFA. Final rule with comment period

This rule updates Medicare regulations to conform them to certain self-implementing provisions on coverage of services and payment requirements under the Omnibus Budget Reconciliation Act of 1993 (OBRA 93). OBRA 93 was enacted on August 10, 1993 and several of the cited changes to the statute are already in effect and the others will be shortly. We are also implementing a related provision of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) as necessary for consistency and clarity of the OBRA 93 provisions.     

Medicaid program; time limitation on price recalculations and recordkeeping requirements under the drug rebate program. Final rule with comment period

On September 19, 1995, we published a proposed rule in the Federal Register that introduced requirements for States and manufacturers pertaining to the Medicaid drug rebate program. We received several comments from States and manufacturers regarding recordkeeping requirements and drug price recalculations. This final rule with comment period finalizes separately, in an accelerated timeframe, two specific provisions of the September 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. Furthermore, it announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program.     

Medicare program; schedule of limits on home health agency costs per visit--HCFA. Notice with comment period

This notice with comment period 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 July 1, 1993. These limits replace the per-visit limits that were set forth in our July 8, 1993 notice with comment period (58 FR 36748). This notice also provides, in accordance with the provisions of the Omnibus Budget Reconciliation Act of 1993 (OBRA '93), that there will be no changes in the home health agency (HHA) cost limits for cost reporting periods beginning on or after July 1, 1994, and before July 1, 1996. In addition, this notice responds to public comments on the July 8, 1993 notice with comment period, which originally set forth the HHA cost limits for cost reporting periods beginning on or after July 1, 1993, and on the January 6, 1994 notice with comment period (59 FR 760), which announced the elimination of the hospital based add-on effective for cost reporting periods beginning on or after October 1, 1993.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1994 rates--HCFA. Final rule with comment period

We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes arising from our continuing experience with the system. In addition, in the addendum to this final rule with comment period, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 1993, unless the statute provides otherwise. We are also setting forth rate-of-increase limits for hospitals and hospital units excluded from the prospective payment systems. Finally, we are implementing certain changes in the hospital inpatient prospective payment systems resulting from the enactment of the Omnibus Budget Reconciliation Act of 1993 on August 10, 1993.     

Medicaid program; time limitation on record keeping requirements under the drug rebate program. Interim final rule with comment period

On August 29, 2003, we published a final rule with comment period in the Federal Register that finalized two specific provisions: it established new 3-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and set a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announced the pressing need for codification of fundamental recordkeeping requirements. On September 26, 2003, we issued a correction notice to change the effective date of the August 29, 2003 rule from October 1, 2003 to January 1, 2004. In this interim final rule with comment period, we are removing the 3-year recordkeeping requirements, replacing them with 10-year recordkeeping requirements on a temporary basis, and soliciting comments on the 10-year requirements. Manufacturers must retain records beyond the 10-year period if the records are the subject of an audit or a government investigation of which the manufacturer is aware. These provisions contain a sunset date with respect to the record retention requirements to ensure that we reexamine whether the retention rule remain necessary and effective. This interim final rule with comment period also responds to public comments on the August 29, 2003 final rule with comment period that pertain to the 3-year recordkeeping requirement at Sec. 447.534(h).     

Health maintenance organizations: organizational structure and services--HCFA. Correction notice

This document corrects regulatory citations in the preamble of a notice of proposed rulemaking that we issued in the Federal Register on July 15, 1993 (56 FR 38170). The notice proposed to amend the HCFA regulations governing requirements for health maintenance organizations that are Federally qualified (FQHMOs) to incorporate changes made by the Health Maintenance Organization Amendments of 1988 pertaining to the definition of an FQHMO, requirements for providing physician services as basic health services, and requirements for fiscal soundness and insolvency protection.     

Medicare program; Part A premium for 1993 for the uninsured aged and for certain disabled individuals who have exhausted other entitlement--HCFA. Notice

This notice announces the hospital insurance premium for calendar year 1993 under Medicare's hospital insurance program (Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 1993 for these individuals is $221. Section 1818(d) of the Social Security Act specifies the method to be used to determine this amount.     

Privacy Act of 1974; report of new system--HCFA

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records, Evaluation of the Medicare Competition Demonstrations, HHS/HCFA/ORD No. 09-70-0029. We have provided background information about the proposed system in the "Supplementary Information" section below. HCFA invites public comments by January 23, 1984, with respect to routine uses of the system. Dates: HCFA filed a new system report with the Speaker of the House, the President of the Senate, and the Director, Office of Management and Budget (OMB) on December 16, 1983. The new system of records, including routine uses, will become effective 60 days from December 16, 1983, unless HCFA receives comments which would convince us to make a contrary determination.     

The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U