Medicare program; providers and suppliers of specialized services: technical amendments--HCFA. Final rule with comment period

This rule reorganizes Medicare regulations that pertain to providers and suppliers of specialized services, in order to facilitate the incorporation of future rules in logical order. The rule also makes minor technical and editorial changes to clarify the rules and eliminate duplication without substantive change.     

Medicare program; changes to the inpatient hospital prospective payment system and FY 1990 rates; correction and technical amendment--HCFA. Final rule; correction and technical amendment

In the September 1, 1989 issue of the Federal Register (FR Doc. 89-20481), (54 FR 36453), we made revisions to the Medicare inpatient hospital prospective payment system and set forth the prospective payment rates for FY 1990. This notice corrects technical errors made in that document. In addition, we are making a conforming change to section 412.92(a)(2)(iii) to accurately reflect the less burdensome criteria for classification as a sole community hospital. This language conforms to the change we made in section 412.92(a)(3). We intended to change both sections at the same time, but mistakenly left out the changes to section 412.92(a)(2)(iii).     

Medicare program; Medicare coverage of screening mammography; correction--HCFA. Correcting amendment

This document corrects a technical error that appeared in the final regulations published in the Federal Register on September 30, 1994 (59 FR 49826). Those regulations, in part, established conditions for coverage of diagnostic mammography that are similar to those we had established for screening mammography. This correcting amendment restates the applicability of diagnostic mammography to men as well as to women.     

Medicare program; Part B advance payments to suppliers furnishing items or services under Medicare Part B--HCFA. Final rule

This rule establishes requirements and procedures for advance payments to suppliers of Medicare Part B services. An advance payment will be made only if the carrier is unable to process a claim timely; the supplier requests advance payment; we determine that payment of interest is insufficient to compensate the supplier for loss of the use of the funds; and, we expressly approve the advance payment in writing. These rules are necessary to address deficiencies noted by the General Accounting Office in its report analyzing current procedures for making advance payments. The intent of this rule is to ensure more efficient and effective administration of this aspect of the Medicare program.     

Medicare program; requirements for providers and suppliers to establish and maintain Medicare enrollment. Final rule

This final rule requires that all providers and suppliers (other than physicians or practitioners who have elected to "opt-out" of the Medicare program) complete an enrollment form and submit specific information to us. This final rule also requires that all providers and suppliers periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. In addition, this final rule implements provisions in the statute that require us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries.     

Biological technical amendment--FDA. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the biologics regulations to make a minor, technical amendment. The pressure stated at which a sustained sterilization temperature is attained is incorrect. This document corrects that error.     

Medicare program; payment to federally funded health facilities--HCFA. Technical amendments

Final regulations published on October 11, 1989, at 54 FR 41736 redesignated 42 CFR 405.312 as 42 CFR 411.8 and, more specifically. redesignated section 405.312(f) as section 411.8(b)(6). In the redesignation of section 405.312(f) we--1. Unintentionally omitted a word that characterized certain funds and facilities as "Federal"; and 2. Overlooked the need to reflect, in 42 CFR part 410, the rules for Medicare payments to Federally funded health centers. This document corrects those errors by amending sections 410.152 and 411.8.     

Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.     

Medicare program; qualified health maintenance organizations: technical amendments--HCFA. Final rule with comment period

This rule clarifies and updates portions of the HCFA regulations that pertain to Federal qualification and continued regulation of health maintenance organizations (HMOs), inclusion of qualified HMOs in employee health benefits plans, and the administration of outstanding loans and loan guarantees that were awarded before October 1, 1986, under the Public Health Service Act (PHS Act). This rule is part of a special project to clarify and update all of 42 CFR part 417, which contains the regulations applicable to all entities that provide prepaid health care, that is, HMOs, CMPs (competitive medical plans) and HCPPs (health care prepayment plans). These are technical and editorial changes that do not affect the substance of the regulations. They are intended to make it easier to find particular provisions, to provide overviews of the different program aspects, and to better ensure uniform understanding of the rules.     

Medicare program; prior determination for certain items and services. Final rule

This final rule establishes a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This final rule establishes reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained. This rule also responds to public comments on the August 30, 2005 proposed rule.     

Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).     

Medicare program; physician self-referral regulations: change in date for submission of group attestation statement--HCFA. Final rule--technical amendment

This final rule changes (delays) the date by which a group of physicians that wishes to be identified as a group practice for purposes of the physician self-referral regulations (42 CFR 411.350 through 411.361) must file a statement attesting that it meets certain specified conditions.     

Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation.     

Medicare program; Medicare coverage of home health services, Medicare conditions of participation, and home health aide supervision--HCFA. Final rule

This regulation specifies home health aide supervision and duty requirements applicable to all home health agencies (HHAs) and hospices that furnish home health aide services under the Medicare program. It also specifies limitations and exclusions applicable to home health services covered under Medicare. The purpose of this regulation is to clarify Medicare home health policy and to promote consistent administration of the home health benefit.     

Medicare program; swing-bed program changes--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to hospital swing beds that was published on September 7, 1989 (54 FR 37270). The interim rule expanded the swing-bed program to encompass rural hospitals with 50 to 99 beds. It established requirements that approved swing-bed hospitals with more than 49 beds must meet. This rule establishes the interim rules as final regulations with changes. These changes are based on our review and consideration of the public comments.     

Medicare program; Medicare secondary payer data match--HCFA. Notice

This notice provides employers with information about the Medicare Secondary Payer (MSP) Data Match Program that involves HCFA, the Internal Revenue Service, and the Social Security Administration. The Data Match was provided for by Section 6202 of the Omnibus Budget Reconciliation Act of 1989. Under this provision, employers who receive data match questionnaires from HCFA for those employees who are Medicare beneficiaries or the spouse of a Medicare beneficiary must report certain health plan coverage information. The information will be used to determine whether Medicare payments for these beneficiaries should be or should have been primary or secondary to any payment that should be or should have been made by an employer group health plan (GHP).