Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 inclusion of outpatient hospital facilities--PHS. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992" (the "Act"), enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement (the "Agreement") with the Secretary, Department of Health and Human Services, in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the amount determined under a statutory formula. Section 340B(a)(4) lists the entities eligible to receive discount outpatient drug pricing (i.e., certain disproportionate share hospitals (DSHs) and PHS grantees). The definition of a disproportionate share hospital found in section 340B(a)(4)(L) provides criteria to determine which such hospitals are eligible to participate in the program. However, the definition does not include criteria to determine which outpatient facilities (including off-site or satellite clinics) working in conjunction with the eligible hospital would be considered part of the hospital for purposes of eligibility for section 340B drug discounts. The Office of Drug Pricing, which administers this program with PHS, is proposing certain procedures to determine which outpatient hospital facilities are included as part of an eligible disproportionate share hospital.     

Medicare program; revisions to payment policies and five-year review of and adjustments to the relative value units under the physician fee schedule for calendar year 1997--HCFA. Final rule with comment period

This final rule makes several policy changes affecting Medicare payment for physician services, including payment for diagnostic services and transportation in connection with furnishing diagnostic tests. The final rule also makes changes in geographic payment areas (localities) and changes in the procedure status codes for a variety of services. Since we established the physician fee schedule on January 1, 1992, our experience indicates that some of our policies may need to be reconsidered. This final rule is intended to correct several inequities in physician payment. This final rule also makes changes to work relative value units (RVUs) affecting payment for physician services. Section 1848(c)(2)(B)(i) of the Social Security Act requires that we review all work RVUs no less often than every 5 years. Since we implemented the physician fee schedule effective for services furnished beginning January 1, 1992, we have completed the 5-year review of work RVUs that will be effective for services furnished beginning January 1, 1997. In addition, we are finalizing the 1996 interim RVUs and are issuing interim RVUs for new and revised procedure codes for 1997.     

Medicare program; continuous use of durable medical equipment--HCFA. Interim final rule with comment period

We are setting forth in this interim final rule with comment period the Secretary's determination, required under section 1834(a)(7)(A) of the Social Security Act, of the meaning of the term "continuous" as that term is used in defining a period of continuous use for which we make payments for durable medical equipment.     

Medicare program; continuous use of durable medical equipment--HCFA. Final rule

This final rule responds to public comments on the October 9, 1991 interim final rule with comment period that set forth the Secretary's determination, required under section 1834(a)(7)(A) of the Social Security Act, of the meaning of the term "continuous" as that term is used in defining a period of continuous use for which we make payments for durable medical equipment.     

Medicare program; conditional designation of States in which Medicare SELECT insurance policies may be issued--HCFA. General notice with comment period

This notice announces the Secretary's conditional determination of the 15 States in which Medicare supplemental insurance policies (commonly referred to as "Medigap" policies) may be issued as Medicare SELECT policies. The Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508, amended section 1882 of the Social Security Act to provide for the simplification and standardization of Medicare supplemental insurance policies and to authorize the approval of Medicare SELECT policies in fifteen States, as determined by the Secretary, for a three-year period. Under State-approved Medicare SELECT policies, insurers may restrict full Medicare supplemental insurance benefits to items and services provided by a network of physicians and providers under contract with the insurer. This notice implements section 4358(c) of OBRA '90, which provides for the designation of the 15 States in which Medicare SELECT policies may be approved for issuance during the period January 1, 1992 through December 31, 1994.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase III). Final rule

This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self-referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.     

Medicare program; schedule of limits on home health agency costs per visit for cost reporting periods beginning on or after July 1, 1992--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. This revised schedule of limits applies to cost reporting periods beginning on or after July 1, 1992. As required by section 4207(d)(3)(B) of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), this revised schedule of limits incorporates a blended hospital wage index.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

Under certain circumstances, States are currently permitted to use voluntary contributions (donated funds) from providers and all revenues from State-imposed taxes, as the State share of the costs of the Medicaid program. There is now widespread use of State donations or other voluntary provider payment programs that unfairly affect the Federal share of Federal Financial Participation (FFP). This practice circumvents the States' statutory obligation to expend funds for medical assistance. Therefore, effective January 1, 1992, this interim final rule requires that the amount of funds donated from Medicaid providers be offset from Medicaid expenditures incurred on or after this date before calculating the amount of FFP in Medicaid expenditures. It also interprets section 4701(b)(2) of the Omnibus Budget Reconciliation Act of 1990, which added section 1903(i)(10) to the Social Security Act. Section 1903(i)(10), precludes Federal Financial Participation (FFP) in State payments to hospitals, nursing facilities, and intermediate care facilities for the mentally retarded for facility expenditures that are attributable to provider-specific State taxes.     

Notice regarding HRSA grant requirement--participation in the 340B drug pricing program--HRSA. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on a proposed grant award requirement in which all entities, except those entities which fall within excepted categories, that receive HRSA grants listed in section 340B(a)(4) and that purchase or reimburse for covered outpatient drugs must participate in the 340B Drug Pricing Program, or demonstrate good cause for nonparticipation. When the Prime Vendor program is operational, HRSA intends to publish a second Federal Register notice proposing an expansion of the grant award requirement to include participation in the Prime Vendor Program.     

Medicare program; fee schedules for the services of certified registered nurse anesthetists--HCFA. Final rule

We are revising the Medicare regulations to allow certified registered nurse anesthetists (CRNAs) to receive Medicare payment for the anesthesia services and related care they furnish. In addition, this final rule sets forth the fee schedules under which payment is made for the services of CRNAs, except for the services of CRNAs in certain rural hospitals who are paid on a reasonable cost basis. This rule, which is effective for services furnished on or after January 1, 1989, implements section 9320 of the Omnibus Budget Reconciliation Act of 1986, as amended by section 4084 of the Omnibus Budget Reconciliation Act of 1987, section 411(i)(3) of the Medicare Catastrophic Coverage Act of 1988, section 608(c) of the Family Support Act of 1988, and sections 6106, 6107 and 6132 of the Omnibus Budget Reconciliation Act of 1989. This final rule does not reflect the changes concerning the calculation of payment rates contained in section 1833(1)(4) of the Social Security Act, as enacted by section 4160 of the Omnibus Budget Reconciliation Act of 1990. Those changes apply to services furnished on or after January 1, 1991. Thus, the changes to the payment calculation provisions described and published below are applicable only to services furnished in calendar years 1989 and 1990.     

Final notice regarding section 602 of the Veterans Health Care Act of 1992 duplicate discounts and rebates on drug purchases--HRSA. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides discounts on covered outpatient drugs to eligible entities. Section 340B(a)(5)(A) provides that a drug purchase shall not be subject to both a discount under section 340B and a Medicaid rebate under section 1927 of the Social Security Act. The Department is directed to establish a mechanism to assure that covered entities comply with this prohibition. The purpose of this notice is to announce the final mechanism to prevent duplicate discounts and rebates. The proposed mechanism was announced in the Federal Register at 58 FR 27293 on May 7, 1993. A comment period of 30 days was established to allow public comment on the proposed mechanism. Two comments were received. Both comments concerned issues involving implementation of the mechanism and did not raise substantive issues concerning the mechanism itself; therefore, we will address both comments in the Effective Date section. The mechanism, in its final form, is adopted as proposed.     

Medicare program; criteria and standards for evaluating intermediary and carrier performance during FY 1993--HCFA. General notice with comment period

This notice describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries and carriers in the administration of the Medicare program beginning October 1, 1992. The results of these evaluations are considered whenever HCFA enters into, renews, or terminates an intermediary agreement or carrier contract or takes other contract actions (e.g., assigning or reassigning providers of services to an intermediary, designating regional or national intermediaries, etc.). This notice is published in accordance with sections 1816(f) and 1842(b)(2) of the Social Security Act. We are publishing for public comment in the Federal Register those criteria and standards against which we evaluate intermediaries and carriers.     

Medicaid program; modification of certain requirements for health insuring organizations--HCFA. Final rule

This final rule implements statutory changes which expressly made certain Health Insuring Organizations (HIOs) subject to Medicaid Health Maintenance Organization (HMO) rules. The statute implemented in this rule requires that an HIO which became operational on or after January 1, 1986, and arranges for comprehensive health services for Medicaid recipients on a risk basis be subject to HMO requirements. The statute also provides that exemptions from certain HMO rules are permitted for HIOs which began operation on or after January 1, 1986, if the HIOs are operating under a section 1915(b) waiver obtained prior to that date, or if an HIO is otherwise identified in the law. The exemptions continue as long as the waiver under section 1915(b) of the Social Security Act remains in effect. The statutory provisions implemented in this rule were enacted in section 9517(c) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 9435(e) of the Omnibus Budget Reconciliation Act of 1986, and section 1895(c)(4) of the Tax Reform Act of 1986.     

Medicare and state health care programs: fraud and abuse, civil money penalties and intermediate sanctions for certain violations by health maintenance organizations and competitive medical plans--HHS. Final rule

This final rule implements sections 9312(c)(2), 9312(f), and 9434(b) of Public Law 99-509, section 7 of Public Law 100-93, section 4014 of Public Law 100-203, sections 224 and 411(k)(12) of Public Law 100-360, and section 6411(d)(3) of Public Law 101-239. These provisions broaden the Secretary's authority to impose intermediate sanctions and civil money penalties on health maintenance organizations (HMOs), competitive medical plans, and other prepaid health plans contracting under Medicare or Medicaid that (1) substantially fail to provide an enrolled individual with required medically necessary items and services; (2) engage in certain marketing, enrollment, reporting, or claims payment abuses; or (3) in the case of Medicare risk-contracting plans, employ or contract with, either directly or indirectly, an individual or entity excluded from participation in Medicare. The provisions also condition Federal financial participation in certain State payments on the State's exclusion of certain prohibited entities from participation in HMO contracts and waiver programs. This final rule is intended to significantly enhance the protections for Medicare beneficiaries and Medicaid recipients enrolled in a HMO, competitive medical plan, or other contracting organization under titles XVIII and XIX of the Social Security Act.     

Social Security benefits and supplemental security income; disability termination hearings at the reconsideration level--SSA. Notice of proposed rulemaking

We are proposing regulatory changes to carry out a requirement of Pub. L. 97-455 (enacted on January 12, 1983). That legislation requires several changes in the procedures used by the Social Security Administration (SSA) to conduct periodic reviews of disability cases for continuing eligibility. The proposed regulations would implement Sections 4 and 5 of the new law, which require SSA to make a face-to-face evidentiary hearing available in connection with the reconsideration of any initial determination that an individual receiving disability benefits under title II of the Social Security Act (the Act) is not now disabled. We also propose to make the new reconsideration procedure available in blindness and disability termination cases in the Supplemental Security Income (SSI) program under title XVI of the Act, pursuant to the Secretary's broad rulemaking authority in the SSI program. Although Congress has not specifically required that we do so, it is customary to extend legislative improvements in the title II disability program to comparable SSI cases, since the medical eligibility requirements in both programs are quite similar. Moreover, the proposed inclusion of SSI blindness and disability termination cases would promote effective program administration by providing a uniform appeal procedure in the two programs. We believe that this new procedure will make the reconsideration level more meaningful in blindness and disability termination cases, that beneficiaries affected by these termination decisions will be better served and that the overall quality of the decisionmaking process will also be improved.     

Medicare program: data, standards and methodology used to establish fiscal year 1993 budgets for fiscal intermediaries and carriers--HCFA. Final notice

This notice is published in accordance with sections 1816(c)(1) and 1842(c)(1) of the Social Security Act which requires us to publish the final data, standards and methodology used to establish budgets for Medicare intermediaries and carriers. It announces that we are adopting as final, and responds to comments about, the data, standards, and methodology we proposed to use to establish Medicare fiscal intermediary and carrier budgets for the fiscal year (FY) 1993, beginning October 1, 1992.     

Temporary alien workers seeking H-1B classification under the Immigration and Nationality Act--Immigration and Naturalization Service. Interim rule with requests for comments

This interim rule implements certain provisions of the Miscellaneous and Technical Immigration and Naturalization Amendments of 1991, Public Law 102-232, December 12, 1991, as it relates to aliens seeking nonimmigrant classification and admission to the United States under section 101(a)(15)(H) of the Immigration and Nationality Act (Act). Public Law 102-232 altered, among other things, the procedures for petitioning for H-1B nonimmigrants and established new eligibility criteria for foreign physicians seeking employment in the medical profession in the United States. This rule contains the new procedures required by the legislation and makes Service policy consistent with the intent of Congress. This rule sets forth the new filing procedures and eligibility standards and clarifies for businesses and the general public the requirements for classification and admission.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered surgical procedures for ambulatory surgical centers effective October 1, 1998--HCFA. Proposed rule

In this rule we propose to--Update the criteria for determining which surgical procedures can be appropriately and safely performed in an ambulatory surgical center (ASC); Make additions to and deletions from the current list of Medicare covered ASC procedures based on the revised criteria; Rebase the ASC payment rates using cost, charge, and utilization data collected by a 1994 survey of ASCs; Refine the ratesetting methodology that was implemented by a final notice published on February 8, 1990 in the Federal Register; Require that ASC payment, coverage, and wage index updates be implemented annually on January 1 rather than having these updates occur randomly throughout the year; Reduce regulatory burden; and Make several technical policy changes. This proposed rule implements requirements of section 1833(i)(1) and (2) of the Social Security Act.     

Medicaid program; limitations on aggregate payments to disproportionate share hospitals: federal fiscal year 1995--HCFA. Notice

This notice announces the final Federal fiscal year (FFY) 1995 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 (the Act) and implementing regulations at 42 CFR 447.297 through 447.299. The final FFY 1995 State disproportionate share hospital (DSH) allotments published in this notice supersede the preliminary FFY 1995 DSH allotments that were published in the Federal Register on January 13, 1995 (60 FR 3250).