amount. These factors, and the extent to which they each contribute to the variable amount, are as follows:

(i) Approximately 75 percent of the variable amount is based on the number of Medicare beneficiaries living in the State as a percentage of all Medicare beneficiaries nationwide.

(ii) Approximately 10 percent of the variable amount is based on the percentage of the State's total population who are Medicare beneficiaries.

(iii) Approximately 15 percent of the variable amount is based on the percentage of the State's Medicare beneficiaries that reside in rural areas ("rural areas" are defined as all areas not included within a Metropolitan Statistical Area).

(3) Based on the foregoing four factors (that is, the amount of available funds and the three comparative factors), HCFA determines a variable rate for each participating State for each grant period.

(d) Submission of revised budget. A State that receives an amount of grant funds under this subpart that differs from the amount requested in the budget submitted with its application must submit a revised budget to HCFA, along with its acceptance of the grant award, that reflects the amount awarded.

(a) Use of grants. Except as specified in paragraph (b) of this section, a State that receives a grant under this subpart may use the grant for any reasonable expenses incurred in planning, developing, implementing, and/or operating the program for which the grant is made.

(b) Maintenance of effort. A State that receives a grant to supplement an existing program (that is, an existing program enhancement grant)—

(1) Must not use the grant to supplant funds for activities that were conducted immediately preceding the

date of the initial award of a grant made under this subpart and funded through other sources (including inkind contributions).

(2) Must maintain the activities of the program at least at the level that those activities were conducted immediately preceding the initial award of a grant made under this subpart. $403.510 Reporting requirements.

A State that receives a grant under this subpart must submit at least one annual report to HCFA and any additional reports as HCFA may prescribe in the notice of grant award. HCFA advises the State of the requirements concerning the frequency, timing, and contents of reports in the notice of grant award that it sends to the State.

§ 403.512 Administration.

(a) General. Administration of grants will be in accordance with the provisions of this subpart, 45 CFR part 92 ("Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments"), 45 CFR 74.4, the terms of the solicitation, and the terms of the notice of grant award. Except for the minimum funding levels established by § 403.504(b)(1), in the event of conflict between a provision of the notice of grant award, any provision of the solicitation, or of any regulation enumerated in 45 CFR 74.4 or in part 92, the terms of the notice of grant award control.

(b) Notice. HCFA provides notice to each applicant regarding HCFA's decision on an application for grant funding under § 403.504.

(c) Appeal. Any applicant for a grant under this subpart has the right to appeal HCFA's determination regarding its application. Appeal procedures are governed by the regulations at 45 CFR part 16 (Procedures of the Departmental Grant Appeals Board).

PART 405-FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

Subpart A-[Reserved]

Subpart B-Medical Services Coverage Decisions That Relate to Health Care Technology

Sec.

405.201 Scope of subpart and definitions. 405.203 FDA categorization of investigational devices.

405.205 Coverage of a non-experimental/investigational (Category B) device. 405.207 Services related to a noncovered device.

405.209 Payment for a non-experimental/investigational (Category B) device.

405.211 Procedures for Medicare contractors in making coverage decisions for a nonexperimental/investigational (Category

B) device.

405.213 Re-evaluation of a device categorization.

405.215 Confidential commercial and trade secret information.

Subpart C-Suspension of Payment, Recovery of Overpayments, and Repayment of Scholarships and Loans

GENERAL PROVISIONS

405.301 Scope of subpart.

LIABILITY FOR PAYMENTS TO PROVIDERS AND SUPPLIERS, AND HANDLING OF INCORRECT PAYMENTS

405.350 Individual's liability for payments

made to providers and other persons for items and services furnished the individual.

405.351 Incorrect payments for which the individual is not liable.

405.352 Adjustment of title XVIII incorrect

payments.

405.353 Certification of amount that will be

adjusted against individual title II or railroad retirement benefits. 405.354 Procedures for adjustment or recovery-title II beneficiary.

405.355 Waiver of adjustment or recovery. 405.356 Principles applied in waiver of adjustment or recovery.

405.357 Notice of right to waiver consideration.

405.358 When waiver of adjustment or recovery may be applied.

405.359 Liability of certifying or disbursing

officer.

405.373 Proceeding for offset or recoupment. 405.374 Opportunity for rebuttal.

405.375 Time limits for, and notification of, administrative determination after receipt of rebuttal statement.

405.376 Suspension and termination of collection action and compromise of claims for overpayment.

405.377 Withholding Medicare payments to recover Medicaid overpayments.

405.378 Interest charges on overpayment and underpayments to providers, suppliers, and other entities.

REPAYMENT OF SCHOLARSHIPS AND LOANS 405.380 Collection of past-due amounts on scholarship and loan programs.

Subpart D-[Reserved]

Subpart E-Criteria for Determining
Reasonable Charges

405.503 Determining customary charges. 405.504 Determining prevailing charges. 405.505 Determination of locality 405.506 Charges higher than customary or prevailing charges or lowest charge levels.

405.507 Illustrations of the application of the criteria for determining reasonable charges.

405.508 Determination of comparable circumstances; limitation.

405.509 Determining the inflation-indexed charge.

405.511 Reasonable charges for medical services, supplies, and equipment. 405.512 Carriers' procedural terminology and coding systems.

405.515 Reimbursement for clinical laboratory services billed by physicians. 405.517 Payment for drugs that are not paid on a cost or prospective payment basis. 405.534 Limitation on payment for screening mammography services.

405.535 Special rules for nonparticipating physicians and suppliers furnishing screening mammography services.

amount in controversy. 405.745 Amount in controversy ascertained after reconsideration.

405.747 Dismissal of request for hearing; amount in controversy less than $100. 405.750 Time period for reopening initial, revised, or reconsidered determinations and decisions or revised decisions of an ALJ or the Departmental Appeals Board (DAB); binding effect of determination and decisions.

405.753 Appeal of a categorization of a device.

Subpart H-Appeals Under the Medicare Part B Program

405.801 Part B appeals-general description. 405.802 Definitions.

405.803 Initial determination.

405.804 Notice of initial determination. 405.805 Parties to the initial determination. 405.806 Effect of initial determination. 405.807 Review of initial determination. 405.808 Parties to the review.

405.809 Opportunity to submit evidence. 405.810 Review determination.

405.811 Notice of review determination. 405.812 Effect of review determination.

405.2137 Condition: Patient long-term program and patient care plan.

405.2138 Condition: Patients' rights and responsibilities.

405.2139 Condition: Medical records.

405.2140 Condition: Physical environment. 405.2150 Condition: Reuse of hemodialyzers and other dialysis supplies. 405.2160 Condition: Affiliation agreement or arrangement.

405.2161 Condition: Director of a renal dialysis facility or renal dialysis center. 405.2162 Condition: Staff of a renal dialysis facility or renal dialysis center.

405.2163 Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center.

405.2164 Conditions for coverage of special

purpose renal dialysis facilities.

405.2170 Condition: Director of a renal transplantation center.

405.2171 Condition: Minimal service requirements for a renal transplantation center. 405.2180 Termination of Medicare coverage.

405.2414 Nurse practitioner and physician assistant services.

405.2415 Services and supplies incident to nurse practitioner and physician assistant services.

405.2416 Visiting nurse services. 405.2417

Visiting nurse services: Determination of shortage of agencies.

FEDERALLY QUALIFIED HEALTH CENTER
SERVICES

405.2430 Basic requirements.

405.2434 Content and terms of the agreement.

405.2436 Termination of agreement. 405.2440 Conditions for reinstatement after termination by HCFA.

405.2442 Notice to the public. 405.2444 Change of ownership. 405.2446 Scope of services.

405.2448 Preventive primary services. 405.2450 Clinical psychologist and clinical social worker services.

405.2452 Services and supplies incident to clinical psychologist and clinical social worker services.

(b) Definitions. As used in this subpart

Class I refers to devices for which the general controls of the Food, Drug, and Cosmetic Act, such as adherence to good manufacturing practice regulations, are sufficient to provide a reasonable assurance of safety and effectiveness.

Class II refers to devices that, in addition to general controls, require special controls, such as performance standards or postmarket surveillance, to provide a reasonable assurance of safety and effectiveness.

Class III refers to devices that cannot be classified into Class I or Class II because insufficient information exists to determine that either special or general controls would provide reasonable assurance of safety and effectiveness. Class III devices require premarket approval.

Contractors refers to carriers, fiscal intermediaries, and other entities that contract with HCFA to review and adjudicate claims for Medicare services. Experimental/investigational (Category A) device refers to an innovative device believed to be in Class III for which "absolute risk" of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type can be safe and effective).

IDE stands for investigational device exemption. An FDA-approved IDE application permits a device, which would otherwise be subject to marketing clearance, to be shipped lawfully for the purpose of conducting a clinical