requested, the carrier must provide a written explanation of the adjustments.

(4) The review and explanation described in paragraph (i)(3) of this section is separate from a supplier's right to appeal the amount and computation of benefits paid on the claim, as provided at part 405, subpart H of this chapter. The carrier's reconciliation of amounts advanced and recouped is not an initial determination as defined at § 405.803 of this chapter, and any written explanation of a reconciliation is not subject to further administrative review.

[61 FR 49275, Sept. 19, 1996]

422.104 Special rules on supplemental benefits for M+C MSA plans.

422.105 Special rules for point of service option.

422.106 Special arrangements with employer

groups.

422.108 Medicare secondary payer (MSP) procedures.

422.109 Effect of national coverage determinations (NCDs).

422.110 Discrimination against beneficiaries

prohibited.

422.111 Disclosure requirements. 422.112 Access to services.

422.114 Access to services under an M+C private fee-for-service plan.

422.118 Confidentiality and accuracy of enrollee records.

422.128 Information on advance directives. 422.132 Protection against liability and loss of benefits.

Subpart D-Quality Assurance

422.152 Quality assessment and performance improvement program.

422.154

External review.

422.156 Compliance deemed on the basis of accreditation.

422.157 Accreditation organizations. 422.158

Procedures for approval of accreditation as a basis for deeming compliance.

Subpart E-Relationships With Providers 422.200

Basis and scope.

422.202 Participation procedures. 422.204 Provider credentialing and provider rights.

422.206 Interference with health care professionals' advice to enrollees prohibited. 422.208 Physician incentive plans: requirements and limitations.

422.210 Disclosure of physician incentive plans

422.212 Limitations on provider indem

nification.

422.214 Special rules for services furnished by noncontract providers.

422.216 Special rules for M+C private feefor-service plans.

422.220 Exclusion of services

under a private contract.

furnished

Subpart F-Payments to Medicare+Choice Organizations

422.249

Terminology

422.250 General provisions.

422.252 Annual capitation rates.

422.254 Calculation and adjustment factors. 422.256 Adjustments to capitation rates and aggregate payments.

422.257

Encounter data.

422.258 Announcement of annual capitation rates and methodology changes.

422.262 Special rules for beneficiaries enrolled in M+C MSA plans.

422.562 General provisions.

422.564 Grievance procedures.

422.566 Organization determinations.

422.568 Standard timeframes and notice requirements for organization determinations.

422.570 Expediting certain organization determinations.

422.572 Timeframes and notice requirements for expedited organization determinations.

422.574 Parties to the organization determination.

422.576 Effect of an organization determination.

422.578 Right to a reconsideration. 422.580

Reconsideration defined.

422.582 Request for a standard reconsideration.

422.584 Expediting certain reconsiderations. 422.586 Opportunity to submit evidence. 422.590 Timeframes and responsibility for reconsiderations.

422.592 Reconsideration by an independent entity.

422.594 Notice of reconsidered determination by the independent entity. 422.596 Effect of a reconsidered determination.

422.600 Right to a hearing.

422.602 Request for an ALJ hearing.

422.608 Departmental Appeals Board (the Board) review.

422.641

Subpart N Medicare Contract

Determinations and Appeals

Contract determinations.

422.644 Notice of contract determination. 422.646 Effect of contract determination. 422.648 Reconsideration: Applicability. 422.650 Request for reconsideration. 422.652 Opportunity to submit evidence. 422.654 Reconsidered determination.

422.656 Notice of reconsidered determination.

422.658 Effect of reconsidered determination.

422.660 Right to a hearing.

422.662 Request for hearing.

422.664 Postponement of effective date of a

contract determination when a request for a hearing with respect to a contract determination is filed timely. 422.666 Designation of hearing officer. 422.668 Disqualification of hearing officer. 422.670 Time and place of hearing. 422.672 Appointment of representatives. 422.674 Authority of representatives. 422.676 Conduct of hearing.

1853-Payments to Medicare+Choice (M+C) organizations.

1854-Premiums.

1855-Organization, licensure, and solvency of M+C organizations. 1856- Standards.

1857-Contract requirements.

1859-Definitions; enrollment restriction for certain M+C plans.

(b) Scope. This part establishes standards and sets forth the requirements, limitations, and procedures for Medicare services furnished, or paid for, by Medicare+Choice organizations through Medicare+Choice plans.

§ 422.2 Definitions.

As used in this part

ACR stands for adjusted community rate.

Additional benefits are health care services not covered by Medicare, and reductions in premiums or cost-sharing for Medicare covered services, funded from adjusted excess amounts as calculated in the ACR.

Adjusted community rate (ACR) is the equivalent of the maximum amount allowed under § 422.310.

Arrangement means a written agreement between an M+C organization and a provider or provider network, under which

(1) The provider or provider network agrees to furnish for a specific M+C plan(s) specified services to the organization's M+C enrollees;

(2) The organization retains responsibilities for the services; and

(3) Medicare payment to the organization discharges the enrollee's obligation to pay for the services.

Balance billing generally refers to an amount billed by a provider that represents the difference between the amount the provider charges an individual for a service and the sum of the amount the individual's health insurer (for example, the original Medicare program) will pay for the service plus any cost-sharing by the individual.

Basic benefits means all Medicare-covered benefits, except hospice services, and additional benefits.

Benefits are health care services that are intended to maintain or improve the health status of enrollees, for which the M+C organization incurs a cost or liability under an M+C plan,

and that are approved in the Benefit/ ACR process.

Coinsurance is a fixed percentage of the total amount paid for a health care service that can be charged to an M+C enrollee on a per-service basis.

Copayment is a fixed amount that can be charged to an M+C plan enrollee on a per-service basis.

Cost-sharing includes deductibles, coinsurance, and copayments.

Emergency medical condition means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in

(1) Serious jeopardy to the health of the individual or, in the case of a pregnant woman, the health of the woman or her unborn child;

(2) Serious impairment to bodily functions; or

(3) Serious dysfunction of any bodily organ or part.

Emergency services means covered inpatient and outpatient services that

are

(1) Furnished by a provider qualified to furnish emergency services; and

(2) Needed to evaluate or stabilize an emergency medical condition.

Licensed by the State as a risk-bearing entity means the entity is licensed or otherwise authorized by the State to assume risk for offering health insurance or health benefits coverage, such that the entity is authorized to accept prepaid capitation for providing, arranging, or paying for comprehensive health services under an M+C contract.

M+C stands for Medicare+Choice.

M+C eligible individual means an individual who meets the requirements of § 422.50.

M+C_organization means a public or private entity organized and licensed by a State as a risk-bearing entity (with the exception of provider-sponsored organizations receiving waivers) that is certified by HCFA as meeting the M+C contract requirements.

M+C plan means health benefits coverage offered under a policy or contract by an M+C organization that includes a specific set of health benefits offered at a uniform premium and uniform level

of cost-sharing to all Medicare beneficiaries residing in the service area of the M+C plan.

M+C plan enrollee is an M+C eligible individual who has elected an M+C plan offered by an M+C organization.

Mandatory supplemental benefits are services not covered by Medicare that an M+C enrollee must purchase as part of an M+C plan that are paid for directly by (or on behalf of) Medicare enrollees, in the form of premiums or cost-sharing.

MSA stands for medical savings account.

MSA trustee means a person or business with which an enrollee establishes an M+C MSA. A trustee may be a bank, an insurance company, or any other entity that—

(1) Is approved by the Internal Revenue Service to be a trustee or custodian of an individual retirement account (IRA); and

Original Medicare means health insurance available under Medicare Part A and Part B through the traditional feefor service payment system.

Optional supplemental benefits means health benefits normally not covered by Medicare purchased at the option of the M+C enrollee and that are paid for directly by (or on behalf of) the Medicare enrollee, in the form of premiums or cost-sharing. These services may be grouped or offered individually.

Point of service (POS) is a benefit option that an M+C coordinated care plan can offer to its Medicare enrollees as an additional, mandatory supplemental, or optional supplemental benefit. Under the POS benefit option, the M+C plan allows members the option of receiving specified services outside of the M+C plan's provider network. In return for this flexibility, members typically have higher cost-sharing requirements for services received and, where offered as a mandatory or optional supplemental benefit, may also be charged a premium for the POS benefit option. Provider means

(1) Any individual who is engaged in the delivery of health care services in a State and is licensed or certified by the State to engage in that activity in the State; and

(2) Any entity that is engaged in the delivery of health care services in a State and is licensed or certified to deliver those services if such licensing or certification is required by State law or regulation.

Provider network means the providers with which an M+C organization contracts or makes arrangements to furnish covered health care services to Medicare enrollees under an M+C coordinated care or network MSA plan.

Religious and fraternal (RFB) society means an organization that—

(1) Is described in section 501(c)(8) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of that Act; and

(2) Is affiliated with, carries out the tenets of, and shares a religious bond with, a church or convention or association of churches or an affiliated group of churches.

RFB plan means a coordinated care plan that is offered by an RFB society.

Service area means a geographic area approved by HCFA within which an M+C eligible individual may enroll in a particular M+C plan offered by the organization. For coordinated care plans and network medical savings account (MSA) plans only, the service area also is the area within which a network of providers exists that meets the access standards in § 422.112. The service area also defines the area where a uniform benefit package is offered. In deciding whether to approve a service area proposed by an M+C organization for an M+C plan, HCFA considers the M+C organization's commercial service area for the type of plan in question (if applicable), community practices generally, whether the boundaries of the service area are discriminatory in effect, and, in the case of coordinated care and network MSA plans, the adequacy of the provider network in the proposed service area. HCFA may approve single county M+C non-network MSA plans even if the M+C organization has a different commercial service area.

Urgently needed services means covered services provided when an enrollee is temporarily absent from the M+C plan's service (or, if applicable, continuation) area (or, under unusual and extraordinary circumstances, provided

when the enrollee is in the service or continuation area but the organization's provider network is temporarily unavailable or inaccessible) when such services are medically necessary and immediately required—

(1) As a result of an unforeseen illness, injury, or condition; and

(2) It was not reasonable given the circumstances to obtain the services through the organization offering the M+C plan.

§ 422.4 Types of M+C plans.

(a) General rule. An M+C plan may be a coordinated care plan, a combination of an M+C MSA plan and a contribution into an M+C MSA established in accordance with §422.262, or an M+C private fee-for-service plan.

(1) A coordinated care plan. A coordinated care plan is a plan that includes a network of providers that are under contract or arrangement with the organization to deliver the benefit package approved by HCFA.

(i) The network is approved by HCFA to ensure that all applicable requirements are met, including access and availability, service area, and quality.

(ii) Coordinated care plans may include mechanisms to control utilization, such as referrals from a gatekeeper for an enrollee to receive services within the plan, and financial arrangements that offer incentives to providers to furnish high quality and cost-effective care.

(iii) Coordinated care plans include health maintenance organizations (HMOs), provider-sponsored organizations (PSOs) and preferred provider organizations (PPOs), RFBS, and other network plans (except network MSA plans).

(2) A combination of an M+C MSA plan and a contribution into the M+C MSA established in accordance with §422.262. (i) M+C MSA plan means a plan that—

(A) Pays at least for the services described in §422.101, after the enrollee has incurred countable expenses (as specified in the plan) equal in amount to the annual deductible specified in § 422.103(d); and

(B) Meets all other applicable requirements of this part.

(ii) An M+C MSA plan may be either a network plan or a non-network plan.