Exclusions From Medicare and Limitations on Medicare Payment

Basis and scope.

This provision outlines the statutory basis and scope for Medicare payment exclusions and limitations, including physician certification requirements and financial relationship restrictions.

Services required as a result of war.

Medicare does not pay for services required as a result of war or an act of war occurring after the effective date of a beneficiary's coverage.

Basis and scope.

This provision establishes the basis and scope for Medicare secondary payer rules regarding group health plans and beneficiaries with ESRD, age-based, or disability-based entitlement.

Definitions.

This provision defines key terms used in the Medicare secondary payer regulations, including employer, group health plan, and current employment status.

Basic prohibitions and requirements.

This provision outlines prohibitions against group health plans taking into account Medicare entitlement based on ESRD, age, or disability, and mandates equal benefit conditions.

Prohibition against financial and other incentives.

Employers and other entities are prohibited from offering financial incentives to Medicare beneficiaries to discourage enrollment in a group health plan that is primary to Medicare.

Current employment status.

This provision defines current employment status for the purposes of Medicare secondary payer rules, including special rules for self-employed individuals, religious orders, and clergy.

Aggregation rules.

This provision specifies the rules for aggregating employers to determine size and number for Medicare secondary payer requirements.

Taking into account entitlement to Medicare.

This provision defines actions by group health plans that constitute taking into account a beneficiary's Medicare entitlement, which is prohibited under Medicare Secondary Payer rules.

Basis for determination of nonconformance.

This provision outlines the criteria CMS uses to determine if a group health plan is nonconforming with Medicare Secondary Payer statutory requirements.

Documentation of conformance.

This provision specifies the types of documentation CMS may require from a group health plan to demonstrate compliance with Medicare Secondary Payer requirements.

Determination of nonconformance.

This provision establishes the effective dates and special rules for CMS determinations of nonconformance regarding Medicare Secondary Payer obligations.

Notice of determination of nonconformance.

This provision details the notification procedures CMS must follow when determining that a group health plan is nonconforming with Medicare Secondary Payer requirements.

Charges imposed by an immediate relative or member of the beneficiary's household.

This provision excludes Medicare payment for services when the charges are imposed by an immediate relative or a member of the beneficiary's household.

Appeals.

This provision outlines the procedures for requesting a hearing to appeal a CMS determination of nonconformance regarding Medicare Secondary Payer requirements.

Hearing procedures.

This provision outlines the administrative hearing procedures, including discovery, evidence, and subpoena authority, for determinations of nonconformance regarding group health plans.

Hearing officer's decision.

This provision establishes the timeline, content requirements, and binding nature of hearing officer decisions regarding group health plan nonconformance.

Administrator's review of hearing decision.

This provision details the process, criteria, and authority for the CMS Administrator to review hearing officer decisions regarding group health plan nonconformance.

Reopening of determinations and decisions.

This provision specifies the timeframe and authority for reopening previous determinations or decisions regarding group health plan nonconformance.

Referral to Internal Revenue Service (IRS).

This provision outlines the process for CMS to refer nonconforming group health plan determinations to the IRS for tax enforcement purposes.

Particular services excluded from coverage.

The following services are excluded from coverage:

Scope.

This provision defines the applicability of special Medicare rules for individuals with end-stage renal disease.

Prohibition against taking into account Medicare eligibility or entitlement or differentiating benefits.

This provision prohibits group health plans from differentiating benefits or taking into account Medicare eligibility for individuals with end-stage renal disease.

Medicare benefits secondary to group health plan benefits.

This provision establishes the rules for Medicare as a secondary payer for individuals with end-stage renal disease, defining the coordination period during which group health plans remain the primary payer.

Coordination of benefits: Dual entitlement situations.

This provision establishes the rules for determining whether Medicare is the primary or secondary payer when a beneficiary is entitled to Medicare based on both End-Stage Renal Disease (ESRD) and age or disability.

Basis for conditional Medicare payments.

This provision outlines the circumstances under which Medicare may make conditional payments when a group health plan denies a claim or when a beneficiary is unable to file a claim due to incapacity.

General provisions.

This provision defines the rules and criteria for Medicare secondary payer requirements regarding individuals entitled to Medicare on the basis of age and their coverage under employer group health plans.

Medicare benefits secondary to group health plan benefits.

This provision specifies the conditions under which Medicare Part A and Part B benefits are secondary to group health plan benefits for aged individuals covered by virtue of current employment status.

Basis for Medicare primary payments.

This provision identifies the specific scenarios where Medicare acts as the primary payer for services furnished to beneficiaries who are also eligible for group health plan coverage.

Conclusive effect of QIO determinations on payment of claims.

Medicare payment for services is contingent upon meeting quality improvement organization (QIO) review requirements when such review responsibility has been assumed.

Basis and scope.

This provision outlines the statutory basis and scope for Medicare secondary payer rules, identifying insurance types that preclude Medicare payment.

Basis.

This provision establishes that Medicare is secondary to large group health plans for individuals entitled to Medicare on the basis of disability.

Definitions.

This provision defines key terms such as 'entitled to Medicare on the basis of disability' and 'family member' for the purposes of Medicare secondary payer rules.

Medicare benefits secondary to LGHP benefits.

This provision specifies the conditions under which Medicare benefits are secondary to large group health plan benefits for disabled individuals.

Basis for Medicare primary payments and limits on secondary payments.

This provision outlines when CMS makes primary payments for disabled beneficiaries and the conditions for conditional primary payments.

Definitions.

This provision defines terms such as 'conditional payment', 'primary payer', and 'proper claim' for Medicare secondary payer regulations.

Reimbursement obligations of primary payers and entities that received payment from primary payers.

This provision mandates that primary payers and entities receiving payment from them must reimburse CMS when primary payer responsibility is demonstrated.

Beneficiary's cooperation.

This provision requires beneficiaries to cooperate with CMS in recovery actions for conditional payments, with potential recovery from the beneficiary if they fail to do so.

Recovery of conditional payments.

CMS establishes procedures for recovering conditional Medicare payments from primary payers, beneficiaries, and other entities when primary coverage exists.

Primary payer's notice of primary payment responsibility.

Primary payers are required to notify CMS when they have primary payment responsibility for services for which Medicare has made a conditional payment.

Subrogation and right to intervene.

CMS maintains subrogation rights and the authority to intervene in legal actions related to services for which Medicare has made conditional payments.

Waiver of recovery and compromise of claims.

CMS may waive or compromise recovery of conditional payments if the cost of pursuit exceeds the potential recovery amount.

Effect of primary payment on benefit utilization and deductibles.

Services paid by a primary payer do not count against Medicare benefit limits and are credited toward Medicare deductibles.

Authority to bill primary payers for full charges.

Providers may bill primary payers for full charges unless restricted by other laws or specific agreements, regardless of Medicare payment limits.

Basis for Medicare secondary payments.

Medicare makes secondary payments to supplement primary payer payments, subject to specific limitations and filing requirements.

Amount of Medicare secondary payment.

This provision establishes the methodology for calculating Medicare secondary payments when a primary payer is involved, including specific formulas and examples for various service types.

Limitations on charges to a beneficiary or other party when a workers' compensation plan, a no-fault insurer, or an employer group health plan is primary payer.

This provision limits the amounts a provider or supplier may collect from a beneficiary or other parties when a workers' compensation plan, no-fault insurer, or employer group health plan is the primary payer.

Scope of subpart.

This provision outlines the scope of the Stark Law subpart, which prohibits physician referrals for designated health services to entities with which they have a financial relationship.

Definitions.

This section provides the regulatory definitions for terms used in the Stark Law, including designated health services, referrals, fair market value, and value-based arrangements.

Group practice.

This provision defines the requirements for a physician group practice under the Stark Law, including standards for legal structure, physician membership, service range, billing, and compensation methodologies.

Prohibition on certain referrals by physicians and limitations on billing.

This provision prohibits physicians from making referrals for designated health services to entities with which they have a financial relationship and restricts entities from billing Medicare for services resulting from such prohibited referrals.

Financial relationship, compensation, and ownership or investment interest.

This provision defines the financial relationships, compensation arrangements, and ownership interests subject to the physician self-referral (Stark Law) prohibitions and establishes rules for compliance documentation.

General exceptions to the referral prohibition related to both ownership/investment and compensation.

The prohibition on referrals set forth in § 411.353 does not apply to the following types of services:

Exceptions to the referral prohibition related to ownership or investment interests.

Defines specific ownership or investment interests that do not constitute a financial relationship under the physician self-referral prohibition.

Exceptions to the referral prohibition related to compensation arrangements.

For purposes of § 411.353, the following compensation arrangements do not constitute a financial relationship:

Reporting requirements.

Mandates that entities furnishing Medicare services report financial relationships with physicians and their immediate family members to CMS or OIG.

Additional requirements concerning physician ownership and investment in hospitals.

Establishes operational, disclosure, and expansion requirements for hospitals with physician ownership or investment interests.

Process for requesting an exception from the prohibition on facility expansion.

This provision establishes the regulatory process and criteria for hospitals to request an exception from the prohibition on facility expansion, including requirements for data submission, community input, and CMS review.

Amount of Medicare recovery when a primary payment is made as a result of a judgment or settlement.

This provision establishes the methodology for calculating Medicare's recovery amount when a primary payment is made to a beneficiary or provider following a judgment or settlement.

Advisory opinions relating to physician referrals.

This provision outlines the scope, eligibility, and limitations for requesting CMS advisory opinions regarding physician referral arrangements under the Stark Law.

Procedure for submitting a request.

This provision details the required format, information, and documentation necessary for submitting a formal request for a CMS advisory opinion on physician referral arrangements.

Certification.

This provision mandates specific signed certifications regarding the truthfulness of information and the good-faith intent of proposed arrangements for advisory opinion requests.

Fees for the cost of advisory opinions.

This provision establishes the hourly fee structure and payment obligations for parties requesting CMS advisory opinions.

Expert opinions from outside sources.

This provision authorizes CMS to engage outside experts for advisory opinion requests and mandates that the requestor bear the associated costs.

Withdrawing a request.

Parties may withdraw an advisory opinion request before CMS issues a formal opinion, though they remain responsible for processing costs incurred by the Department.

When CMS accepts a request.

CMS evaluates advisory opinion requests for sufficient detail and formally notifies the requestor upon acceptance, which triggers the regulatory timeline for issuance.

When CMS issues a formal advisory opinion.

CMS issues formal advisory opinions within specified timeframes after receiving payment and formally accepting a request, subject to potential suspensions for additional information or expert advice.

CMS' right to rescind advisory opinions.

CMS may rescind or revoke an advisory opinion for good cause, such as material changes in law, while providing protections for parties who relied on the opinion in good faith.

Disclosing advisory opinions and supporting information.

CMS makes issued advisory opinions publicly available on its website, while protecting certain predecisional documents from disclosure under the Freedom of Information Act.

CMS's advisory opinions as exclusive.

The established CMS advisory opinion process is the sole method for obtaining a binding advisory opinion regarding physician self-referral.

Effect of an advisory opinion.

A favorable advisory opinion is binding on the Secretary and precludes sanctions for the requesting party and parties to the specific arrangement, while serving as non-binding guidance for others.

When advisory opinions are not admissible evidence.

The failure to seek or receive an advisory opinion cannot be used as evidence of intent to violate specific Medicare fraud and abuse statutes.

Range of the advisory opinion.

CMS advisory opinions are limited to the specific subject matter requested and do not bind other agencies or affect obligations under other laws.

Automobile and liability insurance (including self-insurance), no-fault insurance, and workers' compensation: Final conditional payment amounts via Web portal.

This provision establishes the process for beneficiaries, attorneys, and applicable plans to access and resolve Medicare conditional payment information via the Medicare Secondary Payer Recovery Portal.

Items and services for which neither the beneficiary nor any other person is legally obligated to pay.

This provision defines the conditions under which Medicare will not pay for items or services when there is no legal obligation for the beneficiary or another party to pay, including specific rules for individuals in penal custody.

General provisions.

This provision outlines the limitations on Medicare payment when services are covered by workers' compensation plans or the Federal Black Lung Program.

Payment for custodial care and services not reasonable and necessary.

This provision sets the conditions for Medicare payment for custodial care and services not considered reasonable and necessary, including time limits for post-discharge care planning.

Indemnification of beneficiary.

This provision outlines the conditions and process for indemnifying a beneficiary when Medicare payment is precluded for services that the provider knew or should have known were not covered.

Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary.

This provision establishes the criteria for determining when a Medicare beneficiary is considered to have known that services were excluded from coverage as custodial care or as not reasonable and necessary.

Criteria for determining that a provider, practitioner, or supplier knew that services were excluded from coverage as custodial care or as not reasonable and necessary.

This provision outlines the conditions under which a provider, practitioner, or supplier is considered to have known that services were excluded from Medicare coverage as custodial care or as not reasonable and necessary.

Refunds of amounts collected for physician services not reasonable and necessary, payment not accepted on an assignment-related basis.

This provision mandates that physicians refund amounts collected for services denied by Medicare as not reasonable and necessary, unless specific waiver criteria are met.

Beneficiary's responsibility with respect to workers' compensation.

This provision requires beneficiaries to pursue workers' compensation remedies before Medicare payment is made for related services.

Basis for conditional Medicare payment in workers' compensation cases.

This provision outlines the circumstances under which Medicare may make conditional payments when workers' compensation claims are pending or denied.

Lump-sum payments.

This provision specifies how lump-sum workers' compensation settlements affect Medicare's responsibility for future medical expenses.

Apportionment of a lump-sum compromise settlement of a workers' compensation claim.

This provision establishes the methodology for apportioning lump-sum workers' compensation settlements to determine Medicare's payment liability and overpayment amounts.

General provisions.

Defines key terms and scope for Medicare payment exclusions related to liability, no-fault, and self-insured insurance plans.

Beneficiary's responsibility with respect to no-fault insurance.

Outlines the beneficiary's obligation to pursue no-fault insurance payments before Medicare will provide coverage.

Basis for conditional Medicare payment in liability cases.

Specifies the conditions under which Medicare may make a conditional payment when a liability insurance claim is pending or denied.

Basis for conditional Medicare payment in no-fault cases.

Defines the circumstances under which Medicare may issue a conditional payment for services covered by no-fault insurance.

Limitation on charges when a beneficiary has received a liability insurance payment or has a claim pending against a liability insurer.

Sets requirements for hospitals regarding itemized billing and charge limitations when a beneficiary has a pending liability insurance claim.

Services furnished by a Federal provider of services or other Federal agency.

States the general rule that Medicare does not pay for services provided by Federal agencies, with specific exceptions for emergency and community-based services.

Services that must be furnished at public expense under a Federal law or Federal Government contract.

Prohibits Medicare payment for services that providers are legally obligated to furnish at public expense under federal law or contract.

Services paid for by a Government entity.

Establishes that Medicare does not pay for services already covered by a government entity, while providing specific exceptions for community hospitals and infectious disease control.

Services furnished outside the United States.

States the general rule that Medicare does not pay for services furnished outside the U.S., with limited exceptions for specific inpatient hospital services.