Analisando a aplicação da Lei Federal Antissuborno aos pagamentos a agentes e corretores do Medicare Advantage

On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations (MAOs), their agents and brokers, and health care professionals (HCPs).[1] This blog post will unpack OIG’s commentary on these arrangements and discuss how – and if – the federal Anti-Kickback Statute (AKS) applies to them. 

The first section provides a brief background on the Centers for Medicare & Medicaid Services’ (CMS) regulations applicable to compensation for agents and brokers for MA plans with a focus on the regulations that were to be effective for Contract Year 2025 but have been stayed (i.e., delayed) pending the outcome of court cases in the Northern District of Texas. The second section provides an overview of OIG’s 2024 Alert, and the final section explores the application of the AKS to arrangements involving payments to MA plan agents and brokers.

CMS Revised Agent, Broker & TPMO Compensation Regulations

By statute, CMS is given regulatory authority over MA agent and broker compensation – see Social Security Act (SSA) § 1851(j)(2)(D), 42 U.S.C. § 1395w-21(j)(2)(D) – which describes prohibited activities and limitations related to eligibility, election, and enrollment, including “[t]he use of compensation other than as provided under guidelines established by the Secretary. Such guidelines shall ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs.” That statutory authority is implemented through CMS regulation at 42 C.F.R. § 422.2274, which addresses MA plan payments to agents and brokers. 

In its April 2024 Final Rule revising section 422.2274, CMS outlined the following approach for revisions to the agent, broker and third-party marketing organization (TPMO) compensation structures:

1. generally prohibit contract terms between MA organizations and agents, brokers or other TPMOs that may interfere with the agent’s or broker’s ability to objectively assess and recommend the plan which best fits a beneficiary’s health care needs;
2. set a single agent and broker compensation rate for all plans, while revising the scope of what is considered “compensation”; and
3. eliminate the regulatory framework which currently allows for separate payment to agent and brokers for administrative services.[2]

In several places in the Final Rule, CMS noted that, depending on the circumstances, agent and broker relationships can also be problematic under the AKS if they involve, for example, compensation in excess of fair market value (FMV), compensation structures tied to the health status of the beneficiary (e.g., cherry picking for the most profitable enrollees), or compensation that varies based on the attainment of certain enrollment targets.[3] 

On July 3, 2024, the U.S. District Court for the Northern District of Texas issued preliminary injunctions in Americans for Beneficiary Choice v. HHS, No. 4:24-cv-00439, and Council for Medicare Choice v. HHS, No. 4:24-cv-00446, which stayed for the duration of the litigation the effective date of certain of the provisions of the revised CMS agent/broker/TPMO compensation provisions, specifically, those amending 42 C.F.R. § 422.2274(a), (c), (d), (e) (and for Medicare Part D at § 423.2274(a), (c), (d) and (e)). Therefore, the regulatory language within those subsections that were effective prior to the issuance of the final rule will be in effect in Contract Year 2025 so long as the stay remains in place.[4]

To be clear, with or without the revisions to the compensation provisions, the agent, broker and TPMO compensation regulations at 42 C.F.R. § 422.2274 currently and as revised allow compensation that is quite different than what is reflected in the AKS safe harbors and OIG guidance on the provider side. For example, the CMS regulations allow per enrollment fees to brokers or agents based on successfully enrolling beneficiaries into MA plans (a “success fee”), which have caps set at “fair market value” amounts (defined in the regulation) determined by CMS.[5] Further, payments for referrals (up to $100) are specifically allowed (e.g., a lead fee) for the “recommendation, provision, or other means of referring beneficiaries to an agent, broker or other entity for potential enrollment into a plan.”[6] These compensation methodologies have been commonplace in the insurance market for decades, but they are quite different than sales agent compensation for providers that are paid by the federal health care programs.

Overview: OIG Special Fraud Alert

In the wake of CMS’ Final Rule, OIG released a Special Fraud Alert, which focuses on: 

• marketing arrangements between MAOs and HCPs and
• arrangements between HCPs and agents and brokers for MA plans.[7]

The Alert illustrates how OIG views the application of AKS in arrangements between HCPs and agents and brokers for MA plans.

OIG noted that a substantial area of risk involves MAOs, directly or indirectly, paying remuneration (i.e., anything of value) to HCPs or their staff in exchange for referring patients to the MAOs’ plans.[8] OIG acknowledged that CMS regulations allow HCPs to engage in certain limited marketing related functions on behalf of an MAO, but MAOs must ensure that HCPs acting on their behalf do not “[a]ccept compensation from the [MAO] for any marketing or enrollment activities performed on behalf of the [MAO],”[9] citing a CMS regulation. (The OIG cited a recent Department of Justice settlement for $60 million involving alleged kickbacks paid to insurance agents in Medicare Advantage patient recruitment.[10])

The Alert noted that the second area of risk involves payments from HCPs to agents and brokers, e.g., payments from an HCP to agents and brokers to recommend that HCP to a particular MA enrollee or refer to the enrollee to the HCP.[11] According to OIG, in some cases, HCPs make these payments to refer Medicare enrollees to the HCP, in return to become designated as the primary care provider for the enrollee at their particular MA plan.[12]

OIG is concerned that agents, brokers and HCPs may skew the guidance they provide related to HCPs or MA plans based on their financial self-interest.[13] When a party knowingly and willfully pays remuneration to induce or reward referrals of items or services payable by a federal health care program, the AKS may be implicated.[14] By its terms, the statute ascribes liability to parties on both sides of an impermissible kickback transaction. Arrangements involving HCP compensation to an agent or broker could implicate the statute if the HCP offers or pays an agent or broker to refer enrollees to the HCP for the furnishing or provision of items or services that are reimbursable by a federal health care program.[15] Similarly, arrangements involving MAO compensation to an HCP or their staff could implicate the statute if the MAO offers and pays an HCP or their staff to refer enrollees to a particular MA plan to furnish or arrange for the furnishing of items or services that are reimbursable by Medicare.[16] 

Based on its experience, OIG provides a list of “suspect characteristics” that “taken together or separately, could suggest that an arrangement presents a heightened risk of fraud and abuse.”[17] These characteristics include, but are not limited to:

• MAOs, agents, brokers, or any other individual or entity offering or HCPs or their staff remuneration (such as bonuses or gift cards) in exchange for referring or recommending patients to a particular MAO or MA plan.
• MAOs, agents, brokers, or any other individual or entity offering or paying HCPs remuneration that is disguised as payment for legitimate services but is actually intended to be payment for the health care provider’s referral of individuals to a particular MA plan.
• MAOs, agents, brokers, or any other individual or entity offering or paying HCPs or their staff remuneration in exchange for sharing patient information that may be used by the MAOs to market to potential enrollees.
• MAOs, agents, brokers, or any other individual or entity offering or paying remuneration to HCPs that is contingent upon or varies based on the demographics or health status of individuals enrolled or referred for enrollment in an MA plan.
• MAOs, agents, brokers, or any other individual or entity offering or paying remuneration to HCPs that varies based on the number of individuals referred for enrollment in an MA plan.
• HCPs offering or paying remuneration to an agent, broker, or other third party that is contingent upon or varies based on the demographics or health status of individuals enrolled or referred for enrollment in an MA plan.
• HCPs offering or paying remuneration to an agent, broker, or other third party to recommend that HCP to a Medicare enrollee or refer an enrollee to the HCP.
• HCPs offering or paying remuneration to an agent, broker, or other third party that varies with the number of individuals referred to the HCP.[18]

Application of the Federal AKS to Arrangements Involving Agents and Brokers for MA Plans

On the provider side, the AKS is well known and should be carefully navigated. The AKS prohibits providers from knowingly and willfully soliciting, receiving, offering, or paying, directly or indirectly, any remuneration in return for either making a referral for an item or service covered by a federal health care program (including Medicare and Medicaid) or ordering any covered item or service.[19] For purposes of this statute, remuneration includes the transfer of anything of value, in cash or in kind, directly or indirectly, covertly or overtly.[20] OIG has promulgated AKS regulations, which provide safe-harbor protection for certain activities that might otherwise be subject to scrutiny under the AKS.[21] If a safe harbor applies to an arrangement, it must satisfy all elements of the safe harbor to receive protection. If an arrangement does not fall within a safe harbor, OIG will review the full facts and circumstances to make a compliance determination.

In the Alert, OIG suggests that financial arrangements involving agents and brokers for MA plans may implicate the AKS. Arrangements involving HCP compensation to an agent or broker could implicate the statute if the HCP offers or pays an agent or broker to refer enrollees to the HCP for the furnishing or provision of items or services that are reimbursable by a federal health care program.[22] Similarly, arrangements involving MAO compensation to an HCP or their staff could implicate the AKS if the MAO offers and pays an HCP or their staff to refer enrollees to a particular MA plan to furnish or arrange for the furnishing of items or services that are reimbursable by Medicare.[23] 

However, the AKS’s application to agent/broker arrangements is murky territory, which we explore further below.

i.  AKS History

In 1972, the federal AKS was created in two (2) identically worded sections of the SSA in title XVIII (SSA § 1877) (Medicare) and title XIX (SSA § 1909) (Medicaid). Until 1999, there were Parts A and B of Medicare, but no Part C – i.e., no Medicare Advantage (previously called Medicare+Choice).[24] The AKS prohibition related then, as it does now, to referrals of “items or services” and purchasing, leasing, ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part “under the [Medicare and Medicaid] title.” (That payor language is now “under a Federal health care program.”[25])

The Medicare definitions for that original SSA section 1877 were found in SSA section 1861 (42 U.S.C. § 1395x) (under Part E – Miscellaneous Provisions). Under the Medicare definitions (SSA Sec. 1861 Definition of services, institutions, etc.), “item or service” is not specifically defined, but there are references to its meaning in the other definitions in that section. For example, SSA section 1861(n) “The term ‘physicians’ services means professional services performed by physicians, including surgery, consultation, and home, office, and institutional calls….”[26] SSA section 1861(s) “The term ‘medical and other health services’ means any of the following items or services: (1) physician services; (2)(A) services and supplies…; (B) hospital services…(C) diagnostic services….”[27]

In 1987, Congress moved SSA section 1909 to section 1128B and repealed the anti-kickback provisions of SSA section 1877. (Remember SSA sections 1877 and 1909 were identically worded.) SSA section 1128B is under SSA title XI (General Provisions, Peer Review and Administrative Simplification) and does not have a definition of “item or service.”[28] However, the definitions section under SSA title XVIII (Medicare) at section 1861 still exist. Further, and as previously noted, in 1999, Medicare Part C (also known as Medicare+Choice, now Medicare Advantage) was created and is part of the SSA title XVIII.

The meanings of items or services have remained at SSA title XVIII, section 1861 (entitled “Definitions”). As such, items include, e.g., prescription drugs and supplies; services include, e.g., physician services. Items and services have never been interpreted as being a Medicare Advantage plan itself. 

ii.  Agent/Broker Payments

Payments tied to marketing for enrollment of beneficiaries into an MA plan do not implicate the AKS because such plan marketing services are not referrals of items or services nor are such plan marketing services purchasing, leasing, ordering or arrangement for or recommending purchasing, leasing, or ordering any good, facility, service or item.

AKS does apply to health plans, but in looking at the AKS regulatory safe harbors (the OIG’s implementing regulations), it is clear that the statute’s application (and the meaning of items and services), does not include marketing and other pre-enrollment activities.

1. 42 C.F.R. §  1001.952(l) Increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans. “(1) As used in section 1128B of the Act, ‘remuneration’ does not include the additional coverage of any item or service offered by a health plan to an enrollee or the reduction of some or all of the enrollee’s obligation to pay the health plan or a contract health care provider for cost-sharing amounts (such as coinsurance, deductible, or copayment amounts) or for premium amounts attributable to items or services covered by the health plan, the Medicare program, or a State health care program, as long as the health plan complies with all of the standards within one of the following two categories of health plans….”

2. 42 C.F.R. §  1001.952(m) Price reductions offered to health plans. “As used in section 1128B of the Act, ‘remuneration’ does not include a reduction in price a contract health care provider offers to a health plan in accordance with the terms of a written agreement between the contract health care provider and the health plan for the sole purpose of furnishing to enrollees items or services that are covered by the health plan, Medicare, or a State health care program, as long as both the health plan and contract health care provider comply with all of the applicable standards within one of the following four categories of health plans….”

3. 42 C.F.R. § 1001.952(t) Price reductions offered to eligible managed care organizations. “(1) As used in section 1128B of the Act, ‘remuneration’ does not include any payment between: (i) an eligible managed care organization and any first tier contractor for providing or arranging for items or services, as long as the following three standards are met — (A) the eligible managed care organization and the first tier contractor have an agreement that: (1) Is set out in writing…. 

            (2) For purposes of this paragraph, the following terms are defined as follows:

…(iv) Items and services means health care items, devices, supplies or services or those services reasonably related to the provision of health care items, devices, supplies or services including, but not limited to, non-emergency transportation, patient education, attendant services, social services (e.g., case management), utilization review and quality assurance. Marketing and other pre-enrollment activities are not “items or services” for purposes of this section.”

4. 42 C.F.R. § 1001.952(u) Price reductions offered by contractors with substantial financial risk to managed care organizations. “(1) As used in section 1128(B) of the Act, “remuneration” does not include any payment between: (i) A qualified managed care plan and a first tier contractor for providing or arranging for items or services, where the following five standards are met — (A) The agreement between the qualified managed care plan and first tier contractor must: (1) Be in writing and signed by the parties;….

(2) For purposes of this paragraph, the following terms are defined as follows:

…(iv) Items and services means health care items, devices, supplies or services or those services reasonably related to the provision of health care items, devices, supplies or services including, but not limited to, non-emergency transportation, patient education, attendant services, social services (e.g., case management), utilization review and quality assurance. Marketing or other pre-enrollment activities are not “items or services” for purposes of this definition in this paragraph.”

Except for the Alert discussed in this Article, there is no OIG regulatory or sub-regulatory guidance providing direction related to MA plan-agent/broker arrangements. The recent Alert discusses arrangements involving MAO compensation to an HCP or their staff that could implicate AKS if the MAO offers and pays an HCP or their staff to refer enrollees to a particular MA plan to furnish or arrange for the furnishing of items or services that are reimbursable by Medicare. The Alert’s analysis concludes applicability of the AKS while it jumps past (or around) the “conduct” – i.e., the recommendation of the MAO plan enrollment – to the items and services provided by a plan.

Prior to the most recent Alert, OIG’s last discussion of such arrangements was in 1996 (even before MA) and noted that the issue of independent agents and brokers in the managed care arena was beyond the scope of the 1996 final rule (regarding safe harbors for protecting health plans) and “would require separate notice and public comment in order to be adopted.”[29] There has been no such separate notice and comment.

The 2008 and 2024 rules from CMS noted that “agents and broker relationships can be problematic under the federal anti-kickback statute if they involve, by way of example only, compensation in excess of fair market value, compensation structures tied to the health status of the beneficiary (for example, cherry picking), or compensation that varies based on the attainment of certain enrollment targets.”[30] OIG, not CMS, has authority to interpret the AKS and its safe harbors. Thus, this CMS preamble language is interesting, but it is not OIG guidance, or more fundamentally a statutory expansion that would apply the AKS to incentives related to MA plan choices.

In the 2024 Final Rule, in its discussion of AKS, CMS also referenced a 2010 OIG report, but that 2010 report specifically stated: “Finally, we [OIG] did not determine whether plan sponsors’ payments complied with the Federal anti-kickback statute. A legal analysis of whether plan sponsor payments violated the Federal anti-kickback statute was beyond the scope of this study.”[31] 

Conclusão

The AKS is broadly applicable to items and services provided by the federal health care programs, but it is not currently applicable to MA broker and agent compensation related to MA plan choices that are not “items and services.” CMS has broad authority related to MA broker, agent and TPMO compensation by statute and regulation. Without a statutory change to the AKS, CMS is the sole authority over MA broker, agent and TPMO compensation in accordance with the rules set forth at 42 C.F.R. § 422.2274.
 

[1] U.S. Dep’t. of Health & Hum. Servs. Office of Inspector General, Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers (Dec. 11, 2024) (available at https://oig.hhs.gov/compliance/alerts/).

[2] 89 Fed. Reg. 30,448, 30,620 (CMS Final Rule, Apr. 23, 2024).

[3]Id. at 30,617, 30,618 and 30,624.

[4] CMS, Medicare Drug and Health Plan Contract Administration Group, UPDATED Contract Year 2025 Agent and Broker Compensation Rates, Submissions, and Training and Testing Requirements (July 18, 2024) available at https://22041182.fs1.hubspotusercontent-na1.net/hubfs/22041182/Memo_Updated%20AB%20Compensation%20and%20T%20and%20Testing%20Requirements%20CY2025_Final.pdf. 

[5] 42 C.F.R. § 422.2274(a), (d).

[6]Id. § 422.2274(f).

[7] U.S. Dep’t. of Health & Hum. Servs. Office of Inspector General, Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers (Dec. 11, 2024), available at https://oig.hhs.gov/documents/special-fraud-alerts/10092/Special%20Fraud%20Alert:%20Suspect%20Payments%20in%20Marketing%20Arrangements%20Related%20to%20Medicare%20Advantage%20and%20P.pdf (hereinafter, “Alert”). 

[8]Id. at 2.

[9] 42 C.F.R. § 422.2266.

[10]See Press Release, U.S. Department of Justice, Oak Street Health Agrees to Pay $60 Million to Resolve Alleged False Claims Act Liability for Paying Kickbacks to Insurance Agents in Medicare Advantage Patient Recruitment Scheme (Sept. 18, 2024), https://www.justice.gov/opa/pr/oak-street-health-agrees-pay-60m-resolve-alleged-falseclaims-act-liability-paying-kickbacks.

[11] Alert at 2.

[12]Id.

[13]Id. at 3.

[14]Id. at 4.

[15]Id.

[16]Id.

[17]Id. at 5.

[18]Id.

[19] SSA 1128B(b)(1), 42 U.S.C. § 1395a-7b(b)(1).

[20]Id.

[21] 42 C.F.R. § 1001.952.

[22] Alert at 4.

[23]Id.

[24]See Balance Budget Act of 1997, P. L. 105-33, 111 Stat. 251, tit. IV (Aug. 5, 1997).

[25] “Federal health care program” is defined as “(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5); or (2) any State health care program, as defined in section 1320a-7(h) of this title.” SSA 1128B(f), 42 U.S.C. § 1320a-7b(f).

[26] SSA § 1861(n), 42 U.S.C. § 1395x(n).

[27] SSA § 1861(s), 42 U.S.C. § 1395x(s).

[28]See generally SSA § 1861, 42 U.S.C. § 1395x.

[29] 61 Fed. Reg. 2122, 2124 (OIG Final Rule, Jan. 25, 1996).

[30]See, e.g., 89 Fed. Reg. 30,448, 30,617 (Final Rule, Apr. 23, 2024).

[31] 89 Fed. Reg. at 30,618 (citing Levinson, Daniel R, Beneficiaries Remain Vulnerable to Sales Agents Marketing of Medicare Advantage Plans (March 2010), https://oig.hhs.gov/oei/reports/oei-05-09-00070.pdf)).