Fraud & Abuse Waivers Under the Medicare Shared Savings Program

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1 Fraud & Abuse Waivers Under the Medicare Shared Savings Program Robert G. Homchick Davis Wright Tremaine, LLP I. Introduction The Patient Protection and Affordable Care Act of 2010 (ACA) fosters the development of new patient care models designed to improve the coordination, quality and efficiency of health care services to Medicare and Medicaid patients. Section 3022 of the ACA mandates the creation of the Medicare Shared Savings Program, which allows qualified groups of providers to earn a share of the savings generated as a result of reducing the overall cost of providing care to an assigned population of Medicare fee-for-service beneficiaries. To participate in the Shared Savings Program providers band together to form Accountable Care Organizations ( ACOs ). To facilitate the establishment of ACOs, the ACA grants the Secretary of Health and Human Services the authority to waive certain provisions of the fraud and abuse laws under the Social Security Act or other provisions of the Medicare law (herein ACO waivers ). The Centers for Medicare & Medicaid Services (CMS) released the final ACO regulations on October 20, At the same time, CMS and HHS Office of Inspector General (OIG) published an Interim Final Rule with Comment ( IFC ) establishing waivers of the Stark law, the anti-kickback statute, and certain provisions of the civil money penalty law (CMP), including the so called Gainsharing CMP and the prohibition on inducements to beneficiaries. The IFC establishes five separate waivers that when considered in the aggregate permit ACOs significantly more latitude than under the waivers proposed by CMS and OIG earlier this year. The specific waivers set forth in the IFC include: An ACO pre-participation waiver that applies to ACO-related start-up arrangements; An ACO participation waiver that applies during the period of when the entity is actively participating in the Shared Savings Program and for a limited time thereafter; A patient incentive waiver for in kind incentives offered by ACOs to beneficiaries to encourage preventive care and compliance with treatment regimens; A shared savings distribution waiver; and A compliance with Stark Law waiver. The last two waivers were included in the ACO waiver proposal released by CMS and OIG last spring. The first three are new. Under the IFC the fraud & abuse waivers are contingent on documentation and governing body approvals as well as possible public disclosure requirements. 1

2 II. Applicable Fraud and Abuse Laws Section 3022(f) of the ACA grants the Secretary the authority to waive those requirements of Sections 1128A and B and Title XVIII of the Social Security Act as may be required to carry out the Shared Savings Program provisions. These provisions include: o Gainsharing CMP or the Civil Money Penalty Law Prohibition on Payments to Reduce or Limit Care, 42 U.S.C. 1320a 7a(b). A hospital or critical access hospital may not knowingly make a payment, directly or indirectly to a physician as an inducement to reduce or limit services provided to a Medicare or Medicaid beneficiary under the direct care of the physician. o Beneficiary Inducement CMP or the Civil Money Penalty Law Prohibition on Inducements to Beneficiaries, 42 U.S.C. 1320a 7a(a)(5). Persons may not provide remuneration to a Medicare or Medicaid beneficiary where the person knows or should know that the remuneration is likely to influence the beneficiary to order or receive a service from a particular provider, practitioner or supplier where the item may be covered in whole or in part under the Medicare or Medicaid program. o The Stark Law, 42 U.S.C. 1395nn. A physician may not refer Medicare patients for certain designated health services to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. An entity receiving a prohibited referral may not bill the Medicare program for the resulting items and services. o The Anti-Kickback Statute, 42 U.S.C. 1320a 7b(b)(1) and (2). Persons may not knowingly offer or receive, directly or indirectly, overtly or covertly, in cash or in kind, any remuneration to induce or influence the furnishing, arrangement, purchase, leasing, or ordering of items or services for which payment may be made in whole or in part under a federal health care program. o Prohibitions Against Charging or Collecting More Than the Medicare Allowable, 42 U.S.C.1320a-7a(a)(2). Assignment occurs when a beneficiary asks that a Medicare payment be made directly to the provider. If a provider accepts assignment, Medicare will directly pay the fee schedule amount for the services, and the beneficiary will be responsible for paying the coinsurance and any remaining deductible. Collectively, the fee schedule payment and coinsurance/deductible are referred to as the allowed amount. By accepting assignment, the provider agrees to accept the allowed amount as payment in full for the services. 2

3 III. The Establishment, Scope and Application of the Waivers Secretary Determination. The IFC reflects the determination by the Secretary that it is necessary to waive certain provisions of the Stark law, the Federal anti-kickback statute, the Gainsharing CMP and the Beneficiary Inducements CMP to carry out the Shared Savings Program. This finding was the necessary predicate to the establishment of the waivers. Scope of Waivers. The waivers set forth in the IFC are promulgated pursuant to the specific authority granted the Secretary under the ACA and apply only to the Shared Savings Program and participating ACOs. The ACA includes separate authority for Secretary to waive fraud and abuse laws for other demonstration projects and pilot programs. The agencies will issue separate guidance addressing waivers under other programs. The waivers only apply to the specific laws identified in the IFC (i.e. Stark, anti-kickback and CMPs) and not to any other provision of State or Federal law, including the Internal Revenue Code. Uniform Application. The waivers apply uniformly to all ACOs, ACO participants and ACO provider/suppliers. Automatic Application. The waivers apply automatically if the conditions are satisfied. There is no need for participants in the Shared Savings Program to apply for an individualized waiver. Joint Issuance. In a noteworthy display of interagency cooperation, CMS and OIG jointly established the waivers under the IFC thereby adopting a coordinated approach to the waivers of the fraud and abuse laws under the Shared Savings Program. Because the waivers address several different laws and are subject to modification the Secretary elected not to publish the waivers in the Code of Federal Regulations to better ensure that the waivers are consistent over time. Purposes of the Shared Savings Program. The Pre-participation Waiver and the Participation Waiver require that the covered arrangement be for purposes of the Shared Savings Program. That phase is broadly defined in the IFC to include promoting accountability for the quality and cost of overall care for the Medicare patient population, managing and coordinating such care and encouraging investment in infrastructure and redesigned care processes. IV. The Five Waivers The IFC establishes five separate waivers addressing different circumstances or aspects of the formation and operations of an ACO. An arrangement need only fit within one waiver to be protected but in some cases an arrangement may satisfy the criteria of more than one waiver. 3

4 A. ACO Pre-participation Waiver The Stark law, anti-kickback statute and Gainsharing CMP are waived with respect to start up arrangements that pre-date an ACO s participation in the Shared Savings Program, provided: 1. The parties have a good faith intent to develop an ACO that will participate in the Shared Savings Program starting in a particular year and to submit an application to participate in that year; 2. The parties must take diligent steps to develop an ACO; 3. ACO s governing body must make a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program; 4. Documentation of the arrangement, the governing body s determination and related matters are contemporaneously maintained and retained by the ACO for at least 10 years; and 5. A description of the arrangement is publicly disclosed at a time and in a manner established in guidance to be issued by the Secretary. B. ACO Participation Waiver The Stark law, anti-kickback statute and Gainsharing CMP are waived with respect to any arrangement of an ACO, its ACO participants and ACO providers/suppliers provided: 1. The ACO has entered into a participation agreement and remains in good of an ACO; 2. The ACO meets the governance, leadership and management requirements 3. The ACO s governing body has made a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program; 4. Documentation of the arrangement, the governing body s determination and related matters are contemporaneously maintained and retained by the ACO for at least 10 years; and 5. A description of the arrangement is publicly disclosed at a time and in a manner established in guidance to be issued by the Secretary. C. Shared Savings Distribution Waiver The Stark law, anti-kickback statute and Gainsharing CMP are waived with respect to distributions of shared savings earned by an ACO, provided: 4

5 1. The ACO has entered into a participation agreement and remains in good Program; 2. The shared savings are earned by the ACO pursuant to the Shared Savings 3. The shared savings are earned by the ACO during the term of its participation agreement, even if the distribution or use of the shared savings occurs after expiration of the agreement; 4. The shared savings are either distributed among ACO participants, ACO provided/suppliers or used for activities that are reasonably related to the purposes of the Shared Savings Program; and 5. With respect to the Gainsharing CMP waiver, the shared savings distributions made directly or indirectly from a hospital to a physician may not be knowingly made to reduce or limit medically necessary care to patients under the direct care of the physician. The IFC clarifies that payments to encourage best practices or compliance with clinical protocols are not prohibited by this provision. D. Compliance with Stark Law Waiver The Gainsharing CMP and the anti-kickback statute are waived with respect to any financial relationship among the ACO, its participants, and its ACO providers/suppliers that implicates the Stark law, provided: 1. The ACO has entered into a participation agreement and remains in good 2. The financial relationship is reasonably related to the purposes of the Shared Savings Program; and 3. The financial relationship fits within an exception to the Stark law. E. Waiver for Patient Incentives The Beneficiary Inducement CMP and the anti-kickback statute are waived with respect to items or services provided by an ACO, its ACO participants, or its ACO providers/suppliers to beneficiaries for free or below fair market value provided: 1. The ACO has entered into a participation agreement and remains in good 2. There is a reasonable connection between the items or services and the medical care of the beneficiary; 5

6 and 3. The items or services are in kind (no cash or cash equivalent payments); 4. The items and services are (a) preventive care; or (b) advance one or more of the following goals: (i) adherence to a treatment regime; (ii) adherence to a drug regime; (iii) adherence to a follow-up plan of care; (iv) management of a chronic disease or condition. V. Request for Comment The IFC requests comment on the scope and duration of the waivers. All comments are due within 60 days of the date the IFC is published in the Federal Register. 6