Specific waivers exist to allow ACOs[1] to operate without the risk of liability under specific fraud and abuse laws. There are five waivers of those fraud and abuse laws in connection with the Next Generation ACO Model:

• Next Generation ACO Participation Waiver
• Shared Savings Distribution Waiver
• Compliance with the Physician Self-Referral Law (Stark) Waiver
• Patient Engagement Incentives Waiver
• AIPBP Payment Arrangement Waiver

ACOs can take advantage of the above waivers, provided they meet the requirements outlined in the waiver.

The penalties for violating federal anti-fraud laws can be severe, including high dollar civil penalties to the individual and organizations violating the law, as well as criminal penalties (fines and jail imposed under 42 U.S. Code § 1320a–7b). Because of the high risks associated with inadvertently violating federal anti-fraud laws, ACOs must carefully review their initiative and waiver requirements to avoid violations. Also, ACOs should also audit for continual compliance with waivers, since arrangements are sometimes modified over time.

Be mindful that the ACO Next Generation waivers only apply to the specific federal laws. They do not act as waivers of state fraud laws. For more information on the high risk federal anti-fraud laws, see our article entitled Fraud and Abuse Risk Raised by Next Generation ACO Structure.

Detail information on the waivers can be found in the Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model, dated December 29, 2016. Below is a summary of the five available waivers.

Next Generation ACO Participation Waiver

Physician self-referral law (Stark) and Anti-Kickback Statute are waived concerning any arrangement of the Next Generation ACO, one or more of its Next Generation Participants, or a combination thereof, provided that all of the following conditions are met:

• The ACO remains in good standing under the Participation Agreement.
• The ACO meets the requirements concerning its governance, leadership, and management.
• The ACO governing body has made and duly authorized a bona fide determination that the arrangement is reasonably related to ACO Activities.

Next Generation ACO Participation Waiver Documentation Requirements

1. Both the arrangement and its authorization by the governing body must be documented.
2. The documentation of the arrangement must be contemporaneous with the establishment of the arrangement, and the documentation of the authorization must be contemporaneous with the authorization.
3. All such documentation must be retained for at least ten years following the completion of the arrangement.
4. Documentation should include:
   1. A description of the arrangement, including:
      1. All parties to the arrangement;
      2. Date of the arrangement;
      3. Purpose of the arrangement;
      4. Items, services, facilities, and goods covered by the arrangement (including nonmedical items, services, facilities, or goods); and
      5. Financial or economic terms of the arrangement.

1. The date and manner of the governing body’s authorization of the arrangement.
2. The documentation should include the basis for the determination by the Next Generation ACO’s governing body that the arrangement is reasonably related to ACO Activities.

Shared Savings Distribution Waiver

Physician self-referral law (Stark) and Anti-Kickback Statute are waived concerning distributions or use of Shared Savings earned by the ACO Health Plan ACO of Ohio, provided that all of the following conditions are met:

• The ACO remains in good standing under the Participation Agreement.
• The Shared Savings are earned under the Next Generation ACO Model.
• The Shared Savings are earned during the term of the Participation Agreement, even if the actual distribution or use of the Shared Savings occurs after the expiration of that agreement.
• The Shared Savings are:
  • Distributed to or among ACO, its Participants, or individuals and entities that were its Next Generation Participants during the year in which the Shared Savings were earned, so long as the Next Generation Participants, or former Next Generation Participants, were not terminated under the Participation Agreement; or
  • Used by recipients of the Shared Savings, including Preferred Providers or other individuals or entities, for ACO Activities.
  • The Participation Agreement does not provide that this Shared Savings Distribution Waiver is inapplicable.

Note: The Shared Savings Distribution Waiver:

• Covers distribution of shared savings by ACO to participants, providers, and suppliers
• Does not cover the distribution of shared savings or incentives that commercial insurers pay. Commercial insurer payments may be protected under ACO participation waiver or existing Stark and anti-kickback exceptions

Compliance with the Physician Self-Referral Law (Stark) Waiver

Physician self-referral law (Stark) and Anti-Kickback Statute are waived concerning any financial relationship between or among the Next Generation ACO and its Next Generation Participants or Preferred Providers that implicates the physician self-referral law, provided that all of the following conditions are met:

• The ACO remains in good standing under the Participation Agreement.
• The financial relationship is reasonably related to ACO Activities
• The financial relationship fully complies with an exception at 42 CFR 411.355 through 411.357
• The Participation Agreement does not provide that this Compliance with the Physician Self-Referral Law Waiver is inapplicable

This waiver provides protection from anti-kickback statute enforcement for any arrangement that satisfies a Stark exception and precludes the need to comply with anti-kickback safe harbor.

Patient Engagement Incentives Waiver

Civil Monetary Penalties for beneficiary inducements and Anti-Kickback Statute are waived concerning items or services provided by the Next Generation ACO or its Next Generation Participants to Beneficiaries if all of the following conditions are met:

• The ACO remains in good standing under the Participation Agreement.
• There is a reasonable connection between the items or services and the medical care of the Beneficiary.
• The items or services are in-kind.
• The items or services:
• Are preventive care items or services; or
• Advance one or more of the following clinical goals:
  • Adherence to a treatment regime
  • Adherence to a drug regime
  • Adherence to a follow-up care plan
  • Management of a chronic disease or condition
• The Next Generation ACO maintains the records for each in-kind item or service provided as required by the Participation Agreement:
  • The nature of the in-kind item or service;
  • The identity of each Beneficiary that received the in-kind item or service;
  • The identity of the individual or entity that furnished the in-kind item or service; and
  • The date the in-kind item or service was furnished.
• The Participation Agreement does not provide that this Waiver for Patient Engagement Incentives is inapplicable.

AIPBP Payment Arrangement Waiver

Physician self-referral law (Stark) and Anti-Kickback Statute are waived concerning an AIPBP Payment Arrangement, provided that all of the following conditions are met:

• The ACO remains in good standing under the Participation Agreement.
• The ACO has entered into an AIPBP Payment Arrangement with the AIPBP-participating Next Generation Participant or Preferred Provider that establishes how the Next Generation ACO will make payments for Covered Services that are subject to the AIPBP Fee Reduction.
• In establishing the terms of, implementing, and performing under, the AIPBP Payment Arrangement, neither party gives or receives remuneration in return for or to induce business other than Covered Services covered by the AIPBP Payment Arrangement.
• The parties to an AIPBP Payment Arrangement must, upon request, provide the Government with access to records regarding the AIPBP Payment Arrangement (including records of any payments made or received under the arrangement) that are required to be maintained in accordance with Section XVIII.B of the Participation Agreement
• The Participation Agreement does not provide that this AIPBP Payment Arrangement Waiver is inapplicable.
• For arrangements that meet all the conditions mentioned above, the waiver period will start on the date of this Notice and end nine months after the expiration of the Participation Agreement. This includes any renewals, the effective date of termination of the Participation Agreement, and the date on which the AIPBP Payment Arrangement is terminated.

Remember, carefully review initiatives and waiver requirements, audit for continual compliance with waivers, and understand they do not apply to waive state anti-fraud regulations.

[1] The amended waivers for specified arrangements involving ACOs participating in the Next Generation ACO Model can be access at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/Amended-ACO-Model-Waivers.pdf.  Waivers for the Share Savings Model can be accessed at https://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27599.pdf.  Waivers for specified arrangements involving large dialysis organizations (LDOs) [PDF, 456KB]  participating in the CEC Model can be access at (https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/CEC-LDO-Model-Waivers.pdf ). Waivers for specified arrangements involving  small dialysis organizations (non-LDOs) [PDF, 461KB] participating in the CEC Model can be accessed at (https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/CEC-Non-LDO-Model-Waivers.pdf)