On January 19, 2021, the final rule revisions to safe harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules regarding beneficiary inducements went into effect. The final rule was issued by the Office of Inspector General (OIG), in partnership with the Centers for Medicare & Medicaid Services (CMS). The goal of the final rule is to protect certain value-based arrangements that would improve quality, outcomes, and efficiencies. The OIG also suggests that the increased flexibilities may assist stakeholders in responding to and recovering from the pandemic, as well as facilitate the development of sustainable value-based care delivery models for the future.
Some of the key changes of the final rule include:
- New Value-Based Safe Harbors: The Anti-Kickback Statute final rule establishes three new safe harbors for reimbursement between or among participants in a value-based arrangement that encourages better coordinated and managed patient care. The value-based safe harbors apply to—
- Care Coordination Arrangements
- Value-Based Arrangements with Substantial Downside Financial Risk
- Value-Based Arrangements with Full Financial Risk.
- Patient Engagement and Support Safe Harbor is intended to reduce the need for the OIG to issue separate fraud and abuse waivers for new CMS-sponsored healthcare delivery models.
- Cybersecurity Technology and Services Safe Harbor protects reimbursement in the form of non-monetary donations of certain cybersecurity technology and services to facilitate improved cybersecurity in healthcare and to guard against security threats,
- Medicare Shared Savings Accountable Care Organization’s (ACO) Beneficiary Incentives classifies the statutory exception of reimbursement related to incentive payments to assigned Medicare beneficiaries under ACO beneficiary incentives.
The Federal Anti-Kickback Statute is an intent-based, criminal statute that prohibits intentional payments, whether monetary or in-kind, in exchange for referrals or other Federal healthcare program business. Safe harbor regulations describe various payment and business practices that, although they potentially implicate the Federal Anti-Kickback Statute, are not treated as offenses under the Statute. Compliance with a safe harbor is voluntary. The Beneficiary Inducements Civil Monetary Penalty is a civil, administrative statute that prohibits knowingly offering something of value to a Medicare or State healthcare program beneficiary to induce them to select a particular provider, practitioner, or supplier.
The final rule can be accessed at Federal Register :: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements.
Issue:
It is critical that all members of the healthcare team understand the Anti-kickback Statute, including that if the Statute is violated, everyone involved may be prosecuted. This can include doctors, nurses, medical suppliers, or anyone else that may have benefited from the kickback. Violators of the Statute can be prosecuted in federal court and can face significant fines and prison time.
Discussion:
- Review policies and procedures relating to the Anti-Kickback Statute. Update policies to include the new revisions to the final rule.
- Train all appropriate staff on the Anti-Kickback Statute and the new final rule revisions. Ensure that staff understand that reporting their observations or concerns about potential or actual violations and use of kickbacks is mandatory, and that they can call the anonymous hotline if not comfortable reporting internally. Repeat training annually, or more often if needed.
- Periodically audit to ensure that there are no violations of the Anti-Kickback Statute within your facility. Obtain additional information about prevention and identification of kickbacks by reviewing the Med-Net Corporate Compliance and Ethics Manual, Chapter 1: Compliance and Ethics Program, and Chapter 3: Vendor and Associate Contracts and Services.
FRAUD MODULE 3 – MASTERING LEGAL IMPLICATIONS AND ANTITRUST LAWS
