Medicare Compliance & Reimbursement

Hint: Expect safe harbors that promote value and coordination.

Many of the federal rollbacks over the past year have been initiated to reduce providers’ burdens. Now, the feds have turned the spotlight on fraud and abuse regulations, offering better safeguards to encourage care coordination with pro-patient policies.

Context: The HHS Office of Inspector General (OIG) announced a bevy of changes in tandem with the Centers for Medicare & Medicaid Services (CMS) Stark update in its own proposed rule. OIG’s proposed rulemaking aligns with HHS Regulatory Sprint to Coordinated Care policies and impacts Civil Monetary Penalties (CMPs) and the Anti-Kickback Statute (AKS). The proposal was published in the Federal Register on Oct. 17.

Reminder: AKS “applies to any financial arrangement that impacts federal health care program beneficiaries, e.g., TriCare and other programs in addition to Medicare and Medicaid,” says attorney Linda Baumann, partner with Arent Fox in Washington, D.C.

Reasoning: Currently, AKS regulations and the use of CMPs inhibit “beneficial arrangements” and thwart “value-based care” in “both federal healthcare programs and the commercial sector,” according to the OIG fact sheet on the proposed rule. Several new safe harbors are on the table to improve patient engagement, interoperability, and provider coordination.

Read on to see what OIG recommends to circumvent fraud and abuse:

• Three safe harbors, which vary based on the level of financial risk and care coordination, are proposed for “certain remuneration exchanged between or among eligible participants in a value-based arrangement,” suggests the fact sheet.
• A safe harbor is suggested to bump up patient engagement that aligns with the feds’ quality objectives.
• A CMS payment model safe harbor aims to revise compensation policies and cut down on the need for fraud and abuse waivers. There is also a proposal to improve the Accountable Care Organization Beneficiary Incentive programs through the Medicare Shared Savings Program.
• A cybersecurity safe harbor is proposed; plus, modifications are recommended for current EHR safe harbors to better align with health IT updates.
• New “modifications” are introduced to add to “the existing safe harbor for personal services and management contracts” for “flexibility with respect to outcomes-based payments and part-time arrangements,” the fact sheet indicates.
• Warranties are in the proposal with a safe harbor makeover that includes a revised definition and safeguards for bundled services.
• Transportation safe harbors for discharges and rural areas are proposed.
• A CMP exception is suggested for telehealth services for in-home dialysis.

The deadline to send your comments to OIG is Dec. 3.

Review the proposed rule at www.federalregister.gov/documents/2019/10/17/2019-22027/medicare-and-state-healthcare-programs-fraud-and-abuse-revisions-to-safe-harbors-under-the.