Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the manufacturer’s cochlear implant devices (Proposed Arrangement). In reaching its determination, the OIG reiterated its longstanding concern about free items or services to Medicare and Medicaid beneficiaries because such arrangements could result in steering and unfair competition. Of note, the free hearing aids under the Proposed Arrangement have a retail value of $1,180 to $2,240 which far exceeds the $570 limit imposed under the only potentially relevant safe harbor – the patient engagement and support safe harbor.

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider of intraoperative neuromonitoring (IONM) services. In reaching its determination, the OIG stated that Newco and its arrangements with the IONM Company would present a significant risk under the federal Anti-Kickback Statute (AKS) primarily because it exhibits many indicia of a suspect contractual joint venture.

The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate independently in value-based care initiatives. The MCP Model will be tested in eight states - Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, New York, North Carolina, and Washington.

Health care providers furnishing dementia care should take note of a new payment model announced by the Centers for Medicare & Medicaid Services on July 31, 2023, called Guiding an Improved Dementia Experience (GUIDE). GUIDE is designed to improve dementia care, reduce strain on unpaid caregivers, and help people with dementia remain in their homes and communities. Providers participating in GUIDE receive monthly per-beneficiary per-month payments, can bill for respite care services, and are eligible for one-time payments to support infrastructure.

The Department of Health and Human Services’ Office of Inspector General (OIG) announced on April 24, 2023 that it will soon issue long overdue updates to its compliance program guidance documents (CPGs).  First introduced in 1998, the CPGs are a series of voluntary guidance documents, each tailored to a specific segment of the health care industry. While the CPGs include important insights on specific risk areas and how to apply the seven elements of an effective compliance program to particular types of health care entities, they are ripe for modernizing. OIG will publish a General CPG (GCPG) applicable to all individuals and entities involved in the health care industry by the end of 2023, followed by industry-specific CPGs (ICPGs) in 2024. Of note, the OIG announced that its first two ICPGs will address Medicare Advantage and Skilled Nursing Facilities (SNFs), perhaps signaling the OIG’s priorities. The OIG’s updates to the CPGs are part of the OIG’s Modernization Initiative first announced in September 2022.

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or preventive care services. The proposed arrangement involves an in-home colorectal cancer screening company’s proposal to provide gift cards of up to $75 to encourage patients to return their samples for their colorectal cancer screening. Though the OIG noted that the gift cards implicate the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements CMP because they would influence patients to receive reimbursable services from the requestor, the OIG concluded that the arrangement presented a minimal level of risk.  

The Stark Law’s Self-Referral Disclosure Protocol (SRDP) will include a new Group Practice Information Form for physician practices to report any noncompliance arising from not fully satisfying the Stark Law’s definition for a “group practice,” effective March 1, 2023. The Centers for Medicare & Medicaid Services (CMS) intends for the changes to reduce regulatory burden and streamline the disclosure process.

As Accountable Care Organizations (ACOs) and providers gear up for the start of the new ACO REACH Model in 2023, CMS recently issued helpful policy updates to the model’s benefit enhancements (BEs). Under BEs, CMS waives certain Medicare payment requirements for services provided to REACH beneficiaries through the REACH ACO’s participant providers and preferred providers. REACH ACOs can opt to use one or more of the BEs, which are designed to create flexibility in managing REACH beneficiaries’ care. REACH ACOs have full control over which providers participate in any BE. As discussed below, CMS recently announced updates to two of the model’s BEs – the 3-Day Skilled Nursing Facility (SNF) Rule Waiver and the Nurse Practitioner (NP) Services.   

The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in accountable care arrangements.  The changes are included in the Calendar Year 2023 Physician Fee Schedule final rule (Final Rule), which is scheduled for publication on November 18, 2022.

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase patients’ awareness of the Open Payments database so they can make informed decisions about drugs and devices prescribed by their physician. This blog post provides an overview of the Open Payments Program, what exactly California's AB 1278 entails, and the implications of the law come January 2023 and January 2024.