Yesterday, the OIG released a Special Fraud Alert related to: (1) marketing arrangements between Medicare Advantage Organizations (“MAOs”) and health care professionals (“HCPs”), and (2) arrangements between HCPs and MA plan agents and brokers. In the Alert, OIG states that these types of arrangements may implicate the Federal anti-kickback statute (the “AKS”) and could result in unfair competition and improper steering of Medicare beneficiaries. Despite flagging these concerns, the Alert fails to offer specific, practical guidance on the types of arrangements that would or would not violate the law, and therefore does little to alleviate industry-wide confusion as to how to compliantly engage in beneficiary outreach and support.Continue Reading Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers
Office of the Inspector General ("OIG")
EMTALA: In the Spotlight
Almost 40 years after its passing, the Emergency Medical Treatment and Active Labor Act (EMTALA) remains not only a key consideration for hospitals with emergency departments, but also a significant federal enforcement priority. EMTALA requires hospitals with emergency departments that participate in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, stabilizing treatment and transfer for patients with emergency medical conditions (EMCs) and women in labor.Continue Reading EMTALA: In the Spotlight
Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space
Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space
OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance
“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance
District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute
New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses
On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to physician practices in exchange for referring the Requestor’s practice optimization services (e.g., workflow and performance assessment, data analytics, and certain Medicare eligibility and performance assistance). Among other things, the Requestor: (i) did not itself provide any services that were eligible for reimbursement under any Federal healthcare program to any of its clients, (ii) did not have an ownership or investment interest in any entity that provided items or services paid for by any Federal healthcare program, and (iii) received compensation from the physician practices that did not vary based on whether the physician practices received a greater or lesser reimbursement from Medicare based on the Requestor’s services. The Opinion concluded that this proposed arrangement would not generate prohibited remuneration under Section 1128B(b) of the Social Security Act (the “Act”), also known as the Federal Anti-Kickback Statute (“Anti-Kickback Statute”), and thus OIG would not impose administrative sanctions under Section 1128A(a)(7) (exclusion) or Section 1128(b)(7) (civil monetary penalty) of the Act on the Requestor. As always, the Opinion stipulated that it may only be relied on by the Requestor on the specific facts presented to OIG, and that certain state and federal laws may continue to limit similar arrangements. However, the Opinion indicates that the tight scope of potential marketing options for physician practice vendors could expand a bit for those who are similarly situated to the Requestor.Continue Reading New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses
OIG General Compliance Program Guidance November 2023
In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].Continue Reading OIG General Compliance Program Guidance November 2023
OIG Confirms the Broad Protection of Employee Safe Harbor
Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the bona fide employee exception and safe harbor to the federal Anti-Kickback Statute (the “AKS”). The opinion highlights flexibility for healthcare providers seeking to compensate employees in ways that align incentives with their employers, and particularly for physician practices to align employed physicians with use of the practices’ ambulatory surgery center (“ASC”) capabilities.Continue Reading OIG Confirms the Broad Protection of Employee Safe Harbor
New York Medicaid Providers Now Have Two Pathways to Self-Disclose Overpayments to the Office of the Medicaid Inspector General
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) announced updates to the Medicaid overpayment self-disclosure program, which now includes an abbreviated process for reporting and explaining overpayments that are considered routine or transactional in nature and have been already voided and adjusted.Continue Reading New York Medicaid Providers Now Have Two Pathways to Self-Disclose Overpayments to the Office of the Medicaid Inspector General
HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule
Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking enforcement rules since the Office of the National Coordinator for Health Information Technology (ONC) issued its final information blocking rules in 2020.[i] Continue Reading HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule
OIG’s Modernization of Compliance Program Guidance: What to Expect
The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG). Historically, sector-specific CPG has been published in the Federal Register. Going forward, the OIG will publish all current and updated CPG on its website.Continue Reading OIG’s Modernization of Compliance Program Guidance: What to Expect