On Friday, August 26, 2022, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”), the Department of Labor’s Employee Benefits Security Administration and the Department of Treasury’s Internal Revenue Service (the “Departments”) published a final rule updating key regulations pertaining to the No Surprises Act (the “Final Rule”). The Final Rule changes requirements promulgated through prior interim final rules[i] to conform with two rulings by the U.S. District Court for the Eastern District of Texas.[ii] The Final Rule addresses specific disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (“QPA”) for out-of-network (“OON”) services and sets forth the factors and information which certified Federal Independent Dispute Resolution (“IDR”) entities must consider in arbitrating disputes for OON services or items.

Continue Reading Final Rule Changes No Surprises Act Requirements

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.[1] EMTALA, which was enacted in 1986 to address concerns about patient dumping, went unnoticed for many years, but has garnered heightened attention as a result of the COVID-19 pandemic, and more recently, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (Dobbs).[2]

Continue Reading EMTALA in the Post-Dobbs World

In response to the COVID-19 Public Health Emergency (the “PHE”), the Centers for Medicare and Medicaid Services (“CMS”) issued numerous “blanket waivers” to increase access to medical services, and ease the regulatory burden on providers across the health care industry. In order to help providers understand the current status of the various waivers – some of which have been codified into law or adopted through the regulatory process, and others of which have already been terminated – CMS has issued a “Road Map” through a series of Fact Sheets for different provider types.

Continue Reading CMS Issues a “Roadmap” for the End of the COVID-19 Public Health Emergency and Blanket Waivers

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. Overall, the healthcare provisions of the IRA reflect the Administration’s goal of expanding the accessibility of healthcare to individuals by reducing costs to beneficiaries and capping charges by drug manufacturers. Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation.

Continue Reading Healthcare Reforms Under the IRA: Expanding Access to Care

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule[1] that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).

Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity

The Biden Administration has expressed a deep concern about nursing home owners and related parties excessively profiting off of the residents they serve to the detriment of quality care. To address this concern, President Biden has asked Congress to implement laws that will empower federal agencies such as the Centers for Medicare and Medicaid Services (CMS) to increase accountability for facility ownership and expand enforcement authority at the ownership level. In addition, the federal agencies that regulate and oversee nursing homes (and some states[1]) have or plan to take action to ensure more transparency, compliance and enforcement regarding nursing facility ownership. Indeed, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) announced last week that it will undertake an audit of skilled nursing facility Medicare payments to related parties. Facility owners and operators should heed these developments, which as discussed below, focus on several fronts, and ensure that their relationships and operations are in accord with existing federal and state related party laws and regulations.

Continue Reading Nursing Homes Beware: the Government has Increased Its Scrutiny of Related Parties

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.

Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to existing, low-income patients (the “Arrangement”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”)[1] and was not likely to generate remuneration prohibited under the federal Civil Monetary Penalties Law prohibiting inducements to health care program beneficiaries (“Beneficiary Inducement CMP”)[2].

Continue Reading OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program

On August 5, President Biden signed two bills into law that extend to ten years the statute of limitations for civil and criminal enforcement actions for fraud on the Paycheck Protection Program (“PPP”) and Economic Injury Disaster Loans (“EIDL”). These two bills—the PPP and Bank Fraud Enforcement Harmonization Act of 2022 and the COVID-19 EIDL Fraud Statute of Limitations Act of 2022—were both passed by Congress with bipartisan support. 

Continue Reading Statute of Limitations for PPP and EIDL Fraud Extended to Ten Years

The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems. The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face FCA liability for suggesting providers use their devices in any way the FDA has not approved (and in this case, warned against).

Continue Reading The Government Seeks FCA Liability for Off-Label Use of Medical Devices

The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of the Federal health care program anti-kickback statute (“AKS”). According to the appellate court, the trial court’s jury instruction “brushed aside causation” and “misinterpreted” a 2010 amendment to the AKS.

Continue Reading Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the Items and Services Subject to the Claim