On April 14, 2023, the Attorneys General of 18 different states sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure in support of a proposed rule that would require the disclosure of certain ownership information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (collectively “Nursing Facilities”), particularly from private equity investors and real estate investment trusts (the “Proposed Rule”).
Medicare
Stark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a regional hospital system (Hospital) and two individual physicians, respectively.…
CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
By Conor Duffy, Erin Howard & Guest Contributor on
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.
Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:…
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act
By Conor Duffy & Leslie Levinson on
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the current standard under the “60-Day Rule” for identifying a Medicare overpayment. Specifically, CMS indicated that it is proposing to (i) “adopt by reference” the federal False Claims Act’s (FCA) definitions of “knowing” and “knowingly” as governing when an overpayment is identified, and (ii) eliminate the “reasonable diligence” standard that has been in place, but subject to challenges, for a number of years.…
Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate officers, resolving alleged violations of the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly referred to as the “Stark Law”). One case settled claims that Carter had made improper payments to referring physicians in Oklahoma and Texas, while the other case settled claims that Carter had made false billing claims in Florida. Both matters were initiated by qui tam whistleblower complaints filed under the FCA. Carter agreed to pay more than $30 million to resolve the allegations.…
340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals” and therefore, that HHS exceeded its statutory authority by varying the 2018 and 2019 rates for 340B hospitals without first conducting such survey.…
OIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic
The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by Medicare during the first year of the COVID-19 pandemic (the Pandemic).[1] The OIG analyzed Medicare and Medicare Advantage claims data from March 1, 2020, to February 28, 2021, focusing on providers that billed for telehealth services, with an emphasis on identifying providers that posed a high risk to the Medicare program.…
Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The case, which was brought by the American Hospital Association, arises from reimbursement reductions imposed by the Department of Health and Human Services (HHS) in 2018 and 2019 on hospitals participating in the 340B program (which the Court noted are hospitals that “generally serve low-income or rural communities”). In those years, HHS sought to impose reductions in reimbursement due to favorable pricing available to 340B hospitals under that program. The hospitals challenged those reductions based on the process HHS followed when setting the reimbursement rates, claiming that HHS’s failure to conduct a survey of hospitals’ average acquisition costs for the drugs prevented HHS from varying reimbursement rates for this distinct group. Therefore, according to the hospitals, HHS was required to pay them based on the average sales price charged by manufacturers for the drugs.…
Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services
On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement involving the loaning of smartphones to patients to allow those patients to receive telehealth services from the Requestor. The OIG concluded that although the arrangement would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the limited scope of the arrangement and the safeguards in place did not warrant the imposition of sanctions.
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OIG Creates New Telehealth Resources Webpage
The Office of Inspector General (OIG) recently created a new webpage related to telehealth. The purpose of the webpage is to summarize the OIG’s telehealth oversight work to provide a summary of its findings and recommendations that can be used by policymakers and other stakeholders to evaluate potential changes to federal telehealth policies.
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