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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:…

Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic.  The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination (Tele-Prescribing Rule), and (2) expansion of buprenorphine prescribing via telemedicine encounters (Buprenorphine Rule).  Below please find a high-level summary of the Tele-Prescribing Rule.  A separate post will follow addressing the Buprenorphine Rule in detail.…

Continue Reading As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

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.…

Continue Reading No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued changes to the Medicare Shared Savings Program to advance CMS’ broader strategy of growth, alignment, and equity. To improve the overall operations of the Shared Savings Program, CMS is finalizing changes that, among other things, will impact payment and Accountable Care Organization (ACO) beneficiary assignment, update quality reporting and performance requirements, and reduce the administrative burden for ACOs.…

Continue Reading Key Changes to the Medicare Shared Savings Program

On November 4, 2022, the Centers for Medicare & Medicaid Services (CMS) published the calendar year 2023 Home Health Prospective Payment System Rate final rule, which updates Medicare payment policies and rates for home health agencies.  Some of the key changes implemented by the final rule are summarized below.…

Continue Reading CMS Issues Calendar Year 2023 Home Health Final Rule

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule (PFS). These final rules implement various updates and policy changes for Medicare payments under the PFS and OPPS, and made significant updates to the Medicare Shared Savings Program (MSSP), which go into effect on or after January 1, 2023. We summarize the key changes below and will elaborate on these rules in future posts.…

Continue Reading CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule

On October 17, 2022, the United States Department of Justice (DOJ) announced a $13 million settlement with health care services provider Sutter Health, which arose from alleged violations of the federal False Claims Act (FCA).  These alleged FCA violations relate to Sutter Health billing the United States for toxicology screening tests performed by other labs.…

Continue Reading DOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests

On October 17, 2022, the Supreme Court denied certiorari in three cases asking the court to resolve a circuit split regarding the application of the particularity pleading requirement for allegations of fraud in False Claims Act (FCA) cases, as required under Federal Rule of Civil Procedure 9(b). The cases are: Johnson, et al. v. Bethany Hospice, 21-462; U.S., ex rel. Owsley v. Fazzi Associates, Inc., et al., 21-936; and Molina Healthcare, et al. v. Prose, 21-1145. Molina also presented a second question over which circuits had split, regarding the correct interpretation of Universal Health Services, Inc. v. United States ex rel. Escobar and whether a request for payment without specific representations can be actionable under an implied false certification theory. (Petition for Writ of Certiorari).…

Continue Reading Supreme Court Denies Certiorari in Three FCA “Particularity” Cases

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.…

Continue Reading Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the imposition of sanctions under the federal anti-kickback statute (AKS). The OIG concluded that while beneficiary access to potentially life-saving medications is essential, the provisions of the proposed arrangement “would present more than a minimal risk of fraud and abuse” under the AKS.…

Continue Reading Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions