Legal Insights and Perspectives for the Healthcare Industry
Pressure continues to mount on the US Department of Health and Human Services (HHS) to reconsider and revise its August 2022 final rule modifying the No Surprises Act independent dispute resolution (IDR) process. The rule is an attempt to revise the original IDR process, which “placed its thumb on the scale” for payors, according to the February 2022 federal district court decision in Texas Medical Association v. US Department of Health and Human Services.
Another year has come to pass, and it seems the federal Public Health Emergency (PHE) will remain in place for at least the next five months. Why? As the US Department of Health and Human Services (HHS) has continuously pledged throughout the COVID-19 pandemic, the federal government intends to give states and healthcare providers at least a 60-day notice before terminating the PHE, which has granted significant flexibilities for furnishing healthcare services covered by Medicare, including in the context of telehealth. That 60-day notice period for the current PHE expiration date came and went on November 12 with no word from Secretary Xavier Becerra that the federal government would seek to wind down PHE flexibilities at the start of 2023. As a result, the PHE in all likelihood will be extended for an additional 90 days in early January 2023, for a revised expiration date of April 11, 2023.
The HHS Office of Inspector General (OIG) has, for the last several years, been actively auditing hospices regarding their Medicare regulatory and billing compliance, with a national hospice audit in the works. Recently, OIG has notified certain hospices that it is conducting an audit of hospices’ compliance with CARES Act Provider Relief Fund (PRF) requirements and whether the hospices complied with certain terms and conditions and federal requirements related to the use of those PRF grants that were furnished to Medicare providers as part of the COVID-19 relief efforts in 2020 and 2021.
The Centers for Medicare & Medicaid Services (CMS) delayed the publication of the final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs). The proposed rule was published on November 1, 2018, more than four years ago. With this latest extension, the final rule deadline is now February 1, 2023.
On October 3, the Office of Inspector General (OIG) of the US Department of Health and Human Services issued a report titled “UPICs Hold Promise to Enhance Program Integrity Across Medicare and Medicaid, But Challenges Remain.” This report detailed OIG’s findings related to the efficacy of the Unified Program Integrity Contractor (UPIC) program.
Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.
The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have likewise increased fraud enforcement in this area, including through the issuance of OIG’s recent Special Fraud Alert (SFA).
The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely that the PHE will be extended for at least another 90 days. Previously, the federal government had pledged to states that it would announce an end to the PHE at least 60 days before its expiration. That 60-day time frame ended on May 16 with no indication from the US Department of Health and Human Services (HHS) that it was anticipating the end of the PHE.
Federal antitrust enforcers at the US Department of Justice (DOJ) and Federal Trade Commission (FTC) continue to take an aggressive stance in healthcare. Two recent developments underscore the trend. 
Fraud stemming from the COVID-19 pandemic continues to be a criminal enforcement priority for the US Department of Justice (DOJ). On April 20, DOJ announced a new round of criminal charges against 21 defendants that stem from over $149 million in allegedly fraudulent billing to federal healthcare programs and pandemic assistance programs. The new cases raise DOJ’s total COVID-19-related enforcement stats to 35 defendants and over $290 million in fraudulent billing across 16 federal districts.