Health Law Scan

Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as “waivers”) designed to offer flexibility to healthcare providers battling the virus. On April 11, the OCR announced that these waivers will officially expire on May 11, 2023, in conjunction with the end of the PHE. While it is not unexpected that the OCR is pulling back these waivers, healthcare providers must ensure that their ongoing operations are fully compliant with the OCR’s HIPAA-related requirements. This blog post details the list of waivers issued by the OCR that will expire on May 11.

COVID-19 significantly affected home-based care providers, such as home health agencies (HHAs) and hospices, whose staff had to overcome both physical and mental burdens of going into patients’ homes to deliver care, especially in the days before a COVID-19 vaccine. While these providers benefitted from a number of Medicare program regulatory flexibilities during the public health emergency (PHE), virtually all of those will sunset on May 11, 2023.

The Consolidated Appropriations Act of 2023 (CAA), the massive $1.7 billion spending bill signed into law on December 29, 2022, had a number of important healthcare “gems” included. A critical provision for substance use disorder treatment providers eliminated the X-Waiver and thereby enhanced providers’ ability to prescribe buprenorphine to Opioid Use Disorder (OUD) patients.

The US Department of Justice’s (DOJ’s) Civil Division released its annual fraud statistics on February 7, covering fiscal year 2022. Settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending on September 30, 2022. Consistent with previous years, a significant portion of the recoveries related to the healthcare industry.

The Antitrust Division of the US Department of Justice has withdrawn three longstanding enforcement policy statements regarding the exchange of competitively sensitive information in healthcare markets, e.g., through market benchmarking surveys. While the recission of the guidance does not itself change the law on competitors exchanging competitively sensitive information through intermediaries, our antitrust and competition team explains how the move signals potential increased federal scrutiny of that practice.

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.