Consistent with the Biden Administration’s whole-of-government approach to address perceived consolidation in a variety of industries, including in the healthcare industry, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) Antitrust Division (collectively, the Agencies) are continuing to make good on their promise to increase scrutiny of mergers and acquisitions through newly proposed HSR rules and revised merger guidelines.
The Department of Health and Human Services (HHS) through its Office of Inspector General (OIG), announced plans for significant updates and modernization of OIG compliance program guidance (CPG) to improve their accessibility and usability for healthcare entities.[1] Originally issued in 1998, the CPG provide healthcare organizations across the industry with guidance on developing, implementing, and maintaining internal compliance controls. In the 25 years since, the OIG has issued multiple and specific CPGs that apply to particular segments of the healthcare industry including Medicare Advantage organizations, hospitals, home health agencies, nursing homes, and clinical laboratories. However, over time the CPGs have not sufficiently kept up with the innovations and growth of the healthcare industry.
Since last year, the Husch Blackwell privacy attorneys have been working with various healthcare providers—from hospitals to hospices, to independent physician groups—to comply with the Information Blocking rule (the Rule) implemented by the Office of the National Coordinator for Health Information Technology (ONC) as part of the 21st Century Cures Act. Recently, Education clients have been asking, “We’re a university – does the Information Blocking rule apply to our student health center?” We discuss the answer to that question, along with practice tips, in this blog post.
On February 25, 2021, the Wisconsin Legislature enacted 2021 Wisconsin Act 4 (the “Act”), which, in part, grants immunity to business entities from civil liability related to COVID-19 exposure, with certain exceptions.
Specifically, the Act immunizes certain entities from civil liability for any act or omission in the course of performance or provision of the entity’s function or services, that leads to death or injury to an individual or damages caused by an act or omission resulting from or relating to exposure directly or indirectly to COVID-19 (or its variants), or conditions associated with the infectious disease. However, civil immunity does not extend to acts or omissions that are reckless, wanton conduct, or intentional misconduct.
On December 10, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a proposed rule that would revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
In its news release, OCR noted that the changes “seeks to promote value-based health care by examining federal regulations that impede efforts among healthcare providers and health plans to better coordinate care for patients.” The proposed changes come on the heels of the recently delayed Information Blocking Rule, which seeks to prohibit interferences with access, exchange, or use of electronic health information (EHI). The key proposed changes are discussed below.
With all that 2020 has brought, the Information Blocking Rule that came out of the Cures Act was under the radar of many hospices. Thankfully, HHS extended the compliance date for the Rule to April 5, 2021, from November 2, 2020. With this additional time, hospices need to evaluate how they will achieve compliance; what
On May 1, 2020, the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology (ONC) released its final rule (Final Rule) on “Information Blocking” as part of the 21st Century Cures Act. The Final Rule applies to the following (ONC refers to each one as an “Actor”): (i) healthcare providers, (ii) health IT developers subject to ONC’s Health IT Certification Program, (iii) health information networks (HIN) or (iv) health information exchanges (HIE). With the initial enforcement date fast approaching (November 2), we explain the rule below.
In July of 2016, through 2013 Wisconsin Act 236 (Act 236), many of the regulatory provisions of Wis. Admin. Code DHS 124, Wisconsin’s long-standing hospital regulations, were sunset and replaced with the Medicare Conditions of Participation for hospitals (CoPs) as the minimum standards, enforceable by the Department of Health Services (the Department). However, the administrative provisions detailing the approval and plan review processes, fees, waivers and variances, requirements relating to Critical Access Hospitals (CAHs) were retained. Moreover, the Department retained the ability to promulgate additional rules, if necessary,Th to provide safe and adequate care and treatment of hospital patients and to protect the health and safety of the patients and employees.
Although Wisconsin hospitals have remained busy providing COVID-related treatment and services for the last two months, many Wisconsin health care providers chose to postpone elective surgeries and procedures in compliance with CMS guidance. Notably, Wisconsin never expressly prohibited elective surgeries or procedures at any point during the last few months; however, Emergency Orders #12 and #28 specified that individuals may obtain services at ambulatory surgery centers for response to urgent health issues or related COVID-19 activities. Further, guidance from the Wisconsin DHS Division of Public Health issued on March 20 recommended that dental practices postpone all elective and non-urgent care treatment. With the issuance of the Badger Bounce Back Plan (the “BBB Plan”), Wisconsin facilities and providers have expressed their intent to prep for elective services and procedures.
In a Policy Statement released on April 3, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced that it will exercise its enforcement discretion and not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for certain financial arrangements related to COVID-19 covered by the blanket waivers issued by the Secretary of HHS on March 30, 2020 (the Blanket Waivers). The Blanket Waivers apply to sanctions for potential violations of the federal Physician Self-Referral Law (also known as the Stark Law) with respect to specific “COVID-19 Purposes,” which Husch Blackwell summarized in a recent blog. The OIG’s Policy became effective upon release (while the Blanket Waivers are retroactively effective March 1, 2020), and will terminate upon termination of the Blanket Waivers, unless otherwise specified by the OIG.