Proposed legislation from the New York State Executive Budget for 2024 includes significant changes to the state’s regulatory approach and authority over healthcare transactions. New York is following a trend on the state level regarding concern over the consolidation of the healthcare marketplace and investor-backed practices and how such transactions should be reviewed. Such proposal follows states like California, Oregon, and Washington. The proposal creates a new statutory article to review “material transactions” and has made changes to the certificate of need process for new and existing entities.
California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities Statewide
On June 30, 2022, Governor Gavin Newsom signed the 2022-2023 California state budget, which included a trailer bill, Senate Bill 184 (the Bill) which makes numerous statutory revisions impacting health programs and consumers. The Bill establishes the Office of Health Care Affordability (OHCA) within the Department of Health Care Access and Information to combat rising health care costs. California will join other states such as Massachusetts, Oregon, and Nevada in implementing a health care cost commission.
California Governor Signs Bill Further Increasing Oversight of Hospice Agencies
This fall, California Governor Gavin Newsom signed Assembly Bill No. 2673 (the Bill), which amends various sections of the California Health and Safety Code relating to hospice agencies. Among other things, the Bill prohibits hospice agency license transfers; adds requirements for hospice agency license applicants; increases oversight authority by the California State Department of Public Health (the Department); and updates the moratorium on new hospice agency licenses.
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New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices
On December 23, 2022, New York Governor Kathy Hochul vetoed Assembly Bill Number 8472 entitled “An Act To Amend The Public Health Law, In Relation To The Establishment, Incorporation, Construction, Or Increase In Capacity Of For-Profit Hospice” (the Act). The Act was intended to prohibit the approval, incorporation, or construction of for-profit hospices and would have also prevented any existing for-profit hospices from increasing capacity. The Act would have gone into effect immediately had it not been vetoed.
OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests
As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023. On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a Report entitled, “Labs With Questionably High Billing for Additional Tests Alongside COVID-19 Tests Warrant Further Scrutiny” (Report). The Report discusses why the study pertaining to the billing of additional tests alongside COVID-19 testing was conducted, how it was conducted, and what the key takeaways of the study are. This was followed by OIG’s issuance in mid-December of a Data Brief reviewing Medicare Part B spending on lab tests entitled, “Medicare Part B Spending on Lab Tests Increased in 2021, Driven by Higher Volume of COVID-19 Tests, Genetic Tests and Chemistry Tests” (Data Brief).
HHS Proposes Rule to Align Part 2 Records and HIPAA
On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from the date of publication.
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DOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests
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.
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Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic
On September 6, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-17 (Advisory Opinion), in which it declined to impose sanctions against a regional 501(c)(3) not-for-profit health care system that operates four hospitals (Health System) and a clinic that provide services to geographic areas that have been designated as medically-underserved areas and health professional shortage areas (together, the Requestors). The Health System had supported the establishment of the clinic, which is registered as a Free Clinic and been designated as a Federally Qualified Health Center (FQHC) Look-Alike (Clinic), (but is neither a FQHC nor does it receive funds under Section 330 of the Public Health Service Act). The arrangement involves the forgiveness of a credit line note entered into by the Health System with the Clinic. The OIG concluded that although the arrangement would constitute prohibited remuneration under the federal anti-kickback statute (AKS) if the requisite intent were present, the arrangement and the safeguards in place did not warrant the imposition of sanctions.
Supreme Court Denies Certiorari in Three FCA “Particularity” Cases
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).
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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.