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.

Continue Reading California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities Statewide

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.

Continue Reading California Governor Signs Bill Further Increasing Oversight of Hospice Agencies

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.

Continue Reading New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices

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

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). 

Continue Reading OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests

On December 9, 2022, the U.S. Department of Justice, Antitrust Division and the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) (collectively, the Agencies) formalized their long-standing partnership to fight anti-competitive conduct in healthcare markets by signing a memorandum of understanding (the MOU) to enhance cross-agency collaboration.  Although the Agencies have conducted parallel investigations in the past, the timing of the MOU indicates that health care industries will receive increased scrutiny from both in 2023.  Companies can proactively mitigate this risk with thorough compliance training that explains what constitutes misconduct and the grave civil and criminal penalties that can ensue.    

Continue Reading Timing is Everything:  The Antitrust Division and OIG Sign Cross-Agency Agreement as Government Investigations Are Expected to Surge

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 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.

Continue Reading HHS Proposes Rule to Align Part 2 Records and HIPAA

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