The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.

Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:

Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic.  The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination (Tele-Prescribing Rule), and (2) expansion of buprenorphine prescribing via telemedicine encounters (Buprenorphine Rule).  Below please find a high-level summary of the Tele-Prescribing Rule.  A separate post will follow addressing the Buprenorphine Rule in detail.

Continue Reading As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

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. 

Continue Reading New York Proposes Regulatory Overhaul for HealthCare Transactions with a Focus on Investor-Backed Healthcare Transactions

HIPAA requires that covered entities notify the Office for Civil Rights (OCR) of any breaches of unsecured protected health information that affects less than 500 individuals in a calendar year within 60 days following the end of the calendar year.

Therefore, all breaches that affected less than 500 individuals that occurred in 2022 and have not already been reported to the OCR must be reported no later than March 1, 2023.

These breaches can be reported to the OCR through its online portal:  https://ocrportal.hhs.gov/ocr/breach/wizard_breach.jsf

This post is also being shared on our Data Privacy + Cybersecurity Insider blog. If you’re interested in getting updates on developments affecting data privacy and security, we invite you to subscribe to the blog.

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