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
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As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances
By Conor Duffy
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…
New York Proposes Regulatory Overhaul for HealthCare Transactions with a Focus on Investor-Backed Healthcare Transactions
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…
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…
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…
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…
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act
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…
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”…
Timing is Everything: The Antitrust Division and OIG Sign Cross-Agency Agreement as Government Investigations Are Expected to Surge
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…
Key Changes to the Medicare Shared Savings Program
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…