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McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
We are in the midst of a storm of regulations that are being released by the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services (HHS), including the Calendar Year (CY) 2025...more
The U.S. Department of Health and Human Services (HHS) has issued a proposed rule entitled “Nondiscrimination in Health Programs and Activities.” The proposed rule, designed to advance health equity and protect people from...more
Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...more
Medicaid Regs Part 2! Last week, Regs & Eggs took a deep dive into the Ensuring Access to Medicaid Services final reg, one of two regs that the Centers for Medicare & Medicaid Services (CMS) released to add new requirements...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more
The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory, episode-based alternative payment model in the Fiscal Year 2025 Hospital Inpatient...more
Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more
On February 21, Superintendent Adrienne A. Harris of the New York State Department of Financial Services (DFS) unveiled a proposed regulation, 11 NYCRR 38. If adopted, this regulation, would establish network adequacy...more
The public comments are in! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) are now reviewing the 136 comments they received on a proposed...more
Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more
Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more
Hungry for some Regs & Eggs? Well, you are in luck, because this week, the Regs & Eggs buffet is open, with your choice of eggs made any style. Enough regs were released this week to feed an entire family—and the...more
Time’s up and pencils down! Comments on the calendar year (CY) 2024 physician fee schedule (PFS) proposed reg were due earlier this week. Now, the Centers for Medicare & Medicaid Services (CMS) will have to review them and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
In the 118th Congress, the US House of Representatives is keenly interested in price transparency in healthcare. Three House committees—Energy and Commerce, Ways and Means and Education and the Workforce—each approved...more
On July 10, 2023, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) that would (i) include hospices in the 36-month rule ownership transfer restrictions that currently exist for home...more
Last week, the Centers for Medicare & Medicaid Services (CMS) released the two major regulations we all were waiting for: the Calendar Year (CY) 2024 Physician Fee Schedule (PFS) proposed reg and the CY 2024 Outpatient...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more
During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...more