The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
One of the most common questions posed by parents of minor children who are separated – or who are about to separate – is the following: what is child support and how much can I expect to pay or receive in child support from...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more
On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
Efforts to draw attention to and, in some instances, dissuade private equity investment in healthcare have been on the rise. For example, in late 2023, the Centers for Medicare & Medicaid Services finalized a rule increasing...more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
As we previously reported, the Federal Trade Commission (FTC) recently announced its final changes to the Health Breach Notification Rule (HBNR), vastly expanding the scope of the Rule’s coverage....more
As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized a number of regulatory changes relating to how Medicare Advantage (MA) plans offer...more
In an informational bulletin, the Centers for Medicare & Medicaid Services (CMS) announced it will further extend waivers for “unwinding” under Section 1902(e)(14)(A) of the Social Security Act until June 30, 2025. The...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more
On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining...more
The Ninth Circuit Bankruptcy Appellate Panel held that the Social Security Administration’s withholding of post-petition benefits to satisfy the debtor’s prepetition obligation to repay overpayments qualifies as recoupment...more
On February 28, 2024, President Biden signed Executive Order (EO) 14117 titled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” On March 5,...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...more
On Tuesday, January 16, 2024, Governor Kathy Hochul released the SFY 2025 New York State Executive Budget (“Executive Budget”). While still subject to legislative approval, the Executive Budget incorporates the recently...more
On January 9, 2024, the Centers for Medicare & Medicaid Services (CMS) approved New York’s recent 1115 demonstration waiver. Among other things, this most recent demonstration waiver provides significant federal funding...more
On Friday, January 12, the Supreme Court of the United States granted certiorari in five cases: Smith v. Spizzirri, No. 22-1218: This case involves the interpretation of Section 3 of the Federal Arbitration Act (“FAA”),...more
The Centers for Medicare & Medicaid Services (“CMS”) released a final rule on November 15, 2023 (published on November 17, 2023) (the “Rule”), requiring greater skilled nursing facility (“SNF”) ownership transparency. The...more
Nursing facilities should prepare to provide the Centers for Medicare & Medicaid Services (CMS) with additional information about their ownership, their managing employees and the parties providing certain financial and...more
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
On October 11, 2023, CMS published a final rule (the Final Rule) regarding how and when CMS will impose civil monetary penalties (CMPs) for Medicare secondary payers (MSPs) that untimely report required information. The Final...more
On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more
On June 30, 2023, the United States District Court for the Eastern District of Texas (the Court) granted the State of Texas’ preliminary injunction motion, enjoining CMS from implementing and enforcing its Informational...more
On June 27, 2023, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a “Notice with Comment Period” (“Notice”) describing a new process for providing expedited Medicare coverage for certain eligible...more