This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.

On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical practices in North Carolina

On March 12, 2024, the U.S. Court of Appeals for the Second Circuit issued an important decision interpreting the “willfulness” standard necessary to find a violation of the federal Anti-Kickback Statute (AKS). The decision provides important guidance for health care and pharmaceutical organizations on what constitutes a knowing violation of the AKS and for counsel

Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.

The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”),[1] has experienced significant legal challenges

On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42

On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking

On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07 (Advisory Opinion), in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the physicians at ambulatory surgery centers.Continue Reading OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits

On Monday, October 2, 2023, the New York Office of the Medicaid Inspector General (OMIG) published its Annual Report for 2022. The Report details the various efforts that New York’s Medicaid program undertook in 2022 to accrue $3.4 billion in recoveries and cost avoidance.Continue Reading New York OMIG Issues 2022 Annual Report

The New York Office of the Medicaid Inspector General (OMIG) recently announced updates to its Self-Disclosure Program in response to feedback from Medicaid stakeholders after its revised posting in January 2023. OMIG revised its disclosure process to have two pathways for healthcare providers to report, explain, and return overpayments by creating an “Abbreviated Self-Disclosure Process” in addition to the existing full disclosure process.Continue Reading Two Pathways for Medicaid Self-Disclosures Announced by OMIG

Connecticut Governor Ned Lamont recently signed two important pieces of legislation that affect hospitals and certain Medicaid providers and programs.  First, Public Act No. 23-39, “An Act Requiring Discharge Standards Regarding Follow-Up Appointments and Prescription Medications for Patients Being Discharged From a Hospital or Nursing Home Facility” addresses new hospital discharge obligations for state hospitals.  Second, Public Act No. 23-186, “An Act Concerning Nonprofit Provider Retention of Contract Savings, Community Health Worker Medicaid Reimbursement and Studies of Medicaid Rates of Reimbursement, Nursing Home Transportation and Nursing Home Waiting Lists”, which implements various changes affecting the state Medicaid program and enrolled providers. Certain legislative changes implemented by these Acts are summarized below.Continue Reading Connecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home Facilities

This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.

On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in the highest-profile False Claims Act (FCA) case for many years, concluding that a party’s subjective belief as to whether it overcharged Medicare and Medicaid