The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The First Circuit will decide whether the FCA “result[s] from” a kickback if that claim would not
Regulatory Compliance
Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’ (“District Court”) declaring unlawful and vacating a portion of an HHS-OCR Bulletin…
AB 3129 Passes California Legislature, Targeting Private Equity Health Care Transactions and Granting AG Consent Right
By David Manko, Vinay Kohli, Jonian Rafti & Michael Menconi on
On August 31, 2024, the California State Assembly and State Senate passed Assembly Bill 3129 (“AB 3129”). If signed by Governor Newsom, AB 3129 would establish a comprehensive transaction review law that (i) targets private equity firms and hedge funds, and (ii) grants the Attorney General explicit consent rights over…
CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments
By Matthew J. Westbrook & Whitney Phelps on
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. § 401.305(a) regarding the standard for an “identified overpayment” under Medicare Parts A–D…
OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28, 2024, OIG published a report (“OIG Report”) summarizing its finding that, of the NIH‑funded clinical trials randomly selected by OIG for review, a majority failed to meet NIH’s requirements for inclusion of diverse trial participants.
New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive Health Care Information
By Whitney Phelps & Michael Menconi on
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Final Rule, which goes into effect on June 25, 2024, promulgates…
Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA Violation Predicated on an AKS Violation
By Matthew J. Westbrook & Vinay Kohli on
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute (“AKS”) is a predicate violation for the false claim. The spotlight is now on…
Public Portal to Promote Healthy Competition
On Thursday, April 18, the Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”), and the Department of Health and Human Services (“HHS”) announced the launch of an online portal that allows the public to report potential health care antitrust violations.
The portal, HealthyCompetition.gov, aims to advance government efforts…
Oregon CPOM Bill Inches Closer to Becoming Law, Targeting Investors and the PPM/Friendly PC Model
By Jason S. Madden, Jonian Rafti & Michael Menconi on
Update as of 3/13/24:
House Bill 4130 died on March 4, 2024, after it failed to reach the Senate Floor. Representative Ben Bowman, the Bill’s chief sponsor, pledged to reintroduce the Bill as soon as the opportunity arises. The Bill garnered national attention as the latest state-led effort to regulate…
NYS DFS Revisits PBM Regulation with Scaled-Back Draft Rules
By Ashley Seibler & Whitney Phelps on
On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in New York.
The draft regulations represent DFS’s latest attempt to promulgate PBM market conduct rules following state PBM licensing legislation that was enacted in 2021. In August 2023, DFS issued proposed regulations addressing consumer protection, conflicts of interest, and transparency issues related to PBM industry practices, including a dispensing fee of $10.18 per drug claim to be paid to pharmacies, but the proposed regulations were later withdrawn by the agency in October 2023 following the public comment period.
DFS’s announcement of the draft regulations and pre-proposal comment period stated that the draft regulations were informed by DFS’s “extensive outreach to industry, health plans, pharmacy groups, state and federal regulators, and the general public.”