Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
Does your compliance program incorporate quality and patient safety issues? Or, are you treating the two areas as separate and distinct departments? The OIG’s General Compliance Program Guidance recommends all healthcare...more
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more
According to a survey conducted by KPMG, 75% of companies are not in a position to obtain third-party assurance on their published ESG data. This is despite the fact that two-thirds of companies must disclose such data, or...more
While many licensed professionals generally understand the responsibility of the board that regulates their practice, the Defense Health Agency's ("DHA") role in professional licensing issues is not as widely known. However,...more
On March 22, the Department of Defense (DOD) issued a proposed rule that would amend the Defense Federal Acquisition Regulations (DFARS) to require certain contractors to provide the Defense Contract Management Agency (DCMA)...more
On October 21, 2022, the Centers for Medicare and Medicaid Services (CMS) announced changes to its Special Focus Facility (SFF) program, including new steps to address nursing home facilities that fail to graduate from the...more
Primum non nocere is a Latin phrase that means “first, do no harm.” This principle is commonly taught in healthcare. In fact, the Hippocratic Oath, taken by doctors, promises they will abstain from doing harm to their...more
Recently, in Siegel v. Snyder, Slip.Op. 07624, New York’s Appellate Division, Second Department interpreted New York’s peer review/quality assurance confidentiality statute in a manner that may require modifications to the...more
ACI’s 27th Annual Flagship Conference on Regulatory Compliance for Financial Institutions will take place virtually on November 23 – 24, 2021 (EST). Join regulators and industry peers for a series of in-depth discussions...more
CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance...more
In roughly the seventh week after a majority of states and the federal government issued emergency declarations or "lock down" executive orders, the true impact of COVID-19 is only beginning to be fully transparent. In long...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released a Quality, Safety & Oversight Group (QSO) memorandum (QSO-20-22-ASC, CORF, CMHC, OPT, RHC/FQHCs) addressing standards for infection control and...more
The Armed Services Board of Contract Appeals’ recent decision in Appeal of Watts Constructors, LLC gave life to a contractor’s claim that the government violated its implied duty of good faith and fair dealing. Under a...more
Healthcare in the United States is at a crossroads, with technology, new market “disrupters,” and seemingly intractable problems converging. At least that was the central theme we observed at the annual meeting of the...more
Last month, we wrote that the Arkansas Court of Appeals had recently affirmed the critically important quality-assurance privilege in Arkansas, codified at Arkansas Code Annotated section 16-46-105...more
The Arkansas Court of Appeals recently affirmed the critically important quality-assurance privilege in Arkansas, codified at Arkansas Code Annotated section 16-46-105. At issue was whether a hospital must convene a formal...more
On November 20, 2018, the Centers for Medicare and Medicaid Services (CMS) announced a new program designed to improve nursing home residents’ safety and quality. ...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
The Bankruptcy Court for the Central District of California examined the scope of the doctrine of recoupment for Medicaid and related payments, allowing the deduction by the state. The court held that the California...more
On January 4, 2017, EPA issued a notice of intent to revoke Genscape’s ability to verify Renewable Identification Numbers (RIN) as a third party auditor under the Renewable Fuel Standard (RFS) Quality Assurance Program (QAP)....more
On October 4, the Centers for Medicare and Medicaid Services (CMS) published the biggest overhaul to federal long-term care regulations since 1991, and impacted facilities can immediately take steps to ensure they’re prepared...more
Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more