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If our trade and industry sources have it right, we could see final regulations implementing the Mental Health Parity and Addiction Equity Act (MHPAEA), as most recently amended by the Consolidated Appropriations Act, 2021...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
NAVEX recently hosted a webinar in partnership with Granite GRC about the recent updates to the U.S. Department of Justice (DOJ) and the current Evaluation of Corporate Compliance Programs (ECCP). This posts answers questions...more
The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more
Last month, CMS issued three civil monetary penalty (CMP) notices for violations of the hospital price transparency regulations (HPT Rule), which requires hospitals to make public the standard charges of the items and...more
This is the second article in a three-part series where Ankura privacy experts analyzed the 40 examples of non-compliance with the California Consumer Privacy Act (CCPA) published by the California Office of Attorney General...more
On November 9, 2022 the Department of Health and Human Services Office for Human Research Protections (OHRP) published a new Guidance clarifying the requirements for reporting incidents to OHRP. Questions about OHRP reporting...more
Report on Research Compliance 19, no. 5 (May, 2022) - Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS...more
On November 30, 2021, the Office for Civil Rights (“OCR”) at the United States Department of Health and Human Services (“HHS”) announced the resolution of five investigations in its Health Insurance Portability and...more
Report on Research Compliance 18, no. 12 (December, 2021) - A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...more
The U.S. Department of Health & Human Services (HHS) just announced increased penalty amounts for entities who violate the privacy, security, and breach notification rules under the Health Insurance Portability and...more
On April 28, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) entered into a resolution agreement with Peachstate Health Management, LLC, doing business as AEON Clinical Laboratories...more
Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
Last week, the Department of Labor (DOL) announced that it will focus on requesting information from employers where there are potential “red flags” of non-compliance with the provisions and rules of the Mental Health Parity...more
Group health plans and insurers have been required since 2008 to ensure that any “nonquantitative treatment limitations” (NQTLs) imposed on mental health or substance use disorder (MH/SUD) benefits are comparable and no more...more
In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021 (the “Rule”), which requires hospitals to make public “a machine-readable file containing a...more
On April 13, 2021, four key lawmakers in the U.S. House of Representatives wrote to the U.S. Department of Health and Human Services (HHS) expressing concern over reports of non-compliance with hospital price transparency...more
A March 11 article in the Health Care Compliance Association’s Report on Patient Privacy, “In Wake of 16th OCR Settlement, Time For CEs, BAs to Take Right of Access Seriously,” discussed the Right of Access Initiative that...more
Report on Medicare Compliance 30, no. 8 (March 1, 2021) - According to a CMS spokesperson, “CMS has not yet determined when Targeted Probe and Educate reviews will resume.” Meanwhile, “CMS continues to temporarily pause...more
Report on Medicare Compliance 29, no. 45 (December 21, 2020) - CMS said Dec. 18 it will audit a sample of hospitals for compliance with price transparency requirements, which take effect Jan. 1, according to MLN Connects....more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently released an audit report on HIPAA compliance by 166 covered entities and 41 business associates during 2016-2017. The audits included...more
West Georgia Ambulance, Inc. (West Georgia) and the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Service (HHS) entered into a $65,000 no-fault settlement agreement and two year corrective action...more