The coronavirus creates a situation for the world, for the Netherlands and for the Dutch health care that most of us have never experienced before. As the healthcare & life sciences market group, we are confronted with this event in various ways. In our business and private lives, but also mainly because we see what the impact is for our clients. We are very looking for the best way to deal with this ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets ...
On Jan. 15, 2019, the Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) shared a bulletin published by the Office of the Assistant Secretary for Preparedness and Response, Critical Infrastructure Protection Public-Private Partnership (ASPR CIP) regarding a number of vulnerabilities identified in Microsoft Windows operating systems, which if not addressed, pose significant a threat to the environment. On Jan ...
On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations. The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org, a non-governmental website marketing consulting service ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
On April 10, Health and Human Services (“HHS”) began providing a $30 billion portion of the latest COVID-19 relief fund to healthcare providers. Information on this funding may be found here. While the government announced this funding as coming with “no strings attached” in its April 7 briefing, the relief payment (the “Payment”) does come with certain terms and conditions that a provider must certify compliance with ...
Since the Department of Health and Human Services (HHS) Provider Relief Funds (PRF) first started arriving in provider bank accounts on April 10, 2020, HHS has stated that it will issue additional guidance “soon” on mandatory reporting requirements on how use of funds must be reported. The PRF funds are among the funds Congress appropriated to reimburse eligible healthcare providers for healthcare-related expenses or lost revenues attributable to COVID-19 ...
The U.S ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
Details regarding a new Medicare payment model for radiation oncology care have been released by the Department of Health and Human Services (HHS). The new Radiation Oncology Model (RO Model) qualifies as an Advanced Alternative Payment Model (APM) and a MIPS APM under the Quality Payment Program. According to this release from HHS, the RO Model aims to “promote quality and financial accountability for providers and suppliers of radiotherapy ...
The Department of Health and Human Services (HHS) has implemented a new Medicare payment model, the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model. The ETC Model was developed to test whether the greater use of home dialysis and kidney transplantation for Medicare beneficiaries with ESRD will reduce Medicare expenditures, while also preserving or enhancing the quality of care furnished to beneficiaries with ESRD ...
A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic ...
Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...
