Reversing its prior position, CMS announced on December 28, 2021, that it would begin enforcement of the COVID-19 vaccine requirement, established by the interim final rule, published November 05, 2021, in 25 states and the District of Columbia in a phased approach beginning January 27, 2022. With the announcement CMS issued guidance for surveyors regarding enforcement in S&C Memo QSO 22-07-ALL (“Memo”), describing how CMS will enforce the rule and how facilities that are non-compliant may avoid enforcement action if meeting certain threshold criteria during periods up to 90 days after issuance of the Memo as follows:
On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to protect against cybersecurity threats. This Guidance comes, in part, as a response to federal regulators sounding the alarm over an uptick in cybercrime against hospitals and other health providers. The Guidance follows an October 2020 Joint Cybersecurity Advisory issued by the Cybersecurity and ...
Cyber threats and cybersecurity controls have evolved significantly over the past two decades since the HIPAA Security Rule were originally promulgated. During this same time, healthcare entities have increasingly become a prime target of hackers seeking to extort payment using ransomware, exfiltrate patient data to commit fraud, or disrupt operations in other nefarious ways. Recognizing these challenges, some security professionals have sought further clarity on the HIPAA Security Rule that they deem to be “long in the tooth”. Yet, regulators have not made any ...
Our colleagues Susan Gross Sholinsky, Ann Knuckles Mahoney, Jennifer L. Nutter, and Eduardo J. Quiroga of Epstein Becker Green have recently published an Act Now Advisory that will be of interest to our readers: "Roadmap to Compliance: Major Employment Laws Effective as of January 2021 and Beyond".
The following is an excerpt:
While state legislatures focused much-needed attention on pandemic-related legislation throughout most of 2020, many continued to alter their employment laws in significant ways, or simply had previously passed laws scheduled to take effect at the start ...
Our Employee Benefits and Executive Compensation practice now offers on-demand “crash courses” on diverse topics. You can access these courses on your own schedule. Keep up to date with the latest trends in benefits and compensation, or obtain an overview of an important topic addressing your programs.
In each compact, 15-minute installment, a member of our team will guide you through a topic. This on-demand series should be of interest to all employers that sponsor benefits and compensation programs.
In our newest installment,
On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division's 2017 guidance publication “Evaluation of Corporate Compliance Programs.” In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.” He noted that DOJ also sought “to provide additional transparency in how [it] will analyze a company's ...
The Health Care Compliance Association (HCCA) kicked off its 22nd Annual Compliance Institute on Monday, April 16, 2018. During the opening remarks, Inspector General Daniel Levinson, of the Department of Health and Human Services (HHS) Office of Inspector General Office (OIG), announced the rollout of a new public resource to assist companies in ensuring compliance with Federal health care laws. The Compliance Resource Portal on the OIG’s website features:
- Advisory opinions
- Provider Compliance Resource and Training
- Voluntary Compliance and Exclusions ...
Both the Department of Justice and the Department of Health and Human Services Inspector General have long urged (and in many cases, mandated through settlements that include Corporate Integrity Agreements and through court judgments) that health care organizations have "top-down" compliance programs with vigorous board of directors implementation and oversight. Governmental reach only increased with the publication by DoJ of the so-called Yates Memorandum, which focused government enforcers on potential individual liability for corporate management and directors in ...
Our colleagues at Epstein Becker Green released a client alert: "DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations," by George B. Breen, Jonah D. Retzinger, Marshall E. Jackson Jr., and Stuart M. Gerson.
Following is an excerpt:
Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the attorney-client privilege attached to internal compliance ...
Several colleagues and I recently wrote Health Reform: Key Compliance Actions for the New HIPAA Privacy Regulations, an alert published by the Implementing Health and Insurance Reform team of Epstein Becker Green.
In it, we summarized areas in which employers should consider taking action prior to September 2013 to facilitate compliance with the new requirements. Here are our top five action items for covered entities and business associates to focus on in their Omnibus Rule compliance efforts:
- Review Business Associate Relationships, and Update Business Associate ...
Now that the Supreme Court of the United States has upheld essentially all of the provisions of the Obama administration’s Affordable Care Act (“ACA”), employers are faced with looming deadlines to bring their group health plans into compliance with the ACA’s numerous new requirements. We have prepared for employers a timeline of the highlights of the upcoming deadlines for compliance with the ACA that apply to non-grandfathered group health plans.
Now that the Supreme Court of the United States has upheld essentially all of the provisions of the Obama administration's Affordable Care Act ("ACA"), employers are faced with looming deadlines to bring their group health plans into compliance with the ACA's numerous new requirements. We have prepared for employers a timeline of the highlights of the upcoming deadlines for compliance with the ACA that apply to non-grandfathered group health plans.
- DOJ’s FY 2023 Statistics: Highest Number of Settlements, Judgments, and Civil Investigative Demands in History and a Continued Health Care Focus
- FDA Releases Updated Directory on Select Dietary Supplement Ingredients
- In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute
- NJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders
- Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities