As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
Last week upon final passage by Congress, President Joe Biden signed the American Rescue Plan Act (ARPA or Act) into law.[1] The $1.9 trillion economic stimulus bill provides a comprehensive package of available funds to qualifying individuals and businesses in the form of direct payments, industry-specific grants, and tax credits ...
Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...
On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021 ...
On March 10, 2021, the Centers for Medicare & Medicaid Services (CMS), in association with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to resume visitation options during the COVID-19 pandemic. Nursing homes have been devastatingly effected by COVID-19, with outbreaks causing high rates of infection and death ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
On March 8th, 2021, the government announced that, due to the current status of the Covid-19 pandemic in Chile, it was decided to extend the enforcement of the benefits and entitlements of the employment protection law, protected parenting law and law that temporarily amends the requirements to access to the unemployment insurance. Additionally, the coverage and amounts of the benefits of the Employment Subsidy will be increased ...
It is well established under Ohio law that an injured worker is not eligible to participate in the workers' compensation system for a psychological condition unless it arises from their physical injury. While this remains the case, an exception is being considered to allow first responders to receive benefits should they experience post-traumatic stress disorder due to on-the-job factors. In Armstrong v. John R. Jurgensen Co ...
2020 was an especially active year for FCA enforcement. What does this tell us about compliance in the coming year? Bradley Government Enforcement and Investigations partners Jon Ferry, Ty Howard, and Brad Robertson discuss how the enforcement environment drives compliance, and the areas of risk companies need to focus on this year ...
On Monday, March 8, 2021, President Joe Biden issued a new executive order, which will require a new look at how schools address sex discrimination ...
Brexit and other developments such as the Schrems 2.0 judgment have had and will have a significant impact on, in particular, data protection laws that apply and how businesses transfer their data internationally. What does the EU-UK Trade and Cooperation Agreement say? Data protection is not dealt with in much detail in the Trade Agreement, although it includes a ‘temporary bridge’ mechanism for the free flow of personal data from the EU/EEA to the UK ...
On February 24th, 2021, the President has signed the law increasing administrative penalties for the breach of personal data laws and introducing new penalties for the breach of information laws. The law enters into force on March 27th, 2021. Liability terms for communication providers’ failure to en-sure sustainable operation enter into force on February 1st, 2023 ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
The Government Accountability Office (GAO), in Spartan Medical, Inc., B-419503,1 recently clarified the scope of its jurisdiction over bid protests involving an agency's use of its other transaction agreement (OTA) authority. The GAO's decision in this case is noteworthy because agencies are increasingly relying on OTAs to meet their procurement needs ...
Signals from the SEC regarding the growing importance to the Commission of ESG disclosures keep coming, seemingly daily. The recently appointed acting director of the Division of Corporation Finance has long pushed the agency for “relevant, material, decision-useful ESG disclosure.” More recently, the SEC announced the creation and filling of the position of senior policy advisor for climate and ESG in the office of Acting Chair Allison Herren Lee ...
There were a lot of good green measures in the Budget and the government deserves credit for recognising the vital role that net zero transition will play in determining our future prosperity. Not just building back stronger but building back greener, with reference clearly made to the role the headline announcement of Freeports will have in supporting the delivery of the UK’s clean energy revolution ...
The Supreme Court has declined to take up the issue of False Claims Act (FCA) “objective falsity” in relation to medical opinions, denying certiorari in paired cases from the Third Circuit (United States ex rel. Druding v. Care Alternatives, Inc.)[1] and Ninth Circuit (Winter ex rel. United States v. Gardens Reg’l Hosp. & Med. Ctr., Inc.) ...
On 19 February 2021, the Supreme Court handed down a landmark judgment which confirmed that Uber drivers are workers and not independent contractors. We look at the basis for the decision and what it means for other employers. Background This case began back in 2016, when Uber drivers Mr Aslam, Mr Farrar and others submitted a claim to the Employment Tribunal (ET) regarding their employment status ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...
The Federal Acquisition Regulation (FAR) Council recently issued its long-awaited final rule1 limiting the ability of civilian agencies to use the Lowest Price Technically Acceptable (LPTA) procurement method. The final FAR rule — which took effect on February 16, 2021, and largely tracks the language contained in the Defense Federal Acquisition Regulation Supplement (DFARS) final rule from 2019 2 — is codified at FAR 15.101-2 ...
With the new year comes a new president. Will the new year and administration also bring new water policy? Bet on it. Just as President Trump undid President Obama’s signature water policy decision—the Clean Water Rule, which clarified and arguably expanded federal water permitting jurisdiction—President Biden is likely to rewind many of President Trump’s water policy (and, more generally, environmental policy) decisions over the next four or more years ...
On 25 February, 2021 the triumvirate of European Supervisory Authorities, the EBA, EIOPA and ESMA (the "ESAs") published a joint statement on the effective and consistent application and national supervision of the Sustainable Finance Disclosure Regulation ("SFDR"). The joint statement is intended to help mitigate the risks of divergent application of the SFDR, and promote a level playing field to protect investors ...
Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation ...
San Francisco Superior Court Judge Ethan Schulman ruled yesterday that Cal/OSHA can continue to enforce its COVID-19 Emergency Temporary Standard Regulation (ETS), at least for now. On February 25, 2021, Judge Schulman issued an order denying Plaintiffs' applications for a preliminary injunction halting enforcement of the Cal/OSHA's COVID-19 Emergency Temporary Standard Regulation (ETS) in two cases ...
