In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...
Starting in January 2014, everyone will be required to purchase health insurance. If you are someone whose company already provides you with insurance, you can probably skip this article. But if you are elderly, purchase your insurance privately, or are one of the 24.2 percent of Texans without health insurance, you might want to read on ...
On April 20, 2020, the National Consumer Service (SERNAC) published the "Interpretative Circular on Supplier’s Good Practices in the context of the Covid-19 Pandemic", which seeks to establish the main concepts and criteria for companies to promote good commercial practices in order to protect consumers, especially with regard to their health and physical and psychological integrity ...
Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located. Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located ...
On May 16, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $350,000 settlement with MedEvolve, Inc., a practice and revenue cycle management and practice analytics software services company, to resolve alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
Financial Services Malaysia Overnight Rate as Alternative Reference Rate Bank Negara Malaysia (“BNM”) announced on 24 September that the Malaysia Overnight Rate (“MYOR”) is an alternative reference rate for Malaysia. The MYOR: will be administered and calculated by BNM as the volume-weighted average rate of unsecured overnight Ringgit interbank transactions, including BNM’s overnight monetary operations (excluding Standing Facilities) ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
In response to the coronavirus (COVID-19) we continue to undertake a series of measures to: 1. protect our employees; 2. provide continuity of support to our clients; and 3. work with critical elements of our supply chain to enable us to fulfil 1 and 2 Shoosmiths senior leadership, including our Chairperson, CEO, COO, business support Directors and business unit heads, are meeting as and when required to consider and act upon developments regarding COVID-19 ...
Following a landmark judgment issued this week, every local council in England must now keep to fixed legal time limits when reviewing the needs of children and young people with special educational needs. The annual review process involving Education, Health and Care (EHC) plans will now be subject to strict timelines following R (L,M, and P, v Devon County Council [2022] EWHC 493 (Admin). EHC plans, which must be reviewed annually, will now have to be reviewed within 12 weeks ...
Part of the fall-out of the COVID-19 pandemic is the condition labelled ‘long-covid’. This is still a relatively new condition that remains under study, but symptoms include extreme tiredness, shortness of breath, loss of smell and muscle aches. Some people experience further complications and suffer memory problems known as ‘brain fog,’ difficulty sleeping, dizziness, depression and anxiety ...
In January 2020 the first signs of Covid-19 were of a commercial nature. Business activity related to China – which is a large part of the maritime industry in Asia – started slowing down considerably. Projects experienced delays, new ventures were postponed and a general slowdown could be felt throughout the maritime business world. As February and March came around, the first Covid-19 cases started being reported in Singapore ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
In a significant victory for healthcare providers, the Sixth Circuit Court of Appeals on Monday overturned an $11.1 million False Claims Act (FCA) judgment against Atlanta-based medical imaging company MedQuest Associates, Inc. and three of its Nashville, Tennessee-area imaging facilities. The Court held that the company did not violate the FCA by failing to comply with Medicare supervising-physician regulations or Medicare enrollment regulations following a change of ownership ...
Yesterday a three-judge panel from the United States Court of Appeals for the Sixth Circuit became the first appellate court to uphold the constitutionality of the minimum coverage provision of the Patient Protection and Affordable Care Act (the “Act”), requiring that Americans obtain health insurance. Opinions are expected from the Fourth and Eleventh Circuits later this summer ...
Skilled nursing facilities have faced unprecedented challenges since the outbreak of the coronavirus pandemic. Individuals with many high-risk characteristics are the typical patients of these facilities. Add to this, necessarily close proximity of these patients, scarcity of personal protective equipment and shortage of testing common across the healthcare industry, and you have a perfect storm of increased risk with limited options for mitigation ...
Beginning July 1, 2019, the Ohio Department of Medicaid (ODM) is requiring all Ohio managed care plans to make room and board payments directly to hospice providers when hospice services are provided to individuals residing at skilled nursing facilities (SNF) ...
Key Points As of January 2022, CMS is posting each skilled nursing home's weekend staffing levels and staff turnover rates on its public-facing Care Compare website. This information will be used in the Nursing Home Five Star Quality Rating System and will affect facilities' Five Star ratings starting in July 2022 ...
