On October 14, 2021, the Massachusetts Attorney General’s Office announced a $25 million healthcare fraud settlement against a private equity firm and former executives of the firm’s portfolio company. The settlement is significant because it is the largest healthcare fraud settlement in the country to date against a private equity firm based on the firm’s oversight of its healthcare portfolio company ...
The Centers for Medicare & Medicaid Services (CMS) recently released a final rule, which will require hospitals to publicly disclose pricing information, effective January 1, 2021 ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
President Joe Biden announced Thursday, Sept. 9, that in the coming weeks, companies with 100 or more employees will be required to ensure their employees are vaccinated against COVID-19 or test negative for COVID-19 at least once a week.[1] Additionally, employers must provide employees time off to get vaccinated and to recover from any side effects. Press Secretary Jen Psaki previewed the forthcoming requirements in her briefing to the press on Thursday ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
At any hour, your company is vulnerable to cybercriminals aiming to cripple your operations. The repercussions are vast, from productivity loss to compromising sensitive information, which erodes trust with customers and employees alike. The financial toll and reputational harm can be severe and lasting. Whether facing a widespread assault or a precise strike, these attacks are escalating in frequency, sophistication and financial impact ...
Plaintiffs’ counsel in pharmaceutical product liability cases continue to pursue depositions of company sales representatives and seek to elicit testimony supporting their common theme that pharmaceutical companies disregard the health and safety of their consumers in the dogged, single-minded pursuit of sales and profits ...
On 6 April 2022, Shoosmiths hosted the second in a series of webinars about the UK COVID-19 Public Inquiry. The webinar focussed on the current status of the inquiry and gave practical tips for potentially interested parties. Hosted by Hayley Saunders (Partner), the webinar included talks by Charles Arrand (Partner), Alex Friston (Associate) and Hannah Frost (Associate) ...
The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...
On June 10, 2021, the Standing Committee of the National People’s Congress adopted the Anti-Foreign Sanctions Law (the “Anti-Sanctions Law”) ...
President Donald Trump announced that the federal government will halt payments known as cost share reduction (CSR) payments. The CSR payments amounted to approximately $7 billion this year, and served as a subsidy to enable lower-income Americans to afford health insurance coverage ...
Within hours of the U.S. Supreme Court’s decision overturning Roe v. Wade, Ohio’s Heartbeat Bill, originally passed in 2019, became effective when the U.S. District Court, Southern District of Ohio, lifted its long pending injunction against the Ohio law ...
On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...
The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...
As the COVID-19 outbreak spreads and officials recommend or impose increasingly restrictive steps to mitigate the impact to public health, more companies are assessing what impact the outbreak is likely to have on their business and are considering whether that impact may necessitate furloughing workers. Following is a summary of some of the core compliance issues employers should consider as they develop contingency plans that may include furloughs ...
Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...
As healthcare providers pursue transactions during and in the wake of COVID-19, both buyers and targets should prepare for heightened scrutiny during the due diligence process. Getting organized ahead of a sale can dramatically expedite timelines and reduce deal fatigue for all parties, particularly in light of the heavier-than-normal due diligence process as a result of the pandemic. Click here for a full PDF of this report ...
The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
