Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly: 3D Printing of Manufactured Goods: … Continue Reading
The HHS Office of Civil Rights (“OCR”) published a final rule May 18, 2016, broadening the nondiscrimination requirements applicable to all health programs and activities receiving federal financial assistance from HHS, those administered by HHS, and Health Insurance Marketplaces. The final rule implements section 1557 of the ACA and adds two important categories of protections: … Continue Reading
In a ruling particularly meaningful to health care companies, who are responsible for patients’ protected, personally-identifiable information, the U.S. Court of Appeals recently upheld a lower court’s decision finding coverage under a healthcare company’s comprehensive general liability (CGL) policy. When the health care company inadvertently made certain confidential medical records accessible to the public online … Continue Reading
3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly. Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles. This paper explores unchartered legal issues … Continue Reading
The Department of Health and Human Services (HHS) and Office of Inspector General (OIG) issued Advisory Opinion 15-11 stating that the OIG will not impose sanctions on individuals for a program that provides free drugs to patients experiencing late insurance approvals. The OIG concluded that, although the arrangement has the potential to generate improper payment under … Continue Reading
When a data breach is discovered by a company, it is often the responsibility of the company’s in-house counsel to swiftly assess the breach and provide an initial report to company management. There are several steps that in-house counsel should follow if faced with a breach to allow for an adequate assessment that company management can use. As noted … Continue Reading
In the wake of the New York Attorney General's recent enforcement actions against four major retailers who allegedly sold herbal supplements that did not contain labeled ingredients or contained ingredients not explicitly identified on the labels, companies throughout the supply chain should consider examining their insurance policies to see whether or not they are sufficiently covered in the event of an investigation, enforcement action and/or litigation. Types of insurance policies that may provide coverage for affected companies are commercial general liability (CGL), directors and officers liability (D&O), errors and omissions liability (E&O), and product recall.… Continue Reading
According to a recent study, the median amount of time between a breach of a company's cybernetwork and the discovery of that breach is 229 days. Given this lengthy amount of time, companies should consider the benefits of an expanded cyberliability insurance policy period, particularly if the company is switching from one insurance provider to another. This topic is discussed in "Hackers Don't Care About the Terms of Your Insurance Policy: The Importance of Retroactive Dates and Extended Reporting Periods in Effective Cyberliability Insurance Coverage," a client alert written by Reed Smith's Insurance Recovery Group.… Continue Reading
The number of qui tam actions brought under the False Claims Act (FCA) has increased over the past several years. There are now more opportunities for potential allegations of FCA violations on the part of health care providers, and more eligible whistleblowers to bring those alleged violations to the government's attention. Given these circumstances, providers should take time to assess their current insurance coverage for defending and resolving FCA claims.… Continue Reading
Reed Smith’s Policyholder Perspective blog recently posted about an October 21, 2014 ruling in the U.S. District Court in South Carolina that sounds as if it came from a Hollywood film. In Evanston Insurance Company v. Agape Senior Primary Care, et al., 2014 WL 5365679, the court held that despite a false application for professional … Continue Reading
Earlier this week, numerous media outlets reported on the Russian crime ring which had managed to steal more pieces of Internet data than any other group of hackers in history – a whopping collection of at least 1.2 billion user name and password combinations and over 500 million email addresses. The magnitude of data that … Continue Reading
On December 11, 2013, CMS released an advance notice of proposed rulemaking soliciting comments on specific practices for which civil monetary penalties may or may not be imposed for failure to comply with Medicare Secondary Payer reporting requirements. Among other issues, CMS is seeking comments and proposals on mechanisms and criteria that it would use to evaluate whether and when it would impose penalties for noncompliance with Medicare Secondary Payer reporting requirements.… Continue Reading
This post was written by Paul E. Breene, Douglas E. Cameron, James M. Davis, John N. Ellison, Ann V. Kramer, Richard P. Lewis, Matthew J. Schlesinger, John D. Shugrue and Gary S. Thompson. Hurricane Sandy left a swath of major damage and destruction over a large area of the Northeastern United States. Commercial policyholders will … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
This post was written by Mark S. Hersh and Paul E. Breene. Government investigations can be both time-consuming and hugely expensive. Earlier this year, the U.S. Department of Justice and the U.S. Department of Health and Human Services announced that its 2011 health care fraud prevention and enforcement efforts resulted in record-breaking recoveries totaling more … Continue Reading
Last week, the Sixth Circuit ruled largely in favor of Stryker Corporation in its effort to secure insurance coverage from XL Insurance America. Since 2001, Stryker has been battling XL for reimbursement of its defense and indemnity costs arising from sales of expired Uni-Knees, an artificial knee medical device. Stryker had accidentally permitted sales of the expired products from its warehouse until it discovered the error.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has recently updated the information on its website with respect to the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), Section 111 "Mandatory Insurer Reporting" requirements. The recent updates cover (1) a revised implementation timeline for certain liability insurance (including self-insurance) total payment obligation to claimant settlements, (2) revised guidance on claims involving exposure, ingestion, and implantation issues, (3) upcoming improvements to the Medicare Secondary Payer (MSP) program, (4) a new exception for certain settlements paid into a qualified settlement fund and (5) a new way for certain injured Medicare beneficiaries to satisfy their past and future MSP obligations.… Continue Reading
In a highly anticipated decision, the California Supreme Court yesterday decided the issue of whether tortuously injured plaintiffs with private health insurance get to recover the full rate charged by their doctors and hospitals or the discounted, contract rate their insurers actually pay.
The standard, the California Supreme Court held in Howell v. Hamilton Meats & Provisions, is that personally injured plaintiffs may recover, at most, the dollar amount that actually is paid by their insurers for plaintiffs' medical services, not the larger amount that generally is billed to those not covered by negotiated contracts between insurance companies and medical providers.… Continue Reading
On May 11, 2009, Senate Finance Committee Chairman Max Baucus (D‐Mont.) and Ranking Member Chuck Grassley (R‐Iowa) released their policy options for expanding health care coverage, including options for designing a government-run public health insurance plan. Members are scheduled to meet to discuss these options on May 14, and public comments will be accepted on … Continue Reading
Lawyers representing clients as plaintiffs in litigation often overlook the fact that a cross-complaint or counterclaim may give rise to an obligation by the client’s liability insurer to provide a defense. A recent decision in favor of Hewlett-Packard, awarding it $51 million, serves as a reminder that insurance coverage must be examined when a cross-complaint … Continue Reading
This post was written by Darren Smith, Julia Dodds, and Claire Hamm. The UK has an estimated 3,000 deaths per year from mesothelioma, the lung cancer caused by inhalation of asbestos fibres. This rate of incidence shows no signs of slackening, a result of the historic exposure of the UK workforce to asbestos, and is … Continue Reading
