In March 2020, the State Medical Board of Ohio issued guidance temporarily relaxing Ohio’s telemedicine rules for physicians, permitting physicians to use telemedicine in place of in-person visits in many circumstances for the duration of Ohio’s COVID-19 state of emergency declaration. With Governor DeWine’s termination of the state of emergency in June of 2021, the … Continue Reading
Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially … Continue Reading
The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading
For the second time in as many years, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into settlement agreements with and levied hefty fines on three hospitals that allegedly impermissibly disclosed patients’ protected health information to ABC News in the course of filming a television network documentary series. OCR announced … Continue Reading
On Wednesday 25 April, the EU Commission unveiled a new strategy to boost Europe’s capabilities and related industries around artificial intelligence. As you know, this is a “hot topic” that has the potential to affect many businesses and sectors across Europe and beyond. Many of our clients are very interested in this technology development (and … Continue Reading
On 25 April 2018, the European Commission (EC) issued a Communication on enabling the digital transformation of healthcare, outlining the European Union’s (EU) priorities and actions towards digital health. The EU’s plan focuses on the following core priorities: Ensuring citizens’ access to their health data and introducing the possibility to share their data across borders; … Continue Reading
An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices. The regulations seek to fill the regulatory gaps uncovered as technology evolved faster … Continue Reading
Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals. FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading
On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations. The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products. However, manufacturers may not be able … Continue Reading
Telemedicine, Follow-Up Care and State Licensure: The Problem Illustrated As the delivery of healthcare services adapts to the digital age, providers, payers and patients are gradually exploring telemedicine’s possibilities. Evidence that delivering certain routine services via telemedicine may increase patient access to care and decrease cost without sacrificing quality has only served to accelerate this … Continue Reading
Only two days after releasing its latest fraud alert, a deputy director from HHS’s Office of Inspector General announced that the OIG will be hiring additional attorneys to look into taking more administrative actions against physicians in their individual capacity. This announcement emphasizes that the OIG means serious business – not only is the OIG … Continue Reading
Happy Halloween! In addition to costumes and candy, October 31 saw the release of the 2015 Work Plan by the Office of Inspector General for Health and Human Services. Always a lengthy document, the Work Plan can indicate areas that providers and suppliers want to monitor closely, as they are areas receiving attention from the government. In … Continue Reading
Last week, CMS announced that it intends to reopen the submission period for hardship exception applications for eligible professionals and eligible hospitals to avoid the 2015 Medicare payment adjustments for not demonstrating meaningful use of Certified Electronic Health Record Technology (CEHRT). This reopening process will be addressed through future rulemaking. Previously, the hardship exception application … Continue Reading
On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations. The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”) include significant easing of Conditions of … Continue Reading
Health care fraud accounts for billions of the US health expenditure each year. This week HHS published a study addressing possible deficiencies in CMS’ capability to address fraud vulnerabilities and ensure the integrity of electronic health records (“EHR”) systems which CMS and its contractors use to pay Medicare claims. Concerns about whether CMS’ oversight and … Continue Reading
On January 10, 2014, CMS will publish the proposed rule titled Medicare Program: Contract Year 2015 and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). The Proposed Rule propositions extensive reforms to the Medicare Advantage (“Part C”) and Medicare Prescription Drug Benefit Program (“Part D”), partly through … Continue Reading
On December 27, 2013, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General of the Department of Health and Human Services (“OIG”) published final rules (“Final Rules”) regarding the electronic health records (“EHR”) donations Stark Law Exception (42 C.F.R. 411.357(w)) and Anti-Kickback Statute Safe Harbor (“AKS Safe Harbor”) (42 C.F.R. … Continue Reading
With approximately two months having passed since the end of the government shutdown, the fundamental question still remains; what exactly did Congress achieve through the contentious shutdown negotiations? The shutdown was spurred in part by certain Congressional Members’ opposition to the funding and implementation of the Affordable Care Act (“ACA”). A centerpiece of these oppositional … Continue Reading
Yesterday, the U.S. Dept. of Health and Human Services Office of Inspector General (“OIG”) clarified its stance on a growing practice – provider attempts to circumvent fraud and abuse laws by structuring financial arrangements to apply only to business concerning non-Federal program beneficiaries. The OIG reiterated its dim view of this practice, citing an underlying … Continue Reading
Following the revocation of two previously certified electronic health record products to be used as part of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, Farzad Mostashari, M.D., the national coordinator for health information technology, announced that the products do not meet standards and providers cannot use these products to meet the requirements … Continue Reading
In January of 2005, the Centers for Medicare and Medicaid Services (“CMS”) finalized its regulation permitting Medicare Part D plans to establish networks of “preferred” and “non-preferred pharmacies,” meaning that the plans may offer lower cost-sharing to enrolled Medicare beneficiaries who receive items or services from a preferred pharmacy. 70 Fed. Reg. 4194 (Jan. 28, … Continue Reading
On April 1, 2013, the United States Court of Appeals for the Sixth Circuit overturned the $11.1 million judgment against MedQuest for its submission of claims to Medicare for tests in diagnostic testing facilities that were not supervised by approved physicians. The whistleblower action was initiated by a former MedQuest employee, alleging that MedQuest, a … Continue Reading
Proposed Rules Issued Extending Protections of Electronic Health Record Donations On April 10, 2013, the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the DHHS, Centers for Medicare & Medicaid Services (CMS) each issued a proposed rule relating to the donation of interoperable electronic health records software or information technology … Continue Reading
