Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.
Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.
To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.
On November 15, 2019, the Centers for Medicare and Medicaid (“CMS”) published the 2020 Physician Fee Schedule Final Rule in the Federal Register. Among the several changes outlined in the rule, this post specifically focuses on the changes to documentation requirements for Evaluation and Management (“E/M”) Visits. The first important note is the CMS will maintain the existing documentation requirements for all E/M codes for the year 2020.
However, in an effort to update the currently applicable guidelines (published in 1995 and 1997), the E/M documentation requirements will be revamped in 2021 for office visits only. In other words, the emergency department E/M code documentation will remain unchanged. But the focus of the E/M code documentation for office visits will be based solely on Medical Decision-Making (“MDM”) or E/M visit time with patient. Continue reading “Insurers Preempting Upcoming Changes for E/M Visit Documentation”
On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule that strengthens a number of enforcement measures. The new rules go into effect beginning November 4, 2019. The goal for CMS is to keep those providers and suppliers that have committed fraud out of the federal healthcare programs.
For one, the new final rules provide CMS with new revocation and denial authorities, as part of the Provider Enrollment Process, for “affiliations” that pose an undue risk of fraud, waste or abuse. Continue reading “New CMS Final Rule Strengthens Enforcement Authorities To Bolster Fraud and Abuse Prevention”
Disability discrimination lawsuits against hospitals have become relatively common in recent years as former hospital employees allege that their former employers discriminated against them on the basis of various disabilities in violation of the Americans with Disabilities Act of 1990. Other ADA lawsuits have been filed against hospitals and other healthcare providers, claiming that their websites or parking lots do not adequately accommodate those with disabilities. Yet others have been filed accusing hospitals of failing to accommodate deaf patients by not providing a live interpreter. But few, if any, major lawsuits had been brought against hospitals and healthcare providers alleging that the facilities themselves fail to accommodate patients with physical disabilities. That may have changed with a putative class action lawsuit filed in the U.S. District Court for the Western District of Pennsylvania in late July, which may be the first of many cases to come.
View the full Alert on the Duane Morris LLP website.
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
Read the full text of this Alert on the Duane Morris LLP website.
By Lisa W. Clark and Erin M. Duffy
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) finalized revisions to the Confidentiality of Substance Use Disorder Patient Records regulations, found in 42 CFR Part 2. The new final rule implements the changes proposed a year ago by SAMHSA in its supplemental notice of proposed rulemaking (SNPRM), which was issued alongside the first major changes to the federal regulations governing Part 2 covered data since 1987. After receiving public comment on the SNPRM, SAMHSA has finalized provisions relating to the disclosure of patient-identifying substance use information for payment and healthcare-related purposes and the disclosure of patient-identifying substance use information for the purposes of carrying out a Medicaid, Medicare or Children’s Health Insurance Program (CHIP) audit or evaluation. The new final rule also permits lawful holders to issue an abbreviated notice of the prohibition on redisclosure to accommodate electronic health record systems with standard character limitations on free text fields.
Read the full story on the Duane Morris LLP website.
In a 5-3 decision today, the Supreme Court of the United States in Whole Woman’s Health v. Hellerstedt, No. 15-275, slip op. (June 27, 2016) reversed a decision of the Fifth Circuit and overturned as unconstitutional a Texas law that (1) required abortion providers to have “active admitting privileges” at a hospital within 30 miles of the location at which they provide abortions and (2) required abortion facilities to meet standards adopted for ambulatory surgery centers. The Court wrote that each of the requirements “places a substantial obstacle in the path of women seeking a previability abortion, each constitutes an undue burden on abortion access, and each violates the Federal Constitution.” A team of Duane Morris attorneys, including Philip H. Lebowitz, Erin M. Duffy, Katharyn I. Christian McGee, Alison Taylor Rosenblum, and Erica Fruiterman, filed an amicus curiae brief on behalf of medical staff professionals in support of petitioners Whole Woman’s Health et al. In its decision, the Supreme Court cited Duane Morris’ amicus brief, noting, “Other amicus briefs filed here set forth without dispute other common prerequisites to obtaining admitting privileges that have nothing to do with ability to perform medical procedures.” The brief was one of only a handful of amici curiae briefs cited in the decision out of a total of 41 such briefs filed on behalf of petitioners.
Duane Morris partner Frederick Ball and associate Erin Duffy will present at the “Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation” program on Thursday, November 7, 2013 at the Hyatt Regency New Brunswick in New Brunswick, New Jersey.
This introductory program provides a comprehensive overview of the laws and Food and Drug Administration regulations affecting the drug industry, and will help you and your organization get products approved and navigate regulatory problems. Experts will review the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied.
For more information please visit the Food and Drug Law Institute website.