Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...
On Friday, September 22, 2017, the Department of Education, Office of Civil Rights (OCR) officially withdrew two guidance documents issued under the Obama administration regarding implementation of Title IX on school campuses. In place of these guidance documents, the OCR issued new interim guidance documents regarding how schools should handle sexual assaults. The OCR indicated official guidance and directives will be issued after a formal notice and comment period ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...
Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...
As concern over cybersecurity continues to grow,[1] defense contractors have been waiting for the Department of Defense (DoD) to roll out its Cybersecurity Maturity Model Certification (CMMC) program. That rollout has occurred, with DoD’s recently published interim rule Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)[2] (“Interim Rule”), effective Nov. 30, 2020, and providing for a five-year phase-in of CMMC ...
In an opinion issued on June 5, 2023, the Federal Circuit provided a useful framework for overcoming obviousness rejections during patent prosecution, where a proposed modification to a prior art reference renders it unsatisfactory for its intended purpose.[1] Appropriately applying this framework may provide a strong position against a motivation to combine references, or otherwise modify a prior art device in an obviousness rejection. In Medtronic, Inc. v. Teleflex Innovations S.A.R.L ...
In preparation for H-1B CAP Registration season, the Department of Homeland Security (DHS) has issued a final rule that limits each foreign worker to one entry into the H-1B lottery system. The H-1B Registration process had previously required companies, or other petitioners, to register with the U.S. Citizenship and Immigration Service (USCIS) and submit their requests for the individuals they sought to sponsor as part of the H-1B process ...
Introduction The United States Trustee Program is part of the United States Department of Justice and oversees the administration of bankruptcy cases, including oversight of panel trustees. When a bankruptcy court grants a motion to appoint a Chapter 11 trustee, the United States Trustee (“UST”) is responsible for selecting and appointing the individual who will serve in such capacity ...
Unfortunately, financial exploitation is a significant and growing area of concern, particularly with elderly investors or those with diminished capacity. Investment advisers are facing a client base who is increasingly older, and with that comes the increased likelihood of an investment adviser encountering possible financial exploitation ...
On December 3, the U.S. Patent and Trademark Office (“USPTO”) will make a major change to how it processes trademark applications, which is anticipated to affect filing strategies, work flow, and even budgets. Brand owners in the U.S. might be wondering what they need to know about the Trademark Modernization Act’s (“TMA”) shortened office action response deadline ...
On August 19, 2022, the Office of Federal Contract Compliance Programs (“OFCCP”) published that it had received a Freedom of Information Act (“FOIA”) request from a journalist with the Center for Investigative Reporting. The request sought the disclosure of EEO-1 Type 2 Consolidated Report data filed annually by prime federal government contractors and first tier sub-contractors (“covered contractors”) ...
About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...
The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services (HHS) announced a Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Second Extension”) ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
TOP STORY: Coronavirus (COVID-19) In recognition of the unique hardships presented by Novel Coronavirus/COVID-19, the SEC has issued a variety of relief orders across the securities industries. Many of these have come in the form of deadline exemptions or extensions. Our newsletter is focused on providing updates and information primarily concerning the investment advisory business ...
On Nov. 30, 2020 the North American Securities Administrators Association (NASAA) announced that its membership voted to adopt a model rule to set parameters by which NASAA members could implement continuing education programs for investment adviser representatives (IARs) in their jurisdictions. Following is a summary of the provisions of the model rule ...
On January 11, 2023 the SEC Division of Investment Management issued an additional Marketing Rule FAQ. The newly issued FAQ addresses gross and net performance requirements applicable to private fund case studies, single investments and/or groups of investments, i.e. extracted performance. Specifically, the Question provides as follows: Q. When an adviser displays the gross performance of one investment (e.g ...
On January 5, 2023 the SEC announced a settled Administrative Proceeding with Randy Robertson. Mr. Robertson previously served as the co-portfolio manager for the BlackRock Multi-Sector Income Trust (“BIT”). While serving as the co-portfolio manager for BIT, Mr. Robertson explored the possibility of a BlackRock investment opportunity regarding a potential secured lending investment relating to print and advertising expenses associated with film distribution. Mr ...
Dinsmore Intellectual Property Partner Adrian Cyhan and Christopher Smith of Brooks Kushman wrote the following article, "Dawn of a New Era: Licensing Standards in the Coming Age of 5G" for The Licensing Journal. 5G: What’s the Big Deal? The advent of 5G cellular wireless technology represents a major advance in speed and bandwidth of wireless communications ...
On January 10, the United States District Court for the District of Columbia issued a long-awaited opinion which will allow the U.S. Department of Health and Human Services (HHS) to determine the means by which it will repay inappropriate cuts it levied against 340B participating hospitals’ Medicare reimbursement.[i] The District Court’s decision comes on the heels of the United States Supreme Court’s unanimous decision in American Hospital Association v. Becerra, 142 S. Ct ...
The D.C. Circuit recently rejected a qui tam relator’s attempt to dodge the FCA’s first-to-file bar by amending his complaint. United States ex rel. Shea v. Cellco P’ship, 863 F.3d 923 (D.C. Cir. 2017). The panel’s correct interpretation of the first-to-file bar stymies relators’ ability to keep copycat FCA suits in court. The relator, a telecommunications industry consultant, filed a qui tam suit against Verizon Communications, Inc. in 2007 ...
In a split decision on September 20 in Singletary v. Howard University, the D.C. Circuit reversed the dismissal of an FCA retaliation suit brought by a former Howard University veterinarian whose contract was cut short after she warned of unsafe conditions for animals in the medical school’s federally funded laboratories. No. 18-7158, 2019 U.S. App. LEXIS 28468 (Sept. 20, 2019) ...
The Health Insurance Portability and Accountability Act (“HIPAA”) contains minimum security standards that Covered Entities and Business Associates must employ to safeguard protected health information (“PHI”). As part of HIPAA’s security standards, Business Associates are obligated to report all security incidents to the Covered Entity ...
