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COVID-19: Entry into the Emirates of Dubai and Abu Dhabi
Afridi & Angell, September 2020

On 12 September 2020, the UAE Ministry of Health and Prevention (MoHAP) reported 1007 new COVID-19 cases in the UAE. With the number of cases rising both within the UAE and in most other countries, the UAE government has reiterated the importance of adhering to preventive guidelines and has further placed safeguards, particularly in Abu Dhabi, to ensure that those traveling to the UAE are confined to prevent the transmission of the virus...

Long-Term Care Facility COVID-19 Testing Requirements and Revised COVID-19 Focused Survey Tool
Hanson Bridgett LLP, September 2020

Key Points On Aug. 25, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with a comment period (IFC) establishing new Long-Term Care Facility COVID-19 Testing Requirements for Staff and Residents. CMS has added 42 CFR §483.80(h), which requires that the facility test all residents and staff for COVID-19. Noncompliance related to this new requirement will be cited at new tag F886...

DOJ Aims Scrutiny at Lab Testing Space During COVID-19
Bradley Arant Boult Cummings LLP, August 2020

The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers...

The Health System Growth Imperative Charting Opportunities During the Pandemic and Beyond
Waller, August 2020

Executive summary The COVID-19 pandemic has created significant challenges for smaller hospitals and health systems. It has presented significant challenges to smaller, less capitalized and otherwise distressed healthcare providers. In terms of operating performance, half of our country’s hospitals reported negative margins as Q1 of 2020...

Tennessee enacts COVID-19 Recovery Act
Waller, August 2020

Tennessee Governor Bill Lee has signed into law the Tennessee COVID-19 Recovery Act which provides liability protection from claims related to the COVID-19 pandemic. The Waller Government Relations team worked closely with the Tennessee Chamber of Commerce and Industry and various stakeholders in recent months to achieve passage of the Tennessee COVID-19 Recovery Act...

Skilled Nursing Facilities Face Enforcement Challenges in COVID-19 Environment
Bradley Arant Boult Cummings LLP, August 2020

Skilled nursing facilities have faced unprecedented challenges since the outbreak of the coronavirus pandemic. Individuals with many high-risk characteristics are the typical patients of these facilities. Add to this, necessarily close proximity of these patients, scarcity of personal protective equipment and shortage of testing common across the healthcare industry, and you have a perfect storm of increased risk with limited options for mitigation...

Senior Living Communities Eligible for PREP Act Protection
Hanson Bridgett LLP, August 2020

In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19...

First Circuit Decision Underlines Risk of Criminal HIPAA Enforcement
Buchalter, August 2020

On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators...

The Madrid Protocol is Finally on its Way
Deacons, August 2020

Did you know? The new Trade Marks (Amendment) Ordinance 2020 which came into effect on 19 June 2020 empowers the Registrar of Trade Marks to make the rules for implementing the long-awaited Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (the “Madrid Protocol”) in Hong Kong...

CMS Announces Initiative to Transform Rural Health
Waller, August 2020

A new reimbursement model intended to address healthcare access and availability in rural communities was introduced by The Centers for Medicare & Medicaid Services (CMS) Innovation Center. The Community Health Access and Rural Transformation (CHART) Model will “provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes,” according to CMS...

Physician Practice M&A: A Pandemic-Inspired 6-Step Checklist for Sellers
Waller, August 2020

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...

New York Federal District Judge Rejects Key Aspects of the Families First Coronavirus Response Act (FFCRA)
Hanson Bridgett LLP, August 2020

Key Points New York federal district court vacates the DOL’s “health care provider” definition in the DOL’s Final Rule implementing the Families First Coronavirus Response Act. The court also vacates the DOL’s employer consent requirement for intermittent leave and the “unable to work” requirement for receipt of leave benefits. The national impact of the decision is currently unknown as the DOL contemplates next steps...

Does the Cloud of Vaping-Related Injuries Portend a Storm of Litigation?
Bradley Arant Boult Cummings LLP, August 2020

Electronic cigarettes and vaping have been heralded by many as a safer alternative to smoking traditional cigarettes. An outbreak of illnesses last fall allegedly related to vaping, however, ignited public hysteria and will almost certainly lead to substantial mass tort litigation aimed at manufacturers of e-cigarette devices and vaping liquids...

Coronavirus Digest: Patents and Other Intellectual Property Rights
PLMJ, August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces to prepare a Digest on these issues that is continuously updated...

COVID-19 Related Healthcare Fraud and Anti-Kickback Enforcement Focuses on Laboratory Testing
Haynes and Boone, LLP, July 2020

While the U.S...

DOL Releases Updated FMLA Forms
Dinsmore & Shohl LLP, July 2020

The Department of Labor’s Wage and Hour Division (WHD) recently released streamlined forms employers may use to coordinate leave under the Family and Medical Leave Act (FMLA)...

The Department of Labor and Center for Disease Control Issue New Guidance Related to COVID-19
Dinsmore & Shohl LLP, July 2020

As workplaces continue to reopen, the U.S. Department of Labor (DOL) and Centers for Disease Control and Prevention (CDC) issued additional guidance addressing various return to work issues and leave under the Family and Medical Leave Act (FMLA) and Families First Coronavirus Response Act (FFCRA). The new DOL guidance, summarized below, appears on the DOL’s FFCRA Questions and Answers page...

Bracing for Increased Cannabis Enforcement Under Prop 65
Buchalter, July 2020

California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent...

HHS Commits to Release Reporting Requirements for Provider Relief Funds on August 17
Waller, July 2020

Since the Department of Health and Human Services (HHS) Provider Relief Funds (PRF) first started arriving in provider bank accounts on April 10, 2020, HHS has stated that it will issue additional guidance “soon” on mandatory reporting requirements on how use of funds must be reported. The PRF funds are among the funds Congress appropriated to reimburse eligible healthcare providers for healthcare-related expenses or lost revenues attributable to COVID-19...

FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines
Patterson Belknap Webb & Tyler LLP, July 2020

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline...

California Senate Passes Bill Granting the Attorney General Authority To Review Health Care Acquisitions and Changes of Control
Buchalter, July 2020

SB 977 was passed by the California Senate on June 26, 2020. If the bill is passed by the Assembly and becomes law, it will require health care systems, private equity groups, hedge funds, and academic medical centers to obtain advance approval by the California Attorney General for substantially all acquisitions or change of control transactions with health care facilities and providers...

One Week Left for Eligible Dental Providers to Apply for Provider Relief Funds
Dykema, July 2020

Eligible dental providers may now apply for Provider Relief Funds, but the deadline to do so, July 24, 2020, is quickly approaching. On July 10, 2020, the U.S. Department of Health and Human Services (“HHS”) announced an additional $4 billion in relief payments to healthcare providers and, notably, opened its provider portal to dental providers...

Digital Labelling of Medications
ALRUD Law Firm, July 2020

As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system...

California Appellate Court Affirms Medi-Cal’s Obligation To Pay FQHCs 100% Of Their Reasonable Costs
Hanson Bridgett LLP, July 2020

In a landmark victory for Federally-qualified health centers, a California Court of Appeal confirmed last October that federal and state law requires the State of California to pay FQHCs “100 percent” of their costs of furnishing core and other ambulatory services to Medi-Cal beneficiaries. (Tulare Pediatric Health Care Center v. State Department of Health Care Services (2nd Dist. 2019) 41 Cal.App.5th 163...

Medicare May Permanently Allow Some Home Health Visits to Occur via Telehealth but it Could Cost You
Waller, July 2020

The impacts of COVID-19 appear set to permanently expand telehealth and fundamentally transform how and where providers practice. Shortly after the start of the pandemic, CMS made major temporary federal policy changes in response to the pandemic, including expanding access to telehealth services for people with Medicare, such as home health visits, and reimbursement for additional services when furnished via telehealth...

 

 

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