Tag archives: COVID-19

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate. Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective. In addition to the effectiveness, … Continue reading

OSHA Releases Information on its Recent COVID-19 Related Enforcement Activity

By Kevin Mayer (US) on November 17, 2020 Posted in Coronavirus, General

On Friday, November 13, the United States Occupational Safety & Health Administration (“OSHA”) issued a news release on its recent enforcement activities for violations that are related to the coronavirus pandemic. More specifically, OSHA stated that it has issued 204 citations arising from inspections for COVID-19 violations and that this has resulted in proposed penalties … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on November 10, 2020 Posted in Coronavirus, FDA & Food Safety, General

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on November 4, 2020 Posted in Coronavirus, General, News from DC, Regulatory

On Wednesday, October 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”), with the Departments of Treasury and Labor, issued a fourth interim final rule (“IFR”) with comment period addressing the public health emergency (“PHE”). The policies in the IFR will become effective upon publication in the Federal Register. The IFR’s stated goal is … Continue reading

COVID-19 Update: CDC Updates Guidance on Public Transportation and Close Contacts

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 23, 2020 Posted in Coronavirus, General, News from DC

The U.S. Centers for Disease Control (“CDC”) continues to update COVID-19 guidance as more information is known about how the coronavirus spreads. On October 21, 2020, the CDC made a significant update to the definition of “close contact”. Individuals that have spent 15 cumulative minutes within six feet of an infected individual during a 24-hour … Continue reading

COVID-19 Update: HHS Renews COVID-19 Public Health Emergency Declaration

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on October 12, 2020 Posted in Coronavirus, General, News from DC

On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic. This renewal will become effective on October 23, 2020 when the previous July 23 renewal was set to expire and will continue to January … Continue reading

COVID-19: OSHA Updates and Reporting Requirements

By Yvonne Puig (US), Kevin Mayer (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 5, 2020 Posted in Coronavirus, News from DC, Regulatory

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19. Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic. OSHA recently updated its COVID-19 … Continue reading

Norton Rose Fulbright US LLP Leads Conversation with PE Leaders Re the Future of Healthcare

By Purvi Maniar (US) and Maxwell Karasek (US) on October 1, 2020 Posted in General

On September 22, 2020, Norton Rose Fulbright US LLP and Ernst & Young LLP held their 5th Annual Health Care Private Equity Conference. As with most other conferences this year, this event was hosted virtually. NRF Partner Warren J. Nimetz, led an insightful and lively discussion on the annual panel “What’s Hot and What’s Not” … Continue reading

COVID-19 Update: U.S. Surpasses 200,000 Fatalities; CDC Releases Holiday Guidelines

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on September 27, 2020 Posted in Coronavirus, General

This past week the United States surpassed the grim milestone of 200,000 COVID-19 deaths and seven million cases of COVID-19. The spread of the virus has altered the way we work, live, and play around the world and will soon touch on one of the most treasured times of the year, the holiday season. The … Continue reading

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on September 15, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on September 9, 2020 Posted in Coronavirus, FDA & Food Safety, General

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 28, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley White (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

COVID-19 Update: CMS Announces Resumption of Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … Continue reading

CMS Publishes CY 2021 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on August 7, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, August 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published the calendar year (“CY”) 2021 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System proposed rule. The proposed rule would increase hospital Medicare OPPS payment rates by 2.6 percent and ASC payment rates by 2.6 percent … Continue reading

COVID-19 Update: Trump Issues ‘Buy American’ Executive Order Related to Drugs

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 7, 2020 Posted in Coronavirus, General, News from DC

On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States. The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats … Continue reading

CMS Publishes CY 2021 Proposed Policy, Payment, and Quality Provision Changes to Medicare Physician Fee Schedule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Rachel Park (US) on August 5, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Monday, August 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2021 Physician Fee Schedule (PFS) proposed rule. We describe certain material provisions from the proposed rule below. Telehealth CMS proposes to add services to the Medicare telehealth list on a Category 1 basis. The additional services include group psychotherapy, … Continue reading

COVID-19 update: Trump issues Telehealth Executive Order

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in Coronavirus, Enforcement, News from DC

President Trump issued an Executive Order on August 3, 2020 that will continue the momentum for telehealth in rural areas.… Continue reading

COVID-19 Update: Senators Release Liability Protection Draft Legislation

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on July 31, 2020 Posted in Coronavirus, General, News from DC

On July 27, 2020, Senators Mitch McConnell (R-KY) and John Cornyn (R-TX) released the SAFE TO WORK Act (“the Act”). The Act was released as part of the Senate Republicans draft coronavirus legislation, the HEALS Act, which stands for Health; Economic Assistance; Liability protection; and Schools. The Act seeks to limit liability for healthcare providers … Continue reading

President Trump unveils executive orders on lowering drug prices

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 30, 2020 Posted in Coronavirus, Enforcement, General, News from DC

On Friday, July 24, 2020, President Trump issued three executive orders, and announced a potential fourth executive order, with the stated intention of lowering the cost of prescription drugs in the United States. The general consensus among legal commentators is that the executive orders are not self-executing and implementation of the policies therein will, therefore, … Continue reading

Court of Appeals Upholds HHS Site-Neutral Payment Cuts to Off-Campus Provider Based Departments

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 20, 2020 Posted in Coronavirus, Enforcement, General

On Friday, July 17, 2020, the Court of Appeals for the District of Columbia found in favor of the U.S. Department of Health and Human Services (“HHS”) by holding that Medicare Part B payment cuts to certain services provided to Medicare beneficiaries in off-campus provider-based departments (“PBDs”) are within the agency’s statutory authority. More specifically, … Continue reading

CMS Administrator Publishes Blog Post on Expansion of Medicare Telehealth Services

By Thomas Dowdell (US), Jeff Wurzburg (US) and Rachel Park (US) on July 17, 2020 Posted in Coronavirus, General, Regulatory

On Wednesday, July 15, 2020, Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, published a blog post on the Health Affairs Blog discussing CMS’ efforts to expand telehealth for Medicare beneficiaries during the COVID-19 pandemic and reviewing the potential of adopting some flexibilities as permanent measures. Historically Medicare has covered telehealth … Continue reading

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on July 14, 2020 Posted in Coronavirus, General, Regulatory

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20. Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.” To … Continue reading

COVID-19 Update: The Joint Commission Resumes Laboratory Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 29, 2020 Posted in Coronavirus, General

In a special LabFocus The Joint Commission revealed they have resumed some laboratory survey activities. TJC stated that “[a]ccount executives are contacting organizations due for a survey to assess the impact that the coronavirus pandemic had on their operations and their current state.” To determine which organizations will be surveyed, TJC is looking at “a … Continue reading