Topic: General

COVID-19 Update: CDC Updates Travel Guidelines While New Double Variant Emerges

The U.S. Centers for Disease Control and Prevention (“CDC”) has updated its travel guidelines, advising that there is low risk for fully vaccinated individuals to travel domestically. The CDC further provides that for fully vaccinated individuals COVID-19 testing or a quarantine period is unnecessary following travel. When traveling internationally, the CDC states that testing is … Continue reading

Litigation trends in life sciences and pharmaceuticals: What you need to know

By Allison Lange Garrison (US) on April 5, 2021 Posted in General

A team of Norton Rose Fulbright pharma and medical-device litigators recently presented to the Life Sciences and Healthcare Spring Webinar Series on “Pharma Delivers: Now What?” Pharmaceutical companies delivered pandemic-ending vaccines, and are rewarded with an increasingly positive public reputation. The presenters forecasted how this public-opinion bump might impact future litigation, and more broadly discussed … Continue reading

Xavier Becerra Confirmed as HHS Secretary – Implications for Health System “all-or-nothing” clauses

By Marc Collier (US), Vic Domen (US) and Jeff Wurzburg (US) on March 19, 2021 Posted in General, News from DC

Xavier Becerra was confirmed as U.S. Secretary for Health and Human Services (“HHS”) on March 18, 2021. While the parameters of the Biden administration’s antitrust policy priorities and objectives are not yet clear, a groundbreaking lawsuit brought by Xavier Becerra while Attorney General of California offers important insight and warrants a close reexamination of managed … Continue reading

Biden Administration Withdraws Work Requirement Approvals in Arkansas and New Hampshire

By Jeff Wurzburg (US) and Mary Ytterberg (US) on March 19, 2021 Posted in General, Regulatory

Medicaid is the largest health coverage source in the United States, covering approximately 70 million individuals including children, pregnant women, people with disabilities, elderly adults, and in states that have expanded their Medicaid programs under the Affordable Care Act, low-income adults without children with household income up to 138%. One of the unique designs of … Continue reading

COVID-19 Update: CDC Updates School Guidelines

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 19, 2021 Posted in Coronavirus, General

On March 19, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) released updated guidelines for K-12 schools that is anticipated to facilitate the reopening of schools across the country. The CDC states that “[o]pening schools for in-person learning as safely and quickly as possible, and keeping them open, is important given the many … Continue reading

COVID-19 Update: CDC Releases Guidance for Vaccinated Individuals

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 8, 2021 Posted in Coronavirus, General

Ever since the U.S. declaration of a public health emergency on March 13, 2020, Americans have wondered what life would look like if and when a vaccine was developed. In December, the first vaccine was administered in the U.S. On March 8, 2021, the positive momentum accelerated when the U.S. Centers for Disease Control and … Continue reading

COVID-19 Update: CDC Increasing Sequencing for Virus Variants

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 26, 2021 Posted in Coronavirus, General

The Biden Administration recently announced additional funding to increase genomic sequencing of COVID-19 to 25,000 samples a week. In a recent article in the Journal for the American Medical Association, U.S. Centers for Disease Control and Prevention (“CDC”) Director Rochelle Walensky and Dr. Anthony Fauci of the U.S. National Institute of Allergy and Infectious Diseases … Continue reading

COVID-19 Update: CDC Recommends Double Masking and Changes Quarantine Guidelines

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 11, 2021 Posted in Coronavirus, General

Two recent updates in COVID-19 guidelines from the U.S. Centers for Disease Control and Prevention (“CDC”) demonstrate the challenges faced by public health officials to appreciate and incorporate the ever-changing science surrounding the global pandemic. New guidance from the CDC recommends wearing a cloth mask over a medical mask. The CDC’s guidelines recommend: Choosing a … Continue reading

The Joint Commission’s First Special Edition Sentinel Event Alert

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on February 3, 2021 Posted in Coronavirus, General, Regulatory

Recognizing its unique position to understand and shed light on the collective experience of America’s health care organizations during the COVID-19 pandemic, on February 2, 2021, the Joint Commission published the first in its series of special edition Sentinel Event Alerts. The special edition publication addresses COVID-19-specific concerns and comments that the Joint Commission’s Office … Continue reading

COVID-19 Update: Biden Executive Order Creates Special Enrollment Period

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 1, 2021 Posted in Coronavirus, General, News from DC

On January 28, 2021, President Biden issued an Executive Order entitled Executive Order on Strengthening Medicaid and the Affordable Care Act (“Executive Order”). “In light of the exceptional circumstances caused by the ongoing COVID-19 pandemic”, the Executive Order creates a special enrollment period in states that operate Federally-facilitated exchanges from February 15, 2021 – May … Continue reading

COVID-19 Update: HHS OGC Issues PREP Act Advisory Opinion

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 12, 2021 Posted in General

On January 8, 2021, the U.S. Department of Health and Human Services released Advisory Opinion 22-01 entitled On The Public Readiness and Emergency Preparedness Act Scope of Preemption Provision. The Advisory Opinion addresses the Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of … Continue reading

HHS Issues Final Rule Requiring Retrospective Review of Regulations

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 11, 2021 Posted in General, Regulatory

On Friday, January 8, 2021, the Department of Health and Human Services (“HHS”) released a final rule that would provide HHS with five years to review existing regulations that are more than ten years old, subject to certain exceptions, to determine if each regulation is still necessary. HHS will be permitted to extend this deadline … Continue reading

COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 8, 2021 Posted in Coronavirus, General, News from DC

On January 6, 2021 U.S. Department of Health and Human Services Secretary Alex Azar renewed the Public Health Emergency declaration, effective January 21, 2021. In a tweet, Secretary Azar announced the renewal and stated that “[o]ur work to combat the virus will continue, as will our work to ensure a peaceful and orderly transition.” The … Continue reading

COVID-19 Update: Healthcare provisions (Including Medicare GME Revisions) in the Consolidated Appropriations Act, 2021

By Mark Faccenda (US), Andrew Roth (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 4, 2021 Posted in Coronavirus, General, News from DC

On December 27, 2020, President Trump signed into law the fourth round of COVID-19 emergency relief that passed both the U.S. Senate and the U.S. House of Representatives. The Consolidated Appropriations Act, 2021 (“Act”) includes approximately $900 billion in pandemic relief and is reportedly the longest bill (5,593 pages) to be passed in Congress’s history. … Continue reading

D.C. Circuit Upholds CMS Price Transparency Rule

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 29, 2020 Posted in General, News from DC

On December 29, 2020, three days before the implementation date, the U.S. Court of Appeals for the D.C. Circuit upheld the Centers for Medicare & Medicaid Services (“CMS”) price transparency final rule. Beginning January 1, 2021, hospitals will be required to make public their standard charges for 300 shoppable services, including 70 services identified by … Continue reading

CMS releases special alert on monitoring hospital compliance with price transparency requirements

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 21, 2020 Posted in General, News from DC, Regulatory

On Friday, December 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a special alert to remind hospitals that the Hospital Price Transparency final rule (“final rule”) requirements are effective starting January 1, 2021 and that CMS will monitor a “sample of hospitals” when the final rule goes into effect to determine compliance … Continue reading

COVID-19 Update: First Person Receives COVID-19 Vaccine in U.S.

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

Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little after 9:00 a.m. ET. This happened just three days after the U.S. Food and Drug Administration … Continue reading

CMS releases proposed interoperability rule to improve prior authorizations and the electronic exchange of healthcare data

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on December 14, 2020 Posted in General, News from DC, Regulatory

On December 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the prior authorization process and to add new requirements for state Medicaid and Children’s Health Insurance Program (“CHIP”) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges … Continue reading

CMS Publishes 2021 Hospital OPPS and ASC Final Rule

By Jeff Wurzburg (US) and Thomas Dowdell (US) on December 4, 2020 Posted in General, Regulatory

The Centers for Medicare & Medicaid Services (“CMS”) has published the Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) final rule for CY 2021. CMS finalized an annual increase OPPS and ASC rates of 2.4 percent for CY 2021, based on a 2.4 percent market basket update and without a cut for … Continue reading

CMS Announces New Acute Hospital Care At Home Program and Additional Flexibility in the Hospitals Without Walls Program

By Thomas Dowdell (US) on November 25, 2020 Posted in General, News from DC, Regulatory

On Wednesday, November 25, the Centers for Medicare & Medicaid Services (CMS) announced its new Acute Hospital at Home program and additional regulatory flexibility in its Hospitals Without Walls program. The Acute Hospital Care at Home program is for beneficiaries who require acute inpatient admission to a hospital and who require at a minimum daily … Continue reading

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

By Joseph Keillor (US) and Jeff Wurzburg (US) on November 23, 2020 Posted in Enforcement, General, News from DC, Regulatory

In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … Continue reading

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on November 20, 2020 Posted in Coronavirus, FDA & Food Safety, General

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