Tag archives: COVID-19

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

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

COVID-19 Update: World Health Organization Warns of Dangerous Phase

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 22, 2020 Posted in Coronavirus, General, International

During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.” June 22, 2020 saw the largest single day spike in cases, with 183,020 new cases worldwide. In the … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 15, 2020 Posted in Coronavirus, FDA & Food Safety, General

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ). The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: CDC Issues Guidelines for Events and Gatherings

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 15, 2020 Posted in Coronavirus, General, News from DC

On Friday June 12 the U.S. Centers for Disease Control and Prevention (CDC) published guidelines for events and gatherings ranging from lowest risk (virtual-only) to highest risk (large, in-person, where difficult to space at least six feet apart and attendees come from other areas). The guidelines arrive at a time when cities and states have … Continue reading

Arbitrating disputes in the pharmaceutical, life sciences and healthcare sector in the era of the COVID-19 pandemic

By Martin Valasek (CA), Jordana Sanft (CA), Randy Sutton (CA) and Brian R. Daley (CA) on June 11, 2020 Posted in Coronavirus, General, International

Introduction A signature feature of the last several months has been the scramble for masks, shields and gowns – personal protective equipment (PPE) – for doctors, nurses and other care workers. Governments have been focused on ensuring that health authorities, both public and private, have a sufficient supply of essential medical equipment (such as PPE … Continue reading

COVID-19 Update: CMS releases guide encouraging patients to seek in-person healthcare

By Thomas Dowdell (US) and Hayley White (US) on June 11, 2020 Posted in Coronavirus, Regulatory

On Tuesday, June 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a guide for patients who are considering their in-person care options following certain healthcare facilities re-opening for all medical services. As COVID-19 cases decline in some areas of the country, CMS created this guide to give patients recommendations, and to help … Continue reading

COVID-19 Update: The Joint Commission to Resume Hospital Surveys

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 10, 2020 Posted in Coronavirus, General, Regulatory

The Joint Commission (TJC) is resuming regular surveys and reviews after suspending them at the outset of the COVID-19 pandemic. Safety will be “the first and foremost priority” as surveys and reviews are resumed and the survey’s will “assess the impact that the coronavirus pandemic had on their operations and their current state.” The surveys … Continue reading

FTC Submits Comment Supporting Telehealth Provisions in CMS Interim Final Rule

By Amanda Wait (US), Jeff Wurzburg (US) and Rachel Park (US) on June 8, 2020 Posted in Coronavirus, General, Regulatory

On June 2, 2020, the staffs of the Federal Trade Commission’s (FTC) Office of Policy Planning, Bureau of Economics, Bureau of Competition and Office of the General Counsel submitted a comment to the Centers for Medicare & Medicaid Services (CMS) on its Interim Final Rule regarding policy and regulatory revisions in response to the COVID-19 … Continue reading

CMS Announces COVID-19 Adjustments for CMMI Models

By Jeff Wurzburg (US) and Thomas Dowdell (US) on June 3, 2020 Posted in Coronavirus, General, News from DC

On June 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced adjustments to the Center for Medicare and Medicaid Innovation (“CMMI”) models in light of the COVID-19 public health emergency. Despite the accommodations being provided, Administrator Verma praised value-based incentives in a Health Affairs blog post, stating that “[t]hese models are … Continue reading

COVID-19 Update: CDC Releases Interim Guidelines on Antibody Testing

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 27, 2020 Posted in Coronavirus, General, News from DC

On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests. The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.” The interim guidelines specifically address: Development of Antibodies … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 21, 2020 Posted in Coronavirus, General, Regulatory

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations. The document, entitled CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again, builds upon the decision tools issued by the CDC last week. The … Continue reading

COVID-19 Update: CDC Releases Guidance for Reopening

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 14, 2020 Posted in Coronavirus, General, News from DC

On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities. The decision tools state that “[i]t is important to check with state and local health officials and other partners to determine the most appropriate actions while adjusting to meet the unique needs … Continue reading

CMS Issues FY 2021 Hospital IPPS and LTCH PPS Proposed Rule

By Thomas Dowdell (US) on May 13, 2020 Posted in Coronavirus, General, Regulatory

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. Under the proposed rule Medicare IPPS payment rates would increase an estimated net 3.1 percent for hospitals that successfully … Continue reading

COVID-19 Update: FBI Warns of Hackers Targeting COVID-19 Research

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 13, 2020 Posted in Coronavirus, General, News from DC

In a Public Service Announcement issued May 13, 2020, the U.S. Federal Bureau of Investigation (“FBI”) and Cybersecurity and Infrastructure and Security Agency (“CISA”) warned of the targeting and compromise of U.S. organizations conducting COVID-19 research. More specifically, the announcement warns that “actors have been observed attempting to identify and illicitly obtain valuable intellectual property … Continue reading

COVID-19 Update: U.S. and U.K. Issue Joint Alert Regarding COVID-19 Research Cyber Threat

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 6, 2020 Posted in Coronavirus, General, International

The U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency and the U.K.’s National Cyber Security Centre issued a joint alert on Tuesday that advanced persistent threat groups “are actively targeting organizations involved in both national and international COVID-19 responses.” This warning should be heeded by hospitals, health systems, pharmaceutical companies, and academic medical … Continue reading