Topic: General

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: 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

CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

By Andrew Roth (US) and Thomas Dowdell (US) on May 20, 2020 Posted in General, News from DC, 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. We previously reported on the hospital IPPS and LTCH PPS proposed changes. See link here . In this rulemaking, … 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

U.S. Supreme Court Rules that the Federal Government “Shall” Pay Health Insurers $12 Billion Under the Risk Corridors Program

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on May 6, 2020 Posted in Enforcement, General, News from DC

On Monday, April 27, 2020, the U.S. Supreme Court ruled, in an 8-1 decision, that the federal government is required to pay health insurers $12 billion under the Patient Protection and Affordable Care Act’s (ACA) risk corridors program. Background of the Case Congress in the ACA created three premium stabilization programs to support insurers during … Continue reading

COVID-19 Update: Highly-Impacted and Rural Hospital Distribution Imminent

By Jeff Wurzburg (US) and Frances Morgan (US) on May 3, 2020 Posted in Coronavirus, General

On the evening of May 1, 2020, HHS announced that it will distribute an additional $22 billion in payments from the Provider Relief Fund to hospitals with high volumes of COVID-19 patients ($12 billion) and rural hospitals ($10 billion) in the coming days. Qualifying hospitals will receive funds via direct deposit and will likely be … Continue reading

COVID-19 Update: HRSA holds a webinar on its COVID-19 Uninsured Program Portal

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on April 30, 2020 Posted in Coronavirus, General

On Thursday, April 30, 2020, the Health Resources and Services Administration (HRSA) held a webinar on its COVID-19 Uninsured Program Portal. On the webinar, HRSA and UnitedHealth Group employees explained that providers can begin using the Portal to be reimbursed for COVID-19 testing or treatment that has been provided to uninsured individuals in the U.S. … Continue reading

CMS Issues Second Round of Regulatory Waivers and Rule Changes

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 30, 2020 Posted in Coronavirus, General, Regulatory

Today, the Centers for Medicare & Medicaid Services (CMS) released an additional round of regulatory waivers and rule changes to support the healthcare system during the COVID-19 pandemic. The changes include new rules to expand COVID-19 diagnostic testing, increase care capacity and the healthcare workforce, and further promote telehealth services. Medicare no longer requires an … Continue reading

CMS Pauses Accelerated and Advanced Payments Programs

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 27, 2020 Posted in Coronavirus, General, Regulatory

CMS announced on Sunday, April 26, that it is suspending payments under the Advanced Payments Program to Part B suppliers immediately and reevaluating payment amounts under the Accelerated Payment Program. The Accelerated and Advanced Payments Programs enable Medicare providers and suppliers to receive advance Medicare payments and address cash flow issues during a disruption in … Continue reading

COVID-19 update: WHO urges cautions on immunity passports

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

As countries around the world seek creative policy solutions to permit the opening of their economies, the World Health Organization (“WHO”) released a Scientific Brief on April 24, 2020 finding that “[t]here is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.” The WHO is … Continue reading

COVID-19 Update: Senate Committee Announces “Aggressive Oversight” of Small Business Paycheck Protection Program loans

By Jeff Wurzburg (US) and Hayley White (US) on April 23, 2020 Posted in Coronavirus, General, News from DC

On Monday, April 20, 2020, Senator Marco Rubio (R-FL) announced, in his role as Chairman of the Committee on Small Business and Entrepreneurship, that “the Committee would conduct aggressive oversight” of loans already made pursuant to the Paycheck Protection Program (PPP). Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the PPP authorizes qualified … Continue reading

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

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

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here). The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading

HHS Releases Information on Remaining CARES Act Provider Relief Fund Payments

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on April 22, 2020 Posted in Coronavirus, General, News from DC

On April 21, 2020, the U.S. Department of Health and Human Service (“HHS”) announced how the remaining $70 billion of CARES Act funds in the Public Health and Social Services Emergency Fund (“Relief Fund”) will be distributed. HHS explained that $50 billion of the Relief Fund is allocated for general distribution. Between April 10 and … Continue reading