Jeff Wurzburg (US)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Healthcare and Coronavirus Testing Funding in the $484 Billion Relief Package

On Tuesday, April 21, the U.S. Senate approved a $484 billion coronavirus relief package aimed at reviving the depleted loan program for small businesses and providing funds for hospitals and coronavirus testing.  The House of Representatives is expected to vote on the legislation as soon as Thursday morning. On top of the $100 billion allotted … Continue reading

COVID-19 Update: Texas Medical Board Adopts Emergency Rule Regarding Elective Surgeries

The Texas Medical Board (“TMB”) has adopted an emergency rule based on Governor Greg Abbott’s April 17, 2020 Executive Order, which permits certain elective procedures beginning at 11:59 p.m. on April 21, 2020.  The emergency rule incorporates a violation of the Executive Order to the definition of “Unprofessional and Dishonorable Conduct” under 22 Texas Administrative … Continue reading

COVID-19 Update: CMS Issues Recommendations for Re-Opening Facilities for Non-Emergent Care

On Sunday April 19, 2020, CMS issued guidance for permitting non-emergent, non-COVID-19 healthcare in states that have passed the Gating Criteria provided in the Guidelines for Opening Up America Again.  CMS reiterated support for telehealth, stating that “[m]aximum use of all telehealth modalities is strongly recommended.” Decisions should be” consistent with public health information and … Continue reading

COVID-19 Update: Provider Relief Fund Attestation Portal Opens

On April 10, 2020, CMS made $30 billion in aggregate Public Health and Social Services Emergency Fund (“Relief Fund”) payments to providers, with each provider receiving a proportionate distribution based on how much that provider billed Medicare fee-for-service in 2019.  Providers receiving Relief Fund payments authorized by the CARES Act must submit an attestation to … Continue reading

COVID-19 Update: American Medical Association and Other Physician Organizations Request Liability Protections

In an April 15, 2020 letter to Congress, the American Medical Association and other physician organizations requested additional protection from “increased liability risk facing physicians and other clinicians” responding to the COVID-19 pandemic.   The organizations request liability protections broader than the protections provided to health care volunteers in section 3215 of the CARES Act.  The … Continue reading

COVID-19 Update: CMS releases additional guidance to states on how the FFCRA and CARES Act provisions apply to Medicaid and CHIP

On Monday, April 13, 2020, CMS released an updated FAQ on the enhanced Federal Medical Assistance Program (FMAP) and the Families First Coronavirus Response Act (FFCRA) implementation, as well as new guidance on CMS’ Coronavirus Aid, Relief, and Economic Security (CARES) Act implementation. In these new resources, CMS explains the following changes, among others, to … Continue reading

COVID-19 Update: CMS Issues Additional Waivers to Assist Providers

The Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules to boost frontline medical staff at healthcare facilities during the COVID-19 pandemic.  The new waivers expand on the workforce flexibilities announced by CMS on March 30, 2020 (previously covered by the HL Pulse here).  The new waivers include: Physicians in Critical … Continue reading

COVID-19 Update: HHS Releases Details of CARES Act Provider Relief Fund

On Friday morning April 10, the U.S. Department of Health and Human Services (“HHS”) released details regarding the first $30 billion in payments under the CARES Act.  The CARES Act provides a total of $100 billion in relief funds to providers “to support healthcare-related expenses or lost revenue attributable to COVID-19 and to ensure uninsured … Continue reading

COVID-19 Update: New CDC Guidance on Critical Workforce

On April 8, 2020, the U.S. Centers for Disease Control (“CDC”) issued updated guidance for critical infrastructure workers returning to work.  Previously, the CDC had provided that an individual exposed to the coronavirus should self-quarantine for fourteen days.  The CDC now recommends that critical infrastructure workers “may be permitted to continue to work following a … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020.  HL Pulse summary is available here.  Specifically, the Executive Order … Continue reading
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