Topic: News from DC

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

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

CMS Announces COVID-19 Adjustments for CMMI Models

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

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

CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

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

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

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: 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: 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: 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

New Facility-Specific Guidance for Providers for COVID-19: Infection Control, Supply Shortages, and Staff Management

On April 8, 2020, CMS issued follow up guidance to healthcare providers to address infection control for COVID-19 patients, including patient monitoring, isolation techniques, supply shortage guidance, and staff training to avoid infection. CMS intends this guidance to “empower hospitals and healthcare systems… by equipping providers and clinicians with clear guidance based on CDC recommendations.” … Continue reading

COVID-19 Update: CDC Recommends Use of Cloth Face Coverings and President Issues Executive Order on PPE

On Friday April 3, the U.S. Centers for Disease Control (“CDC”) recommended “the wearing of cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission.”   The CDC provides citations for several studies finding that individuals with coronavirus may … Continue reading

COVID-19 Update: CDC Issues Guidance on Decontamination of FFR and President Trump Issues Executive Orders for Medical Equipment

Earlier this week the U.S. Centers for Disease Control (CDC) provided recommendations for the decontamination and reuse of filtering facepiece respirators (FFR).  The guidance states that a study found the coronavirus is able to survive for up to 72 hours on plastic, stainless steel, and cardboard.  The CDC provides that “decontamination and subsequent reuse of … Continue reading

COVID-19 update: CMS publishes fact sheet describing process for providers and suppliers seeking CARES Act Medicare accelerated and advance payments

On March 28, 2020, CMS released guidance related to the expanded accelerated and advance payments provided under the Coronavirus Aid, Relief, and Economic Security (CARES) Act signed into law by President Trump on March 27. These payments are typically available when there is a disruption in claims submission or claims processing, and are offered in … Continue reading

COVID-19 Update: Senate Unanimously Passes Emergency Stimulus Package

The United States Senate has passed a $2 trillion phase three emergency package, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  The Senate approved the CARES Act on a unanimous vote of 96-0, with three Senators in self-quarantine and another returning home out of an abundance of caution.  The CARES Act, assuming it … Continue reading

COVID-19 Update: New Model for Allocating Hospital Resources Released/Payors Strengthening COVID-19 Coverage

The spread of COVID-19 in the United States is requiring providers to consider difficult questions regarding resource allocation.   On March 26, 2020 Dr. Douglas White of the University of Pittsburgh Department of Critical Care Medicine and Dr. Scott Halpern of the University of Pennsylvania Perelman School of Medicine released Allocation of Scarce Critical Resources During … Continue reading

COVID-19 Update: CDC publishes criteria for when healthcare professionals with confirmed and suspected COVID-19 can return to work

On Tuesday, March 24, 2020, the Centers for Disease Control and Prevention (CDC) issued interim guidance on criteria that can be used to determine whether a healthcare professional with a confirmed or suspected case of COVID-19 should return to work. The CDC states that this criteria can be further “adapted by state and local health … Continue reading

COVID-19 Update: President Trump Issues Executive Order on Hoarding

On March 23, 2020 President Trump signed an Executive Order directing the Secretary of HHS, under the authority of the Defense Production Act, to “prevent hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States.”  It also delegates to the Secretary of HHS the: [A]uthority to prescribe … Continue reading

Update to Prior CMS Action: CMS Approves 11 New Medicaid Section 1135 Waivers; 13 States Total

On March 13, 2020, following President Trump’s declaration of a national emergency in response to the COVID-19 pandemic, CMS announced its approval of the first Section 1135 Waiver aimed at addressing the spread of COVID-19 (Coronavirus) in Florida. On March 19, CMS granted a Section 1135 Waiver to deal with the COVID-19 outbreak in Washington … Continue reading

Senate COVID-19 (Coronavirus) Stimulus Legislation Stalls, House Democrats Introduce Competing Bill

On Monday evening, March 23, the Senate COVID-19 (coronavirus) stimulus package remained stalled.  A procedural vote to advance the Senate bill Monday afternoon failed and negotiations remain ongoing. House Speaker Nancy Pelosi announced a Democratic coronavirus stimulus plan in response to the Senate bill including more robust relief for individuals and providers and more targeted … Continue reading
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