Topic: General

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 3, 2020 Posted in Coronavirus, General, News from DC, Regulatory

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 Issues Wide Ranging Blanket Waivers to Assist Providers

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US), Joseph Keillor (US) and Hayley White (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers will remain in effect until the end of the emergency declaration. CMS issued a summary … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients. However, this “strategy should only be … Continue reading

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

By Frances Morgan (US) and Thomas Dowdell (US) on March 30, 2020 Posted in Coronavirus, General, News from DC

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

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, News from DC

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, News from DC

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

AHA seeks clarification from HHS regarding EMTALA and HIPAA waivers

By Thomas Dowdell (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, Regulatory

In a letter dated March 25, 2020, the American Hospital Association (AHA) has requested that the U.S. Department of Health & Human Services (HHS) consider clarification for waivers relating to the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA). HHS recently published two waivers specific to EMTALA … Continue reading

COVID-19 Update: HHS Issues Notice of Designation to Prevent Hoarding and OIG launches COVID-19 Portal

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, Regulatory

On March 25, in response to President Trump’s Executive Order, HHS issued a Notice of Designation a list of health and medical resources necessary to respond to COVID-19 that are necessary to combat the spread of the disease. The Defense Production Act “prohibits any person from accumulating designated materials (1) in excess of the reasonable … Continue reading

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

By Hayley White (US), Jeff Wurzburg (US), Thomas Dowdell (US) and Yvonne Puig (US) on March 25, 2020 Posted in Coronavirus, General, News from DC

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 24, 2020 Posted in Coronavirus, General, News from DC

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

By Mark Faccenda (US) and Frances Morgan (US) on March 24, 2020 Posted in Coronavirus, General, News from DC

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

CMS Announces Relief on Quality Reporting Program Measures Due to COVID-19 (Coronavirus)

By Thomas Dowdell (US), Frances Morgan (US) and Jeff Wurzburg (US) on March 24, 2020 Posted in Coronavirus, General, Regulatory

On March 22, CMS announced that for providers participating in quality reporting programs the agency is granting extensions on reporting deadlines and allowing the omission of certain time periods for most program reporting. CMS released a programmatic chart explaining the relief granted considering the “extreme and uncontrollable circumstances” resulting from the COVID-19 pandemic. Of particular … Continue reading

COVID-19 (Coronavirus) Update: CMS Announces Targeted Plan for Facility Inspections – Infection Control and Immediate Jeopardy

By Thomas Dowdell (US) and Frances Morgan (US) on March 24, 2020 Posted in Coronavirus, General, Regulatory

On March 23rd, 2020, CMS announced a newly “enhanced, focused inspection process” to be implemented nationally in light of the COVID-19 (coronavirus) pandemic and released guidance to state survey agency directors. Standard and Revisit Inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices will not be … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

By Yvonne Puig (US), Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on March 23, 2020 Posted in Coronavirus, FDA & Food Safety, General

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic. FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

COVID-19 Update: HHS Declaration Provides Liability Immunity Related to Certain COVID-19 Countermeasures

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

The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency. On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures … Continue reading

COVID-19 Update: Phase Three Stimulus Legislation Stalls on Sunday Afternoon

By Thomas Dowdell (US) and Rachel Park (US) on March 22, 2020 Posted in Coronavirus, General, News from DC

The Phase Three Senate Republican stimulus legislation released Sunday afternoon (March 22), H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), would provide aid for small businesses, industries and families impacted by the COVID-19 (coronavirus) pandemic, including direct cash payments for Americans, as well as $75 billion for coronavirus response payments to … Continue reading

Coronavirus | COVID-19 Update: CMS issues guidance to all PACE Organizations to implement policies and procedures to prevent the spread of COVID-19

By Yvonne Puig (US), Daphne Calderon (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on March 19, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, March 17, 2020, the Centers for Medicare & Medicaid Services (CMS) released guidance to all Programs of All-Inclusive Care for the Elderly (PACE) Organizations (POs) on policies and standard practices to follow in regards to the COVID-19 public health emergency.… Continue reading

COVID-19 Update: Trump administration expands access to telehealth services for Medicare beneficiaries to combat COVID-19

By Yvonne Puig (US), Daphne Calderon (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on March 17, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, March 17, 2020, the Trump administration announced that it will immediately expand access to telehealth services for all Medicare beneficiaries during the COVID-19 outbreak. In coordination with this announcement, the Office for Civil Rights at the Department of Health & Human Services (HHS) released a notification stating that HHS has temporarily suspended certain … Continue reading

COVID-19 Update: CMS Approves First Section 1135 Waiver

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 17, 2020 Posted in Coronavirus, General, News from DC

Following President Trump’s declaration of a national emergency on March 13, 2020, CMS approved the first Section 1135 waiver related to Medicaid on Monday. The State of Florida received permission to eliminate the limits on instances of care furnished and how many participants receive care from an out-of-state provider for the duration of the 1135 … Continue reading

COVID-19 Update: Coronavirus Designated a Pandemic by WHO

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 11, 2020 Posted in Coronavirus, General

On Wednesday the World Health Organization declared COVID-19 a pandemic. WHO Director-General Tedros Adhanom Ghebreyesus stated that “In the days and weeks ahead, we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher.” In a hearing before the House Oversight and Reform Committee Dr. … Continue reading

COVID-19 Update: Telehealth flexibility and CMS Provides Additional Information

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 9, 2020 Posted in Coronavirus, General

On Sunday, March 8, 2020, the known cases of coronavirus in the United States surpassed 500. Cases have been identified in more than 30 states and the District of Columbia. Worldwide there are 109,835 confirmed cases, resulting in 3,803 deaths. Eight states have declared states of emergency: Washington, Florida, California, New York, Kentucky, Maryland, Utah, … Continue reading

COVID-19 Update: CMS Releases Guidance for Hospitals and Nursing Homes

By Yvonne Puig (US), Thomas Dowdell (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 5, 2020 Posted in Coronavirus, General

On Wednesday March 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released three guidance documents for health care providers relating to the coronavirus. Worldwide there have been 96,888 confirmed cases, resulting in 3,305 fatalities, including 11 deaths in the United States. In a press release, CMS stated that the actions taken were “focused … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

By Rachel Park (US), Jeff Wurzburg (US) and Mark Faccenda (US) on March 3, 2020 Posted in FDA & Food Safety, General

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020. The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading