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Coronavirus Disease 2019
Situation Updates and Resources

Links to News Updates and Critical Documents

United States Deadlines

Currently, the USPTO has not generally extended deadlines for filings or response due to COVID-1 -- cannot extend deadlines specified by law.

However, where communications with the USPTO are delayed due to COVID-19, and where the delay has resulted in a patent application being abandoned or a reexamination prosecution being terminated, the USPTO will waive fees to revive the application or reexamination, as long as any such request is made within two months of the USPTO’s notice of abandonment or termination.

 

International Deadlines

  • Brazil’s National Institute of Industrial Property has closed, with all deadlines extended to April 14, 2020;
  • Canada’s IP Office has extended all deadlines to April 1, 2020;
  • EPO has not changed the deadlines for patents at this time;
  • World Intellectual Property Organization, responsible for Patent Cooperation Treaty (“PCT”) applications, has stated that it will continue to process applications without changes to deadlines;
  • China’s National IP Administration has stated it will forego late fees for missed annuity payments for issued patents, where the delay is due to COVID-19;
  • Germany’s Patent and Trademark Office position is similar to that of the USPTO —it will consider COVID-19 issues with regard to deadlines to reestablish rights in patent cases, but cannot extend deadlines specified by law;
  • India’s Trademark Registry has suspended all hearings between March 17 and April 15, 2020; and
  • United Kingdom’s IP Office has stated that it will extend deadlines, grant extensions, and reinstate IP rights lost during the outbreak on a case-by-case basis
  • (Libya, Peru, Spain) have suspended operations indefinitely
  • Kuwait— suspended operations through March 26; 
  • Saudi Arabia— suspended operations through April 1; 
  • Argentina— suspended operations through April 3; 
  • Philippines— suspended operations through April 15, 2020.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850


 

 DATE:                   March 18, 2020

 TO:                        Medicare-Medicaid Plan in Rhode Island

 FROM:                  Lindsay P. Barnette Director, Models, Demonstrations and Analysis Group Medicare-Medicaid Coordination Office

 SUBJECT:            Rhode Island ICI Medicare-Medicaid Plan Flexibilities Related to Coronavirus Disease 2019 - COVID-19

 

COVID-19 presents new challenges for coordination of care and communication with those dually eligible older adults and people with disabilities enrolled in Medicare-Medicaid Plans (MMPs). We appreciate your ongoing commitment to the people we serve.

Many MMPs already taken steps to reduce the risks of COVID-19 transmission and maintain continuity of operations. To support those efforts, after consultation with our partners at the Rhode Island Executive Office of Health and Human Services (EOHHS), we are permitting the Rhode Island MMP to request to temporarily suspend or limit face-to-face care coordination activities required under the three-way contract (found in sections 2.6.2.3, 2.6.2.4, and Appendix K) between CMS, EOHHS, and the MMP. We will exercise our enforcement discretion related to the aforementioned contract provisions if the MMP (1) can substitute face-to-face interactions with other approved modalities for conducting care coordination activities, such as telephonic and telehealth, and (2) implements the use of informational telephonic scripts with COVID-19 education for all incoming enrollee calls, outbound telephonic welcome calls, and assessment/reassessment communications to mitigate risks of COVID-19. This flexibility is effective until the State of Emergency related to COVID-19 in Rhode Island has been lifted. CMS and EOHHS will consider extending this policy as conditions warrant.

The MMP can request this flexibility by emailing CMS (MMCOCapsModel@cms.hhs.gov) and EOHHS (via John.Neubauer@ohhs.ri.gov) a commitment to provide a concise written plan that describes how the MMP will:

  1. complete care coordination activities in lieu of face-to-face contact; and 
  2. implement the use of informational telephonic scripts with COVID-19-related education for incoming enrollee calls and outbound telephonic welcome calls and assessment and reassessment outreaches

In recognition of rapidly evolving local circumstances, the MMP may immediately take advantage of the flexibilities described here upon submission of their request, and we will use our enforcement discretion accordingly, as long as the MMP submits the concise written plan within seven (7) business days. All scripting and related materials should be consistent with guidance from the Rhode Island Department of Health (RIDOH) and federal health authorities. This plan should include, but not be limited to:

    Finally, notwithstanding the guidance discussed in this memo, the MMP should comply with any instructions issued by federal, state, or local public health officials related to COVID-19 response. We encourage the MMP to review previously issued guidance from CMS regarding obligations and permissible flexibilities related to disasters and emergencies.

    For more information on COVID-19 and CMS and CDC resources that MMPs can utilize for beneficiary outreach and education, please see:

    https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-

    Emergencies/Current-Emergencies-page https://www.cms.gov/newsroom https://www.cdc.gov/coronavirus/2019-ncov/about/index.html https://health.ri.gov/diseases/ncov2019/

    Governor Abbott has waived certain regulations and directed that the Texas Department of Insurance (TDI) issue an emergency rule, all relating to telemedicine care for patients with state-regulated insurance plans. The suspensions and emergency rule will require telemedicine visits for patients with state-regulated plans to be paid the same as in-office visits for insurance purposes. 

    Click here for link to the Governor's press release. 
    Press release
     
    CMS Takes Action Nationwide to Aggressively Respond to Coronavirus National Emergency
     
     

         

    The Trump Administration today announced aggressive actions and regulatory flexibilities to help healthcare providers and states respond to and contain the spread of 2019 Novel Coronavirus Disease (COVID-19). The Centers for Medicare & Medicaid Services (CMS) is taking these actions following President Trump’s declaration of a national emergency due to COVID-19 earlier today.

    “Following President Trump’s leadership during this health emergency, CMS is taking immediate steps to give our nation’s providers, healthcare facilities, and states maximum flexibility,” said CMS Administrator Seema Verma. “It is vital that federal requirements designed for periods of relative calm do not hinder measures needed in an emergency. The nationwide waivers we are activating today will be a godsend for those on the frontlines of the fight against this new virus.”

    The President’s declaration empowers the Secretary of Health and Human Services (HHS) to authorize CMS to take proactive steps through 1135 waivers and rapidly expand the Administration’s aggressive efforts against COVID-19 led by the White House Coronavirus Task Force. The HHS Secretary is authorized to waive certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) program requirements and conditions of participation under Section 1135 of the Social Security Act once the President declares an emergency through the Stafford Act or National Emergency Act, and the Secretary declares a Public Health Emergency (PHE). HHS Secretary Alex M. Azar issued a PHE on January 31, 2020. As a result of this authority, CMS will activate blanket waivers, which will ease certain requirements for impacted providers.

    These waivers will allow CMS to take several key administrative actions in response to the national emergency declaration:

    Waivers and Flexibilities for Hospitals and other Healthcare Facilities:  CMS will temporarily waive or modify certain Medicare, Medicaid, and CHIP requirements. CMS will also issue several blanket waivers, listed on the website below, and the CMS Regional Offices will review other provider-specific requests. These waivers provide continued access to care for beneficiaries. For more information on the waivers CMS has granted, visit: www.cms.gov/emergency.

    Provider Enrollment Flexibilities:  CMS will temporarily suspend certain Medicare enrollment screening requirements including site visits and fingerprinting for non-certified Part B suppliers, physicians and non-physician practitioners. In addition, CMS will allow licensed providers to render services outside their state of enrollment. CMS will also establish a toll-free hotline for providers to enroll and receive temporary Medicare billing privileges. 

    Flexibility and Relief for State Medicaid Agencies:  The national emergency declaration also enables CMS to grant state and territorial Medicaid agencies a wider range of flexibilities under section 1135 waivers. States and territories are now encouraged to assess their needs and request these available flexibilities, which are outlined in the Medicaid and CHIP Disaster Response Toolkit. Examples of flexibilities available to states under section 1135 waivers include the ability to permit out-of-state providers to render services, temporarily suspend certain provider enrollment and revalidation requirements to promote access to care, allow providers to provide care in alternative settings, waive prior authorization requirements, and temporarily suspend certain pre-admission and annual screenings for nursing home residents. For more information and to access the toolkit, visit: https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html.

    Suspension of Enforcement Activities:  CMS will temporarily suspend non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse.

    CMS Central Office and the Regional Offices hosted two webinars in 2018 regarding Emergency Preparedness (EP) requirements and provider expectations. One was an all-provider training on June 19, 2018 (over 3,000 providers participated) and the other an all-surveyor training on August 14, 2018. Both presentations covered the EP Final Rule, which included emergency power supply; 1135 waiver process, best practices and lessons learned from past disasters, helpful resources and more. Both webinars are available at https://surveyortraining.cms.hhs.gov/.

    CMS also compiled a list of Frequently Asked Questions (FAQs) and useful national emergency preparedness resources to assist state survey agencies (SAs), their state, tribal, regional, and local emergency management partners, and healthcare providers to develop effective and robust emergency plans and toolkits to assure compliance with the EP rules.  The tools can be located at:

    Survey & Certification Group Emergency Preparedness Regulation dated November 2016, Revised June 1, 2017: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html

    https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Templates-Checklists.html

    CMS Regional Offices have provided specific emergency preparedness information to Medicare providers and suppliers through meetings, dialogue and presentations. The regional offices also provide regular technical assistance in emergency preparedness to state agencies and staff, who, since November 2017, have been regularly surveying providers and suppliers for compliance with emergency preparedness regulations.   

    To find additional COVID-19 preparedness and response resources for the healthcare sector and the latest regarding HHS activities against the virus, please visit: https://www.cdc.gov/coronavirus/2019-ncov/index.html

    For more information about the Department of Health and Human Services’ PHE, please visit: https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus.html

    For a fact sheet on the regulatory flexibilities and other actions CMS is taking to help healthcare providers and states respond to and contain COVID-19, please visit: https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf

    These and earlier CMS actions in response to the COVID-19 virus, are part of the ongoing White House Coronavirus Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, click here www.coronavirus.gov. For information specific to CMS, please visit the Current Emergencies Website.

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    Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter CMS Administrator @SeemaCMS, @CMSgov, and @CMSgovPress.


    CDC Interim Guidance

    CDC recommends that for the next 8 weeks, organizers cancel or postpone in-person events that consist of 50 people or more throughout the U.S.

    Guidance as of 3/15/2020

    Large events and mass gatherings can contribute to the spread of COVID-19 in the United States via travelers who attend these events and introduce the virus to new communities. Examples of large events and mass gatherings include conferences, festivals, parades, concerts, sporting events, weddings, and other types of assemblies. These events can be planned not only by organizations and communities but also by individuals.

    Therefore, CDC, in accordance with its guidance for large events and mass gatherings, recommends that for the next 8 weeks, organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States.

    Events of any size should only be continued if they can be carried out with adherence to guidelines for protecting vulnerable populations, hand hygiene, and social distancing.  When feasible, organizers could modify events to be virtual.

    This recommendation does not apply to the day to day operation of organizations such as schools, institutes of higher learning, or businesses. This recommendation is made in an attempt to reduce introduction of the virus into new communities and to slow the spread of infection in communities already affected by the virus.  This recommendation is not intended to supersede the advice of local public health officials.

    President Trump Declares a National Emergency: Click here for the Proclamation

    New York State Can Now Authorize 28 Labs to Run Manual, Semi-Automated and Automated Testing: Click here for updates from the Office of the Governor

    Texas Governor Abbott Issues Disaster Proclamation for All Texas Counties: Situation Summary
    Click here for the Proclamation | Click here for the Press Conference Announcement

    • Currently 39 confirmed COVID-19 cases in Texas (excluding Lackland Air Force Base in San Antonio)
    • DSHS is the lead agency for Texas’ response 
    • Governor is holding daily calls with local health authorities 
    • 10 labs can do COVID-19 testing – for information go to dshs.texas.gov/coronavirus 
    • Have asked insurers to waive testing and telemedicine costs - 2 options for the uninsured
      • Local public health departments (little to no cost) 
      • Private labs (could be a cost) 
      • Call 211 to find your local provider 
    • Texas public labs can test 273 people a day 
    • Private labs are starting to step up
    • Clinical Pathology Laboratories can test several thousand per week 
    • San Antonio has opened the first drive-thru testing facility
    • Currently only for first responders and health workers, or those with a critical need 
    • Dallas and Austin will probably have drive-thru facilities in the next week or two 
    • State Disaster for all Counties in Texas
      • Authorizes the use of all government money 
      • Can fully utilize all personnel 
      • Allows for resources to be used across the state 
      • The OAG can go after price gouging 
      • The Governor can waive laws that hinder preparedness and treatment 
      • Restricts visitation to hospitals, daycares, nursing homes, prison, jails, or criminal justice facilities 
      • Facilitates telemedicine 
      • Provides flexible work and telework policies
    • Seeking waivers for school lunch programs to continue to provide meals if schools close
    • Local authorities should send the governor regulations that they think need to be waived 
    • The only local entity that would be affected by COVID-19 are hospital districts and they were not subject to having their rollback rate changed in the law
    • Other local jurisdictions' resources are not foreseeably going to be taxed right now for these reasons: Texas has already received millions of dollars from the federal government that will be parceled out to local communities for COVID-19 response; and Congress is continuing to work on additional programs that could provide even more funding.
    • No need to stockpile supplies or hoard – there is plenty for everyone
    • Template of a positive outcome: On February 7th, 90 patients from China arrived at Lackland, and they all recovered and have returned home
    • Governor: “There will be no unmet financial needs at the local level – we will see what happens.” 
    Health Emergency Preparedness Task Force
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