Month: March 2020

CMS News: Trump Administration Makes Sweeping Regulatory Changes to Help U.S. Healthcare System Address COVID-19 Patient Surge

March 30, 2020

Today, at President Trump’s direction, the Centers for Medicare & Medicaid Services (CMS) today is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. This allows hospitals and health systems to deliver services at other locations to make room for COVID-19 patients needing acute care in their main facility.

The changes complement and augment the work of FEMA and state and local public health authorities by empowering local hospitals and healthcare systems to rapidly expand treatment capacity that allows them to separate patients infected with COVID-19 from those who are not affected.

CMS’s temporary actions announced today empower local hospitals and healthcare systems to:

  • Increase Hospital Capacity – CMS Hospitals Without Walls;
  • Rapidly Expand the Healthcare Workforce;
  • Put Patients Over Paperwork; and
  • Further Promote Telehealth in Medicare

You can find a copy of the full press release here:  https://www.cms.gov/newsroom/press-releases/trump-administration-makes-sweeping-regulatory-changes-help-us-healthcare-system-address-covid-19

For additional background information on the waivers and rule changes, go to: https://www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient

For more information on the COVID-19 waivers and guidance, and the Interim Final Rule, please go to the CMS COVID-19 flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

These actions, and earlier CMS actions in response to COVID-19, 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, visit www.coronavirus.gov.  For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

WEBINAR: Modified HIPAA Compliance During the COVID-19 Emergency

Date: Wednesday, April 1, 2020

Time: 12:00 PM CST

Webinar ID: 602224

Click HERE for more information and to register.

Overview:

Emergency waivers of some HIPAA compliance requirements have been put in place to help Health Care Providers throughout the United States cope with the COVID-19 Public Health Emergency.

Although not often used, some HIPAA Rules were specifically designed to address emergencies like the COVID-19 pandemic remain in place.

All Covered Entities and Business Associates need to know how to take advantage of the new temporary HIPAA compliance procedures and refresh their familiarity with HIPAA Rules designed for the current public health crisis.

Emergency HIPAA waivers were established to lessen administrative burdens and expand ways our health care system can care for an enormously increased number of patients.

We are all facing this Public Health emergency together. The U. S. Department of Health and Human Services through CMS and its Office for Civil Rights (OCR) have issued waivers and modifications to HIPAA compliance that are extremely helpful – and would have been unimaginable two months ago. They may take further steps before the date of this webinar and if so, we will include them.

Why you should attend:

You should attend this webinar to learn how to take advantage of the new, temporary HIPAA waivers designed to reduce stress and patient surge during the COVID-19 outbreak and brush up on HIPAA Rules for use and disclosure of PHI that apply to Public Health Emergencies.

The webinar will include all modifications to HIPAA made up to the date it is presented. Don’t miss the opportunity to learn how HIPAA has changed because of the COVID-19 pandemic and how you can provide health care services more efficiently to a larger number of patients while still complying with HIPAA.

Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency

March 28, 2020

The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, to protect the privacy and security of protected health information, namely the HIPAA Privacy, Security and Breach Notification Rules (the HIPAA Rules).

View full article here.

CMS NEWS: Trump Administration Provides Financial Relief for Medicare Providers

March 28, 2020

Under the President’s leadership, the Centers for Medicare & Medicaid Services (CMS) is announcing an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers, to ensure they have the resources needed to combat the 2019 Novel Coronavirus (COVID-19). This program expansion, which includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act, is one way that CMS is working to lessen the financial hardships of providers facing extraordinary challenges related to the COVID-19 pandemic, and ensures the nation’s providers can focus on patient care. There has been significant disruption to the healthcare industry, with providers being asked to delay non-essential surgeries and procedures, other healthcare staff unable to work due to childcare demands, and disruption to billing, among the challenges related to the pandemic.

An informational fact sheet on the accelerated/advance payment process and how to submit a request can be found here: www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf

This action, and earlier CMS actions in response to COVID-19, 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, visit www.coronavirus.gov. For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

View full release here.

Hospital Letter from Vice President Pence

NHSN COVID-19 Patient Impact and Hospital Capacity Module – How to Use t…

NHSN COVID-19 Patient Impact and Hospital Capacity Module- Data Elements…

CMS NEWS: Trump Administration Engages America’s Hospitals in Unprecedented Data Sharing

March 29, 2020

Today, the Centers for Medicare & Medicaid Services (CMS) sent a letter to the nation’s hospitals on behalf of Vice President Pence requesting they report data in connection with their efforts to fight the 2019 Novel Coronavirus (COVID-19). Specifically, the Trump Administration is requesting that hospitals report COVID-19 testing data to the U.S. Department of Health and Human Services (HHS), in addition to daily reporting regarding bed capacity and supplies to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) COVID-19 Patient Impact and Hospital Capacity Module. CMS, the federal agency with oversight of America’s Medicare-participating health care providers – including hospitals – is helping the Trump Administration obtain this critical information to help identify supply and bed capacity needs, as well as enhance COVID-19 surveillance efforts. Hospitals will report data without personal identifying information to ensure patient privacy.

“The nation’s nearly 4,700 hospitals have access to testing data that’s updated daily. This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country,” said CMS Administrator Seema Verma. “America’s hospitals are demonstrating incredible resilience in this unprecedented situation and we look forward to partnering further with them going forward.”

The White House Coronavirus Task Force is already collecting data from public health labs and private laboratory companies, but does not have data from hospital labs that conduct laboratory testing in their hospital. This hospital data is needed at the federal level to support the Federal Emergency Management Agency (FEMA) and CDC in their efforts to support states and localities in addressing and responding to the virus.

Academic, University and Hospital “in-house” labs are performing thousands of COVID-19 tests each day, but unlike private laboratories, the full results are not shared with government agencies working to track and analyze the virus. By sharing this critical data, hospitals can help Federal and state government mitigate the effects of COVID-19 and direct needed resources from Federal Emergency Management Agency (FEMA) and the U.S. Government during this unprecedented crisis.

In Vice President Pence’s letter to America’s hospitals, he asks all hospitals to report data on COVID-19 testing performed in their “in-house” laboratories, which are hospitals’ onsite laboratories. To monitor the rapid emergence of COVID-19 and the impact on the healthcare system, the White House Coronavirus Task Force is requesting hospitals to report testing data to HHS each day and to the CDC’s NHSN. This new data request by the Trump Administration will help monitor the spread of severe COVID-19 illness and death as well as the impact to our nation’s hospitals. Because private and commercial laboratories already report, this letter is not applicable to them.

This action, and earlier CMS actions in response to COVID-19, 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, visit www.coronavirus.gov. For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

HHS Region 7 Update

March 27, 2020

Congress passed and the President signed the CARES Act, a $2 trillion relief package that provides much needed economic relief for American families and businesses who are hurting through no fault of their own. This legislation will provide assistance to America’s heroic healthcare workers who are on the frontlines of this outbreak, including $100 billion which will go to healthcare providers, including hospitals on the front lines of the COVID-19 pandemic, $27 billion which will go to bolstering life-saving capabilities, including developing vaccines and the development, purchase, and distribution of critical supplies and $45 billion which will go to the Federal Emergency Management Agency Disaster Relief Fund, more than doubling the amount available to support the President’s Emergency and Disaster Declarations to empower State, local, and tribal leaders to effectively respond.

See below for updates on today’s releases:

Continued Efforts to Expedite Testing: Initially, nasopharyngeal swab were the only recommended swabs to be used for diagnostic testing of COVID-19. Subsequently, FDA identified a number of other swabs that were available to collect samples. Now, FDA has newly released information that recommends for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of samples at collection sites, and that can be performed with a simpler and more readily available swab.

Expansion of Diagnostics to Test for COVID-19: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 17 emergency use authorizations have been issued for diagnostic tests, including the AvellinoCoV2 test, which is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Additionally, FDA has been notified that more than 100 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Expanding Face Masks for General Use and Conserving N95 for Health Care Workers: FDA issued an immediately in effect guidance on an Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency. The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals.

Repurposing Ventilators: FDA has issued guidance allowing ventilators from outpatient surgical centers and clinics to be modified by changing a vent. This policy will assist states with being able to identify a whole new range of ventilators that could be easily converted, add to their supply, and focused at the point of the need in their states. Anesthesiologists Patient Safety Foundation (APSF)/American Society of Anesthesiologists (ASA) has issued guidance on purposing anesthesia machines as ICU ventilators.

Maintaining Essential Health Services During an Outbreak: The WHO released Operational Guidance for Maintaining Essential Health Services During an Outbreak. This document provides guidance on a set of targeted immediate actions that countries should consider at national, regional, and local level to reorganize and maintain access to high-quality essential health services for all.

Public-Private Partnership to Develop a New Screening Tool: In partnership with the White House Coronavirus Task Force, the Department of Health and Human Services, and the Centers for Disease Control and Prevention (CDC), Apple released an app and website that guides Americans through a series of questions about their health and exposure to determine if they should seek care for COVID-19 symptoms.  The screening tool provides CDC recommendations on next steps including guidance on social distancing and self-isolating, how to closely monitor symptoms, recommendations on testing, and when to contact a medical provider.

Extending the Supply of and Providing Consumer Information on Hand Sanitizer: FDA issued guidance for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products. The FDA posted questions and answers related to consumer use of hand sanitizer during the COVID-19 public health emergency. The FDA wants to make consumers aware of the steps the agency is taking to increase the supply of hand sanitizer during this public health emergency. The questions also discuss hand washing, expiration dates and other frequently asked questions by consumers on hand sanitizer.

Avoid All Non-Essential International Travel: CDC issued a travel warning today for all individuals to avoid all non-essential international travel in an effort to curb the ongoing transmission of COVID-19.

CMS Continuing to Provide State Flexibilities: CMS has now approved 34 Section 1135 Medicaid waivers in states. CMS also approved 8 state requests to invoke emergency flexibilities in their programs that care for the elderly and people w/ disabilities in their homes & communities.

Providing Telehealth Resources for Long-Term Care and Nursing Home Facilities: CMS has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. This toolkit will aid and provide information to facilities utilizing the new telehealth flexibilities.

HRSA Gives Flexibilities to Grantees: HRSA has adopted all 13 administrative flexibilities outlined as available by OMB and has released an FAQ on these flexibilities for grantees.

Flexibility Regarding Nutrition Labeling: The FDA issued guidance on a Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. For example, restaurants may have purchased ingredients that they can no longer use to prepare restaurant food and instead wish to sell to their customers.

Joint Letter Promotes Easing Of Insurer Requirements

A letter from five health organizations to Gov. Mike Parson asks him to encourage the state’s health insurers to take actions to reduce the burden on health care providers as they respond to the challenges of the COVID-19 public health emergency. The letter describes several actions that “would have immediate benefit on improving throughput and capacity and reducing administrative burdens.” Other proposed actions would have a longer-term benefit. The signatories are the Missouri Hospital Association, the Missouri State Medical Association, the Missouri Association of Osteopathic Physicians and Surgeons, the Missouri Primary Care Association, and the Missouri Pharmacy Association.

CMS Update: Accelerated/Advance Payments for Medicare Providers

On March 28,  the Centers for Medicare & Medicaid Services (CMS) announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers, to ensure they have the resources needed to combat the 2019 Novel Coronavirus (COVID-19). This program expansion, which includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act, is one way that CMS is working to lessen the financial hardships of providers facing extraordinary challenges related to the COVID-19 pandemic, and ensures the nation’s providers can focus on patient care.

You can find a copy of the fact sheet here: www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf

You can find a copy of the press release here: https://www.cms.gov/newsroom/press-releases/trump-administration-provides-financial-relief-medicare-providers

These and earlier CMS actions in response to COVID-19, are part of the ongoing White House Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, visit www.coronavirus.gov. For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website at https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page.

CMS Update: Nursing Home Telehealth Toolkit

CMS is issuing an electronic toolkit regarding telehealth and telemedicine for Long Term Care Nursing Home Facilities. Under President Trump’s leadership to respond to the need to limit the spread of community COVID-19, CMS has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. This document contains electronic links to reliable sources of information regarding telehealth and telemedicine, including the significant changes made by CMS over the last week in response to the National Health Emergency.  Most of the information is directed towards providers who may want to establish a permanent telemedicine program, but there is information here that will help in the temporary deployment of a telemedicine program as well. There are specific documents identified that will be useful in choosing telemedicine vendors, equipment, and software, initiating a telemedicine program, monitoring patients remotely, and developing documentation tools. There is also information that will be useful for providers who intend to care for patients through electronic virtual services that may be temporarily used during the COVID-19 pandemic.

 

You can find a copy of the Toolkit here:

– https://www.cms.gov/files/document/covid-19-nursing-home-telehealth-toolkit.pdf