October 20, 2020

Volume X, Number 294

October 19, 2020

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The Key Things Health Care Providers Need to Know About COVID-19 – Ensuring Compliance with Agency Measures

According to the CDC, on January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (“WHO”) declared the outbreak of the coronavirus disease 2019 (abbreviated “COVID-19”) a “public health emergency of international concern.”  On January 31st, the Department of Health and Human Services declared a Public Health Emergency (“PHE”) for the U.S. to assist the nation’s healthcare community in responding to COVID-19.  As of March 11, 2020, the WHO declared the current outbreak a pandemic.  On Friday, March 13th, President Trump declared a national emergency to combat the virus, thereby, unleashing certain emergency powers authorizing the Secretary of United States Department of Health and Human Services (“DHHS”) to waive certain Medicare, Medicaid, and CHIP program requirements and conditions of participation under Section 1135 of the Social Security Act. 

There is no question that COVID-19 is impacting the nation’s healthcare community.  With the daily evolving spread of the disease, healthcare providers must prepare themselves for the myriad of issues associated with a PHE.  This alert addresses a summary of recent actions, including those initiated on March 13th, and potential issues for providers to consider in managing the circumstances surrounding COVID-19.

  • Centers for Medicare and Medicaid Services (“CMS”) Actions to Address the Spread of COVID-19:  On March 4th, CMS announced several actions to limit the spread of COVID-19.  These actions include: 

    • A call to action to healthcare providers to ensure that they are implementing their infection control procedures.  CMS requires facilities to maintain infection control and prevention policies as a condition of participation in federal healthcare programs.  State Survey Agencies and Accrediting Organizations have suspended, until further notice, all non-emergency survey inspections across the country.  They will focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats.  State Survey Agencies and Accrediting Organizations will begin with nursing homes and hospitals.  

    • CMS has issued “Guidance for Addressing Patient Triage and Placement of Patients with Known or suspected COVID-19.”  This guidance includes considerations for identifying patients most at risk for severe outcomes and appropriately screening visitors and patients for COVID-19.  It also addresses issues such as whether hospitals may restrict visitation of patients and Medicare regulations pertinent to such considerations.  For instance, CMS sub-regulatory guidance identifies infection control concerns as an example of when clinical restrictions may be warranted.  However, hospitals must have written policies and procedures in place that specifically define those limitations.  

    • CMS has also detailed the process for transferring patients between nursing homes and hospitals in instances where COVID-19 is suspected or diagnosed.  CMS has advised that nursing homes may accept a patient diagnosed with COVID-19 if the facility can follow CDC guidance for transmission-based precautions.   

    • CMS updated the Medicare Hospital Discharge Planning regulations in November 2019.  The regulations mandate that hospitals assess the patient’s needs for post-hospital services, and the availability of such services.  According to the regulations, when a patient is discharged, all necessary medical information (including communicable diseases) must be provided to any post-acute service provider. CMS has stated that for COVID-19 patients, this must be communicated to the receiving service provider prior to the discharge/transfer and to the healthcare transport personnel.

    • CMS issued Guidance for Infection Control and Prevention in Home Health Agencies on March 10th.

    • CMS issued Guidance for Infection Control and Prevention by Hospice Agencies on March 9th.

    • Most recently, on March 13, 2020, CMS issued a Memorandum to State Survey Agency Directors regarding Long-Term Care Facilities, to include nursing homes, skilled-nursing facilities, and assisted living facilities.  The Memorandum reinforces CMS’s directives to limit the transmission of COVID-19.  Effective as of March 13th, CMS has instructed facilities to temporarily restrict all visitors and non-essential personnel from entering these facilities, except for certain compassionate care situations, such as an end-of-life situation to protect the elderly population.  The Memorandum provides further guidance on when healthcare workers, not employed by these facilities may to provide medical care to residents and patients.

    • More information on CMS Emergency Guidance

  • Centers for Disease Control (“CDC”) Guidance on COVID-19 Preparedness:  The CDC has issues extensive guidance for hospitals, long-term care facilities, and home care providers regarding COVID-19 preparedness.  Many of CMS’s initiatives reference this guidance, particularly, with regard to appropriate screening and infection control.

  • CMS Information on Payment and Coverage Related to COVID-19: On March 5th, CMS released information on the coverage and payment related to COVID-19 under Medicare, Medicaid, CHIP, and the individual and small group markets.  CMS also announced that it developed a second Healthcare Common Procedure Coding System (HCPCS) code that can be used by labs to bill for certain COVID-19 tests. 

  • Section 1135 Waivers and Flexibilities: On Friday, March 13th, CMS announced that it will waive certain Medicare, Medicaid, and CHIP requirements pursuant to Section 1135 of the Social Security Act.  Waivers and flexibilities help hospitals and other health care facilities provide timely access to care.  These waivers will most likely include: (1) telehealth waivers, to include waiving certain site and licensure requirements, (2) waivers applicable to critical access hospitals, (3) waivers of the 3-day rule for admission to a SNF, and (4) other waivers related to the restrictions on the provision of space and allowing hospitals to associate additional physicians to provide care to patients.    

  • Food and Drug Administration (“FDA”) Notifications Related to COVID-19:  The FDA has continued to work closely with the CDC and other government agencies to monitor the disease and notify providers of impending issues related to COVID-19. One of the most significant efforts includes a multi-pronged approach, including focusing on actively facilitating efforts to surveil the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts; including enforcement to stop fraudulent activity.

  • Considerations for Healthcare Providers as Employers:  Healthcare providers also have duties to their employees.  These include not only obligations under state and federal employment laws, but also efforts to protect employees from workplace exposure.  Several national organizations, for instance, the National Association for Home Care and Hospice are issuing educational resources to address employee protection protocols in the healthcare environment. In addition, the EEOC has issued guidance reminding employers that neither the ADA nor the Rehab Act interfere with or prevent employers from following the guidelines and recommendations issued by the CDC about steps providers should take regarding COVID-19.  The EEOC has further provided guidance that can help employers implement strategies to navigate the impact of the disease in the workplace.  EEOC guidance regarding Pandemic Preparedness in the Workplace and the ADA identifies relevant established ADA and Rehab Act principles about workplace events such as:  (1) how much information an employer may request from an employee who calls in sick in order to protect the rest of its workplace, (2) when an ADA covered employer may take a body temperature of employees during a COVID-19 like event, and (3) whether the ADA allows employers to require employees to stay home if they have symptoms of the virus.

Copyright © 2020 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume X, Number 76

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About this Author

Alissa Fleming, Womble Dickinson Law Firm, Charleston, Health Care Law Attorney
Of Counsel

Alissa possesses first-hand knowledge of the healthcare industry as an attorney and registered nurse.  Her legal practice and medical background enable her to advise and represent national, regional and local healthcare providers on a broad and diverse spectrum of legal issues.

She has represented healthcare providers in health law and healthcare litigation throughout the duration of her career.  She regularly represents hospitals, long term care facilities, home health agencies, pharmacies, and professionals in healthcare litigation, regulatory...

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Ashley McGlone healthcare Attorney Womble Bond Dickinson Law Firm Winston-Salem NC
Senior Counsel

Ashley is a seasoned healthcare attorney with nearly a decade of experience advocating on behalf of healthcare providers. She brings a wealth of industry knowledge and personal insight into the regulatory and operational challenges facing healthcare clients.

Ashley advises clients on issues related to government health payment programs under Medicare and Medicaid.  Her areas of substantive focus include physician reimbursement, quality and cost program reporting requirements, health information technology, and Alternative Payment Models.  Ashley also has extensive experience working with regulatory agencies through the rule-making process.

Prior to joining Womble Bond Dickinson, Ashley was a Senior Attorney with the American Medical Association where she provided legislative and regulatory analysis on an array of issues impacting physicians. She previously served as a fellow at the US Small Business Administration and the US Department of Justice.

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Sandra Louise Weikel Miller Womble Bond Dickinson Healthcare lawyer
Partner

Sandy has helped clients through the heavily regulated and often confusing health law and healthcare litigation landscape for 25 years, and, before practicing law, she worked for more than a decade as a registered nurse, including serving as a Director of Nursing. She represents hospitals, home health agencies, hospitals, long term care facilities and other related health care providers. Sandy’s experience stretches across healthcare spectrum and she represents health care providers in a variety of health law related issues, including federal and state fraud and abuse compliance,...

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