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COVID-19: Federal Updates & Guidance

FEDERAL HOSPITAL WAIVERS

  • SNF Bed Waiver: CMS provided recently-released guidance (see page 7) in response to requests from hospitals to allow conversion of inpatient beds to SNF beds when there is difficulty locating available SNF units.
  • CMS Issues Additional Waivers: On April 30, the CMS issued another round of regulatory waivers and rule changes related to COVID-19. The waivers apply nationwide and are generally retroactive to March 1, 2020. They include waivers that expand access to COVID-19 testing, including serological and antibody tests; expand flexibility around treatment locations; expand access to telehealth; allow for additional workforce capacity; and eliminate certain administrative requirements. For more details, view CMS’s interim final rule with comment period, CMS’s updated new waiver summary and a related AHA Special Bulletin CMS released additional new waivers for healthcare providers. The waivers, which apply nationwide and are retroactive to March 1, 2020, reduce supervision and other requirements to allow practitioners to work to the fullest extent of their licenses. 
  • EMTALA FAQs: On April 30, CMS issued an FAQs document clarifying requirements and considerations for hospitals and other providers related to EMTALA during the COVID-19 pandemic.
  • CMS Approves Louisiana Waiver: On March 23, CMS approved  an additional 11 state Medicaid waiver requests, including one for Louisiana, under Section 1135 of the Social Security Act. These Section 1135 waivers are effective retroactive to March 1, 2020 and will end upon termination of the public health emergency, including any extensions.
  • CMS Waiver Request Letter: On March 16, the LHA sent a letter to CMS requesting waivers under Section 1135 of the Social Security Act.

FEDERAL FUNDING OPPORTUNITIES FOR HOSPITALS

LHA Hospital Funding Resource - Updated May 29, 2020: The LHA created a members-only  resource  on Federal Funding Opportunities for Hospitals to provide members with an overview of funding opportunities available to hospitals and health systems through the CARES Act, as well as other potential avenues that are identified over the course of and following the emergency. This document includes updates for: 

  • Federal Funding Opportunities for Hospitals
    • Public Health and Social Services Emergency Fund (PHSSEF)
    • Accelerated Medicare Payments
    • Small Business Administration Loans
    • Federal Reserve Emergency Lending Program
    • FCC Telehealth Program
  • Automatic Federal Fiscal Relief
    • Medicare Hospital IPPS Add-On Payment for COVID-19 Patients
    • Adjustment of Sequestration
    • Delay of Payment Of Employer Payroll Taxes
    • Extension of Work Geographic Index Floor Under the Medicare Program
    • Delay in Medicaid Disproportionate Share Hospital Reductions
  • LHA FEMA Public Assistance Document: The LHA created a members-only  resource FEMA Public Assistance. FEMA Financial Assistance Update: Recently, FEMA updated its policy  for determining medical care costs eligible for assistance under its Public Assistance Program available to government entities and certain private non-profit organizations during the COVID-19 emergency.
  • Financial Support Chart: A new resource developed by Jones Day provides a summary of federal financial support provisions, information on eligibility, and the amount of funding available through each opportunity.
  • Rural COVID-19 Testing: On May 20, HRSA, part of HHS provided  $225 million to RHCs for COVID-19 testing. Of that funding, Louisiana received approximately $8.5 million.
  • Novartis US Foundation Local-Relief Funds: On April 3, the Novartis US Foundation established a $5 million fund to support local initiatives and communities impacted by the COVID-19 crisis. Hospitals that are verified 501(c)(3) organization are  invited to apply for grants in the range of $100,000 to $250,000 for programs that strengthen local and national healthcare infrastructure.

CDC CLINICAL GUIDANCE & RESOURCES

  • Strategies for Optimizing the Supply of N95 Respirators: CDC strategies that cover Conventional Capacity, Contingency Capacity and Crisis Alternate Strategies.
  • CDC Framework: The CDC released a framework for providing non-COVID-19 clinical care during the pandemic, based on the level of community transmission and potential for patient harm from deferring in-person care.

  • Pediatric Condition: On May 14, the CDC issued a health advisory warning of COVID-19-associated multisystem inflammatory syndrome in children (MIS-C). The CDC recommends that healthcare providers report “any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome.”


CMS CLINICAL GUIDANCE & RESOURCES

    • New Infection Control Guidance: On April 9, CMS issued a series of updated guidance documents focused on infection control to prevent the spread of COVID-19 in a variety of inpatient and outpatient care settings.  


    TESTING & LABORATORY GUIDANCE

    • CDC Interim Guidelines
      • Antibody Testing: On May 24, the CDC issued two sets of interim guidelines for serologic methods used for monitoring and responding to the COVID-19 pandemic. The guidelines, which the CDC says it will update regularly, include recommendations for choice of test and testing strategy; individuals who test positive for anti-SARS-CoV-2 antibodies; and additional considerations on the use of serologic tests.
      • Updated CDC Testing Guidelines: CDC's testing priority guidance gives first priority to testing hospitalized patients and symptomatic healthcare workers and guidelines for collecting, handling and testing COVID-19 clinical specimens to allow for self-or healthcare worker-collected nasal or nasal turbinate swabs if nasopharyngeal swab is not possible.
      • CDC Guidance: Updated Guidance Evaluating and Testing Persons for COVID-19 (03/08/20)
      • CDC Lab Information: CDC Information for Laboratories
    • FDA Resources:
      • Testing-Related EUAs
      • Resources & Guidance on Antibody Testing 
      • Abbott Point-of-Care Test: On May 14, the FDA announced that, based on early data, the Abbott ID NOW point-of-care test to diagnose COVID-19 may return false negative results and stated that it will continue to review data as the company conducts post-market studies to better understand the cause. An FDA official said the test can still be used to correctly identify positive cases in minutes; however, “negative results may need to be confirmed with a high-sensitivity authorized molecular test.”
      • Antibody Testing: On May 4, the FDA said it is adopting more stringent standards for COVID-19 antibody tests by boosting oversight through new standards of accuracy and requiring antibody test manufacturers to submit new information proving the testing quality. Additionally, the FDA stated that laboratories certified for high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), including hospital laboratories, that develop their own laboratory-developed COVID-19 antibody test through an earlier agency policy , are also encouraged to seek an emergency use authorization (EUA). Also on May 4, the FDA authorized the first serology test in which independent federal data provided the scientific evidence used to support the authorization. EUROIMMUN US Inc.’s Anti-SARS-CoV-2 ELISA (IgG) test, which will aid in identifying individuals with an adaptive immune response to SARS-CoV-2, is certified for emergency use by CLIA-certified labs. 
      • At-Home Diagnostic Test Sampling: On April 20, the FDA authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization for the Laboratory Corporation of America COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
      • FDA Policy Change for Test Results: On March 15, FDA issued a policy change that removed a requirement that labs send to the CDC samples of their coronavirus test results to confirm positive cases, which has reduced the number of tests needed per patient. It also is expected to decrease turnaround time for test results, with labs granted the authority to confirm positive COVID-19 cases.
      • FDA Testing Guidance and FAQs: On March 16, the FDA posted a Guidance Document on “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The FDA updated its COVID-19 diagnostic testing FAQs
      • SARS-CoV-2 Antibody Test: On April 1, the FDA authorized emergency use of two new diagnostic tests for COVID-19, including the first reported test to measure SARS-CoV-2 antibodies in blood collected from individuals with suspected COVID-19.
    • Updated Guidelines & Criteria: On April 27, the Trump Administration released a series of guidelines for testing and rapid response programs in anticipation of reopening the nation’s economy. The federal government will support state-based efforts by expanding the number of testing platforms, increasing testing and laboratory supplies and capacity, and enhancing sample collection. As part of the effort, the CDC updated its evaluation and laboratory testing criteria.
    • Antibody Testing Primer: On April 20, IDSA released a primer on the current state of SARS-CoV-2 serology tests and the research and policy questions they raise.
    • HIPAA Rules: On April 9, HHS’ OCR issued a Notification of Enforcement Discretion stating that OCR will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered healthcare providers or their business associates in connection with the good faith participation in the operation of a COVID-19 Community-Based Testing Site during this nationwide public health emergency.
    • Licensed Pharmacists: On April 7, HHS issued guidance authorizing licensed pharmacists to order and administer COVID-19 tests approved by the FDA, including serology tests.
    • CMS CLIA Laboratory Requirements: On March 26, CMS announced a relaxed enforcement policy to meet the urgent need to expand laboratory capacity, under the CLIA during the COVID-19 public health emergency with respect to review of pathology slides, proficiency testing, alternate collection devices, and requirements for a CLIA certificate.
    • Evaluating PUI: Interim Guidance for Public Health Personnel Evaluating PUIs and Asymptomatic Close Contacts of Confirmed Cases at Their Home or Non-Home Residential Settings

    WORKFORCE

    • Employee Benefit Deadline Extensions: DOL and the Department of Treasury are extending certain deadlines affecting employee benefit plan participants’ rights to health coverage, portability and continuation of coverage under COBRA, and to file claims or appeal denied claims. In addition, DOL’s EBSA is extending the time for plan officials to furnish certain notices and disclosures under the ERISA if they make a good faith effort to furnish the documents as soon as administratively feasible.
    • New Toolkit for Health Workforce Challenges: CMS and the Assistant Secretary of Preparedness and Response released a new toolkit that includes resources and tools for state and local healthcare decision makers managing healthcare workforce challenges in response to the COVID-19 emergency.
    • IRS Tax Filing: On April 9, the IRS extended the deadline  for tax-exempt organizations and fiscal year businesses to file tax returns and payments due between April and June until July 15.
    • FAQs on Employment Taxes: On April 4, the IRS released FAQs related to the deferral of deposit and payment related to certain employment taxes as authorized by the CARES Act.
    • Clarification on Healthcare Guidance: On March 28, the U.S. DOL Wage and Hour Division released an updated set of “Questions and Answers” that provide additional guidance concerning healthcare providers and emergency responders. The EMFLEA and the EPSLA authorize the DOL to issue regulations to exempt healthcare providers and emergency responders from eligibility for coverage under the FFCRA. In addition, the FFCRA provides that employers of healthcare providers and emergency responders may elect to exclude these employees from coverage. 
    • Workforce FAQs: On April 1, the U.S. DOL released information on common issues employers and employees face when responding to COVID-19, and its effects on wages and hours worked under the Fair Labor Standards Act; job-protected leave under the FMLA; and paid sick leave and expanded family and medical leave under the FFCRA. The new law allows employers of healthcare providers or emergency responders to elect to exclude such employees from eligibility for the leave provided under the FFCRA.

    TELEHEALTH GUIDANCE

    • Medicare Telehealth RHC/FQHC Payment Rate: On April 17, CMS released guidance stating that the agency will pay RHCs and FQHCs a $92 rate for distant site telehealth services provided to Medicare beneficiaries during the COVID-19 emergency.
    • Novitas Guidance: Novitas has issued additional guidance to assist providers with telehealth and telephone services during this public health emergency. 
    • FCC Telehealth Program: On April 9, the FCC published in the Federal Register its Report and Order to formally adopt the COVID-19 Telehealth Program. While accepting applications from eligible entities through its Electronic Comment Filing System under WC Docket No. 20-89, the Commission also requests a courtesy that a copy of the application also be sent via email to EmergencyTelehealthSupport@fcc.gov. The AHA urged the FCC to reconsider immediately its decision to limit participation in the COVID-19 Telehealth Program to certain nonprofit or public healthcare providers, noting that the CARES Act included “no such restriction” on the program’s $200 million in funding.
    • FCC Connected Care Pilot Program: On April 2, the FCC adopted final rules for the longer-term Connected Care Pilot Program, proposed last year. Through this program, the FCC will distribute $100 million over three years for telemedicine projects to improve health outcomes for low-income patients, including veterans and individuals living in rural areas.
    • DLT Grant Program: The Rural Utilities Service announced a second window for applications for its Distance Learning and Telemedicine (DLT) Grant Program. The first application window for paper submissions closes April 10, 2020. The second application window for electronic submissions is April 14 through July 13, 2020. This funding opportunity can be used to support infrastructure and purchase equipment to provide telemedicine. For questions, contact the DLT Program at dltinfo@usda.gov or 202-720-0800.
    • CMS Broadens Access: On March 17, the AHA issued an advisory regarding CMS broadening access to Telehealth during COVID-19 Public Health Emergency.
    • Medicaid Telehealth Guidance for States: On April 2, CMS released an informational bulletin to states identifying opportunities for using telehealth to increase rural and other access to Medicaid services and treatment for substance use disorders, including during the COVID-19 emergency.

    LICENSURE ORGANIZATIONS

    • NABP Passport: On March 28, LSBP issued a memo recognizing the NABP Passport as a valid service in Louisiana to allow pharmacists and pharmacy technicians temporary permission to practice in states where they are not licensed. To participate, pharmacists and pharmacy technicians should obtain an NABP Passport. There is no cost to the applicant.
    • NCLEX Updates:
      • NCSBN announced the re-opening of additional NCLEX Pearson Vue testing site locations for RN applicants in Louisiana. The additional locations are expected to become available the week of April 19, 2020. For more information, consult the Louisiana State Board of Nursing website or the NCSBN website.
      • NCSBN has made a 6-month extension for new grads who have expired temporary licenses and who cannot take NCLEX for the first time. Learn more on the COVID-19 Impact to NCLEX Candidates website.

    SURVEY UPDATES

    • Joint Commission Surveys: In a May 27 notice, TJC announced that regular accreditation survey activities would resume in June, but with changes to protect safety. According to the notice, TJC will begin to contact those organizations that are due for a survey to assess if a survey can be conducted safely, including using appropriate physical distancing practices and virtual capabilities to eliminate unnecessary or large group interactions. Organizations being surveyed will be expected to provide surveyors with masks and other appropriate PPE while onsite. TJC also stated that surveys will focus on a thorough assessment but will not retroactively review compliance. The notice also provided a link to TJC’s COVID-19 resource page.
    • Joint Commission Accreditation and Certification Performance Measure Reporting: The Joint Commission sent an update to state hospital associations announcing that it has made data submission for accreditation (ORYX) and certification (with standardized measures) optional for 4Q2019, 1Q2020 and 2Q2020 time periods. Questions regarding these modified requirements may be directed to the ORYX Help email.

    PATIENT PROTECTIONS

    • PHI Scam Alert: On April 3, OCR warned HIPAA-covered entities of an individual posing as an OCR investigator attempting to obtain patients’ PHI. To verify that someone is an OCR investigator, ask for the individual’s email address, which will end in @hhs.gov, and ask for a confirming email from the OCR investigator’s hhs.gov email account. For more information, contact OCRMail@hhs.gov.
    • HHS Civil Rights Protections: On March 28, HHS' OCR issued a bulletin  focused on ensuring that covered entities do not unlawfully discriminate against people with disabilities when making decisions about their treatment during this pandemic.
    • PHI Guidance: On March 24, HHS issued guidance on how covered entities may disclose protected health information about an individual who has been infected with or exposed to COVID-19 to law enforcement, paramedics, other first responders, and public health authorities in compliance with the HIPAA Privacy Rule.

    340B UPDATES

    • 340B Audits: HRSA announced that it is moving towards conducting 340B Program covered entity audits remotely (virtually) for the next several months. If a covered entity has questions regarding an audit, contact 340baudit@thebizzellgroup.com.
    • 340B Hospitals: FAQs: HRSA requests all 340B hospitals that believe they are faced with a specific circumstance that could affect their compliance or 340B eligibility to contact the 340B Prime Vendor (Apexus) at 1-888-340-2787 (Monday through Friday, 9 a.m. to 6 p.m. ET) or apexusanswers@340bpvp.com.

    CYBERSECURITY

    • FBI Alerts: View all the FBI alerts regarding COVID-related cybersecutiry issues. 
    • Cybersecurity Resources: The AHA has released a compendium of resources for hospitals and health systems related to cybersecurity threats during the COVID-19 pandemic. 

    PHARMACY/PHARMACEUTICALS

    • Food & Drug Administration
      • EUAs for Drug Products
      • FDA Drug Approval: Recently, the FDA approved two abbreviated new drug applications, Dexmedetomidine hydrochloride 0.9% sodium chloride injection and Succinylcholine chloride injection USP 200 mg/10 mL.
      • Report Adverse Drug Reactions: The FDA encourages healthcare professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
      • Treatment Caution: On April 24, the FDA issued a Drug Safety Communication to remind healthcare providers of the need to closely monitor patients for serious and potentially life-threatening side effects of hydroxychloroquine and chloroquine when used off-label to treat COVID-19.
      • Propofol Drug Products: On April 22, the FDA issued guidance allowing pharmacies and outsourcing facilities to repackage, under certain conditions and during the public health emergency, FDA-approved propofol drug products for hospitals having difficulty obtaining adequate supplies in the sizes they use to support or treat patients with COVID-19.
      • Hospital Utilization of Home-Use Blood Glucose Meters: On April 13, the FDA released an FAQ document on hospitals’ utilization of home-use blood glucose meters during the COVID-19 health crisis. 

    • DEA Exceptions: The DEA issued three exceptions to regulations for DEA-registered hospitals and clinics effective from April 10 until the public health emergency ends. One exception allows DEA-registered hospitals and clinics, under their existing DEA registration, to handle controlled substances at their satellite hospital/clinic locations as long as certain conditions are met. DEA is also providing flexibility to allow distributors to ship controlled substances directly to these satellite hospitals/clinics under certain conditions. A second exception allows narcotic treatment programs to accept deliveries of narcotics without providing an authorized signature at the time of delivery in an effort to prevent the spread of COVID-19. Finally, DEA issued another temporary exception to allow DEA-registered dispensers, such as hospitals, pharmacies, and physicians, to distribute controlled substances beyond 5% of the total number of dosage units of controlled substances distributed and dispensed during the same calendar year without being required to register as a distributor.
    • DEA Controlled Substances Update: On April 7, the DEA said it is increasing annual caps for controlled substances that are in high demand because of the COVID-19 crisis.
    • Chloroquine Phosphate Guidance: The CDC issued guidance on severe illness associated with using non-pharmaceutical Chloroquine Phosphate to prevent and treat COVID-19.

    QUALITY PROGRAM UPDATES

    • Quality Reporting and Value-based Purchasing Programs: On March 27, CMS released a guidance memo describing specific changes to CMS provider, hospital and post-acute care quality reporting programs.   
    • CMS Data Reporting Exceptions & Extensions: On March 22, CMS announced it is granting exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submission for those programs. View the news release for a list of programs that have been granted exceptions or extensions.
    • MIPS Quality Payment Program: CMS released a factsheet outlining MIPS extreme and uncontrollable circumstances policy and procedures for MIPS-eligible clinicians affected by COVID-19.
      • Clinical Trial Data: On April 20, CMS announced that clinicians may now earn credit in the MIPS for participation in a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity. In order to receive credit for this new improvement activity, clinicians must attest that they participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study.
      • MIPS Exception: CMS recently extended the 2019 MIPS data submission deadline to April 30 at 8 p.m. ET. It also extended the MIPS automatic extreme and uncontrollable circumstances exception to individual clinicians; and reopened the exception application process to all other MIPS clinicians, including those who already submitted some or all of their data.
      • On April 28, CMS issued a letter  sharing additional details regarding the ability for clinicians who participate in a COVID-19 clinical trial to report their findings to a clinical data repository or registry to earn credit in the Merit-Based Incentive Payment System (MIPS) under the Improvement Activities performance category for the 2020 performance period. 

    RURAL HOSPITALS

    • RHC and FQHC Flexibilities: On April 30, CMS released a revised MLN Matters Special Edition Article on new and expanded flexibilities for RHCs and FQHCs during the COVID-19 Public Health Emergency.
    • Case Studies: The AHA has released several case studies featuring rural hospitals, which may be a beneficial resource for rural hospital that want to quickly implement their own solutions to help care for patients.
    • SHIP Funding: The LHA received news from the Health Resources and Services Administration (HRSA) regarding new funding through the CARES Act specific to COVID-19 related activities. The funding will be awarded through the Small Rural Hospital Improvement Program (SHIP) and will support rural hospitals that are seeing increased demands for clinical services and equipment, as well as experiencing short-term financial and workforce challenges related to meeting the needs of patients with COVID-19. On April 2, the LHA sent an Alert to hospitals that were included in LDH’s funding request. These hospitals are asked to contact LDH Rural Hospital Sustainability Manager Kandi Smith at the kandi.smith@la.gov or 225-342-1525 with their intent to receive funds and potential plans for expenditures or if they have any questions.
    • Fact Sheet: On March 31, the AHA has created a two-page fact sheet outlining provisions in the CARES Act to help rural hospitals and critical access hospitals.

    • Rural Health Care Program Deadlines: On March 26, the FCC extended the Rural Health Care Program application window to June 30, 2020. 

    LONG-TERM CARE FACILITY GUIDANCE

    • Nursing Home Guidance: On April 3, CMS issued critical recommendations to state and local governments and long-term care facilities, to help mitigate the spread of COVID-19 in nursing homes.

    ADVANCE DIRECTIVES & PALLIATIVE CARE TOOLS

    • Respecting Choices Planning and Support: Resources for COVID-19 : Facilitates proactive discussions ahead of severe illness, including tools to support treatment decisions and planning guides
    • Center to Advance Palliative Care: COVID-19 Toolkit : Crisis communication and symptom management protocols for all clinicians and tools to help palliative care teams address high levels of volume and stress during a crisis

    OTHER RESOURCES

    • Blood Donation Guidance: On April 2, the FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components. To account for COVID-19, the agency is providing notice of alternatives to certain blood donor eligibility requirements for the duration of the pandemic.
    • HHS Hospital Inquiries: HHS announced that it has established a new email address, HospitalCOVID19@hhs.gov, for hospitals and health systems as a one-stop resource to triage a wide range of COVID-19 inquiries across HHS’s offices and operating divisions.
    • Open Payments Program Reporting Requirements: CMS posted an announcement regarding the deadline for submitting records to the Open Payments Program. While CMS does not have the authority to extend the submission window past the deadline, it has released an FAQ document that provides hospitals guidance on issues related to reporting on or before the March 31, 2020 deadline.
    • Interoperability Rule: On April 21, CMS announced that it will give hospitals until July 1, 2021 to implement admission, discharge and transfer notification requirements once its final rule on interoperability and patient access is published in the May 1 Federal Register.
    Louisiana Hospital Association

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