FEDERAL HOSPITAL WAIVERS & EXTENSIONS
- Occupational Mix Surveys: CMS has extended to Sept. 3 the deadline for hospitals to submit their 2019 occupational mix surveys and supporting documentation to their MACs in response to continued COVID-19-related concerns about meeting the Aug. 3 deadline. Hospitals then may submit any needed revisions to their survey to their MAC by Sept. 10, CMS said.
- HHS PHE Extension: On July 23, HHS formally renewed the COVID-19 PHE declaration.
- CHNA Extension: Last week, the IRS extended
the deadline for conducting a Community Health Needs Assessments and adopting an implementation strategy to meet the community health needs identified through the CHNA to Dec. 31, 2020. The IRS also
provided guidance on how hospitals should document their reliance on the postponement.
- 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
CMS requesting waivers under Section 1135 of the Social Security Act.
FEDERAL FUNDING OPPORTUNITIES FOR HOSPITALS
LHA Hospital Funding Resource - Updated July 14, 2020: The LHA created a members-only
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
- Paycheck Protection Program
Flexibility Act of 2020
- 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
- Paycheck Protection Program: CMS does not intend for Paycheck Protection Program funds to impact Medicare payments to rural hospitals, CMS Administrator Seema Verma said in a tweet on Aug. 6.
- CARES Act Deadline Extension: HHS has further extended the application deadline to Aug. 28, 2020 at 11:59 p.m. ET for eligible Medicaid, Medicaid managed care, Children’s Health Insurance Program (CHIP), and dental providers that have been impacted by COVID-19 to apply for funding through the Provider Relief Fund. Eligible providers may receive up to 2% of reported revenue from patient care. The application instructions and application form are available at hhs.gov/providerrelief. Providers can download and review these documents to help complete the process through the Enhanced Provider Relief Fund Payment Portal. The site also includes a webcast recording, fact sheet, and FAQs. In order to apply, eligible providers must submit their TIN for validation through the Enhanced Provider Relief Fund Payment Portal by Aug. 28, 2020. If providers receive the results of that validation after Aug. 28, they will still be able to complete and submit their applications. For assistance, call the provider support line at 866-569-3522 from 7 a.m. to 10 p.m. CDT, Monday through Friday.
- CARES Act Reporting: On July 20, HHS shared additional information on reporting requirements for recipients of provider relief funds authorized under the CARES Act and Paycheck Protection Program and Health Care Enhancement Act. Specifically, HHS said recipients that received one or more payments exceeding
$10,000 in the aggregate from the Provider Relief Fund will be required to submit reports to HHS on how the funds have been expended using a portal that HHS will open on Oct. 1, 2020. HHS said detailed instructions regarding these reports
will be released by Aug. 17, 2020. Last month, HHS clarified that it would not require quarterly reports. For more details about the reporting timeline, view the AHA Special Bulletin.
- Additional HHS Funding: On July 17, HHS, through the Health Resources and Services Administration (HRSA),
announced that it will distribute a second round of funding totaling $10 billion from the Public Health and Social Services Emergency Fund as early as July 20 to more than 1,000 hospitals that have been highly impacted by COVID-19. On June 8, HHS requested that hospitals submit data on their COVID-19 positive-inpatient admissions from Jan. 1 through June 10. HHS will distribute funds to hospitals with more than 161 COVID-19 admissions during this time period, which equates to one admission per day. It also will distribute funds to those hospitals that experienced a disproportionate intensity of COVID-19 admissions (those that exceeded the average ratio of COVID-19 admissions/bed). Hospitals will be paid $50,000 per eligible admission. For additional information, see the
AHA Special Bulletin.
- Provider Relief Payments: On July 6, the IRS issued clarification on the tax treatment of funds received from the Provider Relief Fund. According to the FAQs, if the recipient is a taxable provider, the payments are taxable. If the provider is tax-exempt, the payments are not subject to tax unless the payment is reimbursement to the provider for lost revenue from an unrelated trade or business. Nearly 20 healthcare provider organizations, including the AHA, June 25
urged Congress to enact legislation to clarify that relief funds provided through the Public Health and Social Services Emergency Fund and other programs as part of the nation’s response to the pandemic are exempt from taxation, and that entities receiving them maintain the tax deductions attributable to these funds.
- Additional Relief Payments: On July 10, HHS, through the HRSA, announced that it plans to distribute approximately $3 billion in funding to hospitals serving a large percentage of vulnerable populations on thin margins and approximately $1 billion to specialty rural hospitals, urban hospitals with certain rural Medicare designations, and hospitals in small metropolitan areas. HHS is also opening the provider portal to allow dentists to apply for relief. On June 9, HHS
announced plans to distribute $10 billion in Provider Relief Fund payments to safety-net hospitals. HHS has expanded the criterion for payment qualification so that certain acute care hospitals meeting the revised profitability threshold of less than 3% averaged consecutively over two or more of the last five cost reporting periods, as reported to the CMS in its Cost Report filings, will now be eligible for payment. HHS expects to distribute more than $3 billion across 215 acute care facilities, bringing the total payments for safety net hospitals from the Provider Relief Fund to $12.8 billion to 959 facilities.
- Medicaid/CHIP Provider Relief Fund Payments: Recently, HHS announced that it expects to distribute $15 billion to certain CHIP providers, more specifically those that did not receive payments from the General Distribution. For eligible providers, the payment will be at least 2% of reported gross revenue from patient care, and the final amount each provider receives will be determined after their data is submitted.
Applicant providers must submit their data by July 20, 2020. Before applying through the Enhanced Provider Relief Fund Payment Portal
, provider applicants should read the Medicaid Provider Distribution Instructions
and download the
Medicaid Provider Distribution Application Form. For additional information on this distribution, as well as other distributions and requirements, visit the HHS CARES Act Provider Relief Fund
website, which includes a recording of the June 25 webcast.
- Paycheck Protection Program: On July 1, Congress passed legislation extending the PPP loan application period through Aug. 8. Organizations with fewer than 500 total employees, including hospitals, may apply to the program for loans of up to $10 million and have the loan amount forgiven if at least 60% of the loan goes to payroll expenses, among other requirements. The CARES Act created the forgivable loans to help eligible small businesses keep workers on the payroll during the pandemic. Congress then extended the loan period through Dec. 31, and the timeframe for repayment if required. On July 6, the SBA and Treasury Department released
detailed data regarding the loans made under the PPP. The loan-level data includes business names, addresses, North American Industry Classification System codes, ZIP codes, business type, demographic data, non-profit information, name of lender, jobs supported and loan amount ranges.
Medicaid/CHIP Provider Relief Fund Payment Forms & Guidance: Last week, HHS announced that it expects to distribute $15 billion to eligible Medicaid/CHIP providers, more specifically those providers that did not receive payments from the General Distribution. For eligible providers, the payment will be at least 2% of reported gross revenue from patient care, and the final amount providers receive will be determined after their data is submitted. Providers must submit their data by July 20, 2020. Before applying through the Enhanced Provider Relief Fund Payment Portal
, provider should read the Medicaid Provider Distribution Instructions and download the Medicaid Provider Distribution Application Form. For
additional information on this distribution, as well as other distributions and requirements, visit HHS’ CARES Act Provider Relief Fund website.
Paycheck Protection Program: On June 17, the SBA released a revised loan forgiveness application
for the PPP, which implements provisions of the recently-enacted PPP Flexibility Act. The agency also released an “EZ” version of the application for borrowers who: are self-employed and have no employees; did not reduce employees’ salaries or wages by more than 25% and did not reduce employees or employee hours; or experienced reduced business activity because of COVID-19-related health
directives and did not reduce employees’ salaries or wages by more than 25%. Details on these provisions are available in the EZ form instructions. Both applications give borrowers the option of using the original eight-week covered period
for loans made before June 5 or an extended 24-week covered period, the agency said. On June 16, the SBA released an interim final rule revising certain previous rules for the program to conform with the PPP Flexibility Act, recently-enacted legislation supported by the AHA. The CARES Act created the forgivable loans to help eligible small businesses keep
workers on the payroll during the pandemic.
Main Street Lending Program: On July 17, the Federal Reserve Board modified the Main Street Lending Program to provide a new borrowing option for nonprofit organizations, including hospitals. The expanded program offers loans to small- and medium-sized nonprofits that were in sound financial condition before the COVID-19 pandemic and could benefit from additional liquidity to manage during the current pandemic. The AHA has made a
series of recommendations to the Federal Reserve focused on increasing the possibility that all hospitals can make use of the Main Street Program. Among other changes from the original proposal, the modified program requires nonprofit borrowers to have a profit margin in 2019 of 2% or more (down from the proposed 5%), and reduces proposed liquidity and debt-to-cash requirements.
FAQs on Emergency Relief Fund Reporting: HHS recently updated its FAQs
on the CARES Act emergency relief fund, with special attention to provider reporting related to these funds. Specifically, providers that have received emergency relief payments do not need to submit a quarterly report to HHS or the Pandemic Response
Accountability Committee, according to the FAQs. The statutory requirement for quarterly reports related to these funds is being met by HHS’ public release of the data on each payment it has distributed. The publicly-available data on HHS’
Tracking Accountability in Government Grants System website includes the name and payment amount for
each provider that has attested to receiving the emergency relief funds and agreed to the Terms and Conditions (or has retained their payment for more than 90 days). HHS also is working with the Department of Treasury to post each provider’s
total emergency relief fund payment amount on this website. HHS confirms that the public data releases satisfy the
CARES Act reporting requirement. However, according to the FAQs, providers are still required to submit any reports requested by the HHS Secretary that are necessary to allow HHS to ensure compliance with payment Terms and Conditions. As such,
HHS will be requiring recipients to submit future reports relating to the recipient’s use of its emergency relief payments. HHS will notify recipients of the content and due date(s) of such reports in the coming weeks.
Fund Distribution Methodology for Safety-Net Hospitals: On June 11, HHS announced
the methodology used to distribute funds to hospitals serving high numbers of Medicaid beneficiaries and uninsured patients. The Department last week stated that these hospitals would be recipients of an additional $10 billion in funds from the Public
Health and Social Services Emergency Fund.
Distribution of $10B in CARES Act Funds: On June 9, HHS announced
that it will distribute $10 billion from the Public Health and Social Services Emergency Fund to hospitals that serve a disproportionate number of Medicaid patients or provide large amounts of uncompensated care. The Department identified eligible hospitals
as those with: a) A Medicare Disproportionate Payment Percentage of 20.2% or greater; b) Average uncompensated care per bed of $25,000 or more. For example, a hospital with 100 beds would need to provide $2.5 million in uncompensated care
in a year to meet this requirement; and c) Profitability of 3% or less, as reported to CMS in the most recently-filed cost report. Eligible hospitals this week will receive a minimum distribution of $5 million and a maximum distribution of
$50 million. This payment is being sent via direct deposit. For additional details, view HHS’s state-by-state distribution breakdown and the AHA’s Special Bulletin.
Medicaid & CHIP Providers: On June 9, HHS announced
additional distributions from the Provider Relief Fund to eligible Medicaid and CHIP providers that participate in state Medicaid and CHIP programs. HHS expects to distribute approximately $15 billion to eligible providers that participate in state Medicaid and CHIP programs and have not received a payment from the Provider Relief Fund General Distribution.
- Additional $250 million released for health systems' COVID-19 response: On June 2, HHS said it is providing an additional $250 million to aid health systems' response to the COVID-19 pandemic. The funding, which was authorized by the CARES Act, adds to the $100 million initially disbursed in April by the HHS Office of the Assistant Secretary
for Preparedness and Response.
- Request for Relief Fund Distribution Clarification: On June 3, leaders of the House Energy and Commerce and Senate Finance committees asked
HHS Secretary Alex Azar to clarify by June 10 the agency’s plan and timeline for disbursing COVID-19 emergency relief funds to Medicaid-dependent providers. On June 1, AHA urged HHS to quickly distribute additional emergency funds to all hospitals, including hospitals serving high numbers of Medicaid and uninsured patients,
among other recommendations.
- LHA FEMA Public Assistance Document: The LHA created a members-only
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
- 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.
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
TESTING & LABORATORY GUIDANCE
- CDC Guidelines &
- Data Reporting: When ordering COVID-19 laboratory tests or collecting specimens, healthcare providers should collect certain patient demographic information and responses to certain questions needed for COVID-19 data reporting, according to updated guidance from the CDC. According to the guidance, these data elements are critical for the COVID-19 public health response, and including them with test orders will enable the laboratories that perform the test to report the information to state and jurisdictional health departments, as required. For more information, see HHS’s recent guidance and FAQs on hospital data reporting.
- Testing Guidance Consolidated: The CDC has consolidated
its recommendations for COVID-19 testing, which it will update as additional information becomes available. The agency also released testing strategy options for high-density critical infrastructure workplaces, such as law enforcement, agriculture and critical manufacturing.
- 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:
- Drug Shortage Guidance: On Aug. 4, the FDA issued guidance on extending “in-use time” for shortage drugs. The guidance applies to 10 specific drug products.
Ventilator Devices: On Aug. 4, the FDA authorized the emergency use of three types of ventilator accessories for treating COVID-19 patients. The Lombardi Undersea subsalve oxygen treatment hood is a patient interface for helmet-based non-invasive positive pressure ventilation; a valve from VORTRAN Medical Technology 1 Inc. provides constant-flow pressure-cycled ventilator support; and a device from Nanotronics Imagining Inc. provides bi-level positive air pressure support.
Surgical Masks: On Aug. 5, the FDA issued an umbrella emergency use authorization to meet supply demands for certain disposable, single-use surgical masks that meet performance requirements for use in healthcare settings to provide a physical barrier to fluids and particulate materials to prevent exposure to respiratory droplets and large particles.
Remdesivir EUA, Antibody Tests: On July 29, the FDA updated its FAQs on the EUA of remdesivir for use on certain hospitalized COVID-19 patients. The document includes information on the changes to Gilead’s fact sheets for healthcare providers and patient caregivers. Last week, the FDA also posted a patient-and-consumer-focused FAQ about SARS-CoV-2 antibody, or serology, testing, including a guide to understanding test results and where to obtain them.
- EUA for Diagnostic Test for Asymptomatic People: On July24, the FDA reissued its EUA for the LabCorp COVID-19 RT-PCR Test to include authorized use for asymptomatic individuals and for pooled sample testing with up to five individual specimens. The FDA previously authorized emergency use of the test for patients with suspected COVID-19 and individual specimens.
- New Antibody Tests: On July 24, the FDA issued EUAs to Xiamen Biotime Biotechnology Co. and Access Bio Inc. for serology-based tests to detect SARS-CoV-2 antibodies indicating recent or prior infection. The tests are approved for use by laboratories certified under the Clinical Laboratory Improvement Amendments that meet requirements to perform moderate or high complexity tests.
- Test Resource: On July 23, the FDA updated its resource for labs performing authorized COVID-19 tests. The resource includes validated supply alternatives that labs can use to continue performing testing when there are supply issues with some molecular test components. Download the PowerPoint file, and click Slide Show > From Beginning to see the resource’s full functionality, including links to other documents.
- Treatment Guidelines: The FDA recently updated its COVID-19 treatment guidelines for corticosteroids, including dexamethasone.
- Test for Use with Pooled Samples: Last week, the FDA reissued its EUA of Quest Diagnostics’ SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. In addition, the FDA authorized the emergency use of a pair of qualitative tests for detecting SARS-CoV-2 antibodies and nucleic acids: Boston Heart Diagnostics’ molecular Boston Heart COVID-19 RT-PCR Test and Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
- Anti-Coagulant Drug: The FDA approved an abbreviated new drug application for anti-coagulant heparin sodium.
- Hotline Closure: On Friday, the FDA closed its COVID-19 hotline for questions related to COVID-19 diagnostic tests and device shortages, including PPE and respirators. Instead, the FDA said the field should use this
False Positive Results: The FDA warned
of an increased risk of false positive results from the BD SARS-CoV-2 Reagents for the BD Max System test. The FDA said the manufacturer reported that approximately 3% of results were false positives. The Agency recommends clinical laboratory
staff and healthcare providers should “consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System” and “consider confirming with an alternate authorized test.” (July 6)
EUAs: The FDA
the emergency use of the BD Veritor System for Rapid Detection
of SARS-CoV-2. The test can be used in patient care settings approved for CLIA high or moderate complexity or waived testing; however, the test’s emergency use is limited to authorized laboratories using the BD Veritor Plus Analyzer
Instrument. In addition, the FDA last week authorized the University of California San Francisco’s Clinical Labs at China Basin to use a new molecular-based
diagnostic test for SARS-CoV-2. The agency also authorized laboratories certified to perform high complexity tests under the
CLIA to use a new molecular-based diagnostic test developed by BioSewoom Inc. (July 6)
Test for Differentiating Flu from COVID-19: The FDA authorized the emergency use of a third diagnostic test that detects and differentiates flu and COVID-19 viruses from one another. The test from the CDC, along with previously-authorized tests from BioFire Diagnostics LLC and QIAGEN GmbH, require only a single
sample from patients who exhibit respiratory disease symptoms. The FDA said these tests will use fewer supplies and provide faster and comprehensive results. (July 2)
- Dangerous Alcohol-Based Hand Sanitizers Containing Methanol: On June 19, the FDA advised consumers not to use any hand sanitizer manufactured by “Eskbiochem SA de CV” in Mexico, due to the potential presence of methanol, a “toxic alcohol,” as an active ingredient, which can cause blindness and/or death when absorbed through the skin or when swallowed. Since then, the FDA has identified
additional ABHSR products that contain methanol and is working with manufacturers and distributors on a voluntary recall of these products.
- 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
- Data Reporting: On July 31, HHS released specifications for reporting certain COVID-19 laboratory data as required by the CARES Act. Under recent HHS guidance, all COVID-19 testing sites must begin reporting the data by Aug. 1 to state or local health departments for each individual tested to detect SARS-CoV-2 or diagnose COVID-19.
- Testing Resources: On June 4, the FDA released COVID-19 performance data for four more antibody test kits. The results come from the first collaboration between FDA, the National Institute of Health’s National Cancer Institute, Centers for Disease Control and Prevention and Biomedical Advanced Research and Development
Authority. In addition, the FDA released a new video for the public that explains the different categories
of COVID-19 tests, such as tests for those currently infected versus those with antibodies.
- 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
- DOL Regulations: On Aug. 3, the U.S. District Court for the Southern District of New York ruled against the DOL regarding its regulations that expanded paid leave authorized by the FFCRA.
- 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 Access: On Aug. 3, President Trump signed an executive order on “improving rural health and telehealth access,” with directives to launch a new payment model for rural healthcare; develop and implement a strategy to improve rural healthcare infrastructure; create a report describing policy initiatives to improve rural health; and propose regulations that would extend certain telehealth flexibilities.
- Telehealth Benefits, Strategies and Safeguards: On June 10, the CDC released guidance
on using telehealth to expand access to healthcare services during the COVID-19 pandemic and beyond. The guidance describes the landscape of telehealth services and considerations for healthcare systems, practices and providers.
- 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
- 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
email@example.com 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.
- 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.
- 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.
- 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
- Updated Guidance on 340B Hospital Outpatient
Sites: On June 4, HRSA updated
its guidance related to COVID-19 for 340B hospitals registering outpatient
sites. In the guidance
, HRSA is allowing 340B hospitals to register
outpatient sites and facilities before they appear on the hospital’s most
recently-filed Medicare cost report. 340B hospitals are urged to document the
hospital’s policies and procedures as they use this new flexibility to address
resource needs related to COVID-19. In addition, 340B hospitals are expected to
conform to HRSA’s existing 340B patient definition guidance. HRSA also posted a
COVID-19 FAQ on 340B hospital eligibility criteria, which is located on the
guidance webpage. In this FAQ, HRSA notes it does not have the authority to
waive current law 340B eligibility criteria.
- 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 firstname.lastname@example.org.
- 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 email@example.com.
- 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.
- Food & Drug Administration
- EUAs for Drug Products
Hydroxychloroquine & Chloroquine Side Effects: On June 15, the FDA revoked
emergency use authorizations for chloroquine and hydroxychloroquine for COVID-19 treatment. The FDA cited serious side effects, such as cardiac adverse events, in its decision. The FDA said patients who have already been administered the drugs that were
distributed under the original emergency use authorization may continue their use if deemed necessary by physicians. In related news, on June 15, the FDA said chloroquine and hydroxychloroquine could reduce remdesivir’s antiviral activity. As a result, the FDA, citing a non-clinical lab study, does not
recommend co-administration of the drugs.
- 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.
- Drug for Ventilated Patients: On June 3, the FDA approved a new
for intubated and ventilated patients in intensive care settings and non-intubated patients prior to or during surgical and other procedures. The drug’s most common side effects are hypotension, bradycardia and dry mouth.
- Remdesivir Treatment Guidelines: On July 17, NIH’s COVID-19 Treatment Guidelines Panel recommended, in situations where supplies are limited, prioritizing remdesivir for use in hospitalized patients with COVID-19 who require supplemental oxygen but are not mechanically ventilated or on extracorporeal membrane oxygenation. The panel expects to release additional updates to its recommendations for use of remdesivir soon.
- 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.
- Laboratory Alert on MTM and Cyanide Gas: On May 30, the CDC issued a
concerning the production of cyanide gas when molecular transport media is exposed to bleach. Because of this dangerous chemical reaction, the agency warned laboratories to not use PrimeStore MTM with platforms that include a disinfecting step that uses bleach.
- Vaccine Manufacturing: On June 1, HHS
a $628 million agreement with Emergent BioSolutions to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine and therapeutics as part of Operation Warp Speed.
QUALITY PROGRAM UPDATES
- Medicare Quality Reporting Programs: CMS’ blanket data reporting exceptions and extensions implemented in March across Medicare quality reporting and value-based payment programs for hospitals expired July 1. Specifically, CMS made it optional to submit data from the fourth quarter of 2019 (October through December) and the first two quarters of 2020 (January through March, and April through June); and will not use claims data from Jan. 1 through June 30, 2020 to calculate performance in its quality reporting and value-based purchasing programs. CMS expects hospitals to collect and report data for the third and fourth quarters of 2020 in accordance with regular program requirements. While CMS’ blanket reporting exception has ended, hospitals unable to meet third and/or fourth quarter 2020 data collection and reporting requirements under the hospital quality reporting and value-based purchasing programs due to COVID-19 or another event beyond their control may use the programs’ existing policies to
request an exception within 90 calendar days of the extraordinary circumstance.
- MIPS Exception for Clinicians: On June 24, CMS announced that clinicians participating in the Quality Payment Program MIPS in 2020 whose practice was significantly impacted by the COVID-19 public health emergency may apply for an exception
to reweight the MIPS performance categories. For more information, see the exception applications fact sheet and webpage.
- 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
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 MIPS under the Improvement Activities performance category for the 2020 performance period.
RHCs & FQHCs: On July 6, CMS updated MLN Matters Article: SE20016 to clarify how RHCs and FQHCs can apply the
Cost Sharing modifier to preventive services furnished via telehealth. The update includes additional claim examples and a new section on the RHC Productivity Standard.
- 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 firstname.lastname@example.org or 225-342-1525 with their intent to receive funds and potential plans for expenditures or if they have any questions.
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
CLINICAL TRIALS & STUDIES
NIH Vaccine: The first human study evaluating an mRNA COVID-19 vaccine made by Moderna Inc. produced neutralizing antibodies in healthy adults, who generally tolerated the vaccine well, the NIH reports. The 45 participants received 25-, 100- or 250-microgram injections of the vaccine. The trial expanded to 120 participants in April, including the first adults over age 55. A phase 2 trial is underway to evaluate
50- and 100-microgram doses of the vaccine in 600 healthy adults, with plans to begin a large phase 3 trial of a 100-microgram dose this month.
Mask Studies: Two new case studies affirm that cloth face coverings “are a critical tool in the fight against COVID-19 that could reduce the spread of the disease, particularly when used universally within communities,” the
CDC) said on July 14. One study,
reported in JAMA, found that adherence to universal masking policies for healthcare workers and patients reduced SARS-CoV-2 transmission within a Boston hospital system. Another study, released by the CDC, found that wearing a mask prevented the spread of infection from two hair stylists to their customers in Missouri. According to a CDC survey released last week, the share of Americans who reported wearing a cloth face covering when outside their home rose from 62% in April to 76% in May.
- 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.