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Tuesday, August 11, 2020

Help in Evaluation of COVID-19 Data

  • Although allergists aren’t usually involved in public policy or recommendations to agencies related to COVID-19, we often are asked to interpret the data for our patients and to make decisions about our employees or practices relative to community transmission.
  • This 11-page publication from the Societal Experts Action Network, an activity of the National Academies of Sciences, Engineering and Medicine, can help us understand the limitations of the various data types reported for COVID-19, and the best ones to use.
  • The PDF can be downloaded for free from this website.

President Issues Executive Order on Telehealth

  • You may have heard the news, but here are some details that apply to allergists, although most of the order is directed at rural healthcare.
  • The order instructs the Secretaries of the Department of Health and Human Services (HHS) and Agriculture to develop and implement a strategy to improve the physical and communications healthcare infrastructure available to rural Americans. This is subject to applicable laws and availability of appropriations. This would help us communicate with our rural patients, since recent information related to remote learning for schools indicate that up to 30% of rural America lacks the bandwidth to participate.
  • The order also instructs the Secretary of HHS, within 60 days, to review the temporary measures related to telehealth services to Medicare beneficiaries and propose a regulation to extend them beyond the duration of the public health emergency, and some of the temporary measures require a legislative fix.
  • This order does not apply to Medicaid extension of telehealth, which depends on the states. The AAAAI has advocated for you to the states to consider similar extensions for Medicaid patients.

HHS Provider Relief Fund FAQs Updates

  • Don't forget that the HHS Provider Relief Fund Phase 2 General Distribution is now accepting additional applicants, after HHS had announced that certain Medicare providers would be given another opportunity to receive additional Provider Relief Fund payments. More details can be found here. These eligible providers may now submit their application for possible funds by August 28, 2020.
  • There are several updates to the FAQs, but here are the important ones that impact most allergists:

Is there a set period of time in which providers must use the funds to cover allowable expense or lost revenues attributable to COVID-19? (Modified 7/30/2020)

As explained in the notice of reporting requirements on the Provider Relief Fund website, reports on the use of Provider Relief Fund money must be submitted no later than July 31, 2021, and accordingly HHS expects that providers will fully expend their payments by that date. HHS will provide directions in the future about how to return unused funds. HHS reserves the right to audit Provider Relief Fund recipients in the future and collect any Relief Fund amounts that were used inappropriately. All payment recipients must attest to the Terms and Conditions, which require the submission of documentation to substantiate that these funds were used for increased healthcare related expenses or lost revenue attributable to coronavirus.

Are Provider Relief Fund payments to commercial (for-profit) organizations subject to Single Audit in conformance with the requirements under 45 CFR 75 Subpart F? (Modified 7/30/2020)

Commercial organizations that receive $750,000 or more in annual awards have two options under 45 CFR 75.216(d) and 75.501(i): 1) a financial related audit of the award or awards conducted in accordance with Government Auditing Standards; or 2) an audit in conformance with the requirements of 45 CFR 75 Subpart F. Audit reports of commercial organizations must be submitted directly to the U.S. Department of Health and Human Services, Audit Resolution Division at AuditResolution@hhs.gov.

CMS Updates FAQs on Medicare FFS Billing

  • There have been several updates to the FAQs since mid-July, which includes questions about subsequent E/M billing for visits after assessment and collection of COVID-19 specimen for a new patient (page 10), and how the CS modifier should be applied to telehealth services and/or E/M visits (page 69).

AMA Starts #MaskUp Campaign

  • In an effort to increase the use of masks among the U.S. population, the American Medical Association (AMA) has started the #MaskUp campaign with a toolkit that contains a variety of social media posts/videos that emphasize the importance of mask use. These can be used by your practices to encourage your patients to wear a mask. The toolkit can be found here.

Hospitalization Rates and Characteristics of Children Hospitalized With COVID-19

  • As our patients potentially head back to school in the next month, allergists need to be aware of the data related to children and COVID-19, since their parents are getting mixed messages from several sources.
  • The August 7 edition of the Morbidity and Mortality Weekly Report (MMWR) presents the results of rates and characteristics of hospitalized patients <18 years of age from COVID-NET, which is a surveillance for confirmed COVID-19 cases in 99 counties in 14 states.
  • From March 1 to July 25, 576 hospitalized children were reported to COVID-NET. The median age was 8 years old, infants <3 months accounted for 18.8%. Of all the children, Hispanics (45.8%) and Blacks (29.7%) accounted for the majority of admissions. The cumulative rate was 8.0 per 100,000 (adults are 164.5 per 100,000) and was highest among children <2 years old (24.8) followed by 5-17 years old (6.4) and 2-4 years old (4.2).
  • 42.3% had an underlying medical condition: obesity in 37.8% (children over age 2), chronic lung disease in 18%, and prematurity 15.4% (children <2 years).
  • 33% were admitted to the ICU (about double the estimates for children with influenza), 5.8% were intubated, and one child died.
  • 10.8% of 83 children for whom information was received were diagnosed with MIS-C.
  • The MMWR can be accessed here

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, August 3, 2020

AAMC Issues Roadmap for COVID-19

  • The Association of American Medical Colleges (AAMC) has issued The Way Forward on COVID-19. “This plan focuses on a set of immediate, evidence-based, commonsense actions the AAMC believes is essential to contain the virus and end the pandemic by addressing critical shortages, improving and broadening testing, reducing the virus’s spread, reopening schools safely, expanding health insurance coverage, and prioritizing distribution of the vaccine. It also identifies longer-term actions that must be taken to protect and strengthen public health, reduce health disparities, and improve the overall health of our nation and its people.”

HHS Report on Expanding Telehealth Favorable

  • The Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) issued a brief on telehealth on July 28, which stated: “The report concludes there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services – when many beneficiaries and providers were concerned with transmission of COVID-19. Future research could examine whether these flexibilities were effective and if telehealth may have improved access to care and health outcomes among underserved beneficiaries.” The brief can be found here.

Cigna Announces Extension of COVID-19 Coverage 

  • Cigna announced on July 29 that their virtual care and eConsult guidelines are extended until December 31, 2020. Cigna will allow providers to bill a standard face-to-face visit for all virtual care services, including those not related to COVID-19, through December 31, 2020. Read more.

Reimbursement for Counseling About Self-Isolation at the Time of COVID-19 Testing

  • The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have announced provider reimbursement is available for counseling patients to self-isolate at the time of COVID-19 testing.
  • These counseling services are covered by Medicare. Physicians and other practitioners furnishing counseling services to people with Original Medicare should use existing and applicable coding and payment policies to report services, including evaluation and management visits.
  • Further details can be found on pages 7-9 of this resource.

CDC COCA Call on August 4

  • The CDC holds regular Clinician Outreach and Communication Activity (COCA) calls that are available to all clinicians on a variety of topics. Most are related to COVID-19 or aspects of care related to the public health emergency (PHE).
  • On August 4 from 2:00 to 3:30 pm ET, the call will cover COVID-19 & Telehealth Implementation: Stories from the Field.
  • These calls are recorded and will be available starting a few hours after the call. Free CE is offered for this call and advanced registration is not required.
  • Connection information is available on the CDC COCA Call webpage.

Congressional Activity to Expand and Extend Telehealth

  • There are now three bills in Congress to make the changes, expansions and flexibilities established during the PHE permanent. The COVID-19 HEALS Act provides telehealth access to part time and hourly employees and extends the telehealth flexibilities through the end of the PHE or through 2021, the CONNECT for Health Act explores ways to expand telehealth and begins to permanently remove some of the restrictions, and the Telehealth Modernization Act would make permanent in-home visits and rural telehealth access and make permanent other current temporary changes.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, July 28, 2020

Here are today's important updates:

HHS Telemedicine Hack Series

  • HHS Telemedicine Hack is a 10-week virtual, peer-to-peer learning community to accelerate telemedicine implementation for ambulatory providers. Components of Telemedicine Hack include: Five teleECHO sessions; five virtual “office hour” discussion panels; and inter-session peer-to-peer learning facilitated via virtual discussion boards. CME/CEU credits are available at no cost to participants.
  • Telemedicine Hack sessions take place on Wednesdays from July 22 to September 23, 2020, at 12:00 to 1:00 pm ET.
  • You can still sign up for individual sessions here.

Possible ACP Bulk Buying Program Pending AAAAI Member Interest

  • The American College of Physicians (ACP) is offering a collaborative PPE buying opportunity to medical specialty societies. The AAAAI would like to know how many RSL societies would be interested in participating.
  • The AAAAI would need to commit to making a bulk purchase so there would be some financial risk to the organization. The price break for PPE items would be dependent on how many members participated in the program. The society decides what PPE items to offer to their members and promotes the sale over a one week period (probably August 24-31). A verified members link from the society website to Project N95 (an independent entity) takes orders, purchases the PPE from suppliers, and fulfills and ships orders. The AAAAI needs to commit by the end of the week if we would be interested in participating. Let your RSL Governor know if you are interested.

Guidance for Asthma and Food Allergic Children in School Will Be Coming

  • The AAAAI Office of School-based Management of Asthma, the AAAAI Asthma, Cough, Diagnosis and Treatment Committee, and the National Association of School Nurses are working on a pragmatic approach for treatment of asthma and prevention of food allergy reactions in schools this fall. Look for this to come out in August.

FDA Announces Additional Hand Sanitizer Recalls

  • There are now 77 different hand sanitizer products on the Food and Drug Administration (FDA) recall list, all manufactured in Mexico. The list can be found here.

Senate GOP Stimulus Plan Highlights

  • Senate Majority Leader Mitch McConnell and his Republican colleagues released a series of bills on Monday which constitute the initial drafts of the Senate Republican COVID relief package.
  • American Workers, Families, and Employers Assistance Act: Portions that are important to our membership include the extension of federal unemployment compensation at $200/week until October 5, 2020, and after that an amount equal to 70% of average weekly wages minus base amount which is defined in the bill, until November 30, 2020, (base amount is determined by a somewhat complicated formula) but return to work rules will apply. Also included are grants to states for certain increased expenditures; a stimulus payment in the form of a tax refund of $1,200 ($2,400 for joint filers) and $500 for each dependent, with adjustments for high incomes; enhanced employee hiring and retention payroll tax credit which increases the previous payroll tax credit to 65% from 50% (with limits and modifications to the definition of an eligible employer); employment tax credits for PPE; workplace reconfigurations and technology expenses; and an extension of telehealth waivers and policies to the end of 2021 (although the Secretary is not required to extend a specific waiver or policy if not appropriate for extension) subject to Medicare Payment Commission (MedPac) evaluation and analysis. The bill can be found here.
  • Paycheck Protection Program (PPP): Continuing Small Business Recovery and Paycheck Protection Program Act, which has four main components: SBA 7(a) loans to Recovery Sector Businesses, PPP second draw loans, PPP improvements, and Small Business Growth and Domestic Production Investment Facility. Details can be found here.
  • Liability reforms: The SAFE TO WORK Act.
  • The Safely Back to School and Back to Work Act includes improving earlier access to diagnostic tests, sustained on-shore manufacturing capacity for public health emergencies, improving and sustaining state stockpiles and strengthening the Strategic National Stockpile, modernizing infectious disease data collection, Centers for Public Health Preparedness, telehealth benefits for employees, protection of human genetic information, back to work child care grants, and several other education provisions. For details, go here.
  • An appropriations package, including an additional $5.3 billion for the Defense Production Act, $25 billion for the CARES Act Provider Relief Fund, $3.4 billion for the Centers for Disease Control and Prevention (CDC), $15.5 billion for the National Institutes of Health (NIH), $16 billion for testing and contact tracing, etc.
  • There is much negotiation that still needs to take place with the Democrats, so many of these items may change.

NIH Leaderhip Details Unprecedented Initiative to Ramp Up Testing for COVID-19

  • In this article published in the New England Journal of Medicine, scientific leaders from the NIH set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease.
  • The Rapid Acceleration of Diagnostics (RADx) program was established to fill the need for the nationwide deployment of low complexity, point of care molecular diagnostics with rapid results.
  • RADx includes four major components to enable approximately 6 million daily tests in the United States by December 2020: RADx-tech aims to identify, accelerate development, scale up and deploy innovative point-of-care technologies throughout the fall of 2020; RADx Advanced Technology Platforms (RADx-ATP) will support the scale-up of more advanced technologies that can achieve immediate, substantial increases in capacity; RADx Radical (RADx-rad) will focus on truly non-traditional approaches for testing that have a slightly longer horizon; and RADx Underserved Populations (RADx-UP) will establish community-engaged implementation projects to improve access to testing in underserved and vulnerable populations.

Executive Order Related to Epinephrine Auto-Injector Pricing

  • One of President Trump’s recent Executive Orders stated that injectable epinephrine would be available to patients at 340B pricing. This order only applied to Federally Qualified Health Centers (FQHCs) who are 340B providers.
  • According to health lawyers, this will not significantly impact the price for the majority of our patients. FQHCs already sell drugs at a discount to patients and there is some doubt whether the Executive Order will change much of that, according to an article in Bloomberg News.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, July 24, 2020

Here are today's important updates:

HHS Extends the Public Health Emergency

  • On July 23, Department of Health and Human Services (HHS) Secretary Alex Azar extended the public health emergency, which was due to expire July 25, for another 90 days.
  • This means that all the waivers, rules and regulatory flexibilities that have been in place will continue.

More Vaccine News

  • The Adenovirus vector COVID-19 vaccine being developed by Oxford University and AstraZeneca demonstrated the ability to generate both T cell and antibody responses against SARS-CoV-2 in a study of over 500 adults. The results of this phase 1/2 study were published in The Lancet.

Updated CDC Guidance: When You Can Be Around Others After You Had or Likely Had COVID-19

  • This guidance was updated on July 16.
  • If a person thinks or knows they had COVID-19, and had symptoms, they can be around others after at least 10 days after symptoms first appeared, and at least 24 hours with no fever without fever-reducing medications, and symptoms have improved.
  • If asymptomatic and testing positive, 10 days must have passed since the test, and repeat testing depends on the availability of testing.
  • If you have been around someone with COVID-19, stay home for 14 days after exposure.
  • If you develop symptoms after testing, or after exposure, then follow the first recommendation listed.
  • For healthcare personnel (HCP), a test-based strategy is no longer recommended. If HCP have severe to critical illness or are severely immunocompromised, the recommended duration for work exclusion has been extended to 20 days after symptom onset (or for asymptomatic severely immunocompromised HCP, 20 days after initial positive test). However, because the majority of severely or critically ill patients no longer appear to be infectious 10 to 15 days after onset of symptoms, facilities operating under critical staffing shortages might choose to allow HCP to return to work after 10 to 15 days, instead of 20 days.
  • For HCP without severe disease or who are not severely immunocompromised, use the first criteria noted above.
  • The rationale behind these changes can be found here.

New Updates to HHS Provider Relief Fund FAQs Added on July 17

  • The following is from Hart Health: Not only has HHS updated its Provider Relief Fund FAQs, but HHS has also released additional information on the reporting requirements. According to the reporting requirements document, “[t]he reporting system will become available to recipients for reporting on October 1, 2020.” And “[d]etailed PRF reporting instructions and a data collection template with the necessary data elements will be available through the HRSA website by August 17, 2020.”
  • Updates include new organizations that did not bill Medicare in 2019, Medicaid and CHIP distributions, Enhanced Provider Relief Fund Payment Portal and specific revenue information required.
  • Revenue worksheet can be found here.

Yet Another Hand Sanitizer Recall

  • LIQ-E S.A. de C.V.’s Optimus Instant Hand Sanitizer due to potential presence of methanol. Read more details.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 20, 2020

Here are today's important updates:

Latest Updates From The Provider Relief Funds FAQs

May a health care provider that receives a payment from the Provider Relief Fund exclude this payment from gross income as a qualified disaster relief payment under section 139 of the Internal Revenue Code (Code)? (Added 7/10/2020)
No. A payment to a business, even if the business is a sole proprietorship, does not qualify as a qualified disaster relief payment under section 139. The payment from the Provider Relief Fund is includible in gross income under section 61 of the Code. For more information, visit the Internal Revenue Services' website. (Task Force Note: In our message released on 7/13, we noted that there is bipartisan support in Congress to correct this in the next coronavirus relief bill.)

Is a tax-exempt health care provider subject to tax on a payment it receives from the Provider Relief Fund? (Added 7/10/2020)
Generally, no. A health care provider that is described in section 501© of the Code generally is exempt from federal income taxation under section 501(a). Nonetheless, a payment received by a tax-exempt health care provider from the Provider Relief Fund may be subject to tax under section 511 if the payment reimburses the provider for expenses or lost revenue attributable to an unrelated trade or business as defined in section 513. For more information, visit the Internal Revenue Services' website.

Who is eligible to receive payments from the Provider Relief Fund? (Modified 7/14/2020)
Provider Relief Fund payments are being disbursed via both “General” and “Targeted” Distributions. To be eligible for the General Distribution, a provider must have billed Medicare fee-for-service in 2019, be a known Medicaid and CHIP or dental provider and provide or provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19, or prevented in the spread of COVID-19. HHS broadly views every patient as a possible case of COVID-19. U.S. healthcare providers may be eligible for payments from future Targeted Distributions. Information on future distributions will be shared when publicly available. All providers retaining funds must sign an attestation and accept the Terms and Conditions associated with payment.

I received an email from the Provider Relief Fund’s DocuSign application web portal informing me that my CARES Act Provider Relief Fund Application DocuSign submission (“envelop”) has expired. Does this mean I am not eligible to receive a General Distribution payment? (Modified 7/14/2020)
No. You received an automated email sent by DocuSign to providers who initiate one or more entries that were not completed or submitted. A number of providers opened duplicate entries in the DocuSign web portal, resulting in one or more of the entries (referred to as “envelopes” by DocuSign) becoming “orphaned” and incomplete. The expiration status of one DocuSign entry does not affect any other submissions by that provider. If an application was completed and submitted, no further action is required on the healthcare provider’s part.

I am a provider using financial statements to complete the application. In Field 10 where it asks for “gross revenue,” should I report net patient revenue, gross patient revenue, or total operating income from the financial statements? (Added 7/14/2020)
The amount reported in Field 10 should be net patient revenue plus other operating income. Net patient revenue is gross patient revenue less contractual adjustments, charity care/financial assistance, and bad debt expense. Other revenues, such as rental income, grants and contributions, joint venture income, and investment income, should be excluded from the amount reported in Field 10.

 

Face Coverings Do Work!

  • In this issue of the Morbidity and Mortality Weekly Report (MMWR), the authors report on a case of two hairstylists who worked for 8 and 5 days respectively with about 139 different clients while symptomatic with COVID-19.
  • Both of the hair stylists and their clients, per salon policy, wore face coverings or masks when working with clients.
  • None of the 139 clients reported symptoms after exposure and 67 were tested and were negative.
  • The index salon worker presumably passed the infection on to her co-worker during periods when they were conversing without masks or face coverings.
  • Both salon workers passed the infection on to family members and/or close contacts outside of work, when not wearing masks or face coverings.
  • Here is a great link to share with your patients about mask effectiveness.
     

Advocacy Opportunity: Protecting Access to Post-COVID-19 Telehealth Act

  • Members of the Congressional Telehealth Caucus have introduced HR 7663, the Protecting Access to Post-COVID-19 Telehealth Act. This bill would eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and establish the patient’s home as an eligible originating site, prevent a sudden loss of telehealth services for Medicare by authorizing CMS to continue reimbursement for 90 days beyond the end of the PHE, make permanent the disaster waiver authority, enabling HHS to expand telehealth in Medicare during all future emergencies and disasters, and require a study on the use of telehealth during COVID-19.
  • Members of the caucus who announced the introduction of the bill include Representatives Mike Thompson (CA-05), Peter Welch (VT-AL), Bill Johnson (OH-06), David Schweikert (AZ-06) and Doris Matsui (CA-06).
  • If one of these caucus members is your representative, contact them and thank them for introducing the bill. If not, then contact your representative and ask them to support the bill.
  • Learn more about advocacy during the Virtual Practice Management webinar this Thursday, July 23.

FDA Announces Additional Hand Sanitizer Recalls

  • 4e Brands North America is recalling several of their hand sanitizer products. All carry the BLUMEN Brand and include Advanced Instant Hand Sanitizer Clear, Advanced Hand Sanitizer, Clear LEAR Advanced Hand Sanitizer, Clear Advanced Hand Sanitizer, and Aloe Advanced Hand Sanitizer with 70 Alcohol.

Vaccine News

CDC Updates Guidance For Healthcare Workers About COVID-19 Testing

  • Updated July 14, this covers testing in healthcare settings, testing in communities, schools and workplaces.
  • Testing in healthcare settings includes testing for healthcare personnel.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 13, 2020

Here are today's important updates:

CDC Announces COVID-19 Social Media Toolkit

  • While not specific for allergists, the Centers for Disease Control and Prevention (CDC) has developed sample messages and graphics related to various COVID-19 topics for Twitter, Facebook and Instagram that we all might find useful for posting on our social media. Access the toolkit.
  • Other useful information from the CDC for posting includes recommendations on summer travel and visiting beaches and pools.

More on Asthma and COVID-19

  • publication in Nature this week showed markedly increased mortality with COVID-19 in those individuals with increasing BMI or non-white ethnicity, and further suggested that asthma patients who had received OCS in the past year also had increased mortality. However, when the data were limited to those in whom BMI, smoking history, and ethnicity were known (and, thus, could be controlled for), asthma with or without OCS use did not demonstrate a significant increased risk for death from COVID-19. Therefore, even with this paper, the preponderance of published data continues to demonstrate no increased severity or mortality with COVID-19 in asthma patients.

Provider Relief Fund FAQ Update

  • New questions and responses were added to the FAQs on July 8. Here are a couple that may be of interest to most:

How can a healthcare provider find more information on the status of their Provider Relief Fund payment or application? (Added 7/8/2020)
Providers should contact the Provider Support Line at (866) 569-3522 (for TTY, dial 711), if they have questions about the status of their payment or application. When calling, providers should have ready the last four digits of the recipient’s or applicant’s Tax Identification Number (TIN), the name of the recipient or applicant as it appears on the most recent tax filing, the mailing address for the recipient or applicant as it appears on the most recent tax filing, and the application number (begins with either “DS” or “CR”) if they have submitted an application in the Provider Relief Fun Payment Portal.

Will healthcare providers that have not had their TINs validated by the application deadline of July 20, 2020, be able to submit an application after that date? (Added 7/8/2020)
Yes. A healthcare provider must submit their TIN for validation by end of day July 20, 2020. If they receive the results of that validation after July 20, they will still be able to complete and submit their application.

COVID-19 Vaccine News

  • The National Institutes of Health (NIH) has launched a clinical trials network to test COVID-19 vaccines and other prevention tools.
  • Established by the National Institute of Allergy and Infectious Diseases (NIAID), the aim is to enroll thousands of volunteers in large scale clinical trials to test a variety of investigational vaccines and monoclonal antibodies. This COVID-19 Prevention Trials Network (COVPN) merges four existing NIAID-funded clinical trial networks, three of which have been doing HIV trials.
  • The vaccine effort will be led by Larry Corey, MD, of the Fred Hutchinson Cancer Research Center in Seattle and Kathleen M. Neuzil, MD, MPD, of the University of Maryland School of Medicine. The monoclonal antibody effort will be led by Myron S. Cohen, MD, of the University of North Carolina, Chapel Hill and David S. Stephens, MD, of Emory.
  • Learn more about this effort at the COVPN’s website. Interested individuals can sign up for a rolling clinical trial participant registry on the website (there are security-enhanced protections).

SARS-CoV-2 Transmission and the Risk of Aerosol Generating Procedures (AGPs)

  • In a Public Health Information Series article from the American Journal of Respiratory and Critical Care Medicine that was published online on June 30, the authors list sputum induction, nebulizer administration, pulmonary function testing and procedures that trigger cough reflex have the potential to generate respiratory aerosols.
  • The authors state that many institutions and professional societies recommend postponing non-urgent AGPs.
  • If AGPs have to be done, optimizing the patient environment (negative pressure rooms) and use of maximal PPE is recommended.
  • This publication reinforces the previous Task Force suggestions that these procedures are and remain high risk for in-office use.

Paycheck Protection Program (PPP) Tax Glitch

  • The American Medical Association (AMA) and others are urging Congress to correct some unintentional tax consequences related to PPP funds received by healthcare providers.
  • Congress specifically exempted PPP funds from taxation, but in drafting the bill, this exemption was not applied to “entities receiving PPP funds from maintaining their tax deductions for expenditures attributable to PPP funds”.
  • Fortunately there is bipartisan support to fix the problem in upcoming legislation.
  • Read more here.

CDC COCA Call This Thursday, July 16

  • CDC’s Clinician Outreach and Communication Activity (COCA) call this week will focus on Clinical Management of Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19.
  • Details are available here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 6, 2020

Here are today's important updates:

HHS Will Likely Extend Public Health Emergency

  • HHS spokesperson Michael Caputo tweeted that HHS intends to extend the COVID-19 PHE that is set to expire on July 25 by 90 days. Notable policies affected would include waivers of telehealth restrictions and no cost-sharing for COVID-19 testing.
  • This is only a tweet and a magazine quote, nothing official has been received so far.
     

More Provider Relief Fund FAQ Updates
This list is not inclusive of all updates, but highlights those of interest to the majority of allergists. Latest updates were made on 6/30/20.

Is a healthcare provider eligible to receive a payment from the Provider Relief Fund Medicaid Distribution even if the provider received funding from the Small Business Administration’s (SBA) Payroll Protection Program or the Federal Emergency Management Agency (FEMA)? (Added 6/25/2020)
Yes. Receipt of funds from SBA and FEMA for coronavirus recovery does not preclude a healthcare provider from being eligible for the Medicaid Distribution if the healthcare provider otherwise meets the criteria for eligibility and can substantiate that the Provider Relief Fund payments were used for increased healthcare related expenses or lost revenue attributable to COVID-19, so long as they are not reimbursed from other sources and other sources were not obligated to reimburse them.

What is the difference between the first Provider Relief Fund Payment Portal and the Enhanced Provider Relief Fund Payment Portal for the Medicaid Distribution? (Modified 6/25/2020)
The first Provider Relief Fund Payment Portal was used for providers who received a General Distribution payment prior to Friday, April 24. These providers were required to submit financial information in order to receive approximately 2% of gross revenues derived from patient care.

HHS has developed the new Enhanced Provider Relief Fund Payment Portal for providers who did not receive payments under the previous General Distribution, including those providers who bill Medicaid and CHIP (e.g., pediatricians, long-term care, and behavioral health providers.)

What are the audit requirements that need to be met to comply with Terms and Conditions of the Provider Relief Fund payments? (Added 6/30/2020)
HHS will have significant anti-fraud monitoring of the funds distributed, and the Office of Inspector General will provide oversight as required in the CARES Act to ensure that Federal dollars are used appropriately. HHS will notify recipients of applicable audit requirements in the coming weeks.

PPP Application Extended to August 8

  • There is still $120 billion dollars left in the PPP fund, so if for some reason you didn’t apply during the initial round, you have until August 8 to do so.

Myths and Rumors

  • Misinformation is always present in social media and in conversations among friends. This is even more true when we don’t know everything about a topic, such as COVID-19, although we have certainly learned a lot in the last few months. The CDC now has a webpage called "Stop the Spread of Rumors" that lists known facts about COVID-19. Refer your patients to this page for the most important facts about the disease.

Considerations for Travelers

  • It’s summertime and people are anxious to get out and vacation now that areas are re-opening. We should be encouraging people to remain at home as much as possible and limit non-essential travel, but if your patients are insistent, then refer them to this CDC website for information.

More Telehealth Legislation

  • Representatives Hern (NJ) and Sherrill (OK) have introduced legislation (HR 7391) entitled Protect Telehealth Access Act which would codify Medicare reimbursements for telehealth services including removal of the geographic and location restrictions. Encourage your legislators to co-sponsor if appropriate.

More Hand Sanitizers Containing Methanol

  • The FDA has discovered additional hand sanitizers that contain methanol and are listed at this website. Products include Hand sanitizer Gel Unscented 70% alcohol made by Grupo Insoma S.A.P.I de CV (Mexico); Mystic Shield Protection hand sanitizer, made by Transliquid Technologies (Mexico); Bersih Hand Sanitizer Gel Fragrance Free, and Antiseptic Alcohol 70% Topical Solution hand sanitizer both made by Soluciones Cosmeticas SA de CV (Mexico); and Britz Hand Sanitizer Ethyl Alcohol 70% made by Tropicosmeticos SA de CV (Mexico). Previously we reported on several products made by Eskbiochem SA de CV (Mexico).

American Academy Of Pediatrics (AAP) Releases Guidance for School Re-entry

  • Released on June 29, this guidance does offer some limited discussion on food allergies and treatment of students with asthma and the need for PPE for staff, but is likely to raise some concerns among parents of children with asthma and allergies. We encourage allergists to read it and be familiar with the statements made in the guidance. The guidance can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 26, 2020

Here are today's important updates:

HHS Provider Relief Fund FAQs Update

Additional information has been added to the Department of Health and Human Services (HHS) FAQs on this program. Some items of particular interest:

For how long are the Terms and Conditions of the Provider Relief Fund applicable? (Added 6/19/2020)
All recipients receiving payments under the Provider Relief Fund will be required to comply with the Terms and Conditions. Some Terms and Conditions relate to the provider’s use of the funds, and thus they apply until the provider has exhausted these funds. Other Terms and Conditions apply to a longer time period, for example, regarding maintaining all records pertaining to expenditures under the Provider Relief Fund payment for three years from the date of the final expenditure.

Can a healthcare provider that has not billed Medicaid/CHIP during the eligibility window (January 1, 2018 to December 31, 2019), but is a Medicaid/CHIP enrolled provider, apply for a Medicaid Targeted Distribution payment? (Added 6/19/2020)
Providers who are enrolled in Medicaid and were not eligible for a General Distribution payment may apply for a payment through the Enhanced Provider Relief Fund Payment Portal as long as they provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 after January 31, 2020. HHS broadly views every patient as a possible case of COVID-19. Providers that are not eligible for this distribution may be eligible for future allocations of the Provider Relief Fund.

HHS’ press release indicated that the eligibility timeframe for billing Medicaid or CHIP was January 1, 2018, to May 31, 2020, but the Medicaid/CHIP Provider Relief Fund Payment Forms and Guidance’s instructions indicates the timeframe is January 1, 2018, to December 31, 2019. Are healthcare providers that started billing Medicaid or CHIP in 2020 eligible to apply for these fund? (Added 6/19/2020)
No, new Medicaid or CHIP providers are not eligible to apply yet. Providers who began billing Medicaid/CHIP between January 1 and May 31, 2020 may be eligible for future allocations of the Provider Relief Fund.

HHS collected 2018 and 2019 Medicaid and CHIP provider data from state and federal sources, including corporate names, TINs, and payment amounts, and is using this data to validate Portal submissions. Data is not yet available for new providers who submitted claims between January 1 and May 31, 2020.

Is there a set period of time in which providers must use the funds to cover allowable expense or lost revenues attributable to COVID-19? (Added 6/22/2020)
HHS expects that providers will only use Provider Relief Fund payments for as long as they have eligible expenses or lost revenue. If, at the conclusion of the pandemic, providers have leftover Provider Relief Fund money that they cannot expend on permissible expenses or losses, then they will return this money to HHS. HHS will provide directions in the future about how to return unused funds. HHS reserves the right to audit Provider Relief Fund recipients in the future and collect any Relief Fund amounts that were used inappropriately. All payment recipients must attest to the Terms and Conditions, which require the submission of documentation to substantiate that these funds were used for increased healthcare related expenses or lost revenue attributable to coronavirus.

Telehealth Expansion

  • The AAAAI has been an active co-signer and originator of letters to the Centers for Medicare and Medicaid Services (CMS), HHS and Congress to continue the expansion of telehealth beyond the public health emergency (PHE), and ideally forever. Apparently CMS and HHS do not have the capability of extending these changes beyond the PHE, because it was the PHE that allowed for them. Congress, on the other hand, does have the legislative power to move this forward. On that note, Representative Liz Cheney (R-WY)  has introduced The Advancing Telehealth Beyond COVID-19 Act (H.R. 7338) to permit the Secretary of HHS to waive requirements relating to the provision of telehealth services under Medicare. This bill is co-sponsored by Representatives Greg Gianforte (R-MT), David Kustoff (R-TN) and Jason Smith (R-MO).
  • With passage of this bill, the Secretary would be able to waive the originating site and geographical limitations beyond the PHE period and would make permanent the telehealth coverage at Federally Qualified Health Centers and Rural Health Clinics.
  • The bill has the support of the Connected Health Initiative, a coalition of healthcare systems and industry. Contact your representatives and ask them to co-sponsor this bill.
  • CMS just released the Calendar Year (CY) 2021 Home Health proposed rule, which would update the home health prospective payment system (HH PPS) payment rates and wage index for 2021 and make permanent the changes to the home health regulations regarding the use of technology in providing services, as well as make revisions in response to the COVID-19 PHE interim final rule with a comment period. The rule discusses policies finalized in the CY 2020 HH PPS final rule regarding the permanent home infusion therapy services benefit for CY 2021. Details can be found here. The comment period for this proposed rule is open for 60 days, and the AAAAI and Hart Health will be considering comments.

NIH News

  • Experts identify steps to expand and improve antibody tests in COVID-19 response. More than 300 scientists and clinicians from the federal government, industry and academia published a report of their conclusions and recommendations on COVID-19 serology studies online in Immunity. More information is available here.

FDA Warns About Hand Sanitizers Containing Methanol

  • The Food and Drug Administration (FDA) advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol. Included products are: All Clean, Esk Biochem, CleanCare NoGerm and CleanCare NoGerm Advanced, Lavar 70 Gel, The Good Gel, and Saniderm Advanced. Read the FDA announcement.

More on Asthma and COVID-19

  • A research letter published online in CHEST on June 6 (Lieberman-Cribbin W, Rapp J, Alpert N, Tuminello S, Taioli E, The impact of asthma on mortality in COVID-19 patients, CHEST (2020), doi: https://doi.org/10.1016/j.chest.2020.05.575.) noted that among the 11,405 patients within the Mount Sinai Health System in New York City who had a COVID-19 related hospital encounter, “asthma was not associated with a higher risk of mortality” and the authors noted a low prevalence of asthma in the Mount Sinai Health System COVID-19 registry. Asthma was self-reported in this group.
  • Chhiba et al. (Chhiba KD, Patel GB, Vu THT, Chen MM, Guo A, Kudlaty E, Mai Q, Yeh C, Muhammad LN, Harris KE, Bochner BS, Grammer LC, Greenberger PA, Kalhan R, Kuang FL, Saltoun CA, Schleimer RP, Stevens WW, Peters AT, Prevalence and characterization of asthma in hospitalized and non-hospitalized patients with COVID-19, Journal of Allergy and Clinical Immunology (2020), doi: https://doi.org/10.1016/j.jaci.2020.06.010) in a retrospective study of 1,526 patients with confirmed COIVD-19 infection in the Northwestern University health system, noted a higher prevalence of asthma (14%) in this population, but asthma was not associated with an increased risk of hospitalization (RR of 0.96) after adjusting for age, sex, gender and co-morbidities, regardless of the use of inhaled steroids.
  • Killerby et al. (Killerby ME, Link-Gelles R, Haight SC, et al. Characteristics Associated with Hospitalization Among Patients with COVID-19 — Metropolitan Atlanta, Georgia, March–April 2020. MMWR Morb Mortal Wkly Rep 2020;69:790–794. doi: http://dx.doi.org/10.15585/mmwr.mm6925e1) analyzed data from 220 hospitalized and 311 non-hospitalized COVID-19 adult patients from six metropolitan Atlanta hospitals and associated clinics. Risk factors associated with hospitalization included older age, Black race, lack of insurance, male sex, smoking and obesity. Of note was that chronic respiratory disease was not a risk factor.

New Addition to AAAAI COVID-19 Resources Page

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 19, 2020

Here are today's important updates:

Provider Relief Fund Update From Hart Health Strategies
Additional information has been added to the Department of Heath and Human Services (HHS) FAQs on this program. Some items of particular interest:

Who is eligible to receive payments from the Provider Relief Fund? (Modified 6/12/2020)
Provider Relief Fund payments are being disbursed via both “General” and “Targeted” Distributions. To be eligible for the General Distribution, a provider must have billed Medicare fee-for-service in 2019 and provide or provided after January 31, 2020, diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. HHS broadly views every patient as a possible case of COVID-19. $50 billion will be disbursed in the General Distribution. A description of the eligibility for the announced Targeted Distributions can be found here. U.S. healthcare providers may be eligible for payments from future Targeted Distributions. Information on future distributions will be shared when publicly available. All providers retaining funds must sign an attestation and accept the Terms and Conditions associated with payment.

The Terms and Conditions for all Provider Relief Fund payments require recipients who receive at least $150,000 in the aggregate from any statute primarily making appropriations for the coronavirus response to submit quarterly reports to HHS and the Pandemic Response Accountability Committee. This requirement is from section 15011 of the CARES Act. What do providers need to do in order to be in compliance with this provision in the Terms and Conditions? (Added 6/13/2020)
Recipients of Provider Relief Fund payments do not need to submit a separate quarterly report to HHS or the Pandemic Response Accountability Committee. HHS will develop a report containing all information necessary for recipients of Provider Relief Fund payments to comply with this provision. For all providers who attest to receiving a Provider Relief Fund payment and agree to the Terms and Conditions (or retain such a payment for more than 90 days), HHS is posting the names of payment recipients and their payment amounts on its public website. HHS is also working with the Department of Treasury to reflect the aggregate total of each recipient’s attested to Provider Relief Fund payments on usaspending.gov. Posting these data meets the reporting requirements of the CARES Act. However, the Terms and Conditions for all Provider Relief Fund payments also require recipients to submit any reports requested by the Secretary that are necessary to allow HHS to ensure compliance with payment Terms and Conditions. HHS will be requiring recipients to submit future reports relating to the recipient’s use of its PRF money. HHS will notify recipients of the content and due date(s) of such reports in the coming weeks.

Why might a provider that bills Medicare fee-for-service not have received a payment from the initial $30 billion General Distribution? (Added 6/15/2020)
Some providers who did bill Medicare fee-for-service in CY2019 were not eligible for payment because either the provider is terminated from participation in Medicare or precluded from receiving payment through Medicare Advantage or Part D; is currently excluded from participation in Medicare, Medicaid, and other Federal health care programs; or currently has Medicare billing privileges revoked as determined by either the Centers for Medicare & Medicaid Services or the HHS Office of Inspector General.

If the provider’s TIN that was intended for payment identifies both a social security number of an individual Medicare provider and another Medicare provider’s employer identification number, that TIN was excluded from the General Distribution. Providers were also excluded from the General Distribution if there was incomplete banking information and/or personal contact information. HHS is working to determine eligibility for a General Distribution payment for those affected providers.

  • Many of the answers to the previous questions have been modified as of June 12, so be sure and double check questions that you checked prior to this date.

MedPAC Releases June 2020 Report to Congress

  • This report includes seven chapters focused on key issues related to the Medicare program and healthcare delivery. The portion applicable to allergists and a focus of AAAAI advocacy efforts relates to extension of the telehealth modifications arising out of the COVID-19 pandemic. Here is what the Commission had to say: “[p]olicymakers and researchers will need to evaluate the effects of recent legislative and regulatory changes on Medicare spending and outcomes to determine which policy changes are worth keeping in place once the pandemic has ended."

New CDC Guidelines on SARS-CoV-2 Testing

  • Revisions were made on June 13, 2020, to reflect the following: Changes noted were made in a retired document, “Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19),” which has been replaced by this Overview of Testing for SARS-CoV-2.
  • The document covers viral testing, antibody testing, and categories of people for viral testing (PCR): testing individuals with signs or symptoms consistent with COVID-19; testing asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission; testing asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings; testing to determine resolution of infection (i.e., test-based strategy for Discontinuation of Transmission-based Precautions, HCP Return to Work, and Discontinuation of Home Isolation); and public health surveillance for SARS-CoV-2.
  • U.S. testing data was updated on June 12. Total tests reported: 23,290,724 (7% of U.S. population). Total tests positive: 2,469,684 (11%). Percent positive varies by location. Check your location for relevant information.

NIH Announces All of Us Research Program to Seek New Insights into COVID-19

  • The All of Us research program is part of the National Institutes of Health (NIH), and it was announced on June 16 that they would be leveraging their significant and diverse participant base (350,000 participant partners across the United States) to seek new insights into COVID-19—through antibody testing, a survey on the pandemic’s impacts, and collection of electronic health record (EHR) information.
  • Data gathered through these activities will be accessible to approved researchers over time, in future releases of its data platform, the Researcher Workbench, now in beta testing.
  • Antibody testing will be done on 10,000 or more participants starting with samples from March 2020 and working backwards until positive tests are no longer found. Study collaborators include the Frederick National Laboratory for Cancer Research, the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, and Quest Diagnostics.
  • Participants will be asked to complete an online survey on physical and mental health effects of COVID-19 monthly until the pandemic ends.
  • More than 200,000 participants have shared their EHRs so far and the program is collecting relevant information related to COVID-19 symptoms and associated health problems.
  • Read more information here. New participants can still sign up at joinallofus.org.

UnitedHealthcare Extends COVID-19 Temporary Telehealth Expansion and Cost Share Waivers to September 30

  • This applies to Medicare Advantage, individual and fully insured group market health plans and Medicaid.
  • State-specific and Medicaid rules, regulations and limitations may apply.
  • Providers will be reimbursed at parity with in-person visits.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, June 15, 2020

Here are today's important updates:

CMS Announces Possible 2020 MIPS Relief

  • Hart Health Strategies informed the AAAAI that the Centers for Medicare and Medicaid Services (CMS) released a 2020 MIPS Exception Applications Fact Sheet on June 5, which discusses its MIPS Extreme and Uncontrollable Circumstances application-based and automatic exception policies.
  • Individual clinicians, groups, and virtual groups can submit an application to have their 2020 MIPS Quality, Cost, Improvement Activities, and/or Promoting Interoperability performance categories reweighted to 0% if they experience an extreme and uncontrollable circumstance outside of their control, including COVID-19, that prevents them from collecting data for an extended period of time, or that could impact their performance on cost measures. Applications may be submitted now through December 31, 2020.
  • Unlike 2019 MIPS data, where clinicians were automatically reweighted based on COVID-19, CMS has not yet identified any qualifying events that would qualify for automatic exceptions for the 2020 MIPS performance year (so you have to apply).

Considerations for Peanut OIT

  • As with most other procedures we have discussed, the ultimate decision on what to do in your practice is up to you. Given that, here are considerations that you should be aware of. Safety of the patient and staff and level of need related to medical decision making should be the guiding factors for your decision. Safety would involve consideration of the community spread, which determines the risk of a patient having asymptomatic or pre-symptomatic disease, availability of PPE and physical distancing in your office.
  • Based on data from the pivotal trials with Palforzia, the initial dose escalation visit had a low risk for anaphylaxis but the highest time of prolonged contact with staff and room utilization. The updosing visit had the highest risk for a systemic reaction with 3.5% of patients with a mild reaction, 5.1% with a moderate reaction, and 0.6% with a severe reaction. To be fair, the rates of mild and moderate systemic reactions in the placebo group were 1.4% and 2.1%, respectively. Moderate reactions are likely to involve respiratory or moderate GI symptoms, which would result in high risk exposure for staff.
  • Because of the potential for anaphylaxis and respiratory symptoms during these in-office visits, each office should consider the most appropriate form of PPE for staff involved in direct patient care and/or treatment should symptoms occur, including gown, gloves, respirator (N95 or equivalent mask) and eye protection.

From the NIH

  • National Institutes of Health (NIH) researchers have identified key genomic features that could differentiate SARS-CoV-2 from other coronaviruses that cause less severe disease. You can read more here.
  • There are now 365 clinical trials listed at clinicaltrials.gov related to COVID-19. These trials include anti-inflammatory treatments such as TNF inhibitors, kinase inhibitors and IL-6 inhibitors, convalescent plasma, nutritional supplements, and inhaled nitric oxide, to name a few. As we have stated before, at this time there is no evidence for an effective treatment for the virus other than the modest effect of remdesivir in shortening the time to clinical improvement.
  • Vaccines: Previous research on SARS-CoV-1 and MERS has led to more rapid development of potential vaccines against SARS-CoV-2. As part of Operation Warp Speed, the federal government is funding three vaccine candidates for Phase 3 trials this summer: mRNA-1273 developed by National Institute of Allergy and Infectious Diseases (NIAID) scientists and collaborators at Moderna, which directs cells to express a viral protein to elicit an immune response, starting in July; AZD1222, which uses a chimpanzee adenovirus vector to deliver a SARS-CoV-2 protein, being developed by Oxford’s Jenner Institute in partnership with AstraZeneca, starting in August; and BNT162, an mRNA-based vaccine being developed by BioNTech and Pfizer, which will start in September. A nice table and summary can be found in this article.
  • It is always important to remember that some vaccines have caused more harm than good, so safety is as important as effectiveness in the development of vaccines. Safety not only refers to direct adverse effects, but possible enhancement of disease with exposure to the virus. This article by Barney Graham at NIH provides a perspective on this issue.

HHS Medicaid Targeted Distribution

  • As noted in our last message, HHS has set up a new Portal for another $15 billion distribution of Provider Relief Funds to eligible clinicians who have NOT received payment from the $50 billion General Distribution, and must have directly billed Medicaid for healthcare-related services in 2018 or 2019 and provided patient care after January 1, 2020.
  • A section about the Medicaid Targeted Distribution has been added to the CARES Act Provider Relief Fund FAQs.

CDC Social Media Toolkit

  • The Centers for Disease Control and Prevention (CDC) has created a toolkit to help public health officials, health departments, community organizations, healthcare systems and providers to reach populations who may need COVID-19 prevention messaging in their native language.
  • It appears to be only available in Spanish at this time.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, June 9, 2020

Here are today's important updates:

Safe Use of Disinfectants

  • This week's Morbidity and Mortality Weekly Report (MMWR)—Gharpure R, Hunter CM, Schnall AH, et al. Knowledge and Practices Regarding Safe Household Cleaning and Disinfection for COVID-19 Prevention - United States, May 2020. MMWR Morb Mortal Wkly Rep. ePub: 5 June 2020. DOI: http://dx.doi.org/10.15585/mmwr.mm6923e2—describes the results of an opt-in internet survey report that indicated 39% of respondents were using these products in nonrecommended high-risk practices. Those who were using the products in this fashion were more likely to have an adverse health effect, but 25% of the group in general reported effects.
  • We all know that our patients are more sensitive to the effects of household cleaners and disinfectants, and allergists need to remind their patients about protection and proper use of these products in this time of heightened use. Here is a helpful one-page guide from the Environmental Protection Agency.

HHS Issues Amendment to Limit Liability

  • The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to provide liability immunity to healthcare providers against claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (except for claims of willful misconduct) against COVID-19 (as amended by the CARES Act).
  • The amendment states that: "Covered countermeasures are 1) any antiviral, any other drug, any biologic, any diagnostic, any other device (authorized for investigational or emergency use), any respiratory protective device (NIOSH approved), or any vaccine used a) to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or b) to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause; or 2) any device used in the administration of any such product, and all components and constituent materials of any such product."

HHS Updates FAQs on Provider Relief Funds on June 8

HHS Announces Enhanced Provider Portal, Relief Fund Payments for Safety Net Hospitals, Medicaid and CHIP Providers

  • On Wednesday, June 10, HHS will be launching an enhanced Provider Relief Fund Portal that will allow eligible Medicaid and CHIP providers to report their annual patient revenue. Payment to each provider will be at least 2% of reported gross revenue from patient care.
  • Eligible providers include clinicians that participate in state Medicaid and CHIP managed care organizations who have not yet received General Distribution funding from the Provider Relief Fund. More information can be found here.

NIH Announces Study That Identifies Potential Approach to Treat Severe Respiratory Distress in COVID-19

  • This is mentioned only because you may hear about it from patients or notice it in the news.
  • In a small, prospective off-label, proof-of-concept study of 19 hospitalized COVID-19 patients with low blood oxygenation and evidence of inflammation, eight of whom had been on ventilators, were treated with acalabrutinib, a BTK-inhibitor. Eight of the 11 patients on supplemental oxygen experienced a substantial drop in inflammation after one to three days and breathing improved. Four of the eight ventilator patients were able to be weaned off the ventilator. There was no comparator group. Results were used to inform the trial design for a randomized, controlled clinical trial in COVID-19 patients.
  • The study was published in the June 5 issue of Science Immunology and is available through open access.

More on Hydroxychloroquine

  • It was announced that studies on hydroxychloroquine in COVID-19 published earlier this year in Lancet and the New England Journal of Medicine (NEJM), both of which showed a lack of effect, were withdrawn due to problems with confirming the accuracy of patient data submitted via a registry.
  • A study was published in The BMJ on May 14 (BMJ 2020;369:m1849) from China on 150 hospitalized COVID-19 patients with mild-moderate disease who were enrolled in a multi-center, open-label randomized control trial of hydroxychloroquine plus standard care vs. standard care alone. The primary outcome measure was negative conversion of SARS-CoV-2 by day 28. There was no difference in conversion in the two groups. Adverse events were higher in the treated group, although only two had serious adverse events.
  • A study published in the NEJM on June 3 looked at the efficacy of hydroxychloroquine in over 800 patients as post-exposure prophylaxis after a high-risk or medium-risk exposure to a confirmed case of COVID-19 and noted no difference in rate of infection between treated and untreated groups.
  • Media headlines will likely grab the attention of our patients and we should be prepared to continue to offer guidance that there remains no evidence to support the use of hydroxychloroquine for prophylaxis or treatment of COVID-19.

Hazards of PPE

  • Prolonged use of PPE and hand hygiene during this pandemic can result in contact allergic/irritant dermatitis, pressure-related skin injury, acneiform eruptions, and moisture-associated skin irritation.
  • This pre-proof article (Desai SR, Kovarik C, Brod B, James W, Fitzgerald ME, Preston A, Hruza GJ, COVID-19 & PPE: Treatment and Prevention of Skin Conditions Related to the Occupational Use of Personal Protective Equipment, Journal of the American Academy of Dermatology (2020), DOI: https://doi.org/10.1016/j.jaad.2020.05.032) offers useful tips on how to deal with them.
  • Information summarized by InYoung Kim, MD, PhD, a reviewer, noted the following: For contact or irritant dermatitis due to masks, the authors recommend using alcohol-free barrier film wipes or thin foam dressings behind the ears and wearing N95 mask straps on the crown of the head to minimize contact with ears. To prevent and treat pressure-related facial skin injury, a thin hydrocolloid or foam dressing can be worn under surgical masks and an alcohol-free barrier wipe can be applied to areas of direct contact prior to wearing N95 masks. For those with skin damage, petroleum jelly (Vaseline) applied three to four times daily or hydrocolloid dressing applied to open wounds is recommended while not at work. To prevent acneiform eruptions and moisture-associated skin irritation, washing with noncomedogenic cleansers before and after work and taking breaks from the mask for 15 minutes every two hours are recommended. To mitigate irritant hand dermatitis and contact sensitization, emollients with either ceramides and/or petrolatum are encouraged, especially after washing hands.

EAACI Statement on Biologics in Times of COVID-19

Review on Prevalence of Asymptomatic SARS-CoV-2 Infection

  • A nice review was published in the Annals of Internal Medicine on June 3.
  • Key takeaway: We still don’t know for sure, but a “patchwork” of studies offer some insights.
  • It may be as high as 40 to 45%, but data has limits.

Now Is a Good Time to Reach Out

  • Several sources have noted a decline in emergency room use and scheduled visits due to patient concerns about risk, as well as a lack of availability for procedures, in-person visits and even telemedicine. Now that practices are resuming, allergists should reach out to their patients with chronic conditions such as severe asthma, food allergies and immune disorders and make sure that they are doing well. You can check and see if they are taking care of any additional chronic conditions as well.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 5, 2020

Here are today's important updates:

Great News! Paycheck Protection Program Flexibility Act Is Now Law

  • The Senate on Wednesday passed this act by unanimous consent, and the President signed it on June 5.
  • It was mentioned in earlier messaging, but to summarize the key points again: Borrowers would have 24 weeks instead of eight weeks to use the funds or until December 31, whichever comes sooner, and it lowers the amount they must spend on payroll to qualify for forgiveness to 60% from 75%.
  • More than $120 billion remains available for loans under the Paycheck Protection Program.
  • Some Senators noted that this bill does not allow for proportional forgiveness for payroll amounts less than 60%, but that may be changed with further legislative fixes.

HHS Updates CARES Act Provider Relief Fund FAQs 

  • This page is truly changing daily and you need to check it frequently. The following were added on June 2 and 3.

The Terms and Conditions state that Provider Relief Fund payments will only be used to prevent, prepare for, and respond to coronavirus and shall reimburse the Recipient only for healthcare-related expenses or lost revenues that are attributable to coronavirus. What expenses or lost revenues are considered eligible for reimbursement?

The term “health care related expenses attributable to coronavirus” is a broad term that may cover a range of items and services purchased to prevent, prepare for, and respond to coronavirus, including:

  • supplies used to provide healthcare services for possible or actual COVID-19 patients;
  • equipment used to provide healthcare services for possible or actual COVID-19 patients;
  • workforce training;
  • developing and staffing emergency operation centers;
  • reporting COVID-19 test results to federal, state, or local governments;
  • building or constructing temporary structures to expand capacity for COVID-19 patient care or to provide healthcare services to non-COVID-19 patients in a separate area from where COVID-19 patients are being treated; and
  • acquiring additional resources, including facilities, equipment, supplies, healthcare practices, staffing, and technology to expand or preserve care delivery.

Providers may have incurred eligible health care related expenses attributable to coronavirus prior to the date on which they received their payment. Providers can use their Provider Relief Fund payment for such expenses incurred on any date, so long as those expenses were attributable to coronavirus and were used to prevent, prepare for, and respond to coronavirus. The Department of Health and Human Services (HHS) expects that it would be highly unusual for providers to have incurred eligible expenses prior to January 1, 2020.

The term “lost revenues that are attributable to coronavirus” means any revenue that you as a healthcare provider lost due to coronavirus. This may include revenue losses associated with fewer outpatient visits, canceled elective procedures or services, or increased uncompensated care. Providers can use Provider Relief Fund payments to cover any cost that the lost revenue otherwise would have covered, so long as that cost prevents, prepares for, or responds to coronavirus. Thus, these costs do not need to be specific to providing care for possible or actual coronavirus patients, but the lost revenue that the Provider Relief Fund payment covers must have been lost due to coronavirus. HHS encourages the use of funds to cover lost revenue so that providers can respond to the coronavirus public health emergency by maintaining healthcare delivery capacity, such as using Provider Relief Fund payments to cover:

  • Employee or contractor payroll
  • Employee health insurance
  • Rent or mortgage payments
  • Equipment lease payments
  • Electronic health record licensing fees

All providers receiving Provider Relief Fund payments will be required to comply with the reporting requirements described in the Terms and Conditions and specified in future directions issued by the Secretary. HHS will provide guidance in the future about the type of documentation we expect recipients to submit on the CARES Act Provider Relief page.

  • If you were not able to submit your revenue information by June 3, you will not be considered for a portion of the $20 billion remaining funds.

CMS Summary of Policies in the Calendar Year 2020 Medicare Physician Fee Schedule Public Health Emergency Interim Final Rules

  • The Centers for Medicare and Medicaid Services (CMS) Medicare Learning Network has established a website that summarizes, in one place, the changes made over this public health emergency. It can be found here.
  • Topics include the multiple facets related to telehealth. We advise bookmarking this page for future reference.

House Energy and Commerce and Senate Finance Commitees Query HHS About Support for Medicaid Providers

  • Bipartisan leadership of these committees are concerned about HHS’ timeline to release a dedicated tranche of these funds for Medicaid-dependent practitioners, as well as the level of funding.

CDC Updates FAQs on K-12 Schools and Child Care Centers Relative to Children with Asthma

  • The Centers for Disease Control and Prevention (CDC) has released new FAQs regarding students going to school. In these FAQs it is suggested that peak flow meters could be used, as forceful exhalation “is not considered an aerosol-generating procedure”. The CDC does acknowledge that people with asthma may cough when performing a forceful exhalation. They also reference a meta-analysis (PLoS One. 2012; 7(4): e35797. doi: 10.1371/journal.pone.0035797) that suggests that aerosols generated from nebulizers may not be infectious. The supporting data for this is very poor, however. There were three studies that involved nebulization, all were retrospective. One found the relative risk of infection from SARS-CoV-1 to be 1.11-9.42 for using a nebulizer (Emerg Infect Dis. 2004 Feb; 10(2): 251–255. doi: 10.3201/eid1002.030838). Another reported a patient who infected a group of medical students, with reduced transmission when a nebulized beta-agonist was administered (Emerg Infect Dis. 2004 Feb; 10(2): 269–276. doi: 10.3201/eid1002.030452). The third examined health care workers and found none of nine individuals exposed to a nebulizer developed SARS (PLoS One. 2010; 5(5): e10717. doi: 10.1371/journal.pone.0010717). The CDC recommends wearing a mask, gloves and eye protection when assisting with nebulizer therapy or peak flow meter use, but the COVID-19 Response Task Force does not believe this is sufficient evidence to not wear full PPE (gown, gloves, N95 mask and eye protection) when performing nebulized therapy, and we question the overall safety of peak flow usage in public without wearing gloves, mask and eye coverage as recommended by the CDC.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, June 2, 2020

Here are today's important updates:

HHS Announces Providers Need to Take Action by June 3

  • The Department of Health and Human Services (HHS) has caused some confusion related to the Provider Relief Fund with its 90 day extension announced previously. On the HHS CARES Act Provider Relief Fund website, it now states: Providers need to take action by June 3, 2020. Providers must submit revenue information to the General Distribution Portal by June 3, 2020, to be considered for an additional payment from the Provider Relief Fund $20 billion General Distribution. Once providers submit their revenue information by June 3, 2020, if deemed qualified for additional payment, providers will then have 90 days from receipt of payment of the additional General Distribution funds to agree to the program Terms and Conditions.
  • We realize that some of you may have received an email from HHS informing you of this, but we want to be sure you are aware.
  • HHS has also updated the FAQs on this website effective May 26 and May 29. These updates include answers to questions about actions needed to take after receiving a payment, how to return a payment, what to do if a payment is greater than expected or received in error, the definition of Executive Level II pay ($197,300), how HHS will recoup funds from overpayment or payments in error, and other questions related to additional General Distribution, use relative to Paycheck Protection Program funds, and so on. We encourage you or your business manager to review these FAQs for information relevant to your practice.

CMS Updates FAQs on Medicare FFS Billing

  • View the FAQs.
  • Some changes were made related to Fee-for-Service (FFS) billing, including telehealth, on May 27.
  • Changes in telehealth related to the CARES Act are not included.
  • This is a long document, but most of the FAQs of interest to the practicing allergist start on page 35 and 46.

CMS Issues Final CY Medicare Advantage Part D Changes

  • The Centers for Medicare and Medicaid Services (CMS) has codified existing Part C and D program policies related to network adequacy, which includes encouraging and accounting for certain telehealth providers (i.e., Dermatology, Psychiatry, Cardiology, Otolaryngology, Neurology, Ophthalmology, Allergy and Immunology, Nephrology, Primary Care, OB/GYN, Endocrinology, and Infectious Disease) in Medicare Advantage (MA) plans.
  • Read more in this fact sheet.

CDC Updates Guidance on When You Can be Around Others After You Had or Likely Had COVID-19

CDC Provides New Guidance for Schools and Day Camps, As Well As Households Living in Close Quarters

UnitedHealthcare Announces Updates to Their Telehealth Policies

  • Extends waiver for originating site for MA to September 30. For Medicaid, will follow state regulations, and for commercial insurance to July 24 (end of current public health emergency).
  • For MA plans, reimbursement for telehealth will only apply to audio-video services. Telephone only visits must be billed using telephone codes. For commercial insurance, providers can bill for telehealth services for audio-video or audio only.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 29, 2020

Here are today's important updates:

What's New in Diagnosis and Treatment

  • There is an interesting collaborative study with Adaptive Biotechnologies and Microsoft (ImmuneRACE), which maps the genetic material of all immune receptors in the blood and then uses machine learning to determine those that respond to SARS-CoV-2 in patients with known exposure, current infection or prior infection. This study should enhance our understanding of the specific immune response, and thus enable earlier and more accurate detection of COVID-19.
  • As a reminder, you can get the latest on research on COVID-19 at this page.
  • Information on testing supplies, tests, and Emergency Use Authorizations can be found here.
  • The Centers for Disease Control and Prevention (CDC) has issued new guidance on serologic testing.

Telehealth Parity

  • A major focus of advocacy efforts by the AAAAI, American Medical Association, and other medical societies has been on the extension of parity between in-person visits and telemedicine visits. Research on the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services (HHS) websites indicate that a public health emergency (PHE) declaration is in effect for 90 days after the announcement, unless specifically stated that the PHE is over. The last renewal of the PHE by HHS was on April 20. This would indicate that the PHE, and all the waivers, flexibility, and regulations that were to be in effect as long as the PHE lasts, should continue until at least the third week in July, unless the PHE is declared over. Check your insurer’s website to see if they have also extended their rules with respect to parity for virtual visits. As an example, Cigna changed their website to indicate that they would continue to offer their interim policies concerning virtual care until July 31.
  • In fact, the AAAAI is hosting a Virtual Advocacy Day on Wednesday, June 3, and one of the three priority issues is extending and strengthening access to telehealth beyond the COVID-19 PHE. The other two issues are food allergy research funding, and allergy and asthma management for school-aged children. Watch your email for instructions on how you can participate in AAAAI's June 3 Virtual Advocacy Day, and as always, you can contact advocacy@aaaai.org with any questions.

Another Update from HHS on the Provider Relief Fund

  • On May 22, HHS announced a 45 day extension for providers who are receiving payments from the Provider Relief Fund to accept the terms and conditions. That means that providers have a total of 90 days to respond or return the funds.

Changes Proposed for PPP

  • The House passed the Paycheck Protection Program Flexibility Act sponsored by Representatives Chip Roy (R-TX) and Dean Phillips (D-MN) on Wednesday by a vote of 417-1, which proposes to allow forgiveness for expenses beyond the eight week covered period, remove the 75/25 rule, eliminate the restriction limiting the loan terms of two years, and expand forgiveness for businesses unable to rehire due to the continuing pandemic. This bill would not change the allowable expenses under the current Paycheck Protection Program (PPP). Also under consideration is the TRUTH Act. This legislation would require the Small Business Administration to provide details on loans made over $2 million and justify policy decisions like the recent slashing of Economic Injury Disaster Loan limits, ensuring transparency and accountability from the agency while protecting the privacy of recipients of smaller loans.
  • On a separate front, Representative Abby Finkenauer (R-IA) introduced the Protecting Paychecks and Employees Act, which would allow small businesses to use funds from PPP loans on personal protective equipment (PPE) for their employees. The bill would also eliminate the requirement that small businesses use 75% of loan proceeds on payroll.

FDA Announcement on Policy Changes Regarding Food Labeling

  • Hopefully you read the email blast from AAAAI President Mary Beth Fasano, MD, MSPH, FAAAAI, concerning this announcement from the Food and Drug Administration (FDA), which came out May 26. If not, the FDA established a temporary policy regarding certain food labeling requirements based on requests from the food industry about the need for omissions or substitutions of minor ingredients in the manufacture of some foods, and the inability to make label changes for these substitutions without slowing food distribution. This came about as the result of shortages in some food ingredients.
  • This change has led to several announcements/concerns expressed by food allergy advocates concerning risk to food allergic patients.
  • The allergist should be aware that the FDA policy guidance recommends against substitutions for the eight major food allergens, gluten, sulfites, or "other foods known to cause sensitivities" (sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard). Substitutions will be allowed only for ingredients present at 2% or less, spices, fats and oils, artificial flavors, colors, or acids.
  • The AAAAI has sent a letter to the FDA emphasizing the potential impact of these changes and the need to ensure that the guidance issued is followed for the sake of the food allergic patient.
  • Experts from the AAAAI feel that these changes are not likely to have any significant impact on our food allergic patients, with rare exceptions, and the allergist should be reassuring to their patients and/or parents.
  • Patients that might be impacted could include FPIES infants with severe rice sensitivity or perhaps some EoE patients, since their trigger foods are not excepted, but the 2% limit is reassuring.

Guidance on Spirometry and Peak Flow Measurements

  • Click to View as a PDFThe Task Force has received a few letters related to our Suggestions or Considerations for Resuming Practices document and our statement in that document that spirometry and peak flow measurements are “high risk” procedures. We want to reiterate that such considerations are fluid and affected by your local situation. We assumed that any patient, even with screening, could be an asymptomatic or pre-symptomatic infected patient since the availability and reliability of testing remains in question and the incidence of asymptomatic infected patients is likely to be unknown. We also know that current PPE supply is variable and an office may not be able to adequately protect their staff. The CDC has provided some conflicting information. On the one hand, they state in their guidance for schools that peak flow measurements are not considered a risk because forced exhalation is not a method of infection transmission, but then state to consider the use of PPE in such situations. In their guidance on aerosol-generating procedures, they state that the data is lacking and they are unable to provide a list of aerosol-generating procedures.
  • The Task Force remains concerned about spirometry and forced exhalation being potential avenues of viral transmission. A potential example of this is a published report (Hamner L, Dubbel P, Capron I, et al. High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice — Skagit County, Washington, March 2020. MMWR Morb Mortal Wkly Rep 2020;69:606–610. DOI: http://dx.doi.org/10.15585/mmwr.mm6919e6) where a single infected and symptomatic individual appears to have infected 32 (confirmed, and a potential additional 20) other individuals (out of 61 total people in the room) during a 2.5 hour choral practice (where face masks and physical distancing were NOT practiced).
  • Also, spirometry and peak flows in patients with bronchial hyperresponsiveness often results in cough, and coughing has been shown to be a route for infection transmission.
  • Therefore, at this time, the Task Force has not changed its opinion that these procedures are high risk, but recognizes that each practice is different with respect to physical structure, knowledge of their community, and availability of PPE. Ultimately, the decision to perform these tests rests with the individual practitioner.
  • Alternative approaches to performing these tests in the office include providing a patient with a peak flow meter to be used at home before a visit, or utilizing one of the home FEV1 monitoring systems.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 22, 2020

Here are today's important updates:

From the CDC

  • As the community around us “re-opens” and we consider resuming practice, allergists need to remind their patients, particularly those most vulnerable, that COVID-19 spreads easily in groups. There are myriad examples, but specifically outbreaks reported in the Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) include spread in a church gathering and a choir practice. This doesn’t just affect older patients. In the church gathering, the largest infected group were 18 to 64-year-olds.
  • Multisystem inflammatory syndrome slides and the recorded presentation can be obtained here. This Clinician Outreach and Communication Activity call presents data and treatment information on two cohorts with this disorder, one from New York and the other from the UK. Symptoms varied in the two cohorts except for fever, but most patients in both presented with GI symptoms, with a majority having shock and myocardial involvement, with markedly elevated inflammatory markers. Treatment varied between the two groups, but IVIG and systemic steroids were used in a majority of patients. Prognosis was pretty good, only one death among 60+ patients.
  • Information for schools newly released by the CDC has some FAQs that are important for allergists in counseling parents of school-aged children. The two questions of note relate to management of an asthma attack in school and use of a school stock albuterol inhaler.

State Level Information

  • Many members have asked for information on COVID-19 regulations at the state level. Although the AAAAI doesn’t track state regulations on a consistent basis, here are two excellent websites that do track each state, with interactive, ongoing information: the National Governors Association and the Council of State Governments. Here is a resource from the American Academy of Pediatrics specifically on telehealth and state plans.

Interstate Medical Practice

  • For some time now, although it's been recently increasing, states have formed interstate licence compacts which offers a pathway to licensure for practitioners who wish to practice in multiple states. The Centers for Medicare & Medicaid Services (CMS) has determined that these compacts will be treated as valid, full licenses for the purpose of meeting CMS’ federal license requirements. CMS notes that MACs will accept CMS-855 enrollment applications from providers reporting an interstate license compact.

COVID-19: Payment for Diagnostic Laboratory Tests

  • As testing becomes more available and allergists are considering resuming practice, CMS released additional clarification on May 19. Healthcare providers may bill Medicare and other health insurers for SARS-CoV-2 tests performed on or after February 4 using HCPCS code U0001 for tests developed by the CDC, or U0002 for non-CDC lab tests. Health providers can also bill Medicare for tests using these CPT codes: 87635 for infectious agent detection by nucleic acid tests for dates of service on or after March 13, or 86769 and 86328 for serology tests for dates of service on or after April 10.

Neutralizing Antibody

  • You have undoubtedly heard about this one, in the search for treatment for COVID-19. Published in Nature on May 18, the researchers identified several monoclonal antibodies from memory B cells from a patient who had survived SARS in 2003, several of which were directed at targets on the coronavirus spikes. One of the antibodies appeared to be particularly effective at targeting and disabling the spike protein that promotes SARS-CoV-2 entry into cells in vitro. Combining this antibody with other weaker antibodies appeared to enhance the effect. The research team still needs to show that this works in living systems. This has the potential to be used in prophylaxis or treatment.

Serologic Testing and Herd Immunity

  • The World Health Organization director announced recently that only about 20% of the population, even in the hardest hit areas, had coronavirus antibodies. While there remain questions about the accuracy of testing, the number of patients with immunity to this virus would need to approach 70% of the population to achieve herd immunity, according to the Johns Hopkins Bloomberg School of Public Health.

Latest Updates for HHS Provider Relief Fund

  • The Department of Health and Human Services (HHS) has once again updated the FAQs on the CARES Act Provider Relief Fund, with many updates on May 20.
  • Modified or new questions: What action does a provider need to take after receiving a payment? How can I return a payment? Is there a public list of providers and the payments they received? What should I do if a General Distribution payment is greater than expected or received in error? In the case of a merger of a provider entity (billing TIN) into another entity (billing TIN), or the consolidation of two or more entities (each with a billing TIN), resulting in the creation of a new entity (single billing TIN) between January 1, 2018, through January 31, 2020, how should the entities apply? How should an organization currently undergoing a change in ownership to purchase a practice report revenue in its application? An organization that sold part of a practice in 2019 or January 2020 received a payment under the General Distribution that reflected the 2019 Medicare fee-for-service billing of that part of the practice. Can it return a portion of the payment for the part of the practice it no longer owns? A parent entity submitting an application for a General Distribution payment from the $20 billion payment tranche has more than 20 subsidiaries with billing TINs. How should it complete the application in the Provider Relief Fund Payment Portal?
  • Probably most important to the majority of our members is: What should I do if a General Distribution payment is greater than expected or received in error? It states: Providers that have been allocated a payment must sign an attestation confirming receipt of the funds and agree to the Terms and Conditions within 45 days of payment via ACH or within 60 days of check payment issuance. If a provider believes it was overpaid or may have received a payment in error, it should reject the entire General Distribution payment and submit the appropriate revenue documents through the General Distribution portal to facilitate HHS determining their correct payment. If a provider believes they are underpaid, they should accept the payment and submit their revenues in the provider portal to determine their correct payment.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 18, 2020

The AAAAI COVID-19 Response Task Force has created a list of Suggestions or Considerations for Resuming Practices that includes staff safety protocols, practice space logistics, and a classification of low, medium and high-risk procedures.

Click the image to download a PDF that you can easily print or share. You can also read a full text version.


Here are today's important updates:

HEROES Act Preliminary Information

Here are the key health policies in H.R. 6800, which still faces scrutiny in the Senate and with the administration:

  • Provides $75 billion in grants to state, local, tribal and territorial health departments to support testing, contact tracing, isolation or quarantine while requiring the Centers for Disease Control and Prevention to establish a coordinated evidence-based testing system, and creates centralized national reporting of testing capacity and results.
  • Provides stable and affordable health coverage for millions with subsidies for the cost of COBRA premiums, allows state Medicaid programs to cover COVID-19 treatment for uninsured, and establishes special enrollment periods for Affordable Care Act exchanges.
  • Ensures all can access COVID-19 treatment without concern for cost by eliminating cost sharing for Medicaid, Medicare, TRICARE, VA and private health insurance, requires coverage of items and services related to treatment, and mandates coverage for a vaccine with no cost-sharing.
  • Stabilizes and reinforces the public health system by making supply chain improvements, investing in vaccine manufacturing capacity, and requires the Department of Health and Human Services (HHS) to create a distribution and administration plan, improves national stockpile management, authorizes funding for the Medical Reserve Corps, and establishes a loan repayment program to enhance recruitment of a public health workforce.
  • Supports hospitals and frontline healthcare providers by appropriating an additional $100 billion into the Provider Relief Fund and provides clear guidance on efficient and equitable distribution, increases payments to facilities that serve a high proportion of Medicaid patients, improves the Accelerated and Advance Payment Program (which is currently on hold) by lowering the interest and extending the payment period.
  • Supports state governments and their Medicaid programs by increasing the Federal Matching Assistance Percentage by 14% through June 30, 2021.
  • Additional actions: provides nearly $1 trillion to state, local, territorial and tribal governments to pay first responders, healthcare workers and teachers, provides a second round of economic impact payments of $1,200 per family member, enhances the employee retention tax credit, strengthens the Paycheck Protection Program (PPP) and provides an additional $10 billion for the Economic Injury Disaster Loan (EIDL) program, extends the weekly $600 federal unemployment payments through January, and adds $175 billion in new rent and mortgage assistance.
  • Changes to PPPExtends the authorization period to December 31 from June 30, or sooner if funds are exhausted. The Small Business Administration (SBA) must set aside at least 25% of PPP funds to guarantee loans issued to eligible recipients with 10 or fewer employees. Any amounts returned from canceled loans would be reserved to guarantee new loans issued to recipients with 10 or fewer employees. Expands the PPP eligibility rules to cover nonprofit organizations of any type or size including 501(c)(6) trade associationsExtends the forgiveness period to cover costs incurred over 24 weeks or through December 31, whichever comes first (was 8 weeks). Bars the SBA from limiting loan forgiveness for expenses other than payroll (including PPE), expands forgivable expenditures to include payments on refinanced disaster loans and interest payments on additional types of debt, and maintains forgiveness amounts for businesses that were unable to rehire employees or resume business levels as of February 15, or find similarly qualified workers by the end of the year.
  • Accelerated and Advance Payment Programs modified and interest rate reduced to 1%. Provides up to one year before claims are offset and sets a recoup percentage maximum of 25% per claim, with up to two years for the outstanding balance to be paid.
  • And much, much more that we will report on as we can.
  • REMEMBER, THIS BILL STILL HAS TO PASS THE SENATE AND BE SIGNED BY THE PRESIDENT, WHO HAS ALREADY DECLARED IT DOA.

SBA and Treasury Release PPP Loan Forgiveness Application 

  • We still have to abide by the current regulations, even though they may change. Here is the website for this application.

Update on CMS Ruling on Telephone Payment

  • Just in from the American Medical Association (AMA): The Centers for Medicare & Medicaid Services (CMS) made the new payments for telephone-only visits retroactive to March 1. CMS specifically told the AMA that the MACs will be expected to automatically adjust retroactive changes to the claim payment, so practices will not have to resubmit the claims. CMS also noted that it will take time to implement these changes, and recommends that practices give their MACs some time to catch up and then check with the MACs if they have questions. Apparently CMS implemented a new Physician Fee Schedule on April 30 for these codes.

Update on HHS Provider Relief Fund

  • Many questions and answers have been listed on this webpage on May 12 and 14.
  • There are too many to list here, but there are a couple of highlights and corrections related to previous statements. The distribution of the additional $20 billion that was discussed in an earlier email is proportional to a provider’s share of 2018 (or the latest completed tax year) NET patient revenue. We previously reported this as gross revenue. This revenue is regardless of the provider’s payer mix. Total payments are determined based on the lesser of 2% of a provider's net patient revenue for 2018 (or most recent completed tax year) or the sum of incurred losses for March and April. If your initial distribution was at least 2% of annual patient revenue, you will not receive additional payments. You can estimate your total payments from the $50 billion Provider Relief Fund using this equation: (Individual Provider Revenues/$2.5 trillion) x $50 billion = expected combined general distribution.

More on Asthma and COVID-19

  • A pre-print paper to be published in JACI: In Practice, which is a single center report with a small number of subjects, found that those with self reported asthma who were intubated for COVID-19 had a longer intubation course than those without asthma. Interestingly, this was seen only in those younger than age 65, but again there were a small number of subjects.

More on Serologic Testing

  • The Food and Drug Administration (FDA) has published a webpage on the current EUA-approved serologic testing with respective sensitivity and specificity numbers for each test. A caveat is that the data is from the company's own testing and the details of the tested population is not given.
  • The AMA has published very useful guidance on Serological Testing for SARS-CoV-2 Antibodies that you can print and share with colleagues and patients.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, May 12, 2020

Here are today's important updates:

United Healthcare News

  • United Healthcare announced on May 8 that they are waiving all cost shares (copays, coinsurance and deductibles) for their Medicare Advantage members for all covered office-based professional services performed by both primary care and specialists starting May 11 until at least September 30.
  • Coverage for telehealth mirrors the recent Centers for Medicare & Medicaid Services (CMS) waivers and new interim rule.

Updated FAQs on HHS Provider Relief Fund

  • The Department of Health and Human Services (HHS) has released updated FAQs related to the CARES Act Provider Relief Fund, which can be accessed here.
  • Any provider who has already received a payment from the Provider Relief Fund as of 5:00 pm EST Friday, April 24 can and should apply for additional funding via the Provider Relief Fund Application Portal.
  • Providers who have not received funding as of 5:00 pm EST Friday April 24 are NOT eligible to use the Provider Relief Fund Application Portal, HOWEVER these providers may still be eligible for payments from the Provider Relief Fund through targeted distributions for care of the uninsured, areas of high impact, or rural health care. Descriptions are noted here.
  • To be eligible for the general distribution, a provider must have billed Medicare in 2019 and provide or provided after January 31, 2020, diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. HHS broadly views every patient as a possible case of COVID-19.

NIH and COVID-19

  • At the Senate HELP Committee hearing on May 7, Francis Collins, MD, PhD, director of the National Institutes of Health (NIH), announced that they had started a partnership with 18 pharmaceutical companies called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). He also announced the recent Rapid Acceleration of Diagnostics (RADx) project. This project is engaging scientists across the country to improve current tests and advance completely new technologies, ideally for point of care testing. More information on that project can be found on the NIH website here.

Food Allergy Issues Again

  • Interim Guidance for Administrators of US K-12 Schools and Child Care Programs from the Centers for Disease Control and Prevention (CDC) recommends avoiding mixing students in common areas and includes the example of having students eat breakfast and lunch in the classrooms. The allergist needs to be sure to discuss this issue with food allergic children and their parents.
  • The Food Allergy & Anaphylaxis Connection Team (FAACT) has written to the director of the CDC asking for exceptions for classrooms with food allergic students.

What Are Other Practices Doing?

  • The Regional, State and Local Allergy, Asthma and Immunology Societies Assembly has provided us with some feedback on what practices are doing around the country. Responses from New Jersey and Texas indicate that most practices are doing telemedicine. Some are seeing a few patients in person and most continue allergy shots. All have seen a reduction in revenue and income, some approaching 50%. Most are not performing any pulmonary function procedures. It is important to understand that New Jersey is one of the hot spots and Texas is an early re-opening state, so the approach is expected to be somewhat different. Most offices require staff and patients to wear masks or face coverings, and the amount of PPE the staff is wearing depends on the supply. Some have placed “sneeze guards” at the check-in area, and one practice retrofitted waiting room chairs with table paper! Some are trying to keep their staff employed with the help of Small Business Administration loans, but many others have laid off or furloughed staff.
  • Academic centers in Chicago/the Midwest and Seattle are announcing pay cuts across the board for leadership and staff varying from 10-20%. In addition, they are trimming expenses, hires and capital projects.
  • Many academic centers have also removed academic enrichment funds to be used for travel/attendance at professional meetings and have placed travel restrictions pertaining to both professional and personal trips.

What Are Other States Doing?

  • Questions have come up about state regulations concerning telehealth, licensing, etc. Please visit the AAAAI COVID-19 advocacy page and select the State Resources link within the set of continually updated links from AAAAI’s professional advocacy team, Hart Health Strategies. Make sure you clear your browser cache before each visit to access the latest news.

Keep regularly visiting the AAAAI COVID-19 resources page, and if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 8, 2020

Here are today's important updates:

CDC Revises Ending Isolation Recommendations

  • In the context of community transmission where continued testing is impractical, the available evidence is nicely summarized on this webpage. The Centers for Disease Control and Prevention (CDC) has revised their terminology and recommendations to establish the end of isolation. They do attach a disclaimer that the practical application of a symptom-based strategy cannot prevent all infections, but the data they present is pretty reassuring that these recommendations are safe.
  • Symptoms-based strategy: For persons recovered from COVID-19 illness, isolation should be maintained for at least 10 days after illness onset AND at least three days (72 hours) after recovery.
  • Either a test-based strategy or a symptom-based strategy with more stringent requirements (not specified) may be used for recovered persons for whom there is low tolerance for post-recovery SARS-CoV-2 shedding and infectious risk because they are: 1) persons who could pose a risk of transmitting infections to vulnerable persons at high risk for mortality from COVID-19 or persons who support critical infrastructure; 2) persons normally residing in congregate living facilities (includes ships); 3) persons who because they are immunocompromised may have prolonged viral shedding.
  • Recommendations for immunocompromised patients have not changed from March 16. When possible, a test-based strategy is recommended: resolution of fever without fever-reducing medication AND improvement in respiratory symptoms AND negative results of a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approved molecular assay for COVID-19 from at least two consecutive upper respiratory swab specimens collected >/=24 hours apart.
  • For healthcare personnel (HCP), there are approaches, one for symptomatic HCP with suspected or confirmed COVID-19, which includes either the symptom-based or test-based strategies outlined above. The other is for asymptomatic confirmed COVID-19 HCP where either a time-based strategy where the HCP is excluded from work until 10 days have passed since the date of their first (+) COVID-19 test or a test-based strategy as noted above. If the HCP develops symptoms, then revert to the symptom-based or test-based strategy for symptomatic HCP.
  • HCP should wear a mask at all times after returning to work until the symptoms have completely resolved or they are back to baseline and self-monitor for symptoms.

CMS New Interim Final Rule - Key Takeaways for Allergists

  • Time used for level selection for E/M telehealth visits: The Centers for Medicare & Medicaid Services (CMS) is finalizing on an interim basis, for the duration of the public health emergency for the COVID-19 pandemic, that the typical times for purposes of level selection for an office/outpatient E/M are the times listed in the CPT code descriptor. In the previous Interim Final Rule published March 31, the time was defined as all of the time associated with an E/M on the day of a visit, not just face-to-face time, as was listed in a CMS public use time file. For NP visits, use 15 minutes for 99202, 30 minutes for 99203, 45 minutes for 99204 and 60 minutes for 99205. For EST patients: 10 minutes for 99212, 15 minutes for 99213, 25 minutes for 99214, and 40 minutes for 99215.
  • Merit-based Incentive Payment System (MIPS) Qualified Clinical Data Registries (QCDRs): CMS is delaying by one year the new requirements that QCDRs collect data on a QCDR measure and that QCDR measures are fully developed and tested prior to self-nomination. These requirements will begin with the 2022 performance period.
  • Clarification of new telehealth waivers: Although the wording is confusing, our consultants confirmed that CMS was reluctant to remove the video requirement for telehealth E/M services provided under the codes 99212-99214. What they did is allow telephone only E/M services, billed using the current telephone coding, but increased the payment to levels close to what is paid for in-office visits for 99212-14. YOU WILL HAVE TO UPDATE YOUR BILLING SOFTWARE to reflect the new charges, otherwise Medicare will pay for the lower charge. PHONE ONLY: USE TELEPHONE CODES (billed at the higher rate), VIDEO/AUDIO: USE REGULAR E/M CODES.

Update to CARES Act Provider Relief Fund 

  • The Attestation Portal has been updated to provide additional information regarding the $50 billion Provider Relief Fund. The time limit to attest has been extended to 45 days from the time of receipt of the funds.
  • The first $30 billion has already been distributed, and the next $20 billion is on its way.
  • The Department of Health and Human Services (HHS) has clarified that the total distribution for a provider should be approximately 2% of 2018 gross revenue, based on the following instruction: To calculate your estimated total allocation, divide your “Gross Receipts or Sales” or “Program Service Revenue” by 2.5 trillion and then multiply by 50 billion. (Gross Receipts or Sales) / 2,500,000,000,000) x 50,000,000,000
  • To determine whether a provider will likely receive additional funding from the $20 billion, a provider should examine their 2018 gross patient revenue, as detailed: If the provider received less than 2% of 2018 gross revenue from the initial $30 billion distribution, then the provider may be eligible to receive additional funding up to the 2% calculation. If the distribution from the initial $30 billion is more than 2% of 2018 gross revenue, then the provider will likely need to contact the CARES Provider Relief Hotline to determine next steps. Note that this calculation should be done for all TINs tied to 2018 net patient revenue amount.
  • Further, HHS has stated (per below) that the “names of payment recipients and the amounts received” will be publicly available for “all providers who attest to receipt of a payment and acceptance of the Terms and Conditions.” HHS further notes that a provider should not attest unless the payment is consistent with the estimated allocation.
  • *To estimate the amount likely to be received via this portal application, subtract the amount of payments already received from your total estimated total allocation above.
  • Please do not attest if the payments you have received already exceed your estimated total allocation. Please contact the CARES Provider Relief Hotline at (866) 569-3522 if you believe that you have received an overpayment.

NIAID Study on Children with COVID-19 (HEROS Study)

  • This study will determine how many children are infected and how many go on to have symptoms.
  • The HEROS study team will enroll 6,000 people from 2,000 families already participating in NIH-funded research in 11 U.S. cities and follow them for six months.
  • Healthy children, as well as children with asthma and allergies, will be included.
  • You can read more here.

SBA Economic Injury Disaster Loans Have Changed?

  • According to an article in The Washington Post, the Small Business Administration (SBA) has reduced the maximum loan amount from $2 million to $150,000 and is not accepting new applications. Here is what it says today on the SBA website: SBA has resumed processing Economic Injury Disaster Loan (EIDL) applications that were submitted before the portal stopped accepting new applications on April 15 and will be processing these applications on a first-come, first-served basis. SBA will begin accepting new EIDL and EIDL Advance applications on a limited basis only to provide relief to U.S. agricultural businesses.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, May 5, 2020

The AAAAI COVID-19 Response Task Force has created a new document with Suggestions or Considerations for Resuming Practices.

Click here for a PDF that has been formatted to allow you to easily print or share the document, or access the full text version here from the AAAAI COVID-19 resources page.

The resuming of a practice depends on a risk assessment of community spread of COVID-19 cases and your state’s current status with respect to being open or closed. It is important to realize that this is a fluid and changing environment, that risk may change with time and decisions may need to change.

Everything in this document presumes that the actual infectious state of your patients is unknown and that asymptomatic or pre-symptomatic patients can spread the virus.

Please continue to send any questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 1, 2020

Here are today's important updates:

Clarification Concerning Coding for Procedures and Telemedicine Visits Performed on the Same Day

  • Questions have come up about how to code for the patient who has skin testing or an immunotherapy injection on the same day as a telemedicine E/M visit. This might arise in multi-location practices where the patient goes into one office for a procedure, but then has an E/M visit via telemedicine from another provider.
  • According to AAAAI coding expert Teresa Thompson: You may use two modifiers on a CPT code. You would place the 25 and then the 95 modifier. It will be carrier dependent on which procedures the payer will recognize for telehealth payment. You would not use any modifier on the allergy shot or test if it were performed in person. Place of service would be 11 for the in-person service and then payer dependent on place of service (02 or 11) for the E/M.

Templates and Talking Points for Local Media Outreach

  • It is critical for the practicing allergist to be seen as the expert when it comes to how COVID-19 may impact patients with allergies, asthma and immunologic disorders.
  • The AAAAI has created a template media alert describing the unique perspective an allergist can offer, a template press release on what patients need to know about asthma and COVID-19, and a set of talking points.
  • Update the templates and send them to media contacts in your local area and use the talking points to prepare for interviews. Please note that while the AAAAI is providing these materials to help you, you will be speaking on your own behalf in any interviews you may give.  
  • These communication and outreach tools have also been posted to the AAAAI Original Resources section of our COVID-19 resources page.

Update on Vaccines

  • New York Times report notes that scientists at the Oxford University Jenner Institute say their experimental vaccine protected rhesus monkeys from illness with exposure to SARS-CoV-2. They are scaling up a 6,000 person clinical trial. China has started a 144 participant clinical trial after their vaccine candidate also protected monkeys.

Legislation on Medical Equipment and Supplies

  • Senate Democrats Baldwin, Murphy and Schumer have introduced legislation that lays out a framework for an effective COVID-19 response by federalizing and adding critical oversight and transparency to the supply chain. Forty-six other Democrats have signed on to the Medical Supply Transparency and Delivery Act, which has also received support from unions and nurses. Representatives Porter, Crow, Slotkin and Ryan have introduced companion legislation in the House. Read more about the bill here. Write your members of Congress to support this if you agree.

New Rules and Waivers from CMS

  • The Centers for Medicare & Medicaid Services (CMS) announced a new round of “sweeping changes” on April 30. Here is how they might affect allergists, although most of the changes were announced at the end of March.
  • Pharmacists can work with a physician or other practitioner to provide assessment and specimen collection services, and the physician or other practitioner can bill Medicare for the services. Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice and state law. With these changes, beneficiaries can get tested at “parking lot” test sites operated by pharmacies and other entities consistent with state requirements. Such point-of-care sites are a key component in expanding COVID-19 testing capacity.
  • CMS will allow certain provider-based hospital outpatient departments that relocate off-campus to obtain a temporary exception from payment linked to the PFS and continue to be paid under the OPPS. Importantly, hospitals may also relocate outpatient departments to more than one off-campus location, or partially relocate off-campus while still furnishing care at the original site.
  • CMS is broadening the list of services conducted by audio-only telephone services to include many behavioral health and patient education services. CMS is also increasing payments for these telephone visits to match payments for similar office and outpatient visits. This would increase payments for these services from a range of about $14-$41 to about $46-$110. The payments are retroactive to March 1, 2020.
  • CMS is revamping its processes to add new telehealth services, and will be using a subregulatory basis, considering requests by practitioners, instead of its rulemaking process, which should speed up the process.
  • CMS is waiving the video requirement for certain telephone evaluation and management services, and adding them to the list of Medicare telehealth services. As a result, Medicare beneficiaries will be able to use an audio-only telephone to get these services.
  • Virtual check-in services, or brief check-ins between a patient and their doctor by audio or video device, could previously only be offered to patients that had an established relationship with their doctor. Now, doctors can provide these services to both new and established patients.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 28, 2020

Here are today's important updates:

Testing

  • Lay and medical press reports are talking about serological testing for SARS-CoV-2. Assays for IgM and IgG antibodies are being developed by several commercial laboratories as well as university labs.
  • IgG assays measure the antibody response to SARS-CoV-2, indicating a prior infection (assuming the test accurately distinguishes IgG against SARS-CoV-2 from IgG directed against other coronaviruses, such as circulating CoV) that MAY indicate immunity. It may also help identify sources for donation of convalescent plasma for treatment of patients with COVID-19. We do not know whether the presence of IgG antibody signifies protection, or how long that protection lasts.
  • Antibody tests should not be used to diagnose current COVID-19 infections, and cannot differentiate between those with a current infection (who could still be shedding virus) and those who have already recovered from an infection and are no longer shedding virus.
  • Serological tests typically undergo an approval process by the Food and Drug Administration (FDA), but during this pandemic, a few tests have been authorized through Emergency Use Authorization (EUA) which means that the FDA has reviewed the test, the manufacturer of the test has validation data, and the FDA has authorized the test to be used. To date, the FDA has authorized four tests under the EUA.
  • To help speed up the process, the FDA has developed a collaboration with the National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention (CDC) to help evaluate tests, including those currently on the market as well as those not yet available.
  • Last month, as part of a broader strategy, the FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: 1) the tests are validated by the developer to determine that they are accurate and reliable, 2) notification of the developer’s validation is provided to FDA, and 3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. The FDA policy does not apply to at-home specimen collection or at-home testing. Once the National Institutes of Health (NIH) has been able to provide further data, these tests may be authorized under the EUA or approved.
  • To facilitate awareness of these serological tests, the FDA has been posting on its website the tests for which it has received a notification under this policy since mid-March. They have also updated their website to better clarify which tests have been authorized by FDA and which have not been authorized. However, some test developers have misused the serology test kit notification list to falsely claim their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19.
  • See here and here for more information.

NSAIDs and COVID-19

  • In case you were still wondering, the World Health Organization carried out a rapid systematic review on March 20 on NSAIDs and respiratory viral infections (not just COVID-19).
  • Bottom line: "At present, there is no evidence of an impact of NSAID use on severe adverse events, acute health care utilization, long-term survival or quality of life in patients with COVID-19."
  • Limitations of the study: There was no direct evidence from patients with COVID-19, SARS or MERS available, and studies were largely underpowered to detect rare adverse events.

Treatment for COVID-19

  • The NIH has established a “living” webpage that offers a nice overview and perspective on treatment for COVID-19. As expected, no treatment has been identified that has proven effectiveness.

Counterfeit Respirators

  • The CDC and National Institute for Occupational Safety and Health (NIOSH) have posted warnings about counterfeit respirators and how to spot them. They will post the names of the counterfeit manufacturers on this website as they become aware of them.
  • NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e., on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one of the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
  • Signs that a respirator may be counterfeit:
    1. No markings at all on the filtering facepiece respirator.
    2. No approval (TC) number on filtering facepiece respirator or headband.
    3. No NIOSH markings.
    4. NIOSH is spelled incorrectly.
    5. Presence of decorative fabric or other decorative add-ons (e.g., sequins).
    6. Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children).
    7. Filtering facepiece respirator has ear loops instead of headbands.

CMS Suspends Advance Payment Program

  • On April 26, the Centers for Medicare & Medicaid Services (CMS) announced it is suspending its Advance Payment Program for Part B suppliers effective immediately. This was the temporary loan program for advance payment of Medicare based on the previous years payments, to be paid back over time.
  • Funding will continue to be available from the Provider Relief Fund.
  • CMS had approved 24,000 applications advancing $40.4 billion to health care providers (does not include hospitals).

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 24, 2020

Here are today's important updates:

CARES Act Provider Relief Fund Update

  • The first tranche of relief checks, $30 billion in total, have been mailed out to practitioners who see Medicare patients, with the last checks going out April 17.
  • An additional $20 billion is being distributed beginning today, Friday, April 24, to those providers with a relatively small share of their revenue coming from Medicare FFS, such as children’s hospitals and those practices who see a lot of Medicaid patients. A portion of providers will automatically be sent an advance payment based off the revenue data they submit in Centers for Medicare & Medicaid Services cost reports. Providers without adequate cost report data will have to submit their revenue information to a portal opening this week for additional general distribution funds, which will go out weekly as information is validated. Even those who receive automatic payments will need to submit revenue information to be verified. If a provider received a first stimulus amount, he/she may still receive this second stimulus, which is proportional to providers’ share of 2018 net patient revenue.
  • $10 billion will be allocated for hospitals in areas that have been particularly impacted by COVID-19.
  • Allocation for treatment of the uninsured: Every healthcare provider who has provided treatment for uninsured COVID-19 patients on or after February 4 can request reimbursement through the program and will be reimbursed at Medicare rates, subject to available funding. Steps will involve: enrolling as a provider participant, checking patient eligibility and benefits, submitting patient information, submitting claims, and receiving payment via direct deposit. Providers can register for the program on April 27, 2020, and begin submitting claims in early May 2020. Visit this website for more information. Balance billing not allowed.

Latest Coronavirus Relief Package

  • The total package is $484 billion, bringing the total amount of relief to $2.8 trillion dollars.
  • $310 billion will replenish the Small Business Administration (SBA) Paycheck Protection Program, with $60 billion earmarked for community banks and smaller lenders, which should help smaller and rural businesses who tend to use these types of financial institutions. An additional $60 billion is directed to the SBA for emergency business grants and loans (e.g., Economic Injury Disaster Loan program).
  • $75 billion goes to hospitals and community health centers.
  • $25 billion will boost COVID-19 testing. These monies will be divided between the federal and state governments with $11 billion going to states and localities to scale up testing capacity, $1 billion to the Centers for Disease Control and Prevention for surveillance, epidemiology, lab capacity expansion, and contact tracing, $1.8 billion to the National Institutes of Health to develop, validate and improve testing, $1 billion for the Biomedical Advanced Research and Development Authority for advanced research, and development of testing or related supplies, $22 million for the Food and Drug Administration to support activities associated with testing, $825 million for community health centers and rural health clinics, and up to $1 billion may be used to cover the costs of testing for the uninsured.
  • Check with your banker about the status of your application. If you haven’t applied yet and are getting mixed messages from your banker, remember that smaller practices may have better luck with community banks or lenders.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 21, 2020

Before we get into the important updates we have for you today, we wanted to alert you that the Department of Health and Human Services has again released an updated set of terms and conditions related to the release of the $30 billion in funding from the Public Health and Social Services Emergency Fund. You can find more details by visiting the AAAAI COVID-19 advocacy page and selecting the Physician Provisions link. Hart Health Strategies, the professional advocacy partner of the AAAAI, has been providing this continually updated information on critical issues related to COVID-19. Clear your browser cache before each visit to access the latest news. And don't forget about the JACI: In Practice Twitter chat tomorrow, April 22, at 8:30 pm EDT about this article on Clinician Wellness During the COVID-19 Pandemic. Use the hashtag #JACIIPCOVID.

AMA Advocacy Efforts

  • In a letter to Congressional leaders, the American Medical Association (AMA) urges additional direct financial support for physician practices, additional funding for the Small Business Association Paycheck Protection Program, implementing a positive Medicare fee update for 2020 and beyond, and postponing recoupment of advances until 365 days after the payment is issued, instead of the current 120 days. Please contact your members of Congress today to tell them we need more help.
  • A letter to the Federal Emergency Management Agency urged the creation of a national system for acquisition of PPE, as well as a system of distribution managed by the federal government.
  • Resources that might help state allergy societies and medical societies on the AMA Advocacy Resource Center include an updated state telemedicine chart and COVID-19 state policy guidance on telemedicine, as well as options to address liability protections, reduce administrative barriers and expand coverage.
  • The AAAAI advocacy team has been working closely with AMA advocacy to support these efforts.

Financial Support

  • There was hope that Congress may have reached some sort of consensus this past weekend on additional funding for practices. Now there appear to be sticking points on funding for testing, and the vote may be delayed until later this week.

MIPS Reporting Relief

  • Practices can submit an Extreme and Uncontrollable Circumstances application until April 30 if you are unable to complete your data submission. Completion of the application will result in a neutral payment adjustment. Failure to file the application could result in a negative payment adjustment for practices that have to report.

Updated Guidance from CDC for Healthcare Settings (Updated April 13, 2020)

  • You can read more details here.
  • Implement source control for everyone entering a healthcare facility (staff, patients, visitors) to help prevent transmission from asymptomatic or pre-symptomatic individuals.
  • Measures should be implemented before patient arrival and upon arrival.
  • Temperature and symptom screening should still be performed, but this is not sufficient to prevent transmission.
  • Healthcare facilities should consider implementing policies requiring everyone to wear a cloth face covering (if tolerated and over age 2) while in the building, regardless of symptoms. Patients and visitors should be instructed to avoid touching the face covering, but if they must, they should perform hand hygiene before and after adjusting the mask. Patients may remove their face covering when in the patient room, but should put them back on (see hand hygiene above) if anyone enters the room.
  • HCP should wear a facemask at all times while in the facility. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. HCP should also self screen for symptoms and fever before every shift.
  • Clerical personnel or personnel not in patient care areas might continue to wear their cloth face covering while in the facility, but to avoid the risk of self-contamination, they should consider continuing to wear their respirator or facemask.
  • HCP who enter the room of a patient with known or suspected COVID-19 should adhere to Standard Precautions and use a respirator (or facemask if a respirator is not available), gown, gloves, and eye protection.
  • Manage visitor access by limiting points of entry, and limiting visitors to only those essential for care of the patient. Screen visitors as you do patients.

CMS Issues Recommendations to Re-Open Healthcare Systems

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 17, 2020

We have a variety of important updates for you today:

Management of Asthma and Allergies During the Pollen Season and COVID-19
Current data (emphasis on current) indicates that it is safe to use nasal and inhaled corticosteroids in the management of asthma and allergic rhinitis during the pandemic. It is probably even more important to use these medications to prevent asthma exacerbations and poorly controlled rhinitis with sneezing and rhinorrhea. It is also okay to use systemic corticosteroids when indicated for asthma exacerbations.

CARES ACT Provider Relief Payment Information

  • The CARES Act Provider Relief Fund Payment Attestation Portal is now open. Providers who have been allocated a payment from the initial $30 billion general distribution must sign an attestation confirming receipt of the funds and agree to the terms and conditions within 30 days of payment. The portal has a variety of steps, including confirmation of eligibility, billing TINs, verifying payment information, attestations (likely related to the terms and conditions), and confirmation.
  • As a reminder, payment by the U.S. Department of Health and Human Services (HHS) of this initial tranche of funds is conditioned on the healthcare provider’s acceptance of the terms and conditions (the link was provided in our April 16 message), which acceptance must occur within 30 days of receipt of payment. Not returning the payment within 30 days of receipt will be viewed as acceptance of the terms and conditions, so the provider must do the following: Contact HHS within 30 days of receipt of payment and then remit the full payment to HHS as instructed. The CARES Act Provider Relief Fund Payment Attestation Portal will guide providers through the attestation process to accept or reject the funds.
  • The American Medical Association has received several questions about how to verify eligibility for payment and who to contact when a physician believes they are eligible but did not receive a payment. HHS partnered with UnitedHealth Group (UHG) to deliver the stimulus payments, and physicians should contact UHG’s Provider Relations at 866-569-3522 about eligibility, whether a payment has been issued, and where it was sent. If a physician or practice did not already set up direct deposit through the Centers for Medicare & Medicaid Services or UHG’s Optum Pay, they will receive a check at a later date. Practices that would like to set up direct deposit now can call the UHG Provider Relations number.
  • The Small Business Administration (SBA) Paycheck Protection Program (PPP) is no longer accepting applications since the appropriated monies have been exhausted. The SBA announced that they had processed 1.637 million applications for $339 billion dollars as of April 14. The administration has not released information on how much money has been disbursed, but according to a Washington Post article, anecdotal reports from banks are that only a small proportion of the funds have been disbursed. If you have placed an application already, there is still a possibility of getting some money.

Physician Wellness and Resilience
The American Academy of Pediatrics (AAP) has a new webinar on physician resilience on the AAP YouTube page.

Convalescent Plasma

Genentech Letter on Home Administration of Xolair
Genentech sent a DHCP (Dear Health Care Provider) letter out this week announcing that after consultation with the FDA, they have proposed some criteria for home administration of Xolair. The Task Force would caution that practitioners carefully evaluate each individual patient if considering home administration. Just having an epinephrine auto-injector at home doesn’t always assure appropriate treatment of anaphylaxis. Once home administration starts, it will become the norm, regardless of the FDA black box warning, and in-office administration will likely become the outlier that will require PA.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, April 16, 2020

Before getting into today's Task Force message, we wanted to point out a new AAAAI podcast episode on Using Telemedicine to Provide Care for Allergic Conditions. It features Jennifer Shih, MD, who discusses the practical elements of performing virtual visits. You can listen here. A link to this new podcast episode has also been added to the AAAAI COVID-19 resources page.

The AAAAI COVID-19 resources page also has a new section on clinician wellness and resilience and JACI: In Practice will be hosting a Twitter chat on April 22 at 8:30 pm EDT on this paper: Clinician Wellness During the COVID-19 Pandemic: Extraordinary Times and Unusual Challenges for the Allergist/Immunologist. Use the hashtag #JACIIPCOVID during the chat. 

Comments From the Field
On the RSL call held on April 13, RSL governors shared their experience on getting loans through the Small Business Administration (SBA). Working with the bank that has had your business over the years is probably best, but some of the banks may be too worried about their liability. If you are having problems getting your bank to allow applications, there may be smaller community banks that are anxious for your business and would be willing to move forward a little more rapidly. Don’t be afraid to reach out.

The Task Force would like to know how all of you are coping, and what changes have you made? Don’t hesitate to email us at practicematters@aaaai.org and let us know what you need or what has worked for you.

Be Wary of Legislative Promises
Unfortunately, legislation often reflects politics and not promise. The regulations to fulfill that legislation are what matters, and those have been changing daily. Take everything with a large grain of salt. The AAAAI is trying to provide help on these issues as they arise.

HHS Relief Fund Certification
As an example of changing regulations, here is the latest version of Relief Fund Payment Terms and Conditions.

Key takeaways for recipient certification:

  • Provide, or provided after January 31, 2020, diagnoses, testing or care for individuals with possible or actual cases of COVID-19. Care does not have to be specific to treating COVID-19. The U.S. Department of Health and Human Services (HHS) broadly views every patient as a possible case of COVID-19. If you ceased operation as a result of the COVID-19 pandemic, you are still eligible to receive funds so long as you provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. If you haven’t received a check, please check this website to find out details on the payment process.
  • Payment will only be used to prevent, prepare for and respond to COVID-19, and payment is only for healthcare related expenses or lost revenue.
  • Payment will not be used to reimburse expenses or losses that have been reimbursed from other sources.
  • Special reporting required for any entity receiving more than $150,000 from any of the COVID-19 support programs.
  • Maintain appropriate records and cost documentation including, as applicable, documentation required by 45 CFR § 75.302 – Financial Management and 45 CFR § 75.361 through 75.365 – Record Retention and Access.
  • There is a Surprise Billing component as well. Accordingly, for all care for a possible or actual case of COVID-19, recipient certifies that it will not seek to collect from the patient out-of-pocket expenses in an amount greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network recipient.
  • None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II ($197,300).
  • For additional information, visit this website or the CARES Provider Relief Line can be contacted at (866) 569-3522.

Priorities for the Next $70 Billion
The current payment came from $30 billion of the $100 billion laid out in the CARES Act for provider relief. The Administration is working rapidly on targeted distributions that will focus on providers in areas particularly impacted by the COVID-19 outbreak, rural providers, providers of services with lower shares of Medicare reimbursement or who predominantly serve the Medicaid population, and providers requesting reimbursement for the treatment of uninsured Americans.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 13, 2020

Where Is This Pandemic Headed?
In a recent conversation with JAMA Editor Howard Bauchner, MD, Nicholas Christakis, MD, PhD, MPH, Director of the Human Nature Lab at Yale, discussed the current pandemic, with comparison to the 1957 flu epidemic. The key takeaway is that there may be a slight reduction in cases and spread this summer, but expect a return in the fall.

News on Vaccines
From the Foundation for Biomedical Research, a COVID-19 vaccine candidate being studied at the University of Pittsburgh is provoking the production of SARS-CoV-2 antibodies in mice and they are hoping to move the vaccine into human research soon. There are more than 50 vaccines in the pipeline now, with several being validated in animal studies. The virus doesn't appear to mutate quickly or evade the immune system, and scientists were already working on vaccines for other coronaviruses such as SARS and MERS that were showing promise in animal research.

Keep Well
Consider distancing yourself from the news. Read "Avoiding information overload during the pandemic", where University of Washington Information School Professor David Levy discusses some best practices for navigating our use of devices and the need to be thoughtful about the habits we have in place for choosing what we consume. Pro tip: Turn off your news app notifications.

Healthcare Worker Return-to-Work Criteria
Test-based strategy
Exclude from work until:

  1. Resolution of fever without the use of fever-reducing medications, and
  2. Improvement in respiratory symptoms (e.g., cough, shortness of breath), and
  3. Negative results of a Food and Drug Administration Emergency Use Authorized molecular assay for COVID-19 from at least two consecutive nasopharyngeal swab specimens collected 24 hours or more apart (total of two negative specimens). See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19).

Non-test-based strategy
Exclude from work until:

  1. At least three days (72 hours) have passed since recovery defined as resolution of fever without the use of fever-reducing medications and improvement in respiratory symptoms (e.g., cough, shortness of breath); and,
  2. At least seven days have passed since symptoms first appeared.

After returning to work
Healthcare personnel should:

  1. Wear a facemask at all times while in the healthcare facility until all symptoms are completely resolved or until 14 days after illness onset, whichever is longer.
  2. Be restricted from contact with severely immunocompromised patients (e.g., transplant, hematology-oncology) until 14 days after illness onset.
  3. Adhere to hand hygiene, respiratory hygiene, and cough etiquette in the Centers for Disease Control and Prevention's interim infection control guidance (e.g., cover nose and mouth when coughing or sneezing, dispose of tissues in waste receptacles).
  4. Self-monitor for symptoms, and seek re-evaluation from occupational health if respiratory symptoms recur or worsen.

Read more details here.

Summary of CMS Rulings/Resources
This link
provides a nice summary for clinicians on the waivers/regulations instituted by the Centers for Medicare & Medicaid Services (CMS) during the public health emergency and also has a nice list of resources.

CARES Act Deposits
CARES Act Provider Relief Fund deposits have started to be deposited into accounts. This amount is about 6.2% of your 2019 Medicare FFS (not including Medicare Advantage payments). The portal to attest to receipt of money and agreement of terms will be open the week of April 13, 2020. Attestation must be made within 30 days of receipt of funds. The deposit will come from the U.S. Department of Health & Human Services.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

 Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 10, 2020

Today we have an asthma and COVID-19 update:

  • The Centers for Disease Control and Prevention (CDC) released a new Morbidity and Mortality Weekly Report (MMWR) on April 8 that suggests a possible increased risk for hospitalization due to COVID-19 in asthma patients.
  • This study evaluated hospitalization for COVID-19 in the month of March in the United States, and includes co-morbid disease data from 180 patients (out of 1,482 total subjects in the study). In patients 18-49 years old who were hospitalized with COVID-19, 27.3% (12 out of 44) had a history of asthma. In those patients 50-64 years old asthma was present in 13.2% (7 of 53) and in those 65 years old or older asthma was found in 12.9% (8 of 62). Given the prevalence of asthma in the United States (around 10%), the percentage of patients in the 18-49 year old group with asthma is higher than would be expected in the general population. This suggests that those with asthma in the 18-49 year old age range may be at increased risk of hospitalization due to COVID-19.
  • The prevalence of asthma in this age group is similar to what has been seen with hospitalizations for seasonal influenza. Most likely, this indicates that uncontrolled asthma may be a risk for hospitalization with COVID-19. However, it is important to note that neither asthma control or severity was recorded in this report. Also, the severity of the COVID-19 infection is also not documented.
  • Wheezing was noted in 6.7% of patients (12 out of 180) and was spread amongst the three age groups. This may suggest that patients were not having traditional asthma exacerbations at the time of their hospitalization for COVID-19. This seems to fit with what has been heard anecdotally from EDs around the country—that they aren’t seeing asthma exacerbations due to SARS-CoV-2 (and matches what is known about SARS).
  • As has been reported in the media, 33.1% of the patients were non-Hispanic black, which is markedly higher than the 18% in the study catchment area. The rates for other ethnicities were: white 45% of COVID-19 hospitalized, 59% in catchment area; Hispanic 8% COVID-19 hospitalized, 14% catchment area.
  • Limitations of this report are preliminary data based on 12% of hospitalized patients in 14 states that comprise the COVID-NET group, much of the data is from early in the pandemic in the United States, and an ongoing issue of ethnicity/socioeconomic status and comorbid conditions (do the underlying diseases reflect the risk, or is the risk due to poor healthcare delivery in a population with these underlying diseases). It is important to stress that the numbers may change. There remain no data on non-hospitalized patients, so we don’t know if asthma is a risk for getting the virus or having more severe disease. As this surveillance system develops, we will continue to report the outcomes. At this point, all we can offer for advice is to state that U.S. data suggests that asthma may be a risk factor for hospitalization with COVID-19 and that you need to emphasize asthma control with your patients.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Wednesday, April 8, 2020

Before getting into the topic of today's Task Force message, we wanted to point out a new episode from the AAAAI's Conversations from the World of Allergy podcast series. It's titled How to Manage a Pollen Tsumani in the Midst of a Global Pandemic and features Anne Ellis, MD, FRCPC, FAAAAI, who discusses the management of spring pollen allergies and how this intersects with the current COVID-19 pandemic. Listen here and be sure to share it with your patients. A link to this new podcast episode has also been added to the AAAAI COVID-19 resources page.

Albuterol Shortage

  • The AAAAI was given a link to a database that was provided to all of the dozens of organizations that have participated in the Choosing Wisely campaign. Based on that database, the shortage is currently spotty and does not affect all albuterol inhalers. Please remember to reinforce control with your asthma patients and do not prescribe more than two albuterol inhalers at one time in most of your asthma patients, in order to prevent hoarding.

Treatment for COVID-19

  • Most allergists are not going to be involved in the inpatient treatment of patients with COVID-19 at this point, but they may have to provide medical advice to patients concerning therapy.
  • There has been a considerable amount of coverage in the lay and medical press about the use of chloroquine and hydroxychloroquine for treatment of COVID-19. There was an editorial published in the Annals of Internal Medicine with considerations as to why this may not be a good approach at the current time.
  • Even though this drug has shown promise in in-vitro studies on growth of SARS-CoV-2, it has been shown to have similar effects on influenza virus, but clinical trials on patients with influenza have not shown any benefit. In-vitro effects don’t always pan out in clinical trials.
  • Current retrospective, uncontrolled trials using hydroxychloroquine in patients with severe COVID-19 infection have been small, uncontrolled, and methodologically flawed.
  • Inappropriate use or hoarding of this drug for prevention or treatment has adverse consequences:
  1. Shortages for proven treatment for patients with autoimmune disease, especially SLE.
  2. Shortages for controlled clinical trials in patients with COVID-19.
  3. Inability to recruit patients for clinical trials because they feel they can get the drug for this purpose anyway.
  4. These drugs have the potential for serious adverse consequences.
  5. Some state medical and pharmacy boards are monitoring activity and will be penalizing physicians who prescribe hydoxychloroquine for themselves, family members, across state lines, or when clearly not indicated.
  • Other therapies being studied or considered. There are currently 366 clinical trials on the government website, most of which are for treatment of COVID-19, that are being done internationally. Candidate treatments being evaluated, in addition to the anti-malarials and azithromycin, include iron chelation, anti-virals, a variety of biologic agents, inhaled and systemic steroids, PDE inhibitors, ARBs, recombinant ACE2, anti-IL6 and other biologic agents directed against the inflammatory response, convalescent sera, hyperimmune globulin. Vaccine trials have started with several additional ones planned.

Medicare Telehealth Video

  • The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network (MLN) has produced a nice YouTube video on the different telehealth/electronic/telephone services that are available for Medicare patients and coding that should be used. Access the video here.
  • Other useful links that have been provided in previous messages include this CMS fact sheet, which has a table summarizing the telehealth visits and requirements, and this CMS list of telehealth services. These have also been covered on the AAAAI COVID-19 advocacy page, as provided by Hart Health Strategies.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 7, 2020

Before getting into the topic of today's Task Force message, we wanted to remind you that Hart Health Strategies continues to update the various documents that are listed at the AAAAI COVID-19 advocacy page. In fact, there is a new document with an implementation timeline for what's in the COVID-19 legislation packages. 

To help you know if you are accessing the most recent documents at our COVID-19 advocacy page, we’ve noted the date of the most recent version next to each link. If you are seeing a different date in the footer of the document, please clear your cache so your device downloads the current version. 

Allergist/immunologists should be aware of several themes circulating widely on social media that directly impact our patients. It is important for allergist/immunologists to be aware of these to help discuss with patients, anticipate their questions/confusion, and recognize that these may impair their medical decision making. Many of these sites and accounts look legitimate, but we also must recognize the ongoing widespread deliberate misinformation campaigns across the internet. While some of these recommendations may seem harmless, some can cause direct harm. More importantly, the sheer volume is distracting and dilutes the important public health messaging that we should all be promoting. Examples include:

False Medical Claims

  • Claims of supplements, vitamins, or foods that ‘boost immunity’ are rampant, including from medical professionals and large healthcare organizations.
  • Specific COVID-19 treatments (all unproven) are being touted or sold, including essential oils, supplements, colloidal silver, Vitamin C, elderberry, homeopathy, and chiropractic adjustments.
  • False claims of COVID-19 vaccines are being offered online.
  • Common themes include extrapolation of laboratory/animal data from small studies, pseudoscientific explanations and anecdotal reports.
  • Allergists can help patients by guiding them towards these simple fact-checking questions for any claim: What are the qualifications of the person making the claim? What does the body of evidence demonstrate for both benefits and risks? Is the person making the claim directly profiting from services or products? How can this apply to my specific situation, including factors pertaining to my medical history and possible interaction with medications or underlying conditions?

Asthma

  • While asthma is a widely heterogeneous condition with various levels of severity, risk, and control, asthma in general is listed as a risk factor for severe COVID-19 outcomes by the CDC and WHO. As allergists, we can help patients understand that data from China and Seattle both indicate that asthma was not a risk factor for patients with severe COVID-19 infections. We can also help patients understand the variation in asthma risk according to their personal history.
  • Early reports of systemic corticosteroids being associated with death from COVID-19 are being extrapolated to include ALL steroids as being dangerous. However, patients with asthma should be counseled that their inhaled corticosteroids are safe and necessary to continue to use in order to prevent exacerbation. They should also be aware that systemic corticosteroids can and should be used to treat an asthma exacerbation, even if it is caused by COVID-19.
  • Online discussion of nebulizers is causing confusion for some, as this is misconstrued to indicate that someone can catch COVID-19 from using a nebulizer. Allergists can help clarify and use clear language to inform patients that if they require treatment with nebulized medications, such as albuterol or atrovent due to asthma, they should start treatment early and repeat until better. COVID-19 does not ‘live’ inside nebulizers. However, if the person with asthma who is receiving nebulized treatment has COVID-19, they could spread to others in close proximity due to the respiratory droplets created through the nebulizer.

Cytokine Storm

  • Information is circulating online that patients with severe COVID-19 infection experience a cytokine storm.
  • This is being extrapolated as some to infer that anyone with underlying ‘inflammation’, including allergic conditions, is at risk to experience this cytokine storm if they become ill with COVID-19.
  • Allergists can reassure patients that there is no evidence to suggest their allergic rhinitis, atopic dermatitis, chronic urticaria, food allergies, history of anaphylaxis, etc., places them at risk for severe outcomes should they become sick with COVID-19.

Conspiracy Theories

  • This is a constant presence on social media and underlies many of the anti-vaccine and pseudoscientific claims online. The COVID-19 pandemic has amplified some of these fringe groups and some common themes have circulated, which may impair people’s judgement and affect their medical decision making.
  • Media hoax: This aligns with political ideologies and is leading many to continue to gather in large groups or disregard risk mitigation.
  • Doctors are lying: A campaign has been circulating where people drive to their local hospital and take pictures of empty parking lots or waiting rooms, then claim that there are no sick patients with COVID-19 and this is being falsely amplified.
  • Vaccine development/COVID-19 treatment: Concepts surrounding the need for clinical trials to demonstrate safety, efficacy, and dosing are challenging concepts for many. Policy makers and medical professionals are making recommendations to skip these necessary steps and start using various treatments, including hydroxychloroquine, on a widescale. Allergists are in a position to explain the necessary steps involved in drug and vaccine discovery to patients in an effort to help them understand timeline, expectations, and why some early claims will not pan out.

Supplies

  • Be careful about ads proliferating on social media and even by direct email, from alleged suppliers of PPE. Some of these are legitimate, some do provide the materials but at exorbitant costs, and some are outright scams that take your money but do not provide the goods.

We urge you to keep visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 6, 2020

Recent news has covered concerns about testing for SARS-CoV-2, the virus that causes COVID-19. Recent reports question the accuracy of negative RT-PCR tests and the coming availability of serologic testing. The scientific representatives on the Task Force have prepared the following information:

Specific SARS-CoV-2 Testing (As of April 3, 2020)

The current standard for making the diagnosis of COVID-19 depends on identifying SARS-CoV-2 in respiratory secretions typically testing a swab sample from the nasal-pharynx or oral cavity. The testing method involves a reverse transcriptase (RT) polymerase chain reaction (PCR) to amplify the viral RNA for qualitative detection. Currently the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to more than 20 companies and commercial laboratories. In most cases the assay takes ~2 hours, but there are at least three more rapid testing systems that are approved as a point of care (POC) assay: Abbott ID Now COVID-19 (13 minutes), Mesa Biotech Accula SARS-CoV-2 test (30 minutes), Cepheid Xpert Xpress SARS-CoV-2 test (45 minutes) and there may be additional testing systems that provide rapid results with instruments that are consistent with POC testing. The FDA website has a list of all testing systems having received an EUA including information for healthcare providers regarding each of these.

According to the CDC, “a positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is presumptively infected with the virus” while “a negative result does not exclude the possibility of COVID-19.” The rate of false negative RT-PCR tests is not currently defined. Some of the factors that could contribute include testing sensitivity, timing and location of the sample, as well as other issues.

There is increasing interest in serologic/antibody testing for SARS-CoV-2 and at the present time there are a number of companies providing either a POC test or a laboratory-based immunoassay test for IgM and IgG to SARS-CoV-2. There is interest in POC testing kits for SARS-CoV-2 and currently these are available from diagnostic companies, including 20/20 Bioresponse, BD Biomedomics, Biomerica, Cellex, Sunscreen Diagnostics, plus the distributor Ideal Rehab Care, Inc. This is an incomplete list as there are likely other companies that either have received or will receive in the near future EUA approval by the FDA. These POC tests use a very small volume of whole blood or serum/plasma as the test sample and typically are done on a small cartridge/cassette with results in ~15 minutes. The validation of these various tests varies and often has been done in Asia where the earliest cases of COVID-19 occurred. The FDA authorization includes the disclaimer that the serologic test alone is not for primary diagnosis of COVID-19. The biggest issue to keep in mind with these POC serologic tests is sensitivity (that is true positives) and specificity (the true negatives) from which one can calculate the false negative and false positive rates.

Some of the challenges with interpreting these tests include:

  • Some conflicting data as to how quickly IgM develops relative to the onset of symptoms
  • What is the time-line for IgG production?
  • Ruling out cross reactivity with other strains of CoV that cause URIs

More data on the performance of serologic testing to SARS-CoV-2 is likely to be forthcoming.

At this point the Task Force is unable to make any recommendations as to the appropriate use for these tests, as more information is needed.

Keep visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 3, 2020

We want to remind you that if you need to refer back to any of the previous Task Force messages, you can do so here.

Here are our updates for you today:

There are some clinical issues we would like to share concerning questions we have received. Answers to questions we have been fielding, that would be helpful for a wider audience to see, have been posted to the AAAAI COVID-19 resources page.

Asthma

  • There is no data to support the belief that asthma is a risk factor for COVID-19. Available data suggest that the rate of asthma in patients with severe COVID-19 is the same or lower than the general population.
  • Systemic steroids are not recommended for the treatment of COVID-19, but are okay for asthma exacerbation.
  • It is important to continue to manage your asthma patients and asthma exacerbations according to the guidelines. Focus on asthma control to keep our patients well and out of the emergency room (ER) and urgent care, where the risk for infection with COVID-19 is much higher. This would be a good time to ensure that all of your asthma patients are up to date on medications and treatment plans.
  • There is no evidence that the biologics we use in asthma have any adverse effect on COVID-19 cases, and it would be important to continue them based on the need for asthma control.
  • Steroid dependent asthmatics: Remember adjustments for adrenal insufficiency and severe infection, may need to consider stress doses of hydrocortisone even for patients on high dose ICS. See this article.

Food Allergies

  • Additional counseling for food allergy patients regarding the inability to choose more familiar foods or query waitpersons/chefs when getting restaurant take-out was posted in a previous message.
  • The white paper on COVID-19 and the allergist just published in JACI: In Practice recommends adjusting counseling about epinephrine use in the case of a reaction, emphasizing that transportation to the ER was for the allergic reaction itself and not for potential adverse reactions to epinephrine. If the patient has a mild allergic reaction, an ER trip may not be needed even if epinephrine was administered, in order to reduce the risk for COVID-19 infection.

Prescriptions

The CARES Act removed the requirement that OTC medications require a prescription to allow patients to use HSA or FSA funds to pay for them.

Small Business Loans, Paycheck Protection Program, Loan Forgiveness and Now Employee Retention Credit

  • If you are confused by all the small business resources out there, you are not alone. Visit this very helpful website for an overview and FAQs.
  • Hart Health Strategies continues to add helpful information on small business resources to the AAAAI COVID-19 advocacy page. Look for FAQs on the Paycheck Protection Program (PPP). Expect further guidance as the program rolls out, thus current information should be reviewed with caution. Small businesses can apply for the PPP loans beginning today, April 3, 2020. The sample application form can be found here. Businesses/practices should contact their lender to determine what additional information they require. According to the U.S. Treasury Department, borrowers may “apply through any existing SBA lender or through any federally insured depository institution, federally insured credit union, and Farm Credit System Institution that is participating. Other regulated lenders will be available to make these loans once they are approved and enrolled in the program. You should consult with your local lender as to whether it is participating. Visit SBA.gov for a list of SBA lenders.
  • Employee Retention Credit (Visit this website)
  1. Eligibility: 50% reduction in revenue compared to similar quarter in 2019.
  2. Talk with the SBA or your banker about using this credit and applying for loan forgiveness. You may not be able to do both.
  3. Credit: 50% of qualifying wages and some benefits paid up to $10,000 between March 12, 2020, and January 1, 2021.
  4. Immediate reimbursement: Employers can be immediately reimbursed for the credit by reducing their required deposits of payroll taxes that have been withheld from employees’ wages by the amount of the credit.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Wednesday, April 1, 2020

Here are our important updates for today:

Attend the Special COVID-19 Edition of Virtual Journal Club Tonight

Join JACI: In Practice and the New Allergist/Immunology Assembly tonight, Wednesday, April 1, at 8:30 pm EDT for a special Virtual Journal Club webinar, which will discuss two recently published COVID-19 papers: Telemedicine in the Era of COVID-19 and COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic. This one-hour webinar is free for members and non-members alike. You can register here.

Small Business Loan Program Expected to Be Up and Running by April 3

  • Businesses can go to participating lenders, banks, and credit unions to apply for a loan and be approved the same day.
  • Participating lenders should be listed on the Small Business Administration (SBA) website.
  • Contact your local banker for more details.
  • As there are different loans, some of them must be filed online.

New CMS Rules and Waivers

On March 30, the Centers for Medicare & Medicaid Services (CMS) issued a “wave” of new rules and regulations, most of which affect hospitals and large healthcare institutions caring for acutely ill COVID-19 patients, and most of which do not affect the typical practicing allergist. Many of these seem to be already in place. Below are some changes that might affect our members. As always, regulations and in-place changes may lag behind announcements.

  • Medicare will pay laboratory technicians to collect specimens at home for COVID-19 testing.
  • Efforts to rapidly expand the healthcare workforce
  • Hospitals can provide meals, laundry services and childcare for their staff.
  • Attendings can supervise residents virtually.
  • Waived requirements for a nurse to conduct an onsite visit every two weeks for home health
  • Removed barriers for hospitals to hire community and out of state practitioners
  • Promote telehealth in Medicare
  1. 80 additional services, including ER visits, can be provided by telehealth.
  2. If a physician determines that a Medicare beneficiary should not leave home because of a medical contraindication or due to suspected or confirmed COVID-19, they will be considered homebound and qualify for the Medicare Home Health Benefit.
  3. Virtual Check-In services can now be provided for both new and established patients.
  4. E/M selection can be based on MDM or time, requirements for history and/or PE in the EHR removed for duration of the PHE.
  5. Hospitals can support physician’s practices by transferring items for telehealth.
  6. States who have not yet applied for Medicare waivers do not need to do so with these blanket waivers (15 states have already been granted these waivers).

Billing for Professional Health Services During the Public Health Emergency

  • This guideline was released by CMS on March 31.
  • Traditional Medicare telehealth services professional claims should reflect the designated POS code 02-Telehealth, to indicate the billed service was furnished as a professional telehealth service from a distant site. There is no change to the facility/non-facility payment differential applied based on POS. Claims submitted with POS code 02 will continue to pay at the facility rate.

Remember to visit the AAAAI COVID-19 resources page, which is being updated often. If you need to refer back to any of the previous Task Force messages, you can do so here.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, March 31, 2020

Here are the updates we have for you today:

Accelerated and Advanced Medicare Payment Program

  1. Have billed Medicare for claims within 180 days prior to the date of the request
  2. Not be in bankruptcy
  3. Not be under active medical review
  4. Not have any outstanding delinquent Medicare overpayments
  • Medicare will start accepting and processing the requests immediately.
  • Providers can request up to 100% of the Medicare payment amount for a three month period (based on prior three month periods of Medicare payments). A specific amount must be listed.
  • Request forms are available on your MAC’s website.
  • Payment will be issued by your MAC within seven days of receiving the request.
  • Repayment begins 120 days after receipt of issuance of payment, and must be complete by 210 days after issuance.
  • Regarding recoupment and reconciliation, the provider/supplier can continue to submit claims as usual after the issuance of the accelerated or advance payment; however, recoupment will not begin for 120 days. Providers/suppliers will receive full payments for their claims during the 120-day delay period. At the end of the 120-day period, the recoupment process will begin and every claim submitted by the provider/supplier will be offset from the new claims to repay the accelerated/advanced payment. Thus, instead of receiving payment for newly submitted claims, the provider’s/supplier’s outstanding accelerated/advance pay will be deducted from the new claims.

Updates to the SBA Emergency Loan and Paycheck Program from Hart Health Strategies

  • Loans have to be processed through Small Business Administration (SBA)-affiliated lenders. Currently the “find a lender” link on the SBA website is non-functional. It is likely to take the SBA a few days to update their information and application processes.
  • Contacting banks may be the best way, but they have to be an SBA lender.
  • The 100 most active lenders for SBA 7(a) loans from 2019 can be found here.
  • Because of the changes to the 7(a) loan process, it still may take a few days for banks to update their application processes.
  • Once the SBA has figured out the application process for the loan, then they have to issue guidance or regulation on the forgiveness within 30 days.
  • The forgiveness is only for an eight week period, beginning on the date of loan origination. You will need to be ready to move forward quickly once the processes are established. In order for the forgiveness to be complete, you may need to rehire any furloughed employees and that has to happen before the end of June.

DEA Changes

  • In response to the COVID-19 outbreak, the Drug Enforcement Administration (DEA) has made some changes in its allowances for prescribing controlled substances. Details may be noted here.

EoE/EGID and COVID-19 World-Wide Data Collection Resource

  • This platform has been developed to collect information on patients previously diagnosed with Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Diseases (EGID) who are under high suspicion or confirmed with a diagnosis of COVID-19.
  • We encourage practitioners world-wide to report ALL confirmed cases (including asymptomatic cases identified by through public health screening) and severe cases for whom COVID-19 has not been confirmed because of the lack of available testing (these will be listed as unconfirmed in the questionnaire).
  • This case report form should be completed after the patient has had COVID-19 for a long enough duration to experience partial or complete recovery, hospitalization, or death.
  • To report a case of COVID-19 in an EoE/EGID patient please follow this link.

IDF Survey Project

  • The Immune Deficiency Foundation (IDF) has launched a COVID-19 & PI survey project to collect data each week on issues affecting the PI community. This survey is for patients, asks basic questions and allows the ability to sign up for the larger, ongoing study. It will only be live until Thursday, April 2. Please tell your PI patients and pass on this link from the IDF website that describes how to access the survey.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the COVID-19 Response Task Force

 


Monday, March 30, 2020

Today's message from the AAAAI COVID-19 Response Task Force will focus on some advocacy updates and highlights from the CARES Act.

Advocacy

CARES Act (Also Known As H.R. 748)

  • There are many tax provisions for individual, joint and corporate filers in this bill to allow for increased deductions and delayed payments. Talk to your accountant!
  1. Certain payroll taxes deferred through 2020, will not become due until the end of 2021 (50%) and 2022 (50%).
  2. Any business that does not have a loan forgiven under the new Small Business Administration (SBA) Paycheck Protection Program (see below) is eligible for the payroll tax deferral.
  • A $100 billion fund, run through the Public Health and Social Services Emergency Fund, will cover non-reimbursable expenses attributed to COVID-19.
  1. Designed to be immediately responsive to needs. The Department of Health and Human Services (HHS) will release funds to healthcare entities on a rolling basis as qualified applications are received. The HHS Secretary still needs to release guidance on the application process.
  2. Non-reimbursable expenses include PPE or foregone revenue from cancelled procedures, such as skin tests, spirometry, etc.
  • Specific details about the 7(a) SBA Paycheck Protection Program can be found here
  1. $500 billion, 100% federally guaranteed loans to employers who maintain their payroll during this emergency, maximum $10 million – loans forgiven if payroll maintained.
  2. Apply to an SBA-approved lender for a loan up to 250% of average monthly payroll costs (from 2/15/19 to 6/30/19) to cover eight weeks of payroll, benefits, and other expenses like rent, mortgage, and utilities.
  3. Loan can be forgiven based on maintaining employee and salary levels.

- Amount forgiven is reduced in proportion to number of employees retained, if any wages are reduced by more than 25%.

- This reduction will not apply if you rehire employees previously laid off or resume prior wages by June 30, 2020.
- For any portion of the loan not forgiven, payback terms include maximum term of 10 years and maximum interest rate of 4%.
- Available through June 30, 2020.

  • There is an employee retention tax credit for businesses that are not eligible or choose not to participate in the SBA Paycheck Protection Program.
  1. Any business forced to fully or partially suspend operations, or that has seen a significant drop in revenues are eligible for 50% credit for wages paid to furloughed or reduced-hour employees.
  2. For businesses with 100 employees or less, credit is based on all wages paid, regardless of whether the employee is furloughed.
  3. Can be claimed against the business quarterly payroll tax liability and is fully refundable to the extent of excess. Check IRS.gov and talk to your payroll service provider.
  • $17 billion for immediate relief to small businesses with non-disaster SBA loans. SBA will cover all loan payments for six months.
  • SBA Economic Injury Emergency Grant Program: Emergency advance of up to $10,000 to small businesses and private non-profits within three days of applying for an SBA Economic Injury Disaster Loan (which was discussed in a previous message). Ask for it when you apply for the loan – does not need to be repaid.
  • Medicare patients can fill up to 90 days of medications if prescribed.
  • Unemployment Insurance
  1. An additional $600 added to every check between now and July 31. Expands insurance to individuals who are not traditionally covered, including self-insured, and independent contractors. Contact your state unemployment office.
  2. Eligible for an additional 13 weeks of benefits if you have already exhausted your benefits.
  3. There are incentives for states to waive the waiting week.
  • Emergency Leave Provisions Changed
  1. With respect to the paid sick and family leave discussed in our last message, as provided by the Family Coronavirus Recovery Act, the CARES Act made some changes, including allowing the Secretary of Labor to exempt employers with fewer than 50 employees from the requirement to provide paid leave for childcare due to closures of schools and daycare. Additionally, employers of healthcare providers have the authority to unilaterally exclude their employees from all of the paid sick leave and family leave requirements.
  • Higher Education
  1. $13.9 billion Higher Education Emergency Relief Fund to support students and colleges/universities. Most will go to public institutions.
  2. Federal student loan borrowers do not need to make payments through September 30, 2020, and interest does not accrue.
  • Child Care
  1. States can use their funding through the Child Care and Development Block Grant to provide child care assistance to healthcare sector employees.

Your feedback makes our resources even better. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, March 27, 2020

Today’s message from the AAAAI COVID-19 Response Task Force will focus on resources for small businesses during this outbreak, as well as highlights from COVID-19 legislation passed by Congress. You can learn more at the AAAAI COVID-19 Advocacy page, under the heading Small Business Resources.

We also want to remind you to join JACI: In Practice and the New Allergist/Immunology Assembly on Wednesday, April 1 at 8:30 pm EDT for a special Virtual Journal Club webinar, which will discuss two recently published COVID-19 papers: Telemedicine in the Era of COVID-19 and COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic. This one-hour webinar is free for members and non-members alike. You can find the link to register on this page.

What We Need to Do as Employers

  • We all know that we want our employees who are sick to stay home. To accomplish this, be flexible about sick leave policies for employees who are sick or who have family members at home. The Centers for Disease Control and Prevention has guidelines for how to deal with sick employees.
  • Familiarize yourself with the “return to work” criteria and make sure the employee knows as well.
  • Make sure that contracted companies like janitorial and temp employees also understand about the importance of sick employees.
  • Cross-train employees to prepare for increased absenteeism.
  • Establish policies and practices for “social distancing” in the workplace.
  • Establish new policies for routine and enhanced cleaning of the workplace.
  • Discourage employees from using other workers' phones or equipment when possible. If not possible, clean and disinfect them before and after use.
  • Check with your insurance broker to see if you have business interruption coverage, and find out what the details of coverage are.
  • Communicate with your patients about changes.

Food Allergy Patients

  • Additional counseling may be needed for your food allergy patients, especially as the United States moves to grocery and restaurant pick-up service, and patients aren’t able to pick and choose their favorites or query wait staff or chefs.

Economic Injury Disaster Loans

  • The Small Business Administration (SBA) has set up a webpage. You can actually apply for loans from this webpage.
  • The SBA will work with state governors to provide small businesses with working capital loans of up to $2 million at low interest rates (3.75%).
  • Long-term repayment plans up to 30 years are available.
  • Loans can be used to pay fixed debts (rent, lease), payroll, accounts payable, and other bills.
  • For additional information, contact the SBA Disaster Assistance Customer Service Center at 1-800-659-2955 or email them at disastercustomerservice@sba.gov.

Family First Coronavirus Response Act

  • This is also known as the Phase II package or H.R. 6201. It applies to employers with fewer than 500 employees and is effective April 3, 2020.
  • Includes two weeks paid sick leave for full-time covered employees for COVID-19-related quarantine, symptoms, an ill family member with COVID-19, or for provision of childcare.
  • Includes 10 weeks of paid family and medical leave for employees (employed at least 30 days) who are unable to work due to childcare needs if schools or childcare facilities are closed.
  • Covers regular rate of pay (cap $511/day) for quarantine or symptoms of employee, or two-thirds regular rate (cap $200/day) for family or childcare.
  • Refundable payroll tax credit will reimburse businesses for sick leave, or family and medical leave wages paid to employees affected by COVID-19.
  • If you can’t afford the employee costs associated with such paid leave, the Treasury Department has stated that it will use its regulatory authority to advance funds to employers concerned about cash flow.
  • Employers must provide employees notice of eligibility for paid sick leave and family and medical leave. The Department of Labor is supposed to provide a model notification.
  • Be aware there are special rules for part-time employees and those who are self-employed.

Academic Institutions

  • The Accreditation Council for Graduate Medical Education has provided guidance to academic teaching centers regarding graduate medical education (GME) requirements. It allows institutions to declare pandemic emergencies and suspend all GME requirements, if needed.
  • The American Board of Allergy and Immunology and training programs are considering ways to compensate for lost teaching time for fellows-in-training.

 

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, March 26, 2020

How do these emergency declarations affect the allergist/immunologist? Here are some highlights. To learn more visit the AAAAI COVID-19 resources page and remember to bookmark the page and check it often.

Federal Guidelines/Legislation
Although details are changing daily, these declarations allow the Department of Health and Human Services to:

  • adjust Medicare reimbursement for certain Part B drugs
  • modify the practice of telemedicine (see below)
  • provide financial and other assistance to state and local governments to respond to the pandemic
  • modify/waive certain conditions on participation in Medicare and Medicaid, sanctions related to the Stark law, and sanctions and penalties related to HIPAA privacy regulations.

The Family First Coronavirus Act included provisions to extend coverage without cost sharing for tests and office visits related to COVID-19, and allowed expansion of Medicaid.

Telemedicine
The COVID-19 Response Task Force strongly encourages the use of the Telemedicine Toolkit on the AAAAI website. Other resources include the American Medical Association, American Academy of Pediatrics, and many state medical societies. Check their websites for more information.

  • Call your malpractice provider and ensure telemedicine coverage.
  • Have patients sign a consent for telemedicine.
  • All the major carriers appear to be, at least temporarily, reimbursing for telemedicine. Most will have the information on their landing page or their COVID 19-page. See below for Medicare. In some states, telephone visits will be reimbursed at the same rate as virtual visits for Medicaid.
  • Billing: Use standard E/M code, location code 02, modifier -GT or -95 (modifier will depend upon carrier).
  • UHC
  • Aetna
  • Medicare: See here or here.
  • “Blues”: Check on the Blues website for your area.

The Federal Response for Telehealth

  • Broadened circumstances where Medicare telemedicine can be provided; visits will be considered the same as in-office visits and reimbursed as such, and new patient visits by telehealth are now allowed.
  • Allowed enforcement discretion for certain widely used communication tools such as FaceTime or Skype.

General Information
We hope to soon solve the PPE shortages with involvement of private industry, now that President Trump has invoked the Defense Production Act. Here is an example.

There are excellent patient resources on the AAAAI COVID-19 resources page that you can post on your own website or use in social media. Topics include:

  • general information about the origin and symptoms of the disease
  • recommendations for your patients, and more.

For state information, consult this document for continuously updated information from Hart Health.

It is important to be alert for potential shortages of albuterol MDIs, since nebulization is now discouraged.

Upcoming Topics for Messages from the AAAAI COVID-19 Response Task Force
Highlights of the Congressional response to COVID-19, small business resources, and regulations concerning employee issues, such as leave time, and unemployment benefits are coming soon.

We know you all have many questions and we will try to answer all of them, although not necessarily individually. Please send them to practicematters@aaaai.org.

 

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Wednesday, March 25, 2020

Message from the Chair of the COVID-19 Response Task Force

Hello, we are the AAAAI COVID-19 Response Task Force. I am serving as Chair and our members are:

  • Andrew W. Murphy, MD, FAAAAI (Chair of the Office of Practice Management)
  • Sharon B. Markovics, MD, FAAAAI (Vice Chair of the Office of Practice Management, Board member)
  • James H. Sussman, DO, FAAAAI (Chair of the RSL Assembly, member of the Office of Practice Management)
  • Priya J. Bansal, MD, FAAAAI (Chair of the Practice Management Committee)
  • Frank S. Virant, MD, FAAAAI (Board member)
  • Mitchell H. Grayson, MD, FAAAAI (Scientific guidance, academic institution representative)
  • David R. Stukus, MD, FAAAAI (Social Media Medical Editor)
  • Thomas A. Fleisher, MD, FAAAAI (Executive Vice President) – Ex Officio
  • Mary Beth Fasano, MD, MSPH, FAAAAI (President) – Ex Officio
  • Rebecca Brandt, CAE – Staff Liaison

Our charge is to:

  • Monitor the impact of COVID-19 on the practicing allergist/immunologist, academic divisions of allergy/immunology and fellows-in-training.
  • Serve as a rapid response team to address and communicate urgent issues related to the practice of allergy/immunology in the context of the pandemic.
  • Develop and disseminate information and resources critical to the practice of A/I in the face of the pandemic and its aftermath.
  • Work with Hart Health Strategies to assure the voice of the A/I community is heard at the state and federal level to address issues related to expanding coverage for telehealth services nationwide, home infusion services, potential risk for shortages of critical medications/supplies, financial impact of the pandemic on practices, etc.

Expect to see messages from us on a regular basis in the next several weeks with information and resources for you. Any questions for the COVID-19 Response Task Force can be sent to practicematters@aaaai.org.


Sincerely,

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Paul V. Williams, MD, FAAAAI

Chair of the COVID-19 Response Task Force