Dangerous Delta variant surges: Your COVID-19 Briefing
This edition of the WellSky COVID-19 Briefing is our final monthly installment. It has been our sincere privilege to provide you with news and valuable guidance throughout the historic events of the past 16 months. Although the public health emergency continues, the darkest days appear to be behind us. Vaccination has dramatically reduced new cases, and they continue to trend downward. The WellSky team and our industry colleagues will monitor future developments and will provide you with important, timely updates as needed on the news and regulatory changes that affect you and your business. We are all in this together. And, as always, WellSky is committed to your success.
In this edition
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Please note
The views, information, and guidance in this resource are provided by the author and do not necessarily reflect those of WellSky. The content provided herein is intended for informational purposes only. The information may be incomplete, and WellSky undertakes no duty to update the information. It is shared with the understanding that WellSky is not rendering medical, legal, financial, accounting, or other professional advice. WellSky disclaims any and all liability to all third parties arising out of or related to this content. WellSky does not make any guarantees or warranties concerning the information contained in this resource. If expert assistance is required, please seek the services of an experienced, competent practitioner in the relevant field. WellSky resources are not substitutes for the official information sources on COVID-19. Providers should continue to track developments on official CMS and CDC pages, including:
CMS response to Coronavirus and latest program guidance
CDC interim infection prevention and control recommendations
Current Cases and Maps
July is here, summer is in full swing, and COVID-19 concerns are heating up again. With the surge of the Delta (fourth) variant, hospitals are, once again, starting to round up ventilators, public health officials are concerned, and there is much talk about the effectiveness of vaccines and whether or not boosters are viable options for strengthening immunity. While there isn’t much green on the New York Times heat map below, we can see some areas that are causes for concern. Thankfully, we have left the pervasive blazing orange and red hues from prior months behind.
In fact, there are several rural areas with pockets of risk related to the spread of the new Delta variant – especially in states like Arkansas, Missouri, Colorado, Utah, and Nevada where 50% of the new cases are related to this new strain of the virus. The map showing overall risk levels by county, highlights the concentration of risk in some of these rural areas – and, that risk may be growing.
The Biden Administration announced last week that it would be sending “surge response” teams to areas where the Delta variant has been detected. According to the Centers for Disease Prevention and Control (CDC) there are about 1,000 counties nationwide, mostly in the Southeast and Southwest, where fewer than 30% of residents have been vaccinated and where there are fears for increased case counts and hospitalizations. Currently, 57% of all adults in the country are fully vaccinated while two-thirds have received at least one of two shots. The country did not meet the 70% vaccination goal by July 4, and signs show that most adults who plan to get vaccinated have already done so. Tests for COVID-19 are steadily declining as more people become vaccinated.
Communities where there are larger segments of the adult population who remain unvaccinated are the areas generating the greatest concern. Unvaccinated individuals who are infected with the Delta variant are twice as likely to be hospitalized as those who were infected with the Alpha variant which was first detected in the UK. Many who have remained concerned about large gatherings over the July 4th holiday expect that we will witness the fallout from the combination of the new variant and increased holiday activity in the next five to seven days. Although the World Health Organization (WHO) has reverted to urging everyone, worldwide, to again don their masks, the CDC is holding with its recent guidance that those who are fully vaccinated can go without.
New cases are averaging almost 13,000 per day across the country, which is an increase of 9%.
Hospitalizations continue to level off, although in Missouri and Arkansas we are seeing a rise in the number of patients being admitted.
The mortality rate continues to drop and is down by at least 20% over the last 14 days.
As more people are vaccinated, a very small number of vaccinated people are still dying from the virus even though recent statistics show that 99.5% of all mortalities have been among unvaccinated individuals. As many epidemiologists have pointed out, no vaccine is 100% effective. Not everyone, especially those with compromised immune systems or other serious illnesses such as diabetes, respiratory disease, or hypertension, is able to mount an effective response to the virus even with the protection of a vaccination. More to the point, the risk of death from COVID-19 goes up with age. This makes the work – and continued caution and exercise of infection control – even more important for home health and hospice whether or not infection rates are being reduced.
News
COVID-19 and children
The most common strain of COVID-19 now circulating in the US is the Delta variant – just when schools are planning to get back into a more normal routine next month and when many have plans to head out for vacations and other outings missed last year during the height of the pandemic. While a large percentage of adults are now fully vaccinated, most children, especially those under the age of 12, are not. This poses some concern given that the very infectious Delta strain now accounts for about 40% of the new cases being recorded in the US.
An article in the Wall Street Journal suggests that scientists do not believe there is any evidence to support the notion that the newest variant is more severe in children, according to Monica Gandhi of the University of California, San Francisco. Nonetheless, here is what experts are recommending to keep kids safe this summer.
- Children who remain unvaccinated should continue to wear masks indoors unless they are at home.
- Be aware of case surges and infection hotspots when planning travel especially in areas of the country where fewer adults have been vaccinated, as there will likely be more strain on hospital capacity in those areas. For some who are going to more rural areas for camping trips, this could end up being important.
- Even though some international travel destinations have opened up, it may be wise to keep unvaccinated children at home given that the vaccination rates in the US are higher than in other countries.
- Take extra precautions for children at higher risk – those who have cardiopulmonary conditions or who are immunocompromised – by being more careful about masking and social distancing. For some, travel and play dates may not be advisable.
- Get kids vaccinated as soon as they are eligible.
- Be consistently aware of local conditions and new case rates, taking precautions whether or not the CDC or state/local governments have mandated protective measures.
Compliance
Provider Relief Fund reporting
The Provider Relief Fund portal is now open. The first time one logs in, it will be necessary to create a new account to access the portal. As we reported last month, the deadline to use funds depends on the date funds were received as shown in the table below. Generally, providers have a quarter within which to report after the deadline to use funds.
Provider Relief Funds Receipt, use, and reporting timelines | |||
Period | Funding receipt date | Deadline to use funds | Reporting window |
1 | 4/10/2020 – 6/30/2020 | 6/30/2021 | 7/1/2021 – 9/30/2021 |
2 | 7/1/2020 – 12/31/2020 | 12/31/2021 | 1/1/22 – 3/31/22 |
3 | 1/1/2021 – 6/30/2021 | 1/30/2022 | 7/1/2022 – 9/30/2022 |
4 | 7/1/2021 – 12/31/2021 | 12/31/2022 | 1/1/2022 – 3/31/2023 |
Readers should remember that agencies that received funds may offset them against eligible expenses associated with the prevention and management of COVID-19 and revenue losses incurred as a result of the public health emergency. The Health Resources and Services Administration (HRSA) has developed an Excel spreadsheet to assist providers in calculating the offsets for Provider Relief Funds by category. The worksheet contains tabs for:
- Other assistance received – including Paycheck Protection Loans, other SBA or Treasury funds, FEMA funding, local/state/tribal assistance, CARES Act testing assistance, proceeds from business insurance and/or other sources.
- Infection control funds – for use only by nursing facilities.
- Unreimbursed expenses – including general and administrative and healthcare-related expenses.
- Patient care revenues – there are three options:
- Option 1 – Based on 2019 actual revenue
- Option 2 – Based on 2020 budgeted revenue
- Option 3 – Using an alternate methodology
- Personnel, patient, and facility statistics and measures.
In addition to opening the portal for reporting, HRSA also updated the Provider Relief Fund FAQs as of July 1. Following are the guidance updates that will be most important for post-acute providers to know:
- Unused or unallocated funds as of the end of the reporting period must be returned to HRSA within 30 days.
- Providers that received funds must only use the funds to pay eligible expenses, including services rendered, and to cover lost revenues attributable to COVID-19 on or before the deadline for use of funds. Providers are required to maintain supporting documentation that demonstrates that expenses were incurred during the period of availability; however, that documentation is not to be submitted when reporting.
- If tangible purchases are made with Provider Relief Funds, the item need not be in the possession of the provider by the period deadline as long as the expense was incurred on or before that date.
- Providers that purchased Medicare-certified agencies in 2019, 2020, and/or 2021 cannot accept Provider Relief Funds from a prior owner and complete the attestation for the Terms and Conditions related to PRF on behalf of the prior owner.
- Even though staff members may have been working remotely during the reporting period, the agency cannot offset rent or mortgage payments against Provider Relief Funds just because office space remained unoccupied due to the public health emergency. The funds were provided to offset “costs incurred to prevent, prepare for and respond to” COVID-19.
- Provider Relief Fund payments may be applied to expenses or lost revenues attributable to coronavirus, after netting the other funds received or obligated to be received and which offset those expenses. If a provider has submitted an application to FEMA, but has not yet received the FEMA funds, the provider should not report the requested FEMA amounts in the Provider Relief Fund report. If FEMA funds are received during the same Payment Received Period in which the provider is reporting on use of Provider Relief Fund payments, the receipt and application of each payment type is required in the Provider Relief Fund reporting process. If an entity receives a retroactive payment from FEMA that overlaps with the period of availability, the entity must not use the FEMA payment on expenses or lost revenues already reimbursed by Provider Relief Fund payments.
- There is no minimum or maximum allotment of Provider Relief Funds that can be allocated to lost revenues over the reporting period. This means that, in theory, an agency could have no expenses that are allocable to Provider Relief Funds as the entirety of the funding is consumed by lost revenues over the measurement period.
- Budgets for 2020 can be used to establish lost revenues from COVID-19 if the budgets were established prior to March 27, 2020. The budget must have been ratified, certified, or adopted by the agency’s board, financial executive, executive officer, or other responsible party by that date.
- Even though providers are expected to report other assistance that was received, the level of such assistance will not be taken into account for purposes of satisfying the use of Provider Relief Funds.
- If an agency has more lost revenue than funding for a certain period for which it received Provider Relief Funds, the excess lost revenue can be carried forward and applied against later periods.
- All Reporting Entities that opt to report lost revenues using Option 1 (Comparison of Actual Revenue) or Option 2 (Comparison of Budgeted Revenue to Actual Revenue), must enter their patient care revenue for each quarter within the entire period of fund availability. Reporting Entities using Option 3 must enter their lost revenues, calculated by any reasonable method, for each quarter during the period of availability.
- For Option 1 and Option 2 revenue loss calculations, lost revenues are calculated for each quarter during the period of availability, as a standalone calculation, with 2019 quarters serving as a baseline. For each calendar year of reporting, the applicable quarters where lost revenues are demonstrated are totaled to determine an annual lost revenues amount. The annual lost revenues are then added together.
- Lost revenues are calculated for each quarter during the period of availability, as a standalone calculation. Provider Relief Fund payments may be used to cover those quarters where patient care revenue losses occurred as long as those losses were attributable to Coronavirus.
- Reporting extensions for providers that received more than $10,000 in the aggregate are not allowed. Providers that are required to report, but fail to submit a completed report by the applicable deadline will be deemed to be out of compliance with the Terms and Conditions of the Provider Relief Fund program and may be subject to recoupment actions.
- Agencies that use the Option 3 revenue estimation approach will be notified if the proposed methodology is not determined to be reasonable. For agencies that are notified, a request will be given to recalculate and resubmit the report within 30 days. In other words, no news will be good news.
Emergency preparedness update
CMS released new emergency preparedness guidance for surveyors and providers on June 21. In essence, the guidance stipulates that providers – including home health and hospice – are required to conduct annual exercises to test the preparedness plan. Providers that have activated their plans are exempt from the next full-scale community or facility-based functional exercise for one year.
In 2019 the testing rules were changed to call for annual testing of the Emergency Preparedness plan largely to ensure that plans are workable and that staff members are appropriately trained to execute them. The latest CMS guidance is designed to inform surveyors and providers, alike, with information that will enable an assessment of compliance with the emergency preparedness requirements as the public health emergency continues. Additional guidance is also being provided for inpatient providers which includes inpatient hospice units. The guidance applies to the next full-scale exercise based on the organization’s 12-month cycle as determined by the facility.
There are five categories of testing exercises.
- Full scale exercises are operations-based exercises that involve multiple agencies or jurisdictions and integration of multiple operational elements that would be called upon in a disaster.
- Functional exercises generally focus on plans, policies, procedures, and staff relative to the management, direction, command, and control functions.
- Mock disaster drills are exercises of choice coordinated for a single agency or provider organization.
- Tabletop exercises are also considered exercises of choice and involve limited activities aimed at discussing and analyzing simulated disaster scenarios.
- Workshops are planning meetings or the like that establish a strategy and structure for an exercise program.
Testing requirements are offered – and slightly different – for inpatient and outpatient providers.
Inpatient service provider testing exercises are expanded to include workshops as an exercise of choice; however, inpatient providers are still required to conduct two emergency preparedness testing exercises annually. As noted, this requirement extends to inpatient hospice providers. Inpatient providers can conduct a full-scale exercise along with an exercise from any one of the other categories. During an emergency, providers are exempt from conducting the next required full-scale exercise or individual facility-based exercise; however, providers must be able to demonstrate that their emergency preparedness plans have, in fact, been activated.
If an inpatient provider is operating under an activated plan, that plan will be recognized by surveyors as satisfying the full-scale exercise for 2021 even if an exemption was also claimed in 2020. For those inpatient providers that have returned to normal, non-emergency status, the expectation is that the full-scale exercise will be performed in 2021.
Outpatient service providers must continue to test annually by participating in a community full-scale exercise or conduct an individual facility-based functional exercise every other year. In the intervening years between full-scale exercises, providers are required to conduct a testing exercise of their choice. Thus, the testing requirement for outpatient providers remains as an annual obligation.
Clinical
Telehealth
Modern Healthcare has published an interesting editorial this week on persistent myths that could send telehealth back to pre-pandemic regulation. Krista Drobac, Executive Director of the Alliance for Connected Care, is the author of the article that suggests that Congress can, and may, roll back elasticities related to the use of telehealth during the public health emergency based on pervasive misconceptions about how the technology is used and how effective it is. She cites five myths that may contribute to a loss of the progress that has been made during the pandemic:
- Lifting telehealth restrictions will result in higher Medicare costs.In fact, according to Drobac, “consistently across provider type, telehealth proved to be a substitution for in-person care” meaning that overall utilization of billable telehealth visits simply replaced in person visits for a time until patients began to revert to in-person visits with providers.
- Patients are not seeing their own physicians.The myth is one of providers who provide only virtual services to patients without an ongoing relationship with them. The opposite is true in that 83% of elderly patients saw their own providers or someone from the same practice during telehealth visits. Only 1% saw a provider that they did not know.
- Telehealth services are susceptible to fraud.This, of course, is an argument that extends to post-acute providers that cannot bill for services; however, the author notes that there have been no studies of Medicare telehealth claims during the pandemic to suggest that telehealth services are being inappropriately used.
- In-person relationship requirements are necessary to prevent higher costs and fraud.Drobac notes that “requiring patients to first complete an in-person visit constrains the ability of providers [to] virtually treat individuals who are homebound, have transportation challenges, or live in underserved areas.” And in fact, the in-person relationship requirements that were first instituted in 2020 were rolled back later. All 50 state legislatures have also moved away from the in-person rule.
- The Biden Administration has the authority to make telehealth changes permanent. This, in fact, is the crux of the issue for home health and hospice providers in that the only way to make the changes brought on by the public health emergency is for Congress to enact enabling legislation.
Finally, the most important aspect of the argument – data can and will dispel the myths around telehealth and how effectively it can be used and evidence of that needs to be brought to Capitol Hill.
Johnson & Johnson vaccine and the Delta variant
Recently, some have suggested that the Johnson & Johnson single dose vaccination may not pack enough of a punch against new strains of COVID-19. This was due, at least in part, to early studies that showed the Johnson & Johnson vaccine to be a little less effective against the virus than the double-dose vaccines offered by Pfizer BioNTech and Moderna. Kaiser Health News is now reporting on information released by the company suggesting that its single dose vaccine is highly effective against the Delta variant and may be long-lasting such that a booster is not needed. Dr. David Diemert, professor of medicine at George Washington University noted that “those who got J&J should be less worried than they may have been before about Delta. [The data] is reassuring.”
Administrative
OSHA directive
Following publication of OSHA’s Emergency Temporary Standard on June 21, the agency issued another directive that sets forth the field inspection and enforcement procedures for the agency. The document addresses procedures related to:
- Evaluation of the written COVID-19 plan
- Patient and non-employee screening and management
- Personal protective equipment
- Aerosol generating procedures
- Physical distancing
- Physical barriers
- Cleaning and disinfecting
- Ventilation
- Employee health screening and medical management
- Vaccination
- Training
- Anti-retaliation
- Requirements at no cost
- Recordkeeping
- Reporting to OSHA
Agencies should keep in mind that the Emergency Temporary Standard is now in effect. COVID-19 Plans must be written plans and will be examined and evaluated during OSHA inspections. Of importance, in addition to document review, is the fact that the OSHA inspectors are charged with ensuring that the required hazard assessment has been performed, that employee records related to potential or actual exposure are being appropriately maintained, and that personal protective equipment is being properly utilized. In the absence of appropriate documentation and operational practices supporting the ETS, inspectors are instructed to issue citations. Read my in-depth summary of the OSHA Emergency Temporary Standard, written with healthcare attorney Robert Markette Jr., CHC, HCS-C, Attorney, Hall, Render, Killian, Heath & Lyman, PC here.
In closing
I keep thinking, after 15 months of writing about COVID-19 and all of the things that agencies and leadership teams need to know about the public health emergency, that one day the pandemic news will dwindle down to nothing. It hasn’t happened yet, and each month I am continually surprised at the breadth and depth of current and noteworthy information. But, little by little, it seems that the good news is outweighing the bad and I’m encouraged about that. While this is our final monthly edition of the WellSky COVID-19 Briefing, we will be back with important COVID-19 updates as they occur. With hopes that your summer season is progressing well, I end with my usual – and now well worn – wish. Be well and stay safe and, most importantly, know that you are appreciated for everything that you do.