New policies and guidance arrive with predicted fall surge: Your WellSky COVID-19 Briefing
In this edition
Use the links listed below to jump between sections.
NEWS
Home Health Emergency Access to Telehealth (HEAT) Act
CMS Open Door Forum
Health and Human Services regulatory reform proposal
CDC expands the definition of “close contact”
Greater use of masks could save lives
COMPLIANCE
SBA updates Paycheck Protection Program FAQs
Revision of Provider Relief Fund reporting requirements
Updates to the Accelerated and Advance Payment Program
CLINICAL
Face masks in short supply
Parosmia could be the latest COVID-19 after-effect
Household spread of COVID-19 is substantial
Infection control training through Project Firstline
ADMINISTRATIVE
Billing and distribution details for COVID-19 vaccine
Update to CMS guidance for use of contracted staff under “Extraordinary Circumstances”
New PEPPER target area for Part D claims
New form and revised worksheets for home health cost reporting
CMS toolkit for community-based services
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:
Current cases & maps
Another month has gone by since our last briefing, and when it comes to the spread of COVID-19, it is clear that things are getting worse, not better. We spent most of the summer months worried about cases in the South and West. For the last several weeks, the focus has been on the Midwest and upper Midwest where the per capita case rates are growing significantly. The map published by the Centers for Disease Control and Prevention (CDC) below shows the states with the highest rate of per capita spread in the seven days ending Sunday, November 8 – the darker the shading, the more pronounced the rate of new case growth. Some mitigation measures have been reintroduced in states where case growth is highest. So far, I am unaware of any plans for reimposed statewide lockdowns even though in areas like mine (Chicago), activities such as indoor dining at restaurants are again off-limits. Many are concerned that if the U.S. follows Europe’s lead with new lockdowns, the economy would be irreparably harmed. I am no economist, so I’ll keep my mask on and leave that discussion to people who know what they are talking about.
Using the New York Times graph that depicts the number of new reported cases by day in the U.S., we can see that the upward trajectory of the case count has been quite steep in the last month. It’s hard to escape a realization that we have arrived at the predicted fall surge with forecasts for a difficult few months between now and spring. The question that runs through my mind – and the minds of many readers, I suspect — is whether we will see a repeat of the patient and family behaviors that became the norm in the early months of 2020: refusing needed services due to fears of exposure. The proclivity of hospitals to continue or discontinue performing elective surgeries could also affect post-acute referral activity, since many of these surgeries produce recommendations for follow-up care at home. Both hospitals and post-acute providers need this revenue stream to prosper.
Even though we know that the COVID-19 mortality rate has always lagged the case growth, the graph of nationwide deaths has not shown the same pronounced uptick as the case count. We are getting better at treating the virus when patients with severe manifestations of the disease are hospitalized.
The look of the New York Times heat map has also changed in the last month, with the illustration of hot spot counties now prevalent throughout a swath of the Midwest’s rural and urban areas. The eastern part of the U.S. is also heavily shaded, indicating that while the virus may not be getting worse there at the same rate as in the upper Midwest, it remains a present and persistent problem.
All of this presents a clear set of questions for the new Administration as it begins its transition planning. President-elect Joe Biden announced the members of his own Coronavirus Task Force this week as a means of spearheading a more focused and robust national mitigation effort. However, that effort is unlikely to produce much in the way of national policy until after January 20, 2021.
Data shows that nursing facilities continue to account for a significant share of COVID-19 deaths in many states. The map below (in shades of orange/red) shows the 17 states where at least 50% of all mortalities are among those in congregate living. In a comparative map from the Kaiser Health Foundation (in shades of blue), we can see that the trend related to nursing home mortalities appears to generally follow the concentration of facilities in each state, with some exceptions in the far west.
To wrap up the statistics, here is where we are now.
- The United States has passed 10 million cases of COVID-19. This represents about 2.5 million new cases in the last month, which is about 83,000 cases a day, on average. On November 5, 20 states set new case records. On November 7, the U.S. saw the largest number of new cases so far — over 127,000.
- Since the October 7 briefing, there have been 31,000 additional deaths from COVID-19 in the U.S. — about a thousand people lost each day for a total of 238,000.
- Based on the CDC’s ensemble forecast (a combination of 33 different forecasts of total mortalities), the prediction is for an increasing number of COVID-19 deaths over the course of the next four weeks with between 4,600 and 11,000 new deaths likely during the week ending November 28. The national ensemble predicts as many as 266,000 total deaths by the end of November.
- A total of 14 states reported record hospitalization rates as of November 4 with 52,000 people being hospitalized for COVID-19, representing a 64% increase since October.
News
Home Health Emergency Access to Telehealth (HEAT) Act
On October 23 a long-awaited bipartisan bill was introduced in Congress by a group of Senators and Representatives including Senators Susan Collins of Maine and Ben Cardin of Maryland, and Representatives Roger Marshall, Terri Sewell, Jodey Arrington, and Mike Thompson.
The proposal would allow home health agencies to bill for telehealth services during a public health emergency, but with some limits.
- Services would require the consent of the beneficiary (or, presumably, their representative as appropriate).
- To ensure that the home health benefit doesn’t morph into a ‘telehealth-only’ benefit, reimbursement would only be provided if the telehealth services constitute no more than half of the billable visits/encounters made during a 30-day payment period.
The National Association for Home Care & Hospice (NAHC) would like for agencies to register their support of the bill with their Congressional members. Readers can access the NAHC Legislative Action Center here and send an e-mail supporting the bill from there.
CMS Open Door Forum
On November 4, the Centers for Medicare & Medicaid Services (CMS) held an Open Door Forum for home health, hospice, and durable medical equipment providers. In addition to providing an update on the 2021 Home Health Final Rule, the following are highlights for home health and hospice providers:
- CMS has launched Care Compare which is an amalgamation of several former healthcare compare sites. Care Compare is now a single site that can be used by patients and families to make decisions concerning their healthcare and provider selection. The home health data includes the new skin integrity measure.
- Care Compare data will not be refreshed in 2021 as a result of reporting exceptions that were implemented in 2020 due to the public health emergency. Agencies that were notified of noncompliance with Home Health Quality Reporting Program (HHQRP) requirements related to 2019 submissions will see reimbursement reductions next year.
- CMS will conduct Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) Survey training on January 29, 2021 from 11:00 a.m. CST – 1:00 p.m. CST/12:00 p.m. EST – 2:00 p.m. EST. The training will be self-directed, and training materials will be available in mid-January. For home health agencies that have no patients for purposes of HHCAHPS, CMS issued a reminder that vendors must still be notified so that vendors can, in turn, indicate the absence of eligible patients to CMS. Without this step, CMS will assume that the agency was noncompliant, and the 2% reimbursement penalty would be levied by the Medicare Administrative Contractors (MACs).
- Hospice providers should be aware that 2021 data collection requirements will impact 2023 reimbursement. The November data refresh will cover the first through fourth quarters of 2019 which will be the last update until 2022, again due to the public health emergency and data reporting exceptions that were implemented earlier this year.
- Hospices that qualify for CAHPS survey exemptions related to 2019 should complete and submit the Participation Exemption for Size Request by December 31, 2020. The form can be found here.
Health and Human Services regulatory reform proposal
On November 4, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking that would require a reassessment of all its regulations at least every decade to determine whether they are subject to review under the Regulatory Flexibility Act. There are certain exceptions (which are explained in the proposed rule), but — in general — any regulation issued by HHS would expire ten years after its effective date unless HHS reassesses it and makes a favorable determination. The assessment would measure the continuing need for the rule, whether there have been public complaints about it, the complexity of the rule, and the extent to which the rule duplicates or conflicts with other rules.
Regulations that have been issued in conjunction with other government agencies and those that cannot be legally rescinded (based on applicable statutes) would not be subject to the review. An HHS data analysis of its regulations found that 85% of those rules created prior to 1990 have not been edited. There are nearly “300 broken citation references in the Code of Federal Regulations” which means that there are sections of the regulations that reference other sections that no longer exist. Anyone who has read regulations lately can certainly resonate with the breaks between the regulations themselves and the underlying sub–regulatory guidance.
The HHS notice also notes that the department has suspended numerous regulations during the pandemic based on the judgment that they impose unnecessary cost. Under the proposed rule, these regulations would have to be regularly reviewed to determine whether they make sense in ordinary times, as well. The full notice can be read here.
CDC expands the definition of “close contact”
In its latest pronouncement, the CDC has redefined what is meant by “close contact.” Previously, close contact was described as an instance where a person spent at least 15 minutes within six feet of an infectious person. The new definition is a total of 15 minutes within six feet of someone who was infectious even if the time isn’t consecutive. Here is the definition and guidance as offered by the CDC:
“Close contact: ‘Someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period* starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated.’
* Individual exposures added together over a 24-hour period (e.g., three 5-minute exposures for a total of 15 minutes). Data are limited, making it difficult to precisely define “close contact;” however, 15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation. Factors to consider when defining close contact include proximity (closer distance likely increases exposure risk), the duration of exposure (longer exposure time likely increases exposure risk), whether the infected individual has symptoms (the period around onset of symptoms is associated with the highest levels of viral shedding), if the infected person was likely to generate respiratory aerosols (e.g., was coughing, singing, shouting), and other environmental factors (crowding, adequacy of ventilation, whether exposure was indoors or outdoors). Because the general public has not received training on proper selection and use of respiratory PPE, such as an N95, the determination of close contact should generally be made irrespective of whether the contact was wearing respiratory PPE. At this time, differential determination of close contact for those using fabric face coverings is not recommended.”
Greater use of masks could save lives
In a new STAT article we learned about a study that supports what scientists have been saying for a long time now — abandoning social distancing could cost many lives, and widespread mask wearing could save tens of thousands. After weeks of campaign stops and a weekend of celebratory demonstrations in the streets of many cities, that is something to think about.
According to Christopher Murray, director of the University of Washington Institute for Health Metrics and Evaluation and a lead author of the study, “We think the key point here is that there’s a huge winter surge coming,” but “expanding mask use is one of the easy wins for the United States.”
The study projects that we could see a half million COVID-19–related mortalities in the United States by the end of February — more than double what we have now. But, 130,000 of those deaths “might be forestalled with universal mask use,” which is defined as a threshold of 95% mask use in public. The authors also estimate that face coverings can reduce the risk of infection by 40%.
Ruth Etzioni of the Fred Hutchinson Cancer Research Center at the University of Washington was not involved in the study but raises the notion that “what should drive policy…is the difference between scenarios with and without masks.” She also said, “We don’t need a model to tell us that we should all be wearing masks, we don’t need a model to tell us that if we continue the way we’re going, we’re going to see tens of thousands more deaths within the next couple of months…but sometimes when a person provides a model and you see…numbers, it helps [to] appropriately freak you out.” Enough said. As much as I hate wearing a mask, it will be a part of the future for a while yet.
Compliance highlights
SBA updates Paycheck Protection Program FAQs
The Small Business Administration (SBA) posted updated FAQs for the Paycheck Protection Program (PPP) on October 7. The latest question and answer relate to the deferral period for borrower payments. Here is what you need to know:
“Question 52: The Paycheck Protection Program Flexibility Act of 2020 (Flexibility Act) extended the deferral period for borrower payments of principal, interest, and fees on all PPP loans to the date that the SBA remits the borrower’s loan forgiveness amount to the lender (or, if the borrower does not apply for loan forgiveness, 10 months after the end of the borrower’s loan forgiveness covered period). Previously, the deferral period could end after 6 months. Are lenders and borrowers required to modify promissory notes used for PPP loans to reflect the extended deferral period?
Answer: The extension of the deferral period under the Flexibility Act automatically applies to all PPP loans. Lenders are required to give immediate effect to the statutory extension and should notify borrowers of the change to the deferral period. SBA does not require a formal modification to the promissory note. A modification of a promissory note to reflect the required statutory deferral period under the Flexibility Act will have no effect on the SBA’s guarantee of the PPP loan.”
Revision of Provider Relief Fund reporting requirements
There is yet another notice from HHS regarding Provider Relief Fund recipients who received payments of at least $10,000. The October 22 notice revises the September 19 notice of reporting requirements. Providers that received funding should be aware of the following:
- Provider Relief Funds are first applied to healthcare–related expenses attributable to COVID-19 that another source has not reimbursed and is not obligated to reimburse, followed by lost patient care revenue, net of the healthcare related expenses that have been applied to funding. Thus, we have a two-step process for allocation of the funds.
- If provider recipients have not expended funds prior to the close of 2020, they will have an additional six months to use the funds for healthcare–related expenses or lost-revenue offsets as long as the offset does not exceed the difference between 2019 and 2021 actual revenue. That means the reporting period from January 2021 through June 2021 will be compared to the same six-month period in 2019.
Updates to the Accelerated and Advance Payment Program
Just after our last briefing, HHS released an updated Fact Sheet on the Accelerated and Advance Payment Program. To reiterate, the repayment process is as follows:
- Repayment does not begin until a year following the receipt of the advance.
- For 11 months thereafter, 25% of claim payments will be recouped.
- Then, beginning with month twelve, payments will be recouped at the rate of 50% of claim payments for another six months.
- If there is any remaining balance owed at the end of the six-month period, the provider will receive a demand letter for the payment.
- Providers will have 30 days to respond to the demand letter and pay the balance in full. If payment is not received within the 30-day period, interest will accrue at the rate of 4% from the letter date and will be assessed for every 30-day period during which a balance is outstanding.
- Providers with hardships may request an extended repayment schedule, and instructions for doing so will be included in the demand letters. The extended repayment period can be for up to three years and, for extreme hardship, can be extended to five years. The extension can only be requested after the demand letter has been received.
- CMS may immediately issue demand letters to providers that it believes received funds in error.
- CMS has established COVID-19 hotlines at each MAC. The hotlines are operational during weekdays.
Clinical highlights
Face masks in short supply
According to the Wall Street Journal, face masks are again in short supply. Stockpiling is in part responsible for the shortage — some of it necessitated by new state requirements — combined with the case surge. The demand for N95s is higher than production rates which has prompted some providers to start reusing masks again. President-elect Biden has suggested that the Defense Production Act should be reinvigorated to address the gap, but he won’t be in a position to do that until January. In the meantime, there are encouraging signs. The 3M Company, which is the largest domestic manufacturer of masks, is on track to produce almost 100 million N95s a month. Honeywell is producing 20 million a month, and other U.S. companies are expected to meet that milestone as well. But it still isn’t enough to meet the demand.
What we know from experience is that lower volume post-acute providers typically end up at the rear of the line when it comes to orders for personal protective equipment (PPE). So, now is a good time to take another look at inventory levels and do what you can to get enough supply on hand.
Parosmia could be the latest COVID-19 after-effect
We learn new things everyday about COVID-19, and the latest comes from a Washington Post article entitled When Coffee Smells Like Gasoline: Covid isn’t just stealing senses, it may be warping them. The article recounts the experience of an infectious-disease physician who was exposed to the virus through a patient. She was eating and drinking “completely normally” again when suddenly food started tasting and smelling strange. Known as parosmia, odor distortion makes things smell different and usually in a very unpleasant way. According to Richard Doty, director of the University of Pennsylvania’s Smell and Taste Center, “It’s more debilitating in some ways than loss of smell,” and certain distortions can cause food to become revolting because flavor is tied to the sense of smell. “Even water can become unpleasant.”
From a questionnaire published by Chemical Sciences in June, it appears that about 7% of roughly 4,000 COVID-19 patients reported experiencing smell distortion, suggesting that this is not an entirely rare occurrence. The distortions are most often observed in those who are recovering from COVID-19 and just getting their sense of smell back. Some who have been triggered by off–putting food smells have resorted to putting wet cotton balls in their noses prior to eating while others have taped their nostrils shut such that the flavor experience is eliminated altogether. The good news is that this seems to be a temporary effect that ultimately resolves.
Household spread of COVID-19 is substantial
On November 6, the CDC released a new Morbidity and Mortality Weekly Report suggesting a 53% household transmission rate for COVID-19. In an analysis of 101 households with a total of 191 household members living with the initially infected patient, “substantial transmission occurred whether the index patient was an adult or a child.” The secondary infection rate of 53% translated to three-quarters of the cases identified within five days. The study included households in Tennessee and Wisconsin from April through September. Fewer than half of the household members with COVID-19 had symptoms at the time of their initial diagnosis and many reported no symptoms even after seven days, “underscoring the potential for transmission from asymptomatic contacts and the importance of quarantine.”
The CDC’s conclusion is that people who suspect that they have been exposed or have a potential case of COVID-19 should self-isolate even before seeking a test.
Infection control training through Project Firstline
The CDC is initiating a national training collaborative for healthcare infection prevention and control called Project Firstline. The collaborative will provide infection control training in the form of accessible videos, each of which will last for about 10 minutes. The first set of videos on basic infection control techniques will be released in mid-November. The project fact sheet can be found here.
The initiative will focus on core training through short videos, practical tools that can be used by providers, partner engagement to share information across healthcare settings, mentorship to connect infection control experts with local healthcare providers, public health technical capacity building, and innovation to deepen knowledge and better inform infection control recommendations in the future.
The American Nurses Association, the American Medical Association, state health departments, and many others are partners in the educational effort.
Administrative highlights
Billing and distribution details for COVID-19 vaccine
On October 28, new CMS guidance was released on vaccine distribution, billing, and payment for providers. The document and interim final rule can be found here. Any vaccine that receives Food and Drug Administration (FDA) approval will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. Once vaccines are approved, CMS will identify the specific vaccine codes, by dose and specific vaccine administration dosage. The payment rate will be $28.39 to administer single-dose vaccines. For those with two or more doses, the initial dose will be $16.94 with the final dose being reimbursed at $28.39.
Update to CMS guidance for use of contracted staff under “Extraordinary Circumstances”
On October 5, CMS issued QSO-21-01-Hospice – Nursing Shortage as an Extraordinary Circumstance per 42 CFR 418.64 . The memorandum, directed to State Survey Agencies, supersedes the previous guidance issued in 2018. The new guidance differs in that there is no expiration date (prior guidance expired on September 20, 2020), and it does not limit authority to contract for core services.
The guidance is applicable to unusual or extraordinary hospice circumstances only and is summarized by CMS as follows:
- Extraordinary Circumstances Related to Hospice Staffing Requirements: A hospice may use contracted staff, if necessary, to supplement hospice employees in order to meet the needs of patients under extraordinary or other non-routine circumstances. The regulation allows the hospice to utilize these services temporarily without a waiver or exemption from the State Survey Agency (SA) or the CMS Location.
- Compliance Determination: CMS is updating previous guidance that the hospice agency must notify the CMS of its use of contracted staff during extraordinary circumstances and submit justification for such use to its SA or CMS Location. This notification/justification is not required by 42 CFR 418.64. Compliance with the regulation for use of contracted staff is reviewed as a part of the routine survey process.
- Hospice Responsibility: When contract services are utilized, the hospice agency maintains all professional, financial and administrative responsibility for the services.
- This policy memorandum supersedes previously issued SC17-01-Hospice.
New PEPPER target area for Part D claims
Next year, the Hospice Program for Evaluating Payment Patterns Electronic Report (PEPPER) will have a new target area — the average number of Part D claims for beneficiaries billed during hospice episodes as a portion of all hospice episodes that have been discharged during the reporting period.
This, of course, is related to CMS’s ongoing concern about hospice coverage of all costs/services related to the terminal condition of the patient, especially given a recent Office of Inspector General (OIG) report that estimated that Medicare paid for $160.8 million in drug costs that should have been covered by the hospice benefit. As an area of longstanding concern, the new metric will be designed to let hospices know where they stand in relation to peers. Stay tuned for this new information.
New form and revised worksheets for home health cost reporting
Next year, home health agencies will have a new cost reporting form which will be effective for cost reporting periods starting on or after January 1, 2020 and ending on or after December 31, 2020. Several of the main worksheets have been revised.
- Worksheet S-2, Part I has been changed to require disclosure of home office expenses, and providers with a home office provider number will be required to file CMS Form 287-05, which will also be required for submission by all of the individual providers in a group.
- Worksheet S-3, Part I has been changed to separately report visits and patients who receive Medicaid services. Visits will also be set forth by discipline including reporting for licensed practical nurses (LPNs), and therapy assistants.
- Worksheet S-3 – Part II related to full–time equivalent (FTE) employees is being changed to differentiate between employees (who receive a W-2) and contract labor. Agencies should be aware that this is an FTE count and not a count of individual employees.
- Worksheet S-3 – Part IV will capture data that is related to both 60– and 30–day periods which amounts to a one-time transitional issue between the Prospective Payment System (PPS) and the Patient Driven Groupings Model (PDGM).
- Worksheet S-3, Part V will be used to garner wage and benefit data for direct cost centers with separate reporting for nursing supervisors, registered nurses (RNs), LPNs, therapists, and therapy assistants, and it will be important for agencies to distinguish between employee costs and costs associated with outside contractors for each cost center.
There are more changes that emanate from these, and agencies should pay close attention to the changes that are necessary from a financial reporting perspective to be sure that all of the required detail is available for reporting. The changes can be found here, and readers should be sure to go to the last entry – Chapter 47 – T1 – Home Health Cost Report Form 1728-20.
CMS toolkit for community-based services
CMS Administrator Seema Verma recently suggested that the “COVID-19 crisis has shone a harsh light on the human costs of a long-term care system that relies too heavily on institutional services like nursing homes,” which too often are seen as the “default option” even for those who don’t require continuous round-the-clock care. Thus, CMS is proposing to shift dollars to the states in the form of its Long-Term Services and Support (LTSS) Rebalancing Toolkit.
The toolkit has four modules that will provide:
- Strategies for increasing the share of LTSS provided in community–based settings
- Assistance to states on policy and programming strategies
- Case studies of innovative programs
- Links to resources
The first module will cover the background on home and community–based services versus institutional services; the second module will address the advancement of home and community–based rebalancing strategies; and the third module will focus on current Medicaid flexibilities to support state efforts and state strategies to rebalance LTSS systems. More on the toolkit can be found here.
In closing
It’s been another month for the record books, and I expect that we may have more to come soon. At this time of year, when we think about the ways in which we are thankful, let’s not forget that there are many things that we can, and should, be grateful for. This includes families, friends, and the ability to still reach out — even if only remotely at times — to those we care about. I am grateful for all those things and the ability to keep working with industry friends and colleagues who have shown unlimited capacity for sharing what they know for the benefit of others. In fact, I am often the very appreciative recipient of an extended hand to help in interpreting many of the announcements and stories we cover in this briefing. And so, I reiterate my thanks and thankfulness for each of you — our readers and those who work to make this briefing happen every month. 2020 has been a year to remember, but better times are coming.