CDC issues amended return-to-work guidelines: Your WellSky COVID-19 Briefing
In this edition
Use the links listed below to jump between sections.
NEWS
Current cases & maps
Americans remain pessimistic about COVID-19
Mixed signals on COVID-19 data sources
Immunity may only be temporary
Postcards deliver fabricated warning of HIPAA violations
The Defense Production Act will increase tests to nursing homes
N95 masks from federal PPE stockpile are allocated to nursing homes
COMPLIANCE
Weighing our options: Do providers really need offices?
CMS offers temporary flexibilities for Review Choice Demonstration phase-in
Medical reviews and the emergence of ADRs
The inpatient-only list and why it matters
CLINICAL
New study suggests asymptomatic children could be more contagious than previously thought
New drug antibody testing for nursing home residents
ADMINISTRATIVE
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
This is our second-to-last weekly edition of the COVID-19 briefing, and starting in September, we will begin delivering these briefings on a monthly basis. Fortunately, we have some good news to report this week. On August 23, the United States completed a nine-day run of new case counts below 50,000 per day, which is the lowest since the third week of June. The U.S. now has a total of 5.7 million cases, which is an increase of 300,000 people who tested positive for COVID-19 since last week’s reporting. Deaths last week stood at 170,000, and the latest reports show 177,000. That means we are ever-so-slowly dropping under the “thousand mortalities a day” benchmark that has been troubling.
Still, the U.S. accounts for a quarter of the world’s cases, and the Centers for Disease Control and Prevention (CDC) predicts another 30,000 deaths in the next three weeks. Florida joined four other states — New York, New Jersey, Texas, and California — by passing 10,000 mortalities attributed to the virus last week.
The New York Times published another interesting interactive article that shows the trends following the case surges from June and July. It also shows how the trends in many southern states that were former hotspots have improved significantly. Everywhere that we see improvement, there are also at least some local mask mandates, and most of the states with dramatic improvements paused or reversed their reopening plans. Florida and Arizona were two states with exceptionally high positivity rates that have now started to show steep declines in infections. The bad news? Even in states with the most significant declines in positivity, we still see cases per million that outpace other areas in the world with major outbreaks. As Dr. Joe Gerald, associate professor of public health policy at the University of Arizona noted, “We basically have 50 laboratory experiments going on right now, and every state has a slightly different policy approach. If we get complacent, this thing could get out of control again. And we’ll have even less safety margin to manage it because we’re starting from a higher place.”
In the meantime, the CDC map (below) depicting states with more than 40,000 cases of COVID-19 has held steady for the last three weeks. This week, however, another state — Kentucky — stands at just over 43,000 cases.
From a weekly comparison of the New York Times graph depicting new cases per day, we can see the trend beginning to head more rapidly in the right direction.
But there are still areas where concerns are high. Another perspective on new cases by state, offered by the Wall Street Journal, shows seven states where new cases per 100,000 people remain a concern — Mississippi, Georgia, Texas, Tennessee, Alabama, Nevada, and North Dakota.
And even though new case counts are receding, deaths still represent a lagging trend — especially in Georgia, Tennessee, Iowa, Oklahoma, Kentucky, North Dakota, Indiana, Wyoming, Minnesota, Kansas, Oregon, and Hawaii.
The New York Times heat map of the United States is definitely showing much less red, with 30 states plus the District of Columbia with demonstrably lower COVID-19 case trends — Georgia, Tennessee, Nevada, Alabama, Texas, Arkansas, Florida, Idaho, Louisiana, South Carolina, Wisconsin, Utah, Virginia, Maryland, Arizona, Ohio, Washington, New Mexico, Delaware, Oregon, West Virginia, Colorado, Massachusetts, New Hampshire, and Washington, D.C.
The same map with mortality trends shows the concentration of deaths led by New York, New Jersey, Florida, Texas, and California. One thing to remember about deaths is the number of cases and attributed deaths among residents and staff of long-term care (LTC) facilities. With 420,000 cases associated with 18,000 facilities, congregate living sites have recorded 70,000 deaths, representing 40% of all recorded COVID-19 deaths in the U.S.
Finally, the Associated Press reported last week that 215,000 more people than usual died during the first seven months of 2020, lending support to the notion that deaths related to COVID-19 are, in fact, underreported. New CDC data shows that deaths among minorities, including Blacks, Hispanics, Native Americans, and Asian Americans highlight even greater disparity than originally believed. People of color make up about 40% of the U.S. population and have accounted for more than half of the “excess deaths” through the end of July, lending even more credence to the pervasive nature of structural racism in the U.S. Earlier reports highlighted the disparity related to deaths among Blacks, Hispanics, and Native Americans – the inclusion of Asian Americans is the latest finding to be revealed through analysis of the data. According to the CDC, in normal times, about 1.7 million people die in the U.S. during the first seven months of the year. The number of deaths from January through July this year was 1.9 million.
All in all, despite some concerning news, the trends are improving even though we are not yet where we had hoped to be as fall approaches. With just a little bit of luck, we will be able to report more strides toward nationwide control of the outbreak next month.
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News
Americans remain pessimistic about COVID-19
In a series of surveys over the last week, we learned that even though there are small glimpses of improvement here and there, many Americans remain pessimistic about COVID-19. In a recent poll conducted for CNN, 55% of people surveyed believe that the worst is yet to come from the pandemic. That percentage is up ten points from a similar survey conducted in early June. Only 40% believe that the worst is behind us. Just over half (52%) of people surveyed are not yet comfortable with returning to their regular routines based on what they know about COVID-19 trends in their local areas. More than a third of respondents do not believe that their regular routines will be restored by the end of the year. Only 56% would try to get the vaccine and 40% would forego the vaccine even when it is offered.
At the same time, physicians aren’t wildly optimistic either. A recent survey conducted by the Physician’s Foundation shows that about half of the 3,500 physicians surveyed believe that COVID-19 will not be under control until at least June 2021. It is noteworthy that, of these physicians, two-thirds were primary care providers.
Mixed signals on COVID-19 data sources
There are many reasons why post-acute providers should care about hospitalization data. In normal times without §1135 waivers, skilled nursing facilities (SNFs) get Medicare patients following hospital inpatient stays. Home health providers are very interested in hospitalization rates because that metric influences the number of institutional admissions that could be coming their way. And hospices are interested too, because it is often during a hospitalization that patients are encouraged, with their family members, to engage in advance care planning that often leads to hospice elections in lieu of aggressive therapeutic interventions.
With these interests in mind, we took note that on August 20, the Wall Street Journal reported that the U.S. Department of Health and Human Services (HHS) reversed the course set in mid–summer, sending responsibility for data collection regarding hospital inpatient and ICU bed capacity back to the CDC. In the same week, Dr. Deborah Birx, a member of the White House Coronavirus Task Force, announced a new, revolutionary data system being developed by the CDC “relevant to treatment and [availability of] PPE.” The change from CDC to HHS for reporting was initially represented as a means of determining where to distribute remdesivir (a COVID-19 anti-viral). But hospitals have complained that the data, as published, is not always current or accurate and thus detracts from regional capacity planning, which is vital in hotspot areas. Nonetheless, HHS disputed the Wall Street Journal report and said that data reporting would remain with HHS and that the data would be housed in a new system being built by a private contractor, TeleTracking Technologies (TeleTracking).
On August 24, the New York Times reported new information about the back-and-forth around data capture and reporting, noting that during the third week of April, HHS Secretary Alex Azar required hospitals to make a one-time report of their COVID-19 admissions and ICU beds to TeleTracking , which had recently been given a five month contract to develop a new reporting system. The instructions from HHS tied receipt of Provider Relief Funds to the data reports, indicating that submitting the data would be a prerequisite to receiving relief funds. This, of course, was not originally included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act as passed by Congress.
In the meantime, the CDC is apparently continuing to track hospital data even though there has been a decision by officials there to forego analysis and publication of the TeleTracking data due to concerns around accuracy and data quality. HHS is reporting at least some of the TeleTracking data on the HHS Public Protect Data Hub. As this goes on, the CDC is collaborating with the United States Digital Services to develop data flow processes that would enable sending data to HHS.
Immunity may only be temporary
According to new findings, immunity to COVID-19 acquired after exposure and a positive test may only be temporary. According to researchers in Hong Kong, immunity may only last a few months, based on cases recorded in areas where COVID-19 infections are resurfacing several months after an initial episode of the virus. The particular case that led to the most recent cautionary report concerned a young man in his thirties who traveled to Spain after first contracting and recovering from the virus earlier this year. Upon his return, the strain of the virus he came home with closely matched the strain circulating in Europe at the time. Physicians in the U.S. have reported on reinfections as well, but without the rigorous testing that has been performed elsewhere. It is well known that common cold coronaviruses can reappear in less than a year, but researchers were hoping that COVID-19 immunity would last longer.
Postcards deliver fabricated warning of HIPAA violations
Recently, HHS alerted providers that fake postcards warning of HIPAA violations are being circulated. The postcards appear to be from the HHS Office of Civil Rights (OCR). OCR became “aware of postcards being sent to healthcare organizations disguised as official communications, claiming to be notices of a mandatory HIPAA compliance risk assessment.” The postcards carry a Washington, D.C. address, reference the “Secretary of Compliance, HIPAA Compliance Division,” and urge addressees to visit a website link to take action on HIPAA requirements.
OCR indicates that entities, as well as their business associates, should be aware of the issue and should alert members of the workforce regarding information that is false and misleading, noting that OCR would not send out any type of communication with an address other than its own. An image of the fake postcard is shown below for reference.
The Defense Production Act will increase tests to nursing homes
Last week, HHS said that it will invoke the Defense Production Act in an effort to ship more tests and supplies to nursing homes. Two companies — Becton Dickinson and Quidel Corporation — have been chosen to lead the effort. Becton Dickinson will provide 9,000 testing devices, and Quidel will provide the rest of the 11,000 to 14,000 devices that are needed. Facilities will receive testing units and supplies from only one of the two suppliers because the systems are not “cross compatible.”
N95 masks from federal PPE stockpile are allocated to nursing homes
Along with new testing initiatives for nursing homes, the federal government is also opening up its stockpile of PPE to nursing homes and other providers. Some of the distribution of N95 masks will be done through the open marketplace and will not come directly from the federal government. The national stockpile currently has 44 million N95s, with another 500 million on order, according to Bloomberg Law. The move is expected to result in shipment of 7 million N95s to healthcare workers “who are again rationing and reusing masks and gowns.” According to the American Health Care Association and National Center for Assisted Living, about one-fifth of nursing homes told the CDC that they either had no inventory of PPE or less than a seven-day supply on hand in mid-July.
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Compliance highlights
Weighing our options: Do providers really need offices?
An article I read in Home Health Care News last week suggests that offices intended to house administrative functions of home health agencies may no longer be practical now that many have had unexpected success working remotely. The article’s author writes that “if home-based care operators believe they should keep brick and mortar offices, they’ll have to make a compelling case as to why.” The article quotes several home health leaders who are affiliated with large organizations with multiple offices. For these providers, the consolidation of operating locations is logical. However, the article infers that this option is available for all agencies, when that may not be the case. While we may think we can run a home health agency from multiple remote (often home office) locations, CMS might respectfully disagree — especially in terms of conducting surveys.
We should remember that all home health agencies are subject to periodic routine surveys, as well as surveys that are conducted in response to a complaint. Surveys are carried out at business locations with regular operating hours and with the expectation that certain key staff members, including an administrator or alternate administrator, and other staff who can support the survey activity will be present and available. When they arrive, surveyors expect to find that the agency has a physical location that is accessible during regular operating hours where, among other things, medical, financial, and personnel records are stored and protected.
In the State Operations Manual concerning survey and certification activities that are carried out by state agencies, CMS notes that without knowing the whereabouts of the provider’s office location, “CMS has no way of carrying out its statutorily mandated obligation of determining whether the provider is complying with applicable participation requirements.” The guidance to surveyors goes on to note that “it is longstanding CMS policy that there is no basis for a provider to bill Medicare for services provided from a site or location that has not been determined to meet applicable requirements of participation.” So, before we start to think that agencies can ditch the office for working from home, a review of the State Operations Manual might be a worthwhile endeavor. Don’t walk out on that office lease just yet!
CMS offers temporary flexibilities for Review Choice Demonstration phase-in
On Friday, August 21, CMS released new information about the phase-in of Review Choice Demonstration (RCD) in Florida and North Carolina.
In the update, CMS notes that it will provide flexibilities on RCD “for a limited period of time” to help ease the transition during the current public health emergency. The approach will be re-evaluated in 60 days. For agencies in North Carolina and Florida, that means the following:
- Providers may submit pre-claim review requests for billing periods starting August 31, 2020.
- Claims that go through pre-claim review and are submitted with a valid Unique Tracking Number (UTN) will generally be excluded from further medical review.
- Claims submitted without going through the RCD process will be paid as usual and will not be subject to a 25% payment reduction. But these claims could be subject to post-payment review in the future.
- Providers who have already made a choice selection do not need to take any further action if they choose not to participate.
For providers in Illinois, Ohio, and Texas where RCD is already operational, CMS announced that:
- Cycle 2 in Illinois and Cycle 1 in Texas will end on September 30, 2020.
- Affirmation and claim approval rates will be calculated based on review decisions made between February 1, 2020 and September 30, 2020 for Illinois providers and between March 2, 2020 and September 30, 2020 for Texas providers.
- Cycle 2 in Ohio will begin on August 31, 2020, as previously noted.
- Claims submitted under Choice 1 without going through the pre-claim review process will not be subject to a 25% payment reduction until further notice but will be subject to prepayment review.
Medical reviews and the emergence of ADRs
CMS suspended medical review during the early days of the public health emergency but restored it as of August 3, 2020. We are now aware of additional documentation requests (ADRs) that are starting to emerge and, as I’ve mentioned, there is no reason to think that the public health emergency will inhibit medical review from here on.
Agencies should resume their weekly (or daily) reviews of claims with a status code of S B6001, which is indicative of an ADR in process. According to the National Association for Home Care and Hospice (NAHC), as of August 21, both Palmetto and CGS had issued guidance regarding medical review. National Government Services (NGS) has not yet posted its information to its website. Following is the synopsis of what CGS and Palmetto have to say about their plans:
CGS:
- Home health reviews will relate to questions of medical necessity with the Reason Code 5L000. Claims with between 2 and 6 visits (just over the LUPA thresholds), a diagnosis code of I11.0 (hypertensive heart disease with heart failure), Z46.6 (encounter for fitting and adjustment of a urinary device), J44.1 (COPD with acute exacerbation), J44.9 (COPD unspecified), I10 (essential primary hypertension), G20 (Parkinson’s Disease), I25.10 (atherosclerotic heart disease of native coronary artery without angina pectoris), N39.0 (urinary tract infection), J18.9 (pneumonia, unspecified organism), or I87.2 (chronic venous insufficiency), and submission dates prior to March 1, 2020 will be targeted for review. Given the focus on visit counts, we can assume these will be PDGM claims submitted and paid in 2020 prior to the public health emergency.
- Hospice medical review will follow home health medical review and CGS will post information when reviews are slated to begin.
Palmetto:
- Home health reviews will be focused on medical necessity through a review of inpatient claims that resulted in home health services.
- Hospice services will also be focused on medical necessity for General Inpatient Services for care over seven or more days with Revenue Code 656 and a Place of Service between Q5004 and Q5009.
The inpatient-only list and why it matters
I read an interesting article in RACmonitor last week written by Ronald Hirsch, MD, titled The Demise of the Medicare Inpatient-Only List – The Myths and Facts. The article has good information for all post-acute providers. As I have said many times, it behooves all post-acute providers to be aware of what is going on in other parts of the industry because, like it or not, there is a definite “trickle down” effect on us. This topic certainly qualifies as one worth watching given that SNFs (in normal times when there are no waivers) and home health agencies (for which reimbursement changes depending on the origins of the patient) should be vitally interested in what is happening in other segments of health care.
As I reported in an earlier version of the weekly briefing, CMS intends to dispense with the inpatient–only list (IPO) in the next three years. The IPO list has existed for about 20 years and it was first designed to identify surgical procedures which, due to their invasive nature, would require at least 24 hours of post-op recovery in hospital. Twenty years ago CMS concluded that such surgeries could only be performed as inpatient services to be eligible for payment. Now, CMS has changed its mind. Here are some excellent takeaways from Dr. Hirsch’s article:
- There is no clinical difference between surgeries that are performed in a hospital as inpatient procedures versus those performed on an outpatient basis. The only difference is in how they are billed . . . and how an outpatient designation can affect the patient’s eligibility for inpatient rehab at a SNF or how the outpatient designation changes home health reimbursement from an Institutional Admission Source to a Community Admission. The patient is the same. Eligibility and payment for post-acute services is not the same.
- When it comes to procedures that are eligible for ambulatory surgery centers (ASCs), there is a difference because there is supposed to be less risk for complications and/or protracted recovery times. As with other outpatient procedures paid by traditional Medicare, these generally preclude recovery at a SNF (due to the lack of an inpatient stay) and will be reimbursed at lower rates for home health under traditional Medicare. Importantly, Medicare Advantage plans are not bound by the same rules that extend to traditional Medicare and, for them, any surgical procedure can be performed at an ASC if the physician is comfortable with the risk of doing it there.
- Elimination of the IPO does not mean that all surgeries will become outpatient procedures. As the IPO list is eliminated, there will continue to be reliance on the physician’s designation of the patient’s admission status which relies on the two-midnight rule and case-by-case exceptions if and as they apply. These are the guidelines that have been in place relative to knee replacements since 2018 and which have caused confusion for many, including home health agencies admitting patients with total knee replacements as PDGM got underway.
Elimination of the IPO is not a death knell for SNFs. Medicare requires that a patient be hospitalized as an inpatient for three days not counting the day of discharge to be eligible for inpatient SNF care; however, in 2018 the rule was changed so that if the physician determines that there are specific reasons for post-discharge care in a SNF, the physician should document their rationale and admit the patient as a hospital inpatient which clears the way for a discharge to SNF care.
- At the end of the day, it is the physician who determines the patient’s hospital admission status. This means, at least in theory, that when a home health agency receives a patient referral following a surgical procedure and the patient’s discharge summary indicates that the stay was, indeed, an inpatient stay, that should be enough to code the claim as an Institutional Admission without worrying about what the hospital’s billing department might do with the claim.
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Clinical highlights
New study suggests asymptomatic children could be more contagious than previously thought
On August 20, Massachusetts General Hospital released a new study showing that children can have high levels of COVID-19 in their noses and lungs during the first three days of infection — even though they may have mild or no symptoms of the virus. Because of this they may be more, not less, contagious than recently thought. Children have tended to exhibit very few symptoms and were largely ignored during the early days of the pandemic. However, new evidence suggests that they could become “silent spreaders.” Still, children are not protected from the virus, even though their symptoms may be mild. Other takeaways from the article include the following:
- Of the 192 children seen at Massachusetts General, 49 were diagnosed with acute infections and 18 with multi-inflammatory syndrome linked to COVID-19. The average age of the children was 10, and 25% tested positive for COVID-19.
- Age did not impact viral load or the amount of virus present in children. Viral load appeared to be especially high during the first two days of infection.
- Many have hypothesized that ACE2 immune receptors are less prevalent in children, thus conferring some level of immunity against COVID-19. However, the study found that while younger children do have lower numbers of receptors than older children and adults, their viral loads were not reduced as a result.
- Another study out this month from the Children’s National Hospital in Washington studied 177 children with COVID-19 and found that the youngest and oldest were more likely to be hospitalized and the oldest children more likely to require critical care in an ICU.
- Asthma is the most common underlying diagnosis in children with COVID-19; however, children with asthma “were not overrepresented in those who were hospitalized or critically ill.”
New drug antibody testing for nursing home residents
According to the New York Times, new research sponsored by Eli Lilly and the National Institutes of Health (NIH) is aimed at nursing home residents, who make up 1.2% of the population and 40% of COVID-19 infections. The experimental drug being used in the study is a monoclonal antibody. In this case, the antibody was artificially cloned from those found in the blood of a Seattle man who was one of the first to be infected with and survive COVID-19. Regeneron Pharmaceuticals, a biotechnology company, is also conducting clinical trials using monoclonal antibody therapy. The Eli Lilly/NIH study will involve 2,400 residents and 500 facilities. About 125 facilities have signed up thus far, and the company intends to enroll between 40 and 80 participants at each site where testing will be conducted.
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Administrative highlights
CDC issues amended return-to-work guidelines for healthcare workers
The CDC recently issued amended Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection. In essence, the CDC now recommends that healthcare workers with “severe to critical illness” or those who are immunocompromised be issued an extended work exclusion. Prior guidance granted an extension lasting 10 days. CDC guidance has now doubled that time, granting 20 days. Human resources staff should acquire the updated documentation and consider implementing it.
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In closing
Keeping up with a small avalanche of COVID-19 information every week has had its moments. Some weeks, I revisit prior editions of the briefing to remember what is new and what I’ve already written about. Other weeks, there is so much to master that I feel almost like a hamster on a wheel with a newspaper in hand trying to pack my brain with more information than it can hold. It has been a challenge on occasion! This last week, I found an amazing National Geographic article about a small bird that weighs about a quarter of a pound with a brain that would challenge any one of us. Clark’s nutcracker (the bird’s name) has, at any given time, somewhere between 5,000 and 20,000 “maps in its head” that show where seeds, usually two or three at a time, are buried. With this information and these little mental “maps,” this bird will have food available in different locations for about nine months. It starts in summer when whitebark pine trees produce seeds in cones that are harvested by the nutcrackers as they take the cones apart. The bird stores the seeds under the tongue and buries them, a few at a time, resulting in 20,000 or so little stashes of seeds for the future. They don’t quit until it gets too cold and then they rest, and apparently enjoy the winter feast. Quoting the author, “Whatever it is they do, I want what they’ve got.” Me too. Here is a link to the article. Read and be amazed.
As we work through another week, my wish for all of you remains unchanged. I hope you are able to stay safe, happy, and healthy out there. My thoughts are, as always, with you.