HHS officially extends the public health emergency and its related waivers: Your WellSky COVID-19 Briefing
In this edition
Use the links listed below to jump between sections.
NEWS
COMPLIANCE
HHS extends the public health emergency
HHS dramatically lowers threshold to report relief funds
Fraud, abuse, and Medicare overpayments
OASIS waiver clarification
CLINICAL
Home health quality public health emergency tip sheet
Calls to delay the Hospice Medicare Advantage carve-in
Advance care planning
SNFs experiencing shortages of PPE and staff
OSHA safety complaints
Asymptomatic transmission of COVID-19 in SNFs
ADMINISTRATIVE
On Monday, July 27, the World Health Organization declared that COVID-19 is “easily the most severe global health emergency” in history. According to historical information from the Centers for Disease Control and Prevention (CDC) about the 1918 flu pandemic, more than 675,000 people in the United States died in connection with the outbreak, and there was an unusually high infection and mortality rate among previously healthy people — including those between the ages of 20 and 40. With the mortality rate as the only exception thus far, it seems like much of this history is repeating itself.
____________________
News
Current cases & maps
The CDC’s most recent map of reported COVID-19 cases shows that three new states have now reached more than 40,000 COVID-19 cases: Iowa, Missouri, and Nevada. A total of 29 states now have more than 40,000 cases each.
Last week at press time, we reported a total of 3.8 million COVID-19 cases in the U.S., which represented an increase of 400,000 cases. Again this week, we report an increase of more than 400,000 cases, bringing the total to nearly 4.3 million. There are now 148,000 reported mortalities — an addition of 8,000 in the last week. Since the end of June, the case count has doubled; mortalities have grown by 21,000. However, the average number of new cases per day has leveled off at 66,000, which has led some experts to suggest that individuals in many states are back to exercising more precaution and staying home.
Last week, both California and Florida replaced New York as the states with the highest case counts. California now leads the nation with more than 459,000 cases, followed by Florida at 424,000 and New York at 416,000. Texas, which now has nearly 382,000 cases will exceed New York in the next week — even if the case growth slows down. In the meantime, 43% of the growth in cases last week came from the 10 states with the highest rates of growth (not case counts): Louisiana, Mississippi, Alabama, Nevada, Tennessee, Georgia, Arkansas, California, Oklahoma, and Missouri.
As we take another look at the map produced by covidexitstrategy.org, Oregon is the only state that has shown improvement. North Dakota and Missouri both descended to “uncontrolled spread” status. No additional states reached the “green zone” for improving trends.
The graphs from the New York Times below show new case trends and mortalities. Since July 17, the average number of new cases per day has been above 65,000. The mortality count has been steadily rising each day since July 7, with the only exceptions being weekend days, when not all states report data.
The heat map from the same data set maintained by the New York Times shows little change since our last briefing. However, more than 73,500 cases were recorded on Friday, July 24, and 18 states set single-day new case records in the last week: Alabama, Alaska, California, Hawaii, Indiana, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, New Mexico, North Carolina, North Dakota, Oklahoma, South Carolina, Utah, and West Virginia. Also by Friday, July 24, the number of hospitalized COVID-19 patients reached 59,670, which was a mere 270 short of the April 15 record. Significant, widespread hotspots continue to punctuate the Southeast and Far West.
Last week, just as we were going to press, the U.S. Department of Health and Human Services (HHS) unveiled its new website with maps and data depicting hospitalization rates and ICU capacity based on reports from 4,500 hospitals. It’s interesting that the states with high ICU occupancy do not necessarily correspond to those with the highest outbreaks.
Finally, CNN has published a map depicting the 30 states with mask orders. The list has grown by two states in the last week.
The week in brief
Other important developments from the week:
- The U.S. has granted contracts to several companies for vaccine development, including almost $2 billion going to Pfizer and a smaller German company, BioNTech. Safety trials are scheduled to begin this month, and the companies have indicated their ability to produce 100 million doses relatively quickly. Safety reviews are scheduled for October. Also, Moderna and the National Institutes of Health (NIH) started the Phase 3 clinical trial of Moderna’s vaccine, with 89 sites for test participants to receive vaccinations. As we reported last week, Moderna has said that it will be able to manufacture 500 million doses of its vaccine in 2021.
- On Tuesday, July 22, the White House privately warned 11 cities that they must take aggressive action to curb the spread of the virus. The cities were Baltimore, Cleveland, Columbus, Indianapolis, Las Vegas, Miami, Minneapolis, Nashville, New Orleans, Pittsburgh, and St. Louis.
- Becker’s Hospital Review reported last week that Starr County Memorial Hospital in South Texas announced the implementation of its ethics and triage committees as the hospital ran out of beds and staff. The committees will determine the intensity of care required by new COVID-19 patients and the likelihood of their survival. Those who are thought to be too fragile, sick, or elderly to survive are being advised to return to their homes to be with loved ones rather than dying “at a hospital thousands of miles away.” Early in the pandemic, we heard similar stories about preparation for ethics decisions from New York and Illinois hospitals which, to the best of my knowledge, never had to implement them.
- Governor Gavin Newsom of California announced last week that a “robust testing regimen” will begin for state surveyors who are visiting nursing homes. This follows an investigation by the Los Angeles Times which revealed that surveyors were not always being tested prior to facility inspections. California will now require the same testing standards for surveyors as it imposes on nursing home employees and other visitors, including those entering to treat hospice patients.
- Based on a recent study it funded, the CDC is again opining on the number of actual COVID-19 cases versus testing results with larger numbers. Previously, the agency indicated that the total may be up to 10 times higher than reported. However, on Tuesday, July 21, the CDC indicated that the actual rate of positivity could be “six to 24 times higher” than the reported case counts. The study notes, “For most sites, it is likely that greater than 10 times more . . . infections occurred than the number of reported cases.” The data also shows that New York City, even with its high case count, is still far “from achieving herd immunity.” The CDC-funded study was published on the JAMA Internal Medicine Network. In another study published on July 21 by the Journal of the American Medical Association, the COVID-19 epidemic is described as largely “undetected, uncertain and out of control.” Using blood samples from routine testing of over 16,000 persons between March 23 and May 12, different authors reached the same conclusion as to true infection rates. A conclusion of both studies is that so-called herd immunity will not pose substantial impediment to the ongoing spread of COVID-19. There is also increasing evidence that acquired immunity may be short-lived, especially for individuals with mild or asymptomatic infections.
- Finally, according to the Washington Post, several southern cities, including Miami and Houston, are facing significant healthcare worker shortages as infections continue to rise. A total of 39 Florida hospitals have requested state help in finding nurses and respiratory therapists. Louisiana has also requested hundreds of healthcare workers from the Federal Emergency Management Administration (FEMA) to address its staffing shortfall. Reports out of Oklahoma indicate that a patient was forced to wait nine hours for a hospital bed on July 22. The executive director of the Tulsa Health Department indicated that the issue is not bed capacity, it is “staffing to man each bed so that patients can be taken care of.” As a result of the shortage, Texas and 32 other states have joined a licensure compact that allows nurses to practice across state borders. But even with that, recruitment efforts are falling short. The map below shows the states that are currently parties to the compact agreement.
New Congressional Action on an additional stimulus package
As reported in our previous briefings, Congress continues to work on an additional stimulus package. The Democrats’ version provided for $3 trillion in relief and was rejected by Republicans on arrival. From the Democrats’ point of view, the following provisions were deemed important:
- Relief for state and local governments hit hard by revenue losses due to the pandemic.
- Another round of direct payments to individuals of $1,200, plus additional payments for dependents up to $6,000 per household.
- Hazard pay for essential workers.
- Extension of the federal unemployment benefits at $600 per week.
- $75 billion for additional COVID-19 testing.
- $175 billion for rent, mortgage, and utility assistance to individuals.
- $10 billion for additional disaster assistance to small businesses.
- Creation of a special Affordable Care Act (ACA) enrollment period for those who lose health insurance benefits during the pandemic.
The Republican version, dubbed the Health, Economic Assistance, Liability Protection and Schools (HEALS) Act, amounts to $1 trillion in proposed expenditures. The Republicans appear to have jettisoned relief for state and local governments, hazard pay provisions, rent/mortgage and utility relief, additional small business disaster funding, and the additional ACA enrollment period. It does include for the following:
- Opportunity for second round Paycheck Protection Program loans for small businesses with fewer than 300 employees and revenue losses due to the pandemic equal to or greater than 50%. Funds earmarked for this program amount to $190 billion.
- A liability shield that protects healthcare providers from COVID-19-related lawsuits except in cases of gross negligence or intentional misconduct.
- Extensions of repayment obligations for Accelerated Advance Payments which were offered early in the public health emergency through the Medicare Administrative Contractors (MACs). Home health and hospice providers that took advantage of those advances on claim payments would begin repayments in August. The new repayment start date would be January 1, 2021 under the Republican version of the stimulus.
- Extension of telehealth flexibilities until the end of 2021 or the end of the public health emergency, whichever occurs later.
- $16 billion for COVID-19 testing, some of which would be directed to nursing homes that have weekly testing obligations under new HHS and CMS mandates. There is also $26 billion earmarked for vaccine development.
- An additional $25 billion in grant funding through the Provider Relief Fund for healthcare providers.
- Direct payments of $1,200 to individuals and $2,400 to couples, with no change in the eligibility requirements.
- Unemployment benefit extensions but with reduced funding of $200 per week, moving to 70% of a worker’s prior wage.
It’s important for providers to clearly understand that negotiations are continuing. I will report on new developments next week.
____________________
Compliance highlights
HHS extends the public health emergency
On Friday, July 24, the Secretary of HHS extended the public health emergency for another 90 days. This will take us until October 22, 2020. Many expect there will be at least one more extension which would last until January 20, 2021. This extension allows the current waivers that remain in effect to continue for the duration of the declared emergency.
HHS dramatically lowers threshold to report relief funds
Last week, in yet another surprise, HHS released additional information on its “Post-Payment Notice of Reporting Requirements.”
The surprise comes from the change in the reporting threshold. The threshold was previously set at $150,000 from all sources of COVID-19 relief, presumably including funds emanating from other programs. The threshold has now been dropped to $10,000. So, if your agency received at least $10,000 in Provider Relief Funds, you should expect to honor the reporting requirement. HHS will release the reporting details on or about August 17, and the reporting system will be operational on October 1.
According to the release, all providers who received at least $10,000 in Provider Relief Funds must report for expenditures related to COVID-19 through December 31 within 45 days of the end of calendar 2020. For providers who can account for either revenue losses or excess expenditures related to COVID-19, a single report can be submitted on or after October 1, 2020, but not later than February 15, 2021. For providers that have not yet accounted for the full amount of funding received, a second report will be required no later than July 31, 2021.
According to the most recent Provider Relief Fund data released by HHS, approximately 2,400 hospices have attested to receipt of funds that totaled $826 million with an average of $342,000 per agency. Approximately 3,600 home health providers received a total of $573 million in funding with an average of $156,000 per agency. Of those providers who received funds, 177 hospices (7%) and 556 home health agencies (15%) attested to receiving $10,000 or less.
Fraud, abuse, and Medicare overpayments
Last week, federal government agencies made two announcements concerning fraud recoveries and program overpayments.
First, HHS reported in the Health Care Fraud and Abuse Control Program Annual Report that $2.6 billion was recovered in 2019 as a result of fraud investigations under the joint direction of the Office of the Attorney General (OIG) and HHS. The Department of Justice opened more than a thousand new criminal fraud investigations — with criminal charges in nearly half of the cases that involved more than 800 defendants. There were another thousand civil cases opened, thus ending the year with about 1,300 pending cases. The OIG’s office joined in too, bringing 747 criminal actions against individuals or entities that engaged in criminal behavior related to Medicare and/or Medicaid. About 2,600 individuals were excluded from participation in Medicare and other federal healthcare programs.
Then, on Friday, July 24, the OIG announced its conclusion that CMS could have saved $192 million in 2017 by better targeting episodes with visit volume slightly above the “LUPA plus one” threshold. This came from a review of a mere 120 claims with between five and seven visits in an episode. Twenty-five of the reviewed episodes were found to lack medical necessity amounting to improper payments of $41,613. The OIG based its overpayment estimate on sample results like these.
This may be a good time for a reminder that medical review activities will be resurrected on August 3.
OASIS waiver clarification
In the second quarter OASIS Q&As from July 22, CMS clarified its intent concerning the two waivers that apply to OASIS completion and submission. Question 3 addresses the waivers.
QUESTION 3:
Some patients are refusing to allow agency staff into their homes due to the current COVID-19 situation, so agencies are having difficulty completing Recertification comprehensive assessments with OASIS on time. The COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers indicates CMS is extending the 5-day completion requirement for the comprehensive assessment to 30 days and waives the 30-day OASIS submission requirement. Do these waivers and extensions apply to just the SOC OASIS, or to OASIS completion and submission at all timepoints (i.e., SOC, ROC, follow-up, recertification, discharge)?
ANSWER 3:
The “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” document states: “CMS is providing relief to HHAs on the timeframes related to OASIS Transmission through the following actions below:
- Extending the five-day completion requirement for the comprehensive assessment to 30 days. This document is intended to provide guidance on OASIS questions that were received by CMS help desks. Responses contained in this document may be time-limited and may be superseded by guidance published by CMS at a later date.
- Waiving the 30-day OASIS submission requirement. Delayed submission is permitted during the PHE.”
____________________
Clinical highlights
Home health quality public health emergency tip sheet
Last week, CMS posted a COVID-19 Public Health Emergency Tip Sheet related to home health quality reporting requirements (HH QRP).
As I previously reported, the HH QRP exception waiver that was granted on March 27, 2020 expired on June 30. This exempted agencies from the need to gather and report data for the fourth quarter of 2019, and the first and second quarters of 2020. Beginning July 1, agencies are required to resume data collection and submission.
Consumer Assessment of Healthcare Providers and Systems (CAHPS) data is required for the third quarter and onward, and agencies are reminded that the annual payment updates run from April through the following March. Related to the 2022 annual payment update, providers must have submitted data for three of the four quarters in the April 2020 to March 2021 annual period – the quarter beginning April 1 and ending June 30 is exempt from the data submission requirement. CAHPS submissions are required as of the third Thursday of January, April, July, and December. Due to the exception, CAHPS submissions were to be resumed on July 16.
Calls to delay the Hospice Medicare Advantage carve-in
On July 22, Hospice News reported that there will likely be legislation introduced in the coming days/weeks that will seek to delay the January 1 Medicare Advantage (MA) carve-in of hospice benefits, perhaps until 2023. Last year, the National Hospice and Palliative Care Organization, among others, advocated for a delay. Recently three members of the House Ways and Means Committee — Representatives Adrian Smith (Nebraska), Jackie Walorski (Indiana) and Terri Sewell (Alabama) — wrote to CMS requesting a one-year delay. NAHC also supports the delay and Theresa Forster, NAHC’s vice president for hospice policy, noted that “if this experiment is implemented prematurely or without appropriate preparation by both the MA plans and hospices, it will pose significant risks to hospice patients who need the full scope of hospice care at the end of life. Any shortcomings in care for these most vulnerable of patients cannot be corrected after the fact.” On the other hand, the Better Medicare Alliance, which refers to itself as the “leading research and advocacy organization supporting Medicare Advantage,” responded that any further “delays would be untenable and unnecessary.” I will continue to follow the issue for updates in the coming weeks as the debate goes on.
Advance care planning
A recent study published in the Journal of Palliative Medicine suggests that perception of advance care planning, as well as public attitudes and lack of awareness of hospice, stand in the way of meaningful progress toward advance care planning for many. The study, entitled Public Perceptions of Advance Care Planning, Palliative Care and Hospice: A Scoping Review involved about 9,000 participants. It showed that more than 80% knew about the concept of advance care planning, even though only 10% had identified a healthcare proxy and only about 40% had documented advance care plans. Many were unable to differentiate between end-of-life and palliative care. The conclusion of the study is that a campaign directed at public engagement as a means of expanding an understanding of palliative and hospice care is needed. I suspect that most hospice leaders would agree.
SNFs experiencing shortages of PPE and staff
A Kaiser Family Foundation issue brief on rising COVID-19 case counts in skilled nursing and other long-term care facilities notes that over a 14-day period that ended on July 10, COVID-19 cases among facility residents increased by 11%, overall, in 35 states.
The brief goes on to note that in the 23 hotspot states, the case count among residents rose by 18% over 14 days, moving from 123,000 cases to 144,800 cases. Cases in non-hotspot areas only rose 4% over a similar 14-day measurement period. This suggests a clear connection between widespread community transmission and long-term care cases “despite the precautions in place in most long-term care facilities.”
The states with the highest overall increases were Texas and Florida, both of which reported a 50% increase in nursing home cases between June 24 and July 9. “Experts have attributed these spikes to their quick pace of reopening, lack of social distancing measures such as face mask requirements, and increased population movement due to warmer weather,” although the increase among nursing home residents is also likely the result of more widespread testing. The study also found that personal protective equipment (PPE) shortages and/or inadequate staffing in one of every three nursing homes was also a contributing factor to the rise in cases. By June 28, 3,000 nursing homes were short of staff and about 2,700 were also short on PPE, including N95 respirators, surgical masks, eye protection, gowns, gloves, and hand sanitizer. There was very little difference between states that were considered hotspots and those that were not.
OSHA safety complaints
The Occupational Safety and Health Administration (OSHA) issued a hazard alert and citations for a nursing home operator in Ohio for “a serious violation of two respiratory protection standards including failing to develop a comprehensive written respiratory protection program and failing to provide medical evaluations to determine employees’ ability to use a respirator in the workplace.” In connection with the citations, the company received $40,482 in penalties which are under appeal. The investigation found that even though the company was making efforts to protect employees from COVID-19, it had not fully implemented an appropriate respiratory protection program. The investigation also raised the issue of re-use of N95s for up to a week noting that repeated use carries a significant risk of contact transmission. In its defense, the company noted that it had spent significant funds to acquire PPE, but it was unable to obtain fit tests until recently. OSHA has also recently cited at least one nursing home for record-keeping violations.
Asymptomatic transmission of COVID-19 in SNFs
A new article published by Oxford University Press for the Infectious Diseases Society of America focuses on what happened with 97 residents of a skilled nursing facility (SNF) when they were relocated due to a decision to use the facility as a COVID-19 rehabilitation center. At the time of the relocation there were no confirmed or suspected cases of COVID-19 among the residents. Within days, 85% tested positive for the virus even though there were strict visitation and staff screening protocols in place. Within two weeks, 30 residents had died. Nearly 40% of staff also tested positive but were not tested until five days after residents had been tested. The study arrives at the same conclusion recently publicized by HHS: nursing home residents and staff must be formally and regularly tested. “Simply screening for symptoms is no longer enough.”
____________________
Administrative highlights
More relief for nursing homes
On July 22, HHS announced it will send an additional $5 billion to SNFs to address what the administration determined to be critical needs, including hiring additional staff, testing, and technology support that will enable residents to connect with family members. This funding is in addition to other prior disbursements from the Provider Relief Fund related to Medicare and Medicaid services. The announcement did not include how funding will be established but will target nursing homes “in hotspots and that are also experiencing significant case load.”
Nursing homes must participate in online COVID-19 training that includes 23 educational modules and scenario-based learning “on cohorting strategies and using telehealth in nursing homes to assist facilities as they continue to work to mitigate the virus spread.” CMS also noted that facilities with recent infection control survey citations will receive additional specialized training. CMS also expects facilities in states with a 5% or higher positivity rate to test all staff weekly as well as visitors.
CMS Administrator Seema Verma said that the mandate will require formal rulemaking which will be forthcoming “very shortly.” In the meantime, CMS will be distributing to state governors lists of facilities with rising case counts which will be meant to trigger facility inspections. The agency has already sent “Task Force Strike Teams” to facilities in Illinois, Florida, Louisiana, Ohio, Pennsylvania, and Texas.
Nursing home testing
Last week, I reported on HHS’ decision to quickly deploy rapid point of care diagnostic test instruments to 2,000 nursing homes in hotspots along with a starter supply of 400 test kits. HHS indicated last week that eventually all facilities would receive testing assistance, but the first deployment of 2,000 would be directed to hotspots. The number has dropped a bit.
HHS targeted 600 facilities for receipt of test kits last week and made it clear that additional facilities will be selected based on their location in a known hotspot or in the event of three or more confirmed or suspected cases in the previous week. In addition, facilities with one new resident COVID-19 case after having none previously and those with at least one resident death in the prior seven days or one staff case within the last seven days will be prioritized.
Moreover, the number of kits will be based on facility size.
- Small facilities will receive one device and 150 test kits.
- Small to medium facilities will receive one device and up to 250 test kits.
- Medium-sized facilities will receive one device and up to 330 test kits.
- Large facilities will also receive one device and up to 600 test kits.
- Those that are considered “major outliers” in terms of size and number of residents will receive two devices and 900 kits.
CMS reconfirmed that facilities must have Clinical Laboratory Improvement Amendments (CLIA) waivers to be eligible to receive the testing support.
In closing
It has been another stressful week. I offer the following to lighten your load at least a little.
It is a longstanding joke in our family, introduced and reinforced at every conceivable opportunity by my husband the former music major, that I have the musical taste of “a seventh grader.” I am probably guilty as charged, especially on those days when I clean house to Metallica cranked up nearly as far as the volume will go. However, I am glad to report that I have been recently, if only temporarily, vindicated by finding a video clip of Steve Martin playing with the Philadelphia Orchestra. You can watch it here. Listen and smile.
Once again, I leave you with our oft-repeated wish for you, your teams, and your families — be safe, be well, and keep your sense of humor intact. This, too, shall pass. More next week.