Appointment scheduling systems causing roadblocks in vaccination administration: Your COVID-19 Briefing
In this edition
Use the links listed below to jump between sections.
NEWS
Johnson & Johnson vaccine gets the go-ahead for emergency use
Many struggle with vaccination scheduling systems
New leadership at HHS and CMS
COMPLIANCE
CMS clarifies intent of CARES Act regulatory changes for home health
Medical necessity and documentation requirements added to hospice recovery audit topics
Comprehensive error rate testing
New OIG work plans put home health in the spotlight
CLINICAL
Counterfeit PPE: 3M to assist providers in authenticating N95 masks
FDA issues warning on pulse oximeter accuracy
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
One year ago, the alarms about COVID-19 started going off in earnest. At the beginning of March 2020, the U.S. had 16 reported cases, although we later learned that there had been more that were simply not recognized at the time. Three people had died from the virus. As the month wore on, a dozen or so states imposed stay–at–home orders with more to come — all with the intent to stop the spread of COVID-19. Many businesses were forced to close; others were forced to shift their workforces to remote status. Business travel came to a screeching halt and many of us headed out to the grocery store with panicky feelings about whether we would be able to find scarce commodities like toilet tissue and hand sanitizer. All in all, March 2020 was no fun and — mostly — things went downhill from there throughout the remainder of the year.
Nearly a year later, here we are again at the start of meteorological spring and — at long last — things are looking up even if we aren’t quite out of the woods yet. In home health and hospice parlance, if “normal” is the goal, the plan and intervention must be rooted in caution and maintained vigilance, even in our moments of pandemic fatigue.
In the last two months, the average new case counts per day have dropped from over 250,000 in early January to just 68,000 by the end of February. That represents a decline of 26% in the 14-day average. And, as more are vaccinated, the rate of serious illness requiring hospitalization is also starting to decline.
Mortality rates are also declining, with a 21% drop in deaths from the virus in the last two weeks.
The graphs present the pictures we want to see with downward trajectories, but we also need to remember that, over the month of February, the case count in the United States passed 26 million, and mortalities from the virus sailed right past 500,000 and counting — a statistic that was unthinkable a year ago.
The New York Times heatmap shows the improvement in hot spots with a rapidly diminishing number of counties in orange and red. That trend is contributing to a similar downward trend in hospitalization rates — another welcome sign.
With all that said, though, we can see from the progressive maps below — also from the New York Times’ data — that the risk of contracting COVID-19 is improving but still high, with highest risk, yet again, in the mid-Atlantic, South, and West. As we began our COVID-19 odyssey this time last year, the greatest threat was in the Northeast. Then the highest risk and case counts cycled to the South, finally moving last fall to the Midwest and West. We can only hope that the risk will be contained, although most scientists are now telling us that the COVID-19 map may always have a hint of yellow, even when things get back to what we used to call normal.
President Biden suggested early on that the federal government would encourage the use of masks but still left decisions up to the states. The map below shows the 32 states where statewide mask mandates exist — and the 18 states where there are either no restrictions or more relaxed guidelines.
In addition to encouraging the use of masks, the new administration also set a goal of 100 million people being vaccinated for the virus within the first 100 days of the administration, which would mean the end of April. As of the end of February, the daily vaccination rate across the country has reached 1.74 million people per day. Nearly 50 million people have received at least one dose of the vaccine and almost 25 million have received both doses of either the Pfizer or Moderna vaccines. There have been 96.4 million doses delivered to the states, indicating that the vaccines are, at last, getting out and into the arms of people who need them even though getting an appointment has presented challenges for many.
At the current vaccination rate, half of all eligible people in the U.S. would be vaccinated by early July. It would take until December to reach a 90% vaccination rate in the eligible population.
The map below, also from the New York Times, shows how states have fared with delivery of at least a single vaccination. In all states, healthcare workers and residents of long-term care facilities have been eligible for vaccinations for several weeks now. Also, older citizens are eligible in all states although the age ranges differ somewhat, with the age of 65 being the threshold for most. Forty-five states have occupational vaccination programs that extend to police officers, teachers, or employees of other ‘front-line’ businesses such as grocery stores. Teachers have been prioritized for vaccinations in 32 states.
As the push to get more people vaccinated escalates, one of its byproducts appears to be the drastic drop in demand for testing. According to the Associated Press, plunging demand for COVID-19 testing may leave the U.S. exposed to future outbreaks. With more than 180 government–run sites operating at less than half capacity, some sites are being closed altogether and others are trying to return supplies. Testing hit its peak in the middle of January when the country was averaging upwards of two million tests each day, but since that time, demand has dropped by more than 28%. The cause may be encouraging new case trends, dropping mortality rates, the end of winter, and pandemic fatigue. Days-long wait times for getting results back have also contributed to the drop in interest. Nonetheless, most indicate that testing should still be a priority and we will need ways to keep interest in test results up as we confront the possibility of surges in new cases.
NEWS
Johnson & Johnson vaccine gets the go-ahead for emergency use
On Saturday, February 27, the U.S. Food and Drug Administration (FDA) authorized the use of the Johnson & Johnson vaccine. The next day, the Centers for Disease Control and Prevention (CDC) also voted in support of the vaccine’s deployment in the U.S.
The three vaccines now available for use in the U.S. compare as follows:
Source: Wall Street Journal March 1, 2021
Johnson & Johnson said that it will ship about four million doses immediately with another 16 million slated to be shipped by month’s end. By the end of June, the company expects to make 100 million doses available — all of which have been purchased by the federal government.
During the discussions of the Johnson & Johnson clinical trial by the CDC’s advisory committee, some reservations were expressed over the fact that the vaccine appeared to be “less effective among people aged 60 and older with certain medical conditions such as diabetes and hypertension.” Efficacy among American Indian and Alaska natives was also lower than in the overall study. While there are clearly differences among the three vaccines, Dr. Jason Goldman, a representative of the American College of Physicians and a liaison to the CDC’s advisory committee, said, “We want to make sure the public understands the best vaccine is the one they can get access to.”
Many struggle with vaccination scheduling systems
Joanna Stern, a columnist for the Wall Street Journal, put it this way: “Congrats! You survived 12 months of pandemic! Now fragmented systems, shoddy websites and limited vaccine supply stand in the way of you and, well, the rest of your life.” Oh, how true. My own experience in helping an older, and not very tech savvy, family member attempt to get a vaccine appointment at the nearby chain pharmacy was nothing short of an exercise in futility — and frustration — not to mention lack of success. As I struggled with the process, I began to realize that this is not a task for the faint of heart or for someone who isn’t used to navigating the online equivalent of a corn maze.
So, I immediately glommed on to Ms. Stern’s latest article with tips on how to succeed in the process. Following are her recommendations that you can pass along to patients, clients, family members, and friends. Hint: Agreeing to help isn’t a bad idea either, as some of this might be a bit foreign to that 80–year-old you’re trying to assist.
Step 1: Find social media groups, like those on Facebook, to help with appointment bookings. Because most of the vaccine availability is local, this is a good way to investigate options — but with care. Seniors, especially, should be reminded about not sharing critical personal information such as a Social Security Number. For the most part, all that is needed is the person’s name, date of birth, address (or zip code), phone number, and email address.
There are many sites that have been designed to help with the process. This one from AARP has information for all 50 states as does another from COVID-19 Vaccine Spotter that tracks chains and vaccine availability by state.
Step 2: Learn how to navigate the appointment website(s) and bookmark them when you finally get there as many are, for lack of a better term, buried.
CVS has a vaccine screening tool that will establish eligibility and, once that is determined, it leads to another page where a zip code will lead the user to yet another, longer form to be filled out. The advice is to select “Don’t Know” to answers that require more thought to get through the questionnaire and to the appointment schedule more quickly. CVS’s appointment availability appears to generate around 6 a.m. EST each day.
Rite Aid also has an online tool that requires personal information, then the user can scroll through a list of stores where vaccines are available.
Walgreens has a vaccine availability checker and requires that the user have an account to book an appointment. The Walgreens site also has an option to remain logged in and, if all else fails, the company accepts phone calls to book appointments.
Step 3: Take advantage of autofill features that will drop required information into an onsite form quickly. This helps when you have “50,000 people vying for one cancellation spot” (yes, seriously).
Step 4: Use browser extensions like Page Refresh to stay up to date on sites and available appointments, since they tend to disappear only minutes after becoming available. One caution, though – stop the refresher once an open appointment comes up so that a screen refresh does not take place in the middle of entering information to snag an appointment.
Step 5: Book an appointment. The vaccine is generally free so insurance information should not be required. If insurance information is needed, it can be presented at the time of the appointment which will save time in the booking process.
Strap on your patience before you start — you’ll probably need it!
New leadership at HHS and CMS
About a week ago, confirmation hearings took place for President Biden’s nominee for Secretary of the Department of Health and Human Services (HSS). A former member of Congress and California Attorney General, Xavier Becerra, would be the first Latinx person to serve as Secretary of HHS. According to the article published by the National Association for Home Care & Hospice (NAHC), Senator Susan Collins (R-ME) asked the nominee about more money for struggling healthcare providers as she was “astonished that in a $1.9 trillion COVID-19 package, the administration did not include any money for a provider relief fund.” Becerra responded by saying that the administration “will be there to provide the support” but without necessarily committing to more provider relief funding. Notably, Senator Collins and Senator Joe Manchin (D-VA) have asked for another $35 billion in provider relief.
The importance of rural health was also a topic of questioning, with Becerra indicating that rural communities do face their own unique challenges associated with access to care.
According to NAHC President Bill Dombi, “Secretary-designee Becerra made it clear in his hearing that, if confirmed, he will be certain to support improvements in access to home and community–based services. This is especially crucial as the growing population of individuals of advanced age find a need for care that extends beyond the capabilities of the current health care system. We look forward to working with the Department of Health and Human Services to secure patient-centered health care in the care setting of choice; one’s own home.”
While the Secretary’s nomination is pending, the administration has also nominated Chiquita Brooks-LaSure to be the next Administrator of the Centers for Medicare & Medicaid Services (CMS). She is no stranger to CMS, where she led work on implementation of the Affordable Care Act during the Obama administration. Currently, Brooks-LaSure is the Managing Director of Manatt Health and serves as a member of several organizations devoted to improving access to care.
Compliance
CMS clarifies intent of CARES Act regulatory changes for home health
In the February edition of the COVID-19 Briefing, we addressed three questions arising from contradictions between Medicare manuals and the Code of Federal Regulations concerning Face–to–Face Encounters (F2F). On March 1, NAHC provided an update to its original reporting. Here’s what you need to know:
The first question was related to the inconsistency between the May 8, 2020 changes to the regulations regarding who can perform the F2F and the updated guidance found in Chapter 7 of the Medicare Benefit Policy Manual. The essence of the issue is that the plain text of the updated regulation suggests that when the patient is starting care based on a community (physician or allowed practitioner) referral, the expectation is that the same person will conduct the F2F and provide the certification of eligibility as generally found in the plan of care. In short, the same person must perform the F2F and sign the plan of care. Of course, this new limitation has the opposite effect of elasticizing the requirements that were in place prior to the changes imposed by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. More to the point, despite the change in the language of the regulation, the provisions in Chapter 7 related to who can perform the F2F did not change, with the end result being a contradiction between the regulation and interpretive guidance. CMS initially expressed its intent that the flexibility that would enable an allowed practitioner to conduct the F2F was not meant to be eliminated.
According to NAHC, all three of the home health Medicare Administrative Contractors (MACs) – Palmetto GBA, CGS, and National Government Services – will “follow the manual instructions in the Medicare Benefit Policy Manual, Chapter 7, at Section 30.5.1.1.” This means that even though there is a contradiction, at present, CMS intends to a) fix it and b) continue with what has been in place previously with respect to who can perform a F2F. NAHC’s recommendation is that agencies follow the manual rather than the regulation itself until such time that CMS revises the regulations to conform to the instructions in the manual.
The second question was whether the regulatory changes were intended to expand allowed practitioners’ ability to order private duty nursing services under Medicaid. CMS has clarified that the statutory changes relate only to home health services, including those covered by Medicaid, and do not extend to other private duty coverage rules.
NAHC raised a third question for CMS related to additional incongruities among various Medicare manuals – including Chapter 7 of the Medicare Benefit Policy Manual and Chapter 4 of the Medicare General Information, Eligibility and Entitlement Manual. CMS’s response is as follows:
We note that Chapter 7 of the [Medicare] Benefit Policy Manual does include erroneous language regarding who may sign the POC. We do plan on correcting this language as soon as possible, as well as updating the language in Chapter 4 of the Medicare General Information, Eligibility and entitlement manual.
In the meantime, you can refer providers to the FAQs found in the program guidance and information on the CMS.gov website about our response to COVID-19. We state that the home health conditions of participation do not prohibit home health agencies (HHAs) from accepting orders from multiple physicians, and now with the recent statutory change nurse practitioners, physician assistants, and clinical nurse specialists (i.e. allowed practitioners). The HHA is ultimately responsible for the plan of care, which includes assuring communication with all physicians and allowed practitioners involved in the plan of care and integrating orders from all physicians/allowed non-physician practitioners involved in the plan to assure the coordination of all services and interventions provided to the patient. This responsibility extends to a physician or other allowed non-physician practitioner, other than the certifying physician or allowed non-physician practitioner who established the home health plan of care who signs the plan of care or the recertification statement in the absence of the certifying physician or allowed non-physician practitioner. This is only permitted when such physician or non-physician practitioner has been authorized to care for his/her patients in his/her absence. The HHA is responsible for ensuring that the physician or allowed non-physician practitioner who signs the plan of care and recertification statement was authorized by the physician or allowed non-physician practitioner who established the plan of care and completed the certification for his/her patient in his/her absence. Our regulations at 42 CFR 424.22(a)(1)(v)(A) require that the physician or allowed practitioner that performed the required face to face encounter also sign the certification of eligibility unless the patient is directly admitted to home health care from an acute or post-acute care facility and the encounter was performed by a physician or allowed practitioner in such setting.
Please note that this does not limit who may sign the POC to practitioners in the same group practice. This FAQ can be found at https://www.cms.gov/files/document/030920-covid-19-faqs-508.pdf.
Medical necessity and documentation requirements added to hospice recovery audit topics
Performant, the Recovery Audit Contractor for home health and hospice, has added a hospice issue to its list of approved audit topics. Issue 0201 will focus on Hospice Continuous Home Care for audit of medical necessity and documentation requirements. Claims that do not meet the requirements for demonstration of medical necessity and documentation of services will be denied. We will report in more detail on this in a future resource, but hospice teams should be aware of the potential for audit. For the moment, hospices should remember the following:
- Continuous Home Care (CHC) is to be provided only during periods of crisis to maintain a hospice patient at home. CHC cannot be provided in an inpatient facility including a skilled nursing facility (SNF), a hospice inpatient unit, or a hospital.
- A minimum of eight hours per day of nursing and aide care must be provided during each 24-hour period. The care need not be continuous, but it must total eight hours and must be predominately nursing care.
- The patient’s plan of care must be modified to take CHC into account and documentation must clearly establish the delivery of skilled services to the patient throughout each 24-hour period for the time(s) that the nurse is present. CHC documentation is often the Achilles heel of hospice providers. To be forewarned is to be forearmed.
Comprehensive error-rate testing
Along with its restitution of medical review last August, CMS also again activated CERT program audits. Documentation requests have started arriving for review of claim submissions during the 2020 and 2021 reporting years, which includes periods from July 2019 through June 2021. As NAHC recently reported, these periods will include claims that could be affected by public health emergency waivers and flexibilities with specific emphasis on hospice claims and supporting elections from October 2020 forward. Like Additional Documentation Requests (ADRs) issued by other Medicare contractors, CERT requests should be responded to within 45 calendar days of the request.
New OIG work plans put home health in the spotlight
The HHS Office of the Inspector General (OIG) announced two new home health work plans in mid-January.
“Home Health Agencies’ Challenges and Strategies in Responding to the COVID-19 Pandemic” will address how agencies have been able to meet the challenges of procuring necessary equipment and supplies, implementing telehealth, and addressing staffing shortages. The nationwide study of agencies will provide insights into the strategies home health agencies have used to address COVID-19, including how well their emergency preparedness plans have served them.
The second addition to the work plan, as covered in our most recent Home Health & Hospice Compliance Alert, addresses the use of telehealth during the public health emergency. The “Audit of Home Health Services Provided as Telehealth During the COVID-19 Public Health Emergency” will measure how services have evolved and which types of services have been furnished through telehealth, and whether those services were administered and [not] billed in accordance with Medicare requirements. Overpayments will be reported, and recommendations will be made to CMS based on the study.
Clinical
Counterfeit PPE: 3M to assist providers in authenticating N95 masks
The 3M company recently released new guidance to assist providers in identifying fraudulent N95s. Early in the public health emergency, the company committed to increased production of N95 masks and, despite quadrupling production, is still not keeping up with demand. Even with increased production, counterfeit masks remain on the market. The company has also been working to take aggressive legal action against price gouging and counterfeit products which have not been tested and are not approved by the National Institute for Occupational Safety and Health (NIOSH).
3M recommends that its products be purchased only from authorized distributors. Providers with respirators bearing a 3M brand can contact the company for a list of authorized distributors and/or product authentication by either calling the hotline number at 1-800-426-8688 or establishing a request for information through the website.
FDA issues warning on pulse oximeter accuracy
The public health emergency has caused an uptick in the use of pulse oximeters among the general public. However, new reports suggest that the devices may be less accurate for people with dark skin. The FDA “is informing patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels” the devices have limitations, and the “risk of inaccuracy” should be considered. The devices are least accurate when readings suggest an oxygen saturation level of less than 80%. Moreover, providers should use pulse oximeter readings as an estimate of oxygen saturation levels — for example, a reading of 90% may signify an actual saturation level of somewhere between 86% and 94%.
Prescription devices, which receive FDA review and approval, are generally more accurate. Devices sold over the counter (OTC), including those with smart phone apps, are not intended for medical purposes and have not been cleared by the FDA. Patients who are using OTC devices should be aware of their potential shortcomings.
Patients should be educated that many factors can affect the accuracy of readings including poor circulation, skin pigmentation, skin thickness, skin temperature, tobacco use, and presence of fingernail polish. Patients should be advised to:
- Follow manufacturer’s instructions.
- Place the device on warm, relaxed fingers held below the level of the heart and preferably on fingers that do not have nail polish.
- Patients should sit still and wait a few seconds before the reading stops with display of a steady number to identify their oxygen level.
- Signs and symptoms of oxygen deprivation should take precedence including bluish tinges to one’s face, lips, or nails; shortness of breath or difficulty breathing; restlessness or discomfort; chest pain or tightness; and/or a fast or racing pulse.
The FDA notice can be found here.
Administrative
How to bill for the COVID-19 vaccine
The March Medicare Bulletin has some good reminders for those who are billing for vaccine administration and monoclonal antibody infusions. Additional information can be found on the CMS Billing for COVID-19 Vaccine Shot Administration page. Here is a summary of what providers need to know:
- When vaccine doses are provided by the government without charge, the vaccine administration is the only thing that can be billed. Vaccine codes should not be included on claims.
- For patients enrolled in Medicare Advantage plans, the claims should be submitted to original Medicare.
- The bill type codes will be as follows:
- SNF – 23S
- Home Health – 34X
- Hospice – 81X or 82X
- Condition Codes include:
- A6 – 100% payment
- 78 – New coverage for MA patients
- 90 – When services are provided as part of an Expanded Access approval
- 91 – When services are provided as part of an Emergency Use Authorization
- Revenue Codes
- 0771 for Preventive care services – vaccine administration
- 0636 – pharmacy, drugs requiring detailed coding
- HCPCS Codes will not be reported if the vaccine is received for free
- Diagnosis Codes
- Z23 – encounter for immunization
- U071 – COVID-19 monoclonal antibody infusion
In closing
Another month of the public health emergency has gone by. There are, no doubt, several more to come. But, little by little, I can see that things are getting better and there is renewed hope for better days ahead. The snow is melting, the sun is out, and the birds are coming back to the place I call home and “the frozen north.” It has been a long haul — especially for those who care for patients every day. And so, as I sign off this month, it is with a familiar refrain. Thank you for always being there for your patients and their families. Thank you for caring. I am very proud to be part of your community and to contribute in the small ways that I can. Be well and be safe.