CMS clarifies implications of new regulations: Your COVID-19 Briefing
In this edition
Use the links listed below to jump between sections.
NEWS
COMPLIANCE
CLINICAL
FDA issues alert on imports of hand sanitizers
Vaccine developments
New from the WHO: COVID-19 vaccinations during pregnancy
COVID-19 and new onset diabetes
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
January came and went, bringing with it plenty of snow. Now as February begins, I am reminded that, as of next month, the public health emergency will be a year old. The news around COVID-19 is not as overwhelming as it once was (thank goodness), but there is still plenty to know. There are new vaccines on the horizon, including one from Johnson & Johnson, which announced that it will seek emergency authorization from the U.S. Food and Drug Administration (FDA) to distribute its vaccines. Schools in many places are beginning to reopen, and high school and college sports are resuming in many states. For those of us who have traveled to industry conferences in the past, there are even actual, in-person summer conferences on the schedule. Even so, the new administration in Washington, D.C. has announced that the public health emergency will “likely” go on through the entirety of 2021, and if the Secretary of Health and Human Services (HHS) moves to curtail it, we will be given at least 60 days of advance notice.
The United States has now passed 26.2 million COVID-19 infections. The good news? That represents a 32% decline in new infections over the prior two weeks. Likewise, mortalities are also decreasing, although at a slower rate. Currently, more than 442,000 people in the U.S. have died from COVID-19. With new variants from Britain, Brazil, and South Africa, predictions suggest that the mortality count will be somewhere between 479,000 and 514,000 by mid-to-late February. Thankfully, hospitalizations in most areas have also declined and are now below 100,000. I am optimistic about a continuation of that trend.
The heat map from the New York Times isn’t quite as red as it was last month — another good sign — but we are still seeing more hot spots in the West and South than in other places. We are almost at the 30th iteration of this briefing, and one thing stands out — the virus seems to travel in cycles.
The New York Times also released a new set of maps, developed in conjunction with the Johns Hopkins Bloomberg School of Public Health and Resolve to Save Lives (an initiative of Vital Strategies). The maps show the changes in overall infection risk across counties in the United States between last September and the end of January. From the hue, one can surmise that things got a lot worse between September and December, and now, things are getting better — even though we aren’t out of the woods just yet.
The key to the categories of risk is as follows:
- Counties that are at extremely high risk are those with more than 640 COVID-19 cases per 100,000 people in the last two weeks. Counties with positive test result rates of more than 10% also fall into this group.
- Counties at very high risk have more than 160 cases per 100,000 (but fewer than 640).
- High risk counties reported more than 40 cases per 100,000 people
- Medium risk areas have 10 cases per 100,000 persons.
- Low risk areas have fewer than 10 cases per 100,000 people.
To see details for your county, visit the interactive maps at the New York Times website.
The Wall Street Journal map of daily case reports shows the drop in new cases over the last two weeks.
We know that mortalities always lag fluctuations in new case counts, and the graph below from the New York Times tells the story. We can expect to see the trend decline in the coming weeks as new reported cases decline.
To round out the statistics, the following graph, also from the New York Times, shows the downward trend in hospitalizations.
Nursing homes continue to be in the news with respect to the virus. Cases have been reported in more than 30,000 facilities and have affected more than 1.2 million residents and employees. More than 148,000 people affiliated with nursing homes have perished which adds up to about 30% of all deaths from the virus in the U.S. In 12 states, the death toll for nursing home residents amounts to more than 50% of the COVID-19 mortalities for the entire state.
But there is some good news for nursing homes. The Centers for Medicare & Medicaid Services (CMS) announced that the week ending January 17 marked the fourth straight week of declines in nursing home infections. Case counts dropped from 32,000 to fewer than 18,000 that week — suggesting that the push to vaccinate nursing home residents is yielding results. About 3.1 million vaccine injections have been administered at long-term care (LTC) facilities, which includes assisted living facilities. That includes about 2.7 million initial doses and under 400,000 second doses. There have been high levels of participation among residents — however, the CDC reports that only about 38% of nursing home workers have received their first dose.
Not surprisingly, many reports from nursing home operators across the country suggest that the congressional arguments concerning liability shields are taking a far distant second place, compared to concerns about declining occupancy rates as many patients bypass nursing home care in favor of receiving care at home.
While the news last year throughout the fall was focused on testing, the latest news is squarely focused on the vaccine rollout. States differ in their approaches to vaccinations in terms of which groups are eligible and when they can be vaccinated. We are learning that the bulk of the vaccination effort is shifting away from hospitals that are already overwhelmed with patients and staff shortages and toward retail pharmacies — especially for new vaccines that have less stringent storage requirements. The New York Times map below shows the share of the population in each state that had been vaccinated by the end of January. About 31 million vaccinations have been performed, and doses have ramped up to about 1.3 million per day as of this writing. The Biden Administration expects to have at least 100 million people vaccinated in its first 100 days.
For professionals caring for elderly patients, the following map will also be of interest, because it depicts each state’s rules for vaccinating seniors and how they differ. States in the darkest purple are those where residents who are at least 65 years old are now eligible for vaccination in addition to frontline workers. For agencies that are fielding questions from patients and their caregivers about vaccine availability, the Wall Street Journal has published a state-by-state list of resources. You can see the full list from WSJ here.
News
New CDC guidance for public transportation
On January 29, the Centers for Disease Control and Prevention (CDC) updated their guidance concerning the use of masks with a mandate that becomes effective at midnight, February 1. The order is 11 pages long, and you can read it here. The following is the essence of the order as it currently stands:
- Operators of public conveyances must require persons onboard to wear masks during the boarding process, for the duration of travel, and while disembarking. This includes a mandate to wear a mask while in a transportation hub, such as an airport or train station. The order extends to any form of public transportation including airplanes, ships, ferries, trains, subways, buses, taxis, and ride shares.
- Masks must cover the person’s mouth and nose and should be made of a solid piece of material without slits, exhalation valves, or punctures.
- Cloth masks should be made with two or more layers of a breathable fabric that is tightly woven and which does not let light through when held up to a light source.
- Masks should be secured with ties, ear loops, or elastic bands that go behind the head. If gaiters are worn, they should have two layers of fabric. Alternatively, they can be folded to make two layers.
- Masks should fit snugly against the side of the person’s face.
Masks can be either manufactured or homemade and can be reusable or disposable. This includes N95 masks. They can have inner pockets. Clear masks or cloth masks with a clear plastic panel can be used to facilitate communication with those who are hearing impaired or others who need to see a speaker’s mouth to understand speech.
The following do not fulfill the requirements of the CDC order:
- Masks worn in a way that does not cover the person’s mouth and nose.
- Face shields or goggles worn alone.
- Scarves, ski masks, balaclavas, or bandanas.
- Shirt or sweater collars such as turtlenecks pulled up to cover the person’s mouth and nose.
- Masks made of loosely woven fabric or that are knitted. If light can pass through it, the mask is not acceptable.
- Masks made from materials that are hard to breathe through including vinyl, plastic, and leather.
- Masks with slits, exhalation valves, or punctures.
- Masks that do not fit properly meaning that they have gaps, are too loose, or too tight.
The CDC’s guidance related to the mask mandate goes on to suggest that people are not required to use a mask under certain conditions, including:
- When eating, drinking, or taking medications for brief periods of time.
- While communicating, for brief periods of time, with a person who is hearing impaired when the ability to see the speaker’s mouth is essential for communication.
- While wearing an oxygen mask on an airplane that has lost cabin pressure.
- During periods of unconsciousness (not including sleeping), incapacitation, or when unable to remove the mask without assistance.
- When it becomes necessary to remove the mask to verify the person’s identity — for example, at the airport for screening by the Transportation Security Administration.
Children under the age of two are exempt from the requirements as are those with a disability who cannot safely wear a mask for reasons that relate to the disability. Those for whom wearing a mask would create workplace health or safety risk are also exempt from the requirements.
Finally, while the mandate applies to public conveyances, it does not apply to private conveyances that are operated for non-commercial purposes. The mandate also does not pertain to commercial vehicles when the driver is the only person in the vehicle.
2021 special enrollment period for health insurance
By executive order, the President announced a special enrollment period for individuals and families to avail themselves of health insurance coverage through the affordable care marketplace at HealthCare.gov. Noting that many have lost insurance coverage and have also experienced new health challenges during the pandemic, the enrollment period will allow people who reside in states with marketplaces served by the HealthCare.gov website to enroll in coverage from February 15 through May 15. The expanded enrollment period will help those who are submitting new coverage applications or who wish to update an existing application. State-based marketplaces (SBMs) will be able to take similar actions within their states. The executive order as well as the corresponding press release and fact sheet can be found at the following sites:
Executive order: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/executive-order-on-strengthening-medicaid-and-the-affordable-care-act/
Press release: https://www.hhs.gov/about/news/2021/01/28/hhs-announces-marketplace-special-enrollment-period-for-covid-19-public-health-emergency.html
Fact sheet: https://www.cms.gov/newsroom/fact-sheets/2021-special-enrollment-period-response-covid-19-emergency
Compliance
CMS response to home health questions arising from the CARES Act
On January 29, the National Association for Home Care and Hospice (NAHC) published CMS responses to several outstanding questions emanating from new regulations. Following are the questions (paraphrased) and the answers that were provided.
Question 1 — Face-to-face (F2F) encounter changes:
There is confusion among home health providers concerning changes in the regulations at 42 CFR §424.22(a)(v)(A)(2) and §424.22(a)(v)(C)(1) and (2).
The first cited section of the regulation indicates that a nurse practitioner (NP), physician assistant (PA), or certified nurse specialist (CNS) may conduct a face-to-face encounter when collaborating with a certifying physician whether in a facility or in the community.
The second cited section of the regulations limits who may conduct the encounter when an allowed practitioner such as an NP, PA, or CNS is certifying the patient’s eligibility for home health services through a community referral. In fact, §424.22(a)(v)(C) reads as though the NP, PA, or CNS may only conduct the encounter if they are also the certifying practitioner.
The two sections of the regulations, as rewritten in 2020, are in conflict and seem to prohibit non-physician practitioners (NPPs) who are not certifying eligibility but who are working in collaboration with a certifying physician to conduce the encounter in connection with the home health admission.
CMS Response: The statute states only that the certifying physician must document that the physician or non-physician practitioner has had a face-to-face encounter prior to certification. It does not prevent a community-based physician from conducting the F2F, when he/she is not the certifying physician. Therefore, this would not limit the F2F (conducted by a community physician or allowed NPP) to only the certifying physician or allowed practitioner. We will consider proposing conforming regulation text changes in future rulemaking to make this clear.
NAHC is seeking clarification on whether the Medicare Administrative Contractors (MACs), and presumably other Medicare contractors conducting medical reviews, have received instructions regarding CMS’s position related to the changes in the statute. While that answer is pending, I would advise keeping it within the text of the regulations just to be on the safe side, if possible. That means:
- If the patient is coming from a facility stay, the face-to-face encounter can be performed by an NP, CNS, PA, or nurse midwife working in collaboration with the facility physician or the facility physician themself. The physician or allowed practitioner who signs the plan of care can certify the encounter on that basis and needs only to provide the date of the encounter in connection with their certification.
- If the patient is not coming from a facility stay and is being referred by a physician or allowed practitioner who intends to also provide the plan of care, the encounter should be performed by that individual themself or a nurse midwife working in collaboration with the certifying physician.
If the agency can obtain the face-to-face encounter documentation as outlined directly above, there will be no potential for argument in medical review. If it cannot, until the text of the regulations is changed, there will be the potential for argument over what is required by the regulations versus what was intended by CMS at the time that the regulation was drafted.
Question 2 – Which practitioners are allowed to order private duty nursing services?
[NAHC assumes] that 42 CFR §440.80 regarding private duty nursing under Medicaid was not changed to reflect non-physician practitioners ordering services since the Coronavirus Aid, Relief, and Economic Security (CARES) Act provisions were specific to home health. [NAHC is] receiving questions from members and wants to be sure that is the case rather than an oversight.
CMS Response: The changes enabling allowed practitioners to certify and order services were made under Medicaid HH as well; however, we cannot speak to private duty nursing under Medicaid. Please reach out to MMCO for advisement regarding this question.
NAHC has reached out to the Medicare and Medicaid Coordination Office (MMCO) for clarification.
Question 3 — Home infusion therapy supplier rules and hospice
Clarification is needed on the intersection between the new home infusion therapy (HIT) supplier benefit and beneficiaries receiving hospice care. [NAHC] understands that the professional services related to Part B infusion drugs are carved out of the home health benefit beginning January 1, 2021. There is confusion, however, regarding whether hospice providers are required to provide the professional services related to a Part B infusion drug under the hospice benefit billed under Part A, or must a HIT supplier provide those services under Part B. The need for the drug in this case would be related to the terminal illness, for example, a morphine infusion for pain.
CMS Response: The 21st Century Cures Act only excluded home infusion therapy services from home health services. All infusion services related to the hospice patient’s terminal illness and related conditions would remain covered under the Medicare hospice benefit.
OIG workplan for home health
The HHS Office of the Inspector General (OIG) has two new workplans focused on home health services during the public health emergency:
- The first is an evaluation of home health services that were provided via telehealth or other remote means during the public health emergency and whether those services were administered in accordance with Medicare requirements. Of course, telehealth services are not billable services, but part of the workplan is to investigate whether such services were, in fact, erroneously billed in which case the OIG will report on overpayments and improper billings for services. Many predicted that this initiative would be coming in early 2020 so the announcement comes as no surprise. The report is expected in 2021.
- The second project is focused on home health agencies’ challenges and strategies in responding to the pandemic and how agencies obtained supplies, addressed staffing shortages, and implemented remote services to treat patients in their homes. This is a nationwide study to provide insight into how home health providers have operated during the public health emergency. The report is expected in 2022.
Clinical
FDA issues alert on imports of hand sanitizers
Last week, the FDA issued an import alert that will allow federal authorities to detain shipments of hand sanitizers coming from Mexico due to safety concerns. This is a first-of-its-kind alert that comes after other warnings going back to early 2020 that found that more than 80% of hand sanitizer samples tested from Mexican manufacturers were not in compliance with FDA requirements. More than half of the samples contained methanol or 1-propanol, both of which are toxic substances.
If the agency or any of its patients may have acquired these products, dispose of them as hazardous waste. In the meantime, here are the symptoms to watch for based on CDC guidance.
Early adverse effects:
- Headache
- Blurred vision
- Nausea and/or vomiting
- Abdominal pain
- Drowsiness
- Decreased consciousness
- Ataxia (inability to coordinate muscle movements)
Severe effects can include:
- Blindness
- Seizures
- Metabolic acidosis
- Death
There are now more than 200 products from 50 manufacturers located in Mexico, China, Turkey, Korea, Guatemala, and six U.S. states that have been found to contain toxic chemicals.
Vaccine developments
As I mentioned earlier, the focus seems to have shifted away from testing in favor of vaccination rates in each state. But what about the differences among the vaccines? Which one is best and exactly how should we be thinking about their overall effectiveness?
There are five vaccines, two of which already have FDA emergency authorization — the Pfizer BioNTech vaccine and its counterpart offered by Moderna. Both are what is known as messenger RNA (mRNA) vaccines that rely on immune memory that mimics exposure to a virus. The AstraZeneca vaccine, which is now approved for use in Europe, relies on an adenovirus which is a weakened form of the virus. The same is true of the Johnson & Johnson vaccine for which FDA approval will be sought in February. The Novavax vaccine, which also comes from Europe, is a protein subunit vaccine, which means that it uses a laboratory–made version of the virus’s spike protein. It is not approved for use in the U.S.
The vaccines have been carefully tested on thousands of people and by now have been received by millions. While there were varying levels of overall effectiveness between the various versions, all the approved vaccines have gone through rigorous studies to ensure that they are safe. Both the FDA and the CDC are continuously monitoring for any problems and side effects. Not only is a vaccinated person much less likely to contract COVID-19, but studies show that the vaccine may also reduce the likelihood of severe disease even if you do get COVID-19.
South Africa is experiencing some of the strongest new variants of the virus. It is noteworthy that both of the two most recent vaccine candidates have reported results from South Africa — Novavax at 60% efficacy and Johnson & Johnson at 57% efficacy. These efficacy rates were lower than those in the US and UK due to the new variants in South Africa, which represented 95% of the COVID-19 cases in the trial.
The key question is which vaccine should we get? The answer, according to most experts, is whichever one you can get first. It is entirely possible that many people will not have much choice because of supply versus demand and, for those not close to a facility with sub-zero storage capacity, a more limited array of available options. Here is some background information on the vaccines:
- Both the Pfizer BioNTech and Moderna vaccines require two doses a few weeks apart. The Johnson & Johnson vaccine is given in a single dose.
- Only the Pfizer BioNTech vaccine was tested in children under 18. The Moderna vaccine is cleared for those 18 and older because there were no people younger than 18 in the clinical trial.
- The Pfizer BioNTech and Moderna vaccines had a higher efficacy rate — about 95% — than the Johnson & Johnson vaccine. However, neither were tested when any of the three variants, which are now circulating, were known.
- The Johnson & Johnson trial was more recent and did encounter the South African variant, against which it was not as effective as it was against variants in the US and UK. Nonetheless, 28 days after vaccination, the Johnson & Johnson vaccine was found to be 85% effective at preventing severe disease across all the regions studied. The vaccine’s efficacy against severe disease actually increased over time with no cases in vaccinated participants reported after day 49. By comparison, the annual flu shot is considered to be highly effective at 60% prevention of severe illness. Read more details about the Johnson & Johnson vaccine study here.
It is the new administration’s goal to vaccinate 100 million people — a third of the population — within its first 100 days. It’s a tall order, but I’m hoping we can get it done.
New from the WHO: COVID-19 vaccinations during pregnancy
The World Health Organization (WHO) recently changed its language concerning COVID-19 vaccinations during pregnancy by essentially dropping its previous warnings advising against the use of Moderna’s vaccine in pregnant women.
The new language says that “while pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy. Nevertheless, based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women. For this reason, those pregnant women at high risk of exposure to SARS-CoV-2 (for example health workers) or who have comorbidities which add to their risk of severe disease, may be vaccinated in consultation with their health care provider.”
This is a change from the language offered in January that suggested that the use of the vaccine was “currently not recommended” unless the woman was at high risk for exposure as would be the case for a health worker. The language change is intended to create more clarity and extends to both the Pfizer BioNTech vaccine and the Moderna vaccine.
Notably, the new language from WHO corresponds more closely to what the CDC recommends, which is that pregnant women may be vaccinated if they wish and that a conversation with the patient’s clinical team is advised. The American College of Obstetricians and Gynecologists also supports the availability of vaccines for pregnant women.
COVID-19 and new onset diabetes
Just as I sat down to write, the Washington Post published a new article about a potential link between diabetes and COVID-19. Here are some of the highlights.
- Although COVID-19 often affects the patient’s lungs, it is also increasingly associated with a range of other problems — including blood clots, neurological disorders, and kidney and cardiac damage. It appears as though new-onset diabetes among COVID-19 patients may be the next condition to be added to the list of complicating conditions, and that includes both Type 1 and Type 2 diabetes.
- Many who develop new diabetes following COVID-19 have clear risk factors, such as obesity or a family history of diabetes. High blood glucose levels are common among those who take dexamethasone which is a steroid used to treat COVID-19. Cases are also being seen in patients with no known risk factors and in some instances, the diabetes is showing up long after the patient’s body has cleared the virus.
- It is estimated that just under 15% of people hospitalized for treatment of severe COVID-19 developed new onset diabetes.
- Concerns that COVID-19 might be directly implicated with the onset of diabetes were supported by the exceptionally high doses of insulin that some diabetes patients required while hospitalized for treatment of COVID-19. There is some speculation that this may even be a new hybrid form of diabetes “that might play out differently from the traditional forms of the disease.”
- It is not clear whether patients who contract diabetes during or just after COVID-19 will have the condition for a short period of time or for the rest of their lives.
- One of the things that investigators are looking into is whether ACE2 receptor cells, which are the virus’s entryway into the body, could provide answers to some of the lingering and new research questions. According to the article, “when the spike proteins that surround the virus latch onto a host cell with an ACE2 receptor, they open up a cellular doorway that allows the virus to hijack the cell. Strong evidence of ACE2 receptors on beta cells could confirm long standing suspicion that viruses trigger diabetes,” although, at present, research on the subject is inconclusive.
There will be more to come on this topic, given that diabetes is one of the most common chronic illnesses among the elderly in particular, and now a potential parting “gift” of sorts from COVID-19. It’s a fascinating read.
Administrative
Paycheck Protection Program update
Shortly after our last edition of the COVID-19 Briefing, the Small Business Administration (SBA) updated its website related to Paycheck Protection Program (PPP) loans. Here is what we now know about the second round of PPP availability.
- The Omnibus Appropriations and Coronavirus Relief Package set aside an additional $25 billion for PPP loans for eligible borrowers who are generally small businesses with up to 10 employees or businesses with no more than 300 employees operating in low to moderate income areas.
- Loans for borrowers serving low to moderate income areas can be in amounts up to $250,000.
- The Second Draw loans will generally have the same loan terms as original draws (even if the lender changes) and can be used to fund payroll and benefits costs, mortgage interest, rent, utilities, worker protection expenses related to COVID-19 (such as for PPE), uninsured property damage costs caused by looting or vandalism during 2020, certain supplier costs, and expenses for operations.
- For most borrowers, the maximum loan amount for a Second Draw is 2.5 times the average monthly 2019 or 2020 payroll costs up to a maximum of $2 million.
In order to be eligible, Second Draw borrowers must have used their first PPP loan only for authorized purposes and have no more than 300 employees. The borrower must also be able to demonstrate at least a 25% reduction in gross receipts between comparable quarters in 2019 and 2020.
The SBA site was opened for submission of applications on January 13, and the site will remain open through March 31.
Department of Labor issues new COVID-19 workplace guidance
The United States Department of Labor (DOL) issued new Occupational Safety and Health Administration (OSHA) worker safety guidance designed to assist employers with implementing a coronavirus protection program for workers and identifying exposure risks.
The new guidance, titled Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace, offers new planning guidance along with discussion of existing safety standards that are intended to bolster safe working environments. Importantly, the new guidance is just that — a recommendation, and not a regulatory standard. It creates no new legal obligations for employers meaning that the recommendations are “advisory in nature, intended to assist employers in recognizing and abating hazards likely to cause death or serious physical harm as part of their obligation to provide a safe and healthful workplace.”
The guidance suggests that employers engage in five activities as part of a prevention program by:
- Conducting a hazard assessment.
- Identifying measures that will limit the spread of COVID-19.
- Adopting measures to ensure that employees who are infected or potentially infected are sent home.
- Ensuring that protections from retaliation are implemented to protect workers who raise COVID-19–related concerns.
- Ensuring that policies and procedures related to worker protection are communicated effectively for both English-speaking and non-English speaking employees.
The guidance is lengthy and addresses what workers need to know about COVID-19 in the workplace, the roles of employers and employees in responding to COVID-19, and details about key measures that can be taken to limit the spread of the virus at work.
In closing
It seems like the pandemic and public health emergency have been going on forever. The extension of the public health emergency for the remainder of 2021 portends both good and not-so-good things for us. Good things for providers who need to continue taking advantage of flexibilities offered by the §1135 waivers, and not such good things for all who want the public health emergency to be over and well behind us. But, as my grandmother used to frequently tell me, “if wishes were horses, we all would ride.” I’ve more or less resigned myself to rolling with the punches for the near term and hoping for a return to something that begins to approach what used to be normal sometime in the not-too-distant future. In the meantime, like you, I’m hanging in there with one main thing in mind as I look out at the 4-foot snowdrift at the end of my driveway: spring is only 48 days away and after it gets here, I can probably handle just about anything. Be safe out there, be well, and take care. I’ll be back with more next month.