It has been 25-28 days since local and State-wide Orders to Stay at Home was issued, and there are early signs that this (combined with related activities: many essential staff working from home, physical distancing, wearing facial coverings in public) have slowed the rate of new case identification, deaths, hospitalizations, and ICU bed utilization. It is too soon to ease up on vigorous public health measures, but this trend, combined with analysis of current bed capacity suggests that the peak number of cases for this first wave of COVID-19 in our region may not stress our health care delivery system as severely as we were concerned about earlier. The price of this apparent success is a large non-immune (and therefore susceptible to COVID) population which can lead to rapid focal outbreaks as public health measures are eased. Yesterday Governor Newsom described the outline of how this delicate task might unfold.
A major task for outpatient providers will be to establish trust in the population that they can safely come in to the office for important medical, dental, vision, lab, radiology and physical therapy visits (that cannot adequately be done via video visits), even while many public health restrictions remain in place. To be successful, practices will need to pair careful adherence to rigorous infection control procedures with a positive yet nuanced marketing campaign.
Here is a summary of major updates from PHC, the state and the medical word related to COVID-19, from the last 5 days.
1. Policy Updates:
A. Pending Changes to the 2020 PCP QIP: Due to the extenuating circumstances related to COVID-19, PHC’s internal and external committees have made recommendations for changes to the 2020 Primary Care Provider Quality Improvement Program (PCP QIP). The Core Measurement Set will be modified to a smaller group of measures, with more attainable benchmark goals, as noted below.
Proposed Point Allocation and Threshold Changes:
|Family Practice||Internal Medicine||Pediatrics||50th Percentile|
|Clinical Measures||Points per measure||Full Points|
|Well-Child Visit, First 15 months of Life (W15)||15.0||25.0||65.83%|
|Controlling High Blood Pressure (CBP)||15.0||20.0||61.04%|
|Colorectal Cancer Screening (COL)*||12.5||20.0||32.24%|
|Diabetes – HbA1C Good Control <9 (A1c) (CDC)||12.5||20.0||50.97%|
|Childhood Immunization Combo 10 (CIS-10)||15.0||25.0||34.79%|
|Asthma Medication Ratio (AMR)||15.0||20.0||25.0||63.58%|
|PCP Office Visits**||15.0||20.0||25.0||TBD|
|TOTAL POINTS AVAILABLE||100.0||100.0||100.0|
* Colorectal Cancer Screening is the only measure in the PCP QIP that does not have an NCQA Threshold equivalent for PHC. The threshold here is the 25th percentile across the entire plan.
** The threshold for PCP Office Visits will be established after PHC has more data on the impact of the COVID-19 Pandemic and orders to shelter in place.
The specifications for measures in the Core Measurement Set are not changing, but some specification modifications are proposed for several Unit of Service Measures. Of note, we are lowering the thresholds for submission of attestations for advance care planning conversations and Advance Directives/POLST form updating. This is an excellent time to focus attention on this measure, as noted below.
This collection of changes is a proposal that is pending final approval and final specifications. Final approval will be obtained from our Physician Advisory Committee, in early May 2020. The final details and full specifications will be released by Mid-May 2020. We are informing you of the highlights of the Core Measure Set Changes so you can align your activities to this more focused group of measures.
B. Difficult Conversations in the Time of COVID-19. Geriatricians are noting greater receptivity to advance care planning conversations during the COVID pandemic. If your PCP practice has extra capacity, you may be considering outreaching to more vulnerable patients to update their advance directives and POLST forms. The Coalition for Compassionate Care of California is hosting a free webinar today at noon by an expert in palliative care communication, Robert Arnold. A recording of this webinar will be available afterwards on their website. An excellent prior webinar covering advance care planning in a virtual visit environment and other COVID-specific issues is also available, on the same page. The Coalition also has put together an excellent COVID Conversations Toolbox with other resources.
C. Presumptive Eligibility for Uninsured or Underinsured individuals with COVID. The Department of Health Care Services (DHCS) is creating a new aid code that will allow individuals to seek the necessary diagnostic testing, testing-related services, and treatment services, including all medically necessary care, through the Medi-Cal fee-for-service (FFS) program. This new aid code will be available to California residents with no insurance or who currently have private insurance that does not cover diagnostic testing, testing-related services, and treatment service, including all medically necessary care for COVID-19. It will be available, regardless of the person’s immigration status, income, or resources.
The covered diagnostic test, testing-related services, and treatment services, including all medically necessary care such as the associated office, clinic, or emergency room visit are paid up to the maximum FFS Medi-Cal rate. Individuals in this program will not be enrolled in a Medi-Cal managed care plan, so services must be billed through FFS.
D. DHCS requested flexibility on timing of Initial Health Assessments (IHA) for new Medi-Cal beneficiaries. CMS requires DHCS to require the health plans to ensure that all new Medi-Cal beneficiaries have an initial health assessment (a first visit, including a health screening with the DHCS’s Staying Healthy Assessment questionnaire. Normally this assessment includes an examination and must occur within 120 days of enrollment into Medi-Cal Managed care. Since a new Medi-Cal member has 1 month to select a PCP, the assigned PCP has about 90 days to complete this assessment.
Four days ago, DHCS requested the flexibility to have up to 180 days to complete this initial assessment. We will monitor this and inform you when CMS responds. In the meantime, as mentioned in the last email (related to state prisoner release), we hope you will develop a process for conducting new patient intake appointments through virtual visits.
2. Coronavirus PCR Testing
A. Quest issued an updated specimen collection guide (attached). This includes the methodology for collecting nasal swab specimens (which can be self-collected), as well as a number of permitted substitutions for scarce collection gathering supplies.
B. Scarce testing materials being spread out. Quest informed us that due to regulatory reasons related to responding to a shortage of supplies, testing materials that are sent out must be mostly used up before replacement testing materials are replenished. This means that most large volume testers will be frequently feeling like they are on the verge of running out of supplies. Close communication as any particular component of testing runs low is important.
C. Adapting testing recommendations in office setting as tests become more available. The CDC recommends that individuals with mild illness consult their medical provider to decide if they should be tested or not. Office- based testing criteria may be looser than County Health Department criteria for testing. If patient is staying at home anyway, there is little urgency in identifying milder cases of COVID.
As testing becomes more available, and as Stay at Home Orders are lifted, we must think differently about testing milder illness to identify clusters of infection earlier. County Health Departments will be involved in making recommendations to their local PCPs about testing criteria. If a PCP has plenty of testing capacity, be sure to let your local health department know, so they can guide you on what criteria to use to expand testing.
Examples of expanded testing strategies: The county health department may ask PCPs to assist with testing known contacts of confirmed COVID cases or doing follow up testing on patients with suspicious symptoms with a negative initial test, for example. They may ask a subset of providers to test all patients with mild respiratory symptoms as part of community surveillance or recommend testing anyone with any level of suspicious symptoms (something being done in Michigan). With sufficient capacity, some testing of asymptomatic essential workers (e.g. grocery store clerks, bus drivers, EMTs, hardware store workers) who are regularly exposed to the public may be helpful to prevent asymptomatic transmission. A hospital in New York tested all pregnant women arriving in labor, and found 14% of asymptomatic women tested positive, prompting precautions to prevent spread in the hospital.
These are but a few options. Developing a local strategy for scaling up testing as it becomes more available is worth a joint discussion between local clinicians and public health leaders.
D. PCR tests vs. Imaging for confirming COVID. The sensitivity of COVID PCR tests is fair (around 70%), and the results take a while to come back. An emergency room in New York found that half of all patients with COVID had an abnormal chest X-ray (usually bilateral, peripheral or basilar pattern, sometimes described as ground glass interstitial pneumonitis). A study in China, among patients admitted with COVID, found that 95% had an abnormal CT scan of a particular pattern. Some radiologists in the US have been hesitant to recommend using CT for diagnosis, citing concerns about the need to sterilize the CT scanner after scanning a patient with suspicious symptoms. As their primary justification, they state that there are methodological problems with the studies published so for on CT’s specificity for COVID.
Decisions to test a patient should not be dominated by concern over cleaning the equipment. If patient with hypoxia and a normal Chest X-ray is admitted to the hospital, given the differential diagnosis, a CT scan would often be helpful in ruling out non-COVID pathology, as well as helping with in-hospital disposition if the patient does have a pattern consistent with COVID, while awaiting PCR test results which have only a 70% sensitivity.
3. Coronavirus Antibody Tests (Thanks to Dr. Marshall Kubota for gathering these studies)
A. Pattern of Development of Neutralizing Antibodies. A Chinese study of 175 patients with COVID found that SARS-CoV2 specific neutralizing antibodies developed starting 10-15 days after “onset of disease.” Patients with milder disease had lower plasma titers of these antibodies than those with more severe disease. Ten patients with confirmed COVID had undetectable antibodies, suggesting either a poor response or perhaps that the PCR test/clinical diagnosis had a specificity of 94% to match its sensitivity of 70%.
B. Similar pattern of antibodies was found in a Norwegian Study of H1N1, which found that 2/46 patients diagnosed with mild H1N1 had no detectable antibodies to H1N1. Again, this may reflect either a poor generation of an immune response or a specificity of 96% in the initial diagnostic test for H1N1.
C. Other Coronaviruses Exhibit waning Immunity over Time. Interviews of experts by NPR noted that the more benign coronaviruses that cause the common cold can cause repeat sickness, even if a person has a documented prior antibody response. Speculations on potential reasons include genetic variation of the virus over time or some other factor that impacts the effectiveness of antibodies from prior infection. Since classic SARS was found to have a more robust and long-term immune response, and they were all symptomatic with serious infection, this supports the hypothesis that surviving more serious illness generates a longer-lasting and stronger response.
4. Bio-aerosols and masks
A. The study that prompted CDC to recommend wearing face coverings in public showed that surgical masks reduced coronavirus detection and viral copies in large respiratory droplets and aerosols from exhaled breathing (versus coughing, in which some spread occurs with any facial covering).
B. Another study pointing toward potential aerosol spread was done at the US biohazard containment center in Nebraska. Presented at a National Academy of Science Webinar, Dr. John-Martin Lowe showed that viral RNA was detected at distances greater than 6 feet from 82% of COVID positive outpatients in a quarantine facility and was also detectable in air samples in the hallways outside the patient rooms. It is not known yet if this viral DNA was part of infectious viral particles. In the Q&A, Dr. Lowe quoted a Singaporean study that showed that viral RNA was found on particles 1-4 microns in size (bio-aerosol size). He said it was better to think of Droplet and Aerosol as being part of a continuum of infectiousness and infectivity in COVID. This means that perhaps the aerosol infectivity is less than measles, it can still be transmitted via aerosols, particularly in closed spaces where the infectious aerosols can build up in concentration to a dose sufficient to infect those who spend time in that space.
C. Dry heat better than autoclave for sterilizing N95 masks for re-use. (Thanks to Dr. Mills Matheson for finding this reference.) In an earlier email a couple of weeks ago, I reviewed an article showing that autoclaving preserved filtration better than alcohol, ultraviolet light and gas sterilization. A better study looking at various conditions shows that heating masks to 170-200 degrees Farenheit for 30 minutes resulted in a trivial loss of filtration, even when repeated 20-50 times. Filtration started to drop off steeply at temperatures over 212 degrees. Steam resulted in greater loss of filtration integrity (about 2% per steam cycle), explaining why autoclaved N95 masks should probably be discarded after just a few autoclaved cycles, and why the rice cooker sterilization method mentioned in a prior email is done without adding water to the rice cooker. A CDC summary of methods of re-using N95 is not very helpful, listing many options but not distinguishing between them very well.
5. Other Scientific Updates
A. Case report of Guillain Barre syndrome associated with onset of COVID (“parainfectious profile”) instead of “postinfectious profile” seen with Zika and other viruses.
B. Studies of Compassionate Use of Convalescent Plasma. The same NAS webinar as noted above described the state of knowledge of studies of using plasma from patients who have recovered from COVID to treat critically ill patients with COVID. Earlier studies in classic SARS found a tripled survival rate associated with this treatment. Starting March 24, the FDA has allowed compassionate use of convalescent plasma to treat COVID. A clinical trial was started on April 3 at Johns Hopkins. On April 8, the FDA published recommendations on its use. Blood banks can collect plasma from patients recovered from COVID. See the American Red Cross website for screening criteria. For a moving account of one New York City Oncologist’s effort to find matching plasma for her critically ill brother-in- law’s father, see this article in the Atlantic. One recovered patient’s plasma can be used to treat 3 critically ill patients.
C. Compassionate Use Experience of Remdesivir. This summary of experience with the use of Remdesivir based on compassionate use in hospitalized patients suggested better outcomes compared to historical experience. Controlled trials are in progress.
6. On a lighter note: Personalizing care while wearing full PPE: put your portrait onto your gown.
See this document for details, credits and a how-to guide. “PPE Portraits are simply disposable portrait picture stickers (4×5) put on PPE – personal protective equipment. Anecdotal pilot data captured during treatment of Ebola showed the PPE Portrait Project helped patients feel connected to their caregivers, and helped healthcare workers feel more like a team and less dehumanized, though this has yet to be formally studied. From a placebo standpoint, we know that provider warmth and competence are positively associated with physiological health biomarkers. From our standpoint, PPE signals competence; portraits could be one of the only signals of warmth for COVID19 and potentially-COVID19 patients.”
Thanks for your hard work and innovative spirit in this challenging time!