April 13 COVID-19 Update – Pennsylvania American College of Physicians

April 13 Pennsylvania COVID-19 Update

On Sunday the Department of Health reported that Pennsylvania had found another new 1,178 positive cases in the previous 24 hours, for a total of 22,833. The death total rose to 507 deaths, with 13 reported on Saturday, all in adult patients. There were 102,057 negative tests in PA as of midnight Saturday night.

At Sunday noon, approximately 2,101 COVID-19 patients were hospitalized.  At that time, 653 were using ventilators or ECMO.

Sunday afternoon,  46% of beds, 38% of ICU beds are available, and 1471 of 4911 ventilators were in use (just about 70% of ventilators were still available.) 
Of the patients who tested positive to date the age breakdown was unchanged from Saturday: less than 1% are aged 0-4; less than 1% are aged 5-12; 1% are aged 13-18; 7% are aged 19-24; 41% are aged 25-49; 29% are aged 50-64; and 21% are aged 65 or older. 

51% of the patients hospitalized are aged 65 or older, and 28% are aged 50-64.  19% are ages 25-49.  Most of the deaths have occurred in patients 65 or older. There have been no pediatric deaths to date.

Saturday’s numbers:
On Saturday the Department reported that Pennsylvania had found another new 1,676 positive cases in the previous 24 hours, for a total of 21,655 in all 67 counties. The death total rose to 494 deaths, with 78 on Friday, all in adult patients. There were 98,498 negative tests in PA as of midnight Friday night.

The Secretary noted that of the positive cases, 1,067 cases have been in health care workers, an increase of 112 since Friday (a 11.7 percent increase), and another 1,409 of the positive cases facilities are in 195 of the state’s licensed long-term care (up from the 181 facilities reported on Friday).

Percentages of those testing positive did not change significantly from Friday afternoon.  Approximately 2,189 patients are currently hospitalized.  At this time, 650 are using ventilators or ECMO.

As of noon, 46% of beds, 38% of ICU beds are available, and 1444 of 5036 are in use (nearly 70% of ventilators are still available.) 

To date, PA has supplied 1.8 million N-95 masks,  136,000 gowns 912,000 hospital masks 730,000 pairs of gloves, 990 goggles and 147,000 face shields to hospitals, senior facilities and emergency services workers.
More than 30 waivers have been issued by the Department of State in response to the coronavirus emergency. The links below offer information on some of the waivers that have been announced over the past several weeks.
Waivers that have been granted to healthcare practitioners include:

Trump Administration requires insurers to provide free COVID-19 antibody tests
The CMS and federal Departments of Labor and Treasury issued guidance Saturday to ensure Americans with private health insurance have coverage of 2019 Novel Coronavirus (COVID-19) diagnostic testing and certain other related services, including antibody testing, at no cost.  

The major health insurance companies had met with President Trump, and committed to covering COVID-19 testing without cost sharing such as copays and coinsurance.  Saturday’s announcement requires group health plans and group and individual health insurance to cover both diagnostic testing and certain related items and services provided during a medical visit with no cost sharing.

This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states. It also ensures that COVID-19 antibody testing will be covered.  The guidance is online at: https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf
DHS Adds Short-acting beta agonist metered dose inhalers to Statewide Medicaid Preferred Drug List
The Department of Human Services Office of Medical Assistance Programs has added several short-acting beta agonist metered dose inhalers to its statewide Medicaid Preferred Drug List  to cope with the shortage of albuterol HFA in the marketplace.  These products will remain on the preferred list until an adequate supply of albuterol HFA is available.  The list of those inhalers is available online here.
PA Health Action Network announces Interim Guidelines for serologic testing, COVID-19 Diagnostics
A summary of the alert:

  • Two nucleic acid amplification-based tests have been granted an Emergency Use Authorization by the Food and Drug Administration for point of care (POC) use.
  • There are no serological tests that are approved for use in POC setting.
  • Serology cannot be used to diagnose infection with SARS-CoV-2.
  • There are no CDC guidelines for interpretation of COVID-19 serology tests.
  • Results from serology testing should not be used as the sole basis to diagnose or exclude COVID-19 infection or to inform infection control.

Recently updated policy from the Food and Drug Administration (FDA) has led to some confusion around serology tests. It is the healthcare provider’s (HCP) responsibility to ensure that all testing performed in the HCP’s practice is in compliance with applicable regulations.

Note that a list of tests that have been granted an Emergency Use Authorization (EUA) by the FDA for detection and/or diagnosis of SARS-CoV-2 can be found here. Included in that list are two nucleic acid amplification-based tests that have been approved for point of care (POC) use (Abbott ID NOW and Cepheid XpertXpress). This means that these two POC tests can be used in clinical practice.

There are currently no serology tests that have received FDA EUA for use in the POC setting. Serology cannot be used to diagnose infection with SARS-CoV-2, and there are no CDC guidelines for the interpretation of serology tests.

Please see the FDA’s frequently asked questions (FAQ) site here for more information. The first two questions in the “General FAQs” section were recently updated and provide more clarity on the use of tests that have not been granted an EUA. In short, serology tests without an EUA have not been categorized by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and therefore are considered “high complexity” tests by default and may only be performed in a laboratory that meets the CLIA requirements to perform this class of tests.

Negative serologic test results do not rule out SARS-CoV-2 infection, particularly in people who were exposed to the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

These serologic tests have been known to cross-react with other strains of coronavirus. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Serology tests being made available under section IV.D. of the FDA Policy for Diagnostic Tests for Coronavirus Disease-19 are listed in the FDA FAQ (see the “What Laboratories and Manufacturers are Offering Tests for COVID-19?” section). Note that these serology tests have not been reviewed by the FDA, have not been granted authorization or approval by the FDA, and cannot be performed in a CLIA-waived or moderate complexity laboratory setting. DOH is aware that some of these serology tests are being falsely marketed as “FDA authorized” or “FDA approved” and as CLIA-waived POC tests, which they are not. The performance of these serology tests has not been appropriately evaluated or reviewed, and using these serology tests may put HCPs, patients, and contacts in danger due to incorrect results leading to inappropriate action.

Providers and laboratories are responsible for ensuring that any testing performed is done so in compliance with all applicable state and federal regulations. Please ensure that any testing offered in a facility meets all applicable regulatory requirements.

Philadelphia Court Suspends Depositions and Required Appearances during COVID-19 Response

PA-ACP had opposed action in the state Courts that would have allowed trial lawyers to continue depositions and discovery actions with physicians during the COVID-19 crisis.  Late last week, after the Supreme Court had left these decisions to Courts of County Pleas, the Philadelphia Common Pleas Court directed that, consistent with Governor Wolf’s Order dated March 21, 2020, “depositions of and required appearances for doctors, nurses, or other healthcare professionals who are substantially involved in responding to the COVID-19 public health emergency are suspended.
Saturday Questions to Dr. Levine:
The Lehigh Valley Health Network has said it is short on testing supplies – with sparing tests, how will number of positives be counted?  How will we know when it’s safe to lift restrictions?  LEVINE: We have had occasional shortages of chemicals and reagents, and we will reach out to LVHN.  Two mass testing sites – one in Philadelphia was closed.  The Montgomery County site is moving to a new site to reopen. And we are hoping for a new site in the northeast.  As to the difference between confirmed and probable cases, we’re comparing data.   But close contacts of those in same household are considered probable cases.  We’ll look at many different factors, and the reopening with be gradual, based on a number of factors and discussions with people in those counties.  The mitigation efforts the Governor has put into place – please stay home.

You’ve said that overall PA still has enough beds etc. to help Pennsylvanians.  How many beds to we have and where?  LEVINE: We have county specific info available on the website.  In Philadelphia and NE PA, we do have enough beds, but we’re watching closely.

Now that there have been several hundred workers at Cargill is it safe to eat meat at grocery stores?  LEVINE: We have no evidence that the Coronavirus could survive the freezing process – we have confidence in our food supply.

Is Department looking into this?  LEVINE: Guidance for individuals in food processing plants is coming this weekend.  We have complete confidence.

What about social distancing on the street?  How do you navigate from people in cities?  LEVINE: It’s more difficult, which is why we want you to stay home.  If you are out, stop while they pass, cross the road, but don’t get hit by a car(!)

What’s your response to legislation from House GOP to reopen the state?  LEVINE: The Governor and cabinet do understand the significant economic challenges to the commonwealth and the nation, but from a public health perspective, it’s absolutely critical that we’ve put these mitigation practices into play. Especially now, please stay home.  We understand their concern, but now is not the time.  But that will not be forever – working on plans for when and how, but will be in a progressive, iterative fashion.  We have significant new numbers.

Describe how things will open up?  LEVINE: We are watching many factors – number of cases, number new cases, percentage of lab results that are positive per capita.  When we see COVID is going down, all going down and much less community spread, then it will be time to discuss lifting the orders in a progress
ive way, watching for new spikes and new outbreaks – per Fauci and Birx

What about churches keeping their doors open because their parishioners don’t have internet?  LEVINE: I understand, but it is dangerous to be out congregating with other people, so my recommendation is to practice social distancing and celebrate with your family.

What about medical rationing guidelines? When released?  LEVINE: I wouldn’t call them that – finishing up standard crisis standards of care out later this weekend.

How does the daily number of positive tests play into decision making?  LEVINE: It was exponential, almost a straight line, but through the mitigation, we’re still seeing new cases every day but not as many as before and not growing as quickly.  There will be a wave of cases that will come up, but hopefully it won’t be a tidal wave.

What about the surge?  We’ve heard that the surge in central PA is still weeks away – do you concur?  LEVINE: Models we’re watching, show a surge in SE and NE in next week or more, potential surges in other areas, certainly west, later than now.  We’ll be watching the data, and models, but the “Virus determines the timeline.”

Why were the larger test sites closed?  Isn’t it too soon to close them when testing is already limited? LEVINE: There was concern, but thanks to our congresspeople, we are able to keep sites open.  Philadelphia decided they didn’t need that site, so it wasn’t necessary.  In Montgomery County it will reopen.

Is there progress in testing for antibodies for those testing positive?  Will that tell us if they are immune?  LEVINE: We are looking forward to antibody testing, It will be really useful to test people in health care, food workers, nursing facilities targeted testing to see who’s immune.  Looking forward to its introduction.

Is it reasonable to assume the stay at home order lasts as long as school closings – June 4?  LEVINE: We’ll make that determination, but I can’t give you a date.

Is there a role for phone Apps as a technology to help move out of this?  LEVINE: We’re starting to look at that, including thermometer applications, and other technology.
General Assembly
The State House of Representatives has been called back to session by Speaker Mike Turzai for non-voting session April 13 and voting session on Tuesday April 14. Turzai advised all members in advance that the Republicans would have a quorum filling 102 members present in Harrisburg for the session.

​This weekend, Turzai told Democratic leadership that he intended to consider legislation which would override the Governor’s emergency declaration and orders concerning essential life-sustaining businesses, particularly small businesses.