Category: Breaking News

Every residential address in the US can order four rapid antigen test (RAT) kits for free, expected to be delivered in late January, through an official government web page: covidtests.gov (which currently redirects to a site operated by the US Postal Service special.usps.com/testkits). Persons need enter only their name and shipping address to place a free order, and optionally can enter an e-mail address to be notified about order progress. The ordering system opened publicly one day earlier than had been announced.

According to the web page, “the tests available for order: are rapid antigen at-home tests, not PCR; can be taken anywhere; give results within 30 minutes (no lab drop-off required); work whether or not you have COVID-19 symptoms; work whether or not you are up to date on your COVID-19 vaccines; [and] are also referred to self-tests or over-the-counter (OTC) tests.” It is recommended to take an at-home test “if you begin having COVID-19 symptoms like fever, sore throat, runny nose, or loss of taste or smell; or at least 5 days after you come into close contact with someone with COVID-19; or when you’re going to gather with a group of people, especially those who are at risk of severe disease or may not be up to date on their COVID-19 vaccines.”

The federal government maintains a web resource of physical locations where COVID-19 testing services can be obtained, often at no cost: hhs.gov/coronavirus/community-based-testing-sites/index.html

This free program is separate from and in addition to a federal mandate that private health insurers either directly cover or indirectly reimburse each insured individual for up to eight at-home over-the-counter RAT kits per month, up to $12 per test. Families on the same insurance plan are eligible for RAT kits on an individual basis, so a family of four would be eligible for eight each, or 32 tests, per month.

Coverage applies equally regardless of whether the private health insurance plan is purchased directly or as part of a group such as through an employer. Most insurers will pay directly for the tests at point of purchase, such as an in-network pharmacy, much the same as prescription drug coverage, but otherwise may require the insured person to pay up-front and submit receipts for reimbursement.

Each person covered by Medicaid (but not Medicare) or Children’s Health Insurance Program (CHIP) programs is eligible for direct purchase of up to eight RAT kits per month from any in-network pharmacy with no cost or co-pay.

Medicare (as opposed to Medicaid) pays for laboratory tests but not at-home tests, and may require prescription by a health professional; however, some Medicare Advantage programs may cover at-home tests, so it is necessary to check the specific plan.

Dr Nicole Alexander-Scott, MD, MPH, who has served as director of the RI Department of Health (RIDOH) since 2015 and spearheaded the state’s response to the COVID-19 pandemic from the beginning, has resigned effective two weeks from today, according to a statement from Gov. Daniel McKee, and the governor “regretfully accepted.” She will continue in a consulting role for three months following her departure to assure continuity, the statement said.

Alexander-Scott had her own encounter with the virus, testing positive on Dec 12, 2020, leading to then-Gov. Gina Raimondo, Commerce Secretary Stefan Pryor, and vaccine expert Philip Chan, MD, of RIDOH and Brown University School of Medicine observing a precautionary quarantine as close contacts.

A native of Brooklyn, NY, Alexander-Scott is a nationally recognized expert in her field. She completed a four-year combined fellowship in infectious diseases of adults and children at Brown University, after finishing a combined internal medicine and pediatrics residency at SUNY Stony Brook in 2005 and medical school at SUNY Syracuse in 2001. She obtained a master’s degree in public health (MPH) from Brown in 2011. The statement from the governor noted that she is one of the five longest-serving state public health leaders in the nation.

“Dr. Alexander-Scott has been a steady, calm presence for Rhode Island as we’ve worked together to fight the COVID-19 pandemic,” said Governor Dan McKee in the statement. “Her leadership has been crucial to our whole of government response – helping Rhode Island become number one in testing nationwide and getting more people vaccinated per capita than nearly any other state in the country.”

“Serving as the director of the Rhode Island Department of Health has been the most rewarding experience of my career,” said Dr. Nicole Alexander-Scott. “I would like to thank all Rhode Islanders for their trust over the past two years as we have navigated this unprecedented public health crisis together. It has been an honor to serve you. I would also like to thank all the healthcare providers and community partners who have supported the work we have been doing at RIDOH since 2015 to ensure that everyone has an equal opportunity to be healthy, regardless of their ZIP code, race, ethnicity, sexual orientation, gender identity, level of education, or level of income. And finally, I would like to express enormous gratitude to the members of my RIDOH family. They embraced me, taught me, challenged me, picked me up when I was down, and had my back every step of the way.”

In addition to co-leading the state’s response to the pandemic, the statement noted, Alexander-Scott established the Health Equity Zone program that has become a national model for how to situate needed health care facilities in underserved areas in collaboration with local community leaders, led the response to the opioid crisis by getting naloxone (Narcan) into the hands of first responders and private individuals as well as opening some of the first harm reduction centers in the country, and arranging $82 million in financing to replace the state health laboratory with a “new Rhode Island Center of Excellence for Laboratory Sciences [that] will make Rhode Island better prepared for any future epidemic or pandemic with improved public health services, be an economic driver for the state, and foster more collaboration with private industry and academic institutions.”

(App download links at end of article.)

RI has updated and renamed its “401Health” app (previously “Crush COVID RI”) for Google Android and Apple iOS, the office of Gov. Daniel McKee announced today. The main purpose of the update is to add support for displaying the user’s vaccination record via a securely trusted QR code, which can be read by another app, the SMART Health Card Verifier, also available for both Android and iOS. The updated app continues to support previous features such as maintaining a private diary that the user can choose to share with contact tracers should that be necessary, links to schedule tests and vaccination doses, and access to display published statistical data about the COVID-19 situation in the state.

The two components, the record holding app and the verifier app, depend upon cryptography to assure the record comes from a trusted issuer, such as the State of Rhode Island, and has not been tampered with or modified. The system is similar to how web browsers handle sensitive information, such as credit card numbers for on-line purchases. In theory a QR code record could be printed out onto physical paper to be scanned by a verifier, but it is unclear at this time whether the RI apps or web sites will support this in addition to dynamic on-device display.

In order to make this work, RI has joined the SMART Health Card Framework administered by the Vaccine Credential Initiative (VCI), a non-profit coalition of government and non-government health care and technology organizations headquartered from Boston-based MITRE Corporation (formerly “MIT Research”) using an open-source public protocol specification licensed by Boston Children’s Hospital. The Framework is supported worldwide, including in the US, Canada, the UK, Japan, and Israel. The full technical specification details, as with many open-source projects, are publicly downloadable from GitHub.

The Framework is only a set of specifications, and it is up to the SMART Health Card Verifier App, published by the Commons Project, to implement the verification process, scanning and testing presented credentials (a QR code) against the CommonTrust Network’s Registry of trusted record issuers, also maintained by the Commons Project.

VCI publishes a “Code of Conduct” that “expects verifiers to adhere to the following core set of requirements in order to protect and properly interpret SMART Health Cards: Verifiers shall not store SMART Health Cards, or any data included within them, beyond what is required for verification at the time of presentation. Verifiers shall check SMART Health Cards against a list of trusted issuers. Verifiers shall comply with all applicable laws, including the California Consumer Privacy Act.”

According to the Computational Health Informatics Program (CHIP) at Boston Children’s Hospital that licenses and administers the underlying system, “SMART Health Cards contain just the information required to display your vaccination history and/or test status, and the choice to share your Card is up to you. In most cases that means: They contain: Your legal name and date of birth; Your clinical information; Tests: date, manufacturer, and result; Vaccinations: type, date, and location. They should not contain: Your phone number; Your address; Your government-issued identifier; Any other health information.”

The governor’s office said in its statement, “The VCI coalition prioritizes privacy and security of patient information, making medical records portable and reducing healthcare fraud.”

According to the Commons Project, their SMART Health Card Verifier App will “Quickly scan a SMART Health Card to confirm COVID-19 vaccination using the Verifier app at your small business, live music venue, school, or sporting arena. Scanning a SMART Health Card QR code reveals: Whether the SMART Health Card is valid; Whether the issuer is in The CommonTrust Network’s Registry of trusted issuers; [and] Key information on the SMART Health Card (issuer name, vaccine type, dates of vaccine doses, and name and date of birth of vaccine recipient).”

“By embracing the open-source SMART Health Card Framework, Rhode Island joins seven states, numerous countries, and pharmacies such as CVS, Walgreens, Rite Aid, and Walmart that are already utilizing the secure SMART Health vaccination technology for record standardization. The State looks forward to partnering with Connecticut and Massachusetts as they onboard in the coming weeks and months,” McKee’s office said in its statement.

“Rhode Island has administered close to 2 million doses of COVID vaccine and almost 300,000 booster doses, and our neighbors deserve a convenient, safe, and efficient way to access and store their vaccination record,” McKee was quoted in the statement saying. “I have downloaded my vaccination card to my phone and it was very simple. If you haven’t gotten vaccinated yet, it’s not too late. If you haven’t yet, get boosted.”

“We want to make it as easy and convenient as possible for you to securely access your vaccination information,” Department of Health Director Nicole Alexander-Scott was quoted saying in the statement from the governor’s office. “This new app is a great way to verify for others that you have received the critical protection that comes with a COVID-19 vaccine primary series and booster dose.”

401Health RI app
Google Android	play.google.com/store/apps/details?id=com.ri.crushcovid
Apple iOS	apps.apple.com/us/app/crush-covid-ri/id1511308593
SMART Health Card Verifier app
Google Android	play.google.com/store/apps/details?id=com.thecommonsproject.smarthealthcardverifier
Apple iOS	apps.apple.com/us/app/smart-health-card-verifier/id1572691390

Treatment with monoclonal antibodies (MABS) is recommended and authorized to keep patients who test positive for COVID-19 out of the hospital, reducing the severity of mild to moderate symptoms. The treatment is done on an outpatient basis by a one-time infusion that takes several hours. In RI, however, there is a logistical backlog on quickly delivering MABS treatment to patients.

Motif was approached by a reader who tested positive on Friday, Dec 10, but was told the earliest opportunity for MABS treatment would be Wednesday, Dec 15. In response to our inquiry, RI Department of Health (RIDOH) spokeswoman Annemarie Beardsworth confirmed that “most MAB providers are scheduling three or four business days after a patient’s/provider’s request. This time-frame is due to the very high demand occurring currently, but is also exacerbated by patients and/or healthcare providers calling multiple MAB infusion sites to see where they can get an appointment soonest, scheduling multiple appointments at different MAB infusion sites, and then not canceling appointments they don’t attend. This causes a tremendous amount of unnecessary administrative burden on the MAB providers and slows down the scheduling process.” She continued, “Unfortunately, when patients do not cancel appointments they don’t plan to attend, it prevents other patients from using that appointment slot. Some MAB providers tell us they can see as many as 8-10 no-show appointments per day. RIDOH reminds all patients to cancel any MAB appointments they are not planning to attend so that other patients can get their needed treatment.”

There are logistical obstacles beyond just patient no-show appointments, Beardsworth told Motif. “Rhode Island has an adequate supply of MAB product in Rhode Island and we have been administering at a very high rate of our biweekly federal allocation. Like most other states in the country, Rhode Island is experiencing a healthcare worker shortage, so there are fewer providers than we’d like who can administer MAB. RIDOH is actively working to recruit and onboard more MAB providers. The MAB that is the easiest and fastest to administer is in short supply federally, so combined with fewer providers who can administer MAB, each administration takes longer when using the other infusion (IV) products.”

While three or four business days is still within the 10-day limit after onset of symptoms, almost a year ago when the treatment was first made available in RI, on Friday, Jan 8, 2021, RIDOH Director Nicole Alexander-Scott said, “Rhode Island now has a doctor-recommended treatment for COVID-19 that is extremely effective at preventing people from developing severe disease and from being hospitalized because of COVID-19. The key, though, is starting early: The earlier you start treatment after testing positive, the better and more effective this can be. After completing a simple infusion, intravenously, of this treatment, many people with COVID-19 start feeling better as early as the next day. The treatment does not require hospitalization, and it’s intended to help prevent people from actually having to be hospitalized.” (See “New Treatment Available: Monoclonal antibody treatments for all eligible RI patients”, by Michael Bilow, Jan 9, 2021.) At that time, she said the plan was to have infusion sites co-located with larger testing sites, so that eligible patients can get the new treatment immediately after testing positive by a rapid test. “We’re working to build out as many different infusion sites as possible, particularly at places where there is a lot of testing already occurring, so that you can just go to the next room if you’re at one of our testing sites that’s able to accommodate this and get access to the treatment. We want to get at every element,” Alexander-Scott said.

It stands to reason that patients would benefit from following longstanding RIDOH advice to get tested as soon as possible after symptom onset and to seek MABS treatment, if indicated, as soon as possible after a positive test result.

The RIDOH website – covid.ri.gov/covid-19-prevention/treatment – has information about who is eligible for MABS: “You can use MABS if you test positive for COVID-19, started having mild to moderate symptoms in the past 10 days, and are at high risk for progressing to severe disease.” It also describes who should not get MABS, how to obtain MABS if you have no primary health care provider or no health insurance, and lists – covid.ri.gov/mabs-infusion-services – MABS infusion service providers.

Omicron has been detected in RI, according to an announcement this afternoon from the office of Governor Daniel McKee. “The individual who tested positive is a person in their 20s who lives in Providence County and recently returned from travel in New York. The individual completed a primary vaccination series and had no record of a booster shot. Contact tracing on this case is ongoing,” the statement said.

Classified as a “variant of concern” by the World Health Organization and assigned the Greek letter “Omicron” as a mnemonic, the variant (also known as “B.1.1.529” in the PANGOLIN nomenclature) of the SARS-CoV-2 virus that causes COVID-19 was first detected in South Africa in a specimen collected on Nov 9 and has since been observed worldwide, in the US first on Dec 1 and in 22 states as of Dec 8, according to an early release issued yesterday in the flagship Morbidity and Mortality Weekly Report (MMWR) by the US Centers for Disease Control and Prevention (CDC). The CDC said that of 43 Omicron patients so far identified in the US only one had been hospitalized (for two days) and none had died. (See “Omicron virus ‘variant of concern’: More transmissible, unknown if otherwise more dangerous”, by Michael Bilow, Nov 26, 2021.) While the scope of the threat may not be assessed for a few more weeks, the CDC warned that “Mutations in Omicron might increase transmissibility, confer resistance to therapeutics, or partially escape infection- or vaccine-induced immunity.”

In general, viruses mutate frequently but most mutations have no practical effect while a few mutations can give the virus a reproductive advantage, which first happened with the variant designated as “Alpha” (B.1.1.7) and later with the variant designated as “Delta” (B.1.617.2). (See “Don’t Panic: Explaining coronavirus mutations”, by Michael Bilow, Dec 26, 2020.) Despite the heightened concern about Omicron, the CDC said, as of the week ending Dec 4, nationally the Delta variant is currently estimated to account for 99.9% of infections because its significantly greater transmissibility allowed it to supplant prior variants.

The statement from his office quoted Gov. McKee: “We fully expected that Omicron would eventually be detected in Rhode Island as it has been in our neighboring states. I want to be clear: Rhode Island is prepared. This is not cause for panic.” The statement also quoted RI Department of Health (RIDOH) Director Nicole Alexander-Scott: “Given the recent findings of the Omicron variant in our region, it is not at all surprising that we have identified this case in Rhode Island.”

“The case was identified through the ongoing genomic surveillance program coordinated by RIDOH’s State Health Laboratories,” the statement said, quoting Alexander-Scott: “I want to thank the staff at our State Health Lab who have been working diligently to sequence more test results than ever before. Together, we can keep each other safe and healthy throughout the holiday season.”

Both McKee and Alexander-Scott emphasized that the best protection measures against the Omicron variant are the same as against the Delta variant: get vaccinated including a booster shot if eligible, practice proven public health measures such as wearing a face covering indoors and in crowded public places, maintain physical distancing, use proper ventilation, and be tested regularly. The statement said: “COVID-19 vaccine helps protect against the Omicron variant of COVID-19. However, booster doses are particularly important in providing additional protection. Everyone older than 5 years of age should get a primary series of COVID-19 vaccine. Everyone older than 16 should get a booster dose. (If you got Pfizer or Moderna for your primary series, you should get a booster dose at least six months later. If you got Johnson & Johnson [Janssen] for your primary series, you should get a booster dose at least two months later.)”

The statement said that Gov. McKee “will be announcing a comprehensive set of actions early next week to address the increased number of COVID-19 cases and alleviate pressures on our hospital systems while at the same time keeping our schools open for in-person learning and preventing economic disruptions to our small businesses. The comprehensive set of actions the governor is focused on are vaccination, testing, masking and staffing capacity. The governor is continuing to meet with his whole of government team over the weekend to finalize the executive actions he will undertake.” Although McKee said at his regular weekly press conference on Thursday that he was reluctant to resume restrictions from earlier in the pandemic such as lockdowns or indoor masking mandates, he was clear that all options were on the table.