Combating the Novel Coronavirus (COVID-19): Week of June 20

MHA Covid-19 update

MHA Covid-19 updateAs of June 22, there were 714 adults and 27 children in Michigan with confirmed or suspected cases of COVID-19, with new cases averaging 1,780 per day the previous week. Over 100 hospitalized adults were being cared for in intensive care units. According to the state’s vaccine tracker, 67.4% of Michigan residents had received at least one dose of a COVID-19 vaccine as of June 22.

The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Children Ages Six Months Through Five Years Eligible for COVID-19 Vaccine

The Michigan Department of Health and Human Services (MDHHS) announced June 21 that all Michiganders ages six months and up are now eligible for a COVID-19 vaccine. The pediatric vaccine, which received emergency use authorization for this age group from the Food and Drug Administration, was recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices June 18. The MHA released a media statement following the CDC recommendation, which makes 500,000 more Michigan children eligible for vaccination.

The MDHHS is recommending providers begin vaccinating children ages six months and older as soon as possible. The Moderna series is two doses given 28 days apart for ages six months through five years. For children six months of age through four years, the Pfizer series is three doses, with the first two given three weeks apart and the third dose administered at least eight weeks after the second dose. For ages five and older, the Pfizer series is two doses given 21 days apart.

In addition, the CDC has issued important updates to the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. The MDHHS has provided an outline of the updates. The updates are outlined in the attached communication from MDHHS.

Questions about COVID-19 vaccines should be directed to Ruthanne Sudderth at the MHA.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Nov. 15

MHA Covid-19 update

MHA Covid-19 updateMichigan is once again among the states with the highest numbers of COVID-19 cases in the nation, with the New York Times reporting that Michigan and Minnesota lead the country in cases per capita. On Nov. 19, there were 3,424 adults hospitalized with confirmed cases of COVID-19, in addition to 50 children. Meanwhile, 60.3% of Michiganders aged 5 and older had been fully vaccinated as of Nov. 19.

The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

FDA Amends EUA to Allow Booster Shots to Fully Vaccinated People Aged 18 and Up

The Food and Drug Administration (FDA) amended the COVID-19 vaccine emergency use authorizations (EUAs) Nov. 19 to allow all individuals 18 years of age and older to receive booster shots of both the Pfizer and Moderna vaccines. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) was scheduled to meet later that day to discuss additional clinical recommendations.

In its news release, the FDA said the expanded authorization for the booster doses is based on its analysis of immune response data that supported use in the previously authorized populations for boosters. Groups previously included in the EUAs were fully vaccinated individuals who are 65 years of age and older and who are 18 through 64 years of age at high risk of severe COVID-19 and/or experience frequent exposure to the coronavirus through living situations or workplaces.

Prior to the FDA announcement, Gov. Gretchen Whitmer encouraged residents to plan to get the booster doses as soon as they are authorized. The governor noted that more than a million booster doses have been administered within the state and urged everyone to get vaccinated and receive the booster shot.

Booster doses should be administered at least six months after the second dose of either the Pfizer or Moderna vaccine and at least two months following the single-dose Johnson & Johnson vaccine. Updated information for both the Pfizer and Moderna vaccines are available on the FDA website that provide details on the booster shots.

Members with questions on vaccines may contact Ruthanne Sudderth at the MHA.

MDHHS Announces Face Mask Advisory for Holiday Season

As both COVID-19 and influenza cases rise throughout the state, the Michigan Department of Health and Human Services (MDHHS) will issue a face mask advisory and offer guidance to prevent the spread of respiratory diseases during the holidays.

The department’s news release indicates it recommends everyone over the age of 2 wear a face mask at indoor gatherings regardless of their vaccination status. Establishments are also urged to implement policies to ensure that customers, employees and visitors wear masks. The advisory will remain in effect until further notice.

During a Nov. 19 news conference, MDHHS Director Elizabeth Hertel, Chief Medical Executive Natasha Bagdasarian, MD, and others also urged Michigan residents to get vaccinated against COVID-19 and the flu as soon as possible. The two vaccines can be administered simultaneously. Darryl Elmouchi, MD, MBA, president of Spectrum Health West Michigan, shared information about the unprecedented numbers of patients hospitals are seeing. He said Spectrum Health has 370 patients hospitalized with COVID-19, 86% of whom are unvaccinated against the disease.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpageQuestions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Oct. 11

MHA Covid-19 update

MHA Covid-19 updateAs federal regulatory agencies evaluate COVID-19 vaccine and treatment possibilities, more than 5.5 million Michigan residents ages 16 and older have received at least one dose of a vaccine to protect them against the deadly disease, equating to 68.2% of that population as of Oct. 15. Meanwhile, despite the rate of new cases decreasing in many of the states that had been experiencing a surge in hospitalizations and deaths, cases in Michigan have been increasing. Nearly 8,300 new cases were reported for Oct. 14 and 15, with 2,010 adults and 29 children hospitalized in the state Oct. 15. Total deaths in Michigan attributed to confirmed cases of COVID-19 reached 21,563 Oct. 15.

The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Moderna Expiration Date Extended for Frozen Vaccines

The Michigan Department of Health & Human Services (MDHHS) announced Oct. 13 that Moderna received approval for a two-month extension of FROZEN Moderna COVID-19 vaccine. Some lots with an initial expiration of September or October will be extended if stored in frozen stateSeventy-eight lots are impacted by this extension.

The MDHHS does not have a list of these lot numbers, but Moderna is working diligently to get the extended lots updated in their tools and databases, with a priority on older lots first. To look up Moderna expiration, scan the QR code located on the carton or use the company’s expiration date lookup feature on its website. Healthcare providers are encouraged to continue checking these resources to determine whether they have lots that are impacted by this extension. Moderna vaccine should not be disposed of until an accurate expiration date is assessed.

Providers who have vaccines that are unexpired under the extension should update their outbreak inventory in the Michigan Care Improvement Registry (MCIR) with a new expiration date, following the instructions on the tip sheet How to Correct a COVID-19 Vaccine Expiration Date in the MCIR. Questions about the extension or the MCIR process can be directed to the MDHHS Division of Immunization team. Members with other vaccine-related questions may contact Ruthanne Sudderth at the MHA.

Merck Requests FDA Approval for COVID-19 Treatment Pill

Merck formally requested approval from the U.S. Food and Drug Administration (FDA) Oct. 13 for a groundbreaking antiviral medication that effectively treats COVID-19. Trials demonstrate the treatment regimen, which comes in pill form that patients can take themselves at home, reduced risk of hospitalization and severe illness by at least 50%.

Approval would add a new effective treatment to providers’ toolboxes in keeping patients with COVID-19 out of the hospital. Unlike currently available antibody treatments that require providers to set up and staff infusion clinics, the pill could help provide relief to providers struggling with staffing and other treatment resources. If approved, the MHA will advocate that all payers, both public and private, cover the drug for all covered lives.

The MHA will keep members apprised of developments on this issue.

CDC Releases Planning Information for Vaccinating 5- to 11-year-olds

The Centers for Disease Control and Prevention (CDC) recently issued an initial planning document for jurisdictions to prepare for the distribution of vaccines for children ages 5 to 11. The document provides initial information pertaining to pediatric COVID-19 vaccines, as well as several assumptions that can be made about the pediatric COVID-19 vaccination program. Specifically, the document highlights the packaging changes and storage requirements for the Pfizer pediatric COVID-19 vaccine for kids ages 5 to 11. The Pfizer vaccine for this age group is currently under review at the FDA, and a decision on whether an emergency use authorization (EUA) for the product will be granted is expected in the coming weeks.

Ordering of the Pfizer vaccine and any subsequent pediatric COVID-19 vaccines will begin when the FDA issues an EUA. Vaccine administration will begin once the CDC director makes a determination after reviewing recommendations from the Advisory Committee on Immunization Practices. The MHA will keep members apprised of developments on the vaccine for younger children. Members with questions may contact Ruthanne Sudderth at the MHA.

U.S. Homeland Security & Governmental Affairs Committee Requests Provider Input

Sen. Gary Peters (D-MI), chairman of the Committee on Homeland Security & Governmental Affairs, and the committee’s ranking member Sen. Rob Portman (R-OH) are seeking firsthand accounts from individuals and organizations (healthcare providers, state and local governments, first responders, etc.) who experienced challenges securing personal protective equipment and other medical products during the early months of the COVID-19 pandemic. Currently, the committee request is open-ended.

This is part of the committee’s ongoing oversight of federal pandemic preparedness and the COVID-19 response. The committee will examine reports of fraud, exploitation, and faulty equipment and medical supplies. To this end, providers can report issues about vendors, counterfeit medical products, price-gouging or other challenges obtaining supplies during the response. The information received will help inform the senators’ bipartisan oversight and efforts to strengthen U.S. medical supply chains, improve emergency preparedness, highlight new and successful supply chain methods, and prevent bad actors from taking advantage of future national crises. Members interested in submitting their experiences can do so online.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpageQuestions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of May 3

MHA Covid-19 update

MHA Coronavirus UpdateAs of May 6, more than 7.2 million doses of COVID-19 vaccine have been administered in Michigan, and more than 51% of Michigan adults have received at least one dose of a vaccine. The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Pediatric, Primary Care Providers Should Prepare to Give Adolescent Vaccinations

The Food and Drug Administration (FDA) is expected to issue an emergency use authorization (EUA) to administer the Pfizer vaccine to children ages 12-15 as early as the week of May 10. Pediatric and primary care settings that wish to participate in the vaccine program are encouraged to enroll as soon as possible to ensure they are prepared to appropriately receive, store, track and administer vaccines for adolescents.

In response to this impending expansion, the Michigan Department of Health and Human Services (MDHHS) announced it has designated “Pfizer Regional Hubs” across the state to support efforts to make the vaccine available to 12- to 15-year-olds. These local health departments will maintain stock of Pfizer vaccine to share with COVID-19 vaccine providers that can manage it appropriately. Hospitals that need the Pfizer vaccine to offer to Michiganders ages 12 through 17 may request a supply from the Immunization Action Plan Coordinator at these hubs, which include:

  1. Grand Traverse Health Department
  2. Ingham County Health Department
  3. Kalamazoo Health Department
  4. Kent County Health Department (Fuller)
  5. Marquette Health Department
  6. Oakland Health Division
  7. Saginaw County Health Department
  8. Sanilac County Health Department
  9. Wayne County Health Department

It is the requestor’s responsibility to contact the regional hub to assess vaccine availability and to perform appropriate transport of vaccine for redistribution. Contact information for all local health departments is available online. The requestor is also responsible for ensuring the site is enrolled as a Michigan COVID-19 Vaccination Provider; has a redistribution agreement in place with the regional hub; and can meet all requirements for vaccine transport, storage, handling and documentation.

The MHA will keep members apprised of developments on the expansion of the Pfizer vaccine EUA. Vaccine-related questions may be directed to Ruthanne Sudderth at the MHA.

Medicare Payments Increased for mAb Therapies

The Centers for Medicare & Medicaid Services (CMS) recently announced an increase in the Medicare payment rate for administering monoclonal antibody (mAb) treatment to COVID-19 patients, effective May 6. The payment rate will increase 45%, from $310 to $450, for most healthcare settings. The CMS will also establish a $750 payment rate for this service when administered in the patient’s home or other temporary residence. Patients will incur no out-of-pocket cost for these services. Members with questions about these payments may contact Jason Jorkasky at the MHA.

A recording of a recent webinar explaining the operational processes required to provide mAb therapy is available online. Cohosted by the MHA and the MDHHS, the hour-long webinar reviewed a variety of resources for providers interested in providing the treatments. To receive copies of these documents, contact Laura Appel at the MHA.

Pfizer, Moderna Seek Full FDA Approval of Their COVID-19 Vaccines

Pfizer has asked the FDA for full approval of its COVID-19 vaccine for people ages 16 and over, which would allow the manufacturer to market the vaccine directly to the public. Pfizer is now studying the vaccine in children as young as 6 months and has said it expects more results from these studies by September.

According to news reports, Pfizer has shared data with the FDA about the vaccine’s long-term effectiveness and possible changes in handling requirements, such as evidence that the vaccine can be refrigerated for longer periods, rather than requiring ultra-cold storage temperatures.

Moderna has also requested full FDA approval of its vaccine, which is currently approved for ages 18 and older. It is currently studying the vaccine in 12- to 17-year-olds. In addition, Moderna has shared promising updates from its study of a booster of its vaccine to help prevent some of the most contagious variants of the virus.

While FDA approval reviews typically take six months or more, the agency could act quickly on approving the vaccines, since they had already received emergency authorization. The MHA will keep members apprised of this issue as it develops. For more information on vaccines, contact Ruthanne Sudderth at the MHA.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of April 26

MHA Covid-19 update

Gov. Gretchen Whitmer announced during an April 29 news conference that future epidemic order actions will be based on four vaccination-based milestones that will enable the state of Michigan to return to normalcy. Dubbed the “MI Vacc to Normal” challenge, the program’s goal is to reach a point where 70% of adults in the state are vaccinated and broad mitigation measures are lifted unless unanticipated circumstances arise. Meanwhile, Michigan’s hospitalization rates, testing positivity rates and other important measures are improving, although relatively high levels of acuity and pediatric admissions continue to cause high levels of stress on hospital staff and resources.

The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Administration of Johnson & Johnson Vaccine Resumes

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (CDC ACIP) voted April 23 to recommend that providers resume vaccinations using the Johnson & Johnson (J&J) single-dose COVID-19 vaccine for anyone 18 and older. The CDC issued an updated Morbidity and Mortality Weekly Report April 27 providing the most recent recommendations for use of the J&J vaccine. The Michigan Department of Health and Human Services (MDHHS) also issued an alert advising providers to resume use of the vaccine.

The J&J vaccine was placed on a pause April 13 while experts conducted a thorough safety review after reports of a rare blood clotting syndrome in some people. The CDC and the Food and Drug Administration (FDA) confirmed that 15 cases of the blood clots have been reported to the Vaccine Adverse Reporting System, including the six cases originally reported, and that all occurred in women between the ages of 18 and 59. Due to the unique treatment required for these adverse events, the agencies also ensured providers and clinicians were made aware of their potential and could properly recognize and manage them. Shipments of the J&J vaccine are scheduled to resume during the week of May 3.

Both the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers have been revised to include information about the risk of the blood clotting syndrome and should be reviewed prior to administration of the J&J vaccine.

CDC and MDHHS Provide Updated Vaccine Information

The CDC has issued updated interim clinical considerations for COVID-19 vaccines authorized for use in the United States. Providers are encouraged to review these considerations, as they cover such topics as interchangeability of vaccines, people vaccinated outside the U.S., antiviral therapy and vaccination, vaccination of pregnant or lactating individuals, and much more.

In addition, the MDHHS issued an alert on several updates to Moderna vaccines, including vaccine vial fill volume, updated labeling, and storage and handling modifications.

A recent emergency use authorization (EUA) revision indicates the Moderna vaccine will be available in two different vials by early May. Shipments of the new vials could occur as early as May 3, including the current maximum 11-dose vial and a new maximum 15-dose vial. Details about these new vials and packaging are available in the updated Moderna EUA fact sheet for providers.

Updated guidance for storage and handling of the Moderna COVID-19 vaccine have also been issued that include changes to time frames. The MDHHS clarified vaccine temperatures and storage time frames with the manufacturer, and an updated storage and handling summary and preparation/administration Moderna documents are available online.

Share Children’s Hospital Clinical Collaborative Open Letter on MIS-C

Leaders from a group of children’s hospitals and hospitals with extensive pediatric care programs together penned an open letter to clinicians and families across Michigan to raise awareness of multisystem inflammatory syndrome in children (MIS-C) as the spring surge continues to recede. These clinicians warn that Michigan could see children across the state experiencing MIS-C symptoms two to five weeks following the surge’s peak as children are exposed to the virus.

The letter offers details of the symptoms to be aware of, when to seek medical care, and links to appropriate treatment guidelines for clinicians. The MHA is distributing this letter on behalf of this group of pediatric clinical leaders from across the state and thanks them for their leadership around this critical issue.

Member hospitals and health systems are encouraged to distribute this letter to their physicians and ambulatory or primary care practices. The association will also share it on its social media channels to promote greater awareness among Michigan residents, especially families with children.

Members with questions may contact Laura Appel at the MHA.

Recording Vaccines on Michigan Care Improvement Registry is Important Step

Because increasing numbers of patients are seeking second doses at providers other than the one that provided their first dose, members are encouraged to review the proper procedures for looking up and recording vaccinations in the Michigan Care Improvement Registry (MCIR). The MDHHS has shared that it is receiving growing numbers of incorrect or duplicate vaccination records and wants to ensure an accurate reporting of the populations that have been vaccinated. Several detailed training guides are available online that vaccination teams can review at their convenience.

When patients present without their COVID-19 vaccine card, vaccination providers are urged to check MCIR to confirm the date and brand of their first dose to avoid medication errors that impact the effectiveness of the vaccine and other issues. Patients should also be encouraged to keep their vaccine card in a safe place and take a photo of it in the event it is misplaced.

Vaccinating Those Who Have Recovered from COVID-19

Although previous guidance recommended waiting 90 days before administering a vaccine to someone who recently had COVID-19, providers are now advised to vaccinate patients as soon as their symptoms have subsided and they are well enough to receive a shot. The change is due to the vaccine no longer being in limited supply.

However, patients who received monoclonal antibody (mAb) treatments for COVID-19 should not be vaccinated until 90 days after treatment, per CDC and MDHHS recommendations. It is not yet known how effective vaccines are in those who have previously received an antibody treatment for a COVID-19 infection or whether the antibody treatment could interfere with the body’s immune response to a vaccine.

The MHA recently cohosted a webinar with the MDHHS on mAb therapies and how to execute a successful mAb therapeutics clinic. A recording of the webinar is available online for those who were unable to participate.

Vaccination Rates Declining

As of May 1, more than 6.9 million doses of COVID-19 vaccine had been administered in Michigan, resulting in more than 4 million Michiganders having received at least one dose and more than 3 million getting all recommended doses of vaccine. Nearly 50% of adult residents have received at least one dose. However, the number of vaccinations administered in Michigan in the last week has dropped significantly, and supply has outpaced demand for the vaccines.

Because Black and Hispanic residents are being vaccinated at a slower pace than white Michiganders, the Protect Michigan Commission continues to make vaccine equity a high priority and has engaged partners to assist with doing door-to-door sign-ups, education and more. MHA members that are working with community partners are encouraged to ensure some of those partners are focused on reaching people of different races, ethnicities and cultures where they are in their communities.

Members with questions regarding vaccines should contact Ruthanne Sudderth at the MHA.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Feb 1

MHA Covid-19 update

MHA Coronavirus UpdateThe MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

State Changes Hospitals’ Share of Vaccines Distributed

The Michigan Department of Health and Human Services (MDHHS) has adjusted the number of COVID-19 vaccine doses available to each type of vaccination provider.

Although the MDHHS considered shifting to an allocation model of 70% of vaccines going to health departments and 30% going to hospitals, the department confirmed Feb. 4 that it will continue the allocation process it implemented the week of Feb. 1, with 60% of the available vaccine going to health departments and 40% to hospitals, until further notice. The MHA and members have advocated against moving a large allocation away from hospitals, which have administered more than a half million doses to Michigan residents. The MHA will also continue to identify and assist the MDHHS in using the most equitable sources of data to determine vaccine allocations. Member hospitals are encouraged to build partnerships with their local health departments to share resources and vaccine allocations to best serve their communities.

The MDHHS has developed a weekly survey for hospitals and health departments to guide the department’s decision-making on vaccine issues. The survey requests information about COVID-19 vaccine events hosted in the past week, the eligible populations the events targeted, where they were held and more. The hospital survey will be distributed each Friday, and responses to the first survey are due by 5 p.m. Feb. 8. If possible, the survey should be completed for individual facilities rather than at the health system level.

Members who would like assistance in fostering relationships with their local health department, have questions on the new vaccine survey or would like more information on the COVID-19 vaccine should contact Ruthanne Sudderth at the MHA.

FDA Considers EUA for New Vaccine, Revises Authorization for Convalescent Plasma

Johnson & Johnson subsidiary Janssen Biotech has requested emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its COVID-19 vaccine. If approved, the vaccine will be the first single-dose immunization available to fight the pandemic.

The FDA is scheduled to meet Feb. 26 to discuss the EUA request for this vaccine, which trials have shown to be 66% effective in preventing overall moderate to severe COVID-19. The company said the vaccine demonstrated complete protection against COVID-19 serious enough to require hospitalization and was 85% effective in preventing severe forms of the disease.

This vaccine also presents far fewer logistical and cold chain challenges than the Pfizer and Moderna vaccines, as it is estimated to remain stable for two years at minus four degrees Fahrenheit (minus 20 degrees Celsius) and can be stored for three months under standard refrigeration at 36 to 46 degrees Fahrenheit (two to eight degrees Celsius). Johnson & Johnson initially will provide 2 million doses to the U.S., followed by 100 million doses by midyear.

In addition, the FDA recently updated its EUA for convalescent plasma as a COVID-19 treatment. The revision reflects new data regarding the treatment’s efficacy and application and has been included in the agency’s provider fact sheet.

The new EUA for COVID-19 convalescent plasma limits the authorization to the use of plasma with a high concentration of antibodies for the disease, known as “high titer” COVID-19 convalescent plasma. It is authorized only for the treatment of hospitalized patients with COVID-19 early in the disease course and those hospitalized patients whose bodies cannot produce an adequate antibody response. According to the latest data, plasma with low levels of antibodies has not been shown to be helpful in COVID-19. Therefore, low titer COVID-19 convalescent plasma is no longer authorized under the EUA.

Monoclonal Antibody Treatment Encouraged; Mi-COVID19 Initiative Webinar to Discuss

The educational webinar series from the Mi-COVID19 Initiative will continue from noon to 1 p.m. Feb. 10 on the topic Approach to Monoclonal Antibody Treatment. Speakers include Dr. William Fales from the MDHHS and Drs. Tejal Gandhi and Lindsay Petty from Michigan Medicine. Registration is available online, as are recordings from previous events in this series.

Members are encouraged to use monoclonal antibodies as eligible cases of COVID-19 present in their facilities and to consider posting information on the COVID-19 sections of their organizations’ websites for interested and possibly eligible patients. The MDHHS recently issued a letter with information on this type of treatment and sends weekly alerts from the Michigan Health Alert Network about how to request a supply of the antibodies. Members with questions may contact Rob Wood.

Epic Scheduling Loophole Under Investigation

Beaumont Health announced Feb. 1 that an individual had used unauthorized “backdoor” access to Beaumont Health’s Epic patient portal to schedule a COVID-19 vaccine appointment, then shared the pathway publicly. The breach resulted in more than 2,700 unauthorized appointments being made, all of which have now been canceled. Beaumont Health shared the information to help other hospitals ensure a similar issue does not occur in their systems. The health system has contacted Epic and is working to safeguard the system against future unauthorized accessibility. No medical records were compromised due to the incident, and no valid vaccine appointments were affected. Members with questions or concerns about their Epic platform may contact Jim Lee at the MHA.

Moderna Vaccine Doses Thought to be Compromised are Deemed Viable

The Centers for Disease Control and Prevention has notified the MDHHS that Moderna vaccine shipped to Michigan in mid-January and thought to be ruined by a temperature excursion have been determined to be viable and can be used to vaccinate residents. McKesson Corp., which is responsible for shipping the vaccine, completed an internal investigation and determined the cause and lower limit of the cold excursion in these shipments. Based on data provided as part of that investigation, Moderna agreed that the vaccine in this shipment was viable upon arrival and remains viable under either of the following circumstances:

  • Doses are confirmed to have been stored in quarantine at -20C.
  • Doses are confirmed to have been stored in quarantine at 2-8C and the doses were placed in refrigerated storage within 30 days.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

 

Combating the Novel Coronavirus (COVID-19): Dec. 21 through Jan. 8

MHA Covid-19 update

MHA COVID-19 UpdateDuring the holiday season and into the new year, activity has continued related to the novel coronavirus and vaccines to protect against it, including the emergency use authorization and subsequent distribution of the Moderna vaccine. The MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Legislation, Policies Enacted to Fight COVID-19

The Michigan Department of Health and Human Services (MDHHS) announced Jan. 6 that additional Michiganders can be vaccinated against COVID-19 beginning Jan. 11, including residents 65 and over; police officers, first responders, front-line state and federal workers and jail and prison staff; and pre-K-12 teachers and childcare providers. The MHA issued a media statement following the announcement.

Joneigh Khaldun, MD, the state’s chief medical executive, advised that seniors and essential workers should contact their local health department (LHD) to seek an appointment for the vaccine. Hospitals that have operational capacity and enough vaccine to vaccinate seniors are encouraged to do so, as many LHDs lack the capacity to serve this large population. The MHA advises all hospitals to issue local media/social media information making clear whether they will vaccinate seniors and essential workers and any details on how to make an appointment to receive the vaccine.

In a Jan. 8 news conference, Gov. Gretchen Whitmer announced that her administration would like all Michigan K-12 schools to prepare to offer in-person learning on or before March 1. A rationale document was issued as part of the announcement, which includes explanations of the risks and safety of in-person learning, impact on those kept at home and their parents/guardians, and more. Members should be aware of this policy change as it may positively impact staffing challenges.

The governor signed Senate Bill (SB) 748 Dec. 30, providing supplemental appropriations for various priorities. While the governor vetoed some items, the MHA’s priorities on healthcare funding were approved. The items the governor and Legislature agreed upon included $10 million to reimburse Michigan hospitals for temporary staffing needs during COVID-19, $17 million to reimburse hospitals for the high cost of remdesivir treatments for patients, and $3.3 million to reimburse hospitals for holding and caring for nursing home patients beyond when they need hospital care. The MHA will work with policymakers as these funding items are implemented and keep members informed on how they may access these reimbursements.

The governor also signed into law two bills the MHA supported and advocated for during the legislative lame-duck session. SB 1258 amended Public Act 238 of 2020 to provide additional flexibilities regarding updated federal guidelines on timing for COVID-19-positive employees and potential exposures. The MHA will continue to seek further clarification from the MDHHS regarding similarities between COVID-19 symptoms and vaccine side effects. SB 1021 makes permanent in state law the flexibilities that allow Canadian health professionals to practice in Michigan.

The period for the governor to sign several bills reforming Michigan’s Certificate of Need (CON) process expired Jan. 6, effectively vetoing the bills. The legislation included several reforms that would have increased covered capital expenditures from $3.3 million to $10 million, added two members to the commission, and removed air ambulance as a covered service in June 2021. The MHA took a neutral position on an additional provision that was vetoed, which would have removed inpatient psychiatric services from CON in counties with populations less than 40,000. Members with questions on state legislation should contact Adam Carlson at the MHA.

Vaccine Distribution Updates

Vials of the Pfizer vaccine often contain a sixth dose that can be used to protect against COVID-19. However, the initial supply kits provided with the vaccine contained only five needles, which has caused some hospitals to experience needle shortages. The American Hospital Association has advised Operation Warp Speed (OWS) officials of these shortages, and OWS plans to increase the number of needles, syringes and other supplies in the kits to correspond with the available dosages in the vials. Members experiencing vaccine supply kit shortages should contact Adam Carlson at the MHA for assistance.

In an apparent response to a letter from the governors of eight states, including Michigan, the transition team for President-elect Joe Biden said it plans to release to states most of the COVID-19 vaccine being held by the federal government once Biden’s administration is in place after Jan. 20. The current stance of the U.S. Department of Health and Human Services and the Centers for Disease Control & Prevention is to hold back 50% of all vaccine supply to later ship second doses to providers. The Biden team states that it will work with manufacturers to ensure second doses are available for Americans. The MHA will work with its state and federal partners and elected officials to identify how this will affect hospitals’ vaccine allotments in Michigan and procedures for ordering doses. The association will provide updates as it obtains more information.

The MDHHS recently indicated that hospitals wishing to set up vaccine clinics at external venues need to follow the guidelines of the Centers for Disease Control and Prevention for quality assurance, storage, electrical, etc. Hospitals do not need to submit COVID-19 vaccine provider enrollment applications for sites that afford space to run mass vaccination efforts, such as hospital-owned/affiliated parking lots or properties or community-based venues. Any off-site clinic should provide guidelines that allow hospitals to do the required data entry, maintain cold storage and prevent wasted vaccine.

The MHA is working with the state and other partners to help hospitals overcome barriers and use opportunities in the vaccination process. To support those advocacy efforts, members are urged to complete a five-minute vaccine barrier survey by 5 p.m. Jan 11. Each hospital’s vaccine coordinator who leads the organization’s COVID-19 vaccine efforts should complete the survey.

The MHA is working daily with state officials to improve vaccine communication, information, transparency, coordination of roles and more. In addition, the association will work more closely with the Michigan Association for Local Public Health to ensure information is consistent across all health departments and hospitals/health systems. Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC). Members with MHA-specific questions should contact the following MHA staff members:

Combating the Novel Coronavirus (COVID-19): Week of Dec. 14

MHA Covid-19 update

As hospitals across Michigan and the nation begin vaccinating their personnel against COVID-19, the MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Hospitals Immunizing Staff Against COVID-19

Pfizer began shipping its COVID-19 vaccine from its global warehouse in Michigan Dec. 14 and continued to deliver it to hospitals across the country throughout the week. Healthcare providers began inoculating staff members soon after the vaccine arrived. The MHA joined Gov. Gretchen Whitmer and the Michigan Department of Health and Human Services (MDHHS) in recognizing the start of this significant step and thanking healthcare workers for being first in line to receive the vaccine.

As the Pfizer vaccine was being delivered to hospitals, the Food and Drug Administration continued its process toward of evaluating the Moderna vaccine. The second vaccine was approved for emergency use the evening of Dec. 18, and initial shipments to hospitals began Dec. 20. Inoculations with the new vaccine could begin as soon as Dec. 21.

However, the MHA and its members were disappointed to learn that the U.S. Department of Health and Human Services (HHS) will reduce the originally announced allocations of the Pfizer vaccine to many states, including Michigan, during its second week of distribution. The MHA issued a media statement Dec. 18 relaying the negative impact of the delay on Michigan hospitals and will continue to seek more timely and accurate information from the HHS, as well as additional vaccine.

The MDHHS clarified Dec. 18 that hospitals will be able to request both Pfizer and Moderna vaccine. The state will continue to send weekly surveys to hospitals to determine the amount of vaccine needed the following week, which will allow hospitals to request both types of vaccine. The MHA has created a side-by-side comparison of some of the key storage, shipment and administration features of the Pfizer and Moderna vaccines, and the state will continue to post updated resources and tools on its provider education webpage, as well as additional details on its provider information document. The CDC has posted a webpage with tools and information on the Pfizer product, including interim clinical considerations. A key CDC recommendation is that the vaccine be administered alone and that providers allow 14 days between administering this vaccine and other vaccines.

While the vaccinations are widely seen as the beginning of the end of the pandemic, it will take time to inoculate everyone who wants a vaccine. Michiganders are urged to continue to mask up, practice social distancing, get their flu shots and practice hand hygiene as they await their opportunity to be vaccinated. The state provides a COVID-19 Vaccine Dashboard with information about how many providers in each county are enrolled in the vaccine program, where shipments have gone and more, with a time delay of about 24 hours.

Members with questions on matters relating to COVID-19 vaccines should contact Ruthanne Sudderth at the MHA.

Congress Agrees on National COVID-19 Relief Package

News outlets reported the evening of Dec. 20 that congressional leaders had reached bipartisan agreement on providing financial relief to U.S. residents and businesses struggling due to the pandemic, including making grants available to healthcare providers. The legislative text was still being crafted that night, and voting is expected to take place Dec. 21.

MHA Requests Order Allowing HCP Experiencing Vaccine Side Effects to Work

The MHA sent a letter Dec. 17 to MDHHS Director Robert Gordon and Chief Medical Executive Joneigh Khaldun, MD, urging them to issue an order that ensures healthcare personnel (HCP) who recently received COVID-19 vaccines are not unnecessarily removed from the workforce because of vaccine side effects that mimic COVID-19 infection. The letter requested the order exclude known vaccine side effects from the definition of COVID-19 symptoms Public Act (PA) 238 of 2020, which requires that employees displaying the principle symptoms of COVID-19 not report to work until 10 days after the principal symptoms of COVID-19 first appeared. The principle symptoms of COVID-19 include known side effects of both the Pfizer and Moderna vaccines. PA 238 further gives the director or chief medical executive of the MDHHS the power to issue an order modifying the definition of COVID-19 symptoms. The MHA noted that, without an order from the MDHHS exempting symptoms from a known vaccine administration, there could be unnecessary staff absences due to the inoculations.

The MHA encouraged the state to consider recently issued official CDC guidance on handling HCP who have received COVID-19 vaccines and experience mild side effects as it makes decisions on this issue. The CDC guidance urges healthcare facilities to evaluate any personnel who have symptoms but recently received vaccine and allow HCP to continue working as appropriate, depending on the nature and severity of the symptoms. This guidance applies only to symptoms such as fever and fatigue and not to those that are not known side effects of the vaccines, such as cough and loss of taste/smell.

MDHHS Order Relaxed but Extended to Jan. 15

The MDHHS announced Dec. 18 that it is extending to Jan. 15 a public health order that will keep restaurants and bars closed to indoor dining, but will reopen many other indoor venues where patrons can wear masks while inside. The governor and the MDHHS indicated the orders that have been in place since November have contributed to an improvement in Michigan’s COVID-19 year-end surge.

The new order reopens in-person learning at high schools and indoor entertainment venues. Casinos, bowling centers and movie theatres will be allowed to reopen with total capacity capped at 100; food and drink concessions closed; and social distancing requirements in place. The order takes effect Dec. 21.

OBRA Electronic System Again Delayed

The MDHHS Office of Specialized Nursing Home/Omnibus Budget Reconciliation Act (OBRA) Programs recently announced an additional delay in changing the submission of forms 3877 and 3878 from a paper process to an electronic one. The “go live” implementation date of the online system has been delayed from Jan. 19 to at least April 2021 (see related article).

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC). Members with MHA-specific questions should contact the following MHA staff members:

Vaccine Information is Developing Rapidly

The MHA and other stakeholder organizations are prepared to promote events to vaccinate community members against the flu, helping ensure that residents are fully aware of their availability. MHA members that will host or participate in flu vaccine events/clinics are encouraged to share the event details to allow the MHA and interested partners to boost their visibility.

Meanwhile, the MHA and its members have been in frequent contact with the Michigan Department of Health and Human Services (MDHHS) on issues related to COVID-19 vaccines. The Food and Drug Administration (FDA) is expected to soon issue emergency use authorizations (EUAs) for vaccines developed by drug companies Pfizer and Moderna.

The MDHHS has provided updates on COVID-19 vaccines based on the Dec. 1 meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and updated CDC documents. Members are encouraged to review the documents, which will be updated as vaccine information becomes available, for guidance on staff education, storage, data reporting and more. In addition, members should monitor the frequent vaccine updates available in the CDC’s vaccine storage and handling toolkit.

The ACIP recommended that healthcare personnel and long-term care facility (LTCF) residents be included in priority group 1a for vaccination, and this will be considered as Michigan finalizes state priority groups. LTCF residents and LTCF healthcare workers will be vaccinated by LTCF pharmacy partners (largely CVS Health and Walgreens).

The number of vaccine doses that will be shipped has not been finalized. The state is working to ensure that distribution of vaccine to health systems and hospitals is as equitable as possible based on number of employees and storage capacity. The earliest tentative shipping dates are Dec. 15 for the Pfizer vaccine and Dec. 22 for the Moderna preparation. These dates could change based on the timing of the FDA and ACIP final approvals. Initial shipments should be used to administer first doses of the vaccines; facilities will receive second doses for those individuals in separate shipments that will arrive prior to the recommended vaccine administration “gaps” of 21 days for the Pfizer injections and 28 days for the Moderna shot. Hospitals that have vaccine-eligible employees who work in Michigan facilities but reside in another state may receive their vaccine at the Michigan-based hospital.

The MHA is preparing a frequently asked questions document that will answer questions about the vaccines, and additional tools for use in education, responding to the media, and more will be provided in the coming weeks.

For insurance billing purposes, current procedural terminology (CPT) codes have been issued for COVID-19 vaccines that will take effect after the FDA has issued EUAs for the vaccines. Providers may not deny any recipient the vaccine due to their coverage status or ability to pay, and recipients may not be balance billed. Additional coverage details are available from the Centers for Medicare & Medicaid Services.

Vaccine recipients must be given information on what vaccine they received, when the second dose is due, and details about the vaccine and potential side effects. In addition, vaccine administration data must be entered into the Michigan Care Improvement Registry (MCIR) within 24 hours of being given to the recipient, including weekends and holidays.

To assist in ensuring residents receive the necessary second dose of the vaccines, MCIR plans to launch a text service to issue reminders to vaccine recipients. However, providers are encouraged to use their electronic health record systems or other means of reminding patients of their second dose of COVID-19 vaccine.

The MHA will continue to meet regularly with MDHHS immunization leaders to share hospital questions/concerns, receive planning updates and more. The association will keep members apprised of new information as it is received. Members with questions regarding vaccines should contact Ruthanne Sudderth at the MHA.

Combating the Novel Coronavirus (COVID-19): Week of Nov. 16

MHA Covid-19 update

MHA COVID-19 UpdateAs the Thanksgiving holiday approaches, the number of hospitalizations due to COVID-19 continues to rise. The MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Vaccine Studies Show 95% Effectiveness

Moderna announced Nov. 16 that the latest trials and studies of its COVID-19 vaccine show 95% effectiveness, and Pfizer updated its findings Nov. 18, announcing its vaccine also shows 95% effectiveness. Moderna’s results stem from its Phase 3 clinical trial of 30,000 individuals, and Pfizer’s efficacy rate resulted from a final analysis of its trial with more than 41,000 volunteers. Both vaccines use messenger RNA (mRNA) technology to cause the effective immune response. A key difference between the vaccines is that Moderna’s vaccine can be safely stored in freezers at about 25 degrees Fahrenheit (minus 4 degrees Celsius), a temperature easily reached by a normal freezer. The Pfizer vaccine requires ultracold storage only achieved by specialized freezers or dry ice.

Pfizer applied with the Food and Drug Administration for emergency use authorization of its vaccine Nov. 20, and Moderna expects to soon apply for the authorization. Although distribution dates are not yet certain, the Michigan Department of Health and Human Services (MDHHS) has advised that providers should be prepared to accept vaccine by early December to ensure expedient distribution and administration when shipments begin. Members with questions may contact Ruthanne Sudderth at the MHA.

Provider Relief Fund Further Clarified

The U.S. Department of Health and Human Services (HHS) has issued two important clarifications related to Provider Relief Fund (PRF) reporting.

The HHS had previously stated that providers could claim only the value of depreciation for COVID-19-related capital purchases with useful lives of more than 12 months. However, after urging from the American Hospital Association and the MHA, the agency stated that expenses for capital equipment, facilities projects and inventory may be fully expensed in cases where the purchase was directly related to the prevention, preparation for and response to COVID-19. Examples of such purchases include:

  • Upgrading heating, ventilation and air conditioning systems to support negative pressure units.
  • Retrofitting COVID-19 units.
  • Enhancing or reconfiguring intensive care unit capabilities.
  • Leasing or purchasing temporary structures to screen and/or treat patients.
  • Leasing permanent facilities to increase hospital capacity.

The HHS also clarified that providers’ reporting of net patient revenue should NOT include payments received from or made to third parties that relate to care not provided in 2019 or 2020.

For more information on the PRF, contact Jason Jorkasky at the MHA.

COVID-19 ICU Best Practices Follow-Up Webinar Offered Nov. 24

A Nov. 11 COVID-19 webinar titled “ICU Management & Treatment of COVID-19 Patients” was hosted under the MI-COVID19 registry continuous quality improvement initiative and provided meaningful discussion for participants. As a result, a follow-up webinar has been scheduled for noon to 1 p.m. EST Nov. 24. Objectives include:

  • Summarizing the latest COVID-19 intensive care unit (ICU) guidelines and recommendations.
  • Discussing best practices for management of critically ill COVID-19 patients.
  • Identifying resources and creating a network for ICU leaders in Michigan to advance the care of critically ill COVID-19 patients.

Members may register online, and questions should be emailed to covid19clinicalsupport@umich.edu.

CDC Offers Education on Telehealth and Health Equity Dec. 8

The Centers for Disease Control and Prevention (CDC), through its Clinician Outreach and Communication Activity division, will host an educational event via Zoom from 2 to 3 p.m. EST Dec. 8 that will focus on telehealth and health equity. Details and access information for the event are available online. Presenters from Kaiser Permanente and the Veterans Health Administration will discuss how telehealth has affected health equity in their patient populations before and during the COVID-19 pandemic.

Topics will also include challenges and opportunities related to telehealth implementation. Presenters will share strategies to expand access that can reduce disparities and improve culturally responsive care to help achieve health equity within each organization. In addition, presenters from the CDC will share telehealth strategies that incorporate the CDC’s frameworks for Addressing Health Equity in Public Health Practice.

In associated news, the MHA recently released its Pledge to Address Racism and Health Inequities that was approved by the MHA Board of Trustees at its Nov. 4 meeting (see related article).

COVID-19 Relief Facility Application Now Open

The state has released the application for being designated a COVID-19 Relief (CR) Facility, which are designed to allow eligible Nursing Facilities to retain COVID-19-positive residents. These facilities will meet criteria established in Senate Bill 1094 to care for COVID-19-positive residents who become ill and do not require hospital-level care. The purpose of the CR Facilities is to provide care in place with enhanced infection control measures for individuals with confirmed COVID-19 who have not met the criteria for discontinuation of Transmission-Based Precautions and have limited access to the state’s Care and Recovery Centers. All approved CR Facilities may retain, or readmit after acute care, their own COVID-19-positive residents.

Facilities must meet certain criteria to qualify for CR Facility designation or admission of new COVID-19-positive residents, as detailed in Bulletin Number MSA 20-73 from the Medical Services Administration. The bulletin also provides a list of documents and details applicants should have prepared before applying.

Completed applications should be submitted by 5 p.m. Dec. 1. The MDHHS, in partnership with the Michigan Department of Licensing and Regulatory Affairs, will review applications as they are received. Notification of application status will be contingent upon the volume of applications received. However, it is estimated that facilities seeking CR Facility designation may expect to be notified about the determination within one to two weeks of application submission. Questions about CR Facilities may be submitted to the MDHHS via email.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC). Members with MHA-specific questions should contact the following MHA staff members: