As the number of new cases and hospitalizations due to COVID-19 begin to diminish in Michigan, both Pfizer and Moderna have launched trials for vaccines targeting the omicron variant of the coronavirus. The variant is estimated to make up 99% of the current cases in the United States.
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.
CMS Vaccine Requirement for Healthcare Workers Began Jan. 27
The Centers for Medicare & Medicaid Services (CMS) requirement that healthcare workers be vaccinated against COVID-19 took effect Jan. 27. Employees are required to have received a first dose by that date and a second dose — if getting a two-dose vaccine — by Feb. 28.
The Michigan Department of Health and Human Services (MDHHS) issued a letter to all providers detailing the requirements of the CMS rule and provided implementation tools for providers to execute the policy internally. These include FAQs, education materials and more. MHA members are encouraged to use these tools as necessary to comply with the mandate.
The state of Michigan held a press conference Jan. 11 to discuss the rapid rise in case numbers, hospitalizations (especially pediatric hospitalizations) and positivity rates. Speakers urged all residents who are eligible to be both vaccinated and boosted as quickly as possible. Representatives from Children’s Hospital of Michigan joined the event to discuss the concerning rise in childhood case rates and hospitalizations.
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.
The U.S. Supreme Court issued decisions Jan. 13 on the Centers for Medicare & Medicaid Services (CMS) and Occupational Safety and Health Administration (OSHA) vaccine mandates. As expected, the court blocked the Biden administration from enforcing the vaccine or test mandate issued under OSHA, but upheld the ability of the CMS to enforce the healthcare worker vaccine mandate.
The Supreme Court has repeatedly upheld the constitutionality of state vaccine mandates in a variety of settings, as well as mandates by private employers. These challenges were different because they presented the question of whether Congress had authorized the executive branch to institute the requirements through the agencies of OSHA and the CMS/Department of Health and Human Services.
Michigan was not one of the 26 states covered by the court injunction to the CMS mandate, and Michigan has no other state-issued prohibitions on enforcing federal or private vaccine mandates. Hence,the mandate and enforcement move forward. The currently posted deadline for completing the first required vaccine dose is Jan. 27, and the second dose is required by Feb. 28. Boosters are currently not part of the mandate.
The MHA responded to a number of media inquiries following the Supreme Court announcement, including from The Detroit News, Detroit Free Press and MiBiz. The association reiterated its long-standing position that mandates of this kind should be left up to local healthcare decision-makers and that hospitals and the MHA have always urged every resident who is eligible to get vaccinated to protect themselves and others. The MHA also stressed that, while the small number of hospital workers who have already ended their employment due to an organization’s mandate did not necessarily worsen the existing staffing shortages, the timing of a nationwide mandate amid this omicron surge could not be worse, as the shortages are more serious than ever. The association assured reporters that hospitals will proceed with compliance and that the MHA and its members will continue to strenuously advocate for staffing assistance from federal and state partners.
Members with questions about deadlines, enforcement or other elements of the mandate are encouraged to review the posted CMS guidance to ensure their organizations are prepared to comply.
MIOSHA: Hospitals May Currently Use CDC Quarantine Guidance Without Penalty
The MHA has continued to work with state regulators on securing updated guidance for hospitals and health systems as it relates to worker quarantine periods. Federal Occupational Safety and Health Administration (OSHA) rules have not yet been fully rescinded to allow for healthcare settings to confidently follow new, less restrictive Centers for Disease Control and Prevention (CDC) quarantine guidance.
However, the Michigan Occupational Safety and Health Administration (MIOSHA) has stated it was told OSHA is in the process of withdrawing the relevant rules and the state agency is preparing to update its rules to align with the revised federal rules. MIOSHA also indicated that, until updates are made at the federal and state levels, it will not issue citations specifically regarding quarantine and isolation requirements if an employer were following the Dec. 23, 2021, updated CDC guidance for healthcare personnel.
An existing OSHA provision recognizes the CDC’s ‘‘Strategies to Mitigate Healthcare Personnel Staffing Shortages.’’ This guidance allows elimination of quarantine for certain healthcare workers as a last resort if the workers’ absence would mean there are no longer enough staff to provide safe patient care, specific other amelioration strategies have already been tried, patients have been notified, and workers are using additional personal protective equipment at all times.
The MHA will continue to keep members apprised of developments on this issue. Members with questions may contact Laura Appel at the MHA.
Long-term Care Facility Capacity for COVID Care Increases
Michigan now has 50 Tier-2 COVID-19 Relief Facilities (CRFs) able to take COVID-19 patients from hospitals at discharge if their normal nursing facility isn’t able to accommodate them. This is an increase from just 27 CRFs late in 2021 and includes an Upper Peninsula facility in Hancock.
In addition, Michigan now has nine facilities designated as Care and Recovery Centers (CRC)s, including one in Escanaba in the Upper Peninsula.
The CRC and the CRF programs were established under Michigan Public Act 231 of 2020. These programs were designed to ensure Michigan’s nursing homes were prepared to provide care to individuals who have tested positive for coronavirus under transmission-based precautions within the guidelines and best practices from the Centers for Disease Control and Prevention. Michigan’s nursing homes must be reviewed by the Michigan Department of Health and Human Services (MDHHS) to ensure they meet the minimum criteria outlined within the legislation and associated MDHHS policies. Members with questions may contact Paige Fults at the MHA.
Red Cross Declares First Ever National Blood Supply Crisis
The American Red Cross declared a national blood supply shortage and operational crisis Jan. 10. This is the first time such a crisis has been declared, and it could impact hospitals’ ability to provide certain types of care or transfusions in the coming days and weeks. This is a result of the current COVID-19 surge causing canceled donation appointments, Red Cross staffing shortages and more.
The Red Cross chief medical officer sent a notification directly to hospital transfusion leaders outlining these operational challenges and how to plan for expected shortages. The Red Cross also urged the public to donate blood as soon as possible.
The MHA will be amplifying to the public the need for blood donors through its social and traditional media channels.
Michigan Sees Surge in Unemployment Fraud
Michigan has seen a recent surge in unemployment fraud claims, according to the MHA Unemployment Compensation Program (MHA UCP). The increase in unemployment fraud is related to identity theft that occurs when the state Unemployment Insurance Agency (UIA) system is penetrated. Over the past several weeks, the MHA UCP has seen fraud in about 15 to 20% of all new claims for its clients.
The MHA UCP has worked closely with the UIA on this issue and has mitigated the impact for clients, who have not been assessed charges on these claims. To learn more about the services available through the MHA UCP, contact Neil MacVicar at the MHA.
According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the omicron variant of COVID-19 is now the dominant strain across the U.S. The CDC’s model indicates that more than 95% of cases in the nation as of Jan. 1 may be due to omicron.
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.
President Announces Updated Testing and Military Personnel Strategy
President Joe Biden Dec. 21 announced the federal government will make 500 million at-home rapid tests available to Americans and will deploy roughly 1,000 military personnel to hospitals across the U.S. to help ease the stress the current COVID-19 surge has placed on providers.
The rapid tests will be free of charge and available via an online request form, after which they will be delivered to residents’ homes. The plan also includes opening new federal testing sites and sending out hundreds of federal vaccinators. These tactics will begin in January according to the White House fact sheet on this effort.
Members are encouraged to review the entire fact sheet, which discusses other elements of the plan, including the distribution of more ventilators, production increases for supplies, federal testing sites and more.
The MHA will keep members apprised as more information becomes available about what assistance will be directed to Michigan as a result of this announcement. Members with questions about federal actions may contact Laura Appel at the MHA.
Boosters Expanded to 12- to 15-year-olds; Waiting Period Shortened
The federal Food and Drug Administration (FDA) and the CDC have announced that children aged 12 to 15 may now receive booster doses of the Pfizer and Moderna COVID-19 vaccines.The agencies also approved a shortened waiting period from six months to five months to receive a booster following a primary series of either of the two vaccines. In addition, certain immunocompromised children aged 5 to 11 are eligible for a booster and may receive it 28 days after the completion of their initial series.
The two-month booster interval recommendation for people who received the Johnson & Johnson vaccine has not changed.
The FDA reached its decision after reportedly reviewing data from Israel, which included information on 6,300 people ages 12-15 who received a booster shot at least five months after their initial two-dose series. The data showed no new cases of two possible side effects that had been observed in some young people who received the vaccine — myocarditis and pericarditis.
Urge Senate to Support Healthcare Staffing Funds
The MHA issued an action alert before the holidays, urging all members to contact their state senators and ask that they support critical healthcare staffing funding, which passed the state House with bipartisan support in December. As lawmakers prepare to return to session the week of Jan. 10, it is important to continue advocacy efforts.
House Bill 5523 would appropriate $300 million for healthcare retention and recruitment, which could help hospitals and other providers navigate the serious worker shortages that currently exist amid a pandemic surge. The MHA Legislative Action Center provides key messages on this issue and contact information for senators. Members with questions may contact Adam Carlson at the MHA.
A full year after COVID-19 vaccines were made available in the U.S., the coronavirus continues to sicken and kill people, with nationwide deaths from the illness surpassing 800,000. As demonstrated in a collection of headlines, Michigan’s hospitals are being stretched to treat COVID-19 patients across the state.
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.
Legislation Signed to Delay Sequestration Cuts
President Joe Biden signed legislation Dec. 10 to stop Medicare cuts to hospitals, physicians and other providers from going into effect early next year. As urged by the MHA and the AHA, both the U.S. Senate and House recently voted to pass the legislation.
Specifically, the bill would extend the moratorium on the 2% Medicare sequester cuts until March 31, 2022, and reduce the cuts from 2% to 1% from April 1 through June 30, 2022. The package also would stop the 4% statutory Pay-As-You-Go sequester from taking effect early next year. Other provisions in the package would mitigate a separate Medicare payment cut to physicians; delay payment cuts and private payer data reporting requirements for certain hospital laboratories; and more (see related article). Members with questions may contact Laura Appel at the MHA.
The state Legislature completed work Dec. 14 on Senate Bill 759, which allows healthcare workers licensed in another state to work in Michigan during times of great need (see related article). The MHA issued a media statement both thanking legislators for their support of licensing flexibility and encouraging Gov. Gretchen Whitmer to sign the bill into law as soon as it’s enrolled.
Members with questions may contact Adam Carlson at the MHA.
State Approves Additional Tier-2 COVID Relief Facilities
Fifteen additional Tier-2 COVID Relief Facilities(CRFs) were recently approved by the state at a time when post-acute placements are critically needed.
Tier-2 CRFs can keep their own COVID-19-positive residents and are able to admit new residents who test positive only if additional capacity is needed and the nearest COVID Recovery Center (CRC) is more than 25 miles away or at maximum capacity with patients positive for the disease.
With the additional facilities, there are currently 27 CRFs in the state. While this is a positive development, the number is significantly lower than the more than 100 CRFs the state had approved before starting its annual renewal process in October. That process took nearly a month to approve the additional facilities. The MHA continues to advocate that the state not use an annual application process for approving CRFs due to the time involved and the delays it causes for hospital transfer.
In addition, Michigan currently has no Tier-2 CRFs north of Grayling. Therefore, the MHA isurging the state to work with facilities in the northern Lower Peninsula and Upper Peninsula to quickly approve them as CRFs. Members with questions may contact Paige Fults at the MHA.
Changes Continue with Legal Action on Vaccine Mandates
The U.S. Court of Appeals for the Fifth Circuit issued a ruling Dec. 15 ordering the Centers for Medicare & Medicaid Services (CMS) vaccine mandate rule to resume in about half of the country while saying 24 states are not subject to the mandate. This means that the mandate is back in place for Michigan, requiring healthcare workers to be fully vaccinated.However, the suspension of enforcement of the mandate continues.
The Fifth Circuit upheld the Louisiana district court’s preliminary injunction as applied to facilities in the 14 states that are plaintiffs in the case. An additional 10 states that are plaintiffs in a Missouri case do not need to comply with the mandate while the injunction stands. Michigan is not a plaintiff in either lawsuit.
The American Hospital Association (AHA) provides a blog with the latest details of the CMS vaccine mandate cases, as well as an update on an appeals court ruling challenging the Occupational Safety and Health Administration vaccine mandate.
The recent court actions are additional steps toward the suits eventually being appealed to the U.S. Supreme Court. These legal actions do not impact individual organizations’ vaccine policies. Members with questions should contact Amy Barkholz at the MHA.
The state’s coronavirus webpage indicates there were an average of 9,222 new COVID-19 cases per day Dec. 2 and 3, bleakly demonstrating the current surge of the disease in Michigan. However, 55.6% of Michiganders ages 5 and older were fully vaccinated as of Dec. 3, and more than 1.6 million residents had received booster shots as of that date.
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.
Collaborative Efforts Urge Public to Take Precautions, Get Vaccinated
As the omicron variant, the latest version of the evolving coronavirus, begins to appear in the United States, the MHA, its members and public health agencies are urging the public to be particularly mindful of precautions they can take to guard against infection.At this time, there is no evidence to indicate omicron is present in Michigan. However, the MHA will remain in close contact with the State Department of Laboratories as it sequences samples and will keep members apprised of any developments.
The Michigan Department of Health and Human Services (MDHHS) and the MHA issued a joint press release Dec. 2 using a new set of infographics developed by the association. These images show the percentages of vaccinated versus unvaccinated COVID-19 hospitalizations, those in ICUs and those on ventilators. The release urged the public to get vaccinated to not only protect their own health, but the health of healthcare workers and to avoid additional strain on the state’s healthcare systems.
MHA-member health systems provided the data for this effort. The release included the following messages:
Three out of four COVID-19 patients are unvaccinated (76%).
87% of COVID-19 ICU patients are unvaccinated.
88% of COVID-19 ventilator patients are unvaccinated.
Members are encouraged to share these figures along with their organizations’ local data to maintain the public’s awareness. Members with questions may contact Ruthanne Sudderth at the MHA.
In addition, the MHA published a consensus statement Nov. 22 to statewide media on behalf of the chief medical officers of its member hospitals urging the public to take action to help slow COVID-19 growth throughout the state and educate them about the serious nature of the current surge and hospital capacity issues. MHA members are encouraged to use this statement locally or use it as a template for an organization-specific update to their communities. This message has been widely broadcast throughout the state (see related article).
Members with questions about vaccines and COVID-19 precautions may contact Ruthanne Sudderth at the MHA.
CMS Delays Enforcement of Healthcare Worker Vaccine Mandate as Courts Issue Injunctions
Although Michigan was not impacted by the Nov. 29 preliminary injunction against enforcement of the Centers for Medicare & Medicaid Services (CMS) healthcare worker vaccine mandate in 10 states, a separate preliminary injunction issued Nov. 30 does affect Michigan by placing a hold on the mandate in all other states. The federal government has appealed each order to the U.S. Court of Appeals in their respective circuits and asked the appellate courts to set aside the district courts’ preliminary injunction pending appeal.
Subsequently, the CMS issued a memorandum Dec. 2 confirming that it will not enforce its vaccine mandate while the court orders are in effect. The memo states that the CMS has “suspended activities related to the implementation and enforcement of this rule pending future developments in the litigation.” It also states that “while these preliminary injunctions are in effect, surveyors must not survey providers for compliance with the requirements of the” mandate.
The document does not state what the CMS would do when and if the preliminary injunctions are removed, such as setting new compliance dates.
The federal mandates do not impact hospitals’ ability to implement their own organization-based staff vaccine requirements if they choose to adopt such a policy.
MHA members are encouraged to follow the American Hospital Association (AHA) blog authored by Sean Marotta, a partner at Hogan Lovells and outside counsel for the AHA. The blog will be updated regularly as new developments occur. The MHA will also keep members apprised of developments. Members with questions may contact Amy Barkholz at the MHA.
Medicaid Coverage Expands to Cover Authorized In-home COVID Test Kits
The MDHHS recently released concurrent proposed and final policies to expand Medicaid coverage of COVID-19 testing to include home testing kits authorized by the U.S. Food and Drug Administration when administered consistent with recommendations by the Centers for Disease Control and Prevention. The expanded coverage for dates of service on and after Aug. 30, 2021, is contingent upon approval by the CMS. Approved testing kits must be prescribed or ordered by a Medicaid-enrolled participating pharmacy. Coverage will continue through 15 months following the end of the federal public health emergency. Comments should be submitted by Jan. 4. Questions may be directed to Vickie Kunz at the MHA.
Michigan 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.
The number of Michiganders ages 16 and older who have received at least one dose of COVID-19 vaccine reached 69% Oct. 28, according to the state tracker. More than 59% of those ages 12 and up were fully vaccinated as of Oct. 26.
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.
Vaccine for Kids Aged 5-11
An independent panel of experts advising the U.S. Food and Drug Administration recently voted to recommend the Pfizer COVID-19 vaccine be used in children aged 5 to 11. The next and final steps before this vaccine can be administered is approval by the Centers for Disease Control and Prevention (CDC), whose experts are scheduled to meet and vote Nov. 2 and 3. Following their vote, swift action is expected by the CDC director to authorize administration of the vaccine in younger kids. Members are encouraged to watch for updates from the MHA, the state and federal agencies Nov. 3 for details and information about rolling out this vaccine. Members with questions may contact Ruthanne Sudderth at the MHA.
Patient/Provider COVID-19 Vaccine Testimonials, Stories Could Save Lives
As the MHA continues public communication efforts to increase the statewide COVID-19 vaccination rate, hospitals and health systems are encouraged to submit stories, quotes, photos and/or video testimonials from clinicians or patients who are willing to advocate for the COVID-19 vaccines. The use of such stories was encouraged by the MHA Board of Trustees to ensure effective messages reach as many vaccine-hesitant people as possible.
Submissions can include clinicians speaking to the safety and effectiveness of the vaccines, impactful patient stories (i.e., a change of heart regarding vaccination status) or links to existing media coverage that can be shared across social media. Content can be submitted through Google Form or sent directly to Lucy Ciaramitaro at the MHA. These stories and the organizations that submit them will be featured across all MHA communication vehicles to inspire people who are waiting to be vaccinated.
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.
CDC, FDA Approve Moderna and J&J Boosters, Mix and Match Strategy
The director of the Centers for Disease Control and Prevention (CDC) Oct. 21 formally endorsed the use of COVID-19 booster shots from Moderna and Johnson & Johnson (J&J) for some adults. This comes on the heels of the Oct. 20 approval from the Food and Drug Administration (FDA).
The actions authorize a Moderna booster for people 65 and older and for all adults who either have underlying conditions or work in settings where they’re more likely to be exposed to the virus. Those people may obtain the Moderna booster, which is half the size of each dose used for initial vaccination, six months after completing the primary vaccine series.
The agencies also recommended all adults who received the J&J single-shot vaccine get a booster at least two months post-immunization. In addition, the agencies agreed that people who are eligible can choose any type of booster, regardless of whether they initially received the Pfizer, Moderna or J&J version. This decision may help individuals who have a higher risk of side effects with a particular brand of vaccine.
Healthcare providers are encouraged to continue monitoring for email updates from the Michigan Department of Health and Human Services (MDHHS) and Health Alert Network for details regarding booster dose administration. The MDHHS has also posted updated fact sheets for the vaccines on its website for vaccinating providers.
The MHA continues to promote both factual and anecdotal messaging about the safety and effectiveness of COVID-19 vaccines. The association is also using messaging on flu vaccines, urging people to get vaccinated and practice smart preventive measures to help avoid “twindemic” status and add to the stress on the healthcare system.
Members with vaccine questions may contact Ruthanne Sudderth at the MHA.
MHA Urges Medicaid to Cover Merck COVID-19 Treatment Pill
The MHA submitted comments Oct. 18 to state Medical Services Administration officials, urging them to add molnupiravir, Merck’s new COVID-19 treatment pill, to the Medicaid Health Plan Common Formulary if it is approved by the FDA. The medication has been shown to effectively treat COVID-19 and reduce death and hospitalization. Importantly, it comes in pill form that the patient takes at home, unlike current antibody treatments that must be administered by health and hospital professionals, using time and resources that are currently scarce. The association will keep members apprised of the FDA’s review of the treatment and any action by the state to add it to the Common Formulary.
As 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 state. Seventy-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.
The number of Michiganders hospitalized with COVID-19 has continued to rise, with 1,811 adults and 35 children confirmed as inpatients Oct. 8. An additional 119 adults and six children were hospitalized with illnesses suspected to be COVID-19. Of that number, 485 adults were in intensive care units and 250 were ventilated.
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.
Pfizer Requests Emergency Use Authorization of COVID-19 Vaccine for Children Ages 5-11
Pfizer and BioNTech announced Oct. 7 that they have submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization in children ages 5-11. The FDA will review the evidence to determine whether the shots are safe and effective for this age group, and an independent expert panel will publicly debate the evidence Oct. 26. From that point, advisers to the Centers for Disease Control and Prevention (CDC) will make their recommendation, and the CDC will make a final decision. If regulators agree, shots could be available to the 5-11 age group within a matter of weeks.
The MHA will keep members informed as new details emerge. Those with vaccine questions may contact Ruthanne Sudderth at the MHA.
Nursing Care and Recovery Center Applications Re-opened
The Michigan Department of Health and Human Services (MDHHS) recently released a new policy bulletin to update regulations from November 2020 that allow COVID Relief Facilities and eligible nursing facilities to retain COVID-19-positive residents. Public Act (PA) 231 of 2020 established criteria under which nursing facilities could care for COVID-19-positive residents, with the statute put into effect through MSA Bulletins 20-73 and 20-78. Facilities designated as Care and Recovery Centers or COVID Relief Facilities will need to apply for that designation on a yearly basis.
Nursing facilities that had not applied for either designation before the Dec. 1, 2020, deadline may now apply if they wish to seek accreditation. Like the previous policy, nursing facilities that have applied for COVID Relief Facility designation but have not yet received approval/denial for participation may continue to care for individuals who have tested positive for COVID-19. Members with questions may contact Adam Carlson at the MHA.
Funding Available for Nursing Home Patients Awaiting Transfer
The MDHHS released a template in June to collect information from hospitals about the number of COVID-19-positive nursing facility patients who were retained by hospitals and had less than 72 hours remaining in their isolation period. The MDHHS will provide additional payment to hospitals for qualifying inpatient stays between Jan. 1 and Sept. 30, 2021.
The additional funding was a result of the MHA’s 2020 year-end advocacy efforts that totaled $3.3 million in gross funding for hospitals through Public Act 231 of 2020. The MDHHS will pay hospitals for each qualifying day until the funds are spent and will notify hospitals if the allotted funds for the additional payment are spent prior to the expected eligibility end date. The MHA encourages hospitals to complete and submit the template through the MDHHS File Transfer portal per the department’s instructions to receive the enhanced payment. Although the application period has been open for several months, a significant portion of funding remains available. Members that need a copy of the template may contact Jason Jorkasky at the MHA.