Tag: Sudderth

Combating the Novel Coronavirus (COVID-19): Week of Oct. 25

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Covid-19 update

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.

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 Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Oct. 18

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Covid-19 update

MHA Covid-19 updateThe 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.

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 Oct. 11

Member News, Issues in Healthcare, Top Issues - Healthcare
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 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.

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 Oct. 4

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Monday Report logo

MHA Monday Report logoThe 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.

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 Sept. 20

Member News, Issues in Healthcare, Top Issues - Healthcare
MHA Covid-19 update

MHA COVID-19 UpdateThe number of confirmed COVID-19 cases in Michigan since the beginning of the pandemic surpassed 1 million Sept. 20 and has continued to rise, hitting 1,008,069 by Sept. 24. Hospitalizations due to confirmed COVID-19 cases in the state have increased from 1,356 adults and 17 children Sept. 17 to 1,467 adults and 27 children Sept. 24. The percentage of Michiganders ages 16 and above who have received at least one dose of a COVID-19 vaccine has risen slowly in recent weeks to 67.4% as of Sept. 24.

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.

Weekly Allocation Model Set for Monoclonal Antibody Therapy

According to an alert shared Sept. 21 by the Michigan Department of Health and Human Services (MDHHS), the U.S. Department of Health and Human Services (HHS) has announced it will transition to a weekly allocation strategy for the distribution of monoclonal antibody therapy. The direct ordering feature through AmerisourceBergen has been suspended and will no longer accept orders. Sites that are actively administering monoclonal antibody therapy and need resupply must complete the updated mAb Allocation Request Form in its entirety. The form should be obtained from the MDHHS and submitted to the same address by noon ET each Wednesday to be considered to receive a supply. Submitting sites will be informed of approved product type and quantities upon review.

All sites requesting supply will be required to comply with the following data collection tools. Accurate utilization and inventory data will not only inform the MDHHS allocations and decision making, it will also impact allocations being made at the federal level.

The alert also contained information on redistribution of excess supplies of either of the approved monoclonal antibody therapy products, as well as the following topics.

  • Importance of Racial Equity and Monoclonal Antibody Therapy.
  • Emergency Use Authorization for Bamlanivimab + Etesevimab Expanded to Include Post-Exposure Prophylaxis.
  • Guidelines on Subcutaneous Administration of REGEN-COV Monoclonal Antibody Therapy.
  • Public Readiness and Emergency Preparedness Act Declaration: 9th Amendment.
  • U.S. Food and Drug Administration (FDA) Authorizes Shelf-Life Extension for Bamlanivimab.

MHA members may contact Ruthanne Sudderth at the MHA for more information.

Federal Agencies Grant Full Approval for Booster Shots for Older and At-risk Americans

The FDA and the Centers for Disease Control and Prevention (CDC) completed the approval processes for providing Pfizer COVID-19 booster shots Sept. 24, authorizing them for people aged 65 and older, long-term care facility residents, people aged 18-64 years old with underlying medical conditions that raise their chances of severe COVID-19, and people at risk because of on-the-job exposure, including healthcare workers.

The FDA earlier officially accepted the recommendations of its independent review panel, which voted to approve the extra shot of Pfizer. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted Sept. 23 to recommend the Pfizer booster, but voted against allowing the booster for those at risk because of on-the-job exposure, which differed from the FDA’s decision Wednesday to allow the booster for people with high-risk jobs. However, the CDC Director made the rare decision to contradict the ACIP’s recommendation and endorsed the use of Pfizer COVID-19 booster shots for workers at high risk of severe COVID-19, while formally accepting the remaining recommendations of ACIP for people 65 and older, nursing-home residents and people between 18 and 64 with underlying health conditions.

The CDC stated that providers may administer the booster dose of Pfizer to previous recipients of the Pfizer two-dose series who qualify (by age or health/risk status). The booster dose shouldn’t be administered until at least six months have passed since the recipient completed the two-dose primary series. Healthcare workers do qualify based on their regular exposure to the virus. There is no specific definition of healthcare worker in the authorization. Healthcare organizations and facilities have discretion to determine who in their settings should be able to receive the booster.

At this time, no other brand of vaccine is approved for an additional dose, though that is likely to change in the months ahead as more data becomes available.

The MDHHS has advised that health systems/hospitals should work to provide the booster to their own employees and to their patients to whatever degree is possible. Members should watch for MI Health Alert Network communications in the coming days for more information about the rollout of these Pfizer doses. Members can also regularly check the CDC’s Pfizer website for updated clinical information about the booster and the administration of these doses.

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).

Combating the Novel Coronavirus (COVID-19): Week of Sept. 13

Issues in Healthcare, Top Issues - Healthcare, Member News
MHA Covid-19 update

MHA COVID-19 UpdateCOVID-19 cases and related hospitalizations have continued to climb in Michigan, with 1,356 adults and 17 children hospitalized Sept. 17 with confirmed cases. The total number of confirmed cases in the state since the pandemic began is nearing 1 million, reaching 988,725 cases that had caused 20,665 deaths as of Sept. 17. Meanwhile, by Sept. 16, just 66.7% of Michigan residents ages 16 and over had received at least one dose of a vaccine to combat the illness.

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.

Hospitals May Verify Employee Vaccination Status Through MCIR

The MHA has been working with the Michigan Department of Health & Human Services (MDHHS) Division of Immunizations on changes that will allow hospitals to use the Michigan Care Improvement Registry (MCIR) to verify the COVID-19 vaccination status of employees to comply with state and federal data reporting rules. Hospitals may now use MCIR for this purpose; however, they must submit an additional form. The original MCIR provider agreement was meant for the establishment of a MCIR site for provider/patient relationships and does not cover providers as employers.

Hospitals and health systems that would like to use their existing MCIR site to do employee status checks need to complete the new MCIR Agreement “Provider as Employer” Addendum and send it to the Division of Immunizations Lansing Office as instructed on the Addendum. Before accessing MCIR to verify employee vaccination status, the employer must obtain written employee consent and retain it indefinitely to make available to the MDHHS upon request.

Organizations may also consider setting up a new MCIR site to effectively separate patient vaccination status checks from those for employees. To do so, they will need to complete a new MCIR Provider Agreement to establish the site and obtain a MCIR ID, and then complete the Addendum.

Additional functions for the MCIR system are being explored, and hospitals and health systems will receive additional information when they are in production. Members with questions may contact Ruthanne Sudderth at the MHA.

No Expansion of Expiration Date for Johnson & Johnson Vaccine

The Centers for Disease Control and Prevention has confirmed that expiration dates of the Johnson & Johnson COVID-19 vaccine have not been given an additional extension. Many unused doses will expire soon, and providers are urged to check their inventory to ensure no expired doses are administered. Expiration dates can be found by scanning the QR code located on the outer carton, checking the Janssen Expiration Lookup website or calling (800) 565-4008. Providers should use this vaccine only until the expiration date and then follow requirements for disposal and report wastage into MCIR.

Questions regarding vaccines may 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).