Tag: MAB

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 May 3

Member News, Issues in Healthcare, Top Issues - Healthcare
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

Top Issues - Healthcare, Member News, Issues in Healthcare
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 April 19

Member News
MHA Covid-19 update

Michigan continues to make good progress vaccinating our adult eligible population as Michigan exceeded over six million COVID-19 vaccine doses administered April 16, displaying significant progress in Michigan’s effort to achieve the goal of vaccinating at least 70% of Michigan adults. 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.

MDHHS Issues Multiple Vaccine-Related Alerts

The Michigan Department of Health and Human Services (MDHHS) issued multiple vaccine-related provider communications in the past week.

  • Vaccine Administration Error Guidance: The MDHHS sent providers several resources and reminders about how to proceed when questions arise about restarting the vaccine process if the second dose timeframe is missed and more. In short, providers should not “start the vaccine process over” with an additional first dose if the second dose timeframe is missed. Please reference guidance from the Centers for Disease Control and Prevention (CDC) for instructions on this and other administration error issues.
  • Bamlanivimab FDA EUA Revoked: The U.S. Food and Drug Administration (FDA) revoked April 16 the emergency use authorization (EUA) for bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients who are at high risk of disease progression or hospitalization. MDHHS stated that REGEN-COV as well as bamlanivimab and etesevimab (administered together) continue to be available under EUA.

Sites that are administering monoclonal antibodies can order bamlanivimab and etesevimab, etesevimab to pair with the current supply of bamlanivimab that the site has available, or REGEN-COV from the authorized distributer using the direct ordering process. The MDHHS continues to encourage all providers to consider offering antibody treatments to prevent severe COVID/COVID hospitalizations and is working on additional offerings to assist providers in this effort.

Additional Vaccine Updates

  • State leadership reported to the MHA a slight improvement in Michigan’s vaccination speed, but a desire to continue to lessen vaccine supply on hand to ensure resources from federal partners remain in place. As of April 23:
    • 2.7 million Michiganders, or 33% of the eligible population, have received complete schedules of COVID-19 vaccines either through two doses of an mRNA vaccine or one Johnson & Johnson dose.
    • 6.3 million doses have been administered in total.
    • 3.8 million people have initiated vaccination, or 47% of the eligible population.
    • 65% of people 65 and older are now fully vaccinated.
  • Hospitals and health systems are encouraged to consider working with local employers, local industries such as hospitality businesses, or local colleges/universities to offer specific clinics to employees or students of those organizations. Because some employers’ work or shift hours can be irregular, partnering with them to offer clinics at times when their employees are available could improve access for those individuals. The MHA will continue to pursue conversations with the trade groups representing such stakeholders to identify any opportunities for statewide or regional coordination.

There is also still a need for increased vaccine access for homebound individuals. As a reminder for any clinic offering, many local transit authorities around the state have offered free rides to vaccine clinics for individuals in need of transportation. If you’d like to arrange transportation to your clinics, please contact your local transit authority.

  • The state announced it is seeking vendors to execute mobile vaccinations. Awards will be based on the ability to provide services to one or more of the six site types and multiple awards may be issued. Contractors will also be responsible for rapid response to provide vaccinations (and potentially testing) at locations and community locations when COVID-19 outbreaks occur. Members that may be interested in this contract should review the full announcement for other details about expectations, and be aware that bids are due Wednesday, May 12 by 3 p.m. RFP No. 210000001690 is posted on the SIGMA Vendor Self-Service at Michigan.gov/SIGMAVSS.
    • On a related note, the state shared some entities in Michigan are using their Meals on Wheels operations via their Area Agency on Aging to deliver vaccinations out in the community and/or to homebound individuals. Members are encouraged to consider these partners if they haven’t already and have capacity to do so.
  • Pfizer continues to work on smaller quantity packages of their vaccine, to allow smaller provider settings to use their product without risk of waste or storage issues. Those smaller quantities are not yet available; we will keep members apprised of any updates.

Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

Care and Recovery Centers Remain Available for Patients

Hospitals are reminded that the MDHHS has established Care and Recovery Centers (CRC) to care for confirmed COVID-19 positive patients discharging from a hospital requiring isolation until Transmission-Based Precautions are discontinued. Currently, the MDHHS has 14 designated nursing facilities with approximately 300 beds across the state serving as CRCs. Within each CRC exists a designated unit to properly isolate and care for confirmed COVID-19 positive individuals. Hospitals are encouraged to coordinate with CRCs as part of their discharge planning process of confirmed COVID-19 positive hospital patients. Patients admitted directly from the hospital do not need to meet MDHHS Nursing Facility Level of Care. Members with questions may contact Kelsey Ostergren.

mAb Webinar Recap and Recording

The MHA and MDHHS this morning hosted a webinar for health system and hospital leaders to learn more about the overall benefits of, and operational considerations for, increasing the administration of monoclonal antibody therapies for eligible COVID-19 patients.

The webinar highlighted what resources, time, space and support is needed to administer mAb treatment and what the state has in place to assist. Earlier this week, the MDHHS issued an alert on the Michigan Health Alert Network to hospitals and health systems that included the following resources. The MDHHS has set a goal of at least 50% of people who are eligible to receive mAb therapy receive the treatment within 10 days of symptom onset.

  • A memo from MDHHS Chief Medical Executive Joneigh Khaldun, MD, encouraging hospitals and health systems to increase use of mAb treatment to prevent hospitalizations/death from COVID-19;
  • A summary of current recommendations;
  • FAQs for clinicians;
  • A summary of current evidence;
  • And considerations for hospitals.

A recording of the webinar can be found online. Members with questions may contact Laura Appel.

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).