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

MHA Covid-19 update

Michigan’s COVID-19 case numbers and hospitalizations have increased since early July with the onset of omicron variant BA.5. Here are the latest key statistics:

  • 875 hospitalizations with confirmed or suspected COVID-19, a 20% increase since July 1.
  • 23 pediatric hospitalizations with confirmed or suspected COVID-19.
  • 67.6% of all residents have at least one dose of vaccine.
  • 29.2% of kids aged 5-11 have now initiated vaccination.
  • Roughly 2% of kids aged 6 months-5 years have initiated vaccination since approval was granted in mid-June.

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.

Governor Signs COVID-19 Liability Legislation

Gov. Gretchen Whitmer recently signed several COVID-19 liability-related bills:

  • House Bill 5244 (Public Act 138 of 2022) amends Public Act 238 of 2020, which prohibits an employer from taking certain actions against an employee who does not report to work under circumstances related to COVID-19, to specify that the Act would not apply to a claim or cause of action that accrued after July 1, 2022. In addition, the bill will repeal PA 238 of 2020 effective July 1, 2023. HB 5244 was sponsored by Rep. Andrew Fink (R-Hillsdale).
  • House Bill 6128 (Public Act 140 of 2022) amends Section 85 of the Michigan Occupational Safety and Health Act to specify that certain conditions establishing immunity for employers whose employees were exposed to COVID-19 would not apply to an exposure that occurred after July 1, 2022. In addition, the bill would repeal Section 85 and Section 85a, which defines COVID-19 under the Act, effective July 1, 2023. HB 6128 was sponsored by Rep. Yousef Rabhi (D-Ann Arbor).
  • House Bill 6215 (Public Act 139 of 2022) amends the COVID-19 Response and Reopening Liability Assurance Act to specify that the Act, which provides immunity to a person that acts in compliance with certain federal, state and local orders related to COVID-19, would not apply to a claim or cause of action that accrued after July 1, 2022. In addition, the bill would repeal the Act effective July 1, 2023. House Bill 6215 was sponsored by Rep. Graham Filler (R-DeWitt).

Novavax Vaccine Gets FDA Authorization

The Food and Drug Administration (FDA) granted emergency use authorization to Novavax’s COVID-19 vaccine July 13. The vaccine is a two-dose series administered three weeks apart and uses a different, older vaccine technology than is used in the messenger RNA vaccines and Johnson & Johnson shot.

Novavax’s vaccine is authorized for people ages 18 and older as a primary series. It may be appealing to those adults who were hesitant to receive another brand of vaccine due to the components or development process.

In a trial of more than 26,000 adults, two doses of the Novavax COVID-19 vaccine were more than 90 percent effective at preventing symptomatic disease. For adults 65 and older, effectiveness was more than 78 percent. There were no serious side effects or safety concerns.

The Centers for Disease Control and Prevention (CDC) will next decide whether it will endorse the vaccine. The CDC Advisory Committee on Immunization Practices will meet July 19, though an agenda is not yet available.

The Biden administration recently announced that it had purchased 3.2 million doses of the Novavax vaccine. If the vaccine is recommended by the CDC, it will be made available at no cost to states, jurisdictions, federal pharmacy partners and federally qualified health centers. The MHA will keep members apprised of vaccine availability and ordering processes at the appropriate time. Members with 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).

Bills on ED Violence, COVID-19 Medication, Auto No-fault Discussed in State Legislature

Michelle Pena, chief nursing officer for Mercy Health Saint Mary’s, testifies on HBs 5084 and 5682.

The Michigan Legislature returned to Lansing the week of Jan. 24 to address several bills relevant to Michigan hospitals. In the House Government Operations Committee, testimony was taken on a pair of bills to expand penalties for assaulting emergency department employees. The House Health Policy Committee held a hearing on legislation to allow physicians to prescribe certain off-label medications to patients terminally ill with COVID-19, and a bill to make changes to Michigan’s auto no-fault insurance law was introduced in the House.

The MHA provided written testimony in support of House Bills (HBs) 5084 and 5682, which would expand the penalties for assaulting emergency department employees. In addition, Michelle Pena, chief nursing officer for Mercy Health Saint Mary’s in Grand Rapids, testified before the committee Jan. 26 in support of the bills. The legislation would bring Michigan in line with 32 other states where it is a felony to assault healthcare workers or emergency medical personnel. HBs 5084 and 5682 were introduced by Rep. Ben Frederick (R-Owosso) and Mike Mueller (R-Linden), respectively, and would provide further protection within hospital emergency departments. The MHA offered the committee potential amendments to expand the legislation to protect healthcare workers in all care settings and will continue to monitor the legislation.

The House Health Policy Committee took testimony on HB 5637, which would allow physicians to prescribe certain off-label medications to patients terminally ill with COVID-19. The bill amends the “Right to Try Act,” which is intended to give patients access to medications that are still in trial with the Food and Drug Administration for their condition or have already been approved to treat another diagnosis. As currently written, HB 5367 would allow off-label medications to treat COVID-19 to be prescribed only by the treating physician, and the bill would not require healthcare facilities to offer new medications or services that they do not already provide. The MHA has not taken a position on HB 5637.

Rep. Phil Green (R-Millington) introduced HB 5698 in the House Jan. 26 to modify the Michigan auto no-fault insurance law. Since the July 1 implementation of new reimbursement tiers, hospitals have faced significant issues in provider reimbursement, in addition to patients being transferred to hospitals after losing access to post-acute care. The bill seeks to clarify payments between auto insurers and providers and establish additional provisions to reimburse long-term care treatments. The legislation was referred to the House Insurance Committee. The MHA supports the bill as part of broader legal and regulatory efforts to clarify the existing law and will keep members apprised of its progress.

For more information on state legislation related to healthcare, contact Adam Carlson at the MHA.

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 Sept. 20

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 Aug. 23

MHA Covid-19 update

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 Issues Full Approval of Pfizer COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) Aug. 23 issued full approval of the Pfizer COVID-19 vaccine for individuals 16 and older, making it the first shot to move past the emergency use authorization phase. In doing so, the FDA reviewed hundreds of thousands of pages of safety and efficacy data, reaffirming the mRNA vaccine to be highly safe and effective. The MHA issued a media statement about the approval shortly after the announcement. For children ages 12 to 15, the shot remains under emergency use authorization. Emergency authorization of this and other vaccines for anyone younger than 12 remains outstanding and could come by the end of 2021.

The required vaccine fact sheets for providers’ use have been updated and are posted to the state’s Pfizer-focused webpage.

The lack of FDA approval has been a primary talking point for individuals delaying getting their COVID-19 vaccines. The MHA is communicating with media outlets and on its social media channels about the approval and where individuals can get vaccinated, especially as children head back to school. As of Aug. 23, the rate for children ages 12 to 15 who are fully vaccinated was 30%, and the rate for children ages 16 to 19 was 39.2%.

First doses of the vaccine continue to be administered at a slow but steady pace, with Michigan having administered nearly 154,000 first doses from Aug. 1-26. Providers – especially those who see younger patients – are urged to do direct patient outreach to increase vaccination rates and ensure those who are immunocompromised get a third dose if they received an mRNA vaccine. The MHA is developing provider outreach tools for practice settings to assist with these efforts.

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

Bridge Magazine Hosting Youth Mental Health Conversation Aug. 31

Bridge Magazine, which the MHA supports as an underwriter of its Health Watch series, is hosting a free, online, one-hour conversation on youth mental health in Michigan from noon to 1 p.m. Aug. 31. MHA members are invited to participate in the online event by registering online.

The dialogue will include a description of the state of youth mental health services in Michigan as well as potential solutions for improving the availability of mental healthcare for youth and their families. Improved access to high-quality behavioral health services for Michiganders remains a top priority of the MHA, as evidenced by its proposal for an additional $125 million in the state budget dedicated to this issue. The MHA Board of Trustees held a robust discussion on behavioral health at its recent meeting, and more details on how the association will be dedicating resources to this issue are forthcoming.

Panelists for the event include Zakia Alavi, staff psychiatrist at LifeWays Community Mental Health in Jackson; Kevin Fischer, executive director of the National Alliance on Mental Illness, Michigan Chapter</a>; and Tim Michling, research associate – Health Affairs at the Citizens Research Council of Michigan. The hour-long discussion will be moderated by Bridge health reporter Robin Erb.

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).

MHA Statement on Full FDA Approval of Pfizer's COVID-19 Vaccine

MHA CEO Brian Peters

The following statement can be attributed to Brian Peters, CEO of the Michigan Health & Hospital Association. 

MHA CEO Brian PetersThe MHA and our member hospitals and health systems across Michigan are pleased that the FDA this morning issued full approval of the Pfizer COVID-19 vaccine. The agency reviewed hundreds of thousands of pages of safety and efficacy evidence and reaffirmed that this vaccine is extremely safe and effective at preventing COVID-19 – especially hospitalization and death. This particular vaccine is currently available for anyone aged 12 and older. Currently, a large majority of the people in Michigan hospitals with COVID are NOT fully vaccinated. We urge everyone eligible to get their vaccines – which are free and readily available through pharmacies, health departments, local clinics, health systems and more – as quickly as possible. The delta variant is quickly spreading in Michigan; we now have more than 1,000 of our neighbors and friends in hospital beds fighting this virus. Please support our healthcare workers, protect yourself and your family and stop this virus by getting your vaccine immediately and putting a mask on in public when appropriate. The evidence proves that these two simple steps work. We can beat this together.

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 Aug. 24

MHA Covid-19 update

MHA COVID-19 UpdateThe MHA continues to keep members apprised of developments affecting Michigan hospitals during the pandemic through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Interim Final Rule Ties COVID-19 Reporting to Medicare Conditions of Participation

The Centers for Medicare & Medicaid Services (CMS) Aug. 24 issued an interim final rule that, among other provisions, makes collecting COVID-19 data and reporting it daily to the Department of Health and Human Services (HHS) a condition of participation (CoP) for hospitals that participate in Medicare. The MHA is disappointed in this rule that seeks to obtain data by penalizing hospitals as they continue to fight against a global pandemic.

The rule takes effect upon publication in the Federal Register, after which comments will be accepted for 60 days. The date the rule will be published is currently unknown.
The rule requires hospitals to daily report data including, but not limited to, number of confirmed or suspected COVID-19-positive patients, intensive care unit beds occupied and availability of supplies and equipment. By making this data reporting a CoP, the potential penalty for a hospital’s noncompliance could be termination from the Medicare program unless appropriate corrective action is taken.

While the MHA works to diminish the negative effects of this rule, hospitals are urged to report data through the HHS TeleTracking portal on a daily basis to avoid potential violation of the rule when it is published. Members needing assistance in meeting the reporting requirements should contact Jim Lee at the MHA.

Raising Awareness of Importance of Flu Vaccinations During Pandemic

The MHA is teaming up with Gov. Gretchen Whitmer and other healthcare organizations to promote flu vaccination during the upcoming influenza season. The potential for a surge of COVID-19 and severe outbreaks of influenza circulating simultaneously could overwhelm the healthcare system. MHA CEO Brian Peters participated in a news conference Aug. 25 to stress the importance of improving flu vaccination rates in Michigan (see related article).

FDA Approval or Authorization Unnecessary for Laboratory Developed Tests

The HHS recently announced that the Food and Drug Administration (FDA) will not require developers to submit a premarket approval application, premarket notification or emergency use authorization (EAU) for laboratory developed tests (LDTs). Laboratories opting to use LDTs would not be eligible for Public Readiness and Emergency Preparedness Act coverage and would remain subject to CMS regulation under the Clinical Laboratory Improvement Amendments of 1988 and its implementing regulations, the HHS said. LDT developers may voluntarily apply for approval, clearance or an EUA, and the FDA will adjudicate those submissions.

LDTs are developed, validated and performed by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs. The American Hospital Association has urged the agency not to regulate LDTs as medical devices, which would reduce patient access to many critical tests and hinder technological and clinical innovation.

Sept. 9 Twitter Chat to Focus on Mental Health During the Pandemic

A recent Kaiser Family Foundation poll determined that 53% of adults in the U.S. are experiencing poor mental health due to worry and stress over COVID-19. To help educate and encourage conversation around mental health as it relates to COVID-19 and National Suicide Prevention Awareness Month, the MHA will host a Twitter chat from 1 to 2 p.m. Sept. 9. The chat will feature input from guest expert Brian Ahmedani, PhD, director, Center for Health Policy & Health Services Research at Henry Ford Health System (@bahmedani).

Those interested in participating may follow along through the MHA’s Twitter (@mihospitalassoc) or by searching the hashtag #MHAHealthChat over the course of the hour. Additional details will be emailed to MHA members prior to the event. Those with questions may contact Lucy Ciaramitaro 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 Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC). Members with MHA-specific questions should contact the following MHA staff members: