Tag: FDA

MHA CEO Report — Impact of Drug Shortages on Hospitals

MHA Rounds
MHA Rounds Report - Brian Peters, MHA CEO

“In the midst of every crisis, lies great opportunity.” — Albert Einstein

MHA Rounds Report - Brian Peters, MHA CEOThe shortage of key cancer treatment drugs carboplatin and cisplatin made national headlines in recent weeks, as hospitals implemented multiple strategies to maintain care for their patients when supply of these two drugs was remarkably low to nonexistent. While this shortage deservedly caught the attention of the nation, hospitals must navigate dozens to hundreds of drug shortages every day. This shortage is a worst-case example of how inefficiencies in the pharmaceutical supply chain can have devasting impacts on patient care.

Unfortunately, hospitals far too often must manage short supply of drugs, seek alternative sources for drugs, adjust treatment regimens and collaborate with other health systems to maximize supply. Hospitals throughout the state used all these tactics to respond to the recent crisis.

I’m proud the MHA was able to quickly raise the flag on this issue to our lawmakers as soon as we became aware of it. U.S. Senator Gary Peters (D-Bloomfield Twp.) chairs the Senate Committee on Homeland Security & Governmental Affairs and has prioritized drug shortages as a national security concern. His report from March 2023 shares a wealth of information on the subject, including all the problems associated with drug shortages and recommended solutions. His committee has been a key partner in providing accurate information about the shortage to Michigan hospitals.

In addition, U.S. Representatives Debbie Dingell (D-Ann Arbor) and Tim Walberg (R-Tipton) led Michigan’s US House delegation in sending a bipartisan letter May 24 to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to take immediate action to mitigate the effects of the nationwide shortage. I’m happy to share every member of our House delegation signed on to the letter, showing the health of our hospitals, patients and communities is truly a bipartisan issue.

Our work will continue on this issue far after the supply of these two drugs stabilizes, as the MHA supports several strategies that will address drug shortages. The first is relaxing prior authorization requirements from health insurers for alternative therapies during a shortage so they can be used widely. Federally, we believe establishing an early warning system will help avoid or minimize drug shortages so both manufacturers and providers have more time to respond to an upcoming shortage. Healthcare providers also welcome improved communication from the FDA and drug manufacturers, as there is often little to no transparency on the cause of a drug shortage. Lastly, changing the economic model to encourage drug manufacturers to stay in, re-enter or initially enter the market would be beneficial to all stakeholders. Many shortages occur with generic drugs due to a limited number of drug manufacturers.

In addition to the public policy arena, it is noteworthy that hospitals across the country – including several of our MHA members – helped to launch Civica, an entity that is helping to increase the production and availability of key generic drugs.  While not directly applicable to the current cancer drug shortage at this time, this effort is an example of the field looking to the future and doing all we can to ensure appropriate healthcare access to patients.

Finally, I’d like to lift up the MHA’s response to this crisis as a great example of the value of an association. Since we represent all acute care community hospitals in Michigan, we’re able to speak with a unified voice. The MHA has the relationships and institutional knowledge to quickly convene ad hoc groups in times of crisis to gather knowledge on the subject and what needs to be done, and then can execute and utilize our long-standing partnerships with lawmakers, both at the state and federal levels, to generate necessary awareness and action. By looking at national headlines, Michigan has been a leader in the shortage of carboplatin and cisplatin. That’s a testament to the health of our association and the culture we have helped to establish, whereby safety and quality engender collaboration and not competition within our hospital and health system membership.

As always, I welcome your thoughts.

MHA Continues Work Towards Chemotherapy Drug Shortage

Member News

The MHA has been in frequent contact with members of the Michigan Congressional delegation since the association was made aware of shortages of the chemotherapy drugs carboplatin and cisplatin. Representatives Debbie Dingell (D-Ann Arbor) and Tim Walberg (R-Tipton) led the Michigan delegation in sending a bipartisan letter May 24 to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to urge the FDA to take immediate action to mitigate the effects of the nationwide shortage of chemotherapy medications. Every member of the Michigan delegation signed on to the letter.

U.S. Senators Gary Peters (D-Bloomfield Twp.) and Debbie Stabenow (D-Lansing), along with U.S. Representative Elissa Slotkin (D-Lansing), wrote a separate letter to Dr. Califf asking that the FDA do everything in its power to mitigate the dire shortage of cancer drugs that has reached crisis levels in recent months.

The office of Sen. Peters also provided the following information to the MHA during the week of May 22 regarding the shortages.

  • The shortages for each drug are caused by the manufacturer Accord deciding to place production on hold, pending further assessments. Four other manufacturers of the drugs have not been able to fill the supply gap left by Accord.
  • The FDA has continued to work with Accord on prioritization of their assessments for product release and cisplatin and carboplatin are prioritized for release. Cisplatin is now being released following the assessment and supplies are making their way to hospitals and cancer centers. Meanwhile, carboplatin is planned to be released soon.
  • The FDA is also working with the other four manufacturers to increase supply and are offering expedited review of anything needed to increase supply, such as additional manufacturing lines, facilities and suppliers.
  • The FDA is requesting the manufacturers provide data to extend expiration dating for lots on the market that remain in distribution but are nearing expiration. Once received, the FDA will post the drug, old lot number and new lot number on the Extended Use database on the Drug Shortage website.
  • In addition, the FDA is exploring temporary importation to meet patient needs during the shortage. During temporary import, the FDA evaluates the overseas product attributes, as well as the manufacturing facilities, to ensure no risks exist for US patients.

Updates for both cisplatin and carboplatin are being provided by the FDA on the drug’s FDA Drug Shortage webpages.

Members with questions may contact Renee Smiddy with the MHA.

Patient Treatment Impacted by Shortage of Cancer Drugs

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Manufacturing delays at several pharmaceutical companies are causing nationwide shortages of two critical chemotherapy medications – forcing Michigan hospitals and health systems to find alternative treatments for patients, some of which may be less effective. The two drugs are cisplatin and carboplatin and are used to treat several types of cancer, including bladder, lung, ovarian and testicular cancers. The shortage of these chemotherapy drugs is widespread across the country, impacting hospitals throughout all regions of Michigan.

Both drugs are provided by healthcare providers as injections to oncology patients. The shortage of cisplatin was originally reported to the U.S. Food & Drug Administration (FDA) Feb. 10, 2023, while carboplatin was reported April 28, 2023. Both shortage durations are expected to last at least into June 2023.

To reduce the impact of shortages on patients, hospitals are trying many different solutions, including managing existing supply, seeking alternative sources for drugs in short supply, adjusting chemotherapy regimens for impacted patients and working with healthcare systems, as well as state and federal officials, to mitigate these challenges.

“The priority of hospitals is delivering the right care to every patient, every time,” said MHA CEO Brian Peters. “Drug shortages severely hamper a hospital’s ability to provide patients with the best treatment, while forcing hospitals to implement strategies that may increase the cost of care and sometimes do not offer the same effectiveness in treatment.”

This current shortage follows a national trend of drug shortages impacting healthcare providers for years. A survey of medical oncologists published in the New England Journal of Medicine found 83% were unable to prescribe their preferred chemotherapy agent due to shortages.

The MHA supports the following strategies that will address the issue:

  • Relaxing prior authorization requirements from health insurers for alternative therapies so they can be widely used, as appropriate.
  • Establishing an early warning system to help avoid or minimize drug shortages.
  • Removing regulatory obstacles faced by manufacturers and the FDA as a way of averting or mitigating drug shortages and allowing drug imports.
  • Improving communication with healthcare providers, including extent and timeliness of information. There often is no transparency on the cause of a drug shortage and many shortages occur with generic drugs.
  • Exploring incentives to encourage drug manufacturers to stay in, re-enter or initially enter the market.

Patients concerned about the impact of this drug shortage should contact their healthcare provider.

Healthcare Bills See Action as Session Resumes

Member News
capitol building

capitol buildingThe Michigan Legislature returned to session the week of April 10, taking up several bills the MHA is monitoring. In the House of Representatives, MHA-supported legislation to create a new tax credit for blood donations and to regulate the sale of kratom received hearings in their respective committees. In the Senate, a package of bills to license and regulate professional guardians was introduced and testimony was held on a bill to allow for pharmacists to order and administer certain vaccinations and diagnostic tests.

The House Committee on Tax Policy held a hearing on House Bill (HB) 4068 to create a new tax credit for blood donations in Michigan. Introduced by Rep. Rachel Hood (D-Grand Rapids), the bill would allow for a $25 state income tax credit for each blood donation during the tax year. The MHA is supportive of the bill, which is a unique way of encouraging good public health decisions in the state. A vote was not held at this hearing.

In the House Regulatory Reform Committee, an initial hearing was held on legislation to regulate the sale of kratom in Michigan. Kratom is a tropical tree native to Southeast Asia, with leaves that contain compounds which can have psychotropic effects similar to opioids and stimulants. HB 4061 would ban adulterated kratom products, require warning labels addressing the potential health impacts and require lab testing for kratom products to ensure consumers know what substances are present. HB 4061 is a reintroduction by Rep. Lori Stone (D-Warren) and was supported by the MHA’s Legislative Policy Panel last session. No vote on the bill was taken.

In the Senate’s Health Policy Committee, Sen. Sylvia Santana presented a new bill intended to increase access to vaccines and certain laboratory tests. Senate Bill (SB) 219 would allow pharmacists to order and administer vaccinations and certain diagnostic tests for their patients without physician supervision. Under the bill, the diagnostic tests pharmacists would be allowed to perform would be limited to those that are waived for home use by the Food and Drug Administration or approved for waiver under the Clinical Laboratory Improvement Amendments of 1988. The MHA has not yet taken a position on SB 219, which has also been introduced in the House as HB 4316 by Rep. Alabas Farhat (D-Dearborn). The MHA expects further testimony to be taken on the bill and no votes were held at this time.

In the Senate, a new package of six bills to amend regulations for professional guardians was introduced. SBs 253–258 include a wide range of proposals to increase the requirements for professional guardians, limit the number of cases a guardian can take and change the priority list for court-appointed guardians. The MHA has concerns with the legislation impacting a hospital’s ability to secure court appointed guardians in a timely manner to engage with healthcare and placement decisions. No hearing is scheduled on the bills at this time.

Members with questions about state legislative action can reach out to Adam Carlson for more information.

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

Issues in Healthcare, Member News
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

Member News
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

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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 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

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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 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 Aug. 23

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