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 April 12

MHA Covid-19 update

A somber milestone was reached April 17 when, according to Johns Hopkins University data, the global number of deaths caused by COVID-19 surpassed 3 million. 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.

MHA Board of Trustees Focuses on COVID-19 Data, Vaccines

The MHA Board of Trustees held a virtual meeting April 14, where much of the agenda focused on COVID-19 as the spring surge continues to challenge Michigan communities and health system resources (see related article). Board members heard presentations on hospitalization and other surge-related COVID-19 data, which may be starting to show signs of improvement as growth rates and emergency department visit rates begin to slow and plateau. Despite these encouraging signs, healthcare providers must continue to urge their communities to stay vigilant in preventive actions.

Board members also discussed vaccine-related issues, including the Johnson & Johnson pause and how it may impact conversations around equity, hesitancy, safety/effectiveness and more. They also discussed efforts health systems can pursue to encourage as many employees as possible to be voluntarily vaccinated. For more information on the board meeting, contact Amy Barkholz at the MHA.

Board members also met April 12 via Zoom with U.S. Sen. Gary Peters (D-West Bloomfield), who expressed interest in the experience of hospitals and health systems during the current surge of infection. Members shared the damage the pandemic has done to staffing capacity by causing exhaustion and early retirements; the need for post-COVID-19 care for brain health including seizures, anxiety and depression; and the younger average age of hospitalized patients. Peters announced his Committee on Homeland Security and Governmental Affairs is doing a complete after-action study of the COVID-19 pandemic to improve preparedness and communications for future long-term crises. For more information about federal advocacy and policy, members may contact Laura Appel at the MHA.

J&J Vaccine Paused While Investigation Continues on Six Blood Clot Events

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), out of an abundance of caution, issued a statement April 13 that providers should halt administration of Johnson & Johnson (J&J) COVID-19 vaccines while they investigate six instances of blood clots in previously vaccinated individuals. More than 6.8 million J&J vaccines have been administered to date nationally, meaning these instances are extremely rare. All those affected were women between the ages of 18 and 48, and their symptoms developed six to 13 days after vaccination.

The CDC Advisory Committee on Immunization Practices (ACIP) met April 14 to discuss and review these incidents and, after several hours of debate, concluded that it would take additional time to review the cases and make a final recommendation for continued use of the vaccine. A decision is expected by the end of April.

Because the ACIP is an advisory committee, it is permissible, but highly unlikely, that the CDC and FDA would advise providers to resume use of the vaccine without a new recommendation from the ACIP. In the meantime, providers should continue to only use Pfizer and Moderna vaccines, and store/label J&J vaccines as instructed by recent alerts from the Michigan Department of Health and Human Services (MDHHS). The department stated, in part, “Clinics that are scheduled to administer J and J vaccine should be rescheduled to use a different vaccine. If you have inventory of this vaccine, please separate in your storage unit, mark do not use and store appropriately until further notice.”

The MHA will keep members apprised of recommendations as they become available. Members with questions on vaccines may contact Ruthanne Sudderth at the MHA.

Pfizer Requests Emergency Use Authorization for Younger Children

Pfizer recently asked the FDA to grant expanded emergency use authorization (EUA) of its COVID-19 vaccine for use in adolescents between the ages of 12 and 15. The request is based on data from Pfizer’s late-stage trial of the vaccine in children in this age group with or without prior evidence of COVID-19 infection, which demonstrated 100% efficacy and robust antibody response after vaccination.

The participants tolerated the vaccine with the incidence of side effects similar to adults, and Pfizer continues to monitor these adolescents. The company is also confident the vaccine will deliver long-term protection for as long as two years after the completion of dosage, although currently available data supports at least six months of protection. Since the vaccine is currently allowed to be used for anyone ages 16 and older, young Michiganders are urged to get vaccinated with the Pfizer vaccine as quickly as possible to prevent further spread among this age group, as well as illness, hospitalization and death.

Given the speed at which the expanded EUA could take effect, making 12- to 15-year-olds eligible for vaccination, health systems are encouraged to educate their family practice/pediatric care settings on administration of the Pfizer vaccine. The MHA will work with the Michigan Association of Family Physicians and the Michigan Chapter of the American Association of Pediatrics to coordinate messaging and resources. Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

FDA Recommends Moving Away from Decontaminated N95 Respirators

The FDA recently issued guidance recommending that healthcare personnel and facilities transition away from crisis capacity conservation strategies for N95 respirators. Due to an increased supply of respirators approved by the National Institute for Occupational Safety and Health, the FDA believes there is a sufficient domestic supply to allow organizations to transition away from decontamination or bioburden reduction and reuse of respirators intended as single-use items. The guidance does not specify a “days on hand” calculation for when the recommendations should be implemented; it simply references moving away from the crisis capacity strategy.

To date, the Michigan Occupational Safety and Health Administration (MIOSHA) has not issued guidance or statements on how it will interpret this FDA letter in Michigan. The MHA will continue to advocate with state leaders for organizational flexibility in determining their supply needs and crisis capacity strategies.

Organizations that have concerns about their supply of personal protective equipment (PPE) should contact the appropriate Regional Health Care Coalition. Members with questions or concerns on PPE may also contact Adam Carlson at the MHA.

MIOSHA Issues Permanent COVID-19 Workplace Rules

The MIOSHA released draft rules that would make permanent workplace regulations governing the use of PPE, physical distancing, contact tracing and other pandemic-related modifications. The MHA participated in a work group on the development of the permanent rules, but its suggestions to allow the rules to be flexible for updated CDC guidelines and to set an end date to the rules were not adopted in the draft rule set. The association followed up by submitting its recommendations to the MIOSHA in writing.

Emergency rules already in place on this topic were slated to expire April 14 and are expected to be extended to Oct. 14, 2021. The MHA hosted a webinar in December on that rule set for members, and the association will review the renewed emergency rules when they are available. The MHA will compile additional recommended changes to the permanent rule set prior to a public hearing being scheduled. Members with questions on the emergency or permanent MIOSHA rules may contact Adam Carlson 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).

CEO Report – Protecting the Financial Health of Hospitals

MHA Rounds Report - Brian Peters, MHA CEO

“Annual income twenty pounds, annual expenditure nineteen six, result happiness. Annual income twenty pounds, annual expenditure twenty pound ought and six, result misery.”Charles Dickens

MHA CEO Brian PetersThe past year has been extremely challenging for everyone across the globe. At the very top of that list: those who have lost loved ones to the pandemic, and those who have suffered from the often severe health consequences associated with COVID-19. At the same time, the financial blow to hotels, restaurants, bars, entertainment venues, and countless other businesses large and small has been well documented. And we all know about the mental health concerns brought about by income and job loss, the need for remote learning for students and the resulting lack of socialization, plus a host of other consequences that have accompanied this pandemic and negatively impacted people for many, many months now.

As a Michigander and a father, I care deeply about all of this. And as the CEO of the Michigan Health & Hospital Association, I have the great privilege of getting to do something about it every single day. After all, our very mission is to “advance the health of individuals and communities.” It is from this perspective that I can tell you how proud I am of our member hospitals and health systems throughout the state — and how concerned I am for the wellbeing of our caregivers and staff, and for the financial viability of the organizations themselves as the dark cloud of the pandemic continues to hover over all of us. Am I biased? Perhaps. But I truly believe that hospitals must be supported and protected at this time more than ever, for the betterment of our entire society.

Our members have now been serving on the front lines for over a year and have experienced significant physical and mental trauma. For those institutions that serve our local communities and employ our healthcare heroes, the last year has also been filled with financial uncertainty at best, and devastation at worst. Early in the pandemic, when elective procedures came to an abrupt halt, the double-edged sword of new, unbudgeted expenses related to ramping up to deal with COVID-19 combined with lost volume and revenue on an order of magnitude that we have never seen in modern times, pummeled our hospitals and health systems financially. For even our largest members, furloughs and layoffs became necessary.  And for our smaller, independent or rural hospitals, there were legitimate concerns about keeping the doors open in the face of severe cash flow disruptions.

Just one example of new costs: personal protective equipment (PPE) is a term Americans became all too familiar with last year. Our hospital supply chain leaders can verify that increasing the number of gloves, gowns, respirators, masks and face shields, both for immediate use and for the “new normal” stockpile requirements, is not only more expensive due to sheer quantity, but the prices have soared due to increased demand. To avoid dependence on the global supply chain, many organizations are now diversifying their network of suppliers and contracting with domestic companies. However, doing so comes at a cost, as domestic production is typically more expensive. This is just one of many factors that have driven hospital total expense per adjusted discharge higher by 19.6% over the past year, according to a recent analysis of national data from Kaufman Hall. Our own data and anecdotal evidence show that Michigan closely mirrors this trend.

Coupled with increased expenses is decreased revenue, as total patient volume has yet to recover to pre-pandemic levels. The same analysis from Kaufman Hall found that overall revenue (not including federal aid from the Provider Relief Fund) fell 4.6%, with emergency department visits decreasing 26.8%. As part of surge planning, hospitals have been forced to delay many nonemergency medical procedures.  Unfortunately, images of hospitals admitting COVID-19 patients and constructing temporary outdoor facilities also created a misplaced fear among a subset of the public that hospitals were no longer safe places of care. Much work, at both the state and federal level, has gone into correcting this misconception, but there remains a significant number of people who have legitimate healthcare needs who are still delaying care — to their own detriment. The resulting drop in patient volume and procedures has created a gap in hospital revenue that will take a long time to recover.

Lastly, the insurance coverage mix is also continuing to change for the patients utilizing our hospitals, specifically moving toward government programs or no coverage at all. According to the National Center for Coverage Innovation, Michigan had the sixth highest increase in newly uninsured adults, with 222,000 individuals becoming uninsured due to job losses, representing a 46% increase from 2018 levels. We’ve seen the growth borne out in the Healthy Michigan Plan (HMP), our state’s Medicaid expansion program, which has seen enrollment increase from a pre-pandemic level of approximately 650,000 beneficiaries to nearly 900,000 today. While continued coverage for all Michiganders is a top MHA priority, and we are incredibly thankful for the existence of the HMP, this transition from employer-sponsored health plans to government healthcare programs means more patient care is being reimbursed at a lower rate in contrast to the full cost of care.

To directly address all these challenges, the MHA has advocated strenuously for financial relief at the state and federal levels, and our members have been incredibly grateful for it. Federal funds such as the CARES Act helped to alleviate the immediate crisis, while providing a measure of financial stability to all hospitals (and serving as a real lifesaver for some). We have successfully delivered accelerated payments, targeted loans and grants, and more. One item of important relief that was implemented at the beginning of the pandemic was a moratorium on Medicare sequestration, the scheduled 2% cut to all Medicare payments that would have been a significant financial hit to hospitals and health systems at the worst possible time. Recently, legislation that delays these cuts through the end of the year passed the Senate with a bipartisan vote (thank you to our U.S. Sens. Debbie Stabenow and Gary Peters, for their support) and is expected to pass the House of Representatives once Congress returns from Easter recess. All of this is helpful — but none of this is a long-term solution to guarantee the financial viability of hospitals. Our members (even pre-pandemic) are doing their part to be innovative and increasingly focused on cost-effectiveness. But they need our continued support.

There is cause for optimism as we head down the road to recovery. Today, all adults 16 years and older are eligible to receive the COVID-19 vaccine in Michigan. Vaccine supply, which has increased dramatically in recent weeks, is expected to expand in the weeks ahead. In fact, we are very close to the day where the supply and demand curve flips and our efforts will need to focus on reaching vaccine-hesitant populations. The reasons to receive the safe and effective vaccines are many, as most importantly they prevent hospitalization and death and protect loved ones and those around you from contracting the disease. There is no better evidence than recent data the MHA released that shows hospitalizations are increasing the slowest among the age cohorts that have a higher percentage of vaccination.

Collectively, achieving our state’s goal of vaccinating 70% of the population allows our financial recovery to truly begin. To return to some sense of normal, everyone must do their part to mitigate the chance of future outbreaks. That tool is in our toolbox and it starts by scheduling a vaccine appointment. From there, restrictions and protocols placed on in-person office work, education instruction, and entertainment and leisure activities can be lifted. But we cannot trick ourselves into thinking that we can do all these things without reaching our vaccine goals first.

As Michigan hospitals deal with a legitimate third surge of COVID-19 patients, it takes everyone to do their part to put our state and communities on a path to recovery. By doing the right things, practicing preventive measures such as wearing a mask, social distancing, washing your hands and receiving a vaccine, we can protect both our physical health and the financial health of our hospitals that operate 24/7/365 to provide care when we need it. After all, the same hospitals that are needed to fight COVID-19 today are the hospitals that will be needed to treat auto accident victims, cancer patients and countless other loved ones in the future. They deserve our full support.

As always, I welcome your thoughts.