Beyfortus Supply Shortages & CDC Guidelines

Beyfortus (nirsevimab) is a long-acting monoclonal antibody for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants approved by the U.S. Food and Drug Administration in July 2023. The MHA has heard significant concerns from members about the cost of purchasing and administering Beyfortus for infants entering their first RSV season since the drug was approved and has been working diligently to alleviate barriers.

The MHA sent letters to Blue Cross Blue Shield of Michigan (BCBSM) and the Michigan Association of Health Plans (MAHP) Oct. 23 to encourage coverage of Beyfortus so cost is not a barrier to adequate protection for the most vulnerable infants. Additionally, the MHA has engaged in conversations with the Michigan Department of Health and Human Services and the Medicaid health plans to confirm Beyfortus is covered through the federally funded Vaccines for Children program. Updates on coverage will be shared as soon as they become available.

The Centers for Disease Control and Prevention (CDC) released a Health Alert Network (HAN) advisory Oct. 23 providing guidance for clinicians in administering Beyfortus given current supply shortages. This follows release of a statement from Sanofi, Beyfortus’ manufacturer, indicating demand for the product has been higher than anticipated and supply has not kept pace, despite an aggressive supply plan.

The CDC’s interim recommendations for prioritizing Beyfortus administration include prioritizing administration of 100mg nirsevimab doses for:

  • Infants younger than six months old.
  • American Indian and Alaska Native infants younger than eight months old.
  • Infants between six to eight months with underlying health conditions that put them at high risk of severe RSV disease.

In addition, children eight to 19 months old should not receive nirsevimab, if they are eligible for palivizumab (Synagis). Lastly, providers should not utilize two, 50mg nirsevimab doses in lieu of one, 100mg dose for infants greater than 11 pounds.

Members may refer to the CDC HAN advisory for the complete recommendation. Members experiencing challenges with billing or reimbursement for Beyfortus administration should contact Kelsey Ostergren at the MHA.

MHA CEO Report — Leading with Safety & Quality

“Do the right thing. It will gratify some people and astonish the rest.”  Mark Twain

Last month’s CEO Report focused on our grave concerns with legislative proposals to mandate nurse staffing ratios, and the negative impact they would have on patient access to care. And we spent the entire month of September laser-focused on telling our story to elected officials, the media, business and healthcare trade groups and many others who care about the Michigan healthcare ecosystem. This advocacy work will continue, without question.

But the hallmark of the MHA and our members is to not simply advocate against bad public policy, but rather, to voluntarily do the right thing when it comes to the best interests of the patients and communities we serve. And when it comes to the safety and quality of the care we provide in Michigan hospitals, we indeed have a very special story to tell.

This year marks the 20th anniversary of the inception of the MHA Keystone Center, which was originally created in 2003 as a first-of-its-kind collaboration among hospitals to identify and implement practices that improve healthcare safety and quality and reduce cost. Acting as our safety and quality organization today, the MHA Keystone Center voluntarily identifies safety and quality improvement opportunities and develops solutions among Michigan hospitals to improve experiences for both patients and healthcare workers alike. The extraordinary partnerships among MHA Keystone Center hospitals have saved many lives as well as healthcare dollars.

It needs to be stressed that there is no mandate requiring participation; all Michigan hospitals and thousands of their team members voluntarily participate in MHA programs to improve the safety and quality of healthcare because of their missions to care for the sick and vulnerable. Because of our long history of success, a growing number of hospitals in other states are now part of MHA-led safety and quality initiatives. In addition, the hospital-based collaborative efforts first pioneered by the MHA Keystone Center have now been replicated in 48 of the 50 U.S. states and various other countries.

These initiatives are driven by evidence-based best practices and strongly supported by data. One great example of how engaged hospitals have seen great improvements on safety and quality outcomes is through the MHA Keystone Center’s leadership of the Great Lakes Partners for Patients (GLPP) Hospital Improvement Innovation Network (HIIN). Michigan hospitals saved 3,350 lives and avoided 25,304 harm events within hospitalized patients over a three-and-a-half-year period from Sept. 2016 to March 2020.  In addition, our track record of outcome improvements includes the following:

  • Reduced the rate of CAUTI (catheter-associated urinary tract infection) events by 49% between 2012 – 2018.
  • Decreased CLABSI (central line associated blood stream infection) rates within ICUs by 35% between 2015 – 2018.
  • Reduced early elective deliveries by 68% between 2010 – 2018.
  • Reduced C. Diff rates by 15% from 2014 to 2017.
  • Reduced postoperative pulmonary embolisms and/or deep vein thrombosis by 22% from 2014 to 2016.
  • Reduced colorectal surgical site infections by 27% from 2014 to 2016.

This successful work led to the subsequent creation of the Superior Health Quality Alliance (Superior Health), which includes the MHA Keystone Center, along with our counterparts at the Illinois, Wisconsin and Minnesota hospital associations, and several other related organizations in the Midwest. Superior Health is funded by the federal government, which has clearly valued the ROI that is created by this work, both for Medicare and Medicaid patients for which they have a direct responsibility, as well as all patients.

On top of this work, the MHA Keystone Center has led hospitals on a high reliability journey for almost ten years now. Striving towards implementing and maintaining a high reliability culture means hospitals are focused on attaining zero preventable harm to patients, families and caregivers, making Michigan a safe place to receive care. Factors such as the pandemic, workforce shortages and increased rates of violence against healthcare workers all have emerged as challenges to this work. However, MHA Keystone Center member hospitals remain steadfast in their quest to reduce unintended harm in their facilities. One great example of how hospitals implement a high reliability culture is by stressing the importance of speaking up to prevent potential harm to patients or other staff members. Dozens of healthcare workers from hospitals throughout Michigan have been recognized by the MHA Keystone Center Speak-up! Award since it was launched in 2016.  It is heartening that hospitals across the state, both large and small, urban and rural, have embraced an organizational culture that promotes and even celebrates anyone within the organization who speaks up to prevent harm.

Our to-do list in this realm is long and is constantly evolving. Based on the current needs of our membership, we are now focusing on reducing health disparities as our state strives to achieve health equity; improving maternal health outcomes; establishing age-friendly health systems; implementing solutions to address the opioid epidemic; facilitating person- and family-centered care; improving workplace safety; and providing emotional well-being support to healthcare workers through a partnership with the Duke Center for Healthcare Safety and Quality that has so far assisted 5,000 healthcare workers from 144 organizations throughout Michigan.

We know each of these efforts impact the health and well-being of countless Michiganders today. Thankfully, we have diverse funding support for our work; in addition to the federal government’s role noted above, the MHA Keystone Center has been funded by the Michigan Health Endowment Fund, and from our own hospitals who pay an annual fee for the services provided by our MHA Keystone Center PSO, a federally-certified Patient Safety Organization which collects adverse event data. But special recognition needs to be given to Blue Cross Blue Shield of Michigan (BCBSM), and their CEO Dan Loepp. Their initial support was instrumental in getting the MHA Keystone Center off the ground all those years ago, and we are now operating under a third round of very significant financial support from BCBSM that has been critical to our success.

Finally, I would like to acknowledge the great leadership of Sam Watson, our senior vice president of field engagement, and Sarah Scranton, our vice president of safety & quality, as well as the entire MHA Keystone Center Board of Directors, and of course the incredibly talented and dedicated MHA Keystone Center staff. We are proud to work every day with so many hospital leaders and clinicians who are dedicated to doing the right thing for patients and healthcare workers. At the end of the day, this is mission-driven work that all Michiganders can be proud of.

As always, I welcome your thoughts.

MHA Keystone Center Hosts Safe Patient Handling Event April 13

Healthcare workers across the state gathered April 13 in Southeast Michigan to discuss best practices for patient handling to ensure the safety of both the patient and the caregiver.

The MHA Keystone Center partnered with EarlyMobility.com to bring live safe patient handling demonstrations and interactive mobility equipment activities to more than 60 occupational therapists, quality and risk managers, nurses, physical therapists and physicians. Participants discussed the importance of safe, early and continuous mobility and how properly utilizing mobility equipment ultimately is in the best interest of patients and caregivers. Presenters also highlighted the cost and time savings that come from prioritizing revised best practices for patient handling and mobility.

The event was made possible by Blue Cross Blue Shield of Michigan’s support of the MHA Keystone Center and its ongoing quality and safety initiatives. The MHA Keystone Center partnered with the following equipment vendors for the event’s live patient handling demonstrations: Arjo, Hovertech International, Inspire Outcomes LLC, Jamar Health Products, Inc. and Medcotech. The Michigan Occupational Safety and Health Administration also collaborated with members throughout the event.

Members with questions may contact the MHA Keystone Center.

MHA Keystone Center and MVC Release Statewide Childbirth Outcomes Report

The MHA Keystone Center and the Michigan Value Collaborative (MVC) developed and released a statewide report Feb. 2 on birth outcomes following recently released data from the Centers for Disease Control and Prevention (CDC) in an effort to support maternal health quality improvement initiatives. CDC data shows the maternal mortality rate in the United Sates was 23.8 per 100,000 live births in 2020 and four in five pregnancy-related deaths were preventable between 2017 and 2019.

The Michigan report details information on episode payments, mode of delivery, patient characteristics and rates of hemorrhage, hypertension and severe maternal morbidity for 90-day claims-based episodes of care for vaginal and cesarean delivery at MVC participating birthing hospitals from January 2019 to December 2021. It found 7.5% of patients had a diagnosis of hemorrhage, 4.2% had a diagnosis of hypertension and 1.8% had a diagnosis of severe maternal morbidity (SMM) during their index birth hospitalization. A notable finding was the difference in rates of these complications by race. Patients who were identified as Asian or Pacific Islander had higher rates of hemorrhage than other race categories, while patients who were identified as Black had higher rates of hypertension and SMM than the overall population.

Through support from Blue Cross Blue Shield of Michigan, this report helps to better understand disparities in care while guiding the MHA Keystone Center’s efforts to increase equitable care and decrease preventable several maternal morbidity and mortality.

Members with questions about the report may reach out to the MHA Keystone Center.

Registration Available for MHA Keystone Center Safe Patient Handling Conference

Registration is now open for the MHA Keystone Center Safe Patient Handling Conference. The all-day event will take place April 13 at the Ann Arbor Marriott Ypsilanti at Eagle Crest.

In partnership with the MHA Keystone Center, EarlyMobility.com and Blue Cross Blue Shield of Michigan, the free event will provide participants with a better understanding of how caregiver and patient safety are connected. Attendees will also learn how safe, early and continuous mobility can help achieve better patient outcomes in less time with fewer staff.

Participants will view live simulations demonstrating best practices for patient handling and discuss how to avoid care activities that cause caregiver injury and compromise quality of care.

Risk and safety officers, physicians, nurses, physical and occupational therapists and worker’s compensation staff are encouraged to register.

Nursing, physical therapy, risk management and quality credits have been secured for the event. Continuing education credits for occupational therapy are being pursued.

About the speakers:

Margaret Arnold

Margaret Arnold is one of the world’s foremost experts on early mobility and is CEO of EarlyMobility.com. Margaret has over 25 years of experience as a PT, specializing in back injury treatment and prevention, industrial rehabilitation, ergonomics and safe patient mobility. You can often catch Margaret both domestically and internationally speaking at conferences related to PT, early mobility and safe patient handling. She is the editorial advisor on early mobility for the International Journal of Safe Patient Handling and has a seat on the board of directors for the American Safe Patient Handling Association.  She has published extensively on both topics and is a pioneer in integrating early mobility programs with safe patient handling programs.

Janice Homola

​Janice Homola is President Emeritus of the Michigan Health Care Safety Association (MHCSA). As a certified safe patient handling associate (CSPHA), Janice specializes in safe patient movement and mobility by conducting gap analyses, collaborating to determine improvements, providing coaching and education and by improving organizations’ cultures of safety.

Janice was co-developer and presenter for five years for MIOSHA funded, statewide seminars, On the Backs of Healthcare Workers, to spotlight the depth and breadth of patient movement challenges and provide innovative solutions. She participated with MIOSHA in ergonomic standard development and provided safe patient movement education to MIOSHA’s Consultation Education and Training division.

Members with questions about the conference may contact the MHA Keystone Center.

EarlyMobility.com is an AOTA Approved Provider of professional development. This live event is an introductory level course. The assignment of AOTA CEUs does not imply endorsement of specific course content, products of clinical procedures by AOTA.

 

MHA CEO Report — Medical Liability and Denney Damages

“I have gained this by philosophy; I do without being ordered what some are constrained to do by their fear of the law.” ― Aristotle

In last month’s CEO Report, we focused on the new political environment in Lansing, with a host of first-time lawmakers taking office, Democrats assuming majority control of both chambers of the legislature and a host of new leaders in key roles. The playing field has changed in a palpable way.

As healthcare leaders, the list of emerging challenges may seem endless today, ranging from unprecedented labor shortages, inflation, cybersecurity and much more. But as the new legislative session ramps up, we also can’t turn a blind eye toward issues from years past which have the potential to rear their ugly head once again. Medical liability is at the top of that list and merits our close attention.

One of the MHA’s signature achievements over the past thirty years was the passage of sweeping medical liability reforms in the early 1990s. Our leadership and collaboration with our friends in organized medicine and other partners helped to directly address a situation that had become untenable for Michigan: runaway verdicts in medical liability cases were threatening the financial viability of hospital-based service lines (and even entire hospitals). Doctors, particularly those in high-risk specialties, were leaving the state in droves and our recruitment efforts faced an extraordinarily high hurdle.

Since the passage of our reforms, which brought reason and predictability to the system, medical liability has been relatively stable for nearly three decades, even as the caps on noneconomic damages continued to grow with inflation. And over the years, the MHA has been extremely vigilant, advocating to preserve these reforms both in the legislative arena and in the courts, where we have filed countless amicus curiae briefs on behalf of our members and the healthcare field. However, a recent decision by the Michigan Supreme Court is bringing these concerns back to the forefront of our minds.

The case of Estate of Langell v McLaren Port Huron, heard by the Michigan Supreme Court in 2022, ultimately affirmed a Court of Appeals decision that a plaintiff’s estate can recover all earning potential that a decedent would have been able to earn and provide if a person who died due to medical malpractice had lived. This is now the law, even if that person was not responsible for the support of anyone else. The Court of Appeals cited the precedent established in Denney v Kent Road Commission. Since that decision, what a decedent’s estate can recover is referred to as “Denney damages.” Cases that once settled for $250,000 are now expected to be resolved for $700,000.

With “Denney damages,” the liability for healthcare organizations increase as earnings can be counted for any victim of medical malpractice, even those who have yet to establish any known talents, educational attainments or trainings typically used to calculate such earnings.

It is important to note that while we engage on this topic in the public policy arena, our ultimate priority is the safety and wellbeing of patients. Our hospitals and providers take the life of each patient in their care extremely seriously and there is nothing a hospital wants to avoid more than a medical error. To that end, we have “put our money where our mouth is” by establishing the MHA Keystone Center, which has become a true leader in this space, both in Michigan and nationally. The Keystone Center, which also operates a federally certified Patient Safety Organization, collects and analyzes data on medical errors and “near-misses,” serving as a North Star in our collective efforts to improve patient safety and quality. Our successes have been well-documented in peer-reviewed medical journals. Blue Cross Blue Shield of Michigan has provided significant funding to the MHA Keystone Center over the years, and so has the federal government through a series of contracts, as they have seen and valued the tangible improvements we have made and will continue to make.

Back to the issue at hand: our hospitals and providers are committed to doing right by patients, through the provision of the highest quality care possible. And for nearly three decades, Michigan’s medical liability laws have proven our system can fairly handle cases of medical malpractice that compensate patients and families fairly while maintaining hospital liability at sustainable levels that do not threaten the viability of an organization due to a single error. The system works and it is our intention to keep it that way.

As always, I welcome your thoughts.

MHA Keystone Center 2021-2022 Annual Report Highlights Collaboration and Partnership

The MHA Keystone Center 2021-2022 Annual Report

The MHA Keystone Center recently released its 2021-2022 Annual Report, which showcases the center’s commitment to working alongside members to improve safety and quality in healthcare. Through support from Blue Cross Blue Shield of Michigan, this report highlights the profound impact collaboration and partnership amongst the Michigan healthcare community can have on Michigan’s communities.

Report highlights include:

  • An introduction to the MHA Keystone Center’s Health Equity Task Force, which was assembled to provide guidance to members in their efforts to redesign and implement interventions that address disparities in care.
  • An overview of the well-being program (WELL-B) launched in partnership with Duke Center for Healthcare Safety and Quality to address workplace burnout in healthcare.
  • A birds-eye view of the collaboration taking place to address increasing opioid use disorder cases.

Printed copies are available upon request.

Members with questions about the report should contact the MHA Keystone Center.

Michigan Healthcare Leaders Speak on Clinical Genomics During White House Panel

MHA EVP Laura Appel joins experts from MDHHS, BCBSM, Michigan Medicine and Beaumont Health

The MHA and fellow healthcare leaders joined a virtual panel discussion on clinical genomics Sept. 22 hosted by the White House Office of Science and Technology Policy and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The purpose of the webinar was to raise awareness about the clinical utility and lifesaving potential of clinical genome sequencing, as well as highlight coverage models for state Medicaid programs and private payors to help enable equitable access.

According to the National Department of Health and Human Services (HHS) and the National Institutes of Health, recent technological advances have made it possible for clinicians to quickly sequence the genomes of critically ill newborns and children to rapidly make a diagnosis. This powerful technology can transform lives by identifying potentially lifesaving and life-changing medical treatment. However, despite the enormous promise of genome sequencing to improve health outcomes, not all patients who might benefit from this technology can access it.

Laura Appel, executive vice president of Government Relations & Public Policy at the MHA, joined the conversation to speak on our state’s model for advancing coverage of genomic sequencing. Other panelists from Michigan healthcare institutions, included:

  • Brian Keisling, director of bureau of Medicaid policy at the Michigan Department of Health & Human Services.
  • Caleb Bupp, M.D., FACMG, division chief of medical genetics & genomics at Beaumont Health Spectrum Health and Helen DeVos Children’s Hospital.
  • Lynne Carter, M.D., MPH, medical director at Blue Cross Blue Shield of Michigan.
  • Wendy R. Uhlmann, M.S., LCGC, genetic counselor and clinical professor at the Departments of Internal Medicine (Division of Genetic Medicine) and Human Genetics at the University of Michigan.

During the discussion, the group touched on Project Baby Deer, an initiative that provides rapid whole genome sequencing testing for critically ill infants up to one year of age. The program can enhance clinical management of young patients by initiating life-saving treatments, avoiding unnecessary tests and procedures, shortening hospital stays and helping families with treatment decision-making.

To learn more about clinical genome sequencing, visit the HHS website. Those with questions about Project Baby Deer may contact Laura Appel at the MHA.