Volume 3

Happy Wednesday! Over the past week, healthcare news has been dizzyingly fast and consequential. As always, I’ve highlighted the Top 10 things you need to know that could affect your team, patients, your business, and even your health.

In this week’s issue I’ve included information on: COVID and the return to normalcy, a new emerging global threat- Monkeypox, continued supply chain disruptions, and digital health trends. For deeper dives, click on the hyperlinks in summaries! Also, don’t forget to hit me up on social media at LinkedIn or Twitter!

1. The Federal Declaration of the Public Health Emergency (PHE) Continues

As COVID cases continue to increase with a new variant, the Biden administration has declared the continuation of the COVID-19 public health emergency. This allows people to acquire vaccines, COVID-19 testing, and treatment for free along with expanded health insurance coverage to more than 11 million Americans and access to telehealth services. With the PHE extension, the declaration will continue at least into the fall of ’22, giving states and the federal government the time and resources needed to prepare for further COVID surges.

So What’s The Big Deal? Allowing the PHE to lapse could have significant economic impacts on the out-of-pocket expenses for patients. As a result, revenues for hospitals and other healthcare entities could decline. Additionally, new technologies and services supported by telehealth could be forced into a pre-COVID regulatory environment, limiting further innovation and potentially limit present use.

2. COVID Cases Climb in Every State Thanks to BA2.12.1

Except for Maine, every state across the US has reported a rise in the number of COVID cases and hospitalizations. While Americans are more concerned, there has been little to no change in their behavior towards the spread of the virus.

So What’s The Big Deal? We are in a surge and cases are growing rapidly. Hospitals must prepare now for an early summer and late fall surge in COVID. Authorities recommend the implementation of flexible mitigation guidelines, expanding booster use, and the use of protective gear (PPE) to limit the spread of infections and reduce the healthcare burden.

3. The FDA Authorizes Boosters for Children Ages 5-11 and Pfizer Announces a Vaccine for Children Under 5.

The Food and Drug Administration and CDC has authorized the administration of a third dose of the Pfizer COVID-19 vaccine for children ages 5-11 after a minimum of five months after the administration of two primary doses.

Also, Pfizer released data on their vaccine for children ages 6 months to 5 years, demonstrating 80% efficacy against COVID19 infection. The FDA plans to review Pfizer and Moderna’s vaccine data in June.

So What’s The Big Deal? The data from Pfizer and the FDA’s approval of boosters are promising. Reducing childhood COVID cases with vaccination is a critical component to protecting the health of children and adults by reducing overall virus circulating. With more children vaccinated, the disease burden in communities will fall, driving down overall infections and variants.

4. Monkeypox Cases Continue to Rise

Over hundreds of confirmed cases of Monkeypox have been found in countries around the world. While relatively uncommon and less severe than the deadly Smallpox, Monkeypox is rarely seen outside of localized outbreaks in Africa. Now, however, the virus appears to have mutated and is transmitting between humans (rather than between rodents and humans). Transmission occurs by close contact with an infected individual or their clothing.

In Africa, Monkeypox has a death rate between 3-6% depending on the strain and has been found to be more severe in children. Fortunately, scientists have effective vaccines for Monkeypox but those vaccines are not widely distributed to local clinics or healthcare facilities.

Very few members of the world’s population have been vaccinated against the disease since widespread vaccination for Smallpox (and by extension Monkeypox) hasn’t occurred in over 50 years. Launching a broad vaccination campaign could prove to be challenging.

So What’s The Big Deal? It’s still too early to know exactly how severe Monkeypox will be for the general population; however, Monkeypox transmitting between humans is concerning and not common. Scientists and healthcare professionals are watching the situation closely to determine if viral mutations have made the virus more severe (or less) and more easily transmitted. For more details: click here or check the infographic below.

5. Biden Invokes the Defense Production Act for Baby Formula

To address the shortage of baby formula across the country, President Joe Biden invoked the Defense Production Act to promote the production and supply of baby formula. In addition, Biden also initiated a program involving the use of US military aircraft for importing ingredients and formula from abroad. This will ensure that manufacturers have a sufficient supply of both. As of today, formula is now arriving in the US from Europe via Operation Fly Formula.

So What’s The Big Deal? The US baby formula shortage is a symptom of a growing supply chain problem. With continued global supply chain issues, there are significant vulnerabilities in critical food and medical equipment supplies (see #6) in the US. Irrational demand behaviors, market consolidation, poor trade policies, COVID, and manufacturing monopolies all contributed to the crisis.

The supply chain crisis is far from over. Government agencies (HHS, DOD) should identify critical vulnerabilities now and prepare.

6. Supply Chain Issues with IV Contrast Dye and COVID Medications

The establishment of COVID lockdowns in China has affected the operations at the General Electric plant in Shanghai, substantially reducing the production of a dye used in medical scans. Intravenous (IV) contrast dye is integral to the diagnosis of tumors, strokes, heart attacks, and blood clots to name a few. The shortage of dye and the use of alternative diagnostic tools has creating a ripple affect, leading to indeterminate diagnoses, misdiagnoses and delayed diagnoses of various conditions.

In addition to IV contrast dye materials becoming depleted, the reserves of COVID-19 medications, medical plastics, and other medications are gradually falling as a result of supply chain disruptions.

So What’s The Big Deal? COVID19 continues to affect global supply chains due to factory closures/disruptions in other parts of the world. Medicines and medical/diagnostic equipment are not immune. With disruptions likely to continue, hospitals and clinicians must consider contingency plans.

7. Oklahoma Bans Abortion Stating Life Begins at Fertilization

Oklahoma's legislature passed one of the country's strictest abortion bills, stating that life begins at fertilization. The legislature also allowed OK citizens to sue abortion providers and prohibits abortion at any pregnancy stage. There are a few exceptions — medical emergencies and incest and sexual assault if reported to law enforcement. Since the law is a state law, abortion providers at federal facilities cannot be sued. While not explicitly stated, the bill's sponsor, Wendi Stearman, states the bill does not discourage any forms of contraception.

So What’s The Big Deal? Beyond restricting and deterring abortion, defining life at fertilization could have far reaching implications for contraception, fertility treatment, and even “fetal” rights. Since fertilization occurs before implantation and some contraceptives (ex: IUDs) and procedures depend on in vitro fertilization (IVF), the law could create further restrictions outside of abortion or become a deterrent for clinicians who practice reproductive health or treat miscarriages.

8. High Valuations for Digital Health-Tech Companies are Cooling

The CEO of Oscar Health, Mario Schlosser, states that the high valuations for digital health companies are cooling.

Investments and money funding deals were relatively fewer this year as compared to 2021. Despite the valuation trends, digital health leaders have become increasingly confident about the role of digital health in transforming healthcare. Irrespective, this “cooling-off-period may force companies to become more efficient and develop more realistic economic models.

So What’s The Big Deal? The pandemic injected significant cash and promise into the digital health market as patients left brick-and-mortal practices for the convenience and safety of home. However, other macroeconomic factors are now coming into play with digital health companies. Some analysts believe valuations in digital health companies could be on the verge of a bubble.

9. Prescribing practices for telehealth companies comes under greater scrutiny

Telehealth company, Cerebral, comes under a Department of Justice investigation for “possible violations” of the Controlled Substances Act. Under their business model, Cerebral prescribed controlled substances like Xanax and Adderall (both highly addictive, controlled substances) to patients using their online evaluation platforms. Some have alleged that Cerebral (and other companies like it) are prescribing drugs of abuse to patients without the proper oversight and clinical evaluations.

In some reports, clients created false accounts to get large numbers of controlled medications for abuse and misuse. As of last week, the companies CEO Kyle Roberston has stepped down and Cerebral shifted their business model. The company now states they no longer prescribe most controlled substances.

So What’s The Big Deal? Digital health enabled prescribing has been virtually unregulated (pun intended). As a result, many worry that patients have been able to use the services as pseudo-pill mills for controlled substances. Action (or inaction) by the DOJ could change the service offerings and regulations associated with prescribing controlled substances including patient safety implications. Depending on the results of the investigation, telehealth company valuations that focus on ADHD, psychiatric, and chronic pain management could have significant financial impacts.

10. Billions in Federal Funds Continue to Support Rural Hospitals

With the declaration of the COVID-19 pandemic, rural hospitals across the nation have received billions of dollars in federal funding, enabling these facilities to provide healthcare services to critically ill patients. However, the funding does not address the financial crises the hospital faced before the pandemic and may face after the pandemic once some the federal funding dries up. To address the issue, the director of the Center for Healthcare Quality and Payment Reform (a non-profit, national policy center) Harold Miller, proposes that rural hospitals should receive a fixed payment to provide the critical services along with regular reimbursements from the insurance providers.

So What’s The Big Deal? Rural hospitals could have significant financial troubles as COVID funding declines and private payer reimbursements fall. If public and private funding declines, closures could follow. Hospital closures and loss of healthcare services could widen the gap in healthcare access and outcomes of many rural communities.

Let’s keep the conversation going and have a wonderful rest of your week! - Dr. Adam Brown

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