Executive Order Includes Focus on Hospital Mergers; FDA Requests Investigation into Approval of Biogen’s Aduhelm

July 13, 2021 - Happy Tuesday! Folks on either coast of the United States are facing either record high temperatures or levels of rainfall. As is the case most times, meteorologists are the only ones satisfied.

FDA Calls for Federal Investigation into Approval of Biogen’s Aduhelm

FDA has called for a government investigation into the approval of Biogen’s Alzheimer’s drug, Aduhelm, according to multiple news sources.

Experts recently discovered an unreported meeting in May 2019 between a top Biogen executive and the FDA's lead reviewer for Alzheimer's drugs. The meeting came after Biogen pulled Aduhelm after trials showed it might not have much of an effect. FDA interactions with drug industry staff are controlled and carefully documented, so it is unclear if the meeting violated agency rules.

In a letter to the HHS Inspector General, Janet Woodcock, MD, acting commissioner of FDA, requested that OIG conduct an independent review of interactions between Biogen and FDA during the process that led to Aduhelm’s approval. READ MORE

Biden Executive Order to Have Ramifications for Hospital Mergers

An executive order has serious implications for healthcare consolidation, and specifically, hospital mergers and acquisitions.

President Biden signed the executive order on Friday in an effort to boost competition and lower prices for consumers across industries, including healthcare. Specifically, the executive order calls out rising prescription drug and medical device prices because of a lack of competition among manufacturers. But the executive order will also impact another reason for increasing healthcare costs: hospital mergers and acquisitions.

“Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market. Since 2010, 139 rural hospitals have shuttered, including a high of 19 last year, in the middle of a healthcare crisis. Research shows that hospitals in consolidated markets charge far higher prices than hospitals in markets with several competitors,” the White House said. READ MORE

The Critical Importance of Social Determinants of Health

Researchers found that identifying unmet social needs and addressing social determinants of health is necessary for mitigating care disparities and improving health outcomes in certain cancers.

In the study of 135 women with gynecologic cancer at Olive View-UCLA Medical Center, the majority of patients had at least one unmet social need, and a third of patients had two or more. Higher rates of depression and distress were associated with higher numbers of social needs. Assistance with reading hospital materials was the most commonly reported social need.

"While it is not within the power of individual healthcare systems or providers to modify social determinants of health, these data offer hope that we can implement programs to reduce healthcare disparities by addressing unmet social needs," said lead author Abdulrahman K. Sinno, MD. READ MORE

Virtual Care Leads to Satisfied and Engaged Patients

A recent Cleveland Clinic study finds that patients are just as satisfied with virtual visits as they are with in-person care visits.

The survey was distributed to 426 patients who had attended a virtual care visit between June 21 and July 12 in 2017. It sought to collect data on overall patient satisfaction levels, comfort and ease using technology, and patient-clinician engagement.

More than 80 percent of patients agreed or strongly agreed that their virtual visit was as good as an in-person visit, with 53.2 percent indicating that the experience was better than an in-person visit. The majority of respondents agreed or strongly agreed that the virtual visit made it easy to get the care they needed and the visit saved them time (90.9 percent and 91.9 percent, respectively). Most of the patients (92.9 percent) responded that they would attend a virtual visit again for a healthcare need. The average overall satisfaction score, using the Likert scale, was 4.4 out of 5. READ MORE

Employer Health Benefits Evolving for the Better Due to Pandemic

As employers transition their workforces back into in-person or hybrid workplace models, employer health benefits will have to evolve to accommodate mental health needs.

Employees may face stressors such as starting to commute to work again or helping their children transition back to in-person school five days a week. Providing health benefits and services to support employees’ mental health is the top priority for employers at this stage of the return to pre-pandemic activities.

“For employers, it is about trying to support employees to make that transition back to the workplace. Work is likely to be and look a little bit different than it did before the pandemic, as so many of our members have moved employees to remote or hybrid work,” says Brenna Shebel, vice president at Business Group on Health. READ MORE

Gene Therapy Linked to Improved Population Health Management

A study led by researchers at The Ohio State University Wexner Medical Center and The Ohio State University College of Medicine shows that a new method of gene therapy is providing relief for children born with AADC deficiency, which occurs when individuals have an insufficient synthesis of dopamine and serotonin.

Seven children ages 4 to 9 taking part in the directed gene therapy were infused with the viral vector. The results showed a dramatic improvement of symptoms, motor function, and quality of life for the children.

According to researchers, the therapeutic modality shows promise in population health management and patient care for those with AADC deficiency and other similar disorders of the brain in the future. READ MORE