Author Archives: Casey Marson

Private Equity Investment in Healthcare

“Ten years ago, only a few private equity firms had dedicated healthcare components, but today, nearly everyone does” says Dmity Podpolny of McKinsey & Company, one of the largest consulting firms in the world. Private equity and medicine are now on the rise. For years, private equity firms have invested in healthcare. However now, the rapidity is significant private equity firms increase their presence in a compartmentalized healthcare industry, grasping on alliance opportunities to obtain a better business model. PwC Health Research Institute explains that “private equity’s acquisitions and investments in the health sector have become increasingly diversified and frequent; they include such things as new entrants in technology and convenient care delivery, contract research organizations, and ophthalmology and dermatology practices”.

Last year, private equity continued to move into new medical specialties, according to a 2018 report. The report outlined three major points to consider. The third quarter of 2018 saw roughly $30.4 billion in deal volume, rising 8 percent year-over-year. Private equity will likely continue to push into the health sector, specifically in medical specialty practices. Researchers estimate that industry players have roughly one million dollars to invest in certain businesses. The urgent care realm for example, has grown by 5.8% in 2018. PwC notes that due to the high quantities of these deals involving private equity, other firms may make the decision to sell themselves to these private equity groups to better improve their business model.

Moving forward, this means several things. PwC expects this trend to accelerate even more in 2019, giving conventional healthcare companies various opportunities to sell portions of certain “noncore” assets and really focus on their core functions. Alternatively, conventional healthcare companies could partner with private equity in acquisitions, which they would otherwise be competing against or unable to accomplish without the partnership. 

For example, last month KKR & Co., a private-equity firm, entered into an agreement to purchase Envision Healthcare, an emergency department staffing company. The deal was valued at $9.9 billion, including debt. If approved by shareholders, the deal would be the largest in a string of recent health-care investments by KKR. These investments include an ambulance service, a company that helps treat children with autism, and a creator of various medical devices.

What does this mean? Private equity is accelerating change in the industry. “Private equity investment in healthcare isn’t going to single-handedly improve care quality, enhance the patient experience or reduce healthcare costs to consumers,” PwC stated. “But it likely is fueling the efforts already in place.” Private equity firms bring wealth and knowledge from other industries that can contribute to the healthcare industry’s efforts to rein in costs and achieve better outcomes.

Leave a Comment

Filed under Uncategorized

How a Government Shut-Down Impacts our Health

We rang in 2019 with a federal government shut-down. The thirty-five day shut-down commenced at midnight on December 22, 2018.  On January 25, 2019, President Trump declared the government reopened and funded until February 15, 2019. In the wake of our country’s longest federal government shut-down to date, which might not even be finished, we are forced to examine the very real consequences  for citizens during such times.

            The effects of a long-term federal government shut-down are insurmountable. The recent shut-down impacted the Food and Drug Administration (FDA) in many ways. The FDA is a crucial player when it comes to medical products, drugs, and food safety. The recent shut down certainly effected the FDA’s ability to operate wholly, and subsequently put our country’s health at risk.

            Thousands of FDA employees considered non-essential were furloughed and the FDA had to pause routine regulatory and compliance activities. For instance, during the shut-down, the FDA was unable to accept new medical product applications that required payment or to review drug applications that were not user-funded. Applications typically take several months to review. The FDA’s Center for Drug Evaluation and Research was forced to put all non-emergency over-the-counter monograph drug activities on hold because they were determined not to address immediate threats to human life and safety. More than ten drug makers were expecting  FDA decisions in March, weeks after the agency was expected to run out of money. During the shutdown, the FDA used carryover “user fee” subsidies to resume review of certain applications that required a user fee, such as New Drug Applications, Biologics License Applications, and Premarket Approval applications for medical devices if the fee had already been paid. Still, the FDA was unable to accept new user fees during the shutdown. If fee payment was required, sponsors had to postpone review until the government reopened. Some companies and industry segments, such as allergenic products, discussed  excepting user fees and chose to rely on budget authority. Thus, when budget authority lapsed, assessment for those products ceased, unless review was warranted because there was an emergency involving the safety of human life.

FDA foreign food inspections continued, almost normally, because they were considered essential. But the FDA basically had to stop inspecting domestic food production facilities during the shut-down. This means threats to the public, like bacteria outbreaks, were potentially going undetected. Much of FDA’s funding appropriated by Congress was put on hold. Therefore, decisions had to be made based on an analysis of importance and imminence. The most urgent inspections would be at facilities with prior safety issues, such as factories with listeria, salmonella contamination, or other hygienic problems. Next came foods that were more prone to contamination. For example, cheese might be a high-risk food, and a facility that manufactures crackers would be low risk, according to Scott Gottlieb, commissioner of the FDA.

Besides the logistical issues of ranking tasks by importance, he went on to explain how difficult the circumstances were for the employees. “We are trying to build accommodation in for people who have unusually difficult circumstances,” Gottlieb said.

            As we approach mid-February, time will tell how President Trump’s three-week plan went, and what is in store for the FDA and our health moving forward.

Leave a Comment

Filed under Uncategorized

History Repeating Itself: The FDA’s Response to a Dangerous New Trend

For at least the last decade (as long as I can remember growing up), the health risks of tobacco and smoking cigarettes were obvious.  The movement to raise awareness about the dangers of smoking was well underway, as television commercials, printed advertisements, and teachers were educating young people about nicotine’s addictive qualities and the link between smoking and certain cancers.  Growing up in the 1990s–2000s, there was no doubt in our minds smoking was bad.

As times progress, obviously so does technology.  Every day it seems like technology endlessly advances as new and better gadgets hit the shelves. Better phones, better cameras, everything.  Now, however, the tobacco industry has intersected with the tech industry as the popular e-cigarette, or Juul, has gone viral. You likely see people smoking these thumb-drive looking gadgets on a daily basis.  Juul, as a company and brand, does not hide that their products contain nicotine and that nicotine is an addictive substance.  They market themselves as the first viable alternative for adult smokers. Their website even warns “smoking is bad for your health, and those who don’t currently use nicotine products should not start.” Even with this effort to promote safety and health, the e-cigarette craze has brought with it a great deal of health problems and arguably caused new risks rather than merely creating an alternative to old ones.  Why is it that young people, who have always known the dangers of cigarettes, start using the Juul?  Is it Juul’s marketing and targeting techniques?  Is it our inherent need in 2018 to have the newest, coolest technology?  This, of course, is hard to say.  But the problems are real, and the FDA has now stepped in and has particularly focused on Juul’s risks towards young people.

So, what is a Juul and how is it different from a cigarette? The Juul is a compact, USB-shaped vaping device. It is similar to other e-cigarettes, says cardiologist Holly Middlekauff, M.D., professor of medicine and physiology at the David Geffen School of Medicine at UCLA.  “The liquid is pretty much the same. It has solvents, nicotine, and flavorings,” Middlekauff told MensHealth.com. The solvents help deliver the nicotine and flavors in the form of tiny particles into the lungs. Unlike other e-cigarettes, the Juul is compact and rechargeable; and additionally has an internal temperature-regulating mechanism that prevents it from overheating or even exploding. The Juul has become particularly popular on social media, especially among young people. But as trendy as it is, the device still contains nicotine and is a major health concern, say medical experts.

In April 2018, FDA Commissioner Scott Gottlieb announced that he was forming a Youth Tobacco Prevention Plan aimed at stopping youth tobacco usage.  The FDA led a surprise inspection of the headquarters of Juul Labs in late September, retrieving more than a thousand documents it said were related to the company’s sales and marketing practices.  The FDA said it was particularly interested in whether Juul deliberately targeted minors as consumers.  “The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens,” the FDA said in a statement. “It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”  The agency has given Juul and four other e-cigarette manufacturers a 60-day deadline to produce plans showing how they will limit access to teenagers.  It will certainly be interesting to see if this trend will go out of style soon, or if the FDA will need to take further steps to re-teach our youth the dangers of nicotine and cigarettes.

Leave a Comment

Filed under Uncategorized

What Could Brett Kavanaugh do to Women’s Health Law?

President Trump’s Supreme Court nominee, Judge Brett M. Kavanaugh, has been a constant conservative presence on the United States Court of Appeals for the District of Columbia Circuit for twelve years.  Judge Kavanaugh has made it a point to stress textual limitations of the Constitution while often supporting corporations over regulators, and the government over individuals claiming violations of their rights.  With seldom exceptions, his position is to the right.  With his nomination, Americans are concerned that long standing precedents may be overturned, and Kavanaugh’s appointment could mean huge changes especially when it comes to women’s health.

When President Trump nominated Judge Kavanaugh on July 9, 2018, the President spoke highly of him as a person, a father, and a judge.  Judge Kavanaugh has stated that he had no intentions of overturning Roe v. Wade precedent during yet has eluded to a narrower interpretation  of when a woman can exercise that right.  In this time of “fake news,” a term coined by the President himself, it is unsettling as a woman to trust Kavanaugh’s statement as a promise.  His actions and opinions thereafter have raised even more concern.

In a notable decision in the fall of 2017, the DC Circuit voted to allow an undocumented pregnant seventeen year-old girl in an immigration detention center to obtain an abortion without delay. Judge Kavanaugh dissented.  He noted that while the Court of Appeals was obliged to follow Supreme Court rulings that recognized the Constitutional protection of a woman’s right to choose an abortion, those precedents left room for the government to apply “reasonable regulations that do not impose an undue burden.” Judge Kavanaugh sided with the Trump Administration, who argued that the young women should first be transferred to an adult sponsor for guidance, and argued that it was reasonable to choose a transfer to a sponsor instead of “forcing the minor to make the decision in an isolated detention camp with no support network available. . . . The majority’s decision represents a radical extension of the Supreme Court’s abortion jurisprudence,” he wrote.

Many Democrat political figures, like Elizabeth WarrenJeff Merkley, Dianne Feinstein, and Kamala D. Harris have expressed their grave concerns with a Kavanaugh appointment and made it clear that, in their opinion, Judge Kavanaugh does not intend to maintain Roe v. Wade precedent.  Senator Harris said, in response to Judge Kavanaugh’s remark equating birth control to “abortion inducing drugs,” tweeted on September 7, 2018, “Kavanaugh chooses his words very carefully, and this is a dog whistle for going after birth control. He was nominated for the purpose of taking away a woman’s constitutionally protected right to make her own health care decisions. Make no mistake – this is about punishing women.”

As disconcerting as anything unknown, only time will tell if Judge Kavanaugh will be given Supreme Court decision making power with the hearings on the sexual assault allegations delaying the vote.  In moments like these, it is paramount we realize how influential these types of nominations and appointments can really be in our country.

Leave a Comment

Filed under Uncategorized

Access to Mental Health Care in Prisons

Mental illness continues to be stigmatized in the United States, making it difficult for people to discuss and to pursue help. Like mental health, incarceration is a branding topic that often carries with it negative connotations and judgments. Both of these matters are significant and deserve research, awareness, and reform alone; however, the issue of mental health in prisons is one that encompasses both of these issues and must be addressed. The lack of access to services for incarcerated individuals is devastating.

One of the main objectives of incarceration is isolation and separation from the outside world. Because of this, the institutions must provide their inmates with everything essential like food, water, bedding, etc. At what point does the law draw the line between what is essential and what is not? What does this mean for mental health?

The U.S. has the highest rate of adult incarceration among the developed countries, with 2.2 million currently in jails and prisons. Those with mental disorders have been increasingly imprisoned over the last thirty years, most likely due to the deinstitutionalization of the state mental health system. Correctional institutions have become de facto state hospitals, with more seriously and persistently mentally ill inmates in prisons than in all state hospitals in the United States. In cases like Ruiz v. Estelle, U.S. courts have clearly established that prisoners have a right to receive medical and mental health care.

In order to meet this need, it is important to examine options and solutions inside the prisons. Often, state correctional departments have agreements with state departments of mental health to have professionals come into the prisons and provide acute care. Having these mental health professionals come to prison helps address many issues including the lack of ability to transport inmates to outside facilities, understaffed and under trained prison personnel, and lack of resources in general.

Suicide is the third leading cause of death in U.S. state and federal prisons. Suicide-prevention programs in prisons are of increasing importance to mental health professionals, correctional administrators, health care providers, legislators, attorneys, and others as they seek to rehabilitate offenders and avoid the multi-million dollar lawsuits that result from inmate suicides. Suicide prevention efforts must extend beyond the mental health staff of prison facilities, and begin to include guards, administrators, and custodial staffs.

Another important measure is a change of perspective on punishment as a whole. There has been an increase in the use of diversion programs such as mental health and drug courts across the country. These courts work with mental health and substance abuse treatment providers to assist those who struggle with these problems. In order to participate in this treatment alternative, a person must first plead guilty to a crime and be subject to incarceration. Although these alternative routes have many advantages and a great focus, evaluations of mental health and drug courts have shown questionable success and significant challenges.

Another alternative is the use of pre-booking diversion. A pre-booking diversion plan is is one that identifies low-level offenders and redirects them from jail and prosecution by providing linkages to community-based treatment and support services. This alternative requires the efforts of both a law enforcement and social services. When possible, individuals who do come in contact with police should be diverted to other options like treatment before they are ever faced with arrests, charges, and sent to the police station for booking.

Overall, the need for prison-based mental health treatment is profound. It is important we focus our efforts inside the prisons with the staff, health care providers, and inmates in order to create a safer environment. It is also important we move away from the system of punishment, and instead consider alternatives to incarceration in order to rehabilitate and prepare these individuals for life in the community.

Leave a Comment

Filed under Uncategorized