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Wake Up Call to Congress: It’s Time To Deliver on Healthcare, For my Patients, and For my Child….

Kevin R. Campbell, MD, FACC

CEO, K-Roc Consulting LLC

I am a physician and a father of a child with a chronic disease. I practice in rural North Carolina and many of my patients cannot afford the care that they need. Most do not have adequate access to preventative services and many must choose between purchasing medicines or purchasing food. The Affordable Care Act (ACA) has made little difference in the lives of my patients—I have seen no improvement in coverage or in their ability to afford care. My child is 16 years old and has had type one diabetes since age 5.  My child is dependent upon insulin, an insulin pump and numerous diabetes supplies—totaling thousands of dollars every month—for life.

What happens to my child when I am gone? How will my diabetic child be insured and cared for?

Throughout the election of 2016, Republican candidates (at all levels) made promises about healthcare. Most Conservatives agree (and some Democrats will admit) that the Affordable Care Act (ACA) must be significantly amended in order to provide high quality, easily accessible, affordable healthcare to all Americans. In the last year, multiple insurers have pulled out of the exchange markets and premiums are rising in most states. Many of those who are “newly-insured” are insured only on paper—most have little or no access and many have very limited choices.

President Trump and the Republicans in Congress vowed to make healthcare reform a priority and promised new legislation within the First 100 Days. However, infighting within the Party as well as political posturing by Democrats have resulted in little or no progress. The first Republican proposal—due to major disagreements among legislators—was never even brought to a vote. Now, a new draft proposal–known as the McArthur amendment to the American Health Care Act–has been released. And I thought healthcare could not get worse…..

In the latest iteration, the act would provide for essential healthcare benefits from the ACA and would mandate coverage of pre existing conditions. However—it would also allow the States to apply for exemptions—effectively allowing States to take these provisions away. This would leave millions without care.

As a physician, it is vital that I am able to care for my patients. People must be given access and choice when it comes to healthcare. The ACA, nor the American HealthCare Act with the McCarthy amendment will accomplish these goals. Obamacare will eventually become non viable. Congress must find a real solution—whether we repeal and replace or amend the current act is immaterial to me.

While I am NOT a supporter of the ACA, there are a few key components that make a great deal of sense and, in my opinion, MUST be part of any new healthcare bill:

  1. We MUST cover Americans with pre-existing conditions. We cannot allow insurers to charge those with chronic disease higher premiums and effectively “price them out of the market”. My child has type 1 diabetes—an inherited disease—why should my child suffer due to an inability to afford insurance later in life? She did nothing to deserve the diagnosis and works diligently every day to control her blood sugars and effectively manage her disease.
  1. We MUST allow those 26 and under to remain on their parents insurance plans. This will allow these young people to continue to fund and education and begin a career. Why should we ask for young, healthy young adults to foot the bill for elderly, sick Americans when they are trying to build their professional lives through education and hard work?

In addition, I believe that any viable healthcare replacement bill must also include the following provisions:

  1. We MUST allow insurers to compete across state lines. Free market competition is likely to improve the quality of service and will lower costs. There is no reason why choices should be limited in a particular state simply because there is only one or two insurers operating in that location.
  1. We MUST allow Americans to purchase pharmaceuticals abroad. Currently, the US bears nearly all of the cost of research and development for the world. Our drug prices are significantly higher than in any other developed nation. There must be consequences for predatory pricing by pharmaceuticals and CEOs such as Heather Bresch of Mylan and Martin Shkreli must be held accountable for their actions

Its Time For Members of Congress To Make Good On Their Promises…..

Speaker Ryan and the House Republicans need to compromise within their own Party now or they will suffer the consequences in the midterm elections. The childish bickering between the Tea Party, Freedom Caucus and the rank and file Conservatives must end. The Democrats need to begin to come up with viable solutions to the healthcare crisis as well. Its time to stop hanging on to the “Camelot” vision of Obama’s signature legislation and get to work. Neither party is without blame.

To those in Congress, I say it is time to ACT. Think of those that are suffering with curable and treatable illnesses that have no access to care. Think of my child—think of your own children—and work to put together a sustainable healthcare plan for generations to come.

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Where is the accountability? The FDA confirms that St Jude Medical Put Profits Ahead of Patients—-

Dr Kevin R Campbell, MD, FACC

Over the last year, St Jude Medical was involved in a major acquisition deal—one that amounted to nearly 25 billion dollars—with Abbott. The timing of the deal was difficult for St Jude as the company was in the middle of two major product safety issues during the period that the stock price was being negotiated. Certainly, any major flaws in their devices would have been costly to both shareholders as well as the St Jude Medical executive team as it may have significantly devalued the company prior to the close of the deal. In the last week, we have all learned some disturbing facts–about what the company knew and when they knew it—from publicly available FDA documents.  The New York Times also published an investigative report and summarized the events of the last year on Friday of last week.

What Were the Product Safety Issues?

Without going into detail (you can find these on my published links that are embedded within the article), SJM had first navigated a major lead recall issue in the prior years and was now dealing with two new product related safety issues.

(1) First there was an issue with premature and sudden battery failure—that resulted in patient deaths—due to the formation of crystals within the battery itself (bridging cathode and anode) that ultimately led to premature energy depletion. The company initially reported that the analysis of these failed batteries were inconclusive and that the deposits may or may not have been the culprit.  It is speculated that the company began to receive reports concerning the formation of battery crystals as early as 2011.

(2) There was also an issue with the security of data from the remote follow up devices—cyber security experts claimed that St Jude Devices were uniquely vulnerable. A third party analysis was brought to the attention of SJM management.  The company vehemently denied any security vulnerabilities, yet only days after the Abbott acquisition, a “security patch” was delivered remotely to all patients with active monitors.

The deal ultimately closed as planned in January 2017—and according to public records, key players from St Jude Medical made a great deal of money once the deal closed….But some patients with SJM devices were dying.

 I Think I (and other thousands of other doctors) May Have “Been Had”

I initially wrote about my concerns surrounding the management of significant ICD battery issues as well as other concerns over the online cyber security of the St Jude Medical home monitoring system known as Merlin at home. After publishing these pieces I was able to speak with Dr Mark Carlson from St Jude Medical and wrote a follow up piece based on the story (and timeline of events) he shared with me.  The description of events from the SJM perspective seemed to make sense at the time.

Now, the truth is beginning to emerge. It appears that the company knew of a death related to the battery issue and did not share the information with the medical advisory board. St Jude Medical continued to sell these devices and—unknowingly—physicians such as myself—continued to implant them. While St Jude Medical was aware of the potential issue in 2014 and changed the manufacturing process in 2015–they did not reveal the issue to implanting cardiologists until October of 2016.  In fact, these devices remained in circulation and at least seven of these defective devices were still implanted, even after the recall.

As a physician, it is my job to provide proven treatments for my patients. During the time that these faulty devices were being supplied to us by St Jude Medical, our patients trusted us to do our best for them, and we trusted our device makers to provide us with the very best technology available. Now it is estimated that nearly 200K patients have these recalled devices. At this point, most experts—including the FDA—believe that the risk of replacing these devices appears to outweigh the benefit so most recommend that we closely monitor these patients and their devices. Unfortunately, St Jude Medical is not alone. Years ago, Guidant—now Boston Scientific—was found to be guilty of allowing devices that they knew were faulty to be sold and implanted into patients.  These events make one wonder…What else has been covered up over the years by the medical device industry?

So, Did St Jude Medical and Others Place Profits Before Patients? Sure Sounds Like It to Me…

At this point—in my opinion–there has been no real accountability in the medical device industry. Those that profited in the Guidant debacle years ago have long since retired to lives of sizable wealth without a thought to the thousands of patients they harmed. The patients that were intentionally put at risk through omission and deception—all in the name of a stock price–are long gone.  While Guidant was fined a significant amount of money, those in leadership positions within that company at the time of the infractions, had long “cashed out” their stock options.

In the case of St Jude Medical—now Abbott—it appears to be business as usual. The only reason we are hearing more today is because the FDA finally looked closely at the timeline of events and the available data and have begun to find significant irregularities in the way in which the company handled safety issues over the last several years. Based on the letter issued last week from the FDA these problems must be addressed in the next 15 days. But does that really matter? Those at the top continue to accumulate wealth and physicians, patients and families are left to deal with the fallout of corporate greed.

It is time that we hold industry accountable for their actions. As a physician and patient advocate, I can no longer sit by and watch this happen. I, along with many of my colleagues, implanted devices in 2015 that had potential flaws—known only to St Jude Medical. I am angry—I feel betrayed by the company and I hope that the FDA and Congress will begin to look closely at these types of business practices. We must not allow ANY medical device company to put the price of a stock or the quarterly profits ahead of patient safety.

It is time for a change. If more regulation is needed, then so be it. Medicine is a noble profession—and the manufacturing of medical devices SHOULD be a noble mission as well.

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Photo taken by Dr Kevin Campbell at FDA campus, June 2016

Note to Congress–You Reap What You Sow—Massive Physician Shortages Predicted by 2030

 

Dr Kevin R. Campbell

Cardiologist and CEO, K-Roc Consulting LLC

When you go to the internet or phonebook today, there are hundreds of physicians listed in most urban areas. In the next two decades, you can expect more difficulty finding a physician in your hometown– a major physician shortage is looming.

In the last year, I have noted many mid career physicians leaving the practice of medicine. While the growth of mid level hospital administrators has ballooned at nearly 3000%, fewer students are entering medical school. In fact, according to Compdata surveys, hospital administrators now account for a large proportion of the costs of healthcare.

The pending physician shortage will affect both primary care as well as numerous essential subspecialties. When I was in medical school, I was told that specialists—such as cardiologists—would be in abundance and I would not be able to get a job. I have been a practicing cardiologist for almost 17 years now. Based on the current report it is expected that we will see a shortfall of nearly 100K doctors by the year 203. A closer look at the predictions show that we will have a shortage of 40K physicians in the critical area of primary care as well as a shortage of nearly 60K physicians in specialties such as allergy and immunology, cardiology, gastroenterology, and infectious disease. In general surgery, the report predicts that there will be 30K fewer surgeons than are needed to provide care to those who need it.

Why Are Doctors Leaving Medicine?

A 2016 report from the Physicians Foundation found an alarming growth in burnout and dissatisfaction among practicing physicians—47% of respondents in the survey indicated plans to “accelerate” their retirement and move into areas outside of clinical medicine. The most common reason for leaving medicine included regulatory burdens and electronic health records. Nearly 63% indicated that they have negative feelings about the future of healthcare and only half of all physicians would actually recommend a career in medicine to their children. Many of my colleagues feel that they have no voice and have no way to impact healthcare policy—even in their own institution.   As regulatory requirements and non clinical tasks continue to mount, physicians are finding themselves spending less and less time with patients. According to 2016 research from the Annals of Internal Medicine, most doctors only spend 25% of their day engaging with patients—the bulk of the time is spent on non-clinical electronic and regulatory paperwork. IN fact, for every hour of direct patient contact, physicians have and additional 2 hours on electronic paperwork.

What is the Solution?

These statistics should be incredibly troubling for all Americans seeking healthcare. With access already an issue in the US healthcare system for many and more reforms on the way, we must do more to entice bright young minds to medicine—and retain those that are currently delivering care to millions of patients.

While the AAMC (American Association of Medical Colleges) argues that the answer to averting a shortage lies in creating more training spots and allowing advanced practice nurses and Physician Assistants to do the work of trained physicians—I would argue that the real answer to the pending physician shortage crisis—unfortunately–lies in Washington DC. Congress must act to save healthcare.

  1. Limit Meaningless Electronic Paperwork

Currently doctors spend far too much time with electronic medical records EMR). The EMR, while touted to be a patient safety tool is nothing more than a way for hospitals and healthcare systems to ensure that they are billing patients at the highest levels—capturing all possible charges. Physicians are forced to click through a myriad of pathways in the record in order to document their care and work and all of these pathways are carefully designed to maximize billing codes. Most doctors take home 2 or more hours of electronic documentation nightly in order to keep up with patient care loads. We must streamline paperwork and balance documentation with patient care. Doctors should not be billers and coders for the healthcare system.

  1. Remove Hospital Administrators from the Care Equation

In some institutions, there are more mid level managers than physicians. These executives are not physicians and are not trained in the practice of medicine. Their primary focus is to increase market share for the healthcare system and to “manage” healthcare professionals by creating algorithms of care and regulations. Administrators will claim that their activities will help with quality improvement and patient safety. However, most of these individuals are highly compensated and I am not aware of any data that suggests that their activities have ever been shown to improve patient outcomes. For most physicians, administrators are a mechanism for increasing cost of care. Physicians should be part of the decision making process in any healthcare system and should have a voice—currently there are very few physicians in the C-suite.

  1. Remove Barriers to Patient Care

Nothing frustrates doctors more than not being able to provide care to patients. We must make healthcare more accessible and provide physicians with the resources they need to efficiently provide high quality affordable care. We must promote the use of telemedicine and digital tools to enhance the doctor patient interaction. We must allow physicians and patients to build long term relationships and facilitate and promote engagement. No longer can we allow networks and insurers to dictate which doctor a patient can see—“if you like your doctor, you can keep him/her. “

  1. No Longer Allow Insurance Companies to Dictate Care

As a practicing physician, I spend a great deal of time battling with insurance companies over appropriate care for my patients. I find myself spending hours each week on the phone with an insurance company bureaucrat arguing that a particular test or therapy is indicated (even though these are supported by clinical guidelines) rather than caring for patients. We must not allow insurers to dictate how highly trained physicians should care for their patients. Insurers must abide by the practice guidelines and indications for tests and procedures that have been approved by major national organizations such as the American College of Cardiology, for example.

 

 

 

There Is No Need to Make a Choice, Representative Chaffetz: Mobile Phones ARE The Future of Healthcare—

This past week Utah Republican Jason Chaffetz made comments concerning healthcare reform that illustrates JUST how out of touch Congress is with modern medicine. In a press conference addressing the ongoing debate over Obamacare repeal, he stated that Americans should make a choice between purchasing health insurance and an iPhone—in the Congressman’s own words “rather than getting that new iPhone that they just love…Americans should invest…in their own healthcare.” As expected, Chaffetz was met with sharp criticism for comparing the cost of a phone to the cost of healthcare. However, I think that most everyone missed the real fallacy in his statement—iPhones and other mobile devices can be a real asset to managing chronic disease and ARE now beginning to be an integral part of healthcare. Rep Chaffetz should learn more about healthcare before he and his colleagues begin to try to create sweeping reform. For instance—ask doctors and patients what is most important to THEM and work WITH us to create meaningful reform. Statements such as the iPhone comments demonstrate JUST how LITTLE Congress really knows about the nuts and bolts of healthcare.

The Digital Revolution in Healthcare: Improving Outcomes and Cutting Costs

Engaging patients in their own care through individual accountability—a sentiment that Rep Chaffetz actually got right (in a roundabout way)—has been shown to improve outcomes. When patients actively participate in their own healthcare and understand the goals of therapy, they tend to experience fewer hospitalizations and fewer complications related to their chronic diseases. Fewer hospitalizations and fewer complications result in much lower healthcare costs.

Physicians are now prescribing apps for tracking blood pressure, activity, heart rate and blood pressure—just to name a few. Other applications such as MyRxProfile are being used to help patients monitor for adverse drug interactions—a leading cause of Emergency Room visits in patients over the age of 65. All of these applications can potentially help patients and physicians focus on PREVENTION—ultimately saving healthcare dollars. New devices are being created every single day to incorporate smartphones into collecting important medical and biologic data. For example, the AliveCor device allows patients to get a real time Electrocardiogram (EKG) simply by touching their fingertips to and electrode that is installed on their smartphone—often obviating the need for an ER visit or hospitalization. Apple’s Health Kit is now being used to help encourage medical app development and to collect important health and wellness data. In addition, Apple’s Research Kit is being used for important groundbreaking medical research by several leading academic medical centers across the United States. Patients are more internet-savvy and many come well prepared to office visits armed with information obtained from the internet. According to the Pew research center, nearly 75% of all patients go to the internet either before or after a visit with their healthcare provider. These patients—now called “e-patients” are well connected, well informed and digitally proficient in the healthcare space.

So Rep Chaffetz, Learn from Doctors and Patients—iPhones are PART of Healthcare…

It is my hope that Congress—both Republicans and Democrats–will stop the fighting and political posturing and do their jobs. They must stop grandstanding and making daily speeches aimed at providing soundbites and creating a media buzz. EVERYONE in Congress must work together to create legislation that will provide high quality, affordable and accessible healthcare for all Americans. There is no longer any place for comments such as those from Chaffetz and his colleagues in a discussion of meaningful reform. We must embrace technology and promote its use among our patients. As doctors become increasingly overwhelmed by paperwork and other mandated clerical activities, it is essential that we continue to develop digital tools to assist and engage patients in the management of their diseases. SO, in my view, you should be able to have your healthcare….and your iPhone too!

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Changing the Focus of Healthcare: From Treatment to Prevention

Too often, the practice of medicine in the United States is focused on treatment. Doctors are taught to battle disease and treat chronic illness to the bitter end, and we have amazing technologies and treatments that have been proven to save lives, but our costs and health outcomes don’t seem to match what we pour into the system.

But what if we doctors changed how we think about battling disease? What if we focused on prevention, rather than treatment? What if our goal were to put ourselves out of business?

That’s where more of our health care tax dollars should be directed — and Dr. Tom Price, the Georgia congressman who was confirmed as secretary for health and human services last night, agrees.

Price, an orthopedic surgeon,  understands the relationships doctors and patients must develop. He’s experienced the frustrations of the current American health care system, and he knows patients are no longer the center of the health care debate.

He has fought on behalf of patients with insurers, taken care of those without insurance and seen firsthand the devastation preventable disease can have on patients and their families.

Under our health care system, government organizations such as the U.S. Preventative Task Force (USPTF) can set policy and greatly influence how physicians practice. Their recommendations directly affect reimbursement and help determine what tests and procedures CMS and Medicare will cover. Dr Price has been outspoken against their recommendations throughout his career—particularly when it comes to the latest recommendations for breast and prostate cancer screening.

For example, though screening for breast cancers clearly lowers risk for death, recent recommendations have made screenings optional for women under 50 and on an every-other-year basis for those between 50 and 74. These changes in recommendations will change the way physicians approach screening and may have long term affects on breast cancer survival rates—only time will tell. Dr Price has criticized the USPTF for not having enough expert specialists — particularly in the areas where they are making their more controversial recommendations.

Americans spend far more than any other country on medicine and treatment, yet we’re No. 42 in life expectancy and No. 56 in infant mortality. That’s because Americans generally don’t feel that health is an individual responsibility or that behavior modification is a way to prevent disease.

Fortunately, a large body of data supports the use of screening tests for chronic diseases, and we have reliable tests for prostate, lung, colon and breast cancers — just to name a few. But these tests are not without debate within the medical community. Some say widespread, population-based screening leads to more unnecessary tests and procedures, putting patients at undue risk. Others say doctors use screening tests to generate more patients and procedures.

Nothing could be further from the truth.

We must change the way doctors and health care systems think in the U.S. today. The Affordable Care Act — ObamaCare — was supposed to give patients access to more preventive care. But, in reality, all it did was provide emergency access to those who had urgent medical needs. Lack of accessibility, high costs and lack of timely availability of physicians who participated in the ACA exchanges limited patients from receiving preventive care.

We must reward physicians for preventing disease. We must hold patients individually accountable for behaviors that put them at higher risk for certain diseases. If we are to ever improve outcomes, increase life expectancy and improve infant mortality rates, it will be due to changing health and wellness behaviors, not from spending trillions of dollars on treating chronic preventable diseases.

Prevention also has long-term economic effects that reach far beyond direct medical costs. It can reduce absence from work — absenteeism resulted in nearly $85 billion in productivity losses last year alone — and improve worker and corporate productivity.

Good health affects us all. It affects our quality of life and the economy, as well. But prevention starts with you. It entails:

  1. Taking stock of your own health risks.

Understand your family history and how it affects your risk for disease. Know your numbers — BMI (body mass index), fasting blood sugar, blood pressure and cholesterol. If you know your individual risk, you can make changes to affect it.

  1. Making changes to modify risk.

Understand that exercise and diet are critical to reducing risk. Know that smoking is the No. 1 cause of preventable death in the U.S. today. Obtaining an ideal body weight or BMI reduces your risk for diabetes, high blood pressure and heart disease (the No. 1 killer in the U.S. today). We must address key indicators of health outcomes — smoking, physical activity levels and diet — to improve our health and reduce costs.

  1. Getting regular screenings

Work with your health care provider to make sure you know when and how to screen for cancers and other diseases. If you test positive, get multiple opinions before you do anything, so you can make the decision that’s right for you.

  1. Engaging with a health care provider/partner

 Developing a long-term relationship with a physician can make a big difference in your health status and outcomes.

Tom Price, as HHS secretary, will help us begin an important transition in American health care: focusing on the patient — not the politics — and making sure we prevent disease before too many lives are lost. Prevention must be our goal.

I challenge all my colleagues who treat terrible diseases … Let’s put ourselves out of business. Let’s work to make America healthier than ever

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Keeping Campaign Promises: Trump Issues First Executive Order to Repeal Obamacare AND a Call to Action for Congress

Throughout his campaign, Donald Trump was a vocal critic of the Affordable Care Act. Within hours of his swearing in, President Trump issued his first executive order aimed at dismantling Obamacare. In a meeting in the Oval office before he left for the Inaugural Ball, the President signed an order that aggressively begins the process of repealing the ACA. While the order itself cannot repeal the law, the document goes a long way toward eliminating key portions of Obama’s signature legislation.

Taking A Closer Look at the Executive Order—What’s In It?

In the one page order there are several important statements to note—powerful words that will effectively begin the dismantling of Obamacare even before Congress begins its debate in the coming weeks.

First of all, President Trump orders the immediate repeal of the Affordable Care Act and directs all agencies to “take all actions consistent with the law to minimize the unwarranted economic and regulatory burdens of the act and prepare to afford the States more flexibility and control”

In addition, the Order directs the heads of Federal agencies to “waive, defer, grant exemptions from or delay any provision…that would impose a fiscal burden on any Stat or a cost….on individuals, families insurers or makers of medical devices products or medications.”

Finally, President Trump orders all head of agencies to “encourage the development of a free and open market in interstate commerce for the offering of healthcare services and healthcare insurance”

What Will Be the Impact?

The most immediate result of Trump’s first executive order on healthcare is that he has now signaled both lawmakers and all Americans that he intends to make good on his promise to immediately begin work to repeal the ACA.

Using the words “to the maximum extent allowed by law” throughout the document also sends a message to all Federal agencies that they must move quickly and decisively to begin to dismantle certain provisions of the law. It is likely that a system will be developed to allow free competition of insurers for the individual market across state lines. IN addition, the move will likely result in less regulation and more flexibility for BOTH States and insurance companies—Something that had been requested and denied numerous times during the Obama administration.

While the order does not directly eliminate the individual mandate, it does substantially weaken the law by instructing government agencies to delay, or defer any tax penalties related to failure to purchase insurance. It is likely that no penalties will be levied going forward while Congress works to repeal the ACA.

While many insurers have pulled out of the ACA market due to high cost, high risk and low returns, President Trump’s orders may result in significant changes in the insurance market by providing more stability and predictability. By making the individual market more attractive to insurers through relaxing regulation and allowing for more inter state competition and business opportunities, it is likely that the Executive Order will result in more choices for consumers—whereas many Obamacare marketplaces currently have only one choice.

What Are the Next Steps?

The Executive Order sets the stage for the repeal of Obamacare. It is now incumbent on Congress and the likely head of HHS, Tom Price to move forward quickly. While repeal is vitally important, we MUST provide a simultaneous replacement. Uncertainty will undermine any efforts to revamp healthcare in the US and ensure coverage, access and affordability for all. A replacement plan must be produced and discussed openly in the coming weeks. I believe that Republicans in both the House and Senate have the scaffolding of a new healthcare law in place—now they must craft it into law. It is vital, however, that Republicans learn from the errors of their colleagues on the other side of the aisle—any legislation must be bipartisan—having one Party craft the law without ANY input from the other would be disastrous (just as the ACA turned out to be). A replacement healthcare law should address the shortcomings of the ACA and should keep the few things (such as protection for those with pre existing conditions) that actually worked.   We must continue to provide subsidies to those who cannot afford insurance in order to stabilize the market. We must, however, demand individual accountability from patients, doctors, insurers and government stakeholders. Patients MUST be engaged in their own care and take steps such as smoking cessation, diet and exercise, etc in order to improve their OWN health (in partnership with their doctors). Insurers must be allowed to compete across state lines and must be allowed to operate in ways that provide maximal access for patients but must be held accountable to control costs. Doctors must provide efficient, high quality care—and be allowed to do so without government interference.

There are many challenges ahead of Congress and President Trump in the coming weeks—none bigger than healthcare. The Executive Order issued on Inauguration Day has signaled that this administration will be one of action. Now it is time for Congress to do their part and provide a real, working replacement for the ACA that can be immediately implemented. We must remember that any new healthcare law must put #PatientsFirst and allow Medicine to return to its roots—Doctors and patients working together to improve health outcomes and ensure a long and happy life.

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Cyber Hacking and the Heart: How Science Fiction Becomes Science Fact, And How Profits Influence Policy

This week, the Food and Drug Administration (FDA) confirmed that pacemakers and implantable defibrillators (ICDs) manufactured by St Jude Medical are vulnerable to cyber hacking. This completes months of cooperative investigation and evaluation by the company and the FDA. An announcement was made on January 9, 2017 that Abbott—who recently acquired SJM in a deal reported to be worth 25 billion dollars—has provided a software patch as a “fix”. To date, the FDA has confirmed that no patients have been harmed by the vulnerabilities.

What Exactly IS the Security Issue?

Most implantable cardiac devices such as pacemakers and defibrillators (regardless of manufacturer) are now able to connect to home monitoring systems wirelessly so that physicians can monitor the devices remotely. These remote monitoring systems are essential in the long-term management of device patients. This technology allows healthcare providers to respond quickly to any device alerts, malfunctions or changes in a patient’s clinical status. All of these networks contain embedded computer systems that are connected to the internet and this makes them vulnerable to malicious cyber attacks and these vulnerabilities have been discussed since before 2013. All major manufacturers have these home transmitters and each differs in the exact frequency with which the transmitter communicates with the device. Previous research has shown that medical devices are vulnerable to hackers who were able to assume control of the device in a laboratory setting. In the case of the St Jude Medical devices, the FDA released their findings on security vulnerabilities in a safety report dated January 9, 2017. In the report, the FDA states that the agency “has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient’s physician, to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.” According to the FDA, the issue at hand is that hackers could potentially access the Merlin@home transmitter and potentially reprogram the device or prematurely deplete the battery putting patients at significant risk. Based on the completed review, SJM (now Abbott) has released a software “patch” that was recently designed to address the vulnerabilites in the Merlin@home system. The patch will be automatically installed wirelessly over the internet in all home monitoring systems this week. The FDA will continue to monitor cyber security issues and advises both patients and physicians to continue to conduct home monitoring as per routine.

How and When Did This Come About? Follow the Money….

This story began in August 2016, when Muddy Waters Capital, a privately owned investment research firm, first suggested that these vulnerabilities existed and advised that they would be short selling the SJM stock. Muddy Waters, in turn, first learned about the cyber security issues concerning SJM devices from MedSec, an independent cyber security company. At the time, Med Sec claimed that their research suggested that St. Jude Medical was “by far the least secure” of the four largest implantable cardiac device makers in the United States. SJM responded by saying that the claims were “absolutely untrue” and that the Muddy Waters investigation was based entirely on “financial gain”.

In September public record indicated that SJM sued Muddy Waters—calling the short seller’s claims “irresponsible” in a press release—and ardently defended the safety and security of their devices.  The FDA acted immediately by beginning a joint investigation of the SJM device vulnerabilities in cooperation with the Department of Homeland Security. During the last year, SJM had been in the process of negotiating an acquisition deal with Abbott laboratories—the deal closed January 4, 2017.  Five days later, the FDA safety report was released.

Internet Connected Medical Devices Are At Risk: Guidance From The FDA

In December of 2016, (before the current SJM findings were released) the FDA published guidelines regarding cyber security issues and medical devices. As medicine becomes more digitally connected with patient devices being accessed via smartphones, tablets, doctor’s offices and hospital systems, security vulnerabilities are becoming more of a concern. In the document the FDA makes it clear that all medical devices are at risk and that more must be done in the pre market phase by industry to design more secure portals for data collection and device integration. I addition, more study is needed to identify potential risks and impact to patients. The guidance statement goes on to recommend a much more vigorous post market cyber security surveillance and suggests that all of the findings should be shared with the FDA. I expect that in the future, there will be a great deal more regulation involved for medical devices that are capable of wireless communication across the internet.

What Can We Learn from This? What’s Next?

Our lawmakers and the FDA must do more to regulate the medical device industry. We must do more to PUT PATIENTS FIRST. I am certain that SJM is not the only company with devices that are vulnerable to hacking—we have had reports of other devices—from MRI scanners, IV infusion pumps, personal insulin pumps and other connected devices that either have been compromised or have been identified as high risk. I think it is important for device makers to be proactive and tell us what we need to know now—What are they doing to do NOW to protect patients from cyber attacks? Outside research firms have suggested that most cyber security efforts related to medical devices and healthcare systems are lagging nearly a decade behind current technology. Many devices are still working on operating systems with known vulnerabilities such as Windows 7 and Windows XP.

I agree with the spirit of the FDA guidance statement from last month but I expect MORE. We must pursue post market cyber security issues aggressively. We must make every effort to identify and mitigate risk quickly. I would advocate for more cooperation between companies in cyber security efforts—by combining efforts to create more secure environments for medical devices and information, all parties will profit and ultimately patients and the healthcare system in general will benefit. . As a physician and a patient advocate, I am ready for change. While we must continue to promote free market competition and innovation, we MUST also protect the very people we are intending to serve—the patients who depend on us—and our devices—every single day.

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