95 posts categorized "Health Policy"

04/07/2017

Healthcare in Transition

The Trump administration began with the bold declaration to end the Affordable Care Act (ACA).  As time has passed, this has proven more difficult than the president originally planned.  The problem has become that the lack of clarity upon what will happen as health insurance is reworked.  This uncertainty has led to insurance companies losing their desire to stay in the ACA market places.  Already, the ACA has resulted in one insurance company, Humana, suffering from particularly difficult losses and quitting the market place.  With even more questions about the future of healthcare laws, it stands to reason that more health insurance agencies will follow.  For this reason, the Trump administration has decided to make interim rule changes to increase the solvency of the program until the new program has been created.  In short, these changes are three-fold:  first narrowing the enrollment window, second expanding the definition of silver-care plans and lastly giving more time for insurers to create plans for 2018.  My goal in this post will be to assess how it will affect insurers, the public and add a bit more context to the problems associated with repeal that have occurred.

Moral hazard is when one party partakes in behavior that can negatively impact another party.  For health insurers under the ACA, this is when individuals opt to join an insurance company only upon realization that they were sick.  This behavior should theoretically have trade-offs.  The fact that adverse selection for pre-existing conditions can no longer occur removes the major incentive against such actions.  Thus, it is wiser to not sign up for healthcare until it is necessary.  The problem that such waiting causes is that insurance is based on a sick-healthy ratio, and additions of sudden sickly individuals would decrease the profits that they had projected to earn.  By narrowing the time frame associated with late-term insurance enrollment, the ability of insurers to ensure profits intrinsically rises.  The fallout of this change, however, is that it may lower the amount of young people who can get insurance in the first place.  The people most likely to enroll at the last minute are the young.  These are individuals who are most needed for insurance companies to thrive.  In this way, the new regulations are a double-edged sword.  By eliminating the younger, more beneficial aspect of the ratio, Trump’s Health and Human Services department (HHS), has made it such that the potential to end up with a more sickly pool of people for insurance companies is higher.  If this were to occur, it would back-fire in its implementation yielding a more unstable market for insurance companies.

Under the ACA, the insurance market has various tiers for the health care plans.  They are summarized in descending order of value as platinum, gold, silver and bronze.  Under the current regulations, silver plans have an actuarial value (AV) of 70%.  By this it is meant that if an individual from a standard population needed healthcare, 70% of their healthcare expenses could reasonably be expected to be covered.  In implementation, a range variance exists allowing for +2 points of coverage meaning insurance companies actually pay between 68-72% of costs.  The change the Trump administration hopes to put into effect would allow a lower minimum value.  Under the new regulations, the variance range would become -4/+2.  By increasing the variance, a silver plan could now have an AV of 66% instead of the current 68%.  This would greatly increase the number of plans an insurance company could create.  However, it would also lower the value of the plans in question.  So while insurance companies would definitively benefit from this change, for the consumer, it is a mixed blessing.  By increasing the burden on individuals, a stronger argument could easily be made for a health reform bill to replace the ACA. However, it would also go counter to the desires of the constituents who voted for President Trump.  Interestingly enough, the change to AV values will have far broader implications than one might initially think.  This owes to the way that tax credit costs are currently calculated.  Since tax credit costs are based on Silver plan values, tax credits given by the government would be directly impacted by these changes.  The tax credit value, known as the “benchmark”, is based on the second lowest value silver plan in an individual’s area.  The amount of tax credit for an individual could be as low as 66% of the cost rather than present minimum of 68%.    Since the tax credit would be lower, it can then be safely assumed that some individuals may not be able to afford the more expensive plans. Thus, insurance companies may see a decrease in enrollment.

The new administrations is realizing that creating a new healthcare law is more difficult than originally believed.  This owes to the fact that the ACA may have many problems, but has done a large amount of good for the nation as a whole.  If nothing else, the number of uninsured Americans has dropped substantially thanks to the law.  The general anger from Trump supporters about the healthcare law seems focused on its limitations and the lack of value from the law.  This makes it far more problematic to create a new healthcare law when all current plans are similar to Rand Paul’s replacement bill, see here or Tom Price’s plan see here.  The part of the ACA most often cited as problematic is the individual mandate.  Some have criticized it as “un-American”.  This stems from the fact that it is the federal government forcing individuals to buy insurance.  The problem is that removing the mandate would only serve to destabilize the insurance market.  Insurance companies would constantly raise rates in an attempt to make-up for the losses.  Eventually, insurance might become virtually unfeasible for the American population.  At this point everyone loses health insurance.  At the same time, the world is not stopping for the Republican Party to make a better law.  So by expanding the time before insurance companies must give a decision about staying in the market place, the Trump administration hopes that it will be able to alleviate the short term problems while a much better long-term alternative takes shape.

Ultimately, the ACA is a bill that has proven a transformative bill for American healthcare.  While certain specifics, like the individual mandate, are not well received, the bill has had success in getting more people health insurance.  There is a good case to be made that the Trump administration’s changes to the health law could help stabilize the market.  The problem is that the basis for that argument is also the basis of the reverse effect happening, making the situation worse.  Allowing for worse overall healthcare for some as a trade-off to stabilize the market can easily be made thanks to the steadily more plausible idea of a death spiral.  At the same time, putting the burden on the most susceptible Americans will strike a nerve with many who fight for the voices of the poor.

My opinion is that, reluctantly, the changes could yield a net good for the nation.  By this I do not mean that all the changes are for the best, just that there is enough well thought out logic to see why the Trump administration is making these particular changes.  However, the ultimate problem is that so long as questions about a new healthcare system remain in the balance, these temporary patches will only serve as the equivalence of tying a tourniquet to a man bleeding to death; a temporary fix without much value if proper treatment is not issued as soon as possible.

Kunle Adejare, PharmD '19

03/29/2017

21st Century Cures Act – Promises or Problematic?

Late last year a new healthcare act was passed.  The 21st Century Cures Act has been lauded by many on both sides as a compromise that would help many sick individuals. The 21st Century Cures Act promised to bolster new cures and create faster regulatory processes that would help the nation get promising innovative cures to those who need them.   The basis of these claims is that the nation’s current set-up slows down innovation by asking for randomized control trials (RCTs) and spending too little on finding new cures. While these claims seem true on the surface, many criticize the new healthcare act for its incentives for pharmaceutical companies.  Personally, I have a saying that goes “A good compromise will probably leave both sides unhappy.”  So when an act passes with as much praise and speed as the new act did, I cannot help but wonder if the disadvantages would outweigh the advantages.  For this reason,  I will analyze the act’s contents to determine strengths and weaknesses of the act, then make an informed conclusion as to whether it is a net positive or negative.

The positives of the 21st Century Cures Act are numerous.  The biggest benefit for society  would have to be funding for the National Institute of Health (NIH).  The NIH is an invaluable part  of research funding in the nation.   Since the NIH does a large portion of its research through grants, organizations can more efficiently allocate money given to them in ways that benefit their research.  That established,  the new act has secured over 4 billion dollars for the NIH over the next 10 years.  The NIH is probably the single greatest driver of innovation owing to the intrinsic costs of pathophysiologic research.  The fact is that pharmaceutical companies can make no guarantee that the research to discover the pathophysiology of a disease will yield them any wealth.  It is actually a well-known fact that as much as $3 billion can be invested in new drug discovery research and no new drug may be approved by the Federal Drug Administration (FDA).  This is because the complexities of biology prevent researchers from always knowing the effect of changes they make.  In essence, intended benefits and side-effects generally do not yield actual benefits and side-effects.  So, funding the NIH to do the burden of such research frees pharmaceutical companies to aim more money on specific treatments. This will make it cheaper to find cures for disease with few or no treatments and expand the treatments already in existence.

One of the major concessions of the act, from a safety stand point, is that the 21st Century Cures Act has eroded the FDA’s strength to determine the value of new cures.  The problem with the act comes in the degradation of the data that is being given to the FDA.  It is no secret that RCTs are regarded as incredibly valuable data.  This owes to the fact that personal experience is subject to many external factors including one’s own biology.  The bigger issue with the new law and the FDA is “real-world experience.”  From a scientific standpoint, RCTs are “ideal-world experience”.  RCT’s do not give perfect data of all the flaws of a drug, they set a relatively high bar that allows the FDA to make reasonable assumptions about the safety of a drug.  By moving over to “real world experiences”, more side-effects could be missed.  This is important because many drugs carry risks that are not discovered until years after they have been in the market.  Considering that it takes 12 years to get a black box warning on a medication and 5 to get it removed, the negative implications of rapid approval start to become more worrying.   Without expediting the process of getting black box warnings added or getting drugs removed from the market, it becomes worrying that many new drugs are being added to the market. 

The 21st Century Cures Act’s most worrying aspect is that it could lead to many dangerous drugs coming to market, without novel drugs that may help ever seeing the light of day.  The FDA was created at a time when dangerous substances with little or no medical value were being peddled as cures.  The act could end up creating more overall problems caused by an expansion of medications known as me-too drugs.  To be fair, me-too drugs do come with benefits.  In the statin class, many me-too drugs currently exist for the sole purpose of competing with other drugs in that class.  Because the market, dyslipidemia, is so large even a small percentage can be worth billions over a decade.  If one can make an improvement in this class then the benefits are net positive.  Me-too drugs can also increase economic output via creating a need for advertising, production and other media.  Another noteworthy advantage is that it could lead to drugs that are not as potent as a competitor getting priced more cheaply to undercut the competition.  The problem is that, it could also jeopardize patient safety by adding many new drugs with too little information on them.  The lack of information could lead to inappropriate use creating harm or death.  For example, 81 mg aspirin is no longer sold under the therapeutic label of “baby aspirin”.  This is because it was noted that 81 mg aspirin could cause Reye’s syndrome in children with viral infections.   Adults are not subject to this same deadly adverse effect, and with the existence of other drugs such as ibuprofen or acetaminophen, it was decided that aspirin would no longer be used in children.  Since even well-known drugs can have interactions that are not well known for years, adding more medications with less data could have effects that will not bode well in time for society.  While adding new classes of drugs can hold many of the same negatives, it also gives a unique form of treatment.  In the long run, new drug classes could potentially be used in conjunction with existing therapy.  In this way, the funding for new drugs comes off as dubious.

In summation, while the 21st Century Cures Act was a well-intentioned idea, its overall likelihood for net negative healthcare is high.  The positives are noteworthy.  We will see more drugs enter the market.  This will almost assuredly increase the number of jobs and boost the economy in general.  New cures will help patients and lead to instances of better outcomes.  At the same time a rational person can look at the situation and say that the possibility for negatives does exist.  Adding 1 or two more high intensity statins could help the healthcare industry, but if a patient is statin intolerant then 20 new cure does not help.  Also, those who are already doing well on a statin but might need an additional medication will not benefit from this new act.  Adding more problems is the lack of data that is compounding this problem.  In the healthcare industry, mistakes can be life altering or threatening.  Adding more potential cures without sufficient data to assess them is not a good idea.  In this respect, the 21st Century Cures Act is problematic legislation that will not help patient healthcare as much as it was promised to do.

Adekunle O. Adejare, PharmD Candidate – ‘19

12/13/2016

The U.S. Surgeon General "Facing Addiction" report challenges myths, offers transforming vision

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U.S. Surgeon General Vivek Murthy has released a landmark public health report with a vision for transforming our behavioral health system so that we can adequately treat substance use disorders in America. Coming in the midst of an unprecedented opioid overdose epidemic, the document spells out why federal officials have shifted their approach on drug control policy to a public health approach.

Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health was released on Nov. 17, 2016 with fanfare, during a live-streamed broadcast from the Paramount Studios in California, featuring health agency officials, celebrity speakers, recovery community members, and a question and answer session with researchers (recording available on youtube).

At over 400 pages, the report provides a comprehensive review of the medical literature, makes recommendations, and notes gaps in our knowledge that need to be addressed with more research. Kana Enomoto, Principle Deputy Administrator of the Substance Abuse Mental Health Services agency, was the report editor. Facing Addiction in America states that:

  • A public health approach to the issue of addiction requires that we integrate substance use disorder services into the “mainstream” health system, a major change after decades of a segregated system of care.
  • The common belief “that alcohol and drug problems are the product of faulty character or willful rejection of social norms” is wrong, and results in damaging stigma that inhibits people from getting help.
  • Addiction is a medical disorder, a disease of the brain, that can be successfully treated with a comprehensive approach, just like many other chronic medical conditions.
  • Prejudice and discrimination have created many of the challenges currently plaguing the substance use disorder treatment field, and nothing short of a culture change will have to happen to transform the system. 
  • 1 in 7 people will misuse alcohol and other drugs, and more than 20 million people in the U.S. have a substance use disorder, yet only 1 in 10 are getting treatment. 
  • 78 people die every day in the U.S. from an opioid overdose, and those numbers have nearly quadrupled since 1999. 
  • About 25 million people are in successful recovery. Research indicates that approximately 50 percent of adults who once met diagnostic criteria for a substance use disorder are now in stable remission (1 year or longer). Even so, remission from a substance use disorder can take several years and multiple episodes of treatment, along with recovery support services, and/or mutual aid (participation in 12 step-type groups).

Health policy experts, the media, and Dr Murthy himself are making comparisons between this report, and a previous milestone in public health, the 1964 Surgeon General’s Report on Smoking and Health, released by Surgeon General Dr. Luther Terry. That groundbreaking  effort was the first federal government report to connect smoking with lung cancer, heart disease, and other detrimental health effects, at a time when years of tobacco marketing had positioned smoking as a safe, socially attractive, and even healthful. It spearheaded 50 years of tobacco control efforts that have positively improved the public health.

Dr Murthy and the other healthcare leaders emphasized in the Nov.17th summit that better screening, and earlier intervention can save lives:

 “…many people seek or are referred to SU treatment only after a crisis, such as an overdose, or through involvement with the criminal justice system. With any other health condition like heart disease, detecting problems and offering treatment only after a crisis is not considered good medicine. Integrating screening into general medical settings will make it easier to identify those in need of treatment and engage them in the appropriate level of care before a crisis occurs.”

Like hypertension or diabetes, substance disorders can and should be addressed before they reach the crisis stage. The widely held stereotype that people need to “hit bottom” before they can begin effective treatment is wrong and dangerous.

The Facing Addiction report is broken into sections that can be downloaded individually, including an executive summary, fact sheets and key findings, plus many supplemental materials. A printed copy of the full report can be ordered for free.

More key points:

  • Adolescent misuse is a risk factor for developing a severe use disorder, underscoring the need for prevention efforts, as well as early treatment.
  • Changes in specific brain circuits impact decision making, self-control, and other aspects of brain function in ways that are persistent and long-lasting, after prolonged substance use.
  • The brain can also take a long time to return to health, one reason why relapses are expected in substance disorders. Research in alcohol and other drug use shows it will be 4-5 years before the risk of relapse drops below 15%.
  • The medical consequences of substance misuse include cardiovascular and cardiopulmonary diseases, liver and pancreatic diseases, stroke, and cancers of the larynx, liver, and colon.
  • Studies show that every dollar spent on substance use disorder treatment saves $4 in health care costs.
  • Most existing substance use disorder treatment programs lack the needed training, staffing and infrastructure to provide treatment for co-occurring physical and mental illnesses.

To accomplish this behavioral healthcare transformation, the report notes that the treatment, prevention, and research sectors need appropriate funding. The legislature did not take action last year to fully fund the Obama administration’s requested $1 billion, but the “21st Century Cures Act” that just passed this week and is waiting for President Obama's signature, includes substantial new commitments towards the original funding goal.

The future of addiction health policy

Has our leadership been slow to address the widely held myths about addiction in America, the disparities in access to behavioral health care, and the need for systemic change? This new report is based on more than two decades of research which is “far more than we knew about the effects of smoking when the first Surgeon General’s Report on Smoking and Health was released in 1964.

A decade ago, in 2005, an expert panel convened by the Institute of Medicine called our behavioral healthcare system a "quality chasm" and recommended many of the same policies found in Facing Addiction in America. Still the new Surgeon General's report is intended to be the most prominent, and public effort to date to combat stigma with science, and refute the misconceptions about addiction that are deeply embedded in our culture. 

Public policy efforts to update our approach to substance disorder treatment include the 2000 passage of the Drug Addiction Treatment Act (DATA), which changed the Controlled Substances Act to allow physicians to treat opioid use disorder treatment with medications like buprenorphine in medical offices, rather than only in segregated clinics. However, this hasn't increased access to opioid use disorder as much as needed to meet the current demand.  

The Facing Addiction in America recommendations align with federal efforts under the Office of National Drug Control's public health-focused 2010 strategy to increase access to medication treatments, behavioral therapies, and recovery supports for substance use disorders. The Affordable Care Act of 2010 and the Mental Health Education and Parity Act of 2008 were significant legislative efforts to reduce inequities in behavioral health care access, although they haven't yet been fully implemented.

Dr Murthy headlined this 2016 report release with the vivid statement that “how we respond to this crisis is a test for America.”  This report is one of several initiatives at the end of the Obama administration that close out a period of major change in healthcare policy, but lead into an uncertain future.

With an incoming administration that has pledged to repeal the Affordable Care Act, credited for expanding access to substance disorder treatment for 60 million Americans, the future of these new policy recommendations and whether we can address the public health epidemic we are in today will be a test for our new leadership.

Notes on Language

Like many medical conditions, how we describe addictive disorders has changed over time. The last version of the behavioral health diagnostic manual (DSM V) changed the previous categories of substance “dependence” and “abuse” to a diagnosis of substance “use disorders” that exist on a continuum from mild to severe.  Substances refers both to alcohol and other drugs. Addiction medicine no longer uses the terms “chemical dependency" or alcohol or drug "dependence". 

Substance misuse is the use of any substance in a manner, situation, amount, or frequency that can cause harm to users or to those around them.

A substance use disorder is when prolonged, repeated misuse of a substance leads to a medical illness that impairs health and function.

Addiction is the commonly used term for a severe and chronic substance use disorder.

 

 

 

11/08/2016

Big jump in PA maternal and neonatal hospital stays, need for treatment, due to opioid crisis

baby withdrawal treatment opioids neonatal abstinence syndrome drug withdrawalAddiction treatment programs in Pennsylvania generally give pregnant women first priority in access to treatment. But with the opioid crisis straining already limited budgets and program resources across the Commonwealth, more access to treatment, housing, care management, and specialized programming for mothers is needed to meet demand, according to presenters at a Maternal Care Coalition forum.

Presenters at the Philadelphia program, held in September, described the impact of the opioid crisis on maternal health to a packed room of several hundred healthcare, social services, and public health providers. Local experts presented on barriers to care, funding challenges, and best practices in medication treatment and mentoring services for pregnant and parenting women, including a moving presentation from a mother in recovery, who gave birth to a baby in jail while imprisoned due to consequences of her drug addiction. 

Now we have new data to inform policy-makers about the increasing impact of the opioid epidemic on our healthcare system in Pennsylvania. The extra costs for hospital stays connected to maternal substance use are soaring.

The increase in pregnant mothers using opioids like heroin or prescription pain medications means more babies are being born with a physical dependence that requires treatment, according to a new report by an independent state agency that studies healthcare costs in Pennsylvania: the PA Health Care Cost Containment Council (PHC4). These babies often need to stay longer in the hospital to be treated for symptoms of withdrawal.

Rates of babies in hospital neonatal units (NICUs) needing withdrawal treatment have increased four-fold from 2003 to 2013 nationwide, according to a 2015 study. The research released by PHC4 shows similar increases in newborns needing more intensive treatment in the Commonwealth.

Neonatal hospital stays connected to substance use disorders (SUD’s) increased by 250% from 2000 to 2015 in Pennsylvania. This increase in hospital days fpr babies needing extra care cost an extra $20.3 million, most paid by state and federal taxpayers, since the majority of the mothers were on Medicaid (78% of the maternal stays that were related to SUDs and 38% of other maternal stays.) Our rural western and northeastern counties had the highest rates of SUD-related maternal stays. 

Maternal hospital stays were up by 510%, and of those connected to SUDs in 2015, 51.9% involved opioids, costing an additional $1.8 million. Some positive news: maternal stays related to alcohol decreased 36% and those related to cocaine decreased 61% in the 2015 data.

We do not know what percentage of the mothers in this data might have been in medication-assisted treatment (MAT) with buprenorphine or methadone. In other words, their use of opioids was prescribed appropriately and medically monitored. The research brief doesn't break down maternal opioid use to show if it was illicit or prescribed. But in the context of the current opioid epidemic, we know that illicit use has increased at unprecedented rates and is a key driver of increased hospital costs, along with the growth in prescribing of opioids for pain management.

Treatment with prescribed methadone or buprenorphine, along with counseling and behavioral support, is clinically indicated for a mother who wants to stop illicit opioid use while pregnant, because going into withdrawal if she stopped abruptly could cause her to miscarry. Unfortunately, some of the babies of mothers on prescribed MAT may have withdrawal symptoms that need to be treated and will require a longer stay in the NICU, but the health risks to the mother and baby in a relapse to heroin use, or during a sudden withdrawal from opioid use, are significant and possibly life-threatening.

A note about appropriate language for neonatal drug withdrawal  

Almost all the media reports about this data that I saw (but not the PHC4 research brief) referred to addicted babiesin their coverage. While the journalists and headline writers may be adopting a commonly used term-- it's just wrong to describe babies with withdrawal symptoms as “addicted.”Babies with neonatal abstinence syndrome, or drug withdrawal, do not have the compulsive behavior that is a defining aspect of addictive disorders; rather, they are physically dependent and require medically-managed withdrawal. Clinically inaccurate, emotionally laden language in stories about substance use disorders increases the stigma that people with substance use disorders face -- stigma that often deters them from seeking help. 

 

10/25/2016

More Faculty, Staff, Student and Alumni Achievements

Karin Richards, chair of the department of kinesiology, presented at the Regional Conference on Aging on the topic Calm Minds, Active Bodies.

She will also be presenting at on “Applying Behavior Change Techniques” at a workshop in Richmond Virginia.

Richards was also selected as a master trainer by the American Council on Exercise for applying behavior change techniques


 Paula Kramer PhD, OTR/L, FAOTA, director of the post-professional doctor of occupational therapy program, has been invited to give the keynote address for the New York State Occupational Therapy Association conference on November 5.


 Dorela Priftanji PharmD’17 was awarded the Pennsylvania Society of Health System Pharmacists Student of the Year Award at the annual assembly.


 Several faculty members and former colleagues were published in the American Journal of Pharmaceutical Education, Vol. 80, Issue 7. “Variables Affecting Pharmacy Students’ Patient Care Interventions during Advanced Pharmacy Practice Experiences” was a collaborative effort of Laura Bio PharmD, Brandon Patterson PharmD, PhD, Shanta Sen PharmD, Angela Bingham PharmD, Jane Bowen PharmD, Ben Ereshefsky PharmD, and Laura Siemianowski PharmD.


Jim Holaska PhD, associate professor of pharmaceutical sciences, recently published two articles listed below. One of the articles was a comprehensive review of diseases associated with mutations in nuclear envelope proteins and the proposed disease mechanisms. The second review focused on the cellular function of one of these proteins named emerin and how mutations in this protein cause muscle disease.

  1. Holaska, J. M. 2016. Diseases of the Nucleoskeleton. Comprehensive Physiology. 6:1655–1674.
  2. Collins, C. M., Nee, K. A. and Holaska, J. M. 2016. The Nuclear Envelope Protein Emerin and Its Interacting Proteins. eLS. 1–9.

Jessica Adams PharmD, assistant professor of clinical pharmacy, attended the 6th Clinical Pharmacy Summit in Manila, Philippines Sept 16-18th as faculty for ACCP. She presented on HIV, tuberculosis, sexually transmitted infections, opportunistic and fungal infections, and intra-abdominal infections to a group of pharmacists from the Philippine Pharmacists Association who are preparing to take the BCPS exam.


Amy Jessop PhD, MPH, associate professor of health policy and public health, and a recent grad, Muhamed Gashat MPH ’16 penned a paper entitled "Barriers to HCV Treatment in Methadone Users" was highlighted on the National Aids Treatment Advocacy Project (NATAP.ORG).


 Evana Patel PhB'16 won best paper in her session at the Academy of Business Research Fall 2016 Conference in Atlantic City

05/10/2016

What is Big Data and how will it revolutionize the health industry? Part III

Big Data has already made an impact in many industries, and is transforming how we think of healthcare and public health. It will continue to revolutionize healthcare, pharmaceuticals, clinical trial management, administration, and all aspects of the health industry. The US has the highest healthcare costs in the world, and our outcomes are often mediocre. The application of Big Data techniques will help reduce these costs and improve outcomes. As the field matures, we will see a cumulative effect, as insights build atop each other.

Big Data is a revolution, but it is still in its infancy. The truth is, we still have not come close to getting maximum value from our traditional methods of data analysis. Big Data makes use of the unbelievable volume, variety, and velocity of data being produced every second, and applies creative querying to make predictions and to make recommendations. It uses an open source architecture called Hadoop, which runs on commodity hardware, meaning that Big Data will be available to all organizations in the future. The challenge will be in asking the data the right questions, and querying the data sources in an appropriate way. These skills will be in very high demand in the near future.

However, there are some major challenges in applying Big Data in healthcare, particularly when it comes to protecting patient privacy. First of all, Health Insurance Portability and Accountability Act (HIPAA) compliance is mandatory, and violating HIPAA is a serious breach of the law and medical ethics. So, how do we integrate patient data while preserving privacy? Yes, data can be de-identified, but sophisticated analysts could determine the identity of individual patients.  In a White House reported on balancing Big Data and privacy, it was noted that policy alone cannot prevent data breaches, and that technology needs to be effectively implemented to prevent breaches.  It also makes the case that policy should focus on the harm caused by specific breaches. 

Breaches in privacy are a serious matter and companies deploying Big Data, just as before, must be vigilant in their use of technologies, such as encryption, to prevent breaches.  With so much data, the consequences of a data breach can be staggering.  It was revealed in 2015 that over 4 million current and former federal employees had their personal data stolen by hackers.  The data were held by the Office of Personnel Management (OPM). Therefore, companies with access to millions of patient records must be especially vigilant.

Breaches of massive datasets can result in more than just identifying information, such as social security numbers and addresses, as was the case in the OPM breach. As devastating as that was for the millions of victims, the potential damage from, for example, stealing patients’ genomic data could be even worse. We’re at the cusp of a new era in data management. The consequences of privacy breaches in this new domain have yet to be fully understood. Vigilance will be the key for all stakeholders.

The data that patients provide allow researchers to conduct extraordinary analyses and tease out information that was invisible under the old paradigm. Big Data analysis requires many people to share their data. So, policies should be in place that protect patients, while still encouraging them to share their personal information. Data encryption will play a role in preventing breaches. But, intelligent policies will be as important. Many times, hackers can bypass encryption and other tools due to a human vulnerability.

If companies do not enforce their policies effectively, then encryption can be neutralized as a deterrent. The STUXNET virus crippled computer systems in Iran’s Nantanz nuclear facility. The Iranians had physically isolated those information systems from other computer networks and the Internet. The virus exploited a vulnerability by introducing a virus onto the thumb drives of employees. Then, when one or more employees inserted the thumb drive into the computer system, STUXNET was able to spread and cripple the network. While this is an extreme case, and it is widely presumed that one or more intelligence agencies designed the virus, it does highlight how a breach in protocol can be exploited. It is not enough to have strong policies—companies must be able to enforce them as well.

Storing and accessing patient data without violating patients’ privacy is going to be a long-term challenge. Companies should have a clear written policy on patient privacy. In addition, they should take steps to ensure that data are not mishandled by mistake. The damage to patients can be serious, and the consequences to the company could possibly be catastrophic. Not only would they be vulnerable to lawsuits, HIPAA violations could actually lead to criminal charges.

Think Big!

Magdi Stino, Health Policy PhD Candidate

04/29/2016

What is Big Data and how will it revolutionize the health industry? Part II

Big Data is poised to revolutionize the healthcare industry. The revolution goes beyond just analyzing text based notes. It is being used in predictive analytics, prescriptive analytics, genomics, and in many other ways.

You may have heard the term “Internet of Things.” This refers to the fact that many devices are now connected to the Internet, from your phone to your car to wearables like the Apple Watch and FitBit. It is estimated that by 2020, there will be 25 billion connected devices.  These devices capture real time data, and allow for real-time alerts. They produce tons of data on the individual. In combination, they can provide us even more information on entire populations.

Big Data can fill in the blanks for predictive analytics, “the use of data, statistical algorithms and machine-learning techniques to identify the likelihood of future outcomes based on historical data.” Electronic Medical Records can be reviewed and analyzed. An individual patient generates much data which can be analyzed to make predictions on whether or not they will comply with their doctor’s recommendations. For example, one hospital found that patients who live in certain neighborhoods are likely to miss appointments. They concluded that it was actually cheaper to send them a taxi to bring them to the appointment than it was to deal with a missed appointment. This was determined by utilizing multiple data sources: patient data, neighborhood data, and administrative data.

Remember, these data are not all being collected by the researcher. They are being collected independently, and the researcher is able to query the different sources to make a prediction.

Prescriptive analytics are a goal of Big Data in healthcare–to be able to identify and predict the path of a patient, then intervene to set them on the right path. For example, if a patient is supposed to walk a certain number of minutes a day, their phone or wearable would be able to see, in real time, if they choose to do so. If the patient allows these data to be shared with their physician, the physician can connect with the patient and determine why they are not complying. This would allow for immediate interventions that were not possible before.

When a person uses their cell phone late at night, it may indicate they are having trouble sleeping, which their physician can then address. These are very simple examples, but they demonstrate how real-time data can be captured and used to nudge patients in the proper direction.

Genomics research is a third area of opportunity in Big Data. The cost of mapping out an individual’s genome has plummeted since the completion of the human genome project. The individual’s genome itself is a massive dataset. When you can compare the genomes of millions of people, you can gain insight into the effectiveness of medicines. We are already seeing a move towards personalized medicine, which will only be strengthened by the Big Data revolution.

Traditionally, an oncologist might find that patients of European descent respond differently from non-Europeans to a particular treatment, which can then be used to determine the first-line or second-line treatment for those subpopulations. Now, with genomic testing, oncologists can see that those with a particular genetic marker respond very well or not at all to a particular treatment. With rapid genomic testing, the oncologist can then use a patient’s genomic information to recommend the treatment most likely to be effective. We are now able to identify patient sub-populations based on genetic markers, which allows for targeted gene therapy, Think of the advances this will bring us in treating cancer or other devastating diseases.

As more genomic data are captured and compared, we will be able to make insights that were nearly impossible to make before. We can begin to see what was once invisible. The more data there are, the more insights we can glean.

When enough Big Data are available, the insights we will be able to make are beyond comprehension.   It is already transforming how we think of health and public health and it will continue to revolutionize healthcare for years to come.

 

Magdi Stino, Health Policy PhD Candidate

04/12/2016

What is Big Data and How Will it Revolutionize the Health Industry? - PART I

Big Data is one of those new terms that has been getting a lot of media coverage. If you’re like me, you have been confused by what it even means. The short answer is that Big Data is a new approach for organizing and analyzing the massive amounts of data being generated each day. Big Data allows for insights that were practically impossible under traditional approaches. We are at the doorstep of a revolution, yet we still haven’t maximized our potential with old techniques and approaches.

Before we dive into the future of Big Data, it helps to first realize how much data modern society is producing each day. Eric Schmidt of Google noted that “from the dawn of civilization until 2003, humankind generated five exabytes of data. Now we produce five exabytes every two days…and the pace is accelerating.” (How much is an exabyte?).  More recently, it was estimated that we produce two and a half quintillion terabytes of data every day as of 2012. These include everything from your credit card purchases, to the photos you take on your phone, to your social media posts. Everything is being digitized and ubiquitously captured and more data are being produced constantly. Every phone call you make is recorded. Every song you play in iTunes is documented somewhere.

We have an astounding volume, variety, and velocity of data–“the three Vs.” This is where Big Data comes in. Big Data is a new approach to storing, reading, and analyzing these data, which are distributed over many different platforms, and are not standardized. This differs from the traditional mode of data analysis.  The traditional approach has been to organize and build what are called “relational databases,” then apply statistical analysis methods to answer specific questions–often the databases are built for the purpose of answering those specific questions.

A relational database is simply a set of data tables, each made up of rows and columns, which are joined together by one or more columns used as an identifier. For example, if you have a student ID card, then the university has a table of all student IDs, with personal information about each student. Then, there would be another table, say one with course registrations by student. Every time you register for a course, a new row is created with your student ID and the course number. Because each table makes use of your student ID as an identifier, an analyst can find your information from each table–to create a class roster, say, or to print out your schedule for this semester. We can find all the student ID numbers registered for a particular course, then find information on each student from the other table.

A shopper rewards program works the same way. One table records your reward number and all your personal information. Companies can use what are called data mining techniques on this database to encourage more sales. For example, retailers already send catalogs and specials to their customers. If they know your shopping history, they can customize the mailers they send you to highlight items you are more likely to buy. Even just knowing the gender of the customer allows them to segment their advertisements, and get a better return on investment. The more they know about your preferences, and the preferences of people like you, the better they can customize their engagement with you.

But, even with sophisticated techniques like data mining, and with massive transaction databases, we are still not in the world of Big Data. The examples I just gave are part of the traditional approach. The tables are organized in advance, data are captured and recorded neatly in the tables, and normal methods of analysis are used. This is not Big Data–this is just lots of data.

Big Data, unlike this traditional approach, does not need to use relational databases in its analyses. The data are not “collected” in the same way. Oftentimes, the data are being collected (or archived) without the intent of analyzing them later.  Big Data does not have any structure. Data do not have to be neatly organized in tables with rows and columns like relational databases.

Nearly everything we do in modern society leaves a digital footprint. Big Data allows us to use and analyze these data by applying specific techniques.  Primarily, Big Data makes use of Hadoop for faster file storage and data retrieval. Hadoop, an open source architecture developed by Yahoo, based on research conducted by Google, is the primary Big Data tool. Hadoop uses a distributed filing system where raw data are saved across multiple nodes, using a single hierarchy of directories, usually saved in 64 MB chunks. The data are not cleaned or organized in any way, and no business rules are applied. The data are not transformed. Big Data, using Hadoop, allows users to query those data and gain meaningful insights. Facebook, as an example, uses Hadoop to store the massive data generated by its users every single second.

Practitioners of Big Data believe in the “sushi principle”; that is, data should be raw, fresh, and ready to consume. Don’t cook the data! Keep it in its raw form. 

Because Hadoop is open source, and runs on commodity hardware rather than specialized hardware, it is much cheaper and simpler to store data than traditional methods. However, the difficulty arises in later querying and analyzing the data.

Whereas before, specialists were required to build the data sets, create the schema, and capture the data in a consistent way, Big Data eliminates these required skills at the front end, since Hadoop standardizes the approach to storage

Big Data requires expertise and creativity in the querying end. Querying can be complicated, since the data are being retrieved from multiple sources, which are not organized in a standardized way. SQL is becoming the standard querying language in Big Data, as it has been in traditional relational databases.

Because it is so new, it has been said that the only people with 10 years experience in Hadoop, are the men who developed it in the first place.

This provides a huge opportunity for data scientists in the future, and Big Data will surely create a huge demand for analysts who can work within the architecture.

Magdi Stino

Health Policy PhD Candidate

04/07/2016

Lowering Drug Costs and the 340b Drug Pricing Program

In order to protect patients from high drug costs, the Centers for Medicare and Medicaid Services (CMS) offers several plans qualifying patients can sign up for (more information available here). There are patients however, who are in need of federal assistance on drug costs but do not qualify for one of these plans. In order to reach some of these patients, the congress created a policy under section 340B of the Public Health Services Act. This policy is managed by the Health Resources and Services Administration (HRSA) and is known today simply as the 340b drug pricing program.

This program is aimed at the hospitals and medical centers who likely treat these underserved patients populations. These organizations are known as , covered entities.   Examples of covered entities include, but are not limited to Federally Qualified Health Centers, Ryan White HIV/AIDS program grantees, children’s hospitals and sexually transmitted disease clinics (full list found here). Patients at these facilities who qualify benefit from access to 340b covered drugs because their drug costs will be significantly less than patients not eligible for 340b drugs. These facilities will benefit because the manufacturer and wholesaler are obligated to sell these drugs at the low 340b price. These savings are typically 23.1% for brand products and 13% for generic products. Covered entities also have the ability to negotiate lower prices from those discounts which would result in further savings. These entities are then reimbursed by Medicaid at slightly higher prices which fall somewhere above the actual acquisition cost or AAC. AAC is what the pharmacy pays for drugs. It therefore factors in all sales and discounts the pharmacy may receive from a wholesaler. Medicaid may pay pharmacies at slightly higher than AAC in order to incentivize pharmacies to participate in the 340b drug pricing program.

The 340b pricing program is still a work in progress. One of the principle issues has been compliance with the program. It can be difficult for covered entities to follow the rules HRSA has established for the 340b program. Imagine that there is a pharmacy with 10 stock bottles of a maintenance drug. One of those bottle was purchased for a 340b patient at a 340b price. The challenge is ensuring that only the 340b patient receives medication from the 340b stock bottle. This becomes incredibly difficult when you factor in many 340b patients on multiple medications. If patients who are covered by Medicare or Medicaid received 340b drugs at typical prices (AWP minus a negotiated percentage) then federal resources would be spread too thin to help the underprivileged.

Fortunately, more changes are expected to occur. One change is in regard to better defining qualifying patients. With new changes, patients must have in-person medical visits with a 340b covered entity to qualify. Another example of a potential change is with manufacturers. Before any changes, the HRSA did not have the power to audit manufacturers and ensure they were proving drugs to covered entities at a discounted price. With the changes, the HRSA would be given the power to both audit manufacturers as well as impose penalties on those who do not comply with 340b regulations. These changes, when implemented, will improve 340b but more is needed for 340b to achieve its original goal of spreading federal resources to the underprivileged.

Robert Bond, PharmD '18

Usciences Research Gains Traction in Men's Health

USciences’ motto is “proven everywhere.” One reason why the “proven everywhere” motto makes sense for USciences is because we teach students, and professors themselves use scientific research as the basis for teaching and scholarship. One such area is the Health Policy Program at Mayes College of Healthcare Business & Policy. Health policy is the investigation of problems in health (not just healthcare and its delivery) in its broadest sense using scientific methods of study to develop evidence-based recommendations for changes and innovations in policy. One challenge is that policymakers sometimes eschew data and evidence when making policy; rather, they are sometimes drawn to its opposite – anecdotes – heart wrenching stories from constituents.

When data and evidence alone fail to inform policy, another option that is available is to make the best possible case for particular policies using the force of ethical argumentation. In this regard, evidence and data receive bolstering through analysis of the very values that undergird health and provide exhortation for particular policy approaches. This is the case with some recent work undertaken by Health Policy Ph.D. candidate Janna Manjelievskaia, MPH and Visiting Assistant Professor, David Perlman, Ph.D.

Janna was working with colleagues on a paper examining the policy issues associated with the current U.S. Preventive Services Task Force (USPSTF) recommendations against testicular cancer screening. She suggested to her colleagues that perhaps the paper could be enhanced with an ethical angle. She asked Dr. Perlman, one of her professors who focuses on ethics in health policy and public health, to join in writing the paper, which was recently published in the American Journal of Men’s Health and presented at their conference. The lead author of the paper, Michael Rovito, Ph.D., an Assistant Professor at the University of Central Florida, was recently was interviewed by STAT about the importance of testicular self-examination. The paper, and the power of its ethical argument and coupled with careful, scientific examination of policy, are gaining traction with policymakers, which should hopefully result in a policy change by the USPSTF to change its current recommendation against testicular cancer screening. When that happens, it will be yet another instance of how USciences research and students are “proven everywhere.”

David Perlman, PhD

Janna Manjelievskaia, MPH

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