93 posts categorized "Health Policy"

12/13/2016

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

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Facing Addiction Cover Twitter 506x253
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

03/01/2016

Can technology stop drug prices from rising?

There has been a well-documented trend toward higher drug prices in the US. Turing Pharma turned heads by raising the price of Daraprim® by 5,000 percent, and there has been more news coverage of the practice of hiking drug prices. At the same time, new technologies and group purchasing power are being harnessed to counteract this trend. These two competing forces will help shape the ongoing debate on drug pricing.

In early February 2016, Blink Health announced the launch of its mobile app and website, purposed to help consumers secure the lowest possible retail price. Blink is not a retail pharmacy, but it works with MedImpact, a pharmacy benefits management company affiliated with 60,000 pharmacy locations. Users can supposedly get better prices on generics, because Blink can use its group purchasing power to negotiate lower prices. The app and website quote a price, which the user pays prior to going to the pharmacy. He/she still must provide a prescription to the retail pharmacy, but the price is secured for any of the affiliated locations.

Blink claims that users can save 80% on generics; that 40% of its medications cost less than $5; and, that 50% of its medications cost less than $10. The company claims that higher prices cause patients to skip doses and to stop the regimen entirely. They claim that their tool will help increase access to medications through lower prices.

Navigating drug pricing is notoriously labyrinthine. Most retailers do not post their prices and prices vary for different consumers and consumer types within the same market. Lisa Gill, deputy editor of Consumer Reports Best Buy Drugs is quoted by the NY Times saying, “The prices are all over the map, even within the same ZIP code.”

Since 2006, Wal-Mart, the world’s largest retailer, has been providing certain generics for $4 for a 30 day prescription. The company maintains a list of drugs that it provides at that price. The company provides this price by using its purchasing power, and by taking advantage of its distribution system. There are other programs, such as GoodRX, that aim to provide patients the lowest possible prices on generics. GoodRX is similar to Blink Health, but it provides coupons to be used at the retail site. Blink allows patients to pay for the drug prior to picking it up at one of the affiliated pharmacies.

Brand name drugs fall outside of the scope of these programs. In addition, generic drugs like Daraprim®, which is a sole-source product, will not likely be affected by these and similar price control programs. However, Wal-Mart, Blink, GoodRX and others are applying downward price pressure to the market for generic drugs. Whether this is sufficient to keep prices under control, overall, is yet to be seen. The companies leverage technology to secure lower prices. Consumers demand lower prices, and these services will survive and profit if they provide value to consumers. The prices they offer are closer to the prices paid by insurers.

High drug prices can have a deleterious effect on patient behavior. As Blink Health has claimed, higher prices often discourage patients from filling out prescriptions and often push them to skip doses. Tools that help patients secure drugs at lower prices, even if only in retail settings, should have a positive effect. A case can be made that these tools address only the symptom of higher prices and not the causes. Factors that drive up prices may be ignored, since these tools provide lower prices as an end result. Drug companies can refuse to address higher prices by pointing to these tools as proof that their drugs are ultimately affordable.

The ongoing drug price debate, fueled by Turing’s move and others, highlights the high cost of prescription medications. The new tools take advantage of the information gap between consumer and producers. They do provide a valuable service, although the debate continues. Should there be price controls on critical drugs? Should the US move to a single buyer system, as is the case in Canada and European countries? If so, Blink, GoodRX, and other similar businesses will be impacted, since they would be unable to provide lower prices than that set by the government.

Magdi Stino, Health Policy PhD Candidate

02/15/2016

Turing Pharma and the drug price debate

In September 2015, Turing Pharmaceuticals raised the price of Daraprim® (pyrimethamine) from $13.50 per tablet to $750.    The 5,000 % price increase put the national spotlight on the practice of rising drug prices, including for generics such as Daraprim, which is used to treat toxoplasmosis infections.  The company’s CEO, Martin Shkreli, has been vilified in the press and in social media, which has kept the subject in the public consciousness.  The price hike by Turing, which had only acquired the drug that August, was seen by many as price gouging.  Shkreli’s action has heightened scrutiny of drug pricing policies, and raised public awareness of the arbitrariness of pricing in the US market.

Shkreli defended the move, contending that the higher profitability means more funding will be available for toxoplasmosis research.  If the market size is limited, then profitability would come through higher margins.  The higher margins, Shkreli’s camp argues, compel manufacturers to produce enough of the drug to meet demand.  No one who needed the drug has been unable to get it due to price, the company has claimed, and Turing provides support for those who are unable to afford it.

Turing also argues that it has been singled out for media attention for the practice of acquiring a drug and raising its price.  Older drugs, such as Cycloserine®, a tuberculosis drug, and Doxycycline®, an antibiotic, have had their prices raised after acquisition.  Valeant purchased Isuprel® and Nitropress® and subsequently raised the price for both.  CBS News reported that a Bloomberg News study found that 20 prescription medications have had their prices quadrupled since 2014, and 60 drugs have had their drug prices at least doubled.  The same study found that Novum Pharma raised the price of two anti-inflammatory steroids, Alcortin A® and Novacort®, by 2,000 and 3,000 percent respectively during that period.  In this light, Turing’s move was not completely out of the norm.

Critics counter that such dramatic price increases are dangerous.  The Infection Disease Society of America (IDSA) and the HIV Medicine Association (HMA) sent a letter to Turing warning that the practice was “unsustainable for the health care system”  and posed a risk to public health.  Social media has lambasted Shkreli for exploiting people with serious illnesses for the sake of profitability.  Shkreli, his critics contend, is behaving more like a hedge fund manager than as a steward of the public health.

Since this story broke, more attention has been given to the practice of hiking drug prices such as at Gilead.  The company is facing scrutiny for the cost of two hepatitis C medications, Sovaldi® and Harvoni®, which cost $84,000 and $94,500 respectively for each regimen.  The attorney general of Massachussetts wrote a letter to Gilead,  saying she was looking at whether drugs are overpriced, and whether to invoke consumer protection laws in that effort, which would be a first.   Pfizer has faced criticism for hiking the prices of 100 drugs in the beginning of January 2016 and its planned merger with Allergan has emerged as an issue for Democratic presidential candidates Hillary Clinton and Bernie Sanders.  Truveris, a research firm, found that drug prices had gone up by 10.4% since 2014, and that brand names have gone up by fifteen percent.

While Shkreli and Turing’s move was jarring, the public now knows that price increase are not extraordinary.  New specialty drugs entering the approved drug market are further driving up prices.  BY contributing to higher healthcare costs, price increases for existing drugs reduce the apparent effectiveness of health care spending. Prescription drugs make up a substantial portion of US national healthcare costs, which are highest in the world.   The price increases lead to higher insurance payments and copays.

An investigation has been opened by the House Committee on Oversight and Government Reform.  Ranking member, Rep. Elijah Cummings, released memos from a preliminary investigation which appeared to show that the price moves by Turing were purely for increasing profits, and that R&D costs were minimal.  Shkreli testified before the House Oversight and Government Reform Committee on February 4, 2016, where he repeatedly invoked his Fifth Amendment right not to self-incriminate.

Shkreli was arrested in December 2015 for allegations of securities fraud prior to his takeover of Turing and has continued to draw public notoriety for his actions.  He has, through his public defiance, caused the discussion to persist.  It is notable that national vilification of Shkreli has contributed to the debate, demonstrating that personalities can impact policy as much as raw numbers.

Affordable medications are a crucial part of public health.  Likewise, the profit motive provides an incentive for pharmaceutical companies to produce sufficient quantities of a particular drug.  In the current system, a balance is needed.  Turing’s price hike of Daraprim has heightened the scrutiny of a perceived imbalance towards profitability and away from affordability.  With drug prices entering the presidential elections, it is likely that pricing will continue to be a major political issue.

Magdi Stino, PhD Candidate, Health Policy

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