Pharmacogenetics Testing

DRUG-GENE TESTING

Drug-gene testing is also called pharmacogenomics, or pharmacogenetics. All terms characterize the study of how your genes affect your body’s response to medications. The word “pharmacogenomics” is combined from the words pharmacology (the study of the uses and effects of medications) and genomics (the study of genes and their functions).

Your body has thousands of genes that you inherited from your parents. Genes determine which characteristics you have, such as eye color and blood type. Some genes are responsible for how your body processes medications. Pharmacogenomic tests look for changes or variants in these genes that may determine whether a medication could be an effective treatment for you or whether you could have side effects to a specific medication.

WHAT PHARMACOGENOMICS TESTING DOES

The purpose of pharmacogenomic testing is to find out if a medication is right for you. A small blood or saliva sample can help determine:

  • Whether a medication may be an effective treatment for you
  • What the best dose of a medication is for you
  • Whether you could have serious side effects from a medication

The laboratory looks for changes or variants in one or more genes that can affect your response to certain medications.

Each person would need to have the same specific pharmacogenomic test only once because your genetic makeup does not change over time. However, you may need other pharmacogenomics tests if you take another medication. Each medication is associated with a different pharmacogenomics test. Keep track of all your test results and share them with your health care providers.

The need for pharmacogenomics testing is determined on an individual basis. If your pharmacogenomic test results suggest you may not have a good response to a medication, your family members may have a similar response. Mayo Clinic recommends you share this information with your family members. Your health care provider can also provide recommendations for family members who may benefit from having testing.

CURRENT LIMITATIONS OF PHARMACOGENOMICS TESTS

Current limitations of pharmacogenomics testing include:

  • One single pharmacogenomic test cannot be used to determine how you will respond to all medications. You may need more than one pharmacogenomic test if you are taking more than one medication.
  • Pharmacogenomic tests are not available for all medications. Because pharmacogenomic tests are available only for certain medications, your health care provider determines if you need to have a pharmacogenomic test prior to beginning a specific treatment.
  • There are currently no pharmacogenomic tests for aspirin and many over-the-counter pain relievers.

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New Opioid Guidelines

What’s included in the guideline?

The guideline addresses patient-centered clinical practices including conducting thorough assessments, considering all possible treatments, closely monitoring risks, and safely discontinuing opioids. The three main focus areas in the guideline include:

  1. Determining when to initiate or continue opioids for chronic pain
    • Selection of non-pharmacologic therapy, non-opioid pharmacologic therapy, opioid therapy
    • Establishment of treatment goals
    • Discussion of risks and benefits of therapy with patients
  1. Opioid selection, dosage, duration, follow-up and discontinuation
    • Selection of immediate-release or extended-release and long-acting opioids
    • Dosage considerations
    • Duration of treatment
    • Considerations for follow-up and discontinuation of opioid therapy
  1. Assessing risk and addressing harms of opioid use
    • Evaluation of risk factors for opioid-related harms and ways to mitigate/reduce patient risk
    • Review of prescription drug monitoring program (PDMP) data
    • Use of urine drug testing
    • Considerations for co-prescribing benzodiazepines
    • Arrangement of treatment for opioid use disorder

What’s new in the CDC Guideline?

 Dosage Recommendations

The dosage recommendations for exercising caution are lower than older opioid prescribing guidelines. Higher doses of opioids are associated with higher risk of overdose and death—even relatively low doses (20-50 morphine milligram equivalents (MME) per day) increase risk.

Assessing Risks and Harms

Previous guidelines focused safety precautions on “high risk patients,” however, opioids pose risk to all patients, and currently available tools cannot rule out risk for abuse or other serious harm. The CDC guideline provides recommendations on providing safer care for all patients. The guideline also encourages use of recent technological advances, such as state prescription drug monitoring programs.

Monitoring and Discontinuing

The guideline provides more specific recommendations compared to previous guidelines on monitoring and discontinuing opioids when risks and harms outweigh benefits.

What is the purpose of the new guideline?

The guideline helps providers make informed decisions about pain treatment for patients 18 and older in primary care settings. The recommendations focus on the use of opioids in treating chronic pain—pain lasting longer than three months or past the time of normal tissue healing. The guideline is not intended for patients who are in active cancer treatment, palliative care, or end-of-life care.

Opioids pose a risk to all patients. The guideline encourages providers to implement best practices for responsible prescribing.

Use nonopioid therapies

Use nonpharmacologic therapies (such as exercise and cognitive behavioral therapy) and nonopioid pharmacologic therapies (such as anti-inflammatories) for chronic pain. Don’t use opioids routinely for chronic pain. When opioids are used, combine them with nonpharmacologic or nonopioid pharmacologic therapy, as appropriate, to provide greater benefits.

Start low and go slow

When opioids are used, prescribe the lowest possible effective dosage and start with immediate-release opioids instead of extended-release/long-acting opioids. Only provide the quantity needed for the expected duration of pain.

Follow-up

Regularly monitor patients to make sure opioids are improving pain and function without causing harm. If benefits do not outweigh harms, optimize other therapies and work with patients to taper or discontinue opioids, if needed.

Guideline Infographic: Why Guidelines for Primary Care Providers?

Click here to read more on the new CDC guideline for prescribing opioids.

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MACRA… Are You Ready?

MACRA is Medicare Access and CHIP Reauthorization Act of 2015. It Repeals the Sustainable Growth Rate (SGR) Formula. Changes the way Medicare rewards clinicians for value over volume. Streamlines multiple quality programs under the Merit-Based Incentive Payments System. Also, it provides “bonus payments” for participation in eligible Alternative Payments Models (APMs)

The timeline for the MACRA implementation is as follows:

  • 2016 through 2019: MACRA establishes a 0.5% physician fee schedule each year.
  • January 2019: Based on qualification and eligibility.
  • Physicians may enter the APM track or the MIPS track.
  • 2020 through 2025: Medicare physicians fee schedule updates remain at 2019 levels with no updates

MACRA includes a Merit-based Incentive Payment System (MIPS). MIPS consolidates three existing quality reporting programs: the Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier (VBPM), and meaningful use (MU). The system also adds a new program, called clinical practice improvement (CPIA). These four programs establish a composite performance score (0-100) used to determine physicians payment. The categories are:

  • Quality- based on PQRS
  • Resource Use – based VBM
  • Meaningful Use of certified EHR technology based on MU
  • Clinical Practice Improvement Activities – new programs

MACRA also includes an Alternative Payment Model (APM) which defines any of the following as a qualifying APM:

  • An innovative payment model expanded under the Center for Medicare & Medicaid Innovation (CMMI), with the exception of the Health Care Innovation Awards recipients.
  • A Medicare Shared Savings Program (MSSP) Accountable Care Organization • Medicare Health Care Quality Demonstration Program
  • Another demonstration program required by federal law In order for a provider to receive enhanced payment through qualified APM, the APM must also meet the following eligibility requirements
  • Use of quality measures comparable to measures under MIPS
  • Use of certified electronic health record (EHR) technology
  • Assumes more than a “normal financial risk” (which is undefined), or is medical home expanded under the CMMI

A Physician receiving the designated percentage of Medicare payments or patients through a qualified, eligible APM based on the above requirements is considered a “qualifying participant” (QP)

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The Time is Now to Prepare for MACRA implementation

While the first year for MACRA is 2019, the AAFP anticipates the performance in 2017 may determine the threshold for the first year of MIPS in 2019.

If you haven’t reported data on quality measures through the Physician Quality Reporting System (PQRS) or as part of meaningful use, start as soon as possible. Penalties for not reporting or for low quality may impact you this year. Click here for more information.

If your practice doesn’t currently provide chronic care management (CCM) services, consider the cost-benefit opportunity for increasing revenue to support needed practice transformation or quality improvement projects.

An Ounce of Prevention Is Worth A Pound of Cure

Preventive care is more than just “an apple a day keeps the doctor away.” It is the first step we can take to manage a chronic illness and prevent a catastrophic event. Everyone has heard of the person that was in perfect condition, ate healthy, managed their stress, and they still succumbed to an early age fatality that happened to “come out of no where.” While this does happen for no apparent reason a small percentage of the time, more frequently it is due to an underlying cause that would’ve been caught during an annual check up.

Preventive care visits usually include immunizations, vaccines, physical evaluations, lab work, x-rays and medically appropriate health screenings. The physician will determine what tests or screenings are appropriate based on many factors such as age, gender, overall health status, personal health history and current symptoms or chronic health concerns.

Annual visits sound like they would be expensive for the facility, but it does not only get patients to return every year, but with the right tests you could save money. From a study by William Hogg, Neill Baskerville, and Jacques Lemelin, “Cost savings associated with improving appropriate and reducing inappropriate preventive care: cost-consequences analysis,”† they found that when you conduct the following appropriate tests based on a patients gender and age it can save your facility quite a bit every year. Hogg, Baskerville, and Lemelin said, “We wanted to estimate the proportion of a facilitation intervention cost that is offset and the potential for savings by reducing inappropriate screening tests and increasing appropriate screening tests in 22 intervention primary care practices affecting a population of 90,283 patients.”

The appropriate tests include the following:

  • Folic Acid
  • Smoking Cessation Counseling/NRT
  • Mammography 50 to 69 years of age
  • Hypertension Treatment
  • STD Screening
  • Flu Vaccination
  • Cervical Cytology

The conclusion of the study is as follows:

The total cost of the intervention over 12 months was $238,388 and the cost of increasing the delivery of appropriate care was $192,912 for a total cost of $431,300. The savings from reduction in inappropriate testing were $148,568 and from avoiding treatment costs as a result of appropriate testing were $455,464 for a total savings of $604,032. On a yearly basis the net cost saving to the government is $191,733 per year (2003 $Can) equating to $3,687 per physician or $63,911 per facilitator, an estimated return on intervention investment and delivery of appropriate preventive care of 40%.

The full study can be found here for further review and clarification.

Preventive care has the ability to save lives, and with the right tests done the ability to save money. Preventive care should be a number one priority when it comes to ourselves and our patients.

 

 

†Hogg, W., Baskerville, N., & Lemelin, J. (2005). Cost savings associated with improving appropriate and reducing inappropriate preventive care: Cost-consequences analysis. Retrieved from http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-5-20#Tab4

Meet Our Founder

Meet Our Founder

VC Medical is a medical services company that partners with the provider to be an extension of their office on outsourced services. Our focus is to improve process flow and overall revenue for providers while improving the quality of health care and increasing compliance with regards to the Affordable Care Act. We have three areas of expertise: Annual Wellness Visits, Laboratory Services and Revenue Recovery. Providers can capitalize on all of our services or just one to suit their needs.

Our Mission:

VC Medical Services’ mission is to develop and to organize the services, resources, goods, and personnel of hospitals, medical groups, doctor’s offices, local, state and federal government and make them universally accessible and successful for all parties involved. We are honored to be a member of the medical community and we thank all those who have paved the way for our success.

Q&A With Our Founder and CEO Sean Bledsoe

Q: Tell us a little about yourself.

A: I was in college athletics for the majority of my adult life.  It was so exhilarating and something that I truly loved.  My wife and I moved to KC to take a job and things changed and I was no longer in college athletics.  It was unknown territory for me.  But I look back on it and I needed that time to continue to build our family as my wife and I have 5 children ages, 3,5,15,16 and 22.  

Q: What was your reasoning behind starting VC Medical?

A: I was introduced to the “compound” pharmaceutical world by one of my coaching colleagues and started to work in that industry.  I must admit it was tough at the start.  We were struggling and only with one income, while I was in an industry I knew nothing about.  Fortunately, I had some relationships with some physicians and was able to start building a nice client list.  That industry was lucrative but the dependency on the pharmaceutical lab and sometimes inflated billing practice, I felt the industry wasn’t sustainable. Within 10 months the industry picked a fight on the billing side with insurance companies.  So I went to my wife and told her I felt I had an idea to help seal VC Medical into the industry but I just needed her to support and believe in me.  At that point we moved into the “laboratory services” space.  Where we became the sales force for private toxicology and DNA labs.  Which again was an area I needed to learn.  

Q: How did you start the process of your own start up?

A: I knew for us to be able to solidify and build solid relationships we needed to physically go check the labs we would be dealing with and see the staff side, the equipment and their billing practices.  Next, I got in an airplane and went to 7-8 different labs that we were working on a relationship with.  I learned a lot when labs couldn’t give me concrete billing information.  From there, we narrowed the search down and found 3 labs that we felt comfortable with.  At that point for me it was making sure we would have something that separated us from the rest of the private labs.  I really started to study what issues physicians were having it came down to these things 1) Communication with the outside lab, 2) Turnaround time, 3) Billing practice.  We learned VERY Quickly if we could have an impact with the lab on these three items we could bridge the relationship gap so in-turn our focus went to “High Level Customer Service”.  That philosophy has ignited the success we are seeing currently.  

Q: You’re a two year old company, have you reached profitability yet? If not, when do you think you will?

A: Yes we have had profit in year one and year two we have a goal of quadrupling year one’s profit and we have already started to expand our employees and feel we will eclipse 50 new employees before the end of 2016.

Q: How many clients do you currently have?

A: Currently we are servicing two large Accountable Care Organizations (ACO’s) and we are engaged with 3 large Healthcare systems and services 20 plus private physicians.  

Q: How many do you plan to have in the next 3 years?

A: We are on pace to add 16 more hospitals systems and feel comfortable with the addition of 7-10 more Accountable Care Organizations.  

Q: What are your 5 year mark goals for the company? Do you think you will reach and/or exceed them?

A: Our 5 year goals are to have been involved with serving 1 million Medicare Patients with our Healthy Plus Program designed for preventative care and for us to increase our employees to over 200 with 60% of those employed right here in the Kansas City area.  

Q: Why did you focus on annual wellness, lab services, and revenue recovery?

A: We choose to focus on Preventative Care with our Healthy Plus program largely due to the “mandate” by the Affordable Care Act. Like it love it or hate it the program is here and one of the major components is “population management” and increases preventative care. That’s the entire mission of the Healthy Plus program.  It’s designed to increase physician compliance, immediate on the spot physician reports, patient reports as well as the required 5 year plan all available in real time. Thus allowing the physician to treat, recognize and develop a care plan for his/her patients.  

Lab Services was for us to be able to assist in what we call the “blind spot” for lab request.  When a provider sends out a request to an outside lab there is a level of communication that has to be maintained and in our current healthcare climate physicians and their staff are super busy so we serve as the additional layer to communicate in real time and support the physician.  All while continuing to monitor the lab and keep them billing at “market value”.  Many patients are on monthly budget and don’t understand EOB’s our concern has been how can we advocate “indirectly” for the patient.  Well by VC Medical Group monitoring the outsourced lab and working with them to stay grounded with billing we make the flow of the outsources lab request more seamless.  

The Claims recovery was a NO BRAINER. We use the ERISA ACT provided by Congress to allow providers to go back and re-submit claims all the way back to 2010.  This allows the provider to recoup lost revenue as well as look for billing errors that their current billing company may be making.  The unique part is we do this with a contingency basis.  We don’t get anything unless we find recovery.  Of all the claims we re-submit back to 2010 we are finding 12-15% errors and recovering hundreds of thousands of dollars for practices and hospital systems.  

Q: Will there be a time for the company to go international?

I have been asked this many of times there is always the interest of looking into the international market if it makes sense.  My goal is to make VC Medical Group a positive and impact influence to our Health Care first.  We feel we have a great opportunity to be involved in the push towards better preventative care.  

 

Q: If we’re sitting here a year from now celebrating what a great year it’s been for you in this role, what did we achieve together?

A: First, I want to celebrate my wife and kids, they believed in me and my vision.  Secondly, I want to impact our state in a way that we can help education recover, be apart of job creation and to have VC Medical be considered one of the most integrous companies in the country.

Q: Who is your role model, and why?

A: My dad is my biggest role model.  My real mother passed when I was 5 he brought me with him and his wife my earthly mother Donna Mae Bledsoe raised me and taught me so much.  I have made a TON of mistakes but my father has always believed in me and I wouldn’t here without him.  

Q: Why the name VC Medical?

A: My biological mother Vivian Campbell passed away and I was split from my sister Shannon so I could be raised by my dad.  I always wondered about my mother and when I got older I wanted to honor her so hence the name VC (Vivian Campbell) and I honor Jackie and Donna Mae Bledsoe by working this company and building it on the values they instilled in me.  God’s always had a plan for me and I am thankful he provided a way through my family for this to come to reality.  

Q: Any advice you would give to entrepreneurs?

A: My best piece of advice is this is not easy but if you really understand what you want your business to do it will allow you to make sound decisions.  If it’s only about the next million you will have many self inflicted wounds along your journey.