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SUMMER 2017

REGISTER NOW!VAFP 2017 Annual Meeting & Exposition

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Leesburg, VirginiaSEE PAGE 16

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VAFP Mission StatementThe mission of the VAFP is to empower its members to be personal physicians who provide high quality, accessible health care, dedicate themselves to the well-being of the citizens of Virginia, and are guided by the principle that the family physician is the specialist of choice for lifelong health care.

VAFP Vision StatementThe vision of the VAFP is for Virginia to be the best place for our citizens to receive their healthcare and for family physicians to practice medicine.

OFFICERSPRESIDENTLindsey D. Vaughn, M.D., FAAFP• Suffolk

PRESIDENT-ELECTRupen S. Amin, M.D., MBA, FAAFP• Harrisonburg

FIRST VICE-PRESIDENTDelmas J. Bolin, M.D., PhD, FAAFP• Roanoke

PAST PRESIDENTCharles O. Frazier, M.D., FAAFP• Williamsburg

TREASURERDena R. Hall, M.D.• Suffolk

SECRETARYRobert I. Elliott, M.D., FAAFP• Hurt

EXECUTIVE VICE PRESIDENTMary Lindsay White, MHA• Richmond

DIRECTORSEmmeline C. Gasink, M.D., FAAFP• Newport News

Neeta Goel, M.D.• Leesburg

David S. Gregory, M.D., FAAFP• Lynchburg

Susan D. Hundley, M.D.• Clarksville

Michelle E. Kingsbury, M.D., FAAFP• Virginia Beach

John Scott Litton, M.D., FAAFP• Pennington Gap

Daniel F. McCarter, M.D.• Nellysford

Jerry A. Provenzano, M.D.• Newport News

Brian K. Unwin, M.D., FAAFP• Roanoke

ADVISORSMSV DELEGATE

Lindsey D. Vaughn, M.D., FAAFP• Suffolk

MSV ALTERNATE DELEGATE

Rupen S. Amin, M.D., MBA, FAAFP• Harrisonburg

AAFP DELEGATES

Sterling N. Ransone, Jr., M.D., FAAFP• Deltaville

Jesus L. Lizarzaburu, M.D., FAAFP• Grafton

AAFP ALTERNATE DELGATES

E. Mark Watts, M.D., FAAFP• Vinton

Kent E. Willyard, M.D., FAAFP• Newport News

EX OFFICIO MEMBERSBrian Dickens, D.O.Virginia College of Osteopathic Medicine

Michael P. Jeremiah, M.D., FAAFPVirginia Tech Carilion School of Medicine

Anton J. Kuzel, M.D., FAAFPVirginia Commonwealth University

Christine C. Matson, M.D., FAAFPEastern Virginia Medical School

M. Norman Oliver, M.D.University of Virginia

The Virginia Family Physician is published by the Virginia Academy of Family Physicians1503 Santa Rosa RoadSuite 207Richmond, VA 23229

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VAFP 2017 Annual Meeting& Expositon

July 20-23, 2017Lansdowne ResortLeesburg, Virgnia

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Dear Colleagues,

So far, this year has started off well for our Academy, but 2017 still presents many challenges for Family Physicians. On a National level, many are concerned about the AHCA and most are just beginning the process of MACRA participation. On a state level, many are struggling with the recent changes by the Virginia Board of Medicine (VBOM) with narcotic prescribing. On a personal level, most Family Physicians are dealing with some element of “Burn Out.”

MACRA, even after recent efforts to simplify, remains a difficult concept to grasp for most physicians. MACRA/MIPS is being implemented in 2017, but will not have significant impact for another 2-3 years and may be tempting to ignore. However, if you have not yet developed a basic understanding of MACRA and MIPS, then I would strongly encourage you to review related VAFP magazine articles and visit both the AAFP and CMS education web sites concerning MACRA. There are other resources available such as utilizing Practice Transformation Networks (PTN’s), Clinically Integrated Networks (CIN’s) and Accountable Care Organizations (ACO’s). Dr. Amy Mullins, who is the AAFP Medical Director on Quality Improvement, will be speaking at the VAFP Annual Meeting at Lansdowne Resort and will also provide a workshop to answer questions about MACRA/MIPS.

In Virginia, the rate of death due to narcotic overdose continues to dramatically climb. This in part explains the changes in legislation and regulation over the past two years. We could argue on the impact of these changes, but we all know that something needs to be done. Governor McAuliffe and many of our legislators felt very strongly about acting on the problem as soon as possible, which led to the emergent implementation of the VBOM regulations concerning narcotic prescribing.

The recent changes, especially frequency of follow up and drug testing, as well as the requirements concerning use of Naloxone (Narcan), have left many of our members

uncertain as to how to best care for their patients receiving narcotics. A frequent response that I have heard is to simply stop prescribing narcotics. In a perfect world, we would all have a local pain management specialist willing to manage this aspect of care. Unfortunately, this does not exist within most of Virginia. At the end of the day, Family Physicians remain the best resource for providing high quality, evidence-based care for this patient population.

“Burn Out” continues to be a significant factor in the work lives of Family Physicians. The most recent reports estimate the number of Family Physicians suffering from burn out at approximately 60%, depression at 12-19% and the number of suicides annually at just over 400 (although thought to be much higher). “Loss of control” is often listed as a factor. Additional governmental requirements add to the existing list of production, scheduling and authorization stressors that many of us have to deal with.

“Work After Clinic,” often referred to as “WAC,” is a major factor. Most “WAC” has to do with completing EHR records. Recently, my group reviewed the typical hours when physicians utilize the EHR. Not surprisingly the “peak use” occurred between 5 pm and midnight. This has to stop! Answers are often complicated. A fairly simple approach is to delegate clerical work away from physicians to non-clinical providers and allowing clinical staff to work at their highest level of licensure. Within most offices, there are usually staff capable of performing much of the form completion and prior authorization work. A specific work-flow includes delegating nursing staff to download PMP reports for patients requiring a narcotic prescription.

By far the simplest approach that I have heard is to recognize that we, as physicians, were not well trained to perform most clerical work such as typing. We should allow ourselves to not always have perfect spelling and grammar. We should develop as many efficiencies as possible within our EHR. We should engage proficient providers to assist those that are struggling and to consider

developing scribes within our offices. Many VAFP members have been quite successful in doing so. We should reach out to our administrators and EHR vendors to help improve our experience. Fortunately, most health systems now recognize poor EHR experience as a primary cause for Burn Out.

There are many great resources to improve the Well-Being of Family Physicians. The AAFP is developing several programs including the “IMSAFE” program as well as sponsoring a “Renewal Conference” in Myrtle Beach next year. The AAFP is also working with the National Academy of Medicine (formerly the IOM) to work with EHR vendors in order to improve the EHR experience. Finally, the AAFP annual conference (FMX) has an educational section dedicated to Family Physician well-being. Additional resources include the AMA’s “Steps Forward” program which provides many great ideas to improve work-flow.

There are numerous publications on the issue of physician burn-out. Two often quoted experts on the subject also happen to be Family Physicians. They include Dr. Jay Winner, who wrote Relaxation On the Run, and Dr. Mark Greenawald (VAFP Past President and Chair of Carilion’s Professional Well-Being Committee). Dr. Greenawald has provided valuable insight through Podcasts and within several recent articles, including one in US News and World Report.

Finally, I remain in awe of the wonderful work that family physicians accomplish on a daily basis. I will leave you with a quote from a second century Athenian Physician which still seems relevant almost 2000 years later.

“These are the duties of a physician-First to heal his mind and give help to himself before giving it to anyone else”

Sincerely,

Lindsey Vaughn, MDVAFP President

VAFP President’s Message

Lindsey D. Vaughn, MD, FAAFP

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The Academy was greatly saddened to learn of the sudden passing of K. Marshall Cook, JD on Friday, April 14, 2017. Marshall was a friend, mentor and counselor to the VAFP for over 20 years and served as the VAFP’s General Counsel since 2001. His willingness to provide sound legal advice to VAFP members never wavered and his passion for serving the interests of physicians and health care providers was evident in every client interaction. Each quarter, Marshall provided the “FYI” article in the Virginia Family Physician magazine which reflected his informed perspective on pertinent topics that helped VAFP members practice “smart” medicine. His acumen for contract negotiations was unmatched and served many VAFP residents well in their endeavors to secure their first family medicine position.

Prior to starting his own private practice, Marshall was a partner with Hirschler Fleischer and served as counsel to the Medical Society of Virginia. He also served as Deputy Attorney General of Virginia from 1990 to 1993, leading the Commonwealth of Virginia’s efforts to pass legislation

that has allowed free clinics to flourish in Virginia and nationally. His work in establishing Virginia’s Good Samaritan law protecting volunteer physicians while

practicing in free clinics was a tremendous contributor to the growth of the free clinic sector in Virginia. This law became a model and an inspiration for other states to pass similar laws. Marshall also worked closely with the VAFP Legislative Committee and his legal opinions were instrumental

in the design of physician-led team care legislation governing the practice of mid-level providers in Virginia.

His peers named Marshall among Virginia’s “Legal Elite” in health law each year in Virginia Business magazine and he was regularly named a Virginia “Super Lawyer” in health law by Richmond magazine and among the Best Lawyers in America in the health care area. He also served as General Counsel for the Virginia Chiropractic Association.

Marshall was a devoted husband of 42 years to Sallie Hart Stone Cook; and doting father to his three daughters, Sarah, Elizabeth and Susan; and grandfather to five grandchildren, Katherine, Sallie, Douglas, Margaret (Maggie) and Henry. He was a devoted Christian and served as a deacon at Second Baptist Church in Richmond, VA. If not at the office, you would find him

surrounded by his family and grandchildren that he adored or down by the lake fishing.

Marshall will forever be remembered for his quick wit and warm smile. His loyalty to the VAFP as a valued client was unparalleled and will never be forgotten. Thank you, Marshall!

In Memoriam VAFP General Counsel K. Marshall Cook, JD

(April 14, 2017)

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Dr. Emerson Baugh graduated from the University of Virginia School of Medicine and interned at the Medical College of Virginia (now VCU School of Medicine). He began his solo practice of medicine in Kenbridge, Virginia, where he opened his office and his heart to the community in 1955. He practiced here for nearly 50 years. During that time, he treated snakebites, set broken bones, and repaired open wounds, while treating the spectrum of diseases and infirmities of all ages. He said that he followed patients through infancy, adulthood, and senility. House calls were the norm, and for many years he delivered babies in his office and homes. He delivered one baby on the ground in the patient’s yard and twice in the back seat of a car. Early on, he was the local dentist’s leading advocate and supporter in getting fluoride introduced to the Kenbridge water supply, a controversial concept in its day.

Dr. Baugh served on the Board of Directors of Lunenburg Health Service since 1956, an organization dedicated to providing free, supportive, compassionate nursing care to people in need

in Lunenburg County. He and his wife Helen Jane opened their home for many years, two weeks at a time, to medical students contemplating the family

physician way of life in a rural community. He was honored when asked to participate in this part of a med student’s education. He shared his calling with the students willingly, and enjoyed it thoroughly.

He was a Charter Fellow and Life Member of the American

Academy of Family Physicians and a four-time Diplomate to the American Board of Family Practice. He held many offices with the Virginia Academy of Family Physicians including President and was chosen the VAFP Family Physician of the Year in 1998. While he considered this to be the highest professional honor of his life, he never claimed to be anything but “a country doctor,” the title he preferred. This was his deeply satisfying and profoundly meaningful life’s work.

Dr. Dan loved the outdoors: the land, the woods and ponds of Southside Virginia, and the wildlife residing there. He loved fishing and hunting in all of these places with his boys and his friends whenever he could. He was a deep thinker with a sweet soul and a wonderful sense of humor. He gave generously to every charity that asked and many that did not. He spoke gently, he looked out for those less fortunate, especially children and the elderly, he laughed often, made others laugh, and he worked tirelessly, always putting the needs of others before his own. His dedication to his patients and his family and his community endeared him to multiple generations in Lunenburg.

In Memoriam VAFP Past President Emerson D. Baugh, Jr. MD

(May 9, 2017)

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VAFP Past President Sterling N. Ransone, Jr., MD Candidate for AAFP Board of Directors

The VAFP is proud to announce that Past President Sterling N. Ransone Jr., MD is running for Director on the AAFP Board of Directors. The election will take place during the 2017 AAFP Congress of Delegates, September 11-13, 2017 in San Antonio, TX.

Sterling N. Ransone, Jr, MD, FAAFP, is a board-certified Family Physician who

practices full-spectrum rural Family Medicine on the shores of the Chesapeake Bay in Deltaville, Virginia. He graduated from the College of William and Mary and the Medical College of Virginia, then completed his residency at the Riverside Family Medicine

Residency Program, serving as chief resident.

A third-generation family physician, Dr. Ransone returned to the area in which he was reared to serve the people of his community. Supporting his local area in numerous volunteer roles, including the local free clinic, hospice support

services, and sideline work as physician for the high school soccer and football teams, Sterling feels that the spirit of volunteerism is what makes society stronger.

He has served the community of medicine in numerous capacities, always believing that family physicians are the bedrock of health care in our country. He has aspired to improve the significance of all family physicians by serving on the Commission on Governmental Advocacy - to advocate our interests to the outside world; on the Commission on Membership and Member Services - to understand and advocate for the diverse constituencies within our Academy; and as a Delegate to the AAFP’s Congress of Delegates - to represent and be the voice for the interests of family physicians.

Dr. Ransone has held leadership positions in numerous national, state, and local organizations, most recently guiding physicians from all specialties as President of the Medical Society of Virginia. He has advocated for the interests of family physicians before legislative and regulatory bodies including local boards, the state legislature, and the halls of Congress. A former President of the Virginia Academy of Family Physicians, he believes in strong representation of the core values of Family Medicine at all levels of society.

Sterling grew up filing charts and scrubbing floors at the solo general practice of his father and is currently practicing as an employed physician in a large health care system beside his wife Karen A. Ransone, MD, FAAP, a pediatrician and former President of the Virginia Board of Medicine. They have three children: Elizabeth, a junior at William and Mary who will enter medical school in fall 2018; Katherine, who is studying at Christopher Newport University to be an environmental scientist; and Sterling III (Scooter), who graduates from high school in June 2017.

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Dear Colleagues,

Despite all that’s going on in Washington these days, MACRA remains

relatively unchanged. We should remember that MACRA was a bi-partisan

solution to the prior SGR payment system. I hope that the MACRA articles within

the VAFP magazine over the past year have been beneficial. My primary goal is

for all of our members to avoid the negative adjustment of 4% with the initial

payment in 2019.

The goal of this issue is to provide a basic method to avoid penalties under

the MIPS component of MACRA. In late 2016, CMS changed MIPS in response

to the concerns with implementation of such a complex program. The most

significant change had to do with “Pick Your Pace.” “Pick Your Pace” provides

three options in order to avoid penalties.

The simplest option is to report a single quality measure in 2017. On the next

page is an AAFP example that may benefit many small practices. In this case, Dr.

Jones, who has never submitted PQRS data, does not have an EHR and wants to

participate in the CMS Quality Payment Program (QPP), is guided through the

process of submitting measures on Hypertension.

If you plan to participate in the MIPS - QPP, please follow the example

and work to submit at least one quality measure for this year. If you still have

questions, please refer to the many resources on the AAFP and CMS websites,

contact the VAFP office, or better yet, attend the VAFP meeting this summer at

Lansdowne Resort.

Sincerely,

Lindsey

Lindsey Vaughn, MD

VAFP President

MACRA Letter

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MACRAPICK YOUR PACE

PRACTICE SCENARIO #1: TEST

Dr. Jones is a family physician in a small practice and has never reported to the Physician Quality Reporting System (PQRS) or the Medicare and Medicaid Electronic Health Records (EHR Incentive Program (also called Meaningful Use). He does not have an EHR, but he wants to start participating in Medicare’s Quality Payment Program (QPP) because he realizes he can’t afford the automatic negative adjustments if he does not report. He’s heard it should be easy to avoid the 2019 QPP negative payment adjustments by doing minimal reporting under one of the Pick Your Pace options in 2017. How should he begin participating in QPP?

RECOMMENDATION

Dr. Jones can avoid a 2019 negative adjustment by reporting as little as one measure for one patient in the quality category of the Merit-based Incentive Payment System (MIPS). Since he does not have an EHR, the most inexpensive way to report a quality measure will be through claims-based reporting. When reporting through claims, only Medicare Part B professional fee-for-service patients are reported (excludes Medicare Advantage and private payers). Dr. Jones follows these steps:

1. Dr. Jones goes to the QPP website’s list of 2017 quality measures(qpp.cms.gov). He filters the list by “Data Submission Method” and selects “Claims” from the drop down list. (See screenshot 1.)

He selects the quality measure “Controlling High Blood Pressure”(8 page PDF) from the list and clicks on the title to find the quality identification number (Quality ID: 236). (See screenshot 2.)Dr. Jones downloads the measure specifications for measure #236, found in the “Quality Measures Specifications” file on the QPP

Educational Resources(qpp.cms.gov) webpage. (See screenshot 3.)

2. Dr. Jones reads the measure specifications to thoroughly understand the instructions for reporting. He can use the measure flowchart as a decision tool.

a. This measure is to be reported

a minimum of once per performance period for patients with hypertension seen during the performance period.

b. The “DENOMINATOR” instructs that the measure is to be reported for patients who are 18-85 years of age with hypertension that was present within the first six months of

Pick Your PacePractice Scenario: Test

Screenshot 1

Screenshot 2

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the measurement period or any time prior to the measurement period.

c. The “NUMERATOR” for this measure includes patients whose blood pressure at the most recent visit is adequately controlled (i.e., systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg) during the measurement period. There are different quality data codes (QDC) that should be used, depending on the specific circumstances of each patient and exclusions. QDCs are CPT II or Level II G codes designed specifically for quality reporting.

3. Dr. Jones proceeds with seeing patients. During the day, a patient named Julie comes in for a visit. Julie has had hypertension for several years. She is 67 years old and enrolled in Medicare Part B. Therefore, Julie is eligible for the quality measure. The nurse flags Julie’s chart so Dr. Jones realizes this patient should be reported for QPP.

4. The nurse takes Julie’s blood pressure, which is 130/80. After the visit, the claim is prepared as usual. Hypertension, along with any other diagnoses, are recorded, and the evaluation and management (E&M) codes are added to the claim. In addition, the QDCs must be added prior to submitting the claim. Claims cannot be resubmitted to add QDC codes if they were omitted on the original claim.

a. Dr. Jones uses the measure flowchart to help him determine which

QDCs should be reported. He follows the logic and adds QDC G8752 since Julie’s systolic blood pressure is less than 140 and QDC G8754 since her diastolic blood pressure is less than 90.

b. The claim is submitted as usual.

EXPLANATION

Reporting at least one measure will protect Dr. Jones from the 2019 negative payment adjustment. Reporting additional measures will help increase his practice’s score in the quality performance category. Dr. Jones can report more than six measures. However, the six with the highest performance are the ones that count towards his quality category score. The more quality measures he reports that meet the data completeness criteria, the higher his score will be, and the higher his potential for a positive payment adjustment.

Each quality measure submitted will receive a baseline of three points. Measures reported for a continuous 90 days, with at least 20 patients, that include 50% of the denominator-eligible patients will be scored on performance. Performance will be compared to a benchmark and awarded 3 to 10 points. Download the 2017 quality measure benchmarks »(qpp.cms.gov)

EARNING ADDITIONAL POINTS

Dr. Jones could improve his MIPS final score by reporting measures and earning points in the improvement activities (IA) or advancing care information (ACI)

performance categories. Each of these categories has specific requirements.

To earn points in the IA category, Dr. Smith must attest to having performed at least one activity for a minimum of 90 days in 2017. Please see the QPP Improvement Activities(qpp.cms.gov) webpage for a list of improvement activities.

If Dr. Jones chooses to invest in an EHR, he must attest to at least the four required ACI measures in 2017 to earn points in the ACI category. Additional points can be earned for a high performance on ACI required and optional measures. Please see the QPP Advancing Care Information(qpp.cms.gov) webpage for a list of ACI measures.

Since Dr. Smith doesn’t have an EHR, he isn’t eligible to earn points under ACI, but could attest to performing one or more IAs for a minimum of 90 days. Please refer to the QPP Improvement Activities(qpp.cms.gov) webpage for a list of IAs.

OTHER REPORTING OPTIONS

Instead of submitting using claims, Dr. Jones could choose to use a qualified registry. However, there will likely be a charge associated with the use of a registry. CMS will publish a list of qualified registries later in 2017. Following the close of calendar year 2017, data will be submitted only once for the entire year when using a registry. With claims-based reporting, Dr. Jones needs to submit data for at least one measure, for at least one patient, to avoid the 2019 negative payment adjustment.

PREPARING FOR THE FUTURE

Claims-based reporting can be tedious and prone to error when used to report six measures. Some billing software offers assistance with quality reporting under claims, so Dr. Jones should check with his practice’s vendor to see if such assistance is available.

Without an EHR, he is limited in the options available for reporting. Other possibilities include using a qualified registry or a qualified clinical data registry (QCDR). Although, most QCDRs do require an EHR. Using a registry may better prepare Dr. Jones for full participation in QPP and success in the future.

Screenshot 3

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Nine family physicians represented the VAFP at the Annual Chapter Leadership Forum (ACLF) and the National Conference of Constituency Leaders (NCCL) April 27-29, 2017 in Kansas City, MO. VAFP President Lindsey Vaughn, MD, VAFP President-Elect Rupen Amin, MD, VAFP First Vice President Del Dolin, MD, PhD,

VAFP Past President and AAFP Delegate Sterling Ransone, MD and VAFP Past President, AAFP Delegate and Legislative Committee Chair Jesus Lizarzaburu, MD attended ACLF and Drs. Val Mutchler-Fornili, Susan Osborne, Rishika Kaundal, Verneeta Williams and Grace Chiu attended NCCL.

ACLF is the AAFP’s leadership

development program for chapter-elected leaders, aspiring chapter leaders, and chapter staff. Among other roles, ACLF functions as an orientation for emerging leaders who serve on chapter boards, as well as professional development for new and seasoned chapter staff. Drawing more than 200 attendees each year, ACLF also features targeted breakout sessions on chapter governance, advocacy, and communication.

NCCL is the AAFP’s leadership and policy development event for underrepresented constituencies. NCCL serves as a platform for different perspectives and concerns of AAFP members to help bring about change. The five constituencies with representation include: Women, Minorities, New physicians (in the first seven years of practice following residency), International Medical Graduates (IMG), from schools outside the U.S., Canada, and Puerto Rico and gay, lesbian, bisexual, and transgender (GLBT) physicians or physician allies. At NCCL, physicians develop skills to advocate for issues that are relevant to specific constituencies, practices, the specialty and patients.

VAFP Leaders Attend ACLF and NCCL

Pictured is the VAFP Delegation in attendance. Back row: Susan P. Osborne, DO, Verneeta L. Williams, MD, FAAFP , Lindsey D, Vaughn, MD, FAAFP, Sterling N. Ransone, Jr., MD, Jesus L. Lizarzaburu, MD, FAAFP, Delmas J. Bolin, MD, PhD, FAAFP. Front row: Valerie A. Mutchler-Fornili, MD and Grace Chiu, MD. Not Pictured: Rupen S. Amin, MD, MBA, FAAFP & Rishika Kaundal, MD.

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The opinions expressed in this article are those of the author and do not reflect the views of the Virginia Academy of Family Physicians.

When I was reviewing the ACA bill it seemed to me that it was about one thing and one thing only: creating jobs to help a weak economy. The only thing that we produce is “chronic disease.” The ACA was about creating jobs in IT, nursing, physical therapy, pharmaceutical sales, scribes, electronic medical records (which do not talk to each other) and exchanges. It was not about helping our citizens to have better health. But I digress.

The aftermath is that we have many people who have benefited from ACA. But it would seem that just as many have been hindered by it as well. We hear that because of the ACA, twenty million more Americans have insurance. What we do not hear is that they do not have access to care or medications, because they have

$3,000-5,000 high deductible plans. And for those of us whose rates have been raised so high, in order to subsidize the new insured, the cost is killing our local economies. Prices of medications have increased out of proportion to their cost. When a prescription hemorrhoid cream costs $120, you know we definitely have a problem.

Everyone I talk to about addressing the ACA say it is complex. Personally, I do not think it is complex at all. It is straight forward if we address the facts and we focus on the principles to solve the issues. We should ask: “What are we trying to accomplish?” It would seem that our citizens want to have affordable health care and health insurance. If that is the premise, then this may be accomplished with a four principle plan:

First, we need to clarify our discussions: Health care and health insurance are not the same thing.

They are not an interchangeable term. Health insurance is coverage for when unexpected medical issues develop. When someone develops type 2 diabetes, I would say this was not an accident. There were signs that this was a possibility. Once we have clarified the difference between insurance and healthcare, we can proceed with having mandatory catastrophic health insurance for all. There will be those who are high risk and perhaps too costly to insure, but we can then subsidize those individuals. High risk pools will be developed like it is done for car insurance. Also, fees will be based on individual risk and not of the employer. In other words, we will have to use actuaries. Just like with car insurance, behaviors are likely to change if your risk and fees are affected by behavior. Also, the catastrophic plan will include a preventive health assessment (or physical). This will be the opportunity to assess risk and enter the insurance pool.

Health insurance will be no different than car insurance. If you like to speed, have a ticket or a DUI, your car insurance price will reflect that. This makes you a bit more mindful of your driving. In addition, upkeep of your car such as an oil change, new tires or a tune-up are not things that we ask our insurance to pay for. If we did, our car insurance would become unaffordable. Car care is on the owner of the car.

Second, we need to address the fact that health insurance companies ARE NOT under the jurisdiction of the Federal Trade Commission. I bet most Americans do not know that the only government agency health insurances respond to is the Justice Department. Not quite the patient or consumer advocate we expect on any industry.

Third, there will be mandatory pricing transparency. This means all prices of all services, goods, hospital stays, surgeries, doctor visits and medications will be transparent. Insurances will no longer have to negotiate prices. Health plans can choose to pay for all, part or none of those services, based on the policy they sell to the consumer. Prices will be available so that patients (consumers) can find their best value. Say for example

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that a patient had a headache without any neurological red flags to indicate an MRI but the patient wants one, if prices were available, the patient may choose to pay out of pocket. People fear that prices for medical procedures will remain high, but the truth is that if insurance is not involved, prices drop. The simplest example is LASIK eye surgery and plastic surgery, neither of which is covered by

insurance. Both of those have continued to decline in price due to competition.

The fourth principle is accountability. There will be accountability of all involved in healthcare: health plans, suppliers, pharmaceuticals, hospitals, doctors, nurses, providers and patients. Yes, patients! I know many physicians feel that our patients can do no wrong, but I disagree. It is time our patients are

more involved and accountable. We have these discussions trying to provide healthcare which will benefit them without having them be accountable. I honestly think that without accountability, we will not solve anything.

As the ACA was being developed, no one could answer or address the following scenario: If someone with excellent insurance and access to care chooses not to ever get a health screening and develops a preventable cancer and now that someone wants to be treated, how is that fair to the rest of the pool of insureds? Everyone in that pool now has to pay for expensive treatments that may or may not work or improve quality of life. How is that fair or reasonable? So without addressing that question, our well-meaning past President and Congress extended insurance for more people to get late care when it is convenient for them.

As I get more grey hair, I find my patience getting shorter. I also find myself tired of dealing with plans that make us feel better for a bit instead of really providing solutions that will last. But then again, I am not running for office.

Jesus Lizarzaburu, MD

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The 4-principle solution builder:

1-Mandatory catastrophic health insurance for all. Subsidies will be in place for high risk individuals. No denial based on pre-existing conditions. A health assessment will be covered in order to enter the pool.

2-Health insurance companies will fall under the purview of the Federal Trade Commission, and they will be able to sell policies across state lines.

3-Health care prices for services will be transparent, as if you went to your local fast food place and looked at their menu.

4-Everyone involved will be accountable: health plans, suppliers, pharmaceuticals, hospitals, doctors, nurses, providers and patients.

16 17

Register Now!VAFP 2017 Annual Meeting

& Exposition July 20-23, 2017

Lansdowne Resort & Spa Leesburg, Virginia

To register visit www.vafp.org/annualmeeting

Call 1-877-419-8400 or visit the www.vafp.org/annualmeeting to make your reservations online.

The VAFP has negotiated an exceptional room rate of $185 per night. The cut-off date to make reservations is June 29, 2017. We highly recommend that reservations are secured as far in advance as possible. In the past, rooms have sold out prior to the cutoff date!

VAFP Members Attend the AAFP Family Medicine Advocacy Summit

On May 22-23, VAFP members joined family physicians from across the country in Washington, DC to attend the AAFP Family Medicine Advocacy Summit (FMAS). Attendees participated in educational sessions focused on family medicine’s legislative priority issues and learned how to lobby on Capitol Hill.

The legislative priority issues discussed included Healthcare Reform 2.0, Direct Primary Care, Telehealth, Physician-Focused and Advanced Payment Models, Teaching Health Centers and Immunizations for Vaccine Preventable Diseases.

VAFP members in attendance included Teodora G. Brose, MD, Lynchburg; Cecily D. Havert, MD, Arlington; Jesus L. Lizarzaburu, MD, FAAFP, Yorktown; Sterling N. Ransone, MD, FAAFP, Deltaville; Daniel Salmeron, MD, MSPH, FAAFP, Reston; Richard F. Stowers, MD, FAAFP, Huddleston; and Sebastian Tong, MD, MPH, Richmond.

Following the educational sessions, attendees had the opportunity to visit with Senators Tim Kaine and Mark Warner and Representatives Donald McEachin, Tom Garrett, Robert Goodlatte, Scott Taylor and Don Beyer.

The VAFP very much appreciates members representing family medicine interests on behalf of all Academy members.

FMAS attendees pictured at the US Capitol.

16 17

At Johnston Memorial Hospital, we strive to provide an environment in which physicians and families will grow and thrive. You'll be surrounded by other regionally-known physicians and a supportive management team as well as an expert and caring sta� of nurses and technicians. State-of-the-art technology that you need for success in your practice is all available. You and your family will enjoy a high standard of living in this community, surrounded by the beautiful mountains, the lush scenery, the friendly neighborhoods, and the rich culture and history of Abingdon.

Nestled in the Virginia Highlands, Abingdon is within driving distance of Roanoke, Asheville, Knoxville, and Nashville and is home to an excellent school system and a wealth of social, community, and religious organizations. This small town is known for bigger-city amenities. If you're seeking the perfect balance of personal and professional growth, you won't �nd a better home than Johnston Memorial Hospital.

• Competitive Annual Salary (Earning potential up to $300K)• Employment through MSMG/HIMA• Production Bonus based on Work RVUs• Performance Bonus• Excellent Bene�ts and Paid Malpractice• Pleasant Working Conditions• Generous Sign On Bonus• Relocation and Educational Loan Assistance• Work within Brand New Hospital which opened July 2011• Stable and Unique Group• 7 on 7 o� Schedule• 6 Physician Extenders to assist with discharges, prescriptions, rounding and communication �ow with PCP• Teaching and Faculty opportunities with the JMH FM/IM Residency Training Programs• Critical Care Physicians Covering CCU/PCU

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18 19

Inpatient Detox

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Partial Hospitalization

Intensive Outpatient Programs

Opioid Treatment Program Office-based

Opioid Treatment

Case Management

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• An estimated 1,079 Virginians died from opioid overdoses in 2016. • Medicaid members are prescribed opioids at twice the rate of non-Medicaid members and are at

three-to-six times the risk of prescription opioid overdose. • The Medicaid ARTS benefit was funded in the 2016 Appropriations Act with bipartisan support

from the Governor and General Assembly to expand access to life-saving addiction treatment.

The ARTS Program provides the full continuum of evidence-based addiction treatment.

• The ARTS benefit will provide the full continuum of evidence-based addiction treatment to any of the 1.1 million Medicaid and FAMIS members who need treatment.

• The ARTS program “carves in” the community-based addiction treatment services into Managed Care Organizations (MCOs) to promote full integration of physical health, traditional mental health, and addiction treatment services.

• The ARTS waiver approved by CMS allows DMAS to draw down new federal matching funds for residential treatment facilities with > 16 beds, significantly increasing treatment capacity.

Rate of Fatal Opioid Overdose (Fentanyl, Heroin, and/or RX) per 100,000

18 19

• Increased Medicaid rates under ARTS catalyzed a dramatic increase in addiction treatment providers. • These providers will serve all Virginians with addiction, not just Medicaid members.

Preliminary Increases in Medicaid Addiction Provider Network Due to ARTS

Post-ARTS Medicaid Addiction Provider Network in the Commonwealth

For more information, please visit: http://www.dmas.virginia.gov/Content_Pgs/bh-sud.aspx

To ask questions or to let us know you would like to join a stakeholder distribution list, please email us at SUD@dmas.virginia.gov.

20 21

• Approved the minutes from the February 4, 2017 VAFP Board of Directors meeting held in Wintergreen, Virginia.

• Heard report from VAFP Treasurer Dena Hall, MD on fiscal year 2016.

• Approved the 2016 VAFP audit.

• Heard report from VAFP Legislative Committee Chair Jesus Lizarzaburu, MD and VAFP Legislative Representative Hunter Jamerson, JD on the 2017 General Assembly to include Direct Primary Care, the new opioid prescribing regulations and the ER care coordination software implementation.

• Discussed the 2018 VAFP legislative priorities to include prior authorization, scope of practice and step therapy.

• Hear report from VAFP CME Committee Chair Mitch Miller, MD on the plans and programming for the 2017 VAFP Annual Meeting & Exposition scheduled July 20-23, 2017 at Lansdowne Resort in Leesburg, VA.

• Discussed options for the location and dates of the 2018 VAFP Annual Meeting and Exposition.

• Heard report on the Resident and Student meetings held

in conjunction with the 2017 Winter Family Medicine Weekend.

• Heard update from VAFP GME Task Force Chair Roger Hofford, MD regarding the Doctor of Medical Science issue and the 2017 National Family Medicine Resident Matching Program results.

• Heard report from AAFP Delegate Sterling Ransone, MD on the work he is doing with the AAFP Commission on Membership & Member Services.

Virginia Academy of Family PhysiciansBoard of Directors Meeting

April 8, 2017

20 21

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ACTIVE

Jessica Akunna, MD

David Amos, MD

Claudia Anglade, MD

Joel Okechukwu Anyiwo, MD

Victor Appiah, MD

Alicia S. Barnes, DO

Aneesa Batool, MD

Ingrid Anderson Beck, MD

Aliona Bortun, MD

Elizabeth Whitney Brawner, MD

Kathryn J. Brokus, DO

Teodora G. Brose, MD

Sareena Pabla Brown, MD

Tiffany A. Brown, MD

Sherry Bernita Brown, MD

Veena Chawla, MD

Alison Collins, DO

Kevin Patrick Cooke, MD

Zachary Devilbiss, DO

Anna L. Dunn, DO

Gabriel Lee Edmondson, DO

Jennie Marie Emery, DO

Chineme Enyioha, MD

Jasmine Althea Finch, MD

Sandra Kay Fleming, MD

Abel Moreno Flores, MD

Corina Freitas, MD, MBA, MSC

Muteeb Ghaffar, MD

Harrison Gimbel, MD

Mark Haggerty, DO

Katherine Elizabeth Harris, DO

Brandon Haubner, DO

Brittany Hayes, DO

Clare Hector, MD

Steven Hilton, DO

Kimberly Anne Hlavac, MD

Stephanie Carrier Hodges, MD

Jonathon Cooper Hodges, MD

Cecilia Balocco House, DO

Monica Luu Quach Hwang, MD

Sam Hwu, MD

Akolea Kekahuli Ioane, MD

John Francis Keenan, MD

Rucha Rajendra Kharwa, MD

Christopher Jay Kim, MD

Hayoon Kim, MD

Chandrasekhar Kommu, MD

Steven Lam, MD

Brittany Marie Larson, MD

Hansel Eliott Lee, MD

Jonathan Lekoshere, DO

Amanda Rose Liggett, MD

Jeanne Lumpkin, MD

Lauri Ann Maitland, DO, MPH

Robert Makishi, MD

Qudsia Iqbal Malik, MD

Nitish Jasmine Manning, MD

Stephanie Danielle Marzola, MD

Sarah M. Mazanec, DO

Mehwish Moktader, DO

Gabriel Loren Mosier, MD

Jonathan D. Moss, MD

Peter William Murphy, MD

Vincent John Nardone, MD

Van Thi Nguyen, MD

Terry Nam Nguyen, DO

Edward Orshansky, MD

Juan Carlos Ortiz, MD

Paige Kimbrell Parker, DO

Michael James Perry, MD

Elizabeth Allison Powers, MD

Parineeta Shiva Rao, MD

Curtis John Read, DO

Meredith Lynn Richmond, MD

Levi Rizk, DO

Takisha Rochelle Robinson, MD

Gerohnda L. Rushton, DO

Jonathan C. Saks, MD

Sharayu R. Sawant, MD

Jonathan Tyler Schaaf, MD

Tobey Jean Schultz, DO

Pamela Cruz Scott, MD

Sabrina Kaur Sikka, MD

Rupali Singla, MD

Falishia Michelle Sloan, MD

William C. Stallard, MD

Thomas William Stallard, MD, MBChB

Maria Chanel Stevens, MD

Nicholas Patrick Strasser, DO

Eleanor Tanno, MD

Jelisa A. Timmons, MD

Carol Thuy Vy Tran, MD

Vi Le Tran, MD

Wesley Chad Turner, DO

Susette Var, MD

Randy Villarreal, MD

Flint Robert Taitano Walker, DO

Lishan Jhanealle Walker, MD

Brian Igoni Wariboko, MD

Kirsten Anne Wiitala, MD

Kevin P. Wolf, DO

THE VAFP WELCOMES NEW MEMBERS

22 23

New Me

mbers

David Michael Woodson, DO

Makoto Michael Yoshino, DO

RESIDENT

Helen Goggans Arnold, DO

James Flinn Donecker, MD

Joshua Alexander Yager, MD

Asia B. Zierle-Ghosh, DO

STUDENT

Taylor Jones

Nabil Kareem Abazaid

Christopher Armstrong

John Baker

Akta Bhukhen

John Bishop

William Brock

Ryan Scott Canter

Michelle Choi

Jay C. Clark

Bryce Clinger

Craig A. Cromer

Russell W. Davis, III

Kelsey Maryanna Delph

Rahim Dhanani

Lindsey Dove

Nicholas Dreyer

Riley Ewen

Michael Andrew Fox

Mary Gallagher

Calvin Gao

Veer Gariwala

Jose George

Brielle Gerry

Allie Gurlitz

Jasmine Hall

Amatul-Akhir Haneef

Sharmeen Husain

Melissa Huynh

Arjun Jogimahanti

Ryan Johnson

Meghana Kaloji

Samuel Kessel

Jinho Kim

Deepika Kunnath

Nisha Kuruvadi

Andrew Lam

Jeong Hoo Lee

Lisa Xiang Li

Caroline Liu

Sichen Liu

Jewel Llamas

Andrew Ma

Christian Machado

Rida Malick

Patrick Marvil

Ankita Mathur

Matthew Mikula

Benjamin Mitchell

Paulius Mui

Thomas Neal

David Nehring

Danny Ngo

Jessica Nieto

Cameron Oldham

Emily Olivares

Jennifer O’Neil

Vatsal Patel

Sergio Patton

Melanie Pham

Donna K. Phan

John Raduka

Jesus Ramirez

Jocelyn Carroll Ray

Brian Reon

Claire Marie Repine

Matthew Rich

Christina Rodriguez

Seungwhan Roh

Julia Ross

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Ellen Shaffrey

Won Seok Shin

Moira Smith

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Jon Suzich

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Trish Tran

Kenny Hung Vo

John Wallace

Connor Wang

Eric Waselewski

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24 25

Resident & Student Corner 2017 NATIONAL CONFERENCE OF

FAMILY MEDICINE RESIDENTS AND

MEDICAL STUDENTS

July 27 - July 29, 2017 - Kansas City Convention CenterKansas City, MO

National Conference is the place for residents and medical students to learn more about family medicine, explore residency programs, and connect with potential employers.

For Students:• Educational Programming: Attend

workshops, musculoskeletal clinics, procedural skills courses, and sessions about applying to residency and maternal care and childbirth.

• Expo Hall: Have access to hundreds of residency programs in the same place, saving you the hassle and expense of visiting each one.

• Connections: Meet like-minded individuals who are passionate about family medicine through networking sessions and special events.

• Leadership Opportunities: Expand your leadership skills by participating in the Student Congress.

For Residents:• Educational Programming: Learn

about the process of successfully transitioning into practice from residency.

• Expo Hall: Meet with future employers, fellowship programs, and more to explore post-residency opportunities.

• Connections: Network with other residents, practicing physicians, and family medicine leaders through sessions and special events.

• Leadership Opportunities: Expand your leadership skills by participating in the Resident Congress.

More information can be found at www.aafp.org/events/national-conference.

“CHOOSE VIRGINIA” SCHOLARSHIPS

“Choose Virginia” Scholarships for Graduating Medical Students and Family Medicine ResidentsThe Virginia Academy of Family Physicians (VAFP) Foundation is delighted to offer a medical student scholarship and a resident scholarship in 2017 for assistance with education loan repayment. Many medical students and family medicine residents in Virginia have expressed an interest in staying in Virginia after their graduation to complete a family medicine residency or to practice in a medically underserved area. Over the past two years the VAFP Foundation has received donations to support this effort to keep our own.

This year the Foundation will offer one graduating Virginia medical student a $1,000 scholarship. The successful candidate will meet the following criteria:

• Graduating Virginia medical student in good academic standing.

• Entering a Virginia family medicine residency program. A letter from the program director is required.

• Will have completed the PGY-1 year successfully and be entering into the PGY-2 year at that program. A letter from the program director is required in order to receive the scholarship check for loan repayment at that time.

• Must submit a 250-500 word letter explaining why he/she wants to practice family medicine in Virginia as a resident and as a family physician.

In addition, we are offering one $1,500 scholarship for a graduating PGY-3 Virginia family medicine resident who wishes to practice in an underserved area of Virginia. The requirements for this scholarship are as follows:

• Graduating as a PGY-3 Virginia family medicine resident.

• Have an up-to-date Virginia medical license.

• Practicing family medicine in an underserved medical area after graduation as designated by United States Human Resource Service Administration (HRSA) and/or Virginia Department of Health. A letter verifying this is required.

• Must submit a 250-500-word letter explaining why they he/she wants to practice in an underserved area of Virginia.

• Practicing at the underserved site for one year. Documentation is necessary to receive the scholarship check for loan repayment after one year of practice in an underserved area.

Application letters may be sent to Mrs. Mary Lindsay White at mlwhite@vafp.org or to Dr. Roger Hofford at rahofford@carilionclinic.org. The deadline for application letters is June 30, 2017.

CAREER CENTER CHOOSE VIRGINIA

The premier resource for you to explore employment opportunities in Virginia. Visit http://careercenter.vafp.org to access the VAFP Career Center.

If you have any questions, please do not hesitate to contact the VAFP at 804-968-5200 or email Matt Schulte at mschulte@vafp.org.

24 25

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26 27

CMECME Calendar2017

July 20-23, 2017VAFP 2017 Annual Meeting & ExpositionLansdowne Resort & Spa - Leesburg

Saturday, September 30, 2017Medical Genomics KSA (morning session)Note: There is not a CSA available for this topic.Charlottesville

Saturday, September 30, 2017Part IV Performance in Practice Module: Critical Thinking for Quality Improvement in Clinical Care (afternoon session)Charlottesville

Saturday, October 28, 2017Depression KSA/CSALynchburg

Saturday, November 11, 2017Cerebrovascular Disease KSA/CSA (morning session)Richmond

Saturday, November 11, 2017Depression KSA/CSA (afternoon session)Richmond

2018

January 25-28, 2018VAFP 2018 Winter Family Medicine WeekendWintergreen Resort – Wintergreen

Visit www.vafp.org for more information.

Virginia Academy of Family Physicians FoundationSupport Family Medicine

For more information on the VAFP Foundation, please visit www.vafpf.org or call 1-800-THE-VAFP. Secure donations can be made online at www.vafpf.org or checks can be mailed to the VAFP office.

The VAFP is pleased to provide as a membership benefit a free subscription to Daily POEMs from Essential Evidence Plus. Daily POEMs (Patient Oriented Evidence that Matters) alerts and 3,000+ archived POEMs help you stay abreast of the latest and most relevant medical literature. Delivered directly to you by e-mail every Monday through Friday, Daily POEMs identify the most valid, relevant research that may change the way you practice. Monthly, the complete set is compiled and sent for additional summary review. Ongoing since 1996, their editors now review more than 1,200 studies monthly from more than 100 medical journals, presenting only the best and most relevant as POEMs. The acclaimed POEMs process applies specific criteria for validity and relevance to clinical practice. If you want to subscribe, please e-mail the VAFP at cmodesto@vafp.org so your e-mail address can be added to the

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TRESIBA® (insulin degludec injection)Rx OnlyBRIEF SUMMARY. Please consult package insert for full prescribing information.INDICATIONS AND USAGE: TRESIBA® is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis; Not recommended for pediatric patients requiring less than 5 units of TRESIBA®

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Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including TRESIBA®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). TRESIBA®, or any insulin, should not be used during episodes of hypoglycemia. Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia. Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of TRESIBA® may vary among different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Risk Mitigation Strategies for Hypoglycemia: Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. Hypoglycemia Due to Medication Errors: Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between TRESIBA® and other insulins, instruct patients to always check the insulin label before each injection. Do not transfer TRESIBA® from the TRESIBA® pen to a syringe. The markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia [see Warnings and Precautions]. Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including TRESIBA®. If hypersensitivity reactions occur, discontinue TRESIBA®; treat per standard of care and monitor until symptoms and signs resolve. TRESIBA® is contraindicated in patients who have had hypersensitivity reactions to insulin degludec or one of the excipients. Hypokalemia: All insulin products, including TRESIBA®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). Fluid Retention and Congestive Heart Failure with Concomitant Use of a PPAR Gamma Agonist: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists can cause dose related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients treated with insulin, including TRESIBA® and a PPAR-gamma agonist should be observed for signs and symptoms of congestive heart failure. If congestive heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

ADVERSE REACTIONS: The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions] ; Hypersensitivity and allergic reactions [see Warnings and Precautions] ; Hypokalemia [see Warnings and Precautions]. Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TRESIBA® in subjects with type 1 diabetes or type 2 diabetes was evaluated in nine trials of 6-12 month duration in adults and in one trial of 12-month duration in pediatric patients 1 year of age and older with type 1 diabetes. The data in Table 1 reflect the exposure of 1102 adults with type 1 diabetes to TRESIBA® with a mean exposure duration to TRESIBA® of 34 weeks. The mean age was 43 years and 1% were older than 75 years. Fifty-seven percent were male, 81% were White, 2% were Black or African American and 4% were Hispanic. The mean body mass index (BMI) was 26 kg/m2. The mean duration of diabetes was 18 years and the mean HbA1c at baseline was 7.8%. A history of neuropathy, ophthalmopathy, nephropathy and cardiovascular disease at baseline was reported in 11%, 16%, 7% and 0.5% respectively. The mean eGFR at baseline was 87 mL/min/1.73 m2 and 7% of the patients had an eGFR less than 60 mL/min/1.73 m2. The data in Table 2 reflect the exposure of 2713 adults with type 2 diabetes to TRESIBA® with a mean exposure duration to TRESIBA® of 36 weeks. The mean age was 58 years and 3% were older than 75 years. Fifty-eight percent were male, 71% were White, 7% were Black or African American and 13% were Hispanic. The mean BMI was 30 kg/m2. The mean duration of diabetes was 11 years and the mean HbA1c at baseline was 8.3%. A history of neuropathy, ophthalmopathy, nephropathy and cardiovascular disease at baseline was reported for 14%, 10%, 6% and 0.6% of participants respectively. At baseline, the mean eGFR was 83 mL/min/1.73 m2 and 9% had an eGFR less than 60 mL/min/1.73 m2. Common adverse reactions (excluding hypoglycemia) occurring in TRESIBA® treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively. Common adverse reactions were defined as reactions occurring in ≥5% of the population studied. Hypoglycemia is not shown in these tables but discussed in a dedicated subsection below. 174 pediatric patients 1 year of age and older with type 1 diabetes were exposed to TRESIBA® with a mean exposure to TRESIBA® of 48 weeks. The mean age was 10 years: 25% were ages 1-5 years, 40% were ages 6-11 years, and 35% were ages 12-17 years. 55.2% were male, 78.2% were White, 2.9% were Black or African American and 4% were Hispanic. The mean body mass index (BMI) was 18.7 kg/m2. The mean duration of diabetes was 3.9 years and the mean HbA1c at baseline was 8.2%. Common adverse reactions in TRESIBA® treated pediatric patients with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1.

Table 1: Adverse Reactions Occurring in ≥5% of TRESIBA®-Treated Adult Patients with Type 1 Diabetes Mellitus

Adverse ReactionTRESIBA® (n=1102)

Nasopharyngitis 23.9 %

Upper respiratory tract infection 11.9 %

Headache 11.8 %

Sinusitis 5.1 %

Gastroenteritis 5.1 %

Table 2: Adverse Reactions Occurring in ≥5% of TRESIBA®-Treated Adult Patients with Type 2 Diabetes Mellitus

Adverse ReactionTRESIBA® (n=2713)

Nasopharyngitis 12.9 %

Headache 8.8 %

Upper respiratory tract infection 8.4 %

Diarrhea 6.3 %

Hypoglycemia: Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including TRESIBA® [see Warnings and Precautions]. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for TRESIBA® with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice. The percentage of adult and pediatric patients with type 1 diabetes randomized to TRESIBA® who experienced at least one episode of hypoglycemia in clinical trials and adults with type 2 diabetes are shown in Tables 3 and 4, respectively. No clinically important differences in risk of hypoglycemia between TRESIBA® and long-acting insulin comparators were

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observed in clinical trials conducted in adult patients. Severe hypoglycemia in trials with adult patients was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe hypoglycemia in the pediatric trial was defined as an altered mental status where the child could not assist in his own care, was semiconscious or unconscious, or in a coma ± convulsions and may require parenteral therapy (glucagon or intravenous glucose). A Novo Nordisk hypoglycemia episode was defined as a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).

Table 3: Percent (%) of Type 1 Diabetes Patients Experiencing at Least One Episode of Severe Hypoglycemia or Novo Nordisk Hypoglycemia§ on TRESIBA® in Adult and Pediatric Clinical Trials

Study A Adults

+ insulin aspart

52 weeks

Study B Adults

+ insulin aspart

26 weeks

Study C Adults

+ insulin aspart 26 weeks

Study J Pediatrics + insulin aspart

52 weeks

TRESIBA® (N=472)

TRESIBA® (N=301)

TRESIBA® at the same time each

day (N=165)

TRESIBA® at alternating

times (N=164)

TRESIBA® (N=174)

Severe hypoglycemia*Percent of patients 12.3% 10.6% 12.7% 10.4% 17.8%

Novo Nordisk hypoglycemia§

Percent of patients 95.6% 93.0% 99.4% 93.9% 98.3%

*Severe hypoglycemia in pediatric patients: an episode with altered mental status, where the child could not assist in his own care, was semiconscious or unconscious, or in a coma ± convulsions and may require parenteral therapy (glucagon or intravenous glucose). §Novo Nordisk hypoglycemia: a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).

Table 4: Percent (%) of Patients with Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia or Novo Nordisk Hypoglycemia§ on TRESIBA® in Adult Clinical Trials

Study D + 1-2

OADs* insulin naïve

52 weeks

Study E + 1-2

OADs* insulin naïve

26 weeks

Study F ± 1-3

OADs* insulin naïve

26 weeks

Study G T2DM ± 0-3 OADs*

26 weeks

Study H T2DM ±

0-2 OADs* + insulin aspart

52 weeks

Study I T2DM ±

1-2 OADs* insulin naïve

26 weeks

TRESIBA® (N=766)

TRESIBA® (N=228)

TRESIBA® (N=284)

TRESIBA® (N=226)

TRESIBA® (alternating

time) (N=230)

TRESIBA® (N=753)

TRESIBA® (N=226)

Severe HypoglycemiaPercent of patients

0.3% 0 0 0.9% 0.4% 4.5% 0.4%

Novo Nordisk Hypoglycemia§

Percent of patients

46.5% 28.5% 50% 43.8% 50.9% 80.9% 42.5%

*OAD: oral antidiabetic agent, §Novo Nordisk hypoglycemia: a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).

Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including TRESIBA® and may be life threatening [see Warnings and Precautions]. Hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching) and urticaria were reported in 0.9% of patients treated with TRESIBA®. Lipodystrophy: Long-term use of insulin, including TRESIBA®, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy. In the clinical program, lipodystrophy, lipohypertrophy, or lipoatrophy was reported in 0.3% of patients treated with TRESIBA®. Injection Site Reactions: Patients taking TRESIBA® may experience injection site reactions,

including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. In the clinical program, injection site reactions occurred in 3.8% of patients treated with TRESIBA®. Weight Gain: Weight gain can occur with insulin therapy, including TRESIBA®, and has been attributed to the anabolic effects of insulin. In the clinical program after 52 weeks of treatment, patients with type 1 diabetes treated with TRESIBA® gained an average of 1.8 kg and patients with type 2 diabetes treated with TRESIBA® gained an average of 3.0 kg. Peripheral Edema: Insulin, including TRESIBA®, may cause sodium retention and edema. In the clinical program, peripheral edema occurred in 0.9% of patients with type 1 diabetes mellitus and 3.0% of patients with type 2 diabetes mellitus treated with TRESIBA®. Immunogenicity: As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to TRESIBA® with the incidence of antibodies in other studies or to other products, may be misleading. In studies of adult type 1 diabetes patients, 95.9% of patients who received TRESIBA® once daily were positive for anti-insulin antibodies (AIA) at least once during the studies, including 89.7% that were positive at baseline. In studies of type 2 diabetes patients, 31.5% of patients who received TRESIBA® once daily were positive for AIA at least once during the studies, including 14.5% that were positive at baseline. The antibody incidence rates for type 2 diabetes may be underreported due to potential assay interference by endogenous insulin in samples in these patients. The presence of antibodies that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper or hypoglycemia. The incidence of anti-insulin degludec antibodies has not been established.DRUG INTERACTIONS: Table 5 includes clinically significant drug interactions with TRESIBA®.

Table 5: Clinically Significant Drug Interactions with TRESIBA®

Drugs That May Increase the Risk of HypoglycemiaDrugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking

agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors.

Intervention: Dose reductions and increased frequency of glucose monitoring may be required when TRESIBA® is co-administered with these drugs.

Drugs That May Decrease the Blood Glucose Lowering Effect of TRESIBA®

Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.

Intervention: Dose increases and increased frequency of glucose monitoring may be required when TRESIBA® is co-administered with these drugs.

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of TRESIBA®

Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when TRESIBA® is co-administered with these drugs.

Drugs That May Blunt Signs and Symptoms of HypoglycemiaDrugs: Beta-blockers, clonidine, guanethidine, and reserpine

Intervention: Increased frequency of glucose monitoring may be required when TRESIBA® is co-administered with these drugs.

USE IN SPECIFIC POPULATIONS: Pregnancy: Risk Summary There are no available data with TRESIBA® or insulin degludec in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Rats and rabbits were exposed to insulin degludec in animal reproduction studies during organogenesis. Pre-and post-implantation losses and visceral/skeletal abnormalities were observed in rats at doses 5 times (rat) and at 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. These effects were similar to those observed in rats administered human insulin (NPH) [see Data]. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies

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is 2-4% and 15-20%, respectively. Clinical Considerations: Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data: Animal Data: Insulin degludec was investigated in studies covering fertility, embryo-fetal development and pre- and post-natal development in rats and during the period of embryofetal development in rabbits. Human insulin (NPH insulin) was included as comparator. In these studies insulin degludec caused pre- and post-implantation losses and visceral/skeletal abnormalities when given subcutaneously at up to 21 U/kg/day in rats and 3.3 U/kg/day in rabbits, resulting in 5 times (rat) and 10 times (rabbit) the human exposure (AUC) at a human subcutaneous dose of 0.75 U/kg/day. Overall, the effects of insulin degludec were similar to those observed with human insulin, which were probably secondary to maternal hypoglycemia. Lactation: Risk Summary: There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. Insulin degludec is present in rat milk [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRESIBA® and any potential adverse effects on the breastfed infant from TRESIBA® or from the underlying maternal condition. Data: In lactating rats, insulin degludec was present in milk at a concentration lower than that in plasma. Pediatric Use: The safety and effectiveness of TRESIBA® to improve glycemic control in type 1 and type 2 diabetes mellitus have been established in pediatric patients 1 year of age and older. The safety and effectiveness of TRESIBA® have not been established in pediatric patients less than 1 year old. The use of TRESIBA® in pediatric patients 1 year of age and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study (studies included pediatric patients 1 year of age and older with type 1 diabetes mellitus). The use of TRESIBA® in pediatric patients 1 year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. In pediatric patients 1 year of age and older already on insulin therapy, start TRESIBA® at a reduced dose to minimize the risk of hypoglycemia. Geriatric Use: In controlled clinical studies a total of 77 (7%) of the 1102 TRESIBA® -treated patients with type 1 diabetes were 65 years or older and 9 (1%) were 75 years or older. A total of 670 (25%) of the 2713 TRESIBA®-treated patients with type 2 diabetes were 65 years or older and 80 (3%) were 75 years or older. Differences in safety or effectiveness were not suggested in subgroup analyses comparing subjects older than 65 years to younger subjects. Nevertheless, greater caution should be exercised when TRESIBA® is administered to geriatric patients since greater sensitivity of some older individuals to the effects of TRESIBA® cannot be ruled out. The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be more difficult to recognize in the elderly. Renal Impairment: In clinical studies a total of 75 (7%) of the 1102 TRESIBA®-treated patients with type 1 diabetes had an eGFR less than 60 mL/min/1.73 m2 and 1 (0.1%) had an eGFR less than 30 mL/min/1.73 m2. A total of 250 (9%) of the 2713 TRESIBA®-treated patients with type 2 diabetes had an eGFR less than 60 mL/min/1.73 m2 and no subjects had an eGFR less than 30 mL/min/1.73 m2. No clinically relevant difference in the pharmacokinetics of TRESIBA® was identified in a study comparing healthy subjects and subjects with renal impairment including subjects with end stage renal disease. However, as with all insulin products, glucose monitoring should be intensified and the TRESIBA® dosage adjusted on an individual basis in patients with renal impairment. Hepatic Impairment: No difference in the pharmacokinetics of TRESIBA® was identified in a study comparing healthy subjects and subjects with hepatic impairment (mild, moderate, and severe hepatic impairment). However, as with all insulin products, glucose monitoring should be intensified and the TRESIBA® dosage adjusted on an individual basis in patients with hepatic impairment.OVERDOSAGE: An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.More detailed information is available upon request.

Date of Issue: 12/2016 Version: 4 Novo Nordisk®, TRESIBA®, FlexTouch®, LEVEMIR®, NOVOLOG®, NovoFine® and NovoTwist® are registered trademarks of Novo Nordisk A/S.PATENT Information: http://novonordisk-us.com/patients/products/product-patents.htmlManufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, DenmarkFor information about TRESIBA® contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-800-727-6500 www.novonordisk-us.com© 2017 Novo Nordisk USA16TSM05266 2/2017

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The Virginia Academy of Family Physicians1503 Santa Rosa RoadSuite 207Richmond, VA 23229

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