c m s bulletin - allegheny county medical society2019/07/15 · 2015 vijay k. bahl patricia l....

BulletinAllegheny County MediCAl SoCiety

Raising melanoma awareness

Meet your 2015 president

MAy 2015

hh-law.com

Business • Employment • Estates and Trusts • Health Care Litigation • Oil and Gas • Public Finance • Real Estate

Care is Your Business, Change is OursThe healthcare environment is changing. Physicians must focus on providing the highest quality care with intense competition for their time. Medical practices face increased challenges tied to changes to regulation, insurance protocols, cost-management and revenue management.

Houston Harbaugh has over 30 years of experience in helping physicians and medical practices manage change through contract negotiations with hospitals and payors; contract management; advocacy and new practice start-up counsel. We have provided critical support in practice mergers and acquisitions. And we have provided sound advocacy on issues ranging from HIPAA compliance to medical staff and peer review matters.

Every challenge a medical practice can face, we have seen. We have helped practices of all size and structure meet these challenges. And we know what is ahead.

BulletinMAy 2015 / Vol. 105 No. 5

Allegheny County MediCAl SoCiety

ArtiCleS PerSPeCtiveS dePArtMentS

Materia Medica .................... 204Technosphere insulin (Afreeza®): a new, inhaled prandial insulinTucker Freedy, PharmD, BCPS

Legal Report ....................... 210Part-time buprenorphine practice: legal considerationsBeth Anne Jackson, Esq.

Practice Management ........ 214What medical practices need to consider when billing for non-physician practitionersDonna J. Kell, BS, MPM

Special Report ................... 216Care Coordination Program introduced at The Children’s InstituteMatthew Masiello, MD, MPH, FAAP

Profile ................................. 218Meet your 2015 president: John P. Williams, MDChristina E. Morton

Editorial ............................... 186Not one mile but 10Deval (Reshma) Paranjpe, MD, FACS

Editorial ............................... 188A brief history of physician paymentBrahma Sharma, MD, FACC

Perspective ......................... 190Considering CTEPH can save livesM. Patricia George, MD

Perspective ......................... 192Raising melanoma awarenessNicole F. Vélez, MD

Perspective ......................... 194Opiates: Now we like them; now we don’tFrank A. Kunkel, MD

Society News ...................... 196• Greater Pittsburgh Diabetes Club• PAGS-WD program announced• HELP conference• Pa. medical students offered low-interest loans• ACMSF offers medical student scholarship

ACMS Alliance News .......... 202

In Memoriam ....................... 202• Casmer Charles Iannuzzi, MD

Classifieds .......................... 222

Reportable Diseases .......... 222

On the coverChicory with Insect

by Charles F. Sturm, MD

Dr. Sturm specializes in family medicine.

2016 Board and Delegate Nominations Form,

Page 221

ACMS ALLIANCEPresident

Kathleen ReshmiFirst Vice President

Patty BarnettSecond Vice President

Joyce Orr Recording Secretary

Justina Purpura Corresponding Secretary

Doris DelseroneTreasurer

Josephine MartinezAssistant Treasurer

Sandra Da Costa

2015 Executive Committee

and Board of Directors

PresidentJohn P. WilliamsPresident-elect

Lawrence R. JohnVice President

David J. DeitrickSecretary

Robert C. CiccoTreasurer

Adele L. TowersBoard Chair

Kevin O. Garrett

DIRECTORS 2015

Vijay K. BahlPatricia L. BononiM. Sabina Daroski

Sharon L. GoldsteinTodd M. Hertzberg

William K. JohnjulioKarl R. Olsen

2016David L. Blinn

Robert W. BragdonThomas B. Campbell

Douglas F. CloughJason J. Lamb

2017Peter G. Ellis

David A. LoganJan W. Madison

Matthew B. StrakaAngela M. Stupi

PEER REVIEW BOARD2015

Paul W. DishartG. Alan Yeasted

2016John G. GuehlRajiv R. Varma

2017Donald B. Middleton

Ralph Schmeltz

PAMED DISTRICT TRUSTEEJohn F. Delaney Jr.

COMMITTEESAwards

Donald B. MiddletonBylaws

David J. DeitrickCommunications

Amelia A. ParéFinance

Karl R. OlsenGala

Patricia BononiAdele L. Towers

Nominating Rajiv R. VarmaPrimary Care

Lawrence R. John

COPYRIGHT 2015: ALLEGHENY COUNTY MEDICAL SOCIETYPOSTMASTER—Send address changes to: Bulletin of the Allegheny County Medical Society, 713 Ridge Avenue, Pittsburgh, PA 15212.

ADMINISTRATIVE STAFFExecutive Director

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EDITORIAL/ADVERTISING OFFICES: Bulletin of the Allegheny County Medical Society, 713 Ridge Avenue, Pittsburgh, PA 15212; (412) 321-5030; fax (412) 321-5323. USPS #072920. PUBLISHER: Allegheny County Medical Society at above address.

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ISSN: 0098-3772Leadership and Advocacy for Patients and Physicians

Affiliated with Pennsylvania Medical Society and American Medical Association

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Bulletin Medical Editor

Deval (Reshma) Paranjpe([email protected])

Associate EditorsMichael Best

([email protected]) Charles Horton, MD

([email protected])Robert H. Howland

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([email protected])Brahma N. Sharma

([email protected])

Managing EditorMeagan K. Welling

([email protected])

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Allegheny County MediCAl SoCiety

ACMS selects vendors for quality and value. Contact our Endorsed Vendors for special pricing.

Leadership and Advocacy for Patients and Physicians

Banking, Financial and Leasing ServicesMedical Banking, Office VISA/MC ServicePNC Bank Brian Wozniak, 412.779.1692 [email protected]

Real Estate ServicesHelen Lynch, Coldwell Banker Your Neighborhood Realtor 412.605.7259 (cell) 412.366.1600, ext. 319 (office) [email protected] Group Insurance ProgramsMedical, Disability, Property and CasualtyUSI AffinityBob Cagna, [email protected]

Professional Liability InsuranceNORCAL MutualLaurie Bush, 800-445-1212, ext. 5558; [email protected]

Medical and Surgical SuppliesAllegheny MedcareMichael Gomber, 412.580.7900 [email protected]

Life InsuranceMalachy Whalen & Co.Malachy Whalen, 412.281.4050 [email protected]

Printing Services and Professional AnnouncementsService for New Associates, Offices and Address ChangesAllegheny County Medical SocietySusan Brown, [email protected]

Auto and Home InsuranceLiberty MutualWalter E. Jackson IV, 412.859.6605, ext. 51907; [email protected]

Member ResourcesBMI Charts, Healthy Lifestyle Posters, Where-to-Turn cardsAllegheny County Medical [email protected]

What does ACMS

membership do for me?

Last week, I thought of an elderly patient whom I followed for nearly a

decade. Blessed with good health for the majority of his life, he was one of those lucky souls who didn’t know what it was like to have a chronic illness of any kind. He vociferously chalked his good health up to clean living, healthy food and regular vigorous exercise. All quite admirable, except for the fact that he went a step further with his declaration. He didn’t understand how people could get chronically ill, because they must have brought it upon themselves. He would disparage diabetics for having no self-control, and hypertensive patients for being lazy, and everyone else for having inferior genetics. He disparaged the medical establishment for spending so much money on the chronically ill. As you can imagine, his opinions and bluster made him a difficult patient to like for many in the office.

And then he returned one day, with a chronic illness. Suddenly, things changed. His focus was no longer on everyone else; it was on himself. “I did everything right,” he said. “This shouldn’t be happening to me. This is not my fault.” He spat out the words angrily, and then launched into a diatribe about how the medical es-tablishment doesn’t spend enough to study his particular illness and doesn’t test everyone for his diagnosis. He complained bitterly that nobody cared about his predicament and that no good treatment options existed.

As tempting as it was to remind

him of his previous statements toward the chronically ill, of course I didn’t. But it made me think. Your situation determines your perspective, and that perspective can become fixed for decades, until something about that situation changes.

If you hurt your leg, and have surgery, and it somehow doesn’t heal well, you can’t walk or exercise well because it hurts. You may have been an average Joe; you may have been a world-class athlete. But you can’t move well. So you gain weight. And can’t lose it, because you can’t move well. And the weight gain may bring on diabe-tes and hypertension. And everything combined may lead to depression, which leads you to not want to exercise or take care of yourself. Heart disease follows. But someone watching in the parking lot as you slowly huff and puff your way to your handicapped spot will only see a fat person who can’t control themselves around junk food.

The root cause was injury, but the world doesn’t see that.

Physicians who experience illness or injury first hand or in their own families often remark afterwards that they identify more with their patients’ needs and frustrations. Breaking your own leg and trying to navigate long

hospital corridors in a cast completely changes your perspective. The movie “The Doctor” (1991), with William Hurt, is a prime example of a physician going through this emotional change. “Regarding Henry” (1991), with Harri-son Ford, concerns an attorney going through the same process.

With the increasingly corporate nature of medicine of late, it isn’t the physicians who need these lessons now so much as the administrators, fly-in consultants and businesspeople. For they are the ones who are deter-mining how many patients employed physicians see in a session and how much time is allotted to each. They are the ones who are involved in issues such as quality of care metrics, length of stay, nursing ratios and others. Let them walk 10 miles in the shoes of the patients who have to deal with illness, fear and worry while dealing with the complexities of the system. And let them walk another 10 miles in the shoes of the physicians who must take care of these patients and the emotion-al toll they undergo in the process. And then let them determine policy. And let our legislators do the same.

It’s all too easy to issue orders and mandates dictating what to do and how to do it and assign blame when the

Editorial

186 Bulletin / May 2015

Not one mile but 10Deval (Reshma) PaRanjPe, mD, FaCs

What a better world it could be if we could just step into each other’s shoes for a day now and then!

187Bulletin / May 2015

1500 One PPG Place 2 Lemoyne Dr., Suite 200 Pittsburgh, PA 15222 Lemoyne, PA 17043 412-566-1212 717-234-4121

Michael A. Cassidy, [email protected]

Our Med Law Blog® is filled with the latest news and information to help you in your medical practice. Visit medlawblog.com to learn more. Med Law Blog® is published by Michael A. Cassidy, Esq., shareholder and chair of Tucker Arensberg’s medical health law practice group.

Our Health Law Practice Group tackles your legal issues and concerns so you can handle the more important work…caring for your patients.

m e d l a w b l o g . c o m

dictates don’t work. It’s the general who spends time with the troops in the trenches who truly understands what challenges are really faced and how to address them successfully. This general also understands how constant shelling and combat fatigue impacts soldiers on a daily basis, and makes adjustments to win the war.

What a better world it could be if we could just step into each other’s shoes for a day now and then! The understanding and compassion that this mental act could bring could cut through prejudice and blame and lead to constructive answers to so many problems – not just in medicine, but in the greater world.

Dr. Paranjpe is an ophthalmologist and medical editor of the ACMS Bulletin. She can be reached at [email protected].

Editorial

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the

Editorial Board, the Bulletin, or the Allegheny County Medical Society.

SAVE THE DATEAllegheny County Medical Society,

cosponsored with Community College of Allegheny County, presents the

2015 Medical Office Occupational Health and

OSHA Update:Wednesday, June 10, 2015

8 a.m. to 10:45 a.m.Visit the ACMS website for

additional information:www.acms.org/OSHA

Physician Category 2 credit for sessions attended. Nursing Continuing Education

hours available.

Editorial


How to pay physicians has been a continual challenge from the

dawn of humanity. Putting a price tag on what physicians do has been a philosophical, ethical and economic dilemma. Physicians have received bracelets in royal courts, bartered poultry and even have been offered cash for their services. From the “just price” of the medieval age to salary and capitation of recent times, there has been continual debate whether a physician should be paid at all or how much should be paid and what should be paid for. Paying a physician in a cost-conscious age has become a Gordian knot.

The oldest debate about medi-cal fees was written on stone in the code of Hammurabi, a Babylonian king 4,000 years ago, and reads, “If a physician has treated a man with a metal knife for a severe wound and has cured the man … then he shall receive ten shekels of silver. …” Greeks even questioned if physicians should be paid at all as medicine was viewed as art rather than skill. Our plight was first recognized by Adam Smith, the first free market economist, when he wrote in his book “Wealth of Nations:”

“We trust our health to the physi-cian; our fortune and sometimes our life and reputation to the lawyer and attorney; such confidence could not be safely reposed in people of a very mean or low condition.”

The idea of a “fee bill” came from the Massachusetts Medical Society in the early 1900s, and physicians charged as they wished. This did not last too long, and hospitals got together (Blue Cross) to survive, soon followed by physicians (Blue Shield) which became the domi-nant health insurance in Pennsylvania. Physicians were allowed to charge “usual customary and reasonable” (UCR) fees. No wonder this model cre-ated discrepancies in charges, yet UCR remained the payment model even after Medicare was established for seniors in 1965. Hardships for seniors worsened due to this variability, which prompted the government to sponsor Harvard Pro-fessor William Hsiao and the American Medical Association (AMA) to conduct a study to estimate relative amount of “work” (units) which included a physi-cian’s own work (physical and mental) + physician’s outlays + liability and pub-lished a relative value scale for 10,000 services called resource-based relative value scale (RBRVS). These services are classified under current procedure terminology (CPT) and protected by AMA as its intellectual property rights. This select group of AMA physicians,

32 (29 specialists + 3 PCPs), called the RUC relative value scale update com-mittee, decides annually the worth of our labor and sweat and sets Medicare fees for our service since 1992.

Therefore, fee for service became our payment method, where a physi-cian is paid a fee for service whether it is an office visit, test or procedure. Critics argue that this payment provides the incentive to order more tests and procedures and created a culture of overutilization. To curb this behavior and reduce cost, managed care models soon emerged from California in the form of health maintenance organi-zations. Unlike traditional indemnity insurance, the idea here was to prepay physicians to cover the health care of customers with restrictions on what can or cannot be ordered. The patient was like an expense to be reduced while the provider was a puppet to be played around with risk on its head. This wave of capitation sounded like “decapitation” when it targeted us in the mid-1990s. Some of us still remember going to town hall meetings. Soon this model became very unpopular with the public and physicians, and the entire

A brief history of physician payment

BRahma shaRma, mD, FaCC

If you are too smart to pay the doctor, you had better be too smart to get ill.

-African Proverb


misadventure died down with some exceptions. Now mutated forms of managed care, so-called accountable care organizations (ACO), are roaring their head with vengeance under the veil of the Affordable Care Act (ACA) with a difference: HMOs limited choice, but ACOs do not. Payment is tied to quality, but liability is shared. It remains to be seen how savings will be shared. Whether there will be any “value” of relative value units in value-based care remains to be seen under these new payment models.

Nowadays, “value-based payment” has become a buzzword ever since Harvard Professor Michael Por-ter wrote his famous book, “Redefining Health Care.” The value was defined as “quality/divided by cost.” The payment will be based on “value” rather than volume. The definition of “value” depends on whom you ask. Who de-termines that value, patient, provider, payer or politicians, is not clear. New health care delivery care models have been designed including episodic payments, bundled pay-ments and global payments under the ACA with question-able savings. Value over volume has become an untested rhetoric, and there has been a rush toward vertical and horizontal integration in the name of the proper alignment of incentives. Integrated models of health care are pop-ping up every day throughout the country that behave like oligopolies or cartels rather than nonprofit organizations.

Physicians mostly have been bystanders in this “tug of war” throughout history but are now “caught in the middle” between patients and payers and have become the “lost tribe” of this age. Most physicians chose this profession as a calling, not for remunerations. We are the only ones in this economic warfare saving lives while others are disrupting. There is no way to assess the value of service by a priest or a soldier or a physician. There are numer-ous value comparisons out there, but there is no payment model for saving a life at 3 a.m. without prior warning if it is you or your family.

Dr. Sharma is associate professor of clinical medicine at the Heart and Vascular Institute at North Hills Passa-vant and can be reached at (412) 748-6484 or [email protected].

Editorial



Ruby Marcocelli

PErsPEctivE


Pulmonary embolism (PE) is a serious problem. According to the

Centers for Disease Control (CDC), the annual incidence of deep venous thrombosis (DVT)/PE is between 300,000 and 600,000 people in the United States alone; 10 to 20 percent of patients die within one month; and at least half of survivors will have long-term sequalae of their disease.

One such chronic problem that greatly limits quality of life and long-term survival is chronic thromboembol-ic pulmonary hypertension (CTEPH). CTEPH is defined as pulmonary arterial hypertension associated in the presence of chronic thromboemboli. Initially believed to be rare, Pengo and colleagues found that 3.8 percent of patients who have suffered PE develop CTEPH within two years, and this has been supported by a more recent study by Held and colleagues. If we use this percentage and a PE incidence of 240,000 based on 80 percent con-ditional survival one month post-PE, conservatively at least 9,000 patients would develop CTEPH each year. Yet not even 1/10 of these undergo curative treatment of pulmonary throm-boendartarectomy each year. Also of note, approximately 2/3 of patients who have CTEPH have no known history of acute PE (Lang, 2004). When taken to-gether, the prevalence of CTEPH is not insignificant, is likely grossly underdi-agnosed and certainly undertreated.

Untreated CTEPH limits survival, and higher pulmonary artery pressures have been associated with increased death. Without treatment, patients with a mean pulmonary artery pressure

greater than 40mmHg at the time of diagnosis had a 70 percent mortality in eight to 10 years (Riedel et al, 1982).

In this era of advanced therapeutics for pulmonary arterial hypertension, we now have several options avail-able to patients with CTEPH. The first and treatment of choice is the only potentially curable treatment for PAH short of lung transplant: pulmonary thromboendartarectomy. All patients with CTEPH should be considered for this surgical cure. For patients in whom the disease is not amenable to sur-gery (a decision that should be made by a CTEPH surgeon), or in whom surgery is not an option otherwise, we also have medical therapies that are available for treatment. Hence, making this diagnosis provides a crucial step in improving survival and improving lives of our patients.

What are the most essential steps in making a proper diagnosis? The first is maintaining a high index of suspicion. In patients who have persistent dyspnea on exertion post-PE, or who complain of being “out of shape” after their PE, we must at least consider CTEPH on the differential. In addition, we need to consider this as part of our routine work up for new pulmonary arterial hyperten-sion as well. Although CT angiogram has replaced ventilation/perfusion (V/Q) scans in the evaluation of acute PE,

the screening test of choice for CTEPH remains ventilation/perfusion scan. While sensitive in detecting very prox-imal disease, Tunariu and colleagues showed that V/Q scanning is more sensitive than CT angiogram in detect-ing PE, likely due to missing diffuse distal disease. Echocardiogram also is a useful screening test for pulmonary hypertension, though again a high index of suspicion mandates careful interpretation of echo findings and even consideration of exercise-induced PH in the presence of normal echo findings. Due to the complex decision making with regard to medical or surgical treat-ment of CTEPH, it is recommended that all patients in whom CTEPH is suspect-ed be referred to a CTEPH specialty center for further evaluation.

In recent years, there has been a huge surge in technology development that is expanding our treatment op-tions for PE. In addition to heparin and warfarin, we now have catheter-based lytic techniques and novel oral antico-agulants, and these new techniques

Considering CTEPH can save livesm. PatRiCia GeoRGe, mD

What are the most essential steps in making a proper diagnosis? The first is maintaining a high index of suspicion. In patients who have persistent dyspnea on exertion post-PE, or who complain of being “out of shape” after their PE, we must at least consider CTEPH on the differential.


motivate us to develop rational protocols for their imple-mentation. Early trials have provided equipoise for con-tinued investigations in the appropriate populations, and we are all eager to see if early aggressive lytic treatment will impact these long-term outcomes. In the meantime, it is crucial that we maintain vigilance in monitoring our patients post-PE for complete resolution of symptoms. Investigating dyspnea in those who have an incomplete response and referral to a CTEPH/pulmonary hyperten-sion center when indicated may indeed save lives.

Dr. George is assistant professor of medicine, Com-prehensive Pulmonary Hypertension Program, UPMC. She can be reached at [email protected].

PErsPEctivE



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PErsPEctivE


Melanoma is increasing at a faster rate than any other preventable

cancer in the United States. Between 1950 and 2007, the incidence rose 17-fold in men (1.9 to 33.5 per 100,000) and more than 9-fold in women (2.6 to 25.3 per 100,000).1 This year, 73,870 new cases are projected in the United States and 9,940 deaths, or approx-imately one death each hour. 2 Mela-noma is the leading cause of cancer death in women ages 25 to 30 and is second only to breast cancer in women ages 30 to 34 years.

Some have attributed rising rates to earlier diagnosis, but melanoma incidence is rising among all categories of tumor depth and subtypes, and not merely an artifact of more intensive screening or identification of thin tumors. 3 Why, then, are the rates of other cancers falling while melanoma continues to rise?

UV exposure, both from sunlight and tanning beds, certainly plays a role. Although challenging to quantify lifetime UV exposure, UVB flux (a mea-sure of midrange UV radiation) and time outdoors significantly increases risk of melanoma.4 Rising UV indices in the setting of a depleting ozone layer also directly correlate with higher rates of melanoma. 5 Contrary to the myth that a tan is “protective,” even among women with the ability to develop a deep tan, a 10 percent increase in time outdoors was associated with a 5.8 percent increase in odds of melano-ma.4

In a landmark study, the Interna-tional Agency for Research on Cancer (IARC) found that first exposure to

tanning beds before the age of 35 increases an individual’s lifetime risk of melanoma by as much as 75 per-cent.6 Since then, other studies have echoed these findings and shown that melanoma risk increases with length and duration of exposure to tanning regardless of device used (UVB or UVA devices). A systematic review on the prevalence of tanning found that 35.7 percent of adults, 55 percent of univer-sity students and 19.3 percent of ado-lescents had “ever” used tanning beds. The study estimated that tanning beds accounted for more skin cancers in the United States, Europe and Australia than the number of lung cancer cases caused by smoking in these areas.7

Yet despite this data, up to 1 million Americans visit tanning salons each day; 70 percent of these are Caucasian females ages 16-29 years. 8 Amongst the top 125 universities, 48 percent have indoor tanning facilities either on campus or in off-campus housing and up to 14 percent allow campus cash cards to be used to pay for tanning, including some local universities. 9

Whereas the anti-tobacco campaign has been gaining momentum for years, public health has just recently turned its attention to this issue. On May 29, 2014, the Food and Drug Adminis-tration (FDA) reclassified sunlamp products as a class II (moderate risk)

device requiring a black box warning. Two months later, the Surgeon General issued a “Call to Action to Prevent Skin Cancer.” 8 In Pennsylvania, tanning laws, restricting the use of tanning beds in minors under the age of 17, went into effect in July 2014.

The incidence of melanoma may not stabilize anytime soon, but, if identified early, thin melanomas have an excel-lent prognosis. However, early detec-tion guidelines have not been clearly defined. The American Cancer Society (ACS) recommends that primary care physicians (PCPs) check for skin cancer “on the occasion of a periodic health examination.” The American Academy of Dermatology (AAD) rec-ommends self-skin exams but does not identify when or how often physician exams should be performed. As of their last review in 2009, the U.S. Preventive Services Task Force (USPSTF), stated there was “insufficient evidence” for a total body skin exam by either a clini-cian or patient. 1 Nevertheless, stud-ies do show that physician-detected melanomas are thinner. In Germany, a yearlong statewide screening program was associated with a nearly 50 per-cent reduction in melanoma mortality.10 Findings such as these may prompt changes in the USPSTF guidelines.

Access to physicians trained in skin cancer surveillance is another chal-lenge. Dermatology training in medical school is limited, and dermatology training programs graduate few resi-dents each year. Tightened provider networks also risk reducing access to specialists. Fast-track referral systems between primary care and dermatology

Raising melanoma awarenessniCole F. vÉlez, mD

PErsPEctivE


do significantly increase early melano-ma diagnosis. 11

A culture shift is certainly in the works. You are more likely to see kids in sun-protective shirts and lathered in sunscreen at the pool these days. Self-tanning creams and spray tans are becoming more popular alternatives. The NFL and MLB are examples of organizations that have partnered with the AAD to support skin cancer screen-ings in the community. Dermatologists across the country offered free skin cancer screenings on May 4 in honor of Melanoma Monday and throughout the month. Yet more needs to be done.

The dermatology community must continue to promote education about melanoma, and the importance of

screening in high-risk populations (i.e., patients with a family history of melanoma, red hair, tanning history, immunosuppression or a high num-ber of nevi). Dermatology also must facilitate access for patients with new or changing skin lesions. As physi-cians, we should all feel comfortable asking our patients about risk factors for melanoma. Just as our electronic medical systems prompt us to counsel our patients who smoke, we should be prompted to counsel our patients who sunburn or tan frequently. As commu-nity leaders, we can help to change the tanning culture and dispel the myth of a “healthy” tan. Our patients too will play an important role in spreading the word. The success of the breast and

lung cancer campaigns has been in large part due to the patient advocacy groups. Improving prevention and early detection could have a significant impact on melanoma.

Dr. Vélez is a dermatologist and Mohs surgeon with Westmoreland Dermatology Associates and on staff at the University of Pittsburgh Medical Center, East. She can be reached at [email protected].

The opinion expressed in this column is that of the writer and does not

necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

References1. Mayer JE, Swetter SM, Fu T, Geller

AC. Screening, early detection, education, and trends for melanoma: current status (2007-2013) and future directions: Part I & II. Epidemiology, high-risk groups, clinical strategies, and diagnostic technology. J Am Acad Dermatol 2014 Oct;71(4):599-611.

2. American Cancer Society. Cancer Facts & Figures 2015. http://www.cancer.org/acs/groups/content/@edit044552.pdf. Accessed March 19, 2015

3. Lee KC, Weinstock MA. Melanoma is up: are we up to this challenge? J Invest Dermatol 2009 Jul;129(7):1604-6.

4. Fears TR, Bird CC, Guerry D 4th, et. al. Average midrange ultraviolet radiation flux and time outdoors predict melanoma risk. Cancer Res 2002 Jul 15;62(14):3992-6.

5. Salmon PJ, Chan WC, Griffin J, McKenzie R, Rademaker M. Extremely high levels of melanoma in Tauranga, New Zea-land: possible causes and comparisons with Australia and the northern hemisphere. Aus-tralas J Dermatol 2007 Nov;48(4):208:16.

6. International Agency for Research on Cancer Working Group. The association of use of sunbeds with cutaneous malig-nant melanoma and other skin cancers: A systemiatic review. Int J Cancer 2007

Mar;120(5):116-22.7. Wehner MR, Chren MM, Nameth D,

Choudhry A, Gaskins M, Nead KT, Boscar-din WJ, Linos E. International prevalence of indoor tanning: a systematic review and meta-analysis. JAMA Dermatol 2014 Apr;150(4):390-400.

8. Ernst A, Grimm A, Lim HW. Tanning lamps: Health effects and reclassification by the Food and Drug Administration. J Am Acad Dermatol 2015;72:175-80.

9. Pagoto SL, Lemon SC, Oleski JL, Scully JM, Olendzki GF, Evans MM, Li W, Florence LC, Kirkland B, Hillhouse JJ. Availability of tanning beds on US college campuses. JAMA Dermatol 2015 Jan;151(1):59-63.

10. Breitbart EW, Waldmann A, Nolte S, Capellaro M, Greinert R, Volkmer B, Katalinic A. Systemiatic skin cancer screening in Northern Germany. J Am Acad Dermatol 2012 Feb;66(2):201-11.

11. Moreno-Ramirez D, Ojeda-Vila T, Ri-os-Martin JJ, Ruiz-Villaverde R, de-Troya M, Sanz-Trelles A, et al. The role of accessibility policies and other determinants of health care provision in the initial prognosis of ma-lignant melanoma: A cross-sectional study. J Am Acad Dermatol 2014 Sep;71(3):507-15.

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Regulations regarding opioids often present like a baseball bat to the

head: a hard blow, with little discrimina-tion, but often with profound effects. In the 1970 and 80s, the use of opioids to treat pain began to increase in popularity. By the 90s, physicians were strongly encouraged to aggressively treat pain – all pain – including chronic, noncancerous pain, with opioid med-ications. The Joint Commission on Accreditation of Health Care (JCAHO) made the patient’s pain score a fifth vital sign in 2000. Pharmaceutical com-panies pointed to this JCAHO doctrine, and with only a few poorly controlled studies that noted low addiction risk in patients being prescribed opioids for chronic nonmalignant pain. The rest is history.

Oxycontin quickly became the drug of choice among those with opioid ad-diction due to the ability to crush it and snort it. In so doing, a large percent-age of the oxycodone meant for slow release was absorbed quickly when snorted or injected. In fact, at one point in time, oxycodone prescribed in Florida accounted for more than 90 percent of the medication prescribed for the entire United States. A docu-mentary called the Oxycontin Express described the round trips from the Greater Pittsburgh International Airport to Florida and back in the same day.

How did this happen? The enthu-

siasm for treating patients with opi-oids was not balanced with teaching prescribers about addiction risk. In fact, many physicians worried about litiga-tion against them for not aggressively prescribing pain meds to patients com-plaining of chronic pain. Too often, we relied on the belief that “good patients don’t get addicted to opioids.” Then came the escalation in opioid-related overdose deaths and subsequently, the war on opioids. Many still do not realize the simple basics of opioid prescribing, addiction recognition and treatment. Education in safe opioid prescribing is lacking or nonexistent in many training programs.

Our addiction services company has a one-day course called Drug School for those who want to learn the basics of safe opioid prescribing plus recognition and treatment of addiction. We’re seeing more and more young physicians and extenders emerging from training with a simple thought regarding opioids: Just don’t prescribe them. What is needed is education of all those who possess the ability to prescribe opioids on the basics of appropriate prescribing. Knowing the important risk factors that give pa-tients an increased risk for addiction is essential.

The strongest risk factors are simple to learn: a family history of substance use disorder (drugs or alcohol); a personal history of substance abuse; and significant psychological ills. Great care should be exercised in prescribing opioids to patients with any of these risk factors. Other factors, such as young age, complaints or pain greater than what is medically expected, the just-run-out-of-pills stories, we are all familiar with. One of the biggest reasons patients and physicians fail in treating chronic pain is lack of under-standing pain relief goals. Patients must be instructed that often our goals with chronic pain management are expectations of a 35 percent decrease in rest pain. Generally, understanding that pain medications are NOT useful in activity pain must be pointed out to patients with chronic pain syndromes. Practitioners must explain to their patients these reasonable expectations of pain relief along with understanding risks, and factors such as tolerance, physical dependence, side effects and addiction risk. Those who choose to cautiously prescribe opioids for chronic nonmalignant pain must do so with appropriate protocols in place, in order to protect their patients as well as themselves.

Many of the methods used also can aid us in prescribing to those we feel are at risk for developing problems with

Opiates: Now we like them; now we don’t

FRank a. kunkel, mD

PErsPEctivE


opioids. Enlisting the help of a loved one is encouraged. So often, it’s the “better half” who makes sure a patient takes their heart medications; give them one more responsibility: the pain pills. The one rule I have a zero nego-tiation with is: You may never take to-morrow’s pain meds today, never.

Toxicology testing has become mainstream. Practicing without testing in the pain and addiction population is unwise. I am a huge proponent of oral fluid testing, primarily because it is witnessed. If practices use urine drug testing, it must be random to avoid substitution issues.

Recently, I finished a Drug School lecture to two physicians in residency training and one medical student, with a recipe to create addiction: Take a young person with a family history of substance abuse and expose them to high-dose, short-acting opioids. Then the first patient presented: a 21-year-old with a strong family history of substance use disorder. The patient stated that he had a dental extraction and was prescribed Oxycodone 30mg tablets, #180. The patient then stated that this was the beginning of his drug addiction.

The use of buprenorphine for

medically assisted treatment (MAT) of opioid addiction must be used hand-in-hand with cognitive therapy. While buprenorphine for the treatment of addiction has added a good tool to our tool chest of treatment means, this medication, like all opioid medications, has a potential for abuse. Actually, current figures have buprenorphine on the street a very close second behind oxycodone products abused. Not all taking buprenorphine on the street are taking it solely because they cannot get a compassionate provider; many take it simply to bridge between opioids taken recently to avoid withdrawal syndrome. We have unwittingly made this medica-tion a commodity on the street. In our Philadelphia office, buprenorphine on the street is cheaper than can be pur-chased directly from a pharmacy with a prescription. Think about that: $2.50 for a gallon of milk at the grocery store, the same gallon of milk sold outside for $ 1.50 … hard to believe.

Finally, a word about Narcan. Often, physicians fear that prescribing Nar-can to their patients may make them seem irresponsible. This is simply not the case. We all need to put bias, stigma and worries aside and prescribe more Narcan for overdose rescue. All

patients in MAT for opioid addiction (Methadone and buprenorphine clinics) as well as pain patients on significant doses of opioids, and especially those with co-morbid conditions, should be educated on the use of and be pre-scribed Narcan for overdose rescue.

So, the Good, the Bad, and the Ugly. The Good: We have some good meds to treat pain and to be used in addiction treatment. The Bad: Pain pills can certainly lead to addiction and overdose deaths. The Ugly? The bias and stigma against the addiction pa-tient is stronger than ever. A wise man once told me, “Frank, I have treated thousands of addiction patients and yet have met one that woke in the morning one day and thought, ‘Ah, today my goal is to get addicted to narcotics.’” It happens; they remain our patients.

Dr. Kunkel is medical director of Accessible Recovery Services Inc., based in Pittsburgh, ARSSuboxone.com, and can be reached at [email protected].

The opinion expressed in this column is that of the writer and does not

necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

Writers WantedParticipate in our new columns!

Interesting Cases and What Are You Reading? For more information, contact Bulletin Managing Editor

Meagan Welling, (412) 321-5030, ext. 105, or [email protected].


sociEty NEws

Greater Pittsburgh Diabetes Club to meet at ACMS

The newly reorganized Greater Pittsburgh Diabetes Club (GPDC) will host a meeting on Thursday, June 25, at the Allegheny County Medical Soci-ety, 713 Ridge Avenue, North Shore, Pittsburgh, 15212.

The dinner meeting is open to any-one whose primary care and concern is those with diabetes. Doors will open at 6 p.m. to provide an opportunity for networking with vendors and other practitioners in the area.

Amy Rothberg, MD, assistant professor of Internal Medicine at the University of Michigan, will be the guest speaker. Dr. Rothberg attended Wayne State University Medical School, where she received academic honors that included the Upjohn Award for Excel-lence in Endocrinology and Metabo-lism. She served both her internship and residency at the University of Michigan (Ann Arbor) Medical Center’s Department of Internal Medicine. Dr. Rothberg then completed a fellowship program in the MEND Division at the University of Michigan Health System in Ann Arbor and joined the MEND staff following.

The topic of Dr. Rothberg’s presen-tation will be “Evaluation and Treatment of Obesity in the Endocrine Practice.”

If you wish to learn more about the GPDC, contact any of the officers: Jennifer Holtz, MD; Rose Salata, MD; or Jann Johnston, MD; or board mem-bers: Michael Korczynski, PharmD, BCACP, CDE; Mary Korytkowski, MD; Janis McWilliams, RN, MSN, CDE, BC-ADM; Deborah Rotenstein, MD; or Linda Seminario, RN, PhD, CDE.

For more information, contact Dianne Meister at (412) 321-5030 or [email protected].

PAGS-WD program announcedThe Pennsylvania Geriatrics Society

– Western Division (PAGS-WD) is pleased to present Controversies in Geriatric Medicine. This new program is designed to complement the existing suite of exceptional educational offer-ings sponsored by the Society.

The program begins with a complex case, followed by comments from an expert panel. Audience participation is encouraged with appropriate time allotted for general discussion. The program is scheduled for Thursday, June 11, at the Herberman Confer-ence Center, beginning at 6 p.m. with registration and networking, followed by dinner and case presentation to commence at 6:45 p.m.

The featured case for the evening, Abdominal Aortic Aneurysm, will be presented by Daphne Bicket, MD, MLS, director of Geriatrics, UPMC McKeesport Family Residency; clinical assistant professor of Family Medicine in the School of Medicine, University of Pittsburgh. Dr. Bicket will address the management issues of navigat-ing a complex case of a pleasant but demented 81-year-old who has a 5.5 AAA, CKD and a 99 percent carotid artery stenosis. Discussion includes risk assessment and benefit, and how to help the family decide.

Fred Rubin, MD, professor of med-icine, University of Pittsburgh School of Medicine; chief of Medicine, UPMC Shadyside, will serve as moderator. Dr. Rubin will present a framework for pre-op evaluation of the patient, which could apply to all patients. Panel for the evening include:

• Michael Singh, MD, associate professor of surgery, chief of Vascular Surgery, UPMC Shadyside; director of the Aortic Center UPMC HVI. Dr. Singh

will discuss surgical indications and risk of both AAA repair and of asymp-tomatic carotid artery repair.

• Jane Schell, MD, MHS, assistant professor of medicine, Division of Nephrology and Section of Palliative Care and Medical Ethics, University of Pittsburgh, will discuss the risks of administering IV contrast with chronic kidney disease. Dr. Schell also will dis-cuss helping patients and family clarify their goals and values.

The program is complimentary for members of the Society, but registra-tion is required. Non-members are welcome at a nominal fee of $35. Registration is being accepted online at http://june2015pags.eventbrite.com.

The society is a regional affiliate of the American Geriatrics Society and is dedicated to promoting geriatric education to all health care profession-als interested in improving the health and well-being of all older persons. To inquire about becoming a member or program details, please contact Nadine Popovich at [email protected] or (412) 321-5030 or visit the society website at www.pagswd.org.

HELP conference heldThe 13th annual National Hospital

Elder Life Program (HELP) confer-ence was held in conjunction with the Clinical Update conference on March 26-27, 2015. This two-day international conference educated HELP teams with strategies for delirium prevention, and insights to learn to use HELP as a way to improve hospital-wide care of the el-derly, and creating a climate of change.

Expert clinicians and seasoned members of the HELP sites shared evidence-based information and their clinical insights on selected topics re-garding the influence of HELP, delirium


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Practice Opportunities in Pennsylvania at www.POPonline.org

connects Physicians, Physician Assistants & Nurse Practitioners with Pennsylvania healthcare employers.

Private practice memberships

begin at $500.

POP is a part of Medical Opportunities serving the Great Lakes Region since 1994.

Recruiting is hard work.

We can help. updates and the larger policy implications of care for the

elderly. More than 65 registrants from various states were on-hand including international participants from Canada.

Serving as course directors were Fred Rubin, MD; chair, Department of Medicine, UPMC Shadyside; profes-sor of medicine, University of Pittsburgh School of Medi-cine; and president of the Pennsylvania Geriatrics Society – Western Division (PAGS-WD); and Sharon Inouye, MD, MPH, professor of medicine, Beth Israel Deaconess Med-ical Center, Harvard Medical School; Milton and Shirley F. Levy Family Chair; director, Aging Brain Center, Institute for Aging Research, Hebrew SeniorLife; and Shin-Yi Lao, MPH, BSN, RN, program coordinator for HELP and CEDARTREE at Hebrew SeniorLife.

This innovative model program, designed by Dr. In-ouye, improves the hospital experience for older patients by helping them maintain their cognitive and functional abilities; maximizing independence at discharge; assisting with the transition to the home; and preventing unplanned readmission.

Continued on Page 198


sociEty NEws

Through HELP, the hospital be-comes a place where older patients can feel secure as they participate in their course of treatment and maintain some control over their own recupera-tion. Hospitals around the world have implemented the program, and HELP has received extensive coverage in medical journals and mainstream me-dia. For more information on HELP and delirium, or to learn how to become a HELP site, visit www.hospitalelderlife-program.com.

Pa. medical students offered low-interest loans

The Foundation of the Pennsylvania Medical Society is accepting applica-tions from students attending Lake Erie College of Osteopathic Medicine. Addi-tionally, the student must be a Penn-sylvania resident for at least 12 months prior to attending medical school and not for the sole purpose of obtaining an undergraduate degree. Below are highlights of the program.

• No application or origination fees.• Individual loan awards up to

$7,000.• No payments required during

school or graduate training (i.e., intern-ship, residency, or fellowship training).

• Deferment up to five years for graduate training.

• Interest rate will not exceed 6 per-cent during school or graduate training.

• School and deferment interest rate is 91-day, T-Bill note plus a margin based upon the first academic year that loan funds were obtained.

– First loan award obtained prior to July 1, 2013: the margin is 2.0 percent.

– First loan award obtained on or after July 1, 2013: the margin is 3.5 percent.

• May choose monthly installments following graduate training by signing a new promissory note for an Amortizing Loan.

• Amortizing Loan Note term is up to 10 years with a fixed interest rate.

The application should be sent directly to the Foundation’s office by June 1, 2015.

To apply, download the appropri-ate application from the website and submit it according to the submission

instructions. For an application, contact the Foundation at (717) 558-7852 or visit Student Financial Services. Also, please check out information about medical education scholarships.

ACMS Foundation offers medical student scholarship

The Allegheny County Medical Society Foundation is offering a $4,000

From Page 197


Photo Provided

Attendees of the 13th Annual HELP conference are flanked by course direc-tors Shin-Yi Lao, MPH, BSN, RN, and Sharon Inouye, MD, MPH. Fred Rubin, MD, also served as course director.


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scholarship to a qualified medical student. Applications will be accepted from July 1 to September 30, 2015.

Eligibility for scholarship applicants: • Applicant must be a Pennsylvania resident from Allegh-

eny County.• Applicant must be a Pennsylvania resident for at least

12 months prior to registering as a medical student. • Applicant must be enrolled full time in a fully accredited

Pennsylvania medical school. • Applicant must be enrolled or entering his/her 3rd or 4th

year of medical school. Applicant must submit: • A completed scholarship application form. • Two reference letters, from persons other than family

members, documenting the applicant’s integrity, inter-personal skills, and potential as a future physician. Note: One reference letter must be from either a medical school

professor or a physician. • A letter, on school letterhead, from the applicant’s medi-

cal school verifying that he/she is enrolled full time as a third or fourth-year medical student at that institution.

• A typed one-page essay addressing the following: How do you hope to be involved in your community beyond clinical care of patients? In what ways would you hope to demonstrate leadership as a physician in your community?

Application materials must be postmarked by Septem-ber 30, 2015. Applicants will be notified of the committee’s decision in December 2015. Students can download an application and review eligibility requirements at http://www.foundationpamedsoc.org/SFS/Scholarships/Allegheny.aspx.

Application materials should be mailed to: ACMS Schol-arship, c/o The Foundation, 777 East Park Drive, P.O. Box 8820, Harrisburg, PA 17105-8820. For more information, call (717) 558-7852 or (717) 558-7854, Fax: (717) 558-7818, or email: [email protected]. The website is www.foundationpamedsoc.org.

From Page 198


alliaNcE NEws

Calendar Tue., June 23 Wrap-Up and Kick-Off 2015-16 (Woodlands at Longwood – Rose K. Roarty)

Tue., Sept. 8 Governing Board Meeting (ACMS)

Tue., Sept. 22 Autumn General Meeting (Leadership and Venue TBD)

Tue., Oct. 13 Governing Board Meeting (ACMS)

Sat./Sun., Oct. 23-25 PMSA Confluence (Hershey Lodge and Convention Center – ACMSA Reps and Gifting)

Tue., Nov. 10 Governing Board Meeting (ACMS)

Sun., Dec. 6 General Meeting II, Holiday Brunch/ Hanukah Thompson Award (Leadership and Venue TBD)

Sun., Nov. 29 +- Event Pending (Leadership and Venue TBD) Leap Year Feb. 29, 2016

Leadership Report for ACMS Alliance Year 2015-16

The Annual (General) Meeting and Luncheon will be held May 19, 2015, at Pittsburgh Golf Club, Schenley Park. Governing Board proposed for ACMSA 2015-16 – recommendations from the floor are encouraged and welcome.

Election/Appointment of Officers and Confirmation of Governing Board by the General Membership will take place at the of Annual (General) Meet-ing and Luncheon.

CHAIRTBD

ALTERNATE CHAIR PATTY BARNETT

TREASURER SANDRA DACOSTA

ASSISTANT TREASURER(S) LIZ BLUME AND BARBARA WIBLE

RECORDING SECRETARY/AGENDAJUSTINA PURPURA

CORRESPONDING SECRETARY AND MED. BENEVOLENCE

DORIS DELSERONE ADVISER ACMS JOHN G. KRAH

ADVISER ACMSAROSE KUNKEL ROARTY

ADVISER ACMSAKATHLEEN JENNINGS RESHMI

PARLIAMENTARIANBARBARA WIBLE

PMSA ELECTED DELEGATESTBD

ELENA CERRI, MICHEL FRANKLIN, PATTI HETRICK, WILLIAM HETRICK, MD,

ROSE KUTSENKOW, MARILYN LAKDWALA, SUZANNE LEEHAN, LOIS LEVY, JO MARTINEZ, NESSA MINES,

GERALDINE ORR, JOYCE ORR, IRENE PAYAN AND YOKO SANDO

HAVE AGREED TO SERVE ON VARIOUS STANDING COMMITTEES AND/OR WORK

ON PROJECTS AND EVENTS.

ACMSA’S GOVERNING BOARD LEADERSHIP REPORT SINCE JANUARY 10, 2012, REPLACES THE NOMINATING COMMITTEE REPORT.

Wrap-Up and Kick-Off Meeting ACMS Alliance Year 2015-16

ACMSA Members and those interested in membership are most welcome to attend the Wrap-Up and Kick-Off Meeting at 10:30 a.m. Tues-day, June 23, 2015, at Longwood Resi-dences in Oakmont, hosted by ACMSA Adviser Rose Kunkle Roarty. RSVP to Rose Roarty, ACMSA Directory Listing, by June 16. Non-members, call (412) 321-5030 for more information.

Rose will provide the meeting room and snacks, and attendees can stay for modest cost Dutch treat lunch at the WOODLANDS GRILL!

Content anD text By kathleen jenninGs Reshmi

iN MEMoriaM

Casmer Charles Iannuzzi, MD, 95, of Mt. Leba-non, died March 7, 2015.

Dr. Iannuzzi graduated in medicine from the Cath-olic University of Louvain, Belgium, and served his internship at Youngstown Hospital, Ohio.

He was a veteran of World War II, using his military benefits to earn a bachelor of pharmacy degree from the University of Pittsburgh in 1948.

Dr. Iannuzzi specialized in family medicine and emergency medicine, starting his career at the UMWA Centerville Clinic, where he met his second wife, Doro-thy Crnkovich Iannuzzi, who survives.

Also surviving are a daughter, Susan (Emeil She-nouda) Iannuzzi; a granddaughter, Mira Shenouda; a daughter, Dr. Phyllis Iannuzzi (with his late wife, Lisa Lutz Iannuzzi); and many nieces and nephews.

Services were held March 14 in Good Shepherd Roman Catholic Church, Braddock.


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MatEria MEdica

Diabetes mellitus is a major health challenge in the United States

and worldwide. In the United States, there are an estimated 25.8 million patients (diagnosed and undiagnosed) with diabetes.1 All patients with type 1 diabetes (DM1) and many patients with type 2 diabetes (DM2) require insulin therapy at some point to adequately manage their disease. Based on 2012 data, there were 3.1 million diabetics in the United States using insulin with or without other diabetes therapies.2 On July 27, 2014, the Food and Drug Administration (FDA) approved tech-nosphere insulin (Afrezza®), a novel inhaled insulin product, making it the only non-injectable insulin product that is currently available. This deliv-ery option could prove advantageous for diabetics who are apprehensive about initiating or intensifying insulin therapy via injections. This is actually the second inhaled insulin product approved by the FDA. The first inhaled insulin, Exubera®, approved by the FDA in January 2006, was withdrawn from the market by the manufacturer within two years after its approval due to low patient and provider acceptance and profit margins not meeting expec-tations.2

What it is: Inhaled technosphere insulin (Afrezza®) is a drug-device combination product consisting of a

dry powder formulation of recombi-nant regular human insulin (techno-sphere insulin) and an inhaler device (Gen2 inhaler).2,3 The Gen2 inhaler is breath-powered by the patient.3 When the patient inhales through the device, the powder is aerosolized and deliv-ered to the lung. Inhaled technosphere insulin is intended to cover prandial insulin requirements for the treatment of patients with both DM1 and DM2.

How it works:2,3,4 Technosphere insulin (TI) is a dry powder of human (recombinant DNA) insulin formulated to absorb onto technosphere micropar-ticles for pulmonary administration. The powder dissolves immediately on inha-lation to deliver insulin quickly, reaching peak concentrations within about 15 minutes of administration.2 The carrier of these insulin particles is an inert excipient that encapsulates peptides and proteins into microspheres. These particles dissolve in the neutral pH environment of the lungs, with the small size facilitating efficient distribu-tion and absorption into the circulation. Once the insulin enters the circulation, metabolism and elimination are similar to that of regular human insulin. The excipient is absorbed into the blood-stream and is excreted intact primarily through the kidneys. TI’s kinetics make it the fastest absorbed of any insulin available, although its overall onset of action appears similar to insulin lispro. Its glucose-lowering properties are less than that of rapid-acting insulins, but it does demonstrate less hypoglycemia.2

Indications:3 Afrezza® is a rap-id-acting inhaled insulin indicated to improve glycemic control in adult pa-tients with type 1 and type 2 diabetes mellitus. It represents an alternative to prandial subcutaneous bolus injections and will likely be used concomitantly with injected basal insulin.

Dosage:3 Initial dose:• Insulin naïve patients: –Start with 4 units of inhaled TI with

each meal • Patients previously on subcutane-

ous (SC) prandial insulin:–Determine the appropriate inhaled

insulin dose for each meal by convert-ing from the SC injected dose; the cur-rent injected dose should be rounded up to the nearest multiple of 4 to arrive at the equivalent inhaled TI dose. For example, 4, 6, and 9 units would be converted to 4, 8, and 12 units of TI (see Figure 1, page 206).

• Patients previously on subcutane-ous premixed insulin:

–Estimate the prandial injected dose by dividing half of the total daily injected premixed insulin dose equally among the three meals of the day. Convert each estimated injected prandial dose to a prandial inhaled dose based upon Figure 1. In addition, administer half of the total daily inject-ed premixed dose as an injected basal insulin dose.

For inhaled TI doses exceeding 8 units, inhalations from multiple car-tridges are necessary. To achieve the

Technosphere insulin (Afrezza®): a new, inhaled prandial insulin

tuCkeR FReeDy, PhaRmD, BCPs



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MatEria MEdica

required total prandial dose, patients would use a combination of 4 unit and 8 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown. For doses above 24 units, combinations of different multiple cartridges may be used.

How supplied:3 Inhaled techno-sphere insulin is available as 4 unit and 8 unit single-use cartridges. The car-tridges are color-coded, blue for 4 units and green for 8 units. Each cartridge is marked with “afrezza” and “4 units” or “8 units.”

The Gen2 inhaler is a small por-table inhaler, approximately the size of a whistle. It is fully assembled with a removable mouthpiece cover. The disposable inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.3

Adverse effects:2,3,4,5 The most common adverse effects of TI have been throat pain or irritation, cough, and hypoglycemia. Cough occurred in ~27 percent of patients who received TI and was the most common reason for discontinuing the drug. Cough usually occurred within 10 minutes, was gener-ally mild, dry, intermittent or single-de-fined, and tended to decrease over time.4 In patients with DM2, severe and non-severe hypoglycemia were more common in patients who took TI (5.1 percent and 67 percent) compared to those who took placebo (1.7 percent and 30 percent).3 TI will have a boxed warning advising that acute broncho-spasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). A greater decline in forced expiratory volume in 1 second (FEV1) with TI therapy

versus comparator was noted during the first three months of therapy.3 The treatment differences were small (on average about 40mL), and the results from two-year studies show that the early difference persisted, but did not appear to progress over the two-year period. Patients using TI should be assessed with spirometry at baseline, after the initial six months of therapy and annually thereafter even in the ab-sence of pulmonary symptoms.4 More frequent lung function assessment should be considered in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or cough.3 Controlled pulmonary safety data beyond two years of treatment are not available.4 In clinical trials with TI, two cases of lung cancer were reported in patients exposed to TI while no cases were reported for the com-parators. Two additional cases of lung cancer (squamous cell) were reported in non-smokers exposed to TI after the trial completion. In clinical trials enrolling subjects with type 1 diabe-tes, diabetic ketoacidosis (DKA) was more common in subjects receiving inhaled TI (0.43 percent; n=13) than in

subjects receiving comparators (0.14 percent; n=3).3 Weight gain may occur with some insulin therapies, including inhaled TI. In a clinical trial of patients with DM2, there was a mean 0.49 kg weight gain among inhaled TI-treated patients compared with a mean 1.13 kg weight loss among placebo-treated patients.3

Drug interactions:3 No studies have been published on drug interac-tions with inhaled TI; therefore, con-current medications that can interfere with glucose utilization should be the primary focus of a medication regimen review before initiating therapy with inhaled insulin. Use caution when combining TI with any of these agents. Increase the frequency of blood glu-cose monitoring and adjust the TI dose as necessary.

Contraindications:3 Inhaled TI is contraindicated in patients with chron-ic lung disease, such as asthma or COPD, because of the risk of acute bronchospasm, during episodes of hypoglycemia, and in patients with hy-persensitivity to regular human insulin or any of the inhaled TI excipients. Use is not recommended in smokers

From Page 204 Figure 13


MatEria MEdica

or patients who have recently stopped smoking based on limited data regard-ing its safety and efficacy.3

Warnings:3 Acute bronchospasm has been observed following inhaled TI dosing in patients with asthma and patients with COPD. The long-term safety and efficacy of TI in patients with chronic lung disease has not been established. Inhaled TI carries a “Boxed Warning” regarding the risk of acute bronchospasm in patients with chronic lung disease. Before initiating inhaled TI, perform a detailed medi-cal history, physical examination and spirometry (FEV1) to identify potential lung disease in all patients. The FDA also approved TI with a Risk Evalua-tion and Mitigation Strategy (REMS), including a communication plan to inform health care professionals about the serious risk for acute broncho-spasm associated with the medication, its contraindications and of the need to evaluate patients for lung disease before starting on TI.

Use in pregnancy:3 Regular human insulin is useful during pregnancy for both pre-gestational and gestational forms of diabetes because of the need for precise control of maternal glucose levels and the limited information re-garding fetal effects of some of the oral hypoglycemic. Inhaled TI, however, has not been studied in pregnant women. It is classified by the FDA as a Pregnan-cy Category C. Therefore, TI should not be administered to a pregnant woman unless the potential benefits to the mother justify the potential risk to the fetus.

Pediatric use:3 Inhaled TI has not been studied in patients younger than 18 years of age. Its use is not recom-mended at this time.

Clinical efficacy:1,2,3,4,5 Efficacy and

safety of inhaled TI has been studied in a total of 3,017 patients, including 1,026 with DM1 and 1,991 with DM2.1 FDA approval of TI was based primarily on two unpublished clinical studies which are summarized in the Afrezza® prescribing information.2,3 Review of clinical efficacy based primarily on these two trials is due to earlier trials utilizing a different inhaler device (Med-Tone inhaler) and possible significant differences in the devices.2,4

Inhaled TI was studied in adults with DM1 in combination with basal insulin in a randomized, open-label, active-controlled, 24-week clinical trial (n=344).3 The efficacy of TI in patients with inadequately controlled type 1 diabetes patients was compared to insulin aspart in combination with basal insulin. Patients underwent a four-week optimization period with basal insulin and then were randomized to receive inhaled insulin (n=174) or insulin aspart (n=170) at every meal, with doses titrated for 12 weeks followed by stable doses for another 12 weeks. The adjusted mean reduction in HbA1c from baseline with basal insulin plus inhaled insulin (-0.21 percent) was noninferior to the reduction with basal insulin plus insulin aspart (-0.4 percent) at 24 weeks. Significantly fewer (13.8 percent) patients who received inhaled insulin achieved an HbA1c of 7 percent or less compared with insulin aspart (27.1 percent). Inhaled TI was noninfe-rior to insulin aspart in reducing mean HbA1c, but was not as effective as insulin aspart in achieving an HbA1c of 7 percent or less in patients with DM1.

The efficacy of inhaled TI also was evaluated in DM2 patients. This trial compared TI to placebo inhalation in patients with DM2 who were uncon-trolled on metformin alone or a combi-

nation of two or more oral medications. This was a randomized, double-blind, placebo-controlled, 24-week clinical trial which enrolled 479 patients with DM2.3 Patients were randomized to receive inhaled insulin (n=177) or placebo (n=176), with insulin doses titrated for 12 weeks followed by stable doses for another 12 weeks. Doses of oral antidiabetic agents were kept sta-ble throughout the study. The addition of inhaled insulin significantly reduced the adjusted mean HbA1c from base-line compared with placebo (-0.82 percent vs -0.42 percent) at 24 weeks. Of patients who received inhaled insu-lin, 32.2 percent achieved an HbA1c of 7 percent or less compared with 15.3 percent of patients who received placebo. The authors concluded that the addition of inhaled insulin to oral antidiabetic agents significantly re-duced the adjusted mean HbA1c from baseline compared with placebo.

Advantages of TI: Fear of injection is often cited as a patient barrier to the acceptance of adding insulin to their diabetic therapy.2,4 For patients who would benefit from using insulin, TI provides another option to administer insulin that is not an injection. Through-out the clinical trials, a significant number of patients reported improved comfort, less confusing administration, ease of dosing, less pain and overall satisfaction when using the inhaled insulin.5 These elements may help to increase early initiation of insulin, pos-sibly improving glycemic control and patient outcomes.

Disadvantages of TI: While the inhaled route may provide a non-in-jection insulin delivery method, TI may only capture the interest of newly diag-nosed diabetics because others would



MatEria MEdica

have become accustomed to multiple daily injections and as a result would have less fear, anxiety, or perceived pain regarding injections. TI is not a substitute for long-acting (basal) insulin and thus will not eliminate the need for insulin injections in most patients. Additionally, recent advancements in the technology of insulin pens, includ-ing simplified use and shorter needles, have resulted in less pain, which also may reduce interest in an alternative delivery route. For some diabetics, this device may present a logistical challenge in terms of easily dosing the amount needed to cover a typical meal – it is currently only available in 4 unit and 8 unit cartridges. The FDA is requiring a Boxed Warning and a REMS program to inform health care professionals about the serious risk of acute bronchospasm associated with TI. There still remains a concern about its long-term safety and the risk of pulmonary malignancy. The FDA has

required the drug’s sponsor to conduct additional post-marketing studies to evaluate this potential risk further. Clinical trials with TI generally excluded asthmatics, patients with COPD, smok-ers, uncontrolled or advanced diabet-ics, and children, so until further data is gathered its use should be in this limited and specific study population. Inhaled TI costs approximately twice as much as rapid-acting insulin injections.

Cost information:6 The approxi-mate cost for one package containing 60 – (8 unit) and 30 – (4 unit) cartridg-es of Afrezza® and two inhalers is ~$ 278.60.

Conclusion: TI is a new form of inhaled human insulin approved by the FDA in July 2014 for the treatment of DM1 and DM2. TI has been shown to be non-inferior to rapid-acting insulin in DM1 and its efficacy demonstrated in placebo-controlled trials in patients with DM2. Patients generally tolerated TI well, with the most common adverse effects being increased cough, throat

pain or irritation. Rates of hypoglyce-mia and weight gain were similar to other insulin regimens, and there was no significant decline in pulmonary function (FEV1) over one year of use. Inhaled technosphere insulin should serve as an alternative insulin delivery for patients seeking a non-invasive therapy to replace injectable prandial insulin. Inhaled insulin absorption in patients with chronic pulmonary prob-lems may be a concern, but evidence is limited at this time. TI is significantly more costly than subcutaneous forms of insulin. However, the option of a non-injectable form of insulin may be appealing to patients who would be otherwise hesitant to initiate or intensify insulin therapy.

Dr. Freedy is a clinical pharmacy specialist in medicine/drug information at Allegheny Health Network, Allegheny General Hospital. He can be reached at (412) 359-3192 or [email protected].

From Page 207

References1. Food and Drug Administration. FDA approves Afrezza

to treat diabetes. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm. Accessed March 25, 2015.

2. Wesley N, Trujillo J, Ellis SL. Technosphere Insulin (Afrezza): A New, Inhaled Prandial Insulin. Ann Pharmacother 2015;49(1):99-106.

3. Afrezza® (insulin human) Inhalation Powder. Product information. Danbury, CT: MannKind Corporation. October 2014.

4. FDA Briefing Document. Endocrine and Metabolic Drugs Advisory Committee Meeting. www.fda.gov/down-loads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf. Accessed March 25, 2015.

5. Kugler AJ, Fabbio KL, Pham DQ, Nadeau DA. Inhaled Technosphere Insulin: A Novel Delivery System and Formu-lation for the Treatment of Types 1 and 2 Diabetes Mellitus. Pharmacotherapy 2015;35(3):298-314.

6. An Inhaled Insulin (Afrezza). Med Letter Drugs Ther 2015;57:34-35.

Free classified ad onlinePlace a classified advertisement in the Bulletin, and your ad will appear online FOR FREE on the ACMS website, www.acms.org,

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Allegheny County Medical Society members: The new world of Health Care ushered in by the Patient Protection and Affordable Care Act (ACA) has created uncertainty and confusion for most people. There are new regulations and requirements. Individual and employer mandates. Penalties for not purchasing coverage. On Exchange and Off Exchange access. As an Allegheny County Medical Society member, you have help.

Talk to USI Affinity, the ACMS’s endorsed insurance broker and partner. Our benefits specialists are experts in Health Care Reform. We can help you choose a health plan that provides the best coverage and value while ensuring you will be in compliance with complex new IRS and Department of Labor regulations. We’ll also provide you the kind of world class service and support you need to make sure you get the most out of your health care benefits after you buy.

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Demand, need and opportunity abound: The epidemic of abuse of

prescription drugs and heroin contin-ues unabated. With the passage last year of Act 191, which established a database for all controlled substance prescriptions dispensed in Pennsylva-nia, it is likely that even more opi-oid-dependent persons will be seeking office-based medication assisted treatment (hereinafter, MAT) with bu-prenorphine, a Schedule III controlled substance. By many accounts, there are not enough physicians to treat them.

Should you consider becoming authorized to prescribe buprenorphine to such persons? After all, it’s not that difficult for a physician to obtain a DATA 2000 waiver: Obtain 8 hours of training (which can be done in-person or online) and submit a Waiver Noti-fication Form (form SMA-167, which can be submitted online) to the Center for Substance Abuse Treatment, and in 45 to 60 days, you can receive your “x” number from the Drug Enforce-ment Agency (DEA) and start treating opioid-dependent patients.1 Sure, for the first year you are limited to a small patient load – up to 30 patients at a time – but after that, you can submit another notification and begin treating up to 100 patients at a time. That’s when your efforts really start to pay off financially. Before you start providing MAT, however, there are significant legal issues that must be considered.

DEA requirements. While the pro-cess for obtaining a DATA 2000 waiver is not particularly arduous, compliance with every aspect of the relevant DEA regulations is essential, as physicians with DATA 2000 waivers become subject to DEA inspections and audits. The DEA will review records to deter-mine whether you (a) adhere strictly to the limits on the number of patients treated at a time, (b) maintain ade-quate records and (c) are capable of referring patients for the psycho-social services that are considered a neces-sary adjunct to MAT. Failure to adhere to DEA requirements can result in the revocation of your DATA 2000 waiver and, if other significant violations also are found, the loss of your DEA num-ber altogether.

State requirements. The State Board of Medicine regulations require physicians to take certain steps before prescribing controlled substances. These include: conducting an initial medical history and physical examina-tion; re-evaluating the patient; counsel-ing the patient regarding the condition diagnosed and the drug prescribed; and maintaining accurate and complete medical records documenting the eval-

uation and care received by patients. In addition, once the Act 191 database becomes operational, prescribers will be required to query the system for the first time the patient is prescribed a controlled substance and, thereaf-ter, if the prescriber believes that a patient may be abusing or diverting drugs. Such queries will need to be documented in the medical record to demonstrate compliance with this requirement.

Enhanced confidentiality. Drug and alcohol treatment records are afforded a significantly higher level of confidenti-ality than other medical records. Under Pennsylvania law, such patient records may be disclosed “only with the pa-tient’s consent and only (i) to medical personnel exclusively for purposes of diagnosis and treatment of the patient or (ii) to government or other officials exclusively for the purpose of obtaining benefits due the patient as a result of his drug or alcohol abuse or drug or al-cohol dependence.” 71 P.S. §1690.108. Physicians must be prepared to comply with the restrictions on disclosures of such records and, if billing insurance, thoroughly understand the limited information that may be disclosed to substantiate claims.

Other clinical requirements. Patients in MAT must receive drug screen-ings. At the initial evaluation, the drug screening is necessary to demonstrate that they are, indeed, opioid dependent (and not seeking a buprenorphine

Part-time buprenorphine practice: legal considerations

Beth anne jaCkson, esq.

lEgal rEPort

lEgal rEPort


prescription to divert/sell the drug) and, subsequently, to ensure that they are taking the buprenorphine and not taking other drugs. This requires a relationship with one or more third-par-ty laboratories that will give you quick turnaround on results. Alternatively, drug screening cups may be used, but they must be approved CLIA-waived test kits, and you must hold a CLIA waiver certificate from the Pennsylva-nia Bureau of Laboratories to conduct such tests in your office. In addition, you need to ensure that there are pharmacies close to where you are providing MAT that will stock buprenor-phine and honor your prescriptions. This can take some effort on your part to educate the pharmacies and phar-macists about your patients and your practice so that they do not refuse to fill your prescriptions.

Contractual limitations. If you are a hospital employee, or are an employ-ee and/or shareholder of a physician group, your employment contract and shareholder agreement, as applicable, may require approval of activities out-side of your main clinical practice. Fur-ther, approval may be required by the board or other shareholders if you want to provide MAT at the office where you

regularly practice. These agreements should be reviewed, and any required approvals secured, prior to investing significant efforts into obtaining a DATA 2000 waiver.

Malpractice insurance. As with any medical activity, you are required to carry malpractice insurance coverage at state-mandated levels. If you are employed, your employer-provided coverage generally will not cover out-side activities. If you intend to provide services within your current practice, you will need to disclose your new service line to your insurance carrier to ensure that your policy provides adequate coverage.

Standard of care. Meeting the various requirements of the DEA and State Board of Medicine will not neces-sarily ensure that you are meeting the minimum standard of care in providing MAT. When a physician is sued for mal-practice, the standard of care must be established by expert testimony. If you are going to provide MAT to opioid-de-pendent patients, you want to be confi-dent that you can meet the standard of care described by the plaintiff’s expert (likely a physician with board certifica-tion in addiction medicine). If the expert calls your qualifications into question,

you do not want to be in a position of having to defend the fact that you took the requisite eight hours of training and nothing else. Rather, you want to be able to establish that you have contin-ued your education in MAT, attended CME and kept up with the literature on the subject, consulted with specialists caring for your patients’ significant comorbidities (e.g., psychiatric, hepati-tis B and C, HIV, tuberculosis, etc.) and perhaps even utilized the services of an experienced physician as a mentor when you began providing MAT.2

Setting: where and with whom to practice. It was the goal of the legisla-tion authorizing the DATA 2000 waivers to liberate treatment of addiction from methadone clinics, where patients had to come every day for their medication and, instead, to mainstream treatment for opioid dependence into the phy-sician office setting where it could be treated alongside other medical con-ditions. Physicians wishing to provide MAT have several options regarding the office setting in which to practice: one’s own office; the office of a physi-cian practice specializing in MAT; in an outpatient drug and alcohol treatment center licensed by the Pennsylvania

JACKSON

BETHANNE

Esq. LLC

4050 Washington RoadSuite 3NMcMurray, PA 15317

724 [email protected]

Serving the legal needs of health care practitioners and facilities

• Regulatory - Stark, Anti-Kickback, HIPAA, EMTALA

• Compliance training and policies

• Physician-hospital contracts

• Employment contracts

• Joint ventures and other business transactions

• Operational issues and policies



Department of Drug and Alcohol Programs (DDAP); or in an outside office managed by a third-party manager. Each of these has its merits, drawbacks and risks:

• Setting up your own practice requires a lot of preparation, including: preparing your own policies and forms that conform to applicable law and best practices; establishing appropriate referral and other relationships with counselors, other health care providers, laboratories and pharmacies; training staff; establishing how you will bill (cash-based vs. billing insurance3); and establishing methods to ensure that MAT-related records have the enhanced confidentiality protection required by law.

• Practicing MAT in another physician practice is typi-cally done on an independent contractor basis with hourly, daily or per-patient compensation. While this setting has the advantage of being a ready-made practice setting with existing policies, forms, trained staff and possibly experienced physicians who can serve as mentors, you will have less autonomy and, in addition, may become subject to non-competition covenants. Make sure that you have thoroughly vetted the practice prior to signing on to ensure that it adheres to appropriate standards. Review their forms, policies and procedures – would you be comfortable following them? Visit the office while patients are being treated – is someone monitoring to ensure that no illegal activity is occurring? Check the licenses of the physicians that are practicing there – have they been dis-ciplined? Speak with pharmacists and others in the com-munity – are there complaints about the practice? Once you have determined that the practice is acceptable, have an experienced health care attorney review your contract prior to signing to protect your interests.

• Providing MAT in a DDAP-licensed outpatient facility with a buprenorphine waiver (a “clinic”) makes you part of a team providing comprehensive care to opioid-depen-dent persons. Clinics are headed by project directors who must meet certain regulatory standards. Although policies and procedures have been reviewed and approved by DDAP, you still need to conduct some due diligence. Veri-fy the clinic’s license. Observe the operation of the clinic – do they actually follow their policies and procedures? Call DDAP – has the clinic been the subject of complaints? If so, has the clinic responded to the complaints in a way that satisfied DDAP that they were in compliance with the regulations? What role will you be expected to play – will

lEgal rEPort

From Page 211AlleghenyMedcare

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you only be providing MAT or do they need you to be a medical director as well? If so, do you meet the require-ments to be the medical director? Again, have any agreement reviewed by a health care attorney experienced in such arrangements.

• Practicing in a “turn-key” envi-ronment managed by a third party knowledgeable about MAT can be a viable option, but carries legal risk. To the extent that the manager is involved in any clinical decision-making and/or shares in the profit from your practice, the arrangement could violate the Pennsylvania prohibition of the corpo-rate practice of medicine. Based on case law, but also supported by the Medical Practice Act, the prohibition on the corporate practice of medi-cine effectively prohibits unlicensed persons and most corporations from employing or contracting with physi-cians to provide professional medical services to patients. Exceptions in-clude professional corporations owned solely by licensed physicians, licensed health care facilities and HMOs. Your legal responsibilities under a practice

management will be the same as if you were operating your own practice because you are: You must develop and implement policies, procedures and forms, make all of the clinical de-cisions – including whether to accept a patient – and ensure your compliance with applicable federal and state regu-lations. The manager can only provide you with staffing and administrative services to carry out your directives. Do not, under any circumstances, enter into an arrangement in which the “manager” refers to the patient as his/hers, expects you to do nothing but sign prescriptions or attempts to ex-clude you from decision-making. Such arrangements do exist and participat-ing in one could cost you your license. If you are contemplating entering into any type of practice management ar-rangement, have it reviewed by experi-enced legal counsel so that you do not enter into an illegal contract or, worse, become accused by the State Board of Medicine of aiding in the unauthorized practice of medicine.

Final thoughts. The challenges and professional and legal responsibilities

inherent in providing MAT make it personally and financially worthwhile to do only if you are willing and able to take the time to gain expertise in the field and to ensure your compliance with federal and state requirements. Accordingly, before obtaining a DATA 2000 waiver and providing MAT, exam-ine your motives and consider whether your skill set and schedule would permit you to do so in compliance with the law.

DISCLAIMER: This article is for informational purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.

Ms. Jackson is the sole member of Beth Anne Jackson, Esq. LLC, a law firm that serves the legal needs of health care practitioners and facilities in southwestern and central Pennsylva-nia. She may be reached at (724) 941-1902 or [email protected]. Her website is: www.jacksonhealthlaw.com.

References1. It should be noted that mid-level providers

are not eligible for a DATA 2000 waiver. 2. The Providers’ Clinical Support System for

Opioid Therapies has both educational resourc-es and a mentoring program: http://pcssmat.org/mentoring/.

3. Note that if you are a participating provider with a Medicaid managed care organization, your contract prohibits you from charging Medic-aid enrollees out of pocket for covered services. MAT is a covered service under the Pennsyl-vania Medicaid program. Accordingly, if your practice operates on a cash basis (regardless of the setting), you must ensure that you do not treat enrollees of Medicaid managed care plans with which you are a participating provider or your contract with the plan could be terminated.

Moving?Be sure to let us know ....

We can update our system to better serve you! When your patients call, we will know where to send them. Call (412) 321-5030 to update your information.

PracticE MaNagEMENt


One of the more common billing challenges and areas of confusion

for medical practices that can deter-mine whether they are paid appro-priately is how they handle billing for non-physician practitioners (NPPs).

It is common for many practices to utilize NPPs such as nurse practi-tioners or physician assistants in their offices, hospitals and nursing facilities. NPPs, also referred to as “physician extenders,” are an excellent enhance-ment for patient care and treatment.

It can be uncommon, however, for medical practices to thoroughly under-stand the insurance enrollment and billing guidelines for NPPs to ensure appropriate reimbursement, and to be compliant with payer guidelines. How a practice comprehends these guide-lines, combined with how the practice deploys its NPP enrollment and billing methodology, can make all the dif-ference between lost revenues, or in some cases, overpayments that must be returned to payers.

Reimbursement rates can vary. NPP services may be paid at 100 percent (“incident to” a physician service) or 85 percent (NPP performing the service solo) of a payers’ allowed amount, the percentage being influenced by:

1. The employment relationship between the NPP and the practice – Payment for NPP services may be made only if the NPP represents a direct financial expense to the practice (actual qualified employer of the NPP or a leased/contracted employee).

2. Whether the patient is new to or established with the practice.

3. Type of service – Reimbursement is limited to the services that the NPP is legally authorized to perform by state law and the employment agreement; that are covered; and are considered medically necessary by the payer.

4. Place of service – Reimburse-ment and claim format guidelines vary depending upon whether the services are office-based, hospital-based, or provided in a nursing/skilled facility.

5. The physical location of the phy-sician at the time and place where the NPP is seeing the patient.

Payers vary in their definition of what constitutes NPP “supervision” for the purposes of obtaining the 100 percent reimbursement. For example, in an office setting, Medicare defines “incident to” services (and allows 100 percent reimbursement) as the physi-cian being present in the office suite during the provision of NPP services. Highmark (commercial plans), how-ever, defines “incident to” as the physician being immediately available physically OR by electronic means.

It has not been uncommon for our firm to be called in to advise in situa-tions where a practice is undergoing a

payer audit and we find that services provided by an NPP were submitted on a claim under the physician’s name, even when the “incident to” billing guidelines were not met. This can result in overpayments for which the payer is requesting significant payback from the practice.

Conversely, we find practices that are collecting less than their entitle-ment from payers. The fear of overbill-ing causes the practice to submit “in-cident to” services in the NPP’s name, thus robbing them of reimbursement even when “incident to” billing guide-lines are met. This results in lower payer reimbursement than the practice deserves for NPP services.

Neither outcome is a desired out-come. Our goal is that every medical practice receives the correct reim-bursement – no more, no less – and that the billing process is compliant.

When utilizing NPPs, achieving the goal of correct reimbursement requires:

1. Thorough knowledge of payer en-rollment guidelines for NPPs. For many payers, the enrollment (and billing) guidelines for nurse practitioners differ from those for physician assistants.

2. Complete comprehension of clin-ical documentation requirements when utilizing an NPP. As with the enroll-ments, these may differ by payer.

3. Advance planning with how a practice schedules the NPP to achieve maximum reimbursement, when pos-sible.

4. Creating a billing workflow that

What medical practices need to consider when billing for non-physician practitioners

Focus on nurse practitioners and physician assistants

Donna j. kell, Bs, mPm

PracticE MaNagEMENt


clearly indicates the services the NPP provided, the services BOTH the NPP and physician provided, and under which practitioner the claim should be submitted.

5. Careful set-up of insurance claim formats, particularly with the informa-tion that appears in Box 24J (rendering provider) and Boxes 31 and 33 (billing provider).

6. Periodic internal monitoring to ensure that payer billing and docu-mentation guidelines are met and that reimbursement is appropriate to the practitioner reported on each claim submitted.

As you’ve probably realized by now, designing this process for your unique practice is a complex undertaking. I’ll be presenting specifics about how to navi-gate this maze at the Allegheny County Medical Society on Thursday, May 21.

If you cannot attend my talk, or want

to dive into the details on your own, here are a few places to start your journey:

• CMS Medicare (and Medicare Advantage products)

–‘Incident To” Medicare Benefit Poli-cy Manual, Chapter 15, Section 60

–MLN Matters Number SE0441www.cms.gov• Billing of Shared/Split Evaluation

and Management Services www.novitas-solutions.com• Highmark Commercial products–Medical Policy Z-27: Eligible Pro-

viders and Supervision Guidelines–Medical Policy Z-10: Services of

Physician’s Assistants–Medical Policy S-16: Assistant

Surgery Eligibility Criteriahttps://navinet.navimedix.com• AAPC (American Academy of Pro-

fessional Coders) website – Articles–Medicare’s Split/Shared Visit Policy

–Share or Split E/M Services?www.aapc.com

Disclaimer: The information in this article is not inclusive of all clinical/billing situations, nor are the resources listed exhaustive. Only after compre-hensive study of each practice situation can one determine the payer guide-lines to be applied and implemented.

Thanks to Jane Louik, RN, Esq., CPC, CPC-H, who provided research that supported this article.

Donna J. Kell is CEO of the Kell Group, LLC, is your Revenue-Building Partner, operating with her medical billing team located on the South Side of Pittsburgh. She can be reached at [email protected].

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32131-KellAd-ACMSB-QtrBbw.indd 1 12/18/13 10:47 AM

Thank You! The ACMS Foundation would like to thank the following individuals, businesses and organizations for their generous support and contributions to the 2015 Gala auction and program:

Big Burrito GroupBruce A. Wright, MDEliezer Barros Photography

Fabled Table CateringLeslie H. Latterman, MDMr. & Mrs. James Ireland

Omni BedfordPittsburgh SteelersSabika/Joanne Redondo

Venture OutdoorsWalt Disney World

“It’s just so overwhelming …” is the sentiment we hear most often from parents and family members when they talk about caring for a child with com-plex medical conditions. Even under the best of circumstances, this role can be extremely stressful for every member of the family.

Managing this care isn’t just tough on families; it’s also a challenge for professionals and the entire health care system. Nationally, about 4 percent of children are estimated to have complex medical conditions, but they account for more than one-third of all pediatric health care costs. For families of these approximately 15,500 children in our service area, arranging all their neces-sary services takes significant knowl-edge, coordination and communication.

At the same time, payers, pro-fessional organizations and even grant-makers are encouraging primary care physicians (PCPs) to move toward care coordination. It is a comprehen-sive, integrated approach to optimizing the full range of care a child or young person needs across medical special-ties, hospital systems and care settings.

Positive data on coordinated care outcomes is continuing to build. Results are showing more coordinated care, more accurate and timely information provided to multiple treating physicians, fewer hospitalizations and reduced lengths of stay, along with higher levels of family satisfaction.

For many years, we have recognized the value that a formal Care Coordina-tion Program could bring to our patients

and families. We’ve actually been coordinating care for inpatients at The Children’s Institute for more than 100 years, collaborating with families during each child’s stay and making arrange-ments for care when they go home. But as families take over these arrange-ments after their child is discharged, we continually hear from parents how daunting it is for them. Sometimes the health of their children worsens.

In response to this feedback from families, in 2014, we launched an initiative that enabled us to strategically build a team of experts and resources entirely dedicated to care coordination for patients and their families. The Care Coordination Program at The Chil-dren’s Institute is available not only to our patients, but also to any child with complex medical conditions in Western Pennsylvania that could benefit from the service. The program is funded by generous community donations, so we are able to offer it at no charge to health care professionals or parents.

Today, we are working with regional PCPs who are treating children and young people with complex medical conditions – including but not limited to acquired brain injury, congenital heart disease, cancer, spinal cord injury or multiple major diagnoses.

Our team consists of experienced

health care professionals including nurse care coordinators, health coaches, a social worker, program director and a medical director. All are focused on work-ing closely with families and providers to ensure that every child’s customized plan of care is effectively implemented. We use an evidence-based system that reflects the most up-to-date approach to care coordination. The involvement of our research team enables us to contin-uously evaluate the program and gives us the ability to measure outcomes. Our team members collaborate with referring physicians and parents and also are available for home, physician office and school-based meetings.

Participating health care profes-sionals tell us that they appreciate the expert support for the care they provide, the availability of information when they need it – and, ultimately, the best pos-sible health for their young, medically complex patients.

Depending on each family’s needs, care coordination may include:

• Making appointments for families with doctors, hospitals, therapists, in-home nursing, early intervention, testing centers, dentists, aides, medical equipment companies and others

• Ensuring that appointments hap-pen in the right order and in a timely way, and that providers share all neces-sary records and other information

• Identifying school and community resources – such as transportation –that can support each child and family

• Working with insurers on coverageThe program is tailored to each

sPEcial rEPort


Care Coordination Program introduced at The Children’s Institute

matthew masiello, mD, mPh, FaaP

sPEcial rEPort


family’s needs. Health care profes-sionals may refer a patient, or parents or guardians can refer their own child. Each family receives a care coordina-tor, a dedicated health coach, and a social worker who coordinates family needs with community resources. The child’s health and care program evolves through continuous monitoring and ongoing coordination. Our teams meet with parents and physicians regularly to re-assess the care plan and discuss any needed changes.

While evidence is mounting that it helps contain overall health care costs, care coordination also is delivering some very personal benefits for families:

• Healthier children, because they are receiving the right care in the right order

• Fewer emergency department visits and acute-care hospitalizations

• Fewer school absences for kids and work absences for parents

• Less stress and more time for par-ents because they no longer have to spend hours making appointments and otherwise coordinating their children’s care

• Lower out-of-pocket expenses for families (such as fewer co-pays, trans-portation costs, supplies)

At The Children’s Institute, we have a long and extensive history of provid-ing pediatric rehabilitation care for ev-erything from traumatic brain and spinal cord injuries, and highly complex med-ical conditions to simple sports-related injuries, so it was a natural progression for us to build this program.

By demonstrating the value of proac-tive, seamlessly coordinated care, our goal is that this initiative will become a replicable national model, resulting in better health outcomes, lower health costs and significant relief for over-stressed families throughout the region.

Contact the Care Coordination Pro-gram at The Children’s Institute at (412) 420-2599 or visit http://www.amazin-gkids.org/carecoordination for more information or to determine whether your patient can be enrolled.

Dr. Masiello is the chief medical officer at The Children’s Institute of Pittsburgh and medical director of the Care Coordination Program. He can be reached at (412) 420-2270 or [email protected].

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ProfilE


John P. Williams, MD, was recog-nized at the Allegheny County Med-

ical Society Foundation Gala this past March for serving as the 150th presi-dent of the society. Dr. Williams is the immediate past chair of the Department of Anesthesiology at the University of Pittsburgh, where he served as the Pe-ter and Eva Safar Professor of Anes-thesiology. Board certified in anesthe-siology and critical care medicine, Dr. Williams has dedicated his career to education and research with a clinical emphasis on cardiac illness and car-diac surgery. He previously served as chief at UPMC Presbyterian Hospital from 1999 to 2001 and as interim chair from 2001 to 2002. He also was the director of cardiac anesthesiology and co-director of intensive care at UCLA and the University of Texas, Houston. In addition, Dr. Williams serves as the senior director of Anesthesia and Pain in the Specialty Division of Mylan Inc.

Dr. Williams recently talked about what inspired him to become a physi-cian; his mentor, Dr. Joseph Gabel; his interest in education and research; as well as his family and interests outside of medicine.

Dr. Williams, what inspired you to become a physician and specialize in anesthesiology?

My father was a primary care physician (PCP) in the small town of La

Grange, Texas, where I grew up. That had a significant impact on my career choice. In addition, my older brother is a pediatrician, although now retired, and my younger sister is a practicing OB/GYN in Texas. I started out in ob-stetrics, but then fell in love with critical care medicine. When I was a resi-dent, the fastest way into critical care medicine was through anesthesiology, which is why I pursued the specialty.

You have served as a profes-sor and mentor to others over the years. Did you have a mentor who had a significant impact on your career?

Joseph Gabel, MD, was the men-tor who had the largest impact on my career choice. I consider him my “academic father.” I was going to enter private practice before I met him in 1980 at the University of Texas in Houston. I began working with him, and he fundamentally changed my career path. I followed him to UCLA, where I became the director of cardi-ac anesthesiology and co-director of intensive care. Dr. Gabel, who passed away in 1998, had a major impact on my life as a physician.

My mother, who was a high school economics, government and history teacher, also had a significant impact on my life as an educator and mentor. She later went back to law school at the University of Texas. She was the oldest law school graduate at the university at the time of her graduation. My mother

certainly instilled in me the importance of education, mentoring and the love of learning one can have at any age.

You have dedicated your career to education and research with a clinical emphasis on cardiac illness and cardiac surgery. Where did this interest in education and research stem from, and how has that carried over to your clinical practice?

My focus and attention on educa-tion and research within the medical profession began years ago. The idea of generating new knowledge and knowing something before anyone else does is incredibly appealing to me. An-swering hard questions with satisfying answers or solutions, to managing difficult problems, has always held a particular fascination for me.

Why do you think being part of organized medicine is so important?

If physicians do not care for their profession in all aspects, no one else will. Organizations such as the Allegh-eny County Medical Society (ACMS) and Pennsylvania Medical Society (PAMED) give voice and direction to the frustrations inherent in the modern day practice of medicine. We hope-fully act to answer the questions that physicians have with regard to the intrusion of a variety of outside forces into the practice of medicine. We also act to direct and enhance the practice of medicine for future generations.

What has your experience as a delegate to the American Medical

Meet your 2015 president: John P. Williams, MD

ChRistina e. moRton

ProfilE


Association (AMA) from Pennsylva-nia been like over the years?

It has been a fantastic experience. I have had the opportunity to meet a wide variety of physicians from all spe-cialties. I also have been involved in the development and direction of new ideas and approaches, to problems not only in medicine, but in some cases the regulatory burdens physicians face on a daily basis.

What are some of the main issues that you would like to address during your presidency?

Some of the issues that the society continues to address impact practicing physicians and others impact medical students. Maintenance of Certification (MOC) seems to be the biggest thorn

in the side of most practicing physi-cians today.

I do not know of one physician who does not believe that life-long learning and continued medical education are an essential part of being a physician. Unfortunately, in the opinion of many of the practicing physicians today, many specialty boards (responsible for the implementation of MOC), rather than ensuring physicians are continuing to demonstrate their professional qual-ifications, have instead focused on esoteric, time-consuming and expen-sive approaches to education.

This has given the impression to many practicing physicians (correctly or incorrectly is debatable) that these specialty boards are more interested in

making money than they are in serving the interests of their constituents and the safety of the public and our patients.

The PAMED in collaboration with the AMA wants to restore this focus and ensure that the American Board of Medical Specialties (ABMS) does its job in policing each of the medical specialties appropriately. This will insure that physicians do not perceive that their specialty boards see them solely as a captive source of revenue but rather as a constituency that needs their support and assistance in the quest to enhance education.

In regards to medical students, the cost of medical education must be addressed. Many medical students graduate with educational loans in excess of $200,000. The cost of med-ical education has a number of very problematic outcomes: It tends to drive students to choose specialties that are more highly compensated, instead of areas such as primary care and inter-nal medicine, simply because they are concerned with having so much debt, debt that will continue to incur interest as they enter into residency and fellow-ship programs. Medical students are concerned that they will not be able to afford that level of debt and continue to have a home and provide for their own family someday.

Mechanisms need to be in place to either defray the cost of medical educa-tion or otherwise encourage physicians to enter into primary care specialties. Some states are trying to accomplish this by offering incentive programs. For example, if a physician enters a rural health program or works at an inner-city practice for a certain period of time, their loans or federal grants will be re-paid as part of practicing in those areas.

Photo Provided

From left are Victoria (Tori) and Connor; Valerie Trott-Williams; John Williams, MD; Brynna; and Brynna’s fiancé, Victor Wasserman. Also pictured are the family dogs, Diamond and the late Bella.


ProfilE


Such focused programs reinforce for medical students that they do have options and can have a career in med-icine as a PCP and still have a family in a relatively smaller community. And the more one practices in a particular area, the more likely he or she will stay in that area.

To the extent that we can, we need to address some of these issues. It is certainly not easy. Some lend them-selves more easily under the direction of physicians, such as MOC, versus the cost of medical school education, which inevitably is going to become a societal decision about how funds are allocated within each state.

Tell me a little bit about your family.

My wife, Valerie Trott-Williams, and I have been married for 11 years. She is an assistant professor of accounting at Duquesne University and provides assistance to the chief medical and sci-entific officer on issues concerning stra-tegic development at UPMC. Between the two of us, we have three children: Brynna, Connor and Victoria (Tori).

Brynna is 25 years old and is graduating from the Graduate School

of Engineering at Boston University in May. She received her undergraduate degree in physics from the University of Richmond. She is engaged and will be getting married next spring.

Connor is 17 years old and will be graduating from Pine Richland in June. He will (probably) attend Duquesne University this coming fall with a major in accounting.

Tori is 16 years old and currently attends Vincentian Academy. She is a sports enthusiast and plays soccer and participates on the track team.

Finally, I can’t forget our pets! Our older dog, Bella, just passed away but was the family’s first dog and the best Mastiff ever. She was almost an angel-ic influence on our family and is sorely missed by everyone. Our little dog, Diamond, is a four-year old Puggle, who squeaks with delight every time we come home! She also misses Bella, though (she told us).

What are your interests or hob-bies outside of medicine?

I enjoy cooking and traveling. In the summer, I like to bike and hike. Ten years ago, my wife and I went to Tuscany to celebrate her birthday and took part in a biking, hiking and cook-ing tour. We had a wonderful time and

hope to repeat that experience in other parts of the world.

Do you have a final message for the ACMS membership?

The AMA’s catchphrase for many years was “Together we are stronger.” As trite as that may sound, I think it is absolutely true. Unfortunately, physi-cians sometimes lose sight of that reali-ty. Physicians often relate to the profes-sion of medicine most strongly through their own specialties. As physicians we have to remember that we are the ones who care most about the profession. As people inside the profession, we have a special responsibility to care, not only for our specialty, but rather the profession of medicine as a whole.

The ACMS, PAMED and the AMA are charged with ensuring that the profession of medicine continues to not simply exist, but to develop and grow and thereby enhance health care for our patients, friends and families. By belonging to those professional orga-nizations, you ensure the livelihood of the profession of medicine now and for the future.

Ms. Morton is a communications consultant. She can be reached at [email protected].

From Page 219

Don’t forget to submit your photos for the 2015 Bulletin Photo Contest!

The deadline for submitting photos is Friday, August 28, 2015. All photos should have a resolution of at least 300 dpi and should be

emailed to [email protected]. For more information, call (412) 321-5030, ext. 105, or email [email protected].


2016 Board and Delegate NominationsA Candidate for the ACMS Board of Directors:• Represents physicians on issues impacting the practice of medicine and makes policy decisions for the medical society.• Meets four times per year, special meetings as needed.

[Please print name] I am interested in the Board of Directors (Phone)

A Candidate for the ACMS Delegation to the PAMED:• Represents physicians of Allegheny County in creating statewide policy on issues impacting physicians, patients and the practice of medicine. • Meets as necessary prior to attending House of Delegates in October in Hershey, PA.

(Please print name) I am interested in the ACMS Delegation (Phone)

I would like to recommend the following individual(s) [Please print]

for Board Delegate

Please FAX completed form to (412) 321-5323 by Friday, June 5.

for Board Delegate

Thank you for your membership in the Allegheny County Medical Society

The ACMS Membership Committee appreciates your support. Your membership strengthens the society and helps protect our patients.

Please make your medical society stronger by encouraging your colleagues to become members of the ACMS. For information, call the membership depart-ment at (412) 321-5030, ext. 110, or email [email protected].

Affiliated with Pennsylvania Medical Society and American Medical Association


Allegheny County Health DepartmentSelected Reportable Diseases & Conditions*

Reportable Diseases 2015: Q1

Jan.-Mar. Disease/Condition 2015 2014 2013Campylobacteriosis 18 104 129Cryptosporidiosis 0 29 22Shiga-toxin producing Ecoli 2 6 34Giardiasis 15 74 96Guillain-Barre Syndrome 2 9 10Hepatitis A 0 4 4Hepatitis B (acute) 0 15 8Hepatitis C (confirmed) 347 1163 734Legionellosis 4 66 94Listeriosis 0 2 3Malaria 0 4 4Meningitis, Viral 3 38 35Haemophilus influenza Invasive Disease 2 12 19S. pneumoniae Invasive Disease, drug resistant 16 0 3Meningococcal Invasive Disease 1 0 2Pertussis 19 130 46Salmonellosis 18 106 105Shigellosis 14 31 9West Nile Virus Infection 0 0 0Tuberculosis 5 17 15AIDS* 19 89 90HIV* 34 155 147Gonorrhea 445 2,079 2,171Chlamydia 1,461 5,697 6,095Syphilis, Primary & Secondary 36 65 24Carbon Monoxide Poisoning 1 18 13*These case counts reflect definitions used by the U.S. Centers for Disease Control and Prevention to report national counts of notifiable diseases through the Morbidity and Mortality Weekly Report.**Subject to adjustment due to lag in case reporting.

Disease reports may be filed weekdays during regular business hours from 8:30 a.m. to 4:30 p.m. by calling 412-578-8060.

At all other times, please call the Health Department’s 24-hour telephone line, 412-687-2243.

For display or classified advertising information, contact Bulletin Managing Editor Meagan Welling at [email protected] or (412) 321-5030, ext. 105.

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