medical marijuana and a physician's role how a pcp can identify a

Allegheny County MediCAl SoCiety

BulletinSepteMber 2016

Medical marijuanaand a physician’s role

How a PCP can identify a good psychotherapist

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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.

BulletinSepteMber 2016 / Vol. 106 No. 9


ArtiCleS perSpeCtiveS depArtMentS

Materia Medica .................... 343Patiromer (Veltassa®): A new option for treating hyperkalemiaAlaina Koval

Special Report .................... 346Fine Foundation, JHF promote excellence in patient safety, health care qualityJewish Healthcare Foundation

Legal Report ....................... 348Medical marijuana and a physician’s roleBarry Nelson, Esq.

Editorial ............................... 322Maiden voyageDeval (Reshma) Paranjpe, MD, FACS

Editorial ............................... 324Now this!Charles Horton, MD

Perspective ......................... 326Whither the art of medicineRichard H. Daffner, MD, FACR

Perspective ......................... 328How a PCP can identify a good psychotherapist: The four T’s of therapyLeo Bastiaens, MD

Society News ...................... 330• Medical Student Career Night• Reminder from the AMA• Practice Administrators Forum• Medical student scholarships available• ACMS sponsoring first book on local history of medicine • Pennsylvania Geriatrics Society – Western Division

Activities & Accolades ....... 334

In Memoriam ....................... 334• Philip P. Ripepi, MD, FACS • Anthony R. Haradin, MD

ACMS Alliance News .......... 336

Classifieds .......................... 349

On the coverA Marsh North of Charleston, SCby Frederick Doerfler Jr., MD

Dr. Doerfler specializes in internal medicine.

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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.

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Anuradha Anand, MDThe physicians and staff of Medical Rehabilitation, Inc., are pleased to announce that Dr. Anuradha Anand has recently joined our practice. Dr. Anand is a Board Certified specialist in the field of Physical Medicine and Rehabilitation (“PM&R”). Her specialty interests are in work injuries and spinal cord injury. Prior to joining our team, Dr. Anand managed a PM&R medical practice in Queens, New York. Prior to her work in New York, Dr. Anand completed her residency in PM&R at Nassau University Medical Center in NY, as well as a one year general surgery internship at Montefoire Medical Center in NY.Dr. Anand is a graduate of AUC Medical School, and received her B.S. in Biology from the University of Michigan. Dr. Anand currently resides in the Wexford area with her husband and young daughter. During her free time Dr. Anand enjoys cooking and hiking with her family.She will be doing in-patient rounds at Health South Sewickley Rehabilitation Hospital and seeing out patients in our Cranberry and Mercy Offices.

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The other day, I received a telephone call from my mother, who asked me

to referee a dispute she was having with my father. Holding my breath, as most children of any age do in a situation like this, I gingerly asked the nature of the conflict.

My mother was signing up to be a member of some online website which shall not be named but which thought itself significant enough to require security questions in case one forgot one’s password. My father was reading over her shoulder unnecessarily, as fathers sometimes do. The standard dropdown list of security questions appeared, and my mother dutifully scrolled past all the standard ques-tions: Favorite pet’s name, Name of the street you grew up on, Childhood best friend’s name, Make of first car, First concert you attended, etc.

The security question to which she naturally gravitated was: Spouse’s maiden name.

She marked down: “Paranjpe,” to which my father took vigorous objec-tion, and the good-natured dispute began from there.

I then had the singular pleasure of hearing their opening arguments. My mother: “But that IS his maiden name. Why should only women have maiden names? This is such a sexist question!” My father: “Men don’t have maiden names. Women have maiden names. And besides semantics, of all ques-tions, why does she have to choose THAT question to answer? Couldn’t she just pick an easy, straightforward question, like the dog’s name, or the

name of her high school?”Now my parents lived through the

1960s and 1970s in their youth, and I would describe both as feminist/pro-women, lest you think otherwise about my father.

I put on my virtual Solomon hat and asked my father: “So what is a maiden name? Can we agree it’s the name someone has when they aren’t yet married?”

“Yes.” “And can we agree that a married

name is the name someone has after they are married?”

“Yes, of course.”“So what was your name before you

got married?”“Paranjpe.”“And what is your name after you

got married?”“Paranjpe.”“So that settles it, Dad. Paranjpe

is your maiden name. And therefore, technically, Mom is correct.”

(Mock-exasperated sigh from my father, punctuated by peals of laughter from my mother and myself.)

“Think of it. Suppose a woman named Susie Brown marries an unrelated man named John Brown. In that case, both Susie’s maiden AND married names are Brown. And for that matter, so are John’s! What’s to pre-

vent him from taking her name, or from hyphenating to Brown-Brown?”

“Those are the Browns. Let’s talk about the Steelers!”

We all had a good laugh, but then I started to think about what a horribly sexist question that really was! To ask the applicant’s spouse’s maiden name was to assume that the applicant was a man! What millennium are we in? Shouldn’t we be past all this 1950s thinking? But then I caught myself. Perhaps we ARE.

Today, same-sex marriage is legal in many states. Two women can get married to each other. Woman A could take Woman B’s last name, or vice versa, or neither. Or they could hy-phenate. So therefore, in the case of a lesbian marriage, “spouse’s maiden name” is not a sexist question at all – it is a remarkably progressive one.

If two men get married to each other, again, Man A could take Man B’s name, or vice versa, or neither, or they could hyphenate. And again, “spouse’s maiden name” becomes a remarkably progressive question rather than a sexist one.

And I am left feeling shaken be-cause I suddenly realize that in bristling at that simple question, I have been myopically viewing the world only through my own natural perspective – that of a straight woman. This, in spite of the fact that I myself had made the argument that “maiden name” refers to anyone’s last name before they are married. In immediately thinking that “spouse” in the question refers only to a woman, and that too a woman who is

Editorial

322 Bulletin / September 2016

Maiden voyageDeval (Reshma) PaRanjPe, mD, FaCs

married to a man, perhaps I’m the one who isn’t so progressive in my thinking!

Everything is rapidly changing in this current age, and so much depends on the filter through which we view the world. Sometimes, we have to step back and re-examine simple questions and what they really mean today. Sometimes, we have to step back and realize that we are looking at things with our own particular filters and bias, including things that make us offended or uncomfortable.

There is no right or wrong filter per se as long as we don’t pass judgment as physicians – we all have our own

filter and set of biases depending on how we were raised and who we are – but it’s important to realize that we may have biases of which we are not even aware, but which may figure in our in-teractions with other people, including our patients. We may make assump-tions which are wrong, or presume too much, or not ask important questions because we incorrectly assume things about the patient – whether it be sexual orientation, or cultural traditions, or economic situation, or a host of other issues.

The important thing is to be open-minded, aware of others’ view-

points and self-aware of our own filters. Before we take offense, let us examine the issue from other viewpoints. And thus begins our maiden voyage into the brave new world.

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

Editorial

323Bulletin / September 2016

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.

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In the Pixar movie “Ratatouille,” a jaded restaurant critic strides into the

protagonist Remy’s restaurant, and when the waiter asks what he’d like to have, he replies icily: “Perspective!” Brilliantly, the chef responds with an artistic reinterpretation of a childhood favorite – thus showing that he remem-bers he’s there to nourish both body and soul. The critic is left speechless.

For a long time, I’d seen this simply as a bit of clever storytelling by the masters at Pixar, resolving the tension between the existing restaurant world and a rat who wants to work as a chef. And yet, it’s more.

The two leading presidential candi-dates’ entire platform seems to be “At least I’m not the other person run-ning for president,” and through their respective shenanigans, an election for one of the most powerful offices on Earth is reduced to travesty. It breaks my heart: By rights, this election should have seen Ted Cruz square off against Bernie Sanders, amidst a vigorous public debate about the proper role of government in a free society. Instead, it’s sound bites, constantly shifting positions and debates about which Disney character would be the best protest vote.

In contrast to how lightly we’re taking the presidential election, in Rio we watched as a British gymnast fell hard, appeared to suffer a concussion, and then – with her coach’s apparent blessing – returned to the floor scant

minutes later. I completely understand why a young athlete, facing what’s likely her best chance to triumph on the world stage, would want to take risks to keep going. But why did the coach say yes?

Like the restaurants that left the critic so world-weary and bored, or the coach for whom the hope of a gold medal was worth sending a freshly concussed athlete back into action, too often we forget what is real and what’s just entertainment. We forget what counts.

In “I Am Not My Hair,” the R&B singer India.Arie laments that whatever hairstyle she chooses, it will be taken as a deep commentary on how she sees herself and who she considers herself to be. I got a small taste of this when, as a med student pressed for time, I put off haircuts long enough that I ended up tying it back in a ponytail – and suddenly was assumed to be a Cool Guy, perhaps a surfer or a guitar-ist. (If only!) The attention was gratify-ing, but felt a little superficial: Nothing had actually changed about me, except that I spent a little more on shampoo each month. On the other hand, when I did finally get it cut, everything returned to the old status quo: Suddenly I was just a guy, to be judged according to my character.

What does hair have to do with per-spective? It’s “personal branding,” to quote the popular term right now. Now it’s normal to care about reputation, whether your own or that of people you’re considering as associates – but this concept goes around whether

you’re a good guy or a bad guy, focusing instead on superficialities. Do you post often enough on Twitter and Facebook, and are your comments sufficiently interesting? Are you seeing and being seen? Do you do enough hey-look-at-me stuff to keep your name in the limelight?

With that in mind, our current candidates become a little less sur-prising. While their competitors were taking pains to articulate their beliefs and working to win one voter at a time, they were focusing instead on building an image. It matters little to our elec-torate that in both cases, the image bears little or no relation to the facts. It doesn’t need to: as Neil Postman noted presciently in “Amusing Ourselves to Death,” “The men were less concerned with giving arguments than with ‘giving off’ impressions, which is what televi-sion does best. Post-debate commen-tary largely avoided any evaluation of the candidates’ ideas, since there were none to evaluate. Instead, the debates were conceived as boxing matches, the relevant question being, Who KO’d whom?” Postman was talking about the 1984 election, comparing its fast-paced debates to the hours-long speeches in the Lincoln-Douglas Debates – one can only imagine what he’d have thought of candidates using Twitter!

Postman went on to comment that his least favorite words in the English language were “Now this” – used, as it commonly was, as a way of cleansing the mental palate between bite-sized pieces of news. It is not a coincidence that as our national attention span gets

ExEcutivE committEEEditorial


Now this!ChaRles hoRton, mD


shorter, we become more and more easily distractible. Facts do not need to be debated, nor positions articulated and defended; whatever is not helpful to a candidate only needs to be kept in the background long enough that it will become old news.

What, then, can we do? Like Pixar’s restaurant critic, we need to regain our perspective. Learn history. Study the issues. Turn off the screens – yes, all of them! – long enough to read books and have conversations. Trade the virtual for the real, the world of constant entertainment for the simple beauty of being alive. Consider the effects of media on how you think and on how you see the world. Encourage others through your example.

And vote for Remy.

Dr. Horton specializes in anesthesiology and is asso-ciate editor of the ACMS Bulletin. He 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.

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PErsPEctivE


*This is a follow-up to a previous Perspective column by the author.

During my long career as an ac-ademic radiologist, I frequently

heard the following from medical students and residents, “We have so much more to learn than you did when you were a student.” The first few times I heard that, I tended to agree. However, the longer I thought about it, the more I realized that because of the rapid changes in technology, perhaps there was, in fact, more to learn. On the other hand, maybe some of what we learned 50 years ago is no longer relevant as newer technology replaced the old. Two classic examples that come to mind are pneumoencephalog-raphy (PEG) and lymphangiography. In the first procedure, air was introduced into the subarachnoid space through a lumbar puncture and allowed to rise into the cerebral ventricular system in an effort to diagnose some brain tumors. Not only was the procedure unpleasant, but most patients also had severe post-procedural headaches, and in many cases vomiting. In the second procedure, a blue dye was in-jected intradermally between the toes. The dye would be absorbed by the lymphatic vessels, which could be then

cannulated using a 29g needle follow-ing a cut down to find the vessel. An oily contrast material was then injected slowly into the lymph vessels. X-rays would be taken of the pelvis, abdomen and chest afterwards to follow the path of the contrast. In addition to the discomfort and scarring from the cut-down procedure, the patients had to lie perfectly still to make sure the thin needle was not displaced. Some pa-tients turned a greenish blue from the vital dye. Fortunately, for both patients and radiologists, both procedures have been replaced by CT scanning and in the case of PEG by MRI.

So, we all agree the new technology is good. We no longer have to interrupt our daily routines with a trip to the library to check on a new procedure or medication. We have the Internet at our fingertips on our smartphones or a computer terminal. In fact, I suspect we physicians are spending less time at the patient’s side than at the computer. For many years I was a member of the Musculoskeletal Expert Panel on Ap-propriateness for the American College of Radiology. The College developed a series of Appropriateness Criteria to aid clinicians in selecting the most appropriate imaging studies depending on the patient’s symptoms and the clin-ical setting. Furthermore, the Internet is full of algorithms guiding the clinician

through diagnostic testing and therapy for most disease entities.

However, where the science of medicine has become triumphant, the art of medicine has apparently taken a back seat. From my conversations with medical students, there is less empha-sis on physical diagnosis and more on using technology to find out what is wrong with the patient and then treat him or her. I maintain that a good his-tory and physical examination should give the clinician an idea of what he/she is dealing with before ordering tests and imaging.

The quote at the beginning of this piece was from the late Dr. Miller, who was co-chair of the Department of Medicine at the then University at Buf-falo, School of Medicine (now Jacobs School of Medicine and Biomedical Sciences). Dr. Miller, who was known for his skill as a medical diagnostician, used an old stethoscope with the yellow-brown tubes and a bell chest piece. He could hear the faintest of heart murmurs and was an expert at differentiating the sounds. Most of my classmates had purchased the new lightweight Littman stethoscopes and one of them asked Dr. Miller when he was going to get one. He told us that he was happy with the one he had. But when one student told him how much better he could hear heart sounds with the Littman, Dr. Miller uttered his famous quote.

The art of medicine was more than just doing a careful physical examina-tion. It involved listening to the patient, looking for the classic signs that Galen described two millennia ago: calor

Whither the art of medicineRiChaRD h. DaFFneR, mD, FaCRThe most important part of

the stethoscope, doctor, is what is between the earpieces.

-David K. Miller, MD (1904-1997)


(warmth), dolor (pain), fetor (odor), rubor (redness) and tumor (mass), and paying attention to adages such as “a ticklish belly hides no pathology.”

In addition to living in an age of advancing technology, we also are in an age of cost-containment. Newer di-agnostic imaging and laboratory procedures have dra-matically changed the practice of medicine and reduced morbidity and mortality. However, perhaps spending a little more time with the patient and paying more attention to what they are telling us can result in fewer inappropri-ate studies being performed as well as improved patient outcomes.

Dr. Daffner is a retired radiologist who practiced at Allegheny General Hospital for more than 30 years. He is emeritus clinical professor of Radiology at Temple University School of Medicine and is the author of nine textbooks. He can be reached at [email protected].

PErsPEctivE

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.

Ruby Marcocelli

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PErsPEctivE

Primary care physicians (PCPs) see patients with mental health

problems on a daily basis. While many physicians are comfortable prescribing psychotropics, almost none has the training, experience or time to prac-tice psychotherapy. Evidence-based psychotherapies have been developed over the last three decades to treat different psychiatric disorders: for example, panic control therapy for panic disorder, exposure and response prevention for obsessive compulsive disorder, interpersonal social rhythm therapy for bipolar disorder and cogni-tive therapy for depression. However, as in other fields of medicine, the translation of research findings into real world practice has been slow and inconsistent. Many effective treatments are not being implemented in private practice or the public sector. So, how is a primary care doctor to decide who is an effective, evidence-based therapist?

While psychotherapies differ in their background and approach, some common factors can be identified. In this regard, it is useful to look at psy-chotherapy as a road trip: The starting point is the patient’s diagnosis, the target is remission of symptoms and restoring functionality, the roadmap is the theoretical conceptualization of the patient’s difficulties and the vehicles are the therapeutic techniques. It also helps to have a good relationship with your travel agent, the therapist.

So, let’s look at these different com-ponents. Here is what a physician can

ask or look for in the psychotherapeutic treatment of the patient: the four T’s of therapy.

1. What is the Theoretical conceptu-alization?

This question implies that a thor-ough diagnostic assessment has been performed. This assessment should include standardized rating scales of specific problems. After the evaluation, a therapist should have educated the patient about the conceptualization of the problems within one specified theoretical framework (i.e., behavioral, or cognitive, or interpersonal …). For example, from a cognitive therapist, this may sound like: “Due to your abu-sive upbringing, you most likely have developed a core belief of the world around you as being dangerous. Your compensatory mechanism to avoid this danger has been to isolate your-self from most social contact, which effectively reduced your anxiety but has left you with few skills to participate in society. However, as you became older, you were forced to take care of yourself and interact with people. This has reactivated your maladaptive belief, created many negative thoughts, and together with the lack of appropri-ate social skills, has led to depression and hopelessness.”

It cannot be overemphasized how important this theoretical conceptual-ization is for the effectiveness of psy-chotherapy: It is an ever-evolving map. When progress slows, the conceptual-ization can shed light on the reasons; when obstacles, “roadblocks,” are identified, the conceptualization can create an appropriate detour. Without a conceptualization, the blind leading the blind may characterize a never-ending journey.

2. What are the Targets in the treatment?

Treatment targets should be spelled out explicitly and should be SMART: Specific (NOT: I will be more social, BUT: I will have a conversation with five different people in the next week); Measurable (five conversations); Achievable (conversation with mail-man, cashier in store, neighbor …); Realistic (conversation for at least one minute about the weather); Time-spe-cific (in the next week). Larger goals need to be broken down in smaller steps.

3. What are the Techniques?Many evidence-based psycho-

therapies bring a didactic side to the road trip: teaching specific skills to be rehearsed and practiced as home-work assignments in between therapy sessions. Examples of techniques are anxiety management skills (deep breathing or muscle relaxation skills), thought recordings, problem solving skills, different communication skills, hierarchical exposure tasks, sleep hy-giene measures, mindfulness training,

leo Bastiaens, mD

How a PCP can identify a good psychotherapist: The four T’s of therapy


etc. Other helpful activities may include bibliotherapy, Web-based programs, listening to audio recordings of previ-ous therapy sessions and the like.

4. What about the Therapeutic relationship?

The role of the patient and the therapist should be explicitly stated: collaboration in identifying appropriate targets and techniques, responsibility for homework assignments and review, providing mutual feedback, safety planning, etc.

While the details may differ between different types of psychotherapies, the four T’s provide a framework that therapists or patients should be able to relate back to the referring PCP. Like with any other consultation, the physi-cian should receive feedback and be able to judge the effectiveness of the referral.

This framework can be used to select therapists for referrals. The physician can provide the patient with a referral form stating the reason for the referral but also requesting feedback from the therapist, to be documented on the same form and to be returned to the medical office. The form can list the questions pertaining to the four T’s, to be answered by the therapist (example included). Without an in-depth knowledge of the different therapy approaches, the physician will

be able to see who is providing up-to-date psychotherapy by identifying a cohesive and logical description of the different components.

Psychiatric disorders are prevalent conditions that interact in a biopsycho-social manner with general medical conditions. Their treatment should be regarded as important, feasible and understandable, as any other medical condition.

Dr. Bastiaens is a board-certified general and child and adolescent psychiatrist who received psychiatric training at Mount Sinai Medical, N.Y., and Harvard University, Boston. He is a clinical associate professor of Psy-chiatry at the University of Pittsburgh School of Medicine, and is a certified member of the Academy of Cognitive Therapy. He can be reached at [email protected].

PErsPEctivE

Dear (therapist),

I am the primary care physician for (patient’s name). I am concerned that (patient’s name) is suffering from (depression, generalized anxiety….). I am referring her/him to you for psychotherapeutic treatment.

After your evaluation, please return this form with the information re-quested filled out. I am interested in referring my patients to therapists with experience in evidence-based psychotherapy and the requested informa-tion will help me understand the treatment and guide future referrals.

1. What is the conceptualization (within which specific psychotherapeu-tic modality) of the patient’s problems?

2. What are the initial psychotherapeutic targets?3. What are the therapeutic techniques that will be used? What home-

work assignments will be part of the treatment?4. What will be the patient’s responsibilities within the therapeutic rela-

tionship with you?Thank you for your collaboration in the care of (patient’s name).

Sincerely,

ACMS Members:Professional announcement advertisements

are available to ACMS members at our lowest prices.Contact Meagan Welling, managing editor, at [email protected].

Congratulatory message?

Retiring? New Partner?

New Address?


sociEty NEws

Medical Student Career Night scheduled for October 20

The University of Pittsburgh’s medical student AMA chapter is hosting a career night Thursday, Oct. 20, at the Herberman Conference Center, 5150 Centre Ave., Pittsburgh, 15232 (connected to UPMC Shadyside). Reg-istration begins at 6 p.m.; dinner and rotations at 6:30 p.m.; and conclusion at 8:30 p.m.

Co-chaired by Mr. Fred Brown and Mr. George Gabriel, both MD candidates, Class of 2018, University of Pittsburgh School of Medicine, the informal program serves as a “career exploration” for medical students by providing an opportunity to speak with physicians to learn about a variety of specialties.

In question-and-answer roundta-ble-by-specialty sessions, physicians will have the opportunity to provide in-sight into their respective specialty and address questions such as: what it’s like to practice on a day-to-day basis; why they chose a specific specialty; what attributes are important to med-ical students considering a specialty; and how to balance career and person-al life.

In conjunction with the event, we are seeking practicing physicians to mentor students by also providing a shadowing opportunity. This experi-ence would be held at a later date (de-termined by the physician and student).

This annual event attracts more than 100 medical students who are eager to candidly discuss specialties with practicing physicians. The pro-gram provides a refreshing opportunity for physician participants to interact and engage with medical students as they continue their journey to becoming a physician.

Physicians interested in participat-ing Oct. 20; providing a shadowing experience at a later date; or attending and mentoring can reply by visiting the ACMS website www.acms.org; email-ing Nadine Popovich at [email protected]; or calling the Society office at (412) 321-5030. ACMS members will receive complete information on the medical student career night by email closer to the program date.

Important reminder from AMA about billing requirements

As part of the American Medical Association’s (AMA) ongoing work with the Centers for Medicare & Medicaid Services (CMS) on issues affecting Medicare providers and beneficiaries, the AMA would like to remind physicians that balance billing is prohibited for Medicare beneficiaries enrolled in the Qualified Medicare Beneficiary (QMB) program. CMS has conveyed their con-cern that some physicians are still billing QMB beneficiaries, despite the existing prohibition.

The QMB program is a Medicaid program that helps very low-income dual eligible beneficiaries – e.g., individuals who are enrolled in both Medicare and Medicaid – with Medi-care cost-sharing. Beneficiaries in the QMB program have annual incomes of less than $12,000. Federal law protects QMBs from any cost-sharing liability and prohibits all original Medicare and Medicare Advantage providers – even those who do not accept Medicaid – from billing QMB individuals for Medi-care deductibles, coinsurance, or co-payments. All Medicare and Medicaid payments that physicians receive for furnishing services to a QMB individual are considered payment in full.

It is important to note that these billing restrictions apply regardless of whether the state Medicaid agen-cy is liable to pay the full Medicare cost-sharing amounts (federal law allows state Medicaid programs to re-duce or negate Medicare cost-sharing reimbursements for QMBs in certain

Medical students listen to physician volunteers at Medical Student Career Night held Oct. 13, 2015.

Continued on Page 332


From Page 330

circumstances). Physicians may be subject to sanctions for failing to follow these billing requirements, and CMS has indicated that they may start conducting more frequent audits to address this practice.

For more information, visit www.cms.gov.

Programs continue for Practice Administrators Forum

The ACMS Practice Administrator’s Forum continues its monthly meetings with the following program offerings. All meetings begin with registration at 8 a.m., followed by the program at 8:30 a.m. and conclusion at 10:00 a.m.

• September 15: OIG Review and Legal Update, presented by Beth Anne Jackson, Esq.

• October 20: Feedback Training for Managers: How to Be Heard, Help Others and Ignite Change, presented by Joe Mull. Feedback is a skill. It requires training and practice. Master the art of giving feedback and you’ll end up with teams that trust you and

physicians who want to hear your opinion. ACMS members and affiliates receive a 40 percent discount (General Admission price $199; Discount price just $119). To register, visit www.mullfeedback2016.eventbrite.com.

• November 17: Patient Collections, presented by Donna J. Kell

• December 8: Round Table – Prac-tice Management Best Practices

Foundation of PAMED offers medical student scholarships

The Foundation of the Pennsylvania Medical Society, a nonprofit affiliate of PAMED, sustains the future of med-icine in Pennsylvania by providing programs that support medical educa-tion, physician health and excellence in practice. It has been helping finance

physician education for more than 60 years.

“We recognize that medical stu-dents play a vital role in the future of medicine in Pennsylvania, so we proudly administer scholarships to deserving students across the com-monwealth,” said Heather Wilson, the Foundation’s executive director.

Applications for the following schol-arships will be accepted July 1–Sept. 30, 2016:

• Allegheny County Medical Society Medical Student Scholarship. Resi-dents of Allegheny County can apply for a $4,000 award. Applicants must be enrolled full-time at a Pennsylvania medical school as third- or fourth-year students.

• Endowment for South Asian Stu-dents of Indian Descent Scholarship. Pennsylvania residents of South Asian Indian heritage may apply for this $2,000 award. Additionally, applicants must be enrolled full-time as second-, third-, or fourth-year students at a Pennsylvania medical school.

Additional scholarships available with alternate deadlines:

Attendees are pictured with presenter Joe Mull, MEd, far right, during a Practice Administrators program in April 2016.

sociEty NEws

Ms. Jackson

Ms. Kell


sociEty NEws

• Alliance Medical Education Schol-arship. Pennsylvania residents attend-ing a Pennsylvania medical school as second- or third-year students may apply for a $2,500 award. Multiple recipients will be selected. Postmark deadline: Feb. 28.

• Scott A. Gunder, MD, DCMS Presidential Scholarship. Second-year students at Penn State University Col-lege of Medicine who are Pennsylvania residents may apply for this $1,500 award. Postmark deadline: April 15.

To find out more about scholarships, call the Foundation at (717) 558-7852, or visit the Student Financial Services page at www.foundationpamedsoc.org.

ACMS sponsoring first book on local history of medicine

The first comprehensive history of the practice of medicine in Allegheny County is in development with plans for a winter 2017 publication.

This will be a handsome, hard-cov-er, illustrated history of the develop-ment of medicine in Pittsburgh, cov-ering more than 200 years of medical advancements and achievements by doctors including Salk, McGovern and many other medical pioneers who have made our medical community one of the finest in the world.

The book will recognize the contri-butions the Allegheny County Medical Society has made since its inception more than 150 years ago. We have a legacy of which we can be very proud. With the use of a comprehensive distri-bution plan, all who see or read about our history will be more aware of the important work in evolution of medical care and treatment that the members of ACMS have made.

An important section of the book will be the Legacy Chapter, which will

focus on the Pittsburgh medical com-munity in 2016 and provide an opportu-nity for current practitioners to include their own medical career histories. The chapter will fund publication of the book and provide an opportunity for those participating to make the book a part of their own medical legacy for future family members to enjoy.

If you would like to know more about this project or have ideas or suggestions for the book itself, contact publisher John Compton or ACMS Executive Director Jack Krah, (412) 321-5030.

Pennsylvania Geriatrics Society sets fall program

The Pennsylvania Geriatrics Society – Western Division (PAGS-WD) will host their annual fall program Thurs-day, Nov. 1, at the University Club, 123 University Place, Pittsburgh. Regis-tration and reception begins at 6 p.m., followed by the business meeting. The program is scheduled to begin at 7 p.m. and is open to members and non-members, with a nominal registra-tion fee for guests.

This year’s presentation, “Natural Evolution of Telemedicine for Care of the Elderly,” features a panel presen-tation that will review the background and evidence of telemedicine as a way to address the challenges of geriatrics. Discussion also will include outlining new applications in telemedicine and the value and role of telemedicine as an effective tool for physicians and health care systems in the care of elderly patients.

Moderated by Namita Ahuja, MD, senior medical director, Medicare and Geriatric Programs, UPMC Health Plan, clinical assistant professor, Divi-sion of Geriatric Medicine, University of

Pittsburgh, the stellar guest panel includes: Jack Cahalane, PhD, MPH, chief, General Adult Service Line, Western Psychiatric Institute and Clinic, UPMC Health System; Steven Handler, MD, PhD, CMD, associate professor, University of Pittsburgh School of Medicine, Division of Geriatric Medicine and Department of Bio-medical Informatics, chief medical infor-matics officer, UPMC Community Provider Services; and Andrew Watson, MD, MLitt, FACS, chief medical information officer, International and Commercial Services, medical director, UPMC Telemedicine, medical director, Center for Connected Medicine.

The society gratefully acknowledges support for the program from Curavi Health and Presbyterian SeniorCare Network. Registration and program details will be posted on the society website at www.pagswd.org, with members receiving notification via email and mail. For further information, or to become a member of the soci-ety, please contact Nadine Popovich, administrator, at [email protected] or (412) 321-5030.

Dr. Cahalane

Dr. Handler

Dr. Watson

www.acms.org

Allegheny County Medical Society


iN mEmoriam

Philip P. Ripepi, MD, FACS, 82, of Bethel Park, died Sunday, August 7, 2016.

Dr. Ripepi graduated in medicine from the University of Pittsburgh, served his internship at Mercy Hospital and served residencies at Mercy and Memorial Hospital in New York.

He mentored hundreds of surgical residents and support-ed thousands of aspiring physicians. He innovated intraop-erative use of the soft-tissue laser, and was the first entre-preneur in Pennsylvania to open a free-standing outpatient surgery center.

Dr. Ripepi retired as a captain of the U.S. Army Re-serves.

Surviving are his wife of 55 years, Josephine Macri Ripepi; siblings Dr. Anthony (Ellie), Frances (John) Bazzano, Kay (Stanley) Valenti, Lauretta (Charles) Legeza, Dominic, Vincent (Gay) Macri and James (Jane) Macri; children Drs. Mark and Ursula Sangimino, Dr. Antonio and Michelle Ripe-pi, Dr. Vincent and Jodi Ripepi, Robert and Benedetta Quinn and Philip and Dr. Sarah Ripepi; grandchildren Julianne, Joseph, Victoria, Marissa, Meggie, Vincie, Nick, Robby, Claudia, Philip, Sophia, Sam, Lillie, Luke, Natalie, Andrew, Tony, Christian, John, Mark and Eric; and nieces, nephews,

godchildren, cousins and friends.Services were held Friday, August 12, in St. Germaine

Church, Bethel Park. ***

Anthony R. Haradin, MD, of Pittsburgh, died Friday, August 26, 2016.

Dr. Haradin graduated in medicine from the University of Pittsburgh Medical School; served his internship at Presby-terian-University Hospital; and served residencies at Pres-byterian-University, Western Reserve Hospital and Strong Memorial Hospital in Rochester, N.Y.

He was assistant professor of medicine at the Universi-ty of Pittsburgh for more than 45 years and served on the staffs of Presbyterian Hospital; St. Clair Hospital; St. Marga-ret’s Hospital; Jefferson Hospital; and Washington Hospital. At the time of his death, he was serving as co-chair of the Cancer Committee and coordinator of the Cancer Confer-ence at St. Clair Hospital.

Surviving are his wife of 56 years, Roberta; sons Ray (Nancy Lilja) and David (Leslie Borstad); grandson Alexan-der Taj Haradin; and brother Francis.

Services were held Monday, August 29, in St. Bernard Church, Pittsburgh.

ACMS member receives NMA Scroll of Merit honorAt the National Medical Association

2016 Annual Convention and Scientific Assembly in the Los Angeles Conven-tion Center July 30, 2016, William Sim-mons, MD, was named as one of four winners of the National Medical Associa-tion’s highest honor for Merit. This honor was followed by a “Special Congres-sional Commendation of Recognition” of the fact that Dr. Williams received the “Scroll of Merit” from

the NMA. Dr. Simmons is visiting associate professor at the University of Pittsburgh School of Medicine.

Local physician retires after 59 yearsGeorge McCollum, MD, 87, has retired after 59 years of

service as a family practitioner. Dr. McCollum, in practice since 1955, had been prac-

ticing in Beltzhoover since 1957. Over the years, he had worked at several hospitals, had a private practice and made house calls. He estimated he had more than 10,000 patient files in his small office in Beltzhoover, a house in which he lived at the beginning of his career.

Dr. Simmons

activitiEs & accoladEs

Allegheny County MediCAl SoCietyLeadership and Advocacy for Patients and Physicians


WelcomingNicole F. Vélez, MDDermatologic Surgery/Mohs Surgery Dr. Vélez is a board-certified dermatologist and fellowship-trained Mohs surgeon. She specializes in procedural dermatology and particularly in the management and treatment of skin cancer and facial reconstruction. She performs Mohs micrographic surgery, a specialized procedure that has the highest cure rate for skin cancer, as well as excisional surgery of benign and malignant tumors, and nail surgery. She also offers a variety of cosmetic dermatology services.

She graduated cum laude and Alpha Omega Alpha from the University of Pittsburgh School of Medicine. She completed a combined internal medicine and dermatology residency at Harvard Medical School in Boston, Mass.; followed by a fellowship in Mohs micrographic surgery, nail surgery and cosmetic dermatology in East Greenwich, Rhode Island. She is board-certified by the American Board of Dermatology and the American Board of Internal Medicine.

Dr. Vélez has published over 20 peer-reviewed journal articles and lectured both nationally and internationally on skin cancer. She is a fellow of the American Academy of Dermatology and a member of the American Society of Dermatologic Surgeons, the American College of Mohs Surgeons, and the Pennsylvania Academy of Dermatology. She has medical staff privileges at Allegheny General Hospital.

As always, new patients are welcome. Most major insurances are accepted.

Ad Size: 7.5x9.75

For an appointment, please call

AGH Dermatology

Allegheny General Hospital East Wing, 3rd Floor 320 East North Avenue Pittsburgh, PA 15212

412.359.3376AHN.org


alliaNcE NEws

A NEW KIND of Pennsylvania Medical Society Alliance

Annual Meeting in Hershey Oct. 22-23: Facts and Fun Donna Rovito, Leadership

Make sure to put October 22-23 on your calendar – that’s the word from the recent PMSA Board Mini-Retreat – at which the big topic of conversation was our upcoming Annu-al Meeting in Hershey, Pa.

The format will be shaken up a little to allow for more time to network with Alliance members from throughout the state, learn about the AMA Alliance’s extensive new Opioid Abuse Awareness Project (think SAVE and Hands are Not for Hitting) and get tips on how to enhance and improve our own medical marriages.

Installation of PMSA President Kathleen Hall will take place at lunch Saturday, followed by an “educational” event focused on the important question of how best to pair CHOCOLATE with wine! To make it all even more fun, family members of PAMED delegates will be invited to join us!

Of course, we’ll be setting up and checking out the AMES Silent Auction (please start thinking about your county’s or personal contribution!), attending the PAMED President’s Inaugural Dinner, giving out our AMES Fund Scholarships to a group of amazing Pennsylvania medical students and, of course, shopping! There was EVEN talk of expanding the traditional boutique to a “wellness room” by adding a mas-sage therapist for quick back, shoulder and foot massages, along with other services – does anyone like that idea? We’d love to hear from you! ([email protected])

Oh, we’ll do all the usual neat stuff, too – PMSA busi-ness, installation of the 2016-17 board and officers, hearing

from AMA Alliance and PAMED leadership and more. Watch for your Call to Convention in the mail to register

for this awesome event; for the latest information, be sure to Like our Pennsylvania Medical Society Alliance Facebook page! (https://www.facebook.com/Pennsylvania-Medical-So-ciety-Alliance-181967453022/)

MARK E. THOMPSON, MD, BENEFACTOR, ADVOCATE, SPONSOR in SUPPORT of ALLIANCE

Dr. Thompson’s June 2016 Bulletin cover photo of the American eagle family entitled “Proud Parents” demon-strates the strong sense of family the Thompsons exhibit for each other and beyond. In 1999-2000, Dr. Thompson and his sister, Janet, established and benevolently funded the Thompson Award as a memorial tribute to their parents, the late Ewing Thompson Jr., MD, and Mrs. Ruth D. Thompson, revered members of ACMS and ACMS Alliance.

The Thompson Award is presented in recognition of dedication to family, for work in service to community, and for service to ACMSA. We are profoundly proud of those ACMSA among us who have been recognized with presen-tation of the Thompson Award. The honorees embody all that the Thompson family imagined in the recipients of the Award they created for the ACMS Alliance.

The late parents of Mark and Janet surely must be very proud indeed! We were delighted to see Dr. Thompson at the Annual Meeting in May, and look forward to the pleasure of his company with his sister, Janet, at our Holiday Cham-pagne Brunch Dec. 4 at Edgewood Country Club.

Content and text by Kathleen Jennings Reshmi

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.


I would like to nominate (please print):

Nominee Information:

Address:

City, State, Zip:

Name:

Submitted by:

Address:

City, State, Zip:

Phone:

Email:

Nominations must be received by Wednesday, October 12, 2016.

Please attach a letter explaining why you are nominating this individual. You may include a brief history of the individual, letters of support, or up to 5 pages of supporting information. Please use one form for each nomination.

Four Under FortyEarly Career Physician Leadership Award

For physicians under 40 or within the first 5 years of practice following completion of residency or fellowship

This award recognizes four ACMS member physicians who have demonstrated leadership in advocacy, community service, education, patient care or research in the greater Allegheny community.

Nominations can be submitted online at:

www.acms.org/4Under40

Allegheny County MediCAl SoCiety FoundAtion

Awards will be presented at the ACMS Foundation Gala March 4, 2017.


The growth of online physician rating sites is causing a lot of physicians to feel like they’re losing control of

their reputations. When seeing negative comments online, it’s natural for professionals to want to respond

immediately to defend their reputations. But is that always the best course of action? In this special report,

NORCAL’s Risk Management experts discuss the pros and cons of responding to negative online comments

and lay out three steps to developing a plan of action for responding to online comments.

3 Steps To Responding

To Negative Online Comments

SPECIAL

REPORT


Responding to the Challenge of Online Ratings

With the growth of social media and online marketing outlets, physicians are experiencing a not-so-new phenomenon—bad publicity—but in a new medium. There are many online sites that allow patients to rate their physicians and leave narratives about their experiences, and the number is growing. Today, for example, 80% of Ob/Gyns and 60% of surgeons have more than five online ratings, while just four years ago only one in six had any online ratings.1 New websites allow people to rate, review, or leave comments about their doctors, operating in much the same way as online services that help people find the best hotels or avoid plumbers who overcharge.2

As these websites are increasing in popularity, so is the significance of their ratings. And while the ratings are generally positive, some patients are using these sites to make serious and repetitive attacks on providers’ reputations and competency. As a result, physicians may feel personally under attack, and some have claimed that the comments negatively affect them emotionally and financially. When these attacks occur, physicians may naturally want to go into a defensive mode in order to preserve their reputations, but they must still always maintain compliance with HIPAA and other privacy laws. Furthermore, if physicians respond immediately and impulsively, they may do more harm than good.

While this new reality may seem daunting, with a deliberate, reasoned approach, physicians can not only respond to negative online comments appropriately, but also enhance patient satisfaction by identifying and addressing any underlying issues that may have led to them.

“”

She did not listen to my concerns and did not answer my questions. While I was sitting in her office, she

took two phone calls and on one, scheduled a presentation for her practice by a drug rep.

I am getting my records and getting another doctor.

Considering Legal Action? Think Twice.

When physicians have attempted to use the legal system to stop online harassment, the courts have generally been less than accommodating to them. The following case demonstrates the courts’ attitude toward physicians’ attempts to protect their reputations.

Case Study: This case involved a neurologist who filed a lawsuit against the son of a former patient claiming defamation. The judge dismissed the case and stated, “The court does not find defamatory meaning but rather a sometimes emotional discussion of the issues.” The case was widely publicized through newspaper, internet and television media outlets, and it resulted in a negative impact on the physician’s practice.

If you’re considering suing a reviewer, there are many potential issues you need to be aware of to avoid pitfalls and counter-suits. Consult with your attorney as soon as possible before taking any steps in that direction.


NORCAL Mutual Risk Management Insight— 3 Steps to Responding to Negative Online Comments Because online reviews can affect your practice—both positively and negatively—the issue certainly warrants a plan of action. Developing one can help prepare you for when you become the target of negative online comments and help you avoid an emotional response in favor of a more measured one. These steps can also help improve your online ratings, mitigate the effects of negative online comments and guide your response to negative ratings before you ever face a crisis.

Remember: Always maintain compliance with HIPAA and other privacy laws. Do not reference patient information, the medical record or other protected information in public forums.

01 Be Proactive: Develop a digital and social media plan for your practice. To proactively build your online reputation, consider monitoring online comments and requesting reviews

from patients. Also, creating your own practice website and social media presence can help you control your message. Also consider the information and suggestions in this article to develop guidelines for responding to online reviews. Other helpful tools include office surveys and patient complaint processes to help you understand and address the needs and concerns of your patients.

02 Don’t Panic: Objectively assess the situation that led to the comments. Avoid an emotional, off-the-cuff response. Review the medical record for potential issues, but

never reference the medical record in your response. If there are significant issues, contact your professional liability insurance carrier and inform a representative about the situation. If the issue directly affects patient care and you therefore have interactions with the patient, document all communication and follow-up in the medical record.

03 Maintain Professionalism: Keep your tone professional and put the patient’s needs first. If you decide to respond, remember your response becomes part of your online reputation.

Follow group practice guidelines if you’re part of a group practice. Always maintain compliance with privacy laws and don’t directly or personally attack the individual posting the comment. Attempt to move the discussion to a private forum with a response like, “I’m sorry you had this experience. I’d like to discuss it with you. Please contact my office.”

THE IMPACT OF ONLINE RATINGS

88% of reviews on physician rating sites were positive3

6% of reviews on physician rating sites were negative3

6% of reviews on physician rating sites were neutral3

RATINGS AWARENESS AND ACTIONS RATINGS TONE

88%

6%6%

40% consider physician rating sites ‘somewhat important’ when choosing a physician4

37% avoided a physician with bad ratings4

35% selected a physician based on good ratings4


Copyright ©2015 NORCAL Mutual Insurance Company. All rights reserved. This document may not be reproduced or distributed without express written consent from NORCAL Mutual Insurance Company.

This report is presented as a courtesy by NORCAL Mutual Insurance Company. Our Risk Management Specialists are always ready to help policyholders with risk issues and to support practice changes that lower risk and improve patient safety.

About NORCAL Mutual

NORCAL Mutual Insurance Company is a policyholder-owned and physician directed medical professional liability insurance carrier that provides protection to physicians, health care extenders, medical groups, hospitals, community clinics and allied health care facilities across the nation.

NORCALMUTUAL.COM

References

1. Avondet, B. “All online physician ratings are not created equal.” KevinMD.com. October 30, 2014. Available at: http://www.kevinmd.com/blog/2014/10/online-physician-ratings-created-equal.html (accessed 5/11/15).

2. Roan, S. “The rating room.” L.A. Times. May 19, 2008.

3. Lagu, T; Hannon, NS; Rothberg, MB; Lindenauer, PK. “Patients’ evaluations of health care providers in the era of social networking: an analysis of physician-rating websites.” Journal of General Internal Medicine. 2009;25(9):942-946.

4. Hanauer, DA; Zheng, K; Singer, DC; Gebremariam, A; Davis, MM. “Public Awareness, Perception, and Use of Online Physician Rating Sites.” JAMA. 2014;311(7):734-735. doi:10.1001/jama.2013.283194. Available at: http://jama.jamanetwork.com/article.aspx?articleid=1829975 (accessed 5/12/15).


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.

You can also check out the NEW Allegheny County Medical Society Insurance Exchange, a convenient and secure online portal where you can find competitively priced insurance coverage for all your needs, including a wide variety of medical and dental plans.

The New World of Health Care is complicated.

Are You Prepared?

To learn more, contact USI Affinity today!

Call 800.327.1550, or visit the ACMS Insurance Exchange at www.usiaffinityex.com/acms


matEria mEdica

IntroductionHyperkalemia is a potentially lethal

electrolyte abnormality that can lead to life-threatening cardiac arrhythmias and increased mortality. Traditional treatment of hyperkalemia begins with stabilizing the cardiac membrane, mov-ing potassium intracellularly and finally, removing the excess potassium from the body. In patients with severe chron-ic kidney disease, the ability to excrete potassium is further compromised.

Patients at the highest risk for developing hyperkalemia include those with heart failure, diabetes, stage 3 or greater chronic kidney disease (CKD), or a combination of these disease states. Medication treatment of these disease states typically includes renin-angiotensin-aldosterone system inhibitors, which may further increase a patient’s risk for developing acute and chronic hyperkalemia. This risk often forces providers to either discon-tinue or use sub-therapeutic doses of these drugs, which have been shown to decrease mortality in these patient populations.

Patiromer (Veltassa®)Until 2015, sodium polystyrene

sulfonate (Kayexalate®) was the only FDA-approved drug to treat hyperkale-mia. Patiromer (Veltassa®) is a cation exchange polymer that contains a calcium-sorbitol counter ion. Patiromer

increases fecal excretion of potassium through the exchange of calcium ions and subsequent binding of potassi-um in the gastrointestinal tract.1 This binding results in the reduction of the concentration of free potassium in the gastrointestinal lumen, leading to a reduction in serum potassium levels. Patiromer should not be used in the emergency treatment of acute life-threatening hyperkalemia due to its delayed onset of action.

Sodium polystyrene sulfonate is a cation-exchange resin that uses sodium ions to exert its mechanism of action in the large intestine.2 Due to the use of the sodium ions, sodium poly-styrene sulfonate should not be used in patients who cannot tolerate even a small rise in sodium levels, such as patients with severe heart failure. Patiromer uses calcium ions to exert its mechanism of action in the gastrointes-tinal lumen. Patiromer is not systemi-cally absorbed and is excreted in the feces. No incidents of hypercalcemia have been reported with patiromer use in clinical trials.

Patiromer has a black box warning for binding to other oral medications.1 This may decrease absorption and re-duce the effectiveness of other medica-tions. Other oral medications should be administered at least six hours before or six hours after patiromer. Patiromer is available as 8.4, 16.8 and 25.2 gram packets. The average wholesale price for 30 packets of any strength of pati-romer is $714.

The most commonly reported

adverse effects of patiromer use are mild to moderate constipation, hypo-magnesaemia and hypokalemia. No life-threatening arrhythmias due to hypomagnesaemia or hypokalemia developed in patients who participated in patiromer clinical trials.1

Clinical trial summariesThe safety and efficacy of RLY5016

(patiromer) was evaluated in a pro-spective randomized double-blind pilot study (n =105) in patients at risk for developing hyperkalemia, receiving standard heart failure treatment and initiating spironolactone therapy.3 Patients were given patiromer or placebo for four weeks. The difference in serum potassium levels between the treatment and placebo groups at the end of four weeks was –0.45mEq/L (p<0.001). The patiromer group also had a significantly lower incidence of hyperkalemia (7.3 percent vs. 24.5 per-cent) and a greater number of patients on spironalctone 50mg/day (91 percent vs. 74 percent). The most commonly reported adverse effects were mild or moderate gastrointestinal adverse effects. There were no treatment-relat-ed serious adverse effects. Patiromer was relatively well-tolerated in patients with heart failure and allowed a greater percent of patients to be maintained on spironolactone 50mg/day.

AMETHYST-DN, a phase 2 random-ized clinical trial, was conducted to es-tablish starting doses of patiromer for

Patiromer (Veltassa®): A new option for treating hyperkalemia

alaina Koval

Continued on Page 344


matEria mEdica

a phase 3 study and evaluate the long-term safety and efficacy of patiromer in patients receiving an ACE inhibitor, ARB, or both, with hyperkalemia, diabetes and CKD (creatinine clear-ance 15-60mL/min/1.73m2).4 The study consisted of a four-week run-in phase, an eight-week treatment phase, a long-term maintenance phase for up to 44 weeks, and a post-treatment follow-up period of up to four weeks. Three hundred and six patients were stratified by baseline serum potassium into the categories of mild or moderate hyper-kalemia. These patients were further randomized to three different dosage regimens for each classification. The mean daily doses of patiromer from week four through eight were 19.6g/day in patients with mild hyperkalemia and 28g/day in patients with moderate hyperkalemia. Patiromer significantly decreased serum potassium levels across all dose groups through week four. These significant reductions and low incidence of reported hypokalemia in the 8.4g/day and 16.8g/day groups directed the selection committee to choose these as the starting doses for a phase 3 study. Over the 52-week study period, hypomagnesaemia, con-

stipation and diarrhea were the most commonly reported treatment-related adverse effects.4

The OPAL-HK phase 3 clinical trial had two phases, a four-week, sin-gle-group, single-blind initial treatment phase and an eight-week, placebo-con-trolled, randomized withdrawal phase.5

All patients had CKD, were receiving renin-angiotensin-aldosterone system inhibitors and had serum potassium levels between 5.1 and 6.4mmol/L. At the end of the initial four-week phase, 76 percent of 237 patients had reached the target serum potassium level of 3.8 to 5.0mmol/L. One hundred and seven patients were then enrolled in the fol-low-up phase and randomly assigned to either continue patiromer or start placebo for eight weeks. In the place-bo-treated group, a reoccurrence of hyperkalemia (> 5.5mmol/L) occurred in 60 percent of patients compared with a reoccurrence of 15 percent in the patiromer group through week eight. Adverse effects reported throughout OPAL-HK were similar to those report-ed in the AMETHYST-DN study.5

SummaryUntil now, sodium polystyrene sul-

fonate has been the only available oral therapy to treat hyperkalemia. The FDA

approval of patiromer (Veltassa®) pro-vides another agent to assist clinicians in the management of patients with chronic hyperkalemia. Treatment with patiromer has been limited primarily to small scale clinical trials. There has not been a head-to-head clinical trial comparing sodium polystyrene sulfon-ate to patiromer; so how it compares in safety and efficacy remains to be determined. However, clinical trials have demonstrated that patiromer is generally well-tolerated with only mild side effects. This may allow prescribers to better optimize doses of renin-angio-tensin-aldosterone system inhibitors or other agents which can cause hyper-kalemia in patients with chronic kidney disease, diabetes, or heart failure.

At the time of this writing, Ms. Koval, a PharmD candidate at Duquense University Mylan School of Pharmacy, was on a clinical rota-tion in the Center for Pharmaceutical Care at Allegheny General Hospital. For any questions concerning this article, please contact Tucker Freedy, PharmD, BCPS, at the Allegheny Health Network, Allegheny General Hospital, Center for Pharmaceutical Care, Pittsburgh, Pa. (412) 359-3192, or email [email protected].

From Page 343

References1. Veltassa® [package insert]. Redwood City, CA: Relypsa, Inc.; 10/2015.2. Kayexalate® [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC.; 04/2009.3. Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ; PEARL-HF Investigators. Evaluation of the efficacy and safety

of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J 2011;32(7):820-828.

4. Bakris, GL, Pitt, B, Weir, MR et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA 2015; 314: 151–161.

5. Weir MR, Bakris GL, Bushinsky DA, et al; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiv-ing RAAS inhibitors. N Engl J Med 2015;372(3):211-221.


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sPEcial rEPort

Michael Osnard, a dual MD/Master of Public Health student at the

University of Pittsburgh, believes that we have reached a tipping point in health care history. With changes in delivery and policy that reward care coordination and quality outcomes, organizations increasingly embrace new tools for positive change – tools that he and 30 other multidisciplinary health students who participated in the Jewish Healthcare Foundation’s (JHF) 2016 Patient Safety Fellowship are ready to wield.

“The Patient Safety Fellowship provided us with strategic ways to reach our goals,” says Osnard, who also participated in JHF’s 2016 summer internship program. “It’s inspiring to know that change can happen. This is a crucial time to make our voices heard.”

During the summer, health students from eight local universities – repre-senting disciplines including medicine, nursing, pharmacy, health care policy and management, public health, occu-pational therapy and bioengineering – learned JHF’s Lean-based Perfecting Patient CareSM (PPC) quality improve-ment method, applied their new knowl-edge and skills in real-world settings and benefited from the mentorship of the seasoned quality and safety cham-pions who were honored as winners of the 2016 Fine Awards for Teamwork Excellence in Health Care.

In a partnership between JHF and The Fine Foundation, the Fine Awards were established in 2008 to recognize and reward teams that demonstrate innovative, exceptional performance around patient safety and quality im-provement within their organizations.

Milton Fine, an acclaimed business-man and philanthropist, was inspired to create the awards after discover-

ing that key tenets of success in the corporate sector – including innovation, collaboration and customer service – are just as important in health care, but aren’t often championed. He and his wife, Sheila, guide The Fine Founda-tion, a family foundation which sup-ports high-impact projects related to science and medicine, arts and culture, and/or the enrichment of the Pittsburgh region. Ms. Fine also founded Leading Education and Awareness for Depres-sion (LEAD) Pittsburgh.

For the first time in 2016, the Fine Award winners served as dedicated mentors for the Patient Safety Fellows. Combining the two programs created a model that promotes health care excellence from generation to genera-tion, career development and a culture of safety – the sort of culture needed to address the estimated 250,000 pre-ventable deaths from medical errors in the United States each year, according to a recent study in the BMJ (formerly

Fine Foundation, JHF promote excellence in patient safety, health care quality

jewish healthCaRe FounDation

Photo PRovided

The 2016 Patient Safety Fellowship featured 31 fellows from eight local universities, representing the entire spectrum of health care.


sPEcial rEPort

called the British Medical Journal). In partnership with Fine Award

winners, the Fellows applied PPC methodology to analyze successful methods and look for opportunities to further increase quality, efficiency and safety. The Fellows examined isola-tion precaution protocol for intensive care unit (ICU) patients at Allegheny Valley Hospital; a Clostridium difficile reduction project at Excela Health; supportive housing and services for HIV-positive individuals at The Open Door, Inc.; and care coordination and patient engagement strategies at UPMC Shadyside’s surgical ICU. Then, the Fellows launched quality improve-ment projects of their own.

“The Fine Award winners, who have already attained a very high level of performance, invited our Patient Safety Fellows into their organizations to identify further opportunities for improvement,” says JHF President and CEO Karen Wolk Feinstein, PhD. “The lesson? Those who do the best are also the ones who are most excited about getting even better.”

Aparna Gupta, a Doctor of Nursing Practice student at Chatham University, notes that concepts learned during the Fellowship – including A3 problem-solv-ing, observation, the rules of work redesign and data management – can have an organizational ripple effect.

“In health care, you’re either moving

forward or backward,” Gupta says. “Small tests of change, and small wins, can lead to larger and sustained progress.”

UPMC Shadyside Surgical ICU Director Staci Mamula, RN, MSN, CCRN, was part of a team that won a Fine Award for reducing facial pres-sure ulcers in orally intubated patients. Serving as a mentor to two groups of Fellows was equally rewarding.

“This experience re-energized me about why we do quality improvement,” Mamula says. “The young people in the Patient Safety Fellowship, repre-senting so many disciplines, are the future of health care. We know it’s in good hands.”


lEgal rEPort

Act 16, the Pennsylvania Medical Marijuana Act, (the “Act”) was

signed into law by Gov. Tom Wolf April 17, 2016, with an effective date of May 17, 2016. The Act provides patients in need with access to approved forms of medical marijuana, while focusing on its safe and effective delivery. The Pennsylvania Department of Health has created the Office of Medical Mar-ijuana that will implement and oversee the state’s medical marijuana program (the “Program”).

The Program is being established for patients who suffer from one of 17 specific serious medical conditions. The patient must be a resident of Pennsylvania and meet the require-ments for certification as set forth under the Act. The enumerated med-ical conditions cover a wide range of diagnoses including, but not limited to: cancer, autism, Parkinson’s dis-ease, multiple sclerosis, Huntington’s disease, Crohn’s disease, epilepsy, post-traumatic stress disorder, HIV and AIDS.

While the Act is now currently in effect, the process that growers/pro-cessors and dispensaries of medical marijuana must partake in is highly regulated and will likely take between one to two years before policies and procedures resulting in the growth and sale of medical marijuana are fully operational. In the interim, caretakers of minor patients under the age of 18 who suffer from one of the 17 serious

medical conditions are now able to receive medical marijuana in approved forms, from outside the Common-wealth, pursuant to recently adopted safe harbor regulations.

In order to obtain a Safe Harbor Letter (the “Letter”), a request must be made to the Department of Health, which includes the completion of an application process. An applicant can be a parent or legal guardian of a minor, spouse of a minor, or a care-giver who has been approved as a caregiver by the Department of Health. One step in the application process for obtaining the Letter requires that a physician sign a form that the mi-nor has a serious medical condition covered under the Act (the “Physician Certification”). However, under federal law, marijuana is still classified as a Schedule I controlled substance with no currently accepted medical use, a lack of accepted safety for use un-der medical supervision, and a high potential for abuse. This classification can lead to criminal charges and fines. In order to assist physicians in helping minor patients acquire medical marijua-na, while minimizing the criminal risks associated with a Schedule I drug, the

Department of Health has made it clear that a signed Physician Certification will not serve as a prescription for medical marijuana, but rather only a statement that the minor has a serious medical condition as defined under the Act.

Once the Letter has been received by the Department of Health, it is valid until May 17, 2018, unless it becomes invalid before such date under spec-ified circumstances provided for in regulations. Reasons why a Letter may become invalid include: death of the minor, the minor turning 18, a change in physician, the applicant being unable to carry out their responsibilities, the minor no longer having a serious medical condition or no longer benefit-ing from the use of medical marijuana, or the minor establishes residency in another state. Letters also can be denied, suspended or revoked for rea-sons including: evidence of a history of drug abuse, criminal offenses relating to the sale or possession of controlled substances, crimes of moral turpitude, or providing false information.

While the current Safe Harbor guidelines provide for the above stated requirements, the Act further provides that physicians must review the Pre-scription Drug Monitoring Program to evaluate the patient’s history with any controlled substances prior to issuing a Physician Certification. The patient also must be under the physician’s con-tinuing care for the condition and likely to receive a palliative or therapeutic

Medical marijuana and a physician’s role

BaRRy nelson, esq.


lEgal rEPort

benefit from it.Physicians are not required to

participate in the medical marijuana program, however those who wish to do so must comply with certain re-quirements. In order to be able to issue Physician Certifications, a physician must apply to be on the registry with the Department of Health. Registration includes providing documentation of credentials and experience in order to treat patients with one of the serious medical conditions, completion of a four-hour approved training program, and having and maintaining a valid, un-expired, unsuspended and unrevoked medical license.

Participating physicians are tasked with certain ongoing monitoring and reporting requirements related to the status of the patient’s serious medical condition and the continuing value of the patient’s course of treatment. In addition, there are a number of re-strictions on participating physicians that they must be aware of, including prohibitions on: holding interests in medical marijuana organizations

(direct or economic), advertising as a practitioner who can certify patients to receive medical marijuana, and issuing a Physician Certification for them-selves, family members or household members of the physician.

Initiatives of, or in conjunction with, the Pennsylvania Department of Health are in progress, with a strong focus on the input of physicians regarding the medical marijuana program. Some recently announced programs, such as a new Medical Marijuana Physician Workgroup comprised of participants of health systems throughout Pennsylva-nia, as well as surveys that have been dispatched and some that will be forth-coming from the Department of Health, are being used to assist in developing temporary regulations for physicians. The goal of these regulations is to pro-vide physicians access and exposure to the knowledge necessary to be able to appropriately determine whether medical marijuana could be a benefit to qualified patients, without being dismis-sive or hesitant.

As the regulations continue to be

generated and implemented, physi-cians need to remain informed as the landscape of the medical marijuana program in Pennsylvania will be evolv-ing. Physicians must understand the requirements of the Act and the appli-cable Department of Health regulations as well as the permissible scope of their duties under the Program, while still recognizing that marijuana remains a Schedule I controlled substance under Federal law, with criminal and civil penalties attached to its posses-sion and use, including violations of the Controlled Substance, Drug, Device and Cosmetic Act.

Mr. Nelson is a shareholder in Tuck-er Arensberg’s Business and Finance Division and chair of the Medical Marijuana Practice Group. Mr. Nelson concentrates his practice in the areas of commercial finance and corporate transactional law representing a wide variety of business clients. He can be reached at (412) 594-3901 or [email protected].

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