Allegheny County Medical Society Bulletin March 2015 Legal considerations of telemedicine National Healthcare Decisions Day Narrow network contracting Care is Your Business, Change is Ours The 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. hh-law.com Business • Employment • Estates and Trusts • Health Care Litigation • Oil and Gas • Public Finance • Real Estate Allegheny County Medical Society Bulletin March 2015 / Vol. 105 No. 3 Articles Perspectives Departments Materia Medica .................... 116 Editorial ................................. 94 Society News ....................... 111 Long-awaited revisions to pregnancy, lactation labeling have arrived Karen Fancher, PharmD, BCOP Spring awakening Deval (Reshma) Paranjpe, MD, FACS Narrow network contracting: Are we finally poised to make progress? Michael A. Cassidy, Esq. Amelia A. Paré, MD, FACS Editorial ................................. 96 Legal Report ....................... 120 All things are possible Editorial ................................. 98 Legal considerations of telemedicine Special Report ................... 123 Timothy G. Lesaca, MD Updates from the ACHD Perspective ......................... 100 Kristen Mertz, MD, MPH 3D digital mammography Special Report ................... 124 (Digital Breast Tomosynthesis) National Healthcare Decisions Day Marcela Böhm-Vélez, MD, FACR, Marian Kemp, RN FSRU, FAIUM Judith S. Black, MD, MHA • 2015 Clinical Update in Geriatric Medicine • HELP conference • ACMS to offer leadership training program • American College of Surgeons • Pittsburgh OB/GYN Society • Spring Regional Training Programs announced In Memoriam ....................... 112 • Michael J. Shaughnessy, MD ACMS Alliance News .......... 114 Letter to the Editor ............. 115 Perspective ......................... 102 Classifieds ........................ 130 Special Report ................... 126 The short happy life of a medical Meaningful Use attestation is complete, now breathe a sigh of relief – or can you? Pennsylvania Medical Society’s Practice Support Team Special Report ................... 128 Coping with malpractice litigation The Foundation of the Pennsylvania Medical Society specialty: Pain Medicine, 1985-? Stephen M. Thomas, MD, MBA Perspective ......................... 106 Care of the underserved Ed Kelly, MD On the cover Jenny Lake and the Grand Tetons by Kimberly Hennon, MD Dr. Hennon specializes in emergency medicine. Bulletin Affiliated with Pennsylvania Medical Society and American Medical Association 2015 Executive Committee and Board of Directors President John P. Williams President-elect Lawrence R. John Vice President David J. Deitrick Secretary Robert C. Cicco Treasurer Adele L. Towers Board Chair Kevin O. Garrett DIRECTORS 2015 Vijay K. Bahl Patricia L. Bononi M. Sabina Daroski Sharon L. Goldstein Todd M. Hertzberg William K. Johnjulio Karl R. Olsen 2016 David L. Blinn Robert W. Bragdon Thomas B. Campbell Douglas F. Clough Jason J. Lamb 2017 Peter G. Ellis David A. Logan Jan W. Madison Matthew B. Straka Angela M. Stupi PEER REVIEW BOARD 2015 Paul W. Dishart G. Alan Yeasted 2016 John G. Guehl Rajiv R. Varma 2017 Donald B. Middleton Ralph Schmeltz PAMED DISTRICT TRUSTEE John F. Delaney Jr. COMMITTEES Awards Donald B. Middleton Bylaws David J. Deitrick Communications Amelia A. Paré Finance Karl R. Olsen Gala Patricia Bononi Adele L. Towers Nominating Rajiv R. Varma Occupational Medicine Teresa Silvaggio Primary Care Lawrence R. John ADMINISTRATIVE STAFF Executive Director John G. Krah ([email protected]) Assistant to the Director Dorothy S. Hostovich ([email protected]) Bookkeeper Susan L. Brown ([email protected]) Communications Bulletin Managing Editor Meagan Welling ([email protected]) Assistant Executive Director, Membership/Information Services James D. Ireland ([email protected]) Manager Dianne K. Meister ([email protected]) Field Representative Nadine M. Popovich ([email protected]) Medical Editor Deval (Reshma) Paranjpe ([email protected]) Associate Editors Michael Best ([email protected]) Charles Horton, MD ([email protected]) Robert H. Howland ([email protected])) Timothy Lesaca ([email protected]) Scott Miller ([email protected]) Amelia A. Paré ([email protected]) Gregory B. Patrick ([email protected]) Brahma N. Sharma ([email protected]) Managing Editor Meagan K. Welling ([email protected]) ACMS ALLIANCE President Kathleen Reshmi First Vice President Patty Barnett Second Vice President Joyce Orr Recording Secretary Justina Purpura Corresponding Secretary Doris Delserone Treasurer Josephine Martinez Assistant Treasurer Sandra Da Costa www.acms.org Leadership and Advocacy for Patients and Physicians 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. The Bulletin of the Allegheny County Medical Society welcomes contributions from readers, physicians, medical students, members of allied professions, spouses, etc. Items may be letters, informal clinical reports, editorials, or articles. Contributions are received with the understanding that they are not under simultaneous consideration by another publication. Issued the third Saturday of each month. Deadline for submission of copy is the SECOND Monday preceding publication date. Periodical postage paid at Pittsburgh, PA. Bulletin of the Allegheny County Medical Society reserves the right to edit all reader contributions for brevity, clarity and length as well as to reject any subject material submitted. The opinions expressed in the Editorials and other opinion pieces are those of the writer and do not necessarily reflect the official policy of the Allegheny County Medical Society, the institution with which the author is affiliated, or the opinion of the Editorial Board. 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Malachy Whalen, 412.281.4050 Member Resources [email protected] BMI Charts, Healthy Lifestyle Posters, Where-to-Turn cards What does Allegheny County Medical Society ACMS 412.321.5030 membership [email protected] do for me? Editorial O Spring awakening n a random weekday in March, the first rush of spring came over us all. Gone were the -6ºF temperatures, replaced by a blissful, blushing, angelic 55ºF day complete with sunshine and warm breezes. The songbirds came back with a vengeance, and even though the temperature dropped and the clouds closed in the next day, they refused to stop their chorusing. The relentless optimism of the song sparrow and the indigo bunting is infectious, delightful and happily obnoxious. Winter? Did winter ever exist? I don’t think so, do you? Is it not amazing? We labor under the gray and icy doldrums of what seems the longest and coldest Pittsburgh winter in an age, and think it will never end. Or if it does, that horrid weather will cede only to a drizzly and miserable spring. And yet at the first sign of sunlight and blue sky and warmth, we all to some degree become raving spring maniacs, filled with irrepressible glee. Admit it, under your cool and proper façades, some part of you wished you had a convertible JUST so you could put the top down that day (and those of you who do … perhaps you did; I salute you). But this is the way of the world. When you remove oppression, those who labored under it will suddenly emerge and thrive. Once the blanket of snow is gone, the little worms will come out, and the songbirds will feast upon them. Once the frosts are over, the flowers will emerge and bees will buzz among them in search of nectar. Once 94 Deval (Reshma) Paranjpe, MD, FACS the coyote moves on, the rabbits go forth and … well, they do what rabbits do best. Once Communism falls, entrepreneurs rise immediately to become capitalists. Once war is declared over, the arts and culture can emerge and celebrate. Once a stranglehold of taxation is relieved, people can spend more freely, and the economy can boom. (Once the health care wars in Pittsburgh are over, the rest of us can go back to practicing and receiving medical care with lighter hearts.) We are privileged to see a different sort of spring awakening, too – one that we can see in any season. Once you manage to remove pain and suffering and handicap from a patient’s life, you can see that person thrive in their everyday life, and return to the myriad of everyday joys and despairs that the healthy take for granted. You can see the boost in confidence if you’ve helped lessen someone’s joint pain by medicine or surgery to the point where they can do what they want to do – or even remember what they want to do. You can see the joy when you fix a knee or a hip and see someone walk, run, or dance. You can see it the first day after cataract surgery when someone takes off the patch and wants to hug you. And you can see it most of all when your patients forget they ever had a problem. Once the health care wars in Pittsburgh are over, the rest of us can go back to practicing and receiving medical care with lighter hearts. We are so privileged today to hear patients say, “Oh yes, I had a thyroid problem. But my doctor put me on medication and now I feel wonderful.” We are privileged to hear patients say to each other casually: “Oh, yes, I had heart valve surgery. I had a brain aneurysm repaired. I had a tumor removed. I had cancer, but now I’m in remission. I have HIV, but I’m living with it. I’m fine now. I’m fine now, but I have a scar. I’m fine now, and I can’t remember exactly what I had. I’m fine now. My doctor caught it. My specialist diagnosed it. I had a good surgeon.” Like it was child’s play. Like it was nothing. Fifty years ago, would we have heard these things? Would they have been around to blithely say these things afterwards – to each other, over coffee, or to the checkout clerk at the grocery store before driving home? For every thought of despair that you have – for every patient you suffer with or lose, God forbid – to cancer, to heart disease, to trauma or organ failure or sepsis or psychiatric disease – remember how many songbirds are out there who happily chant “I’m fine now” and go on with their daily lives. Even though they may have been through Bulletin / March 2015 Editorial a winter that you feared they might not make it through; even though they have weathered storms that 50 years ago they most assuredly could not have. The human spirit is optimistic, like the defiant songbird, like the tenacious daffodil, like the indefatigable grass that pokes its way through the frozen earth year after year. Medicine is inherently optimistic, otherwise we wouldn’t even try to go to work. Give the human spirit a day of hope and it gathers strength to sing. Give yourself a day of sunshine, however you can, and you will forget about the long winter that has just passed. Dr. Paranjpe is an ophthalmologist and medical editor of the ACMS Bulletin. She can be reached are reshma_ [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. Our multi-million-dollar, state-of-the-art healthcare facility. Every day, we provide healthcare to more families in their homes than just about anyone. Whether you’re recovering from surgery, disabled or just need a little help to maintain your independence, our trained, experienced caregivers will come to your house and take care of you. On a part-time, full-time or live-in basis. We’re Interim HealthCare®, and we provide healthcare for the people you love. Give us a call. Ruby Marcocelli 1789 S Braddock Ave. Pittsburgh, PA (412) 436-2200 Bulletin / March 2015 www.interimhealthcare.com 95 Executive Editorial Committee All things are possible D octors underestimate themselves and the power of the common good. March 31 is the date that the current Sustainable Growth Rate (SGR) patch is set to expire. There is little political will to fund a permanent fix. However, to underfund Medicare would be political suicide. What can a Pittsburgh physician do, and why? Contact your Federal legislators through capwiz.com. In Allegheny County, your representative is either Rep. Mike Doyle, (202) 225-2135, doyle.house.gov; Rep. Tim Murphy, (202) 225-2301, murphy.house.gov; or Rep. Keith Rothfus, (202) 225-2065, rothfus.house.gov. Our Federal senators are Sen. Bob Casey, (202) 2246324, casey.senate.gov; or Pat Toomey, (202) 224-4254, toomey.senate. gov. All are familiar with the SGR issue. If you would like to know more about the latest effort to repeal SGR, go to fixmedicarenow.org. The biggest questions for physicians are: Why should we get involved? Why should doctors work with legislators in order to pay their staff and utilities? Because the community re- Amelia A. ParÉ, MD, FACS lies on doctors for employment, health and to stand up for community health issues in our society. On Feb. 22, 2012, President Obama and former first lady Laura Bush broke ground on the National Museum of African American History and Culture on the National Mall. Instead of ignoring a part of our history that does not represent our values, we as Americans study the past to create a better future. In President Lincoln’s time, he was quick to realize that he must first emancipate the 3,185 slaves within the District of Columbia on April 16, 1862, before the Emancipation Proclamation of 1863. We as physicians must know that to get formal SGR restructuring, we must first ask for a patch and create a political environment that values health care in our community. We create that at the ballot box but also when we are in our communities, speaking with our patients and neighbors. We have studied medicine; we are disciplined; now we must bring that caring to our communities by advocacy for the basic human rights that make us Americans. With hard work, all things are possible. Pittsburgh has helped create one of the most earth-shattering medical achievements of the decade: the Salk vaccine. Pittsburgh is a leader in industry that the rest of the world has looked to in the fields of technology, energy production in numerous forms, steel and coal production. Pittsburghers are quiet but cannot be underestimated. I implore you to contact your legislators to patch the SGR while we determine how Medicare will evolve in the future. Dr. Paré is a plastic surgeon and is associate editor of the ACMS Bulletin. She can be reached at [email protected] org. 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. Allegheny County Medical Society Leadership and Advocacy for Patients and Physicians 96 Bulletin / March 2015 APPLICATION FOR MEMBERSHIP Preferred Method of Contact: Mail: _____ (Office or Home) E-mail: _____ Fax: _____ Full Name(please print): Last First Middle Office: Area Code & Phone Number Home: Area Code & Phone Number E-Mail: Office Fax: Area Code & Phone Number Sex: Date of Birth: Primary Specialty: License: Secondary Specialty PA No.: Date Issued: Present Type of Practice: Employed by Hospital/Health System Employed by Physician(s) Employed by Industry or Government Owner of Physician Practice Independent Contractor Other (Specify) ______________________ Practicing full-time Practicing part-time Retired from practice Currently not in practice Other (Specify) ______________________ Practice Name: Employment Status: Present Hospital Appointments: Dates: Within the last 5 years, have you been convicted of a felony crime? Yes Within the last 5 years, has your license to practice medicine in any jurisdiction been Yes tes: No. If yes, please provide full information. limited, suspended or revoked? No. If yes, please provide full information. Within the last 5 years, have you been the subject of any disciplinary action by any medical organization or hospital staff? Yes No. If yes, please provide full information. If elected to membership, I agree to conduct myself professionally and personally according to the principles of medical ethics and to be governed by the Constitution and Bylaws of the Allegheny County Medical Society and the Pennsylvania Medical Society. I hereby release, and hold harmless from any liability or loss, the Allegheny County Medical Society, the Pennsylvania Medical Society, their officers, agents, employees, and members, for acts performed in good faith and without malice in connection with evaluating my application and my credentials and qualifications and hereby release from any liability any and all individuals and organizations, who, in good faith and without malice, provide information to the above named organizations, or to their authorized representatives, concerning my professional competence, ethical conduct, character and other qualifications for membership. I also authorize the above named organizations, in the consideration of my application, to make inquiry of any of my references and institutions by which I have been employed or extended privileges, as to my qualifications. I further authorize any of the above persons or institutions to forward any and all information their records may contain and agree to hold them harmless for any actions by me for their acts. Date: Bulletin / March 2015 Signature: 97 Editorial F Legal considerations of telemedicine rom a legal perspective, the rapid growth of telemedicine raises unique issues regarding the application of traditional medical-legal principles in a new health care delivery system. For the purpose of this article, I would like to review the challenges that telemedicine creates for state medical licensure, malpractice insurance and malpractice liability risk management. As telemedicine grows in popularity, it is important for physicians to be aware of state-by-state medical licensing requirements. The general rule regarding remotely treating patients is that the physician must have a full and unrestricted license in the state where the treatment is being provided, or more specifically, where the patient is located. For example, a physician in North Dakota practicing telemedicine on a patient in Pittsburgh must be licensed to practice medicine in Pennsylvania. There are some exceptions to this general rule, the most important occurring when a state grants a physician a special license to provide telemedicine in that state. At the present time, there are nine state boards which provide telemedicine restricted licenses (Alabama, Louisiana, Minnesota, Montana, New Mexico, Ohio, Oregon, Tennessee and Texas). These limited licenses allow physicians to practice telemedicine across state lines without having to obtain a full state license where the 98 Timothy G. Lesaca, MD patient is located. These licenses are regulated by the state where the patient resides, and do not credential in-person treatment. The state of Pennsylvania requires a physician to obtain a Pennsylvania state medical license to practice telemedicine on patients living in the state, and does not have specific regulations addressing the parameters of how to engage the practice of medicine over the Internet. Forty-six of the 50 states have outof-state consultation exceptions. These exceptions allow physicians to consult on out-of-state patients under limited circumstances. Alabama, Indiana, Mississippi, Oklahoma and South Dakota expanded their definitions to include diagnostic or treatment services provided through electronic means or communications. For the physician considering employment in telemedicine, another important consideration is the fact that most malpractice insurers do not cover telemedicine-related liability. That circumstance might change in Pennsylvania in the future, as there is proposed legislation in the Pennsylvania House of Representatives (HB 491) which would mandate private insurance coverage for telemedicine liability. The bill is currently in committee. Most medical malpractice insurance covers only in-person encounters within the state in which the doctor practices and is licensed. Doctors who provide telemedicine services to patients outside the state in which they are licensed can be exposed to uninsured claims if state law requires that the doctor be licensed in the state where the patient resides; therefore, obligations of malpractice insurance carriers must be examined on a stateto-state basis. Because of the expansion of telemedicine, there is a growing market of medical malpractice plans that are specific for such practice. The American Telemedicine Association recently created a partnership with an international insurance brokerage and risk consulting service focusing specifically on telemedicine. Such insurance products could insure physicians treating patients who reside anywhere in the United States, with policy premiums based upon the amount of time worked in each state. Such plans also would address some of the other unique liabilities of telemedicine, such as technology errors, cyberliability and patient data privacy. Despite the lack of uniformity in state licensure policy and malpractice Bulletin / March 2015 Editorial insurance coverage, there is a general consensus that the care provided via telemedicine will need to meet the same standard of care provided in person. Central to the establishment of standard of care has historically been the nature of the physician-patient relationship. Some liability issues will center around a debate of whether it is possible to establish such a relationship in the absence of an actual physical encounter, and if it is in fact possible to establish a physician-patient relationship through remote connections alone. The American Medical Association’s (AMA) Council on Medical Service recently adopted a position on this issue by stating that prior to delivering services via telemedicine, a valid physician-patient relationship must be established, through at minimum a face-to face examination, which could occur in person or virtually through real-time audio and video technology. Although this position is helpful for liability-wary doctors, it does not address the question of whether an in-person physical examination also is a necessary component of that relationship prior to prescribing treatments such as medication. There are many other unresolved issues regarding telemedicine liability, such as whether telemedicine should impose higher standard of care requirements and additional certification and technology training, should an in-person physical exam be required prior to the use of telemedicine services, and can a provider’s failure to use available telemedicine technology be considered malpractice. There is very little information on the extent of malpractice liability and telemedicine, and the outcomes of the few relevant cases have been sealed. Nonetheless, as telemedicine becomes more widespread, medical liability issues will undoubtedly increase. Since the dynamics of such potential cases have yet to be worked through, these future cases will be uniquely complicated. Unfortunately, there will be no shortage of malpractice attorneys seeking “first to market” advantage by advertising for potential cases to litigate. As telemedicine becomes more prevalent, it most likely will foster its own unique standard of care. Unfortunately, that standard has not yet been established, leaving the future both bright and unclear. Dr. Lesaca is a psychiatrist specializing in children and adolescents and is associate editor of the ACMS Bulletin. He can be reached at [email protected] hotmail.com. 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. 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. Bulletin / March 2015 99 Perspective 3D digital mammography (Digital Breast Tomosynthesis) T hree-dimensional (3D) digital mammography (Digital Breast Tomosynthesis or DBT) has revolutionized breast imaging. The limitations of 2D digital mammography in patients with dense fibroglandular tissue have been described, and sensitivity may be as low as 40 percent for detection of breast cancer. In addition, these patients may require further work up including additional imaging (i.e., mammographic views, ultrasound, MRI) to evaluate asymmetries or architectural distortions causing anxiety. Multiple studies have shown compelling clinical data that 3D mammography technology can provide significant improvements on the most frequently cited limitations of conventional 2D mammography. A large study published in the Journal of the American Medical Association (JAMA) June 25, 2014, “Breast Cancer Screening using 3D digital mammography in combination with 2D digital mammography,” was conducted at five leading academic hospitals. Eight community-based sites evaluated more than 450,000 mammography exams. Researchers found that 3D mammography technology finds significantly more (41 percent) invasive breast cancers than 2D mammography, while simultaneously providing a significant (15 percent) decrease in false positives. This allows that invasive cancers may be detected earlier, when treatments are more effective and less 100 Marcela Böhm-VÉlez, MD, FACR, FSRU, FAIUM traumatic for patients and not as costly to the health care system. Also, fewer patients will be called back for additional tests, thus reducing the burden of surveillance for referring physicians and preventing undue anxiety for patients. Various studies have confirmed that 3D mammograms can increase detection of earlier stage cancers in all types of breast densities, including the fatty breast. Tomosynthesis takes a series of low dose X-ray exposures at different angles. The individual images are then reconstructed into a series of high resolution, 1 mm-thick slices which can be displayed on a workstation. The 3D dataset reduces detection challenges associated with overlapping structures in the breast, which is the primary drawback of conventional 2D mammography. One of the controversies to the use of tomosynthesis, especially for screening, is the increased radiation dose exposure. The average dose of glandular radiation from the many low-dose projections taken during a single acquisition of 3D mammography is roughly the same as that from 2D mammography. Therefore, using both 2D and 3D doubles the radiation dose to the breast, even though it is still below the acceptable limits of the Mammography Quality Standards Act (MQSA). However, this concern may be obviated using the FDA-approved technology of a synthesized view obtained from the 3D acquisition, eliminating need for the addition of 2D exposures. In view of the significant increase cost of the unit, service contract, storage of data, time for the radiologist to interpret the more than 1,200 images, the Centers for Medicare and Medicaid Services (CMS) released new codes and values for DBT for 2015. The three new Current Procedural Terminology (CPT®) codes were created as requested by the American College of Radiology (ACR), the American Roentgen Ray Society, and the Radiological Society of North America, and the value approved by the Relative Value Scale Update Committee (RUC). The article published this January in the Journal of ClinicoEconomics and Outcomes Research suggests that there is an economic benefit for payers and patients when using tomosynthesis to screen women for breast cancer. Commercial insurers may save at least $28 for every patient screened with DBT compared to using only 2D mammography. However, we are currently waiting to see if the insurers will pay for this new technology. Bulletin / March 2015 Perspective 2D Craniocaudal views of the left breast 3D Increased Cancer Detection: The 2D mammogram of the left breast in a woman with scattered breast tissue was normal; however, the 3D image revealed a small spiculated mass (circled; invasive ductal carcinoma) in the upper outer quadrant of the left breast, allowing treatment to begin earlier. Dr. Böhm-Vélez is a radiologist and president of Weinstein Imaging Associates, a private practice focused on women’s imaging with offices in Shadyside, South Hills and North Hills. She also is chair of the Pennsylvania Radiological Society (PRS) Breast Imaging Committee. She can be reached at [email protected] gmail.com. 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. Bulletin / March 2015 References 1. Skaane P, Bandos AI, Gullien R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. 2. Zuley ML, Guo B, Catullo VJ, Chough DM et al. Comparison of Two-dimensional Synthesized Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images. Radiology. 2014 Jun; 271(3):664-71. 3. Skaane P, Bandos AI, Eben EB, et al. TwoView Digital Breast Tomosynthesis Screening with Synthetically Reconstructed Projection Images: Comparison with Digital Breast Tomosynthesis with Full-Field Digital Mammographic Images, Radiology. 2014 Jun;271(3):655-63. 4. Gur D, Zuley ML, Anello MI, et al. Dose reduction in digital breast tomosynthesis (DBT) screening using synthetically reconstructed projection images: an observer performance study. Acad Radiol. 2012 Feb;19(2):166-71. 5. Ciatto S, Houssami N, Bernardi D, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol 2013; 14: 583–89. 6. Durand MA, Haas BM, Yao X, et al. Early Clinical Experience with Digital Breast Tomosynthesis for Screening Mammography. Radiology, 2015 Jan, 274: 85–92. 7. Haas BM, Kalra V, Geisel J et al. Comparison of Tomosynthesis Plus Digital Mammography and Digital Mammography Alone for Breast Cancer Screening, Radiology, 2013, Dec, 269: 694–700. 8. Bonafede MM, Kalra VB, Miller JD, Fajardo LL .Value analysis of digital breast tomosynthesis for breast cancer screening in a commercially-insured US population. Journal of ClinicoEconomics and Outcomes Research 2015 Jan: 7: 53—63. 9. Silva E, How to Code Tomosynthesis, JACR 2015 Jan :12: 15. 101 Perspective The short happy life of a medical specialty: Pain Medicine, 1985-? I n the Hemingway story, “The Short Happy Life of Francis Macomber,” the protagonist’s life was neither exceedingly short nor especially happy.1 He found himself betrayed by those who should have protected him, facing his deficiencies, overcoming his cowardice, only to have his newfound bravery lead him into harm’s way and seal his fate. Much like Macomber, my chosen specialty of Pain Medicine faces a looming transformation, as the business into which it has grown tilts counter to the interests of those concerned: its practitioners, consumers and payers. Some may misinterpret my apparently premature eulogy as an attack upon Pain Medicine. It is not. All medical practice is among the most gracious human endeavors imaginable. Well done, it is beautiful, lithe, benevolent and noble. Relieving suffering is a compassionate goal. Note, I have carefully avoided its vulgar name: “Pain Management.” That we let this term define the field is reflective of the problem. “As you think, so shall you be.” In focusing on “management,” too much of our attention has been on our actions, rather than our understanding. This emphasis on activity over thoughtfulness plagues the entirety of the medical services industry. (Again, with deliberation I shun using the currently popular euphemism: “health care.”) One can hardly blame us when the reward structure of the industry so heavily favors doing anything over al- 102 Chronic opioid therapy in practically unbounded doses for patients with chronic non-malignant pain was a bad idea, based upon lowing the miracle of healing to happen unproven, unsupportable without us. One can hardly impugn premises. us, as patients assail us with their Stephen M. Thomas, MD, MBA plaintive cries: “Doc, you’ve got to do something!” It is not our fault that they and we dread most that often nothing should be done. One can hardly condemn us when our own voices fill our ears with the idea that what we do is “Pain Management,” distinct from the medical practice of caring for those who suffer pain. The three pillars upon which the business of Pain Management has been built are crumbling – in part from their rickety construction; in part from the unreasonable weight we have asked them to bear. Those disintegrating pillars are: liberal chronic opioid prescribing, injection therapy and implantable analgesic devices (spinal cord stimulators and intrathecal pumps). I took part in kindling the U.S. prescription drug epidemic. I know that I don’t know how many of the patients to whom I liberally prescribed opioids following the 1996 APS/AAPM Consensus Statement2 abused them. I know that my underestimation of the addictive potential of chronic opioid therapy harmed some I meant to help. I am now keenly aware of the hubris of thinking that I knew what I was doing. Chronic opioid therapy in practically unbounded doses for patients with chronic non-malignant pain was a bad idea, based upon unproven, unsupportable premises. Among the weakest was that the patina-like cerebral cortex could override the drives of the mass of subcortical opioid-responsive tissue upon which it rests. With more than 12 million nonmedical users and 22,000 deaths per year,3 now we know. Prior to the 2012 cluster of patients with iatrogenic fungal infections secondary to contaminated compounded depot steroids,4 resulting in 44 deaths, we knew that 85 percent of back pain is nonspecific, that too many corticosteroids weaken the bones, that the pituitary-adrenal axis was not created to be suppressed. We knew that high-quality clinical data supporting more than brief symptomatic relief eluded us, despite all those steroids pumped by the gallon into all those spines. But memory held Continued on Page 104 Bulletin / March 2015 Formerly Prudential Preferred Realty Hidden Valley Priced at $2,000,000 MLS#1040685 Bulletin / March 2015 This 4 bedroom, 4 full and 2 half bath, mountain treasure is called “Still Waters”. We can share the owners story as it includes incredible details of the thought process, construction, materials, and amenities that were used to create this unique property. If you entertain, the kitchen is professional grade with both a caterer’s and butler’s pantry. If you love your vehicles there are 5 heated bays. If you love wine, the cellar holds 2,000 bottles. If you love the outdoors, you are in the heart of the Laurel Highlands. All showings will be escorted as the property is gated. Scan the QR code to see the Visual Tour highlighting the quality of craftsmanship and detail that this property offers. Architectural plans show approximately 10,000 square feet of living area. Plans and survey are in the office. Abe & Wags Wagner Amanda Knepper-Gelpi 800-419-7653 | [email protected] 103 Perspective addiction. The physics of electrical flow the anecdote of the patient who did so predicted that spinal cord stimulation would help those with neuropathic much better than we would have exextremity pain, unexpectedly benefiting pected. Her representation in memory axial pain complaints. Psychologic has loomed larger than warranted by consultation reveals nothing of the the facts. heart. The bewitching power of placebo Implantable analgesic devices, like inherent in our technologic “solutions” all medical therapies, are bounded by shadows the room; a shadow we would their indications. Those indications are much prefer to ignore. Still, “some narrower than we wish they were. The things work for some people some medical literature informs us that the time.” failure rate of these machines is much We are the first generation of higher (~40 percent) in the bodies physicians tasked with appreciating of people than in our imaginations.5 existential versus unconstructive Almost any spinal opioid dose is, by suffering as a therapeutic divide. In our definition, high-dose opioid analgesia paid hero quest, we risk doing great 6 (oral:spinal ratio 300:1), carrying with it physical, psychospiritual and fiscal all the caveats of that treatment except harm. In refusing our limitations, we From Page 102 References 1. Ernest Hemingway. “The Short Happy Life of Francis Macomber.” Cosmopolitan Magazine (1936): 30-33, 166-172. 2. “The Use of Opioids for the Treatment of Chronic Pain.” American Academy of Pain Medicine and the American Pain Society. 1997. http://opi.areastematicas.com/generalidades/OPIOIDES.DOLORCRONICO.pdf 3. “Policy Impact: Prescription Painkiller Overdoses.” Centers for Disease Control and Prevention, November 2011. http://www.cdc. gov/homeandrecreationalsafety/rxbrief/ 4. “Multistate Outbreak of Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy,” Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, October 19, 2012, http://www.cdc.gov/mmwr/preview/mmwrhtml/ mm6141a4.htm?s_cid=mm6141a4_w 5. Tracy Cameron, PhD, “Safety and stand confronted by the beast, grown more dangerous by its wounding. What path have we worn for those following – much about doing, but so little about being? “There is nothing so useless as doing efficiently that which should not be done at all.” -Drucker.7 Will we heed the gasping? Can we save the best of its life? Dr. Thomas is a pain medicine physician and CEO of SSEA, LLC. He 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. Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: a 20-Year Literature Review, J Neurosurg, no. 100 (2004): 254-267. 6. Scott M. Fishman, Jane C. Ballantyne, and James P. Rathmell. “Intrathecal Drug Delivery in the Management of Pain,” in Bonica’s Management of Pain, 4th ed. (Baltimore: Lippincott Williams & Wilkins, 2010). 7. Peter Drucker. The Essential Drucker (New York: HarperCollins Publishers, 2001). Make Your Billing Headaches Go Away 32131-KellAd-ACMSB-QtrCbw.indd 1 104 If you manage a medical practice, don’t lose sleep over billing issues. At the Kell Group, we take the worry out of the management of your revenue cycle. We make sure claims are correct, complete, submitted timely and paid appropriately. The Kell Group increases medical practice collection rates an average of 12 percent. That’s roughly $12,000 for every $100,000 of billing. We increase revenue through sound, thorough and consistent billing practices and processes. We help new practices establish robust billing systems, and we help established practices get the most out of their billing systems to achieve maximum revenues. Above all, we provide support to our clients with integrity, and with high levels of personalized service, acting as an extension of the medical practice team. 56 South 21st Street Pittsburgh, PA 15203-1930 (412) 381-5160 Fax: (412) 381-5162 We can help. Call us. www.kellgroup.com 12/18/13 10:48 AM Bulletin / March 2015 Welcoming Adeel Haq, MD Pain Management For an appointment, please call Dr. Haq is a board-certified pain management physician offering patients clinical expertise using interventional techniques, adjuvant therapy and medical management to manage chronic pain from a variety of disease processes. Wexford Pain Management Wexford Health + Wellness Pavilion 12311 Perry Highway Wexford, PA 15090 He received his medical degree from Saba University School of Medicine in Saba, Netherlands-Antilles, Dutch West Indies. He completed his emergency medicine residency at the University of Louisville in Louisville, Kentucky where he served as chief resident. He completed his pain management fellowship training at the University of Pittsburgh in its Department of Anesthesiology. He is certified by the American Board of Physical Medicine and Rehabilitation and the American Board of Emergency Medicine and is a Fellow of the American College of Emergency Physicians. 412.DOCTORS (362.8677) AHN.org Prior to joining the pain management program at the Wexford Health + Wellness Pavilion, Dr. Haq worked as an emergency medicine physician at Clark Memorial Hospital in Jeffersonville, Indiana, at UPMC Passavant Hospital in Wexford and at Heritage Valley Hospital in Sewickley. He also established a pain medicine practice and served as medical director of Heritage Valley Pain Management with offices in Sewickley and Beaver. Dr. Haq holds professional memberships with the American Society of Regional Anesthesia and Pain Medicine, the American Society of Interventional Pain Physicians and the American College of Emergency Physicians. As always, new patients are welcome. Most major insurances are accepted. Bulletin / March 2015 Ad Size: 7.55X9.75 105 Perspective Care of the underserved M ost of us seek a pathway when we have a medical problem that is covered by an insurance policy. Office visits, imaging studies, laboratory testing and hospital admissions/procedures are addressed by various means of coverage which one may purchase or is provided by his/her employer. Dental needs are readily obtained most often on a cash basis. Mental health issues can be handled through our insurance policy, although obtaining mental health services often can be quite challenging. I doubt that the majority of us are aware of the difficulties encountered when one in an underserved population attempts to navigate through the complexities of the health care system. For many, an emergency room becomes the first choice, perhaps because they were not aware of the options that are available. Dental problems are but one example. When someone is dealing with jaw pain often associated with an abscess, they may be seen in an emergency room where they are prescribed an antibiotic and analgesic with instructions to see their dentist. Most patients have no dental insurance and are loathe to spend cash for follow up. They often end up with a tooth that will need extracted. I will attempt to simplify the landscape so as to provide an awareness of how someone who does not have the ability to purchase an insurance policy can seek care. We are dealing with three categories of patients: the homeless, those eligible for welfare, and those who have an income making 106 Ed Kelly, MD them ineligible for welfare but who have no insurance. One may ask about what is available through the Affordable Care Act (ACA). What we are finding is that many who have entered the “marketplace” find that they are unable to afford the deductibles and co-pays which they may face. These are patients who are subject to a fine (for not having insurance) which they choose to accept because it turns out to be less than the costs that they may face with one of the options offered by the ACA. We are in the second year where one can enroll in one of the plans offered through the ACA, and at this time, 6 percent of the uninsured have purchased coverage. First, I think that we need to understand how someone is considered to be in a medically underserved area (MUA) or medically underserved population (MUP). In the Federal Register of Oct. 15, 1976, certain weighted values were defined to designate how an MUP or MUA is designated. A few of the statistics that are considered are the percentage of the population below the poverty level and percentage of the population over age 65. An MUA may be a whole county or group of contiguous counties in which residents have a shortage of personal health services. An MUP may include a group of persons who face economic, cultural or linguistic barriers to health care. Another designation is health professional shortage area (HSPA), where there is a shortage of medical, dental or mental health providers. These are simply guidelines which assist in establishing the need for considering centers for health care delivery in underserved populations. In these areas, a Federally Qualified Health Center (FQHC) or a Federally Qualified Health Center Look Alike can be established. The difference between the two is that the “Look Alike” does not have the same level of federal oversight as the FQHC. In addition, the FQHC Look Alike does not have liability coverage by the Federal Tort Claims Act (FTCA). Health care providers in these centers are salaried. Patients who seek care in these centers are asked to pay on a “sliding scale” basis. Dental care often is available in these centers. What is the FTCA? In 1945, a B-25 airplane struck the Empire State Building. The FTCA was written by Congress to permit private citizens to sue the United States in federal court for most torts. The FTCA constitutes limited waiver of sovereign immunity. The Health Insurance Portability and Accountability Act of 1996 extended eligibility for FTCA to volunteer health care professionals at qualifying free centers. Funds to support the program were appropriated in 2004, and the first free clinic volunteers were “deemed” eligible in 2005. A health care provider covered by the FTCA Bulletin / March 2015 Perspective is considered to be a public service worker. The health care provider who applies for coverage is protected by the Act only for the services rendered in the free center. An individual who alleges fault with their treatment rising to the level which they perceive to be malpractice may then file a grievance with the U.S. government but not against the individual. What does a provider have to do to be deemed eligible by the FTCA? The same credentials as one would submit to apply to a hospital staff are required. The data bank is queried. Any criminal records or disciplinary actions by health care systems are included. This information is submitted to the FTCA, and if the FTCA rules favorably, the health care provider is “deemed” eligible. Again, the person is covered by the FTCA only for care rendered at the health care center. The provider does not have to pay to be covered by the FTCA. FTCA coverage is renewed every two years assuming one’s record is “clean.” A red flag would exist should one have been involved in legal actions during those two years (malpractice, arrests). Most free health care centers, FQHC’s and FQHC Look Alikes also ask an individual for a criminal check and child abuse clearance. As you see, volunteering at a free center or working at a federally funded facility involves more than “knocking on the door” to be considered for a position. How is health care provided for the homeless, many of whom live on the streets, with occasional periods of shelter provided by incarceration or transient stays with relatives? The definition of homeless is quite complex, and more detail is available by going to the website of the U.S. Department of Housing and Urban Affairs. Among the homeless are some who arrived on the streets as a result of “bad choices,” for example college students or graduates who succumbed to the hazards of substance abuse. We must not forget that there also are homeless children. It is estimated that there are about 1.5 million homeless children nationally with the average age of 7 years. Most Continued on Page 108 Allegheny County Medical Society Member Benefits Plastic Surgeon Dennis J. Hurwitz, MD, is seeking a physician associate to share space and staff at his recently remodeled upscale Plastic Surgery Suite in the Western entrance to Oakland, Pittsburgh. Our clinic, certified operating room and medical spa are ideal for self-pay oriented doctors such as Plastic Surgeons, Concierge PCPs, Wellness PCPs, or Dermatologists. Centrally located and free parking available. Please call (412) 802-6100. Bulletin / March 2015 In-House Services • ACMS Foundation • Information Clearinghouse • Mailing List Service • Meeting/Conference Center • Membership Directory • Notary • Professional Announcements/Mailings • Referrals • Speaker’s Bureau 107 Perspective From Page 107 homeless children can expect to live in poverty all of their lives. (Hon. David Hickton, Summit II, Collaborations and Models Impacting Children and Youth Experiencing Homelessness, 4/8/2011) In Western Pennsylvania, there are close to 3,000 individuals who are considered homeless. Many have mental illness or problems with drugs and alcohol. A surprising number are veterans (inability to find employment begins the downward spiral). In Pittsburgh, Operation Safety Net, which was begun by Dr. Jim Withers in 1992, provides health care for the homeless. There are about 45 similar programs nationally and 95 programs globally. Obviously, there are many areas in the United States where health care for the homeless has not been established. Care for this population in Western Pennsylvania is funded by grants and private donations. If an individual wishes to not live on the streets, there are various “shelters” where they can apply to live but they are charged on a “sliding scale” basis. For many, a Social Security check is their only source of income, and often the challenge they face is establishing an address to which the check can be delivered. As mentioned above, homeless individuals often seek temporary residence with a relative, and this may be the address which they use for receipt of a check from Social Security. Pregnancy is one of the issues that exists on the streets, but statistics are not available for the number of children borne by homeless mothers. Expectant mothers may appear at various stages of gestation, and the goal is to establish prenatal care and encourage them to enter a regular schedule of appoint108 ments allowing the obstetrics department the opportunity to have a patient record. There are various options for infants borne by the homeless, one of which is foster homes. Bear in mind that many are delivered by mothers who have substance abuse problems or have had no prenatal care. There is a Street Medicine Institute which has met on an annual basis for 10 years, with the first symposium having been held in Pittsburgh. These meetings have been held at the locations of programs for the homeless both nationally and internationally. The institute funds a fellowship, and there are approximately 20 medical schools in the country which offer a street medicine elective. The purpose behind the elective is to allow students to see the portion of the population which has no access to organized medicine. Additionally, the Street Medicine Institute is consulting with communities throughout the United States to assist in developing new programs for care of the homeless in their locale. Housing has become a large part of the focus of Operation Safety Net, and over the past 11 years, approximately 12,000 homeless have been housed in apartments throughout Western Pennsylvania. (Personal communication with Dr. Jim Withers) Having a place to live affords the opportunity for the person to address hygiene and other matters that will allow them a more suitable appearance when they interview for employment. Finally, there are many health care centers in the United States that have been established by faith-based organizations or private groups which charge nothing and are staffed by volunteer nurses, physicians and dentists. These clinics are likely to be used by those whose income makes them ineligible for welfare but they have no insurance. Funding is provided by donations and grants. Perhaps I will focus on Volunteers in Medicine (VIM), of which there are 97 centers in 29 states (VIM Institute Alliance). These centers receive no government funding, and the volunteers are eligible to file for FTCA coverage. In order for one to receive care in one of these centers, they must first be interviewed for financial eligibility. This involves assessing their ineligibility for welfare, and their annual income is usually measured in relationship to the federal poverty level. The initial VIM center was established by a physician, Dr. Jack McConnell, in Hilton Head, S.C. His efforts evolved in the early 1990s with the challenge of: “What have you done for someone today?” Some of the hurdles which he had to face were volunteer licensure for the numbers of physicians who came to Hilton Head from other states, and funding for an entity that did not previously exist posed a bit of a challenge. VIM is the only national nonprofit dedicated to building a network of free primary health care clinics for the uninsured in local communities. Perhaps a better understanding of how Volunteers in Medicine evolved would come from reading Dr. McConnell’s book published in 1998, “Circle of Caring.” The prompting to establish Volunteers in Medicine came from an encounter which he had with a hitchhiker whom he picked up as he was returning from a round of golf. Many of the “free” health care centers throughout the nation establish relationships with health care systems in their locale. Through these avenues, Bulletin / March 2015 Perspective they are able to provide pharmacy services, laboratory studies and imaging, and they often will avail themselves of the “free care” programs which exist at many health care systems in the country. If, for instance, someone is in need of surgical consultation, they will be referred to a practice in the institution which treats patients for no charge. In the United States, there are health care needs for those with limited access to health care which are addressed by various means. The federal government offers those graduating students with burdensome debt the opportunity to practice at clinics in an underserved area for a period of time with loan repayment as part of their package. Scholarship opportunities exist where one commits to a period of time providing medical needs to an underserved area following completion of training. (National Health Service Corps) Indian Health Services (funded by the Public Health Service) have been established throughout the United States, but many have to face the problem of being understaffed. The challenge is to provide a salary compa- rable to what is available elsewhere. Those who travel abroad to volunteer their services are to be lauded. There are areas of need throughout the world with lack of personnel, equipment and facilities to address the multiplicity of complex health care issues which involve multiple specialties. They not only provide needs to patients who otherwise would have no opportunity for treatment of their problems (e.g., cleft palate, genito-urinary anomalies), but they also provide mentoring to physicians in many parts of the world to which they travel. While these efforts should be encouraged and continued, perhaps the above serves to point out that there are areas in the United States which similarly lack the facilities and expertise to address the needs of a population considered to be underserved. As was discussed previously in speaking of the homeless, there are many areas in our country where care for the “street people” is not available. Similarly, “gap” areas exist where patients rely on emergency rooms in their area for evaluation and treatment of nonurgent health care problems. What I hope to have done is to make us all aware that there are countless members of our population who do not enjoy the conveniences of health care that most of us do and perhaps we should occasionally ask ourselves: “What have you done for someone today?” Should you encounter a situation in your practice where the need arises to refer a patient for care elsewhere (e.g., individual no longer has insurance coverage), the Allegheny County Medical Society is available to provide information as to what options may be available. Many people are “displaced” or terminated from their employment, and navigating the health care system when they finally lack health insurance for them and the family may become as much of a challenge as looking for employment. Dr. Kelly is volunteer medical director of Catholic Charities Free Health Care Center. He can be reached at (412) 456-6910. Lead the Way for your HEALTH CARE TEAM Looking to advance your career? Want to hone your team-building skills? PAMED, in collaboration with the American Association for Physician Leadership(AAPL), has training options for individuals and groups. Questions? Contact Leslie Howell at (800) 228-7823, ext. 2624 or [email protected] www.pamedsoc.org/leadershipacademy Bulletin / March 2015 109 Is it a fun game? Or a form of brain injury rehabilitation that could score big for your patients? Fun and healing go hand-in-hand at The Children’s Institute. We offer a wide array of innovative therapies, including recreational, music, physical, occupational, speech/language, behavioral, adaptive sports, nutrition and more. And our experience is second to none. We are the only CARF-accredited pediatric Brain Injury Program in Pennsylvania and the ﬁrst organization in the nation to develop effective treatments for children and youth with traumatic brain injuries. To see how we are helping kids score big in the game of life, call 412.420.2400 or visit amazingkids.org. Squirrel Hill • Irwin • Wexford • Bridgeville 110 Bulletin / March 2015 Society News 2015 Clinical Update in Geriatric Medicine set The Clinical Update in Geriatric Medicine will be held March 26-28 at the Marriott City Center in Pittsburgh. This award-winning course has been a Dr. Studenski popular and respected resource for more than 22 years. It is jointly sponsored by the Pennsylvania Geriatrics Society – Western Division (PAGS-WD), University of Pittsburgh Dr. Inouye Institute on Aging, and University of Pittsburgh School of Medicine Center for Continuing Education in the Health Sciences and is co-sponsored by the Geriatric Education Center of Pennsylvania. The program is designed by course directors Drs. Shuja Hassan, Judith Black, and Neil Resnick, along with the PAGS-WD planning committee. Stephanie Studenski, MD, MPH, and Sharon K. Inouye, MD, MPH, are among the distinguished guest faculty for the three-day program. Dr. Studenski recently was appointed chief of the Longitudinal Studies Section in the Translational Gerontology Branch of National Institute on Aging’s (NIA) Intramural Research Program. In her role, she directs the Baltimore Longitudinal Study of Aging (BLSA), one of the nation’s longest and most prestigious studies of aging. Over her 30-year career, Dr. Studenski has conducted observational studies and clinical trials focusing on human aging and age-related disease, mainly Bulletin / March 2015 using biomechanical and neuroimaging techniques to evaluate risk factors and mechanisms of late-life disability. Prior to joining the NIA, Dr. Studenski was a professor of geriatrics in the department of Medicine at the University of Pittsburgh Medical Center (UPMC). Dr. Inouye is the director of the Aging Brain Center at the Institute for Aging Research, Hebrew SeniorLife in Boston, Mass. She holds the Milton and Shirley F. Levy Family Chair and is a professor of medicine at Harvard Medical School (Beth Israel Deaconess Medical Center). Dr. Inouye developed and validated the Confusion Assessment Method (CAM), the most widely used instrument for the identification of delirium. She conceptualized the multifactorial model for delirium, which focuses on identification of predisposing and precipitating factors for delirium. Rounding out the conference’s exceptional guest faculty are Sally L. Brooks, MD, and Barbara J. Messenger-Rapport, MD, PhD, FACP, CMD. Local expert faculty also will enhance the program and provide key evidence-based sessions. Conference credits include a maximum of 19.5 AMA PRA Category 1 credits™; with other health care professionals awarded 1.9 continuing education units (CEUs). An application for CME credit for AAFP has been filed with the American Academy of Family Physicians (determination of credit is pending); social work credits are offered (19.5 hours of social work); and nursing credits are a maximum of 19.5 contact hours. ACPE credits are available with 17.5 contact hours (the maximum amount of continuing education credit granted). Registration is now being accepted at https://ccehs.upmc.com/liveFormalCourses.jsf. For additional information, call (412) 647-8232 or email [email protected] Members of the PAGS-WD receive a discount when registering for the conference. To inquire about becoming a member or current membership status, contact Nadine Popovich at (412) 321-5035, ext. 110, or email [email protected] Apply for membership on the ACMS website at www.pagswd.org. 13th International HELP conference slated The national Hospital Elder Life Program (HELP) conference will be held in conjunction with the Clinical Update conference March 26-27. Designed Dr. Rubin by course directors Sharon Inouye, MD, MPH, Fred Rubin, MD, and Shin-Yi Lao, MPH, BSN, RN, this two-day international conference educates HELP teams regarding strategies for delirium prevention, using HELP to improve hospital-wide care of the elderly, and creating a climate of change. Expert clinicians and experienced members of the HELP sites will share evidence-based information and clinical insights on selected topics regarding the influence of HELP, delirium updates and the larger policy implications of care for the elderly. Updates on collaborative papers, expansion of the program and innovative site projects also will be presented. For more information, please contact Krystal Golacinski, UPMC Center Continued on Page 112 111 In Memoriam Michael J. Shaughnessy, MD, 76, of Fox Chapel, formerly of Forest Hills, died Sunday, February 22, 2015. Dr. Shaughnessy graduated in medicine from the University of Pittsburgh, served his internship at Mercy Hospital and served his residency at Mercy Hospital, Allegheny General Hospital, and the University Health Center. Specializing in urology and urologic surgery, Dr. Shaughnessy practiced at Suburban Urologic Associates at Forbes Regional Hospital, Jefferson Hospital, Braddock Hospital, Allegheny General Hospital and St. Francis Medical Center. Surviving are his wife, Carol J. Shaughnessy; children Maureen Block and Michael (Amy) Shaughnessy; grandchildren Nathaniel and Declan Block and Emma and Maeve Shaughnessy; and sister Eileen Connelly. Services were held in St. Scholastica Church, Aspinwall. Society News From Page 111 for Continuing Education in the Health Sciences, at (412) 647-7050 or via email [email protected] ACMS to offer leadership training program Save the date! On Thursday, March 26, 2015, Allegheny County Medical Society (ACMS) will once again partner with Ally Training & Development to offer Cure for the Common Leader, an immersive leadership course that gives physicians and managers the soft skills they need to build and lead teams in health care. The research-based curriculum gives participants interactive, application-based training in employee engagement and motivation, giving performance feedback, cultivating purpose and communication. The course will be taught by Joe Mull, president of Ally Training & Development and author of “Cure for the Common Leader: What Physicians & Managers Must Do to Engage & Inspire Healthcare Teams.” Mr. Mull is the former head of learning and development for physician services at UPMC. Ally Training & Development currently provides leadership and man112 agement training support to a variety of regional health care professionals. This is the second consecutive year ACMS has offered a leadership training program to members. The program is open to and appropriate for physicians and managers. ACMS members and partners will receive discounted registration. Visit www.acms.org/pm for additional details and registration information. their Most Interesting Cases of 2014. Make plans now to attend the meeting May 11 at the Rivers Casino. Contact Dianne Meister, (412) 321-5030, ext. 107, Dr. Chen or [email protected] org, to be added to the mailing list if you are not a member of the chapter. American College of Surgeons Pittsburgh OB/GYN Society The Southwestern Pennsylvania Chapter of the American College of Surgeons (ACS) held an event Nov. 3, 2014, at the Omni William Penn hotel in Pittsburgh. Pauline Chen, MD, FACS, was the keynote speaker. Dr. Chen presented “Choosing between Technology and Palliation,” speaking on end-of-life care and what that means for physicians who consider death a personal failure. Dr. Chen is the author of “Final Exam: A Surgeon’s Reflections on Mortality,” and is a New York Times columnist. The Southwestern Pennyslvania Chapter of the ACS will once again host residents from the regions’ surgical programs when they present The Pittsburgh Obstetrics/Gynecology Society with Smith & Nephew will hold a dinner meeting May 12 at Eddie Merlot’s. Linda Bradley, MD, from the Cleveland Clinic, will speak on the topic of Hysteroscopic Morcellation. Contact Dianne Meister at (412) 321-5030, ext. 107, or [email protected] acms.org, to receive an invitation. Spring Regional Training Programs announced Western Psychiatric Institute is announcing the schedule of 2015 Spring Regional Training Programs. The full schedule is available at http://www. wpic.pitt.edu/oerp. Contact Joanne Slappo, MD, at (412) 204-9077 or [email protected] for more information. Bulletin / March 2015 The New World of Health Care is complicated. Are You Prepared? 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. To learn more, contact USI Affinity today! Call 800.327.1550, or visit the ACMS Insurance Exchange at www.usiaffinityex.com/acms Bulletin / March 2015 113 Alliance News Leadership – ACMS Alliance A survey to determine leadership for the coming year of the Allegheny County Medical Society Alliance (ACMSA) has been sent to current officers and committee chairmen. Present terms of office expire May 31, 2015. During winter and spring Board Meetings, review of survey replies will help determine proposals for appointment to the Governing Board for Alliance year 2015-16. Look for the final Leadership Report/Slate as an enclosure with your invitation to Annual Meeting and Luncheon. Expect invitations with enclosure to be mailed to all ACMSA members in late April. ACMSA’S GOVERNING BOARD LEADERSHIP REPORT SINCE JANUARY 10, 2012, REPLACES THE NOMINATING COMMITTEE REPORT During the Business Meeting segment of Annual Luncheon May 19, 2015, the Leadership Report/Slate will be presented to the General Membership. Nominations/recommendations from the floor are encouraged and welcome. In the instance of conflict, the vote shall be by ballot. The General Membership will vote by voice, to approve the Slate. The vote will confirm as elected the Slate of appointments to the Governing Board. Join us in leadership, standing committees, service projects or on event committees. Volunteers are valued at any level of commitment. Opportunities for this Alliance year and 2015-16 still available! Call us at (412) 321-5030. Annual Meeting and Luncheon SAVE THE DATE TUESDAY, MAY 19, 2015 The Pittsburgh Golf Club, Schenley Park Friends and Guests Welcome! Look for Formal Invitations in April ALLIANCE MEMBERSHIP AREAS OF OPPORTUNITY Please check to Indicate your area of interest. We’ll be in touch to welcome you with enthusiasm We will mentor you into activities you’ve selected. We will acknowledge your support of events and projects. Thanks from all of Alliance for your reply! 412-321-5030 □ Community Service □ Public Health Education □ Event Planning □ Communication □ Fundraising □ Leadership □ Unable to actively participate, but will support Alliance events and projects to benefit Health Education Projects, Community Service Organizations, Disaster Relief and ACMS Foundation 114 Winter work for spring things is well underway by ACMSA Event Chair Mrs. Alan J. Barnett. Mrs. Barnett is calling for committee members to formalize and finalize details of Annual Meeting and Luncheon. This always festive luncheon is a great opportunity for new members to be visible and involved. Do join us in any of many elements of party planning. Partner with us on invitation mailing, program design and print, centerpieces, menu selections, acquisition of donations for door prizes, donor items for baskets and raffle items. Be in touch with Mrs. Barnett by phone listing in ACMSA Directory/Yearbook. New members please call Alliance at (412) 321-5030. Mrs. Barnett will be in touch with committee volunteers and plans a Committee Meeting soon. Content and text by Kathleen Jennings Reshmi 2015-2016 MEMBERSHIP APPLICATION ALLEGHENY COUNTY MEDICAL SOCIETY ALLIANCE Level Member Resident County $ 35.00 $ 20.00 State $ 55.00 $ 55.00 National $ 40.00 $ 40.00 Total $130.00 $115.00 Last Name ______________________________________ First Name ______________________________________ M.I. _____ Address: ________________________________________ City ____________________ State _____ Zip __________ Phone: (Area Code) _______________________________ Fax: (Area Code) _________________________________ Email: __________________________________________ Please Indicate: __ New Member __ Reinstated __ Resident __ Spouse __ Other Make Checks Payable to: Allegheny County Medical Society Alliance 713 Ridge Avenue, Pittsburgh, PA 15212-6098 Bulletin / March 2015 Letter to the Editor March 5, 2015 Dear Editor: The recent public debate in controversy regarding the benefit of childhood vaccinations primarily against measles infection (MMR vaccine) reawakened the discussions of the relative merits (and perceived risks) of the human papillomavirus (HPV) cancer prevention vaccine. We feel obligated to address a few points for the medical community in Western PA. First, we note that successful development of various anti-viral and anti-bacterial vaccines has unquestionably been one of the major scientific and public health breakthroughs in the past 100 years or more. Indeed until widespread vaccinations in the vast majority of our youth, leading to herd immunity to essentially eradicate previously lethal or morbid infectious diseases, many children often did not survive past adolescence. Now such an event is extraordinarily rare, if not unheard of in an adequately vaccinated child. The most recent addition to the pediatrician’s armamentium is vaccination against high risk HPV (types 6, 11, 16 & 18). The latter two types are responsible for 75 percent of cervical cancer and essentially 100 percent of a rapidly rising number of cancers located in the tonsils and base tongue otherwise known as Head and Neck cancers. While there are effective screening programs such as the Pap smear for cervical cancer, there is no known screening procedure for HPV-associated head and neck cancer. These devastating diseases affect the throat and can lead to difficulties swallowing, can rapidly spread to the lymph nodes in the neck, and if not treated with intensive combinations of surgery, Bulletin / March 2015 radiation and/or chemotherapy, are life-threatening. Both of these HPV-associated cancers and others that occur elsewhere in anogenital tract, appear entirely preventable with the current regime of vaccinations (three vaccinations over 6 months). Indeed, the vaccines were FDA approved in 2010 for both girls and boys between the ages of 11-24, but uptake is only 30 percent in the United States (and lower in boys). The vaccine is extremely safe. Various vaccines have been spuriously associated in the popular press with some negative side effects, which has been resoundingly disproven by every expert group that has analyzed the claims. The data are clear that childhood vaccinations are not associated with neurologic disease or ADD, which is increasingly diagnosed whether one received the vaccine or not. Thus for a theoretical side effect which is unproven, to be balanced against a documented and well-known lethal series of viral infections, the choice to obtain vaccinations (MMR, HPV, and others) is clear. We have begun witnessing the concerned parents as measles outbreaks are seen, and we continue to see more and more HPV-associated head and neck cancers receiving expensive and toxic cancer treatments that scar the patient for life. This is entirely preventable in return for extraordinarily low risk. We write today, not because we believe the medical community has not heard these arguments before, but rather to remind and to exhort our colleagues to assume our expected leadership role as teachers and advocates. All pediatricians, and indeed all health care professionals, need to be more articulate, more convincing, and to advocate for vaccinations on the childhood schedule for which they have been recommended. If a pediatrician is uncomfortable with this advocacy, we would suggest reaching out to obtain further information to clarify any concerns that may exist, since we believe the data are exceedingly clear in favor of strongly recommending these vaccinations for our children, both boys and girls. Indeed the uptake rate for HPV vaccination is only 10 percent in boys and 30 percent in girls in the United States, and Western Pennsylvania is no different. We must do a better job to achieve more than 90 percent vaccinations of this preventable infection, as nearly all European countries and Australia have done successfully. The time is now to counteract the misinformation and advocate on behalf of our patients, armed with the data that is so clear. Sincerely yours, Robert L Ferris, MD, PhD, FACS UPMC Chair in Oncologic Head and Neck Surgery Professor and Chief, Division of Head and Neck Surgery Associate Director for Translational Research Co-Leader, Cancer Immunology Program University of Pittsburgh Cancer Institute Jonas T. Johnson, MD, FACS The Eugene N. Myers Chair Distinguished Service Professor Chairman, Department of Otolaryngology University of Pittsburgh School of Medicine 115 Materia Medica Long-awaited revisions to pregnancy, lactation labeling have arrived Karen Fancher, PharmD, BCOP A n estimated 6.5 million women become pregnant each year in the United States, and about one in every 10 women of childbearing age is pregnant each year.1 Approximately 64 percent of women use at least one prescription drug during pregnancy, with an average of three prescription drugs used throughout a pregnancy.2 Management of maternal disease states during pregnancy and lactation are critical for both maternal and fetal health. The Food and Drug Administration (FDA) recently has reconfigured prescription drug labeling to include clearer information on whether a drug is safe during pregnancy and lactation, which will enable both practitioners and patients to better evaluate the risks and benefits of medication use during this time.3,4 History The first regulations on drug labeling were introduced between 1962 and 1979 in response to the thalidomide disaster in the early 1960s. Although thalidomide was never officially approved for use in the United States, it was distributed to more than 1,000 physicians for investigational use and resulted in at least 17 confirmed cases of phocomelia in this country. As a direct result of this tragedy, Congress passed the Kefauver-Harris amend116 ments in 1962 to provide tighter regulation of drug approval by the FDA.4 The FDA later developed the 1979 Labeling for Prescription Drugs Used in Man, which included pregnancy labeling regulations and introduced the pregnancy letter risk categories that are illustrated in Table 1.4,5 Although the use of these pregnancy risk categories unequivocally improved drug safety, criticism has been extensive. The most prominent criticism was voiced by the Public Affairs Committee of the Teratology Society in 1997, which stated a unified opinion that the pregnancy risk categories are confusing and provide an inaccurate source of information for patient counseling.4,6 Other common critiques include the omission of pregnancy and lactation safety data for drugs without adequate studies to demonstrate risk, the absence of information for accidental exposures, and the nature, severity, timing, incidence rate, or treatment of potential fetal injury.4,6,7 There also was concern that the letter designations could be misinterpreted as a grading system.8 Finally, the pregnancy risk categories focused on negative effects to the fetus or child, but did not give information about the potential effects of not treating a pregnant woman for conditions such as hypertension or epilepsy.9 This minimalized system did not sufficiently address the complexities of drug use in a pregnant patient, and resulted in a diminished capacity to assess the risks versus benefits of therapy accurately.4 To address these concerns, the FDA approved and published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling on Dec. 3, 2014.10 This document is referred to as the Pregnancy and Lactation Labeling Rule (PLLR or “Final Rule”). The PLLR was released after a decade of development.3 Goals of the PLLR include providing a format that is helpful to patient counseling and facilitating the transfer of clinical information without providing a scripted protocol for the health care provider that may become antiquated as new data are discovered.4 Labeling changes The format of the new label incorporates a new streamlined design and begins with a brief description of any available pregnancy registry contact information for the specific drug product. The PLLR also removes the pregnancy letter categories. Other core elements of the PLLR include three main subsections in the following order: 1. Risk summary: This section describes the probability of fetal developmental abnormalities or adverse outcomes in humans. If the expected risk is based on human data, there will be a brief summary of the data; if the expected risk is extrapolated from only animal data, a standardized scale describing the risk (none, low, moderBulletin / March 2015 Materia Medica Table 1. FDA pregnancy risk using the letter labeling categories.11 Risk Category A FDA Definition of Risk Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Figure 1. Comparison of current prescription drug labeling with the new labeling requirements.10 ate, high or unknown) will be listed. If a drug is not systemically absorbed, the following statement will appear: “[Name of drug] is not absorbed systemically from the [part of the body] and cannot be detected in the blood. Maternal use is not expected to result in fetal exposure to the drug.”4, 8, 10 2. Clinical considerations: This section includes pertinent information for prescribing decisions and patient care. Information about unintentional exposure, if known, also will be inBulletin / March 2015 cluded. This section also discusses the risks of not treating the condition in question, necessary dosage adjustments during pregnancy, unique or increased adverse reactions during pregnancy, and potential fetal complications and possible interventions. In addition, the use of the drug during labor and delivery, if known, will be contained in this section.4 3. Data for both pregnancy and lactation: Human and animal data are presented in this section, with human data presented first. This section describes the study type, exposure information (dose, duration and timing), or any identified fetal abnormalities or other adverse effects.4 The section of prescribing information previously titled “Nursing Mothers” will be relabeled as “Lactation.” The updated label follows the same format as the updated pregnancy label, with separate sections for risk summary, clinical considerations and data.8,10 Continued on Page 118 117 Materia Medica From Page 117 New to the labeling is a subsection entitled “Females and Males of Reproductive Potential.” This section includes information about the need for pregnancy testing, recommendations for contraception, and information about infertility if this information is known for the drug. 10 A visual comparison of the changes is illustrated in Figure 1. Timeline for implementation The labeling changes required by the PLLR go into effect June 30, 2015. Prescription drugs and biologic products submitted for approval after June 30, 2015, will use the new format immediately, while new labeling for current prescription drugs approved on or after June 30, 2001, will be phased in gradually. Labeling for over-thecounter medications will not change, as these products are not affected by the PLLR.10 Conclusion The enactment of the PLLR should improve the ability of both health care practitioners and patients to understand the risks and benefits associated References Ventura SJ, Curtain SC, Abma JC, et al. Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 19902008. Natl Vital Stat Rep. 2012; 60: 1-21 Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004; 191: 398-407. Gaffney A. FDA scraps pregnancy labeling classification system in favor of new standard. Regulatory Affairs Professional Society. Available at http://www.raps.org/Regulatory-Focus/ News/2014/12/03/20893/FDA-Scraps-Pregnancy-Labeling-Classification-System-in-Favor-of-New-Standard/. Accessed February 11, 2015. Ramoz LL, Patel-Short NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy. 20144; 34: 389-95. Kuehn BM. Frances Kelsey honored for FDA legacy: award notes her work on thalidomide, clinical trials. JAMA. 2010; 304: 2109-12. Public Affairs Committee of the Teratology Society. Teratology public affairs committee position paper: pregnancy labeling for prescription drugs: ten years later. Birth Defects Res A Clin Mol Teratol. with the use of medication during pregnancy and lactation. The new labeling provides additional information that was not present in the previous requirements, and improves the standard of care of this challenging patient population. Dr. Fancher is an assistant professor of pharmacy practice at Duquesne University Mylan School of Pharmacy. She also serves as a clinical pharmacy specialist in oncology at the University of Pittsburgh Medical Center at Passavant Hospital. She can be reached at [email protected] or (412) 396-5485. 2007; 79: 627-30. U.S Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling, 73 Fed. Reg. 30831-68 (May 29, 2008). FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products. U.S. Food and Drug Administration. Available at http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm. Accessed February 11, 2015. Bonner L. New pregnancy, lactation drug labeling will replace letter categories. Pharmacy Today. 2015; 21: 30. Pregnancy and lactation labeling final rule. U.S. Food and Drug Administration. Available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm. Accessed February 11, 2015. FDA pregnancy categories. U.S. Department of Health & Human Services. Available at http://chemm.nlm.nih.gov/pregnancycategories.htm. Accessed February 11, 2015. Free classified ad online Place a classified advertisement in the Bulletin, and your ad will appear online FOR FREE on the ACMS website, www.acms.org, for the duration of your advertisement. For information, call Meagan Welling at (412) 321-5030, ext. 105. 118 Bulletin / March 2015 We will reduce your medical office and supply costs. Allegheny 3 reasons Medcare to consult We will reduce your medical office and supply costs. Mike Gomber for your medical supply needs 3 reasons Mike 1 Mike isn’t just a “sales rep.” to consult is a professional consultant with an MBA and 30 yearsMike experience Gomber serving physicians. Savings, Service forand yourSolutions! medical supply needs Comprehensive foot and 2 MaCalus V. Hogan, MD Stephen F. Conti, MD William E. Saar, DO Alex J. Kline, MD Carl T. Hasselman, MD Dane K. Wukich, MD Mike will find the best solution to ankle care that is head and Mike isn’t just a “sales rep.” Mike 1 your medical supply needs, not shoulders above the rest. is a professional consultant with just the “product of the month” an MBA and 30 years experience that others are pushing. UPMC Foot and Ankle Center serving physicians. From initial diagnosis through treatment and Allegheny Medicare is endorsed rehabilitation of foot, ankle, or lower leg conditions, Mike will find the best solution to 2 County by the Allegheny Medical the UPMC Foot and Ankle Center will work to medical supply needs, not Society—the only your medical supply provide you with the best possible care for your company that is! just the “product of the month”specific condition. As some of the most highly trained, well-respected orthopaedic foot and that others are pushing. “The best solution to your 3 medical supply needs.” ankle surgeons in western Pennsylvania, we have Michael L. Gomber, MBA experience successfully treating the simplest Medicare is endorsed 3 Allegheny More than 30 years meeting to the most complex conditions. We’re here to by the Allegheny County Medical help you get back on your feet, pain-free, physicians’ needs Savings, Service and Solutions! Society—the only medical supply as quickly as possible. (412) 580-7900 company that is! For more information, or to schedule an Michael L. Gomber, MBA Fax (724) 223-0959 appointment, call the UPMC Foot and Ankle Center More than 30 years meeting physicians’ needs at 844-ANKFOOT (844-265-3668) Email: michael.gomber 412.580.7900 Fax: 724.223.0959 or visit UPMC.com/FootAndAnkle. E-mail: [email protected] @henryshein.com A Allegheny Medcare Allegheny Medcare endorsed by LLEGHENY COUNTY MEDICAL SOCIETY Savings, Service and Solutions! Allegheny Medcare Henry Schein, a Fortune 500 Company Michael L. Gomber, MBA Together to serve to provide a one-stop More than 30 years meeting physicians’ needs solution for all your needs 412.580.7900 Fax: 724.223.0959 endorsed by ALLEGHENY COUNTY MEDICAL SOCIETY Bulletin / March 2015 E-mail: [email protected] Allegheny Medcare Affiliated with the University of Pittsburgh School of Medicine, UPMC is ranked among the nation’s best hospitals by U.S. News & World Report. Henry Schein, a Fortune 500 Company Together to serve to provide a one-stop solution for all your needs 119 Legal Report Narrow network contracting: Are we finally poised to make progress? T he so-called “thought leaders” in health care policy have been predicting that a new model of health care contracting will provide the basis for a higher quality, more efficient and less expensive national health care system, i.e., the Triple Aim, for many years. People have mentioned management care contracting, pay for performance contracting, narrow network contracting, and value-based purchasing. Some think the managed care contracting reform started in the early 1990s with the Clinton Health Security Act, but the Federal Health Maintenance Organization (HMO Act) was actually passed in 1973. Medicare was created by the Social Security Act in the early 1960s, so clearly the idea of health care reform has been percolating for quite some time. Although it has been a long time coming, Western Pennsylvania actually may now be ready to take that next step, although it appears that employers rather than providers or patients may be leading that charge. Early managed care and anti-trust challenges The two inherent structural problems with early managed care contracting were (1) that it was based almost solely upon market power and economic leverage, and (2) that the concept was designed to restrict choice and deny services. Even today, with very sophisticated electronic health records (EHR) systems and quality 120 Michael A. Cassidy, Esq. management protocols, there has been little competition based on just quality and cost performance. The deck was previously stacked in favor of the large health care insurers, because even prior to the Clinton attempt at health care reform, there were a host of multi-billion dollar third-party payers, but hospital providers and, even more so, physician providers, were relatively small economic players in the health care business spectrum. Early managed care contracting focused primarily on numbers, i.e., how many covered lives, how many beds, how many providers? Managed care organizations did not offer transparent pricing or documented quality improvements to drive health care decisions. Instead, primary care physicians (PCPs) were designated to be “gatekeepers” and specialty services needed prior authorization. Patients resented the concept that money was saved by utilization control and that PCPs were paid capitation regardless of whether services were provided, and PCPs resented being the obvious “enforcers.” Attempts by physicians to organize Independent Physician Associations (IPAs) and by hospitals and physicians to organize physician hospital organi- zations (PHOs) and preferred provider organizations (PPOs) were largely thwarted by antitrust challenges as conspiracies to fix prices. Competition was even more constrained in Western Pennsylvania because of the combination of a high percentage of government programs and the early dominance of the commercial market by Pennsylvania Blue Shield, and the then four state Blue Cross plans (Western Pennsylvania, Capital, Northeast and Independence). The merger of some of those plans has further consolidated the insurance market. Coupled with the rise of UPMC as first a dominant health care provider and then as a major health care insurer, the local environment has impeded the ability of the smaller players to compete and discouraged the need for the big players to do so because the status quo was satisfactory to them. Early attempts by physician providers to create medical practices with sufficient size to play in that arena were preempted by the acquisition of many of those early movers and of many other physicians by the systems. Although hospital physician integration, primarily through employment, was always a national trend, the percentages of physicians employed by all hospitals in Western Pennsylvania is among the highest in the country. Quality and price transparency The contractual separation by Bulletin / March 2015 Legal Report UPMC and Highmark/AHN is creating the type of market place disruption that should create the opportunity for health care competition; both systems are now entering into new competitive arrangements, and the entry into the market of new commercial third party payers also is creating new competitive opportunities. Although individual consumerism has been touted as a critical part of health care reform, the resources and data and planning necessary for individual consumerism has always made that a very difficult proposition. Even if individual consumers had the data and the resources necessary to choose among health care providers, (which they usually do not) the fact that many health care events occur on an emergency or at least a time critical basis makes it practically impossible for individual consumers to shop around when confronted with specific health care decisions. Pittsburgh Business Group on Health Although individual consumers may not and may never have the ability to affect competition, the employers that purchase health care coverage do have the resources to do that “shopping.” The Pittsburgh Business Group on Health (PBGH) is poised to be a catalyst on behalf of employers in this new health care market place. PBGH is an organization of approximately 75 primarily large employers in Western Pennsylvania, with approximately 400,000 employees (and obviously significantly more covered lives). Eighty percent of those employers are self-insured and they represent a national health care spend of approximately $5 billion and a regional health care spend of approximately $3 billion. PBGH is spearheading efforts to provide both comparison quality data and transparent pricing for health care services to their employer members so that those employers may utilize that data when constructing and offering health care coverage to their employees. This is the type of information necessary to effectively implement narrow network contracting. Continued on Page 122 Our Health Law Practice Group tackles your legal issues and concerns so you can handle the more important work…caring for your patients. 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. m e d l a w b l o g . c o m tuckerlaw.com Bulletin / March 2015 1500 One PPG Place Pittsburgh, PA 15222 412-566-1212 2 Lemoyne Dr., Suite 200 Lemoyne, PA 17043 717-234-4121 Michael A. Cassidy, Esq. [email protected] 412-594-5515 121 Legal Report From Page 121 Narrow network contracting Narrow network contracting is just one of many names health care consultants have used to define a new generation of competitive contracting. We could just as easily refer to it as value-based contracting, direct contracting, or even pay for performance. The concept is simply that the primary purchaser of health care services, employers, are in a much better position to proactively conduct the purchase than individual consumers. This is predicated upon the selection of health care providers, both institutional and individual, who can now provide and be selected on a basis that includes both quality and cost efficiency. With the type of information that is now available, health care purchasers can now engage in competitive contracting, regardless of how it is labeled. This process is now being discussed as “reference pricing,” which in reality is just a new name for the process of establishing a maximum price a purchaser is willing to pay and communicating that in a “request-for-proposal” (RFP) manner to health care systems as an invitation to agree to accept that price. All of this sounds new, but this is the way most other businesses have routinely conducted business. Many other businesses engage in price comparison, RFPs, and group purchasing organizations to minimize cost and quality variability for the benefit of the ultimate consumers. Employers and health plans are now poised to participate in that same process. Physician participation What will be the role of physicians in this process? As usual, the ability of physicians to play a meaningful role will be dependent upon their practice situation. Independent practices will be better situated to actively participate in this process, and to negotiate for inclusion in the narrow networks, but only if they have the quality data discussed above. Obviously this suggests that indepen- dent physicians would benefit from participating in larger practices or voluntary networks, such as Accountable Care Organizations (ACOs) which may be the formal Medicare Shared Savings programs or commercial network of similar design. Physicians employed by hospitals would not normally have the independent authority to actively participate in these new models, but that does not mean they should not be attuned to the impact of these new contracting models. Since the hospitals or institutional employers will be utilizing the physicians as key pieces of network designs in contracts, those physicians should strive to have their compensation and staffing decisions reflect the contributions that they can make to these networks. Mr. Cassidy is a shareholder with Tucker Arensberg and chair of the firm’s Healthcare Practice Group; he also serves as legal counsel to ACMS. He can be reached at (412) 594-5515 or [email protected] The Bulletin depends on its advertisers. Be sure to tell them you saw their ad here. 122 Bulletin / March 2015 Special Report Updates from the ACHD There is an ongoing outbreak of shigellosis in Allegheny County. During most years, fewer than 10 cases of shigellosis are reported to the Allegheny County Health Department (ACHD). From October 2014 through January 2015, 25 cases were reported. We estimate that there are 10 to 20 cases for every one reported, given that most infected people do not seek care or do not get tested. The median age of reported cases during this period was 3 years. About half of the cases attend child care facilities; as per state regulations, they are excluded until they have 2 negative stool cultures. ACHD has been working with daycare centers to promote improved hand hygiene. among personnel of the Pittsburgh Penguins professional hockey team. Since that time, ACHD has received numerous reports of parotitis in the community. Some patients with parotitis have tested positive for influenza A, one adult with orchitis tested positive for mumps, and many others with parotitis were either not tested or tested negative for mumps. This flu season, the Centers for Disease Control (CDC) has received numerous reports from multiple states of parotitis in patients with lab-confirmed influenza. Thus, the Pennsylvania Department of Heath recommends testing all suspected mumps patients for both mumps and influenza (with buccal swab and throat swab, respectively, placed in viral transport media). Health care personnel should have documentation of 2 MMRs or a positive mumps titer. Suspected mumps Suspected measles In December 2014, there were several cases of confirmed mumps If you suspect a patient has measles, please contact ACHD (412) 687- Kristen Mertz, MD, MPH Shigellosis 2243 as soon as possible. ACHD can facilitate PCR testing (on throat swab and urine) and serologic testing at the state health department laboratory. As of February 23, we have no confirmed cases of measles in Allegheny County in 2015. Disease reporting For a list of reportable conditions in Allegheny County, go to the ACHD homepage (www.achd.net) and click on “Reportable Diseases and Conditions” on the left-side menu. Providers should enter all reportable diseases into PANEDSS, the state’s electronic disease surveillance system. To register for PA-NEDSS, go to https://www.nedss. state.pa.us and click on “Activate your account here” in the left-hand column; call (717) 836-3618 if you need a registration number and passcode. Dr. Mertz is a medical epidemiologist with the ACHD. For more information, call (412) 687-2243. Writers Wanted Please don’t pass up the opportunity to have your voice be heard. To submit a writing sample or for more information, contact Bulletin Managing Editor Meagan Welling, (412) 321-5030, ext. 105, or email [email protected] Bulletin / March 2015 123 Special Report National Healthcare Decisions Day N ational Healthcare Decisions Day (NHDD), April 16, is a 50-state initiative to inspire, educate and empower the public and providers about the importance of advance care planning. This annual event which began in 2008 encourages all adults to talk about their choices for future health care treatment and to document those choices in an advance directive. Most advance directives consist of one document with two parts: the Health Care Power of Attorney and the Living Will. While primary care and specialty practices will not be able to reach out to all their patients on National Healthcare Decisions Day, it can be a time to consider if the practice is able to do more to assure patients have information and tools to complete an advance directive. One barrier to advance care planning is that many individuals believe they are too young or too healthy to need that discussion or to complete the form. They may be unwilling to consider the possibility of becoming incapacitated and unable to make their health care treatment choices known. While ACT 169 of 2006, Advance Health Care Directives and Health Care Decision-making for Incompetent Patients Law, provides a default priority list for a health representative, that person may not be the one who has knowledge of the incompetent person’s values and choices. For this reason, it is recommended for medical practices to encourage everyone age 18 and older to complete a Health Care Power of Attorney document and engage in advance care planning discussions 124 Marian Kemp, RN Judith S. Black, MD, MHA with family and loved ones. It also is useful to convey the importance of patients having an ongoing conversation over the years with their health care decision-maker, family and health care provider. An advance directive with a Living Will is very important for those of any age who are living with serious illness, one or more chronic conditions, and the elderly. For these patients, this written statement of the patient’s personal choices regarding life-sustaining treatment and other care can guide treatment as the end of life approaches. More doctors are recognizing the importance of helping to facilitate advance care planning with their patients. According to the American Medical Association (AMA), physicians play an important role in initiating and guiding the advance care planning process by making it a routine part of care for all patients, which is revisited regularly to explore any changes a patient may have in his or her wishes. This process ultimately can benefit patients; it can provide them with a sense of control and peace of mind with regard to their future health care.1 A barrier to advance care planning in the clinical environment is that it may be believed to take too much time out of a busy schedule. However, the conversation can occur over more than one visit or the office could schedule a specific advance care planning visit. Practices also may consider empowering nurses and social workers in this role. While it may be difficult to find the time, for some practitioners it can be difficult to get the conversation started. The following are key phrases that can be used. • What do you understand about your health? • What do you understand about your prognosis? • What are your concerns about what lies ahead? • What kind of trade-offs are you willing to make? • How do you want to spend your time if your health worsens? • Who do you want to make decisions if you can’t? In addition to counseling patients about advance care planning, practices can make advance directives available to them. The only Living Will and Health Care Power of Attorney form endorsed by both doctors and lawyers in Pennsylvania is available free at http://www.acba.org/portals/1/pdf/LivingWillPowerofAttorney.pdf. A useful tool for the public is an interactive website that serves as a resource for patients and families Bulletin / March 2015 Special Report navigating medical decision-making. Found at http://www.caringcommunity. org/advanced-care-planning/planning/ prepare-for-your-care/, it assists people to think through how health care decisions would be made if a person is unable or unwilling to guide their own health care. It is user-friendly, written at a 5th-grade level for ease of use, has helpful videos and a narrator for every aspect of advance care planning one should address. NHDD provides a special opportunity for physicians to plan to speak with their patients about important documents that will make their medical treatment wishes clear if they are inca- pacitated or face a terminal illness. For those patients for whom the clinician “would not be surprised if they died within a year,” then consideration of the Pennsylvania Orders for Life-Sustaining Treatment or the POLST is appropriate. For more information on POLST, email [email protected] Marian Kemp, a nurse, is the POLST coordinator for the Coalition for Quality at the End of Life. She can be contacted at [email protected] Dr. Black was the medical director for Senior Markets at Highmark from 1998 to 2015. She is now medical director of the Medical Service Line of Allegheny Health Network. She can be reached at [email protected] *This article is part of a series on end-of-life care leading up to Hospice Month in November. If you are interested in submitting an article on this topic, please contact Bulletin Managing Editor Meagan Welling at [email protected] Reference 1. http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/aboutethics-group/ethics-resource-center/end-oflife-care/advance-care-directives.page? 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 department at (412) 321-5030, ext. 110, or email [email protected] Affiliated with Pennsylvania Medical Society and American Medical Association Bulletin / March 2015 125 Special Report Meaningful Use attestation is complete, now breathe a sigh of relief – or can you? Pennsylvania Medical Society’s Practice Support Team N umerous eligible professionals have been working diligently to meet Meaningful Use (MU) measure objective thresholds, whether by using the Flexibility Rule or by attesting to the stringent requirements of Stage 2 in 2014. The Pennsylvania Medical Society (PAMED) has received quite a bit of feedback from our membership regarding the MU program, and some potential problems and issues they are experiencing such as: • Attestation rejections related to information within the PECOS system not aligning with the information within the EHR Incentive Program Registration and Attestation System • EHR payment adjustment being assessed although attestation was successful • Prepayment audit letter received only after two days of submitting Stage 2 attestation Let’s take a moment to discuss each one of these topics individually. 1. Attestation rejections due to PECOS mismatch with EHR Incentive Program Registration According to the Centers for Medicare and Medicaid Services (CMS), providers who received this rejection would need to contact their local Medicare Administrative Contractor (MAC) 126 Enrollment department as information within the PECOS system does not match what is listed in the EHR registration and attestation system. When researching this problem, PAMED found a direct correlation to the revalidation process. Numerous practices having revalidated one or more providers within their group, however, still had remaining providers yet to be revalidated, a scenario that seemed to have caused the attestation to be rejected. Providers still in the revalidation process also would be rejected for a PECOS mismatch. In conversation with CMS representatives, revalidation processing may range from 60-210 days. In some instances, the local MAC needed to “recycle the provider file” to correct the problem. This in turn, by the press of a button, corrected the problem, allowing the practice to resubmit its attestation. In other instances, the Electronic Funds Transfer (EFT) information for the group needed to be updated for those providers yet to be revalidated. 2. EHR payment adjustment being assessed despite successful attestation Imagine being a successful user of MU and receiving your 2015 Medicare reimbursements reduced by 1 percent with remittance code N700, Payment adjustment based on Electronic Health Record. Your practice never received a letter from CMS advising that your provider was subject to a penalty, your attestations were successful, and you have documentation stating such. One of your providers was audited, but the result of that audit was favorable again with supporting documentation. So, how can your practice be getting assessed a penalty? In order to get to the root of the problem, PAMED placed a call to the EHR Information Center (888-7346433) and is awaiting further information on this issue. At this point, we do not have any clear cut answers as to how and why this is happening. We do know that an informal review form should not be completed unless a penalty letter was received by the provider. This is an error on CMS’ end which will need to be corrected. What is unfortunate is the administrative burden the practice’s billing staff will face in reapplying the 1 percent corrected payments. 3. Prepayment audit letter received only after two days of submitting Stage 2 attestation We can only speculate that CMS has realized the difficulties physicians have had meeting the objective thresholds for Stage 2 due to the stringent requirements. Therefore, soon after providers submit attestation, audit requests follow shortly thereafter. Some feedback PAMED has received from its members has been audit requests received after two days of attestation to an audit request received hours after Stage 2 attestation. Providers need to be certain to have all of their documentation ready and in hand to send to Figliozzi and Company to support all the Core and Menu Bulletin / March 2015 Special Report objectives. Any measures that were answered with a yes/ no, screenshots, or reports from the EHR supporting that answer should be provided. Let’s take the example of Core Measure 11, Generate patient list by specific conditions. When attesting, the system simply states “generate at least one report listing patients of the eligible professional with a specific condition.” The provider must mark a yes or no. To support this measure in the case of an audit, the practice will need to show that a report was indeed run during the attestation period to support their answer. MU continues to be a controversial issue and struggle for many providers. Those providers who choose not to participate due to the burdensome requirements and associated costs, as well as those providers who choose to participate to avoid the associated payment adjustments to their Part B fee-for-service reimbursements, must deal with aggravating issues like those issues listed above. PAMED has the resources to help practices meet MU requirements, earn incentives, and avoid penalties. One of the most common causes for a failed audit is insufficient documentation of the Security Risk Analysis (SRA). PAMED has a toolkit available to assist practices in the completion of the SRA. This toolkit and other HIPAA-related resources can be found at www.pamedsoc.org/hipaa. PAMED has educational webinars on MU, available at www.pamedsoc.org/webinars. MU incentives and penalties also will be a topic at our spring practice manager meetings across the state. Learn more and register at www.pamedsoc.org/managermeeting. Watch your email inbox for the Daily Dose, PAMED’s daily, all-member email, as it contains the latest news and resources to help you and your practice navigate the challenges you face, such as MU. PAMED members who have questions about MU can contact our Practice Support Team at (717) DOC-HELP, that’s (717) 362-4357. Who Do You Know? Who you know may help the future of medicine. Are you friends with a state legislator? Your Congressman? If so, PAMED wants to know. As part of our grassroots action team, we seek members who know elected leaders and are willing to talk to them about issues? Visit www.pamedsoc.org/gotnames and complete the online form to join the team today or email Larry Light at [email protected] 777 East Park Drive Harrisburg, PA 17105 (800) 228 7823 Bulletin / March 2015 127 Special Report Coping with malpractice litigation The Foundation of the Pennsylvania Medical Society is here for physicians during life’s most challenging moments T he phone rings in the middle of the night. Mark Lopatin, MD, has to decide whether to tell a frail, 79-year-old patient with Parkinson’s disease complaining of a fever whether to stay in bed, take Tylenol and drink plenty of fluids, or venture out into the cold night to his local emergency room. The decision should be easy, but Dr. Lopatin, who has dealt with malpractice litigation, says it is not. Six out of every 10 physicians practicing today have been sued for malpractice at least once, according to the Foundation of the Pennsylvania Medical Society’s Physicians’ Health Programs (PHP). “The effects of malpractice on the individual should be taken seriously,” says Medical Director Jon Shapiro, MD. “As physicians, it represents a major area of stress, because we so often link who we are to what we do.” Kathleen Chancler, a principal in Post & Schell’s Professional Liability Practice Group in Philadelphia, agrees. “When a physician is named personally as a defendant in a malpractice suit, it’s often a difficult experience for them,” she says. “Physicians enter the profession for altruistic reasons, and then find themselves entrenched in an adversarial litigation process that involves lawyers, depositions, and courtrooms, which ultimately takes them away from time with their patients.” According to the PHP, a malpractice suit is business to many lawyers 128 For counseling or referral service, call the Physicians’ Health Programs toll-free at (800) 228-7823 or email [email protected] Find out what PAMED has done to improve the medical liability environment in Pennsylvania, and what it is doing to continue to bring more tort reform to Pennsylvania at www.pamedsoc.org/medliability. and judges – just part of their jobs. To the physician, a medical liability suit questions his or her professional competence. The outcome of the suit can affect the physician’s self-esteem and his or her standing among colleagues and in the community. Judges with numerous cases on the docket and attorneys who participate in multiple malpractice cases can afford a certain detachment, but it contrasts sharply with how the physician is affected. “If you are facing the litigation process, you can turn to the PHP for information and support,” says Dr. Shapiro. “PHP staff are available by telephone to discuss your feelings on the case, refer you to someone who can give you more information about the legal system, and help you gain a better perspective on the claim or suit. “Adaptive strategies can keep the suit from becoming a catastrophe,” Dr. Shapiro adds. “It helps to be able to talk to someone who has endured a common experience to realize you are not alone. That’s the benefit of orga- nized medicine.” Dr. Lopatin like most physicians, has faced malpractice litigation. He said the legal battle was traumatic. “My career and my license were at stake,” he says. “Counseling was key to getting through the experience. I’ve learned that the sun will come up the next day, and it is up to me as to how I will receive it.” Joining Pennsylvania Medical Society (PAMED) and getting involved with advocacy efforts regarding malpractice reform helped Dr. Lopatin feel like he was taking back some control. His participation as chair of the Montgomery County Medical Legal Committee provided him with further understanding of how the legal system works. As for Dr. Lopatin’s patient who called in the middle of the night? He stayed warm in bed and felt better by morning – a testament to the physician’s initial instincts. “I like to use this example when discussing how defensive medicine impacts decision-making, Continued on Page 130 Bulletin / March 2015 Bulletin / March 2015 129 Special Report From Page 128 because the patient is actually my father,” Dr. Lopatin says. “Had he not been a close relative, I absolutely would have sent the patient to the emergency room.” More work needs to be done to address the political intricacies of malpractice liability in Pennsylvania. “In the meantime, it’s important to remember that the PHP can help physicians learn to deal with the anxiety and ultimately survive the pressure by turning the negative stresses of a lawsuit in a positive direction,” Dr. Shapiro says. The Foundation of the Pennsylvania Medical Society provides programs and services for individual physicians and others that improve the well-being of Pennsylvanians and sustain the future of medicine. Visit the Foundation at www.foundationpamedsoc.org. Reprinted with permission from Pennsylvania Physician Magazine © 2015. Classifieds HELP WANTED Join Pennsylvania’s Leader in Emergency Medicine Emergency Resource Management, Inc., (ERMI) is now accepting EM BE/ BC or other board certified physicians with experience for multiple positions throughout western Pennsylvania. ERMI is the largest employer of emergency medicine physicians in Pennsylvania and is part of UPMC, one of the nation’s leading integrated health care systems. We offer an outstanding compensation and benefit package, including occurrence malpractice insurance, employer-funded retirement plan, paid health insurance, CME allowance, and more. For more information about joining one of Pennsylvania’s largest and most successful physician groups, contact our recruiter at 412-432-7400, toll-free 888-647-9077, or email at [email protected] Visit www.EmergencyResourceManagement.com for more information. 130 The Allegheny County Medical Society recognizes its member physicians on National Doctors Day Monday, March 30, 2015 We appreciate your dedication to the practice of medicine! Bulletin / March 2015 Proud to be endorsed by the Allegheny County Medical Society SAY HELLO TO NORCAL EXPERIENCE THE MUTUAL BENEFIT PMSLIC Insurance Company is transitioning to its parent company— NORCAL Mutual Insurance Company. Same exceptional service and enhanced products, plus the added benefit of being part of a national mutual. As a policyholder-owned and directed mutual, you can practice with confidence knowing that we put you first. Contact an agent/broker today. 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