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SUMMER 2018 NEWSLETTER

SENTINEL President’s Message Why Should I Care About Advocacy? We all work long hours in direct patient care, leaving little available time for any other activities, particularly advocacy. However, I want to suggest that we need to do more to promote patient safety in anesthesia care and to preserve the team approach to care.

Tom Witkowski, M.D., FASA PSA PRESIDENT

I cannot remember a period in the last twenty years with so much activity damaging to the physician-patient relationship as this one. As medical professionals, we need to stay active.

In an example of why we need to stay vigilant, New York released a budget with a line item authorizing independent CRNA practice. What was alarming was that there wasn’t any discussions prior to the budget release by the governor’s office that this would occur. This triggered a response from the New York State Society of Anesthesiologists. Working in conjunction with other medical groups, they were able to persuade legislators that this would create a two-tiered level of care within the state and that the budget was not an appropriate place for a medical standard of care decisions. Dealing with this problem required several months of work by a number of our colleagues in New York. Aside from independent CRNA practice, anesthesiologists are confronted by a number of issues which impact our ability to care for patients. Drug shortages directly impact us on a daily basis, causing a change in how we render care. The response to the opiate crisis has reduced the availability of analgesic drugs. Legislation has passed that requires additional training on opiates to maintain our license. There is consideration by legislation to develop a committee which will define how opiates are prescribed with probable legal penalties for failure to comply. Other legislation that impacts us is balance billing, hospitals and private equity firms are purchasing practices — anesthesiology practices are popular targets. The next step to improve profitability will be to change how care is delivered. Nonphysician providers seek to make themselves equal to physicians by government decree. All of these things impact how you work, interact with your patients, and care for them. I cannot remember a period in the last twenty years with so much activity damaging to the physician-patient relationship as this one. As medical professionals, we need to stay active. Only through continued advocacy will we be able to continue to provide the care we should and advance the practice of medicine. We owe it to our patients and ourselves. I am happy to talk to any of you about any issues you are experiencing. STAYING INVOLVED IS CRITICAL.

The Pennsylvania Society of Anesthesiologists | 717-558-7750 ext. 1596 | www.psanes.org


Table of Contents | SUMMER 2018 3 | In This Edition 4 | ANESTHESIOLOGY 2018 5 | Waking Up Safer? An Anesthesiologist’s Record 6 | $200 Million JUA Raid Found Unconstitutional by Federal Court 8 | Legislative Update 10 | Chest Wall Blocks 12 | Drug Costs, Drug Shortages and Group Purchasing Organizations 14 | The Checklist Effect 15 | Physicians Against Drug Shortages 16 | Physician Convicted By Federal Jury Of Illegally Sharing Patient Medical Files 18 | LEGISLATIVE CONFERENCE 2018 Highlights Drug Shortages, Opioid Crisis 20 | KNOW YOUR EQUIPMENT: Intra-Arterial Blood Pressure Monitoring 22 | Fellow of the American Society of Anesthesiologists

2017-2018 Officers President Tom Witkowski, M.D., FASA President-Elect Richard Month, M.D., FASA Vice President Shailesh Patel, M.D. Past President Bhaskar Deb, M.D. Secretary-Treasurer Margaret M. Tarpey, M.D. Asst. Secretary/Treasurer Patrick J. Vlahos, M.D. District IX Director Erin A. Sullivan, M.D., FASA Alternate District Director Joseph F. Answine, M.D., FASA

Delegates to the ASA House of Delegates Joseph F. Answine, M.D., FASA Donna Kucharski, M.D., FASA Joshua H. Atkins, M.D., Ph.D., FASA Richard Month, M.D., FASA Andrew Boryan, M.D., FASA Kristin Ondecko Ligda, M.D., FASA Robert A. Campbell, M.D. Shailesh Patel, M.D. Bhaskar Deb, M.D. Mark J. Shulkosky, M.D., FASA Joseph W. Galassi, Jr., M.D. Margaret M. Tarpey, M.D. David M. Gratch, D.O. Thomas Witkowski, M.D., FASA Andrew Herlich, M.D., FASA Alternate Delegates to the ASA House of Delegates Adam Childers, M.D. Craig L. Muetterties, M.D. Lee A. Fleisher, M.D. Richard P. O’Flynn, M.D., FASA Shannon Grap, M.D. Ben Park, M.D. Michael S. Green, D.O. Saket Singh, M.D. Mark Hudson, M.D. Patrick J. Vlahos, D.O. Philip A. Mandato, D.O. Scott Winikoff, M.D., FASA Gordon Morewood, M.D. Delegate, Pennsylvania Medical Society House & Specialty Leadership Cabinet Shannon Grap, M.D. Alternate Donald Martin, M.D. Carrier Advisory Representative Gordon Morewood, M.D.

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SENTINEL | The Pennsylvania Society of Anesthesiologists Newsletter

SENTINEL NEWSLETTER Association Director Libby Dietrich Editor Richard P. O’Flynn, M.D., FASA President Tom Witkowski, M.D., FASA The PSA Newsletter is an official publication of the Pennsylvania Society of Anesthesiologists Inc. Opinions expressed in this newsletter do not necessarily reflect the Society’s point of view. All correspondence should be directed to: PSA Newsletter 777 East Park Drive, P.O. Box 8820 Harrisburg, PA 17105-8820 717-558-7750 ext. 1596

www.psanes.org


IN THIS EDITION In response to a member survey, the Sentinel is considering a change from a print version to an electronic version that would be delivered to your email inbox with the first electronic edition beginning in 2019. Our hope is to be able to provide more timely information with six issues of the Sentinel each year. All past editions of the Sentinel will continue to be archived on the PSA website. We will make the official decision after the Board of Directors reviews the transition plan at their Fall meeting. We welcome any comments concerning his change. This issue of the Sentinel is packed with valuable information for all of our members. A few highlights…. The recent Supreme Court decision regarding the attempted State takeover of Joint Underwriting Association (JUA) funds is fully explained. This is a win not only for physicians insured by the JUA but also for all patients of these physicians. The “$200 million surplus excess” funds that the State Legislature attempted to appropriate into the Commonwealth’s General Fund by Act 44 was ruled an unconstitutional taking of private property. Our general counsel, Charles Artz, describes a recent case against a physician convicted of illegally sharing patient medical files, violating HIPPA privacy regulations. This is a warning to all physicians that HIPPA privacy regulations are to be taken seriously and any OIG contact is a serious concern and competent legal counsel should be engaged immediately. While the involved physician was a gynecologist, not an anesthesiologist, it is easy to see how a similar situation could arise with an anesthesiologist, especially a pain practitioner. With summer upon us, while our thoughts turn to vacations and down time, this doesn’t mean our Harrisburg team gets to take it easy. The two-year legislative cycle is coming to a close and this is the time when much legislative activity really picks up speed. We are hopeful that the current Department of Health supervision regulations are finally put into legislation. Our lobbyist, Kevin Harley, reports on pending legislation and the recent House Professional Licensure Committee hearing on this bill. Other legislation being followed includes CRNA titling, fentanyl legislation and balance billing legislation. It has been an active session in the legislature and our lobbyists have represented us well. PSA member Robert Campbell was recently honored to be among a very small group of physicians invited to the White House for the President’s announcement of actions to control prescription drug prices. Dr. Campbell, chairman of “Physicians Against Drug Shortages” presents a detailed review of Group Purchasing Organizations (GPO) and their effect on drug prices and the shortages that have plagued medicine. I encourage everyone to read the article and go to the PADS website for more information. Our District Director, Erin Sullivan, reports on another successful and well attended ASA Legislative Conference and the multiple issues facing our specialty in the future. We continue with our “Know Your Equipment” series with a detailed review of intraarterial blood pressure monitoring. If you are planning on attending the ASA Annual meeting in San Francisco, make sure that you include time in your schedule on Saturday to attend the PSA membership meeting and lunch. Further information will be sent by email once final arrangements are known. As always, we welcome comments, suggestions or submissions. Contact us at info@psanes.org.

Richard O’Flynn, M.D., FASA EDITOR

The Pennsylvania Society of Anesthesiologists Newsletter |

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Meet us in the City by the Bay San Francisco, California

October 13-17 for ANESTHESIOLOGY 2018 The ANESTHESIOLOGY annual meeting is one way ASA celebrates and supports the profession. Each year features new scientific developments, technology and challenging cases in the field of anesthesiology. That’s why the ANESTHESIOLOGY annual meeting was created—it advances the knowledge of those serving the specialty, offers a community for anesthesiology providers to connect with each other, shares the latest scientific findings, and provides a platform for learning about the latest products and services the specialty has to offer.” - Sulpicio G. Soriano, M.D., FASA, Chair, Committee on Annual Meeting Oversight, James D. Grant, M.D., M.B.A., FASA, 2018 ASA President Early-bird rates end July 24. Save $100 when you book your hotel room through ASA’s hotel block. Register at www.asahq.org. meddcomm dont sleep ad 3 9.01.2017.pdf 1 9/5/2017 7:18:09 PM

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SENTINEL | The Pennsylvania Society of Anesthesiologists Newsletter


Waking Up Safer?

AN ANESTHESIOLOGIST’S RECORD

Dr. Berend Mets, Chair of the Department of Anesthesiology and Perioperative Medicine at Penn State University’s Hershey Medical Center wrote a book Joseph A. Answine, with the above title. M.D., FASA Before we get into the contents of the book, we should discuss whether our patients are safer now under anesthesia when compared to years past. Are our patients safer? Without question; yes! Advances in technology, pharmacology, education and team development have assured that. Have we reached the pinnacle in patient safety under anesthesia? I sure hope not and feel comfortable that the answer is “no”. Technology is continuing to improve right in front of our eyes, medications are becoming more precise in their mechanisms of action and their removal from the site of action and the body, and education is advancing with the birth of simulation and other new intellectual tools such as the Vortex. Enhanced Recovery After Surgery (ERAS) has demonstrated the benefits of a team approach uniting the professional silos into one mega-team with constant interaction. Anesthesiology has gone from the presence of a pulse to automated blood pressure measurement, pulse oximetry, continuous ECG, ETCO2, BIS monitoring, cerebral oximetry, invasive and noninvasive flow monitoring as well as the electronic medical record. We went from minimal data to possibly too much data to sift through and too many distractions. Our next major step forward may be ways to eliminate extraneous data and distractions; not more data but better data. We will never reach 100% safe, but that will always be the ultimate goal. Waking Up Safer? An Anesthesiologist’s Record is Dr. Mets’ personal journey as an anesthesiologist intertwined with the growth of the practice of anesthesiology as it pertains to making our specialty safer for our most coveted assets; our patients. The book bounces flawlessly back and forth between the two. Dr. Mets walks us through the dawn of anesthesia as well as the dawn of his career in South Africa treating Zulu patients who had bludgeoned and stabbed each other during weekend drunken battles. It is hard to believe that a gentleman still very active in his

field started by giving an anesthetic with just a manual blood pressure cuff and a finger on the pulse, and with very little attending oversight. Many books have been written on anesthesia history; many have described the exploits of Horace Wells and Thomas Morton. But, none have been written to be so easily understood by the lay-person; by the patient. Dr. Mets does just that in ‘Waking Up Safer?’ by very deliberately and eloquently explaining procedures, anesthetics and technology, so that the every-day individual can follow along and appreciate the art of anesthesiology. Any patient can read this book and be amazed at the genius of our ancestors; and the time and work required to acquire the knowledge and skill by the anesthesiologist, nurse anesthetist, anesthesiologist assistant, anesthesia technologist, and many other perioperative team members who get individuals of all ages and health safely through the perioperative process. Everyone ‘medical or non-medical’ will read this book and realize that anesthesia is not synonymous with sleep, and that while under the effects of anesthetics many monitors, medications, machines and people are needed to keep them alive and well. I especially enjoyed chapter 11 as Dr. Mets walks us through Valentine’s Day in the operating room complex at one of my favorite places, Penn State University Hershey Medical Center. Since I am so familiar with the surroundings, I could easily visualize the O.R. and the people as he describes the effort and coordination required to get dozens of patients safely through surgery on one of the most important days for romantics. On that day he gave a flawless anesthetic for a gynecologic procedure utilizing DaVinci robot. His skill assured that his patient, Jill would “Wake Up Safe” after the anesthetic to the delight of her husband, Jack. “Jack and Jill”, therefore, went home soon afterwards very happy with their anesthesia care. In closing, I recommend this book to anesthesiologists, students and the curious patients who want a better understanding of what anesthesiology really is, and where it came from, as well as one man’s journey to reach the peak of an anesthesia career. By the way, the book ends with a glimpse of the future of anesthesiology, or maybe its end; and the dawn of perioperative medicine.

The Pennsylvania Society of Anesthesiologists Newsletter |

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$200 Million JUA Raid Found Unconstitutional by Federal Court

Charles I. Artz, Esq. PSA GENERAL COUNSEL

We hold that the Joint Underwriting Association is a private entity, and its surplus funds are private property. The Commonwealth cannot take those funds without just compensation.

We find Act 44 to be an unconstitutional taking of private property in contravention of the Fifth Amendment to the United States Constitution.

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Chief Judge Christopher Conner of the federal court in Harrisburg issued a final decision imposing a permanent injunction and finding Act 44 of 2017 unconstitutional. Under Act 44, the Joint Underwriting Association (“JUA”) was forced to transfer $200 Million of its surplus and excess funds into the Commonwealth’s General Fund by December 1, 2017. If it refused to do so, Act 44 stated that the JUA would be abolished. The JUA filed a lawsuit in federal court after Act 44 was signed into law and requested a temporary injunction and a permanent injunction. In an earlier Opinion, Judge Conner imposed a preliminary injunction to prevent the law from going into effect. In Pennsylvania Professional Liability Joint Underwriting Association v. Wolf, ___ F.Supp.3d ___ (M.D. Pa. 2018) (2018 WL 2263549), decided May 17, 2018, the federal court issued a lengthy opinion summarizing the implications of Act 44, addressing the state government’s defenses, and finding the statute unconstitutional. Act 44 would have forced the transfer of $200 Million from the JUA into the General Fund to balance the state budget. Act 44 repealed Act 85 of 2016, which would have also effectively taken the $200 Million from the JUA, but had a repayment provision. Act 85 of 2017 had no repayment provision. The JUA sued under several U.S. Constitutional theories, including violation of the Takings Clause under the Fifth Amendment to the U.S. Constitution. The Governor and the General Assembly raised numerous defenses. In response to the government’s contention that the JUA was a public entity, the court held as follows: The [JUA’s] function is inherently private. It is, at its core, an insurance company. The [JUA] is comprised of private insurer members, governed by a private board, and supported by private employees. It is funded by privatelypaid premiums and is tasked to provide medical malpractice coverage to private persons practicing medicine within the Commonwealth. It does not exist wholly to serve the state, nor is it engaged in work otherwise tasked by statute to the state’s insurance commissioner. ***** We hold that the Joint Underwriting Association is a private entity, and its surplus funds are private property. The Commonwealth cannot take those funds without just compensation. On the ultimate constitutional issue, the federal court held as follows: The [JUA] is a private entity, and monies in its possession are private property. Act 44 endeavors to take a substantial portion of these funds – $200 Million – for the public purpose of remedying longstanding imbalances in the Commonwealth’s budget. Act 44 not only fails to provide just compensation; it fails to provide any compensation whatsoever. We find Act 44 to be an unconstitutional taking of private property in contravention of the Fifth Amendment to the United States Constitution. After finding Act 44 and the raid on the JUA unconstitutional, the court addressed the JUA’s request for a permanent injunction. This required the JUA to prove it will suffer irreparable injury without an injunction; legal remedies are inadequate to compensate that injury; the hardships of the parties warrant this type of remedy; and the public interest is not disserved by an injunction. The court held as follows: We have already determined that the constitutional injury effected by Act 44 is irreparable. *****

SENTINEL | The Pennsylvania Society of Anesthesiologists Newsletter


There is no adequate legal remedy to compensate JUA’s injury. ***** Act 44 effects a direct loss of $200 Million to the JUA as well as the indirect loss of both the interest on those funds and the cost of liquidating its investment portfolio. It inflicts a considerable and irreparable constitutional injury which far surpasses the General Assembly’s frustration in returning to the budgetary drawing board. As concerns the public interests, we do not doubt that the General Assembly’s intention was as stated – to achieve the estimable goals of balancing the state’s budget and providing for the health, welfare and safety of the residents of this Commonwealth. As we have already held, the General Assembly cannot achieve this legitimate end through illegitimate means. The public interest is furthered – not disserved – by permanently enjoining enforcement of a plainly unconstitutional statute. We will grant the Association’s request for permanent injunctive relief. The court concluded that the General Assembly, through Act 44, attempted to take by legislative requisition the private property of a private association to remedy its perpetual budgeting inefficacies. This it cannot do. Act 44 is plainly violative of the Takings Clause of the Fifth Amendment to the United States Constitution. The court granted summary judgment, declaratory judgment and permanent injunctive relief to the JUA. Under this ruling, the government cannot use the JUA’s funds to offset any budget deficits. This is a resounding victory for the JUA and physicians who, for whatever circumstances, are forced to participate in the JUA through payment of premiums and professional liability insurance coverage.

Go to www.psanes.org/job-bank for details The Pennsylvania Society of Anesthesiologists Newsletter |

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LEGISTLATIVE UPDATE

Kevin Harley

QUANTUM COMMUNICATIONS

From Left: PSA President Tom Witkowski, M.D., FASA; Shannon Grap, M.D.; Rep. Jim Christiana; Richard O’Flynn, M.D., FASA

House Professional Licensure Committee hearing

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The Fall election and gubernatorial race is influencing the state budget deliberations as the governor and members are looking to avoid a long, protracted budget stalemate which characterized the first three years of the Wolf Administration. Each of the 203 House of Representatives seats will be on the ballot, while 25 of the 50 senate seats are on the ballot. The budget has been described as an election-year budget without a significant increase in spending or revenue. PSA’s legislative agenda has been busy with supervision and balance billing legislation, including a hearing on the supervision bill in the House. SUPERVISION Legislative hearing on supervision of anesthesia bill. The House Professional Licensure Committee held a hearing on April 18 on HB 789. PSA supports legislation that would require a physician to supervise the administration of anesthesia in a hospital. Rep. Mark Mustio, chairman of the Professional Licensure Committee, who is committed to the legislation, called for the hearing. Rep. Mark Mustio said the work of the committee is “nonpartisan” and called on members to work on issues together for the safety of Pennsylvanians Rep. Jim Christiana, the prime sponsor of the legislation, said that his bill is not new public policy, as the text of the bill has been in effect through regulation for decades. He said his legislation is necessary to codify the regulation of anesthetists because there is an effort to change the dynamic in the operating room as it relates to the teamwork atmosphere. Any such change, he said, should be by act of the legislature because it would be such a substantive public policy change that it could affect public safety or public health. Speaking for PSA were Dr. Tom Witkowski, president; Dr. Richard O’Flynn and Dr. Shannon Grap. Dr. O’Flynn underscored the importance of patient safety and emphasized the importance of the language “under the supervision of the operating physician or anesthesiologist.” He said DOH is undertaking a review of the regulations and considering changes, and he noted that nurse anesthetists are seeking authority to administer anesthesia without supervision. Dr. O’Flynn told the committee, “The nurse anesthetists’ desire to take physician anesthesiologists out of the current ‘physician-led’ team approach would be wrong on many levels. Doing so would amount to an indefensible shortchanging of wellestablished medical protocols emphasizing patient safety.” He debunked the argument that removing physician supervision is necessary due to a shortage of physicians, stating that 97 percent of PA hospitals are staffed by physician anesthesiologists, and that 100% of anesthetics are performed under the supervision of a physican. Dr. Grap explained that things change quickly in the operating room. She said that within the care-team model she is present for all key components of the procedure and intermittently follows the patients so she can react quickly if necessary. She said while the majority of cases she oversees are elective surgery, even in those situations things can happen because patients are in a medicine-induced coma. She said she is always prepared for things to go wrong, even in very routine cases, and remains prepared for potential events. Members of the committee asked many questions about limits on the number of operating rooms an anesthesiologist can supervise, the distinction between the terms “supervision” and “collaboration,” the availability of anesthesiologists throughout the state and whether supervision may be delegated.

SENTINEL | The Pennsylvania Society of Anesthesiologists Newsletter


Dr. Grap explained that in her practice, she supervises CRNAs and anesthesia fellows and said she would not delegate supervision to them. An example of delegating responsibilities, she explained, would be if she stepped out to see another patient and the CRNA remained in the room. She said she does not delegate supervision, but may delegate the next task. Dr. Witkowski addressed committee members’ questions about the more extensive training completed by anesthesiologists as compared to CRNAs and, along with Drs. O’Flynn and Grap, fielded questions about the difference in risk associated with patients treated in surgical centers vs. hospitals. After PSA testified, representatives of the Pennsylvania Association of Nurse Anesthetists and American Association of Nurse Anesthetists presented their views on the issue, which essentially is that there is no difference in outcome when a CRNA administers anesthesia as compared with a physician and that the legislation is not necessary. Rep. Bill Kortz, Democratic vice chair of the committee, pointed out that the bill codifies current regulations and asked the CRNAs if they were suggesting that anesthesiologists are not needed. The CRNA representatives said, given the increased demand for anesthesia services, they would suggest an “all-hands-on-deck” approach and argued for hospitals to decide what they need. We anticipate legislative activity in the next few months on the supervision bill in the House. Legislation (HB 789), introduced by Rep. Jim Christiana and supported by PSA, places into the Medical Practice Act current Department of Health Regulations that require a physician to supervise the administration of anesthesia in a hospital. In the Senate, companion legislation (SB 960), was introduced by Sen. Tom Killion. We continue to gain support in the Senate as we work to educate the members the on the importance of patent safety. BALANCE BILLING Balance billing legislation continues to be an active issue in the House of Representatives. PSA remains a key member of the coalition made up of hospital specialists and the Pennsylvania Medical Society known as the Pennsylvania Coalition of Out-of-Network Services. The coalition-proposed language: • Establishes an equitable payment process that takes the patient out of the middle. • Uses the 80th percentile of charges from a nonprofit, third-party benchmarking claims database — such as Fair Health — to determine the payment for an out-of-network provider.

• Provides for a streamlined and impartial dispute resolution process. The latest draft of the bill, authored by the House Health Committee staff, calls for using a benchmark rate of 150 percent of Medicare or the in-network rate, whichever is lower. It also has a complicated payment process that doesn’t take the patient out of the middle. During a recent stakeholder meeting, our coalition pointed out that the only state in that nation to adopt a balance billing Medicare default rate is California at 125 percent. The coalition is unified in its opposition to using a 150 percent Medicare rate and we are continuing to meet with Republican House leaders and other members to change the language. The Senate, which has its own version balance billing legislation, has not taken any action on the issue. FENTANYL RESTRICTIONS In an effort to curb fentanyl overdoses, Rep. Bryan Barbin introduced HB 1987 which would restrict the use of fentanyl to surgery and hospice centers. Rep. Michael Schlossberg offered an amendment in the House Health Committee that allows fentanyl to be used in the management of pain for cancer, medical emergencies, and where in the professional medical judgment of the prescriber fentanyl is required to stabilize a patient’s acute medical condition with a limited seven-day supply. An additional amendment was offered on the floor by Rep. Jesse Topper that allows a physician to prescribe in the treatment of chronic pain not associated with cancer. The bill passed the House unanimously and is now in the Senate for consideration. ADVOCACY This time of the year is the busiest time for the legislature. We need your help as supervision and balance billing activity heats up in the legislature. Our success depends on members of the General Assembly hearing from you. As a PSA member, you are the strongest lobbying voice we have. Please make an effort to get to know and talk with your state senator and representative.

If you would like Quantum to help arrange a visit with your senator or representative, please contact us 717-213-4955.

The Pennsylvania Society of Anesthesiologists Newsletter |

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Chest Wall Blocks By David A. Goodman, MS , MD

UNITED ANESTHESIA SERVICES, PC ABINGTON SURGICAL CENTER I have been performing chest wall blocks as described by Blanco1,2,3 since 2014. The PECS1 block is performed between the Pectoralis major and minor muscle utilizing ultrasound at the T3 or T4 level. The PECS2 block incorporates the PECS1 and adds another injection between the Pectoralis minor and Serratus muscle. The Serratus plane block is performed around T6 in the midaxillary line between the Serrratus muscle and Latissimus muscle. There is very little literature on the patient response to these blocks. I would like to describe my progression through the different types of blocks for breast procedures. The reported results include any intraoperative narcotics, PACU narcotics, and next day follow up phone call. I personally performed all of the blocks while intraoperative narcotic administration was left to the discretion of the CRNA based on changes in hemodynamics. All procedures, except port placement, were done under General Anesthesia with LMA with blocks performed after induction. Initially, only patients of a single plastic surgeon participated, but as results and patient satisfaction became known, it became standard practice for all breast procedures. Most of the surgeons also work at other hospitals that until recently, did not perform these blocks. I constantly received anecdotal feedback from them of the difference in their patient’s outcomes. The initial experience dealt with patients getting breast reductions, implants, tissue expander removal and implant, or revision of post-surgical correction after mastectomy. The initial blocks in 2014 were all either PECS2 or Paravertebral. Paravertebral blocks were utilized after a patient who had prior radiation had a PECS2 and developed an axillary block and not a PECS2 block. Even though it appeared that she had tissue planes, and we could witness the medication going in, the distribution of the medication ended up being primarily axillary. Therefore, any patient who had a history of local radiation therapy received paravertebral blocks until I read about the serratus plane block at the end of 2016. This has since replaced the paravertebral in conjunction with other supplemental blocks. In 2017, I added the Pectointercostal block4 which has to significantly helped alleviate the frequent complaint of nipple pain when the rest of the breast area was pain free. This block consists of placing the medication in the tissue plane between the intercostal muscle and the Pectoralis major just lateral to the sternum. All blocks are performed with the maximum concentration of Bupivacaine + Epi based on the patient’s size. PECS1 15ml. PECS2 20ml between PECS minor and Serratus, 10ml between PECS major and minor. Serratus plane 20ml. Pectointercostal 10ml. Mid 2017 I started to also preop all breast patients with PO Tylenol 1000mg. Most patients also receive IV Toradol at the end of the procedure or in PACU. PACU narcotics were given if the patient’s pain was greater than 5 and they wished to receive a narcotic (some did not). Most patients were prescribed either Percocet or Vicodin by their surgeon if needed post op.

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The chart above shows the results of my progression. The 2018 data is for January and February only. We have also started to do many more implant removals for breast implant syndrome. As you can see, as we changed from PECS2 to performing the combination of Serratus Plane + PECS1 for cases that involved lower breast work such as reductions and removals with capsulotomies, the number of patients with severe post op pain went to zero. With the introduction of the Pectointercostal block in 2017, the percent of patients needing PACU narcotics also decreased. Too few patients have been done in 2018 to see if this trend will continue. Currently the following combinations of blocks are performed for the specified procedures: • Port placement PECS1 • Mastectomy PECS2+Pectointercostal • Augmentation PECS2+Pectointercostal • Reduction Mammoplasty Serratus Plane+PECS1+Pectointercostal • Tissue expander removal +Implant Serratus Plane+PECS1+Pectointercostal • Implant removal + capsulectomy Serratus Plane+PECS1+Pectointercostal The author would highly recommend that those who are teaching residents include these blocks for chest surgeries. I have heard when I am at conferences that the surgeon’s get upset if “we hold them up”. My answer to them would be that their residents hold up the schedule closing every case and we tolerate their learning. That is why you practice at a teaching hospital and are not in private practice. Teaching our residents what they need to know once they are done their residency is important. Ultrasound guided blocks fit into that mold. If you are at a teaching hospital and not doing this, you are doing our future colleagues a huge disservice. References 1 Blanco R: The “Pecs Block”, a novel technique for providing analgesia after breast surgery. Anesthesia 2011; 66:847-848. 2 Blanco R, Fajardo M. Parras Maldonado T: Ultrasound description of Pecs II (modified Pecs 1): a novel approach to breast surgery. Rev EspAnestesiolReanim 2102; 59:470-475 3 Blanco R: UltrasoundBlock.com Thoracic wall (PECS) blocks 11/30/2013 4 de la Torre, Patricia Alfara et. Al.: A novel ultrasound-guided block: A promising alternative for breast analgesia. Anesthetic surgery Journal 2014; Vol 34(1)198-200.

The Pennsylvania Society of Anesthesiologists Newsletter |

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Drug Costs, Drug Shortages and Group Purchasing Organizations Robert Campbell, M.D., Chairman | PHYSICIANS AGAINST DRUG SHORTAGES

Robert Campbell, M.D. and Senator Bill Cassidy, MD of Louisiana

Robert Campbell, M.D. and FDA Commissioner Scott Gotlieb, MD

President Donald Trump on lowering the cost of prescription drugs at the May Rose Garden Speech said, “We’re very much eliminating the middlemen. The middlemen became very, very rich. Whoever those middlemen were—and a lot of people never even figured it out—they’re rich. They won’t be so rich anymore.”

Throughout 2008 America endured an unprecedented year-long financial crisis. The financial infrastructure of the wealthiest nation in the world unraveled week by week, and month by month. It was not until years after the financial marketplace collapsed that experts determined the root cause of the collapse. Collateralized Debt Swaps (CDS), mysterious secret contracts authored by obscure financial middlemen, were identified as the fundamental cause of this financial calamity.

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In 2018, history may be repeating itself. The healthcare marketplace is plagued by similar contracts of mass destruction promulgated by secretive middlemen. They are not really middlemen in the truest sense of the word. They do not have capital at risk or inventory of any kind. They mostly write contracts for kickbacks. Why? Because in the healthcare supply chain, Group Purchasing Organizations (GPOs) and Pharmacy Benefit Managers (PBMs) have a unique ability to do so. They have a Safe Harbor for Kickbacks which allows them to do this without the usual criminal penalties. The GPO/PBM Safe Harbor is an unfortunate government inducement for good people to do bad things. Like Collateralized Debt Swaps of 2008 not many people know much about GPO or PBM contracts in 2018. Still physicians and patients would do well to learn about these things. The author was fortunate to be invited to the White House Rose Garden for President Trump’s long promised prescription to lower the cost of medications. He went off from the prepared teleprompter text one time when he said, “We are very much eliminating the middlemen. The middlemen became very, very rich right? Wherever these middlemen are. And a lot of people never even figured it out. They are rich. They will not be so rich anymore.” He is right. So now let’s try to understand his slightly cryptic language. The Big Four GPOs are Vizient, Premier, Healthtrust, and Intalere. The Big Three PBMs are CVS Health, Express Scripts, and Optum RX .These companies never reveal their secret contract terms with suppliers, insurers, hospitals, and pharmacies. There are clues about the scale of the problem. Pharmaceutical manufacturers which do research and create new patented medications have a trade group called PhRMA. They are the 35 largest research manufacturers. Their members pay “Rebates” to get through the GPO and PBM Middlemen. “Rebates” is an inside the beltway euphemism for legalized kickbacks. Legalized by one precious Safe Harbor for GPO/PBM Kickbacks. Apparently in the first survey of its kind they have discovered its members paid $144B last year in Kickbacks….I mean “Rebates”. That kind of yearly outlay could cure Alzheimers or Diabetes. Instead it simply is siphoned off and raises the cost of medications. 37% of patent medication cost is kickbacks. Patients pay them one way or another via insurance premiums, co-pays, or tax dollars for Medicaid and Medicare programs. In 2019 the projection is for 47% of the cost of patent medications to be kickbacks. Generic medications are also profoundly affected. Pay-to-

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play arrangements make it so only one or two companies must pay to gain access to their customers on the other are permitted to make certain drugs. So Mallinckrodt is side of the GPO/PBM paywall. The cumulative evidence the exclusive manufacturer for acthar which makes a $40 suggests well over $200B in healthcare cost savings 1952 generic molecule cost $40,000 per month. Baxter by cutting out the middleman kickbacks. This does not makes salt water for $545 per bag and nitroprusside include the incalculable financial benefits of restoring is $1,245 per dose. Mylan makes epi-pens with no freedom to the marketplace for suppliers to compete. competition for $850 per dose. Sole source contracts If these funds were re-directed from the pockets of compel companies to pay huge kickbacks. In return no businessmen and the campaign coffers of politicians competitor is permitted. Sole source contracts are the and used instead for healthcare some interesting reason we have generic drug shortages. It is not really things would happen. The Association of Community complex at all. Pharmacists projects outpatient prescription costs would Restructuring the healthcare supply chain is the essential fall by one third if rebates are eliminated. Hospital costs first step in any plan to make healthcare affordable again. and insurance premiums would fall. Medical device The Big Four Group Purchasing Organizations GPOs write and generic drug manufacturers would experience a contracts for over 90% of hospital drugs, supplies and renaissance in their businesses. Capital investment for medical devices. They offer companies the opportunity to new manufacturing plants in America would result in “Pay-to-Play” if the price is right for sole source contracts. thousands of high paying American jobs. Sometimes two companies are allocated market share. The middle class does not have to disappear. It is time for With only one or two manufacturers and only four buyers kickbacks to disappear and the American middle class to this creates a fragile supply chain resulting in pervasive re-appear. Of course, all of these financial calculations do shortages of hospital medications since 2006. not include any calculation of the human toll exacted by In 2017 there were 146 new drug shortages, mostly the many hundreds of medications in short supply or not generics, and many vital. Generic medications should be available at all. Cardiologists inserting temporary pacemakers inexpensive and plentiful. They are neither. Some drugs because the hospital has no bicarbonate. Bad care. No spinal come off the shortage list anesthetics. Bad care. Out of because contractually permitted There is no path to affordable, high Fentanyl. Bad care. companies increase production. cost of healthcare is beyond quality healthcare until free-market The Other times the drug comes the reach of too many middleoff the shortage list because competition is restored to the class Americans. Repealing the permitted companies drug/medical supply marketplace. the GPO/PBM Safe Harbor for discontinue manufacturing. Kickbacks will fix this problem. Then the drug is gone A bill is already written and altogether. This has happened frequently. Physicians Against Drug Shortages is doing what it can to Prior to 1991 GPOs were small, low revenue companies get it introduced. that served hospitals and were not permitted to demand Mid-term elections are approaching. Politicians will need to kickbacks from manufacturers. In 1991 GPOs experienced make themselves available to their voting constituents. The their Big Bang moment and received permission from theme for the mid-term elections should be let doctors and Congress and Health and Human Services (HHS) to collect patients join together to save healthcare. Physician-driven kickbacks. Suddenly the revenues of GPOs exploded. and patient-centered Healthcare Town Halls will be coming Healthcare costs soared. to many communities. If you wish to host one just let me The Big Three Pharmacy Benefit Managers (PBMs) also know. I anticipate 60 in 60 different districts nationwide, but write secret contracts for over 80% of all outpatient we may have even more. Repealing this Very Unsafe Safe prescriptions. They were modest-sized companies until their Harbor will be item number one for discussion. Big Bang moment in 2003 when the GPO Safe Harbor was There is no path to affordable, high quality healthcare until inexplicably extended to PBMs. Now PBMs happily join GPOs free-market competition is restored to the drug/medical in ruling over the healthcare universe controlling the entry supply marketplace. This is possible only if Congress and pricing for the healthcare supply chain for nearly all repeals the GPO/PBM Safe Harbor for Kickbacks. Find outpatient prescription drugs. Kickbacks are a percentage out if your Congressmen are in favor of unaffordable of revenue so inflationary incentives prevail. This explains healthcare kickbacks or opposed. Both Pennsylvania how in 2000 Americans’ prescription drug costs were Senators Casey and Toomey are briefed and are in favor $121B and in 2017 $360B. PBMs enjoy extraordinary profit of kickbacks. Repeal could be “disruptive” to the market. margins. Thus, the rush to either buy one or be bought by That is the goal, Senators. Pennsylvanians deserve better. one in the marketplace. Merger mania! Replace the broken marketplace with a new competitive Generic pharmaceutical companies and medical device market that works and lowers costs for patients. What a manufacturers have not disclosed just how much they perfect issue for physicians to assert leadership! The Pennsylvania Society of Anesthesiologists Newsletter |

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The Checklist Effect “…that may bring the biggest value in saving lives: by paring down and focusing not on saying ‘we’re going to solve all of it’, but rather ‘let’s bring the basic accomplishments of the 19th century – safe anesthesia, and then infection reduction – to our patients around the world’… But how can we do it?”

Gordon Morewood, MD, MBA, FASE PROFESSOR AND CHAIR, DEPARTMENT OF ANESTHESIOLOGY, LEWIS KATZ SCHOOL OF MEDICINE AT TEMPLE UNIVERSIT Y, ANESTHESIOLOGISTIN-CHIEF, TEMPLE UNIVERSIT Y HEALTH SYSTEM

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The recorded words of surgeon and author Dr. Atul Gawande settled over the assembled crowd. The medical students, anesthesiologists, surgeons and nurses gathered had all made the journey to the Kimmel Center’s Perelman Theater in the heart of Philadelphia’s Center City district. The purpose was a special screening of the award-winning documentary, The Checklist Effect. The film had been commissioned by the Lifebox Foundation several years earlier. Lifebox is an international non-governmental organization and the only such organization focused solely on improving surgical care around the globe. The charitable organization was formed in 2011 in a cooperative effort by the Brigham and Women’s Hospital, the Harvard T.H. Chan School of Public Health, the Association of Anesthetists of Great Britain & Ireland, and the World Federation of Societies of Anesthesiologists. In the seven years since, the Foundation has distributed more than 15,000 durable battery-powered pulse oximeters throughout 100 countries and trained over 5,000 healthcare professionals in team-working skills for the operating room. The June 16th event at the Kimmel Center had been organized with two purposes in mind. First, to illustrate the central nature of communication and teamwork in the delivery of safe patient care, particularly in high-risk healthcare settings. Second, to raise awareness of, and funding for, the mission of the Lifebox organization. The documentary film was preceded by an introduction by Dr. Alex Hannenberg, Past President and current Chief Quality Officer for the American Society of Anesthesiologists. As a Trustee for Lifebox he provided an overview of past successes and the Foundation’s strategic goals for the future. Interested PSA members can learn more at http://www.lifebox.org Following the film’s screening, a panel of healthcare experts took to the stage to discuss their experiences training surgical teams, both in the Philadelphia region and overseas. The group included two anesthesiologists, four surgeons, an operating room nurse and a nurse practitioner (see sidebar). Together they recounted decades of hard earned wisdom and first-hand experiences involving surgical care in resource constrained environments throughout the world. The evening was a significant success, both from the perspective of its educational mission and in terms of raising awareness for the Lifebox Foundation. The Pennsylvania Society of Anesthesiologists played a visible leadership role, contributing as an underwriter for the event and earning prominent billing in the program and during the introductory remarks. On behalf of the host committee, we would like to extend our thanks to the members of the PSA for their support of the event and the Lifebox Foundation. On my own behalf, I would like to convey my pride in belonging to a professional organization whose mission has so consistently centered on championing the safe care of surgical patients since its founding in 1948.

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Amanda Burden, MD Associate Professor of Anesthesiology Vice Chair of Faculty Affairs Director Clinical Skills and Simulation Cooper Medical School of Rowan University Cooper University Hospital Patricia Bailey, MD General Surgeon at Chestnut Hill Surgical Associates at the Women’s Center Kathleen J Dunleavy, RN, BSN, CNOR OR Nurse, The Children’s Hospital of Philadelphia

HOST COMMITTEE From Left: Moderator – Liz Drum; Panelists – Rodger Barnette, Owen Montgomery, David Low, Patricia Bailey, Eric Gokcen, Amanda Burden, Missy Duran, Kathleen Dunleavy

PANELISTS

Owen C. Montgomery, MD, NCMP Professor and Chairman Department of Obstetrics and Gynecology Drexel University College of Medicine Eric C. Gokcen, M.D. Associate Professor of Orthopaedic Surgery Director, Division of Foot & Ankle Surgery Department of Orthopedic Surgery & Sports Medicine Temple University Rodger E. Barnette, MD, FCCM Consultant Anesthesiologist & Intensivist, AIC Kijabe Hospital, Kijabe, Kenya Emeritus Professor, Temple University

Melissa (Missy) Duran, MSN, CRNP, NNP-BC Newborn/Infant Intensive Care Unit The Children’s Hospital of Philadelphia David W. Low, MD Professor of Surgery Division of Plastic Surgery Perelman School of Medicine at the University of Pennsylvania Clinical Associate, The Children’s Hospital of Philadelphia Attending Surgeon, Hospital of the University of Pennsylvania

Gordon Morewood, MD, MBA, FASE Chair, Department of Anesthesiology Temple University Elizabeth Drum, MD Medical Director of Anesthesia / Sedation Services The Children’s Hospital of Philadelphia Rebecca Barnett, MD Senior VP, Medical Director for Perioperative Services Thomas Jefferson University Hospitals Michael Green, DO Chair, Department of Anethesiology& Perioperative Medicine Drexel University Daniel Dempsey, MD Assistant Director, Peri-Operative Services The Hospital of the University of Pennsylvania

There have been drug shortages since 2006 There is skyrocketing inflation for all medications Americans are paying more money for less healthcare Something is happening here! What it is isn’t exactly clear, unless…. YOU ARE A MEMBER OF

NO JUST CDUES, LARIT Y A AWARND ENESS

Physicians Against Drug Shortages

JOIN NOW. www.PhysiciansAgainstDrugShortages.com The Pennsylvania Society of Anesthesiologists Newsletter |

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Physician Convicted By Federal Jury Of Illegally Sharing Patient Medical Files Charles I. Artz, Esq. PSA GENERAL COUNSEL

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A new federal court case in which a physician was convicted in federal court for violating the HIPAA Privacy regulations is important to consider for compliance purposes and in the context of physicians’ interaction with pharmaceutical sales representatives. This decision is particularly applicable to PSA Members who practice pain management and may be subjected to marketing efforts by pharmaceutical sales and marketing representatives. In U.S. v. Luthra, No. 15-cr-30032-MGM (D. Mass. 2018), Dr. Rita Luthra, a 67-year-old physician, was convicted by a federal jury for violating the Wrongful Disclosure of Individually Identifiable Health Information criminal provision under the HIPAA Privacy statute, 42 U.S.C. §1320d-6, because she asked a pharmaceutical company’s sales representative to help her medical assistant with securing prior authorizations for expensive medications marketed by the pharmaceutical company without signing a Business Associate Agreement. The pharmaceutical company aggressively marketed the physician to order a new drug which was not on most insurance plans’ formularies, primarily because a far less expensive generic drug was available. The insurance plans would not pay for the new drug unless the physician submitted a prior authorization request explaining why the patient needed the new drug instead of the generic or another less expensive equivalent. When the physician began writing prescriptions for the new drug, she started receiving numerous denials from insurance companies. Because the volume of denials coming into her office was significant, the physician asked the sales representative to help her staff secure prior authorizations. The sales representative agreed. In the course of helping the physician’s staff secure prior authorizations from the insurance companies, the pharmaceutical marketing representative had access to the physician’s patients’ PHI and used the PHI to prepare the prior authorizations. Because PHI was disclosed without a BAA for the physician’s economic gain, the HIPAA Wrongful Disclosure criminal statute was violated. According to the federal court documents in the case, the physician was a highvolume prescriber of inexpensive medications. The pharmaceutical manufacturer targeted her in an effort to switch her prescriptions to the pharmaceutical company’s new drug. The marketing representative told the physician she could get paid by the pharmaceutical company and she could earn speaker fees by simply talking to the marketing representative in her office. The pharmaceutical company paid her $23,500 for speaker training and 31 “events,” which consisted of the marketing representative bringing her breakfast or lunch into the office and the physician talking with the marketing representative for about a half an hour while she ate. This induced the physician to change her prescribing habits and switch prescriptions to the pharmaceutical company’s new, expensive drug. When the government initiated an investigation ostensibly for violating the Anti-Kickback statute against the pharmaceutical company, the OIG began to investigate the physician as well. During an interview with the OIG agents, the physician lied to the OIG by telling the OIG agents that the marketing representative did not have access to patients’ PHI. The physician then told her

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staff to tell the OIG agents that PHI was not shared with the pharmaceutical marketing representative. The physician made matters worse by lying to the OIG agents a second time by telling them the pharmaceutical company paid her to read and opine on clinical research. The pharmaceutical company did not pay her to write a research paper. It only paid her to talk about medical and clinical issues with the pharmaceutical marketing representative. Based on these allegations, the physician was also convicted on one count of Obstruction of a Criminal Investigation of a Health Care Offense under 18 U.S.C. §1518. This criminal case is troublesome because the PHI disclosures without a BAA would ordinarily be dealt with by imposing a significant civil fine through the Office for Civil Rights. The case was obviously exacerbated by the pharmaceutical company’s free meals, coupled with bogus speaker fees in violation of the AntiKickback statute. Notably, the physician was not indicted or convicted of violating the Anti-Kickback statute; however, succumbing to the marketing pressures by the pharmaceutical company sales representative resulting in her switching prescriptions, needing help to secure prior authorizations from insurance companies, and requesting help from the same marketing representative who induced her in the first place, then lying to the OIG created the proverbial “perfect storm” leading to the criminal charges and conviction. This is only the second case in which a physician has been indicted and convicted for violating the HIPAA criminal Wrongful Disclosure of PHI statute. Given the gravity of the criminal exposure, please consider the following: 1. Some pharmaceutical manufacturing company marketing representatives will do just about anything to persuade and even induce physicians to switch prescriptions to their company’s more expensive drugs, including conduct that clearly violates the federal Anti-Kickback statute. 2. Be wary of and vigilant to reject pharmaceutical company sales representatives’ offers to provide free meals connected with compensation in the form of speaker fees, trips, sporting events and other offers of remuneration unless the work being done is absolutely legitimate to advance some clinical research that is actually used by the pharmaceutical company. 3. If an OIG agent investigating a pharmaceutical company in a kickback or other case appears at your office, advise physicians not to speak to the federal agents without legal counsel being present, and obviously never lie or tell anyone else to lie to federal agents. 4. Obviously, never disclose PHI to any person to secure prior authorization approval assistance or for any other work without executing a HIPAAcompliant Business Associate Agreement. Even though criminal indictments and convictions against physicians for violating the HIPAA Wrongful Disclosure criminal statute are rare, letting your guard down and getting paid a relatively small amount of money (such as the $23,500 in this case) can have a disastrous result. The Pennsylvania Society of Anesthesiologists Newsletter |

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LEGISLATIVE CONFERENCE 2018 Highlights Drug Shortages, Opioid Crisis

Erin A. Sullivan, M.D., D.ABA, FASA ASA DIRECTOR, PENNSYLVANIA AND CHAIR OF THE MID-ATLANTIC CAUCUS

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It has been another epic year for the protection of safe care for our patients and for the continued stewardship of our specialty! I was again inspired to be surrounded by so many consummate professional citizens at LEGISLATIVE CONFERENCE 2018, held in our Nation’s capital on May 14-16 at the Hyatt Regency Washington Capitol Hill. With more than 600 ASA members in attendance, of which more than 30% were residents, this year’s conference gave us the opportunity to congratulate one another on our successes, while building relationships and honing our advocacy skills to prepare for the future challenges that will impact our patients and our specialty across all levels of government. LEGISLATIVE CONFERENCE 2018 featured presentations on several topics of continued importance to physician anesthesiologists and our patients. The Interactive Workshop on State Advocacy highlighted a variety of legislative and regulatory issues that affect ASA members at the state level. In addition to special skill-based presentations focused on developing methods to engage state and local lawmakers, attendees learned about current legislation in several states pertaining to attempts to remove physicians from the care team, out-of-network payment issues, responsible tactics for engaging legislators and patients on social media and results from a recent research study that addresses questions about access to care and patient safety. Physician-Led, Team-Based Care for Veterans Protected, Preparation for Future Challenges In 2017, after more than three years of review and analysis, two comment periods generating over 200, 000 comments, and the engagement of over 140 members of Congress, VA rejected a proposal to replace physician anesthesiologists with nurse anesthetists in the VA hospitals. The decision preserved the physician-led, team-based model of anesthesia that has assured safe, high quality surgical anesthesia care for the unique patients of the VA. Legislative Conference 2018 attendees expressed their appreciation to members of Congress for supporting this initiative and urged them to oppose H.R. 1783, the “Improving Veterans Access to Quality Care Act,” which ignores the thorough debate from the public comment periods, disregards peer-reviewed independent studies, and places Veterans’ health and safety at risk. Reducing Patient Exposure to Opioids in the Surgical Setting The surgical experience can be a patient’s first exposure to opioids. For some patients, that exposure can ultimately lead to opioid abuse and misuse. Physician anesthesiologists have the unique medical knowledge and expertise to develop and utilize pain control alternatives that can reduce patient exposure and use of opioids during and after surgery. As Congress works to address the opioid crisis, it is critical that all aspects of the health delivery system be reviewed and challenged to reduce and limit the use of opioids including the surgical setting. ASA commends Congress for several initiatives aimed at reducing patient exposure to opioids and collection of data on best practices. • ASA strongly supports section 403 of the Senate HELP Committee reported bill, S. 2680, the Opioid Crisis Response Act which includes dedicated grants to hospitals and other acute care settings to implement best practices on the use of alternatives to opioids. • ASA strongly supports H.R. 5718, the Perioperative Reduction of Opioids Act introduced by Representatives Jason Smith (R-MO) and Brian Higgins (D-NY) to establish a U.S. Department of Health and Human Services Technical

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Expert Panel (TEP) directed at reducing opioids in the surgical setting and collecting data on perioperative opioid use. • ASA supports H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department, a bill moving through the House which is similar to section 403 of S. 2680. This bill could be expanded to incorporate the surgical setting. Severe Drug Shortages Impacting Patient Safety and Care In recent months, the U.S. has experienced unprecedented drug shortages. Of great concern to physician anesthesiologists are shortages of injectable anesthetics and intravenous pain medications. These drugs are critical to ensuring that patients are safe and that their pain is managed during surgical and other interventional procedures. Having a diminished supply or no supply of critical drugs at all can cause suboptimal pain control or sedation for patients, in addition to creating complex workarounds for the healthcare team, leading to potential errors. Shortages have also resulted in delays and even cancellation of care. Current drug shortages include local anesthetics (bupivacaine and ropivacaine) and intravenous pain medications (fentanyl, hydromorphone and morphine). Legislative Conference attendees emphasized that these intravenous pain medications should be distinguished from the oral opioid medications prescribed directly to patients since the injectable medications are prescribed and administered by physicians in the hospital and other acute care settings to prevent pain and supplement sedation during or after surgery. ASA has asked that Congress reexamine the issue of drug shortages and request that the Department of Health and Human Services convene key stakeholders such as the FDA, the DEA, DHS, manufacturers and Entire Pennsylvania Delegation during PSA visit to Senator Pat Toomey’s office’ organizations that represent end users such as the American Society of and Drs. Joseph Galassi and Bhaskar Deb Anesthesiologists for the purpose of developing long-lasting solutions to with PSA residents.) the drug-shortage crisis. Getting Involved in Advocacy Even if you were not able to participate in Legislative Conference 2018, you can still be involved in our advocacy efforts at the state and federal level. The ASA Advocacy Division has launched a series of advocacy modules to enhance the grassroots activities of its members as they promote patient safety and the specialty. As part of ASA Team 535, an initiative to have at least one strong relationship with all members of Congress, the modules are being rolled out in a series over the next few months. Members of ASA Team 535 are guided through the online advocacy modules as part of the program. At the conclusion of the module, members are prompted to answer three questions to ensure understanding of the material. Throughout the program, they are assisted with outreach to their representative and will be asked to meet with their lawmaker or staff at least once. At the conclusion, they will also verify their participation and interests with a personal phone conversation. ASA President James Grant, M.D., M.B.A., FASA, launched ASA Team 535 to continue to build on growing interest among physician anesthesiologists to be advocates for patient safety. ASA members who are interested in viewing the advocacy modules and joining ASA Team 535 can go to http://www. asahq.org/advocacy/advocacymodules Looking ahead, 2018 will be a massive election year at the state level, with 36 gubernatorial elections being held and legislative elections in almost every state including our own Commonwealth of Pennsylvania. These elected leaders and candidates will be looking for guidance on patient safety related initiatives. This is an opportunity that should not be overlooked. Your involvement is crucial to the continued preservation of patient safety and access to physician-led, teambased healthcare. Each year, the LEGISLATIVE CONFERENCE helps us to assess where we are and where we are going. To be sure, we have much success to celebrate. But I really love this conference because it serves as an important reminder that we must continue sharing resources and working together in order to secure the future of anesthesiology. Thank you to you, the attendees, for giving your valuable time and energy to advocate for our patients and our specialty. I look forward to seeing this high level of engagement continue through the coming years, when surely advocacy will be even more critically important to secure best practices and patient safety. The Pennsylvania Society of Anesthesiologists Newsletter |

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know your equipment...

INTRA-ARTERIAL BLOOD PRESSURE MONITORING Verghese Cherian, M.D., FFARCSI

ASSOCIATE PROFESSOR | DIRECTOR, DIVISION OF MULTISPECIALTY ANESTHESIA DEPARTMENT OF ANESTHESIOLOGY & PERIOPERATIVE MEDICINE | PENN STATE HERSHEY MEDICAL CENTER Intra-Arterial Blood Pressure (IABP) measurement has several advantages over a non-invasive blood pressure (NIBP) measurement. • A continuous beat-to-beat pressure measurement when close monitoring is indicated • The waveforms can provide information on the cardiovascular status (pulse contour analysis) • Allows frequent arterial blood sampling • Useful when NIBP measurement is difficult, e.g., burns or obesity • More reliable than NIBP in patients with arrhythmias or extreme hypotension Components of the IABP monitoring system The intra-arterial pressure monitoring system consists of a transducer connected through low compliant, salinefilled tubing to a 20-22G cannula inserted into the artery. A bag of heparinized saline, pressurized to 300 mmHg, is attached to the other end of the transducer and infuses saline through the system at 2-4ml/h in order to maintain the patency of the arterial cannula. The transducer is connected to the processor. The arterial pressure wave transmits through the fluid column and vibrates the diaphragm of the transducer which converts it into an electrical signal to be displayed on a monitor (Figure 1).

PHYSICAL PRINCIPLES Sine wave A sine wave is the depiction of movement of energy through a medium (Figure 2). It is described by its ‘amplitude’ or the maximum displacement; ‘wavelength’ or distance moved in one cycle; and ‘frequency’ or the number of cycles it lapses

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per second, known as ‘Hertz’ (Hz). Sine waves of differing amplitude and frequency can combine to form a complex wave. The process of analyzing a complex wave by splitting it into its constituent sine waves is known as Fourier analysis. A transducer measuring the arterial pressure should be able to detect all the component waves in order to give an accurate representation of the original waveform. Natural frequency and Resonance Every material when struck oscillates at its ‘natural’ frequency (fn) and this depends on physical properties of the material, such as density and thickness and also of the adjacent material. If an external force or a waveform, with a frequency similar to the natural frequency, is applied, the material would oscillate at its maximal amplitude and this is known as ‘resonance’. Therefore, if the natural frequency of the IABP monitoring system is close to the frequency of any of the components of an arterial waveform, it would vibrate excessively and distort the signal. Most commercially available arterial pressure transducers have a natural frequency of around 200Hz. However, the addition of 3-way taps and increased length and compliance of the tubing can reduce the natural frequency of the system. Damping The arterial pressure monitor, in addition to having a high natural frequency, also needs an appropriate damping coefficient (zeta or ζ). Damping can be construed as the force which brings the transducer system back to its resting stage after the oscillation in order to detect the next wave. Therefore a critical damping is essential for proper functioning of the system, and overdamping or

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underdamping would adversely affect the measurement. Underdamping leads to large amplitude oscillations and factitiously high systolic and low diastolic pressure readings, while the oscillations are blunted in an overdamped system with erroneously low systolic and a high diastolic pressure. However, in either situation, the mean arterial pressure may be accurate. In an IABP measuring system, the factors that impede fluid flow such as narrowing (kinks, vasospasm), obstruction (clots, air bubbles), or compliant tubing increase damping. The optimal damping coefficient of 0.7 provides the balance between rapid response and accuracy. ‘Fast flush’ test The flushing system can also be used to perform the ‘Fast flush’ test to calculate the natural frequency and the damping coefficient of the system. A short burst of flush is applied and the pressure waves are analyzed. The square wave corresponds to the exposure of the transducer to the 300 mmHg pressure of the flushing system. This is followed by sharp waves oscillating at the natural frequency of the system and it can be calculated by dividing the screen speed by the wavelength of the resonant waves. Therefore, the closer the oscillation cycles, the higher the natural frequency. Similarly, the ratio of the amplitudes of the second to the first post-flush waves (amplitude ratio) can be used to derive the damping co-efficient from standard nomograms. A low amplitude ratio corresponds to a high damping coefficient, or the system comes to rest quickly (Figure 3). CLINICAL SIGNIFICANCE Although the desired technical requirements for arterial pressure monitoring are a natural frequency greater than 25Hz and a damping coefficient of 0.7, these conditions are rarely met in routine clinical practice. Most catheter-tubing transducer systems are underdamped (damping coefficient of 0.15 to 0.45) and have an acceptable natural frequency of 12-25 Hz, especially if the heart rate is less than 90/min or 1.5Hz. Figure 4 shows the relationship between damping coefficient and the natural frequency of arterial pressure monitoring systems. There are five possible situations. 1. Adequate – accurate recording of most pressure waveforms seen clinically 2. Overdamped 3. Underdamped 4. Unacceptable – natural frequency <7Hz 5. Optimal If the natural frequency is low (10 Hz) then the damping coefficient should be between 0.45-0.6 or the system would resonate and record an erroneous wide pulse pressure. Transducer The IABP transducers use the physical principle that the electric resistance of a wire varies with its length to convert the pressure of the arterial wave into an electrical signal. The arterial pressure wave moves along the fluid column and displaces the diaphragm of the transducer. This displacement compresses and stretches the wire attached to the diaphragm and the change in resistance of the wire can be measured precisely and converted to the displayed intra-arterial blood pressure.

Summary The advantages of intra-arterial blood pressure measuring are close monitoring of blood pressure, especially when a non-invasive mode is unreliable, analysis of the arterial waveform, and ease to perform arterial blood gas analysis. However, an understanding of the working principles of the system, and knowledge of the common causes of error and ways to trouble-shoot it are essential to avail the maximum benefit of this extremely crucial monitoring mode.

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CLINICAL POINTS Practical Points about Transducer setup • It is crucial that all air bubbles are removed from the flushing system and the tubing before it is connected to the arterial cannula. The flushing system, pressurized to 300 mmHg, provides a continuous infusion of heparinized saline at 2-4ml/ h, which can also be used to flush the system after blood sampling. • Zeroing – The transducer must be exposed to the atmosphere and calibrated to read zero before it is exposed to the arterial pressure. This is done by turning the three-way stopcock adjacent to the transducer. Note that the level of the transducer in relation to the patient is not crucial for zeroing. • Levelling – The transducer must be set at the level of the heart (4th intercostal space, mid-axillary line) to measure the blood pressure accurately. This is the ‘phlebostatic’ axis. (Figure 6) If not, the hydrostatic pressure of the column of fluid would cause error. If the transducer is 10cm lower than the phlebostatic axis, the pressure would read higher, than actual, by 10 cm H2O or 7.5 mmHg. • If the position of the patient is changed for surgical access, the transducer should be re-positioned to the phlebostatic axis to obtain the correct blood pressure. (Figure 7) However, if one is interested in monitoring the pressure of the cerebral circulation (e.g. in a patient undergoing shoulder surgery in ‘beach-chair’ position), the transducer should be placed at the level of the tragus. References: Schroeder RA, Barbeito A, Bar-Yosef S, Mark JB Cardiovascular Monitoring. In Miller RD (Ed) Anesthesia 8th Edition, Elsevier Saunders, Philadelphia. 2015: 1345-1395 Jones A, Pratt O. Physical principles of intra-arterial blood pressure measurement. Anaesthesia Tutorial of the Week 2009; 137: 1-8

Congratulations to PSA members who demonstrated their dedication and leadership in anesthesiology by becoming a Fellow of the American Society of Anesthesiologists (FASA). The FASA designation is ASA’s highest acknowledgment that recognizes years of dedication to exceptional education, leadership and commitment to the specialty.

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Ward M, Langton J. Blood Pressure Measurement. Continuing Education in Anaesthesia, Critical care and Pain 2007; 7: 122-126 Cherian, V.T. and A. Budde, Physics of Instrumentation, in Basic Sciences in Anesthesia, E. Farag, et al., Editors. 2018, Springer: Cham, Switzerland. p. 597-612.

Joseph F. Answine, M.D., FASA Jeffrey Astbury, M.D., FASA Joshua H. Atkins, M.D., Ph.D., FASA Shawn Timothy Beaman, M.D., FASA Andrew Boryan, M.D., FASA Charles David Boucek, M.D., FASA Zyad J. Carr, M.D., FASA Edward H. Dench, Jr, M.D., FASA Elizabeth T. Drum, M.D., FASA James W. Heitz, M.D., FASA Andrew Herlich, M.D., FASA Donna A. Kucharski, M.D., FASA Kristin Ondecko Ligda, M.D., FASA William R. McIvor, M.D., FASA

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David Metro, M.D., FASA Richard Month, M.D., FASA Richard Paul O’Flynn, M.D., FASA Rita M. Patel, M.D., FASA Shailesh Patel, M.D., FASA Raymond M. Planinsic, M.D., FASA Muzammil Mahmood Qaisar, D.O., FASA Tetsuro Sakai, M.D., FASA Eric Schwenk, M.D., FASA Mark Shulkosky, M.D., FASA Erin Sullivan, M.D., FASA Michael Jon Williams, M.D., FASA Scott I. Winikoff, M.D., CPE, FASA Thomas A. Witkowski, M.D., FASA


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