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11COMMONWEALTH OF PENNSYLVANIA2DEPARTMENT OF STATE3BUREAU OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS45F I N A LM I N U T E S67MEETING OF:89STATE BOARD OF MEDICINE10VIA TELECONFERENCE1112TIME:10:30 A.M.1314Tuesday, July 28, 20201516171819202122232425Sargent's Court Reporting Service, Inc.(814) 536-8908
303132333435363738394041424344454647484950State Board of MedicineJuly 28, 2020BOARD MEMBERS:Keith E. Loiselle, Chairman, Public MemberK. Kalonji Johnson, Commissioner, Bureau ofProfessional and Occupational AffairsMark B. Woodland, M.S., M.D.Gerard F. Dillon, Ph.D., Public MemberRonald E. Domen, M.D.Walter A. Eisenhauer, PA-CRachel Levine, M.D., Physician General/Secretary ofHealthMary Pat Howard, M.S., RN-BC, Executive Assistantof Quality AssurancePaul J. Valigorsky II, M.D.Donald M. Yealy, M.D.BUREAU PERSONNEL:Dana M. Wucinski, Esquire, Board CounselShana M. Walter, Esquire, Board CounselJason T. Anderson, Esquire, Board Prosecution LiaisonCarolyn DeLaurentis, Deputy Chief Counsel, ProsecutionDivisionDean F. Picarella, Esquire, Senior CounselCodi M. Tucker, Esquire, Board ProsecutorKeith E. Bashore, Esquire, Board ProsecutorNathan C. Giunta, Esquire, Board ProsecutorMark R. Zogby, Esquire, Board ProsecutorAdam Williams, Esquire, Board ProsecutorAdam L. Morris, Esquire, Board ProsecutorDean F. Picarella, Esquire, Senior CounselCynthia K. Montgomery, Esquire, Deputy ChiefCounsel/Regulatory Counsel, Department of StateSuzanne Zerbe, Board AdministratorAndrew LaFratte, MPA, Policy Office, Department ofStateTheodore Stauffer, Executive Secretary, Bureau ofProfessional and Occupational AffairsElliott Zucker, Legal Extern, Office of GeneralCounsel, Pennsylvania Department of StateMarc Farrell, Deputy Policy Director, Department ofStateHolly Hoffman, Law ClerkSargent's Court Reporting Service, Inc.(814) 536-8908
303132333435363738394041424344454647484950State Board of MedicineJuly 28, 2020ALSO PRESENT:Bruce D. Armon, Esquire, Saul Ewing Arnstein & LehrM. Jason Asbell, Esquire, Gibbel, Kraybill, & HessJen Smeltz, Executive Director, Consumer Protectionand Professional Licensure CommitteeNicole Sidle, Majority Committee Executive Director,House Professional Licensure CommitteeWesley J. Rish, Esquire, Rish Law Office, LLCAngie Armbrust, Senior Associate, McNees-WinterGroup LLCSusan DeSantis, PA-C, Pennsylvania Society ofPhysician AssistantsKatrina Mulherin, Wanner AssociatesAndrew C. Harvan, Esquire, Pennsylvania MedicalSocietyEmily McGahey, MSN, CNM, Pennsylvania Association ofCertified Nurse-MidwivesLisa Claypool Stevenson, Senior Associate Counsel,University of Pittsburgh Medical CenterAli Aziz, Medical Student***Sargent's Court Reporting Service, Inc.(814) 536-8908
41State Board of Medicine2July 28, 20203***4[Pursuant to Section 708(a)(5) of the Sunshine Act,5the Board entered into Executive Session with Dana M.6Wucinski, Esquire, Board Counsel, and Shana M. Walter,7Esquire, Board Counsel, prior to the public meeting8for the purpose of conducting quasi-judicial9deliberations on a number of matters currently pending10before the Board and to receive the advice of counsel.1112The Board returned to open session at 10:30 a.m.]***13The regularly scheduled meeting of the State14Board of Medicine was held on Tuesday, July 28, 2020.15Keith E. Loiselle, Chairman, Public Member, called the16meeting to order at 10:30 a.m.17***18[Chairman Loiselle informed everyone that their19voluntary participation in the meeting constitutes20their consent to being recorded.]21***22[Chairman Loiselle stated everything discussed in the23meeting carries the same full force and effect as24though it was a typical meeting in Harrisburg]25***Sargent's Court Reporting Service, Inc.(814) 536-8908
51Roll Call2[Chairman Loiselle requested a roll call of Board3members.]4***5[Chairman Loiselle thanked all those involved in the6appointment of Dr. Gerard Dillon, Dr. Donald Yealy,7and Mr. Walter Eisenhauer as new members of the8Board.]9***10Report of Department of Health11[Rachel Levine, M.D., Physician General/Secretary of12Health, Department of Health, provided an update13regarding COVID-19, noting that it continues to14present a threat globally and nationally.15reported 109,384 cases of COVID-19 with 7,146 deaths16in Pennsylvania.17number of new cases we are seeing in Pennsylvania due18to increases in the rest of the country from summer19travel.20SheShe mentioned a steady rise in theDr. Levine stated cases are occurring primarily21in younger people in their late teens to 40s that have22been congregating in groups.23began in Allegheny County and surrounding counties,24noting signs of stabilization with mitigation factors25that Dr. Debra Bogen, Director of the Allegheny HealthShe noted increasesSargent's Court Reporting Service, Inc.(814) 536-8908
612Department, had put into place.Dr. Levine addressed mitigation orders3recommended by the Department of Health and Human4Services and the White House Coronavirus Task Force5that were implemented statewide less than two weeks6ago to help stabilize the increase.7Dr. Levine announced significant advances in8terms of treatment for patients with COVID-19 with9oxygen support and not requiring ventilation.She10mentioned a new method, where hospitals receive11remdesivir directly from the Department of Health and12Human Services.13convalescent plasma have been shown to be helpful for14severely ill patients.15She stated dexamethasone andDr. Levine noted that Dr. Deborah Birx, with the16White House Coronavirus Task Force, highlighted the17need to look at subtle increases in terms incidence18rates and number of new cases per day.19Dr. Levine addressed school openings and working20with the Pennsylvania Department of Education,21allowing schools to make their own decisions, while22recommending best practices.23Dr. Levine discussed long-term care facilities24and nursing homes, which bore the brunt of COVID-19 in25the northeast in the number of cases and deaths.Sargent's Court Reporting Service, Inc.(814) 536-8908She
71stated there are protocols in place to ensure they2have adequate personal protective equipment (PPE).3Dr. Levine reported 99.2% of nursing home4residents were tested, and they are working on the5other 1200 personal care homes and living centers.6Dr. Levine addressed the Reginal Response Health7Collaboration Program (RRHCP) led by the Department of8Human Services (DHS) and Department of Health (DOH)9involving academic medical centers working with10nursing homes and long-term care centers in terms of11PPE, infection control, and education.12Dr. Levine stated Pennsylvania was averaging1320,000 tests a day and hiring people to perform case14investigations and contact tracing in order to contain15the virus.16tracking is adequate testing and noted issues17regarding waiting times to get test results because18LabCorp and Quest Diagnostics are overwhelmed with19specimens.20reagents necessary for testing.21She commented that the hallmark ofShe mentioned shortages of chemicals andDr. Levine noted an increase of nurses statewide22to perform case investigations and an increase in23contact tracers to contact people who have been24exposed to a person for proper isolation and25quarantine.Sargent's Court Reporting Service, Inc.(814) 536-8908
81Dr. Levine announced the start of third-stage2clinical trials of some of the vaccines.3issues with how much of the vaccine Pennsylvania would4receive and who would receive it, noting there would5be different groups looking at that from an ethical6and practical point of view.7She reportedChairman Loiselle questioned whether antibody8testing would be increasing because they are9considered to be part of the overall paradigm moving1011forward.Dr. Levine stated antibody testing currently had12a limited role, noting there was not enough known13about what a positive antibody test means.14reported the Red Cross had been testing blood, and the15CDC had been getting blood from hospitals and health16systems and testing antibodies.17going to mean more from an epidemiological population18health point of view than clinically of whether you19have antibodies or not.20SheShe thinks it isDr. Levine noted concentrating on the polymerase21chain reaction (PCR) test, which are the22deoxyribonucleic (DNA) test.23importance of having an accurate point-of-care test24that could be done with a nasal swab or oral swab in2520 minutes as opposed to the nasopharyngeal swab.She mentioned theSargent's Court Reporting Service, Inc.(814) 536-8908
91Dr. Woodland noted over 12,000 cases of pregnant2women testing positive have been reported to the CDC3but only 165 of them have required ventilation.4mentioned it to be helpful to look at the maternity5implications in Pennsylvania. He noted seeing COVID in6a younger pregnant population in the hospital in which7he is employed, where there were 3 positive teenagers8under the age of 20 with COVID and admitted for9pregnancy-related issues but not COVID-related issues.He10Dr. Levine stated the DOH could collaborate with11obstetricians/gynecologists in academic medicine and12work on a data-sharing agreement but was not sure if13their team had the bandwidth to do a study.14Dr. Levine stated DOH would soon be publishing a15Morbidity and Mortality Weekly Report (MMWR), looking16at multisystem inflammatory syndrome in children (MIS-17C).18mostly in the southeast affecting more African-19American children and an older age group than with20Kawasaki disease.21She mentioned that Pennsylvania had 39 casesDr. Levine will mention it to Carolyn Byrnes, who22runs the Maternal Mortality Review Committee, to see23if she can reach out to the American College of24Obstetricians and Gynecologists (ACOG).25Commissioner Johnson questioned how the recentSargent's Court Reporting Service, Inc.(814) 536-8908
101efforts are going related to health disparities and2inequities.3Dr. Levine addressed health equity throughout4COVID-19, noting that the Health Equity Task Force5collaborated with the Lieutenant Governor’s task6force, which generated a number of different specific7recommendations.8terms of race with less in terms of ethnicity.9She noted being up to about 60% inDr. Levine emphasized the importance of10healthcare providers and laboratories marking the11field in the data system in terms of demographic12characteristics, where race and ethnicity are13critically important as well as sexual orientation and14gender identity (SOGI).15Dr. Yealy questioned whether there was any new16information regarding testing supplies and remdesivir.17Dr. Levine commented that swabs and media are18available from Health and Human Services and stored in19Harrisburg, but there are no stores of reagent.20noted a recent change, where hospitals now have to21report their census of patients with COVID-19 to22Health and Human Services and the White House23Coronavirus Task Force to determine how much the24hospital would receive directly.]25***Sargent's Court Reporting Service, Inc.(814) 536-8908She
111Approval of minutes of the June 23, 2020 meeting2CHAIRMAN LOISELLE:3May I have a motion to approve the June4minutes?5DR. WOODLAND:67Motion to approve.CHAIRMAN LOISELLE:891011Dr. Woodland moves.Do I have a second?MR. JOHNSON:Second.CHAIRMAN LOISELLE:12Commissioner Johnson seconds.13favor of approval of the June minutes,14signify by saying aye.15All inAny opposed?[The motion carried unanimously.]16***17[Rachel Levine, M.D., Physician General/Secretary of18Health, exited the meeting at 11:03 a.m.]19***20Introduction of Audience21[Keith E. Loiselle, Chairman, Public Member, requested22audience members introduce themselves.]23***24Introduction of New Board Members25[Keith E. Loiselle, Chairman, Public Member, requestedSargent's Court Reporting Service, Inc.(814) 536-8908
1212new Board members introduce themselves.Dr. Dillon, Dr. Yealy, and Mr. Eisenhauer3provided a brief summary of their professional4background.5Chairman Loiselle commented that the Board had6taken a couple of steps up based on the credentials of7everyone who is now on the Board and believed the8Board represented an even stronger force for9Pennsylvania citizens and licensees and would be an1011asset to the executive and legislative branches.Chairman Loiselle noted that Mr. John Mitchell’s12term on the Board had expired and he had been replaced13by Mr. Eisenhauer as the allied health professional14representative.15Chairman Loiselle thanked Mr. Mitchell for four16plus years of service, stating that he had a great17deal of respect for him and his opinions.18Chairman Loiselle noted also looking forward to19Mr. Eisenhauer’s opinions and activities on the20Board.]21***22Report of Prosecution Division23[Jason T. Anderson, Esquire, Board Prosecutor, stated24he had nothing to report today but was waiting for25decisions regarding consent agreements on the agenda.Sargent's Court Reporting Service, Inc.(814) 536-8908
131Chairman Loiselle referred to items 2 through 72on the agenda, noting Dr. Valigorsky recused himself3on item 5.4division members regarding cases 2 through 7.]5He noted no questions for prosecution***6Report of Board/Regulatory Counsel7[Shana M. Walter, Esquire, Board Counsel, referred to8the preamble and draft annex 16A-4941 written pursuant9to the Child Protective Services Law that had been10amended by Act 31 of 2014.11application for licensure under the Medical Practice12Act is required to complete 3 hours of continuing13medical education (CME) in child abuse and 2 hours for14renewals.15She noted that initialMs. Walter stated it also updates some16definitions in the Medical Practice Act to those17definitions found in the Child Protective Services18Law.19the Board are mandatory reporters and provides for20course approval by the Board in conjunction with the21Department of Human Services for those child abuse CME22classes.232425She noted it requires that all licensees underDr. Dillon questioned why midwives and physicianassistants do not appear under the requirement.Chair Loiselle recommended an expansion toSargent's Court Reporting Service, Inc.(814) 536-8908
141include nurse midwives and physician assistants to2page 25.3Dr. Yealy commented that the 3 hours and 2 hours4are straight forward but was not aware of evidence of5why it would be necessary every reapplication period.6Ms. Walter explained that the hourly requirements7that are written into the annex were made pursuant to8the Child Protective Services Law.9Cynthia K. Montgomery, Esquire, Deputy Chief10Counsel, explained the reason why there was not a11specific section having to complete the 3 hours.12noted § 18.141 lists the criteria for licensure of the13physician assistant, and one of those criteria was to14satisfy the requirements in § 16.12 relating to15general qualifications.She16Ms. Montgomery noted that the 3 hours are in17§ 16.12 but would amend § 18.141 to say satisfies the18licensure requirements in § 16.12, including the 319hours in mandatory training in child abuse recognition20and reporting.21Chairman Loiselle mentioned that there are times22where one document references another document but23both documents are not available to the Board at the24same time for review.25include the specific intent in both the documents andHe noted it to be better toSargent's Court Reporting Service, Inc.(814) 536-8908
151recommended the addition of nurse-midwives and2physician assistants.34Ms. Montgomery noted the addition to § 18.2 formidwives and § 18.141 for physician assistants.5Chairman Loiselle addressed Dr. Yealy’s comment6concerning the 2 hours of CE, where being able to7comment early on the rationale behind the 2-hour8requirement may have been helpful.9Chairman Loiselle commented that Steve Latanishen10and Commissioner Johnson have been very supportive of11efforts to allow the Board to have some input before12things get too far for the Board to do anything about13it.14Susan DeSantis, PA-C, Pennsylvania Society of15Physician Assistants, questioned whether anyone16reviewed the inquiry she sent last week concerning17regulation changes federally for the Department of18Education.19Ms. Walter acknowledged receiving the email but20noted the need for further review and discussion at21the September meeting.22Ms. DeSantis explained the issue concerning23education programs needing to verify they were meeting24the education requirements for licensure in all 5025states.She discussed child abuse and opioid creditSargent's Court Reporting Service, Inc.(814) 536-8908
161requirements for initial licensure.2bigger concern with physician assistant (PA)3educators, where this apparently applies to all types4of education for all licensees within the bureau that5would be getting this requirement for initial6licensure.7require CME but almost exclusively only during renewal8cycles, not initially.9She mentioned aShe noted PA programs across the countryMs. Wucinski mentioned working with Ms. Walter on10several regulations that had been set aside for11various reasons.1210 and questioned whether the Board wanted to move13those forward.14She referred to agenda items 9 andMs. Wucinski referred to draft annex 16A-494415regarding creating professional liability insurance16requirements for acupuncturist with the addition of17§ 18.15(4), where acupuncturists may provide services18to a client who does not present any symptoms of a19condition without diagnosis or referral from a20physician, dentist, or podiatrist.21Chairman Loiselle noted being in favor of both22items moving forward because they are clearly within23the purview of the Board and have implications for24citizens of Pennsylvania from a health and medical25liability perspective.Sargent's Court Reporting Service, Inc.(814) 536-8908
171Ms. Wucinski informed the Board she will pull the2memo concerning midwives to see why it was set aside3and include it on an upcoming agenda.4Dr. Woodland offered his assistance.5Chairman Loiselle acknowledged issues left6incomplete and requiring a lot of work but also the7importance of closure.89Angie Armbrust, Senior Associate, McNees-WinterGroup LLC, representing the Pennsylvania Affiliate of10the American College of Nurse-Midwives (PA-ACNM),11offered their assistance as well.12Chairman Loiselle mentioned doing a lot of work13ad hoc as opposed to having specific committees.14offered to form a committee and invite Ms. Armbrust15and Ms. DeSantis to join in those conversations.16HeChair Loiselle was hopeful to be able to form17committees over the next few weeks prior to the18September 2 meeting and was requesting everyone be19involved in at least one committee of their choosing.]20***21Report of Commissioner22[K. Kalonji Johnson, Commissioner, Bureau of23Professional and Occupational Affairs, thanked Board24members for continuing to be flexible and patient25through the virtual platform.Sargent's Court Reporting Service, Inc.(814) 536-8908
181Commissioner Johnson welcomed new Board members.2He noted the Board to be a high-caliber Board with a3wonderful group of professional and public members.4Commissioner Johnson thanked the members of the5public and stakeholders for participating in today’s6meeting.7director and policy fellow who have been very8instrumental in helping with issues.9He noted the hard work of the policy deputyChairman Johnson thanked Board counsel for their10help with regulatory waivers that allow practitioners11to continue practicing to meet the demands of COVID-1219.13Commissioner Johnson also noted the hard work of14Ms. Zerbe and program staff processing applications15and working under incredible circumstances to meet16demands.17their hard work throughout the pandemic.He also thanked prosecutorial counsel for18Commissioner Johnson referred to an executive19order outlining the principles that can be applied in20the virtual platform to administrative proceedings.21He reporte
Jul 28, 2020 · 1 State Board of Medicine 2 July 28, 2020 3 *** 4 [Pursuant to Section 708(a)(5) of the Sunshine Act, 5 the Board entered into Executive Session with Dana M. 6 Wucinski, Esquire, Board Counsel, and Shana M. Walter, 7 Esquire, Board Counsel, prior to the public meeting 8 for the purpose of conducting quasi-judicial
