The Massachusetts Chapter

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1 The Massachusetts Chapter Executive Director Cathleen Haggerty P.O. Box 9132 Waltham, MA Fax Immediate Past President Lynda Young, M.D., FAAP Worcester, MA President Karen R. McAlmon, M.D., FAAP Winchester, MA Vice President Carole Allen, M.D., FAAP Somerville, MA Treasurer Elizabeth Brown, M.D., FAAP Boston, MA Secretary Julie Meyers, M.D., FAAP Worcester, MA District Representatives District 1 John O Reilly, M.D., FAAP District 2 Philippa Sprinz, M.D., FAAP District 3 Lisa Capra, M.D., FAAP District 4 Joshua Gundersheimer, M.D., FAAP District 5 Shailesh Shah, M.D., FAAP District 6 Eric Sleeper, M.D., FAAP District 7 Robyn Riseberg, M.D., FAAP District 8 Pearl Riney, M.D., FAAP District 9 Paula McEvoy, M.D., FAAP District 10 OPEN Counsel Edward Brennan, Esq. Norwell, MA (781) Testimony of the Massachusetts Chapter of the American Academy of Pediatrics Before the Department of Public Health Regarding Proposed Amendments to Regulations of the Department of Public Health 105 CMR Licensure of Clinics - September 27, 2007 This testimony is submitted on behalf of the Massachusetts Chapter of the American Academy of Pediatrics (MCAAP) and its 1,700 pediatrician members regarding the proposed amendments to the Licensure of Clinics regulations which would allow licensure of limited services clinics. My name is Karen McAlmon, M.D., FAAP, and I am President of the MCAAP. My testimony submitted today expands upon my oral testimony presented at the September 5, 2007 hearing on the proposed regulations. The members of the MCAAP are physicians dedicated to improving the quality of life for children by providing quality health care and advocating for them and their families. The MCAAP is committed to the attainment of optimal physical, mental and social health for all infants, children, adolescents, and young adults. We want to ensure that children receive the highest quality and safest care possible; therefore, we want to express our concerns about the care of children at limited services retail based clinics. Though our concerns mirror many of those you have heard from our colleagues and we specifically endorse the comments of the Massachusetts Medical Society, we will focus on the ones specific to children and pediatricians. In particular I will focus on the medical home, pediatrician access and immunizations in addressing why we believe limited services retail based clinics are NOT appropriate for children. Overall Position MCAAP opposes limited services retail based clinics as an appropriate source of medical care for infants, children and adolescents because of concerns regarding disruption of the medical home; fragmentation of care; lack of access to and maintenance of a complete, accessible and central health record containing all pertinent patient information; the lack of proper follow up when diagnostic tests are utilized or prescribed treatment does not work; the potential missed opportunity to address other medical and behavioral health issues as well as to catch up on immunizations. Medical Home Pediatricians in Massachusetts are committed to maintaining the medical home. The medical home provides accessible, family-centered, comprehensive, continuous, coordinated, compassionate, and culturally effective care for which the pediatrician and the family share responsibility. To help achieve this high standard of care, we provide outstanding access in our practices. More so than other specialties, pediatricians work very hard to be available to our patients. Massachusetts pediatricians are available by phone 24 hours a day, 7 days a week, 365 days a year. Pediatricians schedule sick patients for same day office visits and stay in their offices until the last sick child with an appointment is seen. Utilizing coverage groups pediatricians provide in-office weekend sick hours every weekend day and holiday.

2 A recent survey 1 of our members reveals: 90% of responding pediatricians are in group practice with group size ranging from 2 to ~50 (on average 4 to 8) 78% of responding pediatricians are covered only by those in their group practice during their off hours and therefore there is potential for access to patient records The majority have office hours that extend into the evening and on weekends 95% of responding pediatricians have built in sick appointments in their daily schedule 75% of the time parents calling for sick visits for their children are seen within 8 hours and 100% within 24 hours The average waiting time to see the provider once the child arrives for an appointment is usually < 30 minutes 2/3 of responding pediatricians use nurse practitioners or physicians assistants in their offices With this commitment to coverage in the medical home, we believe there will not be the need for children s visits to retail based clinics. Pediatric Workforce and Access The pediatric work force in Massachusetts has not been declining. Based on statistics from the AAP Committee on Pediatric Workforce and residency training programs, we know that the number of pediatricians has been increasing nationally 2,3 and pediatric residency positions are 97% filled (compared with 96% for internal medicine and 88% for family practice) 4. Nationally, as well as in Massachusetts, the number of pediatric residency training programs and the number of positions has remained stable. In fact, there are many more applicants than positions and the programs are full. Nationally the average pediatrician to population ratio is 1:1,769 for children <18 years old. In Massachusetts that number is 1:1, Based on this data, we believe that access to pediatricians will remain consistent for the foreseeable future. Immunizations The Commonwealth Fund Commission on a High Performance Health System recently submitted its first state by state scorecard of the country s health system performance. Massachusetts ranked first in the nation in health care equity, second in access and third in quality 5. This is a record which we should be proud of. Our record on childhood immunizations has contributed to these rankings. In the recently published results of the National Immunization Survey for 2006, Massachusetts remains first in the nation in childhood immunization rates for the third year in a row 6. We believe that the state s record on immunizations is a testament to the Commonwealth s Universal Vaccine Distribution Policy, the Department s immunization initiative and the medical home model of care practiced by pediatricians, family practice physicians and neighborhood health centers. The proposition that limited services clinics would administer immunizations threatens this record because they would not have access to the documentation of the immunizations given in the medical home, and, by providing this component of a well child visit, they would undermine the need for patients to see their pediatrician for the other services provided during a well child visit, including Early Periodic Screening, Diagnosis and Treatment (EPSDT) services recommended by the AAP and required by Medicaid. Administration of selective vaccines at limited services retail based clinics, as has been proposed by CVS MinuteClinic, increases the risk of under immunization especially in light of the increasing complexity of the childhood immunization schedule. Any regulation regarding the scope of practice for these entities must deny the practice of immunizing children.

3 Specific Sections Sections: Definition of Limited Services, (f) Limited Services List, Policies and Procedures for Limited License Clinics Rather than have limited services clinics determine what services they offer, which may vary from clinic to clinic, we believe the Department, in conjunction with medical experts, should define which services are appropriate for limited services clinics to offer. The care offered should be limited to episodic, urgent care related to an illness. With regard to the pediatric population, we urge you to structure limited services retail based clinics such that children are excluded. We believe that the type of care proposed by some retail clinics is more appropriately provided in the patient s medical home where the patient s history and medical records are available to the practitioner. Children 24 months and under are at particular risk due to the many medical encounters required in the first 24 months of life (during the first year of life, infants have 6 routine pediatric visits; in the month age group, there are 4 routine pediatric visits), the need to firmly establish the medical home; the need to ensure completion of required immunizations; the increased risk for significant compromise with infectious diseases in this age group, and the need for developmental assessments. We understand that retail clinics have their own cut off age for treating young children and it varies from retailer to retailer. The MCAAP would urge the Department to impose an age cut off for children below which treatment at a limited services retail clinic would be prohibited. Moreover, for all children, screening services and immunizations which are part of a well child visit provided in the medical home, as well as physicals (including physicals for school or camp attendance), should not be provided by limited services retail based clinics. Section Off-Hour Coverage Retail based clinics do not provide any follow up medical care, either for illnesses they diagnose or for the complications that may arise from the treatment prescribed. In other states, we have learned that retail clinic staff is not available to answer any after-hours questions; the retail clinic care model has an assumption that some other medical professional will be responsible for providing needed follow-up care. The child s pediatrician on call, who never saw the patient in the first place, is by default responsible for these questions an allergic reaction to a medicine or no clinical response to a medication or further questions about the diagnosed medical condition. We believe that limited services clinics must have an answering service that is accountable for the patients it treats, and not simply have a taped message that directs patients to other providers as provided in Section If the retail clinic treated the patient, it should be responsible for monitoring and adjusting the care it provided. The standard for a health care practitioner providing care for their patients is to have an answering service that allows for the patient to make contact with the health care provider or group that provided the services. Indeed, contracts with third party payors reflect this standard and those contracts specifically require a provider to have an after hours answering mechanism with coverage that is responsive to calls from patients. The regulations should be amended to require that a limited services clinic practitioner respond to a patient s call regarding any treatment the patient received at the clinic. They examined the patient. They have the medical record of the visit. The clinic should be responsible for their care. Simply allowing a recorded message telling the patient to go to another provider is not appropriate care, particularly when the other provider does not have access to a record of the patient s encounter at the clinic. In addition, there must be a paper trail and a structure where they can give feedback to patients and physicians. Section Policies and Procedures for Limited Services Clinics (H) and (I) It is ironic that many years ago, pharmacies battled to prevent physicians from prescribing and dispensing medications, and yet, today, many are planning to provide medical care in their business. If a prescription is given, in all likelihood it will be filled at that pharmacy.

4 Unlike in a pediatrician s office, there may not be an incentive to prescribe the most cost effective drugs. The conflict of interest of a pharmacy providing the medical care and then the prescribed medications are obvious. If limited services retail based clinics are to exist, they should be required to have generic prescribing practices. Similarly, they should be discouraged from recommending over-the-counter medications of unproven efficacy or with a substantial potential for adverse events. Sections , 205, 206 and 207. Storage, Hand Washing, Toilet and Janitor s Closet. Regulations for limited service retail based clinics should ensure that the public is protected from infectious disease (contagious diseases can be more prevalent in children) by utilizing appropriate infection control measures to prevent the spread of contagious diseases; require appropriate hygiene facilities including bathrooms and hand washing facilities in the clinic; have appropriate examination facilities, waiting areas and receptionists to assist patients; and have appropriate handicapped access. We do not believe the Department should allow a clinic that sees sick patients to not have appropriate hygiene facilities including hand washing facilities and a bathroom in the clinic space. This runs counter to good medical practice and the Department of Public Health s efforts to reduce infections in health care facilities. We cannot imagine treating patients without appropriate measures to guard against the spread of contagious disease. Section Annual Statistical Report. Limited service clinics must follow all quality and reporting guidelines and standards required of other practitioners or clinics as defined by DPH and other certifying and monitoring bodies including DPH, Medicaid, and Medicare. SUMMARY In summary, the MCAAP believes that it is the responsibility of the Chapter and the DPH to safeguard quality of care for children. We are not willing to sacrifice quality for cost, and hope that the Massachusetts Department of Public Health will continue to enforce the well thought out current guidelines and standards it created for the protection of the public in general and for our children in particular. For profit organizations should not be granted unfair advantages compared with private practice physicians or neighborhood health clinics. Limited services retail based clinics are not an appropriate site for delivery of health care to children. We appreciate the diligence of the Department of Public Health in examining the request of the CVS MinuteClinic for licensure in Massachusetts and in responding to the concerns of the medical community that there be an open process for reviewing the potential benefits and risks of incorporating this form of health care into the Massachusetts health care delivery system. We hope that in the development of a regulatory process for limited services retail based clinics that the Department will use the same thorough process and standards as previously used to determine the regulations for other types of clinical services and create a level playing field for the delivery of quality care to children in Massachusetts. We commend you on your decision to delay licensure until new and appropriate regulations for clinics with a limited scope of practice are in place. We believe that these proposed regulations need additional refinement and urge you to take the time to address the issues raised here and in other testimony to fashion regulations that will continue to ensure the high quality of care that Massachusetts is known for. Moreover, any regulations developed by the Department relative to limited services clinics need to be revisited on a periodic basis to determine whether health care in the Commonwealth is improved or harmed by the creation of these limited services clinics.

5 Thank you for the opportunity to address these proposed regulations. Respectfully submitted Karen R. McAlmon, M.D., FAAP President References: 1 MCAAP Survey Monkey Survey August Pediatrician Workforce Current Status and Future Prospects. Pediatrics 116: 2005 e156 originally published online June 15, doi: /peds Ethan Alexander Jewett, Pediatrician Workforce Data, August 2005, 4 AAP Division of Graduate Medical Education and Pediatric Workforce Data Tables from the National Resident Matching Program 2007 Match 5 JC Cantor, C Shoen, D Belloff, SKH How and D McCarthy Aiming Higher Results from a State Scorecard on Health System Performance. The Commonwealth Fund Commission on a High Performance Health System, June

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