The Commonwealth of Massachusetts

Executive Office of Health and Human Services Department of Public Health 250 Washington Street, Boston, MA 02108-4619
DEVAL L. PATRICK
GOVERNOR LIEUTENANT GOVERNOR

TIMOTHY P. MURRAY JUDYANN BIGBY, MD

SECRETARY

JOHN AUERBACH
COMMISSIONER

MEMORANDUM TO: FROM: DATE: RE: Commissioner Auerbach and Members of the Public Health Council Lauren Smith, MD, MPH, Medical Director Carlene Pavlos, Director, Division of Violence and Injury Prevention June 8, 2011

Request for Approval for Final Promulgation of Regulations 105 CMR 201.000: Head Injuries and Concussions in Extracurricular Athletics _____________________________________________________________________________ Introduction The purpose of this memorandum is to (a) inform the Council of public comments received on the proposed 105 CMR 201.000: Head Injuries and Concussions in Extracurricular Athletic Activities and the Departments response; and (b) request the Public Health Councils vote of approval for promulgation of the attached regulations (Attachment #1) as final regulations of the Department. The new regulation, mandated by Chapter 166 of the Acts of 2010, An Act Relative to Safety Regulations for School Athletes (Attachment #2), will require all public middle and high schools and those non-public schools that are members of the Massachusetts Interscholastic Athletic Association (MIAA) to have policies and procedures governing the prevention and management of sport-related head injuries. The regulations also include provisions regarding (1) statutorily required annual training; (2) statutorily required documentation of an athletes history of head injuries that have occurred prior to the start of each sport season; (3) required documentation of those that occur during the season; (4) requirements for medical clearance in those instances where

a student athlete has been removed from play for a head injury or suspected concussion; and (5) record retention and annual reporting of incidence and prevalence statistics to the Department of Public Health. This new regulation is a major component of the Departments overall wellness and injury prevention effort to keep adolescents engaged in extracurricular athletics safe and to prevent traumatic brain injuries.

Public Comment Process The proposed regulations were initially presented to the Council on January 24, 2011. Public hearings were held in Northampton on March 10 and in Boston on March 15, 2011. Seven (7) persons presented oral testimony at the Northampton hearing, which was attended by approximately twelve (12) people. Fifteen (15) persons testified at the Boston hearing, attended by approximately thirty-two (32) people. The period for written testimony was extended at the request of the Massachusetts Interscholastic Athletic Association and closed on Friday, April 8, 2011. Written comments were received from approximately 175 individuals and organizations; most written comments are posted on the Departments website. DPH conducted a thorough analysis of the issues and concerns raised by the public. Testimony and written comments were reviewed by staff in the Bureau of Community Health and Preventions Division of Violence and Injury Prevention, Essential School Health Program, and School-based Health Center Program in collaboration with the Medical Director and Office of the General Counsel.

Range of Comments Received The Department received comments from all over the Commonwealth (e.g. Mashpee, Sandwich, Boston, Somerville, Lincoln-Sudbury, Lowell, Gardner, Clinton, Westborough, Worcester, Northampton, Springfield, Greenfield, Sheffield and many others). We heard from different types of schools: large and small public schools; urban, suburban and rural schools; regional high schools; agricultural schools; independent schools that are MIAA members and an independent school that is not a MIAA member. We heard from individuals directly regulated by the proposed 2

regulations including parents; coaches; game officials; school superintendents; school principals; school athletic directors; school nurses and school physicians; certified athletic trainers; and neuropsychologists. We also heard from a range of health providers who care for concussed students including sports medicine and other specialists, injury prevention coordinators, and rehabilitation services coordinators at different hospitals. We heard from numerous professional organizations whose members work with youth who incur sports-related head injuries and whose membership are affected by these regulations including the: Academy of Clinical Neuropsychology Athletic Trainers of Massachusetts, Inc. Board of Registration of Allied Health Professionals Massachusetts Association of School Committees Massachusetts Chapter, American Academy of Pediatrics Massachusetts Coalition of Nurse Practitioners Massachusetts Interscholastic Athletic Association Massachusetts Medical Society Massachusetts Psychological Association Massachusetts Neuropsychologist Society Massachusetts School Nurse Organization Massachusetts School Superintendents Association Massachusetts Secondary Schools Athletic Directors Association Massachusetts State Basketball Officials Association National Academy of Neuropsychology Sports Concussion Clinic Primary Care Sports Medicine Childrens Hospital Sports Concussion New England

We heard from other organizations of health professionals who are not the subject of these regulations including American Physical Therapy Association of Massachusetts, Massachusetts Association of Physician Assistants, and Massachusetts College of Emergency Physicians. (Lists of individuals and entities providing testimony are attached as Attachments #3 and #4.) The one stakeholder group we did not hear from was students, although hearings were intentionally scheduled to take place after instructional hours to allow for their participation.

Summary of Comments and DPH Response

Members of the public were generally supportive of the proposed regulations. In fact, many suggested that the scope of the regulations be expanded to include town sports, such as Little League baseball or Pop Warner football. Many different stakeholders offered experience-based suggestions for how the regulations could be strengthened. Given the volume of comments, this Memorandum will summarize the comments and revisions by category.

A. Scope: Various stakeholders urged DPH to regulate more broadly, as outlined in Table 1. Table 1 Suggested scope All schools Pre-K through 12th grade Elementary schools All private or parochial schools Commentator Certified Athletic Trainer Berkshire School MIAA Executive Director; Lincoln Sudbury School Superintendent; Athletic Director HS Athletics Braintree Dr. Alan Ashare, MD Athletic Trainers of Massachusetts; BU Athletic Training Services/Education Program; Athletic Director Braintree HS; Director Athletic Training Education Program Springfield College Director of Athletics Westford Academy Tahanto Regional Middle/High School Boylston Coordinator for Health Services Quincy Public Schools; Norfolk County Agricultural High Director School Health Services Needham Public Schools Certified Athletic Trainer at Notre Dame Academy Norfolk County Agricultural High MIAA Executive Director Oakmont Regional High Lincoln Sudbury School Superintendent; Director Hydrocephalus Foundation Inc.; Director of Athletics Westford Academy; Coordinator for Health Services Quincy Public

Private schools that have no involvement with MIAA sports All athletes throughout the Commonwealth All students, not just those involved in extracurricular athletic activities All students who have experienced a head injury (elementary school, non-athlete) Head injuries occurring throughout the course of a normal school day (not just in extracurricular athletics) All activities, not just interscholastic athletic activities Non-school sponsored sports Intramural sports Club sports, other forms of organized sports & recreation

Collegiate athletics & adult leagues DPH Response on Scope

Schools Oakmont Regional High

At this time, the Department is not expanding the proposed scope of this new regulation. M.G.L. c.111 222(a) requires that: The department shall direct the division of violence and injury prevention to develop an interscholastic athletic head injury safety training program in which all public schools and any school subject to the Massachusetts Interscholastic Athletic Association rules shall participate including providing students that participate in any extracurricular athletic activity, including membership in a marching band[with] a summary of department rules and regulations relative to safety regulations for students participation in extracurricular athletic activities (emphasis added). Section 222(h) requires that The division shall adopt regulations to carry out this section. DPH interprets our mandate to scope this initial set of regulations accordingly and to focus on all public schools whose students engage in interscholastic athletics (typically at middle and high schools, not elementary schools) plus the subset of non-public high schools that are members of MIAA, recognizing that not all private and parochial schools are MIAA members. Further, the mandate is to focus on those students participating in extracurricular athletic activities. Nothing prohibits a school district or school subject to the regulation from adopting a policy that goes beyond the scope of the legislative or regulatory mandates, for example to cover K-12, intramurals, or all head injuries that occur in school, or for schools not subject to the regulation to adopt similar or broader injury prevention and intervention measures. Furthermore, organizers of town or club sports may chose to adopt these or similar prevention and intervention approaches. While DPH is not altering the scope of the regulations, the reporting forms required by the Act (requiring students and parents to submit updated reports of head injury and concussion history every season) and the requirement for reports of head injuries that occur during the sports season but not while participating in an extracurricular athletic activity (see Sections 201.008 & 201.009) do address some of the concerns of the Superintendent/Principal, Athletic Director, Athletic Trainer and Nurse at Lincoln-Sudbury High and other commentators who noted that the law covers interscholastic athletics but that students suffer concussions outside of interscholastic athletics. B. Perspective of Parents and Related Issues About Parents: 5

We were fortunate to hear from an extremely articulate parent with extensive experience navigating both the medical system and Massachusetts public school system with regard to the recognition, diagnosis, care and support of a teen with repetitive concussions. She articulated issues that echo concerns of many parents who spoke to us informally: While the athletic department may be the source of initial reporting, and the school nurse provides medical guidance, it is the academics that are spending the majority of time with the injured student. Guidance counselors and teachers should be well educated regarding the cognitive challenges these students face as well as their obligation to adhere to physician recommended academic accommodation plans and or 504 plans. Teachers should also play a central role in providing feedback to medical staff and parents regarding any changes they note in a students performance or affect. Further, in many schools, the guidance counselor serves as a point person for many student issues and should be designated as an active member of this team. The reality is that once the student is no longer participating in the sport, they are still faced with many other concussion related issues and the athletic department is only engaged at the level of monitoring stop from play or return to play; outside of the team, the student is adrift. Parents were supportive of schools sharing head injury information with teachers and guidance counselors etc. to tailor accommodation plans and monitor recuperating students, but parents and others raised issues about confidentiality and questions about HIPPA and the Family Educational Rights and Privacy Act. Several commentators suggested that we not overlook foster parents, an issue Mr. Jose Rivera flagged in January 2011 when we briefed the Council. Others, including the MIAA, suggested that the regulations expressly address non-English speakers, and Waltham Public School Parent Information Center suggested that multi-lingual materials be available by July for the fall sports season. School administrators asked whether a student would be allowed to participate if the student completed annual training but the parent did not. DPH Response Regarding Parents 1. Expanded the definition of parent to include foster parents. See Section 201.005. 2. Revised section on school policies, see Section 201.006.

a. Adopted the suggestion to require school districts and schools to include a teacher and a guidance counselor on the team that develops and reviews school policies and protocols regarding students who incur sport-related head injuries and concussions in extracurricular athletic activities. b. Added requirements that school policies must include procedures for providing information and forms and materials to parents; procedures for communicating with parents with limited English proficiency; and procedures for outreach to parents who do not return completed forms or verify completion of training. See M.G.L. c.111 222(a) (requiring parents to complete annual training) and M.G.L. c.111 222(b) (requiring the signature of both the student and the parent on the pre-participation form with updated information about head injury history at the start of each sports season.) c. Added requirements that school policies must include procedures for sharing information on a need to know basis consistent with applicable federal and state law. d. DPH defers to school policy makers and our sister agency the Department of Elementary and Secondary Education regarding parents suggestion that school policies may need a clearer definition of academic accommodations and a policy for addressing testing and grading of brain injured students. 3. Revised the training section to address teachers and guidance counselors, taking a balanced approach. The legislature mandated a categorical list of persons required to complete training on an annual basis but did not extend this mandate to teachers or guidance counselors. The suggestion from parents was for DPH to use its regulatory authority to require annual training for teachers and guidance counselors. While we agree that training for teachers, guidance counselors and other school personnel would be a good idea, the Department received comments from school and school district personnel about the burdens of annual training and is cognizant of the many demands on teachers and competing priorities for professional development. Consequently, the Department added the following modest requirement to the training section of the regulation, in Section 201.007(D): If a school district or school offers head injury safety training to guidance counselors, physical education teachers, classroom teachers or other school personnel, the school district or school at minimum shall offer one of the 7

current head injury safety training programs approved by the Department as specified on the Departments website. 4. Revised section on exclusion from play to strengthen reentry planning. a.While DPH did not adopt the parental suggestion that the plan for reentry for return to academic and extracurricular activities should be developed by a physician with expertise in concussion diagnosis and management and then executed in cooperation with the family and school staff, the regulation requires that the school-based team develop the plan in consultation with the students primary care provider or the physician who made the diagnosis and who is managing the students recovery; and, at the suggestion of Massachusetts Medical Society, the Department strengthened Section 201.010(E)(2) to require that the written reentry plan include instructions to parents, students, teachers, and coaches addressing physical and cognitive rest, graduated return to classroom studies etc. b.We agree that teachers observations would be invaluable in monitoring long-term effects and rate of recovery. Consequently, the Department also added a new requirement, Section 201.010(E)(2)(e), that all reentry plans include: a plan for communication and coordination between and among school personnel and between the school, the parent, and the students primary care provider or the physician who made the diagnosis or who is managing the students recovery.

C. Perspective of and about Schools A substantial number of comments were received from schools that indicated concern about administrative burden, suggesting that schools be allowed greater flexibility. Various school officials expressed concern that the Act itself and proposed regulations impose burdensome administrative requirements without providing funding or additional staff. (See, for example, comments of Superintendent of Somerville Public Schools, Director of Athletics for Westford Academy, and representatives of Athol High School and Clinton Public Schools, etc.) Of particular concern to MIAA, the Superintendent of Somerville Public Schools, athletic directors, and other

school administrators were clerical paperwork requirements imposed by the earlier draft of the regulation which literally required distribution of copies of forms to various personnel. Parents and others expressed concerns about compliance, and called for an entity outside of the school district to monitor compliance and/or conduct spot checks of school districts and schools. Athletic Trainers of Massachusetts, Inc. urged DPH to require all school districts and schools to submit their policies and procedures to DPH. Some suggested penalties for non-compliance.

DPH Response to Concerns of and about Schools 1. Substantially revised section on school policies expanding from 11 to 17 subparagraphs to list additional areas to be addressed through school policies and procedures with language specifically intended to give schools more flexibility in how they implement the required components of the regulations. See Section 201.006. 2. Added options in many sections for school districts and schools to develop and use their own school-based equivalent forms, which may seek more information than DPH model forms, in lieu of DPH forms so that schools do not need students and parents to sign two forms seeking the same information. See Sections 201.005 for new definition for school-based equivalent forms and Sections 201.006(A)(4), (6) and (11); 201.008(A)(2) (b), 201.008(B); 201.009(A); 201.011; 201.012(C)(3), (4), and (5); 201.013 (A)(2) and (3); 201.014 (C); 201.015(C), (D), (E); 201.016(A)(2), (3) and (4); 201.017(A). 3. Added options for school districts and schools to develop their own procedures for collection and distribution of forms or information from forms so as to ensure timely review by school nurses, school physicians, team physicians and certified athletic trainers, etc. and avoid unnecessary photocopying expenses. See Sections 201.006(A)(4)-(7), (11) and (15) as well as Sections 201.008(A)(2) and (B) and 201.009(A). 4. Revised, to provide more flexibility to schools in the digital age, the requirement to summarize the school policy on sports-related head injury in student and parent handbooks if schools choose to direct parents and students to a school or district website for the complete policy. See Section 201.006(A)(12).

5. Revised physical examination pre-requisite to align with existing DPH regulations requiring physical examinations on an annual basis, and in response to comments of several school nurses who noted that their schools, as a matter of school policy, accept physical examinations completed within 13 months for insurance coverage reasons, and such practice is consistent with MIAA rules for MIAA-member schools. Added a new sentence that school policies include information that students participating in multiple sports seasons only need one physical exam each year (the regulations continue to require such students to submit updated histories of head injuries and concussions at the beginning of each sports season). See Section 201.006(A)(3). 6. Added more flexibility for school districts and schools to develop their own protocols for return to play that may go beyond what the law and regulations require in response to comments from neuropsychologists and others that some school districts and schools may have protocols for return to play that go beyond what Section 201.011 requires. See new Section 201.006(A)(9). For example, according to the Athletic Director for Quabbin Regional High School, some schools have existing protocols in place that require all athletes to undergo baseline IMPACT testing at the beginning of the sports season and use subsequent testing results before authorizing return to play. 7. Provided school districts and schools time to develop policies and procedures in response to this regulation. See new Section 201.006(C) which gives school districts and schools until January 1, 2012 to submit an affirmation to DPH that they have developed policies in accord with the regulations. This affirmation requirement is new and was added in response to comments regarding the need to monitor compliance, including the specific suggestion of the Athletic Trainers of Massachusetts, Inc. that urged DPH to require all school districts and schools to submit their policies and procedures to DPH. The Division of Violence and Injury Prevention appreciates that different districts already have volunteered to share their policies with DPH as we develop best practice models, but we believe that affirmations and DESE/DPH options for on-site inspection of policies offer a sufficient regulatory mechanism to ensure school accountability. D. Perspective of Athletic Directors and about Athletic Directors

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The President of MIAA and many Athletic Directors commented about the existing burdens on school Athletic Directors who have responsibility for numerous sports and teams (e.g. for 31 variety sports and 56 teams in Concord-Carlisle High School). Some Athletic Directors (e.g. Clinton, Belmont) questioned why the proposed regulations made Athletic Directors, rather than the Superintendent or school leader, responsible for implementation and recordkeeping, citing M.G.L. c.111 222(e) that specifies that [t]he superintendent of the school district or the director of a school shall maintain complete and accurate records of the districts or schools compliance with the requirements of this section. Yet Massachusetts School Nurse Organization voiced its opinion that Athletic Directors must have primary responsibility, especially for collection and dissemination of information received before the start of the school year and Springfield Public School Nursing commented [o]nce the athletic department has assured that the physical exam and pre head injury information is complete, it will then be the responsibility of the school nurse to review. What is important and necessary is that schools strengthen the collaboration between these two departments for the safety of our students. The Athletic Trainers of Massachusetts, Inc. urged DPH to require the Athletic Director to ensure that pre-participation forms are completed 30 days before the start of each sport season. The Principal of Hampshire Regional pointed out that [a]s a small school, our staff does not include a full time athletic director ... [making] the requirement that the Athletic Director as the person responsible for implementation of the policies and protocols ... an unrealistic expectation. The Superintendent/Principal of Lincoln-Sudbury commented that requiring the superintendent or athletic director to collect proof of concussion education from all officials, referees, volunteers and miscellaneous agents of the school is unreasonable and virtually impossible. DPH Response Regarding the Athletic Director Staff attempted to balance differing opinions concerning where the responsibility for certain regulatory requirements would rest. In many instances, where the regulations assign a function to the Athletic Director, the regulations also provide flexibility to schools to designate a different school official for their school or district to accomplish the required function. Specifically: 1. Revised the section on school policies to permit a school district or school to designate an administrator other than an Athletic Director as the person responsible for implementation of the school or school district policy, see Section 201.006A(1).

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2. Clarified that Athletic Directors, unless school policies and procedures provide otherwise, are responsible for ensuring that students have met pre-requisites for participation. See Section 201.012(C). The default remains the Athletic Director, unless school district or school policy specifies someone else. 3. As to documentation and record maintenance, a. Revisions to the section on school policies, Section 201.006(A)(4)-(10) and 15, and the new stand alone section on documentation at Section 201.009, give different school districts and schools flexibility to set their own policies and procedures so long as the school ensures timely review and distribution of accurate, updated information about each athlete to various school personnel, allowing schools, for instance, to instruct students who have been removed from play for a head injury or suspected concussion to provide the school nursing department with medical authorization/clearance for his/her return to full activity, even though the legislature specified in M.G.L. c.111 s.222(c) that the student provide written authorization to the schools athletic director. b. Revisions to the section on participation requirements regarding ongoing requirements for parents to complete the Report of Head Injury Form, or schoolbased equivalent, give school districts and schools flexibility to set policies and procedures whether the form should be submitted to the athletic department or nursing department or another designee. See Section 201.008(B). 4. Clarified that Athletic Directors are not responsible for collecting written verification from game officials as to their completion of training requirements, making it an option for schools or school districts to request independent verification of game officials. See Sections 201.007(E) and 201.012(C). To the extent the regulations make the Athletic Director or another administrator of the school responsible for maintaining records that volunteers have completed requisite annual training, staff believe that the regulations (a) sufficiently define the subset of volunteers for whom records must be kept to mean those who volunteer in an authoritative role to assist students who are engaged in extracurricular athletic activities, and (b) sufficiently define such activities as an organized school sponsored athletic activities.

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E. Perspective of and about School Nurses School nurses generally supported how the regulations delineated their responsibilities and incorporated their professional expertise in reviewing and maintaining new head injury history forms and reports of head injury forms with other health records, participating in reentry planning, and monitoring recuperating students. As mentioned above, school nurses weighed in as to the need for coordination between the nursing department and athletic department. For example, several mentioned that nurses generally do not work during the summer, pointing to the need for Athletic Directors and coaches to be responsible for ensuring that those athletes who start practicing in August have met the pre-requisites for participation (student and parent completion of training, annual physical examination, documentation of the athletes history of head injuries). Some nurses voiced the opinion that a licensed physician trained in concussion assessment and management be the sole healthcare professional sanctioned by the Commonwealth to provide medical authorization for returning a student to play. A few offered technical suggestions as to the definition of school nurse. DPH Response Regarding School Nurses 1. Revised the definition of school nurse to be consistent with Board of Registration licensure standards. 2. Added new definition for nurse practitioner informed by the Board of Registration in Nursing Regulation Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.26(2). 3. Revised the responsibilities of the school nurse to enlist school physicians as needed and to avoid duplicative review of pre-participation forms if not needed. See Section 201.015(C). 4. Revised the section on school policies to include procedures for sharing information on a need to know basis, consistent with Family Educational Rights and Privacy Act. See Section 201.006(A)(15). 5. Revised section regarding medical clearance with extensive input from medical associations and professional licensure boards. See Section 201.011. See below for further discussion of the role of certified athletic trainers, neuropsychologists and nurse practitioners in clearing athletes to return to play. 13

F. Perspective of and about Certified Athletic Trainers We were fortunate to receive comments and helpful suggestions from the Athletic Trainers of Massachusetts, Inc. (ATOM) which formed a committee of athletic trainers and physicians with expertise in head injuries and who have worked closely with schools and school age athletes to solicit comments from approximately 1250 licensed athletic trainers including 300 working in middle and high schools. ATOM, the Board of Registration of Allied Health Professionals, BU Athletic Training Services, Springfield College Athletic Training Education Program, and others expressed concern that the regulations did not appropriately address the distinction between licensed athletic trainers and non-licensed trainers and urged DPH to define both certified athletic trainers and trainers. A school physician questioned the definition for certified athletic trainer and asked whether a licensed athletic trainer, who under these regulations can authorized return to play, can practice under the direction of a dentist. ATOM urged DPH to require trainers to complete one of the DPH-approved annual training programs, but not to require this of certified athletic trainers. ATOM and an MIAA Board member from Notre Dame Academy recommend that the statute be revised to require allied health professionals and medical professionals to complete DPH-approved training biannually or every three years, instead of annually, to coincide with continuing education requirements for renewal of their professional license. ATOM further recommended that DPH change the training requirement (which become effective in September 2013) for those health professionals providing medical clearance, to take into account that certified athletic trainers and others may have equal or more comprehensive training as part of licensure or continuing education requirements. Many certified athletic trainers urged DPH to require Athletic Directors to provide them with preparticipation forms 30 days in advance of the sports season. Some urged DPH to relax the statutory requirement for students who participate in multiple sports seasons to submit pre-participation

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forms at the start of the first activity of the academic year, rather than before the start of every season. DPH Response Regarding Certified Athletic Trainers 1. Revised the definition of certified athletic trainer, a statutory term used in M.G.L. c.111 222(c), to emphasize their licensure as allied health professionals and to align with other sections of these regulations. Although the definition of certified athletic trainer is derived from state licensure statutes that allow professional athletic trainers to practice under a physician or dentist, substantive sections of these regulations that address return to play specify that the certified athletic trainer may clear a student to play in consultation with a physician (defined in these regulations as a doctor of medicine or osteopathy). Consequently, for these regulations the definition no longer mentions dentists. 2. Added a new definition for trainers, a statutory term used in M.G. L. c.111 222(a) and (d), to distinguish individuals providing training support to athletes but who are not licensed allied health professionals and revised the section on annual training to ensure that such trainers who participate in school sponsored extracurricular athletic activities also need to complete annual training requirements. 3. Added a new stand alone section that delineates the responsibilities of certified athletic trainers. See Section 201.014. In the proposed regulations, their responsibilities appeared in a combined section with those of coaches. 4. Maintained the requirement that certified athletic trainers participate in annual training requirement in order to assure that they are aware of what parents, teachers, coaches and others are hearing in terms of symptoms of concussions, long term health impacts and exclusion from play and that they are reinforcing those messages. 5. Revised educational requirement for professionals who provide medical clearance to allow certified athletic trainers as well as others an equivalent way to satisfy this requirement through their re-licensure requirements. See Section 201.011(B). 6. Clarified that students participating in multiple seasons need submit only one annual physical but by statute must submit updated information about head injury history at the start of each season.

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G. Perspective of and about Coaches and Game Officials The Massachusetts State Basketball Officials Association and others requested the addition of a definition for game officials in Section 201.005. Additionally, a number of commentators questioned the proposed requirement for schools to document that game officials had fulfilled the annual educational requirement. Schools often encounter many game officials whose assignments vary, and assignments for a particular competition may be changed just prior to a competition. For schools to keep track of additional forms verifying whether a particular official was trained was seen as unduly burdensome, particularly when not required by the statute. Coaches, unlike game officials, are hired by school districts or schools. Several Athletic Directors explained that they hire numerous coaches over the course of every sports season for students to have the benefits of rich extracurricular offerings (e.g. Concord Carlisle High offers 31 varsity sports, 56 teams and has 70 coaches on staff; Northbridge Public Schools hires 52 coaches for 35 high school teams and 13 middle school teams). Their concern focused on the lack of support staff to help them manage new statutory and regulatory requirements for documentation of completion of annual training of the coaches who they hire. (See above for discussion of schools and Athletic Directors) Many comments addressed the need to assure communication between coaches and medical personnel particularly school nurses and certified athletic trainers in the event that an athlete is removed from play or a Report of Head Injury Form is received. The nurse leader for Scituate Public Schools stressed the fact that the legislation should be a catalyst for changing the sports culture that has deep roots in the mindset of coaches, athletic directors and those responsible for their schools athletic success. If nurses continue to be the responsible party for collection and dissemination of data surrounding concussions, it will further the business as usual and the lack of desired cultural change. Athletic departments need to embrace and own concussions for these regulations to have their desired impact.

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Yet we also heard from proactive coaches like the head football coach from Duxbury High who stepped forward to share how his district reduced the rate of concussions by teaching proper technique and having proper fitting equipment and urged a statewide protocol regarding protective equipment, such as mouth guards. And, we took notice of exemplary action after the enactment of the new law by a lacrosse coach who reportedly stopped the game rather than risk things getting further out of hand after an incident during a lacrosse game that resulted in the game being forfeited in favor of the visiting team.1 Nonetheless, concerns were raised by various interested parties that in competitions, a student athletes safety may be overlooked -- even by well trained coaches -- due to the pressure on coaches and their teams to win. Some health professionals and allied health professionals asked DPH to rank whose authority would be determinative if, for instance, a certified athletic trainer disagreed with a coach as to whether a head-injured athlete should be removed from play. A retired police officer proposed that coaches and others who violate the statutory and regulatory requirements in ways that endanger students should be dealt with by school districts and MIAA in a manner that is consistent with the seriousness of the violation, and urged the establishment of a complaint receiving mechanism. DPH Response Regarding Coaches and Game Officials 1.Added new definition for game official. The definition includes but is not limited to persons enrolled as game officials in MIAA. See Section 201.005. 2.Added more flexibility for schools and MIAA to work out mechanisms for verification that game officials have completed training. See Section 201.007(E). 3.Added a new stand alone section that delineates the responsibilities of coaches. See Section 201.013. In the proposed regulations, their responsibilities appeared in a combined section with those of certified athletic trainers and volunteers. 4.Although DPH was asked by certified athletic trainers and others to prioritize who makes the call to remove an athlete with a head injury or suspected concussion from play, DPH
1

See Steve Krause Three Swampscott lacrosse players suspended following fracas during game http://itemlive.com/articles/2011/05/14/news/news02.txt (last visited May 26, 2011)

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expects all regulated parties to play by the same rule articulated in any and all DPHapproved training programs: when in doubt, sit them out. Although regulations expressly assign responsibility to coaches and certified athletic trainers to remove athletes from play for head injuries, suspected concussions, and signs and symptoms of concussion, and even the briefest loss of consciousness, the Department intends that all adults who are on the field during practice or competition of extracurricular athletic activities will be educated with the same basic information about the signs, symptoms and risks of concussion and will work actively to protect student athletes from such head injuries and their consequences. 5.Revised the school policy section to include instructions to coaches, certified athletic trainers and trainers to promote protective equipment. See Section 201.006(16). 6.Revised the school policy section on penalties to include forfeiture of games, which in the world of competitive sports may be the most effective catalyst for putting student safety first. See Section 201.006(A)(17).

H. Perspective of Physicians and about Physicians We were fortunate to receive testimony from a number of physician professional associations as well as individual practitioners. Most comments were supportive of the regulations and offered additional collaboration regarding the training requirements for those providing medical clearance. Several commentators sought or offered clarification of clinical definitions. The Massachusetts College of Emergency Physicians (MACEP) asked for more explicit definition of head injury/concussion using lay language to allow for identification on sports sidelines. MACEP also expressed concern that the definition of head injury was overly broad for lay people, and could unnecessarily require children to be removed from sports and require medical clearance for a minor laceration or bruise to the scalp or face. With respect to Section 201.010, the substantive section regarding exclusion from play, Massachusetts Medical Society testified at the Boston hearing, offering the recommendations that

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physicians be more involved in the development of reentry plans and that specific instructions be provided to parents and teachers regarding graduated activities. With respect to the Section 201.011 on medical clearance and authorization to return to play, Massachusetts Medical Society and Massachusetts Chapter of the American Academy of Pediatrics strongly opposed any revision that would remove physician involvement in the medical clearance and return to play decisions by neuropsychologists. (For more on this topic see below Section I.) The Massachusetts Chapter of the American Academy of Pediatrics supported allowing nurse practitioners to make return to play decisions in consultation with a physician, and would support adding a physician assistant to the list. (For more on this topic see below Section J.) DPH Response Regarding Physicians 1. Revised the definition of head injury with assistance of MDPH Medical Director

in response to clinicians and President of MIAA. Clarified that head injury may ensue from either a direct blow to the head or indirect trauma. Added a second sentence to clarify that lacerations of the scalp or face are not in and of themselves the type of head injury that requires exclusion from play. 2. Added new definition for team physician. This term appeared in the proposed definition for the school physician; however the school physician from Northampton High School commented that team physicians are not always school physicians. Final regulations add a separate definition for team physician and revise the definition of school physician accordingly. 3. Declined to clarify definitions to allow for sideline diagnosis. The law and substantive sections of these regulations require removal from play for suspected concussions or signs and symptoms of concussion and are clear that there can be no return to the same game or practice. In fact, return to practice or competition is permitted only after written authorization and medical clearance. Therefore, the intent of the regulations is that diagnosing on the sidelines is not permissible.

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4.

Adopted Massachusetts Medical Societys suggestions for strengthening the section

on return to play. (See above DPH response to concerns of parents for revisions of Section 201.010.)

I. Perspective of and about Neuropsychologists No single issue in the regulations received more public comment than that of the role of neuropsychologists, particularly in providing medical clearance to return students to play. In fact, likely due to requests from their professional associations, comments were received from neuropsychologists across the country and the world. These comments centered on the neuropsychologists role in medical clearance. Neuropsychologists strongly objected to proposed text which specified that a neuropsychologist could authorize a student to return to play after the student has been examined and cleared by a licensed physician. The Departments proposed regulatory language2, with the modifier, represented the medical consensus of an expert clinical advisory group, convened by the DPH Medical Director. (The Council was given a list of all members in our January briefing.) The Massachusetts Neuropsychological Society subsequently testified that the modifier be deleted altogether. The Massachusetts Chapter of the American Academy of Pediatrics opposed altering the modifier and the Massachusetts Medical Society submitted additional written comments after the hearings strongly supporting the proposed regulation, expressing concern that if the modifier were dropped to give independent practice rights regarding medical clearance of injured students to neuropsychologists (who are licensed simply as psychologists as there is no specific licensure category for neuropsychologists in Massachusetts), DPH would in effect give such practice rights

The proposed regulation Section 201.011(A)(4): Medical Clearance and Authorization to Return to Play specified medical clearance by (1) a physician, (2) a certified athletic trainer in consultation with a licensed physician (3) a duly licensed nurse practitioner in consultation with a licensed physician and (4) a neuropsychologist after the student has been examined and cleared by a licensed physician. (emphasis added)

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to all psychologists, including those with no hospital affiliation, no significant and specific training and little or no access to comprehensive medical consultations. With respect to other sections of the regulations, Massachusetts Neuropsychological Society proposed that the neuropsychologist be available to provide consultation in the process of academic reentry, a role suggested in the definitions section of the regulations, but not later specified. The Children's Hospital group also recommended that neuropsychologists play a role in management of accommodations for graduated return to play.

DPH Response Regarding Neuropsychologists With respect to medical clearance and return to play, DPH considered the statutory text3 and the plethora of comments from neuropsychologists, both in and outside of Massachusetts, as well as opinions of Massachusetts Medical Society, Massachusetts Chapter of the American Academy of Pediatrics, parents (that the reentry plan be developed only by a physician) and some school nurses and others (that a licensed medical physician trained in concussion assessment and management should be the sole healthcare professional sanctioned by the state to provide medical authorization). Given the conflicting views, DPH Medical Director consulted directly with the Board of Registration of Psychologists, the president of the MA Neuropsychological Society, staff from Childrens Hospital Neuropsychology service, and other experts. Since Massachusetts does not have a licensure category for neuropsychologists, DPH worked with the Board and experts at Childrens Hospital to better define the subset of psychologists who the legislature likely had in mind. Since the decision to return an injured student to play is a medical decision which, in the opinion of the Massachusetts Chapter of the American Academy of Pediatrics and our clinical advisors, requires at the very least consultation with a physician, DPH decided to try to find language that would best describe the working relationship between these specialized psychologists and physicians in the context of returning injured students to extracurricular athletics and academics. It was understood that neuropsychologists, functioning in the role of a specialist,
3

The statute specified clearance by a physician, or a licensed neuropsychologist or a certified athletic trainer or other appropriately trained or licensed health care professional as determined by the DPH. M.G.L. c.111 222(c).

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would communicate with an injured athletes primary care provider or the physician managing other aspects of his or her recovery. DPH believed that this represents best practice and is consistent with the Departments efforts to promote a medical home for children. As a result, DPH made the following revisions: 1. Revised the definition of neuropsychologist in Section 201.005 to refer to licensure and certification as a health service provider by the Board of Registration of Psychologists with additional specialized training and expertise in applied science of brain-behavior relationships and specific experience in evaluating neurocognitive, behavioral and psychological conditions and their relationship to central nervous system functioning. 2. Revised the section on medical clearance and authorization to return to play, Section 201.011(A), to read: Only the following individuals may authorize a student to return to play: (1) A duly licensed physician; (2) A duly licensed certified athletic trainer in consultation with a licensed physician; A duly licensed nurse practitioner in consultation with a licensed

(3) physician; or (4) A duly licensed neuropsychologist in coordination with the physician managing the students recovery.

The inclusion of licensed physician in categories 2-4 reflects the Departments intent to ensure that the full range of possible medical causes of an athletes symptoms and the possible complications of his or her injury have been considered. It is the Departments intent to reflect the usual nature of practice of certified athletic trainers, nurse practitioners and neuropsychologists and to promote effective communication among all of an injured athletes health care providers. 3. Revised the section on school policies to require school districts and schools to include a neuropsychologist, if available, on the team that develops and reviews school policies and protocols regarding students who incur sport-related head injuries and concussions in extracurricular athletic activities. While DPH applauds those school districts that offer baseline neuropsychological testing and avail themselves of consultations with neuropsychologists in reentry accommodation planning, the Department recognizes that not

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all school districts and schools subject to these regulations have access to these services. See Section 201.006(A). 4. Adopted the suggestion of the Massachusetts Neuropsychological Society to include a neuropsychologist, if available, in the development of a reentry plan for a concussed student. See Section 201.010(E)(1). 5. Revised the section on exclusion from play, which as originally proposed included frequent assessments by the school nurse and periodic medical assessments of recuperating students, to specify that the reentry plan include the frequency of assessments by the school nurse, school physician, team physician, certified athletic trainer or neuropsychologist as appropriate until full return to classroom and extracurricular activities are authorized. See Section 201.010(E)(2)(e).

J. Perspective of and about Other Health Care Providers DPH received testimony from the Massachusetts Association of Physician Assistants, and its members, and the American Physical Therapy Association of Massachusetts, and its members, regarding Section 201.011(A), requesting that physician assistants and physical therapists be added to the list of practitioners who could authorize a student to return to play. Parents echoed the request for such permission for physician assistants, citing access issues. Meanwhile, the Massachusetts Coalition of Nurse Practitioners, while recognizing that no nurse practitioner works outside of a collaborative relationship with a physician, suggested that DPH recognize their professional status as primary care providers and drop the modifier in consultation with a physician which they fear school districts may misinterpret to mean that further documentation by a physician is necessary if a nurse practitioner clears a student to return to play and an academic plan. Yet DPH also received comments from the Medical Director of Family Health Center of Worcester School Health Services, who supervises nurse practitioners who are often called upon to clear students to return to play, urging DPH to develop a standard clearance protocol for return to play which would ensure uniform treatment and documentation of progress by nurse practitioners and primary care physicians.

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A retired Fire Chief who is a licensed Emergency Medical Technician (EMT) strongly supported the regulations and proposed that a representative of Emergency Medical Services be included in all aspects of the regulations, as many times EMTs are first responders on the scene of a head injury.

DPH Response Regarding Other Health Care Providers 1. Based upon consideration of the DPH Medical Director and the guidance of the expert clinical advisory group, DPH is not expanding the categories of professionals who are allowed to medically clear and authorize injured students to return to play, other than as in the originally proposed draft of the regulations. Should provider access prove to be a barrier for students seeking medical clearance to return to play, Section 201.011(A) of the regulations can be amended in the future. 2. DPH did go beyond the statutorily enumerated categories of professionals to add nurse practitioners to the list based on their advanced practice training and licensure, but we agree with the Massachusetts Chapter of the American Academy of Pediatrics and our clinical advisors and have retained the modifier. However, DPH does not intend this to imply that additional documentation from a physician is required when a nurse practitioner has cleared an athlete to return to play; because, as acknowledged by the Massachusetts Coalition of Nurse Practitioners, all nurse practitioners work in a collaborative relationship with a physician. 3. DPH agrees that many primary care providers could benefit from training and development of uniform protocols, and will be working with various medical associations on these initiatives.

K. Concerns About The Statute That Are Beyond DPHs Authority To Address

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Some of the concerns raised about the frequency of required trainings and the multiplicity of documentation would require legislative action to revise. Below are the sections of the law that received the most objections: (1) The statutory requirement in M.G.L. c.111222(a) that training be required of athletic directors, coaches, trainers, school physicians and nurses, marching band directors annually. (2) The statutory requirement in M.G.L. c.111 222(a) that students who participate in any extracurricular activity, including marching band, be provided with certain written information annually (not just the first time the student signs up). (3) The statutory requirement in M.G.L. c.111 222(b) for documentation of an athletes history of head injuries at the start of each sport season. (4) The statutory requirement in M.G.L. c.111 222(c) that the student provide written authorization/medical clearance to the schools athletic director.

CONCLUSION The proposed regulations, mandated by M.G.L. c.111 222, establish the regulatory framework needed to ensure that students who participate in various interscholastic extracurricular athletic activities across the Commonwealth and their parents are informed about the latest brain injury science; school districts and schools subject to these regulations have policies and procedures in place to protect the health and safety of young athletes who incur head injuries concussions or suspected concussions during extracurricular athletic activities; and all adults involved with these students have a uniform approach to identifying potential concussions, removing students from practice or play, responding to reduce the risk of future concussions or long term health impacts, and as understanding the need of recuperating students for graduated return to athletics and academics. We request approval for final promulgation of the attached regulations. Following PHC approval, the Department will file the regulations with the Secretary of the Commonwealth for publication in the Massachusetts Register.

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Attachments: Attachment 1: Proposed Final Regulation 105 CMR 201.000: Head Injuries and Concussions in Extracurricular Athletics Attachment 2: Chapter 166 of the Acts of 2010, An Act Relative to Safety Regulations for School Athletes Attachment 3: Listing of In-State Commentators Attachment 4: Listing of Out-of-State Commentators Attachment 5: Proposed Regulation 105 CMR 201.000 presented to PHC in January 2011 with Redlined Changes

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