January 13, Lois M. Nora MD JD MBA President and CEO American board of Medical Specialties. Dear Dr. Nora,

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1 January 13, 2016 Lois M. Nora MD JD MBA President and CEO American board of Medical Specialties Dear Dr. Nora, CMSS is pleased to comment on the proposed ABMS Standards for Focused Expertise. We have uploaded our comments electronically, and are putting them together here as an added resource for ABMS. To summarize, although we have commented on each of the twelve elements, we consider certifying focused expertise to be unnecessary, with more negative unintended consequences than value. Moreover, this may not be a good time for ABMS to add to requirements for additional certification. Perhaps enhancing Maintenance of Certification should be the continued priority of ABMS at this time, as progress seems to be being made in that area. First things first. 1. The area of focused expertise contains a distinct and definable patient population, a definable type of care need, a stand alone body of medical knowledge, or unique care principles solely to meet the needs of that patient population. We can think of at least nine possible foci in one specialty. Where does it end? If there is not enough clinical reason to have a sub-specialty, do we need to validate that some may limit their practice to a certain area? To what end? Reimbursement? Eliminating others from providing these services? We worry about the long term impact on the specialty and that there is the potential of diminishing patient access to these services. The concept of a stand alone body of medical knowledge seems to forget that even the most focused knowledge is only understood within the context of a specialty field and the fundamentals of the field of medicine as whole. In another example, recognizing that areas of focused expertise shall not substantially adversely impact existing certificates is a thoughtful gesture but one that cannot be put to the test with any certainty based on the current document. The term stand alone may not be the best. A focused area of medical knowledge does not stand alone but is a defined segment of the broader body of knowledge in that area of medicine or surgery. Indeed, some fellowships are valuable because they increase the fellow s experience through additional volume, or through additional practice in a complicated technique (robotics).

2 We caution ABMS and the 24 member Boards to take additional if not extraordinary measures to ensure that there is no confusion in the medical or surgical communities or by the patient and public as to the distinction between a certificate and certification. 2. The area of focused expertise shall not duplicate and/or substantially adversely impact existing specialty or subspecialty certifications. We have concern regarding the Certificate of Focused Expertise. If ABMS adds this pathway creating semi-sub specialization, what is left for the specialty? There should be a preface to this document. What prompted its development? If it is about Certificates of Added Qualifications, (CAQ) then that vocabulary exists already and should be used, instead of creating new vocabulary. With regard to the concept of focused interests, there is a particular concern about diluting or devaluing the certification at the primary level. The typical surgeon in a given specialty does many different types of procedures and to have to obtain some form of subspecialization in each area of the specialty would be a considerable burden without any added value to the patient. On the large scale, as an organization representing many specialists, we share the concern other groups have raised regarding the absence of compelling reasons to formally recognize additional depths of specialization. Implementing an approach to recognize focused expertise further divides the house of medicine. We would also be concerned about the wherewithal of any ABMS board, ABIM included, to appropriately develop and implement a variety of appropriate MOC approaches were recognition of focus expertise to proliferate. We can appreciate that focusing does happen in practice, but this seems to be an overreach by ABMS to take on the mantle of owning specialty recognition, which is a matter best left to the field as represented by the medical societies. The definition of substantially adversely might be difficult to establish. Perhaps just delete the word substantially? Or can criterion #2 and criterion #3 be combined? 3. The new area of focused expertise should clearly demonstrate its value in improving access, quality, and coordination of care. This added value should justify any potential increase in cost of care. Focused certification can lead to confusion on the part of organizations that provide credentialing and privileging. Well-trained generalist physicians who are well qualified based upon training, experience, and current competence without a special certificate for focused expertise, may be inappropriately denied clinical privileges. The same situation may apply for well-qualified sub-specialists who lack a special certificate of focused expertise.

3 The potential deleterious impact on patients is even more concerning than the impact on physicians. The public is already challenged in their understanding of board certification. Additional certificates of focused expertise will likely only add to the confusion. Access to care may be further challenged because of the patient s confusion by creating uncertainty as to who is best qualified to deliver the care that the patient needs. Bottlenecks may be created in those communities that restrict privileges to only those holding the most-narrow certificates of focused expertise, when there may be well-qualified physicians who can safely and effectively deliver the needed care. How will this certificate be interpreted by Hospital Boards granting privileges? How will physicians seeking the focused expertise certification be able to demonstrate value in improving access, quality, and coordination of care? What is meant by the reference to justification of any potential increase in cost of care? How would cost increases associated with this new certification path originate? The new area of focused expertise should clearly demonstrate its value in improving access, quality, and coordination of care. This added value should justify any potential increase in cost of care. It is not clear how this additional burden of certification would improve access to care. This criterion seems to be in conflict with documentation for both initial certification and maintenance of certification because neither of these processes have demonstrated concrete value in improving access, quality and coordination in care. Therefore, we suggest either modifying or eliminating this criterion. Or can criterion #2 and criterion #3 be combined? 4. There should be a periodic reassessment of approved areas of focused expertise to assure that the area of clinical practice remains a distinct area of certification. What frequency will exist for periodic reassessment? Who will develop and administer the reassessments? First, remove the last word certification and replace with expertise. Second, continuous assessment of the current body of knowledge and practice in an area of medicine should be a hallmark of all assessment organizations. 5. Patient care and safety will be improved by implementation of the area of focused expertise. How would the added value of focused certification bring about improvements in patient care and safety in the area of focused expertise? How will this be determined? Does this imply that an oncologist with focused certification in breast cancer will provide better care

4 than an oncologist with medical oncology certification, whose practice s primary patient population is breast cancer? We caution ABMS and the 24 member Boards to take additional if not extraordinary measures to ensure that there is no confusion in the medical or surgical communities or by the patient and public as to the distinction between a certificate and certification. We suggest that a feasibility study be conducted by each Board with respect to any and all certificates of focused expertise before they are established. This feasibility study would include a critical examination of the focused area of practice and the effect it has or may have or does not have on patient care and safety. However, this criterion seems similar to criterion #3, can they be combined? 6. An eligible diplomate must be certified by an ABMS Member Board and have an active primary or relevant subspecialty certificate. We would raise the one consistent concern that we have with any change related to the Boards: what are the potential (unintended) consequences for those subspecialties with multiple co-sponsoring Boards? While one certifying board is responsible for administration of the exams for one sub-specialty, nine or more sponsoring boards set the policies for various specialty areas of certification. 7. Additional eligibility criteria will be defined by associated Member Board(s). While supportable, we caution the member Board not to establish criteria that might seem onerous or capricious in an effort to discourage or dissuade the creation of a certificate of focused expertise. 8. The educational program must be at least 12 months in duration. How much of a specialist s practice must be dedicated to the area of focused practice, in addition to their additional training (minimum of 12 months) to qualify? Is the proposed 12-month educational program in addition to training already completed and recognized in fellowship? Would this additional training add another year to existing fellowship programs? Instead of defining a required length for the training, would it be better to define a curriculum that should be completed? What is the benefit of defining that the training occur over a 12-month period? These proposed standards for focused expertise run contrary to the experience of ABIM in recognizing hospital medicine.

5 In principle, a certificate in focused expertise should have a prescribed curriculum, matriculation process, both self-and standardized assessment, but not necessarily based on a predetermined eligibility period to complete the program of study but rather successful achievement of competency. 9. Training should occur in either an ACGME recognized training program, a program accredited by a specialty society, or a program with standards recognized and defined by the relevant ABMS Member Board. In a number of specialties (particularly with little hospital focus and no institutional funding), some of the best fellowships are not ACGME-accredited and (failing the desire of the specialty society to become involved) might find themselves in a second class and undeserved position. If specialty societies develop these training programs, can they determine the optimal learning format for delivery of the education? What is the mechanism for specialty societies to accredit a program? A criterion would be supportable that describes appropriate options in which training should occur. The vetting of training programs and accredited providers of continuing medical education who have met national/international standards is performed by ACGME and ACCME respectively. Additional vetting would be redundant if these programs need to also be vetted by a member Board. To suggest that member Boards might have the wherewithal to define, describe, validate, and monitor programs outside of nationally/internationally recognized training organizations seems inadvisable. 10. The educational program must be sponsored by an ACGME-accredited institution or participating site. If specialty societies offer an educational program, would they need to be accredited by the ACGME? What is the process for this? If the ACGME accredits specialty societies, would this mean that the societies would need to go through accreditation reviews, etc? This criterion seems to be in conflict with the previous criterion (9). The relationship between ACGME and ACCME accredited organizations is complementary but not necessarily related. To require that an accredited medical specialty s educational program in focused expertise must be sponsored by an ACGME accredited organization appears to add an unnecessary administrative step. 11. Candidates for the area of focused expertise must undergo a rigorous form of external assessment as defined by the ABMS Member Board. What is meant by rigorous form of external assessment as defined by the ABMS? This seems to be too vague. How often would this assessment take place? Who would develop

6 and administer the assessment? Is this recertification? Would this replace the need for comprehensive recertification in the primary area of certification? 12. The ABMS Member Board must describe the associated MOC program. Periodic review would be supportable in theory for the holder of a certificate of focused expertise through a mechanism that is defined and described in the program of study including a time limit for the certificate. However, we do not support the establishment of such additional certification. In summary, certifying focused expertise seems unnecessary, and appears to have more negative unintended consequences than value. Moreover, this may not be a good time for ABMS to add to requirements for additional certification. Perhaps enhancing Maintenance of Certification should be the continued priority of ABMS at this time, as progress seems to be being made in that area. First things first. Thank you for inviting input early in the process of considering standards for a proposed certificate in focused expertise. CMSS is pleased to comment on behalf of our 44 member societies which represent, in the aggregate, 750,000 physicians in the US. Sincerely, Norman Kahn, MD Executive Vice President & CEO MEMBERS American Academy of Allergy, Asthma & Immunology American Academy of Dermatology American Academy of Family Physicians American Academy of Hospice and Palliative Medicine American Academy of Neurology American Academy of Ophthalmology American Academy of Otolaryngology Head and Neck Surgery American Academy of Pediatrics American Academy of Physical Medicine and Rehabilitation American Association of Clinical Endocrinologists American Association of Neurological Surgeons/Congress of Neurological Surgeons American College of Cardiology American College of Emergency Physicians American College of Medical Genetics American College of Obstetricians and Gynecologists American College of Occupational and Environmental Medicine American College of Physicians American College of Preventive Medicine American College of Radiology American College of Rheumatology American College of Surgeons American Epilepsy Society American Gastroenterological Association American Geriatrics Society American Medical Informatics Association American Psychiatric Association American Society of Anesthesiologists American Society of Clinical Oncology American Society for Clinical Pathology American Society of Colon and Rectal Surgeons American Society of Hematology American Society of Nephrology American Society of Plastic Surgeons American Society for Radiation Oncology American Society for Reproductive Medicine American Urological Association North American Spine Society Society of Critical Care Medicine Society of Gynecologic Oncology Society of Hospital Medicine Society of Interventional Radiology Society of Nuclear Medicine and Molecular Imaging Society of Thoracic Surgeons ASSOCIATE MEMBERS Accreditation Council for Continuing Medical Education Accreditation Council for Graduate Medical Education Alliance for Continuing Education in the Health Professions American Board of Medical Specialties American Osteopathic Association Association of American Medical Colleges Association for Hospital Medical Education Federation of State Medical Boards National Board of Medical Examiners

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