June 21, Harry Feliciano, MD, MPH Senior Medical Director Part A Policy Palmetto GBA PO Box (JM) AG-275 Columbia, SC 29202

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1 June 21, 2018 Harry Feliciano, MD, MPH Senior Medical Director Part A Policy Palmetto GBA PO Box (JM) AG-275 Columbia, SC Submitted electronically: A.Policy@PalmettoGBA.com RE: Proposed LCD DL37774: Supervised Exercise Therapy for the Treatment of Peripheral Arterial Disease with Symptomatic Lower Extremity Intermittent Claudication Dear Dr. Feliciano: On behalf of our more than 100,000 member physical therapists, physical therapist assistants, and students of physical therapy, the American Physical Therapy Association (APTA) submits the following comments on Palmetto GBA s Draft Local Coverage Determination (LCD) DL37774, Supervised Exercise Therapy (SET) for the Treatment of Peripheral Arterial Disease (PAD) with Symptomatic Lower Extremity Intermittent Claudication. The mission of APTA is to build a community to advance the physical therapy profession to improve the health of society. Physical therapists play a unique role in society in prevention, wellness, fitness, health promotion, and management of disease and disability by serving as a dynamic bridge between health and health services delivery for individuals across the age span. While physical therapists are experts in rehabilitation and habilitation, they also have the expertise and the opportunity to help individuals improve overall health and prevent the need for otherwise avoidable health care services. Physical therapists roles may include education, direct intervention, research, advocacy, and collaborative consultation. These roles are essential to the profession s vision of transforming society by optimizing movement to improve the human experience. APTA fully supports SET, including physical therapy, for Medicare beneficiaries with PAD. Physical therapists are licensed health professionals who evaluate and treat Medicare beneficiaries in a variety of practice settings including private practices, hospitals, skilled nursing facilities (SNF), home health agencies, rehabilitation agencies, and comprehensive outpatient rehabilitation facilities. Within these settings, physical therapists play a vital role in the assessment and management of cardiovascular conditions, as they provide individualized

2 exercise techniques and promote increased function for patients. As a result, we are very interested in the impact this LCD will have on care for Medicare beneficiaries with PAD. Physical therapists evaluate patients needs by gathering data on medical history and other relevant factors such as health habits and comorbidities, and then identify risk factors and behaviors that may impede optimal functioning. The physical therapist s evaluation and subsequent plan of care reflects the chronicity or severity of the current problem, the possibility of multisite or multisystem involvement, the presence of preexisting systemic conditions or diseases, and the stability of the condition. Physical therapists consider the probability of prolonged impairment, activity limitations, and participation restrictions; the living environment; potential discharge destinations; and social support when developing the plan of care. While we reiterate our support for the ability of PAD beneficiaries to receive SET, APTA continues to take issue with several provisions codified in the National Coverage Determination (NCD) 30.35, and now proposed LCD, which refers only to SET in the treatment of PAD in the lower extremities. We also have concerns that several of the SET program requirements included within DL37774 are lacking in clarity, which could lead to seemingly improper payment denials. Pursuant to the Medicare Program Integrity Manual, Chapter 13, Section 13.5, LCDs must be clear and concise and not restrict or conflict with NCDs or coverage provisions in interpretive manuals. 1 As discussed in more detail below, we encourage Palmetto to refine and modify several of the provisions included within the draft LCD. APTA also strongly urges Palmetto to clarify within the LCD and any related policy articles that beneficiaries participating in a SET program are not precluded from receiving additional therapy, such as physical therapy, should they have activity limitations and participation restrictions that may or may not be related to their cardiovascular status (e.g. stroke, congestive heart failure, etc.). Coverage Indications, Limitations, and/or Medical Necessity APTA supports Palmetto s recommendation to use the concepts contained within the World Health Organization s (WHO) International Classification of Functioning, Disability, and Health (ICF) to communicate the patient-centered information describing the symptoms and conditions of each beneficiary and encourages Palmetto to finalize this recommendation. Non-Covered Indications As stated within the NCD, and echoed in Palmetto s LCD, for beneficiaries who have absolute contraindications to exercise, as determined by their primary attending physician, SET for PAD will not be covered. APTA requests that Palmetto clarify within the LCD or related guidance documentation that Palmetto medical review staff would rely upon to determine whether a beneficiary does or does not have absolute contraindications to exercise. APTA is concerned that this language within the policy will be misinterpreted, and could be used as justification to deny SET for beneficiaries who suffer from PAD with symptomatic lower extremity intermittent claudication and who would greatly benefit from therapy. For example, this could be used to deny a SET program even when it is clear that the program is appropriate and would benefit the beneficiary. 1 Medicare Program Integrity Manual, Chapter 13, Section Guidance/Guidance/Manuals/Downloads/pim83c13.pdf Accessed June 13,

3 Assessing Benefits and Harms of Each SET Session APTA requests that Palmetto clarify its proposed policy related to the assessment of benefits and harms of SET. Specifically, we recommend that Palmetto issue guidance on what constitutes an assessment of benefits and harms of SET to ensure providers have an appropriate understanding of the documentation requirements. Qualified Auxiliary Personnel Palmetto references within the draft LCD the NCD s policy on qualified auxiliary personnel, which states that SET must be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD. In clarifying the definition of qualified auxiliary personnel, CMS s SET for PAD Decision Memorandum, dated May 25, 2017, states that while physical therapists are not included in the list of non-physician practitioners, they may participate as qualified auxiliary personnel who may be able to deliver the service. 2 Here, Palmetto s draft LCD includes an additional constraint on the definition of qualified auxiliary personnel, not included within the NCD, stating the auxiliary personnel delivering SET to a given beneficiary must be those providers whose scope of practice, keeping in mind all relevant national and local laws and regulations, includes making the assessments of benefit and risk included in the plan of care for that particular beneficiary. APTA requests that Palmetto delete the second sentence of the Qualified Auxiliary Personnel paragraph included within the draft LCD. The language put forth by CMS in the NCD clearly delineates the types of providers qualified to furnish SET, whereas the draft LCD language is vague, and thus subject to misinterpretation by Palmetto s medical review staff as well as providers, which could constrain the number of providers willing to furnish a SET program for PAD. For example, we presume that when a physical therapist who makes an assessment of benefit and risk included in the plan of care and then directs and supervises a physical therapist assistant in performing elements of the plan of care, this would be in line with the outlined NCD policy. However, due to ambiguity with the language, Palmetto s policy intentions are unclear. Therefore, to ensure beneficiary access to SET is not inappropriately restricted, APTA recommends Palmetto revise its proposed language to mirror the Qualified Auxiliary Personnel definition as referenced in NCD Alternatively, we request that Palmetto clarify its expectations surrounding who may furnish SET in the treatment of PAD in the lower extremities, to better ensure providers, as well as Palmetto medical review staff, understand and correctly apply the policy. Clinicians Responsible for Supervising SET As stated within the NCD, a SET program must be furnished under the direct supervision of a physician, physician assistant (PA), or nurse practitioner/clinical nurse specialist (NP/CNS) who must be trained in both basic and advanced life support techniques. As stated in previous comments, APTA disagrees that the direct supervision of a physician or other non-physician practitioner is necessary for a physical therapist to safely and effectively administer a SET 2 CMS May 25, 2017 Supervised Exercise Therapy Decision Memorandum. rapy&keywordlookup=title&keywordsearchtype=and&list_type=ncd&bc=gaaaacaaqaaa& Accessed June 12,

4 program. The overall effect of requiring this strict supervision level restricted beneficiary access to SET. There is no credible reason for direct supervision by a physician, PA, or NP/CNS when the majority of services that a physical therapist provides do not require such a stringent supervision level. Physical therapists are qualified through education, training, licensure examination, and clinical experience to provide physical therapy services without having a physician onsite, and they do so with great frequency. Physical therapists are sufficiently qualified to furnish SET without the direct supervision of a physician; moreover, physical therapists provide skilled therapy every day across the continuum of care. Therefore, we reiterate our displeasure with requiring physical therapists to be directly supervised when furnishing a SET program and encourage Palmetto to monitor utilization of this therapy in the future to determine whether beneficiary access to SET may be inhibited due to the direct supervision requirement. Components of Treatment APTA appreciates that Palmetto GBA will not stipulate the exercises that may be part of the SET treatment program. We also support Palmetto s statement that the treatment plan should be tailored to the needs of each beneficiary that is evidence-based. Due to the flexibility being afforded to clinicians to develop an individualized care plan, we encourage Palmetto to educate its medical review staff on this policy and that providers are afforded the ability to use their clinical expertise in crafting a treatment plan tailored to the needs of each beneficiary that is evidence-based. This would help to ensure that medical review decisions are made with consideration of the beneficiary s total condition and individual need for care. APTA also requests that Palmetto describe what it would deem relevant evidence to support the reasonableness of the therapeutic approach being used for a beneficiary. We have concerns that without greater clarification, medical review staff will rely on the imprecise term relevant evidence to issue denial decisions despite the medical necessity of the program. Location of Treatment Pursuant to the NCD, a SET program must be conducted only in a hospital outpatient setting or physician s office. While we appreciate that CMS expanded the setting to include a physician s office, APTA believes the setting restrictions could pose an access barrier, as more patients would benefit if the number of settings where SET can be delivered is expanded. As highlighted above, physical therapists already provide treatment in a number of different settings including private practices, hospitals, SNFs, home health agencies, rehabilitation agencies, and comprehensive outpatient rehabilitation facilities. Expanding the number of permissible settings where SET can be furnished would promote accessibility for beneficiaries in need of physical therapy. A substantial number of beneficiaries seek physical therapy due to issues with pain, mobility, or strength, which makes travel difficult. In fact, this may prompt beneficiaries to seek out SET in the first place. Restricting access to SET to a hospital outpatient setting or physician s office may actually hinder beneficiaries from accessing medically necessary services, due to an inability to reach the appropriate facility. It is imperative that Medicare beneficiaries, both those who reside in metropolitan as well as rural areas, have equitable access to health care services. While rural areas are adopting new ways to provide access to clinical expertise, such as through telehealth, access remains limited. 4

5 We urge Palmetto, and CMS, to consider whether it may be more appropriate to expand the number of settings in which a SET program may be delivered, either in a SNF, assisted living facility, or in the beneficiary s home. Discharge from SET The purpose of a LCD is to help avoid situations in which claims are paid or denied without a provider having a full understanding of the basis for payment and denial. 3 Here, Palmetto states that within the LCD that treatment must continue only as long as benefits, as measured by meaningful reductions in activity limitations exceed risks of treatment. For beneficiaries who are not tolerating treatment or progressing as expected, it is encouraged that they be sent back to the referring provider to develop a new treatment strategy for PAD. While APTA acknowledges that Palmetto has recognized a need to further define NCD 20.35, we have concerns that this proposed discharge policy is subject to provider misinterpretation, which could pose an access issue for beneficiaries and/or result in claim denials due to lack of understanding of the policy. Therefore, we recommend that Palmetto clarify this draft policy to better promote continued access to SET for PAD with symptomatic lower extremity intermittent claudication. Education for Medical Review Staff As discussed above, following publication of the final LCD, APTA strongly recommends that Palmetto implement immediate, ongoing education to its medical review staff to ensure reviewers have an appropriate understanding of the new coverage policy and associated documentation requirements. Specifically, we recommend that Palmetto provide detailed education to staff which clarifies that a SET program for symptomatic PAD is covered when the therapy is appropriate. We have concerns that lack of a proper understanding of the policy by medical reviewers could result in inappropriate denials of SET even when it is clear that the program is appropriate and would benefit the beneficiary. Conclusion We thank Palmetto GBA for the opportunity to comment on the draft LCD, Supervised Exercise Therapy for the Treatment of Peripheral Arterial Disease with Symptomatic Lower Extremity Intermittent Claudication (DL37774). APTA is eager to engage in meaningful dialogue and work with Palmetto in developing a payment model that safeguards Medicare beneficiaries access to medically necessary SET. If you have any questions regarding our comments, please contact Kara Gainer, Director of Regulatory Affairs, at karagainer@apta.org or 703/ Thank you for your consideration. Sincerely, Sharon L. Dunn, PT, PhD Board-Certified Clinical Specialist in Orthopaedic Physical Therapy President 3 Medicare Program Integrity Manual, Chapter 13, Section Guidance/Guidance/Manuals/Downloads/pim83c13.pdf Accessed June 13,