November 16, Dear Dr. Berwick:

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1 November 16, 2010 Don Berwick, MD Administrator Centers for Medicare and Medicaid Services Department for Health and Human Services Attn: CMS-6028-P P.O. Box 8020 Baltimore, MD RE: Medicare, Medicaid, and Children s Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers Dear Dr. Berwick: On behalf of our 78,000 member physical therapists, physical therapist assistants, and students of physical therapy, the American Physical Therapy Association (APTA) appreciates the opportunity to comment on the proposed rule regarding screening requirements, application fees, temporary enrollment moratoria, payment suspensions and compliance plans for providers and suppliers. Physical therapists provide services in private practice settings, hospitals, skilled nursing facilities, rehabilitation agencies, comprehensive outpatient rehabilitation facilities, home health agencies, and other entities, and therefore have a significant interest in this rule. In the rule CMS proposes to designate provider and supplier categories that would be subject to certain screening procedures based on CMS s assessment of fraud, waste and abuse risk of the provider or supplier category. Specifically, there are 3 levels of risk: limited, moderate, and high and each provider/supplier category is assigned to one of these levels. We support CMS s decision to place physicians, physical therapists, nonphysician practitioners, and medical clinics and group practices in the limited risk category. In the rule, CMS specifically references physicians and non-physician practitioners as being in the limited list level. Since non-physician practitioners is a term that is typically used to describe nurse practitioners, clinical nurse specialists and physicians assistants, we recommend that CMS clearly state that health care 1

2 professionals, such as physical therapists, also are placed in this category. Physical therapists are licensed in all states and clearly do not pose an elevated risk to the Medicare program. In the moderate level of risk category, CMS includes currently enrolled DMEPOS suppliers and in the high risk category CMS places prospective DMEPOS suppliers. We strongly urge CMS to amend this category to exempt physicians, physical therapists in private practice and other professionals who enroll as DMEPOS suppliers so that they can provide items to their patients as an integral part of their practice. Physical therapists provide orthotics, ambulatory aids, and mobility assistance devices to the patients they serve to help them improve their function. These items become an integral part of the treatment plan for the patients who need them. Physical therapists in private practice (PTPPs) enroll in the Medicare program, obtain individual provider numbers, and bill Medicare directly for the outpatient therapy services they furnish. Currently, if a physical therapist in private practice bills Medicare for DMEPOS items, the therapist must obtain a National Supplier Clearinghouse (NSC) supplier number in addition to his or her individual National Provider Identifier (NPI). Physicians, physical therapists in private practice and other professionals who also enroll as DMEPOS suppliers to provide items as a integral part of their plan of care, should be placed in the limited risk category when enrolling as a DMEPOS supplier. We strongly urge CMS to make this change in the final rule. DMEPOS items are provided by physical therapists as an integral part of their physical therapy plan of care. The clinical judgment and expertise of the physical therapist is critical in selecting a particular DMEPOS item for the patient and is based on the therapist s evaluation of the individual patient. The physical therapist ensures that the item is appropriate to achieve the patient s functional goals, is properly sized and fitted for the patient, and that the patient and/or caregiver is educated in the proper use of the item. In many cases, it is essential that the patient have timely access to these items because the DMEPOS item may be necessary to immobilize and support an injured body part or to facilitate safe mobility or post-surgical recovery. For example, physical therapists often provide patients with orthotics to immobilize a body part, such as fracture braces for humeral fractures, air casts for ankle sprains, or static wrist orthotics for carpal tunnel syndrome. When a physical therapist is treating a patient with a fracture or a sprain, it is necessary to immediately provide the patient with the orthotic to immobilize the injury. It would be unsafe and clinically inappropriate to delay the patient s access to items such as orthotics or ambulatory support devices. Physical therapists also use orthotics to facilitate or augment a patient s movement. It is common for a patient who has had a stroke to develop weakness in his or her ankle dorsiflexors, resulting in a foot drop during the swing phase of gait. Physical therapists provide the patient with an ankle-foot orthosis to facilitate movement at the ankle so the patient will not risk tripping or stumbling during ambulation. Patient falls frequently result in further injury and a cascade of other adverse events. By fitting the patient with the appropriate orthosis in the office, the physical therapist can proceed with gait training 2

3 to assess whether there are sensory or skin problems and determine whether the orthosis allows the patient to ambulate properly. Physical therapists are licensed by the state in which they practice and thus are already subject to numerous state regulatory and other requirements. As licensed health care providers in every jurisdiction in which they practice, physical therapists are fully accountable for all their professional actions. Furthermore, physical therapists have been educated in programs accredited by the Commission on Accreditation of Physical Therapy Education (CAPTE), which is recognized by the U.S. Department of Education and the Commission on Recognition in Postsecondary Accreditation (CORPA). We recognize that these enrollment safeguards are proposed in response to problems with entities that were not well regulated providing services to Medicare beneficiaries. We agree that it is important to have standards in place to protect the safety of Medicare beneficiaries and to ensure that Medicare beneficiaries receive quality services. However, these enrollment standards should be aimed at commercial suppliers, not individual practitioners who are delivering medically necessary DMEPOS to their patients in their offices. As the Center for Medicare and Medicaid Services (CMS) develops additional supplier enrollment standards, APTA strongly urges you to ensure physical therapists can continue to provide these items to their patients in their practices and that this requirement does not diminish beneficiary access to medically necessary items. In most physical therapist practices, DMEPOS items make up a very small portion of the Medicare-covered services furnished by the therapist. Thus, if the enrollment standards are financially and administratively onerous, it will not be feasible for physical therapists to continue to provide these services to their patients. With this background in mind, the comments below address the following provisions that do not make sense in the context of physical therapist s practice. Application fee The ACA requires the Secretary to impose an application fee on each institutional provider of medical or other items or services or supplier to cover the costs of enrollment screening and related program-integrity activities. The ACA excludes eligible professionals, such as physicians, nurse practitioners, and physical therapists from paying an enrollment application fee. CMS proposes to define institutional provider of medical or other items or services or supplier as any health care provider that bills Medicare, Medicaid, or CHIP on a fee-for-service basis, with the exception of Part B medical groups or clinics and physician and non-physician practitioners who submit the CMS- 855I enrollment from to enroll in Medicare. We strongly recommend that CMS clarify in the final rule that physical therapists in private practice are also exempt from the enrollment fee. Physical therapists in private practice enroll in the program using the 855I form and are included in the list of eligible professionals under the statute. 3

4 Also, as described above, some physical therapists in private practice also enroll as DMEPOS suppliers in order to provide DMEPOS items to their patients as an integral part of their patient care. We strongly recommend that CMS exempt physicians, physical therapists in private practice and other health care professionals from the application fee requirement when they enroll as DMEPOS suppliers with the National Supplier Clearinghouse. Clearly, Congress intended that eligible professionals be exempt from these fees in providing services and items in the course of care for their patients. In most physical therapist practices, DMEPOS items make up a very small portion of the Medicare-covered services furnished by the therapist. Thus, if enrollment fees are required, physical therapists will be discouraged from continuing to provide these important services to their patients. Temporary Moratoria on Enrollment of Medicare Providers Under the proposed rule CMS would have the authority to impose a moratorium on the enrollment of new Medicare providers and suppliers in 6 month increments where 1) CMS identifies a trend associated with a high risk of fraud, waste or abuse (e.g. rapid increase in enrollment applications in a category); 2) a State Medicaid program has imposed a moratorium; 3) a State has imposed a moratorium on enrollment in a particular geographic region; or 4) CMS identifies a particular potential for fraud, waste or abuse of a particular provider or supplier type or geographic area. We have serious concerns with imposing moratorium s on enrollment of providers and suppliers. Specifically, CMS references a rapid increase of enrollment applications as one reason for a moratorium. In the physical therapy domain, regulations have changed over the past several years that have resulted in a rapid increase of enrollment applications for physical therapists in private practice. In particular, there has been a shift from outpatient hospital settings to private practice settings for the provision of outpatient physical therapy services. Also, rehabilitation agencies have been designated as Tier 4 for survey and certification, and therefore it is not feasible for a new practice to open as a rehabilitation agency. As a result of these changes, we have seen a significant increase of enrollment in physical therapists in private practice, which is warranted. If CMS were to impose a moratorium on these practices because of increased enrollment numbers, patient access to physical therapy would be limited, particularly as more individuals receive coverage due to health care reform provisions. In addition to enrolling as physical therapists in private practice, some physical therapists also enroll as DMEPOS suppliers to furnish items to their patients as part of their plan of care, as described above. If CMS were to establish a moratorium on DMEPOS suppliers in a particular geographic region, this could potentially prevent new physicians, physical therapists in private practice, and other health care professionals from providing DMEPOS items to their patients. Physical therapists provide orthotics, ambulatory aids, and mobility assistance devices to the patients they serve to help them improve their function. These items become an integral part of the treatment plan for the patients who need them. In many cases, it is essential that the patient have timely access to these items because the DMEPOS item may be necessary to immobilize and support an injured body 4

5 part or to facilitate safe mobility or post-surgical recovery. Therefore, if CMS were to establish a moratorium on DMEPOS suppliers, it would be essential for CMS to exempt physicians, physical therapists, and other health care professionals who enroll as DMEPOS suppliers to provide items to their patients. Any Referring Professional Must Be Medicaid Enrolled In the rule CMS proposes ( )s that any physician or other professional ordering or referring services for Medicaid beneficiaries must be enrolled as a participating provider by the State in the Medicaid program. Currently, this requirement does not apply to physicians. If this provision becomes law and takes effect as of March 23, 2011, many other providers, such as physical therapists, who may receive physician referrals to provide services and supplies could potentially be subject to suspension of payments. In addition, essential DMEPOS items that are ordered for patients could be denied. Many providers and patients could be adversely affected. This could have a trickle-down effect on numerous Medicaid programs, including but not limited to, school-based health services which rely on certifications from physicians and other providers who are currently not required to be Medicaid enrolled providers. Suspension of Payments Section 6402(h) of ACA authorized the Secretary to suspend payments to a provider or supplier pending an investigation of a credible allegation of fraud unless the Secretary determines there is good cause not to suspend payments. CMS proposes to define a credible allegation of fraud to include an allegation from any source, including but not limited to fraud hotline complaints, claims data mining, patterns identified through provider audits, civil false claims cases, and law enforcement activities. We have serious concerns with the broad definition of credible allegation of fraud. This definition is so broad that providers who are wrongly accused of fraud, could be subject to suspension of payments. Based on this definition, a phone call on a hotline could result in suspension of payments to the provider pending an investigation. There could be instances when these claims are unwarranted. CMS proposes several good cause exceptions that would prevent the suspension of payments. In addition to those proposed, CMS states that it is considering as an additional good cause exception, to be when a suspension has been in place for a specific length of time, such as 2 years or 3 years, and the investigation has not been resolved. APTA is significantly concerned with the fact that a provider could be investigated for 2-3 years or possibly longer with no affirmative determination that that provider is guilty of any wrongdoing. In the interim, that provider s payment would be suspended for several years. A payment suspension that would last this length of time would certainly put a provider out of business, even though it is ultimately determined that the provider did not commit fraud. Such a result would be unjustified and unfair. Although providers who have had their Medicare billing privileges revoked have due process rights under , state laws control Medicaid due process rights ( ). 5

6 State laws vary and many can have a time consuming appeals process. Thereby, the provider could be forced out of business in defending a claim for reinstatement of billing privileges under Medicaid and/or CHIP. This, in turn, could have serious ramifications on individuals access to care, especially in those geographic areas in which there are limited Medicaid health providers (or those health providers that solely rely on Medicaid and/or Medicare patients). States also have different enforcement entities which may have varying notice and due process requirements. Federal law enforcement agencies can also investigate Medicaid fraud and abuse issues. The proposed rule does not adequately address due process safeguards for this instance. If this type of case reverts to state law then, again, state remedies may be cumbersome and time-consuming. The proposed amendment gives states authority to immediately release payment suspension if a timely investigation is not ensued by law enforcement, however, timely is not clearly defined. Further, the State can refer the case to yet another enforcement agency without releasing the suspension which causes additional delay to the case. The lowering of the standard of a State s authority to suspend payments from receipt of reliable evidence to merely a credible allegation of fraud is problematic. This could result in suspension of payments on a provider from unscrupulous competitors who can remain anonymous through hotlines and other fraud report mechanisms. What constitutes a high risk provider is not clearly defined. Some providers may be obviously at high risk based on the history of the entity; however, others could be unfairly categorized as high risk without a more clear assessment of high risk criteria. Ethics and Compliance Programs Section 6101(a) of the ACA mandates that a provider of medical or other items or services or a supplier, as a condition of enrollment in Medicare, Medicaid or CHIP, establish a compliance program that contains certain core elements established by the Secretary for providers in a particular industry. CMS is interested in receiving comments on the use of the seven elements of an effective compliance and ethics program described in Chapter 8 of the U.S. Federal Sentencing Guidelines Manual as the basis for the core elements. As CMS develops the compliance programs, it would be helpful to review the voluntary compliance programs developed by the Office of Inspector General of HHS. While we recognize that a compliance program can be an important tool for providers, CMS needs to recognize the financial and staffing resource constraints faced by smaller practices and providers. There should not be a one size fits all approach to compliance programs, especially for small practices. Due to staffing resources, it may not be feasible for a small practice to implement the same type of full scale, structured compliance program that an institutional setting (e.g. hospital) could implement. The applicability of the program should depend on the circumstances and resources of the particular practice. 6

7 We appreciate the opportunity to comment on this regulation and would welcome the opportunity to discuss these issues with you in greater depth. If you have any questions, please contact Gayle Lee, Director of Federal Payment Policy and Regulatory Affairs at or Sincerely, R. Scott Ward, PT, PhD President 7