CMS National Coverage Policy

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1 LCD ID Number L32764 LCD Title Pulmonary Rehabilitation (PR) Programs Contractor s Determination Number L32764 AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Primary Geographic Jurisdiction Arkansas, Louisiana, Mississippi, Colorado, Texas, Oklahoma, New Mexico Oversight Region Central Office Original Determination Effective Date For services performed on or after 08/13/2012 Original Determination Ending Date Revision Effective Date For services performed on or after Revision Ending Date CMS National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determination(s) or payment policy rules and regulations for pulmonary rehabilitation services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for pulmonary rehabilitation services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies regarding pulmonary rehabilitation services are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site: Medicare Benefit Policy Manual Pub ; Chapter 15, Section 231. Medicare National Coverage Determinations Manual Pub Section Medicare Claims Processing Manual Pub ; Chapter 32, Sections: 140.4, Pulmonary Rehabilitation Program Services Furnished On or After January 1, Correct Coding Initiative Medicare Contractor Beneficiary and Provider Communications Manual Pub , Chapter 5. Social Security Act (Title XVIII) Standard References, Sections:

2 1862 (a)(1)(a) Medically Reasonable & Necessary (a)(1)(d) Investigational or Experimental (a)(6) Personal Comfort Items (a)(7) Screening (Routine Physical Checkups) (e) Incomplete Claim. 42 CFR Services for PR must be medically reasonable and necessary for the treatment of pulmonary illness. Patients who require pulmonary rehabilitation treatment will meet all of the following criteria: A medical diagnosis of a chronic, but stable respiratory condition that is under optimal medical management (See the ICD-9-CM Codes That Support Medical Necessity section below). Within three months prior to initiation of PR, Pulmonary Function Tests (PFTs) meeting the definition of COPD GOLD Classification II, III, or IV (minimally, an (FEV 1/FVC < 70 percent; FEV 1 <80 percent). The patient has a diagnosis of either emphysema or chronic bronchitis. Exhibits disabling symptoms that impede the patient s level of function. Demonstrated physical ability to participate be motivated and committed to the prescribed pulmonary rehabilitation program. Expectation of a measurable improvement (respiratory and physically) within a reasonable time frame. Each physician-prescribed plan of care for a qualified beneficiary in a pulmonary rehabilitation program must include the following minimal elements (see IOM , Chapter 15, Section 231 for complete description): Physician-prescribed aerobic exercise; each visit (PR session) must include aerobic exercise designed to increase endurance and strength. Education or training designed to assist in achievement of improved quality of life and independence. Psychosocial assessment including a written evaluation of an individual s mental and emotional functioning as it relates to the individual s rehabilitation. An outcomes assessment including objective clinical measures. An individual treatment plan that is established and reviewed by a physician every 30 days. The goal of PR is not to achieve a maximum exercise tolerance but to ultimately transfer the responsibility of care from the clinic, hospital or doctor to home care by the patient, the patient s family or the patient s caregiver. Unless the patient will be able to continue an ongoing self-continuation program at home, there may be only a temporary benefit from the treatment. The endpoint of treatment is not when the patient achieves maximal exercise tolerance or stabilizes, but when the patient or his attendant is able to continue the PR at home. Medicare does not cover maintenance care. As described in this policy, PR services may use a multidisciplinary team approach with Respiratory Therapists (RTs), Registered Nurses (RNs), Physical Therapists (PTs), Occupational Therapists (OTs), or other appropriate professionals or any combination of these services/disciplines. A duplication of services occurs when there is a direct overlap of services or when a single service can provide the care. When there is an order for the same treatment modality or procedure for multiple clinicians (e.g., therapeutic exercise, breathing retraining), each clinician is expected to provide skilled treatment that reflects his unique skills and knowledge without exceeding the patient s skilled care needs. The treatment is directed toward each clinician s patient-specific goals. This is critical to establish that the services provided by various disciplines are reasonable, necessary and distinct from each other.

3 Medical director requirements include all of the following: Is responsible and accountable for the pulmonary rehabilitation program, including oversight of the PR staff. Is responsible and accountable for the pulmonary rehabilitation program, including oversight of the PR staff. Must re-evaluate each patient and revise the plan of care for each patient at least every 30 days. Must be either a Medical Doctor (MD) or a Doctor of Osteopathy (DO). Is involved substantially, in consultation with staff, in directing the progress of the individual in the program including direct patient contact related to the periodic review of his treatment plan. Has expertise in the management of individuals with respiratory pathophysiology and cardiopulmonary training and/or certification including basic life support. Is licensed to practice medicine in the state in which the pulmonary rehabilitation program is offered. The supervising physician must be a physician (MD or DO) and must be on site, able and accessible for medical consultation and immediately available at all times that patients are under treatment; immediately available means that the responsible and accountable physician must be able to respond to an emergency in less than one minute. Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier. Limitations of Coverage Coverage for pulmonary rehabilitation services is provided for up to 36 sessions occurring no more frequently than two sessions per day. An additional 36 sessions (maximum of 72 sessions/lifetime) may be approved if the beneficiary fails to achieve the level of functioning set out by the medical director in the plan of care and has the potential for significant progress. These services are covered by Medicare when provided in the locations described in the Bill Type/Revenue or the Place of Service section below. Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for Medical Necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determination, and all Medicare payment rules. As published in CMS IOM , Section , in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: Safe and effective. Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).

4 Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: - Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. - Furnished in a setting appropriate to the patient's medical needs and condition. - Ordered and furnished by qualified personnel. - One that meets, but does not exceed, the patient's medical needs. - At least as beneficial as an existing and available medically appropriate alternative. Coding Information Bill Type Codes Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 013x 085x Hospital Outpatient Critical Access Hospital Revenue Codes Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Note: The contractor has identified the Bill Type and Revenue Center codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Center codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Center codes. Providers are encouraged to refer to the CMS Internet-Only Manual, Pub , Claims Processing Manual, for further guidance. Place of service (POS): Physician s office (11). Hospital outpatient (22) Other Therapeutic Services - Pulmonary Rehabilitation 096X Professional Fees - General Classification CPT/HCPCS Codes Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.

5 G0424 Pulmonary rehab w exer ICD-9 Codes that Support Medical Necessity Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims. The CPT/HCPCS codes included in this LCD will be subjected to procedure to diagnosis editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Medicare is establishing the following limited coverage for CPT/HCPCS code G0424: Covered for: SIMPLE CHRONIC BRONCHITIS - MUCOPURULENT CHRONIC BRONCHITIS OBSTRUCTIVE CHRONIC BRONCHITIS WITHOUT EXACERBATION OTHER CHRONIC BRONCHITIS OTHER EMPHYSEMA 496 CHRONIC AIRWAY OBSTRUCTION NOT ELSEWHERE CLASSIFIED Diagnoses that Support Medical Necessity A medical diagnosis of a chronic, but stable respiratory condition, which is under optimal medical management, with documented Pulmonary Function Tests (PFTs) results of FEV 1/FVC < 70 percent or FEV 1 <80 percent. ICD-9 Codes that DO NOT Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity All diagnoses not listed in the ICD-9-CM Codes That Support Medical Necessity section of this LCD. Other Information Documentation Requirements Documentation supporting medical necessity should be legible, maintained in the patient s medical record and made available to Medicare upon request. All documentation must demonstrate clinical rationale for skilled intervention. Clinicians are required to document all activities, tasks, instruction and treatment provided. This documentation must be done each time the patient receives any PR service. The patient s medical record must contain documentation that fully supports the medical necessity for PR services as covered by Medicare (see Indications and Limitations of Coverage and/or Medical Necessity section). This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures.

6 It may be reasonable and necessary for multiple clinicians, ordered by the physician, to address a patient s particular needs. Each clinician must then perform an individualized skilled evaluation within his scope of practice and his specific area of expertise. Each of the individualized evaluations will identify the problems leading to the development of a specific plan of treatment and the setting of specific goals. Physician Orders All PR services must be ordered by a physician or limited license practitioner. All treatment orders for PR therapies must include the following: Specification of the discipline, type, frequency and duration of the procedure, modality or activity. Verbal and telephone orders that are cosigned and dated by the physician prior to billing the claim. A blanket PR order is not acceptable. Discharge Criteria A patient should be discharged from PR services when the documentation shows any of the following: The patient, his family or the patient s caregiver can assume responsibility for continuing the PR at home. There is minimal or no potential for material gains or significant progress. The patient is non-compliant with the established plan of care. The patient has achieved the clinical goals as described in the initial plan of care. The total number of timed minutes must be documented in the medical record using start and stop times. Appendices Utilization Guidelines When billing for G0424, the duration of treatment must be at least 31 minutes. Two sessions of pulmonary rehabilitation services may only be reported in the same day if the duration of treatment is at least 91 minutes (first session would account for 60 minutes and the second session would account for at least 31 minutes). If several shorter periods of pulmonary rehabilitation services are furnished on a given day, the minutes of service during those periods must be added together for reporting in onehour session increments. A maximum of two sessions per day may be reported, regardless of the total duration of pulmonary rehabilitation services. The federal regulations do not describe the limitations on the duration of a course of pulmonary rehabilitation, leaving that determination up to the contractors. The optimal duration of a course of pulmonary rehabilitation therapy is also not described in published articles or guidelines but should be tailored to the medical needs of the individual beneficiary. Furthermore, each beneficiary is limited to a lifetime maximum of 72 PR sessions by the regulation. If the patient meets the entry criteria described in the Indications and Limitations of Coverage and/or Medical Necessity section, the PR program usually provides a total of 36 PR sessions over a period of 18 weeks; the frequency and duration of each course of rehabilitation may be individualized, but the

7 provider must be cognizant of the lifetime maximum number of sessions.. An additional 36 sessions may be provided if all of the following apply: The physician has re-evaluated the patient and has ordered additional services. This re-evaluation is available for review by Medicare. The patient is expected to show additional significant improvement. Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. Sources of Information and Basis for Decision Pulmonary Rehabilitation for COPD and Other Lung Diseases. Agency for Healthcare Research and Quality, 2006 LaCasse, Y, Goldstein, R, Lasserson, TJ, Martin, S., Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease. Cochran Collaboration. John Wiley & Sons, Ltd, 2006 Niewoehner, D.E., Outpatient Management of Severe COPD. NEJM, 2010, 362(15): pp Ries, A.L., Bauldoff, G.S., Carlin, B.W., et al., Pulmonary Rehabilitation: Joint ACCP/AACVPR Evidence- Based Clinical Practice Guidelines. Chest 2007, 131: pp. 4S-42S. Phurrough, S.E., Salive, M., Lofti, R., Brechner, R.J. Decision Memo for Pulmonary Rehabilitation. (CAG N), Rodriguez-Rosin et al. Global Initiative for Chronic Obstructive Lung Disease: Pocket Guide to COPD Diagnosis, Management, and Prevention, 2009 (obtained April 22, 2010, from Chan, PS, Krumholz, HM, Nichol, G, et al. Delayed Time to Defibrillation After In-Hospital Cardiac Arrest. NEJM, 2008 (1): pp Foglio et al., Is it really useful to repeat outpatient pulmonary rehabilitation programs in patients with chronic airway obstruction?: A two year controlled study. Chest, 2001, 119: Romagnoli et al., Repeated pulmonary rehabilitation in severe disabled COPD patients. Respiration, 2006, 73: Puhan et al., Cochrane Review. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database, 2009, Issue 1. Other Contractor Local Coverage Determinations Outpatient Pulmonary Rehabilitation, TrailBlazer LCD (00400) L1929 Outpatient Pulmonary Rehabilitation, Harvard Pilgrim Healthcare; effective May 27, 2009

8 Novitas Solutions, Inc. JH Local Coverage Determination (LCD) Consolidation, Narrative Justification Most Clinically Appropriate LCD LCDs Compared: L31221, Pulmonary Rehabilitation (PR) Programs, TrailBlazer, CO, NM, TX, OK A/B CMD Rationale: This is the only LCD addressing this therapy. It has a well written Indications/Limitations section with information on criteria required for approving therapy, Medical Director requirements at the facility, and limits on number of visits. Coding, Documentation Requirements, Discharge Criteria, and Utilization Guidelines are all present. Sources of Information and Basis for Decision are also present. L31221 is the most clinically appropriate LCD. Start Date of Comment Period End Date of Comment Period: Start Date of Notice Period 06/28/2012

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