(Medicare Benefit Policy Manual)

 An acute myocardial infarction (MI) within the preceding 12 months;   A coronary artery bypass surgery;   Current stable angina pectoris;   Heart valve repair or replacement;   Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting;   A heart or heart -lung transplant.  Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks, on or after Februa ry 18, 2014 for CR and on or after February 9, 2018 for ICR; or,  Other cardiac conditions as specified through a national coverage determination (NCD). The NCD process may also be used to specify non- coverage of a cardiac condition for ICR if coverage is not supported by clinical evidence.   CR and ICR must include all of the following components:   Physician -prescribed exercise. Physician -prescribed exercise means aerobic exercise  combined with other types of exercise (such as strengthening and stretching) as determined to be appropriate for individual patients by a physician each day CR/ICR items and services are furnished.   Cardiac risk factor modification. Cardiac risk factor modification, including education,  counseling, and behavioral intervention, tailored to the  individuals needs.   Psychosocial assessment. Psychosocial assessment means an evaluation of an individuals mental and emotional functioning as it relates to the individuals rehabilitation which includes an assessment of those aspects of an individuals family and home situa tion that affects the individuals rehabilitation treatment, and psychosocial evaluation of the individuals response to and rate of progress under the treatment plan.  Outcomes assessment. Outcomes assessment means an evaluation of progress as it relates  to the individuals rehabilitation which includes all of the following: (i) Evaluations, based on patient -centered outcomes, which must be measured by the physician or program staff at the beginning and end of the program. Evaluations measured by program staff must be considered by the physician in developing and/or reviewing individualized treatment plans. (ii) Objective clinical measures of exercise performance and self -reported measures of exertion and behavior.   Individualized treatment plan. Individualized treatment plan means a written plan tailored  to each individual patient that includes all of the following: (i) A description of the  individuals diagnosis. (ii) The type, amount, frequency, and duration of the items and services furnished under the plan. (iii) The goals set for the individual under the plan. The  individualized treatment plan detailing how components are utilized for each patient,  must be established, reviewed, and signed by a physician every 30 days.  As specified at 42 CFR 410.49(f)(1), the number of CR sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor (MAC).   As specified at 42 CFR 410.49(f)(2), ICR sessions are limited to 72 1-hour sessions (as defined in section 1848(b)(5) of the Act), up to 6 sessions per day, over a period of up to 18 weeks.  CR and ICR Settings:  Medicare Part B pays for CR and ICR in a physicians office or a hospital outpatient setting. All settings must have a physician immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for direct supervision for physician office services, at 42 CFR 410.26, and for hospital outpatient services at 42 CFR 410.27.  Standards for an ICR Program:  To be approved as an ICR program, a program must demonstrate through peer- reviewed, published research that it has accomplished one or more of the following for its patients: (i) Positively affected the progression of coronary heart disease. (ii) Reduced t he need for coronary bypass surgery. (iii) Reduced the need for percutaneous coronary interventions.  An ICR program must also demonstrate through peer- reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before CR services to after CR services: (i) Low density lipoprotein. (ii) Triglycerides. (iii) Body mass index. (iv) Systolic blood pressure. (v) Diastolic blood pressure. (vi) The need for cholesterol, blood pressure, and diabetes medications.   A list of approved ICR programs, identified through the NCD process, will be listed in the Federal Register and is available on the CMS website at https://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/ICR . All prospective ICR sites must apply to enroll as an ICR program site using the designated forms as specified at 42 CFR 424.510, and report specialty code 31 to be identified as an enrolled ICR supplier. For purposes of appealing an adverse determination  concerning site approval, an ICR site is considered a supplier (or prospective supplier) as defined in 42 CFR 498.2.  CR and ICR Physician Standards:  Medical Director. Medical director means the physician who oversees the CR or ICR program at a particular site. The medical director is the physician responsible for a CR or ICR program and, in consultation with staff, is involved in directing the progress of individuals in the program and must possess all of the following: (1) Expertise in the management of individuals with cardiac pathophysiology. (2) Cardiopulmonary training in basic life support or advanced cardiac life support. (3) Be licensed to pract ice medicine in the State in which the CR or ICR program is offered.  Supervising Physician. Supervising physician means a physician that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under CR and ICR programs. Physicians acting as the supervising physician must possess all of the following: (1) Expertise in the management of individuals with cardiac pathophysiology. (2) Cardiopulmonary training in basic life support or advanced cardiac life support. (3) Be licensed to practice medicine in the State in which the CR or ICR program is offered.  (See Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, section 20.10.1, Pub. 100-04, Medicare Claims Processing Manual, Chapter 32, section 140, Pub. 100-08, Medicare Program Integrity Manual, Chapter 10, section 10.2.2.5, for CR and ICR claims processing, coding, and billing requirements.)  240 - Chiropractic Services - General  (Rev. 1, 10-01-03) B3-2250, B3-4118  The term physician under Part B includes a chiropractor who meets the specified qualifying requirements set forth in 30.5 but only for treatment by means of manual manipulation of the spine to correct a subluxation.  Effective for claims with dates of services on or after January 1, 2000, an x-ray is not required to demonstrate the subluxation.  Implementation of the chiropractic benefit requires an appreciation of the differences between chiropractic theory and experience and traditional medicine due to fundamental differences regarding etiology and theories of the pathogenesis of disease.  Judgm ents about the reasonableness of chiropractic treatment must be based on the application of chiropractic principles.  So that Medicare beneficiaries receive equitable adjudication of claims based on such principles and are not deprived of the benefits intended by the law, A/B MACs (B) may use chiropractic consultation in A/B MAC (B) review of Medicare chiropractic claims.   Payment is based on the physician fee schedule and made to the beneficiary or, on assignment, to the chiropractor.  A.  Verification of Chiropractors Qualifications   A/B MACs (B) must establish a reference file of chiropractors eligible for payment as physicians under the criteria in 30.1 .  They pay only chiropractors on file.  Information needed to establish such files is furnished by the CMS RO.  The RO is notified by the appropriate State agency which chiropractors are licensed and whether each meets the national uniform standards.  240.1 - Coverage of Chiropractic Services  (Rev. 1, 10-01-03) B3-2251  240.1.1 - Manual Manipulation  (Rev. 1, 10-01-03) B3-2251.1  Coverage of chiropractic service is specifically limited to treatment by means of manual manipulation, i.e., by use of the hands.  Additionally, manual devices (i.e., those that are hand-held with the thrust of the force of the device being controlled manually) may be used by chiropractors in performing manual manipulation of the spine.  However, no additional payment is available for use of the device, nor does Medicare recognize an extra charge for the device itself.   No other diagnostic or therapeutic service furnished by a chiropractor or under the chiropractors order is covered.  This means that if a chiropractor orders, takes, or interprets an x -ray, or any other diagnostic test, the x-ray or other diagnostic test, can be used for claims processing purposes, but Medicare coverage and payment are not available for those services. This prohibition does not affect the coverage of x- rays or other diagnostic tests furnished by other practitioners under the program.  For example, an x-ray or any diagnostic test taken for the purpose of determining or demonstrating the existence of a subluxation of the spine is a diagnostic x- ray test covered under 1861(s)(3) of the Act if ordered, taken, and interpreted by a physician who is a doctor of medicine or osteopathy.  Manual devices (i.e., those that are hand -held with the thrust of the force of the device being controlled manually) may be used by chiropractors in performing manual manipulation of the spine.  However, no additional payment is available for use of the device, nor does Medicare recognize an extra charge for the device itself.   Effective for claims with dates of service on or after January 1, 2000, an x-ray is not required to demonstrate the subluxation.  However, an x-ray may be used for this purpose if the chiropractor so chooses.  The word correction may be used in lieu of treatment.  Also, a number of different terms composed of the following words may be used to describe manual manipulation as defined above:   Spine or spinal adjustment by manual means;    Spine or spinal manipulation;    Manual adjustment; and    Vertebral manipulation or adjustment.   In any case in which the term(s) used to describe the service performed suggests that it may not have been treatment by means of manual manipulation, the A/B MAC (B) analyst refers the claim for professional review and interpretation.   240.1.2 - Subluxation May Be Demonstrated by X -Ray or Physicians Exam (Rev. 1, 10- 01-03) B3-2251.2  Subluxation is defined as a motion segment, in which alignment, movement integrity, and/or physiological function of the spine are altered although contact between joint surfaces remains intact.   A subluxation may be demonstrated by an x- ray or by physical examination, as described below.  1. Demonstrated by X -Ray  An x -ray may be used to document subluxation.  The x- ray must have been taken at a time reasonably proximate to the initiation of a course of treatment.  Unless more specific x-ray evidence is warranted, an x -ray is considered reasonably proximate if it wa s taken no more than 12 months prior to or 3 months following the initiation of a course of chiropractic treatment.  In certain cases of chronic subluxation (e.g., scoliosis), an older x-ray may be accepted provided the beneficiarys health record indicates the condition has existed longer than 12 months and there is a reasonable basis for concluding that the condition is permanent.  A previous CT scan and/or MRI is acceptable evidence if a subluxation of the spine is demonstrated.   2. Demonstrated by Physical Examination   Evaluation of musculoskeletal/nervous system to identify:   Pain/tenderness evaluated in terms of location, quality, and intensity;   Asymmetry/misalignment identified on a sectional or segmental level;   Range of motion abnormality (changes in active, passive, and accessory joint movements resulting in an increase or a decrease of sectional or segmental mobility); and  Tissue, tone changes in the characteristics of contiguous, or associated soft tissues, including skin, fascia, muscle, and ligament.   To demonstrate a subluxation based on physical examination, two of the four criteria mentioned under physical examination are required, one of which must be asymmetry/misalignment or range of motion abnormality.   The history recorded in the patient record should include the following:   Symptoms causing patient to seek treatment;   Family history if relevant;  Past health history (general health, prior illness, injuries, or hospitalizations; medications; surgical history);  Mechanism of trauma;   Quality and character of symptoms/problem;   Onset, duration, intensity, frequency, location and radiation of symptoms;   Aggravating or relieving factors; and   Prior interventions, treatments, medications, secondary complaints.