(a) Definitions. As used in this section:

Individualized treatment plan means a written plan tailored to each individual patient that includes all of the following:

(i) A description of the individual's 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.

Medical director means the physician who oversees the pulmonary rehabilitation program at a particular site.

Nonphysician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist as those terms are defined in section 1861(aa)(5)(A) of the Act.

Outcomes assessment means an evaluation of progress as it relates to the individual's rehabilitation which includes 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 shortness of breath and behavior.

Physician means a doctor of medicine or osteopathy as defined in section 1861(r)(1) of the Act.

Physician-prescribed exercise means aerobic exercise combined with other types of exercise (such as conditioning, breathing retraining, step, and strengthening) as determined to be appropriate for individual patients by a physician.

Psychosocial assessment means an evaluation of an individual's mental and emotional functioning as it relates to the individual's rehabilitation or respiratory condition which includes an assessment of those aspects of an individual's family and home situation that affects the individual's rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under the treatment plan.

Pulmonary rehabilitation means a physician or nonphysician practitioner supervised program for COPD and certain other chronic respiratory diseases designed to optimize physical and social performance and autonomy.

Supervising practitioner means a physician or nonphysician practitioner that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under pulmonary rehabilitation programs.

(b) General rule—(1) Covered conditions. Medicare Part B covers pulmonary rehabilitation for beneficiaries:

(i) With moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease;

(ii) Who have had confirmed or suspected COVID-19 and experience persistent symptoms that include respiratory dysfunction for at least four weeks;

(iii) Additional medical indications for coverage for pulmonary rehabilitation may be established through a national coverage determination (NCD).

(2) Components. Pulmonary rehabilitation must include all of the following:

(i) Physician-prescribed exercise during each pulmonary rehabilitation session.

(ii) Education or training that is closely and clearly related to the individual's care and treatment which is tailored to the individual's needs and assists in achievement of goals toward independence in activities of daily living, adaptation to limitations and improved quality of life. Education must include information on respiratory problem management and, if appropriate, brief smoking cessation counseling.

(iii) Psychosocial assessment.

(iv) Outcomes assessment.

(v) An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days.

(3) Settings. (i) Medicare Part B pays for pulmonary rehabilitation in the following settings:

(A) A physician's office.

(B) A hospital outpatient setting.

(ii) All settings must have the following:

(A) A physician or nonphysician practitioner 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 or nonphysician practitioner meets the requirements for direct supervision for physician office services, at § 410.26 of this subpart; and for hospital outpatient services at § 410.27 of this subpart.

(B) The necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary (for example, oxygen, cardiopulmonary resuscitation equipment, and defibrillator) to treat chronic respiratory disease.

(c) Medical director standards. The physician responsible for a pulmonary rehabilitation program is identified as the medical director. The medical director, 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 respiratory 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 pulmonary rehabilitation program is offered.

(d) Supervising practitioner standards. Physicians or nonphysician practitioners acting as the supervising practitioner must possess all of the following:

(1) Expertise in the management of individuals with respiratory pathophysiology.

(2) Cardiopulmonary training in basic life support or advanced cardiac life support.

(e) Limitations on coverage: The number of pulmonary rehabilitation 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.

(f) Effective date. Coverage for pulmonary rehabilitation program services is effective January 1, 2010.