United States: New CMS Coverage Policy for Cardiac Rehabilitation

The Centers for Medicare and Medicaid Services (CMS) has published a new coverage decision (NCD) for cardiac rehabilitation services effective for services performed on or after March 22, 2006. The NCD represents a significant change in reimbursement policy. On February 20, 2001, CMS began an internal review with the assistance of the Office of Inspector General (OIG), the Medicare Coverage Advisory Committee, and the Agency for Healthcare Research and Quality aimed at determining whether the clinical literature supported the delivery of cardiac rehab services for additional clinical indications. As a result, CMS has expanded the clinical indications and total number of allowable sessions for, and duration of, the cardiac rehab benefit.

CMS has been reviewing the medical literature on cardiac rehab and its indications and outcomes for several years. The review culminated in the publication of a proposed NCD in December 2005 and a final NCD in March 2006. The NCD refers to only phase II cardiac rehab programs defined as comprehensive, medically supervised, long-term outpatient programs that are typically initiated one to three weeks after hospital discharge; provide appropriate electrocardiographic (ECG) monitoring; and include medical evaluation, cardiac risk factor modification, education and counseling. CMS has posted the new coverage policy on its website at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=164. The policy replaces section 20.10 in the Medicare National Coverage Determinations Manual (Manual 100-3).

Medicare expanded the clinical indications for cardiac rehab coverage from myocardial infarction (MI), coronary artery bypass surgery (CABG) or stable angina to include heart valve repair/replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or heart-lung transplants. CMS declined to add congestive heart failure (CHF) as an indication. However, CMS signaled that it is waiting for the results of a current U.S.-wide trial on CHF and would reconsider this indication in light of its results. CMS also declined to include the broader term of percutaneous coronary intervention as an indication because this term encompasses clinical interventions that do not have evidence to support coverage.

For an item or service to be covered by Medicare, it must meet one of the statutorily defined benefit categories outlined in the Social Security Act. Cardiac rehab is covered as "incident to" a physician’s professional services. Because CMS deleted special physician supervision requirements from the NCD, such requirements are now consistent with the broader Medicare scheme for "incident to" coverage. Accordingly, CMS requires that cardiac rehab programs generally function under the direct supervision of a physician—the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. By dropping specific physician supervision requirements for the cardiac rehab benefit, CMS folds cardiac rehab requirements back into the general rule of the Medicare Benefit Policy Manual. Specifically, CMS assumes the physician supervision requirement is met when the services are performed on hospital premises. However, if services are furnished outside the hospital, they must be rendered under the direct personal supervision of the physician treating the patient.

Further, the supervision requirement need not be met by the ordering physician alone. CMS deleted its proposed December 2005 statement that the "incident to" physician is the ordering physician. This change implies that numerous physicians could fulfill the "incident to" requirement—the primary care physician, the referring cardiologist or the cardiac surgeon depending upon local medical practices. However, in light of prior OIG reviews and audits of "incident to" requirements, we recommend that programs maintain the documentation not only of the physician’s order for cardiac rehab but of the personal involvement of the physician overseeing the cardiac rehab regimen and the physician who will assess the patient’s progress and, who, when appropriate, will make changes in the patient’s treatment plan.

Under the NCD, services provided in connection with a cardiac rehab program may be considered reasonable and necessary for up to 36 sessions and for a period of 12 to 18 weeks. CMS found that programs typically require patients to participate at least twice a week to gain clinical benefits and that two to three sessions per week is most common. CMS limited coverage to a certain number of sessions based on the majority of programs reviewed. Previously CMS allowed reimbursement only up to and including 12 weeks, not to exceed 36 sessions. Now CMS has included an expanded benefit that goes beyond 18 weeks and up to 36 weeks, not to exceed 72 sessions, thereby doubling the duration and number of sessions. In addition, the 72-session limit is tied to each qualifying cardiac episode and is not a lifetime limit.

CMS has given contractors the discretion to establish rules regarding the expanded benefit and to determine when coverage beyond 36 weeks would be warranted. This suggests contractors may create exit criteria for cardiac rehab that can be systematically applied to beneficiaries in their jurisdiction to determine when extending a program is reasonable and necessary. CMS has given contractors this authority despite the fact that the NCD removed language regarding specific exit criteria from cardiac rehab because CMS was unable to find evidence to support using such criteria. As a result, if contractors create different standards or establish different criteria for the approval of the extended benefit, regional disparities may arise.

The NCD also presumes that patients should begin rehabilitation within one to three weeks of hospital discharge. Clinical evidence trends to enrolling patients in programs at this early stage. However, CMS has not made one to three weeks a limitation but rather has included the presumption to reflect how phase II cardiac rehab should generally be provided.

Previously CMS did not provide a definition of cardiac rehab aside from describing it as an exercise program for cardiac patients. In contrast, the NCD adopts the broad definition of cardiac rehab used by the U.S. Public Health Service that encompasses various lifestyle modification approaches if they include five required components:

• medical evaluation

• a program to modify cardiac risk factors (e.g., nutrition, smoking, weight, stress)

• prescribed exercise

• education

• counseling

CMS does not articulate a clear set of operational standards for the delivery of cardiac rehab services, suggesting rather that such standards are more appropriately established by the medical community.

Similarly, previous CMS policy extensively addressed the use and benefits of psychotherapy, psychological testing, and physical and occupational therapy in cardiac rehab programs. The NCD deletes all such specific references even though such services remain important parts of comprehensive and multidisciplinary programs. Again, CMS stated that it does not wish to be "prescriptive regarding the precise amount of time that must be spent on each component of the program which allows for flexibility and tailoring based on patient needs." At the same time, the NCD reaffirms that the components within a comprehensive program are not separately billable unless the patient qualifies independently for additional services under the current scope of Medicare benefits. Accordingly, being part of a cardiac rehab program does not preclude a patient from independently qualifying for additional services. However, services that are provided "incident to" physician services require direct physician supervision. Physical therapists, psychologists or nutritionists, for example, cannot provide such services under the cardiac rehab benefit and bill for them separately unless beneficiaries independently qualify for additional services under the broader Medicare benefit.

Finally, CMS continues to require that facilities have available for immediate use the necessary cardio-pulmonary, emergency, diagnostic and therapeutic life-saving equipment corresponding to medical community standards, such as oxygen, cardiopulmonary resuscitation equipment or defibrillators. CMS continues to require that personnel must be trained in both basic and advanced life support techniques and in exercise therapy for coronary disease, and that programs must be staffed to protect patient safety. Given its concern about being overly prescriptive on clinical standards, CMS removed language from the current NCD specific to the use of ECG rhythm strips. The NCD leaves this decision to clinicians or a Medicare local contractor.

Providers should review internal clinical and billing protocols to ensure they are consistent with the NCD and Medicare "incident to" coverage requirements. Providers should also allow clear, independent qualifying assessments for many of the ancillary services for patients who need additional support, particularly in the behavioral, nutritional, or physical and occupational therapy areas. In addition, providers should watch for local coverage determinations (LCD) from their Medicare carrier or intermediary that fill in gaps in the NCD.

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