NCD 210.11: Intensive Behavioral Therapy for Cardiovascular Disease

A. General

Cardiovascular disease (CVD) is the leading cause of mortality in the United States. CVD, which is comprised of hypertension, coronary heart disease (such as myocardial infarction and angina pectoris), heart failure and stroke, is also the leading cause of hospitalizations. Although the overall adjusted mortality rate from heart disease has declined over the past decade, opportunities for improvement still exist. Risk factors for CVD include being overweight, obesity, physical inactivity, diabetes, cigarette smoking, high blood pressure, high blood cholesterol, family history of myocardial infarction, and older age.

Under §1861(ddd) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of additional preventive services through the National Coverage Determination (NCD) process if certain statutory requirements are met. Following its review, CMS has determined that the evidence is adequate to conclude that intensive behavioral therapy for CVD is reasonable and necessary for the prevention or early detection of illness or disability, is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, and is comprised of components that are recommended with a grade of A or B by the U.S. Preventive Services Task Force (USPSTF).

B. Nationally Covered Indications

Effective for claims with dates of service on or after November 8, 2011, CMS covers intensive behavioral therapy for CVD (referred to below as a CVD risk reduction visit), which consists of the following three components:

• encouraging aspirin use for the primary prevention of CVD when the benefits outweigh the risks for men age 45-79 years and women 55-79 years;

• screening for high blood pressure in adults age 18 years and older; and

• intensive behavioral counseling to promote a healthy diet for adults with hyperlipidemia, hypertension, advancing age, and other known risk factors for cardiovascular- and diet-related chronic disease.

We note that only a small proportion (about 4%) of the Medicare population is under 45 years (men) or 55 years (women), therefore the vast majority of beneficiaries should receive all three components. Intensive behavioral counseling to promote a healthy diet is broadly recommended to cover close to 100% of the population due to the prevalence of known risk factors.

Therefore, CMS covers one, face-to-face CVD risk reduction visit per year for Medicare beneficiaries who are competent and alert at the time that counseling is provided, and whose counseling is furnished by a qualified primary care physician or other primary care practitioner in a primary care setting.

The behavioral counseling intervention for aspirin use and healthy diet should be consistent with the Five As approach that has been adopted by the USPSTF to describe such services:

• Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods.

• Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits.

• Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior.

• Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate.

• Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.

For the purpose of this NCD, a primary care setting is defined as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, and hospices are not considered primary care settings under this definition.

For the purpose of this NCD, a “primary care physician” and “primary care practitioner” are defined consistent with existing sections of the Act (§1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)).

§1833(u)

(6) Physician Defined.—For purposes of this paragraph, the term “physician” means a physician described in section 1861(r)(1) and the term “primary care physician” means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist.

§1833(x)(2)

(A) Primary care practitioner.—The term “primary care practitioner” means an individual—

(i) who—

(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or

(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)).

C. Nationally Non-Covered Indications

Unless specifically covered in this NCD, any other NCD, or in statute, preventive services are non-covered by Medicare.

D. Other

Medicare coinsurance and Part B deductible are waived for this preventive service.

(This NCD last reviewed November 2011.)

11/2011 - Effective for claims with dates of service on and after November 8, 2011, CMS covers intensive behavioral therapy for cardiovascular disease, inclusive of one face-to-face risk reduction visit annually.

This revision [to the Medicare National Coverage Determinations Manual] is a national coverage determination (NCD). NCDs are binding on all carriers, fiscal intermediaries,[contractors with the Federal government that review and/or adjudicate claims, determinations, and/or decisions], quality improvement organizations, qualified independent contractors, the Medicare appeals council, and administrative law judges (ALJs) (see 42 CFR section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD. (See section 1869(f)(1)(A)(i) of the Social Security Act.) Effective date 10/14/2011. Implementation date 12/27/2011. ( TN 137 ) (CR7636)