CMS Pub. 100-03, ch. 1, § 210.11

November 8, 2011)

(Rev. 137, Issued: 11-23-11, Effective: 11-08-11, Implementation: 12-27-11 non-shared system edits, 04-02-12 shared system edits, 07-02-12 CWF/HICR/MCS MCDST)

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.)