CMS Pub. 100-08, ch. 10, § 10.2.2.6

MSCs are a certified supplier type that enroll via the Form CMS-855B.

A. General Background Information

As defined in 42 CFR § 410.34(a)(2), a screening mammography is a radiologic procedure

“furnished to a woman without signs or symptoms of breast disease for the purpose of early

detection of breast cancer, and includes a physician's interpretation of the results of the

procedure.” Section 410.34(a)(4) defines a “supplier of screening mammography” as a

“facility that is certified and responsible for ensuring that all screening mammography

services furnished to Medicare beneficiaries meet the conditions and limitations for

coverage of screening mammography services as specified in § 410.34(c) and (d).”

B. Enrollment of MSCs

Consistent with § 410.34(a)(7), in order to qualify for coverage of its services under the

Medicare program (and to thus enroll in Medicare), an MSC supplier must meet the

following requirements:

1. Must have a valid provisional certificate, or a valid certificate, that has been issued by

the Food and Drug Administration (FDA) indicating that the supplier meets the

certification requirements of section 354 of the PHS Act, as implemented by 21 CFR

part 900, subpart B.

2. Has not been issued a written notification by the FDA that states that the supplier must

cease conducting mammography examinations because the supplier is not in

compliance with certain critical certification requirements of section 354 of the PHS

Act, implemented by 21 CFR part 900, subpart B.

3. Must not employ for provision of the professional component of mammography

services a physician or physicians for whom the facility has received written

notification by the FDA that the physician (or physicians) is (or are) in violation of the

certification requirements set forth in section 354 of the PHS Act, as implemented by

21 CFR 900.12(a)(1)(i).

(The FDA is responsible for collecting certificate fees and surveying mammography

facilities (screening and diagnostic).)

Unless stated otherwise in this chapter or in another CMS directive, the MSC shall submit a

copy of its FDA certificate with its application. If the supplier fails to submit the FDA

certificate within 30 days of the MAC’s request, the MAC shall reject the application

consistent with section 10.4(H)(2) of this chapter.

It is important that the contractor review and adhere to the following regulations and

instructions regarding the required qualifications of MSCs:

• 42 CFR § 410.34

• Pub. 100-04, chapter 18, sections 20 through 20.1.2

• Pub. 100-02, chapter 15, section 280.3