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Physician offices may provide both medical care and
diagnostic tests. However, diagnostic tests are a special and separate kind
of Medicare benefit under Section 1861(s)(3) of the Social Security Act
(SSA), which is amplified at 42 CFR 410.32 and 410.33. Much of the time,
these rules specific to diagnostic tests, do not impact physician office
practices. However, some key points do require compliance.
(1) Diagnostic Tests Are Not “Incident-to” Services
Many office services may be given “incident-to” the physician. For example,
the physician sees the patient and a nurse gives an antibiotic injection
“incident-to” the physician’s care. These services are typically billed “as
if” the physician provided them directly. Diagnostic tests may also be
billed appropriately “as if” the physician provided them directly. But
diagnostic tests are not “incident-to” tests, as explained in Sections 60
and 80 of the Program Benefit Manual, Chapter 15. Diagnostic clinical tests
are given under supervision levels described in Section 80 (usually
general, direct, or personal supervision). Supervision levels are published
by CMS in an online version of the physician fee schedule which is updated annually.
A physician assistant may not supervise diagnostic tests performed by
technicians under Medicare guidelines, regardless of State Law. (He may
order or perform such tests as necessary and appropriate.) Another special
characteristic of diagnostic tests is circumstances when they must be
billed through an IDTF. See section (2).
(2) Diagnostic Testing Centers May Be Required To Enroll As IDTFs
Medicare’s enrollment form for contractors (855B) contains clear guidance
as to when a diagnostic testing center must enroll as an IDTF. (This
guidance is also found in the Program Integrity Manual, Chapter 10, Section
5.1). Labs performing CLIA-related laboratory tests (on the laboratory fee
schedule) and pathology tests (on the physician fee schedule) are exempt
from enrolling as IDTFs. Radiologist-owned radiology centers are generally
exempt; see special guidance in the 855B form. However, experience in California has shown
that the remaining types of diagnostic tests are sometimes provided in a
manner for which the provider “must” enroll as an IDTF, according to
explicit CMS instructions. As described in the 855B enrollment form, an
entity can bill as a physician office, rather than an IDTF, only if it
meets the four following characteristics. Entities not meeting these four
characteristics “must” enroll as an IDTF, at least for the associated
diagnostic tests.
[Quotation from Form 855B]
i. It is a physician practice that is owned, directly or indirectly, by one
or more physicians or by a hospital;
ii. The entity primarily bills for physician services (e.g., evaluation and
management (E & M) codes) and not for diagnostic tests;
iii. It furnishes diagnostic tests primarily to patients whose medical
conditions are being treated or managed on an ongoing basis by one or more
physician in the practice;
iv. The diagnostic tests are performed and interpreted at the same location
where the practice physicians also treat patients for their medical
conditions.
However, if a substantial portion of the entity’s business involves the
performance of diagnostic tests, the diagnostic testing services may be a
sufficiently separate business to warrant enrollment as an IDTF (it is
considered independent for purposes of enrollment). In that case, the
physician or group can continue to be enrolled as a physician or a group
practice of physicians, but must also enroll as an IDTF. The
physician or group can bill for professional fees and the diagnostic tests
they perform on their patients using their billing number. However, the practice
must bill as an IDTF for diagnostic tests furnished to Medicare
beneficiaries who are not patients of the practice. The carrier should
advise the entity how to bill for physician office tests versus IDTF tests
and advise the claims personnel of the dual enrollment.
[End quotation from Form 855B. Emphasis added.]
(3) Ensure Your Current Enrollment Is Correct
If you enrolled as a physician office practice, the passage quoted above
described circumstances under which you “must also enroll as an IDTF”. For
example, the practice is no long “owned, directly or indirectly, by one or
more physicians”, the practice now bills little for therapeutic services
and mostly for diagnostic tests, or the patients are not treated or managed
by practice physicians. (A bona fide consultation is a form of management;
for example, bona fide “consulting physicians” as well as treating
physicians can order diagnostic tests under 42 CFR 410.32 and 410.33).
From time to time Medicare may review practice profiles and advise
physicians if the profile is characteristic of an IDTF rather than a
physician practice, as outlined in Form 855B. For example, NHIC has
identified practices enrolled as a physician office billing large volumes
of entirely unrelated diagnostic tests on patients who are not under
consultation from a referring physician and who are never seen again by the
clinic. In some of the same cases, these clinics have turned out to have
non-physician ownership. See point (4) below.
(4) Ensure Your Ownership Structure Is Correctly Represented On Your
855B Form And Update As Necessary
The 855B form contains sections regarding the ownership and the management
of the clinic, and explanatory text describing the use of those sections.
These sections should be updated if ownership and management changes. In
addition, while NHIC does not offer legal advice regarding California
Regulations, entities must provide all relevant business and professional
certificates or licenses with State Law, for example, Section 1200-1249 of the
California Health & Safety code.
REFERENCES
Social Security Act, Section 1861(s)(3)
42 CFR 410.32 (Diagnostic Tests)
42 CFR 410.33 (Independent Diagnostic Testing Facilities)
Benefit Policy Manual (Internet Only Manual, Pub. 100-02), Chapter 15 (Covered
Medical and Other Health Services), Sections 60 and 80
Program Integrity Manual (Internet Only Manual, Pub. 100-08), Chapter 10
(Enrollment), Section 5.1
Enrollment Form for Contractors (CMS Form 855B)
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