CMS Pub. 100-02, ch. 11, § 20.4.2

Effective January 1, 2021, the eligibility criteria for TPNIES require that the equipment or supply:

1. Has been designated by CMS as a renal dialysis service under § 413.171;

2. Is new, meaning a complete application has been submitted to CMS within 3 years of the date of the

FDA marketing authorization;

3. Is commercially available by January 1 of the particular calendar year, meaning the year in which

the payment adjustment would take effect;

4. Has a Healthcare Common Procedure Coding System (HCPCS) Level II code application submitted,

in accordance with the HCPCS Level II coding procedures on the CMS website, by the HCPCS Level

II code application deadline for biannual Coding Cycle II for non-drug and non-biological items,

supplies, and services as specified in the HPCPCS Level II coding guidance on the CMS website

prior to the particular calendar year. HCPCS coding procedures and deadlines are available on the

CMS website:

https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSCODINGPROCESS;

5. Is innovative, meaning it meets the criteria specified in § 412.87(b)(1).

An equipment or supply is considered innovative if it represents an advance that substantially

improves, relative to technologies previously available, the diagnosis or treatment of Medicare

beneficiaries (i.e., it offers a “Substantial Clinical Improvement” over existing technologies).

6. Is not a capital-related asset, except for capital-related assets that are home dialysis machines.

Note: In the CY 2021 ESRD PPS final rule CMS finalized an exception for capital related assets which are

home dialysis machines when used in the home for a single patient (see §20.4.3 of this chapter for more

information)

CMS uses the following parameters to evaluate Substantial Clinical Improvement for purposes of the

TPNIES (see 42 CFR § § 413.236(b)(5) and 412.87(b)(1)):

(i) The totality of the circumstances is considered when making a determination that a new renal

dialysis equipment or supply represents an advance that substantially improves, relative to renal

dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries.

(ii) A determination that a new renal dialysis equipment or supply represents an advance that

substantially improves, relative to renal dialysis services previously available, the diagnosis or

treatment of Medicare beneficiaries means one of the following:

(A) The new renal dialysis equipment or supply offers a treatment option for a patient population

unresponsive to, or ineligible for, currently available treatments.

(B) The new renal dialysis equipment or supply offers the ability to diagnose a medical condition in

a patient population where that medical condition is currently undetectable, or offers the ability to

diagnose a medical condition earlier in a patient population than allowed by currently available

methods and there must also be evidence that use of the new renal dialysis service to make a

diagnosis affects the management of the patient.

(C) The use of the new renal dialysis equipment or supply significantly improves clinical outcomes

relative to renal dialysis services previously available as demonstrated by one or more of the

outcomes described below.

(1) A reduction in at least one clinically significant adverse event, including a reduction in mortality

or a clinically significant complication.

(2) A decreased rate of at least one subsequent diagnostic or therapeutic intervention.

(3) A decreased number of future hospitalizations or physician visits.

(4) A more rapid beneficial resolution of the disease process treatment including, but not limited to,

a reduced length of stay or recovery time.

(5) An improvement in one or more activities of daily living.

(6) An improved quality of life.

(7) A demonstrated greater medication adherence or compliance.

(D) The totality of the circumstances otherwise demonstrates that the new renal dialysis equipment

or supply substantially improves, relative to renal dialysis services previously available, the

diagnosis or treatment of Medicare beneficiaries.

(iii) Evidence from published or unpublished information sources from within the United States or

elsewhere may be sufficient to establish that a new renal dialysis equipment or supply represents an

advance that substantially improves, relative to renal dialysis services previously available, the

diagnosis or treatment of Medicare beneficiaries. Information source may include the following:

(A) Clinical trials;

(B) Peer reviewed journal articles;

(C) Study results;

(D) Meta-analyses;

(E) Consensus statements;

(F) White papers;

(G) Patient surveys;

(H) Case studies;

(I) Reports;

(J) Systematic literature reviews;

(K) Letters from major healthcare associations;

(L) Editorials and letters to the editor; and,

(M) Public comments.

(N) Other appropriate information sources may be considered.

(iv) The medical condition diagnosed or treated by the new renal dialysis equipment or supply may

have a low prevalence among Medicare beneficiaries.

(v) The new renal dialysis equipment or supply may represent an advance that substantially

improves, relative to renal dialysis services previously available, the diagnosis or treatment of a

subpopulation of patients with the medical condition diagnosed or treated by the new renal dialysis

equipment or supply; and