CMS-10654 - Supporting Statement A (rev 07-21-2017 by OSORA PRA)

Supporting Statement – Part A
Appropriate Use Criteria (AUC) for Diagnostic Imaging Services: Consultation of Specified
Applicable AUC through a Qualified Clinical Decision Support Mechanism (CDSM)
CMS-10654, OMB 0938-New
Background
The collection of information under the Appropriate Use Criteria (AUC) for Diagnostic Imaging
Services program for AUC consultations is an essential component of this program required
under sections 1834(q)(4)(A) and (B) of the Act (as amended by section 218(b) of the Protecting
Access to Medicare Act of 2014 (PAMA)).
For CMS to ensure that ordering professionals are consulting specified applicable AUC using a
qualified clinical decision support mechanism (CDSM), reporting professionals are including this
information on the Medicare claim form as required under section 1834(q)(4)(A) and (B) of the
Act. Therefore, we are proposing in the CY 2018 Physician Fee Schedule proposed rule (CMS1676-P) under §414.94(j) and §414.94(k) to require consultation and reporting to begin for
specified applicable imaging services furnished in an applicable setting, paid for under an
applicable payment system and ordered on and after January 1, 2019.
We are also proposing, consistent with section 1834(q)(4)(B) of the Act, that the reporting
professional include the following information on the Medicare claim: 1) which qualified CDSM
was consulted by the ordering professional; 2) whether the service ordered would adhere to
specified applicable AUC, whether the service ordered would not adhere to specified applicable
AUC, or whether the specified applicable AUC consulted was not applicable to the service
ordered; 3) the national provider identifier (NPI) of the ordering professional who consults
specified applicable AUC if different from the furnishing professional. The proposed reporting
requirement would not have any impact on any Medicare claim forms because the forms’ data
fields, instructions, and burden are not expected to require any changes. Consequently, this
collection of information request reflects the proposed consultation requirement and does not
include the reporting requirement.
Section 414.94(b) of the Act defines applicable imaging service as an advanced diagnostic
imaging service (as defined in section 1834(e)(1)(B) of the Act) for which the Secretary
determines 1) one or more applicable AUC apply; 2) there are one or more qualified CDSMs
listed; and 3) one or more of such mechanisms is available free of charge. This section defines
applicable setting as a physician’s office, a hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any other provider-led outpatient
setting determined appropriate by the Secretary. This section also defines applicable payment
system as the physician fee schedule established under section 1848(b) of the Act, the
prospective payment system for hospital outpatient department services under section 1833(t) of
the Act, and the ambulatory surgical center payment system under section 1833(i) of the Act.

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This information collection request should not be confused with our CMS-10570 (OMB 09381288) package (Appropriate Use Criteria for Advanced Diagnostic Imaging Services) which
pertains to the application process for provider-led entities (PLEs) or CMS-10624 (OMB 09381315) package (Appropriate Use Criteria (AUC) for Diagnostic Imaging Services: Clinical
Decision Support Mechanism (CDSM) Application Process) which pertains to the application
process for qualification of CDSMs.
As defined in §414.94(b), a provider-led entity (PLE) means a national professional medical
specialty society or other organization that is comprised primarily of providers or practitioners
who, either within the organization or outside of the organization, predominantly provide direct
patient care. To be qualified, PLEs must submit an application documenting adherence to the
requirements for developing or modifying AUC under §414.94(c)(1). The application process is
described in §414.94(c)(2). Some examples of qualified PLEs include the American College of
Cardiology Foundation, the American College of Radiology, and Intermountain Healthcare.
On the other hand, as defined in §414.94(b), a CDSM is an interactive, electronic tool for use by
clinicians that communicates AUC information to the user and assists them in making the most
appropriate treatment decision for a patient’s specific clinical condition. Tools may be modules
within or available through certified EHR technology or private sector mechanisms independent
from certified EHR technology or established by the Secretary. To be qualified, a CDSM
developer must submit an application documenting adherence to the requirements under
§414.94(g)(1). The application process is described in §414.94(g)(2). The first list of qualified
CDSMs will be available by June 30, 2017.
A. Justification
1.

Need and Legal Basis

Section 218(b) of the Protecting Access to Medicare Act of 2014 (PAMA) amended Title XVIII
of the Social Security Act to add section 1834(q) entitled, “Recognizing Appropriate Use Criteria
for Certain Imaging Services,” which CMS to establish a program to promote the use of AUC for
advanced diagnostic imaging services. This new program is available at 42 CFR 414.94.
Section 1834(q)(4)(A) of the Act as added by PAMA, specifies that ordering professionals
consult with a qualified decision support mechanism and provide to the furnishing professional
1) information about which qualified CDSM was consulted by the ordering professional for the
service; 2) information regarding whether the service ordered would adhere to the applicable
AUC specified, whether the service ordered would not adhere to such criteria, or whether such
criteria was not applicable to the service ordered; and 3) the NPI of the ordering professional (if
different from the furnishing professional).
Section 1834(q)(4)(B) of the Act as added by PAMA, specifies that furnishing professionals
must include on the Medicare claim the above information in order for payment to be made for
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applicable imaging services furnished in applicable settings and paid for under an applicable
payment system.
2.

Information Users

The information will be used by Medicare claims processing systems to determine payment for
advanced diagnostic imaging services. In the future, we expect the consultation information to
be used in the identification of outlier ordering professionals to apply prior authorization for
applicable imaging services that are ordered by such professionals. We expect details on this
component to be addressed in future rulemaking.
3.

Use of Information Technology

The collection of information regarding AUC consultation by the ordering professional is
performed and maintained by the CDSM consistent with requirements of qualification in
§414.94(g)(1)(x) and already involves the use of automated, electronic collection techniques.
This collection does not require a signature from the submitter, and 100% of responses will be
collected electronically. The basis of our decision for adopting this automated, electronic
collection technique results from both the identification of the most administratively efficient
manner to collect information and section 1834(q)(3)(B)(ii)(vii) of the Act to which the Secretary
may specify that the mechanism perform other such functions for the ordering professional.
Therefore, we believe that this means of collection is consistent with the Government Paperwork
Elimination Act (GPEA).
The reporting of information regarding AUC consultation by the furnishing professional is
performed on the relevant Medicare claim form and already involves the use of automated,
electronic collection techniques. Electronic data interchange is a technology alternative to the
submission of paper claim forms. All of the data collected by a paper claim form can also be
collected electronically, which further reduces costs and increases efficiency for providers and
suppliers. Legislation has also been enacted which mandates claims be submitted electronically
to Medicare. The Administrative Simplification Compliance Act amendment to section 1862(a)
of the Social Security Act prescribes that “no payment may be made under Part A or Part B of the
Medicare Program for any expenses incurred for items or services” for which a claim is received
in a non-electronic form. Consequently, absent an applicable exception, paper claims received
by Medicare will not be paid.
4.

Duplication of Efforts

There are no duplicative efforts to collect this specific consultation information.
5.

Small Businesses

There is no significant impact on small businesses to collect AUC consultation information as
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such information is performed and maintained by the CDSM consistent with requirements of
qualification in §414.94(g)(1)(x), already involves the use of automated, electronic collection
techniques, and Section 1834(q)(1)(C)(iii) of the Act requires that one or more of such
mechanisms is available free of charge. There is also no significant impact on small businesses
to report AUC consultation information as approximately 96.5% of small business submit
electronic claims forms to Medicare, leaving only a small percentage that submit via paper.
6.

Less Frequent Collection

In order for reimbursement to proceed in a timely and accurate manner, claims for reimbursement
should be submitted soon after the provision of service. Consequently, there is no coherent or
beneficial approach regarding the submitting of claims on a less frequent basis. Moreover,
extended delays in the processing of Part B claims would increase the probability of errors while
potentially imposing cash flow problems on physicians/suppliers as well as beneficiaries.
7.

Special Circumstances

Ordering professionals consult specified applicable AUC and furnishing professionals report
AUC consultation information with the submission of claim forms “on occasion.” In most
circumstances, this is more often than quarterly. Submission of claim forms is necessary for
reimbursement.
Otherwise, there are no special circumstances that would require an information collection to be
conducted in a manner that requires respondents to:
• Prepare a written response to a collection of information in fewer than 30 days after receipt
of it;
•

Submit more than an original and two copies of any document;

• Retain records, other than health, medical, government contract, grant-in-aid, or tax records
for more than three years;
• Collect data in connection with a statistical survey that is not designed to produce valid and
reliable results that can be generalized to the universe of study,
•

Use a statistical data classification that has not been reviewed and approved by OMB;

• Include a pledge of confidentiality that is not supported by authority established in statute or
regulation that is not supported by disclosure and data security policies that are consistent with
the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible
confidential use; or
• Submit proprietary trade secret, or other confidential information unless the agency can
demonstrate that it has instituted procedures to protect the information's confidentiality to the
extent permitted by law.

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8.

Federal Register/Outside Consultation

Federal Register
The CY 2018 Physician Fee Schedule proposed rule (CMS-1676-P, RIN 0938-AT02) published
in the Federal Register on July 21, 2017 (82 FR 33950) and is serving as the 60-day notice. The
notice filed for public inspection on July 13, 2017. Comments are due September 11, 2017.
Outside Consultation
We have engaged governmental and nongovernmental stakeholders in discussions regarding the
AUC program in general.
9.

Payments/Gifts to Respondents

While furnishing professionals will not be provided payment or gifts for this collection of
information, such information would be necessary for payment of applicable imaging services
furnished under these proposals.
10. Confidentiality
The AUC information provided on Medicare claim forms is protected and held confidential in
accordance with 20 CFR 401.3. The information provided on these forms will become part of
the Medicare contractors’ computer history, microfilm, and hard copy records’ retention system
as published in the Federal Register, Part VI, “Privacy Act of 1974 System of Records,” on
September 20, 1976 (HI CAR 0175.04).
ROUTINE USE(S): Information from claims and related documents may be given to the
Department of Veterans Affairs, the Department of Health and Human Services and/or the
Department of Transportation consistent with their statutory administrative responsibilities
under TRICARE/CHAMPVA; to the Department of Justice for representation of the Secretary of
Defense in civil actions; to the Internal Revenue Service, private collection agencies, and
consumer reporting agencies in connection with recoupment claims; and to Congressional
Offices in response to inquiries made at the request of the person to whom a record pertains.
Appropriate disclosures may be made to other federal, state, local, foreign government agencies,
private business entities, and individual providers of care, on matters relating to entitlement,
claims adjudication, fraud, program abuse, utilization review, quality assurance, peer review,
program integrity, third-party liability, coordination of benefits, and civil and criminal litigation
related to the operation of TRICARE.
11. Sensitive Questions
There are no sensitive questions associated with this collection. Specifically, the collection does
not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs,
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and other matters that are commonly considered private.
12. Burden Estimates (Hours & Wages)
In order for CMS to ensure ordering professionals are consulting specified applicable AUC using
a qualified clinical decision support mechanism (CDSM), reporting professionals are including
this information on the Medicare claim form as required under section 1834(q)(4)(A) and (B) of
the Act. Therefore, we are proposing under §414.94(j) and §414.94(k) to require consultation
and reporting to begin for specified applicable imaging services furnished in an applicable
setting, paid for under an applicable payment system and ordered on and after January 1, 2019.
We are also proposing, consistent with section 1834(q)(4)(B) of the Act, that AUC consultation
information includes all of the following: 1) which qualified CDSM was consulted by the
ordering professional; 2) whether the applicable imaging service ordered would adhere to
specified applicable AUC, whether the applicable imaging service ordered would not adhere to
specified applicable AUC, or whether the specified applicable AUC consulted was not applicable
to the applicable imaging service ordered; 3) the NPI of the ordering professional who consults
specified applicable AUC if different from the furnishing professional.
12.1 Wage Estimates
To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2016
National Occupational Employment and Wage Estimates for all salary estimates
(http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the
mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the
adjusted hourly wage.
National Occupational Employment and Wage Estimates
Occupation Title
Occupation Mean Hourly
Fringe Benefit
Adjusted Hourly
Code
Wage ($/hr)
($/hr)
Wage ($/hr)
Family and general 29-1062
96.54
96.54
193.08
practitioner

As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent.
This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary
significantly from employer to employer, and because methods of estimating these costs vary
widely from study to study. Nonetheless, there is no practical alternative and we believe that
doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
12.2 Information Collection Requirements and Burden Estimates
The one-time burden associated with the requirements under §414.94(j) is the time and effort it
will take each ordering professional to consult specified applicable AUC through a qualified
CDSM. During the proposed six month voluntary participation period, we estimate 3,410,000
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respondents in the form of consultations based on market research from current applicants for
qualification of their clinical decision support mechanisms for advanced diagnostic imaging
services. This estimate is based on feedback from CDSMs with experience in AUC consultation
as well as standards recommended by the Office of the National Coordinator (ONC) and the
Healthcare Information Management Systems Society (HIMSS).
We estimate it would take 2 minutes at $193.08/hr for a family and general practitioner to use a
qualified CDSM to consult specified applicable AUC. Per consultation, we estimate 2 minutes
(0.033 hr) at a cost of $6.37 (0.033 hr x $193.08/hr). In aggregate, we estimate a one-time
burden of 112,530 hours (0.033 hr x 3,410,000 consultations) at a cost of $21,727,292.40
(112,530 hr x $193.08/hr). Annually, we estimate 37,510 hours (112,530 hr/3 yr) at a cost of
$7,242,430.80 ($21,727,292.40/3 yr). We are annualizing the one-time burden (by dividing our
estimates by OMB’s 3-year approval period) since we do not anticipate any additional burden
after the six month voluntary participation period ends.
We estimate that beginning January 1, 2019, the number of respondents would increase to
43,181,818 based on 2014 Medicare claims data for advanced diagnostic imaging services. As
noted above, we estimate it would take 2 minutes (0.033 hr) at $193.08/hr for a family and
general practitioner to use a qualified CDSM to consult specified applicable AUC. In this regard,
we estimate 0.033 hours per consultation at a cost of $6.37 (0.033 hr x $193.08/hr). In aggregate,
we estimate an annual burden of 1,425,000 hours (0.033 hr x 43,181,818 consultations) at a cost
of $275,139,000 (1,425,000 hr x $193.08/hr).
The proposed voluntary and mandatory reporting requirements under §414.94(k) would not have
any impact on any Medicare claim forms because the forms’ currently approved data fields,
instructions, and burden are not expected to change as a result of the proposed provisions.
12.3 Summary of Annual Burden Estimates

Regulation
Section(s)
§414.94(j)
(voluntary
consultations)
§414.94(j)
(mandatory
consultations)
Total

OMB
Control
Number
0938-New

--

Burden per
Response
(hours)
0.033

Total
Annual
Burden
(hours)
37,510

Labor
Cost of
Reporting
($/hr)
193.08

Total Cost
($)*
7,242,431

Respondents
3,410,000

Responses
1,136,666.67
(3,410,000/3)

43,181,818

43,181,818

0.033

1,425,000

193.08

275,139,000

46,591,818

44,318,485

0.033

1,462,510

193.08

282,381,431

12.4 Collection of Information Instruments and Instruction/Guidance Documents
Not applicable.
13. Capital Costs
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We do not estimate there would be any capital costs associated with generating, maintaining, and
disclosing or providing AUC consultation information by the ordering professional. Consistent
with section 1834(q)(1)(C)(iii) of the Act and regulations at §414.94(b) one or more qualified
CDSMs is available free of charge.
We do not estimate there would be any capital costs associated with the reporting of information
regarding AUC consultation by the furnishing professional. Legislation, specifically The
Administrative Simplification Compliance Act amendment to section 1862(a) of the Social
Security Act, prescribes that “no payment may be made under Part A or Part B of the Medicare
Program for any expenses incurred for items or services” for which a claim is received in a nonelectronic form. Consequently, absent an applicable exception, paper claims received by
Medicare will not be paid. Therefore, we estimate that capital costs associated with reporting
AUC consultation information by the furnishing professional has already occurred to achieve
regulatory compliance with requirements not associated with this information collection, for
reasons other than to provide this information, and as part of customary and usual business
practices.
14. Cost to Federal Government
Based on FY 2010 figures, the administrative cost to the Federal Government to administer
Medicare Part B was $3,514,000,000 or 1.3 percent of benefit payments. 1 On the average, the
unit cost incurred to the Federal Government per claim was $0.38 2 in FY 2008. This figure
includes the direct costs and overhead cost for claims payment, reviews and hearings, and
beneficiary/physician inquiry lines.
15. Changes to Burden
There are no changes to burden, this is a new collection.
16. Publication/Tabulation Dates
The reported consultation information will not be published by CMS.
17. Expiration Date
The expiration date will be displayed on the AUC website:
18. Certification Statement
There are no exceptions to the certification statement.
1 Source: 2011 CMS Statistics, Table V.1.
2 Source: 2009 CMS Statistics, Table V.5. (Data not available in 2011 CMS Statistics Table V.5)

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