Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)

Forms and Documents

Document Name	Status
CMS-10207.Emergency Justification.REVISED-8-2-06.doc Supplementary Document	2006-09-18
CMS-10207.Supporting Statement-7-18-06.doc Supporting Statement A	2006-09-18

IC Document Collections

IC ID	Document Title	Status
45541	Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)	New
45540	Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)	New
45539	Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)	New
45538	Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)	New

ICR Details

OMB Control No: 0938-1009	ICR Reference No: 200610-0938-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 10/13/2006
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/05/2007
	Date Received in OIRA: 10/04/2006
Terms of Clearance: Upon resubmission, CMS will update the burden and number of respondents to reflect physician usage of electronic health information technology.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2007	6 Months From Approved
Responses	49,402	0	0
Time Burden (Hours)	13,393	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: As required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Improvement Act of 2003, this final rule creates an exception to the physician self-referral prohibition for certain arrangements in which a physician receives non-monetary remuneration in the form of items or services that is necessary and used solely to receive and transmit electronic prescription information. Also, this rule creates a regulatory exception for certain arrangements involving the provision of non-monetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, and receive electronic health records.

Emergency Justfication: Please see the attached emergency justification file.

---

Authorizing Statute(s): PL: Pub.L. 109 - 171 101 Name of Law: Deficit Reduction Act of 2005
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AN69	Final or interim final rulemaking	71 FR 45140	08/08/2006

---

Federal Register Notices & Comments
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 45569	08/09/2006
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)
Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)
Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)
Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F)

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	49,402	0	0	49,402	0	0
Annual Time Burden (Hours)	13,393	0	0	13,393	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/22/2006

---