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OMB Control No: 0938-1034	ICR Reference No: 201403-0938-005
Status: Historical Active	Previous ICR Reference No: 201012-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: 21556
Title: Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/03/2014
	Date Received in OIRA: 03/12/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	14,945,498	0	52,391,536
Time Burden (Hours)	333,583	0	1,281,469
Cost Burden (Dollars)	0	0	0

Abstract: Section 6001(a) of the Patient Protection and Affordable Care Act (the ACA) amended section 1877(d)(2) and (d)(3) of the Act to impose additional restrictions in order to qualify for the rural provider and whole hospital exceptions under the physician self-referral law. Among those restrictions were provisions requiring hospitals to prevent conflicts of interest by disclosing physician ownership or investment interest to patients and also requiring hospitals to take certain steps to ensure patient safety.

Authorizing Statute(s): PL: Pub.L. 109 - 171 5006(a)(1) Name of Law: Deficit Reduction Act
   PL: Pub.L. 106 - 224 5006 Name of Law: Development of Strategic Plan Regarding Physician Investment in Specialty Hospitals.
   PL: Pub.L. 111 - 148 6001 Name of Law: Limitation on Medicare Exception to the Prohibition on Certain Physician Referrals for Hospitals.
   US Code: 42 USC 1395x(e) Name of Law: definition of the term "Hospital"
   US Code: 42 USC 1395i-4(c) Name of Law: Medicare Ruaral Hospital Flexibility Program Described

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 75925	12/13/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 13305	03/10/2014
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	14,945,498	52,391,536	-2,583	-37,443,455
Annual Time Burden (Hours)	333,583	1,281,469	-10,254	-937,632
Annual Cost Burden (Dollars)	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We are adjusting our burden estimate to reflect the revisions to 489.20(w) made in the CY 2012 Outpatient Prospective Payment System final rule. As stated above, many hospitals experienced a reduced reporting burden as a result of the revisions to 489.20(w). The burden associated with this requirement was previously estimated to be 1,196,932.6 hours and $18,518,082. Under revised 489.20(w), the burden is estimated to be 127,644 hours and $2,551,148. In addition, we are adjusting our burden estimates associated with 489.20(u), 411.362(b)(5)(i), and 411.362(b)(3)(ii)(C), because we believe (1) that in-house counsel will have already developed and reviewed the content of the disclosures concerning physician-ownership and whether there is a 24/7 on-site physician; (2) that approximately 90 percent of affected hospitals will have already revised their medical staff bylaws and policies requiring all physicians who are members of the hospital's medical staff to agree, as a condition of continued medical staff membership or admitting privileges, to disclose in writing, to all patients who they refer to the hospital any physician (including immediate family member) ownership or investment interest in the hospital; and (3) that the majority of affected hospitals will have already developed and placed information on their respective websites and/or in public advertisements that they are owned or invested in by physicians. The burden previously estimated for the relevant portion of these regulations was 12,215.5 hours and $170,369.82 (please note that these numbers are only a subset of the entire burden estimate that was previously approved for these regulations). The burden for the revised portion of these regulations is 291.5 hours and $11,859.55 (again, these numbers are only a subset of the total burden estimate associated with these regulations).

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]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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