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OMB Control No: 0938-1034	ICR Reference No: 201012-0938-010
Status: Historical Active	Previous ICR Reference No: 200810-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
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: 03/14/2011
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/15/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2014	36 Months From Approved	12/31/2011
Responses	52,391,536	0	49,735,848
Time Burden (Hours)	1,281,469	0	840,319
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. 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
   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.

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6001 Name of Law: Limitation on Medicare Exception to the Prohibition on Certain Physician Referrals for Hospitals.

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AP82	Final or interim final rulemaking	73 FR 71800	11/24/2010

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 48432	08/19/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 71800	11/24/2010
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Adjustment in Estimate
Annual Number of Responses	52,391,536	49,735,848	795	2,654,893
Annual Time Burden (Hours)	1,281,469	840,319	412,894	28,256
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: No

Burden Reduction Due to:

Short Statement: 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. The new disclosure requirements set forth in section 6001(a) of the ACA are: 1) A hospital must disclose on any public website for the hospital or in any public advertising that it is owned or invested in by physicians. Hospitals will be required to develop and place this information on their websites and/or in public advertisements and update such information as needed. 2) A hospital must have procedures in place to require that any referring physician owner/investor in the hospital, as part of his or her continued medical staff membership or admitting privileges, disclose to the patient being referred to the hospital any ownership/investment interest by the patient's treating physician(s). Hospital legal staff will be required to develop, draft and implement changes to the hospital's medical staff bylaws and policies governing admitting privileges, and hospitals will be required to provide a list of physician owners/investors to all of their staff physicians. Referring physicians, in turn, will be required to take the hospital-provided list of physician owners/investors and develop a notice to patients stating that if the patient is treated by any of the physicians on the list, such physician has a financial relationship with the hospital and the patient may want to evaluate whether to receive care from the hospital. 3)Following a hospital's disclosure to a patient that it does not have a physician available during all hours that the hospital is providing services to such patient (a current requirement under our regulations), the hospital must obtain a signed acknowledgment from the patient stating that the patient understands that no physician is available for that period. All hospitals (not just physican-owned hospitals) will be required to add an acknowledgment line to their existing disclosure forms, obtain the required signature from the patient, and include a copy of the notice in the patient's medical record.

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: William Parham 4107864669

View ICR - OIRA Conclusion