Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20

Forms and Documents

Document	Type	Status	Availability
CMS-10225.REVISED-Supporting Statement-7 23 08.doc	Supporting Statement A	Uploaded 2008-09-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
186814	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (No Physician Owners)		New
186813	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Physician Disclosure)		New
186812	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Medical Staff)		New
186811	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Hospital Disclosure)		New
182130	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 489.20 (Outpatient)		Modified
182129	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Inpatient)		Modified
182128	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Attorney)		Modified
182127	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Outpatient)		Modified
182126	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Inpatient)		Modified
182125	Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Attorney)		Modified

ICR Details

OMB Control No: 0938-1034	ICR Reference No: 200810-0938-005
Status: Historical Active	Previous ICR Reference No: 200709-0938-007
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: 12/19/2008
	Date Received in OIRA: 10/03/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	02/28/2011
Responses	49,735,848	0	49,735,635
Time Burden (Hours)	840,319	0	839,599
Cost Burden (Dollars)	0	0	0

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Abstract: The intent of the proposed disclosures is to increase the transparency of the hospital's ownership and operations to patients as they make decisions about receiving care at the hospital. We have revised 489.20(u) by creating 489.20(u)(1) that would require that the list of physician owners or investors (including immediate family members) be furnished at the time the patient or someone on the patient's behalf requests it. We have also added new 489.20(u)(2) to require a hospital to require all physician 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 they refer to the hospital any ownership or investment interest in the hospital held by themselves or by an immediate family member. We also have included under 489.20(v) new language to provide for an exception to the disclosure requirements for a physician-owned hospital that does not have any physician owners who refer patients to the hospital (and that has no referring physicians who have an immediate family member with an ownership or investment interest in the hospital), provided that the hospital attests, in writing, to that effect and maintains such attestation in its files. In CMS 1390-P, we have redesignated existing 489.20(v) and (w) as 489.20(w) and (x), respectively, to accommodate the addition of the exception to the requirements in 489.20(v) as discussed below. The new burden is limited to the provisions proposed in 489.20(u)(2) and (v).

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Authorizing Statute(s): PL: Pub.L. 109 - 171 5006(a)(1) Name of Law: Deficit Reduction Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AP15	Final or interim final rulemaking	73 FR 48434	08/19/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 23528	04/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 46301	08/08/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Attorney)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Inpatient)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Outpatient)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Hospital Disclosure)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Medical Staff)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Physician Disclosure)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Attorney)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Inpatient)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 489.20 (Outpatient)
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (No Physician Owners)

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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	49,735,848	49,735,635	0	213	0	0
Annual Time Burden (Hours)	840,319	839,599	0	720	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: We are revising the burden to accomodate the new information collection requirements as stated in CMS-1390-F.

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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

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Common Form ICR:  No

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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: 10/03/2008

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