Disclosures Required Regarding Physician Ownership and On-site Availability of an MD/DO (CMS-10225)

Forms and Documents

Document	Type	Status	Availability
CMS-10225 Final Supporting Statement .02.21.18.docx	Supporting Statement A	Uploaded 2018-02-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
195712	42 CFR 489.20(u)(1) - Disclosure of Physician Owners/Investors to Patients		Removed
195711	42 CFR 411.362(b)(3)(ii)(C) Website/Public Advertising Disclosure		Modified
186813	42 CFR 489.20(w)(1)- (5)- Disclosure of Physician Owners/Investors to Staff Physicians		Modified
186812	42 CFR 411.362(b)(3)(ii)(A) and 489.20(u)(2) - Medical Staff by-Laws and Policies (Attorney)		Modified
186811	42 CFR 489.20(u)(1) - Attestation of non-Referring Status (Attorney)		Modified
182130	42 CFR 411.362(b)(5)(i) - Disclosures		Modified
182129	42 CFR 489.20(u)(1) - (5) - Disclosure of physician owners/investors		Modified
182127	42 CFR 489.20(u)(1) - Outpatient Disclosure		Modified
182126	42 CFR 489.20(u)(1) - Inpatient Disclosure		Modified
182125	42 CFR 489.20(u)(1) - Create Disclosure		Modified

ICR Details

OMB Control No: 0938-1034	ICR Reference No: 201707-0938-011
Status: Active	Previous ICR Reference No: 201403-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No: 21556
Title: Disclosures Required Regarding Physician Ownership and On-site Availability of an MD/DO (CMS-10225)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/26/2018
	Date Received in OIRA: 07/25/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	02/28/2018
Responses	7,869,288	0	14,945,498
Time Burden (Hours)	181,505	0	333,583
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): 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
   PL: Pub.L. 109 - 171 5006(a)(1) Name of Law: Deficit Reduction Act
   US Code: 42 USC 1395i-4(c) Name of Law: Medicare Ruaral Hospital Flexibility Program Described
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 21817	05/10/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32708	07/17/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
42 CFR 489.20(u)(1) - Create Disclosure
42 CFR 489.20(u)(1) - Inpatient Disclosure
42 CFR 489.20(u)(1) - Outpatient Disclosure
42 CFR 489.20(u)(1) - (5) - Disclosure of physician owners/investors
42 CFR 411.362(b)(5)(i) - Disclosures
42 CFR 489.20(u)(1) - Disclosure of Physician Owners/Investors to Patients
42 CFR 489.20(u)(1) - Attestation of non-Referring Status (Attorney)
42 CFR 411.362(b)(3)(ii)(A) and 489.20(u)(2) - Medical Staff by-Laws and Policies (Attorney)
42 CFR 489.20(w)(1)- (5)- Disclosure of Physician Owners/Investors to Staff Physicians
42 CFR 411.362(b)(3)(ii)(C) Website/Public Advertising Disclosure

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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	7,869,288	14,945,498	0	-284	-7,075,926	0
Annual Time Burden (Hours)	181,505	333,583	0	-303	-151,775	0
Annual Cost Burden (Dollars)	0	0	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 changes in the number of physician owned hospitals and CAHs from the previous package which was 265 compared to the current number of 81. Additionally, for CY 2016 there were changes in the number of inpatient and outpatient claims submitted to the MACs for payment from hospitals and CAHs. This current claim information was used to calculate burden associated with the estimated inpatients and outpatients that are required to receive disclosure notices. These changes decreased the estimated burden hours from 333,583 to 181,505.

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Annual Cost to Federal Government: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

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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: 07/25/2017

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