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

Forms and Documents

Document Name	Status
Supporting Statement A for CMS 10225. Clean Copy Version. 02.09.21.docx Supporting Statement A	2021-05-21

IC Document Collections

IC ID	Document Title	Status
247551	42 CFR 489.20(w)(4) Receive patient signature on written notice of lack of MD coverage	New
247550	42 CFR 489.20(w)(2) Distribution of Written Notice of Lack of Physician Coverage in Hospital	New
195711	42 CFR 411.362(b)(3)(ii)(C) Updating disclosure notice on hospital's public website	Modified
186813	42 CFR 489.20(w)(1)- (5)- Disclosure of Physician Owners/Investors to Staff Physicians	Removed
186812	42 CFR 411.362(b)(3)(ii)(A) and 489.20(u)(2) - Medical Staff by-Laws and Policies (Attorney)	Removed
186811	42 CFR 489.20(u)(1) - Attestation of non-Referring Status (Attorney)	Removed
182130	42 CFR 411.362(b)(5)(i) - Disclosures	Removed
182129	42 CFR 489.20(u)(1) Privide Physician List to Patients	Modified
182127	42 CFR 489.20(u)(1) - Outpatient Disclosure	Removed
182126	42 CFR 489.20(u)(1) - Providet Disclosure Form	Modified
182125	42 CFR 489.20(u)(1) - Develop Disclosure	Modified

ICR Details

OMB Control No: 0938-1034	ICR Reference No: 202105-0938-008
Status: Received in OIRA	Previous ICR Reference No: 201707-0938-011
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: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/21/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	4,675,114	0
Time Burden (Hours)	78,935	0
Cost Burden (Dollars)	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:
	86 FR 13566	03/09/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 27465	05/20/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
42 CFR 411.362(b)(3)(ii)(A) and 489.20(u)(2) - Medical Staff by-Laws and Policies (Attorney)
42 CFR 411.362(b)(3)(ii)(C) Updating disclosure notice on hospital's public website
42 CFR 411.362(b)(5)(i) - Disclosures
42 CFR 489.20(u)(1) Privide Physician List to Patients
42 CFR 489.20(u)(1) - Attestation of non-Referring Status (Attorney)
42 CFR 489.20(u)(1) - Develop Disclosure
42 CFR 489.20(u)(1) - Outpatient Disclosure
42 CFR 489.20(u)(1) - Providet Disclosure Form
42 CFR 489.20(w)(1)- (5)- Disclosure of Physician Owners/Investors to Staff Physicians
42 CFR 489.20(w)(2) Distribution of Written Notice of Lack of Physician Coverage in Hospital
42 CFR 489.20(w)(4) Receive patient signature on written notice of lack of MD coverage

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ICR Summary of Burden

	Total Request	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	4,675,114	0	0	-5,330,680	2,136,506	7,869,288
Annual Time Burden (Hours)	78,935	0	0	-139,038	36,468	181,505
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden hours decreased from 181,505 to 78,035. We believe that the writer of the previous PRA package used the incorrect metric for measuring the total number of annual responses, and therefore, used too high a number of responses. In the previous Supporting Statement A, it was estimated that there were approximately 15,882,402 hospital inpatient claims, and approximately 127,585,067 hospital outpatient surgical claims, which equated to a total of 143,467,469 claims across all hospital in 2016.

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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? No

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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: 05/21/2021

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