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

ICR 201008-0938-011

OMB: 0938-1034

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-08-18
ICR Details
0938-1034 201008-0938-011
Historical Inactive 200810-0938-005
HHS/CMS
Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20
Revision of a currently approved collection   No
Regular
Comment filed on proposed rule and continue 10/04/2010
Retrieve Notice of Action (NOA) 08/19/2010
OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved 12/31/2011
49,735,848 0 49,735,848
840,319 0 840,319
0 0 0

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.

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

0938-AP82 Proposed rulemaking 75 FR 46170 08/10/2010

Yes

No
No
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.

$0
No
No
Yes
Uncollected
No
Uncollected
William Parham 4107864669

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/19/2010


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