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
We are adjusting our burden estimate to reflect the revisions to 489.20(w) made in the CY 2012 Outpatient Prospective Payment System final rule. As stated above, many hospitals experienced a reduced reporting burden as a result of the revisions to 489.20(w). The burden associated with this requirement was previously estimated to be 1,196,932.6 hours and $18,518,082. Under revised 489.20(w), the burden is estimated to be 127,644 hours and $2,551,148.
In addition, we are adjusting our burden estimates associated with 489.20(u), 411.362(b)(5)(i), and 411.362(b)(3)(ii)(C), because we believe (1) that in-house counsel will have already developed and reviewed the content of the disclosures concerning physician-ownership and whether there is a 24/7 on-site physician; (2) that approximately 90 percent of affected hospitals will have already revised their medical staff bylaws and policies requiring all physicians 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 who they refer to the hospital any physician (including immediate family member) ownership or investment interest in the hospital; and (3) that the majority of affected hospitals will have already developed and placed information on their respective websites and/or in public advertisements that they are owned or invested in by physicians. The burden previously estimated for the relevant portion of these regulations was 12,215.5 hours and $170,369.82 (please note that these numbers are only a subset of the entire burden estimate that was previously approved for these regulations). The burden for the revised portion of these regulations is 291.5 hours and $11,859.55 (again, these numbers are only a subset of the total burden estimate associated with these regulations).
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.
CMS-10225 - Supporting Statement A [rev 3-11-14 by OSORA PRA].docx
42 CFR 489.20(u)(1) - Disclosure of Physician Owners/Investors to Patients