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