Section 4401 of the Omnibus Budget
Reconciliation Act of 1990 and section 1927(d) of the Social
Security Act requires States to provide for a Medicaid Drug
Utilization Review (DUR) program for covered outpatient drugs. The
DUR program is required to assure that prescriptions are
appropriate, medically necessary and are not likely to result in
adverse medical results. Each State DUR program must consist of
prospective drug use review, retrospective drug use review, data
assessment of drug use against predetermined standards, and ongoing
educational outreach activities. In addition, States are required
to submit an annual DUR program report that includes a description
of the nature and scope of State DUR activities as outlined in the
statute and regulations. The Centers for Medicare and Medicaid
Services, Center for Medicaid, CHIP and Survey and Certification,
is requesting a 3-year approval of the State data collection
requirements, the CMS forms CMS-R-153, CMS-R-153a, CMS-R-153b, and
CMS-R-153c data collection instruments with instructions and the
annual reporting contained in the Medicaid Drug Utilization Review
regulation.
PL:
Pub.L. 101 - 508 4401 Name of Law: Reimbursement for prescribed
drugs
US Code: 42
USC 1396r-8 Name of Law: Payment for Covered Outpatient
Drugs
The survey instrument is being
revised to address how states are monitoring clinical practices in
the profession and to address innovations going forward in the
health care arena. We removed request for data elements that were
not considered to be useful any longer such as some demographic
information, questions about therapeutic duplication that was
addressed elsewhere in the questionnaire, and an attachment that
was duplicative of information requested in a table and therefore
we no long have a CMS-R-153c. Additionally, we decreased the
overall number of problem categories and intervention types that
the states had to report to on to CMS by 50 percent. We added new
questions to several sections in the survey. We clarified that the
annual report will now be electronically submitted directly to the
Central Office (CO) instead of being submitted in hard copy through
the Regional Office.
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.