[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60845-60847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241, CMS-10412, CMS-R-263, CMS-R-262, CMS-
10142 and CMS-855(O)]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Survey of Retail 
Prices: Payment and Utilization Rates, and Performance Rankings; Use: 
CMS will develop a National Average Drug Acquisition Cost (NADAC) for 
States to consider when developing reimbursement methodology. The NADAC 
is a new pricing benchmark that will be based on the national average 
costs that pharmacies pay to acquire Medicaid covered outpatient drugs. 
It is intended to provide States with a more accurate reference price 
to base reimbursement for prescription drugs and will be based on drug 
acquisition costs collected directly from pharmacies through a 
nationwide survey process. This survey will be conducted on a monthly 
basis to ensure that the NADAC reference file remains current and up-
to-date. A NADAC Survey Request for Information has been developed to 
send to random pharmacies for voluntary completion. CMS proposes to add 
the survey to an existing collection, ``Annual State Report and Annual 
State Performance Rankings.'' The requirements and burden associated 
with the annual report/rankings are unaffected by this proposed action; 
Form Number: CMS-10241 (OCN: 0938-1041); Frequency: Biennially, Once; 
Affected Public: Private Sector; Business or other for-profits; Number 
of Respondents: 30,000; Total Annual Responses: 30,000; Total Annual 
Hours: 15,000. (For policy questions regarding this collection contact 
Lisa Ferrandi at 410-786-5445. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Section 1115 Demonstration: Long Term Services 
and Supports and Other Service Models for Individuals with Disabilities 
and Chronic Conditions; Use: Section 1115 of the Social Security Act 
provides the Secretary of Health and Human Services broad authority to 
authorize experimental, pilot, or demonstration projects likely to 
assist in promoting the objectives of the Medicaid statute. Flexibility 
under Section 1115 is sufficiently broad to allow states to test 
substantially new ideas of policy merit. States seeking interventions 
for individuals needing LTSS to lower costs, improve care and improve 
health can utilize the 1115 demonstration to test and deliver 
innovative services and approaches to better and more efficiently meet 
the needs of this population. Section 1115 demonstrations provide a 
vehicle for innovations in both care delivery and payment 
methodologies. Demonstrations must be ``budget neutral'' over the life 
of the project, meaning they cannot be expected to cost the Federal 
government more than it would cost without the waiver. State Medicaid 
agencies are responsible for developing section 1115 demonstration 
applications and submitting them to CMS; Form Number: CMS-10412 (OCN: 
0938-New); Frequency: Once; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 56; Total Annual Responses: 56; 
Total Annual Hours: 2,240. (For policy questions regarding this 
collection contact Adrienne Delozer at 410-786-0278. For all other 
issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Site 
Investigation for Durable Medical Equipment (DME) Suppliers; Use: CMS 
is mandated to identify and implement measures to prevent fraud and 
abuse in the Medicare program. To meet this challenge, CMS has moved 
forward to improve the quality of the process for enrolling suppliers 
into the Medicare program by establishing a uniform application for 
enumerating suppliers of durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS). Implementation of enhanced procedures 
for verifying the enrollment information has also improved the 
enrollment process. As part of this process, verification of compliance 
with supplier standards is necessary. The site investigation form has 
been used in the past to aid the Medicare contractor (the National 
Supplier Clearinghouse and/or its subcontractors) in verifying 
compliance with the required supplier standards found in 42 CFR 
424.57(c). The primary function of the site investigation form is to 
provide a standardized, uniform tool to gather information from a 
DMEPOS supplier that tells us whether it meets certain qualifications 
to be a DMEPOS supplier (as found in 42 CFR 424.57(c)) and where it 
practices or renders its services.
    This site investigation form collects the same information as its 
predecessor, with the exception of one new yes/no question under the 
``Records and Telephone'' section (question 11(a)) used to verify if 
the DMEPOS supplier maintains physician ordering/referring records for 
the supplies and/or services it renders to Medicare beneficiaries (if 
applicable). This information is required by Section 1833(q) of the 
Social Security Act which states that all physicians and non-physician 
practitioners that meet the definitions at section 1861(r) and 
1842(b)(18)(C) be uniquely identified for all claims for services that 
are ordered or referred. Other information collected on this site 
investigation remains unchanged, but has been reformatted for greater 
functionality. Form Number: CMS-R-263 (OCN: 0938-0749); Frequency: 
Once; Affected Public: Private Sector--Business or other for-profits 
and not-for-profit institutions; Number of Respondents: 30,000; Total 
Annual Responses: 30,000; Total Annual Hours: 15,000. (For policy 
questions regarding this collection contact Kimberly McPhillips at 410-

[[Page 60846]]

786-5374. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Plan Benefit 
Package (PBP) and Formulary Submission for Medicare Advantage (MA) 
Plans and Prescription Drug Plans (PDP); Use: Under the Medicare 
Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug 
Plan (PDP) organizations are required to submit plan benefit packages 
for all Medicare beneficiaries residing in their service area. The plan 
benefit package submission consists of the Plan Benefit Package (PBP) 
software, formulary file, and supporting documentation, as necessary. 
MA and PDP organizations use the PBP software to describe their 
organization's plan benefit packages, including information on 
premiums, cost sharing, authorization rules, and supplemental benefits. 
They also generate a formulary to describe their list of drugs, 
including information on prior authorization, step therapy, tiering, 
and quantity limits. Additionally, CMS uses the PBP and formulary data 
to review and approve the plan benefit packages proposed by each MA and 
PDP organization.
    CMS requires that MA and PDP organizations submit a completed PBP 
and formulary as part of the annual bidding process. During this 
process, organizations prepare their proposed plan benefit packages for 
the upcoming contract year and submit them to CMS for review and 
approval.
    CMS is requesting to continue its use of the PBP software and 
formulary submission for the collection of benefits and related 
information for CY 2013 through CY 2015. CMS estimates that 571 MA 
organizations and 64 PDP organizations will be required to submit the 
plan benefit package information in CY 2013. Based on operational 
changes and policy clarifications to the Medicare program and continued 
input and feedback by the industry, CMS has made the necessary changes 
to the plan benefit package submission. Form Number: CMS-R-262 (OCN: 
0938-0763); Frequency: Yearly; Affected Public: Private Sector--
Business or other for-profits and not-for-profit institutions; Number 
of Respondents: 635; Total Annual Responses: 6,015; Total Annual Hours: 
53,291. (For policy questions regarding this collection contact Kristy 
Holtje at 410-786-2209. For all other issues call 410-786-1326.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Bid Pricing Tool 
(BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans 
(PDP); Use: Under the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA), and implementing regulations at 42 
CFR, Medicare Advantage organizations (MAO) and Prescription Drug Plans 
(PDP) are required to submit an actuarial pricing ``bid'' for each plan 
offered to Medicare beneficiaries for approval by the Centers for 
Medicare & Medicaid Services (CMS).
    MAOs and PDPs use the Bid Pricing Tool (BPT) software to develop 
their actuarial pricing bid. The information provided in the BPT is the 
basis for the plan's enrollee premiums and CMS payments for each 
contract year. The tool collects data such as medical expense 
development (from claims data and/or manual rating), administrative 
expenses, profit levels, and projected plan enrollment information. By 
statute, completed BPTs are due to CMS by the first Monday of June each 
year.
    CMS reviews and analyzes the information provided on the Bid 
Pricing Tool. Ultimately, CMS decides whether to approve the plan 
pricing (i.e., payment and premium) proposed by each organization. CMS 
is requesting to continue its use of the BPT for the collection of 
information for CY2013 through CY2015. Form Number: CMS-10142 (OCN: 
0938-0944); Frequency: Yearly; Affected Public: Private Sector--
Business or other for-profits and not-for-profit institutions; Number 
of Respondents: 530; Total Annual Responses: 4,770; Total Annual Hours: 
143,100. (For policy questions regarding this collection contact Diane 
Spitalnic at 410-786-5745. For all other issues call 410-786-1326.)
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Registration Application; Use: The CMS 855O allows a physician to 
receive a Medicare identification number (without being approved for 
billing privileges) for the sole purpose of ordering and referring 
Medicare beneficiaries to Medicare approved providers and suppliers. 
This new Medicare registration application form allows physicians who 
do not provide services to Medicare beneficiaries to be given a 
Medicare identification number without having to supply all the data 
required for the submission of Medicare claims. It also allows the 
Medicare program to identify ordering and referring physicians without 
having to validate the amount of data necessary to determine claims 
payment eligibility (such as banking information), while continuing to 
identify the physician's credentials as valid for ordering and 
referring purposes. Since the physicians and non-physician 
practitioners submitting this application are not enrolling in Medicare 
to submit claims but are only registering with Medicare as eligible to 
order and refer, CMS believes changing the title from Medicare 
Enrollment Application to Medicare Registration Application better 
captures the actual purpose of this form.
    Where appropriate, CMS has changed all references to enrollment or 
enrolling to registration and registering and Medicare billing number 
to National Provider Identifier. CMS also added a check box to allow 
physicians and non-physician practitioners to withdraw from the 
ordering and referring registry. A section to collect information on 
professional certifications was added for those practitioners who are 
not professionally licensed. Editorial and formatting corrections were 
made in response to prior comments received during the approval of the 
current version of this application. Other minor editorial and 
formatting corrections were made to better clarify the purpose of this 
application. Form Number: CMS-855(O) (OCN: 0938-1135); Frequency: 
Occasionally; Affected Public: Individuals; Number of Respondents: 
48,500; Total Annual Responses: 48,500; Total Annual Hours: 24,125. 
(For policy questions regarding this collection contact Kimberly 
McPhillips at 410-786-5374. For all other issues call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or E-mail your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected], or call 
the Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments must be received by November 29, 2011, and 
submitted in one of the following ways:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following

[[Page 60847]]

address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: September 27, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-25274 Filed 9-29-11; 8:45 am]
BILLING CODE 4120-01-P