[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]
-----------------------------------------------------------------------
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