Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 8967 

specific policies and procedures in 

place that require accredited programs 

to have a systematic process for 

implementing a continuous quality 

improvement process and plan, that is, 

programs are required to develop 

projects of their own design, and to 

specify the outcome measures they are 

currently tracking, providing a rationale 

for selecting the outcome measures. 

Furthermore, AADE also requires an 

accredited program to undertake quality 

improvement activities annually. 

Comment: One commenter stated that 

AADE’s proposed re-accreditation 

methodology that would perform 

random checks on providers’ 

professional licenses, certificates and 

continuing education, would be 

inadequate, since the staffing turnover 

in DSMT programs is high. Random 

credential validation could pose a 

potential quality assurance problem. 

Response: We agree with the 

commenter that an accrediting 

organization should comprehensively 

validate professional licenses, 

certificates and continuing education in 

the re-accreditation phases to ensure 

DSMT programs provide quality care by 

qualified staff. AADE’s reaccreditation 

methodology now requires programs to 

notify the AADE of any change in staff 

status, and to maintain documentation 

of current verification of professional 

licenses, certificates and continuing 

education for inspection during the reaccreditation process. 

Comment: One commenter 

recommended that AADE adopt 

NSDSMEP standard #10, requiring the 

DSMT entity to measure the 

effectiveness of the education process 

and determine opportunities for 

improvement using a written 

continuous quality improvement plan 

that describes and documents a 

systematic review of the entity’s process 

and outcome data. 

Response: As stated earlier, AADE is 

adopting the NSDSMEP in its entirety, 

including standard #10. 

Comment: A commenter expressed 

concerns that AADE standards would 

require its accredited programs to use 

the AADE7TM self-care behaviors and 

continuum of outcomes framework. 

This could create a potential conflict of 

interest if AADE-approved entities were 

required to purchase the AADE7TM

framework as a condition of 

accreditation. 

Response: We do not believe there is 

a conflict of interest if a prospective 

program makes the business decision to 

be accredited by the AADE and 

purchase the AADE7TM to enhance its 

data collection and quality 

improvement practices. Also, AADE 

allows its accredited programs the 

option to use other data collection tools. 

DSMT programs also have the option of 

seeking accreditation by either of the 

other NAOs for DSMT: the American 

Diabetes Association or the Indian 

Health Service (accrediting American 

Indian and Alaska Native programs). 

Comment: One commenter suggested 

that in addition to granting deeming 

authority to NAOs, CMS should expand 

outreach efforts to increase access to 

DSMT programs by educating 

beneficiaries, physicians, and qualified 

non-physician practitioners (for 

example, nurse practitioners, physician 

assistants) to enhance their 

understanding of the DSMT referral 

process. 

Response: This is beyond the scope of 

this final notice. However, educating 

more professionals about how to care for 

persons with diabetes, and educating 

more persons with diabetes about selfcare is an area that we consider to be 

beneficial. Currently, there are a number 

of studies being conducted by our 

Quality Improvement Organizations. We 

expect to build on the lessons from 

these studies to further reduce 

disparities between health care received 

by minority populations and to be able 

to measure improvements as evidenced 

by these studies. It is anticipated that 

the studies will provide an opportunity 

to learn the most appropriate treatment 

modalities for a variety of serious health 

concerns, including diabetes, that are 

prevalent in our society. 

IV. Provisions of the Final Notice 

AADE’s application to become a NAO 

for purposes of DSMT as authorized 

under Section 1861 (qq) of the Act is 

approved for a period of three (3) years 

and becomes effective 30 days after 

publication of this final notice. This 

approval is subject to renewal 

subsequent to the receipt of an 

application from the AADE and subject 

to review, evaluation and approval of its 

program. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 6, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–3287 Filed 2–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4142–PN] 

Medicare Program; Application of the 

Utilization Review Accreditation 

Commission (URAC) for Deeming 

Authority for Medicare Prescription 

Drug Plan (PDP) Sponsors 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces the application of the 

Utilization Review Accreditation 

Commission (URAC) for deeming 

authority as a national accreditation 

organization for prescription drug plan 

sponsors participating in the Voluntary 

Medicare Prescription Drug Benefit 

Program. This announcement describes 

the criteria to be used in evaluating the 

application and provides information 

for submitting comments during a 30 

day public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on March 30, 2009. 

ADDRESSES: In commenting, please refer 

to file code CMS–4142–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment of 

Submission’’ and enter the file code to 

find the document accepting comments. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–4142– 

PN, P.O. Box 8016, Baltimore, MD 

21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 


rwilkins on PROD1PC63 with NOTICES2
8968 Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–4142–PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses: 

a. Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

b. 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

7195 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: Sue 

Bradshaw, (410) 786–2896. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive prescription 

drug benefits through a Prescription 

drug plan (PDP) sponsor that has a 

prescription drug plan contract with the 

Centers for Medicare & Medicaid 

Services (CMS). The regulations 

specifying the Medicare requirements 

that must be met in order for a PDP 

sponsor to enter into a prescription drug 

plan contract with CMS are located at 

42 CFR part 423. These requirements 

implement Part D of Title XVIII of the 

Social Security Act (the Act), which 

specifies the prescription drug benefits 

that a PDP sponsor must provide and 

the requirements that the organization 

must meet to be a PDP sponsor. Other 

relevant sections of the Act are parts A 

and B of Title XVIII and part A of Title 

XI of the Act, pertaining to the provision 

of services by Medicare certified 

providers and suppliers. 

Generally, for an organization to enter 

into a PDP contract, the organization 

must be licensed by the State as a risk 

bearing organization as set forth at 42 

CFR 423.504(b)(2) of our regulations. 

Additionally, the organization must file 

an application demonstrating that it 

meets other Medicare requirements in 

part 423 of our regulations. Following 

approval of the contract, we engage in 

routine monitoring and oversight audits 

of the PDP sponsors to ensure 

continuing compliance. The monitoring 

and oversight audit process is 

comprehensive and uses a written 

protocol that itemizes the Medicare 

requirements that the PDP sponsors 

must meet. 

As an alternative for meeting some 

Medicare requirements, a PDP sponsor 

may be exempt from CMS monitoring of 

certain requirements in subsets listed in 

section 1860D–4(j) of the Act (crossreferencing section 1852(e)(4)(B) of the 

Act) as a result of a PDP sponsor’s 

accreditation by a CMS-approved 

accrediting organization (AO). In 

essence, the Secretary ‘‘deems’’ that the 

PDP has met the Medicare requirements 

via its accreditation, based on a 

previous determination that the AO’s 

standards are at least as stringent as 

Medicare requirements. As we specify at 

§ 423.168(b)(2)(ii) of our regulations, the 

term for which an AO may be approved 

by CMS may not exceed 6 years. For 

continuing approval, the AO will have 

to re-apply to CMS. An organization that 

applies for PDP sponsor deeming 

authority is generally recognized by the 

industry as an entity that accredits PDP 

sponsors that are licensed as 

prescription drug plan sponsors. Section 

1852(e)(4)(C) of the Act requires that 

within 210 days of receipt of an 

application, the Secretary shall 

determine whether the applicant meets 

criteria specified in section 1865(b)(2) 

(redesignated in 2008 as section 

1865(a)(2)) of the Act. 

On October 14, 2008 URAC submitted 

to CMS an application for deeming 

authority with respect to Part D 

sponsors’ compliance with the 

following PDP plan requirements, as set 

out at 42 CFR 423.165(b): 

■ Access to covered drugs; 

■ Confidentiality and accuracy of 

enrollee prescription drug records; 

■ Drug utilization management, 

quality assurance measure and systems, 

medication therapy management; and, 

■ The sponsors’ programs to control 

fraud, waste and abuse. To be approved 

for deeming authority, an accrediting 

organization must demonstrate that its 

accreditation program requirements 

meet or exceed the Medicare 

requirements for which it is seeking the 

authority to deem compliance. 

II. Provisions of the Proposed Notice 

The purpose of this proposed notice 

is to notify the public of the application 

of the Utilization Review Accreditation 

Commission for deeming authority as a 

national accreditation organization for 

prescription drug plan sponsors 

participating in the Voluntary Medicare 

Prescription Drug Benefit Program. This 

announcement describes the criteria to 

be used in evaluating the application 

and provides information for submitting 

comments during a 30-day public 

comment period. 

Deeming Application Approval Process 

The application process for deeming 

authority includes a review of URAC’s 

application in accordance with the 

criteria specified by our regulations at 

§ 422.171(a). This includes, but is not 

limited to, the following: 

• The equivalency of URAC’s 

requirements for PDP sponsors to CMS’s 

comparable PDP sponsor requirements. 

• URAC’s survey process, to 

determine the following: 

+ The frequency of surveys. 

+ The types of forms, guidelines, and 

instructions used by surveyors. 

+ Descriptions of the accreditation 

decision making process, deficiency 

notification and monitoring process, 

and compliance enforcement process. 

• Detailed information about 

individuals who perform accreditation 

surveys including— 

+ Size and composition of the survey 

team; 

+ Education and experience 

requirements for the surveyors; 

+ In-service training required for 

surveyor personnel; 


rwilkins on PROD1PC63 with NOTICES2
Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 8969 

+ Surveyor performance evaluation 

systems; and 

+ Conflict of interest policies relating 

to individuals in the survey and 

accreditation decision process. 

• Descriptions of the organization’s— 

+ Data management and analysis 

system; 

+ Policies and procedures for 

investigating and responding to 

complaints against accredited 

organizations; and+ Types and 

categories of accreditation offered and 

PDP sponsors and MA organizations 

currently accredited within those types 

and categories. 

In accordance with § 423.171(b) of our 

regulations, the applicant must provide 

documentation relating to the following: 

• Its ability to provide data in a CMS 

compatible format. 

• The adequacy of personnel and 

other resources necessary to perform the 

required surveys and other activities. 

• Assurances that it will comply with 

ongoing responsibility requirements 

specified in § 423.168(c) of our 

regulations. 

Additionally, the accrediting 

organization must provide CMS with 

the opportunity to observe its 

accreditation process on site at a 

managed care organization and must 

provide any other information that CMS 

requires to prepare for an onsite visit. 

These site visits will help to verify that 

the information presented in the 

application is correct and to make a 

determination on the application. 

In accordance with section 

1865(a)(3)(A) of the Act and our 

regulations at § 423.168(b)(1), this 

proposed notice solicits public 

comment on the ability of URAC’s 

accreditation program to meet or exceed 

the Medicare requirements for PDP 

sponsors which it seeks authority to 

deem as being in compliance with such 

requirements. In accordance with 

§ 423.168(b)(1)(iii), comments are due 

[at least 30] days after the date of 

publication of this proposed notice. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 13, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–4320 Filed 2–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1497–N] 

Medicare Program; Public Meetings in 

Calendar Year 2009 for All New Public 

Requests for Revisions to the 

Healthcare Common Procedure Coding 

System (HCPCS) Coding and Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

dates, time, and location of the 

Healthcare Common Procedure Coding 

System (HCPCS) public meetings to be 

held in calendar year 2009 to discuss 

our preliminary coding and payment 

determinations for all new public 

requests for revisions to the HCPCS. 

These meetings provide a forum for 

interested parties to make oral 

presentations or to submit written 

comments in response to preliminary 

coding and payment determinations. 

Discussion will be directed toward 

responses to our specific preliminary 

recommendations and will include all 

items on the public meeting agenda. 

DATES: Meeting Dates: The following are 

the 2009 HCPCS public meeting dates: 

1. Tuesday, April 28, 2009, 9 a.m. to 

5 p.m., eastern daylight time (e.d.t.) 

(Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

2. Wednesday, April 29, 2009, 9 a.m. 

to 5 p.m., e.d.t. (Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

3. Tuesday, May 12, 2009, 9 a.m. to 

5 p.m., e.d.t. (Supplies and Other). 

4. Wednesday, May 13, 2009, 9 a.m. 

to 5 p.m., e.d.t. (Supplies and Other). 

5. Wednesday, May 27, 2009, 9 a.m. 

to 5 p.m., e.d.t. (Orthotics and 

Prosthetics). 

6. Thursday, May 28, 2009, 9 a.m. to 

5 p.m., e.d.t. (Durable Medical 

Equipment (DME) and Accessories). 

7. Thursday, July 9, 2009, 9 a.m. to 5 

p.m., e.d.t. (Durable Medical Equipment 

(DME) and Accessories, including 

Negative Pressure Wound Therapy 

(NPWT) devices. 

Deadlines for Primary Speaker 

Registration and Presentation Materials: 

The deadline for registering to be a 

primary speaker, and submitting 

materials and writings that will be used 

in support of an oral presentation are as 

follows: 

• April 14, 2009 for the April 28 and 

29, 2009 public meetings. 

• April 28, 2009 for the May 12 and 

13, 2009 public meetings. 

• May 13, 2009 for the May 27 and 

28, 2009 public meetings. 

• June 25, 2009 for the July 9, 2009 

public meeting. 

Deadlines for All Other Attendees 

Registration: All individuals must 

register for each date that they plan on 

attending. The registration deadlines are 

different for each meeting. Registration 

deadlines are as follows: 

• April 21, 2009 for the April 28 and 

29, 2009 public meeting dates. 

• May 5, 2009 for the May 12 and 13, 

2009 public meeting dates. 

• May 20, 2009 for the May 27 and 

28, 2009 public meetings. 

• July 2, 2009 for the July 9, 2009 

public meeting. 

Deadlines for Requesting Special 

Accommodations: 

• April 14, 2009 for the April 28 and 

29, 2009 public meeting dates. 

• April 28, 2009 for the May 12 and 

13, 2009 public meeting dates. 

• May 13, 2009 for the May 27 and 

28, 2009 public meetings. 

• June 25, 2009 for the July 9, 2009 

public meeting. 

Deadline for Submission of Written 

Comments: Written comments must be 

received by the date of meeting at which 

a request is scheduled for discussion. 

ADDRESSES: Meeting Location: The 

public meetings will be held in the main 

auditorium of the central building of the 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 


rwilkins on PROD1PC63 with NOTICES2