Cms-10193 The Medicare Clinical Laboratory Competitive Biddin

Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form

CMS 10193 LAB Application Form (without Track Changes) 07 06 06 -- jk edits 7-13-06

Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form

OMB: 0938-1008

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THE MEDICARE CLINICAL LABORATORY COMPETITIVE BIDDING DEMONSTRATION PROJECT

APPLICATION FORM

For CMS Use Only

Application Number

Date Application Received



A. BIDDING STATUS


ALL organizations currently supplying, or planning to supply, more than $1,000 in demonstration tests annually are required to complete this application. Bidders should complete all sections of this application. Non-bidders only need to complete sections A, B (items 1-6, 10,11) and G. The rules of the demonstration are found in the APPLICATION FORM: INSTRUCTIONS FOR COMPLETION. Check either 1 or 2 and indicate whether or not you are bidding:


1. The applicant is required to bid under the rules of the demonstration and is:

bidding on the demonstration tests

not bidding on the demonstration tests (and therefore will not receive Medicare Part B payment for demonstration tests)


2. The applicant is not required to bid under the rules of the demonstration and is:

bidding on the demonstration tests

not bidding on the demonstration tests (and therefore will receive Medicare Part B payment for demonstration tests)


B. APPLICANT INFORMATION


B1. Business and Ownership Information

1. Applicant’s Business Information

Applicant’s Legal Business Name


Mailing Address (Number, Street)


City


State

Zip Code


Telephone Number (Include Area Code)

Fax Number (Include Area Code)


Indicate the length of time the applicant completing this form has been doing business in the CBA. _________years, ______________months

2. Federal Tax Identification Number (TIN) _________________________________________________________________________________

3. “Doing Business As” Name ________________________________________________________________________________________

4. Type of Business

Type of Healthcare Organization


Independent Laboratory

Hospital

Physician Office

Outpatient/Ambulatory Surgery Center or Clinic

Nursing Home

Dialysis Facility

Home Health Agency

Other (please specify) ­­__________________________________________

Type of Ownership


Government (local or state)

Private non-profit

Proprietary, individual

Proprietary, partnership

Proprietary, corporate (privately held)

Proprietary, corporate (publicly traded)

Other (please specify) ­­__________________________________________

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938- . The time required to complete this information collection is estimated to average

1-100 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.




5. Ownership

Read the instructions for completion carefully. List individually each owner, partner, or managing organization of the applicant. If additional space is needed, check here and attach the additional information using the same format.

Owner #1 Legal Name as Reported to the IRS


Mailing Address (Number, Street)


City

State

Zip Code


Telephone Number (Include Area Code)

Fax Number (Include Area Code)


Federal Tax Identification Number (TIN)


Fiscal Intermediary (FI) Medicare Provider Number (if applicable)

Doing Business As” Name


Check all that apply and provide the relevant dates and percent ownership where applicable:


5% or more ownership interest (Effective date of ownership ___________________________ % ownership___________________________________________)

Managing Organization (Effective date of control of Managing Organization______________________________________________________________________)

Partner (Effective date of partnership _____________________________________________________________________________________________________)


Owner #2 Legal Name as Reported to the IRS


Mailing Address (Number, Street)


City

State

Zip Code


Telephone Number (Include Area Code)

Fax Number (Include Area Code)


Federal Tax Identification Number (TIN)


Fiscal Intermediary (FI) Medicare Provider Number (if applicable)

Doing Business As” Name


Check all that apply and provide the relevant dates and percent ownership where applicable:


5% or more ownership interest (Effective date of ownership ___________________________ % ownership___________________________________________)

Managing Organization (Effective date of control of Managing Organization______________________________________________________________________)

Partner (Effective date of partnership _____________________________________________________________________________________________________)


6. Business Establishment Information

(Current) Establishment/Incorporated

State Date (mm/dd/yyyy)

Additional Information


(Historic) Previously Established/Incorporated

State Date (mm/dd/yyyy)

Additional Information


B2. Quality and Medicare Information

7. Quality Assurance Contact


Name


Title


Mailing Address


City

State


Zip Code

Telephone Number (Include Area Code)

Fax Number (Include Area Code)


E-mail Address


8. Laboratory Registry

Have any of the applicant’s laboratories ever appeared on the annual Laboratory Registry under CLIA?

YES NO

If yes, please provide the laboratory name, laboratory director, address, CLIA identification number and date.




If yes, was the CLIA certificate Suspended Limited Revoked Other

9. Proficiency Testing

Check all programs the applicant’s laboratories currently participate in:

Accutest

AAB

CTS

EXCEL

MLE

New Jersey

CAP

AAFP

API

Pennsylvania

Puerto Rico

WSLH

Maryland

ASCP

New York State

May we contact the proficiency testing program(s)? YES NO (please explain below)




10. Laboratory(ies) Serving the CBA

If additional space is needed, check here and attach the additional information using the same format.

Laboratory #1 Legal Business Name


Mailing Address (Number, Street)


City

State

Zip Code


Laboratory Director (name)


Does this person direct other laboratories? YES NO

If yes, please list the name(s), address(es), and the CLIA Identification Number of the additional laboratory(ies).



Is this a Medicare certified facility? YES NO

If yes, please indicate the Fiscal Intermediary (FI) Medicare Provider Number ________________________________

Provider Number Assigned by Medicare Part B Carrier (indicate “n/a” if not applicable)

National Provider Identification (NPI) number


CLIA Identification Number

Hospital or Part A Medicare Provider Number (indicate “n/a” if not applicable)


Indicate the type of CLIA certificate held by the laboratory and the expiration date of the certificate.

Certificate of Compliance __________________________(expiration date)

Certificate of Accreditation __________________________(expiration date)

If the laboratory holds a Certificate of Accreditation under CLIA, please indicate the accrediting organization(s).

JCAHO

AOA

AABB

CAP

COLA

ASHI

May we contact the accrediting organization(s)? YES NO

Laboratory #2 Legal Business Name


Mailing Address (Number, Street)


City

State

Zip Code


Laboratory Director (name)


Does this person direct other laboratories? YES NO

If yes, please list the names and addresses of the additional laboratories.


Is this a Medicare certified facility? YES NO

If yes, indicate the Fiscal Intermediary (FI) Medicare Provider Number ________________________________

Provider Number Assigned by Medicare Part B Carrier (indicate “n/a” if not applicable)

National Provider Identification (NPI) number


CLIA Identification Number

Hospital or Part A Medicare Provider Number (indicate “n/a” if not applicable)



10. Laboratory (ies) Serving the CBA (continued)

Laboratory #2 (continued)

Indicate the type of CLIA certificate held by the laboratory and the expiration date of the certificate.

Certificate of Compliance __________________________(expiration date)

Certificate of Accreditation __________________________(expiration date)

If the laboratory holds a Certificate of Accreditation under CLIA, please indicate the accrediting organization(s).

JCAHO

AOA

AABB

CAP

COLA

ASHI

May we contact the accrediting organization(s)? YES NO

Laboratory #3 Legal Business Name


Mailing Address (Number, Street)


City

State

Zip Code


Laboratory Director (name)


Does this person direct other laboratories? YES NO

If yes, please list the names and addresses of the additional laboratories.




Is this a Medicare certified facility? YES NO

If yes, indicate the Fiscal Intermediary (FI) Medicare Provider Number ________________________________

Provider Number Assigned by Medicare Part B Carrier (indicate “n/a” if not applicable)

National Provider Identification (NPI) number


CLIA Identification Number

Hospital or Part A Medicare Provider Number (indicate “n/a” if not applicable)


Indicate the type of CLIA certificate held by the laboratory and the expiration date of the certificate.

Certificate of Compliance __________________________(expiration date)

Certificate of Accreditation __________________________(expiration date)

If the laboratory holds a Certificate of Accreditation under CLIA, please indicate the accrediting organization(s).

JCAHO

AOA

AABB

CAP

COLA

ASHI

May we contact the accrediting organization(s)? YES NO


B3. Financial and Legal Information

11. Authorized Official(s)

Authorized Official(s) First Name

Last Name

Title


Telephone Number (Include Area Code)

E-mail Address


Authorized Official(s) First Name

Last Name

Title


Telephone Number (Include Area Code)

E-mail Address


12. Bank References

Reference #1 Institution Name


Line of Credit (if any, in dollars)

Account Number(s)

Contact Person

Telephone Number (Include Area Code)


Reference #2 Institution Name

Line of Credit (if any, in dollars)


Account Number(s)

Contact Person

Telephone Number (Include Area Code)


13. Financial Information

Please submit the financial information requested in the instructions for this question. An authorized official of the applicant should sign below to certify the submitted financial information.

I HEREBY CERTIFY that I have examined the accompanying financial statement and that to the best of my knowledge and belief, it is a true, correct and complete statement prepared from books and records that we have prepared in accordance with the Generally Accepted Accounting Principles.

Authorized Official (Print)

Title

Date


Authorized Official (Signature)


14. Adverse Legal Actions

Have any of the adverse legal actions listed in Table A (see instructions) been imposed against the applicant, any of the applicant’s subcontractors or any of the applicant’s owners? If yes, report each adverse legal action, when it occurred, the law enforcement authority/court/administrative body that imposed the action and the resolution. Attach a copy of the adverse legal action documentation(s) and resolution(s).





Is the applicant, any of the applicant’s subcontractors or any of the applicant’s owners currently the subject of an investigation that could potentially result in imposition of an adverse legal action listed in Table A (see instructions)? If yes, report the circumstances and status of the investigation.




C. GEOGRAPHIC COVERAGE, TEST MENU, AND SUBCONTRACTING


1. Geographic Coverage

Indicate the zip codes that you currently serve within the CBA. If you serve all of the zip codes in a particular county, you may enter the name of the county.



Are there any specific tests provided by the applicant that are not available for all of the zip codes and counties listed above? YES NO

If yes, please provide the HCPCS codes for these tests as well as a brief explanation for why they can not be provided to all of the zip codes and counties you serve in the CBA.



Do you plan to expand your service area under the competitive bidding demonstration project? YES NO

If yes, indicate the additional zip codes or counties you will serve within the CBA:




2. Specimen Transport and Logistics

Check all that apply


Specimens are collected by client and transported via courier service (e.g., local courier, FedEx)

Applicant provides specimen collection at client location and transports specimen to testing laboratory

Applicant provides specimen pick-up service for routine and STAT collection

Applicant provides specimen collection on-site at laboratory (primary address)

Applicant provides specimen collection sites within the demonstration area (addresses to be listed below)


Provide a copy of your current requisition or test request form. If not available, provide an explanation.


3. Specimen Collection Locations


Location #1 Name


Mailing Address (Street)


City

State

Zip Code


Function (check all that apply)

Only Specimen Drop Off

Venipuncture

Limited Laboratory Testing (please specify) __________________________________________________



3. Specimen Collection Locations (continued)

Location #2 Name


Mailing Address (Street)


City

State

Zip Code


Function (check all that apply)

Only Specimen Drop Off

Venipuncture

Limited Laboratory Testing (please specify) __________________________________________________

Location #3 Name


Mailing Address (Street)


City

State

Zip Code


Function (check all that apply)

Only Specimen Drop Off

Venipuncture

Limited Laboratory Testing (please specify) __________________________________________________

4. Test Menu

Indicate the CLIA specialty(ies) of testing performed in-house.

Histocompatibility

Microbiology

Diagnostic Immunology

Chemistry

Hematology

Immunohematology

Pathology

Radiobioassay

Clinical Cytogenetics

Other (specify) _________


How will your laboratory provide a comprehensive demonstration test menu (for Medicare beneficiaries) under the Competitive Bidding Demonstration Project? Check all that apply.

Laboratory currently offers demonstration test menu (in-house testing)

Laboratory plans to expand (in-house testing, provide additional information in question 6)

Laboratory currently subcontracts/refers to provide demonstration test menu (provide additional information in question 5)

Laboratory plans to subcontract/refer to provide demonstration test menu (provide additional information in question 5)

Other (explain)










5. Subcontracting/Referred Tests

Do you “send out” or refer laboratory tests to another laboratory, or plan to do so under the demonstration? YES NO

If yes, please identify the legal entities you currently or anticipate subcontracting or referring tests to, specify what tests will be subcontracted/referred, and specify the prices charged to the applicant for subcontracted/referred tests.


Subcontractor/Reference Laboratory Legal Name


Demonstration Tests or Specialties to be Subcontracted/Referred

Copies of Subcontractor/Reference Laboratory Prices Attached?




YES NO Pending




YES NO Pending




YES NO Pending




YES NO Pending




YES NO Pending




YES NO Pending







5. Subcontracting/Referred Tests (continued)

If subcontractor/reference laboratory prices charged to the applicant are not attached or are pending, please explain.

If necessary, attach additional pages to explain subcontractor/reference laboratory relationships, tests, and prices.




6. Expansion

Do you plan to expand if awarded a competitive bid contract? YES NO If yes, describe your expansion plan:





In what month/year do you anticipate that the added capacity from your expansion plan will become available?____________________ (month/year)



D. BID PRICES, VOLUME AND CAPACITY


1. Test Volume

What was the total number of tests provided for residents of this CBA by the applicant during calendar year 2005?

0-50,000

50,001-100,000

100,001 – 250,000

250,001 – 500,000

500,001-750,000

750,001- less than 1 million

1 million – 5 million

More than 5 million

What percentage was for Medicare beneficiaries?

0% - 10%

11%-20%

21%-30%

31%-40%

41%-50%

51%-60%

61%-70%

71%-80%

81%-90%

91%-100%

2. Revenue

What was the total revenue collected from tests provided for residents of this CBA by the applicant during calendar year 2005?

$0-$250,000

$250,001 - $500,000

$500,001 - $750,000

$750,001 - less than $1 million

$1 million - less than $3 million

$3 million - less than $6 million

$6 million - $10 million

More than $10 million

What percentage was collected from Medicare?

0% - 10%

11%-20%

21%-30%

31%-40%

41%-50%

51%-60%

61%-70%

71%-80%

81%-90%

91%-100%

3. Non-patient Test Percentage

If you are a hospital or physician office laboratory (or other organization with patients), what percentage of your total test volume in the CBA is provided to non-patients? For example, if you are a hospital providing 15% of your tests as “outreach” business to persons who are not inpatients or outpatients of your organization, check the 11-20% box.


If you are an independent clinical laboratory, check here.

0% - 10%

11%-20%

21%-30%

31%-40%

41%-50%

51%-60%

61%-70%

71%-80%

81%-90%

91%-100%



4 . Medicare Bid Price by HCPCS Code


Provide your Medicare bid price in column D for each HCPCS code.


5. Current Volume and Maximum Annual Capacity


Indicate the applicant’s current total (all payers) annual test volume and estimated maximum annual test capacity by CLIA specialty for all residents of the CBA.


CLIA Specialty


Current Volume


Capacity

Histocompatability





Immunohematology





Microbiology





Pathology





Diagnostic Immunology





Radiobioassay





Chemistry





Clinical Cytogenetics





Hematology





Other (specify)__________________________







Explain any extra capacity you reported above. Check all that apply. Attach additional sheets to explain if necessary.


Extra capacity in current configuration

Expansion plan reported in Section C, question 6

Subcontracting/Referrals

Other (explain) ___________________________________________________________________________________________________________________


Will all of the extra capacity reported above, if any, be available to provide demonstration tests?

YES NO (explain)

If necessary, attach additional sheets to explain your capacity to expand demonstration test volume..





E. Additional Information (Optional)

(Specialized testing services provided, etc.--see instructions)




































F. CERTIFYING STATEMENT

I, the undersigned, certify to the following:


  1. I have read the contents of this application. By my signature, I certify that the information contained herein is true, correct, and complete.

  2. I attest that the applicant will be able to perform the activities in compliance with the terms and conditions of the demonstration.

  3. I attest that the applicant agrees to notify CMS in writing of any changes that may jeopardize the applicant’s ability to meet the qualifications stated in this application prior to such change or within 15 days of the effective date of such change. If the organization becomes aware that any information in this application is not true, correct, or complete at any time during the application period (or during the contract period if the applicant is awarded a contract), the organization shall notify CMS in writing immediately.

  4. I understand that, in accordance with 18 U.S.C. § 1001, any omission, misrepresentation, or falsification of any information contained in this application or contained in any communication supplying information to CMS to complete or verify this application may be punishable by criminal, civil, or administrative actions including revocation of approval, fines, and/or imprisonment.

  5. I certify that I am a representative, officer, chief executive officer, or general partner of the applicant and am authorized to submit and certify an application for the Medicare Clinical Laboratory Competitive Bidding Demonstration Project on behalf of the applicant.


Authorized Official Name (First, Middle, Last)


Title/Position

Signature


Date


Form CMS – 10193 Page 10 of 10

File Typeapplication/msword
File TitleMEDICARE CLINICAL LABORATORY COMPETITIVE BIDDING PROGRAM
AuthorJyoti Aggarwal
Last Modified ByCMS
File Modified2006-07-13
File Created2006-07-13

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