[Federal Register Volume 67, Number 42 (Monday, March 4, 2002)]
[Notices]
[Pages 9741-9743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-843 and CMS-841, 842, 844-853]


Agency Information Collection Activities: Comment Request

AGENCY: Centers for Medicare and 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 and Medicaid 
Services (CMS) (formerly known as the Health Care Financing 
Administration (HCFA), Department of Health and Human Services, 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.
    Type of Information Collection Request: Reinstatement, without 
change, of a previously approved collection for which approval has 
expired; Title of Information Collection: Durable Medical Equipment 
Regional Carrier, Power Wheel Chair Certificate of Medical Necessity; 
Form No.: CMS-843; Use: This information is needed to correctly process 
claims and ensure that claims are properly paid. This form contains 
medical information necessary to make an appropriate claim 
determination. Suppliers and physicians will complete these forms; 
Frequency: On occasion; Affected Public: Business or other for-profit, 
not-for-profit institutions, and Federal Government; Number of 
Respondents: 2,700; Total Annual Responses: 129,000; Total Annual 
Hours: 32,250.
    Type of Information Collection Request: Reinstatement, without 
change, of a previously approved collection for which approval has 
expired; Title of Information Collection: Durable Medical Equipment 
Regional Carrier, Certificate of Medical Necessity (CMS-841, 842, 844-
853); Form No.: CMS-841,842, 844-853 (OMB# 0938-0679); Use: This

[[Page 9742]]

information is needed to correctly process claims and ensure that 
claims are properly paid. These forms contain medical information 
necessary to make an appropriate claim determination. Suppliers and 
physicians will complete these forms; Frequency: On occasion; Affected 
Public: Business or other for-profit, not-for-profit institutions, and 
Federal Government; Number of Respondents: 137,300; Total Annual 
Responses: 6.7 million; Total Annual Hours: 1.13 to 1.7 million.
    As the result of the town hall meetings held last year at OMB, CMS 
received a large volume of comments and agreed to most of the proposed 
changes. Proposed changes included:

Proposed Changes to CMS Form 843 Durable Medical Equipment Certificates 
of Medical Necessity (CMNs)

1. For Form 843 the Disclosure Statement Will Change

     The address for suggestions will read, ``CMS, 7500 
Security Boulevard, N2-14-26, Baltimore, Maryland 21244-1850 and the 
Office of the Information and Regulatory Affairs, Office of 
Management and Budget, Washington, D.C. 20503.''
     The timeframe to complete the CMN will remain at 15 
minutes.

2. For Form 843 the Health Care Financing Administration (HCFA) 
Would Change to Centers for Medicaid & Medicare Services (CMS)

     Top left of all forms will say ``U.S. Department of 
Health & Human Services, Centers for Medicaid & Medicare Services.''
     Bottom left will say ``FORM CMS__form number goes 
here.__''

3. Verbiage to the Instructions on the Back Page for HCFA Form 843

     Has been changed from ``ordering'' physician to 
``treating'' physician.

4. DMERC Form Number Will Need Changed

     DMERC form number for Motorized Wheelchairs will change 
to 02.04A

5. The Estimated Length of Need Changed for Form 843

     In Section B the estimated length of need was changed 
to ``the estimated length of need (# of months starting from the 
Initial Date in Section A).''
    Rationale: The old verbiage had physicians completing this 
section at the time they were completing the form that allowed for 
errors to occur by the physician inadvertently changing the 
estimate.
     The back page of these forms need to be revised by 
adding ``For Revised CMN or Recertification CMNs, the estimated 
length of need must be expressed as the number of months starting 
from the Initial Date in Section A.''

6. The Date of the Form Changed for Forms 841-854

     The date in the lower left corner, which indicates a 
revision without substantive changes will need to be revised to 
indicate when the changes may occur.

7. Form 843 Motorized Wheelchairs

     Change verbiage of question 7 to read, ``Is the patient 
able to operate any type of manual wheelchair.''
    Rationale: The current verbiage, which requires the physician to 
respond in the affirmative to a negative question results in 
numerous errors in completion of the form.

Proposed Changes to CMS Forms 841-854 Durable Medical Equipment 
Certificates of Medical Necessity (CMNs)

1. For Forms 841-854 the Disclosure Statement Will Change

     The address for suggestions will read, ``CMS, 7500 
Security Boulevard, N2-14-26, Baltimore, Maryland 21244-1850 and the 
Office of the Information and Regulatory Affairs, Office of 
Management and Budget, Washington, D.C. 20503.''
     The timeframe to complete the CMN will remain at 15 
minutes.

2. For Forms 841-854 the Health Care Financing Administration 
(HCFA) Would Change to Centers for Medicaid & Medicare Services 
(CMS)

     Top left of all forms will say ``U.S. Department of 
Health & Human Services, Centers for Medicaid & Medicare Services.''
     Bottom left will say ``FORM CMS__form number goes 
here.__''

3. Verbiage to the Instructions on the Back Page for HCFA Forms 
841-854

     Has been changed from ``ordering'' physician to 
``treating'' physician.

4. 5 DMERC Form Numbers Will Need Changed

     DMERC form number on the top right of the Hospital Bed 
CMN will change to 01.03A
     DMERC form number for Motorized Wheelchairs will change 
to 02.04A
     DMERC form number for Infusion Pumps will change to 
09.03
     DMERC form number for Parenteral Nutrition will change 
to 10.03A
     DMERC form number for Enteral Nutrition will change to 
10.03B

5. The Estimated Length of Need Changed for Forms 841-854

     In Section B the estimated length of need was changed 
to ``the estimated length of need (# of months starting from the 
Initial Date in Section A).''
    Rationale: The old verbiage had physicians completing this 
section at the time they were completing the form that allowed for 
errors to occur by the physician inadvertently changing the 
estimate.
     The back page of these forms need to be revised by 
adding ``For Revised CMN or Recertification CMNs, the estimated 
length of need must be expressed as the number of months starting 
from the Initial Date in Section A.''

6. The Date of the Form Changed for Forms 841-854

     The date in the lower left corner, which indicates a 
revision without substantive changes will need to be revised to 
indicate when the changes may occur.

7. Form 841 Hospital Beds

     Questions 1 and 3 of section B will be combined.
    Rationale: To simplify the questions on the form.
     Section B answer section was changed to reflect that 
question 3 is reserved for further use.

8. Form 842 Support Surfaces

     The title of the CMN would change to Air-Fluidized Beds 
and omit question 12.
    Rationale: To reflect the elimination of a CMN requirement for 
Group I and II support surfaces.
     The header in Section B needs revised to say ``Answer 
questions 13-22 for air-fluidized beds''.

9. Form 843 Motorized Wheelchairs

     Change verbiage of question 7 to read, ``Is the patient 
able to operate any type of manual wheelchair.''
    Rationale: The current verbiage, which requires the physician to 
respond in the affirmative to a negative question results in 
numerous errors in completion of the form.

10. Form 844 Manual Wheelchairs

     To be consistent with other CMNs, a box was added under 
the Section B header which says ``Questions 6 and 7 reserved for 
other or future use.''

11. Form 847 Osteogenesis Stimulators

     A box under the Section B header would be added which 
says ``Questions 1-5 reserved for other or future use''.
     The header under Section B will also be revised to say 
``Answer question 6-8 for nonspinal electrical osteogenesis 
stimulator. Answer question 9-11 for spinal electrical osteogenesis 
stimulator. Answer question 6 and 12 for ultrasonic osteogenesis 
stimulator.''
     Change verbiage of question 6a to read, `` If the 
patient has had a fracture, do two sets of multiple-view radiographs 
taken at least 90 days apart (prior to starting treatment with the 
device) show that there has been no clinically significant fracture 
healing?'' Rationale: This language is consistent with the new 
national coverage decision.
     Add question 12 which would state ``Has the patient 
failed at least one open surgical intervention for the treatment of 
the fracture?'' The answer box contains the choices ``Y N D''. 
Rationale: To accommodate ultrasonic stimulators.

12. Form 851 External Infusion Pumps

     Change the answers to question 4 to read 1 2 3 4
     Change the verbiage to question 4 to read, ``1--
Intravenous; 2--Intra-arterial; 3--Epidural; 4--Subcutaneous''
    Rationale: At least one drug for which an infusion pump is 
covered is administered intra-arterially.
     Eliminate question 5 in section B.
    Rationale: It will eliminate confusion and redundancy that is 
already captured in question 6.
     Change the verbiage of question 7 to remove the extra 
spaces between the words

[[Page 9743]]

``oral/transdermal'' and ``narcotic''
    Rationale: Correct typographical error.
     In Section B, question 7, the word ``permanent'' was 
omitted.
    Rationale: To clarify the question.
     A box would be added under the Section B Header which 
says ``Question 5 reserved for other or future use''.

13. Form 852 Parenteral Nutrition

     Change the answers to question 5 to read 1 3 4 7.
     Change the verbiage to question 5 to read, ``Circle the 
number for the route of administration. 2, 5, 6--Reserved for other 
or future use.
    1--Central Line; 3--Hemodialysis Access Line; 4--Peritoneal 
Catheter;
    7--Peripherally Inserted Catheter (PIC).''
    Rationale: Some parenteral dialysis solutions are administered 
via a beneficiary's peritoneal catheter. Use of this route of 
administration must be indicated on the CMN so that a coverage 
determination can be made accordingly.

14. Form 853 Enteral Nutrition

     Question 11 in section B would be changed to read 
``Prescribed calories per day for each product?''
    Rationale: To clarify that the number of calories ordered per 
day are not the number of calories the patient may or may not 
consume.
     Section B, question 7 the term ``permanent'' has been 
omitted.
    Rationale: The DMERC can screen for the criterion by looking at 
the value entered by the physician in the Estimated Length of Need 
field.
     Section B, question 15 will be made to a multiple-
choice question.
    Rationale: To be consistent with the policy to supply additional 
information for the use of the pump.
     Section B, answer to question 13 would be changed to 
say ``Does not apply'' in replace of ``Oral''.
    Rationale: To address situations when someone submits a CMN for 
orally administered enteral nutrients.

    However, due to the Health Insurance Portability & Accountability 
Act Administrative Simplification implications, extensive system 
changes, cost implications and time limitations needed for educational 
efforts, CMS will continue to use the current CMNs. In addition, to 
fully evaluate the impact of CMNs before making a reasoned and rational 
decision regarding the future of CMNs and the disposition of the 
proposed technical changes, CMS has contracted with Tri-Centurion, LLC 
to perform a detailed study of CMNs. Tri-Centurion is objectively 
evaluating the usage and results of CMNs and will present CMS with 
recommendations in October of 2002 that will assist in the ultimate 
disposition of each CMN.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMN's 
Web Site address at http://www.hcfa.gov/regs/prdact95.htm, 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. Written comments and 
recommendations for the proposed information collections must be mailed 
within 60 days of this notice directly to the CMS Paperwork Clearance 
Officer designated at the following address: CMS, Office of Information 
Services, Security and Standards Group, Division of CMS Enterprise 
Standards, Attention: Melissa Musotto, Room N2-14-26, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850.

    Dated: February 20, 2002.
John P. Burke III,
Reports Clearance Officer, Security and Standards Group, Division of 
CMS Enterprise Standards.
[FR Doc. 02-4971 Filed 3-1-02; 8:45 am]
BILLING CODE 4120-03-U