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Agency Information Collection Activities: Comment Request

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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.

T ype 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 Start Printed Page 9742information 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 Start Printed 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 Paperwork@hcfa.gov, 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.

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Dated: February 20, 2002.

John P. Burke III,

Reports Clearance Officer, Security and Standards Group, Division of CMS Enterprise Standards.

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[FR Doc. 02-4971 Filed 3-1-02; 8:45 am]

BILLING CODE 4120-03-U