Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[Form # HCFA-484; OMB # 0938-0534]

Emergency Clearance: Public Information Collection Requirements

Submitted to the Office of Management and Budget (OMB)

In compliance with the requirement of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the Health Care Financing

Administration (HCFA), Department of Health and Human Services (DHHS),

has submitted to the Office of Management and Budget (OMB) the

following request for emergency review. We are requesting an emergency

review because the collection of this information is needed prior to

the expiration of the normal time limits under OMB's regulations at 5

CFR Part 1320 and public harm is likely to occur. The Oxygen

Certificate of Medical Necessity, completed by a Medicare beneficiary's

treating physician and a durable medical equipment supplier, must be

submitted to the appropriate Medicare Durable Medical Equipment

Regional Carrier before a Medicare beneficiary is deemed eligible for

home oxygen therapy and before a durable medical equipment supplier is

eligible for reimbursement. If emergency clearance is not provided,

beneficiaries may be provided vital health services in an untimely

manner or may be required to pay for oxygen services normally paid for

by the Federal government.

HCFA is requesting that after the 30-day comment period has

concluded, OMB complete its review within 7-days and provide a 180-day

approval. During this 180-day period HCFA will publish a separate

Federal Register notice announcing the initiation of a 60-day agency

review and public comment period on these requirements. Then HCFA will

submit the requirements for OMB review and an extension of this

emergency approval.

Type of Information Request: Reinstatement of a collection with a

change of a previously approved collection for which approval has

expired (OMB approval # 0938-0534); Title of Information Collection:

Attending Physician's Certification of Medical Necessity for Home

Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR

424.5; Form Number: HCFA-484; Use: To determine oxygen is reasonable

and necessary pursuant to Medicare Statute, Medicare claims for home

oxygen therapy must be supported by the treating physician's statement

and other information including estimate length of need (# of months),

diagnosis codes (ICD-9) and:

1. Results and date of the most recent arterial blood gas

PO2 and/or oxygen saturation tests.

2. The most recent arterial blood gas PO2 and/or oxygen

saturation test performed EITHER with the patient in a chronic stable

state as an outpatient, OR within two days prior to discharge from an

inpatient facility to home.

3. The most recent arterial blood gas PO2 and/or oxygen

saturation test performed at rest, during exercise, or during sleep.

4. Name and address of the physician/provider performing the most

recent arterial blood gas PO2 and/or oxygen saturation test.

5. If ordering portable oxygen, information regarding the patient's

mobility within the home.

6. Identification of the highest oxygen flow rate (in liters per

minute) prescribed.

7. If the prescribed liters per minute (LPM), as identified in item

6, are greater than 4 LPM, provide the results and date of the most

recent arterial blood gas PO2 and/or oxygen saturation test

taken on 4 LPM.

If the PO2=56-59, or the oxygen saturation=89%, then

evidence of the beneficiary meeting at least one of the following

criteria must be provided.

8. The patient having dependent edema due to congestive heart

failure.

9. The patient having cor pulmonale or pulmonary hypertension, as

documented by P pulmonale on an EKG or by an echocardiogram, gated

blood pool scan or direct pulmonary artery pressure measurement.

10. The patient having a hematocrit greater than 56%.

Form HCFA-484 obtains all pertinent information and promotes

national consistency in coverage determinations; Frequency: Other (as

needed); Affected Public: Individuals /households, business or other

for profit, and not for profit institutions; Number of Respondents:

300,000; Total Annual Responses: 300,000; Total Annual Hours Requested:

50,000.

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HCFA inadvertently excluded mention and description of revision to

HCFA-484 in Federal Register Notices announcing agency and OMB review

of the currently pending OMB submission 0938-0679, ``Durable Medical

Equipment Regional Carrier, Certificate of Medical Necessity'', Forms

HCFA-841 through HCFA-853. While all oxygen CMN related public comments

received thus far on 0938-0679 will be considered by DHHS and OMB

during this emergency approval process, public comment related to this

proposed collection are still encouraged.

To obtain copies of the supporting statement and any related forms,

E-mail your request, including your address and phone number, to

P[email protected], or call the Reports Clearance Office on (410) 786-

1326. Written comments and recommendations for the proposed information

collection HCFA-484, OMB #0938-0534, should be sent within 30 days of

this notice directly to the OMB Desk Officer designated at the

following address: OMB Human Resources and Housing Branch, Attention:

Allison Eydt, New Executive Office Building, Room 10235, Washington,

D.C. 20503.

Dated: April 17, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning Staff, Office of Financial

and Human Resources, Health Care Financing Administration.

[FR Doc. 97-10490 Filed 4-21-97; 8:45 am]

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