[Federal Register Volume 62, Number 77 (Tuesday, April 22, 1997)]
[Notices]
[Pages 19582-19585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10490]


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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]
BILLING CODE 4120-03-P