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

[Document Identifier: HCFA-R-0296]

Emergency Clearance: Public Information Collection Requirements

Submitted to the Office of Management and Budget (OMB)

AGENCY: Health Care Financing Administration, HHS.

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, 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.

We are, however, requesting an emergency review of the Information

collections referenced below. In compliance with the requirement of

section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have

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

requirements for emergency review. We

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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. The Agency cannot

reasonably comply with the normal clearance procedures because public

harm is likely to result because beneficiaries may not receive timely,

accurate, complete, and useful notices which will enable them to make

informed consumer decisions, with a proper understanding of their

rights to a Medicare initial determination, their appeal rights in the

case of payment denial, and how these rights are waived if they refuse

to allow their medical information to be sent to Medicare. This

information collection standardizes the requirements set forth under 42

CFR 484.10, currently approved under OMB number 0938-0365.

HCFA is requesting OMB review and approval of this collection by

close of business 09/30/1999, with a 180-day approval period. Written

comments and recommendations will be accepted from the public if

received by the individuals designated below by close of business 9/29/

1999. During this 180-day period, we will publish a separate Federal

Register notice announcing the initiation of an extensive 60-day agency

review and public comment period on these requirements. We will submit

the requirements for OMB review and an extension of this emergency

approval.

Type of Information Collection Request: New Collection;

Title of Information Collection: Home Health Advance Beneficiary

Notices (HHABNs) and Supporting Regulations in 42 CFR 484.10;

Form No.: HCFA-R-0296 (OMB

#0938-NEW);

Use: This program memorandum (PM) is intended to instruct Home

Health Agencies (HHAs) with respect to their responsibility for

providing proper written notice to beneficiaries in advance of

furnishing what they believe to be noncovered care or of reducing or

terminating ongoing care. These new instructions and notices apply

where a physician has ordered home health care for a beneficiary but

the HHA believes that Medicare will not pay for that care. They do not

apply to situations where the physician will not order care, or where

care is reduced or terminated in accordance with a physician's order.

Medicare never pays for home health care that is not ordered by a

physician. The instructions in the PM supersede current instructions in

Medicare Intermediary Manual, Part 3 (MIM) Sec. 3730.2 and in Home

Health Agency Manual Sec. 270. These new instructions are designed to

ensure that beneficiaries receive timely, accurate, complete, and

useful notices which will enable them to make informed consumer

decisions, with a proper understanding of their rights to a Medicare

initial determination, their appeal rights in the case of payment

denial, and how these rights are waived if they refuse to allow their

medical information to be sent to Medicare. It is essential that such

notice be timely, readable and comprehensible, provide clear

directions, and provide accurate and complete information about the

services affected and the reason that Medicare denial of payment for

those services is expected by the HHA. For this reason, new notices

(the HHABNs) with very specific content and graphic design have been

prepared and are attached as Exhibits 2-4 hereto, and must be used by

all HHAs furnishing services to Medicare beneficiaries.

The model notices attached to the memorandum are designed to ensure

HHAs inform beneficiaries in writing, in a timely fashion, about

changes to their home health care, the fact that they may have to pay

for care themselves if Medicare does not pay, the process they must

follow in order to obtain an initial determination by Medicare and, if

payment is denied, to file an appeal, and the fact that they waive

those rights if they refuse to allow their medical information to be

sent to Medicare. If the HHA expects payment for the home health

services to be denied by Medicare, a beneficiary must be advised before

home health care is initiated or continued, that in the HHA's opinion,

payment probably will be required from him or her personally. These

notices must be issued by the HHA each time, and as soon as the HHA

makes the assessment that it believes Medicare payment will not be

made. The HHABNs must be provided by HHAs according to these

instructions in any case where a reduction or termination of services

is to occur, or where services are to be denied before being initiated,

except in any case in which a physician concurs in the reduction,

termination, or denial of services. Failure to do so is a violation of

the HHA Conditions of Participation in the Medicare Program, which are

currently approved PRA requirements approved under OMB number 0938-

0365, and may result in the HHA being held liable under the Limitation

on Liability (LOL) provision.

These instructions for completion, provision, and effectuation of

advance beneficiary notices by HHAs are to be used by RHHIs effective

September 30, 1999. The model notices (HHABNs) must be used by

providers and as required by the MIM, Part 3, Sec. 3440 Establishing

When Beneficiary is on Notice of Noncoverage.

Completion of Model Home Health Advance Beneficiary Notices

(HHABNs) Model Notice Exhibit 1 of the PM is for instructional purposes

only and includes guidance on the notice form. Model HHABNs, Exhibits

2-4, serve as notice to the beneficiary that the HHA believes that home

health services are not covered in different situations. HHABN-1,

Termination, is used when all home health services will be terminated.

HHABN-2, Initiation, is used when the HHA expects that Medicare will

not pay, even before services have been initiated. HHABN-3, Reduction,

is used when ongoing home health services will be reduced (e.g.,

reduced in number, frequency, or for a particular subset of services,

or otherwise). For any particular HHABN, the provider makes an original

and two copies. (If you require a copy, one more will be made.) The

provider gives, or where this is not possible mails, the original to

the beneficiary (or the person acting on his or her behalf), sends the

first copy to the beneficiary's physician, and keeps the second. When

the beneficiary (or person acting on his or her behalf) is given a

copy, he or she will return it to the provider with his or her

signature and the date he or she signed the notice. If the beneficiary

or the person acting on behalf of the beneficiary refused to sign the

HHABN, the provider's copy should be annotated accordingly, indicating

the circumstances and persons involved;

Frequency: On occasion;

Affected Public: Individuals or Households, Business or other for-

profit, Not-for-profit institutions;

Number of Respondents: 188,326;

Total Annual Responses: 360,000;

Total Annual Hours: 60,000.

To obtain copies of the supporting statement and any related forms

for the proposed paperwork collections referenced above, access HCFA's

Web Site address at http://www.hcfa.gov/regs/prdact95.htm, or E-mail

your request, including your address, phone number, to

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

1326.

Interested persons are invited to send comments regarding the

burden or any other aspect of these collections of Information

requirements. However, as noted above, comments on these Information

collection and recordkeeping requirements must be mailed and/or faxed

to the designees referenced below, by close of business 09/29/1999:

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Health Care Financing Administration, Office of Information Services,

Security and Standards Group, Division of HCFA Enterprise Standards,

Attention: Dawn Willinghan, Room N2-14-26, 7500 Security Boulevard,

Baltimore, Maryland 21244-1850.

and

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, DC

20503, Fax Number: (202) 395-6974 or (202) 395-5167, Attn: Allison

Herron Eydt, HCFA Desk Officer.

Dated: September 20, 1999.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office of Information Services,

Security and Standards Group, Division of HCFA Enterprise Standards.

[FR Doc. 99-24845 Filed 9-20-99; 2:40 pm]

BILLING CODE 4120-03-P