Supporting Statement 1240-0024

SUPPORTING STATEMENT

CERTIFICATE OF MEDICAL NECESSITY (CM-893)

OMB No. 1240-0024

A. JUSTIFICATION:

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collections. Attach a copy of the appropriate section of each statute and of each regulation mandating or authorizing the collection of information.

The enabling regulations of the Black Lung Benefits Act, at 20 CFR 725.701, establish miner eligibility for medical services and supplies for the length of time required by the miner's condition and disability. 20 CFR 725.706 stipulates there must be prior approval before ordering an apparatus where the purchase price exceeds $300.00. 20 CFR 725.707 provides for the ongoing supervision of the miner's medical care, including the necessity, character and sufficiency of care to be furnished; gives the authority to request medical reports and indicates the right to refuse payment for failing to submit any report required. Because of the above legislation and regulations, it was necessary to devise a form to collect the required information. The form is the CM-893, Certificate of Medical Necessity (CMN).

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The claims examiner (CE) uses the information on the CMN to determine if the patient is eligible for black lung medical benefits if a recent hospitalization needs to be taken into account, if the medical condition is covered by the program, the length of time the item will be needed, and what durable medical equipment (DME) or outpatient service the doctor is prescribing. The CMN contains the requirements for original or certified copies of the objective test results and permits the physician to enter certain required information on the form if the information is not contained in the test report itself. The CE uses each of these items to determine if the CMN request can be approved. The DOL reimbursement standards appear on the second page of the form. The second page is also used for the doctor's signature indicating the doctor's approval and certification of the information on the CMN and shows the doctor's clinical relationship to the patient. Also, there is an area for additional medical information the doctor may wish to present in order for the CMN to be approved. The CMN is considered a medical prescription which requires pre-authorization.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The CMN data is part of the program's benefit information system. The CMN screen shows what action was taken on a requested item. By entering this data into the computer system, it allows DOL to quickly identify duplicate requests and allows the provider's bill to be processed in a consistent and timely manner. This system prevents reimbursement of unauthorized services.

The CM-893 is available for on-screen filling and/or downloading on the DCMWC web site, as mandated by the Government Paperwork Elimination Act (GPEA). The form is available at http://www.dol.gov/owcp/regs/compliance/cm-893.pdf

The CM-893 is not available for online submission because it must be accompanied by original medical test results signed by the examining physician or laboratory technician.

4. Describe efforts to identify duplication. show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

We reviewed all other information collections in DCMWC and consulted other OWCP programs. There is no duplication within the Program. Other OWCP programs have no similar requirements. This form is only used for black lung medical benefits and is unique to DCMWC.

5. If the collection information impacts small businesses or other small entities (Item 5 of 014B Form 83-1), describe any methods used to minimize burden.

Small businesses are involved because a physician is responsible for submitting the information on the CMN. We are constantly in contact with our district offices, the provider community, and our medical consultants to find ways to improve the form in order to minimize the burden. In the last several renewals of this collection, DCMWC took steps to reduce the need for the form. All current medical providers were notified by mail of changes in the billing process required by the February 2005 move to a new medical bill contractor, and DCMWC took that opportunity to enable physicians and medical service providers to check online for patient eligibility for specific services prior to completing the form.

Burden on physicians and medical suppliers was reduced by requiring the CMN only once at the beginning of each prescription for oxygen instead of annually, and by no longer requiring a CMN for certain durable medical equipment. Recertifications of the same oxygen prescription require only a letter from the physician, not a new form and test results. Thus, while the reporting burden per form was not decreased, the number of forms required over the patient’s lifetime of care has been substantially reduced.

6. Describe the consequence of Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

If the information on the CMN were not gathered, there would be no way of determining if the prescribed item or service would be appropriate in the care of the miner's pulmonary condition. Without this information and pre-authorization, the program would be subject to abuse.

For durable medical equipment, home nursing care, and pulmonary rehabilitation, the information is collected at the time a new prescription is written. We have determined that our policy of requiring less burdensome reporting for recertification of previously-approved equipment (by physician’s letter instead of the form)has not affected the patient’s receipt of necessary medical treatment or the over prescribing of unnecessary services.

7. Explain any special circumstance that would cause an information collection to be conducted in a manner:

• requiring respondents to report information to the agency more often than quarterly;

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any document;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentially that is not supported by authority established in statue or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can prove that it has instituted procedures to protect the information's confidentially to the extent permitted by law.

There are no special circumstances for conducting this information collection.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8 (d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments.

Consultation has taken place with medical consultants to DCMWC and medical staff of OWCP in an effort to simplify the form and keep the amount of required information to a minimum. A Federal Register Notice inviting public comment was published on August 30, 2011. The Agency received no comments in response to the Notice.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

Respondents do not receive gifts or payment to furnish the requested information other than remuneration for expenses and services rendered.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulations, or agency policy.

The Privacy Act System (ESA‑6 and ESA-30) provides confidentially of information collection involving a claimant's records.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary; the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

There are no questions of a sensitive nature on this form.

12. Provide estimates of the hour burden of the collection of information. The statement should:

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not make special surveys to obtain information on which to base burden estimates. Consultation with a sample of potential respondents is desirable. If the burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated burden and explain the reason for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

The estimated burden of this information collection is approximately 965 hours. This burden is based on the average number of 2,500 submissions. Approximately 340 responses involve a pulmonary function study which requires about 30 minutes to administer and calculate the results. Reading, completing and mailing the form takes another ten minutes for a total of 40 minutes (2/3 hour.)

2/3 x 340 = 227 hrs.

Approximately 2,050 responses involve an arterial blood gas study which takes about 10 minutes to administer and calculate the results. Reading, completing and mailing the form takes another 10 minutes for a total of 20 minutes (1/3 hours.)

1/3 x 2,050 = 683 hours.

The remainder of the responses, 110, involves submission of existing treatment records, requiring 20 minutes to copy and collate. Reading, completing and mailing the form takes another 10 minutes for a total of 30 minutes (1/2 hour.)

1/2 x 110 = 55 hours.

Thus, the total burden is 965 hours.

Any estimated annualized cost to respondents for providing the requested information is offset by direct payment by the Program to the respondent for the usual and customary cost for the medical tests and reports. This includes mail and handling charges.

13. Annual Costs to Respondents (capital/start-up & operation and maintenance).

There are no operational and maintenance costs associated with the collection of this information. All such costs are reimbursed.

14. Provide estimates of annualized cost to the Federal government.

The estimated total cost to the Federal Government for development, printing, mailing, and processing 2500 forms and for reimbursement to the respondents for providing the information is approximately $165,480. The cost is computed as follows:

- Printing $ 160.00

- Mailing 2,500 x .47 = $ 1,175.00

- Processing $ 50,020.00

A GS‑12/6 spends an average of 30 minutes evaluating and processing each form, and contract staff reimbursed at $17/hour spends an average of 3 minutes on clerical duties associated with each form. (The Salary Table for FY 11-RUS was used to calculate the GS-12/6 salary.)

1,250 hours x $ 38.46 = $ 48,075.00

125 hours x $ 17.00 = $ 2,125.00

- Respondent Reimbursement $115,280.00

The estimated cost to the government for reimbursement to physicians is calculated by the following (costs are derived from the maximum fee payable by DCMWC for each service):

ABG $46.00 x 2,050 = $ 94,300.00

PFS $52.00 x 340 = $ 17,680.00

Records $30.00 x 110 = $ 3,300.00

Total reimbursement = $115,280.00

Grand total cost to government = $ 165,480.00

The estimated annualized cost to the respondents for the burden hours for the collection of information including postage and envelopes at $0.47 is reimbursed to the parties by the Program. We did not include the physician’s cost with the estimate of the annualized cost to respondents for the burden hours, because any burden-hour cost to CM-893 respondents (physicians) is offset by direct payment by DCMWC to the physicians for the usual and customary cost for the necessary testing, medical records, and completing and returning the form. Physician’s office staff costs are overhead costs and are reimbursed as part of the physician’s fee.

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-I.

The total burden hours have decreased from 1,253 to 965 for a total difference of 288 burden hours. This decrease is an adjustment due to a decrease in the number of miner beneficiaries who are eligible for medical benefits.

1,253 hours in current inventory

- 965 requested burden hours

288 total decrease

While not affecting the public burden estimates, the OWCP has made some formatting changes to the information collection instrument, such as replacing a no longer used logo with the DOL seal. Such a change technically makes this request a revision.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection information, completion of report, publication dates, and other actions.

There are no plans to publish this collection of information.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

This ICR does not seek a waiver from the requirement to display the expiration date.

18. Explain each exception to the certification statement identified in Item "Certification for Paperwork Reduction Act Submissions," of OMB Form 83-I.

There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

Statistical methods are not used in these collections of information.