A request for reconsideration may be withdrawn prior to the mailing of notice of the reconsidered determination (see § 405.1516) if a written request for withdrawal is filed with the Secretary by the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility which fled the request for reconsideration and the Secretary approves the request. [41 FR 8482, Feb. 27, 1976] § 405.1514

Reconsidered determination. When a request for reconsideration has been filed as provided in § 405.1511, the Secretary shall reconsider the initial determination in question and the findings on which it was based. The Secretary shall make a reconsidered determination affirming or revising, in whole or in part. the findings and determination in question (see § 405.1515).

§ 405.1515 Submission of evidence.

The Secretary will receive in evidence any documents or written statements which are relevant and material to the matters at issue and which are submitted within a reasonable time after the filing of a request for reconsideration. The reconsidered determination will be based on the evidence considered in making the initial determination and whatever other written evidence that is submitted prior to the time of the reconsidered determination, taking into account facts relating to the status of the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility as of a date subsequent to the initial determination. [41 FR 8482, Feb. 27, 1976]

§ 405.1516 Notice of reconsidered determination.

Written notice of a reconsidered determination (see $405.1514) will be mailed to the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility concerned. The notice of the reconsidered determination will contain findings on conditions with respect to which the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility fails to meet the requirements of the law and regulations, if such be the case, and a statement of the reasons for the determination, and will inform the institution. agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility of its right to a hearing (see § 405.1530).

[41 FR 8483, Feb. 27, 1976]

§ 405.1517 Effect of reconsidered de

termination.

The reconsidered determination shall be final and binding upon the parties to the determination unless it is revised in accordance with § 405.1519 or a hearing is requested in accordance with $405.1530 and a decision rendered. § 405.1518 Extension of time to request

reconsideration.

If a party to an initial determination desires to file a request for reconsideration after the time for filing has passed (see § 405.1511(b)), such party may file a petition with the Secretary for an extension of the time. The petition shall be in writing and shall state the reasons why the request for reconsideration was not filed within the required time. For good cause shown, the Secretary may extend the time for filing a request for reconsideration.

§ 405.1519

Revision of initial or reconsidered determinations.

Except in the case of a determination that an institution, agency, or clinic qualifies as a provider of services, or that an institution qualifies to elect to claim payment for all emergency hospital services furnished in a calendar year, an initial or reconsidered determination which is otherwise final under § 405.1504 $405.1517 may be reopened by the Secretary upon its own motion within 12 months after the date of the notice of the initial determination (see § 405.1503). Notice of the reopening of a determina

or

tion and any revision thereof shall be given to the institution, agency, clinic, laboratory, portable X-ray supplier, endstage renal disease treatment facility or person which was a party to the determination (see § 405.1520).

[41 FR 8483, Feb. 27, 1976]

§ 405.1520 Notice of revision.

Written notice of the revision of an initial or reconsidered determination (see § 405.1519) will be mailed to the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility which was a party to the determination. The notice of revision will state the basis or reasons for the revised determination and, if the determination be that an independent laboratory, supplier of portable X-ray services, or end-stage renal disease treatment facility does not meet the conditions for coverage of the services subject to the determination (see Subparts M, N, and Appendix to Subpart B, of this Part 405), will contain findings on conditions with respect to which the laboratory, portable X-ray supplier, or end-stage renal disease treatment facility fails to meet the requirements of the law and regulations and will inform the laboratory, portable X-ray supplier, or end-stage renal disease treatment facility of its right to a hearing as provided in § 405.1530. [41 FR 8483, Feb. 27, 1976]

The revision of an initial or reconsidered determination (see § 405.1519) shall be final and binding upon the parties to the determination unless a request for a hearing is filed and a decision rendered. § 405.1530

Hearing: Right to hearing.

After an initial and reconsidered determination described in § 405.1502(a), (b) (1), (d) (1), and 405.1514, or after an initial determination described in § 405.1502(b) (2), (c), (d) (2), or (e); or after a revised determination described in § 405.1519, an institution, agency, clinic, laboratory, portable X-ray supplier, endstage renal disease treatment facility, or person shall be entitled to a hearing with respect to such determination, if such person or the representative of the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person files

a written request for hearing as provided in § 405.1531.

[41 FR 8483, Feb. 27, 1976]

§ 405.1531 Filing a request for a hearing; time and manner of filing.

(a) The request for a hearing shall be made in writing, signed by the person, or a proper official of the institution, agency, clinic, laboratory, portable Xray supplier, or end-stage renal disease treatment facility concerned and filed at an office of the Department of Health, Education, and Welfare, or with a presiding officer or the Appeals Council of the Bureau of Hearings and Appeals. The request must be filed within 60 days after the date notice of an initial determination provided for in § 405.1502 (b) (2), (c), (d) (2), or (e), or a reconsidered or revised determination, is received by the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person (see §§ 405.1503, 405.1516, and 405.1520), except where the time is extended for "good cause" (see § 405.1569). For purposes of this section, the date of receipt of notice of the initial, reconsidered or revised determination shall be presumed to be 5 days after the date of such notice, unless there is a reasonable showing to the contrary.

(b) The request for a hearing shall contain a statement as to the specific issues or findings of fact and conclusions of law in the preceding determination with which the institution, agency, clinic laboratory, portable X-ray supplier, endstage renal disease treatment facility, or person disagrees, and the basis for its contention that the specific issues and/or findings and conclusions were incorrect.

(c) The legal representative or any other authorized official of the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person shall be a proper person to file the request for hearing.

141 FR 8483, Feb. 27, 1976, as amended at 41 FR 47918, Nov. 1, 1976]

§ 405.1532 Parties to the hearing.

The parties to the hearing shall be the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person which was a party to the prior determination (see §§ 405.1502(b) (2), (c), (d) (2), and (e), 405.1514, and 405.1519) and the Bureau of Health Insurance (as well

as the Bureau of Quality Assurance in the case of a determination regarding an end-stage renal disease treatment facility) as representing the Secretary. The Bureau of Health Insurance (as well as the Bureau of Quality Assurance in the case of a determination regarding an end-stage renal disease treatment facility) shall be represented at the hearing (see § 405.1543).

[41 FR 8483, Feb. 27, 1976]

§ 405.1533

Administrative Law Judge.

The hearing provided for in this Subpart O shall be conducted by an Administrative Law Judge designated by the Director, Bureau of Hearings and Appeals, or his delegate. In an appropriate case, the Director or his delegate may substitute another Administrative Law Judge or designate, initially or by substitution, a member or members of the Appeals Council to conduct the hearing. The conduct of hearings shall be governed by this subpart.

§ 405.1534 Disqualification of Administrative Law Judge.

No Administrative Law Judge shall conduct a hearing in a case in which he is prejudiced or partial with respect to the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person or where he has any interest in the matter pending for decision before him. Notice of any objection which a party to the hearing may have to the Administrative Law Judge who will conduct the hearing shall be made at the earliest opportunity. The Administrative Law Judge shall consider the objection(s) and shall, in his discretion, either proceed with the hearing or withdraw. If the Administrative Law Judge withdraws, another Administrative Law Judge shall be designated (see § 405.1533) to conduct the hearing. If the Administrative Law Judge does not withdraw, the objecting party may, after the hearing, present his objections to the Appeals Council as reasons why he belives the Administrative Law Judge's decision should be revised or a new hearing held before another Administrative Law Judge.

[41 FR 8483, Feb. 27, 1976]

405.1541) the Administrative Law Judge may, in his discretion, call a prehearing conference for the purpose of delineating the issues in controversy, identifying the evidence and witnesses to be presented at the hearing, and obtaining stipulations accordingly. On the request of either party or on his own motion, the Administrative Law Judge may adjourn the prehearing conference and reconvene at a later date.

§ 405.1536 Time and place of prehearing conference.

The Administrative Law Judge shall fix a time and place for the prehearing conference, written notice of which shall be mailed to the parties not less than 10 days prior to the conference date. The notice shall inform the parties of the purpose of the prehearing conference and the issues sought to be resolved, stipulated to, or excluded. If a party has information which will involve additional issues for consideration at the prehearing conference, other than those set forth in the notice of determination (see $$ 405.1503, 405.1516, and 405.1520) and the request for hearing by the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person, timely notice should be given to the Administrative Law Judge and the other party of such information. The Administrative Law Judge may also raise any additional issues by including them in his notice of the prehearing conference or during the conference.

The prehearing conference shall be open to the person or his representative, the representatives of the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility and the representatives of the Secretary, to their technical advisors, and to such other persons as the Administrative Law Judge deems necessary or proper. The Administrative Law Judge may accept the agreement of the parties as to those facts which are not in controversy and as to questions which have been resolved favorably to the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person subsequent to the determination in dispute.

A record shall be made of all agreements and stipulations entered into at the prehearing conference. The record will be transcribed on the request of either party or the Administrative Law Judge. The Administrative Law Judge shall issue an order setting forth the results of the prehearing conference and including the agreements made by the parties as to facts not in constroversy, the matters to be considered at the hearing and the issues to be resolved. Copies of the order shall be sent to all parties. The parties shall be granted 10 days in which to file their objections to the order, following which the Administrative Law Judge shall settle the order.

§ 405.1539 Effect of prehearing confer

ence.

The agreements entered into at the prehearing conference as to issues in controversy, facts stipulated to and evidence to be presented at the hearing shall be binding on all parties unless, in the discretion of the Administrative Law Judge, facts are presented which would make the agreement unreasonable or inequitable.

§ 405.1540 Time and place of hearing.

The Administrative Law Judge shall fix a time and place for the hearing, written notice of which shall be mailed to the parties to the hearing not less than 10 days prior to the scheduled date of hearing. The notice shall inform the parties of the general and specific issues to be resolved at the hearing.

§ 405.1541 Change of time and place for hearing.

The Administrative Law Judge may change the time and place for the hearing (see § 405.1540) either on his own motion or at the request of a party for good cause shown. The Administrative Law Judge may adjourn or postpone the hearing, or he may reopen the hearing for the receipt of additional evidence at

any time prior to the mailing of notice of the decision in the case (see § 405.1557). Reasonable notice shall be given to the parties of any change in the time or place of hearing or of an adjournment or of a reopening of the hearing.

§ 405.1542 Hearing on new issues.

(a) On the application of either party, or on his own motion, the Administrative Law Judge may give notice at any time after a request for hearing has been filed (see § 405.1531), but prior to the closing of the record, that he will consider any specific new issue which may affect the rights of the institution, agency, clinic, laboratory, portable X-ray supplier, end-stage renal disease treatment facility, or person, even though the Secretary has not made an initial and reconsidered determination with respect to the issue and even though the issue arose after the request for hearing or prehearing conference. Except that, in the case of an initial determination described in § 405.1502(b) (2), (c), (d) (2), cr (e), or the Administrative Law Judge shall not consider any issue which arose on or after:

(1) The effective date of the termination of an institution's, agency's, or clinic's agreement with the Secretary, or

(2) The date on which it is determined that a laboratory, portable X-ray supplier, or end-stage renal disease treatment facility no longer meets its respective conditions for coverage of its services, or

(3) The effective date of the notification to an institution of its failure to remain in compliance with the qualifications for claiming emergency service reimbursement for a calendar year under the provisions of sections 1814(d) and 1835(b) of the Act, or (4) The effective date of the exclusion from coverage of items and services rendered by a provider or other person (see § 405.315a). Notice of the time and place of the hearing on any new issue shall, unless waived (see § 405.1550), be given to the parties within the time and manner prescribed in § 405.1540. Upon giving of such notice, the Administrative Law Judge shall, except as otherwise provided, proceed to hearing on such new issues in the same manner as he would on an issue in which an initial and reconsidered determination had been made by the Secretary and a hearing request with respect thereto had been filed.

(b) On the application of either party, or on his own motion, in lieu of considering any new issue to the manner described in the preceding paragraph, the Administrative Law Judge may remand the case for consideration of the new issue and, where appropriate, a determination. Where necessary the Administrative Le Judge may direct that the case be returned to him for further proceedings. See also § 405.1560.

[34 FR 20186, Dec. 24, 1969, as amended at 37 FR 21165, Oct. 6, 1972; 39 FR 2251, Jan. 17, 1974; 41 FR 8484, Feb. 27, 1976]

§ 405.1543 Joint hearings.

When two or more institutions, agencies, clinics, laboratories, portable X-ray suppliers, end-stage renal disease treatment facilities, or persons have requested hearings and the same or substantially similar matters are in issue, the Administration Law Judge may, if all parties agree, fix the same times and places for each prehearing conference or hearing and conduct all such proceedings jointly. Where joint hearings are held, a single record of the proceedings shall be made and a separate decision issued with respect to each institution, agency, clinic, laboratory, portable X-ray supplier, endstage renal disease treatment facility, or person.

[41 FR 8484, Feb. 27, 1976]

When reasonably necessary for the full presentation of a case, the Administrative Law Judge may upon his own motion, or upon the request of a party to the hearing, issue subpoenas for the attendance and testimory of witnesses and for the production of books, records, correspondence, papers, or other documents which are relevant and material to any matter in issue at the hearing. A party which desires the issuance of a subpoena shall, not less than 5 days prior to the time fixed for a hearing, file with the Administrative Law Judge a written request therefor, designating the witnesses or documents to be produced, and describing the address and location thereof with sufficient particularity to permit such witnesses or documents to be found. The request for a subpoena shall state the pertinent facts which the party expects to establish by such witnesses or documents and whether such facts could be established by other evidence without the "se of a subpoena. A subpoena issued under the provisions of this section shall

be issued in the name of the Secretary who shall pay the cost of the issuance and the fees and the mileage of any witnesses so subpoenaed, as provided in section 205 (d) of the Act.

[39 FR 2251, Jan. 17, 1974]

§ 405.1545 Conduct of the hearing.

The hearing shall be open to the person and his representative, the representatives of the institution, agency, clinic, laboratory, portable X-ray supplier, or end-stage renal disease treatment facility and the representatives of the Secretary, their technical advisors, and to such other persons as the Administrative Law Judge deems necessary or proper. The Administrative Law Judge shall inquire fully into all of the matters at issue (see § 405.1542) and shall receive in evidence the testimony of witnesses and any documents which are relevant and material to such matters. If the Administrative Law Judge believes that there is relevant and material evidence available which has not been presented at the hearing, the Administrative Law Judge may at any time prior to the mailing of notice of the decision, reopen the hearing for the receipt of such evidence. The order in which the evidence and the allegations shall be presented and the conduct of the hearing shall be at the discretion of the Administrative Law Judge.

[41 FR 8484, Feb. 27, 1976]

§ 405.1546 Evidence.

Evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure. The Administrative Law Judge shall rule on the admissibility of evidence.

Witnesses at the hearing shall testify under oath or affirmation. The representative of each party shall be permitted to examine his own witnesses subject to interrogation by the representative of the other party. The Administrative Law Judge may ask such questions as he deems necessary. He shall rule upon any objection made by either party as to the propriety of any question.

$ 405.1548 Oral and written summation.

The parties to a hearing shall be allowed a reasonable time for the presentation of an oral summation and for the filing of briefs or other written state