such agreement designating such organization as the Professional Standards Review Organization for such area; or

(b) That more than 10 per centum of the total number of doctors determined by the Secretary, pursuant to § 101.103, to be engaged in the active practice of medicine or osteopathy in a Professional Standards Review Organization area have expressed timely objection, as described in § 101.104(b) (4), to the Secretary's entering into an agreement with the organization, and that the Secretary will conduct a poll of such doctors in accordance with § 101.106. A notice published in the FEDERAL REGISTER pursuant to this paragraph will set forth the date on which such poll will be initiated, and will state that doctors in such area who have not received a ballot within 5 days after such date may reguest a ballot from the Secretary at an address specified in the notice.

§ 101.106 Polling of doctors.

(a) Conduct of poll. In any case in which the Secretary determines that more than 10 per centum of the total number of doctors in a Professional Standards Review Organization area have expressed timely objection as described in § 101.104(b) (4), to the Secretary's entering into an agreement with an organization, the Secretary will, at such time as he may select, conduct a poll of such doctors to determine whether or not such organization is representative of such doctors in such area. Such poll shall be conducted as follows: The Secretary will mail, by regular mail, to each individual doctor of medicine or osteopathy whom the Secretary determines, pursuant to § 101.103, to be engaged in the active practice of medicine or osteopathy in the Professional Standards Review Organization area, the following:

(1) A ballot in which the doctor is requested to check one of two boxes indicating that, in his opinion, the organization with which the Secretary proposes to enter into the agreement (i) is or (1) is not representative of the doctors in such area;

(2) A preaddressed postage paid envelope; and

(3) A cover letter describing the purpose of the poll, and specifically including

(1) The date of initiation of the poll, which will be not more than two days prior to the date on which the polling material is mailed;

(11) A request that the doctor complete the ballot and mail it by regular mail in the enclosed envelope;

(iii) A statement that if more than 50 per centum of the doctors responding to the poll indicate that the organization with which the Secretary proposes to enter into the agreement is not representative of the doctors in the area, the Secretary will not enter into such agreement with such organization; and

(iv) A statement that all completed ballots received which are postmarked within 30 days of the date of initiation of the poll by the Department of Health, Education, and Welfare officer, whose address appears on the enclosed envelope will be counted in determining the result of the poll.

(b) Tabulation of ballots. After the expiration of 30 days following the date of initiation of the poll as described in paragraph (a) (3) (i) of this section, the Secretary will tabulate the ballots which have been received and which are postmarked prior to the end of such 30-day period.

(1) The ballots will be tabulated in such fashion as to assure that the vote of each individual doctor responding to the poll will be secret.

(2) The tabulation proceeding will be publicly announced and will be open to the public.

(c) Retention of ballots. All ballots received by the Secretary will be retained for such period as may be necessary to assure their availability for a recount in accordance with § 101.107(c) and will be available for public inspection during such period at a place announced in the Notice published pursuant to § 101.107. § 101.107 Action by the Secretary following poll.

After tabulating the ballots received under § 101.106, the Secretary will publish a Notice in the FEDERAL REGISTER and in at least one newspaper of general circulation serving the Professional Standards Review Organization area, and will notify by letter the appropriate State and County medical societies, as follows:

(a) That not more than 50 percentum of the doctors responding to the poll indicated, by checking the appropriate box on the ballot, that the organization with which the Secretary had proposed to enter into an agreement is not representative of the doctors in the area, and that the Secretary may proceed to enter into such agreement designating such organi

zation as the Professional Standards Review Organization for such area; or

(b) That more than 50 percentum of the doctors responding to the poll indicated, by checking the appropriate box on the ballot, that the organization with which the Secretary has proposed to enter into an agreement is not representative of the doctors in the area, and accordingly that the Secretary will not enter into such an agreement with such organization; and

(c) Such count will be final, except that the Secretary will conduct a recount if at least 5 doctors in the area so request in writing, postmarked within 10 days following the date of publication of such Notice in the FEDERAL REGISTER. Such recount will be conducted in a public proceeding, and the result of the recount will be final.

Subpart N—Hearing and Appeals of Professional Standards Review Organization Determinations Interim Regulations

AUTHORITY: Section 1159 of the Social Security Act; Section 249F, Pub. L. 92-603; 86 Stat. 1429-1445 (42 U.S.C. 1320c-8); Section 1102 of the Social Security Act, 49 Stat. 647 as amended (42 U.S.C. 1302).

SOURCE: 41 FR 7878, Feb. 20, 1976, unless otherwise noted.

§ 101.1401 Applicability.

The regulations of this subpart are applicable to hearings provided by the Secretary pursuant to section 1159 (b) of the Social Security Act (hereinafter "the Act") with regard to determinations under section 1155 (a) of the Act by a PSRO, including a conditional PSRO, which has assumed full review responsibility in specified health care institutions.

§ 101.1402 Right to reconsideration, review and hearing.

(a) Any beneficiary or recipient who is entitled to benefits under the Act (other than Title V), or a provider or practitioner who is dissatisfied with a determination, with respect to a claim, made by a Professional Standards Review Organization in carrying out its responsibilities for the review of professional activities in accordance with paragraphs (1) and (2) of section 1155 (a) of the Act shall, after being notified of such determination, be entitled to a reconsideration thereof by the Professional Standards Review Organization, and, where the Professional Standards Review Organization reaffirms such determination in a State which has established a State

wide Professional Standards Review Council, and where the matter in controversy is $100 or more, such determination shall be reviewed by professional members of such Council and, if the Council so determines, revised.

(b) Where the determination of a Statewide Professional Standards Review Council is adverse to the beneficiary or recipient (or where there is no such Council in a State and where the matter in controversy is $100 or more), such beneficiary or recipient shall be entitled to a hearing thereon by the Secretary to the same extent as provided in section 205(b) of the Act.

(c) Any review or appeal provided under this section shall be in lieu of any review, hearing or appeal under the Act with respect to the same issue.

§ 101.1403 Utilization of Title XVIII, Part A, hearing procedures.

The procedures specified in §§ 405.722 (time and place of filing request for hearing), §§ 405.740 through 405.747 (determining amount in controversy), §§ 404.919 through 404.952 and 404.954 through 404.956 (procedures for conduct of hearings and Appeals Council review); §§ 405.750, 404.958, 404.961 through 404.963, and 404.966 (reopening initial or reconsidered determinations and hearings or Appeals Council decisions); and §§ 404.971 through 404.973 (representation of parties) of Title 20 Code of Federal Regulations, except to the extent inconsistent with specific provisions of this Subpart N, shall govern hearings under section 1159 (b) of the Act.

§ 101.1404 Professional consultation.

(a) Any decision made by an Administrative Law Judge with regard to a PSRO determination shall be made only after receiving and considering appropriate professional consultation on the matter.

(b) Professional consultation shall be obtained by the Administrative Law Judge, in the form of either testimony or written opinion, from an impartial medical advisor selected by the Social Security Administration in each matter which he is to decide under section 1159(b). Such consultation shall be part of the record, and shall be considered by the Administrative Law Judge along with other evidence of record in deciding the issues before him.

(1) Each party shall have the right to examine all evidence of record, including

that obtained from the medical advisor, and to present rebuttal evidence. Such rebuttal evidence shall be made part of the record for consideration.

(2) Such consultation shall be rendered by a licensed doctor of medicine or osteopathy whenever the health care services or items in question were provided or proposed to be provided by another licensed doctor of medicine or osteopathy.

(3) No professional advisor shall be utilized to provide such consultation if: (i) he was directly or indirectly involved in providing the services which are the subject of the hearing; (ii) he or any member of his family has, directly or indirectly, any financial interest in the institution in which such services were provided or were proposed to be provided; (iii) he participated in the PSRO initial or reconsidered determinations or the Statewide Council determination which is the subject of the hearing; (iv) he has staff privileges in the institution in which such services were provided or proposed to be provided; or (v) he is a member of the governing body of the PSRO or a member of the Statewide Council which rendered a determination in the matter.

§ 101.1405 Determining amount in controversy in case of proposed services. Where services or items proposed to be provided have been disapproved by the PSRO, the amount in controversy shall be determined upon the basis of reasonable estimates of the amounts which would be charged the individual if such services or items were provided, and shall be computed in accordance with the principles set forth in section 405.740 of 20 CFR.

§ 101.1406

Right to judicial review.

To the extent authorized by section 1159 (b) of the Act, a party to a decision of the Appeals Council (see section 404.950 of 20 CFR), or the decision of an Administrative Law Judge where the request for review by the Appeals Council was denied, may obtain a court review where the amount in controversy after Appeals Council review is $1,000 or more, by filing a civil action in a district court of the United States in accordance with the provisions of section 205 (g) of the Act (see § 422.210 of 20 CFR for filing procedure).

Subpart U-Membership, Organization and Functions of Advisory Groups to Professional Standards Review Organizations AUTHORITY: Secs. 1102 and 1162(e), Social Security Act (42 U.S.C. 1302, 1320c-11(e)). SOURCE: 41 FR 28687, July 12, 1976, unless otherwise noted.

§ 101.2101 Scope.

Section 1162(e) of the Social Security Act (hereinafter termed "the Act") proIvides that each Professional Standards Review Organization in any State not having a Statewide Professional Standards Review Council shall be advised and assisted in carrying out its functions by an Advisory Group. This subpart establishes the requirements for Professional Standards Review Organizations to follow in establishing and utilizing such Advisory Groups.

§ 101.2102 Membership.

(a) Composition, Terms and Qualifications. (1) Each Advisory Group shall have a minimum of seven and a maximum of eleven members.

(2) Advisory Group members shall be appointed for terms of one year. An appointed member shall not be eligible to serve more than three consecutive full terms. To the extent practicable, no more than one-half of the members of an Advisory Group shall be appointed for an initial term in any year subsequent to the first year.

(3) The membership of each Advisory Group shall consist of representatives of health care practitioners (other than physicians), of hospitals and of other health care facilities which provide within the Professional Standards Review Organization area health care services for which payment, in whole or in part, may be made under titles V, XVIII, of XIX of the Act and who are knowledgeable about the types of health care services being reviewed in the Professional Standards Review Organization area. In addition, the membership of each Advisory Group shall meet the following requirements:

(i) Representatives of health care practitioners (other than physcians). At least one-half of the members of each Advisory Group shall be representatives of health care practitioners (other than physicians). For purposes of this subpart, health care practitioners (other than physicians) are those health pro

fessionals who do not hold a Doctor of Medicine or Doctor of Osteopathy degree, meet all applicable State or Federal requirements for practice of their profession, and are actively involved in the delivery of patient care or services which are directly or indirectly paid for under titles V, XVIII and/or XIX of the Act. Each such representative shall practice his or her profession in the Professional Standards Review Organization

area.

or

(ii) Representatives of hospitals. One more members of each Advisory Group shall be representatives of hospitals. Each such representative shall be actively involved in the administration of or provision of services in a hospital which is located in the Professional Standards Review Organization area, and which has arrangements for reimbursement for services under titles V, XVIII and/or XIX of the Act.

(iii) Representatives of other health care facilities. One or more members of each Advisory Group shall be representatives of health care facilities other than hospitals. At least one such member shall be a representative of a skilled nursing facility (as defined in section 1861 (j) of the Act) or of an intermediate care facility (as defined in 45 CFR 249.10(b) (15)). Each such representative shall be actively involved in the administration of or provision of services in a health care facility other than a hospital which is located in the Professional Standards Review Organization area and which has in effect arrangements for reimbursement for services under titles V, XVIII and/or XIX of the Act.

(b) Selection procedures. (1) Each Professional Standards Review Organization in a State not having a Statewide Professional Standards Review Council shall have a standing committee, called the Advisory Group Nominating Committee, which shall solicit recommendations and nominate persons for Advisory Group membership. Each Advisory Group Nominating Committee shall have no fewer than five members and shall include at least three members of the governing body of the Professional Standards Review Organization.

(2) Each Professional Standards Review Organization shall develop a written plan for the selection of Advisory Group members. Such plan shall be submitted to the Secretary no later than 90

days after the date of execution of an agreement between the Secretary and the Professional Standards Review Organization under section 1152 (a) of the Act, and must be approved by the Secretary prior to the selection of any Advisory Group members. Such plan shall include the following provisions:

(i) Specification of the composition of the Advisory Group, including plans to rotate membership among practitioner and health care facility groups.

(ii) Specification of the organizations of health care practitioners (other than physicians), of hospitals, of other health care facilities and consumer and other interested groups from which recommendations will be sought by the Advisory Group Nominating Committee. If there are organizations comprised of practitioners or facilities within the Professional Standards Review Organization area, such organizations shall be included in those from which recommendations are sought.

(iii) Criteria and procedures for review of recommendations by the Advisory Group Nominating Committee.

(iv) Criteria and procedures for selection of Advisory Group members by the governing body of the Professional Standards Review Organization from nominations of the Advisory Group Nominating Committee.

§ 101.2103 Organizational requirements.

(a) Each Advisory Group shall establish its own organizational structure, elect its own chairperson, and develop written operating procedures, consistent with this subpart.

(b) Each Advisory Group will report directly to the governing body of the Professional Standards Review Organization.

(c) Each Advisory Group shall meet as a whole at least quarterly.

(d) Minutes shall be recorded for all Advisory Group meetings and shall be available to the public consistent, as appropriate, with applicable regulations of this Part concerning confidentiality.

(e) Each Professional Standards Review Organization shall provide its Advisory Group with staff support sufficient to enable the Advisory Group to carry out its duties and functions under this subpart.

(f) Expenses reasonably and necessarily incurred, as determined by the

Secretary, by an Advisory Group in carrying out its duties and functions under this subpart shall be considered to be expenses necessarily incurred by its Professional Standards Review

Organization.

§ 101.2104 Reporting requirements.

(a) Each Professional Standards Review Organization shall prepare annually for submission to the Secretary a report containing the following information:

(1) The Plan described in § 101.2102 (b) (2).

(2) The membership of the Advisory Group Nominating Committee.

(3) The membership of the Advisory Group.

(4) The organization of the Advisory Group.

(5) The Advisory Group's activities for the year, including the number of meetings, a description of specific projects, accomplishments, and recommendations made by the Advisory Group to its Professional Standards Review Organization.

(b) Each Advisory Group shall prepare an annual report assessing the involvement of health care practitioners (other than physicians), and of hospitals and other health care facilities in the Professional Standards Review Organization program in its Professional Standards Review Organization area. § 101.2105 Duties and functions.

(a) Each Advisory Group shall advise and assist its Professional Standards Review Organization in the performance of its functions, specifically in the follow

ing areas and in any other areas considered appropriate by the Professional Standards Review Organization:

(1) In assuring maximum effective involvement of health care practitioners (other than physicians) in the Professional Standards Review Organization activities in its Professional Standards Review Organization area.

(2) In developing effective relationships with organizations representing health care practitioners (other than physicians), hospitals and/or health care facilities within the Professional Standards Review Organization area.

(3) In carrying out the functions of the Professional Standards Review Organization under section 1160 (c) of the Act as they relate to health care practitioners (other than physicians), hospitals, and other health care facilities.

(4) In developing any modifications of the formal plan pursuant to section 1154 of the Act.

(b) An Advisory Group may undertake other activities with the approval of its Professional Standards Review Organization.

§ 101.2106 Employment nondiscrimination.

Attention is called to the requirements of Executive Order 11246 (42 U.S.C. 2000e) which prohibits discrimination against any employee or applicant for employment because of race, color, religion, sex or national origin. Regulations implementing such Executive Order 11246, which are applicable to Advisory Groups under this Subpart, have been issued by the Secretary of Labor (41 CFR Ch. 60).