§ 461.1 Policy and applicability.

(a) Section 1152(f), of the Social Security Act (42 U.S.C. 1352(f)) provides that in the case of agreements entered into prior to January 1, 1978 under Part B of Title XI of the Social Security Act under which any organization is designated by the Secretary of Health and Human Services as the Professional Standards Review Organization for any area, the Secretary shall, prior to entering into any such agreement with any organization for any area, inform the doctors of medicine or osteopathy who are in active practice in such area of the Secre

tary's intention to enter into such an agreement with such organization.

(b) Section 1152(f) further provides that if, within a reasonable time following the service of such notice, more than 10 percentum of such doctors object to the Secretary's entering into such an agreement with such organization on the ground that such organization is not representative of doctors in such area, the Secretary shall conduct a poll of such doctors to determine whether or not such organization is representative of such doctors in such area. If more than 50 percentum of the doctors responding to such poll indicate that such organization is not representative of such doctors in such area the Secretary may not enter into such an agreement with such organization. The regulations of this part are applicable to the notification and polling by the Secretary of doctors pursuant to such section 1152(f).

(c) Notification and polling procedures under section 1152(f) shall not apply in any area designated in accordance with section 1152(a)(1) of the Act where:

(1) The membership association or organization representing the largest number of doctors of medicine in such area, or in the State in which such area is located if different, has adopted by resolution or other official procedure a formal policy position of opposition to or noncooperation with the established program of professional standards review; or

(2) The organization proposed to be designated by the Secretary under section 1152 of such Act has been negatively voted upon in accordance with the provisions of subsection (f)(2) thereof.

[39 FR 16202, May 7, 1974, as amended at 41 FR 17865, Apr. 28, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977]

(c) "Doctor" means a doctor of medicine or osteopathy engaged in the active practice of medicine or osteopathy.

§ 461.3

Determination of number of doctors in PSRO area.

For the purposes of this part, the Secretary will determine, on the basis of the latest available information which he deems appropriate for such purposes, the names, current mailing addresses, and total number of doctors in any area, designated in Part 460 of this chapter as a Professional Standards Review Organization area, with respect to which the Secretary proposes to enter into an agreement with an organization designating such organization as the Professional Standards Review Organization for such area. The information on the basis of which the total number of doctors in such area is determined by the Secretary will be available for public inspection in accordance with 5 U.S.C. 552 and 45 CFR 5.1 et seq.

[39 FR 16202, May 7, 1974, as amended at 41 FR 17865, Apr. 28, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977]

§ 461.4 Notification of doctors.

Except as provided in paragraph (c) of § 461.1, in the case of any agreement entered into prior to January 1, 1978, under Part B of Title XI of the Act, whereby any organization is designated as the Professional Standards Review Organization for any area, the Secretary, prior to entering into such agreement with any such organization, will, in accordance with the provisions of this section, notify the doctors in such area of the Secretary's intention to enter into such an agreement with such organization.

(a) Method of notice. The notice described in this section will be published in the FEDERAL REGISTER and at least one newspaper of general circulation in the Professional Standards Review Organization area. Notice in any newspaper of general circulation will be published in not less than three consecutive issues of such newspaper. In addition, copies of the notice will, not later than the date of publication in the FEDERAL REGISTER, be mailed to organizations of practicing

doctors of medicine and osteopathy, including the appropriate state and county medical and specialty societies, and hospitals and other health care facilities in the area, with a request that each such society and facility inform those doctors in its membership or on its staff who are engaged in active practice in the Professional Standards Review Organization area concerned of the contents of such notice.

(b) Content of notice. The notice required by this section will include the following:

(1) The date of publication in the FEDERAL REGISTER.

(2) A statement that the Secretary proposes to enter into an agreement with a named organization, designating such organization as the Professional Standards Review Organization for the area;

(3) A description of such organization, including its name, address, and the names of its principal officers;

(4) A statement that if any doctor in the area objects to the Secretary's entering into such an agreement with such organization on the ground that such organization is not representative of doctors in the Professional Standards Review Organization area, he may, within 30 days of the date of publication of the notice in the FEDERAL REGISTER, mail such objection in writing addressed to the Department of Health and Human Services to the mailing address set forth in the notice; and

(5) A statement that if more than 10 percentum of the number of doctors determined by the Secretary pursuant to 461.3 to be in the Professional Standards Review Organization area express timely objection as described in paragraph (b)(4) of this section (which number shall be set out in the Notice), the Secretary will conduct a poll of all such doctors in accordance with § 461.6 to determine whether or not such organization is representative of such doctors in such area.

[39 FR 16202, May 7, 1974, as amended at 41 FR 17865, Apr. 28, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977]

§ 461.5 Action by the Secretary pursuant to objections.

After the expiration of 30 days following the date of publication in the FEDERAL REGISTER of the notice described in § 461.4, the Secretary will tabulate the objections described § 461.4(b)(4) which have been received and which are postmarked prior to the end of such 30-day period. The Secretary will then 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: Either

(a) That not more than 10 per centum of the total number of doctors determined by the Secretary, pursuant to § 461.3, to be engaged in active practice of medicine or osteopathy in a Professional Standards Review Organization area have expressed timely objection, as described in § 461.4(b)(4), to the Secretary's entering into an agreement with the organization, and that the Secretary may proceed to enter into 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 § 461.3, 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 § 461.4(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 § 461.6. 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 request a ballot from the Secretary at an address specified in the notice.

§ 461.6 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 § 461.4(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 § 461.3, 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 (ii) 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

(i) 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;

(ii) 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 and Human Services 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