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(1) The PSRO that originated the sanction report and the Statewide Council involved;

(2) PSROs in adjacent areas;

(3) State Medicaid fraud control units, and State licensing bodies;

(4) Hospitals, skilled nursing facilities, home health agencies, and health maintenance organizations (HMO's);

(5) Medical societies and other professional organizations; and

(6) Medicare carriers and intermediaries, health care prepayment plans, and other affected agencies and organizations.

(g) Effect of HCFA determination. (1) A practitioner or provider dissatisfied with a HCFA determination is entitled to a hearing and review by the appeals council in accordance with §§ 405.1531-405.1595 of this chapter.

(2) The HCFA determination will continue in effect unless revised by a hearing decision.

§ 474.14

Effective dates of exclusion.

(a) General provisions. Except as provided in paragraph (b) of this section:

(1) Payment will not be made under Medicare to an excluded practitioner or provider and FFP will not be available under Medicaid for services furnished by an excluded practioner or provider on or after the effective date of exclusion. (See § 455.202 of this chapter.)

(2) Assignment of a beneficiary's claim for services furnished on or after the effective date of exclusion will not be valid.

(b) Exceptions. (1) For inpatient hospital, skilled nursing facility, or intermediate care services furnished to a beneficiary or recipient who was admitted before the effective date of exclusion, payment will be available for services provided up to 30 days after that date.

(2) For home health services furnished under a plan established before the effective date of exclusion, payment will be available for services furnished through the end of the calendar year in which exclusion became effective.

(c) Denial of payment to beneficiaries. If a beneficiary submits claims for services furnished by an excluded

practitioner or provider on or after the effective date of exclusion:

(1) HCFA will pay the first claim submitted by the beneficiary and immediately give notice to the beneficiary of the exclusion; and

(2) The beneficiary's right to payment will extend to services provided up to 15 days after the date on the notice.

(d) Effective date of termination of provider agreement. For the effective date of termination of a Medicare provider agreement under § 405.614 of this chapter, see § 405.615 of this chapter.

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60-131 0-81-49

Social Security Act in accordance with section 1166 of the Act.

§ 476.2 Disclosure of public information acquired by PSROs.

(a) A PSRO shall, upon receipt of a request for specific information in its possession, provide to the person making the request a copy of that information if:

(1) The information had, prior to the request, been published or otherwise disclosed to the public by any individual

or entity other than the PSRO or its employees, members or directors, and

(2) The disclosure of the information is not prohibited by Federal or State law.

(b) A PSRO may, on its own initiative, provide to a person whom it determines to have an appropriate need for such information, a copy of any information described in paragraph (a) of this section.

(c) Information provided under this section shall be in the form in which it is received by the PSRO or in the form in which it is maintained for PSRO use.

(d) The PSRO may require the payment of a fee, for furnishing information under this section, not to exceed the reasonable cost of doing so.

§ 476.3 Disclosure of Uniform Hospital Discharge Data Set (UHDDS) acquired by a PSRO.

(a) A PSRO shall, upon receipt of a request that clearly defines the specific information desired, provide to the person making the request, summary statistics derived from the Uniform Hospital Discharge Data Set (the multi-purpose, basic data set containing information on a hospital discharge approved by the Secretary for use in Federal health programs, including the PSRO program) which does not directly or indirectly identify a particular patient or health care practitioner.

(b) A PSRO may provide to a person whom it determines to have an appropriate need for it, summary statistics acquired by the PSRO from the UHDDS which does not directly or indirectly identify a particular patient or health care practitioner.

(c) Information described in paragraphs (a) and (b) of this section, if routinely compiled for PSRO use, shall be provided without charge.

(d) The PSRO may require the payment of a fee for furnishing information under this section, not to exceed the reasonable cost of doing so.

(e) If information provided under this section identifies a particular health care institution, the PSRO shall notify the institution, at least 15 days before disclosing the information, of its intention to do so. The identified health care institution may submit to the PSRO comments concerning the information to be disclosed, which shall be attached by the PSRO to such information if received prior to its disclosure or forwarded separately by the PSRO to the recipient, if the comments are received after the information was disclosed.

(f) The PSRO may attach a statement of comment to any disclosure made under this section.

§ 476.4 Secretarial review.

Any person whose request for information is denied by the PSRO may request that the Secretary review the decision of the PSRO. If the Secretary determines that the PSRO has improperly denied the request, he shall direct the PSRO to provide the requested information and it shall do so.

PART 478-STATEWIDE PROFESSION

AL STANDARDS REVIEW COUNCILS

Subpart A-Membership Organization and Functions of Statewide Professional Standards Review Councils

Sec.
478.1 Scope.
478.2

Definitions.

478.3 Establishment and membership.
478.4 Qualifications and selection of
Statewide Council members.
478.5 Terms of office; termination of ap-
pointments; vacancies.

478.6 Duties and functions.
478.7 Organizational requirements.
478.8 Operational requirements.
478.9 Reporting requirements.
478.10 Statewide Council Agreements.

Subpart B-Advisory Groups to Statewide Professional Standards Review Councils 478.101 Scope.

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(b) Membership. The membership of a Statewide Council shall consist of: (1) One representative from each PSRO in the State;

(2) Four physician representatives; and

(3) Four persons knowledgeable in health care selected as representatives of the public in the State.

§ 478.4 Qualifications and selection of Statewide Council members.

(a) The Secretary will appoint representatives designated or nominated in accordance with this section.

(b) Designation of PSRO representatives. The Secretary will request that the governing body of each PSRO within the State designate a person who is:

(1) A member of the designating PSRO; and

(2) Willing and able to discharge the responsibilities of membership in the Statewide Council.

(c) Qualifications of physician representatives. The four physician representatives will be persons who are:

(1) Performing professional activities within the State; and

(2) Willing and able to discharge the responsibilities of membership in the Statewide Council.

(d) Designation by State medical society. (1) The Secretary will request that the membership association or organization representing the largest number of doctors of medicine in the State designate two physicians to be members of the Statewide Council.

(2) Exception. If the ratio of osteopathic physicians to total physician population in the State is equal to or greater than the ratio of osteopathic physicians to total physician population in the United States as determined by the Secretary. The Secretary will request that the membership association or organization representing the largest number of doctors of osteopathy in the State designate one physician and the membership association representing the largest number of doctors of medicine designate one physician.

(e) Designation by State hospital association. The Secretary will request that the membership association or organization representing the largest

number of hospitals in the State designate two physicians to be members of the Statewide council.

(f) Qualifications of public representatives. Each public representative shall be:

(1) Knowledgeable by education and/or experience about health care that is provided in the State under Titles V, XVII and/or XIX of the Act; (2) Willing and able to represent the interest of the public; and

(3) Willing and able to discharge the responsibilities of membership in the Statewide Council.

(g) Nomination and appointment of public representatives. Four public representatives to the Statewide Council will be nominated in the following manner and appointed by the Secretary:

(1) Nomination by the Governor of the State. The Secretary will request that the Governor of the State recommend persons qualified to be public representatives on the Statewide Council. At least two of such nominees will be appointed by the Secretary.

(2) Other nominations. The Secretary will solicit additional nominations for Statewide Council public representatives from other interested persons and organizations in the State by (i) giving notice in the FEDERAL REGISTER as well as in other publications within the State; (ii) informing those who are on a list of interested persons, and (iii) other acceptable and practicable forms of notice.

(3) Special considerations. The Governor shall, in nominating, and the Secretary will, in appointing, public representatives to the Statewide Council give special consideration to qualified individuals not affiliated with organizations and groups (i) whose representation on the Statewide Council is required by law or (ii) which are represented on the Statewide Council advisory Group.

(h) Response to Secretary's request for designations and nominations. Names of designees of PSROS, State medical societies, and State hospital associations and names of nominees from the Governor and other interested persons and organizations shall be forwarded to the Secretary within 60 days of the Secretary's official request

for such nominees, unless an extension is granted by the Secretary for cause.

§ 478.5 Terms of office; termination of appointments; vacancies.

(a) Terms. (1) Members will be appointed for initial terms of 2 or 3 years and for terms of 3 years thereafter.

(2) There will be an equal number of 2- and 3-year term positions in each of the three categories of representatives.

(3) In the case of any category containing an odd number of representatives, there will be an extra 3-year term position.

(4) Statewide Council members shall serve no more than two consecutive terms.

(b) Termination of appointments. (1) A Statewide Council member may resign his appointment at any time upon written notification to the Secretary.

(2) The Secretary may terminate the appointment of a Statewide Council member at any time for good cause.

(3) The Statewide Council may, on its own motion, recommend to the Secretary that he terminate the appointment of a member for good cause.

(4) Good cause is defined for purposes of this section as failure to continue to meet membership qualifications specified in § 478.4; serious professional and/or public misconduct; continued and substantial failure to perform the duties and functions required of Statewide Council members; and any breach of confidentiality, as defined in applicable regulations of this part.

(5) Prior to termination of a Statewide Council member for good cause, the Secretary will seek the advice and consider the recommendations of the Statewide Council.

(c) Procedures for termination for good cause. (1) Upon a determination that a Statewide Council member should be terminated for good cause, the Secretary will send written notification to the member at least 30 days prior to the effective date of the termination.

(2) The notice will set forth the grounds for the termination, afford the member the right, prior to the effective date, to submit a statement

and to request an informal meeting with an official designated by the Secretary.

(3) If no such statement or request is received prior to the effective date, the termination will be final on that date.

(4) If a request for a meeting with a designated official is timely made, the Secretary may postpone the effective date of the termination in order to enable the meeting to be held.

(5) Upon completion of the meeting, the designated official shall promptly recommend to the Secretary whether or not such termination should become effective.

(6) If the Secretary, taking into consideration any information submitted and the recommendation of the designated official, determines that good cause for termination does not exist, he will withdraw the notice of termination and notify the member of his decision.

(7) If the Secretary determines that good cause does exist, he will confirm the termination date by written notice to the member.

(d) Vacancy. When a vacancy on the Statewide Council occurs, whether by reason of expiration of membership term, death, resignation or termination, the Secretary will fill the vacancy in accordance with the applicable procedures specified in § 478.4. If a vacancy occurs for reasons other than expiration of membership term, appointment will be made for the remainder of the unexpired term.

§ 478.6 Duties and functions.

(a) Coordination of PSRO activities. Each Statewide Council shall coordinate the activities of the PSROS in its State to assure efficient PSRO operations and to support combined PSRO efforts in activities of mutual concern to the PSROS in the State. Each Statewide Council shall also assist PSROs to coordinate their activities with other health activities in the State. These coordination activities shall involve (1) identifying where cooperative efforts between or among PSROS are needed, (2) determining with the PSROS the appropriate mechanisms for coordination, and (3) assuring that the necessary support

services for implementation are provided.

(b) Dissemination of information. (1) Each Statewide Council shall disseminate information and data, with reasonable frequency and in a reasonable form, among the PSROS in its State.

(2) Dissemination may include: (i) Data and information which are available from other agencies and organizations and are relevant to PSRO operations; and (ii) data and information generated within the PSRO program, consistent with section 1166 of the Act and applicable confidentiality regulations of this part.

(3) This activity shall involve: (i) Identifying the information and data desired by PSROs; (ii) the sources of such information and data, and the appropriate methods of making such information and data available; and (iii) assuring that the necessary support services are provided so that the dissemination occurs in an effective manner.

(c) Data gathering procedures and operating procedures. Each Statewide Council shall, at the request of the Secretary or the PSROs, assist in:

(1) Developing and coordinating effective uniform PSRO data collection and processing procedures among the PSROs in the State; and

(2) Coordinating PSRO data activities in the State with other programs of the Department of Health and Human Services, including Cooperative Health Systems, Health Systems Agencies, and the programs under Titles V, XVIII, and XIX of the Act.

(d) Evaluation. Each Statewide Council shall assist the Secretary at his request in evaluating the performance of the PSROS in its State according to criteria and procedures developed by the Secretary in consultation with the Statewide Council.

(e) Replacement of a PSRO. If the Secretary finds it necessary to replace a PSRO in a State where a Statewide Council exists, the Statewide Council in such State shall assist in developing and arranging for a qualified replacement PSRO.

(f) Assistance in assuring practitioner and provider compliance. (1) Each Statewide Council shall help assure

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