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continue to receive the MCP during the period of inpatient stay.

(iv) Surgical services, including declotting of shunts, other than the insertion of catheters for patients on maintenance peritoneal dialysis who do not have indwelling catheters.

(v) Needed physician services that are

(A) Furnished by the physician furnishing renal care or by another physician;

(B) Not related to the treatment of the patient's renal condition; and

(C) Not furnished during a dialysis session or an office visit required because of the patient's renal condition.

(2) For the services described in paragraph (b)(1)(v) of this section, the following rules apply:

(i) The physician must provide documentation to show that the services are not related to the treatment of the patient's renal condition and that additional visits are required.

(ii) The carrier's medical staff, acting on the basis of the documentation and appropriate medical consultation obtained by the carrier, determines whether additional payment for the additional services is warranted.

(3) The MCP is reduced in proportion to the number of days the patient is

(i) Hospitalized and the physician elects to bill separately for services furnished during hospitalization; or

(ii) Not attended by the physician or his or her substitute for any reason, including when the physician is not available to furnish patient care or when the patient is not available to receive care.

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with the Department's established rulemaking procedures.

§ 414.316 Payment for physician services to patients in training for self-dialysis and home dialysis.

(a) For each patient, the carrier pays a flat amount that covers all physician services required to create the capacity for self-dialysis and home dialysis.

(b) HCFA determines the amount on the basis of program experience and reviews it periodically.

(c) The payment is made at the end of the training course, is subject to the deductible and coinsurance provisions, and is in addition to any amounts payable under the initial or MCP methods set forth in §§ 414.313 and 414.314, respectively.

(d) If the training is not completed, the payment amount is proportionate to the time spent in training.

§ 414.320 Determination of reasonable charges for physician renal transplantation services.

(a) Comprehensive payment for services furnished during a 60-day period. (1) The comprehensive payment is subject to the deductible and coinsurance provisions and is for all surgeon services furnished during a period of 60 days in connection with a renal transplantation, including the usual preoperative and postoperative care, and for immunosuppressant therapy if supervised by the transplant surgeon.

(2) Additional sums, in amounts established on the basis of program experience, may be included in the comprehensive payment for other surgery performed concurrently with the transplant operation.

(3) The amount of the comprehensive payment may not exceed the lower of the following:

(i) The actual charges made for the services.

(ii) Overall national payment levels established under the ESRD program and adjusted to give effect to variations in physician's charges throughout the nation. (These adjusted amounts are the maximum allowances in a carrier's service area for renal transplantation surgery and related services by surgeons.)

(4) Maximum allowances computed under these instructions are revised at the beginning of each calendar year to the extent permitted by the lesser of the following:

(i) Changes in the economic index as described in § 405.504(a)(3)(i) of this chapter.

(ii) Percentage changes in the weighted average of the carrier's prevailing charges (before adjustment by the economic index) for

(A) A unilateral nephrectomy; or

(B) Another medical or surgical service designated by HCFA for this purpose.

(b) Other payments. Payments for covered medical services furnished to the transplant recipient by other specialists, as well as for services by the transplant surgeon after the 60-day period covered by the comprehensive payment, are made under the reasonable charge criteria set forth in § 405.502 (a) through (d) of this chapter. The payments for physicians' services in connection with renal transplantations are changed on the basis of program experience and the expected advances in the medical art for this operation.

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416.60 Reimbursable services: General provision.

416.61 ASC facility services: Scope. 416.65 Covered surgical procedures. 416.75 Performance of listed surgical procedures on an inpatient hospital basis. Subpart C-Payment for Ambulatory Surgical Services

416.100 Basis and purpose. 416.110 Payment for physicians' services furnished in connection with covered surgical procedures.

416.120 Payment for facility services. 416.125 ASC facility services payment rate. 416.130 Publication of revised payment methodologies.

416.140 Reporting requirements. 416.150 Beneficiary appeals.

AUTHORITY: Secs. 1102, 1832(a)(2), 1833, 1863 and 1864 of the Social Security Act (42 U.S.C. 1302, 1395k(a)(2), 13951, 1395z and 1395aa).

SOURCE: 47 FR 34094, Aug. 5, 1982, unless otherwise noted.

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to participate as an ASC, and meets the conditions set forth in Subpart B of this part.

Covered surgical procedures means those surgical and other medical procedures which meet the criteria specified in this part and are published by HCFA in the FEDERAL REGISTER.

§ 416.3 Expenses not subject to deductible or coinsurance.

Notwithstanding any other provisions in this chapter, expenses for services covered under this part are not subject to the supplementary medical insurance benefits deductible or coinsurance requirements for

(a) Physicians' services (including pre- and post-operative services), when the physician accepts assignment as described in §§ 424.55 and 424.56 of this chapter and provides services in connection with a covered surgical procedure, as specified in § 416.65, that is performed in a participating ASC, on an outpatient basis in a hospital or in a hospital-affiliated ambulatory surgical center; or

(b) Facility services as described in § 416.61 furnished in connection with surgical procedures as specified in § 416.65 when those procedures are performed in a participating ASC.

[47 FR 34094, Aug. 5, 1982, as amended at 51 FR 41351, Nov. 14, 1986; 53 FR 6648, Mar. 2, 1988]

Subpart B-Ambulatory Surgical Centers: Coverage and Benefits

§ 416.20 Basis and purpose.

This subpart implements sections 1832(a)(2) and 1833 of the Act, with respect to

(a) The conditions that an ASC must meet to participate in the Medicare program (conditions for coverage); and (b) The scope of benefits covered in an ASC.

CONDITIONS FOR COVERAGE

§ 416.25 Basic requirements and procedures.

(a) Eligible facilities. Participation as an ASC is limited to those facilities that meet the definition in § 416.2.

(b) Survey of ASCs. (1) Unless the ASC is deemed to be in compliance

with the conditions for coverage (see § 416.39(b) for deemed compliance), the ASC must be surveyed to ascertain compliance with the requirements in §§ 416.40-416.49.

(2) HCFA will survey deemed ASCS on a sample basis as part of HCFA's validation process.

(c) Acceptance of the ASC as qualified to furnish ambulatory surgical services. If HCFA determines, after reviewing the survey agency recommendation and other evidence relating to the qualification of the ASC, that the facility meets the requirements of this subpart, it will send to the ASC—

(1) Written notice of the determination; and

(2) Two copies of the ASC agreement.

(d) Filing of agreement by the ASC. If the ASC wishes to participate in the program, it must

(1) Have both copies of the ASC agreement signed by its authorized representative; and

(2) File them with HCFA.

(e) Acceptance by HCFA. If HCFA accepts the agreement filed by the ASC, it will return to the ASC one copy of the agreement, with a notice of acceptance specifying the effective date.

(f) Appeal rights. If HCFA refuses to enter into an agreement or if HCFA terminates an agreement, the ASC is entitled to a hearing in accordance with Part 498 of this chapter.

[47 FR 34094, Aug. 5, 1982, as amended at 52 FR 22454, June 12, 1987]

§ 416.30 Terms of agreement with HCFA. As part of the agreement under § 416.25(d), the ASC must agree to the following:

(a) Compliance with coverage conditions. The ASC agrees to meet the requirements regarding conditions for coverage as specified in § 416.39 and to report promptly to HCFA any failure to do so.

(b) Charges to beneficiaries. The ASC agrees not to charge the beneficiary or any other person for items or services for which the beneficiary is entitled to have payment made under the provisions of this subpart (or for which the beneficiary would have

(4) Maximum allowances computed under these instructions are revised at the beginning of each calendar year to the extent permitted by the lesser of the following:

(i) Changes in the economic index as described in § 405.504(a)(3)(i) of this chapter.

(ii) Percentage changes in the weighted average of the carrier's prevailing charges (before adjustment by the economic index) for

(A) A unilateral nephrectomy; or

(B) Another medical or surgical service designated by HCFA for this pur

pose.

(b) Other payments. Payments for covered medical services furnished to the transplant recipient by other specialists, as well as for services by the transplant surgeon after the 60-day period covered by the comprehensive payment, are made under the reasonable charge criteria set forth in § 405.502 (a) through (d) of this chapter. The payments for physicians' services in connection with renal transplantations are changed on the basis of program experience and the expected advances in the medical art for this operation.

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Subpart C-Payment for Ambulatory Surgical Services

416.100 Basis and purpose. 416.110 Payment for physicians' services furnished in connection with covered surgical procedures.

416.120 Payment for facility services. 416.125 ASC facility services payment rate. 416.130 Publication of revised payment methodologies.

416.140 Reporting requirements. 416.150 Beneficiary appeals.

AUTHORITY: Secs. 1102, 1832(a)(2), 1833, 1863 and 1864 of the Social Security Act (42 U.S.C. 1302, 1395k(a)(2), 13951, 1395z and 1395aa).

SOURCE: 47 FR 34094, Aug. 5, 1982, unless otherwise noted.

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rticipate as an ASC, and meets onditions set forth in Subpart B 5 part.

ered surgical procedures means surgical and other medical proes which meet the criteria specin this part and are published by in the FEDERAL REGISTER.

Expenses not subject to deductible coinsurance.

withstanding any other proviin this chapter, expenses for es covered under this part are bject to the supplementary mednsurance benefits deductible or arance requirements for

Physicians' services (including nd post-operative services), when hysician accepts assignment as bed in §§ 424.55 and 424.56 of chapter and provides services in ection with a covered surgical dure, as specified in § 416.65, that formed in a participating ASC, à outpatient basis in a hospital or ospital-affiliated ambulatory surcenter; or

Facility services as described in 61 furnished in connection with cal procedures as specified in 65 when those procedures are rmed in a participating ASC.

R 34094, Aug. 5, 1982, as amended at 51 351, Nov. 14, 1986; 53 FR 6648, Mar. 2,

bpart B-Ambulatory Surgical enters: Coverage and Benefits

20 Basis and purpose.

is subpart implements sections (a)(2) and 1833 of the Act, with ect to

The conditions that an ASC must to participate in the Medicare ram (conditions for coverage); and The scope of benefits covered in SC.

CONDITIONS FOR COVERAGE

.25 Basic requirements and procelures.

Eligible facilities. Participation n ASC is limited to those facilities meet the definition in § 416.2. ) Survey of ASCs. (1) Unless the is deemed to be in compliance

with the conditions for coverage (see § 416.39(b) for deemed compliance), the ASC must be surveyed to ascertain compliance with the requirements in §§ 416.40-416.49.

(2) HCFA will survey deemed ASCs on a sample basis as part of HCFA's validation process.

(c) Acceptance of the ASC as qualified to furnish ambulatory surgical services. If HCFA determines, after reviewing the survey agency recommendation and other evidence relating to the qualification of the ASC, that the facility meets the requirements of this subpart, it will send to the ASC

(1) Written notice of the determination; and

(2) Two copies of the ASC agreement.

(d) Filing of agreement by the ASC. If the ASC wishes to participate in the program, it must

(1) Have both copies of the ASC agreement signed by its authorized representative; and

(2) File them with HCFA.

(e) Acceptance by HCFA. If HCFA accepts the agreement filed by the ASC, it will return to the ASC one copy of the agreement, with a notice of acceptance specifying the effective date.

(f) Appeal rights. If HCFA refuses to enter into an agreement or if HCFA terminates an agreement, the ASC is entitled to a hearing in accordance with Part 498 of this chapter.

[47 FR 34094, Aug. 5, 1982, as amended at 52 FR 22454, June 12, 1987]

§ 416.30 Terms of agreement with HCFA. As part of the agreement under § 416.25(d), the ASC must agree to the following:

(a) Compliance with coverage conditions. The ASC agrees to meet the requirements regarding conditions for coverage as specified in § 416.39 and to report promptly to HCFA any failure to do so.

(b) Charges to beneficiaries. The ASC agrees not to charge the beneficiary or any other person for items or services for which the beneficiary is entitled to have payment made under the provisions of this subpart (or for which the beneficiary would have

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