verity of such conditions, the degree of incapacity, the type of services required and the minimum length of stay in a skilled nursing facility or the minimum period of home confinement generally needed for such conditions. These regulations will be revised periodically to include additional medical conditions which subsequent program experience indicates are the type which require covered care. (b) Unacceptable physician certifications and plans of treatment. Where the Secretary determines that a physician is submitting with some frequency: (1) Certifications that erroneously indicate that the patient's medical condition is among those listed in paragraph (c) or paragraph (d) of this section, or (2) Plans for providing services which are inappropriate and do not reflect a level of care which would qualify an individual for post-hospital extended care services or post-hospital home health services, i.e., a covered level of care (see paragraph (a) of this section), certifications and plans of treatment executed by such a physician on or after the effective date of the notice to the physician of the Secretary's final determination will not be acceptable for purposes of the presumed coverage provision. (i) Notice of proposed determination. Whenever the Secretary proposes, on the basis of appropriate evidence, to make a finding that a physician has submitted with some frequency erroneous certifications or inappropriate treatment plans, as outlined in paragraphs (b) (1) and (2) of this section, he shall give written notice to the physician of his intention not to accept the physician's certifications and treatment plans for purposes of the presumed coverage provision, and to disclose the physician's name to any provider, claimant, prospective claimant for benefits or payments, his duly authorized representative, and to other parties in interest within the provisions of Regulation No. 1 (20 CFR 401.3(w)). Such notice of the proposed determination shall be mailed to the physician's last known address. It shall state the reasons for the proposed determination and advise the physician that he may, within 30-calendar days from the mailing date of such notice of proposed determination, submit a written request for an administrative hearing; and that he may submit any pertinent evidence as to why the proposed determination should not be put into effect. The notice shall inform the physician that should he not request a hearing within the time period prescribed, the proposed determination of the Secretary shall become the final determination. (ii) Conduct of the administrative hearing. The administrative hearing shall be conducted before a hearing officer of the Health Care Financing Administration who has not had any involvement in the proposed determination. The hearing officer shall inquire fully into the matter at issue and shall receive in evidence the testimony of witnesses and any documents which are relevant and material. The physician shall be entitled to examine and question the evidence and to present and cross-examine witnesses. The physician may be represented by counsel or any other qualified representatives. (iii) Hearing officer's decision. As soon as practicable after the close of an administrative hearing, the hearing officer shall make a decision in the case which shall be based upon the evidence adduced at the hearing or otherwise included in the hearing record. The decision shall be made in writing and contain findings of fact and statement of reasons. A copy shall be mailed to the physician at his last known address. If the hearing officer determines that the proposed determination not to accept the physician's certifications and plans of treatment is correct, the hearing decision shall indicate that it shall be effective 15 days from the date of notice thereof. (iv) Notice of final determination. In those cases in which a hearing is requested, the hearing officer's decision, described in paragraph (b)(2)(iii) of this section, shall constitute the final determination of the Secretary. In those cases where no hearing is requested within the 30-day period described in paragraph (b)(2)(i) of this section, the Secretary shall send the physician final notice of the decision after the 30-day period has elapsed. The notice shall state that the determination of the Secretary is now final and that it shall be effective 15 days after the date of the notice. (v) Effect of final determination. A determination shall remain in effect until the Secretary finds that there is reasonable assurance that the reasons for his determination will not recur. (c) Medical conditions eligible for presumed coverage of post-hospital extended care services. An individual whose eligibility for post-hospital extended care services is based on one of the following medical conditions and who meets all of the requirements of paragraph (a) of this section is presumed to require on a daily basis skilled nursing care (provided directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services, which as a practical matter can only be provided in a skilled nursing facility on an inpatient basis, for the period of time specified below for each condition. Where an individual has more than one of the conditions specified below, the individual is eligible for the presumed period of coverage for the condition which presumes the longest period of coverage for extended care services. Medical condition: Presumed period of covered skilled nursing facility care (days) 1. Acute cerebrovascular accident (CVA) resulting from hemorrhage, thrombosis, embolism, brain injury, or tumor (CVA reason for qualifying hospital stay or occurred during hospital stay). Qualifying criteria: Hemiplegia and/or aphasia which requires on a daily basis skilled nursing care, physical therapy, occupational therapy, speech therapy (speech pathology), or a combination thereof-admitted directly from the hospital to skilled nursing facility. 2. Fracture of femur-neck or shaft, and/or fracture of pelvis or acetabulum. Qualifying criteria: Nonweight bearing stage following surgery or reduction, complicated by presence of infection, delayed union or aspetic necrosis; and/or a complicating secondary medical condition(s), necessitated daily skilled nursing observation and/or skilled management--admitted directly from hospital to skilled nursing facility. A. Open reduction.. B. Closed reduction.... 3. Post-arthroplasty of hip with prosthetic device (surgery performed during the hospitalization immediately prior to admission to skilled nursing facility)-admitted directly from hospital to skilled nursing facility. 4. Malignancies. Qualifying criteria: Admitted directly from hospital to skilled nursing facility for: B. Postoperative care.... C. Terminal care-Patient in terminal stage of illness and is unable to function outside of skilled nursing facility because of need for skilled management of care required on a daily basis.. 5. Diabetes Mellitus Qualifying Criteria: Admitted directly from hospital to skilled nursing facility with: 14 B. Below knee amputation requiring prosthesis (amputation performed during the hospitalization immediately prior to admission to skilled nursing facility).. 14 C. Above knee amputation requiring prosthesis (amputation performed during the hospitalization immediately prior to admission to skilled nursing facility)..... 21 6. Disease of digestive system which required colostomy, ileostomy, or gastrostomy. Qualifying criteria: Admitted directly from hospital to skilled nursing facility for: Diet control and training required (surgery performed during hospitalization immediately prior to admission to skilled nursing facility). 7. Congestive heart failure complicated by disorders of rhythm and/or requiring additional drug or anticoagulant stabilization—admitted directly from hospital to skilled nursing facility.... 8. Myocardial infarction with recurring bouts of angina and/or complicated by disorders of rhythm and/or congestive heart failure-admitted directly from hospital to skilled nursing facility 9. Chronic obstructive pulmonary disease complicated by acute respiratory infection and/or congestive heart failure-admitted directly from hospital to skilled nursing facility. (d) Medical conditions eligible for presumed coverage of post-hospital home health services. An individual whose eligibility for post-hospital home health services is based on the need for one of the skilled services de 39 scribed below for the treatment of his medical condition and who meets all of the requirements of paragraph (a) of this section is presumed to require skilled nursing care on an intermittent basis or physical therapy or speech therapy (speech pathology) for the number of home health visits designated below. The number of home health visits designated is predicated on the assumption that the length of such visits will be the usual and customary time for such visits. Where an individual's medical condition necessitates more than one of the types of skilled services specified below, and each type requires the same kind of visit, e.g., both require nursing visits, the individual is eligible for the presumed number of visits for the skilled service which presumes the largest number of home health visits. However, where each type of skilled service needed requires different kinds of visits, e.g., skilled nursing and speech therapy (speech pathology) visits, the individual is eligible for the presumed number of visits for each type of skilled services (see § 405.133(a)). The number of visits designated may be allocated in any combination so long as the visits do not exceed the total number of visits shown or the total time frame specified. Skilled services Presumed number of covered home health visits 1. Skilled observation for any unstabilized condition characterized Nine skilled nursing visits in a 3-week by significant fluctuations in vital signs or marked edema or ele- period. vated blood sugar levels. 2. Application of dressings involving prescription medications and aseptic techniques because of the presence of open wounds, extensive decubitus ulcers, or other widespread skin disorders. 3. A. Instructions in colostomy, ileostomy, or gastrostomy care.......... Ten skilled nursing visits in a 2-week period. Five skilled nursing visits in a 2-week period B. Instructions in the routine care of an indwelling catheter.... Three skilled nursing visits in a 2 C. Instruction in tube feeding technique....... D. Instruction of a newly diagnosed diabetic in a diabetic regimen, i.e., training in diet, the administration of insulin injections, urine tests, skin care, etc. E. Instruction of a recent hip fracture patient, or family members, in an exercise program and/or in the use of crutches, a walker, or a cane. F. Instruction of a recent post-arthroplasty of hip patient or a recent above or below knee amputation patient in the use of a prosthetic device.. G. Instruction of a patient who requires respiratory therapy in the use of special equipment such as an IPPB machine or oxygen units. week period Six skilled nursing visits in a 1-week period. Eight skilled nursing visits in a 3-week period Four skilled nursing or four physical therapy visits in a 2-week period Four skilled nursing or four physical therapy visits in a 2-week period. Three skilled nursing visits in a 2week period. H. Instruction in postural drainage procedures and pulmonary Three skilled nursing or three physexercises. ical therapy visits in 8 2-week period. period. of anticarcinogenic chemotherapeutic Four skilled nursing visits in a 2-week 4. Skilled physical therapy services and/or speech therapy (speech pathology) services to restore functions impaired by a recent 1 cerebrovascular accident resulting in hemiplegia and/or aphasia. Five physical therapy and/or five speech therapy (speech pathology) visits in a 2-week period. 'Recent means the medical condition was either the reason for the qualifying hospital or skilled nursing facility stay or occurred during the qualifying stay. [41 FR 21341, May 25, 1976; 41 FR 22560, June 4, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.141 Outpatient hospital diagnostic services; conditions. (a) An individual who meets the requirements set forth in § 405.102, is eligible to have payment made on his behalf to a participating hospital (or under the conditions described in §§ 405.152, 405.153, or 405.157) for outpatient hospital diagnostic services (described in § 405.145) furnished to him on or before March 31, 1968, if such items and services: (1) Are furnished during a diagnostic study (see § 405.144); (2) Are furnished to him on an outpatient basis; (3) Are furnished by the hospital or, if furnished by others under arrangements made by the hospital, are furnished in the hospital or in other facilities operated by or under the supervision of the hospital or its organized medical staff; and (4) Are of the type ordinarily furnished by the hospital (or by others under such arrangement described in paragraph (a)(3) of this section) to the hospital's outpatients for the purposes of diagnostic study. (b) Diagnostic tests and services furnished on or before March 31, 1968, may also be covered as "medical and other health services" under the supplementary medical insurance benefits plan (see Subpart B of this part) if they could not be covered under this Subpart A. [34 FR 11205, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.142 Outpatient hospital diagnostic services; deductibles. Any payment under this Subpart A for outpatient hospital diagnostic services furnished during a diagnostic study (see § 405.144) beginning before April 1, 1968, is reduced by: (a) $20; plus (b) 20 percent of the reasonable cost for such services in excess of $20. [34 FR 11205, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.144 Outpatient hospital diagnostic services; diagnostic study defined. (a) Subject to the provisions of paragraph (b) of this section, a “diagnostic study" for purposes of §§ 405.141 and 405.142 consists of the outpatient hospital diagnostic services provided by (or under arrangements made by) the same hospital during the 20-day period beginning on the first day (not included in a previous diagnostic study) on which the individual meets the requirements described in § 405.102 and on which he is furnished outpatient hospital diagnostic services. The tests and procedures furnished for the purpose of a diagnostic study need not be related to a single illness or condition. (b) All diagnostic study periods beginning on or after March 12, 1968, and before April 1, 1968, will end as of March 31, 1968, subject to the applicable deductible described in § 405.142. [34 FR 11205, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.145 Outpatient hospital diagnostic services; defined. (a) The term "outpatient hospital diagnostic services" includes diagnostic services if furnished under the conditions described in § 405.141. Services of a physician (except services of interns and residents under approved teaching programs-see § 405.522) are excluded. Also excluded are any items or services which would not be included as an "inpatient hospital service" as enumerated in § 405.116 if furnished to an inpatient of a hospital. (b) Effective with services furnished on or after April 1, 1968, coverage of outpatient hospital diagnostic services is transferred from this Subpart A to the supplementary medical insurance benefits plan described in Subpart B of this part. [34 FR 11205, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.150 Payment for services furnished; general. Amounts payable under the provisions described in this Subpart A for inpatient hospital services, posthospital extended care services, posthospital home health services or outpatient hospital diagnostic services furnished to an individual are payable, except as provided in §§ 405.152, 405.153, 405.156, and 405.157, only to a participating provider of services, that is, a provider which has entered in to an agreement with the Secretary under the conditions described in Subpart F of this Part 405. [34 FR 11206, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.151 Payment for services furnished; determination of amount payable based on reasonable cost. The amount payable to any provider (and under the provisions described in 88 405.152 and 405.153) with respect to services for which payment may be made under this Subpart A is, subject to the provisions for reducing such payment (see §§ 405.113, 405.114, 405.115, 405.123, 405.124, and 405.142), based on the reasonable cost of such services. The method of determining "reasonable cost" is discussed in Subpart D of this Part 405. [34 FR 11206, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.152 Payment for services furnished; nonparticipating hospital furnishing emergency services. (a) Payment (in amounts as determined in accordance with § 405.151) may be made to a hospital even though the hospital is not a participating provider (i.e., it has not entered into an agreement with the Secretary, pursuant to section 1866 of the Actsee § 405.606) if: (1) The hospital meets the requirements of section 1861(e) (5) and (7) of the Act (see § 405.1001(a)), and: (i) Is primarily engaged in providing under the supervision of a doctor of medicine or osteopathy the services described in section 1861(e)(1); and (ii) Is not primarily engaged in providing the services described in section 1861(j)(1)(A) (see § 405.1101(a)); (2) The services furnished are emergency services (see paragraph (b) of this section) furnished an individual who meets the requirements of § 405.102; (3) The services are furnished by the hospital or by others under an arrangement made by the hospital; (4) The hospital agrees to comply, with respect to the services furnished, with the provisions of Subpart F of this Part 405 regarding the charges for such services which may be imposed on the individual or any other person, and the return of any money incorrectly collected; (5) With respect to services furnished in a calendar year beginning after December 31, 1967, the hospital has in effect an election to claim payment for all emergency services furnished in such calendar year (see § 405.658); (6) Written request for payment is filed by, or on behalf of the individual to whom such services were furnished; (7) Payment for the services would have been made if an agreement under § 405.606 had been in effect with the hospital and the hospital otherwise met the conditions for payment; (8) The hospital's claim for payment is filed with the Health Care Financing Administration and is accompanied (attached thereto or as part thereof) by a physician's statement describing the nature of the emergency and stating that the emergency services rendered were necessary to prevent the death of the individual or the serious impairment of his health. The statement must be sufficiently comprehensive to support a finding (see § 405.191) that an emergency existed. Where the hospital files a second or subsequent claim with respect to such emergency situation, such second or subsequent claim must be accompanied by a physician's statement containing sufficient information to indicate clearly that the emergency situation still existed. When inpatient hospital services are involved, an initial or subsequent physician's statement (as appropriate) must include the date when, in the physician's judgment, the emergency ceased. (b) For purposes of the hospital insurance benefits program, "emergency services" are those inpatient hospital services (see § 405.116) and outpatient hospital diagnostic services (furnished before April 1968-see § 405.145) which are necessary to prevent the death or serious impairment of the health of the individual, and which, because of the threat to the life or health of the individual, necessitate the use of the most accessible hospital (see § 405.192) available and equipped to furnish such services. (With respect to outpatient hospital services furnished on or after April 1, 1968-see § 405.249.) [34 FR 11206, July 3, 1969, as amended at 37 FR 21163, Oct. 6, 1972. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.153 Payment for services; hospital outside the United States. (a) Emergency services. The authority contained in § 405.152 is applicable to emergency inpatient hospital services furnished an individual by a hospital located outside the United States if: |