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(b) After the beginning of one spell of illness and before the beginning of the next;

(c) Within the 1-year period after the individual's most recent discharge from a hospital (as defined in § 405.120(a)(2)) in which he was an inpatient for at least 3 consecutive days (see § 405.120(c)), or, if later, after his most recent discharge from a skilled nursing facility in which he was an inpatient and entitled to have payment made for services furnished therein;

(d) Under a plan of treatment, established and periodically reviewed by a physician (other than a doctor of podiatry or surgical chiropody), which was established within 14 days after the date of the individual's discharge specified in paragraph (c) of this section; and

(e) By a home health agency which meets the requirements described in Subpart L of this Part 405, or by others under an arrangement with them made by such an agency; and

(f) On a visiting basis in the place of residence used as the individual's home, except that services may be furnished on an outpatient basis at a hospital, a skilled nursing facility, or certain rehabilitation centers when it is necessary to use equipment which cannot readily be made available in the individual's place of residence (see § 405.235 for further rules relating to this requirement).

[31 FR 10120, July 27, 1966, as amended at 34 FR 11205, July 3, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977]

§ 405.133 Post-hospital extended care and post-hospital home health services; presumed coverage procedure.

(a) Eligibility for presumed coverage. To qualify for extended care benefits upon admission to a skilled nursing facility a beneficiary must need 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 any of the conditions with respect to which he was receiving inpatient hospital services prior to transfer to the skilled nursing facility (see §§ 405.126

405.128(a)). To qualify for part A home health benefits upon admission to care by a home health agency following a qualifying inpatient stay a beneficiary must be confined to his home, under the care of a physician and must be in need of skilled nursing care on an intermittent basis, physical therapy or speech therapy (speech pathology) for a condition for which he received medically necessary inpatient hospital services or post-hospital extended care services. An individual who has a medical condition listed in paragraph (c) of this section (in the case of post-hospital extended care services) or paragraph (d) of this section (in the case of post-hospital home health services) is presumed to require this level of care for the period of time or number of visits specified for such condition provided:

(1) A physician submits in writing the required certification (see §§ 405.165, 405.170, 405.1632, and 405.1633) to the provider prior to or at the time of such individual's admission to a skilled nursing facility or in a timely fashion prior to the first chargeable post-hospital home health visit made to the individual;

(2) The certification indicates that the individual's medical condition is a condition set out in paragraph (c) or paragraph (d) of this section;

(3) The physician's certification is accompanied by a written plan of treatment for providing the required post-hospital extended care services or the post-hospital home health services;

(4) There is no adverse finding by the skilled nursing facility's utilization review committee or by a Professional Standards Review Organization, as appropriate, that the stay or any further stay is medically unnecessary (see §§ 405.166 and 405.1137(e) of this part and § 463.26(b)(3) of this chapter); and

(5) The Secretary has not determined for purposes of the presumed coverage provision that the physician is submitting, with some frequency, erroneous certifications or plans for providing services which are inappropriate (see paragraph (b) of this section). Where any of these requirements are not met, i.e., the physician does not submit a certification because the indi

vidual does not have a medical condition described in the regulations or the physician does not elect to certify to one of the medical conditions contained in the regulations, or one of the other requirements listed is not met, the individual is not eligible for a presumed period of coverage. However, although payment cannot be guaranteed in advance in such cases, payment under the program would nevertheless be made in such cases where the facts in the individual case establish a need for covered post-hospital extended care services or post-hospital home health services. In any case all other pertinent requirements for entitlement to post-hospital extended care or post-hospital home health benefits must be met. (See §§ 405.120 and 405.131). An individual is not eligible for more than one period of presumed coverage for each skilled nursing facility admission or admission to care by a home health agency following a qualifying inpatient stay. The periods of presumed coverage which have been established for the medical conditions designated in the regulations are not intended to encompass the entire period of care an individual may require. Individuals who require covered care beyond the presumed coverage period (or within the presumed coverage period, in the case of individuals who require additional or other home health services besides those included in the visits specified in the regulations for their medical conditions) would be eligible to have payment made for such care where the facts show in the individual case that the care needed is the type which would qualify an individual for post-hospital extended care benefits or post-hospital home health benefits. The medical conditions designated in the regulations represent an initial listing of those conditions which generally require a covered level of extended care services or home health services following hospitalization, taking into account such factors as the medical severity 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

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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 re

quested, the hearing officer's decision, described in paragraph (b)(2)(iii) cf 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.

151

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.

15

B. Closed reduction..

21

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.

15

Presumed period of covered skilled nursing

facility care (days)

Medical condition:

4. Malignancies.

Qualifying criteria: Admitted directly from hospital to skilled nursing facility for:

A. Administration of anticarcinogenic chemotherapeutic agents

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:

A. Presence of gangrene, ulceration, or unstable peripheral neuropathy...

B. Below knee amputation requiring prosthesis (amputation performed during the hospitalization immediately prior to admission to skilled nursing facility)..

C. Above knee amputation requiring prosthesis (amputation performed during the hospitalization immediately prior to admission to skilled nursing facility).

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 re

quired (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 described 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 necessi

Skilled services

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tates 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.

Presumed number of covered
home health visits

1. Skilled observation for any unstabilized condition characterized by significant Nine skilled nursing visits in a 3-week period. fluctuations in vital signs or marked edema or elevated blood sugar levels.

2. Application of dressings involving prescription medications and aseptic tech- Ten skilled nursing visits in a 2-week period. niques because of the presence of open wounds, extensive decubitus ulcers, or other widespread skin disorders.

3. A. Instructions in colostomy, ileostomy, or gastrostomy care...

B. Instructions in the routine care of an indwelling catheter..
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..

Five skilled nursing visits in a 2-week period
Three skilled nursing visits in a 2-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.

period.

G. Instruction of a patient who requires respiratory therapy in the use of Three skilled nursing visits in a 2-week special equipment such as an IPPB machine or oxygen units. H. Instruction in postural drainage procedures and pulmonary exercises......

I. Administration of anticarcinogenic chemotherapeutic agents

Three skilled nursing or three physical therapy visits in a 2-week period.

Four skilled nursing visits in a 2-week period.

Skilled services

Presumed number of covered

home health visits

4. Skilled physical therapy services and/or speech therapy (speech pathology) Five physical therapy and/or five speech services to restore functions impaired by a recent cerebrovascular accident therapy (speech pathology) visits in a 2resulting in hemiplegia and/or aphasia. 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, and amended at 44 FR 16396, Mar. 19, 1979]

§ 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 §§ 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 partici

pating 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 ren

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