42 C.F.R. Subpart B—Certification and Plan of Treatment Requirements
Title 42 - Public Health
(a) Purpose. The physician has a major role in determining utilization of health services furnished by providers. The physician decides upon admissions, orders tests, drugs, and treatments, and determines the length of stay. Accordingly, sections 1814(a)(2) and 1835(a)(2) of the Act establish as a condition for Medicare payment that a physician certify the necessity of the services and, in some instances, recertify the continued need for those services. Section 1814(a)(2) of the Act also permits nurse practitioners or clinical nurse specialists to certify and recertify the need for post-hospital extended care services. (b) Scope. This subpart sets forth the timing, content, and signature requirements for certification and recertification with respect to certain Medicare services furnished by providers. [60 FR 38271, July 26, 1995] (a) Responsibility of the provider. The provider must— (1) Obtain the required certification and recertification statements; (2) Keep them on file for verification by the intermediary, if necessary; and (3) Certify, on the appropriate billing form, that the statements have been obtained and are on file. (b) Obtaining the certification and recertification statements. No specific procedures or forms are required for certification and recertification statements. The provider may adopt any method that permits verification. The certification and recertification statements may be entered on forms, notes, or records that the appropriate individual signs, or on a special separate form. Except as provided in paragraph (d) of this section for delayed certifications, there must be a separate signed statement for each certification or recertification. (c) Required information. The succeeding sections of this subpart set forth specific information required for different types of services. If that information is contained in other provider records, such as physicians' progress notes, it need not be repeated. It will suffice for the statement to indicate where the information is to be found. (d) Timeliness. (1) The succeeding sections of this subpart also specify the time frames for certifications and for initial and subsequent recertifications. (2) A hospital or SNF may provide for obtaining a certification or recertification earlier than required by these regulations, or vary the time frame (within the prescribed outer limits) for different diagnostic or clinical categories. (3) Delayed certification and recertification statements are acceptable when there is a legitimate reason for delay. (For instance, the patient was unaware of his or her entitlement when he or she was treated.) Delayed certification and recertification statements must include an explanation of the reason for the delay. (4) A delayed certification may be included with one or more recertifications on a single signed statement. (e) Limitation on authorization to sign statements. A certification or recertification statement may be signed only by one of the following: (1) A physician who is a doctor of medicine or osteopathy. (2) A dentist in the circumstances specified in §424.13(c). (3) A doctor of podiatric medicine if his or her certification is consistent with the functions he or she is authorized to perform under State law. (4) A nurse practitioner or clinical nurse specialist, as defined in paragraph (e)(5) or (e)(6) of this section, in the circumstances specified in §424.20(e). (5) For purposes of this section, to qualify as a nurse practitioner, an individual must— (i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a nurse practitioner in accordance with State law; and have a master's degree in nursing; (ii) Be certified as a nurse practitioner by a professional association recognized by CMS that has, at a minimum, eligibility requirements that meet the standards in paragraph (e)(5)(i) of this section; or (iii) Meet the requirements for a nurse practitioner set forth in paragraph (e)(5)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care. (6) For purposes of this section, to qualify as a clinical nurse specialist, an individual must— (i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a clinical nurse specialist in accordance with State law; and have a master's degree in a defined clinical area of nursing; (ii) Be certified as a clinical nurse specialist by a professional association recognized by CMS that has at a minimum, eligibility requirements that meet the standards in paragraph (e)(6)(i) of this section; or (iii) Meet the requirements for a clinical nurse specialist set forth in paragraph (e)(6)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care. [53 FR 6634, Mar. 2, 1988, as amended at 56 FR 8845, Mar. 1, 1991; 60 FR 38272, July 26, 1995] (a) Content of certification and recertification. Medicare Part A pays for inpatient hospital services of hospitals other than psychiatric hospitals only if a physician certifies and recertifies the following: (1) The reasons for either— (i) Continued hospitalization of the patient for medical treatment or medically required inpatient diagnostic study; or (ii) Special or unusual services for cost outlier cases (under the prospective payment system set forth in subpart F of part 412 of this chapter). (2) The estimated time the patient will need to remain in the hospital. (3) The plans for posthospital care, if appropriate. (b) Certification of need for hospitalization when a SNF bed is not available. (1) A physician may certify or recertify need for continued hospitalization if the physician finds that the patient could receive proper treatment in a SNF but no bed is available in a participating SNF. (2) If this is the basis for the physician's certification or recertification, the required statement must so indicate; and the physician is expected to continue efforts to place the patient in a participating SNF as soon as a bed becomes available. (c) Signatures—(1) Basic rule. Except as specified in paragraph (c)(2) of this section, certifications and recertifications must be signed by the physician responsible for the case, or by another physician who has knowledge of the case and who is authorized to do so by the responsible physician or by the hospital's medical staff. (2) Exception. If the intermediary requests certification of the need to admit a patient in connection with dental procedures, because his or her underlying medical condition and clinical status or the severity of the dental procedures require hospitalization, that certification may be signed by the dentist caring for the patient. (d) Timing of certifications and recertifications: Cases not subject to the prospective payment system (PPS). (1) For cases that are not subject to PPS, certification is required no later than as of the 12th day of hospitalization. A hospital may, at its option, provide for the certification to be made earlier, or it may vary the timing of the certification within the 12-day period by diagnostic or clinical categories. (2) The first recertification is required no later than as of the 18th day of hospitalization. (3) Subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses), but no less frequently than every 30 days. (e) Timing of certification and recertification: Cases subject to PPS. For cases subject to PPS, certification is required as follows: (1) For day-outlier cases, certification is required no later than one day after the hospital reasonably assumes that the case meets the outlier criteria, established in accordance with §412.80(a)(1)(i) of this chapter, or no later than 20 days into the hospital stay, whichever is earlier. The first and subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses) but not less frequently than every 30 days. (2) For cost-outlier cases, certification is required no later than the date on which the hospital requests cost outlier payment or 20 days into the hospital stay, whichever is earlier. If possible, certification must be made before the hospital incurs costs for which it will seek cost outlier payment. In cost outlier cases, the first and subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses). (f) Recertification requirement fulfilled by utilization review. (1) At the hospital's option, extended stay review by its UR committee may take the place of the second and subsequent physician recertifications required for cases not subject to PPS and for PPS day-outlier cases. (2) A utilization review that is used to fulfill the recertification requirement is considered timely if performed no later than the seventh day after the day the physician recertification would have been required. The next physician recertification would need to be made no later than the 30th day following such review; if review by the UR committee took the place of this physician recertification, the review could be performed as late as the seventh day following the 30th day. (g) Description of procedures. The hospital must have available on file a written description that specifies the time schedule for certifications and recertifications, and indicates whether utilization review of long-stay cases fulfills the requirement for second and subsequent recertifications of all cases not subject to PPS and of PPS day outlier cases. (a) Content of certification and recertification: General considerations. The content requirements differ from those for other hospitals because the care furnished in psychiatric hospitals is often purely custodial and thus not covered under Medicare. The purpose of the statements, therefore, is to help ensure that Medicare pays only for services of the type appropriate for Medicare coverage. Accordingly, Medicare Part A pays for inpatient care in a psychiatric hospital only if a physician certifies and recertifies the need for services consistent with the content of paragraphs (b) or (c) of this section, as appropriate. (b) Content of certification. Inpatient psychiatric services were required— (1) For treatment that could reasonably be expected to improve the patient's condition; or (2) For diagnostic study. (c) Content of recertification. (1) Inpatient services furnished since the previous certification or recertification were, and continue to be, required— (i) For treatment that could reasonably be expected to improve the patient's condition; or (ii) For diagnostic study; and (2) The hospital records show that the services furnished were— (i) Intensive treatment services; (ii) Admission and related services necessary for diagnostic study; or (iii) Equivalent services. (3) The patient continues to need, on a daily basis, active treatment furnished directly by or requiring the supervision of inpatient psychiatric facility personnel. (d) Timing of certification and recertification. (1) Certification is required at the time of admission or as soon thereafter as is reasonable and practicable. (2) The first recertification is required as of the 12th day of hospitalization. Subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses), but no less frequently than every 30 days. (e) Other requirements. Psychiatric hospitals must also meet the requirements set forth in §424.13 (b), (c), (f), and (g). [53 FR 6634, Mar. 2, 1988, as amended at 71 FR 27087, May 9, 2006; 71 FR 37504, June 30, 2006] (a) Content of certification. Medicare Part A pays for inpatient CAH services only if a physician certifies that the individual may reasonably be expected to be discharged or transferred to a hospital within 96 hours after admission to the CAH. (b) Timing of certification. Certification is required no later than 1 day before the date on which the claim for payment for the inpatient CAH services is submitted. [58 FR 30671, May 26, 1993, as amended at 60 FR 45850, Sept. 1, 1995; 62 FR 46035, 46037, Aug. 29, 1997] (a) Basic rule. If an indivdual is admitted to a hospital before becoming entitled to Medicare benefits (for instance, before attaining age 65), the day of entitlement (instead of the day of admission) is the starting point for the time limits specified in §424.13(e) for certification and recertification. (b) Example. (Hospital that is not a psychiatric hospital and is not subject to PPS). For a patient who is admitted on August 15 and becomes entitled on September 1— (1) The certification is required no later than September 12; (2) The first recertification is required no later than September 18; and (3) Subsequent recertifications are required at least every 30 days after September 18. [53 FR 6635, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] Medicare Part A pays for posthospital SNF care furnished by an SNF, or a hospital or CAH with a swing-bed approval, only if the certification and recertification for services are consistent with the content of paragraph (a) or (c) of this section, as appropriate. (a) Content of certification—(1) General requirements. Posthospital SNF care is or was required because— (i) The individual needs or needed on a daily basis skilled nursing care (furnished directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in an SNF or a swing-bed hospital on an inpatient basis, and the SNF care is or was needed for a condition for which the individual received inpatient care in a participating hospital or a qualified hospital, as defined in §409.3 of this chapter; or (ii) The individual has been correctly assigned to one of the Resource Utilization Groups designated as representing the required level of care, as provided in §409.30 of this chapter. (2) Special requirement for certifications performed prior to July 1, 2002: A swing-bed hospital with more than 49 beds (but fewer than 100) that does not transfer a swing-bed patient to a SNF within 5 days of the availability date. Transfer of the extended care patient to the SNF is not medically appropriate. (b) Timing of certification—(1) General rule. The certification must be obtained at the time of admission or as soon thereafter as is reasonable and practicable. (2) Special rules for certain swing-bed hospitals. For swing-bed hospitals with more than 49 beds that are approved after March 31, 1988, the extended care patient's physician has 5 days (excluding weekends and holidays) beginning on the availability date as defined in §413.114(b), to certify that the transfer of the extended care patient is not medically appropriate. (c) Content of recertifications. (1) The reasons for the continued need for posthopsital SNF care: (2) The estimated time the individual will need to remain in the SNF; (3) Plans for home care, if any; and (4) If appropriate, the fact that continued services are needed for a condition that arose after admission to the SNF and while the individual was still under treatment for the condition for which he or she had received inpatient hospital services. (d) Timing of recertifications. (1) The first recertification is required no later than the 14th day of posthospital SNF care. (2) Subsequent recertifications are required at least every 30 days after the first recertification. (e) Signature. Certification and recertification statements may be signed by— (1) The physician responsible for the case or, with his or her authorization, by a physician on the SNF staff or a physician who is available in case of an emergency and has knowledge of the case; or (2) A nurse practitioner or clinical nurse specialist, neither of whom has a direct or indirect employment relationship with the facility but who is working in collaboration with a physician. For purposes of this section— (i) Collaboration means a process whereby a nurse practitioner or clinical nurse specialist works with a doctor of medicine or osteopathy to deliver health care services. The services are delivered within the scope of the nurse's professional expertise, with medical direction and appropriate supervision as provided for in guidelines jointly developed by the nurse and the physician or other mechanisms defined by Federal regulations and the law of the State in which the services are performed. (ii) A direct employment relationship with the facility is one in which the nurse practitioner or clinical nurse specialist meets the common law definition of the facility's “employee,” as specified in §404.1005, §404.1007, and §404.1009 of title 20 of the regulations. When a nurse practitioner or clinical nurse specialist meets this definition with respect to an entity other than the facility itself, and that entity has an agreement with the facility for the provision of nursing services under §409.21 of this subchapter, the facility is considered to have an indirect employment relationship with the nurse practitioner or clinical nurse specialist. An indirect employment relationship does not exist if the agreement between the entity and the facility involves only the performance of delegated physician tasks under §483.40(e) of this chapter. (f) Recertification requirement fulfilled by utilization review. A SNF may substitute utilization review of extended stay cases for the second and subsequent recertifications, if it includes this procedure in its utilization review plan. (g) Description of procedures. The SNF must have available on file a written description that specifies the certification and recertification time schedule and indicates whether utilization review is used as an alternative to the second and subsequent recertifications. [53 FR 6634, Mar. 2, 1988, as amended at 54 FR 37275, Sept. 7, 1989; 58 FR 30671, May 26, 1993; 60 FR 38272, July 26, 1995; 62 FR 46037, Aug. 29, 1997; 63 FR 26311, May 12, 1998; 63 FR 53307, Oct. 5, 1998; 66 FR 39600, July 31, 2001; 70 FR 45055, Aug. 4, 2005] Medicare Part A or Part B pays for home health services only if a physician certifies and recertifies the content specified in paragraphs (a)(1) and (b)(2) of this section, as appropriate. (a) Certification—(1) Content of certification. As a condition for payment of home health services under Medicare Part A or Medicare Part B, a physician must certify as follows: (i) The individual needs or needed intermittent skilled nursing care, or physical or speech therapy, or (for the period from July through November 30, 1981) occupational therapy. (ii) Home health services were required because the individual was confined to the home except when receiving outpatient services. (iii) A plan for furnishing the services has been established and is periodically reviewed by a physician who is a doctor of medicine, osteopathy, or podiatric medicine, and who is not precluded from performing this function under paragraph (d) of this section. (A doctor of podiatric medicine may perform only plan of treatment functions that are consistent with the functions he or she is authorized to perform under State law.) (iv) The services were furnished while the individual was under the care of a physician who is a doctor of medicine, osteopathy, or podiatric medicine.1 1 As a condition of Medicare Part A payment for home health services furnished before July 1981, the physician was also required to certify that the services were needed for a condition for which the individual had received inpatient hospital or SNF services. (2) Timing and signature. The certification of need for home health services must be obtained at the time the plan of treatment is established or as soon thereafter as possible and must be signed by the physician who establishes the plan. (b) Recertification—(1) Timing and signature of recertification. Recertification is required at least every 60 days, preferably at the time the plan is reviewed, and must be signed by the physician who reviews the plan of care. The recertification is required at least every 60 days when there is a— (i) Beneficiary elected transfer; or (ii) Discharge and return to the same HHA during the 60-day episode. (2) Content and basis of recertification. The recertification statement must indicate the continuing need for services and estimate how much longer the services will be required. Need for occupational therapy may be the basis for continuing services that were initiated because the individual needed skilled nursing care or physical or speech therapy. (c) [Reserved] (d) Limitation on the performance of certification and plan of treatment functions. The need for home health services to be provided by an HHA may not be certified or recertified, and a plan of treatment may not be established and reviewed, by any physician who has a financial relationship, as defined in §411.354 of this chapter, with that HHA, unless the physician's relationship meets one of the exceptions in section 1877 of the Act, which sets forth general exceptions to the referral prohibition related to both ownership/investment and compensation; exceptions to the referral prohibition related to ownership or investment interests; and exceptions to the referral prohibition related to compensation arrangements. [53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 56 FR 8845, Mar. 1, 1991, as amended at 65 FR 41211, July 3, 2000; 66 FR 962, Jan. 4, 2001; 70 FR 70335, Nov. 21, 2005] (a) Exempted services. Certification is not required for the following: (1) Hospital services and supplies incident to physicians' services furnished to outpatients. The exemption applies to drugs and biologicals that cannot be self-administered, but not to partial hospitalization services, as set forth in paragraph (e) of this section. (2) Outpatient hospital diagnostic services, including necessary drugs and biologicals, ordinarily furnished or arranged for by a hospital for the purpose of diagnostic study. (b) General rule. Medicare Part B pays for medical and other health services furnished by providers (and not exempted under paragraph (a) of this section) only if a physician certifies the content specified in paragraph (c)(1), (c)(4) or (e)(1) of this section, as appropriate. (c) Outpatient physical therapy and speech-language pathology services—(1) Content of certification. (i) The individual needs, or needed, physical therapy or speech pathology services. (ii) The services were furnished while the individual was under the care of a physician, nurse practitioner, clinical nurse specialist, or physician assistant. (iii) The services were furnished under a plan of treatment that meets the requirements of §410.61 of this chapter. (2) Timing. The certification statement must be obtained at the time the plan of treatment is established, or as soon thereafter as possible. (3) Signature. (i) If the plan of treatment is established by a physician, nurse practitioner, clinical nurse specialist, or physician assistant, the certification must be signed by that physician or nonphysician practitioner. (ii) If the plan of treatment is established by a physical therapist or speech-language pathologist, the certification must be signed by a physician or by a nurse practitioner, clinical nurse specialist, or physician assistant who has knowledge of the case. (4) Recertification—(i) Timing. Recertification statements are required at least every 30 days and must be signed by the physician, nurse practitioner, clinical nurse specialist, or physician assistant who reviews the plan of treatment. (ii) Content. The recertification statement must indicate the continuing need for physical therapy or speech-language pathology services and an estimate of how much longer the services will be needed. (iii) Signature. Recertifications must be signed by the physician, nurse practitioner, clinical nurse specialist, or physician assistant who reviews the plan of treatment. (d) [Reserved] (e) Partial hospitalization services: Content of certification and plan of treatment requirements—(1) Content of certification. (i) The individual would require inpatient psychiatric care if the partial hospitalization services were not provided. (ii) The services are or were furnished while the individual was under the care of a physician. (iii) The services were furnished under a written plan of treatment that meets the requirements of paragraph (e)(2) of this section. (2) Plan of treatment requirements. (i) The plan is an individualized plan that is established and is periodically reviewed by a physician in consultation with appropriate staff participating in the program, and that sets forth— (A) The physician's diagnosis; (B) The type, amount, duration, and frequency of the services; and (C) The treatment goals under the plan. (ii) The physician determines the frequency and duration of the services taking into account accepted norms of medical practice and a reasonable expectation of improvement in the patient's condition. (3) Recertification requirements—(i) Signature. The physician recertification must be signed by a physician who is treating the patient and has knowledge of the patient's response to treatment. (ii) Timing. The first recertification is required as of the 18th day of partial hospitalization services. Subsequent recertifications are required at intervals established by the provider, but no less frequently than every 30 days. (iii) Content. The recertification must specify that the patient would otherwise require inpatient psychiatric care in the absence of continued stay in the partial hospitalization program and describe the following: (A) The patient's response to the therapeutic interventions provided by the partial hospitalization program. (B) The patient's psychiatric symptoms that continue to place the patient at risk of hospitalization. (C) Treatment goals for coordination of services to facilitate discharge from the partial hospitalization program. (f) All other covered medical and other health services furnished by providers—(1) Content of certification. The services were medically necessary, (2) Signature. The certificate must be signed by a physician, nurse practioner, clinical nurse specialist, or physician assistant who has knowledge of the case. (3) Timing. The physician, nurse practioner, clinical nurse specialist, or physician assistant may provide certification at the time the services are furnished or, if services are provided on a continuing basis, either at the beginning or at the end of a series of visits. (4) Recertification. Recertification of continued need for services is not required. [53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 56 FR 8845, 8853, Mar. 1, 1991; 63 FR 58912, Nov. 2, 1998; 65 FR 18548, Apr. 7, 2000] Medicare Part B pays for CORF services only if a physician certifies, and the facility physician recertifies, the content specified in paragraphs (a) and (b)(2) of this section, as appropriate. (a) Certification: Content. (1) The services were required because the individual needed skilled rehabilitation services; (2) The services were furnished while the individual was under the care of a physician; and (3) A written plan of treatment has been established and is reviewed periodically by a physician. (b) Recertification—(1) Timing. Recertification is required at least every 60 days, based on review by a facility physician who, when appropriate, consults with the professional personnel who furnish the services. (2) Content. (i) The plan is being followed; (ii) The patient is making progress in attaining the rehabilitation goals; and, (iii) The treatment is not having any harmful effect on the patient.
Title 42: Public Health
PART 424—CONDITIONS FOR MEDICARE PAYMENT
Subpart B—Certification and Plan of Treatment Requirements
§ 424.10 Purpose and scope.
§ 424.11 General procedures.
§ 424.13 Requirements for inpatient services of hospitals other than psychiatric hospitals.
§ 424.14 Requirements for inpatient services of inpatient psychiatric facilities.
§ 424.15 Requirements for inpatient CAH services.
§ 424.16 Timing of certification for individual admitted to a hospital before entitlement to Medicare benefits.
§ 424.20 Requirements for posthospital SNF care.
§ 424.22 Requirements for home health services.
§ 424.24 Requirements for medical and other health services furnished by providers under Medicare Part B.
§ 424.27 Requirements for comprehensive outpatient rehabilitation facility (CORF) services.
