42 C.F.R. Subpart A—General Provisions
Title 42 - Public Health
As used in this part— Accredited provider or supplier means a provider or supplier that has voluntarily applied for and has been accredited by a national accreditation program meeting the requirements of and approved by CMS in accordance with §488.5 or §488.6. Act means the Social Security Act. AOA stands for the American Osteopathic Association. Certification is a recommendation made by the State survey agency on the compliance of providers and suppliers with the conditions of participation, requirements (for SNFs and NFs), and conditions of coverage. Conditions for coverage means the requirements suppliers must meet to participate in the Medicare program. Conditions of participation means the requirements providers other than skilled nursing facilities must meet to participate in the Medicare program and includes conditions of certification for rural health clinics. Full review means a survey of a hospital for compliance with all conditions of participation for hospitals. JCAHO stands for the Joint Commission on Accreditation of Healthcare Organizations. Medicare condition means any condition of participation or for coverage, including any long term care requirements. Provider of services or provider means a hospital, critical access hospital, skilled nursing facility, nursing facility, home health agency, hospice, comprehensive outpatient rehabilitation facility, or provider of outpatient physical therapy or speech pathology services. Rate of disparity means the percentage of all sample validation surveys for which a State survey agency finds noncompliance with one or more Medicare conditions and no comparable condition level deficiency was cited by the accreditation organization, where it is reasonable to conclude that the deficiencies were present at the time of the accreditation organization's most recent surveys of providers or suppliers of the same type. Example: Assume that during a validation review period State survey agencies perform validation surveys at 200 facilities of the same type (for example, ambulatory surgical centers, home health agencies) accredited by the same accreditation organization. The State survey agencies find 60 of the facilities out of compliance with one or more Medicare conditions, and it is reasonable to conclude that these deficiencies were present at the time of the most recent survey by an accreditation organization. The accreditation organization, however, has found deficiencies comparable to the condition level deficiencies at only 22 of the 60 facilities. These validation results would yield ((60–22)/200) a rate of disparity of 19 percent. Reasonable assurance means that an accreditation organization has demonstrated to CMS's satisfaction that its requirements, taken as a whole, are at least as stringent as those established by CMS, taken as a whole. State includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa. State survey agency means the State health agency or other appropriate State or local agency used by HFCA to perform survey and review functions for Medicare. Substantial allegation of noncompliance means a complaint from any of a variety of sources (including complaints submitted in person, by telephone, through written correspondence, or in newspaper or magazine articles) that, if substantiated, would affect the health and safety of patients and raises doubts as to a provider's or supplier's noncompliance with any Medicare condition. Supplier means any of the following: Independent laboratory; portable X-ray services physical therapist in independent practice; ESRD facility; rural health clinic; Federally qualified health center; or chiropractor. Validation review period means the one year period during which CMS conducts a review of the validation surveys and evaluates the results of the most recent surveys performed by the accreditation organization. [53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991; 57 FR 24982, June 12, 1992; 58 FR 30676, May 26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997] This part is based on the indicated provisions of the following sections of the Act:
1128—Exclusion of entities from participation in Medicare. 1128A—Civil money penalties. 1814—Conditions for, and limitations on, payment for Part A services. 1819—Requirements for SNFs. 1861(f)—Requirements for psychiatric hospitals. 1861(z)—Institutional planning standards that hospitals and SNFs must meet. 1861(ee)—Discharge planning guidelines for hospitals. 1861(ss)(2)—Accreditation of religious nonmedical health care institutions. 1864—Use of State survey agencies. 1865—Effect of accreditation. 1880—Requirements for hospitals and SNFs of the Indian Health Service. 1883—Requirements for hospitals that provide SNF care. 1902—Requirements for participation in the Medicaid program. 1913—Medicaid requirements for hospitals that provide NF care. 1919—Medicaid requirements for NFs. [60 FR 50443, Sept. 29, 1995, as amended at 64 FR 67052, Nov. 30, 1999] (a) Basic rules. In order to be approved for participation in or coverage under the Medicare program, a prospective provider or supplier must: (1) Meet the applicable statutory definition in section 1138(b), 1819, 1832(a)(2)(F), 1861, 1881, or 1919 of the Act; and (2) Be in compliance with the applicable conditions or long-term care requirements prescribed in subpart N, Q or U of part 405, part 416, subpart C of part 418, part 482, part 483, part 484, part 485, subpart A of part 491, or part 494 of this chapter. (b) Special Conditions. (1) The Secretary, after consultation with the JCAHO or AOA, may issue conditions of participation for hospitals higher or more precise than those of either those accrediting bodies. (2) The Secretary may, at a State's request, approve health and safety requirements for providers and suppliers in that State, which are higher than those otherwise applied in the Medicare program. (3) If a State or political subdivision imposes higher requirements on institutions as a condition for the purchase of health services under a State Medicaid Plan approved under Title XIX of the Act, (or if Guam, Puerto Rico, or the Virgin Islands does so under a State plan for Old Age Assistance under Title I of the Act, or for Aid to the Aged, Blind, and Disabled under the original Title XVI of the Act), the Secretary is required to impose similar requirements as a condition for payment under Medicare in that State or political subdivision. [53 FR 22859, June 17, 1988, as amended at 58 FR 61838, Nov. 23, 1993] (a) A national accreditation organization applying for approval of deeming authority for Medicare requirements under §488.5 or 488.6 of this subpart must furnish to CMS the information and materials specified in paragraphs (a)(1) through (10) of this section. A national accreditation organization reapplying for approval must furnish to CMS whatever information and materials from paragraphs (a)(1) through (10) of this section that CMS requests. The materials and information are— (1) The types of providers and suppliers for which the organization is requesting approval; (2) A detailed comparison of the organization's accreditation requirements and standards with the applicable Medicare requirements (for example, a crosswalk); (3) A detailed description of the organization's survey process, including— (i) Frequency of the surveys performed; (ii) Copies of the organization's survey forms, guidelines and instructions to surveyors; (iii) Accreditation survey review process and the accreditation status decision-making process; (iv) Procedures used to notify accredited facilities of deficiencies and the procedures used to monitor the correction of deficiencies in accredited facilities; and (v) Whether surveys are announced or unannounced; (4) Detailed information about the individuals who perform surveys for the accreditation organization, including— (i) The size and composition of accreditation survey teams for each type of provider and supplier accredited; (ii) The education and experience requirements surveyors must meet; (iii) The content and frequency of the in-service training provided to survey personnel; (iv) The evaluation systems used to monitor the performance of individual surveyors and survey teams; and (v) Policies and procedures with respect to an individual's participation in the survey or accreditation decision process of any facility with which the individual is professionally or financially affiliated; (5) A description of the organization's data management and analysis system with respect to its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system; (6) The organization's procedures for responding to and for the investigation of complaints against accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies and ombudsmen programs; (7) The organization's policies and procedures with respect to the withholding or removal of accreditation status for facilities that fail to meet the accreditation organization's standards or requirements, and other actions taken by the organization in response to noncompliance with its standards and requirements; (8) A description of all types (for example, full, partial, type of facility, etc.) and categories (provisional, conditional, temporary, etc.) of accreditation offered by the organization, the duration of each type and category of accreditation and a statement specifying the types and categories of accreditation for which approval of deeming authority is sought; (9) A list of all currently accredited facilities, the type and category of accreditation currently held by each facility, and the expiration date of each facility's current accreditation; and (10) A list of all full and partial accreditation surveys scheduled to be performed by the organization. (b) The accreditation organization must also submit the following supporting documentation— (1) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data in ASCII comparable code; (2) A resource analysis that demonstrates that the organization's staffing, funding and other resources are adequate to perform the required surveys and related activities; and (3) A statement acknowledging that as a condition for approval of deeming authority, the organization will agree to— (i) Notify CMS in writing of any facility that has had its accreditation revoked, withdrawn, or revised, or that has had any other remedial or adverse action taken against it by the accreditation organization within 30 days of any such action taken; (ii) Notify all accredited facilities within 10 days of CMS's withdrawal of the organization's approval of deeming authority; (iii) Notify CMS in writing at least 30 days in advance of the effective date of any proposed changes in accreditation requirements; (iv) Within 30 days of a change in CMS requirements, submit to CMS an acknowledgement of CMS's notification of the change as well as a revised crosswalk reflecting the new requirements and inform CMS about how the organization plans to alter its requirements to conform to CMS's new requirements; (v) Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings; (vi) [Reserved] (vii) Notify CMS in writing within ten days of a deficiency identified in any accreditation entity where the deficiency poses an immediate jeopardy to the entity's patients or residents or a hazard to the general public; and (viii) Conform accreditation requirements to changes in Medicare requirements. (c) If CMS determines that additional information is necessary to make a determination for approval or denial of the accreditation organization's application for deeming authority, the organization will be notified and afforded an opportunity to provide the additional information. (d) CMS may visit the organization's offices to verify representations made by the organization in its application, including, but not limited to, review of documents and interviews with the organization's staff. (e) The accreditation organization will receive a formal notice from CMS stating whether the request for deeming authority has been approved or denied, the rationale for any denial, and reconsideration and reapplication procedures. (f) An accreditation organization may withdraw its application for approval of deeming authority at any time before the formal notice provided for in paragraph (e) of this section is received. (g) Except as provided in paragraph (i) of this section, an accreditation organization that has been notified that its request for deeming authority has been denied may request a reconsideration of that determination in accordance with subpart D of this part. (h) Except as provided in paragraph (i) of this section, any accreditation organization whose request for approval of deeming authority has been denied may resubmit its application if the organization— (1) Has revised its accreditation program to address the rationale for denial of its previous request; (2) Can demonstrate that it can provide reasonable assurance that its accredited facilities meet applicable Medicare requirements; and (3) Resubmits the application in its entirety. (i) If an accreditation organization has requested, in accordance with part 488, subpart D of this chapter, a reconsideration of CMS's determination that its request for deeming approval is denied, it may not submit a new application for deeming authority for the type of provider or supplier that is at issue in the reconsideration until the reconsideration is administratively final. [58 FR 61838, Nov. 23, 1993] (a) Deemed to meet. Institutions accredited as hospitals by the JCAHO or AOA are deemed to meet all of the Medicare conditions of participation for hospitals, except— (1) The requirement for utilization review as specified in section 1861(e)(6) of the Act and in §482.30 of this chapter; (2) The additional special staffing and medical records requirements that are considered necessary for the provision of active treatment in psychiatric hospitals (section 1861(f) of the Act) and implementing regulations; and (3) Any requirements under section 1861(e) of the Act and implementing regulations that CMS, after consulting with JCAHO or AOA, identifies as being higher or more precise than the requirements for accreditation (section 1865(a)(4) of the Act). (b) Deemed status for providers and suppliers that participate in the Medicaid program. Eligibility for Medicaid participation can be established through Medicare deemed status for providers and suppliers that are not required under Medicaid regulations to comply with any requirements other than Medicare participation requirements for that provider r supplier type. (c) Release and use of hospital accreditation surveys. (1) A hospital deemed to meet program requirements must authorize its accreditation organization to release to CMS and the State survey agency a copy of its most current accreditation survey together with any other information related to the survey that CMS may require (including corrective action plans). (2) CMS may use a validation survey, an accreditation survey or other information related to the survey to determine that a hospital does not meet the Medicare conditions of participation. (3) CMS may disclose the survey and information related to the survey to the extent that the accreditation survey and related survey information are related to an enforcement action taken by CMS. [58 FR 61840, Nov. 23, 1993] (a) In accordance with the requirements of this subpart, a national accreditation program for hospitals; psychiatric hospitals; SNFs; HHAs; ASCs; RHCs; CORFs; hospices; religious nonmedical health care institutions; screening mammography services; critical access hospitals; or clinic, rehabilitation agency, or public health agency providers of outpatient physical therapy, occupational therapy or speech pathology services may provide reasonable assurance to CMS that it requires the providers or suppliers it accredits to meet requirements that are at least as stringent as the Medicare conditions when taken as a whole. In such a case, CMS may deem the providers or suppliers the program accredits to be in compliance with the appropriate Medicare conditions. These providers and suppliers are subject to validation surveys under §488.7 of this subpart. CMS will publish notices in the (b) Eligibility for Medicaid participation can be established through Medicare deemed status for providers and suppliers that are not required under Medicaid regulations to comply with any requirements other than Medicare participation requirements for that provider or supplier type. (c)(1) A provider or supplier deemed to meet program requirements under paragraph (a) of this section must authorize its accreditation organization to release to CMS and the State survey agency a copy of its most current accreditation survey, together with any information related to the survey that CMS may require (including corrective action plans). (2) CMS may determine that a provider or supplier does not meet the Medicare conditions on the basis of its own investigation of the accreditation survey or any other information related to the survey. (3) Upon written request, CMS may disclose the survey and information related to the survey— (i) Of any HHA; or (ii) Of any other provider or supplier specified at paragraph (a) of this section if the accreditation survey and related survey information relate to an enforcement action taken by CMS. [58 FR 61840, Nov. 23, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64 FR 67052, Nov. 30, 1999] (a) Basis for survey. CMS may require a survey of an accredited provider or supplier to validate its organization's accreditation process. These surveys will be conducted on a representative sample basis, or in response to substantial allegations of noncompliance. (1) When conducted on a representative sample basis, the survey is comprehensive and addresses all Medicare conditions or is focused on a specific condition or conditions. (2) When conducted in response to a substantial allegation, the State survey agency surveys for any condition that CMS determines is related to the allegations. (3) If the State survey agency substantiates a deficiency and CMS determines that the provider or supplier is out of compliance with any Medicare condition, the State survey agency conducts a full Medicare survey. (b) Effect of selection for survey. A provider or supplier selected for a validation survey must— (1) Authorize the validation survey to take place; and (2) Authorize the State survey agency to monitor the correction of any deficiencies found through the validation survey. (c) Refusal to cooperate with survey. If a provider or supplier selected for a validation survey fails to comply with the requirements specified in paragraph (b) of this section, it will no longer be deemed to meet the Medicare conditions but will be subject to full review by the State survey agency in accordance with §488.11 and may be subject to termination of its provider agreement under §489.53 of this chapter. (d) Consequences of finding of noncompliance. If a validation survey results in a finding that the provider or supplier is out of compliance with one or more Medicare conditions, the provider or supplier will no longer be deemed to meet any Medicare conditions. Specifically, the provider or supplier will be subject to the participation and enforcement requirements applied to all providers or suppliers that are found out of compliance following a State agency survey under §488.24 and to full review by a State agency survey in accordance with §488.11 and may be subject to termination of the provider agreement under §439.53 of this chapter and any other applicable intermediate sanctions and remedies. (e) Reinstating effect of accreditation. An accredited provider or supplier will again be deemed to meet the Medicare conditions in accordance with this section if— (1) It withdraws any prior refusal to authorize its accreditation organization to release a copy of the provider's or supplier's current accreditation survey; (2) It withdraws any prior refusal to allow a validation survey; and (3) CMS finds that the provider or supplier meets all the applicable Medicare conditions. If CMS finds that an accredited facility meets the Life Safety Code Standard by virtue of a plan of correction, the State survey agency will continue to monitor the facility until it is in compliance with the Life Safety Code Standard. [58 FR 61840, Nov. 23, 1993] (a) Review and approval of national accreditation organization. CMS's review and evaluation of a national accreditation organization will be conducted in accordance with, but will not necessarily be limited to, the following general criteria— (1) The equivalency of an accreditation organization's accreditation requirements of an entity to the comparable CMS requirements for the entity; (2) The organization's survey process to determine— (i) The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training; (ii) The comparability of survey procedures to those of State survey agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities; (iii) The organization's procedures for monitoring providers or suppliers found by the organization to be out of compliance with program requirements. These monitoring procedures are to be used only when the organization identifies noncompliance. If noncompliance is identified through validation surveys, the State survey agency monitors corrections as specified at §488.7(b)(3); (iv) The ability of the organization to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner; (v) The ability of the organization to provide CMS with electronic data in ASCII comparable code and reports necessary for effective validation and assessment of the organization survey process; (vi) The adequacy of staff and other resources; (vii) The organization's ability to provide adequate funding for performing required surveys; and (viii) The organization's policies with respect to whether surveys are announced or unannounced; and (3) The accreditation organization's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans). (b) Notice and comment. (1) CMS will publish a proposed notice in the (2) CMS will publish a final notice in the (c) Effects of approval of an accreditation organization. CMS will deem providers and suppliers accredited by an approved accreditation organization to meet the Medicare conditions for which the approval of deeming authority has specifically been granted. The deeming authority will take effect 90 days following the publication of the final notice. (d) Continuing Federal oversight of equivalency of an accreditation organization and removal of deeming authority. This paragraph establishes specific criteria and procedures for continuing oversight and for removing the approval of deeming authority of a national accreditation organization. (1) Comparability review. CMS will compare the equivalency of an accreditation organization's accreditation requirements to the comparable CMS requirements if— (i) CMS imposes new requirements or changes its survey process; (ii) An accreditation organization proposes to adopt new requirements or change its survey process. An accreditation organization must provide written notification to CMS at least 30 days in advance of the effective date of any proposed changes in its accreditation requirements or survey process; and (iii) An accreditation organization's approval has been in effect for the maximum term specified by CMS in the final notice. (2) Validation review. Following the end of a validation review period, CMS will identify any accreditation programs for which— (i) Validation survey results indicate a rate of disparity between certifications of the accreditation organization and certification of the State agency of 20 percent or more; or (ii) Validation survey results, irrespective of the rate of disparity, indicate widespread or systematic problems in an organization's accreditation process that provide evidence that there is no longer reasonable assurance that accredited entities meet Medicare requirements. (3) Reapplication procedures. (i) Every six years, or sooner as determined by CMS, an approved accreditation organization must reapply for continued approval of deeming authority. CMS will notify the organization of the materials the organization must submit as part of the reapplication procedure. (ii) An accreditation organization that is not meeting the requirements of this subpart, as determined through a comparability review, must furnish CMS, upon request and at any time, with the reapplication materials CMS requests. CMS will establish a deadline by which the materials are to be submitted. (e) Notice. If a comparability or validation review reveals documentation that an accreditation organization is not meeting the requirements of this subpart, CMS will provide written notice to the organization indicating that its deeming authority approval may be in jeopardy and that a deeming authority review is being initiated. The notice provides the following information— (1) A statement of the requirements, instances, rates or patterns of discrepancies that were found as well as other related documentation; (2) An explanation of CMS's deeming authority review on which the final determination is based; (3) A description of the process available if the accreditation organization wishes an opportunity to explain or justify the findings made during the comparability or validation review; (4) A description of the possible actions that may be imposed by CMS based on the findings from the validation review; and (5) The reapplication materials the organization must submit and the deadline for their submission. (f) Deeming authority review. (1) CMS will conduct a review of an accreditation organization's accreditation program if the comparability or validation review produces findings as described at paragraph (d)(1) or (2), respectively, of this section. CMS will review as appropriate either or both— (i) The requirements of the accreditation organization; or (ii) The criteria described in paragraph (a)(1) of this section to reevaluate whether the accreditation organization continues to meet all these criteria. (2) If CMS determines, following the deeming authority review, that the accreditation organization has failed to adopt requirements comparable to CMS's or submit new requirements timely, the accreditation organization may be given a conditional approval of its deeming authority for a probationary period of up to 180 days to adopt comparable requirements. (3) If CMS determines, following the deeming authority review, that the rate of disparity identified during the validation review meets either of the criteria set forth in paragraph (d)(2) of this section CMS— (i) May give the accreditation organization conditional approval of its deeming authority during a probationary period of up to one year (whether or not there are also noncomparable requirements) that will be effective 30 days following the date of this determination; (ii) Will require the accreditation organization to release to CMS upon its request any facility-specific data that is required by CMS for continued monitoring: (iii) Will require the accreditation organization to provide CMS with a survey schedule for the purpose of intermittent onsite monitoring by CMS staff, State surveyors, or both; and (iv) Will publish in the Medicare Annual Report to Congress the name of any accreditation organization given a probationary period by CMS. (4) Within 60 days after the end of any probationary period, CMS will make a final determination as to whether or not an accreditation program continues to meet the criteria described at paragraph (a)(1) of this section and will issue an appropriate notice (including reasons for the determination) to the accreditation organization and affected providers or suppliers. This determination will be based on any of the following— (i) The evaluation of the most current validation survey and review findings. The evaluation must indicate an acceptable rate of disparity of less than 20 percent between the certifications of the accreditation organization and the certifications of the State agency as described at paragraph (d)(2)(i) of this section in order for the accreditation organization to retain its approval; (ii) The evaluation of facility-specific data, as necessary, as well as other related information; (iii) The evaluation of an accreditation organization's surveyors in terms of qualifications, ongoing training composition of survey team, etc.; (iv) The evaluation of survey procedures; or (v) The accreditation requirements. (5) If the accreditation program has not made improvements acceptable to CMS during the probationary period, CMS may remove recognition of deemed authority effective 30 days from the date that it provides written notice to the organization that its deeming authority will be removed. (6) The existence of any validation review, deeming authority review, probationary period, or any other action by CMS, does not affect or limit the conducting of any validation survey. (7) CMS will publish a notice in the (8) After CMS removes approval of an accreditation organization's deeming authority, an affected provider's or supplier's deemed status continues in effect 60 days after the removal of approval. CMS may extend the period for an additional 60 days for a provider or supplier if it determines that the provider or supplier submitted an application within the initial 60 day timeframe to another approved accreditation organization or to CMS so that a certification of compliance with Medicare conditions can be determined. (9) Failure to comply with the timeframe requirements specified in paragraph (f)(8) of this section will jeopardize a provider's or supplier's participation in the Medicare program and where applicable in the Medicaid program. (g) If at any time CMS determines that the continued approval of deeming authority of any accreditation organization poses an immediate jeopardy to the patients of the entities accredited by that organization, or such continued approval otherwise constitutes a significant hazard to the public health, CMS may immediately withdraw the approval of deeming authority of that accreditation organization. (h) Any accreditation organization dissatisfied with a determination to remove its deeming authority may request a reconsideration of that determination in accordance with subpart D of this part. [58 FR 61841, Nov. 23, 1993] As part of the application review process, the validation review process, or the continuing oversight of an accreditation organization's performance, CMS may conduct an onsite inspection of the accreditation organization's operations and offices to verify the organization's representations and to assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, the review of documents, auditing meetings concerning the accreditation process, the evaluation of survey results or the accreditation decision-making process, and interviews with the organization's staff. [58 FR 61842, Nov. 23, 1993] (a) Section 1864(a) of the Act requires the Secretary to enter into an agreement with any State that is able and willing to do so, under which appropriate State or local survey agencies will determine whether: (1) Providers or prospective providers meet the Medicare conditions of participation or requirements (for SNFs and NFs); (2) Suppliers meet the conditions for coverage; and (3) Rural health clinics meet the conditions of certification. (b) Section 1865(a) of the Act provides that if an institution is accredited as a hospital by the JCAHO, it will be deemed to meet the conditions of participation: (1) Except those specified in §488.5; (2) Provided that such hospital, if it is included within a validation survey, authorizes the JCAHO to release to CMS (on a confidential basis) upon request a copy of the most current JCAHO accreditation survey. (c) Section 1864(c) of the Act authorizes the Secretary to enter into agreements with State survey agencies for the purpose of conducting validation surveys in hospitals accredited by the JCAHO. Section 1865(b) provides that an accredited hospital which is found after a validation survey to have significant deficiencies related to the health and safety of patients will no longer be deemed to meet the conditions of participation. (d) Section 1865(a) of the Act also provides that if CMS finds that accreditation of a hospital; psychiatric hospital; SNF; HHA; hospice; ASC; RHC; CORF; laboratory; screening mammography service; critical access hospital; or clinic, rehabilitation agency, or public health agency provider of outpatient physical therapy, occupational therapy, or speech pathology services by any national accreditation organization provides reasonable assurance that any or all Medicare conditions are met, CMS may treat the provider or supplier as meeting the conditions. [53 FR 22859, June 17, 1988, as amended at 56 FR 48879, Sept. 26, 1991; 58 FR 61842, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997] State and local agencies that have agreements under section 1864(a) of the Act perform the following functions: (a) Survey and make recommendations regarding the issues listed in §488.10. (b) Conduct validation surveys of accredited facilities as provided in §488.7. (c) Perform other surveys and carry out other appropriate activities and certify their findings to CMS. (d) Make recommendations regarding the effective dates of provider agreements and supplier approvals in accordance with §489.13 of this chapter. [62 FR 43936, Aug. 18, 1997] Certifications by the State survey agency represent recommendations to CMS. (a) On the basis of these recommendations, CMS will determine whether: (1) A provider or supplier is eligible to participate in or be covered under the Medicare program; or (2) An accredited hospital is deemed to meet the Medicare conditions of participation or is subject to full review by the State survey agency. (b) Notice of CMS's determination will be sent to the provider or supplier. When a QIO is conducting review activities under section 1154 of the Act and part 466 of this chapter, its activities are in lieu of the utilization review and evaluation activities required of health care institutions under sections 1861(e)(6), and 1861(k) of the Act. [59 FR 56237, Nov. 10, 1994] (a) The findings of the State agency with respect to each of the conditions of participation, requirements (for SNFs and NFs), or conditions for coverage must be adequately documented. When the State agency certifies to the Secretary that a provider or supplier is not in compliance with the conditions or requirements (for SNFs and NFs), and therefore not eligible to participate in the program, such documentation includes, in addition to the description of the specific deficiencies which resulted in the agency's recommendation, any provider or supplier response. (b) If a provider or supplier is certified by the State agency as in compliance with the conditions or participation requirements (for SNFs and NFs) or as meeting the requirements for special certification (see §488.54), with deficiencies not adversely affecting the health and safety of patients, the following information will be incorporated into the finding: (1) A statement of the deficiencies that were found. (2) A description of further action that is required to remove the deficiencies. (3) A time-phased plan of correction developed by the provider and supplier and concurred with by the State agency. (4) A scheduled time for a resurvey of the institution or agency to be conducted by the State agency within 90 days following the completion of the survey. (c) If, on the basis of the State certification, the Secretary determines that the provider or supplier is eligible to participate, the information described in paragraph (b) of this section will be incorporated into a notice of eligibility to the provider or supplier. (d) If the State agency receives information to the effect that a hospital or a critical access hospital (as defined in section 1861(mm)(1) of the Act) has violated §489.24 of this chapter, the State agency is to report the information to CMS promptly. [39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, and further redesignated at 42 FR 52826, Sept. 30, 1977. Redesignated at 53 FR 23100, June 17, 1988; 59 FR 32120, June 22, 1994; 59 FR 56237, Nov. 10, 1994; 62 FR 46037, Aug. 29, 1997] Effective Date Note: At 59 FR 32120, June 22, 1994, in §488.18, paragraph (d) was added. The amendment contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget. (a) Determinations by CMS to the effect that a provider or supplier is in compliance with the conditions of participation, or requirements (for SNFs and NFs), or the conditions for coverage are made as often as CMS deems necessary and may be more or less than a 12-month period, except for SNFs, NFs and HHAs. (See §488.308 for special rules for SNFs and NFs.) (b) The responsibilities of State survey agencies in the review and certification of compliance are as follows: (1) Resurvey providers or suppliers as frequently as necessary to ascertain compliance and confirm the correction of deficiencies; (2) Review reports prepared by a Professional Standards Review Organization (authorized under Part B Title XI of the Act) or a State inspection of care team (authorized under Title XIX of the Act) regarding the quality of a facility's care; (3) Evaluate reports that may pertain to the health and safety of patients; and (4) Take appropriate actions that may be necessary to achieve compliance or certify noncompliance to CMS. (c) A State survey agency certification to CMS that a provider or supplier is no longer in compliance with the conditions of participation or requirements (for SNFs and NFs) or conditions for coverage will supersede the State survey agency's previous certification. (Secs. 1102, 1814, 1861, 1863 through 1866, 1871, and 1881; 42 U.S.C. 1302, 1395f, 1395x, 1395z through 1395cc, 1395hh, and 1395rr) [45 FR 74833, Nov. 12, 1981. Redesignated and amended at 53 FR 23100, June 17, 1988, and further amended at 54 FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26, 1991; 59 FR 56237, Nov. 10, 1994] (a) Special rules for certification of noncompliance for SNFs and NFs are set forth in §488.330. (b) The State agency will certify that a provider or supplier is not or is no longer in compliance with the conditions of participation or conditions for coverage where the deficiencies are of such character as to substantially limit the provider's or supplier's capacity to furnish adequate care or which adversely affect the health and safety of patients; or (c) If CMS determines that an institution or agency does not qualify for participation or coverage because it is not in compliance with the conditions of participation or conditions for coverage, or if a provider's agreement is terminated for that reason, the institution or agency has the right to request that the determination be reviewed. (Appeals procedures are set forth in Part 498 of this chapter.) [59 FR 56237, Nov. 10, 1994] (a) Additional rules for certification of compliance for SNFs and NFs are set forth in §488.330. (b) The decision as to whether there is compliance with a particular requirement, condition of participation, or condition for coverage depends upon the manner and degree to which the provider or supplier satisfies the various standards within each condition. Evaluation of a provider's or supplier's performance against these standards enables the State survey agency to document the nature and extent of deficiencies, if any, with respect to a particular function, and to assess the need for improvement in relation to the prescribed conditions. (c) The State survey agency must adhere to the following principles in determining compliance with participation requirements: (1) The survey process is the means to assess compliance with Federal health, safety and quality standards; (2) The survey process uses resident outcomes as the primary means to establish the compliance status of facilities. Specifically surveyors will directly observe the actual provision of care and services to residents, and the effects of that care, to assess whether the care provided meets the needs of individual residents; (3) Surveyors are professionals who use their judgment, in concert with Federal forms and procedures, to determine compliance; (4) Federal procedures are used by all surveyors to ensure uniform and consistent application and interpretation of Federal requirements; (5) Federal forms are used by all surveyors to ensure proper recording of findings and to document the basis for the findings. (d) The State survey agency must use the survey methods, procedures, and forms that are prescribed by CMS. (e) The State survey agency must ensure that a facility's actual provision of care and services to residents and the effects of that care on residents are assessed in a systematic manner. [59 FR 56237, Nov. 10, 1994] (a) If a provider or supplier is found to be deficient with respect to one or more of the standards in the conditions of participation or conditions for coverage, it may participate in or be covered under the Health Insurance for the Aged and Disabled Program only if the facility has submitted an acceptable plan of correction for achieving compliance within a reasonable period of time acceptable to the Secretary. (b) The existing deficiencies noted either individually or in combination neither jeopardize the health and safety of patients nor are of such character as to seriously limit the provider's capacity to render adequate care. (c)(1) If it is determined during a survey that a provider or supplier is not in compliance with one or more of the standards, it is granted a reasonable time to achieve compliance. (2) The amount of time depends upon the— (i) Nature of the deficiency; and (ii) State survey agency's judgment as to the capabilities of the facility to provide adequate and safe care. (d) Ordinarily a provider or supplier is expected to take the steps needed to achieve compliance within 60 days of being notified of the deficiencies but the State survey agency may recommend that additional time be granted by the Secretary in individual situations, if in its judgment, it is not reasonable to expect compliance within 60 days, for example, a facility must obtain the approval of its governing body, or engage in competitive bidding. [59 FR 56237, Nov. 10, 1994]
Title 42: Public Health
PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
Subpart A—General Provisions
§ 488.1 Definitions.
§ 488.2 Statutory basis.
§ 488.3 Conditions of participation; conditions for coverage; and long-term care requirements.
§ 488.4 Application and reapplication procedures for accreditation organizations.
§ 488.5 Effect of JCAHO or AOA accreditation of hospitals.
§ 488.6 Other national accreditation programs for hospitals and other providers and suppliers.
§ 488.7 Validation survey.
§ 488.8 Federal review of accreditation organizations.
§ 488.9 Onsite observation of accreditation organization operations.
§ 488.10 State survey agency review: Statutory provisions.
§ 488.11 State survey agency functions.
§ 488.12 Effect of survey agency certification.
§ 488.14 Effect of QIO review.
§ 488.18 Documentation of findings.
§ 488.20 Periodic review of compliance and approval.
§ 488.24 Certification of noncompliance.
§ 488.26 Determining compliance.
§ 488.28 Providers or suppliers, other than SNFs and NFs, with deficiencies.
