42 CFR Part 488 — Survey, Certification, and Enforcement Procedures

PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES Authority: 42 U.S.C 1302 and 1395hh. Source: 53 FR 22859, June 17, 1988, unless otherwise noted. Subpart A—General Provisions § 488.1 Definitions. Link to an amendment published at 91 FR 36463, June 16, 2026. As used in this part— Act Certification Conditions for certification Conditions for coverage Conditions of participation Deemed status Full review Immediate jeopardy Medicare condition National accrediting organization Provider of services or provider Rate of disparity 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 State State survey agency Substantial allegation of non-compliance Supplier [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; 71 FR 68230, Nov. 24, 2006; 80 FR 29834, May 22, 2015; 88 FR 59335, Aug. 28, 2023] § 488.2 Statutory basis. This part is based on the indicated provisions of the following sections of the Act: Table 1 to § 488.2 Section Subject 1128 Exclusion of entities from participation in Medicare. 1128A Civil money penalties. 1138(b) Requirements for organ procurement organizations and organ procurement agencies. 1814 Conditions for, and limitations on, payment for Part A services. 1819 Requirements for skilled nursing facilities (SNFs). 1820 Requirements for critical access hospitals (CAHs). 1822 Hospice Program survey and enforcement procedures. 1832(a)(2)(C) Requirements for Organizations that provide outpatient physical therapy and speech language pathology services. 1832(a)(2)(F) Requirements for ambulatory surgical centers (ASCs). 1832(a)(2)(J) Requirements for partial hospitalization services and intensive outpatient services provided by CMHCs. 1861(e) Requirements for hospitals. 1861(f) Requirements for psychiatric hospitals. 1861(m) Requirements for Home Health Services. 1861(o) Requirements for Home Health Agencies. 1861(p)(4) Requirements for rehabilitation agencies. 1861(z) Institutional planning standards that hospitals and SNFs must meet. 1861(aa) Requirements for rural health clinics (RHCs) and federally qualified health centers (FQHCs). 1861(cc)(2) Requirements for comprehensive outpatient rehabilitation facilities (CORFs). 1861(dd) Requirements for hospices. 1861(ee) Discharge planning guidelines for hospitals. 1861(ff)(3)(A) Requirements for CMHCs. 1861(ss)(2) Accreditation of religious nonmedical health care institutions. 1861(kkk) Requirements for rural emergency hospitals (REHs). 1863 Consultation with state agencies, accrediting bodies, and other organizations to develop conditions of participation, conditions for coverage, conditions for certification, and requirements for providers or suppliers. 1864 Use of State survey agencies. 1865 Effect of accreditation. 1875(b) Requirements for performance review of CMS-approved accreditation programs. 1880 Requirements for hospitals and SNFs of the Indian Health Service. 1881 Requirements for end stage renal disease (ESRD) facilities. 1883 Requirements for hospitals that furnish extended care services. 1891 Conditions of participation for home health agencies; home health quality. 1902 Requirements for participation in the Medicaid program. 1913 Medicaid requirements for hospitals that provide nursing facility (NF) care. 1919 Medicaid requirements for NFs. [88 FR 59335, Aug. 28, 2023, as amended at 88 FR 82183, Nov. 22, 2023] § 488.3 Conditions of participation, conditions for coverage, conditions for certification and long term care requirements. (a) Basic rules. (1) Meet the applicable statutory definitions in section 1138(b), 1819, 1820, 1832(a)(2)(C), 1832(a)(2)(F), 1832(a)(2)(J), 1834(e), 1861, 1881, 1883, 1891, 1913 or 1919 of the Act. (2) Be in compliance with the applicable conditions, certification requirements, or long term care requirements prescribed in part 405 subparts U or X, part 410 subpart E, part 416, part 418 subpart C, parts 482 through 486, part 491 subpart A, or part 494 of this chapter. (b) Special conditions. (1) The Secretary may, at a state's request, approve health and safety requirements for providers or suppliers in the state that exceed Medicare program requirements. (2) If a state or political subdivision imposes requirements on institutions (that exceed the Medicare program requirements) 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 imposes similar requirements as a condition for payment under Medicare in that state or political subdivision. [80 FR 29835, May 22, 2015] § 488.4 General rules for a CMS-approved accreditation program for providers and suppliers. Link to an amendment published at 91 FR 36463, June 16, 2026. (a) The following requirements apply when a national accrediting organization has applied for CMS approval of a provider or supplier accreditation program and CMS has found that the program provides reasonable assurance for providers or suppliers accredited under the program: (1) When a provider or supplier demonstrates full compliance with all of the accreditation program requirements of the accrediting organization's CMS-approved accreditation program, the accrediting organization may recommend that CMS grant deemed status to the provider or supplier. (2) CMS may deem the provider or supplier, excluding kidney transplant centers within a hospital and ESRD facilities, to be in compliance with the applicable Medicare conditions or requirements. The deemed status provider or supplier is subject to validation surveys as provided at § 488.9. (b) [Reserved] [80 FR 29835, May 22, 2015] § 488.5 Application and re-application procedures for national accrediting organizations. Link to an amendment published at 91 FR 36464, June 16, 2026. (a) Information submitted with application. (1) Documentation that demonstrates the organization meets the definition of a “national accrediting organization” under § 488.1 as it relates to the accreditation program. (2) The type of provider or supplier accreditation program for which the organization is requesting approval or re-approval. (3) A detailed crosswalk (in table format) that identifies, for each of the applicable Medicare conditions or requirements, the exact language of the organization's comparable accreditation requirements and standards. (4) A detailed description of the organization's survey process to confirm that a provider or supplier meets or exceeds the Medicare program requirements. This description must include all of the following information: (i) Frequency of surveys performed and an agreement by the organization to re-survey every accredited provider or supplier, through unannounced surveys, no later than 36 months after the prior accreditation effective date, including an explanation of how the accrediting organization will maintain the schedule it proposes. If there is a statutorily-mandated survey interval of less than 36 months, the organization must indicate how it will adhere to the statutory schedule. (ii) Documentation demonstrating the comparability of the organization's survey process and surveyor guidance to those required for state survey agencies conducting federal Medicare surveys for the same provider or supplier type, in accordance with the applicable requirements or conditions of participation or conditions for coverage or certification. (iii) Copies of the organization's survey forms, guidelines, and instructions to surveyors. (iv) Documentation demonstrating that the organization's survey reports identify, for each finding of non-compliance with accreditation standards, the comparable Medicare CoP, CfC, conditions for certification, or requirements. (v) Description of the organization's accreditation survey review process. (vi) Description of the organization's procedures and timelines for notifying surveyed facilities of non-compliance with the accreditation program's standards. (vii) Description of the organization's procedures and timelines for monitoring the provider's or supplier's correction of identified non-compliance with the accreditation program's standards. (viii) A statement acknowledging that, as a condition for CMS approval of a national accrediting organization's accreditation program, the organization agrees to provide CMS with information extracted from each accreditation survey for a specified provider or supplier as part of its data submissions required under paragraph (a)(11)(ii) of this section, a copy of all survey reports and related information for applicants seeking initial participation in Medicare, and, upon request from CMS, a copy of the most recent accreditation survey for a specified provider or supplier, together with any other information related to the survey as CMS may require (including corrective action plans). (ix) A statement acknowledging that the accrediting organization will provide timely notification to CMS when an accreditation survey or complaint investigation identifies an immediate jeopardy as that term is defined at § 489.3 of this chapter. Using the format specified by CMS, the accrediting organization must notify CMS within two business days from the date the accrediting organization identifies the immediate jeopardy. (x) For accrediting organizations applying for approval or re-approval of CMS-approved hospice programs, a statement acknowledging that the accrediting organization (AO) will include a statement of deficiencies (that is, the Form CMS-2567 or a successor form) to document findings of the hospice Medicare conditions of participation in accordance with section 1822(a)(2)(A)(ii) of the Act and will submit such in a manner specified by CMS. (5) The criteria for determining the size and composition of the organization's survey teams for the type of provider or supplier to be accredited, including variations in team size and composition for individual provider or supplier surveys. (6) The overall adequacy of the number of the organization's surveyors, including how the organization will increase the size of the survey staff to match growth in the number of accredited facilities while maintaining re-accreditation intervals for existing accredited facilities. (7) A description of the education and experience requirements surveyors must meet. (8) A description of the content and frequency of the organization's in-service training it provides to survey personnel. (9) A description of the organization's evaluation systems used to monitor the performance of individual surveyors and survey teams. (10) The organization's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions. (11) A description of the organization's data management and analysis system for its surveys and accreditation decisions, including all of the following: (i) A detailed description of how the organization uses its data to assure the compliance of its accreditation program with the Medicare program requirements. (ii) A statement acknowledging that the organization agrees to submit timely, accurate, and complete data to support CMS's evaluation of the accrediting organization's performance. Data to be submitted includes, but is not limited to, accredited provider or supplier identifying information, survey schedules, survey findings, and notices of accreditation decisions. The organization must submit necessary data according to the instructions and timeframes CMS specifies. (12) The organization's procedures for responding to, and investigating, complaints against accredited facilities, including policies and procedures regarding referrals when applicable to appropriate licensing bodies and ombudsman programs. (13) The organization's accreditation status decision-making process, including its policies and procedures for granting, withholding, or removing accreditation status for facilities that fail to meet the accrediting organization's standards or requirements, assignment of less than full accreditation status or other actions taken by the organization in response to non-compliance with its standards and requirements. The organization must furnish the following: (i) A description of all types and categories of accreditation decisions associated with the program for which approval is sought, including the duration of each. (ii) A statement acknowledging that the organization agrees to notify CMS (in a manner CMS specifies) of any decision to revoke, withdraw, or revise the accreditation status of a specific deemed status provider or supplier, within three business days from the date the organization takes an action. (14) A list of all facilities currently accredited by the organization under the program for which CMS approval is sought, including the type and category of accreditation currently held by each provider or supplier, and the expiration date of each provider's or supplier's current accreditation. (15) A schedule of all surveys expected to be conducted by the organization for the accreditation program under review during the 6-month period following submission of the application. (16) The three most recent audited financial statements of the organization that demonstrate that the organization's staffing, funding, and other resources are adequate to perform the required surveys and related activities. (17) A statement that it will: (i) Provide written notification to CMS and to all providers or suppliers accredited under a CMS-approved accreditation program at least 90 calendar days in advance of the effective date of a decision by the organization to voluntarily terminate its CMS-approved accreditation program, including the implications for their deemed status in accordance with § 488.8(g)(2); (ii) Adhere to the requirements for written notice to its accredited providers or suppliers at § 488.8(e) in the case of an involuntary termination; and (iii) Include a written statement that if a fully accredited and deemed facility in good standing provides written notification that they wish to voluntarily withdraw from the accrediting organization's CMS-approved accreditation program, the accrediting organization must continue the facility's current accreditation in full force and effect until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first. (18) A statement that it will provide written notification to CMS of any proposed changes in the organization's CMS-approved accreditation program and that it agrees not to implement the proposed changes without prior written notice of continued program approval from CMS except as provided for at § 488.8(b)(2). (19) A statement that, in response to a written notice from CMS to the organization of a change in the applicable conditions or requirements or in the survey process, the organization will provide CMS with proposed corresponding changes in the organization's requirements for its CMS-approved accreditation program to ensure continued comparability with the CMS conditions or requirements or survey process. The organization must comply with the following requirements: (i) The proposed changes must be submitted within 30 calendar days of the date of the written CMS notice to the organization or by a date specified in the notice, whichever is later. CMS will give due consideration to an organization's request for an extension of the deadline. (ii) The proposed changes will not be implemented without prior written notice of continued program approval from CMS, except as provided for at § 488.8(b)(1)(iv). (20) A statement acknowledging that, as a condition for CMS's approval of an accreditation program, the organization will agree to permit its surveyors to serve as witnesses in a legal proceeding if CMS takes an adverse action against a provider or supplier on the basis of the organization's accreditation survey findings, and will cooperate with CMS to make surveyors and other staff available when needed. (b) Additional information needed. (c)(1) Withdrawing an application. (2) Voluntary termination of a CMS-approved accreditation program. (d) Re-submitting a request. (i) Revises its accreditation program to address the issues related to the denial of its previous request. (ii) Demonstrates that it can provide reasonable assurance. (iii) Resubmits the application in its entirety. (2) If an accrediting organization has requested, in accordance with subpart D of this part, a reconsideration of CMS's determination that its request for approval of an accreditation program is denied, it may not submit a new application for approval of an accreditation program for the type of provider or supplier at issue in the reconsideration until the reconsideration is administratively final. (e) Public notice and comment. Federal Register (1) Proposed notice. (2) Final notice. (i) Approval or re-approval. (ii) Disapproval. (f) Change of ownership. What Constitutes Change of Ownership. (1) Notice to CMS. (i) This notice requirement applies to any national accrediting organization with CMS-approved accreditation program(s) that is the subject of a potential or actual change of ownership transaction, including accrediting organizations for Advanced Diagnostic Imaging (ADI) suppliers; Home Infusion Therapy (HIT) suppliers; Diabetic Self-Management Training (DSMT) entities, and clinical laboratories. (ii) This notice must be provided to CMS in writing. (iii) This notice must be provided to CMS no less than 90 calendar days prior to the anticipated effective date of the change of ownership transaction. (iv) CMS will complete their review of the AO's request for approval for the transfer of the existing CMS approval for the accreditation programs to be transferred in the change of ownership within 90 days from receipt of said AO's request. (2) Information submitted with the request for approval for change of ownership transaction. (i) Seek approval from CMS for the purchase or transfer of the existing CMS approval for the accreditation program(s) to be transferred in the change of ownership event; and (ii) Meet the requirements of paragraphs (f)(2)(iii) through (f)(4) of this section to demonstrate that the entities that will be accredited with the transferred accrediting program(s) continue to meet or exceed the applicable Medicare conditions or requirements. (iii) The following information must be submitted to CMS in the purchaser's/buyer's/transferee's request for approval of a transfer of the existing CMS approval for the accreditation program(s) to be transferred in the change or ownership transaction: (A) The legal name and address of the new owner; (B) The three most recent audited financial statements of the organization that demonstrate the organization's staffing, funding and other resources are adequate to perform the required surveys and related activities; (C) A transition plan that summarizes the details of how the accreditation functions will be transitioned to the new owner, including: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (D) The prospective new AO's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions, as required by paragraph (a)(10) of this section. (3) Written acknowledgements. (i) If the application for the transfer of the existing CMS-approval for the accreditation program(s) to be transferred in the change of ownership transaction is approved by CMS, said purchaser/buyer/transferee must assume complete responsibility for the operations (that is, managerial, financial, and legal) of the CMS-approved accreditation programs transferred, immediately upon the finalization of the change of ownership transaction; (ii) The purchaser/buyer/transferee agrees to operate the transferred CMS-approved accreditation program(s) under all of the CMS imposed terms and conditions, to include program reviews and probationary status terms, currently approved by CMS; and (iii) The purchaser/buyer/transferee must not operate the accreditation program(s) it acquired in the change in ownership transaction as CMS approved accreditation programs, until the effective date set forth within the notice of approval from CMS. (iv) The purchaser/buyer/transferee agrees to operate the transferred CMS-approved accreditation program(s) under all of the terms and conditions found at §§ 488.5 through 488.9. (4) Notification. (i) All parties to the change of ownership transaction must notify the providers and suppliers affected by such change within 15 calendar days after being notified of CMS's approval of the transfer of the existing CMS-approval for the accreditation programs to be transferred in the change of ownership transaction. (ii) If applicable, the purchaser/buyer/transferee must acknowledge in writing to CMS that the accrediting organization or accreditation program(s) being acquired through a purchase or transfer of ownership was under a performance review or under probationary status at the time the change of ownership notice was submitted. (5) Federal Register notice. Federal Register (6) Notification to parties in the event that CMS does not approve the transfer of the existing CMS approval. (7) Withdrawal of CMS approval for transferred accreditation programs due to failure to notify CMS of intent to transfer accreditation programs. (i) The existing AO would be permitted to continue operating their existing CMS-approved accreditation programs, if the change of ownership transaction was not completed, unless our review of the transaction revealed issues with the AO that were the subject of the un-finalized change of ownership transaction that was previously unknown to CMS. (ii) If a change of ownership transaction was completed without notice to CMS or the approval of CMS, CMS would be able to withdraw the existing approval of the AO's accreditation programs in accordance with § 488.8(c)(3)(ii) and (iii). (8) Withdrawal of CMS approval for accreditation programs which are transferred notwithstanding CMS' disapproval of the transfer. (9) Requirements for continuation of a deemed status accreditation of Medicare-certified providers and suppliers after CMS withdraws the existing approval of the transferred accreditation program(s). (i) The Medicare-certified provider or supplier must submit an application to another CMS-approved accreditation program within 60 calendar days from the date of publication of the removal notice in the Federal Register (ii) The Medicare-certified provider or supplier must provide written notice to the SA that it has submitted an application for accreditation under another CMS-approved accreditation program within this same 60-calendar day timeframe in accordance with § 488.8(g). (iii) Failure to comply with the timeframe requirements specified in § 488.8(g) will place the provider or supplier under the SA's authority for continued participation in Medicare and on-going monitoring. (10) Requirements for continuation of accreditation for non-certified suppliers when CMS withdraws the existing approval of the transferred accreditation program(s). (i) The non-certified supplier must submit an application to another CMS-approved accreditation program within 60 calendar days from the date of publication of the removal notice in the Federal Register (ii) The non-certified supplier must provide written notice to CMS stating that it has submitted an application for accreditation under another CMS-approved accreditation program within the 60-calendar days from the date of publication of the removal notice in the Federal Register (iii) Failure to comply with the above-stated timeframe requirements will result in de-recognition of such provider or supplier's accreditation. [80 FR 29835, May 22, 2015, as amended at 82 FR 38516, Aug. 14, 2017; 82 FR 46143, Oct. 4, 2017; 83 FR 56631, Nov. 13, 2018; 86 FR 62425, Nov. 9, 2021; 87 FR 25427, Apr. 29, 2022; 87 FR 36410, June 17, 2022] § 488.6 Providers or suppliers that participate in the Medicaid program under a CMS-approved accreditation program. A provider or supplier that has been granted “deemed status” by CMS by virtue of its accreditation from a CMS-approved accreditation program is eligible to participate in the Medicaid program if they are not required under Medicaid regulations to comply with any requirements other than Medicare participation requirements. [80 FR 29837, May 22, 2015] § 488.7 Release and use of accreditation surveys. A Medicare participating provider or supplier deemed to meet program requirements in accordance with § 488.4 must authorize its accrediting organization to release to CMS a copy of its most current accreditation survey and any information related to the survey that CMS may require (including, but not limited to, corrective action plans). (a) CMS may determine that a provider or supplier does not meet the applicable Medicare conditions or requirements on the basis of its own investigation of the accreditation survey or any other information related to the survey. (b) With the exception of home health agency and hospice program surveys, general disclosure of an accrediting organization's survey information is prohibited under section 1865(b) of the Act. CMS may publicly disclose an accreditation survey and information related to the survey, upon written request, to the extent that the accreditation survey and survey information are related to an enforcement action taken by CMS. (c) CMS posts inspection reports from a State or local survey agency or accrediting organization conducted on or after October 1, 2022, for hospice programs, including copies of a hospice program's survey deficiencies, and enforcement actions (for example, involuntary terminations) taken as a result of such surveys, on its public website in a manner that is prominent, easily accessible, readily understandable, and searchable for the general public and allows for timely updates. [80 FR 29837, May 22, 2015, as amended at 86 FR 62425, Nov. 9, 2021] § 488.8 Ongoing review of accrediting organizations. Link to an amendment published at 91 FR 36466, June 16, 2026. (a) Performance review. (1) Review of the organization's survey activity. (2) Analysis of the results of the validation surveys under § 488.9(a)(1), including the rate of disparity between certifications of the accrediting organization and certifications of the SA. (3) Review of the organization's continued fulfillment of the requirements in § 488.5(a). (b) Comparability review. (1) CMS imposes new Medicare certification requirements or changes its survey process. (i) CMS provides written notice of the changes to the affected accrediting organization. (ii) CMS specifies in its written notice a timeframe, not less than 30 calendar days from the date of the notice, for the accrediting organization to submit its proposed equivalent changes, including its implementation timeframe, for CMS review. CMS may extend the deadline after due consideration of a written request for extension by the accrediting organization, submitted prior to the original deadline. (iii) After completing the comparability review CMS provides written notification to the organization whether or not the accreditation program, including the proposed revisions and implementation timeframe, continues to meet or exceed all applicable Medicare requirements. (iv) If, no later than 60 calendar days after receipt of the organization's proposed changes, CMS does not provide the written notice to the organization required in paragraph (b)(1)(iii) of this section, then the revised program will be deemed to meet or exceed all applicable Medicare requirements and to have continued CMS approval. (v) If an organization fails to submit its proposed changes within the required timeframe, or fails to implement the proposed changes that have been determined by CMS or deemed to be comparable, CMS may open an accreditation program review in accordance with paragraph (c) of this section. (2) An accrediting organization proposes to adopt new requirements or to change its survey process. (i) An accrediting organization must provide written notice to CMS of any proposed changes in its accreditation requirements or survey process and must not implement any changes before receiving CMS's approval, except as provided below. (ii) If, no later than 60 calendar days after receipt of the organization's proposed changes, CMS does not provide written notice to the organization that the accreditation program, including the proposed revisions, continues or does not continue to meet or exceed all applicable Medicare requirements, then the revised program will be deemed to meet or exceed all applicable Medicare requirements and to have continued CMS approval. (iii) If an organization implements changes that have neither been determined by CMS nor deemed to be comparable to the applicable Medicare requirements, CMS may open an accreditation program review in accordance with paragraph (c) of this section. (c) CMS-approved accreditation program review. (1) If an accreditation program review is initiated, CMS provides written notice to the organization indicating that its CMS-approved accreditation program approval may be in jeopardy and that an accreditation program review is being initiated. The notice provides all of the following information: (i) A statement of the instances, rates or patterns of non-compliance identified, as well as other related information, if applicable. (ii) A description of the process to be followed during the review, including a description of the opportunities for the accrediting organization to offer factual information related to CMS's findings. (iii) A description of the possible actions that may be imposed by CMS based on the findings of the accreditation program review. (iv) The actions the accrediting organization must take to address the identified deficiencies including a timeline for implementation not to exceed 180 calendar days after receipt of the notice that CMS is initiating an accreditation program review. (2) CMS reviews the accrediting organization's plan of correction for acceptability. (3) If CMS determines as a result of the accreditation program review or a review of an application for renewal of an existing CMS-approved accreditation program that the accrediting organization has failed to meet any of the requirements of this subpart, CMS may place the accrediting organization's CMS-approved accreditation program on probation for a period up to 180 calendar days to implement corrective actions, not to exceed the accrediting organization's current term of approval. In the case of a renewal application where CMS has placed the accreditation program on probation, CMS indicates that any approval of the application is conditional while the program is placed on probation. (i) Within 60 calendar days after the end of any probationary period, CMS issues a written determination to the accrediting organization as to whether or not a CMS-approved accreditation program continues to meet the requirements of this subpart, including the reasons for the determination. (ii) If CMS has determined that the accrediting organization does not meet the requirements, CMS withdraws approval of the CMS-approved accreditation program. The notice of determination provided to the accrediting organization includes notice of the removal of approval, reason for the removal, including the effective date determined in accordance with paragraph (c)(3)(iii) of this section. (iii) CMS publishes in the Federal Register (d) Immediate jeopardy. Federal Register (e) Notification of providers or suppliers. Federal Register (f) Request for reconsideration. (g) Continuation of deemed status Involuntary termination. Federal Register. (2) Voluntary termination by accrediting organization. (h) Onsite observations of accrediting organization operations. [80 FR 29837, May 22, 2015] § 488.9 Validation surveys. Link to an amendment published at 91 FR 36467, June 16, 2026. (a) Basis for survey. (1) For a representative sample, the survey may be comprehensive and address all Medicare conditions or requirements, or it may be focused on a specific condition(s) as determined by CMS. (2) For a substantial allegation of noncompliance, the SA surveys for any condition(s) or requirement(s) that CMS determines is related to the allegations. (b) Selection for survey. (2) If a provider or supplier selected for a validation survey fails to cooperate with the SA, it will no longer be deemed to meet the Medicare conditions or requirements, but will be subject to a review by the SA in accordance with § 488.10(a), and may be subject to termination of its provider agreement under § 489.53 of this chapter. (c) Consequences of a finding of non-compliance. (2) CMS may take actions for the deficiencies identified in the state validation survey in accordance with § 488.24, or may first direct the SA to conduct another survey of the provider's or supplier's compliance with specified Medicare conditions or requirements before taking the enforcement actions provided for at § 488.24. (3) If CMS determines that a provider or supplier is not in compliance with applicable Medicare conditions or requirements, the provider or supplier may be subject to termination of the provider or supplier agreement under § 489.53 of this chapter or of the supplier agreement in accordance with the applicable supplier conditions and any other applicable intermediate sanctions and remedies. (d) Re-instating deemed status. (1) It withdraws any prior refusal to authorize its accrediting 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, if applicable. (3) CMS finds that the provider or supplier meets all applicable Medicare CoP, CfC, conditions of certification, or requirements. (e) Impact of adverse actions. [80 FR 29839, May 22, 2015] § 488.10 State survey agency review: Statutory provisions. (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 by a national accrediting organization recognized by the Secretary, it may be deemed to have met the applicable conditions or requirements. (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 institutions accredited by an accreditation program recognized by the Secretary. (d) Section 1865(c) provides that an accredited institution that is found after a validation survey to have significant deficiencies related to health and safety of patients will no longer meet the applicable conditions or requirements. [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; 80 FR 29839, May 22, 2015] § 488.11 State survey agency functions. 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 deemed status providers and suppliers as provided in § 488.9. (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, as amended at 80 FR 29839, May 22, 2015] § 488.12 Effect of survey agency certification. 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) A provider or supplier accredited under a CMS-approved accreditation program remains deemed to meet the Medicare conditions or requirements, or will be placed under the jurisdiction of the SA and subject to further enforcement actions in accordance with the provisions at § 488.9. (b) Notice of CMS's determination will be sent to the provider or supplier. [53 FR 22859, June 17, 1988, as amended at 80 FR 29839, May 22, 2015] § 488.13 Loss of accreditation. If an accrediting organization notifies CMS that it is terminating a provider or supplier due to non-compliance with its CMS-approved accreditation requirements, the SA will conduct a full review in a timely manner. [80 FR 29839, May 22, 2015] § 488.14 Effect of QIO review. 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] § 488.18 Documentation of findings. (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) or a rural emergency hospital (as defined in section 1861(kkk)(2) 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; 88 FR 59335, Aug. 28, 2023] § 488.20 Periodic review of compliance and approval. (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] § 488.24 Certification of noncompliance. (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] § 488.26 Determining compliance. (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 and patient outcomes as the primary means to establish the compliance process of facilities and agencies. Specifically, surveyors will directly observe the actual provision of care and services to residents and/or patients, and the effects of that care, to assess whether the care provided meets the needs of individual residents and/or patients. (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 or agency's actual provision of care and services to residents and patients and the effects of that care on such residents and patients are assessed in a systematic manner. [59 FR 56237, Nov. 10, 1994, as amended at 77 FR 67164, Nov. 8, 2012] § 488.28 Providers or suppliers, other than SNFs, NFs, HHAs, and Hospice programs with deficiencies. (a) If a provider or supplier is found to be deficient in one or more of the standards in the conditions of participation, conditions for coverage, or conditions for certification or requirements, it may participate in, or be covered under, the Medicare program only if the provider or supplier has submitted an acceptable plan of correction for achieving compliance within a reasonable period of time acceptable to CMS. In the case of an immediate jeopardy situation, CMS may require a shorter time period for achieving compliance. (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, as amended at 77 FR 67164, Nov. 8, 2012; 80 FR 29839, May 22, 2015; 86 FR 62425, Nov. 9, 2021] § 488.30 Revisit user fee for revisit surveys. (a) Definitions. Certification Complaint surveys Provider of services, provider, or supplier Revisit survey Substantiated complaint survey (b) Criteria for determining the fee. (i) The average cost per provider or supplier type. (ii) The type of revisit survey conducted (onsite or offsite). (iii) The size of the provider or supplier. (iv) The number of follow-up revisits resulting from uncorrected deficiencies. (v) The seriousness and number of deficiencies. (2) CMS may adjust the fees to account for any regional differences in cost. (c) Fee schedule. Federal Register (d) Collection of fees. (2) Fees for revisit surveys under this section are not allowable items on a cost report, as identified in part 413, subpart B of this chapter, under title XVIII of the Act. (3) Fees for revisit surveys will be due for any revisit surveys conducted during the time period for which authority to levy a revisit user fee exists. (e) Reconsideration process for revisit user fees. (i) If a provider or supplier believes an error of fact has been made in the application of the revisit user fee, such as clerical errors, billing for a fee already paid, or assessment of a fee when there was no revisit conducted, and (ii) If the request for reconsideration is received by CMS within 14 calendar days from the date identified on the revisit user fee assessment notice. (2) CMS will issue a credit toward any future revisit surveys conducted, if the provider or supplier has remitted an assessed revisit user fee and for which a reconsideration request is found in favor of the provider or supplier. If in the event that CMS judges that a significant amount of time has elapsed before such a credit is used, CMS will refund the assessed revisit user fee amount paid to the provider or supplier. (3) CMS will not reconsider the assessment of revisit user fees that request reconsideration of the survey findings or deficiency citations that may have given rise to the revisit, the revisit findings, the need for the revisit itself, or other similarly identified basis for the assessment of the revisit user fee. (f) Enforcement. [72 FR 53648, Sept. 19, 2007, as amended at 82 FR 36635, Aug. 4, 2017; 84 FR 51831, Sept. 30, 2019] Subpart B—Special Requirements § 488.52 [Reserved] § 488.54 Temporary waivers applicable to hospitals. (a) General provisions. (1) The hospital is located in a rural area. This includes all areas not delineated as “urban” by the Bureau of the Census, based on the most recent census; (2) The hospital has 50 or fewer inpatient hospital beds; (3) The character and seriousness of the deficiencies do not adversely affect the health and safety of patients; and (4) The hospital has made and continues to make a good faith effort to comply with personnel requirements consistent with any waiver. (b) Minimum compliance requirements. (c) Temporary waiver of 24-hour nursing requirement of 24-hour registered nurse requirement. (1) The hospital's failure to comply fully with the 24-hour nursing requirement is attributable to a temporary shortage of qualified nursing personnel in the area in which the hospital is located. (2) A registered nurse is present on the premises to furnish or supervise the nursing services during at least the daytime shift, 7 days a week. (3) The hospital has in charge, on all tours of duty not covered by a registered nurse, a licensed practical (vocational) nurse. (4) The hospital complies with all requirements specified in paragraph (a) of this section. (d) Temporary waiver for technical personnel. [39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, and amended at 41 FR 27962, July 8, 1976. Further redesignated at 42 FR 52826, Sept. 30, 1977, and amended at 47 FR 31531, July 20, 1982; 51 FR 22041, June 17, 1986. Redesignated at 53 FR 23100, June 17, 1988] § 488.56 Temporary waivers applicable to skilled nursing facilities. (a) Waiver of 7-day registered nurse requirement. (1) Such facility is located in a rural area and the supply of skilled nursing facility services in such area is not sufficient to meet the needs of individual patients therein, (2) Such facility has at least one fulltime registered nurse who is regularly on duty at such facility 40 hours a week, and (3) Such facility (i) has only patients whose attending physicians have indicated (through physicians' orders or admission notes) that each such patient does not require the services of a registered nurse for a 48-hour period, or (ii) has made arrangements for a registered nurse or a physician to spend such time at the facility as is determined necessary by the patient's attending physician to provide necessary services on days when the regular fulltime registered nurse is not on duty. (4) Such facility has made and continues to make a good faith effort to comply with the more than 40-hour registered nurse requirement, but such compliance is impeded by the unavailability of registered nurses in the area. (b) Waiver of medical director requirement. (1) Such facility is located in an area where the supply of physicians is not sufficient to permit compliance with this requirement without seriously reducing the availability of physician services within the area, and (2) Such facility has made and continues to make a good faith effort to comply with § 483.70(h) of this chapter, but such compliance is impeded by the unavailability of physicians in the area. [39 FR 35777, Oct. 3, 1974. Redesignated and amended at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 53 FR 23100, June 17, 1988, and further amended at 56 FR 48879, Sept. 26, 1991; 57 FR 43925, Sept. 23, 1992; 81 FR 68871, Oct. 4, 2016; 82 FR 32260, July 13, 2017] § 488.60 Special procedures for approving end stage renal disease facilities. (a) Consideration for approval. (1) Certification by the State agency referred to in § 488.12 of this part. (2) Data furnished by ESRD network organizations and recommendations of the Public Health Service concerning the facility's contribution to the ESRD services of the network. (3) Data concerning the facility's compliance with professional norms and standards. (4) Data pertaining to the facility's qualifications for approval or for any expansion of services. (b) Determining compliance with minimal utilization rates: Time limitations Unconditional status. (2) Conditional status. (3) Exception status. (c) New applicant. (d) Notification. (e) Failure to meet minimal utilization rate. (f) Interim regulations participant. [41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated and amended at 53 FR 23100, June 17, 1988; 73 FR 20474, Apr. 15, 2008] § 488.61 Special procedures for approval and re-approval of organ transplant programs. For the purposes of this subpart, the survey, certification, and enforcement procedures described at 42 CFR part 488, subpart A apply to transplant programs, including the periodic review of compliance and approval described at § 488.20. (a) Initial approval procedures for transplant programs that are not Medicare-approved as of June 28, 2007. (1) The request, signed by a person authorized to represent the center (for example, a chief executive officer), must include: (i) The hospital's Medicare provider I.D. number; (ii) Name(s) of the designated primary transplant surgeon and primary transplant physician; and, (iii) A statement from the OPTN that the center has complied with all data submission requirements. (2) To determine compliance with the clinical experience and outcome requirements at §§ 482.80(b) and 482.80(c), CMS will review the data contained in the most recent OPTN Data Report and 1-year patient and graft survival data contained in the most recent Scientific Registry of Transplant Recipient (SRTR) program-specific report. (3) If CMS determines that a transplant center has not met the data submission, clinical experience, or outcome requirements, CMS may deny the request for approval or may review the center's compliance with the conditions of participation at §§ 482.72 through 482.76 and §§ 482.90 through 482.104 of this chapter, using the procedures described at 42 CFR part 488, subpart A, to determine whether the center's request will be approved. CMS will notify the transplant center in writing whether it is approved and, if approved, of the effective date of its approval. (4) CMS will consider mitigating factors in accordance with paragraphs (f), (g), and (h) of this section. (5) If CMS determines that a transplant program has met the data submission, clinical experience, and outcome requirements, CMS will review the program's compliance with the conditions of participation contained at §§ 482.72 through 482.76 and §§ 482.90 through 482.104 of this chapter using the procedures described in subpart A of this part. If the transplant program is found to be in compliance with all the conditions of participation at §§ 482.72 through 482.104 of this chapter, CMS will notify the transplant program in writing of the effective date of its Medicare-approval. CMS will notify the transplant program in writing if it is not Medicare-approved. (6) A kidney transplant center may submit a request for initial approval after performing at least 3 transplants over a 12-month period. (b) Initial approval procedures for transplant centers, including kidney transplant centers, that are Medicare approved as of June 28, 2007. (2) CMS will determine whether to approve the transplant center, using the procedures described in paragraphs (a)(2) through (a)(5) of this section. Until CMS makes a determination whether to approve the transplant center under the conditions of participation at §§ 482.72 through 482.104, the transplant center will continue to be Medicare approved under the end stage renal disease (ESRD) conditions for coverage (CfCs) in part 405, subpart U of this chapter for kidney transplant centers or the pertinent national coverage decisions (NCDs) for extra-renal organ transplant centers, as applicable, and the transplant center will continue to be reimbursed for services provided to Medicare beneficiaries. (3) Once CMS approves a kidney transplant center under the conditions of participation, the ESRD CfCs no longer apply to the center as of the date of its approval. Once CMS approves an extra-renal organ transplant center under the conditions of participation, the NCDs no longer apply to the center as of the date of its approval. (4) If a transplant center that is Medicare approved as of June 28, 2007 submits a request for approval under the CoPs at §§ 482.72 through 482.104 of this chapter but CMS does not approve the transplant center, or if the transplant center does not submit its request to CMS for Medicare approval under the CoPs by December 26, 2007, CMS will revoke the transplant center's approval under the conditions for coverage for kidney transplant centers or the national coverage decisions for extra-renal transplant centers, as applicable, and the transplant center will no longer be reimbursed for services provided to Medicare beneficiaries. CMS will notify the transplant center in writing of the effective date of its loss of Medicare approval. (c) Loss of Medicare approval. (1) Request initial approval using the procedures described in paragraph (a) of this section; (2) Be in compliance with §§ 482.72 through 482.104 of this chapter at the time of the request for Medicare approval; and (3) Submit a report to CMS documenting any changes or corrective actions taken by the program as a result of the loss of its Medicare approval status. (d) Transplant program inactivity. (e) Consideration of mitigating factors in initial approval survey, certification, and enforcement actions for transplant programs Factors. (i) The extent to which outcome measures are not met or exceeded; (ii) Availability of Medicare-approved transplant centers in the area; (iii) Extenuating circumstances (for example, natural disaster) that have a temporary effect on meeting the conditions of participation; (iv) Program improvements that substantially address root causes of graft failures or patient deaths, that have been implemented and institutionalized on a sustainable basis, and that are supported by outcomes more recent than the latest available SRTR report, for which there is a sufficient post-transplant patient and graft survival period and a sufficient number of transplants such that CMS finds that the program demonstrates present-day compliance with the requirements at § 482.80(c)(2)(ii)(C) of this chapter; (v) Whether the program has made extensive use of innovative transplantation practices relative to other transplant programs, such as a high rate of transplantation of individuals who are highly sensitized or children who have undergone a Fontan procedure compared to most other transplant programs, where CMS finds that the innovative practices are supported by evidence-based published research literature or nationally recognized standards or Institution Review Board (IRB) approvals, and the SRTR risk-adjustment methodology does not take the relevant key factors into consideration; and (vi) Whether the program's performance, based on the OPTN method of calculating patient and graft survival, is within the OPTN's thresholds for acceptable performance and does not flag OPTN performance review under the applicable OPTN policy. (2) Content. (i) The name and contact information for the transplant hospital and the names and roles of key personnel of the transplant program; (ii) The type of organ transplant program(s) for which approval is requested; (iii) The conditions of participation that the program does not meet for which the transplant center is requesting CMS' review for mitigating factors; (iv) The program's organizational chart with full-time equivalent levels, roles, and structure for reporting to hospital leadership; (v) For applications involving substandard patient or graft survival, the rationale and supporting evidence for CMS' review includes, but is not limited to— (A) Root Cause Analysis for patient deaths and graft failures, including factors the program has identified as likely causal or contributing factors for patient deaths and graft failures; (B) Program improvements that have been implemented and improvements that are planned; (C) Patient and donor/organ selection criteria and evaluation protocols, including methods for pre-transplant patient evaluation by cardiologists, hematologists, nephrologists, and psychiatrists or psychologists to the extent applicable; (D) Waitlist management protocols and practices relevant to outcomes; (E) Pre-operative management protocols and practices; (F) Immunosuppression/infection prophylaxis protocols; (G) Post-transplant monitoring and management protocols and practices; (H) Quality Assessment and Performance Improvement (QAPI) Program meeting minutes from the most recent four meetings and attendance rosters from the most recent 12 months; (I) Quality dashboard and other performance indicators; and (J) The most recent data regarding transplants that have been made and for outcomes in terms of both patient survival and graft survival; (vi) For mitigating factors requests based on innovative practice: (A) A description of the innovations that have been implemented and identification of the specific cases for which the innovative practices are relevant so as to enable the patient and graft survival data for such cases to be compared with all other transplants for at least the period covered by the latest available SRTR report. (B) The literature, research, or other evidentiary basis that supports consideration of the practice(s) as innovative. (vii) For requests based on natural disasters or public health emergency: (A) A description of the disaster or emergency, the specific impact on the program, the time periods of the event(s) and of its immediate recovery aftermath; (B) Identification of the transplants that occurred during the period for which the request is being made; and (C) The approximate date when the program believes it substantially recovered from the event(s), or believes it will recover if substantial recovery has not been accomplished at the time of the request. (3) Timing. (f) Results of mitigating factors review Actions. (i) Approve initial approval of a program's Medicare participation based upon approval of mitigating factors. (ii) Deny the program's request for Medicare approval based on mitigating factors. (iii) Offer a time-limited Systems Improvement Agreement, in accordance with paragraph (g) of this section, when a transplant program has waived its appeal rights, has implemented substantial program improvements that address root causes and are institutionally supported by the hospital's governing body on a sustainable basis, and has requested more time to design or implement additional improvements or demonstrate compliance with CMS outcome requirements. Upon completion of the Systems Improvement Agreement or a CMS finding that the hospital has failed to meet the terms of the Agreement, CMS makes a final determination of whether to approve or deny a program's request for Medicare approval based on mitigating factors. A Systems Improvement Agreement follows the process specified in paragraph (g) of this section. (2) Limitation. (g) Transplant Systems Improvement Agreement. (1) Content. (i) Patient notification about the degree and type of noncompliance by the program, an explanation of what the program improvement efforts mean for patients, and financial assistance to defray the out-of-pocket costs of copayments and testing expenses for any wait-listed individual who wishes to be listed with another program; (ii) An external independent peer review team that conducts an onsite assessment of the program. The peer review must include— (A) Review of policies, staffing, operations, relationship to hospital services, and factors that contribute to program outcomes; (B) Suggestions for quality improvements the hospital should consider; (C) Both verbal and written feedback provided directly to the hospital; (D) Verbal debriefing provided directly to CMS; neither the hospital nor the peer review team is required to provide a written report to CMS; and (E) Onsite review by a multidisciplinary team that includes a transplant surgeon with expertise in the relevant organ type(s), a transplant administrator, an individual with expertise in transplant QAPI systems, a social worker or psychologist or psychiatrist, and a specialty physician with expertise in conditions particularly relevant to the applicable organ types(s) such as a cardiologist, nephrologist, or hepatologist. Except for the transplant surgeon, CMS may permit substitution of one type of expertise for another individual who has expertise particularly needed for the type of challenges experienced by the program, such as substitution of an infection control specialist in lieu of, or in addition to, a social worker; (iii) An action plan that addresses systemic quality improvements and is updated after the onsite peer review; (iv) An onsite consultant whose qualifications are approved by CMS, and who provides services for 8 days per month on average for the duration of the agreement, except that CMS may permit a portion of the time to be spent offsite and may agree to fewer consultant days each month after the first 3 months of the Systems Improvement Agreement; (v) A comparative effectiveness analysis that compares policies, procedures, and protocols of the transplant program with those of other programs in areas of endeavor that are relevant to the center's current quality improvement needs; (vi) Development of increased proficiency, or demonstration of current proficiency, with patient-level data from the Scientific Registry of Transplant Recipients and the use of registry data to analyze outcomes and inform quality improvement efforts; (vii) A staffing analysis that examines the level, type, training, and skill of staff in order to inform transplant center efforts to ensure the engagement and appropriate training and credentialing of staff; (viii) Activities to strengthen performance of the Quality Assessment and Performance Improvement Program to ensure full compliance with the requirements of § 482.96 and § 482.21 of this chapter; (ix) Monthly (unless otherwise specified) reporting and conference calls with CMS regarding the status of programmatic improvements, results of the deliverables in the Systems Improvement Agreement, and the number of transplants, deaths, and graft failures that occur within 1 year post-transplant; and (x) Additional or alternative requirements specified by CMS, tailored to the transplant program type and circumstances. CMS may waive the content elements at paragraph (g)(1)(v), (vi), (vii) or (viii) of this section if it finds that the program has already adequately conducted the activity, the program is already proficient in the function, or the activity is clearly inapplicable to the deficiencies that led to the Agreement. (2) Timeframe. [72 FR 15278, Mar. 30, 2007, as amended at 79 FR 27156, May 12, 2014; 79 FR 50359, Aug. 22, 2014; 81 FR 79881, Nov. 14, 2016; 84 FR 51831, Sept. 30, 2019] § 488.64 Remote facility variances for utilization review requirements. (a) As used in this section: (1) An “available” individual is one who: (i) Possesses the necessary professional qualifications; (ii) Is not precluded from participating by reason of financial interest in any such facility or direct responsibility for the care of the patients being reviewed or, in the case of a skilled nursing facility, employment by the facility; and (iii) Is not precluded from effective participation by the distance between the facility and his residence, office, or other place of work. An individual whose residence, office, or other place of work is more than approximately one hour's travel time from the facility shall be considered precluded from effective participation. (2) “Adjacent facility” means a health care facility located within a 50-mile radius of the facility which requests a variance. (b) The Secretary may grant a requesting facility a variance from the time frames set forth in §§ 405.1137(d) of this chapter and 482.30 as applicable, within which reviews all of cases must be commenced and completed, upon a showing satisfactory to the Secretary that the requesting facility has been unable to meet one or more of the requirements of § 405.1137 of this chapter or § 482.30 of this chapter, as applicable, by reason of insufficient medical and other professional personnel available to conduct the utilization review required by § 405.1137 of this chapter or § 482.30 of this chapter, as applicable. (c) The request for variance shall document the requesting facility's inability to meet the requirements for which a variance is requested and the facility's good faith efforts to comply with the requirements contained in § 405.1137 of this chapter or § 482.30 of this chapter, as applicable. (d) The request shall include an assurance by the requesting facility that it will continue its good faith efforts to meet the requirements contained in § 405.1137 of this chapter or § 482.30 of this chapter, as applicable. (e) A revised utilization review plan for the requesting facility shall be submitted concurrently with the request for a variance. The revised plan shall specify the methods and procedures which the requesting facility will use, if a variance is granted, to assure: (1) That effective and timely control will be maintained over the utilization of services; and (2) That reviews will be conducted so as to improve the quality of care provided to patients. (f) The request for a variance shall include: (1) The name, location, and type (e.g., hospital, skilled nursing facility) of the facility for which the variance is requested; (2) The total number of patient admissions and average daily patient census at the facility within the previous six months; (3) The total number of title XVIII and title XIX patient admissions and the average daily patient census of title XVIII and title XIX patients in the facility within the previous six months; (4) As relevant to the request, the names of all physicians on the active staff of the facility and the names of all other professional personnel on the staff of the facility, or both; (5) The name, location, and type of each adjacent facility (e.g., hospital, skilled nursing facility); (6) The distance and average travel time between the facility and each adjacent facility; (7) As relevant to the request, the location of practice of available physicians and the estimated number of other available professional personnel, or both (see paragraph (a)(1)(iii) of this section); (8) Documentation by the facility of its attempt to obtain the services of available physicians or other professional personnel, or both; and (9) A statement of whether a QIO exists in the area where the facility is located. (g) The Secretary shall promptly notify the facility of the action taken on the request. Where a variance is in effect, the validation of utilization review pursuant to § 405.1137 of this chapter or § 482.30 shall be made with reference to the revised utilization review plan submitted with the request for variance. (h) The Secretary, in granting a variance, will specify the period for which the variance has been granted; such period will not exceed one year. A request for a renewal shall be submitted not later than 30 days prior to the expiration of the variance and shall contain all information required by paragraphs (c), (d), and (f) of this section. Renewal of the variance will be contingent upon the facility's continuing to meet the provisions of this section. [40 FR 30818, July 23, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977; 51 FR 22041, June 17, 1986; 51 FR 27847, Aug. 4, 1986; 51 FR 43197, Dec. 1, 1986. Redesignated and amended at 53 FR 23100, June 17, 1988] § 488.68 State Agency responsibilities for OASIS collection and data base requirements. As part of State agency survey responsibilities, the State agency or other entity designated by CMS has overall responsibility for fulfilling the following requirements for operating the OASIS system: (a) Establish and maintain an OASIS database. (1) Use a standard system developed or approved by CMS to collect, store, and analyze data; (2) Conduct basic system management activities including hardware and software maintenance, system back-up, and monitoring the status of the database; and (3) Obtain CMS approval before modifying any parts of the CMS standard system including, but not limited to, standard CMS-approved— (i) OASIS data items; (ii) Record formats and validation edits; and (iii) Agency encoding and transmission methods. (b) Analyze and edit OASIS data. (1) Upon receipt of data from an HHA, edit the data as specified by CMS and ensure that the HHA resolves errors within the limits specified by CMS; (2) At least monthly, make available for retrieval by CMS all edited OASIS records received during that period, according to formats specified by CMS, and correct and retransmit previously rejected data as needed; and (3) Analyze data and generate reports as specified by CMS. (c) Ensure accuracy of OASIS data. (d) Restrict access to OASIS data. (1) Ensure that access to data is restricted except for the transmission of data and reports to— (i) CMS; (ii) The State agency component that conducts surveys for purposes related to this function; and (iii) Other entities if authorized by CMS. (2) Ensure that patient identifiable OASIS data is released only to the extent that it is permitted under the Privacy Act of 1974. (e) Provide training and technical support for HHAs. (1) Instruct each HHA on the administration of the data set, privacy/confidentiality of the data set, and integration of the OASIS data set into the facility's own record keeping system; (2) Instruct each HHA on the use of software to encode and transmit OASIS data to the State; (3) Specify to a facility the method of transmission of data to the State, and instruct the facility on this method. (4) Monitor each HHA's ability to transmit OASIS data. (5) Provide ongoing technical assistance and general support to HHAs in implementing the OASIS reporting requirements specified in the conditions of participation for home health agencies; and (6) Carry out any other functions as designated by CMS necessary to maintain OASIS data on the standard State system. [64 FR 3763, Jan. 25, 1999] § 488.70 Special requirements for rural emergency hospitals (REHs). An eligible facility submitting an application for enrollment under section 1866(j) of the Act to become a rural emergency hospital (REH) (as defined in § 485.502 of this chapter) must also submit an action plan containing the following additional information: (a) Plan for provision of services. (b) Transition plan. (c) Other outpatient medical and health services. (d) Use of additional facility payment. [88 FR 59335, Aug. 28, 2023] Subpart C—Survey Forms and Procedures § 488.100 Long term care survey forms, Part A. § 488.105 Long term care survey forms, Part B. § 488.110 Procedural guidelines. SNF/ICF Survey Process. The Outcome-Oriented Survey Process—Skilled Nursing Facilities (SNFs) and Intermediate Care Facilities (ICFs) (a) General. (b) The Survey Tasks. (c) Task 1—Entrance Conference. (d) Task 2—Resident Sample—Selection Methodology. (e) Task 3—Tour of the Facility. (f) Task 4—Observation/Interview/Medical Record Review (including drug regimen review). (g) Task 5—Drug Pass Observation. (h) Task 6—Dining Area and Eating Assistance Observation. (i) Task 7—Forming the Deficiency Statement. (j) Task 8—Exit Conference. (k) Plan of Correction. (l) Followup Surveys. (m) Role of Surveyor. (n) Confidentiality and Respect for Resident Privacy. (o) Team Composition. (p) Type of Facility-Application of SNF or ICF Regulations. (q) Use of Part A and Part B of the Survey Report. (a) General. • Life Safety Code requirements; • Administrative and structural requirements (Part A of the Survey Report, Form CMS-525); and • Direct resident care requirements (Part B of the Survey Report, Form CMS-519), along with the related worksheets (CMS-520 through 524). Use this survey process for all surveys of SNFs and ICFs—whether freestanding, distinct parts, or dually certified. Do not use this process for surveys of Intermediate Care Facilities for Mentally Retarded (ICFs/IID), swing-bed hospitals or skilled nursing sections of hospitals that are not separately certified as SNF distinct parts. Do not announce SNF/ICF surveys ahead of time. (b) The Survey Tasks. • Task 1. Entrance Conference. • Task 2. Resident Sample—Selection Methodology. • Task 3. Tour of the Facility. Resident Needs. Physical Environment. Meeting with Resident Council Representatives. Tour Summation and Focus of Remaining Survey Activity. • Task 4. Observation/Interview/Medical Record. Review of Each Individual in the Resident Sample (including drug regimen review). • Task 5. Drug Pass Observation. • Task 6. Dining Area and Eating Assistance Observation. • Task 7. Forming the Deficiency Statement (if necessary). • Task 8. Exit Conference. (c) Task 1 Entrance Conference. • Introduce all members of the team to the facility staff, if possible, even though the whole team may not be present for the entire entrance conference. (All surveyors wear identification tags.) • Explain the SNF/ICF survey process as resident centered in focus, and outline the basic steps. • Ask the facility for a list showing names of residents by room number with each of the following care needs/treatments identified for each resident to whom they apply: —Decubitus care —Restraints —Catheters —Injections —Parenteral fluids —Rehabilitation service —Colostomy/ileostomy care —Respiratory care —Tracheostomy care —Suctioning —Tube feeding Use this list for selecting the resident sample. • Ask the facility to complete page 2 of Form CMS-519 (Resident Census) as soon as possible, so that the information can further orient you to the facility's population. In a survey of a SNF with a distinct part ICF, you may collect two sets of census data. However, consolidate the information when submitting it to the regional office. You may modify the Resident Census Form to include the numbers of licensed and certified beds, if necessary. • Ask the facility to post signs on readily viewed areas (at least one on each floor) announcing that State surveyors are in the facility performing an “inspection,” and are available to meet with residents in private. Also indicate the name and telephone number of the State agency. Hand-printed signs with legible, large letters are acceptable. • If the facility has a Resident Council, make mutually agreeable arrangements to meet privately with the president and officers and other individuals they might invite. • Inform the facility that interviews with residents and Resident Councils are conducted privately, unless they independently request otherwise, in order to enhance the development of rapport as well as to allay any resident anxiety. Tell the facility that information is gathered from interviews, the tour, observations, discussions, record review, and facility officials. Point out that the facility will be given an opportunity to respond to all findings. (d) Task 2 Resident Sample Selection Methodology. Primarily performed on a random basis, it also ensures representation in the sample of certain care needs and treatments that are assessed during the survey. (1) Sample Size. Number of residents in facility Number of residents in sample 1 0-60 residents 25% of residents (minimum—10). 61-120 residents 20% of residents (minimum—15). 121-200 residents 15% of residents (minimum—24). 201 + residents 10% of residents (minimum—30). 1 Note that the calculation is based on the resident census, not beds. After determining the appropriate sample size, select residents for the sample in a random manner. You may, for example, select every fifth resident from the resident census, beginning at a random position on the list. For surveys of dually certified facilities or distinct part SNFs/ICFs, first use the combined SNF/ICF population to calculate the size of the sample, and then select a sample that reflects the proportions of SNF and ICF residents in the facility's overall population. (2) Special Care Needs/Treatments. • Decubitus Care • Restraints • Catheters • Injections, Parenteral Fluids, Colostomy/Ileostomy, Respiratory Care, Tracheostomy Care, Suctioning, Tube Feeding • Rehabilitative Services (physical therapy, speech pathology and audiology services, occupational therapy) Due to the relatively low prevalence of these care needs/treatments, appropriate residents may be either under- represented or entirely omitted from the sample. Therefore, determine during the tour how many residents in the random selection fall into each of these care categories. Then, compare the number of such residents in the random selection with the total number of residents in the facility with each specified care need/treatment (based on either the resident census or other information provided by the facility). Review no less than 25 percent of the residents in each of these special care needs/treatments categories. For example, if the facility has 10 residents with decubitus ulcers, but only one of these residents is selected randomly, review two more residents with decubitis ulcers (25% of 10 equals 2.5, so review a total of 3). Or, if the facility has two residents who require tube feeding, neither of whom is in the random selection, review the care of at least one of the these residents. This can be accomplished in the following manner: Conduct in-depth reviews of the randomly selected residents and then perform limited reviews of additional residents as needed to cover the specified care categories. Such reviews are limited to the care and services related to the pertinent care areas only, e.g., catheters, restraints, or colostomy. Utilize those worksheets or portions of worksheets which are appropriate to the limited review. Refer to the Care Guidelines, as a resource document, when appropriate. Always keep in mind that neither the random selection approach nor the review of residents within the specified care categories precludes investigation of other resident care situations that you believe might pose a serious threat to a resident's health or safety. Add to the sample, as appropriate. (e) Task 3 Tour of the Facility Purpose. • Develop an overall picture of the types and patterns of care delivery present within the facility; • View the physical environment; and • Ascertain whether randomly selected residents are communicative and willing to be interviewed. (2) Protocol. Allow approximately three hours for the tour. Converse with residents, family members/significant others (if present), and staff, asking open-ended questions in order to confirm observations, obtain additional information, or corroborate information, (e.g., accidents, odors, apparent inappropriate dress, adequacy and appropriateness of activities). Converse sufficiently with residents selected for in-depth review to ascertain whether they are willing to be interviewed and are communicative. Observe staff interactions with other staff members as well as with residents for insight into matters such as resident rights and assignments of staff responsibilities. Always knock and/or get permission before entering a room or interrupting privacy. If you wish to inspect a resident's skin, observe a treatment procedure, or observe a resident who is exposed, courteously ask permission from the resident if she/he comprehends, or ask permission from the staff nurse if the resident cannot communicate. Do not do “hands-on” monitoring such as removal of dressings; ask staff to remove a dressing or handle a resident. (3) Resident Needs. —Personal hygiene, grooming, and appropriate dress —Position —Assistive and other restorative devices —Rehabilitation issues —Functional limitations in ADL —Functional limitations in gait, balance and coordination —Hydration and nutritional status —Resident rights —Activity for time of day (appropriate or inappropriate) —Emotional status —Level of orientation —Awareness of surroundings —Behaviors —Cleanliness of immediate environment (wheelchair, bed, bedside table, etc.) —Odors —Adequate clothing and care supplies as well as maintenance and cleanliness of same (4) Review of the Physical Environment. (5) Meeting With Resident Council Representatives. Use this meeting to ascertain strengths and/or problems, if any, from the consumer's perspective, as well as to develop additional information about aspects of care and services gleaned during the tour that were possibly substandard. Conduct the meeting in a manner that allows for comments about any aspect of the facility. (See the section on Interview Procedures.) Use open-ended questions such as: • “What is best about this home?” • “What is worst?” • “What would you like to change?” In order to get more detail, use questions such as: • “Can you be more specific?” • “Can you give me an example?” • “What can anyone else tell me about this?” If you wish to obtain information about a topic not raised by the residents, use an approach like the following: • “Tell me what you think about the food/staff/cleanliness here.” • “What would make it better?” • “What don't you like? What do you like?” (6) Tour Summation and Focus of Remaining Survey Activity. Transcribe notes of a negative nature onto the SRF in the “Remarks” column under the appropriate rule. Findings from a later segment in the survey or gathered by another surveyor may combine to substantiate a deficiency. You need not check “met” or “not met” at this point in the survey. Discuss significant impressions/conclusions at the completion of each subsequent survey task, and transfer any negative findings onto the Survey Report Form in the Remarks section. (f) Task 4 Observation/Interview/Medical Record Review (including drug regimen review). (1) Observation. Bowel and bladder training Catheter care Restraints Injections Parenteral fluids Tube feeding/gastrostomy Colostomy/ileostomy Respiratory therapy Tracheostomy care Suctioning (2) Interviews. At each interview: • Introduce yourself. • Address the resident by name. • Explain in simple terms the reason for your visit (e.g., to assure that the care and services are adequate and appropriate for each resident). • Briefly outline the process—entrance conference, tour, interviews, observations, review of medical records, resident interviews, and exit conference. • Mention that the selection of a particular resident for an interview is not meant to imply that his/her care is substandard or that the facility provides substandard care. Also mention that most of those interviewed are selected randomly. • Assure that you will strive for anonymity for the resident and that the interview is used in addition to medical records, observations, discussions, etc., to capture an accurate picture of the treatment and care provided by the facility. Explain that the official findings of the survey are usually available to the public about three months after completion of the survey, but resident names are not given to the public. • When residents experience difficulty expressing themselves: —Avoid pressuring residents to verbalize —Accept and respond to all communication —Ignore mistakes in word choice —Allow time for recollection of words —Encourage self-expression through any means available • When interviewing residents with decreased receptive capacity: —Speak slowly and distinctly —Speak at conversational voice level —Sit within the resident's line of vision • Listen to all resident information/allegations without judgment. Information gathered subsequently may substantiate or repudiate an allegation. The length of the interview varies, depending on the condition and wishes of the resident and the amount of information supplied. Expect the average interview, however, to last approximately 15 minutes. Courteously terminate an interview whenever the resident is unable or unwilling to continue, or is too confused or disoriented to continue. Do, however, perform the other activities of this task (observation and record review). If, in spite of your conversing during the tour, you find that less than 40 percent of the residents in your sample are sufficiently alert and willing to be interviewed, try to select replacements so that a complete OIRR is performed for a group this size, if possible. There may be situations, however, where the resident population has a high percentage of confused individuals and this percentage is not achievable. Expect that the information from confused individuals can be, but is not necessarily, less reliable than that from more alert individuals. Include the following areas in the interview of each resident in the sample: Activities of daily living Grooming/hygiene Nutrition/dietary Restorative/rehabilitation care and services Activities Social services Resident rights Refer to the Care Guidelines “evaluation factors” as a resource for possible elements to consider when focusing on particular aspects of care and resident needs. Document information obtained from the interviews/observations on the OIRR Worksheet. Record in the “Notes” section any additional information you may need in connection with substandard care or services. Unless the resident specifically requests that he/she be identified, do not reveal the source of the information gleaned from the interview. (3) Medical Record Review. Document your findings on the OIRR Worksheet, as appropriate, and summarize on the Survey Report Form the findings that are indicative of problematic or substandard care. Be alert for repeated similar instances of substandard care developing as the number of completed OIRR Worksheets increases. Note: The problems related to a particular standard or condition could range from identical (e.g., meals not in accordance with dietary plan) to different but related (e.g., nursing services—lapse in care provided to residents with catheters, to residents with contractures, to residents needing assistance for personal hygiene and residents with improperly applied restraints). (i) Reconciling the observation/interview findings with the record. • An assessment has been performed. • A plan with goals has been developed. • The interventions have been carried out. • The resident has been evaluated to determine the effectiveness of the interventions. For example, if a resident has developed a decubitus ulcer while in the facility, record review can validate staff and resident interviews regarding the facility's attempts at prevention. Use your own judgment; review as much of the record(s) as necessary to evaluate the care planning. Note that facilities need not establish specific areas in the record stating “Assessment,” “Plan,” “Intervention,” or “Evaluation” in order for the documentation to be considered adequate. (ii) Reconciling the record with itself. • If the resident has been properly assessed for all his/her needs. • That normal and routine nursing practices such as periodic weights, temperatures, blood pressures, etc., are performed as required by the resident's conditions. (iii) Performing the drug regimen review. Note: If you detect irregularities and the documentation demonstrates that the pharmacist has notified the attending physician, do not cite a deficiency. Do, however, bring the irregularity to the attention of the medical director or other facility official, and note the official's name and date of notification on the Survey Report Form. (g) Task 5—Drug Pass Observation. Transfer findings noted on the “Drug Pass” worksheet to the SRF under the appropriate rule. If your team concludes that the facility's medication error rate is 5 percent or more, cite the deficiency under Nursing Services/Administration of Drugs. Report the error rate under F209. If the deficiency is at the standard level, cite it in Nursing Services, rather than Pharmacy. (h) Task 6—Dining Area and Eating Assistance Observation. For this task, use the worksheet entitled “Dining Area and Eating Assistance Observation” (Form CMS-523). Observe two meals; for a balanced view, try to observe meals at different times of the day. For example, try to observe a breakfast and a dinner rather than two breakfasts. Give particular care to performing observations as unobtrusively as possible. Chatting with residents and sitting down nearby may help alleviate resident anxiety over the observation process. Select a minimum of five residents for each meal observation and include residents who have their meals in their rooms. Residents selected for the in-depth review need not be included in the dining and eating assistance observation; however, their whole or partial inclusion is acceptable. Ascertain the extent to which the facility assesses, plans, and evaluates the nutritional care of residents and eating assistance needs by reviewing the sample of 10 or more residents. If you are unable to determine whether the facility meets the standards from the sample reviewed, expand the sample and focus on the specific area(s) in question, until you can formulate a conclusion about the extent of compliance. As with the other survey tasks, transfer the findings noted on the “Dining & Eating Assistance Observation” worksheet to the Survey Report Form. (i) Task 7—Forming the Deficiency Statement General. Meet as a group in a pre-exit conference to discuss the findings and make conclusions about the deficiencies, subject to information provided by facility officials that may further explain the situation. Review the summaries/conclusions from each task and decide whether any further information and/or documentation is necessary to substantiate a deficiency. As the facility for additional information for clarification about particular findings, if necessary. Always consider information provided by the facility. If the facility considers as acceptable, practices which you believe are not acceptable, ask the facility to backup its contention with suitable reference material or sources and submit them for your consideration. (2) Analysis. Combinations of substandard care such as poor grooming of a number of residents, lack of ambulation of a number of residents, lack of attention to positioning, poor skin care, etc., can yield a deficiency in nursing services just as 10 out of 10 residents receiving substandard care for decubiti yields a deficiency. (3) Deficiencies Alleged by Staff or Residents. (4) Composing the Deficiency Statement. F102 SNF 405.1123(b). When the data prefix tag does not repeat the regulations, also include a short phrase that describes the prefix tag (e.g., F117 decubitus ulcer care). List the data tags in numerical order, whenever possible. (j) Task 8—Exit Conference. (k) Plan of Correction. • Does the facility have a reasonable approach for correcting the deficiencies? • Is there a high probability that the planned action will result in compliance? • Is compliance expected timely? Plans of correction specific to residents identified on the deficiency statement are acceptable only where the deficiency is determined to be unique to that resident and not indicative of a possible systemic problem. For example, as a result of an aide being absent, two residents are not ambulated three times that day as called for in their care plans. A plan of correction that says “Ambulate John Jones and Mary Smith three times per day,” is not acceptable. An acceptable plan of correction would explain changes made to the facility's staffing and scheduling in order to gurantee that staff is available to provide all necessary services for all residents. Acceptance of the plan of correction does not absolve the facility of the responsibility for compliance should the implementation not result in correction and compliance. Acceptance indicates the State agency's acknowledgement that the facility indicated a willingness and ability to make corrections adequately and timely. Allow the facility up to 10 days to prepare and submit the plan of correction to the State agency, however, follow your SA policy if the timeframe is shorter. Retain the various survey worksheets as well as the Survey Report Form at the State agency. Forward the deficiency statement to the CMS regional office. (l) Follow-up Surveys. When selecting the resident sample for the follow-up, determine the sample size using the same formula as used earlier in the survey, with the following exceptions: • The maximum sample size is 30 residents, rather than 50. • The minimum sample size of 10 residents does not apply if only one care category was cited as deficient and the total number of residents in the facility in that category was less than 10 (e.g., deficiency cited under catheter care and only five residents have catheters). Include in the sample those residents who, in your judgment, are appropriate for reviewing vis-a-vis the cited substandard care. If possible, include some residents identified as receiving substandard care during the initial survey. If after completing the follow-up activities you determine that the cited deficiencies were not corrected, initiate adverse action procedures, as appropriate. (m) Role of Surveyor. When you find substandard care or services in the course of a survey, carefully document your findings. Explain the deficiency in sufficient detail so that the facility officials understand your rationale. If the cause of the deficiency is obvious, share the information with the provider. For example, if you cite a deficiency for restraints (F118), indicate that restraints were applied backwards on residents 1621, 1634, 1646, etc. In those instances where the cause is not obvious, do not delve into the facility's policies and procedures to determine the root cause of any deficiency. Do not recommend or prescribe an acceptable remedy. The provider is responsible for deciding on and implementing the action(s) necessary for achieving compliance. For the restraint situation in the example above, you would not ascertain whether the improper application was due to improper training or lack of training, nor would you attempt to identify the staff member who applied the restraints. It is the provider's responsibility to make the necessary changes or corrections to ensure that the restriants are applied properly. A secondary role for the surveyor is to provide general consultation to the provider/consumer community. This includes meeting with provider/consumer associations and other groups as well as participating in seminars. It also includes informational activities, whereby you respond to oral or written inquiries about required outcomes in care and services. (n) Confidentiality and Respect for Resident Privacy. When communicating to the facility about substandard care, fully identify the resident(s) by name if the situation was identified through observation or record review. Improperly applied restraints, expired medication, cold food, gloves not worn for a sterile procedure, and diet inconsistent with order, are examples of problems which can be identified to the facility by resident name. Information about injuries due to broken equipment, prolonged use of restraints, and opened mail is less likely to be obtained through observation or record review. Do not reveal the source of information unless actually observed, discovered in the record review, or requested by the resident or family. (o) Team Composition. SNF/ICF Survey Team Model In facilities with 200 beds or less, the team size may range from 2 to 4 members. If the team size is: • 2 members: • 3-4 member: If the facility has over 200 beds and Average onsite time per survey: 60 person hours (Number of surveyors multiplied by the number of hours on site) Preferably, team members have gerontological training and experience. Any member may serve as the team leader, consistent with State agency procedures. In followup surveys, select disciplines based on major areas of correction. Include a social worker, for example, if the survey revealed major psychosocial problems. This model does not consider integrated survey and Inspection of Care review teams, which typically would be larger. (p) Type of Facility Application of SNF or ICF Regulations. • Freestanding Skilled Nursing Facility (SNF) Apply SNF regulations. • Freestanding Intermediate Care Facility (ICF) Apply ICF regulations. • SNF Distinct Part of a Hospital Apply SNF regulations. • ICF Distinct Part of a Hospital Apply ICF regulations. • Dually Certified SNF/ICF Apply SNF regulations and 442.346(b). • Freestanding SNF with ICF Distinct Part (Regardless of the proportion of SNF and ICF beds, the facility type is determined by the higher level of care. Therefore, LTC facilities with distinct parts are defined as SNFs with ICF distinct parts.) Apply SNF regulations for SNF unit. (q) Use of Part A and Part B of the Survey Report Use of Part A (CMS-525). • When a terminated facility requests program participation 60 days or more after termination. Treat this situation as a request for initial certification and complete Part A of the survey report in addition to Part B. • If an ICF with a favorable compliance history requests to covert a number of beds to SNF level, complete both Part A and Part B for compliance with the SNF requirements. If distinct part status is at issue, also examine whether it meets the criteria for certification as a distinct part. (i) Addendum for Outpatient Physical Therapy (OPT) or Speech Pathology Services. (ii) Resurvey of Participating Facilities. (iii) Substantial Changes in a Facility's Organization and Management. (2) Use of Part B (CMS-519). The worksheets are: • CMS-520—Residents Selected for Indepth Review • CMS-521—Tour Notes Worksheet • CMS-522—Drug Pass Worksheet • CMS-523—Dining Area and Eating Assistance Worksheet • CMS-5245—Observation/Interview/Record Review Worksheet For complaint investigations, perform a full or partial Part B survey based on the extent of the allegations. If the complaint alleges substandard care in a general fashion or in a variety of services and care areas, perform several tasks or a full Part B survey, as needed. If the complaint is of a more specific nature, such as an allegation of improper medications, perform an appropriate partial Part B survey, such as a drug pass review and a review of selected medical records. § 488.115 Care guidelines. Subpart D—Reconsideration of Adverse Determinations—Deeming Authority for Accreditation Organizations and CLIA Exemption of Laboratories Under State Programs Source: 57 FR 34012, July 31, 1992, unless otherwise noted. § 488.201 Reconsideration. (a) Right to reconsideration. (2) A State dissatisfied with a determination that the requirements it imposes on laboratories in that State and under the laws of that State do not provide (or do not continue to provide) reasonable assurance that laboratories licensed or approved by the State meet applicable CLIA requirements is entitled to a reconsideration as provided in this subpart. (b) Eligibility for reconsideration. (c) Manner and timing of request for reconsideration. (2) Reconsideration procedures are available after the effective date of the decision to deny, remove, or not renew the approval of an accreditation organization or State laboratory program. (d) Content of request. [57 FR 34012, July 31, 1992, as amended at 58 FR 61843, Nov. 23, 1993] § 488.203 Withdrawal of request for reconsideration. A requestor may withdraw its request for reconsideration at any time before the issuance of a reconsideration determination. § 488.205 Right to informal hearing. In response to a request for reconsideration, CMS will provide the accreditation organization or the State laboratory program the opportunity for an informal hearing as described in § 488.207 that will— (a) Be conducted by a hearing officer appointed by the Administrator of CMS; and (b) Provide the accreditation organization or State laboratory program the opportunity to present, in writing or in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew deeming authority or the exemption of a State's laboratories from CLIA requirements. § 488.207 Informal hearing procedures. (a) CMS will provide written notice of the time and place of the informal hearing at least 10 days before the scheduled date. (b) The informal reconsideration hearing will be conducted in accordance with the following procedures— (1) The hearing is open to CMS and the organization requesting the reconsideration, including— (i) Authorized representatives; (ii) Technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts); and (iii) Legal counsel; (2) The hearing is conducted by the hearing officer who receives testimony and documents related to the proposed action; (3) Testimony and other evidence may be accepted by the hearing officer even though it would be inadmissable under the usual rules of court procedures; (4) Either party may call witnesses from among those individuals specified in paragraph (b)(1) of this section; and (5) The hearing officer does not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. § 488.209 Hearing officer's findings. (a) Within 30 days of the close of the hearing, the hearing officer will present the findings and recommendations to the accreditation organization or State laboratory program that requested the reconsideration. (b) The written report of the hearing officer will include— (1) Separate numbered findings of fact; and (2) The legal conclusions of the hearing officer. § 488.211 Final reconsideration determination. (a) The hearing officer's decision is final unless the Administrator, within 30 days of the hearing officer's decision, chooses to review that decision. (b) The Administrator may accept, reject or modify the hearing officer's findings. (c) Should the Administrator choose to review the hearing officer's decision, the Administrator will issue a final reconsideration determination to the accreditation organization or State laboratory program on the basis of the hearing officer's findings and recommendations and other relevant information. (d) The reconsideration determination of the Administrator is final. (e) A final reconsideration determination against an accreditation organization or State laboratory program will be published by CMS in the Federal Register. Subpart E—Survey and Certification of Long-Term Care Facilities Source: 59 FR 56238, Nov. 10, 1994, unless otherwise noted. § 488.300 Statutory basis. Sections 1819 and 1919 of the Act establish requirements for surveying SNFs and NFs to determine whether they meet the requirements for participation in the Medicare and Medicaid programs. § 488.301 Definitions. As used in this subpart— Abbreviated standard survey Abuse Willful, Deficiency Dually participating facility Extended survey Facility Immediate family Immediate jeopardy Misappropriation of resident property Neglect Noncompliance Nurse aide Nursing facility (NF) Paid feeding assistant Partial extended survey Skilled nursing facility (SNF) Standard survey Substandard quality of care Substantial compliance Validation survey [59 FR 56238, Nov. 10, 1994, as amended at 68 FR 55539, Sept. 26, 2003; 81 FR 68871, Oct. 4, 2016; 82 FR 36635, Aug. 4, 2017] § 488.303 State plan requirement. (a) A State plan must provide that the requirements of this subpart and subpart F of this part are met, to the extent that those requirements apply to the Medicaid program. (b) A State may establish a program to reward, through public recognition, incentive payments, or both, nursing facilities that provide the highest quality care to Medicaid residents. For purposes of section 1903(a)(7) of the Social Security Act, proper expenses incurred by a State in carrying out such a program are considered to be expenses necessary for the proper and efficient administration of the State plan. (c) A State must conduct periodic educational programs for the staff and residents (and their representatives) of NFs in order to present current regulations, procedures, and policies under this subpart and subpart F of this part. (d) Required remedies for a non-State operated NF. A State must establish, in addition to termination of the provider agreement, the following remedies or an approved alternative to the following remedies for imposition against a non-State operated NF: (1) Temporary management. (2) Denial of payment for new admissions. (3) Civil money penalties. (4) Transfer of residents. (5) Closure of the facility and transfer of residents. (6) State monitoring. (e) Optional remedies for a non-State operated NF. A State may establish the following remedies for imposition against a non-State operated NF: (1) Directed plan of correction. (2) Directed in-service training. (3) Alternative or additional State remedies. (f) Alternative or additional State remedies. If a State uses remedies that are in addition to those specified in paragraph (d) or (e) of this section, or alternative to those specified in paragraph (d) of this section (other than termination of participation), it must— (1) Specify those remedies in the State plan; and (2) Demonstrate to CMS's satisfaction that those alternative remedies are as effective in deterring noncompliance and correcting deficiencies as the remedies listed in paragraphs (d) and (e) of this section. [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] § 488.305 Standard surveys. (a) For each SNF and NF, the State survey agency must conduct standard surveys that include all of the following: (1) A case-mix stratified sample of residents; (2) A survey of the quality of care furnished, as measured by indicators of medical, nursing, and rehabilitative care, dietary and nutrition services, activities and social participation, and sanitation, infection control, and the physical environment; (3) An audit of written plans of care and residents' assessments to determine the accuracy of such assessments and the adequacy of such plans of care; and (4) A review of compliance with residents' rights requirements set forth in sections 1819(c) and 1919(c) of the Act. (b) The State survey agency's failure to follow the procedures set forth in this section will not invalidate otherwise legitimate determinations that a facility's deficiencies exist. § 488.307 Unannounced surveys. (a) Basic rule. (b) Review of survey agency's scheduling and surveying procedures. (2) CMS takes corrective action in accordance with the nature and complexity of the problem when survey agencies are found to have notified a SNF or NF through their scheduling or procedural policies. Sanctions for inadequate survey performance are in accordance with § 488.320. (c) Civil money penalties. [59 FR 56238, Nov. 10, 1994, as amended at 81 FR 61563, Sept. 6, 2016] § 488.308 Survey frequency. (a) Basic period. (b) Statewide average interval. (2) CMS takes corrective action in accordance with the nature of the State survey agency's failure to ensure that the 12-month statewide average interval requirement is met. CMS's corrective action is in accordance with § 488.320. (c) Other surveys. (1) Determine whether a facility complies with the participation requirements; and (2) Confirm that the facility has corrected deficiencies previously cited. (d) Computation of statewide average interval. (e) Special surveys. (i) Ownership; (ii) Entity responsible for management of a facility (management firm); (iii) Nursing home administrator; or (iv) Director of nursing. (2) [Reserved] (f) Investigation of complaints. (i) A deficiency in one or more of the requirements may have occurred; and (ii) Only a survey can determine whether a deficiency or deficiencies exist. (2) The survey agency does not conduct a survey if the complaint raises issues that are outside the purview of Federal participation requirements. [53 FR 22859, June 17, 1988, as amended at 82 FR 36635, Aug. 4, 2017] § 488.310 Extended survey. (a) Purpose of survey. (b) Scope of extended survey. (1) Review of a larger sample of resident assessments than the sample used in a standard survey. (2) Review of the staffing and in-service training. (3) If appropriate, examination of the contracts with consultants. (4) A review of the policies and procedures related to the requirements for which deficiencies exist. (5) Investigation of any participation requirement at the discretion of the survey agency. (c) Timing and basis for survey. § 488.312 Consistency of survey results. CMS does and the survey agency must implement programs to measure accuracy and improve consistency in the application of survey results and enforcement remedies. § 488.314 Survey teams. (a) Team composition. (2) Examples of professionals include, but are not limited to, physicians, physician assistants, nurse practitioners, physical, speech, or occupational therapists, registered professional nurses, dieticians, sanitarians, engineers, licensed practical nurses, or social workers. (3) The State determines what constitutes a professional, subject to CMS approval. (4) Any of the following circumstances disqualifies a surveyor for surveying a particular facility: (i) The surveyor currently works, or, within the past two years, has worked as an employee, as employment agency staff at the facility, or as an officer, consultant, or agent for the facility to be surveyed. (ii) The surveyor has any financial interest or any ownership interest in the facility. (iii) The surveyor has an immediate family member who has a relationship with a facility described in paragraphs (a)(4)(i) or paragraph (a)(4)(ii) of this section. (iv) The surveyor has an immediate family member who is a resident in the facility to be surveyed. For purposes of this section, an immediate family member is defined at § 488.301 of this part. (b) CMS training. (1) Application and interpretation of regulations for SNFs and NFs. (2) Techniques and survey procedures for conducting standard and extended surveys. (3) Techniques for auditing resident assessments and plans of care. (c) Required surveyor training. (2) The survey agency must have a mechanism to identify and respond to in-service training needs of the surveyors. (3) The survey agency may permit an individual who has not completed a training program to participate in a survey as a trainee if accompanied on-site by a surveyor who has successfully completed the required training and testing program. [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995 as amended at 82 FR 36636, Aug. 4, 2017] § 488.318 Inadequate survey performance. (a) CMS considers survey performance to be inadequate if the State survey agency— (1) Indicates a pattern of failure to— (i) Identify deficiencies and the failure cannot be explained by changed conditions in the facility or other case specific factors; (ii) Cite only valid deficiencies; (iii) Conduct surveys in accordance with the requirements of this subpart; or (iv) Use Federal standards, protocols, and the forms, methods and procedures specified by CMS in manual instructions; or (2) Fails to identify an immediate jeopardy situation. (b) Inadequate survey performance does not— (1) Relieve a SNF or NF of its obligation to meet all requirements for program participation; or (2) Invalidate adequately documented deficiencies. § 488.320 Sanctions for inadequate survey performance. (a) Annual assessment of survey performance. (b) Sanctions for inadequate survey performance. (c) Medicaid facilities. (i) Reduces FFP, as specified in paragraph (e) of this section, and if appropriate; (ii) Provides for training of survey teams. (2) For other survey inadequacies in Medicaid facilities, CMS provides for training of survey teams. (d) Medicare facilities. (1) Requires that the State survey agency submit a plan of correction; (2) Provides for training of survey teams; (3) Provides technical assistance on scheduling and procedural policies; (4) Provides CMS-directed scheduling; or (5) Initiates action to terminate the agreement between the Secretary and the State under section 1864 of the Act, either in whole or in part. (e) Reduction of FFP. (1) The numerator of which is equal to the total number of residents in the NFs that CMS found to be noncompliant during validation surveys for that quarter; and (2) The denominator of which is equal to the total number of residents in the NFs in which CMS conducted validation surveys during that quarter. (f) Appeal of FFP reduction. § 488.325 Disclosure of results of surveys and activities. (a) Information which must be provided to public. (1) Statements of deficiencies and providers' comments. (2) A list of isolated deficiencies that constitute no actual harm, with the potential for minimal harm. (3) Approved plans of correction. (4) Statements that the facility did not submit an acceptable plan of correction or failed to comply with the conditions of imposed remedies. (5) Final appeal results. (6) Notice of termination of a facility. (7) Medicare and Medicaid cost reports. (8) Names of individuals with direct or indirect ownership interest in a SNF or NF, as defined in § 420.201 of this chapter. (9) Names of individuals with direct or indirect ownership interest in a SNF or NF, as defined in § 420.201 of this chapter, who have been found guilty by a court of law of a criminal offense in violation of Medicare or Medicaid law. (b) Charge to public for information. (1) Section 401.140 of this chapter, for Medicare; or (2) State procedures, for Medicaid. (c) How public can request information. (d) When information must be disclosed. (e) Procedures for responding to requests. (1) Section 401.136 of this chapter for documents maintained by CMS; and (2) State procedures for documents maintained by the State. (f) Information that must be provided to the State's long-term care ombudsman. (1) A statement of deficiencies reflecting facility noncompliance, including a separate list of isolated deficiencies that constitute no harm with the potential for minimal harm. (2) Reports of adverse actions specified at § 488.406 imposed on a facility. (3) Written response by the provider. (4) A provider's request for an appeal and the results of any appeal. (g) Information which must be provided to State by a facility with substandard quality of care. (i) Each resident in the facility with respect to which such finding was made; and (ii) The name and address of his or her attending physician. (2) Failure to disclose the information timely will result in termination of participation or imposition of alternative remedies. (h) Information the State must provide to attending physician and State board. (1) The attending physician of each resident in the facility with respect to which a finding of substandard quality of care was made; and (2) The State board responsible for licensing the facility's administrator. (i) Access to information by State Medicaid fraud control unit. [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] § 488.330 Certification of compliance or noncompliance. (a) General rules Responsibility for certification. (A) The State certifies the compliance or noncompliance of non-State operated NFs. Regardless of the State entity doing the certification, it is final, except in the case of a complaint or validation survey conducted by CMS, or CMS review of the State's findings. (B) CMS certifies the compliance or noncompliance of all State-operated facilities. (C) The State survey agency certifies the compliance or noncompliance of a non-State operated SNF, subject to the approval of CMS. (D) The State survey agency certifies compliance or noncompliance for a dually participating SNF/NF. In the case of a disagreement between CMS and the State survey agency, a finding of noncompliance takes precedence over that of compliance. (ii) In the case of a validation survey, the Secretary's determination as to the facility's noncompliance is binding, and takes precedence over a certification of compliance resulting from the State survey. (2) Basis for certification. (ii) Certification by CMS is based on either the survey agency findings (in the case of State-operated facilities), or, in the case of a validation survey, on CMS's own survey findings. (b) Effect of certification Certification of compliance. (2) Certification of noncompliance. (i) Termination of any Medicare or Medicaid provider agreements that are in effect. (ii) Application of alternative remedies instead of, or in addition to, termination procedures. (c) Notice of certification of noncompliance and resulting action. (d) Content of notice of certification of noncompliance. (1) Nature of noncompliance. (2) Any alternative remedies to be imposed under subpart F of this part. (3) Any termination or denial of participation action to be taken under this part. (4) The appeal rights available to the facility under this part. (5) Timeframes to be met by the provider and certifying agency with regard to each of the enforcement actions or appeal procedures addressed in the notice. (e) Appeals. (i) After promptly notifying the facility of the deficiencies and impending remedy or remedies; and (ii) Except for civil money penalties, during any pending hearing that may be requested by the provider of services. (2) CMS imposes remedies promptly on any provider of services participating in the Medicare or Medicaid program or any provider of services participating in both the Medicare and Medicaid programs— (i) After promptly notifying the facility of the deficiencies and impending remedy or remedies; and (ii) Except for civil money penalties imposed on NFs-only by the State, during any pending hearing that may be requested by the provider of services. (3) The provisions of part 498 of this chapter apply when the following providers request a hearing on a denial of participation, or certification of noncompliance leading to an enforcement remedy (including termination of the provider agreement), except State monitoring: (i) All State-operated facilities; (ii) SNFs and dually participating SNF/NFs; and (iii) Any other facilities subject to a CMS validation survey or CMS review of the State's findings. (4) The provisions of part 431 of this chapter apply when a non-State operated Medicaid NF, which has not received a CMS validation survey or CMS review of the State's findings, requests a hearing on the State's denial of participation, termination of provider agreement, or certification of noncompliance leading to an alternative remedy, except State monitoring. (f) Provider agreements. (g) Special rules for Federal validation surveys. (2) CMS issues the notice of actions affecting facilities for which CMS did validation surveys. (3) For non-State-operated NFs and non-State-operated dually participating facilities, any disagreement between CMS and the State regarding the timing and choice of remedies is resolved in accordance with § 488.452. (4) Either CMS or the survey agency, at CMS's option, may revisit the facility to ensure that corrections are made. [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995; 76 FR 15126, Mar. 18, 2011] § 488.331 Informal dispute resolution. (a) Opportunity to refute survey findings. (2) For Federal surveys, CMS offers a facility an informal opportunity, at the facility's request, to dispute survey findings upon the facility's receipt of the official statement of deficiencies. (3) For SNFs, dually-participating SNF/NFs, and NF-only facilities that have civil money penalties imposed by CMS that will be placed in a CMS escrow account, CMS also offers the facility an opportunity for independent informal dispute resolution, subject to the terms of paragraphs (b), (c), and (d) of this section and of § 488.431. The facility must request independent informal dispute resolution in writing within 10 days of receipt of CMS's offer. However, a facility may not use the dispute resolution processes at both §§ 488.331 and 488.431 for the same deficiency citation arising from the same survey unless the informal dispute resolution process at § 488.331 was completed prior to the imposition of the civil money penalty. (b)(1) Failure of the State or CMS, as appropriate, to complete informal dispute resolution timely cannot delay the effective date of any enforcement action against the facility. (2) A facility may not seek a delay of any enforcement action against it on the grounds that informal dispute resolution has not been completed before the effective date of the enforcement action. (c) If a provider is subsequently successful, during the informal dispute resolution process, at demonstrating that deficiencies should not have been cited, the deficiencies are removed from the statement of deficiencies and any enforcement actions imposed solely as a result of those cited deficiencies are rescinded. (d) Notification. [59 FR 56238, Nov. 10, 1994, as amended at 76 FR 15126, Mar. 18, 2011] § 488.332 Investigation of complaints of violations and monitoring of compliance. (a) Investigation of complaints. (2) The State survey agency takes appropriate precautions to protect a complainant's anonymity and privacy, if possible. (3) If arrangements have been made with other State components for investigation of complaints, the State must have a means of communicating information among appropriate entities, and the State survey agency retains responsibility for the investigation process. (4) If, after investigating a complaint, the State has reason to believe that an identifiable individual neglected or abused a resident, or misappropriated a resident's property, the State survey agency must act on the complaint in accordance with § 488.335. (b) On-site monitoring. (1) A facility is not in substantial compliance with the requirements and is in the process of correcting deficiencies; (2) A facility has corrected deficiencies and verification of continued substantial compliance is needed; or (3) The survey agency has reason to question the substantial compliance of the facility with a requirement of participation. (c) Composition of the investigative team. § 488.334 Educational programs. A State must conduct periodic educational programs for the staff and residents (and their representatives) of SNFs and NFs in order to present current regulations, procedures, and policies on the survey, certification and enforcement process under this subpart and subpart F of this part. § 488.335 Action on complaints of resident neglect and abuse, and misappropriation of resident property. (a) Investigation. (2) If there is reason to believe, either through oral or written evidence that an individual used by a facility to provide services to residents could have abused or neglected a resident or misappropriated a resident's property, the State must investigate the allegation. (3) The State must have written procedures for the timely review and investigation of allegations of resident abuse and neglect, and misappropriation of resident property. (b) Source of complaints. (c) Notification Individuals to be notified. (i) The individuals implicated in the investigation; and (ii) The current administrator of the facility in which the incident occurred. (2) Timing of the notice. (3) Contents of the notice. (i) Nature of the allegation(s); (ii) Date and time of the occurrence; (iii) Right to a hearing; (iv) Intent to report the substantiated findings in writing, once the individual has had the opportunity for a hearing, to the nurse aide registry or appropriate licensure authority; (v) Fact that the individual's failure to request a hearing in writing within 30 days from the date of the notice will result in reporting the substantiated findings to the nurse aide registry or appropriate licensure authority. (vi) Consequences of waiving the right to a hearing; (vii) Consequences of a finding through the hearing process that the alleged resident abuse or neglect, or misappropriation of resident property did occur; and (viii) Fact that the individual has the right to be represented by an attorney at the individual's own expense. (d) Conduct of hearing. (2) The State must hold the hearing at a reasonable place and time convenient for the individual. (e) Factors beyond the individual's control. (f) Report of findings. (1) The individual; (2) The current administrator of the facility in which the incident occurred; and (3) The administrator of the facility that currently employs the individual, if different than the facility in which the incident occurred; (4) The licensing authority for individuals used by the facility other than nurse aides, if applicable; and (5) The nurse aide registry for nurse aides. Only the State survey agency may report the findings to the nurse aide registry, and this must be done within 10 working days of the findings, in accordance with § 483.156(c) of this chapter. The State survey agency may not delegate this responsibility. (g) Contents and retention of report of finding to the nurse aide registry. (2) The survey agency must retain the information as specified in paragraph (g)(1) of this section, in accordance with the procedures specified in § 483.156(c) of this chapter. (h) Survey agency responsibility. (2) If a facility is not in substantial compliance with the requirements in part 483, subpart B of this chapter, the survey agency initiates appropriate actions, as specified in subpart F of this part. [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] Subpart F—Enforcement of Compliance for Long-Term Care Facilities with Deficiencies Source: 59 FR 56243, Nov. 10, 1994, unless otherwise noted. § 488.400 Statutory basis. Sections 1819(h) and 1919(h) of the Act specify remedies that may be used by the Secretary or the State respectively when a SNF or a NF is not in substantial compliance with the requirements for participation in the Medicare and Medicaid programs. These sections also provide for ensuring prompt compliance and specify that these remedies are in addition to any other available under State or Federal law, and, except, for civil money penalties imposed on NFs-only by the State, are imposed prior to the conduct of a hearing. [76 FR 15126, Mar. 18, 2011] § 488.401 Definitions. As used in this subpart— Instance or instances of noncompliance New admission Plan of correction [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 89 FR 64162, Aug. 6, 2024] § 488.402 General provisions. (a) Purpose of remedies. (b) Basis for imposition and duration of remedies. (c) Number of remedies. (d) Plan of correction requirement. (2) Isolated deficiencies. (e) Disagreement regarding remedies. (f) Notification requirements (i) Nature of the noncompliance; (ii) Which remedy is imposed; (iii) Effective date of the remedy; and (iv) Right to appeal the determination leading to the remedy. (2) When a State is taking action against a non-State operated NF, the State's notice must include the same information required by CMS in paragraph (f)(1) of this section. (3) Immediate jeopardy—2 day notice. (4) No immediate jeopardy—15 day notice. (5) Date of enforcement action. (6) Civil money penalties. (7) State monitoring. [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 64 FR 13360, Mar. 18, 1999] § 488.404 Factors to be considered in selecting remedies. (a) Initial assessment. (b) Determining seriousness of deficiencies. (1) Whether a facility's deficiencies constitute— (i) No actual harm with a potential for minimal harm; (ii) No actual harm with a potential for more than minimal harm, but not immediate jeopardy; (iii) Actual harm that is not immediate jeopardy; or (iv) Immediate jeopardy to resident health or safety. (2) Whether the deficiencies— (i) Are isolated; (ii) Constitute a pattern; or (iii) Are widespread. (c) Other factors which may be considered in choosing a remedy within a remedy category. (1) The relationship of the one deficiency to other deficiencies resulting in noncompliance. (2) The facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies. § 488.406 Available remedies. (a) General. (1) Temporary management. (2) Denial of payment including— (i) Denial of payment for all individuals, imposed by CMS, to a— (A) Skilled nursing facility, for Medicare; (B) State, for Medicaid; or (ii) Denial of payment for all new admissions. (3) Civil money penalties. (4) State monitoring. (5) Transfer of residents. (6) Closure of the facility and transfer of residents. (7) Directed plan of correction. (8) Directed in-service training. (9) Alternative or additional State remedies approved by CMS. (b) Remedies that must be established. (1) Temporary management. (2) Denial of payment for new admissions. (3) Civil money penalties. (4) Transfer of residents. (5) Closure of the facility and transfer of residents. (6) State monitoring. (c) State plan requirement. (1) Specify those remedies in the State plan; and (2) Demonstrate to CMS's satisfaction that those remedies are as effective as the remedies listed in paragraph (a) of this section, for deterring noncompliance and correcting deficiencies. (d) State remedies in dually participating facilities. [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] § 488.408 Selection of remedies. (a) Categories of remedies. (b) Application of remedies. (c) Category 1. (i) Directed plan of correction. (ii) State monitoring. (iii) Directed in-service training. (2) CMS does or the State must apply one or more of the remedies in Category 1 when there— (i) Are isolated deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy; or (ii) Is a pattern of deficiencies that constitutes no actual harm with a potential for more than minimal harm but not immediate jeopardy. (3) Except when the facility is in substantial compliance, CMS or the State may apply one or more of the remedies in Category 1 to any deficiency. (d) Category 2. (i) Denial of payment for new admissions. (ii) Denial of payment for all individuals imposed only by CMS. (iii) Civil money penalties of $50-3,000 as adjusted annually under 45 CFR part 102 per day. (iv) Civil money penalty of $1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance of noncompliance. (2) CMS applies one or more of the remedies in Category 2, or, except for denial of payment for all individuals, the State must apply one or more of the remedies in Category 2 when there are— (i) Widespread deficiencies that constitute no actual harm with a potential for more than minimal harm but not immediate jeopardy; or (ii) One or more deficiencies that constitute actual harm that is not immediate jeopardy. (3) CMS or the State may apply one or more of the remedies in Category 2 to any deficiency except when— (i) The facility is in substantial compliance; or (ii) CMS or the State imposes a civil money penalty for a deficiency that constitutes immediate jeopardy, the penalty must be in the upper range of penalty amounts, as specified in § 488.438(a). (e) Category 3. (i) Temporary management. (ii) Immediate termination. (iii) Civil money penalties of $3,050-$10,000 as adjusted annually under 45 CFR part 102 per day. (iv) Civil money penalty of $1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance of noncompliance. (2) When there are one or more deficiencies that constitute immediate jeopardy to resident health or safety— (i) CMS does and the State must do one or both of the following: (A) Impose temporary management; or (B) Terminate the provider agreement; (ii) For each instance of noncompliance, CMS and the State may impose a civil money penalty of $3,050-$10,000 (as adjusted annually under 45 CFR part 102) per day, $1,000-$10,000 (as adjusted annually under 45 CFR part 102) per instance of noncompliance, or both, in addition to imposing the remedies specified in paragraph (e)(2)(i) of this section. For multiple instances of noncompliance, CMS may impose any combination of per instance or per day civil money penalties for each instance within the same survey. The aggregate civil money penalty amount may not exceed $10,000 (as adjusted annually under 45 CFR part 102) for each day of noncompliance. (3) When there are widespread deficiencies that constitute actual harm that is not immediate jeopardy, CMS and the State may impose temporary management, in addition to Category 2 remedies. (f) Plan of correction. (i) Which remedies are imposed; or (ii) The seriousness of the deficiencies. (2) When there are only isolated deficiencies that CMS or the State determines constitute no actual harm with a potential for minimal harm, the facility need not submit a plan of correction. (g) Appeal of a certification of noncompliance. (2) A facility may not appeal the choice of remedy, including the factors considered by CMS or the State in selecting the remedy, specified in § 488.404. [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 64 FR 13360, Mar. 18, 1999; 81 FR 61563, Sept. 6, 2016; 89 FR 64162, Aug. 6, 2024] § 488.410 Action when there is immediate jeopardy. (a) If there is immediate jeopardy to resident health or safety, the State must (and CMS does) either terminate the provider agreement within 23 calendar days of the last date of the survey or appoint a temporary manager to remove the immediate jeopardy. The rules for appointment of a temporary manager in an immediate jeopardy situation are as follows: (1) CMS does and the State must notify the facility that a temporary manager is being appointed. (2) If the facility fails to relinquish control to the temporary manager, CMS does and the State must terminate the provider agreement within 23 calendar days of the last day of the survey, if the immediate jeopardy is not removed. In these cases, State monitoring may be imposed pending termination. (3) If the facility relinquishes control to the temporary manager, the State must (and CMS does) notify the facility that, unless it removes the immediate jeopardy, its provider agreement will be terminated within 23 calendar days of the last day of the survey. (4) CMS does and the State must terminate the provider agreement within 23 calendar days of the last day of survey if the immediate jeopardy has not been removed. (b) CMS or the State may also impose other remedies, as appropriate. (c)(1) In a NF or dually participating facility, if either CMS or the State finds that a facility's noncompliance poses immediate jeopardy to resident health or safety, CMS or the State must notify the other of such a finding. (2) CMS will or the State must do one or both of the following: (i) Take immediate action to remove the jeopardy and correct the noncompliance through temporary management. (ii) Terminate the facility's participation under the State plan. If this is done, CMS will also terminate the facility's participation in Medicare if it is a dually participating facility. (d) The State must provide for the safe and orderly transfer of residents when the facility is terminated. (e) If the immediate jeopardy is also substandard quality of care, the State survey agency must notify attending physicians and the State board responsible for licensing the facility administrator of the finding of substandard quality of care, as specified in § 488.325(h). [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] § 488.412 Action when there is no immediate jeopardy. (a) If a facility's deficiencies do not pose immediate jeopardy to residents' health or safety, and the facility is not in substantial compliance, CMS or the State may terminate the facility's provider agreement or may allow the facility to continue to participate for no longer than 6 months from the last day of the survey if— (1) The State survey agency finds that it is more appropriate to impose alternative remedies than to terminate the facility's provider agreement; (2) The State has submitted a plan and timetable for corrective action approved by CMS; and (3) The facility in the case of a Medicare SNF or the State in the case of a Medicaid NF agrees to repay to the Federal government payments received after the last day of the survey that first identified the deficiencies if corrective action is not taken in accordance with the approved plan of correction. (b) If a facility does not meet the criteria for continuation of payment under paragraph (a) of this section, CMS will and the State must terminate the facility's provider agreement. (c) CMS does and the State must deny payment for new admissions when a facility is not in substantial compliance 3 months after the last day of the survey. (d) CMS terminates the provider agreement for SNFs and NFs, and stops FFP to a State for a NF for which participation was continued under paragraph (a) of this section, if the facility is not in substantial compliance within 6 months of the last day of the survey. [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995] § 488.414 Action when there is repeated substandard quality of care. (a) General. (1) CMS imposes denial of payment for all new admissions, as specified in § 488.417, or denial of all payments, as specified in § 488.418; (2) The State must impose denial of payment for all new admissions, as specified in § 488.417; and (3) CMS does and the State survey agency must impose State monitoring, as specified in § 488.422, until the facility has demonstrated to the satisfaction of CMS or the State, that it is in substantial compliance with all requirements and will remain in substantial compliance with all requirements. (b) Repeated noncompliance. (c) Standard surveys to which this provision applies. (d) Program participation. (2) Termination would allow the count of repeated substandard quality of care surveys to start over. (3) Change of ownership. (i) A facility may not avoid a remedy on the basis that it underwent a change of ownership. (ii) In a facility that has undergone a change of ownership, CMS does not and the State may not restart the count of repeated substandard quality of care surveys unless the new owner can demonstrate to the satisfaction of CMS or the State that the poor past performance no longer is a factor due to the change in ownership. (e) Facility alleges corrections or achieves compliance after repeated substandard quality of care is identified. (2) A facility will not avoid the imposition of remedies or the obligation to demonstrate that it will remain in compliance when it— (i) Alleges correction of the deficiencies cited in the most recent standard survey; or (ii) Achieves compliance before the effective date of the remedies. § 488.415 Temporary management. (a) Definition. (b) Qualifications. (1) Be qualified to oversee correction of deficiencies on the basis of experience and education, as determined by the State; (2) Not have been found guilty of misconduct by any licensing board or professional society in any State; (3) Have, or a member of his or her immediate family have, no financial ownership interest in the facility; and (4) Not currently serve or, within the past 2 years, have served as a member of the staff of the facility. (c) Payment of salary. (1) Is paid directly by the facility while the temporary manager is assigned to that facility; and (2) Must be at least equivalent to the sum of the following— (i) The prevailing salary paid by providers for positions of this type in what the State considers to be the facility's geographic area; (ii) Additional costs that would have reasonably been incurred by the provider if such person had been in an employment relationship; and (iii) Any other costs incurred by such a person in furnishing services under such an arrangement or as otherwise set by the State. (3) May exceed the amount specified in paragraph (c)(2) of this section if the State is otherwise unable to attract a qualified temporary manager. (d) Failure to relinquish authority to temporary management Termination of provider agreement. (2) Failure to pay salary of temporary manager. (e) Duration of temporary management. § 488.417 Denial of payment for all new admissions. (a) Optional denial of payment. (1) Medicare facilities. (2) Medicaid facilities. (i) The State may deny payment to the facility; and (ii) CMS may deny payment to the State for all new Medicaid admissions to the facility. (b) Required denial of payment. (1) The facility is not in substantial compliance, as defined in § 488.401, 3 months after the last day of the survey identifying the noncompliance; or (2) The State survey agency has cited a facility with substandard quality of care on the last three consecutive standard surveys. (c) Resumption of payments: Repeated instances of substandard quality of care. (1) The facility achieves substantial compliance as indicated by a revisit or written credible evidence acceptable to CMS (for all facilities except non-State operated NFs against which CMS is imposing no remedies) or the State (for non-State operated NFs against which CMS is imposing no remedies); and (2) CMS (for all facilities except non-State operated NFs against which CMS is imposing no remedies) or the State (for non-State operated NFs against which CMS is imposing no remedies) believes that the facility is capable of remaining in substantial compliance. (d) Resumption of payments: No repeated instances of substandard quality of care. (e) Restriction. (1) Denial of payment remedy is imposed; and (2) Facility achieves substantial compliance, as determined by CMS or the State. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995] § 488.418 Secretarial authority to deny all payments. (a) CMS option to deny all payment. (b) Prospective resumption of payment. (c) Restriction on payment after denial of payment is imposed. (1) Denial of payment was imposed; and (2) CMS verifies as the date that the facility achieved substantial compliance. (d) Retroactive resumption of payment. (e) Resumption of payment—repeated instances of substandard care. (1) The facility achieved substantial compliance, as indicated by a revisit or written credible evidence acceptable to CMS; and (2) CMS believes that the facility will remain in substantial compliance. § 488.422 State monitoring. (a) A State monitor— (1) Oversees the correction of deficiencies specified by CMS or the State survey agency at the facility site and protects the facility's residents from harm; (2) Is an employee or a contractor of the survey agency; (3) Is identified by the State as an appropriate professional to monitor cited deficiencies; (4) Is not an employee of the facility; (5) Does not function as a consultant to the facility; and (6) Does not have an immediate family member who is a resident of the facility to be monitored. (b) A State monitor must be used when a survey agency has cited a facility with substandard quality of care deficiencies on the last 3 consecutive standard surveys. (c) State monitoring is discontinued when— (1) The facility has demonstrated that it is in substantial compliance with the requirements, and, if imposed for repeated instances of substandard quality of care, will remain in compliance for a period of time specified by CMS or the State; or (2) Termination procedures are completed. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995] § 488.424 Directed plan of correction. CMS, the State survey agency, or the temporary manager (with CMS or State approval) may develop a plan of correction and CMS, the State, or the temporary manager require a facility to take action within specified timeframes. § 488.425 Directed inservice training. (a) Required training. (1) The facility has a pattern of deficiencies that indicate noncompliance; and (2) Education is likely to correct the deficiencies. (b) Action following training. (c) Payment. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995] § 488.426 Transfer of residents, or closure of the facility and transfer of residents. (a) Transfer of residents, or closure of the facility and transfer of residents in an emergency. (1) Transfer Medicaid and Medicare residents to another facility; or (2) Close the facility and transfer the Medicaid and Medicare residents to another facility. (b) Required transfer when a facility's provider agreement is terminated. (c) Required notifications when a facility's provider agreement is terminated. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 76 FR 9511, Feb. 18, 2011; 81 FR 68872, Oct. 4, 2016] § 488.430 Civil money penalties: Basis for imposing penalty. (a) CMS or the State may impose a civil money penalty for the number of days a facility is not in substantial compliance with one or more participation requirements or for each instance that a facility is not in substantial compliance, or both, regardless of whether or not the deficiencies constitute immediate jeopardy. When a survey contains multiple instances of noncompliance, CMS or the State may impose any combination of per instance or per day civil money penalties for each instance of noncompliance within the same survey. (b) CMS or the State may impose a civil money penalty for the number of days or instances of previously cited noncompliance, including the number of days of immediate jeopardy, since the last three standard surveys. [89 FR 64163, Aug. 6, 2024] § 488.431 Civil money penalties imposed by CMS and independent informal dispute resolution: for SNFS, dually-participating SNF/NFs, and NF-only facilities. (a) Opportunity for independent review. (1) Be completed within 60 days of facility's request if an independent informal dispute resolution is timely requested by the facility. (2) Generate a written record prior to the collection of the penalty. (3) Include notification to an involved resident or resident representative, as well as the State's long term care ombudsman, to provide opportunity for written comment. (4) Be approved by CMS and conducted by the State under section 1864 of the Act, or by an entity approved by the State and CMS, or by CMS or its agent in the case of surveys conducted only by federal surveyors where the State independent dispute resolution process is not used, and which has no conflict of interest, such as: (i) A component of an umbrella State agency provided that the component is organizationally separate from the State survey agency. (ii) An independent entity with a specific understanding of Medicare and Medicaid program requirements selected by the State and approved by CMS. (5) Not include the survey findings that have already been the subject of an informal dispute resolution under § 488.331 for the particular deficiency citations at issue in the independent process under § 488.431, unless the informal dispute resolution under § 488.331 was completed prior to the imposition of the civil money penalty. (b) Collection and placement in escrow account. (i) The date on which the independent informal dispute resolution process is completed under paragraph (a) of this section. (ii) The date that is 90 days after the date of the notice of imposition of the penalty. (2) For collection and placement in escrow accounts of per day civil money penalties, CMS may collect the portion of the per day civil money penalty that has accrued up to the time of collection as specified in paragraph (b)(1) of this section. CMS may make additional collections periodically until the full amount is collected, except that the full balance must be collected once the facility achieves substantial compliance or is terminated from the program and CMS determines the final amount of the civil money penalty imposed. (3) CMS may provide for an escrow payment schedule that differs from the collection times of paragraph (1) of this subsection in any case in which CMS determines that more time is necessary for deposit of the total civil money penalty into an escrow account, not to exceed 12 months, if CMS finds that immediate payment would create substantial and undue financial hardship on the facility. (4) If the full civil money penalty is not placed in an escrow account within 30 calendar days from the date the provider receives notice of collection, or within 30 calendar days of any due date established pursuant to a hardship finding under paragraph (b)(3), CMS may deduct the amount of the civil money penalty from any sum then or later owed by CMS or the State to the facility in accordance with § 488.442(c). (5) For any civil money penalties that are not collected and placed into an escrow account under this section, CMS will collect such civil money penalties in the same manner as the State in accordance with § 488.432. (c) Maintenance of escrowed funds. (d) When a facility requests a hearing. (2) If the administrative law judge reverses deficiency findings that comprise the basis of a civil money penalty in whole or in part, the escrowed amounts continue to be held pending expiration of the time for CMS to appeal the decision or, where CMS does appeal, a Departmental Appeals Board decision affirming the reversal of the pertinent deficiency findings. Any collected civil money penalty amount owed to the facility based on a final administrative decision will be returned to the facility with applicable interest as specified in section 1878(f)(2) of the Act. [76 FR 15126, Mar. 18, 2011] § 488.432 Civil money penalties imposed by the State: NF-only. (a) When a facility requests a hearing. (2)(i) If a facility requests a hearing within the time frame specified in paragraph (a)(1) of this section, for a civil money penalty imposed per day, the State initiates collection of the penalty when there is a final administrative decision that upholds the State's determination of noncompliance after the facility achieves substantial compliance or is terminated. (ii) If a facility requests a hearing for a civil money penalty imposed per instance of noncompliance within the time specified in paragraph (a)(1) of this section, the State initiates collection of the penalty when there is a final administrative decision that upholds the State's determination of noncompliance. (b) When a facility does not request a hearing for a civil money penalty imposed per day. (i) Achieves substantial compliance; or (ii) Is terminated. (2) When a facility does not request a hearing for a civil money penalty imposed per instance of noncompliance. (c) When a facility waives a hearing. (2) If a facility waives its right to a hearing as specified in § 488.436, the State initiates collection of civil money penalty imposed per instance of noncompliance after 60 days from the date of the notice imposing the penalty and the State has not received a timely request for a hearing. (d) Accrual and computation of penalties for a facility that— (1) Requests a hearing or does not request a hearing are specified in § 488.440; (2) Waives its right to a hearing in writing, are specified in §§ 488.436(b) and 488.440. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 64 FR 13360, Mar. 18, 1999; 76 FR 15127, Mar. 18, 2011; 88 FR 53347, Aug. 7, 2023] § 488.433 Civil money penalties: Uses and approval of civil money penalties imposed by CMS. (a) Ten percent of the collected civil money penalty funds that are required to be held in escrow pursuant to § 488.431 and that remain after a final administrative decision will be deposited with the Department of the Treasury in accordance with § 488.442(f). The remaining ninety percent of the collected civil money penalty funds that are required to be held in escrow pursuant to § 488.431 and that remain after a final administrative decision must be used entirely for activities that protect or improve the quality of care or quality of life for residents consistent with paragraph (b) of this section and may not be used for survey and certification operations or State expenses, except that reasonable expenses necessary to administer, monitor, or evaluate the effectiveness of projects utilizing civil money penalty funds may be permitted. (b) All activities and plans for utilizing civil money penalty funds, including any expense used to administer grants utilizing civil money penalty funds, must be approved in advance by CMS and may include, but are not limited to: (1) Support and protection of residents of a facility that closes (voluntarily or involuntarily). (2) Time-limited expenses incurred in the process of relocating residents to home and community-based settings or another facility when a facility is closed (voluntarily or involuntarily) or downsized pursuant to an agreement with the State Medicaid agency. (3) Projects that support resident and family councils and other consumer involvement in assuring quality care in facilities. (4) Facility improvement initiatives, such as joint training of facility staff and surveyors or technical assistance for facilities implementing quality assurance and performance improvement programs. (5) Development and maintenance of temporary management or receivership capability such as but not limited to, recruitment, training, retention or other system infrastructure expenses. However, as specified in § 488.415(c), a temporary manager's salary must be paid by the facility. In rare situations, if the facility is closing, CMS plans to stop or suspend continued payments to the facility under § 489.55 of this chapter during the temporary manager's duty period, and CMS determines that extraordinary action is necessary to protect the residents until relocation efforts are successful, civil money penalty funds may be used to pay the manager's salary. (c) At a minimum, proposed activities submitted to CMS for prior approval must include a description of the intended outcomes, deliverables, and sustainability; and a description of the methods by which the activity results will be assessed, including specific measures. (d) Civil money penalty funds may not be used for activities that have been disapproved by CMS. (e) The State must maintain an acceptable plan, approved by CMS, for the effective use of civil money funds, including a description of methods by which the State will: (1) Solicit, accept, monitor, and track projects utilizing civil money penalty funds including any funds used for state administration. (2) Make information about the use of civil money penalty funds publicly available, including about the dollar amount awarded for approved projects, the grantee or contract recipients, the results of projects, and other key information. (3) Ensure that: (i) A core amount of civil money penalty funds will be held in reserve for emergencies, such as relocation of residents pursuant to an involuntary termination from Medicare and Medicaid. (ii) A reasonable amount of funds, beyond those held in reserve under paragraph (e)(3)(i) of this section, will be awarded or contracted each year for the purposes specified in this section. (f) If CMS finds that a State has not spent civil money penalty funds in accordance with this section, or fails to make use of funds to benefit the quality of care or life of residents, or fails to maintain an acceptable plan for the use of funds that is approved by CMS, then CMS may withhold future disbursements of civil money penalty funds to the State until the State has submitted an acceptable plan to comply with this section. [79 FR 45658, Aug. 5, 2014] § 488.434 Civil money penalties: Notice of penalty. (a) CMS notice of penalty. (2) Content of notice. (i) The nature of the noncompliance; (ii) The statutory basis for the penalty; (iii) Either the amount of penalty per day of noncompliance or the amount of the penalty per instance of noncompliance or both; (iv) Any factors specified in § 488.438(f) that were considered when determining the amount of the penalty; (v) The date(s) of the instance(s) of noncompliance or the date on which the penalty begins to accrue; (vi) When the penalty stops accruing, if applicable; (vii) When the penalty is collected; and (viii) Instructions for responding to the notice, including a statement of the facility's right to a hearing, and the implication of waiving a hearing, as provided in § 488.436. (b) State notice of penalty. (2) The State's notice must— (i) Be in writing; and (ii) Include, at a minimum, the information specified in paragraph (a)(2) of this section. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 64 FR 13360, Mar. 18, 1999; 89 FR 64163, Aug. 6, 2024] § 488.436 Civil money penalties: Waiver of hearing, reduction of penalty amount. (a) Constructive waiver of a hearing. (b) Reduction of penalty amount. (2) If the facility does not waive its right to a hearing in accordance with the procedures specified in paragraph (a) of this section, the civil money penalty is not reduced by 35 percent. [59 FR 56243, Nov. 10, 1994; 62 FR 44221, Aug. 20, 1997, as amended at 76 FR 15127, Mar. 18, 2011; 88 FR 53347, Aug. 7, 2023] § 488.438 Civil money penalties: Amount of penalty. (a) Amount of penalty. (i) Upper range. (ii) Upper range. (2) Per instance penalty. (b) Basis for penalty amount. (c) Decreased penalty amounts. (2) When CMS determines that a SNF, dually-participating SNF/NF, or NF-only facility subject to a civil money penalty imposed by CMS self-reports and promptly corrects the noncompliance for which the civil money penalty was imposed, CMS will reduce the amount of the penalty by 50 percent, provided that all of the following apply — (i) The facility self-reported the noncompliance to CMS or the State before it was identified by CMS or the State and before it was reported to CMS or the State by means of a complaint lodged by a person other than an official representative of the nursing home; (ii) Correction of the self-reported noncompliance occurred on whichever of the following occurs first: (A) 15 calendar days from the date of the circumstance or incident that later resulted in a finding of noncompliance; or (B) 10 calendar days from the date the civil money penalty was imposed; (iii) The facility waives its right to a hearing under § 488.436; (iv) The noncompliance that was self-reported and corrected did not constitute a pattern of harm, widespread harm, immediate jeopardy, or result in the death of a resident; (v) The civil money penalty was not imposed for a repeated deficiency, as defined in paragraph (d)(3) of this section, that was the basis of a civil money penalty that previously received a reduction under this section; and (vi) The facility has met mandatory reporting requirements for the incident or circumstance upon which the civil money penalty is based, as required by Federal and State law. (3) Under no circumstances will a facility receive both the 50 percent civil money penalty reduction for self-reporting and correcting under this section and the 35 percent civil money penalty reduction for waiving its right to a hearing under § 488.436. (d) Increased penalty amounts. (2) CMS does and the State must increase the per day penalty amount for any repeated deficiencies for which a lower level penalty amount was previously imposed, regardless of whether the increased penalty amount would exceed the range otherwise reserved for nonimmediate jeopardy deficiencies. (3) Repeated deficiencies are deficiencies in the same regulatory grouping of requirements found at the last survey, subsequently corrected, and found again at the next survey. (e) Review of the penalty. (1) Set a penalty of zero or reduce a penalty to zero; (2) Review the exercise of discretion by CMS or the State to impose a civil money penalty; and (3) Consider any factors in reviewing the amount of the penalty other than those specified in paragraph (f) of this section. (f) Factors affecting the amount of penalty. (1) The facility's history of noncompliance, including repeated deficiencies. (2) The facility's financial condition. (3) The factors specified in § 488.404. (4) The facility's degree of culpability. Culpability [59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13360, Mar. 18, 1999; 68 FR 46072, Aug. 4, 2003; 76 FR 15127, Mar. 18, 2011; 81 FR 61563, Sept. 6, 2016] § 488.440 Civil money penalties: Effective date and duration of penalty. (a)(1) The per day civil money penalty may start accruing as early as the date that the facility was first out of compliance, as determined by CMS or the State. (2) A civil money penalty for each instance of noncompliance is imposed in a specific amount per instance. (b) The per day civil money penalty is computed and collectible, as specified in §§ 488.431, 488.432, and 488.442 for the number of days of noncompliance until the date the facility achieves substantial compliance, or, if applicable, the date of termination when — (1) The determination of noncompliance is upheld after a final administrative decision for NFs-only subject to civil money penalties imposed by the state or for civil money penalties imposed by CMS that are not collected and placed into an escrow account; (2) The facility waives its right to a hearing in accordance with § 488.436; or (3) The time for requesting a hearing has expired and CMS or the State has not received a hearing request from the facility. (c)(1) For NFs-only subject to civil money penalties imposed by the State and for civil money penalties imposed by CMS that may not be placed in an escrow account, the entire penalty, whether imposed on a per day or per instance basis, is due and collectible as specified in the notice sent to the provider under paragraphs (d) and (e) of this section. (2) For SNFs, dually-participating SNF/NFs, or NFs subject to civil money penalties imposed by CMS, collection is made in accordance with § 488.431. (d)(1) When a civil money penalty is imposed on a per day basis and the facility achieves substantial compliance, CMS does or the State must send a separate notice to the facility containing the following information: (i) The amount of penalty per day. (ii) The number of days involved. (iii) The total amount due. (iv) The due date of the penalty. (v) The rate of interest assessed on the unpaid balance beginning on the due date, as provided in § 488.442. (2) When a civil money penalty is imposed for an instance of noncompliance, CMS does or the State must send a separate notice to the facility containing the following information: (i) The amount of the penalty. (ii) The total amount due. (iii) The due date of the penalty. (iv) The rate of interest assessed on the unpaid balance beginning on the due date, as provided in § 488.442. (e) In the case of a facility for which the provider agreement has been terminated and on which a civil money penalty was imposed on a per day basis, CMS does or the State must send this penalty information after the— (1) Final administrative decision is made; (2) Facility has waived its right to a hearing in accordance with § 488.436; or (3) Time for requesting a hearing has expired and CMS or the state has not received a hearing request from the facility. (f) Accrual of penalties when there is no immediate jeopardy. (2) After the period specified in paragraph (f)(1) of this section, if the facility has not achieved substantial compliance, CMS terminates the provider agreement and the State may terminate the provider agreement. (g)(1) In a case when per day civil money penalties are imposed, when a facility has deficiencies that pose immediate jeopardy, CMS does or the State must terminate the provider agreement within 23 calendar days after the last day of the survey if the immediate jeopardy remains. (2) The accrual of the civil money penalty imposed on a per day basis stops on the day the provider agreement is terminated. (h)(1) If an on-site revisit is necessary to confirm substantial compliance and the provider can supply documentation acceptable to CMS or the State agency that substantial compliance was achieved on a date preceding the revisit, penalties imposed on a per day basis only accrue until that date of correction for which there is written credible evidence. (2) If an on-site revisit is not necessary to confirm substantial compliance, penalties imposed on a per day basis only accrue until the date of correction for which CMS or the State receives and accepts written credible evidence. [59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13361, Mar. 18, 1999; 76 FR 15128, Mar. 18, 2011; 89 FR 64163, Aug. 6, 2024] § 488.442 Civil money penalties: Due date for payment of penalty. (a) When payments are due for a civil money penalty. (2) After the facility waives its right to a hearing in accordance with § 488.436(a). (i) The facility achieved substantial compliance before the hearing request was due; or (ii) The effective date of termination occurs before the hearing request was due. (3) After the effective date of termination. (b) [Reserved] (c) Deduction of penalty from amount owed. (d) Interest Assessment. (2) Medicare interest. (i) The rate fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date of the notice of the penalty amount due (published quarterly in the Federal Register (ii) The current value of funds (published annually in the Federal Register (3) Medicaid interest. (e) Penalties collected by CMS. (1) Medicare-participating facilities are deposited and disbursed in accordance with § 488.433; and (2) Medicaid-participating facilities are returned to the State. (f) Collection from dually participating facilities. (g) Penalties collected by the State. (1) Payment for the cost of relocating residents to other facilities; (2) State costs related to the operation of a facility pending correction of deficiencies or closure; and (3) Reimbursement of residents for personal funds or property lost at a facility as a result of actions by the facility or by individuals used by the facility to provide services to residents. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 64 FR 13361, Mar. 18, 1999; 76 FR 15128, Mar. 18, 2011; 88 FR 53347, Aug. 7, 2023] § 488.444 Civil money penalties: Settlement of penalties. (a) CMS has authority to settle cases at any time prior to a final administrative decision for Medicare-only SNFs, State-operated facilities, or other facilities for which CMS's enforcement action prevails, in accordance with § 488.330. (b) The State has the authority to settle cases at any time prior to the evidentiary hearing decision for all cases in which the State's enforcement action prevails. § 488.446 Administrator sanctions: long-term care facility closures. Any individual who is or was the administrator of a facility and fails or failed to comply with the requirements at § 483.70(l) of this chapter— (a) Will be subject to a civil monetary penalty as follows: (1) A minimum of $500 as adjusted annually under 45 CFR part 102 for the first offense. (2) A minimum of $1,500 as adjusted annually under 45 CFR part 102 for the second offense. (3) A minimum of $3,000 as adjusted annually under 45 CFR part 102 for the third and subsequent offenses. (b) May be subject to exclusion from participation in any Federal health care program (as defined in section 1128B(f) of the Act); and (c) Will be subject to any other penalties that may be prescribed by law. [76 FR 9511, Feb. 18, 2011, as amended at 81 FR 61563, Sept. 6, 2016; 81 FR 68872, Oct. 4, 2016] § 488.447 Civil Money Penalties imposed for failure to comply with 42 CFR 483.80(g)(1) and (2). (a) CMS may impose a civil money penalty for noncompliance with the requirements at § 483.80(g)(1) and (2) of this chapter as follows: (1) Minimum. (2) Increased amount. (b) The penalty amounts in this section will be adjusted annually under 45 CFR part 102. (c) Compliance with the requirements at § 483.80(g)(1) and (2) of this chapter will be assessed weekly. Facilities found out of compliance with § 483.80(g)(1) and (2) of this chapter are not required to submit a plan of correction as indicated in § 488.408(f)(1). (d) This section is in effect during and the Public Health Emergency (PHE), as defined in § 400.200 of this chapter, and will continue for up to one year after the end of the PHE. [85 FR 54873, Sept. 2, 2020] § 488.450 Continuation of payments to a facility with deficiencies. (a) Criteria. (i) The State survey agency finds that it is more appropriate to impose alternative remedies than to terminate the facility; (ii) The State has submitted a plan and timetable for corrective action approved by CMS; and (iii) The facility, in the case of a Medicare SNF, or the State, in the case of a Medicaid NF, agrees to repay the Federal government payments received under this provision if corrective action is not taken in accordance with the approved plan and timetable for corrective action. (2) CMS or the State may terminate the SNF or NF agreement before the end of the correction period if the criteria in paragraph (a)(1) of this section are not met. (b) Cessation of payments. (c) Period of continued payments Non-compliance. (2) Facility closure. (d) Failure to achieve substantial compliance. (1) CMS will— (i) Terminate the provider agreement of the Medicare SNF in accordance with § 488.456; or (ii) Discontinue Federal funding to the SNF for Medicare; and (iii) Discontinue FFP to the State for the Medicaid NF. (2) The State may terminate the provider agreement for the NF. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar. 19, 2013] § 488.452 State and Federal disagreements involving findings not in agreement in non-State operated NFs and dually participating facilities when there is no immediate jeopardy. The following rules apply when CMS and the State disagree over findings of noncompliance or application of remedies in a non-State operated NF or dually participating facility: (a) Disagreement over whether facility has met requirements. (i) CMS finds that a NF or a dually participating facility is in substantial compliance with the participation requirements; and (ii) The State finds that a NF or dually participating facility has not achieved substantial compliance. (2) CMS's findings of noncompliance take precedence when— (i) CMS finds that a NF or a dually participating facility has not achieved substantial compliance; and (ii) The State finds that a NF or a dually participating facility is in substantial compliance with the participation requirements. (3) When CMS's survey findings take precedence, CMS may— (i) Impose any of the alternative remedies specified in § 488.406; (ii) Terminate the provider agreement subject to the applicable conditions of § 488.450; and (iii) Stop FFP to the State for a NF. (b) Disagreement over decision to terminate. (i) Both CMS and the State find that the facility has not achieved substantial compliance; and (ii) CMS, but not the State, finds that the facility's participation should be terminated. CMS will permit continuation of payment during the period prior to the effective date of termination not to exceed 6 months, if the applicable conditions of § 488.450 are met. (2) The State's decision to terminate a facility's participation and the procedures for appealing such termination, as specified in § 431.153(c) of this chapter, takes precedence when— (i) The State, but not CMS, finds that a NF's participation should be terminated; and (ii) The State's effective date for the termination of the NF's provider agreement is no later than 6 months after the last day of survey. (c) Disagreement over timing of termination of facility. (1) A facility is not in substantial compliance; and (2) The facility's participation should be terminated. (d) Disagreement over remedies. (i) Both CMS and the State find that a facility has not achieved substantial compliance; and (ii) Both CMS and the State find that no immediate jeopardy exists. (2) Overlap of remedies. (e) Regardless of whether CMS's or the State's decision controls, only one noncompliance and enforcement decision is applied to the Medicaid agreement, and for a dually participating facility, that same decision will apply to the Medicare agreement. § 488.454 Duration of remedies. (a) Except as specified in paragraphs (b) and (d) of this section, alternative remedies continue until— (1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit; or (2) CMS or the State terminates the provider agreement. (b) In the cases of State monitoring and denial of payment imposed for repeated substandard quality of care, remedies continue until— (1) CMS or the State determines that the facility has achieved substantial compliance and is capable of remaining in substantial compliance; or (2) CMS or the State terminates the provider agreement. (c) In the case of temporary management, the remedy continues until— (1) CMS or the State determines that the facility has achieved substantial compliance and is capable of remaining in substantial compliance; (2) CMS or the State terminates the provider agreement; or (3) The facility which has not achieved substantial compliance reassumes management control. In this case, CMS or the State initiates termination of the provider agreement and may impose additional remedies. (d) In the case of a civil money penalty imposed for an instance of noncompliance, the remedy is the specific amount of the civil money penalty imposed for the particular deficiency. (e) If the facility can supply documentation acceptable to CMS or the State survey agency that it was in substantial compliance and was capable of remaining in substantial compliance, if necessary, on a date preceding that of the revisit, the remedies terminate on the date that CMS or the State can verify as the date that substantial compliance was achieved and the facility demonstrated that it could maintain substantial compliance, if necessary. [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 64 FR 13361, Mar. 18, 1999] § 488.456 Termination of provider agreement. (a) Effect of termination. (1) Payment to the facility; and (2) Any alternative remedy. (b) Basis for termination. (i) Is not in substantial compliance with the requirements of participation, regardless of whether or not immediate jeopardy is present; or (ii) Fails to submit an acceptable plan of correction within the timeframe specified by CMS or the State. (2) CMS and the State terminate a facility's provider agreement if a facility— (i) Fails to relinquish control to the temporary manager, if that remedy is imposed by CMS or the State; or (ii) Does not meet the eligibility criteria for continuation of payment as set forth in § 488.412(a)(1). (c) Notice of termination. (1) At least 2 calendar days before the effective date of termination for a facility with immediate jeopardy deficiencies; and (2) At least 15 calendar days before the effective date of termination for a facility with non-immediate jeopardy deficiencies that constitute noncompliance. (d) Procedures for termination. (2) The State must terminate the provider agreement of a NF in accordance with procedures specified in parts 431 and 442 of this chapter. Subpart G [Reserved] Subpart H—Termination of Medicare Coverage and Alternative Sanctions for End-Stage Renal Disease (ESRD) Facilities Source: 73 FR 20475, Apr. 15, 2008, unless otherwise noted. § 488.604 Termination of Medicare coverage. (a) Except as otherwise provided in this subpart, failure of a supplier of ESRD services to meet one or more of the conditions for coverage set forth in part 494 of this chapter will result in termination of Medicare coverage of the services furnished by the supplier. (b) If termination of coverage is based solely on a supplier's failure to participate in network activities and pursue network goals, as required at § 494.180(i) of this chapter, coverage may be reinstated when CMS determines that the supplier is making reasonable and appropriate efforts to meet that condition. (c) If termination of coverage is based on failure to meet any of the other conditions specified in part 494 of this chapter, coverage will not be reinstated until CMS finds that the reason for termination has been removed and there is reasonable assurance that it will not recur. § 488.606 Alternative sanctions. (a) Basis for application of alternative sanctions. (1) The supplier fails to participate in the activities and pursue the goals of the ESRD network that is designated to encompass the supplier's geographic area; and (2) This failure does not jeopardize patient health and safety. (b) Alternative sanctions. (1) Denial of payment for services furnished to patients first accepted for care after the effective date of the sanction as specified in the sanction notice. (2) Reduction of payments, for all ESRD services furnished by the supplier, by 20 percent for each 30-day period after the effective date of the sanction. (3) Withholding of all payments, without interest, for all ESRD services furnished by the supplier to Medicare beneficiaries. (c) Duration of alternative sanction. § 488.608 Notice of alternative sanction and appeal rights: Termination of coverage. (a) Notice of alternative sanction. (b) Appeal rights. § 488.610 Notice of appeal rights: Alternative sanctions. If CMS proposes to apply an alternative sanction specified in § 488.606(b), the following rules apply: (a) CMS gives the facility notice of the proposed alternative sanction and 15 days in which to request a hearing. (b) If the facility requests a hearing, CMS provides an informal hearing by a CMS official who was not involved in making the appealed decision. (c) During the informal hearing, the facility— (1) May be represented by counsel; (2) Has access to the information on which the allegation was based; and (3) May present, orally or in writing, evidence and documentation to refute the finding of failure to participate in network activities and pursue network goals. (d) If the written decision of the informal hearing supports application of the alternative sanction, CMS provides the facility and the public, at least 30 days before the effective date of the alternative sanction, a written notice that specifies the effective date and the reasons for the alternative sanction. Subpart I—Survey and Certification of Home Health Agencies Source: 77 FR 67164, Nov. 8, 2012, unless otherwise noted. § 488.700 Basis and scope. Section 1891 of the Act establishes requirements for surveying HHAs to determine whether they meet the Medicare conditions of participation. § 488.705 Definitions. As used in this subpart— Abbreviated standard survey Complaint survey Condition-level deficiency Deficiency Extended survey Noncompliance Partial extended survey Standard-level deficiency Standard survey Substandard care Substantial compliance § 488.710 Standard surveys. (a) For each HHA, the survey agency must conduct a standard survey not later than 36 months after the date of the previous standard survey that includes, but is not limited to, all of the following (to the extent practicable): (1) A case-mix stratified sample of individuals furnished items or services by the HHA. (2) Visits to the homes of patients, (the purpose of the home visit is to evaluate the extent to which the quality and scope of services furnished by the HHA attained and maintained the highest practicable functional capacity of each patient as reflected in the patient's written plan of care and clinical records), but only with their consent, and, if determined necessary by CMS or the survey team, other forms of communication with patients including telephone calls. (3) Review of indicators that include the outcomes of quality care and services furnished by the agency as indicated by medical, nursing, and rehabilitative care. (4) Review of compliance with a select number of regulations most related to high-quality patient care. (b) The survey agency's failure to follow the procedures set forth in this section will not invalidate otherwise legitimate determinations that deficiencies exist at an HHA. § 488.715 Partial extended surveys. A partial extended survey is conducted to determine if standard or condition-level deficiencies are present in the conditions of participation not fully examined during the standard survey and there are indications that a more comprehensive review of conditions of participation would determine if a deficient practice exists. § 488.720 Extended surveys. (a) Purpose of survey. (1) To review and identify the policies and procedures that caused an HHA to furnish substandard care. (2) To determine whether the HHA is in compliance with one or more or all additional conditions of participation not examined during the standard survey. (b) Timing and basis for survey. § 488.725 Unannounced surveys. (a) Basic rule. (b) State survey agency's scheduling and surveying procedures. (c) Civil money penalties. [77 FR 67164, Nov. 8, 2012, as amended at 81 FR 61563, Sept. 6, 2016] § 488.730 Survey frequency and content. (a) Basic period. (1) Assure the delivery of quality home health services by determining whether an HHA complies with the Act and conditions of participation; and (2) Confirm that the HHA has corrected deficiencies that were previously cited. (b) Change in HHA information. (1) Ownership; (2) Administration; or, (3) Management of the HHA. (c) Complaints. (1) Must be conducted of an HHA within 2 months of when a significant number of complaints against the HHA are reported to CMS, the State, the State or local agency responsible for maintaining a toll-free hotline and investigative unit, or any other appropriate Federal, State, or local agency; or (2) As otherwise required to determine compliance with the conditions of participation such as the investigation of a complaint. § 488.735 Surveyor qualifications. (a) Minimum qualifications. (b) Disqualifications. (1) The surveyor currently works for, or, within the past two years, has worked with the HHA to be surveyed as: (i) A direct employee; (ii) An employment agency staff at the agency; or (iii) An officer, consultant, or agent for the agency to be surveyed concerning compliance with conditions of participation specified in or pursuant to sections 1861(o) or 1891(a) of the Act. (2) The surveyor has a financial interest or an ownership interest in the HHA to be surveyed. (3) The surveyor has a family member who has a relationship with the HHA to be surveyed. (4) The surveyor has an immediate family member who is a patient of the HHA to be surveyed. § 488.740 Certification of compliance or noncompliance. Rules to be followed for certification, documentation of findings, periodic review of compliance and approval, certification of noncompliance, and determining compliance of HHAs are set forth, respectively, in §§ 488.12, 488.18, 488.20, 488.24, and 488.26 of this part. § 488.745 Informal Dispute Resolution (IDR). (a) Opportunity to refute survey findings. (b) Failure to conduct IDR timely. (c) Revised statement of deficiencies as a result of IDR. (d) Notification. Subpart J—Alternative Sanctions for Home Health Agencies With Deficiencies Source: 77 FR 67165, Nov. 8, 2012, unless otherwise noted. § 488.800 Statutory basis. Section 1891(e) through (f) of the Act authorizes the Secretary to take actions to remove and correct deficiencies in an HHA through an alternative sanction or termination or both. Furthermore, this section specifies that these sanctions are in addition to any others available under State or Federal law, and, except for the final determination of civil money penalties, are imposed prior to the conduct of a hearing. § 488.805 Definitions. As used in this subpart— Directed plan of correction Immediate jeopardy New admission Per instance Plan of correction Repeat deficiency Temporary management [77 FR 67165, Nov. 8, 2012, as amended at 82 FR 4591, Jan. 13, 2017] § 488.810 General provisions. (a) Purpose of sanctions. (b) Basis for imposition of sanctions. (c) Number of sanctions. (d) Extent of sanctions imposed. (e) Plan of correction requirement. (f) Notification requirements Notice. (2) Date of enforcement action. (g) Appeals. (2) A pending hearing does not delay the effective date of a sanction, including termination, against an HHA. Sanctions continue to be in effect regardless of the timing of any appeals proceedings. § 488.815 Factors to be considered in selecting sanctions. CMS bases its choice of sanction or sanctions on consideration of one or more factors that include, but are not limited to, the following: (a) The extent to which the deficiencies pose immediate jeopardy to patient health and safety. (b) The nature, incidence, manner, degree, and duration of the deficiencies or noncompliance. (c) The presence of repeat deficiencies, the HHA's overall compliance history and any history of repeat deficiencies at either the parent or branch location. (d) The extent to which the deficiencies are directly related to a failure to provide quality patient care. (e) The extent to which the HHA is part of a larger organization with performance problems. (f) An indication of any system-wide failure to provide quality care. § 488.820 Available sanctions. In addition to termination of the provider agreement, the following alternative sanctions are available: (a) Civil money penalties. (b) Suspension of payment for all new admissions. (c) Temporary management of the HHA. (d) Directed plan of correction, as set out at § 488.850. (e) Directed in-service training, as set out at § 488.855. § 488.825 Action when deficiencies pose immediate jeopardy. (a) Immediate jeopardy. (1) CMS immediately terminates the HHA provider agreement in accordance with § 489.53 of this chapter. (2) CMS terminates the HHA provider agreement no later than 23 days from the last day of the survey, if the immediate jeopardy has not been removed by the HHA. (3) In addition to a termination, CMS may impose one or more alternative sanctions, as appropriate. (b) 2-day notice. (c) Transfer of care. § 488.830 Action when deficiencies are at the condition-level but do not pose immediate jeopardy. (a) Noncompliance. (1) Terminate the HHA's provider agreement; or (2) Impose one or more alternative sanctions set forth in § 488.820(a) through (f) of this part as an alternative to termination, for a period not to exceed 6 months. (b) 15-day notice. (c) Not meeting criteria for continuation of payment. (d) Termination time frame when there is no immediate jeopardy. (e) Transfer of care. § 488.835 Temporary management. (a) Application. (2) [Reserved] (b) Procedures. (2) If the HHA fails to relinquish authority and control to the temporary manager, CMS terminates the HHA's provider agreement in accordance with § 488.865. (c) Duration and effect of sanction. (1) CMS determines that the HHA has achieved substantial compliance and has the management capability to ensure continued compliance with all the conditions of participation; (2) CMS terminates the provider agreement; or (3) The HHA reassumes management control without CMS approval. In such case, CMS initiates termination of the provider agreement and may impose additional sanctions. (4) Temporary management will not exceed a period of 6 months from the date of the survey identifying noncompliance. (d) Payment of salary. (i) Is paid directly by the HHA while the temporary manager is assigned to that HHA; and (ii) Must be at least equivalent to the sum of the following: (A) The prevailing salary paid by providers for positions of this type in what the State considers to be the HHA's geographic area (prevailing salary based on the Geographic Guide by the Department of Labor (BLS Wage Data by Area and Occupation); (B) Any additional costs that would have reasonably been incurred by the HHA if such person had been in an employment relationship; and (C) Any other costs incurred by such a person in furnishing services under such an arrangement or as otherwise set by the State. (2) An HHA's failure to pay the salary and other costs of the temporary manager described in paragraph (d)(1) of this section is considered a failure to relinquish authority and control to temporary management. § 488.840 Suspension of payment for all new patient admissions. (a) Application. (2) CMS will consider this sanction for any deficiency related to poor patient care outcomes, regardless of whether the deficiency poses immediate jeopardy. (b) Procedures Notices. (ii) The HHA may not charge a newly admitted HHA patient who is a Medicare beneficiary for services for which Medicare payment is suspended unless the HHA can show that, before initiating care, it gave the patient or his or her representative oral and written notice of the suspension of Medicare payment in a language and manner that the beneficiary or representative can understand. (2) Restriction. (ii) Suspension of payment for patients with new admissions will remain in place until CMS determines that the HHA has achieved substantial compliance or is involuntarily terminated with the conditions of participation, as determined by CMS. (3) Resumption of payments. (c) Duration and effect of sanction. (1) CMS determines that the HHA is in substantial compliance with all of the conditions of participation; or (2) When the HHA is terminated or CMS determines that the HHA is not in compliance with the conditions of participation at a maximum of 6 months from the date noncompliance was determined. § 488.845 Civil money penalties. (a) Application. (2) CMS may impose a civil money penalty for the number of days of immediate jeopardy. (3) A per-day and a per-instance CMP may not be imposed simultaneously for the same deficiency. (b) Amount of penalty Factors considered. (i) The factors set out at § 488.815. (ii) The size of an agency and its resources. (iii) Accurate and credible resources, such as PECOS, Medicare cost reports and Medicare/Medicaid claims information that provide information on the operation and resources of the HHA. (iv) Evidence that the HHA has a built-in, self-regulating quality assessment and performance improvement system to provide proper care, prevent poor outcomes, control patient injury, enhance quality, promote safety, and avoid risks to patients on a sustainable basis that indicates the ability to meet the conditions of participation and to ensure patient health and safety. (2) Adjustments to penalties. (i) CMS may increase a CMP in increments based on a HHA's inability or failure to correct deficiencies, the presence of a system-wide failure in the provision of quality care, or a determination of immediate jeopardy with actual harm versus immediate jeopardy with potential for harm. (ii) CMS may also decrease a CMP in increments to the extent that it finds, pursuant to a revisit, that substantial and sustainable improvements have been implemented even though the HHA is not yet in full compliance with the conditions of participation. (iii) No penalty assessment will exceed $10,000 as adjusted annually under 45 CFR part 102 for each day of noncompliance. (3) Upper range of penalty. (i) $10,000 as adjusted annually under 45 CFR part 102 per day for a deficiency or deficiencies that are immediate jeopardy and that result in actual harm. (ii) $9,000 as adjusted annually under 45 CFR part 102 per day for a deficiency or deficiencies that are immediate jeopardy and that result in a potential for harm. (iii) $8,500 as adjusted annually under 45 CFR part 102 per day for an isolated incident of noncompliance in violation of established HHA policy. (4) Middle range of penalty. (5) Lower range of penalty. (6) Per instance penalty. (7) Decreased penalty amounts. (8) Increased penalty amounts. (ii) CMS increases the per day penalty amount for deficiencies that are not corrected and found again at the time of revisit survey(s) for which a lower-level penalty amount was previously imposed. (iii) CMS may impose a more severe amount of penalties for repeated noncompliance with the same condition-level deficiency or uncorrected deficiencies from a prior survey. (c) Procedures Notice of intent. (2) Appeals Appeals procedures. (ii) Waiver of a hearing. (d) Accrual and duration of penalty. (ii) A civil money penalty for each per instance of noncompliance is imposed in a specific amount for that particular deficiency, with a maximum of $10,000 as adjusted annually under 45 CFR part 102 per day per HHA. (2) A penalty that is imposed per day and per instance of noncompliance may not be imposed simultaneously. (3) Duration of per day penalty when there is immediate jeopardy. (ii) A penalty imposed per day of noncompliance will stop accruing on the day the provider agreement is terminated or the HHA achieves substantial compliance, whichever occurs first. (4) Duration of penalty when there is no immediate jeopardy. (ii) If the HHA has not achieved compliance with the conditions of participation, CMS terminates the provider agreement. The accrual of civil money penalty stops on the day the HHA agreement is terminated or the HHA achieves substantial compliance, whichever is earlier. (e) Computation and notice of total penalty amount. (i) The amount of penalty assessed per day. (ii) The total number of days of noncompliance. (iii) The total amount due. (iv) The due date of the penalty. (v) The rate of interest to be assessed on any unpaid balance beginning on the due date, as provided in paragraph (f)(4) of this section. (2) When a civil money penalty is imposed for per instance of noncompliance, CMS sends a notice to the HHA containing all of the following information: (i) The amount of the penalty that was assessed. (ii) The total amount due. (iii) The due date of the penalty. (iv) The rate of interest to be assessed on any unpaid balance beginning on the due date, as provided in paragraph (f)(6) of this section. (3) In the case of an HHA for which the provider agreement has been involuntarily terminated and for which a civil money penalty was imposed on a per day basis, CMS sends this penalty information after one of the following actions has occurred: (i) Final administrative decision is made. (ii) The HHA has waived its right to a hearing in accordance with paragraph (c)(2)(ii) of this section. (iii) Time for requesting a hearing has expired and CMS has not received a hearing request from the HHA. (f) Due date for payment of penalty. (1) Payments are due for all civil money penalties within 15 days: (i) After a final administrative decision when the HHA achieves substantial compliance before the final decision or the effective date of termination before final decision, (ii) After the time to appeal has expired and the HHA does not appeal or fails to timely appeal the initial determination, (iii) After CMS receives a written request from the HHA requesting to waive its right to appeal the determinations that led to the imposition of a sanction, (iv) After substantial compliance is achieved, or (v) After the effective date of termination. (2) A request for hearing does not delay the imposition of any penalty; it only potentially delays the collection of the final penalty amount. (3) If an HHA waives its right to a hearing according to paragraph (c)(2)(ii) of this section, CMS will apply a 35 percent reduction to the CMP amount when: (i) The HHA achieved compliance with the conditions of participation before CMS received the written waiver of hearing; or (ii) The effective date of termination occurs before CMS received the written waiver of hearing. (4) The period of noncompliance may not extend beyond 6 months from the last day of the survey. (5) The amount of the penalty, when determined, may be deducted (offset) from any sum then or later owing by CMS or State Medicaid to the HHA. (6) Interest is assessed and accrues on the unpaid balance of a penalty, beginning on the due date. Interest is computed at the rate specified in § 405.378(d) of this chapter. (g) Penalties collected by CMS Disbursement of CMPs. (i) Based on expenditures for the FY 2007-2009 period, the initial proportions to be disbursed are 63 percent returned to the U.S. Treasury and 37 percent returned to the State Medicaid agency. (ii) Beginning one year after the effective date of this section, CMS shall annually update these proportions based on the most recent 3-year fiscal period, prior to the year in which the CMP is imposed, for which CMS determines that the relevant data are essentially complete. (iii) The portion corresponding to the Medicare payments is returned to the U.S. Department of Treasury as miscellaneous receipts. (iv) The portion corresponding to the Medicaid payments is returned to the State Medicaid agency. (2) Penalties may not be used for Survey and Certification operations nor as the State's Medicaid non-Federal medical assistance or administrative match. (h) Review of the penalty. (1) Set a penalty of zero or reduce a penalty to zero; (2) Review the exercise of discretion by CMS to impose a civil monetary penalty; and (3) Consider any factors in reviewing the amount of the penalty other than those specified in paragraph (b) of this section. [77 FR 67165, Nov. 8, 2012, as amended at 79 FR 66118, Nov. 6, 2014; 81 FR 61563, Sept. 6, 2016] § 488.850 Directed plan of correction. (a) Application. (1) Has one or more deficiencies that warrant directing the HHA to take specific actions; or (2) Fails to submit an acceptable plan of correction. (b) Procedures. (2) CMS or the temporary manager (with CMS approval) may direct the HHA to take corrective action to achieve specific outcomes within specific timeframes. (c) Duration and effect of sanction. (1) May impose one or more other sanctions set forth in § 488.820; or (2) Terminates the provider agreement. § 488.855 Directed in-service training. (a) Application. (1) The HHA has deficiencies that indicate noncompliance; (2) Education is likely to correct the deficiencies; and (3) The programs are conducted by established centers of health education and training or consultants with background in education and training with Medicare Home Health Providers, or as deemed acceptable by CMS and/or the State (by review of a copy of curriculum vitas and/or resumes/references to determine the educator's qualifications). (b) Procedures Action following training. (2) Payment. § 488.860 Continuation of payments to an HHA with deficiencies. (a) Continued payments. (1) Criteria. (i) The HHA has been imposed an alternative sanction or sanctions and termination has not been imposed. (ii) The HHA has submitted a plan of correction approved by CMS. (iii) The HHA agrees to repay the Federal government payments received under this provision if corrective action is not taken in accordance with the approved plan and timetable for corrective action. (2) CMS may terminate the HHA's provider agreement any time if the criteria in paragraph (a)(1) of this section are not met. (b) Cessation of payments for new admissions. (c) Failure to achieve compliance with the conditions of participation. § 488.865 Termination of provider agreement. (a) Effect of termination by CMS. (1) Payment to the HHA; and (2) Any alternative sanction(s). (b) Basis for termination. (1) The HHA is not in compliance with the conditions of participation. (2) The HHA fails to submit an acceptable plan of correction within the timeframe specified by CMS. (3) The HHA fails to relinquish control to the temporary manager, if that sanction is imposed by CMS. (4) The HHA fails to meet the eligibility criteria for continuation of payment as set forth in § 488.860(a)(1). (c) Notice. (d) Procedures for termination. (e) Appeal. Subpart K—[Reserved] Subpart L—Accreditation of Home Infusion Therapy Suppliers Source: 83 FR 56631, Nov. 13, 2018, unless otherwise noted. General Provisions § 488.1000 Basis and scope. (a) Regulatory basis for home infusion therapy services. (b) Statutory basis for the accreditation of home infusion therapy suppliers. (2) Section 1834(u)(5) of the Act require the Secretary to designate and approve independent organizations for the purposes of accrediting qualified home infusion therapy suppliers. (c) Scope. (1) Application and reapplication procedures for national accrediting organizations seeking approval or re-approval of authority to accredit qualified home infusion therapy suppliers. (2) Ongoing CMS oversight processes for approved accrediting organizations that accredit qualified home infusion therapy suppliers. (3) Appeal procedures for accrediting organizations that accredit qualified home infusion therapy suppliers. § 488.1005 Definitions. As used in this subpart— Immediate jeopardy National accrediting organization National in scope Qualified home infusion therapy supplier (1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs. (2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis. (3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act. (4) Meets such other requirements as the Secretary determines appropriate. Reasonable assurance Rural area Substantial allegation of non-compliance Approval and Oversight of Home Infusion Therapy Supplier Accrediting Organizations § 488.1010 Application and reapplication procedures for national home infusion therapy accrediting organizations. (a) Information submitted with application. (1) Documentation that demonstrates the organization meets the definition of a national accrediting organization under § 488.1005 as it relates to the accreditation program. (2) The Medicare provider or supplier type for which the organization is requesting approval or reapproval. (3) Documentation that demonstrates the home infusion therapy accrediting organization's ability to take into account the capacities of rural home infusion therapy suppliers (as required by section 1834(u)(5)(A)(ii) of the Act). (4) Information that demonstrates the home infusion therapy accrediting organization's knowledge, expertise, and experience in home infusion therapy. (5) A detailed crosswalk (in table format) that identifies, for each of the applicable Medicare requirements, the exact language of the organization's comparable accreditation requirements and standards. (6) A detailed description of the home infusion therapy accrediting organization's survey processes to confirm that a home infusion therapy supplier's processes are comparable to those of Medicare. This description must include all of the following: (i) The types and frequency of surveys performed, and a rationale for which accreditation requirements will be evaluated via onsite surveys and which will be evaluated via offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including an explanation of how the accrediting organization will maintain the schedule it proposes. (ii) Copies of the home infusion therapy accrediting organizations survey and audit forms, guidelines, and instructions to surveyors. (iii) Documentation demonstrating that the home infusion therapy accrediting organization's onsite survey or offsite audit reports identify, for each finding of non-compliance with accreditation standards, the comparable Medicare home infusion therapy accreditation requirements, as applicable. (iv) A description of the home infusion therapy accrediting organization's accreditation survey review process. (v) A description of the home infusion therapy accrediting organization's procedures and timelines for notifying a surveyed or audited home infusion therapy supplier of non-compliance with the home infusion therapy accreditation program's standards. (vi) A description of the home infusion therapy accrediting organization's procedures and timelines for monitoring the home infusion therapy supplier's correction of identified non-compliance with the accreditation program's standards. (vii) The ability of the home infusion therapy accrediting organization to conduct timely reviews of accreditation applications. (viii) A statement acknowledging that, as a condition for CMS approval of a national accrediting organization's accreditation program, the home infusion therapy accrediting organization agrees to provide CMS with information extracted from each home infusion therapy accreditation onsite survey, offsite audit or other evaluation strategies as part of its data submissions required under paragraph (a)(19) of this section, and, upon request from CMS, a copy of the most recent accreditation onsite survey, offsite audit, or other evaluation strategy together with any other information related to the survey as CMS may require (including corrective action plans). (ix) A statement acknowledging that the home infusion therapy accrediting organization will provide timely notification to CMS when an accreditation survey or complaint investigation identifies an immediate jeopardy as that term is defined at § 488.1005. Using the format specified by CMS, the home infusion therapy accrediting organization must notify CMS within 2 business days from the date the accrediting organization identifies the immediate jeopardy. (7) Procedures to ensure that— (i) Unannounced onsite surveys, as appropriate, will be conducted periodically, including procedures that protect against unannounced surveys becoming known to the provider or supplier in advance of the visit; or (ii) Offsite survey audits are performed to evaluate the quality of services provided which may be followed up with periodic onsite visits. (8) The criteria for determining the size and composition of the home infusion therapy accrediting organization's survey, audit and other evaluation strategy teams for individual supplier onsite surveys. The home infusion therapy accrediting organization's criteria should include, but not be limited to the following information: (i) The expected number of individual home infusion therapy supplier locations to be surveyed using an onsite survey. (ii) The number of home infusion therapy suppliers to be surveyed using off-site audits. (iii) A description of other types of home infusion therapy accreditation review activities to be used. (iv) The reasons for each type of survey (that is, initial accreditation survey, reaccreditation survey, and complaint survey). (9) The overall adequacy of the number of the home infusion therapy accrediting organization's surveyors, auditors, and other staff available to perform survey related activities, including how the organization will increase the size of the survey, audit, and other evaluation staff to match growth in the number of accredited facilities or programs while maintaining re-accreditation intervals for existing accredited facilities or programs. (10) Detailed information about the individuals who perform onsite surveys, offsite audits or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including all of the following information: (i) The number and types of professional and technical staff available for conducting onsite surveys, offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements. (ii) The education, employment, and experience requirements surveyors and auditors must meet. (iii) The content and length of the orientation program. (11) The content, frequency and types of in-service training provided to survey and audit personnel. (12) The evaluation systems used to monitor the performance of individual surveyors, auditors and survey teams. (13) The home infusion therapy accrediting organization's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions. (14) The policies and procedures used when a home infusion therapy supplier has a dispute regarding survey or audit findings, or an adverse decision. (15) Procedures for the home infusion therapy supplier to use to notify the home infusion therapy accrediting organization when the accredited home infusion therapy supplier does the either of the following: (i) Removes or ceases furnishing services for which they are accredited. (ii) Adds services for which they are not accredited. (16) The home infusion therapy accrediting organization's procedures for responding to, and investigating complaints against accredited facilities, including policies and procedures regarding referrals, when applicable, to appropriate licensing bodies, ombudsmen offices, and CMS. (17) A description of the home infusion therapy accrediting organization's accreditation status decision-making process. The home infusion therapy accrediting organization must furnish the following: (i) Its process for addressing deficiencies identified with accreditation program requirements, and the procedures used to monitor the correction of deficiencies identified during an accreditation survey and audit process. (ii) A description of all types and categories of accreditation decisions associated with the program, including the duration of each of the organization's accreditation decisions. (iii) Its policies and procedures for the granting, withholding or removal of accreditation status for facilities that fail to meet the accrediting organization's standards or requirements, assignment of less than full accreditation status or other actions taken by the organization in response to non-compliance with its standards and requirements. (iv) A statement acknowledging that the home infusion therapy accrediting organization agrees to notify CMS (in a manner CMS specifies) of any decision to revoke, terminate, or revise the accreditation status of a home infusion therapy supplier, within 3 business days from the date the organization takes an action. (18) A list of all currently accredited home infusion therapy suppliers, the type and category of accreditation, currently held by each, and the expiration date for each home infusion therapy supplier's current accreditation. (19) A schedule of all survey activity (such as onsite surveys, offsite audits and other types if survey strategies) expected to be conducted by the organization during the 6-month period following submission of an initial or renewal application. (20) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data. (21) A description of the home infusion therapy accrediting organization's data management and analysis system with respect to its surveys and accreditation decisions, including all of the following: (i) A detailed description of how the home infusion therapy accrediting organization uses its data to assure the compliance of its home infusion therapy accreditation program with the Medicare home infusion therapy accreditation program requirements. (ii) A written statement acknowledging that the home infusion therapy accrediting organization agrees to submit timely, accurate, and complete data that CMS has determined is both necessary to evaluate the accrediting organization's performance and is not unduly burdensome for the accrediting organization to submit. (A) The organization must submit necessary data according to the instructions and timeframes CMS specifies. (B) Data to be submitted includes the following: ( 1 ( 2 ( 3 ( 4 (22) The three most recent annual audited financial statements of the home infusion therapy accrediting organization that demonstrate that the organization's staffing, funding, and other resources are adequate to perform the required surveys, audits, and related activities to maintain the accreditation program. (23) A written statement acknowledging that, as a condition for approval, the home infusion therapy accrediting organization agrees to the following: (i) Voluntary termination. (ii) Involuntary termination. Federal Register (A) For both voluntary and involuntary terminations, provide a second written notification to all accredited home infusion therapy suppliers 10 calendar days prior to the organization's accreditation program effective date of termination. (B) Notify CMS, in writing (electronically or hard copy), within 2 business days of a deficiency identified in any accredited home infusion therapy supplier from any source where the deficiency poses an immediate jeopardy to the home infusion therapy supplier's beneficiaries or a hazard to the general public. (iii) Summary accreditation activity data and trends. (A) Deficiencies. (B) Complaints. (C) Terminations. (D) Withdrawals. (E) Denials. (F) Accreditation decisions. (G) Other survey-related activities as specified by CMS. (iv) Termination of an accreditation organization. (v) Notification of proposed changes. (vi) Response to a written notice from CMS. (A) The proposed changes must be submitted within 30 calendar days of the date of the written CMS notice to the home infusion therapy accrediting organization or by a date specified in the notice, whichever is later. CMS gives due consideration to a home infusion therapy accrediting organization's request for an extension of the deadline as long as it is submitted prior to the due date. (B) The proposed changes are not to be implemented without prior written notice of continued program approval from CMS, except as provided for at § 488.1040(b)(2)(ii). (24) The organization's proposed fees for accreditation, including any plans for reducing the burden and cost of accreditation to small and rural suppliers. (b) Additional information needed. (c) Withdrawing an application. (d) Notice of approval or disapproval of application. (1) The basis for the decision. (2) The effective date. (3) The term of the approval (not exceed 6 years). § 488.1015 Resubmitting a request for reapproval. (a) Except as provided in paragraph (b) of this section, a home infusion therapy accrediting organization whose request for CMS's approval or re-approval of an accreditation program has been denied, or a home infusion therapy accrediting organization that has voluntarily withdrawn an initial application, may resubmit its application if the home infusion therapy accrediting organization satisfies all of the following requirements: (1) Revises its home infusion therapy accreditation program to address the issues related to the denial of its previous request or its voluntary withdrawal. (2) Resubmits the application in its entirety. (b) If a home infusion therapy accrediting organization has requested, in accordance with § 488.1050, a reconsideration of CMS's disapproval, it may not submit a new application for approval of a home infusion therapy accreditation program until such reconsideration is administratively final. § 488.1020 Public notice and comment. CMS publishes a notice in the Federal Register (a) Proposed notice. (b) Final notice. (1) Approval or re-approval. (i) A description of how the home infusion therapy accreditation program meets or exceeds Medicare home infusion therapy accreditation program requirements. (ii) The effective date of approval (no later than the publication date of the notice). (iii) The term of the approval (6 years or less). (2) Denial. (i) How the home infusion therapy accrediting organization fails to meet Medicare home infusion therapy accreditation program requirements. (ii) The effective date of the decision. § 488.1025 Release and use of home infusion therapy accreditation surveys. The home infusion therapy accrediting organization must include, in its accreditation agreement with each supplier, an acknowledgement that the supplier agrees to release to CMS a copy of its most current accreditation survey and any information related to the survey that CMS may require, corrective action plans. (a) CMS may determine that a home infusion therapy supplier does not meet the applicable Medicare conditions or requirements on the basis of its own investigation of the accreditation survey or any other information related to the survey. (b) With the exception of home health agency surveys, general disclosure of an accrediting organization's survey information is prohibited under section 1865(b) of the Act. CMS may publically disclose an accreditation survey and information related to the survey, upon written request, to the extent that the accreditation survey and survey information are related to an enforcement action taken by CMS. § 488.1030 Ongoing review of home infusion therapy accrediting organizations. (a) Performance review. (1) The home infusion therapy accrediting organization's survey activity. (2) The home infusion therapy accrediting organization's continued fulfillment of the requirements at §§ 488.1010 and 488.1035. (b) Comparability review. (1) CMS provides the home infusion therapy accrediting organizations with written notice of the changes to the to the Medicare home infusion therapy accreditation requirements. (2) The home infusion therapy accrediting organization must make revisions to its home infusion therapy accreditation standards or survey processes which incorporate the new or revised Medicare accreditation requirements. (3) In the written notice, CMS specifies the deadline (no less than 30 calendar days) by which the home infusion therapy accrediting organization must submit its proposed revised home infusion therapy accreditation standard or survey process revisions, and the timeframe(s) for implementation of these revised home infusion therapy accreditation standards. (4) CMS may extend the submission deadline by which the accrediting organization must submit its proposed revised home infusion therapy accreditation standards and survey processes, if both of the following occur: (i) The accrediting organization submits a written request for an extension of the submission deadline. (ii) The request for extension is submitted prior to the original submission deadline. (5) After completing the comparability review of the home infusion therapy accrediting organizations revised home infusion therapy accreditation standards and survey processes, CMS shall provide written notification to the home infusion therapy accrediting organization regarding whether or not its home infusion therapy accreditation program, including the proposed revised home infusion therapy accreditation standards and implementation timeframe(s), continues to meet or exceed all applicable Medicare requirements. (6) If, no later than 60 calendar days after receipt of the home infusion therapy accrediting organization's proposed changes, CMS does not provide the written notice to the home infusion therapy accrediting organization required, then the revised home infusion therapy accreditation standards and program is deemed to meet or exceed all applicable Medicare requirements and to have continued CMS-approval. (7) If a home infusion therapy accrediting organization is required to submit a new application because CMS imposes new home infusion therapy regulations or makes significant substantive revisions to the existing home infusion therapy regulations, CMS provides notice of the decision to approve or disapprove the new application submitted by the home infusion therapy accrediting organization within the time period specified in § 488.1010(d). (8) If a home infusion therapy accrediting organization fails to submit its proposed changes to its home infusion therapy accreditation standards and survey processes within the required timeframe, or fails to implement the proposed changes that have been determined or deemed by CMS to be comparable, CMS may open an accreditation program review in accordance with paragraph (d) of this section. (c) Review of revised home infusion therapy accreditation standards submitted to CMS by an accrediting organization. (1) Provide CMS with written notice of any proposed changes in home infusion therapy accreditation standards, requirements or survey process at least 60 days prior to the proposed implementation date of the proposed changes. (2) Not implement any of the proposed changes before receiving CMS's approval, except as provided in paragraph (c)(4) of this section. (3) Provide written notice to CMS that includes all of the following: (i) A detailed description of the changes that are to be made to the organization's home infusion therapy accreditation standards, requirements and survey processes. (ii) A detailed crosswalk (in table format) that states the exact language of the organization's revised accreditation requirements and the applicable Medicare requirements for each. (4) CMS must provide a written notice to the home infusion therapy accrediting organization which states whether the home infusion therapy accreditation program, including the proposed revisions, continues or does not continue to meet or exceed all applicable Medicare home infusion therapy requirements within 60 days of receipt of the home infusion therapy accrediting organization's proposed changes. If CMS has made a finding that the home infusion therapy accrediting organization's home infusion therapy accreditation program, accreditation requirements and survey processes, including the proposed revisions does not continue to meet or exceed all applicable Medicare home infusion therapy requirements. CMS must state the reasons for these findings. (5) If, no later than 60 calendar days after receipt of the home infusion therapy accrediting organization's proposed changes, CMS does not provide written notice to the home infusion therapy accrediting organization that the home infusion therapy accreditation program, including the proposed revisions, continues or does not continue to meet or exceed all applicable Medicare home infusion therapy requirements, then the revised home infusion therapy accreditation program is deemed to meet or exceed all applicable Medicare home infusion therapy requirements and to have continued CMS approval. (6) If a home infusion therapy accrediting organization implements changes that have neither been determined nor deemed by CMS to be comparable to the applicable Medicare home infusion therapy requirements, CMS may open a home infusion therapy accreditation program review in accordance with paragraph (d) of this section. (d) CMS-approved home infusion therapy accreditation program review. (1) If a home infusion therapy accreditation program review is initiated, CMS will provide written notice to the home infusion therapy accrediting organization indicating that its CMS-approved accreditation program approval may be in jeopardy and that a home infusion therapy accreditation program review is being initiated. The notice will provide all of the following information: (i) A statement of the instances, rates or patterns of non-compliance identified, as well as other related information, if applicable. (ii) A description of the process to be followed during the review, including a description of the opportunities for the home infusion therapy accrediting organization to offer factual information related to CMS' findings. (iii) A description of the possible actions that may be imposed by CMS based on the findings of the home infusion therapy accreditation program review. (iv) The actions the home infusion therapy accrediting organization must take to address the identified deficiencies (v) The length of the accreditation program review probation period, which will include monitoring of the home infusion therapy accrediting organization's performance and implementation of the corrective action plan. The probation period is not to exceed 180 calendar days from the date that CMS approves the AOs corrective action plan. (2) CMS will review and approve the home infusion therapy accrediting organization's plan of correction for acceptability within 30 days after receipt. (3) CMS will monitor the AO's performance and implementation of the plan of correction during the probation period which is not to exceed 180 days from the date of approval of the plan of correction. (4) If CMS determines, as a result of the home infusion therapy accreditation program review or a review of an application for renewal of the accrediting organizations existing CMS-approved home infusion therapy accreditation program, that the home infusion therapy accrediting organization has failed to meet any of the requirements of this subpart, CMS may place the home infusion therapy accrediting organization's CMS-approved home infusion therapy accreditation program on an additional probation period of up to 180 calendar days subsequent to the 180-day probation period described in paragraph (d)(1)(v) of this section to implement additional corrective actions or demonstrate sustained compliance, not to exceed the home infusion therapy accrediting organization's current term of approval. In the case of a renewal application where CMS has already placed the home infusion therapy accreditation program on probation, CMS indicates that any approval of the application is conditional while the program is placed on probation. (i) Within 60 calendar days after the end of any probationary period, CMS issues a written determination to the home infusion therapy accrediting organization as to whether or not its CMS-approved home infusion therapy accreditation program continues to meet the requirements of this subpart, including the reasons for the determination. (ii) If CMS determines that the home infusion therapy accrediting organization does not meet the requirements, CMS may withdraw approval of the CMS-approved home infusion therapy accreditation program. The notice of determination provided to the home infusion therapy accrediting organization includes notice of the removal of approval, reason for the removal, including the effective date determined in accordance with paragraph (d)(4)(iii) of this section. (iii) CMS publishes in the Federal Register (e) Immediate jeopardy. Federal Register (f) Notification to home infusion therapy suppliers of withdrawal of CMS approval status. Federal Register. (g) Change of ownership. [83 FR 56631, Nov. 13, 2018, as amended at 87 FR 25428, Apr. 29, 2022] § 488.1035 Ongoing responsibilities of a CMS-approved home infusion therapy accrediting organization. A home infusion therapy accreditation organization approved by CMS must carry out the following activities on an ongoing basis: (a) Provide CMS with all of the following in written format (either electronic or hard copy): (1) Copies of all home infusion therapy accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of findings with respect to unmet CMS requirements). (2) Notice of all accreditation decisions. (3) Notice of all complaints related to providers or suppliers. (4) Information about all home infusion therapy accredited suppliers against which the home infusion therapy accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the providers or suppliers accreditation. (5) The home infusion therapy accrediting organization must provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends. (6) Notice of any proposed changes in the home infusion therapy accrediting organization's accreditation standards or requirements or survey process. If the home infusion therapy accrediting organization implements the changes before or without CMS' approval, CMS may withdraw its approval of the accrediting organization. (b) Within 30 calendar days after a change in CMS requirements, the home infusion therapy accrediting organization must submit an acknowledgment of receipt of CMS' notification to CMS. (c) The home infusion therapy accrediting organization must permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. (d) Within 2 business days of identifying a deficiency of an accredited home infusion therapy supplier that poses immediate jeopardy to a beneficiary or to the general public, the home infusion therapy accrediting organization must provide CMS with written notice of the deficiency and any adverse action implemented by the accrediting organization. (e) Within 10 calendar days after CMS' notice to a CMS-approved home infusion therapy accrediting organization that CMS intends to withdraw approval of the home infusion therapy accrediting organization, the home infusion therapy accrediting organization must provide written notice of the withdrawal to all of the home infusion therapy accrediting organization's accredited suppliers. § 488.1040 Onsite observations of home infusion therapy accrediting organization operations. (a) As part of the application review process, the ongoing review process, or the continuing oversight of a home infusion therapy accrediting organization's performance, CMS may conduct onsite inspections of the home infusion therapy accrediting organization's operations and offices at any time to verify the home infusion therapy accrediting organization's representations and to assess the home infusion therapy accrediting organization's compliance with its own policies and procedures. (b) Activities to be performed by CMS staff during the onsite inspections may include, but are not limited to the following: (1) Interviews with various accrediting organization staff. (2) Review of documents, survey files, audit tools, and related records. (3) Observation of meetings concerning the home infusion therapy accreditation process. (4) Auditing meetings concerning the accreditation process. (5) Observation of in-progress surveys and audits. (6) Evaluation of the accrediting organization's survey results and accreditation decision-making process. § 488.1045 Voluntary and involuntary termination. (a) Voluntary termination by a CMS-approved accrediting program. (b) Involuntary termination of an accrediting organization's approval by CMS. Federal Register Federal Register (c) Voluntary and involuntary terminations. (1) The accreditation status of affected home infusion therapy suppliers is considered to remain in effect until their current term of accreditation expires; (2) If the home infusion therapy supplier wishes to avoid a suspension of payment, it must provide written notice to CMS at least 60-calendar days prior to its accreditation expiration date that it has submitted an application for home infusion therapy accreditation under another CMS-approved home infusion therapy accreditation program. Failure to comply with this 60-calendar day requirement prior to expiration of their current home infusion therapy accreditation stations within could result in a suspension of payment; and (3) The home infusion therapy accrediting organization provides a second written notification to all accredited home infusion therapy suppliers ten calendar days prior to the organization's accreditation program effective date of termination. (d) Voluntary withdrawal from accreditation requested by a home infusion therapy supplier. (1) The accrediting organization must contact the home infusion therapy supplier to seek written confirmation that the home infusion therapy supplier intends to voluntarily withdraw from the home infusion therapy accreditation program. (2) The home infusion therapy accrediting organization must advise the home infusion therapy supplier, in writing, of the statutory requirement for accreditation for all home infusion therapy suppliers and the possible payment consequences for a lapse in accreditation status. (3) The home infusion therapy accrediting organization must submit their final notice of the voluntary withdrawal of accreditation by the home infusion therapy supplier to CMS by 5 business days after the request for voluntary withdrawal is ultimately processed and effective. § 488.1050 Reconsideration. (a) General rule. (b) Filing requirements. (2) The written request for reconsideration must specify the findings or issues with which the home infusion therapy accrediting organization disagrees and the reasons for the disagreement. (3) A requestor may withdraw its written request for reconsideration at any time before the issuance of a reconsideration determination. (c) CMS response to a request for reconsideration. (1) The opportunity for a hearing to be conducted by a hearing officer appointed by the Administrator of CMS and provide the accrediting organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew designation; and (2) Written notice of the time and place of the hearing at least 10 business days before the scheduled date. (d) Hearing requirements and rules. (i) Authorized representatives and staff from CMS, including, but not limited to, the following: (A) Technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts). (B) Legal counsel. (C) Non-technical witnesses with personal knowledge of the facts of the case. (ii) Representatives from the accrediting organization requesting the reconsideration including, but not limited to, the following: (A) Authorized representatives and staff from the accrediting organization. (B) Technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts). (C) Legal counsel. (D) Non-technical witnesses, such as patients and family members that have personal knowledge of the facts of the case. (2) The hearing is conducted by the hearing officer who receives testimony and documents related to the proposed action. (3) Testimony and other evidence may be accepted by the hearing officer even though such evidence may be inadmissible under the Federal Rules of Civil Procedure. (4) The hearing officer does not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. (5) Within 45 calendar days after the close of the hearing, the hearing officer will present the findings and recommendations to the accrediting organization that requested the reconsideration. (6) The written report of the hearing officer will include separate numbered findings of fact and the legal conclusions of the hearing officer. (7) The hearing officer's decision is final. Subpart M—Survey and Certification of Hospice Programs Source: 86 FR 62425, Nov. 9, 2021, unless otherwise noted. § 488.1100 Basis and scope. Sections 1812, 1814, 1822, 1861, 1864, and 1865 of the Act establish requirements for Hospice programs and to authorize surveys to determine whether they meet the Medicare conditions of participation. § 488.1105 Definitions. As used in this subpart— Abbreviated standard survey Complaint survey Condition-level deficiency Deficiency Hospice Special Focus Program (SFP) IDR Noncompliance SFP status (1) Level 1—in progress. (2) Level 2—completed successfully. (3) Level 3—terminated from the Medicare program. SFP survey Standard-level deficiency Standard survey Substantial compliance [86 FR 62425, Nov. 9, 2021, as amended at 88 FR 77879, Nov. 13, 2023] § 488.1110 Hospice program: surveys and hotline. (a) Basic period. (1) Assure the delivery of quality hospice program services by determining whether a hospice program complies with the Act and conditions of participation; and (2) Confirm that the hospice program has corrected deficiencies that were previously cited. (b) Complaints. (1) Must be conducted of a hospice program when complaints against the hospice program are reported to CMS, the State, or local agency. (2) The State, or local agency is responsible for maintaining a toll-free hotline to collect, maintain, and continually update information on Medicare-participating hospice programs including significant deficiencies found regarding patient care, corrective actions, and remedy activity during its most recent survey, and to receive complaints and answer questions about hospice programs. The State or local agency is also responsible for maintaining a unit for investigating such complaints. § 488.1115 Surveyor qualifications and prohibition of conflicts of interest. (a) Minimum qualifications. (b) Disqualifications. (1) The surveyor currently serves, or, within the previous 2 years has served, with the hospice program to be surveyed as one of the following: (i) A direct employee. (ii) An employment agency staff at the hospice program. (iii) An officer, consultant, or agent for the hospice program to be surveyed concerning compliance with conditions of participation specified in or in accordance with sections 1861(dd) of the Act. (2) The surveyor has a financial interest or an ownership interest in the hospice program to be surveyed. (3) The surveyor has an immediate family member, as defined at § 411.351 of this chapter, who has a financial interest or an ownership interest with the hospice program to be surveyed. (4) The surveyor has an immediate family member, as defined at § 411.351 of this chapter, who is a patient of the hospice program to be surveyed. § 488.1120 Survey teams. Standard surveys conducted by more than one surveyor must be conducted by a multidisciplinary team of professionals typically involved in hospice care and identified as professionals providing hospice core services at § 418.64 of this chapter. The multidisciplinary team must include a registered nurse. Surveys conducted by a single surveyor, must be conducted by a registered nurse. § 488.1125 Consistency of survey results. A survey agency or accrediting organization must provide a corrective action plan to CMS for any disparity rates that are greater than the threshold established by CMS. § 488.1130 Informal dispute resolution (IDR). (a) Opportunity to refute survey findings. (b) Failure to conduct IDR timely. (c) Revised statement of deficiencies as a result of IDR. (d) Notification. (2) The request for IDR must— (i) Be submitted in writing; (ii) Include the specific deficiencies that are disputed; and (iii) Be made within the same 10 calendar day period that the hospice program has for submitting an acceptable plan of correction. [88 FR 77879, Nov. 13, 2023] § 488.1135 Hospice Special Focus Program (SFP). (a) Applicability. (2) SFP selection begins in CY 2024. (b) Selection criteria. (2) Hospice programs with accrediting organization deemed status placed in the SFP— (i) Do not retain deemed status; and (ii) Are placed under CMS or State survey agency jurisdiction until completion of the SFP or termination. (c) Survey and enforcement criteria. (1) Is surveyed not less than once every 6 months by CMS or the State agency; and (2) With condition level deficiencies on any survey is subject to standard enforcement actions and may be subject to progressive enforcement remedies at the discretion of CMS. (d) Completion criteria. (e) Termination criteria. (2) CMS may consider termination from the Medicare program in accordance with § 488.1225 if any survey results in an immediate jeopardy citation while the hospice is in the SFP. (f) Public reporting. (1) A subset of 10 percent of hospice programs based on the highest aggregate scores as determined by the algorithm used by CMS. (2) Hospice SFP selection from the list in paragraph (f)(1) of this section as determined by CMS. (3) SFP status as defined in § 488.1105. [88 FR 77879, Nov. 13, 2023] Subpart N—Enforcement Remedies for Hospice Programs With Deficiencies Source: 86 FR 62425, Nov. 9, 2021, unless otherwise noted. § 488.1200 Statutory basis. Section 1822 of the Act authorizes the Secretary to take actions to remove and correct deficiencies in a hospice program through an enforcement remedy or termination or both. This section specifies that these remedies are in addition to any others available under State or Federal law, and, except for the final determination of civil money penalties, are imposed prior to the conduct of a hearing. § 488.1205 Definitions. As used in this subpart— Directed plan of correction Immediate jeopardy New admission Per instance Plan of correction Repeat deficiency Temporary management § 488.1210 General provisions. (a) Purpose of remedies. (b) Basis for imposition of remedies. (c) Number of remedies. (d) Plan of correction requirement. (e) Notification requirements Notice of intent. (2) Final notice. (3) Date of enforcement action. (f) Appeals. (2) A pending hearing does not delay the effective date of a remedy, including termination, against a hospice program. Remedies continue to be in effect regardless of the timing of any appeals proceedings. § 488.1215 Factors to be considered in selecting remedies. CMS bases its choice of remedy or remedies on consideration of one or more factors that include, but are not limited to, the following: (a) The extent to which the deficiencies pose immediate jeopardy to patient health and safety. (b) The nature, incidence, manner, degree, and duration of the deficiencies or noncompliance. (c) The presence of repeat deficiencies, the hospice program's overall compliance history and any history of repeat deficiencies at either the parent hospice program or any of its multiple locations. (d) The extent to which the deficiencies are directly related to a failure to provide quality patient care. (e) The extent to which the hospice program is part of a larger organization with performance problems. (f) An indication of any system-wide failure to provide quality care. § 488.1220 Available remedies. The following enforcement remedies are available instead of, or in addition to, termination of the hospice program's provider agreement under § 489.53 of this chapter, for a period not to exceed 6 months: (a) Civil money penalties. (b) Suspension of payment for all new patient admissions. (c) Temporary management of the hospice program. (d) Directed plan of correction. (e) Directed in-service training. § 488.1225 Action when deficiencies pose immediate jeopardy. (a) Immediate jeopardy. (1) CMS immediately terminates the hospice program provider agreement in accordance with § 489.53 of this chapter. (2) CMS terminates the hospice program provider agreement no later than 23 calendar days from the last day of the survey, if the immediate jeopardy has not been removed by the hospice program. (3) In addition to a termination, CMS may impose one or more enforcement remedies, as appropriate. (b) 2-calendar day notice. (c) Transfer of care. § 488.1230 Action when deficiencies are at the condition-level but do not pose immediate jeopardy. (a) Noncompliance with conditions of participation. (1) Terminates the hospice program's provider agreement. (2) Imposes one or more enforcement remedies set forth in § 488.1220(a) through (e) in lieu of termination, for a period not to exceed 6 months. (b) 15-calendar day notice. (c) Not meeting criteria for continuation of payment. (d) Termination timeframe when there is no immediate jeopardy. (e) Transfer of care. § 488.1235 Temporary management. (a) Application. (b) Procedures Notice of intent. (2) Termination. (c) Duration and effect of remedy. (1) CMS determines that the hospice program has achieved substantial compliance and has the management capability to ensure continued compliance with all the conditions of participation. (2) CMS terminates the provider agreement. (3) The hospice program resumes management control without CMS approval. In this case, CMS initiates termination of the provider agreement and may impose additional remedies. (4) Temporary management will not exceed a period of 6 months from the date of the survey identifying noncompliance. (d) Payment of salary. (i) Is paid directly by the hospice program while the temporary manager is assigned to that hospice program. (ii) Must be at least equivalent to the sum of the following: (A) The prevailing salary paid by providers for positions of this type in what the State considers to be the hospice program's geographic area (prevailing salary based on the Bureau of Labor Statistics, National Occupational Employment and Wage Estimates). (B) Any additional costs that would have reasonably been incurred by the hospice program if such person had been in an employment relationship. (C) Any other costs incurred by such a person in furnishing services under such an arrangement or as otherwise set by the State. (2) A hospice program's failure to pay the salary and other costs of the temporary manager described in paragraph (d)(1) of this section is considered a failure to relinquish authority and control to temporary management. § 488.1240 Suspension of payment for all new patient admissions. (a) Application. (2) CMS considers the remedy in paragraph (a)(1) of this section for any deficiency related to poor patient care outcomes, regardless of whether the deficiency poses immediate jeopardy. (b) Procedures Notice of intent. (ii) The hospice program may not charge a newly admitted hospice patient who is a Medicare beneficiary for services for which Medicare payment is suspended unless the hospice program can show that, before initiating care, it gave the patient or his or her representative oral and written notice of the suspension of Medicare payment in a language and manner that the beneficiary or representative can understand. (2) Restriction. (ii) The suspension of payment for all new admissions remains in place until CMS determines that the hospice program has achieved substantial compliance with the conditions of participation or is terminated, as determined by CMS. (3) Resumption of payments. (c) Duration and effect of remedy. (1) CMS determines that the hospice program has achieved substantial compliance with all of the conditions of participation. (2) When the hospice program is terminated or CMS determines that the hospice program is not in compliance with the conditions of participation at a maximum of 6 months from the date of the survey identifying the noncompliance. § 488.1245 Civil money penalties. (a) Application. (2) CMS may impose a civil money penalty for the number of days of immediate jeopardy. (3) A per-day and a per-instance civil money penalty (CMP) may not be imposed simultaneously for the same deficiency in conjunction with a survey. (4) CMS may impose a civil money penalty for the number of days of noncompliance since the last standard survey, including the number of days of immediate jeopardy. (b) Amount of penalty Factors considered. (i) The factors set out at § 488.1215. (ii) The size of a hospice program and its resources. (iii) Evidence that the hospice program has a built-in, self-regulating quality assessment and performance improvement system to provide proper care, prevent poor outcomes, control patient injury, enhance quality, promote safety, and avoid risks to patients on a sustainable basis that indicates the ability to meet the conditions of participation and to ensure patient health and safety. (2) Adjustments to penalties. (i) CMS may increase a CMP in increments based on a hospice program's inability or failure to correct deficiencies, the presence of a system-wide failure in the provision of quality care, or a determination of immediate jeopardy with actual harm versus immediate jeopardy with potential for harm. (ii) CMS may also decrease a CMP in increments to the extent that it finds, in accordance with a revisit, that substantial and sustainable improvements have been implemented even though the hospice program is not yet in compliance with the conditions of participation. (iii) No penalty assessment exceeds $10,000, as adjusted annually under 45 CFR part 102, for each day a hospice program is not in substantial compliance with one or more conditions of participation. (3) Upper range of penalty. (i) $10,000, as adjusted annually under 45 CFR part 102, per day for a deficiency or deficiencies that are immediate jeopardy and that result in actual harm. (ii) $9,000, as adjusted annually under 45 CFR part 102, per day for a deficiency or deficiencies that are immediate jeopardy and that result in a potential for harm. (iii) $8,500, as adjusted annually under 45 CFR part 102, per day for a deficiency based on an isolated incident in violation of established hospice policy. (4) Middle range of penalty. (5) Lower range of penalty. (6) Per instance penalty. (7) Decreased penalty amounts. (8) Increased penalty amounts. (ii) CMS increases the per day penalty amount for deficiencies that are not corrected and found again at the time of revisit survey(s) for which a lower-level penalty amount was previously imposed. (iii) CMS may impose a more severe amount of penalties for repeated noncompliance with the same condition-level deficiency or uncorrected deficiencies from a prior survey. (c) Procedures Notice of intent. (2) Appeals Appeals procedures. (ii) Waiver of a hearing. (d) Accrual and duration of penalty Accrual of per day penalty. (ii) A civil money penalty for each per instance of noncompliance is imposed in a specific amount for that particular deficiency, with a maximum of $10,000 per day per hospice program. (2) Duration of per day penalty when there is immediate jeopardy. (ii) A penalty imposed per day of noncompliance will stop accruing on the day the provider agreement is terminated or the hospice program achieves substantial compliance, whichever occurs first. (3) Duration of penalty when there is no immediate jeopardy. (ii) If the hospice program has not achieved compliance with the conditions of participation within 6 months following the last day of the survey, CMS terminates the provider agreement. The accrual of civil money penalty stops on the day the hospice program agreement is terminated or the hospice program achieves substantial compliance, whichever is earlier. (e) Computation and notice of total penalty amount. (i) The amount of penalty assessed per day. (ii) The total number of days of noncompliance. (iii) The total amount due. (iv) The due date of the penalty. (v) The rate of interest to be assessed on any unpaid balance beginning on the due date, as provided in paragraph (f)(6) of this section. (2) When a civil money penalty is imposed per instance of noncompliance, once the administrative determination is final, CMS sends a final notice to the hospice program containing all of the following information: (i) The amount of the penalty that was assessed. (ii) The total amount due. (iii) The due date of the penalty. (iv) The rate of interest to be assessed on any unpaid balance beginning on the due date, as provided in paragraph (f)(6) of this section. (3) In the case of a hospice program for which the provider agreement has been involuntarily terminated, CMS sends the final notice after one of the following actions has occurred: (i) The administrative determination is final. (ii) The hospice program has waived its right to a hearing in accordance with paragraph (c)(2)(ii) of this section. (iii) Time for requesting a hearing has expired and the hospice program has not requested a hearing. (f) Due date for payment of penalty. (1) Payments are due for all civil money penalties within 15 calendar days of any of the following: (i) After a final administrative decision when the hospice program achieves substantial compliance before the final decision or the effective date of termination occurs before the final decision. (ii) After the time to appeal has expired and the hospice program does not appeal or fails to timely appeal the initial determination. (iii) After CMS receives a written request from the hospice program requesting to waive its right to appeal the determinations that led to the imposition of a remedy. (iv) After the effective date of termination. (2) A request for hearing does not delay the imposition of any penalty; it only potentially delays the collection of the final penalty amount. (3) If a hospice program waives its right to a hearing according to paragraph (c)(2)(ii) of this section, CMS applies a 35 percent reduction to the CMP amount for any of the following: (i) The hospice program achieved compliance with the conditions of participation before CMS received the written waiver of hearing. (ii) The effective date of termination occurs before CMS received the written waiver of hearing. (4) The period of noncompliance may not extend beyond 6 months from the last day of the survey. (5) The amount of the penalty, when determined, may be deducted (offset) from any sum then or later owing by CMS or State Medicaid to the hospice program. (6) Interest is assessed and accrues on the unpaid balance of a penalty, beginning on the due date. Interest is computed at the rate specified in § 405.378(d) of this chapter. (g) Review of the penalty. (1) Set a penalty of zero or reduce a penalty to zero. (2) Review the exercise of discretion by CMS to impose a civil monetary penalty. (3) Consider any factors in reviewing the amount of the penalty other than those specified in paragraph (b) of this section. § 488.1250 Directed plan of correction. (a) Application. (1) Has one or more condition-level deficiencies that warrant directing the hospice program to take specific actions; or (2) Fails to submit an acceptable plan of correction. (b) Procedures. (2) CMS or the temporary manager (with CMS approval) may direct the hospice program to take corrective action to achieve specific outcomes within specific timeframes. (c) Duration and effect of remedy. (1) May impose one or more other remedies set forth in § 488.1220. (2) Terminates the provider agreement. § 488.1255 Directed in-service training. (a) Application. (1) The hospice program has condition-level deficiencies. (2) Education is likely to correct the deficiencies. (3) The programs are conducted by established centers of health education and training or consultants with background in education and training with Medicare hospice providers, or as deemed acceptable by CMS or the State (by review of a copy of curriculum vitas or resumes and references to determine the educator's qualifications). (b) Procedures Notice of intent. (2) Action following training. (3) Payment. § 488.1260 Continuation of payments to a hospice program with deficiencies. (a) Continued payments. (1) Criteria. (i) An enforcement remedy, or remedies, has been imposed on the hospice program and termination has not been imposed. (ii) The hospice program has submitted a plan of correction approved by CMS. (iii) The hospice program agrees to repay the Federal Government payments received under this paragraph (a) if corrective action is not taken in accordance with the approved plan and timetable for corrective action. (2) Termination. (b) Cessation of payments for new admissions. (c) Failure to achieve compliance with the conditions of participation. § 488.1265 Termination of provider agreement. (a) Effect of termination by CMS. (1) Payment to the hospice program; and (2) Any enforcement remedy. (b) Basis for termination. (1) The hospice program is not in compliance with the conditions of participation. (2) The hospice program fails to submit an acceptable plan of correction within the timeframe specified by CMS. (3) The hospice program fails to relinquish control to the temporary manager, if that remedy is imposed by CMS. (4) The hospice program fails to meet the eligibility criteria for continuation of payment as set forth in § 488.1260(a)(1). (c) Notice. (d) Procedures for termination. (e) Payment post termination. (f) Appeal.

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