Title 42—Public Health--Volume 1
PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
§ 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.
§ 488.414   Action when there is repeated substandard quality of care.
(a) General. If a facility has been found to have provided substandard quality of care on the last three consecutive standard surveys, as defined in § 488.305, regardless of other remedies provided—
(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. For purposes of this section, repeated noncompliance is based on the repeated finding of substandard quality of care and not on the basis that the substance of the deficiency or the exact tag number for the deficiency was repeated.
(c) Standard surveys to which this provision applies. Standard surveys completed by the State survey agency on or after October 1, 1990, are used to determine whether the threshold of three consecutive standard surveys is met.
(d) Program participation. (1) The determination that a certified facility has repeated instances of substandard quality of care is made without regard to any variances in the facility's program participation (that is, any standard survey completed for Medicare, Medicaid or both programs will be considered).
(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. (1) If a penalty is imposed for repeated substandard quality of care, it will continue until the facility has demonstrated to the satisfaction of CMS or the State that it is in substantial compliance with the requirements and that it will remain in substantial compliance with the requirements for a period of time specified by CMS or the State.
(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. Temporary management means the temporary appointment by CMS or the State of a substitute facility manager or administrator with authority to hire, terminate or reassign staff, obligate facility funds, alter facility procedures, and manage the facility to correct deficiencies identified in the facility's operation.
(b) Qualifications. The temporary manager must—
(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. The temporary manager's 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 —(1) Termination of provider agreement. If a facility fails to relinquish authority to the temporary manager as described in this section, CMS will or the State must terminate the provider agreement in accordance with § 488.456.
(2) Failure to pay salary of temporary manager. A facility's failure to pay the salary of the temporary manager is considered a failure to relinquish authority to temporary management.
(e) Duration of temporary management. Temporary management ends when the facility meets any of the conditions specified in § 488.454(c).
§ 488.417   Denial of payment for all new admissions.
(a) Optional denial of payment. Except as specified in paragraph (b) of this section, CMS or the State may deny payment for all new admissions when a facility is not in substantial compliance with the requirements, as defined in § 488.401, as follows:
(1) Medicare facilities. In the case of Medicare facilities, CMS may deny payment to the facility.
(2) Medicaid facilities. In the case of 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. CMS does or the State must deny payment for all new admissions when—
(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. When a facility has repeated instances of substandard quality of care, payments to the facility or, under Medicaid, CMS payments to the State on behalf of the facility, resume on the date that—
(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. When a facility does not have repeated instances of substandard quality of care, payments to the facility or, under Medicaid, CMS payments to the State on behalf of the facility, resume prospectively on the date that the facility achieves substantial compliance, as indicated by a revisit or written credible evidence acceptable to CMS (under Medicare) or the State (under Medicaid).
(e) Restriction. No payments to a facility or, under Medicaid, CMS payments to the State on behalf of the facility, are made for the period between the date that the—
(1) Denial of payment remedy is imposed; and
(2) Facility achieves substantial compliance, as determined by CMS or the State.
§ 488.418   Secretarial authority to deny all payments.
(a) CMS option to deny all payment. If a facility has not met a requirement, in addition to the authority to deny payment for all new admissions as specified in § 488.417, CMS may deny any further payment for all Medicare residents in the facility and to the State for all Medicaid residents in the facility.
(b) Prospective resumption of payment. Except as provided in paragraphs (d) and (e) of this section, if the facility achieves substantial compliance, CMS resumes payment prospectively from the date that it verifies as the date that the facility achieved substantial compliance.
(c) Restriction on payment after denial of payment is imposed. If payment to the facility or to the State resumes after denial of payment for all residents, no payment is made for the period between the date that—
(1) Denial of payment was imposed; and
(2) CMS verifies as the date that the facility achieved substantial compliance.
(d) Retroactive resumption of payment. Except when a facility has repeated instances of substandard quality of care, as specified in paragraph (e) of this section, when CMS or the State finds that the facility was in substantial compliance before the date of the revisit, or before CMS or the survey agency received credible evidence of such compliance, payment is resumed on the date that substantial compliance was achieved, as determined by CMS.
(e) Resumption of payment—repeated instances of substandard care. When CMS denies payment for all Medicare residents for repeated instances of substandard quality of care, payment is resumed when—
(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.
§ 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. CMS or the State agency may require the staff of a facility to attend an inservice training program if—
(1) The facility has a pattern of deficiencies that indicate noncompliance; and
(2) Education is likely to correct the deficiencies.
(b) Action following training. After the staff has received inservice training, if the facility has not achieved substantial compliance, CMS or the State may impose one or more other remedies specified in § 488.406.
(c) Payment. The facility pays for directed inservice training.
§ 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. In an emergency, the State has the authority to—
(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. When the State or CMS terminates a facility's provider agreement, the State will arrange for the safe and orderly transfer of all Medicare and Medicaid residents to another facility, in accordance with § 483.70(l) of this chapter.
(c) Required notifications when a facility's provider agreement is terminated. When the State or CMS terminates a facility's provider agreement, CMS determines the appropriate date for notification, in accordance with § 483.70(l) of this chapter.
§ 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.
§ 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. CMS retains ultimate authority for the survey findings and imposition of civil money penalties, but provides an opportunity for independent informal dispute resolution within 30 days of notice of imposition of a civil money penalty that will be placed in escrow in accordance with paragraph (b) of this section. An independent informal dispute resolution will—
(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. (1) For both per day and per instance civil money penalties, CMS may collect and place the imposed civil money penalties in an escrow account on whichever of the following occurs first:
(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. CMS will maintain collected civil money penalties in an escrow account pending the resolution of any administrative appeal of the deficiency findings that comprise the basis for the civil monetary penalty imposition. CMS will retain the escrowed funds on an on-going basis and, upon a final administrative decision, will either return applicable funds in accordance with paragraph (d)(2) of this section or, in the case of an unsuccessful administrative appeal, will periodically disburse the funds to States or other entities in accordance with § 488.433.
(d) When a facility requests a hearing. (1) A facility must request a hearing on the determination of the noncompliance that is the basis for imposition of the civil money penalty as specified in § 498.40 of this chapter.
(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.
§ 488.432   Civil money penalties imposed by the State: NF-only.
(a) When a facility requests a hearing. (1) When the State imposes a civil money penalty against a non-State operated NF that is not subject to imposition of remedies by CMS, the facility must request a hearing on the determination of noncompliance that is the basis for imposition of the civil money penalty within the time specified in § 431.153 of this chapter.
(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. (1) If a facility does not request a hearing in accordance with paragraph (a) of this section, the State initiates collection of the penalty when the facility—
(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. If a facility does not request a hearing in accordance with paragraph (a) of this section, the State initiates collection of the penalty when the time frame for requesting a hearing expires.
(c) When a facility waives a hearing. (1) If a facility waives its right to a hearing as specified in § 488.436, the State initiates collection of civil money penalty imposed per day 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.
(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.
§ 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.
§ 488.434   Civil money penalties: Notice of penalty.
(a) CMS notice of penalty. (1) CMS sends a written notice of the penalty to the facility for all facilities except non-State operated NFs when the State is imposing the penalty.
(2) Content of notice. The notice that CMS sends includes—
(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. (1) The State must notify the facility in accordance with State procedures for all non-State operated NFs when the State takes the action.
(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.
§ 488.436   Civil money penalties: Waiver of hearing, reduction of penalty amount.
(a) Constructive waiver of a hearing. A facility is considered to have waived its right to a hearing after 60 days from the date of the notice imposing the civil money penalty if CMS has not received a request for a hearing from the facility.
(b) Reduction of penalty amount. (1) If the facility waives its right to a hearing in accordance with the procedures specified in paragraph (a) of this section, CMS or the State reduces the civil money penalty by 35 percent, as long as the civil money penalty has not also been reduced by 50 percent under § 488.438.
(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.
§ 488.438   Civil money penalties: Amount of penalty.
(a) Amount of penalty. (1) The penalties are within the following ranges, set at $50 increments:
(i) Upper range. Penalties in the range of $3,050-$10,000 as adjusted annually under 45 CFR part 102 per day are imposed for deficiencies constituting immediate jeopardy, and as specified in paragraph (d)(2) of this section.
(ii) Upper range. Penalties in the range of $50-$3,000 as adjusted annually under 45 CFR part 102 per day are imposed for deficiencies that do not constitute immediate jeopardy, but either caused actual harm, or caused no actual harm, but have the potential for more than minimal harm.
(2) Per instance penalty. When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance.
(b) Basis for penalty amount. The amount of penalty is based on CMS's or the State's assessment of factors listed in paragraph (f) of this section.
(c) Decreased penalty amounts. (1) Except as specified in paragraph (d)(2) of this section, if immediate jeopardy is removed, but the noncompliance continues, CMS or the State will shift the penalty amount imposed per day to the lower range.
(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. (1) Before a hearing requested in accordance with § 488.431(d) or § 488.432(a), CMS or the State may propose to increase the per day penalty amount for facility noncompliance which, after imposition of a lower level penalty amount, becomes sufficiently serious to pose immediate jeopardy.
(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. When an administrative law judge or State hearing officer (or higher administrative review authority) finds that the basis for imposing a civil money penalty exists, as specified in § 488.430, the administrative law judge or State hearing officer (or higher administrative review authority) may not—
(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. In determining the amount of penalty, CMS does or the State must take into account the following factors:
(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 for purposes of this paragraph includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating circumstance in reducing the amount of the penalty.
§ 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. (1) In the case of noncompliance that does not pose immediate jeopardy, the daily accrual of per day civil money penalties is imposed for the days of noncompliance prior to the notice specified in § 488.434 and an additional period of no longer than 6 months following the last day of the survey.
(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.
§ 488.442   Civil money penalties: Due date for payment of penalty.
(a) When payments are due for a civil money penalty. (1) Payment for a civil money penalty is due in accordance with § 488.431 of this chapter for CMS-imposed penalties and 15 days after the State initiates collection pursuant to § 488.432 of this chapter for State-imposed penalties, except as provided in paragraphs (a)(2) and (3) of this section.
(2) After the facility waives its right to a hearing in accordance with § 488.436(a). Except as provided for in § 488.431, a civil money penalty is due 75 days after the notice of the penalty in accordance with § 488.436 and a hearing request was not received when:
(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. A civil money penalty payment is due 15 days after the effective date of termination, if that date is earlier than the date specified in paragraph (a)(1)of this section.
(b) [Reserved]
(c) Deduction of penalty from amount owed. The amount of the penalty, when determined, may be deducted from any sum then or later owing by CMS or the State to the facility.
(d) Interest —(1) Assessment. Interest is assessed on the unpaid balance of the penalty, beginning on the due date.
(2) Medicare interest. Medicare rate of interest is the higher of—
(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 by HHS under 45 CFR 30.13(a)); or
(ii) The current value of funds (published annually in the Federal Register by the Secretary of the Treasury, subject to quarterly revisions).
(3) Medicaid interest. The interest rate for Medicaid is determined by the State.
(e) Penalties collected by CMS. Civil money penalties and corresponding interest collected by CMS from—
(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. Civil money penalties collected from dually participating facilities are deposited and disbursed in accordance with § 488.433 and returned to the State in proportion commensurate with the relative proportions of Medicare and Medicaid beds at the facility actually in use by residents covered by the respective programs on the date the civil money penalty begins to accrue.
(g) Penalties collected by the State. Civil money penalties collected by the State must be applied to the protection of the health or property of residents of facilities that the State or CMS finds noncompliant, such as—
(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.
§ 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.
§ 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. A minimum of $1,000 for the first occurrence.
(2) Increased amount. An amount equal to $500 added to the previously imposed civil money penalty amount for each subsequent occurrence, not to exceed the maximum amount set forth in § 488.408(d)(1)(iii).
(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.
§ 488.450   Continuation of payments to a facility with deficiencies.
(a) Criteria. (1) CMS may continue payments to a facility not in substantial compliance for the periods specified in paragraph (c) of this section if the following criteria are met:
(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. If termination is not sought, either by itself or along with another remedy or remedies, or any of the criteria set forth in paragraph (a)(1) of this section are not met or agreed to by either the facility or the State, the facility or State will receive no Medicare or Federal Medicaid payments, as applicable, from the last day of the survey.
(c) Period of continued payments —(1) Non-compliance. If the conditions in paragraph (a)(1) of this section are met, CMS may continue payments to a Medicare facility or the State for a Medicaid facility with noncompliance that does not constitute immediate jeopardy for up to 6 months from the last day of the survey.
(2) Facility closure. In the case of a facility closure, the Secretary may, as the Secretary determines appropriate, continue to make payments with respect to residents of a long-term care facility that has submitted a notification of closure during the period beginning on the date such notification is submitted to CMS and ending on the date on which the residents are successfully relocated.
(d) Failure to achieve substantial compliance. If the facility does not achieve substantial compliance by the end of the period specified in paragraph (c) of this section,
(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.
§ 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. (1) The State's finding of noncompliance takes precedence when—
(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. (1) CMS's decision to terminate the participation of a facility takes precedence when—
(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. The State's timing of termination takes precedence if it does not occur later than 6 months after the last day of the survey when both CMS and the State find that—
(1) A facility is not in substantial compliance; and
(2) The facility's participation should be terminated.
(d) Disagreement over remedies. (1) When CMS or the State, but not both, establishes one or more remedies, in addition to or as an alternative to termination, the additional or alternative remedies will also apply when—
(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. When CMS and the State establish one or more remedies, in addition to or as an alternative to termination, only the CMS remedies apply when both CMS and the State find that a facility has not achieved substantial compliance.
(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.
§ 488.456   Termination of provider agreement.
(a) Effect of termination. Termination of the provider agreement ends—
(1) Payment to the facility; and
(2) Any alternative remedy.
(b) Basis for termination. (1) CMS and the State may terminate a facility's provider agreement if a facility—
(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. Before terminating a provider agreement, CMS does and the State must notify the facility and the public—
(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. (1) CMS terminates the provider agreement in accordance with procedures set forth in § 489.53 of this chapter; and
(2) The State must terminate the provider agreement of a NF in accordance with procedures specified in parts 431 and 442 of this chapter.
§ 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. CMS may, as an alternative to termination of Medicare coverage, impose one of the sanctions specified in paragraph (b) of this section if CMS finds that—
(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. The alternative sanctions that CMS may apply in the circumstances specified in paragraph (a) of this section include the following:
(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. An alternative sanction remains in effect until CMS finds that the supplier is in substantial compliance with the requirement to cooperate in the network plans and goals, or terminates coverage of the supplier's services for lack of compliance.
§ 488.608   Notice of alternative sanction and appeal rights: Termination of coverage.
(a) Notice of alternative sanction. CMS gives the supplier and the general public notice of the alternative sanction and of the effective date of the sanction. The effective date of the alternative sanction is at least 30 days after the date of the notice.
(b) Appeal rights. Termination of Medicare coverage of a supplier's ESRD services because the supplier no longer meets the conditions for coverage of its services is an initial determination appealable under part 498 of this chapter.
§ 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.
§ 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 means a focused survey other than a standard survey that gathers information on an HHA's compliance with fewer specific standards or conditions of participation. An abbreviated standard survey may be based on complaints received, a change of ownership or management, or other indicators of specific concern such as reapplication for Medicare billing privileges following a deactivation.
Complaint survey means a survey that is conducted to investigate specific allegations of noncompliance.
Condition-level deficiency means noncompliance as described in § 488.24 of this part.
Deficiency is a violation of the Act and regulations contained in part 484, subparts A through C of this chapter, is determined as part of a survey, and can be either standard or condition-level.
Extended survey means a survey that reviews additional conditions of participation not examined during a standard survey. It may be conducted at any time but must be conducted when substandard care is identified.
Noncompliance means any deficiency found at the condition-level or standard-level.
Partial extended survey means a survey conducted to determine if deficiencies and/or deficient practice(s) exist that were not fully examined during the standard survey. The surveyors may review any additional requirements which would assist in making a compliance finding.
Standard-level deficiency means noncompliance with one or more of the standards that make up each condition of participation for HHAs.
Standard survey means a survey conducted in which the surveyor reviews the HHA's compliance with a select number of standards and/or conditions of participation in order to determine the quality of care and services furnished by an HHA as measured by indicators related to medical, nursing, and rehabilitative care.
Substandard care means noncompliance with one or more conditions of participation identified on a standard survey, including deficiencies which could result in actual or potential harm to patients of an HHA.
Substantial compliance means compliance with all condition-level requirements, as determined by CMS or the State.
§ 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. The purpose of an extended survey is:
(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. An extended survey must be conducted not later than 14 calendar days after completion of a standard survey which found that a HHA was out of compliance with a condition of participation.
§ 488.725   Unannounced surveys.
(a) Basic rule. All HHA surveys must be unannounced and conducted with procedures and scheduling that renders the onsite surveys as unpredictable in their timing as possible.
(b) State survey agency's scheduling and surveying procedures. CMS reviews each survey agency's scheduling and surveying procedures and practices to assure that the survey agency has taken all reasonable steps to avoid giving notice of a survey through the scheduling procedures and conduct of the surveys.
(c) Civil money penalties. Any individual who notifies an HHA, or causes an HHA to be notified, of the time or date on which a standard survey is scheduled to be conducted is subject to a Federal civil money penalty not to exceed $2,000 as adjusted annually under 45 CFR part 102.
§ 488.730   Survey frequency and content.
(a) Basic period. Each HHA must be surveyed not later than 36 months after the last day of the previous standard survey. Additionally, a survey may be conducted as frequently as necessary to—
(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. A standard survey or an abbreviated standard survey may be conducted within 2 months of a change, or knowledge of a change, in any of the following:
(1) Ownership;
(2) Administration; or,
(3) Management of the HHA.
(c) Complaints. A standard survey, or abbreviated standard survey—
(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. Surveys must be conducted by individuals who meet minimum qualifications prescribed by CMS. In addition, before any State or Federal surveyor may serve on an HHA survey team (except as a trainee), he/she must have successfully completed the relevant CMS-sponsored Basic HHA Surveyor Training Course and any associated course prerequisites. All surveyors must follow the principles set forth in § 488.24 through § 488.28 according to CMS policies and procedures for determining compliance with the conditions of participation.
(b) Disqualifications. Any of the following circumstances disqualifies a surveyor from surveying a particular agency:
(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. Upon the provider's receipt of an official statement of deficiencies, HHAs are afforded the option to request an informal opportunity to dispute condition-level survey findings.
(b) Failure to conduct IDR timely. Failure of CMS or the State, as appropriate, to complete IDR shall not delay the effective date of any enforcement action.
(c) Revised statement of deficiencies as a result of IDR. If any findings are revised or removed by CMS or the State based on IDR, the official statement of deficiencies is revised accordingly and any enforcement actions imposed solely as a result of those cited deficiencies are adjusted accordingly.
(d) Notification. When the survey findings indicate a condition-level deficiency, CMS or the State, as appropriate, must provide the agency with written notification of the opportunity for participating in an IDR process at the time the official statement of deficiencies is issued. The request for IDR must be submitted in writing to the State or CMS, must include the specific deficiencies that are disputed, and must be made within the same 10 calendar day period that the HHA has for submitting an acceptable plan of correction.
§ 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 means CMS or the temporary manager (with CMS/SA approval) may direct the HHA to take specific corrective action to achieve specific outcomes within specific timeframes.
Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause serious injury, harm, impairment, or death to a patient(s).
New admission means an individual who becomes a patient or is readmitted to the HHA on or after the effective date of a suspension of payment sanction.
Per instance means a single event of noncompliance identified and corrected through a survey, for which the statute authorizes CMS to impose a sanction.
Plan of correction means a plan developed by the HHA and approved by CMS that is the HHA's written response to survey findings detailing corrective actions to cited deficiencies and specifies the date by which those deficiencies will be corrected.
Repeat deficiency means a condition-level citation that is cited on the current survey and is substantially the same as or similar to, a finding of a standard-level or condition-level deficiency citation cited on the most recent previous standard survey or on any intervening survey since the most recent standard survey.
Temporary management means the temporary appointment by CMS or by a CMS authorized agent, of a substitute manager or administrator based upon qualifications described in §§ 484.105(b) and 484.115 of this chapter. The HHA's governing body must ensure that the temporary manager has authority to hire, terminate or reassign staff, obligate funds, alter procedures, and manage the HHA to correct deficiencies identified in the HHA's operation.
§ 488.810   General provisions.
(a) Purpose of sanctions. The purpose of sanctions is to ensure prompt compliance with program requirements in order to protect the health and safety of individuals under the care of an HHA.
(b) Basis for imposition of sanctions. When CMS chooses to apply one or more sanctions specified in § 488.820, the sanctions are applied on the basis of noncompliance with one or more conditions of participation found through a survey and may be based on failure to correct previous deficiency findings as evidenced by repeat deficiencies.
(c) Number of sanctions. CMS may apply one or more sanctions for each deficiency constituting noncompliance or for all deficiencies constituting noncompliance.
(d) Extent of sanctions imposed. When CMS imposes a sanction, the sanction applies to the parent HHA and its respective branch offices.
(e) Plan of correction requirement. Regardless of which sanction is applied, a non-compliant HHA must submit a plan of correction for approval by CMS.
(f) Notification requirements —(1) Notice. CMS provides written notification to the HHA of the intent to impose the sanction.
(2) Date of enforcement action. The notice periods specified in § 488.825(b) and § 488.830(b) begin the day after the HHA receives the notice.
(g) Appeals. (1) The provisions of part 498 of this chapter apply when the HHA requests a hearing on a determination of noncompliance leading to the imposition of a sanction, including termination of the provider agreement.
(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. If there is immediate jeopardy to the HHA's patient health or safety—
(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. Except for civil money penalties, for all sanctions specified in § 488.820 that are imposed when there is immediate jeopardy, notice must be given at least 2 calendar days before the effective date of the enforcement action.
(c) Transfer of care. An HHA, if its provider agreement terminated, is responsible for providing information, assistance, and arrangements necessary for the proper and safe transfer of patients to another local HHA within 30 days of termination. The State must assist the HHA in the safe and orderly transfer of care and services for the patients to another local HHA.
§ 488.830   Action when deficiencies are at the condition-level but do not pose immediate jeopardy.
(a) Noncompliance. If the HHA is no longer in compliance with the conditions of participation, either because the deficiency or deficiencies substantially limit the provider's capacity to furnish adequate care but do not pose immediate jeopardy, have a condition-level deficiency or deficiencies that do not pose immediate jeopardy, or because the HHA has repeat noncompliance that results in a condition-level deficiency based on the HHA's failure to correct and sustain compliance, CMS will:
(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. Except for civil money penalties, for all sanctions specified in § 488.820 imposed when there is no immediate jeopardy, notice must be given at least 15 calendar days before the effective date of the enforcement action. The requirements of the notice are set forth in § 488.810(f) of this part.
(c) Not meeting criteria for continuation of payment. If an HHA does not meet the criteria for continuation of payment under § 488.860(a) of this part, CMS will terminate the HHA's provider agreement in accordance with § 488.865 of this part.
(d) Termination time frame when there is no immediate jeopardy. CMS terminates an HHA within 6 months of the last day of the survey, if the HHA is not in compliance with the conditions of participation, and the terms of the plan of correction have not been met.
(e) Transfer of care. An HHA, if its provider agreement terminated, is responsible for providing information, assistance, and arrangements necessary for the proper and safe transfer of patients to another local HHA within 30 days of termination. The State must assist the HHA in the safe and orderly transfer of care and services for the patients to another local HHA.
§ 488.835   Temporary management.
(a) Application. (1) CMS may impose temporary management of an HHA if it determines that an HHA has a condition-level noncompliance and CMS determines that management limitations or the deficiencies are likely to impair the HHA's ability to correct deficiencies and return the HHA to full compliance with the conditions of participation within the timeframe required.
(2) [Reserved]
(b) Procedures. (1) CMS notifies the HHA that a temporary manager is being appointed.
(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. Temporary management continues until—
(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. (1) The temporary manager's 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. (1) CMS may suspend payment for all new admissions if an HHA is found to have condition-level deficiencies, regardless of whether those deficiencies pose immediate jeopardy.
(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 —(1) Notices. (i) Before suspending payments for new admissions, CMS provides the HHA notice of the suspension of payment for all new admissions as set forth in § 488.810(f). The CMS notice of suspension will include the nature of the noncompliance; the effective date of the sanction; and the right to appeal the determination leading to the sanction.
(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. (i) Suspension of payment for all new admissions sanction may be imposed anytime an HHA is found to be out of substantial compliance.
(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. Payments to the HHA resume prospectively on the date that CMS determines that the HHA has achieved substantial compliance with the conditions of participation.
(c) Duration and effect of sanction. This sanction ends when—
(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. (1) CMS may impose a civil money penalty against an HHA for either the number of days the HHA is not in compliance with one or more conditions of participation or for each instance that an HHA is not in compliance, regardless of whether the HHA's deficiencies pose immediate jeopardy.
(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 —(1) Factors considered. CMS takes into account the following factors in determining the amount of the penalty:
(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. Based on revisit survey findings, adjustments to penalties may be made after a review of the provider's attempted correction of deficiencies.
(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. Penalties in the upper range of $8,500 to $10,000 as adjusted under 45 CFR part 102 per day of noncompliance are imposed for a condition-level deficiency that is immediate jeopardy. The penalty in this range will continue until compliance can be determined based on a revisit survey.
(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. Penalties in the range of $1,500-$8,500 as adjusted annually under 45 CFR part 102 per day of noncompliance are imposed for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes.
(5) Lower range of penalty. Penalties in this range of $500-$4,000 as adjusted annually under 45 CFR part 102 are imposed for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that are related predominately to structure or process-oriented conditions (such as OASIS submission requirements) rather than directly related to patient care outcomes.
(6) Per instance penalty. Penalty imposed per instance of noncompliance may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey. When penalties are imposed for per instance of noncompliance, or more than one per instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 as adjusted annually under 45 CFR part 102 per instance, not to exceed $10,000 as adjusted annually under 45 CFR part 102 each day of noncompliance.
(7) Decreased penalty amounts. If the immediate jeopardy situation is removed, but condition-level noncompliance continues, CMS will shift the penalty amount imposed per day from the upper range to the middle or lower range. An earnest effort to correct any systemic causes of deficiencies and sustain improvement must be evident.
(8) Increased penalty amounts. (i) In accordance with paragraph (b)(2) of this section, CMS will increase the per day penalty amount for any condition-level deficiency or deficiencies which, after imposition of a lower-level penalty amount, become sufficiently serious to pose potential harm or immediate jeopardy.
(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 —(1) Notice of intent. CMS provides the HHA with written notice of the intent to impose a civil money penalty. The notice includes the amount of the CMP being imposed, the basis for such imposition and the proposed effective date of the sanction.
(2) Appeals —(i) Appeals procedures. An HHA may request a hearing on the determination of the noncompliance that is the basis for imposition of the civil money penalty. The request must meet the requirements in § 498.40 of this chapter.
(ii) Waiver of a hearing. An HHA may waive the right to a hearing, in writing, within 60 days from the date of the notice imposing the civil money penalty. If an HHA timely waives its right to a hearing, CMS reduces the penalty amount by 35 percent, and the amount is due within 15 days of the HHAs agreeing in writing to waive the hearing. If the HHA does not waive its right to a hearing in accordance to the procedures specified in this subsection, the civil money penalty is not reduced by 35 percent.
(d) Accrual and duration of penalty. (1)(i) The per day civil money penalty may start accruing as early as the beginning of the last day of the survey that determines that the HHA was out of compliance, as determined by CMS.
(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. (i) In the case of noncompliance that poses immediate jeopardy, CMS must terminate the provider agreement within 23 calendar days after the last day of the survey if the immediate jeopardy is not removed.
(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. (i) In the case of noncompliance that does not pose immediate jeopardy, the daily accrual of per day civil money penalties is imposed for the days of noncompliance prior to the notice specified in paragraph (c)(1) of this section and an additional period of no longer than 6 months following the last day of the survey.
(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. (1) When a civil money penalty is imposed on a per day basis and the HHA achieves compliance with the conditions of participation as determined by a revisit survey, CMS sends a final notice to the HHA containing all of the following information:
(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. A penalty is due and payable 15 days from notice of the final administrative decision.
(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 —(1) Disbursement of CMPs. Civil money penalties and any corresponding interest collected by CMS from Medicare and Medicaid participating HHAs are disbursed in proportion to average dollars spent by Medicare and Medicaid at the national level based on MSIS and HHA PPS data for a three year fiscal period.
(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. When an administrative law judge or state hearing officer (or higher administrative review authority) finds that the basis for imposing a civil monetary penalty exists, as specified in this part, the administrative law judge, State hearing officer (or higher administrative review authority) may not—
(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.
§ 488.850   Directed plan of correction.
(a) Application. CMS may impose a directed plan of correction when an HHA:
(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. (1) Before imposing this sanction, CMS provides the HHA notice of the impending sanction.
(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. If the HHA fails to achieve compliance with the conditions of participation within the timeframes specified in the directed plan of correction, CMS:
(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. CMS may require the staff of an HHA to attend in-service training program(s) if CMS determines that—
(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 —(1) Action following training. After the HHA staff has received in-service training, if the HHA has not achieved compliance, CMS may impose one or more other sanctions specified in § 488.820.
(2) Payment. The HHA pays for the directed in-service training for its staff.
§ 488.860   Continuation of payments to an HHA with deficiencies.
(a) Continued payments. CMS may continue payments to an HHA with condition-level deficiencies that do not constitute immediate jeopardy for up to 6 months from the last day of the survey if the criteria in paragraph (a)(1) of this section are met.
(1) Criteria. CMS may continue payments to an HHA not in compliance with the conditions of participation for the period specified in paragraph (a) of this section if all of the following criteria are met:
(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. If termination is imposed, either on its own or in addition to an alternative sanction or sanctions, or if any of the criteria set forth in paragraph (a)(1) of this section are not met, the HHA will receive no Medicare payments, as applicable, for new admissions following the last day of the survey.
(c) Failure to achieve compliance with the conditions of participation. If the HHA does not achieve compliance with the conditions of participation by the end of the period specified in paragraph (a) of this section, CMS will terminate the provider agreement of the HHA in accordance with § 488.865.
§ 488.865   Termination of provider agreement.
(a) Effect of termination by CMS. Termination of the provider agreement ends—
(1) Payment to the HHA; and
(2) Any alternative sanction(s).
(b) Basis for termination. CMS terminates an HHA's provider agreement under any one of the following conditions—
(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. CMS notifies the HHA and the public of the termination, in accordance with procedures set forth in § 489.53 of this chapter.
(d) Procedures for termination. CMS terminates the provider agreement in accordance with procedures set forth in § 489.53 of this chapter.
(e) Appeal. An HHA may appeal the termination of its provider agreement by CMS in accordance with part 498 of this chapter.
§ 488.1000   Basis and scope.
(a) Regulatory basis for home infusion therapy services. The home infusion therapy health and safety regulations are codified at part 486, subpart I, of this chapter.
(b) Statutory basis for the accreditation of home infusion therapy suppliers. (1) Sections 1102 and 1871 of the Act require that the Secretary prescribe such regulations as may be necessary to carry out the administration of the Medicare program.
(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. This subpart sets forth the following:
(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 means a situation in which the provider's or supplier's non-compliance with one or more Medicare accreditation requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient.
National accrediting organization means an organization that accredits provider or supplier entities under a specific program and whose accredited provider or supplier entities under each program are widely dispersed geographically across the United States. In addition, the specific program is active, fully implemented, and operational.
National in scope means a program is fully implemented, operational, and widely dispersed geographically throughout the country.
Qualified home infusion therapy supplier means a supplier of home infusion therapy that meets the all of the following criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act:
(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 means an accrediting organization has demonstrated to CMS' satisfaction that its accreditation program requirements meet or exceed the Medicare program requirements.
Rural area as defined at section 1886(d)(2)(D) of the Act.
Substantial allegation of non-compliance means a complaint from any of a variety of sources (such as patient, relative, or third party), including complaints submitted in person, by telephone, through written correspondence, or in the newspaper, magazine articles or other media, that would, if found to be present, adversely affect the health and safety of patients and raises doubts as to a qualified home infusion therapy supplier's compliance with the applicable Medicare accreditation requirements.
§ 488.1010   Application and reapplication procedures for national home infusion therapy accrediting organizations.
(a) Information submitted with application. A national home infusion therapy accrediting organization applying to CMS for approval or re-approval of a designated home infusion therapy accreditation program must furnish CMS with information and materials that demonstrate that its home infusion therapy accreditation program requirements meet or exceed the applicable Medicare requirements for accrediting organizations, including the following:
(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 ) Accredited home infusion therapy supplier identifying information.
( 2 ) Survey findings.
( 3 ) Quality measures.
( 4 ) Notices of accreditation decisions.
(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. Provide written notification to CMS and all home infusion therapy suppliers accredited under its CMS-approved home infusion therapy accreditation program at least 180 calendar days in advance of the effective date of a decision by the home infusion therapy accrediting organization to voluntarily terminate its CMS-approved home infusion therapy accreditation program and the implications for the suppliers' payment status once their current term of accreditation expires in accordance with the requirements at § 488.1045(a).
(ii) Involuntary termination. Provide written notification to all accredited home infusion therapy suppliers accredited under its CMS-approved home infusion therapy accreditation program no later than 30 calendar days after the notice is published in the Federal Register announcing that CMS is withdrawing its approval of its accreditation program and the implications for the home infusion therapy supplier's payment status in accordance with the requirements at § 488.1045(b) once their current term of accreditation expires.
(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. Provide, on an annual basis, summary accreditation activity data and trends including the following:
(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. If CMS terminates a home infusion therapy accrediting organization's approved status, the home infusion therapy accrediting organization must work collaboratively with CMS to direct its accredited home infusion therapy suppliers to the remaining CMS-approved accrediting organizations within a reasonable period of time.
(v) Notification of proposed changes. Notify CMS at least 60 days in advance of the implementation date of any significant proposed changes in its CMS-approved home infusion therapy 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 § 488.1040(b)(2).
(vi) Response to a written notice from CMS. A statement acknowledging that, in response to a written notice from CMS to the home infusion therapy accrediting organization of a change in the applicable home infusion therapy accreditation requirements or survey process, the organization will provide CMS with proposed corresponding changes in the accrediting organization's home infusion therapy accreditation requirements for its CMS-approved home infusion therapy accreditation program to ensure that its accreditation standards continue to meet or exceed those of Medicare, or survey process remains comparable with that of Medicare. The home infusion therapy accrediting organization must comply with the following requirements:
(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. If CMS determines that additional information is necessary to make a determination for approval or denial of the home infusion therapy accrediting organization's initial application or re-application for CMS-approval of an accreditation program, CMS requires that the home infusion therapy accrediting organization s submit any specific documentation requirements and attestations as a condition of approval of accreditation status. CMS notifies the home infusion therapy accrediting organization and afford it an opportunity to provide the additional information.
(c) Withdrawing an application. A home infusion therapy accrediting organization may withdraw its initial application for CMS' approval of its home infusion therapy accreditation program at any time before CMS publishes the final notice described in § 488.1025(b).
(d) Notice of approval or disapproval of application. CMS sends a notice of its decision to approve or disapprove the home infusion therapy accrediting organization's application within 210 calendar days from the date CMS determines the home infusion therapy accrediting organization's application is complete. The final notice specifies the following:
(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 when the following conditions are met:
(a) Proposed notice. CMS publishes a notice after the receipt of a completed application from a national home infusion therapy accrediting organization seeking CMS's approval of a home infusion therapy accreditation program. The notice identifies the home infusion therapy accrediting organization, the type of suppliers covered by the home infusion therapy accreditation program, and provides at least a 30 day public comment period (beginning on the date of publication).
(b) Final notice. The final notice announces CMS decision to approve or deny a national accrediting organization application. The notice specifies the basis for the CMS decision.
(1) Approval or re-approval. If CMS approves or re-approves the home infusion therapy accrediting organization's home infusion therapy accreditation program, the final notice at a minimum includes the following information:
(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. If CMS does not approve the home infusion therapy accrediting organization's accreditation program, the final notice describes the following:
(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. CMS evaluates the performance of each CMS-approved home infusion therapy accreditation program on an ongoing basis. This review includes the review of the following:
(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. CMS assesses the equivalency of a home infusion therapy accrediting organization's CMS-approved program requirements with the comparable Medicare home infusion therapy accreditation requirements after CMS imposes new or revised Medicare accreditation requirements. When this occurs, the following takes place:
(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. When a home infusion therapy accrediting organization proposes to adopt new or revised accreditation standards, requirements or changes in its survey process, the home infusion therapy accrediting organization must do the following:
(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. If a comparability, performance, or standards review reveals evidence of substantial non-compliance of a home infusion therapy accrediting organization's CMS-approved home infusion therapy accreditation program with the requirements of this subpart, CMS may initiate a 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 a notice of its decision to withdraw approval of a CMS-approved accreditation program, including the reasons for the withdrawal, effective 60 calendar days after the date of publication of the notice.
(e) Immediate jeopardy. If at any time CMS determines that the continued approval of a CMS-approved home infusion therapy accreditation program of any home infusion therapy accrediting organization poses an immediate jeopardy to the patients of the suppliers accredited under the program, or the continued approval otherwise constitutes a significant hazard to the public health, CMS may immediately withdraw the approval of a CMS-approved home infusion therapy accreditation program of that home infusion therapy accrediting organization and publish a notice of the removal, including the reasons for it, in the Federal Register .
(f) Notification to home infusion therapy suppliers of withdrawal of CMS approval status. A home infusion therapy accrediting organization whose CMS approval of its home infusion therapy accreditation program has been withdrawn must notify each of its accredited home infusion therapy suppliers, in writing, of the withdrawal of CMS approval status no later than 30 calendar days after the notice is published in the Federal Register. The notification to the accredited home infusion therapy suppliers must inform them of the implications for their payment status once their current term of accreditation expires.
(g) Change of ownership. An accrediting organization that wishes to undergo a change of ownership is subject to the requirements set out at § 488.5(f).
§ 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. In accordance with § 488.1010(a)(23), a home infusion therapy accrediting organization that decides to voluntarily terminate its CMS-approved home infusion therapy accreditation program must provide written notice at least 180 days in advance of the effective date of the termination to CMS and each of its accredited home infusion therapy suppliers.
(b) Involuntary termination of an accrediting organization's approval by CMS. Once CMS publishes the notice in the Federal Register announcing its decision terminate the home infusion therapy accrediting organization's home infusion therapy accreditation program, the home infusion therapy accrediting organization must provide written notification to all suppliers accredited under its CMS-approved home infusion therapy accreditation program no later than 30 calendar days after the notice is published in the Federal Register announcing that CMS is withdrawing its approval of its home infusion therapy accreditation program and the implications for the home infusion therapy suppliers payment status in accordance with the requirements at § 488.1010(f) once their current term of accreditation expires.
(c) Voluntary and involuntary terminations. For both 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. If a voluntary withdrawal from accreditation is requested by the home infusion therapy supplier, the withdrawal may not become effective until the accrediting organization completes all of the following steps:
(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. A home infusion therapy accrediting organization dissatisfied with a determination that its home infusion therapy accreditation requirements do not provide or do not continue to provide reasonable assurance that the suppliers accredited by the home infusion therapy accrediting organization meet the applicable quality standards is entitled to reconsideration.
(b) Filing requirements. (1) A written request for reconsideration must be filed within 30 calendar days of the receipt of CMS notice of an adverse determination or non-renewal.
(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. In response to a request for reconsideration, CMS provides the accrediting organization with—
(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. (1) The reconsideration hearing is a public hearing open to all of the following:
(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.
§ 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 means a focused survey other than a standard survey that gathers information on hospice program's compliance with specific standards or conditions of participation. An abbreviated standard survey may be based on complaints received or other indicators of specific concern.
Complaint survey means a survey that is conducted to investigate substantial allegations of noncompliance as defined in § 488.1.
Condition-level deficiency means noncompliance as described in § 488.24.
Deficiency is a violation of the Act and regulations contained in part 418, subparts C and D, of this chapter, is determined as part of a survey, and can be either standard or condition-level.
Hospice Special Focus Program (SFP) means a program conducted by CMS to identify hospices as poor performers, based on defined quality indicators, in which CMS selects hospices for increased oversight to ensure that they meet Medicare requirements. Selected hospices either successfully complete the SFP program or are terminated from the Medicare program.
IDR stands for informal dispute resolution.
Noncompliance means any deficiency found at the condition-level or standard-level.
SFP status means the status of a hospice provider in the SFP with respect to the provider's progress in the SFP, which is indicated by one of the following status levels:
(1) Level 1—in progress.
(2) Level 2—completed successfully.
(3) Level 3—terminated from the Medicare program.
SFP survey means a standard survey as defined in this section and is performed after a hospice is selected for the SFP and is conducted every 6 months, up to 3 occurrences.
Standard-level deficiency means noncompliance with one or more of the standards that make up each condition of participation for hospice programs.
Standard survey means a survey conducted in which the surveyor reviews the hospice program's compliance with a select number of standards or conditions of participation or both to determine the quality of care and services furnished by a hospice program.
Substantial compliance means compliance with all condition-level requirements, as determined by CMS or the State.
§ 488.1110   Hospice program: surveys and hotline.
(a) Basic period. Each hospice program as defined in section 1861(dd) of the Act is subject to a standard survey by an appropriate State or local survey agency, or an approved accreditation agency, as determined by the Secretary, not less frequently than once every 36 months. Additionally, a survey may be conducted as frequently as necessary to -
(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. A standard survey, or abbreviated standard survey-
(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. Surveyors must meet minimum qualifications prescribed by CMS. Before any accrediting organization, State or Federal surveyor may serve on a hospice survey team (except as a trainee), he/she must have successfully completed the relevant CMS-sponsored Basic Hospice Surveyor Training Course, and additional training as specified by CMS.
(b) Disqualifications. Surveyor(s) must disclose actual or perceived conflicts of interest prior to participating in a hospice program survey and be provided the opportunity to recuse themselves as necessary. Any of the following circumstances disqualifies a surveyor from surveying a particular hospice program:
(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. Upon the provider's receipt of an official statement of deficiencies, hospice programs can request an informal opportunity to dispute condition-level survey findings.
(b) Failure to conduct IDR timely. Failure of CMS, the State, or the AO, as appropriate, to complete IDR must not delay the effective date of any enforcement action.
(c) Revised statement of deficiencies as a result of IDR. If any findings are revised or removed by CMS, the State, or the AO based on IDR, the official statement of deficiencies is revised accordingly, and any enforcement actions imposed solely as a result of those cited deficiencies are adjusted accordingly.
(d) Notification. (1) If the survey findings indicate a condition-level deficiency, the hospice program is notified in writing of its opportunity for participating in an IDR process at the time the official statement of deficiencies is issued.
(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.
§ 488.1135   Hospice Special Focus Program (SFP).
(a) Applicability. (1) The provisions of this section are effective on or after January 1, 2024. ; and
(2) SFP selection begins in CY 2024.
(b) Selection criteria. (1) Selection of hospices for the SFP is made based on the highest aggregate scores based on the algorithm used by CMS.
(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. A hospice in the SFP—
(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. A hospice in the SFP that has two SFP surveys within 18 months with no condition-level deficiencies, and that has no pending complaint survey triaged at an immediate jeopardy or condition level, or that has returned to substantial compliance with all requirements may complete the SFP.
(e) Termination criteria. (1) A hospice in the SFP that does not meet the SFP completion requirements in paragraph (d) of this section is considered for termination from the Medicare program in accordance with 42 CFR 489.53.
(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. CMS posts all of the following at least annually on a CMS public-facing website:
(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.
§ 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 means CMS or the temporary manager (with CMS/survey agency (SA) approval) may direct the hospice program to take specific corrective action to achieve specific outcomes within specific timeframes.
Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient(s).
New admission means an individual who becomes a patient or is readmitted to the hospice program on or after the effective date of a suspension of payment remedy.
Per instance means a single event of noncompliance identified and corrected during a survey, for which the statute authorizes CMS to impose a remedy.
Plan of correction means a plan developed by the hospice program and approved by CMS that is the hospice program's written response to survey findings detailing corrective actions to cited deficiencies and specifies the date by which those deficiencies will be corrected.
Repeat deficiency means a condition-level deficiency that is cited on the current survey and is substantially the same as or similar to, a finding of a standard-level or condition-level deficiency cited on the most recent previous standard survey or on any intervening survey since the most recent standard survey. Repeated non-compliance is not on the basis that the exact regulation (that is, tag number) for the deficiency was repeated.
Temporary management means the temporary appointment by CMS or by a CMS authorized agent, of a substitute manager or administrator. The hospice program's governing body must ensure that the temporary manager has authority to hire, terminate or reassign staff, obligate funds, alter procedures, and manage the hospice program to correct deficiencies identified in the hospice program's operation.
§ 488.1210   General provisions.
(a) Purpose of remedies. The purpose of remedies is to ensure prompt compliance with program requirements in order to protect the health and safety of individuals under the care of a hospice program.
(b) Basis for imposition of remedies. When CMS chooses to apply one or more remedies specified in § 488.1220, the remedies are applied on the basis of noncompliance with one or more conditions of participation and may be based on failure to correct previous deficiency findings as evidenced by repeat condition-level deficiencies.
(c) Number of remedies. CMS may impose one or more remedies specified in § 488.1220 for each condition-level deficiency constituting noncompliance.
(d) Plan of correction requirement. Regardless of which remedy is applied, a non-compliant hospice program must submit a plan of correction for approval by CMS or the State Survey Agency.
(e) Notification requirements —(1) Notice of intent. CMS provides written notification to the hospice program of the intent to impose the remedy, the statutory basis for the remedy, the nature of the noncompliance, the proposed effective date of the sanction, and the appeal rights. For civil money penalties, the notice of intent would also include the amount being imposed.
(2) Final notice. With respect to civil money penalties, CMS provides a written final notice to the hospice program, as set forth in § 488.1245(e), once the administrative determination is final.
(3) Date of enforcement action. The notice periods specified in §§ 488.1225(b) and 488.1230(b) begin the day after the hospice receives the notice of intent.
(f) Appeals. (1) The hospice program may request a hearing on a determination of noncompliance leading to the imposition of a remedy, including termination of the provider agreement, under the provisions of part 498 of this chapter.
(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. If there is immediate jeopardy to the hospice program's patient health or safety, the following rules apply:
(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. Except for civil money penalties, for all remedies specified in § 488.1220 imposed when there is immediate jeopardy, notice must be given at least 2 calendar days before the effective date of the enforcement action. The requirements of the notice are set forth in § 488.1210(e).
(c) Transfer of care. A hospice program, if its provider agreement is terminated, is responsible for providing information, assistance, and arrangements necessary for the proper and safe transfer of patients to another local hospice program within 30 calendar days of termination.
§ 488.1230   Action when deficiencies are at the condition-level but do not pose immediate jeopardy.
(a) Noncompliance with conditions of participation. If the hospice program is no longer in compliance with the conditions of participation, either because the condition-level deficiency or deficiencies substantially limit the provider's capacity to furnish adequate care but do not pose immediate jeopardy, or the hospice program has repeat condition-level deficiencies based on the hospice program's failure to correct and sustain compliance, CMS does either of the following.
(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. Except for civil money penalties, for all remedies specified in § 488.1220 imposed when there is no immediate jeopardy, notice must be given at least 15 calendar days before the effective date of the enforcement action. The requirements of the notice are set forth in § 488.1210(e).
(c) Not meeting criteria for continuation of payment. If a hospice program does not meet the criteria for continuation of payment under § 488.1260(a), CMS terminates the hospice program's provider agreement in accordance with § 488.1265.
(d) Termination timeframe when there is no immediate jeopardy. CMS terminates a hospice program within 6 months of the last day of the survey, if the hospice program is not in compliance with the conditions of participation, and the terms of the plan of correction have not been met.
(e) Transfer of care. A hospice program, if its provider agreement terminated, is responsible for providing information, assistance, and arrangements necessary for the proper and safe transfer of patients to another local hospice program within 30 calendar days of termination. The State must assist the hospice program in the safe and orderly transfer of care and services for the patients to another local hospice program.
§ 488.1235   Temporary management.
(a) Application. CMS may impose temporary management of a hospice program if it determines that a hospice program has a condition-level deficiency and CMS determines that management limitations or the deficiencies are likely to impair the hospice program's ability to correct the noncompliance and return the hospice program to compliance with all of the conditions of participation within the timeframe required.
(b) Procedures —(1) Notice of intent. Before imposing the remedy in paragraph (a) of this section, CMS notifies the hospice program in accordance with § 488.1210(e) that a temporary manager is being appointed.
(2) Termination. If the hospice program fails to relinquish authority and control to the temporary manager, CMS terminates the hospice program's provider agreement in accordance with § 488.1265.
(c) Duration and effect of remedy. Temporary management continues until one of the following occur:
(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. (1) The temporary manager's salary must meet the following:
(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. (1) CMS may suspend payment for all new admissions to a hospice program on or after the date on which the Secretary determines that remedies should be imposed.
(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 —(1) Notice of intent. (i) Before suspending payments for all new admissions, CMS provides the hospice program notice of the suspension of payment in accordance with § 488.1210(e).
(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. (i) The suspension of payment for all new admissions remedy may be imposed anytime a hospice program is found to be out of substantial compliance with the conditions of participation.
(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. Payments for all new admissions to the hospice program resume prospectively on the date that CMS determines that the hospice program has achieved substantial compliance with the conditions of participation.
(c) Duration and effect of remedy. The remedy in paragraph (a) of this section ends when any of the following occur—
(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. (1) CMS may impose a civil money penalty against a hospice program for either the number of days the hospice program is not in compliance with one or more conditions of participation or for each instance that a hospice program is not in compliance, regardless of whether the hospice program's deficiencies pose immediate jeopardy.
(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 —(1) Factors considered. CMS takes into account the following factors in determining the amount of the penalty:
(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. Based on revisit survey findings, adjustments to penalties may be made after a review of the provider's attempted correction of deficiencies.
(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. Penalties in the upper range of $8,500 to $10,000 per day, as adjusted annually under 45 CFR part 102, are imposed for a condition-level deficiency that is immediate jeopardy. The penalty in this range continues until substantial compliance can be determined based on a revisit survey.
(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. Penalties in the range of $1,500 up to $8,500, as adjusted annually under 45 CFR part 102, per day of noncompliance are imposed for a repeat or condition-level deficiency or both that does not constitute immediate jeopardy but is directly related to poor quality patient care outcomes.
(5) Lower range of penalty. Penalties in this range of $500 to $4,000, as adjusted annually under 45 CFR part 102, are imposed for a repeat or condition-level deficiency or both that does not constitute immediate jeopardy and that are related predominately to structure or process-oriented conditions rather than directly related to patient care outcomes.
(6) Per instance penalty. Penalty imposed per instance of noncompliance may be assessed for one or more singular events of condition-level deficiency that are identified and where the noncompliance was corrected during the onsite survey. When penalties are imposed for per instance of noncompliance, or more than one per instance of noncompliance, the penalties will be in the range of $1,000 to $10,000 per instance, not to exceed $10,000 each day of noncompliance, as adjusted annually under 45 CFR part 102.
(7) Decreased penalty amounts. If the immediate jeopardy situation is removed, but a condition-level deficiency exists, CMS shifts the penalty amount imposed per day from the upper range to the middle or lower range. An earnest effort to correct any systemic causes of deficiencies and sustain improvement must be evident.
(8) Increased penalty amounts. (i) In accordance with paragraph (b)(2) of this section, CMS increases the per day penalty amount for any condition-level deficiency or deficiencies which, after imposition of a lower-level penalty amount, become sufficiently serious to pose potential harm or immediate jeopardy.
(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 —(1) Notice of intent. CMS provides the hospice program with written notice of the intent to impose a civil money penalty in accordance with § 488.1210(e).
(2) Appeals —(i) Appeals procedures. A hospice program may request a hearing on the determination of the noncompliance that is the basis for imposition of the civil money penalty. The request must meet the requirements in § 498.40 of this chapter.
(ii) Waiver of a hearing. A hospice program may waive the right to a hearing, in writing, within 60 calendar days from the date of the notice imposing the civil money penalty. If a hospice program timely waives its right to a hearing, CMS reduces the penalty amount by 35 percent, and the amount is due within 15 calendar days of the hospice program agreeing in writing to waive the hearing. If the hospice program does not waive its right to a hearing in accordance to the procedures specified in this section, the civil money penalty is not reduced by 35 percent.
(d) Accrual and duration of penalty —(1) Accrual of per day penalty. (i) The per day civil money penalty may start accruing as early as the beginning of the last day of the survey that determines that the hospice program was out of compliance, as determined by CMS.
(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. (i) In the case of noncompliance that poses immediate jeopardy, CMS must terminate the provider agreement within 23 calendar days after the last day of the survey if the immediate jeopardy is not removed.
(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. (i) In the case of noncompliance that does not pose immediate jeopardy, the daily accrual of per day civil money penalties is imposed for the days of noncompliance prior to the notice of intent specified in paragraph (c)(1) of this section and an additional period of no longer than 6 months following the last day of the survey.
(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. (1) When a civil money penalty is imposed on a per day basis and the hospice program achieves compliance with the conditions of participation as determined by a revisit survey, once the administrative determination is final, CMS sends a final notice to the hospice program containing of the following information:
(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. A penalty is due and payable 15 calendar days from notice of the final administrative decision.
(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. When an administrative law judge finds that the basis for imposing a civil monetary penalty exists, as specified in this part, the administrative law judge, may not do any of the following:
(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. CMS may impose a directed plan of correction when a hospice program—
(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. (1) Before imposing the remedy in paragraph (a) of this section, CMS notifies the hospice program in accordance with § 488.1210(e).
(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. If the hospice program fails to achieve compliance with the conditions of participation within the timeframes specified in the directed plan of correction, which may not to exceed 6 months, CMS does one of the following:
(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. CMS may require the staff of a hospice program to attend in-service training program(s) if CMS determines all of the following:
(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 —(1) Notice of intent. Before imposing the remedy in paragraph (a) of this section, CMS notifies the hospice program in accordance with § 488.1210(e).
(2) Action following training. After the hospice program staff has received in-service training, if the hospice program has not achieved substantial compliance, CMS may impose one or more other remedies specified in § 488.1220.
(3) Payment. The hospice program pays for the directed in-service training for its staff.
§ 488.1260   Continuation of payments to a hospice program with deficiencies.
(a) Continued payments. CMS may continue payments to a hospice program with condition-level deficiencies that do not constitute immediate jeopardy for up to 6 months from the last day of the survey if the criteria in paragraph (a)(1) of this section are met.
(1) Criteria. CMS may continue payments to a hospice program not in compliance with the conditions of participation for the period specified in paragraph (a) of this section if all of the following criteria are met:
(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. CMS may terminate the hospice program'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. If termination is imposed, either on its own or in addition to an enforcement remedy or remedies, or if any of the criteria set forth in paragraph (a)(1) of this section are not met, the hospice program will receive no Medicare payments, as applicable, for new admissions following the last day of the survey.
(c) Failure to achieve compliance with the conditions of participation. If the hospice program does not achieve compliance with the conditions of participation by the end of the period specified in paragraph (a) of this section, CMS terminates the provider agreement of the hospice program in accordance with § 488.1265.
§ 488.1265   Termination of provider agreement.
(a) Effect of termination by CMS. Termination of the provider agreement ends—
(1) Payment to the hospice program; and
(2) Any enforcement remedy.
(b) Basis for termination. CMS terminates a hospice program's provider agreement under any one of the following conditions:
(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. CMS notifies the hospice program and the public of the termination, in accordance with procedures set forth in § 489.53 of this chapter.
(d) Procedures for termination. CMS terminates the provider agreement in accordance with procedures set forth in § 489.53 of this chapter.
(e) Payment post termination. Payment is available for up to 30 calendar days after the effective date of termination for hospice care furnished under a plan established before the effective date of termination as set forth in § 489.55 of this chapter.
(f) Appeal. A hospice program may appeal the termination of its provider agreement by CMS in accordance with part 498 of this chapter.